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Directorate-General for Health and Food Safety
The Chairman, Prof.
Kemper, welcomed the
participants and in particular
Dr. Rémi Glomot and Dr. Daniel
O'Mahony, who have been
appointed by the Commission as
members of the SCCNFP.
He also introduced as guest speaker Dr. Angel Ruiz de Valbuena Paredes who was invited for a presentation of the activities of the Committee of Experts on Cosmetics Products of the Council of Europe.
Apologies were received from some members of the SCCNFP (see attendance list)
1. Adoption of the Agenda (doc. n° SCCNFP/0283/00) (Annex 1)
The agenda was adopted.
2. Presentation of the activities of the Committee of Experts on Cosmetics Products of the Council of Europe
Dr. Ruiz de Valbuena Paredes presented the structure and aims of the Council of Europe. Particular attention was given to the Partial Agreement in the Social and Public Health Field, the framework in which the Committee of Experts on Cosmetic Product, of which he is the secretary, operates.
He highlighted the Terms of Reference and the Working Procedures of the committee and gave an overview of its activities and publications.
The presentation was followed by a discussion which focussed mainly on the mandate of the committee and on seeking ways to collaborate on issues of mutual interest. In order to avoid ‘double work' it is indispensable to improve the communication between the Council of Europe and the European Commission/SCCNFP.
This should preferably be performed following the chain DG SANCO, Unit B2 to the Council of Europe, operated by a Commission scientist and, if necessary, in a step by step procedure by members of the SCCNFP. Most important is a mutual flow of information.
3. Presentation of the Future of Scientific Advice in the EU and of the White Paper on Food Safety
Prof. Kemper briefly illustrated both documents on the future of scientific advice and on food safety. The first one is a response to a request on how the European Union might improve the provision of scientific advice. The latter is the response of the European Commission to the need to guarantee the highest possible level of food safety.
Only 5 scientific committees are involved in the food safety authority. The SCCNFP forms not part of them. Prof. Kemper said he was asked by the Commission to comment, from the point of view of the SCCNFP, on both papers in a memorandum - which should also include thoughts on the future of the SCCNFP - to be presented by the end of March. He said that he will circulate in the coming days a draft among the members of the committee for further comments.
4. Declaration of interest
No interests were declared.
5. Approval of the minutes of the 10th plenary meeting of 8 December 1999
doc. n° SCCNFP/0265/99
The minutes were adopted, together with special thanks to the secretariat.
6. SCCNFP - Specific Working Parties
6.1 Alternatives
Report of the Co-ordinator
Prof. Loprieno said that the Working Party prepared two documents, one on the use of human volunteers in the testing of cosmetic ingredients, the other on the SCCNFP Basic Requirements for the testing of cosmetic ingredients for their safety evaluation.
Both documents are tabled for formal adoption.
Draft opinions on :
SCCNFP basic requirements for the testing of cosmetic ingredients for their safety evaluation, doc. n° SCCNFP/0308/00
This opinion is directly addressed to the cosmetic industry and sets out the basic requirements a safety file must fulfil in view of its evaluation by the SCCNFP.
The paper requires as well that in vitro studies are performed for those toxicological endpoints where alternatives to animal testing exist which have been validated by ECVAM and approved by the SCCNFP. These studies are : the 3T3 NRU PT test and the in vitro assessment of percutaneous absorption.
Moreover, the paper states that the use of human volunteers in confirmatory or predictive tests are subject to ethical concern as a risk for their safety cannot be excluded.
The opinion was adopted and will be inserted in the Notes of Guidance.
The predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, doc. n° SCCNFP/0120/99
The document considers the animals assays and the use of human volunteers for predictive allergenicity tests.
The document concludes that the animal assays to evaluate the cutaneous sensitising potential of cosmetic ingredients are reliable and their performance is well documented. Their efficiency with regard to the testing of mixtures of ingredients is less well documented.
However, serious ethical questions arise with the use of human volunteers as these tests involve the possibility and therefore the risk to induce a long lasting or permanent immunologic sensitisation in the individual.
No validated alternative predictive contact allergenicity test is currently available.
The opinion was adopted and will be inserted in the SCCNFP's Notes of Guidance.
