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Directorate-General for Health and Food Safety
Prof. Kemper, the chairman of the SCCNFP,
welcomed all participants.
1. Adoption of the Agenda (doc. n° SCCNFP/0366/00) (Annex)
The agenda was adopted.
2. Declaration of interest
None of the Members declared an interest that could prevent her/him from participating in the discussion of any of the items on the agenda.
3. Approval of the minutes of the 12th plenary meeting of 3 May 2000,
doc. n° SCCNFP/0349/00
The minutes were adopted, together with special thanks to the secretariat.
4. Renewal of the Scientific Committees
Elucidation was given by the Commission on the renewal of the scientific committees.
As mentioned in the call for expression of interest, published in the Official Journal of 20 May 2000 (OJ n° C142), a selection board comprising representatives from the Commission's consumer health and scientific research departments will be set up. It will be chaired by a member of the also renewed SSC.
This board will assess each expression of interest individually and will identify the most suitable scientific experts. These experts will be included in the list of experts for the SC's of the European Commission. The work of the panel will start early September 2000.
From among the candidates on this list, the Commission will appoint the members of the SC's, taking into account the need to ensure balance in particular in terms of the scientific disciplines required and geographical areas represented. At the same time, the Commission will apply a policy of equality between men and women.
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno said that the Working Party initiated the revision of Annex 5 and 7, according to what was decided during the previous plenary meeting of 3.5.2000, namely not to adopt a new version of the Notes of Guidance until the issues regarding these annexes were solved.
Exposure data : in response to a request from the Committee, Industry submitted information on consumer exposure to cosmetics. Exposure data are crucial for the revision of Annex 5.
The document received presents the results of a 1987 survey, which was the basis of exposure data given by industry in 1993 and 1997. It concludes that the data introduced by the SCCNFP in the present Annex 5 are still valid.
The Committee however said that this document only gives an overview of the use of cosmetic products in the various Member States but it do not answer their request for scientifically based specific and technical information on exposure.
Guidance for SME's : DG ENTR submitted to the Committee a copy of their draft "Guidance for SME's on the safety evaluation of cosmetic products without the use of animal testing". It appeared that, starting from a rudimentary document, a series of additions have been made in such a way that this ‘Guidance' could by-pass the SCCNFP Notes of Guidance, especially as the document is directly addressed to the cosmetic industry.
Therefore, the Committee, despite in general does not see a necessity for such a paper, strongly recommended that clear reference should be made in the document to the SCCNFP Notes of Guidance. In order to avoid misinterpretation by industry, the merit and reference of the SCCNFP's Notes of Guidance should be clearly stated.
The comments made by Prof. Loprieno on DG ENTR ‘Guidance for SME's' were adopted by the plenary (doc. n° SCCNFP/0364/00).
A joint meeting of the Committee, DG SANCO and DG ENTR is planned on 7 September 2000 to discuss the issue, and in particular the status of each of these documents.
5.2 Detergents
Report of the Co-ordinator
In his report, Prof. Vives Rego said that on 8 May 2000 the very first meeting of this recently set up Working Party took place during which he was asked to act as the co-ordinator. He reminded the meeting that the WP was set up further to a concern about possible health effects related to the use of detergents or other household cleaning products. The issue was raised by members of the SCCNFP and could be dealt with under the ‘Non-Food'-competence of the SCCNFP.
He said that during this first WP meeting, the European legal framework on detergents was presented and possible objectives were discussed. A further meeting is planned on 11 July 2000, during which a representative of DG ENTR will be invited in order to discuss the mandate for the committee.
5.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that the WP evaluated a further 10 draft opinions on hair dyes. For 9 of them, additional data are requested from industry. The discussion will resume upon receipt of this data. One draft opinion was approved and tabled today for adoption.
Draft opinion on A121 – Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) HCl, doc n° SCCNFP/0340/00
A121 is intended to be used in oxidative hair dye formulation at a maximum concentration of 3.0%. In combination with hydrogen peroxide (1:1), the in-use concentration is maximum 1.5%.
The opinion was adopted with a classification 1 (may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in the opinion) subject to the labelling of cosmetic products containing this substance warning of a risk of sensitisation.
Draft opinion concerning Amino Acids obtained by Hydrolysis of Human Hair, doc n° SCCNFP/0281/00
As mentioned during the previous plenary meeting of 3.5.2000, a copy of the dossier was sent to the Scientific Steering Committee (SSC) for critical comments as the issue is of a multidisciplinary nature. During its meeting of 25-26 May 2000, the SSC adopted an opinion on the safety of amino acids from human hair hydrolysates with regard to TSE risks. The SSC concluded that the risk resulting from the use of human hair preparations to provide amino acids for incorporation into human hair- and skin-care products would appear to be negligible.
