No C 52/6 Official Journal of the European Communities 28.2. 91 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive amending for the sixth time Directive 76/768/EEC on the 
approximation of the laws of the Member States relating to cosmetic products 
COM(90) 488 final — SYN 307 
(Submitted by the Commission on 12 February 1991) 
(91/C 52/06) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100a 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas legal ambiguities in Council Directive 
76/768/EEC ('), as last amended by Directive 
89/679/EEC (2), particularly in Articles 1 and 2, should 
be removed; 
Whereas it has become apparent that it is desirable that 
data on the ingredients employed in cosmetic products 
be gathered with a view to the assessment of all issues 
relating to their use and of the resulting action at 
Community level with a view particularly to the estab­
lishment of a common nomenclature of ingredients used 
in cosmetic products; whereas the gathering of this data 
can be facilitated if the Commission compiles an 
inventory of the ingredients concerned; whereas this 
inventory is indicative and is not intended to constitute a 
definitive list of substances used in cosmetic products; 
(') OJ No L 262, 27. 9. 1976, p. 169. 
(2) OJ No L 398, 30. 12. 1989, p. 25. Whereas greater transparency is needed regarding the 
ingredients employed in cosmetics if the latter are to be 
placed on the market without any prior procedure and in 
order to obtain the necessary information on the finished 
product solely at the place of manufacture or of initial 
importation into the Community and provide better 
information to the consumer; whereas such transparency 
should be attained by indicating the product's function 
and by indicating the ingredients used in a cosmetic 
product on its packaging; whereas where for practical 
reasons it is impossible to indicate the ingredients and 
any warnings regarding use on the container or the 
packaging, such indications should be given on an 
enclosed leaflet with a suitable symbol; 
Whereas, with regard to the finished cosmetic product, it 
should be made clear which information is to be made 
available to the monitoring authorities of the place of 
manufacture or of initial importation into the 
Community market; whereas this information should 
include all the necessary elements relating to identity, 
quality, safety for human health and the claimed effects 
of the cosmetic product; 
Whereas the competent authority should be apprised of 
the place of manufacture, for reasons of monitoring, and 
of the information needed for rapid and appropriate 
medical treatment in case of difficulties; 
Whereas the Commission should be authorized to amend 
Annexes I and VIII to Directive 76/768/EEC, in view of 
their illustrative and technical natures; 
28. 2.91 Official Journal of the European Communities No C 52/7 
Whereas assessment of the safety of use of the ingre­
dients employed in cosmetics and of the final product 
must take account of the requirements of Council 
Directive 86/609/EEC (*) regarding the protection of 
animals used for experimental and other scientific 
purposes, and in particular Article 7 (2) thereof, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 76/768/EEC is hereby amended as follows: 
1. Article 1 (1) is replaced by the following: 
'1. A "cosmetic product" means any substance or 
preparation intended for placing in contact with the 
various external parts of the human body (epidermis, 
hair system, nails, lips and external genital organs) 
or with the teeth and the mucous membranes of the 
oral cavity with a view to cleaning them, perfuming 
them, protecting them, keeping them in good 
condition, changing their appearance and/or 
correcting body odours.' 
2. Article 2 is replaced by the following: 
'Article 2 
Cosmetic products put on the market within the 
Community must not cause damage to human health 
when they are applied under normal or reasonably 
foreseeable conditions of use, taking account, in 
particular, of every communication made in this 
regard by the manufacturer or his authorized agent 
or by all others responsible for placing these 
products on the Community market.' 
3. The following Article is inserted: 
'Article 5a 
1. Not later than 31 December 1993, the 
Commission shall, on the basis in particular of infor­
mation supplied by the Member States, compile an 
inventory of ingredients employed in cosmetic 
products. 
For the purposes of this Article "cosmetic 
ingredient" means any chemical substance or prep­
aration of synthetic or natural origin, except for 
perfume and aromatic compositions, used in the 
composition of cosmetic products. 
(') OJ No L 358, 18. 12. 1986, p. 1. 2. The inventory shall contain information on: 
— the identity of the ingredient, in particular its 
chemical name and, where appropriate, the 
Einecs, CAS and Colour Index numbers, 
— the function(s) of the ingredient in the final 
product, 
— where appropriate, restrictions and conditions of 
use and warnings which must be printed on the 
label. 
3. The Commission shall publish the inventory 
and shall update it periodically. The inventory is 
indicative and does not constitute a list of the 
substances authorized for use in cosmetic products 
or an exhaustive list of substances used in these 
products.' 
4. In Article 6 (1), the introductory phrase is replaced 
by the following: 
'Member States shall take all measures necessary to 
ensure that cosmetic products may be marketed only 
if the container and packaging bear the following 
information in indelible, easily legible and visible 
lettering, except for the information mentioned in 
(g) hereafter which may be indicated on the 
packaging alone:'. 
5. Article 6 (d) is replaced by the following: 
'(d) particular precautions to be observed in use, 
and especially those listed in the column 
"Conditions of use and warnings which must be 
printed on the label" in Annexes III, IV, VI and 
VII, which must appear on the container and 
packaging as well as any special precautionary 
information on cosmetic products for 
professional use, in particular in hairdressing. 
Where this is impossible for practical reasons, 
this information must appear on an enclosed 
leaflet, with either abbreviated information on 
the container and the packaging or the symbol 
given in Annex VIII referring the consumer to 
the information specified.'. 
