DRAFT MINUTES - cosmetics - personal care products



MINUTES

SAFETY AND REGULATORY TOXICOLOGY COMMITTEE

A meeting of the Safety and Regulatory Toxicology Committee was held in Washington D.C. on May 1, 2007. Attending were:

Ms. Louise Aust, Dial

Dr. Javier Avalos, KAO

Dr. Dan Bagley, Colgate-Palmolive

Ms. Donna Beach, L’Oreal USA

Ms. Roberta Bloom, Combe

Dr. Joel Burdick, Beauty Avenues

Ms. Amy Burrows, Johnson Diversey

Ms. Rosa Carreon, Dow-Corning

Mr. Anthony Dulichan, Revlon

Dr. Nick Fendinger, Procter & Gamble

Ms. Tina Flaherty, Kimberly-Clark

Dr. Annahita Ghassemi, Church & Dwight

Mr. Chris Havanas, Gojo

Ms. Maggie Hibbs, Croda

Dr. Akihiro Kinoshita, Shiseido

Dr. Lambros Kromidas, Coty

Dr. Catherine Lazaro, Alberto-Culver

Mr. David Mallon, Unilever

Dr. Tim McCarthy, Johnson & Johnson

Dr. Laurie Pan, Sally Beauty

Ms. Helene Paty, Chanel

Dr. Tom Re, L’Oreal USA

Dr. Kevin Renskers, Takasago

Ms. Noriko Shibuya, Shiseido

Dr. Weiyi Su, Estee Lauder

Dr. Pushpa Vavilikolanu, Alberto-Culver

Dr. Jane Vergnes, ISP

Dr. Eric Winkelman, GlaxoSmithKline

Dr. Sherwin Yan, Playtex

Dr. Linda Loretz, CTFA

Dr. Carol Eisenmann, CTFA

Dr. Jay Ansell, CTFA

1) Opening Remarks

a) Chairman’s Welcome

i) JBurdick opened the meeting and welcomed those present.

b) Minutes

i) JBurdick asked if there were any additions, corrections, or deletions to the minutes of the previous meeting held on February 21, 2007. The minutes were accepted as written (with document numbers still to be added).

c) Agenda Review

i) There were no additions to the agenda. It was noted that in the future, as discussed at the February meeting, a reminder/solicitation would go out with the agenda before each meeting to see if there were Discussion Forum topics to be added to the agenda.

2) SRTC Projects

a) Raw Material Information Form

i) The Raw Material Information Form (RMIF) has been sent via e-mail to all of the CTFA technical committees, and a notice appeared in the CTFA Newsletter.

ii) There is concern that some customers are modifying the form, so that it is no longer ‘standardized’. A memo advising against this practice will be sent out to the CTFA technical committees.

iii) It is recognized that it will take time before suppliers are able to phase in this form for their ingredients, and that the interaction between suppliers and their customers is key to the form’s success.

iv) It was suggested that the form be moved from the members only site on the CTFA website to be more easily accessible and available to non-members. It was also suggested that a memo describing the form and its purpose be posted with the form. LLoretz will follow up.

b) Safety Seminar(s)

i) An updated draft outline for the October 25 Safety Seminar (“New Initiatives & Issues Affecting Cosmetic Safety Assessment Around the World”) was provided to the Committee. This draft was discussed by the Safety Seminar subcommittee by conference call prior to the meeting. Two speakers have been confirmed, and we are awaiting confirmation from several others. The seminar will again be held in Newark, New Jersey.

ii) A Regulatory Science Summit is also being organized by CTFA to take place on September 6-7 in Washington D.C. The program will feature FDA and Industry speakers and will examine the changing regulatory environment and the science of safety substantiation. Topics to be addressed include current safety practices, non-animal alternative assays, and alternative routes to safety substantiation including the Threshold of Toxicological Concern approach.

