SCCP OPINIONS-Hair Dye Ingredients, Benzophenone-3, Ethoxydiglycol, and Tea Tree Oil

1/15/2009 – SCCP Opinions on 10 Hair Dye Ingredients, Benzophenone-3, Ethoxydiglycol and Tea Tree Oil   (PCPC)
Opinions adopted by the Scientific Committee on Consumer Products (SCCP) at the December 16, 2008 meeting have been posted on the internet at http://ec.europa.eu/health/ph_risk/committees/04_sccp/sccp_opinions_en.htm?e

For 2,2′-Methylenebis-4-Aminophenol HCl, the SCCP concluded that because of the low margin of safety for use in both oxidative and non-oxidative hair dye formulations, this ingredient at on-head concentrations of 2% in the presence or absence of a developer mix poses a risk to the consumer.

 

The safety assessment of Disperse Red 17 was not completed. An additional in vivo mutagenicity test and information on stability was requested.

  Conclusions regarding the other 8 hair dye ingredients considered by the SCCP are shown in the table.

  Ingredient(s)  SCCP Limits  SCCP Comments 

2-Hydroxyethyl Picramic Acid  non-oxidative 2%

oxidative 1.5%  do not use in combination with nitrosating substances; nitrosamine content <50 ppb 

4-Amino-3-Nitrophenol  non-oxidative 1%

oxidative 1.5%  “an extreme sensitiser”; studies on genotoxicity in finished hair dye formulations should be completed 

Acid Yellow 1  non-oxidative 0.2%

oxidative 1%  “a potent skin sensitiser”; stability in oxidative formulations has not been demonstrated 

2-Methyl-1-Naphthol including 1-Acetoxy-2- Methylnaphthalene  oxidative 2% (2- Methyl-1-Naphthol should not exceed 2% when both ingredients are present)  “a strong sensitiser”; studies on genotoxicity in finished hair dye formulations should be completed 

Tetraaminopyrimidine Sulfate  non-oxidative and oxidative 3.4% (2.0% free base)  sensitising potential cannot be excluded; studies on genotoxicity in finished hair dye formulations should be completed 

2-Methylresorcinol  non-oxidative and oxidative 1.8%  studies on genotoxicity in finished hair dye formulations should be completed; the function of 2- Methylresorcinol in non-oxidative hair dyes is unclear 

3-Amino-2,4- Dichlorophenol HCl  non-oxidative and oxidative 1.5%  has sensitising potential; studies on genotoxicity in finished hair dye formulations should be completed 

HC Blue No. 12  non-oxidative 1.5%

oxidative 0.75%  moderate skin sensitiser; do not use in combination with nitrosating substances; nitrosamine content <50 ppb 

 

For Benzophenone-3 the SCCP concluded “that the use of benzophenone-3 as a UV- filter up to 6% in cosmetic sunscreen products and up to 0.5% in all types of cosmetic products to protect the formulation does not pose a risk to the health of the consumer, apart from its contact allergenic and photoallergenic potential.”

 

For Ethoxydiglycol (diethylene glycol monoethylether; DEGEE) the SCCP confirmed use in all cosmetic products (excluding oral hygiene and eye products) at concentrations up to 1.5%. They also concluded that “as a solvent in an on-head concentration up to 7.0% in oxidative hair dye formulations and in an on-head concentration of up to 5.0% in non-oxidative hair dye formulations” the use of Ethoxydiglycol “does not pose a risk to the health of the consumer, provided that the level of ethylene glycol in DEGEE used is <0.2%.” The SCCP noted that the opinion relates to dermal application only and does not include other cosmetic exposure such as exposure from possible aerosol/spray products.

 

The SCCP concluded that the safety of Tea Tree Oil (INCI: Melaleuca Alternifolia (Tea Tree) Leaf Oil) could not be assessed. The SCCP stated that “should there be reliable data on percutaneous absorption covering relevant concentrations and cosmetic formulations, a reassessment of the safety of Tea Tree Oil is envisaged by the SCCP.” They also noted that the cosmetic function of Tea Tree Oil needs to be indicated and that it is a skin sensitizer at current use levels.

