Exporting to the EU - vital questions for machine builders

If you export to the European Union, you may have heard about EU Authorised Representatives and be wondering what they are. How do they differ from distributors or importers? What do they have to do? Who must have one and how are they appointed?

In this article, Hold Tech Files explains the new regulatory requirements and what you need to know about Authorised Representatives.

All the talk about Authorised Representatives (ARs) stems from the new European Union (EU) Regulation 2019/1020 on market surveillance and compliance of products. This came into force on 16 July 2021 with the aim of improving the ‘policing’ of markets in the EU to ensure products comply with applicable regulations and directives. Annex I of Regulation 2019/1020 lists approximately 70 product Directives that are affected by the new requirements. Examples from the industrial sector include:

• 2006/42/EC Machinery Directive
• 2014/30/EU Electromagnetic Compatibility (EMC) Directive
• 2014/35/EU Low Voltage Directive (LVD)
• 2014/29/EU Simple Pressure Vessels Directive (SPVD)
• 2014/68/EU Pressure Equipment Directive (PED)
• 2014/34/EU ATEX Equipment.

Other directives listed in Annex I cover products as diverse as personal protective equipment (PPE), toys and recreational craft.

While Regulation 2019/1020 places obligations on Member States and their market authorities, it also has important implications for manufacturers that export to the EU – and this includes the UK, now the UK has left the EU. Specifically, Regulation 2019/1020 introduces new requirements relating to an ‘economic operator’. Without an economic operator established in the EU, you are prohibited from placing goods on the market.

The economic operator is responsible for ensuring the conformity documentation is available, co-operating with market surveillance authorities and informing authorities if there are reasons to believe a product presents a risk.

Regulation’s scope

According to Regulation 2019/1020, an economic operator can be any of the following: the manufacturer; the importer; an authorised representative; or a fulfilment service provider when none of the foregoing is established in the EU. Article 3 of the Regulation provides definitions for these four terms.

If a manufacturer is based outside the EU, the options for an economic operator are restricted to an importer, AR or fulfilment service provider. For industrial products or those where regulatory compliance is complex, it is unlikely that either the importer or fulfilment service provider will be competent or willing to take on the responsibilities of being the economic operator. Furthermore, if a manufacturer appoints an importer as the economic operator, this could entail sharing valuable intellectual property contained in technical files, which manufacturers will be reluctant to do. This leaves an AR as the only viable option.

An AR is defined in Regulation 2019/1020 as any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of the Regulation.

Competency requirement

Appointing an AR may seem like a simple administrative exercise, but note that the AR needs to be competent to understand the conformity documentation and ensure it is suitable for purpose, and must be capable of responding to enquiries from market surveillance authorities.

To bolster market surveillance, the EU has established a Union Product Compliance Network. This serves as a platform for structured co-ordination and co-operation between enforcement authorities of the Member States and the European Commission. In addition, it streamlines the market surveillance within the EU and makes market surveillance more effective. This new Union Product Compliance Network makes it all the more important that manufacturers meet the requirements relating to economic operators. If customs checks on documentation reveal there is no economic operator established in the EU, goods can be held at customs.

For manufacturers outside the EU needing to appoint an EU AR, Hold Tech Files Ltd is based in the Republic of Ireland and is therefore established in the EU as required by Regulation 2019/1020. The company offers a service whereby it acts as an AR for any of the Directives listed in Annex I. This includes the Directives relating to industrial products as well as others ranging from aerosol dispensers, boilers and fertilisers, through to chemicals (REACH), cosmetics and weighing instruments.

Machinery marking protocol

Although the Machinery Directive 2006/42/EC predates Regulation 2019/1020, one of the Machinery Directive essential health and safety requirements (1.7.3) states that the machinery must be marked visibly, legibly and indelibly with the business name and full address of the manufacturer and, where applicable, his authorised representative. In effect, this means the AR’s details must be provided on the manufacturer’s plate on the machine.

For machine builders, system integrators and suppliers of safety components falling within the scope of the EU Machinery Directive, the new requirement in Regulation 2019/1020 for an economic operator is additional. Manufacturers outside the EU must still name a person established in the EU on the Declaration of Conformity (DoC) or Declaration of Incorporation (DoI) as being authorised to compile the technical file. For clarity, it would be advisable to name the person authorised to compile the technical file separately from the AR, even though it is simplest if both are, in fact, the same person.

As well as being appointed as an AR, Hold Tech Files can also be named on the DoC or DoI as the person authorised to compile the technical file. For this second service, Hold Tech Files has created a simple web-based portal where clients can sign a mandate, pay a fee and upload the relevant file to a secure server. The client is then entitled to name Hold Tech Files on the DoC or DoI for a period of up to 10 years. This period can be extended, the files modified or updated, and more products added, all via the self-service portal.