COMMISSION NOTICE

The ‘Blue Guide’ on the implementation of EU product rules 2022

(Text with EEA relevance)

(2022/C 247/01)

TABLE OF CONTENTS

1. REGULATING THE FREE MOVEMENT OF GOODS 5

1.1. A historical perspective 5

1.1.1. The ‘Old Approach’ 6

1.1.2. Mutual Recognition and Regulation (EU) 2019/515 on the Mutual Recognition of Goods 6

1.1.3. The ‘New Approach’ and the ‘Global Approach’ 7

1.2. The ‘New Legislative Framework’ 9

1.2.1. The modernisation of market surveillance provisions 10

1.2.2. The legal nature of the NLF acts and the Market Surveillance legislation and their relationship to other EU legislation 11

1.2.3. How the system fits together 12

1.3. The General Product Safety Directive 12

1.4. The legislation on product liability 13

1.5. Scope of the Guide 13

2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY? 15

2.1. Product coverage 15

2.2. Making available on the market 19

2.3. Placing on the market 19

2.4. Making available and placing on the market in case of distance and online sales 21

2.5. Products imported from countries outside the EU 22

2.6. Putting into service or use (and installation) 23

2.7. Simultaneous application of Union harmonisation acts 24

2.8. Reasonably foreseeable and Intended use / misuse 25

2.9. Geographical application (EEA EFTA states, Overseas Countries and Territories (OCTs), Turkey) 26

2.9.1. Member States and Overseas countries and territories 26

2.9.2. EEA EFTA states 27

2.9.3. Monaco, San Marino and Andorra 27

2.9.4. Turkey 28

2.9.5. Withdrawal of the United Kingdom from the EU 29

2.9.6. Northern Ireland 30

2.10. Transitional periods in the case of new or revised EU rules 31

2.11. Transitional arrangements for the EU Declaration of Conformity 32

2.12. Summary examples 33

3. THE ACTORS IN THE PRODUCT SUPPLY CHAIN AND THEIR OBLIGATIONS 34

3.1. Manufacturer 34

3.2. Authorised representative 38

3.3. Importer 39

3.4. Distributor 41

3.5. Fulfilment Service Providers 43

3.6. The economic operator Referred to in Article 4 of Regulation (EU) 2019/1020 43

3.7. Other intermediaries: Intermediary service providers under the E-commerce Directive 45

3.8. End-user 46

4. PRODUCT REQUIREMENTS 47

4.1. Essential product requirements 47

4.1.1. Definition of essential requirements 47

4.1.2. Conformity with the essential requirements: harmonised standards 49

4.1.3. Conformity with the essential requirements: other possibilities 55

4.2. Traceability requirements 56

4.2.1. Why does Traceability matter? 56

4.2.2. Traceability provisions 56

4.3. Technical documentation 61

4.4. EU declaration of conformity 62

4.5. Marking requirements 64

4.5.1. CE marking 64

4.5.2. Other mandatory markings 69

5. CONFORMITY ASSESSMENT 70

5.1. Modules for conformity assessment 70

5.1.1. What is a conformity assessment? 70

5.1.2. The modular structure of conformity assessment in Union harmonisation legIslation 70

5.1.3. Actors in conformity assessment – Positioning of conformity assessment in the supply chain 71

5.1.4. Modules and their variants 74

5.1.5. One- and two-module procedures – Procedures based on type (EU-type examination) 74

5.1.6. Modules based on quality assurance 75

5.1.7. Overview of modules 76

5.1.8. Overview of procedures 78

5.1.9. Rationale for selecting the appropriate modules 80

5.2. Conformity assessment bodies 81

5.2.1. Conformity assessment bodies and notified bodies 81

5.2.2. Roles and responsibilities 81

5.2.3. Competence of Notified bodies 84

5.2.4. Coordination between notified bodies 84

5.2.5. Subcontracting by notified bodies 85

5.2.6. Accredited in-house bodies 87

5.3. Notification 87

5.3.1. Notifying authorities 87

5.3.2. Notification process 88

5.3.3. Publication by the commission – the NANDO web site 92

5.3.4. Monitoring of the competence of notified bodies - Suspension – withdrawal - appeal 93

6. ACCREDITATION 94

6.1. Why accreditation? 94

6.2. What is accreditation? 95

6.3. Scope of Accreditation 96

6.4. Accreditation according to Regulation (EC) No 765/2008 96

6.4.1. National accreditation bodies 96

6.4.2. Non-competition and non-commerciality of national accreditation bodies 98

6.5. The European accreditation infrastructure 99

6.5.1. Sectoral accreditation schemes 99

6.5.2. Peer evaluation 99

6.5.3. Presumption of conformity for national accreditation bodies 100

6.5.4. EA’s role in supporting and harmonising accreditation practice across europe 100

6.6. Cross-border accreditation 100

6.7. Accreditation in the international context 102

6.7.1. Cooperation between accreditation bodies 102

6.7.2. The impact on trade relations in the field of conformity assessment between the EU and Third Countries 103

7. MARKET SURVEILLANCE 104

7.1. Why do we need market surveillance? 104

7.2. Scope of Regulation (EU) 2019/1020 105

7.3. Organisation of Market Surveillance 106

7.3.1. National infrastructures 107

7.3.2. National market surveillance strategies 107

7.3.3. Public information 108

7.3.4. Sanctions 108

7.4. Checks by Market Surveillance authorities 109

7.4.1. Market surveillance activities 109

7.4.2. Market surveillance Measures 111

7.5. Control on products from third countries 113

7.5.1. Role of border authorities 114

7.5.2. Principles of border controls 114

7.5.3. Applicable procedures 114

7.6. Cooperation Among Member States and with the European commission 116

7.6.1. EU-wide action on non-compliance 116

7.6.2. The application of the safeguard clause 117

7.6.3. Mutual assistance, Administrative Cooperation and the EU product compliance network 120

7.6.4. Rapid Alert SYstem for non-food products presenting a risk (RAPEX) 122

7.6.5. ICSMS 123

7.6.6. Medical devices: vigilance system 125

8. FREE MOVEMENT OF PRODUCTS WITHIN THE EU 126

8.1. Free movement clause 126

8.2. Limits and restrictions 126

9. INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS 127

9.1. Agreements on Conformity Assessment and Acceptance of industrial products (ACAAs) 127

9.2. Mutual recognition agreements (MRAs) 128

9.2.1. Main characteristics 128

9.2.2. EU-Swiss MRA 129

9.2.3. EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance 130

9.2.4. CETA Protocol on conformity assessment 130

9.3. The Trade and Cooperation agreement with the UK 131

ANNEXES 132

Annex 1 – EU legislation referred to in the Guide (non-exhaustive list) 132

Annex 2 – Additional guidance documents 136

Annex 3 – Useful web addresses 138

Annex 4 – Conformity assessment procedures (modules from Decision No 768/2008/EC) 139

Annex 5 – Frequently Asked Questions on CE marking 150

PREFACE

The Guide to the implementation of directives based on the New Approach and the Global Approach (the ‘Blue Guide’) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework (NLF). The Guide has the ambition of explaining the different elements of the NLF as well as of market surveillance.

The ‘Blue Guide’ was revised in 2014 to cover new developments and to ensure the broadest possible common understanding on implementation of the NLF for the marketing of products. It was further revised and adapted in 2016.

This new version of the Guide builds on the past editions, but also reflects recent changes in the legislation and in particular the adoption of a new Regulation on Market Surveillance (1).

IMPORTANT NOTICE

This Guide is intended to contribute to a better understanding of EU product rules and to their more uniform and coherent application across different sectors and throughout the single market. It is addressed to the Member States and others who need to be informed of the provisions designed to ensure the free circulation of products as well as a high level of protection throughout the Union (e.g. trade and consumer associations, standardisation bodies, manufacturers, importers, distributors, conformity assessment bodies and trade unions). It is built on consultation among all the interested parties.

This is intended purely as a guidance document – only the text of the Union harmonisation act itself has legal force. In certain cases, there may be differences between the provisions of a Union harmonisation act and the contents of this Guide, in particular where slightly divergent provisions in the individual Union harmonisation act cannot be fully described in this Guide. The binding interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union. The views expressed in this Guide cannot prejudge the position that the Commission might take before the Court of Justice. Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information.

This Guide applies to the EU Member States but also to Iceland, Liechtenstein and Norway as signatories of the Agreement on the European Economic Area (EEA), as well as Switzerland and Turkey in certain cases. References to the Union or the single market are, accordingly, to be understood as referring to the EEA, or to the EEA market.

As this Guide reflects the legislation at the time of its drafting, the guidance offered may be subject to later modification.

1. REGULATING THE FREE MOVEMENT OF GOODS

1.1. A historical perspective

The objectives of the first harmonisation directives focused on the elimination of barriers and on the free movement of goods in the single market. These objectives are now being complemented by a comprehensive policy geared to ensuring that only safe and otherwise compliant products find their way on to the market, in such a way that honest economic operators can benefit from a level playing field, thus promoting at the same time an effective protection of EU consumers and professional users and a competitive single EU market.

Policies and legislative techniques have evolved over the last 40 years of European integration, especially in the area of the free movement of goods, thereby contributing to the success of the Single Market today.

Historically, EU legislation for goods has progressed through five main phases:

— the traditional approach or ‘Old Approach’ with detailed texts containing all the necessary technical and administrative requirements;

— the ‘New Approach’ developed in 1985, which restricted the content of legislation to ‘essential requirements’ leaving the technical details to European harmonised standards. This in turn led to the development of European standardisation policy to support this legislation;

— the development of the conformity assessment instruments made necessary by the implementation of the various Union harmonisation acts, both New Approach and Old Approach;

— the ‘New Legislative Framework’ (2) adopted in July 2008, which built on the New Approach and completed the overall legislative framework with all the necessary elements for effective conformity assessment, accreditation and market surveillance including the control of products from outside the Union;

— the adoption of a new Regulation on Market Surveillance (3) and a new Regulation on Mutual Recognition of goods lawfully marketed in another Member State (4) in 2019.

1.1.1. The ‘Old Approach’

The Old Approach reflected the traditional manner in which national authorities drew up technical legislation, going into great detail - usually motivated by a lack of confidence in the rigour of economic operators on issues of public health and safety. In certain sectors (e.g. legal metrology) this even led public authorities to deliver certificates of conformity themselves. The unanimity required in this field until 1986 made the adoption of such legislation very unwieldy and the continued recourse to this technique in a number of sectors is often justified for reasons of public policy (e.g. food legislation) or by international traditions and/or agreements which cannot be changed unilaterally (e.g. automobile legislation or food again).

The first attempt to break out of this situation came with the adoption of Directive 83/189/EEC (5) on 28 March 1983 setting up an information procedure between the Member States and the Commission to avoid the creation of new technical barriers to the free movement of goods, which would take a long time to correct through the harmonisation process.

Under that Directive, Member States are obliged to notify draft national technical regulations to other Member States and the Commission (and national standardisation bodies (NSB) were obliged to notify draft national standards (6) to the Commission, to the European standardisation organisations (ESO) and to other national standardisation bodies). During a standstill period, these technical regulations may not be adopted, leaving the Commission and the other Member States the possibility to react. In the absence of reactions within the initial standstill period of three months, the draft technical regulations may then be adopted. Otherwise, where objections are raised, a further three month standstill is imposed.

The standstill period is 12 months in the presence of a proposal for a Union harmonisation act in the area in question. However, the standstill period does not apply where a Member State is obliged to introduce technical regulations urgently to protect public health or safety, animals or plants.

1.1.2. Mutual Recognition and Regulation (EU) 2019/515 on the Mutual Recognition of Goods

Alongside legislative initiatives to prevent new barriers and promote the free movement of goods, the systematic application of the principle of mutual recognition enshrined in EU law was also pursued. National technical regulations are subject to the provisions of Articles 34 to 36 of the Treaty on the Functioning of the European Union (TFEU) (7), which prohibit quantitative restrictions or measures having equivalent effect. Case law of the Court of Justice, especially case 120/78 (the ‘Cassis de Dijon’ case (8)), provides the key elements for mutual recognition. The effect of this case law is as follows.

— Products lawfully marketed in one Member State should in principle move freely throughout the Union.

— In the absence of Union harmonisation legislation, Member States are free to legislate on their territory subject to the Treaty rules on free movement of goods (Arts. 34 – 36 TFEU).

— Barriers to free movement of goods which result from differences in national legislation may only be accepted if: 1) the national rule of the Member State of destination pursues a legitimate public interest objective, and 2) the measure restricting or denying access is proportionate, meaning that the measure is appropriate for securing the attainment of the objective and necessary (it does not go beyond what is necessary for attaining the objective).

To help implement these principles, the European Parliament and the Council adopted Regulation (EC) No 764/2008 of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision 3052/95/EC (9). This Regulation has now been replaced by Regulation (EU) 2019/515.

Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State applies as of 19 April 2020. It introduces the following points to facilitate the application of the principle of mutual recognition (10):

1. A voluntary ‘mutual recognition declaration’, which businesses can use to demonstrate that their products are lawfully marketed in another Member State;

2. A business-friendly problem solving procedure, based on SOLVIT, which helps businesses when mutual recognition is denied;

3. Stronger administrative cooperation to improve the application of the mutual recognition principle;

4. More information to businesses through ‘product contact points’ and the ‘single digital gateway’.

However, while contributing greatly to the free movement of goods within the single market, the mutual recognition principle cannot solve all the problems and there remains, even today, room for further harmonisation.

1.1.3. The ‘New Approach’ and the ‘Global Approach’

The Cassis de Dijon case is well known for its important role in promoting the mutual recognition principle but it also played an immense role in modifying the EU approach to technical harmonisation on three fundamental counts:

— in stating that Member States could only justify forbidding or restricting the marketing of products from other Member States on the basis of non-conformity with ‘essential requirements’, the Court opened a reflection on the content of future harmonisation legislation: since non-respect of non-essential requirements could not justify restricting the marketing of a product, such non-essential requirements need no longer figure in EU harmonisation texts. This opened the door to the New Approach and the consequent reflection on what constitutes an essential requirement and how to formulate it in such a manner that conformity can be demonstrated;

— in stating this principle, the Court clearly placed the onus on national authorities to demonstrate where products did not conform to essential requirements but it also begged the question of the appropriate means for demonstrating conformity in a proportionate manner;

— by noting that Member States were obliged to accept products from other Member States except in circumscribed conditions, the Court identified a legal principle but did not produce the means to create the trust in the products that could help authorities to accept products they could not vouch for. This led to the need to develop a policy on conformity assessment.

The New Approach legislative technique approved by the Council of Ministers on 7 May 1985 in its Resolution on a new approach to technical harmonisation and standards (11) was the logical legislative follow up to the Cassis de Dijon case. This regulatory technique established the following principles:

— Legislative harmonisation should be limited to the essential requirements (preferably performance or functional requirements) that products placed on the EU market must meet if they are to benefit from free movement within the EU;

— The technical specifications for products meeting the essential requirements set out in legislation should be laid down in harmonised standards which can be applied alongside the legislation;

— Products manufactured in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirements of the applicable legislation, and, in some cases, the manufacturer may benefit from a simplified conformity assessment procedure (in many instances the manufacturer’s Declaration of Conformity, made more easily acceptable to public authorities by the existence of the product liability legislation).

— The application of harmonised or other standards remains voluntary, and the manufacturer can always apply other technical specifications to meet the requirements (but will carry the burden of demonstrating that these technical specifications answer the needs of the essential requirements, more often than not, through a process involving a third party conformity assessment body).

The operation of Union harmonisation legislation under the New Approach requires harmonised standards to offer a guaranteed level of protection with regard to the essential requirements established by the legislation. This constitutes one of the major preoccupations of the Commission in pursuit of its policy for a strong European standardisation process and infrastructure. Regulation (EU) No 1025/2012 on European Standardisation (12) gives the Commission the possibility of requesting, after consultation with the Member States, the European standardisation organisations to draw up harmonised standards and it establishes procedures to assess and to object to harmonised standards.

Since the New Approach calls for common essential requirements to be made mandatory by legislation, this approach is appropriate only where it is possible to distinguish between essential requirements and technical specifications. Further, as the scope of such legislation is risk-related, the wide range of products covered has to be sufficiently homogeneous for common essential requirements to be applicable. The product area or hazards also have to be suitable for standardisation.

The principles of the New Approach laid the foundation for European standardisation in support of Union harmonisation legislation. The role of harmonised standards and the responsibilities of the European standardisation organisations are defined in Regulation (EU) No 1025/2012 together with relevant Union harmonisation legislation.

The principle of reliance on standards in technical regulations has also been adopted by the World Trade Organisation (WTO). In its Agreement on Technical Barriers to Trade (TBT) it promotes the use of international standards (13).

The negotiation of the first Union harmonisation texts under the New Approach immediately highlighted the fact that the determination of essential requirements and the development of harmonised standards were not sufficient to create the necessary level of trust between Member States and that an appropriate horizontal conformity assessment policy and instruments had to be developed. This was done in parallel to the adoption of the directives (14).

Hence in 1989 and 1990 the Council adopted a Resolution on the Global Approach and Decision 90/683/EEC (updated and replaced by Decision 93/465/EEC) (15) laying down the general guidelines and detailed procedures for conformity assessment. These have now been repealed and updated by Decision No 768/2008/EC of 9 July 2008 on a common framework for the marketing of products (16).

The major thrust of these policy instruments was to develop common tools for conformity assessment across the board (for both regulated and non-regulated areas).