 

 

UK-Nutrition and Health claims–Foods

Nutrition claims and Health claims made on Foods – Changes to the CAP Code and launch of the BCAP Consultation

19 January 2009

The Committee of Advertising Practice (CAP), the body responsible for writing and enforcing the non-broadcast advertising code (CAP Code), today publishes changes to the Code to bring it into line with New European legislation on nutrition and health claims made on foods (the NHCR). This is the first piece of specific legislation to deal with nutrition and health claims made on foods and seeks to protect consumers from misleading or false claims. Because the changes reflect the law, they become enforceable immediately.    http://www.asa.org.uk/asa/news/news/2008/Nutrition+and+Health+Claims+Regulation.htm

Good Importer Practices

FOR IMMEDIATE RELEASE January 12, 2009   Media Inquiries:

Christopher Kelly, 301-796-4540

Consumer Inquiries:  888-INFO-FDA

Federal Agencies Issue Draft Guidance for Industry Good Importer Practices

Helping importers ensure their products are safe and comply with U.S. requirements

The U. S. Departments of Health and Human Services, Agriculture, Commerce, Homeland Security, and Transportation and the U.S. Consumer Product Safety Commission, the U.S. Environmental Protection Agency, and the Office of the U.S. Trade Representative today issued draft guidance for industry titled “Good Importer Practices.” The guidance is designed to provide guidance to importers on steps they can take to help ensure imported products are in compliance with applicable U.S. statutes and regulations.  http://www.fda.gov/bbs/topics/NEWS/2009/NEW01941.html

 

FDA Alerts Public about Danger of Skin Numbing Products

FDA News  FOR IMMEDIATE RELEASE  January 16, 2009

 Media Inquiries:  Rita Chappelle, 301-796-4672

Consumer Inquiries:  888-INFO-FDA

 

FDA Alerts Public about Danger of Skin Numbing Products : Serious and life-threatening risks associated with improper use

The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.   http://www.fda.gov/bbs/topics/NEWS/2009/NEW01947.html

Phthalates

Gamete Gamble : Phthalate Alters Germ Cell Development  (EHP, January 2009)

Di-2-ethylhexyl phthalate (DEHP), one of the most abundant phthalates produced, has been incorporated into flexible plastic products such as food containers and packaging, toys, medical equipment, and home and garden products. DEHP is being phased out of some products because of growing concern about its potential health effects. A French team has now established the first tangible link between one phthalate, the DEHP metabolite mono-2-ethylhexyl phthalate (MEHP), and altered human germ cell development [EHP 117:32–37; Lambrot et al.].

The French team acquired testes from morphologically normal fetuses of women undergoing legal abortion during weeks 7 to 12 of gestation. Using an organotypic culture system, they exposed the testes for 3 days to one of three concentrations of MEHP: 10^–6, 10^–5, or 10^–4 M. The highest concentration was 2 orders of magnitude higher than that known by the authors to occur in humans; the lowest was the same order of magnitude as that found in human milk in Finland, which reached 1,410 µg/L. Biomonitoring data for 2005 published by the Centers for Disease Control and Prevention (CDC) showed that MEHP in the urine of U.S. residents reached 52.1 µg/L (or 10^–8 M).

At the highest concentration, the authors found that exposure reduced germ cell numbers by 40%. The sharp reduction occurred via an increase in apoptosis, or programmed cell death, without any effect on proliferation. The authors note that the plunge in numbers is crucial because the germ cells formed during fetal life—which will go on to become ova or sperm—help determine adult fertility.

The highest concentration of MEHP also significantly reduced the messenger RNA expression of anti-Müllerian hormone, which plays a key role in the development of certain cells into male reproductive organs, usually during week 8 of fetal development. The lowest concentration of MEHP tested didn’t show adverse effects for the pathways analyzed.

The general population is routinely exposed to many types of phthalates, with at least one metabolite, monoethyl phthalate, documented in urine by the CDC at concentrations of 10^–6 M. The authors suggest that researchers should investigate additional phthalates and interactive effects, other concentrations and periods of exposure, different time periods of fetal development, and additional pathways. They also note that their findings conflict with some results from animal studies. For instance, there were no MEHP effects on testosterone production in this study, but testosterone suppression has occurred in rats exposed to phthalates. Such discrepancies may be due to differences between species, they say.    Bob Weinhold

Foods and Beverages with Functional Beauty Benefits

Drinking (and eating) to beauty
More popular abroad, foods and beverages with functional beauty benefits are making their appearance in the United States

(Foodbusinessnews.net, January 06, 2009)
by Allison Sebolt

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The quest to find the fountain of youth drove explorers to the Americas, but in today’s world may a tea provide increased energy, stimulate healthy metabolism and restore gray hair to natural color?   http://foodbusinessnews.net/Feature_stories.asp?ArticleID=99001

 

Rebaudioside A

Exclusive Global Strategic Collaboration with Firmenich on All-Natural Zero-Calorie Sweetener for Food & Bevearge Market

PureCircle (LSE:PURE), the world’s leading developer, producer and marketer of high-purity Rebaudioside A (Reb A), the first all-natural zero calorie sweetener, announces today an exclusive global strategic collaboration with Firmenich, the world’s largest privately-owned fragrance and flavour company, to accelerate the commercialisation of Reb-A in the global food and beverage industry.

PureCircle, is the world’s largest supplier of high-purity Reb A which can be used as a key ingredient in mainstream food and beverages.