iii) On June 14, there will be a CTFA Workshop entitled Adverse Health Effects: Managing Reports for Cosmetics & OTC Drugs. The workshop is designed to assist companies establish processes and procedures to implement the Consumer Commitment Code requirement for “computation of the incidents of adverse health effects”.

iv) A number of webinars are also scheduled or in the planning stages. A Nanotoxicology webinar will take place on May 3. A series of “how-to” webinars are planned, with the first one intended to facilitate participation in the Voluntary Cosmetic Reporting Program. SRTC suggestions for additional webinar topics/speakers, and participation in the organization of the programs, would be welcomed.

c) Presentations at SRTC Meetings

i) Following the February SRTC meeting, a speaker survey was sent out to assess interest in various topics/speakers that had been suggested for future SRTC meetings. Results have been circulated (e-mailed April 27).

ii) The topic receiving the highest score was Natural Toxins (emphasis on botanicals). After discussion it was decided to arrange a presentation on botanicals for the July meeting. There is interest in having Tim Adams (FMA) come in to talk about the Naturals Paradigm; another possibility is to have someone from the American Botanicals Council give a presentation. LLoretz will follow up.

iii) There was also interest in Animal Alternatives. CTFA is still working on strategy to address the issue, and will be coordinating closely with Colipa. John Bailey will be asked to update the committee at the July meeting.

d) CTFA Consumer Website

i) SRTC has been invited to provide a scientific review of the ‘In the News’ issues that will be posted on the CTFA Consumer Website. Several members responded to the request for interest that was sent out on April 17. The messages are also being sent to the Website Advisory Committee as part of the established review process, and will therefore be available to SRTC members who are already involved in the website review process. Deadlines continue to be very tight.

3) Emerging Issues

a) Issues Management/Lavender

i) The question of how crisis issues are handled (communication within and between companies and trade associations) was raised. While lavender is the impetus for starting the discussion, the issue is being raised generically rather than specific to any one issue.

ii) A follow-up conference call will be arranged for interested SRTC members. Its purpose will be to come to a collective understanding of typical communication processes, and to brainstorm for future improvements. LLoretz will send out an e-mail to determine interest.

b) Siloxanes/Canada

i) Health and Environment Canada are expected to identify three siloxanes (D4 [cyclotetrasiloxane], D5 [cyclopentasiloxane], and D6 [cyclohexasiloxane]) as needing further assessment for environmental effects in the very near future.

ii) The siloxanes had been identified in September 2006 as substances with “high priority for action” by Health and Environment Canada based on certain assessment criteria. Approximately 200 of the 23,000 substances reviewed were identified as such. These 200 substances have been divided into a number of smaller groups so that they can be released in “batches” for further consideration; the siloxanes are in the second batch.

iii) A meeting of Industry representatives has been organized by the Silicone Environmental Health & Safety Council (SEHSC) to take place May 2. CTFA will attend.

iv) The manufacturers are working cooperatively with the Canadian government and will be providing further data.

c) Cosmetic Safety Assessment in Europe

i) A draft document outlining Colipa positions on safety assessment and product information related to the revision of the Cosmetics Directive has been distributed to the SRTC (e-mailed May 1). The document is under review by the CTFA Task Force on the EU Cosmetics Directive, and the CTFA International Executive Steering Committee.

1) CTFA is working with Colipa on this issue. It has not been decided whether CTFA will be providing input to Colipa, or preparing its own comments. The timelines are extremely tight, with the Commission requesting feedback by May 10.

2) CTFA’s International department would welcome comments from SRTC, which can be provided either through LLoretz, or directly to Francine Lamoriello (Executive VP – Global Strategies).