6.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that the Working Party finalised draft opinions on hair dye n° C46, on amino acids derived from human hair hydrolysates with regard to the transmission of Creutzfeldt-Jakob-Disease, transmissible human spongiform encephalopathies and viral diseases and on the use of 2,4-DPO when used in cosmetic hair care formulations to prevent development of androgenic alopecia. The documents need further secretarial work and will therefore be presented during the next plenary meeting for formal adoption.
Regarding the elucidations asked by the Austrian Delegation to the Committee on Adaptation to Technical Progress of the Annexes to the cosmetics Directive (CAPT, DG ENTR) on some recently adopted opinions on hair dyes, Prof. Andersen said that the Working Party started to prepare a reply. Only the questions concerning mutagenicity remain and will be discussed during the next WP meeting.
Draft opinions on :
* A15 m-Aminophenol SCCNFP/0231/99
* A19 2,7-Naphthalenediol SCCNFP/0232/99
* A99 2,6-Dihydroxy-3,4-dimethylpyridine SCCNFP/0229/99
* B51 4-Amino-3-nitrophenol SCCNFP/0234/99
* B55 2-Amino-3-nitrophenol SCCNFP/0235/99
These 5 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 A19, should carry a label warning of a risk of sensitisation.
In the margin of the discussion, Prof. Andersen mentioned that opinions are now adopted on most of the hair dyes for which a safety file was received. For a series of hair dyes, additional data has been requested from industry. According to Dr Norgaard, the representative from DG ENTR, industry is using about 350 hair dyes and safety files were submitted on 140 of them.
If the Commission would be required to introduce a positive list on hair dyes, this would involve an additional submission from industry of about 210 safety files to be evaluated by the SCCNFP within a relative short time.
An alternative to the positive list would be the inclusion in Annex III to the cosmetics directive of those hair dyes on which the SCCNFP has adopted an opinion.
Dr. Norgaard said his service is considering both possibilities and might start discussion with the Member States later this year.
6.3 Inventory
Report of the Co-ordinator
Prof. Parra said that, since the draft 1st update of the inventory was received mid-December 1999, two Working Party meetings were organised to verify to which extent the various modifications discussed and agreed upon between the SCCNFP and COLIPA, have been incorporated.
As a result of these WP meetings, a working document, doc. n° SCCNFP/301/00, on the revision of the European Cosmetic Inventory was prepared and tabled for formal adoption by the Committee. The paper contains all the information to be incorporated and modifications to be made to the 1st and/or future updates.
The document was adopted by the SCCNFP and will serve as the basis for discussion with COLIPA during the next WP meeting of 23.3.2000. It is the aim of the Committee to conclude their work on the issue and to formally adopt an opinion concerning the 1st update during its plenary meeting of 28 June 2000.
6.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White reminded the plenary briefly about the mandate received concerning the safety of perfumery materials. He said that the Committee had decided to split this mandate into two parts, namely (i) the identification of those fragrance ingredients which are of concern as allergens for the consumer, (part a - chemically identified substances; part b - natural compounds containing unknown allergens) and (ii) opinions on the adoption of industry prohibited substances into Annex II and of industry restricted substances into Annex III of the Cosmetics Directive 76/768/EEC. An opinion on the first part (a) of the mandate was adopted during the 10th plenary meeting of 8.12.1999. In the frame of part one (b) of the mandate, the safety of oak moss and of tree moss will be reviewed.
Prior to initiating the second phase on the ‘Annex II' and ‘Annex III'-substances, the Working Party firstly considered the 'quenching phenomenon'. The Co-ordinator prepared a position paper on the issue which was tabled for formal adoption. A position on quenching is important as the inclusion of some chemicals in either Annex II or Annex III might depend on it.
Finally, he said that the work on the polycyclic musk is in its final stage and that draft opinions will be presented soon.
Draft position paper on the phenomenon of quenching, doc. n° SCCNFP/0294/00
The paper examines the evidence both for and against quenching, with particular relevance to the current understanding of the chemistry and biology of allergic contact dermatitis (ACD). It provides a reminder of the original observations and reviews the 3 points at which quenching might operate, namely at the chemical level, during the induction of skin sensitisation or during the elicitation of ACD.
