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Directorate-General for Health and Food Safety
Prof. Kemper, the chairman of the SCCNFP,
welcomed all participants.
He said that the today's meeting was the last one under the present mandate. He thanked all the members and the external experts for their commitment : more than 100 opinions have been adopted during this mandate. He also thanked Mrs M. de Solà, Head of Unit and her staff for their precious support.
From their part, the members, the external experts and the Commission thanked Prof. Kemper and expressed their appreciation of the way he had chaired the Committee.
Mrs de Solà informed the meeting about the renewal of the 8 sectorial scientific committees : the lists of proposed new members have been sent for inter-service consultation. This means that the DG's concerned may comment within 10 working days. Subsequently, the lists will be sent to the Commission, who will decide by written procedure. She said a decision is expected before the end of November.
1. Adoption of the Agenda (doc. n° SCCNFP/0422/00) (in annex)
The agenda was adopted.
2. Detergents in cosmetic and household products, Safety and Health related aspects
Dr. A.-M. Rodeyns, Dr. R. Roggeband, AISE
Prof. Kemper reminded the members that a Working Party was set up further to a concern about possible health effects related to the use of detergents and other household cleaning products.
In this framework, Dr. A.-M. Rodeyns and Dr. R. Roggeband, representing the Association Internationale de la Savonnerie, de la Détergence et des Produits d'Entretien (AISE) were invited to discuss the health and safety related aspects concerning the use of detergents in cosmetics and household products.
The presentation was followed by a discussion which focused, besides legal aspects, mainly on general information concerning the detergents and cleaning products industry and on risk assessment procedures.
3. Declaration of interest
None of the Members declared an interest that could prevent her/him from participating in the discussion of any of the items on the agenda.
4. Approval of the minutes of the 13th plenary meeting of 28 June 2000, doc. n° SCCNFP/0388/00
The minutes were adopted, together with special thanks to the secretariat.
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno recapitulated the work done during the present mandate (1997-2000), and in particular the follow-up of the development and the validation of alternative methods to the use of animals in the field of cosmetic safety evaluation according to the requirements of the cosmetics directive.
He said that a series of documents have been adopted by the SCCNFP concerning the use of alternative methods and concerning the use of human volunteers in the safety evaluation of cosmetic ingredients/mixture of ingredients and finished products, providing the cosmetic industry with scientific recommendations/basic scientific criteria. All these documents have been included in SCCNFP's basic document, namely the ‘Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation' (last updated SCCNFP/0321/00, Oct 24, 2000).
Concerning Annex 5 ‘General Scheme for Determining the Margin of Safety of Preservatives' to the Notes of Guidance, Prof. Loprieno said that the exposure levels to cosmetics, as recently submitted by industry, vary considerably among the various Member States. Therefore, and in the absence of reliable exposure data, it was proposed to use the highest quantity of the cosmetic product used per application for the evaluation of the Margin of Safety. The issue will be further discussed.
Finally, Prof. Loprieno said that he has the privilege to propose to the before long renewed Committee a series of issues, such as the safety of so called ‘natural cosmetics', evaluation criteria for the metabolism of cosmetic ingredients in human skin, or the need for a well organised cosmetic surveillance as requested by the sixth amendment, for consideration.
Revision of Annex 7 of the ‘Notes of Guidance' on ‘Guidelines for the Safety Assessment of the Finished Cosmetic Product', doc. n° SCCNFP/0363/00, rev. 3
Although the safety evaluation of finished cosmetic products falls outside the field of competence of the SCCNFP, guidelines for the safety assessment of finished cosmetic products (Annex 7) have been elaborated. Therefore, the proposed scheme for a technical information file should not be used as a check list but be taken into consideration and adapted on a case by case basis.
The content of the main section of Annex 7 has not been modified, its presentation, however, was made more readable.
Points were inserted (i) on the physico-chemical and micro-biological specifications of cosmetic ingredients, (ii) on the stability and on the physico-chemical and microbiological specifications of finished products and (iii) on the regular review of the safety of the finished products.
Concerning the toxicological profile of the ingredient it was stressed that the data sources should be clearly indicated and that the toxicological data given should be derived from test performed with exactly the same substance(s) as that (those) included in the finished product.
As regards fragrances, the Committee proposed that the certificate of conformity should be supplemented by additional information and that reference should be made in the assessment to the semi-quantitative formulation of the fragrance compound and data on the toxic potential of the ingredients singularly or in combination and with relevance to the finished product considered as a whole.
The revision of Annex 7 was adopted by the SCCNFP and will replace the present version.
Report on percutaneous absorption of hair dyes, doc. n° SCCNFP/0426/00
Industry has demonstrated that the evaluation of the same experimental data on percutaneous absorption can lead to considerably different conclusions depending of the calculation model used (based on flux calculation or on percentage of skin absorption). These findings were submitted to the SCCNFP for consideration/clarification : there might be need to adapt the protocol on percutaneous absorption in Annex 10 of the Notes of Guidance.
