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Directorate-General for Health and Food Safety
Prof. Kemper, the chairman of the SCCNFP
welcomed all participants.
1. Adoption of the Agenda (doc. n° SCCNFP/0332/00) (Annex 1)
The agenda was adopted.
2. Declaration of interest
No interests were declared.
3. Approval of the minutes of the 11th plenary meeting of 17 February 2000, doc. n° SCCNFP/0307/00
The minutes were adopted, together with special thanks to the secretariat.
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Prof. Loprieno said that two documents were prepared by the Working Party and addressed to the plenary : the draft opinion on the Murine Local Lymph Node Assay (LLNA) and a revision of the Notes of Guidance.
In his report, Prof. Loprieno mentioned as well that the Working Party was informed about Guidelines DG ENTR is preparing for Small and Medium Size Enterprises (SME's) concerning the safety evaluation of cosmetics. He invited the Commission to present this document, as soon as it is finalised, to the SCCNFP for opinion.
Draft opinion on the Murine Local Lymph Node Assay (LLNA), doc. n° SCCNFP/0255/00 rev. 2
The Murine Local Lymph Node Assay is a test method which can be used in the hazard assessment of potential human contact sensitisers. The method was recommended in September 1998 by ICCVAM – USA (Interagency Co-ordination Committee for Validation of Alternative Methods) as a stand-alone alternative for contact sensitisation assessment.
The validity of the LLNA has been endorsed by EVCAM (European Centre for the Validation of Alternative Methods) on 21 March 2000 according to a statement adopted by ESAC (ECVAM Scientific Advisory Committee).
Today, the SCCNFP concluded that, based on the ICCVAM peer review document, the statement endorsed by ECVAM and based on its own opinion concerning the "Predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients" (SCCNFP/0120/99), the LLNA can be regarded as a recommended method for assessing the sensitisation potential of cosmetic ingredients.
However, the SCCNFP would stress that :
- the LLNA method is an alternative, not a replacement of the Guinea pig test method as it can not replace, at present, the current Guinea pig assay in all cases.
- the LLNA is a refinement test method, not a non-animal method. Refinement implies here that the method uses fewer animals and that the test is shorter. Therefore, based on ethical reasons, the LLNA should be the method of choice.
Document n° SCCNFP/0255/00, rev. 2 was adopted by the Committee. The method will be inserted in the Notes of Guidance.
Revision of the Notes of Guidance for the Testing of Cosmetic Ingredients for their Safety Evaluation, doc. n° SCCNFP/0321/00, May 2000
Prof. Loprieno reported on the changes made to the Notes of Guidance, as approved by the Working Party and presented today to the plenary meeting for adoption. He underlined that the revision is a continuous process : changes/updates ought to be made at the time new information becomes available and new annexes to be inserted following their adoption by the plenary meeting.
The document tabled today has been revised for linguistic corrections. Some chapters and annexes were updated and a new Annex 13 was inserted :
- Annex 2 - The Use of Methods Alternative to Animal studies : the opinion concerning the basic requirements for the testing of cosmetic ingredients for their safety evaluation (doc. n° SCCNFP/0308/00, adopted during the 11th plenary meeting of 17 February 2000) has been inserted.
- Annex 3 - Guidelines for the in vitro assessment of the photo-toxic potential of UV-filters : a series of modifications have been made concerning photo-mutagenicity.
- Annex 13 - The predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients : this is a new annex and relates to the opinion of the SCCNFP adopted during the 11th plenary meeting of 17 February 2000.
- Annex 14 – Classification of Substances : a new version of the classification system as adopted by the SCCNFP during the 11th plenary meeting of 17 February 2000.
Besides the changes to the Notes of Guidance, the rapporteur has drawn the attention of the committee to the remaining weak points in the Notes, namely :
(i) Annex 5 – General Scheme for Determining the Margin of Safety of Preservatives : crucial here are the exposure data. Industry is at present updating the figures and informed the Commission that the data will be submitted in the very near future. Upon receipt, the annex will be adapted accordingly.
(ii) Annex 7 – Guidelines for the Safety Assessment of the Finished Product : the revision of this annex requires a series of re-considerations and the input of expert(s) with in-depth experience in the issue. Beside pure scientific questions, the committee will be obliged to take the draft 7th Amendment to Council Directive 76/768/EEC into consideration. This draft focuses primarily on the prohibition of animal test performed on ingredients, on combination of ingredients and on finished products on the territory of the European Union.
Some members expressed their reservation to adopt the tabled version of Notes of Guidance as important issues regarding Annex 5 and 7 need to be solved first. Therefore, the SCCNFP said that they took notice of the changes to the Notes of Guidance presented today and invited the Working Party to initiate the necessary work on these annexes.
4.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that, as mentioned during the previous plenary meeting, the Working Party finalised draft opinions on hair dye n° C46 and on the use of 2,4-DPO in cosmetic hair care formulations. As it was not possible, due to further secretarial work, to present these documents during that plenary meeting, they are tabled now for formal adoption.
Regarding the work on the safety of amino acids derived from human hair hydrolysates with respect to TSE infectivity, he said that a copy of the dossier was sent to the Scientific Steering Committee for critical evaluation as the issue is of a multidisciplinary nature. This procedure ensures consistency with the various reports and opinions adopted so far on TSE inactivation processes and on specified risk material. An opinion of the SSC might be available by the end of May and will be complementary to the opinion of the SCCNFP.
Regarding the elucidations asked by the Austrian Delegation to the Committee on Adaptation to Technical Progress of the Annexes to the cosmetics Directive (CAPT, DG ENTR) on some recently adopted opinions on hair dyes, Prof. Andersen said that the draft answers to the questions concerning mutagenicity are now also available. The draft reply to the Austrian Delegation will be discussed during the next WP meeting of 24.5.00.
Finally, Prof. Andersen said that work will start soon – next WP meeting is on 24 May 2000 – to discuss 19 draft opinions, on which evaluation reports have been established.
Draft opinion on C46 – Basic Blue 7, doc n° SCCNFP/0241/99, rev. 1
Basic Blue 7 is intended to be used in hair tinting products at a maximum concentration of 0.2%.
The opinion was adopted with a classification 1 (may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in each case) subject to the labelling of cosmetic products containing this substance warning of a risk of sensitisation.
Draft opinion on 2,4-DPO, doc. n° SCCNFP/0215/99, rev. 1
2,4-DPO is used in cosmetic hair care formulations to prevent development of androgenic alopecia.
The SCCNFP approved the use of 2,4-DPO exclusively under the conditions of use stated in the safety file. As it is a new ingredient, it should be subjected to adequate surveillance of any side effects in consumers.
The opinion was adopted with a classification 1.
4.3 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that only one Working Party meeting was organised concerning the 1st update of the inventory since the last plenary meeting. During the morning session of this meeting, the members reviewed the various modifications discussed and agreed upon with COLIPA. Representatives of COLIPA were invited for the afternoon session.
As a result, a consensus was reached on the content of the 1st Update. The final draft 1st Update will be submitted by COLIPA on 10 June 2000 at the latest.
It was also agreed that, if all the corrections are incorporated in this final draft, it will be accepted without a second revision and addressed to the plenary meeting of 28 June 2000 for adoption.
Concerning section II – Perfume and aromatic raw materials - of the inventory, no information, in particular on the nature and identity of ingredients derived from botanicals, was received from industry. The Commission was asked to require from industry these data so that the necessary modifications can be incorporated in the 2nd update of the inventory.
4.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White reminded the plenary briefly about the on-going tasks :
* draft opinion on polycyclic musks : a meeting is foreseen on 14 June during which the issue will be discussed;
* draft opinion on ultra refined coal tar : also the work on this issue is in a final stage. The item is on the agenda of the WP meeting of 14 June.
* Letter from DG ENTR requesting clarifications on the opinion on teeth whitening products:
During the CATP meeting (Committee on the Adaptation to Technical Progress of the Annexes to Directive 76/768/EEC on cosmetic products) of 22 and 23 November 1999, the representatives of the Member States discussed, among others, the SCCNFP opinions (SCCNFP/0058/98 and SCCNFP/0200/99), concerning teeth whitening products containing hydrogen peroxide or carbamide peroxide in view of a possible inclusion in Annex III of the cosmetics directive. As a result of the discussion, most representatives of the Member States considered these products to be cosmetics. However, they could not be authorised as such, on the one hand, because they endanger the user's health and on the other hand, because of the restrictions that these products should only be used under the supervision of a dentist. As a consequence, the CATP strongly opposed the inclusion in Annex III of this type of products, as proposed by the Commission.
In order to regulate the issue, the SCCNFP answered the questions asked.
* Methyleugenol : it appeared that the data requested concerning methyleugenol has been available for quite some time but not yet submitted to the Committee. Therefore, the secretariat was asked to remind industry about this negligence. It was said that the opinion would be finalised without these data if not provided soon.
Draft opinion on Lithium hydroxide and Calcium hydroxide, doc. n° SCCNFP/0295/00, final
Annex III, part 1 to Directive 76/768/EEC on cosmetic products lists those substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.
Entries 15b and 15c stipulate the restrictions and conditions of use concerning Lithium hydroxide and Calcium hydroxide respectively.
However, these entries include at present the mention ‘Other uses' without an indication on limitations or requirements for use. Therefore, Member States required the Commission to specify the ‘Other uses' and to determine the restrictions and conditions of use.
In response to a letter from the Commission, industry specified that these chemicals are, apart from hair straightening products, mainly used as pH adjusters. A draft opinion concerning the modified entries in Annex III was prepared along these lines.
The SCCNFP adopted the opinion to extend entries 15b and 15c by the addition of a text in the column ‘field of application', in the column ‘maximum authorised concentration' and in the column ‘conditions of use and warning to be labelled.
Draft opinion concerning an initial list of perfumery materials which must not form part of fragrance compounds used in cosmetic products, doc. n° SCCNFP/0320/00
In the framework of their mandate on the safety of perfumery materials, the SCCNFP was asked, amongst others, if they could agree that all materials that IFRA recommends should not be used in fragrance compounds are included in Annex II - List of substances which must not form part of the composition of cosmetic products – to Directive 76/768/EEC on cosmetic products.
In the absence of specific regulations for fragrances, IFRA introduced self-regulatory disciplines for the industry, such as the IFRA list of prohibited fragrance ingredients. The list is based primarily on cutaneous safety concerns : the substances listed might provoke irritation and sensitisation reactions or photo-toxic effects. At present, 34 ingredients are listed.
This list was used as the basis for discussion. To the IFRA ‘prohibited' list, a series of other materials was added, namely the materials listed in the IFRA Code of Practice and defined as ‘materials not to be used as or in fragrance ingredients' or as ‘materials for which safe conditions of use have not been established (= absence of reports on their use as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from their use)'.
The draft opinion lists at present only those perfumery materials for which safety data are available. The opinion was therefore called ‘initial list of perfumery materials which must not form part of cosmetic products'. Doing so, other ingredients could be easily added as soon as their safety data become available.
The document was adopted by the plenary.
4.5 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the work of his Working Party was completely devoted to the use of Titanium dioxide in sun screen formulations. Submissions were received on micronised (< 50nm) and non-micronised (> 200 nm), on coated and un-coated material.
Still a series of points remain unclear.
Therefore, on 13 June 2000, a joint meeting is organised with the industry concerned to discuss the open questions :
* basic toxicology : does micronised TiO2 differ from non-micronised? Does the two crystal types (anastase, rutile) have different toxicity profiles?
* the mechanism of coating;
* the stability/photo-stability of the coating (i) under in-use conditions and (ii) if stored for a longer time.
* demonstration of the absence of photo-catalytic effects.
5. Consultation of the SCCNFP on the Commission Directive on the postponement of the animal testing ban
DG ENTR prepared a draft Commission Directive postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients in cosmetic products. Article 4.1 (i) of Directive 76/768/EEC on cosmetic products stipulates that ‘before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology'.
The Committee took notice of the draft directive and, as a result, decided to issue a favourable opinion.
In this context, the draft 7th Amendment of Directive 76/768/EEC was tabled for information.
The 7th Amendment focuses on the prohibition of animal tests on the territory of the European Union performed on ingredients of cosmetic products, on combinations of ingredients and on finished cosmetic products.
The Committee took notice of the draft Directive and decided to write a letter to Mr. Coleman, Director-General DG SANCO to express their great concern about the intention to completely ban the performance in the European Union of any animal experiments for cosmetics.
Although they support and acknowledge all plausible attempts and evaluation processes aiming at a replacement, refining or reducing (whole-)animal experiments, they could never agree to a judgement or evaluation of substances used in cosmetics which have not been investigated according to the actual valid methodologies and demands laid down in their ‘Notes of Guidance'.
6. Report of the Chairman
* White Paper on Food Safety : comments from the Scientific Steering Committee and from the Scientific Committee on Plants were tabled for information. Analogous to these papers, the SCCNFP requested Prof. Kemper, as the Chairman of the SCCNFP, to address to the Commission their comments on the White Paper with particular emphasis to the fact that they believe the safety of cosmetics form an integral part of public health and therefore may not be excluded from this future European Authority.
* Harmonisation of risk assessment : a progress report of the Scientific Steering Committee on the issue was tabled for information. The purpose of this paper is to create a framework on risk management applicable to all present/future scientific committees.
* DG Research Framework Program 5 – Cell Factory : a document assembling the research programs to be financed by the FP5. The document was tabled for information.
* Diethylphthalate : safety dossier received from industry. A draft opinion will be presented as soon as possible.
7. Any Other Business
* 24th and 25th Adaptation to Technical Progress : brief presentation by the representative of DG ENTR of these 2 directives which came into force.
* Further plenary meetings : 28 June 2000, 25 September 2000
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr R. Glomot, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr D. O'Mahony, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mrs L. Benali DG SANCO, Mrs S. Clarke DG SANCO, Mrs M. de Solà DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs A. Szklanna DG SANCO, Mr A. Van Elst DG SANCO
Annex 1
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 12th plenary meeting (Brussels, 3 May 2000)
1. Adoption of the agenda SCCNFP/0332/00
2. Declaration of interest
3. Approval of the minutes of the 11th plenary meeting of 17.2.00 SCCNFP/0307/00
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Draft opinion on the Murine Local Lymph Node Assay (LLNA) SCCNFP/0255/99
Revision of the Notes of Guidance SCCNFP/0321/00
4.2 Hair Dyes
Report of the Co-ordinator
Draft opinion on C46 SCCNFP/0241/00
Draft opinion on 2,4-DPO SCCNFP/0215/99
4.3 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on Lithium and Calcium hydroxide SCCNFP/0295/00
Draft opinion on an initial list of perfumery materials which must
not form part of cosmetic products SCCNFP/0320/00
4.4 Inventory
Report of the Co-ordinator
4.5 UV Filters
Report of the Co-ordinator
5. Consultation of the SCCNFP on the Commission Directive on SCCNFP/0335/00 the postponement of the animal testing ban
6. Report of the Chairman
7. Any other business
1. Adoption of the Agenda (doc. n° SCCNFP/0332/00) (Annex 1)
The agenda was adopted.
2. Declaration of interest
No interests were declared.
3. Approval of the minutes of the 11th plenary meeting of 17 February 2000, doc. n° SCCNFP/0307/00
The minutes were adopted, together with special thanks to the secretariat.
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Prof. Loprieno said that two documents were prepared by the Working Party and addressed to the plenary : the draft opinion on the Murine Local Lymph Node Assay (LLNA) and a revision of the Notes of Guidance.
In his report, Prof. Loprieno mentioned as well that the Working Party was informed about Guidelines DG ENTR is preparing for Small and Medium Size Enterprises (SME's) concerning the safety evaluation of cosmetics. He invited the Commission to present this document, as soon as it is finalised, to the SCCNFP for opinion.
Draft opinion on the Murine Local Lymph Node Assay (LLNA), doc. n° SCCNFP/0255/00 rev. 2
The Murine Local Lymph Node Assay is a test method which can be used in the hazard assessment of potential human contact sensitisers. The method was recommended in September 1998 by ICCVAM – USA (Interagency Co-ordination Committee for Validation of Alternative Methods) as a stand-alone alternative for contact sensitisation assessment.
The validity of the LLNA has been endorsed by EVCAM (European Centre for the Validation of Alternative Methods) on 21 March 2000 according to a statement adopted by ESAC (ECVAM Scientific Advisory Committee).
Today, the SCCNFP concluded that, based on the ICCVAM peer review document, the statement endorsed by ECVAM and based on its own opinion concerning the "Predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients" (SCCNFP/0120/99), the LLNA can be regarded as a recommended method for assessing the sensitisation potential of cosmetic ingredients.
However, the SCCNFP would stress that :
- the LLNA method is an alternative, not a replacement of the Guinea pig test method as it can not replace, at present, the current Guinea pig assay in all cases.
- the LLNA is a refinement test method, not a non-animal method. Refinement implies here that the method uses fewer animals and that the test is shorter. Therefore, based on ethical reasons, the LLNA should be the method of choice.
Document n° SCCNFP/0255/00, rev. 2 was adopted by the Committee. The method will be inserted in the Notes of Guidance.
Revision of the Notes of Guidance for the Testing of Cosmetic Ingredients for their Safety Evaluation, doc. n° SCCNFP/0321/00, May 2000
Prof. Loprieno reported on the changes made to the Notes of Guidance, as approved by the Working Party and presented today to the plenary meeting for adoption. He underlined that the revision is a continuous process : changes/updates ought to be made at the time new information becomes available and new annexes to be inserted following their adoption by the plenary meeting.
The document tabled today has been revised for linguistic corrections. Some chapters and annexes were updated and a new Annex 13 was inserted :
- Annex 2 - The Use of Methods Alternative to Animal studies : the opinion concerning the basic requirements for the testing of cosmetic ingredients for their safety evaluation (doc. n° SCCNFP/0308/00, adopted during the 11th plenary meeting of 17 February 2000) has been inserted.
- Annex 3 - Guidelines for the in vitro assessment of the photo-toxic potential of UV-filters : a series of modifications have been made concerning photo-mutagenicity.
- Annex 13 - The predictive testing of potentially cutaneous sensitising cosmetic ingredients or mixtures of ingredients : this is a new annex and relates to the opinion of the SCCNFP adopted during the 11th plenary meeting of 17 February 2000.
- Annex 14 – Classification of Substances : a new version of the classification system as adopted by the SCCNFP during the 11th plenary meeting of 17 February 2000.
Besides the changes to the Notes of Guidance, the rapporteur has drawn the attention of the committee to the remaining weak points in the Notes, namely :
(i) Annex 5 – General Scheme for Determining the Margin of Safety of Preservatives : crucial here are the exposure data. Industry is at present updating the figures and informed the Commission that the data will be submitted in the very near future. Upon receipt, the annex will be adapted accordingly.
(ii) Annex 7 – Guidelines for the Safety Assessment of the Finished Product : the revision of this annex requires a series of re-considerations and the input of expert(s) with in-depth experience in the issue. Beside pure scientific questions, the committee will be obliged to take the draft 7th Amendment to Council Directive 76/768/EEC into consideration. This draft focuses primarily on the prohibition of animal test performed on ingredients, on combination of ingredients and on finished products on the territory of the European Union.
Some members expressed their reservation to adopt the tabled version of Notes of Guidance as important issues regarding Annex 5 and 7 need to be solved first. Therefore, the SCCNFP said that they took notice of the changes to the Notes of Guidance presented today and invited the Working Party to initiate the necessary work on these annexes.
4.2 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that, as mentioned during the previous plenary meeting, the Working Party finalised draft opinions on hair dye n° C46 and on the use of 2,4-DPO in cosmetic hair care formulations. As it was not possible, due to further secretarial work, to present these documents during that plenary meeting, they are tabled now for formal adoption.
Regarding the work on the safety of amino acids derived from human hair hydrolysates with respect to TSE infectivity, he said that a copy of the dossier was sent to the Scientific Steering Committee for critical evaluation as the issue is of a multidisciplinary nature. This procedure ensures consistency with the various reports and opinions adopted so far on TSE inactivation processes and on specified risk material. An opinion of the SSC might be available by the end of May and will be complementary to the opinion of the SCCNFP.
Regarding the elucidations asked by the Austrian Delegation to the Committee on Adaptation to Technical Progress of the Annexes to the cosmetics Directive (CAPT, DG ENTR) on some recently adopted opinions on hair dyes, Prof. Andersen said that the draft answers to the questions concerning mutagenicity are now also available. The draft reply to the Austrian Delegation will be discussed during the next WP meeting of 24.5.00.
Finally, Prof. Andersen said that work will start soon – next WP meeting is on 24 May 2000 – to discuss 19 draft opinions, on which evaluation reports have been established.
Draft opinion on C46 – Basic Blue 7, doc n° SCCNFP/0241/99, rev. 1
Basic Blue 7 is intended to be used in hair tinting products at a maximum concentration of 0.2%.
The opinion was adopted with a classification 1 (may be used in cosmetic products for the designated purposes and in concentrations not exceeding the limits indicated in each case) subject to the labelling of cosmetic products containing this substance warning of a risk of sensitisation.
Draft opinion on 2,4-DPO, doc. n° SCCNFP/0215/99, rev. 1
2,4-DPO is used in cosmetic hair care formulations to prevent development of androgenic alopecia.
The SCCNFP approved the use of 2,4-DPO exclusively under the conditions of use stated in the safety file. As it is a new ingredient, it should be subjected to adequate surveillance of any side effects in consumers.
The opinion was adopted with a classification 1.
4.3 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that only one Working Party meeting was organised concerning the 1st update of the inventory since the last plenary meeting. During the morning session of this meeting, the members reviewed the various modifications discussed and agreed upon with COLIPA. Representatives of COLIPA were invited for the afternoon session.
As a result, a consensus was reached on the content of the 1st Update. The final draft 1st Update will be submitted by COLIPA on 10 June 2000 at the latest.
It was also agreed that, if all the corrections are incorporated in this final draft, it will be accepted without a second revision and addressed to the plenary meeting of 28 June 2000 for adoption.
Concerning section II – Perfume and aromatic raw materials - of the inventory, no information, in particular on the nature and identity of ingredients derived from botanicals, was received from industry. The Commission was asked to require from industry these data so that the necessary modifications can be incorporated in the 2nd update of the inventory.
4.4 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White reminded the plenary briefly about the on-going tasks :
* draft opinion on polycyclic musks : a meeting is foreseen on 14 June during which the issue will be discussed;
* draft opinion on ultra refined coal tar : also the work on this issue is in a final stage. The item is on the agenda of the WP meeting of 14 June.
* Letter from DG ENTR requesting clarifications on the opinion on teeth whitening products:
During the CATP meeting (Committee on the Adaptation to Technical Progress of the Annexes to Directive 76/768/EEC on cosmetic products) of 22 and 23 November 1999, the representatives of the Member States discussed, among others, the SCCNFP opinions (SCCNFP/0058/98 and SCCNFP/0200/99), concerning teeth whitening products containing hydrogen peroxide or carbamide peroxide in view of a possible inclusion in Annex III of the cosmetics directive. As a result of the discussion, most representatives of the Member States considered these products to be cosmetics. However, they could not be authorised as such, on the one hand, because they endanger the user's health and on the other hand, because of the restrictions that these products should only be used under the supervision of a dentist. As a consequence, the CATP strongly opposed the inclusion in Annex III of this type of products, as proposed by the Commission.
In order to regulate the issue, the SCCNFP answered the questions asked.
* Methyleugenol : it appeared that the data requested concerning methyleugenol has been available for quite some time but not yet submitted to the Committee. Therefore, the secretariat was asked to remind industry about this negligence. It was said that the opinion would be finalised without these data if not provided soon.
Draft opinion on Lithium hydroxide and Calcium hydroxide, doc. n° SCCNFP/0295/00, final
Annex III, part 1 to Directive 76/768/EEC on cosmetic products lists those substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.
Entries 15b and 15c stipulate the restrictions and conditions of use concerning Lithium hydroxide and Calcium hydroxide respectively.
However, these entries include at present the mention ‘Other uses' without an indication on limitations or requirements for use. Therefore, Member States required the Commission to specify the ‘Other uses' and to determine the restrictions and conditions of use.
In response to a letter from the Commission, industry specified that these chemicals are, apart from hair straightening products, mainly used as pH adjusters. A draft opinion concerning the modified entries in Annex III was prepared along these lines.
The SCCNFP adopted the opinion to extend entries 15b and 15c by the addition of a text in the column ‘field of application', in the column ‘maximum authorised concentration' and in the column ‘conditions of use and warning to be labelled.
Draft opinion concerning an initial list of perfumery materials which must not form part of fragrance compounds used in cosmetic products, doc. n° SCCNFP/0320/00
In the framework of their mandate on the safety of perfumery materials, the SCCNFP was asked, amongst others, if they could agree that all materials that IFRA recommends should not be used in fragrance compounds are included in Annex II - List of substances which must not form part of the composition of cosmetic products – to Directive 76/768/EEC on cosmetic products.
In the absence of specific regulations for fragrances, IFRA introduced self-regulatory disciplines for the industry, such as the IFRA list of prohibited fragrance ingredients. The list is based primarily on cutaneous safety concerns : the substances listed might provoke irritation and sensitisation reactions or photo-toxic effects. At present, 34 ingredients are listed.
This list was used as the basis for discussion. To the IFRA ‘prohibited' list, a series of other materials was added, namely the materials listed in the IFRA Code of Practice and defined as ‘materials not to be used as or in fragrance ingredients' or as ‘materials for which safe conditions of use have not been established (= absence of reports on their use as fragrance ingredient and/or inadequate evaluation of potential adverse effects resulting from their use)'.
The draft opinion lists at present only those perfumery materials for which safety data are available. The opinion was therefore called ‘initial list of perfumery materials which must not form part of cosmetic products'. Doing so, other ingredients could be easily added as soon as their safety data become available.
The document was adopted by the plenary.
4.5 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the work of his Working Party was completely devoted to the use of Titanium dioxide in sun screen formulations. Submissions were received on micronised (< 50nm) and non-micronised (> 200 nm), on coated and un-coated material.
Still a series of points remain unclear.
Therefore, on 13 June 2000, a joint meeting is organised with the industry concerned to discuss the open questions :
* basic toxicology : does micronised TiO2 differ from non-micronised? Does the two crystal types (anastase, rutile) have different toxicity profiles?
* the mechanism of coating;
* the stability/photo-stability of the coating (i) under in-use conditions and (ii) if stored for a longer time.
* demonstration of the absence of photo-catalytic effects.
5. Consultation of the SCCNFP on the Commission Directive on the postponement of the animal testing ban
DG ENTR prepared a draft Commission Directive postponing for a second time the date after which animal tests are prohibited for ingredients or combinations of ingredients in cosmetic products. Article 4.1 (i) of Directive 76/768/EEC on cosmetic products stipulates that ‘before submitting such measures, the Commission will consult the Scientific Committee on Cosmetology'.
The Committee took notice of the draft directive and, as a result, decided to issue a favourable opinion.
In this context, the draft 7th Amendment of Directive 76/768/EEC was tabled for information.
The 7th Amendment focuses on the prohibition of animal tests on the territory of the European Union performed on ingredients of cosmetic products, on combinations of ingredients and on finished cosmetic products.
The Committee took notice of the draft Directive and decided to write a letter to Mr. Coleman, Director-General DG SANCO to express their great concern about the intention to completely ban the performance in the European Union of any animal experiments for cosmetics.
Although they support and acknowledge all plausible attempts and evaluation processes aiming at a replacement, refining or reducing (whole-)animal experiments, they could never agree to a judgement or evaluation of substances used in cosmetics which have not been investigated according to the actual valid methodologies and demands laid down in their ‘Notes of Guidance'.
6. Report of the Chairman
* White Paper on Food Safety : comments from the Scientific Steering Committee and from the Scientific Committee on Plants were tabled for information. Analogous to these papers, the SCCNFP requested Prof. Kemper, as the Chairman of the SCCNFP, to address to the Commission their comments on the White Paper with particular emphasis to the fact that they believe the safety of cosmetics form an integral part of public health and therefore may not be excluded from this future European Authority.
* Harmonisation of risk assessment : a progress report of the Scientific Steering Committee on the issue was tabled for information. The purpose of this paper is to create a framework on risk management applicable to all present/future scientific committees.
* DG Research Framework Program 5 – Cell Factory : a document assembling the research programs to be financed by the FP5. The document was tabled for information.
* Diethylphthalate : safety dossier received from industry. A draft opinion will be presented as soon as possible.
7. Any Other Business
* 24th and 25th Adaptation to Technical Progress : brief presentation by the representative of DG ENTR of these 2 directives which came into force.
* Further plenary meetings : 28 June 2000, 25 September 2000
Attendance List
Present : Mr K.E. Andersen, Mr R. Anton, Mr J-F. Doré, Mr P. Elsner, Mr R. Glomot, Mr V. Kapoulas, Mr F. Kemper, Mr B. Lina, Mr N. Loprieno, Mr J. Parra, Mr D. O'Mahony, Mrs V. Rogiers, Mr T. Sanner, Mr J. Vives Rego, Mr I. White
Commission : Mrs L. Benali DG SANCO, Mrs S. Clarke DG SANCO, Mrs M. de Solà DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs A. Szklanna DG SANCO, Mr A. Van Elst DG SANCO
Annex 1
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 12th plenary meeting (Brussels, 3 May 2000)
1. Adoption of the agenda SCCNFP/0332/00
2. Declaration of interest
3. Approval of the minutes of the 11th plenary meeting of 17.2.00 SCCNFP/0307/00
4. SCCNFP - Specific Working Parties
4.1 Alternatives
Report of the Co-ordinator
Draft opinion on the Murine Local Lymph Node Assay (LLNA) SCCNFP/0255/99
Revision of the Notes of Guidance SCCNFP/0321/00
4.2 Hair Dyes
Report of the Co-ordinator
Draft opinion on C46 SCCNFP/0241/00
Draft opinion on 2,4-DPO SCCNFP/0215/99
4.3 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on Lithium and Calcium hydroxide SCCNFP/0295/00
Draft opinion on an initial list of perfumery materials which must
not form part of cosmetic products SCCNFP/0320/00
4.4 Inventory
Report of the Co-ordinator
4.5 UV Filters
Report of the Co-ordinator
5. Consultation of the SCCNFP on the Commission Directive on SCCNFP/0335/00 the postponement of the animal testing ban
6. Report of the Chairman
7. Any other business
