Commission notice The ‘Blue Guide’ on the implementation of EU product rules 2022 (Text with EEA relevance) 2022/C 247/01
Date: 2022-06-29
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: European Economic Area, consumer protection, free movement of goods, launching of a product, market approval, market supervision, marketing standard, mutual recognition principle, single market, standardisation




C_2022247EN.01000101.xml










29.6.2022   


EN


Official Journal of the European Union


C 247/1






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:











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The restriction of the use of certain hazardous substances in electrical and electronic equipment (Directive 2011/65/EU)










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Appliances burning gaseous fuels (Regulation (EU) 2016/426)










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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)










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Simple pressure vessels (Directive 2014/29/EU)










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Toys’ safety (Directive 2009/48/EC)










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Electrical equipment designed for use within certain voltage limits (Directive 2014/35/EU)










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Machinery (Directive 2006/42/EC)










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Electromagnetic compatibility (Directive 2014/30/EU)










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Measuring instruments (Directive 2014/32/EU)










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Non-automatic weighing instruments (Directive 2014/31/EU)










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Cableway installations (Regulation (EU) 2016/424)










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Radio equipment (Directive 2014/53/EU)










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Medical devices (Regulation (EU) 2017/745, replacing Directives 90/385/EEC and 93/42/EEC as of 26 May 2021)










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In vitro diagnostic medical devices (Directive 98/79/EC to be replaced by Regulation (EU) 2017/746 as of 26 May 2022)










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Pressure equipment (Directive 2014/68/EU)










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Transportable Pressure equipment (Directive 2010/35/EU)










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Aerosol Dispensers (Directive 75/324/EEC as amended)










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Lifts (Directive 2014/33/EU)










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Recreational craft (Directive 2013/53/EU)










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Equipment and protective systems intended for use in potentially explosive atmospheres (Directive 2014/34/EU)










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Explosives for civil uses (Directive 2014/28/EU)










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Pyrotechnics (Directive 2013/29/EU)










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Regulation on the Labelling of Tyres (Regulation (EU) No 2020/740)










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Personal protective equipment (Regulation (EU) 2016/425)










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Marine equipment (Directive 2014/90/EU)










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Noise emission in the environment by equipment for use outdoors (Directive 2000/14/EC)










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Emissions from non-road mobile machinery (Regulation (EU) 2016/1628)










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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)










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Fertilising Products (Regulation (EU) 2019/1009)










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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),










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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,










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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












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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.











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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.











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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











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Union harmonisation legislation applies to finished products as defined by the scope of each legislation.











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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.











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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.











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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);










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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;










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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);










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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);










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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);










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










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










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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.










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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 economic operator established in the Union. An economic operator established in the Union who, prior to the end of the transition period, was considered as an EU distributor of products received from the United Kingdom has become an importer for the purposes of Union product legislation in relation to products it places on the Union market after 1 January 2021. This operator has to comply with the more stringent obligations applicable to an importer, as regards in particular verification of product compliance and, where applicable, the indication of his contact details on the product or its label (84).
In some product areas, Union harmonisation legislation foresees certain economic operators with specific tasks and who must be established in the Union, for example authorised representatives, whose appointment by the manufacturer is generally voluntary, with the exception of medical devices (85) and marine equipment (86). These can no longer be established in the UK and must be established in the Union.
b)   Conformity assessment procedures and notified bodies (87)

Former UK Notified Bodies have lost their status as EU Notified Bodies. As such, UK bodies are no longer in a position to perform conformity assessment tasks pursuant to Union product legislation.
When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by an EU Notified Body is required for products placed on the Union market as of 1 January 2021.
Economic operators must have applied for a new certificate to an EU Notified Body, or arranged for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU Notified Body, to take over the responsibility for that certificate before the end of the transition period, on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU Notified Body.
When a certificate has been transferred, both the EU Declaration of Conformity (drawn up by the manufacturer) and the Notified Body Certificate must be updated accordingly: these documents will need to mention that the certificate is now under the responsibility of an EU Notified Body and indicate both the old UK and the new EU Notified Body’s details / identification numbers.
If the above mentioned product documentation is in order, there is no need to change the Notified Body number for products already placed on the EU or the UK market or manufactured before the transfer of certificate took place and not yet placed on the EU or the UK market. However, products manufactured after the transfer of the certificate has taken place should be marked with the new EU Notified Body number and it will not be possible to continue to use the UK Notified Body number. (88)

c)   Accreditation (89)

The UK Accreditation Service ceased to be a national accreditation body within the meaning and for the purposes of Regulation No 765/2008 as from the end of the transition period. As a consequence, its accreditation certificates are no longer considered as ‘accreditation’ within the meaning of Regulation No 765/2008 and no longer valid or recognised in the EU pursuant to that Regulation as of 1 January 2021.
2.9.6.   
Northern Ireland


As from 1 January 2021, the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) applies. (90) The IE/NI Protocol is subject to periodic consent of the Northern Ireland Legislative Assembly, the initial period of application extending to 4 years after the end of the transition period. (91)

The IE/NI Protocol makes certain provisions of EU law applicable also to and in the United Kingdom in respect of Northern Ireland.
The IE/NI Protocol provides that all Union harmonisation legislation covered by this Guide applies to and in the United Kingdom in respect of Northern Ireland. (92)

This means that, insofar as EU law made applicable by the IE/NI Protocol to the United Kingdom in respect of Northern Ireland is concerned, references to the EU have to be understood as including Northern Ireland, whereas references to the United Kingdom have to be understood as referring only to Great Britain (93).
More specifically, this means inter alia the following:






—


Products placed on the market in Northern Ireland have to comply with the applicable Union harmonisation legislation;










—


A product manufactured in Northern Ireland and shipped to the EU is not an imported product for the purpose of labelling and identification of economic operators / responsible persons;










—


A product shipped from Great Britain to Northern Ireland is an imported product;










—


Importers, authorised representatives and other economic operators required to be established in the Union may be established in Northern Ireland.










—


Certificates issued by a Notified Body in Great Britain are not valid in Northern Ireland. A Notified Body in Northern Ireland, however, can continue to certify products in certain circumstances (see below).




However, the IE/NI Protocol excludes the possibility for the United Kingdom in respect of Northern Ireland to:






—


participate in the decision-making and decision-shaping of the Union; (94)











—


initiate objections, safeguard or arbitration procedures to the extent that they concern regulations, standards, assessments, registrations, certificates, approvals and authorisations issued or carried out by EU Member States; (95)











—


act as leading authority for assessments, examinations and authorisations; (96)











—


invoke the country of origin principle or mutual recognition for products placed legally on the market in Northern Ireland; or for certificates issued by bodies established in the United Kingdom (97).




More specifically, this last point means inter alia the following:






—


Bodies established in Northern Ireland may certify products, but certificates issued by Notified Bodies in Northern Ireland are valid only in Northern Ireland. By contrast, these certificates are not valid in the EU (98).










—


Where a product is certified by a Notified Body in Northern Ireland, the indication ‘UK(NI)’ must be affixed next to the CE marking or any other applicable conformity marking. (99) This distinct marking allows the identification of products which can be legally placed on the market in Northern Ireland, but not in the EU.










—


In the non-harmonised area or for non-harmonised aspects, the principle of mutual recognition in one Member State of goods lawfully marketed in another Member State pursuant to Articles 34 and 36 of the Treaty on the Functioning of the European Union will not apply in respect of goods lawfully marketed in Northern Ireland. This means that the lawful placing of a product on the market of Northern Ireland cannot be invoked when that product is placed on the market in the EU. However, the lawful marketing of a product in a Member State can be invoked when that product is placed on the market in Northern Ireland.




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







In the case of new or revised legislation, economic operators may be given additional time to adapt to the new rules which is called transitional period and correspond to the lapse of time between the entry into force of a new rule and the moment it starts applying.





Transitional period means that the existing product rules remain applicable although new rules have been already adopted. Transitional period may be introduced by the legislator when EU product rules are being revised or come to replace national rules.
The aim of the transitional period is to allow manufacturers, national authorities and notified bodies to adjust gradually to the conformity assessment procedures and the essential or other legal requirements set up by a new or a revised piece of legislation, and, thus, to avert the risk of blocking production. Further, manufacturers, importers and distributors need to be given time to exercise any rights they have acquired under any pre-existing, national or EU rules, for example to sell their stocks of products manufactured in line with the pre-existing rules. Finally, the transitional period provides for extra time for the revision and adoption of harmonised standards, even though this is not a precondition for the application of Union harmonisation legislation.
Each Union harmonisation legislation providing for a transitional period sets the date for freezing the system in force. Generally, this is the date on which the legislation enters into force, but sometimes it is the date on which the legislation is adopted.
After the transitional period, products manufactured before or during this period, in line with the legislation to be repealed, may no longer be placed on the market. A product, which is placed on the market before the end of the transitional period, should be allowed to be made available on the market or put into service. (100) Nevertheless, specific Union harmonisation legislation could forbid the making available of such products if this is deemed necessary for safety reasons or other objectives of the legislation.
Products which were not placed on the market before the end of the transposition period can only be placed on the market or put into service, if they fully comply with the provisions of the new legislation (101).
According to the general rule, CE marking is an indication that products, which are subject to one or several pieces of Union harmonisation legislation providing for its affixing, conform to the provisions of all these applicable legislations. However, where one or more of these pieces of legislation allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking is an indication of conformity only to the legal texts applied by the manufacturer. Consequently, during a transitional period, the CE marking does not necessarily indicate that the product conforms to all applicable pieces of legislation providing for its affixing. Information concerning all Union harmonisation legislation applied by the manufacturer has to be found in the EU Declaration of Conformity (102).
2.11.   Transitional arrangements for the EU Declaration of Conformity

Union harmonisation legislation does not necessarily foresee a transitional solution for the information to be included in the EU Declaration of Conformity when existing legislation is replaced by a new one. This is the case for the Directives which have been revised to be aligned to the reference provisions of Decision No 768/2008/EC (103). The essential requirements in most of these Directives are not modified and there is no transitional period for referring to the old or new Directives. Furthermore, where relevant, aligned Directives specify that certificates issued under the old Directive remain valid under the new Directive. In such cases, products would meet both the requirements of the old and of the new legislation. As of their entry into force, the EU Declaration of conformity will need to include the reference to the new Directives for the products placed on the market to be considered as compliant.
Union harmonisation legislation in most cases only specifies the mandatory minimum content of the EU Declaration of Conformity but additional useful information is generally accepted. Manufacturers may make use of this flexibility and start using the new model structure set out in the Annexes of the aligned directives ahead of their entry into application. Where products comply with the requirements of both the old and new Directives, economic operators could refer to the two Directives in the EU Declaration of Conformity (‘old’ and aligned Directives), indicating the corresponding periods of application for each of the directives. For example, for a product in the scope of Directive 2014/30/EU, the EU Declaration of Conformity could contain the following statement:
‘The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: Directive 2004/108/EC (until 19 April 2016) and Directive 2014/30/EU (from 20 April 2016).’
2.12.   Summary examples

The examples listed below are completely hypothetical and only meant to illustrate different issues explained in the sections above






1.


An X-ray machine manufactured in the USA that has been sold to a hospital in the Netherlands on 15 March 2019 but will only arrive at Dutch customs on 5 April 2019. The product is sold by the manufacturer outside the EU directly to the EU customer via distance sales.
In this case, the date of placing on the market of the X-ray machine is 15 March 2019. This is the date in which a product already manufactured was bought from a manufacturer outside the EU by an EU end user, the order was placed and accepted of a product ready to be shipped. (See Section 2.4. Making available and placing on the market in case of distance and online sales)










2.


A printer manufactured in China is sent to the EU to a Spanish importer on 15 February 2019 for further distribution in the Union and released for free circulation in the EU on 15 March 2019. The product is manufactured outside the EU and placed on the Union market by an importer. In this case, the date of placing on the market is 15 March 2019 which is the date of release for free circulation. (See Section 2.5. Products imported from countries outside the EU)










3.


A toy manufactured in the EU and sent to the distribution branch of the manufacturer on 20 October 2019. The product is manufactured in the Union and placed on the market by the EU manufacturer. Even if the distributor belongs to the manufacturer, the date of placing on the market is 20 October 2019, which is the date the product is first supplied for distribution on the Union market. (See Section 2.3. Placing on the market)










4.


A taximeter manufactured in the EU, sold to a distributor on 10 January 2019. New legislative requirements are applicable as of 1 March 2019. It is installed in a taxi on 20 March 2019. In this example, the date of placing on the market is, following the same reasoning as in the example above, 10 January 2019. It can still be put into service despite new requirements entering into force on 1 March 2019 (unless otherwise provided for in the new Union harmonisation legislation). (See Section 2.6. Putting into service or use (and installation)).










5.


A completed machine is ordered by an EU end-user on 1 April 2019 on the basis of an offer/model in a catalogue. The machine is subsequently manufactured in China and shipped to the end user on 1 June 2019. It arrives at customs on 20 June 2019. The product is sold by the manufacturer outside the EU directly to the EU customer via distance sales. In this example, the date of placing on the market is 1 June 2019. This is the date in which the product bought from a manufacturer outside the EU by an EU end user is already manufactured and ready to be shipped. (See Section 2.4. Making available and placing on the market in case of distance and online sales)










6.


A manufacturer of personal computers in the EU supplies a number of its own PC production for the use of its employees on 1 February 2019. Those products are supplied for use on the Union market and thus placed on the market on 1 February 2019. (See Section 2.3. Placing on the market)










7.


A manufacturer of toys outside the EU sends 100 toys of the same model to a fulfilment service provider on 15 March 2019 and they are released for free circulation on 20 March 2019. The manufacturer starts selling those products on its website as of 1 April 2019. The products are manufactured outside the EU and physically transferred to a fulfilment service provider for distribution on the Union market. In this example, the date of placing on the market is 20 March 2019, which is the date of the release for free circulation. (See Section 2.4. Making available and placing on the market in case of distance and online sales)




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

Union harmonisation legislation defines the manufacturer, the authorised representative, the importer and the distributor as ‘economic operators’ (104). In addition, Regulation (EU) 2019/1020 also includes in this category the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation.
3.1.   Manufacturer












—



The manufacturer is any natural or legal person who manufactures a product or has a product designed or manufactured, and places it on the market under his own name or trademark.











—



The manufacturer is responsible for the conformity assessment of the product and is subject to a series of obligations including traceability requirements.











—



When placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.











—



The manufacturer must cooperate with the competent national authorities in charge of market surveillance in case of a product presenting a risk or being non-compliant.









The manufacturer is any natural or legal person who is responsible for designing or manufacturing a product and places it on the market under his own name or trademark (105). The definition contains two cumulative conditions: the person has to manufacture (or have a product manufactured) and to market the product under his own name or trademark. So, if the product is marketed under another person’s name or trademark, this person will be considered as the manufacturer.
The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes or labels ready-made products and places them on the market under his own name or trademark. Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential or other legal requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the market or for putting it into service, in those cases where the Union harmonisation legislation applicable to the product includes putting into service in its scope (106).
The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed or labelled with a view to placing it on the market under his own name or trademark, and thus presenting himself as a manufacturer (107). Where subcontracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfil his responsibilities according to the relevant Union harmonisation act. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorised representative, a distributor, a user or a subcontractor.
The manufacturer has ultimate responsibility for the conformity of the product to the applicable Union harmonisation legislation, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market under his name or trademark.
Thus, when a product is transferred to a manufacturer for further measures such as assembling, packaging, processing or labelling, when placing the product on the market, he has the sole and ultimate responsibility for ensuring the conformity of the product to the applicable legislation, and must be able to do so.
The manufacturer is responsible for designing and manufacturing the product in accordance with essential or other legal requirements laid down by the relevant Union harmonisation legislation and for carrying out conformity assessment in accordance with the procedure(s) laid down by the Union harmonisation legislation (108).
The manufacturer is obliged to understand both the design and construction of the product to be able to take the responsibility for the product being in compliance with all provisions of the relevant Union harmonisation legislation. This applies equally to situations where the manufacturer designs, manufactures, packs and labels the product himself, as to situations where some or all of these operations are carried out by a subcontractor. The manufacturer needs to have the relevant information to demonstrate compliance of the product at its disposal.
In this respect, the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonisation legislation. Therefore he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore he must be in the possession of all documentation (such as the technical documentation including any relevant test reports) and certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name. In such cases, it must be clear that the documentation and certificates demonstrate compliance of the specific product placed on the market.
The Lifts Directive 2014/33/EU defines the installer of a lift as ‘the natural or legal person who takes responsibility for the design, manufacture, installation and placing on the market of the lift’. Hence, the installer is a person who assumes responsibilities which in the context of other Union harmonisation legislation are typically assigned to the manufacturer.
Union harmonisation legislation does not require the manufacturer to be established in the European Union. Thus, when placing a product on the Union market, the responsibilities of a manufacturer are the same whether he is established outside the European Union or in a Member State.
As a general rule, when placing a product on the market the manufacturer must take all measures necessary to ensure that the manufacturing process assures compliance of the products (109) and in particular:






1.


carry out the applicable conformity assessment or have it carried out, in accordance with the procedure(s) laid down by the relevant Union harmonisation legislation. Depending on the Union harmonisation act, the manufacturer may be required to submit the product to a third party (usually a notified body) to have the conformity assessment carried out, or to have a quality system approved by a notified body. In any case, the manufacturer bears full responsibility for product conformity;










2.


draw up the required technical documentation;










3.


draw up the EU Declaration of Conformity;










4.


accompany the product with instructions and safety information (110) (111) as required by the applicable Union harmonisation legislation (112), in a language easily understood by consumers and other end-users, as determined by the Member State concerned (113). Unless otherwise specified in specific legislation, instructions and safety information need to be provided (114), whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. 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. Furthermore, a tool designed and intended to be used by professionals only might also be used by non-professionals, the design and instructions accompanied must take this possibility into account. Instructions and safety information must be clear, understandable and intelligible;










5.


satisfy the following traceability requirements:






—


Keep the technical documentation and the EU Declaration of Conformity for 10 years after the product has been placed on the market (115) or for the period specified in the relevant Union harmonisation act.










—


Ensure that the product bears a type, batch or serial number or other element allowing its identification.










—


Indicate the following elements: his (1) name, registered trade name or registered trade mark and (2) a single contact postal address on the product (116) or when not possible because of the size or physical characteristics of the products (117), on its packaging (118) and/or on the accompanying documentation (119) (120) (121). The single contact point may not necessarily be located in the Member State where the product is made available on the market.














6.


affix the conformity marking (CE marking and where relevant other markings (122)) to the product in accordance with the applicable legislation;










7.


ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of a product is declared must be adequately taken into account. The kind of action to be taken by the manufacturer depends on the nature of changes in the harmonised standards or other technical specifications, in particular whether these changes are material with regard to the coverage of the essential or other legal requirements and whether they concern the product in question. This might require for instance to update the EU Declaration of Conformity, change the product design, contact the notified body, (123) etc.;










8.


where relevant, certify the product and/or the quality system.




Under certain Union harmonisation acts, the manufacturer may be required to perform sample testing at the end of the production chain or of already marketed products in view of offering additional protection to consumers or other end-users (124) (125).
Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Union harmonisation legislation must immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where manufacturers have reason to believe that the product presents a risk to health, safety, the environment or any other public interest protected by the applicable legislation (126), they must immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the noncompliance and of any corrective measures taken. The Commission provides an IT tool, the Product Safety Business Alert Gateway’ to facilitate practical aspects of this obligation (127).
Upon a reasoned request (128), the manufacturer has to provide the competent national authority with all the information and documentation necessary to demonstrate the conformity of a product, in a language which can be easily understood by that authority. This would include, for example, the declaration of conformity, the relevant part of the technical documentation, or certificates issued by Notified Bodies. If agreed with market surveillance authorities, this information may be transmitted electronically. Manufacturers must cooperate with the authority, at its request, on any action taken to eliminate or mitigate the risks posed by products which they have placed on the market. Manufacturers must on request of market surveillance authorities identify any economic operator to whom they have supplied a product. They must be able to present this information for a period of 10 years after they have supplied the product.
The idea is that the national authority might accept a language they understand and which is different from the national language(s). The language chosen is subject to negotiation with the authority and could be a third language, if accepted by the authority.
In the case of a reasoned request it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation. The request may indicate a deadline for the receipt of the requested documents, depending on the Union harmonisation legislation the product is subject to. A shorter deadline can be fixed if the national authority justifies the urgency on the basis of an immediate serious risk.
If the Union harmonisation legislation covers putting into service, the natural or legal person who puts the product into service has the same responsibilities as a manufacturer who places a product on the market. He must ensure that the product complies with the Union harmonisation legislation, and that the appropriate conformity assessment procedure has been carried out (129).
Furthermore, a person who places on the Union market second-hand products from a third country, or any product not designed or manufactured for the Union market, must assume the role of the manufacturer.
Finally, if an importer or distributor modifies a product to the extent that the compliance with the applicable requirements may be affected or supplies it under his name or trademark, then he is to be considered the manufacturer and must undertake all the obligations incumbent on the manufacturer (130). Accordingly, he must ensure that the product complies with the applicable Union harmonisation legislation and that the appropriate conformity assessment procedure has been carried out (131).
3.2.   Authorised representative







Irrespectively of whether he is established in the EU or not, the manufacturer may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks.





Whether the manufacturer is established in the EU or not, he may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks required in the applicable Union harmonisation legislation (132). A manufacturer established outside the European Union is not obliged to have an authorised representative (133).
For the purposes of Union harmonisation legislation, to be able to act on behalf of the manufacturer, the authorised representative must be established inside the Union. Commercial representatives of the manufacturer (such as authorised distributors or agents), are not to be confused with the authorised representative in the meaning of Union harmonisation legislation.
The delegation of tasks from the manufacturer to the authorised representative must be explicit and set out in writing, in particular to define the contents and limits of the representative’s tasks. The tasks that may be delegated to the authorised representative according to the Union harmonisation legislation are of an administrative nature. Thus, the manufacturer may neither delegate the measures necessary to ensure that the manufacturing process assures compliance of the products nor the drawing up of technical documentation, unless otherwise provided for. Further, an authorised representative cannot modify the product on his own initiative in order to bring it into line with the applicable Union harmonisation legislation.
Where the manufacturer appoints an authorised representative, the mandate shall at least allow the authorised representative to perform the following tasks:






—


keep the EU declaration of conformity and the technical documentation at the disposal of national surveillance authorities and cooperate with them at their request,










—


upon a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product,










—


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




Depending on the conformity assessment procedure or the Union harmonisation act in question, the authorised representative can also, for instance, be appointed to perform tasks, specified in the written mandate, such as:






—


affix the CE marking (and where relevant other markings) and the notified body’s number to the product,










—


draw up and sign the EU Declaration of Conformity,










—


act as the economic operator referred to in Article 4 of Regulation (EU) 2019/1020 to perform the tasks set out in paragraph (3) of that article.




The authorised representative who is appointed by a manufacturer may be an importer or a distributor in the meaning of Union harmonisation legislation, in which case he must also to fulfil the obligations of the importer or distributor (134).
3.3.   Importer












—



The importer is a natural or legal person established in the Union who places a product from a third country on the EU market.











—



His obligations build on the obligations of the manufacturer.









The importer is the economic operator established in the Union who places a product from a third country on the Union market. He has important and clearly defined responsibilities under Union harmonisation legislation (135) (136). To a large extent they build on the type of responsibilities which a manufacturer based in the EU is subjected to.
The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of products, but has a key role to play in guaranteeing the compliance of imported products.
The importer is defined as any natural or legal person who places a product from a third country on the EU market. As a general rule, before placing a product on the market the importer must ensure:






1.


that the appropriate conformity assessment procedure has been carried out by the manufacturer. If he has any doubt about the conformity of the product, he must refrain from placing it on the market. If the product has already been placed on the market, he has to take corrective actions. (137) In both cases the manufacturer might need to be contacted to clarify any doubt about the conformity of the product.










2.


that the manufacturer has drawn up the technical documentation, affixed the relevant conformity marking (e.g. CE marking), fulfilled his traceability obligations and accompanied, where relevant, the product by the instructions and safety information in a language easily understood by consumers and other end-users, as determined by the Member State concerned. (138)





These obligations are meant to make sure that the importers are aware of their responsibility to place only compliant products on the market (139). Neither do they imply the need for importers to systematically resort to additional control procedures or (third- party) testing, nor do they preclude them from doing so.
The importer also has to:






—


Indicate the following two elements: his (1) name, registered trade name or trade mark and (2) the address at which he can be contacted on the product or where not possible because of the size or physical characteristics of the product or because the packaging would need to be opened, on the packaging or/and (140) on the accompanying documentation (141). By doing so, he must not impede the visibility of any safety information printed on the product or the accompanying documents.










—


Ensure that, while a product is under his responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in the applicable legislation.










—


Keep a copy of the EU Declaration of Conformity for 10 years after the product has been placed on the market (142) or for the period specified in the relevant Union harmonisation act.










—


Ensure that the technical documentation can be made available to the competent national authority upon request (143). The importer has to cooperate with that authority and upon a reasoned request (144), has to provide that authority with all the information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority. The idea is that the national authority might accept a language they understand and which is different from the national language(s). The language chosen is subject to negotiation with the authority and could be a third language, if accepted by the authority.










—


In the case of a reasoned request it is sufficient for the importer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation.










—


On request by market surveillance authorities, the importer must identify any economic operator who has supplied him and to whom he has supplied the product. He must be able to present this information for a period of 10 years after he has been supplied with the product and for a period of 10 years after he has supplied the product.




Further, under certain Union harmonisation acts, the importer, like a manufacturer, may be required to perform or have performed sample testing of products already placed on the market (145).
Equally, importers who have reason to believe that a product which they have placed on the market is not in conformity with the Union harmonisation legislation applicable, shall immediately take the corrective measures necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, importers shall immediately inform the competent national authorities.
The importer needs neither a mandate from the manufacturer, nor a preferential relationship with the manufacturer like the authorised representative. However, the importer must ensure, in order to fulfil his responsibilities, that a contact with the manufacturer can be established (e.g. to make the technical documentation available to the requesting authority).
The importer may wish to carry out administrative tasks on behalf of the manufacturer. In such a case, he has to be explicitly designated by the manufacturer in order to become an authorised representative.
3.4.   Distributor












—



The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.











—



Distributors are subject to specific obligations and have a key role to play in the context of market surveillance.









Along with manufacturers and importers, distributors are the third category of economic operators who are subject to specific obligations. The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.
Distributor must act with due care (146) in relation to the applicable requirements (147). They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU Declaration of Conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors.
Conformity assessment, drawing up and keeping the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or the importer for keeping the declaration of conformity in the case of products from third countries. It is not part of the distributor’s obligations to check whether a product already placed on the market is still in conformity with the legal obligations that are currently applicable in case these have changed. The obligations of the distributor refer to the legislation applicable when the product was placed on the market by the manufacturer or the importer unless specific legislation provides otherwise.
The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU Declaration of Conformity and the necessary parts of the technical documentation. Market surveillance authorities have the possibility to address their request for the technical documentation directly to the distributor. The latter is however not expected to be in possession of the relevant documentation.
Before making a product available on the market, the distributor must verify the following formal requirements (148):






—


that the product bears the required conformity marking(s) (e.g. CE marking);










—


that the product is accompanied by the relevant documents (e.g. EU Declaration of Conformity (149)) and by instructions and safety information (150) in a language which can be easily understood by consumers and other end-users if required by the applicable legislation;










—


that the manufacturer and importer have indicated their (1) name, registered trade name or trademark and (2) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation (151), and that the product bears a type, batch or serial number or other element allowing the identification of the product.




Distributors must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation. Further, they must cooperate with the competent authority in actions taken to avoid or minimise these risks, inform the manufacturer or the importer as well as the competent national authorities (152).
Similar obligations bind distributors once a product is made available. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures to bring the product into conformity are taken by the manufacturer or the importer and inform the competent national authorities. Distributors have to contact the importer or manufacturer to clarify any doubt about the conformity of the product.
In addition to controlling the conformity of the product with the formal requirements, the distributor must:






1.


initiate corrective measures where there is suspicion of a non-conformity (153);










2.


assist market surveillance authorities in identifying the manufacturer or importer responsible for the product;










3.


upon a reasoned request (154) from a competent authority, cooperate with that authority and provide it with all the information and documentation necessary to demonstrate the conformity of a product (155);










4.


on request by market surveillance authorities, identify any economic operator who has supplied them and to whom they have supplied the product. They must be able to present this information for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product (156).




The distribution conditions (for example transport or storage) may have an impact on maintaining the compliance with the provisions of the applicable Union harmonisation legislation. Thus, the person in charge of the distribution conditions must take the necessary measures to protect the compliance of the product. This is to ensure that the product complies with the essential or other legal requirements at the moment of first use within the Union (157).
The distribution conditions may, in the absence of Union harmonisation legislation, be regulated to some extent on the national level in accordance with Articles 34 and 36 TFEU. National legislation that grants to members of a specific profession the exclusive right to distribute certain products is capable, insofar as it restricts sales to certain channels, of affecting the possibilities of marketing imported products. Accordingly, such legislation may constitute a measure having an effect equivalent to a quantitative restriction on imports. However, it can be justified for instance on grounds of the protection of public health, if the measure is appropriate for the purpose and does not go beyond what is necessary to achieve it (158).
3.5.   Fulfilment Service Providers

Regulation (EU) 2019/1020 includes fulfilment service providers as another category of economic operators. Fulfilment service providers are any natural or legal person offering, in the course of a commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved. The qualifying services do not include postal services (159), parcel delivery services (160) and any other postal or freight transport services. (161) Fulfilment service providers located in the EU are generally used to warehouse products offered by online operators to guarantee their swift delivery to EU consumers. These entities provide services to other economic operators. They store products and, further to the receipt of orders, they package the products and ship (dispatch) them to customers. Sometimes, they also deal with returns. There is a wide range of operating scenarios for delivering fulfilment services. Some offer all of the services listed above, while others only cover them partially. Their size and scale also differ, from global operators to micro businesses. The activities of fulfilment service providers go beyond those of parcel service providers that provide clearance services, sorting, transport and delivery of parcels.
Fulfilment service providers are considered as economic operators under Regulation (EU) 2019/1020 and have to cooperate with market surveillance authorities in relation to the products they handle (162). Where the product falls within the scope of Article 4 of Regulation (EU) 2019/1020, the fulfilment service provider established in the Union becomes the economic operator under that Article 4 with respect to the products it handles, where there is no manufacturer, importer or authorised representative established in the Union and responsible for those products pursuant to Article 4 (1) of Regulation (EU) 2019/1020.
Taking into account the variety of fulfilment service providers and the services they provide, the analysis of the economic model of some operators and the extent of their activities may conclude that they are also distributors, importers or authorised representatives.
3.6.   The economic operator referred to in Article 4 of Regulation (EU) 2019/1020 (163)

Article 4 of Regulation (EU) 2019/1020 requires in essence that for certain products placed on the EU market there must be an economic operator in the EU who on request provides the authorities with information or takes certain action. This applies from 16 July 2021.
An economic operator referred to in Article 4 is required when a product falls within the scope of one or more Directives or Regulations listed in paragraph 5 of Article 4 of Regulation (EU) 2019/1020 or other legislation that makes explicit reference to Article 4 (164), in order to place the product on the Union market.
Four types of economic operator can act as the economic operator referred to in Article 4: i) a manufacturer established in the Union; ii) an importer (by definition established in the Union), where the manufacturer is not established in the Union; iii) an authorised representative (by definition established in the Union) who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in Article 4(3) on behalf of the manufacturer; or iv) a fulfilment service provider established in the Union where there is no manufacturer, importer or authorised representative established in the Union.
The (1) name, registered trade name or registered trademark, and (2) contact details, including the postal address, of the economic operator referred to in Article 4 have to be indicated on the product or on its packaging, the parcel or an accompanying document (165). In case the economic operator referred to in Article 4 is an EU manufacturer or an importer, this information is normally already required under Union harmonisation legislation (see Sections 3.1 and 3.3) within the scope of Article 4 (166).
The name and contact details of the economic operator referred to in Article 4 have to be present when the product is declared for free circulation at customs (as confirmed by Article 26(1)(d) of Regulation (EU) 2019/1020). Therefore, in case the product is aimed for release for free circulation in the EU and no further processing on the product is foreseen after its shipment (167), economic operators outside the EU offering products for sale should make sure that the required information on the economic operator referred to in Article 4 is indicated in the way described above, adding them (or having them added) prior to shipping if necessary. It is possible that there are multiple economic operators’ names and contact details indicated on or with the product. While there may be no explicit requirement that these be preceded by ‘manufactured by’, ‘imported by’, ‘represented by’ or ‘fulfilled by’, the information should not mislead the market surveillance authorities.
The economic operator referred to in Article 4 has a number of tasks which may already be fully or partly covered by their obligations under Union harmonisation legislation depending on the type of economic operator they are.
First, the economic operator referred to in Article 4 has to perform a number of tasks when it takes up its duties or when a new product is added to its portfolio:






—


Verify that the declaration of conformity has been drawn up and keep it for 10 years after the product has been placed on the market (168) or for the period specified in the relevant Union harmonisation act;










—


Verify that the technical documentation has been drawn up and ensure that it can be made available to market surveillance authorities on request – where the economic operator referred to in Article 4 does not keep the documentation itself, this implies checking that the documentation exists and obtaining assurances from the manufacturer that it will share it on request, either with the economic operator referred to in Article 4 or with the market surveillance authorities directly.




Second, where the economic operator referred to in Article 4 has reason to believe that a product presents a risk, it must:






—


Inform the relevant market surveillance authorities. It should do this in each Member State in which the product was made available; it is important also to inform them of the corrective action that has been or will be taken; and










—


Make sure that the necessary corrective action is taken immediately to remedy any case of non-compliance or, if that is not possible, to mitigate the risk.










—


Finally, the economic operator referred to in Article 4 must take certain actions when asked to do so by the market surveillance authorities:






—


provide that authority with the EU declaration of conformity;










—


provide the authority with technical documentation, or where the economic operator referred to in Article 4 does not keep this documentation, ensure that the technical documentation is provided to the authority (in particular by the manufacturer);










—


provide other information and documentation to demonstrate the conformity of the product (this may include e.g. certificates and decisions from a notified body) in a language which can be easily understood by that authority (to be negotiated with the authority – this could be a language other than the national language(s)).










—


cooperate with the authority. The action required will depend on the authority’s request, which has to be in accordance with the principle of proportionality; and










—


make sure that the necessary corrective action is taken to remedy any non-compliance with the Union harmonisation legislation applicable to the product in question or, if that is not possible, to mitigate the risks presented by that product.










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The action could involve bringing the product into conformity, withdrawing it or recalling it, as appropriate (169). The economic operator referred to in Article 4 does not have to take corrective action or mitigate the risk itself if that economic operator is not obliged to do so under the sector-specific legislation, but must ensure that action is taken, e.g. by asking the manufacturer to respond to the request and verifying that it has done so.








The manufacturer remains responsible for the compliance of the product with Union harmonisation legislation and (like other actors in the supply chain) retains any legal obligations it has as regards products, guarantees, liability for defective products, etc. Article 4 does not impose additional legal obligations vis-à-vis consumers or other end-users.
3.7.   Other intermediaries: Intermediary service providers under the E-Commerce Directive

The E-Commerce Directive (170) establishes the legal framework for electronic commerce in the EU. It introduces harmonised rules on issues such as the transparency and information requirements for online services providers, commercial communications or electronic contracts.
The E-commerce Directive does not cover categories of economic operators, but rather describes different categories of activities. The most relevant categories of activities, from a product safety and compliance point of view, are the hosting activities (171). Hosting activities are activities such as storing information provided by the recipient of the service, e.g. web shops and online market places or platforms.
Intermediary service providers carrying out the activities described above benefit from an exemption of liability for damages or criminal sanctions related to the content provided by third parties using their networks. However, the liability exemption is not absolute. In the case of hosting activities, which are the most relevant for the product safety and compliance area, the exemption only applies if the intermediary service provider (1) has no actual knowledge or awareness about the illegal nature of the information hosted and (2) upon obtaining such knowledge or awareness of the illegal content (for instance by a ‘sufficiently precise and adequately substantiated’ notice (172)), it acts expeditiously to remove it or disable access. If they do not fulfil these conditions, they cannot be covered by the exemption and thus they can be held liable for the content they host.
Following Article 15 of the E-commerce Directive, Member States cannot impose either a general obligation on these providers to monitor the content or a general obligation to actively seek facts or circumstances indicating illegal activity. This means that national authorities cannot establish a general obligation for intermediaries to actively monitor their entire Internet traffic and seek elements indicating illegal activities such as unsafe products.
The ban on requesting general monitoring, however, does not limit public authorities in establishing specific monitoring requirements, although the scope of such arrangements have to be targeted.
In practice, this means that national authorities can contact the hosting providers who, when notified of unlawful activity, if they want to benefit from the exemption of liability, have to remove or disable the content, meaning that the unsafe/non-compliant products would no longer be accessible to EU customers through their services.
Regulation (EU) 2019/1020 explicitly addresses information society service providers. Information society service providers are required to cooperate with the market surveillance authorities at the request of the market surveillance authority and, in specific cases, to facilitate any action taken to eliminate or, if that is not possible, to mitigate the risks presented by a product that is or was offered for sale online through their services (Article 7). In particular, market surveillance authorities have the power, where no other effective means are available to eliminate a serious risk posed by a product, to require the removal of content referring to the related products from an online interface or to require the explicit display of a warning to end users when they access an online interface (Article 14 (4)(k)(i)). Where such a request has not been complied with, market surveillance authorities have the power to require information society service providers to restrict access to the online interface, including by requesting a relevant third party to implement such measures (Article 14 (4)(k)(ii)). Market surveillance authorities should assess the most appropriate action to be taken on a case-by-case basis and with a view to the principle of the proportionality, taking into account the level of the risk, if the economic operator is identifiable, the urgency, if previously measures have been taken against given product etc. (173).
3.8.   End-user












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The end user is any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities.











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Many products covered by Union product harmonisation legislation are used at work and thus also subject to Union safety at work legislation.









The end user is any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities (174). Union harmonisation legislation does not create obligations for the end-users of the products in their scope (175). This is the case even when there are no responsible economic operators present within the EU (for example, in the context of products sold online and for which an economic operator under Article 4 of Regulation (EU) 2019/1020 is not required. (176). The term thus covers both professional users and consumers. The concept of ‘end use’ by a professional or a consumer is intrinsically related to the concept of ‘intended use’ (177).
Many products covered by Union harmonisation legislation are used at work. According to legislation based on Article 153 TFEU, employers have obligations as regards the use of work equipment by workers at the workplace. An employer is considered to be any natural or legal person who has an employment relationship with a worker (that is any person employed by an employer), and has responsibility for the undertaking or establishment.
According to the Directive concerning the minimum safety and health requirements for the use of work equipment by workers at work (2009/104/EC), the employer must take all measures necessary to ensure that the work equipment (for example machinery and apparatus) made available to the workers is suitable for the work carried out, and may be used by workers without impairment to their safety or health. The employer may only obtain or use work equipment that complies with the provisions of the applicable legislation at the time of its first use, or, if no other legislation is applicable or is only partially applicable, the minimum requirements laid down in Annex I to Directive 2009/104/EC. The employer must also take the necessary measures to ensure that work equipment is kept at such a level. Further, the employer has an obligation to provide information and training for workers as regards the use of work equipment.
According to the Directive concerning the minimum health and safety requirements for the use of personal protective equipment by workers at the workplace (89/656/EEC), such equipment must comply with the relevant Union provisions on design and manufacture with respect to safety and health (that is the Union harmonisation act relating to personal protective equipment). Further, the equipment must be appropriate for the risk involved, correspond to existing conditions at the workplace, take into account ergonomic requirements and the worker’s state of health, fit the wearer correctly, and be compatible where more than one pieces of equipment must be used simultaneously. The employer is required, before choosing the personal protective equipment, to assess that it satisfies the requirements.
According to the Directive on the minimum safety and health requirements for work with display screen equipment (90/270/EEC), employers are obliged to perform an analysis of workstations in order to evaluate the safety and health conditions, particularly regarding possible risks to eyesight, physical problems and problems of mental stress. The Directive also lays down the minimum requirements for the display screen and other equipment.
According to the Directive on the introduction of measures to encourage improvements in the safety and health of workers at work (89/391/EEC), workers have a general responsibility to take care, as far as possible, of their own safety and health and that of other persons affected by their acts at work. In accordance with the training and the instructions given by their employer they must, for instance, make correct use of machinery, apparatus, and other means of production, and the personal protective equipment.
Directives 89/391/EEC, 2009/104/EC, 89/656/EEC and 90/270/EEC lay down minimum requirements. Therefore, Member States are allowed to adopt or retain more stringent provisions, as long as they are compatible with the TFEU. The provisions of Union harmonisation legislation must be respected and, thus, additional national provisions may neither request a modification of a product within the scope of a Union harmonisation act, nor influence the conditions of the making available on the market of such products.
4.   PRODUCT REQUIREMENTS

4.1.   Essential product requirements

4.1.1.   
Definition of essential requirements













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A large part of Union harmonisation legislation limits legislative harmonisation to a number of essential requirements that are of public interest.











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Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so.