The SCCNFP studied the questions asked and concluded that their calculation models proposed and the derived percutaneous absorption figures were incorrect. However, small changes will be made to Annex 10 in order to clarify the terminology used.
The document was adopted by the SCCNFP. The proposed changes will be made to Annex 10.
Revision of the Notes of Guidance for testing of cosmetic ingredients for the safety evaluation, doc. n° SCCNFP/0321/00, rev. 18.10.2000-10-27
Since the adoption of the last version of the Notes of Guidance during the 8th plenary meeting of 23 June 1999, a series of revisions have been adopted by the SCCNFP. All have been included in this version.
Prof. Loprieno said that the present update reflects the work done during the committee's mandate 1997-2000 and represents a valuable piece of information for the industry and public authorities.
The document was adopted by the SCCNFP.
5.2 Detergents
Report of the Co-ordinator
In his report, Prof. Vives Rego said that, because this WP was set up only recently, only 2 WP-meetings took place during the present mandate. He reminded the meeting that the WP was set up further to a concern about possible health effects related to the use of detergents, household or similar products, an issue raised by members of the SCCNFP.
He presented the memorandum prepared by the WP. This memorandum highlights the objectives, priority tasks of the WP as well as other points of concern. Annexed to this memorandum is a document ‘Detergents – the dermatologist's view', which advocates the assessment of the risks to the consumer by the use of these products.
5.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that since the previous plenary meeting of 28 June 2000, only 1 WP meeting took place during which 10 draft opinions were discussed. For all these drafts, additional data were requested from industry. Their evaluation will resume upon receipt of this data.
To recapitulate the work done during this mandate, he said that :
i) 35 hair dye opinions have been adopted. All these substances were classified 1 under the specified conditions of use;
ii) 30 hair dyes dossier were evaluated but additional data were requested from industry;
iii) 21 dossiers are pending. Industry said they are still interested in these substances and will submit safety files as soon as possible.
Although the frequency of reported side effects from the use of hair dyes is low and appears not to increase in spite of an increased use of hair dyeing products, Prof. Andersen repeated his request to industry to supply public certified laboratories with samples of hair dye ingredients for chemical analysis. Such an analysis is regarded as an important tool for public control measures of these substances.
5.4 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that, further to the adoption of an opinion on the 1st update of section I – Inventory of cosmetic ingredients - of the inventory during the 13th plenary meeting of 28 June 2000, the Working Party concluded also their work on the first update of Section II – Perfume and aromatic raw materials - of the inventory. A draft opinion in this respect was tabled for formal adoption.
Draft opinion on the 1st update of Section II of the inventory, doc. n° SCCNFP/0389/00
Analogous to the opinion on the 1st update of Section I, also this draft opinion on the 1st update of Section II of the inventory has been prepared according to the provisions of the cosmetics directive concerning the role of the inventory, namely being, amongst others, ‘a tool of transparency'.
In order to fulfil this task, the SCCNFP met experts from the European Fragrance Industry and worked in collaboration with the Joint Research Centre of the European Commission.
Where the original list tabulated the entries by their EINECS number and thus did not permit the ready identification of fragrance ingredient by its commonly known trivial name predominating in scientific literature or textbooks, this 1st update tabulates the fragrance and aromatic raw materials in alphabetic order.
About 310 new entries have been added. Their total number is now about 2750. The improvements made to the original version of section II concerns mainly the botanical's entries. However, as the inventory is an evolving document, the SCCNFP proposes already in its opinion a series of approaches as recommendations for future updates.
The draft opinions (i) on the 1st update of Section II of the inventory, doc. n° SCCNFP/0389/00,
(ii) on the introduction to the 1st update of the inventory of cosmetic ingredients, Section II, doc. n° SCCNFP/0399/00, (iii) on the finalisation of botanical's entries to the inventory of Section II, doc. n° SCCNFP/0148/00 and (iv) on the revision of the 1st update of the inventory, Section II, doc. n° SCCNFP/0430/00 have been adopted by the SCCNFP, subject to some modifications of documents SCCNFP/0399/00 and SCCNFP/0430/00.
The SCCNFP especially acknowledged the co-operation with EFFA and its scientific experts in establishing the 1st update of section II of the inventory.
5.5 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White recapitulated briefly the issues discussed since the last plenary meeting :
- fragrances : analogous to the opinion adopted during the 12th plenary meeting of 3 May 2000 on ‘not-to-be-used' fragrance materials, the WP initiated the evaluation of the IFRA restricted fragrance ingredients in view of their proposed inclusion in Annex III, Part 1 - List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down - to Directive 76/768/EEC on cosmetic products. The entries were considered and their ‘suitability' to be on the list was cross-checked with the respective monographs, if available.
