Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the single market, must have an authorised representative – in particular products that require CE marking.
In practice, this means that non-EU companies pay EU entities to act as their authorised representative. Further, the packaging must also include the name and address of the authorised representative.
In this guide, we explain how this works in practice, and what the consequences can be if you don’t have an authorised representative.
1. This guide only covers EU AR requirements within the scope of the Market Surveillance Regulation (EU) 2019/1020. If you are looking for authorised representative requirements concerning medical devices, then you can find the relevant article here.
2. This guide covers authorised representative requirements in the UK.
What is an EU authorised representative?
An authorised representative acts on behalf of non-EU entities selling to consumers in the EU. An authorised representative must be a legal entity registered in an EU member state, and they must perform the following tasks, as stated under Article 4:
2. Keep a record of the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensure that the technical documentation can be made available to those authorities upon request*
*Normally 10 years.
Note: This means that non-EU sellers must provide a full set of compliance documents to the EU AR.
Communicate with national market surveillance authorities
1. Provide the national market surveillance authorities with all information and documentation necessary to demonstrate conformity. This can include the following:
- Test reports
- Risk assessment
- Product labels
- Packaging labels
2. When having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof.
Cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance.
Product packaging information
The following information must be affixed on the product packaging:
1. The company name of the EU authorised representative.
2. The postal address of the EU authorised representative.
In short, the EU AR requests and verifies documentation from the seller which supports that their products are compliant. As needed, they also communicate with the national market surveillance authorities in case they take action against the products due to compliance issues.
Why do I need an authorised representative?
It is mandatory to have an authorised representative If you are established outside the EU and sell products that are covered by this requirement.
The customs authorities have the right to seize and destroy incoming shipments without an EU authorised representative address. In practice, this can result in the following for non-EU companies selling without an EU AR:
1. They can no longer sell through Amazon FBA.
2. They cannot ship from fulfilment centres (and could possibly face issues with freight forwarders at some point).
3. They must deal with a higher number of failed shipments (that the customers never receive as the package is seized and destroyed without compensation).
Which products require an authorised representative?
The Market Surveillance Regulation does not provide a product scope or product list. Instead, Article 4(5) states that the EU AR related provisions apply to the following regulations – which in turn covers products within a defined scope.
|Regulation name||Product name/scope|
|Construction Products Regulation (EU) 305/2011||Construction products|
|Personal Protective Equipment Regulation (EU) 2016/425||Personal protective equipment|
|Appliances Burning Gaseous Fuels Regulation (EU) 2016/426||Gas appliances and fittings|
|Noise Emissions in the Environment Directive 2000/14/EC||Equipment for use outdoors (machinery)|
|Machinery Directive 2006/42/EC||Machinery|
|Toy Safety Directive 2009/48/EC||Toys|
|Ecodesign Directive 2009/125/EC||Energy-related products|
|RoHS Directive 2011/65/EU||Electrical and electronic equipment|
|Pyrotechnic Articles Directive 2013/29/EU||Pyrotechnic articles|
|Recreational Craft Directive 2013/53/EU||Recreational craft and personal watercraft|
|Simple Pressure Vessels Directive 2014/29/EU||Simple pressure vessels|
|EMC Directive 2014/30/EU||Electrical and electronic equipment|
|Non-automatic Weighing Instruments Directive 2014/31/EU||Non-automatic weighing instruments|
|Measuring Instruments Directive 2014/32/EU||Measuring instruments|
|ATEX Directive 2014/34/EU||Equipment and protective systems intended for use in potentially explosive atmospheres|
|Low Voltage Directive 2014/35/EU||Electrical and electronic equipment|
|Radio Equipment Directive 2014/53/EU||Radio equipment|
|Pressure Equipment Directive 2014/68/EU||Pressure equipment|
Is an authorised representative required for CE marked products?
Yes, if your company is located outside the EU and you are selling products that fall within the scope of one or more CE marking directives listed in Article 4(5) to consumers, then you must have an authorised representative.
