(1)

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety  (3) lays down the fundamental requirement for products on the internal market that consumer products must be safe and that Member States' market surveillance authorities must take efficient action against dangerous products as well as exchange information to that effect through the Community Rapid Information System (RAPEX). Directive 2001/95/EC needs to be fundamentally revised to improve its functioning and to ensure consistency with developments in Union legislation as regards market surveillance, obligations of economic operators and standardisation. In the interest of clarity, Directive 2001/95/EC should be repealed and replaced by this Regulation. [Am. 1]

(2)

A regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for divergent transposition and application by Member States. A regulation ensures that legal requirements are applicable at the same time throughout the Union. [Am. 2]

(3)

This Regulation must contribute to the attainment of the objectives referred to in Article 169 of the TFEU. In particular it should aim at ensuring the functioning of the internal market as regards products intended for consumers by laying down uniform rules regarding a general In order to ensure a high level of consumer protection, the Union should contribute to protecting the health and safety requirement, assessment criteria and obligations of economic operators. Given that rules on market surveillance, including rules on RAPEX, are laid down in Regulation (EU) No […/…] [ on market surveillance of products ]  (4) which applies also to of consumers. In that regard, this Regulation is essential to delivering the fundamental aim of an internal market for safe products covered by this Regulation, no further provisions on market surveillance or RAPEX are needed in this Regulation , whilst contributing to the attainment of the objectives referred to in Article 169 of the Treaty on the Functioning of the European Union (TFEU) . [Am. 3]

(3a)

This Regulation should aim in particular to ensure the functioning of the internal market as regards products intended for consumers, by laying down uniform rules regarding a general safety requirement, assessment of the safety of products criteria and the obligations of economic operators. Given that rules on market surveillance, including rules on RAPEX, are laid down in Regulation (EU) No …/… of the European Parliament and of the Council  (5)  (*1) , no further provisions on market surveillance or RAPEX are necessary in this Regulation. [Am. 4]

(3b)

The safety of consumers depends to a great extent on the active enforcement of Union product safety requirements. Market surveillance activities at national and Union level should be improved on an on-going basis and should be increasingly effective in order to meet the ever-changing challenges of a global market and a progressively complex supply chain. Failing market surveillance systems could generate a distortion of competition, jeopardise consumer safety and undermine citizens' trust in the internal market. The Member States should, therefore, establish systematic approaches to ensure the increasing effectiveness of market surveillance and other enforcement activities and should ensure their openness to the public and to interested parties. [Am. 5]

(4)

Union legislation on food, feed and related areas sets up a specific regime ensuring the safety of the products covered by it. This Regulation should therefore not apply to those products with the exception of materials and articles intended to come into contact with food insofar as risks are concerned that are not covered by Regulation (EC) No 1935/2004 of the European Parliament and of the Council (6) or by other food specific legislation which only covers chemical and biological food related risks.

(5)

Medicinal products are subject to a pre-market assessment that includes a specific risk-benefit analysis. They should therefore be excluded from the scope of this Regulation.

(6)

This Regulation should not cover services. However, in order to secure the attainment of the protection of health and safety of consumers, it should apply to all products that are used, supplied or made available to consumers in the context of the provision of services, including products to which consumers are directly exposed during the provision of a service. Equipment on which consumers ride or travel which is operated by a service provider should be excluded from the scope of this Regulation since it has to be dealt with in conjunction with the safety of the service provided by a service provider . [Am. 6]

(6a)

Products which are designed exclusively for professional use but which have subsequently migrated to the consumer market should be subject to this Regulation because they can pose risks to the health and safety of consumers when used under reasonably foreseeable conditions. [Am. 7]

(6b)

Equipment on which consumers travel which is operated by a service provider should be excluded from the scope of this Regulation since it has to be dealt with in conjunction with the safety of the service provided. [Am. 8]

(7)

Despite the development of sector-specific Union harmonisation legislation that addresses safety aspects of specific products or categories of products, it is practically impossible to adopt Union legislation for all consumer products that exist or may be developed. There is therefore still a need for a legislative framework of a horizontal nature to fill gaps and ensure consumer protection not otherwise ensured, in particular with a view to achieving a high level of protection of health and safety of consumers, as required by Articles 114 and 169 TFEU.

