Now that the UK has left the EU, new requirements for identifying who is responsible for placing products on the UK market have come into force. This page discusses where those requirements come from and what they say.
Click here for information on the requirement for an Authorised Representative within the EU.
The UK has now left the EU completely. In future, Great Britain (GB) will make its own decisions about the content of its product safety legislation although Northern Ireland remains within the Single Market and will continue to follow the EU’s lead.
Under the terms of various pieces of UK legislation enacted since the UK decided to leave the EU, what was previously EU Single Market legislation has been adopted as UK domestic product safety legislation. Until new legislation is brought forward and adopted from within the UK, the rules for product safety precisely mirror (give or take some terminology changes and the UKCA Mark to replace the CE logo) what was in force in the EU Single Market on 31st December 2020.
The UK now has ‘third country’ status, which means that manufacturers and importers based in GB and selling into the EU are no longer within the European Community and will need to identify an importer or appoint an Authorised Representative who is within the EU if they wish to trade across the border. Similarly, EU based manufacturers wishing to sell in GB will now need to have representation in the UK.
New Legislative Framework
The legislation which drives the requirement for representation in the EU is 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):
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.)
These directives/regulations have all been enacted in UK legislation. This page cross-references the various pieces of legislation.
Requirement to identify the importer
The NLF identifies manufacturers, importers, authorised representatives and distributors as ‘economic operators’ and defines the responsibilities of each. Among the responsibilities for the importer is that they should be identified with their name and address on the product, its instructions for use (IFU) or its packaging.
This requirement has actually been in place since 2016 but it has been widely ignored in the UK until now. Customs changes brought about by Brexit and a new set of rules on VAT which came into force at the same time as the UK finally left the EU at the end of 2020 have brought a new focus onto the requirement to identify an ‘economic operator’ based within the UK who can act as a contact point for the UK Market Surveillance Authorities (UK-MSA).
UK guidance states:
You’re an importer if you’re the first one bringing goods from outside the UK and placing them on the market in Great Britain. If someone has already placed a good on the UK market before you sell it in Great Britain then you will remain a distributor and will not have any additional responsibilities.
As an importer, you’ll need to make sure that:
- goods are labelled with your company’s details, including your company’s name and a contact address. Until 31 December 2022 you can provide these details on the accompanying documentation rather than on the good itself if you import certain goods from the EEA (and in some cases Switzerland). After 31 December 2022, your details must be affixed to the product or, in circumstances where the legislation allows, on the packaging or an accompanying document
- the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
- the manufacturer has drawn up the correct technical documentation and complied with their labelling requirements
- you maintain a copy of the declaration of conformity for a period of 10 years
- goods conform with the relevant essential requirements
You must comply with the above for goods placed on the GB market regardless of whether they are CE or UKCA marked.
Interestingly, this page used to read:
You’re an importer if you’re the first one bringing goods from outside the UK and placing them on the market in Great Britain. If someone has already placed a good on the UK market before you sell it in Great Britain - or if the manufacturer has appointed another UK-based person to carry out importer duties - you will remain a distributor and will not have any additional responsibilities.
This wording was changed to remove the words in bold in January or February 2022, presumably because although these words are helpful to understand the relationship between an importer and an Authorised Representative, they are not actually based on words in any of the legislation. Thus, while in most cases it would make sense for the Authorised Representative to be identified on the product instead of the importer, the law (in the UK at least) requires that it is the importer who is the identified, not the Authorised Representative.
The EU Market Surveillance Regulation 2019/1020 (see below) addresses this point and allows any one of 4 different types of 'economic operatoir' to be identified on the goods as the responsible party, but the Regulation has not been implemented in the UK so the requirements for the UK remain those which are in the NLF.
Location of the importer
The definition of ‘importer’ within the NLF reads as follows (Decision No 768/2008/EC Article R1 item 5):
‘importer’ shall mean any natural or legal person established within the Community who places a product from a third country on the Community market;"
UK legislation reads (for example from the Low Voltage Electrical Equipment (Safety) Regulations 2016, Regulation 2(1)):
“importer” means any person who—
(a) is established within the EU; and(b) places electrical equipment from a third country on the EU market;
(a) is established in the United Kingdom, and(b) places electrical equipment from a country outside of the United Kingdom on the market;
General Product Safety Regulations
Based on the EU’s General Product Safety Directive, the UK’s General Product Safety Regulations 2005 (GPSR) are a catch-all requirement which is intended to regulate the safety of consumer products not covered by more specific legislation.
The GPSR do not require CE marking or UKCA marking for products within their scope.
Products within the scope of the GPSR must have a ‘producer’ who takes responsibility for placing the product on the market. A producer can be a manufacturer based within the UK, a ‘manufacturer’s representative’ based within the UK if the manufacturer is based outside, or an importer into the UK.
Regulation 7(4) of the GPSR requires the producer to provide their name and address on or accompanying the product. Thus, even for products which do not require the CE or UKCA mark, there must be an identified representative of the manufacturer based within the UK.
The Supply of Machinery (Safety) Regulations 2008
The Supply of Machinery (Safety) Regulations 2008 (SMSR) transposes the EU Machinery Directive 2006/42/EC into UK law. The Machinery Directive has not been updated in line with the NLF and so it (and SMSR) do not contain a requirement for the importer to be identified on the product.
Part 2 item 1 of SMSR Annex II deals with the content of the manufacturer's declaration of conformity. Before it was amended by the Brexit legislation it stated that the manufacturer must identify on their declaration “the name and address of the person authorised to compile the technical file, who must be established within the EEA”. However, the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 amended this clause by removing the words “who must be established within the EEA”. Therefore, at present, there is no restriction on where in the world the ‘person authorised to compile the technical file’ for a UKCA marked machine can be located.
It should, however, be noted that it is fairly unusual for machinery not to have electrical and other equipment which potentially also brings it within scope of the EMC, RoHS and other regulations which do require the importer (or an AR) to be identified.
The EU Market Surveillance Regulation
Regulation 2019/1020, better known as the Market Surveillance Regulation (MSR), is a measure which was enacted by the European Union to clarify the relationships between the different economic operators and bring consistency across the different EU directives and regulations. The Regulation came into force in the EU on 16 July 2021.
Because the implementation date of the Regulation is after the end of 2020, the UK is not bound to apply the MSR in GB, and the UK government has announced that it does not intend to do so voluntarily. This leaves the legal status of AR’s and importers in the UK a little less certain than will be the case within the EU.
Direct shipment to end users
To summarise the above discussion, when shipping product into GB (unless shipping direct to end users), a UK based importer must be identified, even if the manufacturer has appointed a UK-based AR. This requirement is a consequence of Brexit and in effect has been in place since 1 January 2021, although it originates from legislation originally introduced in 2016.
In practice, our experience is that the MSA are not usually terribly worried about whether it is the AR's or the importer's address on the product, so long as any address which is present provides them with a prompt response to their enquiries. If the manufacturer is keeping adequate records, and these are available to the AR when required, the AR will always be able to identify who is the importer for any specific unit, so the objective of the legislation is acheived even if adherence to the precise wording is not.
Advantages of appointing a UK Authorised Representative
Most manufacturers will probably want to appoint an AR rather than rely on their importer, for several reasons:
- they may not want their importer to see all their technical documentation in the event of a UK-MSA action;
- their importer(s) may be reluctant to be put in a position where they have to deal with a UK-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. If an AR is appointed then theirs is the only address required;
- Importers will generally be much happier to trade with a 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.