76/768/EEC - - - I
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
COUNCIL DIRECTIVE
of 27 July 1976
on the approximation of the laws of the Member States relating to cosmetic products
(76/768/EEC)
(OJ No L 262, 27. 9. 1976, p. 169)
Amended by:
Official Journal
No page date
Council Directive of 24 July 1979 (79/661/EEC) L 192 35 31. 7. 1979
Commission Directive of 11 February 1982 (82/147/EEC) L 63 26 6. 3. 1982Council Directive of 17 May 1982 (82/368/EEC) L 167 1 15. 6. 1982Second Commission Directive of 30 March 1983 (83/191/EEC) L 109 25 26. 4. 1983Third Commission Directive of 29 June 1983 (83/341/EEC) L 188 15 13. 7. 1983Fourth Commission Directive of 22 September 1983 (83/496/EEC) L 275 20 8. 10. 1983Council Directive of 26 October 1983 (83/574/EEC) L 332 38 28. 11. 1983Fifth Commission Directive of 18 July 1984 (84/415/EEC) L 228 31 25. 8. 1984Sixth Commission Directive of 16 July 1985 (85/391/EEC) L 224 40 22. 8. 1985Seventh Commission Directive of 28 February 1986 (86/179/EEC) L 138 40 24. 5. 1986Eighth Commission Directive of 26 March 1986 (86/199/EEC) L 149 38 3. 6. 1986Ninth Commission Directive of 2 February 1987 (87/137/EEC) L 56 20 26. 2. 1987T enth Commission Directive of 2 March 1988 (88/233/EEC) L 105 11 26. 4. 1988Council Directive of 21 December 1988 (88/667/EEC) L 382 46 31. 12. 1988Eleventh Commission Directive of 21 February 1989 (89/174/EEC) L 64 10 8. 3. 1989Council Directive of 21 December 1989 (89/679/EEC) L 398 25 30. 12. 1989T welfth Commission Directive of 20 February 1990 (90/121/EEC) L 71 40 17. 3. 1990Thirteenth Commission Directive of 12 March 1991 (91/184/EEC) L 91 59 12. 4. 1991Fourteenth Commission Directive of 18 February 1992 (92/8/EEC) L 70 23 17. 3. 1992Fifteenth Commission Directive of 21 October 1992 (92/86/EEC) L 325 18 11. 11. 1992Council Directive of 14 June 1993 (93/35/EEC) L 151 32 23. 6. 1993Sixteenth Commission Directive of 22 June 1993 (93/47/EEC) L 203 24 13. 8. 1993Seventeenth Commission Directive of 29 June 1994 (94/32/EC) L 181 31 15. 7. 199418th Commission Directive of 10 July 1995 (95/34/EC) L 167 19 18. 7. 1995Nineteenth Commission Directive of 25 June 1996 (96/41/EC) L 198 36 8. 8. 1996
76/768/EEC - - - I
20th Commission Directive of 10 January 1997 (97/1/EC) L 16 85 18. 1. 1997
Commission Directive of 17 April l997 (97/18/EC) L 114 43 1. 5. 199721st Commission Directive of 14 July 1997 (97/45/EC) L 196 77 24. 7. 1997
76/768/EEC - - - I
T wenty-second Commission Directive of 5 March 1998 (98/16/EC) L 77 44 14. 3. 1998
23rd Commission Directive of 3 September 1998 (98/62/EC) L 253 20 15. 9. 1998
Amended by:
A1 Act of Accession of Greece L 291 108 19. 11. 1979
A2 Act of Accession of Spain and Portugal L 302 218 15. 11. 1985
Corrected by:
C1 Corrigendum, OJ No L 255, 25. 9. 1984, p. 28 (84/4l5/EEC)
C2 Corrigendum, OJ No L 157, 24. 6. 1988, p. 38 (88/233/EEC)
C3 Corrigendum, OJ No L 199, 13. 7. 1989, p. 23 (89/174/EEC)
C4 Corrigendum, OJ No L 273, 25. 10. 1994, p. 38 (94/32/EC)
76/768/EEC - - - I
ICOUNCIL DIRECTIVE
of 27 July 1976
on the approximation of the laws of the Member States relating to cosmetic products
(76/768/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the T reaty establishing the European
Economic Community, and in particular Article 100
thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parlia-
ment (1),
Having regard to the opinion of the Economic and Social
Committee (2),
Whereas the provisions laid down by law, regulation or ad-
ministrative action in force in the Member States definethe composition characteristics to which cosmetic products
must conform and prescribe rules for their labelling and
for their packaging; whereas these provisions differ from
one Member State to another;
Whereas the differences between these laws oblige Com-
munity cosmetic producers to vary their production accord-
ing to the Member State for which the products are in-
tended; whereas, consequently, they hinder trade in these
products and, as a result, have a direct effect on the estab-
lishment and functioning of the common market;
Whereas the main objective of these laws is the safeguard-
ing of public health and whereas, as a result, the pursuit of
the same objective must inspire Community legislation in
this sector; whereas, however, this objective must be at-
tained by means which also take account of economic and
technological requirements;
Whereas it is necessary to determine at Community level
the regulations which must be observed as regards the
composition, labelling and packaging of cosmetic products;
(1) OJ No C 40, 8. 4. 1974, p. 71.
(2) OJ No C 60, 26. 7. 1973, p. 16.
76/768/EEC - - - I
IIWhereas this Directive relates only to cosmetic products
and not to pharmaceutical specialities and medicinal prod-
ucts; whereas for this purpose it is necessary to define the
scope of the Directive by delimiting the field of cosmetics
from that of pharmaceuticals; whereas this delimitation fol-
lows in particular from the detailed definition of cosmetic
products, which refers both to their areas of application
and to the purposes of their use; whereas this Directive is
not applicable to the products that fall under the definition
of cosmetic product but are exclusively intended to protect
from disease; whereas, moreover, it is advisable to specify
that certain products come under this definition, whilst
products containing substances or preparations intended to
be ingested, inhaled, injected or implanted in the human
body do not come under the field of cosmetics;
Whereas in the present state of research, it is advisable to
exclude cosmetic products containing one of the substanceslisted in Annex V from the scope of this Directive;
Whereas cosmetic products must not be harmful under
normal or foreseeable conditions of use; whereas in par-
ticular it is necessary to take into account the possibility of
danger to zones of the body that are contiguous to the
area of application;
Whereas, in particular, the determination of the methods
of analysis together with possible modifications or addi-
tions which may have to be made to them on the basis of
the results of scientific and technical research, are imple-
menting measures of a technical nature; whereas it is ad-
visable to entrust their adoption to the Commission, sub-
ject to certain conditions specified in this Directive, for the
purpose of simplifying and accelerating the procedure;
Whereas technical progress necessitates rapid adaptation of
the technical provisions defined in this Directive and in
subsequent Directives in this field; whereas it is advisable,
in order to facilitate implementation of the measures
necessary for this purpose, to provide for a procedure es-
tablishing close cooperation between the Member States
and the Commission within the Committee for adaptation
to technical progress of Directives aimed at the removal of
technical obstacles to trade in the cosmetic products sec-
tor;
Whereas it is necessary, on the basis of scientific and
technical research, to draw up proposals for lists of author-
ized substances which could include antioxidants, hair dyes,
preservatives and ultraviolet filters, taking into account in
particular the problem of sensitization;
Whereas it could happen that although conforming to the
provisions of this Directive and its Annexes, cosmetic prod-
ucts placed on the market might endanger public health;
whereas it is therefore advisable to provide for a pro-
cedure intended to remove this danger,
HAS ADOPTED THIS DIRECTIVE:
76/768/EEC - - - I
1Article 1
1. A “cosmetic product” shall mean any substance or
preparation intended to be placed in contact with the vari-
ous external parts of the human body (epidermis, hair sys-
tem, nails, lips and external genital organs) or with the
teeth and the mucous membranes of the oral cavity with a
view exclusively or mainly to cleaning them, perfuming
them, changing their appearance and/or correcting body
odours and/or protecting them or keeping them in good
condition.
2. The products to be considered as cosmetic productswithin the meaning of this definition are listed in Annex I.
3. Cosmetic products containing one of the substanceslisted in Annex V shall be excluded from the scope of this
Directive. Member States may take such measures as they
deem necessary with regard to those products.
Article 2
A cosmetic product put on the market within the Com-
munity must not cause damage to human health when ap-
plied under normal or reasonably foreseeable conditions of
use, taking account, in particular, of the product’s pres-
entation, its labelling, any instructions for its use and dis-
posal as well as any other indication or information pro-
vided by the manufacturer or his authorized agent or by
any other person responsible for placing the product on
the Community market.
The provision of such warnings shall not, in any event,
exempt any person from compliance with the other re-
quirements laid down in this Directive.
Article 3
Member States shall take all necessary measures to ensure
that only cosmetic products which conform to the provi-
sions of this Directive and its Annexes may be put on the
market.
Article 4
1. Without prejudice to their general obligations deriving
from Article 2, Member States shall prohibit the market-
ing of cosmetic products containing:
(a) substances listed in Annex II;
(b) substances listed in the first part of Annex III, beyond
the limits and outside the conditions laid down;76/768/EEC
93/35/EEC
76/768/EEC
88/667/EEC
93/35/EEC
76/768/EEC
82/368/EEC
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2(c) colouring agents other than those listed in Annex IV ,
Part 1, with the exception of cosmetic products con-
taining colouring agents intended solely to colour hair;
(d) colouring agents listed in Annex IV , Part 1, used out-
side the conditions laid down, with the exception of
cosmetic products containing colouring agents intended
solely to colour hair;
(e) preservatives other than those listed in Annex VI,
Part 1;
(f) preservatives listed in Annex VI, Part 1, beyond the
limits and outside the conditions laid down, unless
other concentrations are used for specific purposes ap-
parent from the presentation of the product;
(g) UV filters other than those listed in Part 1 of Annex
VII;
(h) UV filters listed in Part 1 of Annex VII, beyond the
limits and outside the conditions laid down therein;
/
(i) ingredients or combinations of ingredients tested on
animals after 30 June 2000 in order to meet the re-
quirements of this Directive.
If there has been insufficient progress in developing
satisfactory methods to replace animal testing, and in
particular in those cases where alternative methods of
testing, despite all reasonable endeavours, have not
been scientifically validated as offering an equivalent
level of protection for the consumer, taking into ac-
count OECD toxicity test guidelines, the Commission
shall, by 1 January 1997, submit draft measures to
postpone the date of implementation of this provision,
for a sufficient period, and in any case for no less than
two years, in accordance with the procedure laid down
in Article 10. Before submitting such measures, the
Commission will consult the Scientific Committee on
Cosmetology.88/667/EEC
82/368/EEC
83/574/EEC
93/35/EEC
97/18/EC
76/768/EEC - - - I
3The Commission shall present an annual report to the
European Parliament and the Council on progress in
the development, validation and legal acceptance of al-
ternative methods to those involving experiments on
animals. That report shall contain precise data on the
number and type of experiments relating to cosmetic
products carried out on animals. The Member States
shall be obliged to collect that information in addition
to collecting statistics as laid down by Directive
86/609/EEC on the protection of animals used for ex-
perimental and other scientific purposes. The Commis-
sion shall in particular ensure the development, valida-
tion and legal acceptance of experimental methods
which do not use live animals.
2. The presence of traces of the substances listed inAnnex II shall be allowed provided that such presence is
technically unavoidable in good manufacturing practiceand that it conforms with Article 2.
Article 5
Member States shall allow the marketing of cosmetic prod-
ucts containing:
(a) the substances listed in Annex III, Part 2, within the
limits and under the conditions laid down, up to the
d a t e si nc o l u m n( g )o ft h a tA n n e x ;
(b) the colouring agents listed in Annex IV , Part 2, within
the limits and under the conditions laid down, until the
admission dates given in that Annex;
(c) the preservatives listed in Annex VI, Part 2, within the
limits and under the condition laid down, until the
dates given in column (f) of that Annex. However,
some of these substances may be used in other con-
centrations for specific purposes apparent from the
presentation of the product;
(d) the UV filters listed in Part 2 of Annex VII, within the
limits and under the conditions laid down, until the
dates given in column (f) of that Annex.
