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EU plans to revise regulations on plastic materials in contact with food

Time：

2025-09-09

The European Union plans to revise the transitional measures in Regulation (EU) 2023/1442 regarding the use of salicylic acid or untreated wood powder/fiber in the manufacture of plastic materials and products. The draft is scheduled to be adopted and implemented in November 2025.

Recently, the European Union issued Notice G/SPS/N/EU/875, planning to revise the transitional measures in Regulation (EU) 2023/1442 regarding the use of salicylic acid or untreated wood powder/fiber in the manufacture of plastic materials and products. The draft regulation revises the transitional measures in Regulation (EU) 2023/1442 by adjusting the deadline for the European Food Safety Authority to determine the validity of authorization applications for "untreated wood flour or fiber". Through this revision, the applicant will be given reasonable time to complete their application.

The draft regulation is scheduled to be passed and implemented in November 2025.

Interpretation of the draft

01. Background

(1) Regulatory Basis

The European Commission Regulation (EU) 10/2011, issued on January 14, 2011, provides specific rules for plastic materials and products intended to come into contact with food. Annex I of this regulation establishes a list of EU substances that can be used to manufacture plastic food contact materials and products.

The European Commission Regulation (EU) 2023/1442, issued on July 11, 2023, revoked the authorization for two substances, "untreated wood powder and fiber" (FCM number 96) and "salicylic acid" (FCM number 121), effective August 1, 2023. This regulation provides a transitional measure allowing plastic materials and products that comply with the applicable provisions of Regulation (EU) No. 10/2011 before the entry into force of Commission Regulation (EU) 2023/1442 (if first placed on the market before February 1, 2025) to remain on the market until inventory is depleted. In addition, a transitional measure has been established to allow plastic materials and products manufactured using these substances to be put on the market after February 1, 2025, subject to specific conditions being met. These conditions include: the authorization application must be submitted before August 1, 2024, and the European Food Safety Authority must recognize the application as valid before February 1, 2025.

(2) The necessity of revision

At present, there are few applications submitted for authorization of "salicylic acid" and they have been recognized as valid by the European Food Safety Authority before February 1, 2025. However, in the case of "untreated wood powder or fiber" sourced from a specific tree species, all applicants have failed to submit the information deemed necessary for risk assessment by the European Food Safety Authority based on its administrative guidelines on substance applications for plastic food contact materials. In addition, there is significant uncertainty in the information required for the assessment of "untreated wood powder and fiber" by the European Food Safety Authority. In some cases, analytical testing may be necessary, but due to the long duration of these tests, it is difficult for the applicant to complete them on time, thus failing to meet the requirement of Article 2 (3) of Regulation (EU) 2023/1442 that the European Food Safety Authority must recognize the application as valid before February 1, 2025.

Considering the applicant's difficulty in submitting the information required for risk assessment by the European Food Safety Authority in a timely manner, and according to the application description, the use of "untreated wood powder and fiber" in plastic materials and products did not immediately raise safety concerns, it is necessary to modify the deadline for the European Food Safety Agency to recognize the validity of the application during the transition period, in order to provide the applicant with a reasonable but limited time to complete the application.

02. Amend Article 2 of Regulation (EU) 2023/1442 as follows:

(1) Replace the third paragraph with the following:

If the following conditions are met, plastic materials and products made from untreated wood powder or fibers sourced from salicylic acid or specific tree species can continue to be put on the market for the first time between February 1, 2025 and January 31, 2026:

(a) An authorization application for the substance has been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004 before August 1, 2024;

(b) This substance is used for the manufacture of plastic materials and products, and its use is limited to the expected conditions of use described in the application;

(c) According to Article 9 (1) (b) of Regulation (EC) No 1935/2004, the information provided to the European Food Safety Authority shall include a statement indicating that the application complies with the provisions of this paragraph.

Plastic materials and products that meet the conditions of sub paragraph 1 may continue to be put on the market for the first time after January 31, 2026, if the European Food Safety Authority has determined that the application referred to in sub paragraph 1 (a) is valid before that date. ”

(2) Replace the fourth clause with the following:

4. Plastic materials and products that meet the requirements of paragraph 3 may continue to be put on the market for the first time and may be sold on the market until the applicant withdraws the application, or until the European Commission makes an approval or refusal decision on whether to authorize the use of salicylic acid or untreated wood powder or fiber from specific tree species sources in accordance with Article 11 (1) of Regulation (EC) 1935/2004. ”

03. There are the following precautions for applicants regarding relevant materials:

Timely preparation of application materials: Although the revision has given more time, applicants should still prepare authorization application materials as soon as possible in accordance with regulatory requirements, especially for the information required for the risk assessment of "untreated wood powder or fiber", and plan analysis and testing work in advance to ensure the submission of a complete and accurate application within the prescribed time.

Pay close attention to regulatory updates: closely monitor the revision progress of relevant EU regulations and the guidance of the European Food Safety Authority, adjust application strategies and material content in a timely manner, and ensure that applications meet the latest requirements.

In the face of increasingly strict global control over food contact materials, Jiayu Testing has a professional testing technology team, equipped with advanced instruments and equipment, proficient in various regulatory standards, and specializes in providing FCM food contact material testing services for various food contact materials (such as plastics, coatings, metals, silicone, glass ceramic enamel, bamboo, paper, cardboard, etc.) in China, the United States, the European Union and its member states (France, Italy, Germany, etc.), Japan, South Korea and other countries to ensure that your products meet the regulatory requirements of various countries. Welcome to contact us at 400-9269-886!