SCCS: Minutes of 7th Plenary Meeting held on June 22, 2010 in Brussels
FROM: EU Scientific Committee SCCS (Scientific Committee on Consumer Sfatey)
Posted: October 1, 2010

1. REPORTS FROM THE WORKING GROUPS

1. Cosmetic Ingredients
   The Chairperson of the WG reported on the ongoing work of the Working Group. Draft opinions on cyclomethicone, boron compounds, sodium perborate and perboric acid, dihydroxyacetone, parabens (P82) and polysilicone-15 (S74) were prepared and tabled for formal adoption.
2. Hair Dyes
   The Chairperson of the WG reported on the ongoing work of the Working Group. Draft opinions on o-aminophenol (A14), HC Yellow n° 9 (B69) and on Disperse Violet 1 (C64) were prepared and tabled for formal adoption.
3. Methodologies
   The Chairperson of the WG said that the memorandum on Episkin and the basic criteria for the in vitro assessment of dermal absorption have been revised/updated and tabled for adoption.
4. Nano-materials in Cosmetics
   As the Chairperson was not able to attend, the secretariat reported that one meeting had taken place since the last plenary of 23 March 2010. Further data requested on the ongoing evaluations are expected in autumn 2010.
5. Triclosan (Antimicrobial resistance)
   The Chairperson said that the opinion on triclosan (P32) - antimicrobial resistance – has been finalised after consideration of the comments received during the public consultation period. The opinion is tabled for formal adoption.
6. TTC
   The Chairperson said that more work is needed to align the opinion to the outcome of the meeting of 9 June 2010. A further meeting is planned for 27 September 2010.
7. Sensitisation & Fragrances
   The Chairperson reported on the work of the Working Group: the revision of the opinion on the labelling of 26 fragrance substances.

2. DRAFT OPINIONS - DISCUSSION AND POSSIBLE ADOPTION

1. Cyclomethicone D4 / D5
   
   The SCCP was asked to assess the risk to consumers when octamethylcyclotetrasiloxane is used in cosmetic products.
   
   The SCCS concluded that cyclomethicone (D4, D5) does not pose a risk for human health when used in cosmetic products. Other uses were not considered in this risk assessment.
   This conclusion is based on the currently available in-use concentrations as cited in this opinion.
   It should be noted that D4 is classified as a reprotoxic substance, category 3 [ECB 2006].
   The NOAEL for systemic toxicity (150 ppm) used for this risk assessment also covers reprotoxic effects (NOAEL = 300 ppm).
   The Commission Services should consider whether an environmental risk assessment associated with the use of cyclomethicone (D4/D5) in cosmetic products is required.
   The opinion was adopted.
   
   
2. Boron compounds
   Boron compounds

1. The SCCS was asked to:
   based on the current knowledge on the chemistry, biology and toxicology of boron, inform the Commission which of the substances listed in the annex II, newly classified substances to this mandate, are covered by the entries 1a and 1b of Annex III, of the Cosmetics Directive 76/768/EEC
   
   The SCCS concluded that all substances listed in Annex II of this mandate with the exception of dibutyltin hydrogen borate, are covered by the entries 1a of Annex III of the Cosmetics Directive 76/768/EEC. Tetraborates, as identified in table 1 of this opinion, are also covered by entry 1b of the same annex.
   
2. based on the answer to question 1, and taking into account the scientific data used in the classification of these substances, if:

1. the substances that are covered by the entries 1a and 1b of Annex III and which are currently restricted by Directive 76/768/EEC at a maximum use concentration above the specific concentration limits for classification set out in the Commission Regulation 790/2009 are safe when used in cosmetic products below the specific concentration limits set out in the Commission Regulation 790/2009?
   
   The SCCS pointed out that a threshold can be established for the reproductive toxicity of boron compounds. On this basis boric acid, borates and tetraborates are safe when used under the conditions laid down in entry 1a of Annex III. Moreover, tetraborates are safe under the conditions laid down in entry 1b of Annex III if the maximum authorised concentration in the finished cosmetic products is reduced to < 5.5% (by mass as boric acid). Sodium perborate and perboric acid are discussed in a separate Opinion (SCCS/1345/10).
   Exposure to borate compounds from uses other than cosmetics was not taken into account for this risk assessment.
   
2. the substances that are not covered by the entries 1a and 1b of Annex III can safely be used in cosmetic products at concentrations levels below the specific concentrations limits laid down the Commission Regulation 790/2009?
   
   In Annex II of this mandate, the SCCS has only identified dibutyltin hydrogen borate that is not covered by entries 1a and 1b of Annex III. No specific concentration limit is given for this substance in Commission Regulation 790/2009; therefore no risk assessment for the use in cosmetic products has been performed.

Octaborates

3. Based on the current scientific knowledge on the chemistry, biology and toxicology of boron and its compound does the SCCS consider that octaborates are covered by Annex III of the Cosmetics Directive, entry 1a and 1b? If covered, considering that octaborates are not classified, should the current restrictions limits of Annex III entry 1a and 1b be applied for the octaborates?

