Authorized EU Representative Requirement for EU Shipments

I fielded a question from a prospective customer yesterday regarding the requirement for an Authorized Representative for EU shipments. We always refer to it as an Authorized EU Representative at F2 Labs to avoid confusion. The customer read an article referencing a European regulation that appears to require that all exporters to the EU appoint an Authorized EU Representative. That is not accurate.

The regulation is Regulation (EU)2019/1020. Before yesterday I had never heard of it. Don’t worry… I read all 44 pages of it so you do not have to.

Immediately below is the summary of my email to the customer. After that I have pasted the entire email and how I worked through this.

Summary

The summary is this: you are not bound by Regulation (EU)2019/1020 but whoever is handling your products in the EU is. You must assist them in good faith (hand over the Technical File if requested by the authorities, you need to include a declaration of conformity, your products must comply) but you do not have to appoint an Authorized EU rep in almost all cases.

Detailed explanation

Regulation (EU)2019/1020 does make requirements of various categories of economic operators in the EU but it does not require an Authorized EU Representative for every product.

See Article 4 (1):
1. Notwithstanding any obligations set out in applicable Union harmonisation legislation, a product subject to legislation referred to in paragraph 5 may be placed on the market only if there is an economic operator established in the Union who is responsible for the tasks set out in paragraph 3 in respect of that product.

Next see the economic operators defined in Article 4(2)

(a) a manufacturer established in the Union;

(b) an importer, where the manufacturer is not established in the Union;

(c) an authorised representative who has a written mandate from the manufacturer designating the authorised representative to perform the tasks set out in paragraph 3 on the manufacturer’s behalf;

(d) a fulfilment service provider established in the Union with respect to the products it handles, where no other economic operator as mentioned in points (a), (b) and (c) is established in the Union.

I assume you are not in the EU, therefore you cannot assume any of the roles in Article 4(2).

So, what now?

An economic operator must be established in the EU for your product. So, one of the above must assume these duties (Article 4(3)):

(Please find my specific comments and responses in bold italics below each)

Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:

(a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up, keeping the declaration of conformity or declaration of performance at the disposal of market surveillance authorities for the period required by that legislation and ensuring that the technical documentation can be made available to those authorities upon request;

You need to send an EU declaration of conformity with the product and agree to hand over the technical file to the authorities (not your customer or distributor) upon request from the authorities.

(b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority;

See answer above. The importer must have assurance from you that you will provide this information to the authorities. But only the authorities can request it.

(c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof;

(d) 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 with the requirements set out in Union harmonisation legislation applicable to the product in question, or, if that is not possible, to mitigate the risks presented by that product, when required to do so by the market surveillance authorities or on its own initiative, where the economic operator referred to in paragraph 1 considers or has reason to believe that the product in question presents a risk.

Not your responsibility. You do not meet the criteria of an economic operator per Article 4 (2.).

Next, see Article 4 (4):

Without prejudice to the respective obligations of economic operators under the applicable Union harmonization legislation, the name, registered trade name or registered trade mark, and contact details, including the postal address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.

I noticed that this product is in scope of the EMCD 2014/30/EU.

Please see Article 7, obligations of manufacturers from 2014/30/EU:

Obligations of manufacturers

1. When placing their apparatus on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I.

2. Manufacturers shall draw up the technical documentation referred to in Annex II or Annex III and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out. Where compliance of apparatus with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the apparatus has been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Directive. Changes in apparatus design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared shall be adequately taken into account.

5. Manufacturers shall ensure that apparatus which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus.

6. Manufacturers shall indicate, on the apparatus, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

7. Manufacturers shall ensure that the apparatus is accompanied by instructions and the information referred to in Article 18 in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.

8. Manufacturers who consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with this Directive shall immediately take the corrective measures necessary to bring that apparatus into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the apparatus presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the apparatus available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the apparatus with this Directive, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.

Next, see the definition of manufacturer per 2014/30/EU, Article 3,(11):

‘manufacturer’ means any natural or legal person who manufactures apparatus or has apparatus designed or manufactured, and markets that apparatus under his name or trade mark;

Note: Nowhere is the location of the manufacturer specified as in the EU (as is the case for Regulation (EU)2019/1020.

Manufacturer responsibilities per 2014/30/EU are different than those per Regulation (EU)2019/1020. Please read it – nowhere does it require an EU address for you or an Authorized EU rep.

To accentuate this point, please see Article 8 (1.) from 2014/30/EU:

Article 8, Authorised representatives

1. A manufacturer may, by a written mandate, appoint an authorised representative.

IMPORTANT TAKE-AWAY: You may, not shall, appoint an authorized EU representative.

Finally, see Article 5 from Regulation (EU)2019/1020.

Article 5, Authorised representative

1. For the purposes of point (c) of Article 4(2), the authorised representative shall be mandated by the manufacturer to perform the tasks listed in Article 4(3), notwithstanding any other tasks mandated under the relevant Union harmonization legislation.

2. The authorised representative shall perform the tasks specified in the mandate. It shall provide a copy of the mandate to the market surveillance authorities upon request, in a Union language determined by the market surveillance authority.

3. Authorised representatives shall have the appropriate means to be able to fulfil their tasks.

Yes, it reads strongly that the authorized rep “shall” be mandated by the manufacturer. But, what it means is that if there is an authorized rep it must by mandate (written agreement). You are not required to have one.

The summary is this: you are not bound by Regulation (EU)2019/1020 but whoever is handling your products in the EU is. You must assist them in good faith (hand over the Technical File if requested by the authorities, you need to include a declaration of conformity, your products must comply) but you do not have to appoint an Authorized EU rep in almost all cases.

I hope this helps.

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