At these dates, these substances, colouring agents, preserv-
atives and UV filters shall be:
— definitively allowed, or
— definitively prohibited (Annex II), or
— maintained for a given period specified in Part 2 of
Annexes III, IV , VI and VII, or93/35/EEC
82/368/EEC
88/667/EEC
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4— deleted from all the Annexes, on the basis of available
scientific information or because they are no longer
used.
Article 5a
1. No later than 14 December 1994 the Commission
shall, under the procedure laid down in Article 10, compile
an inventory of ingredients employed in cosmetic products,
on the basis in particular of information supplied by the
industry concerned.
For the purposes of this Article, “cosmetic ingredient”
shall mean any chemical substance or preparation of syn-
thetic or natural origin, except for perfume and aromatic
compositions, used in the composition of cosmetic prod-
ucts.
The inventory shall be divided into two sections: one con-
cerning perfume and aromatic raw materials and the sec-
ond concerning other substances.
2. The inventory shall contain informtion on:
— the identity of each ingredient, in particular its chemi-
cal name, the CTFA name, the European Pharmaco-
poeia name, the international non-proprietary names
recommended by the World Health Organization, the
Einecs, Iupac, CAS and colour index numbers, and the
common name referred to in Article 7 (2),
— the usual 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 by
reference to the Annexes.
3. The Commission shall publish the inventory and shall
update it periodically under the procedure provided for in
Article 10. The inventory shall be indicative and shall not
constitute a list of the substances authorized for use in cos-metic products.
Article 6
1. 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; the informa-
tion mentioned in point (g) may, however, be indicated on
the packaging alone:
(a) the name or style and the address or registered office
of the manufacturer or the person responsible for
marketing the cosmetic product who is established
within the Community. Such information may be ab-
breviated in so far as the abbreviation makes it gen-
erally possible to identify the undertaking. MemberStates may require that the country of origin be speci-
fied for goods manufactured outside the Community;88/667/EEC
93/35/EEC
88/667/EEC
93/35/EEC
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5b) the nominal content at the time of packaging, given by
weight or by volume, except in the case of packaging
containing less than five grams or five millilitres, free
samples and single-application packs; for pre-packages
normally sold as a number of items, for which details
of weight or volume are not significant, the content
need not be given provided the number of items ap-
pears on the packaging. This information need not be
given if the number of items is easy to see from the
outside or if the product is normally only sold individ-
ually;
c) the date of minimum durability. The date of minimum
durability of a cosmetic product shall be the date until
which this product, stored under appropriate condi-
tions, continues to fulfil its initial function and, in par-
ticular, remains in conformity with Article 2.
T h ed a t eo fm i n i m u md u r a b i l i t ys h a l lb ei n d i c a t e db y
the words: “Best used before the end of...’’ followed by
either:
—t h e d a t e i t s e l f , o r
— details of where the date appears on the packag-
ing.
If necessary, this information shall be supplemented by
an indication of the conditions which must be satisfied
to guarantee the stated durability.
The date shall be clearly expressed and shall consist of
the month and the year in that order. Indication of the
date of durability shall not be mandatory for cosmetic
products the minimum durability of which exceeds
30 months;
(d) particular precautions to be observed in use, especially
those listed in the column “Conditions of use and
warnings which must be printed on the label” in An-
nexes III, IV , VI and VII, which must appear on the
container and packaging, as well as any special precau-
tionary information on cosmetic products for pro-
fessional use, in particular in hairdressing. Where this
is impossible for practical reasons, an enclosed leaflet,
label, tape or card must contain that information to
which the consumer is referred either by abbreviated
information or the symbol given in Annex VIII, which
must appear on the container and the packaging;88/667/EEC
93/35/EEC
76/768/EEC - - - I
6(e) the batch number of manufacture or the reference for
identifying the goods. Where this is impossible for
practical reasons because the cosmetic products are too
small, such information need appear only on the pack-
aging;
(f) the function of the product, unless it is clear from the
presentation of the product;
(g) a list of ingredients in descending order of weight at
the time they are added. That list shall be preceded by
the word “ingredients”. Where that is impossible for
practical reasons, an enclosed leaflet, label, tape or
card must contain the ingredients to which the con-
sumer is referred either by abbreviated information or
the symbol given in Annex VIII, which must appear on
the container and the packaging.
The following shall not, however, be regarded as ingre-
dients:
— impurities in the raw materials used,
— subsidiary technical materials used in the prepara-
tion but not present in the final product,
— materials used in strictly necessary quantities as
solvents or as carriers for perfume and aromatic
compositions.
Perfume and aromatic compositions and their raw ma-
terials shall be referred to by the word “perfume” or
“flavour”. Ingredients in concentrations of less than
1 % may be listed in any order after those in con-
centrations of more than 1 %. Colouring agents may
be listed in any order after the other ingredients, in
accordance with the colour index number or denomina-
tion adopted in Annex IV .
For decorative cosmetic products marketed in several
colour shades, all colouring agents used in the range
may be listed, provided that the terms “may contain”
are added.
An ingredient must be identified by the common name
referred to in Article 7 (2) or, failing that, by one of
the names referred to in Article 5a (2), first indent.
In accordance with the procedure laid down in Article
10, the Commission shall, no later than 14 December
1994, 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 abo-
vementioned list.88/667/EEC
93/35/EEC
76/768/EEC - - - I
7Where it is impracticable, for reasons of size or shape, for
the particulars referred to in points (d) and (g) to appear
in an enclosed leaflet, those particulars shall appear on a
label, tape or card which is enclosed or attached to the
cosmetic product.
In the case of soap, bath balls and other small products
where it is impraticable, for reasons of size or shape, for
the particulars referred to in point (g) to appear on a
label, tag, tape or card or in an enclosed leaflet, those par-
ticulars shall appear on a notice in immediate proximity to
the container in which the cosmetic product is exposed for
sale.
2. For cosmetic products that are not pre-packaged, arepackaged at the point of sale at the purchaser’s request, or
are pre-packaged for immediate sale, Member States shall
adopt detailed rules for indication of the particulars re-
ferred to in paragraph 1.
3. Member States shall take all measures necessary to
ensure that, in the labelling, putting up for sale and adver-
tising of cosmetic products, text, names, trade marks, pic-
tures and figurative or other signs are not used to imply
that these products have characteristics which they do not
have. Furthermore, any reference to testing on
animals
must state clearly whether the tests carried out involved
the finished product and/or its ingredients.
Article 7
1. Member States may not, for reasons related to the
requirements laid down in this Directive and the Annexes
thereto, refuse, prohibit or restrict the marketing of any
cosmetic products which comply with the requirements of
this Directive and the Annexes thereto.
2. They may, however, require that the particulars pro-vided for in Article 6 (1) (b), (c), (d) and (f) be expressedat least in their own national or official language or lan-
guages; they may also require that the particulars provided
for in Article 6 (1) (g) be expressed in a language easily
understood by the consumer. T o that end, the Commission
shall adopt a common ingredients nomenclature in accord-
ance with the Article 10 procedure.
3. Furthermore, a Member State may, for purposes of
prompt and appropriate medical treatment in the event of
difficulties, require that appropriate and adequate informa-
tion on substances used in cosmetic products be made
available to the competent authority, which shall ensure
that that information is used only for the purposes of such
treatment.93/35/EEC
88/667/EEC
93/35/EEC
76/768/EEC
93/35/EEC
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8Each Member State shall designate a competent authority
and send details thereof to the Commission, which shall
p u b l i s ht h a ti n f o r m a t i o ni nt h e Official Journal of the Euro-
pean Communities .
Article 7a
1. The manufacturer or his agent or the person to whose
order a cosmetic product is manufactured or the person
responsible for placing an imported cosmetic product on
the Community market shall for control purposes keep the
following information readily accessible to the competent
authorities of the Member State concerned at the address
specified on the label in accordance with Article 6 (1) (a):
(a) the qualitative and quantitative composition of the
product; in the case of perfume compositions and per-
f u m e s ,t h en a m ea n dc o d en u m b e ro ft h ec o m p o s i t i o n
and the identity of the supplier;
(b) the physico-chemical and microbiological specifications
of the raw materials and the finished product and the
purity and microbiological control criteria of the cos-
metic product;
(c) the method of manufacture complying with the good
manufacturing practice laid down by Community lawor, failing that, laid down by the law of the Member
State concerned; the person responsible for manufac-
ture or first importation into the Community must pos-
sess an appropriate level of professional qualification
or experience in accordance with the legislation and
practice of the Member State which is the place of
manufacture or first importation;
(d) assessment of the safety for human health of the fin-
ished product. T o that end the manufacturer shall take
into consideration the general toxicological profile of
the ingredient, its chemical structure and its level of
exposure.
Should the same product be manufactured at several
places within Community territory, the manufacturer
may choose a single place of manufacture where that
information will be kept available. In this connection,
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 per-
sons responsible for the assessment referred to in (d).
That person must hold a diploma as defined in Ar-
ticle 1 of Directive 89/48/EEC in the field of phar-
macy, toxicology, dermatology, medicine or a similar
discipline;
(f) existing data on undesirable effects on human health
resulting from use of the cosmetic product;93/35/EEC
76/768/EEC - - - I
9(g) proof of the effect claimed for the cosmetic product,
w h e r ej u s t i f i e db yt h en a t u r eo ft h ee f f e c to rp r o d u c t .
2. The assessment of the safety for human health re-
ferred to in paragraph 1 (d) shall be carried out in accord-
ance with the principle of good laboratory practice laid
down in Council Directive 87/18/EEC of 18 December
1986 on the harmonization of laws, regulations and admin-
istrative provisions relating to the application of the prin-
ciples of good laboratory practice and the verification of
their application for tests on chemical substances (3).
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 under-
stood by the competent authorities.
4. The manufacturer or his agent, or the person to
whose order a cosmetic product is manufactured, or the
person responsible for placing imported cosmetic productson the Community market, shall notify the competent
authority of the Member State of the place of manufacture
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 author-
ities referred to in paragraphs 1 and 4 and shall send de-
tails thereof to the Commission, which shall publish that
information in the Official Journal of the European
Communities .
The Member States shall ensure that the abovementioned
authorities continue to cooperate in areas where such
cooperation is necessary to the smooth application of this
Directive.
Article 8
1. In accordance with the procedure laid down in Ar-
ticle 10 the following shall be determined:
— the methods of analysis necessary for checking the
composition of cosmetic products,
— the criteria of microbiological and chemical purity for
cosmetic products and methods for checking com-
pliance with those criteria.
2. The common nomenclature of ingredients used in cos-metic products and, after consultation of the Scientific
Committee on Cosmetology, the amendments necessary for
the adaptation to technical progress of the Annexes shall
be adopted in accordance with the same procedure, as ap-
propriate.
(3) OJ No L 15, 17. 1. 1987, p. 29.93/35/EEC
82/368/EEC
93/35/EEC
76/768/EEC - - - I
10Article 8a
1. Notwithstanding Article 4 and without prejudice to
Article 8 (2), a Member State may authorize the use with-
in its territory of other substances not contained in the
lists of substances allowed, for certain cosmetic products
specified in its national authorization, subject to the fol-
lowing conditions:
(a) the authorization must be limited to a maximum
period of three years;
(b) the Member State must carry out an official check on
cosmetic products manufactured from the substance or
preparation use of which it has authorized;
(c) cosmetic products thus manufactured must bear a dis-
tinctive indication which will be defined in the author-
ization.
2. The Member Stats shall forward to the Commission
and to the other Member States the next of any authoriza-tion decision taken pursuant to paragraph 1 within two
months of the date on which it came into effect.
3. Before expiry of the three-year period provided for in
paragraph 1, the Member State may submit to the Com-
mission a request for the inclusion in a list of permitted
substances of the substance given national authorization in
accordance with paragraph 1. At the same time, it shall
supply supporting documents setting out the grounds on
which it deems such inclusion justified and shall indicate
the uses for which the substance or preparation is in-
tended. Within 18 months of submission of the request, a
decision shall be taken on the basis of the latest scientific
and technical knowledge, after consultation, at the initiat-
ive of the Commission or of a Member State, of the Scien-
tific Committee for Cosmetology and in accordance with
the procedure laid down in Article 10 as to whether the
substance in question may be included in a list of per-
mitted substances or whether the national authorization
should be revoked. Notwithstanding paragraph 1 (a), the
national authorization shall remain in force until a decision
i st a k e no nt h er e q u e s tf o ri n c l u s i o ni nt h el i s t .
