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Directorate-General for Health and Food Safety
0. In memorian : Prof. Yannick De
Roeck-Holtzhauer
With sadness, the European Commission and the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers were informed of the passing away of Prof. Y. De Roeck, born Holtzhauer.
Mme De Roeck was awarded several distinctions such as "Chevalier dans l'Ordre des Palmes Academiques" in 1970 followed in 1991 by the order of merit "Officier dans l'Ordre des Palmes Academiques".
At European level, Mme De Roeck created a number of activities, especially on the sectors of marine programmes such as "Arc Atlantique" and international courses on ingredients of cosmetic products. She was a member of the SCCNFP since 1997.
In the name of the SCCNFP, a letter of condolences was sent to her husband, Prof. H. De Roeck, and her family.
The Chairman invited the meeting to stand up for a minute of silence.
1. Adoption of the Agenda (doc. n° SCCNFP/0192/99) (Annex 1)
The agenda was adopted subject to some minor corrections and subject to the insertion of the draft opinions on :
- hydrogen peroxide and hydrogen peroxide releasing substances used in oral care products
- ketoconazole.
2. Approval of the minutes of the 7th plenary meeting of 17 February 1999
doc. n° SCCNFP/0126/99
The minutes were adopted subject to the correction of the typographical errors.
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
In the absence of the Co-ordinator, Prof. Loprieno, the various rapporteurs were asked to present the documents approved by the Working Party and addressed to the plenary meeting for formal adoption.
Draft opinions were prepared on :
Basic criteria for the in vitro assessment of percutaneous absorption of cosmetic products, doc. n° SCCNFP/0167/99 rev. 3
Because of the great variety of in vitro percutaneous absorption studies presented to the SCCNFP in the framework of the safety assessment of cosmetic ingredients, the Committee felt there was a need to formulate minimal criteria for the acceptance of such studies.
The document describes the basic criteria for the in vitro assessment of the percutaneous absorption of a cosmetic ingredient. The principles and basic elements of such studies are addressed.
The meeting adopted the document.
The Chairman proposed to publish this document not only on the web site of the Scientific Committees but also in scientific periodicals to give it the largest possible distribution/publicity.
This was agreed.
Present development and validation of adequate alternative methodologies to the use of animals in safety testing of cosmetics, doc. n° SCCNFP/0177/99 rev. 1
Further to a request from the Commission, the SCCNFP assessed the possibility to replace animal test by alternative methods in the safety evaluation of cosmetic ingredients. The document, addressed to the Commission to answer questions of a scientific nature, represents the state-of-the-art in this domain and indicates as well those end-points for which alternative methods are not yet available.
In the margin of the discussion, the meeting expressed its full support to the letter sent by Chairman, Prof. Kemper, on 22.2.99 to Dr. H. Reichenbach, Director General of DG XXIV concerning animal tests. This letter is annexed to the document (Annex 2).
Guidelines on the use of human volunteers in compatibility testing of finished cosmetic products, doc. n° SCCNFP/0068/98, rev. 3
Although there is no legal requirement that finished cosmetic products have to be tested before marketing, confirmatory compatibility tests of a finished cosmetic product in humans may be needed ethically and consequently scientifically, provided that the toxicological profile of its ingredients is available.
The plenary meeting adopted these guidelines which take into consideration the ethical and practical aspects when human volunteers are involved in studies organised to assess skin and mucous membrane compatibility of finished cosmetic products.
Updating of the Notes of Guidance for testing of cosmetic ingredients for their safety evaluation, doc. n° SCCNFP/0119/99, rev. 3
Dr. Drion presented the document and highlighted the various changes with respect to the previous version.
Subject to some minor corrections, the document was adopted by the plenary meeting.
To put in perspective the importance of these Notes of Guidance, Dr. Bansil stated that these Notes not only give clear directions to industry of what is requested from them but also will be used by DG III as a basis for their work on international harmonisation of regulations in the domain of cosmetic products.
3.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that a series of draft opinions were prepared by the Working Party and now tabled for formal adoption. Prior to this exercise, he made some general statements, namely that (i) not all sensitisation studies were performed according to the present OECD Guidelines but that no new studies are requested provided that cosmetic products containing such a substance carry a label warning of a potential risk of sensitisation and (ii) that the substance name on the cover of the opinion should be the INCI name to bring the opinions in line with the Inventory.
Draft opinions were prepared on :
* A1 - 1,7-Naphthalenediol SCCNFP/0128/99
* A17 - 1-Naphthol SCCNFP/0130/99
* A22 - p-Methylaminophenol SCCNFP/0179/99
* A25 - Hydroxybenzomorpholine SCCNFP/0131/99
* A31 - 2-Methyl-5-hydroxyethylaminophenol SCCNFP/0132/99
* A39 - Phenylmethylpyrazolon SCCNFP/0134/99
* A43 - 1-Hydroxy-3-amino-2,4-dichloro-benzene SCCNFP/0135/99
* A79 - 1,3-Bis-(2,4-diaminophenoxy)propane SCCNFP/0136/99
* A101 - 2,6-Dimethoxy-3,5-pyridinediamine, HCl SCCNFP/0181/99
* A113 - 2,4-Diamino-5-methylphenethol, HCl SCCNFP/0138/99
* A116 - 2,4-Diamino-5-methylphenoxyethanol HCl SCCNFP/0139/99
* B72 - 2-Hydroxyethylpicramic acid SCCNFP/0182/99
* B73 - HC Blue n° 12 SCCNFP/0140/99
* B75 - Hydroxyethyl-2-nitro-p-toluidine SCCNFP/0183/99
* B77 - HC Blue n° 11 SCCNFP/0184/99
* B90 - Hydroxyethyl-2,6-dinitro-p-anisidine SCCNFP/0141/99
* B92 - 6-Nitro-2,5-pyridinediamine SCCNFP/0185/99
* B98 - HC violet n° 2 SCCNFP/0142/99
* B100 - 4-Hydroxypropylamino-3-nitrophenol SCCNFP/0186/99
These 19 opinions were adopted with a classification 1 ( may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in each case). However, cosmetic products containing these substances, except for A39, B72 and B98, should carry a label warning of a risk of sensitisation.
