Commission Regulation (EU) 2020/1684 of 12 November 2020 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)
Date: 2020-11-12
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical product, consumer information, cosmetic product, health control, health risk, market approval, product safety








L_2020379EN.01004201.xml










13.11.2020   


EN


Official Journal of the European Union


L 379/42








            COMMISSION REGULATION (EU) 2020/1684
of 12 November 2020
         
amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31(2) thereof,

Whereas:







(1)


The Scientific Committee on Consumer Safety (SCCS) concluded in its opinion of 13 December 2019 (2) (‘the SCCS opinion’) that the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate as a UV filter in cosmetic products at a maximum concentration of 3 % is safe. Inhalation toxicity was not assessed in the SCCS opinion because no data were provided. Hence, the SCCS opinion is not applicable to any cosmetic product in form of spray that could lead to exposure of the end-user’s lungs by inhalation.












(2)


The SCCS also concluded in its opinion that Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate is a secondary amine, and thus is prone to nitrosation and formation of nitrosamine. It should not be used in combination with nitrosating substances. The nitrosamine content should be less than 50 ppb.












(3)


In light of the SCCS opinion and in order to take into account technical and scientific progress, the use of Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate as a UV filter in cosmetic products should be authorised at a maximum concentration of 3 %, except in applications that may lead to exposure of the end-user’s lungs by inhalation.












(4)


Annex VI to Regulation (EC) No 1223/2009 should therefore be amended accordingly.












(5)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,





HAS ADOPTED THIS REGULATION:



Article 1
Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 November 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 342, 22.12.2009, p. 59.

(2)  SCCS/1605/19.




ANNEX
In Annex VI to Regulation (EC) No 1223/2009, the following entry is added:














Reference number


Substance identification


Conditions


Wording of conditions of use and warnings




Chemical name/INN/XAN


Name of Common Ingredients Glossary


CAS number


EC number


Product type, Body parts


Maximum concentration in ready for use preparation


Other




a


b


c


d


e


f


g


h


i




‘32


2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate


Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate


1419401-88-9


700-860-3


 


3 %








—


Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation










—


Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg










—


Keep in nitrite-free containers’