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Directorate-General for Health and Food Safety
0. Reorganisation of the Commission
services
The Chairman, Prof. Kemper informed the committee about the decisions taken during the first formal meeting of the new Commission in order to implement the changes to the structure of the Commission services announced by the President of the Commission, Romano Prodi, in July.
He mentioned that Mr. Reichenbach has been appointed Director General of the Personnel and Administration Directorate-General and Mr. Coleman as Director General of the Health and Consumer Protection as from 1st October 1999.
Prof. Kemper said he does not see any change in the near future in relation to the working of the Scientific Committees.
1. Adoption of the Agenda (doc. n° SCCNFP/0216/99) (Annex 1)
The agenda was adopted subject to the insertion of a report on work going on in DG III concerning guidance for SME in relation to alternative/in-vitro methods.
2. Approval of the minutes of the 8th plenary meeting of 23 June 1999
doc. n° SCCNFP/0204/99
The minutes were adopted subject to the following remarks :
* Alternative methods : to the question on how one could ensure that the alternative methods adopted by the SCCNFP, are effectively used and inserted in the safety dossier, the co-ordinator, Prof. Loprieno, replied that it is up to the SCCNFP to require that these alternative methods are used for its designed toxicological end-point and no longer the traditional in-vivo studies.
* Updating Notes of Guidance : to the question why there was no trace in the minutes concerning the revision of Annex 5 -Margin of Safety of Preservatives of the Notes of Guidance, the co-ordinator replied that new data on the exposure to preservatives were received from COLIPA. The data will be evaluated and the Annex might be adapted accordingly.
* Ketoconazole : it was stated to mention expressively in the minutes that the SCCNFP required a follow-up to this opinion, namely also other scientific committees (e.g. the SC on Toxicology, Eco-toxicology and Environment, the SC on Veterinary Measures relating to Public Health, the SC on Medicinal Products and Medical Devices) should consider this chemical because of its use in other sectors and because of its possible ecological effects. The Chairman said he will write a letter to the chairman of the Scientific Steering Committee requesting the insertion of this point in the agenda of the next SSC meeting.
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
In his report of the co-ordinator, Prof. Loprieno, presented the on-going work, and in particular :
* the elaboration of new annexes on the physical, chemical and microbiological specifications of cosmetic products. To this end, ISO and the Council of Europe will be addressed in relation to methods, limits and specifications for cosmetic products.
* some kind of guidance would be welcomed on the way to behave in relation to alternative methods found in the scientific literature or developed by other bodies e.g. ICCVAM in the USA. As an example, it was discussed whether the SCCNFP can adopt an opinion on the applicability to cosmetics products of a particular alternative method not yet validated by ECVAM/ESAC, e.g. the Murine Local Lymph Node Assay, a test method for assessing the allergic contact dermatitis potential of chemicals/compounds.
* eye irritation : the Working Party will resume their work on the issue once the data from industry are received.
3.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said he could be very brief as no meetings were held since the plenary meeting of 23.6.99.
Two further Working Party meetings were scheduled to finalise the draft opinions on the priority files identified earlier.
3.3 Inventory
Report of the Co-ordinator
In his report, the co-ordinator, Prof. Parra, said that all the issues raised during the last years in relation to the 1st update of the inventory and common nomenclature have been discussed with and accepted by the parties concerned, namely COLIPA and the Working Party 'Inventory' of the SCCNFP.
In view of an urgent publication, a time table for the edition of this 1st update was proposed and approved, which should lead to an official adoption of the 1st update by the SCCNFP within the next 4 months.
On the question whether it was possible to publish the document on the internet immediately after its adoption by the SCCNFP, the representative of DG III said that it was legally not possible. All community languages must be available prior to its official publication. However, it could be put on the web as an working document adopted by the SCCNFP. It was agreed to proceed this way.
3.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
Dr. White reported on the pending issues, and in particular on the safety assessment of Methyleugenol, the Alpha-Hydroxy-Acids and the polycyclic musk's.
Draft opinions were prepared and presented on :
Acrylamide residues in cosmetic, doc. n° SCCNFP/011/98
Acrylamide polymers are used in some cosmetic products due to their ability to function in many different ways. Polyacrylamides contain traces of unreacted acrylamide.
Acrylamide is a genotoxic carcinogen and because of residual acrylamide in polyacrylamide preparations, lifelong use of cosmetic products containing polyacrylamide may represent an unacceptable high lifetime risk of cancer.
In order that a lifetime use of cosmetics containing polyacrylamide should not pose a significant cancer risk, the SCCNFP was of the opinion that the theoretical content of residual acrylamide [calculated from the amount of polyacrylamide added to the product and the content of acrylamide in the polyacrylamide used] should be <0.1 ppm in body care leave-on products and <0.5 ppm in other cosmetic products.
This opinion was adopted by the plenary.
Nitro Musk's - Musk Ketone, doc. n° SCCNFP/0162/99, revision 4
- Musk Xylene, doc. n° SCCNFP/0163/99, revision 4
Dr. White introduced the issue and said that, although there are different routes of exposure and therefore the overall exposure to these chemicals should be assessed, the Working Party stated that these draft opinions answer only the questions asked to the SCCNFP (mandate), namely the risk associated to the presence of musk's in cosmetic formulations.
He also mentioned that the documents tabled were slightly different from the one's approved by the Working Party on 20-21.9.99. The modification were marked with arrows or were in italics.
The rapporteur(s) presented the document and said that the safety assessments were made based on the data presently available on Musk Ketone and Xylene respectively. The subsequent discussion focussed mainly of the proposed maximum concentration of 1.5% of these musk's in the fragrance compounds used in cosmetic products. However, as the percentage of fragrance compound in cosmetic products might be easily changed, the proposal was not seen as the right way to restrict the use of these musk's.
There was concern about carcinogenicity, which is uncertain, and on the accumulation in mother's milk, which is uncertain as well. These concerns should be clearly specified in the opinions especially since the Margin of Safety is high.
Moreover, the sensitisation data were considered to be unsatisfactory, especially as Musk Xylene is a potential sensitiser.
As a result, the co-ordinator invited all members to go through the document and to respond, by e-mail, within 2 weeks with any question regarding information they would like to see or any points for clarification they would like to raise.
These comments will be sent to the rapporteurs for consideration/inclusion in the draft opinion and subsequent discussion in the next Working Party meeting.
The representative of DG III stipulated that the committee should propose a maximum concentration in the finished product. The directive regulates finished cosmetic products, not its constituents, which is in this particular case the fragrance compound.
Draft Pre-opinion concerning fragrance allergy in consumers, doc. n° SCCNFP/0017/98
Further to the adoption during the 8th Plenary meeting of 23.6.99 of an interim position on fragrance allergens, the WP prepared a draft pre-opinion as a review of the problem of fragrance allergy in consumers due to the presence of fragrance compounds in cosmetic products.
The document is an analysis of the need for appropriate consumer information and an identification of consumer allergens.
It had been agreed that the draft pre-opinion should be placed onto the internet with an invitation for comments. These comments were to be assessed by the rapporteur and chairman before being presented to the next WP. A final draft of the document would then be presented to the Plenary for formal adoption as an opinion of the SCCNFP.
The plenary meeting approved the document and requested the Commission to put it on the internet and to invite interested parties for their comments before 2 November 1999.
3.5 UV Filters
Report of the Co-ordinator
Although no further Working Party meetings have taken place since the previous plenary meeting of 23.6.99, the co-ordinator, Dr Lina reported on the state of the pending issues :
* S75 : Coated Titanium dioxide : a letter was sent in July 99 requiring industry to respond specifically to the questions asked. Industry replied they will respond to each of the questions asked as soon as possible. Work will resume upon receipt of the data.
* S16 : 4-Isopropylbenzyl salicylate : further to a mandate from DG III concerning its use as a UV-absorber in order to protect cosmetic products, a letter was sent to industry requesting additional data. Also for this issue, work will resume upon receipt of the data.
The representative of DG III mentioned that a joint interagency group (Commission + FDA) will be set up to consider UVA and high SPF claims as well as to align on SPF methodology. This work would certainly involve the SCCNFP.
4. Report of the Chairman
In his report the Chairman, Prof. Kemper reported on :
* + marked preservatives (Annex VI) : industry replied saying they are identifying those preservatives for which there is a current interest for other uses than those laid down in Annex VI and that they have initiated a survey among its members on the substances concerned.
* quenching phenomena : it was proposed to invite Dr. D. Basketter for the next plenary meeting of 8 December 1999 for a presentation on the issue.
* Council of Europe : the Commission forwarded to the members of the SCCNFP in August 99 the working documents received from the Council of Europe Committee of Experts on Cosmetic Products. The Chairman said that contacts between the Commission and the Council of Europe have been established in order to align their priority/policies so that duplication of work could be avoided.
* Potential modification to entry 416 of Annex II : the committee was mandated to evaluate the risk of amino acids from human hair hydrolysates with regard to the transmission of Creutzfeldt Jakob Disease and viral diseases. The file was addressed to the WP 'Hair Dyes' for evaluation.
* Updating of the 5FP Quality of Life Working Programme : the point was mentioned for information only. Researches are still invited to submit proposals on research needs expressed in the opinions of the committee.
5. Any Other Business
* Guidance for SME's in relation to in-vitro methods : upon initiative of DG III, meetings were organised with interested parties (Commission services, representatives of industry) to draft guidance for SME's concerning alternative methods. The matter was raised in order to clarify the position of the SCCNFP in this respect.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Mrs J.D. Johansen external expert, Mr Ph. Masson external expert, Mr D. O'Mahony external expert, Mrs R. Schumann external expert
Commission : Mr L. Bansil DG III, Mrs L. Benali DG XXIV, Mrs S. Clarke DG XXIV, Mr J. Crespo-Arce DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV Mr G. Fracchia DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mr P. Elsner
Annex 1 - Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 9th plenary meeting (Brussels, 30 September 1999)
1. Adoption of the agenda - SCCNFP/0216/99
2. Approval of the minutes of the 8th plenary meeting of 23.6.99 - SCCNFP/0204/99
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
Notes of Guidance :
* Elaboration of new annexes on Physical, Chemical and Microbiological Specifications of Cosmetic Products - SCCNFP/0208/99
* COLIPA Comments on Annex 7 - microbiological quality of the finished cosmetic product - SCCNFP/0175/99
3.2 Hair Dyes
Report of the Co-ordinator
* Work programme on pending files
3.3 Inventory
Report of the Co-ordinator
* Position paper : Time table for the edition of the first update of the cosmetics inventory - SCCNFP/0217/99
3.4 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
* Draft opinion on Acrylamide - SCCNFP/0011/98
* Draft opinion on Musk Ketone - SCCNFP/0163/99
* Draft opinion on Musk Xylene - SCCNFP/0162/99
* Fragrance Allergens - SCCNFP/0017/98
3.5 UV Filters
Report of the Co-ordinator
4. Report of the Chairman
* COLIPA submission on Cells, tissues or products of human origin. Amino acids from human hair hydrolysate.
* Updating of the 5th FP Quality of Life Working programme, request for proposals
* Council of Europe, Committee of Experts on Cosmetic Products
5. Any other business
* Report on guidance for SME's in relation to in vitro methods
The Chairman, Prof. Kemper informed the committee about the decisions taken during the first formal meeting of the new Commission in order to implement the changes to the structure of the Commission services announced by the President of the Commission, Romano Prodi, in July.
He mentioned that Mr. Reichenbach has been appointed Director General of the Personnel and Administration Directorate-General and Mr. Coleman as Director General of the Health and Consumer Protection as from 1st October 1999.
Prof. Kemper said he does not see any change in the near future in relation to the working of the Scientific Committees.
1. Adoption of the Agenda (doc. n° SCCNFP/0216/99) (Annex 1)
The agenda was adopted subject to the insertion of a report on work going on in DG III concerning guidance for SME in relation to alternative/in-vitro methods.
2. Approval of the minutes of the 8th plenary meeting of 23 June 1999
doc. n° SCCNFP/0204/99
The minutes were adopted subject to the following remarks :
* Alternative methods : to the question on how one could ensure that the alternative methods adopted by the SCCNFP, are effectively used and inserted in the safety dossier, the co-ordinator, Prof. Loprieno, replied that it is up to the SCCNFP to require that these alternative methods are used for its designed toxicological end-point and no longer the traditional in-vivo studies.
* Updating Notes of Guidance : to the question why there was no trace in the minutes concerning the revision of Annex 5 -Margin of Safety of Preservatives of the Notes of Guidance, the co-ordinator replied that new data on the exposure to preservatives were received from COLIPA. The data will be evaluated and the Annex might be adapted accordingly.
* Ketoconazole : it was stated to mention expressively in the minutes that the SCCNFP required a follow-up to this opinion, namely also other scientific committees (e.g. the SC on Toxicology, Eco-toxicology and Environment, the SC on Veterinary Measures relating to Public Health, the SC on Medicinal Products and Medical Devices) should consider this chemical because of its use in other sectors and because of its possible ecological effects. The Chairman said he will write a letter to the chairman of the Scientific Steering Committee requesting the insertion of this point in the agenda of the next SSC meeting.
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
In his report of the co-ordinator, Prof. Loprieno, presented the on-going work, and in particular :
* the elaboration of new annexes on the physical, chemical and microbiological specifications of cosmetic products. To this end, ISO and the Council of Europe will be addressed in relation to methods, limits and specifications for cosmetic products.
