- General information enquiries
- Call 00 800 6 7 8 9 10 11
- E-mail your questions
Directorate-General for Health and Food Safety
1. Lecture by Dr. J.-F. Doré
on sunscreens
Dr. Doré presented the results of epidemiological studies on the use of sunscreens and the risk of skin cancer.
The lecture was followed by a discussion.
2. Adoption of the Agenda
The agenda was adopted subject to the following modifications :
* point 2 - Declaration of interest will be discussed under point 6 - Any Other Business
* point 6 - Any Other Business : add 'Notes of Guidance' and 'Rules of Procedure'
3. Approval of the minutes of the 1st plenary meeting of 14.11.97
The minutes were adopted subject to the following modifications :
* add the attendance list
* page 4, point 8 - Any Other Business, Fragrances : add "and this was agreed" at the end of the sentence.
* correction of the typographical errors.
4. SCCNFP - Specific Working Parties
4.1 UV-Filters
The minutes of the meeting of 16.12.97 were presented for information only as they were not yet approved by the Working Group.
UVASORB HEB - doc. n° XXIV/1873, rev. 1/98
The data on the percutaneous absorption and the photo-sensitisation studies, their respective methodologies as well as the data on the photo-stability of the compound were further discussed and the final version of the opinion was adapted in this respect.
As a consequence, the Committee considered that all the data of the dossier were sufficient to deliver a favourable opinion.
A classification 1 was adopted at a maximum concentration of 10%.
S13 : 2-Ethylhexyl salicylate - doc. n° XXIV/1860/95, rev. 1/98
The discussion focused mainly on the dermal versus oral NOAEL. It was decided to use the oral NOAEL for the calculation of the Margin of Safety. As a consequence, the Committee considered that all the data of the dossier were sufficient to deliver a favourable opinion.
A classification 1 was adopted at a maximum concentration of 5%.
S60 : 3-(4'-Methylbenzylidene)D,L-camphor - doc. n° XXIV/1377/96, rev. 1/98
The rapporteur re-evaluated the data on the absorption rate and concluded that an absorption rate of 1.9% was to be used in the calculation of the Margin of Safety. Moreover, and in contradiction with what is mentioned in the submission, industry declared to accept an in-use-level of 4%, which yielded an acceptable Margin of Safety.
The methodology of the sensitisation study and the effects of the ingredient on thyroid function were further discussed.
A classification 1 was adopted at a maximum concentration of 4%.
S61 : 3-Benzylidene-bornan-2-one - doc. n° XXIV/1374/96, rev.1/98
This compound has similar effects on thyroid function as S60. The rapporteur communicated his findings on the photo-stability and on the photo-isomerisation of the compound. He said that the tests were carried out to a satisfactory protocol.
A classification 1 was adopted at a maximum concentration of 2%.
4.2 Hydroquinone
The chairman illustrated this long-standing issue. He informed the members about the outcome of a special meeting on the subject, which took place on 20.1.98.
The main points of concern were the concentration of Hydroquinone in the formulation and its pharmacological mode of action. At what concentration, the formulation should be regarded as a cosmetic or as a pharmaceutical product.
It was decided to discuss the dose/effect relationship and the pharmaceutical mode of action of Hydroquinone in the meeting of the Working Party 'Hair Dyes' of 18.2.98.
4.3 Angelopharm
The rapporteur illustrated in a concise way the history of this file, which consists of 16 substances listed in Annex II of the cosmetics directive. As the documents tabled were already discussed in length in the past, the meeting was asked not to go once again page by page through these documents, but to go straight to their respective conclusions.
* 11-a -Hydroxypregn-4-ene,3,20-dione and esters doc. n° XXIV/1990/97
* AETT doc. n° XXIV/1991/97
* Aristolochic acid and salts doc. n° XXIV/1991/97
The Committee decided to expand the present entry in Annex II to Aristolochia species and preparations.
* Acetonitrile doc. n° XXIV/1991/97
Findings on the genotoxicity should be inserted to the conclusions.