A fundamental feature of a large part of Union harmonisation legislation is to limit legislative harmonisation to the essential requirements that are of public interest. These requirements deal with the protection of health and safety of users (usually consumers and workers) but may also cover other fundamental requirements (for example protection of property, scarce resources or the environment).
Essential requirements are designed to provide and ensure a high level of protection. They either arise from certain hazards associated with the product (for example physical and mechanical resistance, flammability, chemical, electrical or biological properties, hygiene, radioactivity, accuracy), or refer to the product or its performance (for example provisions regarding materials, design, construction, manufacturing process, instructions drawn up by the manufacturer), or lay down the principal protection objective (for example by means of an illustrative list). Often they are a combination of these. As a result, several Union harmonisation acts may be applicable to a given product at the same time, since the essential requirements of different Union harmonisation acts need to be applied simultaneously in order to cover all relevant public interests.
Essential requirements must be applied as a function of the hazard inherent to a given product. Therefore, manufacturers have to carry out a risk analysis to first identify all possible risks that the product may pose and determine the essential requirements relevant for the product. This analysis implies that the manufacturer should assess all the different elements of the products and determine which Union harmonisation legislation applies to it, and which specific essential requirements as set out therein. This analysis has to be documented and included in the technical documentation (178). In addition, the manufacturer needs to document the assessment of how the risks identified are addressed to ensure that the product complies with the relevant essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all relevant essential requirements, then the way relevant essential requirements not covered by it are dealt with, should be documented (179).
Essential requirements define the results to be attained, or the hazards to be dealt with, but do not specify the technical solutions for doing so. The precise technical solution may be provided by a standard or by other technical specifications or be developed in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature at the discretion of the manufacturer. This flexibility allows manufacturers to choose the way to meet the requirements. It allows also that, for instance, the materials and product design may be adapted to technological progress. Accordingly, Union harmonisation legislation based on essential requirements does not necessitate regular adaptation to technical progress, since assessment of whether requirements have been met or not are based on the state of technical know-how at the moment the product is placed on the market.
The essential requirements are set out in relevant sections or annexes of a given piece of Union harmonisation legislation. Although no detailed manufacturing specifications are included in the essential requirements, the degree of detailed wording differs between different Union harmonisation acts (180). The wording is intended to be precise enough to create, on transposition into national legislation, legally binding obligations that can be enforced, and to facilitate the setting up of standardisation requests by the Commission to the European standardisation organisations (ESOs) in order to produce harmonised standards. They are also formulated so to enable the assessment of conformity with those requirements, even in the absence of harmonised standards or in case the manufacturer chooses not to apply them.
4.1.2.   
Conformity with the essential requirements: harmonised standards













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The terms ‘standard’, ‘national standard’, ‘European standard’, ‘harmonised standard’ and ‘international standard’ are subject to concrete definitions in Article 2 of Regulation (EU) No 1025/2012.











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Standards are technical specifications and are therefore useful and effective in promoting and disseminating good technical practises and technical solutions.











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Standards are in themselves of voluntary application.











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Harmonised standards are European standards adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.











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If references of harmonised standards have been published in the Official Journal of the European Union (OJEU), they provide a presumption of conformity with the essential or other legislative (181)
requirements they aim to cover.









4.1.2.1.   Definition of a harmonised standard

Regulation (EU) No 1025/2012 (182) provides definitions for the terms ‘standard’, ‘national standard’, ‘European standard’, ‘harmonised standard’ and ‘international standard’.






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‘Standards’ are defined as technical specifications (183), adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory and which are either international, European, harmonised or national standards.










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‘European standards’ are ‘standards’ adopted by the ESOs listed in Annex I of Regulation (EU) No 1025/2012 (184).










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‘Harmonised standards’ are ‘European standards’ adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.




The definition of a ‘harmonised standard’ within the context of Regulation (EU) No 1025/2012 is not restricted to harmonised standards supporting harmonised product legislation as the Regulation mainstreams the use of harmonised standards in harmonisation legislation for services in similar way as in Union harmonisation legislation for products.
4.1.2.2.   Role of harmonised standards

Harmonised standards are developed and adopted like other European standards following the internal rules of ESOs. According to these rules, all European standards must be transposed at national level by the national standardisation bodies. This transposition means that the European standards in question must be made available as national standards in an identical way, and that all conflicting national standards must be withdrawn in a given period.
Harmonised standards are European standards to which Regulation (EU) 1025/2012 and sectoral Union harmonisation legislation give a special meaning. However, it is important to note that the definition of a harmonised standard does not contain any reference to the publication of its reference in the OJEU. As long as a reference of a harmonised standard is not published in the OJEU the harmonised standard, or parts thereof, does not give presumption of conformity with the essential or other requirements it aims to cover. The ESOs are formally requested to draft harmonised standards via a standardisation request issued by the Commission. The role and preparation of the Commission’s standardisation request to the ESOs is detailed in the ‘Vademecum on European standardisation’ (185).
In order to provide presumption of conformity, a harmonised standard must match the relevant essential or other legal requirements of the relevant piece of legislation in line with the relevant standardisation request and be referenced in the OJEU. A harmonised standard may contain specifications relating not only to essential requirements but dealing with other non-regulated issues. In such a case, these specifications are to be clearly distinguished from those covering the essential requirements. A harmonised standard does not necessarily have to cover all essential requirements but it must be always clear which requirements are ‘aimed to be covered’ (186) as otherwise a manufacturer complying with a harmonised standard, referenced in the OJEU, does not know against which requirements a ‘presumption of conformity’ will apply and public authorities and notified bodies do not know against which essential requirements they must accept a presumption of conformity.
The relevant essential or other legal requirements aimed to be covered are usually indicated in a separate informative annex (187) to a harmonised standard. When essential requirements are covered only partially, it should be clearly indicated in the standard. In some cases the scope of a harmonised standard may also indicate the relevant requirements with sufficient clarity (e.g. when there is a clear reference to covered safety related risks). This information on the ‘aimed coverage of essential or other requirements’ given in a harmonised standard thereby determines the scope and the limits of the so-called ‘presumption of conformity with legal requirements’.
A clear distinction must be made between ‘conformity with a standard’ and ‘presumption of conformity (when applying (188) a harmonised standard)’. ‘Conformity with a standard’ usually makes a reference to a situation where a standard is ‘fully applied’. This is for instance the case of voluntary certification against a standard. For the purposes of ‘presumption of conformity’ it is sufficient to apply only those provisions relating to the essential or other legal requirements aimed to be covered.
Harmonised standards never replace legally binding essential requirements. A technical specification given in a harmonised standard is not an alternative to a relevant essential or other legal requirement but only a possible technical means to comply with it. In risk related harmonisation legislation this means in particular that manufacturers always, even when using harmonised standards the references of which are published in the OJEU, remain fully responsible for assessing all the risks of their product in order to determine which essential (or other) requirements are relevant. After this assessment a manufacturer may then choose to apply technical specifications given in harmonised standards the references of which are published in the OJEU to implement ‘risk reduction measures’ (189) which are specified by harmonised standards. In risk related harmonisation legislation harmonised standards the references of which are published in the OJEU most commonly provide certain means to reduce or remove risks while manufacturers remain fully responsible for risk assessment to identify relevant risks and to identify relevant essential requirements in order to select suitable harmonised standards the references of which are published in the OJEU or other specifications.

Flowchart 1


The role of harmonised standards in complying with relevant essential requirements identified by a manufacturer - a generic philosophy for cases where a manufacturer needs to identify relevant essential requirements






Where harmonised standards fail to indicate clearly the essential requirements aimed to be covered such standards may become less useful for manufacturers and market surveillance authorities as there is less legal certainty on the real ‘scope of presumption of conformity’. An unclear or incorrect indication of the essential requirements aimed to be covered may also lead, in some cases, to formal objections against harmonised standards (see point 4.1.2.5). Where a harmonised standard covers only part of the essential requirements identified as relevant by manufacturers or only certain aspects thereof, they additionally have to use other relevant technical specifications or develop solutions in accordance with general engineering or scientific knowledge laid down in engineering and scientific literature in order to meet the essential requirements of the legislation in question. In a similar way when manufacturers choose not to apply all the provisions given in a harmonised standard, and which normally would provide presumption of conformity, they need, on the basis of their own risk assessment, to indicate in their technical documentation how the compliance is reached or that relevant essential requirements are not relevant for the product.
Occasionally standards may contain errors or offer different possible readings. If manufacturers find such an error or uncertainty, they should first make contact with the national standardisation body to seek for clarification.
4.1.2.3.   The Presumption of conformity

Union harmonisation legislation may set out that Harmonised standards provide a presumption of conformity with the essential requirements they aim to cover, if their references have been published in the OJEU (190).
European standards, including harmonised standards, may be based fully or partially on international ISO or IEC standards. However, the presumption of conformity is possible only when applying the European version published by reference in the Official Journal, because of possible technical modifications introduced in it to ensure adequate compliance with the legal requirements. Additionally ISO and IEC versions do not contain information about which provision of the standard is relevant for which essential requirement, as this information is only included in their European version.
The objective of publishing the reference in the OJEU is to set the date from which the presumption of conformity takes effect. Publication of references of harmonised standards is managed by means of Commission Implementing Decisions. Publication in the OJEU is the ultimate goal for a harmonised standard and the end of the process which started when the relevant Commission standardisation request was issued.
Publication of references is not an automatic action and the Commission must perform certain checks and assessments before publication takes place. The Commission may thus refuse to publish the references or, where appropriate, may set certain restrictions which are published together with the references.
In a situation where a formal objection procedure has been already initiated prior to the publication of a reference in the OJEU, there is a doubt whether a harmonised standard entirely satisfies the requirements it aims to cover within the meaning of Article 11(1) of Regulation (EU) No 1025/2012. Because of this doubt, the Commission cannot publish the reference according to Article 10(6) of Regulation (EU) No 1025/2012 and a Commission Implementing Decision within the meaning of Article 11(1) must be taken.
The recourse to harmonised standards referenced in the OJEU and which give a presumption of conformity remains voluntary (191). Manufacturers can choose whether or not to apply such harmonised standards or parts thereof. However, if manufacturers choose not to apply a harmonised standard, they must demonstrate that the products are in conformity with essential requirements by the use of other means of their own choice (for example by means of any existing technical specifications including all other available standards). If the manufacturer applies only a part of a harmonised standard or the harmonised standard does not cover entirely all relevant essential requirements, the presumption of conformity exists only to the extent the harmonised standard corresponds to the essential requirements. For that reason it is necessary that each harmonised standard contains clear and correct information on legal (essential) requirements covered.
Compliance with harmonised standards is, according to certain Union harmonisation acts, an option having effect on the applicable conformity assessment procedure, and sometimes opens the possibility for conformity assessment without the intervention of a third party or for a larger choice of procedures (192).
4.1.2.4.   Withdrawal, restriction or prevention of the presumption of conformity

Article 11(1) of Regulation (EU) No 1025/2012 contains a provision for a formal objection procedure according to which the publication of references of harmonised standards in the OJEU can be challenged (193) by Member States and the European Parliament. This situation might arise prior to the publication of the reference of the harmonised standard in the OJEU or in the case of a harmonised standard the reference of which has already been published in the OJEU.
In both cases, where a Member State or the European Parliament (194) considers that a harmonised standard does not entirely satisfy the requirements which it aims to cover and which are set out in the relevant Union harmonisation legislation, it has to inform the Commission thereof. After consulting the Member States (195), the Commission will adopt a decision:






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to publish, not to publish or to publish with restrictions the reference to the harmonised standard concerned in the OJEU, or










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to maintain, to maintain with restrictions or to withdraw the references to the harmonised standard concerned in or from the OJEU.




Where a Member State has raised an action under a safeguard clause (196) against a product which complies with a harmonised standard and where such a safeguard action is considered justified, the Commission has a responsibility to initiate an objection against the relevant harmonised standard.
The procedure to challenge a harmonised standard and its outcome does not affect its existence as a harmonised standard or as a European standard as only the ESOs can make decisions on the revision or withdrawal of their deliverables. In addition to the controls available to the Commission, only this objection procedure gives the European Parliament and the Member States a possibility to control the presumption of conformity i.e. the legal effect, which stems from the publication of the reference in the OJEU. Provided the formal objection is justified, it may only lead to the withdrawal, restriction or prevention of such a publication in the OJEU. In the first two cases, this means that the harmonised standard in question will no longer give presumption of conformity or presumption of conformity with the essential requirements is restricted. In the last case (prevention) it means that the standard does not give presumption of conformity at all.
A harmonised standard can be challenged at any moment after its adoption by CEN, Cenelec or ETSI as a European standard.
Furthermore, the reference may be removed from the OJEU by the Commission, without applying formal objection procedures, in certain exceptional cases where the relevant edition of a harmonised standard is not anymore reviewed or updated by the ESO itself and where the ESO itself does not regard it as a standard. Such cases include situations where the harmonised standard in question has been withdrawn by the relevant ESO without any intention to adopt a revised harmonised standard. The concept of essential requirements is based on the assumption that the harmonised standards reflect generally acknowledgeable state of the art and the ESO review harmonised standards regularly in accordance with the relevant standardisation request. When it is evident that a harmonised standard is not anymore recognised as a standard by the relevant ESO itself or where the standard is not anymore revised or available as a national standard such a document cannot be, as a rule, used anymore to provide presumption of conformity. The purpose of Article 11 of Regulation (EU) No 1025/2012 is to provide a procedure to challenge only valid harmonised standards, not withdrawn harmonised standards or draft harmonised standards which cannot be regarded as adopted European standards in the context of definitions given in Article 2 of Regulation (EU) No 1025/2012.
Another specific situation where the Commission may need to remove references from the OJEU without formal objection relates to cases where publication in the OJEU is done by a mistake or where a reference of a document which cannot be regarded as a harmonised standard is published. The latter case may include cases where the standard is not covered by a standardisation request or where the standard does not cover any essential requirements or where the standard was not correctly adopted by respective ESO following the recognised standardisation principles.
According to Regulation (EU) No 1025/2012 the Commission is obliged to inform stakeholders (197) on all pending formal objections against harmonised standards before formal decisions are taken.
4.1.2.5.   Revision of harmonised standards

Harmonised standards translate the essential requirements or other legislative requirements into detailed technical specifications, methods of measurement to assess and/or declare the compliance with the essential requirements and, in some cases, numerical values to allow compliance with the essential requirements. Like any technical document, they are subject to change, or in other words to a revision.
The formal decision to revise a harmonised standard is taken by the ESOs. This takes place on the basis of their own initiative (198), or following a standardisation request from the Commission directly or, indirectly, based on a Commission decision after a formal objection. The need for revision can result from the changes of the scope of the Union harmonisation act (such as an extension of the scope to other products or a modification of the essential requirements), from the fact that the Commission or a Member State challenges the contents of the harmonised standard, indicating that it could no longer give presumption of conformity with the essential requirements, as a result of technological development or due to market demand.
When a harmonised standard is revised, the revision must be covered by a standardisation request to maintain the possibility of giving presumption of conformity. Unless the contrary can be deduced, the terms and conditions of the original standardisation request apply also for the revision of the harmonised standard. This does not exclude the possibility of a new or revised standardisation request, in particular where the revision is related to shortcomings with respect to the essential requirements.
To give presumption of conformity, the revised harmonised standard must satisfy the general conditions according to the Union harmonisation legislation: the harmonised standard is based on a standardisation request, it is presented by the relevant ESO to the Commission and its reference is published by the Commission in the OJEU.
It is under the exclusive competence of the Commission to decide on dates when the references of the superseded harmonised standards are withdrawn from the OJEU. In most common cases a withdrawal date set by the Commission and published in the OJEU allows for a ‘transitional or coexistence period’ during which both the withdrawn (superseded) harmonised standard and the revised (superseding) harmonised standard give a presumption of conformity simultaneously. The ‘transitional or coexistence period’ points to the time period between the date of publication of a reference of a revised harmonised standard in the OJEU and the date of withdrawal from the OJEU of the reference of the superseded harmonised standards.
It is the responsibility of the Commission to ensure that such transitional periods are of sufficient length but at the same time not disproportionately long. After a transitional period, only the revised (superseding) harmonised standard gives a presumption of conformity.
The Commission may consider that, for safety or other reasons, the superseded version of the harmonised standard must cease to give a presumption of conformity after a relatively short transitional period or even immediately. If circumstances allow, the Commission may consult the Member States and the ESOs prior to taking a decision to reduce the period during which both versions of the standard give a presumption of conformity. If necessary, the initially set transitional period might also be extended by the Commission.
Unless decided otherwise on the basis of a proposal by the Commission, the removal of the reference of a harmonised standard from the OJEU after its revision does not automatically invalidate existing certificates issued by notified bodies; it only concerns the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced according to the old certificate may still benefit from the continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies. However, manufacturers must keep themselves appraised of changes in the state of the art, assess the extent of the changes to the superseded version of the standard and, if necessary, take appropriate action. The kind of action to be taken by the manufacturer depends on the nature of the changes in the harmonised standards, in particular whether these changes are material with regard to the coverage of the essential requirements and whether they concern the product in question. In addition, the notified body shall also keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the relevant requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. The reference of the revised harmonised standard, together with the information concerning the superseded version of the harmonised standard, and the date when the presumption of conformity of the superseded version of the standard ceases are published in the OJEU. It is in the interest of manufacturers to check every publication of the list of harmonised standards in the OJEU and to verify within it the validity of the harmonised standards they have applied in order to assess the conformity of their product. This is particularly essential in cases where manufacturers declare conformity themselves (in case of internal production control) and where manufacturer want to ensure continuous presumption of conformity for the products placed on the market.
In the context of guidelines (199) agreed between the Commission and the ESOs there is an expectation that all revised harmonised standards should contain specific information indicating significant changes to a revised or amended harmonised standards and this information should be made publicly available (free of charge) by the ESOs.
4.1.3.   
Conformity with the essential requirements: other possibilities













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The conformity of a product with essential or other legislative requirements may be demonstrated not only by harmonised standards referenced in the OJEU but also by other standards or technical specifications.











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This is essential because not every harmonised standard has to cover all possible products and/or essential requirements.









The application of harmonised standards is not the only means to demonstrate the conformity of a product.
The manufacturers can choose whether or not to apply and refer to harmonised standards. However, if manufacturers choose not to apply harmonised standards, they have the obligation to demonstrate that their products are in conformity with essential requirements by the use of other means of their own choice that provide for the level of safety or protection of other interests required by the applicable legislation. These can be other standards such as national standards, international standards, European standards the references of which are not published in the OJEU, or other technical specifications such as European standardisation deliverables (200) (deliverables other than European standards developed by the ESOs), or the manufacturer’s own specifications. In these cases the manufacturers do not benefit from the presumption of conformity, but have to demonstrate the conformity themselves. This implies that they demonstrate, in the technical file of a relevant product, in a more detailed manner how the standards or technical specifications they use provide conformity with the essential requirements (201), for instance by carrying out a more in-depth risk assessment on the product, a gap analysis, etc.
It is important to stress that Union harmonisation legislation for products does not, as a general rule, impose the use of harmonised standards. Only essential requirements are legally binding and manufacturers may apply whatever standards and technical specifications – however only harmonised standards which references are published in the OJEU provide a presumption of conformity.
Some Union harmonisation legislation (202) which relies on harmonised standards provides for certain alternatives or complementary means to harmonised standards for demonstrating compliance of a product or a service. Some of these alternatives are mandatory (203) while others provide a presumption of conformity in a similar manner as harmonised standards (204). As a rule, these alternatives are foreseen as a fall-back option mainly for situations where harmonised standards do not exist (yet) and harmonised standards remain the preferred option.
4.2.   Traceability requirements












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The traceability requirements allow tracing the history of the product and support market surveillance. It allows market surveillance authorities to find the liable economic operators and obtain evidence of the product compliance.











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The traceability requirements include labelling the product and identifying the economic operators in the distribution chain.









4.2.1.   
Why does Traceability matter?


Traceability is the ability to trace the history of the product.
From a regulator’s perspective, traceability matters because it enables effective enforcement through market surveillance via corrective measures including withdrawals and recalls. It enables unsafe or non-compliant products to be traced up the distribution chain and identifies roles and responsibilities of the economic operator throughout the chain. Traceability enables market surveillance authorities to trace products up to the factory gate and from factory to the end-user in certain cases.
From a manufacturer’s perspective traceability matters because it enables effective control of the production process and suppliers before the marketing of the products, and control of their distribution chain after the placing of the product on the market. In case of non-compliance, manufacturers are able to reduce the impact of recalls or withdrawals depending on the detail of their traceability system.
4.2.2.   
Traceability provisions


Union harmonisation legislation is prescriptive as to the ends but not as to the means to achieve those ends. This means that Union harmonisation legislation foresees requirements for the traceability of products made available on the market, without stipulating how to achieve or implement these requirements. Union harmonisation legislation is also technology-neutral, meaning it does not prescribe the technology to be used such as printing or moulding. Manufacturers should choose the traceability system which they deem most appropriate in relation to their products and their manufacturing and distribution system.
The indication of the manufacturer’s, and for imported products also the importer’s, name and address on the product is a basic traceability requirement. Products within the scope of application of Article 4 of Regulation (EU) 2019/1020 must indicate the name and address of the economic operator referred to in Article 4 established in the EU. In case of need, it allows market surveillance authorities to quickly get in contact with the economic operator responsible for the placing of an unsafe or non-compliant product on the Union market.
There is no explicit obligation that the addresses have to be preceded by the words ‘Manufactured by’, ‘Imported by’ or ‘Represented by’ or ‘Fulfilled by’. This information must however not mislead the end-user and the market surveillance authorities about the place of manufacture and the address of each economic operator (205). If these words are not mentioned, market surveillance authorities will decide what the role of each economic operator is. It is then up to the economic operator to prove that he has a different role.
There is no obligation to translate into all necessary languages the English terms ‘manufactured by’, ‘imported by’ or ‘represented by’. These English terms are considered to be easily understandable throughout the EU.
Regulation (EU) 2019/1020 on market surveillance and compliance of products and Decision No 768/2008/EC on a common framework for the marketing of products establish the current practices regarding traceability by requiring specific traceability labels. The reference provisions of Decision No 768/2008/EC reflected in Union harmonisation legislation, as well as Regulation (EU) 2019/1020, require:






1.


manufacturers to indicate the following elements: their (1) name, registered trade name or registered trade mark (206) and (2) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted (207);










2.


importers to indicate the following elements: their (1) name, registered trade name or registered trade mark and (2) the address at which they can be contacted, on the product or, where that is not possible, on its packaging or in a document accompanying the product; (208)











3.


economic operators referred to in Article 4 of Regulation (EU) 2019/1020, to indicate their (1) name, registered trade name or registered trade mark, and (2) contact details, including the postal address, on the product or on its packaging, the parcel or an accompanying document (209), for products which are included within the scope of Article 4 and placed on the Union market;










4.


manufacturers to ensure that their products bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product (210) and










5.


economic operators to identify any economic operator who has supplied them with a product and any economic operator to whom they have supplied a product (211).




Unless otherwise specified by Union harmonisation legislation, the information on the name and address of the different economic operators does not need to be affixed indelibly, as opposed to other information on the product such as the CE marking. However, this information should be visible on the product, or on the packaging or accompanying documentation.
4.2.2.1.   The requirement to indicate name and address for manufacturers

Manufacturers must indicate the following three elements: their (1) name, registered trade name or registered trade mark and (2) the address at which they can be contacted on the product, or, where that is not possible, on its packaging and / or in a document accompanying the product.
The name and address must, as a rule, be affixed to the product. However, it may exceptionally be moved from the product if this rule cannot be followed. This would be justified where affixing it to the product was not possible under reasonable technical or economic conditions excluding however esthetical reasons. It is up to the manufacturer to make this assessment. This assessment has to be done according to the size or nature of the product (212). Some products e.g. hearing aids, sensors or the like are simply too small to carry such information. In such cases the order of priority is that as a first alternative the information should be on the packaging, as a second alternative on an accompanying document such as the instructions for use, except for the cases where sectoral Union harmonisation legislation requires the information to be on both the packaging and accompanying documents.
The manufacturer has to comply with this obligation regardless of his location (within or outside the EU). This provision implies that products sold without packaging or any accompanying documents, must bear the name and address of the manufacturer on the product itself.
The address must indicate a single point at which the manufacturer can be contacted, in particular by market surveillance authorities. The legal text obliges the manufacturer to put a single contact point on the product. Only one single contact point in each product is allowed. This is not necessarily the address where the manufacturer is actually established. This address can for example be the one of the authorised representative or of the customer services.
The single contact point does not need to be in every Member State where the product is made available. The manufacturer may however put other addresses (213) provided that it is clear which one is the single contact point. The latter is then to be indicated on the product/documentation as the ‘single contact point’. The address or the country does not necessarily have to be translated into the language of the Member State where the product is made available on the market but the characters of the language used must allow identifying the origin and the name of the company.
A website address may be given in addition to, but not instead of a postal address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.
4.2.2.2.   The requirement to indicate name and address for importers

Importers must also indicate the following elements: their (1) name, registered trade name or registered trade mark and (2) the address at which they can be contacted on the product, or, where that is not possible, on its packaging or in a document accompanying the product. The provision refers to an address at which they can be contacted, in particular by market surveillance authorities. This is not necessarily the address where the importer is actually established but can for example be the one of the customer services.
As a rule, the identification and the address of importer must be indicated on the product. Only where it is not possible, the identification and address of the importer may be indicated on the packaging and / or in a document accompanying the product. This may be the case when the importer would have to open the packaging to put his name and address. The additional information from the importer shall not hide the information put on the product by the manufacturer.
A website address may be given in addition to, but not instead of a postal address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.
4.2.2.3.   The requirement to indicate the name and address of the economic operator referred to in Article 4 of Regulation (EU) 2019/1020

Where the product falls within the scope of legislation listed in Article 4(5) of Regulation (EU) 2019/1020 and is placed on the Union market, the economic operators referred to in Article 4 must indicate their (1) name, registered name or registered trade mark and (2) their contact details, including a postal address on the product or on its packaging, the parcel or an accompanying document.
A website address may be given in addition to, but not instead of a postal address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.
4.2.2.4.   Possible scenarios

The product must always bear the manufacturer’s name and address. Imported products must also bear the importer’s name and address. Products under the scope of Article 4 of Regulation (EU) 2019/1020 and placed on the Union market must bear the name and address of the responsible economic operator established in the EU. Hence, in conclusion, a product normally bears one or two addresses (214):






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If the manufacturer is within the European Union, the product will bear only one (manufacturer’s) address as there is no importer involved.










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If the manufacturer (declaring himself as a manufacturer by putting his name and address on the product) is outside the EU and the products are placed on the Union market by an importer, the product will bear two addresses: the one of the manufacturer and the one of the importer.










—


If the original manufacturer is outside the EU and the importer places the product on the market under his own name or trademark or modifies the product already placed on the market (in such a way that compliance with the applicable requirements may be affected), the importer is considered the manufacturer. The only address that in this case will figure on the product (or packaging or accompanying document) is the address of the importer who is considered as the manufacturer (215) (216).










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If the manufacturer is within the EU (a company located in the EU declaring itself to be a manufacturer by putting its name and address on the product) although the products are manufactured outside the EU, that company is considered to be the manufacturer who places the product on the Union market, even if actual importation is done by another company. In this case there is no importer in the meaning of the importer’s definition and it is sufficient to put only the manufacturer’s address.










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Where the product falls within the scope of Article 4 of Regulation (EU) 2019/1020 and is placed on the Union market, if the manufacturer is located outside the EU, there is no importer for the product (because it is shipped directly or via fulfilment service provider to the end-user from outside the Union), and the manufacturer has appointed an authorised representative to fulfil on its behalf the tasks of Article 4(3), the product will have to include two addresses (or the packaging or accompanying document, or for the economic operator referred to in Article 4, the parcel): the manufacturer’s and the authorised representative’s as the economic operator referred to in Article 4. This will also be the case if the manufacturer is established inside the EU but has appointed an authorised representative to fulfil on its behalf the tasks of Article 4(3).










—


Where the product falls within the scope of Article 4 of Regulation (EU) 2019/1020 and is placed on the Union market, if the manufacturer is located outside the EU, there is no importer and the manufacturer has not appointed an authorised representative, but the product is handled by a fulfilment service provider established in the EU, two addresses must be indicated on the product (or the packaging or accompanying document, or for the economic operator referred to in Article 4, the parcel): the manufacturer’s and the fulfilment service provider’s as the economic operator referred to in Article 4.




4.2.2.5.   Identification element

The product must bear a type, batch, serial or model number or other element allowing its identification. The identification must, as a rule, be affixed to the product. However, it may exceptionally be moved from the product if this rule cannot be followed. This would be justified where the size and/or the nature of the product makes the indication illegible or technically impossible (217). In such cases, the identification has to be affixed to the packaging, if it exists, and/or to the accompanying document. The identification on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic or economic grounds. It is up to the manufacturer to make this assessment.
This provision implies that if the product has no packaging or is not accompanied by any document, the identification must be on the product itself.
The requirement gives the freedom to the manufacturers to choose the element they want to use as identification of the product, as long as traceability is ensured. The identification element used must ensure a clear link to the relevant documentation that demonstrates the conformity of the specific type of product, in particular the EU Declaration of Conformity. This identification element of the product shall be the same as on the EU Declaration of Conformity. The identification element chosen by the manufacturer is also important in case of a withdrawal or recall, since all products bearing the same identification element will have to be withdrawn or recalled from the market.
In some cases, e.g. when a product consists of several parts or is an assembly of several parts, its nature does not allow for the affixing of the identification element. The identification of the product has in these cases to be affixed to the packaging (or accompanying document). In addition to the marking with an identification element on the packaging, additional marking of individual products/parts/components can be made based on the manufacturer’s internal rules and ambitions to minimise the extent of a potential recall by having an advanced system for traceability of individual items (e.g. batch codes, production dates).
According to some economic operators, one way to refer to products is to use an item number (a so-called ‘SKU’-’Stock keeping unit’) as identification. This item number can also be used as an identifier on the EU Declaration of Conformity together with other elements allowing traceability.

The product consists of several parts/components

Each product is enclosed in one packaging but typically some parts/components could/would also be sold in another packaging as separate parts/components or in other combinations of parts/components. Some of the parts/components in these packages may be possible to mark, while others may be too small or have a shape which does not allow the marking to be on the part. For these reasons, it is allowed to give the set/packaging an item number and to use the same item number on the EU Declaration of Conformity.
The main purpose of the identification element is to enable market surveillance authorities to identify an individual product and to link it to an EU Declaration of Conformity. If, when the market surveillance takes place, the product is still in its packaging, it will be easy to identify the element and thus ensure that the corresponding EU Declaration of Conformity regards the product in question. It would be more complicated to have to open the packaging and find elements on the individual items and then link these to a particular EU Declaration of Conformity.

The product consists of one assembled item

Also when a product consists of only one ‘item’, it is not uncommon that this item has been assembled by the manufacturer, using several parts (but it is not intended to be disassembled by the consumer). The parts composing the item (product) are often used in more than one design of products. Normally, some parts would not be large enough to bear an identification element and yet other parts might not allow marking with an identification element for technical reasons (uneven surface, spherical shaped surface etc.). Also in this case it is allowed to affix an item number on the packaging and to use the same number on the EU Declaration of Conformity.

The product consists of one item which has not been assembled of several parts

This is a case where it may seem simple to mark the product itself with an identification element that is identical to the one on the EU Declaration of Conformity (i.e. an item number). However, the same product might be sold in combination with other products/items in a set. Since at the point of production, it is not known which of the items will be sold ‘alone’ and which will be in a packaging together with other products, it is easier to mark the item number, corresponding to the EU Declaration of Conformity, on the packaging. This will also facilitate market surveillance authorities to link the product to the EU Declaration of Conformity.
4.2.2.6.   Identification of economic operators

Economic operators are obliged to keep track of the economic operators they supplied their product to or from whom they bought products for a period of 10 years or other time period provided for in specific Union harmonisation legislation. The end user (consumer) is not covered by this requirement as they are not considered to be economic operators.
The way to comply with this requirement by economic operators is not prescribed by Union harmonisation legislation, but it must be noted that market surveillance authorities can ask for relevant documents, including invoices, allowing the origin of the product to be traced. Hence, it could be useful to keep invoices for a longer period than envisaged in accounting legislation to comply with the requirements on traceability.
4.3.   Technical documentation












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The manufacturer must draw up a technical documentation.











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The technical documentation is intended to provide information on the design, manufacture and operation of the product.









Union harmonisation legislation obliges the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements. This documentation may be part of the quality system documentation where the legislation provides for a conformity assessment procedure based on a quality system (modules D, E, H and their variants). The technical documentation must be available when the product is placed on the market, whatever its geographical origin or location (218).
The technical documentation must be kept for 10 years from the date of placing the product on the market, unless the applicable Union harmonisation legislation expressly provides for any other duration (219). This is the responsibility of the manufacturer or the authorised representative established within the Union. Since the concept of ‘placing on the market’ refers to each individual product, the time period needs to be calculated from the moment when the individual product that is covered by the technical documentation is placed on the market.
The contents of the technical documentation are laid down, in each Union harmonisation act, in accordance with the products concerned. As a rule, the documentation has to include a description of the product and of its intended use and cover the design, manufacture and operation of the product. The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant Union harmonisation legislation or, if the harmonised standards have been applied, to these by indicating the essential requirements covered by the standards. The requirements in Annex II of Decision No 768/2008/ EC refer to the contents of the technical documentation that are relevant for proving the conformity of the product with the applicable harmonisation legislation. Furthermore, the requirement for an ‘adequate analysis and assessment of the risk(s)’ requires the manufacturer to first identify all possible risks of the product and determine the specific Union harmonisation legislation and essential requirements applicable. This analysis has to be documented and included in the technical documentation. In addition, the manufacturer needs to document the assessment of how he is addressing the risks identified to ensure that the product complies with the applicable essential requirements (for example, by applying harmonised standards). If only part of the harmonised standard is applied or it does not cover all applicable essential requirements, then also the way applicable essential requirements not covered by it are dealt with should be documented in the technical documentation.
In the case where a product has been subject to re-designs and re-assessments of the conformity, the technical documentation must reflect all versions of the product; describing the changes made, how the various versions of the product can be identified and information on the various conformity assessment. This is to avoid situations where during the whole life of a product, a market surveillance authority is faced with previous versions of the product for which the version of the technical documentation it is presented with, is not applicable.
Some Union harmonisation acts require that the technical documentation is written in a language accepted by the notified body (220). In order to carry out the conformity assessment procedures requiring third-party verification in a proper way, the documentation should always be in a language understood by the notified body, even if this has not been explicitly mentioned in the Union harmonisation legislation.
4.4.   EU declaration of conformity












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The manufacturer or the authorised representative established within the Union must draw up and sign an EU Declaration of Conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation.











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The EU Declaration of Conformity must contain all relevant information to identify the Union harmonisation legislation according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other technical specifications.











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A single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU Declaration of Conformity.











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The single declaration of conformity can be made up of a dossier containing all relevant individual declarations of conformity.









Union harmonisation legislation imposes an obligation on the manufacturer to draw up and sign an EU Declaration of Conformity before placing a product on the market (221). The manufacturer or his authorised representative established within the Union must draw up and sign an EU Declaration of Conformity as part of the conformity assessment procedure provided for in the Union harmonisation legislation. The EU declaration of conformity is the document that states that the product satisfies all the relevant requirements of the applicable legislation.
By drawing up and signing the EU Declaration of Conformity, the manufacturer assumes responsibility for the compliance of the product.
Just as it is the case for the technical documentation (222), the EU Declaration of Conformity must be kept for ten years from the date of placing the product on the market, unless the legislation provides for any other duration (223). This is the responsibility of the manufacturer or the authorised representative established within the Union. For imported products, the importer must take on this responsibility for the Declaration of Conformity (224).
The EU Declaration of Conformity must be kept up to date (225). The EU Declaration of Conformity is specific to each individual product, even if they are manufactured in series. In practice, the same version of the EU Declaration of conformity may be applicable to many individual products which are manufactured in series. However, as soon as any of the elements of the EU declaration of conformity changes, the version of the EU declaration of conformity will have to be updated for products placed on the market after that change. Such changes may for example be changes in the legislation, changes in the versions of the harmonised standards or changes in the contact details of the manufacturer or authorised representative.
The contents of the EU Declaration of Conformity either refer to the model declaration contained in Annex III of Decision No 768/2008/EC or a model declaration directly annexed to the sectoral Union harmonisation legislation at stake. The standard EN ISO/IEC 17050-1 has been drawn up with the objective of providing the general criteria for the declaration of conformity, and it can also be used as a guidance document provided it is in line with the applicable Union harmonisation legislation. The declaration may take the form of a document, a label or equivalent, and must contain sufficient information to enable all products covered by it to be traced back to it.
The model declaration of Decision No 768/2008/EC contains:






1.


A number identifying the product. This number does not need to be unique to each product. It could refer to a product, batch, type or a serial number (226). This is left to the discretion of the manufacturer (227).










2.


The name and address of the manufacturer or the authorised representative issuing the declaration.










3.


A statement that the declaration is issued under the sole responsibility of the manufacturer.










4.


The identification of the product allowing traceability. This is basically any relevant information supplementary to point 1 describing the product and allowing for its traceability. It may where relevant for the identification of the product contain an image, but unless specified as a requirement in the Union harmonisation legislation this is left to the discretion of the manufacturer.










5.


All relevant Union harmonisation legislation complied with the referenced standards or other technical specifications (such as national technical standards and specifications) in a precise, complete and clearly defined way; this implies that the version and/or date of the relevant standard is specified.










6.


The name and identification number of the notified body or bodies when they have been involved in the conformity assessment procedure (228) (229) and the reference to the relevant certificate(s), if applicable.










7.


All supplementary information that may be required (for example grade, category), if applicable.










8.


The date of issue of the declaration; signature and title or an equivalent marking of authorised person (230) (231); this could be any date after the completion of the conformity assessment




Where several pieces of Union harmonisation legislation apply to a product, the manufacturer or the authorised representative has to provide a single declaration of conformity in respect of all such Union acts (232). In order to reduce the administrative burden on economic operators and facilitate its adaptation to the modification of one of the applicable Union acts, the single declaration may be a dossier made up of relevant individual Declarations of conformity (233).
The EU declaration of conformity must be made available to the surveillance authority upon request. Moreover, Union harmonisation legislation relating to machinery, equipment in potentially explosive atmospheres, radio equipment, measuring instruments, recreational craft, lifts, high-speed and conventional rail systems and constituents of the European Air Traffic Management network require products to be accompanied by the EU declaration of conformity.
The EU declaration of conformity must be translated into the language or languages required by the Member State in which the product is placed or made available on the market (234). Union harmonisation legislation does not necessarily specify who has the obligation to translate. Logically, this should be the manufacturer or another economic operator making the product available. The EU declaration of conformity must be signed by the manufacturer or his authorised representative. If a translation of the EU declaration of conformity has been produced by another economic operator and is not signed by the manufacturer, a copy of the original EU declaration of conformity signed by the manufacturer must also be provided together with the translated version.
4.5.   Marking requirements

4.5.1.   
CE marking


4.5.1.1.   Definition and role of the CE marking












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The CE marking indicates the conformity of the product with the Union legislation applying to the product and providing for CE marking.











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The CE marking is affixed on products that will be placed on the EEA and Turkish market, whether they are manufactured in the EEA, in Turkey or in another country.









The CE marking is a key indicator (but not proof) of a product’s compliance with EU legislation and enables the free movement of products within the EEA and Turkish market, whether they are manufactured in the EEA, Turkey or in another country.
Member States of the European Economic Area (EEA - EU Member States and certain EFTA countries: Iceland, Norway, Liechtenstein) are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. This also applies to products made in third countries which are sold in the EEA.
CE marking does not indicate that a product was made in the European Union. The CE marking indicates conformity with the requirements laid down by the Union harmonisation text(s) in question. Therefore, it is to be considered as essential information to Member States’ authorities as well as other relevant parties (for example distributors). CE marking does not serve commercial purposes i.e. it is not a marketing tool.
CE marking is the visible consequence of a whole process comprising conformity assessment in a broad sense and indicates that a product is declared by the manufacturer as in conformity with Union harmonisation legislation.
4.5.1.2.   Relationship to existing legislation












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Regulation (EC) No 765/2008 lays down the general principles governing the CE marking while Decision No 768/2008/EC provides for rules governing its affixing.











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Sectoral Union harmonisation texts providing for CE marking are based on Regulation (EC) No 765/2008 and Decision No 768/2008/EC.









Regulation (EC) No 765/2008 lays down the definition, the format and the general principles governing the CE marking. Decision No 768/2008/EC provides for conformity assessment procedures that lead to its affixing.
The sectoral Union harmonisation legislation providing for the affixing of the CE marking mostly follows the principles of the Regulation (EC) No 765/2008 and Decision No 768/2008/EC.
As a general rule (235) the CE marking can be introduced in a Union legislative act as legal conformity marking if:






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the method of total harmonisation is used, which means that diverging national regulations that cover the areas as the legislative act in question are prohibited;










—


the Union harmonisation act contains conformity assessment procedures according to Decision No 768/2008/EC.




However there is an exception to this rule.
In duly justified cases a total harmonisation piece of legislation that follows Decision No 768/2008/EC may provide for a different marking instead of the CE marking. For example the Directive on marine equipment does not provide for a CE marking, but for a specific conformity mark - the wheel mark. - The use of the wheel mark also is subject to the general principles set out in Regulation (EC) No 765/2008 and Decision No 768/2008/EC and any reference to CE marking is to be construed as a reference to the wheel mark. Similarly, for transportable pressure equipment, the ‘Pi’ marking is required instead of the CE marking.
4.5.1.3.   Who must (not) affix the CE marking












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The CE marking is affixed by the manufacturer (established inside or outside the Union), or by his authorised representative established within the Union.











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By affixing the CE marking the manufacturer declares on his sole responsibility that the product conforms to all applicable Union legislative requirements, and that the appropriate conformity assessment procedures have been successfully completed.








The manufacturer, whether established inside or outside the Union, is the entity ultimately responsible for the conformity of the product with the provisions of the Union harmonisation legislation and for the affixing of the CE marking. The manufacturer may mandate an authorised representative to affix the CE marking on his behalf.
By affixing the CE marking on a product, a manufacturer is declaring, on his sole responsibility (and irrespectively of whether a third-party has been involved in the conformity assessment process), conformity with all of the legal requirements to achieve CE marking.
If the importer or distributor or another operator places products on the market under his own name or trademark or modifies them, he then takes over the manufacturer’s responsibilities. This includes the responsibility for the conformity of the product and the affixing of the CE marking. In this case he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.
4.5.1.4.   Principles of affixing the CE marking







The CE marking must take the form below. If the CE marking is reduced or enlarged the proportions must be respected.