3. Sodium perborate and perboric acid
   The SCCS was asked:
   1. Based on the current knowledge on the chemistry, biology and toxicology of sodium perborate and perboric acid, does the SCCS consider that sodium perborate and perboric acid can be considered as "hydrogen peroxide" releasing substances in the sense as the already regulated substances in Annex III, entry 12 of the Cosmetics Directive 76/768/EEC?
      
      The SCCS concluded that sodium perborate and perboric acid can be considered as “hydrogen peroxide” releasing substances and thus are covered by the entries 12 of Annex III, of the Cosmetics Directive 76/768/EEC,
      
   2. If the answer to question 1 is yes, does the SCCS consider that the general restrictions applicable to hydrogen peroxide releasing substances should apply to sodium perborate and perboric acid?
      
      The SCCS considered that the general restrictions applicable to hydrogen peroxide releasing substances should apply to sodium perborate and perboric acid. As laid out in opinion SCCS/1249/09, the substances listed in the Annex I of this mandate are, in addition to entry 12 of Annex III, also covered by entry 1a of Annex III of the Cosmetics Directive 76/768/EEC. The more restrictive of the two entries should be applied.
      
   3. Furthermore, does the SCCS consider with the provided scientific data that sodium perborate is safe, when used in (powdered), oxidative hair dye formulations up to a maximum concentration on the head of max.3.0% calculated as boric acid corresponding to a release of x volume percentage hydrogen peroxide?
      
      The SCCS concluded that the use of sodium perborates as an ingredient in oxidative hair dye formulations with a maximum on-head concentration of 3% will not pose a risk to the health of the consumer.
      Exposure to sodium perborate and boric acid from other uses, except the use in cosmetics according to Annex III, entry 1a of the Cosmetics Directive 76/768/EEC, was not taken into account for this risk assessment.
      The SCCS notes, however, that the hair dye powder formulation as supplied to the consumer contains 30% sodium perborate monohydrate. It other types of consumer products this would require labelling as “Toxic” and such products would not be generally available to consumers.
      
   4. Sodium perborate and perboric acid have different classifications depending on the percentage content of particles with an aerodynamic diameter below 50 μm. Does the SCCS consider that this has an impact on their safe use in cosmetic products?
      
      The SCCS considered that the percentage content of particles with an aerodynamic diameter below 50 micrometer does not have an impact on the safety of sodium perborate and perboric acid when used in a liquid cosmetic formulation. However, in connection to the use addressed in question 3, exposure of consumers to powdered formulations can occur. When using powdered formulation, exposure via inhalation can take place when particles with sizes in the inhalable range (i.e. <15 micrometer) are present. Therefore the SCCS considers that the different classification with regard to percentage content may indeed have an impact on their safe use in consumer products. However, since no information on the particle size distribution of the powder is available, the risk of inhalation of particles due to use of the powdered formulation cannot be assessed.
      The opinion was adopted.
      
4. Dihydroxyacetone
   After consideration by the plenary, this opinion was found to need further discussion and was referred back to the Working group. The adoption of the opinion was postponed.
5. Erythrosine
   The SCCP was asked to assess the risk to consumers when CI 45430 (erythrosine) is used as a colorant in toothpaste products with a maximum concentration of 0.0025% (25 ppm).
   The SCCS concluded that CI 45430 (erythrosine) safe for consumers when used as a colorant in toothpaste products with a maximum concentration of 0.0025 % (25 ppm). Concerning intake from cosmetics (use in toothpastes only), erythrosine has a very high MoS and intake represents only a small fraction of the ADI of 0.1 mg/kg/day. However, aggregate exposure to erythrosine is possible due to other uses (e.g. food, medical products). Exposure from sources different from toothpaste has not been addressed in this opinion.
   The opinion was adopted.
6. P82, Parabens
   After consideration by the plenary, this opinion was found to need further discussion and was referred back to the Working group. The adoption of the opinion was postponed.
7. S74, Polysilicone-15
   The SCCS was asked to assess the risk to consumers when Polysilicone-15 is used in cosmetic products at a concentration up to 10%, taken into account the new provided scientific data on inhalation.
   In 1999, the SCCNFP concluded that Polysilicone-15 (Dimethicodiethylbenzalmalonate) is safe for use in cosmetic products as a UV light absorber at a maximum concentration of 10%. In this case only exposure following dermal application was assessed.
   In the present assessment, using a weight of evident approach, the SCCS concluded that the use of Polisilicone-15 at a concentration of 0.1% in pressurised hairsprays does not constitute a risk for the consumer.
   With regard to the trigger sprays, no risk of the use of Polysilicone-15 is to be expected, as long as the generated particle sizes in the lower tail of the distribution are above the inhalable size (i.e. >15 microm).
   The opinion was adopted.
8. P32, Triclosan – antimicrobial resistance
   During the 6th plenary meeting of 23 March 2010, the SCCS adopted a preliminary opinion on triclosan – antimicrobial resistance.
   In line with the procedures for stakeholder dialogue, published on 15 September 2007, the European Commission opened a public consultation on this preliminary opinion from 29 March to 26 May 2010.
   In total, 10 contributions were received of which 5 were from public authorities, 3 from industry and two from individuals with professional links to this issue. Each contribution was carefully considered and a response was formulated.
   The opinion has been revised taking into account all relevant comments. The scientific rationale and the opinion were clarified and strengthened in certain respects.
   The overall opinion, however, remains unchanged.
9. A14, o-Aminophenol
   The SCCS was asked to assess the safety of o-aminophenol in oxidative hair dye formulations at a maximum on-head concentration of 0.6%.
   The SCCS concluded that, based on the submitted data, no final conclusion on the safety of o-aminophenol can be drawn.
   The data provided for physicochemical properties of o-aminophenol are insufficient and inadequate; no scientifically sound expert judgement can be made on the purity of o-aminophenol batches or on the homogeneity or stability of o-aminophenol or its formulations. Inadequate information on skin sensitising potential was provided. The studies on dermal absorption had many shortcomings and were not considered suitable for safety assessment.
   Due to inadequacy of the studies provided, a mutagenic potential cannot be excluded.
   Before any further reconsideration, the following is required:

