Food:
PPWR Key Requirements application from August 12, 2026
The EU Packaging and Packaging Waste Regulation (PPWR), Reg. (EU) 2025/40, has introduced new requirements to reduce packaging waste, improve recyclability and reuse, and support the transition towards a circular economy.
From August 12, 2026, key requirements include:
- Restrictions on lead, cadmium, mercury and hexavalent chromium in packaging.
- Minimization of substances of concern (SoCs) in packaging materials and components.
- New obligations for manufacturers and importers, including packaging identification, traceability, conformity assessment and technical documentation.
- Restrictions on PFAS in food-contact packaging, subject to specified concentration limits.
Further requirements will be progressively introduced:
– 2029: 90% separate collection target for plastic beverage bottles and metal beverage cans.
– 2030: Design-for-recycling requirements, recycled-content targets for plastic packaging and initial reuse targets.
– 2035: Packaging needs to prove recyclability on a mass scale.
– 2040: Higher recycled-content and reuse targets will come into force.
The PPWR will therefore progressively reshape how packaging is designed, manufactured, labelled, collected, reused and recycled across the EU.
For businesses placing packaging on the EU market, assessing materials, supply chains and compliance requirements will be essential to prepare for the upcoming deadlines.
Source: https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste_en
FDA Proposes Mandatory GRAS Notifications for Food Substances
The U.S. Food and Drug Administration (FDA) has proposed a major revision of the Generally Recognized as Safe (GRAS) framework.
The proposal was published on August 11, 2026, in the Federal Register. Comments are due by December 9, 2026.
The key changes that have substantial implications for the food industry include:
- The exiting voluntary GRAS notification program would become mandatory.
- Companies introducing substances under the GRAS provision would generally need to notify FDA and provide the scientific basis supporting their GRAS conclusion.
- The requirement would apply on substances already used in food as well as those introduced for food use for the first time, subject to specified exceptions.
- A time-limited streamlined submission pathway is proposed for certain substances already in interstate commerce.
- The framework would cover both direct food ingredients and indirect uses, including food contact substances.
This could significantly increase FDA oversight and transparency around GRAS conclusions, if finalized. It would require companies to ensure that safety determinations are scientifically supported and appropriately documented.
The proposal represents a substantial change for companies relying on independent or voluntary GRAS notice to market food substances in the United States.
Medical Devices:
ISO 10993-3:2026
Published on August 6, 2026, the updated ISO 10993-3 replaces the 2014 edition for the biological evaluation of medical devices.
The updated standard focuses on:
- Long-Term Safety, by introducing revised requirements for evaluating genotoxicity, carcinogenicity, reproductive, and developmental toxicity.
- Risk-Based Approach, as the standard emphasizes integration with chemical characterization and toxicological risk assessment to minimize unnecessary testing.
- Manufacturer Action, as companies must update their Biological Evaluation Plans (BEP) for long-term and implantable devices to ensure compliance.
Source: https://www.iso.org/standard/10993-3
CLP:
European Commission Proposes CLP Update to Align with Latest GHS Rules
The European Commission is proposing a comprehensive revision of the CLP Regulation, with the objective of aligning EU classification and labelling rules with amendments made to the United Nations GHS.
The proposed changes include:
- New classification and hazard communication requirements for chemicals under pressure.
- Revised precautionary statements to improve clarity and usability.
- Greater use of non-animal testing methods for health hazard classification.
- New provisions for in-vitro and ex-vivo data when assessing skin corrosion and irritation.
- Updated classification approaches for metals and metal compounds regarding long-term aquatic hazards.
There are four major points in the adoption process:
- Stakeholders can submit comments until October 16, 2026.
- Planned adoption for Q4 2026.
- Most new requirements would apply 24 months after entry into force.
- Substances and mixtures already placed on the market under existing rules would benefit from a 48-month transition period.
The proposal is yet another significant step towards the development of hazard classification for EU chemicals, which may have implications on classification, labeling, SDS and regulatory compliance strategies.
Source: https://single-market-economy.ec.europa.eu/sectors/chemicals/chemicals-legislation_en
