This document is an excerpt from the EUR-Lex website
Document 02019R1020-20240218
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance)Text with EEA relevance
Consolidated text: Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance)Text with EEA relevance
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (Text with EEA relevance)Text with EEA relevance
02019R1020 — EN — 18.02.2024 — 001.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
|
REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169 25.6.2019, p. 1) |
Amended by:
|
|
|
Official Journal |
||
|
No |
page |
date |
||
|
REGULATION (EU) 2023/1542 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 July 2023 |
L 191 |
1 |
28.7.2023 |
|
REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 20 June 2019
on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011
(Text with EEA relevance)
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
Article 2
Scope
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘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;
‘placing on the market’ means the first making available of a product on the Union market;
‘market surveillance’ means the activities carried out and measures taken by market surveillance authorities to ensure that products comply with the requirements set out in the applicable Union harmonisation legislation and to ensure protection of the public interest covered by that legislation;
‘market surveillance authority’ means an authority designated by a Member State under Article 10 as responsible for carrying out market surveillance in the territory of that Member State;
‘applicant authority’ means the market surveillance authority that makes a request for mutual assistance;
‘requested authority’ means the market surveillance authority that receives a request for mutual assistance;
‘non-compliance’ means any failure to comply with any requirement under the Union harmonisation legislation or under this Regulation;
‘manufacturer’ means any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark;
‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;
‘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;
‘fulfilment service provider’ means any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council ( 1 ), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council ( 2 ), and any other postal services or freight transport services;
‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation;
‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;
‘information society service provider’ means a provider of a service as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 of the European Parliament and of the Council ( 3 );
‘online interface’ means any software, including a website, part of a website or an application, that is operated by or on behalf of an economic operator, and which serves to give end users access to the economic operator's products;
‘corrective action’ means any action taken by an economic operator to bring any non-compliance to an end where required by a market surveillance authority or on the economic operator's own initiative;
‘voluntary measure’ means a corrective action where not required by a market surveillance authority;
‘risk’ means the combination of the probability of an occurrence of a hazard causing harm and the degree of severity of that harm;
‘product presenting a risk’ means a product having the potential to affect adversely health and safety of persons in general, health and safety in the workplace, protection of consumers, the environment, public security and other public interests, protected by the applicable Union harmonisation legislation, to a degree which goes beyond that considered reasonable and acceptable in relation to its intended purpose or under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements;
‘product presenting a serious risk’ means a product presenting a risk, for which, based on a risk assessment and taking into account the normal and foreseeable use of the product, the combination of the probability of occurrence of a hazard causing harm and the degree of severity of the harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the risk are not immediate;
‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities;
‘recall’ means any measure aimed at achieving the return of a product that has already been made available to the end user;
‘withdrawal’ means any measure aimed at preventing a product in the supply chain from being made available on the market;
‘customs authorities’ means customs authorities as defined in point 1 of Article 5 of Regulation (EU) No 952/2013;
‘release for free circulation’ means the procedure laid down in Article 201 of Regulation (EU) No 952/2013;
‘products entering the Union market’ means products from third countries intended to be placed on the Union market or intended for private use or consumption within the customs territory of the Union and placed under the customs procedure ‘release for free circulation’.
CHAPTER II
TASKS OF ECONOMIC OPERATORS
Article 4
Tasks of economic operators regarding products subject to certain Union harmonisation legislation
For the purposes of this Article, the economic operator referred to in paragraph 1 means any of the following:
a manufacturer established in the Union;
an importer, where the manufacturer is not established in the Union;
an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer's behalf;
a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.
Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:
if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request;
further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority;
when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof;
cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.
Article 5
Authorised representative
Article 6
Distance sales
Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale shall be considered to be targeted at end users in the Union if the relevant economic operator directs, by any means, its activities to a Member State.
