Industrial Chemicals – REACH | Background

REACH obligations for manufacturers / importers if Non-Phase-In Substances and Phase-In-Substances

Non-Phase-In Substances / Notified Substances:

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.

Non-Phase-In Substance/ New substances

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
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Phase-In Substances

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.

  • Phase 1 (registration by 01.12.2010):
    • Substances ≥ 1,000 tonnes per year
    • Substances ≥ 100 tonnes per year that are classified as very toxic to aquatic organisms (R50/53)
    • Substances ≥ 1 tonne per year that are classified as Category 1 or 2 carcinogens, mutagens or reproductive toxicants
  • The first registration deadline has now passed and EBRC has successfully contributed to more than 60 registration dossiers for substances in the tonnage band >1000 tpy.
  • Phase 2 (registration by 1 June 2013):
    • Substances supplied ≥ 100 tonnes per year if not falling into Phase 1
  • Phase 3 (registration by 1 June 2018):
    • Substances supplied ≥ 1 tonne per year if not falling into Phase 1