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Document 52017SC0469

COMMISSION STAFF WORKING DOCUMENT REFIT EVALUATION Accompanying the document Proposal for a Regulation of the European Parliament and of the Council laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council

SWD/2017/0469 final - 2017/0353 (COD)

Brussels, 19.12.2017

SWD(2017) 469 final

COMMISSION STAFF WORKING DOCUMENT

REFIT EVALUATION

Accompanying the document

Proposal for a Regulation of the European Parliament and of the Council

laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council

{COM(2017) 795 final}
{SWD(2017) 466 final}
{SWD(2017) 467 final}
{SWD(2017) 468 final}
{SWD(2017) 470 final}


Contents

1.Introduction

2.Background to the initiative

2.1.Description of the initiative and its objectives

2.1.1.Objectives and roles of the market surveillance provisions

2.1.2.Scope of the evaluation

2.1.3.Complementary nature of the market surveillance provisions

2.2.Consumer Safety and Market Surveillance Package (2013)

2.3.Baseline

2.3.1.Regulatory aspects

2.3.2.Level of non-compliance in 2008

3.Evaluation Questions

4.Method

4.1.Sources

4.2.Limitations – robustness of findings

5.Implementation state of play (Results)

5.1.Market surveillance structures and measures

5.2.Additional information

5.2.1.Exchange of information (ICSMS, notifications of restrictive measures, national market surveillance programmes and reports on activities)

5.2.2.Cooperation

5.2.3.Infringement proceedings

6.Answers to the evaluation questions

6.1.Effectiveness

6.1.1.Enhanced cooperation among Member States

6.1.2.Uniform and sufficiently rigorous level of market surveillance

6.1.3.Border controls of imported products

6.1.4.Conclusion as regards EQ1

6.2.Efficiency

6.3.Relevance

6.4.Coherence

6.5.EU added value

7.Conclusions

7.1.Effectiveness

7.2.Efficiency

7.3.Relevance

7.4.Coherence

7.5.EU added value

7.6.REFIT potential



Glossary

Product

A substance, product or good produced through a manufacturing process other than food, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction (Article 15(4) of Regulation (EC) No 765/2008 or 'the Regulation').

Market surveillance provisions

Articles 15 to 29, Article 38 and Article 41 of Regulation (EC) No 765/2008 and the corresponding definitions and financing provisions,

Market surveillance

The activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection (Article 2(17) of the Regulation).

Market surveillance authority or MSA

An authority of a Member State responsible for carrying out market surveillance on its territory.

Union harmonisation legislation

Any Union legislation harmonising the conditions for the marketing of products (Article 2(21) of the Regulation).

Sector legislation

Legislation that is part of the Union harmonisation legislation.

GPSD

General Product Safety Directive - Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety

Manufacturer

Any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark (Article 2(3) of the Regulation).

Authorised representative

Any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter's obligations under the relevant Union legislation (Article 2(4) of the Regulation).

Importer

Any natural or legal person established within the Union who places a product from a third country on the Union market (Article 2(5) of the Regulation).

Distributor

Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market (Article 2(6) of the Regulation)

Economic operators

The manufacturer, the authorised representative, the importer and the distributor (Article 2(7) of the Regulation).

AdCo

The Administrative Coordination group of the authorities responsible for market surveillance with respect to one or more instruments of Union harmonisation legislation.

Recall

Any measure aimed at achieving the return of a product that has already been made available to the end user (Article 2(14) of the Regulation).

Withdrawal

Any measure aimed at preventing a product in the supply chain from being made available on the market (Article 2(15 of the Regulation)).

Making available on the market

Any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge (Article 2(1) of the Regulation)

Placing on the market

The initial making available of a product on the Union market (Article 2(2) of the Regulation).

RAPEX

Rapid alert system for the transmission among all competent market surveillance authorities in the EU of information on measures taken against products presenting a serious risk – ec.europa.eu/consumers/consumers_safety/safety_products/rapex/index_en.htm (system referred to in Article 22 of the Regulation).

ICSMS

Internet-supported information and communication system for market surveillance authorities in the EU - https://webgate.ec.europa.eu/icsms/ (system referred to in Article 23 of the Regulation).



1.Introduction

A large range of non-food consumer products (like toys, mobile phones, electrical appliances, laptops etc.) and more sophisticated products (e.g. machines, pressure equipment, measuring instruments, equipment to be used in explosive atmospheres etc.) sold on the Single Market are subject to common EU rules concerning public safety, security, environmental protection, etc. This set of rules is referred to as Union technical legislation.

Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (hereinafter also referred to as “the Regulation”) was adopted to address the lack of coherence in the implementation and enforcement of Union technical legislation ensuring the free movement of non-food products 1 (hereinafter also referred to as “products”) within the EU. The purpose of the Regulation is therefore to ensure that these products are subject to adequate controls by public authorities so that if found to be, for instance, dangerous for consumers, workers or the environment, they could be taken off the EU market promptly.

The Regulation has four main elements:

(1)It lays down rules on the organisation and operation of accreditation of conformity assessment bodies performing conformity assessment activities;

(2)It lays down the general principles of the CE marking;

(3)It provides a framework for the market surveillance of products to ensure that those products fulfil the requirements providing a high level of protection for public interests, such as health and safety in general, health and safety at the workplace, the protection of consumers and the protection of the environment and security.

(4)It provides a framework for controls on products from third countries.

This evaluation only relates to the third and fourth element above, i.e. the framework for the market surveillance of products and for controls on products from third countries 2 . Therefore, it focuses on Articles 15 to 29, Article 38 and Article 41 of the Regulation and the corresponding definitions and financial provisions of the Regulation (hereinafter 'market surveillance provisions').

The purpose of this evaluation is to assess the effectiveness, efficiency, coherence, relevance and EU added value of the market surveillance provisions on the basis of the evaluation questions set out in section 3. Its results feed into the impact assessment that will accompany the legislative proposal strengthening the enforcement of Union harmonisation legislation on products. This proposal is one of the deliverables of the Single Market Strategy 3 , according to which the Commission will 'launch a comprehensive set of actions to further enhance efforts to keep non-compliant products from the EU market by strengthening market surveillance and providing the right incentives to economic operators'.

This evaluation covers the period from 2010 (date of application of the Regulation) until 2015, compared to the situation before 2010. It is part of the Commission's work programme, according to which 'the Commission will act to strengthen the single market in goods, notably by facilitating the mutual recognition and addressing the increasing amount of non-compliant products on the EU market through REFIT revisions of the relevant legislation. This will allow entrepreneurs to offer their products more easily across borders while offering incentives to boost regulatory compliance and restoring a level playing field to the benefit of businesses and citizens 4 .'

The findings of the evaluation suggest that while its main goal to ensure that products sold on EU market are safe and compliant with applicable rules remains extremely relevant, the Regulation has been only partly effective in achieving its objectives. As a consequence the legal framework for product controls and its implementation should be further improved.

2.Background to the initiative

2.1.Description of the initiative and its objectives

2.1.1.Objectives and roles of the market surveillance provisions

The intervention logic of Regulation (EC) No 765/2008 could be summarised as follows 5 . Three main needs or drivers led to the definition of the Regulation’s strategic objectives: (1) to address the lack of market surveillance enforcement within the EU; (2) to increase credibility of CE marking in the internal market; and (3) to ensure the free movement of goods within the EU, together with product safety and the protection of public interests. The two strategic objectives of the Regulation – aiming to respond to the abovementioned needs - are to (1) ensure a level playing field among economic operators through the elimination of unfair competition of non-compliant products and to (2) strengthen the protection of public interests through the reduction of the number of non-compliant products 6 . The strategic objectives are then disaggregated into three specific objectives representing the operational orientations of the EU action. In order to achieve the strategic and specific objectives, the EC has defined a set of activities to be implemented, including those in the Regulation in the form of provisions. For instance, in order to achieve a reduction in the number of non-compliant products, the Regulation sets the framework for controls of products on the internal market (Ch. III, section 2) and of those imported from third countries (Ch. III, section 3). These provisions are expected to produce a number of key results and to eventually trigger the Regulation’s impacts. For instance, the resulting lower number of non-compliant products will generate a higher and more uniform protection of consumers across the EU.

The figure below outlines the Regulation’s intervention logic in relation to the evaluation criteria and questions that guided the study and that will be further described in the following chapter. The arrows represent the links/trigger mechanisms between needs and objectives, and objectives, provisions and results.

The intervention logic below also presents the evaluation questions (and related criteria) helping in the assessment of the overall performance of the market surveillance provisions, having identified its working mechanisms. As shown in the figure below, the evaluation questions relating to relevance assess whether the objectives of the market surveillance provisions are still adequate in the current context. The effectiveness questions are based on measurements of the market surveillance provisions’ results to determine whether it has achieved its objectives. The efficiency questions assess whether the market surveillance provisions have proportionally delivered their results, given the established provisions. In order to better understand how the interaction among the above elements works and delivers the expected changes over time, the intervention logic needs to consider external factors (including other EU legislation) that may influence the performance of the market surveillance provisions: the coherence questions evaluate whether these provisions are consistent with those factors. The EU added value questions aim at understanding if the provisions set out have served to obtain the expected impacts.

Figure 1: Intervention logic

2.1.2.Scope of the evaluation

This evaluation only relates to the market surveillance provisions, i.e. the following parts of the Regulation:

·Chapter I – General provisions: This Chapter specifies the scope of the Regulation and the main definitions relevant for market surveillance.

·Chapter III – EU market surveillance framework and controls of products entering the EU market. Chapter III covers the functioning of market surveillance of products subject to the EU harmonisation legislation. It defines the products covered by the market surveillance infrastructures and programmes, as well as the roles and responsibilities of the European Commission, Member States, national Market surveillance authorities and other relevant actors.

In particular, Section 1 defines the scope of application of the provisions on market surveillance and control of imported products. It also sets out the general obligation to carry out market surveillance and take restrictive measures for products found to be dangerous or in any case non-compliant in relation to any product categories subject to EU harmonisation law and to inform the European Commission and other Member States.

Section 2 “EU market surveillance framework” sets out the obligations of the EU MS regarding the organisation of national authorities and measures to be adopted in the case of products presenting a serious risk. The Section provides an overview of the duties of national Market surveillance authorities and their cooperation with competent authorities in other EU MS or in third countries. The Regulation also states the principles of cooperation and exchange of information between all relevant actors in the field of market surveillance.

Section 3 “Controls of products entering the EU market” entrusts powers and resources to authorities in charge of external border control of products entering the EU market and defines in which situations such authorities shall not release a product for free circulation or, in case of suspension, shall release the product. Moreover, Section 3 defines the measures to be taken by Market surveillance authorities if a product presents a serious risk or does not comply with the EU harmonisation legislation.

·Chapter V – EU Financing. Includes provisions on the financing system for obtaining the results expected by the Regulation. More specifically, it lists the activities eligible for financing and the arrangements on financial procedures. The Regulation also foresees the possibility of covering administrative expenses for all management and monitoring activities necessary for the achievement of its objectives.

·Chapter VI – Final provisions. The last two provisions subject to the evaluation are Article 38, which refers to the possibility of the adoption by the EC of non-binding guidelines on the Regulation implementation, and Article 41, which obliges the EU MS to lay down rules on penalties for economic operators applicable to infringements of the provisions of this Regulation.

2.1.3.Complementary nature of the market surveillance provisions

Some market surveillance rules are laid down in sector specific Union legislation. They set out in detail how and when a market surveillance authority should intervene when a non-compliant product is found. Market surveillance authorities should check the compliance of the product with the legal requirements applicable at the moment of the placing of the market or, if relevant, putting into service. The first level of control are usually documentary and visual checks, for example regarding the CE marking and its affixing, the availability of the EU declaration of conformity, the information accompanying the product and the correct choice of conformity assessment procedures. More profound checks may be however necessary to verify the conformity of the product, for example regarding the correct application of the conformity assessment procedure, the compliance with the applicable essential requirements, and the contents of the EU declaration of conformity.

The market surveillance provisions in the Regulation complement and strengthen existing provisions in Union harmonisation legislation providing more general principles for the organisation and tools for the implementation of control activities. 7 The Regulation indicates that, in accordance with the principle of lex specialis, it should apply only in so far as there are no specific provisions with the same objective, nature or effect in other existing or future rules of Union harmonisation legislation. The corresponding provisions of the Regulation therefore do not apply in the areas covered by such specific provisions 8 .

The Regulation does not affect the substantive rules of existing Union legislation setting out the rules and procedures to be observed by authorities and businesses when market surveillance is performed, but it should nonetheless enhance their operation.

The complementarity between the market surveillance provisions in the Regulation and those in Union harmonisation legislation has been remarkably improving over the last years through the alignment of sector-specific rules to those of Decision No 768/2008/EC 9 , which was adopted together with the Regulation. The Decision includes reference provisions to be incorporated whenever product legislation is revised, working as a “template” for future product harmonisation legislation. The relation between the two sets of markets surveillance rules is illustrated in the following table. At the time of writing, several sector-specific directives and regulations were aligned with these reference provisions and further aligning proposals are pending 10 .

Table 1: Market surveillance provisions in Regulation (EC) No 765/2008 and new sector legislation

MARKET SURVEILLANCE MEASURES AND STRUCTURES

REGULA-TION (EC) No 765/2008

NEW SECTOR LEGISLATION 11

MARKET SURVEILLANCE PROCEDURES

Obligations of economic operators vis-à-vis market surveillance authorities (information and cooperation)

No

Yes

Identification of economic operators (obligation for economic operators to identify the economic operators who supplied the product and the economic operator to whom the product was supplied)

No

Yes

Definition of formal non-compliance (e.g. markings wrongly or not affixed, declaration of conformity missing, technical documentation not available or incomplete etc.)

No

Yes

Procedures for dealing with non-compliant products (i.e. corrective actions, information obligations, restrictive measures, recalls etc.)

No

Yes

Market surveillance measures (i.e. role of market surveillance authorities)

Yes

No but legislation refers to Regulation (EC) No 765/2008

Products presenting a serious risk (i.e. Member States must ensure that products which present a serious risk requiring rapid intervention, are recalled, withdrawn or that their being made available on their market is prohibited)

Restrictive measures (i.e. procedural safeguards, statement of reasons, right to be heard, remedies etc.)

Exchange of information — Rapid Information System for products presenting a serious risk

General information support system (ICSMS) on issues relating to market surveillance activities, programmes and related information on non-compliance with Union harmonisation legislation, including identification of risks, results of testing carried out, provisional restrictive measures taken, contacts with the economic operators concerned and justification for action or inaction

Union safeguard procedure

No

Yes

Procedure for compliant products which present a risk to health and safety

No

Yes

MARKET SURVEILLANCE STRUCTURES

General requirements for market surveillance

Yes

No but legislation refers to Regulation (EC) No 765/2008

Information obligations about market surveillance authorities

Obligations of the Member States as regards organisation of market surveillance

Principles of cooperation between the Member States and the Commission

Sharing of resources

Cooperation with the competent authorities of third countries

Controls of products entering the Union market

Release of products

National measures on products entering the Union market

Financing provisions for market surveillance

Yes

No

Penalties

Penalties for economic operators applicable to infringe-ments of the provisions of the Regulation

Penalties for economic operators applicable to infringements of the provisions of sector legislation

2.2.Consumer Safety and Market Surveillance Package (2013)

The Commission proposed in 2013 a major overhaul of the market surveillance framework for non-food products through a new single regulation on market surveillance 12 . Its aim was to combine the market surveillance rules currently spread across the Union harmonisation legislation. All products would be subject to the same rules except where the specific characteristics of a category of products would state otherwise. Furthermore, procedures for the notification by Member States of information about products presenting a risk and corrective measures taken would be streamlined.

However, the negotiations between the European Parliament, the Council and the Commission have stalled for a long time. In its session of 26-27 May 2016, the 'Council took note of a request made by eleven member states to renew efforts with a view to moving forward negotiations on the Consumer Safety/Market Surveillance package (8985/16). The package is currently blocked in the Council because of a proposed provision on the introduction of a mandatory marking of origin on industrial products, known as the "Made in" provision (article 7 of the Consumer Safety draft regulation 13 ). In March, eleven member states in favour of maintaining the "Made in" provision, presented a compromise proposal based on the deletion of article 7 and the introduction of mandatory marking of origin in a limited amount of sectorial legislation, combined with a revision clause. The presidency verified that positions within the Council remain unchanged 14 .' The discussions on this proposal were not resumed and it is reasonable to assume that any progress on this proposal in view of its adoption by the co-legislator is highly unlikely.

2.3.Baseline 

2.3.1.Regulatory aspects

Before the Regulation, the framework for product controls to assure their conformity with EU rules was incomplete and inhomogeneous 15 . This was based on:

·Regulation (EEC) No 339/93 that set up common procedures for controlling the products coming from non-EU countries but it did not contain an explicit obligation to carry out those controls;

·the General Product Safety Directive 2001/95/EC 16 (hereinafter 'GPSD') that exclusively concerns controls of conformity of consumer products with safety requirements, i.e. only part of EU acquis and

·few scattered provisions embedded in sector-specific EU harmonisation legislation.

Being the responsibility (and a prerogative) of Member States, enforcement only had an ancillary role in EU harmonisation legislation until the adoption of the Regulation. The harmonisation legislation that existed in 2007 did not in general address market surveillance. Most instruments contain a very general clause obliging Member States to ensure that only products in compliance with the requirements of the directive are placed on the market. In the New Approach directives the safeguard clause procedure obliged national authorities to notify the Commission whenever they take a measure restricting the free circulation of a potentially dangerous product. The Commission had to issue an opinion on whether the measure is justified or not.

In respect of consumer goods, these general provisions in the sector directives were completed by the provisions of the General Product Safety Directive 2001/95/EC ('GPSD'). The GPSD has created a horizontal framework ensuring the safety of consumer products. To this end it sets out a number of obligations for manufacturers, importers and distributors as well as certain obligations for Member States as regards the organisation of market surveillance. The GPSD also established a network of authorities of the Member States competent for product safety aimed at facilitating operational collaboration on market surveillance and other enforcement activities. Moreover, the GPSD set up a European rapid alert system for dangerous non-food products for the rapid exchange of information requiring rapid intervention (RAPEX). It ensures information about dangerous products identified in the Member States is quickly circulated between the Member States and the Commission. The GPSD applies to the harmonised sectors like toys, cosmetics, etc., in so far as the relevant harmonisation directives have themselves not provided for specific rules.

However, the mechanisms established by the GPSD were not sufficient to ensure a coherent level of enforcement of Union harmonisation legislation throughout the EU. While harmonisation legislation covers both consumer and non-consumer products, the GPSD focuses on consumer protection. Therefore, its mechanisms are not applicable to whole range of products covered by Union harmonisation legislation. Hence RAPEX did not allow for exchange of information on dangerous industrial products like machinery or lifts, which present a risk for workers or users. Furthermore only health and safety aspects were covered by this system, and environmental risks were not taken into consideration.

While the GPSD contains an obligation for Member States to take part in the cooperation mechanism, the obligations it imposes on Member States to organise and perform market surveillance are rather general. For this reason differences in the various Member States still continued to persist, leading to a different level of protection and enforcement within the EU 17 .

2.3.2.Level of non-compliance in 2008

According to the impact assessment of 2008, the share of non-compliant products could only be crudely estimated and the situation differed very much from sector to sector and from Member State to Member State. Nevertheless, the available information indicated that a significant proportion of the products on the market do not comply with the legal requirements. In 2004, for example, 33% of industrial products were found not to be in conformity with the legislation in Germany. The following table summarises the findings.

Table 2: Indications from stakeholders on the share of non-compliant products on the market in 2008.

Source

Share of non-compliant products on the market

SME Test panel

The majority of SMEs could not provide figures. Where figures were given, they differed considerably from sector to sector as well as between Member States. The figures ranged from 4%-51%, the average being 24%.

Enterprise questionnaire

Most respondents could not provide figures but indicated that the problem was important. However, below is an overview of the estimates provided:

Electro-technical sector: 10-30% (up to 50 % in the luminaires sector)

Mechanical sector: 5-7 %

Medical devices: 10-30%

Construction products: 10-30%

Market surveillance authorities

Electro-technical 10-70 %

Medical Devices 2-20 %,

Construction products 2-30 %

Recreational Craft 1 %

There are some indications in ICSMS, although the system was only used by a smaller group of Member States:

Table 3: Indications from stakeholders on the share of non-compliant products on the market.

Year

0 - No defects identified

1 - Low risk

2 - Medium risk

3 - High risk

4 - Serious risk

2008

574

1.034

1.153

927

0

2009

476

1.094

1.069

888

0

3.Evaluation Questions

The following box presents eighteen evaluation questions, framed within the five evaluation criteria that have been answered to assess the market surveillance provisions of the Regulation.

Effectiveness

EQ1.Are the results in line with what is foreseen in the impact assessment for the Regulation, notably as to the specific objectives of (i) enhanced cooperation among Member States/within Member States, (ii) uniform and sufficiently rigorous level of market surveillance, (iii) border controls of imported products?

EQ2.Are there specific forms of the implementation of the Regulation at Member State level that render certain aspects of the Regulation more or less effective than others, and – if there are – what lessons can be drawn from this?

EQ3.To what extent has the different implementation (i.e. discrepancies in the implementation) of the initiative in Member States impacted on the effectiveness of the measures on the objective?

EQ4.How effective was the measure as a mechanism and means to achieve a high level of protection of public interests, such as health and safety in general, health and safety at workplace, the protection of consumers, protection of the environment and security? What have been the quantitative and qualitative effects of the measure on its objectives?

EQ5.How effective was the measure as a mechanism and means to achieve a level playing field among businesses trading in goods subject to EU harmonisation legislation? What have been the quantitative and qualitative effects of the measure on its objectives?

Efficiency

EQ6.What are the regulatory (including administrative) costs for the different stakeholders (businesses, consumers/users, national authorities, Commission)?

EQ7.What are the main benefits for stakeholders and civil society that derive from the Regulation?

EQ8.To what extent have the market surveillance provisions been cost effective?

EQ9.Are there any significant differences in costs (or benefits) between Member States? If so, what is causing them?

Relevance

EQ10.To what extent are market surveillance provisions of the Regulation still relevant in light of for instance of increasing online trade, the increase in imports from third countries, shortening product life, increasing budgetary constraints at national level, etc.?

EQ11.To what extent do the effects of the market surveillance provisions satisfy (or not) stakeholders' needs? How much does the degree of satisfaction differ according to the different stakeholder groups?

EQ12.Is there an issue on the scope (i.e. all EU product harmonisation legislation) of the measure or some of its provisions?

EQ13.Is the concept of lex specialis still a suitable interface between the market surveillance provisions in the Regulation and those in other (notably sector) legislation?

Coherence

EQ14.To what extent are the market surveillance provisions coherent internally?

EQ15.To what extent are the market surveillance provisions above still coherent with other Union legislation on market surveillance on non-food products?

EQ16.To what extent are these provisions coherent with wider EU policy?

EU added value

EQ17.What is the additional value resulting from the market surveillance provisions at EU level, compared to what could be achieved by Member States at national and/or regional levels?

EQ18.To what extent do these provisions support and usefully supplement market surveillance policies pursued by the Member States? Do the provisions allow some sort of 'control' by the EU on the way national authorities carry out market surveillance?

4.Method

4.1.Sources

This evaluation builds partly on an external study carried out by a consultant. The methodology of the study consisted of desk research, field research and case studies. The results of the study and its methodology are set out in Annex 4 which builds on, and analysed Annexes 1 to 3 and 5 to 9 18 .

In addition, this evaluation uses the market surveillance programmes of Member States, the results of the review and the assessment set out in Annex 7, the first report on the implementation of the Regulation 19 , and other documents set out in the Annex of this evaluation, including the evaluation of Union harmonisation legislation 20 .

Yet, it is important to keep in mind the complementary nature of the market surveillance provisions and the fact that Union harmonisation legislation has evolved fundamentally, especially with regard to market surveillance. As mentioned in section 2.1.3 Regulation (EC) No 765/2008 and Decision 768/2008/EC were the starting point for the introduction of specific market surveillance procedures in Union harmonisation legislation. Since their adoption, almost twenty directives and regulations 21 with market surveillance procedures were adopted by the European Parliament and the Council and referring directly to the market surveillance provisions.

Therefore, it is quite difficult to separate the effectiveness, the efficiency, the relevance and the EU added value of, on the one hand, the market surveillance provisions in the Regulation and, on the other, the market surveillance procedures in these directives and regulations. Nonetheless, this evaluation focuses specifically on the market surveillance provisions in the Regulation and will separate them from any other elements set out in other legal instruments. Their coherence will be examined in the section on coherence.

4.2.Limitations – robustness of findings 

The baseline data are quite limited and are hardly comparable with the current data 22 . In addition, Union harmonisation legislation was amended for several products since 2008, which may have an impact on the findings on formal non-compliance since this type of non-compliance was less prominent in the previous legislation. Formal non-compliance also includes, for example, missing warnings and information for consumers on the packaging. Therefore, it could also lead to safety problems.

There were some significant data gaps, especially as regards availability, reliability and structure 23 . Triangulation was used wherever possible 24 . In particular:

(1) Significant gaps in data availability make it difficult to provide a complete picture of the dimension of product non-compliance across the EU. In light of this constraint, it is difficult to draw robust conclusions on the effectiveness of the Regulation in reducing product non-compliance with respect to the years prior to its entry into force. In order to have at least a partial overview of the issue, two solutions have been implemented:

·RAPEX notifications were used as a proxy for measuring product non-compliance, although they only relate to products that pose (serious or “other”) risks to the health of consumers/users and thus represent an underestimation of the real dimension of non-compliance,

·some indicators provided in national reports (number of product-related accidents/user complaints, corrective actions taken by economic operators, inspections resulting in findings of non-compliance, inspections resulting in restrictive measures taken by MSAs) were also be used as proxies for product non-compliance, where information was available 25 .

(2) The analysis of the implementation and the cost-benefits analysis encountered main difficulties due to the differing levels of detail in the information provided by Member States' authorities, as to market surveillance activities carried out and available resources. Information was only partially or not available at all for a large number of countries.

Finally all the steps presented for the market analysis were subject to the following issues: (i) Definitions of sectors/products in the regulation are usually different from nomenclatures used within statistics; (iii) Statistics at the sectorial/product level use different nomenclatures (e.g. intra EU trade uses the Standard International Trade Classification [SITC], production values use the PRODuction COMmunautaire [PRODCOM] nomenclature, business demographics uses the Statistical Classification of Economic Activities in the European Community [NACE]); (iii) Difficulties in identifying harmonised sectors in case EU legislation introduced harmonised rules that apply only to some products within sectors. As a result, the outcomes of this analysis are to be regarded as indicative estimates.

5.Implementation state of play (Results)

5.1.Market surveillance structures and measures 

According to Article 16(1) of the Regulation, “Member States shall organise and carry out market surveillance as provided for in this Chapter [i.e. on General requirements]”. The Regulation does not set out explicit obligations as to how market surveillance shall be organised at the national level, this being left to Member States’ prerogative. Therefore, market surveillance is organised differently at the national level in terms of the sharing of competences and powers between Market surveillance authorities 26 . In this regard, three types of overall organisation models have been implemented by Member States, although with a number of additional country-specific nuances: 27

Centralised, where activities are carried out by one or few Market surveillance authorities. This model is applied in Bulgaria, the Czech Republic, Luxembourg, Malta, Portugal, and Slovakia.

Decentralised at the sectoral level, where several Market surveillance authorities operate and have different competences, depending on the sector where they perform market surveillance activities. This model is adopted in Belgium, Cyprus, Croatia, Denmark, Estonia, France, Greece, Ireland, Italy, Latvia, Lithuania, Poland, the Netherlands, Romania, Slovenia and Sweden.

Decentralised at the regional/local level, where numerous Market surveillance authorities have enforcement responsibilities on specific geographical areas of competence. Austria, Finland, Germany, Hungary, Spain and the United Kingdom follow this organisational structure.

The following boxes provide an overview of the organisation models implemented respectively by Italy and Germany.

Box 1: The Italian organisational model of market surveillance

The Italian model of market surveillance is decentralised at the sectoral level. The Ministry of Economic Development (MISE) is the main national MSA and acts as a coordination body for the different enforcement authorities conducting market surveillance in the field, for relations and negotiations at the EU level, for the use of Rapid Exchange of Information System (RAPEX) and Information and Communication System for Market Surveillance (ICSMS), and for the establishment of ad hoc budgets and objectives. The MISE has general responsibilities over all sectors covered by Regulation 765/2008. Different ministries are in charge of market surveillance in various sectors within the scope of the Regulation. For instance, the Ministry of the Interior is responsible for market surveillance of explosives, while chemicals fall under the responsibility of the Ministry of Health. The Ministry of Infrastructure and Transportation controls the largest number of product categories. Each ministry organises its own market surveillance enforcement system.

Other relevant enforcement bodies are:

·The Institute for Environmental Protection and Research – ISPRA, under the Ministry of the Environment, which is in charge of enforcing Regulation 765/2008 regarding noise emissions for outdoor equipment. 28

·The Italian Economic and Financial Police – Guardia di Finanza (GdF), under the Ministry of Economy and Finance. Market surveillance activities are undertaken by the Special Unit for the Protection of Markets which exercises its powers on toys, personal protective equipment, low-voltage electronics and electromagnetic compatibility. The Guardia di Finanza operates autonomously within the territory or in collaboration with the Customs Authority. It can also file RAPEX notifications.

·The Chamber of Commerce, coordinated by Unioncamere that report to the Ministry of Economic Development. Their activities are based on annual bilateral agreements, establishing the number and the sectors of the planned inspections. Inspected sectors vary from year to year and can include toys, textile and footwear labelling, as well as electrical equipment.

·The Local Health Units (Azienda Sanitaria Locale, ASL), under the Ministry of Health. They carry out health and safety inspections in the workplace. Although their core mission is not primarily related to market surveillance, they can sometimes find evidence of non-compliance in plants, machinery, medical devices or personal protective equipment during their inspections.

·The special unit of the Italian Police Carabinieri, NAS. It is a law enforcement body under the Ministry of Health, focused on health and safety controls covering several product categories. In particular, this unit of the Carabinieri monitors activities under the General Product Safety Directives (GPSD), toys, medical devices, plant protection products, as well as health products – all within the scope of the Regulation 765/2008.

The National Customs Authority is responsible for product checks at the border and it is mainly active near airports and harbours through its local offices.

The analysis of the Italian system has identified certain strengths and weaknesses of this model of organisation. First of all, while it is organised in a pyramidal way, with the MISE as the main body responsible for national market surveillance and in charge of coordination. Overall, however, it seems that there are no formal channels or established standard procedures through which the different ministries can coordinate their activities. As a consequence, although the MISE may have the formal powers over MSAs’ activities, in practice it has no power of control over their budgets and therefore on priority setting. Indeed, it seems that market surveillance, in the context of Regulation 765/2008, is just one of the many tasks that each enforcement body has to deal with on a daily basis. Second, sectoral decentralisation has led to different product sectors being under the responsibility of the most appropriate ministry or institution, thus providing a higher level of specific knowledge. However, this adds complexity to the management and uniformity of market surveillance at the national level. In particular, the fact that every ministry internally organises its own market surveillance structure for each product category leads to variation in the ways the different sectors are controlled and managed. Moreover, fragmentation throughout the territory may hinder authorities’ response times. In this context, an overlap of competences may also happen. A critical operational issue is the integration of Regulation 765/2008 with other sectoral legislation, given that the primary responsibility for the enforcement of the Regulation is under the MISE, while the enforcement of some sectoral laws is under the responsibility of the relevant ministries. Moreover, some sectors can be controlled by multiple authorities, as in the case of GPSD. Therefore, there may be cases where products need multiple evaluations and validations in order to be allowed to enter the market.

Box 2: The German organisational model of market surveillance

Germany is characterised by a structure decentralised at the regional/local level, where competences are shared among various Land authorities. Germany is a Federal Republic made up of 16 Länder whose ministries are separate from the Federal Government, both from a policy and financial point of view. The Federal Government and Federal Ministries are responsible for the overall legislation (laws and regulations), while the 16 Länder are in charge of the enforcement of this legislation. Resources for market surveillance are therefore provided by the Länder themselves.

The 16 Länder coordinate their enforcement action through several committees, where representatives from the Land ministries and MSAs regularly meet. Committees are focused on selected sectors. The biggest committee is the Working Committee on Market Surveillance – AAMÜ, which covers the largest number of sectors within the scope of Regulation 765/2008. 29 Another coordination body is the Central Authority of the Länder for Technical Safety (ZLS). The ZLS was set up to centralise some market surveillance tasks, such as the creation of product risk profiles and the forwarding of RAPEX notifications, instead of having them repeated for all of the 16 Länder. The ZLS has more operational tasks than the other coordination committees and can even enforce the law under special conditions and following the Länder’s requests (for instance, when a market surveillance case involves several Länder or has international relevance). Another pillar of the German coordination strategy is represented by the extensive use of ICSMS, which national authorities are very familiar with, as it was first developed in Germany. As already mentioned, ICSMS is crucial to avoiding duplication of work, a possible deficiency of decentralised structures.

At the central level, three Federal MSAs enforce market surveillance in specific product sectors:

·The Federal Network Agency – BNetzA, under the Federal Ministry of Economy and Energy, is responsible for market surveillance in two sectors: electrical equipment under the Electro-Magnetic Compatibility Directive 30 and radio and telecommunications equipment under the Radio and Telecommunication Terminal Equipment Directive; 31  

·The Federal Authority for Maritime Equipment and Hydrography – BSH, under the Federal Ministry of Transport and Digital Infrastructure, is responsible for the marine equipment sector;

·The Federal Motor Transport Authority – KBA, under the Federal Ministry of Transport and Digital Infrastructure, is responsible for motor vehicles.

Three additional Federal agencies are also involved in the context of market surveillance, though they are not responsible for enforcement in individual product sectors, the Federal Institute for Occupational Safety and Health – BAuA, 32 the Federal Institute for Materials Research and Testing – BAM, 33 and the Federal Agency for Environment – UBA. 34

The Central Customs Authority (Generalzolldirektion) is responsible for many fields other than those related to the Regulation (e.g. drugs, weapons, human health, and environment). It also coordinates, manages and supervises the 270 local Customs offices, which are in charge of border controls.

The analysis of the German system has identified certain strengths and weaknesses of this model of organisation. A clear strength of the system is that the German organisational structure establishes a responsible authority for each product sector where tasks are well defined and competences clearly split. Therefore no overlapping occurs between the Federal and the Land level in terms of market surveillance responsibilities in all sectors covered by the Regulation. Nonetheless, substantial resources are required to replicate a market surveillance system in 16 Länder. Furthermore, particularly in the case of Customs, the high number of organisational entities involved in the organisation of market surveillance makes difficult to identify the ‘right partner’ to deal with market surveillance issues. Even more importantly this organisational model has required many efforts to ensure the necessary level of coordination (e.g. the establishment of permanent, ad hoc coordination bodies such as the ZLS, the organisation of workshops, meetings and events to create an ‘informal’ network of market surveillance actors). The efficiency of the several coordination tools seems also to be an issue. Germany is indeed planning to create a single, general coordination board covering all product categories and ensuring further alignment between the Federal, the Land and the European level that would rationalise the existing coordination mechanisms.

Section 5.2 of Annex 4 and section 2 of Annex 7 provide a detailed country-by-country overview of the current situation in terms of structures relevant to the implementation of the market surveillance provisions with regards to the organisation of market surveillance at the national level, the market surveillance activities to detect non-compliant products, the existing coordination and cooperation mechanisms within/among Member States, and the measures taken against non-compliant products.



Figure 2: The Italian organisational model of market surveillance

Figure 3: The German organisational model of market surveillance

5.2.Additional information

5.2.1.Exchange of information (ICSMS, notifications of restrictive measures, national market surveillance programmes and reports on activities)

The market surveillance provisions in the Regulation foresee instruments for the exchange of information between Member States 35 . They include RAPEX 36 and ICSMS 37 as key tools for the cross-border exchange of information and work sharing between market surveillance authorities.

