• April 23, 2020
  • WTO

Draft Commission Regulation amending Annex XVII of REACH, as regards CMR substances, medical devices, persistent organic pollutants, certain liquid substances/mixtures



Title of document
Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocol

Description
In the first place, this draft Commission Regulation aims to include within the scope of entries 28 to 30 of Annex XVII to Regulation (EC) No 1907/2006 several substances, with the effect of restricting their placing on the market or use for supply to the general public as substances on their own, as constituents of other substances or in mixtures and to impose the requirement to mark packaging with the label "restricted to professional users". This is consequent on the recent classification of these substances as CMR category 1A or 1B under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, as amended by Commission Regulation (EU) 2018/1480 and Commission Delegated Regulation (EU) 2020/217. Moreover, this draft Commission Regulation aims to: delete three entries from Annex XVII to the REACH Regulation, as the substances concerned have been, or are about to be, incorporated into Regulation 2019/2012 on persistent organic pollutants; include an exemption, from the aforementioned entries 28 to 30, for devices covered by Regulation (EU) 2017/745 on medical devices; delete an obsolete paragraph mandating a review of the restriction on liquid substances or mixtures; delete obsolete references to “R phrases” from the restriction on liquid substances or mixtures; delete obsolete references to CMR classifications under Directive 67/548 from the titles of Appendixes 1-6 of Annex XVII; update the references to testing methods for azocolourants in Appendix 10 of Annex XVII, to reflect technical progress; and finally delete the CAS and EC numbers from entry 46 of Annex XVII, as their inclusion, in 2009, inadvertently reduced the scope of this entry, and the original intention of the legislator should be reflected again.

Notifying member: European Union

NotificationG/TBT/N/EU/714

Objective tag
Protection of human health or safety; Other

Objective
The abovementioned substances recently received new harmonised classifications as CMR category 1A or 1B. In accordance with Article 68(2) of Regulation (EC) 1907/2006 (REACH), the Commission may propose a restriction on the use of these substances and mixtures containing them by consumers. The other proposed changes aim to increase legal clarity and consistency, facilitate implementation and/or avoid double regulation.

Documents


Agency responsible
European Commission


Timing:

  • Submission: 22/04/2020
  • Reception: 23/04/2020
  • Distribution: 23/04/2020
  • Final date for comments: 22/06/2020
  • Proposed date of adoption: N/A

                   

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