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California Regulatory Actions

US Regulatory Actions

EPA Conditionally Registers Nanosilver As a New Active Ingredient

EPA final rule on significant new use rule for multi-walled carbon nanotubes

EPA Promulgates SNUR for Infused Carbon Nanostructures

On April 4, 2012, the U.S. Environmental Protection Agency (EPA) promulgated, through a direct final rule, significant new use rules (SNUR) for 17 chemical substances that were the subject of premanufacture notices (PMN). This includes a SNUR for “infused carbon nanostructures (generic).” According to EPA, the PMN states that the generic (non-confidential) use of the substance is as an additive to provide conductive properties to reinforcements used in composites.

EPA Scheduled to Publish Proposed SNURs for 17 Chemicals, Including CNTs

California Reports

Recommendations For Addressing Potential Health Risks From Nanomaterials In California

Nano Food Issues

European Food Safety Authority Guidelines to assess potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.

Guidance is provided on: (i) the physico-chemical characterisation requirements of engineered nanomaterials used e.g. as food additives, enzymes, flavourings, food contact materials, novel foods, feed additives and pesticides and; (ii) testing approaches to identify and characterise hazards arising from the nanoproperties which, in general, should include information from in vitro genotoxicity, absorption, distribution, metabolism and excretion and repeated-dose 90-day oral toxicity studies in rodents. The guidance allows for reduced information to be provided when no exposure to the engineered nanomaterial is verified by data indicating no migration from food contact materials or when complete degradation/dissolution is demonstrated with no absorption of engineered nanomaterials as such. The guidance indicates uncertainties that should be considered to perform a risk assessment. As this sector is under fast development, this guidance document will be revised as appropriate.

FDA Issues Guidance on Nanotechnology

U.S. Food and Drug Administration - Guidance For Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients that are Color Additives

On April 20, 2012, the U.S. Food and Drug Administration (FDA) issued the draft guidance document "Guidance For Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients that are Color Additives." FDA will take comment on the guidance document for 90 days within publication in the Federal Register. The primary point in this guidance document is to determine when use of nanotechnology in manufacturing food ingredients, food contact substances (FCS), including packaging and pigments, may affect the safety of the end product. FDA takes great care to outline the regulatory pathways for various components of food and the steps necessary to demonstrate their safety. FDA points out that alteration in particle size distribution on the nanometer scale, which alter the physical and/or chemical properties of food ingredients and FCSs, can sometimes be significant manufacturing changes requiring new testing or regulatory filings. The guidance is clear, though, that FDA's primary concern is with the intentional alteration of particle size on the nanometer scale of food substances already used in food. FDA also reiterates its position that use of nanotechnology in FDA-regulated products is not in itself inherently harmful or benign. Rather, FDA considers the characteristics of the product and the safety of its intended use -- whether derived from conventional manufacturing or from nanotechnology.

Nano Medicine Issues

European Commission Requests Scientific Opinion On Health Effects Of Nanomaterials Used In Medical Devices

On March 27, 2012, the European Commission (EC) posted a request to the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) for a scientific opinion on the health effects of nanomaterials used in medical devices. According to the EC's request, in the field of medical devices, the following cases of alleged use of nanomaterials have been identified by Notified Bodies:

Carbon nanotubes in bone cements;

Nanopaste hydroyapatite powder for bone void filling;

Polymer setting material with nanoparticles in dental cements;

Polycrystalline nanoceramics in dental restorative materials;

Nanosilver or other nanomaterials used as coatings on implants and catheters; and

Nanosilver used as an antibacterial agent, for example in wound dressings.