n tests sur animaux horreur , mensonge = "aucune' cruauté!

c) Si, à l'expiration d'un délai de trois mois à compter de la saisine du Conseil, celui-ci n'a pas statué, les mesures proposées sont arrêtées par la Commission.


Article 11
Sans préjudice des dispositions de l'article 5 et au plus tard un an après l'expiration du délai prévu à l'article 14 paragraphe 1 pour la mise en oeuvre par les États membres de la présente directive, la Commission, sur la base des résultats des dernières recherches scientifiques et techniques, présente au Conseil des propositions appropriées établissant des listes des substances admises.

Article 12
1. Si un État membre constate, sur la base d'une motivation circonstanciée, qu'un produit cosmétique, bien que conforme aux prescriptions de la présente directive, présente un danger pour la santé, il peut provisoirement interdire ou soumettre à des conditions particulières sur son territoire la mise sur le marché de ce produit cosmétique. Il en informe immédiatement les autres États membres et la Commission en précisant les motifs justifiant sa décision.
2. La Commission procède, dans un délai de six semaines, à la consultation des États membres intéressés, puis elle émet sans tarder son avis et prend les mesures appropriées.
3. Si la Commission est d'avis que des adaptations techniques à la présente directive sont nécessaires, ces adaptations sont arrêtées, soit par la Commission, soit par le Conseil, selon la procédure prévue à l'article 10 ; dans ce cas, l'État membre qui a adopté des mesures de sauvegarde peut les maintenir jusqu'à l'entrée en vigueur de ces adaptations.

Article 13
Tout acte individuel, pris en application de la présente directive, portant restriction ou interdiction à la mise sur le marché des produits cosmétiques est motivé de façon précise. Il est notifié à l'intéressé avec l'indication des voies de recours ouvertes par la législation en vigueur dans les États membres et du délai dans lequel ces recours peuvent être présentés.

Article 14
1. Les États membres mettent en vigueur les dispositions nécessaires pour se conformer à la présente directive dans un délai de dix-huit mois à compter de sa notification et en informent immédiatement la Commission.
2. Toutefois, pendant une période de trente-six mois à compter de la notification de la présente directive, les États membres peuvent autoriser la mise sur le marché, sur leur territoire, de produits cosmétiques non conformes aux prescriptions de la présente directive.
3. Les États membres veillent à communiquer à la Commission le texte des dispositions de droit interne qu'ils adoptent dans le domaine régi par la présente directive.

Article 15
Les États membres sont destinataires de la présente directive.


Fait à Bruxelles, le 27 juillet 1976.
Par le Conseil
Le président
M. van der STOEL



ANNEXE I LISTE INDICATIVE PAR CATÉGORIE DES PRODUITS COSMÉTIQUES
- Crèmes, émulsions, lotions, gels et huiles pour la peau (mains, visage, pieds, etc.)
- Masques de beauté (à l'exclusion des produits d'abrasion superficielle de la peau par voie chimique)
- Fonds de teint (liquides, pâtes, poudres)
- Poudres pour maquillage, poudres à appliquer après le bain, poudres pour l'hygiène corporelle, etc.
- Savons de toilette, savons déodorants, etc.
- Parfums, eaux de toilette et eau de Cologne
- Préparations pour bains et douches (sels, mousses, huiles, gels, etc.)
- Dépilatoires
- Déodorants et antisudoraux
- Produits de soins capillaires: - teintures capillaires et décolorants
- produits pour l'ondulation, le défrisage et la fixation
- produits de mise en plis
- produits de nettoyage (lotions, poudres, shampoings)
- produits d'entretien pour la chevelure (lotions, crèmes, huiles)
- produits de coiffage (lotions, laques, brillantines)


- Produits pour le rasage (savons, mousses, lotions, etc.)
- Produits de maquillage et démaquillage du visage et des yeux
- Produits destinés à être appliqués sur les lèvres
- Produits pour soins dentaires et buccaux
- Produits pour les soins et le maquillage des ongles
- Produits pour soins intimes externes
- Produits solaires
- Produits de bronzage sans soleil
- Produits permettant de blanchir la peau
- Produits antirides

ANNEXE II LISTE DES SUBSTANCES QUE NE PEUVENT CONTENIR LES PRODUITS COSMÉTIQUES
1. Acétylamino-2 chloro-5 benzoxazole
2. ß - acétoxyéthyl triméthyl ammonium hydroxyde (acétylcholine) et ses sels
3. Acéglumate de déanol (*)
4. Spironolactone (*)
5. Acide [(hydroxy-4 iodo-3 phénoxy)-4 diiodo-3,5 phényl] acétique (acide 3,3',5 triiodothyroacétique) et ses sels
6. Méthotrexate (*)
7. Acide aminocaproïque (*) et ses sels
8. Cinchophène (*), ses sels, dérivés et les sels de ses dérivés
9. Acide thyropropique (*) et ses sels
10. Acide trichloracétique
11. Aconitum napellus L. (feuilles, racines et préparations)
12. Aconitine (alcaloïde principal d'Aconitum napellus L.) et ses sels
13. Adonis vernalis L. et ses préparations
14. Epinéphrine (*)
15. Alcaloïdes des Rauwolfia serpentina et leurs sels
16. Alcools acétyléniques, leurs esters, leurs éthers-oxydes et leurs sels
17. Isoprénaline (*)
18. Allyle, isothiocyanate d'
19. Alloclamide (*) et ses sels
20. Nalorphine (*), ses sels et ses éthers-oxydes
21. Amines sympathicomimétiques à action sur le système nerveux central : toute substance énumérée dans la première liste de médicaments dont la délivrance est soumise à prescription médicale reprise dans la résolution A.P. (69) 2 du Conseil de l'Europe
22. Aminobenzène (aniline), ses sels et ses dérivés halogénés et sulfonés
23. Bétoxycaïne (*) et ses sels
24. Zoxazolamine (*)
25. Procaïnamide (*), ses sels et ses dérivés
26. Aminobiphényle, di- (benzidine)
27. Tuaminoheptane (*), ses isomères et ses sels
28. Octodrine (*) et ses sels
29. Amino-2 bis- (méthoxy-4 phényl) 1-2 éthanol et ses sels
30. Amino-2 méthyl-4 hexane et ses sels (*) Sont pourvues d'un astérisque, dans la présente directive, les dénominations conformes au «computer printout 1975, International Nonproprietary Names (INN) for pharmaceutical products, Lists 1-33 of proposed INN» publié par l'Organisation mondiale de la santé, Genève, août 1975.
31. Acide amino-4 salicylique et ses sels
32. Aminotoluène et ses isomères, leurs sels, leurs dérivés halogénés et sulfonés
33. Aminoxylènes, leurs isomères, leurs sels et leurs dérivés halogénés et sulfonés

34. 9-(3-Méthyl-2-butényloxy)-7H-furo [3,2-g] [1] benzopyrane-7-one (amidine)
35. Ammi majus L. et ses préparations
36. Amylène chloré (dichloro-2,3 méthyl-2 butane)
37. Androgène (substances à effet)
38. Anthracène (huile d')
39. Antibiotiques à l'exception de ceux repris nommément à l'annexe IV
40 Antimoine et ses composés
41. Apocynum cannabinum L. et ses préparations
42. 5,6,6a,7-Tétrahydro-6-méthyle-4 H-dibenzo [de, g] quinoline-10,11-diol. (apomorphine) et ses sels
43. Arsenic et ses composés
44. Atropa belladonna L. et ses préparations
45. Atropine, ses sels et ses dérivés
46. Baryum (sels de), à l'exception du sulfate de baryum, des laques à base de sulfate de baryum et des pigments préparés à partir des colorants figurant dans la liste des annexes III (2e partie) et IV (2e et 3e parties) portant le symbole Ba
47. Benzène
48. Benzimidazolone
49. Benzazépine et benzadiazépine, leurs sels et dérivés
50. Benzoate de diméthylamino- méthyl-2-butanol-2 et ses sels (amylocaïne)
51. Benzoyl-triméthyl-oxypipéridine (benzamine) et ses sels
52. Isocarboxazide (*)
53. Bendrofluméthiazide (*) et ses dérivés
54. Glucinium et ses composés
55. Brome métalloïde
56. Tosilate de brétylium (*)
57. Carbromal (*)
58. Bromisoval (*)
59. Bromphéniramine (*) et ses sels
60. Bromure de benzilonium (*)
61. Bromure de tétraéthylammonium (*)
62. Brucine
63. Tétracaïne (*) et ses sels
64. Mofébutazone (*)
65. Tolbutamide (*)
66. Carbutamide (*)
67. Phénylbutazone (*)
68. Cadmium et ses combinaisons
69. Cantharis vesicatoria
70. Cantharidine
71. Phenprobamate (*)
72. Carbazol (dérivés nitrés du)
73. Carbone (sulfure de)
74. Catalase
75. Céphéline et ses sels
76. Chenopodium ambrosioïdes L. (essence)
77. Chloral hydraté
78. Chlore élémentaire
79. Chlorpropamide (*)
80. Diphénoxylate (*)
81. Chlorhydrate-citrate de 2-4-diamino-azobenzène (chrysoïdine, chlorhydrate et/ou citrate)