- alpha-Hydroxy acids : following the publication of the position paper concerning the safety of AHA's on the internet, 15 comments on the position paper were received, nearly exclusively from industry and national institutes. The WP considered each of the comments and found that (i) the national institutes and the consumer associations could agree with the proposed limitations (ii) industry refers to the same basic data/studies. The comments referring to the therapeutic use fall outside the scope of the issue. The WP concluded that the main points of concern remain unanswered
An open discussion with industry was organised. However, and despite the size of the documentation, the answers were not forthcoming. Therefore industry agreed to do a number of additional experiments (evaluations of the percutaneous absorption, skin barrier integrity and photo-sensitivity) with particular emphasis on the worst case situations and to present the draft protocols of these tests to the Committee for approval.
- enzymes : an issue to be considered by the renewed committee with respect to their possible effects to the skin.
Draft opinion on AHTN, doc. n° SCCNFP/0372/00, final draft
As decided during the plenary meeting of 28 June 2000, the WP re-evaluated the oral and dermal sub-chronic toxicity studies. The reason to do so was the coloration of a series of organs/glands due to the administration of AHTN. Even after the re-evaluation of these studies and the subsequent discussion, it was not clear where the coloration came from and whether the coloration and the toxic effects noted were related or not.
Secondly, the oral study did not reveal a NOEL. Although the effects observed at the low dose level were only slight and of questionable relevance, they were dose-related, consistent or present in both sexes (triglycerides). However, an oral MEL of 5 mg/kg/bw could be assumed and retained as the NOAEL for the calculation of the Margin Of Safety.
The opinion was adopted by the SCCNFP, subject to the following conditions :
* information on the purity of the substance should be provided;
* a new in vitro penetration study has to be provided in accordance with the SCCNFP Notes of Guidance;
* the absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
* in its final statement, the SCCNFP will take into consideration the results of the investigation and characterisation of the coloration of the internal organs in rats (announced in Submission 6).
The above has been formulated only on review of the cosmetic use of AHTN. For the full safety assessment of AHTN, it is necessary to consider as well all other sources of consumer exposure e.g., laundry products.
Classification : 3 and 12 months to deliver requested studies.
Draft opinion on HHCB, doc. n° SCCNFP/0403/00, final draft
Similar things were said concerning HHCB. However, the effects seen were less ‘expressed'.
The opinion was adopted by the SCCNFP, subject to the following condition :
* information on the purity of the substance and its possible isomers should be provided;
* a new in vitro penetration study has to be provided in accordance with the SCCNFP Notes of Guidance;
* the absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
The above has been formulated only on review of the cosmetic use of HHCB. For the full safety assessment of HHCB, it is necessary to consider as well all other sources of consumer exposure e.g., laundry products.
Classification : 3 and 12 months to deliver requested studies.
Draft opinion on Methyleugenol, doc. n° SCCNFP/0373/00, final draft
Further to a IFRA recommendation to cease all use of Methyleugenol due to the fact that it recently has been identified as a genotoxic carcinogen, the SCCNFP has been asked to examine the safety of methyleugenol in order to determine whether it should be placed in Annex II – ‘List of substances which must not form part of the composition of cosmetic products' - of the cosmetics Directive 76/768/EEC.
Whilst methyleugenol is not added directly to cosmetic products, but rather it features as a component of fragrances, such materials have been reviewed previously (e.g. musks) and it is thought appropriate that the use of the material should be prohibited if it poses a health risk.
As a result, the SCCNFP concluded that methyleugenol should not be intentionally added as an ingredient in cosmetic products. However, for a fragrance compound containing methyleugenol naturally present in essential oils, the concentration of methyleugenol should not exceed 0.05% in the fragrance compound. This means that, based on highest exposure, the concentration of methyleugenol in the finished cosmetic product may not exceed 0.01% in a fine fragrance, 0.004 % in eau de toilette, 0.002 % in a fragrance cream, 0.0002 % in other leave-on products and in oral hygiene products, and 0.001% in rinse-off products.
The opinion was adopted by the SCCNFP. Classification 1 for the intended use.
Draft opinion on Oakmoss/Treemoss extracts and appropriate consumer information, doc. n° SCCNFP/0421/00, final draft
This draft opinion enters in the framework of the mandate concerning the safety review of fragrance materials, and in particular concerning appropriate consumer information regarding fragrance allergens. As stipulated in its opinion on fragrance allergy in consumers, opinion adopted during the 10th plenary meeting of 8 December 1999, the SCCNFP said that natural products, such as oakmoss/treemoss should be considered in a separate document.
Most oakmoss extracts are actually mixtures of oakmoss and treemoss extracts and although the main allergens in these extracts have not yet been identified, several candidates exist. Since these extracts are derived from natural products, considerable batch to batch variations are found.
On review of the information presently available, the SCCNFP concluded that oakmoss/treemoss extracts have a well recognised potential to cause allergic reaction in the consumer. In accordance with the above mentioned opinion on fragrance allergy in consumers, appropriate information should be provided to the consumer regarding the presence of oakmoss/treemoss extracts in cosmetic products.
