EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
[…](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amendin g Annex V to Re gulation (EC) No 1223/2009 of the European Parliament and of 
the Council on cosmetic products 
(Text with EEA relevance) 
  
EN 1   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex V 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(1) thereof, 
Whereas: 
(1) The mixture of Methylchloroisot hiazolinone and Methylisothiazolinone2 with 
magnesium chloride and magnesium nitrate is  currently allowed as a preservative in 
all cosmetic products at a maximum con centration of 0,0015 % of a mixture in the 
ratio 3:1 of Methylchloroisothiazolinone and Methylisothiazolinone respectively. 
(2) The Scientific Committee on Consumer Safe ty ("SCCS") adopted an opinion on the 
safety of the mixture Methylchloroisot hiazolinone and Methylisothiazolinone on 8 
December 20093. 
(3) The SCCS concluded that the mixture of Methylchloroisothiazolinone and 
Methylisothiazolinone in a ratio of 3:1 doe s not pose a risk to the health of the 
consumer when used as a preservative up to  a maximum authorised concentration of 
0,0015 % in rinse-off cosmetic products, apart from its skin sensitising potential. The 
SCCS indicated that induction and elicita tion would be less likely in a rinse-off 
product than when the same concentra tion is present in a leave-on product. 
(4) The issue of stabilizers for that mixture was addressed by the Scientific Committee on 
Cosmetic Products and Non-Food Products  intended for Consumers ("SCCNPF"), 
subsequently replaced by the Scientific Committee on Consumer Products ("SCCP"), 
pursuant to Commissi on Decision 2004/210/EC4, subsequently replaced by the SCCS, 
pursuant to Commissi on Decision 2008/721/EC5, in an opinion of 24-25 June 20036. 
The Committee stated that, taking into acc ount that the active ingredients and their 
ratio remain unchanged in current commerc ialised cosmetic products and that the 
concentration of the stabiliser system in th e finished cosmetic products is negligible, 
the replacement of magnesium chloride and magnesium nitrate by copper sulphate or 
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 For translators: please do not transl ate the parts highlighted in yellow! 
3 SCCS/1238/09. 
4 Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of 
consumer safety, public health and the environment (OJ L 66, 4.3.2004, p. 45). 
5 Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific 
Committees and experts in the field of consumer safety, public health and the environment and 
repealing Decision 2004/210/EC (OJ L 241, 10.9.2008, p. 21). 
6 SCCNFP/0670/03, final.  
EN 2   EN any other authorised cosmetic ingredient as  a stabiliser system in the mixture of 
Methylchloroisothiazolinone and Met hylisothiazolinone doe s not alter the 
toxicological profile of that  mixture. When requested by the Commission to clarify the 
interpretation of the word "authorised", the Committee replied, in an opinion of 7 December 2004
7, that the expression “authorised cosmetic ingredient” should be 
interpreted as “any ingredient which, in the light of the Cosmetics Directive8, is 
allowed or not prohibited and may be used in cosmetic products, provided that any 
substance belonging to the cl asses of ingredients list ed in the Annexes III-VII9 of the 
Directive may be used only if it is include d in the respective a nnex.” In addition, the 
conclusion of the SCCS opinion of 8 Dece mber 2009 contains an assessment of the 
safety of the mixture itself and makes no reference to the stabilisers taken into consideration.  
(5) In light of the SCCS opinion mentioned above, the Commission considers that, in 
order to avoid a potential risk to huma n health, the use of the mixture of 
Methylchloroisothiazolinone and Methylis othiazolinone should be restricted as 
recommended by the SCCS, while the referenc e to the stabilisers magnesium chloride 
and magnesium nitrate should be deleted from its chemical name. 
(6) It should be clarified that the use of th e mixture of Methylch loroisothiazolinone and 
Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in 
the same product, as it would alter th e ratio 3:1 allowed for the mixture10. 
(7) Regulation (EC) No 1223/2009 should therefore be amended accordingly. 
(8) The application of the above-mentioned rest rictions should be deferred to allow the 
industry to make the necessary adjustment s to product formulations. In particular, 
undertakings should be gran ted nine months to place on the market compliant 
products, and eighteen months to withdraw from the market non- compliant products 
after the entry into for ce of this Regulation.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this 
Regulation. 
Article 2 
  
                                                 
7 SCCP/0849/04. 
8 Council Directive of 27 July 1976 on the approxima tion of the laws of the Member States relating to 
cosmetic products (76/768/EEC) (OJ L 262, 27.9.1976, p. 169). 
9 The Commission assumes that the SCCP wanted to refer to the substances functioning as colorants, 
preservatives or UV-filter, which need to be explicitly  authorized by being listed in Annexes IV, VI and 
VII to Directive 76/768/EEC. Those three Annexes should therefore be mentioned, and not "Annexes 
III-VII". 
10 This is in line with the SCCS’s opinion on Methylisothiazolinone of 12 December 2013 
(SCCS/1521/13) which clearly states that Methylisothi azolinone should not be us ed as an addition to a 
cosmetic product already containing the mixture Methylchloroisothiazolinone and 
Methylisothiazolinone.  
EN 3   EN From (please insert date – nine months after en try into force of this Regulation) only cosmetic 
products which comply with Regulation (EC)  No 1223/2009 as amended by this Regulation 
shall be placed on the Union market. 
From (please insert date – eighteen months af ter entry into force of this Regulation) only 
cosmetic products which comply with Regulation (EC) No 1223/2009 as amended by this Regulation shall be made avai lable on the Union market. 
Article 3 
 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from (please insert date – nine mo nths after entry into fo rce of this Regulation). 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  José Manuel BARROSO