Methods of analysis

European Union

Description

Health policy

Sujets

• Consumer protection
• Health law
• Health care system
• Public health

Informations

• Publié par: EUROPEAN-UNION
• Nombre de lectures: 342
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

The rules governing cosmetic products
in the European Union
etLex
Volume 2
Cosmetics
legislation
Cosmetic products
Methods of analysis
■
II
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EUROPEAN COMMISSION A great deal of additional information on the European Union is available on the Internet.
It can be accessed through the Europa server (http://europa.eu.int).
Cataloguing data can be found at the end of this publication.
Luxembourg: Office for Official Publications of the European Communities, 2000
ISBN 92-828-8546-1
© European Communities, 2000
Reproduction is authorised, provided the source is acknowledged.
Printed in Belgium The rules governing cosmetic products
in the European Union
Volume 2
Cosmetics legislation
Cosmetic products
Methods of analysis
2000 Edition
EUROPEAN COMMISSION
Enterprise Directorate-General
Pharmaceuticals and cosmetics THE RULES GOVERNING COSMETIC PRODUCTS
IN THE EUROPEAN UNION
Volume 1 Cosmetics legislation
Cosmetic products
Volume 2 Methods of analysis
Cosmetic products
Volume 3 Guidelines
Cosmetic products FOREWORD
In the early 1970's, the Member States of the EU decided to harmonise their national cosmetic
regulations in order to enable the free circulation of cosmetic products within the Community. As
a result of numerous discussions between experts from all Member States, Council Directive
76/768/EEC was adopted on 27 July 1976. The principles laid down in the Cosmeticse
take into account the needs of the consumer while encouraging commercial exchange and
eliminating barriers to trade. For example, if a product is to move freely within the EU, the same
labelling, packaging and safety regulations must apply. This is one of the main objectives of the
Cosmetics Directive: to give clear guidance on what requirements a safe cosmetic product should
fulfil in order to freely circulate within the EU, without pre-market authorisation. The Cosmetics
Directive aims to guarantee the safety of cosmetic products for human use. This safety relates to
composition, packaging and information and it falls totally under the responsibility of the
producer or the importer into the EU who is responsible for the marketing liability. There is no
pre-market control for cosmetic products at Member State or EU level. Control of cosmetic
products within the EU is assured through the responsibility of the person who places the product
on the market, a simple notification of manufacturing/importing site, and an in-market
surveillance system.
Volume 2 of the series entitled "The Rules governing cosmetic products in the European Union"
incorporates the seven Commission Directives on the approximation of the laws of the Member
States relating to methods of analysis necessary for checking the composition of cosmetic
products.
Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of
ensuring that the conditions prescribed pursuant to Community provisions concerning the
composition of the cosmetic products are satisfied. Effective in-market control by Member States
ensures that onlycs which conform to the provisions of the Cosmetics Directive
and its Annexes are on the market. Inspectors appointed at national level may visit department
stores, supermarkets, small shops and market stalls to check the products being sold. If
necessary, these inspectors may take any product from the market to official laboratories to be
tested for compliance with EU regulations. Article 8 (1) of Directive 76/768/EEC provides for the
determination of the methods of analysis necessary for checking the composition of cosmetic
products. A certain number of methods of analysis have already been validated at European level
and accepted as official methods and described in seven Commission Directives on the
approximation of the laws of the Member States relating to methods of analysis necessary for
checking the composition of cosmetic products. This means that official testing of cosmetic
products by laboratories of any kind (national, control, etc.) have to be carried out in accordance
with the European official methods described in these Directives.
Commission Directives 80/1335/EEC and 82/434/EEC have already been amended once
respectively by Commission Directive 87/143/EEC and Commission Directive 90/207/EEC. With a
view to facilitating consultation, there are set out here in codified form for internal use by the
competent Commission departments. These codified texts are available to the public but have no
force in law. Where doubts exist, the original texts as published in the Official Journal of the
European Communities, should be consulted.
Ill TABLE OF CONTENTS
FOREWORD Ill
FIRST COMMISSION DIRECTIVE 80/1335/EEC 1
First Commission Directive 80/1335/EEC of 22 December 1980 on the approximation of the
laws of the Member States relating to methods of analysis necessary for checking the
composition of cosmetic products
SECOND COMMISSION DIRECTIVE 82/434/EEC 27
Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the laws
of the Member States relating to methods of analysis necessary for checking the
composition of cosmetic products 2
THIRD COMMISSION DIRECTIVE 83/514/EEC 65
Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the
laws of the Member States relating to methods of analysis necessary for checking the
composition of cosmetic products 6
FOURTH COMMISSION DIRECTIVE 85/490/EEC 10
Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the
laws of the Member States relating to methods of analysis necessary for checking the
composition of cosmetic products 105
FIFTH COMMISSION DIRECTIVE 93/73/EEC 129
Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis
necessary for checking composition of cosmetic products
SIXTH COMMISSION DIRECTIVE 95/32/EC 157
Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis
necessary for checking the composition of cosmetic products
SEVENTH COMMISSION DIRECTIVE 96/45/EC 17
Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis
necessary for checking the composition of cosmetic productsFIRST COMMISSION DIRECTIVE 80/1335/EEC
First Commission Directive 80/1335/EEC of 22 December 1980
on the approximation of the laws of the Member States relating
to methods of analysis necessary for checking the composition
of cosmetic products
(As amended by Commission Directive 871143 /EEC of 10 February 1987)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws
of the Member States relating to cosmetic products C1), as amended by Directive 79/661/EEC (2),
and in particular Article 8 ( 1) thereof,
Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim
of ensuring that the conditions prescribed pursuant to Community provisions concerning the
composition of the cosmetic products are satisfied;
Whereas all the necessary methods of analysis must be established as soon as possible; whereas
the laying down of methods for the sampling, laboratory preparation, identification and
determination of free sodium and potassium hydroxides, the identification and determination of
oxalic acid and alkaline salts thereof in hair care products, the determination of chloroform in
toothpastes and of zinc, and the identification and determination of phenosulfonic acid constitutes
a first step in this direction;
Whereas the measures laid down in the present Directive are in conformity with the opinion of
the Committee on the adaptation of Directive 76/768/EEC to technical progress,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Member States shall take all necessary steps to ensure that, in the official testing of cosmetic
products:
— the sampling,
—e laboratory preparation oftest samples,
— the identification and determination of free sodium and potassium hydroxides,
—en andn of oxalic acid and alkaline salts in hair-care
products,
— the determination of chloroform in toothpastes,
—en of zinc,
(1) OJ No L 262, 27. 9. 1976, p. 169.
(2) OJ No L 192, 31. 7. 1979, p. 35. Directive 80/1335/EEC
— the identification and determination of phenolsulfonic acid
are performed in accordance with the methods described in the Annex.
Article 2
Member States shall bring into force the laws, regulations or administrative provisions necessary
to comply with this Directive not later than 31 December 1982.
They shall forthwith inform the Commission thereof.
Article 3
This Directive is addressed to the Member States.
Done at Brussels, 22 December 1980.
For the Commission
Richard BURKE
Member of the Commission