In response to the question asked by the representative of DG ENTR on what exactly should be understood by appropriate consumer information, the Committee said that labelling clearly is the best way to make the consumer aware of the presence of these extracts in cosmetic products. However, labelling is a ‘risk management'-tool, an issue which falls outside the field of competence of the Scientific Committees.
The opinion was adopted by the SCCNFP.
5.6 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the safety assessment of Titanium dioxide, coated/uncoated, for use as an UV filter has been finalised and that a draft opinion was tabled for adoption.
Draft opinion on Titanium dioxide (S75), doc. n° SCCNFP/0005/98
The Committee was requested to consider the safety profile of titanium dioxide to be sufficient to permit its listing in part I of Annex VII – ‘List of UV filters which cosmetic products may contain'- to the cosmetic directive 76/768/EEC.
In its opinion, the committee evaluated the safety of crystalline titanium dioxide, whether or not subjected to various treatments (coating, doping, etc.), and irrespective of its particle size.
As a result, the committee concluded that titanium dioxide is safe for use in sun screen formulations at a maximum concentration of 25% provided that the above mentioned treatments (doping, coating, etc.) do not compromise the safety of the product.
The opinion was adopted by the SCCNFP. Classification 1 at a maximum concentration of 25%.
6. Report of the Chairman
* TAIEX-conference, Bulgaria : Prof. Kemper informed the committee about a presentation he gave on the work of the SCCNFP during the TAIEX conference, a Commission initiative towards candidate Member States.
7. Any Other Business
* 26th adaptation : Dr. Norgaard informed the committee about the outcome of the Ad Hoc Working Party meeting with the Member States concerning the draft 26th adaptation to technical progress of the annexes to the cosmetics directive.
* New mandates : mandates were received requesting the safety review of (i) certain azo-dyes, (ii) 3-Iodo-2-propynyl butylcarbamate, (iii) tea tree oil, (iv) alpha-Tocopherol acetate, (v) dialkanolamines, (vi) methylene chloride alone and in a mixture with 1,1,1-Trichloroethane, (vi) GM cotton, and on (vii) benzoyl peroxide, hydroquinone and hydroquinone methylether.
Prof. Kemper said he will look into the respective files and assign the rapporteurs.
* Further plenary meetings : the date of the first meeting of the renewed committee will be communicated as soon as possible.
Attendance List
Present : Mr K.E. Andersen, Mr N. Loprieno, Mr R. Anton, Mr J. Parra, Mr J-F. Doré, Mr D. O'Mahony, Mr P. Elsner, Mrs V. Rogiers, Mr R. Glomot, Mr T. Sanner, Mr V. Kapoulas, Mr J. Vives Rego, Mr F. Kemper, Mr I. White, Mr B. Lina
External experts : Mr Ph. Masson, Mrs R. Schumann
Commission : Mrs L. Benali DG SANCO, Mrs M. de Solà DG SANCO, Mrs S. Clarke DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs S. Bernal DG SANCO, Mr A. Van Elst DG SANCO
Annex
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 14th plenary meeting (Brussels, 24 October 2000)
1. Adoption of the agenda
2. Detergents in cosmetic and household products, Safety and Health related aspects
Dr. A.-M. Rodeyns, Dr. R. Roggeband, AISE
3. Declaration of interest
4. Approval of the minutes of the 13th plenary meeting of 28.6.00
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
Revision of the Notes of Guidance of Guidance for testing of cosmetic ingredients for their safety evaluation
Report on percutaneous absorption of hair dyes
Revision of the Annex 7 of the Notes of Guidance "Guidelines for the safety assessment of the finished cosmetic product"
Understanding of the principles of safety evaluation of finished cosmetic products (for information)
5.2 Detergents
Report of the Co-ordinator
5.3 Hair Dyes
Report of the Co-ordinator
5.4 Inventory
Report of the Co-ordinator
Draft opinion on the 1st Update of Section II – Perfume and Aromatic Raw Materials - of the inventory
Introduction to the 1st update of Section II of the Inventory
Finalisation of the botanical-entries to Section II of the Inventory
Revision of the 1st update of Section II of the Inventory
5.5 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on AHTN
Draft opinion on HHCB
Draft opinion on Methyleugenol
Draft opinion on Oak moss/Tree moss
5.6 UV Filters
Report of the Co-ordinator
Draft opinion on Titanium dioxide (S75)
6. Report of the Chairman
7. Any other business
* Mandates received
* Future meetings
He said that the today's meeting was the last one under the present mandate. He thanked all the members and the external experts for their commitment : more than 100 opinions have been adopted during this mandate. He also thanked Mrs M. de Solà, Head of Unit and her staff for their precious support.
From their part, the members, the external experts and the Commission thanked Prof. Kemper and expressed their appreciation of the way he had chaired the Committee.