The policy on product standards was first developed to ensure that the standards set technical specifications to which conformity could be demonstrated. However, at the request of the Commission, CEN and CENELEC adopted the EN 45000 series of standards for the determination of the competence of third parties involved with conformity assessment. This series has since become the EN ISO/IEC 17000 harmonised series of standards. Under the New Approach legislation a mechanism was set up whereby national authorities notified the third parties they designated to carry out conformity assessments based on recourse to these standards.

On the basis of ISO/IEC documentation, the Council in its Decisions developed consolidated conformity assessment procedures and the rules for their selection and use in directives (the modules). The modules are set out in a manner to favour their selection from the lightest (‘internal control of production’) for simple products or products not necessarily presenting serious risks, moving to the most comprehensive (full quality assurance with EU-design examination), where the risks are more severe or the products/technologies more complex. In order to face up to modern manufacturing processes, the modules foresee both product conformity assessment processes and quality management assessment, leaving the legislator to decide which are the most appropriate in each sector, as it is not necessarily effective to provide for individual certification for each mass produced product, for example. To reinforce the transparency of the modules and their effectiveness, at the request of the Commission, the ISO 9000 series of standards on quality assurance were harmonised at the European level and integrated into the modules. Thus, economic operators who use these tools in their voluntary quality management policies to reinforce their quality image on the market, can benefit from the use of the same tools in the regulated sectors.

These different initiatives were all geared to directly reinforcing the assessment of conformity of products prior to their marketing. Alongside these, the Commission, in close cooperation with the Member States and the national accreditation bodies, developed European cooperation in the field of accreditation in order to constitute a last level of control and reinforce the credibility of the third parties involved in carrying out product and quality assurance conformity assessment. This remained a political, rather than a legislative initiative, but it was nevertheless effective in creating the first European infrastructure in this area, and in placing European players very much in the lead in this field at international level.

These developments led to some 27 directives being adopted on the basis of New Approach elements. They are far fewer in number than traditional directives in the field of industrial products (some 700), but their wide hazard-based scope means that entire industrial sectors have benefited from free movement through this legislative technique.

1.2. The ‘New Legislative Framework’

Towards the end of the 90’s the Commission started to reflect on the effective implementation of the New Approach. In 2002, a wide consultation process was launched and on 7 May 2003 the Commission adopted a Communication to the Council and European Parliament suggesting a possible revision of certain New Approach elements. This in turn led to the Council Resolution of 10 November 2003 on the Communication of the European Commission ‘Enhancing the implementation of the New Approach Directives’ (17).

The consensus on the need for the update and review was clear and strong. The major elements needing attention were also clear: overall coherence and consistency, the notification process, accreditation, the conformity assessment procedures (modules), CE marking and market surveillance (including revision of the safeguard clause procedures).

A Regulation and a Decision constituting part of the ‘Ayral goods package’ (18) were adopted by the European Parliament and the Council on 9 July 2008 (19).

Regulation (EC) No 765/2008 and Decision No 768/2008/EC brought together, in the New Legislative Framework (NLF), all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of industrial products with the requirements adopted to protect the various public interests and for the proper functioning of the single market.

Regulation (EC) No 765/2008 established the legal basis for accreditation and market surveillance and consolidated the meaning of the CE marking, thus filling an existing void. Decision No 768/2008/EC set up a model to be used in preparing and revising Union harmonisation legislation with the aim to update, harmonise and consolidate the various technical instruments already used in existing Union harmonisation legislation (not only in New Approach directives): definitions, criteria for the designation and notification of conformity assessment bodies, rules for the notification process, the conformity assessment procedures (modules) and the rules for their use, the safeguard mechanisms, the obligations of the economic operators and traceability requirements.

The NLF takes account of the existence of all the economic operators in the supply chain –manufacturers, authorised representatives, distributors and importers – and of their respective roles in relation to the product. The importer now has clear obligations in relation to the compliance of products, and where a distributor or an importer modifies a product or markets it under their own name, they become the equivalent of the manufacturer and must take on the latter’s responsibilities in relation to the product.

The NLF also recognises the different facets of the responsibilities of the national authorities: the regulatory authorities, the notification authorities, those which oversee the national accreditation body, the market surveillance authorities, the authorities responsible for the control of products from third countries, etc., underlining that responsibilities depend on the activities carried out.

The NLF has changed the emphasis of EU legislation in relation to market access. Formerly the language of Union harmonisation legislation concentrated on the notion of ‘placing on the market’ which is traditional free movement of goods language, i.e. it focuses on the first making available of a product on the EU market. The NLF, recognising the existence of a single internal market, puts the emphasis on making a product available thus giving more importance to what happens after a product is first made available. This also corresponds to the logic of the putting into place of EU market surveillance provisions. The introduction of the concept of making available facilitates the tracing back of a non-compliant product to the manufacturer. It is important to note that compliance is assessed with regard to the legal requirements applicable at the time of the first making available.

The most important change brought about by the NLF to the legislative environment of the EU was the introduction of a comprehensive policy on market surveillance. This has considerably changed the balance of EU legislative provisions from being fundamentally oriented at setting product related requirements to be met when products are placed on the market to an equal emphasis on enforcement aspects during the whole life-cycle of products. The market surveillance provisions in Regulation (EC) No 765/2008 have now been replaced by Regulation (EU) 2019/1020 aiming at improving and modernising market surveillance.

1.2.1. The modernisation of market surveillance provisions

The new Regulation (EU) 2019/1020 on market surveillance and compliance of products improves and modernises market surveillance. It will apply to 70 regulations and directives (listed in its Annex I) that harmonise at EU level requirements on non-food products to protect consumers, health and safety, the environment and other public interests. Regulation (EU) 2019/1020 replaces the market surveillance provisions of Regulation (EC) No 765/2008 as from 16 July 2021 (see Article 44 of Regulation (EU) 2019/1020), and will improve them in particular by:

— providing information and carrying out activities to promote compliance;

— providing more effective enforcement tools to address online sales; and

— improving cooperation: between Member States, between market surveillance and customs authorities, and through an EU product compliance network.

Regulation (EU) 2019/1020 also provides a comprehensive framework for controls on all products (in harmonised and non-harmonised areas) entering the EU market. That framework applies to products covered by EU law in so far as there are no specific provisions relating to the organisation of controls on products entering the EU market in EU law (see Article 2(2) of Regulation (EU) 2019/1020. This Guide addresses market surveillance in relation to products subject to harmonisation legislation and therefore focuses, for the external dimension, on the control of products covered by harmonisation legislation entering the EU.

1.2.2. The legal nature of the NLF acts and the Market Surveillance legislation and their relationship to other EU legislation

1.2.2.1. Regulation (EC) No 765/2008 and Regulation (EU) 2019/1020

Regulation (EC) No 765/2008 imposes clear obligations on Member States who do not have to transpose its provisions (although many may have to take national measures to adapt their national legal framework). Its provisions are directly applicable to the Member States, to all the economic operators concerned (manufacturers, distributors, importers) and to conformity assessment bodies and accreditation bodies. Economic operators now have not only obligations but direct rights that they can enforce through the national courts against both national authorities and other economic operators for non-respect of the provisions of the Regulation. While the provisions on accreditation and CE marking remain applicable, the provisions on market surveillance in Regulation (EC) No 765/2008 have been repealed and replaced by Regulation (EU) 2019/1020.

In the presence of other EU legislation, both Regulations apply first and foremost, a) on the basis of being directly applicable i.e. national authorities and economic operators must apply the provisions of these Regulations as such (most of the other legislation is contained in directives) and b) on the basis of the lex specialis rule i.e. whenever a matter is regulated by two rules, the more specific one should be applied first.

In the absence of more specific legislation on the issues covered by its provisions, Regulation (EC) No 765/2008 will apply at the same time, with, and as a complement to, existing legislation. Similarly, Regulation (EU) 2019/1020 is based on the lex specialis principle, providing that this Regulation applies insofar as there are no specific provisions with the same objective in Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement (Article 2(1) of Regulation (EU) 2019/1020). Where existing legislation contains similar provisions as the Regulation, the corresponding provisions will have to be examined on a one to one basis to determine which is the most specific.

In general terms, relatively few EU legislative texts contain provisions relating to accreditation, so it can be said that Regulation (EC) No 765/2008 is of general application in this area. In the area of market surveillance (including the control of products from third countries) the situation is more complex, as some Union harmonisation legislation does have various provisions relating to the issues covered by Regulation (EU) 2019/1020 (e.g. legislation on medical devices and on in vitro diagnostic medical devices which provides for a specific information procedure). In many cases, the market surveillance provisions in Union harmonisation legislation are complementary and provisions of Regulation (EU) 2019/1020 remain applicable.

1.2.2.2. Decision No 768/2008/EC

Decision No 768/2008/EC is what is referred to as a sui generis decision, meaning that it has no addressees and therefore is neither directly nor indirectly applicable. It constitutes a political commitment on the part of the three EU institutions, European Parliament, Council and Commission.

This means that for its provisions to apply in Union law, they have to be either referred to expressis verbis (expressly) in future legislation or integrated into it.