6. The following points (f) and (g) are added to Article 
6(1): 
'(f) the function of the product, unless it is clear 
from the description of the product; 
(g) A list of ingredients in descending order of 
weight at the time they are added. This list shall 
be preceded by an appropriate indication 
including the word "ingredients". Where this is 
No C 52/8 Official Journal of the European Communities 28.2.91 
impossible for practical reasons, the ingredients 
must appear on an enclosed leaflet, with either 
abbreviated information on the container and 
the packaging or the symbol given in Annex 
VIII referring the consumer to the ingredients 
specified. Perfume and aromatic compositions 
and their raw materials shall be referred to by 
the word "perfume". Ingredients of a concen­
tration of less than 1 % may be listed in any 
order after those of a concentration of more 
than 1 %. Colouring agents may be listed in 
any order after the other ingredients. 
In accordance with the Article 10 procedure, 
the Commission shall, no later than 31 
December 1993, adopt the criteria and 
conditions under which a manufacturer may, 
for reasons of trade secrecy, apply not to 
include one or more ingredients on the 
abovementioned list.'. 
7. Article 7 (2) is replaced by the following: 
'2. They may, however, require that the 
particulars provided for in Article 6 (1) (b), (c) and 
(d) be expressed at least in their own national or 
official language or languages; they may also require 
that the particulars provided for in Article 6 (1) (f) 
and (g) be expressed in a language easily understood 
by the consumer. To this end, the Commission shall 
adopt a common ingredients nomenclature in 
accordance with the Article 10 procedure.'. 
8. Article 7 (3) is replaced by the following: 
'3. Furthermore, a Member State may require, for 
purposes of prompt and appropriate medical 
treatment in the event of difficulties, that the quali­
tative and quantitative formula of the product be 
made available to the competent authority, which 
shall ensure that this formula is used only for the 
purposes of such treatment. 
Member States shall designate that competent 
authority and send details thereof to the 
Commission, which shall publish this information in 
the Official Journal of the European Communities.' 
9. The following Article is inserted: 
'Article 7a 
1. The manufacturer or his agent, provided he is 
established in the Community, or the person 
responsible for placing imported cosmetic products 
on the Community market, shall, for control purposes, keep the following information readily 
available to the competent authorities of the Member 
State concerned at the place of manufacture or, in 
the case of importation from a non-member country, 
at the place of initial importation into Community 
territory: 
(a) the qualitative and quantitative formula of the 
product; 
(b) the physico-chemical and microbiological specifi­
cations of the raw materials and the finished 
product and the purety and microbiological 
control criteria of the cosmetic product; 
(c) the method of manufacture complying with the 
good manufacturing practice laid down by 
Community law or, failing that, laid down by 
the law of the Member State concerned; 
(d) assessment of the safety for human health of the 
finished product. To this end, the manufacturer 
shall take into consideration the general toxico-
logical profile of the ingredient, its chemical 
structure and its level of exposure. Should the 
same product be manufactured at several places 
on Community territory, the manufacturer may 
choose a single place of manufacture where this 
information will be kept available. With regard 
to this, and when so requested for monitoring 
purposes, he shall be obliged to indicate the 
place so chosen to the monitoring authority/ 
authorities concerned; 
(e) the name and address of the qualified person or 
persons responsible for the assessment referred 
to at (d). This person must have received 
university training in the field of natural 
sciences; 
(f) existing data on undesirable effects on human 
health resulting from use of the cosmetic 
product; 
(g) proof of the effect claimed for the cosmetic 
product, where this is justified by the nature of 
the product. 
2. The assessment of the safety for human health 
referred to in paragraph 1 (d) of this Article shall be 
carried out in accordance with the principles of good 
laboratory practice laid down in Council Directive 
87/18/EEC of 18 December 1986 on the harmon­
ization of laws, regulations and administrative 
provisions relating to the application of the principles 
of good laboratory practice and the verification of 
their application for tests on chemical substances ('). 
28. 2. 91 Official Journal of the European Communities No C 52/9 
3. The information referred to in paragraph 1 
must be available in the national language or 
languages of the Member State concerned, or in a 
language readily understood by the competent auth­
orities. 
4. The manufacturer or his agent, provided he is 
established in the Community, or the person 
responsible for placing imported cosmetic products 
on the Community market, shall notify the 
competent national authority of the place of manu­
facture or of the initial importation of the address of 
the place of manufacture or of initial importation 
into the Community of the cosmetic products before 
the latter are placed on the Community-market. 
5. Member States shall designate the competent 
authorities referred to in paragraphs 1 and 4 and 
shall send details thereof to the Commission, which 
shall publish this information in the Official Journal 
of the European Communities. 
(*) OJNoL 15, 17. 1. 1987, p. 29.' 
10. Article 8 (2) is replaced by the following: 
'2. The amendments necessary for adapting to 
technical progress the Annexes to this Directive and 
the common nomenclature of ingredients used in 
cosmetic products shall be adopted in accordance 
with the same procedure, after consultation of the 
Scientific Committee on Cosmetology.'. 
11. The Annex is added as Annex VIII. Article 2 
1. Member States shall take all necessary measures to 
ensure that from 1 January 1997 neither manufacturers 
nor importers established within the Community place 
on the market products which fail to comply with the 
provisions of this Directive. 
2. Member States shall take all necessary measures to 
ensure that the products referred to in paragraph 1 
cannot be sold or disposed of to the ultimate consumer 
after 31 December 1997. 
Article 3 
1. Member States shall bring into force the laws, 
regulations and administrative provisions necessary to 
comply with this Directive not later than 31 December 
1993 and shall inform the Commission thereof forthwith. 
When Member States adopt these provisions, these shall 
contain a reference to this Directive or shall be accom­
panied by such reference at the time of their official 
publication. The procedure for such reference shall be 
adopted by Member States. 
2. Member States shall communicate to the 
Commission the texts of the provisions of national law 
which they adopt in the field governed by this Directive. 
Article 4 
This Directive is addressed to the Member States. 
ANNEX 
Annex VIII