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Amazon Europe Product Sales CE Latest Requirements - 20201016

2020-10-16

     

After July 2021, for products sold within the EU, in addition to the CE certification mark, there must also be an EU representative for them to be considered compliant. Before this regulation, usually when there were buyer complaints, product safety audits, category reviews, etc., Amazon would require the presence of a DOC and the packaging would need to include information about the EU representative, etc. However, with this policy, for products with the CE mark, the EU representative information must be included on the packaging. 

What is the CE mark? 

The CE mark is a self-certification mark applied by manufacturers to their products. Products with the CE mark indicate that they comply with the health, safety and environmental protection standards of the European Economic Area (EEA). Generally, the CE label can be printed on the product itself, its packaging or other accompanying documents (such as: instructions). Moreover, EU legislation requires manufacturers to issue corresponding EU conformity declarations (DoC) for all products with the CE mark.


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Although the CE mark covers a wide range, not all goods sold in the European Economic Area need to bear the CE mark. Products within the scope of the CE mark include electrical appliances, toys, personal protective equipment, medical devices, etc. 

The new EU product safety regulations - the "Market Surveillance Regulation (EU) 2019/1020" stipulates that all products bearing the CE mark must have an EU agent located within the EU territory (excluding the United Kingdom) as the contact person for product compliance (referred to as the "responsible party"). Except for medical devices, ropeway equipment, civilian explosives, hot water boilers, and elevators, all products with the CE mark are subject to this regulation. Products sold within the United Kingdom are not subject to this regulation. 

If the goods being sold bear the CE mark and are manufactured outside the European Union, then you must ensure that such goods have a responsible person located within the European Union (excluding the United Kingdom) by July 16, 2021. Otherwise, after July 16, 2021, if you sell goods with the CE mark without having the correct contact information for the responsible person, this action will be regarded as an illegal act. 

Warm reminder! Dear European sellers, before July 16, 2021, you must ensure that your products with the CE mark carry the contact information of the responsible party. Such labels can be affixed to the product itself, the product packaging, the package, or the accompanying documents (such as the manual). 

01. How to determine whether it is necessary to comply with the new regulations for CE-marked products? 

First, you need to confirm whether the goods you intend to sell in the EU Economic Area require a CE mark. 

Products with the CE mark of different categories are subject to different regulations and rules for control. 

The main goods and related EU directives covered by this new regulation:


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02. Who can be the compliance contact person for goods within the EU? 

The following forms of the subject have the qualification of "responsible person": 

o Manufacturers or brands located within the European Union 

o Importers within the European Union 

o The authorized representative within the European Union 

o Distribution service providers within the European Union 

The person in question cannot be located within the UK. 

03. What are the responsibilities of the person in charge within the European Union? 

As your compliance guarantor for goods within the European Union, the main responsibilities are as follows: 

1). Collect the EU conformity declarations of the goods and ensure that when requested by the relevant EU authorities, you can provide additional documents that prove the goods comply with EU standards in a language that the authorities can understand. The relevant documents include: EU conformity declarations (DoC), technical documents (such as third-party test reports, safety certification certificates, etc.). The EU Declaration of Conformity (DoC) refers to: a written statement issued by the manufacturer for CE Marking products, mainly used to prove that the product complies with the EU requirements for such products. 

2). Inform the relevant authorities of any potential risks associated with the product. 

3). Take necessary corrective measures to address any non-compliance issues with the products. 

04. How is the brand of CE-marked products designated as the "responsible party"? 

At present, all brand owners in the European regions are requested to complete the Amazon brand registration as soon as possible. Because the Amazon brand registration is the first step for brand product declaration to comply with the EU compliance officer. After completing this operation, Amazon will communicate with you as soon as possible to inform you how to declare the EU compliance officer for the brand/ASIN. 

Once you have a compliance officer, you can directly provide the relevant documents (test reports and conformity declarations) that prove the compliance of the goods to your EU representative. 

05. How do the distributors of CE-marked products appoint a "responsible person"? 

If you are not a brand but a distributor of products with the CE mark, it is recommended that you communicate with the upstream suppliers. 

First, inquire whether they have subsidiaries in the EU or already have EU importers. 

2). If not, you need to confirm whether they are aware of the upcoming new product safety regulations and ensure that they take appropriate actions by appointing a compliant EU-based person in charge. 

3). You can also seek assistance from product testing laboratories or companies that conduct safety certifications for the product, and ask them if they can provide the responsible person service. 

In order to better assist the sellers of Amazon Europe Station in appointing "responsible persons" and achieving compliance, Amazon will also contact the sellers shortly and provide them with more service options for EU responsible persons. 

06. What are the common CE products of Amazon? 

First, you need to confirm whether the goods you intend to sell in the EU Economic Area require a CE mark. 

Products with the CE mark of different categories are subject to different regulations and rules for control. 

The main goods and related EU directives covered by this new regulation:


Electrical/electronic equipment 

2. Toys 

3. Pressure equipment 

4. Personal Protective Equipment 

5. Pharmaceuticals / Cosmetics 

7. Where can I find more resources and relevant information?