(8)

In respect of the consumer products subject to this Regulation, the scope of application of the different parts of it should be clearly delimited from sector-specific Union harmonisation legislation. Whilst the general product safety requirement and related provisions of Chapter I of this Regulation should be applicable to all consumer products, the obligations of economic operators should not apply where Union harmonisation legislation includes equivalent obligations, such as Union legislation on cosmetics, toys, electrical appliances or construction products. [Am. 9]

(9)

In order to ensure consistency between this Regulation and sector-specific Union harmonisation legislation with regard to specific obligations of economic operators, the provisions concerning manufacturers, authorised representatives, importers and distributors should be based on the reference provisions included in 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  (7). Nevertheless, Union harmonisation legislation should not impose unnecessary administrative burdens on economic operators . [Am. 10]

(10)

The scope of this Regulation should not be limited to any selling technique of consumer products, and should therefore also cover distance selling , such as electronic selling, online sales and sales platforms . [Am. 11]

(11)

This Regulation should apply to second hand products that re-enter the supply chain in the course of a commercial activity, provided that they have been placed on the market as such, and to second-hand products originally placed on the market after the entry into force of this Regulation, except for those second-hand products for which the consumer cannot reasonably expect that they fulfil state-of-the art safety standards, such as antiques. [Am. 12]

(12)

This Regulation should also apply to, and thus prohibit the marketing, import, manufacture and export of, consumer products which, although not foodstuff, resemble foodstuff and are likely to be confused with foodstuff in a way that consumers, especially cause persons, in particular young children, may , to confuse them with foodstuff and consequently to place them in their mouths, suck or ingest them, which might by doing so may cause, for example, suffocation, poisoning, the perforation or obstruction of the digestive tract death or personal injury . Those imitations of foodstuffs have so far been regulated by Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers  (8) which should be repealed. [Am. 13]

(13)

The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics , composition, authenticity, materials, components, and presentation of the product and its packaging as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled. [Am. 14]

(13a)

The precautionary principle, as laid down in Article 191(2) TFEU and outlined inter alia in the Commission Communication of 2 February 2000 entitled ‘On the precautionary principle’, is a fundamental principle for the safety of products and for the safety of consumers and should be taken into due account when laying down the criteria for assessing the safety of a product. [Am. 15]

(13b)

This Regulation should take into account ‘child-appealing products’ whose design, packaging and characteristics in any way resemble a toy or an object appealing to or intended for use by children. Child-appealing products should furthermore be assessed for their levels of risk and appropriate action to mitigate that risk should be taken. [Am. 16]

(13c)

When assessing the safety of a product, special consideration should be given if the product has caused injuries notified into the Pan-European Injury Database established pursuant to Regulation (EU) No …/…  (*2) . [Am. 17]

(14)

To avoid overlapping safety requirements and conflicts with other Union legislation, a product which conforms to sector-specific Union harmonisation legislation that aims at the protection of health and safety of persons should be presumed to be safe under this Regulation.

(15)

Economic operators should be responsible for the compliance of products, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the health and safety of consumers. In that regard, there should be a strict alignment of the provisions regarding obligations of economic operators contained in Decision No 768/2008/EC, since this will provide a level playing field between the obligations on economic operators covered by Union harmonisation legislation and those covered by non-harmonised legislation under this Regulation. [Am. 20]

(15a)

In the case of products that are not subject to Union harmonisation legislation, European standards or national legislation on health and safety requirements, economic operators should assess the safety of products in accordance with specific criteria, on which basis they should define the level of risk associated with a product. Market surveillance authorities may assist economic operators in carrying out the safety assessment. [Am. 21]

(15b)

To make it easier to place safe products on the market, economic operators, in particular small and medium-sized enterprises (SMEs), should be able to meet their obligations under this Regulation by establishing consortia with the dual purpose of ensuring compliance with product safety requirements and high-quality standards and reducing the costs and ‘red tape’ with which individual businesses are burdened. [Am. 22]

(16)

All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that they only make available on the market products which are safe and in conformity with this Regulation. It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution process.

