Of particular interest in this EETimes.com report is how REACH is still poorly understood by many companies:

A survey has thrown up major concerns that the recently adopted EU REACH (Registration, Evaluation and Authorization of Chemicals ) regulation will disrupt metal and chemical supply to the EU and this could start to cause major disruptions by the end of this year if importers do not begin to take action to deal with the regulation.

The worrying results of the survey, conducted by IPC Market Research, suggest that the majority of solder suppliers have very limited knowledge of the regulations. When asked about awareness and readiness for REACH compliance, most scored a 1 (none) in response to a 10 point scale.

This is a worrying and surprising statistic with less than 3 months for pre-registration under REACH, according to IPC.

Companies may not understand that the implications of not being REACH compliant could lead to exclusion from the EU market, thus resulting in inevitable interruptions in trade.

REACH is expected to impact every company within the EU, especially those depending on non-EU suppliers.

Click on the above link for the full story.

From Health Day News:

Responding to concerns that food labels aren’t doing enough to alert consumers to the presence of allergens, or that the labels are just plain confusing, the U.S. Food and Drug Administration is hosting a public hearing Tuesday on what it can do to improve things.

“If you go down the candy aisle and you pick up any number of candy bars or other confectionery products, you are going to see a variety of these ‘may contain’-type labels: ‘may contain peanuts,’ ‘processed on shared equipment,’ ‘manufactured in a facility that processes peanuts or milk or whatever it is,’” said Anne Munoz Furlong, founder of The Food Allergy & Anaphylaxis Network in Fairfax, Va. “Nobody knows what it means. Some 1/8labels 3/8 are completely ridiculous, and the result is that consumers are confused and are forced to have very limited food choices or take risks.”

“We would like to see all of the food industry adopt one set of criteria for using these descriptions and a limited number of those descriptions,” Furlong added. “There are about 30 different ways to say ‘may contain’ on the marketplace. That’s way too many.”…

The hearings are part of a “long-term strategy” on the part of the FDA to help manufacturers upgrade their labeling practices, making them both clear and truthful…

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) required new labels on packaged foods containing “major food allergens,” which were defined as milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts and soybeans, or any other ingredient that contains protein derived from one of these foods or food groups.

More information available at the above link or from the FDA here .

First update, dealing with chlorinated paraffins, from Canada Gazette:

Chlorinated paraffins refer to three classes of substances: short chain chlorinated paraffins (i.e. chlorinated paraffins with 10–13 carbon atoms), medium chain chlorinated paraffins (i.e. chlorinated paraffins with 14–17 carbon atoms) and long chain chlorinated paraffins (i.e. chlorinated paraffins with 18 or more carbon atoms). In Canada, these substances are mainly used in metalworking, in plastics/rubber and as lubricating additives.

Chlorinated paraffins were initially assessed under the first Priority Substances List program. The assessment report concluded that short chain chlorinated paraffins constitute or may constitute a danger to human health or life as set out in CEPA 1999 (see footnote 1); however, data identified at that time were considered insufficient to conclude whether short, medium or long chain chlorinated paraffins were harmful to the environment or whether medium or long chain chlorinated paraffins were considered a danger to human health. Discussions aimed at managing the risks posed by short chain chlorinated paraffins were engaged with stakeholders under the framework of the Toxic Substances Management Policy. However, risk management discussions were suspended, pending the generation and review of new information concerning the risk of chlorinated paraffins to human health and the environment.

Final follow-up assessment report on chlorinated paraffins

Environment Canada and Health Canada conducted the follow-up assessment report on chlorinated paraffins pursuant to section 68 of CEPA 1999.

The final assessment concludes that

• all chlorinated paraffins meet the criteria under paragraph 64(c) of CEPA 1999; and
• chlorinated paraffins containing up to 20 carbon atoms (short- and medium-chain chlorinated paraffins, as well as liquid long chain paraffins) meet the criteria under paragraph 64(a) of CEPA 1999.

Based on conclusions of the assessment, it is therefore recommended that all chlorinated paraffins be added to the Schedule 1 of CEPA 1999.

Furthermore, chlorinated paraffins containing up to 20 carbon atoms are predominantly anthropogenic and the available data regarding their persistence and bioaccumulation potential indicates that they satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations, made under CEPA 1999. Chlorinated paraffins containing up to 20 carbon atoms thus meet the criteria for virtual elimination (see footnote 2) of releases to the environment as set out in the Toxic Substances Management Policy.