Article 7
Obligation of cooperation
CHAPTER III
ASSISTANCE TO AND COOPERATION WITH ECONOMIC OPERATORS
Article 8
Information to economic operators
Article 9
Joint activities to promote compliance
CHAPTER IV
ORGANISATION, ACTIVITIES AND OBLIGATIONS OF MARKET SURVEILLANCE AUTHORITIES AND THE SINGLE LIAISON OFFICE
Article 10
Designation of market surveillance authorities and the single liaison office
Article 11
Activities of market surveillance authorities
Market surveillance authorities shall conduct their activities in order to ensure the following:
effective market surveillance within their territory of products made available online and offline with respect to products that are subject to Union harmonisation legislation;
the taking by economic operators of appropriate and proportionate corrective action in relation to compliance with that legislation and this Regulation;
the taking of appropriate and proportionate measures where the economic operator fails to take corrective action.
In deciding on which checks to perform, on which types of products and on what scale, market surveillance authorities shall follow a risk-based approach taking into account the following factors:
possible hazards and non-compliance associated with the products and, where available, their occurrence on the market;
activities and operations under the control of the economic operator;
the economic operator's past record of non-compliance;
if relevant, the risk profiling performed by the authorities designated under Article 25(1);
consumer complaints and other information received from other authorities, economic operators, media and other sources that might indicate non-compliance.
Market surveillance authorities shall establish the following procedures in connection with products subject to the Union harmonisation legislation:
procedures for following up on complaints or reports on issues relating to risks or non-compliance;
procedures for verifying that the corrective action that was to be taken by economic operators has been taken.
Article 12
Peer reviews
Article 13
National market surveillance strategies
The national market surveillance strategy shall include at least the following elements, when this does not compromise market surveillance activities:
the available information on the occurrence of non-compliant products, in particular taking into account the checks and controls referred to in Articles 11(3) and 25(3), respectively, and, where applicable, market trends that may affect non-compliance rates for the categories of products, and possible threats and risks related to emerging technologies;
the areas identified by the Member States as priorities for the enforcement of Union harmonisation legislation;
the enforcement activities planned in order to reduce non-compliance in those areas identified as priorities, including, where relevant, the minimum control levels envisaged for categories of products which have significant levels of non-compliance;
an assessment of the cooperation with market surveillance authorities in other Member States, as referred to in Article 11(8) and Chapter VI.
CHAPTER V
MARKET SURVEILLANCE POWERS AND MEASURES
Article 14
Powers of market surveillance authorities
When conferring powers under paragraph 1, Member States may provide for the power to be exercisable in one of the following ways, as appropriate:
directly by the market surveillance authorities under their own authority;
by recourse to other public authorities in accordance with the division of powers and the institutional and administrative organisation of the Member State in question;
upon application to courts competent to grant the necessary decision to approve the exercise of that power, including, where appropriate, on appeal, if the application to grant the necessary decision was not successful.
The powers conferred on market surveillance authorities under paragraph 1 shall include at least the following:
the power to require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product's compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof;
the power to require economic operators to provide relevant information on the supply chain, on the details of the distribution network, on quantities of products on the market and on other product models that have the same technical characteristics as the product in question, where relevant for compliance with the applicable requirements under Union harmonisation legislation;
the power to require economic operators to provide relevant information required for the purpose of ascertaining the ownership of websites, where the information in question is related to the subject matter of the investigation;
the power to carry out unannounced on-site inspections and physical checks of products;
the power to enter any premises, land or means of transport that the economic operator in question uses for purposes related to the economic operator's trade, business, craft or profession, in order to identify non-compliance and to obtain evidence;
the power to start investigations on market surveillance authorities' own initiative in order to identify non-compliances and bring them to an end;
the power to require economic operators to take appropriate action to bring an instance of non-compliance to an end or to eliminate the risk;
the power to take appropriate measures where an economic operator fails to take appropriate corrective action or where the non-compliance or the risk persists, including the power to prohibit or restrict the making available of a product on the market or to order that the product is withdrawn or recalled;
the power to impose penalties in accordance with Article 41;
the power to acquire product samples, including under a cover identity, to inspect those samples and to reverse-engineer them in order to identify non-compliance and to obtain evidence;
the power, where no other effective means are available to eliminate a serious risk:
to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface; or
where a request according to point (i) has not been complied with, to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures.
Article 15
Recovery of costs by market surveillance authorities
Article 16
Market surveillance measures
Market surveillance authorities shall take appropriate measures if a product subject to Union harmonisation legislation, when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained:
is liable to compromise the health or safety of users; or
does not conform to applicable Union harmonisation legislation.
