1995L0017 — EN — 01.05.2004 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE95/17/EC
of19June1995
laying down detailed rules for the application of Council Directive 76/768/EEC as regards the
non-inclusionofoneormore ingredientsonthelistusedforthelabelling ofcosmetic products
(TextwithEEArelevance)
(OJ L 140, 23.6.1995, p. 26)
Amended by:
Official Journal
No page date
►A1Act concerning the conditions of accession of the Czech Republic, the
Republic of Estonia, the Republic of Cyprus, the Republic of Latvia,the Republic of Lithuania, the Republic of Hungary, the Republic ofMalta, the Republic of Poland, the Republic of Slovenia and the SlovakRepublic and the adjustments to the Treaties on which the EuropeanUnion is foundedL 236 33 23.9.2003
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COMMISSIONDIRECTIVE95/17/EC
of19June1995
laying down detailed rules for the application of Council Directive
76/768/EEC as regards the non-inclusion of one or more ingredi-
entsonthelistusedforthelabelling ofcosmetic products
(TextwithEEArelevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to cosmeticproducts (
1), as last amended by Commission Directive 94/32/EC (2),
and in particular Article 6 (1) (g) thereof,
Whereas there is a need to specify the criteria and conditions under
which a manufacturer may, for reasons of trade secrecy, apply not toinclude one or more ingredients on the minimum list of ingredients
which must be included on the packaging of cosmetic products, or,
where this is impossible for practical reasons, on an enclosed leaflet,label, tape or card;
Whereas approval of confidentiality should not, however, impinge on
the other obligations pursuant to Directive 76/768/EEC and the respon-sibilities arising from the Articles concerning the cosmetic product'ssafety, from the Annexes, and from the provisions as to the information
necessary for appropriate medical treatment and the case-file to which
the national monitoring authorities must have access;
Whereas approval of confidentiality should not be prejudicial to
consumer safety;
Whereas the request for confidentiality must be submitted in the
Member State of manufacture or initial importation into the Commu-nity market, which must also have access to the information referredto in Article 7a of Directive 76/768/EEC, as amended by Directive
93/35/EEC (
3), for control purposes;
Whereas to be adequately assessed and monitored the request must
include all the particulars necessary for identifying the applicants, forthe identification and human health assessment of the ingredient asused in the cosmetic product(s) and for determining the intended useof the ingredient concerned, as well as the grounds for confidentialityand the name(s) of the product containing the ingredient;
Whereas for economic reasons and in deference to his rights the
competent authority should inform the applicant, within a brief period
of not more than four months, other than in exceptional cases, of theruling in this case; whereas any refusal to grant confidentiality shouldbe duly reasoned and the means of appeal and time limits clearly indi-cated;
Whereas in the interests of transparency and monitoring, the competent
authority should allocate a registration number to each request it
approves; whereas this number should replace the ingredient in the list
of ingredients referred to in Article 6 (1) (g) of Directive 76/768/EEC;
Whereas all amendments to the particulars contained in the initial
request must be communicated by the applicant to the competentauthority, which may then withdraw its approval of confidentiality inview of those modifications, or if new information makes such ameasure necessary for compelling public health reasons;1995L0017 — EN — 01.05.2004 — 001.001 — 2
(1) OJ No L 262, 27. 9. 1976, p. 169.
(2) OJ No L 181, 15. 7. 1994, p. 31.
(3) OJ No L 151, 23. 6. 1993, p. 32.
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Whereas the duration of the right to confidentiality should not exceed
five years, subject to the option, in exceptional circumstances, of anextension for a further three years at the most;
Whereas, in the interests of monitoring product safety and proper
enforcement of the Directive, the Commission and the other MemberStates should be adequately informed of the decisions taken by the
competent authority; whereas, on the other hand, such decisions should
be recognized throughout the Community territory, except for excep-tional reasons;
Whereas the measures provided for in this Directive are in accordance
with the opinion of the Committee on the Adaptation to TechnicalProgress of the Directives on the Removal of Technical Barriers toTrade in the Cosmetics Products Sector,
HAS ADOPTED THIS DIRECTIVE:
Article 1
This Directive shall apply without prejudice to the other obligations
arising from Directive 76/768/EEC and the responsibilities arisingtherefrom, in particular from Articles 2, 4, 5, 7 (3) and 7a thereof.