It was also suggested that for all future opinions on hair dyes, when there is a statement on sensitisation, a warning should be prominent on the package saying that hair dye chemicals can cause allergic skin reactions, which can be severe.
3.3 Inventory
Report of the Co-ordinator
Prof. Parra reported on the on-going work on the 1st update of the inventory. He mentioned that a complete draft is not yet available as a number of issues still need to be discussed within the Working Party and with COLIPA.
Amongst others, the following 'priority' items are on the agenda : guidelines for botanical ingredients and derivatives, major problems encountered while processing the new entries, nomenclature conventions for colorants and hair dyes.
It is intended to begin with bilateral consultations on this subject in the near future.
3.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White mentioned the work done since the previous plenary meeting, and in particular on the labelling of fragrance allergens.
In the context of this work, industry was invited and afforded the opportunity to contribute to the scientific review process concerning fragrance ingredient allergy. The perceived size of the problem as well as its definition were discussed. There was agreement on the importance of primary prevention as the crucial parameter in addressing fragrance ingredients allergy. It was also agreed that secondary prevention of allergic reactions was also very important and to a certain extend a common position was reached concerning secondary prevention : to provide the necessary information to the consumer. While the SCCNFP preferred the selective labelling of recognised fragrance ingredients, industry felt that the other systems as well as such ingredient listing, should be looked at, including bar or numerical code on the package or an ingredients data base accessible to dermatologists.
However, due to repercussions from various quarters on the draft opinion and although there was agreement in general, the Committee decided to re-style the document in such a way that it better corresponds to the questions asked in the mandate. The mandate will be inserted as well as a chapter on the background of the issue. The reformatted document on fragrance identification will form part of a continuing assessment of fragrance ingredient safety.
The plenary meeting thus adopted this situation and the underlying facts as an interim position on fragrance allergy.
Draft opinions were prepared and presented on :
P91 : 3-Iodo-2-propynyl-butyl-carbamate (IPBC), doc. n° SCCNFP/0193/99
An opinion on the use of IPBC as a preservative was adopted during the plenary meeting of 24.6.97. Because of concern with respect to potential biological effects on the endocrine system (high percutaneous absorption rate and Iodine content), a special investigation to estimate the possible influences on endocrine functions was requested and performed.
The rapporteur presented the draft revised opinion and mentioned that the study shows that the percutaneous absorption, recently investigated with modern methodology, is much less than initially stated and that consequently an absorption of Iodine in this range would not cause in general adverse effects up to a concentration of 0.05% of IPBC in cosmetics.
However, the following sentence was added to the opinion : "The use of the substance in leave-on products which contain more than 0.02 % necessitates a warning label : "Contains Iodine".
The document was adopted by the plenary.
Clarification of the Opinion of the SCCNFP concerning Hydrogen (carbamide) peroxide in tooth whitening products, doc. n° SCCNFP/0200/99
The SCCNFP recently reviewed the safety of hydrogen (carbamide) peroxide in tooth whitening products following a request to increase the permitted level in Annex III of Directive 76/768/EEC from 0.1 to 3.6%. Subsequently to this review, the SCCNFP adopted an opinion (doc. n° SCCNFP/0058/98) in the 7th Plenary meeting of 17 February 1999 saying that :
* tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"), and that
* the products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
It was the opinion of the Commission services, responsible for the regulation of cosmetic products within the Community, that it would be inappropriate to provide for such an ingredient, with the restrictions specified in the opinion of the SCCNFP, in Directive 76/768/EEC on cosmetic products. In order for the material to be used in cosmetic products, it was proposed that a level should be found which allows free use by the majority of consumers.
The SCCNFP re-evaluated the questions raised and as a result, the committee reconfirmed its opinion concerning hydrogen (carbamide) peroxide in tooth whitening products of 17 February 1999 but decided however to remove the part "during pregnancy or" from the opinion since based on recent toxicokinetic considerations it seems to be unlikely that hydrogen peroxide reaches the foetus.
The document was adopted by the plenary meeting.
Hydrogen peroxide and hydrogen peroxide releasing substances used in oral care products, doc. n° SCCNFP/0158/99
The SCCNFP concluded that, based of the available documentation and in the absence of long term effect studies and with reference to the opinion adopted on the use of hydrogen (carbamide) peroxide in teeth whitening products (doc. SCCNFP/0058/98 and doc. n° SCCNFP/0200/99), oral care products should not contain more than 0.1% hydrogen peroxide. Up to this concentration, these products can be made freely available to the consumer without specific warning statements.
The document was adopted by the plenary meeting.