  The CE marking must be affixed visibly, legibly and indelibly to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and/or to the accompanying documents. The CE marking may not, in principle, be affixed until the conformity assessment procedure has been completed to ensure that the product complies with all the provisions of the relevant Union harmonisation acts. This will usually be at the end of the production phase. This poses no problem if, for example, the CE marking is on a data plate that is not affixed to the product until after the final inspection. However, if (for example) the CE marking is affixed by stamping or casting, the marking can be affixed at any other stage of the production phase, provided that the conformity of the product is verified as part of the production process.
The requirement for visibility means that the CE marking must be easily accessible for all parties. It could, for instance, be affixed on the back or underside of a product. The requirement for visibility does not necessarily mean that the CE marking must be visible before opening a products’ packaging because affixing the CE marking also to the packaging is only necessary in case this is explicitly required in the relevant Union acts. For products requiring assembly, the CE marking should remain visible after assembly but does not need to be visible after final installation and in normal use. A minimum height of 5 mm is required to ensure that it is legible. However according to the several pieces of legislation (236) the minimum dimension of the CE marking may be waived for small devices or components.
The CE marking can take different forms (e.g. colour, solid/hollow) as long as it remains visible, legible and respects its proportions. It must also be indelible so that it cannot be removed under normal circumstances without leaving noticeable traces (for example some product standards provide for a rub test with water and petroleum spirits). It is up to the manufacturer to ensure that its technological solution satisfies the requirements of visibility, legibility and indelibility. (237) Nevertheless, this does not mean that the CE marking must form an integral part of the product.
However in certain cases affixing of the CE marking to the product is impossible (for example on certain types of explosives) or not possible under reasonable technical or economic conditions. Furthermore there can be cases where the minimum dimensions for the affixing cannot be respected, or it cannot be ensured that the CE marking is visibly, legibly and indelibly affixed.
In such cases, the CE marking can be affixed to the packaging, if it exists, and / or to the accompanying document, where the Union harmonisation legislation concerned provides for such documents. The CE marking on the product may neither be omitted nor be moved to the packaging or accompanying documents on purely aesthetic grounds.
Regulation (EC) No 765/2008 and Decision No 768/2008/EC lay down that the CE marking must have the dimensions, format and proportions defined in Annex II of Regulation (EC) No 765/2008 and be legible and clearly affixed. Regulation (EC) No 765/2008 and Decision No 768/2008/EC do not forbid any kind of design (e.g. ‘hollow’ design) as long as the above conditions are respected. However, electronic labelling only is not allowed.
In addition, 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 are visible before the end user is carrying out the purchase.
4.5.1.5.   Affixing CE marking together with the identification number of the notified body

Where a notified body is involved in the production control phase according to the applicable Union harmonisation legislation, its identification number must follow the CE marking. The manufacturer or the authorised representative affixes the identification number if the legislation so requires, under the responsibility of the notified body.
A notified body may be involved in the production phase, depending on the conformity assessment procedures applied. The CE marking must be followed by the identification number of the notified body only if it is involved in the production phase. Thus, the identification number of a notified body involved in conformity assessment in the design phase according to module B does not follow the CE marking. Sometimes several notified bodies are involved in the production phase, which is possible where more than one Union harmonisation text is applicable. In these situations several identification numbers follow the CE marking.
Thus, if the CE marking appears on products without an identification number, this means that:






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either no notified body intervened in the design or production phase (module A);










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or upon manufacturer’s choice the in-house accredited body intervened in the production phase (modules A1, A2);










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or a notified body intervened in the design phase (module B) but no notified body intervened in the production phase (module C following module B);










—


or a notified body intervened in the design phase (module B) and upon manufacturer’s choice the in-house accredited body intervened in the production phase (modules C1, C2 following module B).




If however the CE marking appears on products with an identification number (238), this means that:






—


either upon manufacturer’s choice a notified body intervened in the production phase (modules A1, A2);










—


or a notified body intervened in the design phase (module B) and upon manufacturer’s choice a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2 following module B);










—


or a notified body intervened in the design phase (module B) and a notified body (not necessarily the same one but the one whose identification number appears) intervened in the production phase (modules C1, C2, D, E, F following module B);










—


or a notified body intervened in the design and production phase (modules D1, E1, F1, G1 H, H1).




The CE marking and the identification number of the notified body do not necessarily have to be affixed within the Union. They may be affixed in a third country, for example if the product is manufactured there and the notified body carried out conformity assessment in that country in line with the relevant Union harmonisation legislation. The CE marking and the identification number can also be affixed separately, as long as they remain combined.
4.5.1.6.   Which products must (not) be CE marked












—



The CE marking must be affixed before any product subject to it, is placed on the market, save where specific Union harmonisation legislation requires otherwise.











—



Where products are subject to several Union harmonisation acts, which provide for the affixing of the CE marking, the marking indicates that the products are declared to conform to the provisions of all these acts.











—



A product may not be CE marked, unless it is covered by a Union harmonisation legislation providing for its affixing.









Not all products have to be CE marked (239). The obligation to affix the CE marking extends to all products within the scope of legislative acts providing for its affixing, and which are intended for the Union market. Thus, the CE marking must be affixed:






—


to all newly manufactured products that are subject to legislation providing for CE marking, whether manufactured in the Member States or in third countries;










—


to used and second-hand products imported from third countries that are subject to legislation providing for CE marking;










—


to substantially modified products that, as new, are subject to legislation providing for CE marking and which have been modified in a way that could affect the safety or the compliance of the product with the applicable harmonisation legislation.




In some cases, a product is deemed final for the purposes of a particular Union harmonisation act and has to be CE marked. This same product then is incorporated in another final product which is itself subject to another Union harmonisation act which also requires CE marking. This produces a situation where more than one CE marking can be found on a product (240).
Union harmonisation legislation providing in general for CE marking may exclude the application of the CE marking on certain products. As a general rule, such products are subject to free circulation, if:






a.


They are accompanied by:






—


a Declaration of incorporation for partly completed machinery, according to the Machinery Directive;










—


a Declaration by the manufacturer or the importer in the case of partly completed watercraft referred to in the Directive on recreational craft and personal watercraft.














b.


They are accompanied by an attestation of conformity in the case of components as defined in the Directive on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX).










c.


They are accompanied by a statement in the case of:






—


custom-made medical devices and devices intended for clinical investigations referred to in the legislation on medical devices;










—


devices intended for performance evaluation referred to in the legislation on in vitro diagnostic medical devices.














d.


They are accompanied by a certificate of conformity in the case of fittings referred to in the Directive relating to gas appliances.










e.


The product bears the manufacturer’s name and an indication of maximum capacity in the case of instruments not subject to conformity assessment according to the Directive relating to non-automatic weighing instruments.










f.


The product is manufactured in accordance with sound engineering practice in the case of certain vessels referred to in the Directives relating to simple pressure vessels and pressure equipment.




In addition, the Directive on pressure equipment entitles Member States to authorise, on their territory, the placing on the market and the putting into service by users, of pressure equipment or assemblies not bearing the CE marking, but that have been subject to a conformity assessment carried out by a user inspectorate instead of a notified body.
4.5.1.7.   CE marking and other markings












—



The CE marking is the only marking of conformity indicating that a product is in conformity with Union harmonisation legislation that applies to it and provides for CE marking.











—



Member States must refrain from introducing any reference to another conformity marking into their national regulations, which would overlap with the CE marking.











—



A product may bear additional markings and marks, provided that they fulfil a different function from that of the CE marking, are not liable to cause confusion with it, and do not reduce its legibility and visibility.









The CE marking replaces all mandatory conformity markings having the same meaning, which existed before harmonisation took place. Such national conformity markings are incompatible with CE marking and would constitute an infringement of the applicable European legislation in question. When transposing Union harmonisation legislation, Member States are required to incorporate the CE marking into their national regulations and administrative procedures. They must also refrain from introducing any other conformity marking into their national legislation that has the same meaning as the CE marking.
However, other markings may be used as long as they contribute to the protection of public interests, are not covered by Union harmonisation legislation and their affixing does not impair the visibility, legibility and meaning of the CE marking. The affixing of additional markings (such as a protected trademark of a manufacturer or other private/national markings) is allowed to the extent that such markings do not create confusion with the CE marking. This confusion may either refer to the meaning or form of the CE marking.
In this respect, other markings additional to the CE marking need to fulfil a different function from that of the CE marking. Thus, they should provide information on conformity with objectives that are different from those to which the CE marking relates (for example environmental aspects not covered by the applicable Union harmonisation legislation).
Furthermore several Union harmonisation acts foresee additional markings that are complementary and non-overlapping to the CE marking (see under 4.5.2).
4.5.1.8.   Sanctions












—



Member States have to ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking.











—



Member States have to also provide for penalties for infringements, which may include criminal sanctions for serious infringements.











—



A Member State must notify to the Commission and to the other Member States when it decides to restrict free movement due to incorrect affixing of the CE marking, or when it takes action against those who are responsible for a non-compliant product bearing the CE marking.









The CE marking provides the first indication that the necessary controls can be assumed to have been carried out, before the product in question is placed on the market, in order to ensure its compliance to the legislative requirements. Market surveillance authorities are entitled to proceed to additional controls for the protection of public interest. The action to be taken by market surveillance authorities should be decided on a case by case basis according to the principle of proportionality.
Member States must provide in their national legislation for appropriate measures both to prevent the abuse and misuse of CE marking, and to redress the situation if such abuse or misuse takes place. Those measures need to be effective, proportionate to the seriousness of the offence and dissuasive and may be increased if the relevant economic operator has previously committed a similar infringement. They may include withdrawal, recall of products, penalties and criminal sanctions (such as fines and imprisonment) wherever necessary.
The measures are imposed without prejudice to other measures taken where the market surveillance authorities find that a product presents a risk or does not comply with the applicable legislation. Furthermore Member States must ensure that the measures are implemented.
In this respect the affixing of the CE marking to a product that is not covered by any of the Union harmonisation legislation providing for its affixing is considered to be deceiving because consumers or users, for instance, are likely to get the impression that the product in question satisfies certain Union harmonisation legislation provisions. Competent authorities must, therefore, have at their disposal legal instruments that enable them to act against the deceptive use of CE marking. Action must be taken also against those responsible for a non-compliant product bearing the CE marking.
The affixing of markings in addition to the CE marking is subject to certain restrictions (241). The surveillance authority has to take the necessary measures to ensure that these principles are respected and, where necessary, take appropriate action.
A Member State must inform the Commission and the other Member States of its decision to restrict free movement due to incorrect affixing of the CE marking, and of its action against the person responsible for affixing the CE marking to a non- compliant product. It is then up to the other Member States to decide whether or not similar action is necessary. In the case of unduly affixed CE marking to products not subject to the CE marking requirement, Member States should inform the Commission and the other Member States about it.
4.5.2.   
Other mandatory markings








Several pieces of Union harmonisation legislation foresee additional markings that are complementary and non-overlapping to the CE marking.





Pictograms or other markings indicating, for instance, the category of use are, according to some Union harmonisation legislation, complementary to the CE marking but do not form part of it or replace it. In general, these markings follow the same principles as the CE marking. Some examples:






—


the EU energy label for energy-related products;










—


the specific marking of explosion protection required for equipment and protective systems intended for use in potentially explosive atmospheres;










—


the supplementary metrology marking required for measuring instruments and non-automatic weighing instruments.




5.   CONFORMITY ASSESSMENT

5.1.   Modules for conformity assessment

5.1.1.   
What is a conformity assessment?













—



Conformity assessment is the process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.











—



A product is subjected to conformity assessment both during the design and production phase.









Two important elements of every legislative act covering products are:






—


the legislative requirements governing the characteristics of the products covered;










—


and the conformity assessment procedures the manufacturer carries out in order to demonstrate that a product, before it is placed on the market, conforms to these legislative requirements.




This guide addresses conformity assessment as this is laid down under Decision No 768/2008/EC (particularly for the Union harmonisation legislation under the ‘New Approach’ and now the New Legislative Framework).
A product is subjected to conformity assessment both during the design and production phase. Conformity assessment is the responsibility of the manufacturer. Should a manufacturer subcontract design or production, he still remains responsible for the execution of conformity assessment.
Conformity assessment must not be confused with market surveillance, which consists of controls by the national market surveillance authorities after the product has been placed on the market. However both techniques are complementary and equally necessary to ensure the protection of the public interests at stake and the smooth functioning of the internal market.
The essential objective of a conformity assessment procedure is to demonstrate that products placed on the market conform to the requirements expressed in the provisions of the relevant legislation.
5.1.2.   
The modular structure of conformity assessment in Union harmonisation legislation













—



In Union harmonisation legislation, conformity assessment procedures cover both design and production phases. They are composed of one or two modules. Some modules cover both phases. In other cases, distinct modules are used for each phase.











—



Decision No 768/2008/EC lays down the ‘horizontal menu’ of conformity assessment modules and the ways procedures are built of modules.











—



The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/ EC) the most appropriate ones for the concerned sector.









Under Union harmonisation legislation, conformity assessment procedures are composed of one or two conformity assessment modules. As products are subjected to conformity assessment both during the design and production phase, a conformity assessment procedure covers both design and production phases; while a module may cover:






—


either one of these two phases (in this case a conformity assessment procedure is composed of two modules);










—


or both (in this case a conformity assessment procedure is composed of one module).




Decision No 768/2008/EC, lays down a ‘horizontal menu’ of conformity assessment modules and the ways procedures are built of modules.
The legislator selects from the menu of conformity assessment modules/procedures (laid down under Decision No 768/2008/EC) the most appropriate one(s) in order to address the specific needs of the concerned sector (242). The least onerous modules should be selected taking into account the type of products and hazards involved, the impact on the protection of public interests, the economic infrastructure of the given sector, the methods of production etc. Where possible a choice of inspection, certification, and/or quality assurance modules should be provided.
Conformity assessment procedures are equivalent from a legal point of view but not technically identical in terms of methods. Their application in the sectoral legislation aims at providing high level of confidence as regards the conformity of products to the relevant essential requirements.
The intention of the modules as laid down in the Decision No 768/2008/EC is to allow for a limited number of possible procedures.
Nevertheless, the choice offered needs to be sufficiently varied in order to be applicable to the widest range of products concerned.
Union harmonisation legislation establishes conformity assessment procedures by either leaving the manufacturer no choice or by establishing a range of procedures from which the manufacturer must choose. As conformity assessment procedures in Union harmonisation legislation originate from Decision No 768/2008/EC, they remain consistent and coherent. Thus the assessment of product conformity becomes more transparent especially in cases where more than one harmonisation legislative act applies to a product.
5.1.3.   
Actors in conformity assessment – Positioning of conformity assessment in the supply chain













—



Conformity assessment is the responsibility of the manufacturer, whether the legislation provides for the involvement of a notified or in-house accredited conformity assessment body, or not.











—



The main actors in conformity assessment are the legislator, the manufacturer and (if provided for by the legislation) the notified or in-house accredited conformity assessment body.











—



The modules used for both the design and the production phase or for each phase may or may not involve a notified body.











—



In-house accredited conformity assessment bodies must demonstrate the same level of technical competence and impartiality as notified bodies.









Conformity assessment is a responsibility of the manufacturer. However, if required by the relevant legislation, a third party must be involved in the conformity assessment procedure.
In total there are three possibilities:






—


There is no third-party involvement. This may concern the case where, according to the legislator, a declaration (accompanied by the relevant technical examinations and documentation) of the manufacturer is enough to ensure the conformity of the product(s) in question against the relevant legislative requirements. In this case the manufacturer himself carries out all required controls and checks, establishes the technical documentation and ensures the conformity of the production process.










—


Conformity assessment is performed with the involvement of an accredited in-house conformity assessment body that forms a part of the manufacturer’s organisation. However this in-house body must not have any activities other than conformity assessment and must be independent from any commercial, design and production entities (see for details Article R21 of Annex I of Decision No 768/2008/EC). It has to demonstrate the same technical competence and impartiality as external conformity assessment bodies, through accreditation.










—


Whenever appropriate for a specific sector, the legislator may acknowledge the fact that manufacturers operate very well equipped testing laboratories or premises. This may be the case for new innovative complex products for which the testing know-how remains inside the manufacturers.










—


In some other cases the legislator may consider the intervention of a third party i.e. an external conformity assessment body, necessary. Such a body must be impartial and fully independent from the organisation or the product it assesses (see also Article R17(3) of Annex I of Decision No 768/2008/EC), it cannot engage in any activity that may conflict with its independence (see also Article R21(2)(c) of Annex I of Decision No 768/2008/EC) and thus it cannot have user or other interests in the product to be assessed.




It is the responsibility of the Member States to notify those third party conformity assessment bodies within their jurisdiction that they consider technically competent to assess the compliance of products with the requirements of the Union harmonisation legislation that applies to them. In-house bodies cannot be notified but they have still to demonstrate the same technical competence as external bodies, through accreditation. Member States must also ensure that the (in-house or external) bodies permanently maintain their technical competence.
Taking the above into account, the stakeholders in a conformity assessment procedure are the following:






a)


The legislator who:






—


sets out the legal requirements that products have to fulfil;










—


selects conformity assessment modules/procedures from the menu set out under Decision No 768/2008/EC.














b)


The manufacturer who:






—


designs, manufactures and tests the product or has it designed, manufactured or tested;










—


draws up the technical documentation of the product;










—


takes all measures necessary to ensure compliance of the products;










—


upon positive assessment of the products, draws up the EU Declaration of Conformity and affixes the CE marking on the products if the legislation so requires;










—


upon intervention of a notified body, affixes the notified body’s identification number to the product if the legislation so requires.




It must be clear that it is always the manufacturer who takes responsibility for the conformity of his products with the relevant legislative requirements. In this respect, the economic operator that places the product on the market under its name or trademark becomes automatically the manufacturer for the purposes of Union harmonisation legislation. Therefore he takes the entire responsibility for the conformity assessment (design and production) of the product, even if this has been actually done by somebody else. Furthermore he must be in the possession of all documentation and, where relevant, certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name.










c)


The (in-house or external) conformity assessment body that:






—


performs checks and assessments, if the legislation so provides;










—


upon positive assessment issues the approval certificate or attestation as required by the applicable legislation.








A conformity assessment body wishing to carry out conformity assessment for one or several module(s) under a given piece of Union harmonisation legislation has to be assessed according to all the requirements for the different modules it wishes to offer services for (see under 5.2.3). A body wishing to offer conformity assessment services under a Union harmonisation act has to offer services for at least one module from those indicated in the Union harmonisation act. It must be noted that there is no obligation for a body to offer services for more than one module, but it must take on the responsibility for a whole module.
The exact position of conformity assessment in the supply chain is depicted under Flowchart 2.

Flowchart 2


Conformity Assessment






5.1.4.   
Modules and their variants








There are eight modules. Some of them have variants.





There are eight modules (named with the letters from A to H). They lay down the responsibilities of the manufacturer (and his authorised representative) and the degree of involvement of the in-house accredited or notified conformity assessment body. They are the components of the conformity assessment procedures laid down under Decision No 768/2008/EC, the ‘horizontal menu’.
Several modules have their variants. The reason for providing variants within modules (this applies for all variants of all modules laid down under Decision No 768/2008/EC) is to enable the necessary level of protection to be ensured for products presenting higher level of risk while avoiding the imposition of a heavier module. The idea is to minimise the burden on manufacturers to the extent possible.
5.1.5.   
One- and two-module procedures – Procedures based on type (EU-type examination)








In some cases the conformity assessment procedure is in two steps:







—



first examination of the conformity of a specimen or the design of the concerned product;











—



then, determination of the conformity of the manufactured products against the approved specimen.









In some cases e.g. mass production based on a type/specimen ‘representative of the production envisaged’ and where the product in question is of complex design, the EU legislation may lay down the conformity assessment procedure in two steps:






—


first the examination of conformity of the type/specimen against the relevant legal requirements (so called EU-Type examination - module B);










—


and then the determination of the conformity of the manufactured products against the approved EU-type.




In these cases conformity assessment procedures are composed of two modules; the first module is always module B.
This method not only reduces burden and costs but is also more efficient compared to a traditional examination of the conformity products directly against the legal requirements. Once the type is approved (and this is done only once for a specific specimen), it must be checked only whether the products to be placed on the market are in conformity with the approved type.
The conformity assessment body involved under module B is not necessarily the same as the one involved in the module that is used together with module B. The date of issue of the certificate of the module issued together with module B must always be later as the date of the module B certificate. Both certificates must be available before the first placing of the product on the market.
In cases where there is no EU-type examination, conformity assessment procedures are composed of one two-phase (design & production) module.
The manufacturer undertaking the module (243) that is used together with module B does not need to be the same person as the one having the EU-type examination certificate under module B. Yet, that manufacturer placing then the product on the market, takes the entire responsibility for the conformity assessment (design & production) of the product. Consequently, he must be in possession of both certificates, although the EU-type examination certificate does not have to be in his name, and the full history of the product. It must be ensured in any case, that the certificate can be allocated to the product that is placed on the market without any doubt. He must have all the administrative and technical information and data, have the information on the type testing performed, manage the technical documentation related to the type testing and have batch testing performed. The above reasoning applies actually to all modules and procedures, independently of whether it is a one-phase or two-phase conformity assessment procedure. In cases where a manufacturer relies on one or more other manufacturer(s) for the design and production of the product there has to be proof that the manufacturer is fully informed about any changes in the design, production and conformity assessment of the product.
It is necessary that the certificate demonstrate that the appropriate module has been carried out in its entirety for the specific product it refers to.
5.1.6.   
Modules based on quality assurance













—



The use of quality assurance systems for the purpose of conformity assessment in the Union harmonisation legislation is described in modules D, E and H and their variants.











—



For the purpose of complying with the applicable legislation the manufacturer must ensure that the quality system is implemented and applied in such a way that it ensures full compliance of the products with the legislative requirements in question.











—



Compliance of the manufacturer with standards EN ISO 9000, EN ISO 9001, gives a presumption of conformity with the corresponding quality assurance modules as regards the legislative provisions covered by these standards.











—



In addition the quality system must take into consideration the specificities of the concerned products.









Some modules and their variants are based on quality assurance techniques and are derived from the EN ISO 9000 (244), EN ISO 9001 (245) standards. The modules based on quality assurance techniques (modules D, E, H and their variants) describe the elements a manufacturer must implement in his organisation in order to demonstrate that the product fulfils the essential requirements of the applicable legislation.
This means that a manufacturer is given the possibility of using an approved quality system for the purpose of demonstrating compliance with regulatory requirements. The quality system is assessed by the notified body.
A quality system implemented on the basis of the EN ISO 9000, EN ISO 9001 gives a presumption of conformity with the respective modules with regard to the provisions in the modules that these standards cover, provided that the quality system takes into consideration the specificities of the concerned products.
However, the manufacturer is free to apply other quality system models than those based on EN ISO 9001 for the purpose of complying with these modules.
In any case the manufacturer must specifically address all regulatory provisions while applying its quality system, in particular:






—


The quality objectives, quality planning and quality manual must fully take on board the objective of delivering products that conform to the essential requirements.










—


The manufacturer must identify and document the essential requirements that are relevant for the product and the harmonised standards or other technical solutions that will ensure fulfilment of these requirements.










—


The identified standards or other technical solutions must be used as design input, and as verification that design output ensures that the essential requirements will be met.










—


The measures taken to control manufacturing must ensure that the products conform to the identified essential requirements.










—


Quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, must be suitable to ensure the fulfilment of the applicable essential requirements.




5.1.7.   
Overview of modules








Modules


Description




A
Internal production control


Covers both design and production.
The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination).




A1
Internal production control plus supervised product testing


Covers both design and production.
A + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer.




A2
Internal production control plus supervised product checks at random intervals


Covers both design and production.
A + product checks at random intervals carried out by a notified body or in-house accredited body.




B
EU-type examination


Covers design.
It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated.
A notified body examines the technical design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type.




C
Conformity to EU-type based on internal production control


Covers production and follows module B.
Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.




C1
Conformity to EU-type based on internal production control plus supervised product testing


Covers production and follows module B.
Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.
C + tests on specific aspects of the product carried out by an in-house accredited body or under the responsibility of a notified body chosen by the manufacturer (*1).




C2
Conformity to EU-type based on internal production control plus supervised product checks at random intervals


Covers production and follows module B.
Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B.
C + product checks at random intervals tests on specific aspects of the product carried out by a notified body or in-house accredited body.




D
Conformity to EU-type based on quality assurance of the production process


Covers production and follows module B.
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU-type. The notified body assesses the quality system.




D1
Quality assurance of the production process


Covers both design and production.
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system.




E
Conformity to EU-type based on product quality assurance


Covers production and follows module B.
The manufacturer operates a product quality (=production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system.
The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process.




E1
Quality assurance of final product
inspection and testing


Covers both design and production.
The manufacturer operates a product quality (=production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to the legislative requirements (no module B (EU-type), used like E without module B). The notified body assesses the quality system.
The idea behind module E1 is similar to the one under module D1: both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final product, while the quality system under module D1 aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process.




F
Conformity to EU-type based on product verification


Covers production and follows module B.
The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type.
Module F is like C2 but the notified body carries out more systematic product checks.




F1
Conformity based on product verification


Covers both design and production.
The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to the legislative requirements (no EU-type, used like F without module B)
Module F1 is like A2 but the notified body carries out more detailed product checks.




G
Conformity based on unit verification


Covers both design and production.
The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type).




H
Conformity based on full quality assurance


Covers both design and production.
The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system.




H1
Conformity based on full quality assurance plus design examination


Covers both design and production.
The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system and the product design and issues an EU design examination certificate.
Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design.
The EU-design examination certificate must not be confused with the EU-type examination certificate of module B that attests the conformity of a specimen ‘representative of the production envisaged’, so that the conformity of the products may be checked against this specimen. Under EU design examination certificate of module H1, there is no such specimen. EU design examination certificate attests that the conformity of the design of the product has been checked and certified by a notified body.




5.1.8.   
Overview of procedures


The following procedures are possible:






—


A - Internal production control










—


A1 - Internal production control plus supervised product testing










—


A2 - Internal production control plus supervised product checks at random intervals










—


B+C - EU-type examination (B) followed by Conformity to EU-type based on internal production control (C)










—


B+C1- EU-type examination (B) followed by Conformity to EU-type based on internal production control plus supervised product testing (C1)










—


B+C2 - EU-type examination (B) followed by Conformity to EU-type based on internal production control plus supervised product checks at random intervals (C2)










—


B+D - EU-type examination (B) followed by Conformity to EU-type based on quality assurance of the production process (D)










—


D1 - Quality assurance of the production process.










—


B+E - EU-type examination (B) followed by Conformity to EU-type based on product quality assurance (E)










—


E1 - Quality assurance of final product inspection and testing










—


B+F - EU-type examination (B) followed by Conformity to EU-type based on product verification (F)










—


F1 - Conformity based on product verification










—


G - Conformity based on unit verification










—


H - Conformity based on full quality assurance










—


H1 - Conformity based on full quality assurance plus design examination









5.1.9.   
Rationale for selecting the appropriate modules













—



The legislator should avoid modules too onerous for the objectives of the Union harmonisation legislation concerned, without however compromising the protection of the public interest.











—



The complexity of the modules selected should be proportional to the risk (impact on public interest, health, safety, environment) of the product, its design complexity, the nature of its production (large series vs small series, custom-made, simple vs complex production mechanism etc.).









The legislator when selecting modules for his legislative instrument should follow the following principles:






—


As a general rule, products are subject to both design and production modules before placed on the market.










—


When appropriate in terms of protection of public interest, the manufacturer must be given as wide a choice of modules as possible.










—


If it is sufficient that the manufacturer carries out himself all checks in order to ensure the conformity of the products, then the legislator may select module A. This can be the case of low complexity (simple design and production mechanism) products that present a low risk for the public interest.










—


In cases of mass production based on a type/specimen and where the product in question is of complex design or presents higher risks of non-compliance for instance, the EU legislation may lay down the conformity assessment procedure in two steps: first the examination of conformity of the prototype/specimen against the relevant legal requirements (EU-type examination - module B) and then the determination of the conformity of the products against the approved EU-type (modules C and variants, D, E, F).










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In cases where the legislator has opted for the demonstration of conformity assessment against a specimen (module B), he must examine the possibility of whether it is sufficient that the manufacturer can carry out himself all checks in order to ensure the conformity in the production phase. If this is the case, then the legislator may select module C.










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In many cases the legislator must acknowledge that quite often, manufacturers manage very well equipped testing laboratories or premises. This is usually the case for new innovative complex products for which the testing know-how remains inside the manufacturers. In such cases the legislator may consider selecting either modules A1, A2, or, C1, C2 (the latter two, if he has opted for the demonstration of conformity assessment against a specimen - module B) that allow the use of an accredited in-house body.










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If the demonstration of conformity of products against an approved EU-type cannot be left to the manufacturer but requires that products are supervised by a notified body during the production process, then the legislator may require from the manufacturer either to operate an approved quality system (modules D, E) or that the conformity of his products are verified be means of tests/checks (module F). In this respect, if the production mechanism is relatively ‘simple’ then the legislator may consider that it sufficient that the quality system of the manufacturer focuses only on the test of the final product without including the pure manufacturing part. If this is the case, module E is the most appropriate.










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In the case of products of simple design but complicated production/manufacturing, the legislator may consider selecting modules D1, E1, F1 and using thus the advantages of modules D, E and F respectively, without the necessity of recurring to a more formal specimen examination (as provided under module B that precedes modules D, E, F).










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For products, produced in small series the legislator may consider selecting module G.










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If the manufacturer operates or has to operate a full quality system covering both the design and the production phase, the legislator may opt for module H.










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When the manufacturer operates a full quality assurance system, but the verification of the conformity of design and the issuance of EU design examination certificate by a notified body is necessary, then the legislator may select module H1.




5.2.   Conformity assessment bodies

5.2.1.   
Conformity assessment bodies and notified bodies








Notified bodies carry out the tasks pertaining to the conformity assessment procedures referred to in the applicable technical harmonisation legislation when a third party is required.





A conformity assessment body is a body that performs one or several elements of conformity assessment, including one or several of the following activities: calibration, testing, certification and inspection. Notified bodies are conformity assessment bodies which have been officially designated and notified by their national authority to carry out the procedures for conformity assessment within the meaning of applicable Union harmonisation legislation when a third party is required. They are called ‘notified bodies’ under EU legislation.
Notified bodies take responsibilities in areas of public interest and, therefore, must remain accountable to the competent national authorities. To be eligible a body must be a legal entity established on the territory of a Member State and, thus, come under its jurisdiction. Member States remain free to decide whether or not to notify a body which complies with the requirements laid down in the relevant Union harmonisation legislation.
5.2.2.   
Roles and responsibilities













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Notified bodies are free to offer their conformity assessment services, within their scope of notification, to any economic operator established either inside or outside the Union. They may carry out these activities also on the territory of other Member States or of third countries.











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Notified bodies must provide relevant information to their notifying authority, the market surveillance authorities and other notified bodies.











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Notified bodies must operate in a competent, non-discriminatory, transparent, neutral, independent and impartial manner.











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Notified bodies must have at their disposal the necessary personnel, who have sufficient and relevant knowledge and experience to carry out conformity assessment in accordance with Union harmonisation legislation in question.











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Notified bodies must make adequate arrangements to ensure confidentiality of the information obtained in the course of conformity assessment.











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Notified bodies must be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying Member State.











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Notified bodies may demonstrate their competence through accreditation, which is the preferred way to assess their technical competence.









Although the notified body must be established on the territory of the notifying Member State, it may have activities or personnel outside the Member State, or even outside the Union. Certificates and other conformity assessment attestations are, however, always issued by and in the name of the notified body (246). Since the notified body always has to carry out its assessment functions within the jurisdiction of the designating Member State, it has to inform the notifying authority, which must be capable of ensuring the monitoring of the total body as it has to take the responsibility for its operations. If monitoring is not considered possible, the notifying authority should withdraw or limit the scope of the notification as deemed necessary.
Notified bodies must keep their national notifying authorities informed of their activities (for example concerning the conduct of conformity assessments, availability of resources, subcontracting, situations of conflicts of interest), either directly or via an authorised body (for example the national accreditation body). They must also be prepared to provide either at the request of their notifying authorities or of the Commission, all information concerning the proper implementation of the conditions under which they were notified.
Notified bodies have a general obligation to inform the notifying authority about all certificates refused, restricted, suspended or withdrawn due to safety related non-conformities and, on request, about certificates issued or other conformity assessment activities performed. In addition, notified bodies must provide other bodies notified under the same Union harmonisation legislation, carrying out similar conformity assessment activities covering the same products, with relevant information on issues relating to negative and, on request, positive conformity assessment results. Given the confidentiality requirements that notified bodies have to observe when fulfilling their tasks, the information to be shared with other notified bodies cannot concern confidential commercial information on the product. Relevant information to be exchanged on issues relating to negative conformity assessment results should thus primarily concern the refusal to issue a conformity assessment attestation identifying the product and manufacturer in question.
They must also provide the market surveillance authority and, according to some Union harmonisation legislation also the market surveillance authorities of other Member States, with relevant information for the purpose of market surveillance. Notified bodies as such are not responsible for providing the EU Declaration of Conformity or the technical documentation. Having said that, in line with the applicable conformity assessment procedure, they might have to keep the technical documentation as part of the technical file and provide it to the Commission or the Member States upon request (247). Further, notified bodies must provide, on request of the Commission department responsible for administering a safeguard clause, the necessary information related to the product or the conformity assessment.
Notified bodies are and must remain third parties independent of their clients and other interested parties. The legal status of bodies seeking notification, whether they are private or state-owned, is irrelevant as long as their independence, impartiality and integrity are ensured, and they are identifiable as a legal entity bearing rights and obligations.
The requirement for independence covers the whole organisation, including the board of directors, and applies also for bodies belonging to business associations or professional federations.
In order to guarantee impartiality, the notified body and its staff have to be free from any commercial, financial and other pressure that might influence their judgement. The body also has to implement procedures to ensure that its work cannot be influenced from outside. The structure of the body must safeguard its impartiality, especially if the body has activities other than those of a notified body.
Furthermore, the body must have policies and procedures that distinguish between the tasks it carries out as a notified body and any other activity in which it is engaged, and it must make this distinction clear to its customers. Accordingly, marketing material must not give any impression that assessment or other activities carried out by the body are linked with tasks described in the applicable Union harmonisation legislation.
When a conformity assessment body delivers a test report it is in its capacity as a conformity assessment body; only in its capacity as notified body can it deliver EU-type examination certificates – a certificate bearing in particular the name and identification number of the notified body. In no circumstances must the notified body issue a test report carrying its notified body number (248) in relation to tests that are not specified in the legislation, whether those tests were carried out by the body itself or by another body. Moreover, a notified body may only use its number in relation to conformity assessment activities carried out under the specific conformity assessment module that requires the intervention of a notified body, and for which it has been notified.
Accredited Notified Bodies should act as such and always mention in the certificates they issue the fact that they are accredited, where the activity is covered by the accreditation certificate.
A notified body must require the manufacturer to take appropriate corrective measure and, if necessary suspend or withdraw a certificate it has issued, if in the course of the monitoring of conformity following the issue of the certificate, it finds that the product no longer complies (249).
In their capacity of notified bodies, they must not offer or provide additional services unless they have an added value for the conformity assessment of the product. However, notified bodies may offer any type of conformity assessment services and markings where the products are intended for the markets of third countries outside the European Union, for example in the context of Mutual Recognition Agreements (250). Such activities must be clearly separated from the activities of the body as a notified body. Notified bodies must also ensure that their activities outside the scope of technical harmonisation legislation do not compromise or diminish confidence in their competence, objectivity, impartiality or operational integrity as notified bodies. Notified bodies cannot use their notified body number to carry out these activities. Notified bodies should particularly refrain from issuing certificates under their Notified Body number for the purposes of other Union harmonisation legislation than the one for which they are notified and which also require the intervention of a notified body.
A notified body may not be the manufacturer, the authorised representative, a supplier or their commercial competitor, nor offer or provide (or have offered or provided) consultancy or advice to any of these parties as regards the design, construction, marketing or maintenance of the products in question. However, this does not preclude the possibility of exchanging technical information and guidance between the manufacturer, the authorised representative, suppliers and the notified body.
To safeguard impartiality and avoid conflicts of interest it is important to make a clear distinction between conformity assessment performed by notified bodies prior to placing products on the market and market surveillance. Furthermore, market surveillance authorities must carry out their duties independently, impartially and without bias. Therefore, it is to be considered as inappropriate for market surveillance authorities to be designated as notified bodies, and the necessary safeguards should be put in place to ensure the impartiality and absence of conflict of interest if a single entity is entrusted with both responsibilities (251) (252). Notified bodies must have documented procedures for the identification, review and resolution of all cases where conflict of interest is suspected or proven. The notified body should also require all staff acting on its behalf to declare any potential conflict of interest.
Notified bodies must have under their control the necessary personnel, who have sufficient knowledge and experience relating to the products and conformity assessment procedure in question, and who have appropriate training. In particular, knowledge and experience should relate to relevant regulatory requirements and enforcement policies, European and international standardisation activities, relevant technologies, production methods and verification procedures, and normal conditions of use of the product in question. The body must be in a position to manage, control and be responsible for the performance of all its resources and maintain comprehensive records concerning the suitability of all the staff it uses in particular areas, whether they are employees, employed on contract or provided by external bodies. The body must also have access to appropriate facilities and be able to test or re-test in the EU. Otherwise it will not be possible for the notifying authority to check its competence.
Notified bodies must ensure the confidentiality of all the information it obtains in the course of conformity assessment. It must make adequate arrangements to ensure that no results or other information is disclosed to any other party than the competent authority in question, and to the manufacturer or the authorised representative.
Notified bodies must have adequate insurance to cover their conformity assessment activities. The scope and overall financial value of liability insurance must correspond to the level of risk linked with the activities of the notified body. The manufacturer in particular retains, however, the overall responsibility for the conformity of the product with all the requirements of the applicable legislation, even if some stages of the conformity assessment are carried out under the responsibility of a notified body.
Notified bodies are obliged to participate in coordination activities (253). They must also take part directly or be represented in European standardisation, or otherwise ensure that they know the situation of relevant standards (254).
5.2.3.   
Competence of notified bodies



The primary task of a notified body is to provide conformity assessment services on the conditions set out in the applicable Union harmonisation legislation. This is a service to the manufacturers in an area of public interest.

Notified bodies are designated to assess conformity with the essential requirements, and to ensure consistent technical application of these requirements according to the relevant procedures in the applicable Union harmonisation legislation. The notified bodies must have appropriate facilities and technical staff that enable them to carry out technical and administrative tasks related to conformity assessment. They must also apply appropriate procedures of quality control in relation to such services provided. Manufacturers are free to choose any notified body that has been designated to carry out the conformity assessment procedure in question according to the applicable Union harmonisation legislation.
Some sectoral legislation provides for the application of a conformity assessment module that provides for the mandatory involvement of a notified body (e.g. EU-type examination) in cases where harmonised standards do not exist or are not applied by the manufacturer. Consequently, in order to ensure a correct implementation of the internal market rules, Notified Bodies are required to be able to demonstrate that they have the competences to perform the required conformity assessment and to issue the required attestation to certify that the regulatory requirements have been fulfilled, also in the (complete) absence of harmonised standards.
A notified body wishing to offer services according to several conformity assessment procedures must fulfil the relevant requirements for the respective tasks, and this has to be assessed according to the requirements for each different procedure in question. However, since the scope of much technical harmonisation legislation can be relatively wide and heterogeneous, a notified body does not need to be qualified to cover all products falling within the scope of that legislation, but may be notified for a defined range of products only.
Notified bodies must have appropriate structures and procedures to ensure that the conduct of conformity assessment and the issuing of certificates are subject to a review process. Relevant procedures must, in particular, cover obligations and responsibilities in relation to suspension and withdrawal of certificates, requests addressed to the manufacturer to take corrective measures, and reporting to the competent authority.
Apart from carrying out certain responsibilities in the field of public interest, notified bodies must regard themselves as rendering services to industry. Thus, they should provide relevant information to the manufacturer and the authorised representative regarding the legislation in question, apply the conformity assessment procedure without unnecessary burdens for the economic operators, and refrain from proposing additional certification or marking that has no added value for the conformity assessment of the product. The latter activities must be clearly separated from the activities of the body as a notified body. Notified bodies cannot use their notified body number to carry out these activities.
To avoid unnecessary burdens for economic operators and help in ensuring the protection of confidential data or intellectual property rights, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessing conformity to the legislation.
The manufacturer can provide test reports or other elements of its technical documentation. The notified body can take these reports into account if it assumes full responsibility for the results. The notified body may accept the manufacturer’s test results for the conformity assessment provided that it justifies the reason for taking account of these tests. However, accepting the results of the manufacturer’s tests is not as such sufficient to fulfil its tasks as notified bodies and additional tests will have to be performed under the applicable module by the Notified Body.
5.2.4.   
Coordination between notified bodies


In recognition of the fact that notified bodies fulfil tasks delegated to them by public authorities, they are obliged to take part in coordination activities organised by the Commission. The latter, together with the Member States, ensures that coordination is organised between the notified bodies.
A coordination group of notified bodies is established for each Union harmonisation legislative act or for several related acts, and its work is limited to technical problems relating to conformity assessment in order to ensure a uniform application of the technical provisions of the applicable legislation. To that end, it should be free to define its rules of work and constitution. Each group of notified bodies has a technical secretariat and a chairperson.
Generally, the groups of notified bodies are composed of representatives of notified bodies only. The Commission may provide financial support to the Secretariats, so to mitigate costs and remove barriers to the participation (255). To achieve a higher degree of efficiency in their work the groups can set up subgroups with a restricted number of participants to discuss specific technical questions. The Commission is represented in the groups. Governmental experts and representatives of the authorities directly responsible for the effective implementation of Union harmonisation legislation can participate as observers in the groups. The European standardisation organisations (CEN, CENELEC and ETSI) are represented in the groups when standards related issues arise. Where cases relating to harmonised standards are discussed, with significant doubts on the presumption of conformity given by the standards, the group of the Notified Bodies is expected to inform the Commission and the Member States. The groups may also invite relevant European federations and other interested parties. Where the groups of notified bodies have to treat subjects of a confidential nature, the participation in meetings is restricted as deemed necessary. The recommendations and administrative decisions taken by the groups of notified bodies should be limited to the common understanding of technical aspects of conformity assessment including, if needed, clarifications for a common understanding of specific parts of applicable harmonised standards, and not concern the interpretation of the relevant legislation. It is appropriate that the groups of notified bodies publish their administrative decisions and recommendations. If a body refuses to cooperate, the notification may be withdrawn. However, the notified bodies are not obliged to participate in meetings at European level if they keep themselves informed of, and apply the administrative decisions and documents produced by their group. The relevant working documents, meeting reports, recommendations and guidelines produced by the sectoral and inter-sectoral groups of notified bodies or their subgroups should be made available to all notified bodies forming part of those groups, whether they have taken part in the meetings or not. The information exchange and communication can be enhanced by use of a platform such as CIRCABC, hosted by the Commission.
National coordination groups are also encouraged and where those exist, notified bodies from a given Member State might be required to take part in their activities.
5.2.5.   
Subcontracting by notified bodies













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A notified body can have part of its work carried out by another body, whether a subcontractor or a subsidiary, on the basis of established and regularly monitored competence.