Article 9
1. The Committee on the Adaptation to T echnical Prog-
ress of the Directives on the Removal of T echnical Barriers
to T rade in the Cosmetic Products Sector, hereinafter
called ’the Committee’, is hereby set up. It shall consist of
representatives of the Member States with a representative
of the Commission as chairman.
2. The Committee shall adopt its own rules of pro-
cedure.82/368/EEC
76/768/EEC
76/768/EEC - - - I
11Article 10
1. Where the procedure laid down in this Article is to
be followed, matters shall be referred to the Committee by
the chairman, either on his own initiative or at the request
of the representative of a Member State.
2. The representative of the Commission shall submit to
the Committee a draft of the measures to be adopted. The
Committee shall deliver its opinion on the draft within a
time limit set by the chairman according to the urgency of
the matter. Opinions shall be adopted by a majority of 54
votes, the votes of Member States being weighted as pro-
vided for in Article 148 (2) of the T reaty. The chairman
shall not vote.
3. (a) The Commission shall adopt the proposed mea-
sures when they are in accordance with the opinion
of the Committee.
(b) Where the proposed measures are not in accor-
dance with the opinion of the Committee, or if no
opinion is adopted, the Commission shall without
delay propose to the Council the measures to be
adopted. The Council shall act by a qualified ma-
jority.
(c) If, within three months of the proposal being sub-
mitted to it, the Council has not acted, the pro-
posed measures shall be adopted by the Commis-
sion.
Article 11
Without prejudice to Article 5 and not later than one year
after expiry of the period laid down in Article 14 (1) for
implementation of this Directive by the Member States,
the Commission shall, on the basis of the results of the
latest scientific and technical research, submit to the Coun-
cil appropriate proposals establishing lists of permitted
substances.
Article 12
1. If a Member State notes, on the basis of a substan-
tiated justification, that a cosmetic product, although com-
plying with the requirements of the Directive, represents a
hazard to health, it may provisionally prohibit the market-
ing of that product in its territory or subject it to special
conditions. It shall immediately inform the other Member
States and the Commission thereof, stating the grounds for
its decision.
2. The Commission shall as soon as possible consult theMember States concerned, following which it shall deliver
its opinion without delay and take the appropriate steps.76/768/EEC
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123. If the Commission is of the opinion that technical
adaptations to the Directive are necessary, such adapta-
tions shall be adopted by either the Commission or the
Council in accordance with the procedure laid down in Ar-
ticle 10. In that event, the Member State which has
adopted safeguard measures may maintain them until entry
into force of the adaptations.
Article 13
Precise reasons shall be stated for any individual measures
placing a restriction or ban on the marketing of cosmetic
products taken pursuant to this Directive. It shall be noti-
fied to the party concerned together with particulars of the
remedies available to him under the laws in force in the
Member States and of the time limits allowed for the exer-
cise of such remedies.
Article 14
1. Member States shall bring into force the provisions
needed in order to comply with this Directive within
18 months of its notification and shall forthwith inform the
Commission thereof.
2. Member States may, however, for a period of
36 months from notification of this Directive, authorize the
marketing in their territory of cosmetic products which do
not conform to the requirements of the Directive.
3. Member States shall ensure that the texts of such
provisions of national law as they adopt in the field gov-
erned by this Directive ate communicated to the Commis-
sion.
Article 15
This Directive is addressed to the Member States.76/768/EEC
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13ANNEX I
ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PROD-
UCTS
— Creams, emulsions, lotions, gels and oils for the skin (hands,
f a c e ,f e e t ,e t c . ) .
— Face masks (with the exception of peeling products).
— Tinted bases (liquids, pastes, powders).— Make-up powders, after-bath powders, hygienic powders, etc.
— T oilet soaps, deodorant soaps, etc.
— Perfumes, toilet waters and eau de Cologne.— Bath and shower preparations (salts, foams, oils, gels, etc.).
— Depilatories.
— Deodorants and anti-perspirants.— Hair care products:
— hair tints and bleaches,
— products for waving, straightening and fixing,— setting products,
— cleansing products (lotions, powders, shampoos),
— conditioning products (lotions, creams, oils),— hairdressing products (lotions, lacquers, brilliantines).
— Shaving products (creams, foams, lotions, etc.).
— Products for making up and removing makeup from the face
and the eyes.
— Products intended for application to the lips.— Products for care of the teeth and the mouth.
— Products for nail care and make-up.
— Products for external intimate hygiene.—S u n b a t h i n g p r o d u c t s .
— Products for tanning without sun.
— Skin-whitening products.—A n t i - w r i n k l e p r o d u c t s .76/768/EEC
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14ANNEX II
LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF
THE COMPOSITION OF COSMETIC PRODUCTS
1. N-5-Chlorobenzoxazol-2-ylacetamide
2.2-Acetoxyethyltrimethylammonium hydroxide (acetylcholine)
and its salts
3. Deanol aceglumate* (1)
4. Spironolactone*
5. [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid
and its salts
6. Methotrexate*
7. Aminocaproic acid* and its salts
8. Cinchophen*, its salts, derivatives and salts of these deriva-
tives
9. Thyropropic acid* and its salts
10. Trichloroacetic acid11.Aconitum napellus L. (leaves, roots and galenical prepara-
tions)
12. Aconitine (principal alkaloid of Aconitum napellus L. )a n di t s
salts
13.Adonis vernalis L . and its preparations
14. Epinephrine*
15.Rauwolfia serpentina alkaloids and their salts
16. Alkyne alcohols, their esters, ethers and salts17. Isoprenaline*
18. Allyl isothiocyanate
19. Alloclamide* and its salts20. Nalorphine*, its salts and ethers
21. Sympathicomimetic amines acting on the central nervous sys-
tem: any substance contained in the first list of medicamentswhich are subject to medical prescription and are referred to
i nr e s o l u t i o nA P( 6 9 )2o ft h eC o u n c i lo fE u r o p e
22. Aniline, its salts and its halogenated and sulphonated deriva-
tives
23. Betoxycaine* and its salts
24. Zoxazolamine*25. Procainamide*, its salts and derivatives
26. Benzidine
27. Tuaminoheptane*, its isomers and salts28. Octodrine* and its salts
29. 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its
salts
30. 1,3-dimethylpentylamine and its salts31. 4-Aminosalicylic acid and its salts
(1) In this Directive, names followed by an asterisk are those pub-
lished in ‘Computer print-out 1975, Intemational Non-proprietary
Names (INN) for pharmaceutical products, Lists 1- - -33 of proposed
INN’, WHO, Geneva, August 1975.76/768/EEC
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1532. T oluidines, their isomers, salts and halogenated and sulpho-
nated derivatives
33. Xylidines, their isomers, salts and halogenated and sulpho-
nated derivatives
34. Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chro-
men-7-one)
35.Ammi majus and its galenical preparations
36. 2,3-Dichloro-2-methylbutane
37. Substances with androgenic effect
38. Anthracene oil39. Antibiotics 
40. Antimony and its compounds
41.Apocynum cannabinum L . and its preparations
42. Apomorphine (R 5,6,6a 7-tetrahydro-6-methyl-4
H-dibenzo
[de,g]quinoline-10,11-diol) and its salts
43. Arsenic and its compounds44.Atropa belladonna L . and its preparations
45. Atropine, its salts and derivatives
46. Barium salts, with the exception of barium sulphate, barium
sulphide under the conditions laid down in Annex III, Part 1,
and lakes, salts and pigments prepared from the colouring
agents listed with the reference (5) in Annex III, Part 2 and
Annex IV , Part 2.
47. Benzene
48. Benzimidazol-2(3 H)-one
49. Benzazepines and benzodiazepines
50. 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylo-
caine) and its salts
51. 2,2,6- Trimethyl-4-piperidyl benzoate (benzamine) and its salts
52.Isocarboxazid*
53. Bendroflumethiazide* and its derivatives
54. Beryllium and its compounds
55. Bromine, elemental56. Bretylium tosilate*
57. Carbromal*
58. Bromisoval*59. Brompheniramine* and its salts
60. Benzilonium bromide*
61. T etrylammonium bromide*62. Brucine
63. Tetracaine* and its salts
64. Mofebutazone*65. T olbutamide*
66. Carbutamide*
67. Phenylbutazone*
68. Cadmium and its compounds76/768/EEC
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1669. Cantharides, Cantharis vesicatoria
70. (1R,25)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride
(cantharidin)
71. Phenprobamate*72. Nitroderivatives of
carbazole
73. Carbon disulphide
74. Catalase75. Cephaeline and its salts
76.Chenopodium ambrosioides (essential oil)
77. 2,2,2- Trichloroethane-1,1-diol78. Chlorine
79. Chlorpropamide*
80. Diphenoxylate*
hydrochloride
81. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride
(chrysoidine citrate hydrochloride)
82. Chlorzoxazone*83. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-
ISO)
84. Chlorprothixene* and its salts85. Clofenamide*
86.N,N
-bis(2-chloroethyl)methylamine N-oxide and its salts
87. Chlormethine* and its salts
88. Cyclophosphamide* and its salts
89. Mannomustine* and its salts90. Butanilicaine* and its salts
91.
Chlormezanone*
92. Triparanol*93. 2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlo-
rophacinone-ISO)
94. Chlorphenoxamine*95. 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione
(chloro-
phacinone — ISO)
96. Chloroethane97. Chromium; chromic acid and its salts
98.Claviceps purpurea Tul., its alkaloids and galenical prepara-
tions
99.Conium maculatum L. (fruit, powder, galenical preparations)
100.Glycyclamide*
101.Cobalt benzenesulphonate102.Colchicine, its salts and derivatives
103.Colchicoside and its derivatives
104.Golchicum autumnale L . and its galenical preparations
105.Convallatoxin
106.Anamirta cocculus L .( f r u i t )
107.Croton tiglium (oil)
108.1-Butyl-3-( N-crotonoylsulphanilyl)urea76/768/EEC
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17109.Curare and curarine
110.Synthetic curarizants
111.Hydrogen cyanide and its salts
112.2- α-Cyclohexylbenzyl( N,N,N’,N’, -tetraethyl)trimethylenedia-
mine (phenetamine)
113.Cyclomenol* and its salts
114.Sodium hexacyclonate*115.Hexapropymate*
116.Dextropropoxyphene*
117.O,O’
-Diacetyl- N-allyl- N-normorphine
118.Pipazetate* and its salts
119.5-(αβ-Dibromophenethyl)-5-methylhydantoin
120.N,N’-Pentamethylenebis (trimethylammonium salts), e.g. pen-
tamethonium bromide*
121.N,N’-[(Methylimino)diethylene]bis(ethyldimethylammonium)
salts, e.g. azamethonium bromide*
122.Cyclarbamate*
123.Clofenotane* DDT (ISO)
124.N,N’- Hexamethylenebis(trimethylammonium) salts, e.g.
hexamethonium bromide*
125.Dichloroethanes (ethylene chlorides)
126.Dichloroethylenes (acetylene chlorides)
127.Lysergide* and its salts
128.2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts
129.Cinchocaine* and its salts
130.3-Diethylaminopropyl cinnamate
131.O,O’-Diethyl O-4-nitrophenyl phosphorothioate (parathion—
lSO)
132.[Oxalylbisiminoethylene)]bis[( o-chlorobenzyl)diethylammo-
nium salts], e.g. ambenomium cloride*
133.Methyprylon* and its salts
134.Digitaline and all heterosides of Digitalis purpurea L .