• a complete set of physico-chemical data,
• a study on skin sensitisation according to the state of the art,
• a dermal absorption study according to the Notes of Guidance,
• a well performed gene mutation test and a chromosomal aberration/micronucleus test

in mammalian cells in vitro according to current guidelines to exclude mutagenicity.
Studies on genotoxicity/mutagenicity in finished hair dye formulations should be undertaken following the relevant SCCNFP/SCCP opinions and in accordance with its Notes of Guidance.
The opinion was adopted.

10. B69, HC Yellow n° 9
    The SCCS was asked to assess the safety of HC Yellow n° 9 in non-oxidative hair dye formulations at a maximum on-head concentration of 0.5%. The SCCS concluded that, based on the information provided, the use of HC Yellow n° 9 as a non-oxidative hair dye ingredient at a maximum concentration on the head of 0.5% does not pose a risk to the health of the consumer. A sensitising potential of HC Yellow n° 9 cannot be excluded.
    HC Yellow n° 9 is a secondary amine, and thus is prone to nitrosation and formation of nitrosamines. It should not be used in combination with nitrosating substances. The nitrosamine content should be < 50 ppb.
    The opinion was adopted.
11. C64, Disperse Violet
    The SCCS was asked to assess the safety of Disperse Violet 1 in non-oxidative hair dye formulations at an on-head concentration of 0.5%. The SCCS concluded that, based on the information provided, the use of Disperse Violet 1 in semi-permanent hair dye formulations at a maximum concentration of 0.5% does not pose a risk to the health of the consumer, apart from its moderate skin sensitising potential. The fully characterised batches of Disperse Violet 1 contained up to 3% Disperse Red 15.
    According to Cosmetic Directive Annex II, Disperse Red 15 is only permitted as an impurity in Disperse Violet 1, but without concentration limit. The test batches of Disperse Violet 1 used for the main studies of the safety evaluation contained < 1% Disperse Red 15. Therefore, the impurity of Disperse Red 15 in Disperse Violet 1 for hair dye formulations should be <1% (w/w).
    The opinion was adopted.
12. Updated Memorandum on Episkin
    The adoption of the memorandum was postponed.
13. Basic Criteria for the in vitro assessment of dermal absorption of cosmetic ingredients
    The basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients were last updated in 2006 (doc. n° SCCP/0970/06).
    The application of this update, however, resulted frequently in a disagreement on the number of skin samples and donors, the concentrations to be tested, the variability of the test results and the value to be used for the calculation of Margin of Safety (MoS). This led to the non-acceptance of a number of studies submitted.
    These disagreements and the use of default values <100% for dermal absorption in the absence of appropriate experimental data, were discussed with experts in a special meeting on dermal absorption in October 2002. The conclusions of this meeting have been incorporated in the present update and will also be included in the on-going revision of the SCCS Notes of Guidance.
    The dermal absorption of nanoparticles is not covered by this update.
    The document was adopted.

3. COMMENTS ON OPINIONS ADOPTED DURING THE PLENARY MEETING OF 8 DECEMBER 2009

Comments have been received on the following opinions adopted in the SCCS plenary meeting of 23 March 2010:

• Melatonin
• Vitamin K1
• A11, resorcinol
• A12, 4-chlororesorcinol
• A80, hydroxy-p-phenylenediamine sulfate
• B15, Acid Black 1
• B34, N,N'-bis-(2-hydroxyethyl)-2-nitro-p-phenylenediamine
• C10, Basic Yellow 57

After consideration of the comments received, the opinions were revised where appropriate.