While RAPEX is successfully used for dangerous consumer products posing a risk to the health and safety in the context of the GPSD 38 , it is much less used for the other serious risks covered by Article 20 of Regulation (EC) No 765/2008:

Table 4: RAPEX notifications under Regulation (EC) No 765/2008

Year

Professional Products

Electromagnetic disturbance

Incorrect measurement

Environmental risk

2012

31

0

0

4

2013

53

8

1

63

2014

32

1

0

32

2015

24

1

0

35

2016

47

0

0

41

Total

187

10

1

175

Almost all Member States now use ICSMS, after a slow take-up 39 . More than 7,000 products are encoded in the system every year. In 2015 the database contained information on around 70,000 products and more than 250,000 files stored (i.e.: test lab reports, declarations of conformity, pictures, etc.). However, Member States use the system to different degrees, as illustrated in the diagram below which shows the numbers of product information put into the ICSMS system during 2016. Clearly the system is not used very well by many market surveillance authorities and some are not using the system at all. Even within Member States, such as the UK and Germany, there is a great variation between different market surveillance authorities on their use of the system.

Figure 4: Use of ICSMS by all EU/EEA Member States in 2016 40 :

Figure 5: Use of ICSMS by EU/EEA Member States excluding Germany in 2016:

In addition to this, it is worth mentioning that sector specific Union legislation also sets out an obligation for Member States' competent authorities to communicate to the other Member States restrictive measures taken against non-compliant products. This procedure is often referred to as the 'safeguard clause procedure'. Furthermore, receiving Member States then have an obligation to 'follow up' on those notifications, i.e. adopt in turn appropriate measures in respect of their national territory. In many cases they also have the possibility to object to the measures notified and in this case the Commission will assess whether it was justified 41 . Recent guidance discussed at expert's working group level clarifies principles for cooperation based on the existing legal framework and the link between these obligations and the use of the RAPEX and ICSMS tools 42 . However, with the exception of few sectors (notably low voltage equipment) only few notifications of restrictive measures are actually officially sent by national market surveillance authorities. Furthermore, even in these 'best case scenarios' sectors many Member States do not actually notify any measures and the number of notifications is decreasing overtime 43 .

The market surveillance provisions in the Regulation require Member States to draw market surveillance programmes and to periodically review and assess the functioning of their activities at least every four years (Articles 18(5) and 18(6)). All Member States communicated market surveillance national programmes and reports to review and assessed the functioning of market surveillance activities during the first four years of application of the Regulation 44 . However, since the Regulation does not provide any details on the content of the programmes and reports, the sectorial coverage and the quality of information contained in this documentation varies remarkably from Member States to Member State 45 . Comparability of information is also an issue.

5.2.2.Cooperation

Since 2013, on the basis of the Regulation financing provisions, the European Commission provides logistical and financial support for informal cooperation between national authorities that takes place by means of the so-called Administrative Cooperation groups (hereinafter 'AdCos') 46 in a number of sectors. AdCos participants discuss several issues related to the market surveillance, elaborate common guidance documents and sometimes carry out joint enforcement actions. According to the feedback received from AdCos this support has proven beneficial in increasing and stabilising the rate of participation of national authorities in the meetings.

Table 5: Participation in AdCo meetings

AdCo 47

2014

2015

2016 (1st semester)

Partici-pants

Represented countries

Partici-pants

Represented countries

Partici-pants

Represented countries

MSs

Other

Total

MSs

Other

Total

MSs

Other

Total

ATEX

35

15

3

18

33

17

3

20

33

21

2

23

33

17

3

20

33

17

2

19

33

14

2

16

CABLE

23

12

3

15

21

10

2

12

26

12

3

15

CIVEX

no data for 2014

30

20

1

21

October/November

COEN

no data for 2014

no data for 2015

no data for 2016

CPR

31

20

2

22

43

21

4

25

36

15

4

19

46

23

3

26

44

25

2

27

EMC

38

20

4

24

37

21

5

26

40

18

4

27

36

19

4

23

34

22

4

26

ENERLAB / ECOD

no data for 2014

32

22

1

23

43

21

1

22

34

18

3

21

GAD

18

14

0

14

15

8

2

10

19

12

2

14

14

11

0

11

16

11

2

13

LIFT

25

12

3

15

24

14

3

17

25

17

2

19

21

14

2

16

LVD

31

15

4

19

32

20

4

24

36

17

4

21

33

19

3

22

34

22

3

25

31

18

4

22

MACHINE

32

17

3

20

33

20

3

23

38

20

4

24

33

15

3

18

30

19

3

22

NOISE

22

10

2

12

23

9

2

11

Meeting October 2016

PED/SVPD

22

13

3

16

25

15

4

19

24

15

4

19

25

18

3

21

15

11

1

12

PPE

44

21

4

25

39

19

4

23

39

20

5

25

37

19

4

23

40

21

4

25

PYROTEC

30

14

0

14

34

17

0

17

32

19

1

20

30

15

0

15

34

19

0

19

RCD

35

17

2

19

22

15

2

17

31

19

2

21

33

16

3

19

30

19

1

20

RED

23

12

2

14

41

25

4

28

41

23

2

25

40

24

2

26

41

22

4

26

40

25

2

27

39

19

4

23

44

22

3

25

TOYS

no data for 2014

37

18

5

23

32

15

4

19

40

25

3

28

TPED

12

9

0

9

23

12

1

13

21

8

3

11

13

5

1

6

WELMEC

no data for 2014

31

21

1

22

33

19

4

23

36

19

4

23

As regards the development of common market surveillance projects, the following table summarises the joint actions carried out or launched within different AdCos during the 2013-2016 period and number of countries participating in the action:

Table 6: Joint actions organised within AdCos and number of Member States (MS) participating 48

AdCo

2013

2014

2015

2016

ATEX

CABLE

CIVEX

COEN

Information and instructions on reprocessable products (12 MS)

Clinical data (7-8)

Harmonising inspections (7-8 MS)

CPR

2012-2013: EPS (10 MS)

Smoke alarms (10 MS)

Windows (7 MS)

ECOD / ENERLAB / ROHS

ECOD: Lighting and chain lighting (10 MS)

ROHS: Toys (8 MS) and Kitchen appliances (10 MS)

ROHS: Cheap products (10 MS)

ROHS: Cables/USB/others (6 MS)

ECOD: Defeat devices (4 MS)

ENERLAB: Collecting inspection data methodologies (6 MS)

EMC

Switching power supplies (19 MS)

Solar inverters (14 MS)

GAD

Gas appliances (8 MS)

LIFT

LVD

LED

Floodlights* (13 MS)

MACHINE 49

2012-2013: Log Splitters (about 8 MS)    

    2012-2015: Firewood Processors (about 7-8 MS)    

(1)    2011-2015: Impact Post Drivers (3-4 MS)

        

Boom saws (3 MS)

Portable chain-saws and vehicle servicing lifts* (9-10 MS)

NOISE

PED

Air receivers for compressors (2 MS)

PPE

PYROTEC

REACH

1 big action/year involving all Member States. Additional pilot actions on a smaller scale

RED

Mobile phone repeaters (14 MS)

Drones (18 MS)

RCD

Small inflatable crafts (6 MS)

TOYS

TPED

WELMEC WG5

Electric energy meters* (11)

Heat meters* (10)

* project co-financed by the European Commission.

Some joint market surveillance campaigns were financed by the European Commission on the basis of financing provisions included in the market surveillance provisions. In particular, the following calls for proposals were issued since 2013:

·In 2013 the Commission launched the first call for proposals for joint enforcement actions under the multi-annual plan for market surveillance of products in the EU. The grant was awarded to a project focussed specifically on active electrical energy meters and heat meters. The grant took the form of a 70% reimbursement by the Commission of the eligible costs of the action (amount approximately allocated 350 000 EUR) and was fully managed by Member States. The action was carried out by a consortium of authorities under the coordination of a Spanish authority.

·In 2014 a new call for proposals for joint enforcement actions was launched and led to funding by the Commission of two proposed actions respectively in the field of machinery safety and LED floodlights. The grants that have been awarded are in the form of an 80% reimbursement by the Commission of the eligible costs of the actions (total amount allocated is approximately 1000 000 EUR). One of the actions was coordinated by a Finnish authority, while the other was coordinated by the "Prosafe" foundation 50 .

·In July 2015 a call for proposals was launched with a maximum budget foreseen for EU financing of 500 000 EUR. One proposal was received by the deadline of 1 October 2015 but did not lead to the award of any grant since the proposal received did not address the objectives as stipulated in the call.

·In March 2016 two calls for proposals were launched with a higher maximum budget foreseen for EU financing of 750 000 EUR and 540 000 EUR respectively, but no proposals were received.

5.2.3.Infringement proceedings 

The Commission did not launch any infringement proceedings related to the market surveillance provisions. There have been two complaints from economic operators but both cases were closed in the absence of a clear breach of the Regulation.

It is unclear whether the limited number of complaints is due, either to the clarity of the provisions, or to the fact that the market surveillance provisions are not very known with businesses. The fact that these provisions only set minimum requirements for market surveillance leaving Member States with high discretion in their implementation, and the relative uncertainty on the precise scope of the Regulation may also have had an impact.

Furthermore, there were no judgements from the Court of Justice about the provisions.

6.Answers to the evaluation questions

6.1.Effectiveness

EQ1 -    Are the results in line with what is foreseen in the impact assessment for the Regulation, notably with regards to the specific objectives of (i) enhanced cooperation among Member States, (ii) uniform and sufficiently rigorous level of market surveillance, (iii) border controls of imported products?

6.1.1.Enhanced cooperation among Member States

The impact assessment for the Regulation foresaw that cooperation and information exchanged would be considerably improved under the preferred option. The market surveillance provisions have indeed improved substantially the cooperation between Member States which nevertheless often remains difficult due to the high degree of fragmentation in market surveillance competences and the slow take up of the different tools to share information and coordinate enforcement work 51 .

6.1.1.1.Exchange of information (ICSMS, notifications of restrictive measures, national market surveillance programmes and reports on activities)

Statistics presented in section 5 and information gathered from stakeholders show that the use of ICSMS by Market surveillance authorities is still limited, or that some Member States do not even use ICSMS at all. Even within Member States there is a great variation between Market surveillance authorities in their use of the system. This hampers the possibility of capitalising the work carried out by other authorities and creates a duplication of effort, which is the case when the system is properly used, as shown by the German practice analysed in case study 2. Also, the possibility for Market surveillance authorities and Customs to make use of test reports drafted by Market surveillance authorities in other EU countries seems to be limited 52 . On the other hand a number of Market surveillance authorities pointed out the burden due to the filling-in of both ICSMS and internal/national databases because of compatibility issues.. Further frequent issues concern the lack of adaptations to insert sector-specific information into ICSMS and there being no opportunity to update information along the progress of the case. The low user-friendliness to ease data entry, difficulties in finding instructions on how to use ICSMS and linguistic barriers are also reported as minor issues that could be improved 53 .

As for RAPEX, its use has significantly increased over the years, both in terms of the number of notifications and follow-up actions. Moreover, the number of follow-ups outweighed the number of total notifications from 2014, this possibly indicating that RAPEX is more and more recognised and used as an information tool for enforcing market surveillance. However, the use of RAPEX across Member States differs, indicating that some Member States are more proactive while others are more reactive in dealing with notifications. Yet, there are doubts on the full use of RAPEX considering that the number of notifications made in the system is not proportionate to the size of the national markets.  54 For instance, Cyprus notifies on average more than Poland, Sweden and Romania. An obstacle to the use of RAPEX is the perceived redundancy of having different notification procedures and communication tools: some market surveillance authorities think that ICSMS, RAPEX and the safeguard clause should be integrated within a single information system to avoid double encoding of information and inconsistencies 55 . On the other hand, as mentioned in section 5 the safeguard clause procedure set out in sector specific Union legislation appears largely underexploited by Member States 56 .

The market surveillance programmes are considered potentially very useful by stakeholders because they are an opportunity to define market surveillance strategies and to inform consumers. The programmes are also useful to avoid overlapping of market surveillance actions, working as a tool for cooperation between market surveillance authorities. They can even contribute to ensuring a level playing field in Europe, since they allow Member States to acknowledge the differences in the enforcement actions and possibly to eliminate them 57 . The national 'review and assessment' reports can importantly contribute to improving the effectiveness and efficiency of market surveillance activities since they help in verifying and monitoring implemented activities.

However, the requirements of the provision on these programmes and reports are rather general, and this has led to the development of different practices in the preparation of these documents and hindered the provision of relevant information. Several efforts were made at experts' level to build common templates and procedures to capitalise the tools, which led to increasing uniformity in the content of the programmes 58 . Nevertheless, information contained therein is often too generic to serve as a planning tool. Furthermore, many programmes are shared by Member States too late (i.e. months after the start of the period they refer to) to be able to learn from each other’s experience and enhancing collaboration 59 . As regards national reports, important information gaps and issues of comparability of data limit the possibility to have a complete overview of market surveillance activities in the internal market.

6.1.1.2.Cooperation

The sub-optimal use of information systems to exchange information hampers also cooperation between Member States - that is mainly based on the use of those systems and on European-level initiatives (namely ability to respond and/or complement each other enforcement action, cooperation through AdCos, and joint actions) 60 .

Besides the sub-optimal use of information systems, cooperation between Member States faces additional challenges. Even if the majority (77%) of Market surveillance authorities and Customs consulted state that they cooperate with authorities based in other Member States and the large majority of Market surveillance authorities declare that they notify other Member States (75%), most of the Market surveillance authorities (78%) rarely restrict the marketing of a product following the exchange of information on measures adopted by another EU MSA against the same product.

The respondents to the Public Consultation 61 indicate that market surveillance authorities rarely restrict the marketing of a product following the exchange of information about measures adopted by another market surveillance authority in the EU against the same product. This occurs “sometimes” according to 34% of stakeholders and "never " according to 8% of respondents, while a minority declare that it occurs “very often” (12%) or “always” (6%). Cross-border cooperation remains problematic, according to the respondents 62 .

According to informal feedback from national experts, requests for mutual assistance among authorities in different Member States to supply each other with information or documentation and to carry out appropriate investigations are made and followed up only occasionally.

Furthermore, a closer look at ICSMS shows that, more than 80% of the cases transferred from one market surveillance authority to another ('baton passing') through the system are done within the same country. In addition, many of the cases that one market surveillance authority wishes to transfer to its colleagues in another Member State are rejected. The main reason for many rejections is that the 'target authority' considers itself as geographically or materially not competent to handle the case; a lack of resources was also frequently argued.

Figure 6: Baton passing in ICSMS among Member States (status December 2016):

Figure 7: Rejections of baton passing in ICSMS (December 2016):

Figure 8: Baton passing initiated in ICSMS (December 2016):

6.1.1.3.AdCos

Authorities contacted through targeted interviews confirmed that participating in AdCos work proves to be essential for coordinating actions and keeping an eye on what Market surveillance authorities in other Member States do, as well as learning from each other. Furthermore, the number of AdCo groups has increased with respect to the period previous to the implementation of the Regulation, rising from “more than ten” to the current twenty-five This could possibly indicate an incentive to cooperate on sectoral market surveillance issues due to the introduction of the Regulation.

However, not all Market surveillance authorities participate in this form of administrative cooperation. Figures presented in section 5 show that during the 2014-2016 period for most AdCos (ATEX, CPR, EMC, LVD, MACHINE, PPE, PYROTECH, RCD, TOYS, WELMEC) about two thirds of Member States did take part in meetings (with a peak of 80% participation rate for the radio equipment group); however in others (GAD, LIFT, PED) only about 50% Member States participated in the meetings and in the case of CABLE, NOISE and TPED only about 30-40% of Member States were involved. Furthermore, according to the feedback received from AdCo Chairs, many Member States representatives participating in the meetings do not get actively involved in common discussions and activities. In light of this, the Commission has increased its support for these groups, underlining that the chairpersons bear a remarkable burden when organising meetings and that many Market surveillance authorities cannot attend due to budgetary constraints.

6.1.1.4. EU financing

The overview provided in section 5 on EU financing made available on the basis of Regulation (EC) No 765/2008 shows that the initial calls for proposals launched by the Commission were very successful but the following calls were not. The reason for the limited use of EU financing of cooperation activities seems to be related to the complexity of administrative processes, both at the EU level as within the authorities who are also subject to national administrative rules. Notwithstanding simplifications in the grant management rules for EU co-funded projects and increased co-funding rates, market surveillance authorities have difficulties to take-up funding made available at EU level in the form of project grants 63 . For each project a new partnership between different Member State authorities has to be constituted. The management of a project places a considerable burden on the lead authority expected to coordinate work with partners in other Member State authorities and to make financial commitments on their behalf. Member States complain about the lack of an administrative framework for the management of these actions and of the available money 64 .

6.1.1.5.Provisional conclusion

Coordination and cooperation mechanisms are significantly developed, consisting of an impressive number of initiatives, and all stakeholders recognise them as useful. However, they have not reached a level that can be considered satisfactory, especially considering those existing among Member States. In particular, despite the fact that necessary tools are in place to ensure cross-border market surveillance cooperation, they are not used to an extent sufficient to trigger effective coordination and efficient work sharing among surveillance authorities in the Single Market. There is still a need for higher level exchange of information, follow-up to enforcement carried out by other authorities and joint surveillance actions 65 .

6.1.2.Uniform and sufficiently rigorous level of market surveillance 

The 2007 impact assessment of the Regulation was not very explicit on this point but foresaw that the preferred option would allow a more effective and efficient market surveillance. Furthermore, the relevant provisions in the Regulation are drafted in such general terms that it is impossible to measure precisely the progress that was made since 2010. For example, the market surveillance provisions oblige Member States to 'entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks' while market surveillance authorities must 'perform appropriate checks on the characteristics of products on an adequate scale'.

Nonetheless, a satisfactory level of uniformity and rigorousness of market surveillance has not been achieved yet. As regards the organisation of market surveillance at national level, Member States have implemented the Regulation in many different, specific forms, in terms of distribution of competences 66 and internal coordination mechanisms, level of deployed resources (financial, human and technical), market surveillance strategies and approaches, powers of inspection and sanctions and penalties for product non-compliance. Apparently, there is no provision of the Regulation that has been implemented identically in at least two Member States.

6.1.2.1. Organisational model, resources, strategic approach to market surveillance, monitoring systems

Firstly, the organisation of market surveillance is different across Member States, not only in terms of the level of centralisation of the organisational model (see section 5), but also in terms of available resources (financial, human, and technical). The amount of resources made available cast some doubts on the ability of market surveillance authorities to 'perform appropriate checks on the characteristics of products on an adequate scale'.

Significant differences exist across countries regarding the availability of resources and numbers of inspections performed by the EU Member States in order to accomplish the tasks set out in the Regulation.

·Available figures show that resources allocated to market surveillance amount on average to a few euros per thousand inhabitants (with the exception in particular of medical devices, cosmetics and toys) and from 0 to maximum 0.5 inspectors per million inhabitants 67 .

·The total budget available to all Member States' authorities having reported the information, in nominal terms 68 decreased during 2010-2013 period (from €133.4m to €123.8m); also it is concentrated in a limited number of countries and large differences could be noted in terms of budget available to each country during the four year-period 69 .

·A similar trend was noted for human resources: over the period 2010-2013, a reduction of staff available to MSAs can be observed together with a concentration of staff in a small number of Member States 70 . Furthermore, at least 12 Member States complain about the resources being limited 71 .

Figure 9: Contribution of each MS to the total budget available in nominal terms to MSA at EU level over 2010-2013 72

Figure 10: Annual budget available to MSAs in nominal terms, average 2010-2013, € M 73

Figure 11: Total budget available to 19 MSAs in nominal terms during 2010-2013, € M

 

Figure 12: Total staff resources available to MSAs (FTE units) during 2010-2013 74

Furthermore, the availabilities of laboratories for product testing widely very across Member States, though a widespread lack of testing capacity can be identified 75 .

Figure 13: Market surveillance authorities’ availability of in-house laboratories for product testing in 33 sectors covered by the Regulation 76

The availability of resources seems to influence the depth of market surveillance controls. Some Member States perform a lot more physical checks of product than testing, and also have few in-house laboratories. Other Member States give higher importance to administrative aspects than to technical aspects, when checking compliance. Therefore, the intensity of enforcement activities varies across countries.

Figure 14: Share of physical checks and of laboratory tests performed on total inspections, average 2010-2013 77

A further element of differentiation is represented by Market surveillance authorities’ strategies of market surveillance.

Figure 15: Average of reactive vs proactive Market surveillance authorities’ inspections between 2010 and 2013 78

In order to assess to what extent market surveillance activities are proportionate to the dimension of the national market, the total number of inspections carried out by Market surveillance authorities has been compared respectively to the number of inhabitants and to the number of enterprises active in the harmonised sectors per Member State. It is stressed that both indicators represent imperfect proxies for the size of national markets and the results of the comparisons should be interpreted carefully:

·The first analysis suggests that in many sectors and many Member States the number of inspections is rather low in comparison with total population 79 . Figures for the number of laboratory tests are much smaller, confirming that the large majority of inspections focused mainly on documentary and possibly visual checks of conformity. It is also noted that information provided by Member States on inspections carried out often only covers a subset of sectors where market surveillance should take place. 80 In some cases these information gaps may be interpreted as an indication of the lack of market surveillance activities.

·The second analysis shows that the average correlation between the number of inspections and the number of enterprises per Member State– though positive - is very low (i.e. 0.15), therefore suggesting that Market surveillance authorities’ activities and efforts are not related to market dimensions 81 . However the interpretation of the actual values per Member State cannot be pushed further due to several shortcomings of this proxy 82 .  

Finally, heterogeneity exists in the system of monitoring and reporting set up by the Regulation, i.e. the national reports. As discussed, the Regulation aims to create a framework for market surveillance controls and sets up a monitoring system (through Article 18(6)) to supervise how and to what extent these controls are performed. However, national reports are not uniform or comparable across Member States, and present a significant number of gaps and inconsistencies. These issues reflect the existing differences in the organisation models – which make it for instance difficult to collect and/or aggregate data on market surveillance activities – but also differences in market surveillance approaches – e.g. the different interpretations of what an inspection is.

6.1.2.2.Powers of national authorities

Differentiation has been assessed also in terms of powers of inspection, which are differently attributed to national Market surveillance authorities (and across Market surveillance authorities within the same Member State) as they are established by different national legislative frameworks. Whereas core powers such as performing documentary and visual checks, physical checks on products, inspection of business’s premises, and product testing, are common to most Member States, additional powers can be granted to Market surveillance authorities depending on the Member State and the sector considered, which makes the approach to inspections heterogeneous across Member States and sectors. The same picture applies to Customs that can have different powers depending on the Member State considered. For instance, the power to destroy products and to recover from economic operators the related costs is granted to Customs in some countries, but not all 83 .

The following figure displays the extent of the inspection powers in a sample of Member States for which relevant information was available.

Figure 16: Extent of inspection powers in 17 EU Member States, considering 33 sectors covered by the Regulation 84

Differences in the allocation of powers are evident also when looking at powers related to online trade, which as the following box shows, represent a specific issue where a more uniform market surveillance approach would be required across Member States.

Box 3 – Market surveillance of online sales 85

Online sales have become an important issue for market surveillance. The analysis undertaken highlights the following specificities as relevant to understand the challenges market surveillance faces in the case of online sales:

·Online sales are characterised by a high number of small consignments, with goods most of the time directly delivered to consumers;

·The number of existing web shops is huge;

·Even though a web shop is shut down, it is very easy to create a new web shop changing the name and the domain in a short time; as a result, unsafe products withdrawn/banned from the EU market can return on the market through a different website or under a different legal name;

·In many cases, the number of parties and intermediaries determine a complex distribution chain, where especially the role of fulfilment houses 86 and commercial platforms is not clear;

·Economic operators are often located in third countries and Authorities are not informed in advance that products are being imported;

·Online channels can be used to make unsafe, withdrawn products return on the market;

·Consumers are not fully aware of the risks associated with buying products online.

Vis-à-vis these specificities, the majority of stakeholders face specific issues related to online sales and current market surveillance does not seem to be fully effective to online sales for various reasons.

First, specific powers of inspections and sanctioning related to online sales are present only in few Member States: most Market surveillance authorities do not have enough power to deal with products sold online and powers of sanction are generally not extended to those kinds of product.

Second, irrespective of the existence of explicit powers, bodies, or procedures for online sales, enforcement activities are not straightforward: market surveillance on products sold online is particularly challenging for most Member States, due to both the high volumes of products and websites involved (that would require resources that are not available), and the difficulties in inspecting and sanctioning the responsible economic operator given the complex (and sometimes invisible) distribution chain, with products most of time directly delivered to consumers.

Third, in some cases, in light of the already mentioned complex distribution chain, the same identification of the responsible economic operator is challenging, and even when authorities have the power to shut down websites, this might take several months and the action is ineffective since, as described above, sellers can change name and domain in a short time.    

Difficulties are exacerbated in the case of cross-border online sales, where action –that should be particularly fast- is lengthy and costly due to jurisdictional constraints and becomes basically irrelevant when third countries are involved. Indeed, tackling websites outside of the EU is very difficult: communication and response by economic operators even when clearly identified are very limited, and cooperation with Authorities from different countries is not always fast and effective. Moreover, border controls of goods sold online are particularly difficult since there is no previous information about shipments, Authorities are not informed in advance that products are being imported, and often there are no electronic declarations.

Despite some Member States having tailored strategies to tackle online sold products, the current market surveillance approach to online sales is still conducted in a fragmented and uncoordinated way.

As a result, non-compliance of products sold online is a real issue, especially when e-commerce popularity has increased amongst consumers and when 78% of participants to the targeted survey reported that there are non-compliance issues related to online trade. Controls effectively performed are considerably less than those that are necessary. As a consequence, also the incentive for economic operators to be compliant is low, considering the low risk of being caught and effectively punished.

In light of this, the current level of protection and legal support to consumers is lower if compared to that for products marketed through other distribution channels. 

Similarly, the sanctioning powers in 17 EU Member States, considering the 33 sectors covered by the Regulation examined in national reports are widely distributed across sectors and Member States.

Figure 17: Extent of sanctioning powers in 17 EU Member States, considering 33 sectors covered by the Regulation 87

These differences highlight that while some powers of inspection and powers of sanctions are uniformly attributed across Member States, others are not, with considerable differences that lead to different models of enforcement power across the EU.

Finally, a high level of heterogeneity can also be traced in the level of sanctions and related procedures. The mapping performed shows that the level of penalties differs both among Member States and across sectors. Similarly, procedures for imposing sanctions differ. In some Member States, Market surveillance authorities can directly impose administrative monetary sanctions together with restrictive measures. In other Member States instead, Market surveillance authorities are obliged to recur to Courts even to impose administrative monetary sanctions. As result of these differences, the current system of penalties and sanctioning powers does not provide sufficient deterrence.

The lack of uniformity in authorities' powers and national procedures can also explain the difficulty of market surveillance experts to endorse the common lines discussed in the context of administrative cooperation because ultimately those are not binding within their national administrations and vis-à-vis national courts. This contributes to explaining the lack of European perspective in the organization of national surveillance. 88  

6.1.2.3.Provisional conclusion

The heterogeneity existing across Member States in the implementation of the Regulation allows the conclusion to be drawn that the level of market surveillance is certainly not uniform, given that Member States with more resources and powers have - at least - more tools for proper enforcement.

This lack of uniformity allows market surveillance to be more rigorous in some Member States than in others. Potential effects are a less effective deterrence power and an unequal level playing field among businesses in some Member States, this also potentially generating an unbalance in the level of product safety across Europe.

As for the general rigorousness of market surveillance in the Single market, the serious lack of data and inhomogeneity of national reports do not allow for a thorough assessment. However, the analysis of information available on the amount of resources attributed to market surveillance and activities reported cast some doubts on the ability of market surveillance authorities to perform checks at an adequate scale. Lack of relevant information may in some cases be an indication of actual enforcement gaps. Furthermore the low usability of data available in national reports is already a finding itself of a drawback of the Regulation in the achievement of its objectives, inasmuch as the major evidence on its functioning (i.e. the effectiveness of market surveillance controls) is so fragmented to render difficult its analysis. The insufficient rigorousness of market surveillance is also supported by the stakeholders’ perception about the incapacity of the Regulation to deter rogue traders, 89  and the discrepancies in the penalty framework.

6.1.3.Border controls of imported products

Although stakeholders indicate that powers attributed by the Regulation to Customs are adequate and the procedures for the control of products entering the EU market foreseen by Articles 27 to 29 of the Regulation are clear, easy to apply, and still relevant, checks of imported products seem to be insufficient. Border control is indeed one of the most challenging tasks for market surveillance nowadays, in light of the increasing importance of EU trade with third countries.

Imports of harmonised goods from third countries represent a large and increasing share of products supplied on the EU market, as it went up from 24% in 2008 to over 30% in 2015. In 2015 they were estimated to value almost 750 € billion. Many respondents to the public consultation found it difficult to indicate the proportion of products imported from third countries in their sector 90 ; however the general perception among stakeholders is that imports are affected by non-compliance 91 . The analysis of Rapex notifications supports the findings that the non-compliance of imports from extra EU is a relevant issue: from 2010 to 2016 notifications concerning imported products were around 75% of yearly published notifications and the percentage remained overall stable over the period. On average, 59% of total yearly notifications concern products from China.

However, it is often difficult to trace and intercept non-compliant products imported from outside the EU and entering through numerous entry points 92 . The main difficulties relating to controls of imported products are due to a lack of jurisdiction of Market surveillance authorities outside of their Member State, and to a lack of direct communication between Market surveillance authorities and businesses, particularly – again - in the context of online sales. As a consequence, businesses are not willing to collaborate with Market surveillance authorities' requests for corrective actions, for information/documentation or for paying penalties for non-compliance. 65% of authorities participating in the public consultation confirm authorities do not know how to identify and contact businesses located in third countries and 59% confirm that businesses contacted do not reply to requests for information/documentation and for corrective action. Despite some existing informal international cooperation arrangements the number of non-compliant products that can effectively be traced backed to the economic operator and sanctioned at the source in 3rd countries remains limited 93 .

Other issues specifically inherent to online sales relate to products directly mailed to consumers, to the high number of intermediaries and to the low level of consumers’ awareness concerning the risks of buying products online.

Table 8: RAPEX notifications by country of origin

2006-2009

2010-2015

Country of origin

Notifications

Annual average

% of total

Notifications

Annual average

% of total

China

2,952

738

54%

6,862

1,143.7

59%

Turkey

108

27

2%

402

67

3%

Germany

271

67.75

5%

380

63.3

3%

United States

121

30.25

2%

298

49.7

3%

Italy

212

53

4%

243

40.5

2%

France

107

26.75

2%

196

32.7

2%

United Kingdom

88

22

2%

174

29

2%

India

44

11

1%

170

28.3

1%

Japan

98

24.5

2%

167

27.8

1%

Poland

87

21.75

2%

155

25.8

1%

Taiwan

79

19.75

1%

119

19.8

1%

Spain

58

14.5

1%

111

18.5

1%

Other

1,232

308

23%

2,288

381

20%

Total

5,457

1,364.25

100%

11,565

1,927.5

100%

Source: RAPEX database

Because of resource constraints the number of product compliance checks by customs remains fairly limited in relation to the number of imports 94 . Stakeholders often report that the order of magnitude of controls in one of the biggest harbours is only 0.1%.

6.1.4.Conclusion as regards EQ1

The above sections show the specific objectives identified in the impact assessment for the Regulation ((i) enhanced cooperation among Member States, (ii) uniform and sufficiently rigorous level of market surveillance, (iii) border controls of imported products) were only partly fulfilled.

EQ2 - Are there specific forms of the implementation of the Regulation at Member State level that render certain aspects of the Regulation more or less effective than others, and – if there are – what lessons can be drawn from this? 95

EQ3 -    To what extent has the different implementation (i.e. discrepancies in the implementation) of the initiative in Member States impacted on the effectiveness of the measures on the objective? 96

The Regulation has been differently implemented across the EU. The first element of differentiation between Member States is their national organisation of market surveillance structures 97 .

Each Member State organises market surveillance in a way that best suits its particular cultural and legal framework or legal system, so that there is no “one size fits all”. The lack of structured data on product non-compliance and on market surveillance activities makes the establishment of a causal link between the national organisation and the effectiveness of enforcement action not straightforward. Organisational models influence how market surveillance is performed, resulting in differences across the EU. For instance, as shown in the figure below, Member States with a centralised structure need to rely on fewer and simpler cooperation tools. In contrast, the more a Member State is decentralised, the more it needs to set up numerous and complex cooperation mechanisms. 98

Figure 18: Existing correlation between the level of decentralisation of market surveillance and the complexity of cooperation tools within a Member State 99

Crucial elements for the effectiveness of decentralised models are a clear attribution of tasks among authorities and to each MSA (i.e. that market surveillance is not just one "among other tasks" that a MSA has to perform in its daily activities – this also impacting on cost-effectiveness), the existence of a coordination board, the possibility for each MSA to have direct contacts with Customs, the visibility (to the public) of identity and contacts of relevant competent authorities. As far as the sector-decentralised model is concerned, formal channels and procedures for coordination are essential to have coherent policy approaches in different sectors. The crucial aspect for the local-decentralised model is to have a strong coordination body granting not only coherent policy approaches in different regions, but also coordination of investigations via a common database and a tool for common decision making.

A second element of differentiation is represented by available resources. As discussed, financial, human and technical resources vary greatly across Member States. There are significant differences in terms of budget availabilities to implement the Regulation’s provisions across Member States. Overall, the budget available for market surveillance decreased between 2010 and 2013 though variations at the national level did not follow a common trend. The budget indeed increased in nine Member States, decreased in seven and remained stable only in two. Possibly as a consequence of budget reduction, the number of inspectors also decreased. This picture suggests a diffused lack of resources for Market surveillance authorities, as also widely confirmed by stakeholders. In general, this is indicated as one of the main bottlenecks to market surveillance implementation and effective deterrence.

The different levels of resources however have implications on the way Market surveillance authorities perform their tasks and therefore deserve consideration. For instance, Market surveillance authorities’ market knowledge in order to target checks is not sufficient in sectors that require specific skills. Moreover, few market surveillance authorities have their own in-house laboratories for product testing in the construction and in the chemical sector. Testing products is more costly and time consuming than simple documentary checks, since it often involves test laboratories and an officer is usually able to check only a few products per week (excluding the follow-up activities). The excessive costs of testing have been reported as the most likely explanation for the low level of surveillance in some sectors and they are, therefore, another possible explanation for the data gaps in the national reports. Inspections and testing in some areas are so costly that Market surveillance authorities usually perform or consider performing only documentary checks, this further confirming an unequal enforcement of market surveillance across sectors and across Member States. The higher or lower availabilities of laboratories for product testing seems to confirm a tendency to perform more or less laboratory tests at the national level.

The availability of resources also influences Market surveillance authorities’ criteria for prioritisation of monitoring and enforcement activities. For instance, Market surveillance authorities and Customs determine the “adequate scale” of controls first on the basis of financial and human resources rationalisation, and then of product risk level. However, the Regulation requires Member States to give Market surveillance authorities all the resources they need “for the proper performance of their tasks”. This would imply that first Market surveillance authorities determine their targets in terms of controls, and sufficient resources would be given as a consequence. This may actually explain the low number of controls. Interestingly, the German Product Safety Act defines the adequate number of products to be tested by means of a “sample rate” (i.e. 0.5 products per thousand inhabitants per year, as an indicative target for each Federal State). The establishment of a clear benchmark makes it easier to calculate the number of MSA working hours and staff needed to perform such tests. However, the measure of adequate scale also depends on product features (i.e. whether it is a serial or single product).