The second update, on a variety of substances, available here:

Chemical substances used in human activity can have detrimental effects on the environment and human health when released in a certain quantity or concentration in the environment. Scientific assessments of the impact of human and environmental exposure to a number of these substances have determined that these substances are toxic to human health and the environment as per section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).

The objective of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the proposed Order) made pursuant to subsection 90(1) of CEPA 1999, is to add the following substances:

1. Propanedinitrile, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino] -2-methylphenyl]methylene]- (CAS No. 54079-53-7);
3. Methyloxirane (CAS No. 75-56-9);
4. Ethyloxirane (CAS No. 106-88-7);
5. Naphthalene (CAS No. 91-20-3);
6. Toluene diisocyanates (three substances: CAS No. 26471-62-5, 584-84-9 and 91-08-7);
7. 1,2-Benzenediol (CAS No. 120-80-9);
8. 1,4-Benzenediol (CAS No. 123-31-9).

to the List of Toxic Substances in Schedule 1 of CEPA 1999. This addition would enable the departments to develop management measures with respect to taking preventive or control actions in relation to these substances.

Click on the links for more information.

Another item of interest in the Canada Gazette:

Whereas the Minister of the Environment and the Minister of Health have assessed information pertaining to the substance Butanamide,
3-oxo-, Chemical Abstracts Service No. 5977-14-0;

And whereas the Ministers suspect that the substance is toxic;

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

Click on the above link for more information.

From the Canada Gazette:

Provision currently exists in the Food and Drug Regulations for the use of allura red, sunset yellow FCF and tartrazine as colouring agents in a variety of food products, including fish roe (caviar) at a maximum level of use of 300 ppm, singly or in combination. Brilliant blue FCF is permitted as a colouring agent in various foods, including fish roe (caviar) at a maximum level of use of 100 ppm, singly or in combination with fast green FCF.

Health Canada has received a submission to permit the use of a blend of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine as colouring agents in lumpfish caviar at a level of 800 ppm. The maximum level of use for allura red, sunset yellow FCF and tartrazine, singly or in combination, would be 550 ppm and the maximum level of use for brilliant blue FCF would be 300 ppm. Evaluation of available data supports the safety and effectiveness of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine as colouring agents in the production of lumpfish caviar.

The use of allura red, brilliant blue FCF, sunset yellow FCF and tartrazine will benefit consumers by increasing the availability of quality food products. It will also benefit industry through more efficient and improved manufacturing conditions.

Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of allura red, sunset yellow FCF and tartrazine as colouring agents in the production of lumpfish caviar, singly or in combination, at a maximum level of use of 550 ppm, and to permit the use of brilliant blue FCF as a colouring agent in the production of lumpfish caviar at a maximum level of use of 300 ppm with a total level of the four colours not to exceed 800 ppm.

Click on the above link for more information.

A REACH update from Electronics Design, Strategy, News:

The EU (European Union) environmental NGOs (non-governmental organizations) through the International Chemical Secretariat has released its “Substitute It Now” (or aptly acronymed “SIN”) list of 220 chemical substances considered to be possible Substances of Very High Concern under REACH (Registration, Evaluation, and Authorization of Chemicals).

As a reminder, REACH began on June 1, 2007, and aims to streamline and improve the former legislative framework for chemicals in the EU. Under REACH, manufacturers and importers must register substances they produce or import in quantities of one ton or more per year per company by end of 2008. These companies may not use any substance that REACH determines to be a Substance of Very High Concern in products unless granted authorization.

Electronics supply chain watchers at Design Chain Associates reported that the SIN list was introduced at a conference held Wednesday in Brussels. The European Chemicals Agency had published a proposed list of 16 substances earlier this month. Design Chain Associates had its director of EU law and policy, Kris Pollet, at the Brussels meeting and reported that the European Chemicals Agency expects the first candidate list to be approved on October 22.