Based on the opinion of the SSC and on the safety file submitted by industry, the committee concluded that amino acids obtained by hydrolysis of human hair can be considered safe as long as they are not contaminated with risk material.
The opinion was adopted by the SCCNFP.
Draft reply of the SCCNFP to Dr. A. Zilbersack, Austrian Delegation to the CATP
Elucidation was 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.
The draft reply prepared by the Working Party was adopted by the Committee. An official letter from the Commission will be sent to Dr. Zilbersack in this respect.
5.4 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that the Working Party concluded their work on the first update of Section I of the inventory. A draft opinion in this respect was tabled for formal adoption.
Draft opinion on the 1st update of Section I of the inventory, doc. n° SCCNFP/0299/00
Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on cosmetic products provides that the Commission shall compile an inventory of ingredients employed in cosmetic products on the basis in particular of information supplied by the industry concerned. The inventory shall be indicative and shall not constitute a list of substances authorised for use in cosmetic products.
Article 1 (4)(3) of Directive 93/35/EEC specifies that the inventory must be periodically updated.
Article 8 (2) of Directive 76/768/EEC specifies that the Scientific Committee on Cosmetology, now the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), shall be consulted.
In order to fulfil this task, the SCCNFP met experts from the European Industry and worked in collaboration with the Joint Research Centre of the European Commission.
Document n° SCCNFP/0299/00 was adopted by the SCCNFP which represents its opinion concerning the 1st update of Section I of the inventory. Nearly 10 000 improvements to the original version of section I were made. However, as the inventory is an evolving document, the SCCNFP proposes already in its opinion a series of approaches as recommendations for future updates.
The SCCNFP especially acknowledged the co-operation with COLIPA and its scientific experts in establishing the 1st update of section I of the inventory.
Concerning section II – Perfume and aromatic raw materials - of the inventory, the SCCNFP adopted during the 4th plenary meeting of 23 September 1999 a "position paper" concerning the revision of section II of the inventory and common nomenclature. This position paper is subject to further discussion and a draft opinion on the 1st update is prepared by the committee.
A copy of the draft will be sent to the fragrance industry, represented by EFFA, for comments. A discussion on this matter is planned with representatives of the fragrance industry on 5 September 2000.
5.5 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White introduced briefly the draft opinions tabled for adoption :
Draft opinion on bi-distillated refined coal tar, doc n° SCCNFP/0330/00
Crude and refined coal tar are at present listed in Annex II – list of substances which should not form part of the composition of cosmetic products.
Industry submitted a dossier on highly refined coal tar for use in rinse-off hair care products (anti-dandruff shampoos) and requested the SCCNFP if this bi-distillated refined coal tar, containing maximum 0.1 ppm of benzo(a) pyrene and low specified concentrations of some other polycyclic aromatic hydrocarbons, could be safely used for the proposed purpose and at the proposed concentration.
Only the genotoxicity and carcinogenicity have been considered.
It was said that, although bi-distillated refined coal tar did not show genotoxic effects in the mutagenicity tests, probably due to the lower concentrations of genotoxic substances in this highly refined coal tar compared to classic coal tars, it still contains genotoxic substances. As no thresholds are likely to be present for genotoxic carcinogens, each exposure is expected to represent a small but definite risk of cancer.
Based on these findings, the Committee was of the opinion not to remove bi-distillated refined coal tar from Annex II.
The opinion was adopted by the SCCNFP. Classification : 2A.
Draft position paper on the safety of alpha-Hydroxy acids, doc. n° SCCNFP/0370/00
The Committee was asked to review the safety of α-Hydroxy acids (AHA's) in cosmetics with respect to their dermal tolerance. Glycolic acid and lactic acid are the most commonly used AHA's in cosmetics.
A main concern of the committee is the maintenance of the barrier function integrity of the skin including effects on possible enhanced absorption of other substances/cosmetic ingredients and effects of AHA's on the skin's responses to UV light.
As a result, the committee stated that as there is a lack of data, studies should be performed on :
* the evaluation of safety of long term use,
* the investigation of the maintenance of the barrier function integrity, including effects of percutaneous absorption,
* the effects of AHA's on the skin's responses to UV exposure.
