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EU and UK Product Compliance Guidance – CE and UKCA Marking

Introduction

Customer safety is Amazon’s primary priority and, as a seller, you must take care that the products you supply are not only safe but also compliant with the relevant regulations.

This page provides guidance on existing requirements for CE marked products to help you understand how to sell these products compliantly in the EU, and in the UK after December 31, 2020.This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your products.

This material only reflects the position at the date of writing and requirements in the EU and the UK may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (where available) to learn more about changes that may affect you following the end of the transition period.

I. EU Requirements

What is CE Marking?

The CE mark is a self-certification mark applied to a product by the manufacturer. The CE mark indicates that the product meets health, safety, and environmental protection standards for the European Economic Area (EEA). In addition, EU legislation requires that the manufacturer of a CE marked product issues an EU Declaration of Conformity for the product and draw up technical documentation (discussed in further detail below).

Not all products sold in the EEA are required to be CE marked. Common examples of products that are required to be CE marked include toys, electronics, personal protective equipment, machinery, construction products, gas appliances, recreational and personal watercraft, pressure vessels, and measuring equipment.

You can find a full list of the products subject to CE marking, as well information on the steps a manufacturer needs to take to affix the CE mark here:

What does CE marking legislation mean for me?

You must make sure that the products you sell meet the CE marking rules. To do so, we recommend that you do the following (with the help of your legal counsel, if needed):

  1. Confirm whether the products you sell require a CE mark.
  2. For products that require a CE mark, work with your upstream supplier to ensure that:
    • The manufacturer has affixed the CE mark and all other relevant compliance markings to the product (or, in some circumstances, the packaging or accompanying documentation); and
    • The manufacturer has issued a valid EU Declaration of Conformity (or Declaration of Performance for construction products) and drawn up additional applicable compliance documentation that you can provide upon request.
    • An EU Responsible Person has been designated for the product. This requirement comes into effect in July 16, 2021 pursuant to the new Market Surveillance Regulation (EU) 2019/1020. It applies to all CE marked products except medical devices, explosives for civil uses, and certain lifts and cableway installation. If your brand is EU based, the Responsible Person is the Brand. If your Brand is based outside of the EU, the Brand should ensure there is a Responsible Person for products sold in the EU. For more details on the Market Surveillance Regulation, the Responsible Person requirement and what you need to do, please visit this page

What is an EU Declaration of Conformity (DoC)?

A Declaration of conformity (DoC) is a document signed by a manufacturer or authorised representative confirming that the product placed in the market complies with applicable EU requirements, and is required for all CE Marked products sold in the EU with few exceptions. The contents of the Declaration of Conformity shall follow the model declarations set out in Annex III to Decision 768/2008/EC or in annexes to applicable legislation.

By the drawing up and signing of the Declaration Conformity, the manufacturer takes responsibility for product compliance with all applicable EU laws.

You should consult applicable legislation to ensure the Declaration of Conformity meets all applicable requirements.

At a minimum, the DoC must clearly include the following information:

  • Name and full business address of the manufacturer or that of their authorized representative
  • Product's serial number, model, or other unique product identification
  • Statement that the brand owner or manufacturer take full responsibility for the declaration
  • Means of identification of the product allowing traceability
  • The relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
  • Where applicable, details of the notified body (name and number) which carried out the conformity assessment procedure, and reference to issued certificates
  • Name, Signature and Position of Person signing
  • The date the declaration was issued

When requested, the DoC should be provided in a non-editable format (for example, PDF), and must be signed by a responsible employee of the manufacturer (including the employee’s printed name and position).

Further guidance on the creation of the DoC and the related requirements can be found here.

What is a Declaration of Performance (DoP)?

Construction products covered by a European harmonised standard or for which a European Technical Assessment has been issued, are required to have a Declaration of Performance (DoP) issued by the manufacturer instead of a DoC. In addition to the requirements of a DoC, the DoP must provide information about product’s essential requirements (e.g., durability, thickness, reaction to fire), the performance of the product and the harmonised technical specifications. Furthermore, the product itself has to be CE marked. For more information, you can visit this page.

What is a harmonised standard?

For some product types, the EU has created harmonized standards that manufacturers, other economic operators, or conformity assessment bodies can use to demonstrate that products comply with relevant EU legislation. For detailed information, refer to the information on this page.

Is the EU DoC/DoP the only compliance document that I need?

No. CE-marked products require additional required compliance documents (for example, test reports or certificates) to further demonstrate the compliance of the product. Depending on the product type, technical documentation should provide information on the design, manufacture, and operation of a product, and are necessary to demonstrate compliance of the product and support the DoC or DoP. You need the technical documentation before products are placed on the EU market and in order to affix the CE mark to the product. The contents of technical documentation are specified in Annex II of Decision 768/2008/EC and in applicable legislation. The technical file usually includes test reports, product certificates, technical drawings, factory certificates, quality assurance and control documentation, bill of materials, etc. The technical file should be updated periodically and must be updated if there are material product changes.

You may be required to provide these documents at short notice, so it is important to ensure that you have access to any required compliance documents for all of your CE marked products.

What is a Responsible Person?

On July 16, 2021, a new EU Regulation on product safety (called the “Market Surveillance Regulation (EU) 2019/1020”) is coming into effect. This new regulation adds the requirement for all CE-marked products (except for medical devices, cableway installations, explosives for civil uses, hot-water boilers, and lifts) to have someone present in the European Union acting as the point of contact for product compliance and to deal with certain compliance related activities (a “Responsible Person”). For more details see Responsible Person Requirement Help Page.

Does Amazon offer any support in ensuring compliance?

For a more detailed overview of Compliance regulations, we recommend you review the Product Safety and Compliance Seller Central page, which also has a more detailed overview on individual regulations.

In addition, you can find a list of external consultants who might help you with questions regarding regulatory requirements on the Compliance Solutions page in the Service Provider Network.

II. UK Requirements

What is CE Marking?

The CE mark is a self-certification mark applied to a product by the manufacturer. The CE mark indicates that the product meets health, safety, and environmental protection standards for the European Economic Area (EEA). In addition, EU legislation requires that the manufacturer of a CE marked product issues an EU Declaration of Conformity for the product and draw up technical documentation (discussed in further detail below).

Not all products sold in the EEA are required to be CE marked. Common examples of products that are required to be CE marked include toys, electronics, personal protective equipment, machinery, construction products, gas appliances, recreational and personal watercraft, pressure vessels, and measuring equipment.

You can find a full list of the products subject to CE marking, as well as information on the steps that a manufacturer needs to take to affix the CE mark, here:

What is UKCA Marking?

CE marking is required for applicable products made available in the UK or EU for the first time on or before December 31, 2020.

Products that are first made available in the EU or UK on or before December 31, 2020 can continue to circulate until they reach their end user and do not need to comply with the changes that take effect from January 1, 2021. You can retain evidence of when products were first made available in the UK or EU by keeping documents including contracts of sale, invoices and documents concerning the shipping of goods for distribution.

After December 31, 2020, most products that required a CE mark, as well as aerosols, will require the UKCA mark in order to be made available in Great Britain (England, Scotland and Wales, “GB”). The UKCA mark is a new product marking. UKCA stands for UK Conformity Assessed. You can find UK Government guidance on using the UKCA mark here: https://www.gov.uk/guidance/using-the-ukca-mark-from-1-january-2021.

Note: The UK Government has released guidance which provides that for certain products, CE marking will be accepted in the UK until January 1, 2022, and that additional means of affixing the UKCA mark will be accepted until January 1, 2023.

Please also note that different rules apply to goods you sell in (1) GB and (2) Northern Ireland.

For more information, see the UK Government Brexit guidance linked below.

What does the legislation requiring the CE or UKCA mark mean for me?

You must make sure that the products you sell meet the CE and/or UKCA marking rules. To do so, we recommend that you do the following (with the help of your legal counsel, if needed):

  1. Confirm whether the products you sell require a CE and/or UKCA mark.
  2. For products that require a CE and/or UKCA mark, work with your upstream supplier to ensure that:
    • The manufacturer has affixed the required mark and all other relevant compliance markings to the product (or, in some circumstances, the packaging or accompanying documentation); and
    • The manufacturer has issued a valid Declaration of Conformity (or Declaration of Performance for construction products) and drawn up additional applicable compliance documentation that you can provide upon request.

What is a Declaration of Conformity (DoC)?

A Declaration of conformity (DoC) is a document signed by a manufacturer or authorised representative confirming that the product placed in the market complies with applicable requirements, and is required for all CE and/or UKCA Marked products sold in the UK, with few exceptions. Products that are marked with a CE mark should have an EU Declaration of Conformity and products that are marked with a UKCA mark should have a UK Declaration of Conformity. The contents of the Declaration of Conformity shall follow the model declarations set out in annexes to applicable legislation.

By the drawing up and signing of the Declaration Conformity, the manufacturer takes responsibility for product compliance with all applicable laws.

You should consult applicable legislation to ensure the Declaration of Conformity meets all applicable requirements.