Strontium Lactate, Nitrate and Polycarboxylate, doc. n° SCCNFO/0044/98
In its opinion of 23.9.98 concerning Strontium Lactate, Nitrate and Polycarboxylate, the SCCNFP made some 'consequences' of a rather legislative than scientific nature. However, it was felt that such consequences fall outside the field of competence of the SCCNFP and therefore, the Committee remove the chapter 'consequences' from its opinion.
The document was adopted in this form by the plenary meeting.
Ketoconazole, doc. n° SCCNFP/0164/99
The Committee was asked to review the safety of Ketoconazole at a maximum concentration of 2 % in both rinse-off and leave-on products, excluding oral care products.
The Committee expressed its concern about :
(i) the pharmacological action of the substance. Ketoconazole is used in drugs as a broad spectrum anti-fungal agent, highly effective in skin infections caused by dermatophytes and yeasts, in dermal candidosis and systemic mycoses.
(ii) the environmental impact (endocrine/anti-androgen effects) of the substance.
However, it was decided to limit the discussion to the mandate received and to respond specifically to the questions asked. Nevertheless the Committee made the following statement :
The SCCNFP expressively stated that this opinion is primarily an answer to a request made by the European Commission and does not cover amongst others its use as a drug or environmental aspects. These aspects have to be clarified by the appropriate Scientific Committees.
The document was adopted with this addendum to the opinion by the plenary.
To conclude its report, Dr. White said that a mandate was received from DG III to review the safety of Methyleugenol and that the evaluation will start as soon as the requested information is received.
3.5 UV Filters
Report of the Co-ordinator
In the absence of the Co-ordinator Dr. Powell, Dr. O'Mahony reported on the work done since the previous plenary meeting. The following issues were discussed :
S75 : Coated Titanium dioxide : a further submission was received. However; the data supplied did not respond to all questions raised by the Working Party. The plenary meeting reminded the Commission that industry must respond specifically to the questions asked.
S16 : 4-Isopropylbenzyl salicylate : By letter of 27 January 1999, COLIPA, The European Cosmetic Toiletry and Perfumery Association, informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate (COLIPA n° S16 - n° 29, part 2 of Annex VII of Directive 76/768/EEC) has ceased the production of this ingredient as UVB filter.
As a consequence, the SCCNFP ceased the evaluation procedure on the use of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations.
However, DG III mandated the Committee to review the safety profile of the substance for use in cosmetic products, other than suntans e.g. as a UV-absorber in order to protect cosmetic products. A report on the out-come will be given in a future meeting.
4. Report of the Chairman
In his report, Prof. Kemper mentioned that he was informed that ISO established a technical committee on cosmetics (n° ISO-TC-217) which will deal with the standardisation of microbiological and chemical test methods for cosmetics.
5. Any Other Business
Sun beds : in the previous plenary meeting, some members expressed their concern about sun beds. The issue was raised here again.
The Chairman said that the issue will be analysed in close co-operation with the Scientific Committee on Medicinal Products and Medicinal Devices. A joint Working Party will be set up as soon as a mandate is received.
Dioxine : Based on the information received from various sides concerning the dioxine crisis in Belgium, Spring 99, the Commission found it irrelevant to mandate the SCCNFP on health issues due to a possible contamination of cosmetic products.
Council of Europe : further to contacts with the Council of Europe, DG XXIV will attend in the future the meetings organised by the Council of Europe in the domain of cosmetics and inform the Committee on the on-going work.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr V. Kapoulas, Mr F. Kemper, Mr J. Parra, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White, Mr L. Celleno external expert, Mrs J.D. Johansen external expert, Mr Ph. Masson external expert, Mr D. O'Mahony external expert, Mrs R. Schumann external expert
Commission :
Mrs B. Alonso DG XXIV, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV Mr G. Fracchia DG XXIV, Mrs E. Orthmann JRC ISPRA
Mr L. Bansil DG III
Mrs U. Faure DG XII
Apologies :
Mr P. Blain Mr B. Lina, Mr N. Loprieno, Mr C.J. Powell
Annex 1 - Scientific Committee on Cosmetic and Non-Food Products, Agenda for the 8th plenary meeting (Brussels, 23 June 1999)
1. Adoption of the agenda
SCCNFP/0192/99
2. Approval of the minutes of the 7th plenary meeting of 17.2.99
SCCNFP/0126/99
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
Basic criteria for the in vitro assessment of percutaneous absorption of cosmetic ingredients
SCCNFP/0167/99 Rev. 3
Present development and validation of adequate alternative methodologies to the use of animals in the safety testing of cosmetics
SCCNFP/0177/99 Rev. 1
Guidelines on the use of human volunteers in skin compatibility testing of finished cosmetic products SCCNFP/0068/98 Rev. 3
Updating of the Notes of guidance for testing of cosmetic ingredients for their safety evaluation
SCCNFP/0119/99 Rev. 3
3.2 Hair Dyes
Report of the Co-ordinator
Draft opinions on :
* A1 - 1,7-Naphthalenediol SCCNFP/0128/99
* A17 - 1-Naphthol SCCNFP/0130/99
* A22 - p-Methylaminophenol SCCNFP/0179/99
* A25 - Hydroxybenzomorpholine SCCNFP/0131/99
* A31 - 2-Methyl-5-hydroxyethylaminophenol SCCNFP/0132/99
* A39 - Phenylmethylpyrazolon SCCNFP/0134/99