The three institutions have indeed committed themselves to adhere to and to have recourse as systematically as possible to its provisions when drawing up product related legislation. Thus, relevant future proposals are to be examined in the light of the Decision and departures from its contents, duly justified.

1.2.3. How the system fits together

The evolution of EU legislative techniques in this area has been progressive, tackling issues one after another, although sometimes in parallel, culminating in the adoption of the New Legislative Framework: essential or other legal requirements, product standards, standards and rules for the competence of conformity assessment bodies as well as for accreditation, standards for quality management, conformity assessment procedures, CE marking, accreditation policy, and lately market surveillance policy including the control of products from third countries.

The New Legislative Framework now constitutes a complete system bringing together all the different elements that need to be dealt with in product safety legislation in a coherent, comprehensive legislative instrument that can be used across the board in all industrial sectors, and even beyond (environmental and health policies also have recourse to a number of these elements), whenever EU legislation is required.

In this system, the legislation has to set the levels of public protection objectives of the products concerned as well as the basic safety characteristics, it should set the obligations and requirements for economic operators, it has to set-where necessary-the level of competence of the third party conformity assessment bodies who assess products or quality management systems, as well as the control mechanisms for these bodies (notification and accreditation), it must determine which are the appropriate conformity assessment processes (modules which also include the manufacturer’s Declaration of Conformity) to be applied, and finally it must impose the appropriate market surveillance mechanisms (internal and external) to ensure that the whole legislative instrument operates in an effective and seamless manner.

All these different elements are interlinked, operate together and are complementary, forming an EU quality (20) chain. The quality of the product depends on the quality of the manufacturing, which in many instances is influenced by the quality of testing, internal or carried out by external bodies, which depends on the quality of the conformity assessment processes, which depends on the quality of the bodies which in turn depends on the quality of their controls, which depends on the quality of notification or accreditation; the entire system depending on the quality of market surveillance and controls of products from third countries.

They should all be treated in one way or another in any piece of EU product safety and market surveillance legislation. If one element goes missing or is weak, the strength and effectiveness of the entire ‘quality chain’ is at stake.

1.3. The General Product Safety Directive

Directive 2001/95/EC on general product safety (GPSD) (21) is intended to ensure product safety throughout the EU for all non-food consumer products to the extent that they are not covered by sector-specific EU harmonisation legislation. The GPSD also complements the provisions of sector legislation in some aspects. The GPSD therefore provides for a safety net ensuring that all non-food consumer products in the EU are safe. The key provision of the GPSD is that producers are obliged to place on the market only safe products. The GPSD also provides for market surveillance provisions aimed at guaranteeing a high level of consumer health and safety protection.

The GPSD has set up the EU Rapid Alert System which is used to quickly exchange information between Member States and the Commission on measures taken against dangerous non-food products (RAPEX). The EU Rapid Alert System ensures that the identified dangerous products are quickly removed from the entire Internal Market. Subject to international agreements and according to administrative arrangements defined in these agreements between the Union and third countries, selected RAPEX notification data can also be exchanged with non-EU countries.

In the case of serious product risks to the health and safety of consumers in various Member States, the GPSD also provides for the possibility for the Commission to take temporary Decisions on Union-wide measures, so-called ‘emergency measures’. Under certain conditions, the Commission may adopt a formal Decision (valid for one year, but renewable for the same period) requiring the Member States to restrict or prevent the marketing of a product posing a serious risk to the health and safety of consumers.

On 30 June 2021, the Commission adopted a proposal for a new General Product Safety Regulation (22), to replace the GPSD.

1.4. The legislation on product liability

The Directive on product liability 85/374/EEC (23) establishes a system of strict liability, i.e. liability without fault, for producers when a defective product causes physical or material damage to an injured person. The producer is liable for damage caused by a defect in his/her product provided that the injured person proves the damage, the defect and the causal relationship between defect and damage. The Directive aims at a full and proper compensation for persons injured by a defective product for the kind of damage referred to in the Directive. The Directive is an important element of the EU product safety legislation framework. It underpins product safety legislation by giving producers incentives to comply with it, as well as legal certainty.

The Directive on product liability does not require Member States to repeal any other legislation on liability. In this respect, the Directive’s regime adds to the existing national rules on liability. It is up to the victim to choose the grounds on which to file the action.

1.5. Scope of the Guide

This Guide discusses non-food and non-agricultural products referred to as industrial products or products whether for use by consumers or professionals. The product-related legislation that deals with these products will be referred throughout the text indistinctly as Union harmonisation legislation, sectoral Union harmonisation legislation or Union harmonisation acts.

The New Legislative Framework consists of a set of legal documents. In particular Decision No 768/2008/EC provides for elements, which are partially or totally implemented in product-related Union harmonisation legislation addressing various public interests. The guide gives guidance for the implementation of the provisions and concepts laid down in the New Legislative Framework (24) as well as for the general application of market surveillance provisions according to Regulation (EU) 2019/1020. Where there are product-specific deviations or provisions the guide refers to sectoral guides, which exist for almost all sectoral Union harmonisation legislation.

The present Guide has the ambition of explaining the different elements of the New Legislative Framework as well as market surveillance in detail and of contributing to a better overall understanding of the system so that legislation is implemented properly and is therefore effective for the protection of public interests such as health and safety, the protection of consumers, the protection of the environment and public security, as well as the proper functioning of the internal market for economic operators. Furthermore, the Guide promotes the goals of the Commission’s better regulation policy by clarifying existing legislation, thus contributing to the development of more comprehensive, coherent and proportionate legislation.

Each of these chapters should be read in conjunction with the explanations set out above, in other words against the general background, and in conjunction with the other chapters, as they are all interlinked and should not be seen in isolation.

This guide primarily relates to the Union legislation on:

— The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU) — Appliances burning gaseous fuels (Regulation (EU) 2016/426) — Ecodesign requirements for energy-related products (Directive 2009/125/EC and all implementing Regulations for specific product groups that have been adopted under this Framework Directive) — Simple pressure vessels (Directive 2014/29/EU) — Toys’ safety (Directive 2009/48/EC) — Electrical equipment designed for use within certain voltage limits (Directive 2014/35/EU) — Machinery (Directive 2006/42/EC) — Electromagnetic compatibility (Directive 2014/30/EU) — Measuring instruments (Directive 2014/32/EU) — Non-automatic weighing instruments (Directive 2014/31/EU) — Cableway installations (Regulation (EU) 2016/424) — Radio equipment (Directive 2014/53/EU) — Medical devices (Regulation (EU) 2017/745, replacing Directives 90/385/EEC and 93/42/EEC as of 26 May 2021) — In vitro diagnostic medical devices (Directive 98/79/EC to be replaced by Regulation (EU) 2017/746 as of 26 May 2022) — Pressure equipment (Directive 2014/68/EU) — Transportable Pressure equipment (Directive 2010/35/EU) — Aerosol Dispensers (Directive 75/324/EEC as amended) — Lifts (Directive 2014/33/EU) — Recreational craft (Directive 2013/53/EU) — Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 2014/34/EU) — Explosives for civil uses (Directive 2014/28/EU) — Pyrotechnics (Directive 2013/29/EU) — Regulation on the Labelling of Tyres (Regulation (EU) No 2020/740) — Personal protective equipment (Regulation (EU) 2016/425) — Marine equipment (Directive 2014/90/EU) — Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC) — Emissions from non-road mobile machinery (Regulation (EU) 2016/1628) — Energy labelling (Regulation (EU) 2017/1369 and all delegated Regulations for specific product groups that have been adopted under this Framework Regulation and those adopted under Directive 2010/30/EU, the predecessor of Regulation 2017/1369) — Fertilising Products (Regulation (EU) 2019/1009) — Unmanned aircraft systems (drones) (Commission Delegated Regulation (EU) 2019/945)

However, elements of this Guide might be relevant for other Union harmonisation legislation going even beyond the realm of products listed above. This is particularly true for the various definitions in the Guide as well as the chapters bearing on standardisation, conformity assessment, accreditation and market surveillance where other Union harmonisation legislation rely on the same definitions or concepts. In particular, chapter 7 on market surveillance will be of relevance for the legislation included in Annex I of Regulation (EU) 2019/1020. A larger list of legislation concerned is provided in Annex 1.

The Guide does not attempt to cover:

— the Directive on General Product Safety (25). Guidelines for the management of the European Union Rapid Information System ‘RAPEX’ have been adopted in 2018 (RAPEX Guidelines) (26),

— the Union legislation on motor vehicles, construction products, REACH, and other chemicals beyond the legislation included in the list above or the general aspects mentioned above, including market surveillance,

— the Union food legislation including the chemical safety of food contact materials.

