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Regulatory News

Jul 31 – Prop 65: Extension of the Public Comment Period (Gallium Arsenide)

July 31st, 2007

A recent release from the OEHHA: Extension of the Public Comment Period on the Proposed Listing of Gallium Arsenide as Known to Cause Cancer and Hexafluoroacetone, Nitrous Oxide and Vinyl Cyclohexene Dioxide as Known to Cause Reproductive Toxicity

On June 15, 2007 the Office of Environmental Health Hazard Assessment (OEHHA) published a notice in the California Regulatory Notice Register (Register No. 2007, 24-Z) announcing its proposal to add gallium arsenide [CAS No. 1303-00-0] to the list of chemicals known to the state to cause cancer, and hexafluoroacetone [CAS No. 684-16-2], nitrous oxide [CAS No. 10024-97-2] and vinyl cyclohexene dioxide [CAS No. 106-87-6] to the list of chemicals known to the state to cause reproductive toxicity, for the purposes of Proposition 65. The June 15 notice announced a July 16, 2007 public workshop and initiated a 30-day public comment period which was scheduled to close on July 16, 2007. OEHHA received a request to extend the comment period to allow for the submittal of relevant information. OEHHA hereby extends the public comment period to 5 p.m., Wednesday, August 15, 2007.

The full release is available here.

Jul 19 – Are you ready for REACH?

July 19th, 2007

Interesting article from The Manufacturing News. Here are some of the hilights:

REACH applies to EU chemical manufacturers and importers of chemicals into the EU. It also applies to “downstream users” that manufacture or assemble products containing chemi-cals that may be physically released and that are sold into the EU market. Everything from pens to perfumes to paint; minerals to household cleaning products may be affected. Products that release chemicals during normal use or just from simple wear and tear, such as tires or even clothing that release dyes when cleaned, may also be covered. Industries ranging from textiles to electronics to housing products will come under the scope of the new rules…

Evaluating your exposure: In order to understand your exposure to REACH and its potential impact on your business, you need to know (1) what chemicals do you use; (2) how you use them (i.e., process chemicals, product ingredients, coatings, etc.); (3) the source of the chemicals; (4) where the chemicals end up (i.e., in products, released from products due to wear and tear or other releases, in wastes, water discharges, etc.); and (5) what markets you sell into. With this baseline set of information, you can begin the process of evaluating how REACH may affect your business, ranging from threats to the availability of key chemicals to revising product formulations to anticipating likely customer demands and needs.

The full article provides an excellent primer on REACH and is available at The Manufacturing News.

Jul 19 – ANSI Conference To Address Social, Economic, And Environmental Impact Of Chemical Regulations (REACH, GHS)

July 19th, 2007

ANSI is hosting a conference in Baltimore, MD that we are sure many of our clients would be interested in. We have been hearing a great deal of anxiety about the potential impact of GHS and REACH regulations:

Global manufacturers are facing increasing pressure to balance the economic and societal impact of domestic and foreign chemical controls such as REACH, RoHS, WEEE and GHS.

On August 9-10, the American National Standards Institute (ANSI) will host Action and Reaction: Developing a sustainable approach to emerging chemical issues, in Baltimore, MD, to engage participants in solutions-focused discussions that bridge regulatory requirements with sustainable manufacturing practices.

“From textiles and pharmaceuticals to electronics and automobiles, chemicals are used in every industry,” explained Dr. Nina McClelland, former chair of the American Chemical Society and chair of the conference planning committee. “The impact is all encompassing. Chemical issues span research and development, production, supply chain and security, energy efficiency, sustainability (green chemistry), and waste management.”

The release is available here. Registration closes July 27.

Jul 19 – Court Rejects Citizen’s Bid for Auto Paint Warnings (Prop 65)

July 19th, 2007

Bondo Corp. has been successful in preventing a Prop 65 warning being placed on some of their products:

A state appeals court in San Francisco today rejected a Bay area man’s legal bid to force a manufacturer to label automobile touch-up paint with a warning of alleged chemical hazards.

The court upheld an Alameda County Superior Court judge’s finding that the danger posed by the paint was so low that the manufacturer was exempted from a state law requiring warnings.

The lawsuit was filed against Bondo Corp. of Atlanta by Michael DiPirro under Proposition 65, a ballot initiative passed by state voters in 1986.

Bondo makes an automobile touch-up paint containing the industrial solvent toluene, which has been listed by the state as a chemical known to cause birth defects.

Source: Bay City News Wire.

