Placing Manufactured Goods on the EU Market from 1st January 2021

Last Updated on 02/09/2020 by Millie York

What you need to do to comply with regulations on manufactured goods you place on the market from 1 January 2021.

This guidance is about placing manufactured goods on the EU market.

There’s different guidance if you’re:

• placing manufactured goods on the market in Great Britain
• placing manufactured goods on the market in Northern Ireland from Great Britain
• placing manufactured goods on the market in Northern Ireland from the EU

If you’ve already placed your goods on the market in an EU country (or in the UK) before 1 January 2021, you do not need to do anything.

Check which rules apply

What you will need to do from 1 January 2021 depends on the type of goods you’re placing on the market.

Most of this page covers goods known in the EU as new approach goods, which can use the CE marking.

There are different rules for:

• goods regulated under the old approach (such as chemicals, medicines and vehicles)
• non-harmonised goods covered by national legislation

Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

Old approach goods

You must follow special rules if you’re placing these goods on the EU market.

Check the European Commission’s website for the latest information.

Non-harmonised goods

You must make sure that your goods meet the requirements of the first EU or EEA country in which you are placing them on the market.

Check the national regulations of the relevant EU/EEA country to find out what you need to do.

Check if you need to change your conformity assessment

You will not need to change your conformity assessment for exports to the EU if:

• you self-declare the conformity of your good against the regulations
• any mandatory third-party conformity assessment was carried out by an EU-recognised notified body (whether based in the EU or in a country with which the EU has a mutual recognition agreement)
• the certificate of conformity previously held by a UK body has been transferred to an EU-recognised notified body
• you voluntarily use a testing body (including UK bodies) to test against European or international standards

Find out how to use the CE marking.

UK conformity assessment

From 1 January 2021 any mandatory conformity assessment will need to be carried out by an EU-recognised conformity assessment body. This includes both EU based bodies and bodies in countries with which the EU has concluded a mutual recognition agreement.

UK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products being placed on the EU market unless agreed in negotiations.

Speak to your testing body or solicitor for advice on how conformity processes for your good will be affected from 1 January 2021.

Appoint an EU-recognised notified body

Check whether your UK notified body is taking steps of its own, so that you can continue to export to the EU without needing to find a new EU notified body yourself.

If not, you will need to either:

• get your products reassessed by an EU notified body
• arrange for information held by your existing notified body to be transferred to an EU notified body so they can issue you a new certificate

Certificates and documentation

If you transfer your existing certificate to an EU notified body then you will need to update the 4-digit notified body number on your products. You will not need to do this for products already on the market or which were manufactured before the transfer took place.

You will eventually need separate certificates for the UK and EU. You should speak to both your existing and new body to make arrangements that mean you will be covered for both markets in the future. If you transfer your certificate to the EU without doing this you may not be able to continue selling your goods in the UK from 1 January 2022 without having your product reassessed. This process may take a long time so you should start now.

EU and UK notified bodies are required to share information when requested by a certificate holder. This will help facilitate the issuing of new certificates of conformity where needed.

Appoint an authorised or responsible person

Authorised representatives and responsible persons based in Great Britain will no longer be recognised by the EU from 1 January 2021.

If you’re required to, you will need to appoint an authorised representative or responsible person based in the EU, EEA or Northern Ireland.

From 16 July 2021 you will need to appoint an authorised representative based in the EU or EEA if you sell goods without using an importer or fulfilment service provider. For example if you sell online and ship directly to the end user.

Check whether your legal responsibilities are changing

Manufacturers

Your legal obligations will remain largely unchanged from 1 January 2021.

EU-based distributors

If you have an EU based distributor they will become an ‘importer’ from 1 January 2021.

They will need to make sure:

• goods are labelled with their address and either your details or your EU, EEA or Norther Ireland-based authorised representative’s details (including your company’s name and a contact address or registered trademark)
• the correct conformity assessment procedures have been carried out and that goods have the correct conformity markings
• you, as the manufacturer, have drawn up the correct technical documentation and complied with the labelling requirements
• they maintain a copy of the declaration of conformity for a period of 10 years
• goods conform with the relevant essential requirements

EU-based fulfilment service providers

From 16 July 2021, if you use an EU-based fulfilment service provider, they will need to request certain compliance information from you, and goods will need to be labelled with their details.

They may ask that you appoint an authorised representative who can fulfil these obligations instead.

More information

This guidance is based on information published by the European Commission. For the latest updates on the EU’s requirements please consult the European Commission’s website.

Publised: 1st September 2020

Source: GOV UK, Department for Business, Energy & Industrial Strategy

Page URL: https://www.gov.uk/guidance/placing-manufactured-goods-on-the-eu-market-from-1-january-2021?utm_source=e3ecaa9a-e445-40ca-bf8e-624cbd7c4042&utm_medium=email&utm_campaign=govuk-notifications&utm_content=immediate