China New Food Raw Materials approved by NHC

China new food raw materials were approved and introduced by the National Health Commission (NHC) on September 30, 2024. The products include not only new food ingredients but also new food additives and new food contact products for food packaging. The regulatory update outlined requirements in terms of safety assessments, production, and usage for the newly approved substances which included Nannochloropsis gaditana oil, D-psicose 3-epimerase, and C.I. Pigment Black 7, among others.

Key Highlights:

China New Food Raw Materials:

Nannochloropsis gaditana oil: Derived from Nannochloropsis gaditana, this oil, containing a high concentration of EPA (≥20g/100g), is approved for use as a food ingredient. It can be used to replace Fish Oil, Algal Oils, Synthetic Omega-s Supplements and Krill Oil. The use of Nannochloropsis gaditana oil in health supplements is particularly advantageous for consumers seeking natural, sustainable, and plant-based omega-3 options, supporting cardiovascular health, brain function, and reducing inflammation without relying on animal sources. However, due to limited safety data, it is not recommended for infants, pregnant women, and lactating women. The recommended daily intake is ≤2g. Proper labelling should be ensured to indicate the unsuitable populations and dosage limits.
Procyanidins: Extracted from the bark of the pine tree (Pinus pinaster Aiton), proanthocyanidins (≥50g/100g) are recognized as safe for consumption, though they are similarly restricted for sensitive populations like infants, pregnant women and lactating women. The recommended intake is ≤150mg/day. The content of procyanidins is calculated as 50g/100g, and if it exceeds this concentration, the intake should be adjusted accordingly. In food products, Procyanidins can be used to replace Synthetic Antioxidants, Cocoa Flavonoids, Vitamin E and it can also be used as a replacement for Resveratrol, Vitamin C, Coenzyme Q10 and Phytochemicals in Anti-Aging Supplements. By incorporating procyanidins, food and health products can achieve functional health benefits, particularly those focused on antioxidant properties, cardiovascular support, and anti-aging, while offering a more natural, plant-based ingredient alternative. Products containing procyanidins must include clear labelling requirements with daily intake limits to ensure consumer safety.

New Food Additive Varieties:

D-psicose 3-epimerase: This enzyme, derived from Bacillus subtilis, is approved for use in converting D-fructose into D- psicose, a process necessary in food manufacturing. The approval aligns with global standards, and its use is regulated under China’s national food safety standards for enzyme preparations.
2’-fucosyllactose，2’-FL and Lacto-N-neotetraose，LNnT: These oligosaccharides, prominent in breast milk, are approved as food nutrient fortifiers. Both substances are already allowed in infant formula by international regulatory bodies, including the US FDA and European Commission.
Sodium Ferrous Citrate: Approved as a source of iron in various food products, this nutrient enhancer complies with existing regulations for iron compounds in food products, ensuring its safe use across multiple food categories.

New Food-Related Product Varieties:

C.I. Pigment Black 7 (Carbon Black): C.I. Pigment Black 7, commonly known as Carbon Black, is a black pigment that is insoluble in water. It has been previously approved for use in paints, coatings, rubber, inks, and various plastic materials like polyethylene (PE) and polyvinyl chloride (PVC). The latest application expands its approved use to include polycyclohexylenedimethylene terephthalate (PCT) plastic materials and products intended for food contact. The substance is already approved by international bodies, including the FDA and the European Commission.
Sodium Hydroxide：Sodium hydroxide is a white crystalline powder that is highly soluble in water and used in various food contact materials. It has been previously approved for use in products like paints, coatings, rubber, and adhesives etc. This application extends its scope of use to include polyvinylidene fluoride (PVDF) plastic materials, which are used for food contact. Sodium hydroxide acts as a solvent in the production process of PVDF hollow fiber membranes. It helps dissolve other components and form membrane pores. This product’s safety and necessity have been recognized by international regulatory agencies, including the FDA and European Commission.
Dibutyl Sebacate: Dibutyl sebacate is a colorless, transparent liquid commonly used as an additive in paints, coatings, adhesives, and plastic materials like polystyrene (PS) and acrylonitrile-butadiene-styrene copolymer (ABS). The recent application allows its use in polyvinylidene fluoride (PVDF) plastic materials intended for food contact. Dibutyl sebacate is already permitted for use by various international bodies, including the U.S. FDA and the European Commission, making it a safe and necessary addition to food packaging materials.
2,4,8,10-Tetraoxa-3,9-diphosphaspiro [5.5]undecane,3,9-bis[2,4bis(1-methyl-1-phenylethyl)phenoxy]-：This chemical acts as an antioxidant, protecting packaging materials from yellowing or degradation. It is used as an additive in plastic materials like polyethylene (PE) and polypropylene (PP), and is now approved for use in adhesives for food-contact materials. The substance has a solid form at room temperature. By preventing material breakdown, it helps maintain the durability and quality of food packaging over time. It is also approved by the U.S. FDA and the Southern Common Market (MERCOSUR) for use in food-contact applications.
Copolymerof trimethoxyphenylsilane, methyltrimethoxysilane,andsilica：This copolymer acts as a key film-forming agent in coatings, providing excellent adhesion, scratch resistance, and anti-stick properties. It also enhances abrasion and corrosion resistance, making it ideal for food-contact coatings. It has previously been approved for use in food-contact paints and coatings by regulatory bodies such as the German Federal Institute for Risk Assessment and Japan’s Ministry of Health, Labour, and Welfare.
Benzene,ethenyl-,polymerwith 1,3-butadiene,hydrogenated: This copolymer serves as a base resin for food-contact coatings, offering improved antifouling and heat-sealing properties. Its durability makes it an excellent material for packaging that needs to maintain hygiene and integrity. The substance is approved for use by the US FDA and European Commission.

Implications for Manufacturers:

Implications for Food Manufacturers: Health food manufacturers should carefully review these new approvals to ensure compliance with China’s food safety laws. Proper labelling, especially for sensitive populations such as infants and pregnant women, is critical. Manufacturers must update their quality assurance protocols and labelling processes to avoid non-compliance with new regulatory requirements.
Implications for Packaging Manufacturers: Packaging manufacturers should ensure the safety of materials, including Carbon Black and Dibutyl Sebacate, used for food-contact applications. Compliance with China’s food safety standards and updating safety checks for packaging processes is essential.

Further information

Staying updated on regulatory changes is essential for manufacturers to maintain compliance and capitalize on the growing health food market in China.

Read the original NHC announcement on China New Food Raw Materials introduced by NHC.

Read our previous article on China health food 4 new dual-use substances.