A notice from the NHPD:
The revised Evidence for Quality of Finished Natutal Health Products guidance document (June 2007 – Version 2.0) is available online at:
http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq_e.html.
From the OEHHA:
The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding anthraquinone (CAS No. 84-65-1) to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code section 25249.5 et seq., commonly known as Proposition 65). The listing of anthraquinone is effective September 28, 2007.
Anthraquinone (CAS No. 84-65-1) is being listed as a chemical known to the State of California to cause cancer. The listing of this chemical is based on formal identification by an authoritative body (i.e., the National Toxicology Program (NTP)), that the chemical causes cancer. The criteria used by OEHHA for the listing of chemicals under the “authoritative bodies” mechanism can be found in Title 22, Cal. Code of Regs., section 12306.
The reader is directed to the Notice of Intent to List Anthraquinone (CAS No. 84-65-1) published in the July 21, 2006 issue of the California Regulatory Notice Register (Register 2006, No. 29‑Z) for the documentation supporting OEHHA’s determination that the criteria for administrative listing have been satisfied for this chemical.
OEHHA analysis of dose-response data to establish the no significant risk level (NSRL) for anthraquinone (CAS No. 84-65-1) under Proposition 65 has not yet been conducted. The priority status for the development of such analysis will be announced in a future OEHHA Proposition 65 Status Report for Safe Harbor Levels, available at http://www.oehha.ca.gov/prop65.html.
Chemical: Anthraquinone
CAS No.:84-65-1
Toxicological Endpoint: cancer
Listing Mechanism(1): AB
(1) Listing mechanism: AB – “authoritative bodies” mechanism (Title 22, Cal. Code of Regs. section 12306)
This information on the FDA in from OMBWatch.com:
Congress has passed legislation which will reauthorize a program allowing the U.S. Food and Drug Administration (FDA) to collect fees from pharmaceutical companies in order to conduct drug approvals. The bill will also dramatically expand FDA’s regulatory authority in response to recent controversy. President George W. Bush is expected to sign the bill into law soon.
In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA gives the FDA the authority to collect fees from pharmaceutical companies for the safety review and approval of new drugs. Under the original legislation, Congress must reauthorize PDUFA every five years. PDUFA is set to expire Sept. 30.
The Food and Drug Administration Amendments Act of 2007 (H.R. 3850) will renew and expand the user fee program. FDA will increase the amount of user fees it collects to almost $400 million, up from approximately $300 million. User fees will fund approximately half of the agency’s drug review program and a fifth of the agency’s overall budget.
See the full article here: Congress Expands FDA User Fee Program, Reforms Drug Safety Process .
This section of the EUobserver.com’s article Commission wants ‘extremely high’ toy safety standards caught our eye:
The European Commission on Tuesday (25 September) said it is taking the problem of potentially harmful toys seriously and is overhauling legislation in the area, following a series of recalls of toys made in China on safety grounds…
“[Toys] are a product aimed at the most vulnerable group of consumers and therefore (…) we should set standards extremely high,” he said. For instance, there would be a new rule concerning chemical substances, and mandatory testing and certification of certain types of toys.
We will be adding more articles on this topic as they come in.
From eNewsUSA:
The Government Accountability Office (GAO) released a letter report entitled, Chemical Regulation: Comparison of U.S. and Recently Enacted European Union Approaches to Protect against the Risks of Toxic Chemicals (GAO-07-825, August 17, 2007). The report was requested by Senator Barbara Boxer (D-CA), Chair, Committee on Environment and Public Works AND Senator Frank Lautenberg (D-NJ)…
GAO indicates that REACH requires companies to develop information on chemicals’ effects on human health and the environment, while TSCA does not require companies to develop such information absent EPA rule-making requiring them to do so. While TSCA does not require companies to develop information on chemicals before they enter commerce (new chemicals), companies are required to provide EPA any information that may already exist on a chemical’s impact on human health or the environment…
See the full article here.
From Marketwatch.com:
Congress has approved a bill giving the Food and Drug Administration more authority to police prescription drugs, with a unanimous vote from the Senate Thursday following strong House approval earlier in the week.
The measure would require the FDA to monitor drugs after they’ve been approved for the market. It also grants the agency authority to order new studies, restrict distribution and require label changes for medications already on the market.
See the full article here: Congress OKs bill giving new power to FDA
Very interesting article from Advertising Age. Here’s a snippet:
Their concern is that phthalates, a chemical found in some air fresheners, have been shown in some lab-animal studies to disrupt testosterone production and cause malformation of sex organs. Some studies of humans have linked exposure to the chemicals with adverse changes in the genitals of baby boys. The groups’ petition also said volatile organic compounds such as benzene, linked to cancer, can be found in some of the air fresheners, though it did not specify levels of that chemical in individual products.
While marketers challenged the validity of research by the NRDC, which tested 14 products for sale at Walgreens for phthalates, the drugstore chain has pulled three of its own private-label air fresheners off shelves of its 5,850 stores nationwide and initiated testing of other brands. The Walgreens brands had the highest levels of phthalates among the products tested.
“Even prior to the release of the report, the manufacturer of one of the private-label products already had been in the process of reformulating it,” a Walgreens spokeswoman said. “So in some sense, they were already aware of the concern, but we were not aware of the concern.”
For the full article see: Fear of Phthalates Spreads to $1B Air-Freshener Category
Euractiv.com recently updated their page of Food Safety in the EU information. Quite useful for any companies preparing food labels for the European market.
Electronics Supply and Manufacturing on REACH:
Make sure that your supply network understands REACH and its need to pre-register otherwise your company may face a potential supply disruption.
The new European Union-wide law entitled “Registration, Evaluation, and Authorization of Chemicals”, or REACH, went into effect on June 1, 2007. The title would make one think that it’s a chemical-related law, so why do manufacturers of electronic products, termed “articles” in REACH-speak, need to worry about a chemical substance regulation?
Here’s why: electronic products are manufactured with and from literally thousands of chemical substances. Most substances will be subject to registration under the REACH legislation, and certain substances of very high concern will be subject to authorization, which could eventually result in their restriction.
While RoHS made us think about only six hazardous substance groups , which ultimately equates to about 100 substances when materials such as oxides and the various congeners of the flame retardants are considered, there are still many toxic and otherwise hazardous substances used in electronic and electromechanical products as well as in their manufacture today.
The full article available here.
Nexreg has more information on REACH at the following links:
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
Nexreg Canada: (519)488-5126 (London, ON)
Nexreg UK: +44 020 7993 5893 (London, UK)
Nexreg USA: (206)418-6663 (Seattle, WA)
E-mail:info@nexreg.com
The U.S. Environmental Protection Agency has released the first set of Hazard Characterizations on 101 High Production Volume (HPV) chemicals. These characterizations are based on EPA’s scientific review of the screening-level hazard, or toxicity, data that was submitted by the U.S. chemical industry through EPA’s HPV Challenge Program or other information previously collected by the agency.
The HPV Challenge Program challenged companies to provide the public with basic health and safety data on chemicals that are manufactured in excess of a million pounds a year. The hazard characterizations include a summary of the data submitted, EPA’s evaluation of the quality and completeness of the data, and an assessment of the potential hazards that a chemical or chemical category may pose. EPA will combine this information with human and environmental exposure information collected from EPA’s Inventory Update Reporting to develop a risk characterization and, based on that review, determine if additional action is needed to ensure the safety of the HPV chemicals’ manufacture and use.
The agency intends to use this approach to assess risks and identify and take needed action on 3000 HPV chemicals by 2012. This was one of the elements of the North American chemical cooperation commitment announced by the U.S., Canada and Mexico at the Security and Prosperity Partnership North American Leaders’ Summit in Canada in August.
EPA will continue to prepare and periodically post additional HPV chemical hazard characterizations as they are developed. The agency also intends to post risk characterizations on chemicals when they are developed and completed, beginning later this year.
Review the first set of hazard characterizations: http://iaspub.epa.gov/oppthpv/hpv_hc_characterization.get_report