(16a)

Manufacturers should ensure that the products they place on the market have been designed and manufactured in accordance with the safety requirements laid down in this Regulation. In order to clarify the obligations of the manufacturer and to minimise the related administrative burdens, the Commission should establish a Union general risk assessment methodology for products and create user-friendly electronic tools for analysing risks. That methodology should establish an efficient tool for risk assessment that the manufacturers can use when designing products, by building on best practices and input from stakeholders. [Am. 23]

(16b)

In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address. [Am. 24]

(17)

Importers bear the responsibility that products originating from third countries that they place on the Union market comply with the requirements of this Regulation. The specific obligations of importers should therefore be included in this Regulation.

(18)

Distributors make products available on the market after they have been placed on the market by the manufacturer or the importer and should act with due care to ensure that their handling of the product does not adversely affect the compliance of the product with this Regulation.

(18a)

The distributor should ensure that the manufacturer and the importer have complied with their obligations, that is to say verifying the indication on the product or on its packaging of the name, model name, brand name or address at which the manufacturer and the importer can be contacted and the affixing of the manufacturer's batch number, serial number or other element on the product for its identification. The distributor should not check each product individually, unless the distributor considers that the manufacturer or the importer have not fulfilled their obligations. [Am. 25]

(19)

Any economic operator that either places a product on the market under his own name or trade mark or modifies a product in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.

(20)

Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective action against unsafe products, such as targeted recalls. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer and, if applicable, of the importer. Manufacturers should also establish technical documentation regarding their products for which they may choose the most appropriate and cost-efficient way such as by electronic means. Moreover, economic operators should be required to identify the operators who supplied them and to whom they supplied a product. Directive 95/46/EC of the European Parliament and of the Council (9) is applicable to the processing of personal data for the purposes of this Regulation.

(20a)

Globalisation, increased outsourcing and the growth in international trade mean that more products are being traded on markets across the world, and in that regard a close cooperation between global regulators and other stakeholders in the area of consumer product safety is essential to addressing the challenges of complex supply chains and higher volumes of trade. In particular, the Commission should be encouraged to strengthen the attention to safety by design of products through bilateral cooperation with the market surveillance authorities of third countries. [Am. 26]

(20b)

The current traceability systems and identification procedures already in place should be effectively enforced and improved. In that regard, assessments and evaluations on the use of the technologies in place are necessary to ensure better performance and lower the administrative burden on economic operators. One of the objectives of this Regulation is to constantly improve the traceability systems imposed on economic operators and products. [Am. 27]

(20c)

In order to improve traceability in the future, the Commission should assess how to facilitate the application of specific track-and-trace technologies and product authentication technologies. In that assessment, the technologies assessed should ensure inter alia consumer product safety, improve tracing mechanisms and avoid putting unnecessary administrative burdens on economic operators in order to prevent the costs thereof from being passed on to consumers. [Am. 28]

(20d)

Building on the establishment of national contact points pursuant to Regulation (EC) No 764/2008 of the European Parliament and of the Council  (10) , Product Safety Contact Points should function as information centres in the Member States for economic operators in order for those operators to receive guidance and training on product safety requirements and legislation. [Am. 29]

(21)

The indication of origin supplements is a necessary supplement to the basic traceability requirements laid down in this Regulation concerning the name and address of the manufacturer. In particular Furthermore , the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or , in particular where its given address is different from the actual place of manufacture , where the name and address of the manufacturer is missing altogether or where the address was on the packaging that has been lost . Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow-up actions. [Am. 30]

(21a)

