Commission Implementing Regulation (EU) 2019/1692 was published on 9 October 2019 and updates the rules regarding pre-registrations, data sharing, tonnage band calculations and data-sharing disputes.
The method for registering phase-in chemicals under REACH was a temporary measure and should have ended on 31 May 2018. However, all existing pre-registrations will be deleted on 31 December 2019, after which, some conditions stipulated in REACH for phase-in substances will no longer apply.
All users of REACH need to pay attention to the clarifications made in the Implementing Regulation published on 10 October 2019, which has been added at the end of this article.
The important changes in the Commission Implementing Regulation (EU) 2019/1692 are;
- After the cut-off date, manufactured or imported tonnages will be calculated per calendar year for each of their substances and not as a 3 year rolling average as with phase-in substance.
- Data sharing agreement should be conducted in an informal style as with registering phase-in substances.
- After the cut-off date any registration will commence with the submission of an inquiry dossier. The response from ECHA will initiate data-sharing negotiations as pre-registrations will have been deleted.
- Any data-sharing disputes which originate from a substance information exchange forum (SIEF), should be submitted according to Article 30(3) of REACH until the cut-off date. After this date, data-sharing disputes will be decided according to Article 27.
- Phase-in substances in the 1-10T/a band will continue to benefit from requiring less information if they do not meet the criteria listed in Annex III to REACH.
If you are intending to register any substances under UK REACH, DEFRA recommends that you keep copies of your pre-registration numbers. This is because after leaving the EU access to ECHA REACH-IT accounts will be no longer be possible.
Cambridge Environmental Assessments, part of RSK ADAS Ltd., are highly experienced at ensuring compliance with EU REACH. If you need help with this new implementation regulation or have other issues with regard to EU Chemical regulatory compliance please contact Neil Stearn, Peter Godfrey or Sarah Henly.
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Implementing Regulation concerning phase-in substances
Calculation of quantities of phase-in substances
1. The specific method for calculating quantities per year of phase-in substances, as set out in Article 3(30) of Regulation (EC) No 1907/2006, shall continue to apply only until 31 December 2019.
2. Once a registrant has completed the registration of a substance, that registrant shall subsequently calculate his quantity of that substance per calendar year in accordance with Article 3(30) of Regulation (EC) No 1907/2006.
Registration requirements for certain low volume phase-in substances
The expiry of the transitional regime for phase-in substances in Regulation (EC) No 1907/2006 shall not affect the applicability of Article 12(1)(b) of that Regulation.
Data-sharing obligations after registration
After registering a substance, registrants, including those who jointly submit data with other registrants, shall continue to fulfil their data-sharing obligations in a fair, transparent and non-discriminatory way as specified in Title III of Regulation (EC) No 1907/2006 and in Implementing Regulation (EU) 2016/9. In that context, registrants may use informal communication platforms similar to the substance information exchange fora referred to in Article 29 of Regulation (EC) 1907/2006.
Duty to inquire and sharing of data for phase-in substances
1. Where data-sharing negotiations conducted in accordance with Article 30 of Regulation (EC) No 1907/2006 result in failure to reach an agreement, the provisions of that Article shall apply only until 31 December 2019.
2. After 31 December 2019, pre-registrations made in accordance with Article 28 of Regulation (EC) No 1907/2006 shall no longer be valid and Articles 26 and 27 shall apply to all phase-in substances.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.