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Amazon now requires sellers to appoint an EU Responsible Person for CE-marked products

Recently, Amazon has announced big changes that will affect sellers that sell into the European Union (EU). Sellers that are selling to the EU, but who are not located there need to appoint a representative located in the EU that will be handling all communication related to product conformity. Amazon also calls this the ‘EU Responsible Person’ or ‘Responsible Person for CE-marked products’.

The role of this ‘EU Responsible Person’ or ‘Responsible Person for CE-marked Products’ is to retain the products’ technical compliance documentation and to communicate with the market surveillance authorities on the seller’s behalf. With this requirement, Amazon is following new EU rules that will enter into force on the 16th of July 2021.

Are you a seller on Amazon and need a Responsible Person for CE-marked products? Don’t have an European Union office or subsidiary? Don’t know how to fulfill this requirement from Amazon? Do you want to (keep) access to the European market? Let us help!

Appoint Alura Group as your EU Representative Person. We are a consulting company with headquarters in Europe (Netherlands). We have more than 25 years experience in EU product conformity and CE marking. Our company represents hundreds of exporters, brand owners and Amazon sellers. We will be delighted to serve you as well.

Our services include the review and verification of test reports, certificates and other supplier product compliance documentation. Unlock Amazon’s profitable European platform and rest assure that your regulatory obligations are fulfilled, your product compliance files are complete, and your product liability is minimized.

Image of man on a laptop visiting the Amazon Seller website.
Our ‘EU Responsible Person for CE-marked products’-service allows non EU based sellers to unlock Amazon’s European platforms.

Frequently asked questions

What is a ‘Responsible Person for CE-marked Products’?

The Responsible Person for CE-marked Products or EU Responsible Person is a natural or legal person that is appointed to communicate with the market surveillance authorities of the EU Member States in which CE marked products are sold. The Responsible Person‘s role is primarily to be a single point of contact for the authorities, and to communicate on your behalf about questions related to regulatory conformity and CE compliance. For that reason, you are best served with a person that is an expert on CE marking and the CE marking regulations, standards and approval procedures.

Why is Amazon requiring a ‘Responsible Person for CE-marked Products’?

In 2020, the European Union institutions have adopted a Regulation (Regulation 2019/1020) that intends to strengthen market surveillance in the European Union. The Regulation prohibits sales from outside the European Union directly to end-users in the EU Member States. Such sales is only allowed if the exporter has a subsidiary office in the EU, works through importers, has an authorised representative or ‘Responsible Person for CE-marked products’ or ‘EU Responsible Person’.
Although the requirement enters into force in July of 2021, Amazon is already urging their sellers that are not located in the EU, but sell into the EU, to appoint an EU Responsible Person.

Is the ‘Responsible Person for CE-marked Products’ a kind of sales agent?

No. The EU Responsible Person’s role is only to operate as a single point of contact for regulatory inquiries. It is not intended to take over communication regarding sales inquiries.

Does appointing an EU Responsible Person relieve me of my liability in Europe?

No, you will remain liability for injuries and damage caused by a defect in the products you sell in the EU. The Responsible Person is your single point of contact for the authorities.

What is important when choosing an EU Responsible Person?

Remember that your market access and liability are at stake. The EU Responsible Person will represent your company towards the European market surveillance authorities. You do not want to appoint just any person that disappears at the moment there are issues. You want a knowledgeable and experienced partner that will communicate professionally with authorities. A partner that answers questions, advises you and resolves issues efficiently. You do not want incorrect statements by your ‘Responsible Person for CE-marked products’ leading to blocked sales, or even recalls.

Does the ‘Responsible Person for CE-marked Products’ have to indicated on the product label and on the Declaration of Conformity?

The requirement to appoint a Responsible Person for CE-marked Products is a requirement from Amazon if you want to sell CE marked products through their platform. It is not a legal requirements for CE marking. The CE marking regulations require the label to show the name and address of the manufacturer and importer if that is relevant.
Some EU regulations (e.g. for medical devices)require manufacturers located outside of the EU to appoint an authorised representative. The authorised representative can also be listed with Amazon as the Responsible Person for CE-marked Products. If you need an authorised representative, Alura Group can also assist you. Contact us for the details.

How can we help you to meet the Amazon ‘Responsible Person for CE-marked Products’-requirement?

Alura Group offers a dedicated service for Amazon sellers that require ‘Responsible Person for CE-marked Products’. Our company has more than 25 years experience offering regulatory representation services. Our experts have deep knowledge about the European directives, regulations, standards and procedures for a great variety of products. We have longstanding working experience with market surveillance authorities. We will handle any inquiry from the authorities professionally and accurately.
We offer our customers an electronic platform to efficiently maintain product conformity files efficiently. We also keep you informed about regulatory updates that are important for your products, so that the continued CE compliance will be ensured.

What are the legal obligations of the Responsible Person?

The Responsible Person is required to do the following:
– 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;
– In some cases, inform authorities of any risk posed by the product; and
– 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.

What we do

We act as your EU Responsible Person

Appoint us as your EU Responsible Person. Without an EU Responsible Person sellers cannot use Amazon’s European platforms. Benefit also from our on-line tools and longstanding product compliance experience.

Verify Compliance Documentation

Our experts verify the compliance documentation your suppliers give you to ensure it is complete and not false, so you do not have to worry about liabilities. We’ll also help you to draw up your Declaration of Conformity.

Communicate with EU market surveillance authorities

We are your point of contact for the market surveillance authorities and customs product compliance related questions. All regulatory inquiries will be handled by our experts professionally, and you will be always in the loop.

Our Team

Han Zuyderwijk

Founder of Alura Group. Lawyer and Senior Regulatory Consultant with over 25 years of experience in product safety and conformity and CE marking.

Olga Agafonova

Lawyer. Legal expert in product safety legislation and research associate.

Ivo Vaessen

Global business development coordinator.

Faiyaz Mohammad

Business development for India. Research associate.

Pricing

EU Responsible Person

Starting at €30 / mo *

Appoint us and sell on Amazon’s European platform

Unlimited access to our product conformity management platform

Unlimited access to our on-line trainings

24/7 online support

* Billed annually

Verification

Starting at €99

Product Documentation Review and Gap Analysis

Verification of third party certificates

Verification of third party test reports

Verification of suppliers

Assistance with Declaration of Conformity

Consulting

Ask a quote

Product conformity assessments

Risk assessment

Building your Technical Files

Quality assurance of production

Determine applicable regulations and standards

Testimonials

As most startups experience the process can be filled with many obstacles. Finding trustworthy partners is a challenge. Han and his team can be trusted to help you. I took a gamble with them and was not disappointed.

– Joseph Lawrence

Let me tell you that I am very glad to have found your site and resorted to your services.
You have saved me from a lot of potential worries with this careless manufacturer!

– Silvia Belliard

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