135.7-[2-Hydroxy-3-(2-hydroxyethyl- N-methylamino)propyl]theo-
phylline (xanthinol)
136.Dioxethedrin* and its salts
137.Piprocurarium*138.Propyphenazone*
139.T etrabenazine* and its salts
140.Captodiame*141.Mefeclorazine* and its salts
142.Dimethylamine
143.1,1-Bis(dimethylaminomethyl)propyl benzoate
(amydricaine,
alypine) and its salts
144.Methapyrilene* and its salts
145.Metamfepramone* and its salts
146.Amitriptyline* and its salts
147.Metformin* and its salts76/768/EEC
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18148.Isosorbide dinitrate*
149.Malononitrile
150.Succinonitrile
151.Dinitrophenol isomers152.Inproquone*
153.Dimevamide* and its salts
154.Diphenylpyraline* and its salts155.Sulfinpyrazone*
156.N
-(3-Carbamoyl-3,3-diphenylpropyl)- N,N-diisopropylmethyl-
ammonium salts, e.g. isopropamide iodide*
157.Benactyzine*
158.Benzatropine* and its salts
159.Cyclizine* and its salts160.
5,5-Diphenyl-4-imidazolidone
161.Probenecid*
162.Disulfiram* thiram (ISO)163.Emetine, its salts and derivatives
164.Ephedrine and its salts
165.Oxanamide* and its derivatives166.Eserine or physostigmine and its salts
167.Esters of 4-aminobenzoic acid, with the free amino group,
with the exception of that given in Annex VII, Part
2
168.Choline salts and their esters, e.g. choline chloride
169.Caramiphen* and its salts170.Diethyl 4-nitrophenyl phosphate
171.Metethoheptazine* and its salts
172.Oxpheneridine* and its salts173.Ethoheptazine* and its salts
174.Metheptazine* and its salts
175.Methylphenidate* and its salts176.Doxylamine* and its salts
177.T olboxane*
178.4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol
179.Parethoxycaine* and its salts180.Fenozolone*
181.Glutethimide* and its salts182.Ethylene oxide
183.Bemegride* and its salts
184.V alnoctamide*185.Haloperidol*
186.Paramethasone*
187.Fluanisone*188.Trifluperidol*76/768/EEC
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19189.Fluoresone*
190.Fluorouracil*
191.Hydrofluoric acid, its normal salts, its complexes and hydro-
fluorides with the exception of those given in Annex III,Part 1
192.Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*
193.Galantamine*194.Progestogens, 
195.1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)
196.(1
R,4S,5R,8S)-1,2,3,4,10,10-Hexachlo-
ro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4: 5,8-dimethano-
naphthalene (endrin—ISO)
197.Hexachloroethane198.(1 R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahy-
dro-1,4:5,8-dimethano-naphthalene (isodrin-ISO)
199.Hydrastine, hydrastinine and their salts200.Hydrazides and their salts
201.Hydrazine, its derivatives and their salts
202.Octamoxin* and its salts203.Warfarin* and its salts
204.Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate
and
salts of the acid
205.Methocarbamol*
206.Propatylnitrate*207.4,4’-Dihydroxy-3,3’-(3-methylthiopropylidene)
dicoumarin
208.Fenadiazole*
209.Nitroxoline* and its salts210.Hyoscyamine, its salts and derivatives
211.Hyoscyamus niger L. (leaves, seeds, powder and galenical
preparations)
212.Pemoline* and its salts
213.Iodine
214.Decamethylenebis(trimethylammonium) salts, e.g.
decametho-
nium bromide
215.Ipecacuanha (Cephaelis ipecacuanha Brot. and related
species) (roots, powder and galenical preparations)
216.(2-Isopropylpent.4-enoyl)urea (apronalide)
217.α-Santonin [(3S,5a R,9bS)-3,3a,4,5,5a,9b-hexahy-
dro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]
218.Lobelia inflata L . and its galenical preparations
219.Lobeline* and its salts
220.Barbiturates
221.Mercury and its compounds, except those special cases in-
cluded in Annex VI, Part 1
222.3,4,5- Trimethoxyphenethylamine and its salts
223.Metaldehyde
224.2-(4-Allyl-2-methoxyphenoxy)- N,N-diethylacetamide and its
salts76/768/EEC
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20225.Coumetarol*
226.Dextromethorphan* and its salts
227.2-Methyiheptylamine and its salts
228.Isometheptene* and its salts229.Mecamylamine*
230.Guaifenesin*
231.Dicoumarol*232.Phenmetrazine*, its derivatives and salts
233.Thiamazole*
234.3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5
H-pyrano
[3,2-c]-[1] benzopyran-5-one (cyclocoumarol)
235.Carisoprodol*
236.Meprobamate*237.T efazoline* and its salts
238.Arecoline
239.Poldine metilsulfate*240.Hydroxyzine*
241.2-Naphthol
242.1-and 2-Naphthylamines and their salts243.
3-(1-Naphthyl)-4-hydroxycoumarin
244.Naphazoline* and its salts
245.Neostigmine and its salts (e.g. neostigmine bromide*)
246.Nicotine and its salts
247.Amyl nitrites248.Inorganic nitrites, with the exception of sodium nitrite
249.Nitrobenzene
250.Nitrocresols and their alkali metal salts251.Nitrofurantoin*
252.Furazolidone*
253.Propane-1,2,3-triyl trinitrate254.Acenocoumarol*
255.Alkali pentacyanonitrosylferrate (2-)
256.Nitrostilbenes, their homologues and their derivatives257.Noradrenaline and its salts
258.Noscapine* and its salts
159.Guanethidine* and its salts260.Oestrogens, 
261.Oleandrin
262.Chlortalidone*263.Pelletierine and its salts
264.Pentachloroethane
265.Pentaerithrityl tetranitrate*266.Petrichloral*
267.Octamylamine* and its salts
268.Picric acid76/768/EEC
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21269.Phenacemide*
270.Difendoxazine*
271.2-Phenylindan-1,3-dione (phenindione)
272.Ethylphenacemide*273.Phenprocoumon*
274.Fenyramidol*
275.Triamterene* and its salts276.T etraethyl pyrophosphate; TEPP
(ISO)
277.Tritolyl phosphate
278.Psilocybine*279.Phosphorus and metal phosphides
280.Thalidomide* and its salts
281.Physostigma venenosum Balf.
282.Picrotoxin
283.Pilocarpine and its salts
284.α
-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory
threoform (levophacetoperane) and its salts
285.Pipradrol* and its salts
286.Azacyclonol* and its salts287.Bietamiverine*
288.Butopiprine* and its salts
289.Lead and its compounds, with the exception of that
men-
tioned in Annex III, No 55 under the conditions stated
290.Conjine291.Prunus laurocerasus L. (‘cherry laurel water’)
292.Metyrapone*
293.Radioactive substances (
1)
294.Juniperus sabina L. (leaves, essential oil and galenical prep-
arations)
295.Hyoscine, its salts and derivatives296.Gold salts
297.Selenium and its compounds with the exception of selenium
disulphiele under the conditions set out under referenceNo 49 in Annex Ill, Part 1
298.Solanum nigrum L. and its galenical preparations
299.Sparteine and its salts300.Glucocorticoids
301.Datura stramonium L. and its galenical preparations
(1) The presence of natural radioactive substances and of radioactive
substances caused by artificial contamination from the environment
is permitted, provided that the radioactive substances are not en-
riched for the manufacture of cosmetic products and that theirconcentration falls within the limits set in the Directive laying
down the basic standards for the protection of the health of work-
ers and the general public against the dangers arising from ionizingradiations (OJ No 11, 20. 2. 1959, p. 221/59).76/768/EEC
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22302.Strophantines, their aglucones and their respective derivatives
303.Strophantus species and their galenical preparations
304.Strychnine and its salts
305.Strychnos species and their galenical preparations
306.Narcotics, natural and synthetic: All substances listed in
T a b l e sIa n dI Io ft h es i n g l eC o n v e n t i o no nn a r c o t i cd r u g s
signed in New Y ork on 30 March 1961
307.Sulphonamides (sulphanilamide and its derivatives ...)and
their salts obtained by substitution of one or more H-atoms
of the -NH 2groups) and their salts
308.Sultiame*
309.Neodymium and its salts
310.Thiotepa*311.Pilocarpus jaborandi Holmes and its galenical preparations
312.T ellurium and its compounds
313.Xylometazoline* and its
salts
314.T etrachloroethylene
315.Carbon tetrachioride
316.Hexaethyl tetraphosphate317.Thallium and its compounds
318.Thevetia neriifolia Juss. ,g l y c o s i d ee x t r a c t
319.Ethionamide*
320.Phenothiazine* and its compounds
321.Thiourea and its derivatives, with the exception of the one
listed in Annex III, Part 1
322.Mephenesin* and its esters
323.V accines, toxins or serums listed in the Annex to the second
Council Directive of 20 May 1975 on the approximation of
provisions laid down by law, regulation or administrative ac-
tion relating to proprietary medicinal products (OJ No L 147,9. 6. 1975, p. 13)
324.Tranylcypromine* and its salts
325.Trichloronitromethane (chloropicrine)326.2,2,2- Tribromoethanol (tribromoethyl alcohol)
327.Trichiormethine* and its salts
328.Tretamine*329.Gallamine triethiodide*
330.Urginea scilla Stern. and its galenical preparations
331.V eratrine, its salts and galenical preparations332.Schoenocaulon olficinale Lind. (seeds and galenical prepara-
tions)
333.Veratrum Spp . and their preparations
334.Vinyl chloride monomer
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23336.Salts of O-alkyldithiocarbonic acids
337.Y obimbine and its salts
338.Dimethyl sulfoxide*
339.Diphenhydramine* and its salts340.4-tert-Butylphenol
341.4-tert-Butylpyrocatechol
342.Dihydrotachysterol343.Dioxane
344.Morpholine and its salts
345.Pyretbrum album L. and its galenical preparations
346.2-[4-Methoxybenzyl-
N-(2-pyridyl)amino]ethyldimethylamine
maleate
347.Tripelennamine*348.T etrachlorosalicylanilides
349.Dichlorosalicylanilides
350.T etrabromosalicylanilides 
351.Dibromosalicylanilides, 
352.Bithionol*
353.Thiuram monosulphides354.Thiuram disulphides
355.Dimethylformamide
356.4-Phenylbut-3-en-2-one
357.Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for
normal content in natural essences used
358.Furocoumarines (e.g. trioxysalan*, 8-methoxypsoralen, 5-me-
thoxypsoralen) except for normal content in natural essences
used.
In sun protection and in bronzing products, furocoumarines
shall be below 1 mg/kg.
359.Oil from the seeds of Laurus nobilis L .
360.Safrole except for normal content in the natural essences
used and provided the concentration does not exceed:
100 ppm in the finished product,50 ppm in products for dental and oral hygiene, and pro-
vided that Safrole is not present in toothpastes intended spe-
cifically for children
361.5,5’-Di-isopropyl-2,2’-dimethylbiphenyl-4,4’-diyl dihypoiodite
362.3’-ethyl-5’,6’,7,8’-tetrahydro-5’,6’,8,8’-tetramethyl-2’- aceto-
naphthone;
Syn.: 1,1,4,4-tetramethyl-6-ethyl-7-acetyl-1,2,3,4-tetrahydro-
naphthalene (acetyl ethyl tetramethyl tetralin, AETT)76/768/EEC
82/368/EEC
83/368/EEC - - - 88/233/EEC - - - deleted
88/233/EEC - - - deleted
76/768/EEC
95/34/EC
76/768/EEC
82/368EEC
76/768/EEC
82/147/EEC
76/768/EEC - - - I
24363.O-phenylenediamine and its salts
364.4-methyl-m-phenylenediamine and its salts.
