The obligations of manufacturers under the EU’s Single Market product safety legislation are well understood. For manufacturers based in the EU, it’s simply the case that they are responsible for all aspects of compliance and if the Market Surveillance Authorities (MSA) within the EU need to identify someone to take responsibility for faulty products or incorrect paperwork then the trail of responsibility leads straight to, and stops at, the manufacturer’s door.
If the manufacturer of a CE marked product is based outside the EU, the situation is more complex. In theory, the obligations of other economic operators such as importers and distributors are also clearly defined in the various directives and regulations which implement the CE marking (and other markings such as the marine equipment wheel mark). However, in practice who is actually responsible for doing what can be rather more complex than it at first appears. This page discusses the responsibilities of the various parties and should help you to understand what you need to do to ensure that your CE marked products are properly represented in the Single Market.
IMPORTANT - the following discussion does not deal with the specific requirements for medical devices, which are subject to some different and additional requirements.
Definitions
It’s useful to start with some definitions. The following are drawn from “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” better known as ‘the New Legislative Framework” (NLF):
- ‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his name or trademark;
- ‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
- ‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;
- ‘distributor’ shall mean any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market;
- ‘economic operators’ shall mean the manufacturer, the authorised representative, the importer and the distributor;
Note the phrase ‘natural or legal person’. A ‘natural person' is an identifiable individual; a ‘legal person' is a corporate body such as a limited company.
Decision 768/2008 does not actually apply to manufacturers directly – it’s a template of rules and boiler plate text for drafting new and updated Directives and Regulations so its requirements apply to legislators rather than directly to ‘economic operators’. Nevertheless, it has formed the template for all of the CE marking legal instruments which have come along since, so for the purposes of a general discussion it’s easier to refer to the NLF provisions rather than to individual directives and regulations.
(For clarity, the NLF provisions appear in the EMC, Low Voltage, Radio Equipment, Restriction of Hazardous Substances (RoHS), Pressure Equipment, Toy Safety, and ATEX directives (among others) and the Personal Protective Equipment, Gas Appliances and Construction Products regulations. The major omission where the NLF provisions have yet to be included is the Machinery Directive, which is discussed in more detail below.)
Obligations of Economic Operators
The NLF outlines obligations for each of the defined economic operators:
Manufacturers are required to:
- Design products so that they meet the requirements set out in the applicable directives;
- Draw up the required technical documentation and keep it for the required period;
- Apply the correct conformity assessment procedures;
- Establish appropriate controls to ensure that all products produced in series production comply with the requirements;
- Take the necessary measures to deal with non-conforming product;
- Mark the product with their name and address;
- Ensure that suitable information and instructions are provided with the product;
- Cooperate with the authorities in the event that enforcement action is mounted against them.
Authorised Representatives are required to (at least):
- Keep the Declaration of Conformity and the technical documentation at the disposal of the MSAs;
- Cooperate with the authorities in the event that enforcement action is mounted against them;
- Perform any other tasks identified in the written mandate agreed between them and the manufacturer.
Importers are required to:
- Ensure that the CE marked product is properly compliant with the CE marking requirements before placing on the market;
- Identify themselves as the importer and provide their name and address on the product, packaging or instructions for use (IFU);
- Ensure IFU in the language of the end user are provided;
- Store and transport the products in such a way as to ensure they remain fit for purpose;
- Keep records of any complaints, problems etc. and act on them appropriately;
- If necessary, recall products which are faulty;
- Keep copies of the Declaration of Conformity and sales records for at least 10 years after the last date on which the product was sold;
- Respond to requests for information and co-operation from MSA and ensure that the product’s technical documentation is available for the MSA on request.
A distributor must:
- Verify that the product bears the CE marking;
- Ensure the product is accompanied by the required documents and IFU in a language which can be easily understood by consumers and other end-users;
- Ensure the goods are identified with model, serial and/or batch identification numbers;
- Ensure that the name and address of the manufacturer (or, if that address is not within the EU, the name and address of either their Authorised Representative or the importer) is on the goods;
- Take the necessary steps to ensure that goods conform to the applicable requirements;
- Inform the manufacturer or the importer, and the MSA, if goods are unsafe;
- Store and transport the products in such a way as to ensure they remain fit for purpose;
- Take any necessary corrective action required to ensure products comply with the applicable CE marking requirements;
- If necessary, to withdraw and/or recall non complying product;
- Keep copies of the documentation required to demonstrate these obligations have been met;
- Respond to requests for information and co-operation from MSA.