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Subcontracting must be based on a contract, which makes it possible to ensure the transparency of and have confidence in the notified body’s operations.









A notified body can only subcontract a task for which it has the competence itself. It must not be the case that a notified body subcontracts a part of the work because it does not have the required competence and knowledge. A notified body must have appropriate personnel and equipment and be able to carry out all necessary tests and evaluations according to the requirements of the modules itself.
The bodies acting as subcontractors for the notified bodies need not be notified as such. Nevertheless, the notified body must inform the Member State concerned of its intention to subcontract certain work. The extent to which the notified body intends to rely on subcontractors (including outside the EU) or have access to personnel or facilities outside the Member State of notification must be appropriately assessed by the notifying authority. The Member State may decide that it cannot take the overall responsibility as a notifying authority for such an arrangement, and withdraw or limit the scope of the notification. The notified body must keep a register of all its subcontracting activities, and update it systematically. Conformity assessment activities that are not subcontracted should be performed on the premises of the notified body or on the premises of the manufacturer, as indicated in the applicable conformity assessment module.
The body subcontracted by the notified body must be technically competent, and display independence and objectivity according to the same criteria and under the same conditions as the notified body. The Member State that has notified the body which subcontracts part of its work must be capable of ensuring effective monitoring of the competence of the body subcontracted by the notified body. Individual external auditors or specialists have to fulfil the conditions of a subcontractor.
The notified body must ensure that its subcontractors have the necessary competence and that they maintain this competence, for example by carrying out regular evaluations and by keeping itself regularly informed of the details regarding the performance of their tasks. The notified body must also be able to demonstrate the compliance of its subcontractors with the requirements laid down in the relevant Union harmonisation legislation.
Information on subcontracting activities and on the competence of the subcontractors and/or the subsidiaries must be readily available at all times, so that the notifying authority can take any necessary action, and communicate it without delay to the Commission and the other Member States on request. Compliance with the EN ISO/IEC 17000 series of standards entails a presumption of conformity of the subcontractor with most of the requirements, as is the case with the notified body itself. Where accreditation is not used to assess the competence of notified bodies, the authority should undertake on-site checks of the subcontractor to the same extent as would be provided for under accreditation.
A further condition for subcontracting is that the conformity assessment procedure can be subdivided into technical operations and assessment operations, and that the methodology used to carry out the technical operations is sufficiently precise. A notified body can subcontract strictly limited technical tasks (such as tests and examinations), as long as these can be defined as substantial and coherent parts of the technical operation. The body subcontracted by the notified body must, nevertheless, carry out substantial and coherent parts of these technical operations. The notified body staff has to be technically qualified to be able to assess the test results of subcontractors. Notified bodies must not restrict their activities to purely administrative functions.
Notified bodies may, for example, subcontract tests while continuing to assess their results and, in particular, to validate the test report in order to evaluate whether the requirements of the Union harmonisation legislation are met. Similarly, subcontracting is possible in the field of certification of quality systems provided that the notified body carries out the evaluation of the audit results. The notified body cannot under any circumstances subcontract all of its activities, as that would make the notification meaningless.
Concerning the subsidiaries and subcontractors of a notified body, conflicts of interest may arise: a notified body cannot perform conformity assessment on items where e.g. a related (to the notified body) company (i.e. subsidiary or subcontractor) has been involved with the manufacturer by providing consultancy services or has participated directly or indirectly in the design, manufacturing, installation etc. of the product or type of product. To avoid such a conflict of interests the notified body should identify the risks coming from e.g. the services subsidiaries/subcontractors provided to companies for a specific product. The notified body should make this information available and state that if these companies provided services to a manufacturer for a specific product the notified body is unable to provide conformity assessment to that manufacturer for the concerned items.
The subcontracted work must be carried out according to pre-established technical specifications setting out a detailed procedure based on objective criteria to guarantee total transparency. Where the body subcontracted by the notified body is involved in the assessment of conformity to standards, these must be used if they lay down the procedures. If this body is involved in the assessment of conformity to essential requirements, the procedure followed by the notified body itself or a procedure deemed by the notified body to be equivalent to that must be used.
The notified body must in all cases have a binding agreement with its subcontractors to ensure that its general responsibilities are fulfilled (256). Notified bodies must keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under the relevant Union harmonisation legislation (257).
A subcontracting notified body remains responsible for all the activities covered by the notification. Subcontracting does not entail the delegation of powers or responsibilities. Certificates and other attestations of conformity are always issued in the name and under the responsibility of the notified body. Therefore, the subcontracting notified body must be competent to review the work of the subcontractor in all its elements and must take the final decision.
The conditions for subcontracting apply to any subcontractor whether or not established within the European Union. The notified body remains entirely responsible for the work carried out for it by the subcontractor.
The notified body must have appropriate facilities and staff to be able to verify the results of any tests, inspections or any other task carried out by the subcontractor. Furthermore, if accreditation is the chosen path for notification, it must cover the subsidiary companies of notified bodies to which they have recourse. Accreditation bodies must take this into account, either by properly applying the existing international guidance on cross-frontier accreditation or by specifying it in the accreditation documents. If notification is not based on accreditation, then in order to ensure the proper and consistent supervision of such subsidiaries and subcontractors, the contents of the information to be provided to the notifying authority should be further specified by aligning it to the relevant practices in accreditation.
5.2.6.   
Accredited in-house bodies
 (258)

Only in the cases where sectoral Union harmonisation legislation provides for it, an accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part, for the implementation of the conformity assessment procedures, modules A1, A2, C1 or C2. That body must constitute a separate and distinct part of the undertaking and must not participate in the design, production, supply, installation, use or maintenance of the products it assesses.
An accredited in-house body has to meet a number of requirements. It must be accredited in accordance with Regulation (EC) No 765/2008. The body and its personnel must be identifiable within the structure of the organisation, and have reporting methods within the undertaking of which they form a part which ensure their impartiality and demonstrate it to the relevant national accreditation body. Neither the body nor its personnel may be responsible for the design, manufacture, supply, installation, operation or maintenance of the products they assess, nor may they engage in any activity that might conflict with their independence of judgment or integrity in relation to their assessment activities. An accredited in-house body can supply its services only to the undertaking of which it forms a part.
An accredited in-house body cannot be notified to the Member States or the Commission, but information concerning its accreditation must be given by the undertaking of which it forms a part, or by the national accreditation body, to the notifying authority at the request of that authority.
5.3.   Notification

5.3.1.   
Notifying authorities








A notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodies under Union harmonisation legislation.





A notifying authority is the governmental or public body that is tasked with designating and notifying conformity assessment bodies under Union harmonisation legislation. Most often it is the national administration responsible for the implementation and management of the Union harmonisation act under which the body is notified. Each Member State must designate a notifying authority to be responsible for the assessment, notification and monitoring of conformity assessment bodies. The notifying authority assumes full responsibility for the competence of the bodies it notifies.
Each Member State must establish its notifying authorities in such a way that there is no conflict of interest with conformity assessment bodies. They must be organised and operated so as to safeguard the objectivity and impartiality of their activities. Each decision relating to notification of a conformity assessment body must be taken by competent persons different from those who carried out the assessment.
Further requirements on a notifying authority are that it must not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis. It must safeguard the confidentiality of the information it obtains, and it must have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Member States must inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies. The Commission makes that information publicly available on its web site.
5.3.2.   
Notification process













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Notification is the act of the notifying authority informing the Commission and the other Member States that a conformity assessment body has been designated to carry out conformity assessment according to a Union harmonisation act, and fulfils the requirements relating to notified bodies set out in that Union harmonisation act.











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Member States take the final responsibility for the competence of their notified bodies with respect to the other Member States and the EU institutions.











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Accreditation is the preferred way to assess the technical competence of notified bodies.











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The notification of a notified body is sent by the notifying authority to the Commission and the other Member States via NANDO - the electronic notification tool developed and managed by the Commission where a list of all notified bodies can be found.









5.3.2.1.   Principles of notification

The status of Notified Body is available to conformity assessment bodies established within the European Union. Member States are responsible for the notification of notified bodies and the choice of and responsibility for notified bodies rests with national authorities. They may choose the bodies they notify from those that are established on their territory which comply with the requirements of the legislation, and which have the necessary competences to become notified. Notification is the act of the notifying authority informing the Commission and the other Member States that such a body has been designated to carry out conformity assessment according to a Union harmonisation act, and fulfils the requirements relating to notified bodies set out in that Union harmonisation act.
While designation is considered as an act of the designating authority – which may be the same body as the notifying authority – only the act of notifying the Commission and the other Member States allows a ‘designated body’ to become a ‘notified body’.
Since notification falls within the discretion of Member States, they are not obliged to notify all the bodies demonstrating technical competence. Neither are Member States obliged to notify bodies in respect of each procedure to be applied according to a specific Union harmonisation act.
Member States are free to notify a body at any time after a Union harmonisation act has been adopted. They should nevertheless take all necessary steps for notifying before the Union harmonisation act starts applying (259) and ensure harmonised competences across all notified bodies. This can make effective use of the transitional period provided for in the Union harmonisation act, and allow for notified bodies to be active and certificates to be granted from the date of first application of the Union harmonisation act. If on the basis of new legislation the re-notification of notified bodies is required, as soon as the Member State has transposed the necessary provisions into national law and has appointed a notifying authority for a particular Union harmonisation act, it is possible for that notifying authority to place a notification. A notified body may thus be notified under both the old and the new legislation during the transitional period, but the notification under the old legislation will expire automatically on the date of application of the new legislation, unless specific legislation provides otherwise. It must be stressed, however, that in such cases notified bodies, while they can do preparatory work, are not entitled to issue certificates before the Union harmonisation legislation starts applying unless sector legislation provides otherwise.
5.3.2.2.   Assessment of conformity assessment bodies

The assessment of a conformity assessment body seeking notification determines if it is technically competent and capable of carrying out the conformity assessment procedures in question, and if it can demonstrate the necessary level of independence, impartiality and integrity.
Member States take the final responsibility for the competence of their notified bodies with respect to the other Member States and the EU institutions. They must therefore verify the competence of the bodies seeking notification, based on the criteria laid down in the applicable Union harmonisation legislation in conjunction with essential requirements and the conformity assessment procedure(s) in question. In general, the competence criteria set out in the Union harmonisation acts cover:






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availability of personnel and equipment;










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independence and impartiality in relation to those directly or indirectly concerned with the product (such as the designer, the manufacturer, the manufacturer’s authorised representative, the supplier, the assembler, the installer, the user);










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technical competence of personnel that is relevant to the products and conformity assessment procedure in question;










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maintenance of professional secrecy and integrity; and










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subscription to civil liability insurance, unless that liability is covered by the state under national law.




Notifying authorities or accreditation bodies must carry out periodic monitoring to assess the continuity of the competence of notified bodies after they are notified.
Notified Bodies may have activities or personnel outside the Member State where they are legally established, or even outside the Union. However, the notifying authority of this Member State must be capable of ensuring the monitoring of the whole Notified Body (not only the head office). Having all the testing facilities in another Member State or even outside the EU would make it almost impossible for the notifying authority to monitor the operations of the whole Notified Body.
The supervision of multi-site conformity assessment bodies is done under the cross-border cooperation among the national accreditation bodies and notifying authorities; however, the responsibility remains with the notifying authority of the Member State in which the conformity assessment body is established. The conformity assessment body as the main entity to be notified must have itself the means and the competence to carry out the tasks required for the notification. While it may have recourse to subsidiaries/subcontracting, it should not rely for all test and evaluations on subsidiaries/subcontractors (260).
The notified body may subcontract specific tasks connected with the conformity assessment, has to ensure that the subcontractor meets the same requirements that are applicable to the notified body itself and may subcontract specific activities only with the agreement of the client. Thus, structures where the head office of the candidate-notified body in the Member State of notification consists of very few staff performing only commercial tasks but none of the conformity assessment tasks for which the body is (to be) notified would be carried out in that Member State, cannot be accepted.
5.3.2.3.   Accreditation under Regulation (EC) No 765/2008

Accreditation, performed according to the EN ISO/IEC 17000 series of standards by nationally recognised accreditation bodies that are members of the European co-operation for Accreditation (EA), is a technical assessment of the competence of the conformity assessment body seeking notification. Although it is not a requirement, it remains an important and favoured instrument for evaluating the competence and integrity of the bodies to be notified. For this reason, accreditation should be considered by national notifying authorities as the most favoured technical basis for the assessment of conformity assessment bodies so as to reduce differences in the criteria applied for notification.
The harmonised standards of the EN ISO/IEC 17000 series that can be used to demonstrate the competence of the candidate notified body may vary depending on the specific conformity assessment tasks (modules) and the different products in Union harmonisation legislation. In order to ensure harmonisation of the assessment of competence of candidate notified bodies, the European Cooperation for Accreditation (EA) has developed a recommendation on standards for accreditation for each relevant Union harmonisation legislation and for each conformity assessment module (261). It is intended to apply to all National Accreditation Bodies that assess and accredit conformity assessment bodies for notification purposes, unless the notifying and/or regulating authority - at its own discretion - has officially established and published different requirements.
Accreditation provides an authoritative statement of the competence, professional integrity and impartiality of the bodies to be notified to the Commission and the other Member States. For a notification to be considered as accompanied by an accreditation certificate, the accreditation certificate must indicate the competence of the candidate notified in relation to the specific Union harmonisation legislation for which notification is being sought. Accreditation also entails regular monitoring and surveillance of the accredited bodies. Whenever a national accreditation body ascertains that the conformity assessment body to which it has issued an accreditation certificate is no longer competent or does not fulfil its obligations, the accreditation certificate must be withdrawn. In this case the body should be de-notified and no longer allowed to carry out conformity assessment activities under the relevant legislation.
The preference given to accreditation is based on the peer evaluation process which ensures that the accreditation body adequately supervises the conformity assessment bodies it accredits. Cases may, however arise where the national accreditation body has not been successfully peer evaluated but may nevertheless have assessed notified bodies (262). If the national accreditation body has not been peer evaluated for the specific accreditation activity in question but still evaluate the competence of a conformity assessment body for this activity, the notification of this conformity assessment body should not be considered as accredited for the purposes of EU harmonisation legislation.
If a national accreditation body was successful in a previous peer evaluation for a given activity but has been suspended at a subsequent peer evaluation, new notifications of conformity assessment bodies assessed by this national accreditation body should also be considered as unaccredited. As a principle, accreditation certificates issued up until the point of the suspension of the peer evaluation of the national accreditation body, should continue to be recognised by national authorities.
If the grounds for suspension of the national accreditation body result in serious doubts about the competence of the notified bodies, the responsible notifying authority would have to inform the Commission and other Member States of how it intends to ensure the competence of the bodies notified, and of any corrective measures taken, including the de-notification.
Although accreditation is the favoured instrument for the verification of competence of conformity assessment bodies, Member States can carry out the evaluation themselves. Following the entry into force of Regulation (EC) No 765/2008 on 1 January 2010, in such cases evidence must be given to the Commission and other Member States that the evaluated body complies with all the applicable regulatory requirements. Further, the notified body must be subject to regular surveillance similar to the practice established by the accreditation organisations.
5.3.2.4.   Article 5(2) of Regulation (EC) No 765/2008

According to Article 5(2) of Regulation (EC) No 765/2008, when a Member State does not base its notification on accreditation, ‘it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Union harmonisation legislation in question’ (263).
In order to ensure the necessary level of confidence in the impartiality and technical competence of conformity assessment bodies and in the reports and certificates issued by them, national authorities, when carrying out the assessment without accreditation, should give detailed and comprehensive information describing how the candidate Notified Body has been assessed as qualified to carry out the tasks for which it is notified and showing that it fulfils the applicable criteria relating to notified bodies. This information, linked to a given notification, is made available to the Commission and the other Member States using the NANDO electronic notification tool.
The evaluation procedure should be based on at least the following elements:






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a formal application procedure










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assessment against applicable requirements.










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production of an assessment report










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clear decision-making process










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existence of a systematic surveillance and related sanction mechanism, providing for periodic surveillance including on-site visits, in order to verify the continued fulfilment of requirements by the notified body










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demonstration of the national authority’s own technical competence for assessing conformity assessment bodies for the purpose of notification under technical harmonisation legislation. This demonstration must give equivalent assurance as the EA (264) peer evaluation system.










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the candidate notified bodies should be made aware of general conditions, of their rights and obligations, and of the requirements relating to assessment carried out with a view to notification




The assessment itself should consist of:






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a review of documents verifying the completeness and appropriateness from a substantial point of view with regard to conformity to the applicable requirements










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an on-site audit to check technical and procedural aspects - such as the availability and appropriateness of facilities and equipment, the technical competence of staff, the existence of an appropriate management system - and to check other aspects demonstrating that conformity to requirements is properly implemented. The assessment must include witnessing technical activities.




When choosing an assessment process other than formal accreditation, notifying authorities must indicate the reasons why accreditation is not chosen to back up the notification process. Moreover, notifying authorities may not outsource to the national accreditation body the assessment of unaccredited conformity assessment bodies that seek to become notified bodies, without fulfilling the whole accreditation process including the delivery of the accreditation certificate.
When accreditation is not used, the notifying authorities must perform periodical verifications to ensure the continuous competence of the notified body, in the same way as national accreditation bodies do.
5.3.2.5.   Steps in the notification of a notified body

To obtain notification, a conformity assessment body submits an application for notification to the notifying authority of the Member State in which it is established. That application should be accompanied by a description of the conformity assessment activities, the conformity assessment procedures or modules and the product or products for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by the national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in the relevant harmonisation legislation.
Where the body concerned cannot provide an accreditation certificate, it must provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in the relevant harmonisation legislation. After verification the Member State informs the Commission and the other Member States of the details of the body.
The notification of a notified body is sent by the notifying authority to the Commission and the other Member States via NANDO (New Approach Notified and Designated Organisations), which is an electronic notification tool developed and managed by the Commission. It should include full details of the body, its conformity assessment activities, the conformity assessment procedures or modules and product or products concerned, and the relevant attestation of competence. It must also include the date set for the reassessment of the notified body by the national accreditation body or, for an unaccredited notification, the date of the next monitoring review by the notifying authority.
Where a notification is not based on an accreditation certificate, the notifying authority must provide the Commission and the other Member States with documentary evidence which demonstrates the conformity assessment body’s competence, how it has been assessed, and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements.
The notification takes effect after a notification email from NANDO has been sent to the Commission and the other Member States and published on the NANDO web site. The body concerned may then perform the activities of a notified body. Under legislation that is aligned with Decision No 768/2008/EC, the notification is published following a period allowed for objections by other Member States or the Commission - two weeks where accreditation is used, two months where accreditation is not used - and then only where no such objections have been raised.
The Commission and the other Member States must be notified in similar manner of any subsequent changes to the notification that are relevant, such as a change in the scope or validity period of the notification, or changes to the details of the body itself.
5.3.3.   
Publication by the Commission – the NANDO website


For information purposes, the Commission makes the lists of notified bodies (and other categories of conformity assessment bodies such as User Inspectorates and Recognised Third Party Organisations) publicly available on the NANDO web site on its Europa server. The lists are updated as and when the notifications are published, and the web site is refreshed daily to keep it up-to-date.
With its initial notification, a notified body is assigned an identity number in the NANDO system. This number is automatically generated by the system at the moment of validation of the notification in the NANDO database. A legal entity may carry only one notified body identity number, regardless of the number of Union harmonisation acts for which it is notified. Allocation of the number is a purely administrative act designed to ensure the consistent management of the lists of notified bodies, and does not confer rights or commit the Commission in any way. The numbering system in NANDO is sequential, and numbers are not re-used when a notified body is withdrawn from the list. In cases of suspension or withdrawal of a notification, the details of the notification remain in the database, and are moved to the ‘Withdrawn/Expired Notifications/NBs’ part of the web site (265).
Amendments (extension or reduction) to the scope, modifications of the validity period of the notification, or cancellation of the notification are likewise notified by email to the Member States and are published on the NANDO web site. The web site can be searched by Union harmonisation act, by country, by notified body number or using keywords.
5.3.4.   
Monitoring of the competence of notified bodies – Suspension – withdrawal – appeal


It is essential to ensure that notified bodies remain competent over time and that this can be made transparent to the other Member States and the Commission. Legislation at EU level clearly requires the national competent authorities to regularly monitor and assess the continuing competence of the bodies they have notified and that are listed in NANDO. The NANDO web site should be transparent for these ongoing processes that back up the notification system.
All notifications of notified bodies, whether accredited or unaccredited, that are entered in the NANDO database, should be updated within a maximum period of five years from the date of the initial notification, or the last update, with information on the continuous monitoring of the competence of the notified body. Such updates should include the relevant new data relating to accreditation or, if the notification is unaccredited, information relating to the required monitoring of the body by the notifying authority - in particular, a report concerning the assessment process i.e. document review, on-site assessment, description of systematic surveillance including on-site visits and demonstration of the authority’s technical competence to conduct the assessment. If the notification is not updated after the 5 year period, the Commission will consider that there is reason to question the continued competence of the notified body (266) and will request the notifying Member State to provide with all information relating to the maintenance of the competence of the body concerned.
The Commission and the Member States have the responsibility to act when doubt arises about the competence of a notified body, either at the moment of notification or thereafter. Should the Commission consider, on its own initiative or after complaint, that a notified body does not comply with the requirements or fulfil its responsibilities, it will inform the national notifying authority and ask for appropriate documented evidence concerning the basis for the notification and the maintenance of the competence of the body. Should a Member State not provide such information, the Commission may bring this to the attention of the other Member States for discussion or initiate the procedure under Article 258 TFEU against the notifying Member State.
Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in the relevant legislation, or that it is failing to fulfil its obligations, the notifying authority must - depending on the seriousness of the failure - suspend or withdraw the notification after immediately contacting the body in question. It has to immediately inform the Commission and the other Member States accordingly. The Member State must also have this information published, and inform the Commission and the other Member States following a procedure similar to that of the notification. The body in question should have the possibility to appeal against such a decision. Whether this appeal postpones the de-notification or not depends on national legislation.
Withdrawal of notification takes place when the notified body ceases to fulfil the requirements or its obligations. This may be done at the instigation of the notifying Member State, where it has received evidence regarding the failure of the notified body to meet its requirements during the periodic surveillance (done by the accreditation body or the notifying authority), or has received complaints about the notified body’s competence or behaviour. It may also be a result of action by the Commission, where the latter has reason to doubt that a notified body meets or continues to meet the requirements for its notification. In such cases the Commission informs the notifying Member State accordingly and requests it to take the necessary corrective measures, including de-notification if necessary. The notifying authority must take appropriate measures. Another reason for withdrawal of a notification might be the request of the notified body itself, for instance due to planned changes in policy, organisation or ownership of the body. Withdrawal of a notification can also be the end result of an infringement procedure.
Withdrawal is the responsibility of the notifying Member State. Only the national authority is entitled to withdraw a notification. The Commission can withdraw a notified body from the NANDO list only when, at the end of an infringement procedure under Article 258 TFEU, the Court of Justice of the European Union declares a Member State to be in infringement of a given Union harmonisation act and, consequently, declares a notification to be invalid. In all such cases the Commission will ensure that any sensitive information obtained in the course of its investigations is treated confidentially.
Without prejudice to sectoral specificities, the suspension or withdrawal of a notification does not affect certificates issued by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn. In order to ensure continuity in the event of the suspension or withdrawal of a notification, or where the notified body has ceased its activity, the notifying Member State must ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
6.   ACCREDITATION

Regulation (EC) No 765/2008 provides a legislative framework for accreditation at the national and EU levels and puts into place an overall policy with its rules, procedures and infrastructures. The reinforcement of accreditation as a means of underpinning the competence of conformity assessment bodies and hence the credibility and acceptance of certificates and other attestations, required to ensure the free movement of goods, has been a preoccupation of the Commission since the end of the 1970s. In the 1990s there was a trend towards accreditation becoming a commercial and competitive activity, hence reducing its credibility as the last level of control. The NLF however confirmed that in the EU, accreditation is a non-commercial and non-competitive public activity which is accountable to both national and European authorities.
The reinforced EU accreditation system thus put in place is in line with the standards, rules and practices of the international organisations in the field. Regulation (EC) No 765/2008 aims to ensure that accreditation serves the public interest. European Cooperation for Accreditation (EA), the European organisation of national accreditation bodies, is recognised by the Regulation, by the guidelines signed with the Member States (EFTA included) and the Commission on 1 April 2009, and benefits from a privileged relationship with the Commission through the signature of a Framework Partnership Agreement. Within this framework, the primary role of EA is to contribute to the harmonisation of European accreditation services to support the mutual recognition and acceptance of accreditation certificates throughout the Union, and to operate a rigorous peer evaluation system that controls the competence of the national accreditation bodies and the equivalence of their services.
In the field of accreditation, Regulation (EC) No 765/2008 has established a single European system which covers both the regulated domain where accreditation is required by legislation as well as for the non-regulated sphere. In the latter case, where a body voluntarily wishes to be accredited it can only go to the accreditation bodies which operate under Regulation (EC) No 765/2008, thus avoiding the existence of competing systems, whichever principles they may be based on. Therefore, the explanations below regarding accreditation cover also accreditation delivered in the voluntary area.
6.1.   Why accreditation?







Accreditation provides the last level of public control in a quality chain underpinning the free movement of goods in the Union.





Regulation (EC) No 765/2008 introduced a legal framework for accreditation for the first time. Accreditation of conformity assessment bodies had previously been used in both the regulated and non-regulated domains, but it was not governed by a legal framework at European level.
The idea of regulating accreditation at European level is twofold. On the one hand a comprehensive European framework for accreditation provides the last level of public control in the European conformity assessment chain and is therefore an important element in ensuring product conformity – on the other it enhances the free movement of products and services across the EU by underpinning trust in their safety and compliance with other issues of public interest protection.
Before the entry into force of the Regulation, the lack of common rules for accreditation across Member States meant that accreditation was being used very differently, with the result that accreditation certificates were not necessarily recognised by different national authorities and market operators - leading to multiple accreditation and therefore increased cost to business and conformity assessment bodies without producing the benefits described above.
Introducing the legal framework for accreditation therefore reduced administrative burdens in the single market and enhanced public control over accreditation so that it serves as an essential tool for the functioning of the internal market.
The accreditation framework set up by the Regulation explicitly applies both to the regulated and to the voluntary spheres. This is so, because the distinction between the two can become blurred as conformity assessment bodies are active, and products are used, in both fields. A differentiation would therefore lead to unnecessary burdens for public authorities and market actors while leading to contradictions between the voluntary and regulated domains.
6.2.   What is accreditation?







Accreditation is the attestation by a national accreditation body based on harmonised standards that a conformity assessment body has the technical competence to perform a specific conformity assessment activity.





Accreditation is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.
A wide range of products are subject to third party conformity assessment. This includes unregulated products as well as products regulated at national or at EU level. For products regulated at EU level i.e. in the harmonised area, this usually means that nationally designated conformity assessment bodies – notified bodies – test the product and issue an attestation of conformity before the product can be placed on the market.
More precisely, for there to be accreditation, there has to be an accreditable conformity assessment body (regardless of its legal personality) performing a specific conformity assessment activity.
Accreditation is the standards-based activity to ensure and attest that conformity assessment bodies have the technical competence to perform their duties as is required by the relevant regulations and standards. It assesses conformity assessment bodies’ competence to perform their duties in specific fields, as accreditation is always linked to a specific scope of activity of the conformity assessment body. Operating in the public interest, accreditation assesses the technical competence, reliability and integrity of conformity assessment bodies. It does this through a process of transparent and impartial evaluation against internationally recognised standards and other requirements. Regulation (EC) No 765/2008 obliges national accreditation bodies to verify that conformity assessments are carried out in an appropriate manner and that account is taken of the size and structure of undertakings and the degree of complexity of the product technology in question and the nature of the production process.
Accreditation is based on the international standards for conformity assessment bodies that have been harmonised in the New Legislative Framework and the references of which have been published in the Official Journal of the EU. It is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and where applicable any additional requirements, including those set out in relevant sectoral schemes. With Regulation No 765/2008, only national accreditation bodies are allowed to provide accreditation of conformity assessment bodies.
The reliance on harmonised standards, based on corresponding international standards, is intended to create the necessary level of transparency and confidence in the competence of conformity assessment bodies, and to ensure that the European accreditation system set up by Regulation (EC) No 765/2008 is compatible with the international accreditation system – therefore facilitating international trade.
Given the prominent role in the conformity assessment system that the Regulation has bestowed upon national accreditation bodies, accreditation bodies have to strictly follow the rules of the Regulation when assessing the competence of conformity assessment bodies. The legislator has decided to clearly limit the activities that an accreditation body may perform, keeping a tight control over their remit via the direct reference to harmonised standards. This also means that national authorities may therefore not require and should actively prevent their accreditation bodies from performing assessment services outside the full accreditation process or use conformity assessment standards that are not harmonised.
6.3.   Scope of accreditation







Accreditation is always sought and granted for a defined scope i.e. for specific conformity assessment activities.





Accreditation is the standards-based method of assessing and attesting the competence of conformity assessment bodies. Union policy has made use of accreditation as an instrument that is designed to create the conditions for mutual confidence because of its reliance on consensus standards. Mutual confidence can only be achieved through reliance on criteria that can be objectively verified, thus allowing transparency and comparability of conformity assessment. The relevant standards for conformity assessment bodies were produced with the intention of supporting the introduction of the conformity assessment procedures set out in Union harmonisation legislation (267). These standards are conceived to cover the general competence requirements for bodies performing conformity assessment to specified requirements, irrespective of whether these are contained in regulations, standards or other technical specifications or whether such specifications are performance-based or product-specific. This concept supports the role of accreditation as a tool to facilitate the free movement of products within the internal market and has been taken over by the ISO/IEC 17000 standards at international level.
As stated in the respective clauses covering their scope, the standards specify criteria for bodies irrespective of the sector concerned. However, accreditation is always sought and granted for a defined scope, i.e. for specific conformity assessment activity and, where applicable, the types of test performed and methods used (e.g. ‘Body X is competent to undertake inspections as a type A body in the area of pressure equipment categories of Directive 2014/68/EU’) and is never restricted to the mere compliance with the general 17000 standards. Therefore, accreditation on the basis of compliance with the 17000 standards always implies the need for these general criteria to be complemented and further specified by all technical specifications that are relevant for the specific technical area for which the applicant conformity assessment body seeks accreditation. Thus, accreditation implies verification of competence with regard to the current state of the art, and includes assessment on the basis of the standards for conformity assessment bodies and all relevant product- and/or technology-related regulations, standards and other specifications.
6.4.   Accreditation according to Regulation (EC) No 765/2008












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Each Member State may appoint one single national accreditation body.











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Accreditation is to be operated as a public authority activity.











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The responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities.











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Accreditation is to be provided on a not-for-profit basis.











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Within the EU, accreditation bodies are not allowed to compete with other accreditation bodies.











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Within the EU, accreditation bodies are only to be active on the territory of their own Member State.









6.4.1.   
National accreditation bodies


The Regulation foresees that each Member State may appoint one single national accreditation body. Only the national accreditation bodies are allowed to perform accreditation of conformity assessment bodies. No other bodies may claim to provide such services, be it according to harmonised standards or non-harmonised standards. This provision is central to the functioning of accreditation in the EU and to the framework of accreditation set up by the Regulation. Member States are not obliged to set up their own national accreditation body, should they consider it not economically viable to do so or should they not deem it useful to offer accreditation for all activities. This means that at no time more than one accreditation body may be active on the territory of a Member State for a given activity. In order to ensure transparency, Member States are therefore obliged to inform the Commission and other Member States to which national accreditation body of another Member State they are having recourse.
A list of national accreditation bodies is available online (268). National accreditation bodies have to make the activities for which they perform accreditation publicly available.
The Regulation does not prescribe the legal form a national accreditation body should take. This means that the national accreditation body may operate from within a ministry, be a governmental agency or be organised as a private company. The Regulation is, however, very clear in that accreditation is to be operated as a public authority activity and, to this effect, has to be formally recognised by the Member State.
Furthermore, the responsibilities and tasks of the national accreditation body have to be clearly distinguished from those of other national authorities. This provision aims to enhance the independence of the national accreditation body and the impartiality and objectivity of its activities. Should the national accreditation body be part of a larger public structure, such as a ministry, other departments are not allowed to influence accreditation decisions. The process of accreditation has to remain separate from other functions. It is absolutely essential to avoid a conflict of interest of the national accreditation body. This also applies to certain tasks that the national accreditation body may take on. While Decision No 768/2008/EC foresees that the national accreditation body may function as a notifying authority (269), the delegation of powers has to be clearly documented and the conditions for impartiality, namely the separation of tasks within the accreditation body ensured.
Should notification tasks be delegated to the national accreditation body, the body’s obligations under the Regulation nevertheless remain applicable. This means that its task remains the assessment of the technical competence of conformity assessment bodies according to the full accreditation process and an accreditation certificate must be issued if the technical competence of the conformity assessment body has been established. The national accreditation body may not perform any other assessments that do not meet these requirements or that meet less strict requirements which would not warrant the issuing of an accreditation certificate.
In other words, if the task of notification is to be delegated to the national accreditation body, only the notification of accredited conformity assessment bodies would be possible. The notification of conformity assessment bodies whose competence has not been assessed against the full accreditation criteria will not be possible where such a delegation has been decided on. This also means that the national accreditation body would not exercise any discretion in the notification of a body – the relevant accreditation certificate would lead to an automatic notification (270).
In addition, when providing accreditation, the national accreditation body has to fulfil a number of conditions in terms of stakeholder representation, its internal management and internal controls. Decisions on assessment have to be taken by a different person to the one who carried out the assessment of the conformity assessment body. The accreditation body has to have enough competent personnel at its disposal to ensure that it can perform its tasks. Procedures have to be in place to make sure that the personnel performs adequately and is competent to carry out its tasks. Also, adequate arrangements to ensure the confidentiality of the information obtained from conformity assessment bodies have to be in place and the accreditation body is obliged not to impose unnecessary burdens on its clients. Accreditation bodies must also have a complaint handling mechanism in place.
Furthermore, the Regulation states that the national accreditation body has to have sufficient resources to fulfil its tasks; this includes on the one hand a sufficient number of competent personnel, but also special tasks such as activities for European and international accreditation cooperation and activities that are required in support of public policy and which are not self-financing. In this respect adequate participation in EA, its committees and the peer evaluation process are of foremost importance. Member States should facilitate the participation of their national accreditation bodies in this kind of activities.
In this vein, national accreditation bodies are also obliged to publish their annual audited accounts. The intentions of this provision go beyond demonstrating sound financial management, for the purposes of peer evaluation. National accreditation bodies must therefore clearly demonstrate that the guiding principles of non-commerciality and sufficient resources for ensuring its competence in all activities are respected. Bearing in mind the overall objective of the Regulation of establishing accreditation as the last level of control in the conformity assessment system, in those cases where the accreditation body is part of a larger structure, this requirement should thus be understood to be a tool to demonstrate compliance with these principles, rather than being used to create unnecessary bureaucratic burdens for Member States. Thus the accreditation bodies situated in ministerial departments must be in a position to present at least their overall budgetary and financial figures covering overall resources and their global and operational expenses; together with any financial policies that apply to them in order to be able to demonstrate that they have sufficient resources to perform their tasks adequately while safeguarding the principle of non-commerciality.
Member States have the responsibility to ensure that their national accreditation bodies meet the requirements foreseen by the Regulation on an on-going basis and to take corrective action if this should not be the case. For this reason, they are to take the utmost account of the results of the peer evaluation organised by the European accreditation infrastructure.
6.4.2.   
Non-competition and non-commerciality of national accreditation bodies


The Regulation’s aim of setting up a coherent framework for accreditation that establishes accreditation as the last level of control is underpinned by the principles of non-commerciality and non-competition.
For this reason, while accreditation is supposed to be a self-supporting activity, it is to be provided on a not-for-profit basis. This means that national accreditation bodies do not have the objective of maximising gains or distributing profits. They may provide their services in return for payments or receive income, but any excess revenue is to be invested in further developing their accreditation activities as long as these correspond to the overall tasks of the accreditation bodies. The primary objective of accreditation remains not to produce any gain but to fulfil a task in the public interest.
Regular excess revenues could be a signal that there is a potential to reduce the tariffs charged for accreditation and to encourage smaller conformity assessment bodies to apply for accreditation. Given the prominence that the Regulation gives to accreditation’s not-for-profit character, recital 14 clarifies that accreditation is not to produce any gains to its owners or members. In the case that there should nevertheless be any gains, the situation may be corrected by the reduction of tariffs or the revenue may be reused for the further development of accreditation, so as to avoid any conflict with the not-for-profit principle of the Regulation. One could reasonably expect that any excess revenues generated by an accreditation body could also be used to support the accreditation body’s involvement in the accreditation activities in the European, international or public sphere.
Regardless of the legal structure of the national accreditation body, there should thus not be a regular transfer of excess revenue to the owners or members of the national accreditation body – be they public or private. Using accreditation as another form of revenue for the state would in consequence cast serious doubts on its compliance with the Regulation’s intentions concerning the not-for-profit character of accreditation
Following the same logic, accreditation is to be established as a clearly distinct activity from any conformity assessment activities. A national accreditation body is therefore not allowed to offer or provide any activities or services that a conformity assessment body offers or provides. Neither may it provide consultancy services, own shares in or otherwise have a financial interest in a conformity assessment body or compete with conformity assessment bodies, so as to avoid any kind of conflict of interest.
Furthermore, to safeguard the principle of non-commerciality the Regulation also foresees that accreditation bodies are not allowed to compete with other accreditation bodies. Within the EU, they are only to be active on the territory of their own Member State. Only in exceptional cases, specified in Article 7.1 of Regulation (EC) No 765/2008 is cross-border accreditation foreseen. Unless these conditions are met, conformity assessment bodies have to seek accreditation with the national accreditation body of the Member State they are established in. This applies for all conformity assessment activities that take place in Europe and concern products or services that are to be placed on the market (271).
6.5.   The European accreditation infrastructure












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The European co-operation for Accreditation (EA) is the organisation of European national accreditation bodies.











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EA is central to the implementation of Regulation (EC) No 765/2008 and one of its most important tasks is the organisation of the peer evaluation system of national accreditation bodies.











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EA’s tasks may also include the development or the recognition of sector schemes.