For the purposes of paragraph 2, the corrective action required to be taken by the economic operator may include, inter alia:
bringing the product into compliance, including by rectifying formal non-compliance as defined by the applicable Union harmonisation legislation, or by ensuring that the product no longer presents a risk;
preventing the product from being made available on the market;
withdrawing or recalling the product immediately and alerting the public to the risk presented;
destroying the product or otherwise rendering it inoperable;
affixing to the product suitable, clearly worded, easily comprehensible warnings of the risks that it might present, in the language or languages determined by the Member State in which the product is made available on the market;
setting prior conditions for making the product concerned available on the market;
alerting the end users at risk immediately and in an appropriate form, including by publication of special warnings in the language or languages determined by the Member State in which the product is made available on the market.
Article 17
Use of information, professional and commercial secrecy
Market surveillance authorities shall perform their activities with a high level of transparency and shall make available to the public any information that they consider to be relevant in order to protect the interests of end users. Market surveillance authorities shall respect the principles of confidentiality and of professional and commercial secrecy and shall protect personal data in accordance with Union and national law.
Article 18
Procedural rights of economic operators
If the measure, decision or order is taken or made without the economic operator being given the opportunity to be heard, the economic operator shall be given that opportunity as soon as possible thereafter and that measure, decision or order shall be reviewed promptly by the market surveillance authority.
Article 19
Products presenting a serious risk
Article 20
Rapid Information Exchange System
Article 21
Union testing facilities
The Commission may also designate one of its own testing facilities as a Union testing facility for specific categories of products or for specific risks related to a category of products, or for products for which testing capacity is missing or is not sufficient.
Union testing facilities shall, within the area of their competence, perform the following activities:
carry out testing of products at the request of market surveillance authorities, the Network or the Commission;
provide independent technical or scientific advice at the request of the Network;
develop new techniques and methods of analysis.
CHAPTER VI
CROSS-BORDER MUTUAL ASSISTANCE
Article 22
Mutual Assistance
In duly justified cases, a requested authority may refuse to comply with a request for information under paragraph 2 where:
the applicant authority has not sufficiently substantiated that the requested information is necessary in order to establish non-compliance;
the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.
Article 23
Requests for enforcement measures
A requested authority may refuse to comply with a request for enforcement measures in any of the following situations:
the requested authority concludes that the applicant authority has not provided sufficient information;
the requested authority considers that the request is contrary to Union harmonisation legislation;
the requested authority demonstrates reasonable grounds showing that complying with the request would substantially impair the execution of its own activities.
Article 24
Procedure for mutual assistance requests
CHAPTER VII
PRODUCTS ENTERING THE UNION MARKET
Article 25
Controls on products entering the Union market
Each Member State shall inform the Commission and the other Member States of the authorities designated under the first subparagraph and of their areas of competence through the information and communication system referred to in Article 34.
Risk-related information shall be exchanged between:
the authorities designated under paragraph 1 of this Article in accordance with Article 47(2) of Regulation (EU) No 952/2013; and
customs authorities in accordance with Article 46(5) of Regulation (EU) No 952/2013.
Where, in relation to products subject to Union law that are either in temporary storage or placed under a customs procedure other than ‘release for free circulation’, customs authorities at the first point of entry have reason to believe that those products are not compliant with applicable Union law or present a risk, they shall transmit all relevant information to the competent customs office of destination.
The Commission shall draw up a report by 30 June of each year, containing the information provided by the Member States for the previous calendar year and an analysis of the data submitted. The report shall be published in the information and communication system referred to in Article 34.
Article 26
Suspension of release for free circulation
Authorities designated under Article 25(1) shall suspend the release of a product for free circulation if in the course of controls pursuant to Article 25(3), it is established that:
the product is not accompanied by the documentation required by the Union law applicable to it or there is a reasonable doubt as to the authenticity, accuracy or completeness of such documentation;
the product is not marked or labelled in accordance with the Union law applicable to it;
the product bears a CE marking or other marking required by the Union law applicable to it which has been affixed in a false or misleading manner;
the name, registered trade name or registered trade mark and the contact details, including the postal address, of an economic operator with tasks regarding the product subject to certain Union harmonisation legislation is not indicated or identifiable in accordance with Article 4(4); or
for any other reason, when there is cause to believe that the product does not comply with the Union law applicable to it or that it presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1.