Differences are also traced in Market surveillance authorities’ strategies for market surveillance. In general, proactive market surveillance is more cost-efficient than reactive market surveillance, because required resources can be defined in advance. However, not all market surveillance activities can be planned ahead. In order to avoid duplication, a market surveillance authority should check ICSMS and any other appropriate platforms (e.g. national database) to see if the same product has already been assessed. Once again it can be concluded that market surveillance is not uniform across the EU, being also strategically influenced by the level of resources, which is different from one Member State to another.

Powers attributed at the national level and the role of Customs in enforcing the Regulation influence the effectiveness of border control. For instance, based on the available data, 16 Member States do not have in-house testing laboratories for any (or almost any) sectors. The lack of laboratories, resulting in the impossibility for Customs to perform more in-depth and time-efficient controls, hinders potential improvement in border controls. However, in some Member States where Customs do not have laboratories, this shortcoming is compensated by Market surveillance authorities having their own laboratories in some sectors. On the one hand, this confirms that the testing is performed. On the other hand, the intervention of two different authorities (i.e. Market surveillance authorities and Customs) could make procedures slower.

Furthermore, controls are expected to be tougher in Member States where Customs act as Market surveillance authorities. If Customs have market surveillance powers, there is a substantial extension of their area of competence and a significant need for in depth expertise. While Customs powers are essential for the control of traded products, the introduction of Regulation (EC) No 765/2008 highlights the need for cooperation between Customs and Market surveillance authorities and with other EU Customs as a crucial element for enhancing market surveillance on imported products. In this respect, there are notable differences across Member States.

Overall, it seems these discrepancies are made possible by the general requirements set in the Regulation. This lack of specificity concerns the obligations of Member States as regards organisation (Article 18(3)). The Regulation foresees that Member States shall entrust Market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks. However, without setting any minimum criteria or thresholds, this results in a wide variety of implementation forms, especially in terms of endowments of powers and resources. These are not always sufficient to grant an effective enforcement. The same considerations can be drawn of Article 19, stating that Market surveillance authorities shall perform “appropriate checks of products on an adequate scale”. As discussed, the “intensity” of market surveillance and the types of checks performed vary across Member States, this further deepening the differences in the enforcement levels.

Article 18(5)-(6) requires a periodical update of national programmes and a review of the functionality of market surveillance activities every four years, but it does not mention any timing for update, neither does it provide any specific methodologies for the review. The provision therefore does not foresee the provision of structured information from Member States to the European Commission relating to market surveillance activities, which is particularly evident in light of all the data limitations of national programmes and reports described in previous sections. This lack of harmonisation makes the national programmes and reports not immediately comparable across countries, which is a missed opportunity for Member States to benchmark and learn from each other’s experiences.

The Regulation does not include specific provisions related to certain forms of cooperation between Member States, notably mutual assistance. This clearly impacts on the existing cooperation mechanisms and tools, as described in the previous sections. Finally, the Regulation is not specific enough to set a minimum and/or a maximum level of penalties, or any principles to define them. As discussed, this results in wide differences in the minimum/ maximum amounts within and across Member States, which lower the enforcement deterrence power.

An additional enabling factor has been identified in the (lack of) cooperation between enforcement authorities and businesses. Among the main reasons for product non-compliance in the internal market there seems to be a lack of economic operators’ knowledge on the relevant legislative requirements to be complied with, as well as a deliberate choice to exploit market opportunities at the lowest cost, possibly due to low incentives to comply with the existing rules. Several stakeholders expressed a need for a higher level of information flow from Market surveillance authorities to businesses and more practical guidance for economic operators. In the context of the interviews, an EU industry association suggested giving economic operators that are willing to comply the opportunity to do so before imposing sanctions, while another EU industry association suggested organising educational campaigns targeting economic operators.

EQ4 - How effective was the measure as a mechanism and means to achieve a high level of protection of public interests, such as health and safety in general, health and safety at workplace, the protection of consumers, protection of the environment and security? What have been the quantitative and qualitative effects of the measure on its objectives?

The table below presents the average annual number of RAPEX notifications per category of products divided into two periods, i.e. 2006-2009 and 2010-2015, where 2010 is the year of the Regulation’s entry into force.

Table 9: Annual average of RAPEX notifications by product category over the periods 2006-2009 and 2010-2015

Product category

2006-2009

2010-2015

Average ∆%

Chemical products

24.5

49.83

103%

Childcare articles and children's equipment

72

62.17

-14%

Clothing, textiles and fashion items

1,54.5

512.67

232%

Communication and media equipment

7.25

13.50

86%

Construction products

0.75

9.33

1,144%

Cosmetics

66.75

75.83

14%

Decorative articles

18.5

15.17

-18%

Electrical appliances and equipment

158.5

181.33

14%

Food-imitating products

30.25

22.33

-26%

Furniture

12.5

13.00

4%

Gadgets

4.25

2.00

-53%

Gas appliances and components

9.5

8.33

-12%

Hand tools

3.5

0.83

-76%

Hobby/sports equipment

29.75

32.67

10%

Jewellery

6.5

32.67

403%

Kitchen/cooking accessories

10.25

10.17

-1%

Laser pointers

9.25

16.67

80%

Lighters

27

23.17

-14%

Lighting chains

31.75

31.83

0%

Lighting equipment

77

56.50

-27%

Machinery

22.5

20.17

-10%

Motor vehicles

154.75

183.17

18%

Other

10.75

41.83

289%

PPEPPE

13.25

32.17

143%

Pyrotechnic articles

0.5

14.83

2,866%

Recreational crafts

6.5

4.33

-33%

Stationery

7.5

2.17

-71%

Toys

393.75

458

16%

Total

1209.25

1927.5

59%

Overall, these increasing trends are consistent with those reflected in the national reports. As reported therein, Market surveillance authorities’ inspection activities resulting in a finding of non-compliance registered a positive average annual growth over the period 2010-2013 (13%), rising from 11,945 in 2010 to 18,316 in 2013 100 .

In order to better understand these increasing trends, it was useful to verify whether the average number of notifications is correlated wto the value of harmonised products traded in the internal market over the two periods considered (i.e. 2006-2009 and 2010-2015). However, since the product categories included in RAPEX slightly differ from the classifications available for the market analysis, only the following product categories were examined; a positive growth in the number of notifications is registered in five categories:

Table 10: Annual average value of harmonised traded products and average number of RAPEX notifications by product category over the periods 2006-2009 and 2010-2015 101

Product category

Value of Harmonised traded products

(Average '06-'09

€)

Value of Harmonised traded products

(Average '10-'15

€)

Δ% Traded products

Δ% RAPEX Notifications

Chemicals

1,067,897,632,898

1,106,833,111,374

3.6%

103%

Construction

156,586,485,690

128,882,492,028

-17.7%

1,144%

Textiles

104,626,637,224

104,598,300,839

-0.03%

232%

Cosmetics

17,870,226,314

15,421,496,892

-13.7%

14%

Appliances burning gaseous fuels

2,236,818,858

2,062,761,701

-7.8%

-12%

Machinery

278,111,694,212

271,828,263,683

-2.3%

-10%

Motor vehicles and tractors

338,802,673,379

329,544,444,282

-2.7%

18%

Simple pressure vessels and pressure equipment

243,498,460,356

248,009,349,724

1.9%

-

Personal protective equipment

33,664,105,623

35,624,391,429

5.8%

143%

Pyrotechnics

2,314,375,580

2,302,762,034

-0.5%

2,866%

Recreational craft

6,185,094,424

5,755,650,303

-6.9%

-33%

Toys

9,359,483,585

12,004,549,187

28.3%

16%

Total

2,261,153,688,142

2,262,867,573,475

0.1%

59%

Overall, there are still many products in the EU market that do not comply with legislative requirements. Similarly, the number of restrictive measures imposed by market surveillance authorities in reaction to non-compliant products has increased. Interestingly, the most significant increases have been registered in the most “coercive” measures (i.e. seizure, withdrawal, destruction). Other measures such as requests for information or corrective actions have even decreased. This could indicate that not only has non-compliance increased, but that its seriousness has worsened. Similar conclusions can be drawn on the measures undertaken by economic operators to correct non-compliance.

These findings are confirmed by data from ICSMS:

Table 11: Data from ICSMS

0 - No defects identified

1 - Low risk

2 - Medium risk

3 - High risk

4 - Serious risk

2008

574

1.034

1.153

927

0

2009

476

1.094

1.069

888

0

2010

765

956

870

776

222

2011

1.207

1.084

667

633

132

2012

1.185

1.098

845

327

257

2013

1.269

1.539

1.087

543

442

2014

1.256

2.537

1.138

683

367

2015

1.345

1.951

902

759

408

2016

1.239

1.324

859

678

381

9.316

12.617

8.590

6.214

2.209

The evidence of an increasing number of non-compliant products covered by harmonisation legislation (as demonstrated by the rising number of RAPEX notifications and of restrictive measures taken by Market surveillance authorities) allows a conclusion to be drawn that the Regulation is not fully effective in relation to its strategic objectives of strengthening the protection of public interests through the reduction of the number of non-compliant products on the Internal Market and of ensuring a level playing field among economic operators providing a framework for market surveillance and controls of products. On the one hand, the increasing product non-compliance threatens the achievement of a high level of protection of public interests as long as these products present risks to consumers and end-users. On the other hand, a level-playing field among businesses trading goods subject to EU harmonisation legislation risks not being achieved as long as there is still the possibility for rogue traders to disregard legal requirements and sell non-compliant products.

EQ5.    How effective was the measure as a mechanism and means to achieve a level playing field among businesses trading in goods subject to EU harmonisation legislation? What have been the quantitative and qualitative effects of the measure on its objectives? 102

As already discussed, the Regulation has been implemented in different ways across Member States, resulting in an unequal level playing field among businesses in some Member States. Moreover, these discrepancies diminish the Regulation’s effectiveness in achieving a level playing field, inasmuch as they influence regulatory/ administrative costs to businesses across Member States (e.g. preparing documents and information requested by Market surveillance authorities/Authorities in charge of EU external border controls in implementing surveillance measures). Similarly, these discrepancies influence market behaviour (e.g. decision of companies to enter the EU market via certain Member States)

On the other hand, however, the average number of RAPEX notifications has increased from one period to another in most Member States, with very few exceptions, which suggests that the Regulation has apparently triggered an increase in enforcement. Similarly, the number of restrictive measures imposed by Market surveillance authorities in reaction to non-compliant products has increased.

Table 12: Average annual number of RAPEX notifications on measures undertaken by market surveillance authorities over 2005-2009 and over 2010-2015

2005-2009

2010-2015

∆%

Total

Recall

184.4

288

56%

2,648

Withdrawal

428.2

803

88%

6,959

Destruction

11.8

18

55%

169

Ban

242

236

-2%

2,627

Seizure

10

27

167%

210

Corrective Actions

21.2

16

-27%

199

Information

16

2

-91%

89

Total

913.6

1,389

52%

12,901

Source: RAPEX database

Similar conclusions can be drawn on the measures undertaken by economic operators to correct non-compliance. Since the entry into force of the Regulation, the most significant increase has been registered in the average number of notifications relating to product destructions.

Table 13: Average annual number of RAPEX notifications on measures undertaken by economic operators over 2005-2009 and over 2010-2015

Measure

2005-2009

2010-2015

∆%

Total

Recall

225.8

334.7

48.2%

3,137

Withdrawal

334

332.7

-0.4%

3,666

Destruction

15.8

35.3

123.6%

291

Ban

10.8

15.8

46.6%

149

Information

28.8

3.3

-88.4%

164

Total

615.2

721.8

17.3%

7,407

Source: RAPEX database

In conclusion, it is fair to say that the Regulation has not yet created a level playing field for businesses across the EU in light of the significant discrepancies in its implementation and of the dimension of product non-compliance. An unequal implementation also creates disparities in the level of enforcement and thus differences in the burden of controls borne by economic operators, which in some Member States and in some sectors is higher than in others. In addition, the increase in the number of non-compliant products signals that there are rogue traders that can still benefit from lower compliance costs, thus further hindering the achievement of a level-playing field within the internal market.

6.2.Efficiency

EQ6.    What are the regulatory (including administrative) costs for the different stakeholders (businesses, consumers/users, national authorities, Commission)? 103

The efficiency of the Regulation has been assessed in terms of costs incurred by different stakeholders, benefits produced, and the extent to which desired effects (results and impacts) have been achieved at a reasonable cost.

As regards economic operators the evaluation has looked at possible costs related to information obligations as defined in Article 19 of the Regulation which are perceived as insignificant. On the other hand there is no evidence of any regulatory costs from the implementation of the market surveillance provisions. Compliance costs for businesses stem from the requirements in the harmonisation legislation, not from market surveillance provisions. Conversely, stakeholders argue that weak implementation would lead to supplementary costs. They indicate that ineffective controls at the EU’s external borders might create discrimination against European manufacturers as compared to their non-European competitors in the European internal market as well as the associated distortions of competition. They also suggested that the identification of non-compliant products might be reinforced by more effective cooperation between industry and authorities. In this way, market surveillance authorities could take advantage of manufacturers’ technical knowledge and might be in a better position to identify non-compliant products on the market and more efficiently set appropriate priorities for market surveillance activities.

No regulatory costs have been identified for consumers/users.

Most of the costs of the market surveillance provisions are borne by Member States and their market surveillance authorities 104 . Enforcement costs for authorities are estimated on the basis of all financial resources assigned to market surveillance activities including communication and enforcement, related infrastructures as well as projects and measures aimed at ensuring compliance of economic operators with product legislation. Considering the limitations of the available data in terms of completeness and comparability, an estimation of the costs related to surveillance obligations is only possible for a limited number of countries that provided complete and reliable data in the reports. Even if the nominal budget for the countries considered remained virtually constant, the yearly number of inspections increased by 21%, while the yearly average number of tests in laboratories decreased by 7%.

Table 14: Market surveillance authorities’ average number of inspections, costs of inspections and cost of tests

MS

Nominal budget (Av. ‘10-’13)

Δ%

2010 - 2013

Number of inspections (Av. ‘10-’13)

Δ%

2010 - 2013

Average cost of inspections €

Number of tests performed in laboratories (Av. ‘10-’13)

Δ%

2010 - 2013

Average cost of tests €

(a)

(b)

(a)/(c)

(d)

(a)/(d)

BE

946,903

-32%

4,701

94%

201

386

-45%

2,452

BG

2,114,559

-16%

10,953

58%

193

466

21%

4,535

CZ

384,594

-5%

6,200

-4%

62

166

-55%

2,313

DK

8,386,750

0%

1,754

14%

4,782

561

0%

14,950

FI

1,417,861

0%

7,448

0%

996

2924

6%

2,537

FR

1,680,000

1%

16,119

-1%

104

1147

-1%

1,465

IE

4,825,000

0%

15,401

32%

313

193

-58%

25,000

IT

1,561,372

6%

6,110

11%

256

581

153%

2,690

LV

1,818,645

40%

3,221

-1%

565

361

63%

5,038

MT

163,592

7%

939

-7%

174

:

:

:

PL

10,229,088

16%

7,605

5%

1,345

926

44%

11,047

PT

25,229,517

-16%

12,670

174%

1,991

411

-9%

61,348

RO

320,108

25%

12,071

-14%

27

2716

-35%

118

SE

14,258,602

n/a

3,593

-3%

3,968

367

-14%

38,852

SK

5,634,232

-1%

3,610

-31%

1,561

352

-30%

15,995

Av.

5,264,722

0.92%

7,493

21%

703

770

-7%

6,837

The fact that every Member State defines its own market surveillance approach (e.g. distribution of competence, interpretation of the concept of appropriate scale of controls, penalties) creates a high variation in the ways the different sectors are controlled and managed. Moreover, fragmentation throughout the Internal Market may interfere with Authorities’ early action and generate additional costs for businesses. Favouring a more consistent approach to market surveillance would there help reducing regulatory burden on economic operators. Different approaches may also reduce the efficiency of the market surveillance when responsibilities of national authorities are not primarily related to market surveillance of non-food products within the meaning of the Regulation and this creates overlapping and duplication of activities.

The analysis of the efficiency of the Regulation has been limited by the evident poor quality of data included in the national reports both in terms of completeness and comparability. This definitely shows the need for an in-depth reflection of the monitoring mechanisms in place that should allow the European Commission to get an updated and realistic picture on the implementation of the Regulation within the scope of this evaluation.

In addition there seems to be room for improvement in the drafting of national programmes. The administrative burden relating to this provision indeed seems sometimes higher than the benefits, especially because certain aspects of market surveillance activities do not change every year 105 .

Streamlining the procedures for the notification of non-compliant products, which is currently carried out thorough two separate systems (Rapex and ICSMS), could further reduce administrative burden for authorities 106 .

Unavailability of data about costs incurred by Member States Authorities in charge of market surveillance before 2008 did not allow for the calculation of additional costs deriving from new obligations introduced by the Regulation.

EQ7.    What are the main benefits for stakeholders and civil society that derive from the Regulation? 107

During interviews, business’ associations were asked whether their industry had benefited from cost savings since the entry into force of the Regulation. The majority of the associations did not report cost savings as a result of the implementation of the Regulation in terms of administrative and operational tasks if compared to the situation prior to 2008. Furthermore, most stakeholders involved did not perceive a substantial variation in product non-compliance considering the period from 2010 to 2015; however the number of stakeholders that perceived an increase in product non-compliance is higher than the numbers of the stakeholders that perceived that product non-compliance diminished. This seems to be also confirmed by the increased number of RAPEX notifications and corrective measures taken by the Market surveillance authorities in the last few years.

Figure 19: Perceived level of product non-compliance in the last 5 years (80 responses)

The analysis of responses to the survey highlights also that ‘Toys’, ‘Chemicals’ and ‘Electrical appliances under the Low Voltage Directive’ seem to be the sectors were the product non-compliance is more problematic. However, only for toys and chemicals is this perception confirmed by the indicators used to measure product non-compliance in the internal market.

Figure 20: Sectors heavily affected by product non-compliance (34 responses)

Therefore, the Regulation does not seem to be producing the envisaged benefits and the problem relatng to product non-compliance still remains. However, it is not possible to measure how this has impacted safety and uniform protection of consumers across the EU.

EQ8.    To what extent have the market surveillance provisions been cost effective? 108

EQ9.    Are there any significant differences in costs (or benefits) between Member States? If so, what is causing them?

Table 14 on Market surveillance authorities’ average number of inspections, costs of inspections and cost of tests show significant differences in the costs between Member States. The low correlation between the number of inspections and the size of national markets was explained in section 6.1.2.1. This is further proved by the comparison of the financial resources allocated to surveillance activities at Member State level with the size of local market of harmonised products when (imperfectly 109 ) measured by the average number of enterprises active in the national market as the average annual budgets allocated to MSA activities are not correlated with the number of enterprises active in the harmonised sectors.

Figure 21: Average annual budget available to Market surveillance authorities in nominal terms vs average no. of enterprises active in Harmonised sectors

Source: Authors’ elaboration on data from national reports and SBS (2016)

The differences in the budgets allocated to MSA activities and average costs might be related to the fact that Member States have different organisational models requiring different levels of financial resources. However, another possible explanation might be sought in the different approaches followed by Market surveillance authorities in reporting data concerning the used financial resources as well as the performed activities (e.g. definition of 'inspection').

With regards to benefits, evidence already shown on the increase in the adoption of restrictive measures and corrective actions undertaken by economic operators shows that product non-compliance increased consistently from 2006-2009 to 2010-2015. As already mentioned, this data could be interpreted in two opposite ways, inasmuch as an increase in RAPEX notifications may also imply that Market surveillance authorities have become more effective in finding – and thus correcting – non-compliance. In any case, they indicate that a number of non-compliant products are still made available in the Single Market and that therefore the goals of the Regulation have not been fully achieved. No differences have been identified in country-specific patterns.

6.3.Relevance

EQ10.    To what extent are market surveillance provisions of the Regulation still relevant in light of for instance increasing online trade, the increase in imports from third countries, shortening product life, increasing budgetary constraints at national level, etc.? 110

The relevance of the market surveillance provisions in view of new developments is becoming increasingly problematic:

111 112 The overall limited relevance of the Regulation to online sales, including from third countries, is underlined by stakeholders. The concepts of 'online trade' and 'e-commerce' do not appear in the provisions, and the definitions do not refer to online traders. One could argue that the provisions are sufficiently neutral to cover which ever form of trade, but the input from interested parties clearly shows that the market surveillance provisions fail to provide clear solutions for market surveillance on online trade, notwithstanding the existing guidance. Market surveillance on products sold online is particularly challenging, and the Regulation does not seem to be able to properly address related specificities. Specifically, the Regulation does not include specific provisions covering online sales, nor does it provide for definitions that account for its specificities. As mentioned above, the same definitions of “making available on the market” and “placing on the market” do not consider the complex distribution chains of online sales, as also highlighted by some stakeholders when discussing both import from third countries and online sales. Also, when considering the economic operators involved in the online sales supply chain, the Regulation does not reflect the latter complexity, for example leaving a grey area on whether fulfilment houses, which according to various stakeholders represent an increasing concern, should be subject to market surveillance. In general the Regulation does not specify if and how surveillance authorities can request information and cooperation from new types of economic actors playing a role in the supply of online sales but who may not fall within the traditional definitions of economic operators.

113 Box 4 – Fulfilment service providers

During the last years, there was a lively debate among market surveillance authorities and businesses whether the market surveillance provisions also apply to new types of businesses in e-commerce, such as 'fulfilment service providers'.

Fulfilment services can be described as services provided by a company that will store products, receive orders, package products and ship them to customers. There is a wide range of operating scenarios for delivering fulfilment services. Some fulfilment service providers offer all of the services listed above, while others only cover them partially. Their size and scale also differ, from global operators to micro businesses operating from small premises. Their willingness to collaborate with authorities also varies; some fully cooperate with authorities, while others do not, mostly because they are not aware of the safety and compliance obligations applicable to the products they store/deliver.

This new business model of use of fulfilment service providers raises challenges for authorities, especially when the economic operator selling the goods (manufacturer, online platform) is located outside the EU and the transfer occurs directly between that economic operator and the consumer located in the EU, without any identifiable responsible economic operator within the EU to be held accountable. The only identifiable EU economic operator in the supply chain is the fulfilment service provider that stores the goods.

When only the fulfilment service provider is located in the EU, the only way for authorities to verify that products comply with EU applicable legislation is to contact the fulfilment service provider, which may not cooperate on a voluntary basis. In order to take investigatory or enforcement actions, authorities would need a strong legal basis which prevents any risks to successful prosecution.

114 Products stored in such fulfilment houses are considered to have been supplied for distribution, consumption or use in the EU market and thus placed on the EU market. When an online operator uses a fulfilment house, by shipping the products to the fulfilment house in the EU the products are in the distribution phase of the supply chain. The Commission indicated that the activities of fulfilment service providers go beyond those of parcel service providers that provide clearance services, sorting, transport and delivery of parcels. The complexity of the business model they offer makes fulfilment service providers a necessary element of the supply chain and therefore they can be considered as taking part in the supply of a product and subsequently in placing it on the market. Thus, where fulfilment service providers provide services as described above which go beyond those of parcel service providers, they should be considered as distributors and should fulfil the corresponding legal responsibilities. Taking into account the variety of fulfilment houses and the services they provide, the Commission concluded that the analysis of the economic model of some operators may conclude that they are importers or authorised representatives. However, several member States indicated that this guidance is unsatisfactory.

The market surveillance provisions in the Regulation provide national authorities with basic powers (request information, take product samples, enter business premises) however they do not specifically take into account the shortening life of a number of mass products, which require for instance increased cooperation with the relevant economic operator, ability to act quickly to restrict the marketing of non-compliant goods (also taking necessary interim measures) and informing consumers.

115 Similarly, the market surveillance provisions only address in very general terms that Member States have to entrust their market surveillance authorities 'with the powers, resources and knowledge necessary for the proper performance of their tasks.' Yet, it is undisputable that the resources for market surveillance authorities were reduced in many Member States as a direct consequence of budgetary constraints, and that the market surveillance provisions were not relevant in addressing this problem.

EQ11.    To what extent do the effects of the market surveillance provisions satisfy (or not) stakeholders' needs? How much does the degree of satisfaction differ according to the different stakeholder groups? 116

Overall, the Regulation meets stakeholders’ needs in the sense that it is relevant in relation to their needs. Stakeholders consider the existence of market surveillance provisions as a major step forward, compared to the situation before 2010, while pointing to cross-border cooperation and controls at the external borders as areas where progress can be made 117 .

Market surveillance authorities identified different topics to which the Regulation does not provide satisfactory answers and where progress could be made ('common challenges') 118 :

(1)Current control procedures are not suitable for handling products sold online. Moreover, for effective market surveillance of products sold on the internet and that are offered from outside the EU, collaboration with customs authorities is of crucial importance.

(2)There is a need to reinforce customs controls. Furthermore, to make it harder for non-European manufacturers, whose non-compliant products have been rejected by a customs authority, to switch to other customs clearance locations, improved cooperation between the customs authorities of the EU Member States also seems necessary. For some Member States there exists a mismatch between the customs product classification and the nomenclature used by market surveillance authorities, which hamper cooperation in some areas.

(3)There is the difficulty of dealing with products from third countries sold via informal channels (marketplaces), and the ineffectiveness of market surveillance techniques in this case.

(4)Penalties laid down in national law might not be a sufficient deterrent, in particular in the case of larger companies trying to market non-compliant products;

(5)There is a lack of knowledge amongst economic operators about applicable product rules. In some sectors formal requirements such as technical documentation and CE marking are disregarded by businesses, possibly due to lack of knowledge or misunderstanding of those requirements.

(6)There is a lack of cooperation by certain economic operators and some abuse by businesses of the legal principles concerning the notification of restrictive measures contained in Article 21 (1) and (2) of Regulation (EC) 765/2008.

Consumer and business organisations views point in the same direction. They indicate that Regulation (EC) No 765/2008 goes in the right direction to achieve effective or efficient enforcement of EU product rules but that market surveillance should be further strengthened 119 .

EQ12.    Is there an issue on the scope (i.e. all EU product harmonisation legislation) of the measure or some of its provisions? 120

Article 15 of Regulation (EC) No 765/2008 defines ‘[Union] harmonisation legislation’ as ‘[Union] legislation harmonising the conditions for the marketing of products’. Union harmonisation legislation includes the legislation that expressly confirms that the market surveillance provisions apply 121 . Other Union harmonisation legislation also refers to these provisions 122 . Although there is no cross-reference between the market surveillance provisions and the legislation listed below, there seems to be no doubt among stakeholders that the definition of Article 15 includes the so-called 'New Approach' legislation as well as other legislation on non-food products 123 .

Yet, it is unclear whether Articles 15 to 26 of the market surveillance provisions 124 apply to other directives and regulations. For example, the question arises if other Union legislation falls within the scope of Regulation (EC) No 765/2008, and especially Union legislation that either regulates certain aspects of the marketing of products, or merely restricts or prohibits the marketing of products 125 . Some confusion on the scope of the Regulation has emerged also from the analysis of national reports (some of which added sectors not in the scope of the Regulation), and considering input from economic operators.

Notwithstanding the lack of clarity of the scope, there seems to be a common understanding that Union legislation that regulates commercial practices 126 is excluded from the scope of the market surveillance provisions. Its enforcement is subject to Regulation (EC) No 2006/2004 of the European Parliament and of the Council of 27 October 2004 on cooperation between national authorities responsible for the enforcement of consumer protection laws (the Regulation on consumer protection cooperation).

The issue of the scope was also raised in a UK public consultation 127 about the pending 'Market Surveillance proposal' 128 , 13 respondents (7 trade associations, 2 government agencies, 1 local authority, 1 individual, 1 micro business and 1 ‘other’) did not think the scope gave enough clarity on the coverage provided by market surveillance activity on certain products, whilst 19 respondents (9 trade associations, 2 government bodies, 2 local authorities, 5 large businesses and 1 ‘other’) thought that it did. Of those that considered that the proposal’s scope did give enough clarity, 4 respondents (3 trade associations, 1 government body) thought that, although the scope was generally sufficiently clear, clarification was needed for specific provisions pertinent to their own interests. Similar remarks were made by European business associations and during the Council Working Party meetings about the proposal.

EQ13.    Is the concept of lex specialis still a suitable interface between the market surveillance provisions in the Regulation and those in other (notably sector) legislation? 129

The market surveillance provisions constitute 'lex generalis' in two ways:

·Firstly, Article 15(2) specifies that each of the provisions of Articles 16 to 26 (i.e. the Union market surveillance framework) apply in so far as there are no specific provisions with the same objective in Union harmonisation legislation.

·Secondly, Articles 27, 28 and 29 (i.e. controls of products entering the Union market) apply to all products covered by Union legislation in so far as other Union legislation does not contain specific provisions relating to the organisation of border controls.

The purpose of this 'lex generalis'-principle is to solve any conflict between legal rules. One way to organise relationships between different legal rules is to conceive them in terms of relations between what is "general" to what appears "particular". The question of how to deal with specialised sets of rules in their relationship to general law and to each other is usually dealt with by two sets of doctrines: the interpretative maxim lex specialis derogat lex generali and the doctrine of self-contained regimes. Legal literature generally accepts the lex specialis as a valid general principle of law 130 . In accordance with the principle lex specialis derogat legi generali, special provisions prevail over general rules in situations which they specifically seek to regulate 131 . Many stakeholders consider that the concept of lex specialis is a suitable interface to address market surveillance in specific sectors, as it is relevant and causes no difficulties in implementation 132 .

One of the difficulties in the lex specialis rule follows from the relative unclarity of the distinction between "general" and "special". It follows that no rule can be determined as general or special in the abstract, without regard to the situation in which its application is sought. Thus, a rule may be applicable as general law in some respect while it may appear as a particular rule in other respects 133 . This principle is often difficult to apply in practice and requires a careful comparison between two sets of rules. As a result, it is not straightforward to assess which provisions of the Regulation apply and which articles of the sector-specific legislation are covered by the lex specialis principle. These interpretation problems often result in an excessive administrative burden and in legal uncertainty 134 .

6.4.Coherence

EQ14 -    To what extent are the market surveillance provisions coherent internally? 135

As for internal coherence, overall, the market surveillance provisions of the Regulation are consistent within themselves and in the scope of the legislation. Furthermore roles and tasks of all different stakeholders concerned by the Regulation are well-defined and no duplication of activities has been traced. The analysis – supported by stakeholders’ opinions - has not identified any overlaps or contradictions between the Regulation’s provisions in scope of this study. However, some areas for improvements have been identified. In this respect, there are areas where further guidance and clarity would be beneficial For instance, the Regulation does not provide any specific methodology to be followed by the Member States to review and assess the functionality of the surveillance activities. Similarly, the Regulation does not include provisions related to the principles of cooperation between the Member States (i.e. spontaneous and/by request provision of information, fullest availability for cooperation, reciprocity basis, including in case of negative response/no information). At present, provisions about the implementation of market surveillance are too general, thus allowing for significant differences in the implementation of the Regulation in terms – for instance – of communication and collaboration tools existing within/among Member States, endowments of powers and resources, “adequacy” of checks.

EQ15 - To what extent are the market surveillance provisions above still coherent with other Union legislation on market surveillance on non-food products? 136

Most of the market surveillance provisions are coherent with other Union legislation setting out market surveillance procedures, especially the legislation that expressly refers to the market surveillance provisions.

They are also coherent with the Union rules on the enforcement of intellectual property rights. An efficient and effectively enforced intellectual property infrastructure is necessary to avoid commercial-scale intellectual property rights (IPR) infringements that result in economic harm. Directive 2004/48/EC on the enforcement of intellectual property rights lays down the measures, procedures and remedies necessary to ensure the enforcement of intellectual property rights within the single market. In addition, Regulation (EU) No 608/2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 sets out the conditions and procedures for action by the customs authorities where goods suspected of infringing an intellectual property right are, or should have been, subject to customs supervision or customs control within the customs territory of the Union, particularly goods declared for release for free circulation, export or re-export, goods entering or leaving the customs territory of the Union and goods placed under a suspensive procedure or in a free zone or free warehouse.

Yet, there is a substantial difference between the enforcement of, on the one hand, 'private' intellectual property rights and, on the other, public safety and consumer protection rules that all products should comply with. The fact that a product is infringing an intellectual property right is already a strong signal that the product is not likely to comply with Union harmonisation legislation. However, the measures taken pursuant to Directive 2004/48/EC and Regulation (EU) No 608/2013 allow these products to be removed from the market and prevent them from entering the market so that enforcement of Union harmonisation legislation is no longer necessary under these circumstances. Therefore, the market surveillance provisions seem to be coherent with the Union rules on the enforcement of intellectual property rights.

Nonetheless, the market surveillance provisions show some incoherencies with other instruments of EU law that can give rise to interpretation difficulties and so raise regulatory costs for businesses and authorities. The following incoherencies were identified:

a) Economic operator 137

The definition of 'economic operators' in Regulation (EC) No 765/2008 and the definition of economic operators in other Union harmonisation legislation are sometimes incoherent. Article 2 of Regulation (EC) No 765/2008 defines economic operators as ‘the manufacturer, the authorised representative, the importer and the distributor.’ However, several pieces of Union harmonisation legislation create obligations for businesses which are not considered ‘economic operators’ for the purpose of Regulation (EC) No 765/2008 138 . The consequence is that some important provisions of Regulation (EC) No 765/2008 cannot be applied. For example, it allows market surveillance authorities to ‘require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary.’ This will not be possible for economic operators that are not included in the definition of Regulation (EC) No 765/2008.

Conversely, the obligation for market surveillance authorities to cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators, will not apply to other businesses than manufacturers, authorised representatives, importers and distributors. The same thing goes for the obligation of market surveillance authorities of one Member State which decide to withdraw a product manufactured in another Member State, to inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying that product.

b)    Intermediary services providers under the E-commerce Directive 2000/31/EC 

Furthermore, the coherence between the market surveillance provisions and the liability regime of intermediary service providers whose liability is regulated by the Electronic Commerce Directive 2000/31/EC is not entirely clear in many cases. Intermediary service providers carrying out hosting activities benefit from an exemption of liability for damages or criminal sanctions related to the content provided by third parties using their networks. However, the liability exemption is not absolute. In the case of hosting activities, which are the most relevant for the product safety and compliance area, the exemption only applies if the intermediary service provider has no actual knowledge or awareness about the illegal nature of the information hosted and upon obtaining such knowledge or awareness of the illegal content (for instance by a ‘sufficiently precise and adequately substantiated’ notice, it acts expeditiously to remove it or disable access. If they do not fulfil these conditions, they cannot be covered by the exemption and thus they can be held liable for the content they host.

Following Article 15 of the E-commerce Directive, Member States cannot impose either a general obligation on these providers to monitor the content or a general obligation to actively seek facts or circumstances indicating illegal activity. This means that national authorities cannot establish a general obligation for intermediaries to actively monitor their entire internet traffic and seek elements indicating illegal activities such as unsafe products. The ban on requesting general monitoring, however, does not limit public authorities in establishing specific monitoring requirements, although the scope of such arrangements have to be targeted.

In practice, this means that national authorities can contact the hosting providers who, when notified of unlawful activity, if they want to benefit from the exemption of liability, have to remove or disable the content, meaning that the unsafe/non-compliant products would no longer be accessible to EU customers through their services. Yet, in many cases, these national authorities are not necessarily the market surveillance authorities who usually can only act with respect to 'economic operators'.

c)    The GPSD

A specific interpretation problem could arise when the 'lex specialis'-principle is combined with Article 15(3) which specifies that the application of the market surveillance provisions do not 'prevent market surveillance authorities from taking more specific measures as provided for in Directive 2001/95/EC.' The coherence problems relate to the definitions of the GPSD which differ from those of the Regulation. For instance, the definitions of “distributor”, “withdrawal”, “recall” are different from one piece of legislation to the other, while the definitions of “serious risk” and “dangerous products” are set in the GPSD and not in Regulation 765/2008, though the latter widely refers to these concepts. Moreover, the boundary between the GPSD and the Regulation is not always clear as the two pieces of legislation sometimes seem to overlap 139 . These issues were specifically addressed by the Commission in the legislative proposal put forward in 2013, which is still pending.

