Economic Operators & trading with the UK
EU product legislation defines the following as economic operators:
- Authorised Representatives
Brexit will have significant impacts for economic operators trading with the UK (see Trading with Great Britain below). The implementation of the Protocol on Ireland/Northern Ireland since 1 January 2021 means that the impact on business buying and selling product in Northern Ireland is different to business trading with Great Britain (England, Scotland & Wales) (see Protocol on Ireland/Northern Ireland below).
From the end of the transition period on 31 December 2021 an economic operator (manufacturer, distributor or importer) established in the United Kingdom is no longer be considered as an economic operator established in the EU.
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 their 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. The responsibilities of a manufacturer are the same whether he is established in a Member State or outside the EU.
If an importer or distributor modifies a product or puts a product on the market under their own name or trademark, they may be considered the manufacturer and would take on the responsibilities of the manufacturer.
The importer is the economic operator established in the EU who places a product from a third country on the EU market. Before placing a product on the market, the importer must ensure:
- That the appropriate conformity assessment procedure has been carried out by the manufacturer
- That the manufacturer has drawn up the technical documentation
- Affixed the relevant conformity marking (e.g. CE marking)
- Fulfilled their traceability obligations
- Accompanied, where relevant, the product with instructions and safety information in easily understandable language
The importer must place their name and contact details on the product packaging and information leaflets.
If there is any doubt about the conformity of the product, the importer must not place it on the market or take corrective actions if the product has already been placed on the market.
A manufacturer may appoint an authorised representative in the EU to act on their behalf in carrying out certain tasks required in the applicable EU product legislation. The authorised representative must be established in the EU. 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.
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,
- Provide that authority with all the information and documentation necessary to demonstrate the conformity of a product,
- Cooperate with the competent national authorities on any action taken to eliminate the risks posed by products covered by their mandate.
The authorised representative may also 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.
Commercial representatives of the manufacturer (such as authorised distributors or agents), are not to be confused with the authorised representative which has a specific meaning in EU law.
Most EU product legislation does not require manufacturers, whether they are established in the EU or a third country, to appoint an authorised representative. However, some EU legislation does require manufacturers established outside the EU to have an authorised representative (medical devices, transportable pressure equipment or marine equipment) or a responsible person (cosmetic products) established in the EU.
Authorised representatives or responsible persons established in the UK, with certain exceptions allowed by the Protocol on Ireland/Northern Ireland, ceased to be recognised under EU legislation at the end of the transition period on 31 December 2020. Manufacturers must ensure that their authorised representatives or responsible persons are established in the EU.
The distributor is the economic operator in the supply chain, other than the manufacturer or the importer, who makes a product available on the market. A distributor acquires products for further distribution either from a manufacturer, an importer, or from another distributor.
Distributors are subject to specific obligations and have a key role to play in the context of market surveillance. They must not supply products that they know or should have assumed to be in compliance with the legislation. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures are taken by the manufacturer or the importer and inform the competent national authorities and cooperate fully with the competent authority in any actions taken.
Importing from the United Kingdom
EU product legislation still applies to all products placed on the EU market from the UK. This means that all products must meet the essential requirements set out in EU legislation, be CE marked if required by EU product legislation, certified by an EU notified body if required by EU product legislation and have a valid and up to date EU Declaration of Performance.
You can get more information on EU product legislation here.
The responsibilities of businesses importing goods from Great Britain changed on 1 January 2021. EU businesses importing products from third countries, including the UK, are defined as importers under EU law. Importers take on many of the responsibilities of non-EU manufacturers. You should:
- Find out the additional responsibilities you will be taking on
- Engage with the manufacturers of the products
- Ensure that you will be able to get the information and assurances you need
- Be able to access the technical file if required by market surveillance authorities
- Ensure your details are included in packaging and product information leaflets
Find out about the additional responsibilities you will take on as an importer here.
The UK has left the EU Customs Union which means that goods imported from Great Britain:
- Require an import declaration
- An import Safety and Security declaration
- Are subject to customs control
- May require a licence under prohibitions and restrictions rules
- May incur Value-Added Tax (VAT), Excise Duty and Customs Duties.
Irish importers are required to have an Economic Operator Registration and Identification (EORI) number, which you can register for on the Revenue Commissioners website.
There is more information on the Revenue Commissioners website.
Exporting to Great Britain
The UK has put in place a new legal framework for product certification whereby UK legislation replaced EU legislation in the UK from 1 January 2021. All products placed on the UK have to comply with UK legislation.
It applies to products placed on the Great Britain market, that is England, Scotland and Wales. The Protocol on Ireland/Northern Ireland means that it does not apply to the Northern Ireland market (see Trading with Northern Ireland above).
UK product legislation transposed EU product legislation into UK law, so many of the details are similar:
- The UKCA mark replaces the CE mark
- UK approved bodies replace EU notified bodies
- UK designated standards replace EU harmonised standards
- UK Declaration of Conformity replaces EU Declaration of Conformity
- UK customers of EU manufacturers will become importers under UK law
Irish exporters should become familiar with the UK legislation that will apply to their products. There is more information on the UK Government website.
UK Temporary recognition of CE Marking
While UK product legislation has applied since 1 January 2021, it includes a period up to the end or 2021 during which CE marked products can still be placed on the Great Britain market.
They must have a valid EU Declaration of Conformity, be certified by an EU notified body to EU harmonised standards where required by EU law.
There is a longer period of 2.5 years for medical devices which means CE marked medical devices will be accepted in Great Britain up to 30 June 2023.
Once the UK transition period ends CE marked products will no longer be accepted for the Great Britain market.
There is more information on the UK transition period on the UK Government website.
The UK has left the EU Customs Union which means that is treated the same as other third countries. Goods exported to Great Britain require an export declaration (including a Safety and Security declaration), are subject to customs control and may require a licence under prohibitions and restrictions rules.
Irish exporters are required to have an Economic Operator Registration and Identification (EORI) number, which you can register for on the Revenue Commissioners website.
There is more information on the Revenue Commissioners website.
The Protocol on Ireland/Northern Ireland came into effect at the end of the transition period on 31 December 2020. It means there is no hard border on the island of Ireland and Ireland’s place in the EU Single Market and Customs Union is protected.
Under the Protocol EU product legislation continues to apply in Northern Ireland. Northern Ireland is treated as if it is part of the EU Single Market and Customs Union.
It means that goods moving to and from Northern Ireland continue to do so with no significant changes and the responsibilities of economic operators in the EU are generally the same as if they are trading within the EU Single Market.
You can find the text of the Protocol here.
Buying products in Northern Ireland
Current EU rules generally continue to apply to products manufactured in Northern Ireland or placed on the Northern Ireland market.
- They need to be CE marked.
- Which means that they still have to be certified by an EU notified body where required by the EU product legislation.
- And they have to have an EU Declaration of Performance.
However, be aware that products marked with the CE UK(NI) mark cannot be placed on the EU market, so cannot be sold in Ireland.
As EU product legislation continues to apply in Northern Ireland, any EU business buying from a Northern Ireland manufacturer or distributor are distributors under EU law and have no additional responsibilities.
Selling products to Northern Ireland customers
The Protocol facilitates the free movement of goods, including manufactured products, on the island of Ireland. As a result:
- EU product certification
- CE marking
- EU Declaration of Performance
remains valid in Northern Ireland. This means that Northern Ireland customers of EU businesses are still distributors under EU law as it applies in Northern Ireland.
EU Blue Guide
The Blue Guide is a comprehensive guide to the operation of the EU single market for manufactured products. It is available on the EU Commission website.