The Regulation provides for the recognition of a European accreditation infrastructure. For the time being, this is the European co-operation for Accreditation (EA), the regional organisation of European national accreditation bodies. EA is central to the implementation of the Regulation and through the peer evaluation system is the body that has the closest oversight of the practical functioning of accreditation in Europe. The Commission and EA have concluded a framework partnership agreement on the basis of which EA carries out its tasks. One of EA’s primary tasks is to operate a peer evaluation of national accreditation bodies, in line with international standards and practice, but it also contributes to the wider development, maintenance and implementation of accreditation in the EU.
6.5.1.   
Sectoral accreditation schemes


At the request of the Commission, EA’s tasks may include the development of sectoral accreditation schemes or the acceptance of existing schemes. A sector scheme is a scheme that is based on a relevant standard for a specific product, process, service etc. and additional requirements that are specific to the relevant sector and / or specific legislation. Accreditation may be called upon to assess the competence of conformity assessment bodies to carry out assessments with regard to such schemes.
EA may contribute to the development of sector schemes and their corresponding evaluation criteria and peer evaluation procedures. EA may also recognise already existing schemes that lay down their evaluation criteria and peer evaluation procedures.
In the case of sector schemes that are linked to EU legislation, the Commission has to ensure that the proposed scheme meets the necessary requirements of the legislation in question in terms of the public interest expressed by this specific legislation.
6.5.2.   
Peer evaluation


One of the most important tasks of EA is the organisation of the peer evaluation system of national accreditation bodies, which is the cornerstone of the European accreditation system.
National accreditation bodies undergo peer evaluations of their systems, procedures and structures at a maximum of four year intervals. The aim of the peer evaluation system is to ensure consistency and equivalence of accreditation practices across Europe so that the wider market place, including the national public authorities (272), mutually recognise the services delivered by those bodies that have successfully passed the peer evaluation, and therefore accept the accreditation certificates and the attestations issued by the conformity assessment bodies accredited by them. EA provides an appropriate training system to ensure the coherence of peer evaluation activities and results across Europe. Successful peer evaluation allows a national accreditation body to sign the EA Multilateral Agreement, or to maintain signature status. Under the EA Multilateral Agreement, all signatories are obliged to recognise the equivalence of each other’s accreditation systems and the equal reliability of the attestations issued by the conformity assessment bodies accredited by them.
The peer evaluation system is operated at several levels. First of all national accreditation bodies have to meet the requirements of the harmonised standard EN ISO/IEC 17011 ‘Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies’ and the requirements of the Regulation which are not contained in the international accreditation body standard – these are namely the principles of one national accreditation body acting as public authority, non- commerciality and non-competition.
Accreditation bodies then have to demonstrate that they are capable and competent to carry out accreditation in the different fields of conformity assessment serviced by them. These activities are themselves determined by a number of harmonised standards (such as EN ISO/IEC 17025 for testing and calibration laboratories, EN ISO/IEC 17020 for inspection bodies or EN ISO/IEC 17065 for bodies certifying products, services and processes). In addition, peer evaluators have to make sure that the accreditation body takes into account any other requirements in its assessments, which are relevant for the specific conformity assessment activities to be carried out by the bodies which they accredit. These may be the specific requirements contained in conformity assessment schemes, including European and national schemes.
6.5.3.   
Presumption of conformity for national accreditation bodies


If a national accreditation body can demonstrate as a result of the peer evaluation process that it meets the requirements of the relevant harmonised standard (273), it is presumed to meet the requirements for national accreditation bodies that are outlined in Article 8 of the Regulation.
More importantly - and this is of specific importance for the regulatory sphere – if a national accreditation body has successfully undergone peer evaluation for a specific conformity assessment activity, national authorities are obliged to accept the accreditation certificates issued by this body, as well as any attestations (e.g. test or inspection reports, certificates) issued by conformity assessment bodies accredited by this accreditation body.
6.5.4.   
EA’s role in supporting and harmonising accreditation practice across Europe


Following on from EA’s role as the organisation that is in charge of the peer evaluation of national accreditation bodies there is a need to arrive at a coherent and equivalent approach to accreditation which then warrants the mutual recognition and acceptance of conformity assessment attestations. This means that EA has to facilitate a common approach to accreditation practice and towards the harmonised standards and the requirements that may be contained in any sector schemes. Therefore, with the involvement of all parties concerned such as stakeholders and national authorities, EA has to develop transparent guidance that its members have to respect when conducting accreditation.
6.6.   Cross-border accreditation







The possibility of a conformity assessment body to request accreditation with a national accreditation body in another Member State is only allowed in a limited number of cases.





According to Article 7(1) of Regulation (EC) No 765/2008, conformity assessment bodies, whether third-party or first-party/ in-house, are required when requesting accreditation to do so with the national accreditation body of the Member State in which they are established. This general rule allows for exceptions: the possibility of a conformity assessment body to request accreditation with a national accreditation body in another Member State is limited to cases where






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there is no national accreditation body in its own Member State and no other national accreditation body to which recourse is had [Article 7(1)(a)],










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the national accreditation body does not offer the requested accreditation service [Article 7(1)(b)],










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the national accreditation body has not received a positive outcome in the peer evaluation in relation to the conformity assessment activity for which accreditation is requested i.e. the national accreditation body is not a signatory to the EA Multilateral Agreement for the accreditation of the conformity assessment activity concerned [Article 7(1)(c)].




Article 7(1) of the Regulation is closely linked to and is a logical consequence of the non-competition principle.
The cross-border provision laid down in Article 7 is perceived to be very stringent and unnecessarily burdensome for multi- nationally active conformity assessment bodies having their head office in one Member State with local entities/sites established in other Member States and working under the supervision of the head office and under the same quality system and management, as implying costly duplications of assessments. The risk of suffering a competitive disadvantage compared to third-country organisations is feared. In case of a strict legal interpretation of Article 7, due to their structures, multinational conformity assessment bodies may not benefit from the advantage of one accreditation certificate sufficient for the whole territory of the EU, although avoiding multiple accreditations is one of the objectives of the Regulation.
The duplication of unnecessary assessments and burdens on multinational conformity assessment bodies should be avoided while ensuring adequate control of local entities of conformity assessment bodies. There has to be an exchange of information and effective cooperation between national accreditation bodies for assessment, re-assessment and surveillance of local sites of multinational conformity assessment bodies where necessary. Based on mutual recognition of all assessments carried out by EA members, any duplication of assessments of organisational aspects or requirements should be strictly avoided.
If necessary and on reasoned request, relevant information on carrying out accreditation against national legislative requirements of another Member State and/or requirements set out in relevant national sectoral schemes are to be provided by the local national accreditation body to the national authorities of the other Member State. National authorities of the Member States in which the local national accreditation body is established should be kept informed thereof.
The conformity assessment bodies with local sites (regardless of their legal personality), provided that the latter operate under the same global quality system and management and that the head office has the means to substantially influence and control their activities, can be considered as being only one organisation with regard to the conformity assessment activity carried out. Such a conformity assessment body is therefore allowed to request accreditation with the national accreditation body of the head office whose scope can also cover the activities performed by the local site, including those located in another Member State.
In cases of accreditation for notification, the supervision of multi-site accredited bodies is done under the cross-border cooperation among the national accreditation bodies; however, the responsibility remains with the national accreditation body of the Member State in which the conformity assessment body is established. The conformity assessment body as the main entity to be accredited and notified must have itself the means and the competence to carry out the tasks required for the accreditation. While it may have recourse to subsidiaries/subcontracting, it should not rely for all tests and evaluations on subsidiaries/subcontractors.
The notified accredited conformity assessment body may subcontract specific tasks connected with the conformity assessment, has to ensure that the subcontractor meets the same requirements that are applicable to the notified accredited body itself and may subcontract specific activities only with the agreement of the client (274).Thus, structures where the head office of the candidate-accredited body in the Member State of notification consists of very few staff performing only commercial tasks but none of the conformity assessment tasks for which the body is (to be) notified would be carried out in that Member State cannot be accepted. The multi-site accreditation is however only permitted under the Regulation if the accredited conformity assessment body maintains the final responsibility for the activities performed by local sites covered by the scope of the multi-site accreditation. The accreditation certificate issued by the national accreditation body where the head office is established names one legal entity - the head office - and it is this legal entity which holds the accreditation and which is responsible for the accredited activities of the conformity assessment body, including any activity performed by the local site that forms part of the scope of the accreditation. Where these local sites carry out key activities, then the accreditation certificate (in its annexes) has to clearly identify the address of these site offices.
The local site is entitled to offer directly to the local market conformity attestations under the multisite accreditation, but only on behalf of the accredited conformity assessment body. These accredited certificates and reports are therefore issued under the accreditation, name and address of the head office without the logo of the local site. However this does not impede mentioning on the conformity assessment certificate or report the contact details of the local site issuing the certificate or report in question.
The multi-site accreditation is meant for use only by companies within the same organisation and where the head office maintains the responsibility for the activities performed and certificates/reports issued by the local sites. The responsibility has to be demonstrated on the basis of contractual or equivalent legal relationships between the head office and the local entity and internal regulations that further specify these relationships in terms of management and responsibilities.
The solution of the multi-site accreditation can be applied to all types of local entities (subsidiaries, branches, agencies, offices etc.), regardless of their legal personality and is in principle valid for all types of conformity assessment bodies, including laboratories, inspection and certification bodies as long as they carry out clearly identified and relevant activities for the purpose of accreditation.
The multi-site accreditation solution is excluded when the above mentioned conditions are not fulfilled, i.e. the conformity assessment body cannot be considered as one organisation with regard to conformity assessment and the head office does not maintain the ultimate responsibility for the activities of the local entities. In this case the local sites being separate legal entities should apply for their own accreditation with the local national accreditation body. As a consequence it can be considered that the local entity carries out the conformity assessment service completely independently of the head office.
In case of the multi-site accreditation, initial assessment and reassessments must be carried out in close cooperation between the respective local national accreditation body and the national accreditation body of the head office taking the accreditation decision, while surveillance must be carried out in cooperation with or by the local national accreditation body. The multinational conformity assessment body must fully cooperate with the national accreditation bodies involved. Local entities cannot reject the participation of the local national accreditation body in the assessment, reassessments and surveillance process. Harmonised rules for co-operation between national accreditation bodies exist in the form of the EA cross frontier policy. Multi-site accreditation has to be managed under the EA cross frontier policy in order to guarantee the involvement of the local national accreditation body.
The multi-site accreditation does not supersede sub-contracting, which remains a viable solution in case a conformity assessment body may wish to sub-contract part of its activities to legal entities located and operating in the same or other Member States, which however do not belong to the same organisation, i.e. are not part of a multinational conformity assessment body. In this case, the subcontractor is not covered by the accreditation of the conformity assessment body. The accredited conformity assessment body may subcontract specific parts of its conformity assessment activities to a different legal entity according to the applicable conformity assessment body standard to which it is accredited and only to the extent allowed in this standard. The conformity assessment body must be able to demonstrate to the national accreditation body that the subcontracted activities are carried out in a competent and reliable manner consistent with the applicable requirements for the activities in question. The accredited conformity assessment attestation must be issued exclusively under the name and responsibility of the accredited conformity assessment body, i.e. the legal entity holding the accreditation. The contractual relationship with the client remains with the accredited conformity assessment body.
6.7.   Accreditation in the international context







At international level, cooperation between accreditation bodies takes place within the International Accreditation Forum (IAF) and within the International Laboratory Accreditation Cooperation (ILAC).





6.7.1.   
Cooperation between accreditation bodies


Accreditation as an impartial means of assessing and conveying formal demonstration of the technical competence, impartiality and professional integrity of conformity assessment bodies is an effective quality infrastructure tool used worldwide.
At international level, cooperation between accreditation bodies takes place within two organisations: namely within the International Accreditation Forum (IAF) between accreditation bodies accrediting certification (products and management systems) bodies and within the International Laboratory Accreditation Cooperation (ILAC) between accreditation bodies accrediting laboratories and inspection bodies. Both organisations provide for multilateral mutual recognition arrangements between its accreditation body members. IAF manages a Multilateral Recognition Arrangement (MLA), while ILAC operates a Mutual Recognition Arrangement (MRA). These multilateral mutual recognition arrangements/agreements of competence at technical level between accreditation bodies have the ultimate aim to allow products and services accompanied by accredited conformity attestations to enter foreign markets without the need for re-testing or re-certification in the import country. The objective of such recognition arrangement/ agreements between accreditation bodies is therefore to contribute to reinforce the acceptance of conformity assessment results.
At the regional level, to date (275), cooperation organisations between accreditation bodies have been established in:






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Europe: European co-operation for accreditation (EA)










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America: Inter-American Accreditation Cooperation (IAAC)










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Asia – Pacific: Asia Pacific Laboratory Accreditation Cooperation (APLAC) and Pacific Accreditation Cooperation (PAC)










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Africa: Southern African Development Community Accreditation (SADCA)










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Africa: African Accreditation Cooperation (AFRAC)










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Middle East: Arab Accreditation Cooperation (ARAC)




Except for SADCA, AFRAC and ARAC which are currently developing their regional mutual recognition arrangements, the above listed cooperation organisations have agreements/arrangements in place within their region which the ILAC/IAF arrangements build upon. By granting special recognition IAF accepts the mutual recognition arrangements established within EA, IAAC and PAC: accreditation bodies being member of IAF and signatories to the EA Multilateral agreement (EA MLA) or the PAC Multilateral Recognition Arrangement (PAC MLA) are automatically accepted into the IAF MLA. ILAC accepts the mutual recognition arrangements and underlying evaluation procedures of EA, APLAC, and IAAC. Accreditation bodies which are not affiliated to any recognised regional cooperation entity may apply directly to ILAC and/or IAF for evaluation and recognition.
The requirements which the Regulation sets for accreditation bodies are in line with the globally accepted requirements laid down in the relevant international standards, although some of them can be perceived as being more rigorous. In particular:






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Accreditation is carried out by one single national accreditation body appointed by its Member State (Article 4.1)










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Accreditation is performed as a public authority activity (Article 4.5)










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National accreditation bodies operates free from commercial motivations (Article 8.1) and on a not-for- profit basis (Article 4.7)










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National accreditation bodies do not compete with conformity assessment bodies or among each other (Art 6.1 and Article 6.2)










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Cross-border accreditation Article 7 (within the EU and EEA)




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


The ultimate acceptance of conformity assessment attestations is decided by the public authorities in the regulatory sphere and, from an economic point of view, by industry users and consumers. The voluntary multilateral mutual recognition agreements between accreditation bodies taking place at technical level support, further develop and enhance trade agreements.
The requirements set out above affect the acceptance of non-European certificates and test results accredited by non-European accreditation bodies not complying with EU requirements but signatories to the ILAC/IAF MRA/MLA in the following way:






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Conformity assessment delivered in the voluntary sphere

It is up to the non-European conformity assessment body operating on the European market to decide if and where to get accredited. In order to boost the acceptance of its conformity assessment attestations by the European market (industry as purchasers of conformity assessment services and ultimately consumers) the non-European conformity assessment body opting for accreditation may choose whether to resort to the service of a third country accreditation body not necessarily conforming to the new European requirements but signatory to the ILAC/IAF MRA/MLA or rather to that of an accreditation body established in the Union. Non-European conformity assessment attestations issued under accreditation by non- European accreditation bodies not fulfilling European requirements can continue to be used on the European market but only in the voluntary sphere.










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Conformity assessment delivered in the mandatory sphere

Where conformity assessment is required in regulations, national authorities of EU Member States may refuse to accept attestations of conformity issued under accreditation by non-European accreditation bodies not complying with the EU requirements even though they may be signatories to the ILAC/IAF MRA/MLA.




However, where government-to-government Mutual recognition agreements (MRAs) between the Union and a third country in relation to conformity assessment are in place, national authorities of EU Member States shall accept the test reports and certificates issued by bodies that the foreign party has designated under the MRA for assessing conformity in the categories of products or sectors covered by the MRA. The products accompanied by such conformity attestations can be exported and placed on the other party’s market without undergoing additional conformity assessment procedures. Each importing party agrees, by the terms of the MRA, to recognise the conformity assessment attestations issued by agreed conformity assessment bodies of the exporting party, independently of whether accreditation has been used to back up the designation process of the conformity assessment bodies under the MRA or not, and independently of, in case accreditation is used by the non-European Party, the fulfilment by the third Party accreditation body of the EU requirements.
7.   MARKET SURVEILLANCE

Under Regulation (EU) 2019/1020, national market surveillance authorities have clear obligations to check products covered by Union harmonisation legislation made available on the Union market, to organise themselves and ensure coordination between themselves at the national level, and to cooperate at the EU level (276). Economic operators have the clear obligation to cooperate with the national market surveillance authorities and to take corrective action where necessary. National market surveillance authorities have the power to take appropriate sanctions in case of violation of legislative requirements.
Regulation (EU) 2019/1020 includes provisions on the control of products from third countries entering the Union market. It obliges national market surveillance and customs authorities to cooperate in order to ensure a seamless system. Such controls must be carried out in a non-discriminatory manner and on the basis of risk analysis.
The European Commission has the task to facilitate cooperation and the exchange of information between authorities across the EU. It aims to ensure that market surveillance is effectively EU-wide and that Member States can pool together their means, in particular through the Union Product Compliance Network (see point 7.6.3.3).
7.1.   Why do we need market surveillance?







Member States have to take appropriate measures to prevent the making available on the market and use (277)
of non-compliant products.





Market surveillance aims at ensuring that products fulfil the applicable requirements providing a high level of protection of public interests, such as health and safety in general, health and safety in the workplace, the protection of consumers, of the environment and of public security and any other public interest protected by the EU legislation. This objective is to be pursued while ensuring that the free movement of products is not restricted to any greater extent than is allowed under Union harmonisation legislation or any other relevant Union rule. Market surveillance entitles citizens to an equivalent level of protection throughout the single market, regardless of the origin of the product. Further, market surveillance is important for the interest of economic operators, because it helps to eliminate unfair competition.
Market surveillance activities are not directed exclusively towards the protection of health and safety: they also aim to enforce Union legislation designed to safeguard other public interests, for example by means of regulating the accuracy of measurement, electromagnetic compatibility, effective and efficient use of radio spectrum, energy efficiency, consumer and environment protection, in line with the principle of ‘high level of protection’ laid down in Article 114 (3) TFEU.
Member States must ensure effective surveillance of their market. They are required to organise and carry out the monitoring of the products made available on their market or imported through both online and offline sales and distribution channels. The objective is to ensure that products have been designed and manufactured in accordance with the requirements laid down in Union harmonisation legislation, that the marking and documentation requirements have been respected, and that they have been subjected to the necessary procedures.
Where Member States find this is not the case, they must require the relevant economic operators to take appropriate and proportionate corrective action to ensure compliance with the applicable requirements. Where economic operators fail to take corrective action, market surveillance authorities should take appropriate and proportionate measures to ensure that unsafe products, or products which otherwise do not conform to applicable requirements set out in Union harmonisation legislation, are kept or taken off the market and unscrupulous or even criminal operators punished. Member States should allow for sanctions proportionate to any infringements. These should also act as a deterrent, in particular in case of serious or repeated infringements.
7.2.   Scope of Regulation (EU) 2019/1020












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Regulation (EU) 2019/1020 applies to non-food products subject to a broad range of Union harmonisation legislation.











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Where Union harmonisation legislation includes specific rules on market surveillance, those rules prevail.











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With respect to controls at the external borders, the product scope of the Regulation is broader.









The scope of Regulation (EU) 2019/1020 is defined in its Article 2. Regulation (EU) 2019/1020 regulates market surveillance for most of the Union harmonisation legislation establishing specific requirements on the design, composition and labelling of non-food products, insofar as there are no specific provisions with the same objective in the Union harmonisation legislation. Some categories of products, such as medicinal products or railway equipment, are not covered because they have their own framework for enforcement. Annex I to Regulation (EU) 2019/1020 contains a list of legislation for which the Regulation is relevant. However, additional legislation is also concerned by Regulation 2019/1020, either by amendment to Annex I or through references in that legislation, for example:






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A specific reference to Regulation (EU) 2019/1020, such as in Directive (EU) 2020/2184 on drinking water (278)











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The inclusion of predecessor legislation in Annex I to Regulation (EU) 2019/1020 and a provision that references to the repealed legislation must be construed as references to the new legislation, such as in Regulation (EU) 2019/1009 on EU fertilising products (279).










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Both of the above, such as in Regulation (EU) 2020/740 on the labelling of tyres with respect to fuel efficiency and other parameters (280)





One act explicitly refers to the market surveillance provisions of Regulation (EC) No 765/2008 (without reference to Regulation (EU) 2019/1020): the European accessibility act (281). A number of provisions of Regulation (EU) 2019/1020 apply to this act through its Article 39(2) and the correlation table in Annex III to Regulation (EU) 2019/1020.
Directive (EU) 2019/904 on single use plastics (282) does not contain specific provisions or references for enforcement. Given that its product scope has a significant overlap with the Directive on packaging and packaging waste (included in Annex I of Regulation (EU) 2019/1020), Member States may want to apply at national level the market surveillance provisions of Regulation (EU) 2019/1020.
Delegated and implementing acts adopted under legislation for which Regulation (EU) 2019/1020 is relevant are themselves also covered. Some of the legislation for which Regulation (EU) 2019/1020 is relevant also contains provisions that do not concern the design, composition or labelling of products, such as the recovery and recycling targets laid down in Article 6 of Directive 94/62/EC on packaging and packaging waste. Regulation (EU) 2019/1020 is not relevant for such provisions.
Union harmonisation legislation for which Regulation (EU) 2019/1020 is relevant may also contain rules on market surveillance (283). The provisions of Regulation (EU) 2019/1020 on market surveillance apply to products that are subject to such Union harmonisation legislation in so far as there are no specific provisions with the same objective in the Union harmonisation legislation, which regulate in a more specific manner particular aspects of market surveillance and enforcement (the ‘lex specialis’ provision in Article 1(1)). This applies, for example, as regards the use of the European database on medical devices (Eudamed) (284) instead of the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 (285). In many cases, however, the market surveillance provisions in Union harmonisation legislation are complementary and do not render provisions of Regulation (EU) 2019/1020 inapplicable.
Article 4 (‘Tasks of economic operators regarding products subject to certain Union harmonisation legislation’) has its own specific scope specified in the Article. Specific guidance on Article 4 has been issued by the Commission (286).
The provisions regarding controls on products entering the Union (Chapter VII, i.e. Articles 25-28) have a broader product scope than the Union harmonisation legislation listed in Annex I. These provisions apply to products covered by Union law in so far as there are no specific provisions relating to the organisation of controls on products entering the Union market. This includes for example Directive 2001/95 on general product safety.
7.3.   Organisation of market surveillance












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Market surveillance is organised at national level and single liaison offices facilitate coordination.











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Member States should ensure that their authorities have sufficient resources and competences.











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National market surveillance strategies determine priorities.











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Market surveillance authorities need to inform the public on risks.











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The level of the sanctions is determined at national level.









Market surveillance is organised at national level based on the common framework laid down in Regulation (EU) 2019/1020. Member States have to appoint one or more market surveillance authorities, authorities in charge of the control on products entering through the EU’s external borders, and a single liaison office.
7.3.1.   
National infrastructures


Market surveillance is the responsibility of national public authorities (Article 10(1) of Regulation (EU) 2019/1020). This is, in particular, to guarantee the impartiality of market surveillance activities. Each Member State can decide upon the market surveillance infrastructure. For example, there are no requirements at Union level on the allocation of responsibilities between authorities, whether on a functional or geographical basis, as long as surveillance is effective and covers the whole territory.
Member States organise and carry out market surveillance through the establishment of market surveillance authorities (287) (Article 10(2) of Regulation (EU) 2019/1020). Market surveillance authorities are the authorities of a Member State responsible for carrying out market surveillance on their territory (Article 3(4) of Regulation (EU) 2019/1020). Surveillance of the market by public authorities is a fundamental element for the good implementation of Union harmonisation legislation.
Each Member State must designate a single liaison office that performs certain coordination tasks among the market surveillance authorities, as well as between these authorities and those in charge of the control on products entering the Union. Single liaison offices coordinate, in particular, the position of the national authorities in the cooperation activities undertaken at EU level (Article 10(4) of Regulation (EU) 2019/1020).
Member States must entrust market surveillance authorities with the powers, resources and knowledge necessary for the proper performance of their tasks (inter alia Article 14(1) of Regulation (EU) 2019/1020). Regulation (EU) 2019/1020 includes a minimum set of investigative and enforcement powers that Member States must confer on their authorities. Member State may require that certain powers be exercised by recourse to other public authorities or through courts decisions (Article 14(3) of Regulation (EU) 2019/1020). Member States may confer additional powers to those in the Regulation. Market surveillance authorities have to exercise their powers with proportionality (Article 14(2) of Regulation (EU) 2019/1020).
As regards personnel resources, the authorities have to possess, or have access to, a sufficient number of suitably qualified and experienced staff, with the necessary professional integrity. This must include the necessary capacities to address products made available online and offline with the same effectiveness (Article 10(5) of Regulation (EU) 2019/1020). It could include the designation of dedicated structures and staff for monitoring and tracing dangerous and non-compliant products sold online (288). Market surveillance authorities must exercise their powers and carry out their duties independently, impartially and without bias (Article 11(2) of Regulation (EU) 2019/1020). In carrying out their activities, they may use their own testing facilities or any other resources. They may also subcontract technical tasks (such as testing or inspection) to another body, provided that they retain the responsibility for their decisions. If technical tasks are subcontracted to a body which carries out conformity assessment activities for economic operators, there must be no conflict of interest between these conformity assessment activities and compliance assessment for the market surveillance authority. When subcontracting, the market surveillance authority should exercise great care to ensure that the impartiality of the advice it receives is beyond reproach. Responsibility for any decision taken on the basis of such advice should lay with the market surveillance authority.
7.3.2.   
National market surveillance strategies


Member States are required by Article 13 of Regulation (EU) 2019/1020 to draw up a national market surveillance strategy at least every four years. This strategy should be overarching, considering all sectors covered by Union harmonisation legislation and all sales channels and stages of the supply chains. On the basis of an assessment of compliance, market trends and emerging technological developments, it should identify priorities for enforcement.
The purpose of the strategies is to promote a smart and evidence-based approach to enforcement, to concentrate resources on priorities and to identify necessary capacity building for new challenges. They enable the identification of needs for increased cooperation between market surveillance authorities, and with the authorities in charge of the control on products entering the Union market.
The strategies should also allow other Member States to understand how and in which areas market surveillance will be carried out. The EU product compliance network will exchange expertise and best practices regarding the implementation of national market surveillance strategies. It will also evaluate the strategies, allowing to identify overlaps, synergies and gaps, particularly at the Union level.
To allow the strategies to take account of and to include sensitive information, they are only shared between Member States’ authorities and the Commission. This also applies to the results of the review and assessment of the market surveillance strategy that Member States need to undertake. Member States have to publish a summary of the market surveillance strategy to inform the public of their activities.
7.3.3.   Public information

Considering that the aim of market surveillance is to provide a high level of protection of certain public interests, informing the public is an essential element of market surveillance. Therefore, Member States should ensure openness to the public and to interested parties. They must make available to the public any information they consider relevant in order to protect the interests of end users in the Union (Article 17 of Regulation (EU) 2019/1020). This ensures more information and awareness to both consumers and economic operators. In accordance with the principle of transparency, information available to the authorities of the Member States or to the Commission relating to risks to health and safety, or to other public interests protected under EU harmonisation legislation posed by products, should in principle be available to the public. This is without prejudice to the restrictions required for protecting intellectual property rights and confidential business information, for preserving personal data, and for monitoring, investigation and prosecution activities. (289)

One of the obligations of market surveillance authorities is to ensure that users in their territories are alerted within an adequate timeframe of hazards and risks they have identified relating to any product. This is meant to reduce the risk of injury or other damage, particularly when the economic operator responsible fails to do so (Articles 16 (3) and 16(5) of Regulation (EU) 2019/1020).
Market surveillance authorities must also ensure that consumers and other interested parties are given an opportunity to submit complaints to the competent authorities and that these complaints are followed up appropriately (Article 11(7)(a) of Regulation (EU) 2019/1020).
7.3.4.   
Sanctions


Regulation (EU) 2019/1020 requires Member States to take appropriate action when economic operators do not comply with the applicable obligations. The Regulation provides that market surveillance authorities must have the power to impose penalties (Article 14(4)(i) of Regulation (EU) 2019/1020). Member States have to lay down the rules for such penalties (Article 41 of Regulation (EU) 2019/1020), in accordance with the requirements included in Union harmonisation legislation (290) and/or in Regulation (EU) 2019/1020. Such penalties have to be effective, proportionate and dissuasive. They may be applied directly by market surveillance authorities or through procedures involving the courts, depending on each Member State’s legal system. In addition, Regulation (EU) 2019/1020 allows Member States to confer to their market surveillance authorities the power of reclaiming from the relevant economic operator, if they wish so, the costs of the market surveillance activities that were undertaken in relation to a product found to be non-compliant (Article 15(1) of Regulation (EU) 2019/1020). As the Regulation refers to the totality of the costs of the activities of market surveillance authorities with respect to instances of non-compliance, the type of costs that can be reclaimed is broad and not limited to the examples provided in Article 15(2). At the same time, as for all powers, market surveillance authorities should exercise this power in accordance with the principle of proportionality e.g. a formal non-compliance such as CE marking that has not been affixed indelibly will normally not cost much to notice and follow-up on.
7.4.   Checks by Market Surveillance authorities












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Market surveillance occurs at the marketing stage of the products.











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Market surveillance prioritises resources and actions through a risk-based approach.











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Market surveillance activities may be organised differently depending on the nature of the product and the legal requirements, and they may range from control of formal requirements to in-depth laboratory examinations.











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Non-compliant products are subject to corrective actions, sales prohibitions, withdrawals or recalls.











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All economic operators have a role and obligations in market surveillance.









Market surveillance authorities shall check the compliance of the product with the legal requirements applicable at the moment of the placing on the market or, if relevant, putting into service. Checks carried out within the framework of market surveillance may be carried out at different stages of the distribution of a product following its placing on the market, or putting into use. It can, therefore, be exerted in various locations.
7.4.1.   
Market surveillance activities


Market surveillance authorities have to perform appropriate checks on an adequate scale of products made available online and offline (Article 11(1)(a) and 11(3) of Regulation (EU) 2019/1020). For market surveillance to be efficient, a risk-based approach has to be followed (Article 11(3) of Regulation (EU) 2019/1020). Resources should be concentrated where risks are likely to be higher or non-compliance more frequent. The risk-based approach should take into account aspects of products (level of potential hazards, non-compliance and associated risks; occurrence on the market), economic operators (activities and operations, past record of non-compliance) and information about both received from other actors (such as border control authorities, consumer complaints, media) as well as other sources that might indicate non-compliance such as incidents and accidents.
Market surveillance authorities do not necessarily check all the possible requirements on, or all properties of, a product. Usually, only some of these requirements and properties are selected for inspection.
Checks by market surveillance authorities may include inter alia:






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conducting online inspections;










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visiting commercial, industrial and storage premises;










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visiting, if appropriate, work places and other premises where products are put into service (291);requesting necessary information; and










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taking samples of products, and to subject them to examination and testing.




The first level of control comprises documentary and visual checks, for example regarding the CE marking and its affixing, the availability of the EU declaration of conformity, the information accompanying the product and the correct choice of conformity assessment procedures. In the case of online checks, the first level of control is checking the information available on the website where the product is offered for sale, potentially followed by requesting compliance documentation or acquiring the product for further inspection.
More in-depth checks may, however, be necessary to verify the conformity of the product, for example regarding the correct application of the conformity assessment procedure, the compliance with the applicable essential requirements, and the contents of the EU declaration of conformity. Especially when there are sufficient reasons to believe that a product presents a risk, market surveillance authorities carry out an evaluation in relation to the product concerned covering the requirements of the relevant Union harmonisation legislation (292).
Where economic operators present test reports or conformity assessment certificates issued by an accredited conformity assessment body, market surveillance authorities have to take due account of such reports or certificates (Article 11(5) of Regulation (EU) 2019/1020). Voluntary initiatives, such as product certification or application of a quality management system, cannot be put on the same footing as market surveillance activities carried out by an authority. Still, they can contribute to the elimination of risks and non-compliances. However, market surveillance authorities must be impartial regarding all voluntary marks, labels and arrangements: these may only be taken into consideration, in a transparent and non-discriminatory way, for the risk and compliance assessment. Accordingly, products should not be excluded from market surveillance operations even if they have been subject to voluntary certification or other voluntary initiatives.
7.4.1.1.   Requesting compliance documentation

Union harmonisation legislation provides for two different tools that enable market surveillance authorities to receive information on the product: the EU declaration of conformity and the technical documentation. These must be made available by the manufacturer, the authorised representative established within the Union or under certain circumstances by the importer or the fulfilment service provider established within the Union (293).
Other natural or legal persons, such as distributors are in principle not obliged to make these available (294). However, they are expected to assist the market surveillance authority in obtaining them. Further, the market surveillance authority may request the notified body to provide information on the conduct of conformity assessment for the product in question.
The EU declaration of conformity must be made available to the market surveillance authority without delay upon request (295). It shall accompany the product where so required by specific Union harmonisation legislation.
The technical documentation must be made available to the market surveillance authority within a reasonable period of time, in response to a reasoned request (Article R2(9) of Annex I to Decision No 768/2008). The authority cannot request it systematically. In general, it can be requested during checks made for market surveillance purposes, or when there are grounds for concern that a product does not offer the level of protection required in all respects.
More detailed information (for example certificates and decisions from the notified body) can, nevertheless, be requested in cases of doubt about the conformity of the product to the applicable Union harmonisation legislation (Article R2(9) of Annex I to Decision No 768/2008). The full technical documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be checked.
This request has to be evaluated in accordance with the principle of proportionality and, thus, taking into account the need to ensure the health and safety of persons or other public interests foreseen in the applicable Union harmonisation legislation, as well as to protect the economic operators from unnecessary burden. Furthermore, failure to present the documentation in response to a reasoned request by a national market surveillance authority, within an acceptable timeframe, is a non-compliance and may constitute sufficient grounds for doubting the conformity of the product with the essential requirements of the applicable Union harmonisation legislation.
In the case of a reasoned request, it is sufficient for the manufacturer to provide the part of the technical documentation related to the claimed non-conformity and appropriate for demonstrating whether the issue has been dealt with by the manufacturer. Therefore, any request for translation of technical documentation should be limited to these parts of the documentation. If the market surveillance authority considers a translation necessary, it must clearly indicate the part of the documentation to be translated and allow reasonable time for this to take place. No further conditions may be imposed on the translation, such as a requirement of a translator accredited or recognised by the public authorities.
A national authority might accept a language they understand and which is different from the national language(s). The language chosen could be a third language, if accepted by that authority.
It must be possible to make the technical documentation available in the Union. However, it does not need to be kept inside the Union, unless otherwise provided for in the applicable Union harmonisation legislation. The requirement for making it available does not mean that the economic operator who carries this obligation has to store it itself (296), as long as he is capable of presenting it on request from the national authority. Further, the technical documentation can be kept and sent to market surveillance authorities in paper or electronic form, which allows it to be made available within a period of time commensurate with the risk or non-compliance in question. Member States must ensure that everyone receiving information about the contents of the technical documentation during market surveillance activities is bound to confidentiality according to principles laid down in the national legislation.
7.4.2.   
Market surveillance measures


Where, having performed an evaluation, a market surveillance authority finds that a product is non-compliant or that a product is compliant but presents a risk to the health or safety of persons or to other aspects of public interest protection (297), it has to follow a sequence of procedures aimed at ensuring that appropriate and proportionate action is undertaken across the EU. These procedures are laid down in Articles 16, 18, 19 and 20 of Regulation (EU) 2019/1020 and, for a large part, in more detail in Union harmonisation legislation, in line with the safeguard procedures laid down in Articles R31 and R32 in Annex I of Decision No 768/2008/EC. (298)

7.4.2.1.   Process

Market surveillance authorities must first contact the relevant economic operator, informing it about the findings and giving an opportunity to provide its view within period of no less than 10 working days (299). This step is skipped in case of urgency based on health, safety or other aspects of public interest grounds. In such case, the economic operator must be given such opportunity as soon as possible afterwards.
The next step (300) is to require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk. The market surveillance authorities must also inform the relevant notified body (if any) in case an applicable safeguard procedure in the Union harmonisation legislation concerned specifies so (301).
If there is a manufacturer, authorised representative or importer in the EU, the market surveillance authority should address them directly, unless the issue specifically relates to a distributor or another economic operator (302). If there is none of these economic operators in the EU, then, for certain categories of products, the market surveillance authority has the option of contacting the fulfilment service provider in the EU, if there is one. Otherwise, the market surveillance authority should attempt to contact the manufacturer in the third country.
There is a range of actions possible, including but not limited to the actions listed in Article 16(3) of Regulation (EU) 2019/1020. These range from rectifying formal non-compliance to withdrawing or recalling the products. The action must be in accordance with the degree of risk or non-compliance, and the impact on the free circulation of products may not go beyond what is necessary for achieving the objectives of market surveillance (see Section 7.4.2.2). A different approach may apply in the case of serious risk. Market surveillance authorities carry out a risk assessment in order to verify if products present a serious risk. According to Article 19(2) of Regulation (EU) 2019/1020, an appropriate risk assessment ‘takes account of the nature of the hazard and the likelihood of its occurrence’. In case the risk is deemed to be ‘serious’, market surveillance authorities must adopt a rapid intervention following the specific provisions of Articles 19 and 20 of Regulation (EU) 2019/1020. The types of actions in this case consist in withdrawing or recalling the products, except where there is another effective way to eliminate the serious risk. Market surveillance authorities may, in these urgent cases, adopt restrictive measures without waiting for the economic operator to take corrective action. In such case, the economic operator must be given an opportunity to provide its view as soon as possible after a decision, order or measure taken, which shall then be reviewed promptly by the market surveillance authority (Article 18(3) of Regulation (EU) 2019/1020).
Economic operators must ensure that the corrective action is taken throughout the EU. If the non-compliance or risk relates only to part of a series of products manufactured that can be reliably identified, only that part needs to be addressed. If there is a doubt about either the risk being limited to a certain part or the reliable identification of that part, the corrective action should concern all the products/series. For an isolated error, limited to the territory of the Member State that has discovered the non-compliance, there is no need to take action throughout the EU.
Market surveillance authorities have to verify that corrective action has been taken. If an economic operator does not take adequate corrective action within the period indicated by a market surveillance authority, the market surveillance authorities have to take appropriate measures to prohibit or restrict the making available of the product on their national market, to withdraw the product from that market or to recall it. These measures have to be communicated to the relevant economic operator without delay.
Market surveillance authorities must inform the Commission and the other Member States about the results of the compliance evaluation and about the actions required of the economic operator or the measures adopted. In case of serious risk, market surveillance authorities notify to the Commission through RAPEX system of any voluntary or compulsory measure according to the procedure laid down in Article 20 of Regulation (EU) 2019/1020 and/or Article 12 of Directive 2001/95 on general product safety. In the case of products that do not present a serious risk, the Commission and the other Member States will be informed by means of the information support system provided for in Article 34 of Regulation (EU) 2019/1020 and, where appropriate, Article 11 of Directive 2001/95 on general product safety.
Market surveillance authorities in the other Member States will normally have to follow up on the notification by verifying whether the same product has been made available on their territories and by adopting appropriate measures. Additional information on this is provided in Sections 7.5.1 and 7.5.2, as well as in the RAPEX guidelines.
Any measure, decision or order taken or made by national market surveillance authorities must state the exact grounds on which it is based. The relevant economic operator must be notified. They must also be informed about the remedies available under the national law in force in the Member State in question, and of the time limits for such remedies.
7.4.2.2.   Different types of non-compliance and actions

Requirements in Union harmonisation legislation include both the essential requirements, and a number of administrative and formal requirements. When competent national authorities discover that a product is not in compliance with the provisions of the applicable Union harmonisation legislation, they must take action to ensure it is brought into conformity or taken off the market or recalled.
The corrective action depends on the risk or non-compliance and, thus, must be in accordance with the principle of proportionality. Non-conformity to essential requirements must generally be considered as a substantial non-compliance, because this may lead to the product presenting a potential or actual risk to the health and safety of persons or to other aspects of public interest.
If a product covered by Union harmonisation legislation is not CE marked, it is an indication that the product does not comply with the essential requirements or that the conformity assessment procedure has not been applied and, consequently, the product may endanger the health and safety of persons or harm other public interests protected by that legislation. Only if, following further investigation, the product proves to be compliant with the essential requirements, the absence of the CE marking is to be considered as a formal non-compliance (i.e. the product does not present a risk).
Unless there are reasons to believe that the product presents a risk, there are cases where non-compliance with a number of administrative or formal requirements are defined as formal non-compliance by certain Union harmonisation legislation. The incorrect affixing of the CE marking as regards, for instance, the design, size, visibility, indelibility or legibility, can usually be considered as a formal non-compliance. Further examples include situations where other conformity markings provided for in the Union harmonisation legislation are incorrectly affixed, or where the EU declaration of conformity cannot be provided for immediately or it does not accompany the product when this is mandatory, or the requirement to accompany other information provided for in sectoral Union harmonisation legislation is complied with insufficiently, or, where applicable, the identification number of the notified body has not been affixed to the CE marking.
PROSAFE (303)‘Guidelines for Businesses to manage Product Recalls & Other Corrective Actions’ have been designed to assist businesses to ensure, whenever necessary, the appropriate corrective actions and follow-up once a product has been already made available on the EU market or is coming from third countries.
Actions to prohibit or restrict the placing on the market may first be temporary to allow the market surveillance authority to obtain sufficient evidence about the risk or other substantial non-compliance of the product.
7.5.   Control on products from third countries












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Carrying out controls during the import process is an effective way of preventing unsafe or non-compliant products from entering the EU.











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Authorities designated for the control on products entering the Union market and market surveillance authorities have to cooperate closely.











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Regulation (EU) 2019/1020 contains procedures for dealing with products suspected to be non-compliant by border authorities.











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The release for free circulation shall not be deemed proof of conformity with Union law.









All products made available on the Union market must comply with the applicable EU legislation, irrespective of their origin. The most effective approach to prevent non-compliant products or products presenting a risk from entering the EU is to carry out controls during the import process, before the products are released for free circulation and can subsequently circulate within the European Union. Thus, the authorities in charge of the control on products entering the Union market (mostly, though not always, customs and therefore hereafter referred to as ‘border authorities’) play a crucial role in carrying out first-line controls on the compliance and the absence of risks on products originating from third countries (hereafter referred to as ‘border controls’).

This section only addresses the control of products entering the EU which are subject to Union harmonisation legislation, as explained in Section 1.2.1.

