MAY 2009
“Free from ...insert your scary story here...”
Using terms such as “contains no...” or “free of...” misleads consumers into believing the ingredient safety is questionable, when scientific evidence may show the ingredient is safe. Chris Flower of the CTPA, a UK cosmetic trade association provides this example, “in the case of parabens, we feel that people are trading on the false allegations of safety concerns.”
Claiming a product is “paraben-free” suggests to consumers that paraben containing products are unsafe, when in fact parabens have a long history of safe use. Such marketing tactics are also designed to imply that the replacement ingredients are safer and better. click to read more
The CTPA says, “We strongly suggest that safety shouldn’t be used as a route to commercial benefits, as it suggests the other products are inherently unsafe. We are all required to provide safe products and this kind of practice undermines the industry as a whole.”
In the same article Cosmetics design-Europe.com reported that France’s regulatory body responsible for “competition and fraud control” concluded that drawing attention to the absence of certain preservatives in cosmetics can mislead the consumer.
Source: www.cosmeticsdesign-europe.com
APRIL 2009
Fear and Politics Trumps Science and Rational Thinking
Despite recommendation by scientists at the Consumer Products Safety Commission (CPSC) which regulates toys, Congress recently implemented a ban on the use of phthalates in all children’s toys. The Consumer Product Safety Commission opposed the ban because “there was not a risk of injury to children” according to Dr. Marilyn Wind of the CPSC. This conclusion was reached after studying phthalates in toys for more than 25 years. This extensive study included toys which are used as teethers and pacifiers. Scientists at the CPSC believe children were not exposed to even a slight risk from products containing these chemicals. click to read more of this article
Scientists at the FDA reached the same conclusion and reported to Congress that a ban was not necessary to protect the public. Unfortunately lawmakers such as Senator Dianne Feinstein (D-CA) and Representative Jan Schakowsky (D-IL) were easily duped by advocacy groups into believing that these ingredients are linked to reproductive toxicity, despite evidence to the contrary presented by two different groups of government scientists.
A favorite tactic used by advocacy groups is to link their demands to “children”, knowing this will pressure politicians to easily give in, rather than stand up for what is right. Activists regularly and successfully use the “children card” to pressure politicians into making decisions that are contrary to science and reason.
Even so, Dr. Wind stands by the results of the government research, “I know we did really good science and sometimes people don’t listen to the good science.”
Source: www.npr.org
MARCH 2009
Cosmetic Labeling Violations Reported in Canada
A media investigation by the Canada’s CanWest News claims to have found many problems with cosmetic products found on store shelves. They also claim that some of the products with labeling violations came from large companies. The most common violations were:
- Ingredients not listed using their proper INCI names.
- Inappropriate cosmetic claims, e.g. “reverses wrinkling”.
- Warning symbols too small/too far apart/too light in contrast to the packaging.
- Incomplete bilingual labeling.
When questioned, Health Canada told reporters only a small proportion of cosmetic products contain “labeling violations” and that these were minor and presented at very low risk to the health and safety of consumers.
Mike Patten from the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) reaffirmed, “We do not believe there is significant non-compliance as outlined in the article. Retail outlets are regularly inspected by Health Canada and we generally only hear of smaller in frequent uses of non-compliance.”
Source: www.cosmeticsdesign.com
FEBRUARY 2009
CIR Expert Panel Continues to Grow and Improve
Cosmetic Ingredient Review Expert Panel (CIR) adds two distinguished chemists to fill newly created positions on this prestigious panel, expanding it from a group of seven to nine world-class experts. The CIR is an independent body that conducts extensive searches of the scientific and medical literature, compiles the data, then reviews the information and often asks the cosmetic industry to provide additional safety testing data before completing their rigorous review process. The hundreds of highly detailed safety assessments developed by the CIR are relied upon by government regulators, manufacturers and non-government organizations (NGO) to assist in determining which substances can be safely used as cosmetic ingredients and which should not be used Two additional experts will allow the CIR to draw from a wider and deeper pool of knowledge and experience when determining the safety of cosmetic ingredients.
The new members are:
Dr. Ronald Hill - an Associate Professor of Medicinal Chemistry at the University of Louisiana at Monroe. Dr. Hill received his PhD in Medicinal Chemistry from Ohio State.
