Non-phase in substances which have previously been notified under Directive 67/548/EEC and are documented in the European List of Notified Chemical Substances (ELINCS), do not need to be registered under REACH to be placed on the EU market. However, as the tonnage per year produced or imported in the EU reaches the next tonnage level (≥ 10 t/a, ≥ 100 t/a, and ≥ 1000 t/a), the obligations given under REACH (see table below) must be complied with. Before conducting further studies the registrant of a non-phase in substance shall inquire from the European Chemicals Agency (ECHA) whether a registration has already been submitted for the same substance.
Before placing a new substance on the EU market the substance has to be registered. Until 01.06.2008 the registration of substances exceeding 10 kg/a had to be submitted to the national agencies acc. to Directive 67/548/EEC. From 01.06.2008 the registration of substances exceeding 1 t/a need to be submitted to the European Chemicals Agency in Helsinki. The data requirements for a registration under REACH are given below in tabular format. However, before conducting studies a potential registrant of a new substance / non-phase in substance shall inquire from the Agency whether a registration has already been submitted for the same substance.
Outline overview of REACH registration requirements:
|Substance ≥ 1 t/a Studies acc. to Annex VII||Substance ≥ 10 t/a Studies acc. to Annexes VII - VIII||Substance ≥ 100 t/a Studies acc. to Annexes VII – VIII; Testing strategy for Annex IX||Substance ≥ 1000 t/a Studies acc. to Annexes VII – VIII Testing strategy for Annexes IX & X|
|Technical Dossier||Technical Dossier||Technical Dossier||Technical Dossier|
|Chemical Safety Report (CSR)||Chemical Safety Report (CSR)||Chemical Safety Report (CSR)|
The registration of an estimated ~30.000 phase-in substances is one of the major challenges under REACH, as for all these, the registration obligations outlined in the table above also need to be fulfilled. The registration of phase-in substances is gradual, with three deadlines, prioritised on the basis of tonnage produced/imported per year and with accelerated registration for carcinogens, mutagens, reproductive toxins (CMRs) and PBT / vPvB substances. The latter will also be included in REACH Annex XIV, meaning that authorisation is required for market approval.