2. WHEN DOES UNION HARMONISATION LEGISLATION ON PRODUCTS APPLY?

2.1. Product coverage

— Union harmonisation legislation applies when the product is placed on the Union market and to any subsequent operation which constitutes making available until it reaches the end-user. — Union harmonisation legislation applies to all forms of selling. A product offered in a catalogue or by means of electronic commerce has to comply with Union harmonisation legislation when the catalogue or website directs its offer to the Union market and includes an ordering and shipping system. — Union harmonisation legislation applies to newly manufactured products but also to used and second-hand products imported from a third country when they enter the Union market for the first time — Union harmonisation legislation applies to finished products as defined by the scope of each legislation. — A product which has been subject to important changes or overhauls aiming to modify its original performance, purpose or type may be considered as a new product. The person who carries out the changes becomes then the manufacturer with the corresponding obligations.

Union harmonisation legislation applies to products which are intended to be placed (and/or put into service (27)) on the market (28). Furthermore, Union harmonisation legislation applies when the product is placed on the market (or put into service) and to any subsequent making available until the product reaches the end-user (29) (30). A product still in the distribution chain falls under the obligations of the Union harmonisation legislation as long as it is a new product. (31) Once it reaches the end-user it is no longer considered a new product and the Union harmonisation legislation no longer applies. This is without prejudice to the level of safety or other public interest protection that a product must offer when used as intended in relation to the applicable Union harmonisation legislation at the time it was placed on the market, or to any market surveillance measure that may be taken in relation to products which have already been made available to an end user and present a risk (e.g. recalls).

The end-user is not one of the economic operators who bear responsibilities under Union harmonisation legislation i.e. any operation or transaction by the end-user involving the product is not subject to Union harmonisation legislation. However, such an operation or transaction might fall under another regulatory regime, in particular at national level.

The product must comply with the legal requirements that were in place at the time of its placing on the market (or putting into service).

Union harmonisation legislation applies to all forms of supply, including distance selling and selling through electronic means. Hence, regardless of the selling technique, products intended to be made available on the Union market must be in conformity with the applicable legislation.

A product intended to be placed on the Union market, offered in a catalogue or by means of electronic commerce, has to comply with Union harmonisation legislation when the catalogue or website targets its offer to the Union market and includes an ordering and shipping system (32). Products offered for sale online or through other means of distance sales are deemed to be made available on the market if the offer is targeted at end users in the Union. An offer for sale is considered to be targeted at end users in the Union if an economic operator directs, by any means, its activities to a Member State. A case-by-case analysis should be carried out in order to establish whether an offer is targeted at end users in the Union. (33)

The Union harmonisation legislation applies to newly manufactured products but also to used and second-hand products, including products resulting from the preparation for re-use of electrical or electronic waste, imported from a third country when they enter the Union market for the first time (34) (35). This applies even to used and second-hand products imported from a third country that were manufactured before the legislation became applicable.

Used and second-hand products which are on the Union market, and which are supplied to consumers are covered by the GPSD (Article 2(a) of the GPSD) when they are supplied or made available, whether for consideration or not, in the course of a commercial activity, unless the second-hand products are supplied as antiques or as products to be repaired or reconditioned prior to being used, and the supplier has clearly informed the person to whom he supplies the product to that effect. Under the GPSD, producers must ensure that they only place safe products on the market.

The product scope in Union harmonisation legislation

Union harmonisation legislation applies to finished products, as defined by the scope of each specific Union harmonisation legislation. Yet, the concept of product varies between different pieces of Union harmonisation legislation. The objects covered by legislation are referred to, for instance, as products, equipment, apparatus, devices, appliances, instruments, materials, assemblies, components or safety components, units, fittings, accessories, systems or partly completed machinery. Thus, within the terms of a specific Union harmonisation act, components, spare parts or sub-assemblies may be regarded as finished products and their end-use may be the assembly or incorporation into a finished product. If this is the case, such products must comply with the applicable legislation at the time they are placed on the Union market (and/or put into service), that is, when they are first supplied for distribution, consumption or use on the Union market. When a finished product incorporating another product is placed on the Union market, the manufacturer is responsible for the compliance of the complete product with the applicable legislation. The manufacturer of this finished product can rely on the conformity assessment of the integrated product to build the Declaration of Conformity, conformity assessment and documentation of the product.

Unless there are more specific provisions, Union harmonisation legislation applies to the products it defines within its scope, irrespective of whether they are being supplied ready for use or intended for installation.

It is the responsibility of the manufacturer to verify whether or not the product is within the scope of a given piece of Union harmonisation legislation (36) (37).

A combination of products and parts, which each comply with applicable legislation, does not always constitute a finished product that has to comply itself as a whole with a given Union harmonisation legislation. However, in some cases, a combination of different products and parts designed or put together by the same person is considered as one finished product which has to comply with the legislation as such. In particular, the manufacturer of the combination is responsible for selecting suitable products to make up the combination, for putting the combination together in such a way that it complies with the provisions of the laws concerned, and for fulfilling all the requirements of the legislation in relation to the assembly, the EU Declaration of Conformity and CE marking. The fact that components or parts are CE marked does not automatically guarantee that the finished product also complies. Manufacturers must choose components and parts in such a way that the finished product itself complies. The manufacturer must verify on a case-by-case basis whether a combination of products and parts has to be considered as one finished product in relation with the scope of the relevant legislation.

If there are two or more finished products made available in the same package which do not constitute a single finished product but which are intended to function together, the manufacturer marketing the combination must address the risks of the products included in the package when used in operation with each other.

Repairs and modifications to products

After they are placed on the market, products may be subject to life extension processes. While some of these processes intend to maintain or restore the product to its original condition, others imply that substantial modifications are made to the product.

A product, which has been subject to important changes or overhaul after it has been put into service must be considered as a new product if: i) its original performance, purpose or type is modified, without this being foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased in relation to the relevant Union harmonisation legislation; and iii) the product is made available (or put into service if the applicable legislation also covers putting into service within its scope). This has to be assessed on a case-by-case basis and, in particular, in view of the objective of the legislation and the type of products covered by the legislation in question.

Where a modified product (38) is considered as a new product, it must comply with the provisions of the applicable legislation when it is made available or put into service. This has to be verified by applying the appropriate conformity assessment procedure laid down by the legislation in question. In particular, if the risk assessment leads to the conclusion that the modified product has to be considered as a new product, then the compliance of the modified product with the applicable essential requirements has to be reassessed and the person carrying out the substantial modification has to fulfil the same requirements as an original manufacturer, for example preparation of the technical documentation, drawing up a EU declaration of conformity and affixing the CE marking on the product.

In any case, a modified product sold under the name or trademark of a natural or legal person different from the original manufacturer, should be considered as new and subject to Union harmonisation legislation. The person who carries out important changes to the product carries the responsibility for verifying whether or not it should be considered as a new product in relation to the relevant Union harmonisation legislation. If the product is to be considered as new, this person becomes the manufacturer with the corresponding obligations. Furthermore, in the case the conclusion is that it is a new product, the product has to undergo a full conformity assessment before it is made available on the market and the new manufacture’s name and contact address must be indicated on the product. However, the technical documentation has to be updated in as much as the modification has an impact on the requirements of the applicable legislation. It is not necessary to repeat tests and produce new documentation in relation to aspects not impacted by the modification. It is up to the natural or legal person who carries out changes or has changes carried out to the product to demonstrate that not all elements of the technical documentation need to be updated. The natural or legal person who carries out changes or has changes carried out to the product shall be responsible for the conformity of the modified product and draw a declaration of conformity, even if they use existing tests and technical documentation.

Products which have been repaired (for example following a defect), without being considered as new products do not need to undergo conformity assessment again, whether or not the original product was placed on the market before or after the legislation entered into force. This applies even if the product has been temporarily exported to a third county for the repair operations. For certain products, manufacturers are required to provide spare parts to other third parties to perform the repairs, and for a certain minimum period of time (39). Such repair operations are often carried out by replacing a defective or worn item by a spare part, which is either identical, or at least similar, to the original part (for example modifications may have taken place due to technical progress, or discontinued production of the old part), by exchanging cards, components or sub-assemblies. If the original performance of a product is modified (within the intended use, range of performance and maintenance originally conceived at the design stage) because the spare-parts used for its repair perform better due to technical progress, this product is not to be considered as new according to Union harmonisation legislation. Thus, maintenance operations are basically excluded from the scope of the Union harmonisation legislation. However, at the design stage of the product the intended use and maintenance must be taken into account (40).

Software

Software is today essential for the functioning of products. Under the medical device and in vitro medical devices legislation, software in its own right presenting certain features is considered as a medical device or an in vitro diagnostic medical device (41). Certain pieces of Union harmonisation legislation refer explicitly to the software integrated in the product (42).

As part of the initial risk assessment, the manufacturer of the final product has obligations to foresee the risks of software integrated in that product at the time of its placing on the market. The concept of product safety encompasses protection against all kinds of risks arising from the product, including not only mechanical, chemical, electrical risks but also the safety-related aspects of cyber risks and risks related to the loss of connectivity of devices.

Software updates or repairs could be assimilated to maintenance operations provided that they do not modify a product already placed on the market in such a way that compliance with the applicable requirements may be affected. As is the case for physical repairs or modifications, a product should be considered as substantially modified by a software change where: i) the software update modifies the original intended functions, type or performance of the product and this was not foreseen in the initial risk assessment; ii) the nature of the hazard has changed or the level of risk has increased because of the software update; and iii) the product is made available (or put into service where this is covered by the specific Union harmonisation legislation).