The paper states that the existence of quenching of certain fragrance allergens by other specific fragrance compounds should be regarded as a hypothesis only.
The document was adopted by the SCCNFP.
Draft opinion on the safety of tattoos, doc. n° SCCNFP/0296/00
The recitals of the original Directive 76/768/EEC demonstrate that tattoos do not fall under the Cosmetics Directive. Although it would therefore not be appropriate to review the safety of tattoos within their remit on cosmetic products, the SCCNFP was requested to review the safety of tattoos as the issue may fall under their competence in their responsibility for non-food products. Moreover, the tattooing technique can be and is used for ‘permanent cosmetic decoration' e.g. on eye brows, for lip liner.
In response to this request, a draft opinion was prepared which considers two main items, namely the dyes used and the hygiene aspects (e.g. instruments used, transmission of infective agents). The document states that the substances used in these dyes are difficult to identify as they are very often marketed under fantasy names. However, for an adequate assessment of their toxicology, it is necessary to know the chemical identity of these colours and pigments.
The paper recommends that the identity of these substances - a provisional list is annexed - and materials (e.g., tools and appliances) used in the procedure be obtained so that a formal assessment can take place.
The document was adopted by the SCCNFP.
6.5 UV Filters
Report of the Co-ordinator
Dr. O'Mahony reported on the work done since the previous plenary meeting. He said that the requested information on Titanium dioxide was received and that it is at present being evaluated by the rapporteur.
The Working Party discussed as well two draft opinions on Titanium dioxide with a very specific coating. Additional data has been asked from industry.
S74, Benzylidene malonate polysiloxane : further to a discussion during a meeting of the Committee on Adaptation to Technical Progress concerning the draft 24th Commission Directive on the adaptation to technical progress of the Annexes to the Cosmetics Directive, some Members States raised several points on which they required additional information from the SCCNFP. These questions were discussed by the Working Party and a reply to the CAPT was prepared.
Dr. O'Mahony said that the questions asked were not of such a nature that the issue be discussed by the plenary meeting and requiring a formal adaptation. The members agreed with this procedure.
7. Report of the Chairman
* Working Party on Detergents : as decided during previous meeting, the Committee has set up a Working Party on detergents and similar household products. Since the consultation of the SCCNFP on safety aspects in relation with these consumer products is at present not mandatory, the committee will act according to Article 2.4 of Commission Decision 97/579/EC setting up the SC's. The article states that "the Scientific Committees may draw the Commission's attention to any specific or emerging problem falling within their remit in matters of consumer health and food safety.".
The members of the WP are : Prof. P. Elsner, Prof. V. Kapoulas, Prof. F. Kemper, Prof. N. Loprieno, Prof. J. Parra, Prof. V. Rogiers, Prof. T. Sanner, Prof. J. Vives Rego and Dr. I. White.
A meeting of the WP will be organised before next plenary meeting.
* Classification of substances : As the present classification system of substances proved to be unsatisfactory, a revised system was adopted. The main difference with the actual system is that a classification '3' is added. Classification 3 means : substance under consideration/evaluation but already in use and on the market for an extended period may remain under special provisions but only for a limited time which is recommended by the SCCNFP depending on the content of the safety data submitted.
* 7th Amendment : the representative of DG ENTR briefly informed the committee about the state of the file. He said that the draft is still in inter-service consultation and therefore not available. In its present form, it only deals with the animal testing issue.
* Resignation Prof. Blain (UK) : Prof. Kemper informed the committee about a letter the Commission received from Prof. Peter Blain sending in his resignation as a member of the SCCNFP.
8. Any Other Business
* Skin sensitisation testing, methodological considerations (ECETOC TR n° 78) : Copies were distributed for information. Prof. Kemper mentioned that an ECETOC Task Force is presently working on a monograph on skin sensitisation. The methodological considerations will be addressed in the first part of the paper, potency and risk assessment in the second part.