82. Chlorozaxone (*)
83. Chlorodiméthylamino-méthyl pyrimidine (crimidine)
84. Chlorprothixène (*) et ses sels
85. Clofénamide (*)
86. Bis-(chloroéthyl) méthylamine-N oxyde et ses sels (mustine N-oxyde)
87. Chlorméthine (*) et ses sels
88. Cyclophosphamide (*) et ses sels
89. Mannomustine (*) et ses sels
90. Butanilicaïne (*) et ses sels
91. Chlormézanone (*)
92. Triparanol (*)
93. [(Chloro-4 phényl)-2 phényl-2) acétyl-2 dioxo-1,3 indane] (chlorophacinone)
94. Chlorophénoxamine (*)
95. Phénaglycodol (*)
96. Chlorure d'éthyle
97. Sels de chrome, acide chromique et ses sels
98. Claviceps purpurea Tul., ses alcaloïdes et ses préparations
99. Conium maculatum L. (fruit, poudre et préparations)
100. Glycyclamide (*)
101. Cobalt (benzènesulfonate de)
102. Colchicine, ses sels et ses dérivés
103. Colchicoside et ses dérivés
104. Colchicum autumnale L. et ses préparations
105. Convallatoxine
106. Anamirta Cocculus L. (fruits)
107. Croton Tiglium L. (huile)
108. N-(crotonoylamino-4 benzènesulfonyl) N'-butylurée
109. Curare et curarines
110. Curarisants de synthèse
111. Cyanhydrique (acide) et ses sels
112. Cyclohexyl-1 diéthylamino-3 (diéthylaminométhyl-2 phényl)-1 propane et ses sels
113. Cycloménol (*) et ses sels
114. Sodium hexacyclonate (*)
115. Hexapropymate (*)
116. Dextropropoxyphène (*)
117. 0,0'-diacétyl N-allyl desméthylmorphine
118. Pipazétate (*) et ses sels
119. >PIC FILE= "T9001001">
120. Bis-(triméthylammonio)-1,5 pentane (sels de, dont bromure de pentaméthonium (*))
121. Bromure d'azaméthonium (*)
122. Cyclarbamate (*)
123. Chlofénotane (*)
124. Bis-(triéthylammonio)-1,6 hexane (sels de, dont bromure d'hexaméthonium (*))
125. Dichloroéthane (chlorures d'éthylène)
126. Dichloroéthylène (chlorures d'acétylène)
127. Lysergide (*) et ses sels
128. Diéthylaminoéthyl (phényl-4' hydroxy-3' benzoate)-2 et ses sels
129. Cinchocaïne (*) et ses sels
130. Diéthylamino-3 propyl cinnamate
131. Diéthylnitro-4 phényl thiophosphate
132. N, N'-bis (2-diéthylaminoéthyl) oxamido bis (2-chlorobenzyle) [sels de, dont chlorure d'ambénonium (*)]
133. Méthyprylone (*) et ses sels
134. Digitaline et tous les hétérosides de la digitale
135. (Dihydroxy-2,6 méthyl-4 aza-4 hexyl)-7 théophylline (xanthinol)

RECOMMENDATION FOR SECOND READING ***II




195k

231k

24 May 2002




PE 232.072

A5-0180/2002

on the Council common position for adopting a European Parliament and Council directive amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
(15073/1/01 – C5‑0072/2002 – 2000/0077(COD))





Committee on the Environment, Public Health and Consumer Policy

Rapporteur: Dagmar Roth-Behrendt









PROCEDURAL PAGE



DRAFT LEGISLATIVE RESOLUTION



EXPLANATORY STATEMENT




PROCEDURAL PAGE








At the sitting of 3 April 2001 Parliament adopted its position at first reading on the proposal for a European Parliament and Council directive amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (COM(2000) 189 - 2000/0077 (COD)).
At the sitting of 28 February 2002 the President of Parliament announced that the common position had been received and referred to the Committee on the Environment, Public Health and Consumer Policy (15073/1/01 - C5-0072/2002).
The committee had appointed Dagmar Roth-Behrendt rapporteur at its meeting of 19 June 2000.
It considered the common position and draft recommendation for second reading at its meetings of 23 April 2002 and 23 May 2002.
At the last meeting it adopted the draft legislative resolution unopposed with 2 abstentions.
The following were present for the vote: Caroline F. Jackson , chairman; and Mauro Nobilia, Alexander de Roo, Anneli Hulthén, vice-chairmen; Dagmar Roth-Behrendt , rapporteur; María del Pilar Ayuso González, Hans Blokland, David Robert Bowe, John Bowis, Hiltrud Breyer, Hans Udo Bullmann (for Rosemarie Müller, pursuant to Rule 153(2), Philip Bushill-Matthews (for Per-Arne Arvidsson), Dorette Corbey, Rosa M. Díez González (for Béatrice Patrie, pursuant to Rule 153(2), Avril Doyle, Jillian Evans (for Marie Anne Isler Béguin), Francesco Fiori (for Raffaele Costa), Marialiese Flemming, Karl-Heinz Florenz, Laura González Álvarez, Robert Goodwill, Jutta D. Haug (for Anne Ferreira), Christa Klaß, Wilfried Kuckelkorn (for Catherine Stihler , pursuant to Rule 153(2), Bernd Lange, Peter Liese, Giorgio Lisi (for Martin Callanan), Torben Lund, Jorge Moreira da Silva, Eluned Morgan (for Minerva Melpomeni Malliori), Emilia Franziska Müller, Riitta Myller, Giuseppe Nisticò, Neil Parish (for Cristina García-Orcoyen Tormo), Marit Paulsen, Frédérique Ries, Guido Sacconi, Giacomo Santini (for Cristina Gutiérrez Cortines), Karin Scheele, Inger Schörling, Jonas Sjöstedt, María Sornosa Martínez, Dirk Sterckx (for Chris Davies), Robert William Sturdy (for Eija-Riitta Anneli Korhola), Astrid Thors, Antonios Trakatellis, Kathleen Van Brempt.
The recommendation for second reading was tabled on 24 May 2002.
The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session.

