Notification procedure for existing substances
With the entering into force of the REACH Regulation (EC) No 1907/2006, Regulation (EEC) No 793/93 on the Evaluation and Control of the Risks of existing substances was repealed as of 1 June 2008.
Article 136 of the REACH Regulation established a transitional procedure to deal with the remaining information requirements with regard to existing substances under REACH.
Article 136 (1)
- The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 10 (2) of Regulation (EEC) No 793/93 (Existing Substances Regulation), shall be considered as decisions adopted in accordance with Article 52 of the REACH Regulation. The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 120 (1) of Regulation (EEC) No 793/93 and shall carry out the tasks of Article 46 (3) and Article 48 of the REACH Regulation.
Article 136 (2)
- The requests to manufacturers and importers to submit information to the Commission made by a Commission Regulation in application of Article 12 (2) of Regulation (EEC) No. 793/93, shall be considered as decisions adopted in accordance with Article 52 of the REACH Regulation. The Agency shall identify the competent authority for the substance to carry out the tasks of Article 46 (3) and Article 48 of the REACH Regulation.
Therefore, under the REACH Regulation Industry must still meet the information requirements as adopted under the Existing Substances Evaluation and these must be submitted to the European Chemicals Agency in Helsinki. In the case of information concerning priority substances under the Existing Substances Regulation the competent authority is the authority of the Member State identified as rapporteur. In the case of requests for other existing substances the Agency designates the competent authority.
Moreover, when preparing their registration documents, in particular the substance safety report, registrants must take into account the results of the evaluations made under the Existing Substances Evaluation. If these differ from the results of the Existing Substances Evaluation, the reasons for the differences must be explained in detail. It must be considered that the data protection regulations also apply to studies used in the evaluation. Before the studies are used, ownership must be clarified and permission to refer to them may be obtained.
For the substances for which Germany was the rapporteur, the table lists the risk assessment reports (RAR) and the risk reduction strategies (RRS) if such exist (OJ = Official Journal of the European Commission):