EU Market Surveillance Regulation 2019/1020

Regulation details
The new EU product safety regulation (called the “EU Market Surveillance Regulation 2019/1020”) will take effect on 07/16/2021. The new regulation requires products bearing the CE mark to have a person in the EU as the product compliance contact person (hereinafter referred to as the “EU Responsible Person”). With the exception of medical devices, civilian explosives, and certain lift and ropeway devices, all products bearing the CE mark are covered by this regulation.
If you sell products that are CE marked and are manufactured outside of the European Union, then by July 16, 2021, you need to ensure that:
a) such products have a Responsible Person in the EU;
b) Your CE-marked products have the responsible person’s contact information attached. This label can be affixed to the product, product packaging, parcel, or accompanying document.
After July 16, 2021, it is illegal to sell CE-marked products in the EU without an EU Responsible Person.
Definition of the CE mark
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 regulations require manufacturers of CE-marked products to issue an EU Declaration of Conformity for the product and draw up technical documentation.
To view the complete list of CE-marked products/CE marking rules, click "View Details."
List of CE-marked products affected by this regulation
All CE-marked products are covered by this regulation, except medical devices, civilian explosives, and certain lifts and cableway installations. Please check whether your products are CE-marked products affected by this regulation.
To view the list of CE-marked products affected by this regulation, click "View Details."
EU Responsible Person
The EU Responsible Person can be any of the following:
● The manufacturer or brand owner (if established in the EU).
● An importer established in the European Union.
● An authorized representative established in the European Union, designated in writing by the manufacturer or brand as the responsible person.
● delivery service providers established in the European Union.
The person in charge is required to do all of the following:
● Collect the product’s EU Declaration of Conformity (or Declaration of Performance), and ensure that the manufacturer or brand owner can, as required, provide other documents demonstrating that the product complies with EU requirements in a language understood by the authorities;
● In some cases, inform the appropriate authorities of any risks that may be caused by the product;
● Cooperate with market surveillance authorities to ensure that manufacturers or brand owners take the necessary corrective measures to address any product noncompliance, etc.

Seller compliance process

If your CE-marked products sold in the EU are affected by this regulation (see the “List of CE-marked products affected by this regulation” above), we recommend that you take the following measures (consult your legal advisor if needed).
Verify that the product complies
Verify products
Compliant
Assign an EU Responsible Person
Designate the EU
Responsible Person
Upload EU Responsible Person information
Upload EU Responsible Person
Responsible Person Information
Show EU Responsible Person information
Show EU
Responsible Person Information

Amazon official compliance solution

Amazon Responsible Person service (ARP) is a convenient solution for sellers outside the EU who sell products through Fulfillment by Amazon (FBA) (brand owners or authorized brand resellers with the right to sell products in the EU). After you subscribe to this service, Amazon will act as the EU Responsible Person for your designated CE-marked products.
Benefits
Before December 31, 2021
Offer free service
Submit documents online
Complete your subscription self-service
The operation page is simple
Clear instructions

Frequently Asked Questions

What should I do if the dashboard lists ASINs that do not require CE marking, or if my CE-marked ASINs do not appear on the dashboard?
If you believe that some of the ASINs shown on the dashboard do not require the CE mark, or if you believe that some of your CE-marked ASINs do not appear on the dashboard, please contact us and provide the brand name and a list of affected ASINs.
Will Amazon remove my products if I am not compliant by July 16, 2021?
Starting June 11, 2021, if the relevant information is not entered in the dashboard, your ability to create Fulfillment by Amazon inbound shipments will be affected. In addition, Amazon will comply with any external regulatory authority’s request to remove products for which the Responsible Person cannot be identified or verified.
What should I do if my inbound shipment in transit is missing Responsible Person/Amazon Responsible Person information and may not be delivered before 07/16/2021?
Although you must update your packaging, products, and accompanying documents with the relevant information, we understand that during this transition period, some products may not be able to provide the required information before the above regulations are issued.
Before Customs or a European regulator contacts you or Amazon, be sure to designate a Responsible Person and enter all relevant Responsible Person information in the dashboard to minimize delays/issues for your products. If you use the Amazon Responsible Person service, Amazon will cooperate with the relevant regulatory authorities to resolve this issue.
What should I do if a Responsible Person has already been assigned to my ASIN?
If you find existing Responsible Person information when you view your ASIN in the dashboard, and you can confirm that the brand/ASIN information is accurate, you do not need to take any further action.
If you believe the brand information is not correct, we recommend that you contact your manufacturer or upstream supplier to confirm the correct information.
If you want to assign a separate Responsible Person for a product, please follow the steps in the dashboard to complete the process of uploading the Responsible Person information.
I have completed all the information in the dashboard, but I just changed the Responsible Person. What should I do?
You can edit your Responsible Person information at the brand/ASIN level within the dashboard at any time.
Can the same EU Responsible Person serve in this role for multiple brands/stores?
Yes. As long as your EU Responsible Person can fulfill the specific responsibilities related to keeping documents and acting as the product compliance point of contact (POC) when needed, they can do this for multiple sellers.
The Responsible Person must do the following:
• Collect the product’s EU Declaration of Conformity (or Declaration of Performance), and ensure that the manufacturer or brand owner can provide, as required, other documents proving that the product complies with EU requirements in a language understood by the authorities;
• In some cases, inform the appropriate authorities of any risks that the product may present; and
• Work with market surveillance authorities to ensure that manufacturers or brand owners take the necessary corrective measures to address any product non-compliance, among other things.
What does Brexit mean for this regulation?
Because the UK has completed Brexit, it is not within the scope of these changes to EU product safety regulations, so:
• The Responsible Person cannot be located in the UK, and
• Products sold on Amazon.co.uk are not required to list the EU responsible person on the packaging/product.
The UK government announced that it will establish the UK Conformity Assessed marking system (UKCA for short). As of January 1, 2021, this system replaced the CE marking. In the UK (excluding Northern Ireland), products must comply with the UK regime; however, the CE mark is still valid for most products until January 1, 2022. Different rules apply in Northern Ireland.
For more details, please visit:
a) UK government website
b) WeChat article
If I use the Amazon Responsible Person service, how do I display the Amazon Responsible Person information on the product?
As of June 4, 2021, if Amazon is the Responsible Person for your Fulfillment by Amazon (FBA) products, Amazon will provide EU Responsible Person information for your packages.
• Detailed contact information for Amazon Responsible Person will appear on the Fulfillment by Amazon shipment label to prevent the shipment from being held by customs.
• You don't need to take any action on the actual item. Amazon will provide detailed contact information for the Amazon Responsible Person for all buyer packages.
Please note:
• This service applies only to Fulfillment by Amazon (FBA) products sold on Amazon’s EU sites. This service does not apply to products supplied through other channels (including other Amazon services, third-party services, or products you supply directly).
• The ARP service only covers ASINs for which you have submitted compliance documents in the dashboard. Only those ASINs will automatically generate inbound labels with the Amazon Responsible Person’s contact information when you create a shipment.