Article 27
Release for free circulation
Where the release of a product for free circulation has been suspended in accordance with Article 26, that product shall be released for free circulation where all the other requirements and formalities relating to such a release have been fulfilled and where either of the following conditions is satisfied:
within four working days of the suspension, the authorities designated under Article 25(1) have not been requested by the market surveillance authorities to maintain the suspension;
the authorities designated under Article 25(1) have been informed by the market surveillance authorities of its approval for release for free circulation.
The release for free circulation shall not be deemed to be proof of conformity with Union law.
Article 28
Refusal to release for free circulation
Where the market surveillance authorities conclude that a product presents a serious risk, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require these authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document:
‘Dangerous product — release for free circulation not authorised — Regulation (EU) 2019/1020’.
Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.
Where market surveillance authorities conclude that a product may not be placed on the market since it does not comply with the Union law applicable to it, they shall take measures to prohibit the placing of the product on the market and shall require the authorities designated under Article 25(1) not to release it for free circulation. They shall also require those authorities to include the following notice in the customs data-processing system, and, where appropriate, on the commercial invoice accompanying the product and on any other relevant accompanying document:
‘Product not in conformity — release for free circulation not authorised — Regulation (EU) 2019/1020’.
Market surveillance authorities shall immediately enter that information in the information and communication system referred to in Article 34.
Articles 197 and 198 of Regulation (EU) No 952/2013 shall apply accordingly.
CHAPTER VIII
COORDINATED ENFORCEMENT AND INTERNATIONAL COOPERATION
Article 29
Union Product Compliance Network
Article 30
Composition and functioning of the Network
ADCOs meetings are intended only for representatives of market surveillance authorities and the Commission.
Relevant stakeholders, such as organisations representing the interests of industry, small and medium-sized enterprises (SMEs), consumers, testing laboratories, standardisation and conformity assessment bodies at Union level, may be invited to attend the ADCOs meetings depending on the subject matter of discussion.
Article 31
Role and tasks of the Network
The Network shall have the following tasks:
to prepare, adopt and monitor the implementation of its work programme;
to facilitate the identification of common priorities for market surveillance activities and the exchange of information across sectors on evaluations of products, including risk assessment, test methods and results, recent scientific developments and new technologies, emerging risks and other aspects relevant to control activities and on the implementation of national market surveillance strategies and activities;
to coordinate ADCOs and their activities;
to organise cross-sector joint market surveillance and testing projects and define their priorities;
to exchange expertise and best practices, in particular regarding the implementation of national market surveillance strategies;
to facilitate the organisation of training programmes and exchanges of personnel;
in collaboration with the Commission, to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities;
to discuss questions arising from cross-border mutual assistance mechanisms;
to contribute to the development of guidance to ensure the effective and uniform application of this Regulation;
to propose the financing of activities referred to in Article 36;
to contribute to uniform administrative practices with regard to market surveillance in the Member States;
to provide advice and assist the Commission with issues related to the further development of RAPEX and the information and communication system referred to in Article 34;
to promote the cooperation and exchange of expertise and best practices between market surveillance authorities and authorities in charge of controls at the Union's external borders;
to promote and facilitate collaboration with other relevant networks and groups, with a view to explore possibilities for using new technologies for the purposes of market surveillance and traceability of products;
to evaluate regularly the national market surveillance strategies, the first such evaluation taking place by 16 July 2024;
to take up any other issues in activities within the remit of the Network, with the aim of contributing to the effective functioning of market surveillance within the Union.
Article 32
Role and tasks of administrative cooperation groups
ADCOs shall have the following tasks:
to facilitate the uniform application of Union harmonisation legislation within their area of competence with a view to increasing the efficiency of market surveillance throughout the internal market;
to promote communication between market surveillance authorities and the Network and develop mutual confidence between market surveillance authorities;
to establish and coordinate common projects, such as cross-border joint market surveillance activities;
to develop common practices and methodologies for effective market surveillance;
to inform each other of national market surveillance methods and activities and to develop and promote best practices;
to identify issues of shared interest relating to market surveillance and suggest common approaches to be adopted;
to facilitate sector-specific evaluations of products, including risk assessments, test methods and results, recent scientific developments and other aspects relevant to control activities.