Other factors
Before we look more closely at the options available to non-resident manufacturers, there are some additional points to consider:
1. Appointment of an Authorised Representative (AR) is optional. Manufacturers are required to identify an Economic Operator within the EU, but it does not necessarily have to be an AR - it could be an importer or a Fulfilment Service Provider (see ‘The Market Surveillance Regulation’ below). Usually, appointing an AR gives the most flexibility (see Advantages of appointing an Authorised Representative as the Economic Operator below).
2. If the manufacturer does appoint an AR then the AR must be mandated to perform at least the tasks listed for the AR in the previous section.
3. Unless a product is sold directly from a manufacturer outside the EU to an end user within the EU then there will always be an importer somewhere in the transaction. Importers do not need to be formally appointed by the manufacturer – anyone who is not the manufacturer who places product from outside the EU on the EU market becomes an importer by default.
4. The importer identified for the purposes of the Single Market requirements is not necessarily the same person as the importer who deals with customs, transport arrangements, warehousing etc.
5. Most of the obligations for the different economic operators can be delegated to others. For example, a ‘manufacturer’ can simply be a branding operation who delegates the responsibility for the safe design of a product to another company who actually designs and assembles the product on their behalf.
Importer role
The importer is the person who ‘first places the product on the market’. In this context, ‘first places on the market’ means they are the person responsible for bringing the product into the EU. This refers to the specific units – if one company imports a batch of products and then another company independently imports a second batch, both are importers and they are each responsible for the specific units which they were responsible for placing on the market.
Placing on the market does not necessarily entail physically shipping goods – it can simply mean offering the product for sale in a catalogue, on a website or in response to an enquiry from a potential buyer. Often it will actually be the manufacturer who offers the product for sale and if they are based within the EU then they will be placing the product on the market and will have direct responsibility for compliance with all the Single Market requirements. However, if the manufacturer is based outside the EU then the first person (natural or legal) who is in the supply chain and based within the EU will automatically become the importer.
The importer does not necessarily have to have any relationship with the manufacturer – they could just purchase the products through an agent or distributor in the manufacturer’s home country without the knowledge or co-operation of the manufacturer and then re-sell them within the EU. If they do this, they could potentially run into problems later since they may well find themselves unable to deliver all of the information required of them by the MSA.
Under the NLF, one of the common requirements is that the importer must be identified with their name and address on the product, its IFU or its packaging. This is so that the MSA know who to contact in the event of a problem with the product. This requirement has been in place since 2016 but has been widely ignored until recently, especially for goods being shipped into the Single Market via the UK. Up until the end of 2020, manufacturers and importers based in the UK were still within Europe for the purposes of this requirement and there were few official checks on goods being transferred from the UK into other parts of the EU. Now that the UK has become a ‘third country’, UK based manufacturers can no longer use their UK address as a European contact point and instead they must either appoint an AR or they will have to identify the companies which were previously acting as their distributors in Europe as importers. Furthermore, shipments from the UK to Europe are subject to much more scrutiny by customs as they cross the border.
Click here for further information on the effects of Brexit and the requirement to appoint an AR in the UK.
Authorised Representative role
In contrast with the role of importer, the AR is required to have a relationship with the manufacturer, and the terms of that relationship must be documented in a mandate agreed between the manufacturer and the AR.
The NLF says nothing about the relationship between an importer and the manufacturer’s Authorised Representative (AR) but the primary function of an AR is to act as a contact point through which the MSA can obtain the technical documentation for the product from the manufacturer. The AR may have other responsibilities assigned to them in the mandate given to them by the manufacturer, and these can include marking the AR’s name and address on the product as the EU based contact point.