7.5.1.   
Role of border authorities


Border authorities may be the customs authorities of a Member State, market surveillance authorities or other entities depending on the national organisational structure (Article 25(1) of Regulation (EU) 2019/1020). In most countries, border controls are carried out by customs authorities. However, customs officials usually do not have the technical expertise to decide on compliance with the applicable EU product legislation: for this, they have to refer suspicious cases identified in their controls to the competent market surveillance authorities. Border controls therefore require close cooperation between customs and market surveillance authorities in order to be effective. When the border authority is a market surveillance authority, it can carry out its tasks autonomously in its fields of competence and does not have to interact with another authority in order to reach conclusions.
7.5.2.   
Principles of border controls


Border authorities perform controls on imported products regardless of their means of transport (sea, air, road, rail, inland waters) or shipment (containers, small packages and any other form). They perform such controls on the basis of risk analysis in accordance with the Union Customs Code. (304) Where relevant, they should also consider the risk-based approach required from market surveillance authorities by Article 11(3) of Regulation (EU) 2019/1020 (Article 25(3) of Regulation (EU) 2019/1020). Border authorities and market surveillance authorities should regularly exchange risk information in order to increase the effectiveness of their risk analysis and the risk-based approach. In particular, market surveillance authorities are required to provide border authorities with information on the categories of products and economic operators that are more often found to be non-compliant (Article 25(5) of Regulation (EU) 2019/1020). This information should be regularly updated.
Border authorities may perform documentary or physical checks, and may also carry out laboratory checks. They may always contact the declarant or another relevant economic operator to request documents or additional information. The conditions for detailed controls, such as laboratory checks, can be agreed between customs authorities and market surveillance authorities, taking into account the working method they consider most efficient. Customs and market surveillance authorities should in any case work in close cooperation with each other.
The release for free circulation shall not be deemed to be proof of conformity with Union law (Article 27 of Regulation (EU) 2019/1020), since such a release does not necessarily include a complete check of compliance. Thus, even if released for free circulation, products may later be checked by market surveillance authorities and can be found non-compliant.
7.5.3.   
Applicable procedures


7.5.3.1.   Suspension by border authorities of products suspected to be non-compliant or to present serious risk and notification to market surveillance authorities

When a product imported from a third country has been selected for control and the border authorities have reasons to believe that it is non-compliant – for instance in relation to the essential requirements or the required accompanying documentation, marking, labelling or other information – or that it presents a serious risk, they have to suspend the release for free circulation and notify the relevant market surveillance authority thereof (Article 26(1) and (2) of Regulation (EU) 2019/1020). The border authorities should share this information in an agreed form, providing the market surveillance authority with the necessary information to assess the compliance of the product. Regulation (EU) 2019/1020 has tasked the Commission to develop an IT solution linking existing national customs systems and ICSMS, which should ultimately facilitate the communication and handling of such cases.
Market surveillance authorities must also, at their own initiative, ask border authorities to suspend the release for free circulation if they have reasonable grounds to believe that a product arriving at customs is non-compliant or presents a serious risk (Article 26(3) of Regulation (EU) 2019/1020).
7.5.3.2.   Decision by market surveillance authorities

Market surveillance authorities have four working days to react to the notification of a suspension. If they do not react within this timeframe, border authorities will have to release the product for free circulation, provided that other requirements and formalities related to such release have been fulfilled (Article 27 of Regulation (EU) 2019/1020). This does not mean that the entire procedure from the suspension until the decision on release for free circulation should be completed within four working days. It should be handled without delay to avoid creating barriers for legitimate trade, but the suspension of release can be maintained for the time required by the market surveillance authority to carry out appropriate verifications on the products and allow them to take the final decision on compliance. Market surveillance authorities should ensure that the free movement of products is not restricted to any extent greater than necessary or allowed under any relevant EU legislation. To that end, market surveillance authorities should perform their activities regarding products originating from third countries - including the interaction with the relevant economic operators - with the same methodologies and celerity as for products originating from the EU.
If the market surveillance authority is unable to make a final decision on compliance within the four working days, it should notify the border authorities within this timeframe that its final decision on the product is pending and request to maintain the suspension of release for free circulation. In this event, the release for free circulation remains suspended until the market surveillance authority has made a final decision. The products will remain under customs supervision even if they are allowed to be stored at another place approved by customs.
7.5.3.3.   Follow-up by border authorities

When market surveillance authorities inform the border authorities that they consider that product can be released for free circulation, border authorities must proceed to do so, provided that other requirements and formalities related to such release have been fulfilled (Article 27 of Regulation (EU) 2019/1020). If any further corrective measures are deemed necessary, the market surveillance authority should follow up on this.
When market surveillance authorities find that the product is not compliant or presents a serious risk, they have to require the border authorities not to release the product for free circulation (Article 28(1) and (2) of Regulation (EU) 2019/1020). They must indicate whether this is because the product presents a serious risk or whether it is otherwise non-compliant with EU law. Border authorities have to enter this information in the customs data-processing system and, where appropriate, on physical documentation accompanying the product such as an invoice, as follows:






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‘Dangerous product – release for free circulation not authorised – Regulation (EU) 2019/1020’; or










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‘Product not in conformity – release for free circulation not authorised – Regulation (EU) 2019/1020’.




Market surveillance authorities are required to enter the case in ICSMS, including the information that the case originates from border controls and the nature of the non-compliance (serious risk or other non-conformity). If the case highlighted a serious risk, they must also introduce the appropriate notification in RAPEX (Article 20 of Regulation (EU) 2019/1020). Market surveillance authorities should further take measures to prohibit the placing on the market of the product to prevent other shipments of the product from entering the EU market.
Border authorities may decide to destroy the non-compliant products at the cost of the declarant where they present a risk to health and safety of end users (Article 28(4) of Regulation (EU) 2019/1020). Depending on the organisational structure, they may do so at the request of the market surveillance authorities.
Border authorities may also allow the product to be placed into a customs procedure other than release for free circulation, if the market surveillance authorities do not object to this. In such case, the above-mentioned notice ‘Dangerous product… etc.’ or ‘Product not in conformity… etc.’ must be included in the documents used in connection with that procedure (Article 28(3) of Regulation (EU) 2019/1020). The border authorities may allow actions to ensure that the product will be modified, under relevant customs procedures and in an appropriate manner, thus enabling its further release for free circulation.
In some cases, the place where the product is declared for free circulation may be different from the point of entry of the product. This does not preclude the competent authorities from carrying out appropriate controls at the point of entry. If they do so, they should provide the customs authorities at the place of declaration with adequate information on their controls and findings.
Compliance with EU product rules does not apply to non-EU products that are not declared for free circulation, such as those in transit and placed in free zones and free warehouses. Information can however become available that these products do not comply with the relevant EU rules or present a serious risk. Such information should be communicated to the relevant authorities to avoid that such products could be placed on the EU market at a later stage.
7.6.   Cooperation among Member States and with the European Commission

In order to be effective, the market surveillance effort should be uniform across the Union. This is all the more important considering that each point of the Union’s external border constitutes an access point for a great quantity of products from third countries. If market surveillance is ‘softer’ in some parts of the Union than others, weak spots are created which threaten the public interest and create unfair trade conditions. Consequently, there must be effective market surveillance along the entire length of the Union’s external borders.
Cooperation and coordination of action among national authorities is indispensable to obtain effective and consistent surveillance of the Internal Market. The EU legal framework provides a number of tools to achieve this goal. Action against products found to be non-compliant has to be generally undertaken throughout the EU, with detailed procedures in the case of certain Union harmonisation legislation which includes a safeguard clause. Mutual assistance based on Regulation (EU) 2019/1020 allows authorities to enforce a request of information vis-à-vis economic operators located in another Member State, and in special cases also enforcement measures. The EU Product Compliance Network, administrative cooperation groups (ADCOs), the ICSMS database, RAPEX and the coordinated activities on safety and conformity of products constitute essential tools to exchange information and optimise work sharing among authorities.
Cooperation between national authorities responsible for border controls is also key to ensure an equal protection of the EU border. These authorities are required to share risk information via the customs risk management system (CRMS) to ensure that any risk or irregularity identified at one point of the border is instantly communicated to any other point of the border, hence ensuring effective protection of the borders against non-compliant or unsafe goods through intense cooperation in line with Art 46(5) and 47(2) of the Union Customs Code.
7.6.1.   
EU-wide action on non-compliance













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Products deemed non-compliant in one Member State are generally presumed to be non-compliant across the EU.











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Action against products found to be non-compliant has to be generally undertaken throughout the EU.











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Mechanisms exist in case of disagreements between market surveillance authorities on compliance.









When a market surveillance authority establishes that a product is non-compliant, it is generally considered non-compliant throughout the EU, unless a relevant market surveillance authority in another Member State concluded the contrary on the basis of its own investigation or the safeguard procedure (see point 7.6.2) of the applicable Union harmonisation legislation specifies otherwise (Article 11(9) of Regulation (EU) 2019/1020). Market surveillance authorities in the other Member States will normally not have to undertake action, because the economic operator concerned has to take corrective action throughout the EU (Article R31(3) of Annex I to Decision No 768/2008). An exception to this is the case where measures are taken against dangerous products, where all relevant market surveillance authorities across the EU have an obligation to ensure that the serious risk is eliminated (Article R31(8) of Annex I to Decision No 768/2008). Market surveillance authorities are informed of such cases through RAPEX (see Section 7.6.4). Another exception is the case where the economic operator concerned does not undertake corrective action within the period indicated by the market surveillance authority that required it to do so. Market surveillance authorities can obtain such information from ICSMS, through safeguard clause notifications (see Section 7.6.2) and, for legislation that does not contain such safeguard clause, by monitoring the case investigations for their product sector.
Market surveillance authorities can rely on information from other market surveillance authorities (Article 11(6) of Regulation (EU) 2019/1020). However, market surveillance authorities are in all cases entitled to conduct their own investigation, taking into account any information received from economic operators if they consider it relevant. If they come to a different conclusion, i.e. they do not find the product to be non-compliant, then they can object in the safeguard notification for the legislation that includes such procedure. For such cases, see Section 7.6.2. In the case of other legislation or where the safeguard clause is not applicable, market surveillance authorities do not have to undertake action if they do not find the product to be non-compliant on the basis of its own investigation.
7.6.2.   
The application of the safeguard clause













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A large part of Union harmonisation legislation has a detailed procedure that applies across the EU when Member States adopt compulsory restrictive measures.











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The mechanism allows other Member States and the Commission to object. It also allows the Commission to take a position on the national measures restricting the free movement of products with a view to ensuring the functioning of the internal market.









The safeguard clause procedure, based on Article 114(10) TFEU and included in a large part of sectoral Union harmonisation legislation, requires Member States to take provisional measures in relation to products presenting a risk to health and safety or other aspects of public interests protection and obliges them to notify those measures to the Commission and other Member States. The safeguard clause procedure is designed to provide a means to notify all national market surveillance authorities and the Commission about measures taken on products presenting a risk to health and safety or other aspects of public interests protection, including the grounds for the decision, and, accordingly, to have the necessary restrictions extended to all Member States, so as to ensure an equivalent level of protection throughout the EU. Furthermore, it allows other Member States and the Commission to take a position on the national measures restricting the free movement of products with a view to ensuring the functioning of the internal market.
It is to be noted that the safeguard procedure is different from RAPEX notification procedure because of their different notification criteria and different methods of application. The safeguard clause procedures under the Union harmonisation legislation apply independently from RAPEX. Accordingly, RAPEX does not necessarily have to come into play before the safeguard clause procedure is applied. However, the safeguard clause procedure has to be applied, in addition to RAPEX, when a Member State takes a decision to prohibit or restrict the free movement of products covered by Union harmonisation legislation on the basis of a danger or other serious risk presented by the product.
7.6.2.1.   Compulsory restrictive measure taken

The application of the safeguard clause requires that the national market surveillance authority takes one or more compulsory measures to restrict or forbid the making available on the market and, possibly, the putting into service of the product, or has it withdrawn from the market where the relevant economic operator does not take adequate corrective action himself. The contents of the decision should relate to all products belonging to the same type/model, batch or series. It must also have binding legal effect: it is followed by sanctions, if not respected, and can be subject to an appeal procedure. Court decisions, which restrict the free movement of CE marked product within the scope of the relevant Union harmonisation legislation, do not invoke the safeguard clause. However, where administrative proceedings initiated by the surveillance authority must be, according to the national law, confirmed by a court, such court decisions are not excluded from the safeguard clause procedure.
The findings that justify the national measure are established either by the market surveillance authority on its own initiative or based on information received from a third party (such as consumers, competitors, consumer organisations, labour inspectorates). Further, the national measure must be based on evidence (for example tests or examinations) that constitutes sufficient proof of errors in the product design or the manufacture to indicate a foreseeable potential or actual danger or other substantial non-compliance, even when the products are correctly constructed, installed, maintained and used in accordance with their intended purpose or in a reasonably foreseeable way. There is a grey zone between correct and incorrect maintenance and use, and it can be considered that, to a certain extent, products should be safe, even if maintained and used for their intended purpose in an incorrect way that can reasonably be expected. In evaluating this, the data supplied by the manufacturer on the labelling, in the instructions, in the user’s manual or in promotion materials are to be taken into consideration.
The reason for taking restrictive measures may result, for instance, from differences or failures in the application of essential requirements, incorrect application of harmonised standards or shortcomings in them. The surveillance authority can add or specify other motives (for example failure to comply with good engineering practice) when invoking the safeguard clause, provided that they are directly linked with these three reasons.
Where non-compliance with harmonised standards that would imply a presumption of conformity is established, the manufacturer, or the authorised representative, must be requested to provide evidence about compliance with essential requirements. The decision of the market surveillance authority to take measures must always be based on an established non-compliance with the essential requirements.
The measures taken by authorities have to be proportionate with the seriousness of the risk and the non-compliance of the product and have to be notified to the Commission.
7.6.2.2.   Notification to the Commission and other Member States

As soon as a market surveillance authority restricts or forbids the free movement of a product in such way that the safeguard clause is applied, the Member State must notify (305) without delay the Commission and the other Member States of the provisional measures, indicating the reasons and justification for the decision.
The information has to include all available details, in particular:






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name and address of the manufacturer, the authorised representative, and in addition – if necessary – the name and address of the importer or other person responsible for making the product available on the market;










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the data necessary for the identification of the product concerned and the origin of the product;










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the nature of the alleged non-compliance and the risk involved;










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the nature and duration of the national measures taken;










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a reference to the Union harmonisation legislation, and in particular to the essential requirements, against which the non-compliance has been established;










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An indication of whether the non-compliance is due to either:






a)


failure of the product to meet requirements relating to the health or safety of persons or to other aspects of public interest protection; or










b)


shortcomings in the harmonised standards conferring a presumption of conformity.














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the arguments put forward by the relevant economic operator; and










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a copy of the decision taken by the Member State authorities.




If possible, the notification should also include:






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information on the supply chain of the product;










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a comprehensive assessment and evidence to justify the measure (for example harmonised standards or other technical specifications used by the authority, the test reports and identification of the testing laboratory);










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a copy of the declaration of conformity; and










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the name and number of any notified body that intervened in the conformity assessment procedure, if applicable.




7.6.2.3.   Management of the safeguard procedures by the Commission

Where objections are raised against a measure taken by a Member State (306), or where the Commission considers a national measure to be contrary to Union harmonisation legislation, the Commission must without delay enter into consultation with the Member States and the relevant economic operator or operators and must evaluate the national measure. On the basis of the results of this evaluation, the Commission decides whether the national measure is justified or not.
The Commission addresses its decision to all Member States and immediately communicates it to them and the relevant economic operator or operators.
If the national measure is considered justified, all Member States must take the measures necessary to ensure that the non-compliant product is withdrawn from their market, and must inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned must withdraw the measure.
Member States other than the Member State initiating the procedure must without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the notified national measure, of their objections. Member States must ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from their market, without delay.
Where, within the period of time of receipt of the information specified in the Union harmonisation legislation, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure should be deemed justified.
Whether the action taken by the Member State is considered justified or not, in either case, the Commission keeps the Member States informed of the progress and the results of the procedure.
Once the decision is taken by the Commission, it can be legally challenged by Member States on the basis of Article 263 TFEU. The economic operator directly concerned by the decision may also challenge it on the basis of Article 263 TFEU.
If the initiating Member State does not withdraw the measure in case of non-justification, in this case, the Commission will consider initiating the infringement procedure provided for by Article 258 TFEU.
7.6.2.4.   Compliant products presenting a risk

In addition to the safeguard clause procedures allowing for market surveillance measures against non-compliant products to be applied consistently across the Union, Union harmonisation legislation generally foresees the possibility of, and requires for action to be taken against, products which are compliant with the essential requirements but which still present a risk.
In particular, where the market surveillance authorities find that a product, while being compliant with the applicable Union harmonisation legislation, presents a risk to the health or safety of persons or to other aspects of public interest protection, they must take measures to require the economic operator to ensure that the product no longer presents that risk, to recall it or to withdraw it, depending on the risk. As soon as a market surveillance authority restricts or forbids the free movement of a product in such way, the Member State must notify (307) without delay the Commission and the other Member States of the provisional measures, indicating the reasons and justification for the decision.
The information has to include all available details, in particular:






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name and address of the manufacturer, the authorised representative, and in addition – if necessary – the name and address of the importer or other person responsible for making the product available on the market;










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the data necessary for the identification of the product concerned and the origin of the product;










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the nature of the risk involved;










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the nature and duration of the national measures taken;










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a reference to the Union harmonisation legislation;










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the arguments put forward by the relevant economic operator;










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information on the supply chain of the product; and










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a copy of the decision taken by the Member State authorities.




If possible, the notification should also include:






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a comprehensive assessment and evidence to justify the measure (for example the test reports and identification of the testing laboratory);










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a copy of the declaration of conformity; and










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the name and number of any notified body that intervened in the conformity assessment procedure, if applicable.




Where a market surveillance authority adopts such measures against products presenting a risk, the Commission is required without delay to enter into consultation with the Member States and the relevant economic operator or operators and must evaluate the national measure. On the basis of the results of this evaluation, the Commission decides whether the national measure is justified or not.
The Commission addresses its decision to all Member States and immediately communicates it to them and the relevant economic operator or operators. If the measure is considered justified, the Commission may also consider adopting proposals to revise the legislation.
7.6.3.   
Mutual assistance, Administrative Cooperation and the EU product compliance network













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The cooperation between national market surveillance authorities is indispensable for the success of the market surveillance policy of the Union as a whole.











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Mutual assistance, Administrative Cooperation groups (ADCOs) and the EU Product Compliance Network constitute essential tools.











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The cooperation of Member States is facilitated by the use of specific IT platforms for exchange of information.









Technical harmonisation has created a single market, where products move across national borders, while market surveillance is carried out on a national basis. This requires smooth cooperation to ensure uniform and efficient enforcement of Union legislation in all Member States. The obligation to cooperate is in line with Article 20 of the Treaty on European Union (TEU) which states that Member States must take all appropriate measures to fulfil their obligations. Detailed provisions on cooperation are included in Regulation (EU) 2019/1020, in particular on bilateral mutual assistance, multilateral sectorial administrative cooperation and by the establishment of an EU Product Compliance Network that facilitates EU-wide cross-sectorial cooperation, to address common challenges and to spread good surveillance practice and techniques across the Union.
Administrative cooperation calls for mutual trust and transparency between national surveillance authorities. Member States and the Commission need to be informed about the national authorities in charge of market surveillance for the different product sectors and about the compliance checks they carry out. Such information is shared through the Information and Communication System for Market Surveillance (ICSMS) (308).
Information exchanged between national surveillance authorities has to be treated according to the principles of confidentiality and of professional and commercial secrecy. Further, personal data shall be protected in accordance with EU and national law. Where a Member State has rules permitting free access by persons to information held by surveillance authorities, this fact must be revealed at the time of the request to another surveillance authority, or during the exchange of information if no such request occurs. If the sending authority indicates that the information involves matters of professional or commercial confidentiality, the receiving authority should ensure that this can be provided for. Otherwise the sending authority is entitled to withhold the information.
7.6.3.1.   Mutual assistance

Cross-border mutual assistance helps completing investigation and enforcement actions in cases where an economic operator located in another Member State than the investigating authority does not cooperate. Articles 22 to 24 of Regulation (EU) 2019/1020 specify how such mutual assistance is requested and how it has to be followed up on. A distinction is made between request for information and requests for enforcement measures. All requests for assistance are made through ICSMS.
Requests for information concern cases where an investigation into whether a product is compliant or not was started, and where the market surveillance authority needs compliance documentation from an economic operator for this investigation. The market surveillance authority in question should first itself request the documentation from the economic operator in the other Member State. Only when that economic operator does not provide the requested documentation, can a request for mutual assistance be made to an authority in that Member State (the ‘requested authority’). The authority that initiated the investigation (‘the applicant authority’) remains responsible for that investigation, unless otherwise agreed between the authorities. The applicant authority should clearly specify what compliance documentation it needs and from which economic operator. The requested authority should without delay contact the economic operator to obtain the information, which should then be passed on to the applicant authority as soon as possible, and in any case within 30 calendar days.
Requests for enforcement measures are meant only for exceptional cases. When a market surveillance authority establishes a non-compliance, it should itself request the relevant economic operator to take corrective action and when that economic operator does not comply, the authority should take measures and inform other Member States so that they also take measures if the product is on their market (see Sections 7.6.1 and 7.6.2). Requests for enforcement measures by an authority in another Member State are meant only for cases where these procedures do not resolve a non-compliance. For example, in the case where an economic operator in the another Member State does not cooperate and keeps offering the product to end-users, but not in the Member State where it resides and thus the authorities of that Member States would normally not undertake action (as the product is not on their market).
Requests for enforcement measures should include a justification why the measures are necessary. The requested authority may decide on the most appropriate measures to end the non-compliance. This can include fines. The requested authority may make use of powers that require recourse to other public authorities or application to competent courts. Member States have to make sure that there are no national legal barriers that would prevent them from taking appropriate measures in order comply with Article 23 of Regulation (EU) 2019/1020. The requested authority should take action without delay and inform the applicant authority of the measures taken or intended to be taken.
Mutual assistance requests for information and for enforcement can be refused in certain circumstances, which are specified in Articles 22 and 23 of Regulation (EU) 2019/1020. A request for information can be refused if the applicant authority has not made it clear why the information is necessary. A request for enforcement measures can be refused if the applicant authority has not provided sufficient information to follow it up. A request for enforcement measures can also be refused if the requested authority disagrees that there is a non-compliance. Further, both types of requests can be refused if it overburdens the requested authority’s own activities. However, authorities should act in good faith and, as a general principle, accept requests for mutual assistance, in particular those concerning request for obtaining the EU declaration of conformity, declaration of performance and technical documentation. Refusals of request have to be justified. The Commission will monitor the operation of the mutual assistance mechanism and will identify areas where the refusals were not justified.
7.6.3.2.   Administrative cooperation groups

Cooperation between market surveillance authorities of the Member States regarding products covered by Union harmonisation legislation takes place in administrative cooperation groups (ADCOs) established for sectors of Union harmonisation legislation. Many of the groups cover one piece of Union harmonisation legislation and others cover a few closely related pieces of Union harmonisation legislation. Regulation (EU) 2019/1020 specifies their tasks in Article 32. They facilitate the uniform application of Union harmonisation legislation, e.g. by discussing and resolving divergent application of Union harmonisation legislation. They further carry out a range of other cooperation activities, including in many cases the planning and carrying out of joint actions. They also provide input to the cooperation in the EU Product Compliance Network (see next point).
Some groups use a different name than ADCO sometimes with their own legal basis in Union harmonisation legislation, with their tasks specified therein. They operated on the basis of that legislation, while also cooperating in the EU Product Compliance Network in the same way as ADCOs do.
7.6.3.3.   EU Product Compliance Network

Article 29 of Regulation (EU) 2019/1020 established the Union Product Compliance Network for cooperation on market surveillance across the EU and across the different product sectors. The Network is composed of representatives of the Member States, including in particular their single liaison offices, the chairs of the ADCOs and representatives of the Commission. The Network is a platform for structured coordination and cooperation on market surveillance, in particular priority setting and addressing horizontal cross-sectorial aspects of market surveillance. It works on the basis of a work programme, which can be regularly adapted in order to address new challenges in market surveillance. The Network closely cooperates with the Consumer Safety Network provided for by Article 10 of Directive 2001/95/EC on product safety related topics.
7.6.4.   
Rapid Alert System for non-food products presenting a risk (RAPEX)








The Rapid Alert System used for non-food products allows 30 participating countries (all EEA countries) and the European Commission to exchange information on products presenting a risk to health and safety or other protected interests and on the measures taken by these countries to do away with that risk.





Article 12 of the GPSD provides a legal basis for a general and horizontal system for the rapid exchange of information on serious risks arising from the use of products (RAPEX).
The Rapid Alert System covers consumer and professional products (309). It is applicable to non-harmonised products and products covered by the Union harmonisation legislation alike (310).
The Rapid Alert System works according to the detailed procedures laid down in Annex II to the GPSD and in the Rapid Alert System guidelines (311).
The scope of the Rapid Alert System includes risks other than those affecting health and safety (i.e. risks for the environment and in the work place, security risks) and also products intended for professional (as opposed to consumer) use. Member States should ensure that corrective measures are adopted towards dangerous products, such as their withdrawal or, where there is no other effective means available to eliminate the risk, their recall, or that their being made available on their market is prohibited, and that the Commission is informed without delay of the corrective measures, both voluntary (taken by economic operators) and compulsory (ordered by authorities), through the Rapid Alert System under Article 20 of Regulation (EU) 2019/1020.
The Rapid Alert System procedure is as follows:






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When a product (e.g. a toy, a childcare article or a household appliance) is found, for instance, to be dangerous, the competent national market surveillance authority takes appropriate action to eliminate the risk. It can withdraw the product from the market, recall it from consumers or issue warnings. Economic operators can take such measures also voluntarily which has to be reported by the competent authorities as well. The National Contact Point then notifies the European Commission (through the IT application of the system) about the product, the risks it poses and the measures taken by the authority or the economic operator to prevent risks and accidents.










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The Commission checks that the notification meets the criteria laid down in the Rapid Alert System guidelines and, if so, it disseminates the notification received to the National Contact Points of all other EU and EEA countries. It publishes weekly overviews that include a summary of the measures taken against products posing a risk on the Commission’s Rapid Alert System website (312).










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The National Contact Points in each EU and EEA country coordinate the work of the market surveillance authorities at national level that must ensure swift follow up on newly notified measures and implement measures to mitigate the identified risks such as requiring that the product is withdrawn from the market, by recalling it from consumers or by issuing warnings.




The safeguard clause procedures under the Union harmonisation legislation apply in addition to the Rapid Alert System. Accordingly, the Rapid Alert System does not necessarily have to come into play before the safeguard clause procedure is applied. However, the safeguard clause procedure has to be applied, in addition to the Rapid Alert System, when the Member State takes a decision to permanently prohibit or restrict the free movement of CE marked products on the basis of a danger or other serious risk presented by the product.
7.6.5.   
ICSMS













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ICSMS (Information and Communication System for Market Surveillance) is an IT tool that provides for a comprehensive communication platform between all the market surveillance authorities.











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ICSMS consists of an internal (accessible only to market surveillance authorities) and a public area.











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Regulation (EU) 2019/1020 on market surveillance and Regulation (EU) 2019/515 on mutual recognition provide for the use of ICSMS.









7.6.5.1.   Role

While ICSMS was an important aspect in the implementation of Regulation (EC) No 765/2008, under Regulation (EU) 2019/1020 on market surveillance and Regulation (EU) 2019/515 on mutual recognition it is even more the case: ICSMS becomes the digital backbone of these Regulations.
Both Regulations provide for the obligations of the authorities to make use of ICSMS. In addition, Regulation (EU) 2019/1020 on market surveillance lays down the rules for its use.
ICSMS offers fast and efficient communication means for market surveillance authorities to exchange information within a short space of time. ICSMS allows information on products (compliance status, test results, product identification data, photographs, economic operator information, risk assessments, accident information, information on measures taken by surveillance authorities etc.) which have been investigated by a market surveillance authority to be stored and quickly and efficiently shared between authorities.
The aim is not only to avoid cases where a non-compliant product taken off the market in one country to be on sale for a long time in another country but mainly to have a market surveillance policy tool that allows to establish a co-operation mechanism among authorities.
While being aware of the fact that the mere reliable exchange of information is crucial for the market surveillance, it must be acknowledged that the added value of ICSMS stems from its capacity to be the platform for the implementation of the European market surveillance policy.
In this respect, whenever a national authority wants to exchange information about a product under investigation with other authorities in order to share resources (e.g. for product checks), carry out common actions or consult other authorities, it should input into ICSMS the relevant information. This should be done as early as possible and certainly well before the decision to adopt measures for products found to present a risk. E.g. if a national authority cannot determine the level of the risk presented by a relevant product and carries out investigations, it should use ICSMS in order to communicate with the competent authorities of the other Member States.
ICSMS is not limited only to non-compliant products, but it gives information also regarding other products checked by authorities even if the result of the checks would be that no non-compliances have been found. This helps authorities avoiding any double (or multiple) checking of products. As a minimum, market surveillance authorities have to enter into ICSMS information on all products for which an in-depth check has been carried out (Article 34(4) of Regulation (EU) 2019/1020) This covers not only products for which laboratory tests are carried out, but also those for which simpler checks are carried out, though it is not required to include those where only brief visual checks were carried out. As a guideline, checks which are individually documented should be entered into ICSMS (313). Other checks may, however, also be entered into ICSMS.
Thus, the ultimate role of ICSMS is to help the European Union to fulfil one of its major political objectives; i.e. to ensure reliability and coherence in the implementation and enforcement of the European legislation) in order for operators and citizens to benefit from the original intention of full access to the Internal Market.
In particular ICSMS helps market surveillance authorities to:






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proceed to quick and in-time exchange of information on market surveillance measures;










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coordinate their activities and inspections more effectively, especially by focusing on products which have not been inspected or tested yet;










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share resources and have thus more time to concentrate on other products which have yet to be tested;










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share experience on complex product compliance assessment cases;










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carry out wide-scale market interventions wherever products of a dubious nature are concerned using the latest information and avoid thus duplicate and multiple inspections;










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generate statistical data;










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launch the safeguard clause notifications (for some Directives/Regulations)










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send relevant data to RAPEX in order for RAPEX contact points to trigger the process for launching RAPEX notifications (314);










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elaborate best practices;










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ensure that market surveillance is efficient and of even rigour in all Member States and avoid thus distortion to competition;










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establish an encyclopaedia of EU market surveillance intelligence; and










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request assistance from authorities in other Member States.




7.6.5.2.   Structure

The internal area is destined for market surveillance authorities, single liaison offices, customs authorities and the Commission. It contains all information available (product description, test results, measures taken etc.). Only ICSMS account holders may access this area.
The public area is destined for consumers, users and manufacturers. The information which is visible to the public provides only the data, which reference the product and its non-compliance and not any internal documents (i.e. information exchange between authority and importer/manufacturer).
ICSMS enables specific searches for non-compliant products. Confidentiality aspects are protected by a system of access authorisations.
Each market surveillance authority can input data about investigated products, which are not already in the database and add information (e.g. additional tests results, measures taken) to an already existing product information file.
The Commission ensures the proper functioning of ICSMS. The use of ICSMS is free of charge.
7.6.6.   
Medical devices: vigilance system








A specific vigilance system applies in the case of medical devices.





Risks posed by medical devices have necessitated a comprehensive monitoring system whereby all serious product incidents will be reported (315). The medical devices vigilance system applies to all incidents (316) which directly or indirectly might have led to, the death or a temporary or permanent serious deterioration of a patient’s, user, or other person’s state of health or a serious public health threat, and which resulted from:






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any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features;










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any inadequacy in the labelling or the instructions for use; or










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any technical or medical reason in relation to the characteristics or performance of a device, and which leads the manufacturer to systematically recall all devices of the same type.




The manufacturer is responsible for activating the vigilance system and must, accordingly, inform the surveillance authority about incidents that invoke it. After the notification, the manufacturer is obliged to make investigations, send a report to the surveillance authority and consider, in collaboration with the authority, what action should be taken.
The manufacturer’s notification is followed by an assessment carried out by the surveillance authority, if possible together with the manufacturer. After the assessment, the authority must immediately inform the Commission, and the other Member States, of the incidents for which relevant measures have been taken or are contemplated. The Commission may then take any steps to coordinate, facilitate and support measures taken by the national surveillance authorities when dealing with the same type of incidents, or, if necessary, take measures at Union level (for example envisaging the re-classification of the device). A European database containing, among other information, data obtained in accordance with the vigilance system is managed by the Commission and made accessible to the competent authorities. The vigilance system is different from the safeguard clause procedure, since it requires notification even if the manufacturer takes the necessary measures on a voluntary basis. Nevertheless, when applying the vigilance system the surveillance authority is also obliged to adopt a restrictive measure vis-à-vis non-compliant CE marked products, if the conditions for invoking the safeguard clause apply and, accordingly, notify this measure following the safeguard clause procedure. However, the vigilance system does not necessarily have to come into play before the safeguard clause procedure is applied.
8.   FREE MOVEMENT OF PRODUCTS WITHIN THE EU (317)

8.1.   Free movement clause

The objective of eliminating trade barriers among Member States and of strengthening the free movement of products is stated by a free movement clause, inserted in Union harmonisation legislation, which guarantees the free movement of products complying with the legislation. Free movement clauses are provisions inserted in EU legislative acts, which expressly prevent the Member States from taking more restrictive measures on a matter, if that matter fulfils the requirements of the law in question. Therefore, Member States cannot impede the making available on the market of a product which complies with all the provisions of sectoral harmonisation legislation.
The conformity to all the obligations incumbent on manufacturers by virtue of Union harmonisation legislation is symbolised by the CE marking. Member States must presume that products bearing the CE marking comply with all the provisions of the applicable legislation providing for its affixing. Accordingly, Member States may not prohibit, restrict or impede the making available on the market in their territory of products bearing the CE marking, unless the provisions relating to CE marking are incorrectly applied.
8.2.   Limits and restrictions

The Union harmonisation legislation is designed to ensure free movement of products that comply with the high level of protection laid down in the applicable legislation. Therefore, Member States may not prohibit, restrict or impede the making available of such products for the aspects covered by the applicable Union harmonisation legislation. However, Member States are allowed to maintain or adopt, in compliance with the Treaty (in particular Articles 34 and 36 TFEU), additional national provisions regarding the use of particular products which are intended for the protection of workers or other users, or the environment. Such national provisions may neither require modification of a product manufactured in accordance with the provisions of the applicable legislation, nor influence the conditions for making it available.
A limitation to the free movement of product might be imposed in the case of non-compliance of a product with the essential or other legal requirements. Besides that, it may be the case that products complying with the requirements of harmonised legislation present, nonetheless, a risk to the health or safety of persons or to other aspects of public interest protection. In this case, Member States must require the relevant economic operator to take corrective actions. It is possible, therefore, to limit the free movement of a product not only in case of non-compliance of the product with the requirements set up by the relevant legislation but also in the case of compliance when the essential or other requirements do not entirely cover all of the risks related to the product. (318)

9.   INTERNATIONAL ASPECTS OF THE EU LEGISLATION ON PRODUCTS

In its relationships with third countries, the EU, among other things, endeavours to promote international trade in regulated products. Conditions for open trade include compatibility of approach, coherence of regulations and standards, transparency of rules, appropriate levels and means of regulation, impartiality in certification, compatibility of market surveillance measures and supervision practices, and an appropriate level of technical and administrative infrastructure.
Accordingly, depending on the status of the above conditions, a broad variety of measures can be applied in order to facilitate trade. The expansion of the single market of products is pursued through several international legal instruments that enable the achievement of appropriate levels of cooperation, convergence or harmonisation of legislation and thus facilitate the free movement of goods. These instruments include:






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full integration of the EEA EFTA countries in the internal market by virtue of the EEA agreement (319);










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alignment of the legislative system and horizontal quality infrastructure of the Candidate countries with those of the EU. Candidate countries and potential candidates also have the possibility to join the EU quality infrastructure bodies, such as the relevant European Standardisation Organisations;










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similar alignment by interested Eastern and Mediterranean Neighbouring countries by conclusion of bilateral Agreements on conformity assessment and acceptance of industrial products (ACAAs);










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conclusion of bilateral (inter-governmental) Mutual Recognition Agreements (MRAs) for conformity assessment, certificates and marking, which are intended to reduce the costs of testing and certification in other markets;










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conclusion of a specific Protocol on conformity assessment in the framework of a Free Trade Agreement (FTA) negotiated with a third country;










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reliance on the WTO Agreement on Technical Barriers to Trade (320); and










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finally, alignment of standards between CEN and ISO - International Organization for Standards via the Vienna Agreement and CENELEC and IEC – International Electrotechnical Commission via the Frankfurt Agreement.




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







Agreements on Conformity Assessment and Acceptance of industrial products are established between the Union and EU Neighbouring countries.





The European Union has always been at the forefront of support for international cooperation regarding the areas of technical regulations, standards, conformity assessment, market surveillance and the elimination of technical barriers to trade for products. Within the framework of the enlargement and the European Neighbourhood Policy, the European Commission has made clear its intention to intensify cooperation with the EU’s eastern and southern neighbours in the areas of trade, market access and regulatory structures.
The use of the Union system of standardisation and conformity assessment by third countries is designed to facilitate trade and market access in both directions.
Agreements on Conformity Assessment and Acceptance of industrial products are intended to be established between the Union and EU Neighbouring countries (Mediterranean – Algeria, Egypt, Israel, Jordan, Lebanon, Morocco, Palestinian Authority, Tunisia, - and Eastern – Armenia, Azerbaijan, Belarus, Georgia, Moldova, Ukraine). They are also available to interested countries that seek full membership of the EU.
This mutual recognition of equivalence in technical regulation, standardisation and conformity assessment on which these agreements are based, operates on the basis of the EU acquis that has been transposed by the partner country, in the same way as it would apply to products placed on the market of a Member State. It allows industrial products covered by the agreements and attested as compliant with the procedures in the European Union to be placed on the market of the partner country without having to undergo any further approval procedures, and vice versa.
An Agreement on Conformity Assessment and Acceptance of industrial products (so-called ACAA) requires the prior full alignment of the partner country’s legal framework with EU legislation and standards and the upgrading of the implementing horizontal infrastructure in line with the model of the EU system, in relation to standardisation, accreditation, conformity assessment, metrology and market surveillance.
ACAAs usually consist of a framework agreement and one or more annexes, setting out the products covered, and the means adopted to extend the benefit of trade in that sector. The framework agreement provides for two mechanisms, (a) the recognition of equivalence in technical regulation, standardisation, conformity assessment and market surveillance for industrial products subject to equivalent regulation in Union law and the national law of the partner country, and (b) the mutual acceptance of industrial products that fulfil the requirements to be lawfully placed on the market in one of the Parties in cases where there is no European technical legislation applicable to relevant products. More sectoral annexes can be added successively.
A first ACAA was signed with Malta in February 2004 (321) before Malta’s formal accession to the EU in May 2004. With Israel, a first ACAA on pharmaceutical products entered into force in January 2013. At the time of writing, other Eastern and Mediterranean partners are finalising the preparatory work for launching negotiations in a number of New Approach sectors (electrical products, construction materials, toys, gas appliances, pressure equipment, etc.).
9.2.   Mutual recognition agreements (MRAs)












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Mutual recognition agreements are established between the Union and third countries, which are on a comparable level of technical development and have a compatible approach concerning conformity assessment.











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These agreements are based on the mutual acceptance of certificates, marks of conformity and test reports issued by the conformity assessment bodies of either party in conformity with the legislation of the other party.