DRAFT LEGISLATIVE RESOLUTION










European Parliament legislative resolution on the Council common position for adopting a European Parliament and Council directive amending Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (15073/1/01 – C5‑0072/2002 – 2000/0077(COD))(Codecision procedure: second reading)
The European Parliament,
– having regard to the Council common position 15073/1/01 – C5‑0072/2002),
– having regard to its position at first reading(1) on the Commission proposal to Parliament and the Council (COM(2000) 189(2)),
– having regard to Article 251(2) of the EC Treaty,
– having regard to Rule 80 of its Rules of Procedure,
– having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Policy (A5‑0180/2002),
1. Amends the common position as follows;
2. Instructs its President to forward its position to the Council and Commission.








Council common position

Amendments by Parliament

Amendment 1
RECITAL 2 a (new)



(2a) In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes1 and with Council Directive 93/35/EEC of 14 June 19932 amending for the sixth time Directive 76/768/EEC, it is essential that the aim of abolishing animal experiments for cosmetics be pursued and that the prohibition of such experiments becomes effective on the territory of the Member States. In order to ensure that this prohibition is fully implemented, it may be necessary for the Commission to bring forward further proposals to amend Directive 86/609/EEC.
1 OJ L 358, 18.12.1986, p. 1.
2 OJ L 151, 23.6.1993, p. 32.


Reinstatement of am. 1 of first reading. See justification to am. 15.

Amendment 2
RECITAL 3

(3) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes has established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory. In order to facilitate the implementation of this provision in the cosmetic sector, specific provisions have been introduced by Directive 93/35/EEC amending for the sixth time Directive 76/768/EEC. However, these provisions concern only alternative methods which do not entail the use of animals and do not take account of alternative methods developed in order to reduce the number of animals used for experiments or to reduce their suffering. Therefore, in order to afford optimal protection to animals used for experimental purposes, the provisions of Directive 76/768/EEC should be amended in order to provide for the systematic use of all alternative methods, as foreseen by Article 7(2) and (3) of Directive 86/609/EEC, when these methods offer consumers a level of protection equivalent to that of the conventional methods which they are intended to replace.


(3) Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes has established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory. In order to facilitate the development and use of alternative methods which do not use live animals in the cosmetic sector, specific provisions have been introduced by Directive 93/35/EEC amending for the sixth time Directive 76/768/EEC. However, these provisions concern only alternative methods which do not use animals and do not take account of alternative methods developed in order to reduce the number of animals used for experiments or to reduce their suffering. Therefore, in order to afford optimal protection to animals used for cosmetics testing until implementation of the prohibition of animal tests for cosmetics and the marketing of animal-tested cosmetics in the Community, these provisions should be amended in order to provide for the systematic use of alternative methods which reduce the number of animals used or reduce the suffering caused, in those cases where full replacement alternatives are not yet available, as foreseen by Article 7(2) and (3) of Directive 86/609/EEC, when these methods offer consumers a level of protection equivalent to that of the conventional methods which they are intended to replace.


Until the full marketing ban on animal-tested cosmetics comes into force, this provision should be amended to include the use of reduction and refinement alternatives specifically in addition to full replacement alternatives and where these are not yet available.

Amendment 3
RECITAL 4

(4) Currently, only alternative methods which are scientifically validated by the European Centre for the Validation of Alternative Methods (ECVAM) or the Organisation for Economic Cooperation and Development (OECD) and applicable to the whole chemical sector are systematically adopted at the Community level. However, the safety of cosmetic products can be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, when such methods can guarantee an equivalent level of protection to consumers. For this purpose, the Commission should ensure that conventional testing methods are replaced as a priority by validated alternative methods which do not entail the use of animals or, failing that, by methods limiting significantly the number of animals used or by methods reducing significantly animal suffering.


(4) Currently, only alternative methods which are scientifically validated by the European Centre for the Validation of Alternative Methods (ECVAM) or the Organisation for Economic Cooperation and Development (OECD) and applicable to the whole chemical sector are systematically adopted at the Community level. However, the safety of cosmetic products and ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, when such methods offer an equivalent level of protection to consumers.


See justification to am. 15. The use and adoption in the Community of alternative methods specifically used for the safety assessment of cosmetic ingredients is supported.
In accordance with Directive 86/609/EEC, Member States should already be ensuring the use of non-animal alternative test methods, as well as reducement and refinement alternatives where these are available so there is no need to include this requirement here.

Amendment 4
RECITAL 5 a (new)



(5a) It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM). After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission will have immediately to publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline must be foreseen for the introduction of a definitive prohibition.


Reinstatement of Am. 3 of first reading. See justification to Am. 15.


Amendment 5
RECITAL 6

(6) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue its efforts and take the measures necessary for the promotion of research and the development of new methods, in particular within its Sixth Framework Programme as set out in Decision No 2002/...../EC of the European Parliament and of the Council.


(6) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Sixth Framework Programme as set out in Decision No 2002/...../EC of the European Parliament and of the Council.


The Community should not only continue but substantially increase its support for the development of alternative methods, in particular tests that do not use live animals.

Amendment 6
RECITAL 6 a (new)



(6a) If necessary, in order not to prevent the introduction of new products which offer significant improvements in health protection in terms of preventing illness, disease or serious health disorders, the Commission should bring forward a proposal in accordance with the Article 251 procedure. Such a proposal should not compromise the objectives of this Directive.