FINAL REPORT ON THE EU SCIENTIFIC COMMITTEES ACTIVITIES FOR 2004-2009
FROM: EU Scientific Committees
Posted: September 27, 2010

Executive summary

1. Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)
   During its mandate from September 2004 to January 2009, the SCENIHR adopted 18 opinions, and one position paper. The focus of the work of SCENIHR was on Nanotechnologies (4 opinions), biological hazards (3 opinions – human-derived products and variant Creutzfeldt Jacob disease, human blood/organs and West Nile Virus, Bovine spongiform encephalopathy (BSE) risks from cosmetic ingredients), Antimicrobial resistance (2, one of which was developed and adopted jointly with SCHER), physical hazards (4 opinions – Electro Magnetic Fields-EMF (2), personal music players, energy-efficient light bulbs) and Medical Devices (2 opinions – dental restoration materials (1), plasticizers (1)). Further work was carried out on smokeless tobacco products. Two opinions were jointly adopted with SCCP and SCHER: One concerned the Threshold of Toxicological Concern (TTC) and the other was on the methodologies for genotoxic and carcinogenic substances.
2. Scientific Committee on Consumer Products (SCCP)
   During its mandate from September 2004 to January 2009, the SCCP adopted 180 opinions, guidance documents, memoranda and position statements. Out of these 180 documents, 178 were related to cosmetic products. Only 2 opinions concerned other consumer products (sun beds and nitrosamines in rubber balloons). In addition to opinions and technical advice which were developed on request from other services, the SCCP issued two guidance documents, most notably a major update of the Notes of Guidance for applicants, as well as six memoranda and position statements.

1. Hair Dye evaluations under the European Hair Dye Strategy
   Following reports that hinted to a link between the use of hair dyes and certain cancer types (bladder cancer, leukaemia), and a recommendation of the SCCNFP, the Commission developed a strategy to review and regulate all hair dye substances on the European market. This involved submission of updated safety information for these substances and evaluation by the Scientific Committee. After the submission deadlines, data for 117 hair dyes had been submitted. 50 hair dye ingredients have been finally assessed as safe, 5 were considered to pose a risk to the consumer. Of the initial evaluations, 25 could not be finalised since the SCCP considered the data submitted insufficient and requested additional information or studies. For 7 of the ingredients concerned, the requested data has been already provided and awaits further assessment, while for 18, a further submission is pending. Including some new submission that were made on hair dyes developed since the start of the hair dye strategy, altogether 40 hair dyes remain to be assessed.
2. Hair dye assessments
   So far, 176 hair dye substances have been included in Annex II of the Cosmetics Directive (including the 20 banned before the start of the strategy). 25 substances with hair dyeing properties without updated safety file have not been banned yet since they are also used as colorants in cosmetics or in food. Of the hair dyes already assessed by the SCCP, 17 that have received a positive evaluation were proposed for regulation in Annex III, part 1. The respective directive was published in the OJ on 16 April 2009.
3. Hearing on Parabens
   Different parabens (methyl-, ethyl-, butyl-, propylparaben) are widely used as preservatives in cosmetic products. While the SCCP had evaluated methyl- and ethylparaben as safe, some study results on butyl- and propylparaben had been a matter of extensive discussion during the evaluation process. To identify a way forward and a strategy to come a final assessment of these substances, the Commission and the SCCP organised a hearing on 23 October 2007. Three parties expressed interest after the publication of the announcement and were invited to the meeting. The available scientific data, their shortcomings and additional research that could support the safe use of the substances were discussed during the meeting. This meeting, together with material submitted subsequently, formed the basis of the SCCP opinion on parabens of 24 June 2008 (available from CosmExpert/CosSafe download center), discussing the Industry proposal for further research and giving additional recommendations.

3. Scientific Committee on Health and Environmental Risks (SCHER)
   …, the focus of the work of SCHER was on Risk Assessment Reports on existing chemicals under Regulation 793/93/EC (86 opinions), risk assessment (10 opinions – Detergents (4), cadmium in fertilizers, organotin (stannous derivatives) compounds, mercury in dental amalgam, organic chemicals in toys, antifouling paints used on boats, and phthalates in school supplies), chemicals in products (dichloromethane in paint strippers), specific environmental issues (perfluoroctane sulfonate), ISO standard (ISO 10708 - Water quality), air quality (3 opinions – indoor air quality, air pollution, and air fresheners), non-animal testing (2 opinions – endocrine disruptors and non animal testing, and use on non-human primates in research), biological risks (antimicrobial resistance). Further work was carried out on research priorities for the 7th Framework Program (1 opinion). Moreover, two opinions were jointly adopted with SCCP and SCENIHR. One opinion was on the Threshold of Toxicological Concern (TTC) and one on the methodologies for genotoxic and carcinogenic substances.

