Only Representative (OR)
REACH requires all companies manufacturing, importing or placing a substance on the EU market in quantities greater than 1 t/year to register that substance with the European Chemicals Agency (ECHA).
Article 3 (4), (9) and (11) of the REACH regulation further stipulates that registrants must be established in the EU. This means that non-EU companies are not permitted to register substances under REACH. However, they may still place substances on the EU market by appointing an Only Representative (OR) who takes on their obligations for ensuring that substances imported are compliant with REACH Regulation.
The advantages of appointing an OR include:
- Once appointed, the OR takes on the role of importer, representing all of the EU customers of the non-EU manufacturer.
- The OR completes the registration dossier on behalf of all of the EU importers – who then become downstream users.
- If an importer registers a product, the importing company will own the registration. With an OR the non-European manufacturer owns the registration and therefore maintains the flexibility to grow or change the number of European importers they do business with.
- You can gain advantages over other non-EU suppliers who do not appoint OR to register their substances;
As a consequence of Brexit, after 29 March 2019, all UK-based registrants will need to appoint a new Only Representative based in the EU to take over respective REACH registrations.
According to the Biocidal Products Regulation (BPR), prior to marketing your biocidal products in the EU, notification, registration and/or authorization are required. The authorization holder must be a legal entity based in one of the EU Member States. For UK based authorization holders, after Brexit, in order to maintain the validity of your biocidal product authorisations, they must be transferred as a matter of priority to a legal entity established in the remaining EU 27 Member States, EEA countries or Switzerland by using the relevant case types in R4BP 3 (NA-TRS, SA-TRS or UA-TRS).
Please note that the transfers have to be notified and implemented before the UK withdrawal. Similarly, all applicants should transfer, by using the transfer functionality embedded in the cases, all their ongoing R4BP 3 cases for which the prospective authorisation holder is a UK-based company.
At Kerona Scientific we have all the necessary skills, resources and experience to meet your Only Representative and Authorisation Transfer requirements. Please send an email to firstname.lastname@example.org or contact the team on +353 1 849 5284 if you would like to discuss this further.