EN    EN EN EN 1   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Council Directive 76/768/EEC, concern ing cosmetic products, for the purpose 
of adapting Annexes II and III thereto to technical progress 
(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 Products, Whereas: (1) Directive 76/768/EEC prohibits the use in cosm etic products of substances classified 
as carcinogenic, mutagenic or toxic for repr oduction (hereinafter, CMR substances), of 
category 1, 2 and 3, under Annex I to Counc il Directive 67/548/EEC of 27 June 1967 
on the approximation of laws, regulations a nd administrative provisi ons relating to the 
classification, packaging and labe lling of dangerous substances
2. However, the use of 
substances classified in category 3 pursuan t to Directive 67/548/EEC may be allowed 
subject to evaluation and approval by the Scientific Committee on Consumer Products 
(SCCP).  
(2) Following restrictive measures taken by one Member State on the basis of Article 12 
of Directive 76/768/EEC regarding the use of phytonadione in co smetic products, the 
SCCP was consulted. The scientific comm ittee is of the opinion that use of 
phytonadione in cosmetic products is not sa fe, since it may cause cutaneous allergy 
and individuals so affected may be denied an important therapeutic agent. Therefore 
the substance should be banned. 
(3) Following restrictive measures taken by one Member State on the basis of Article 12 
of Directive 76/768/EEC regarding the use of  diethylene glycol (DEG) in cosmetic 
products, the SCCP was consulted. Considering that this scientific committee is of the 
opinion that DEG should not be used as an i ngredient in cosmetic products, but that a 
maximum concentration of up to 0.1% of  DEG from impurities in the finished 
                                                 
1 OJ L 262, 27.9.1976, p. 169.  
2 OJ L 196, 16.8.1967, p.1. EN 2   EN cosmetic products can be considered to be  safe, this substanc e should be banned for 
use in cosmetic products and its traces limit should be fixed at 0.1%.  
(4) The SCCP considers that toluene, a subs tance classified as a CMR substance of 
category 3 under Annex I to Directive 67/548/EEC, is safe from the general 
toxicological point of view when presen t up to 25% in nail products; however its 
inhalation by children should be avoided.  
(5) Following restrictive measures decided by one  Member State on th e basis of Article 
12 of Directive 76/768/EEC regarding the us e of diethylene glycol monobutyl ether 
(DEGBE) and ethylene glycol monobutyl et her (EGBE) in cosmetic products, the 
SCCP was consulted. This scientific comm ittee is of the opini on that the use of 
DEGBE as a solvent in hair dye formulati ons at a concentration up to 9.0% does not 
pose a risk to the health of consumer. Mo reover, the committee considers that the use 
EGBE as a solvent at a concentration up to  4.0% in oxidative hair dye formulations 
and up to 2.0% in non-oxidative hair dye formulations does not pose a risk to the 
health of the consumer. However, the SCCP did not consider the use of these substances safe when the product is presen ted in aerosol/spray; this potential use 
should therefore be banned. .  
(6) Directive 76/768/EEC should therefore be amended accordingly. 
(7) 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 
 
1. Member States shall adopt and publish, by [Day, Month, Year = 6 months after the 
publication of the Directive3] at the latest, the laws, re gulations and administrative 
provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table 
between those provisions and this Directive. 
They shall apply those provisions from [Day, Month, Year = 9 months after the 
publication of the Directive4]. 
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. 
                                                
 
3 Date to be included. 
4 Date to be included. EN 3   EN 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 3 
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 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 Member of the Commission EN 4   EN ANNEX  
Directive 76/768/EEC is amended as follows: 
(1) In Annex II, the following reference numbers are added: 
Ref. No Chemical name CAS No  
EC No 
[…5] Diethylene glycol (DEG), for 
traces level see Annex III CAS No 111-46-6 
[…6] Phytonadione [INCI], 
phytomenadione [INN] CAS No 84-80-0; EINECS 
No 201-564-2 
 
(2) In Part 1 of Annex III, the following reference numbers […7] to […8] are added: 
Reference 
number Substance Restrictions Conditions 
of use and 
warnings 
which must 
be printed 
on the label 
  Field of 
application 
and/or use Maximum 
authorised 
concentration 
in the 
finished 
cosmetic 
product Other 
limitations 
and 
requirements  
a b c d e f 
[…] Toluene 
CAS No108-
88-3 
EU No303-
625-9 Nail cosmetic 
products 25%  Keep out of 
reach of children 
[…] Diethylene Traces in 0.1%   
                                                 
5 Relevant reference number to be included at the time of the publication 
6 Relevant reference number to be included at the time of the publication 
7 Relevant reference number to be included at the time of the publication 
8 Relevant reference number to be included at the time of the publication EN 5   EN glycol (DEG) 
CAS No 111-
46-6 ingredients  
[…] Butoxydiglycol 
CAS No 112-
34-5 
diethylene 
glycol monobutyl ether
 (DEGBE)  Solvent in hair 
dyes, 
 9% Not to be 
used in sprays  
[…] Butoxyethanol 
CAS No 111-
76-2 
ethylene glycol 
monobutyl ether (EGBE
)  Solvent in 
oxidative hair dyes 
 Solvent in non-
oxidative hair dyes 
 4.0% 
  2.0% Not to be 
used in sprays 
 Not to be 
used in sprays