The indication of origin of the product would make it easier for consumers to access information about the product chain, thereby increasing their level of awareness. In particular, when indicating the name of the manufacturer fulfilling the obligations of the economic operators, there is a risk of misleading the consumers since an indication of the manufacturer does not necessarily enable the consumer to establish what the country of production is. Thus, the indication of origin should be the sole means by which the consumers would be able to establish the country of production of a product. [Am. 31]

(21b)

In several jurisdictions of the trade partners of the Union, the indication of origin is mandatory in product labelling and custom declarations. The introduction of the indication of origin pursuant to this Regulation will bring the Union into line with the international trade regime. Furthermore, since the requirement to provide an indication of origin covers all non-food products on the territory of the Union, whether imported or not, it will comply with the international trade obligations of the Union. [Am. 32]

(22)

In order to facilitate the effective and consistent application of the general safety requirement set out in this Regulation, it is important to make use of European standards covering certain products and risks in such a way that a product which conforms to such a European standard, the reference of which has been published in the Official Journal of the European Union, is to be presumed to be in compliance with that requirement.

(23)

Where the Commission identifies a need for a European standard ensuring compliance of certain products with the general safety requirement under this Regulation, it should apply the relevant provisions of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (11) to request one or several European standardisation organisations to either draft or identify a standard which is suitable to ensure that products which conform to it are presumed to be safe. The references of such European standards should be published in the Official Journal of the European Union.

(24)

The procedures to request European standards in support of this Regulation, and on formal objections against them, should be laid down in this Regulation and be aligned with Regulation (EU) No 1025/2012. To ensure overall consistency in European standardisation issues, requests for European standards, or objections to a European standard, should therefore be brought before the committee set up by that Regulation, after appropriate consultation of experts of the Member States in the field of consumer product safety and of relevant stakeholders . [Am. 33]

(25)

European standards, the references of which have been published in accordance with Directive 2001/95/EC, should continue providing presumption of conformity with the general safety requirement. Standardisation mandates issued by the Commission in accordance with Directive 2001/95/EC should be deemed standardisation requests issued in accordance with this Regulation.

(26)

Where no relevant European standards or other recognised means to assess the safety of products exist, the assessment of product safety should take into account Commission recommendations adopted for that purpose pursuant to Article 292 TFEU.

(26a)

In order to maintain a high level of health and safety of consumers, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to determine the products, categories or groups of products for which the name, registered trade name or registered trade mark and address of the manufacturer and of the importer does not need to be indicated on the product itself due to the low level of risk related to such products, to determine the products, categories or groups of products bearing a potential serious risk to health and safety of persons and to specify the data which economic operators are to collect and store by means of traceability system. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(27)

In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the exemption to the obligation to inform market surveillance authorities about products presenting a risk, as regards the type of data carrier and its placement on the product for the purposes of the traceability system, as regards standardisation requests to European standardisation organisations and as regards decisions on formal objections to European standards. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12).

(28)

The advisory procedure should be used for the adoption of implementing acts as regards decisions on formal objections to European standards and where the references to the European standard concerned have not yet been published in the Official Journal of the European Union, given that the relevant standard has not yet led to the presumption of conformity with the general safety requirement laid down in this Regulation.

(30)

Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are implemented. Those penalties must be effective, proportionate and dissuasive and depend on the seriousness, duration and intentional or recurring character of the infringement, as well as the size of the undertakings, in terms of the number of persons employed by and annual turnover of the economic operators concerned, with particular regard to SMEs. Infringements should entail administrative penalties that are harmonised at Union level. Member States should be encouraged to allocate the revenues collected from such penalties to market surveillance activities . [Am. 34]

(30a)

In order to enhance the deterrent effect of the penalties, the Commission should make them public. In addition, economic operators who are repeatedly found to have intentionally breached this Regulation should be placed on a public, Union-wide blacklist. [Am. 35]

(31)

To allow economic operators, Member States and the Commission to adapt to the changes introduced by this Regulation, it is appropriate to provide for a sufficient transitional period until the requirements of this Regulation are applicable.