* 2,3,7,8 Tetrachlorodibenzo-p-dioxin doc. n° XXIV/1991/97
* Tribromsalan doc. n° XXIV/1991/97
* C.I.42 640 doc. n° XXIV/1991/97
* Anti-androgens with steroid structure doc. n° XXIV/1992/97
The entry n° 390 should be modified as to read 'Substances with anti-androgenic effect' in order to have the same type of wording as for entry n° 37 'Substances with androgenic effect'
* Minoxidil salt and derivatives doc. n° XXIV/1992/97
* Tyrothricine doc. n° XXIV/1992/97
* Tetrahydrozoline and salts (hydrochloride) doc. n° XXIV/1992/97
* Phytolacca spp. and preparations doc. n° XXIV/1992/9
* Zirconium and compounds doc. n° XXIV/1993/97
The entry should read 'Zirconium and compounds with the exclusion of those listed in Annex III and IV'.
As a result of the discussion and subject to the modification to be made for the respective substances, a classification 2a was adopted for all these substances
* Strontium lactate, nitrate, polycarboxylate doc. n° XXIV/1993/97
These three substances were put in Annex II by the 15th Commission Directive on adaptation to technical progress of the cosmetics directive.
However, the rational behind this decision was not clear to the Committee. Therefore, the Commission was asked to check their files to find the documents, which justified their inclusion in Annex II. The Committee will convene in due course to further discuss this issue.
The Committee decided to postpone the classification of these Strontium compounds.
4.4 Hair Dyes
The Co-ordinator mentioned that there had been no meeting of the WP 'Hair Dyes' since the renewal of the Committee took place, and as a consequence, there was nothing to report on beside the fact that the next meeting of this WP was planned on 18.2.98.
4.5 Preservatives
The Co-ordinator said that also the WP 'Preservatives, Colorants & Fragrances' did not meet yet. However, he mentioned that the WP would resume its work very soon. Particular attention would be given on the various aspects of consumer safety in relation to the use of fragrances. A letter from the Danish Authorities was received in this respect.
The Co-ordinator mentioned as well that Dr. J.D. Johansen, Department of Dermatology, Gentofte Hospital was invited to contribute, as a specialised external expert, to the work of the committee on fragrance ingredients.
4.6 Inventory
Neither had this WP yet met under its new configuration. The Co-ordinator mentioned that a lot of material was received through DG III on corrections to be made on entries in the inventory. The updating of the inventory will be done in close collaboration with the Joint Research Centre in Ispra.
DG III informed the Committee Members of the fact that an electronic version of the inventory is now available on request. Moreover, the inventory will be put on the homepage of DG III in the near future.
4.7 Alternatives - Test on Humans
The Co-ordinator informed the members about the meetings planned so far in this domain. He gave an overview of the various points on the agenda's.
5. Report of the Chairman
The chairman gave a short overview of all pending issue, which he would summarise in a note. He also mentioned that he would report more in detail during next plenary meeting.
6. Any Other Business
* As a general remark, it was said that some studies, and especially those on ingredients of the provisional lists in the Annexes of the directive, were not performed according to the present or most recent OECD guidelines due to the fact that the procedures changed in the mean time. Therefore, the respective rapporteurs were asked to include a remark in this respect in their conclusion. Although the Committee concluded to fully support the decisions taken so far, it was said that this point should be taken into account during future evaluations.
* In line with the above comment, it was mentioned to request the cosmetic industry to include, especially for 'old' ingredients, reported clinical data.
* The Chairman mentioned that an error was found in the 2nd version of the Notes of Guidance. The necessary corrections will be made and copies distributed.
* The Chairman said that he received from the members comments on the draft Rules of Procedure. He stressed that these Rules of Procedure were not drafted for a specific scientific committee but that they should be apply for all 9 committees, the steering committee included. He invited the members not to go in detail today. He will prepare a table, which contains all comments received and will present it for discussion.
Attendance List
Present :
Mr K. Andersen, Mr R. Anton, Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, 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
Mrs M.-O. Masse, Mr D. O'Mahony
Commission :
Mr L. Bansil DG III, Mrs M. Bernard DG III, Mr W. De Klerck DG XXIV, Mrs S. Van de Louw G XXIV, Mr A. Van Elst DG XXIV
Dr. Doré presented the results of epidemiological studies on the use of sunscreens and the risk of skin cancer.