* A43 - 1-Hydroxy-3-amino-2,4-dichloro-benzene SCCNFP/0135/99
* A79 - 1,3-Bis-(2,4-diaminophenoxy)propane SCCNFP/0136/99
* A101 - 2,6-Dimethoxy-3,5-pyridinediamine, HCl SCCNFP/0181/99
* A113 - 2,4-Diamino-5-methylphenethol, HCl SCCNFP/0138/99
* A116 - 2,4-Diamino-5-methylphenoxyethanol HCl SCCNFP/0139/99
* B72 - 2-Hydroxyethylpicramic acid SCCNFP/0182/99
* B73 - HC Blue n° 12 SCCNFP/0140/99
* B75 - Hydroxyethyl-2-nitro-p-toluidine SCCNFP/0183/99
* B77 - HC Blue n° 11 SCCNFP/0184/99
* B90 - Hydroxyethyl-2,6-dinitro-p-anisidine SCCNFP/0141/99
* B92 - 6-Nitro-2,5-pyridinediamine SCCNFP/0185/99
* B98 - HC violet n° 2 SCCNFP/0142/99
* B100 - 4-Hydroxypropylamino-3-nitrophenol SCCNFP/0186/99
3.3 Inventory
Report of the Co-ordinator
3.4 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Labelling of fragrance allergens on cosmetic products
SCCNFP/0017/98
Draft opinion on P91 - 3-Iodo-2-propynyl-butyl-carbamite
SCCNFP/0193/99
Opinion on the use of carbamide peroxide in teeth bleaching products
Note from DG III
SCCNFP/0058/98
Opinion on hydrogen peroxide and hydrogen peroxide releasing
Substances used in oral care products
SCCNFP/0158/99
Opinion on Strontium Lactate, Nitrate and Polycarboxylate
SCCNFP/0044/98
Note from DG XXIV/A/3
Opinion on ketoconazole
SCCNFP/0164/99
3.5 UV Filters
Report of the Co-ordinator
4. Report of the Chairman
5. Any other business
Annex 2
Letter dated : Münster, 22 February 1999
From : Professor F. H. Kemper
former Director of the Institute for Pharmacology and Toxicology of the University of Münster
To : Dr Horst Reichenbach
Director-General, DG XXIV
European Commission
Dear Dr Reichenbach,
In the context of deliberations within the European Commission that have come to our attention concerning the preparation of the seventh amendment to the Cosmetic Products Directive 76/768/EEC, the members of the SCCNFP have learned to their dismay that it is planned to discard the substance of the draft seventh amendment as discussed to date. Rather, the idea of further amending the existing legislation has been dropped precisely in the field of alternatives to conventional animal trials - an area which is of vital importance to consumer safety. What this means in plain language is that after 30 June 2000 no further animal experiments will be permitted with an eye to determining the safety of cosmetic products intended for consumers. Besides the interesting detail that this ban will apply only to EU countries (!) - and hence would in my view create serious distortions to competition in this area - I can only warn you against these plans from the scientific perspective.
The members of the SCCNFP, who as we all know represent a multiplicity of scientific and medical specialisations, expressly authorised me, by unanimous decision taken at the plenary meeting of 17 February 1999, to notify you in person of our grave misgivings in this connection. If you proceed to adopt the amendment as planned, the members of the SCCNFP will no longer be in a position to perform evaluations - whose final objective is assessment of the safety implications for consumers - on the basis of the whatever scientific data will still be available in future.
The handful of available evaluated alternative methods to conventional animal trials rule out both (a) the necessary health and toxicological characterisation of the substances in question on the basis of state-of-the-art standards and (b) risk assessment - even of a rudimentary nature - with an eye to consumer safety.
In these circumstances the members of the SCCNFP, while expressly drawing attention to the prerequisites for membership of this scientific advisory body attached to DG XXIV, wish to emphasise that without an appropriate scientific foundation they will no longer be able to exercise a responsible advisory function, i.e. they will no longer be able to endorse whatever rules are adopted in future. Besides the three key terms excellency, independence and transparency - which mainly relate to the qualities of individual members of the Scientific Committee - we must yet again point out in the interest of consumer safety that these prerequisites cannot be met without scientific honesty and integrity. This is the purpose of this letter - besides protecting the EC from the possible consequences of political decisions with a short-term populistic effect but whose long-term impact on consumer safety and health is sure to be negative.
Moreover, it should be noted that scientific findings cannot be delivered "to order" even when generous subsidies are available - as is the case of the Fifth RTD Framework Programme in DG XII ("Cell Factory") for the alternative methods sector. Precisely in the field of alternative methods there have been several cases in recent years where hopes for quick solutions dissipated when subjected to closer scrutiny - eye irritation being one example. Here again the fact remains that we have very little in the way of evaluated, useable and thus scientifically grounded alternative test methods; the table of prospects for alternative methods (cf. Annex) - long recognised by scientists in this field - has lost none of its relevance.
Signed,
Prof. Dr. F.H. KEMPER
The following table represents the tests which could be carried out on cosmetic ingredients or combinations of ingredients to perform a proper safety evaluation.
The tests have been classified on the basis of current scientific knowledge on the possibilities of replacing them partially or totally by non-animal methods.
With sadness, the European Commission and the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers were informed of the passing away of Prof. Y. De Roeck, born Holtzhauer.