(32)

Since the objective of this Regulation, namely to ensure the proper functioning of the internal market as regards products intended for consumers whilst maintaining a high level of health, safety and consumer protection, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(33)

This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular this Regulation seeks to ensure full respect for the obligation to ensure a high level of human health protection and consumer protection as well as full respect for the freedom to conduct business,

(a)

which are intended for consumers;

(b)

which are likely, under reasonably foreseeable conditions, to be used by consumers even if , when placed on the market, they were not intended for them; products are not likely to be used by consumers if they are intended for the exclusive use by professionals and are explicitly labelled and presented as such; [Am. 40]

(c)

to which consumers are exposed are provided to a consumer in the context course of a service provided to them , whether or not the product is used by the consumer himself . [Am. 41]

(a)

medicinal products for human or veterinary use;

(b)

food;

(c)

materials and articles intended to come into contact with food insofar as risks related to those products are covered by Regulation (EC) No 1935/2004 or other Union legislation applicable to food;

(d)

feed;

(da)

medical devices as defined in Council Directive 90/385/EEC  (13) , Council Directive 93/42/EEC  (14) and Directive 98/79/EC of the European Parliament and of the Council  (15) ; [Am. 43]

(e)

living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction;

(f)

animal by-products and derived products;

(g)

plant protection products;

(h)

equipment on which consumers ride or travel which is operated by a service provider within the context of a service provided to consumers;

(i)

antiques;

(ia)

construction products as defined in Regulation (EU) No 305/2011 of the European Parliament and of the Council  (16) . [Am. 44]

(1)

‘safe product’ means any authentic product which is compliant with Union harmonisation legislation relating to health and safety. In the absence of such legislation it means any product which , under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of the use and, where applicable, its putting into service, installation and, maintenance , training and supervision requirements, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of persons; [Am. 45]

(1a)

‘product model’ means products that are considered to be distinct in terms of presenting identical or similar essential characteristics, with differences, if any, having no impact on their safety level unless otherwise proven by the manufacturer or the importer; [Am. 46]

(2)

‘making available on the market’ means 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;

(3)

‘placing on the market’ means the first making available of a product on the Union market;

(4)

‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured and markets that product under his name or trade mark;

(5)

‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;

(6)

‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;

(7)

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;

(8)

‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(9)

‘international standard’ means an international standard as defined in point (a) of Article 2(1) of Regulation (EU) No 1025/2012;

(10)

‘European standard’ means a European standard as defined in point (b) of Article 2(1) of Regulation (EU) No 1025/2012;

(11)

‘national standard’ means a national standard as defined in point (d) of Article 2(1) of Regulation (EU) No 1025/2012;

(12)

‘European standardisation organisation’ means a European standardisation organisation as defined in Article 2(8) of Regulation (EU) No 1025/2012;

(13)

‘market surveillance authority’ means a market surveillance authority as defined in point 12 of Article 3 of Regulation (EU) No …/… (*4);

(14)

‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;

(15)

‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being further made available on the market;

(16)

‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

(17)

‘serious risk’ means a any serious risk requiring rapid intervention and follow-up, including cases where those the effects may of which are not be immediate , requiring rapid intervention by the public authorities . [Am. 47]

(a)

as regards the risks covered by requirements designed to protect human health and safety laid down in or pursuant to Union harmonisation legislation, if it conforms to those requirements;

(aa)

if it is authentic, meaning that the product or any presentation of the product does not bear a trade mark without the authorisation of the trade mark owner that is identical or similar to a registered trade mark for that product, thereby misleading consumers as to the true identity of the product; [Am. 49]

(b)

in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a) of this Article, as regards the risks covered by European standards, if it conforms to relevant European standards or parts thereof, the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17;

(c)

in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a) and European standards referred to in point (b), as regards the risks covered by health and safety requirements laid down in the law of the Member State where the product is made available on the market, if it conforms to complies with such national requirements rules provided that they comply with Union law . [Am. 50]

