REACH Annex XIV - Authorisation | Draft regulation adding endocrine disrupting properties to existing entries: DEHP, BBP, DBP, DIBP
Title of document
Draft Commission Regulation amending Annex XIV to Regulation (EU) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (5 page(s), in English; 4 page(s), in English)
This draft Commission Regulation aims at amending Annex XIV of the REACH Regulation. Annex XIV lists the substances which are subject to the authorisation requirement laid down in Title VII of the Regulation. The draft proposes to include additional properties to some existing entries in that Annex, namely:
- entry 4 (DEHP): to add endocrine disrupting (ED) properties for the environment;
- entries 4 to 7 (DEHP, BBP, DBP and DIBP): to add ED properties for human health.
Once the Regulation is adopted and enters into force, the placing on the market and the use of those substances in the EU will only be possible, after the date specified for each substance ("sunset date"), for those operators who have been granted an authorisation in accordance with Articles 60-64 of REACH, and for those who have submitted an application for authorisation before a given date ("latest application date") but a decision has not yet been adopted.
Notifying member: European Union
Protection of human health or safety; Other
The objective of this draft Regulation is to include the endocrine disrupting properties to the existing Reprotoxic ones in Annex XIV for these substances.
According to Article 55 of REACH, the aim of the authorisation provisions is "to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable."In accordance with Article 56 of REACH, a manufacturer, importer or downstream user shall not place on the market and/or use a substance listed in Annex XIV of REACH after a given date (“sunset date”) unless that use has been authorised or an application has been submitted before the latest application date (and a decision has not yet been taken), or the use is exempted.
With the inclusion of intrinsic properties relating to hazards for the environment in the entry for DEHP in Annex XIV, the exemptions from the authorisation requirement of uses of that substance in medical devices regulated by Directives 90/385/EEC, 93/42/EEC and 98/79/EC and in food contact materials within the scope of Regulation (EC) No 1935/2004 will no longer apply. In addition, due to the inclusion of ED properties in the entries of DEHP, BBP, DBP and DIBP, the concentration limit applicable to the presence of these substances in mixtures for the purposes of the exemption set out in Article 56(6) will become 0,1% weight by weight. Finally, the exemptions from the authorisation requirement for the use of the four substances in immediate packaging will no longer apply.
- Submission: 23/11/2020
- Reception: 24/11/2020
- Distribution: 24/11/2020
- Final date for comments: 23/01/2021
- Proposed date of adoption: N/A