Dr. R. Daniel Liebler - Director at the Jim Ayers Institute for Pre-Cancer Detection and Diagnosis and a Professor of Biochemistry and Pharmacology at Vanderbilt University School of Medicine. Dr. Liebler is also a member of the National Advisory of Environmental Health Sciences Council.
Source: Cosmetic Ingredient Review website
JANUARY 2009
Notable Quotes
On cosmetics:
“I think it’s incorrect to say we are self-regulated. The FDA sets out
standards for how our products can be put together.”
John Hurson, Personal Care Products Council.
Source: The Rose Sheet
Pharmaceutical Giant Sees Opportunity in Beauty Industry
A drug that Allergen Pharmaceutical sells to people with certain types of glaucoma and ocular hypertension has shown some very unusual side effects. The drug contains an ingredient called “bimatoprost” that unexpectedly and quite effectively stimulates the growth of eyelashes. Allergan has decided to introduce a bimatoprost containing product called “Latisse” targeted to consumers who want longer, thicker eyelashes. Classified as a drug and with reams of data showing clinical effectiveness, Latisse is sure to set the gold standard in a category that was previously dominated by cosmetic products.
click to read more of this article
As a result, it’s likely that many pharmaceutical companies will be closely watching to see if Latisse is successful. This may serve as a model for other pharmaceutical companies wishing to create products designed to solve problems previously addressed by cosmetics. Since cosmetic products and ingredients are prohibited by law from affecting the structure and or function of the human body, this regulatory barrier may create an extremely profitable niche for pharmaceutical companies in the future.
Markwins Recalls Lip Gloss Product
The U.S. Consumer Product Safety Commission announced a voluntary recall of about 75,000 Markwins lip gloss keychains. The reason for the recall is due to a metal clasp attached to the keychain contains high levels of lead. Lead can cause adverse health effects if ingested by young children. The lip products are being recalled have been sold at Rite Aid, Kmart, Fred Meyer and Wal-Mart Stores nationwide since October 2008.
New Labelling Rules for Carmine and
Cochineal Extract Colorants
All products containing carmine and cochineal extract must now declared this ingredient on the package label under a new Food and Drug Administration (FDA) ruling.
The FDA has revised its requirements for these color additives in response to reports of moderate to severe allergic reactions toward cosmetics and foods containing carmine and foods containing cochineal extract. The FDA said cosmetics containing carmine must specifically declare the presence of carmine “prominently and conspicuously at least once in the labelling.”
Example: "Contains carmine as a color additive."
The FDA stated “will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives.”
click to read more of this article
The colorants are derived from the female cochineal beetles and are considered safe for use by the general population and are presently used in a wide variety of products other than cosmetics; including ice cream, yogurt, fruit drink, alcoholic beverages and candy. These colorants add a characteristic pink, red or purple color.
The new regulation is effective 24 months after date of publication (January 5, 2009). Voluntary compliance is expected and recommended. If you have concerns, objections or requests for hearing can be submitted for up to 30 days after date of publication.
More info on the FDA website: http://www.fda.gov
NOVEMBER 2008
New Book available on EU Cosmetic Safety
Safety Assessment of Cosmetics in the European Union (S. Karger) is a new book available from Dermato-Cosmetic Sciences. This book deals with many aspects of cosmetic safety assessment, including an overview of the EU legislation on cosmetics, SCCP safety assessments, searches for toxicological data in databases and the challenges of applying alternative methods in safety assessments.
More info: dercoscourse.vub.ac.be
OCTOBER 2008
Progress Report: International Cooperation of
Cosmetic Regulation (ICCR)
Substantial progress is being made toward establishing a system of globalization for cosmetic regulations. The group working to achieve this important goal is called the International Cooperation on Cosmetic Regulations (ICCR).
More Info: A progress update can be found at www.hc-sc.gc.ca/
JULY 2008
CTTFA Exploring Siloxane Question
The Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) held a meeting with the Environment Canada scientists responsible for drafting the reports pertaining to three cyclic siloxanes (D4/D5/D6). These three are cosmetic ingredients used widely in many common products used around the world, including shampoos, hair conditioners and skin products. The goal of the CCTFA meeting was to discuss the preliminary draft conclusions concerning the potential for “persistence and bioaccumulation” of these ingredients in the environment. Although most scientists recognize these ingredients as safe for human use, Environment Canada (and others) is currently investigating their fate once released into the environment. If it is determined that these ingredients persist or accumulate, then further steps will be required to determine the environmental risks to the environment. These ingredients could then potentially be labeled as environmental risks (CEPA Toxic).
click to read more of this article
The CCTFA is playing a leading role representing the cosmetic industry to Environment Canada. CCTFA president, Darren Praznik, has listed this as one of his top priorities. A decision is not expected to be reached before the end of this year. It is possible that more information will be requested and the review process may continue well into 2009. Presently, both the US and EU are conducting similar studies, but these will not be concluded before mid-2009.
