\n\t\t\t\t\t\t\t \t\t\tOBJECTIVE: this third annual Commission report (1996) on the development, validation and legal\nacceptance of alternative methods to animal experiments in the field of cosmetics reviews the\nsituation on the eve of the date by which the Commission has to present draft measures postponing\nthe date for the ban on animal testing if alternative methods have not been scientifically validated\n(1 January 1998).\nSUBSTANCE: the report comprises two parts. The first describes the objectives and anticipated\nconstraints concerning legal acceptance on the eve of the date (1 January 1998) from which the ban\non cosmetic products containing ingredients or combinations of ingredients tested on animals is due\nto be introduced. The second part is more scientific and describes the initiatives taken with a view\nto the development, validation and legal acceptance of alternative methods.\n(1) Objectives and constraints: two principal objectives are pursued:\n- the safety of cosmetic products with regard to human health: in this connection the basic\n'Cosmetics' Directive (93/35/EEC) requires manufacturers, as from 1 January 1995, to keep certain\ninformation on product safety readily accessible to the competent authorities. It also establishes a\nsystem of lists of prohibited products, products subject to certain limitations and authorized\nproducts.\nThese lists are regularly adapted to technical progress. The Commission believes that a blanket ban\non the use of new substances would not obviate the need for tests. Furthermore, putting a stop to\ninnovation in this area would spell ruin for many SMEs;\n- reduction/elimination of animal suffering: the Commission recognizes the fact that it is a question\nof ethical imperatives, even though tests of this type account for a mere 0.03% of all animal tests.\nHowever, it feels that the use of human volunteers cannot in itself replace animal tests across the\nboard.\nThe constraints which have to be taken into account concerning acceptance of alternative methods\nfall into two categories:\n- compatibility with the rules of international trade (especially WTO rules): any measure that leads\nto banning products from third countries because they have been tested on animals is likely to prove\nincompatible with these rules. The Commission is therefore proposing to review the basic\n'Cosmetics' Directive in order to resolve this problem;\n- the interests of SMEs must be safeguarded, particularly with regard to jobs created in this sector.\n(2) Existing and expected results: a distinction must be made between ingredients (and/or\ncombinations of ingredients) and finished cosmetic products:\n- ingredients/combinations of ingredients: the report notes that no alternative method offering an\nequivalent degree of protection are available as yet, nor are they expected to become available by\n1 January 1998. However, alternative methods should progressively become available in the\ndomains\npertaining to percutaneous absorption and local risks to the eye and skin: photoirritation, eye\nirritation and skin irritation (same conclusions as the 1995 report - see COS0505). By contrast, in\nthe case of tests relating to systemic effects, there is no hope of replacing animal testing in the\nforeseeable future, although the reduction in the number of animals used for tests should continue;\n- finished cosmetic products: after 1 January 1998 it will be possible to evaluate these products\nwithout animal testing as a result of available knowledge on the safety of their ingredients.\nHowever,\nthe report notes that there are grounds to fear toxic effects as a result of interaction between\ningredients or where skin penetration by ingredients is facilitated by the vehicle used. In such cases\nanimal testing is likely to remain necessary.\n(3) Conclusions: while research has made progress, no alternative test methods have yet been\nscientifically validated and accepted. The situation is unlikely to change before 1 January 1998. The\nCommission is therefore proposing:\n- postponement of the ban on products tested on animals until 30 June 2000,\n- presentation of draft measures before 1 January 2000, taking account of progress made by that\ndate, \n- promotion of research into and validation of alternative methods,\n- dissemination among SMEs of testing methods for finished products which do not involve the use\nof animals,\n- presentation of a proposal banning animal testing for finished cosmetic products as of\n1 January 1998 (to be adopted by the Codecision Procedure with the European Parliament; also\ncovers aspects relating to products from third countries).\n�
\n\t\t \t\t\t\t\t\t
\n"],"title":"COM(1997)0182","type":"Non-legislative basic document published","url":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=1997&nu_doc=182"}],"type":"Non-legislative basic document published"},{"body":"EP","committees":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Consumer Protection","date":"1997-07-02T00:00:00","rapporteur":[{"group":"PSE","mepref":"4f1adae3b819f207b3000097","name":"ROTH-BEHRENDT Dagmar"}],"responsible":true}],"date":"1997-07-18T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},{"body":"EP","committees":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Consumer Protection","date":"1997-07-02T00:00:00","rapporteur":[{"group":"PSE","mepref":"4f1adae3b819f207b3000097","name":"ROTH-BEHRENDT Dagmar"}],"responsible":true}],"date":"1997-09-24T00:00:00","docs":[{"title":"A4-0277/1997","type":"Committee report tabled for plenary, single reading","url":"http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A4-1997-277&language=EN"}],"text":["
\n\t\t\t\t\t\t\t \t\t\tThe EU should press for a change to world trade guidelines in order to accommodate environmental concerns and animal welfare, the Environment, Public Health and Consumer Protection Committee urged.\nThe committee adopted unanimously a motion for a resolution drafted by Mrs Dagmar ROTH-BEHRENDT (PES, D) on the Commission's recently published report for 1996 which deals with the development of alternatives to animal experiments in the field of cosmetics. \n\"With regard to GATT/WTO, the EU should formulate a definitive position without further delay and test GATT guidelines to the limit,\" the draft states. \"In parallel, it should press for a positive change to GATT guidelines in order to reconcile trade and valid environmental and animal welfare concerns.\"\nThe problem is that some countries insist that cosmetics be tested on animals before they can be sold. The EU is a major exporter of cosmetics. \nNevertheless, the draft resolution, adopted as part of a non-legislative report on the subject drafted by Mrs Roth-Behrendt, calls on the European Commission to bring forward a proposal to ban animal testing of cosmetic products and ingredients by 1 January 1998, as laid down in earlier EU legislation. Parliament has previously taken the view that the production of new cosmetics should not cause animals to suffer. \nThe draft resolution is a direct challenge to the Council of Ministers, which has accepted a Commission proposal to postpone the date of implementation of a ban until 1 June 2000 to allow further time for the development of alternatives. \nThe committee believes that not enough research is being done to find alternatives.\nAccordingly, there is a call for the Community's fifth research framework programme to be amended to research outside the Commission into alternatives. \n�
\n\t\t \t\t\t\t\t\t
\n"],"type":"Vote in committee, 1st reading/single reading"},{"body":"EP","date":"1997-10-22T00:00:00","docs":[{"text":["
\n\t\t\t\t\t\t\t \t\t\tThe European Parliament approved without debate the report by Mrs Dagmar Roth-Behrendt\n(PSE, D) on the Commission Communication on animal experiments in the field of cosmetics. In\nits resolution, Parliament deeply regrets the acceptance by the Council of the Commission proposal\nto postpone the date of implementation of the ban on the marketing of cosmetics containing\ningredients tested on animals until 1 June 2000. Furthermore, more than four years after adoption\nof Directive 93/35/EEC, the Commission is still not able to provide detailed statistics on animal\nexperiments. Little progress has been made in adopting alternative methods.\nQuestioning the effectiveness of the measures taken since 1993 to develop and validate alternative\nmethods, Parliament calls on the Commission to:\n- bring forward without delay a Parliament/Council proposal to ban animal testing of finished\ncosmetic products with effect from 1 January 1998; Parliament believes that this is the only way\nto\nforce the sector to develop and validate alternative methods;\n- at the very least, include in this proposal a full ban on animal testing of finished products and fix\nthe year 2000 as the deadline for implementation of the ban with regard to ingredients;\n- take positive and urgent measures to give new momentum to the development of alternative\nmethods (for example through the Community's framework R & D programme);\n- avoid further delays to both the implementation of the ban and the acceptance of