EU Food Contact Regulations

On February 24, 2025, the European Union published RegULation (EU) 2025/351, which amends the following regulations:

- Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

- Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with food

- Regulation (EC) No 2023/2006 on good manufacturing practices for materials and articles intended to come into contact with food

At the same time, it repeals the old Regulation (EC) No 282/2008on recycled plastic materials.

Regulation (EU) 2025/351will officially take effect on March 16, 2025.

Main Amendments

[1] Amendments to Regulation (EU) No 10/2011 on Plastic Food Contact Materials and Articles

01. Definition Adjustments and “High Purity” Requirement

The definition of “additives” has been updated, and new definitions have been introduced for “plastic recycling processes,” “UVCB substances,” and “high purity.”

The regulation clarifies the requirements for substances of “high purity,” especially in terms of “non-intentionally added substances.”

New Article 3a — High Purity:

> “Substances used for the manufacture of plastic materials and articles shall be of high purity, meaning that all constituents correspond to their identity and contain only small amounts of non-intentionally added substances (NIAS). Such substances shall be consideRED of high purity if they meet one of the following conditions:

>

> 1. Comply with the specifications or restrictions set out in Table 1 of Annex I to this Regulation, where applicable;

> 2. Have been risk-assessed in accordance with Article 19 and found compliant;

> 3. Have undergone toxicological evaluation and are proven to be non-genotoxic, and assuming complete migration, no single substance migrates above 0.05 mg/kg of food;

> 4. Have not yet been assessed under points 2 or 3, but assuming complete migration, no single substance migrates above 0.00015 mg/kg of food.”

02. Clarification on Substance Use

The regulation emphasizes that only substances included in the EU authorized listmay be used in the manufacture of plastic materials and articles.

It specifies that substances not listedin the EU list may still be used under national legislationas polymer production aids, colorants, or solvents.

Additionally, it regulates the use of biocidal active substances.

> For biocidal active substances, only active substances used in biocidal products of product-type 4(as defined under Regulation (EU) No 528/2012) and authorized on the EU market may be used as additives in the manufacture of plastic materials and articles.

03. Updated Requirements for Materials and Articles

The regulation introduces updated restrictions for plastic materials and articles, specifies conditions for using recycled plastics, and requires that reusable food contact itemsmust not exhibit increased migration under intended use.

It also refines provisions on labeling, declarations of compliance, and supporting documentation.

New Article 14a — Labeling:

> Article 14a. Labeling

> 14.1Manufacturers or operators placing final plastic food contact articles intended for reuse on the market shall, in accordance with Article 15(7) and (8) of Regulation (EC) No 1935/2004, provide the following information to users:

> (a) Appropriate instructions intended to slow down the aging of the article;

> (b) A description of observable changes that may indicate aging of the material or article;

> (c) Warnings for situations where specific damage or foreseeable misuse may increase migration or render the article unsuitable for food contact.

>

> 14.2When plastic materials and articles are offered for sale to consumers at the retail stage, instructions for use must be provided for the final consumer. If the plastic materials and articles are made using substances listed in the EU authorized list that have restrictions in Column 10 of Table 1 in Annex I of Regulation (EU) No 10/2011, such restrictions may relate to:

> - Specific foods or food groups,

> - Contact time and/or temperature,

> - Heating conditions (e.g., use in ovens or MICrowaves).

>

> The instructions shall indicate these restrictions and provide sufficient information to the consumer to avoid use under non-compliant conditions.

Amended Article 16 — Supporting Documents:

> Manufacturers must provide documentation on substance composition and purity upon request from the competent authorities.

04. Amendments to Compliance testing

Migration testing rules have been refined — including adjustments to surface-to-volume ratioapplications and calculation methods.

Standards for compliance testing are improved to regulate the choice of analytical methods, number of tests, and criteria for evaluation.

[2] Amendments to Regulation (EU) 2022/1616 on Recycled Plastic Materials and Articles

Recycled plastic materials and articles must meet the requirements specified in Chapters II, III, and Vof Regulation (EU) No 10/2011.

However, Article 8(1) of (EU) No 10/2011 does notapply to contaminants in the input and outputof the purification process.

The quality and purityof input and output substances in the purification process must comply with the requirements of Regulation (EU) 2022/1616.

[3] Amendments to Regulation (EC) No 2023/2006 on Good Manufacturing Practices (GMP)

The regulation strengthens the quality assurance systemfor recycling facilities and introduces new requirements for quality assessment during recycling processes.

It also standardizes plastic reprocessing procedures, covering all stages such as collection, storage, transportation, and prevention of cross-contamination.

Transitional Measures

For Plastic Materials and Articles

Plastic materials and articles compliant with previous regulations that are first placed on the market before September 16, 2026, may continue to be sold until stocks are exhausted.

For Intermediate Materials

Intermediate materials that comply with old regulations but are placed on the market after December 16, 2025, and do not comply with Regulation (EU) 2025/351, must indicate this non-compliance in their declaration of compliance.

Such materials may only be usedin the manufacture of plastic materials and articles placed on the market before September 16, 2026.

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JJR Reminder

The EU has officially issued Regulation (EU) 2025/351, revising and repealing four regulations related to food contact plastic materials and articles.

This revision focuses on key aspects such as plastic purity, biocidal substances, recycled plastic compliance, and good manufacturing practices.

Relevant enterprises should:

- Carefully select raw materials to ensure compliance with the new “high purity” requirements;

- Optimize recycling and production processes to enhance product quality;

- Strengthen quality management systems and controls at every stage;

- Standardize and update declarations of compliance and supporting documentation to ensure accuracy and completeness.