Reinstatement of am. 36 of first reading. This is to permit the marketing of new products defined as cosmetics but which might also be considered as having pharmaceutical properties beneficial to human health.


Amendment 7
RECITAL 7 a (new)



(7a) Public opinion demands that animal testing for cosmetics should be forbidden. In order to promote rapid development of alternatives and to ensure animal testing is not relocated to third countries, a Community prohibition on animal testing needs to be combined with mandatory labelling of products and ingredients tested on animals and measures which ensure that cosmetic products and ingredients tested on animals are not put on the Community market after a specified date. If satisfactory non-animal alternatives are not fully available by that date, it will be possible to apply such measures without compromising consumer safety while still allowing a considerable amount of product innovation.


Reinstatement of am. 37 of first reading. See justification to am. 13 and 15.


Amendment 8
RECITAL 8

( It should be possible to provide consumers with information relating to tests performed on cosmetic products. However, in order to ensure the transparency of the information made available to consumers in this regard and to guarantee the free movement of cosmetic products within the Community, it is important to specify the conditions under which it is possible to make claims for such products, or in the context of their marketing, that no animal testing has been carried out for their development or manufacture. For this purpose, it is necessary that, after consultation of all interested parties, the Commission prepare guidelines in order to provide clear guidance for economic operators on the use of such claims within the Community.


( It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, should develop guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission must also take into account the views of the many small and medium-sized enterprises which make up the majority of the 'non-animal testing' producers, relevant non-governmental organisations, and the need of consumers to be able to make practical distinctions between products on the basis of animal testing criteria.


Reinstatement of am. 7 of first reading. See justification to am. 22.

Amendment 9
RECITAL 8 a (new)



(8a) Whereas fragrances should not be used where they do not fulfil an essential purpose, in particular in products intended for children or products for external intimate hygiene.


Reinstatement of am. 43 of first reading.
A number of fragrances have been found to cause allergies. More such fragrances may lead to allergic reactions in the future. In order to avoid fragrance allergies, perfume substances should be prohibited in products where fragrances do not fulfil an essential purpose, where their addition is unnecessary. The use of fragrances should therefore be prohibited in products intended for children, e.g. in baby creams and shampoo, or in products of external intimate hygiene, e.g. in sanitary towels, toilet paper and cotton roundels.


Amendment 10
RECITAL 8 b (new)



(8b) The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers stated in its opinion of 25 September 2001 that substances classified according to Council Directive 67/548/EEC as carcinogens category 1 or 2 (except substances only carcinogenic by inhalation), mutagens category 1 and 2, or toxic to reproduction category 1 or 2 and substances with similar potentials, must not be intentionally added to cosmetic products, and that substances classified according to Council Directive 67/548/EEC as carcinogens category 3, mutagens category 3, or toxic to reproduction category 3 and substances with similar potential must not be intentionally added to cosmetic products unless it can be demonstrated that their levels do not pose a threat to the health of the consumer.


New amendment pursuant to Rule 80(2)(d) of Parliament’s Rules of Procedure. The most recent opinion of the Scientific Committee adopted after Parliament's first reading is an important new fact and should therefore be referred to.

Amendment 11
RECITAL 9

(9) Given the special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1 and 2, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, may entail for human health, their use in cosmetic products should be avoided, unless the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers considers such use as safe. The evaluation of these substances for use in cosmetic products should not involve, as far as possible, the use of animals.


(9) Given the special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction, category 1 and 2, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, may entail for human health, their use in cosmetic products should be prohibited. Given the special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction, category 3, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, may entail for human health, their use in cosmetic products should be prohibited, unless the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers considers such use as safe. The evaluation of these substances for use in cosmetic products should not involve the use of animals.


New amendment pursuant to Rule 80(2)(d) of Parliament’s Rules of Procedure. The amendment is based on the most recent opinion of the Scientific Committee adopted after Parliament's first reading.


Amendment 12
RECITAL 11 a (new)



(11a) Whereas a number of substances has been identified by the Scientific Committee on Cosmetic Products and Non-Food Products as likely to cause allergenic reactions and it will be necessary to restrict the use and/or impose certain conditions concerning these substances.


Reinstatement of am. 12 of first reading. See justification for am. 27.

Amendment 13
ARTICLE 1, PARAGRAPH 1
Article 4, paragraph 1, point (i) (Directive 76/768/EEC)

1) Article 4 (1) (i) shall be deleted;


Article 4 (1) (i) shall be replaced with the following:
(i) ingredients or combinations of ingredients tested on animals in order to meet the requirements of this Directive, where satisfactory methods to replace animal testing exist or, where these are not yet available, methods which reduce the number of animals used, or reduce the suffering caused, in particular methods which are scientifically validated as offering an equivalent level of protection for the consumer, and in any case not later than 5 years after the adoption of Directive 2002/.../EC amending for the seventh time Directive 76/768/EEC;




Animal testing conducted after this date shall not preclude the marketing of cosmetic products or ingredients already in use within the Community if such testing was not conducted by or on behalf of the manufacturer, his agents or suppliers.





