Updated: Jun 20
This Guide is part 2 of a number of guides which will be released weekly and 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 CE Marking
Many products require the CE Mark before they can be sold in the EU. The CE Mark indicates that a product has been assessed by the manufacturer and meets the essential health and safety requirements enshrined in what is commonly considered the CE Marking Directives and Regulations. These directives and regulations are legislative acts adopted by the EU as a whole and are considered to be “harmonized”, which means that they apply across all EU member states and are mandatory. (Note however member states can have additional requirements in some cases). In order to attest that a product fulfils the harmonized EU legislation, the EU has listed a number of requirements throughout the supply chain defining the roles and responsibilities of an ‘economic operators’ which we are going to discuss below
See guide part 3 next week on CE Marking Requirements
You should note that this guidance represents the CE Marking Authority's interpretation of the legislative framework and does not have legal force.
(i.e. manufacturers, importers, distributors, Fulfilment Service providers and authorised representatives)
— 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 placing it on the market under his own name or trademark. 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.
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. 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.
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 and certificates necessary to demonstrate the conformity of the product, but these do not need to be under his name.
The Lifts Directive 95/16/EC 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 and who affixes the CE marking and draws up the EC declaration of conformity. 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.
Manufacturers Main Responsibilities
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 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 as required by the applicable Union harmonisation legislation, in a language easily understood by consumers and other end-users, as determined by the Member State concerned. Unless otherwise specified in specific legislation, instructions and safety information need to be provided, 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;
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 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 three elements: his (1) name, (2) registered trade name or registered trade mark and (3) a single contact postal address 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 (. 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) 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, or use an independent consultant
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
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, 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 ‘GPSD Business Application’ to facilitate practical aspects of this obligation
Upon a reasoned request, 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. Manufacturers must cooperate with the authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. Manufacturers must on request by 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. 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. 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
AUTHORISED REPRESENTATIVE OBLIGATIONS
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 (A manufacturer established outside the European Union is not obliged to have an authorised representative).
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 and the Union harmonisation act in question, the authorised representative can also, for instance, be appointed to perform tasks 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.
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
• 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. 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. 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.
These obligations are meant to make sure that the importers are aware of their responsibility to place only compliant products on the market. 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 three elements: his
(2) registered trade name or trade mark and
(3) 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 on the accompanying documentation. 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 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. The importer has to cooperate with that authority and upon a reasoned request, 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.
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.
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 in relation to the applicable requirements. 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 importer 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:
• 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) and by instructions and safety information 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, (2) registered trade name or trademark and (3) 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, 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.
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;
2. assist market surveillance authorities in identifying the manufacturer or importer responsible for the product;
3. upon a reasoned request 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;
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.
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.
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.
FULFILMENT SERVICE PROVIDER OBLIGATIONS
The E-Commerce Directive 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. Hosting activities are activities such as storing information provided by the recipient of the service, e.g. web shops and 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), 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. As an example of a distinct policy area still with certain similarities, a court can order service providers to make sure that certain websites, which contain exclusively copyright-infringing content or fake products, are blocked from users of the given Member State.
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. Nevertheless, market surveillance authorities should base their activities on the applicable provisions of Regulation (EC) No 765/2008 and relevant Union harmonisation legislation and, thus, target, in the first place, the responsible economic operator. 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.
The term “content” covers an offer of a product online (e.g. its picture, description, etc.). The term “illegal activity” refers to activities covered both by criminal and administrative law. The exemption of liability refers to civil, administrative and criminal liability for all types of illegal activities initiated by third parties online, such as copyright and trademarks piracy, unfair commercial practices, etc. The Directive seeks to strike a fair balance between all interests at stake. The legal basis for notifying and requiring hosting providers to remove/disable access to illegal content is contained in the national transpositions of the E-commerce Directive. Moreover, most online intermediaries have developed their own reporting mechanisms.
If you require CE Marking assistance contact the team on the link below