ouncil Directive 76/768/EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to
cosmetic products
Note: The text of the recitals below only covers the recitals included with the original Directive of
1976 and with the 6th Amendment of 1993.
Recitals of original Directive 76/768/EEC
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty 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 Parliament,
Having regard to the opinion of the Economic and Social Committee,
Whereas the provisions laid down by law, regulation or administrative action in force in the
Member States define the 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 Community cosmetic producers to vary their
production according to the Member State for which the products are intended; whereas,
consequently, they hinder trade in these products and, as a result, have a direct effect on the
establishment and functioning of the common market;
Whereas the main objective of these laws is the safeguarding 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 attained 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;
Whereas this Directive relates only to cosmetic products and not to pharmaceutical specialities
and medicinal products; 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 follows 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 products 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 substances listed 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 particular 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 additions which may have to be made to them on the basis of the results of
scientific and technical research, are implementing measures of a technical nature; whereas it is
advisable to entrust their adoption to the Commission, subject 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
establishing 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 sector;
Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for
lists of authorized 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 products placed on the market might endanger public health; whereas it is
therefore advisable to provide for a procedure intended to remove this danger,
Recitals of 6th Amendment – Directive 93/35/EEC
Whereas the legal ambiguities in Directive 76/768/EEC particularly in Articles 1 and 2, should be
removed;
Whereas it has become apparent that it is desirable that data on the ingredients employed in
cosmetic products be gathered so that all issues relating to their use and the resulting action at
Community level may be assessed with a view, in particular, to the establishment of a common
nomenclature of ingredients used in cosmetic products; whereas the gathering of that data can be
facilitated if the Commission compiles an inventory of the ingredients concerned; whereas that
inventory will be indicative and is not intended to constitute a limitative list of substances used
in cosmetic products;
Whereas greater transparency is needed regarding the ingredients employed in cosmetics if the
latter are to be placed on the market without any prior procedure, if the necessary information on
the finished product is to be available solely at the place of manufacture or of initial importation
into the Community and if better information is to be provided to the consumer; whereas such
transparency should be achieved by indication of a product's function and of the ingredients used
in a cosmetic product on its packaging; whereas where for practical reasons it is impossible to
indicate the ingredients and any warnings regarding use on the container or the packaging, such
particulars should be enclosed so that the consumer may have access to all necessary information;
Whereas, with regard to the finished cosmetic product, it should be made clear which information
is to be made available to the monitoring authorities of the place of manufacture or of initial
importation into the Community market; whereas that information should include all the
necessary particulars relating to identity, quality, safety for human health and the effects
claimed for the cosmetic product;
Whereas, however, for reasons of monitoring, the competent authority should be apprised of the
place of manufacture and of the information needed for rapid and appropriate medical treatment
in the event of difficulties;
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