alternative\nmethods resulting from efforts aimed at acquiring the widest possible international acceptance (such\nacceptance is not required by Directive 93/35/EEC). With regard to compliance with WTO rules,\nthe EU should adopt a position without delay and press for GATT guidelines reconciling trade,\nenvironmental and animal welfare concerns;\n- draw up a comprehensive strategy in order to speed up the development of alternative methods,\nwith appropriate division of responsibilities among the parties concerned and forcing the sector to \ndo more to achieve the objective; Parliament suggests in this connection, as in the case of previous\nresolutions, that companies and institutions undertaking animal tests be required to participate in\nthe\ndevelopment of alternative validation methods or to pay a levy/duty to fund such work.\n�
\n\t\t \t\t\t\t\t\t
\n"],"title":"T4-0495/1997","type":"Decision by Parliament, 1st reading/single reading"}],"type":"Decision by Parliament, 1st reading/single reading"},{"date":"1997-11-10T00:00:00","type":"Final act published in Official Journal"}],"path":["activities"],"type":"added"},{"data":[],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Consumer Protection","date":"1997-07-02T00:00:00","rapporteur":[{"group":"PSE","mepref":"4f1adae3b819f207b3000097","name":"ROTH-BEHRENDT Dagmar"}],"responsible":true}],"path":["committees"],"type":"added"},{"data":{},"path":["links"],"type":"added"},{"data":{"dossier_of_the_committee":"ENVI/4/08919","legal_basis":["Rules of Procedure of the European Parliament EP 132"],"reference":"1997/2093(COS)","stage_reached":"Procedure completed","subject":["3.40.12 Luxury products industry, cosmetics","4.20.02.06 Clinical practice and experiments"],"subtype":"Commission strategy paper","title":"Cosmetics: development, validation and legal acceptance of alternative methods to animal experiments. 1996 report","type":"COS - Procedure on a strategy paper (historic)"},"path":["procedure"],"type":"added"}],"2019-07-06T14:35:59":[{"data":["ENVI/4/08919",["ENVI/4/08919"]],"path":["procedure","dossier_of_the_committee"],"type":"changed"},{"data":[["3.40.12 Luxury products industry, cosmetics","4.20.02.06 Clinical practice and experiments"],{"3.40.12":"Luxury products industry, cosmetics","4.20.02.06":"Clinical practice and experiments"}],"path":["procedure","subject"],"type":"changed"},{"data":"Rules of Procedure EP 132","path":["procedure","legal_basis",0],"type":"added"},{"data":"Rules of Procedure of the European Parliament EP 132","path":["procedure","legal_basis",0],"type":"deleted"},{"data":[{"body":"EP","date":"1997-08-22T00:00:00","docs":[{"title":"PE223.450"}],"type":"Committee draft report"},{"body":"EP","date":"1997-09-24T00:00:00","docs":[{"title":"A4-0277/1997","url":"http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A4-1997-277&language=EN"},{"title":"OJ C 325 27.10.1997, p. 0003","url":"https://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:1997:325:SOM:EN:HTML"}],"type":"Committee report tabled for plenary, single reading"},{"body":"EP","date":"1997-10-22T00:00:00","docs":[{"title":"OJ C 339 10.11.1997, p. 0047-0061","url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:1997:339:TOC"},{"title":"T4-0495/1997"}],"summary":[],"type":"Text adopted by Parliament, single reading"}],"path":["docs"],"type":"added"},{"data":[],"path":["other"],"type":"deleted"},{"data":[{"body":"EC","date":"1997-05-05T00:00:00","docs":[{"title":"EUR-Lex","url":"https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=1997&nu_doc=182"},{"title":"COM(1997)0182"}],"summary":[],"type":"Non-legislative basic document published"},{"body":"EP","date":"1997-07-18T00:00:00","type":"Committee referral announced in Parliament, 1st reading/single reading"},{"body":"EP","date":"1997-09-24T00:00:00","summary":[],"type":"Vote in committee, 1st reading/single reading"},{"body":"EP","date":"1997-09-24T00:00:00","docs":[{"title":"A4-0277/1997","url":"http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A4-1997-277&language=EN"}],"type":"Committee report tabled for plenary, single reading"},{"body":"EP","date":"1997-10-22T00:00:00","docs":[{"title":"T4-0495/1997"}],"summary":[],"type":"Decision by Parliament, 1st reading/single reading"},{"body":"EP","date":"1997-10-22T00:00:00","type":"End of procedure in Parliament"},{"date":"1997-11-10T00:00:00","type":"Final act published in Official Journal"}],"path":["events"],"type":"added"},{"data":{},"path":["links"],"type":"deleted"},{"data":[{"body":"EC","commission":[],"date":"1997-05-05T00:00:00","docs":[{"celexid":"CELEX:51997DC0182:EN","text":["
