Responsible Person requirement for CE-marked products

What is coming?

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 CE-marked products to have someone present in the European Union acting as the point of contact for product compliance (a “Responsible Person”). All CE marked products are covered by this rule except for medical devices, explosives for civil uses, and certain lifts and cableway installations.

This page outlines what is changing and offers some guidance on what you can do to prepare for the changes. 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.

What does this mean for me?

If you sell CE-marked products that are manufactured outside of the EU, you will need to ensure that such products have a Responsible Person in the EU prior to July 16, 2021. After July 16, 2021, it will be illegal to sell CE-marked products in the EU without an EU Responsible Person. All CE marked products are covered by this rule except for medical devices, explosives for civil uses, and certain lifts and cableway installations.

Prior to July 16, 2021, you will need to ensure that your CE-marked products are labelled with the contact information of the Responsible Person. This labelling can be done on the product, its packaging, the parcel, or an accompanying document.

How will I know if I need an EU Responsible Person?

The first step is to confirm that your products are subject to CE-marking legislation. 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.

We also have some additional guidance for CE-marking legislation here. If you are unsure if the products you sell are required to be CE-marked, we recommend that you reach out to your supplier/legal counsel to investigate further.

I am the brand owner of CE-marked products; what should I do next?

If you are the brand owner of CE-marked products (other than medical devices, explosives for civil uses, and certain lifts and cableway installations), we recommend that you take the following steps:

1. Verify compliance of your products: Ensure that your products satisfy all the relevant CE marking requirements (more information can be found here) and that the corresponding documents (e.g.Test reports and Declaration of Conformity) have been drawn up. You will need to provide the Declaration of Conformity (or Declaration of Performance) to your Responsible Person and be able to provide other technical documentation on request.
2. Enrol in Amazon Brand Registry: We encourage you to register your brand in Amazon Brand Registry to take advantage of the tools we offer to brand owners. For more information about Amazon Brand Registry, including a list of frequently asked questions, visit our Brand Registry information page .
3. Appoint an EU Responsible Person for your products: A brand owner has flexibility in who they can appoint as the Responsible Person. Some options you should consider:
   
   1. If you have a subsidiary in the EU or already have an EU importer, it may be possible to appoint them as the Responsible Person for your products.
   2. The testing laboratory or the certification company that you use for your products may be offering Responsible Person services.
   3. You may want to take advantage of the third-party providers offered in Amazon’s Service Provider Network. Visit this help page to learn more about these options.

Amazon offers a Responsible Person Service for FBA products, which could make sense for you if you sell your products through Amazon’s FBA service. For details on eligibility, pricing and terms and conditions, please visit this page.

I already have a Responsible Person for my brand/ASINs; do I need to let Amazon know?

Yes. Amazon collects contact information of the Responsible Person for non-EU brands/ASINs using Amazon’s FBA service. Amazon has enabled a dashboard in Seller Central to allow you to declare your EU Responsible Person for your brand/ASINs. Currently, access to the dashboard is restricted to brand representatives/authorized resellers in the Toys and Electrical/Electronics categories, but further categories will enabled in the coming months.

I don’t own a brand but I still sell CE-marked products; am I still impacted?

Yes. If you are a reseller of CE-marked products, we recommend talking with your upstream suppliers to confirm they are aware of the upcoming changes and to ensure they are taking appropriate actions to appoint a Responsible Person. You can also confirm with your manufacturer/supplier if options a. and b. from the list above may be applicable to them.

Other frequently asked questions

Who can be an EU Responsible Person?

An EU Responsible Person can be one of the following:

• The manufacturer or brand, if established in the EU.
• An importer established in the EU.
• An authorised representative established in the EU, who is appointed in writing as the Responsible Person by the manufacturer or brand.
• A fulfilment service provider established in the EU.

What does the Responsible Person have to do?

The Responsible Person is required to do the following:

1. Collect the product’s EU Declaration of Conformity (or Declaration of Performance) and ensure that additional documents demonstrating EU conformity of the product can be made available from the manufacturer or brand owner upon request in a language understood by an authority;
2. In some cases, inform authorities of any risk posed by the product; and
3. Cooperate with market surveillance authorities, including ensuring that the manufacturer or brand owner takes necessary corrective actions to remedy any non-compliance of the product.

In addition, the contact information of the Responsible Person is required to be displayed on the product or on its packaging, the parcel, or an accompanying document.

Can Amazon act as the Responsible Person on my behalf?

Yes, Amazon offers a Responsible Person Service for non-EU manufacturers, brand owners, and authorized resellers (with a brand mandate to sell in the EU) using Fulfilment by Amazon. For details on eligibility, pricing and terms and conditions, please visit this page.

Where can I get more detailed information on the Market Surveillance and Compliance of Products Regulation?

The EU Regulation 2019/1020 on Market Surveillance and Compliance of Products, published on June 20, 2019, sets out a framework aimed at increasing accountability for product safety and technical compliance, as well as enforcement of technical compliance breaches.

We strongly encourage you to visit the European Commission’s website for more information on EU Regulation 2019/1020 on Market Surveillance and Compliance of Products:

• https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM%3A2017%3A787%3AFIN
• https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1020&from=EN