EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex III to Regula tion (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)  …/.. 
of XXX  
amending Annex III 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) Zinc Pyrithione is authorised as a preserva tive in rinse-off hair products at a maximum 
concentration of 1,0 % and in other rinse- off cosmetic products at 0,5 % (excluding 
oral products) in entry 8 of Annex V to Regulation (EC) No 1223/2009. Zinc 
Pyrithione is also regulated in entry 101 of Annex III to Regulation (EC) No 
1223/2009 for purposes other than inhibiting th e development of micro-organisms in 
leave-on hair products at a maximum concentration of 0,1 %.  
(2) In 2000, the Scientific Committee on Cosm etic Products and Non-Food Products 
intended for Consumers (SCCNFP) was request ed to review the safety of Zinc 
Pyrithione in its function as a non-pres ervative. On 17 December 2002 the SCCNFP 
adopted an opinion2 concluding the safe use of Zinc  Pyrithione for non-preservative 
purposes in cosmetic rinse-off and leav e-on hair care products at a maximum 
concentration of 1,0 % and 0,1 % respectively. The opinion also concluded that Zinc 
Pyrithione should not be used in products for oral hygiene.  
(3) In 2008, the Scientific Committee on Consumer Safety (SCCS) was requested to 
evaluate an extension of the maximum con centration from 1,0 % to 2,0 % in rinse-off 
anti-dandruff hair care products.  
(4) On 18 June 2013 the SCCS adopted an opinion, later revised on 18 June 20143, 
concluding on the safety of Zi nc Pyrithione when used at  a concentration up to 2,0 % 
as an anti-dandruff agent in rinse-off hair care products.  
(5) In light of the opinions mentioned above, Zi nc Pyrithione should be authorised in 
rinse-off anti-dandruff hair products at a maximum concentration of 2,0 % for non-
preservative purposes.  
(6) Regulation (EC) No 1223/2009 should th erefore be amended accordingly.  
(7) The measures provided for in this Regula tion are in accordance with the opinion of 
the Standing Committee on Cosmetic Products,  
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 SCCNFP/0671/03 
3 SCCS/1512/13: http://ec.europa.eu/health/scientific_commi ttees/consumer_safety/ docs/sccs_o_133.pdf  EN 3   EN  
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex III to Regulation (EC) No 1223/2009 is ame nded in accordance with the Annex to this 
Regulation. 
Article 2 
This Regulation shall enter into  force on the twentieth day follo wing 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  Jean-Claude Juncker