EQ16.    To what extent are these provisions coherent with wider EU policy?

Wider EU policy on the enforcement of Union legislation, by national authorities, evolved quite profoundly since the market surveillance provisions started applying. The European Commission that came into office in November 2014 has created increasing jobs, growth and investment its top priority and is pursuing it by deepening the Single Market across sectors and policy areas. Better enforcement of Union legislation is one of the key tools to achieve a fairer internal market which is one of the ten policy areas to be tackled under President Juncker's Agenda for Jobs, Growth, Fairness and Democratic Change 140 . Consequently, many new initiatives were tabled by this Commission in order to improve the enforcement of Union legislation by national authorities.

·In the area of food and feed, Regulation (EU) 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products 141 will increase Member States' ability to prevent, eliminate or reduce health risks to humans, animals and plants. The new Regulation provides a package of measures that will strengthen the enforcement of health and safety standards for the whole agri-food chain. The new rules will gradually become applicable with the main application date being 14 December 2019.

·Furthermore, the Commission put forward a proposal for the reform of the Consumer Protection Cooperation (CPC) Regulation 142 , which governs the powers of enforcement authorities and the manner in which they can cooperate. The reform addresses the need to better enforce EU consumer law, especially in the fast evolving digital sphere. The proposal for an improved Regulation will equip enforcement authorities with the powers they need to work together faster and more efficiently.

·In addition, the Commission proposed new rules to enable Member States' competition authorities to be more effective enforcers of EU antitrust rules 143 . The proposal seeks to make sure they have all the tools they require to achieve this. It is intended to further empower the Member States' competition authorities. It aims to ensure that when applying the same legal basis national competition authorities have the appropriate enforcement tools, in order to bring about a genuine common competition enforcement area. The proposed rules, once adopted, will provide the national competition authorities with a minimum common toolkit and effective enforcement powers.

·Stronger enforcement powers are also key issues in other recent legislative initiatives 144 .

Therefore, it is obvious that, in the light of wider EU policy as outlined before, strengthening market surveillance provisions would be coherent with wider EU policy.

The coherence of market surveillance provisions with the EU's policy of helping SMEs and start-ups to grow could be enhanced. Far too many obstacles remain for SMEs, start-ups and young entrepreneurs looking to grow in the Single Market. In particular, SMEs complain about understanding and complying with regulatory requirements. This means that non-compliance should be prevented by helping SMEs to understand and comply with these requirements. However, the provision of information about regulatory requirements is a missing element in the market surveillance provisions and in Union harmonisation legislation in general.

6.5.EU added value

EQ17.    What is the additional value resulting from the market surveillance provisions at EU level, compared to what could be achieved by Member States at national and/or regional levels? 145

The benefits of having a single piece of European legislation harmonising market surveillance instead of several different pieces of national legislation are widely recognised by stakeholders. By setting common requirements relating to the marketing of products, the Regulation per se already achieves a result which cannot be attained by a single Member State’s action. This is particularly relevant if we consider that the shortcomings in one Member State’s market surveillance system are likely to affect a considerable number of other Member States, in light of the absence of national borders within the internal market.

The analysis of the EU added value as per the specific provisions of the Regulation shows that some of them achieve a higher EU added value when compared to others.

The EU added value of the Regulation mainly stems from provisions envisaging common information systems favouring administrative cooperation and enhancing collaboration between customs and Market surveillance authorities. The Regulation has improved cooperation among actors involved in market surveillance activities. In this regard, the management of the RAPEX and ICSMS system at the EU level should not be disregarded, as they are two valuable tools that increase and enhance the exchange of information and open possibilities of collaboration between Member States. Moreover, the framework provided by the Regulation is useful in defining national market surveillance and the control of imported products policies. By clarifying the role of Customs, for instance, the Regulation has also enhanced their channels and opportunities of collaboration with other EU authorities. This benefit appears particularly important for “small countries”.

The EU added value linked to provisions dealing with market surveillance organisations at the national level is limited, mainly because the Regulation does not provide clear guidance on how to have a more homogenous market surveillance system. Finally, it is worth recalling provisions on national programmes and reports. Although they could provide significant EU added value in terms of monitoring of the enforcement of market surveillance, the lack of binding criteria on how they should be drafted and interpreted makes these documents far less relevant than initially expected.

Overall the Regulation therefore has the potential to contribute to the protection of safety and other public interests underpinning Union product harmonisation legislation, to the establishment of a level playing field and to the improvement of the free movement of goods. The harmonisation of rules is reported as a benefit. The Regulation facilitates transparency and unambiguous interpretation of rules, together with cooperation between countries and relevant authorities.

However, the potential for the Regulation to achieve a full EU added value is still hindered by the sub-optimal level of cross-border exchange of information and cooperation, persisting difficulties in dealing with cross-border non-compliance the lack of a uniform implementation of the market surveillance framework at the national level and the insufficient rigour of controls, including on imported products.

EQ18.    To what extent do these provisions support and usefully supplement market surveillance policies pursued by the Member States? Do the provisions allow some sort of 'control' by the EU on the way national authorities carry out market surveillance?

The general view is that the market surveillance provisions support and usefully supplement market surveillance policies pursued by the Member States, especially in cross-border situations 146 . Yet, there seems to be convergence of views that they do not do so sufficiently. The relevant provisions and their implementation should then be profoundly improved.

The current market surveillance provisions do not attribute to the EU institutions any powers to 'control' the way national authorities carry out market surveillance. As mentioned the generality of the provisions setting out minimum requirements for the organisation and the performance of market surveillance does not allow setting benchmarks against which to assess national activities at EU level. On the other hand the market surveillance provisions seem to attribute to the Commission the role of facilitator in relation to the exchange of information among Member States.

7.Conclusions

7.1.Effectiveness

The Regulation has been only partly effective in achieving its specific and strategic objectives.

Although coordination and cooperation has developed significantly, and is recognised as useful, they have not reached a level that can be considered satisfactory. In particular, despite the tools (i.e. RAPEX, ICSMS) that are in place to ensure cross-border market surveillance cooperation, they are not sufficiently used by Member States. As a result, Market surveillance authorities do not fully benefit from the advantages of these systems as they rarely restrict the marketing of a product following the exchange of information on measures adopted by another EU MSA against the same product. Also, the possibility for Market surveillance authorities and Customs to make use of finding (including test reports) by Market surveillance authorities in other EU countries and avoid duplication of work seems to be limited. The value of administrative cooperation which is essential for coordinating actions and learning from best practice is diminished by a lack of active participation in AdCos. The issue of limited resources is often invoked by Market Surveillance authorities to explain sub-optimal use of available coordination tools. In addition because the bulk of the market surveillance framework (powers, procedures) is set nationally authorities perceive market surveillance as a national matter and fail catch the spill over effects of their activities on the functioning of the Single Market. Moreover the lack of an administrative framework for the management of cross-border projects represents an important obstacle to their involvement in actions coordinated with other Member States.

Uniformity and rigorousness of market surveillance has not been achieved yet, due to the significant differences across Member States in the implementation of the Regulation as to the organisation of market surveillance at the national level, the availability of resources (financial, human and technical), the strategies of market surveillance, the powers of inspection and of sanctions and the systems of monitoring and reporting. The general character of the Regulation’s requirements is likely to have allowed these different implementations.

The heterogeneity existing across Member States in the implementation of the Regulation allows an inference to be drawn that the level of market surveillance is certainly not uniform, given that Member States with more resources and powers have - at least - more tools for proper enforcement. As for its rigorousness, the serious lack of data and inhomogeneity of national reports do not allow for a thorough assessment. However, on the basis of the information available, the amount of resources attributed to market surveillance and activities reported cast some doubts on the ability of market surveillance authorities to perform checks at an adequate scale. Lack of relevant information may in some cases be an indication of actual enforcement gaps. The insufficient rigorousness of market surveillance is further supported by the stakeholders’ perception about the incapacity of the Regulation to deter rogue traders and the discrepancies in the penalty framework.

The border controls on imported products seem insufficient. The main difficulties are due to a lack of jurisdiction of the Market surveillance authorities outside of their Member State, particularly in the context of online sales.

The Regulation is not fully effective in relation to its strategic objectives of strengthening the protection of public interests and of ensuring a level playing field among economic operators through the reduction of the number of non-compliant products on the Internal Market. Data available actually point to the persistence and possibly to the increase of non-compliant products.

Moreover, national discrepancies in the implementation of the Regulation diminish its effectiveness in achieving a level playing field, inasmuch as they create disparities in the level of enforcement which influence regulatory/administrative costs to businesses across Member States and market behaviour.

The evaluation identified a number of enabling factors, relating to the different national implementations, which made the implementation of the Regulation more or less effective, eventually impacting the achievement of its objectives.

The level of decentralisation of market surveillance structures for instance, impacts the level of existing cooperation and collaboration between national Market surveillance authorities. The more a Member State is decentralised, the more it will need numerous and complex coordination mechanisms.

Resources are certainly a second enabling factor. The lack of resources is considered one of the main bottlenecks to market surveillance implementation and effective deterrence. The different levels of resources have implications on the way Market surveillance authorities perform their tasks. For instance, Market surveillance authorities’ market knowledge in order to target checks is not sufficient in sectors that require specific skills. Moreover, the excessive cost of testing is the most likely explanation for the low level of surveillance, which in some sectors is limited to mere documentary checks. Similarly, resources also influence Market surveillance authorities’ criteria for prioritisation of monitoring and enforcement activities, impacting on the “adequate scale” of controls (foreseen by Article 19 and 24). At the same time, resources influence strategies for market surveillance, which could be proactive rather than reactive.

Powers attributed at the national level and the role of Customs in enforcing the Regulation influence the effectiveness of border control. Controls are indeed expected to be tougher in Member States where Customs act as Market surveillance authorities. Cooperation between Customs and Market surveillance authorities and with other EU Customs are a crucial element for enhancing market surveillance on imported products. In this respect, there are notable differences across Member States.

Overall, it seems that these discrepancies are due to the general nature of the requirements set out in the Regulation. This lack of specificity relates to Member States’ obligations as regards organisation, powers, resources and knowledge necessary to Market surveillance authorities for the proper performance of their tasks. The provision on national reports and programmes is also general, as it does not foresee the transmission of structured information from Member States to the European Commission relating to market surveillance activities, which is particularly evident in light of all the data limitations highlighted in the study. Moreover, the Regulation does not include specific provisions relating to the principles of cooperation between Member States. Finally, the Regulation is not specific enough to set a minimum and/or a maximum level of penalties, or any principles to define them. As discussed, this results in wide differences in the minimum/ maximum amounts within and across Member States, which lowers its power as an enforcement deterrent.

An additional enabling factor identified is the (lack of) cooperation between enforcement authorities and businesses. Among the main reasons for product non-compliance in the internal market is a lack of economic operators’ knowledge on the relevant legislative requirements to be complied with, as well as a deliberate choice to exploit market opportunities at the lowest cost, possibly due to low incentives to comply with the existing rules.

7.2.Efficiency

Most of the costs of the market surveillance provisions are borne by Member States and their market surveillance authorities. Costs incurred by Market surveillance authorities vary considerably from one Member State to another. These differences might be related to different national organisational models requiring different levels of both human and financial resources. However, another possible explanation is the different approach followed by Market surveillance authorities in reporting data concerning the used financial resources as well as the performed activities. Data available suggests that the average annual budgets allocated to MSA activities over the 2010-2013 period do not correlate to the size of the market. The analysis of the efficiency of the Regulation has however been limited by the evident poor quality of data included in the national reports both in terms of completeness and comparability.

The fact that Member States define their own market surveillance approach creates a big variation in the ways the different sectors are controlled and managed. This may also reduce the efficiency of the market surveillance when responsibilities of national authorities are not primarily related to market surveillance of non-food products within the meaning of the Regulation and this creates an overlap and duplication of activities.

With respect to costs for economic operators, information costs caused by the Regulation are perceived as insignificant. On the other hand business stakeholders point to the negative impact that some of the across-the-board inconsistencies in the approach to market surveillance followed by different Member States have on them. They also stress that the current enforcement mechanism is not able to create a level playing field for businesses that are selling products in the Internal Market. This might reduce businesses' willingness to comply with the rules and discriminate businesses that abide by the rules against those who do not.

In terms of benefits there is no evidence of cost savings for businesses as a result of the implementation of the Regulation in terms of administrative tasks or operational tasks if compared to the situation prior to 2008. Furthermore, the expected improved safety for consumers and other product users and level playing field for businesses are not confirmed by RAPEX notifications and by the statistics on the implemented restrictive measures at national level. An increase in RAPEX notifications and surveillance measures may also imply that Market surveillance authorities have become more effective in finding – and thus correcting - non-compliance making products dangerous. However this underlines that the Regulation is still not able to increase businesses' willingness to comply with the rules, thereby discriminating businesses that abide by the rules against those who do not.

Efficiency gains might be achieved by more effective cooperation between industry and authorities. In this way, market surveillance authorities can take advantage of manufacturers’ technical knowledge and may be in a better position to identify non-compliant products on the market and set appropriate priorities for market surveillance activities.

7.3.Relevance

The relevance of the Regulation has been assessed in terms of its scope (including its definitions and concept of lex specialis) and in view of stakeholders’ needs, including those related to new/emerging issues.

The analyses highlighted that a number of stakeholders find the scope of the Regulation not fully clear. Difficulties in understanding the Regulation’s scope might be exacerbated by technological developments introducing new forms of products.

The Regulation’s definitions are generally clear and appropriate, however they are not fully complete and up-to-date, especially when considering the need to cover also online sales.

The Regulation is overall relevant when considering current stakeholders’ needs associated to its general and specific objectives (cooperation and exchange of information, border controls) but it becomes less relevant with looking at needs related to new/emerging dynamics (increasing online trade, budgetary constraints at national level, market dynamics that require a fast reaction). As for online trade, for instance, the Regulation neither includes specific provisions covering online sales, nor does it provide for definitions that account for its specificities. 

7.4.Coherence

Coherence of the Regulation has been evaluated at two levels: internal coherence of the provisions of the Regulation within themselves, and external coherence of the Regulation with the GPSD and sectoral legislations in its scope.

None of the stakeholders reported problems about internal coherence. The Commission could not identify any major internal incoherencies. However, the specification of some provisions currently very general would support more coherence in the implementation of market surveillance.

As for the external coherence some issues have been identified in relation to the GPSD, whose definitions are not always aligned with those of the Regulation. Moreover, the boundary between the GPSD and the Regulation is not always clear. These issues were tackled by the Commission in the legislative proposal put forward in 2013.

Finally, the coherence of the Regulation with sectoral directives is safeguarded to a sufficient extent by the existence of the lex specialis provision. Nonetheless, in certain cases, discrepancies and gaps in the definitions and terminology provided in the different pieces of legislation diminish the overall clarity of the framework for market surveillance, although they do not hinder the implementation of the Regulation. The discrepancies and gaps different sector specific legislations could be addressed when the sector legislation in question is reviewed to align them with the horizontal definitions of Regulation (EC) N° 765/2008.

7.5.EU added value

Overall the benefits of having a single piece of European legislation on harmonising market surveillance instead of several different pieces of national legislation are widely recognised by stakeholders. The harmonisation of rules is seen as contributing to the protection of safety and other public interests underpinning Union product harmonisation legislation, to the establishment of a level playing field and to the improvement in the free movement of goods. The Regulation facilitates transparency and unambiguous interpretation of rules.

The EU added value of the Regulation mainly stems from provisions envisaging common information systems favouring administrative cooperation and enhancing collaboration between customs and Market surveillance authorities.

However, the potential for the Regulation to achieve full EU added value is still hindered by the sub-optimal level of cross-border exchange of information and cooperation, persisting difficulties in dealing with cross-border non-compliance, the lack of uniform implementation of the market surveillance framework at the national level and the insufficient rigour of controls, including imported products.

7.6.REFIT potential

The evaluation identified the following main areas where regulatory burdens could be minimised and rules could be simplified:

·The scope of the market surveillance provisions could become much clearer; a few discrepancies in the definitions and terminology provided in the different sector specific legislations could be addressed when the sector legislation in question is reviewed; 147

·The relation between RAPEX, ICSMS and the safeguard procedures should be improved in order to reduce inconsistencies and confusion, to avoid duplication of work and useless administrative burden 148 . In February 2017 the Commission released the first version of an interconnection between RAPEX and ICSMS. In 2016 safeguard notifications were implemented in ICSMS, with a second release due by end 2017;

·Inconsistencies in the approach followed by Member States authorities while carrying out market surveillance (e.g. interpretation of the concept of appropriate scale of controls, penalties, degree of cross-border cooperation) could be reduced. Coordination mechanisms within Member States should be improved and simplified 149 ;

·The 'market surveillance programmes' and reports on activities carried out could also benefit from simplification and more strategic use 150 ;

·Checks of imported products are still considered insufficient in light of the increasing import from third countries and online sales, especially due to the limited available resources and fragmentation between authorities in different Member States; exchange of information and coordination among the authorities involved could be improved 151 .

(1)      According to Article 15(4), the market surveillance provisions apply to substances, preparations or goods produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction.
(2)      The other elements will be subject to another evaluation at a later stage.
(3)      Commission Communication COM(2015)550 'Upgrading the Single Market: more opportunities for people and business'.
(4)      COM(2016)710.
(5)      SEC(2007)173.
(6)      Recital 1 of the Regulation.
(7)      Recitals 2 and 3 of the Regulation.
(8)      Recital 5 of the Regulation.
(9)       http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32008D0768&locale=en  
(10)      See footnote 21 and section 2 in Annex 4.
(11)      See section 2.1 of Annex 4.
(12)      Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council, COM(2013)75 - 2013/0048 (COD). This proposal was accompanied by a Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC, COM(2013)78 - 2013/0049 (COD)
(13)      i.e. Proposal for a Regulation of the European Parliament and of the Council on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC, COM(2013)78 - 2013/0049 (COD)
(14)       http://www.consilium.europa.eu/en/meetings/compet/2016/05/26-27/  
(15)      Section 2.2.6 of the impact assessment SEC(2007)173 accompanying the legislative proposal for the Regulation; see also point 2.1 of Annex 4.
(16)      Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ L 11, 15.1.2002, p. 4–17.
(17)      Section 2.2.6 of the impact assessment SEC(2007)173 accompanying the legislative proposal
(18)      See section 4 of Annex 4.
(19)      Commission report COM(2013)77 on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
(20)      COM(2014)25 and SWD(2014)23.
(21)      Directive 2009/48/EC on the safety of toys; Directive 2010/35/EU on transportable pressure equipment; Regulation (EU) No 305/2011 laying down harmonised conditions for the marketing of construction products; Directive 2013/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles; Directive 2013/53/EU on recreational craft and personal watercraft and repealing Directive 94/25/EC; Directive 2014/28/EU on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses;    Directive 2014/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels; Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility; Directive 2014/31/EU on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments;    Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments; Directive 2014/33/EU on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts;    Directive 2014/34/EU on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres; Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits; Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC; Directive 2014/68/EU on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment; Directive 2014/90/EU on marine equipment and repealing Council Directive 96/98/EC; Regulation (EU) 2016/424 on cableway installations and repealing Directive 2000/9/EC; Regulation (EU) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC; Regulation (EU) 2016/426 on appliances burning gaseous fuels and repealing Directive 2009/142/EC.
(22)      See section 4.3.1 of Annex 4.
(23)      See section 4.3 of Annex 4. The mitigation measures are set out in section 4.3.3.
(24)      See throughout Annex 4.
(25)      The evaluation only considered sectors where information on the abovementioned indicators was reported by at least 15 Member States, in nine out of 30 sectors. Sectors excluded for which less than 15 Member States report information on the relevant indicators: cosmetics, construction, aerosol, simple pressure vessels, transportable pressure equipment, lifts, cableways, noise emissions for outdoor equipment, equipment and protective systems intended for use in potentially explosive atmospheres, explosives, appliances burning gaseous fuels, electrical equipment under EMC, electrical and electronic equipment under RoHS and WEEE and batteries, chemical, motor vehicles and tyres, recreational craft, marine equipment, non-road mobile machinery, fertilizers, other consumer products under GPSD. Moreover, the group of Member States may vary, depending on the indicator and sector considered.
(26)      For further details, see section 5.2.1 of Annex 4
(27)      See section 6.1.3 of Annex 4.
(28)

     Directive 2000/14/EC on the approximation of the laws of the Member State relating to noise emissions in the environment by equipment for use outdoors.

(29)

     AAMÜ covers the following sectors: equipment and protective systems intended for use in potentially explosive atmospheres, simple pressure vessels, aerosol dispensers, transportable pressure equipment, machinery, lifts, noise emissions for outdoor equipment, electrical appliances and equipment under the Low Voltage Directive (LVD), appliances burning gaseous fuels, personal protective equipment (PPE), toys, recreational craft, other products under GPSD. Source: German Product Safety Act.

(30)

     Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast).

(31)

     Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC.

(32)

     BAuA is a governmental institution with R&D functions that advises the Federal Ministry of Labour and Social Affairs in all matters of safety and health, especially in work-related fields. In consultation with the Federal Ministry of Labour and Social Affairs, the BAuA participates in national, European and international committees for the formulation of regulations and standards. The Federal Institute collaborates with the institutes which operate within its field of work.

(33)

     BAM is a scientific and technical Federal institute under the Federal Ministry for Economic Affairs and Energy. It tests, researches and advises to protect people, the environment and material goods. According to its founding decree, BAM is responsible for the development of safety in technology and chemistry; for the implementation and evaluation of physical and chemical tests of materials and facilities, including the preparation of reference processes and reference materials; for the promotion of knowledge and technology transfer within its areas of work; for advising the Federal Government, industry, and national and international organisations in the fields of material technology and chemistry.

(34)

     UBA is the central environmental authority. It plays an important role in the enforcement of national and European environmental law, for example in the field of industrial chemicals, plant protection products, medicinal products, and washing and cleansing agents. If a risk to human health or the environment exists, it recommends conditions of use, use restrictions or bans. UBA’s specialists also work to improve scientific knowledge about chemicals and their risks, and formulates science-based recommendations for the improvement of environmental and climate protection instruments. It does not only assess environmental health risks to adults and children, but also develops action programmes designed to reconcile environmental and health protection requirements. Its experts also provide advice to municipalities and the Federal States on environmental health issues.

(35)      See section 1 of Annex 8.
(36)      RAPEX (Rapid Exchange of Information System) is an information system between Member States and the EC on measures and actions taken in relation to products posing serious risk to the health and safety of consumers. http://ec.europa.eu‌/‌con‌sum‌e‌rs‌/‌consumers_safety/safety_products/rapex/index_en.htm . RAPEX was established by the GSPD and subsequently extended by Articles 20 and 22 of the Regulation to all harmonised products.
(37)      ICSMS (Information and Communication System for Market Surveillance) is the information and communication system for the pan-European Market Surveillance, referred to in Article 23 of Regulation (EC) No 765/2008.
(38)      http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/reports/index_en.htm
(39)      Section 3.5 of COM(2013)77 provides for an overview of the implementation of ICSMS between 2010-2013.
(40)      No entries are recorded for Malta and Liechtenstein.
(41)      The possibility of objections is set out in sector-specific legislation aligned to the reference provisions of Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC.
(42)      Guidance on cross-border cooperation among EU market surveillance authorities ( http://ec.europa.eu/DocsRoom/documents/17108/attachments/1/translations ).
(43)       See section 1.2 in Annex 8.
(44)      Programmes and reports are available at: http://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation_en
(45)       http://ec.europa.eu/DocsRoom/documents/15241/attachments/1/translations  
(46)     https://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation/administrative-cooperation-groups_en  
(47)      Measuring instruments and non–automatic weighing instruments (WELMEC), low voltage equipment (LVD ADCO), Eco-Design ADCO Group, electromagnetic compatibility (EMC administrative cooperation), civil explosives (CIVEX), machinery, noise emissions by outdoor equipment (NOISE), medical devices (Vigilance Working Group and COEN – Compliance and Enforcement Group), construction products (CPR), PEMSAC (The Platform of European Market Surveillance Authorities for Cosmetics), Toy-ADCO (The Administrative Cooperation Group of toys), recreational craft (RCD), personal protective equipment (PPE), equipment for use in explosive atmospheres (ATEX), Radio and Telecommunications Terminal Equipment (RED), Cableways (CABLE), Energy Labelling and Eco-design (ENERLAB/ECOD), Gas Appliances (GAD), Lifts (LIFT), Marine Equipment (MED), Pressure equipment sector (PED/SVPD), Pyrotechnics (PYROTEC), Chemicals (REACH), Restriction of the use of certain hazardous substances (ROHS), Transportable Pressure Equipment (TPED), Labelling of tyres.
(48)      Most joint actions are indicated under the year during which they were launched, although projects lasted two or more years.
(49)      Joint actions organised in previous periods were: NOMAD Survey of machinery instructions on noise information and noise declarations (original survey work 2007-2012) about 10 Member States participating; Pinspotters/Pinsetters (machines in 10 pin bowling alleys), mostly between 2008 and 2012, about 5 Member States participating; Skid-steer Loaders, 2010-2012, 2-3 Member States; Scissor Lifts, 2010-2012, 5-6 Member States; Wind Turbine access (provision of lifts in towers), 2010-2012, about 4-5 Member States.
(50)       http://www.prosafe.org/about-us/contentall-comcontent-views/what-is-prosafe  
(51)      See section 5.1.1.1 of Annex 4 and Annex 8.
(52)      See section 6.1.1 of Annex 4.
(53)      See section 6.1.1 of Annex 4
(54)      See section 8.5.2 of Annex 4
(55)      See section 6.1.1 of Annex 4.
(56)    See section 1.2 in Annex 8.
(57)      See section 5.3 of Annex 4.
(58)      See for instance point 3 and point 5 in:
http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=23085&no=1
(59)      See section 5.3 of Annex 4.
(60)      See section 6.1.1 of Annex 4.
(61)      See section 8.5.2 of Annex 4.
(62)      Point 2.3.4 of Annex 2.
(63)    See Annex 8.1.5.
(64)     http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=28611&no=1  
(65)      See section 6.1.1 of Annex 4.
(66)      See previous section 5, section 5.2 of Annex 4 and section 2 of Annex 7.
(67)      The analysis in Annex 8 section 3 shows the number of Member States having indicated at least some information on resources available for market surveillance for selected sectors and the simple average of resources reported.
(68)      Not all EU28 Member States provided reliable data for this indicator. Therefore, figures do not include Austria, Cyprus, Estonia, Greece, Croatia, Luxembourg, Slovenia, the United Kingdom and Hungary.
(69)      See section 5.2.1 of Annex 4.
(70)      See section 5.2.1 of Annex 4.
(71)      See section 3 of Annex 7. Regarding the resources dedicated to the enforcement of chemicals which were not included in the previous analysis, market surveillance authorities are generally satisfied with their level of technical resources, while they consider their financial and human resources insufficient or limited, which impedes the achievement of all activities required under REACH (See Annex 8 section 3.2 and http://ec.europa.eu/environment/chemicals/reach/reports_en.htm .)
(72)          Please consider that data for the UK are not available. “Others” includes France.
(73)      The figure about France only captures budget for product testing in state-owned laboratories and therefore underestimates the actual level of resources.
(74)      The analysis includes: BG, CZ, DE, DK, EE, ES, FI, IE, IT, LT, LU, LV, MT, NL, PL, PT, RO, SE, SK; the other MS have not provided complete and reliable data.
(75)      For further details, see section 6.1.1 of Annex 4.
(76)      See section 6.1.1 of Annex 4.
(77)      See section 6.1.1 of Annex 4.
(78)      See section 6.1.1 of Annex 4.
(79)    For instance yearly inspections per 10 000 inhabitants in most Member States having reported information range from 0.5 to 17 for medical devices, from 0.4 to 11 for pressure equipment and simple pressure vessels, from 0.3 to 13 for transportable pressure equipment, from 0.1 to 10 for lifts, etc. – The findings for all sectors and for all member states having providing information can be seen in Section 5 of Annex 7.
(80)      See sections 3.1 and 5 of Annex 7.
(81)    See section 6.1.1 of Annex 4.
(82)      It is considered that the number of enterprises used for the index does not reflect the actual market dimension in the relevant Member State: market surveillance is performed on products, but the relevant manufacturing enterprises do not necessarily have to be based in the same Member State; furthermore, manufacturers may market different types and quantities of products; wholesalers and retailers are also duty holders that can be inspected by authorities but they are not included in the indicator.
(83)      See section 6.1.1 of Annex 4.
(84)      AT, BE, DK, EL, ES, FR, HU, IT, MT, PT, SK are not reported due to lack of data. The height of the bars equals the sum of each of the 33 sectors covered by the Regulation where a given power is granted.
(85)      See section 6.1.1 of Annex 4.
(86)         According to the Blue Guide: “Fulfilment houses represent a new business model generated by e-commerce. Products offered by online operators are generally stored in fulfilment houses located in the EU to guarantee their swift delivery to EU consumers. These entities provide services to other economic operators. They store products and, further to the receipt of orders, they package the products and ship them to customers. Sometimes, they also deal with returns. There is a wide range of operating scenarios for delivering fulfilment services. Some fulfilment houses offer all of the services listed above, while others only cover them partially. Their size and scale also differ, from global operators to micro businesses”. Further and more specific guidance is available in the Online Guidance Notice.
(87)      AT, BE, DK, EL, ES, FR, HU, IT, MT, PT and SK are not reported due to lack of data. The height of the bars equals the sum of each of the 33 sectors covered by the Regulation where a given power is granted.
(88)    See section 4 of Annex 9.
(89)      As confirmed by 83% and 89% of economic operator/civil society representatives (n=15, n=16) - for checks of Market surveillance authorities and checks of Customs respectively – and by 75% of Market surveillance authorities and Customs (n=64). See section 6.1.1 of Annex 4.
(90)      49% consider they were unable to provide estimates or did not reply to the question; however 17%of respondents consider the proportion of imported products to be up to 20%, 15% of them between 21 and 50% and 18% of them beyond 50%.
(91)      15% of respondents believe non-compliance affects most of imported products, 43% some of them, 16% few of them. Only 2% consider imports not affected by non-compliance. 23% did not know or did not reply.
(92)      See chapters 6.1 and 6.2 of the evaluation and sections 6.1 and 6.2 of Annex 4 of the evaluation.
(93)      E.g. Around a third of notified cases through the RAPEX-China system in 2015 was found to be traceable and could be investigated by the Chinese authorities.
(94)    DGTAXUD - Customs and MSA limited Report on customs controls in the field of product safety and compliance in 2015, July 2016 providing partial information on import controls from a selection of Member States. See also Annex 7: in absolute numbers controls are low compared to import volumes and on average 8% of controls are prompted by customs as reported by Member States for the period 2010-2013. Controls are concentrated in 6 product sectors (of 30). Moreover inspection coverage is low in the main entry points to the EU, the sea ports and Rotterdam in particular (Public consultation Position papers; Dutch Court of Auditors, Producten op de Europese markt: CE-markering ontrafeld, January 2017)).
(95)      For further details, see section 6.1 of Annex 4.
(96)      For further details, see section 6.1 of Annex 4.
(97)      See section 5.1 of this report
(98)      The figure compares two qualitative indexes. The “x” axis measures the degree of decentralisation of a national market surveillance structure based on the three models identified: 1=centralised; 2=decentralised at sectoral level; 3=decentralised at local/regional level. The “y” axis measures the degree of cooperation within the single Member State, taking into consideration the cooperation mechanisms/tools described in section 5.2.1. Each cooperation mechanism/tool has been assessed on the basis of three dimensions: the scope of its activities related to market surveillance, its duration over time and its coverage (i.e. in terms of stakeholders’ representativeness). Each of these dimensions has been given a rating from 0 to 1, and the overall value of each mechanism results from the sum of the values of its dimensions. Therefore, a permanent ad hoc body for coordinating market surveillance activities rates 3, since it is permanent (duration=1), it involves all relevant stakeholders (coverage=1) and its scope of activities is the widest (scope=1). A bilateral agreement instead rates 1.1 (coverage=0.1; scope=0.1; duration=0.9). The level of cooperation within a Member State results from the sum of the values of each cooperation mechanism in use therein.
(99)      HU and LT have been not taken into consideration due to lack of data on existing cooperation mechanisms. The correlation between the two variables is quite significant, equal to 0.6760. It is to be noted that the coordination mechanisms used for this graph are those cited in Member States’ national programmes, therefore not all coordination tools actually existing at the national level might have been taken into account. See section 6.1.3 of Annex 4.
(100)      See section 5.3 of Annex 4.
(101)      See section 6.1.2 of Annex 4.
(102)      See section 6.1.2 of Annex 4.
(103)      See section 6.2 of Annex 4.
(104)      For further details, see section 5.2.1 of Annex 4
(105)      See section 6.1.4.
(106)      See section 6.1.1.1.
(107)      For further details, see section 6.2.2 of Annex 4.
(108)      See section 6.2.3 of Annex 4.
(109)    See footnote 82 in section 6.1.2.1.
(110)      See section 6.3 of Annex 4.
(111)      For further details, see the section on coherence.
(112)      See points 3.4 and 3.5 of 'Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016', OJ C 272, 26.7.2016, p. 1.
(113)      See also section 4.2.6, 6.3.1 and 6.3.2 of Annex 4, and box 1 above.
(114)      Commission Notice - The ‘Blue Guide’ on the implementation of EU products rules 2016, OJ C272 of 26 July 2016, p. 1. Further and more specific guidance is available in the Online Guidance Notice.
(115)      See section 5.2.1 of Annex 4.
(116)      See section 6.3 of Annex 4.
(117)      See sections 2.3.4, 2.3.5 and 2.4 of Annex 2.
(118)      Section 4.1.1 of Annex 2.
(119)      For example, http://www.beuc.eu/publications/unsafe-consumer-goods-eu-market-call-stricter-controls/html , https://www.businesseurope.eu/sites/buseur/files/media/position_papers/internal_market/2016-10-31_final_be_sp_enforcement_compliance_in_goods.pdf and http://www.orgalime.org/page/market-surveillance-and-customs-controls . See also the overview of position papers on http://ec.europa.eu/DocsRoom/documents/21663.
(120)      See section 6.3.1 of Annex 4.
(121)      Directive 2009/48/EC on the safety of toys; Directive 2010/35/EU on transportable pressure equipment; Regulation (EU) No 305/2011 laying down harmonised conditions for the marketing of construction products; Directive 2013/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles; Directive 2013/53/EU on recreational craft and personal watercraft and repealing Directive 94/25/EC; Directive 2014/28/EU on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses; Directive 2014/29/EU on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels; Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility; Directive 2014/31/EU on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments; Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments; Directive 2014/33/EU on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts; Directive 2014/34/EU on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres; Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits; Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC; Directive 2014/68/EU on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment; Directive 2014/90/EU on marine equipment and repealing Council Directive 96/98/EC; Regulation (EU) 2016/424 on cableway installations and repealing Directive 2000/9/EC; Regulation (EU) 2016/425 on personal protective equipment and repealing Council Directive 89/686/EEC; Regulation (EU) 2016/426 on appliances burning gaseous fuels and repealing Directive 2009/142/EC.
(122)    Article 12 of Regulation (EC) No 1222/2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters obliges Member State to ensure, in accordance with Regulation (EC) No 765/2008, that the authorities responsible for market surveillance verify compliance with Articles 4, 5 and 6 of the Regulation, relating to the responsibilities of tyre suppliers, tyre distributors, vehicle suppliers and vehicle distributors ; Article 18 of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment obliges Member States to carry out market surveillance in accordance with Articles 15 to 29 of Regulation (EC) No 765/2008; Recital (14) of Regulation (EU) No 1007/2011 on textile fibre names and related labelling and marking of the fibre composition of textile products and repealing Council Directive 73/44/EEC and Directives 96/73/EC and 2008/121/EC indicates that the market surveillance in Member States of products covered by this Regulation is subject to Regulation (EC) No 765/2008 and Directive 2001/95/EC ; Article 65 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products lays down that Member States have to make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of the Regulation, and that Regulation (EC) No 765/2008 applies accordingly ; Article 5(4) of Regulation (EU) No 167/2013 on the approval and market surveillance of agricultural and forestry vehicles and Article 6(4) of Regulation (EU) No 168/2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles specify that Member States should organise and carry out market surveillance and controls of vehicles, systems, components or separate technical units entering the market in accordance with Chapter III of Regulation (EC) No 765/2008. Other provisions of the Regulation oblige economic operators to cooperate with national authorities in accordance with Article 20 of Regulation (EC) No 765/2008; According to recital (12) of Regulation (EU) No 540/2014 of the European Parliament and of the Council of 16 April 2014 on the sound level of motor vehicles and of replacement silencing systems, and amending Directive 2007/46/EC and repealing Directive 70/157/EEC, Chapter III of Regulation (EC) No 765/2008, in accordance with which Member States are required to carry out market surveillance and control products entering the Union market, applies to the products covered by this Regulation.
(123)      See point 5.1 in Annex 5 for a detailed list.
(124)      Articles 27 to 29 refer to Union legislation
(125)      Directive 85/374/EEC concerning liability for defective products; Directive 89/459/EEC on the approximation of the laws of the Member States relating to the tread depth of tyres of certain categories of motor vehicles and their trailers; Directive 91/477/EEC on control of the acquisition and possession of weapons; Directive 2000/53/EC on end-of life vehicles; Regulation (EC) No 273/2004 on drug precursors; Regulation (EC) No 689/2008 concerning the export and import of dangerous chemicals; Regulation (EC) No 1102/2008 on the banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of metallic mercury; Directive 2009/43/EC simplifying terms and conditions of transfers of defence-related products within the Community; Regulation (EU) No 995/2010 laying down the obligations of operators who place timber and timber products on the market; Regulation (EU) No 258/2012 implementing Article 10 of the United Nations’ Protocol against the illicit manufacturing of and trafficking in firearms, their parts and components and ammunition, supplementing the United Nations Convention against Transnational Organised Crime (UN Firearms Protocol), and establishing export authorisation, and import and transit measures for firearms, their parts and components and ammunition; Directive 2014/60/EU on the return of cultural objects unlawfully removed from the territory of a Member State.
(126)      Directive 93/13/EEC on unfair terms in consumer contracts, Directive 98/6/EC on consumer protection in the indication of the prices of products offered to consumers, Directive 1999/44/on certain aspects of the sale of consumer goods and associated guarantees, Directive 2005/29/EC concerning unfair business-to-consumer commercial practices in the internal market, Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2011/83/EU on consumer rights.
(127)       https://whitehall-admin.production.alphagov.co.uk/government/uploads/system/uploads/attachment_data/file/261938/bis-13-1295-product-safety-and-market-surveillance-package-summary-of-responses-2.pdf  
(128)      COM(2013)75 – Proposal for a Regulation of the European Parliament and of the Council on market surveillance of products and amending Council Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC, 2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC, 2009/142/EC, 2011/65/EU, Regulation (EU) No 305/2011, Regulation (EC) No 764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the Council.
(129)      See section 6.3.1 of Annex 4.
(130)      International Law Commission, Study Group on Fragmentation, Koskenniemi, 'Fragmentation of International Law: Topic (a): The function and scope of the lex specialis rule and the question of 'self-contained regimes':An outline', http://legal.un.org/ilc/sessions/55/pdfs/fragmentation_outline.pdf , pp. 3-4.
(131)      Judgment of the Court of Justice of 30 April 2014 in Barclays Bank, C280/13, ECR, EU:C:2014:279, paragraph 44; Judgment of the General Court of 22 April 2016, Italian Republic v European Commission, Case T-60/06 RENV II, ECLI:EU:T:2016:233, paragraph 81.
(132)      Section 5.3 of Annex 4.
(133)      International Law Commission, Study Group on Fragmentation, Koskenniemi, 'Fragmentation of International Law: Topic (a): The function and scope of the lex specialis rule and the question of 'self-contained regimes':An outline', http://legal.un.org/ilc/sessions/55/pdfs/fragmentation_outline.pdf, p.5.
(134)      Section See section 6.3 of Annex 4.
(135)      See section 6.4.1 of Annex 4.
(136)      See section 6.4.2 of Annex 4.
(137)      See also section 6.3.1 of Annex 4.
(138)      Regulation (EC) No 273/2004 on drug precursors applies to two categories of businesses, namely ‘operators’ (i.e. any natural or legal person engaged in the placing on the market of scheduled substances) and ‘users’ (i.e. any natural or legal person other than an operator who possesses a scheduled substance and is engaged in the processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, transformation or any other utilisation of scheduled substances); Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) distinguishes the manufacturer, the importer, the distributor, the producer of an article (i.e. any natural or legal person who makes or assembles within the EU an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition) and the downstream user (i.e. any natural or legal person established within the Union, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities); Similarly, Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures provides also contains obligations for the producers of an article and downstream users; Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators defines economic operators as ‘any producer, distributor, collector, recycler or other treatment operator’; Directive 2013/53/EU on recreational craft and personal watercraft introduced specific obligations for the ‘personal importer’ vis-à-vis the market surveillance authorities; Directive 2014/33/EU on lifts extended the market surveillance obligations to the ‘installers’ of lifts; Directive 2010/30/EU on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products applies to two categories of traders, namely the ‘dealer’ (i.e. a retailer or other person who sells, hires, offers for hire-purchase or displays products to end-users) and the ‘supplier’ (i.e. the manufacturer or its authorised representative in the Union or the importer who places or puts into service the product on the Union market. In their absence, any natural or legal person who places on the market or puts into service products covered by this Directive is considered a supplier); Directive 2010/35/EU on transportable pressure equipment defines the ‘economic operator’ not only as the manufacturer, the authorised representative, the importer and the distributor but also includes ‘the owner or the operator acting in the course of a commercial or public service activity, whether in return for payment or free of charge’. The latter are also subject to the market surveillance obligations laid down in the Directive.
(139)      See section 6.4.2 of Annex 4.
(140)     https://ec.europa.eu/commission/sites/beta-political/files/juncker-political-guidelines-speech_en_0.pdf .
(141)      Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation), OJ L 95, 7.4.2017, p. 1–142.
(142)      COM(2016)283 - Proposal for a Regulation of the European Parliament and of the Council on cooperation between national authorities responsible for the enforcement of consumer protection laws.
(143)      COM(2017)142 - Proposal for a Directive of the European Parliament and of the Council to empower the competition authorities of the Member States to be more effective enforcers and to ensure the proper functioning of the internal market.
(144)

      Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU; the incoming new Regulation on energy efficiency labelling and COM(2016)31 - Proposal for a Regulation of the European Parliament and of the Council on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles.

(145)      See section 6.5 of Annex 4.
(146)      See annexes 2, 6 and 7.
(147)      See chapter 6.4
(148)      See chapters 5.1, 6.1.1 and 6.2.
(149)      See chapters 5.1, 6.1.2 and 6.2. See also reply to EQ3.
(150)      See chapter 6.1.
(151)      See chapters 6.1.3 and 6.3.
Top

Brussels, 19.12.2017

SWD(2017) 469 final

COMMISSION STAFF WORKING DOCUMENT

REFIT EVALUATION

Accompanying the document

Proposal for a Regulation of the European Parliament and of the Council

laying down rules and procedures for compliance with and enforcement of Union harmonisation laying down rules and procedures for compliance with and enforcement of Union harmonisation legislation on products and amending Regulations (EU) No 305/2011, (EU) No 528/2012, (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2017/1369 of the European Parliament and of the Council, and Directives 2004/42/EC, 2009/48/EC, 2010/35/EU, 2013/29/EU, 2013/53/EU, 2014/28/EU, 2014/29/EU, 2014/30/EU, 2014/31/EU, 2014/32/EU, 2014/33/EU, 2014/34/EU, 2014/35/EU, 2014/53/EU, 2014/68/EU and 2014/90/EU of the European Parliament and of the Council

{COM(2017) 795 final}
{SWD(2017) 466 final}
{SWD(2017) 467 final}
{SWD(2017) 468 final}
{SWD(2017) 470 final}


Annex 1: Procedural information

1.    Identification

·Lead DG: DG Internal Market, Industry, Entrepreneurship and SMEs (GROWTH)

·Agenda planning/Work programme references: 2017/GROW/007

2.        Organisation and timing

Work started in January 2016. An Inter-Service Steering Group (ISSG) chaired by DG Internal Market, Industry, Entrepreneurship and SMEs (GROWTH) was established to this purpose. Its members included representatives of:

·Secretariat-General

·DG Climate Action (CLIMA)

·DG Economic and Financial Affairs (ECFIN)

·DG Employment, Social Affairs and Inclusion (EMPL)

·DG Energy (ENER)

·DG Environment (ENV)

·DG Justice and Consumers (JUST)

·DG For Mobility and Transport (MOVE)

·DG Health and Food Safety (SANTE)

·DG Taxation and Customs Union (TAXUD)

·DG Trade (TRADE)

The ISSG met in total nine times (29/01/2016, 07/03/2016, 21/04/2016, 29/09/2016, 28/11/2016, 27/01/2017, 10/02/2017, 27/02/2017 and 06/03/2017).

3.    Consultation of the Regulatory Scrutiny Board

The Regulatory Scrutiny Board (RSB) of the European Commission assessed a draft version of the present evaluation and issued its opinion on 07/04/2017. The Board made several recommendations. Those were addressed in the revised report as follows:

RSB recommendations

Modification of the report

(B) Main considerations

The Board acknowledges a significant effort to collect evidence on non-compliant products as part of the evaluation work.

However, the Board considers that the report contains important shortcomings that need to be addressed, particularly with respect to the following issues:

(1) The evaluation report is not a self-standing document.

(2) The evaluation fails to deliver evidence-based findings and conclusions.

Against this background, the Board gives a negative opinion and considers that in its present form this report does not provide sufficient input for the associated Impact Assessment.

See below

(C) Further considerations and adjustment requirements

(1) Self-standing evaluation report

The evaluation report should be a self-standing document.

The SWD and the annexes were fundamentally redrafted so that the evaluation became a self-standing document.

It should include the main findings of the underlying external evaluation study and other available evidence, which are now in the annexes.

Done in section 4, 5.1, 6 and 7 of the SWD.

The report should present evidence in a structured way, following a clear intervention logic and addressing all the evaluation criteria.

New intervention logic in section 2.1.1. All evaluation criteria are examined separately in section 6 of the SWD (except EQ2/EQ3 and EQ8/EQ9 which are examined jointly for the sake of clarity)

The report should be clear about limitations of what the available evidence can reasonably demonstrate.

Done in section 4 of the SWD as a summary of the limitations set out in Annex 4.

As a REFIT exercise, the evaluation should also assess the scope for simplification and reduction of regulatory burden.

Done in section 7.6 of the SWD.

(2) Scope

The report should more clearly present the scope and limitations of the evaluation.

Scope and limitations explained in section 2.1.2 of the SWD

It should provide an explanation of the existing legislative framework and how the provisions are implemented in Member States.

Explained in 2.1.2, 2.1.3 and 2.3.1, and in detail in Annex 5.

The report should draw conclusions from the diversity of national practices.

Done mainly in section 6.1 but it is a recurrent feature throughout the text.

It should substantiate the fact that penalties are not high enough. It should explain the links with sectoral legislation and how mutual recognition and customs policy work together.

The penalties are examined in sections 6.1.2.2, 6.1.2.1, 6.1.3 and under EQ3, and in several other places of the text, and in greater detail on pp. 105-108 of Annex 4. Links with sector legislation explained in section 2.1.3 and table 1 of the SWD, and in Annex 5. Border controls explained in more detail essentially in section 6.1.3 of the SWD, under EQ3, and section 2 of Annex 8.

Against this background, it should clarify the scope and benchmarks used for the evaluation.

Done in section 2.1 of the SWD

It should add relevant information from previous impact assessments and evaluations

Full list in section 8.14 of Annex 4.

(3) Conclusion

The report should align its conclusions with the revisions required for the other sections. They should clearly set out main lessons learned and how far evidence supports them. As such, the conclusions should provide a solid basis for the scope and problem definition of the parallel impact assessment for future policy developments in the area.

Done in section 7 of the SWD.

The Regulatory Scrutiny Board (RSB) of the European Commission assessed the revised version of the present evaluation and issued a positive opinion on 31/05/2017. The Board made few final recommendations that were addressed in the revised evaluation as follows:

RSB recommendations

Modification of the report

(B) Main considerations / (C) Further considerations

(1) Further elaboration if the REFIT dimension throughout the evaluation.

The relevant aspects were consistently referred to in the sections on effectiveness and efficiency. The reasons why regulatory burden reduction concerns mainly authorities are explained.

(2) Additional explanations on how market surveillance works in practice in a Member States.

A detailed overview on the organisation of market surveillance in two Member States was added.

(3) Reader friendliness.

The introduction in particular is now a bit less technical and includes a summary of main findings.


Annex 2: Stakeholder consultation

1.    Objectives Of The Consultation 

The Commission wanted to make an evidence-based assessment of the extent to which the provisions on market surveillance of Regulation (EC) No 765/2008 have been effective, efficient, relevant, coherent and achieved EU added-value. The results of the evaluation will support taking actions to enhance efforts to fight non-compliant products made available in the Single Market.

1.1    Consultation methods and tools

The market surveillance authorities have been consulted during the meetings of the Expert Group on the Internal Market for Products in 2016 .

A stakeholder conference - open to all interested participants - was organised by the Commission on 17 June 2016.

A public consultation in all EU official languages, published on a website hosted on Europa, run from 1 July to 31 October 2016. Participation of SMEs in the consultation was promoted and supported through the European Enterprise Network.

2.    Results Of The Consultation Activities

2.1    Meetings of the Expert Group on the Internal Market for Products – Market Surveillance Group

The Expert Group on the Internal Market for Products – Market Surveillance Group held its last meetings on 1st February 2016, 21st October 2016 and 31st March 2017.

During the first meeting, the Commission recalled the challenges reported by market surveillance authorities in the national reviews and assessment of activities carried out between 2010 and 2013. The detailed IMP document is annexed to the Impact Assessment (Annex 2).

During the meeting held on 21 October 2016, the Commission informed the participants of the state of play of the enforcement and compliance initiative and explained that the purpose was to receive feedback on the suitability of the ideas under examination. The detailed minutes can be found at: http://ec.europa.eu/transparency/regexpert/index.cfm?do= groupDetail.groupDetailDoc&id=28611 .

The meeting held on 31 March 2017 focused on the legislative proposal and especially on how to enhance cooperation between the member states, create a uniform and sufficient level of market surveillance and have stronger border controls of imported products to the European market.

2.2    Meetings of the Customs Expert Group 

The Customs Expert Group that met on 22 April was informed about the launch of the Enforcement and Compliance initiative. Customs authorities were invited to participate in the consultations and provide their views on possible challenges and actions needed.

The Expert Group PARCS met to discuss product safety and compliance controls on 1 December 2016. At the meeting the Commission presented the state of play on the revision of Regulation (EC) No 765/2008.

2.3    Stakeholder conference of 17 June 2016

A stakeholders' event was organised on 17 June 2016, to identify the main issues related to the compliance and better enforcement in the Single Market and to identify possible ways forward. 144 participants attended the event, representing businesses (62), national authorities (60) and others (22). The detailed minutes of this conference can be found at: http://ec.europa.eu/DocsRoom/documents/17963 .

2.4    Public Consultation

239 replies were received via the online form foreseen during the public consultation. The numbers and percentages used to describe the distribution of the responses to the public consultation derive from the answers under the EU-Survey tool. Other submissions of stakeholders to the public consultation have been taken into account, but without being considered for the statistical representation.

The consultation was divided into five parts. Since only part B1 was obligatory, the other sections were partly answered. Therefore, the average ratio of replies was 80% for section B2, 66% for section B3, 80% for section B4 and 84% for section B5.

All statistics included in this summary are based on the data gathered from the replies for each section. Detailed statistics for each category can be found in Annex 2 of the Impact Assessment.

Businesses were strongly represented (127), followed by public authorities (80), and citizens (32). More specifically for businesses, 49% of them represent product manufacturers, 21% product importer / distributors, 8% product users, 5% conformity assessment bodies, 1% online intermediaries and 16% other.

Concerning the geographical distribution of responses, all countries were represented except for Latvia, Luxembourg, Malta, and Liechtenstein. The majority of respondents (116) exert their activities only in their country of establishment.

2.4.1    Product compliance in the Single Market and deterrence of existing enforcement mechanisms

The majority of respondents (89%) consider that their products are affected by non-compliance with product requirements laid down in EU harmonisation legislation.

However, 45% of the respondents are unable to estimate the approximate proportion of non-compliant products for their sector. This percentage is approximately equal for all type of respondents.

80% of businesses participating in the consultation confirm non-compliance has a negative effect on sales and/or market shares of businesses complying with legal obligations. Many businesses (42%), however, are unable to estimate their approximate loss in sales due to non-compliance.

As to the most important reason for product compliance in the Single Market, 33.47% of the respondents consider that it is about a deliberate choice to exploit market opportunities at the lowest cost, followed by a lack of knowledge (26.78%), a technical or other type of inability to comply with the rules (10.88%), ambiguity in the rules (10.46%) and carelessness (9.62%).

All types of respondents have experience / knowledge of instances where market surveillance authorities lacked sufficient financial and human resources as well as the technical means to carry out specific tasks. Nevertheless, 67.36% of the respondents could not estimate the approximate financial resource gap of the national authority.

Regarding the increase of resources for market surveillance activities, although two of the three solutions receive a unanimous acceptance by the respondents, for the third one, namely that market surveillance authorities should levy administrative fees on operators in their sector to finance controls, the results are contradictory. 55.91% of the businesses and 40.63% of the consumers and others strongly disagree with this option, while 50.00% of the public authorities agree with it (15% strongly agree and 35% agree).

Stakeholders have similar views as regards the effective use of resources for market surveillance activities.

Many respondents (46%) agree that market surveillance does not provide sufficient deterrence in their sector or that it provides deterrence to a moderate extent (34%) and that the options proposed by the Commission would improve the deterrence of market surveillance action.

2.4.2    Compliance assistance in Member States and at EU level

This section of the questionnaire was optional, so the average ratio of replies came up to 80% (approximately 190 replies per question).

There is a consensus on the fact that sometimes it is difficult to find but also understand the correct information on the technical rules that products need to meet before they can be placed on the domestic and on other EU markets.

The approach taken by respondents to look for support and information on technical rules that products need to meet slightly differs according to the type of respondent. The majority of respondents prefer to refer to the information available on Commission websites. Regarding the approaches that should be followed by national authorities to reduce the level of non-compliant products on the market, the respondents consider that the best approach is the combination of information, support and enforcement by the public authorities.

2.4.3    Business' demonstration of product compliance

This section of the questionnaire was optional, so the average ratio of replies came up to 66% (approximately 158 replies per question).

Businesses were asked to provide answers on how they supply information about product compliance. Approximately 30% of the respondents consider that the proposed options are not applicable to them.

A large majority of respondents strongly agrees or agrees that a broader use of electronic means to demonstrate compliance would help to reduce the administrative burden for businesses (70.62%), reduce administrative costs of enforcement for authorities (65.14%), provide/allow information to be obtained faster (82.29%), and provide more and up-to-date information to consumers/end users (68.00%).

2.4.4    Cross-border market surveillance within the EU

This section of the questionnaire was optional, so the average ratio of replies came up to 80% (approximately 190 replies per question).

Most of the respondents (91) were unable to estimate the approximate proportion of products placed on the market by manufacturers or EU importers located in another EU Member State.

Public authorities believe that businesses contacted do not reply to requests for information/documentation or for corrective actions, while for businesses the main difficulty is that authorities find it more costly to contact businesses located in another EU Member State.

Concerning, the exchange of communication between national authorities in the EU Member States, the majority of respondents stated lack of opinion / experience (33%) while 25% of the respondents consider that national authorities rarely restrict the marketing of a product following exchange of information about measures adopted by another authority in the EU against the same product.

Additionally, as to the adequate mechanisms to increase the effectiveness of the market surveillance in the Single Market, the results showed an extremely large support for more exchange of information and discussion among authorities, but also for close coordination between Member States and simultaneous applicability of decisions against non-compliant products.

2.4.5    Market surveillance of products imported from non-EU countries

This section of the questionnaire was optional, so the average ratio of replies came up to 84% (approximately 201 replies per question).

Many respondents (39%) were unable to estimate the approximate proportion of products imported from non-EU countries in their sector. However, 21% of them indicated that the proportion of products imported from non-EU countries is more than 50%. At the same time, 88% of the respondents believe that the products in their sector imported from non-EU countries are affected by non-compliance.

As to the country of origin of often non-compliant imported products, China lead with 137 replies, followed by India (30), Turkey and United States (18) and Hong Kong (17). Finally, the most preferred options in taking actions against non-compliant products traded by businesses located in a non-EU country were the need for more coordination of controls of products entering the EU between customs and market surveillance authorities (88.27%).

2.5    Targeted Consultation conducted by the Contractor

In general, all stakeholders consulted through the targeted surveys and interviews uniformly recognise the effectiveness of the Regulation needs to be improved. 1 Around half respondents declare that the dimension of product non-compliance has not changed after the entry into force of the Regulation. While this is true for public authorities, respondents from the private sector perceive that product non-compliance has increased. Most economic operators, industry associations and civil society representatives state to experience discrepancies across Member States in terms of market surveillance. Such discrepancies have more negative impacts in terms of hindering the free circulation of goods, influencing market behaviour, reducing the safety of products and raising costs for public authorities and economic operators to comply with the Regulation. Among all respondents, only customs have a positive opinion on the adequacy of current border controls. In general, industry representatives want to be more involved in market surveillance activities. According to respondents, the efficiency of the Regulation could be improved by solving the existing discrepancies in its implementation.

The majority of respondents confirm the Regulation’s relevance, this being confirmed by all economic operators and a large part of customs and coordinating authorities. However, the Regulation’s relevance can be challenged by its low capacity to address emerging issues. All stakeholders agree that the Regulation is not able to tackle issues deriving from online sales. No stakeholder category reported major issues in term of coherence of the Regulation, both within its provisions and with other legislations relevant for market surveillance.

All stakeholders recognise the EU added value of the Regulation, which enhanced the free movement of goods and legislative transparency. The harmonisation of rules and cooperation between Member States are also reported as benefits by all. Different categories also argued that the Regulation can establish a level playing field across businesses in the EU.

2.6    Informal consultation of SMEs at the Small Business Act follow-up meeting with stakeholders in December 2016

The Commission presented the reflections on the possible options to address the problem of non-compliance and asked for feedback. Businesses representatives confirmed that SMEs are also hit by non-compliance like bigger companies.

3.    FEEDBACK TO STAKEHOLDERS

The consultation processes provided a wide range of views regarding the functioning of market surveillance in terms of what has worked well and what has not worked so well, seen through the eyes of these stakeholders. The meetings with the stakeholders provided an early opportunity to promote the engagement of the national authorities, thus enhancing the chances of a good response rate.

The general objective of this initiative is to reduce the number of non-compliant products in the Single Market by improving at the same time incentives to comply and effectiveness of market surveillance..

The considered options covered in order of increasing ambition and EU coordination and action: (1) Baseline, (2) Improvement of existing tools and cooperation mechanisms; (3) in addition increased deterrence effect to enforcement tools and stepped up EU coordination and (4) further added-on centralised EU level enforcement in certain cases.

The preferred option (3) includes:

the extension of Product Contact Points advice role to businesses and ad-hoc public-private partnerships;

digital systems through which manufacturers or importers would make compliance information available to both consumers and market surveillance authorities and common European portal for voluntary measures;

regime of publicity for decisions to restrict the marketing of products, fine-tuning authorities powers notably in relation to on-line sales imports from third countries, recovery of costs of controls for products found to be non-compliant;

stricter obligations for mutual assistance and legal presumption that products found to be noncompliant in Member State A are also non-compliant in Member State B;

Member States' enforcement strategies setting out national control activities and capacity building needs and an EU Product Compliance Network providing an administrative support structure to peer review Member States' performance coordinate and help implementing joint enforcement activities of Member States.

The measures underlying the preferred option were rated highly favourable across the different categories of respondents in the public consultation. Stakeholders concur on the need for much stronger coordination, more resources and efficient use of resources for market surveillance and more effective tools to improve the enforcement framework for controls within the Single Market and on imports into the EU. A more pro-active approach to prevent non-compliance by providing information and assistance to economic operators is also supported by stakeholders. On a more detailed level some variations occur between the views of authorities and businesses on the most appropriate form of the digital compliance system or the specific powers and sanctions; these concerns have been integrated in the assessment.

More information on the different options, on those retained and on the views of the stakeholders can be found in Sections 6 and 7 of the Impact Assessment.

4.    Feedback From the Expert Group on the Internal Market for Products – Market Surveillance and Conformity Assessment Policy (IMP-MSG)

4.1    Difficulties and challenges for market surveillance for non-food products in the Single Market

4.1.1    Contributions sent to the Commission in accordance with Article 18(6) of Regulation (EC) No 765/2008

Article 18(6) of Regulation (EC) No 765/2008 requires Member States to periodically review and assess the functioning of their market surveillance activities. Such reviews are to be carried out at least every four years and the results are to be communicated to the other Member States and the Commission and made available to the public.

Many of the national reports reviewing market surveillance activities carried out between 2010 and 2013 comment on major difficulties identified. Common challenges mentioned appear to be the following:

1.Lack of sufficient resources for market surveillance.

2.Current control procedures are not suitable for handling products sold online. Moreover, for effective market surveillance of products sold on the internet and that are offered from outside the EU, collaboration with customs authorities is of crucial importance.

3.There is a need to reinforce customs controls. Furthermore, to make it harder for non-European manufacturers, whose non-compliant products have been rejected by a customs authority, to switch to other customs clearance locations, improved cooperation between the customs authorities of the EU Member States also seems necessary. For some Member States there exists a mismatch between the customs product classification and the nomenclature used by market surveillance authorities, which hamper cooperation in some areas (e.g. electrical low voltage equipment, personal protective equipment, pressure equipment, equipment for use in potentially explosive atmospheres, lifts and machinery).

4.There is insufficient cross-border cooperation in some sectors (i.e. equipment for use in potentially explosive atmospheres, pyrotechnic articles, civil explosives and gas appliances), which is difficult to tackle when relevant economic operators are located abroad. Complications due to the lack of ADCOs for marine equipment and motor vehicles are also mentioned.

5.There is a lack of traceability of information especially when products are imported into the EU by intermediaries located in other Member States

6.There is the difficulty of dealing with products from third countries sold via informal channels (marketplaces), and the ineffectiveness of market surveillance techniques in this case.

7.Penalties laid down in national law might not be a sufficient deterrent, in particular in the case of larger companies trying to market non-compliant products;

8.The non-existence of test laboratories makes conformity assessment difficult and costly.

9.There is a lack of knowledge amongst economic operators about applicable product rules. In some sectors formal requirements such as technical documentation and CE marking are disregarded by businesses, possibly due to lack of knowledge or misunderstanding of those requirements.

10.There is a lack of cooperation by certain economic operators and some abuses by businesses of the legal principles concerning the notification of restrictive measures contained in Article 21 (1) and (2) of Regulation (EC) 765/2008.

11.There is the need to reduce the administrative burden for market surveillance authorities (i.e. simplify current safeguard clause procedures for serious risk products by using the Rapex system). Furthermore, there is a demand for a single integrated system since reporting in different information exchange systems is deemed cumbersome and not always suitable.

4.1.2    Future new actions to improve market surveillance – initial suggestions by Member States 

At the latest joint IMP-MSG and CSN meeting on 30 January 2015 the Commission asked Member States representatives to come up with informal suggestions about possible future new actions to improve market surveillance. A Member State suggested that a possible way to increase the availability of resources for market surveillance would be to ensure EU-wide agreements (financed by EU funds), with laboratories having recognised competence in a given domain to which national authorities could send on a pro-rata basis products to be tested.

The question about possible new actions to improve market surveillance was also asked at the last meeting of ADCO Chairs that took place on 12 March 2015. Some of the suggested new actions informally proposed during that meeting were the following:

1.Workshops with other ADCO Groups

2.Cooperation between inspectors checking products during use and market surveillance

3.Cooperation with producer countries, especially China

4.Supervision of notified bodies and collaboration with market surveillance authorities

5.More documents to be shared through CIRCA BC

6.Joint actions between directives

7.Feedback on safeguard notifications from the Commission

8.Shorter dates between publication of legislation and guidance

9.Exchange between inspectors across Member States

10.Easier contacts with economic operators abroad

11.Team building, networking, exchange of experience

12.More information on what is happening in other fields

13.Review of notified bodies' certificates

14.Exchange of ADCO members

15.Convergence of ICSMS and RAPEX platforms

16.E-commerce: administrative requirements for information to be displayed on websites, legal powers for authorities to carry out test purchases, campaign aimed at consumers

17.More responsibilities for importers

18.More resources

19.Applicability across the EU of sale bans issued by national authorities.

4.2    Questions to the Members of the IMP-MSG Group and overview of replies

On 2 December the members of the IMP-MSG group were invited to provide input on the following questions:

(1)Do you share the analysis of the problem of non-compliant products in the internal market made by the Commission in the Single Market Strategy? Is there any other relevant problem to take into account?

(2)What action do you consider necessary to tackle those problems?

(3)What action is necessary to address the difficulties faced by national authorities that have emerged in the context of the national reviews according to Article 18(6) of Regulation (EC) 765/2008?

(4)What should be the main priorities when it comes to improving market surveillance and to generally reducing non-compliance in the internal market?

Thirteen Member States provided answers to the above questions.

As to question (1) most of these Member States share the analysis carried by the Commission. The following additional qualifications are noted:

A Member State also stresses the problems of (i) several pieces of legislation applicable to the same product which makes it more complex and difficult for both economic operators and authorities to maintain the overall picture, (ii) uneven quality and quantity of market surveillance activities in different Member States, which could be addressed by establishing common standards, (iii) limited availability of resources.

Another one notes that the problem of non-compliance is to be addressed to ensure a level playing field among economic operators, although accidents due to non-compliance are limited in number overall.

Furthermore, there is no solid proof that the number of non-compliant products is increasing, as statistics on market surveillance differ from statistics on non-compliance that could result from market research.

Similarly, two other Member States note that since market surveillance inspectors focus on areas where non-compliance is expected to be high, results of inspections are not representative of the level of non-compliance in general. Denmark stresses that it is not possible to measure the percentage of non-compliant products in the market.

Some questions exclusive focus on the non-compliance of products stating that market surveillance should also play a role to ensure that legitimate products do not face unfair barriers to trade.

Finally, another Member State would have appreciated a deeper analysis of if, when and in what ways the impact of varying degrees of market surveillance (or the lack of it) harm consumers, compliant competitors, and Member States as a whole (loss of manufacturing, reduced competitiveness, etc.). Such an analysis could indeed give valuable input regarding when and where a lack of enforcement has the least impact on the different interests that a product rule is designed to protect, which in turn could be used in subsequent Refit procedures with a view to reducing the administrative burden.

The suggestions made by the Member States who responded to questions (2) to (4) have been grouped as far as possible by topics as follows:

4.2.1    Information to economic operators 

The lack of knowledge of product rules on the part of economic operators is one of the main problems that should be addressed.

Informing the national economic operators – who are sometimes not aware of their responsibilities - about specific legislation and their obligations, is a main priority.

Economic operators probably disregard the rules mainly because of a lack of knowledge, or because they lack the resources to follow up the complicated rules on their own (SMEs).

There is a need to intensify efforts to provide early information to economic operators, especially small and medium-sized enterprises, on existing and future product legal requirements but also to raise awareness amongst economic operators via better channels of communication.

It is also suggested developing rules and best practices concerning products to be disseminated via internet and improving information on European regulations on the websites of the Commission to make it more educational and useful for economic operators (input by product type, not directive).

If the problem which has been identified is referring to economic operators “in general” the solution has to be Commission-led. This might be done, for example, by revisiting the guidance and how it is made available to them, making changes where appropriate. However, if this refers to specific economic operators the approach also has to be specific, and it is more likely to fall to individual Market Surveillance Authorities and Member States to determine the action which should be taken.

In addition, the Commission does not have sufficient manpower to handle a 'first port of call' to address businesses' questions on all areas of product legislation, which would require a huge amount of work. An eLearning system is proposed for raising awareness and educating economic operators through graphic interfaces, and access to applicable standards and conformity assessment procedures, and a "10-20 questions card" for importers to ask when they buy goods overseas.

4.2.2    Simplification of product legislation; alignment between legal requirements and verification procedures by MSAs

Legislation should set out economic operators' obligations more clearly and it should be possible to make a clear distinction between basic non-compliance and more serious safety issues. Legislation needs to be simplified and updated.

As regards future legislation, there is a suggestion reflecting on how to include the necessary new rules in existing legal acts rather than developing new (unknown) specifications but also to better take into account the concerns of market surveillance authorities during the legislative process: the feasibility of checking specific requirements and the foreseeable costs of those requirements should be assessed in the development stages of legislation.

The weakness of verification procedures in some sectoral legislation is also pointed out. Even when a Member State performs verification tests, the results of these tests may turn out to be inconclusive, because of the unreliability of the results when the tests are replicated, and/or because of ambiguities in dealing with those results. A comprehensive “fitness check” on verification procedures based on established best practice would be useful. For example: a wet-grip-in-tyre labelling regulation where the test method seems to be unsuitable to providing sufficient accuracy (actually the 2sigma-interval of reproducibility uncertainty covers 3 grading classes). Technical requirements for verification of big products at the manufacturers site, for instance by means of witness-testing during factory acceptance tests, should also be definitively introduced.

4.2.3    Coordination of market surveillance at EU level 

The need for closer cooperation and exchange of information is generally acknowledged. Specific proposals are made with respect to the use of current tools or to the need for additional forms of cooperation.

4.2.3.1    ICSMS and RAPEX

The importance of the development of the ICSMS and RAPEX systems for communication between all authorities involved in market surveillance (market surveillance authorities of all Member States, COM and, where appropriate, customs authorities) is stressed. ICSMS should be used consistently by Member States in all areas of legislation while interfaces with national systems should be provided. The creation of single system for exchange of information has also been requested but also the idea of fusion between ICSMS and RAPEX platforms to avoid the double encoding of data; however, this should take into account the fact that the RAPEX system has been used for a long time by all stakeholders.

The focus of the Commission’s wording on the Single Market Strategy is on working better together, with better sharing of information. In this regard Member States could make better and more consistent use of ICSMS; they recognise that this is a medium- to long-term issue, and one which might require funding/support from the Commission in order to make it work – in particular for those Member States who do not use the system.

There is a need for closer cooperation between surveillance authorities in Member States and between surveillance and custom authorities, and between surveillance authorities and notified bodies, and suggests it would be good to have a stronger convergence between the the ICSMS and RAPEX platforms.

4.2.3.2    ADCOS and IMP-MSG groups

The role of ADCOs should be revisited and clarified (many discuss policy issues rather than focussing on issues related to technical cooperation, for example), and absences from meetings/participation should be marked. The Commission desk officers for the relevant directives should also take a stronger role in encouraging attendance/participation. Furthermore, the European Market Surveillance Forum, which was proposed in the “Regulation on Market Surveillance”, would be a positive way of addressing this issue.

Member States welcome the proposal mentioned in section 3.2 above relating to workshops with other ADCOs. Similarly, a Member State suggests a better use of ADCOs to improve coordination, exploit synergies and avoid duplication. Furthermore, it suggests that the IMP-group should develop a shared understanding of the horizontal rules and promote more interaction between the market surveillance authorities of the Member States in the different fields of law by means of visits, joint actions, etc.

There is also a proposal devoting an extra IMP-MSG meeting to the exchange of best practice. ADCOs should contribute to the meeting by reporting on experience accumulated during their earlier joint action projects.

