EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
[…](2017) XXX  draft 
  
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes II and III to Regulation (EC) No  1223/2009 of the European 
Parliament and of the Council on cosmetic products 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes II and III to Regulati on (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) Tagetes extracts and oils are widely used  fragrance ingredients of many fragrance 
compounds used in perfumery. The Scientific Committee on Consumer Products (SCCP), subsequently replaced by the Scientific Committee on Consumer Safety 
(SCCS), concluded in its opinion of 21 June 2005
2 that Tagetes erecta, Tagetes minuta 
and Tagetes patula extracts and oils should not  be used in cosmetic products as no safe 
limits had been demonstrated.  
(2) Following the submission in August 2013 of an update dossier on the safety 
assessment of Tagetes minuta and patula extr acts and oils, the SCCS concluded in its 
revised opinion of 25 March 20153 that for Tagetes minuta and Tagetes patula extracts 
and essential oils leave-on products (except sunscreen products), a maximum 
concentration in ready to use preparation of  0,01 % is safe, provided that the alpha 
terthienyl (terthiophene) content of those extracts and oils does not exceed 0,35 %. 
The SCCS further concluded that the Tagete s minuta and Tagetes patula extracts and 
oils should not be used in sunscreen products.   
(3) In a comment of 6 October 20164  to its opinion of 25 March 2015, the SCCS 
indicated that for Tagetes minuta and Tagete s patula extracts and essential oils in 
rinse-off products, a maximum concentratio n in ready to use preparation of 0,1 % 
should be set.   
(4) In light of the opinion of the SCCP of 21 J une 2005 there is a potential risk to human 
health arising from the use of Tagetes erec ta flower extract and Tagetes erecta flower 
oil in cosmetic products. Those substances should therefore be prohibited in cosmetic 
products and added in the list of prohibited substances in Annex II to Regulation (EC) 
No 1223/2009.  
                                                 
1 OJ L 342, 22.12.2009, p. 59. 
2 SCCP/0869/05; https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_025d.pdf ;  
3 SCCS/1551/15;  
https://ec.europa.eu/health/scientific_commi ttees/consumer_safety/docs/sccs_o_172.pdf   
4 Minutes of the SCCS Plenary of 6 October 2016; 
https://ec.europa.eu/health/sites/health/files/scie ntific_committees/consumer_safety/docs/sccs2016_mi_
plenary_02_en.pdf   EN 3   EN (5) In light of the opinion of the SCCP of 21 June 2005 as well as the opinion of the 
SCCS of 25 March 2015 and the comment to  that opinion of 6 October 2016,  there is 
a potential risk to human health arising from the use of Tagetes minuta and Tagetes 
patula flower extracts and flower oils in cosmetic products in a concentration 
exceeding 0,01 % in leave-on products and 0,1  % in rinse-off pr oducts and from the 
use of those extracts and oils in a leave-on  or rinse-off product where the content of 
alpha terthienyl (terthiophene) in the extr acts or oils exceeds 0,35 %. There is also a 
potential risk to human health arising from the use of Tagetes minuta and Tagetes patula flower extracts and flower oils  in any concentration in sunscreen. 
(6) It is appropriate to provide for reasonable periods of time in orde r for the industry to 
adapt to the new prohibitions and restrict ions. The complex and lengthy procedure for 
fragrance reformulation should be reflected in a longer than usua l duration of the time 
periods given to the industry for adjustments of products.  
(7) Annexes II and III to Regulation (EC) No  1223/2009 should therefore be amended 
accordingly.  
(8) The measure provided for in this Regulati on are in accordance w ith the opinion of the 
Standing Committee on Cosmetic Products,    
HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the 
Annex to this Regulation.  
Article 2 
From [date = 9 months after the date of entry into force] cosmetic products containing one or 
more of the substances prohibited by this Regul ation and cosmetic products containing one or 
more of the substances restricted by this Re gulation and not complying with the restrictions 
laid down in this Regulation shall not be placed on the Union market. 
 
From [date = 12 months after the date of entry in to force] cosmetic products containing one or 
more of the substances prohibited by this Regul ation and cosmetic products containing one or 
more of the substances restricted by this Re gulation and not complying with the restrictions 
laid down in this Regulation shall not 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. 
 EN 4   EN Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER