COMMISSION IMPLEMENTING REGULATION (EU) …/...
of XXX
on the application of certain registration and data-sharing provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council after the expiry of the final registration deadline for phase-in substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 1 , and in particular Article 132 thereof,
Whereas:
(1)In order to avoid overloading authorities and natural or legal persons with the work arising from the registration of substances that were already on the internal market when Regulation (EC) No 1907/2006 entered into force, Article 23 of that Regulation established a transitional regime for phase-in substances. Consequently, a number of different transitional deadlines for the registration of such substances were laid down. It follows from Article 23(3) of that Regulation that the final registration deadline in that transitional regime expired on 1 June 2018.
(2)In order to ensure equality between market operators manufacturing or placing on the market phase-in and non-phase-in substances, it is necessary to specify the applicability, after the expiry of the transitional regime, of provisions that laid down favourable conditions for the registration of phase-in substances. Therefore, for those provisions, an appropriate, reasonable and clear cut-off date should be set, after which those provisions should either no longer apply or only apply in specific circumstances. To take into account the definition of "per year" in Article 3(30) of Regulation (EC) No 1907/2006 while also ensuring that market operators have enough time to adapt, it is appropriate to set the cut-off date at the end of this calendar year (31/12/2019).
(3)Article 3(30) of Regulation (EC) No 1907/2006 sets conditions for the calculation of the quantities per year of phase-in substances based on the average production or import volumes for the three preceding calendar years. In order to ensure that market operators have sufficient time to make the necessary adjustments to their calculation methods, those conditions should, as a first measure, continue to apply until the specified cut-off date.
(4)In order to reduce the possible impact of registration obligations on low volume substances, Article 12(1)(b) of Regulation (EC) No 1907/2006 lays down less stringent information requirements for the registration of certain low volume phase-in substances. The deadline for registration of those low volume phase-in substances expired on 1 June 2018, but new toxicological and ecotoxicological information on substances in the lowest tonnage band between 1 and 10 tonnes should only be submitted for priority substances in that tonnage band. In order to put Article 12(1)(b) efficiently into effect, that provision should therefore, as a second measure, continue to apply after 1 June 2018.
(5)On 1 June 2018, the formal operation of substance information exchange fora (SIEFs) ceased. However, as a third measure, the continuing data-sharing obligations of registrants should be reinforced and registrants should be encouraged to use similar informal communication platforms to enable them to meet their continuing registration and data-sharing obligations under both Regulation (EC) No 1907/2006 and Commission Implementing Regulation (EU) 2016/9 2 .
(6)It is appropriate to set out, as a fourth measure, that a potential registrant who pre-registered a phase-in substance in accordance with Article 28 of Regulation (EC) No 1907/2006 should, until the specified cut-off date, not be required to follow the inquiry process set out in Article 26 of that Regulation because the objective of the inquiry process has already been fulfilled through the pre-registration.
(7)It is necessary to ensure that data-sharing dispute processes are clearly identifiable. The data-sharing rules set out in Article 30 of Regulation (EC) No 1907/2006 should therefore continue to apply until the specified cut-off date. After that cut-off date, only the data-sharing rules in Articles 26 and 27 of that Regulation should apply.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Article 1
Calculation of quantities of phase-in substances