A 5-page PDF of the SIN list chemical substances is available here. The proposed list of 16 substances of very high concern is available here and includes the following:

• Anthracene CAS No. 120-12-7
• 4,4′- Diaminodiphenylmethane CAS No. 101-77-9
• Dibutyl phthalate CAS No. 84-74-2
• Cyclododecane CAS No. 294-62-2
• Cobalt dichloride CAS No. 7646-79-9
• Diarsenic pentaoxide CAS No. 1303-28-2
• Diarsenic trioxide CAS No. 1327-53-3
• Sodium dichromate, dihydrate CAS No. 7789-12-0
• 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) CAS No. 81-15-2
• Bis (2-ethyl(hexyl)phthalate) (DEHP) CAS No. 117-81-7
• Hexabromocyclododecane (HBCDD) CAS No. 25637-99-4
• Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) CAS no. 85535-84-8
• Bis(tributyltin)oxide CAS No. 56-35-9
• Lead hydrogen arsenate CAS No. 7784-40-9
• Triethyl arsenate CAS No. 15606-95-8
• Benzyl butyl phthalate CAS No. 85-68-7

Click on the above link for the full article. Nexreg has more information on REACH at the following link:

• REACH Compliance Consulting

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

Nexreg Toll Free: 1-866-361-3032
Non-Toll Free: (519)488-5126 (London, ON, Canada)
E-mail:info@nexreg.com

An annoucement from Health Canada:

The Licensed Natural Health Products Database will allow Canadians to quickly and easily search for more detailed information on natural health products that have been authorized for sale in Canada…

Canadians will be able to use the database to search for information on approved natural health products including authorized health claims and recommended uses, risk information such as warnings and cautions, and medicinal ingredients associated with the product. It will be updated regularly as more products are licensed.

The database will also help practitioners, pharmacists and Canadians determine which products have been assessed by Health Canada and have found to be safe, effective and of high quality under their recommended conditions of use.

Canadians are also reminded that natural health products that have been authorized for sale are issued a Natural Health Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which appears on the product’s packaging.

The Licensed Natural Health Products Database is available on the Health Canada Web site.

Click on the above link for more information or go directly to the database.

From the Canada Gazette:

The proposed Regulations will add PFOS and its salts to the Virtual Elimination List compiled under subsection 65(2) of CEPA 1999, as required by subsection 3(1) of the Act.

The Ministers of Environment and of Health are required by the Act to propose the addition of PFOS and its salts to the Virtual Elimination List of CEPA 1999. No other alternative is acceptable under the Act.

Perfluorooctane sulfonates are not manufactured in or exported from Canada. However, in the past, they were typically imported as raw chemicals and in products and formulations. An Environment Canada use pattern survey undertaken in 2000 indicated that, from 1997 to 2000, an estimated 318 tonnes of PFOS was used in Canada. The primary uses of these substances were in applications involving water, oil, soil and grease repellents for fabric, leather, packaging and rugs and carpets, for both domestic and commercial use, and as additives in firefighting foams and paints and coatings. Between 2000 and 2002, the primary international manufacturer of PFOS voluntarily phased out its production of PFOS. The use trend in Canada, therefore, significantly dropped since 2002.

Click on the above link for more information.

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.

A useful reminder from Packaging News:

The UN’s Globally Harmonised System (GHS) on the classification, labelling and packaging of hazardous substances is to be incorporated into EU law after MEPs reached an “acceptable compromise”.

The new regulation will replace existing EU directives on classification and labelling of substances.

The aim of the GHS system is to enable products to be judged on their physical hazards and toxicity and to provide them with suitable labelling and information on safety measures, which could be through labels, hazard pictograms and words such as ‘Danger’ or ‘Warning’.

As with the current legislation, the proposed new regulation is intended to be primarily a self-classification system for businesses.

The regulation is in line with Registration, Evaluation, Authorisation and Restriction of Chemicals (Reach) legislation, although “some small amendments” to do with classification and labelling will have to be made.

A Press Release from the EU adds:

The compromise which has been agreed between representatives of the Parliament and the Council, aims to implement the GHS system into EU legislation. The new regulation will replace the existing EU directives on classification and labelling of substances which set forth an extensive system (3 key directives), but the current rules and the GHS are conceptually similar. The proposal aims to maintain the current level of environment and health protection, to keep the scope of the classification and labelling rules as close as possible to the existing EU system and to ensure a smooth transition to a new system based on GHS. The reclassification and labelling of most substances must be completed by 1.12.2010 for substances and 1.6.2015 for mixtures. The current Directives on classification, labelling and packaging will be repealed on 1 June 2015. During a transitory period both systems will be applied.

Click on the above links 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

Relevant Nexreg Compliance Links: Nexreg, EU SDS Authoring, GHS Consulting.