SCHER, SCENIHR will meet on next September 16 and 20
FROM: SCCS, SCHER, SCENIHR - 15 September 2010
Posted: September 15, 2010

Agendas deal with Risk Assessment, TRIS in toys, water Directive, Threshold of Toxicological Concern (TTC), Nanodefinitions, tobacco additives, ...

Week 36 (4-10 September 2010), Addressing the new Challenges for Risk Assessment
FROM: SCCS, SCHER, SCENIHR - 4-10 September 2010
Posted: September 13, 2010

SCCS, SCHER, SCENIHR: Requests for Scientific Opinions
Addressing the new Challenges for Risk Assessment
The SCENIHR, SCCS and SCHER are requested to carry out a comprehensive review of risk assessment procedures and new challenges for RA taking into account both fundamental and practical considerations (sampling, instrumentation, cost, analysis, etc.), and to provide a scientific opinion on the issue in co-operation, as appropriate, with external experts who are specialists in relevant new methodologies.
It is proposed that the chairs of SCENIHR, SCHER and SCCS identify a small group of experts representing the different sectors and key disciplines.
Deadline: December 2011.

2011, CIR priority list
FROM: CIR, September 2,2010
Posted: September 6, 2010

On 2 September 2010, CIR has identified 20 ingredients as high priorities for review in 2011.

Requests for Scientific Opinions
FROM: EC Scientific Committees – Week 33/2010
Posted: August 20, 2010

Hair dyes:
HC Red No. 10 and HC Red No. 11 (CAS No 95576-89+95576-92-4) submission III (B71)
4-Nitrophenyl aminoethylurea (CAS 27080-42-8) submission III (B070)
HC Red No. 13 (CAS 94158-13-1) submission III (B031)
Basic Brown 17 (CAS No 68391-32-2) submission IV (B7)
2,7-Naphthalenediol (CAS No 582-17-2) (A19)
1,5-Naphthalenediol (CAS No 83-56-7) (A18)

Alternatives to animal testing for cosmetics: public consultation launched
FROM: European Commission
Posted: August 12, 2010

On 23 July 2010, the Commission launched a public consultation on a draft report on alternative methods for cosmetic testing. Comments are sought on alternatives available in testing for certain health-related effects which are covered by the 2013 deadline for the marketing ban on animal-tested cosmetics covering repeated dose toxicity, skin sensitisation, carcinogenicity, toxicokinetics and reproductive toxicity.
The public consultation ends on 15 October 2010. This consultation is part of the phasing out of animal testing of cosmetic ingredients. The testing ban on finished products applies since 2004, and on ingredients since 2009. The marketing ban applies since March 2009 with the exception of testing for three kinds of human health-related effects (repeated-dose toxicity, reproductive toxicity and toxicokinetics), for which the deadline is extended to March 2013. In early 2011, the Commission will report on the availability of and prospects for the alternatives to testing for these three types of effects.
Target group: All citizens and organisations can contribute
Period of consultation: 23 July - 15 October 2010
Expected publication date of the final report: end of 2010/early 2011.

EU Regulation No. 1223/2009 - also referred to as "8th amendment" to the Cosmetic Directive
FROM: EUROPEAN PARLIAMENT AND COUNCIL
Posted: August 1, 2010

EU has published the Regulation No. 1223/2009, dated November 25, 2009. This long expected document is also referred to as the 8th Amendment to the Cosmetic Directive 76/768/EEC or the Recast. Going into effect on July 11, 2013, it eliminates the confusion that stemmed from adaptations of the previous Directive by Member countries such as national forms for national Poison centers, national definitions of safety assessors , national product notification or national notification charges. A special mention must be made about the Cosmetic product safety information, which should contain at least the following points according to Annex I:

1. Quantitative and qualitative compositions of cosmetic products including the chemical identities of substances contained therein as described by chemical name, INCI name, CAS and EINECS/ELINCS numbers, where possible; and their intended function. In the case of perfume and aromatic compositions, descriptions of the name, the code number of the composition and the identity of the supplier are required.
2. The physical and chemical characteristics and stability of the substances or mixtures of the cosmetic product as well as for the product itself. The stability of the cosmetic product should be based on foreseeable storage conditions.
3. Microbiological quality; the microbiological specifications of the substance or mixture and the cosmetic product. The results of preservation challenge testing should also be included.
4. Information regarding the purity of substances and mixtures and information on impurities and trace ingredients about the material; in cases where traces of prohibited substances are present, evidence for their technical unavoidability is required. The relevant characteristics of packaging material, particularly purity and stability, should also be included.
5. Normal and reasonably foreseeable use; the reasoning should be justified in the light of warnings and other explanations given on the product labeling.
6. Exposure to the cosmetic product; data on the exposure of individuals to the cosmetic product should be given, taking into consideration the findings under Section 5 in relation to: The site(s) of application; the surface area(s) of application; the amount of product applied; the duration and frequency of use; the normal and reasonably foreseeable exposure route(s); and the targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account. The calculation of the exposure should also take into consideration the toxicological effects to be considered; e.g. exposure may need to be calculated per unit area of skin, or per unit of body weight. The possibility of secondary exposure by routes other than those resulting from direct application should also be considered; e.g. the non-intended inhalation of sprays, non-intended ingestion of lip products, etc. Particular consideration should be given to any possible impacts on exposure due to particle sizes.
7. Exposure to the substances; data on exposure to the substances contained in the cosmetic product is required for the relevant toxicological endpoints, taking into account the information under Section 6.
8. Toxicological profile of the substances; without prejudice to Article 18 (Animal testing), the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints should be included. A particular focus on local toxicity evaluation for skin and eye irritation, skin sensitization, and in the case of UV absorption, photo-induced toxicity should be made. All significant toxicological routes of absorption should be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL), which should be calculated. According to this requirement, the absence of these considerations should be duly justified. Particular consideration should be given to any possible impacts on the toxicological profile due to particle sizes including nanomaterials, impurities of the substances and raw materials used, and interactions of substances. Any read-across should be duly substantiated and justified, and the source of the information should be clearly identified.
9. Undesirable effects and serious undesirable effects; all available data on the undesirable effects and serious undesirable effects of the cosmetic product or, where relevant, other cosmetic products must be included with statistical data.
10. Information on the cosmetic product; other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas, should also be included.

Last, but not least, Annexes have been renumbered: preservatives will be covered by Annex V (now Annex VI) and sunscreens by Annex VI (now Annex VII).

International Cooperation on Cosmetic Regulation (ICCR), Outcome of the Meeting held July 13 – 15, 2010
FROM: ICCR
Posted: July 29, 2010

Outcomes of the Meeting

1. Alternative Test Methods

• Regulators received an updated report on International Cooperation on Alternative Test Methods (ICATM) activities.
• Regulatory authorities will continue to cooperate, to coordinate and to endorse ICATM activities.

2. Cosmetics Labeling

• Industry working group identified three areas of labeling misalignment:

• Small packaging
• Declaration of net quantity of contents
• Net content and warnings on aerosol products

• ICCR regulators decided not to form a labeling ICCR WG at this time.

3. Involvement of Interested Parties in ICCR

• Regulators will develop criteria to allow interested parties to submit detailed proposals for work items for ICCR members’ consideration.
• Regulators reviewed criteria for new regulatory membership to finalize for future adoption.

4. Nanotechnology

• Regulators and industry discussed the report of the ICCR Ad Hoc Nanotechnology Working Group (Nano WG) that was formed in December 2009 to develop criteria for identification of nanomaterials within the context of cosmetic regulation.
• Regulators will publish the report on their respective websites for consideration in future nanotechnology-related activities in the four jurisdictions.
• This Nano WG has concluded its work with the finalization of the report. A new Nano WG will be formed to examine safety approaches.

5. Standard Operating Procedures of Working Groups

• Regulators developed a draft Standard Operating Procedure for Working Groups under the ICCR framework, for adoption in the near future.

6. Sunscreens

• Regulators shared information on approaches to sunscreen regulation.

7. Trace Contaminants

• ICCR Ad Hoc Traces Working Group provided a status update on the development of a trace materials framework document and recommendations for maximum lead contamination levels.
• Work will continue on the framework document and on recommendations for three trace contaminants (lead, 1,4-dioxane and mercury)

'Groundbreaking' Initiative from Personal Care Products Council would Establish an Additional Layer of Federal Oversight & Enhance Existing Consumer Safeguards
FROM: Personal Care Products Council (former CTFA)
Posted: July 15, 2010

In a groundbreaking initiative intended to enhance existing protections for millions of American consumers, the US cosmetics industry today announced plans to support legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.
The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. No such FDA processes currently exist.
US cosmetics Industry emphasized the proactive nature of today’s announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use. Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

France: merging of 2 government agencies (food and environment)
FROM: Miscellaneous press articles
Posted: February 23, 2010

As of mid 2010, a new government agency will be in charge of both food and environment matters making up for a staff of 1400 officers (announcement back early January 2010).
They will have to deal with nanomaterials, GMO's and pesticides, just to mention some hot cases among many others...
Based on experience, criticisms have started circulating about probable conflicts of interests - a local disease ? - at the top management level as well as a possible confusion between risk assessment and risk management.
Indeed, the new agency will be monitored by a governing body with 36 members. Five ministries will send one representative each having 5 votes each, business will have 9 seats, hence leaving 22 seats for the agency, which gives this final count: government: 25 votes, agency: 22 and business:9!

In-cosmetics 2010 Lifetime Achievement Award: shortlist announced!
Posted: February 5, 2010

The wait is over. The nominations have been counted and the shortlist for the in-cosmetics 2010 Lifetime Achievement Award can finally be announced! Dr. Alain Khaiat, Dr. Karl Lintner, Dr. Daniel Maes and Dr. Johann Wiechers have all been selected as finalists and will now battle it out in a public vote.
Allez les Bleus! (ie come on Blues!)...