When implementing this provision, the Commission and the Member States shall take account of the need to ensure that producers in third countries are afforded notice and treatment equivalent to those in the Community and in particular to avoid any discriminatory or unfair treatment.





Testing authorised in accordance with the procedure laid down in the second subparagraph of Article 4a (1a) shall be exempted from this provision.



Reinstatement of am. 14 of first reading, with the addition of reduction and refinement alternatives where fully replacement alternatives are not yet available.
Products which contain ingredients or combinations of ingredients tested on animals despite the existence of alternatives are already prohibited under Article 4 (1)(i) of Directive 93/35/EEC. The fact that the Commission and Member States have failed to implement this provision does not justify further extending the time limit. In order to encourage the most rapid development of non-animal alternative tests, it is necessary to set a date after which all new cosmetic products and ingredients marketed within the Community should not be tested on animals. If by that date alternatives are not sufficiently well developed, existing ingredients can be relied upon without compromising consumer safety.
Companies will be able to continue to market cosmetic products and use cosmetic ingredients available in the Community prior to the date of full implementation of the marketing ban. This would not apply however if further animal testing is then conducted on such products or ingredients by a manufacturer or on its behalf, including tests conducted by its suppliers or agents.
To help ensure WTO compliance, when implementing the existing and proposed marketing restrictions, the Commission must also ensure that producers in third countries are not treated less favourably than producers in the Community, e.g. by being given less notice or time to comply with the proposed marketing restrictions.

Amendment 14
ARTICLE 1, PARAGRAPH 1
Article 4, paragraph 1, points (ia) and (ib) (new) (Directive 76/768/EEC)



(ia) substances listed in Directive 67/548/EEC which are categorised as carcinogenic, mutagenic or toxic to reproduction category 1 or 2,




(ib) substances listed in Directive 67/548/EEC which are categorised as carcinogenic, mutagenic or toxic to reproduction category 3, unless they have been evaluated by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers and found acceptable for use in cosmetics.


New amendment pursuant to Rule 80(2)(d) of Parliament’s Rules of Procedure. The amendment is based on the most recent opinion of the Scientific Committee adopted after Parliament's first reading.

Amendment 15
ARTICLE 1, PARAGRAPH 2
Article 4a, paragraph 1, 2 (Directive 76/768/EEC)

2) the following Articles shall be inserted:
"Article 4a
1. Without prejudice to the general obligations deriving from Article 2, Member States shall prohibit:


2) the following Articles shall be inserted:
"Article 4a
1. Member States shall take all necessary measures to prohibit the performance on their territory of animal tests:


(a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this Directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated, accepted and published by the Organisation for Economic Cooperation and Development (OECD) and adopted at Community level;
(b) the marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated, accepted and published by the Organisation for Economic Cooperation and Development (OECD) and adopted at Community level;
(c) the performance on their territory of animal testing of finished cosmetic products in order to meet the requirements of this Directive;
(d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances or in Annex IX to this Directive.
2. No later than ..., the Commission shall, in accordance with the regulatory procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, establish the contents of Annex IX referred to in paragraph (1)(d). The alternative methods included in Annex IX shall offer consumers a level of protection equivalent to the animal tests they are intended to replace.
When proceeding with the technical adaptation of the said Annex IX, in accordance with Article 8(2), the Commission shall ensure that only alternative methods which do not involve the use of animals are employed, when such methods exist and offer an equivalent level of protection to consumers, and, failing that, the use of reduction methods limiting significantly the number of animals used or the use of refinement methods reducing significantly animal suffering.


(a) for tests performed on finished cosmetic products;
(b) for tests performed on ingredients or combinations of ingredients, as soon as an alternative method has been published by the Commission, after endorsement of its scientific validity by the European Centre for the Validation of Alternative Methods (ECVAM) and the ECVAM Scientific Advisory Committee, following consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, and in any case from 31 December 2004;


Reinstatement of the first part of am. 15 of first reading.
In accordance with Directive 86/609/EEC, Member States should already be ensuring that animal tests for finished products and for ingredients where alternative test methods are available, are not performed in their territory, so there is no need to include this requirement here. With regard to ingredients, it is important to set a date after which animal testing for cosmetics will no longer be conducted within the EU. By 31 December 2004 more than eleven years will have elapsed since the adoption of the sixth amendment and seven years since the original measure was due to come into force. Adopting a final date will intensify efforts to develop alternatives.

Amendment 16
ARTICLE 1, PARAGRAPH 2
Article 4a, paragraph 1 a (new) (Directive 76/768/EEC)



1 a. In exceptional circumstances where serious concerns arise with regard to the safety of an existing cosmetic ingredient, but which do not necessitate a precautionary immediate withdrawal from use, a manufacturer or competent authority may apply for a derogation to paragraph 1(b). An application shall be made to the Commission, which shall consult the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers and the European Parliament.
The decision shall be taken in accordance with the procedure provided for in Article 10. A derogation shall only be granted if:
(a) the ingredient is in wide use and cannot be substituted by another ingredient able to perform a similar function;
(b) the specific human health problem is explained and the need to conduct animal tests is justified, supported by a detailed research protocol proposed as the basis for the evaluation;
(c) the results of the research are made publicly available and independently assessed.
Ingredients tested in accordance with this procedure and found to be safe shall be listed in a separate annex to the Directive, which shall include a reference to the location of the test data.
Ingredients found to be unsafe or only safe to be used under specific conditions shall be listed in a separate annex to the Directive, which shall include a reference to the location of the test data and any specific conditions of use which shall apply.