4.2.3.3    Cross-border cooperation

The need for consistent implementation of the guidelines on cross-border–cooperation is stressed, complemented if necessary by the set-up of additional legal arrangements. Furthermore, under the safeguard clause procedure all European market surveillance authorities must take, where necessary, measures to enforce requirements under European law. Furthermore, a Member State suggests that where a public authority prohibits the making available on the national market, this should automatically apply in all MS, with the ECJ possibly acting as appeal. Member States should reflect on the possibility of specialising in specific fields. In order to achieve an effective market surveillance system, the adaptation of national legislation to the EU legislation will be necessary in a number of areas (cross-border cooperation, mutual recognition of activities of the market surveillance authorities of other Member States - for example, recognition of test reports, etc.). The organisation of market surveillance at national level should be reconsidered in order to reduce the fragmentation of responsibilities.

There is also a need for guidance on cross-border cooperation to improve and optimize the results of authorities’ actions. To achieve better results in trans-border cooperation between the Member States, in cases of non–compliant products a contact points list for each product group should be prepared which could provide fast and easily accessible communication.

A mandatory harmonized procedure for MSA cooperation will facilitate cases of cross-border cooperation and will further harmonize existing market surveillance approaches. The administrative burden for MSAs of this procedure should nevertheless be as minimal as possible.

Prior to setting additional requirements for mutual change of information, the Commission should ensure that all Member States actively use the present procedures and notes that for example EMC and LVD notifications are made by only a few States.

It would be useful for Member States to receive more feedback on safeguard notifications. In general, more cooperation and exchange of information is needed at EU and national level.

'Language borders' are considered as the main obstacle to day-to-day cooperation among authorities.

4.2.4    Harmonisation of market surveillance practice across Member States

There is a suggestion developing common European standards on the quality and quantity of their market surveillance activities.

The development and publication of guidelines and best practices on market surveillance in general is welcomed as a means to achieve the consolidation of the procedures of the EU market surveillance authorities in many problematic areas.

Publication of guidance documents would considerably help the harmonization of market surveillance in Europe as they would help inspectors and economic operators to interpret and correctly apply the directives and regulations. Shorter dates for the publication of guidance documents are required.

In addition, it is proposed to encourage via EU funding the participation of more Member States in common projects in which different products can be tested in order to achieve more representative results, and the dissemination of all information, analysis, results and decisions taken for this specific product group after a project is completed.

According to feedback from domestic surveillance authorities having taken part in international cooperation projects, they have provided a good overview of the practices of other countries and have contributed to carrying out uniform surveillance in different Member States.

The problem of limited human resources and training opportunities has been pointed out and a suggestion was made to promote the exchange of inspectors across Member States and closer cooperation among surveillance authorities to improve knowledge and exchange experiences.

Training programmes and exchange of experience between Member States' inspectors are also proposed.

The exchange of experience and best practices between inspectors across the Members States is very important to improve the harmonization of market surveillance in Europe. Regular exchanges of officials could be a solution.

Similarly, exchange of inspectors, teambuilding and networking are endorsed by other Member States.

Moreover, the Product Safety & Market Surveillance Package has to be finalized, since it will enable better coherence of the rules regulating consumer products and will improve coordination of the way authorities check products and enforce product safety rules across the European Union.

The current delay with revision of the Market Surveillance Regulation is considered to be problematical, and stresses the importance of a horizontal legislative framework on market surveillance.

The Commission should provide more information on what instruments are available to the authorities and how they are used in practice (frequency, criteria for deciding what tools to use in different cases), so that the barriers for putting non-compliant products on the market might be the same for all Member States.

4.2.5    Better control of products imported from third countries

There is a need to strengthen border controls, where the goods are centralised before being dispatched throughout the EU. This could be achieved either by reinforcing the role of customs or by ensuring detailed cooperation with market surveillance authorities.

More effective cooperation between market surveillance and customs authorities should also be achieved via a clearer definition/better alignment of the tasks performed by the customs authorities in order to ensure compliance with the European product rules. The need for improved communication between the customs and market surveillance authorities is also stressed.

Controls would improve if there was better communication between authorities. This might potentially be done through an electronic forum which authorities could use to discuss and agree issues which arise on products, and better guidance on the application of the directives concerned and the procedures which need to be followed.

Both the importance of cooperation between customs and market surveillance authorities and the importance of cooperation among customs on market surveillance matters are mentioned.

Customs should be enabled to request manufacturer and type designation as part of the customs declaration. Furthermore, combined nomenclature (CN) codes must be amended to be also useful for market surveillance purposes.

There is a need to improve border control of non–compliant products and to ensure regular exchange of information on results of controls and lists of products not released for free circulation.

Another problem is that, while many products come from outside the EU, authorities can do little against those manufacturers. Products are often placed on the EU market through “once only importers” that disappear after one or two years, so even there we can do little. Strong measures against these products are needed to target the non EU economic operator. For example, a strong message could be sent when all products need to be recalled if there is no technical file present.

A Member State supports the strengthening of responsibilities of importers, especially when the manufacturer is outside the EU. For the supervisory authorities it is especially helpful to have a partner in the EU, which has full responsibility and all the technical documentation. According to France this could possibly be done by creating a concept of "first placer on the market", which would need to be an economic operator on the EU territory (manufacturer, agent or importer if the manufacturer outside the EU).

Improving the opportunities for the European market surveillance authorities to impose penalties on operators in third countries by means of agreements between the EU and third countries was also pointed out. It was also proposed to have a sustainable education strategy on the existing European rules in third countries that export mainly to Europe but also some guidelines on how to deal with different types of non-conformity (e.g. should a product be rejected at the border if there are shortcomings in labelling?). Measures must be proportionate and consistent across the EU.

4.2.6    Better control of Internet commerce

E-commerce is a great challenge because it’s very difficult to trace products which are imported from non-EU countries, and to get the required information from the economic operators who are responsible for the product. A solution would be to improve market surveillance organisation and strategies with respect to internet commerce, as well as broadening the concept of economic operators.

There is an agreement on the need to incorporate Fulfilment Houses into new legislation (in particular, this might be achieved by including it in a revised Regulation on Market Surveillance), but also the need for clarity on market surveillance tools to be used for products bought online, either through guidance documents or legislative action.

The biggest future challenge in e-commerce is the changeover from imports of big consignments (containers with a number of the same products) sent to a distributer vs. a high number of small consignments consisting of only one product sent directly to the end user. In such a scenario, market surveillance authorities can only learn of a case when they are involved by customs.

Stronger border controls are also an important factor in terms of control procedures of products sold online. It is also necessary to improve the way authorities communicate market surveillance work electronically.

A Member State stresses the need for authorities' powers to purchase goods to be tested and to increase the budget for purchase and test of products found online. It also notes that MSAs face similar problems to those presented by Internet sales in cases of sales via catalogues (for example for construction products).

As to the products purchased through e-commerce platforms, the need to develop a method covering both border control, testing and cross-border communication between market surveillance and customs authorities is noted.

The Commission should capitalise on the opportunity presented by the revision of the E-commerce Directive and submit to the competent service the feedback from ADCOs on the needs of market surveillance over the internet.

4.2.7    More and/or better use of resources; tools to support market surveillance authorities 

Lack of resources has prevented some authorities from carrying out sufficient market surveillance in some specific sectors. Often, resources are just enough to cover one part of the total market surveillance activities as initially foreseen, so some specific sectors are neglected.

In the current climate it is unrealistic to expect Member States to attribute more funding to market surveillance and that the emphasis should be on how to use the existing allocation of resource more effectively, and to consider better and more effective ways to improve market surveillance. The Primary Authority system is considered as a good example of a model which the Commission and other Member States might wish to adopt more broadly.

The problem of limited resources can only be tackled by streamlining the whole market surveillance process, from planning to sanction the use of the latest technologies. The following specific suggestions are put forward:

Carry out studies on the inherent risk of the different product categories under the different directives; as an example, see the preliminary study for the next Ecodesign working plan.

Collect information on the number of product categories on the European market: this is one of the crucial factors in determining the “adequate scale of the checks” stipulated in Art. 19 (1) of Reg. 765.

Consider mandatory registration in a product database, as is done partially under the RED, and is envisaged for energy labelling and adaptation of existing registration obligations (WEEE directive) to make them suitable for market surveillance planning.

Facilitate checks at the border by including information on the manufacturer in customs declarations, and amending CN (Combined Nomenclature) to make it useful for market surveillance purposes.

Facilitate documentary checks via a digital compliance system (see below) and by including compulsory photos in the DoC to enable a positive identification of products, EAN (Bar)-Codes and CN-Codes.

Future standardisation mandates, including affordable preliminary testing: only products exceeding the preliminary limits would deserve full testing.

Simplification of reporting duties by providing an integrated IT solution from planning to documentary checks to product identification and reporting.

Market surveillance should be risk-based and should focus on the minority of non-compliant products that pose a high risk to persons, livestock and property, while other non-conformities should be addressed by means of education of businesses (see proposals under section 4.1 above).

The lack of notified bodies and testing laboratories in many technical areas is stressed, which makes testing of products expensive. This lack of laboratories might be a problem in some sectors, however not in all.

For market surveillance authorities without their own laboratories, budget and administration of external testing costs are a major issue limiting the effectiveness of their surveillance. Thus, programs facilitating sufficient laboratory capacity would be necessary. EU-wide agreements with laboratories, to which market surveillance authorities could send products to be tested on a pro-rata basis, would be a perfect solution.

This option of EU-wide agreements with laboratories is also proposed by another Member State, while another one suggests EU financial support from the Commission for laboratory tests (rather than for 'joint actions', which imply prohibitive administrative costs for MSAs).

On the other hand, the availability of laboratories is not considered as an issue by other Member States, since they believe they have excellent access to a number of test laboratories (test houses) which are also available for other Member States to use. It is not necessary or proportionate to introduce this at a supranational level.

A Member State also stresses the need for: (i) an on-line database where the national market surveillance authorities would be able to download the harmonised standards; (ii) the creation of a rapid advice forum at EU level; (iii) legal assistance from the Commission.

The simplification of the work of national authorities by means of an easier administration of joint actions and an integrated reporting system is suggested.

A very serious reshaping by the Commission of the internal approval procedure for joint actions is needed.

Finally, the need for adequate and reliable 'facts and figures' on products, volumes and economic operators is stressed as a necessary basis for developing and improving a risk-based approach. This kind of information is also considered useful in showing the importance of market surveillance.

4.2.8    Stronger measures against economic operators; Penalties

There is a need to take stricter measures against economic operators and to apply sanctions against economic operators located in third countries.

The harmonisation of the levels of penalties has been considered by one Member State, while keeping the possibility to adapt them on a case by case basis.

However, another Member State considers that penalties must remain the responsibility of Member States – it is for the Member State to determine what is effective, proportionate and deterrent. It is therefore also for the Member State to revise its legislation if it does not provide a sufficient deterrent.

For SMEs especially, limited financial leeway implies limited ability to react to more deterrence.

4.2.9    Digital compliance

There should be a greater emphasis on e-commerce and e-compliance as there are many more opportunities to take advantage of new and developing technology and make market surveillance more effective (e.g. using e-labelling whereby relevant information is provided online at the point of purchase).

Studying the impact of a possible e-compliance system, which could be useful for strengthening border controls, is supported: the system could be tried for products manufactured outside the EU, for which the technical documentation is more complicated to obtain.

The need for a database where manufacturers upload their declarations of conformity, technical documentation and instructions for easy reference by market surveillance authorities is stressed. This database would facilitate data collection of checked products but also provide an excellent basis for information on new and revised products on the market.

By contrast, other Member States strongly disagree with the suggestion of developing a digital compliance system. Some of the reasons reported are:

·The main problem for market surveillance authorities is not access to documentation but the fact that the documentation received does not always correspond to the actual product. The problem of falsified certificates etc. will not be solved by a digital system.

·The authorities cannot trust the data in the system, because they are supplied by those they are supposed to check.

·While a voluntary system would provide no added value, a mandatory system would create unjustified administrative burdens for economic operators as well as for market surveillance authorities. Compliant economic operators are already put at a competitive disadvantage vis-à-vis rogue traders, who will either report nothing or report false information to the system. Businesses in third countries would more easily escape the application of a mandatory system.

·It could lead to a practice where authorities allow undue time and resources to checking documentation in the database instead of focusing on the actual compliance of products. There is a fear that the emphasis will shift from checking products to checking the data entered in the system, without consideration of the reality of the market.

·There are many questions regarding the confidentiality of data in such a system.


Annex 3: methods and analytical models used in preparing the Evaluation

The methodology used in preparing the valuation consists of the desk research, the field research and the case studies.

The desk research focused on an in-depth review of the national market surveillance programmes and reports drafted by Member States pursuant to Article 18(6) of Regulation (EC) 765/2008 2 covering also the sectoral impact assessments drafted by the European Commission 3 for the relevant product categories covered by the Regulation, together with other policy documents relevant for market surveillance such as the Impact Assessment (IA) for the Regulation or the IA for the Product Safety and Market surveillance Package.

The market analysis is aimed at providing an understanding of the market for which EU harmonised product rules exist and at assessing the main trends in the intra EU trade of harmonised products. In order to identify the variables to be included in the analysis, we started from the reference list of sectors included in the EC template in its version published on 26 October 2015 and we tried to identify the available statistics that are useful for the scope of the study. A two-stage approach was implemented: an analysis at the sectoral level oriented towards the macro dimension and an analysis at the product level focused on the value of products that are traded within the EU internal market and for which EU harmonised rule exist (hereafter harmonised products).

Results from these analyses have been combined to identify the sectors whose trade value in harmonised products is more relevant.

The field research made use of a combination of field research tools, namely five targeted surveys and 23 interviews, plus the results of a Public Consultation launched by the Commission. 4  

As for the geographical coverage of the stakeholder consultation, all EU Member States, together with Iceland, Norway, Switzerland and Turkey, were involved in the consultation.

Five thematic case studies aimed at gathering a deeper understanding of all the issues covered by the evaluation questions. Each case study required four interviews for in-depth investigation.

Detailed analysis of each method is provided in Annex 4.



Annex 4: Ex-post evaluation of regulation (ec) no 765/2008

ABSTRACT (EN)

Regulation (EC) No 765/2008 aims at strengthening the protection of public interests, through reducing the number of non-compliant products on the EU Internal Market, and at ensuring a level playing field among economic operators, providing a framework for market surveillance and controls of products.

The evaluation aimed at understanding to what extent the Regulation has achieved these objectives. Moreover, it analysed the Regulation’s practical implementation in the EU Member States and assessed the market for products in its scope.

The evaluation concluded that the Regulation is not fully effective in achieving its objectives. Moreover, it has a limited cost effectiveness due to its partial achievement of both expected results and impacts, and to both resources allocated to enforcement and related activities not being correlated to the size of surveyed markets. The needs addressed by the Regulation are still relevant, although there exist a number of issues that could call this into question, particularly with respect to increasing online trade and budgetary constraints at national level. Moreover, the scope of the Regulation is not fully clear and its market surveillance provisions suffer from a lack of specificity. This allowed for different implementations at the national level, which impact on the level of uniformity and rigorousness of market surveillance controls across the EU. Finally, the coherence of the Regulation with respect to the GPSD and sectoral directives is not straightforward and this reduces the clarity of the overall framework for market surveillance.

ABSTRACT (FR)

Le règlement (CE) N° 765/2008 vise à renforcer la protection des intérêts publics en réduisant le nombre de produits non conformes sur le marché intérieur de l'Union Européenne (EU). Il vise également à assurer des conditions équitables entre les opérateurs économiques en fournissant un cadre pour la surveillance du marché et le contrôle des produits.

L’objectif de l’évaluation était de comprendre dans quelle mesure le règlement a atteint ces objectifs. En outre, les analyses de la mise en œuvre du règlement dans les États membres et du marché inclut dans son champ d’application ont été conduites.

En conclusion, il apparait que le règlement n'est pas pleinement efficace dans l’accomplissement de ses objectifs. De plus, il a un rapport coûts-efficacité limité en raison de l’accomplissement partiel soit des résultats soit des impacts attendus, ainsi que des ressources deployées et des activités connexes à l'exécution qui ne sont pas corrélées à la taille des marchés contrôlés. Les besoins abordés par le règlement sont toujours pertinents, bien qu'il existe des problèmes susceptibles de les remettre en question, en particulier en ce qui concerne l'augmentation des pratiques de commerce en ligne et des contraintes budgétaires au niveau national. En outre, le champ d'application du règlement n'est pas entièrement clair et ses dispositions manquent de spécificité. Ceci a conduit à des implémentations différentes au niveau national, qui ont eu un impact sur le niveau d'uniformité et de rigueur des contrôles du marché dans l'UE. Enfin, la cohérence du règlement par rapport à la DSGP et aux directives sectorielles n'est pas toujours évidente, ce qui réduit la clarté du cadre général de la surveillance du marché.

ABSTRACT (DE)

Die Verordnung (EG) Nr. 765/2008 hat das Ziel, die öffentlichen Interessen zu schützen, indem sie die Anzahl der nichtkonformen Produkte im europäischen Binnenmarkt reduziert und durch die Vorgabe eines Rahmens für die Marktüberwachung und die Produktkontrolle allen Wirtschaftsakteuren die selben Wettbewerbsbedingungen garantiert.

Die Evaluation hatte zum Ziel, zu verstehen, in welchem Ausmass die Marktüberwachungsbestimmungen der Verordnung ihre Zielsetzung erreicht haben. Zudem wurde die konkrete Umsetzung dieser Bestimmungen in den EU Mitgliedstaaten analysiert und der Markt für Waren im Geltungsbereich der Verordnung festgestellt.

Die Evaluation kam zu dem Schluss, dass die Verordnung ihr Ziel nicht vollständig erreicht hat. Ausserdem weist diese eine eingeschränkte Kostenwirksamkeit auf, was einerseits darauf zurückzuführen ist, dass die erwarteten Ergebnisse und Auswirkungen nur teilweise realisiert wurden, und andererseits auf eine fehlende Korrelation der Durchsetzungsressourcen und –tätigkeiten mit der Größe der befragten Märkte. Die in der Verordung angegangenen Bedürfnisse sind immer noch relevant, obwohl eine gewisse Anzahl an mit der Marktüberwachung der Online-Verkäufe und den steigenden nationalen Haushaltszwängen verbundenen Angelegenheiten besteht, die dies in Frage stellen könnten. Zudem ist der Rahmen der Verordung nicht eindeutig definiert und die darin enthaltenen Marktüberwachungsbestimmungen leiden unter einem Mangel an Spezifität. Dies hat auf nationaler Ebene zu verschiedenen Implementationen geführt, welche die Einheitlichkeit und Rigorosität der europaweiten Marktüberwachungskontrollen beeinträchtigen. Die Schlüssigkeit der Verordnung, was die Richtlinie über die allgemeine Produktsicherheit und die sektorspezifischen Richtlinien betrifft, ist nicht eindeutig und dadurch reduziert sich die Klarheit der gesamten Rahmenbedingunen der Marktüberwachung.

EXECUTIVE SUMMARY (EN)

Regulation (EC) No 765/2008 (hereinafter also referred to as ‘the Regulation’) setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 5 has been applicable since 1 January 2010. The Regulation has the strategic objectives of ‘strengthening the protection of public interests through the reduction of the number of non-compliant products on the EU Internal Market and ensuring a level playing field among economic operators’, providing a framework for market surveillance and product control.

The evaluation

The evaluation performed aimed at understanding to what extent the Regulation has achieved its original objectives in terms of effectiveness, efficiency, relevance, coherence, and EU added value. Moreover, it analysed the practical implementation of the Regulation in EU Member States and assessed the product market within the scope of the Regulation. 

This evaluation also aimed to contribute to the identification of the relevant set of actions supporting this Regulation within the framework of the Single Market Strategy.

Effectiveness

The evaluation concluded that the Regulation is not fully effective.

In particular, although a plethora of coordination and communication mechanisms and tools for information exchange exist within and between the individual Member States and with third countries, these do not work efficiently or effectively enough (e.g. Market surveillance authorities (MSAs) rarely restrict the marketing of a product following the exchange of information on measures taken by other MSAs; and in the context of products manufactured outside the national territory, MSAs find it difficult to contact the economic operator even if it is based in another EU Member State). Moreover, Member States have implemented the Regulation in many different iterations, with substantial variations in terms of organisational structures, level of resources deployed (financial, human and technical), market surveillance strategies and approaches, powers of inspection, and sanctions and penalties for product non-compliance. Finally, although Customs’ powers are perceived as adequate and procedures for border controls are clear and appropriate, checks on imported products are still considered inadequate in light of increasing import from third countries – particularly China – and online sales.

All these elements have had an impact on achieving uniform and sufficiently rigorous controls. Thus, they have also had an impact on the effectiveness of the measure in achieving its objectives in terms of protecting public interests and the level playing field for EU businesses.

The Regulation’s effectiveness towards achieving its objectives is also thrown into question by the increasing number of non-compliant products included in its scope, as demonstrated by the rising number of RAPEX notifications and restrictive measures taken by MSAs. An important reason for product non-compliance in the internal market seems to relate in particular to a lack of knowledge among economic operators about the applicable legislative requirements.

Efficiency

The Regulation introduces costs for Member States and, to a more limited extent, for economic operators. The former are related to organisational, information, surveillance, and cooperation obligations; costs for economic operators relate to information obligations, as defined in Article 19 of the Regulation.

The budget allocated to MSAs in nominal terms varies considerably from one Member State to another. These differences might be related to the fact that Member States have different organisational models requiring different levels of financial resources. However, another possible explanation might be sought in the different approaches followed by MSAs in reporting data on the level of financial resources used and on activities performed.

The fact that Member States are free to define their own approaches to market surveillance created a significant variation in the way the different sectors are controlled and managed. Moreover, fragmentation of control activities throughout the internal market may interfere with timely action by the authorities and cause additional costs for businesses.

As regards costs for economic operators, information costs are not perceived as significant although some cross-border inconsistencies still remain and the current enforcement mechanism is unable to create a level playing field for those businesses marketing products in the internal market. This might reduce businesses' willingness to comply with the rules and discriminate against businesses that abide by the rules and those who do not.

The analysis of RAPEX database and of national reports highlighted that product non-compliance increased consistently from 2006-2009 to 2010-2015.

The limited cost effectiveness of the market surveillance provisions is confirmed by the fact that neither the average annual budgets allocated to MSA activities nor their variation during the period 2011-2013 correlate with the size of the market (i.e. number of enterprises active in the harmonised sectors).

Relevance

Overall, the Regulation is relevant, although the study concluded there were issues which could put this into question.

For instance, the scope of the Regulation is not fully clear. This drawback could eventually be exacerbated by technological developments which introduce new types of products. As for the Regulation’s definitions, although they are generally clear and appropriate, they are not complete and up to date, especially when considering the need to address online sales. The concept of lex specialis represents a suitable interface to address market surveillance in specific sectors. However, some issues have emerged regarding a lack of clarity in the scope of market surveillance rules in sector-specific legislation. 

Considering the relevance of the Regulation to stakeholders’ needs, the analysis concluded that it is relevant to some extent. Overall, it is relevant when considering current needs associated to its general and specific objectives, but it becomes less relevant when referring to the needs related to new/emerging dynamics, especially with reference to increasing online trade and budgetary constraints at the national level.

Coherence

The evaluation concluded that the Regulation’s market surveillance provisions are coherent within themselves; and the roles and tasks of all the different stakeholders are well defined and there are no traces of duplication of activities. However, they suffer from a lack of specificity, which has allowed for discrepancies in implementation of the Regulation at the national level. As for external coherence, some issues have been identified between the GPSD and the Regulation mainly in terms of definitions provided, which are not always aligned. Moreover, the boundary between the two legislations is not always clear. Similarly, the Regulation’s coherence with sectoral directives is questioned, as there are discrepancies and gaps in the definitions and terminology provided in the different legislative pieces. Although not hindering the implementation of the Regulation, these inconsistencies diminish the overall clarity of the framework for market surveillance, causing some uncertainties in its application.

EU added value

The analysis focused on assessing the EU added value as per the Regulation’s specific provisions. Its EU added value mainly stems from provisions envisaging common information systems for cooperation and coordination, favouring administrative cooperation, and enhancing collaboration between Customs and MSAs. Conversely, the EU added value provided by provisions related to collaboration between Member States, market surveillance organisation at national level and national programmes and reports has not reached its full potential.

RÉSUMÉ (FR)

Le règlement (CE) N° 765/2008 (ci-après dénommé "le règlement") fixant les prescriptions relatives à l'accréditation et à la surveillance du marché pour la commercialisation des produits est devenu applicable depuis le 1er janvier 2010. Le règlement vise à renforcer la protection des intérêts publics à travers la réduction du nombre de produits non conformes sur le marché intérieur de l'UE et à assurer l'égalité des conditions entre les opérateurs économiques, en fournissant un cadre pour la surveillance du marché et le contrôle des produits.

L'évaluation

L'évaluation portait sur les dispositions de surveillance du marché du règlement. L’objectif était de comprendre dans quelle mesure le règlement a atteint ses objectifs en termes d'efficacité, d’efficience, de pertinence, de cohérence et de la valeur ajoutée de l'UE. En outre, les analyses de la mise en œuvre du règlement dans les États membres et du marché inclut dans son champ d’application ont été conduites.

Cette évaluation visait également à identifier les actions qui appuient le présent règlement dans le cadre de la Stratégie du marché unique.

Efficacité

En conclusion, il apparait que le règlement n'est pas pleinement efficace.

Bien qu'il existe une pléthore de mécanismes et d'outils de coordination et de communication pour l'échange d'informations au sein et entre les différents États membres et avec les pays tiers, ceux-ci ne fonctionnent pas efficacement ou efficientement (par exemple, les autorités de surveillance du marché restreignent rarement la commercialisation d'un produit suite à l'échange d'informations sur les mesures prises par d'autres autorités de surveillance et, dans le cadre de produits fabriqués en dehors du territoire national, les autorités de surveillance ont des difficultés à contacter l'opérateur économique même s’il est basé dans un autre État membre de l'UE. En outre, les États membres ont mis en œuvre le règlement de différentes façons, avec des variations substantielles en termes de structures organisationnelles, de niveau de ressources déployées (financières, humaines et techniques), de stratégies et d'approches de surveillance du marché, de pouvoirs d'inspection et de sanction, et de pénalités pour les produits non conformes. Enfin, bien que les pouvoirs des douanes soient perçus comme adéquats et que les procédures de contrôle des frontières soient claires et appropriées, les contrôles des produits importés sont encore considérés comme insuffisants à la lumière des importations croissantes en provenance de pays tiers - en particulier de la Chine - et des ventes en ligne.

Tous ces éléments ont eu un impact sur l’uniformité et la rigueur des contrôles. Par conséquent, ils ont également eu un impact sur l'efficacité de la mesure à atteindre de ses objectifs en termes de protection des intérêts publics et de conditions équitables pour les entreprises de l'UE.

L'efficacité du règlement dans la réalisation de ses objectifs est également mise en question par l'augmentation du nombre de produits non conformes inclus dans son champ d'application, comme en témoigne le nombre croissant des notifications sur RAPEX et des mesures restrictives prises par les autorités de surveillance du marché. Une raison importante pour la non-conformité des produits sur le marché intérieur semble concerner en particulier un manque de connaissance des opérateurs économiques des exigences législatives applicables.

Efficience

Le règlement introduit de nouveaux coûts pour les États membres et, de manière plus limitée, pour les opérateurs économiques. Les coûts pour les États membres sont liés aux obligations d'organisation, d'information, de surveillance et de coopération. Les coûts pour les opérateurs économiques sont liés aux obligations d'information définies à l'article 19 du règlement.

Le budget alloué aux autorités de surveillance du marché en termes nominaux varie considérablement d'un État membre à l'autre. Ces différences pourraient être liées au fait que les États membres ont des modèles organisationnels différents, qui nécessitent différents niveaux de ressources financières. Cependant, une autre explication pourrait être explorée attrayant aux différentes approches suivies par les autorités de surveillance du marché dans la déclaration des données concernant les ressources financières utilisées ainsi que les activités réalisées.

Le fait que les États membres soient libres de définir leurs propres approches à la surveillance du marché a créé une forte variation dans la manière dont les différents secteurs sont contrôlés et gérés. En outre, la fragmentation des contrôles dans l'ensemble du marché intérieur peut entraver l'action opportune des autorités et générer des coûts supplémentaires pour les entreprises.

En ce qui concerne les coûts pour les opérateurs économiques, les coûts de l'information sont perçus comme non significatifs, mais des incohérences transfrontalières subsistent, et le mécanisme d'application actuel n'est pas en mesure de créer des conditions de concurrence équitables pour les entreprises qui vendent des produits dans le marché intérieur. Ceci pourrait réduire la volonté des entreprises de se conformer aux règles et discriminer les entreprises qui respectent les règles contre celles qui ne le font pas.

L'analyse de la base de données RAPEX et des rapports nationaux a mis en évidence que la non-conformité des produits a augmentée constamment de 2006-2010 à 2010-2015. Une augmentation des notifications RAPEX et des mesures de surveillance peut également signifier que les autorités de surveillance sont devenues plus efficaces à détecter -et donc à corriger- les produits non conformes. Cependant, cela souligne aussi que le règlement n'est pas toujours capable d'accroître la volonté des entreprises de se conformer aux règles, discriminant ainsi les entreprises qui respectent les règles contre celles qui ne le font pas.

Le faible rapport coût-efficacité des dispositions de surveillance du marché est confirmé par le fait que ni les budgets annuels moyens alloués aux activités des autorités de surveillance du marché ni leurs variations par rapport à la période 2011-2013 ne sont corrélées avec la dimension du marché (c'est-à-dire le nombre d'entreprises actives dans les secteurs harmonisés).

Pertinence

Globalement, le règlement est pertinent, même si l'étude a identifié des problèmes susceptibles de remettre cette conclusion en question. Par exemple, le champ d’application du règlement n'est pas entièrement clair. Cette limitation pourrait être exacerbée par les développements technologiques qui introduisent de nouvelles typologies de produits. En ce qui concerne les définitions du règlement, même si elles sont généralement claires et appropriées, elles ne sont pas entièrement complètes et mises à jour, surtout lorsque l’on envisage de cibler les ventes en ligne. Le concept de lex specialis représente une interface adaptée à la surveillance du marché dans des secteurs spécifiques. Certaines questions ont néanmoins émergé en ce qui concerne le manque de clarté dans le champ d’application des dispositions de surveillance du marché dans les législations sectorielles.

En ce qui concerne la pertinence du règlement pour les besoins des parties prenantes, l'analyse a conclu que le règlement est pertinent dans une certaine mesure, car il est globalement pertinent lorsque l'on considère les besoins actuels associés à ses objectifs généraux et spécifiques. Toutefois, il devient moins pertinent si on examine les besoins liés aux dynamiques nouvelles/émergentes, en particulier en ce qui concerne l'augmentation du commerce en ligne et des contraintes budgétaires au niveau national.

Cohérence

L'évaluation a conclu que les dispositions de surveillance du marché du règlement sont cohérentes en elles-mêmes. Les rôles et les tâches de tous les acteurs concernés sont bien définis et aucune duplication des activités n'a été identifiée. Cependant, ces dispositions souffrent d'un manque de spécificité, qui a permis les divergences citées dans la mise en œuvre du règlement au niveau national.

En ce qui concerne la cohérence externe, certains problèmes ont été identifiés entre la DSGP et la réglementation, principalement en termes de définitions, qui ne sont pas toujours alignées. En outre, la démarcation entre les deux législations n'est pas toujours claire. La cohérence du règlement avec les directives sectorielles est mise en question de manière similaire. En effet, des divergences et des lacunes dans les définitions et la terminologie dans les différents textes législatifs ont été observées. Bien qu’elles n'empêchent pas la mise en œuvre du règlement, ces incohérences diminuent la clarté générale du cadre de la surveillance du marché, ce qui entraîne des incertitudes quant à son application.

Valeur ajoutée de l'UE

L'analyse a porté sur l'évaluation de la valeur ajoutée de l'UE conformément aux dispositions spécifiques du règlement. La valeur ajoutée du règlement résulte principalement des dispositions prévoyant des systèmes d'information communs pour la coopération et la coordination, favorisant la coopération administrative et renforçant la collaboration entre les autorités douanières et de surveillance du marché. En revanche, la valeur ajoutée de l'UE apportée par les dispositions relatives à la collaboration entre les États membres, à l'organisation de la surveillance du marché au niveau national et aux programmes et rapports nationaux n’a pas atteint son plein potentiel.

List of abbreviations

AdCO        Administrative Cooperation Group

CBA        Cost-benefit analysis

CLP        Classification, labelling and packaging

DG        Directorate-General

DG GROW    Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs

DG JUST    Directorate-General for Justice and Consumers

DG TAXUD    Directorate-General for Taxation and Customs Union

EC        European Commission

EEA        European Economic Area

EMC        Electro-magnetic compatibility

EU        European Union

FTE(s)        Full-time equivalent(s)

GPSD        General Product Safety Directive

IA        Impact assessment

ICSMS    Information and Communication System on Market Surveillance

IDB        Injuries database

IMP-MSG    Internal Market for Products – Market Surveillance Group

LVD        Low Voltage Directive

MS        Member State(s)

MSA(s)    Market surveillance authority(ies)

NACE    Nomenclature Générale des Activités Économiques dans les Communautés Européennes

PA    Public authority

PPE        Personal protective equipment

PROSAFE    Product Safety Forum of Europe    

RAPEX    EU Rapid Alert System for dangerous non-food products

REACH    Registration, Evaluation, Authorisation and Restriction of Chemicals

RED        Radio Equipment Directive

R&TTE    Radio and telecommunication terminal equipment

RoHS        Restriction of hazardous substances

SBS        Structural business statistics

SME(s)    Small- and Medium-sized Enterprise(s)

ToR        Terms of reference

WEEE        Waste electrical and electronic equipment

List of countries

AT        Austria

BE        Belgium

BG        Bulgaria

CY        Cyprus

CZ        Czech Republic

DE        Germany

DK        Denmark

EE        Estonia

EL        Greece

ES        Spain

FI        Finland

FR        France

HR        Croatia

HU        Hungary

IE        Ireland

IT        Italy

LT        Lithuania

LU        Luxembourg

LV        Latvia

MT        Malta

NL        Netherlands

PL        Poland

PT        Portugal

RO        Romania

SE        Sweden

SI        Slovenia

SK        Slovakia

UK        United Kingdom

1.    Introduction

This report responds to the request for services concerning an ex-post evaluation of the application of the market surveillance provisions of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. The request for services was issued by the European Commission (EC), Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) unit B1.

The study was led by EY with the support of Technopolis Group and Nomisma. The evaluation took place from July 2016 until May 2017.

1.1    Scope of the evaluation

The subject of this evaluation is Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008, setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.

The scope of the study is defined as follows:

·Legislation: Regulation (EC) No 765/2008, with specific reference to some selected articles:

­Chapter I, Article 2 (1) to (7), (14), (15), (17), (18), (19) and (21), on definitions;

­Chapter III (i.e. Articles 15 to 29) on the EU market surveillance framework and controls on products entering the EU market;

­Chapter V (i.e. Articles 31 to 37) as regards the Union’s financing of market surveillance activities;

­Articles 38 and 41 of Chapter VI, respectively, provide for the possible adoption by the Commission of non-binding guidelines in consultation with stakeholders, and obliges Member States to lay down rules on penalties for economic operators applicable to infringements of the provisions of the Regulation and to take all measures necessary to ensure that they are implemented;

·Time frame: the period from 2010 (date of application of the Regulation) to 2015, compared to the situation before 2010;

·Territory: the 28 EU Member States;

·Stakeholders: national authorities responsible for market surveillance of non-food products falling within the scope of Regulation (EC) No 765/2008, external border controls authorities, businesses and selected representatives from organisations of stakeholder categories (e.g. industry and SMEs, consumers and user associations).

