Comprehensive Strengthening of China’s DEHP Regulations
Comprehensive Strengthening of China’s DEHP Regulations
Regulatory Analysis Across Electronics, Toys, Food, and Medical Sectors
DEHP plasticizers are widely used in various plastic products across multiple industries, including electronics, children’s toys, food contact materials, and medical devices. In response to increasing health and environmental safety requirements, mainland China has continuously strengthened its regulatory standards for phthalate plasticizers such as DEHP in recent years, gradually tightening relevant restriction requirements through management across different sectors.
1. Electronics and Electrical Equipment
GB 26572-2025 "Requirements for restricted use of hazardous substances in electrical and electronic products", the revised China RoHS mandatory standard (scheduled for implementation in August 2027), formally includes four phthalates—DEHP, DBP, BBP, and DIBP—in the list of restricted substances.
The regulation requires that the content of the above substances in homogeneous materials shall not exceed 0.1%, and it further strengthens requirements on:
- Disclosure of hazardous substance information
- Technical documentation retention and traceability management
Overall, the regulatory trend is evolving from simple concentration limits toward full supply-chain transparency.
2. Toy Sector
The GB 6675-2025 "Safety of toys" standard was issued in October 2025 and is expected to take effect on November 1, 2026. It applies to toys for children under 14 years old.
For accessible plastic materials, it explicitly restricts:
- Four phthalates: DEHP, DBP, BBP, and DIBP
- Total content not exceeding 0.1%
3. Food Contact Materials
For food contact materials, the main applicable standards include:
- GB 4806.7-2023 "National food safety standard — Food contact plastic materials and articles"
- GB 4806.13-2023 "National food safety standard — Food contact composite materials and articles"
- GB 31604.30-2016 "National food safety standard — Food contact materials and articles — Determination and migration of phthalate esters"
Among them, GB 31604.30-2016 provides analytical methods (GC-MS) covering 18 types of phthalates, serving as a technical basis for migration and residue analysis in food contact materials.
4. Medical Devices and Related Applications
For medical PVC materials, the key standards include:
- GB 14232.1-2020 "Plastics collapsible containers for human blood and blood components", specifying DEHP leachable limit ≤ 10 mg/100 mL
- GB 15593-2020 "Polyvinyl chloride plastics for blood transfusion and infusion equipments", specifying DEHP leachable limit ≤ 15 mg/100 mL
As the potential health and environmental risks of DEHP attract increasing attention, seeking alternative materials is a development direction for PVC medical devices. Annex Table A.1 of the GB 15593-2020 standard lists several kinds of non-phthalate plasticizers such as TOTM and DINCH. DINCH has become one of the most representative alternatives with its excellent safety performance and high compatibility. Currently, it has been applied to medical products like blood bags, infusion sets, and dialysis tubing sets, which is an important trend of PVC plastic medical device applications.
▲Table A.1 in Appendix A of GB 15593-2020
Author: Liu Li | QC Supervisor | Zhongshan R&D Center
Illustrator: Ray Chang | New Business Specialist | Office of President
Managing Editor: August Chang | Project Manager | Office of President
Publication: 202605W4
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