Nano and sustainable materials: testing, commercialization and regulatory roundup
Data on nanomaterials in cosmetics in the UK
The United Kingdom’s (UK) Office for Product Safety and Standards (OPSS) has invited interested parties, including academia, manufacturers, and consumer associations, to submit scientific information relevant to the safety assessment of metallic, silica-based and hydroxyapatite nanoparticles used in cosmetics. The deadline for data relevant to silica-based nanoparticle use is 27 June 2025. For the other materials, it is 22 December 2023.
Action on food additives in California
The California State Senate Appropriations Committee is on the verge of passing a bill which bans the use of red dye No. 3, brominated vegetable oil, propylparaben, and potassium bromate in food sold in the state. A Senate amendment on September 1 removed titanium dioxide from this list.
A re-think on bisphenol regulation in Germany
German regulators have temporarily withdrawn a proposal to restrict the use of five bisphenols, following comments to the six-month public consultation, the first time a dossier submitter has taken such action. The proposal differentiated between uses where the bisphenol molecules are present as ‘free monomer’ and those where they are chemically bound to a matrix (and less likely to migrate to the environment). The German Federal Institute for Occupational Safety and Health (BAuA) will be reconsidering this tiered approach based on feedback.
Partially hydrogenated oils are not GRAS
The US Food and Drug Administration (FDA) has issued a direct final ruling that the use of partially hydrogenated oils (PHOs) in food is no longer generally recognized as safe (GRAS). This completes administrative actions on their 2015 determination, which established January 1, 2021, as a compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.
US Government Agencies must buy sustainably
A Sustainable Products and Services procurement rule proposed by the US Biden-Harris Administration would expand sustainable purchasing requirements and direct US government agencies to follow EPA’s Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing, which address energy or water efficiency, PFAS reduction or elimination, bio-based content, recycled content, ozone-safe substances, and more. Comments on the proposed rule are due by October 2, 2023.
Free databases for exposure assessment data and regulatory information
The US Environmental Protection Agency (EPA) has published ChemExpo, a search and visualization tool for exploring chemical use data relevant to exposure assessment curated from public documents. The application provides access to data collected by the EPA about how chemicals are used in commerce and how they occur in consumer and industrial products.
CIRS Group, a product safety and regulatory consulting firm headquartered in Hangzhou, China, has released ChemRadar, which integrates existing Asia-Pacific Chemical Inventory Search System (APCISS) tools and provides regulatory information on hundreds of thousands of chemical substances related to import/export, hazard communication, and chemical registration.
Company News
Following its purchase of NanoSafe Inc. in April 2023, ITA International has been awarded a grant from the US National Institutes of Health (NIH) to refine evaluation protocols for nanomaterials use in advanced manufacturing products (such as 3D printers and laser engravers), cosmetics, filtration appliances, face masks and other high-risk products and more effectively communicate results to a broad consumer base.
Expanding from Serving Trays, Arcos Dorados, the world’s largest independent McDonald’s franchisee, is now using UBQ™ (a plastic substitute made from unrecyclable household waste) in bench seating and electrical casing components in their new São Paulo restaurant.
Performance Biofilaments Inc.. has started production in the world's largest nanofibrillated cellulose (NFC) commercial production plant in Quebec, Canada. With a capacity of 7,000 metric tons a year, the plant will provide low-carbon additives to enhance the performance of concrete and mortars, nonwovens, industrial fluids, biocomposite plastics, thin films and in mineral consolidation applications.
Conagen, USA, and Sumitomo Chemical, Japan, have announced joint development of 100% renewable p-hydroxystyrene (HS) and its polymer, poly p-hydroxystyrene (PHS), using a combination of biosynthesis, chemosynthesis and polymerization.
Amyris, Inc, one of the trailblazers in the production of sustainable ingredients for consumer products using biofermentation, has filed for bankruptcy in the US and will divest from its clean beauty consumer brands.
Notable reports and papers
Nano-specific alternative methods in human hazard/safety assessment under different EU regulations, considering the animal testing bans already in place for cosmetics and their ingredients: final version of a review from the European Union Observatory for Nanomaterials (EUON) that assesses animal-free alternative methods for safety testing of nanomaterials.
US federal perspective on critical research issues in nanoEHS: the current status of nanotechnology environmental, health, and safety (nanoEHS) research from the perspective of Federal Government Agency participants in the US National Nanotechnology Initiative (NNI) interagency Nanotechnology Environmental and Health Implications Working Group (NEHI).
Regulatory landscape of alternatives to animal testing in food safety evaluations with a focus on the western world: a review from authors at the Intertek Health Sciences Inc., Canada and Tate & Lyle of the current state and challenges of regulatory acceptance of new approach methodologies (NAMs) which focus on predicting toxicity based on mechanistic data rather than data from animal models.
Status, implications and challenges of European safe and sustainable by design paradigms applicable to nanomaterials and advanced materials: a report on safe and sustainable by design (SSbD) approaches highlighting recent work to meet the challenges to their practical implementation, including progress on projects that Vireo is carrying out as a DIAGONAL Project Partner.