According to Regulation (EU) 2019/1020, e-commerce and other companies located outside the EU and offering goods to EU consumers must appoint a European authorised representative. Otherwise, they need to suspend their business activities within the EU. This Regulation stipulates all the rules and procedures for economic operators regarding products subject to specific EU harmonisation legislation. This Regulation also covers Fulfilment Service Providers, such as Amazon. Thus, whenever a company sells a product on the EU Amazon, Amazon will be responsible for verifying and maintaining the product’s CE compliance unless an authorised representative is appointed.
In this article, you’ll find everything you need to know about European authorised representatives (EAR), what they do and when you need one.
#1. What is a European authorised representative?
A European authorised representative (EAR) is any natural or legal person who is established within the European Union and has received a written mandate from a non-EU manufacturer to act on their behalf in relation to specific tasks concerning the manufacturer’s obligations under a relevant EU legislation. The EAR acts as a liaison between the non-EU producer and the competent national market surveillance authorities.
#2. Who needs a European authorised representative?
According to Regulation (EU) 2019/1020, companies without any actual presence or an address anywhere in the EU and selling products to EU consumers must have a European authorised representative. When there is an EAR agreement signed between an authorised representative and a manufacturer, the manufacturer can, and must, use the legal name and address of the AR on the product’s packaging.
#3. How to become an authorised representative?
To become an authorised representative of a non-EU company, you need to fulfil the following obligations:
- You must be established in the European Union.
- You must have a written mandate from a non-European producer.
- And you must accept to be the legal representative of that manufacturer.
However, when accepting the role of an authorised representative, keep in mind that if the manufacturer acts fraudulently, you may be judged responsible unless you alert the competent market authorities. Also, you must have a Regulatory Compliance person working for you who is familiar with the EU legislation and the EAR’s duties.
#4. What are the roles and responsibilities of an EU authorised representative?
The authorised representative must perform the tasks specified in the written mandate received from the manufacturer. Generally, the EU authorised representative has to do at least the following tasks in relation to a specific product:
- Keep the product’s technical documentation, including the declaration of conformity (DoC), at the disposal of the national market authorities for ten years (in some cases, five years) after the product has been placed on the market.
- Cooperate with the market regulatory authorities on preventive/corrective actions to eliminate all risks posed by the product
- Provide the national market authorities with all the product information and documentation required to demonstrate the CE conformity of the product.
- Deliver a copy of the written mandate to the national regulatory authority, upon request.
The authorised representative is not responsible for ensuring the product’s safety design and manufacture or drawing up technical documentation. However, the EAR may draw up an EU declaration of conformity on the manufacturer’s behalf and under their responsibility if specified in the mandate. More about the EU authorised representative’s tasks.
#5. What would happen if you don’t appoint an authorised representative?
Simple said, if you don’t appoint an authorised representative, it is illegal to sell products to EU consumers. And, going against the law may cause a lot of issues for your company. For instance:
- If market authorities discover that you don’t have an EU authorised representative and refuse to appoint one, your product will be recalled.
- Any products shipped in packaging without information about an EU authorised representative are often seized and destroyed upon arrival. Thus, you’ll have to deal with the financial loss of the destroyed goods and also compensate your customers.
- If you sell products on Amazon, Amazon will check for the presence of an EU economic operator, and if such is missing, they will block the product.
#6. Should the authorized representative’s name appear on your product?
Short answer – yes, it should. Anyone buying your product should know who your EU authorised representative is. On the product’s packaging, you should print all the information related to your EAR (e.g. legal name, address and contact number). In case of a complaint, the authorised representative is immediately informed. Furthermore, if the EAR’s name doesn’t appear on the packaging, this can also alert the customs.
#7. Can you change the authorized representative after you appoint one?
If you’re unhappy with the quality of service you receive from your current authorised representative, you can appoint a new EAR. However, when taking such a decision, you need to address the following:
- The date of termination of the agreement with the outgoing authorised representative and the starting date of the new, incoming authorised representative.
- The date until which the producer can show the outgoing EAR on the product’s packaging and accompanying information.
- Additional costs related to changes in all product labels, packaging and manuals.
- The transfer of documents, including any property rights and confidentiality aspects.
#8. Can a distributor be an authorised representative?
Although a distributor can act as an authorised representative, it is not a good idea due to the following reasons:
- The legal name and address of the distributor will need to be printed on the product’s packaging and accompanying documentation. So, if you change distributors, you’ll need to reprint all packaging, labels, and manuals. And more, you’ll need to figure out quickly what to do about all the products already on the market.
- The distributor will need to have access to the product’s technical documentation
- Distributors are usually focused on the products’ marketing and sale, so they don’t typically stay up to date with the changes in the EU legislation.
#9. What if the authorised representative is in the UK, not in the EU?
If your authorised representative has their place of business in the UK, not in the EU, then you’re in trouble. You’ll need to appoint a new authorised representative who is located within the EU and can be your point of contact for the competent regulatory authorities.
Another thing to keep in mind is that the same applies to the Notified body. If your product needs to be assessed by a Notified body, pick one located within the EU.
#10. How to select an authorized representative?
When choosing a European authorised representative, follow this simple step-by-step procedure:
- Find an authorised representative who has been around for at least a couple of years, has experience with a broad range of products, and can provide compliance assistance.
- Choose one of their pre-defined service plans or ask for a custom-tailored contract that will meet your needs.
- Prepare all required paperwork (e.g. technical documentation, DoC) and share it with the EAR via email, cloud or other means.
- Use a digital tool to verify the completeness of your technical documentation or ask the authorised representative for their expert opinion regarding the CE conformity of your product.
- Sign an agreement with the authorised representative and receive a certificate of representation.
- Display the EAR’s name, address and contact details on your product’s packaging, labels and any other accompanying documentation.
#11. What products need an EU authorised representative?
All products falling within the scope of Regulation (EU) 2019/1020 need an EU authorised representative. For instance: aircraft, cosmetics, electronic products, measuring instruments, fertilisers, toys, textile products, tobacco products, radio equipment, batteries, construction products, cableway installations, and so many more.
#12. Is the EAR legally responsible for defective or non-compliant products?
Depending on what’s stated in the relevant EU legislation, the authorised representative may or may not be legally responsible for defective or non-compliant products. For instance, according to most CE marking regulations and directives, such as the Low Voltage Directive (LVD) and Toy Safety Directive (TOY), the European authorised representative does not hold any responsibility. However, if the product is covered by the Medical Device Regulation (MDR), the authorised representative is liable.
Generally, the manufacturer is responsible and liable for the products they place on the EU market. When the product is being imported, the EU importer must guarantee the product’s CE compliance.
#13. Which company can offer EU authorised representative services?
Clever Representative, a subsidiary of Clever Compliance, is a company in Sweden that helps non-EU businesses comply with the legal requirements of Regulation (EU) 2019/1020. Clever Representative has experience with a broad range of products, from electronic equipment to construction products to toys.
The Swedish company has integrated their EU authorised representative services into a self-built platform. Manufacturers can use the platform to store technical documentation, self-verity technical files for CE conformity and get certificates of representation within minutes. Users of the platform can also request authority or compliance assistance from regulatory experts whenever needed.
The annual fee for the platform depends on the number of products, starting at €228 for the first 15 products. For more information about Clever Representative’s services, visit their pricing page.