Article 33
Role and tasks of the Commission
The Commission shall have the following tasks:
to assist the Network, its sub-groups, and the ADCOs by means of an executive secretariat that provides technical and logistic support;
to keep and make available to the single liaison offices and ADCO chairs an updated list of ADCO chairs, including their contact information;
to assist the Network in preparing and monitoring its work programme;
to support the functioning of the Product Contact Points having duties assigned by Member States in relation to Union harmonisation legislation;
to determine, in consultation with the Network, the need for additional testing capacity and to propose solutions for that purpose, in accordance with Article 21;
to apply the instruments of international cooperation referred to in Article 35;
to provide support for the establishment of separate or joint ADCOs;
to develop and maintain the information and communication system referred to in Article 34, including the interface referred to in Article 34(7), as well as the interface with national market surveillance databases, and provide information to the public by means of that system;
to assist the Network to perform preliminary or ancillary work in connection with the implementation of market surveillance activities linked to the application of Union harmonisation legislation, such as studies, programmes, evaluations, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
to prepare and assist in the implementation of Union market surveillance campaigns and similar activities;
to organise joint market surveillance and testing projects, and common training programmes, to facilitate exchanges of personnel between market surveillance authorities and, where appropriate, with the market surveillance authorities of third countries or with international organisations, and to organise information campaigns and voluntary mutual visit programmes between market surveillance authorities;
to carry out activities under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems among interested parties at Union and international level;
to facilitate technical or scientific expertise for the purpose of implementing market surveillance administrative cooperation;
to examine, at the request of the Network or on its own initiative, any question covering the application of this Regulation and issue guidelines, recommendations and best practices in order to encourage consistent application of this Regulation.
Article 34
Information and communication system
Single liaison offices shall enter the following information in the information and communication system:
the identity of the market surveillance authorities in their Member State and areas of competence of those authorities pursuant to Article 10(2);
the identity of the authorities designated under Article 25(1);
the national market surveillance strategy drawn up by their Member State under Article 13 and the results from the review and assessment of the market surveillance strategy.
Market surveillance authorities shall enter into the information and communication system in relation to products made available on the market for which an in-depth check of compliance has been carried out, without prejudice to Article 12 of Directive 2001/95/EC and Article 20 of this Regulation, and where applicable, in relation to products entering the Union market for which the process for the release for free circulation has been suspended in accordance with Article 26 of this Regulation, in their territory, the following information concerning:
measures according to Article 16(5) taken by that market surveillance authority;
reports of testing carried out by them;
corrective action taken by economic operators concerned;
readily available reports on injuries caused by the product in question;
any objection raised by a Member State in accordance with the applicable safeguard procedure in the Union harmonisation legislation applicable to the product and any subsequent follow-up;
where available, failures by authorised representatives to comply with Article 5(2);
where available, failures by manufacturers to comply with Article 5(1).
Article 35
International cooperation
The cooperation or exchange of information may relate, inter alia, to the following:
risk assessment methods used and the results of product-testing;
coordinated product recalls or other similar actions;
the measures taken by market surveillance authorities under Article 16.
Approval may only be granted to a third country under paragraph 3 if following conditions are satisfied:
the third country possesses an efficient verification system of the compliance of products exported to the Union, and the controls carried out in that third country are sufficiently effective and efficient to replace or reduce import controls;
audits within the Union and, if relevant, in the third country demonstrate that products exported from that third country to the Union satisfy the requirements set out in Union harmonisation legislation.
Authorities designated under Article 25(1) may however carry out controls on those products or categories of products entering the Union market, including in order to ensure that the pre-export controls carried out by the third country are effective to determine compliance with Union harmonisation legislation.
CHAPTER IX
FINANCIAL PROVISIONS
Article 36
Financing activities
The Union may finance the following activities in relation to the application of this Regulation:
the functioning of the Product Contact Points;
the establishment and functioning of Union testing facilities referred to in Article 21;
the development of instruments of international cooperation referred to in Article 35;
the drawing up and updating of contributions to guidelines on market surveillance;
the making available to the Commission of technical or scientific expertise for the purpose of assisting the Commission in its implementation of market surveillance administrative cooperation;
the implementation of national market surveillance strategies referred to in Article 13;
Member States' and Union market surveillance campaigns and associated activities, including resources and equipment, IT tools and training;
the performance of preliminary or ancillary work in connection with market surveillance activities related to the application of Union harmonisation legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits and visit programmes, exchange of personnel, research work, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
activities carried out under programmes providing technical assistance, cooperation with third countries and the promotion and enhancement of Union market surveillance policies and systems amongst interested parties at Union and international level.