Main Source: Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA)
JUNE 2008
Tests reveal lead in lipsticks at safe levels
In response to media reports of high levels of lead in lipstick, Health Canada tested lipsticks sold in Canada and the agency confirmed levels do not pose any health risk consumers. Further proof that the Campaign for Sale Cosmetics got it wrong in their report!
The Canadian government decided to challenge the claims made by U.S. group Campaign for Safe Cosmetics and their report last October titled "A Poison Kiss: The Problem of Lead in Lipsticks." This report erroneously suggested there were dangerous levels of lead in lipstick products, a rumor that has come and gone over the years. click to read more of this article
Twenty-one of 26 samples tested at Health Canada's product safety laboratories contained lead levels of 0.079 to 0.84 parts-per-million (ppm), less than 1 ppm. The highest lipstick sample had 6.3 ppm, while the remainder contained no detectable levels of lead, at all. Well within safe levels. Studies performed in the US confirmed these results and has come out with similar opinions. As of this writing, no government health agency in the US or Canada is supporting or verifying the Campaign for Cosmetics conclusions that lipsticks contain unsafe levels of lead.
Main Source: Health Canada
MAY 2008
The FDA Globalization Act of 2008
The U.S. House Committee on Energy and Commerce is proposing legislation entitled “The FDA Globalization Act of 2008.” The legislation intent is to stimulate discussion about ways to provide adequate funding for the FDA and contains several provisions that are sure to impact the cosmetics industry. The most important changes related to cosmetics would be:
1. All US or foreign facilities that manufacture, warehouse or import cosmetics for sale in the U.S. will have to register annually with the FDA and pay a $2,000 per facility registration fee (subject to annual increases).
2. All cosmetic manufactures will have to register their products with the FDA and will be required to file adverse event reports.
3. All cosmetic facilities would be required to comply with Good Manufacturing Practices (GMP) established by the Secretary of Health and Human Services.
4. All cosmetic importers would be required to register annually with the FDA and pay a $10,000 registration fee.
More Info: energycommerce.house.gov
JANUARY 2008
REACH Update
REACH legislation is evolving all the time, as is its effect on our industry. Big changes will be coming over the next few years, so make sure to keep up to date. REACH applies to all chemicals that are marketed or manufactured in the European Union, with few exceptions. click to read more of this article
Cosmetics, beauty and personal care products are considered to be "preparations", and each preparation imported in greater than 1 ton metric per year must be registered by either the EU manufacturer or importer. If any ingredient found in such preparations is not registered (and exceeds the threshold limit), the importer into the EU is responsible for registration. The importer must be a naturalized or legal person established within the EU and responsible for the importation and adherence with all REACH obligations (called an "only" representative).
The only exemption for cosmetics and personal care products from REACH obligations is that MSDS for these products are not required to be provided to the consumer, but will be required by those who use these products in a professional setting, i.e. salon or spa.
REACH regulation implementation is scheduled to take place over the next 10-15 years.
June 1, 2007 – new Safety Data Sheets (SDSs) must be prepared according to the new REACH format.
December 1, 2008 – manufacturers and importers must have pre-registered all chemical substances.
December 1, 2010 – manufacturers and importers must have registered phasing substances over 1000 metric tons/per year plus "CMR substances" and "toxic substances" over 1 ton per year.
December 1, 2013 – manufacturers and importers must have registered "phase in" (not pre-registered) substances over 100 metric tons per year.
December 1, 2018 – manufactures importers must have registered "phase-in" substances over 1 metric ton per year.