2.2. Making available on the market

— A product is made available on the market when supplied 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. — The concept of making available refers to each individual product.

A product is made available on the market when supplied 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. (43) Such supply includes any offer for distribution, consumption or use on the Union market which could result in actual supply in relation to products already manufactured (e.g. an invitation to purchase, advertising campaigns).

Supplying a product is only considered as making available on the Union market, when the product is intended for end use on the Union market. The supply of products (whether for further distribution, for incorporation into a final product or for further processing or refinement) with the aim to export the final product outside the Union market is not considered as making available. Commercial activity is understood as providing goods in a business related context. Non-profit organisations may be considered as carrying out commercial activities if they operate in such a context. This can only be appreciated on a case by case basis taking into account the regularity of the supplies, the characteristics of the product, the intentions of the supplier, etc. In principle, occasional supplies by charities or hobbyists should not be considered as taking place in a business related context.

‘Use’ refers to the intended purpose of the product as defined by the manufacturer under conditions which can be reasonably foreseen. Usually, this is the end use of the product.

The central role that the concept of making available plays in Union harmonisation legislation is related to the fact that all economic operators in the supply-chain have traceability obligations and need to have an active role in ensuring that only compliant products circulate on the Union market.

The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.

The making available of a product supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right (44) concerning the product in question after the stage of manufacture has taken place. The transfer does not necessarily require the physical handover of the product.

This transfer can be for payment or free of charge, and it can be based on any type of legal instrument. Thus, a transfer of a product is considered to have taken place, for instance, in the circumstances of sale, loan, hire (45), leasing and gift. Transfer of ownership implies that the product is intended to be placed at the disposal of another legal or natural person.

2.3. Placing on the market

— A product is placed on the market when it is made available for the first time on the Union market. According to Union harmonisation legislation, each individual product can only be placed once on the Union market. — Products made available on the market must comply with the applicable Union harmonisation legislation at the moment of placing on the market.

For the purposes of Union harmonisation legislation, a product is placed on the market when it is made available for the first time on the Union market. This operation should be done by the manufacturer or by an importer (46). When a manufacturer or an importer supplies a product to a distributor (47) or an end-user for the first time, the operation is always labelled in legal terms as ‘placing on the market’. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.

As for ‘making available’, the concept of placing on the market refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series. Consequently, placing on the Union market can only happen once for each individual product across the EU and does not take place in each Member State. Even though a product model or type has been supplied before new Union harmonisation legislation laying down new mandatory requirements entered into force, individual units of the same model or type, which are placed on the market after the new requirements have become applicable, must comply with these new requirements.

Placing a product on the market requires an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question; it requires that the manufacturing stage has been completed. This transfer could be for payment or free of charge. It does not require the physical handover of the product. Sometimes products are manufactured following the placing of an order. An offer or agreement concluded before the stage of manufacture has been finalised cannot be considered as placing on the market (e.g. an offer to manufacture a product according to certain specifications agreed by the parties to the contract, where the product will only be manufactured and delivered at a later stage).

Placing on the market is considered not to take place where a product is:

— manufactured for one’s own use unless Union harmonisation legislation covers products manufactured for own use in its scope (48) (49);

— bought by a consumer in a third country while physically present in that country (50) and brought by the consumer into the EU for the personal use of that person;

— transferred from the manufacturer in a third country to an authorised representative in the Union whom the manufacturer has engaged to ensure that the product complies with the Union harmonisation legislation (51);

— introduced from a third country in the EU customs territory in transit, placed in free zones, warehouses, temporary storage or other special customs procedures (temporary admission or inward processing) (52);

— manufactured in a Member State with a view to exporting it to a third country (this includes components supplied to a manufacturer for incorporation into a final product to be exported into a third country);

— transferred for testing or validating pre-production units considered still in the stage of manufacture;

— displayed or operated under controlled conditions (53) at trade fairs, exhibitions or demonstrations (54); or

— in the stocks of the manufacturer (or the authorised representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonisation legislation.

The placing on the market is the most decisive point in time concerning the application of the Union harmonised legislation (55). When made available on the Union market, products must be in compliance with the Union harmonisation legislation applicable at the time of placing on the market. Accordingly, new products manufactured in the Union and all products imported from third countries (56) – whether new or used – must meet the provisions of the applicable Union harmonisation legislation when placed on the market i.e. when made available for the first time on the Union market. Compliant products once they have been placed on the market may subsequently be made available along the delivery chain without additional considerations, even in case of revisions to the applicable legislation or the relevant harmonised standards, unless otherwise specified in the legislation.

Member States have an obligation in the framework of market surveillance to ensure that only safe and compliant products are on the market (57). Used products, which are on the Union market, are subject to free movement according to the principles laid down by Articles 34 and 36 TFEU. It must be noted that used products made available to consumers in the course of a commercial activity are subject to the GPSD, unless they are supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that the supplier has clearly informed the person to whom he supplies the product to that effect.

2.4. Making available and placing on the market in case of distance and online sales

Products offered for sale online or through other means of distance sales are deemed to be made available on the Union market if the offer is targeted at end users in the Union (58). This means that market surveillance authorities are empowered to check and take the necessary actions in relation to such products in accordance with Regulation (EU) 2019/1020 (see chapter 7 below). An offer for sale is 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. The assessment of whether or not a website located inside or outside the EU targets EU end-users has to be carried out on a case-by-case basis, taking into account any relevant factors such as the geographical areas to which dispatch is possible, the languages available used for the offer or for ordering, payment possibilities, etc. The mere fact that the economic operators’ or the intermediaries’ website is accessible in the Member State in which the end user is established or domiciled is insufficient (59). When an online interface provides for delivery in the EU, accepts payment by EU consumers/end-users and uses EU languages, then it can be considered that the operator has expressly chosen to supply products to EU consumers or other end-users. The physical delivery to end-users in the EU of a product ordered from a given online seller based outside the EU, including by a fulfilment service provider, gives irrefutable confirmation that a product is placed on the EU market.

The legal consequence is that, if the offer is targeted at end users in the Union, products offered for sale online or through other means of distance sales need to comply with all applicable EU rules and can be subject to checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020. The economic operator offering the product for sale online or through other means of distance sales is required to cooperate with the market surveillance authorities upon their request for compliance information or for other actions (60). If products are sold online, it is useful that the CE marking and any required warnings according to applicable legislation are indicated in that website and visible before the end user is carrying out the purchase.

Online or distance selling may be a specific manner of making products available but it does not necessarily constitute the first making available of the product on the Union market (i.e. the placing on the market). The actual placing on the market of these products may differ for each individual product, depending on the specific distribution chain, for example:

— The distance sale or online offer may refer to products that have already been placed on the Union market. This is the case where the EU manufacturer or an importer has already placed them on the Union market before they were offered for sale online or through other means of distance selling.

— Some products offered online or through other means of distance selling to end users in the Union are transferred first to fulfilment service providers located in the EU to guarantee their swift delivery to EU end users. Accordingly, products stored by such fulfilment service providers and released for free circulation are considered to have been supplied for distribution, consumption or use on the EU market and thus placed on the EU market. When an online operator uses a fulfilment service provider in this manner, by shipping the products to the fulfilment house in the EU, the products are in the distribution phase of the supply chain (61). These products are considered placed on the market at the time they are released for free circulation.

— Some products outside the EU can be bought directly by end-users in the EU online or through other means of distance sales. Although these products are deemed to be made available in the Union prior to any transaction for the purposes of checks by market surveillance authorities pursuant to Regulation (EU) 2019/1020, they are placed on the market at the moment an order by an end user has been placed and confirmed for a specific product already manufactured and subject of the transaction, and ready to be shipped.

2.5. Products imported from countries outside the EU

Irrespective of their origin products must be compliant with the applicable Union harmonisation legislation if they are made available on the Union market. Products coming from countries outside the EU intended to be placed on the Union market or intended for private use or consumption in the Union customs territory are declared for release for free circulation and may be checked by authorities designated for controls on products entering the Union market.

The basic principle of EU harmonisation legislation is that irrespective of the origin of the products, they need to be compliant with the applicable Union harmonisation legislation if they are made available (or put into service (62)) on the Union market. Products manufactured in the EU and products from non-EU countries are treated alike.

Union harmonisation legislation applies to products outside the Union when they are made available on the Union market for the first time; not only to newly manufactured products but also to used and second-hand products, including products resulting from the preparation for re-use of electrical or electronic waste, but not to such products already on the EU market. It applies even to used and second-hand products imported from a third country that were manufactured before the Union harmonisation legislation became applicable.