Therefore, and until the required data are available, the committee would suggest the following :
- glycolic acid may be safely used at a level up to 4% and a pH ≥ 3.8,
- lactic acid at a level up to 2.5% and a pH ≥ 5, and
- appropriate warnings to the consumer to avoid contact with the eyes and UV exposure.
Because of the lack of information, the Committee asked the Commission to put the position paper on the internet and to invite interested parties to comment.
The Position Paper was adopted by the SCCNFP.
Draft opinion on AHTN, doc. n° SCCNFP/0372/00, revision 2 of 14.6.2000
A draft opinion was tabled.
However, as there were different points of view concerning the dose related effects seen in the sub-chronic toxicity and teratogenicity studies and consequently on the NOEL used in the calculation of the Margin of Safety, it was decided to re-evaluate these study reports and to report on the findings during the next WP meeting of 5 and 6 September 2000.
5.6 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the safety assessment of Titanium dioxide, coated/uncoated, for use as an UV filter is still on-going. A meeting took place on 13 June 2000 with industry experts during which all open questions were discussed.
The understanding of the members of the WP about the answers received during this meeting was stated in a letter to be sent to COLIPA, as the representative of the cosmetic industry. A draft of this letter was tabled for comments.
Upon receipt of industry's reply, the Working Party will be in a position to come to a conclusion and to present a draft opinion to the plenary meeting for formal adoption.
6. Report of the Chairman
* Harmonisation of risk assessment : Prof. Kemper said that the final version of this document was adopted by the SSC during its meeting of 25-26 May 2000.
Prof. Kemper said that the purpose of the paper is to identify the procedures to improve the efficiency of risk assessments and peer reviews and to maximise the utility of the findings. He said that, to improve the effectiveness and to strengthen the motivation of the scientific committees, it is important to keep the committees informed of the follow-up taken in the areas in which they conducted risk assessments/peer reviews and of the usefulness in the risk management process. To achieve these goals, a dialogue is essential throughout the process between the scientific committees and the Commission services concerned.
* Salicylic acid : further to an opinion adopted on the ‘+'-marked preservatives, a safety file was received on salicylic acid. The file aims to demonstrate the safety of salicylic acid when used for other specific purposes - other than ‘preservative' purposes - apparent from the presentation of the product and in concentrations other than those laid down in Annex VI of the cosmetics directive.
* Cotton woven fabrics : Prof. Kemper said that the SCCNFP might be asked to consider whether there are reasons to believe that the use of woven fabrics made from cotton treated with specific pesticides may provoke adverse health effects.
7. Any Other Business
* Further plenary meetings : 24 October 2000, and for the constitution of the renewed SCCNFP : 27 November 2000
Attendance List
Present : Mr K.E. Andersen Mr N. Loprieno, Mr R. Anton Mr J. Parra, Mr J-F. Doré Mr D. O'Mahony, Mr P. Elsner Mrs V. Rogiers, Mr R. Glomot Mr T. Sanner, Mr V. Kapoulas, Mr J. Vives Rego, Mr F. Kemper Mr I. White, Mr B. Lina
External experts : Mr Ph. Masson Mrs R. Schumann
Commission : Mrs L. Benali DG SANCO, Mrs M. de Solà DG SANCO, Mrs S. Clarke DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs A. Szklanna DG SANCO, Mr A. Van Elst DG SANCO
Annex - Agenda for the 13th plenary meeting (Brussels, 28 June 2000)
1. Adoption of the agenda
2. Declaration of interest
3. Approval of the minutes of the 12th plenary meeting of 3.5.00
4. Renewal of the Scientific Committees : information by the Commission services
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
Comments on DG ENTR document ‘Guidance for SME's on the safety evaluation of cosmetic products without the use of animal testing,
5.2 Detergents
Report of the Co-ordinator
5.3 Hair Dyes
Report of the Co-ordinator
Draft opinion on A121
Amino acids obtained by hydrolysis of human hair
Draft reply of the SCCNFP to Dr. Zilbersack, Austrian delegation to the CATP
5.4 Inventory
Report of the Co-ordinator
Draft opinion on the 1st update of section I of the inventory and common nomenclature of ingredients employed in cosmetic products
5.5 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on bi-distillated refined coal tar, doc. n° SCCNFP/0330/00
Draft position paper on AHA's
Draft opinion on AHTN
5.6 UV Filters
Report of the Co-ordinator
6. Report of the Chairman
Harmonisation of risk assessment
7. Any other business
* Harmonisation of risk assessment
* submission on salicylic acid
* Woven fabrics from cotton treated with pesticides
* future meetings
1. Adoption of the Agenda (doc. n° SCCNFP/0366/00) (Annex)
The agenda was adopted.
2. Declaration of interest
None of the Members declared an interest that could prevent her/him from participating in the discussion of any of the items on the agenda.
3. Approval of the minutes of the 12th plenary meeting of 3 May 2000,
doc. n° SCCNFP/0349/00
The minutes were adopted, together with special thanks to the secretariat.
4. Renewal of the Scientific Committees
Elucidation was given by the Commission on the renewal of the scientific committees.
As mentioned in the call for expression of interest, published in the Official Journal of 20 May 2000 (OJ n° C142), a selection board comprising representatives from the Commission's consumer health and scientific research departments will be set up. It will be chaired by a member of the also renewed SSC.
This board will assess each expression of interest individually and will identify the most suitable scientific experts. These experts will be included in the list of experts for the SC's of the European Commission. The work of the panel will start early September 2000.
From among the candidates on this list, the Commission will appoint the members of the SC's, taking into account the need to ensure balance in particular in terms of the scientific disciplines required and geographical areas represented. At the same time, the Commission will apply a policy of equality between men and women.
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno said that the Working Party initiated the revision of Annex 5 and 7, according to what was decided during the previous plenary meeting of 3.5.2000, namely not to adopt a new version of the Notes of Guidance until the issues regarding these annexes were solved.
Exposure data : in response to a request from the Committee, Industry submitted information on consumer exposure to cosmetics. Exposure data are crucial for the revision of Annex 5.
The document received presents the results of a 1987 survey, which was the basis of exposure data given by industry in 1993 and 1997. It concludes that the data introduced by the SCCNFP in the present Annex 5 are still valid.
The Committee however said that this document only gives an overview of the use of cosmetic products in the various Member States but it do not answer their request for scientifically based specific and technical information on exposure.
Guidance for SME's : DG ENTR submitted to the Committee a copy of their draft "Guidance for SME's on the safety evaluation of cosmetic products without the use of animal testing". It appeared that, starting from a rudimentary document, a series of additions have been made in such a way that this ‘Guidance' could by-pass the SCCNFP Notes of Guidance, especially as the document is directly addressed to the cosmetic industry.
Therefore, the Committee, despite in general does not see a necessity for such a paper, strongly recommended that clear reference should be made in the document to the SCCNFP Notes of Guidance. In order to avoid misinterpretation by industry, the merit and reference of the SCCNFP's Notes of Guidance should be clearly stated.
The comments made by Prof. Loprieno on DG ENTR ‘Guidance for SME's' were adopted by the plenary (doc. n° SCCNFP/0364/00).
A joint meeting of the Committee, DG SANCO and DG ENTR is planned on 7 September 2000 to discuss the issue, and in particular the status of each of these documents.
5.2 Detergents
Report of the Co-ordinator
In his report, Prof. Vives Rego said that on 8 May 2000 the very first meeting of this recently set up Working Party took place during which he was asked to act as the co-ordinator. He reminded the meeting that the WP was set up further to a concern about possible health effects related to the use of detergents or other household cleaning products. The issue was raised by members of the SCCNFP and could be dealt with under the ‘Non-Food'-competence of the SCCNFP.
He said that during this first WP meeting, the European legal framework on detergents was presented and possible objectives were discussed. A further meeting is planned on 11 July 2000, during which a representative of DG ENTR will be invited in order to discuss the mandate for the committee.
5.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that the WP evaluated a further 10 draft opinions on hair dyes. For 9 of them, additional data are requested from industry. The discussion will resume upon receipt of this data. One draft opinion was approved and tabled today for adoption.
Draft opinion on A121 – Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) HCl, doc n° SCCNFP/0340/00
A121 is intended to be used in oxidative hair dye formulation at a maximum concentration of 3.0%. In combination with hydrogen peroxide (1:1), the in-use concentration is maximum 1.5%.
The opinion was adopted with a classification 1 (may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in the opinion) subject to the labelling of cosmetic products containing this substance warning of a risk of sensitisation.
Draft opinion concerning Amino Acids obtained by Hydrolysis of Human Hair, doc n° SCCNFP/0281/00
As mentioned during the previous plenary meeting of 3.5.2000, a copy of the dossier was sent to the Scientific Steering Committee (SSC) for critical comments as the issue is of a multidisciplinary nature. During its meeting of 25-26 May 2000, the SSC adopted an opinion on the safety of amino acids from human hair hydrolysates with regard to TSE risks. The SSC concluded that the risk resulting from the use of human hair preparations to provide amino acids for incorporation into human hair- and skin-care products would appear to be negligible.
Based on the opinion of the SSC and on the safety file submitted by industry, the committee concluded that amino acids obtained by hydrolysis of human hair can be considered safe as long as they are not contaminated with risk material.
The opinion was adopted by the SCCNFP.
Draft reply of the SCCNFP to Dr. A. Zilbersack, Austrian Delegation to the CATP
Elucidation was 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.
The draft reply prepared by the Working Party was adopted by the Committee. An official letter from the Commission will be sent to Dr. Zilbersack in this respect.
5.4 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that the Working Party concluded their work on the first update of Section I of the inventory. A draft opinion in this respect was tabled for formal adoption.
Draft opinion on the 1st update of Section I of the inventory, doc. n° SCCNFP/0299/00
Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on cosmetic products provides that the Commission shall compile an inventory of ingredients employed in cosmetic products on the basis in particular of information supplied by the industry concerned. The inventory shall be indicative and shall not constitute a list of substances authorised for use in cosmetic products.
Article 1 (4)(3) of Directive 93/35/EEC specifies that the inventory must be periodically updated.
Article 8 (2) of Directive 76/768/EEC specifies that the Scientific Committee on Cosmetology, now the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), shall be consulted.
In order to fulfil this task, the SCCNFP met experts from the European Industry and worked in collaboration with the Joint Research Centre of the European Commission.
Document n° SCCNFP/0299/00 was adopted by the SCCNFP which represents its opinion concerning the 1st update of Section I of the inventory. Nearly 10 000 improvements to the original version of section I were made. However, as the inventory is an evolving document, the SCCNFP proposes already in its opinion a series of approaches as recommendations for future updates.
The SCCNFP especially acknowledged the co-operation with COLIPA and its scientific experts in establishing the 1st update of section I of the inventory.
Concerning section II – Perfume and aromatic raw materials - of the inventory, the SCCNFP adopted during the 4th plenary meeting of 23 September 1999 a "position paper" concerning the revision of section II of the inventory and common nomenclature. This position paper is subject to further discussion and a draft opinion on the 1st update is prepared by the committee.
A copy of the draft will be sent to the fragrance industry, represented by EFFA, for comments. A discussion on this matter is planned with representatives of the fragrance industry on 5 September 2000.
5.5 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White introduced briefly the draft opinions tabled for adoption :
Draft opinion on bi-distillated refined coal tar, doc n° SCCNFP/0330/00
Crude and refined coal tar are at present listed in Annex II – list of substances which should not form part of the composition of cosmetic products.
Industry submitted a dossier on highly refined coal tar for use in rinse-off hair care products (anti-dandruff shampoos) and requested the SCCNFP if this bi-distillated refined coal tar, containing maximum 0.1 ppm of benzo(a) pyrene and low specified concentrations of some other polycyclic aromatic hydrocarbons, could be safely used for the proposed purpose and at the proposed concentration.
Only the genotoxicity and carcinogenicity have been considered.
It was said that, although bi-distillated refined coal tar did not show genotoxic effects in the mutagenicity tests, probably due to the lower concentrations of genotoxic substances in this highly refined coal tar compared to classic coal tars, it still contains genotoxic substances. As no thresholds are likely to be present for genotoxic carcinogens, each exposure is expected to represent a small but definite risk of cancer.
Based on these findings, the Committee was of the opinion not to remove bi-distillated refined coal tar from Annex II.
The opinion was adopted by the SCCNFP. Classification : 2A.
Draft position paper on the safety of alpha-Hydroxy acids, doc. n° SCCNFP/0370/00
The Committee was asked to review the safety of α-Hydroxy acids (AHA's) in cosmetics with respect to their dermal tolerance. Glycolic acid and lactic acid are the most commonly used AHA's in cosmetics.
A main concern of the committee is the maintenance of the barrier function integrity of the skin including effects on possible enhanced absorption of other substances/cosmetic ingredients and effects of AHA's on the skin's responses to UV light.
As a result, the committee stated that as there is a lack of data, studies should be performed on :
* the evaluation of safety of long term use,
* the investigation of the maintenance of the barrier function integrity, including effects of percutaneous absorption,
* the effects of AHA's on the skin's responses to UV exposure.
