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 th e European Parliament and of 
the Council on cosmetic products 
(Text with EEA relevance) 
  
EN 2   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)
 Entry 25 of Annex V to Regulation (EC) No 1223/2009 specifies a maximum 
concentration of 0,3% in relation to the use of triclosan as a preservative in cosmetic 
products. 
(2) The Scientific Committee on Consumer Produc ts ("SCCP"), subsequently replaced 
by the Scientific Committee on Consumer Sa fety ("SCCS") pursuant to Commission 
Decision 2008/721/EC2, adopted an opinion on the safety of triclosan for human 
health in January 20093, followed by an addendum of March 20114. 
(3) The SCCP considered that the continued us e of triclosan as a preservative at the 
current maximum concentration limit of 0,3% in all cosmetic products is not safe for 
the consumer because of the magnitude of  the aggregate exposure, and the SCCS 
confirmed this position. However, the SCCP  considered that its use at a maximum 
concentration of 0,3% in toothpastes, hand soaps, body soaps/shower gels and 
deodorant sticks, face powders and blemish c oncealers is safe. In addition, the SCCS 
considered that other uses of  triclosan in nail products wh ere the intended use is to 
clean the fingernails and toenails, with a maximum frequency of every two weeks, at 
a maximum concentration of 0,3 % and in mouthwashes at a maximum concentration 
of 0,2 % are safe for the consumer. 
(4) In light of the SCCS opinions menti oned above, the Commission considers that 
maintaining the restriction on the use of triclosan at its current level would raise a potential risk to human hea lth. The additional restrictions  suggested by the SCCP and 
the SCCS should therefore be implemente d in Annex V to Re gulation (EC) No 
1223/2009. 
(5)
 Entry 12 of Annex V to Regulation (EC) No 1223/2009 specifies a maximum 
concentration of 0,4 % for sing le ester and 0,8 % for mixtures  of esters in relation to 
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 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). 
3 SCCP/1192/08, http://ec.europa.eu/health/ph_ risk/committees/04_sccp/docs/sccp_o_166.pdf. 
4 SCCS/1414/11,http://ec.europa.eu/ health/scientific_committees/consum er_safety/docs/sccs_o_054.pdf.  
EN 3   EN the use of parabens as preservatives in cosmetic products, under the denomination 4-
hydroxybenzoic acid and its  salts and esters. 
(6) The SCCS adopted an opinion on parabens in December 20105, followed by a 
clarification of  October 20116 in response to a unilateral decision by Denmark to ban 
propylparaben and butylparaben, their isofor ms and their salts in cosmetic products 
for children under three years of age base d on their potential endocrine activity, 
taken in accordance with Article  12 of Council Directive 76/768/EEC7. 
(7) The SCCS confirmed that methylparaben an d ethylparaben are sa fe at the maximum 
authorized concentrations. In addition, th e SCCS noted that limited or no information 
was submitted by industry for the safe ty evaluation of isopropylparaben, 
isobutylparaben, phenylparaben, benzylparabe n and pentylparaben. As a result, for 
these compounds, the human risk cannot be ev aluated. Therefore, those substances 
should no longer be listed in Annex V and, given that thei r only function is that of 
preservatives, they should not be used in cosmetic products. 
(8) The conclusions the SCCS drew in the same opinions on propylparaben and 
butylparaben were challenged by a study carried out by the French authorities8, 
therefore a further risk assessment of thos e two substances was adopted by the SCCS 
in May 20139. Measures on propylparaben and but ylparaben are under preparation, 
as a second step in the risk management of parabens. 
(9) No concerns were raised on the safety  of 4-Hydroxybenzoic acid and its salts 
(calcium paraben, sodium pa raben, potassium paraben).  
(10) The relevant annex to Regulation (EC) No 1223/2009 should therefore be amended 
accordingly. 
(11) The application of the above-mentioned restri ctions should be deferred to allow the 
industry to make the necessary adjustment s to product formulations. In particular, 
undertakings should be granted six months  to place on the market compliant 
products, and fifteen months to stop maki ng available on the market non-compliant 
products after the entry into force of this Re gulation, in order to allow existing stocks 
to be exhausted.  
(12) The measures provided for in this Regulat ion are in accordance with the opinion of 
the Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to 
this Regulation. 
                                                 