Before they can reach the end-user in the EU, products from countries outside the EU will be presented to customs and declared for the release for free circulation procedure. The purpose of release for free circulation is to fulfil all import formalities so that the goods can be made available on, and circulate freely in the EU market like any product made in the EU. Therefore, when products are presented to customs and declared for the release for free circulation procedure, it can generally be considered that the goods are being placed on the EU market; the products will thus need to be compliant with the applicable Union harmonisation legislation. However, in practice, the release for free circulation and the placing on the market may not take place at the same time. The placing on the market is the moment in which the product is supplied for distribution, consumption or use for the purposes of compliance with Union harmonisation legislation. Placing on the market can take place before the release for free circulation, for example, in the case of online or distance sales by economic operators located outside the EU, even if the physical check of the compliance of the products can take place at the earliest when they arrive at the customs in the EU. Placing on the market can also take place after release for free circulation.

Products that entered the Union territory and require further processing in order to be in compliance with the applicable Union harmonisation legislation should be placed under the appropriate customs procedure allowing for such processing (63). They can be declared for free circulation only after they have been made compliant.

The authorities designated for controls on products entering the Union market and market surveillance authorities have the obligation and the power, based on risk analyses, to check products arriving from third countries and to intervene as appropriate before their release for free circulation, irrespective of when they are de facto placed on the Union market. This is to prevent the release for free circulation and thus the making available in the EU territory of products that are not in compliance with the relevant Union harmonisation legislation or present serious risks to health, safety, the environment or other public interests (64). However, the release for free circulation should not be considered to be proof of conformity with Union harmonisation legislation, as such release does not necessarily include a complete check of compliance. Products imported from countries outside the EU may therefore be subject to subsequent checks, requests and decisions by market surveillance authorities in accordance with Regulation (EU) 2019/1020. Where customs authorities at the first point of entry have reasons to believe that products arriving from third countries and either in temporary storage or placed under a customs procedure other than ‘release for free circulation’ are not compliant with applicable Union harmonisation legislation or present a risk, they are required to transmit all relevant information to the competent customs office of destination.

For products imported from countries outside the EU, Union harmonisation legislation envisages a special role for the importer. The latter assumes certain obligations which to some extent mirror the obligations of manufacturers based within the EU (65).

In the case of products imported from countries outside the EU, an authorised representative may carry out a number of tasks on behalf of the manufacturer (66). If however, the authorised representative of a third country manufacturer supplies a product to a distributor or a consumer within the EU, he then no longer acts as a mere authorised representative but becomes the importer and is subject to the obligations of importers. Furthermore, in order to place the products falling under the scope of Article 4 of Regulation (EU) 2019/1020 on the Union market it is required that there is an economic operator established in the Union and responsible for a number of tasks in relation to those products (67).

2.6. Putting into service or use (and installation)

— The moment of putting into service is relevant for some Union harmonisation legislation. — Putting into service takes place at the moment of first use within the Union by the end user for the purposes for which it was intended.

Putting into service takes place at the moment of first use within the Union by the end user for the purposes for which it was intended (68) (69). The concept is used, for example, in the field of Lifts, Machinery, Radio equipment, Measuring instruments, Medical devices, in vitro diagnostic medical devices or products covered by the EMC or ATEX-Directives, in addition to placing on the market, and results in the scope of Union harmonisation legislation being extended beyond the moment of making available of a product.

Where the product is put into service by an employer for use by his employees, the first use is considered as putting into service.

Member States may not prohibit, restrict or impede the putting into service of products that meet the provisions of the applicable Union harmonisation legislation (70). However, Member States are allowed to maintain and adopt, in compliance with the Treaty (in particular Articles 34 and 36 TFEU) and subject to Union harmonisation legislation, additional national provisions regarding the putting into service, installation or use, of products. Such national provisions may not require modifications of a product manufactured in accordance with the provisions of the applicable Union harmonisation legislation or prevent that products complying with Union harmonisation legislation can be made available in that Member State.

Unless otherwise provided for in specific Union legislation, where products have been placed on the market in compliance with the Union harmonisation legislation applicable at that time, they can also be put into service even if that legislation has been amended after the products are placed on the EU market and therefore they do not entirely comply with the new EU legislation. The need to demonstrate compliance of products at the moment of putting into service, and – if applicable – that they are correctly installed, maintained and used for the intended purpose, should be limited to products:

— which have not been placed on the market prior to their putting into service (for example products manufactured for own use where own use is within the scope of the applicable Union harmonisation legislation) or which can be used only after an assembly, an installation or other manipulation has been carried out; or

— whose compliance can be influenced by the distribution conditions (for example storage or transport).

2.7. Simultaneous application of Union harmonisation acts

— Essential and other requirements laid down in Union harmonisation legislation may overlap or complement each other, depending on the hazards covered by these requirements that are related to the product in question. — The making available or putting into service can only take place when the product complies with the provisions of all applicable Union harmonisation legislation at the time of its placing on the market. — Where the same product or policy objective is covered by two or more Union harmonisation acts, the application of some of the acts can sometimes be excluded following an approach that includes a risk analysis of the product with a view to intended use as defined by the manufacturer.

Union harmonisation legislation covers a wide range of products, hazards and impacts (71), which both overlap and complement each other. As a result, the general rule is that several pieces of legislation may have to be taken into consideration for one product, since the making available or putting into service can only take place when the product complies with all applicable provisions and when the conformity assessment has been carried out in accordance with all applicable Union harmonisation legislation.

Hazards covered by the requirements of various Union harmonisation acts would typically concern different aspects that in many cases complement each other (for example the Directives relating to Electromagnetic Compatibility and Pressure Equipment cover phenomena not covered by the Directives relating to Low-voltage Equipment or Machinery). This calls for a simultaneous application of the various legislative acts. Accordingly, the product has to be designed and manufactured in accordance with all applicable Union harmonisation legislation, as well as to undergo the conformity assessment procedures according to all applicable legislation, unless otherwise provided for.

Certain Union harmonisation acts exclude from their scope products covered by other acts (72) or incorporate the essential requirements of other acts (73) which avoids simultaneous application of redundant requirements. In other instances, this is not the case and the general principle of simultaneous application still applies where the requirements of the Union harmonisation acts are complementary to each other.

Two or more Union harmonisation acts can cover the same product, hazard or impact. In such a case, the issue of overlap might be resolved by giving preference to the more specific Union harmonisation act (74). This usually requires a risk analysis of the product, or sometimes an analysis of the intended purpose of the product, which then determines the applicable legislation. In specifying the hazards relating to a product, the manufacturer may use the relevant harmonised standards applicable for the product in question.

2.8. Reasonably foreseeable and intended use / misuse

Manufacturers have to match a level of protection corresponding to the use they prescribe to the product under the conditions of use which can be reasonably foreseen.

Union harmonisation legislation applies in the case products made available or put into service (75) on the market are used for their intended use. Intended use means the use for which a product is intended in accordance with the information provided by the manufacturer (or importer) placing it on the market, or the ordinary use as determined by the design and construction of the product.

Usually products are ready for use, or require only adjustments that can be performed in view of their intended use. Products are ‘ready for use’ if they can be used as intended without the insertion of additional parts. Products are also deemed ready for use if all parts from which they are to be assembled are placed on the market by one person only, or they only need to be mounted or plugged in, or they are placed on the market without the parts that are usually procured separately and inserted for the intended use (e.g. a cable for electric supply).

Manufacturers are required to match a level of protection for the users of the products or of other public interests which corresponds to the use that the manufacturer prescribes for the product in the product information. This is particularly relevant in the cases where a misuse of a product is at stake (76).

As far as market surveillance activities are concerned, market surveillance authorities are required to check the conformity of a product:

— in accordance with its intended purpose (as defined by the manufacturer) and

— under the conditions of use which can be reasonably foreseen (77), that is when such use could result from lawful and readily predictable human behaviour.

The consequence for manufacturers is that they have to consider the conditions of use which can be reasonably foreseen prior to placing a product on the market.

Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product (78). For products intended for outdoor use, they should also consider how projections about the changing climate in the EU will affect the safety and performance of the product during use. Since the climate is already changing, outdated assumptions based on historical observations and performance should be revised. If the product’s typical life-span extends beyond 5 years, manufacturers may want to prepare it also for more extreme conditions expected in the mid-term. (79)

It is also important that market surveillance authorities take into account that not all risks can be prevented by product design. The supervision and assistance of the intended users should be considered as part of the conditions which can be reasonably foreseen. For instance, some professional machine tools are intended for use by averagely skilled and trained workers under the supervision of their employer; the responsibility of the manufacturer cannot be engaged if such machine tools are rented by a distributor or third party service-provider for use by unskilled and untrained consumers.

In any case, the manufacturer is not obliged to expect that users will not take into consideration the lawful conditions of use of his product.