Reinstatement of the second part of am. 15 of first reading.
If new safety concerns may arise about an existing ingredient which is in wide use and cannot easily be replaced by other ingredients, it may be legitimate to allow additional animal testing. The need for such testing must be scientifically justified and proposed as part of a detailed protocol which should include the number and types of animal tests to be conducted. Due to the sensitivity of this issue, and to ensure that the animal test ban is not undermined, it is necessary to ensure that such derogations are considered in an open manner, independently assessed and that the decisions and data made publicly available. The publication of the research results can also help to prevent duplication of such testing in third countries.

Amendment 17
ARTICLE 1, PARAGRAPH 2
Article 4a, paragraph 3 (Directive 76/768/EEC)

3. For the purpose of this Article:
(a) "finished cosmetic product" means the cosmetic product in its final formulation, as placed on the market and made available to the final consumer.


3. For the purposes of this Article:
(a) "finished cosmetic product" means the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype.


(b) "alternative method" means a method which does not entail the use of animals or, failing that, a method which reduces significantly the number of animals used, or a method which reduces significantly animal suffering;




(c) "animal" means any live non-human vertebrate, including free-living larval forms and/or reproducing larval forms, but excluding foetal or embryonic forms.




Reinstatement of Am. 16 of first reading. When drafting the original text of Article 4(1)(i), Parliament devised the term ’ingredients or combination of ingredients’ to cover all permutations ranging from single ingredients to the final product formulation. In order to avoid any abuse of the term ’Finished Product test’ it is necessary to ensure that the definition also includes any prototype or variation of the final product ingredients that may have been animal tested.
The Council definition of alternative tests also includes test that use fewer animals or cause less suffering in addition to non-animal replacement alternative which is to be welcomed in general. However, public opinion favours full replacement of animal testing.

Amendment 18
ARTICLE 1, PARAGRAPH 2
Article 4b (Directive 76/768/EEC)

Article 4b
The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1 or 2, under Annex I to Directive 67/548/EEC shall, without delay, be subject to a risk evaluation by the Commission. Measures which are deemed necessary, following this evaluation, shall be adopted in accordance with the regulatory procedure referred to in Article 10(2), after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers


Delete


See justification of am. 11 and 14; As a matter of precaution, all such substances should not be included in cosmetics unless it can be demonstrated that is safe for them to be used. Therefore, the Council proposal that such chemicals should be subject of a risk evalation before using in cosmetic products is not acceptable.


Amendment 19
ARTICLE 1, PARAGRAPH 2 (new)
Article 5a(2), second indent (new) (Directive 76/768/EEC)



In Article 5a(2) the following indent shall be added after the first indent:
"- the information required under Article 7a(1) (a), (b), (d), (f),(g) and (ga). The quantitative information pursuant to Article 7a(1)(a) that is to be included in the public inventory is limited to dangerous substances pursuant to Directive 67/548/EEC,"


Reinstatement of am. 21 of first reading.
It is unacceptable that crucial information such as the composition of the product, the specifications of the raw material, the safety assessment, data on undesirable effects on human health, proof of the effect claimed for the cosmetic product and information on animal testing is not publicly available. It is not sufficient that manufacturers merely have to keep that information readily accessible to the competent authorities of the Member State. These data should be included in the inventory that the Commission shall publish periodically. In order to safeguard confidentiality of recipes, the quantitative information is to be given only for dangerous substances.

Amendment 20
ARTICLE 1, PARAGRAPH 3
Article 6, paragraph 1, point c (Directive 76/768/EEC)

"(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 conditions, continues to fulfil its initial function and, in particular, remains in conformity with Article 2.


"(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 conditions, continues to fulfil its initial function and, in particular, remains in conformity with Article 2.


The date of minimum durability shall be indicated by the date itself followed by a symbol to be decided upon in accordance with the regulatory procedure referred to in Article 10(2). The date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order.


The date of minimum durability shall be indicated by the words: “best used before the end of …” followed by either:
- the date itself, or
- details of where it appears on the packaging. The date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order. Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months.


If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.";


If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.";




For cosmetic products with a minimum durability of more than 30 months, there shall be an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the period (in month, year)."


Reinstatement of part of am. 22 of the first reading. The purpose of this amendment is to provide the consumer with the information how long he may use the product without any harm to his health after opening the product.

Amendment 21
ARTICLE 1, PARAGRAPH 4
Article 6, paragraph 1, point (g), third part (Directive 76/768/EEC)

Perfume and aromatic compositions and their raw materials shall be referred to by the word "perfume" or "aroma". However, the presence of substances, the mention of which is required under the column "other limitations and requirements" in Annex III, shall be indicated in the list irrespective of their function in the product.


Deleted


Perfume and aromatic compositions shall be regarded as ingredients. Consumers have a right to full information on the contents of cosmetic products, including perfume and aromatic compositions .


