Article

Commission Implementing Regulation Clarifies Rules for Phase-in Substances under REACH

Posted on: October 22, 2019

by Dr. Martina Schneider

Chemist in lab - Learn more - Commission Implementing Regulation Clarifies Rules for Phase-in Substances under REACHOn October 10, 2019, the European Commission clarified which provisions for phase-in substances will apply after December 31, 2019. Under Regulation (EC) No 1907/2006 (REACH), the so called phase-in substances were able to benefit from a transitional regime by allowing a later registration and calculation of annual tonnage based on a three years average. By definition, phase-in substances were substances that were already being manufactured or placed on the market before the entry into force of the REACH Regulation (REACH Article 3).

May 31, 2018 was the final registration deadline and consequently on June 1, 2018, the formal operation of the Substance Information Exchange Fora (SIEF) ceased. Consequently, the European Commission issued the Commission Implementing Regulation (EU) 2019/1692 on October 10, 2019 to establish a cutoff date for the special conditions for phase-in substances.

After the cutoff date of December 31, 2019:

  • The production/import volume calculation methods based on the three years average will not apply any more for phase-in substances. Instead the volume calculation will be based on the calendar year.
  • Already submitted pre-registrations are no longer valid and potential registrants would have to follow the inquiry process set out in REACH Article 26 . To begin data sharing negotiations, an inquiry would need to be submitted to ECHA to obtain information on other registrants.
  • Phase-in substances in the 1 to 10 tonnage band range that do not meet the REACH Annex III criteria will continue to benefit from the less stringent information requirements (REACH Article 12).

Actions:

  • Reconsider the volume calculation for your substances and be prepared to fulfill additional registration requirements
  • Be prepared to follow the inquiry process before submitting a registration, even if company has submitted a pre-registration for that substance in the past

References:

Commission Implementing Regulation (EU) 2019/1692: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.259.01.0012.01.ENG&toc=OJ:L:2019:259:TOC

Regulation (EC) No 1907/2006 (REACH): https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX:32006R1907

Keywords:

  • REACH
  • Phase-in substances
  • European Union

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