Legal framework for Authorised Representatives in the UK

Due to increasing globalization and the free movement of goods, there is growing concern and importance being given to market surveillance and product safety by the authorities in the European Union and the United Kingdom, as well as in other parts of the world.

In a drive towards achieving more control over the products that are placed on the market, the European Union implemented new legistlation and obligations for manufacturers, importers and distributors, aslo know as economic operators. Following Brexit, on the 1st January 2021 the United Kingdom implemented the same legistlation into UK law.

Manufacturers and importers need to be aware of these changes to their obligations.

Brexit

The UK is no longer part of the EU and has ‘third country’ status. This means that manufacturers and importers based in the EU and selling into the UK are not considered to be within the United Kingdom and therefore, need to identify an importer or appoint an Authorised Representative who is within the UK if they wish to trade in the UK. The same rule applies to UK manufacturers that sell in the EU who must now have representation in the EU.

What is the legislation guiding this principal?

The following legislation was implemented into UK law on the 1st January 2021.

Regulation (EC) No 765/2008 of the European Parliament and of the Council, also known as the New Legislative Framework, or NFL

https://www.legislation.gov.uk/eur/2008/765

The regulation 765/2008 is complementary to 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.

https://www.legislation.gov.uk/eudn/2008/768/contents

Finally, the Regulation EU 2019/1020 on market surveillance and compliance of products helps clarify some questions not made clear in the Regulations 765 and 768 mentioned above. Specifically that any of the economic operators may be identified on the product as the contact for the MSA's. For example, if mandated by the manufacturer, an authorised representative established in the community, i.e. the UK, can be shown on the product as the contact for the MSA.

https://www.legislation.gov.uk/eur/2019/1020

In brief, these regulations set out the requirements for accreditation and market surveillance relating to the marketing of products and the obligations of the economic operators.

Requirement to identify the importer´s details, or those of the economic operator

In the legislation the obliglations of all the economic operators our outlined. Included in the obligations of the importers is the requirement to identify their name and address on the product. Where this is not possible, or impractical the information can be shown on the packaging or the paperwork that accompanies the product to the end user.

The reason behind this is so that the Market Surveillance Authorities (aka the MSA´s) have easily accessible information that they can use if they wish to make an enquiry or pursue an action regarding a particular product.

The details shown on the product, packaging or documentation must be those of an importer that is established within the community (EU 2008/768 article R1, point 5).

With regards to the EU, the community refers to any country with the EU, and with regards to the UK, the importer must be established within the United Kingdom and easily accessible for the UK-MSA's to contact if required.

Regulation 2019/1020 states;

..contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document. (Regulation (EU) 2019/1020, chapter II, article 4, paragraph 4.)

Summary

LF summary

To summarise the above information, manufacturers that are not based in the UK that ship products to the United Kingdom must choose who they wish to work with as their representative and contact for the Market Surveillance Authorities.

The representative they choose to work with must comply with the following obligations, outlined in the Regulations indicated above, as well as any other obligations they may have specific to their role as an economic operator.

Obligations:

Ensure the manufacturer has carried out the appropriate conformity assessment process and drawn up the relevant technical documentation.

Keep a copy of the technical documentation and declaration of conformity at the disposal of market surveillance authorities for the period required by that legislation and ensure that the technical documentation can be made available for the authorities on request.

If requested by a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the product in a language easily understood by the authority.

In the event a risk is identified, inform and cooperate with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance with the requirements set out in the legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.

Ensure that the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

What are the advantages of appointing an Authorised Representative?

As discussed above, the contact information of the economic operator is required on the product, the packaging or documentation that accompanies the product for reasons of traceability of the product and for the market surveillance authorities (MSAs) as a point of contact in the UK in case of any enquiry or action required.

It is worth noting that the MSAs have the authority to impound goods which do not carry the required marking.

The reasons why more and more manufacturers are choosing to work with and AR, rather than with their importer, include the following:

they prefer not to involve their customer in any MSA enquiry or action and prefer them not to see the technical information that may be requested by the MSA.

the customer (importer) prefers not to have to deal with the MSA in case of an action.

the manufacturer has several customers (importers) and prefers to have just one name and address for all the products.

the AR will provide information and updates regarding the relevant product legislation.

the AR will file the technical documentation and will keep it available on request for the market surveillance authorities for the specified period.