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Directorate-General for Health and Food Safety
The Chairman, Prof. Kemper, welcomed the
participants of the meeting (see annex) and
introduced as guest speaker Dr. H. Driller,
accompanied by Mr. B. Berken and Dr. W Pape (COLIPA),
who was invited for a presentation and
discussion on Titanium dioxide.
Apologies were received from some members of the SCCNFP (see annex)
1. The use of Titanium dioxide in sunscreen formulations Discussion with industry experts
In the framework of the safety evaluation of Titanium dioxide for use in sun screen formulations, industry experts were invited to illustrate in particular the chemical/physical side of the issue.
Because of the photo-catalytic properties of uncoated Titanium dioxide, the committee was in particular interested to learn more about the various coatings (organic and inorganic) used to inhibit the photo-catalytic activity. Other items discussed were the uniformity of the coatings and their stability under in-use conditions such as mechanical stress, changes in temperature and pH. Questions were asked about the stability in time and possible interaction with other UV filters used in the formulation.
In the margin of the discussion, industry was asked if different CAS numbers and INCI names are used for Titanium dioxide as such and for its coated versions.
2. Adoption of the Agenda (doc. n° SCCNFP/0117/99) (Annex 1)
The agenda was adopted.
3. Approval of the minutes of the 6th plenary meeting of 20 January 1999
doc. n° SCCNFP/0116/99
The minutes were adopted.
4. SCCNFP - Specific Working Parties
4.1 UV Filters
Report of the Co-ordinator
In the absence of the Co-ordinator, Dr. Powell, Dr. White took the chair and reported on the work done since the previous plenary meeting. He said that an number of documents were discussed and prepared for formal adoption by the plenary meeting.
Draft opinions were prepared on :
S8 2-Ethylhexyl-4-dimethylaminobenzoate, doc n° SCCNFP/0101/99
S8 has been considered by the committee over a length of time and is one of the last three substances still listed in the list of provisionally allowed UV filters (Annex VII, part 2).
The draft opinion includes the evaluation of the reproductive toxicity study the committee asked for. Of concern were the findings of testicular changes and hypospermia noted at the highest dose administered. Although the lowest dose was used to calculate the margin of safety, it was suggested to ask Dr. Powell to re-examine the histo-pathological slides from that experiment.
The substance was given a classification 1 at a maximum concentration of 8%, subject to the findings of Dr. Powell. Only in case of a negative advice, the file will be re-addressed to the WP.
S16 4-Isopropylbenzyl salicylate, doc. n° SCCNFP/0118/99
By letter of 27 January 1999, COLIPA informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate has ceased the production of this ingredient as a UVB filter. Therefore, the requests for additional information on S16 made by the SCCNFP will not be answered and COLIPA will not request the prolongation of the provisional use of 4-Isopropylbenzyl salicylate nor its inclusion in Annex VII part 1 - list of permitted UV filters which cosmetic products may contain - of Directive 76/768/EEC.
As a consequence, the SCCNFP ceased the safety review of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations. An position was adopted accordingly.
S40 2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid, doc. n° SCCNFP/0085/98
The rapporteur said that the requested information was received and that the substance has been judged satisfactory for use in sunscreen formulation at the concentration stated in the document.
The document was adopted without further comments or modifications.
Classification adopted : 1 at a maximum concentration of 5 %, expressed as acid.
S8, S16 and S40 were the three remaining substances on the list of provisionally allowed UV filters for which the adoption of an opinion was pending.
S74 Benzylidene malonate polysiloxane, doc. n° SCCNFP/0079/98
The rapporteur said that the dossier on S74 was found complete and satisfactory. He remarked that the calculation of the Margin of Safety was made using the worst possible interpretation of the results of the percutaneous absorption study.
The document was adopted subject to some minor typographical errors and to the rewording of the mutagenicity/Genotoxicity part.
Classification adopted : 1 at a maximum concentration of 10%.
S79 2,2'-Methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol), doc. n° SCCNFP/0080/98
Also this dossier was found complete and satisfactory. The document was adopted subject to some minor typographical errors.
Classification adopted : 1 at a maximum concentration of 10%.
S80 2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6-disulfonic acid, monosodium salt, doc. n° SCCNFP/0081/98
S80 is also a new compound well supported by an extensive file of experimental work. Analogous to S74, the calculation of the Margin of Safety was made using the worst possible interpretation of the results of the percutaneous absorption study.
The document was adopted without further comments/modifications.
Classification adopted : 1 at a maximum concentration of 10%.
S81 2,4-bis-{[4-(2-Ethyl-hexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl) -(1,3,5)-triazine, doc. n° SCCNFP/0082/98
S81 is another new compound which dossier was found complete and satisfactory.
The document was adopted without further comments/modifications.
Classification adopted : 1 at a maximum concentration of 10%.
4.2 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
Concerning fragrances, Dr. White said that a meeting is foreseen on 23 February 99 with only fragrance ingredients on the agenda. Dr. Ladd Smith, the new chairman of RIFM, is invited to discuss RIFM's Criteria Document. RIFM uses this document for their toxicological assessment of fragrances.
A number of draft opinions were prepared by the WP on :
Restrictions on materials listed in Annex VI of Directive 76/768/EEC on cosmetic products, doc n° SCCNFP/0125/99
The assistance of the SCCNFP was requested by DG III with respect to the safety of the uses of materials listed in Annex VI of Directive 76/768/EEC for uses other than those of preservation. There are seven substances listed in Annex VI that bear the symbol (+) for which there are requirements concerning 'limitations and requirements' and 'conditions for use and warnings which must be printed on the label'.
The question to the SCCNFP was as to whether the requirements on limitations and labelling are valid when these chemicals are used in cosmetics for purposes other than for a preservative function.
As the toxicological effects of these substances will be the same for all potential uses of them and as a higher exposure as permitted by "other uses" could reasonably be expected to lead to increased toxicological hazard, the SCCNFP stated that those substances indicated by (+) in Annex VI, when incorporated into cosmetic formulations for non-preservative functions, should be subjected to the same restrictions in usage levels and warnings as when used for preservative effects.
Hydrogen(carbamide) peroxide in tooth whitening products, doc. n° SCCNFP/0058/98
The SCCNFP was asked whether the safety profile documented in the submission received supports the proposed increase in the permitted level of hydrogen peroxide (and equivalent) in tooth whitening products from 0.1% to 3.6%.
A draft opinion on the issue was approved at WP level and illustrated by the rapporteur.
As a result, the plenary meeting followed the proposed opinion and stated that tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"), that these products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
P21 Benzylhemiformal, doc. n° SCCNFP/0033/98
P21 has been discussed by the committee on a number of occasions over a period of time and is the last of the two remaining substances still listed in the list of provisionally allowed preservatives (Annex VI, part 2).
The rapporteur commented the tabled draft opinion which includes the evaluation of the additional information requested.
As a result, the committee approved the use of Benzylhemiformal (P21) as a preservative in rinse-off cosmetic formulations at a maximum concentration of 0.15%.
Classification adopted : 1 at 0.15% in rinse-off products.
Labelling of fragrance allergens
The rapporteur briefly reported on the state of the fragrance allergens document and said that it required only minor modifications/corrections. The final version will be tabled for approval during the WP meeting of 6-7.4.99.
4.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that, since the previous plenary meeting, the work of the WP consisted of the evaluation of the safety of hydroquinone as a hair dye constituent and of establishing the state of the pending hair dye files.
Draft opinion on :
Hydroquinone as a hair dye constituent, doc. n° SCCNFP/0078/98
The SCCNFP was asked for an opinion on the use of Hydroquinone as a coupler agent in oxidative hair dyes. Coupler agents in hair dyes are substances which induce or enhance chemical processes which lead to the formation of final dyes. Mostly a coupling substance itself disappears during the reaction time of about 10-30 minutes, within the first 10 minutes up to more than 70 %.
The SCCNFP concluded that the use of Hydroquinone as a constituent in oxidative hair dye formulations as a coupler is safe in this kind off rinse-off cosmetic products which moreover are applied for hair dyeing normally once a month.
Classification adopted : 1 as a oxidative hair dye constituent ('coupler') up to 0.3 %.
'Hair Dyes' Task Force
The committee was briefed about the results of the Task Force meeting which took place from 1 to 4 February 1999. Status reports were prepared on all pending issues and will serve as the basis for drafting the opinions.
In the margin of their work, the Task Force recommended that the Commission should establish a reliable data base of ingredients of cosmetic products in which a compilation of all relevant data, e.g. physico-chemical properties, toxicological characterisation, dermatological-experimental and clinical findings, are compiled. The proposed data bank could serve for scientific information as well as in several aspects also for administrative purposes in the sense of transparency and facilitating measurements.
A specific Task Force was set up to prepare a technical profile of the data base to be used by the Commission services to launch a call for tenders for its creation.
Memorandum on the sensitising potential of hair dyes
In the framework of the discussion, the Task Force prepared a "Memorandum" in which some thoughts on "Sensitisation and its predictive value" were laid down. The preparation of this paper was initiated by the fact that many of the hair dyes currently under evaluation, and PPD in particular, have had assessments of sensitising potential. It was made clear by the authors that this paper should not be considered as a SCCNFP position paper on but rather as a collection of thoughts for further consideration.
Hair Dye reference samples
The Committee re-addressed the Commission again concerning reference samples. The Committee repeated that they would very much appreciate if they, or the national laboratories, could dispose of hair dye reference samples to better understand the complexity of the hair dye issue. It was proposed that industry should enclose a sample with each new submission to the committee.
The representative of DG III said that the Member States have some thought in that direction, namely to include such a provision in the directive.
The Co-ordinator concluded his report by saying that he would, on behalf of the committee, express his enormous appreciation for the work undertaken by the Task Force.
4.4 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno referred to the outcome of the 6th plenary meeting of 20 January 1999 which was completely devoted to alternatives to animal testing. He said that a press release was made to underline the approval by the SCCNFP of the first alternatives methods to animal testing.
Concerning the on-going work, he said that the WP hopes to conclude by July 99 by means of a general opinion on the state of the art of alternatives in such a way that they can be considered to be validated and to be used for transposition into legislation. He stressed that the Committee is only entitled to consider validated methods applicable to cosmetics.
Approval of the Update of the second revision of the SCC's Notes of Guidance
The rapporteur said that the recently adopted opinions have been inserted in the Notes of Guidance and that the text was consequently amended in all aspects which were not longer relevant to the present situation.
He asked the members to go through this text and to make all necessary remarks/comments. Based on these comments, he will rework the text and present it in a future meeting for formal adoption.
Work Programme for 1999
The Co-ordinator was brief on this item by saying that the work programme for 1999 has been defined and the respective rapporteurs assigned.
4.5 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that a number of documents were discussed and prepared for formal adoption by the plenary meeting.
Status report on the inventory, doc. n° SCCNFP/0098/99
As a consequence of the discussions with COLIPA, the committee found it necessary to make a status report which emphasises the position of the committee on the way the inventory must be updated for the first time.
The committee formally adopted the paper which reflects the state of the art at present.
Draft opinion on pseudo INCI names of botanicals, doc. n° SCCNFP/0099/99
This paper refers to those botanicals listed in the inventory under the rubric 'INCI names', but which are not the names used in the International Cosmetic Ingredients Dictionary. The paper stresses the need for internationally accepted nomenclature in this respect and for new conventions to be considered. The paper is also an application of the principles adopted by the committee on the updating of the inventory concerning botanicals.
The document was adopted by the plenary as a position paper and should serve as a guidance to improve these entries. A formal opinion will follow.
Draft opinion on the banning dialkanolamines, doc. n° SCCNFP/0110/99
The documents concerns the issue of dialkanolamines which are still present in the inventory although they must not form part of the composition of cosmetic products (Annex II, n° 411). In fact, they should be removed from the Inventory.
The committee adopted the document without further discussion.
Draft opinion on corrections of entries on poloxamers, meroxamers and poloxamines, doc. n° SCCNFP/0111/99
The document refers to the corrections to be made on the respective entries in the inventory and to the revision of the respective nomenclature conventions.
The committee adopted the document without further discussion.
5 Report of the Chairman
In his report, Prof. Kemper informed the members about the newly received requests for safety review :
* A request the review the safety of 2,4-Diamino-pirimidine-3-oxide (2,4-DPO) was received. A special working group was set up to prepare a draft opinion.
6. Any Other Business
* Sun beds : in response to a question raised on the subject, the committee was informed that, indeed, this issue falls within the field of competence of the SCCNFP. The chairman said that it will be given appropriate consideration if the committee is asked to do so.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, 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 D. O'Mahony external expert.
Commission : Mr L. Bansil DG III, Mrs L. Benali DG XXIV, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr G. Fracchia DG XII, Mr A. Van Elst DG XXIV.
Industry : Mr B. Berken COLIPA, Mr H. Driller COLIPA, Mr W. Pape COLIPA.
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, Mr P. Elsner, Mr B. Lina, Mr C.J. Powell.
Scientific Committee on Cosmetic and Non-Food Products - Agenda for the 7th plenary meeting (Brussels, 17 February 1999)
1. The use of Titanium dioxide in sun screen formulations
Discussion with industry experts
2. Adoption of the agenda SCCNFP/0117/99
3. Approval of the minutes of the 6th plenary meeting of 20.1.99 SCCNFP/0116/99
4. SCCNFP - Specific Working Parties
4.1 UV Filters
Report of the Co-ordinator
Draft opinions on :
* S8 2-Ethylhexyl-4-dimethylaminobenzoate SCCNFP/0101/99
* S16 4-Isopropylbenzyl salicylate SCCNFP/0118/99
* S40 2-Hydroxy-4-methoxybenzophenone-5- sulphonic acid SCCNFP/0085/98
* S74 a -(trimethylsilyl)-w -[(trimethylsilyl)oxy]poly [oxy (dimethyl SCCNFP/0079/98
* S79 2,2'-Methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol) SCCNFP/0080/98
* S80 2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6- disulfonic acid, monosodium salt) SCCNFP/0081/98
* S81 2,4-bis-{[4-(2-Ethyl-hexyloxy)-2-hydroxy]-phenyl}-6 -(4-methoxyphenyl)-(1,3,5)-triazine SCCNFP/0082/98
4.2 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinions on :
* the use of carbamide peroxide in teeth bleaching products SCCNFP/0058/98
* Benzylhemiformal (P21) SCCNFP/0033/98
4.3 Hair Dyes
Report of the Co-ordinator
Draft opinion on :
* Hydroquinone as a hair dye constituent SCCNFP/0078/98
4.4 Alternatives
Report of the Co-ordinator
Approval of the Update of the second revision of the SCC's Notes of Guidance
rapporteur : Prof. Loprieno
Work Programme for 1999 SCCNFP/0113/99
4.5 Inventory
Report of the Co-ordinator
* Status report on the inventory SCCNFP/0098/99 rapporteurs : Prof. Parra, Dr. Pons Gimier
* draft opinion on pseudo INCI names of botanicals SCCNFP/0099/99 rapp. : Prof. Kapoulas, Prof. Parra, Dr. Pons Gimier
* draft opinion on the banning dialkanolamines SCCNFP/0110/99 rapporteur : Prof. Kapoulas
* draft opinion on corrections of entries on poloxamers, meroxamers and poloxamines SCCNFP/0111/99
rapporteur : Prof. Kapoulas
5. Report of the Chairman
6. Any other business
* sun beds
Apologies were received from some members of the SCCNFP (see annex)
1. The use of Titanium dioxide in sunscreen formulations Discussion with industry experts
In the framework of the safety evaluation of Titanium dioxide for use in sun screen formulations, industry experts were invited to illustrate in particular the chemical/physical side of the issue.
Because of the photo-catalytic properties of uncoated Titanium dioxide, the committee was in particular interested to learn more about the various coatings (organic and inorganic) used to inhibit the photo-catalytic activity. Other items discussed were the uniformity of the coatings and their stability under in-use conditions such as mechanical stress, changes in temperature and pH. Questions were asked about the stability in time and possible interaction with other UV filters used in the formulation.
In the margin of the discussion, industry was asked if different CAS numbers and INCI names are used for Titanium dioxide as such and for its coated versions.
2. Adoption of the Agenda (doc. n° SCCNFP/0117/99) (Annex 1)
The agenda was adopted.
3. Approval of the minutes of the 6th plenary meeting of 20 January 1999
doc. n° SCCNFP/0116/99
The minutes were adopted.
4. SCCNFP - Specific Working Parties
4.1 UV Filters
Report of the Co-ordinator
In the absence of the Co-ordinator, Dr. Powell, Dr. White took the chair and reported on the work done since the previous plenary meeting. He said that an number of documents were discussed and prepared for formal adoption by the plenary meeting.
Draft opinions were prepared on :
S8 2-Ethylhexyl-4-dimethylaminobenzoate, doc n° SCCNFP/0101/99
S8 has been considered by the committee over a length of time and is one of the last three substances still listed in the list of provisionally allowed UV filters (Annex VII, part 2).
The draft opinion includes the evaluation of the reproductive toxicity study the committee asked for. Of concern were the findings of testicular changes and hypospermia noted at the highest dose administered. Although the lowest dose was used to calculate the margin of safety, it was suggested to ask Dr. Powell to re-examine the histo-pathological slides from that experiment.
The substance was given a classification 1 at a maximum concentration of 8%, subject to the findings of Dr. Powell. Only in case of a negative advice, the file will be re-addressed to the WP.
S16 4-Isopropylbenzyl salicylate, doc. n° SCCNFP/0118/99
By letter of 27 January 1999, COLIPA informed the European Commission that the manufacturer of 4-Isopropylbenzyl salicylate has ceased the production of this ingredient as a UVB filter. Therefore, the requests for additional information on S16 made by the SCCNFP will not be answered and COLIPA will not request the prolongation of the provisional use of 4-Isopropylbenzyl salicylate nor its inclusion in Annex VII part 1 - list of permitted UV filters which cosmetic products may contain - of Directive 76/768/EEC.
As a consequence, the SCCNFP ceased the safety review of 4-Isopropylbenzyl salicylate in cosmetic sunscreen formulations. An position was adopted accordingly.
S40 2-Hydroxy-4-methoxybenzophenone-5-sulphonic acid, doc. n° SCCNFP/0085/98
The rapporteur said that the requested information was received and that the substance has been judged satisfactory for use in sunscreen formulation at the concentration stated in the document.
The document was adopted without further comments or modifications.
Classification adopted : 1 at a maximum concentration of 5 %, expressed as acid.
S8, S16 and S40 were the three remaining substances on the list of provisionally allowed UV filters for which the adoption of an opinion was pending.
S74 Benzylidene malonate polysiloxane, doc. n° SCCNFP/0079/98
The rapporteur said that the dossier on S74 was found complete and satisfactory. He remarked that the calculation of the Margin of Safety was made using the worst possible interpretation of the results of the percutaneous absorption study.
The document was adopted subject to some minor typographical errors and to the rewording of the mutagenicity/Genotoxicity part.
Classification adopted : 1 at a maximum concentration of 10%.
S79 2,2'-Methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol), doc. n° SCCNFP/0080/98
Also this dossier was found complete and satisfactory. The document was adopted subject to some minor typographical errors.
Classification adopted : 1 at a maximum concentration of 10%.
S80 2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6-disulfonic acid, monosodium salt, doc. n° SCCNFP/0081/98
S80 is also a new compound well supported by an extensive file of experimental work. Analogous to S74, the calculation of the Margin of Safety was made using the worst possible interpretation of the results of the percutaneous absorption study.
The document was adopted without further comments/modifications.
Classification adopted : 1 at a maximum concentration of 10%.
S81 2,4-bis-{[4-(2-Ethyl-hexyloxy)-2-hydroxy]-phenyl}-6-(4-methoxyphenyl) -(1,3,5)-triazine, doc. n° SCCNFP/0082/98
S81 is another new compound which dossier was found complete and satisfactory.
The document was adopted without further comments/modifications.
Classification adopted : 1 at a maximum concentration of 10%.
4.2 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
Concerning fragrances, Dr. White said that a meeting is foreseen on 23 February 99 with only fragrance ingredients on the agenda. Dr. Ladd Smith, the new chairman of RIFM, is invited to discuss RIFM's Criteria Document. RIFM uses this document for their toxicological assessment of fragrances.
A number of draft opinions were prepared by the WP on :
Restrictions on materials listed in Annex VI of Directive 76/768/EEC on cosmetic products, doc n° SCCNFP/0125/99
The assistance of the SCCNFP was requested by DG III with respect to the safety of the uses of materials listed in Annex VI of Directive 76/768/EEC for uses other than those of preservation. There are seven substances listed in Annex VI that bear the symbol (+) for which there are requirements concerning 'limitations and requirements' and 'conditions for use and warnings which must be printed on the label'.
The question to the SCCNFP was as to whether the requirements on limitations and labelling are valid when these chemicals are used in cosmetics for purposes other than for a preservative function.
As the toxicological effects of these substances will be the same for all potential uses of them and as a higher exposure as permitted by "other uses" could reasonably be expected to lead to increased toxicological hazard, the SCCNFP stated that those substances indicated by (+) in Annex VI, when incorporated into cosmetic formulations for non-preservative functions, should be subjected to the same restrictions in usage levels and warnings as when used for preservative effects.
Hydrogen(carbamide) peroxide in tooth whitening products, doc. n° SCCNFP/0058/98
The SCCNFP was asked whether the safety profile documented in the submission received supports the proposed increase in the permitted level of hydrogen peroxide (and equivalent) in tooth whitening products from 0.1% to 3.6%.
A draft opinion on the issue was approved at WP level and illustrated by the rapporteur.
As a result, the plenary meeting followed the proposed opinion and stated that tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"), that these products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
P21 Benzylhemiformal, doc. n° SCCNFP/0033/98
P21 has been discussed by the committee on a number of occasions over a period of time and is the last of the two remaining substances still listed in the list of provisionally allowed preservatives (Annex VI, part 2).
The rapporteur commented the tabled draft opinion which includes the evaluation of the additional information requested.
As a result, the committee approved the use of Benzylhemiformal (P21) as a preservative in rinse-off cosmetic formulations at a maximum concentration of 0.15%.
Classification adopted : 1 at 0.15% in rinse-off products.
Labelling of fragrance allergens
The rapporteur briefly reported on the state of the fragrance allergens document and said that it required only minor modifications/corrections. The final version will be tabled for approval during the WP meeting of 6-7.4.99.
4.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that, since the previous plenary meeting, the work of the WP consisted of the evaluation of the safety of hydroquinone as a hair dye constituent and of establishing the state of the pending hair dye files.
Draft opinion on :
Hydroquinone as a hair dye constituent, doc. n° SCCNFP/0078/98
The SCCNFP was asked for an opinion on the use of Hydroquinone as a coupler agent in oxidative hair dyes. Coupler agents in hair dyes are substances which induce or enhance chemical processes which lead to the formation of final dyes. Mostly a coupling substance itself disappears during the reaction time of about 10-30 minutes, within the first 10 minutes up to more than 70 %.
The SCCNFP concluded that the use of Hydroquinone as a constituent in oxidative hair dye formulations as a coupler is safe in this kind off rinse-off cosmetic products which moreover are applied for hair dyeing normally once a month.
Classification adopted : 1 as a oxidative hair dye constituent ('coupler') up to 0.3 %.
'Hair Dyes' Task Force
The committee was briefed about the results of the Task Force meeting which took place from 1 to 4 February 1999. Status reports were prepared on all pending issues and will serve as the basis for drafting the opinions.
In the margin of their work, the Task Force recommended that the Commission should establish a reliable data base of ingredients of cosmetic products in which a compilation of all relevant data, e.g. physico-chemical properties, toxicological characterisation, dermatological-experimental and clinical findings, are compiled. The proposed data bank could serve for scientific information as well as in several aspects also for administrative purposes in the sense of transparency and facilitating measurements.
A specific Task Force was set up to prepare a technical profile of the data base to be used by the Commission services to launch a call for tenders for its creation.
Memorandum on the sensitising potential of hair dyes
In the framework of the discussion, the Task Force prepared a "Memorandum" in which some thoughts on "Sensitisation and its predictive value" were laid down. The preparation of this paper was initiated by the fact that many of the hair dyes currently under evaluation, and PPD in particular, have had assessments of sensitising potential. It was made clear by the authors that this paper should not be considered as a SCCNFP position paper on but rather as a collection of thoughts for further consideration.
Hair Dye reference samples
The Committee re-addressed the Commission again concerning reference samples. The Committee repeated that they would very much appreciate if they, or the national laboratories, could dispose of hair dye reference samples to better understand the complexity of the hair dye issue. It was proposed that industry should enclose a sample with each new submission to the committee.
The representative of DG III said that the Member States have some thought in that direction, namely to include such a provision in the directive.
The Co-ordinator concluded his report by saying that he would, on behalf of the committee, express his enormous appreciation for the work undertaken by the Task Force.
4.4 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno referred to the outcome of the 6th plenary meeting of 20 January 1999 which was completely devoted to alternatives to animal testing. He said that a press release was made to underline the approval by the SCCNFP of the first alternatives methods to animal testing.
Concerning the on-going work, he said that the WP hopes to conclude by July 99 by means of a general opinion on the state of the art of alternatives in such a way that they can be considered to be validated and to be used for transposition into legislation. He stressed that the Committee is only entitled to consider validated methods applicable to cosmetics.
Approval of the Update of the second revision of the SCC's Notes of Guidance
The rapporteur said that the recently adopted opinions have been inserted in the Notes of Guidance and that the text was consequently amended in all aspects which were not longer relevant to the present situation.
He asked the members to go through this text and to make all necessary remarks/comments. Based on these comments, he will rework the text and present it in a future meeting for formal adoption.
Work Programme for 1999
The Co-ordinator was brief on this item by saying that the work programme for 1999 has been defined and the respective rapporteurs assigned.
4.5 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that a number of documents were discussed and prepared for formal adoption by the plenary meeting.
Status report on the inventory, doc. n° SCCNFP/0098/99
As a consequence of the discussions with COLIPA, the committee found it necessary to make a status report which emphasises the position of the committee on the way the inventory must be updated for the first time.
The committee formally adopted the paper which reflects the state of the art at present.
Draft opinion on pseudo INCI names of botanicals, doc. n° SCCNFP/0099/99
This paper refers to those botanicals listed in the inventory under the rubric 'INCI names', but which are not the names used in the International Cosmetic Ingredients Dictionary. The paper stresses the need for internationally accepted nomenclature in this respect and for new conventions to be considered. The paper is also an application of the principles adopted by the committee on the updating of the inventory concerning botanicals.
The document was adopted by the plenary as a position paper and should serve as a guidance to improve these entries. A formal opinion will follow.
Draft opinion on the banning dialkanolamines, doc. n° SCCNFP/0110/99
The documents concerns the issue of dialkanolamines which are still present in the inventory although they must not form part of the composition of cosmetic products (Annex II, n° 411). In fact, they should be removed from the Inventory.
The committee adopted the document without further discussion.
Draft opinion on corrections of entries on poloxamers, meroxamers and poloxamines, doc. n° SCCNFP/0111/99
The document refers to the corrections to be made on the respective entries in the inventory and to the revision of the respective nomenclature conventions.
The committee adopted the document without further discussion.
5 Report of the Chairman
In his report, Prof. Kemper informed the members about the newly received requests for safety review :
* A request the review the safety of 2,4-Diamino-pirimidine-3-oxide (2,4-DPO) was received. A special working group was set up to prepare a draft opinion.
6. Any Other Business
* Sun beds : in response to a question raised on the subject, the committee was informed that, indeed, this issue falls within the field of competence of the SCCNFP. The chairman said that it will be given appropriate consideration if the committee is asked to do so.
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr V. Kapoulas, Mr F. Kemper, 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 D. O'Mahony external expert.
Commission : Mr L. Bansil DG III, Mrs L. Benali DG XXIV, Mrs P. Decamps DG XXIV, Mrs M. de Solà DG XXIV, Mrs F. Drion DG XXIV, Mr G. Fracchia DG XII, Mr A. Van Elst DG XXIV.
Industry : Mr B. Berken COLIPA, Mr H. Driller COLIPA, Mr W. Pape COLIPA.
Apologies : Mr P. Blain, Mrs Y. De Roeck-Holtzhauer, Mr P. Elsner, Mr B. Lina, Mr C.J. Powell.
Scientific Committee on Cosmetic and Non-Food Products - Agenda for the 7th plenary meeting (Brussels, 17 February 1999)
1. The use of Titanium dioxide in sun screen formulations
Discussion with industry experts
2. Adoption of the agenda SCCNFP/0117/99
3. Approval of the minutes of the 6th plenary meeting of 20.1.99 SCCNFP/0116/99
4. SCCNFP - Specific Working Parties
4.1 UV Filters
Report of the Co-ordinator
Draft opinions on :
* S8 2-Ethylhexyl-4-dimethylaminobenzoate SCCNFP/0101/99
* S16 4-Isopropylbenzyl salicylate SCCNFP/0118/99
* S40 2-Hydroxy-4-methoxybenzophenone-5- sulphonic acid SCCNFP/0085/98
* S74 a -(trimethylsilyl)-w -[(trimethylsilyl)oxy]poly [oxy (dimethyl SCCNFP/0079/98
* S79 2,2'-Methylene-bis-(6(2H-benzotriazol-2-yl)-4- (1,1,3,3-tetramethylbutyl)phenol) SCCNFP/0080/98
* S80 2,2'-(1,4-Phenylene)bis)-1H-benzimidazole-4,6- disulfonic acid, monosodium salt) SCCNFP/0081/98
* S81 2,4-bis-{[4-(2-Ethyl-hexyloxy)-2-hydroxy]-phenyl}-6 -(4-methoxyphenyl)-(1,3,5)-triazine SCCNFP/0082/98
4.2 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinions on :
* the use of carbamide peroxide in teeth bleaching products SCCNFP/0058/98
* Benzylhemiformal (P21) SCCNFP/0033/98
4.3 Hair Dyes
Report of the Co-ordinator
Draft opinion on :
* Hydroquinone as a hair dye constituent SCCNFP/0078/98
4.4 Alternatives
Report of the Co-ordinator
Approval of the Update of the second revision of the SCC's Notes of Guidance
rapporteur : Prof. Loprieno
Work Programme for 1999 SCCNFP/0113/99
4.5 Inventory
Report of the Co-ordinator
* Status report on the inventory SCCNFP/0098/99 rapporteurs : Prof. Parra, Dr. Pons Gimier
* draft opinion on pseudo INCI names of botanicals SCCNFP/0099/99 rapp. : Prof. Kapoulas, Prof. Parra, Dr. Pons Gimier
* draft opinion on the banning dialkanolamines SCCNFP/0110/99 rapporteur : Prof. Kapoulas
* draft opinion on corrections of entries on poloxamers, meroxamers and poloxamines SCCNFP/0111/99
rapporteur : Prof. Kapoulas
5. Report of the Chairman
6. Any other business
* sun beds