4) Presentation – IFRA 42nd Amendment

a) Dr. Anne Marie Api (Research Institute for Fragrance Materials) gave a presentation entitled “Implementation of QRA for Dermal Sensitization of Fragrance Ingredients Continues – IFRA 42nd Amendment”.

i) The quantitative risk assessment methodology for sensitizing fragrance materials was briefly reviewed. The QRA approach is an exposure-based risk assessment and uses a weight of the evidence approach to setting No Expected Sensitising Induction Levels (NESILs). NESILs are expressed as dose/unit area, and limits are set based on product categories.

ii) IFRA standards in the 42nd Amendment were reviewed. There are 16 revised Standards based on QRA, and 14 new Standards based on QRA. Four materials have been added to the list of prohibited materials with insufficient data, and there is a reformatted Standard on crude Peru Balsam. The Amendment is expected to be officially released very soon.

iii) IFRA product categories were reviewed, with recent changes noted. Those changes are included in Version 2 of the RIFM/IFRA QRA Booklet, which is part of the 42nd Amendment.

iv) The status of QRA implementation was discussed. A key goal is to review all chemically defined fragrance ingredients with structural alerts for dermal sensitization that are used >1 metric ton per year on a worldwide basis by 2011.

b) Dr. Api’s overheads were distributed to the Committee (e-mailed May 3).

5) Presentation – REACH – Legislative Overview & REACH Strategy

a) Dr. Kevin Renskers gave a presentation on EU REACH regulations (Registration, Evaluation, Authorisation and Restriction of Chemicals; overheads e-mailed on May 3).

i) REACH, which enters into force June 1, 2007, mandates a system to control and manage chemicals throughout the entire supply chain, and consolidates ~40 individual directives and regulations. Cosmetics are exempt from REACH for human health endpoints, but environmental data requirements still apply.

ii) The main elements of REACH were described, and implementation considerations were reviewed. Of most immediate concern is pre-registration for phase-in substances, which begins June 1, 2008, and runs for only 6 months. The Authorization process for “substances of very high concern” was also described.

iii) The fragrance industry has evaluated the impact of REACH on their ~2600 materials and estimates 745 materials fall under REACH (used at > 1 mt/year).The European Flavor & Fragrance Association (EFFA) has developed a roadmap to coordinate implementation of REACH within the fragrance industry. The roadmap includes a timetable of activities and a schedule for registrations, and describes the preparation for REACH registration in 14 sections, each with appropriate activities.

6) Updates

a) Fragrance Issues

i) The IFRA compliance program which tests for the presence of banned materials in product has been formally launched. The initial analyses are complete, although the data are not yet available.

ii) The in-life phase of a reproductive toxicity study with Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (HMPCC, also known as Lyral®) has been completed, and data may be available as early as June. An earlier reproductive/ developmental toxicity study found skin sloughing in pups, although it was not clear if this effect was due to in utero exposure.

iii) A March 2006 opinion from the SCCP reaffirmed a 1 ppm limit on furocoumarins in finished product, which would be expected to eliminate the use of some natural materials. The concern relates to photomutagenicity. A meeting is being set up with DG Sanco and DG Enterprise.

iv) The pilot for the epidemiology study to determine fragrance allergy in the general population is underway in Europe. One hundred subjects are included in each of six locations. The data are expected to be analyzed by June, with the full study to start in fall (2000 subjects/location).

v) A 90-day oral toxicity study with trichloromethyl phenyl carbonyl acetate (also known as Rose Crystals) has started. An oral reproductive/developmental toxicity study will also be conducted. The testing was requested by the RIFM Expert Panel.

vi) The fragrance industry is sponsoring a uterotrophic assay with lavender. The exact material to test is currently being determined. The work is being undertaken in response to a publication in the New England Journal of Medicine which reported an association between 3 cases of gynocomastia in young boys and use of lavender oil.

vii) RIFM is sponsoring a clinical inhalation study comparing the response of non-asthmatics, mild asthmatics, and moderate asthmatics to fragrance exposure. Respiratory function and cytokine formation are the endpoints being evaluated.

viii) NTP has proposed to conduct chronic toxicity/carcinogenicity studies via the inhalation route on diacetyl and acetoin (components of artificial butter flavor).