Mrs de Solà informed the meeting about the renewal of the 8 sectorial scientific committees : the lists of proposed new members have been sent for inter-service consultation. This means that the DG's concerned may comment within 10 working days. Subsequently, the lists will be sent to the Commission, who will decide by written procedure. She said a decision is expected before the end of November.
1. Adoption of the Agenda (doc. n° SCCNFP/0422/00) (in annex)
The agenda was adopted.
2. Detergents in cosmetic and household products, Safety and Health related aspects
Dr. A.-M. Rodeyns, Dr. R. Roggeband, AISE
Prof. Kemper reminded the members that a Working Party was set up further to a concern about possible health effects related to the use of detergents and other household cleaning products.
In this framework, Dr. A.-M. Rodeyns and Dr. R. Roggeband, representing the Association Internationale de la Savonnerie, de la Détergence et des Produits d'Entretien (AISE) were invited to discuss the health and safety related aspects concerning the use of detergents in cosmetics and household products.
The presentation was followed by a discussion which focused, besides legal aspects, mainly on general information concerning the detergents and cleaning products industry and on risk assessment procedures.
3. Declaration of interest
None of the Members declared an interest that could prevent her/him from participating in the discussion of any of the items on the agenda.
4. Approval of the minutes of the 13th plenary meeting of 28 June 2000, doc. n° SCCNFP/0388/00
The minutes were adopted, together with special thanks to the secretariat.
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
In his report, Prof. Loprieno recapitulated the work done during the present mandate (1997-2000), and in particular the follow-up of the development and the validation of alternative methods to the use of animals in the field of cosmetic safety evaluation according to the requirements of the cosmetics directive.
He said that a series of documents have been adopted by the SCCNFP concerning the use of alternative methods and concerning the use of human volunteers in the safety evaluation of cosmetic ingredients/mixture of ingredients and finished products, providing the cosmetic industry with scientific recommendations/basic scientific criteria. All these documents have been included in SCCNFP's basic document, namely the ‘Notes of Guidance for Testing of Cosmetic Ingredients for Their Safety Evaluation' (last updated SCCNFP/0321/00, Oct 24, 2000).
Concerning Annex 5 ‘General Scheme for Determining the Margin of Safety of Preservatives' to the Notes of Guidance, Prof. Loprieno said that the exposure levels to cosmetics, as recently submitted by industry, vary considerably among the various Member States. Therefore, and in the absence of reliable exposure data, it was proposed to use the highest quantity of the cosmetic product used per application for the evaluation of the Margin of Safety. The issue will be further discussed.
Finally, Prof. Loprieno said that he has the privilege to propose to the before long renewed Committee a series of issues, such as the safety of so called ‘natural cosmetics', evaluation criteria for the metabolism of cosmetic ingredients in human skin, or the need for a well organised cosmetic surveillance as requested by the sixth amendment, for consideration.
Revision of Annex 7 of the ‘Notes of Guidance' on ‘Guidelines for the Safety Assessment of the Finished Cosmetic Product', doc. n° SCCNFP/0363/00, rev. 3
Although the safety evaluation of finished cosmetic products falls outside the field of competence of the SCCNFP, guidelines for the safety assessment of finished cosmetic products (Annex 7) have been elaborated. Therefore, the proposed scheme for a technical information file should not be used as a check list but be taken into consideration and adapted on a case by case basis.
The content of the main section of Annex 7 has not been modified, its presentation, however, was made more readable.
Points were inserted (i) on the physico-chemical and micro-biological specifications of cosmetic ingredients, (ii) on the stability and on the physico-chemical and microbiological specifications of finished products and (iii) on the regular review of the safety of the finished products.
Concerning the toxicological profile of the ingredient it was stressed that the data sources should be clearly indicated and that the toxicological data given should be derived from test performed with exactly the same substance(s) as that (those) included in the finished product.
As regards fragrances, the Committee proposed that the certificate of conformity should be supplemented by additional information and that reference should be made in the assessment to the semi-quantitative formulation of the fragrance compound and data on the toxic potential of the ingredients singularly or in combination and with relevance to the finished product considered as a whole.
The revision of Annex 7 was adopted by the SCCNFP and will replace the present version.
Report on percutaneous absorption of hair dyes, doc. n° SCCNFP/0426/00
Industry has demonstrated that the evaluation of the same experimental data on percutaneous absorption can lead to considerably different conclusions depending of the calculation model used (based on flux calculation or on percentage of skin absorption). These findings were submitted to the SCCNFP for consideration/clarification : there might be need to adapt the protocol on percutaneous absorption in Annex 10 of the Notes of Guidance.
The SCCNFP studied the questions asked and concluded that their calculation models proposed and the derived percutaneous absorption figures were incorrect. However, small changes will be made to Annex 10 in order to clarify the terminology used.
The document was adopted by the SCCNFP. The proposed changes will be made to Annex 10.