2.9. Geographical application (EEA EFTA States, Overseas Countries and Territories (OCTs), Turkey)

— Union harmonisation legislation applies to the Member States of the EU and to certain European territories to the extent necessary to give effect to the arrangements set out in the Accession Treaty of the relevant Member States. — The Agreement on the European Economic Area is established between the European Union and Iceland, Liechtenstein and Norway. The Agreement extends the internal market to these three EFTA States – commonly known as EEA EFTA States. — The Customs Union Agreement between the EU and Turkey aims to ensure the free movement of products between the EU and Turkey, by eliminating import controls at the EU-Turkey border on such products. — The Protocol on Ireland and Northern Ireland of the Agreement on the Withdrawal of the UK from the EU extends also the application of certain Union product legislation to Northern Ireland.

2.9.1. Member States and Overseas countries and territories

The purpose of Union harmonisation legislation relating to goods adopted pursuant to Articles 114 and 115 TFEU is the establishment and functioning of the internal market for goods. Consequently, Union harmonisation legislation cannot be separated from Treaty provisions on free movement of goods and the territorial scope of application of Union harmonisation legislation should coincide with the territorial scope of application of Articles 30 and 34 to 36 TFEU.

Pursuant to Article 355 TFEU and in connection with the Article 52 of the Treaty on European Union (TEU), the Treaty and consequently the Union harmonisation legislation applies to all Member States of the European Union. Pursuant to Article 355(1) TFEU it also applies to Guadeloupe, French Guyana, Martinique, Réunion, Mayotte, Saint-Martin, the Azores, Madeira and the Canary Islands. Moreover, the Treaty and harmonisation legislation relating to products adopted on the basis of Articles 114 and 115 TFEU applies to certain European territories to the extent necessary to give effect to the arrangements set out in the relevant Accession Treaty.

However, it does not apply to Faeroe Islands, Greenland, Akrotiri and Dhekelia. The Union harmonisation legislation does not apply to overseas countries and territories, in particular: New Caledonia and Dependencies, French Polynesia, French Southern and Antarctic Territories, Wallis and Futuna Islands, Saint Pierre and Miquelon, Saint-Barthélemy, Aruba, Curaçao, Sint Maarten, Caribbean Netherlands (Bonaire, Saba and Sint Eustatius).

2.9.2. EEA EFTA States

2.9.2.1. Basic elements of the Agreement on the European Economic Area

The Agreement on the European Economic Area, in force since 1 January 1994, covers all Union harmonisation legislation to which this Guide is applicable. Thus, Union harmonisation legislation covered by this Guide also applies to the so-called EEA EFTA States: Iceland, Liechtenstein and Norway.

The objective of the EEA Agreement is to establish a dynamic and homogeneous European Economic Area, based on common rules and equal conditions of competition.

Rights conferred and obligations imposed upon the Member States, or their public entities, undertakings, or individuals in relation to each other, are, according to the EEA Agreement and pursuant to its alignment to new Union legislation through a decision by the Joint Committee, understood to be conferred or imposed in the same way also upon the EEA EFTA States. This ensures that the EEA EFTA States, and their economic operators, are subject to the same rights and obligations as their counterparts in the Union. For instance, the New Approach directives and other Union harmonisation legislation are implemented and applied in exactly the same way in the EEA EFTA States as in the Member States — although the safeguard clause is modified. Therefore, all guidance applicable to the Member States according to this Guide applies also to the EEA EFTA States.

The EEA Agreement is amended on a continuous basis through decisions of the EEA Joint Committee following changes in relevant Union legislation. To arrive at and maintain a uniform interpretation and application of the Agreement, an EFTA Court and an EFTA Surveillance Authority have been established.

The EEA Agreement ensures a close cooperation between the Commission and the administration of the EEA EFTA States. The Commission seeks informal advice from experts of these States in the same way as it seeks advice from experts of the Member States. As regards the committees assisting the Commission in its work, close cooperation has been established. The EEA Council meets biannually, and the EEA Joint Parliamentary Committee and the EEA Consultative Committee regularly.

2.9.2.2. Safeguard clause procedure

The EFTA Surveillance Authority is responsible for the examination of the safeguard clause notifications from the EEA EFTA States. The Authority consults all parties concerned and exchanges information with the Commission on the proceedings of the case. The Authority transmits its decision to the EEA EFTA States and the Commission for further actions. If an EEA EFTA State does not follow the decision, the Surveillance Authority can initiate an infringement procedure.

In cases where a Member State triggers a safeguard clause, consultations between the Commission and the Surveillance Authority are envisaged. The Commission communicates its decision to the EFTA Surveillance Authority, which sends it to the EEA EFTA States for further actions. If an EEA EFTA State does not follow the decision, the Surveillance Authority can initiate an infringement procedure.

2.9.3. Monaco, San Marino and Andorra

Bilateral trade in products between the EU and Monaco, San Marino and Andorra, is facilitated by customs union agreements: Monaco has customs union with France and is part of the customs territory of the EU; whereas San Marino and Andorra both have a customs union agreement with the EU.

However, in order to be made available on the Union market, products from these countries must comply with the EU acquis (80).

2.9.4. Turkey

Turkey and the EU established a Customs Union in 1995 (Decision 1/95 of the EU-Turkey Association Council, 96/142/EC). The Customs Union Decision covers trade in manufactured products and processed agricultural products between Turkey and the EU, and entails alignment by Turkey with all EU product legislation. The Agreement aims to ensure the free movement of manufactured products and processed agricultural products between the EU and Turkey, by eliminating import controls at the EU-Turkey border on such products.

Articles 5 to 7 of the Decision provide for the elimination of measures having an effect equivalent to customs duties between the European Union and Turkey, mirroring Articles 34-36 TFEU. Pursuant to Article 66 of the Decision, its Articles 5 to 7 must, for the purposes of their implementation and application to products covered by the Customs Union Decision, be interpreted in conformity with the relevant case law of the Court of Justice of the European Union, most notably the Cassis de Dijon case on mutual recognition.

As a consequence, in the sectors for which Turkey has aligned its legislation with that of the EU, a product lawfully manufactured and/or marketed in Turkey should be treated equal to a product lawfully manufactured and/or marketed in the EU and should not be subject to import controls. The same reasoning would apply in the non-harmonised sectors where Turkey has aligned its legislation with Articles 34-36 TFEU.

The Decision also requires Turkey to adopt European Union legislation on products and on quality infrastructure, notably on CE marking requirements, notified bodies, market surveillance, accreditation, standardisation, metrology and mutual recognition in the non-harmonised area.

Another Decision (Decision No 2/97 of the EC-Turkey Association Council) signed in 1997 lays down the list of the Union’s legal instruments, including part of the acquis on industrial products related to the removal of technical barriers to trade and the conditions and arrangements governing their implementation by Turkey. Annex I of this Decision ensures that when Turkey adopted the legislation listed in Annex II of the Decision, the same rules and procedures would apply in the EU and Turkey for products that fall within the scope of the legislation listed in Annex II of the Decision. However, many of the Union legislative instruments set out in Annex II have been gradually replaced by new Union directives and regulations.

In 2019 the EU-Turkey Association Council adopted the product-related list of Union technical legislation to be harmonised by Turkey, as decided by the 2014 ‘Procedural Guideline on the Implementation of Article 8 and 9 of Decision 1/95 of the EC-Turkey Association Council of 22 December 1995 on implementing the final phase of the Customs Union’.

In 2006, the EU-Turkey Association Council adopted a Decision (1/2006), providing for the designation of Turkish notified bodies and recognition of the test reports and certificates issued by such bodies in Turkey. The Parties have signed statements confirming that Turkey’s legislation is equivalent to that of the EU for a number of New Approach directives and regulations.

In the non-harmonised area, the rights and obligations of economic operators supplying products to the EU market from Turkey have been laid down in the Commission’s interpretative communication on ‘facilitating the access of products to the markets of other Member States: the practical application of mutual recognition’ (2003/C 265/02).

The Turkish Accreditation Agency (TURKAK) is a member of European co-operation for Accreditation (EA) and has signed a number of mutual recognition agreements with EA. Certificates issued by Turkish conformity assessment bodies accredited by TURKAK should be deemed equivalent to those issued by conformity assessment bodies established in the EU and accredited by EU National Accreditation Bodies.

In the area of standardisation, both CEN and CENELEC granted full membership status to the Turkish Standards Institute (TSE) on 1st January 2012. ETSI’s direct membership is drawn from 65 countries, including Turkey.

2.9.5. Withdrawal of the United Kingdom from the EU (81)

Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a ‘third country’. The Withdrawal Agreement (82) provided for a transition period ending on 31 December 2020. Further information can be found in the Commission Notice to stakeholders on the withdrawal of the United Kingdom and EU rules in the field of industrial products (83)

2.9.5.1. Relevant separation provisions

The Withdrawal Agreement provides for certain separation provisions relevant to industrial products. In particular, Article 41 of the Withdrawal Agreement provides that an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end-user. Where provided in the applicable provisions of Union law, such a good may also be put into service in the EU or in the United Kingdom.

2.9.5.2. Legal situation as of the end of the transition period

As of 1 January 2021, Union harmonisation legislation no longer applies to the United Kingdom. This has in particular the following consequences:

a) Economic operators

A manufacturer or importer established in the United Kingdom is no longer considered as an