Mme De Roeck was awarded several distinctions such as "Chevalier dans l'Ordre des Palmes Academiques" in 1970 followed in 1991 by the order of merit "Officier dans l'Ordre des Palmes Academiques".
At European level, Mme De Roeck created a number of activities, especially on the sectors of marine programmes such as "Arc Atlantique" and international courses on ingredients of cosmetic products. She was a member of the SCCNFP since 1997.
In the name of the SCCNFP, a letter of condolences was sent to her husband, Prof. H. De Roeck, and her family.
The Chairman invited the meeting to stand up for a minute of silence.
1. Adoption of the Agenda (doc. n° SCCNFP/0192/99) (Annex 1)
The agenda was adopted subject to some minor corrections and subject to the insertion of the draft opinions on :
- hydrogen peroxide and hydrogen peroxide releasing substances used in oral care products
- ketoconazole.
2. Approval of the minutes of the 7th plenary meeting of 17 February 1999
doc. n° SCCNFP/0126/99
The minutes were adopted subject to the correction of the typographical errors.
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
In the absence of the Co-ordinator, Prof. Loprieno, the various rapporteurs were asked to present the documents approved by the Working Party and addressed to the plenary meeting for formal adoption.
Draft opinions were prepared on :
Basic criteria for the in vitro assessment of percutaneous absorption of cosmetic products, doc. n° SCCNFP/0167/99 rev. 3
Because of the great variety of in vitro percutaneous absorption studies presented to the SCCNFP in the framework of the safety assessment of cosmetic ingredients, the Committee felt there was a need to formulate minimal criteria for the acceptance of such studies.
The document describes the basic criteria for the in vitro assessment of the percutaneous absorption of a cosmetic ingredient. The principles and basic elements of such studies are addressed.
The meeting adopted the document.
The Chairman proposed to publish this document not only on the web site of the Scientific Committees but also in scientific periodicals to give it the largest possible distribution/publicity.
This was agreed.
Present development and validation of adequate alternative methodologies to the use of animals in safety testing of cosmetics, doc. n° SCCNFP/0177/99 rev. 1
Further to a request from the Commission, the SCCNFP assessed the possibility to replace animal test by alternative methods in the safety evaluation of cosmetic ingredients. The document, addressed to the Commission to answer questions of a scientific nature, represents the state-of-the-art in this domain and indicates as well those end-points for which alternative methods are not yet available.
In the margin of the discussion, the meeting expressed its full support to the letter sent by Chairman, Prof. Kemper, on 22.2.99 to Dr. H. Reichenbach, Director General of DG XXIV concerning animal tests. This letter is annexed to the document (Annex 2).
Guidelines on the use of human volunteers in compatibility testing of finished cosmetic products, doc. n° SCCNFP/0068/98, rev. 3
Although there is no legal requirement that finished cosmetic products have to be tested before marketing, confirmatory compatibility tests of a finished cosmetic product in humans may be needed ethically and consequently scientifically, provided that the toxicological profile of its ingredients is available.
The plenary meeting adopted these guidelines which take into consideration the ethical and practical aspects when human volunteers are involved in studies organised to assess skin and mucous membrane compatibility of finished cosmetic products.
Updating of the Notes of Guidance for testing of cosmetic ingredients for their safety evaluation, doc. n° SCCNFP/0119/99, rev. 3
Dr. Drion presented the document and highlighted the various changes with respect to the previous version.
Subject to some minor corrections, the document was adopted by the plenary meeting.
To put in perspective the importance of these Notes of Guidance, Dr. Bansil stated that these Notes not only give clear directions to industry of what is requested from them but also will be used by DG III as a basis for their work on international harmonisation of regulations in the domain of cosmetic products.
3.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that a series of draft opinions were prepared by the Working Party and now tabled for formal adoption. Prior to this exercise, he made some general statements, namely that (i) not all sensitisation studies were performed according to the present OECD Guidelines but that no new studies are requested provided that cosmetic products containing such a substance carry a label warning of a potential risk of sensitisation and (ii) that the substance name on the cover of the opinion should be the INCI name to bring the opinions in line with the Inventory.
Draft opinions were prepared on :
* A1 - 1,7-Naphthalenediol SCCNFP/0128/99
* A17 - 1-Naphthol SCCNFP/0130/99
* A22 - p-Methylaminophenol SCCNFP/0179/99
* A25 - Hydroxybenzomorpholine SCCNFP/0131/99
* A31 - 2-Methyl-5-hydroxyethylaminophenol SCCNFP/0132/99
* A39 - Phenylmethylpyrazolon SCCNFP/0134/99
* A43 - 1-Hydroxy-3-amino-2,4-dichloro-benzene SCCNFP/0135/99
* A79 - 1,3-Bis-(2,4-diaminophenoxy)propane SCCNFP/0136/99
* A101 - 2,6-Dimethoxy-3,5-pyridinediamine, HCl SCCNFP/0181/99
* A113 - 2,4-Diamino-5-methylphenethol, HCl SCCNFP/0138/99
* A116 - 2,4-Diamino-5-methylphenoxyethanol HCl SCCNFP/0139/99
* B72 - 2-Hydroxyethylpicramic acid SCCNFP/0182/99
* B73 - HC Blue n° 12 SCCNFP/0140/99
* B75 - Hydroxyethyl-2-nitro-p-toluidine SCCNFP/0183/99
* B77 - HC Blue n° 11 SCCNFP/0184/99
* B90 - Hydroxyethyl-2,6-dinitro-p-anisidine SCCNFP/0141/99
* B92 - 6-Nitro-2,5-pyridinediamine SCCNFP/0185/99
* B98 - HC violet n° 2 SCCNFP/0142/99
* B100 - 4-Hydroxypropylamino-3-nitrophenol SCCNFP/0186/99
These 19 opinions were adopted with a classification 1 ( may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in each case). However, cosmetic products containing these substances, except for A39, B72 and B98, should carry a label warning of a risk of sensitisation.
