Health Canada has recently issued a discussion paper. The paper, feedback form and questions are available on the following webpage: Managing Health Claims for Foods in Canada:Towards a Modernized Framework. Note:
Please note that the deadline for submission of comments is extended to March 31, 2008.
More information can be found at the above link.
This goes beyond the regular scope of Regulatory Compliance News by Nexreg Compliance, but we thought our readers would be interested. From EurActiv.com:
The chemicals industry could soon have access to a quicker and cheaper means of testing the toxicity of chemicals as the US Institutes of Health (NIH) and the Environmental Protection Agency (EPA) have joined forces to use advances in computers, genomics and cellular biology to develop a new high-speed in-vitro testing method for this purpose.
The new method would “allow for the testing of thousands to hundreds of thousands of chemicals a day to determine their possible toxic effect,”…
The EU’s chemicals regulation REACH, in force since June 2007, requires producers and importers of chemicals to register all such substances within the European chemicals agency and to prove that they are safe. Based on the safety data, the EU agency will then either authorise or reject the applications for market authorisation. The regulation was strongly objected to by the chemicals industry, which argued that the economic burden of the imposed safety testing was unacceptable.
For more information click on the above link.
From the Canada Gazette –
Regulations Amending the Transportation of Dangerous Goods Regulations:
Whereas, pursuant to subsection 30(1) of the Transportation of Dangerous Goods Act, 1992 (see footnote a), a copy of the proposed Regulations Amending the Transportation of Dangerous Goods Regulations, substantially in the form set out in the annexed Regulations, was published in the Canada Gazette, Part I, on September 30, 2006 and a reasonable opportunity was thereby afforded to interested persons to make representations to the Minister of Transport, Infrastructure and Communities with respect to the proposed Regulations;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Transport, Infrastructure and Communities, pursuant to section 27 of the Transportation of Dangerous Goods Act, 1992 (see footnote b), hereby makes the annexed Regulations Amending the Transportation of Dangerous Goods Regulations.
The full amendment is at the above link. There are a significant number of changes; we highly recommended anyone affected by the TDG regulations to closely study the amendment.
GHS Revision 2 is finally available online (previous it was available only in book form). The files are available at the UN website:
http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/02files_e.html.
Nexreg has more information on GHS at the following links:
To speak to a Nexreg representative about how GHS or 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
A recent release from the ACGIH:
ACGIH announced today that its Board of Directors ratified the 2008 Threshold Limit Values (TLVs) for Chemical Substances and Physical Agents and Biological Exposure Indices (BEIs). The Board also approved recommendations for additions to the Notice of Intended Changes (NIC).
A listing of the substances that were acted upon is attached. The Annual Reports of the ratifications of the ACGIH® Board will be published in the winter issue of the ACGIH newsletter, Today! Online, and can be found online at http://www.acgih.org/Store/ProductDetail.cfm?id=2001. ACGIH members can download the electronic version of the Annual Reports at no cost. Nonmembers may also acquire the report through the ACGIH® website for $19.95.
Draft Documentation for the substances on the Notice of Intended Changes (NIC) are currently available for purchase at www.acgih.org/store. Documentation for the adopted substances and agents will be available March 14, 2008. All Documentation are in PDF format and priced at $60 each. ACGIH members are entitled to five free Documentation downloads per year.
For more information, click on the above link.
A recent release from the OEHHA:
…Many interested parties have requested that OEHHA provide more guidance concerning acceptable methods for providing warnings to consumers for exposures to listed chemicals in foods purchased at retail stores. The specific guidance currently provided by regulations concerning the range of possible options for providing Proposition 65 warnings for exposures from foods in the retail context are very limited. In addition, guidance may be needed concerning the content of any required warning (i.e. what additional information may be provided and in what format that would still be considered “clear and reasonable” under the Act).
As an initial step toward the development of a regulatory proposal on this subject, OEHHA is requesting input from stakeholders in the enforcement and business communities, as well as other members of the public concerning the range of options that could be included in any amendment to the safe harbor warning regulations that would specifically apply to exposures to listed chemicals in food products. Examples of such input would be ideas about on-product labels, off-product signage, centralized warnings for all affected food products in the store, in-store warning information kiosks, print media warnings or web-based information. OEHHA is also requesting stakeholder input concerning the content of warnings for exposures to listed chemicals in foods, specifically language that conveys the required warning message, without undue confusion for consumers.
For more information, click on the above link.
A story that has appeared in a few newspapers:
The Food and Drug Administration regulates everything from lipstick and nail polish to lotions and sunscreens, but it long has ignored a possible hazard that can really get under your skin — the inks and pigments used in tattoos.
Prompted by reports of skin problems, including rashes, swelling and blistering, the FDA has started taking a hard look at materials tattoo artists have injected into the skin of some 45 million Americans.
For the first time, FDA scientists have launched studies to identify the chemical composition of tattoo and permanent makeup inks, how they break down in the body, the long-term safety effects and the products that may pose the greatest risk.
If the government ultimately decides to impose restrictions, the move could shake up an industry that attracts little regulatory oversight and bring what some say is needed protection to consumers.
Click on the above link for the full article.
At least one lobby group is trying to make it happen, according to CosmeticsDesign.com:
A Canadian lobby group has called on Health Canada to make labeling phthalates a requirement on personal care products in response to a study linking baby care products to the chemical’s concentration in infant urine.
The British Columbia-based Labour Environmental Alliance Society (LEAS) states that phthalates should be included on the ingredients list of personal care products so that consumers can make an informed choice…
Under current US and Canadian law manufacturers are not required to label the presence of phthalates in their products.
Furthermore, certain compounds that have been banned from appearing in consumer products by the European Union are not prohibited in North America.
The LEAS are calling for the labeling of the compounds to be mandatory and for Canada to follow Europe’s lead in regulating the use of phthalates in consumer products.
Click on the above link for the full article.
A small piece published on the New York Times website. Useful for beginners in the US:
The U.S. Occupational Safety and Health Administration (OSHA) requires that business owners maintain a Material Safety Data Sheet (MSDS) for every potentially hazardous material their employees come in contact with during the course of their daily business activities. These documents provide information such as melting and boiling points for hazardous materials, toxicity levels, possible health effects of exposure, first aid procedures, storage and disposal advice, and spill and leak procedures.
An MSDS protects both you and your employees and also keeps you in compliance with government regulations. You can be penalized for noncompliance.
From this month’s NHPD Monthly Communiqué – 3 new monographs and 20 revised monographs. As well, a clarification to Natural Health Product advertising claims:
The purpose of this article is to clarify the review of advertising claims in proposed label texts by the Natural Health Products Directorate (NHPD).
The NHPD reviews proposed label texts as per the labelling requirements set out in Part 5 of the Natural Health Products Regulations. Part 5 does not outline any requirements with respect to advertising claims and as such, the NHPD will no longer review advertising claims indicated on the label texts. Applicants are responsible for ensuring that advertising claims on the labels of their products do not contravene Section 9 of the Food and Drugs Act.
Section 9(1) of the Food and Drugs Act states that “No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
Advertising claims will not be reviewed during assessment with the exception of comparative claims and “clinically proven/tested” claims. The NHPD may request additional evidence to support comparative and “clinically proven/tested” claims. Furthermore, compendial applications with comparative claims that require additional evidence may see their applications transferred to the non-traditional assessment stream. If the claim is removed, the application can remain in the compendial assessment stream.
For more information, click on the above link.