(a)

the characteristics of the product, including its authenticity, composition, packaging, instructions for assembly and, where applicable, for installation and maintenance; [Am. 51]

(b)

the effect on other products, where it is reasonably foreseeable that it will be used with other products;

(c)

the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product;

(d)

the categories characteristics of consumers at risk when using the product under reasonably foreseeable conditions , in particular vulnerable consumers; [Am. 52]

(e)

the appearance of the product and in particular where a product:

(a)

the state of the art and technology; [Am. 54]

(aa)

reasonable consumer expectations concerning safety in terms of the nature, composition and intended use of the product; [Am. 55]

(b)

European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17;

(ba)

the essential requirements contained in the standardisation requests to European standardisation organisations in accordance with Article 16 as long as the Commission has not yet published the references of the harmonised standards in the Official Journal of the European Union; [Am. 56]

(c)

international standards;

(d)

international agreements;

(e)

Commission recommendations or guidelines on product safety assessment;

(f)

national standards drawn up in the Member State in which the product is made available;

(g)

product safety codes of good practice in force in the sector concerned;

(ga)

if the product, categories or groups of products, have caused injuries notified into the Pan-European Injury Database established pursuant to Regulation (EU) No …/…  (*5) ; [Am. 57]

(h)

reasonable consumer expectations concerning safety. [Am. 58]

(ha)

the state of the art and technology. [Am. 59]

(a)

a general description of the product and its essential properties relevant for assessing the product's safety;

(b)

an analysis of the possible risks related to the product and the solutions adopted to eliminate or mitigate such risks, including the outcome of any tests conducted by the manufacturer or by another party on his behalf;

(c)

where applicable, a list of the European standards referred to in point (b) of Article 5 or health and safety requirements laid down in the law of the Member State where the product is made available on the market referred to in point (c) of Article 5, or other aspects referred to in Article 6(2), applied to meet the general safety requirement laid down in Article 4.

(a)

further to a  reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product; [Am. 71]

(b)

cooperate with the market surveillance authorities, at their request, on any action taken to eliminate the risks posed by products covered by their mandate.

(a)

only a limited number of well-identified products are not safe;

(b)

the manufacturer, importer or distributor can demonstrate that the risk has been fully effectively controlled and cannot any more endanger so as to prevent any dangers to the health and safety of persons; [Am. 79]

(c)

the cause of the risk of the product is such that knowledge of it does not represent useful information for the authorities or the public. [Am. 80]

(a)

any economic operator who has supplied them with the product;

(b)

any economic operator to whom they have supplied the product.

(a)

determining the products, categories or groups of products susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1 of this Article. The Commission shall state in the delegated acts concerned if it has used the risk analysis methodology provided for in Commission Decision 2010/15/EU  (18) or, if that methodology is not appropriate for the product concerned, it shall give a detailed description of the methodology used ; [Am. 84]

(b)

specifying the data which economic operators shall collect and store by means of the traceability system referred to in paragraph 2 of this Article.

(a)

the cost-effectiveness of the acts, including their impact on businesses in particular SMEs;

(b)

the compatibility with traceability systems available at international level.

(a)

the technical rules applicable to a specific type of product on the territory in which those Product Safety Contact Points are established and information as to whether that type of product is subject to a requirement for prior authorisation under the laws of their Member State, together with information concerning the principle of mutual recognition as provided for in Regulation (EC) No 764/2008 and the application of that Regulation in the territory of that Member State;

(b)

the contact details of the competent authorities within that Member State by means of which they may be contacted directly, including the particulars of the authorities responsible for supervising the implementation of the technical rules in question in the territory of that Member State;

(c)

the remedies generally available in the territory of that Member State in the event of a dispute between the competent authorities and an economic operator.

(a)

to publish, not to publish or to publish with restriction the references to the European standard concerned in the Official Journal of the European Union;

(b)

to maintain, to maintain with restriction or to withdraw the references to the European standard concerned in or from the Official Journal of the European Union.