* Training course on safety assessment of cosmetics in the EU : Prof. Rogiers, who is organising the course in Brussels from 10 to 15 April 2000, briefly presented its main objectives.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr R. Glomot, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr D. O'Mahony, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mrs L. Benali DG SANCO, Mrs S. Clarke DG SANCO, Mrs M. de Solà DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mr A. Van Elst DG SANCO
Guest speaker : Mr A. Ruiz de Valbuena Council of Europe
Apologies : Mr P. Blain
Annex 1
Scientific Committee on Cosmetic and Non-Food Products - Agenda for the 11th plenary meeting (Brussels, 17 February 2000)
1. Adoption of the agenda SCCNFP/0283/99
2. Presentation of the activities of the Committee of Experts on Cosmetic Products of the Council of Europe
Dr. Angel Ruiz de Valbuena Paredes
3. Presentation of the 'Future of Scientific Advice in the EU' and of the ‘White Paper on Food Safety'
4. Declaration of interest
5. Approval of the minutes of the 10th plenary meeting of 8.12.99 SCCNFP/0265/99
6. SCCNFP - Specific Working Parties
6.1 Alternatives
Report of the Co-ordinator
Draft opinion on :
* SCCNFP basic requirements for testing cosmetic ingredients SCCNFP/0308/00 for their safety evaluation
* The predictive testing of potentially cutaneous sensitising
cosmetic ingredients or mixtures of ingredients SCCNFP/0120/99
6.2 Hair Dyes
Report of the Co-ordinator
Draft opinions on :
* A15 m-Aminophenol SCCNFP/0231/99
* A19 2,7-Naphthalenediol SCCNFP/0232/99
* A99 2,6-Dihydroxy-3,4-dimethylpyridine SCCNFP/0229/99
* B51 4-Amino-3-nitrophenol SCCNFP/0234/99
* B55 2-Amino-3-nitrophenol SCCNFP/0235/99
6.3 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft position paper on the phenomenon of quenching SCCNFP/0294/00
Draft opinion on the safety of tattoos SCCNFP/0296/00
6.4 Inventory
Report of the Co-ordinator
Working document concerning the revision of the European Cosmetic
Inventory SCCNFP/301/00
6.5 UV Filters
Report of the Co-ordinator
7. Report of the Chairman
* Classification of substances SCCNFP/0297/00
8. Any other business
* Skin sensitisation testing : methodological considerations (ECETOC Technical Report n° 78) - distribution of the document for information
He also introduced as guest speaker Dr. Angel Ruiz de Valbuena Paredes who was invited for a presentation of the activities of the Committee of Experts on Cosmetics Products of the Council of Europe.
Apologies were received from some members of the SCCNFP (see attendance list)
1. Adoption of the Agenda (doc. n° SCCNFP/0283/00) (Annex 1)
The agenda was adopted.
2. Presentation of the activities of the Committee of Experts on Cosmetics Products of the Council of Europe
Dr. Ruiz de Valbuena Paredes presented the structure and aims of the Council of Europe. Particular attention was given to the Partial Agreement in the Social and Public Health Field, the framework in which the Committee of Experts on Cosmetic Product, of which he is the secretary, operates.
He highlighted the Terms of Reference and the Working Procedures of the committee and gave an overview of its activities and publications.
The presentation was followed by a discussion which focussed mainly on the mandate of the committee and on seeking ways to collaborate on issues of mutual interest. In order to avoid ‘double work' it is indispensable to improve the communication between the Council of Europe and the European Commission/SCCNFP.
This should preferably be performed following the chain DG SANCO, Unit B2 to the Council of Europe, operated by a Commission scientist and, if necessary, in a step by step procedure by members of the SCCNFP. Most important is a mutual flow of information.
3. Presentation of the Future of Scientific Advice in the EU and of the White Paper on Food Safety
Prof. Kemper briefly illustrated both documents on the future of scientific advice and on food safety. The first one is a response to a request on how the European Union might improve the provision of scientific advice. The latter is the response of the European Commission to the need to guarantee the highest possible level of food safety.
Only 5 scientific committees are involved in the food safety authority. The SCCNFP forms not part of them. Prof. Kemper said he was asked by the Commission to comment, from the point of view of the SCCNFP, on both papers in a memorandum - which should also include thoughts on the future of the SCCNFP - to be presented by the end of March. He said that he will circulate in the coming days a draft among the members of the committee for further comments.
4. Declaration of interest
No interests were declared.
5. Approval of the minutes of the 10th plenary meeting of 8 December 1999
doc. n° SCCNFP/0265/99
The minutes were adopted, together with special thanks to the secretariat.
6. SCCNFP - Specific Working Parties
6.1 Alternatives
Report of the Co-ordinator
Prof. Loprieno said that the Working Party prepared two documents, one on the use of human volunteers in the testing of cosmetic ingredients, the other on the SCCNFP Basic Requirements for the testing of cosmetic ingredients for their safety evaluation.
Both documents are tabled for formal adoption.
Draft opinions on :
SCCNFP basic requirements for the testing of cosmetic ingredients for their safety evaluation, doc. n° SCCNFP/0308/00
This opinion is directly addressed to the cosmetic industry and sets out the basic requirements a safety file must fulfil in view of its evaluation by the SCCNFP.
The paper requires as well that in vitro studies are performed for those toxicological endpoints where alternatives to animal testing exist which have been validated by ECVAM and approved by the SCCNFP. These studies are : the 3T3 NRU PT test and the in vitro assessment of percutaneous absorption.
Moreover, the paper states that the use of human volunteers in confirmatory or predictive tests are subject to ethical concern as a risk for their safety cannot be excluded.
The opinion was adopted and will be inserted in the Notes of Guidance.
The predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients, doc. n° SCCNFP/0120/99
The document considers the animals assays and the use of human volunteers for predictive allergenicity tests.
The document concludes that the animal assays to evaluate the cutaneous sensitising potential of cosmetic ingredients are reliable and their performance is well documented. Their efficiency with regard to the testing of mixtures of ingredients is less well documented.
However, serious ethical questions arise with the use of human volunteers as these tests involve the possibility and therefore the risk to induce a long lasting or permanent immunologic sensitisation in the individual.
No validated alternative predictive contact allergenicity test is currently available.
The opinion was adopted and will be inserted in the SCCNFP's Notes of Guidance.
6.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that the Working Party finalised draft opinions on hair dye n° C46, on amino acids derived from human hair hydrolysates with regard to the transmission of Creutzfeldt-Jakob-Disease, transmissible human spongiform encephalopathies and viral diseases and on the use of 2,4-DPO when used in cosmetic hair care formulations to prevent development of androgenic alopecia. The documents need further secretarial work and will therefore be presented during the next plenary meeting for formal adoption.
Regarding the elucidations asked by the Austrian Delegation to the Committee on Adaptation to Technical Progress of the Annexes to the cosmetics Directive (CAPT, DG ENTR) on some recently adopted opinions on hair dyes, Prof. Andersen said that the Working Party started to prepare a reply. Only the questions concerning mutagenicity remain and will be discussed during the next WP meeting.
Draft opinions on :
* A15 m-Aminophenol SCCNFP/0231/99
* A19 2,7-Naphthalenediol SCCNFP/0232/99
* A99 2,6-Dihydroxy-3,4-dimethylpyridine SCCNFP/0229/99
* B51 4-Amino-3-nitrophenol SCCNFP/0234/99
* B55 2-Amino-3-nitrophenol SCCNFP/0235/99
These 5 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 A19, should carry a label warning of a risk of sensitisation.
In the margin of the discussion, Prof. Andersen mentioned that opinions are now adopted on most of the hair dyes for which a safety file was received. For a series of hair dyes, additional data has been requested from industry. According to Dr Norgaard, the representative from DG ENTR, industry is using about 350 hair dyes and safety files were submitted on 140 of them.
If the Commission would be required to introduce a positive list on hair dyes, this would involve an additional submission from industry of about 210 safety files to be evaluated by the SCCNFP within a relative short time.
An alternative to the positive list would be the inclusion in Annex III to the cosmetics directive of those hair dyes on which the SCCNFP has adopted an opinion.
Dr. Norgaard said his service is considering both possibilities and might start discussion with the Member States later this year.
6.3 Inventory
Report of the Co-ordinator
Prof. Parra said that, since the draft 1st update of the inventory was received mid-December 1999, two Working Party meetings were organised to verify to which extent the various modifications discussed and agreed upon between the SCCNFP and COLIPA, have been incorporated.
As a result of these WP meetings, a working document, doc. n° SCCNFP/301/00, on the revision of the European Cosmetic Inventory was prepared and tabled for formal adoption by the Committee. The paper contains all the information to be incorporated and modifications to be made to the 1st and/or future updates.
The document was adopted by the SCCNFP and will serve as the basis for discussion with COLIPA during the next WP meeting of 23.3.2000. It is the aim of the Committee to conclude their work on the issue and to formally adopt an opinion concerning the 1st update during its plenary meeting of 28 June 2000.
6.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White reminded the plenary briefly about the mandate received concerning the safety of perfumery materials. He said that the Committee had decided to split this mandate into two parts, namely (i) the identification of those fragrance ingredients which are of concern as allergens for the consumer, (part a - chemically identified substances; part b - natural compounds containing unknown allergens) and (ii) opinions on the adoption of industry prohibited substances into Annex II and of industry restricted substances into Annex III of the Cosmetics Directive 76/768/EEC. An opinion on the first part (a) of the mandate was adopted during the 10th plenary meeting of 8.12.1999. In the frame of part one (b) of the mandate, the safety of oak moss and of tree moss will be reviewed.
Prior to initiating the second phase on the ‘Annex II' and ‘Annex III'-substances, the Working Party firstly considered the 'quenching phenomenon'. The Co-ordinator prepared a position paper on the issue which was tabled for formal adoption. A position on quenching is important as the inclusion of some chemicals in either Annex II or Annex III might depend on it.
Finally, he said that the work on the polycyclic musk is in its final stage and that draft opinions will be presented soon.
Draft position paper on the phenomenon of quenching, doc. n° SCCNFP/0294/00
The paper examines the evidence both for and against quenching, with particular relevance to the current understanding of the chemistry and biology of allergic contact dermatitis (ACD). It provides a reminder of the original observations and reviews the 3 points at which quenching might operate, namely at the chemical level, during the induction of skin sensitisation or during the elicitation of ACD.
The paper states that the existence of quenching of certain fragrance allergens by other specific fragrance compounds should be regarded as a hypothesis only.
The document was adopted by the SCCNFP.
Draft opinion on the safety of tattoos, doc. n° SCCNFP/0296/00
The recitals of the original Directive 76/768/EEC demonstrate that tattoos do not fall under the Cosmetics Directive. Although it would therefore not be appropriate to review the safety of tattoos within their remit on cosmetic products, the SCCNFP was requested to review the safety of tattoos as the issue may fall under their competence in their responsibility for non-food products. Moreover, the tattooing technique can be and is used for ‘permanent cosmetic decoration' e.g. on eye brows, for lip liner.
In response to this request, a draft opinion was prepared which considers two main items, namely the dyes used and the hygiene aspects (e.g. instruments used, transmission of infective agents). The document states that the substances used in these dyes are difficult to identify as they are very often marketed under fantasy names. However, for an adequate assessment of their toxicology, it is necessary to know the chemical identity of these colours and pigments.
The paper recommends that the identity of these substances - a provisional list is annexed - and materials (e.g., tools and appliances) used in the procedure be obtained so that a formal assessment can take place.
The document was adopted by the SCCNFP.
6.5 UV Filters
Report of the Co-ordinator
Dr. O'Mahony reported on the work done since the previous plenary meeting. He said that the requested information on Titanium dioxide was received and that it is at present being evaluated by the rapporteur.
The Working Party discussed as well two draft opinions on Titanium dioxide with a very specific coating. Additional data has been asked from industry.
S74, Benzylidene malonate polysiloxane : further to a discussion during a meeting of the Committee on Adaptation to Technical Progress concerning the draft 24th Commission Directive on the adaptation to technical progress of the Annexes to the Cosmetics Directive, some Members States raised several points on which they required additional information from the SCCNFP. These questions were discussed by the Working Party and a reply to the CAPT was prepared.
Dr. O'Mahony said that the questions asked were not of such a nature that the issue be discussed by the plenary meeting and requiring a formal adaptation. The members agreed with this procedure.
