Ever since the introduction of the mandatory requirement of an European Authorized Representative (EAR) for any manufacturer based outside of the European Union looking to introduce products to the European market under General Product Safety Directive 2001/95/EC, many manufacturers have been expressing concerns on what the accepted limits, boundaries, and responsibilities are in the relationship between manufacturer and EAR. One of the most fundamental aspects to understand when working with a European Authorized Representative to bring your products to the European Market is knowing what obligations fall upon you as a manufacturer and what information and documentation must be supplied to and handled by your EAR. Understanding the basics in this way can help keep liability on the correct party and avoid unnecessary complications in the relationship which may be problematic down the line.
To understand which obligations are on which party, it is first important to understand the function of the Authorized Representative. GPSD 2001/95/EC, introduced on January 15, 2004, established in law the requirement for any manufacturer based outside the European Union to elicit the services of an Authorized Representative to handle their interests inside the European Union. The idea is to achieve greater consumer safety, as well as increase transparency and harmonization on the EU market. The duties of an EAR can include:
- Providing the manufacturer with a registered address in the European Union
- Making all relevant technical documentation available for inspection by the European Authorities
- Completing the notification process to European Authorities
- Completing registration processes to national databases when necessary
- Incident reporting
- Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
- Safeguarding compliance with constant regulatory update
- Consulting and advising the manufacturer on European Regulations
While all the above duties fall upon the EAR, according to Directive 2001/95/EC, it is important to note that the actual process of ensuring all products are in full compliance with the directive (and any other applicable European directive) are entirely on the manufacturer and all penalties or repercussions of non-compliance will fall to the manufacturer too. This is important to note as pushing the boundaries of the manufacturer-EAR relationship may lead to some serious consequences.
The largest risk a manufacturer runs in pushing the terms of agreement with an EAR in regards responsibility and liability is the potential termination of the agreement. As dictated in 2001/95/EC, without an established representative inside the European community, a manufacturer based outside of Europe may not place products on the European market. As a result, products found to be non-compliant in this way may face market withdrawal or even an outright ban.
One knock-on effect of this is that agreements ended in this way can often make it harder for a manufacturer to establish a relationship with a new EAR. This can leave manufacturers locked out of the European market as a result or open to any other combination of avoidable consequences. It is for that reason that it is advisable for all manufacturers to be fully aware of all responsibilities required of them in such situations, and to employ the services of a knowledgeable EAR who can keep them informed of the correct processes and procedures.
For more information on product compliance issues under Directive 2001/95/EC (or any other EU Directive or Regulation your product may be subject to), to get a free quote on Obelis’ Authorized Representative or CE Marking services, or from advice from our team of EU regulatory experts, contact us today.