Jul 19 – Boron as a Medicinal Ingredient in Oral Natural Health Products (Canada)

July 19th, 2007

New allowable limits for the use of boron in oral natural health products:

Health Canada has set a maximum limit of 0.7 mg of elemental boron equivalents per daily dose for boron as a trace mineral as part of an “Adults only” multivitamin-multimineral natural health product.

In cases where boron is included as one medicinal ingredient in multiple ingredient natural health products for a specific therapeutic purpose, Health Canada has set a limit of no more than 3.36 mg of elemental boron equivalents per daily dose. Such boron-containing natural health products will be labelled “Adults only” and will be contraindicated for pregnant or breast-feeding women. A caution to consult with a health care practitioner prior to use in cases where an estrogen-dependent cancer exists, will also be on the label. In this situation, Health Canada is taking a precautionary approach, despite the fact that the maximum dose is at the range of the average daily intake of boron naturally occurring in food and water.

More information available here: Boron as a Medicinal Ingredient in Oral Natural Health Products.

Jul 18 – Updated NHPD Guidelines

July 18th, 2007

The July 2007 NHPD Monthly Communiqué includes the following of interest to many of our clients:

Product Licensing Information

Updated Guidelines – How to Reclassify a Product Licence Application into the Compendial or Non-compendial stream

The Natural Health Products Directorate (NHPD) has recently revised its guidelines and procedures for applicants wishing to reclassify a product licence application that has already been submitted for review. Note that these new guidelines replace those that were previously published in the October 2006 issue of the NHPD Monthly Communiqué.

Full information available in the NHPD Monthly Communiqué.

Jul 18 – EU court bans Syngenta weed killer

July 18th, 2007

The Business Journal on an EU ban of a popular weed killer:

A European Union court has banned a chemical used as a common weed killer, based on claims the substance does not meet health standards, according to a report by the Associated Press.

The chemical paraquat is the primary ingredient in one of the world’s most widely used herbicides, Syngenta AG’s Gramoxone product. Gramoxone is marketed in North America by the Swiss company’s regional crop protection headquarters operation in Greensboro.

The “Court of First Instance” agreed with complaints from Swedish environmental officials that paraquat had not been adequately investigated as a potential health hazard prior to a regulatory ruling allowing its use in the European Union in 2003.

Syngenta says its product is not harmful when used as directed, and claims it has been used safely in 120 countries for more than 40 years. It is approved for use in the United States, but only by certified applicators.

Jul 18 – State Set to Add Methanol to Prop. 65 Warning List

July 18th, 2007

An article from the Orange County Business Journal on the likely addition of Methanol to California’s Prop 65 list:

Companies in coatings, automotive and adhesives are bracing for yet another listing of a popular solvent as hazardous.

State regulators are close to listing solvent methanol as a hazardous chemical under the state’s Proposition 65 law, requiring employers that use methanol to notify workers and neighbors that they could face harmful health effects.

Methanol is a “wood alcohol” that’s used in antifreeze, cleansing solutions, varnishes, paints and adhesives. It’s commonly used as a chemical agent to help make other industrial chemicals, such as formaldehyde.

Last month, scientists with the Office of Environmental Health Hazard Assessment at the California Environmental Protection Agency released a report saying it is considering listing methanol as a hazardous chemical under Proposition 65.

Jul 18 – Nanoscale Program Approach for Comment (EPA)

July 18th, 2007

A recent bulletin from the EPA: Nanoscale Program Approach for Comment which includes the following information:

To ensure stakeholder involvement in the development of the Nanoscale Materials Stewardship Program, EPA has issued Federal Register (FR) notices seeking public comment on a concept paper and other materials connected to this program…

On October 18, 2006, EPA launched a collaborative process and invited stakeholders to participate in the design, development and implementation of a Nanoscale Materials Stewardship Program (NMSP) under TSCA. The release of the July 2007 NMSP concept paper, TSCA Inventory paper, and Information Collection Request for the NMSP for public review and comment are an important part of the collaborative development process. These draft documents are intended to further discussion about the NMSP and will serve as the foundation for establishing the details of the NMSP.

The full release is available here.

Jul 18 – Russia forced to apply costly EU chemical standards (REACH)

July 18th, 2007

Forbes discusses the cost of REACH compliance to Russian business in Russia ‘forced’ to apply costly EU chemical standards:

Russia will be ‘forced’ to apply EU safety standards in the chemical industry, which will cost Russian companies up to 10 percent of their export earnings, Russian officials said.

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a European Union regulation which greatly tightens standards for the chemical industry, came into force this year.

‘If one of our main strategic economic partners uniting 27 countries introduces such strict legislation, then Russia will be forced to apply these requirements,’ the Russian energy and industry ministry said in a statement.

Although an EU measure, companies from all over the globe will feel the costs of REACH compliance.