One area where there is still inconsistency is in the need for the AR’s details to be given on the Declaration of Conformity. If the mandate between the manufacturer and the AR includes an obligation on the AR to sign the Declaration then clearly the AR’s details must be provided. However, it’s not requirement for the AR to sign the Declaration, this is merely optional and if the AR does not sign the Declaration then the manufacturer must do so.
Some of the NLF directives require the Manufacturer or their AR to have their name and address on the declaration, others say the manufacturer and the AR details must be present. The following table summarises this for some of the directives.
Directive / Regulation | Manufacturer … authorised representative |
Machinery Directive | AND |
Low Voltage Directive | OR |
EMC Directive | OR |
Noise Emission Directive | OR |
ATEX Directive | AND |
Construction Products Regulation | AND |
Ecodesign Directive | OR |
Medical Devices Regulations | AND |
PPE Regulation (EU) 2016/425 | AND |
Pressure Equipment Directive | AND |
Radio Equipment Directive | OR |
RoHS Directive | OR |
Our recommendation is to always include both the manufacturer’s name and address and the AR’s: it seems highly unlikely that this would be seen as an actionable non-compliance by the MSA.
Machinery Directive specific requirements
Due to an accident of timing, the Machinery Directive 2006/42/EC was not included in the NLF update which resulted in nearly all of the CE marking directives being updated in 2016. As a result, although the Machinery Directive contains some of the same definitions for economic operators it is less explicit than the NLF directives on the obligations of those operators. In particular, it does not require the importer’s name to be identified on the product (although the name and address of the Authorised Representative is required to be on the product, if one has been appointed).
It also contains a provision which is not found in any other directive or regulation:
The EC declaration of conformity must contain the following particulars:
…
name and address of the person authorised to compile the technical file, who must be established in the Community;
In common with the provisions of the NLF directives, this requirement is about ensuring that MSA within the EU have access to the technical documentation which shows how the manufacturer has complied with the applicable requirements. For a manufacturer who has appointed an Authorised Representative, or who has a stable long-term relationship with a specific importer, it’s easy to see how they can fulfil this requirement, but for manufacturers selling direct to end users or who do not have a long-term relationship with an importer, they need to find a person (natural or legal) within the EU who is willing to allow them to put their name and address on the Declaration.
The other consideration here is that machinery which is only within scope of the Machinery Directive is actually fairly unusual. Most machinery will also have electrical equipment which brings it within scope of the EMC, RoHS and possibly other NLF directives. Thus the requirement for identifying an AR or an importer still applies.
General Product Safety Directive
The General Product Safety Directive (GPSD) is a catch-all requirement which is intended to regulate the safety of consumer products not covered by more specific legislation. It also contains certain provisions about the powers of MSA which supplement the requirements in the more specific Single Market legislation.
The GPSD does not require CE marking for products within its scope.
Under the GPSD, products must have a ‘producer’ who takes responsibility for placing the product on the market. A producer can be a manufacturer based within the EU, a ‘manufacturer’s representative’ based within the EU if the manufacturer is based outside, or an importer into the EU.
Under the GPSD, the producer must provide:
“an indication, by means of the product or its packaging, of the identity and details of the producer”
Or in other words there needs to be the name and address of an EU based manufacturer’s representative or importer accompanying the product, thus in effect extending the requirement for an identifiable economic operator within the EU to most simple consumer products.
The Market Surveillance Regulation
In order to clarify the roles of the various economic operators identified in the NLF, in 2019 the EU enacted 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, better known as “the Market Surveillance Regulation” (MSR). This comes fully into force within the EU on 16th July 2021. It applies to products within scope of any of the CE marking directives/regulations, including machinery.
So far as manufacturers are concerned, the primary function of the MSR is to make it clear that there must be an economic operator to take responsibility for the product within the EU. The economic operator can be any one of the first three (manufacturer, importer, authorised representative) defined in the NLF, or it can be a newly defined entity known as a ‘fulfilment service provider’.
The definition of a fulfilment service provider (FSP) is as follows:
any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services… or freight transport services;
The creation of the status of FSP and its inclusion within the MSR makes space for a new requirement on manufacturers to appoint an economic operator even where they are selling direct to end users. (The need to appoint an economic operator is especially relevant when selling direct to end users; in other situations the EU economic operator will arise by default.)
