Within REACH, the pre-registration and the registration cannot be done by the Indian companies exporting to Europe. The exporting companies individually or collectively (in case of companies exporting the same substance to Europe, shall have to appoint a legal entity, who shall be based in Europe and do the pre-registration and subsequently registration on their behalf. An only representative is fully liable for fulfilling all obligations of importers for the substances he is responsible for as a registrant. These do not only pertain to registration but also all other relevant obligations such as pre-registration, communication in the supply chain, notification of substances of very high concern (SVHC), classification and labelling and any obligations resulting from authorisations or restrictions etc.
It should, however, be pointed out that the use of the only representative facility creates the need for exact documentation on which imported quantities of the substance are covered by the only representative registration and which imported quantities are not. The only representative will need this information to fulfil his obligation under Article 8(2) to keep available and up-to-date information on quantities imported and customers sold to. Moreover, the importer will also need to know whether a concrete quantity of the substance in a preparation is covered by the registration of the only representative of the substance manufacturer, as he would otherwise be subject to a registration requirement himself. This documentation will need to be presented to the enforcement authorities upon request.
The registration dossier of the only representative should comprise all uses of the importers (now downstream users) covered by the registration. The only representative shall keep an up-to-date list of EU customers (importers) within the same supply chain of the “non-Community manufacturer” and the tonnage covered for each of these customers, as well as information on the supply of the latest update of the safety data sheet.
For phase-in substances the only representative will have to pre-register the substance in order to benefit from the extended registration deadlines and will subsequently become participant of the Substance Information Exchange Forum (SIEF) (see section 3.4 of the Guidance on data sharing).
Although the only representative is legally responsible for the registration, it can be anticipated that in most cases, it will be the “non-Community manufacturer” that will provide him with all necessary data for his registration dossier. If a ”non-Community manufacturer” decides to change his only representative, the successor can submit an update of the earlier registration dossier provided that the earlier only representative agrees to this change. This agreement needs to be documented in the update. In order to prevent disputes, it is recommended to include clauses on the eventuality of a later change of the only representative in the contracts between the “non-Community manufacturer” and the only representative.
In the absence of an agreement by the earlier only representative, the successor will have to submit a new registration dossier. In this latter instance, it is nevertheless possible that the former only representative agrees to make available the data and dossier for reuse for the new only representative to prepare his registration dossier.
The responsibilities of “only representative” can be summarized as follows:
- To make the pre-registration and fulfill other obligations on behalf of the non EU manufacturer
- To accept official role on SIEFs
- Agree on hazard assessment for single registration (CSA)
- Agree on data gaps
- Agree on costs of sharing data
- Agree on new testing strategies
- To identify and agree to work with importers/down stream users (DUs)
- To consider exposure scenarios of DUs (and in turn, their customers etc)
- To organise CSR (either prepare themselves or helps DUs)
- To organise and agree on SDSs to be consistent with Registration details
- To be a part of joint submission when other manufacturers, importers or representatives exist for the same substance.
- To make Registration (pay fees!)
- To monitor supply patterns (volumes of import by each importer, SDS checks, etc.)
- To check whether risk management measures are being communicated or not.
Only Representative