Future update of Annex XIV entries of four phthalates: some uses previously exempted may require authorisation
Public consultation on behalf of the Commission
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) 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.
Consequently, the Commission is preparing to amend the Authorisation List with the additional intrinsic properties of these four substances.
This update means that some uses which until now have been exempted may require authorisation, such as:
- uses of the four phthalates in mixtures in concentrations 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 relevant document; exemptions listed in section 1 still apply) due to the endocrine disrupting effects on the environment of DEHP.
More detailed information can be found in the Explanatory note by the European Commission.
In preparation for this update, the Commission invites comments on the proposed transitional arrangements, in particular from those actors affected by the change in authorisation requirements, i.e. those who may need to apply for authorisation (unless phase-out of the substance before the newly set sunset date is possible).
In addition, comments (including reasons) are invited on uses which should be exempted and on uses for which review periods should be set. Since the substances are already included in Annex XIV, comments regarding the inclusion of the substances in Annex XIV will not be considered.
The documents General approach for preparation of draft Annex XIV entries for substances to be included in Annex XIV and ECHA's general responses on issues commonly raised in public consultations on draft recommendations (sections B and C) provide background on what kind of information is considered when specifying Annex XIV entries. However, ECHA is not preparing an Annex XIV recommendation for the Annex XIV entries’ update consulted on here.
Please note that this public consultation does not concern uses which are already subject to authorisation and for which an authorisation decision has been adopted, is pending or under review. The Commission will examine these uses separately, i.e. they are not part of this consultation.
ECHA will pass on all submissions received directly to the Commission for consideration when preparing the Annex XIV amendment. Any direct inquiries should be sent to GROW-ENV-REACH-AUTH@ec.europa.eu
Consultations close at 23:59 Helsinki time.
- Explanatory note by the European Commission [PDF][EN]
- Draft Annex XIV entries for the four phthalates [PDF][EN]
- General approach for preparation of draft Annex XIV entries for substances to be included in Annex XIV [PDF][EN]
- Generic exemptions from the authorisation requirement [PDF][EN]
- ECHA's general responses on issues commonly raised in public consultations on draft recommendations [PDF][EN]
- Authorisation List