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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.
Yes, an only representative can represent one or several non-EU companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance.
If an OR is appointed by several non-EU companies, then the OR needs to create several OR accounts in REACH-IT, one for each non-EU company they represent. There should be a 1-to-1 correspondence between an OR account in REACH-IT and the non-EU company they represent. If the same legal entity covers the role of a manufacturer/importer and the role of an OR, then they will need to create two different accounts in REACH-IT: one account for their role as manufacturer/importer and another account for their role as OR.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.
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 personality in this case you need to:
- Create a new account in REACH-IT for your company to represent the new legal entity, reflecting their size. Note that in the "Company Size" information, you must indicate the size of the non-EU/EEA manufacturer you are representing and not the size of your own legal entity.
- Initiate a legal entity change (only representative changes)
- 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'
- Submit a spontaneous update in the new legal entity to report the change in the dossier
You may need to pay a fee to complete the process. More information related to the outcome of a legal entity change can be found at Q&A 388.
As an only representative, you are fully responsible and liable for fulfilling all obligations of importers for the substances you are responsible for. These do not only pertain to registration but also to all other obligations of importers under REACH. As an only representative, you need to register the imported quantities depending on the contractual arrangements with the ‘non-EU manufacturer'.
You can represent one or several ‘non-EU manufacturers'. If you act on behalf of several ‘non-EU manufacturers', you must submit a separate registration for each of these manufacturers.
Your registration dossier should contain all uses of the importers covered by the registration. You need to keep an up-to-date list of importers within the same supply chain of the ‘non-EU manufacturer' and the tonnage covered for each of them, as well as information on the supply of the latest update of the safety data sheet.
For further information see chapter 220.127.116.11 "Only representative of a non-EU manufacturer" in the Guidance on registration: