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Directorate-General for Health and Food Safety
1. 20th Anniversary of the
establishment of the Scientific
Committee on Cosmetology
The Chairman, Prof. Kemper said he had the pleasure to announce the 20th anniversary of the Scientific Committee on Cosmetology. The committee, which was set up by Commission Decision n° 78/45/EEC of 19 December 1977, met for the first time on 19 September 1978 during which Prof. F.A. Fairweather was elected as its first chairman. Since, the chair was successively taken by Prof. L. Gatti (†) from 1982 to 1984, by Dr. R. Goulding from 1984 to 1987, by Prof. N. Loprieno from 1987 to 1993 and by Prof. F. Kemper since 1993.
He recalled that the committee was established to assist the Commission in any problem of a scientific or technical nature in the field of cosmetic products and thanked all the present and former members for their contribution to this task for the benefit of the consumer.
2. Adoption of the Agenda (annex 1)
The agenda was adopted.
3. Approval of the minutes of the 3rd plenary meeting of 20 May 1998
The minutes were adopted subject to the following modification :
* point 5.1 Alternatives to Animal Testing & Dossier : the secretariat was asked to annex to the minutes the full report in the written form as provided by the co-ordinator.
4. SCCNFP - Specific Working Parties
4.1 Alternatives to Animal Testing & Dossier
In his report, the co-ordinator commented on the discussions held since the 3rd plenary meeting of 20 May 1998. He mentioned that the WP met 2 times and that the work was concentrated (i) on the revision of Annex VII (Microbiological Quality of the Finished Cosmetic Product) of the Notes of Guidance and (ii) on the Use of Human Volunteers in the safety evaluation of cosmetic ingredients. The results of these discussions are crystallised in two documents which were presented to the meeting.
The co-ordinator reminded the meeting of the time pressure the SCCNFP, and in particular the WP 'Alternatives' is facing. The Committee engaged itself to present to the Commission by the end of January 1999 the state of the art in an opinion on the use of alternative methods for the safety assessment of cosmetic ingredients. To conclude on this work, 2 further WP meetings are planned still this year as well as, if necessary, an extra-ordinary plenary meeting early next year.
(i) Revision of Annex VII - Microbiological Quality of the Finished Cosmetic Product
(doc. n° SCCNFP/0004/98)
The revision of Annex VII is essentially a technical one, which was partly the result of internal discussions and partly the result of an exchange of information and discussions with other interested parties. The rapporteur presented and illustrated the improvements made to the original version.
The document was subsequently adopted by the plenary meeting without further comments or modifications.
The secretariat was asked to make the necessary changes to the Notes of Guidance, namely to replace the present version of Annex VII by the newly adopted one and to transfer this to the Internet edition.
(ii) Human testing (doc. n° SCCNFP/0003/98)
The latest version, as approved by the WP, was tabled. This document focuses mainly on the irritation potential of ingredients or mixtures of ingredients. A further document on the irritancy of finished products is under preparation.
The document outlines the statement of the SCCNFP regarding the use of human volunteers in relation to alternative test methods. It was however stressed that these guidelines on the potential use of human volunteers may not be seen as an alternative to animal testing.
As a result, it was decided not to adopt the document at present but to re-address it to the Working Party concerned for further refining, and in particular concerning the issue of repeated irritancy testing.
In the context of this issue, a brief introduction and information was given by Prof. Ph. Masson on the difficulties of the report he is preparing at the request of the SCCNFP on the various laws and regulations in force in the Member States of the European Union concerning ethical procedures for cosmetic products and their ingredients when intended to be investigated on human beings.
4.2 Hair Dyes
In his report, the co-ordinator mentioned that there have been no WP meeting on hair dyes since the 3rd plenary meeting. However, the following topics were dealt with :
The foreseeable use of hair dyes
It has come recently to the attention of DG III that the translation of 'hair' into the official EU languages has led to serious consequences in the transposition of the various technical adaptations of the cosmetics directive.
In languages, such as French or Spanish, hair has been translated and transposed at national level as relating only to the hair on the head. The SCCNFP was asked whether its opinions on the safety of hair dyes relate to the use of such materials on the head only or on all bodily hair.
As a result of the discussion, the SCCNFP has adopted the opinion that 'hair', with reference to hair dyes within Directive 76/768/EEC on cosmetic products, relates to all bodily hair unless otherwise indicated through a specific warning and or labelling.
Pending dossiers
Since its establishment, the scientific committee reviewed industry submissions on hair dyes and evaluated their safety. However, in the light of a discussion about the possible establishment of a positive list on hair dyes in the cosmetics directive, the secretariat prepared a 'state of the art' on hair dyes.
Starting from this 'state of the art', which gives, beside details on the finalised and pending files, an estimation of the number of files to be expected in the coming years, the Committee discussed a way which offers an approach on feasibility and efficacy with this considerable amount of work. The SCCNFP asked the WP to discuss matters under these premises and to establish a proposal to be presented at one of the next meetings.
Hydroquinone
The Chairman referred back to the previous plenary meeting of 20 May 1998, where it was concluded that the use of hydroquinone as a hair dye constituent needed further investigation, and in particular that the NOAEL data should be re-evaluated and the margin of safety re-established.
A further safety dossier on the use of hydroquinone in hair dye formulation was received shortly before this plenary meeting. Based on this document, the rapporteur prepared a revised draft opinion, which he tabled.
As a result, two separate opinions, one on hydroquinone as a skin lightener, for which a classification 2a was approved, and one as a hair dye constituent will exist in the future.
4.3 Inventory
In his report, the Co-ordinator said that the Working Party has now discussed and concluded on most of the modifications to be made to the present version of the inventory. One further meeting with COLIPA is planned during which the 'new entries' will be discussed.
In the context of the continuing efforts of the WP to resolve nomenclature problems in the current inventory, the following two documents on nomenclature of ingredients were adopted as position papers of the SCCNFP :
* Report on the nomenclature of ingredients of botanical origin - doc n° XXIV/182/98
Aspects of the lack of transparency present in the current inventory (both sections) were presented. These had been corrected in the proposed new 'product-specific' nomenclature (one entry for each ingredient derived from different parts of the same plant, or by different processings etc).
The document was adopted as a position paper of the SCCNFP.
* Report on Section II of the inventory - doc. n° SCCNFP/0022/98
It had been mentioned many times that that Section II of the Inventory in its present form is unsuitable for its intended role as a tool of transparency and to enable the Commission to assess issues relating to the use of cosmetics.
Discussions with the fragrance industry had indicated that they would be unwilling to assist in improving Section II and that it lacked practical purpose. Despite the fact that the Cosmetics Directive makes the statement 'the inventory shall be compiled by the Commission on the basis of information supplied by the industry concerned', membership of the SCCNFP had revised the whole of Section II. This extensive revision has resulted in a document where the terms are chemically correct, alphabetically listed, common names are included, errors have been removed, cross reference is made to those substances also present in Section I and note is made to those substances subject to a restriction. The preamble to Section II had also been rewritten appropriately.
The plenary adopted the document as a SCCNFP position paper suitable for release by DG XXIV to DG III or for publication.
He mentioned as well that the 1st update of the inventory, as prepared by COLIPA and based on the results of the discussions held so far, is expected to be available by 15 October 1998.
This draft 1st update will be presented to the Committee for its opinion. A meeting with the Committee, DG III, DG XXIV and COLIPA is to be organised to seek a common consensus of what the first update should include. It is expected that a final document will be available within 4 to 5 months.
4.4 Preservatives, Colorants & Fragrances
In his report, the Co-ordinator mentioned the issues dealt with since the last plenary meeting :
* Draft opinion on Acrylamide - doc. n° SCCNFP/0011/98 : further safety data were received from industry on acrylamide since the issue was discussed in the WP. The rapporteur is at present evaluating these data and a revised draft opinion is to be discussed during the next WP meeting on 3 November 1998.
* Draft opinion on Carbamide peroxide - doc. n° SCCNFP/0058/98 : also on this substance, a request for an opinion was received. The safety data are at present under evaluation and a draft opinion will be tabled and discussed during next WP meeting of 3.11.98.
* Fragrances : on 23 June 1998, a delegation from EFFA gave a presentation of their industry and on the methodologies they use as part of the safety assessment of fragrance ingredients.
At the same time, a document on fragrance allergy was produced but it will be extended and discussed at the next WP meeting. In this framework, a letter will be sent to EFFA requesting to provide the safety data they used to assess the cutaneous safety of substances which IFRA recommends should have a restricted function. DG III mentioned they are prepared to discuss the inclusion of the IFRA 'not to be used' and 'restricted' substances in Annex II and III of the cosmetics directive, respectively.
* Draft opinion on P21 - Benzylhemiformal - doc. n° SCCNFP/0033/98 : for technical and administrative reasons, the adoption of the opinion on this substance had to be postponed until the next plenary meeting.
Opinion on boric acid, borates and tetraborates - doc. n° SCCNFP/0025/98
At the 21st meeting of the CATP, the Commission had withdrawn its proposal concerning boric acid, borates and tetraborates from the draft of 21st Commission Directive. Further to the request of the delegations of the Member States, the Commission referred the issue to the Scientific Committee, which was asked to put forward scientific proposals for avoiding the resorption of free boric acid. In addition, the Cosmetic Industry presented a further skin penetration study, which was discussed in the WP and based on which the present draft opinion prepared.
As a result of the discussion, the following modifications were made to the existing draft :
* column e : replace under a) and c) the sentence 'Not to be used on damaged/unhealthy skin' by 'Not to be used on damaged/unhealthy skin, if the free soluble borate level exceeds 1,5% (expressed as boric acid)';
* column e : delete the 'b)'.
The opinion was subsequently adopted by the plenary meeting.
Opinion on Strontium Nitrate, lactate and polycarboxylate - doc. n° SCCNFP/0044/98
These three substances were put previously in Annex II by the 15th Commission Directive on adaptation to technical progress of the cosmetics directive. During the 2nd Plenary meeting of 21 January 1998, the Committee adopted opinions on the 13 so called 'Angelopharm' substances, confirming their inclusion in Annex II.
However, on the 3 strontium compounds, the Committee adopted a provisional opinion saying that, as far as it is known the strontium cation is not toxic by itself and that compounds of strontium for use in cosmetics should be considered on a case by case basis.
Consequently, Strontium lactate, Strontium nitrate and Strontium polycarboxylate were further discussed by the WP and a draft opinion prepared saying that the three mentioned Strontium compounds should be withdrawn from Annex II of the Cosmetic Directive as there is at present no toxicological profile known which could substantiate an evaluation by the SCCNFP.
This draft was discussed by the plenary and subsequently adopted as an opinion.
4.5 UV Filters
The Co-ordinator reported on what has been discussed in the Working Party since the previous plenary meeting. 8 dossiers are presently under considerations, 4 of which consist of additional questions asked to the applicants.
* Expert panel workshop : as reported earlier, the Committee envisages to organise an expert panel workshop to address issues such as the use of sunscreen formulations or other sun protection measures and their relation to malignant or other (skin)diseases and/or to address health risks in general in relation to exposure to the sun.
A remit has been prepared for this panel, which covers the following points :
- to advise on safety implications of the use of UV sunscreens and UV protection;
- to examine the biological consequences of this type of ingredients;
- to assess the potential use of sunscreens and UV filters to alter the behaviour/exposure to the different types of UV, specifically in adults and children;
- to review the suitability of the present SPF for consumer information.
The expert panel would probably meet in spring or early summer 1999 if the budgetary premises can be solved.
5. Report of the Chairman
* New format for the opinions of the SCCNFP : with reference to the discussion on the subject in previous meetings, the secretariat prepared a draft of the new format for the opinions of the SCCNFP. The Chairman illustrated the rationale behind the document and said that it was in line with what has been said during the previous meeting.
The plenary concluded that this new format should be used from now on for new applications.
* Rules of procedure - doc. n° SCCNFP/0042/98 : a final draft was prepared and presented to the Committee. As this document was already discussed in the previous plenary meetings, the Committee adopted the documents without further comments.
6. Questions raised by DG III
* Specific evaluation for children : during a previous meeting of the Committee on Adaptation to Technical Progress, a question was asked whether the SCCNFP takes account of the particular body weight of children while calculating the margin of safety for a specific ingredient.
The plenary meeting stated that there is clear evidence that the SCCNFP takes special note of the safety concerns related to children. A statement which was underlined by the numerous references made to in its opinions as 'Not to be used for children under three/twelve years of age', Keep out of reach of children', 'Keep powder away from children's nose and mouth' or ' frequent use by children is not advisable'.
For future opinions, it was proposed to note in a special keyword possible influences in children.
* Definition of Hair Dyes : this item has been dealt with under point 4.2 Hair dyes.
* Tattoo's : the Committee was asked to provide some guidelines on the safety precautions and on the nature of the pigments to be used. Tattooing is seen by the Committee as a surgical procedure with a not negligible risk of disease transfer. It can be considered as a special kind of an intentionally permanent make-up where colours are brought into the upper layers of the skin. The WP 'Preservatives, Colorants and Fragrances' was asked to take this issue on board and to prepare, if possible, a draft paper on it.
* Tallow derivatives : the wording of the SCC opinion of 24.6.97 on tallow derivatives was slightly revised and adapted to bring it in line with the opinions adopted by the other Scientific Committees on the issue. In its opinion, under the point 'transesterification/hydrolysis' the wording '40 bar' is replaced by the wording 'under pressure'.
7. Any Other Business
* Plenary meetings in 1999 - the following dates were fixed
20 January 1999
17 February 1999
23 June 1999
30 September 1999
8 December 1999
* Household products : the question was raised by the Co-ordinator of the WP 'Preservatives, Colorants & Fragrances' as to whether this Committee is the right forum to introduce issues on household products and their cutaneous safety. The Commission answered that, indeed, this is the case. Under normal practice, the opinion of a scientific committee is sought in the framework of a directive or any other piece of legislation. However, the legislation on detergents is on its way and a state of the art on the issue will be given during one of the next plenary meetings.
Attendance List
Present:
Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr C.J. Powell, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
External experts: Mr L. Celleno, Mrs J.D. Johansen, Mr D. O'Mahony, Mr Ph. Masson, Mr. L. Pons Gimier
Commission : Mr L. Bansil DG III, Mrs P. Decamps DG XXIV, Mr W. De Klerck DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer
ANNEX 1
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 4th plenary meeting
(Brussels, 23 September 1998)
1. 20th Anniversary of the establishment of the Scientific Committee on Cosmetology
2. Adoption of the agenda SCCNFP/0041/98
3. Approval of the minutes of the 3rd plenary meeting of 20.5.98 SCCNFP/0050/98
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Minutes of the meeting of 15-16.6.98 SCCNFP/0021/98
Oral report on meeting 22.9.98
Annex VII : Microbiological Quality of the finished cosmetic product - SCCNFP/0004/98
Guidelines on the use of human volunteers in the testing of potentially cutaneous irritant cosmetic ingredients SCCNFP/0003/98
4.2 Hair Dyes
Report of the Co-ordinator, including working programme
Hydroquinone XXIV/2002/97
4.3 Inventory
Report of the Co-ordinator
Report on botanicals XXIV/1828/98
Report on Section II of the inventory (Fragrances) SCCNFP/0022/98
4.4 Preservatives
Report of the Co-ordinator
Draft opinion on Benzylhemiformal (P21) SCCNFP/0033/98
Opinion on Boric acid, borates and tetraborates SCCNFP/0025/98
Opinion on Strontium lactate, nitrate and polycarboxylate SCCNFP/0044/98
4.5 UV Filters
Report of the Co-ordinator
Expert panel meeting "Sun Protection"
5. Report of the Chairman
Format and structure of the opinions of the Scientific Committees - SCCNFP/0000/98
Rules of Procedure of the SCCNFP SCCNFP/0042/98
6. Questions raised by DG III
Specific evaluation for children
Classification of substances
Definition of hair dyes type
Tattoos
7. Any other business
Planning plenary meetings in 1999
The Chairman, Prof. Kemper said he had the pleasure to announce the 20th anniversary of the Scientific Committee on Cosmetology. The committee, which was set up by Commission Decision n° 78/45/EEC of 19 December 1977, met for the first time on 19 September 1978 during which Prof. F.A. Fairweather was elected as its first chairman. Since, the chair was successively taken by Prof. L. Gatti (†) from 1982 to 1984, by Dr. R. Goulding from 1984 to 1987, by Prof. N. Loprieno from 1987 to 1993 and by Prof. F. Kemper since 1993.
He recalled that the committee was established to assist the Commission in any problem of a scientific or technical nature in the field of cosmetic products and thanked all the present and former members for their contribution to this task for the benefit of the consumer.
2. Adoption of the Agenda (annex 1)
The agenda was adopted.
3. Approval of the minutes of the 3rd plenary meeting of 20 May 1998
The minutes were adopted subject to the following modification :
* point 5.1 Alternatives to Animal Testing & Dossier : the secretariat was asked to annex to the minutes the full report in the written form as provided by the co-ordinator.
4. SCCNFP - Specific Working Parties
4.1 Alternatives to Animal Testing & Dossier
In his report, the co-ordinator commented on the discussions held since the 3rd plenary meeting of 20 May 1998. He mentioned that the WP met 2 times and that the work was concentrated (i) on the revision of Annex VII (Microbiological Quality of the Finished Cosmetic Product) of the Notes of Guidance and (ii) on the Use of Human Volunteers in the safety evaluation of cosmetic ingredients. The results of these discussions are crystallised in two documents which were presented to the meeting.
The co-ordinator reminded the meeting of the time pressure the SCCNFP, and in particular the WP 'Alternatives' is facing. The Committee engaged itself to present to the Commission by the end of January 1999 the state of the art in an opinion on the use of alternative methods for the safety assessment of cosmetic ingredients. To conclude on this work, 2 further WP meetings are planned still this year as well as, if necessary, an extra-ordinary plenary meeting early next year.
(i) Revision of Annex VII - Microbiological Quality of the Finished Cosmetic Product
(doc. n° SCCNFP/0004/98)
The revision of Annex VII is essentially a technical one, which was partly the result of internal discussions and partly the result of an exchange of information and discussions with other interested parties. The rapporteur presented and illustrated the improvements made to the original version.
The document was subsequently adopted by the plenary meeting without further comments or modifications.
The secretariat was asked to make the necessary changes to the Notes of Guidance, namely to replace the present version of Annex VII by the newly adopted one and to transfer this to the Internet edition.
(ii) Human testing (doc. n° SCCNFP/0003/98)
The latest version, as approved by the WP, was tabled. This document focuses mainly on the irritation potential of ingredients or mixtures of ingredients. A further document on the irritancy of finished products is under preparation.
The document outlines the statement of the SCCNFP regarding the use of human volunteers in relation to alternative test methods. It was however stressed that these guidelines on the potential use of human volunteers may not be seen as an alternative to animal testing.
As a result, it was decided not to adopt the document at present but to re-address it to the Working Party concerned for further refining, and in particular concerning the issue of repeated irritancy testing.
In the context of this issue, a brief introduction and information was given by Prof. Ph. Masson on the difficulties of the report he is preparing at the request of the SCCNFP on the various laws and regulations in force in the Member States of the European Union concerning ethical procedures for cosmetic products and their ingredients when intended to be investigated on human beings.
4.2 Hair Dyes
In his report, the co-ordinator mentioned that there have been no WP meeting on hair dyes since the 3rd plenary meeting. However, the following topics were dealt with :
The foreseeable use of hair dyes
It has come recently to the attention of DG III that the translation of 'hair' into the official EU languages has led to serious consequences in the transposition of the various technical adaptations of the cosmetics directive.
In languages, such as French or Spanish, hair has been translated and transposed at national level as relating only to the hair on the head. The SCCNFP was asked whether its opinions on the safety of hair dyes relate to the use of such materials on the head only or on all bodily hair.
As a result of the discussion, the SCCNFP has adopted the opinion that 'hair', with reference to hair dyes within Directive 76/768/EEC on cosmetic products, relates to all bodily hair unless otherwise indicated through a specific warning and or labelling.
Pending dossiers
Since its establishment, the scientific committee reviewed industry submissions on hair dyes and evaluated their safety. However, in the light of a discussion about the possible establishment of a positive list on hair dyes in the cosmetics directive, the secretariat prepared a 'state of the art' on hair dyes.
Starting from this 'state of the art', which gives, beside details on the finalised and pending files, an estimation of the number of files to be expected in the coming years, the Committee discussed a way which offers an approach on feasibility and efficacy with this considerable amount of work. The SCCNFP asked the WP to discuss matters under these premises and to establish a proposal to be presented at one of the next meetings.
Hydroquinone
The Chairman referred back to the previous plenary meeting of 20 May 1998, where it was concluded that the use of hydroquinone as a hair dye constituent needed further investigation, and in particular that the NOAEL data should be re-evaluated and the margin of safety re-established.
A further safety dossier on the use of hydroquinone in hair dye formulation was received shortly before this plenary meeting. Based on this document, the rapporteur prepared a revised draft opinion, which he tabled.
As a result, two separate opinions, one on hydroquinone as a skin lightener, for which a classification 2a was approved, and one as a hair dye constituent will exist in the future.
4.3 Inventory
In his report, the Co-ordinator said that the Working Party has now discussed and concluded on most of the modifications to be made to the present version of the inventory. One further meeting with COLIPA is planned during which the 'new entries' will be discussed.
In the context of the continuing efforts of the WP to resolve nomenclature problems in the current inventory, the following two documents on nomenclature of ingredients were adopted as position papers of the SCCNFP :
* Report on the nomenclature of ingredients of botanical origin - doc n° XXIV/182/98
Aspects of the lack of transparency present in the current inventory (both sections) were presented. These had been corrected in the proposed new 'product-specific' nomenclature (one entry for each ingredient derived from different parts of the same plant, or by different processings etc).
The document was adopted as a position paper of the SCCNFP.
* Report on Section II of the inventory - doc. n° SCCNFP/0022/98
It had been mentioned many times that that Section II of the Inventory in its present form is unsuitable for its intended role as a tool of transparency and to enable the Commission to assess issues relating to the use of cosmetics.
Discussions with the fragrance industry had indicated that they would be unwilling to assist in improving Section II and that it lacked practical purpose. Despite the fact that the Cosmetics Directive makes the statement 'the inventory shall be compiled by the Commission on the basis of information supplied by the industry concerned', membership of the SCCNFP had revised the whole of Section II. This extensive revision has resulted in a document where the terms are chemically correct, alphabetically listed, common names are included, errors have been removed, cross reference is made to those substances also present in Section I and note is made to those substances subject to a restriction. The preamble to Section II had also been rewritten appropriately.
The plenary adopted the document as a SCCNFP position paper suitable for release by DG XXIV to DG III or for publication.
He mentioned as well that the 1st update of the inventory, as prepared by COLIPA and based on the results of the discussions held so far, is expected to be available by 15 October 1998.
This draft 1st update will be presented to the Committee for its opinion. A meeting with the Committee, DG III, DG XXIV and COLIPA is to be organised to seek a common consensus of what the first update should include. It is expected that a final document will be available within 4 to 5 months.
4.4 Preservatives, Colorants & Fragrances
In his report, the Co-ordinator mentioned the issues dealt with since the last plenary meeting :
* Draft opinion on Acrylamide - doc. n° SCCNFP/0011/98 : further safety data were received from industry on acrylamide since the issue was discussed in the WP. The rapporteur is at present evaluating these data and a revised draft opinion is to be discussed during the next WP meeting on 3 November 1998.
* Draft opinion on Carbamide peroxide - doc. n° SCCNFP/0058/98 : also on this substance, a request for an opinion was received. The safety data are at present under evaluation and a draft opinion will be tabled and discussed during next WP meeting of 3.11.98.
* Fragrances : on 23 June 1998, a delegation from EFFA gave a presentation of their industry and on the methodologies they use as part of the safety assessment of fragrance ingredients.
At the same time, a document on fragrance allergy was produced but it will be extended and discussed at the next WP meeting. In this framework, a letter will be sent to EFFA requesting to provide the safety data they used to assess the cutaneous safety of substances which IFRA recommends should have a restricted function. DG III mentioned they are prepared to discuss the inclusion of the IFRA 'not to be used' and 'restricted' substances in Annex II and III of the cosmetics directive, respectively.
* Draft opinion on P21 - Benzylhemiformal - doc. n° SCCNFP/0033/98 : for technical and administrative reasons, the adoption of the opinion on this substance had to be postponed until the next plenary meeting.
Opinion on boric acid, borates and tetraborates - doc. n° SCCNFP/0025/98
At the 21st meeting of the CATP, the Commission had withdrawn its proposal concerning boric acid, borates and tetraborates from the draft of 21st Commission Directive. Further to the request of the delegations of the Member States, the Commission referred the issue to the Scientific Committee, which was asked to put forward scientific proposals for avoiding the resorption of free boric acid. In addition, the Cosmetic Industry presented a further skin penetration study, which was discussed in the WP and based on which the present draft opinion prepared.
As a result of the discussion, the following modifications were made to the existing draft :
* column e : replace under a) and c) the sentence 'Not to be used on damaged/unhealthy skin' by 'Not to be used on damaged/unhealthy skin, if the free soluble borate level exceeds 1,5% (expressed as boric acid)';
* column e : delete the 'b)'.
The opinion was subsequently adopted by the plenary meeting.
Opinion on Strontium Nitrate, lactate and polycarboxylate - doc. n° SCCNFP/0044/98
These three substances were put previously in Annex II by the 15th Commission Directive on adaptation to technical progress of the cosmetics directive. During the 2nd Plenary meeting of 21 January 1998, the Committee adopted opinions on the 13 so called 'Angelopharm' substances, confirming their inclusion in Annex II.
However, on the 3 strontium compounds, the Committee adopted a provisional opinion saying that, as far as it is known the strontium cation is not toxic by itself and that compounds of strontium for use in cosmetics should be considered on a case by case basis.
Consequently, Strontium lactate, Strontium nitrate and Strontium polycarboxylate were further discussed by the WP and a draft opinion prepared saying that the three mentioned Strontium compounds should be withdrawn from Annex II of the Cosmetic Directive as there is at present no toxicological profile known which could substantiate an evaluation by the SCCNFP.
This draft was discussed by the plenary and subsequently adopted as an opinion.
4.5 UV Filters
The Co-ordinator reported on what has been discussed in the Working Party since the previous plenary meeting. 8 dossiers are presently under considerations, 4 of which consist of additional questions asked to the applicants.
* Expert panel workshop : as reported earlier, the Committee envisages to organise an expert panel workshop to address issues such as the use of sunscreen formulations or other sun protection measures and their relation to malignant or other (skin)diseases and/or to address health risks in general in relation to exposure to the sun.
A remit has been prepared for this panel, which covers the following points :
- to advise on safety implications of the use of UV sunscreens and UV protection;
- to examine the biological consequences of this type of ingredients;
- to assess the potential use of sunscreens and UV filters to alter the behaviour/exposure to the different types of UV, specifically in adults and children;
- to review the suitability of the present SPF for consumer information.
The expert panel would probably meet in spring or early summer 1999 if the budgetary premises can be solved.
5. Report of the Chairman
* New format for the opinions of the SCCNFP : with reference to the discussion on the subject in previous meetings, the secretariat prepared a draft of the new format for the opinions of the SCCNFP. The Chairman illustrated the rationale behind the document and said that it was in line with what has been said during the previous meeting.
The plenary concluded that this new format should be used from now on for new applications.
* Rules of procedure - doc. n° SCCNFP/0042/98 : a final draft was prepared and presented to the Committee. As this document was already discussed in the previous plenary meetings, the Committee adopted the documents without further comments.
6. Questions raised by DG III
* Specific evaluation for children : during a previous meeting of the Committee on Adaptation to Technical Progress, a question was asked whether the SCCNFP takes account of the particular body weight of children while calculating the margin of safety for a specific ingredient.
The plenary meeting stated that there is clear evidence that the SCCNFP takes special note of the safety concerns related to children. A statement which was underlined by the numerous references made to in its opinions as 'Not to be used for children under three/twelve years of age', Keep out of reach of children', 'Keep powder away from children's nose and mouth' or ' frequent use by children is not advisable'.
For future opinions, it was proposed to note in a special keyword possible influences in children.
* Definition of Hair Dyes : this item has been dealt with under point 4.2 Hair dyes.
* Tattoo's : the Committee was asked to provide some guidelines on the safety precautions and on the nature of the pigments to be used. Tattooing is seen by the Committee as a surgical procedure with a not negligible risk of disease transfer. It can be considered as a special kind of an intentionally permanent make-up where colours are brought into the upper layers of the skin. The WP 'Preservatives, Colorants and Fragrances' was asked to take this issue on board and to prepare, if possible, a draft paper on it.
* Tallow derivatives : the wording of the SCC opinion of 24.6.97 on tallow derivatives was slightly revised and adapted to bring it in line with the opinions adopted by the other Scientific Committees on the issue. In its opinion, under the point 'transesterification/hydrolysis' the wording '40 bar' is replaced by the wording 'under pressure'.
7. Any Other Business
* Plenary meetings in 1999 - the following dates were fixed
20 January 1999
17 February 1999
23 June 1999
30 September 1999
8 December 1999
* Household products : the question was raised by the Co-ordinator of the WP 'Preservatives, Colorants & Fragrances' as to whether this Committee is the right forum to introduce issues on household products and their cutaneous safety. The Commission answered that, indeed, this is the case. Under normal practice, the opinion of a scientific committee is sought in the framework of a directive or any other piece of legislation. However, the legislation on detergents is on its way and a state of the art on the issue will be given during one of the next plenary meetings.
Attendance List
Present:
Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr C.J. Powell, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
External experts: Mr L. Celleno, Mrs J.D. Johansen, Mr D. O'Mahony, Mr Ph. Masson, Mr. L. Pons Gimier
Commission : Mr L. Bansil DG III, Mrs P. Decamps DG XXIV, Mr W. De Klerck DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr A. Van Elst DG XXIV
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer
ANNEX 1
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 4th plenary meeting
(Brussels, 23 September 1998)
1. 20th Anniversary of the establishment of the Scientific Committee on Cosmetology
2. Adoption of the agenda SCCNFP/0041/98
3. Approval of the minutes of the 3rd plenary meeting of 20.5.98 SCCNFP/0050/98
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Minutes of the meeting of 15-16.6.98 SCCNFP/0021/98
Oral report on meeting 22.9.98
Annex VII : Microbiological Quality of the finished cosmetic product - SCCNFP/0004/98
Guidelines on the use of human volunteers in the testing of potentially cutaneous irritant cosmetic ingredients SCCNFP/0003/98
4.2 Hair Dyes
Report of the Co-ordinator, including working programme
Hydroquinone XXIV/2002/97
4.3 Inventory
Report of the Co-ordinator
Report on botanicals XXIV/1828/98
Report on Section II of the inventory (Fragrances) SCCNFP/0022/98
4.4 Preservatives
Report of the Co-ordinator
Draft opinion on Benzylhemiformal (P21) SCCNFP/0033/98
Opinion on Boric acid, borates and tetraborates SCCNFP/0025/98
Opinion on Strontium lactate, nitrate and polycarboxylate SCCNFP/0044/98
4.5 UV Filters
Report of the Co-ordinator
Expert panel meeting "Sun Protection"
5. Report of the Chairman
Format and structure of the opinions of the Scientific Committees - SCCNFP/0000/98
Rules of Procedure of the SCCNFP SCCNFP/0042/98
6. Questions raised by DG III
Specific evaluation for children
Classification of substances
Definition of hair dyes type
Tattoos
7. Any other business
Planning plenary meetings in 1999
