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Consultation on four phthalates for updating their Authorisation List entries with endocrine disrupting properties


The European Commission is preparing to amend the Authorisation List (Annex XIV to REACH) entries owing to the additional identification of the four phthalates as substances of very high concern (SVHCs) with endocrine disrupting effects on human health or the environment. Consequently, some uses previously exempted may require authorisation.

Helsinki, 5 June 2018 – In 2014 and 2017 the four phthalates bis(2-ethylhexyl) phthalate (DEHP, EC 204-211-0, CAS 117-81-7), dibutyl phthalate (DBP, EC 201-557-4, CAS 84-74-2), benzyl butyl phthalate (BBP, EC 201-622-7, CAS 85-68-7) and diisobutyl phthalate (DIBP, EC 201-553-2, CAS 84-69-5) were identified as substances of very high concern (SVHCs) for authorisation due to endocrine disrupting properties with effects on human health and, in the case of DEHP, also on the environment. The Candidate List entries for these substances were updated accordingly.

The four phthalates had earlier been identified as SVHCs and subsequently added to the Authorisation List in 2011 and 2012 due to their classification as toxic for reproduction.

Later this year, the European Commission intends to amend the current entries of these substances in the Authorisation List to also include the endocrine disrupting properties as intrinsic properties referred to in Article 57.

ECHA, on behalf of the Commission, is now launching a public consultation targeted at the sectors affected by such amendment of the Authorisation List. In particular, information is sought about the uses that might no longer be covered by generic exemptions from the authorisation requirement, such as uses in food contact materials and in medical devices, as well as transitional arrangements, exemptions and review periods.

Uses already subject to authorisation will be examined separately by the Commission.

The deadline for providing comments is 6 August 2018.