Amendment 22
ARTICLE 1, PARAGRAPH 4 (new)
Article 6, paragraph 1, point (h) (new) (Directive 76/768/EEC)



In Article 6 the following paragraph (1)(h) shall be added:
Where a manufacturer has carried out or commissioned animal tests, after the date of implementation of the animal test ban established in Article 4a(1), on the finished product, its prototype or any of its ingredients, or has purchased the finished product or its ingredients from a third party who has carried out such tests, the product may only be marketed if the packaging and container bear the indication "Tested on animals" in indelible, easily legible lettering. The information contained in (g) may, however, be indicated on the packaging alone or as otherwise prescribed in (g). The information must be displayed on the most prominent and visible surface of the container and packaging and shall not be less than 20 percent of the total surface area.


Reinstatement of am. 39 of first reading. The Council proposal would not require companies which test their products on animals in the future to disclose that fact. This omission would leave a gap in the information given to consumers. Therefore, a mandatory labelling of animal tested cosmetics as an interim step until a full marketing ban is introduced.

Amendment 23
ARTICLE 1, PARAGRAPH 5
Article 6, paragraph 3, last sentence (Directive 76/768/EEC)

The last sentence of Article 6(3) shall be replaced by the following subparagraph:
"Guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 10(2) regarding the information which a manufacturer or person responsible for placing the product on the market may specify on the products or in any document, leaflet, label, tape or card accompanying or referring to them, indicating that no animal tests have been carried out for their development or manufacture;"


The last sentence of Article 6(3) shall be replaced by the following subparagraph:
"Furthermore, the manufacturer or the person responsible for placing the product on the Community market may only take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, of the fact that no animal tests have been carried out provided the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished product, or its prototype, or any of the ingredients contained in it, nor knowingly used any ingredients that have been tested on animals for the purpose of developing new cosmetic products by others. The Commission, in consultation with the Member States and the European Parliament, shall for this purpose publish guidelines on the implementation of this principle;"


Reinstatement of am. 47 of first reading.
If additional clarity is required on the question of labelling, this amendment seeks to ensure that legitimate claims can be made by companies based on those aspects over which they can reasonably be expected to exercise control and which are directly relevant to the development of their cosmetic products. It is unreasonable to expect companies to know about or take responsibility for all animal testing conducted or commissioned by others, including for non-cosmetics purposes.

Amendment 24
ARTICLE 1, PARAGRAPH 6
Article 7a, paragraph 1, point (d), second part (Directive 76/768/EEC)

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 available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority/authorities concerned;


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 available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority/authorities concerned, in this case the information should be easily accessible within the European Union;


self-explanatory


Amendment 25
ARTICLE 1, PARAGRAPH 6 (new)
Article 7a, paragraph 1, point (ga) (new) (Directive 76/768/EEC)



In Article 7a the following paragraph (1)(ga) shall be added:
"(ga) Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.


Reinstatement of am. 27 of first reading.
In order to be able to enforce the animal testing restriction, and where appropriate, to determine whether animal testing was performed to meet other legislative requirements in third countries, it is necessary for manufacturers and their agents to include all relevant information in their product dossier.

Amendment 26
ARTICLE 1, PARAGRAPH 6 (new)
Article 7a, paragraph 1a (new) (Directive 76/768/EEC)



In Article 7a the following paragraph 1a is added:
"1a. The information required under paragraph (1)(a), (b), (d), (f), (g) and (ga) shall be communicated both to the competent authorities of the Member State and to the Commission to allow its inclusion in the inventory to be drawn up by the Commission pursuant to Article 5a. The quantitative information pursuant to paragraph 1(a) that is to be communicated shall be limited to the dangerous substances pursuant to Directive 67/548/EEC."


Reinstatement of am. 28 of first reading.
It is unacceptable that crucial information such as composition of the product, the specifications of the raw material, the safety assessment, data on undesirable effects on human health and proof of the effect claimed for the cosmetic product are not publicly available. It is not sufficient that manufacturers merely have to keep that information readily accessible to the competent authorities of the Member State. These data should be included in the inventory that the Commission shall publish periodically. In order to safeguard confidentiality of recipes, the quantitative information is to be given only for dangerous substances.

Amendment 27
ARTICLE 1, PARAGRAPH 8
Article 9 (Directive 76/768/EEC)

Articles 9 and 10 shall be replaced by the following:
"Article 9
Every three years the Commission shall present a report to the European Parliament and the Council on:
(a) progress made in the development, validation and legal acceptance of alternative methods, as defined in Article 4a(3)(b). The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals in order to comply with the requirements of this Directive. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes;
(b) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and to facilitate the recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;
(c) the manner in which the specific needs of small and medium-sized enterprises have been taken into account, in particular for the implementation of the provisions of Article 4a.


Article 9 and 10 shall be replaced by the following:
"Article 9
Every year the Commission shall present a report to the European Parliament and the Council on:
(a) progress made in the development, validation and legal acceptance of alternative methods. The 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 Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;
(b) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;
(c) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.


In order to enable effective monitoring of all progress related to alternative test methods, this information should be published on a yearly basis. Particular attention should be given to non-animal alternative test methods.