In December 2008, PureCircle announced that the United States Food & Drug Administration (“FDA”) had issued a no objection letter with respect to high-purity Reb A, formally giving high-purity Reb A Generally Recognised As Safe (“GRAS”) status for use in beverages, foods and tabletop sweeteners, either as a complement to sugar or as a healthy substitute for synthetic sweeteners. The FDA’s response effectively opened the United States, the world’s largest market, for high-purity Reb A to be adopted as a key ingredient in mainstream food and beverage production and across entire product ranges. Food and drink manufacturers in the United States are already using high-purity Reb A as a sweetener ingredient.

Firmenich has developed innovative flavour systems for Reb A, which will be rolled out across food and beverage applications. Under the terms of the collaboration, Firmenich and PureCircle will combine to offer natural flavour and sweetening solutions to category leaders in the global food and beverage market.

Commenting on the collaboration, Magomet Malsagov, Chief Executive Officer of PureCircle, said:

“Health and wellness is at the top of our customers’ innovation agenda as they increasingly respond to consumer demand for healthier food and beverage products. The all-natural and calorie-free sweetener, Reb A, is seen as providing that solution.

“Combining Firmenich’s world class flavour ability and global reach, with the ground-breaking low calorie natural sweetening that Reb A provides, is a major event in the food and beverage industry. Calorie reduction is a major development platform in all key application areas.”

Patrick Firmenich, CEO of Firmenich, added:

“Reducing sugar in food and beverage products, while maintaining consumer preference, is one of the biggest challenges in our business today. By combining PureCircle’s know-how in Reb A with Firmenich’s expertise in sweetness enhancement and flavour masking, I believe that we can fulfil consumer desires for great tasting, low sugar, low calorie foods and beverages.”

ASA–Estee Lauder–TRI-AKTILINE Instant Deep Wrinkle Filler

Estée Lauder Cosmetics Ltd t/a Good Skin Labs

73 Grosvenor Road

London

W1K 3BQ

Number of complaints: 1

                                  Date:   7 January 2009

Media:                   National press

Sector:                   Health and beauty

                                 

                                 

                                 

                                 

                                 

 

Ad
A press ad, for a skin product, stated “NEW! TRI-AKTILINE Instant Deep Wrinkle Filler. Immediately: 68% of subjects reported a visible filling of wrinkles. After 4 weeks of continued use: 83% reported improvement in the appearance of lines. After 8 weeks of continued use: clinical studies measured a 45% visible reduction in wrinkle depth and length.” Further text, underneath the image of a woman with lines around her eyes and mouth marked out, stated “Start to see your wrinkles disappear – INSTANTLY!”.   http://www.asa.org.uk/asa/adjudications/Public/TF_ADJ_45542.htm

China–Labeling–Cosmetics

Cosmetic Companies Must List Ingredients in China:  New law to go into effect in June, 2010.   2009-01-07 | 08:30

The Beijing Drug Administration (BDA) has issued a directive that will require Chinese-made as well as imported cosmetics to list all their ingredients. Products that do not meet this requirement will be suspended from the market in China. The requirement will give consumers information about whether a product contains lead, pigments, mercury and other questionable ingredients.

According to a directive from the BDA, beginning in June 2010, both Chinese-made and imported cosmetics should be marked with all their ingredients and products that fail to meet the requirement will be suspended from the Chinese market.

From then on, consumers will be able to know all of the contents of a cosmetic product, including lead, mercury, and pigments—this information was not always available on cosmetic labels in the past.

A representative from the BDA told local media that, generally speaking, cosmetics manufacturers are willing to mark the nutrients in their products like vitamin C, vitamin E, ginseng, and aloe. But labels do not show some auxiliary ingredients such as preservatives, pigments, flavoring essences, surfactants, and anti-corrosion fungicides.

A relevant regulation of the European Union says that even though not all the contents can be marked on the ingredient list for trade secret reasons, the manufacturer must hand in an application for confidentiality to the supervisory authority. However, when those international cosmetics brands are sold in China, their Chinese instructions are usually curtailed.

Commenting on this situation, the BDA says that cosmetics companies are currently changing their packaging and instructions to meet the new requirements in China. The adjustments would be completed before June 2010 and the sales of products that failed to meet the new policy would be prohibited at that time.

The administration added that the new rule would serve to enhance the rights and interests of consumers while assisting supervision by the departments concerned.

Chitin-Glucan

Study Shows Moisturizing Properties of Chitin-glucan Ingredient  Posted: January 12, 2009

New research supports the use of a biopolymer duo in moisturising and anti-aging products.

Belgium-based company KitoZyme has performed a number of trials investigating the potential of its chitin-glucan ingredient in skin care products. Chitin-glucan is a copolymer found in the cell wall of several fungi, including Aspergillus niger, the source of KitoZyme’s ingredient.   http://www.skininc.com/skinscience/ingredients/37436859.html