It was also suggested that for all future opinions on hair dyes, when there is a statement on sensitisation, a warning should be prominent on the package saying that hair dye chemicals can cause allergic skin reactions, which can be severe.
3.3 Inventory
Report of the Co-ordinator
Prof. Parra reported on the on-going work on the 1st update of the inventory. He mentioned that a complete draft is not yet available as a number of issues still need to be discussed within the Working Party and with COLIPA.
Amongst others, the following 'priority' items are on the agenda : guidelines for botanical ingredients and derivatives, major problems encountered while processing the new entries, nomenclature conventions for colorants and hair dyes.
It is intended to begin with bilateral consultations on this subject in the near future.
3.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White mentioned the work done since the previous plenary meeting, and in particular on the labelling of fragrance allergens.
In the context of this work, industry was invited and afforded the opportunity to contribute to the scientific review process concerning fragrance ingredient allergy. The perceived size of the problem as well as its definition were discussed. There was agreement on the importance of primary prevention as the crucial parameter in addressing fragrance ingredients allergy. It was also agreed that secondary prevention of allergic reactions was also very important and to a certain extend a common position was reached concerning secondary prevention : to provide the necessary information to the consumer. While the SCCNFP preferred the selective labelling of recognised fragrance ingredients, industry felt that the other systems as well as such ingredient listing, should be looked at, including bar or numerical code on the package or an ingredients data base accessible to dermatologists.
However, due to repercussions from various quarters on the draft opinion and although there was agreement in general, the Committee decided to re-style the document in such a way that it better corresponds to the questions asked in the mandate. The mandate will be inserted as well as a chapter on the background of the issue. The reformatted document on fragrance identification will form part of a continuing assessment of fragrance ingredient safety.
The plenary meeting thus adopted this situation and the underlying facts as an interim position on fragrance allergy.
Draft opinions were prepared and presented on :
P91 : 3-Iodo-2-propynyl-butyl-carbamate (IPBC), doc. n° SCCNFP/0193/99
An opinion on the use of IPBC as a preservative was adopted during the plenary meeting of 24.6.97. Because of concern with respect to potential biological effects on the endocrine system (high percutaneous absorption rate and Iodine content), a special investigation to estimate the possible influences on endocrine functions was requested and performed.
The rapporteur presented the draft revised opinion and mentioned that the study shows that the percutaneous absorption, recently investigated with modern methodology, is much less than initially stated and that consequently an absorption of Iodine in this range would not cause in general adverse effects up to a concentration of 0.05% of IPBC in cosmetics.
However, the following sentence was added to the opinion : "The use of the substance in leave-on products which contain more than 0.02 % necessitates a warning label : "Contains Iodine".
The document was adopted by the plenary.
Clarification of the Opinion of the SCCNFP concerning Hydrogen (carbamide) peroxide in tooth whitening products, doc. n° SCCNFP/0200/99
The SCCNFP recently reviewed the safety of hydrogen (carbamide) peroxide in tooth whitening products following a request to increase the permitted level in Annex III of Directive 76/768/EEC from 0.1 to 3.6%. Subsequently to this review, the SCCNFP adopted an opinion (doc. n° SCCNFP/0058/98) in the 7th Plenary meeting of 17 February 1999 saying that :
* tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"), and that
* the products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
It was the opinion of the Commission services, responsible for the regulation of cosmetic products within the Community, that it would be inappropriate to provide for such an ingredient, with the restrictions specified in the opinion of the SCCNFP, in Directive 76/768/EEC on cosmetic products. In order for the material to be used in cosmetic products, it was proposed that a level should be found which allows free use by the majority of consumers.
The SCCNFP re-evaluated the questions raised and as a result, the committee reconfirmed its opinion concerning hydrogen (carbamide) peroxide in tooth whitening products of 17 February 1999 but decided however to remove the part "during pregnancy or" from the opinion since based on recent toxicokinetic considerations it seems to be unlikely that hydrogen peroxide reaches the foetus.
The document was adopted by the plenary meeting.
Hydrogen peroxide and hydrogen peroxide releasing substances used in oral care products, doc. n° SCCNFP/0158/99
The SCCNFP concluded that, based of the available documentation and in the absence of long term effect studies and with reference to the opinion adopted on the use of hydrogen (carbamide) peroxide in teeth whitening products (doc. SCCNFP/0058/98 and doc. n° SCCNFP/0200/99), oral care products should not contain more than 0.1% hydrogen peroxide. Up to this concentration, these products can be made freely available to the consumer without specific warning statements.
The document was adopted by the plenary meeting.
Strontium Lactate, Nitrate and Polycarboxylate, doc. n° SCCNFO/0044/98
In its opinion of 23.9.98 concerning Strontium Lactate, Nitrate and Polycarboxylate, the SCCNFP made some 'consequences' of a rather legislative than scientific nature. However, it was felt that such consequences fall outside the field of competence of the SCCNFP and therefore, the Committee remove the chapter 'consequences' from its opinion.