7. Report of the Chairman
* Working Party on Detergents : as decided during previous meeting, the Committee has set up a Working Party on detergents and similar household products. Since the consultation of the SCCNFP on safety aspects in relation with these consumer products is at present not mandatory, the committee will act according to Article 2.4 of Commission Decision 97/579/EC setting up the SC's. The article states that "the Scientific Committees may draw the Commission's attention to any specific or emerging problem falling within their remit in matters of consumer health and food safety.".
The members of the WP are : Prof. P. Elsner, Prof. V. Kapoulas, Prof. F. Kemper, Prof. N. Loprieno, Prof. J. Parra, Prof. V. Rogiers, Prof. T. Sanner, Prof. J. Vives Rego and Dr. I. White.
A meeting of the WP will be organised before next plenary meeting.
* Classification of substances : As the present classification system of substances proved to be unsatisfactory, a revised system was adopted. The main difference with the actual system is that a classification '3' is added. Classification 3 means : substance under consideration/evaluation but already in use and on the market for an extended period may remain under special provisions but only for a limited time which is recommended by the SCCNFP depending on the content of the safety data submitted.
* 7th Amendment : the representative of DG ENTR briefly informed the committee about the state of the file. He said that the draft is still in inter-service consultation and therefore not available. In its present form, it only deals with the animal testing issue.
* Resignation Prof. Blain (UK) : Prof. Kemper informed the committee about a letter the Commission received from Prof. Peter Blain sending in his resignation as a member of the SCCNFP.
8. Any Other Business
* Skin sensitisation testing, methodological considerations (ECETOC TR n° 78) : Copies were distributed for information. Prof. Kemper mentioned that an ECETOC Task Force is presently working on a monograph on skin sensitisation. The methodological considerations will be addressed in the first part of the paper, potency and risk assessment in the second part.
* Training course on safety assessment of cosmetics in the EU : Prof. Rogiers, who is organising the course in Brussels from 10 to 15 April 2000, briefly presented its main objectives.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr R. Glomot, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr D. O'Mahony, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mrs L. Benali DG SANCO, Mrs S. Clarke DG SANCO, Mrs M. de Solà DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mr A. Van Elst DG SANCO
Guest speaker : Mr A. Ruiz de Valbuena Council of Europe
Apologies : Mr P. Blain
Annex 1
Scientific Committee on Cosmetic and Non-Food Products - Agenda for the 11th plenary meeting (Brussels, 17 February 2000)
1. Adoption of the agenda SCCNFP/0283/99
2. Presentation of the activities of the Committee of Experts on Cosmetic Products of the Council of Europe
Dr. Angel Ruiz de Valbuena Paredes
3. Presentation of the 'Future of Scientific Advice in the EU' and of the ‘White Paper on Food Safety'
4. Declaration of interest
5. Approval of the minutes of the 10th plenary meeting of 8.12.99 SCCNFP/0265/99
6. SCCNFP - Specific Working Parties
6.1 Alternatives
Report of the Co-ordinator
Draft opinion on :
* SCCNFP basic requirements for testing cosmetic ingredients SCCNFP/0308/00 for their safety evaluation
* The predictive testing of potentially cutaneous sensitising
cosmetic ingredients or mixtures of ingredients SCCNFP/0120/99
6.2 Hair Dyes
Report of the Co-ordinator
Draft opinions on :
* A15 m-Aminophenol SCCNFP/0231/99
* A19 2,7-Naphthalenediol SCCNFP/0232/99
* A99 2,6-Dihydroxy-3,4-dimethylpyridine SCCNFP/0229/99
* B51 4-Amino-3-nitrophenol SCCNFP/0234/99
* B55 2-Amino-3-nitrophenol SCCNFP/0235/99
6.3 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft position paper on the phenomenon of quenching SCCNFP/0294/00
Draft opinion on the safety of tattoos SCCNFP/0296/00
6.4 Inventory
Report of the Co-ordinator
Working document concerning the revision of the European Cosmetic
Inventory SCCNFP/301/00
6.5 UV Filters
Report of the Co-ordinator
7. Report of the Chairman
* Classification of substances SCCNFP/0297/00
8. Any other business
* Skin sensitisation testing : methodological considerations (ECETOC Technical Report n° 78) - distribution of the document for information