365.Aristolochic acid and its salts
366.Chloroform367.2,3,7,8- T etrachlorodibenzo- p-dioxin
368.2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)
369.Pyrithione sodium (INNM)
370.N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide
(captan)
371.2,2’-Dihydroxy-3,3’,5,5’,6,6’-hexachlorodiphenylmethane (he-
xachlorophene)
372.6-(Piperidinyl)-2,4-pyrimidinediamine-3-oxide (Minoxidil) and
its salts and derivatives
373.34’,5- Tribromosalicylanide (T ribromsalan)
374.Phytolacca spp. and their preparations
375.Tretinoin (retinoic acid and its salts)376.1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole — CI
76050) and their
salts
377.1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and their
salts
378.Colouring agent CI 12140
379.Colouring agent CI 26105
380.Colouring agent CI 42555
Colouring agent CI 42555-1Colouring agent CI 42555-2
381.Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A
(INN))
382.Benzoyl peroxide
383.2-Amino.4-nitrophenol
384.2-Amino-5-nitrophenol
385.11 α-Hydroxypregn-4-ene-3,20-dione and its esters
386.Colouring agent CI 42 640
387.Colouring agent CI 13 065388.Colouring agent CI 42 535
389.Colouring agent CI 61 554
390.Antiandrogens with steroid structure391.Zirconium and its compounds, with the exception of the
complexes under reference number 50 in Annex III (Part 1)
and of zirconium lakes, salts and pigments of colouring ag-ents listed with reference number 3 in Annex IV (Part 1)
392.Thyrothricine
393.Acetonitrile394.T etrahydrozoline and its salts83/341/EEC
84/415/EEC
86/179/EEC
88/233/EEC - - - deleted
87/137/EEC
88/233/EEC - - - C2, OJ No L 157, 24. 6. 1988, p. 38
90/121/EEC
90/121/EEC
89/174/EEC
90/121/EEC
76/768/EEC - - - I
25395.Hydroxy-8-quinoline and its sulphate, except for the uses
provided for in No 51 in Annex III, Part 1
396.Dithio-2,2-bispyridine-dioxide 1,1’ (additive with trihydrated
magnesium sulphate) - - - (pyrithione disulphide + magnesiumsulphate)
397.Colouring agent CI 12075 and its lakes, pigments and salts
398.Colouring agent CI 45170 and CI 45170:1399.Lidocaine
400.1,2-epoxybutane401.Colouring agent CI 15585402.Strontium lactate
403.Strontium nitrate
404.Strontium polycarboxylate405.Pramocaine
406.4-ethoxy-m-phenylenediamine and its salts
407.2,4-diaminophenylethanol and its salts408.Catechol
409.Pyrogallol
410.Nitrosamines411.Secondary dialkanolamines
412.4-Amino-2-nitrophenol
413.2-Methyl-m-phenylenediamine
414.4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)

416.Cells, tissues or products of human origin
417.3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*)
418.3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid)
419. (a) the skull, including the brain and eyes, tonsils and spi-
nal cord of:
— bovine animals aged 12 months,
— ovine and caprine animals which are aged over
12 months or have a permanent incissor tootherupted through the gum;
(b) the spleens of ovine and caprine animals and ingredi-
ents derived therefrom.
However, tallow derivatives may be used provided that
the following methods have been used and strictly cer-tified by the producer:
— Transesterification or Hydrolysis at at least:
200˚C, 40 bars (40 000 hPa) for 20 minutes (glyc-
erol and fatty acids and esters),91/184/EEC
92/86/EEC
93/47/EEC
94/32/EC95/34/EC
97/45/EC - - - deleted
95/34/EC
96/41/EC
98/16/EC
76/768/EEC - - - I
26— Saponification with NaOH 12M (glycerol and
soap):
— Batch process: at 95 ˚C for three hours
or
— Continuous process: at 140 ˚C, two bars
(2 000 hPa) for eight minutes or equivalent
conditions.
420.Crude and refined coal tars
421.1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)
422.5- tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).98/16/EC
97/45/EC
98/62/EC
76/768/EEC - - - I
27ANNEX III
PART 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE
RESTRICTIONS AND CONDITIONS LAID DOWN
Restrictions
ConditionsofuseandwarningsReference
numberSubstance
Field of application and/or useMaximum authorized concentra-
tion in the finished cosmetic
productOther limitations and require-
mentsConditions o fuse and warnings
w h i c hm u s tb ep r i n t e do nt h el a -
bel
a b c d e f
1 Boric acid (a) T alcs
(b) Products for oral hy-
giene(a) 5 %
(b) 0,5 %(a) Not to be used in prod-
ucts for children under
three years old(a) Not to be used for
children under three
years of age
(c) Other products (c) 3 %
2a Thioglycollic acid and its
salts(a) Hair waving or
straightening products:(a) (b) (c):
The directions for use drawn
ih il ffiil(a):— Contains thioglycolate 88/233/EEC
— general use —8 % r e a d y f o r u s e
pH 7 to 9,5up in the national or officiallanguage(s) must obligatorily
incorporate the following
sentenses:gy
— Follow the instructions
— Keep out of reach of
children
Forprofessionaluseonly
— professional use —1 1 % r e a d y f o r u s e
pH 7 to 9,5— Avoid contact with eyes
— In the event of contact
with eyes, rinse immedi-
atelywithplentyofwa-—For pro fessional use only
(b) and (c):— Contains thioglycolate
—Followtheinstructions
(b) Depilatories —5 % r e a d y f o r u s e
pH 7 to 12,7atelywithplentyofwa-
ter and seek medical ad-vice
— Wear suitable gloves ((a)
and(c)only)—Followtheinstructions
— Keep out of reach of
children
(c) Other hair-caire prod-
ucts which are re-
moved after applica-
tion—2 % r e a d y f o r u s e
pH 6 to 9,5
The abovementioned per-
centages are calculated as
thioglycollic acidand(c)only)76/768/EEC
82/368/EEC
76/768/EEC - - - I
28Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
2b Thioglycollic acid esters Hair waving or straighten-
ing products:The directions for use drawnup in the national or official
language(s) must obligatorily
incorporate the followingsentences:— Contains thioglycolate
— Follow the instructions
— Keep out of reach of
children88/233/EEC
— general use —8 % r e a d y f o r u s e
pH 6 to 9,5— May cause sensitization
in the event of skin con-
tact
— avoid contact with eyes
— professional use —1 1 % r e a d y f o r u s e
pH 6 to 9,5— In the event of contact
with eyes, rinse immedi-
a t e l yw i t hp l e n t yo fw a -
ter and seek medical ad-vice— For professional use only C2, OJ No L 157, 24. 6. 1988,p. 38.
The abovementioned per-centages are calculated as
thioglycollic acid—W e a r s u i t a b l e g l o v e s
3 Oxalic acid, its esters and
alcaline saltsHair care products 5% For professional use only 82/368/EEC
4 Ammonia 6 % calculated as NH 3 Above 2 %: contains ammo-
nia
5 T osylchloramide sodium (*) 0-2 %
6Chlorates of alkali metals (a) T oothpaste
(b) Other uses(a) 5 %(b) 3 %82/368/EEC
76/768/EEC - - - I
29Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
7 Dichloromethane 35 % (when mixed with
1,1,1 -trichloroethane, total
concentration must not ex-
ceed 35 %)0·2 % as maximum impuritycontent
8 m- and p-Phenylenedia-
mines, their N-substituted
derivativesandtheirsalts;Oxidizing colouring agentsf o rh a i rd y e i n g 6 % calculated as free base 83/341/EEC
derivatives an dtheirsalts;
N-substituted derivatives
of o-phenylenediamines (1)(a) general use (a) Can cause an allergic
reaction. Contains
phenylenediamines. Do
not use to dye eyelashesor eyebrows92/86/EEC - - - deleted
(b) professional use (b) For professional use
only. Contains phenyle-
nediamines. Can cause
an allergic reaction.
Wear suitable gloves.92/86/EEC - - - deleted93/47/EEC
9
Methylphenylenediamines,
their N-substituted derivat-
tivesandtheirsalts(1)Oxidizing colouring agentsf o rh a i rd y e i n g 10 % calculated as free base 83/341/EEC
tives an dtheirs a lts(1)
with the exeption of sub-
stance No 364 in Annex II(a) general use (a) Can cause an allergic
reaction. Contains
phenylenediamines. Do
not use to dye eyelashesor eyebrows92/86/EEC - - - deleted.
(b) professional use (b) For professional use
only. Contains phenyle-
nediamines. Can cause
en allergic reaction.
Wear suitable gloves.92/86/EEC - - - deleted93/47/EEC82/368/EEC
76/768/EEC - - - I
30Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
10 Diaminophenols (1) Oxidizing colouring agents
f o rh a i rd y e i n g10 % calculated as free base
(a) general use (a) Can cause an allergic
reaction. Contains
diaminophenols. Do not
use to dye eyelashes oreyebrows92/86/EEC - - - deleted
(b) professional use (b) For professional use
only. Contains diamino-
phenols. Can cause aller-
gic reaction.
Wear suitable gloves.92/86/EEC - - - deleted93/47/EEC
11 Dichlorophen (*) 0,5 % 87/137/EEC
12 Hydrogen peroxide, andother compounds or mix-
tures that release hy-
drogen peroxide, includingcarbamide peroxide and
zinc peroxide(a) Hair-caire preparations 12 % of H 2O2(40 volumes),
present or released(a):Wear suitable gloves 92/86/EEC - - - 93/47/EEC
(b) Skin-care preparations 4% o f H 2O2present or re-
leased(b) (c):Contains hydrogen peroxide.
(c) Nail hardening prepa-
rations2% o f H 2O2present or re-
leasedAvoid contact with eyes.Rinse immediately if product
comes into contact with
them
(d) Oral hygiene products 0,1 % of H 2O2present or
released82/368/EEC
76/768/EEC - - - I
31Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
13 Formaldehyde Nail hardeners 5 % calculated as formalde-
hydeProtect cuticles with greaseor oil. Contains formalde-
hyde (
3).
14 Hydroquinone (2) (a) Oxidizing colouring
agent for hair-dyeing:2% (a) 84/415/EEC
1. General use 1. Do not use to dye eye-
dasches or eybrows
Rinse the eyes immedi-ately if the product
comes into contact with
them.Contains hydroquinone
2. Professional use 2. For professional use only
Contains hydroquinone
Rinse the eyes immedi-ately if the product
comes into contact with
them
Hydroquinone (b) Agents for localized
skinlightener2%(b)
skin lightener
— Contains hydroquinone
— Avoid contact with the
eyes
— Apply to small areas
— If irritation develops dis-
continue use82/368/EEC
76/768/EEC - - - I
32Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
—D on o tu s eo nc h i l d r e n
under the age of 12
15a Potassium or sodium hy-droxide (a) Nail cuticule solvent (a) 5 % by weight (4) (a) Contains alkali. Avoid
contact with eyes. Can
cause blindness. Keep
out of reach of children96/41/EC
(b) Hair straightener (b) (b)
1. General use 1. 2 % by weight (4) 1. Contains alkali.
Avoid contact with
eyes. Can cause
blindness. Keep outof reach of children
2. Professional use 2. 4,5 % by weight (4) 2. For professional use
only. Avoid contact
with eyes. Can cause
blindness.
(c) pH adjuster
— depilatories(c) Up to pH 12,7 (c) Keep out of reach of
children. Avoid contact
with eyes
(d) Other uses as pH ad-
juster(d) Up to pH 1182/368/EEC
76/768/EEC - - - I
33Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
15b Lithium hydroxide (a) Hair straightener 96/41/EC
1. General use 1. 2 % by weight (4) 1. Contains alkali. Avoid
contact with eyes. Can
cause blindness. Keep
out of reach of children
2. Professional use 2. 4,5 % by weight (4) 2. For professional use
only. Avoid contact with
eyes. Can cause blind-
ness
(b) Other uses
15c Calcium hydroxide (a) Hair straighteners con-
taining two compo-
nents: calcium hydrox-
ide and a guanidinesalt7 % by weight calcium hy-droxide Contains alkali. Avoid con-tact with eyes. Can cause
blindness. Keep out of reach
of children.
(b) Other uses
16 α-naphtol Colouring agent for hair
dyeing0,5 % Contains α-naphtol 82/368/EEC
17 Sodium nitrite Rust inhibitor 0,2 % Do not use with secondary
and/or tertiary amines or
other substances forming ni-
trosamines
18 Nitromethane Rust inhibitor 0,3 %
19 Phenol and its alkali salts Soaps and shampoos 1 % calculated as phenol Contains phenol
92/86/EEC - - - deleted82/368/EEC
76/768/EEC - - - I
34Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
21 Quinine and its salts (a) Shampoos (a) 0,5 % calculated as qui-
nine base
(b) Hair lotions (b) 0,2 % calculated as qui-
nine base
22 Resorcinol (2) (a) Oxidizing colouring
agent for hair dyeing(a) 5 % (a)
1. general use 1. Contains resorcinol.
