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Enda representant för en tillverkare utanför EU

Who can appoint an only representative?
According to Article 8(1) of REACH, a natural or legal person established outside of the EU who manufactures substances (to be used on their own, in mixtures and/or to produce articles), formulates mixtures or produces articles, can nominate an only representative located within the EU to carry out the required registration of their substances that are imported (as such, in mixtures and/or in articles) into the EU. Distributors are not mentioned in Article 8(1) of REACH and thus cannot appoint an only representative.
The reference to the EU covers both the EU countries and the EFTA countries that have adhered to the EEA (European Economic Area) Agreement, that is Iceland, Liechtenstein and Norway.
The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation. More information on the only representative role is provided in section 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach
Who can be appointed as an only representative?

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 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

What is meant by the "sufficient background" of an only representative?
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.
Is there a special procedure to appoint an only representative?
The issue of becoming an only representative is a question of mutual agreement between the "non-EU manufacturer" and the natural or legal person established in the EU who is being appointed as an only representative.
"Non-EU manufacturers" need to send a letter confirming this appointment to their only representative who must have it available in case of inspection by the relevant Member State's enforcement authority. No such letter has to be sent to ECHA. However, when compiling the registration dossier in IUCLID 5 the only representative is advised to attach this letter of appointment to the registration dossier in the field "Official assignment from non EU manufacturer" in section 1.7. More information on the duties of the only representative is provided in section 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition the "non-EU manufacturer" shall inform the importer(s) within the same supply chain of the appointment of the only representative according to Article 8(3) of the REACH Regulation. These importers shall be regarded as downstream users.
Can an only representative represent more than one company?

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 'Only representative of a "non-EU manufacturer"' of the Guidance on registration.
How can "non-EU manufacturers" help their only representative or importers to prepare for registration?
The importer or the only representative is responsible for submitting a registration dossier or a pre-registration to take advantage from the extended registration deadlines for phase-in substances. In order to assist these actors under REACH, the "non-EU manufacturer" may wish to make himself aware of the information requirements laid down in REACH and start to collect the relevant information. This may include correct identification (CAS or EINECS/ELINCS/NLP) number and naming of the substance and information on its composition. This is explained in more detail in the Guidance for identification and naming of substances under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The "non-EU manufacturer" may also assist in providing all available information regarding the intrinsic properties of the substances (see Annex VII to XI of REACH). However, these supporting measures of the "non-EU manufacturer" cannot relieve the only representative or the importer from the duty to comply with all relevant obligations of the REACH Regulation.
More information for "non-EU manufacturers" can be found at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries
As an only representative, do I need to specify in the registration dossier the identity of the "non-EU manufacturer" I am representing?
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.
Have registered a substance as an only representative of a non-EU manufacturer. Does a change of the importers of the non-EU manufacturer trigger the need for an update of the registration, and would this update be subject to a fee?
The change of importers of a substance supplied by a non-EU manufacturer who appointed an only representative to register this substance does not trigger the requirement to update the list of importers indicated in section 1.7 of the IUCLID 5 dossier. However, the only representative is required, in accordance with Article 8 (2) of REACH, to keep available and up-to-date information on quantities imported and customers sold to.
Information on the importers may be reported in section 1.7 of IUCLID 5. Practical information on how to do this is provided in the Data Submission Manual 5, section 4.1.7: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
The update of this list of importers is not subject to any fee.
What are the obligations of polymer importers (or ORs appointed by non-EU polymer manufacturers), if an OR has already been appointed by the non-EU monomer producer up the non-EU supply chain, but this OR does not want to take on the legal responsibility envisaged in Article 8 of REACH for the polymer importers?
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.
If ORs have been appointed to fulfil the registration obligations of non-EU manufacturers but not their authorisation obligations, can the EU importer instead apply for authorisation? If so, under which role (importer or downstream user (DU))?

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.

I represent a manufacturer based outside the EU. The company will be absorbed by another non-EU company. As an only representative, do I have to notify ECHA about this change?

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.

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