* some kind of guidance would be welcomed on the way to behave in relation to alternative methods found in the scientific literature or developed by other bodies e.g. ICCVAM in the USA. As an example, it was discussed whether the SCCNFP can adopt an opinion on the applicability to cosmetics products of a particular alternative method not yet validated by ECVAM/ESAC, e.g. the Murine Local Lymph Node Assay, a test method for assessing the allergic contact dermatitis potential of chemicals/compounds.
* eye irritation : the Working Party will resume their work on the issue once the data from industry are received.
3.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said he could be very brief as no meetings were held since the plenary meeting of 23.6.99.
Two further Working Party meetings were scheduled to finalise the draft opinions on the priority files identified earlier.
3.3 Inventory
Report of the Co-ordinator
In his report, the co-ordinator, Prof. Parra, said that all the issues raised during the last years in relation to the 1st update of the inventory and common nomenclature have been discussed with and accepted by the parties concerned, namely COLIPA and the Working Party 'Inventory' of the SCCNFP.
In view of an urgent publication, a time table for the edition of this 1st update was proposed and approved, which should lead to an official adoption of the 1st update by the SCCNFP within the next 4 months.
On the question whether it was possible to publish the document on the internet immediately after its adoption by the SCCNFP, the representative of DG III said that it was legally not possible. All community languages must be available prior to its official publication. However, it could be put on the web as an working document adopted by the SCCNFP. It was agreed to proceed this way.
3.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
Dr. White reported on the pending issues, and in particular on the safety assessment of Methyleugenol, the Alpha-Hydroxy-Acids and the polycyclic musk's.
Draft opinions were prepared and presented on :
Acrylamide residues in cosmetic, doc. n° SCCNFP/011/98
Acrylamide polymers are used in some cosmetic products due to their ability to function in many different ways. Polyacrylamides contain traces of unreacted acrylamide.
Acrylamide is a genotoxic carcinogen and because of residual acrylamide in polyacrylamide preparations, lifelong use of cosmetic products containing polyacrylamide may represent an unacceptable high lifetime risk of cancer.
In order that a lifetime use of cosmetics containing polyacrylamide should not pose a significant cancer risk, the SCCNFP was of the opinion that the theoretical content of residual acrylamide [calculated from the amount of polyacrylamide added to the product and the content of acrylamide in the polyacrylamide used] should be <0.1 ppm in body care leave-on products and <0.5 ppm in other cosmetic products.
This opinion was adopted by the plenary.
Nitro Musk's - Musk Ketone, doc. n° SCCNFP/0162/99, revision 4
- Musk Xylene, doc. n° SCCNFP/0163/99, revision 4
Dr. White introduced the issue and said that, although there are different routes of exposure and therefore the overall exposure to these chemicals should be assessed, the Working Party stated that these draft opinions answer only the questions asked to the SCCNFP (mandate), namely the risk associated to the presence of musk's in cosmetic formulations.
He also mentioned that the documents tabled were slightly different from the one's approved by the Working Party on 20-21.9.99. The modification were marked with arrows or were in italics.
The rapporteur(s) presented the document and said that the safety assessments were made based on the data presently available on Musk Ketone and Xylene respectively. The subsequent discussion focussed mainly of the proposed maximum concentration of 1.5% of these musk's in the fragrance compounds used in cosmetic products. However, as the percentage of fragrance compound in cosmetic products might be easily changed, the proposal was not seen as the right way to restrict the use of these musk's.
There was concern about carcinogenicity, which is uncertain, and on the accumulation in mother's milk, which is uncertain as well. These concerns should be clearly specified in the opinions especially since the Margin of Safety is high.
Moreover, the sensitisation data were considered to be unsatisfactory, especially as Musk Xylene is a potential sensitiser.
As a result, the co-ordinator invited all members to go through the document and to respond, by e-mail, within 2 weeks with any question regarding information they would like to see or any points for clarification they would like to raise.
These comments will be sent to the rapporteurs for consideration/inclusion in the draft opinion and subsequent discussion in the next Working Party meeting.
The representative of DG III stipulated that the committee should propose a maximum concentration in the finished product. The directive regulates finished cosmetic products, not its constituents, which is in this particular case the fragrance compound.
Draft Pre-opinion concerning fragrance allergy in consumers, doc. n° SCCNFP/0017/98
Further to the adoption during the 8th Plenary meeting of 23.6.99 of an interim position on fragrance allergens, the WP prepared a draft pre-opinion as a review of the problem of fragrance allergy in consumers due to the presence of fragrance compounds in cosmetic products.