b) Ingredient Issues Table

i) An updated Ingredient Issues table was distributed before the meeting (e-mailed April 27).

ii) Colipa has requested a meeting with the SCCP to identify further data needs for the straight chain parabens. The design and quality of the previously submitted studies will be defended, and additional metabolism and human exposure studies are being proposed. Separately, a group of suppliers interested in continuing to support the branched-chain parabens has met, and a follow-up meeting is planned.

iii) In response to a request for data from the California Attorney General’s office, the CTFA 1,4-dioxane Task Force has made two submissions addressing exposure from rinse-off and leave-on products. The submissions conclude that 1,4-dioxane exposures are far below the Proposition 65 No Significant Risk Level. 1,4-dioxane is a1so under review in EPA’s Voluntary Children’s Chemical Evaluation Program, with a peer consultation meeting scheduled today (May 1).

iv) NTP has proposed to conduct a two generation reproduction study on diethyl phthalate, in response to a nomination by NIEHS.

c) Animal Alternatives

i) The World Congress on Alternatives will take place in Japan in August.

ii) ICCVAM and NICEATM have released their draft five-year plan that addresses development and validation of new and revised alternative assays, and identifies high priority areas for replacement, reduction, and refinement of animal tests. A meeting to receive public comments on the plan is scheduled for June 11 in Bethesda.

iii) The ECVAM Scientific Advisory Committee (ESAC) has announced the validation of five new test methods, addressing the endpoints of skin and eye irritation, and skin sensitization.

d) CIR

i) Changes to CIR procedures were summarized by CEisenmann.

1) In order to speed up the reviews, the public comment periods have been reduced from 90 days to 60 days.

2) Ingredients can now be added to a report during the re-review process. The potential addition of an ingredient will be announced so that the public can comment and provide data.

3) A representative of the Consumer Federation of American has been added to the Steering Committee.

ii) A CIR Reports Status Table was distributed (also sent via e-mail May 3).

1) The use of thioglycolic acid ingredients in depilatories was discussed at the April 2007 CIR meeting. The Expert Panel concluded that these ingredients could be used if they are formulated to be non-irritating under conditions of recommended use.

2) The CIR Expert Panel decided to re-open the report on cocamidopropyl betaine, and has expressed concern about the sensitization potential in both leave-on and rinse-off products. They requested industry information regarding what limits of impurities (3-dimethylaminopropylamine [DMAPA] and amidoamine) would be appropriate.

3) A scientific literature review is available for the licorice botanicals, and these ingredients are on the agenda for the September meeting.

4) The CIR Expert Panel decided not to re-open the benzyl alcohol/ benzoic acid/sodium benzoate report due to limitations in the latest data that were submitted. The interested party task force is determining whether there is financial support to complete an inhalation study.

e) Carcinogens/Reproductive Toxicants

i) An update on regulatory activities related to carcinogens and reproductive toxicants prepared by JAvalos was distributed to the Committee (e-mailed April 30).

1) California’s Office of Environmental Health and Hazard Assessment (OEHHA) announced that it will establish regulatory levels for ethylene glycol monoethyl ether and ethylene glycol monoethyl ether acetate, with comments due May 14.

2) The Center for the Evaluation of Risks to Human Reproduction (CERHR) will be holding a second meeting of the Bisphenol A Expert Panel.

3) Isoeugenol has been taken off the agenda for the May Technical Reports Review Subcommittee.

f) NGO Activities

i) JBurdick provided an update on the Non-Governmental Organizations Website Monitoring Program conducted by Beauty Avenues. A handout covering the period of February to April 2007 was distributed (e-maile April 30).

7) Adjourn/Set Time for Next Meeting

a) There being no further business, the meeting was adjourned. The next SRTC meeting will take place July 24 in Washington D.C.

Respectfully submitted,

Linda Loretz, Ph.D., D.A.B.T.

Director - Safety and Regulatory Toxicology

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