Rinse hair well after
application. Do not
use to dye eyelashesor eyebrows.
Rinse eyes immedi-
ately if product
comes into contactwith them
2. professional use 2. For professional use
only. Contains resor-
cinol.
Rinse eyes immedi-
ately if product
comes into contact
with them
(b) Hair lotions and sham-
poos(b) 0,5 % (b) Contains resorcinol
23 (a) Alkali sulphides (a) Depilatories (a) 2 % calculated as sul-
phur pH ±12,7(a) Keep out of reach of
children. Avoid contact
with eyes
(b) Alkaline earth sul-
phides(b) Depilatories (b) 6 % calculated as sul-
phur pH ±12,7(b) Keep out of reach of
children. Avoid contact
with eyes82/368/EEC
76/768/EEC - - - I
35Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
24 Water -soluble zinc salts
with the exception of zinc
4-hydroxy-benzenesulpho-
nate and zinc pyrithione1 % calculated as zinc
25 Zinc 4 -hydroxybenzene
sulphonateDeodorants, antiperspi-rants and astringent lo-
tions6 % calculated as % of an-
hydrous substanceAvoid contact with eyes
26 Sodium monofluorophos-phate Oral hygiene products 0,15 % calculated as F .When mixed with other
fluorine compounds per-
mitted under this Annex, to-tal F concentration must not
exceed 0,15 %Contains ammonium mono-
fluorophosphate
27 Sodium monofluorophos-phate Ditto 0,15 % Ditto Contains sodium monofluo-rophosphate
28 Potassium monofluoro-phosphate Ditto 0,15 % Ditto Contains potassium mono-fluorophosphate
29 Calcium monofluorophos-phate Ditto 0,15 % Ditto Contains calcium monofluo-rophosphate
30 Calcium fluoride Ditto 0,15 % Ditto Contains calcium fluoride
31 Sodium fluoride Ditto 0,15 % Ditto Contains sodium fluoride
32 Potassium fluoride Ditto 0,15 % Ditto Contains potassium fluoride
33 Ammonium fluoride Ditto 0,15 % Ditto Contains ammonium fluo-ride
34 Aluminium fluoride Ditto 0,15 % Ditto Contains aluminium fluoride
35 Stannous fluoride Ditto 0,15 % Ditto Contains stannous fluoride82/368/EEC
76/768/EEC - - - I
36Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
36 Hexadecyl ammonium
fluorideDitto 0,15 % Ditto Contains hexadecyl ammo-nium fluoride
37 3-(N-Hexadecyl -N-2-hydro-
xyethylammonio) propylbis
(2-hydroxyethyl) ammo-
nium difluorideDitto 0,15 % Ditto Contains 3 -(N-Hexadecyl -N-
2-hydroxyethylammonio)
propylbis (2 -hydroxyethyl)
ammonium difluoride
38 NΝ’Ν’-Tris(polyoxyethy -
lene) -N-hexadecylpropyle-
nediamine dihydrofluorideDitto 0,15 % Ditto Contains NΝ’Ν’-tris(polyoxy-
ethylene) -N-hexadecylpropy-
lenediamine dihydrofluoride
39 Octadecenyl -ammonium
fluorideDitto 0,15 % Ditto Contains octadecenyl -ammo-
nium fluoride
40 Sodium fluorosilicate Ditto 0,15 % Ditto Contains sodium fluorosili-cate
41 Potassium fluorosilicate Ditto 0,15 % Ditto Contains potassium fluoro-silicate
42 Ammonium fluorosilicate Ditto 0,15 % Ditto Contains ammonium fluoro-silicate
43 Magnesium fluorosilicate Ditto 0,15 % Ditto Containes (SIC! Contains)magnesium fluorosilicate
44 1,3-Bis (hydroxymethyl)-imidazolidine-2-thione (a) Hair-caire preparations
(b) Nail-care preparations(a) Up to 2 %(b) Up to 2 % (a) Prohibited in aerosol dis-
pensers (sprays)
(b) The pH of the product
as applied must be less
than 4Contains 1,3-bis (hydroxy-
methyl) immidazolidine-2-
thione86/179/EEC
45 Benzyl alcohol Solvents, perfumes and
flavourings82/368/EEC82/368/EEC
76/768/EEC - - - I
37Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
46 6-methylcoumarin Oral hygiene products 0,003 % 83/191/EEC
47 Nicomethanol hydrofluride Oral hygiene products 0,15 % calculated as F
When mixed with other
fluorine compounds per-mitted under this Annex, to-
tal F concentration must not
exceed 0,15 %Contains nicomethanol hy-drofluoride 84/415/EEC
48 Silver nitrate Solely for products in-
tended for colouring eye-
lashes and eyebrows4% — Contains silver nitrate
— Rinse the eyes immedi-
ately if product comesinto contact with them
49 Selenium disulphide Antidandruff shampoos 1% — Contains selenium disul-
phide
— Avoid contact with eyes
or damaged skin85/391/EEC
50 Aluminium zirconium
chloride hydroxyde com-
plexes
AlxZr(OH)yCIz and the
aluminium zirconium chlo-
ride sydroxide glycine
complexesAntiperspirants 20 % as anhydrous alumini-
um zirconium chloride hy-
droxide 5,4 % as zirconium
5,4 % as zirconium1 . T h er a t i oo ft h en u m b e r
of aluminium atoms to
that of zirconium atoms
must be between two an10Do not apply to irritated ordamaged skin
2 . T h er a t i oo ft h en u m b e r
of (Al + Zr) atoms to
that of chlorine atoms
must be between 0,9 and2,1
3. Prohibited in aerosol dis-
pensers (sprays)82/368/EEC
76/768/EEC - - - I
38Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
51 Quinolin-8-old and bis (8-
hydroxy-quinolium) sul-
phateStabilizer for hydrogen
peroxide in rinse-off hair-
care preparations0,3 % calculated as base 88/233/EEC
Stabilizer for hydrogen
peroxide in non-rinse-off
hair-care preparations0,03 % calculated as base
52 Methanol Denaturant for ethanol
and isopropyl alcohol5 % calculated as a % etha-nol and isopropyl acohol 87/137/EEC
53 Etidronic acid (1-hydro-xyethylidene-di-phosphonic
acidanditssalts)(a) Hair-care 1,5 % expressed as etidronicacid 88/233/EEC - - - 89/174/EEC - - -deleted
ac
idandits salts)
(b) Soap 0,2 % expressed as etidronic
acid
54 1-Phenoxy-propzan-2-ol — Rinse-off products only
— Prohibited in oral hy-
giene products2,0 % As a preservative, see AnnexV I ,P a r t1 ,N o4 382/368/EEC
76/768/EEC - - - I
39Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
55 Lead acetate Only for hair-dyeing 0,6 % calculated in lead Keep away from children.
Avoid all contact with the
eyes. Wash hands after use.
Contains lead acetate. Donot use to dye eyelashes,
eyebrows or moustasches. If
irritation develops, discoun-
tinue use.90/121/EEC
56 Magnesium fluoride Dental hygiene products 0,15 % calculated as F .
When mixed with other
fluorine compounds per-
mitted under this Annex, to-tal F concentration must not
exceed 0,15 %Contains magnesium fluo-
ride91/184/EEC
57 Strontium chloride hexahy-drate (a) T oothpaste 3,5 %, calculated as stron-tium. When mixed with oth-
er permitted strontium prod-
ucts the total strontium con-tent must not exceed 3,5 %Contains strontium chloride.Frequent use by children is
not advisable98/62/EC
(b) Shampoo and face care
products2,1 %, calculated as stron-tium. When mixed with oth-
er permitted strontium prod-
ucts the total strontium con-tent must not exceed 2,1 %82/368/EEC
76/768/EEC - - - I
40Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
58 Strontium acetate hemihy-
drateT oothpaste 3,5 %, calculated as stronti-um. When mixed with other
permitted strontium prod-
ucts the total strontium con-tent must not exceed 3,5 %Contains strontium acetate.Frequent use by children is
not advisable92/86/EEC
59 Tal c: H y d r at ed m ag n es i u m
silicate(a) Powdery products in-
tended to be used for
children under three
years of agea) Keep powder away from
children’s nose and
mouth94/32/ECC4, OJ No L 273, 25. 10.
1994, p. 38.
(b) other products
60 Fatty acid dialkanolamides Maximum dialkanolamine
content: 0,5 %— Do not use with nitrosat-
ing systems92/86/EEC
— Maximum dialkanola-
mine content: 5 % (con-
cerns raw materials)
—M a x i m u m N -nitroso -dial-
kanolamine content:
50μg/kg
— Keep in nitrite -free con-
tainers82/368/EEC
76/768/EEC - - - I
41Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
61 Monoalkanolamines Maximum dialkanolamine
content: 0,5 %— Do not use with nitrosat-
ing systems92/86/EEC
— Minimum purity: 99 %
— Maximum secondary al-
kanolamine content:
0,5 % (concerns raw ma-
terials)
—M a x i m u m N -nitrosodial-
kanolamine content:
50μg/kg
— Keep in nitrite -free con-
tainers
62 Trialkanolamines (a) non -rinse -off products (a) 2,5 % (a) (b):
(b) other products — Do not use with nitrosat-
ing systems
— Minimum purity: 99 %
— Maximum secondary al-
kanolamine content:
0,5 % (concerns raw ma-
terials)
—m a x i m u m N -nitrosodial-
kanolamine content:
50μg/kg
— Keep in nitrate -free con-
tainers82/368/EEC
76/768/EEC - - - I
42Reference
numberConditions of use and warnings
which must be printed on the la-
belRestrictions
SubstanceReference
numberConditions of use and warnings
which must be printed on the la-
belOther limitations and require-
mentsMaximum authorized concentra-
tion in the finished cosmetic
productField of application and/or useSubstance
a f e d c b
63 Strontium hydroxide pH-regulator in depilatory
products3,5 % calculated as stron-t i u m ,m a x .p Ho f1 2 , 7 — Keep out of reach of
children
— Avoid contact with the
eyes94/32/EC
64 Strontium peroxide Rinse-off hair care prepa-
rations professional use4,5 % calculated as stron-tium in the ready-for-use
preparationAll products must meet the
hydrogen peroxide release
requirements— Avoid contact with eyes
— Rinse eyes immediately
if product comes intocontact with them
— For professional use only—W e a r s u i t a b l e g l o v e s
(1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the
maximum level authorized for each of them does not exceed 1.
(2) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the
maximum level authorized for each of them does not exceed 2.
(3) Only if the concentration exceeds 0,05 %.82/368/EEC
(4) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the l i m i t sg i v e ni nc o l u m nd . 96/41/EC82/368/EEC
76/768/EEC - - - I
43Part 2
LIST OF SUBSTANCES PROVISIONALLY ALLOWED
Restrictions
ConditionsofuseandReference
numberSubstanceField of application and/
or useMaximum authorized con-
centration in the finished
cosmetic productOther limitations and re-
quirementsConditions o fuse and
warnings which must be
printed on the labelAllowed until
a b c d e f g
95/34/EC - - - deleted86/199/EEC - - - 88 /667/EEC
76/768/EEC - - - I
44ANNEX IV
PART 1
LIST OF COLOURING AGENTS ALLOWED FOR USE IN
COSMETIC PRODUCTS (1)
Field of application
Column 1 = Colouring agents allowed in all cosmetic products.Column 2 = Colouring agents allowed in all cosmetic products
except those intended to be applied in the vicinity
of the eyes, in particular eye make-up and eye-
make-up remover.
Column 3 = Colouring agents allowed exclusively in cosmetic
products intended not to come into contact with
the mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic
products intended to come into contact only brieflywith the skin.