1.2    Purpose of the evaluation

The overall objectives of the study are to:

·Evaluate to what extent the Regulation has achieved its original objectives in terms of effectiveness, efficiency, relevance, coherence and EU added value;

·Analyse the legal and practical implementation of the Regulation in EU Member States in order to identify particular issues and problems;

·Provide a better understanding of the market of mass consumer products and selected categories of professional goods in the EU, identifying the main trends in international trade and evaluating the relevant environmental, social and economic impacts deriving from implementation of the Regulation.

Bearing in mind that Regulation (EC) No 765/2008 sets out the legal framework for removing non-compliant products from the market in the area of EU harmonisation legislation, its evaluation will contribute to the identification of the relevant set of actions supporting this Regulation within the framework of the Single Market Strategy.

1.3    Structure of this report

This final report provides the full results of the analyses.

In more detail, Chapter 1 presents a summary of the scope and objectives of the evaluation.

Chapter 2 presents the background of the Regulation, including the legislative framework and the main provisions of the Regulation. It also includes the intervention logic framework used as a basis for the evaluation process.

Chapter 3 presents the evaluation questions, framed within the five evaluation criteria, which were answered to assess the Regulation and how the criteria are to be understood.

Chapter 4 presents the evaluation methodology used in the study, comprising desk research, field research (section 4.2.2) and case studies. Furthermore, it details difficulties encountered during the data-collection phase due to the lack of information and data limitations, together with the mitigation measures adopted.

Chapter 5 is mainly descriptive and presents the implementation state of play, particularly the market analysis, the dimension of product non-compliance and implementation of the Regulation at the national level.

Chapter 6 provides detailed answers to the evaluation questions, according to each evaluation criteria, and on the basis of the evidence gathered.

Chapter 7 includes conclusions on the effectiveness, efficiency, relevance, coherence, and EU added value of the Regulation.

Finally, the Annexes include the results of the stakeholder consultation, five case studies, an overview of the penalties imposed by Member States for infringements relating to Regulation (EC) No 765/2008, tables presenting data on laboratories and powers available to national MSAs and Customs across Member States, the mapping of national reports and programmes), evaluation grids, the questionnaires of the targeted surveys and interviews, some specific data on the market, and the list of information sources.

2.    Background of the initiative 

2.1    Legislative background

The mid-1980s marked the beginning of a period of profound legislative revision relating to the marketing of products in the EU, with the adoption of the so-called ‘New Approach’. The aim was to focus EU legislation only on the essential public interests requirements with which products must comply, leaving the definition of detailed technical requirements with standards. The New Approach contributed to the establishment of the European standardisation process 6 and the creation of EU harmonisation legislation. 7

With Regulation (EEC) No 339/93, the EU institutions focused, for the first time, on a market surveillance framework and on common procedures for controlling products coming from non-EU countries to assure their conformity with the safety rules applicable in the internal market.

As the next step along the harmonisation path, in 2001, the EU legislator enhanced the level of consumer safety by adopting Directive 2001/95/EC – the so-called General Product Safety Directive (GPSD). Considering the principle of lex specialis, the general safety requirement of the GPSD did not apply to medical devices or cosmetics and other product categories which fall under specific EU harmonisation legislation. Nevertheless, in most cases, some of its market surveillance provisions applied to consumer products falling under these rules at least until the alignment of those provisions to the reference provisions of Decision 768/2008/EC (see below). However, those market surveillance provisions did not apply to non-consumer products or to consumer products subject to requirements not related to safety.

In 2002, the EC initiated a public consultation to identify the main weaknesses of the ‘New Approach Directives’. The results suggested the need for a reform process focusing on the lack of confidence in the notified institutions and throughout the whole notification process, weaknesses in market surveillance and the need for more enforcement measures, inconsistencies between different directives, and a misunderstanding of the value and role of CE marking. During subsequent years, a vibrant dialogue among EU institutions, EU Member State experts and relevant stakeholders has led to the review of the New Approach initiatives 8 and to the adoption of the New Legislative Framework (NLF) in 2008. The latter strengthened rules for product marketing, the free movement of goods, the EU market surveillance system and European conformity marking for the free marketability of products in the European Economic Area (EEA) (internal market).

As a result, following an impact assessment, the EU institutions adopted Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93. With specific regard to market surveillance, such legislation:

·Sets obligations for EU countries to carry out market surveillance and to prohibit or restrict the marketing of dangerous or non-compliant products, providing a high level of protection of public interests;

·Lays down minimum common requirements for the organisation of market surveillance authorities (MSAs) at the national level;

·Provides MSAs with the powers to obtain all necessary documentation from economic operators in order to evaluate product conformity and act accordingly;

·Includes obligations for EU countries to ensure cooperation at national and cross-border levels and provides for specific tools to coordinate activities carried out by national surveillance bodies across the EU;

·Sets obligations to perform border controls of products entering the EU and lays down a procedure for the cooperation between market surveillance and Customs authorities.

Moreover, it lays down rules on:

·The concepts applicable in the field of product marketing;

·The organisation and operation of accreditation of conformity-assessment bodies;

·The general principles of the CE marking.

The scope of Regulation (EC) No 765/2008 was to establish an overarching framework on market surveillance, putting in place an overall policy and infrastructure across the Union without having to detail legislative provisions sector by sector. Furthermore, it aimed to address a certain lack of coherence in the implementation and enforcement of technical legislation regarding the free circulation of products within the EU. 9

Together with the Regulation and within the NLF, the EU legislators also adopted Decision No 768/2008/EC 10 on a common framework for marketing products in the EU, and Regulation (EC) No 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another EU country. Decision No 768/2008/EC includes reference provisions to be incorporated whenever product legislation is revised, working as a ‘template’ for future product harmonisation legislation. The reference provisions also cover relevant market surveillance procedures which are considered as complementary to the provisions of Regulation (EC) No 765/2008. However, they are not directly applicable and thus need to be incorporated into sector-specific harmonisation rules. Therefore, in recent years, a main objective of the Commission has been to bring product harmonisation legislation in line with the reference provisions of Decision No 768/2008/EC . At the time of writing, the following Directives and Regulations had been aligned with these reference provisions:

· Toy Safety – Directive 2009/48/EU ;

· Transportable pressure equipment – Directive 2010/35/EU ;

· Restriction of Hazardous Substances in Electrical and Electronic Equipment – Directive 2011/65/EU ;

· Construction products – Regulation (EU) No 305/2011 ;

· Pyrotechnic Articles – Directive 2013/29/EU ;

· Recreational craft and personal watercraft – Directive 2013/53/EU ;

· Civil Explosives – Directive 2014/28/EU ;

· Simple Pressure Vessels – Directive 2014/29/EU ;

· Electromagnetic Compatibility – Directive 2014/30/EU ;

· Non-automatic Weighing Instruments – Directive 2014/31/EU ;

· Measuring Instruments – Directive 2014/32/EU ; 

· Lifts – Directive 2014/33/EU ; 

· ATEX – Directive 2014/34/EU ; 

· Radio equipment – Directive 2014/53/EU ; 

· Low Voltage – Directive 2014/35/EU ; 

· Pressure equipment – Directive 2014/68/EU ; 

· Marine Equipment – Directive 2014/90/EU ; 

· Cableway installations – Regulation (EU) 2016/424 ; 

· Personal protective equipment – Regulation (EU) 2016/425 ; 

· Gas appliances – Regulation (EU) 2016/426

Further proposals on medical devices and in vitro diagnostic (IVD) medical devices were very recently adopted.

In 2013, to further strengthen consumer safety and market surveillance rules, the EC adopted the so-called Product Safety and Market Surveillance Package. 11  

Currently, at the EU level, the basic market surveillance infrastructures comprises: (i) the RAPEX system, 12 through which Member States notify the Commission and other Member States about measures taken against products posing serious risks (the Commission then disseminates the information to other Member States); (ii) the general information support system intended to collect other information about market surveillance activities performed by Member States, the so-called ICSMS (Information and Communication System for Market Surveillance); 13 (iii) the exchange of information on market surveillance programmes and (ex-post) on activities carried out; (iv) policy discussions on the implementation of product legislation through experts groups – e.g. administrative cooperation groups (AdCOs), 14  Internal Market for Products – Market Surveillance Group (IMP-MSG); and (iv) joint enforcement actions co-financed by the EU budget via grants.

2.2    Main provisions of the Regulation

Given the scope of this study presented in section 1.1, the current evaluation assesses several articles included in Chapter I, Chapter III, Chapter V and Chapter VI, specifically relating to market surveillance and detailed below.

Chapter I – General provisions

This chapter specifies the scope of the Regulation and the main definitions relevant for market surveillance.

Chapter III – EU market surveillance framework and controls of products entering the EU market

Chapter III covers the functioning of market surveillance of products subject to EU harmonisation legislation. It defines the products covered by the market surveillance infrastructures and programmes, as well as the roles and responsibilities of the EC, Member States, national MSAs and other relevant actors.

In particular, Section 1 defines the scope of application of the provisions on market surveillance and control of imported products. It also sets out the general obligation to carry out market surveillance and take restrictive measures for products found to be dangerous or non-compliant in relation to any product categories subject to EU harmonisation law, and to inform the EC and other Member States.

Section 2 EU market surveillance framework sets out the obligations of the EU MS regarding the organisation of national authorities and measures to be adopted in case of products presenting a serious risk. The section provides an overview of the duties of national MSAs and their cooperation with competent authorities in other EU MS or in third countries. The Regulation also states the principles of cooperation and exchange of information between all relevant actors in the field of market surveillance.

Section 3 Controls of products entering the EU market entrusts powers and resources to authorities in charge of external border control of products entering the EU market and defines the situations whereby such authorities shall not release a product for free circulation or, in case of suspension, shall release the product. Moreover, this section defines the measures to be taken by MSAs if a product presents a serious risk or does not comply with EU harmonisation legislation.

Chapter V – EU financing

This chapter includes provisions on the financing system for obtaining the results expected by the Regulation. More specifically, it lists the activities eligible for financing and arrangements on financial procedures. The Regulation also foresees the possibility of covering administrative expenses for all management and monitoring activities necessary to achieve its objectives.

Chapter VI – Final provisions

The last two provisions evaluated are Article 38, which refers to the possibility of the EC’s adoption of non-binding guidelines on Regulation implementation, and Article 41, which obliges the EU MS to lay down rules on penalties for economic operators for infringing the provisions of this Regulation.

2.3    Intervention logic framework

The intervention logic of the market surveillance provisions of Regulation (EC) No 765/2008 is crucial for clarifying the objectives and enhancing the understanding of the evaluation process. As explained in the Better Regulation Toolbox #41: ‘Designing the evaluation’, reconstruction of the intervention logic allows the evaluator to understand how the Regulation was expected to work, and identify the causal links among the different dimensions as well as the contextual elements that affect the current framework. The intervention logic framework is thus summarised below on the basis of the market surveillance provisions in the scope of this evaluation.

Three main needs or drivers led to the definition of the Regulation’s strategic objectives: (1) to address the lack of market surveillance enforcement within the EU; (2) to increase the credibility of CE marking in the internal market; and (3) to ensure the free movement of goods within the EU together with product safety and the protection of public interest. The two strategic objectives of the Regulation – aiming to respond to the above-mentioned needs - are: (1) to ensure a level playing field among economic operators through the elimination of unfair competition of non-compliant products; and (2) to strengthen the protection of public interests through the reduction of the number of non-compliant products. The strategic objectives are then disaggregated into three specific objectives representing the operational orientations of the EU action. To achieve the strategic and specific objectives, the EC has defined a set of activities to be implemented, and included them in the Regulation in the form of provisions. For instance, to reduce the number of non-compliant products, the Regulation sets the framework for controls of products on the internal market (Ch. III, section 2) and of those imported from third countries (Ch. III, section 3). These provisions are expected to produce a number of key results and to eventually trigger the Regulation’s impacts. For instance, the resulting lower number of non-compliant products will generate greater and more uniform protection of consumers across the EU.

The intervention logic below also presents the evaluation questions (and related criteria) contributing to assessing the overall performance of the Regulation, having identified its working mechanisms. As shown in the figure below, the evaluation questions related to relevance assess whether the Regulation’s objectives are still adequate in the current context. The effectiveness questions are based on measurements of the Regulation’s results to determine whether it has achieved its objectives. The efficiency questions assess whether the Regulation has proportionally delivered its results, given the established provisions. To better understand how the interaction between the above elements works and delivers the expected changes over time, the intervention logic must consider external factors that may influence the Regulation’s performance: the coherence questions evaluate whether the Regulation is consistent with those factors. The EU added value questions aim at understanding if the provisions set out have served to obtain the expected impacts.

The figure below outlines the Regulation’s intervention logic in relation to the evaluation criteria and questions that guided the study and that will be further described in the following chapter. The arrows represent the links/trigger mechanisms between needs and objectives, and objectives, provisions and results.

Figure 4-1 - Intervention logic of the Regulation

 

Source: EY

3.    Evaluation questions 

The box below presents 18 evaluation questions, framed within the five evaluation criteria that had been answered to assess the Regulation.

The evaluation criteria were understood to mean:

·Effectiveness: whether and to what extent the Regulation’s objectives in terms of ensuring a level playing field among economic operators by eliminating unfair competition of non-compliant products and strengthening the protection of public interests have been achieved at both national and EU levels (EQs 1-5).

·Efficiency: whether the Regulation has proportionally delivered its results in terms of resources used. The analysis included an assessment of the costs and benefits as perceived and reported by stakeholders. (EQs 6-9).

·Relevance: whether the Regulation’s objectives still correspond to current problems, needs and challenges, arising in particular from online sales, increase in imports from third countries, shortening product life, increasing budgetary constraints at the national level (EQs 10-13).

·Coherence: whether the Regulation is consistent within itself, with other market-relevant pieces of EU legislation on non-food products surveillance and within the wider EU policy framework (EQs 14-16).

·Added value: to what extent the results of the EU action are additional to the value that would have resulted from action at Member State level (EQs 17 and 18).

Effectiveness

EQ1.Are the results in line with what is foreseen in the impact assessment for the Regulation, notably as to the specific objectives of: (i) enhanced cooperation among Member States/within Member States, (ii) uniform and sufficiently rigorous level of market surveillance; and (iii) border controls of imported products?

EQ2.How effective was the measure as a mechanism and means to achieve a high level of protection of public interests, such as health and safety in general, health and safety at workplace, the protection of consumers, protection of the environment and security? What have been the quantitative and qualitative effects of the measure on its objectives?

EQ3.How effective was the measure as a mechanism and means to achieve a level playing field among businesses trading in goods subject to EU harmonisation legislation? What have been the quantitative and qualitative effects of the measure on its objectives?

EQ4.Are there specific forms of the implementation of the Regulation at Member State level that render certain aspects of the Regulation more or less effective than others , and – if there are – what lessons can be drawn from this?

EQ5.To what extent has the different implementation (i.e. discrepancies in the implementation) of the initiative in Member States impacted on the effectiveness of the measures on the objective?

Efficiency

EQ6.What are the regulatory (including administrative) costs for the different stakeholders (businesses, consumers/users, national authorities, Commission)?

EQ7.What are the main benefits for stakeholders and civil society that derive from the Regulation?

EQ8.To what extent have the market surveillance provisions been cost effective?

EQ9.Are there any significant differences in costs (or benefits) between Member States? If so, what is causing them?

Relevance

EQ10.To what extent are market surveillance provisions of the Regulation still relevant in the light for instance of increasing online trade, the increase in imports from third countries, shortening product life, increasing budgetary constraints at national level, etc.?

EQ11.To what extent do the effects of the market surveillance provisions satisfy (or not) stakeholders' needs? How much does the degree of satisfaction differ according to the different stakeholder groups?

EQ12.Is there an issue on the scope (i.e. all EU product harmonisation legislation) of the measure or some of its provisions?

EQ13.Is the concept of lex specialis still a suitable interface between the market surveillance provisions in the Regulation and those in other (notably sector) legislation?

Coherence

EQ14.To what extent are the market surveillance provisions coherent internally?

EQ15.To what extent are the market surveillance provisions above still coherent with other Union legislation on market surveillance of non-food products?

EQ16.To what extent are these provisions coherent with wider EU policy?

EU added value

EQ17.What is the additional value resulting from the market surveillance provisions at EU level, compared to what could be achieved by Member States at national and/or regional levels?

EQ18.To what extent do these provisions support and usefully supplement market surveillance policies pursued by the Member States? Do the provisions allow some sort of 'control' by the EU on the way national authorities carry out market surveillance?

4.    Methodology

This chapter summarises the tools and techniques used in the study to answer the evaluation questions. The final section describes data limitations and the solutions applied to the problems encountered.

4.1    Evaluation grids

The approach to answering the evaluation questions has been defined in specific evaluation grids presenting:

·The judgment criteria used to specify the meaning of the evaluation question;

·The analytical approach used to answer the evaluation question, given the judgement criteria;

·The indicators used to evaluate the achieved results as well as to identify potential shortcomings;

·The sources of information, including primary sources (i.e. stakeholders) and secondary sources, i.e. existing documents, publications, reports.

All evaluation grids are presented in Annex.

4.2    Overview on data collection and analysis tools

This section provides a synthesis of the main data collection and analytical tools used in the study: desk research, field research and case studies.

4.2.1    Desk research

4.2.1.1    Implementation

The desk research focused on an in-depth review of the national market surveillance programmes and reports drafted by Member States pursuant to Article 18(6) of Regulation (EC) 765/2008. 15 However, with particular regard to data for assessing the implementation of the Regulation at the national level, the analysis of national reports and programmes presented a number of lacks. In order to fill-in these gaps and following a specific request from the Steering Group, a template for data collection was sent to IMP-MSG representatives and Customs, requiring them to provide information on powers of sanction and control and availability of test laboratories across different sectors. The template was based on the same list of sectors published on the Commission’s website on November 2016 for the preparation of national market surveillance programmes, 16 and the list of sectors presented therein has also been used for the market analysis. The list should be considered as a non-exhaustive reference list of sectors falling within the scope of Regulation (EC) No 765/2008. The template, presented in the table below, is an updated version of that presented in Annex.

Table 4-1 – Non-exhaustive list of sectors in scope of the Regulation used for data collection

N.

Product sectors

Relevant legislation

1

Medical devices (including in vitro diagnostic and active implantable medical devices)

Directives 93/42/EEC, 98/79/EC and 90/385/EEC

2

Cosmetics

Regulation (EC) 1223/2009

3

Toys

Directive 2009/48/EC

4

Personal protective equipment

Directive 89/686/EEC

5

Construction products

Regulation (EU) 305/2011

6

Aerosol dispensers

Directive 75/324/EEC

7

Simple pressure vessels and Pressure equipment

Directives 2009/105/EC and 97/23/EC - Directives 2014/29/EU and 2014/68/EU

8

Transportable pressure equipment

Directive 2010/35/EU

9

Machinery

Directive 2006/42/EC

10

Lifts

Directive 1995/16/EC - Directive 2014/33/EU

11

Cableways

Directive 2000/9/EC

12

Noise emissions for outdoor equipment

Directive 2000/14/EC

13

Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres

Directive 1994/9/EC - Directive 2014/34/EU

14

Pyrotechnics

Directive 2007/23/EC - Directive 2013/29/EU

15

Explosives for civil uses

Directive 93/15/EEC - Directive 2014/28/EU

16

Appliances burning gaseous fuels

Directive 2009/142/EC

17

Measuring instruments, Non-automatic weighing instruments, Pre-packaged products and Units of measurement

Directives 2004/22/EC and 2009/23/EC - Directives 2014/32/EU and 2014/31/EU; Directive 2007/45/EC, 75/107/EEC and 76/211/EEC; Directive 80/181/EEC

18

Electrical equipment under EMC

Directive 2004/108/EC - Directive 2014/30/EU

19

Radio and telecom equipment under RTTE - RED

Directive 1999/5/EC - Directive 2014/53/EU

20

Electrical appliances and equipment under LVD

Directive 2006/95/EC - Directive 2014/35/EU

21

Electrical and electronic equipment under RoHS and WEEE and batteries

Directives 2011/65/EU, 2002/96/EC and 2006/66/EC

22/A

Chemical substances under REACH and Classification and Labelling Regulations

Regulations (EC) 1907/2006 and 1272/2008/EC

22/B

Other chemicals (Detergents, Paints, Persistent Organic Pollutants, Fluorinated greenhouse gases, Ozone Depleting Substances, etc.)

Regulation (EC) 648/2004, Directive 2004/42/EC, Regulation (EC) 850/2004, Regulation (EC) 842/2006 and Regulation (EU) 517/2014, Regulation (EC) 1005/2009

23

Eco-design and Energy Labelling; Efficiency requirements for hot-boilers fired with liquid or gaseous fuels

Directives 2009/125/EC and 2010/30/EU; Directive 1992/42/EEC

24

Tyre labelling

Regulation (EC) 1222/2009

25

Recreational craft

Directive 1994/25/EC - Directive 2013/53/EU

26

Marine equipment

Directive 96/98/EC -Directive 2014/90/EU

27

Motor vehicles and Tractors

Directive 2002/24/EC - Regulation (EU) 168/2013; Directive 2007/46/EC; Directive 2003/37/EC - Regulation (EU) 167/2013

28

Non-road mobile machinery

Directive 97/68/EC

29

Fertilisers

Regulation (EC) 2003/2003

30

Other consumer products under GPSD

Directive 2001/95/EC

31

Biocides

Regulation (EU) 528/2012

32

Textile and Footwear labelling

Regulation (EC) 1007/2011 and Directive 94/11/EC

33

Crystal glass

Directive 69/493/EEC

Source: EC (2016)

The desk research also covered the sectoral impact assessments drafted by the European Commission 17 for the relevant product categories covered by the Regulation, together with other policy documents relevant for market surveillance, such as the impact assessment (IA) for the Regulation and the IA for the product safety and market surveillance package. Moreover, a number of reports and studies on market surveillance issues have also been considered, such as EC (2017), 18 EP (2009), 19 Panteia (2014) 20 and PROSAFE (2013). 21 For more details on the information sources see Annex.

4.2.1.2 Market analysis

The market analysis set out to provide an understanding of the market for which EU harmonised product rules exist and to assess the main trends in the intra-EU trade of harmonised products. To identify the variables to be included in the analysis, we considered the sectors listed in the EC template for national programmes in the version published on November 2016, and we tried to identify statistics useful for the scope of the study (see Table 4-1 ).

We implemented a two-stage approach:

·An analysis at the sectoral level oriented towards the macro dimension, looking at:

­The number of economic operators active within the economic sectors for which EU harmonised product rules exist (hereafter harmonised sectors);

­The harmonised sector’s current contribution to the EU economy;

·An analysis at the product level focused on the value of products traded within the EU internal market and for which EU harmonised rules exist (hereafter harmonised products).

All data were extracted from three databases:

·Structural Business Statistics (SBS) 22 provided by Eurostat to describe the structure of harmonised sectors and measure their economic performance;

·PRODCOM - Statistics by Product 23  provided by Eurostat to estimate the value of harmonised products;

·International trade database, containing data since 1988 by Standard International Trade Classification (SITC), 24  provided by Eurostat to estimate the value of intra-EU trade of harmonised products. 25

Results from these analyses have been combined to identify those sectors where trade value in harmonised products is more relevant.

In detail, the approach comprised the following steps:

·Step 1. Identification of EU legislative acts introducing harmonised product rules (i.e. harmonising legislation);

·Step 2. Review of EU legislation introducing harmonised product rules;

·Step 3. Identification of the corresponding NACE Divisions (DIGIT 2) and NACE group (DIGIT 3) impacted by the EU Regulation (i.e. harmonised sectors);

·Step 4. Selection of the most appropriate products (NACE group – DIGIT 4) for which harmonised product rules exist and that should be included in the analysis.

All the above steps were needed to overcome the following issues:

·Definitions of sectors/products in the Regulation are usually different from nomenclatures used within statistics;

·Statistics at the sectoral/product level use different nomenclatures (e.g. intra-EU trade uses the SITC, production values use the PRODuction COMmunautaire (PRODCOM) nomenclature, business demographics uses the Statistical Classification of Economic Activities in the European Community - NACE);

·Difficulties in identifying harmonised sectors in cases where EU legislation introduced harmonised rules that only apply to some products within sectors.

For the sectoral-level analysis, data were extracted from the Eurostat structural business statistics (SBS) database 26 based on NACE Rev.2 classifications. In particular, we considered:

·Business demographic variables (i.e. number of enterprises);

·Input-related variables: labour input (e.g. number of people employed);

·Output-related variables (i.e. turnover, value added).

Results of this analysis refer to the indicators detailed in the table below.

Table 2 - Indicators for the sector-level analysis

Dimension

Indicator

Definition

Business demography

Number of enterprises

Number of active enterprises

Input

Number of people employed

Number of people aged 15 and over (or 16 and over in IE) who worked – even if just for one hour per week – for pay, profit or family gain.

Output

Value added at factor cost

The value added at factor cost is the gross income from operating activities after adjusting for operating subsidies and indirect taxes.

The value added at factor cost is calculated ‘gross’ as value adjustments (such as depreciation) are not subtracted. 27

Turnover

‘Turnover’ comprises the totals invoiced and corresponds to market sales of goods supplied to third parties. 28

The analysis at the product level aimed at understanding the market value of all traded products for which EU harmonised product rules exist. 29 The indicators considered in the analysis have also been extracted from Eurostat statistics currently available and are presented in the following table.

Table 3 - Indicators for the product-level analysis 30

Indicator

Definition

Coverage

Time frame

Source

Value of sold production

This indicator provides the monetary value of sold products.

EU-28

2008-2015

PRODCOM – Statistics by product 31

Value of extra EU imports

This indicator provides the monetary value of imported products from non-EU countries.

EU-28

2008-2015

Value of extra EU exports

This indicator provides the monetary value of exported products to non-EU countries.

EU-28

2008-2015

Value of intra-EU imports

This indicator provides the monetary value of imported products by all EU countries from other EU countries.

EU-28

2008-2015

EU trade since 1998 by SITC 32

All EU-28 Member States have been considered and the period covered by data is 2008-2015.

While the sectoral-level analysis provided an estimate of the number of economic operators potentially impacted by the Regulation’s market surveillance provisions and of how they are contributing the EU economy, the analysis at the product level gave an assessment of the value of traded goods that should comply with the existing harmonised product rules.

4.2.1.3    Cost-benefit analysis

To measure costs and benefits of the Regulation, the following elements have been analysed:

·Regulatory costs for the different stakeholders (MSAs and businesses);

·Main benefits for stakeholders and civil society deriving from the Regulation;

·Cost effectiveness of market surveillance provisions;

·Proportionality of the Regulation and differences between Member States.

The existing data were used for:

·Measuring the inputs (i.e. financial and human resources) used by MSAs in order to meet surveillance obligations deriving from the Regulation. MS should declare budget allocated to market surveillance and enforcement activities, including related infrastructures and projects and measures aimed at ensuring economic operators’ compliance with product legislation. These measures should also include communication activities (consumer/business information and education), enforcement, staff remuneration, direct costs of inspections, laboratory tests, training, and office equipment costs. This means that data included in the national reports might be considered as the best source of information in order to estimate the regulatory costs for national authorities. In particular, the following dimensions have been identified as relevant for this purpose:

­Financial resources available for market surveillance activities;

­Human resources available for market surveillance activities.

·Assessing how authorities’ market surveillance is meeting surveillance obligations (results). National reports were used to verify:

­Number of inspections performed by year and by sector

­Number of tests performed by year and by sector

·Evaluating the levels of compliance for harmonised products and the perceived effectiveness of the Regulation in ensuring a level playing field for businesses (impacts). Businesses and business associations took part in the targeted survey. In addition, 10 targeted interviews were conducted with these stakeholders to investigate:

­Whether the Regulation introduced any type of cost on consumers/end-users (e.g. derived from Article 19 stating that the MSAs may require economic operators to make available documentation and information regarding the products, to present test reports, or certificates attesting conformity);

­Whether introduced costs affect disproportionately a particular category of stakeholders;

­Whether the measures taken by MSAs are proportionate to their objectives and effective in ensuring product compliance and a level playing field for businesses;

­Whether any differences emerged across Member States in implementing the Regulation.

To measure the cost effectiveness of the Regulation, the analysis looked at the extent to which the desired effects (results and impacts) had been achieved at a reasonable cost.

Furthermore, proportionality of the Regulation and significant differences between Member States were also considered. In particular, the analysis assessed whether Member States incur costs to meet their surveillance obligations that are proportionate to the national markets of harmonised products (i.e. number of active enterprises active in the national markets).

4.2.2    Field research

The overall stakeholder consultation process for the evaluation of Regulation (EC) No 765/2008 began in June 2016 and continued until February 2017. It collected inputs from a wide range of stakeholders through different tools, namely:

·A public consultation 33 – involving 239 stakeholders;

·Five targeted consultations based on online surveys, involving 119 stakeholders and addressing:

­Member State coordinating authorities in charge of implementing the Regulation;

­MSAs in charge of enforcing the Regulation, including AdCO representatives;

­Customs authorities;

­Economic operators and industry associations;

­Consumer and user associations.

·39 interviews: 34

­9 of general character to further investigate the most relevant issues emerging from the desk and field research;

­20 targeted interviews aimed at building the five case studies;

­10 for collecting additional data for the cost-benefit analysis (CBA).

The public consultation and the five targeted consultations were conducted prior to the interviews, as the latter were aimed at complementing and triangulating the information collected and clarifying any emerging issues.

As for the geographical coverage of the stakeholder consultation, all EU Member States, together with Iceland, Norway, Switzerland and Turkey, were involved.

In chapter 6, when analysing data retrieved from the field research, percentages are calculated based on the actual number of answers received for each question in the targeted surveys or public consultation, thereby excluding:

·Answers that did not provide any information, i.e. ‘I do not know’;

·The ‘not applicable’ answers, i.e. when the specific question was not asked to some respondents as it was outside of their area of competence (in the targeted surveys);

·The ‘no answer received’, i.e. when the respondent decided to skip the question (in the targeted surveys).

In practice, percentages often have different calculation bases, and the base is usually below 239 for the public consultation and less than 119 for the targeted surveys.

A detailed overview of the stakeholder consultation is presented in Annex.

4.2.3    Case studies

Five thematic case studies aimed to develop a deeper understanding of all the issues covered by the evaluation questions. Each case study required four interviews for in-depth investigation.

Notably, the case studies allowed for:

·Ensuring a higher level of detail which would not have been feasible with reference to all the EU Member States and all the non-food products. Case studies have been used to produce useful insights on specific topics that emerged during the evaluation, and have helped in gaining a better understanding of the overall situation in the EU and the results achieved by the Regulation in different areas and activities;

·Illustrating in practical terms the implications and impacts of specific issues and understanding the causal links between the intervention and the achievements/results/ impacts;

·Providing more detailed and better evidence for answers to the evaluation questions;

·Identifying best practices and approaches.

The five case studies are reported in Annexes 0 to 0.

4.3    Data limitations

This section discusses the problems encountered, particularly the issues concerning data limitations related to the desk and field research.

4.3.1    Data gaps in the desk research

4.3.1.1Data gaps in estimates of product non-compliance

To assess the Regulation’s effectiveness in achieving its strategic objectives (i.e. protection of public interest and creation of a level playing field), an estimation of the dimension of product non-compliance across the EU and at the national level was necessary. However, significant data gaps and limitations made it difficult to provide a complete and reliable picture of the phenomenon. In order to attain at least a partial estimate of the issue, two solutions were implemented which had to rely on a number of assumptions.

First, although RAPEX notifications were used as a proxy for measuring product non-compliance they do not measure the precise extent of non-compliance, since each notification relates to many products. Moreover, only products presenting a serious risk are notified on RAPEX. Consequently, no products presenting formal non-compliance are included in these statistics, which further underestimates the real dimension of product non-compliance.

However, it is also true that the increase in the number of notifications may not only represent more products posing a safety risk, but also an increase in the effectiveness of MSAs in identifying these products, thereby increasing the level of consumers’ and users’ protection. Similarly, the rising number of RAPEX notifications may also be due to various external factors.

Some data provided in national reports can also be used as proxies for product non-compliance. The following indicators have been taken into account:

·Number of product-related accidents/user complaints;

·Number of corrective actions taken by economic operators;

·Number of inspections resulting in findings of non-compliance;

·Number of inspections resulting in restrictive measures taken by MSAs;

·Number of inspections resulting in the application of penalties.

Where possible, analysis of these data contributed to widening the overview, allowing for a possible comparison with information extracted from RAPEX. However, as explained below, there are a number of limitations and gaps on data retrieved from the national reports (e.g. they do not provide data for all EU Member States nor all sectors relevant to the Regulation; they only cover the period from 2010 to 2013; and the data provided are not always reliable and comparable). Therefore, to provide reliable information to the greatest extent possible, only the sectors where information on the above-mentioned indicators was reported by at least 15 Member States was considered. As a result, we have collected information on nine out of 30 sectors, although not all indicators are available for each sector. 35 Moreover, the group of Member States varies, depending on the indicator and sector considered.

4.3.1.2 Data gaps in the assessment of implementation

As far as the assessment of implementation is concerned, the main difficulties encountered while performing the desk research related to the differing levels of detail in the information provided by Member States. Since the countries encountered several difficulties in reporting data on available resources in terms of both budget and staff, information was only partially or not available at all for a large number of Member States for the following reasons:

·Data on resources were only available for some MSAs or for some sectors in 15 Member States; 36

·Data on resources were presented as estimates of the total budget as information was not disaggregated for market surveillance activities alone (Spain) or the national market surveillance framework comprised numerous and very different authorities (UK), meaning that data were not aggregated;

·Data on resources were not available due to the indirect federal administration, as there are numerous administrative units that perform market surveillance activities in Austria, for example;

·Data on resources were not reported by four Member States. 37

Additional limitations related to the fact that some Member States 38 reported financial data expressed in the national currency, requiring conversion to euros. Similarly, other Member States, 39 while requested to provide information on available staff in terms of full-time equivalents (FTEs)), 40 reported data in terms of staff numbers. Consequently, data on resources were incomplete. Due to these limitations, the information provided should be interpreted carefully.

Finally, the breakdown by product sector emerged as a critical factor. The desk research was structured according to the reference list of 30 product sectors provided by the EC in its ‘Template for drafting a national market surveillance programme pursuant to Article 18(5) of Regulation (EC) No 765/2008’ 41 . All Member States followed the classification suggested by the EC except Germany and Lithuania. Germany provided aggregated information on market surveillance activities performed during 2010-2013 and relating to the Product Safety Act. It transposed 12 European Directives included in the list of sectors covered by the Regulation. 42 The German national programme provides detailed information only for activities performed in sectors 18 and 19, while for other sectors data are aggregated. Lithuania did not adopt the EC template as it launched a study on national market surveillance in 2013 to assess how well its market surveillance system was functioning. However, this study did not include information on market surveillance controls and inspections performed on products covered by the Regulation.

4.3.1.3 Data gaps in national programmes

As far as national programmes are concerned, there is a lack of harmonisation in the programme year of reference. Most of the programmes analysed refer to 2015, but for some Member States, the programmes which referred to that year were not available. As a result, the national programmes referring to previous years (i.e. the Czech Republic’s national programme refers to 2013 43 ) and/or covering two or three years (i.e. Germany’s programme covered 2014 to 2017, Ireland and Slovakia covered 2014 and 2015; Portugal’s programme covered 2012 and 2013; while the Netherlands covered 2015 and 2016) were considered. Lithuania required the review of six sector-specific programmes as the general programme was not available, while the Romanian national programme covered 2016, since programmes for previous years were not available.

Moreover, information was not always complete and harmonised. In some cases, Member States did not follow the EC template when drafting national programmes, 44 thus reporting different information than that recommended. In other cases, 45 Member States only provided sector-specific data (i.e. corresponding to ‘Section 2’ in the EC template), without reporting all relevant information on the general market surveillance organisation and infrastructure. In such cases, we tried to gain an understanding of the implementation of market surveillance at the national level by ‘abstracting’ information from the sectoral programmes.