Article 2
Any manufacturer or his agent or person on whose account a cosmetic
product is manufactured, or any person responsible for placing animported cosmetic product on the Community market, who, for reasons
of trade secrecy, wishes not to include one or more ingredients of a
cosmetic product on the list referred to in Article 6 (1) (g) of Directive76/768/EEC, shall submit a request to that effect to the competentauthority referred to in Article 10 of this Directive of the Member Stateof the place of manufacture or initial importation, prior to placing theproduct on the Community market.
Article 3
The request referred to in Article 2 must include the following particu-
lars:
(a) name or style and address or head office of the applicant;
(b) precise identification of the ingredient for which confidentiality is
requested, namely:
— the CAS, Einecs and colour index numbers, the chemical name,
the Iupac name, the INCI(
1) name, the European Pharmaco-
poeianame, the international non-proprietary name
recommended by the World Health Organization, and thecommon nomenclature name referred to in Article 7 (2) ofDirective 76/768/EEC, where they exist,
— the Elincs name and the official number allocated to it if it has
been notified pursuant to Council Directive 67/548/EEC (
2) and
indication of approval or refusal to approve a request for confi-dentiality pursuant to Article 19 of that Directive,
— where the names or numbers referred to in the first and second
indents do not exist, as in the case of certain ingredients of
natural origin, the name of the base material, the name of thepart of the plant or animal used, and the names of the ingredi-ent's components, suchas solvents;
(c) the evaluation of the safety for human health of the ingredient as
used in the finished product(s), taking into account the ingredient's
toxicological profile, chemical structure and the level of exposure,
as specified in Article 7a (1) (d) and (e) and Article 7a (2) ofDirective 76/768/EEC;1995L0017 — EN — 01.05.2004 — 001.001 — 3
(1) Formerly: CTFA name.
(2) OJ No L 196, 16. 8. 1967, p. 1.
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(d) the envisaged use of the ingredient and in particular the different
categories of products in which it will be used;
(e) a detailed justification of why, by way of exception, confidentiality
is sought; for example:
— the fact that the identity of the ingredient or its function in the
cosmetic product to be marketed has not been described in theliterature and is unknown to others in the trade,
— the fact that the information is not yet in the public domain,
even though a patent application has been lodged for the ingre-
dient or its use,
— the fact that if the information were known it would be easily
reproducible, to the detriment of the applicant;
(f) if known, the name of each product which is to contain the ingre-
dient(s), and if different names are to be used in the Community
market, precise details on eachone of th em.
If the name of a product is not yet known, it may be communicated
at a later date, but at least 15 days before placing the product onthe market.
If the ingredient is used in several products, one request shall
suffice, provided that the products are clearly indicated to the
competent authority;
(g) a statement setting out whether a request has been submitted to the
competent authority of any other Member State in respect of theingredient for which confidentiality is sought, and particulars onthe outcome of any such request.
Article 4
1. After receipt of the request for confidentiality in accordance with
Article 3 the competent authority shall, within a period not exceeding
four months, examine the request and inform the applicant in writing ofits decision. In the event of approval, the authority shall also commu-nicate the registration number it has allocated to the product inaccordance with the procedure laid down in the Annex. However, if
there are exceptional reasons, the competent authority may inform the
applicant in writing that an additional period of two months will berequired for the examination of the request.
2. Any refusal to grant a request for confidentiality must include a
statement of reasons; appeal procedures, together with their time limits,must be clearly explained to the applicant.
Article 5
The registration number referred to in Article 4 (1) shall replace the
ingredient in question in the list referred to in Article 6 (1) (g) ofDirective 76/768/EEC.