Revision of the Notes of Guidance for testing of cosmetic ingredients for the safety evaluation, doc. n° SCCNFP/0321/00, rev. 18.10.2000-10-27
Since the adoption of the last version of the Notes of Guidance during the 8th plenary meeting of 23 June 1999, a series of revisions have been adopted by the SCCNFP. All have been included in this version.
Prof. Loprieno said that the present update reflects the work done during the committee's mandate 1997-2000 and represents a valuable piece of information for the industry and public authorities.
The document was adopted by the SCCNFP.
5.2 Detergents
Report of the Co-ordinator
In his report, Prof. Vives Rego said that, because this WP was set up only recently, only 2 WP-meetings took place during the present mandate. He reminded the meeting that the WP was set up further to a concern about possible health effects related to the use of detergents, household or similar products, an issue raised by members of the SCCNFP.
He presented the memorandum prepared by the WP. This memorandum highlights the objectives, priority tasks of the WP as well as other points of concern. Annexed to this memorandum is a document ‘Detergents – the dermatologist's view', which advocates the assessment of the risks to the consumer by the use of these products.
5.3 Hair Dyes
Report of the Co-ordinator
In his report, Prof. Andersen said that since the previous plenary meeting of 28 June 2000, only 1 WP meeting took place during which 10 draft opinions were discussed. For all these drafts, additional data were requested from industry. Their evaluation will resume upon receipt of this data.
To recapitulate the work done during this mandate, he said that :
i) 35 hair dye opinions have been adopted. All these substances were classified 1 under the specified conditions of use;
ii) 30 hair dyes dossier were evaluated but additional data were requested from industry;
iii) 21 dossiers are pending. Industry said they are still interested in these substances and will submit safety files as soon as possible.
Although the frequency of reported side effects from the use of hair dyes is low and appears not to increase in spite of an increased use of hair dyeing products, Prof. Andersen repeated his request to industry to supply public certified laboratories with samples of hair dye ingredients for chemical analysis. Such an analysis is regarded as an important tool for public control measures of these substances.
5.4 Inventory
Report of the Co-ordinator
In his report, Prof. Parra said that, further to the adoption of an opinion on the 1st update of section I – Inventory of cosmetic ingredients - of the inventory during the 13th plenary meeting of 28 June 2000, the Working Party concluded also their work on the first update of Section II – Perfume and aromatic raw materials - of the inventory. A draft opinion in this respect was tabled for formal adoption.
Draft opinion on the 1st update of Section II of the inventory, doc. n° SCCNFP/0389/00
Analogous to the opinion on the 1st update of Section I, also this draft opinion on the 1st update of Section II of the inventory has been prepared according to the provisions of the cosmetics directive concerning the role of the inventory, namely being, amongst others, ‘a tool of transparency'.
In order to fulfil this task, the SCCNFP met experts from the European Fragrance Industry and worked in collaboration with the Joint Research Centre of the European Commission.
Where the original list tabulated the entries by their EINECS number and thus did not permit the ready identification of fragrance ingredient by its commonly known trivial name predominating in scientific literature or textbooks, this 1st update tabulates the fragrance and aromatic raw materials in alphabetic order.
About 310 new entries have been added. Their total number is now about 2750. The improvements made to the original version of section II concerns mainly the botanical's entries. However, as the inventory is an evolving document, the SCCNFP proposes already in its opinion a series of approaches as recommendations for future updates.
The draft opinions (i) on the 1st update of Section II of the inventory, doc. n° SCCNFP/0389/00,
(ii) on the introduction to the 1st update of the inventory of cosmetic ingredients, Section II, doc. n° SCCNFP/0399/00, (iii) on the finalisation of botanical's entries to the inventory of Section II, doc. n° SCCNFP/0148/00 and (iv) on the revision of the 1st update of the inventory, Section II, doc. n° SCCNFP/0430/00 have been adopted by the SCCNFP, subject to some modifications of documents SCCNFP/0399/00 and SCCNFP/0430/00.
The SCCNFP especially acknowledged the co-operation with EFFA and its scientific experts in establishing the 1st update of section II of the inventory.
5.5 Preservatives, Colorants & Fragrances
Report of the Co-ordinator
In his report, Dr. White recapitulated briefly the issues discussed since the last plenary meeting :
- fragrances : analogous to the opinion adopted during the 12th plenary meeting of 3 May 2000 on ‘not-to-be-used' fragrance materials, the WP initiated the evaluation of the IFRA restricted fragrance ingredients in view of their proposed inclusion in Annex III, Part 1 - List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down - to Directive 76/768/EEC on cosmetic products. The entries were considered and their ‘suitability' to be on the list was cross-checked with the respective monographs, if available.