The document was adopted in this form by the plenary meeting.
Ketoconazole, doc. n° SCCNFP/0164/99
The Committee was asked to review the safety of Ketoconazole at a maximum concentration of 2 % in both rinse-off and leave-on products, excluding oral care products.
The Committee expressed its concern about :
(i) the pharmacological action of the substance. Ketoconazole is used in drugs as a broad spectrum anti-fungal agent, highly effective in skin infections caused by dermatophytes and yeasts, in dermal candidosis and systemic mycoses.
(ii) the environmental impact (endocrine/anti-androgen effects) of the substance.
However, it was decided to limit the discussion to the mandate received and to respond specifically to the questions asked. Nevertheless the Committee made the following statement :
The SCCNFP expressively stated that this opinion is primarily an answer to a request made by the European Commission and does not cover amongst others its use as a drug or environmental aspects. These aspects have to be clarified by the appropriate Scientific Committees.
The document was adopted with this addendum to the opinion by the plenary.
To conclude its report, Dr. White said that a mandate was received from DG III to review the safety of Methyleugenol and that the evaluation will start as soon as the requested information is received.
3.5 UV Filters
Report of the Co-ordinator
In the absence of the Co-ordinator Dr. Powell, Dr. O'Mahony reported on the work done since the previous plenary meeting. The following issues were discussed :
S75 : Coated Titanium dioxide : a further submission was received. However; the data supplied did not respond to all questions raised by the Working Party. The plenary meeting reminded the Commission that industry must respond specifically to the questions asked.
S16 : 4-Isopropylbenzyl salicylate : By letter of 27 January 1999, COLIPA, The European Cosmetic Toiletry and Perfumery Association, informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate (COLIPA n° S16 - n° 29, part 2 of Annex VII of Directive 76/768/EEC) has ceased the production of this ingredient as UVB filter.
As a consequence, the SCCNFP ceased the evaluation procedure on the use of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations.
However, DG III mandated the Committee to review the safety profile of the substance for use in cosmetic products, other than suntans e.g. as a UV-absorber in order to protect cosmetic products. A report on the out-come will be given in a future meeting.
4. Report of the Chairman
In his report, Prof. Kemper mentioned that he was informed that ISO established a technical committee on cosmetics (n° ISO-TC-217) which will deal with the standardisation of microbiological and chemical test methods for cosmetics.
5. Any Other Business
Sun beds : in the previous plenary meeting, some members expressed their concern about sun beds. The issue was raised here again.
The Chairman said that the issue will be analysed in close co-operation with the Scientific Committee on Medicinal Products and Medicinal Devices. A joint Working Party will be set up as soon as a mandate is received.
Dioxine : Based on the information received from various sides concerning the dioxine crisis in Belgium, Spring 99, the Commission found it irrelevant to mandate the SCCNFP on health issues due to a possible contamination of cosmetic products.
Council of Europe : further to contacts with the Council of Europe, DG XXIV will attend in the future the meetings organised by the Council of Europe in the domain of cosmetics and inform the Committee on the on-going work.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr V. Kapoulas, Mr F. Kemper, Mr J. Parra, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White, Mr L. Celleno external expert, Mrs J.D. Johansen external expert, Mr Ph. Masson external expert, Mr D. O'Mahony external expert, Mrs R. Schumann external expert
Commission :
Mrs B. Alonso DG XXIV, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV Mr G. Fracchia DG XXIV, Mrs E. Orthmann JRC ISPRA
Mr L. Bansil DG III
Mrs U. Faure DG XII
Apologies :
Mr P. Blain Mr B. Lina, Mr N. Loprieno, Mr C.J. Powell
Annex 1 - Scientific Committee on Cosmetic and Non-Food Products, Agenda for the 8th plenary meeting (Brussels, 23 June 1999)
1. Adoption of the agenda
SCCNFP/0192/99
2. Approval of the minutes of the 7th plenary meeting of 17.2.99
SCCNFP/0126/99
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
Basic criteria for the in vitro assessment of percutaneous absorption of cosmetic ingredients
SCCNFP/0167/99 Rev. 3
Present development and validation of adequate alternative methodologies to the use of animals in the safety testing of cosmetics
SCCNFP/0177/99 Rev. 1
Guidelines on the use of human volunteers in skin compatibility testing of finished cosmetic products SCCNFP/0068/98 Rev. 3
Updating of the Notes of guidance for testing of cosmetic ingredients for their safety evaluation
SCCNFP/0119/99 Rev. 3
3.2 Hair Dyes
Report of the Co-ordinator
Draft opinions on :
* A1 - 1,7-Naphthalenediol SCCNFP/0128/99
* A17 - 1-Naphthol SCCNFP/0130/99
* A22 - p-Methylaminophenol SCCNFP/0179/99
* A25 - Hydroxybenzomorpholine SCCNFP/0131/99
* A31 - 2-Methyl-5-hydroxyethylaminophenol SCCNFP/0132/99
* A39 - Phenylmethylpyrazolon SCCNFP/0134/99
* A43 - 1-Hydroxy-3-amino-2,4-dichloro-benzene SCCNFP/0135/99
* A79 - 1,3-Bis-(2,4-diaminophenoxy)propane SCCNFP/0136/99
* A101 - 2,6-Dimethoxy-3,5-pyridinediamine, HCl SCCNFP/0181/99
* A113 - 2,4-Diamino-5-methylphenethol, HCl SCCNFP/0138/99
* A116 - 2,4-Diamino-5-methylphenoxyethanol HCl SCCNFP/0139/99
