EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2013) XXX  draft 
  
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) 
  
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) Parabens are regulated as preservatives in entry 12 of Annex V to  Regulation (EC) No 
1223/2009 on cosmetic products under the denomination 4-hydroxybenzoic acid and 
its salts and esters, with a maximum concen tration of 0,4 % for si ngle ester and 0,8 % 
for mixtures of esters. 
(2) The Scientific Committee on Consumer Safe ty ("SCCS"), established pursuant to 
Commission Decision 2008/721/EC
2, adopted an opinion on parabens in December 
20103. This opinion was followed by a clarification of October 20114 in response to a 
unilateral decision by Denmark to ban propylparaben and butylparaben, their isoforms 
and their salts in cosmetic products for children under three years of age based on 
those substances’ potential endocrine activ ity, taken in accordance with Article 12 of 
Council Directive 76/768/EEC5. The conclusions of 2010 and 2011 were confirmed by 
the SCCS in an additi onal opinion of May 20136, which the Commission had 
requested in light of a new study on the reprotoxicity of propylparaben. 
(3) In the above-mentioned opinions, which c oncerned all the long-chain parabens, the 
SCCS confirmed that methylparaben and ethylparaben are safe at the maximum 
authorized concentrations.  
(4) Isopropylparaben, isobutylparaben, phenylpa raben, benzylparaben and pentylparaben 
were banned by Commission Regulation XXX/20137 (not yet adopted). 
(5) The SCCS concluded that the use of butylpa raben and propylparaben  as preservatives 
in finished cosmetic products is safe to the consumer, as long as the sum of their 
individual concentrations does not exceed 0,19 % (as esters). 
(6) For general cosmetic products containing butylparaben and pr opylparaben, excluding 
specific products for the nappy area, the S CCS concluded that there was no safety 
                                                 
1 OJ L 342, 22.12.2009, p. 59 
2 OJ L 241, 10.9.2008, p. 21. 
3 SCCS/1348/10 Revision 22 March 2011. 
4 SCCS/1446/11. 
5 OJ L 262, 27.9.1976, p. 169. 
6 SCCS/1514/13. 
7 OJ L …  
EN 2   EN concern for children of any age group as the margin of safety was based on very 
conservative assumptions, with regard s to both toxicity and exposure. 
(7) However, the SCCS maintained that concerning butylparabe n and propylparaben 
present in leave-on cosmetic  products designed for applic ation on the nappy area of 
children below the age of six months, a risk could not be excluded in the light of both 
immature metabolism of such children and the possibility of damaged skin in the 
nappy area. Based on a worst case assumption of exposure, safety concerns might be 
raised. 
(8) No concerns were raised on the safety of 4-Hydroxybenzoic acid and its salts (calcium 
paraben, sodium paraben, potassium paraben). 
(9) The Commission considers that  the continued use of but ylparaben and propylparaben 
under the current conditions may constitute a potential risk for human health. It therefore considers that the conditions fo r their use should be  aligned with the 
recommendations of the SCCS.  
(10) For reasons of consistency with the current  entry 12 of Annex V to Regulation (EC) 
No 1223/2009, the recommended maximum concen tration of 0,19 % as esters for the 
substances listed in entry 12a should be conve rted to be expressed into its equivalent 
as acid, 0,14 %. In addition, the sodium  and potassium salts of butyl and 
propylparabens should be submitted to the same conditions of use as butyl and 
propylparabens themselves, given that the S CCS never reported a different behaviour 
(in the chemistry or toxicity) of  the salts compared to the esters in any of its previous 
opinions. 
(11) In the absence of any indi cation to the contrary from the SCCS, the maximum 
concentration of 0,8% for the sum of a ll parabens contained a cosmetic product 
already foreseen by entry 12 of Annex V to Regulation (EC) No 1223/2009 should be 
maintained. 
(12) In light of the concerns raised by the SCCS  regarding the use of parabens in leave-on 
cosmetic products designed for applicati on on the nappy area of children under the age 
of six months, and for practical reasons linke d to the fact that pr oducts for infants are 
usually marketed for children under thr ee years, butylparabe n and propylparaben 
should be prohibited in leave-on cosmetic products designed for application on the 
nappy area of children below three years. 
(13) Regulation (EC) No 1223/2009 should therefore be amended accordingly. 
(14) 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 granted six months to place on the market compliant products, and twelve months to withdraw from th e market non-compliant products after the 
entry into force of this Regulation.  
(15) 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.  
EN 3   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 – twelve 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 . 
It shall apply from (please insert date – six m onths 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