G/TBT/N/EU/760  
24 November 2020  
(20-8484) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/e n/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Chemical 
substances; Products of the chemical industry (ICS 71.100)  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Regulation amending Annex XIV to Regulation (EU) No 1907/2006 of the 
European Parliament and of the C ouncil concerning the Registration, Evaluation, 
Authorisation and Restriction of Chemicals (REACH) (5 page(s), in English; 4 page(s), in 
English)  
6. Description of content:  This draft Commission Regulation aims at amending Annex XIV 
of the REACH Regulatio n. 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 endo crine 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.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this draft Regulation is to include the endoc rine 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 G/TBT/N/EU/760  
 
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  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 ap plication 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 authorisat ion requirement for the use of the four substances in 
immediate packaging will no longer apply.  
Protection of human health or safety; Other  
8. Relevant documents:   
• Regulation (EC) No 1907/2006 of the European Parliament and of the Council on 
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 
(OJ L 396, 30.12.2006, p. 1)  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32006R1907&qid=1606121951237  
• Regulation as last amended by Commission Regulation (EU) 2020/11 49 of 
3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 as regards 
diisocyanates (OJ L 252, 4.8.2020, p.24)  
https://eur -lex.europa.eu/ legal-
content/EN/TXT/?uri=CELEX%3A32020R1149&qid=1606122051349  
• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws 
of the Member States relating to active implantable medical devices (OJ L 189, 
20.7.1990, p. 17).  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A31990L0385&qid=1606122296839  
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 
L 169, 12.7.1993, p. 1).  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A31993L0042&qid=1606122367928  
• Directive 98/79/EC of the European Parl iament and of the Council of 27 October 
1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).  
https://eur -lex.europa.eu/legal -
conte nt/EN/TXT/?uri=CELEX%3A31998L0079&qid=1606122402458  
• Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 
27 October 2004 on materials and articles intended to come into contact with 
food and repealing Directives 80/590/EEC and 89/1 09/EEC, (OJ L 338, 
13.11.2004, p. 4).  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A32004R1935&qid=1606122440374  
9. Proposed date of adoption:  February 2021  
Proposed date of entry into force:  20 days after publication in the Official Journal of 
the European Union  G/TBT/N/EU/760  
 
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  10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website: http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.w to.org/crnattachments/2020/TBT/EEC/20_7250_00_e.pdf  
https://members.wto.org/crnattachments/2020/TBT/EEC/20_7250_01_e.pdf