EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C (2009) XXX 
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending, for the purpose of adaptation to  technical progress, Annexes II and III to 
Council Directive 76/768/EEC concerning cosmetic products  
(Text with EEA relevance) 
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending, for the purpose of adaptation to  technical progress, Annexes II and III to 
Council Directive 76/768/EEC concerning cosmetic products 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the 
laws of the Member States relating to cosmetic products1, and in particular Article 8(2) 
thereof, 
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) The substance Verbena oil ( Lippia citriodora  Kunth.) is currently banned for use in 
cosmetic products, being listed in Annex II to Directive 76/7 68/EEC, under reference 
number 450. The ban of this substance was introduced on the basis of an opinion of 
May 2000 of the Scientific Committee on Co smetic Products and Non-Food Products 
intended for Consumers (SCCNFP), subseq uently replaced by the "Scientific 
Committee on Consumer Products (SCCP )" by Commission Decision 2004/210/EC
2, 
and later by the "Scientific Committee on C onsumer Safety (SCCS )" by Commission 
Decision 2008/721/EC3. The SCCNFP recommended the prohibition of Verbena 
(Lippia citriodora  Kunth.) essential oils and deriva tives, e.g. concrete and absolute, 
when used as a fragrance ingredient , based on the sensitizing potential. 
(2) However, the SCCNFP later concluded in an opinion issued in  2001 that Verbena 
absolute obtained from Lippia citriodora  Kunth. should not be used  such that the level 
in the finished cosmetic products exceeds 0.2% . It is therefore appropriate to include 
Verbena absolute ( Lippia citriodora  Kunth.) together with it s respective restriction in 
Annex III, Part 1 to Directive 76/768/EEC. It  is also appropriate to amend reference 
number 450 of Annex II in order to specify th at the substances Verbena essential oils 
(Lippia citriodora Kunth.) and derivatives other than  absolute are prohibited when 
used as a fragrance ingredient. 
                                                 
1 OJ L 262, 27.9.1976, p. 169. 
2 OJ L 66, 4.3.2004, p. 45. Decision as amended by Commission Decision 2007/263/EC (OJ L 114, 
1.5.2007, p. 14). 
3 OJ L 241, 10.9.2008, p. 21.  
EN 3   EN (3) Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, 
concerning cosmetic products, for the purpose of adapting Annexes II and III thereto 
to technical progress4 included several allyl esters containing allyl alcohol as impurity 
in Annex III, Part 1 to Directive 76/768/EEC . The substance allyl phenethyl ether may 
contain allyl alcohol as impurity as well. Fo r this substance, the SCCNFP issued an 
opinion in 2000 recommending an upper limit of 0.1% of allyl alcohol as impurity. 
(4) In the light of the SCCNFP opinion, as we ll as for consistency reasons, it is 
appropriate to include in Annex III, Part 1 to Directive 76/768/EEC the substance allyl 
phenethyl ether together with  its respective restriction. 
(5) The group of substances Terpene terpenoids  sinpine is curren tly regulated under 
reference number 130 in Annex III, Part 1 to Directive 76/768/EEC. However, the word "sinpine" is a trade name and should th erefore be deleted from the designation of 
that group of substances. 
(6) Directive 76/768/EEC should therefore be amended accordingly. 
(7) In view of a smooth transition from ex isting formulae of cosmetic products to 
formulae which comply with the requirement s laid down in this directive, it is 
necessary to provide for appr opriate transitional periods. 
(8) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annexes II and III to Directive 76/768/EEC are ame nded in accordance with the Annex to this 
Directive. 
Article 2 
 
Member States shall take all necessary measures to ensure that, as from [ Day, Month, Year = 
12 months after the entry into force of this Directive ], no cosmetic products which fail to 
comply with this Directive are placed on th e market by Community manufacturers or by 
importers established within the Community. 
Member States shall take all necessary measures to ensure that, as from [ Day, Month, Year = 
18 months after the entry into force of this Directive ], no cosmetic products which fail to 
comply with this Directive are sold or dispos ed of to the final consumer in the Community. 
                                                
 
4 OJ L 93, 4.4.2008, p. 13.  
EN 4   EN Article 3 
1. Member States shall adopt and publish, by [ insert concrete date = 6 months after 
the entry into force of this Directive ] at the latest, the laws, regulations and 
administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commissi on the text of those provisions. 
They shall apply those provisions from [ insert concrete date = 12 months after the 
entry into force of this Directive ]. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 4 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 5 
This Directive is addressed to the Member States. Done at Brussels, […].  
 For the Commission 
 […] 
 Member of the Commission  
EN 5   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
(1) In Annex II, referen ce number 450, 'Verbena oil ( Lippia citriodora  Kunth.) (CAS No 
8024-12-2), when used as a fragrance ingredient ' is replaced by 'Verbena essential oils ( Lippia 
citriodora  Kunth.) and derivatives other than abso lute (CAS No 8024-12-2), when used as a 
fragrance ingredient'. 
(2) Part 1 of Annex III is amended as follows: (a) the following entry is inserted afte r the entry with reference number 151:  
Restrictions  
Reference 
number  
Substance Field of 
application 
and/or use Maximum 
authorized 
concentration 
in the finished 
cosmetic 
product Other limitations and 
requirements Conditions 
of use and 
warnings 
which must 
be printed 
on the label 
a b c d e f 
"151 bis  Allyl phenethyl ether 
CAS No 14289-65-7 
EC No 238-212-2   Level of free allyl alcohol 
in the ether should be less 
than 0.1 %"  
 
 (b) the following entry is added:  
Restrictions  
Reference 
number  
Substance Field of 
application 
and/or use Maximum 
authorized 
concentration 
in the finished 
cosmetic 
product Other limitations and 
requirements Conditions 
of use and 
warnings 
which must 
be printed 
on the label 
a b c d e f 
"X  
 Verbena absolute 
(Lippia citriodora 
Kunth.) 
CAS No 8024-12-2  0.2%"    
 
 (c) in column "b" of the entry relating to reference number 130, the words 'Terpene 
terpenoids sinpine' are replaced by 'Terpenes and terpenoids'.