- alpha-Hydroxy acids : following the publication of the position paper concerning the safety of AHA's on the internet, 15 comments on the position paper were received, nearly exclusively from industry and national institutes. The WP considered each of the comments and found that (i) the national institutes and the consumer associations could agree with the proposed limitations (ii) industry refers to the same basic data/studies. The comments referring to the therapeutic use fall outside the scope of the issue. The WP concluded that the main points of concern remain unanswered
An open discussion with industry was organised. However, and despite the size of the documentation, the answers were not forthcoming. Therefore industry agreed to do a number of additional experiments (evaluations of the percutaneous absorption, skin barrier integrity and photo-sensitivity) with particular emphasis on the worst case situations and to present the draft protocols of these tests to the Committee for approval.
- enzymes : an issue to be considered by the renewed committee with respect to their possible effects to the skin.
Draft opinion on AHTN, doc. n° SCCNFP/0372/00, final draft
As decided during the plenary meeting of 28 June 2000, the WP re-evaluated the oral and dermal sub-chronic toxicity studies. The reason to do so was the coloration of a series of organs/glands due to the administration of AHTN. Even after the re-evaluation of these studies and the subsequent discussion, it was not clear where the coloration came from and whether the coloration and the toxic effects noted were related or not.
Secondly, the oral study did not reveal a NOEL. Although the effects observed at the low dose level were only slight and of questionable relevance, they were dose-related, consistent or present in both sexes (triglycerides). However, an oral MEL of 5 mg/kg/bw could be assumed and retained as the NOAEL for the calculation of the Margin Of Safety.
The opinion was adopted by the SCCNFP, subject to the following conditions :
* information on the purity of the substance should be provided;
* a new in vitro penetration study has to be provided in accordance with the SCCNFP Notes of Guidance;
* the absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
* in its final statement, the SCCNFP will take into consideration the results of the investigation and characterisation of the coloration of the internal organs in rats (announced in Submission 6).
The above has been formulated only on review of the cosmetic use of AHTN. For the full safety assessment of AHTN, it is necessary to consider as well all other sources of consumer exposure e.g., laundry products.
Classification : 3 and 12 months to deliver requested studies.
Draft opinion on HHCB, doc. n° SCCNFP/0403/00, final draft
Similar things were said concerning HHCB. However, the effects seen were less ‘expressed'.
The opinion was adopted by the SCCNFP, subject to the following condition :
* information on the purity of the substance and its possible isomers should be provided;
* a new in vitro penetration study has to be provided in accordance with the SCCNFP Notes of Guidance;
* the absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
The above has been formulated only on review of the cosmetic use of HHCB. For the full safety assessment of HHCB, it is necessary to consider as well all other sources of consumer exposure e.g., laundry products.
Classification : 3 and 12 months to deliver requested studies.
Draft opinion on Methyleugenol, doc. n° SCCNFP/0373/00, final draft
Further to a IFRA recommendation to cease all use of Methyleugenol due to the fact that it recently has been identified as a genotoxic carcinogen, the SCCNFP has been asked to examine the safety of methyleugenol in order to determine whether it should be placed in Annex II – ‘List of substances which must not form part of the composition of cosmetic products' - of the cosmetics Directive 76/768/EEC.
Whilst methyleugenol is not added directly to cosmetic products, but rather it features as a component of fragrances, such materials have been reviewed previously (e.g. musks) and it is thought appropriate that the use of the material should be prohibited if it poses a health risk.
As a result, the SCCNFP concluded that methyleugenol should not be intentionally added as an ingredient in cosmetic products. However, for a fragrance compound containing methyleugenol naturally present in essential oils, the concentration of methyleugenol should not exceed 0.05% in the fragrance compound. This means that, based on highest exposure, the concentration of methyleugenol in the finished cosmetic product may not exceed 0.01% in a fine fragrance, 0.004 % in eau de toilette, 0.002 % in a fragrance cream, 0.0002 % in other leave-on products and in oral hygiene products, and 0.001% in rinse-off products.
The opinion was adopted by the SCCNFP. Classification 1 for the intended use.
Draft opinion on Oakmoss/Treemoss extracts and appropriate consumer information, doc. n° SCCNFP/0421/00, final draft
This draft opinion enters in the framework of the mandate concerning the safety review of fragrance materials, and in particular concerning appropriate consumer information regarding fragrance allergens. As stipulated in its opinion on fragrance allergy in consumers, opinion adopted during the 10th plenary meeting of 8 December 1999, the SCCNFP said that natural products, such as oakmoss/treemoss should be considered in a separate document.
Most oakmoss extracts are actually mixtures of oakmoss and treemoss extracts and although the main allergens in these extracts have not yet been identified, several candidates exist. Since these extracts are derived from natural products, considerable batch to batch variations are found.
On review of the information presently available, the SCCNFP concluded that oakmoss/treemoss extracts have a well recognised potential to cause allergic reaction in the consumer. In accordance with the above mentioned opinion on fragrance allergy in consumers, appropriate information should be provided to the consumer regarding the presence of oakmoss/treemoss extracts in cosmetic products.
