On June 20, 2019, the European Parliament and Council approved a new EU regulation EU2019/1020. This regulation mainly stipulates the requirements for CE marking, the designation and operational norms of notified bodies (NB) and market regulatory agencies. It revised Directive 2004/42/EC, as well as Directive (EC) 765/2008 and Regulation (EU) 305/2011 on regulating the entry of products into the EU market. The new regulations will be implemented on July 16, 2021.
According to the new regulations, except for medical devices, cableway devices, civilian explosives, hot water boilers, and elevators, products with the CE mark must have a European representative located within the European Union (excluding the United Kingdom) as the contact person for product compliance. Goods sold within the UK are not subject to this regulation.
At present, many sellers on European websites have received notifications from Amazon, mainly including:
If the products you sell bear the CE mark and are manufactured outside the European Union, you need to ensure that such products have a responsible person located within the European Union before July 16, 2021. After July 16, 2021, selling goods with the CE mark in the European Union but without an EU representative will become illegal.
Before July 16, 2021, you need to ensure that your products with the CE mark are labeled with the contact information of the responsible person. This type of label can be affixed to products, product packaging, packages, or accompanying documents.
In this Amazon notification document, it is not only mentioned that products with CE certification need to have corresponding product identification, but also the contact information of the EU responsible person.
CE Marking and CE Certificate
1、What common products on Amazon involve new regulations?
Firstly, you need to confirm whether the products you want to sell in the EU Economic Area require the CE mark. Different categories of CE marked goods are regulated by different directives and regulations. Here, we provide you with a list of the main products and relevant EU directives involved in this new regulation:
|
Product category |
Relevant regulatory directives (coordinated standards) |
|
|
1 |
Toys and Games |
Toy Safety Directive 2009/48/EC |
|
2 |
Electrical/Electronic Equipment |
Ecodesign and Energy Labelling Directive |
|
3 |
Drugs/Cosmetics |
Cosmetic Regulation(EC) No 1223/2009 |
|
4 |
Personal Protective Equipment |
PPE Regulation 2016/425/EU |
|
5 |
Chemicals |
REACH Regulation(EC) No 1907/2006 |
|
6 |
Other |
|
EU CE Certification Laboratory
2、Who can become the head of the European Union? What are the responsibilities included?
The following forms of entities have the qualification of "responsible persons":
1) Manufacturers, brands, or importers established in the European Union;
2.)An authorized representative (i.e. European representative) established in the European Union, designated in writing by the manufacturer or brand as the person in charge;
3)Delivery service providers established in the European Union.
The responsibilities of EU leaders include the following:
1)Collect the EU declaration of conformity for the goods and ensure that additional documents proving that the goods comply with EU standards are provided to the relevant authorities in a language understandable to them upon request;
2)Notify the relevant institutions of any potential risks that may arise from the product;
3)Take necessary corrective measures to correct non-compliance issues with the product.
3、What is the "EU authorized representative" among EU leaders?
The European Authorized Representative refers to a natural or legal person designated by a manufacturer located outside the European Economic Area (EEA), including the EU and EFTA. The natural person or legal entity may represent a manufacturer outside of EEA to fulfill specific responsibilities required by EU directives and laws for the manufacturer.
For sellers at Amazon Europe, this EU regulation was formally implemented on July 16, 2021, but during the COVID-19 epidemic, a large number of epidemic prevention materials entered the EU, forcing the EU to strengthen the supervision and inspection of related products. At present, the Amazon team has established a product compliance team to conduct strict spot checks on CE certified products. All products with missing packaging from the European market will be removed from the shelves.
CE marking
Post time: Jun-17-2024
