Questions and Answers
A non-EEA company (that can appoint an only representative, see FAQ ID=15) may, by mutual agreement, appoint a natural or legal person established in the European Economic Area (EEA) to act as his only representative. According to Article 8(2) of REACH this representative shall comply with all obligations of importers under REACH. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. More information on the only representative is also provided in section 188.8.131.52- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
There are no detailed requirements or criteria regarding what is regarded as "sufficient background in the practical handling of substances and the information related to them" other than what is laid down in Article 8(2) of REACH.
Yes, an only representative can represent one or several non-EEA companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance. More information on the duties of the only representative is provided in section 184.108.40.206- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
An only representative must be able to document who he is representing (i.e. the name of the non-EU manufacture should be given in section 1.7 of IUCLID) and is advised to attach a document from the "non-EU manufacturer" appointing him as only representative in section 1.7 of IUCLID. It is not mandatory to include this information in the registration dossier, but it needs to be presented to the enforcement authorities upon request. Furthermore an only representative is advised to include the "list of importers" in section 1.7 in IUCLID.
In the case of polymer imports, the condition "have already been registered up the supply chain" in Article 6(3) REACH can only be fulfilled if an OR appointed up the non-EU supply chain (e.g. the OR of the non-EU monomer manufacturer) has decided to also cover the polymer imports with their registration (i.e. included the volumes concerned in their registration and took over the obligations in Article 8(2) and 8(3) of REACH). If the OR of the non-EU monomer manufacturer decides not to take legal responsibility for these volumes, the polymer importer cannot rely on the exemption from registration and is obliged to register the volumes of monomer they import. Alternatively, an OR appointed by the non-EU polymer manufacturer could register on behalf of the polymer importers.
EU importers of a non-EU manufacturer can apply for an authorisation irrespective of whether they are covered by an OR for registration of the Annex XIV substance. If the appointment of the OR does not extend to also cover the fulfilment of the obligations of the importers with regard to authorisation, then the importers themselves can apply for an authorisation. In such a case, the importers will apply in their role as importers of an Annex XIV substance. Furthermore, the importers are not required to indicate the name of the non-EU manufacturer or the OR in their application for authorisation sent to ECHA, since the OR’s appointment and their respective obligations are limited to the registration of the Annex XIV substance.
Yes, you need to notify ECHA about this change. You represent the non-EU manufacturer and, therefore, you need to communicate changes in their legal personality. You can notify ECHA using the legal entity change functionality in REACH-IT.
To change the legal entity you need to:
- create a new account to represent the new legal entity, reflecting their size;
- follow the instructions in ‘Change of OR’ from Industry User Manual 17;
- include documents which clearly explain how you represent the new non-EU manufacturer;
- update the IUCLID files, in particular section 1.7 ‘Only Representative information’.
You may need to pay a fee to complete the process.