In response to the question asked by the representative of DG ENTR on what exactly should be understood by appropriate consumer information, the Committee said that labelling clearly is the best way to make the consumer aware of the presence of these extracts in cosmetic products. However, labelling is a ‘risk management'-tool, an issue which falls outside the field of competence of the Scientific Committees.
The opinion was adopted by the SCCNFP.
5.6 UV Filters
Report of the Co-ordinator
In his report, Dr. O'Mahony said that the safety assessment of Titanium dioxide, coated/uncoated, for use as an UV filter has been finalised and that a draft opinion was tabled for adoption.
Draft opinion on Titanium dioxide (S75), doc. n° SCCNFP/0005/98
The Committee was requested to consider the safety profile of titanium dioxide to be sufficient to permit its listing in part I of Annex VII – ‘List of UV filters which cosmetic products may contain'- to the cosmetic directive 76/768/EEC.
In its opinion, the committee evaluated the safety of crystalline titanium dioxide, whether or not subjected to various treatments (coating, doping, etc.), and irrespective of its particle size.
As a result, the committee concluded that titanium dioxide is safe for use in sun screen formulations at a maximum concentration of 25% provided that the above mentioned treatments (doping, coating, etc.) do not compromise the safety of the product.
The opinion was adopted by the SCCNFP. Classification 1 at a maximum concentration of 25%.
6. Report of the Chairman
* TAIEX-conference, Bulgaria : Prof. Kemper informed the committee about a presentation he gave on the work of the SCCNFP during the TAIEX conference, a Commission initiative towards candidate Member States.
7. Any Other Business
* 26th adaptation : Dr. Norgaard informed the committee about the outcome of the Ad Hoc Working Party meeting with the Member States concerning the draft 26th adaptation to technical progress of the annexes to the cosmetics directive.
* New mandates : mandates were received requesting the safety review of (i) certain azo-dyes, (ii) 3-Iodo-2-propynyl butylcarbamate, (iii) tea tree oil, (iv) alpha-Tocopherol acetate, (v) dialkanolamines, (vi) methylene chloride alone and in a mixture with 1,1,1-Trichloroethane, (vi) GM cotton, and on (vii) benzoyl peroxide, hydroquinone and hydroquinone methylether.
Prof. Kemper said he will look into the respective files and assign the rapporteurs.
* Further plenary meetings : the date of the first meeting of the renewed committee will be communicated as soon as possible.
Attendance List
Present : Mr K.E. Andersen, Mr N. Loprieno, Mr R. Anton, Mr J. Parra, Mr J-F. Doré, Mr D. O'Mahony, Mr P. Elsner, Mrs V. Rogiers, Mr R. Glomot, Mr T. Sanner, Mr V. Kapoulas, Mr J. Vives Rego, Mr F. Kemper, Mr I. White, Mr B. Lina
External experts : Mr Ph. Masson, Mrs R. Schumann
Commission : Mrs L. Benali DG SANCO, Mrs M. de Solà DG SANCO, Mrs S. Clarke DG SANCO, Mrs F. Drion DG SANCO, Mr L. Norgaard DG ENTR, Mrs S. Bernal DG SANCO, Mr A. Van Elst DG SANCO
Annex
Scientific Committee on Cosmetic and Non-Food Products
Agenda for the 14th plenary meeting (Brussels, 24 October 2000)
1. Adoption of the agenda
2. Detergents in cosmetic and household products, Safety and Health related aspects
Dr. A.-M. Rodeyns, Dr. R. Roggeband, AISE
3. Declaration of interest
4. Approval of the minutes of the 13th plenary meeting of 28.6.00
5. SCCNFP - Specific Working Parties
5.1 Alternatives
Report of the Co-ordinator
Revision of the Notes of Guidance of Guidance for testing of cosmetic ingredients for their safety evaluation
Report on percutaneous absorption of hair dyes
Revision of the Annex 7 of the Notes of Guidance "Guidelines for the safety assessment of the finished cosmetic product"
Understanding of the principles of safety evaluation of finished cosmetic products (for information)
5.2 Detergents
Report of the Co-ordinator
5.3 Hair Dyes
Report of the Co-ordinator
5.4 Inventory
Report of the Co-ordinator
Draft opinion on the 1st Update of Section II – Perfume and Aromatic Raw Materials - of the inventory
Introduction to the 1st update of Section II of the Inventory
Finalisation of the botanical-entries to Section II of the Inventory
Revision of the 1st update of Section II of the Inventory
5.5 Preservatives, Colorants and Fragrances
Report of the Co-ordinator
Draft opinion on AHTN
Draft opinion on HHCB
Draft opinion on Methyleugenol
Draft opinion on Oak moss/Tree moss
5.6 UV Filters
Report of the Co-ordinator
Draft opinion on Titanium dioxide (S75)
6. Report of the Chairman
7. Any other business
* Mandates received
* Future meetings
