An important notice (their words) from the NHPD:

The Natural Health Products Directorate (NHPD) has adopted a new approach to the review of compendial Product Licence Applications (PLAs). Effective June 24, 2008, Information Request Notices (IRNs) will no longer be issued for deficient compendial PLAs. The information provided in the PLA and proposed label text must correspond in full to that which is outlined in the monograph or the PLA will be refused. Applications corresponding in full to the monograph will proceed directly to licensing.

This new compendial review approach will apply only to compendial PLAs received after the effective date of June 24, 2008. Compendial PLAs received prior to June 24, 2008 will continue to be reviewed as per the previous review approach and IRNs will be issued if deficiencies are identified.

The adoption of this new approach will not impact the NHPD’s ability to process Compendial PLAs within the 60-day timeframe mandated by Section 6 of the Natural Health Products Regulations. Rather, it will enable the NHPD to maintain (if not increase) its high performance standard for Compendial PLAs. Furthermore, looking ahead to the future, this new method will help accustom applicants with the way Compendial PLAs will be reviewed and licensed once the NHPD’s Online Solution is implemented.

Click on the above link for more details.

Four more releases from the OEHHA. The first two are notices of intent to list chemicals. First, Avermectin:

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA), within the California Environmental Protection Agency, intends to list avermectin B1 (CAS No. 71751-41-2), as identified in the table below, as known to the State to cause reproductive toxicity, pursuant to the administrative mechanism. This chemical has been determined by OEHHA to meet the criteria set forth in Section 12306 for such listing under the authoritative bodies mechanism.

Second: Molinate:

As the lead agency for the implementation of Proposition 65, the Office of Environmental Health Hazard Assessment (OEHHA), within the California Environmental Protection Agency, intends to list molinate (CAS No. 2212-67-1), as identified in the table below, as known to the State to cause reproductive toxicity, pursuant to the administrative mechanism. This chemical has been determined by OEHHA to meet the criteria set forth in Section 12306 for such listing under the authoritative bodies mechanism.

Next, two requests for relevant information. The first of those two is for Imazalil:

Imazalil (CAS No. 35554-44-0) has previously been the subject of a request for relevant information pertaining to consideration for listing as known to cause reproductive toxicity under Proposition 65 (California Regulatory Notice Register 98, No. 52-Z). This chemical was under consideration for listing based on possible formal identification as causing reproductive toxicity by the U.S. EPA. OEHHA did not proceed with listing this chemical on the basis of the documents identified in the prior notices. More recent documents identified below appear to provide the basis for listing imazalil as causing cancer and as causing reproductive toxicity under Proposition 65.

The second of the two is for Thiabendazole:

Thiabendazole (CAS No. 148-79-8 . CAS No. for Thiabendazole hypophosphite salt is 28558-32-9) has previously been the subject of a request for relevant information pertaining to consideration for listing as known to cause reproductive toxicity under Proposition 65 (California Regulatory Notice Register; October 9, 1998, Register 98, No. 41-Z). This chemical was under consideration for listing based on possible formal identification as causing reproductive toxicity by the U.S. EPA. OEHHA did not proceed with listing this chemical on the basis of the documents identified in the prior notices. More recent documents identified below appear to provide the basis for listing thiabendazole and thiabendazole hypophosphite salt under Proposition 65.

For more information, click on the links.

Four newly added chemicals to California’s Prop 65 list. From the release:

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding benthiavalicarb-isopropyl (CAS No. 177406-68-7), mepanipyrim (CAS No. 110235-47-7), pirimicarb (CAS No. 23103-98-2) and resmethrin (CAS No. 10453-86-8) 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 date of the four chemicals is effective July 1, 2008.

Benthiavalicarb-isopropyl (CAS No. 177406-68-7), mepanipyrim (CAS No. 110235-47-7), pirimicarb (CAS No. 23103-98-2) and resmethrin (CAS No. 10453-86-8) are being listed as chemicals known to the State of California to cause cancer. The listing of the four chemicals is based on formal identification by an authoritative body (i.e., the U.S. Environmental Protection Agency (U.S. EPA)), that the chemicals cause 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.

Click on the above link for the full article.

A notice from the OEHHA:

Notice to Interested Parties – Request for Relevant Information on Chemicals to be Considered by the OEHHA Science Advisory Board’s Developmental and Reproductive Toxicant (DART) Identification Committee: Bromodichloromethane, Caffeine, and Methylisocyanate…

The Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board serves as the State’s qualified experts for rendering an opinion as to whether a chemical has been clearly shown through scientifically valid testing according to generally accepted principles to cause reproductive toxicity…

On January 18, 2008, OEHHA announced in a public notice published in the California Regulatory Notice Register (Register 08, No. 3) the selection of eight chemicals for the Committee’s review for possible listing under Proposition 65 and initiated the development of hazard identification materials for five of the eight chemicals (bisphenol A, chlorpyrifos, chromium (hexavalent), DDE, and sulfur dioxide).

By today’s notice, OEHHA is providing the public an opportunity to provide information relevant to the assessment of the evidence of developmental and reproductive toxicity for the three remaining chemicals: bromodichloromethane, caffeine, and methylisocyanate…

The publication of this notice marks the start of a 60-day data call-in period. This period will end on Tuesday, August 26, 2008.

Click on the above link for the full release.

From Food Navigator Europe:

The 31st session of the Codex Alimentarius Commission in Geneva this week will discuss over 30 texts concerning international food standards for subjects including the use of flavourings and product labelling…

The draft guidelines, amendments and codes of practices on the agenda for this year’s five-day meeting cover a wide range of categories, such as mycotoxin contamination, the use of flavourings, quantitative ingredient declarations and gluten-free foods…

The Codex group will also look at labelling issues this week. It will discuss the draft amendment to the guidelines for the Production, Labelling and Marketing of Organically Produced Foods; the amendment to the guidelines for use of nutrition and health claims; and the standard for quantified labelling of prepackaged foods…

Regarding gluten-free foods, the Codex commission will aim to determine an acceptable level and method for detection of gluten to allow better protection for people who are allergic to gluten.

Click on the above link for the full story.

This order makes a number of significant changes to the DSL, including:

• Part I amended by deleting 145 CAS No.s from Part I of the DSL
• An edit to Part II of the list

To get the full details about the changes, click on the above link.

A very important release from the Canada Gazette:

Canada’s Phosphorus Concentration Regulations (the Regulations) came into effect in 1989, and include a concentration limit of 2.2% for laundry detergents. The proposed Regulations Amending the Phosphorus Concentration Regulations (the proposed amendments) would broaden the scope of the Regulations to include other detergents and cleaners, and to lower the limits on permissible phosphorus concentrations. Specifically, the proposed amendments would

• lower the phosphorus concentration limit for household laundry detergents from the current limit of 2.2% to 0.5%;
• clarify that a phosphorus concentration limit of 2.2% would still apply to commercial and industrial laundry detergents;
• introduce a phosphorus concentration limit for household dish-washing compounds of 0.5% (including hand dish-washing soap and detergent for automatic dish-washers); and
• introduce a phosphorus concentration limit for household cleaners of 0.5%.

The proposed amendments would come into force on July 1, 2010.

Click on the above link for the full proposed regulatory text.

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.

A release from the EPA:

EPA is launching a broad effort to gain a greater scientific understanding of the potential health risks of formaldehyde’s use in pressed wood products. Through this process, EPA will develop risk assessments on potential adverse health effects, evaluate the costs and benefits of possible control technologies and approaches, and determine whether EPA action is needed to address any identified risks. The Agency plans to issue an Advance Notice of Proposed Rulemaking (ANPR) in fall 2008.

The Agency is pursing this course of action following review of a TSCA Section 21 citizens’ petition… which requested that EPA adopt nationally a recently enacted California regulation to control formaldehyde emissions from composite wood products and to extend the rule to include composite wood products in manufactured homes.

Click on the above link for the full release.

A notice of availability from the EPA – Protection of Stratospheric Ozone: Listing of Substitutes for Ozone-Depleting Substances–n-Propyl Bromide in Adhesives, Coatings, and Aerosols:

SUMMARY: The Environmental Protection Agency (EPA) is making available to the public information related to a May 30, 2007 proposed rule under the Significant New Alternatives Policy (SNAP) program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone-depleting substances and finds acceptable the use of alternatives that reduce the overall risk to public health and the environment. EPA proposed to list n-propyl bromide (nPB) as unacceptable for use as a substitute for chlorofluorocarbon (CFC)-113, methyl chloroform, and hydrochlorofluorocarbon (HCFC)-141b in the adhesive and aerosol solvent end uses; and acceptable subject to use conditions (limited to coatings at facilities that, as of May 30, 2007, had provided EPA with information demonstrating their ability to maintain acceptable workplace exposures) as a substitute for methyl chloroform, CFC-113, and HCFC-141b in the coatings end use. The Agency has received additional information regarding the exposure levels of n-propyl bromide found in the workplace due to use of aerosols containing n-propyl bromide, as well as information on industry practices from aerosol suppliers and from a survey of a significant number of end users. The Agency is requesting comment on these materials. We plan to consider this information, and any comments received during the comment
period on this notice of data availability, in determining what future action to take on our May 2007 proposal regarding the use of n-propyl bromide in aerosols.

DATES: Comments must be received on or before August 22, 2008.

For more information, click on the above link.