The document is an analysis of the need for appropriate consumer information and an identification of consumer allergens.
It had been agreed that the draft pre-opinion should be placed onto the internet with an invitation for comments. These comments were to be assessed by the rapporteur and chairman before being presented to the next WP. A final draft of the document would then be presented to the Plenary for formal adoption as an opinion of the SCCNFP.
The plenary meeting approved the document and requested the Commission to put it on the internet and to invite interested parties for their comments before 2 November 1999.
3.5 UV Filters
Report of the Co-ordinator
Although no further Working Party meetings have taken place since the previous plenary meeting of 23.6.99, the co-ordinator, Dr Lina reported on the state of the pending issues :
* S75 : Coated Titanium dioxide : a letter was sent in July 99 requiring industry to respond specifically to the questions asked. Industry replied they will respond to each of the questions asked as soon as possible. Work will resume upon receipt of the data.
* S16 : 4-Isopropylbenzyl salicylate : further to a mandate from DG III concerning its use as a UV-absorber in order to protect cosmetic products, a letter was sent to industry requesting additional data. Also for this issue, work will resume upon receipt of the data.
The representative of DG III mentioned that a joint interagency group (Commission + FDA) will be set up to consider UVA and high SPF claims as well as to align on SPF methodology. This work would certainly involve the SCCNFP.
4. Report of the Chairman
In his report the Chairman, Prof. Kemper reported on :
* + marked preservatives (Annex VI) : industry replied saying they are identifying those preservatives for which there is a current interest for other uses than those laid down in Annex VI and that they have initiated a survey among its members on the substances concerned.
* quenching phenomena : it was proposed to invite Dr. D. Basketter for the next plenary meeting of 8 December 1999 for a presentation on the issue.
* Council of Europe : the Commission forwarded to the members of the SCCNFP in August 99 the working documents received from the Council of Europe Committee of Experts on Cosmetic Products. The Chairman said that contacts between the Commission and the Council of Europe have been established in order to align their priority/policies so that duplication of work could be avoided.
* Potential modification to entry 416 of Annex II : the committee was mandated to evaluate the risk of amino acids from human hair hydrolysates with regard to the transmission of Creutzfeldt Jakob Disease and viral diseases. The file was addressed to the WP 'Hair Dyes' for evaluation.
* Updating of the 5FP Quality of Life Working Programme : the point was mentioned for information only. Researches are still invited to submit proposals on research needs expressed in the opinions of the committee.
5. Any Other Business
* Guidance for SME's in relation to in-vitro methods : upon initiative of DG III, meetings were organised with interested parties (Commission services, representatives of industry) to draft guidance for SME's concerning alternative methods. The matter was raised in order to clarify the position of the SCCNFP in this respect.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Mrs J.D. Johansen external expert, Mr Ph. Masson external expert, Mr D. O'Mahony external expert, Mrs R. Schumann external expert
Commission : Mr L. Bansil DG III, Mrs L. Benali DG XXIV, Mrs S. Clarke DG XXIV, Mr J. Crespo-Arce DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV Mr G. Fracchia DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mr P. Elsner
Annex 1 - Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 9th plenary meeting (Brussels, 30 September 1999)
1. Adoption of the agenda - SCCNFP/0216/99
2. Approval of the minutes of the 8th plenary meeting of 23.6.99 - SCCNFP/0204/99
3. SCCNFP - Specific Working Parties
3.1 Alternatives
Report of the Co-ordinator
Notes of Guidance :
* Elaboration of new annexes on Physical, Chemical and Microbiological Specifications of Cosmetic Products - SCCNFP/0208/99
* COLIPA Comments on Annex 7 - microbiological quality of the finished cosmetic product - SCCNFP/0175/99
3.2 Hair Dyes
Report of the Co-ordinator
* Work programme on pending files
3.3 Inventory
Report of the Co-ordinator
* Position paper : Time table for the edition of the first update of the cosmetics inventory - SCCNFP/0217/99
3.4 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
* Draft opinion on Acrylamide - SCCNFP/0011/98
* Draft opinion on Musk Ketone - SCCNFP/0163/99
* Draft opinion on Musk Xylene - SCCNFP/0162/99
* Fragrance Allergens - SCCNFP/0017/98
3.5 UV Filters
Report of the Co-ordinator
4. Report of the Chairman
* COLIPA submission on Cells, tissues or products of human origin. Amino acids from human hair hydrolysate.
* Updating of the 5th FP Quality of Life Working programme, request for proposals
* Council of Europe, Committee of Experts on Cosmetic Products
5. Any other business
* Report on guidance for SME's in relation to in vitro methods