At a minimum, the DoC must clearly include the following information:

  • Name and full business address of the manufacturer or that of their authorized representative
  • Product's serial number, model, or other unique product identification
  • Statement that the brand owner or manufacturer take full responsibility for the declaration
  • Means of identification of the product allowing traceability
  • The relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
  • Where applicable, details of the notified body (name and number) which carried out the conformity assessment procedure, and reference to issued certificates
  • Name, Signature and Position of Person signing
  • The date the declaration was issued.

When requested, the DoC should be provided in a non-editable format (for example, PDF), and must be signed by a responsible employee of the manufacturer (including the employee’s printed name and position).

Further guidance on the creation of the DoC and the related requirements can be found here.

What is a Declaration of Performance (DoP)?

Construction products covered by a designated standard or for which a UK Technical Assessment has been issued, are required to have a Declaration of Performance (DoP) issued by the manufacturer, instead of a DoC. In addition to the requirements of a DoC, the DoP must provide information about product’s essential requirements (e.g., durability, thickness, reaction to fire), the performance of the product and the harmonised technical specifications.

Furthermore, the product itself has to be CE marked, from January 1, 2021, it may be UKCA marked. For more information, you can visit this page.

What is a harmonised standard?

For some product types, there are harmonised standards that manufacturers, other economic operators or conformity assessment bodies can use to demonstrate that products comply with relevant legislation.

Is the DoC/DoP the only compliance document that I need?

No. CE and/or UKCA-marked products require additional required compliance documents (for example, test reports or certificates) to further demonstrate the compliance of the product. Depending on the product type, technical documentation should provide information on the design, manufacture, and operation of a product, and are necessary to demonstrate compliance of the product and support the DoC or DoP.

You need the technical documentation before products are sold in the UK and in order to affix the CE and/or UKCA mark to the product. The contents of technical documentation are specified in the applicable legislation. The technical file usually includes test reports, product certificates, technical drawings, factory certificates, quality assurance and control documentation, bill of materials, etc. The technical file should be updated periodically and must be updated if there are material product changes.

You may be required to provide these documents at short notice, so it is important to ensure that you have access to any required compliance documents for all of your CE and/or UKCA marked products.

Does Amazon offer any support in ensuring compliance?

For a more detailed overview of Compliance regulations, we recommend you review the Product Safety and Compliance Seller Central page, which also has a more detailed overview on individual regulations.

In addition, you can find a list of external consultants who might help you with questions regarding regulatory requirements on the Compliance Solutions page in the Service Provider Network.

Northern Ireland Guidance

Please note that different rules will apply in Northern Ireland (“NI”) from January 1, 2021 as a result of the Northern Ireland Protocol. In particular:

  • You should ensure that products meet EU requirements and that you use the CE mark.
  • You are an importer if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU / NI based importer.
  • Authorised representatives can be based in NI or the EU. From July 16, 2021, new rules come into force under EU Regulation 2019/1020 and some businesses may need to appoint a responsible person in the EU or NI to carry out compliance functions (if there is no other entity in the supply chain who is able to carry out the functions). Further guidance on the new rules will be made available by the UK Government.
  • If you are using a UK body to carry out mandatory third-party conformity assessment, you will need to apply a UKNI marking as well as a CE mark to products placed in NI from January 1, 2021. Goods with the CE and UKNI marking can’t be sold in the EU. You do not need to use the UKNI marking if you self-certify compliance or use an EU body to carry out a mandatory third-party assessment.
  • “Qualifying Northern Ireland goods” will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

BREXIT: UK Government Guidance

The UK Government has released guidance on selling products in GB and NI after Brexit. This guidance provides information for manufacturers, importers and distributors regarding compliance requirements from January 1, 2021, including on:

  • whether you need to change your conformity assessment;
  • when and how to use the UKCA mark;
  • requirements for technical documentation and a specific Declaration of Conformity for products sold in GB;
  • appointing an authorised representative or responsible person in the UK;
  • whether your legal responsibilities will change as a result of Brexit;
  • whether you need to provide GB importer information, and methods for doing this (including transitional arrangements until the end of 2022);
  • how to deal with existing stock;
  • what documentary evidence is required to show that products have been placed in the UK or EU before the end of the Transition Period; and
  • specific rules for selling products in NI.

We encourage you to review this guidance (linked below), alongside any other specific UK Government guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from January 1, 2021.

The Brexit guidance can be found here:

GB:

Nl:

Additional information

We also encourage you to visit the Business Companion website, which contains further guidance on UK product compliance rules:

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