4.3.1.4 Data gaps in national reports

An initial, serious limitation of national reports related to gaps in data available on market surveillance activities, across sectors and Member States over the entire period 2010-2013. For example, data on accidents, penalties and restrictive measures in each sector are never available for more than 16, 18 and 20 Member States respectively. Moreover, when they are available, they are hardly comparable, having a very high variance. For instance, in the number of inspections performed, the resulting variance seems to stem from the different national interpretations of what constitutes an inspection (e.g. six Member States 46 include ‘visual inspections’, Denmark states that an important element of its market surveillance are inspections at trade fairs, while France lists ‘inspections on advertising’ among its activities. Moreover, Italy only reports the number of inspections ordered by the Ministry of Health, thereby excluding inspections performed by other MSAs on their own initiative). This made a thorough evaluation of the Regulation’s effectiveness and efficiency very difficult, and any comparisons between countries and sectors unlikely to be reliable.

Moreover, some national reports do not include all sectors listed in the EC template. 47 For instance, Austria excluded the marine equipment sector since it is not relevant for the country. Similarly, Denmark does not perform market surveillance in the cableway sector as the few ski slopes in the country have drag lifts. Lack of coordination within a Member State might be another reason for sector exclusion, inasmuch as the central authority responsible for market surveillance could not obtain the necessary information from sector-specific MSAs. 48 Against this background and according to the methodology used to structure the desk research, the main limitations on data availability related to sector coverage, 49 in particular:

·All or almost all sectors were covered by Bulgaria, the Czech Republic, Denmark, Finland, France, Hungary, Latvia, Malta, Poland, Romania, Sweden and Slovenia;

·More than two-thirds of the sectors were covered by Austria, Belgium, Cyprus, Estonia, Greece, Ireland and Portugal;

·About half of the sectors were covered by Italy, Luxembourg and Slovakia;

·Less than half of the sectors were covered by Spain and Croatia.

The sectors most frequently excluded by the national reports are:

·Efficiency requirements for hot-water boilers fired with liquid or gaseous fuels and non-road mobile machinery, which were only covered by nine Member States;

·Marine equipment, recreational craft, and noise emissions for outdoor equipment were covered by 14, 17 and 17 Member States respectively.

Table 4-52 provides a complete overview of geographical and sectoral coverage as per the national reports.

In addition to the sectors included in the reference list, a number of national reports also covered other product areas considered as relevant, in particular:

·Cigarette lighters, leather, products imitating foodstuffs, packaging, liquid fuels and wheeled tractors (BG);

·Offshore products and food contact materials (DK);

·Steel for the reinforcement of concrete and metal scaffolding (EL);

·Control equipment in the road transport sector (IT);

·Plant-protection products and packaging waste management (PT);

·Equipment for TV sets and precious metals (SE);

·End-of-life vehicles and passenger cars (UK).

4.3.1.5 Data gaps related to the market analysis and the CBA

The gaps of the market analysis related to:

·Data consistency and availability: some products included in the EC template are not covered by the NACE and/or PRODCOM classifications;

·Time frame: currently available Eurostat statistics – and namely SBS – used for the analysis at the sectoral level do not cover the entire time frame required by the ToR, namely 2008-2015 for all EU-28 Member States.

Given that the national reports were the main source of information for mapping costs and benefits, data gaps largely correspond to those listed above, and derive precisely from:

·Low availability of general and sectoral data, as some Member States did not provide the information corresponding to a number of sectors and/or indicators, or they provided qualitative rather than quantitative data (see Table 4-52 for an overview of sectoral and geographical coverage provided by national reports);

·Questionable data: some Member States reported values that do not seem reliable. For instance, the Bulgarian national authorities reported a budget available to MSAs in relative terms amounting to an average of 47.2% of the total national budget, while the Czech authorities reported values a budget available to MSAs around 92.6% of the total national budget;

·Unstructured data: some Member States provided data aggregated to correspond to multiple sectors, thereby compromising the analysis at sector level. Other Member States did not aggregate data at the national level, providing information only for some national MSAs;

·Unavailability of data about costs incurred by MS authorities for surveillance activities before 2008. These costs might allow for assessment of the costs deriving from the new obligations introduced by the Regulation.

·Unavailability of data about product compliance in the Single Market and injuries caused by product non-compliance. A potentially ineffective market surveillance might lead to relevant costs for economic operators, related to a lower product compliance and to unfair competition, as well as to reduced safety and user trust. There are no databases on this, except the European Injury Data Base (IDB). However, the IDB data currently available are produced voluntarily by Member States and do not clearly mention if notified injuries are caused by product non-compliance or by improper consumer use. Therefore, we used an online survey and targeted interviews to measure in a qualitative way if the measures taken by MSAs are proportionate to their objectives and effective in ensuring product compliance and a level playing field for businesses.

4.3.2    Data gaps in the field research

Some difficulties were encountered while performing the field research. In some cases, respondents felt overburdened by the many requests for information (e.g. public consultation, targeted surveys and interviews) despite the careful stakeholder targeting performed jointly with the EC.

As for the targeted surveys, the information requested was very detailed and stakeholders expressed the need for an extended deadline in order to provide more complete information. This implied a rescheduling of activities (e.g. interviews) that were specifically aimed at investigating issues emerging from the targeted surveys. Furthermore, the analysis revealed gaps in the contributions received from economic operators and civil society associations, as only four economic operators, three civil society associations and 12 industry associations participated. Consequently, these categories are under-represented in the targeted surveys’ results, although they were consulted extensively through interviews in the final phase of the study.

As for the interviews, a general lack of stakeholder willingness to participate was detected. In particular, it was difficult to identify the right person to interview for the case studies.

4.3.3    Solutions to the problems encountered 

The table below provides an overview of all problems encountered and solutions proposed.

Table 4-4 - Problems encountered and mitigation measures

Problems encountered

Mitigation measure

Lack of data on product non-compliance

RAPEX data and information from the national reports have been used to provide at least an idea of the dimension of the phenomenon. 

Lack of data on levels of overall resources available to MSAs:

·Data on budget are only available for a few sectors, or are presented as estimates;

·Impossible to disaggregate data on budget only related to market surveillance;

·Existence of too many authorities.

These data were cross-checked through the interviews.

In case of persisting limitations, these data were not included in the analysis.

Data expressed in national currency instead of euros

We used the European Central Bank average exchange rate for each year over the period 2010-2014.

Data expressed in terms of staff number instead of FTEs

We considered staff numbers as proxies for FTEs.

Lack of harmonisation in the programme year of reference

We assumed that national programmes are still comparable irrespective of the year of reference.

Information not always complete and harmonised since some MS did not follow the EC template at all and others only reported sector-specific information

We extrapolated information to gather the overall picture of market surveillance implementation at the national level.

National reports do not include data for all product sectors covered by the Regulation

Some hypotheses have been made concerning the correspondence between the EC template and NACE/ PRODCOM classifications, in order to obtain reliable sources of data for the analysis at both product and sector level.

Currently available Eurostat statistics do not allow for the time-frame coverage requested by the ToR

We have only selected the years with the highest availability of data, namely 2012-2014.

Lack of data on Germany

A case study was conducted on Germany.

Low quality of data for the CBA provided in the national reports that could not be solved by data gathered through the targeted surveys, which are not complete.

10 interviews were performed to collect data for the CBA.

5.    State of play

5.1    Market analysis

The market analysis was performed to estimate the value and volume of the products included in the scope of Regulation (EC) No 765/2008 (see Annex for tables of correspondence between the sector in scope of the Regulation and statistical classification used, i.e. NACE). This analysis has also been used to assess whether the extent of market surveillance activities is sufficient, given the market dimension.

5.1.1    Analysis at sectoral level

As shown in the figure below, from 2008 and 2014, around 1.2 million enterprises were operating within harmonised sectors, representing more than 65% of the total number of active enterprises in the manufacturing economy (around 1.8 million).

Figure 4-1 - Number of enterprises in harmonised sectors vs. overall manufacturing sectors (2008-2014, EU-28), millions, NACE Digit-2

Source: Authors’ elaboration on SBS (2016)

It is important to emphasise that since data are available at NACE division level (Digit 2 – NACE code), all results should be considered as an upper estimate, since some divisions might contain one or more classes for which there are no harmonised product rules.

A more precise estimate is available for 2012-2014; during this period, Eurostat provides data at NACE group level (Digit 3 – NACE code). In this case, the number of enterprises operating within the harmonised sectors is 0.91 million (53% of the total number of enterprises active in the manufacturing sectors).

Figure 4-2 - Number of enterprises in harmonised sectors vs. overall manufacturing sectors (2012-2014, EU-28), millions, NACE Digit-3

Source: Authors’ elaboration on SBS (2016)

It is very important to underline that around 78% of the enterprises operating within the harmonised sectors are micro-enterprises (i.e. with less than 9 employees) and 16.4% are small enterprises (i.e. with less than 50 employees).

Figure 4-3 - Size of enterprises operating in harmonised manufacturing sectors (2012- 2014, EU-28)

Source: Authors’ elaboration on SBS (2016)

Furthermore, more than 20 million people are employed in the harmonised sectors at the EU-28 level (i.e. around 81% of all people employed in the manufacturing sectors), with a quite insignificant variation over the period considered.

Figure 4-4 - Number of employees: harmonised sectors vs. overall manufacturing sectors (2008-2014, EU-28), millions, NACE Digit-2

Source: Authors’ elaboration on SBS (2016)

In this case, a better estimation is achieved by using available data at NACE Digit-3: 15.8 million people are employed in the harmonised sector, which correspond to 68.4% of all those employed in the manufacturing sectors.

Figure 4-5 - Number of employees: harmonised sectors vs. overall manufacturing sectors (2012-2014, EU-28), millions, NACE Digit-3

Source: Authors’ elaboration on SBS (2016)

The importance of harmonised sectors is more evident if wealth creation (i.e. value added and turnover) is considered. In particular, the value added produced in harmonised sectors increased by 6% during the period 2008-2014 (i.e. rising from €1.2 to 1.27 €billion) and its contribution to the overall value added of the manufacturing sectors increased from 84.6% in 2008 to 85.9% in 2014 ( Figure 4-6 ).

Figure 4-6 - Value added at factor cost: harmonised sectors vs overall manufacturing sectors (2008-2014, EU-28), €billion, NACE Digit-2

Source: Authors’ elaboration on SBS (2016)

In addition, considering the period 2012-2014, micro and SMEs operating in harmonised sectors contributed to 32% of the overall value added produced in the manufacturing economy (i.e. 373 billion out of €1,164 billion).

Table 4-5 - Value added at factor cost per size of enterprises: harmonised sectors vs. overall manufacturing sectors (2011-2013, EU-28)

Size of enterprises

Harmonised

sectors

Manufacturing

a/b

Total (a)

%

Total (€b)

%

%

Micro enterprises (0-9 employees)

49.02

6%

84.64

7%

4%

SMEs (10–249 employees)

323.54

38%

451.88

39%

28%

Large enterprises (> 249 employees)

488.56

57%

627.25

54%

42%

Total

861

100%

1,164 (b)

100%

74%

Source: Authors’ elaboration on SBS (2016)

Finally, relevant results also emerged in terms of turnover. As shown in the figure below, enterprises operating within harmonised sectors contribute to around 80% of the total value of market sales in manufacturing sectors (€4,469 billion out of €5,620 billion which corresponds to the overall turnover produced within the manufacturing sectors).

Figure 4-7 - Turnover: harmonised sectors vs. overall manufacturing sectors (2008-2014, EU-28), €b

Source: Authors’ elaboration on SBS (2016)

If the size of enterprises is considered, micro and SMEs active in harmonised sectors accounted for 27% (i.e. 3% plus 24%) of turnover generated within the entire manufacturing economy (€1,238 billion out of €4,564 billion).

Table 4-6 - Turnover per size of enterprises: harmonised sectors vs. overall manufacturing (2011-2013, EU-28)

Size of enterprises

Harmonised

sectors

Manufacturing

a/b

Total (€b)

(a)

%

Total (€b)

%

%

Micro enterprises (0-9 employees)

146.15

4%

251.03

5%

3%

SMEs (10-249 employees)

1,091.72

33%

530.30

34%

24%

Large enterprises (> 249 employees)

2,067.94

63%

2,782.93

61%

45%

Total

3,306.81

100%

4,564.26

100%

72%

Source: Authors’ elaboration on SBS (2016)

5.1.2    Analysis at product level

We have identified 1,850 harmonised products, representing around 46% of all products (around 4,000) included in the PRODCOM list.

The analysis at product level has been performed over the period 2008-2015.

In particular, the research, on average, value of harmonised products traded within the EU Internal Market was €2,478 billion during the period 2008-2014 ( Figure 4-8 and Figure 4-9 ).

Figure 4-8 - Value of harmonised products within the EU-28 (2008-2014), €bn

 

Source: Authors’ elaboration on PRODCOM – statistics by product, Eurostat (2016)

The value of harmonised products corresponds to around 69% of the overall value of manufacturing products traded. This value has been computed considering the following values for the identified harmonised products ( Figure 4-9 ):

Value of sold production – Value of extra EU exports + Value of extra EU imports.

To identify the economic sectors in which harmonised product rules are more relevant, the NACE codes used so far have been aggregated using the International Standard Industrial Classification of All Economic Activities (ISIC rev 4). 50  

The analysis shows ( Table 4-7 ) that 80% of harmonised products (€1,818 billion) are traded within the following sectors:

Basic metals and fabricated metal products (NACE codes 24 and 25)

·Chemicals and chemical products (NACE code 20);

·Rubber and plastics products, and other non-metallic mineral products (NACE codes 22 and 23);

·Computer, electronic and optical products (NACE code 26);

·Machinery and equipment (NACE code 28);

·Transport equipment (NACE codes 29 and 30).

Table 4-7 - Value of harmonised products per sector (ISIC rev 4/NACE rev.2)

ISIC rev 4

NACE rev 2

Average value (€b)

2008-2014

%

Manufacture of textiles, apparel, leather and related products

13 to 15

120.40

4.9%

Manufacture of wood and paper products, and printing

16 to 18

:

:

Manufacture of coke, and refined petroleum products

19

:

:

Manufacture of chemicals and chemical products

20

362.47

14.6%

Manufacture of pharmaceuticals, medicinal chemical and botanical products 51

21

103.16

4.2%

Manufacture of rubber and plastics products, and other non-metallic mineral products

22 + 23

324.72

13.1%

Manufacture of basic metals and fabricated metal products, except machinery and equipment

24 + 25

459.96

18.6%

Manufacture of computer, electronic and optical products

26

242.03

9.8%

Manufacture of electrical equipment

27

165.76

6.7%

Manufacture of machinery and equipment n.e.c.

28

309.13

12.5%

Manufacture of transport equipment

29 + 30

323.79

13.1%

Other manufacturing, and repair and installation of machinery and equipment

31 to 33

67.28

2.7%

Total

2,478.69

100%

Source: Authors’ elaboration on PRODCOM (2016)

Furthermore, 30% of the value of harmonised products (€756 billion on average over the period considered) is related to goods imported from non-EU countries (green bars in Figure 4-9 ).

Figure 4-9 - Trade in harmonised products: sold production and trade with non-EU countries (2008-2014, EU-28), €b

Source: Authors’ elaboration on PRODCOM – statistics by product, Eurostat (2016)

The relevance of harmonised products also emerges if intra-EU imports are considered. Eurostat statistics on international trade in goods 52  show that products for which harmonised product rules exist represent 66% ( Figure 4-10 ) of the value of the overall intra-EU imports of manufacturing goods (€1,183 billion). Annex 8.14 provides the value of intra-EU imports of harmonised products per Member State. 53

Figure 4-10 - Value of intra-EU imports: harmonised products vs. non-harmonised products (annual value and annual average 2008-2015, EU-28, €b)

Source: EU trade since 1998 by SITC, Eurostat (2016)

5.2    Implementation of the Regulation

This section is mainly descriptive and summarises the current situation in terms of structures relevant to implementation of Regulation (EC) No 765/2008, in particular: the organisation of market surveillance at the national level, market surveillance activities to detect non-compliant products, the existing coordination and cooperation mechanisms within/among Member States, and the measures taken against non-compliant products.

5.2.1    Organisation of market surveillance at the national level

5.2.1.1    Organisational models

According to Article 16(1) of the Regulation, “Member States shall organise and carry out market surveillance as provided for in this Chapter [i.e. on General requirements]”. The Regulation does not set explicit obligations on how market surveillance shall be organised at the national level, this being left to Member States’ prerogative. Therefore, market surveillance is organised differently at the national level in terms of sharing competences and powers between MSAs. Table 4-8  summarises the organisational structures in place in all EU Member States, as resulting from the national programmes and based on the classification provided by the European Parliament (2009). 54

Table 4-8 - Organisational structures for market surveillance in the EU-28 Member States

MS

Organisational structure for market surveillance

AT

Market surveillance is performed by Land or federal authorities depending on the legal provisions that apply. Federal authorities perform market surveillance in all the sectors covered by the New Approach, with a few exceptions, which is where the Lands are responsible. For instance, they are responsible for market surveillance in the pyrotechnics and explosives for civil use sectors. Finally, other national agencies carry out inspections in sectors such as radio and telecommunication equipment under R&TTE, and fertilisers.

BE

The Belgian Interministerial Economic Commission within the Federal Public Services coordinates market surveillance at the national level. Various federal government departments, agencies and institutes are responsible for market surveillance implementation.

BG

The Bulgarian State Agency for Metrological and Technical Supervision (DAMTN) is the main authority responsible for market surveillance of products covered by the New Approach Directives, except for medical devices and health-related products, the responsibility for which falls under the Executive Agency for Medicines (IAL) and the Regional Health Inspectorate (RZI). The Consumer Protection Commission (KZP) is responsible for consumer protection and for surveillance in the aerosol dispenser, tyre labelling, other products under GPSD, and textile and footwear labelling sectors, while the Technical Control Inspectorate (KTI) is responsible for agricultural and forestry machinery and the Regional Inspectorates for the Environment and Water (RIOSV) are responsible for fluorinated greenhouses gases and ozone-depleting products.

CY

Cyprus has a semi-decentralised market surveillance structure, whereby ministries and their departments are competent for a number of sectors covered by the Regulation. The Ministry of Labour, Welfare and Social Insurance and the Ministry of Transport, Communications and Works are responsible for the largest number of sectors (eight each).

CZ

The Czech Trade Inspection Authority carries out surveillance in 19 sectors. 55 Other authorities have sector-specific market surveillance responsibilities in the remaining sectors. For instance, the Ministry of Health performs controls on cosmetic products and the Rail Authority carries out market surveillance for cableway products.

DE

Germany has a regional market surveillance structure, as each of its 16 Lands is responsible for implementing market surveillance. Each has a competent ministry per sector. However, market surveillance responsibilities for some sectors are managed at the federal level. 56

DK

Denmark has a decentralised market surveillance structure as activities are divided between 11 authorities, each having expertise in a particular area. This structure, aimed at ensuring strong technical and specific skills, also implies that activities are managed in different ways depending on the competent authority and sector.

EE

Estonia has a semi-decentralised structure with seven MSAs established under four ministries. However, the Technical Regulatory Authority is the main authority responsible for carrying out market surveillance in 18 sectors.

EL

There are 10 MSAs. Eight are represented by the competent ministries and two are national agencies: the National Organisation for Medicines and the National Telecommunications & Post Commission (EETT). The Ministry of Economy, Development and Tourism and the Ministry of Development and Competitiveness are the main authorities as they are responsible for market surveillance of 13 and seven sectors, respectively.

ES

Market surveillance activities are coordinated by the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN). As Spain is organised into autonomous communities, the autonomous community authorities have executive powers in the field of consumer products. For the other sectors, national or regional authorities are responsible for market surveillance. SOIVRE (the Official Service of Surveillance, Certification and Technical Assistance of Foreign Trade) is involved in performing controls at the borders, checking products before their arrival to Customs’ offices.

FI

There are nine MSAs. Market surveillance is generally carried out at the national level. However, exceptions are market surveillance of a number of products for professional use (PPE, machinery, cableways, non-road mobile machinery) where the Department for Occupational Safety and Health at the Ministry of Social Affairs and Health as well as Regional State Administrative Agencies’ occupational health and safety areas carry out activities at the regional level.

FR

The Directorate-General for Competition, Consumer Affairs and Fraud Repression (DGCCRF) and the Directorate-General for Customs and Indirect Taxation (DGDDI) are responsible for market surveillance activities with cross-sectoral competences. However, other institutions contribute to market surveillance by performing specific checks or on-site services, such as the Directorate-General for Companies for Measuring Instruments, the Directorate-General for Risk Prevention, the Directorate for Maritime Affairs, and the National Agency for the Safety of Medicinal and Health Products.

HR

Market surveillance is organised according to the sectoral competences of six ministries. On 1 January 2014, the Ministry of the Economy took over the main market surveillance tasks – namely the protection of consumers, product safety and pressure equipment and the tasks of the mining and electricity inspectorate. Other relevant authorities are the State Office for Metrology (responsible for measuring instruments, non-automatic weighing instruments and pre-packaged products), the Ministry of the Interior (pyrotechnics), the Croatian Regulatory Authority for Network Industries - HAKOM (radio equipment and telecommunications terminal equipment), the Ministry of Agriculture (fertilisers) and the Ministry of Health (cosmetic products, toys and chemical products).

HU

Hungary has a decentralised market surveillance structure, made up of 14 MSAs. Market surveillance in a number of sectors is managed at national level by the competent agencies (e.g. National Media and Infocommunications Authority, Hungarian Trade Licensing Office) or by the competent government office. In most sectors, market surveillance activities are carried out at the regional level. 57  

IE

Overall, 19 government departments and state agencies are in charge of market surveillance. The Health and Safety Authority carries out surveillance in 11 sectors, although for some of these it is not the only responsible authority.

IT

Italy has a decentralised market surveillance structure, with eight ministries carrying out surveillance activities, helped by several national agencies and Customs depending on the sectors. Product safety controls within national borders are assigned to the Guardia di Finanza, while Customs are responsible for product checks at the border.

LT

The state non-food inspectorate performs market surveillance activities in 18 sectors covered by the Regulation, while 10 other MSAs (ministries or national agencies) share surveillance duties for a number of sectors covered by the Regulation.

LU

Market surveillance is mainly managed by the Institute for Standardisation, Accreditation, and the Safety and Quality of Products and Services (ILNAS). Like France, several ministerial departments and administrations are nonetheless responsible for specific market surveillance activities. The Ministry of Health, for instance, is responsible for the implementation of specific Directives in the field of health.

LV

There are 11 different authorities subordinated to seven different ministries. In addition, some market surveillance activities are performed by the Customs Board of the State Revenue Service and the State Police.

MT

Malta has a centralised market surveillance structure. In 2013, the Malta Competition and Consumer Affairs Authority (MCCAA) was set up, replacing the existing Malta Standards Authority and the Consumer and Competition Division. The former comprises the Regulatory Affairs Directorate, responsible for the transposition of European technical regulations and Directives into Maltese law, and the Market Surveillance Directorate (MSD-TRD), which is the sole MSA for Malta for non-food and non-medicinal products.

NL

There are six MSAs under different ministries, each performing surveillance on a different set of products covered by the Regulation. They are the Social Affairs and Employment Inspectorate (I-SZW), Human Environment and Transport Inspectorate (ILT), the Netherlands Radio-communications Agency (AT), Verispect B.V., Health Care Inspectorate (IGZ), and the Netherlands Food and Consumer Product Safety Authority (NVWA).

PL

Poland has 10 MSAs, some of which carry out market surveillance activities for a number of sectors while others have a specific area of competence. The Office of Competition and Consumer Protection (OCCP) supervising trade inspection, for instance, manages surveillance activities related to 14 sectors, 58 while the National Sanitary Inspection controls products in the cosmetic sector.

PT

Six authorities are responsible for the mainland’s market surveillance, while two MSAs (i.e. Regional Inspection of Economic Activities of the Azores - IRAE Açores - and Regional Inspection of Economic Activities of Madeira - IRAE Madeira) are responsible for market surveillance in the autonomous regions. In mainland Portugal, the authority for food and economic security performs activities and inspections in all sectors concerned by the Regulation, while the remaining five authorities carry out market surveillance in the other sectors covered by the Regulation (e.g. the National Communication Authority deals with products under the R&TTE). The Tax and Customs Authority, which is not considered an MSA, is responsible for border controls.

RO

Romania has 14 MSAs with sector-specific competences. These comprise 11 national agencies and institutions, the Ministry of Health and the Ministry of Agricultural and Rural Development and the State Inspectorate for Construction.

SE

Market surveillance is decentralised at sectoral level and is carried out by 16 MSAs affiliated to a total of seven ministries, each competent for a specific area of products, and 290 municipalities.

SI

There are nine MSAs – Market Inspectorate of the Republic of Slovenia (TIRS), Metrology Inspectorate, Health Inspectorate, Chemicals Office, Public Agency for Medicinal Products and Medical Devices (JAZMP), Labour Inspectorate, Internal Affairs Inspectorate (IRSNZ), Agriculture and Environment Inspectorate, Transport, Energy and Environment Inspectorate – subordinated to six ministries. The TIRS is the main authority in charge of the supervision of 15 sectors covered by the Regulation.

SK

Slovakia has a centralised market surveillance system in which the Slovak Trade Inspectorate is the main authority in charge of consumer protection for non-food products in the internal market. Other authorities, such as the Slovak Metrological Inspectorate and the National Labour Inspectorate, perform market surveillance related to specific products. Market surveillance for cosmetic products is enforced at both national and regional level, as the Public Health Authority of the Slovak Republic together with 36 Regional Public Health Authorities are the responsible authorities. Interestingly, products are divided into two groups – consumer products and products used by businesses – which means that some product categories fall under the responsibility of two different MSAs, depending on their final users.

UK

MSAs operate at national or regional level depending on the sector of competence. More than 200 UK local authorities (Trading Standards in Great Britain and District Councils in Northern Ireland) are responsible for ensuring the safety of consumer and construction products. The Health and Safety Executive (HSE) in Great Britain and the Health and Safety Executive for Northern Ireland (HSENI) are in charge of market surveillance related to the safety of goods for workplaces and linked aspects. Other national agencies are responsible for supervision in other sectors.

5.2.1.2    Resources available to MSAs at the national level

According to Article 18(3) of the Regulation, “Member States shall entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks.

5.2.1.2.1 Financial resources available for market surveillance activities

Data on the total budget available to MSAs in nominal terms, as reported in Figure 4-11 , indicate that the overall amount available at the EU level declined annually between 2010 and 2013. The figures refer to 18 EU Member States, excluding Austria, Cyprus, Estonia, Greece, Croatia, Luxembourg, Slovenia and the United Kingdom which have not included these data in their national reports. Moreover, Hungary only reported values since 2011, and Sweden reported incomplete data for 2010 and 2011. Therefore, they were not considered as the lack of data for 2010 and 2011 would have created a different perspective on the 2010-2013 trends.

Figure 4-11 - Total budget available to 19 MSAs in nominal terms during 2010-2013, €m

 

Source: Authors’ elaboration on national reports

As suggested by the study’s Steering Committee, the declared budget should reflect all financial resources assigned to market surveillance and enforcement activities, including related infrastructures and projects and measures aimed at ensuring economic operators’ compliance with product legislation. These measures range from communication activities (consumer/business information and education) to enforcement, and should include the remuneration of staff, direct costs of inspections, laboratory tests, training, and office equipment costs. Enforcement activities at regional/local level should also be reported. However, national reports do not always specify the methodology used to measure costs and types of costs included. As a result, some inconsistencies appear across countries and throughout the years for which data are available (2010-2013).

At the national level, during 2010-2013, information analysed shows that:

·More than 80% of the total budget available to the 18 MSAs reporting data in nominal terms is concentrated in seven Member States ( Figure 4-12 );

·More than half of the Member States providing data had an available annual budget of less than €10 million ( Figure 4-13 );

·Only three countries (Portugal, the Netherlands and Spain) declared an annual budget allocated to market surveillance activities equal to or greater than €20 million ( Figure 4-13 ).

Figure 4-12 - Contribution of each MS to the total budget available in nominal terms to MSA at EU level from 2010-2013

Source: Authors’ elaboration on national reports

Figure 4-13 - Annual budget available to MSAs in nominal terms, average 2010-2013, €M

Source: Authors’ elaboration on national reports

As shown in  Figure 4-14 , over the period considered the total budget allocated annually to market surveillance activities increased in eight Member States 59 and decreased in seven. 60 In other countries (Ireland, the Netherlands and Lithuania) the budget remained stable over the period 2010-2013. The magnitude of reduction and increase in the total budget available to national MSAs also differs. On a three-dimension scale (0-10% – limited, 10-30% – moderate, 40-50% – high) the variations in total budget (both in positive and negative terms) was:

·High in two Member States (Belgium -32% and Latvia +40.5%);

·Moderate in five Member States (increase in Romania and Poland, reduction in Bulgaria, Spain and Portugal);

·Limited in more than half the Member States, i.e. in 12 out of 18.

Figure 4-14 – Variation (%) in the average annual budget available to MSAs in nominal terms 2010-2013, €M

Source: Authors’ elaboration on national reports

5.2.1.2.2 Human resources available for market surveillance activities

The staff resources available to MSAs (FTE units) are relevant for measuring enforcement costs incurred by MSAs. A reduction in number can also be observed here ( Figure 4-15 ), potentially as a result of the budget decrease discussed above. Consequently, the costs incurred by MSAs to enforce the Regulation in terms of FTEs were lower in 2013 compared to 2010. The analysis considered 19 Member States, since data on the other were not available over the entire period; as stated before, Hungary did not provide all the necessary data.

Figure 4-15 – Total staff resources available to MSAs (FTE units) during 2010-2013 at EU level 61

Source: Authors’ elaboration on national reports

The analysis at the Member State level of the total number of staff resources available to MSAs (FTE units) revealed the following:

·On average, 7,741 staff resources (FTEs) were available for the MSAs of 18 EU Member States during the period 2010-2013 ( Figure 4-15 );

·86.3% of staff resources (6,679) were based in seven Member States (Poland, Estonia, Czech Republic, Portugal, Romania, Slovakia and Bulgaria, Figure 4-17 and Figure 4-18);

·More than 30% of total staff resources were based in one country (Poland, Figure 4-17 and Figure 4-18);

·There were significant differences among countries in terms of total staff resources available over the period 2010-2013. On the one hand, a large number of Member States (15 out of 18) involve less than 1,000 FTEs in market surveillance activities. On the other hand, Poland reported a significantly greater number of FTEs available to the MSAs, more than five times higher than staff resources declared by most countries.

Figure 4-16 – Total staff resources available to MSAs at country level (average 2010-2013), FTEs

 Source: Authors’ elaboration on national reports

Figure 4-17 – Total staff resources available to MSAs (FTE units) per country over 2010-2013

 

Source: Authors’ elaboration on national reports

The highlights of the analysis concerning the variation in total staff resources available to MSAs (FTE units) over the period 2010-2013 include ( Figure 4-18 ):

·More than half of the Member States considered (11) displayed a relatively stable trend in the number of staff resources available to MSA (FTE units) with a variation of less than 5% of the value registered in 2010;

·Three Member States (Latvia, Lithuania and Belgium) declared an increase between 12.2% and 16.3%;

·The magnitude of total staff reduction was very different: the largest percentage decrease (-60.6% - Luxembourg) was almost twice as high as the second largest percentage reduction (33.3% - Spain) and 202 times higher than the smallest reduction (0.3% - Ireland).

Figure 4-18 – Variation in total staff resources available to MSAs (FTE units) over 2010-2013

 

Source: Authors’ elaboration on national reports

While at the EU level the budget available for market surveillance activities experienced continuous adjustments and the total staff resources available to MSAs (FTE units) registered a negative trend, the number of inspectors (FTE units) followed a fluctuating trend (falling one year, rising in the next, then falling again) which could be translated into fluctuating staff costs during this period ( Figure 4-19 ). In this case, only 16 Member States provided completed data and were included in the analysis. 62

Figure 4-19 - Total number of inspectors available to MSAs (FTE units) over 2010-2013 at EU level

 

Source: Authors’ elaboration on national reports

Figure 4-20 - Total number of inspectors (FTE units) available to MSAs per country over 2010-2013

 

Source: Authors’ elaboration on national reports

Regarding the total number of inspectors (FTE units) available to MSAs over 2010-2013 at the country level, the following data emerged:

·On average, 4,506 inspectors were available to the 16 Member States considered for inspection activities ( Figure 4-19 );

·The majority (90%) of inspectors (4,019) were based in six Member States - Poland, Italy, Czech Republic, Romania, Portugal and Slovakia ( Figure 4-20 );

·Around half (2,372) of the FTEs dedicated to inspection activities were employed in two Member States (Poland and Italy);

·The magnitude of the costs derived from the number of inspectors (FTE units) varies across for instance, in Luxembourg and Lithuania (included in the ‘Others’ category in Figure 4-20 ) only 4.6 and 21.74 FTEs, respectively, were allocated to market surveillance activities, while Poland involved 5,822 FTEs.

Figure 4-21 - Variation in total number of inspectors (FTE units) available to MSAs per year, during 2010-2013

Source: Authors’ elaboration on national reports

At the country level, analysis of the change in the number of inspectors available to MSAs annually reflects the following:

·In most Member States (10 out 16) the number of inspectors fell;

·Six countries (Bulgaria, Italy, Denmark, Estonia, Finland and Romania) had relatively stable trends, with the increase or decrease in the number of inspectors no higher than 5% of the number of inspectors available to MSAs in 2010;

·A significant increase (263.8%) was registered in Ireland.

With the exception of two Member States (Ireland and Poland), the overall trend in the total inspectors available to MSAs during the four years considered tends to be aligned with that for the total staff available to MSAs.

5.2.1.2.3 Technical resources

In relation to technical resources in particular, many MSAs 63 do not have their own laboratories for product testing in a large number of sectors (i.e. more than 20), and thus outsource these activities to accredited laboratories. However, some MSAs do have in-house test laboratories. Based on the available data, MSAs in Germany and Bulgaria have test facilities for most sectors covered by the scope of the Regulation (i.e. 27 and 18 sectors, respectively). Table 4-9 below presents an overview of test laboratories available in each Member State.

Table 4-9 – National MSA laboratories across Member States 64

MS

Number of sectors where MSAs have own test laboratories

Number of sectors where MSAs do not have own test laboratories

Number of sectors for which no info was available

DE

27

0

6

BG

18

14

1

CZ

13

19

1

NL

12

12

9

PL

10

23

0

HR

7

22

4

LU

6

26

1

EE

5

21

7

RO

5

28

0

UK

4

19

10

CY

3

23

7

SE

3

28

1

FI

2

24

7

LV

1

26

6

SI

1

32

0

DK

0

18

15

IE

0

33

0

Source: Targeted surveys

There are also differences across sectors. For instance, the electrical equipment under EMC, radio and telecom equipment under R&TTE – RED, cosmetics and toys are sectors where in-house laboratories are available, although only in a few Member States (i.e. either 8 or 7). In contrast, very few MSAs have in-house laboratories in the PPE, construction products, aerosol, simple pressure equipment, and lifts sectors.

Table 4-10 - National MSA laboratories across sectors 65

Sector

Number of MS where MSAs have test laboratories

Number of MS where MSAs do not have test laboratories

Number of MS for which no info was available

2. Cosmetics

8

6

14

18.Electrical equipment under EMC

8

10

10

19.Radio and telecom equipment under R&TTE - RED

8

11

9

3.Toys

7

12

9

17.Measuring instruments

7

11

10

15.Explosives for civil uses

6

10

12

20.Electrical appliances and equipment under LVD

6

13

9

21.Electrical and electronic equipment under RoHS and WEEE and batteries

6

11

11

22.Chemicals

6

10

12

12.Noise emissions for outdoor equipment

5

11

12

31.Biocides

5

11

12

4.PPE

4

16

8

9.Machinery

4

14

10