The lecture was followed by a discussion.
2. Adoption of the Agenda
The agenda was adopted subject to the following modifications :
* point 2 - Declaration of interest will be discussed under point 6 - Any Other Business
* point 6 - Any Other Business : add 'Notes of Guidance' and 'Rules of Procedure'
3. Approval of the minutes of the 1st plenary meeting of 14.11.97
The minutes were adopted subject to the following modifications :
* add the attendance list
* page 4, point 8 - Any Other Business, Fragrances : add "and this was agreed" at the end of the sentence.
* correction of the typographical errors.
4. SCCNFP - Specific Working Parties
4.1 UV-Filters
The minutes of the meeting of 16.12.97 were presented for information only as they were not yet approved by the Working Group.
UVASORB HEB - doc. n° XXIV/1873, rev. 1/98
The data on the percutaneous absorption and the photo-sensitisation studies, their respective methodologies as well as the data on the photo-stability of the compound were further discussed and the final version of the opinion was adapted in this respect.
As a consequence, the Committee considered that all the data of the dossier were sufficient to deliver a favourable opinion.
A classification 1 was adopted at a maximum concentration of 10%.
S13 : 2-Ethylhexyl salicylate - doc. n° XXIV/1860/95, rev. 1/98
The discussion focused mainly on the dermal versus oral NOAEL. It was decided to use the oral NOAEL for the calculation of the Margin of Safety. As a consequence, the Committee considered that all the data of the dossier were sufficient to deliver a favourable opinion.
A classification 1 was adopted at a maximum concentration of 5%.
S60 : 3-(4'-Methylbenzylidene)D,L-camphor - doc. n° XXIV/1377/96, rev. 1/98
The rapporteur re-evaluated the data on the absorption rate and concluded that an absorption rate of 1.9% was to be used in the calculation of the Margin of Safety. Moreover, and in contradiction with what is mentioned in the submission, industry declared to accept an in-use-level of 4%, which yielded an acceptable Margin of Safety.
The methodology of the sensitisation study and the effects of the ingredient on thyroid function were further discussed.
A classification 1 was adopted at a maximum concentration of 4%.
S61 : 3-Benzylidene-bornan-2-one - doc. n° XXIV/1374/96, rev.1/98
This compound has similar effects on thyroid function as S60. The rapporteur communicated his findings on the photo-stability and on the photo-isomerisation of the compound. He said that the tests were carried out to a satisfactory protocol.
A classification 1 was adopted at a maximum concentration of 2%.
4.2 Hydroquinone
The chairman illustrated this long-standing issue. He informed the members about the outcome of a special meeting on the subject, which took place on 20.1.98.
The main points of concern were the concentration of Hydroquinone in the formulation and its pharmacological mode of action. At what concentration, the formulation should be regarded as a cosmetic or as a pharmaceutical product.
It was decided to discuss the dose/effect relationship and the pharmaceutical mode of action of Hydroquinone in the meeting of the Working Party 'Hair Dyes' of 18.2.98.
4.3 Angelopharm
The rapporteur illustrated in a concise way the history of this file, which consists of 16 substances listed in Annex II of the cosmetics directive. As the documents tabled were already discussed in length in the past, the meeting was asked not to go once again page by page through these documents, but to go straight to their respective conclusions.
* 11-a -Hydroxypregn-4-ene,3,20-dione and esters doc. n° XXIV/1990/97
* AETT doc. n° XXIV/1991/97
* Aristolochic acid and salts doc. n° XXIV/1991/97
The Committee decided to expand the present entry in Annex II to Aristolochia species and preparations.
* Acetonitrile doc. n° XXIV/1991/97
Findings on the genotoxicity should be inserted to the conclusions.
* 2,3,7,8 Tetrachlorodibenzo-p-dioxin doc. n° XXIV/1991/97
* Tribromsalan doc. n° XXIV/1991/97
* C.I.42 640 doc. n° XXIV/1991/97
* Anti-androgens with steroid structure doc. n° XXIV/1992/97
The entry n° 390 should be modified as to read 'Substances with anti-androgenic effect' in order to have the same type of wording as for entry n° 37 'Substances with androgenic effect'
* Minoxidil salt and derivatives doc. n° XXIV/1992/97
* Tyrothricine doc. n° XXIV/1992/97
* Tetrahydrozoline and salts (hydrochloride) doc. n° XXIV/1992/97
* Phytolacca spp. and preparations doc. n° XXIV/1992/9
* Zirconium and compounds doc. n° XXIV/1993/97
The entry should read 'Zirconium and compounds with the exclusion of those listed in Annex III and IV'.
As a result of the discussion and subject to the modification to be made for the respective substances, a classification 2a was adopted for all these substances
* Strontium lactate, nitrate, polycarboxylate doc. n° XXIV/1993/97
These three substances were put in Annex II by the 15th Commission Directive on adaptation to technical progress of the cosmetics directive.
However, the rational behind this decision was not clear to the Committee. Therefore, the Commission was asked to check their files to find the documents, which justified their inclusion in Annex II. The Committee will convene in due course to further discuss this issue.
The Committee decided to postpone the classification of these Strontium compounds.
4.4 Hair Dyes
The Co-ordinator mentioned that there had been no meeting of the WP 'Hair Dyes' since the renewal of the Committee took place, and as a consequence, there was nothing to report on beside the fact that the next meeting of this WP was planned on 18.2.98.
4.5 Preservatives
The Co-ordinator said that also the WP 'Preservatives, Colorants & Fragrances' did not meet yet. However, he mentioned that the WP would resume its work very soon. Particular attention would be given on the various aspects of consumer safety in relation to the use of fragrances. A letter from the Danish Authorities was received in this respect.
The Co-ordinator mentioned as well that Dr. J.D. Johansen, Department of Dermatology, Gentofte Hospital was invited to contribute, as a specialised external expert, to the work of the committee on fragrance ingredients.
4.6 Inventory
Neither had this WP yet met under its new configuration. The Co-ordinator mentioned that a lot of material was received through DG III on corrections to be made on entries in the inventory. The updating of the inventory will be done in close collaboration with the Joint Research Centre in Ispra.
DG III informed the Committee Members of the fact that an electronic version of the inventory is now available on request. Moreover, the inventory will be put on the homepage of DG III in the near future.
4.7 Alternatives - Test on Humans
The Co-ordinator informed the members about the meetings planned so far in this domain. He gave an overview of the various points on the agenda's.
5. Report of the Chairman
The chairman gave a short overview of all pending issue, which he would summarise in a note. He also mentioned that he would report more in detail during next plenary meeting.
6. Any Other Business
* As a general remark, it was said that some studies, and especially those on ingredients of the provisional lists in the Annexes of the directive, were not performed according to the present or most recent OECD guidelines due to the fact that the procedures changed in the mean time. Therefore, the respective rapporteurs were asked to include a remark in this respect in their conclusion. Although the Committee concluded to fully support the decisions taken so far, it was said that this point should be taken into account during future evaluations.
* In line with the above comment, it was mentioned to request the cosmetic industry to include, especially for 'old' ingredients, reported clinical data.
* The Chairman mentioned that an error was found in the 2nd version of the Notes of Guidance. The necessary corrections will be made and copies distributed.
* The Chairman said that he received from the members comments on the draft Rules of Procedure. He stressed that these Rules of Procedure were not drafted for a specific scientific committee but that they should be apply for all 9 committees, the steering committee included. He invited the members not to go in detail today. He will prepare a table, which contains all comments received and will present it for discussion.
Attendance List
Present :
Mr K. Andersen, Mr R. Anton, Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, 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
Mrs M.-O. Masse, Mr D. O'Mahony
Commission :
Mr L. Bansil DG III, Mrs M. Bernard DG III, Mr W. De Klerck DG XXIV, Mrs S. Van de Louw G XXIV, Mr A. Van Elst DG XXIV
