Public consultation on a draft recommendation for amendment of Authorisation List entries


The four phthalates bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) were identified as substances of very high concern (SVHCs) due to their classification as toxic for reproduction and added to the Candidate List in 2008 and 2010. Following ECHA’s recommendations these substances were included in the Authorisation List (Annex XIV to REACH) in 2011 and 2012 (entries 4 to 7).

After inclusion in the Authorisation List, these four substances were additionally identified as having endocrine disrupting properties with effects on human health and, in the case of DEHP, also on the environment. The Candidate List was updated accordingly in 2014 and 2017.

The Commission is currently considering the inclusion of the above-mentioned Article 57(f) properties into the respective entries of these four substances in the Authorisation List. Therefore ECHA has prepared a draft recommendation in accordance with Articles 58(3) and (4) of REACH.

This amendment will mean that some uses which until now have been exempted may require authorisation, such as: uses of the four phthalates in mixtures in concentrations equal or above 0.1 % w/w (so far the concentration limit has been 0.3 % w/w); some uses of DEHP (e.g. in food contact materials or medical devices) that will no longer fall under the ‘generic exemptions from the authorisation requirement’ (see section 2 of the document; exemptions listed in section 1 still apply) due to the endocrine disrupting effects on the environment of DEHP.

Please note that ECHA had already hosted a public consultation on behalf of the Commission on this issue, which ran from 5 June 2018 to 6 August 2018. Comments submitted during that previous consultation will be published on the Commission’s website and will be considered for ECHA’s recommendation on the amendment of Annex XIV.

For more information please visit ECHA's website and please note that consultations close on the 12th March 2019 at 23:59 Helsinki time.