Article 37
Protection of the financial interests of the Union
CHAPTER X
AMENDMENTS
Article 38
Amendments to Directive 2004/42/EC
Articles 6 and 7 of Directive 2004/42/EC of the European Parliament and of the Council ( 26 ) are deleted.
Article 39
Amendments to Regulation (EC) No 765/2008
Regulation (EC) No 765/2008 is amended as follows:
the title is replaced by the following:
‘Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93’;
in Article 1, paragraphs 2 and 3 are deleted;
in Article 2, points 1, 2, 14, 15, 17, 18 and 19 are deleted;
Chapter III, containing Articles 15 to 29, is deleted;
paragraph 1 of Article 32 is amended as follows:
point (c) is replaced by the following:
‘(c) the drawing up and updating of contributions to guidelines in the fields of accreditation, notification to the Commission of conformity assessment bodies and conformity assessment;’;
points (d) and (e) are deleted;
points (f) and (g) are replaced by the following:
the performance of preliminary or ancillary work in connection with the implementation of the conformity assessment, metrology and accreditation activities linked to the implementation of Community legislation, such as studies, programmes, evaluations, guidelines, comparative analyses, mutual joint visits, research work, the development and maintenance of databases, training activities, laboratory work, proficiency testing, inter-laboratory tests and conformity assessment work;
activities carried out under programmes of technical assistance, cooperation with third countries and the promotion and enhancement of European conformity assessment and accreditation policies and systems among interested parties in the Community and at international level.’
Article 40
Amendments to Regulation (EU) No 305/2011
In Article 56(1) of Regulation (EU) No 305/2011, the first subparagraph is replaced by the following:
CHAPTER XI
FINAL PROVISIONS
Article 41
Penalties
Article 42
Evaluation, review and guidelines
Article 43
Committee procedure
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 11(4), Article 21(9), Article 25(8), Article 35(10) and Article 35(11) of this Regulation, and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 44
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 16 July 2021. However, Articles 29, 30, 31, 32, 33 and 36 shall apply from 1 January 2021.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
List of Union harmonisation legislation
Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36);
Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);
Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14);
Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40);
Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1);
Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40);
Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17);
Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);
European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10);
Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58);
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1);
Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1);
Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (OJ L 269, 21.10.2000, p. 34);
Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1);
Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1);
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7);
Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87);
Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10);
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24);
Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12);
Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1) ;
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1);
Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1);
Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17);
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1);
Regulation (EC) No 78/2009 of the European Parliament and of the Council of 14 January 2009 on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC (OJ L 35, 4.2.2009, p. 1);
Regulation (EC) No 79/2009 of the European Parliament and of the Council of 14 January 2009 on type-approval of hydrogen-powered motor vehicles, and amending Directive 2007/46/EC (OJ L 35, 4.2.2009, p. 32);
Directive 2009/34/EC of the European Parliament and of the Council of 23 April 2009 relating to common provisions for both measuring instruments and methods of metrological control (OJ L 106, 28.4.2009, p. 7);
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1);
Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1);
Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1);
Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10);
Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 31.10.2009, p. 1);
Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46);
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59);
Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel (OJ L 27, 30.1.2010, p. 1);
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1);
Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5);
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88);
Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 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 of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1);
Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1);
Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE) (OJ L 197, 24.7.2012, p. 38);
Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1);
Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013, p. 52);
Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27);
Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90);
Directive 2014/28/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 the making available on the market and supervision of explosives for civil uses (OJ L 96, 29.3.2014, p. 1);
Directive 2014/29/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 the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45);
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 (OJ L 96, 29.3.2014, p. 79);
Directive 2014/31/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 the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107);
Directive 2014/32/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 the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149);
Directive 2014/33/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 lifts and safety components for lifts (OJ L 96, 29.3.2014, p. 251);
Directive 2014/34/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 equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309);
Directive 2014/35/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 the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357);
Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1);
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 (OJ L 153, 22.5.2014, p. 62);
Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164);
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);
Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (OJ L 150, 20.5.2014, p. 195);
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 (OJ L 158, 27.5.2014, p. 131);
Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC (OJ L 81, 31.3.2016, p. 1);
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51);
Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99);
Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53);
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 (OJ L 117, 5.5.2017, p. 1);
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 (OJ L 117, 5.5.2017, p. 176);
Regulation (EU) 2017/852 of the European Parliament and of the Council of 17 May 2017 on mercury, and repealing Regulation (EC) No 1102/2008 (OJ L 137, 24.5.2017, p. 1);
Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1);
Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1);
Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1), in so far as the design, production and placing on the market of aircrafts referred to in points (a) and (b) of Article 2(1) thereof, where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely, are concerned.
