Category Archives Issue 456

The European Commission (EC) has concluded, in its second regulatory review on nanomaterials, that, while certain challenges continue to face those trying to assess their potential risks, the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) “sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures.” Still, the EC acknowledges that “more specific requirements for nanomaterials within the framework have proven necessary,” and thus it “envisages modification in some of the REACH Annexes and encourages ECHA [European Chemicals Agency] to further develop guidance for registrations after 2013.” REACH took effect in June 2007. Viewed as the strictest law regulating chemical substances to date, it requires all chemicals imported or produced in the European Union (EU) over a certain quantity to be registered and the manufacturers and importers to gather and report information about the chemicals’ properties. The law’s provisions will be…

The European Commission has published its list of flavoring substances authorized for use in foods. Effective October 22, 2012, Regulation EU 872/2012 provides a roster of more than 2,500 substances evaluated by the European Food Safety Authority (EFSA) and deemed safe for human food uses, while Regulation EU 873/2012 establishes transitional measures for other flavorings, such as those made from non-food sources, that are still under review. Flavoring substances not found on the list “will be banned after an 18-months phasing-out period.” To prepare the new regulations, EFSA’s Scientific Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (the CEF Panel) initially considered approximately 2,800 substances already on the EU market as well as 197 additions. Although the majority of substances reportedly did not present safety concerns, the CEF Panel recommended removing seven substances from commerce and asked for further data on 400 others. Industry can submit data on…

While foreign and domestic food facilities, including farms, must renew their registrations with the Food and Drug Administration (FDA) beginning October 1, 2012, under the Food Safety Modernization Act, the agency is not accepting registration renewals at this time. Facilities required to be registered under the law are asked to check FDA’s website to learn when the system becomes available,

The Federal Trade Commission (FTC) has revised its Green Guides to “help marketers avoid making misleading environmental claims.” According to FTC, the revisions reflect “hundreds of consumer and industry comments” and include changes to existing Guides “as well as new sections on the use of carbon offsets, ‘green’ certifications and seals, and renewable energy and renewable materials claims.” In particular, the updated guidance advises against “broad, unqualified claims that a product is ‘environmentally friendly’ or ‘eco-friendly’” because such claims are “nearly impossible to substantiate.” FTC has also warned marketers about the use of unqualified degradable claims for solid waste products and items destined for landfills, incinerators or recycling facilities, and clarified its guidelines for compostable, ozone, recyclable, recycled content, and source reduction claims. In addition, the Green Guides now offer new sections covering issues not anticipated in previous editions, such as (i) certifications and seals of approval, (ii) carbon offsets,…

The U.S. Federal Trade Commission (FTC) conducted a day-long workshop, October 2, 2012, “to examine competition and consumer protection issues in the pet medications industry.” Currently pending before the House Subcommittee on Health, a bill (H.R. 1406) introduced in April 2011 by Representative Jim Matheson (D-Utah) would require FTC to issue rules mandating pet medication prescription portability, which could fundamentally change the way such products are sold in the United States. FTC seeks stakeholder input on issues that would affect a $7 billion per year industry and has extended the public comment period to November 1. An early step in FTC’s investigation, the workshop provided a forum for widely divergent views as veterinary professional advocates and representatives of the animal health industry addressed current practices limiting the distribution of pet medications and the potential impact of a change that would allow consumers to purchase the drugs from a full range…

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