New plastics authorized in food contact packaging: what manufacturers and food industry must review

Key data

Plastic packaging manufacturers and the entire food chain have a new review obligation following the publication of Regulation (EU) 2026/2412 on 29 October 2026. This regulation modifies Annex I of Regulation (EU) 10/2011, which is the European reference that regulates which substances can be used in plastics intended to be in contact with food, under what conditions and with what migration limits.

This is not a minor procedural change: it directly affects the formulations of materials, the technical documentation that must accompany each product and the declarations of conformity that manufacturers deliver to their customers in the food chain.

What does this regulation establish?

Regulation (EU) 10/2011 is the European framework regulation that establishes which substances can be used in the manufacture of plastic materials and articles intended to come into contact with food. Its Annex I contains the positive list of authorized substances, together with their specific migration limits and applicable conditions of use.

The new Regulation (EU) 2026/2412 updates that Annex I with the following specific changes:

• Update of the list of authorized substances: the substances that can be legally used in the manufacture of plastics for food contact are modified.
• Review of migration limits: the maximum specific migration limits applicable to certain substances are updated.
• New conditions of use: specific conditions are established or modified under which certain authorized substances may be used.

This modification requires manufacturers to compare their current formulations with the new version of Annex I to detect any mismatches before the effective application date.

Economic and operational impact

The impact of this regulation is not only documentary: it has direct operational and economic consequences for several layers of the value chain.

• Formulation review: packaging manufacturers using substances affected by the changes will have to reformulate their products or seek authorized alternatives, with the development and validation costs that this entails.
• Update of declarations of conformity: each batch or type of plastic material in contact with food must be accompanied by an updated declaration of conformity. If the regulatory framework changes, the previous declaration becomes outdated and is no longer valid.
• Risk of market withdrawal: products that do not comply with the new requirements may be withdrawn from the market by the competent authorities, with the reputational and economic cost that this entails.
• Administrative sanctions: non-compliance may result in administrative sanctions, the specific amount of which will depend on the national legislation of each Member State.
• Impact on the food chain: food operators who purchase packaging from third parties must verify that their suppliers have updated their technical documentation, or assume the risk of working with non-compliant materials.

Who does it affect?

• Manufacturers of plastic packaging and materials for food contact: they are the most directly affected, as they must review formulations and update declarations of conformity.
• Food industry (food manufacturers, processors, packagers): they must verify that the materials they use comply with the new regulatory framework and require updated documentation from their suppliers.
• Distributors of packaged food: although they do not manufacture the packaging, they may be affected if they market products with non-compliant materials.
• Quality and regulatory compliance managers in food and packaging sector companies.
• Technical advisors and food safety consultants who manage the conformity documentation of their clients.

Practical example

A manufacturer of plastic trays for packaging fresh meat currently uses a formulation that includes a substance which, following the modification of Annex I, has a new specific migration limit that is more restrictive or revised conditions of use.

In that case, the company must:

1. Identify whether the substance remains on the positive list and under what conditions.
2. Verify whether its current formulation exceeds or not the new migration limit through laboratory testing if necessary.
3. Update the product's declaration of conformity to reflect compliance with Regulation (EU) 2026/2412.
4. Communicate the change to its food industry customers, who in turn must update their own supplier documentation.

If it does not act before the effective application date, the product could be considered non-compliant in an inspection, with risk of market withdrawal and administrative sanction.

What should companies do now?

1. Identify the effective application date: consult the full text of Regulation (EU) 2026/2412 on EUR-Lex to know the exact adaptation period, which has not been specified in the published summary.
2. Audit plastic materials in use: review all current formulations of packaging and materials in contact with food and compare them with the new Annex I of Regulation (EU) 10/2011.
3. Detect affected substances: identify which substances have changed status, have seen their migration limits modified or have new conditions of use.
4. Update declarations of conformity: all declarations of conformity must reflect compliance with Regulation (EU) 2026/2412 before the application date.
5. Require updated documentation from suppliers: food operators must require their packaging suppliers to certify compliance with the new regulation through updated declarations of conformity.
6. Consult with a food safety or regulatory affairs specialist if the review detects affected substances that require reformulation or additional testing.

Official source

Consult complete regulation on official source

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202602412