PHA material (Poly-3-hydroxybutyrate-co-3-hydroxyhexanoate, PHBH) produced by Bluepha successfully passed the China Food Contact Materials Certification. This makes Bluepha the world’s first company that can mass-produce, sell, and use food-grade PHA (PHBH) raw materials in China, the US, and the EU. The National Health Commission of the People’s Republic of China (NHC) published announcement No. 6 of 2014 on its official website on December 13, 2024.
The specific approval details are as follows:
New food contact resin
|
Name |
Poly-3-hydroxybutyrate-co-3-hydroxyhexanoate |
|
Source |
Cupriavidus necator H16 |
|
Donor |
- |
|
CAS number |
147398-31-0 |
|
General Category Name |
PHA |
|
Range of application |
Plastic |
|
SML/(mg/kg) |
0.05(Butenoic acid) |
|
QM/(mg/kg) |
- |
|
Remark |
The PHA plastic materials and products produced using this substance as a raw material must not be used at temperatures exceeding 100°C. They are also not allowed to be used in the production of materials and products intended for contact with food for infants and young children. The above usage restrictions must be labeled in accordance with the provisions of GB48061. |
According to Article 37 of the Food Safety Law of the People's Republic of China, when new food raw materials are used to produce food, or new food additives or food-related products are produced, safety assessment materials for the relevant products must be submitted to the administrative health department of the State Council. After a systematic and rigorous evaluation process, the products may be officially included in the list of GB4806.7 National Food Safety Standard for Food Contact Plastics and Products, and only then can they be used for food contact purposes.
As the first company in China to file for the certification of this material, Bluepha has accumulated extensive physical, chemical, and safety data through years of research and development. Throughout the entire application process, CIRS and Bluepha worked in close cooperation, preparing detailed submission materials, from product submission acceptance, and official consultations, to the final announcement, the process was completed in about one year.
Considering that Bluepha's PHA series products have already been included in the EU Food Contact Materials list and have passed the US FDA food contact materials certification, Bluepha is now the world’s first company that can mass-produce, sell, and use food-grade PHA (PHBH) raw materials in China, the US, and the EU.
About CIRS
The Food Division of CIRS was established in 2012 and has assisted over 1,000 Chinese and international food and related enterprises in completing "one-stop" food compliance work. We have numerous successful cases in the fields of novel food, synthetic biology food, US GRAS certification, EU Novel Food, health food, and special foods.
Leveraging our professional technical expertise, diverse resources, and a global network, we offer our clients services including novel food applications (new food raw materials, new food additives, new food-related products, including synthetic biology varieties), US GRAS certification, EU Novel Food applications, health food registration and filing, special medical-purpose formula food registration, infant formula registration, general food, laboratory services, regulatory information tracking, and training. We assist clients to achieve product compliance, quickly gain market access, and enhance their competitiveness.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
