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Oct. 9 - Czech Republic: REACH Will Be Coming to the Czech Republic After All

October 9th, 2008

According to a recent report:

zech lawmakers Tuesday overrode a presidential veto of a law that puts the country’s chemical industry under tougher European Union rules…

The bill, originally passed by parliament in July, implements an EU directive that requires manufacturers and importers to register chemicals with the new Helsinki-based European Chemicals Agency…

Czech President Vaclav Klaus, a free-market proponent and outspoken EU critic, called the directive, also known as REACH, bureaucratic and bad for business.

Click on the link for more information.

Oct. 7 - US: US to overhaul industrial chemicals inventory

October 7th, 2008

From RSC.org:

A plan by the US Environmental Protection Agency (EPA) to overhaul its inventory of industrial chemicals could lead to a lot more paperwork for chemical firms, industry officials have warned.

The Chemical Substances Inventory, established under the 1976 American Toxic Substances Control Act (TSCA), lists all chemicals manufactured in the US or imported into the country, along with safety data. But only around 7,000 of the 83,000 chemicals currently listed are actually still in use, according to the American Chemistry Council (ACC), a trade group representing North American chemical companies…

The inventory reset initiative is under the auspices of EPA’s Chemical Assessment and Management Program (ChAMP). Through the programme, the chemical industry will also be expected to provide health and safety information on inorganic high-production volume (HPV) chemicals - defined as substances with annual production or import volumes above 1 million pounds (454 metric tonnes).  The initiative will likely be voluntary, but the agency has warned that testing could be compulsory in the absence of ‘timely and responsible action’ by industry.

Click on the above link for more information.

Oct. 7 - EU: Impact of REACHs Very High Concern Candidates

October 7th, 2008

Recently we discussed the 16 candidates for Very High Concern status under REACH.  In European Chemical Clampdown Reaches Across Atlantic Scientific American discusses the possible implications for U.S. companies:

Hundreds of chemicals likely to be identified by the European Union (E.U.) as “substances of very high concern” are produced throughout the U.S., sometimes in large quantities…

These dangerous chemicals have been identified via the E.U.’s 2007 Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) law, which requires the disclosure of all chemicals sold in the E.U. in quantities of more than one metric ton per year. As it stands, 16 chemicals, including three phthalates, are already on the REACH list as chemicals of concern. And in coming years, the REACH law will require that companies prove the safety of a given chemical before it is allowed to be sold; those chemicals deemed dangerous—or “substances of very high concern” due to associated human health risks—will only be sold with special governmental permission.

Of the 267 chemicals on the potential expanded REACH list compiled by the International Chemical Secretariat in Sweden, two are regulated in some form under U.S. law—asbestos and hexavalent chromium (chromium VI)—and only one third have even been tested by the EPA…

All told, the U.S. manufactures more than one billion pounds (455 million kilograms) of 14 potential REACH-listed chemicals, including two varieties of toluene; 85 more are made in quantities exceeding one million pounds (455,000 kilograms), like the phthalates which have already been regulated in some cases in the E.U.

BASF, Chemtura, Dow, DuPont and Equistar make the most of these suspect chemicals in the U.S., and Kentucky, Louisiana, Michigan, New Jersey, New York, North Carolina, Ohio and Texas host operations that manufacture them. Some of the most commonly produced dangerous chemicals include benzene, formaldehyde, styrene, hexane and butadiene…

Another article: How Europe’s New Chemical Rules Affect U.S. discusses the possible impact of the ‘Substitute it Now’ or SIN List:

  • SIN List chemicals are produced or imported in 37 states as well as Puerto Rico and the Virgin Islands, at as many as 78 sites per state…
  • The number of SIN List chemicals per state varies from 1 to 37.
  • Eight states have at least a dozen SIN List chemicals: New Jersey, Texas, Louisiana, Ohio, New York, North Carolina, Kentucky and Michigan.
  • In the United States, at least 85 SIN List chemicals are produced annually in amounts of one million or more pounds, and at least 14 exceed one billion pounds annually.
  • At least 173 companies are producing or importing SIN List chemicals in the United States.
  • Some companies are associated with many SIN List chemicals—as many as 21 per company.
  • The five companies reporting making the most SIN List chemicals are Dow, DuPont, Chemtura, Equistar and BASF.
  • Many SIN List chemicals are produced or imported by multiple companies at numerous sites—as many as 36 companies at 52 separate sites. The five chemicals with the most companies and sites are benzene, formaldehyde, styrene, hexane and 1,3-butadiene.

Click on the above links for more information.

Oct. 7 - Canada: Even More CCCR Recalls

October 7th, 2008

As we mentioned in Health Canada Cracking Down on Non Compliant Labels and in CCCR Recalls Continue a number of products have been recalled for non-compliance with CCCR-2001 and the cosmetics regulations.  Recently two more products, both packaged in “pressurized containers” have been recalled, both for “lack[ing] the symbol and warnings required for potentially flammable and explosive products. The lack of labelling information including appropriate warnings could potentially result in misuse of this product and lead to serious injury.”

The products are:

  • A tanning mist
  • A hair spray

The full set of recalls - available here.

Oct. 1 - Nexreg Presentation for the Southern Aerosol Technical Association

October 1st, 2008

Nexreg is giving a presentation at the Southern Aerosol Technical Association’s annual conference.  Topic of the presentation - Canadian compliance, including issues such as CCCR-2001 and proposed VOC regulations.  For anyone who is interested a copy of the slides is available here.

Sep. 22 - EU: REACH a risk to EU solder supply, warns report

September 22nd, 2008

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.

Sep. 22 - US: FDA Mulls Changes to Allergy Labeling on Foods

September 22nd, 2008

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 .

Sep. 22 - Canada: Two CEPA Updates

September 22nd, 2008

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);
  2. Methyloxirane (CAS No. 75-56-9);
  3. Ethyloxirane (CAS No. 106-88-7);
  4. Naphthalene (CAS No. 91-20-3);
  5. Toluene diisocyanates (three substances: CAS No. 26471-62-5, 584-84-9 and 91-08-7);
  6. 1,2-Benzenediol (CAS No. 120-80-9);
  7. 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.

Sep. 22 - Canada: CAS No. 5977-14-0

September 22nd, 2008

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.

Sep. 22 - Canada: Food and Drug Regulations — Amendments

September 22nd, 2008

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.