Colour index
numberorde- ColourField of application
Otherlimitationsandrequirements(2) number or de-
nominationColour
1 2 3 4Other limitations and requirements (2)
10006 Green X
10020 Green X
10316 (3) Yellow X
11680 Y ellow X
11710 Y ellow X
11725 Orange X
11920 Orange X
12010 Red X
91/184/EEC - - - deleted
12085 (3)R e d X 3 % maximum concentration in the fin-
ished product
12120 Red X
12150 Red X
12370 Red X
12420 Red X
12480 Brown X
12490 Red X
12700 Y ellow X 89/174/EEC - - - deleted
13015 Y ellow X E1 0 5
88/233/EEC - - - deleted
14270 Orange X E1 0 3
14700 Red X
14720 Red X E1 2 2
14815 Red X E1 2 5
15510 (3)O r a n g e X
15525 Red X76/768/EEC
86/179/EEC - - - 88 /667/EEC
76/768/EEC - - - I
45Colour index
number or de-
nominationOther limitations and requirements (2)Field of application
ColourColour index
number or de-
nominationOther limitations and requirements (2)
4 3 2 1Colour
15580 Red X
91/184/EEC - - - deleted
15620 Red X
15630 (3)R e d X 3 % maximum concentration in the fin-
ished product
15800 Red X 89/174/EEC - - - deleted
15850 (3)R e d X
15865 Red X
15880 Red X
15980 Orange X E1 1 1
15985 (3) Yellow X E1 1 0
16035 Red X
16185 Red X E1 2 3
16230 Orange X
16255 (3)R e d X E1 2 4
16290 Red X E1 2 6
17200 (3)R e d X 90/121/EEC
18050 Red X
18130 Red X
18690 Y ellow X
18736 Red X
18820 Y ellow X
18965 Y ellow X
19140 (3) Yellow X E1 0 2
20040 Y ellow X maximum 3,3’ -dimethylbenzidine con-
centration in the colouring agent: 5 ppm
20170 Orange X
20470 Black X 89/174/EEC - - - deleted
21100 Y ellow X maximum 3,3’ -dimethylbenzidine con-
centration in the colouring agent: 5 ppm
21108 Y ellow X ditto
21230 Y ellow X
24790 Red X
26100 Red X Purity criteria:
aniline±0,2 %
2-naphtol ±0,2 %
4-aminoazobenzene ±0,1 %
1-(phenylazo)-2-naphtol ±3%
1-[2-(phenylazo)phenylazo]-2-napthalenol
±2%92/86/EEC86/179/EEC
76/768/EEC - - - I
46Colour index
number or de-
nominationOther limitations and requirements (2)Field of application
ColourColour index
number or de-
nominationOther limitations and requirements (2)
4 3 2 1Colour
27290 (3)R e d X E1 5 2
27755 Black X E1 5 2
28440 Black X E1 5 1
40215 Orange X
40800 Orange X
40820 Orange X E1 6 0e
40825 Orange X E1 6 0f
40850 Orange X E1 6 1z
42045 Blue X 90/121/EEC - - - 90/121/EEC - - -
deleted
42051 (3)B l u e X E1 3 1
42053 Green X
42080 Blue X X
42090 Blue
42100 Green X
42170 Green X 89/174/EEC - - - deleted
42510 Violet X
42520 Violet X 5 ppm maximum concentration in the
finished product
90/121/EEC - - - deleted
42735 Blue X
44045 Blue X 90/121/EEC - - - 90/121/EEC - - -
deleted
44090 Green X E1 4 2
45100 Red X
91/184/EEC - - - deleted
91/184/EEC - - - deleted
45190 Violet X 89/174/EEC - - - deleted
45220 Red X
45350 Y ellow X 6 % maximum concentration in the fin-
ished product
45370 (3)O r a n g e X not more than 1 % 2 -(6-hdroxy-3 -oxo-3H-
xanthen -9-y1) benzoic acid and 2 % 2 -
(bromo -6-hydroxy -3-oxo-3H-xanthen -9-yl)
benzoic acid
45380 (3)R e d X ditto
45396 Orange X when used in lipstick, the colouring agentis allowed only in free acid form and in a
maximum concentration of 1 %
45405 Red X not more than 1 % 2 -(6-hydroxy -3-oxo-3Η
xanthen -9-yl) benzoic acid and 2 % 2 -
(bromo -6-hydroxy -3-oxo-3H-xanthen -9-yl)
benzoic acid86/179/EEC
76/768/EEC - - - I
47Colour index
number or de-
nominationOther limitations and requirements (2)Field of application
ColourColour index
number or de-
nominationOther limitations and requirements (2)
4 3 2 1Colour
45410 (3)R e d X ditto
45425 Red X not more than 1 % 2 -(6-hydrxy -3-oxo-
3H-xanthen -9-yl) benzoic acid and 3 %
2-(iodo -6-hydroxy -3-oxo-3H-xanthen -9-yl)
benzoic acid
45430 (3)R e d X E 127 ditto
47000 Y ellow X 89/174/EEC - - - deleted
47005 Y ellow X E1 0 4
50325 Violet X
50420 Black X
51319 Violet X
58000 Red X
59040 Green X
60724 Violet X
60725 Violet X
60730 Violet X
61565 Green X
61570 Green X
61585 Blue X
62045 Blue X
69800 Blue X E1 3 0
69825 Blue X
71105 Orange X
73000 Blue X
73015 Blue X E1 3 2
73360 Red X
73385 Violet X
73900 Violet X 92/86/EEC - - - deleted
73915 Red X
74100 Blue X
74160 Blue X
74180 Blue X 92/86/EEC - - - deleted
74260 Green X
75100 Y ellow X
75120 Orange X E1 6 0b
75125 Y ellow X E1 6 0d
75130 Orange X E1 6 0a
75135 Y ellow X E1 6 1d
75170 White X
75300 Y ellow X E1 0 086/179/EEC
76/768/EEC - - - I
48Colour index
number or de-
nominationOther limitations and requirements (2)Field of application
ColourColour index
number or de-
nominationOther limitations and requirements (2)
4 3 2 1Colour
75470 Red X E1 2 0
75810 Green X E 140 and E 141
77000 White X E1 7 3
77002 White X
77004 White X
77007 Blue X
77015 Red X
77120 White X
77163 White X
77220 White X E1 7 0
77231 White X
77266 Black X
77267 Black X
77268:1 Black X E1 5 3
77288 Green X free from chromate ion 87/137/EEC
77289 Green X free from chromate ion
77346 Green X 86/179/EEC
77400 Brown X
77480 Brown X E1 7 5
77489 Orange X E1 7 2
77491 Red X E1 7 2
77492 Y ellow X E1 7 2
77499 Black X E1 7 2
77510 Blue X free from cyanide ions
77713 White X
77742 Violet X
77745 Red X
77820 White X E1 7 4
77891 White X E1 7 1
77947 White X
Lactoflavin Yellow X E1 0 1
Caramel Brown X E1 5 0
Capsanthin,
capsorubinOrange X E1 6 0g
Beetroot red Red X E1 6 2
Anthocyanins Red X E1 6 286/179/EEC
76/768/EEC - - - I
49Colour index
number or de-
nominationOther limitations and requirements (2)Field of application
ColourColour index
number or de-
nominationOther limitations and requirements (2)
4 3 2 1Colour
Aluminium,
zinc, magne-
sium and cal-
cium stearatesWhite X
Bromothymol
blueBlue X
Bromocresol
greenGreen X
Acid red 195 Red X 88/233/EEC
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded
under Annex V from the scope of this Directive are equally allowed.
(2) Colouring agents whose number is preceded by the letter ’E’ in accordance whith the EEC Directive of
1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in thoseDirectives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directiveconcerning colouring matters where the letter ’E’ has been deleted therefrom.
(
3) The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall
also be permitted. They must pass the test for insolubility which will be determined by the procedure laid
down in Article 8.86/179/EEC86/179/EEC
76/768/EEC - - - I
50PART 2
LIST OF COLOURING AGENTS PROVISIONALLY AL-
LOWED FOR USE IN COSMETIC PRODUCTS (1)
Field of application
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products
except those intended to be applied in the vicinityof the eyes, in particular eye make-up and eye
make-up remover
Column 3 = Colouring agents allowed exclusively in cosmetic
products intended not to come into contact with
the mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic
products intended to come into contact only briefly
with the skin.
Colour index
numberor ColourField of applicationOther limitations and re- Authorizationnumber or
denominationColour
1 2 3 4Otherlimitationsandre
quirementsAuthorization
valid until
92/86/ΕE C --- d e l e t e d
(1)Lakes or salts of these colouring agents using substances not prohibited under
Annex II or not excluded under Annex V from the scope of this Directive areequally allowed.86/179/EEC
76/768/EEC - - - I
51ANNEX V
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF
THE DIRECTIVE
5. Strontium and its compounds, with the exception of stron-
tium lactate, strontium nitrate and strontium polycarboxy-
late listed in Annex II, strontium sulphide, strontium chlor-ide, strontium acetate, strontium hydroxide, strontium pe-
roxide, under the conditions laid down in Annex III, Part 1
and of strontium lakes, pigments and salts of the colouringagents listed with the reference (
3) in Annex IV , Part 1.76/768/EEC
90/121/EEC - - - deleted
87/137/EEC - - - deleted90/121/EEC - - - deleted
83/341/EEC - - - deleted
94/32/EC
90/121/EEC - - - deleted
91/184/EEC - - - deleted90/121/EEC - - - deleted
86/179/EEC - - - deleted
84/415/EEC - - - deleted
76/768/EEC - - - I
52ANNEX VI
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS
MAY CONTAIN
PREAMBLE
1. Preservatives are substances which may be added to cos-
metic products for the primary purpose of inhibiting the de-
velopment of micro-organisms in such products.
2. The substances marked with the symbol (*) may also be
added to cosmetic products in concentration other than
those laid down in this Annex for other specific purposesapparent from the presentation of the products, e.g. as de-
odorants in soaps or as anti-dandruff agents in shampoos.
3. Other substances used in the formulation of cosmetic prod-
ucts may also have anti-microbial properties and thus help
in the preservation of the products, as, for instance, many
essential oils and some alcohols. These substances are notincluded in this Annex.
4. For the purposes of this list:
— “Salts” is taken to mean: salts of the cations sodium,
potassium, calcium, magnesium, ammonium and etha-
nolamines; salts of the anions chloride, bromide, sul-
phate, acetate.
— “Esters” is taken to mean: esters of methyl, ethyl, pro-
pyl, isopropyl, butyl, isobutyl, phenyl.