* B72 - 2-Hydroxyethylpicramic acid SCCNFP/0182/99
* B73 - HC Blue n° 12 SCCNFP/0140/99
* B75 - Hydroxyethyl-2-nitro-p-toluidine SCCNFP/0183/99
* B77 - HC Blue n° 11 SCCNFP/0184/99
* B90 - Hydroxyethyl-2,6-dinitro-p-anisidine SCCNFP/0141/99
* B92 - 6-Nitro-2,5-pyridinediamine SCCNFP/0185/99
* B98 - HC violet n° 2 SCCNFP/0142/99
* B100 - 4-Hydroxypropylamino-3-nitrophenol SCCNFP/0186/99
3.3 Inventory
Report of the Co-ordinator
3.4 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Labelling of fragrance allergens on cosmetic products
SCCNFP/0017/98
Draft opinion on P91 - 3-Iodo-2-propynyl-butyl-carbamite
SCCNFP/0193/99
Opinion on the use of carbamide peroxide in teeth bleaching products
Note from DG III
SCCNFP/0058/98
Opinion on hydrogen peroxide and hydrogen peroxide releasing
Substances used in oral care products
SCCNFP/0158/99
Opinion on Strontium Lactate, Nitrate and Polycarboxylate
SCCNFP/0044/98
Note from DG XXIV/A/3
Opinion on ketoconazole
SCCNFP/0164/99
3.5 UV Filters
Report of the Co-ordinator
4. Report of the Chairman
5. Any other business
Annex 2
Letter dated : Münster, 22 February 1999
From : Professor F. H. Kemper
former Director of the Institute for Pharmacology and Toxicology of the University of Münster
To : Dr Horst Reichenbach
Director-General, DG XXIV
European Commission
Dear Dr Reichenbach,
In the context of deliberations within the European Commission that have come to our attention concerning the preparation of the seventh amendment to the Cosmetic Products Directive 76/768/EEC, the members of the SCCNFP have learned to their dismay that it is planned to discard the substance of the draft seventh amendment as discussed to date. Rather, the idea of further amending the existing legislation has been dropped precisely in the field of alternatives to conventional animal trials - an area which is of vital importance to consumer safety. What this means in plain language is that after 30 June 2000 no further animal experiments will be permitted with an eye to determining the safety of cosmetic products intended for consumers. Besides the interesting detail that this ban will apply only to EU countries (!) - and hence would in my view create serious distortions to competition in this area - I can only warn you against these plans from the scientific perspective.
The members of the SCCNFP, who as we all know represent a multiplicity of scientific and medical specialisations, expressly authorised me, by unanimous decision taken at the plenary meeting of 17 February 1999, to notify you in person of our grave misgivings in this connection. If you proceed to adopt the amendment as planned, the members of the SCCNFP will no longer be in a position to perform evaluations - whose final objective is assessment of the safety implications for consumers - on the basis of the whatever scientific data will still be available in future.
The handful of available evaluated alternative methods to conventional animal trials rule out both (a) the necessary health and toxicological characterisation of the substances in question on the basis of state-of-the-art standards and (b) risk assessment - even of a rudimentary nature - with an eye to consumer safety.
In these circumstances the members of the SCCNFP, while expressly drawing attention to the prerequisites for membership of this scientific advisory body attached to DG XXIV, wish to emphasise that without an appropriate scientific foundation they will no longer be able to exercise a responsible advisory function, i.e. they will no longer be able to endorse whatever rules are adopted in future. Besides the three key terms excellency, independence and transparency - which mainly relate to the qualities of individual members of the Scientific Committee - we must yet again point out in the interest of consumer safety that these prerequisites cannot be met without scientific honesty and integrity. This is the purpose of this letter - besides protecting the EC from the possible consequences of political decisions with a short-term populistic effect but whose long-term impact on consumer safety and health is sure to be negative.
Moreover, it should be noted that scientific findings cannot be delivered "to order" even when generous subsidies are available - as is the case of the Fifth RTD Framework Programme in DG XII ("Cell Factory") for the alternative methods sector. Precisely in the field of alternative methods there have been several cases in recent years where hopes for quick solutions dissipated when subjected to closer scrutiny - eye irritation being one example. Here again the fact remains that we have very little in the way of evaluated, useable and thus scientifically grounded alternative test methods; the table of prospects for alternative methods (cf. Annex) - long recognised by scientists in this field - has lost none of its relevance.
Signed,
Prof. Dr. F.H. KEMPER
The following table represents the tests which could be carried out on cosmetic ingredients or combinations of ingredients to perform a proper safety evaluation.
The tests have been classified on the basis of current scientific knowledge on the possibilities of replacing them partially or totally by non-animal methods.
| TESTING OF COSMETIC INGREDIENTS FOR SAFETY EVALUATION | |
| B.1. Good prospect for alternatives | - skin
irritation - percutaneous absorption - photoirritation - eye irritation |
| B.2. Some prospect for alternatives | - skin sensitisation |
| B.3. Little prospect for alternatives | -
acute toxicity - systemic toxicity - developmental toxicity - mutagenicity in vivo - immunotoxicity - cancerogenicity - neurotoxicity - reproductive toxicity |