5 SCCS/1348/10 Revision 22 March 2011. 
6 SCCS/1446/11. 
7 OJ L 262, 27.9.1976, p. 169. 
8 Gazin V., Marsden E., Briffaux J-P (2012), Propylparaben: 8-week postweaning juvenile toxicity study 
with 26-week treatment free period in male Wistar ra t by the oral route (gav age) Poster SOT Annual 
Meeting San Francisco USA - Abstract ID 2359*327. 
9 SCCS/1514/13.  
EN 4   EN Article 2 
From (please insert date – six months after entr y into force of this Regulation) only cosmetic 
products which comply with this Regulat ion shall be placed on the Union market. 
From (please insert date – fifteen months af ter entry into force of this Regulation) only 
cosmetic products which comply with this Regulation shall be made available 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 . 
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  
EN 5   EN ANNEX  
 Annex V is amended as follows: 
(a) entry 12 is replaced by the following: 
  Substance Identification Conditions   
Reference 
number Chemical name/INN Name of Common 
Ingredients 
Glossary CAS number EC 
number Product type, 
Body parts Maximum 
concentration 
in ready for 
use 
preparation Other Wording 
of 
conditions 
of use and 
warnings 
a b c d e f g h i 
"12 4-Hydroxybenzoic 
acid and its salts and esters, other than the 
esters of isopropyl, 
isobutyl, phenyl, 
benzyl and pentyl  4-Hydroxybenzoic 
acid 
 
methylparaben 
 
butylparaben 
 
potassium 
ethylparaben 
 
potassium paraben 
 
propylparaben 
 
sodium 99-96-7 
  99-76-3  94-26-8   
36457-19-9 
 16782-08-4  94-13-3   202-804-9 
  202-785-7   202-318-7   
253-048-1 
 240-830-2  202-307-7    0,4 % (as 
acid) for single ester, 0,8 % (as acid) for mixtures of esters"   
                                                 
10 For translators: please do not translate these names!  
EN 6   EN methylparaben 
 
sodium 
ethylparaben 
 
sodium 
propylparaben 
 
sodium 
butylparaben 
 
ethylparaben 
 
sodium paraben 
 
potassium 
methylparaben 
 
potassium 
butylparaben 
 
potassium 
propylparaben  
 
sodium 
propylparaben 
 
calcium paraben10 
 5026-62-0 
  35285-68-8   35285-69-9   36457-20-2  120-47-8  114-63-6   26112-07-2  
 
38566-94-8   84930-16-5   35285-69-9  69959-44-0  225-714-1 
  252-487-6   252-488-1   253-049-7  204-399-4  204-051-1   247-464-2  
 
254-009-1   284-597-5   252-488-1  274-235-4  
 
(b) entry 25 is replaced by the following:  
EN 7   EN   Substance Identification Conditions   
Reference 
number Chemical name/INN Name of Common 
Ingredients 
Glossary CAS number EC 
number Product type, 
Body parts Maximum 
concentration 
in ready for 
use 
preparation Other Wording 
of 
conditions 
of use and 
warnings 
a b c d e f g h i 
"25 5-Chloro-2- (2,4- 
dichlorophenoxy) 
phenol Triclosan11 3380-34-5 222-182-2 (a) Toothpastes  
Hand soaps  Body 
soaps/Shower gels 
Deodorants (non-
spray) 
Face powders and 
blemish concealers 
Nail products for 
cleaning the 
fingernails and toenails  
(b) Mouthwashes (a) 0,3 % 
          
(b) 0,2 %" For the 
nail products for cleaning the fingernails and toenails, the maximu
m 
frequency of use should be every two weeks.  
 
                                                 
11 For translators: please do not translate this name!