Services: Electrical testing and certification, environmental or chemical testing

language
- English
- 中文

400-9269-886

NEWS CENTER

Industry News

Company News

Knowledge

The European Food Safety Authority (EFSA) clarifies the safety of styrene for use in food contact materials

Time：

2025-08-11

The European Food Safety Authority (EFSA) has released an assessment confirming that styrene does not have genetic toxicity upon oral exposure, and the European Commission's proposed specific migration limit (SML) of 40 µ g/kg for styrene in plastic FCM does not raise safety concerns.

The European Food Safety Authority (EFSA) recently released its latest scientific assessment on the impact of styrene use in food contact materials (FCM) on public health. This assessment confirms that styrene does not have genetic toxicity upon oral exposure, and the European Commission's proposed specific migration limit (SML) of 40 µ g/kg for styrene in plastic FCM does not raise safety concerns. This conclusion is expected to become an important basis for industry regulation.

01. Background of EFSA's reassessment of styrene

Styrene is authorized by the EU Plastic Regulation (EU 10/2011) for the production of plastic FCM without migration or other restrictions. In 2019, the International Agency for Research on Cancer (IARC) published a monograph stating that styrene and its main metabolite, styrene-7,8-oxide (SO), were classified as Group 2A "possibly carcinogenic to humans". Due to the potential impact of this conclusion on the existing authorization for styrene, in December 2018, the European Commission requested EFSA to re evaluate the relevant evidence to determine whether it affects the safety of styrene exposure in food contact materials.

02. Evaluation Method and Conclusion

To eliminate the aforementioned uncertainties, EFSA conducted a rigorous review of in vivo genotoxicity studies in this reassessment, taking into account third-party information, targeted literature searches, and the 2019 IARC special report. The results showed that when styrene was orally administered to the maximum tolerated dose (300 and 500 mg/kg bw, respectively) in mice and rats, different endpoint and target tissue results indicated that styrene did not induce genotoxic effects.

The EFSA expert group has come to a clear conclusion that styrene does not have genetic toxicity after oral exposure; When using styrene monomer in the manufacturing of food contact materials, there will be no safety hazards if it meets the European Commission's proposed SML of no more than 40 μ g/kg. Based on this, the European Commission may introduce specific migration limits for styrene in plastic regulations after considering the opinions of EFSA.

03. Regulatory requirements for styrene in China and the United States

At present, there are certain differences in the regulatory requirements for styrene between China and the United States. China adopts a comprehensive positive list management model for food contact materials. There are no specific regulatory requirements for styrene additives or monomer residues in GB 9685-2016 "Additives for Food Contact Materials and Products" and GB 4807.7-2023 "Plastic Materials and Products for Food Contact". There are currently no specific regulatory requirements in the EU plastic regulation EU 10/2011.

In the United States, the Federal Regulations (21 CFR) stipulate that the residual amount of styrene monomer in styrene polymers used in food contact must not exceed 0.5%.

04. Compliance Suggestions

The release of EFSA's evaluation opinion provides a clear scientific basis for the safety of styrene in the global food contact materials field, which will help promote the development and standardization of regulations in different countries and regions.

It is recommended that enterprises closely monitor the regulatory dynamics of styrene in the mainstream market, strengthen supply chain management while complying with the latest regulatory requirements, and ensure the safety of food contact materials through active compliance management and risk control.

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!