The Financial Times has a general interest article on cosmetic product regulations across the world. Since the article is for a general audience, it does not get into details, but it does provide any interest overview of the issues cosmetics companies have when trying to go ‘international’:

There are four principal regions for cosmetics legislation – the EU, the US, Japan and Canada – and the regulatory frameworks differ significantly between them. To a certain extent, these differences act as a barrier to trade, since products must be tailor-made for specific markets on the basis of the regulatory process, which is not always the same as using the basis of safety concerns or consumer preference.

This affects the competitiveness and economic viability of the industry. The inability to sell similar products across all markets, or the requirement to change test methods, formulations, packaging and advertising, can increase costs for the manufacturer. Delays and high costs associated with the introduction of new ingredients and products can also reduce the potential for market growth. With contrary rules governing what is essentially a global business (the EU cosmetics industry output is estimated at €40bn {$57bn}, and international companies account for more than 80 per cent of cosmetics production here), it is the beauty companies themselves that have to rationalise their approach.

“Generally, we try to formulate for the global market,” says De Stasio. “For example, if a substance such as butyl phthalate (used in nail polish) is illegal in the EU but nowhere else, we will avoid using that particular chemical.” For the Asian market, where there is a demand for skin-whitening products, L’Oreal eschews the use of hydroquinone, which is prohibited in cosmetics in the EU and US. Instead, Kojic acid, a skin-brightening mushroom, is the active ingredient in the company’s White Perfect range, sold in Asia…

Still, clearly international alignment would help the global beauty market, encourage innovation and ensure consumer safety. It’s worth noting that the emerging markets of the Middle East, Asia and Eastern Europe are currently basing their approach on the EU model of cosmetic regulation.

Click on the above link for more information.

From Safety.BLR.com:

This year, the United Nations will be implementing the Globally Harmonized System of Classification and Labeling of Chemicals (GHS)–a new global system that will standardize definitions, data sheets, classification of materials, and labeling around the world. U.S. agencies will be making decisions about adopting these requirements in the U.S.

While this is ultimately good news for all concerned, in the short term the implementation of the GHS will require changes in all American workplace hazard communication programs–including all new labels and safety data sheets…

Here is a timeline of OSHA regulatory activities regarding GHS…

• Goal for publishing the proposed rulemaking is October 2008.
• Final rule could be published 12 months to 18 months after that.
• Compliance is likely to be phased in over several years.

Click on the above link for more information.

Nexreg has more information on GHS at the following link:

• GHS Strategic Planning (English)

To speak to a Nexreg representative about how GHS will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

The Guardian has a fairly standard article on the burden REACH is placing on companies. One interesting discussion is the number of pre-registrations that have been sent in:

Dancet’s agency has around 200 staff and aims to add an additional 50 before the year end to handle the flurry of enquiries and pre-registrations that will have to be submitted before 1 of December this year.

“There are enormous numbers of questions coming to our helpdesk … it has been a rather difficult issue to manage over the past year,” Dancet told Reuters in an interview.

Already some 40,000 pre-registrations have been submitted and Dancet expected some 150,000 to 200,000 before the year end.

“We will discuss with our network of national helpdesks how to tackle the continuing increase of questions — potentially it will only get worse,”

Click on the above link for more information.

An announcement from the FDA:

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Labeling OTC Skin Protectant Drug Products.'’ This guidance provides recommendations on how to label over-the-counter (OTC) skin protectant drug products. An OTC skin protectant active ingredient can be combined with another OTC skin protectant active ingredient or OTC external analgesic, first aid antiseptic, or sunscreen active ingredients. Each of these combinations has specific labeling requirements, and therefore labeling of OTC skin protectant drug products is complex. This guidance is designed to clarify the permitted combinations of active ingredients along with the corresponding required labeling.

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 3, 2008.

Click on the link for more information.

We have been telling everyone that would listen that we expected to see a rise in Health Canada actions against non-compliant products. Our predictions appear to have been correct - in July there have already been 3 product recalls of consumer chemical products due to incorrect hazard labelling and packaging. In the 6 prior months of 2008, there were exactly 2. The full list of product recalls is available here. The product types were as follows:

• July 2008 - Spray on Foundation - Label lacked necessary hazard symbols and text
• July 2008 - 6 Liquid Dish Soaps - Labels lacked necessary warning symbols and text
• July 2008 - Aerosol Hair Product - Label lacked necessary warning label
• May 2008 - 7 Home Fragrances - Label lacked necessary warning label
• April 2008 - Fabric Cleaner - Container lacked child safety cap

If you are have any doubts about the compliancy of your chemical products, please do not hesitate to contact us. More information about our label review services can be found here:

• Canadian Consumer Label Review
• Canadian Industrial Label Review
• Canadian Cosmetic Product Label Review