Article 6
1. All amendments to the information provided pursuant to Article 3
must be communicated as rapidly as possible to the competentauthority that has granted the request for confidentiality. All changesto the names of cosmetic products containing the ingredient must becommunicated to the competent authority at least 15 days before those
products are placed on the market under their new name.
2. Taking into consideration the amendments referred to in para-
graph1, or if new information makes it imperative to do so,
particularly for compelling reasons of public health, the competent
authority may withdraw its approval. In this event it shall inform theapplicant of its new decision within the time limits and in accordancewithth e procedure referred to in Article 4.
Article 7
The decision granting the right to confidentiality shall be valid for a
period of five years.1995L0017 — EN — 01.05.2004 — 001.001 — 4
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If the beneficiary of this decision considers that there are exceptional
reasons justifying an extension of this period, he may submit areasoned request to the competent authority which initially granted the
request for confidentiality.
The competent authority shall decide on this new request within the
time limits and under the conditions referred to in Article 4.
The confidentiality period shall not be extended by more than three
years.
Article 8
1. Member States shall inform the Commission and the other
Member States of their decisions to grant requests for confidentiality
or to extend suchapproval, indicating th e name or style and address
or head office of the applicants, the names of the cosmetic productscontaining the ingredient in respect of which the request for confidenti-ality has been granted, and the registration number referred to inArticle 4 (1).
The Commission and the other Member States may obtain, on request,
a copy of the case file containing the request for confidentialitytogether with the decision of the competent authority. Particularly inthis framework the competent authorities of the Member States andthe Commission shall make arrangements to ensure proper cooperation.
2. Member States shall inform the Commission and the other
Member States of their reasoned decisions to refuse or to withdraw
approval of confidentiality or to refuse to extend the confidentialityperiod.
3. Member States and the Commission shall take the necessary
measures to ensure that confidential data made known to them is notimproperly disclosed.
Article 9
Member States shall recognize the decisions taken by a competent
authority as to the approval of confidentiality or extension of the confi-
dentiality period.
However, if, after having been informed or after having received a
copy of the case file in accordance with the procedure under Article 8(1), a Member State challenges a decision taken by the competentauthority of another Member State, it may ask the Commission to
take a decision pursuant to the procedure referred to in Article 10 of
Directive 76/768/EEC.
Article 10
Member States shall designate the competent authorities referred to in
this Directive and shall inform the Commission thereof, which shallpublish them in the Official Journal of the European Communities .A
Member State may also designate the competent authority of another
Member State, willing to accept for the purposes of examination in
exceptional cases the requests referred to in Article 2.
Article 11
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply withth is Directive notlater than 30 November 1995. They shall forthwith inform theCommission thereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference
at the time of their official publication. The procedure for such refer-ence shall be adopted by Member States.
2. Member States shall communicate to the Commission the text of
the provisions of national law which they adopt in the field covered bythis Direcitve.1995L0017 — EN — 01.05.2004 — 001.001 — 5
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Article 12
This Directive shall enter into force on the seventh day following its
publication in the Official Journal of the European Communities .
Article 13
This Directive is addressed to the Member States.1995L0017 — EN — 01.05.2004 — 001.001 — 6
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ANNEX
PROCEDURE FOR GRANTING THE REGISTRATION NUMBER
REFERREDTOINARTICLE4
1. The registration number referred to in Article 4 consists of seven digits, the
first two corresponding to the year of approval of confidentiality, the second
two to the code assigned to each Member State pursuant to point 2, and the
three final digits being assigned by the competent authority.
2. The following codes are allocated to the Member States:
01 France
02 Belgium
03 Netherlands
04 Germany05 Italy06 United Kingdom
07 Ireland
08 Denmark09 Luxembourg
10 Greece
11 Spain12 Portugal13 Finland
14 Austria
15 Sweden
16 CzechRepublic
17 Estonia18 Cyprus
19 Latvia
20 Lithuania21 Hungary22 Malta
23 Poland
24 Slovenia25 Slovakia.1995L0017 — EN — 01.05.2004 — 001.001 — 7
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