9.2.1.   
Main characteristics


One of the instruments to promote international trade of regulated products is the conclusion of mutual recognition agreements (MRAs) on the basis of Article 207 TFEU. MRAs are agreements established between the Union and third countries for the purpose of mutual recognition of conformity assessment of regulated products.
MRAs are designed so that each Party accepts the reports, certificates and marks that are delivered in the partner country in accordance with its own legislation. These are drawn up and issued by bodies that the other Party has designated under the MRA for assessing conformity in the field(s) covered by the MRA. This can be achieved, because MRAs include all the conformity assessment requirements of the Parties necessary to obtain full market access, and the products are evaluated in the country of production against the regulatory requirements of the other Party. These are usually referred to as ‘Traditional MRAs’.
MRAs cover the entire territory of the Parties in order to guarantee the full free movement of products certified to be in conformity, in particular in States with a federal structure.
MRAs apply to one or more categories of products or sectors falling within the regulated field (they are covered by Union harmonisation legislation in force) and, in certain cases, by non-harmonised national law. In principle, MRAs should cover all the industrial products for which the regulations of at least one of the Parties require third party conformity assessment.
MRAs comprise a framework agreement and sectoral annexes. The framework agreement lays down the essential principles of a traditional agreement. Sectoral annexes specify, in particular, the scope and coverage, regulatory requirements, the list of designated conformity assessment bodies, the procedures and authorities responsible for designating these bodies and, if applicable, transitional periods. More sectoral annexes can be added successively.
MRAs are not based on the necessity to mutually accept other Party’s standards or technical regulations, or to consider the legislation of the two Parties as equivalent. They involve only the mutual acceptance of the reports, certificates and marks that are delivered in the partner country in accordance with its own legislation. However, MRAs can pave the way towards a harmonised system of standardisation and certification by the parties. Nevertheless, the two legislations are, as a rule, deemed to ensure a comparable level of protection regarding health, safety, environment or other public interests. Moreover, MRAs increase the transparency of the regulatory systems. Once established, the MRA needs to be maintained, for example, by keeping lists of recognised certification bodies, and the standards or rules against which they must certify.
The benefits of the MRA arise from the removal of duplicated inspection or certification. Where a product intended for two markets may still have to be assessed twice (when technical requirements or standards are different), the assessment will be cheaper when carried out by the same body. The time to market is reduced since contacts between the manufacturer and the single conformity assessment body, and a single assessment, speed up the process. Even where the underlying regulations are harmonised, for example because they refer to an international standard, the need for recognition of certificates remains, and in such cases, the benefit will be clear: the product is assessed once against the commonly accepted standard instead of twice.
Currently there are MRAs in force with Australia, New Zealand, the United States, Japan and Switzerland. The MRA with Canada (322) has been replaced by the CETA Protocol on the mutual acceptance of the results of conformity assessment (see Section 9.2.4).
The above agreements are concluded in a number of specific sectors, which might vary from one country to another. More details on the agreements can be found at the following address: http://ec.europa.eu/growth/single-market/goods/international-aspects/mutual-recognition-agreements/index_en.htm. The bodies designated under MRAs figure in a dedicated part of NANDO.
9.2.2.   
EU-Swiss MRA


The MRA concluded with Switzerland which entered into force on 1 June 2002 (OJ L114 of 30/04/2002) is an agreement based on the equivalence of legislation of the EU and Switzerland specifically mentioned in the annexes to that agreement (323). It covers the recognition of conformity assessments irrespective of the origin of the products. This type of MRA agreement is usually referred to as an ‘Enhanced MRA’. However, the case of Switzerland remains quite specific.
The provisions of the Agreement and the harmonisation of Swiss technical regulations with those of the EU help market access for EU products to the Swiss market, and vice versa for Swiss products to the EU/EEA market. However there is no customs union between the EU and Switzerland.
According to the Agreement, the Swiss Accreditation Service (SAS) is a full member of European co-operation for Accreditation (EA) and is signatory of all mutual recognition agreements with the EA. In the area of standardisation, Switzerland is full member of CEN, CENELEC and ETSI and participates actively in the work of the European standardisation.
Furthermore, an EU conformity assessment body is allowed to issue certificates in the EU according to EU legislation, which are deemed equivalent to those of Switzerland. The same applies conversely to the Swiss’ conformity assessment bodies. Thus, certificates issued by Swiss conformity assessment bodies accredited by SAS for products covered by the MRA are deemed equivalent to those issued by EU conformity assessment bodies within the scope of application of the MRA and specifically of the EU legislation which is covered by the MRA.
This was only possible because Switzerland has chosen to align its legislation in the sectors covered by the agreement with that of the Union.
The so called ‘Enhanced MRA’ agreement with Switzerland currently covers twenty product sectors: Machinery, Personal Protective Equipment (PPE), Safety of Toys, partially Medical Devices, Gas Appliances and Boilers, Pressure Equipment, Telecommunications Terminal Equipment, Equipment and Protective Systems intended for use in potentially explosive atmosphere (ATEX), Electrical Safety and Electromagnetic Compatibility (EMC), Construction Plant and Equipment, Measuring Instruments and Pre-packages, Motor Vehicles, Agricultural and Forestry Tractors, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) Inspection and Batch Certification, Construction products, Lifts, Biocidal Products, Cableways installations and Explosives for civil use.
A parallel MRA covering exactly the same scope has been concluded between the EEA EFTA States and Switzerland (Annex I to the EFTA Vaduz Convention which entered into force on 1 June 2002).
9.2.3.   
EEA EFTA States: Mutual recognition agreements and Agreements on Conformity Assessment and Acceptance


Mutual Recognition Agreements with third countries concerning conformity assessment for products where the use of a mark is provided for in EU legislation are to be negotiated on the initiative of the EU. Hence, as established in Protocol 12 of EEA, the EU will negotiate on the basis that the third countries concerned will also conclude with the EEA EFTA States parallel Mutual recognition agreements and Agreements on conformity assessment and acceptance equivalent to those to be concluded with the EU. The EEA States shall cooperate in accordance with the general information and consultation procedures set out in the EEA Agreement. If a difference arises in relationships with third countries, it will be dealt with in accordance with the relevant provisions of the EEA Agreement. The system of parallel agreements formally grants the third country concerned the same market access throughout the European Economic Area for products covered by the mutual recognition agreements or Agreements on conformity assessment and acceptance of industrial products. As to the practical implementation of these agreements, common sessions of the Joint Committee meetings with the third country concerned are to be arranged.
9.2.4.   
CETA Protocol on conformity assessment


The Comprehensive Economic and Trade Agreement (‘CETA’) provides for a Protocol on the mutual acceptance of the results of conformity assessment, which aims to make it easier for the EU and Canada to export goods to each other’s market through the mutual recognition of conformity assessment certificates.
The CETA Protocol replaces an earlier Mutual Recognition Agreement between the EU and Canada on conformity assessment (324). The CETA Protocol simplifies the functioning of the former MRA by relying on accreditation, and on closer cooperation between the EU and Canada’s accreditation bodies. In this regard, the CETA Protocol introduces an important novelty by including the possibility for conformity assessment bodies to be accredited to test and certify products for the requirements of the other Party by their own national accreditation body. Hence, the Protocol introduces two pathways to facilitate the mutual recognition of conformity assessment bodies and certificates. The first and preferred way foresees that interested conformity assessment bodies shall seek accreditation directly from the accreditation body established in their territory, provided that the national accreditation body has been previously recognised as competent by the other Party. Second, in case the first option is not available, interested conformity assessment bodies may seek the relevant accreditation by the accreditation body of the other Party. To recognise a conformity assessment body as competent to test and certify products, the other Party will have to previously designate the accredited conformity assessment body and provide the necessary information. The Parties may also raise objections, challenge, and cease to recognise conformity assessment bodies of the other Party. The CETA Protocol establishes a right for Canada to access and use the European Union’s electronic notification system (NANDO) for designation purposes.
The CETA Protocol also extends the scope of cooperation of the prior MRA to the sectors, which are listed in its Annex 1. The Protocol enables the parties to further broaden its scope of application to include additional categories of goods as listed in its Annex 2, after the entry into force of CETA.
On 1 September 2021, the Commission published the Implementation Guide for the Protocol to the CETA Agreement between Canada, the European Union and its Member States regarding the mutual acceptance of the results of conformity assessment 2021/C 351/01 (325). The guide focuses on the steps that the EU and its Member States need to undertake when interested conformity assessment bodies seek recognition to carry out conformity assessment according to EU and Canadian legislative requirements for the EU and Canadian market. The guide also includes information on market surveillance and safeguards.
9.3.   The Trade and Cooperation agreement with the UK

A Trade and Cooperation Agreement (‘TCA’) was agreed between the EU and the UK on 24 December 2020. It is provisionally applicable since 1 January 2021.
The TCA has a specific chapter on Technical barriers to trade (TBT) (Chapter 4). Concerning conformity assessment, both the EU and UK agreed to accept a supplier’s declaration of conformity as proof of compliance with its technical regulations for those product areas where their respective legislation on the date of entry into force of the TCA foresees the use of first-party conformity assessment. Where a Party requires third party conformity assessment as a positive assurance that a product conforms to a technical regulation, it shall use accreditation, as appropriate, as a means to demonstrate technical competence to qualify conformity assessment bodies (Article 93 TBT of the TCA). In this regard, the EU and the UK recognise the valuable role that accreditation operated with authority derived from government and on a non-commercial basis can play in the qualification of conformity assessment bodies. The TCA also calls on both parties to use relevant international standards for accreditation and conformity assessment, and to use relevant international standards as a basis for the standards they develop.
The TCA also contains an article on marking and labelling (Article 95 TBT of the TCA) that aims to address labelling aspects that may render market access more difficult, for example by foreseeing the possibility to accept labelling, including supplementary labelling or corrections to labelling, taking place in customs warehouses or other designated areas in the country of import as an alternative to labelling in the country of origin. The provision on cooperation on market surveillance and non-food product safety and compliance (Article 96 TBT of the TCA) envisages cooperation and information exchange in the area of non-food product safety and compliance. It also contains the basis for: i) an arrangement for the regular exchange of information concerning the safety of non-food products; and ii) an arrangement on the regular exchange of information concerning measures taken on non-compliant non-food products that are not covered by the arrangement concerning the safety of non-food products.
In addition, Article 97 TBT of the TCA provides for technical discussions on draft or proposed technical regulations or conformity assessment procedures. Article 98 TBT of the TCA provides that the Parties shall cooperate in the field of technical regulations, standards and conformity assessment procedures, where it is in their mutual interest, and without prejudice to the autonomy of their own respective decision-making and legal orders.
The TCA is however not a mutual recognition agreement for conformity assessment of the type described in Section 9.2, and it does not provide for the mutual recognition of conformity assessment bodies’ results in the EU and UK markets.
The TCA provides for a good basis for a longstanding partnership between the EU and the UK outside of the EU Single Market.


(1)  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 204/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

(2)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30) and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).

(3)  Regulation (EU) 2019/1020.

(4)  Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008 (OJ L 91, 29.3.2019, p. 1).

(5)  Now superseded by Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).

(6)  Since 1.1.2013 and under Regulation (EU) No 1025/2012 each national standardisation body is obliged to make its work programme publicly available and to notify the existence thereof to the other national standardisation bodies, to the European standardisation organisation and to the Commission.

(7)  For further information see the ‘Commission Notice - Guide on Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU)’ C(2021)1457 and available here https://ec.europa.eu/docsroom/documents/44906/attachments/2/translations/en/renditions/native and https://ec.europa.eu/docsroom/documents/44906/attachments/3/translations/en/renditions/native

(8)  Judgment of the Court of Justice of 20 February 1979. - Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein. Case 120/78. European Court reports 1979 Page 649.

(9)  OJ L 218, 13.8.2008, p. 21.

(10)  For further information on the application of Regulation (EU) 2019/515: ‘Commission Notice - Guidance document for the application of Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008’ C(2021)1455 and available here: https://ec.europa.eu/docsroom/documents/44930/attachments/1/translations/en/renditions/native

(11)  OJ C 136, 4.6.1985, p. 1.

(12)  OJ L 316, 14.11.2012, p. 19.

(13)  Article 2.4 of the WTO TBT Agreement.

(14)  Initially legislation adopted under the New Approach technique was essentially in the form of Directives.

(15)  References 93/465/EEC: Council Decision of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives (OJ L 220, 30.8.1993, p. 23).

(16)  OJ L 218, 13.8.2008, p. 82.

(17)  OJ C 282, 25.11.2003, p. 3.

(18)  So called by the European Parliament in memory of Michel Ayral, the Director in Directorate General Enterprise and Industry, responsible for putting the Package together.

(19)  OJ L 218, 13.8.2008.

(20)  The word « quality » is used to designate the level of safety and other public policy objectives which are aimed by the Union harmonisation legislation. Not to be confused with the meaning of the word ‘quality’ in the commercial context allowing differentiating between different levels of product quality.

(21)  OJ L 11, 15.1.2002, p. 4.

(22)  https://ec.europa.eu/info/business-economy-euro/product-safety-and-requirements/product-safety/consumer-product-safety_en

(23)  Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).

(24)  Decision No 768/2008/EC and Regulation (EC) No 765/2008.

(25)  There are however references to GPSD in relation to specific situations such as second-hand products.

(26)  Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, p. 121).

(27)  Some Union harmonisation legislation covers also ‘putting into service’(e.g. lifts) or ‘own use’ (e.g. machinery to be used by the manufacturer himself) as being equivalent to the ‘placing on the market’.

(28)  Directive 2014/90/EU on marine equipment refers both to the placing on the market and to the placing on board of a ship flying the flag of an EU Member State, see its Article 6.

(29)  For placing on the market, making available on the market and putting into service, see Sections 2.2, 2.3 and 2.5.

(30)  Directive (EU) 2019/771 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the sale of goods, amending Regulation (EU) 2017/2394 and Directive 2009/22/EC, and repealing Directive 1999/44/EC is beyond the interest of this Guide. According to this directive, sellers of consumer products within the EU are obliged to guarantee the conformity of the products with a contract, for a period of two years after their delivery. If the products are not delivered in conformity with the sales contract, consumers can ask for the products to be repaired, replaced, and reduced in price or for the contract to be rescinded. The final seller, who is responsible to the consumer, can also hold the producer liable in their business relationship.

(31)  See chapter 3.4 Distributor.

(32)  This implies that the economic operator that offers the product has to be in a position to provide the evidence that the product complies with the applicable requirements or ensure that such information is provided i.e. by providing the technical file on request of a market surveillance authority.

(33)  See Article 6 and recital 15 of Regulation (EU) 2019/1020.

(34)  Union harmonisation legislation does not prohibit the manufacture of products to meet the requirements of a non-EU Member State, if such products will not be placed and/or put into service on the Union market. Union harmonisation legislation does not prohibit the import of products that do not meet the requirements of the relevant Union harmonisation legislation, if such products are not intended to be placed on the market or put into service on the Union market (e.g. refined/processed/incorporated in the internal market) but to be exported outside the EEA.

(35)  In this context the Union should be considered to mean the present Member States, where free movement of used and second-hand products takes place according to Articles 34 and 36 TFEU.

(36)  In some situations the responsibilities of the original manufacturer are taken over by another person, see Chapter 3.

(37)  When outside the scope of relevant Union harmonisation legislation, spare parts or parts which are available and marketed separately as products intended for consumers in order to be integrated to other products, such as service parts or components intended for maintenance or repair, must nevertheless comply with the general safety requirement set out in the GPSD.

(38)  Under medical devices legislation, the term ‘fully refurbished’ is defined (Article 2(31)). ‘Fully refurbished’ products are assimilated to new products.

(39)  A number of Commission Regulations adopted on 1 October 2019 pursuant to Directive 2009/125/EC require the availability of spare parts during a specified period of time for certain product categories (such as household dishwashers, refrigerating appliances, household washing machines and household washer-dryers, electronic displays).

(40)  For products used at the workplace the employer must take all measures necessary to ensure that work equipment is suitable and safe and that repaired machinery is no less safe than the original. See Section 3.5.

(41)  See Article 2 (1) and recital 19 of Regulation (EU) 2017/745 on medical devices and Article 2 (1) and recital 17 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

(42)  For example, the Machinery Directive 2006/42/EC (Section 1.2.1 of Annex I) requires that a fault in the software of the control system does not lead to hazardous situations. The Measuring Instruments Directive 2014/32/EU requires that software that is critical for metrological characteristic shall be identified as such and secured, and that software that is critical for measurement characteristics shall be protected against corruption (Section 8 of Annex I). Software aspects are also taken into account in Directive 2014/53 (Radio Equipment Directive).

(43)  See Article 2 of Regulation (EC) No 765/2008, Article 3 of Regulation (EU) 2019/1020 and Article R1 of Annex I of Decision No 768/2008/EC.

(44)  Excluding intellectual property rights.

(45)  In case of the making available of a product taking place through renting, repeated renting of the same product does not constitute a new placing on the market. That product would need to be in compliance with the applicable Union harmonisation legislation at the time the first renting takes place.

(46)  E.g. the Lifts Directive uses the concept of ‘installer’ who also places on the market.

(47)  The distribution chain can also be the commercial chain of the manufacturer or the authorised representative.

(48)  See for instance, the Directives on Machinery, Measuring Instruments, ATEX, Civil Explosives.

(49)  When Union harmonisation legislation covers own use, this does not refer to the occasional manufacturing for own use by a private person in a non-commercial context.

(50)  This exception does not include products which are shipped by the economic operator to the consumers in the EU, such as the case of products bought online and shipped to the EU.

(51)  For authorised representative, see Section 3.2.

(52)  See Regulation (EU) No 952/2013 establishing the Union customs code. In accordance with this Regulation, non-Union goods placed under a suspensive customs procedure or in a free zone are subject to customs supervision and do not benefit from the free circulation in the internal market. Before benefiting from the free circulation in the internal market, these goods must be declared for release for free circulation. That entails application of commercial policy measures, completion of the other formalities laid down in respect of the importation of goods and the charging of any duties legally due.

(53)  The prototype must be safe and under complete control and supervision. Controlled conditions would mean expert operators, restrictions to public contact with the product, avoiding inappropriate interaction with other neighbouring products etc.

(54)  However, in such circumstances a visible sign must clearly indicate that the product in question may not be placed on the market or put into service until it has been made to comply.

(55)  The design in accordance with the essential requirements of the applicable legal act, the following risk and conformity assessment, the issue of a Declaration of Conformity, the marking requirements (CE marking, name, address of the manufacturer etc.), the compilation of the technical file, must have been completed by the manufacturer at the time of placing on the market.

(56)  Except if they had been placed on the Union market prior to their export to a third country, and subsequent import into the Union.

(57)  For market surveillance, see Chapter 7.

(58)  See Article 6 of Regulation (EU) 2019/1020.

(59)  See recital 15 and Article 6 of Regulation (EU) 2019/1020.

(60)  See inter alia Article 7(1) of Regulation (EU) 2019/1020.

(61)  This explanation does not attempt to deal with the question of intermediary liability and the term ‘online operator’ used in this context may not cover such intermediaries.

(62)  For putting into service, see Section 2.6.

(63)  See recital 53 of Regulation (EU) 2019/1020.

(64)  See Articles 25 to 28 of Regulation (EU) 2019/1020.

(65)  For the role of the importer, see Point 3.3.

(66)  Please note that in the area of medical devices, the role of the authorised representative is reinforced and he is the primary interlocutor of market surveillance authorities for products for third countries.

(67)  For the role of the economic operator referred to in Article 4 of Regulation (EU) 2019/1020, see point 3.6.

(68)  The concept of ‘putting into service’ is not relevant for all Union harmonisation legislation. It also may differ according to specific Union harmonisation legislation, such as the legislation on medical devices.

(69)  As regards lifts and equivalent products, the putting into service should be considered to take place at the moment when the first use within the Union is possible.

(70)  In the case of the Radio Equipment Directive 2014/53/EU, Article 7 regulates restrictions to the putting into service. Member States may restrict the putting into service of radio equipment for reasons related to the effective and appropriate use of the radio spectrum, avoidance of harmful interference or matters related to public health.

(71)  E.g. energy consumption.

(72)  For instance: the Directive relating to low voltage equipment is not applicable to electrical equipment for medical purposes, instead the legislation relating to medical devices will apply; the Directive relating to electromagnetic compatibility is not applicable to products covered by specific legislation that harmonises the protection requirements specified in the Directive on electromagnetic compatibility; the Directive relating to lifts is not applicable to lifts connected to machinery and intended exclusively for access to the workplace, instead the Directive relating to machinery applies; marine equipment, which is also within the scope of other directives than the Directive on marine equipment, is excluded from the application of such directives. Radio equipment falling within the scope of the Radio Equipment Directive 2014/53/EU is exempted from the application of the Low Voltage Directive 2014/35/EU.

(73)  E.g. Lifts Directive 2014/33/EU includes relevant requirements of the Machinery Directive 2006/42/EC and Radio Equipment Directive 2014/53/EU includes the essential requirements of Low Voltage Directive 2014/35/EU and Electromagnetic Compatibility Directive 2014/30/EU.

(74)  For example: the Machinery Directive covers all hazards that come from machinery, including electrical hazards. However, concerning the electrical hazards of machinery, the Machinery Directive is referring to the safety objectives of the Low Voltage Directive, to be applied solely.

(75)  For making available, see Section 2.2.; for putting into service, see 2.6.

(76)  Please note that the Machinery Directive 2006/42/EC requires the manufacturer to take account of ‘reasonably foreseeable misuse’.

(77)  For outdoor products, also considering the effects of the changing climate.

(78)  Furthermore, a tool designed and intended to be used by professionals only, might eventually also be used by non-professionals; consequently the design and instructions accompanied must take this possibility into account.

(79)  For climate-proofing products, manufacturers and standard-writers may seek guidance from ISO:EN 14091, CEN Guide 32 and the Commission notice 2021/C 373/01 on technical guidance on the climate proofing of infrastructure in the period 2021-2027. Although these documents relate to making infrastructure and organisations climate resilient, the principles of vulnerability and risk assessment and some methods for increasing resilience can be applied to products too.

(80)  For more details, please consult Commission Staff Working Paper on Obstacles to access by Andorra, Monaco and San Marino to the EU’s Internal Market and Cooperation in other Areas (SWD(2012) 388 final) available at:https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A52012SC0388

(81)  For more information on the consequences of the withdrawal of the UK from the EU see https://ec.europa.eu/info/sites/info/files/notice_to_stakeholders_industrial_products.pdf

(82)  Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (OJ L 29, 31.1.2020, p. 7) (‘Withdrawal Agreement’).

(83)  https://ec.europa.eu/info/sites/default/files/notice_to_stakeholders_industrial_products.pdf

(84)  See Section 3.3 below on the importer. In the case of lifts, there are no importers or distributors as lifts only come into existence as finished products once they have been installed in buildings or constructions. Consequently, lifts are only placed on the market by the installer when, after installation and completion of the applicable conformity assessment procedure, affixing of the CE marking and issuance of the Declaration of Conformity, they are supplied for use. See Article 2(5) and recital 4 of Directive 2014/33/EU.

(85)  Article 11 of Regulation (EU) 2017/745 (replacing as of 26 May 2021 Directives 90/385/EEC and 93/42/EEC, where the corresponding provisions were Article 10a and Article 14 respectively) and Article 10 of Directive 98/79/EC on in vitro diagnostic medical devices (to be replaced as of 26 May 2022 by Regulation (EU) 2017/746 where the corresponding provision is Article 11).

(86)  Article 13 of Directive 2014/90/EU.

(87)  The legal consequences set out also apply, mutatis mutandis, in relation to certificates or approvals issued by a user inspectorate or a recognised third-party organisation designated by the UK authorities under the Pressure Equipment Directive 2014/68/EU.

(88)  In the field of recreational craft and personal watercraft, each watercraft placed on the EU market must also bear a unique code of the manufacturer assigned by Member State authorities or authorised national bodies.

(89)  See chapter 6 of this guide for further details on accreditation.

(90)  Article 185 of the Withdrawal Agreement.

(91)  Article 18 of the IE/NI Protocol.

(92)  Article 5(4) and Sections 8 to 19, 21, 23, 27, and 28 of annex 2 to the IE/NI Protocol.

(93)  Article 7(1) of the Withdrawal Agreement in combination with Article 13(1) of the IE/NI Protocol.

(94)  Where an information exchange or mutual consultation is necessary, this will take place in the joint consultative working group established by Article 15 of the IE/NI Protocol.

(95)  Fifth subparagraph of Article 7(3) of the IE/NI Protocol.

(96)  Article 13(6) of the IE/NI Protocol.

(97)  First subparagraph of Article 7(3) of the IE/NI Protocol.

(98)  Fourth subparagraph of Article 7(3) of the IE/NI Protocol.

(99)  Fourth subparagraph of Article 7(3) of the IE/NI Protocol.

(100)  For instance, such product can still be sold legally after the transitional period if the product is on stock at the distributors’ warehouse, i.e. that the product has been already placed on the market and that a change of ownership has taken place.

(101)  Since the Directive on pressure equipment sets no time limit for the putting into service, products covered by this Directive can be put into service at any time without being subject to further conditions according to this Directive. For placing on the market and putting into service, see Sections 2.3 and 2.5.

(102)  For the EU declaration of conformity, see Section 4.4.; for the CE marking, see Section 4.5.1.

(103)  In February 2014, an ‘Alignment Package’ consisting of eight directives was adopted. The Directives of the alignment package will become applicable on 20 April 2016 and their essential requirements are not modified. It includes Directive 2014/35/EU (Low Voltage); Directive 2014/30/EU (Electromagnetic Compatibility); Directive 2014/34/EU (ATEX); Directive 2014/33/EU (Lifts); Directive 2014/29/EU (Simple Pressure Vessels); Directive 2014/32/EU (Measuring Instruments); Directive 2014/31/EU (Non-automatic Weighing Instruments); Directive 2014/28/EU (Civil Explosives). Directive 2013/29/EU (Pyrotechnic Articles) has also been aligned to Decision No 768/2008/EC and became applicable on 1 July 2015.

(104)  See Article R1 (7) of Annex I of Decision No 768/2008/EC and Article 3 of Regulation (EU) 2019/1020. Some legislation includes other specific entities that have obligations to fulfil, such as Directive 2013/53/EU on recreational craft and personal watercraft, which requires that a private importer, before putting the product into service, shall ensure that it has been designed and manufactured in accordance with the requirements set out in the relevant legislation. Market surveillance authorities should address such entities if they are the most relevant ones for a case. The definition of economic operator in Regulation (EU) 2019/1020 extends to such entities by referring to ‘any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation’ and gives non-exhaustive list of examples in recital 14. Further examples are the owner and the operator defined in Directive 2010/35/EU, and the dealer and a natural or legal person who engages in the storage, use, transfer, import, export or trade of explosive, referred to in Directive 2014/28/EU.

(105)  See Article R1 (3) of Annex I of Decision No 768/2008/EC.

(106)  See Article R6 of Annex I of Decision No 768/2008/EC.

(107)  Those manufacturers are often referred to as ‘own brand labellers’ or ‘private labellers’.

(108)  Lifts Directive 2014/33/EU uses the concept of installer to impose responsibilities on the person who makes a product operational and ready to use. The role of the installer combines elements of manufacture and putting into service and is seen as fundamental for delivering the final product.

(109)  Article R2 (1) of Decision No 768/2008/EC.

(110)  The use of symbols according to international standards may be an alternative to written statements.

(111)  In some specific cases, where several identical products are bundled and intended by the manufacturer to be sold together to the end-user or to be sold in a packaging for use in one application (e.g. installation equipment), it is sufficient to accompany the shipping unit with one set of instructions. However, if the bundle is dismantled and the different identical products sold individually, the economic operator dismantling the bundle and making available the individual products needs to make sure that a set of instructions and safety information accompanies each individual product.

(112)  Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.

(113)  The manufacturer, importer and distributor have the obligation to ensure that the product is accompanied by instructions in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. It is for each economic operator which makes available the product in a Member State, to ensure that all the required languages are available.

(114)  Unless otherwise specified in specific legislation, whilst the safety information needs to be provided on paper, it is not required that all the set of instructions is also provided on paper but they can also be on electronic or other data storage format or even a website. Where this is the case, the full set of instructions must remain accessible for a reasonable period after the product was placed on the market depending on the intended use of the product. However, a paper version should always be available free of charge for the consumers who request it. The manufacturer must take account of the intended use and end users of the product when deciding the specific format for the instructions and safety information.

(115)  To be understood as the last item of the product model placed on the market.

(116)  For the legislation on Medical Devices, the manufacturer must indicate the place of business.

(117)  This does not include esthetical reasons.

(118)  Please note that some Union harmonisation legislation excludes the possibility to use the packaging to satisfy this requirement (e.g. Simple Pressure Vessels Directive).

(119)  Manufacturers may add a website to the contact information, an email address or a phone number. A website address may be given in addition to, but not instead of a postal address. Normally an address consists of a street and number or post-box and number and the postal code and town, but some countries might deviate from this model. Also, it is useful to include an email address and/or phone number to facilitate swift contacts with the relevant authorities.

(120)  See Union harmonisation legislation relating to low voltage equipment, toys, machinery, non- automatic weighing instruments, active implantable medical devices, gas appliances, medical devices, potentially explosive atmospheres, recreational craft, lifts, pressure equipment, in vitro diagnostic medical devices, and radio and telecommunications terminal equipment. Further, according to the legislation on in vitro diagnostic medical devices, a manufacturer who places devices on the Union market under his own name is obliged to register in the Member State where he has his place of business.

(121)  For more information on the name and address requirement, see Point 4.2.2.1.

(122)  E.g. ATEX marking, the noise marking for outdoor equipment or the supplementary metrology marking in the case of non-automatic weighing machines and measuring instruments.

(123)  For the information obligations in the case of EU-type examination certificates, see Annex II of Decision No 768/2008/EC, Module B, point 7.

(124)  E.g. the Directives on Simple pressure vessels and ATEX.

(125)  Such sample testing should be performed when deemed appropriate with regard to the risks presented by a product, in view of protecting the health and safety of consumers (see Article R2.4 of Decision No 768/2008/EC).

(126)  The acceptable level of risk for the product is defined by the essential requirements set out in the applicable Union harmonisation legislation. Consequently, manufacturers must inform the competent authority where they consider or have reason to believe that the product does not comply with the applicable essential requirements.

(127)  https://webgate.ec.europa.eu/gpsd/screen/public/home

(128)  The reasoned request does not necessarily mean a formal decision by an authority. According to Article 7 (1) of Regulation (EU) 2019/1020, ‘economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators’. For a request to be reasoned it is sufficient the market surveillance authority explains the context in which the information is requested (e.g. inspection on specific characteristics of the products, random checks, etc.).

(129)  This is not applicable to products covered by the Union harmonisation legislation relating to toys, low voltage equipment, civil explosives and refrigeration appliances, since these directives only cover making available on the market. Further, this is not applicable to recreational craft built for own use, provided that it is not subsequently placed on the market during a period of five years, or to craft designed before 1950.

(130)  Article R6 of Annex I of Decision No 768/2008/EC.

(131)  Further, according to the Directives relating to machinery and lifts, obligations regarding the conformity assessment procedure fall to any person placing the product on the market, where neither the manufacturer nor the authorised representative or the installer of the lift fulfils these obligations.

(132)  Please note that not all Union harmonisation legislation provides for an authorised representative.

(133)  As an exception, according to the legislation on medical devices and in vitro diagnostic medical devices the manufacturer must designate a person who is established in the Union to be responsible for the marketing of medical devices, if he does not have a registered place of business in a Member State and he places devices on the Union market under his own name. The Directive on Marine Equipment 2014/90/EU also requires the manufacturer who is not located in the territory of at least one Member State to appoint an authorised representative for the Union. A manufacturer established outside the EU may, for certain supply chains, also need an authorised representative to act as the economic operator referred to in Article 4 of Regulation (EU) 2019/1020.

(134)  For the obligations of the importer see Section 3.3.

(135)  For the purposes of this Guide, imports are products manufactured in third countries and placed on the Union market. Products manufactured in one Member State and placed on the market in another Member State do not constitute an ‘import’ as the operation takes place within the Union internal market.

(136)  The importer is not necessarily the person who transports the product, but can be the person on behalf of whom this logistic activity is performed.

(137)  See Chapter 7 on Market Surveillance.

(138)  Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.

(139)  In light of these obligations, it is generally considered good practice for importers to: refer to the applicable EU legislation in the contract with his supplier (mentioning the obligations of manufacturers under Union law); ensure that he has access to the technical file, or ensure that the manufacturer has signed an obligation to provide the technical documentation if requested by market surveillance authorities.

(140)  Depends on the applicable Union harmonisation legislation.

(141)  Please note that some sectoral Union harmonisation legislation might provide for stricter requirements.

(142)  To be understood as the last item of the product model placed on the market.

(143)  Importers are not obliged to have a copy of the technical documentation but they shall ensure that it is made available to the relevant authorities upon request. Even if there is no explicit obligation, the importer is advised to require formal assurance in writing from the manufacturer that the documents will be made available when requested by the surveillance authority.

(144)  The reasoned request does not necessarily mean a formal decision by an authority. According to Article 7 (1), of Regulation (EU) 2019/1020, ‘economic operators shall cooperate with market surveillance authorities regarding actions which could eliminate or mitigate risks that are presented by products made available on the market by those operators’. For a request to be reasoned it is sufficient the market surveillance authority explains the context in which the information is requested (e.g. inspection on specific characteristics of the products, random checks, etc.).

(145)  Article R4(6) of Annex I of Decision No 768/2008/EC.

(146)  Due care refers to the effort made by an ordinarily prudent or reasonable party to avoid harm to another, taking the circumstances into account. It refers to the level of judgment, care, prudence, determination, and activity that a person would reasonably be expected to do under particular circumstances.

(147)  Article R5(1) of Annex I of Decision No 768/2008/EC.

(148)  Article R5(2), 1st paragraph of Annex I of Decision No 768/2008/EC.

(149)  Where the Union harmonisation legislation explicitly requires that the product is accompanied by the EU declaration of conformity, the distributor has to ensure that this is the case.

(150)  Not all Union harmonisation legislation requires both instructions and safety information since not all Union harmonisation legislation is safety related.

(151)  See the obligations of the manufacturer in point 3.1 and the obligations of the importer in point 3.3.

(152)  Article R5(2), 2nd paragraph, of Annex I of Decision No 768/2008/EC.

(153)  Article R5(2), 2nd paragraph and Article R5(4) of Annex I of Decision No 768/2008/EC.

(154)  The reasoned request does not necessarily mean a formal decision by an authority. According to Article 19 (1), paragraph 2 of Regulation (EU) No 765/2008, ‘market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities’. For a request to be reasoned it is sufficient the market surveillance authority explains the context in which the information is requested (e.g. inspection on specific characteristics of the products, random checks, etc.).

(155)  Article R5(5) of Annex I of Decision No 768/2008/EC.

(156)  Article R7(2) of Annex I of Decision No 768/2008/EC.

(157)  Article R5(3) of Annex I of Decision No 768/2008/EC.

(158)  See Judgement of the Court: case C-271/92.

(159)  As defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14).

(160)  As defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19).

(161)  See Article 3(11) of Regulation (EU) 2019/1020.

(162)  As they included in the definition of economic operators in Article 3 of Regulation (EU) 2019/1020, which is referred to, inter alia, in Articles 7 and 14 of the Regulation.

(163)  For more information on the responsible economic operator, please consult the Commission Notice C(2021)1461 ‘Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products’ https://ec.europa.eu/docsroom/documents/44908/attachments/2/translations/en/renditions/native

(164)  This Union harmonisation legislation covers safety of toys, electrical equipment, radio equipment, electromagnetic compatibility, restriction of hazardous substances in electrical and electronic equipment (‘RoHS’), energy-related products (‘ecodesign’), gas appliances, construction products, machinery, outdoor equipment (‘outdoor noise’), equipment for use in potentially explosive atmospheres (‘ATEX’), pressure equipment, simple pressure vessels, pyrotechnic articles, recreational craft, measuring instruments, non-automatic weighing instruments, personal protective equipment and unmanned aircraft systems (‘drones’).

(165)  Paragraph 4 of Article 4 of Regulation (EU) 2019/1020.

(166)  See Sections 3.1 and 3.3 above.

(167)  Recital 53 of the Regulation reminds that Articles 220, 254, 256, 257 and 258 of Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1) provide that products entering the EU market that require further processing in order to be in compliance with the applicable EU harmonisation legislation shall be placed under the appropriate customs procedure allowing such processing by the importer.

(168)  To be understood as the last item of the product model placed on the market.

(169)  These options are specifically referred to in most Union harmonisation legislation for the manufacturer and importer; further potential corrective actions are listed in Article 16 of Regulation (EU) 2019/1020.

(170)  Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1).

(171)  Other activities also described by the Directive are: 1) ‘mere conduit activities’ such as transmitting information (provided by the recipient of the service) or providing access to a communication network (e.g. internet providers) and 2) ‘caching activities’ such as making the transmission of information more efficient, e.g. duplicating a database which copies the content of the initial server for ensuring a global coverage.

(172)  In Case C-324/09, L’Oréal vs. eBay, the European Court of Justice clarified that the relevant question relating to the conditions for benefiting from a liability exemption was whether eBay was aware of facts and circumstances from which the illegal activity was apparent (see paragraphs 120-123).

(173)  Commission Notice on the market surveillance of products sold online (OJ C 250, 1.8.2017, p. 1).

(174)  See Article 3 of Regulation (EU) 2019/1020.

(175)  However, Directive 2013/53/EU on Recreational craft imposes obligations on private importers.

(176)  For more details please see Sections 4.2 and 3.6.

(177)  For the concept of ‘intended use’, see above Section 2.8.

(178)  For the technical documentation, see Point 4.3.

(179)  Even where the manufacturer uses a harmonised standard (where its reference is published in the OJEU and which aims to cover certain risks) to satisfy essential requirements, the risk assessment has to be carried out and he must check whether the harmonised standard covers all risks of the product. This is because it cannot be assumed that the harmonised standard covers all requirements of all legislative acts applicable to a given product (or, indeed, all the requirements of the specific act under which it has been developed) or whether the product in question introduces also other risks not considered in the harmonised standard.

(180)  According to the Directive (EU) 2016/797 on the interoperability of the rail system within the European Union each sub-system is covered by a Technical Specification of Inter-operability (TSI), which specifies the essential requirements. According to Regulation (EC) No 552/2004 on the interoperability of the European Air Traffic Management network, in case of necessity, the essential requirements are refined or complemented by implementing rules for interoperability.

(181)  Such as the general safety and performance requirements under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices.

(182)  OJ L 316, 14.11.2012, p. 12.

(183)  For the definition of a ‘technical specification’, see Article 2(4) of Regulation (EU) No 1025/2012.

(184)  CEN (European Committee for Standardisation); CENELEC (European Committee for Electrotechnical Standardisation); ETSI (European Telecommunication Standards Institute).

(185)  (SWD(2015) 205 final, 27.10.2015) available at https://ec.europa.eu/growth/single-market/european-standards/vademecum-european-standardisation_en

(186)  In reality the ESOs may only declare an intention to cover certain requirements and this intention is further presumed (or removed) once a reference is published (or removed) in (from) the OJEU (see Points 4.1.2.4 and 4.1.2.5).

(187)  The ESOs usually name this annex as ‘Annex ZA, ZB or ZZ’ etc.

(188)  It is essential to understand that making a reference to a harmonised standard in an EU declaration of conformity without applying that standard, or parts thereof, does not initiate ‘presumption of conformity’.

(189)  In this context this term is understood as defined in ISO/IEC Guide 51 Safety aspects - Guidelines for their inclusion in standards, which is a generic guideline to develop standards addressing safety issues.

(190)  A Web service providing access to the latest lists of references of harmonised standards and of other European standards published in the Official Journal of the European Union (OJEU) is available at: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en

(191)  Voluntary nature of standards makes reference to the fact that standards as such and as published by standardisation organisations are always of voluntary application.

(192)  See the Directives relating to simple pressure vessels, toys, electromagnetic compatibility, radio equipment, machinery, lifts and recreational craft. The lack of harmonised standards may lead to the application of a specific procedure, see for instance the Pressure Equipment Directive (the European approval may be granted to materials which are not covered by any harmonised standard and which are intended for repeated use in the manufacture of pressure equipment) or the Regulations on medical devices and on in vitro diagnostic medical devices (providing for a possibility for the Commission to adopt ‘common specifications’ by means of implementing acts).

(193)  Article 11 of Regulation (EU) No 1025/2012 becomes gradually applicable after objection articles contained in sectoral legislation are removed. Meanwhile some Union harmonisation legislation may still contain specific procedures, like the Directive relating to radio equipment that provides for a possibility for the Commission, in the case of shortcomings of harmonised standards, to publish in the Official Journal guidelines to the interpretation of harmonised standards, or the conditions under which compliance is possible.

(194)  The European Parliament can raise this concern in cases where Article 11 of Regulation (EU) No 1025/2012 applies.

(195)  In accordance with Article 11(1) and 11(4)-(5) of Regulation (EU) No 1025/2012.

(196)  For the safeguard clause, see Section 7.4.

(197)  https://ec.europa.eu/growth/single-market/european-standards/notification-system_en

(198)  Under the terms of their internal rules, the ESOs review their standards – whether or not initially developed on the basis of a standardisation request– at intervals not exceeding five years. This periodical review may lead to a confirmation (no action), a revision or a withdrawal of a relevant standard.

(199)  Vademecum on European standardisation (SWD(2015) 205 final, 27.10.2015, Part III).

(200)  See also the definition of ‘European standardisation deliverables’ in Article 2(2) of Regulation (EU) No 1025/2012.

(201)  In the case of Regulation (EC) No 552/2004 on the interoperability of the European Air Traffic Management network, if a manufacturer chooses not to follow a harmonised standard, the declaration is called declaration of suitability for use.

(202)  Directive (EU) 2016/2102 on the Accessibility of the websites and mobile applications of public sector bodies, Regulation (EU) 2017/745 on Medical Devices, Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices, Regulation (EU) 2019/1009 on Fertilizers and Directive (EU) 2019/882 on the Accessibility requirements for products and services.

(203)  E.g. common specifications under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices.

(204)  E.g. technical specifications for accessibility requirements under Directive (EU) 2016/2102 on the Accessibility of the websites and mobile applications of public sector bodies, technical specifications for accessibility requirements under Directive (EU) 2019/882 on the Accessibility requirements for products and services or common specifications under Regulation (EU) 2019/1009 on Fertilizers.

(205)  Such confusion might occur for instance when the name of the distributor appears on the packaging while the manufacturer’s name is shown on the product inside.

(206)  A trade mark is a distinctive sign or indicator used by an individual, business organisation, or other legal entity to identify that the products or services to consumers with which the trade mark appears originate from a unique source, and to distinguish the products or services in question from those of other entities. A trademark is a type of intellectual property, and typically a name, word, phrase, logo, symbol, design, image, or a combination of these elements.

(207)  Article R2(6) of Annex I of Decision No 768/2008/EC.

(208)  Article R4(3) of Annex I of Decision No 768/2008/EC.

(209)  Paragraph 4 of Article 4 of Regulation (EU) 2019/1020.

(210)  Article R2(5) of Annex I of Decision No 768/2008/EC.

(211)  Article R7 of Annex I of Decision No 768/2008/EC.

(212)  See Recital 25 of Decision No 768/2008/EC.

(213)  For instance, an address serving as an information point for consumers and other users in the Member State where the product is made available.

(214)  In the medical devices sector, the product must also bear the authorised representative’s name and address.

(215)  If the importer is only affixing his name and address and leaves the trademark of the original manufacturer, he remains importer. The address of importer and manufacturer will appear on the product (or packaging or accompanying documents).

(216)  This is also the case if the manufacturer and importer belong to the same group of companies, and the company based in the EU importing the product into the EU assumes the full manufacturer’s responsibility for the product.

(217)  In the case of toys, this might be the case for toys consisting of several parts or an assembly of several parts.

(218)  For placing on the market, see Section 2.3.

(219)  In the field of medical devices, the manufacturer shall for implantable devices keep, the EU declaration of conformity available for the competent authorities for at least 15 years after the last device has been placed on the market (Article 10(8) of Regulation 2017/745).

(220)  See the Directives relating to simple pressure vessels, machinery (for module B), non-automatic weighing instruments, gas appliances, medical devices, potentially explosive atmospheres, lifts (for modules B, C, D, G, H), pressure equipment, in vitro diagnostic medical devices, and radio equipment.

(221)  Please note that the Machinery Directive 2006/42/EC foresees the placing on the market of ‘partly completed machinery’ to be accompanied by a so- called declaration of incorporation which is different from the EU Declaration of conformity. According to Regulation (EC) No 552/2004, constituents of the European Air Traffic Management network are accompanied either by a declaration of conformity or a declaration of suitability for use.

(222)  For more information on the technical documentation, see Section 4.3.

(223)  According to the legislation on medical devices the EU Declaration of Conformity must be kept in the case of implantable medical devices for 15 years.

(224)  For responsibilities of the manufacturer, the authorised representative and the importer, see Chapter 3.

(225)  See Article R10.2 of Decision 768/2008/EC.

(226)  The ‘number’ can be an alpha-numerical code too.

(227)  In addition, whether this is expressly envisaged or not by the Union harmonisation legislation manufacturers are free to add a number identifying the EU Declaration of Conformity itself in line with EN ISO/IEC 17050-2.

(228)  Not all Union harmonisation legislation requires the intervention of a notified body, or not for all products.