5. All finished products containing formaldehyde or substances
in this Annex and which release formaldehyde must be la-
belled with the warning “contains formaldehyde” where theconcentration of formaldehyde in the finished product ex-
ceeds 0,05 %.86/199/EEC
76/768/EEC - - - I
53PART 1
LIST OF PRESERVATIVES ALLOWED
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which
must be printed on the label
a b c d e
1 Benzoic acid, its salts and esters (*) 0,5 % (acid)
2 Propionic acid and its salts (*) 2%( a c i d )
3 Salicylic acid and its salts (*) 0,5 % (acid) Not to be used in preparations
for children under three years of
age, except for shampoosNot to be used for children under
three years of age (1)
4 Sorbic acid (hexa -2,4-dienoic acid) and
its salts (*)0,6 % (acid)
5 Formaldehyde paraformaldehyde 0,2 % (except for products fororal hygiene)
0,1 % (products for oral hygiene)0,2 % expressed as the phenolProhibited in aerosol dispensers
(sprays)
87/137/EEC - - - deleted
7 Biphenyl -2-ol (o -phenylphenol) and its
salts (*)0,2 % expressed as the phenol
8 Pyrithione zinc (INN) (*) 0,5 % Authorized in products rinsed offForbidden in products for oral hy-
giene
9 Inorganic sulphites and hydrogen- sul-
phites (*)0,2 % expressed as free SO 2
10 Sodium iodate 0,1 % Rinse -off products only
11 Chlorobutanol (INN) 0,5 % Prohibited in aerosol dispensers
(sprays)Contains chlorobutanol
(1)Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.86/199/EEC
76/768/EEC - - - I
54Reference
numberConditions of use and warnings which
must be printed on the labelLimitations and requirements Maximum authorized concentration Substance
a e d c b
12 4 -Hydroxybenzoic acid and its salts and
esters (*)4 % (acid) for 1 ester,
0,8 % (acid) for mixtures of esters
13 3-Acetyl -6-methylpyran -2,4 (3H) -dione
(Dehydracetic acid) and its salts0,6 % (acid) Prohibited in aerosol dispensers(sprays)
14 Formic acid and its sodium salt (+) 0,5 % (expressed as acid) 94/32/EC
15 3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-benzamidine (Dibromohexamidine) and
its salts (including isethionate)0,1 % 86/199/EEC
16 Thiomersal (INN) 0,007 % (of Hg)
If mixed with other mercurial
compounds authorized by this Di-rective, the maximum concentra-
tion of Hg remains fixed at
0,007 %For eye make -up and eye make -
up remover onlyContains thiomersal
17 Phenylmercuric salts (including borate) Ditto Ditto Contains phenylmercuric com-pounds
18 Undec -10-enoic acid and salts (*) 0,2 % (acid) See Annex VI, Part 2, No 8
19 Hexetidine (INN) (*) 0,1 % 88/233/EEC - - - deleted
20 5-Bromo -5-nitro -1,3-dioxane 0,1 % Rinse -off products only
Avoid formation of nitrosamines
89/174/EEC - - - deleted
21 Bronopol (INN) (*) 0,1 % Avoid formation of nitrosamines
22 2,4-Dichlorobenzyl alcohol (*) 0,15 %86/199/EEC
76/768/EEC - - - I
55Reference
numberConditions of use and warnings which
must be printed on the labelLimitations and requirements Maximum authorized concentration Substance
a e d c b
23 Triclocarban (INN) (*) 0,2 % Purity criteria:
3,3’,4,4’ -T etrachloroazobenzene
<1 ppm
3,3’,4,4’ -T etrachloroazoxybenzene
<1 ppm
24 4-Chloro -m-cresol (*) 0,2 % Prohibited in the products in-
tended to come into contact with
mucous membranes
25 Tricolosan (INN) (*) 0,3 %
26 4-Chloro -3,5-xylenol (*) 0,5 %
27 3,3’ -Bis (1 -hydroxymethyl -2,5-dioxoimida-
zolidin -4-yl)-1,14 -methylenediurea
(“Imidazolidinyl urea”) (*)0,6 %
28 Poly (1 -hexamethylenebiguanide hydro-
chloride (*)0,3 %
29 2-Phenoxyethanol (*) 1,0 %
30 Hexamethylenetetramine (*) (methena-
mine) (INN)0,15 %
31 Methenamine 3 -chloroallylochloride
(INNM)0,2 %
32 1-(4-Chlorophenoxy) -1-(imida-
zol-1-yl)-3,3 -dimethylbutan -2-one (*)0,5 %
33 1,3-Bis (hydroxymethyl) -5,5-dimethylimi-
dazolidine -2,4-dione (*)0,6 %
34 Benzyl alchohol (*) 1,0 %
35 1-Hydroxy -4-methyl -6(2,4,4 -trimethylpen-
tyl) 2 -pyridon and its monoethanolamine
salt (*)1,0 %
0,5 %Products rinsed offFor other products
36 1,2-Dibromo-2,4-dicyanobutane 0,1 % Not to be used in cosmetic sun-
screen products at a concentration
exceeding 0,025 %92/86/EEC86/199/EEC
76/768/EEC - - - I
56Reference
numberConditions of use and warnings which
must be printed on the labelLimitations and requirements Maximum authorized concentration Substance
a e d c b
37 6,6-Dibromo-4,4-dichloro2,2‘-methylene-
diphenol (Bromochlorophen) (*)0,1 %
38 4-Isopropyl -m-cresol 0,1 %
39 Mixture of 5 -Chloro -2-methyl -isothiazol -
3(2H) -one and 2 -methylisothiazol -3(2H) -
one with magnesium chloride and magne-
sium nitrate0,0015 % (of a mixture in the ra-
tio 3:1 of 5 -chloro -2-methyliso-
thiazol 3(2H) -one and 2 -methyli-
sothiazol -3( 2 H ) -one89/174/EEC
40 2-Benzyl-4-chlorophenol (clorophene) 0.2 % 87/137/EEC
41 2-Chloroacetamide 0,3 % Contains chloroacetamide 88/233/EEC
42 Chlorhexidine (INN) and its digluconate,
diacetate and dihydrochloride (+)0,3 % expressed as clorhexidine
43 1-Phenoxypropan -2-ol 1,0 % Only for rinse -off products
44 A l k y l( C 1 2 - C 2 2 )t r i m e t h y la m m o n i u m ,
bromide and chloride (*)0,1 % 91/184/EEC
45 4,4-dimethyl-1,3-oxizalidine 0,1 % The pH of the finished product
must not be lower than 6
46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N’-(hy-
droxymethyl) urea0,5 %
47 1,6-Di (4-amidinophenoxy)-n-hexane
(Hexamidine) and its salts (including ise-
thionate and p-hydroxybenzoate) (+)0,1 % 92/86/EEC86/199/EEC
76/768/EEC - - - I
57Reference
numberConditions of use and warnings which
must be printed on the labelLimitations and requirements Maximum authorized concentration Substance
a e d c b
48 Glutaraldehyde (Pentane-1,5-dial) 0,1 % Prohibited in aerosols (sprays) Contains glutaraaldehyde (where
glutaraldehyde concentration in
the finished product exceeds
0,05 %)94/32/EC
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] oc-
tane0,3 % Prohibited in oral hygiene prod-ucts and in products intended to
come into contact with mucous
membranes
50 3-(p-chlorophenoxy)-propane-1,2 diol(chlorphenesin) 0,3 % 96/41/EC
51 Sodium hydroxymethylamino acetate (So-
dium Hydroxymethylglycinate)0,5 %
52 Silver chloride deposited on titaniumdioxide 0,004 % calculated as AgCI 20 % AgCI (W/W) on TiO 2.P r o -
hibited in products for children
under three years of age, in oral
hygiene products and in productsintended for application around
the eyes and on the lips
53 Benzethonium chloride 0,1 % Rinse-off products only 97/45/EC
54 Belzalkonium chloride, bromide and sac-
charinate (+)0,1% calculated as benzalkoniumchloride Not for oral hygiene and lip prod-ucts 98/62/EC86/199/EEC
76/768/EEC - - - I
58PART 2
LIST OF PRESERVATIVES PROVISIONALLY ALLOWED
Reference
numberSubstanceMaximum authorized con-
centrationLimitations and requirementsConditions of use and warn-
ings which must be printed
on the labelAllowed until
a b g d e f
89/174/EEC - - - deleted
96/41/EC - - - deleted
89/174/EEC - - - deleted
91/184/EEC - - - deleted
89/174/EEC - - - deleted
91/184/EEC - - - deleted
88/233/EEC - - - deleted
87/137/EEC - - - deleted
88/233/EEC - - - deleted
87/137/EEC - - - deleted
88/233/EEC - - - deleted
95/34/EC - - - deleted
98/62/EC - - - deleted
91/184/EEC - - - deleted
88/233/EEC - - - deleted
89/174/EEC - - - deleted
92/86/EEC - - - deleted
21 Benzylhemiformal 0,03 % For rinse-off products only 30. 6. 1999 94/32/EC - - - 98/62/EC
88/233/EEC - - - deleted86/199/EEC
76/768/EEC - - - I
59Reference
numberAllowed untilConditions of use and warn-
ings which must be printed
on the labelLimitations and requirementsMaximum authorized con-
centrationSubstance
a f e d g b
89/174/EEC - - - deleted
94/32/EC - - - deleted
29 3-lodo-2-propynyl butylcarbamate (iodo-
propynyl butylcarbamate)0,05 % Not for oral hygiene and lip prod-ucts 30. 6. 1999 98/62/EC
96/41/EC - - - deleted86/199/EEC
76/768/EEC - - - I
60ANNEX VII
List of UV filters which cosmetic products may contain
For the purposes of this Directive, UV filters are substances which, contained in cosmetic sun-screen
products, are specifically intended to filter certain UV rays in order to protect the skin from certainharmful effects of these rays.
These UV filters may be added to other cosmetic products within the limits and under the conditions
laid down in this Annex.
Other UV filters used in cosmetic products solely for the purpose of protecting the product against
UV rays are not included in this list.
PART 1
List of permitted UV filters which cosmetic products may contain
Reference
NoSubstancesMaximum
authorized
concentrationOther
limitations
and
requirementsConditions of use
and warnings
which must be
printed on the
label
a b c d e
14 -Aminobenzoic acid 5%
2 N,N,N -Trimethyl -4-(2-oxoborn -3-ylide-
nemethyl) anilinium methyl sulphate6%
3 Homosalate (INN) 10 %
4 Oxybenzone (INN) 10 % Contains oxy-benzone (
1)
93/47/EEC - - - deleted
6 2-phenylbenzimidazole -5-sulphonic acid
and its potassium, sodium and trietha-nolamine salts8%
(expressed as
acid)
7 3,3’-(1,4-Phenylenedimethylene) bis (7,7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-yl-methanesulfonic acid and its salts 10 %
(expressed as
acid)94/32/EC
8 1-(4-tert-butylphrnyl)-3-(4-methoxyphe-nyl)propane-1,3-dione 5% 93/47EEC
9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts 6%
(expressed as
acid)94/32/EC
10 2-cyano-3,3-diphenyl acrylic acid,2-ethylhexyl ester (Octocrylene) 10 %
(expressed as
acid)95/34/EC
11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide 6% 96/41/EC
12 Octyl methoxycinnamate 10 % 97/45/EC83/574/EEC
76/768/EEC - - - I
61Reference
NoConditions of use
and warnings
which must be
printed on the
labelOther
limitations
and
requirementsMaximum
authorized
concentrationSubstances
a e d c b
13 Ethoxylated Ethyl-4-Aminobenzoate
(PEG-25 PABA)10 % 98/62/EC
14 Isopentyl-4-methoxycinnamate (Isoamyl
p-Methoxycinnamate)10 %
15 2,4,6- Trianilino-(p-Carbo-2‘-Ethylhexyl-1‘Oxy)-1,3,5- Triazine (Octyl Triazone) 5%
16 Phenol,2-(2H-Benzotria-zol-2-yl)-4-Methyl-6-(2-Meth-yl-3-(1,3,3,3- T etra-methyl-I-(Trimethylsi-lyl)Oxy)-Disilo-xanyl)Propyl) (Drome-trizole Trisiloxane)15 %
17 Benzoic acid, 4,4-((6-(((1,1-dimethyl-ethyl)amino)carbonyl)phenyl)amino)1,3,5-triazine-2,4-diyl)diimino)bis-,bis-(2-ethylhexyl)ester)10 %
18 3-(4‘-Methylbenxylidene)-d-1 camphor(4-Methylbenzylidene Camphor) 4%
19 3-Benzylidene camphor (3-BenzylideneCamphor) 2%
20 2-Ethylhexyl salicylate (Octyl-salicylate) 5%
(1) Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.
76/768/EEC - - - I
62PART 2
LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN
Reference
numberSubstancesMaximum
authorized
concentrationOther
limitations
and
requirementsConditions of use
and warnings which
must be printed on
the labelAllowed until
a b c d e f
92/86/EEC - - - deleted
98/62/EC - - - deleted
92/86/EEC - - - deleted
5 2-Ethylhexyl 4-dimethylamino-
benzoate8% 30. 6. 1999 98/62/EC
98/62/EEC - - - deleted
98/62/EEC - - - deleted
97/45/EC - - - deleted
92/86/EEC - - - deleted
17 2-Hydroxy-4-methoxybenzophe
none-5 sulphonic acid andsodium salt (Sulisobenzoneand Sulisobenzone sodium)5%
(expressed
as acid)30. 6. 1999 98/62/EC
94/32/EC - - - deleted
98/62/EC - - - deleted
98/62/EC - - - deleted
94/32/EC - - - deleted
29 4-Isopropylbenzyl salicylate 4% 30. 6. 1999 98/62/EC
93/47/EEC - - - deleted
98/62/EC - - - deleted
96/41/EC - - - deleted89/174/EEC
76/768/EEC - - - I
63ANNEX VIII
 93/35/EEC