ANNEX II
List of Union harmonisation legislation without provisions on penalties
Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36);
Council Directive 70/157/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the permissible sound level and the exhaust system of motor vehicles (OJ L 42, 23.2.1970, p. 16);
Council Directive 75/107/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to bottles used as measuring containers (OJ L 42, 15.2.1975, p. 14);
Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (OJ L 147, 9.6.1975, p. 40);
Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain pre-packaged products (OJ L 46, 21.2.1976, p. 1);
Council Directive 92/42/EEC of 21 May 1992 on efficiency requirements for new hot-water boilers fired with liquid or gaseous fuels (OJ L 167, 22.6.1992, p. 17);
Directive 94/11/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws, regulations and administrative provisions of the Member States relating to labelling of the materials used in the main components of footwear for sale to the consumer (OJ L 100, 19.4.1994, p. 37);
European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10);
Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1);
Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles (OJ L 269, 21.10.2000, p. 34);
Directive 2005/64/EC of the European Parliament and of the Council of 26 October 2005 on the type-approval of motor vehicles with regard to their reusability, recyclability and recoverability and amending Council Directive 70/156/EEC (OJ L 310, 25.11.2005, p. 10);
Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12);
Directive 2007/45/EC of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for pre-packed products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC (OJ L 247, 21.9.2007, p. 17);
Regulation (EC) No 1222/2009 of the European Parliament and of the Council of 25 November 2009 on the labelling of tyres with respect to fuel efficiency and other essential parameters (OJ L 342, 22.12.2009, p. 46);
Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment and repealing Council Directives 76/767/EEC, 84/525/EEC, 84/526/EEC, 84/527/EEC and 1999/36/EC (OJ L 165, 30.6.2010, p. 1);
Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5);
Regulation (EU) No 1007/2011 of the European Parliament and of the Council of 27 September 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 of the European Parliament and of the Council (OJ L 272, 18.10.2011, p. 1);
Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146);
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 (OJ L 158, 27.5.2014, p. 131).
ANNEX III
Correlation table
|
Regulation (EC) No 765/2008 |
This Regulation |
|
Article 1(2) |
Article 1(1) |
|
Article 1(3) |
Article 1(3) |
|
Article 2, point 1 |
Article 3, point 1 |
|
Article 2, point 2 |
Article 3, point 2 |
|
Article 2, point 14 |
Article 3, point 22 |
|
Article 2, point 15 |
Article 3, point 23 |
|
Article 2, point 17 |
Article 3, point 3 |
|
Article 2, point 18 |
Article 3, point 4 |
|
Article 2, point 19 |
Article 3, point 25 |
|
Article 15(1) and (2) |
Article 2(1) |
|
Article 15(3) |
Article 2(3) |
|
Article 15(4) |
— |
|
Article 15(5) |
Article 2(2) |
|
Article 16(1) |
Article 10(1) |
|
Article 16(2) |
Article 16(5) |
|
Article 16(3) |
— |
|
Article 16(4) |
— |
|
Article 17(1) |
Article 10(2) |
|
Article 17(2) |
Article 34(1), last sentence and Article 34(3), point (a) |
|
Article 18(1) |
Article 10(6) |
|
Article 18(2), point (a) |
Article 11(7), point (a) |
|
Article 18(2), point (b) |
— |
|
Article 18(2), point (c) |
Article 11(7), point (b) |
|
Article 18(2), point (d) |
— |
|
Article 18(3) |
Articles 10(5) and 14(1) |
|
Article 18(4) |
Article 14(2) |
|
Article 18(5) |
Article 13 |
|
Article 18(6) |
Article 31(2), point (o) |
|
Article 19(1), first subparagraph |
Article 11(3) |
|
Article 19(1), second subparagraph |
Article 14(4), points (a), (b), (e) and (j) |
|
Article 19(1), third subparagraph |
Article 11(5) |
|
Article 19(2) |
Article 16(3), point (g) |
|
Article 19(3) |
Article 18(2) |