(229)  The name and address of the person who keeps the technical documentation may also be required by some pieces of Union harmonisation legislation since according to those, not only the manufacturer shall keep the technical documentation.

(230)  This could be the Managing Director of the company or another representative of the company to whom this responsibility has been delegated.

(231)  It is not necessary for the signatory to be domiciled in the European Union. A manufacturer established outside the Union is entitled to carry out all the conformity assessment procedures at his premises and, to sign the EU Declaration of Conformity, unless otherwise provided for in the relevant Union harmonisation legislation.

(232)  Article 5 from Decision No 768/2008/EC.

(233)  See for example recital 22 of Directive 2014/35/EU, or the similar recital 24 of Directive 2014/34/EU.

(234)  Article R10(2) of Annex I of Decision No 768/2008/EC.

(235)  Conformity assessment according to the construction products legislation does not follow Decision No 768/2008/EC although construction products legislation provides for the CE marking. The difference is that the CE marking under construction products legislation indicates the level of performance of the product and not conformity in the stricter sense as it is the case for the other legislative acts providing for the CE marking.

(236)  Such as machinery, personal protective equipment, active implantable medical devices, medical devices, potentially explosives atmospheres, lifts – as regards small-scale machinery, in vitro diagnostic medical devices, radio equipment or marine equipment.

(237)  For example, the use of an LCD display to affix the CE marking has been considered as appropriate for certain products, such as lifts, provided that the manufacturer ensures that legibility, visibility and indelibility are respected and, in particular, the word of ‘indelibly’ suggests that it must be a permanent indication that cannot disappear due to an electronic failure or effaced over the lifetime or the use of the lift car.

(238)  Please note that in the case where several Union harmonisation acts apply to a product and the CE marking appears with an identification number, this does not mean that the notified body intervenes in the conformity assessment process required by each of the applicable acts. Some of the applicable Union harmonisation legislation might not require the intervention of a notified body.

(239)  Regulation (EC) No 552/2004 on the interoperability of the European Air Traffic Management network does not provide for CE marking.

(240)  The typical example can be a computer.

(241)  See under Points 4.5.1.7 and 4.5.2.

(242)  Under the Ecodesign directive the conformity assessment procedures (to be specified in the implementing measure) is laid down in the directive itself as a rule, but in duly justified cases the modules of Decision No 768/2008 are prescribed.

(243)  The relevant modules are modules C, C1, C2, D, E and F.

(244)  Quality management systems —- Fundamentals and vocabulary.

(245)  Quality management systems —- Requirements.

(*1)  The legislator may restrict manufacturer’s choice.

(246)  For subcontracting by notified bodies, see Section 5.2.5.

(247)  See Annex II of Decision No 768/2008/EC, Module B, point 8, 3rd paragraph.

(248)  For more information on the notified body number in NANDO, see Point 5.3.3.

(249)  Article R27(4) of Annex I of Decision No 768/2008/EC.

(250)  For Mutual Recognition Agreements, see Section 9.2.

(251)  For market surveillance, see Chapter 7.

(252)  Having said that it is common practice in some sectors (e.g. explosives and pyrotechnics articles) that market surveillance authorities rely on notified bodies’ testing provided that there is no conflict of interests.

(253)  For the coordination between notified bodies, see Point 5.2.4.

(254)  Article R17(11) of Annex I of Decision No 768/2008/EC.

(255)  Article R30(1) of Annex I of Decision No 768/2008/EC.

(256)  For the role and responsibilities of notified bodies see Point 5.2.2.

(257)  Article R20(4) of Annex I of Decision No 768/2008/EC.

(258)  Please note that only a limited number of Union harmonisation legislation provides for accredited in-house bodies.

(259)  Union harmonisation legislation aligned to Decision No 768/2008/EC includes modified provisions on notified bodies. In view of notifying bodies for the purposes of such legislation, it is essential that at least the relevant provisions concerning notified bodies (which include in particular the requirements and obligations of those bodies) are transposed into national law. In addition, notification procedures need to be communicated to the Commission and other Member States, and Member States need to appoint the notifying authority for that particular Union harmonisation legislation.

(260)  Article R20(1) of Annex I of Decision No 768/2008/EC sets out the obligations of the notified body when it subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary.

(261)  EA-2/17 - EA Document on Accreditation for Notification Purposes.

(262)  Article 7 of the Regulation identifies this as a situation where a conformity assessment body may seek accreditation outside its Member State of establishment.

(263)  A similar provision has been included in most Directives aligned to Decision No 768/2008/EC.

(264)  On EA’s role, see 6.5.2 and 6.5.4.

(265)  For more information on withdrawal and de-notification, see Point 5.3.4.

(266)  According to Article R26 of Decision 768/2008/EC.

(267)  The set of conformity assessment procedures to be used by Union harmonisation legislation was first set out in Council Decision 93/465/EEC (the so-called ‘modules Decision’).

(268)  NANDO website: http://ec.europa.eu/growth/tools-databases/nando/ as well as EA website: http://www.european-accreditation.org/

(269)  Article R14(2) of Annex I of Decision No 768/2008/EC.

(270)  Most of Union harmonisation legislation aligned with Decision (EC) No 768/2008, contains a provision specifying that the notifying authority may delegate the notification tasks under certain conditions. In that case, it may entrust the notification of accredited conformity assessment bodies to a national accreditation body while the notifying authority should notify the non-accredited conformity assessment bodies (should it choose to maintain unaccredited notifications). Such a system would require good internal coordination within the Member State.

(271)  See point 6.6 on cross-border accreditation.

(272)  Article 11(2) of Regulation (EC) No 765/2008.

(273)  ISO/IEC 17011.

(274)  Article R20(1) of Annex I of Decision No 768/2008/EC sets out the obligations of the notified body when it subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary.

(275)  For latest information refer to www.ilac.org and www.iaf.nu where listings of current regional members of ILAC and IAF are available.

(276)  The General Product Safety Directive also contains requirements on market surveillance.

(277)  Subject to specific Union harmonisation legislation.

(278)  Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1).

(279)  Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L 170, 25.6.2019, p. 1).

(280)  Regulation (EU) 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (OJ L 177, 5.6.2020, p. 1).

(281)  Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).

(282)  Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, p. 1).

(283)  An example on the organisation of market surveillance is the requirement in Regulations 1223/2009, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices for Member States to review and assess the functioning of their market surveillance activities. An example on market surveillance activities is the safeguard procedures based on Chapter R5 of Annex I of Decision No 768/2008/EC that is included in a large number of Union harmonisation legislation.

(284)  See chapter III of Regulation (EU) 2017/745 on medical devices.

(285)  See recital 4 of Regulation 2019/1020.

(286)  Commission Notice C(2021)1461 ‘Guidelines for economic operators and market surveillance authorities on the practical implementation of Article 4 of Regulation (EU) 2019/1020 on market surveillance and compliance of products’ https://ec.europa.eu/docsroom/documents/44908/attachments/2/translations/en/renditions/native

(287)  A list of market surveillance authorities appointed by the Member States can be found at: https://ec.europa.eu/growth/single-market/goods/building-blocks/market-surveillance/organisation_en

(288)  Further guidance is included in the Commission Notice on the market surveillance of products sold online (OJ C 250, 1.8.2017, p. 1).

(289)  See Directive 2001/95 on general product safety and, recitals 24 and 35 and Article 16; see also Regulation (EC) 765/2008, Article 19(5).

(290)  Article 30 of Regulation (EC) No 765/2008 and Directive 2001/95 on general product safety also contain provisions on penalties.

(291)  This is important for products (for example machinery and pressure equipment) that are directly, after being manufactured, installed and put into service at the premises of the client.

(292)  Article R31 of Annex I to Decision No 768/2008/EC.

(293)  Under Decision No 768/2008/EC, module B, Notified Bodies are required to provide, upon request from Member States, European Commission or other Notified Bodies a copy of the technical documentation.

(294)  Unless the EU Declaration of Conformity is required to accompany the product, in which case the distributor should provide the market surveillance authorities with such document. In the field of medical devices, the competent authorities may require distributors to, make available the documentation and information necessary for the purpose of carrying out the authorities’ market surveillance activities (Article 93(2) of Regulation 2017/745).

(295)  According to Article 14(4)(a) of Regulation (EU) 2019/1020 market surveillance authorities must have the power to ‘require economic operators to provide relevant documents, technical specifications, data or information on compliance and technical aspects of the product, including access to embedded software in so far as such access is necessary for the purpose of assessing the product’s compliance with applicable Union harmonisation legislation, in any form or format and irrespective of the medium of storage or the place where such documents, technical specifications, data or information are stored, and to take or obtain copies thereof’.

(296)  For example storing the technical documentation may be delegated to the authorised representative.

(297)  The risk must be due to the product itself when used in accordance with its intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, and thus not due to due any misuse.

(298)  For medical devices and in vitro diagnostic medical devices, Regulation 2017/745 and Regulation 2017/746 outline the procedure for dealing with devices presenting an unacceptable risk and other non-compliances. The process is facilitated by means of the electronic system Eudamed. See Articles 95 to 97 of Regulation 2017/745.

(299)  Article 18(3) of Regulation (EU) 2019/1020.

(300)  Unless the information provided by the economic operator leads the market surveillance authority to conclude that this is no longer necessary.

(301)  Cf. Article R31(1) of Annex I to Decision No 768/2008/EC.

(302)  Some legislation includes other specific entities that have obligations to fulfil, such as Directive 2013/53/EU on recreational craft and personal watercraft, which requires that a private importer, before putting the product into service, shall ensure that it has been designed and manufactured in accordance with the requirements set out in the relevant legislation. Market surveillance authorities should address such entities if they are the most relevant ones for a case. The definition of economic operator in Regulation (EU) 2019/1020 extends to such entities by referring to ‘any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation’ and gives non-exhaustive list of examples in recital 14. Further examples are the owner and the operator defined in Directive 2010/35/EU, and the dealer and a natural or legal person who engages in the storage, use, transfer, import, export or trade of explosive, referred to in Directive 2014/28/EU.

(303)  Product Safety Forum of Europe, a non-profit professional organisation for market surveillance authorities and officers from throughout the EEA; https://www.prosafe.org/

(304)  Regulation (EU) No 952/2013 (OJ L 269, 10.10.2013, p. 1); in particular Articles 46 and 47.

(305)  This notification should be made via ICSMS. A link between the ICSMS database and RAPEX prevents double encoding of information by national authorities for the purposes respectively of the safeguard clause process and rapid alerts according to Article 20 of Regulation (EU) 2019/1020.

(306)  Union harmonisation legislation aligned to Decision No 768/2008/EC provides for a safeguard procedure, which applies only in the event of disagreement between Member States over measures taken by a Member State. The aim is to ensure that proportionate and appropriate measures were taken when a non-compliant product is present in their territory and that similar approaches are taken in the different Member States. While in the past a notification of a risk of a product was notified, Commission had to open a case and elaborate an opinion, now, this burden has been removed and a safeguard case is only opened if a Member State or Commission objects to the measure taken by the notifying authority. Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission is required, except where non-compliance can be attributed to shortcomings of a harmonised standard.

(307)  This notification should be made via ICSMS. A link between the ICSMS database and RAPEX prevents double encoding of information by national authorities for the purposes respectively of the safeguard clause process and rapid alerts according to Article 20 of Regulation (EU) 2019/1020.

(308)  For ICSMS, see Point 7.6.5.

(309)  Under Article 20 of Regulation (EU) 2019/1020, the Rapid Alert System applies to products covered by Union harmonisation legislation.

(310)  In the field of medicinal products and medical devices, there is a specific information exchange system.

(311)  Adopted as Commission Implementing Decision (EU) 2019/417 of 8 November 2018 laying down guidelines for the management of the European Union Rapid Information System ‘RAPEX’ established under Article 12 of Directive 2001/95/EC on general product safety and its notification system (OJ L 73, 15.3.2019, p. 121). The Commission is in the process of drafting an EU wide Risk Assessment Methodology which builds on RAPEX guidelines, developed within the framework of the GPSD and extends risks assessment to products that can harm the health and safety of professional users or other public interests.

(312)  https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm

(313)  See recital 58 of Regulation (EU) 2019/1020.

(314)  An interface between ICSMS and RAPEX to avoid double encoding of data is already available.

(315)  See legislation relating to medical devices and in vitro diagnostic medical devices.

(316)  See Article 2(64) of Regulation 2017/745 for definition of an incident, and Article 2(65) for the definition of a serious incident.

(317)  This Chapter deals only with products subject to Union harmonisation legislation. The free movement of products not subject to Union harmonisation legislation is dealt by the Commission Notice - Guide on Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) C(2021)1457 and available here https://ec.europa.eu/docsroom/documents/44906/attachments/2/translations/en/renditions/native and https://ec.europa.eu/docsroom/documents/44906/attachments/3/translations/en/renditions/native

(318)  A more detailed description of the procedures to be followed in case of products presenting a risk to the health or safety of persons or to other aspects of public interest protection is provided in chapter 7.

(319)  Or the EEA Agreement, see Point 2.8.2.

(320)  The issues related to the WTO agreement are beyond the scope of the Guide.

(321)  Agreement between the European Community and Malta on conformity assessment and acceptance of industrial products (ACAA) (OJ L 34, 6.2.2004, p. 42).

(322)  OJ L 280, 16.10.1998, p. 1; OJ L 278, 16.10.2002, p. 19.

(323)  The full text of the MRA EU-Switzerland and specific provisions may be found on the homepage of the Commission:
https://ec.europa.eu/growth/single-market/goods/international-aspects-single-market/mutual-recognition-agreements_en

(324)  OJ L 280, 16.10.1998, p. 1; OJ L 278, 16.10.2002, p. 19.

(325)  Commission Notice Implementation Guide for the Protocol to the CETA Agreement between Canada, the European Union and its Member States regarding the mutual acceptance of the results of conformity assessment (OJ C 351, 1.9.2021, p. 1).




ANNEX 1
EU legislation referred to in the Guide (non-exhaustive list)







Horizontal Union harmonisation Act


Number
(amendment)


Reference in the OJ




Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93


765/2008



OJ L 218 of 13.8.2008





Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011


2019/1020



OJ L 169 of 25.6.2019





Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products


768/2008/EC



OJ L 218 of 13.8.2008





Regulation (EU) 2019/515 of the European Parliament and of the Council of 19 March 2019 on the mutual recognition of goods lawfully marketed in another Member State and repealing Regulation (EC) No 764/2008


2019/515



OJ L 91 of 29.3.2019





Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products


85/374/EEC (1999/34/EC)



OJ L 210 of 7.8.1985

(OJ L 141 of 4.6.1999)




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


2001/95/EC



OJ L 11 of 15.1.2002





Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation


1025/2012



OJ L 316 of 14.11.2012















Sectoral Union harmonisation Act


Number (amendment)


Reference in the OJ




Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (recast)


2014/35/EU



OJ L 96 of 29.3.2014





Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys


2009/48/EC



OJ L 170 of 30.6.2009





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


2014/30/EU



OJ L 96 of 29.3.2014





Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)


2006/42



OJ L 157 of 9.6.2006





Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC


2016/425



OJ L 81 of 31.3.2016





Directive 2014/31/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of non-automatic weighing instruments (recast)


2014/31/EU



OJ L 96 of 29.3.2014





Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (recast)


2014/32/EU



OJ L 96 of 29.3.2014





Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices


98/79/EC
(1882/2003)
(596/2009)
(2011/100/EU)
(1998/79)
(1998/79)



OJ L 331 of 7.12.1998

(OJ L 284 of 31.10.2003)
(OJ L 188 of 18.7.2009)
(OJ L 341 of 22.12.2011)
(OJ L 22 of 29.1.1999)
(OJ L 6 of 10.1.2002)




Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC


2017/745
(2020/561)
(2017/745)
(2017/745)



OJ L 117 of 5.5.2017

(OJ L 130 of 24.4.2020)
(OJ L 117 of 3.5.2019)
(OJ L 334 of 27.12.2019)




Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU


2017/746
(2017/746)
(2017/746)



OJ L 117 of 5.5.2017

(OJ L 117 of 3.5.2019)
(OJ L 334 of 27.12.2019)




Regulation (EU) 2016/426 of the European Parliament and of the Council of 9 March 2016 on appliances burning gaseous fuels and repealing Directive 2009/142/EC


2016/426



OJ L 81 of 31.3.2016





Directive 2014/28/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market and supervision of explosives for civil uses (recast)


2014/28/EU



OJ L 96 of 29.3.2014





Directive 2013/29/EU of the European Parliament and of the Council of 12 June 2013 on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles (recast)


2013/29/EU



OJ L 178 of 28.6.2013





Directive 2014/34/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)


2014/34/EU



OJ L 96 of 29.3.2014





Directive 2013/53/EU of the European Parliament and of the Council of 20 November 2013 on recreational craft and personal watercraft and repealing Directive 94/25/EC


2013/53/EU



OJ L 354 of 28.12.2013





Directive 2014/33/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to lifts and safety components for lifts (recast)


2014/33/EU



OJ L 96 of 29.3.2014





Regulation (EU) 2016/424 of the European Parliament and of the Council of 9 March 2016 on cableway installations and repealing Directive 2000/9/EC


2016/424



OJ L 81 of 31.3.2016





Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast)


2014/68/EU



OJ L 189 of 27.6.2014





Directive 2014/29/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of simple pressure vessels (recast)


2014/29/EU



OJ L 96 of 29.3.2014





Directive 2010/35/EU of the European Parliament and of the Council of 16 June 2010 on transportable pressure equipment


2010/35/EU



OJ L 165 of 30.6.2010





Council Directive of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers


75/324/EEC
94/1/EC
2008/47/EC
2013/10/EU
2016/2037/EU



OJ L 147 of 9.6.1975


OJ L 23 of 28.1.1994


OJ L 96 of 9.4.2008


OJ L 77 of 20.3.2013


OJ L 314 of 22.11.2016





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


2014/53/EU



OJ L 153 of 22.5.2014





Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products


2009/125/EC



OJ L 285 of 31.10.2009





Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC


(EU) 2016/1628
Corrigendum
(EU) 2020/1040



OJ L 252 of 16.9.2016


OJ L 231 of 6.9.2019


OJ L 231 of 17.7.2020





Directive 2000/14/EC of the European Parliament and of the Council of 8 May 2000 on the approximation of the laws of the Member States relating to the noise emission in the environment by equipment for use outdoors


2000/14/EC
2005/88/EC
219/2009



OJ L 162 of 3.7.2000


OJ L 344 of 27.12.2005


OJ L 87 of 31.3.2009





Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)


2011/65/EU



OJ L 174 of 1.7.2011





Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC


2014/90/EU



OJ L 257 of 28.8.2014





Directive 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (recast)


2016/797



OJ L 138 of 26.5.2016





Directive (EU) 2018/852 of the European Parliament and of the Council of 30 May 2018 amending Directive 94/62/EC of 20 December 1994 on packaging and packaging waste


2018/852



OJ L 150 of 14.6.2018





Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network


552/2004
1070/2009



OJ L 96 of 31.3.2004


OJ L 300 of 14.11.2009





Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU


2017/1369



OJ L 198 of 28.7.2017





Regulation (EU) No 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009


2020/740



OJ L 177 of 5.6.2020





Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003


2019/1009



OJ L 170 of 25.6.2019





Commission Delegated Regulation (EU) 2019/945 of 12 March 2019 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems


2019/945



OJ L 152 of 11.6.2019










ANNEX 2
Additional guidance documents






—


Guidance documents from the Expert Group on Toy Safety:
https://ec.europa.eu/growth/sectors/toys/safety/guidance_en










—


Measuring instruments and non-automatic weighing instruments:
https://ec.europa.eu/growth/single-market/goods/building-blocks/legal-metrology/measuring-instruments/measuring-instruments-guidance-documents_en










—


Chemicals:
http://echa.europa.eu/support/guidance










—


Low Voltage Directive - Guidelines on application and recommendations:
https://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive_en










—


Electromagnetic Compatibility Directive (EMC) – Guidance:
https://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive_en










—


Radio Equipment Directive (RED) Guidance:
https://ec.europa.eu/growth/sectors/electrical-engineering/red-directive_en










—


Medical Devices – Guidance documents, publications and factsheets:
https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_guidance_meddevs.pdf (old Directives)
https://ec.europa.eu/health/medical-devices-new-regulations/guidance_en
https://ec.europa.eu/health/medical-devices-new-regulations/publications_en (new Regulations)










—


RoHS 2 - Frequently asked questions:
http://ec.europa.eu/environment/waste/rohs_eee/events_rohs3_en.htm










—


Pressure Equipment Directive (PED) guidelines:
https://ec.europa.eu/growth/sectors/pressure-gas/pressure-equipment/directive_en










—


Machinery Directive - Guidance Documents:
https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en










—


Regulation on cableways - Guide to application:
https://ec.europa.eu/growth/sectors/mechanical-engineering/cableways_en










—


Directive on lifts - Guide to application:
https://ec.europa.eu/growth/sectors/mechanical-engineering/lifts_en










—


Regulation on Personal Protective Equipment - Guide to application:
https://ec.europa.eu/growth/sectors/mechanical-engineering/personal-protective-equipment_en










—


Directive on the noise emission in the environment by equipment for use outdoors - Guide to application, publications and studies:
https://ec.europa.eu/growth/sectors/mechanical-engineering/noise-emissions_en










—


Directive on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX) – Guidelines on the application (Third edition May 2020):
https://ec.europa.eu/growth/sectors/mechanical-engineering/atex_en










—


Guide to the practical application of the General Product Safety Directive:
http://ec.europa.eu/consumers/safety/prod_legis/index_en.htm










—


RAPEX Rapid Alert System Guidelines:
https://eur-lex.europa.eu/eli/dec/2019/417/oj










—


European standards – General framework:
https://ec.europa.eu/growth/single-market/european-standards_en










—


Vademecum on European standardisation in support of Union legislation and policies (SWD(2015) 205 final, 27.10.2015):
https://ec.europa.eu/growth/single-market/european-standards/vademecum-european-standardisation_en










—


Notice to stakeholders - Withdrawal of the United Kingdom and EU Rules in the field of Industrial Products:
https://ec.europa.eu/info/sites/info/files/notice_to_stakeholders_industrial_products.pdf









ANNEX 3
Useful web addresses






—


Single Market for Goods
https://ec.europa.eu/growth/single-market/goods_en










—


European standards
https://ec.europa.eu/growth/single-market/european-standards_en










—


Rapid Alert System for non-food products presenting a risk (RAPEX)
https://ec.europa.eu/safety-gate/#/screen/home









ANNEX 4
Conformity assessment procedures (modules from Decision No 768/2008/EC)








Modules


Manufacturer


Manufacturer or Authorised representative


Conformity assessment body




A (Internal production control)






—


Design + Production










—


The manufacturer carries out himself all checks in order to ensure the conformity of the products to the legislative requirements (no EU-type)












—


draws up the technical documentation










—


ensures compliance of the manufactured products to the legislative requirements












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation and other relevant information at the disposal of the national authorities






No involvement of conformity assessment body. The manufacturer carries out himself all checks a notified body would do




A1 (Internal production control plus supervised product testing)






—


Design + Production










—


A + tests on specific aspects of the product












—


draws up the technical documentation










—


ensures compliance of the manufactured products to the legislative requirements










—


carries out tests or has tests carried out on his behalf on one or more specific aspects of the product. In this respect and at his choice tests are carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer










—


where the tests are carried out under the responsibility of a notified body, he shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the decision of the (notified or in-house accredited) body and other relevant information at the disposal of the national authorities






Either notified body or in-house accredited body (manufacturer’s choice) (*1):






A)


In-house accredited body






—


carries out tests on one or more specific aspects of the product










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed














B)


Notified Body






—


supervises and assumes responsibility for tests carried out by the manufacturer or on his behalf on one or more specific aspects of the product










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed












A2 (Internal production control plus supervised product checks at random intervals)






—


Design + Production










—


A + product checks at random intervals












—


draws up the technical documentation










—


ensures compliance of the manufactured products to the legislative requirements










—


lodges an application for product checks with a single body of his choice










—


where the tests are carried out by a notified body, he shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the decision of the (notified or in-house accredited) body and other relevant information at the disposal of the national authorities






Either notified body or in-house accredited body(manufacturer’s choice ) (*1):






—


carries out product checks at random intervals determined by the body










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed








B (EC-type examination)






—


Design












—


draws up the technical documentation










—


ensures the conformity of the specimen(s) to the legislative requirements










—


Remark: As module B covers only the design phase, the manufacturer does not draft any declaration of conformity and may not affix the notified body’s identification number to the product












—


lodges an application for EU-type examination with a single notified body of his choice keeps the technical documentation and the EU-type examination certificate and other relevant information at the disposal of the national authorities










—


informs the notified body of all modifications to the approved type






Notified Body






—


examines the technical documentation and supporting evidence.










—


verifies that the specimen(s) have been manufactured in conformity to the legislative requirements.




In this respect, the legislator lays down which of the following ways must be used:






—


examination of a specimen, (production type);










—


examination of the technical documentation plus examination of specimen, (combination of production type and design type);










—


examination of the technical documentation, without examination of a specimen (design type)










—


carries out appropriate examinations and tests










—


draws up an evaluation report that may be released only upon agreement with the manufacturer










—


issues an EU-type examination certificate










—


informs its notifying authorities and the other bodies about the EU-type examinations it has performed










—


keeps record of its decisions and other relevant information








C (Conformity to type based on internal production control)






—


Production (follows B)










—


The manufacturer carries out himself all checks to ensure the conformity of the products to the EU-type.












—


ensures compliance of the manufactured products to the approved (under module B) EU-type and the legislative requirements










—


Remark: The reference to ‘internal production control’ in the title of the module refers to the manufacturer’s obligation to internally control its production in order to ensure product conformity against the EU-type approved under module B.












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B) and other relevant information at the disposal of the national authorities












—


No involvement of Conformity assessment body. The manufacturer carries out himself all checks a notified body would do








C1 (Conformity to type based on internal production control plus supervised product testing)






—


Production (follows B)










—


C + tests on specific aspects of the product












—


ensures compliance of the manufactured products to the approved (under module B) EU-type and the legislative requirements










—


Remark: The reference to ‘internal production control’ in the title of the module refers to the manufacturer’s obligation to internally control its production in order to ensure product conformity against the EU-type approved under module B.










—


carries out tests or has tests carried out on his behalf on one or more specific aspects of the product. In this respect and at his choice tests are










—


carried out either by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer










—


where the tests are carried out under the responsibility of a notified body, he shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the decision of the (notified or in-house accredited) body and other relevant information at the disposal of the national authorities






Either notified body or in-house accredited body (manufacturer’s choice ) (*1):






A)


In-house accredited body






—


carries out tests on one or more specific aspects of the product










—


Remark: the in-house accredited body takes into account the technical documentation but does not examine it, as it has been already examined under module B










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed














B)


Notified Body






—


supervises and assumes responsibility for tests carried out by the manufacturer or on his behalf on one or more specific aspects of the product










—


Remark: the notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B.










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed












C2 (Conformity to type based on internal production control plus supervised product checks at random intervals)






—


Production (follows B)










—


C + product checks at random intervals












—


ensures compliance of the manufactured products to approved (under module B) EU-type and the legislative requirements










—


Remark: The reference to ‘internal production control’ in the title of the module refers to the manufacturer’s obligation to internally control its production in order to ensure product conformity against the EU-type approved under module B.










—


lodges an application for product checks with a single body of his choice










—


where the tests are carried out by a notified body, he shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process












—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the decision of the (notified or in-house accredited) body and other relevant information at the disposal of the national authorities






Either notified body or in-house accredited body(manufacturer’s choice ) (*1):






—


carries out product checks at random intervals determined by the body










—


Remark: the in-house accredited body or notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B










—


keeps record of its decisions and other relevant information










—


informs authorities and the other bodies about the examinations it has performed








D (Conformity to EU-type based on quality assurance of the production process)






—


Production (follows B)










—


Quality assurance for manufacturing and inspection of final product












—


operates an approved quality system for production, final product inspection and testing of the products in order to ensure compliance of the manufactured products to the approved (under module B) EC-type and the legislative requirements




The quality system must include the following elements and has to be documented: quality objectives, organisational structure, manufacturing and quality control techniques, tests (carried out before, during and after manufacturing), quality records, monitoring methods






—


fulfils the obligations arising out of the quality system










—


ensures compliance of the manufactured products to approved (under module B) EU-type and the legislative requirements












—


lodges an application for the assessment of the quality system with a single notified body of his choice










—


keeps the notified body informed of any change to the quality system










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


performs periodic audits in order to assess and survey the quality system




Audits include: review of the technical documentation, control of the quality system, inspections, product tests






—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system examinations it has performed








D1 (Quality assurance of the production process)






—


Design + Production










—


Quality assurance for manufacturing and inspection of final product










—


Used like D without module B (No EU-type )












—


draws up the technical documentation










—


operates an approved quality system for production, final product inspection and testing of the products in order to ensure compliance of the manufactured products to the legislative requirements




The quality system must include the following elements and has to be documented: quality objectives, organisational structure, manufacturing and quality control techniques, tests (carried out before, during and after manufacturing), quality records, monitoring methods






—


fulfils the obligations arising out of the quality system










—


ensures compliance of the manufactured products to the legislative requirements












—


lodges an application for the assessment of the quality system with a single notified body of his choice










—


keeps the notified body informed of any change to the quality system.










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


performs periodic audits in order to assess and survey the quality system




Audits include: review of the technical documentation, control of the quality system, inspections, product tests






—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system examinations it has performed








E (Conformity to EU-type based on product quality assurance)






—


Production (follows B)










—


Final product (=production without the manufacturing part) quality assurance










—


Like D without the part of the quality system that focuses on the manufacturing process












—


operates an approved quality system for final product inspection and testing in order to ensure compliance of the manufactured products to the approved (under module B) EU-type and the legislative requirements




The quality system must include the following elements and has to be documented: quality objectives, organisational structure, tests (carried out after the manufacturing), quality records, monitoring methods






—


Remark: tests carried out before/ during manufacturing, and manufacturing techniques, are not part of the quality system under module E (as it is the case for modules D, D1), because module E targets the final product quality and not the quality of the whole production process (as it is the case for modules D, D1)










—


fulfils the obligations arising out of the quality system










—


ensures compliance of the manufactured products to approved (under module B) EU-type and the legislative requirements












—


lodges an application for the assessment of the quality system with a single notified body of his choice










—


keeps the notified body informed of any change to the quality system










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


performs periodic audits in order to assess and survey the quality system




Audits include: control of the quality system, inspections, product tests Remark: the notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B






—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system examinations it has performed








E1 (Quality assurance of final product inspection and testing)






—


Design + Production










—


Final product (=production without the manufacturing part) quality assurance










—


Like D1 without the part of the quality system that focuses on the manufacturing process










—


Used like E without module B (No EU- type)












—


draws up the technical documentation










—


operates an approved quality system for final product inspection and testing in order to ensure compliance of the manufactured products to the legislative requirements




The quality system must include the following elements and has to be documented: quality objectives, organisational structure, tests (carried out after the manufacturing), quality records, monitoring methods






—


Remark: tests carried out before/ during manufacturing, and manufacturing techniques, are not part of the quality system under module E1 (as it is the case for modules D, D1), because module E1 (like module E) targets the final product quality and not the quality of the whole production process (as it is the case for modules D, D1)










—


fulfils the obligations arising out of the quality system.










—


ensures compliance of the manufactured products to the legislative requirements












—


lodges an application for the assessment of the quality system with a single notified body of his choice










—


keeps the notified body informed of any change to the quality system










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


performs periodic audits in order to assess and survey the quality system




Audits include: review of the technical documentation, control of the quality system, inspections, product tests






—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system examinations it has performed








F (Conformity to EU-type based on product verification)






—


Production (follows B)










—


Product examination (testing of every product or statistical checks) in order to ensure conformity to EU-type










—


Like C2 but the notified body carries out more detailed product checks.












—


ensures compliance of the manufactured products to approved (under module B) EU-type and the legislative requirements










—


in case where statistical verification is performed, takes all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots












—


lodges an application for product checks with a single notified body of his choice










—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation of the approved type (established under module B), the certificate of conformity and other relevant information at the disposal of the national authorities










—


Upon permission of the notified body affixes its identification number






Notified Body






—


carries out appropriate examinations and tests (testing of every product or statistical checks)










—


In the scenario of statistical verification and if a lot is rejected, the notified body shall take appropriate measures to prevent that lot’s being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures










—


Remark: the notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B










—


issues a certificate of conformity










—


affixes its identification number or delegates to the manufacturer the affixing of its identification number










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the examinations it has performed








F1 (Conformity based on product verification)






—


Design + Production










—


Product examination (testing of every product or statistical checks) in order to ensure conformity to legislative requirements)










—


Used like F without module B (no EU- type)












—


draws up the technical documentation










—


ensures compliance of the manufactured products to approved (under module B) EU-type and the legislative requirements










—


in case where statistical verification is performed, takes all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and shall present his products for verification in the form of homogeneous lots












—


lodges an application for product checks with a single notified body of his choice










—


affixes the CE Marking










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the certificate of conformity and other relevant information at the disposal of the national authorities










—


Upon permission of the notified body affixes its identification number






Notified Body






—


carries out appropriate examinations and tests (testing of every product or statistical checks)










—


In the scenario of statistical verification and if a lot is rejected, the notified body shall take appropriate measures to prevent that lot’s being placed on the market. In the event of the frequent rejection of lots the notified body may suspend the statistical verification and take appropriate measures.










—


issues a certificate of conformity










—


affixes its identification number or delegates to the manufacturer the affixing of its identification number










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the examinations it has performed








G (Conformity based on unit verification)






—


Design + Production










—


Verification of every individual product in order to ensure conformity to legislative requirements (no EU-type)












—


draws up the technical documentation










—


ensures compliance of the manufactured products to the legislative requirements










—


lodges an application for product checks with a single notified body of his choice












—


affixes the CE marking










—


affixes, under the responsibility of the notified body the latter’s identification number










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the certificate of conformity and other relevant information at the disposal of the national authorities






Notified Body






—


carries out appropriate examinations










—


issues a certificate of conformity










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the examinations it has performed








H (Conformity based on full quality assurance)






—


Design + Production










—


Full quality assurance










—


No EU-type












—


draws up the technical documentation










—


operates an approved quality system for production, final product inspection and testing of the products.










—


The quality system must include the following elements and has to be documented: quality objectives, organisational structure, manufacturing and quality control techniques, verification techniques for product design, tests (carried out before, during and after manufacturing), quality records, monitoring methods










—


fulfils the obligations arising out of the quality system










—


ensures compliance of the manufactured products to the legislative requirements












—


lodges an application for the assessment of the quality system with a single notified body of his choice










—


keeps the notified body informed of any change to the quality system.










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


performs periodic audits in order to assess and survey the quality system










—


Audits include: review of the technical documentation, control of the quality system, inspections, product tests










—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system examinations it has performed








H1 (Conformity based on full quality assurance plus design examination)






—


Design + Production










—


Full quality assurance plus design examination in order to ensure conformity to legislative requirements










—


No EU-type but EC-design examination certificate










—


Like module H plus issuing of a EC design examination certificate












—


draws up the technical documentation










—


operates an approved quality system for production, final product inspection and testing of the products.










—


The quality system must include the following elements and has to be documented: quality objectives, organisational structure, manufacturing and quality control techniques, verification techniques for product design, tests (carried out before, during and after manufacturing), quality records, monitoring methods










—


fulfils the obligations arising out of the quality system










—


ensures compliance of the manufactured products to the approved EC-de- sign and the legislative requirements












—


lodges an application for EC design examination with the same notified body that will assess the quality system










—


lodges an application for assessment of his quality system with the notified body of his choice










—


keeps the notified body informed of any modification to the approved de- sign and of any change to the quality system.










—


draws up a written declaration of conformity and keeps it together with the technical documentation, the EC design examination certificate, the quality system approval and other relevant information at the disposal of the national authorities










—


affixes the CE Marking










—


affixes, under the responsibility of the notified body, the latter’s identification number






Notified Body






—


examines the product design










—


issues an EC design examination certificate










—


performs periodic audits in order to assess and survey the quality system










—


Audits include: review of the technical documentation, control of the quality system, inspections, product tests










—


notifies its decision about the quality assurance system to the manufacturer (the notification shall contain the conclusions of the audit and the reasoned assessment decision)










—


keeps record of its decisions and other relevant information










—


informs its notifying authorities and the other bodies about the quality system and EC-design examinations it has performed










(*1)  The legislator may restrict manufacturer’s choice





ANNEX 5
Frequently Asked Questions on CE marking

What does the CE marking on a product indicate?

By affixing the CE marking to a product, the manufacturer declares on his sole responsibility that the product is in conformity with the essential requirements of the applicable Union harmonisation legislation providing for its affixing and that the relevant conformity assessment procedures have been fulfilled. Products bearing the CE marking are presumed to be in compliance with the applicable Union harmonisation legislation and hence benefit from free circulation in the European Market.

Is a product affixed with the CE marking always produced in the EU?

No. The CE marking only signals that all essential requirements have been fulfilled when the product was manufactured. The CE marking is not a mark of origin, as it does not indicate that the product was manufactured in the European Union. Consequently, a product affixed with the CE marking may have been produced anywhere in the world.

Are all CE marked products tested and approved by authorities?

No. In fact, the assessment of the conformity of the products with the legislative requirements applying to them is the sole responsibility of the manufacturer. The manufacturer affixes the CE marking and drafts the EU Declaration of Conformity. Only products which are regarded as presenting a high risk to the public interest, e.g. pressure vessels, lifts and certain machine tools, require conformity assessment by a third party, i.e. a notified body.

Can I, as a manufacturer, affix my products with the CE marking myself?

Yes, the CE marking is always affixed by the manufacturer himself or his authorised representative after the necessary conformity assessment procedure has been performed. This means that, before being affixed with the CE marking and being placed on the market, the product must be subject to the conformity assessment procedure provided for in one or more of the applicable Union harmonisation acts. The latter establish whether the conformity assessment may be performed by the manufacturer him- self or if the intervention of a third party (the notified body) is required.

Where should the CE marking be affixed?

The marking shall be affixed either to the product or to the product’s data plate. When that is not possible due to the nature of the product, the CE marking shall be affixed to the packaging and/or to any accompanying documents.

What is a manufacturer’s Declaration of Conformity?

The EU Declaration of Conformity (EU DoC) is a document in which the manufacturer, or his authorised representative within the European Economic Area (EEA), indicates that the product meets all the necessary requirements of the Union harmonisation legislation applicable to the specific product. The EU DoC shall also contain the name and address of the manufacturer along with information about the product, such as the brand and serial number. The EU DoC must be signed by an individual working for the manufacturer or his authorised representative, and the employee’s function shall also be indicated.
Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EE Declaration of Conformity.

Is CE marking mandatory, and if so; for what products?

Yes, CE marking is mandatory. However, only the products that are covered by the scope of one or more of the Union harmonisation acts providing for CE marking shall be affixed with it in order to be placed on the Union market. Examples of products that fall under Union harmonisation acts providing for CE marking are toys, electrical products, machinery, personal protective equipment and lifts. Products that are not covered by CE marking legislation shall not bear the CE marking.
Information the products that are CE marked and the Union harmonisation legislation providing for CE Marking under
https://ec.europa.eu/growth/single-market/ce-marking_en

What is the difference between the CE marking and other markings, and can other markings be affixed on the product if there is a CE marking?

The CE marking is the only marking that indicates conformity to all the essential requirements of the Union harmonisation legislation that provide for its affixing. A product may bear additional markings provided that they do not have the same meaning as the CE marking, that they are not liable to cause confusion with the CE marking and that they do not impair the legibility and visibility of the CE marking. In this respect, other markings may be used only if they contribute to the improvement of consumer protection and are not covered by harmonisation legislation of the European Union.

Who supervises the correct use of the CE marking?

In order to guarantee the impartiality of market surveillance operations, the supervision of the CE marking is the responsibility of public authorities in the Member States in cooperation with the European Commission.

What are the sanctions for counterfeiting the CE marking?

The procedures, measures and sanctions that apply to counterfeiting of the CE marking are laid down in Member State’s national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and, in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation before being obliged to take the product off the market.

What implications may the affixing of the CE marking have for the manufacturer/importer/distributor?

While manufacturers are responsible for ensuring product compliance and affixing the CE marking, importers and distributors also play an important role in making sure that only products complying with legislation and bearing the CE marking are placed on the market. Not only does this help to reinforce the EU’s health, safety and environmental protection requirements, it also supports fair competition with all players being held accountable to the same rules.
When products are produced in third countries and the manufacturer is not represented in the EEA, importers must make sure that the products placed by them on the market comply with the applicable requirements and do not present a risk to the European public. The importer must verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request.
Thus, importers must have an overall knowledge of the respective Union harmonisation acts and are obliged to support national authorities should problems arise. Importers should have a written assurance from the manufacturer that they will have access to the necessary documentation – such as the EU Declaration of Conformity and the technical documentation – and be able to provide it to national authorities, if requested. Importers should also make sure that contact with the manufacturer can always be established.
Further along in the supply chain, distributors play an important role in ensuring that only compliant products are on the market and must act with due care to ensure that their handling of the product does not adversely affect its compliance. The distributor must also have a basic knowledge of the legal requirements – including which products must bear the CE marking and the ac- companying documentation – and should be able to identify products that are clearly not in compliance.
Distributors must be able to demonstrate to national authorities that they have acted with due care and have affirmation from the manufacturer or the importer that the necessary measures have been taken. Furthermore, a distributor must be able to assist the national authority in its efforts to receive the required documentation.
If the importer or distributor markets the products under his own name, he then takes over the manufacturer’s responsibilities. In this case, he must have sufficient information on the design and production of the product, as he will be assuming the legal responsibility when affixing the CE marking.

Where can I find more information?

Information about CE marking, the products that are CE marked, the Union harmonisation legislation providing for CE Marking and the steps to follow under
https://ec.europa.eu/growth/single-market/ce-marking_en
Economic operators may contact the Enterprise Europe Network under
https://een.ec.europa.eu/