Posted: February 4, 2010

EU Adds Ethyl Lauroyl Arginate HCl to Annexes III/1,entry No 207 and Annex VI, Part 1, entry No 58

Direct conversion of fibroblasts to functional neurons by defined factors
FROM: Nature advance online publication - 27 January 2010 / Stanford University School of Medicine
Posted: January 30, 2010

Starting from a pool of nineteen candidate genes, researchers identified a combination of only three factors, Ascl1, Brn2 (also called Pou3f2) and Myt1l, that suffice to rapidly and efficiently convert mouse embryonic and postnatal fibroblasts into functional neurons in vitro. These induced neuronal (iN) cells express multiple neuron-specific proteins, generate action potentials and form functional synapses.
Generation of iN cells from non-neural lineages could have important implications for studies of neural development, neurological disease modelling and regenerative medicine.
Comment: This work may be considered as part of the effort to overcome the ethic objection against using embryonic stem cells.

Availability and potential use of 3R-alternatives in the European cosmetic field
From: Scientific Committee on Consumer Safety
Posted: January 26, 2010

Only for 5 endpoints validated replacement alternatives are available. However, for the human health risk assessment of cosmetic ingredients other endpoints are also crucial and these are not covered by meaningful and resilient replacement testing methods. In addition, the majority of the existing alternative methods is only suitable for hazard identification of cosmetic ingredients and do not give information on potency. Thus, a full human health risk assessment cannot be performed.

The actual endpoints for which replacement alternatives suitable for cosmetic hazard testing, are available [and presented in] table 1. In addition, it indicates which endpoints are affected by:

• The European testing ban (2009), meaning that no replacement alternatives are available to provide the same level of safety insurance generated by the original in vivo studies that are not allowed to be performed on EU territory to meet the requirements of the Cosmetic Products Directive after 11 March 2009.
• The European marketing ban (2009), meaning that no replacement alternatives are available to provide the same level of safety insurance generated by the original in vivo studies to which an ingredient may not be subjected after 11 March 2009 to meet the requirements of the Cosmetic Products Directive; otherwise marketing a cosmetic product containing that ingredient becomes prohibited.
• The European marketing ban (2013), meaning that no replacement alternatives are available to provide the same level of safety insurance generated by the original in vivo studies to which an ingredient may not be subjected after 11 March 2013 to meet the requirements of the Cosmetic Products Directive; otherwise marketing a cosmetic product containing that ingredient becomes prohibited. Due to the imposed testing ban on cosmetic ingredients, in vivo assays falling under this category and performed between 11 March 2009 and 11 March 2013, need to be done outside the EU.

Table 1: Actual status of available replacement alternatives and impact of European cosmetic testing and marketing bans

Validated replacement alternatives available	No validated replacement alternatives available
→ endpoints not affected by EU testing or marketing ban	→ endpoints affected by EU testing ban (2009) EU marketing ban (2009)	→ endpoints affected by EU testing ban (2009) EU marketing ban (2013)
skin corrosivity skin irritation dermal absorption mutagenicity/ genotoxicity* phototoxicity	acute toxicity eye irritation	repeated dose toxicity: skin sensitisation sub-acute toxicity sub-chronic toxicity chronic toxicityv carcinogenicity reproductive toxicity toxicokinetics

* Since the well-established mutagenicity / genotoxicity in vitro testing battery is afflicted by the frequent occurrence of false positive results, many cosmetic ingredients run the risk to wrongly be rejected due to the prohibition on in vivo follow-up studies.

Finding Out Egyptian Gods’ Secret Using Analytical Chemistry: Biomedical Properties of Egyptian Black Makeup Revealed by Amperometry at Single Cells
From UMR CNRS 8640 “PASTEUR” and LIA CNRS XiamENS “NanoBioChem”, UMR CNRS 171 “C2RMF”
Posted January 12, 2009

Lead-based compounds were used during antiquity as both pigments and medicines in the formulation of makeup materials. Chemical analysis of cosmetics samples found in Egyptians tombs and the reconstitution of ancient recipes as reported by Greco-Roman authors have shown that two non-natural lead chlorides (laurionite Pb(OH)Cl and phosgenite Pb2Cl2CO3) were purposely synthesized and were used as fine powders in makeup and eye lotions.
According to ancient Egyptian manuscripts, these were essential remedies for treating eye illness and skin ailments.

This conclusion seems rather odd because today we focus only on the well-recognized toxicity of lead salts. Here, using ultramicroelectrodes, researchers have obtained new insights into the biochemical interactions between lead(II) ions and cells, which support the ancient medical use of sparingly soluble lead compounds. Submicromolar concentrations of Pb2+ ions are shown to be sufficient for eliciting specific oxidative stress responses of keratinocytes. These consist essentially of an overproduction of nitrogen monoxide (NO°).
Owing to the biological role of NO° in stimulating nonspecific immunological defenses, one may argue that these lead compounds were deliberately manufactured and used in ancient Egyptian formulations to prevent and treat eye illnesses by promoting the action of immune cells.

