Update! EU Food Contact Plastics Regulation (EU) 2025/351 released

On February 24, 2025, the EU released Regulation (EU) 2025/351, which amends Regulation (EU) No 10/2011 on Food Contact Plastic Materials and Articles, Regulation (EU) 2022/1616 on Recycled Plastic Materials and Articles, and Regulation (EC) No 2023/2006 on Good Manufacturing Practice for Food Contact Materials and Articles, and abolishes the old version of Regulation (EC) No 282/2008 on Recycled Plastics. Regulation (EU) 2025/351 will officially take effect on March 16, 2025.

The main revisions are as follows:

1. Revision of Regulation (EU) No 10/2011 on Plastic Materials and Articles in Contact with Food

#01

"Definition Adjustment and "High Purity" Requirements"

The definition of "additive" is updated, and the definitions of "plastic recycling", "UVCB substances" and "high purity" are added. The requirements for "high purity" substances are clarified, and the requirements for "high purity" substances are clearly defined from the perspective of "non-intentionally added substances".

New Article 3a High Purity:

“Article 3a High Purity Substances used in the manufacture of plastic materials and articles shall be of high purity, in which all components are consistent with their identities, and only contain a small amount of unintentionally added substances. These unintentionally added substances shall be considered as high purity substances if they meet one of the following conditions: 1. Comply with the specifications or restrictions (if any) specified in Table 1 of Annex I of the Regulation; 2. Conduct risk assessment in accordance with Article 19 of the Regulation and comply with its provisions; 3. Have undergone toxicological evaluation and genotoxicity has been excluded. And based on the assumption of complete migration, the migration amount of any substance will not exceed 0.05 mg/kg food; 4. Have not been evaluated in accordance with Items 2 or 3, but based on the assumption of complete migration, the migration amount of any substance will not exceed 0.00015 mg/kg Food. "

#02

"Detailed regulations on the use of substances"

Emphasis that only substances included in the EU authorized substance list can be used in the manufacture of plastic materials and products; clearly pointed out that substances not covered in the EU list can be used as polymer production aids, colorants, solvents, etc. in the production of plastic materials and articles subject to national laws; regulate the use of functional substances in biocides.

Regarding functional substances in biocides: "According to Regulation (EU) No 528/2012 of the European Parliament and of the Council, the active ingredients used in biocides (product category 4) sold on the EU market can be used as additives in the manufacture of plastic materials and products."

#03

"Updates to requirements for materials and products"

Specify that plastic materials and products should meet relevant restrictions and clarify the conditions for the use of recycled plastics; for reusable food contact products, ensure that their composition and design will not increase the migration of components when used in accordance with the instructions; improve the relevant provisions on labels, compliance declarations and supporting documents.

New Article 14a Labelling: "Article 14a Labelling 14.1 The manufacturer or other operator responsible for placing finished plastic food contact articles on the market for reuse shall, in accordance with Article 15(7) and (8) of Regulation (EC) No 1935/2004, provide the following information to its users: (a) appropriate instructions designed to slow down the ageing of the article; (b) a description of observable changes in the article which may indicate ageing of the article or the material; (c) a warning in the event of specific damage or foreseeable misuse which would lead to increased migration or to the article becoming unsuitable for further contact with foodstuffs. 14.2 In accordance with Article 15(1) of Regulation (EC) No 1935/2004, plastic materials and articles sold or supplied to consumers at the retail level, where they have been made with substances included in the list of authorised substances, shall be accompanied by instructions for use directed to consumers of the finished food contact article. Column 10 of Table 1 of Annex I to Regulation (EU) No. 10/2011 lists restrictions related to one or more of the following elements: - specific foods or food groups, - contact time and/or temperature, - and/or heating conditions, such as oven and microwave use. The instructions for use should mention the restrictions and provide consumers with sufficient information to avoid using the product under conditions that do not comply with such restrictions. "

Revised Article 16 Supporting Documents: "The manufacturer shall provide material composition and purity documents upon request by the competent authority."

#04

"Revisions related to compliance testing"

Adjust the migration test rules, optimize the application of surface volume ratio, and revise the calculation method of test results; improve the compliance test standards, standardize the selection of analytical methods, the number of tests and the evaluation criteria of results.

2. Revision of Regulation (EU) 2022/1616 on Recycled Plastic Materials and Articles

Clarify that recycled plastic materials and articles shall meet the requirements specified in Chapter II, Chapter III and Chapter V of (EU) No 10/2011. In addition, it is also stipulated that Article 8(1) of (EU) No 10/2011 does not apply to pollutants in the input and output of the purification process, and the quality and purity of the input and output substances in the purification process shall comply with the requirements of (EU) 2022/1616.

3. Revise the Good Manufacturing Practice Regulation (EC) No 2023/2006 on Food Contact Materials and Articles

Improve the requirements for the quality assurance system of recycling facilities, add relevant provisions for the quality assessment stage of the recycling process; standardize the plastic reprocessing process, covering all aspects such as waste collection, storage, transportation and prevention of mixed contamination.

Transitional measures

For plastic materials and articles:

Plastic materials and articles that comply with the old regulations and are first placed on the market before September 16, 2026 can continue to be sold until the inventory is exhausted.

For intermediate materials:

Intermediate materials that comply with the old regulations are put on the market for the first time after December 16, 2025, but do not comply with Regulation (EU) 2025/351. The substance or product must indicate in the accompanying declaration of conformity that it does not comply with the regulation and can only be used to manufacture plastic materials and products that are put on the market before September 16, 2026.

Warm reminder

The European Union has officially promulgated Regulation (EU) 2025/351, which has revised and abolished the original four regulations closely related to food contact plastic materials and products. This revision focuses on key areas such as plastic purity, biocides, recycled plastic compliance, and production specifications. Relevant companies should pay close attention to these new changes and new requirements. Specifically, companies need to strictly screen raw materials to ensure that they meet the "high purity" requirements of the new regulations; recycled plastic-related companies should continue to optimize production processes to improve product quality; further improve the quality control system and strengthen quality control at all links; at the same time, standardize relevant compliance documents such as product declarations of conformity to ensure the accuracy and completeness of the document content.