We can be contacted at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

We were browsing through Canada’s Consumer Products Recall list and were struck by the diversity of products being recalled due to excessive lead content.  By our count, 27 products have been recalled in 2008:

• July 2008: Craft kits
• July 2008: Chalk facial mask
• July 2008: Bracelets, Necklaces and Phone Charms
• July 2008: Necklaces and Shoe Charms
• June 2008: School Magnets
• June 2008: Pyjama Sets
• May 2008: Sleeping Bags
• May 2008: Toy wand
• May 2008: Shaker Instrument
• May 2008: Jewellery and Purses
• May 2008: Children’s Storage Bins
• May 2008: Lapel Pins
• April 2008: Fake Teeth
• April 2008: Toy Puzzle
• April 2008: Writing Pens
• April 2008: Metal water bottles
• April 2008: Locks
• March 2008: Bicycles
• March 2008: Wire Bound Journals
• March 2008: Patio Sets
• March 2008: Metal Jewellery
• February 2008: Bracelet Sets
• February 2008: Push-Pin Badges
• February 2008: Sketchbooks
• February 2008: Shoes and Sunglasses
• January 2008: Infant Sleeper and Bootie Sets
• January 2008: Lamps

From the Sacramento Bee:

At the national level, the U.S. Department of Agriculture is working on a definition of “natural products” to be used in future standards, said USDA National Organic Program spokesman Billy Cox. It does not certify natural products.

The department’s National Organic Program certifies organically produced cosmetics and body care products but on a voluntary basis.

The Food and Drug Administration can take action against cosmetic companies that make false or misleading claims on product labels, but it does not define or regulate “organic” or “natural” cosmetics, nor does it test any cosmetics before they go to market.

In the private sector, the nonprofit Natural Products Association launched a certification program May 1. The voluntary program will certify products as natural if they contain at least 95 percent ingredients from renewable resources found in nature, with no petroleum compounds.

For more information, click on the above link.

But not for consumer products, according to a recent article:

The classification and communication of chemical hazard labelling will be implemented in the industrial and agriculture sectors apart from consumer products by 2010, said Deputy Human Resource Minister Datuk Noraini Ahmad…

“Unlike in the European countries, Malaysia was a bit slow in implementing the GHS because it had to be carried out in stages and with the agreement of the other nine Asean countries,” she told reporters after opening the two-day Chemical Management at the Work Place Seminar here Wednesday…

Noraini said after the implementation of the GHS, all imported products would be uniformly labelled and classified to facilitate their usage in the chemical industry. “For example, the chemical elements in imported hair shampoos sold in Malaysia were not uniformly labelled and unclear because of the differences in labelling definitions, thus they needed to be harmonised,” she said.

Click on the top link for the full article.

Nexreg has more information on GHS at the following link:

• GHS Strategic Planning (English)

To speak to a Nexreg representative about how GHS or REACH will impact your company, please call or e-mail Nexreg at:

Nexreg Toll Free: 1-866-361-3032
E-mail:info@nexreg.com

From CosmeticsDesign.com:

The Indie Beauty Network has hit out against the FDA Globalization Act claiming that the proposed legislation will cripple small cosmetics manufacturers.

One of the key sticking points for these companies is the requirement to register products and ingredients annually with the FDA and stump up a significant sum of money for the privilege…

In a video broadcast, Johnson said the draft FDA Globalization Act imposes fees of up to $12,000 a year just for the privilege of selling so much as a bar of soap or a quarter ounce tube of lip balm.

Click on the above link for the full story.

More information about the act can be found here, including a PDF of the discussion draft of the act, which is available here and a PDF of a section-by-section analysis of the act, available here.

The new environmental guidelines we mentioned earlier in the week have been released. A press release from the competition bureau states:

Environmental Claims: A Guide for Industry and Advertisers addresses a number of commonly used green claims and provides examples of best practices on how such claims can be used by businesses to comply with the false or misleading provisions of the laws enforced by the Competition Bureau. Among other practices, the Guide states that:

• The use of vague claims implying general environmental improvement are insufficient and should be avoided.
• Environmental claims should be clear, specific, accurate and not misleading.
• Environmental claims should be verified and substantiated, prior to being made.

…The Bureau recognizes companies may wish to reassess their advertising and labelling in light of the Guide. A one-year transition phase will allow legitimate businesses to change their marketing practices, if necessary, and will also allow the Bureau and CSA to raise awareness and understanding on the new environmental guidelines.

During this one-year transition period, the Bureau will not hesitate to pursue egregious cases of deceptive environmental claims.

Although the Guide is not law, following the best practices outlined will help businesses to avoid making misleading claims that contravene the laws enforced by the Bureau. The Guide will be used by the Bureau to assess environmental advertising that raise concerns under its legislative mandate.

Click on the above link for the full press release.

We highly encourage our colleagues and clients to ensure that their labels comply with the guidelines. A PDF copy of the guidlines is available here (PDF).