|
Article 19(4) |
Article 11(2) |
|
Article 19(5) |
Article 17 |
|
Article 20(1) |
Article 19(1) |
|
Article 20(2) |
Article 19(2) |
|
Article 21(1) |
Article 18(1) |
|
Article 21(2) |
Article 18(2) |
|
Article 21(3) |
Article 18(3) |
|
Article 21(4) |
— |
|
Article 22(1) |
Article 20(1) |
|
Article 22(2) |
Article 20(2) |
|
Article 22(3) |
Article 20(3) |
|
Article 22(4) |
Article 20(4) |
|
Article 23(1) and (3) |
Article 34(1) |
|
Article 23(2) |
Article 34(4) |
|
Article 24(1) |
Article 22(1) |
|
Article 24(2) |
Article 22(2) to (5) |
|
Article 24(3) |
— |
|
Article 24(4) |
— |
|
Article 25(1) |
— |
|
Article 25(2), point (a) |
Article 31(2), point (f) and Article 33(1), points (i) and (k) |
|
Article 25(2), point (b) |
Article 31(2), points (g) and (m) and Article 33(1), points (i) and (k) |
|
Article 25(3) |
— |
|
Article 26 |
— |
|
Article 27(1), first sentence |
Article 25(2) |
|
Article 27(1), second sentence |
Article 25(3) |
|
Article 27(2) |
Article 25(4) |
|
Article 27(3), first subparagraph |
Article 26(1) |
|
Article 27(3), second subparagraph |
Article 26(2) |
|
Article 27(4) |
— |
|
Article 27(5) |
— |
|
Article 28(1) |
Article 27, first paragraph, point (a) |
|
Article 28(2) |
Article 27, first paragraph, point (b) |
|
Article 29(1) |
Article 28(1) |
|
Article 29(2) |
Article 28(2) |
|
Article 29(3) |
Article 28(3) |
|
Article 29(4) |
Article 28(4) |
|
Article 29(5) |
Article 25(5) |
|
Article 32(1), point (d) |
— |
|
Article 32(1), point (e) |
Article 36(2), point (e) |
( 1 ) Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).
( 2 ) Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).
( 3 ) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
( 4 ) Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC (OJ L 88, 4.4.2011, p. 5).
►M1 ( 5 ) Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51). ◄
►M1 ( 6 ) Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC (OJ L 81, 31.3.2016, p. 99).
( 7 ) Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC (OJ L 191, 28.7.2023, p. 1). ◄
( 8 ) Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors (OJ L 162, 3.7.2000, p. 1).
( 9 ) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).
( 10 ) Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1).
( 11 ) Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products (OJ L 285, 31.10.2009, p. 10).
( 12 ) Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011, p. 88).
( 13 ) Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (OJ L 178, 28.6.2013, p. 27).
( 14 ) Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC (OJ L 354, 28.12.2013, p. 90).
( 15 ) Directive 2014/29/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 the making available on the market of simple pressure vessels (OJ L 96, 29.3.2014, p. 45).
( 16 ) 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 (OJ L 96, 29.3.2014, p. 79).
( 17 ) Directive 2014/31/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 the making available on the market of non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
( 18 ) Directive 2014/32/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 the making available on the market of measuring instruments (OJ L 96, 29.3.2014, p. 149).
( 19 ) Directive 2014/34/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 equipment and protective systems intended for use in potentially explosive atmospheres (OJ L 96, 29.3.2014, p. 309).
( 20 ) Directive 2014/35/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 the making available on the market of electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 357).
( 21 ) 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 (OJ L 153, 22.5.2014, p. 62).
( 22 ) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (OJ L 189, 27.6.2014, p. 164).
( 23 ) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
( 24 ) Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18.9.2013, p. 1).
( 25 ) Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15.11.1996, p. 2).
( 26 ) Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (OJ L 143, 30.4.2004, p. 87).