Source: http://www.eco-forum.dk/detergents/index_files/Page1963.htm
Tougher Regulations for Cosmetic Products in Asia
In Singapore, the Health Sciences Authority (HAS) introduced tougher regulation for cosmetic products beginning January 1, 2008 under the Asean Cosmetic Directive (ACD) with the goal of promoting higher standards for safety and quality. Going forward, all cosmetic products, toothpastes, soaps, shampoos, make up and perfume will be regulated under the Health Products Act, instead of the Medicines Act. Companies must notify the HAS of all cosmetic products regardless of their product category.
click to read more of this article
The ACD is also calling for an expanded list of prohibited substances, as well as, permitted additives and detailed labeling to include information on ingredient-related precautions. Manufacture and expiration dates, as well as, handling precautions must also be listed. Fines of up to $100,000 and possible jail sentences are levied against those found guilty of adulterating products, using banned ingredients and/or preservatives.
More info: www.business.gov.sg
DECEMBER 2007
Informative, New Cosmetic Safety Website Goes Live
A new website has launched: one that provides and in-depth look at cosmetic and personal care product safety. The site is sure to be very useful for consumers. CosmeticInfo.org is an extremely well-designed website that will be useful for locating safety and health information on beauty, cosmetic and personal care products and ingredients. It reviews 13 product categories and more than 1500 ingredients. The site is certainly worth checking out. Please share the link with others www.cosmeticsinfo.org.
Cosmetic, Toiletry & Fragrance Association (CTFA) changes
its name to "Personal Care Products Council" (PCPC)
The PCPC (previously CTFA) is a beauty, cosmetic and personal care of association comprised of more than 600 member companies. They changed their name in November, 2007, but this organization continues to focus on providing easy to understand, science-based information for consumers, scientists, manufacturers and the media.
More info: www.PersonalCareCouncil.org
NOVEMBER 2007
China's Cosmetic Blacklist
The Chinese Ministry of Health blacklisted 10 domestic cosmetics alleging that they contain ingredients which discolor and injure skin. The ingredient "dexamethasone" initially shows beneficial improvement to skin but over time can cause it to become thin, dry and develop rashes. The ingredient was found in nine types of lotions, essences and masque produced by Gelamei Cosmetics Co., LTD. The Chinese government pledges to continue cracking down on ingredients and products it deems to be potentially harmful to consumers.
Source: www.theRoseSheet.com
FDA and European Commission to Work More Closely
on Animal Testing Alternatives
An agreement struck between the FDA and EC will allow better coordination between these two groups so they finish the peer review validation of alternative animal tests for cosmetics and personal care products. The agreement reached on November 9 at the Trans Economic Council meeting will help speed up the process, which is especially important since the EU ban on animal testing for cosmetic products is set to go into effect in 2009 as required by the 7th Amendment to the EU's Cosmetic Directive.
Presently, there are not enough validated tests to replace animal-based testing and a bilateral effort is needed to ensure effective validation and acceptance of alternative testing methods that have already been created. Source: www.CosmeticsDesign.com
U.S. House of Representatives Fails to Develop
Nanotech Safety Research Plan
A subcommittee chaired by Representative Brian Baird has failed to develop a detailed plan for assessing the environmental and health impact posed by nanotechnology. "I am generally puzzled why more progress has not been made to develop this research strategy... necessary for successful development of nanotechnology." click to read more of this article
At the hearing, the project's chief science adviser Dr. Andrew Manard stated, "the federal government's current approach to ensuring the development of responsible and successful nanotechnologies falls short of the mark."
Activist groups are calling for more research to be funded and propose a 10% increase in the National Nanotechnology Initiative (NNI) budget. Clayton Teague, Director of the National Nanotechnology Coordination Office says, "I am highly confident that the forthcoming NNI EHA Research Strategies will provide the needed framework for the development and support of research programs that provide new knowledge as needed for risk assessment and risk management regarding the use of nanomaterials."
Source: www.theRoseSheet.com
OCTOBER 2007
Global Cosmetic Harmonization: Will it Become a Reality?
A gathering of regulatory organizations and trade associations in Brussels (September 26-28) could lead to regulatory harmonization in the beauty, cosmetic and personal care industry, at least that's the goal of the "International Cooperation on Cosmetics Regulations" (ICCR). Topics under discussion include good manufacturing practices, animal testing alternatives, ingredient regulations and nanotechnology. Participants claim the meetings were productive and this group will gather again soon in the United States, sometime before mid-2008.
View the meeting report at www.cfsan.fda.gov
Source: www.cosmeticsandtoiletries.com
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