2025 Chemical & Nanomaterial Regulatory Roundup
1. Food contact regulatory clearances of microfibrillated cellulose (MFC)
Vireo Advisors and the Alliance for Food Safety Acceptance of Fibrillated and Crystalline Celluloses achieved the following regulatory clearances:
5 successful Food Contact Notifications (FCNs) opened the United States market to the use of MFC in food contact paper, paperboard, plastics, and adhesives, as well as a coating on fruits and vegetables with non-edible peels.
Successful petitions to list MFC in German Federal Institute for Risk Assessment (BfR) Recommendations XXXVI, XXXVI/1, XXXVI/2, XXXVI/3 and XIV opened the European Union (EU) market to the use MFC in paper, paperboard, and moulded fiber food contact applications, as well as coatings on food contact materials.
2. Changes to Prop 65 labelling rules
Amendments to California Proposition 65 (Prop 65) took effect on January 1, 2025
Manufacturers have a 3-year grace period to ensure compliance with these new amendments (by January 1, 2028)
The updates include:
o Making the Proposition 65 short-form warning more informative;
o Clarifying the suitability of short-form safe harbor warnings for food;
o Clarifying safe harbor warning requirements for sufficient labelling in online retail;
o Adding new safe harbor warnings for certain classes of vehicles; and
o Adding signal words for food warnings.
3. The EU bans the use of certain nanomaterials in cosmetic products
Amendments to Annex II and Annex III of the EU Cosmetics Regulation (EC) No. 1223/2009 took effect on February 1, 2025.
The following nanomaterials are now restricted from use in cosmetics placed on the EU market:
o Copper (nano);
o Colloidal silver (nano);
o Gold (nano); and
o Platinum (nano).
4. France bans the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in products
The prohibition of PFAS under Law No. 2025-188 of 27 February 2025 took effect on January 1, 2026.
PFAS are now prohibited from products manufactured, imported, exported, and placed on the market.
The main products affected include certain clothing, cosmetics, textiles, and waxes.
5. China updates food contact standards and test methods
o GB 9685-2016 is China’s National Food Safety Standard.
o The amendment introduced 5 testing standards for quantifying levels of migrants or residuals.
o The standards will take effect in March or September 2026.
o Of the 4 standards that pertain to FCMs, 2 are migration testing standards.
o The main FCMs affected include 1) paints and coatings and 2) silicone rubber.
The default values were published to help chemical submitters develop submissions at lower risk of requiring reworking or resubmission.
The assumption guide may be periodically updated in response to new advancements in exposure modelling.
Standards Updates
1. Guidelines and standards
a. Guidance Document on Aspects of OECD TG 305 on Fish Bioaccumulation
b. OECD GD No. 417 for Toxicokinetics
i. A guidance document introducing a harmonized framework for generating and reporting research data to support regulatory decision-making
ii. Explicitly addresses nanomaterials and advanced materials
c. OECD SSbD guidances
i. OECD Safe and sustainable by design tools
ii. Practical guidance for innovators to select suitable SSbD tools
d. ISO/TS 9651:2025 Nanotechnologies — Classification framework for graphene‐related 2D materials
e. UK Nanosafety Group (UKNSG)’s 3rd edition of its Working Safely with Nanomaterials in Research and Development guidance
f. IUPAC’s Guiding Principles of Responsible Chemistry
Watchlist
a. Most CBI claims under TSCA will expire after 10 years.
b. CBI claims must be reasserted and substantiated to remain active.
c. 2026 marks the first year that CBI claims made under the amended TSCA framework are set to expire.
2. EPA aims to eliminate animal testing and authorize chemicals using New Approach Methods by 2035.
3. The US Congress is proposing changes to TSCA.