What kind of companies need to use a European authorised representative?
This is written under point 18:
The economic operators who should perform those tasks are the manufacturer, or the importer when the manufacturer is not established in the Union, or an authorised representative mandated by the manufacturer for this purpose, or a fulfilment service provider established in the Union for products handled by it when no other economic operator is established in the Union.
Here’s an overview of different businesses and how the EU AR requirements may impact them.
Cross-border e-commerce sellers
Cross-border sellers are probably the main target. This makes sense, as cross-border sellers from China, and elsewhere, are shipping products that fail to meet EU safety standards, labelling, and documentation requirements. As of 2021, cross-border sellers need an EU authorised representative.
Non-EU based manufacturers
Manufacturers selling directly to consumers in the EU must also have an authorised representative, for the same reasons as explained above. This is not the case for manufacturers selling B2B to EU-based importers.
Companies selling from fulfillment centers
This is stated on the EU website:
In order to ensure that market surveillance authorities can carry out their responsibilities effectively and to avoid a gap in the enforcement system, it is appropriate to include fulfilment service providers within the list of economic operators against whom it is possible for market surveillance authorities to take enforcement measures.
This is further clarified by SGS:
The fulfillment service provider becomes responsible when there is no representative in the EU (a fulfillment service provider is a person or company offering at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved; courier and postal companies are specifically excluded).
In short, fulfilment centres must implement measures to verify product compliance for sellers shipping products to the EU.
This is stated in the Amazon Seller Central:
If you sell CE-marked products that are manufactured outside of the EU, you will need to ensure that such products have a Responsible Person in the EU prior to July 16, 2021. After July 16, 2021, it will be illegal to sell CE-marked products in the EU without an EU Responsible Person. All CE marked products are covered by this rule except for medical devices, explosives for civil uses, and certain lifts and cableway installations.
Amazon is also offering its own authorised representative service for FBA sellers. That being said, they only accept you as a customer as long as you can prove that your products are fully compliant, tested, correctly labelled, and documented.
Do EU importers need an authorised representative?
EU-based importers cannot use an authorised representative as they are already responsible for the products they import. This responsibility cannot be transferred to another company.
Where can I find an authorised representative?
There are many companies offering authorised representative services in the EU. For example, ProductIP offers a yearly service package from 2000 EUR. In addition, they also charge 225 EUR per hour if they need to act on behalf of a non-EU company – for example when communicating with market surveillance authorities.
Here are some companies offering EU AR services:
- AR Experts
- Authorised Rep Compliance
- TerrainQ Market Access
- Authorised Representative Service
- Certification Company
- Obelis Group
- Clever Representative
You can find more information on this page.
How much does an authorised representative cost?
The price differs between service providers. For example, here is the current pricing offered by ProductIP:
- Annual fee: 1800 EUR
- Hourly rate: 225 EUR
- Deposit: 2000 EUR
Note that these rates are subject to change and may already be outdated.
What kind of documentation is needed from the seller?
The exact documentation depends on the product, and how strict the authorised representative is. Here is a general overview:
- Test reports
- Declaration of Conformity
- Technical documentation
- User manual
- Product images
- Product labels
- Packaging artwork
Business license/company registration document
You must provide a business license or other evidence of incorporation. This differs depending on the country and jurisdiction.
Product liability insurance
This is often easier said than done, especially for foreign companies. Further, product liability insurance providers also require the submission of compliance documents in many cases.
United Kingdom: Certificate of Incorporation
Hong Kong: Business Registration Certificate
EU AR Agreement
Here is an example of an EU authorised representative Service Agreement which covers the following:
- Service scope
- General terms
- Authorised Representative’s Duties and Responsibilities
- Covered regulations/directives
Note that this list is based on ProductIP’s document requirements. The documentation requirements may vary depending on the service provider.
Can non-EU companies act as authorised representatives?
No, that would defeat the entire purpose of having an authorised representative in the first place.