Therefore, and until the required data are available, the committee would suggest the following :
- glycolic acid may be safely used at a level up to 4% and a pH ≥ 3.8,
- lactic acid at a level up to 2.5% and a pH ≥ 5, and
- appropriate warnings to the consumer to avoid contact with the eyes and UV exposure.
Because of the lack of information, the Committee asked the Commission to put the position paper on the internet and to invite interested parties to comment.
The Position Paper was adopted by the SCCNFP.
Draft opinion on AHTN, doc. n° SCCNFP/0372/00, revision 2 of 14.6.2000
A draft opinion was tabled.
However, as there were different points of view concerning the dose related effects seen in the sub-chronic toxicity and teratogenicity studies and consequently on the NOEL used in the calculation of the Margin of Safety, it was decided to re-evaluate these study reports and to report on the findings during the next WP meeting of 5 and 6 September 2000.
5.6 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the safety assessment of Titanium dioxide, coated/uncoated, for use as an UV filter is still on-going. A meeting took place on 13 June 2000 with industry experts during which all open questions were discussed.
The understanding of the members of the WP about the answers received during this meeting was stated in a letter to be sent to COLIPA, as the representative of the cosmetic industry. A draft of this letter was tabled for comments.
Upon receipt of industry's reply, the Working Party will be in a position to come to a conclusion and to present a draft opinion to the plenary meeting for formal adoption.
6. Report of the Chairman
* Harmonisation of risk assessment : Prof. Kemper said that the final version of this document was adopted by the SSC during its meeting of 25-26 May 2000.
Prof. Kemper said that the purpose of the paper is to identify the procedures to improve the efficiency of risk assessments and peer reviews and to maximise the utility of the findings. He said that, to improve the effectiveness and to strengthen the motivation of the scientific committees, it is important to keep the committees informed of the follow-up taken in the areas in which they conducted risk assessments/peer reviews and of the usefulness in the risk management process. To achieve these goals, a dialogue is essential throughout the process between the scientific committees and the Commission services concerned.
* Salicylic acid : further to an opinion adopted on the ‘+'-marked preservatives, a safety file was received on salicylic acid. The file aims to demonstrate the safety of salicylic acid when used for other specific purposes - other than ‘preservative' purposes - apparent from the presentation of the product and in concentrations other than those laid down in Annex VI of the cosmetics directive.
* Cotton woven fabrics : Prof. Kemper said that the SCCNFP might be asked to consider whether there are reasons to believe that the use of woven fabrics made from cotton treated with specific pesticides may provoke adverse health effects.
7. Any Other Business
* Further plenary meetings : 24 October 2000, and for the constitution of the renewed SCCNFP : 27 November 2000
Attendance List
Present : Mr K.E. Andersen Mr N. Loprieno, Mr R. Anton Mr J. Parra, Mr J-F. Doré Mr D. O'Mahony, Mr P. Elsner Mrs V. Rogiers, Mr R. Glomot Mr T. Sanner, Mr V. Kapoulas, Mr J. Vives Rego, Mr F. Kemper Mr I. White, Mr B. Lina
External experts : Mr Ph. Masson Mrs R. Schumann
Commission : Mrs L. Benali DG SANCO, Mrs M. de Solà DG SANCO, Mrs S. Clarke DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs A. Szklanna DG SANCO, Mr A. Van Elst DG SANCO
Annex - Agenda for the 13th plenary meeting (Brussels, 28 June 2000)
1. Adoption of the agenda
2. Declaration of interest
3. Approval of the minutes of the 12th plenary meeting of 3.5.00
4. Renewal of the Scientific Committees : information by the Commission services
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
Comments on DG ENTR document ‘Guidance for SME's on the safety evaluation of cosmetic products without the use of animal testing,
5.2 Detergents
Report of the Co-ordinator
5.3 Hair Dyes
Report of the Co-ordinator
Draft opinion on A121
Amino acids obtained by hydrolysis of human hair
Draft reply of the SCCNFP to Dr. Zilbersack, Austrian delegation to the CATP
5.4 Inventory
Report of the Co-ordinator
Draft opinion on the 1st update of section I of the inventory and common nomenclature of ingredients employed in cosmetic products
5.5 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on bi-distillated refined coal tar, doc. n° SCCNFP/0330/00
Draft position paper on AHA's
Draft opinion on AHTN
5.6 UV Filters
Report of the Co-ordinator
6. Report of the Chairman
Harmonisation of risk assessment
7. Any other business
* Harmonisation of risk assessment
* submission on salicylic acid
* Woven fabrics from cotton treated with pesticides
* future meetings