From CosmExpert.com:
Posted: January 1st, 2010
Happy new year 2010 to you all !

Indonesian Cosmetic Manufacturers Request Free Trade Postponement
Posted: December 22, 2009

Indonesian cosmetics and herbal medicine producers are requesting an exemption for their products from the ASEAN-China free trade agreement, according to a report from the Jakarta Globe.
The Agreement on Trade in Goods (TIG) of the Framework Agreement on Comprehensive Economic Cooperation between ASEAN and China, also referred to as the ASEAN-China Free Trade Agreement, was signed by the Economic Ministers of ASEAN and China in November 2004. According to this agreement, the free trade is to be established by Jan. 1, 2010, between China and the ASEAN countries: Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore and Thailand. Similarly, free trade between China and the newer ASEAN member states: Cambodia, Lao People's Democratic Republic, Myanmar and Vietnam, is expected by 2015. The Indonesian Cosmetic Association (Perkosmi) has reportedly requested a postponement in the implementation of the agreement, specifically in relation to cosmetics and jamu (herbal medicine) imports. According to the report, Indonesian cosmetic manufacturers are concerned about competing with illegal Chinese imports that are cheaper, some of questionable quality. The manufacturers have asked for stricter supervision of cosmetics and jamu products, calling upon the Health Ministry's Food and Drug Monitoring Agency (BPOM) to conduct quality checks on them since, reportedly, Chinese labels often have been found not to be legal.

1,4-Dioxane
FDA - Posted: November 19, 2009

Chemical Name: 1,4-Dioxane
IUPAC International Chemical Identifier: InChI=1/C4H8O2/c1-2-6-4-3-5-1/h1-4H2

What is 1,4-dioxane?
The compound 1,4-dioxane is a contaminant that may be present in extremely small amounts in some cosmetics. It forms as a byproduct during the manufacturing process of certain cosmetic ingredients. These ingredients include certain detergents, foaming agents, emulsifiers and solvents identifiable by the prefix, word, or syllables "PEG," "Polyethylene," "Polyethylene glycol," "Polyoxyethylene," "-eth-," or "-oxynol-." However, 1,4-dioxane itself is not used as a cosmetic ingredient.

Is 1,4-dioxane in cosmetic products harmful?
The levels at which a chemical compound would be considered harmful in a cosmetic depend on the conditions of use (FDC Act, section 601(a)). The 1,4-dioxane levels we have seen in our monitoring of cosmetics do not present a hazard to consumers. Concerns initially were raised in the 1970s, when studies at the National Cancer Institute found an association between1,4-dioxane and cancer in animals when 1,4-dioxane was administered in high levels in the animal feed. However, the levels in cosmetic products are far lower than those found to be harmful in feeding studies and, for the most part, the types of products in which it is found are only in contact with the skin for a short time. As a precaution, FDA followed up with skin absorption studies, which showed that 1,4-dioxane can penetrate animal and human skin when applied in certain preparations, such as lotions. However, further research by FDA determined that 1,4-dioxane evaporates readily, further diminishing the already small amount available for skin absorption, even in products that remain on the skin for hours. (Robert L. Bronaugh, "Percutaneous Absorption of Cosmetic Ingredients," in Principles of Cosmetics for the Dermatologist, Philip Frost, M.D., and Steven Horwitz, M.D., Eds. St. Louis: The C.V. Mosby Company, 1982)

What is FDA doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane?
FDA has been monitoring this issue since the late 1970s. We periodically monitor the levels of 1,4-dioxane in cosmetic products, and have observed that the changes made in the manufacturing process have resulted in a significant decline in the levels of this contaminant. (Roderick E. Black, Fred J. Hurley and Donald C. Havery, "Occurrence of 1,4-Dioxane in Cosmetic Raw Materials and Finished Cosmetic Products," Journal of AOAC International, 84 (3), 2001, pp. 666-667) FDA has not established or recommended a specific limit on the level of 1,4-dioxane in cosmetics. We have provided guidance to manufacturers alerting them to the health concerns and how to minimize 1,4-dioxane by means of a process called "vacuum stripping" at the end of the polymerization process. This information has been posted on our Web site in the Cosmetic Handbook for Industry: Cosmetic Product-Related Regulatory Requirements and Health Hazard Issues. We also provide FDA inspectors with information on this procedure in our Guide to Inspections of Cosmetic Product Manufacturers so that when they conduct inspections they will know what to look for and what questions to ask. If FDA were to determine that a health hazard exists, it would advise the industry and the public, and would consider its legal options for protecting the health and welfare of consumers. For more on the subject of cosmetic safety and the law, see FDA Authority Over Cosmetics, Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded", and the cosmetics provisions of the Federal Food, Drug, and Cosmetic Act.