ECHA

Doing the work for you

 

Using an only representative reduces the responsibilities of importers, as they will be regarded as downstream users. In many cases, it offers an easier option for non-EU manufacturers to gain access to the EU/EEA market.

 

Appointing an only representative also gives non-EU based manufacturers direct control over the registration process, without having their importers register.

 

"Only representatives work as a neutral partner, which means that the non-EU manufacturers do not have to disclose their confidential data to their importers and the supply chain. This can provide a competitive advantage as there will be fewer bureaucratic hurdles," Dr Drohmann says.

 

Only representatives handle their non-EU manufacturers' confidential information securely, and can submit pre-registrations, inquiries, registrations, classification and labelling notifications, notifications for product and process-oriented research and development (PPORDs) and authorisation applications.

 

"For the range of services offered, keeping communication channels open is vital. The only representatives communicate directly with ECHA, enforcement authorities, substance information exchange forums, consortia and other actors in the supply chain, which can reduce the workload for the non-EU manufacturers and importers and allow them to dedicate more time to their core business activities," Dr Drohmann tells.

 

"Also, since only representatives are able to represent several manufacturers, even if they produce the same substance, the manufacturers can further benefit from the synergies of their only representatives having hands-on experience of registering the same substances," he adds.

 

 

REACH education

 

One of the greatest challenges faced by only representatives is educating their non-EU manufacturers about what needs to be done to register their substances.

 

"Often, non-EU manufacturers are not aware of what needs to be done to register a chemical. It would be helpful if ECHA could provide an official guideline summarising the steps for non-EU manufacturers needing to register chemicals. ORO would like to help by educating non-EU manufacturers and importers," Dr Drohmann says.

 

Another challenge for only representatives is enforcement. They must record the substance and volume base for which importers are covered by their activities for the enforcement authorities. Therefore, it is essential to receive the correct volumes and details from non-EU manufacturers.

 

"Importers need to know that they should request written statements from their non-EU suppliers. Inspections and training for importers can help to raise this awareness and make them understand that they need written, volume-based coverage," Dr Drohmann says and adds, "the different levels of enforcement across Member States, particularly on who is responsible for the content and quality of safety data sheets, is also an area that should be clarified".

 

 

Non-EU company: be transparent

 

To help only representatives prepare high quality registrations, non-EU companies need to be transparent and give information on what levels of activity the only representative should be involved, e.g. in SIEFs or consortia, and in which tonnage band the registration is planned. "Only representatives also need to know about data ownership and substance identification as well as have the correct information about the company size of the non-EU manufacturer," Dr Drohmann highlights.

 

"Mutual trust between the only representative and the non-EU company is essential. It is very important that the non-EU company selects a professional and experienced only representative since the tasks are complex, specialised and REACH is still relatively new to everyone".

 

"It is also good to remember that the only representative role does not stop with the registration of a substance. The service continues with dossier updates, safety data sheet supply tracking and importer and substance volume tracking each year," Dr Drohmann concludes.

 

 

ORO's top tips for non-EU companies   Choose your only representative wisely and set up a detailed and fair contract for both parties. For advice, consult ORO.   To prevent contractual disputes later on, remember to add a clause in your contract reflecting a possible change of your only representative.   If you change your only representative, make sure that the substances in your REACH-IT account are transferred to the new only representative.   Read and follow ECHA's advice on data sharing. If you purchase a letter of access, make sure that it complies with the new implementing regulation on data sharing.

 

Only Representative Organisation (ORO)   ORO represents the majority of only representative service providers. It currently has 33 full members in 11 Member States and one associated member in Turkey.   ORO members represent more than 2 000 non-EU manufacturers, with the majority located in Asia.   ORO members cover over 16 000 chemicals already registered or pre-registered and provide coverage for more than 20 000 EU importers located all over the EU/EEA. So far, around 3 200 REACH registrations have been submitted.   For the first and second REACH registration deadlines, only representatives conducted 20 % and 25 % of all REACH registrations, respectively.   For the 2018 deadline, it is expected that more than 25 % of all registrations will be done by only representatives, mostly on behalf of small non-EU manufacturers.   http://www.onlyrepresentative.org

 

 

Further information:

 

 

Text by Paul Trouth
Top image: Fotolia