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German BfR updates multiple recommendations for food contact materials: involving rubber, thermoplastic vulcanizing rubber (TPV)


Time:

2026-07-06

The German Federal Institute for Risk Assessment (BfR) has updated several recommendations for food contact materials, effective from June 1, 2026. It mainly involves rubber materials and has released a special specification for thermoplastic vulcanizing rubber (TPV) for the first time.

The German Federal Institute for Risk Assessment (BfR) recently officially released Announcements No. 230 and No. 231, updating several food contact material recommendations. The updates primarily concern rubber materials and include the first-ever specialized specifications for thermoplastic vulcanizates (TPV). The new recommendations will take effect on June 1, 2026.

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XXI

 

Natural rubber and synthetic rubber

1. The structure and composition of the XXI proposal have been updated, covering four major categories: natural rubber, synthetic rubber, latex, and TPV. According to the purpose and material of the product, it is divided into four standards, namely: General Basic Specification for Rubber Products (XXI), General Food Contact Rubber Products (XXI/1), Special Purpose Rubber Products (such as pacifiers and teethers) (XXI/2), and Thermoplastic Vulcanized Rubber TPV Food Contact Products (XXI/3) (newly released).

2. Update the new substance application link;

3. Add aluminum silicate filler with CAS number 0092704-41-1 to the license list of starting materials, additives, and production aids in Table 1.

4. Clearly state in Table 1 of Recommendation XXI that "QMA" refers to the maximum allowable migration per unit area as stipulated in Regulation (EU) No 10/2011

 

XXI/1

 

Consumer goods for food contact based on natural and synthetic rubber

1. The name of the proposal has been updated to "Food contact consumer goods based on natural and synthetic rubber";

2. Delete the paragraph about the combination of rubber and other copolymers;

3. Remove duplicate headings from Table 1.

 

XXI/2

 

Special daily consumer goods based on natural and synthetic rubber and latex from natural and synthetic rubber (original special category)

1. The name of the proposal has been updated to "Special Daily Consumer Goods Based on Natural and Synthetic Rubber and Natural and Synthetic Rubber Latex (formerly Special Category)".

 

 

XXI/3

 

Daily consumer goods made of thermoplastic vulcanizate (TPV)

XXI/3 First release.

1. Scope of application: Suitable for consumer goods made of thermoplastic vulcanized rubber (TPV) and expected to come into contact with food.

2. Definition of Thermoplastic Vulcanized Rubber (TPV): TPV is a polymer formed by dynamic vulcanization and cross-linking of thermoplastic materials and ordinary rubber, such as TPV - (PP+EPDM). Untreated thermoplastic elastomers (TPE) are not within the scope of application of this recommendation document.

3. Migration and application restrictions: Migration conditions and category classification should be implemented in accordance with Recommendation XXI/1. The testing should be conducted on fully crosslinked TPV products.

4. Raw material requirements:

(1) Thermoplastic part: Starting materials (monomers), additives or processing aids, subject to the provisions of Regulation (EU) No 10/2011 on plastics. But only TPVs made from the monomers listed in Table 1 of Recommendation XXI/3 for the thermoplastic part are within the scope of application of this recommendation.

(2) Rubber part: shall comply with the provisions of Proposal XXI and XXI/1.

(3) Crosslinking agents: limited to the commonly used crosslinking agents listed in Table 1 of XXI/3. The allowed crosslinking agents are listed in Table 1 of Proposal XXI/3. The current list is valid until May 31, 2029, and subsequent new substances need to be reapplied to BfR in accordance with EFSA guidelines.

5. Finished product requirements: It must meet the requirements of XXI/1 rubber and the peroxide value must be negative.

 

XXXV

 

A copolymer composed of ethylene, propylene, butene, vinyl esters, and unsaturated fatty acids, as well as their salts and esters

1. Delete the content of the original section B.

2. Add an explanation stating that when producing thermoplastic vulcanizing rubber (TPV), reference can be made to Proposal XXI/3.

 

 

The BfR proposal is an important component of the framework system for food contact materials in Germany, and it is recommended that relevant companies start compliance work as soon as possible. Jiayu Testing, as a professional third-party testing and certification service organization, has qualifications such as CMA, CNAS, CPSC, CCC, and has obtained laboratory accreditation from multiple authoritative certification institutions at home and abroad. It 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 coatings, silicone rubber, plastics, metals, glass ceramic enamel, bamboo, wood, paper and cardboard) 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
 

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