EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council  
as regards the use of Methyl -N-methylanthranilate in cosmetic products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council  
as regards the use of Methyl -N-methylanthranilate in 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 products1, and in particular Article 31(1)  thereof,  
Whereas:  
(1) The substance Methyl -N-methylanthranilate  (M-N-MA)  (CAS No. 85-91-6) is a 
fragrance ingredient used in various cosmetics, including fine fragrances, shampoos, 
soaps and other toiletries. M-N-MA is currently not subject to any prohibition or 
restriction pursuant to Regulation (EC) No 1223/2009 .  
(2) The Scientific Committee on Consum er Safety (SC CS) concluded in an opinion   
adopted at its plenary  meeting of 13 -14 December 20112 that there were  no safety 
concerns for use of M-N-MA in a concentration of up to 0,2 % in rinse -off products. It 
further noted that  M-N-MA is phototoxic , which was the toxicological endpoint of 
concern  in th at opinion . Whilst up to 0 ,1 % M-N-MA may be safe for use in many 
leave -on cosmetic products, the SCCS found that a risk cannot be excluded  for the use 
of that substance in sunscreen  or sun care produc ts or products (including fragrances) 
intended for use on areas exposed to light.  More over, the SCCS concluded  that since 
M-N-MA is prone to nitrosation , it should not be used in combination with nitrosating 
agents and the nitrosamine content  in cosmetic product should be below 50 μg/kg .  
(3) At the plenary meeting of 13 -14 December 2011, the SCCS  also adopted another 
opinion on nitrosamines and secondary amines3. In that opinion, the SCCS concluded 
that the secondary amine s should not be in contact  with adventitious nitrosating agents 
such as nitrite treated raw material containers . That opinion applies also to M -N-MA, 
which is a secondary amine . 
(4) Subsequently, SCCS has concluded , in a scientific advice  of 16 October 2020  on the 
SCCS opinion o n M-N-MA4, that M-N-MA should not  be used in sunscreen products 
and products marketed for exposure to natural  or artificial UV light. For other 
cosmetic products, SCCS  considered  the use of M -N-MA safe in a concentration  of up 
to 0,1 % for leave -on products and 0 ,2 % for rinse -off products.  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety, Opinion on methyl -N-methylanthranilate, 13 -14 
December 2011 (SCCS/1455/11) . 
3 SCCS (Scientific Committee on Consumer Safety) Opinion on Nitrosamines and Secondary Amines in 
Cosmetic Products, 13 -14 December 2011 (SCCS/1458/11) . 
4 Scientific advice on the SCCS Opinion on methyl N-methylanthranilate (MNM) (SCCS/1455/11), 16 
October 2020  (SCCS/1616/20 ). EN 2  EN (5) In light of the SCCS opinion s and scientific advice, there is a potential risk to human 
health arising from the use of M -N-MA in sunscreen products  and products marketed 
for exposure to natural or artificial UV li ght and in other cosmetic products where the 
concentration of the substance is more than 0,1 % for leave -on products and 0 ,2 % for 
rinse -off products . Therefore, such use of M -N-MA should be prohibited.  
(6) In light of the SCCS opinions and scientific advice, there is also a potential risk to 
human health arising from  the use of M-N-MA with nitrosating agents . Therefore, 
such use of M -N-MA should be prohibited , a maximum nitrosamine content in the 
cosmetic product of 50 μg/ kg should be set and a requirement to keep cosmetic 
products containing M -N-MA in nitrite -free containers  should be introduced .  
(7) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(8) The industry should be allowed a reasonable period of time to adapt to the new 
requirements  by making the adjustments to product formulations and containers that 
are necessary to ensure that only cosmetic products complying with the new 
requirements are placed on the market. The industry should also be allowed a 
reasonable period of time to withdraw  cosmetic products which do not comply with 
the new requirements from the market.   
(9) The measures provided for in this Regulation are in acc ordance with the opinion of the  
Standing Committee on Cosmetic Products,   
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex  III 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 R egulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen