On February 3, 2026, the European Commission published Commission Regulation (EU) No. 2026/245, amending Regulation (EU) No. 10/2011 on plastic materials and articles intended to come into contact with food. This amendment introduces six new substances to the positive list of authorized substances and updates existing entries and verification requirements.
This amendment is part of the EU's ongoing efforts to update regulations on plastic food-contact materials, aiming to ensure they align with the latest scientific assessments and technological advancements while safeguarding food safety and consumer health.
| FCM Number | Substance Name | CAS Number | Key Limitations |
| 1084 | Triphenyl phosphite polymer with 1,4-cyclohexanediol and polypropylene glycol, C10–C16 alkyl ester | 1821217-71-3 | Additive in polyolefins (≤0.15% w/w); Specific migration limit (SML) for phosphate/phosphite is 5 mg/kg; Not suitable for infant formula/breast milk |
| 1089 | Calcium tert-butylphosphonate | 81607-35-4 | Nucleating agent in polyolefins (≤0.15% w/w); Upper limit of operating temperature 130°C; Not suitable for infant formula/breast milk |
| 1092 | Di-C14–C20 alkylamine oxide, derived from hydrogenated vegetable oil | 1801863-42-2 | Additive (≤0.1% w/w); suitable for non-fat foods only; not suitable for infant formula/breast milk. |
| 1093 | Oxidized Rice Bran Wax | 1883583-80-9 | Additive in PET, PLA, and rigid PVC (≤0.3% w/w); suitable only for non-fatty foods. |
| 1094 | 2,2'-Oxodiethylamine | 2752-17-2 | Comonomer (≤14% w/w); SML 0.05 mg/kg; Oligomer migration limit; Not applicable to infant formula/breast milk |
| 1096 | Oxidized Rice Bran Wax Calcium Salt | 1850357-57-1 | Additive in PET, PLA, and rigid PVC (≤0.3% w/w); suitable only for non-fatty foods. |
Material Functions and Applications
FCM 1084 (Triphenyl Phosphite Polymer): Primarily used as an antioxidant and stabilizer for polyolefins (such as polyethylene and polypropylene), preventing degradation due to thermal oxidation during processing and use. Suitable for food packaging films, containers, etc.
FCM 1089 (Calcium Tert-Butylphosphonate): As a nucleating agent for polyolefins, it improves the crystallization behavior of materials, increasing transparency, rigidity, and heat distortion temperature. Commonly used in food packaging requiring high transparency.
FCM 1092 (Dialkylamine Oxide): Used as an antistatic agent and lubricant, reducing static electricity buildup on plastic surfaces and improving processing performance. Limited to non-fatty food contact materials.
FCM 1093 & 1096 (Oxygenated Rice Bran Wax and its Calcium Salt): Naturally derived additives, used as lubricants and release agents, improving the processing flowability of plastics. Suitable for PET beverage bottles, PLA biodegradable packaging, rigid PVC sheets, etc.
FCM 1094 (2,2'-oxodiethylamine): As a comonomer for polyamides or polyesters, it can adjust the flexibility and chemical resistance of materials. Its migration limit is extremely low (0.05 mg/kg), reflecting its high safety requirements.
Revisions to Existing Entries
In addition to adding new substances, the regulations also revised existing positive list entries, particularly FCM number 768 (di-C14–C20 alkylamine oxide, derived from hydrogenated tallow; CAS number 143925-92-2). The revisions include a name change and updated usage restrictions, now limiting its use to non-fatty foods only under specific conditions.
New Validation Requirements
The regulations also introduced a new validation requirement: for compliance validation of 2,2'-oxodiethylamine (FCM 1094), water must be used as the test medium, rather than a standard food simulant. This requirement aims to more accurately simulate the migration behavior of this substance under real-world usage conditions.
Safety Assessment by the European Food Safety Authority (EFSA)
The six newly added substances have all undergone rigorous safety assessments by the European Food Safety Authority (EFSA). EFSA's assessments are based on comprehensive toxicological data, migration studies, and exposure assessments to ensure that these substances do not pose a risk to consumer health under specified use conditions.
Key assessment points include:
Toxicological characteristics: Assessing the substance's acute toxicity, repeated-dose toxicity, genotoxicity, and carcinogenicity.
Migration behavior: Investigating the potential for the substance to migrate from plastic materials to food or food simulants and determining safe migration limits (SMLs).
Exposure assessment: Estimating the potential exposure of consumers through dietary intake based on worst-case use scenarios to ensure it remains within safe thresholds.
Impurities and degradation products: Assessing the safety of impurities that may arise during manufacturing and the degradation products of the material under use conditions.
Impact and Significance on the Industry
1. Providing Legal Certainty for Material Innovation
This update opens up new formulation possibilities for the plastic food contact materials industry. In particular, the authorization of naturally derived additives (such as oxidized rice bran wax) reflects the EU's support for sustainable, bio-based materials. Companies can use this to develop more environmentally friendly and higher-performing food packaging solutions.
2. Strengthening Food Safety Standards
By introducing stricter migration limits and verification requirements, the regulations further raise the safety threshold for plastic food contact materials. This is significant for protecting consumer health and enhancing public confidence in plastic packaging.
3. Promoting Global Regulatory Harmonization
EU food contact materials regulations are often considered a global benchmark. This update may influence regulatory development in other regions (such as the US, Japan, and China), promoting global harmonization and convergence of plastic food safety standards.
4. Challenges and Opportunities for the Supply Chain
Raw material suppliers: need to ensure that the substances they supply meet EU purity requirements and certification standards.
Plastic processing companies: must adjust their production processes to ensure that additives are uniformly dispersed within permissible concentrations and meet migration testing requirements.
Food packaging manufacturers: can use the newly licensed substances to develop differentiated products, but will have to bear the additional costs of compliance testing.
Recommendations for Businesses
1. Update Technical Documents Promptly
Businesses using newly licensed substances should update their technical documents, including:
CAS number and purity certificate of the substance
Calculation of the concentration to be used in the final material
Migration test report conforming to SML (using the specified test medium)
2. Strengthen Supply Chain Communication
Clearly require upstream suppliers to ensure that purchased substances comply with EU licensing specifications. It is recommended to sign a quality assurance agreement stipulating liability and compensation for non-compliance.
3. Pay Attention to Exemptions and Restrictions
Pay special attention to the usage restrictions of various substances, especially:
Not applicable to infant formula/breast milk: If the product may be used for this purpose, substances with this restriction should be avoided.
Only applicable to non-fat foods: For packaging that may come into contact with oils, other suitable substances should be selected.
4. Plan Product Updates in Advance
If you plan to use newly licensed substances to improve existing products or develop new products, you should start R&D and testing as early as possible to seize market opportunities.
Conclusion: The Industry Needs to Actively Adapt to Regulatory Evolution
The EU's latest update to regulations on plastic food contact materials reflects both a response to scientific progress and a continued commitment to food safety and sustainability. For the plastic sheet, rod, and tube industry, this presents both challenges and opportunities.
The challenge lies in the potential for stricter compliance requirements to increase testing costs and extend product time-to-market. The opportunity lies in the fact that by adopting newly authorized substances, companies can develop higher-performance, more environmentally friendly products, meeting market demands for safe and sustainable packaging.
Recommendations for Industry Companies:
Establish a regulatory monitoring mechanism: Continuously track regulatory updates in the EU and other major markets, and plan ahead.
Invest in R&D capabilities: Strengthen research on the application of new substances and accumulate technological reserves.
Promote industry collaboration: Utilize platforms such as industry associations to jointly address compliance challenges and share best practices.