The role of the economic operator is to:
- Verify that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up;
- Keep the declaration of conformity or declaration of performance at the disposal of market surveillance authorities;
- Ensure that the technical documentation can be made available to those authorities upon request;
- Respond to a reasoned request from MSA by providing the authority with all information and documentation necessary to demonstrate the conformity of the product;
- Ensure documents are in a language which can be easily understood by MSA;
- Informing the market surveillance authorities if there is reason to believe that a product presents a risk;
- Cooperate with MSA;
- Make sure that corrective action is taken to remedy any case of non-compliance with the requirements set out in the applicable Single Market legislation.
- Identify their name and address on the product, its documentation or the packaging.
It can be seen that these obligations very closely mirror those of the importer under the NLF. The net effect of the Regulation, therefore, is to clarify that if a manufacturer based outside the EU appoints an AR, the AR can take on the responsibilities which were previously the importer’s sole responsibility.
Strictly speaking, the MSR does not apply to products only covered by the GPSD, but the requirement for identifying a ‘producer’ contained within the GPSD is closely aligned to the requirement to identify an economic operator under the MSR.
Whose name and address goes on the product?
The manufacturer's identifying details should always be given on the product itself, and only when this is not possible for technical reasons is it permissible for the information to be on the IFU or the packaging. However, the requirement for the additional details of the economic operator, importer etc. is more complex.
The MSR uses the phrase "Notwithstanding any obligations set out in applicable Union harmonisation legislation…” so its requirements are additional to those of the specific directives, not a replacement for them. Apparently, therefore, the obligation for the importer to put their name and address on the product remains even if another economic operator is also identified.
The NLF wording states:
"Importers shall indicate their name, registered trade name or registered trade mark and 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."
Note that this is an obligation on the importer, not on the manufacturer. On the face of it, this is potentially a duplication of effort but it makes sense particularly in the context of goods being imported without the knowledge or co-operation of the manufacturer. It remains to be seen how the MSA will interpret this obligation, and it may be that a case can be made that so long as the importer can be identified by the information available to the AR then just providing contact details for the AR is sufficient. This is alluded to in the Blue Guide which says (§4.2.2.2):
The [requirement to give the importer's address] 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.
This could be useful by avoiding a proliferation of names and addresses on the product in the situation where a manufacturer has more than one importer, but for now at least it is legally untested.
The NLF wording makes it clear that the importer name and address does not have to be marked on the product, although this is preferred. However, the wording quoted above indicates a requirement for the importer details to accompany the product in a way that ensures it reaches the end user.
The wording of the MSR is different (Article 4(4)):
“… the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator… shall be indicated on the product or on its packaging, the parcel or an accompanying document.”
Our interpretation of this wording is that the information is required on the product itself, or on its packaging, but also on the shipping parcel or in the shipping paperwork. This is so that the MSA (particularly customs officers) can quickly identify who is responsible for a shipment of goods. It should be noted that Article 26 of the MSR gives the authorities power to impound goods which do not carry the required marking.
Advantages of appointing an Authorised Representative as the Economic Operator.
Under the MSR, a manufacturer based outside the EU has to identify one of three types of economic operator (authorised representative, importer, fulfilment service provider).
Most manufacturers will probably want to appoint an AR rather than rely on their importer or a FSP, for several reasons:
- they may not want their importer to see all their technical documentation in the event of a MSA action;
- their importer(s) may be reluctant to be put in a position where they have to deal with an MSA action;
- a manufacturer may have several importers and each will need to have their name and address on the units which they have imported. Appointing an AR could mean that only one address is required;
- EU importers will generally be much happier to trade with a non-EU manufacturer who has appointed an AR to specifically handle regulatory responsibilities, which is not an area in which many importers are experts.
Conformance does not provide an Authorised Representative service, but our sister company "Authorised Representative Service' does. With offices in the UK and Ireland, Authorised Representative Service can provide a one-stop-shop for all manufacturers and importers no matter where they are based. Please contact Authorised Representative Service directly, or contact Conformance for details.