\n\t\t\t\t\t\t\t \t\t\tOBJECTIVE: this third annual Commission report (1996) on the development, validation and legal\nacceptance of alternative methods to animal experiments in the field of cosmetics reviews the\nsituation on the eve of the date by which the Commission has to present draft measures postponing\nthe date for the ban on animal testing if alternative methods have not been scientifically validated\n(1 January 1998).\nSUBSTANCE: the report comprises two parts. The first describes the objectives and anticipated\nconstraints concerning legal acceptance on the eve of the date (1 January 1998) from which the ban\non cosmetic products containing ingredients or combinations of ingredients tested on animals is due\nto be introduced. The second part is more scientific and describes the initiatives taken with a view\nto the development, validation and legal acceptance of alternative methods.\n(1) Objectives and constraints: two principal objectives are pursued:\n- the safety of cosmetic products with regard to human health: in this connection the basic\n'Cosmetics' Directive (93/35/EEC) requires manufacturers, as from 1 January 1995, to keep certain\ninformation on product safety readily accessible to the competent authorities. It also establishes a\nsystem of lists of prohibited products, products subject to certain limitations and authorized\nproducts.\nThese lists are regularly adapted to technical progress. The Commission believes that a blanket ban\non the use of new substances would not obviate the need for tests. Furthermore, putting a stop to\ninnovation in this area would spell ruin for many SMEs;\n- reduction/elimination of animal suffering: the Commission recognizes the fact that it is a question\nof ethical imperatives, even though tests of this type account for a mere 0.03% of all animal tests.\nHowever, it feels that the use of human volunteers cannot in itself replace animal tests across the\nboard.\nThe constraints which have to be taken into account concerning acceptance of alternative methods\nfall into two categories:\n- compatibility with the rules of international trade (especially WTO rules): any measure that leads\nto banning products from third countries because they have been tested on animals is likely to prove\nincompatible with these rules. The Commission is therefore proposing to review the basic\n'Cosmetics' Directive in order to resolve this problem;\n- the interests of SMEs must be safeguarded, particularly with regard to jobs created in this sector.\n(2) Existing and expected results: a distinction must be made between ingredients (and/or\ncombinations of ingredients) and finished cosmetic products:\n- ingredients/combinations of ingredients: the report notes that no alternative method offering an\nequivalent degree of protection are available as yet, nor are they expected to become available by\n1 January 1998. However, alternative methods should progressively become available in the\ndomains\npertaining to percutaneous absorption and local risks to the eye and skin: photoirritation, eye\nirritation and skin irritation (same conclusions as the 1995 report - see COS0505). By contrast, in\nthe case of tests relating to systemic effects, there is no hope of replacing animal testing in the\nforeseeable future, although the reduction in the number of animals used for tests should continue;\n- finished cosmetic products: after 1 January 1998 it will be possible to evaluate these products\nwithout animal testing as a result of available knowledge on the safety of their ingredients.\nHowever,\nthe report notes that there are grounds to fear toxic effects as a result of interaction between\ningredients or where skin penetration by ingredients is facilitated by the vehicle used. In such cases\nanimal testing is likely to remain necessary.\n(3) Conclusions: while research has made progress, no alternative test methods have yet been\nscientifically validated and accepted. The situation is unlikely to change before 1 January 1998. The\nCommission is therefore proposing:\n- postponement of the ban on products tested on animals until 30 June 2000,\n- presentation of draft measures before 1 January 2000, taking account of progress made by that\ndate, \n- promotion of research into and validation of alternative methods,\n- dissemination among SMEs of testing methods for finished products which do not involve the use\nof animals,\n- presentation of a proposal banning animal testing for finished cosmetic products as of\n1 January 1998 (to be adopted by the Codecision Procedure with the European Parliament; also\ncovers aspects relating to products from third countries).\n�
\n\t\t \t\t\t\t\t\t
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\n\t\t\t\t\t\t\t \t\t\tThe EU should press for a change to world trade guidelines in order to accommodate environmental concerns and animal welfare, the Environment, Public Health and Consumer Protection Committee urged.\nThe committee adopted unanimously a motion for a resolution drafted by Mrs Dagmar ROTH-BEHRENDT (PES, D) on the Commission's recently published report for 1996 which deals with the development of alternatives to animal experiments in the field of cosmetics. \n\"With regard to GATT/WTO, the EU should formulate a definitive position without further delay and test GATT guidelines to the limit,\" the draft states. \"In parallel, it should press for a positive change to GATT guidelines in order to reconcile trade and valid environmental and animal welfare concerns.\"\nThe problem is that some countries insist that cosmetics be tested on animals before they can be sold. The EU is a major exporter of cosmetics. \nNevertheless, the draft resolution, adopted as part of a non-legislative report on the subject drafted by Mrs Roth-Behrendt, calls on the European Commission to bring forward a proposal to ban animal testing of cosmetic products and ingredients by 1 January 1998, as laid down in earlier EU legislation. Parliament has previously taken the view that the production of new cosmetics should not cause animals to suffer. \nThe draft resolution is a direct challenge to the Council of Ministers, which has accepted a Commission proposal to postpone the date of implementation of a ban until 1 June 2000 to allow further time for the development of alternatives. \nThe committee believes that not enough research is being done to find alternatives.\nAccordingly, there is a call for the Community's fifth research framework programme to be amended to research outside the Commission into alternatives. \n�
\n\t\t \t\t\t\t\t\t
\n"],"type":"Vote in committee, 1st reading/single reading"},{"body":"EP","date":"1997-10-22T00:00:00","docs":[{"text":["
\n\t\t\t\t\t\t\t \t\t\tThe European Parliament approved without debate the report by Mrs Dagmar Roth-Behrendt\n(PSE, D) on the Commission Communication on animal experiments in the field of cosmetics. In\nits resolution, Parliament deeply regrets the acceptance by the Council of the Commission proposal\nto postpone the date of implementation of the ban on the marketing of cosmetics containing\ningredients tested on animals until 1 June 2000. Furthermore, more than four years after adoption\nof Directive 93/35/EEC, the Commission is still not able to provide detailed statistics on animal\nexperiments. Little progress has been made in adopting alternative methods.\nQuestioning the effectiveness of the measures taken since 1993 to develop and validate alternative\nmethods, Parliament calls on the Commission to:\n- bring forward without delay a Parliament/Council proposal to ban animal testing of finished\ncosmetic products with effect from 1 January 1998; Parliament believes that this is the only way\nto\nforce the sector to develop and validate alternative methods;\n- at the very least, include in this proposal a full ban on animal testing of finished products and fix\nthe year 2000 as the deadline for implementation of the ban with regard to ingredients;\n- take positive and urgent measures to give new momentum to the development of alternative\nmethods (for example through the Community's framework R & D programme);\n- avoid further delays to both the implementation of the ban and the acceptance of alternative\nmethods resulting from efforts aimed at acquiring the widest possible international acceptance (such\nacceptance is not required by Directive 93/35/EEC). With regard to compliance with WTO rules,\nthe EU should adopt a position without delay and press for GATT guidelines reconciling trade,\nenvironmental and animal welfare concerns;\n- draw up a comprehensive strategy in order to speed up the development of alternative methods,\nwith appropriate division of responsibilities among the parties concerned and forcing the sector to \ndo more to achieve the objective; Parliament suggests in this connection, as in the case of previous\nresolutions, that companies and institutions undertaking animal tests be required to participate in\nthe\ndevelopment of alternative validation methods or to pay a levy/duty to fund such work.\n�
\n\t\t \t\t\t\t\t\t
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