In the era of mobile phone popularity, the eye load of the "China on the fingertips" nation is heavier than ever before, and eye health problems are particularly prominent in this era. Lutein is favored by Chinese consumers because of its visual protection function, which is also an opportunity for foreign companies. Then What is the compliance path for lutein-containing foods to enter China? Here is a brief introduction for your reference.

1. What is lutein?

Lutein is a carotenoid that is distributed in various tissues of the eye. Its concentration is highest in the macular region of the retina, making it the main pigment constituting the macular region of the retina. However, the body cannot synthesize lutein itself and can only be supplemented by external nutrients. There is an effective hydrolysis esterification system in the human digestive tract, which can decompose lutein ester and release free lutein during digestion, so lutein ester is one of the safe sources of lutein.

Lutein absorbs blue light and minimizes oxidative damage caused by blue light, thereby protecting visual function. It also has a strong antioxidant capacity, can effectively resist the human free radicals caused by cell and organ aging damage. Many brands on the market now have launched lutein products that claim to relieve eye fatigue, resist blue light, and prevent myopia. 

2. The approved use of lutein in China

Lutein is approved for use as a nutritional fortifier and food additive in China, as follows.

2.1 Nutritional fortifier

According to China's national standard for nutritional fortifier, lutein can be used as a nutritional supplement for infant formula food, formula food for older infants and toddlers, infant formula food for special medical purposes, milk powder (for children only).

As lutein is not included in the list of health food accessories in China, it can only be used as a registered health food raw material, and in the “List of Health Food Non-nutritional Health Care Products' health Function Claims (2023 Edition)”, the eye-related function claims currently have an item of "relieving visual fatigue".

2.2 Colorants

According to China's food additive safety national standard, lutein can be used as a colorant, including milk, frozen drinks, jam, candy, instant rice and noodle products, baked goods, beverages, jelly, etc.

3. Export compliance tips

According to China's national food safety standards, lutein can be used as a colorant and nutritional fortifier, and attention should be paid to its permitted product types and limit requirements when used. When using, be careful not to carry out functional claims, because according to Chinese regulations, in addition to health products approved by the State Administration for Market Regulation (SAMR) with a "little blue hat" health food label, other ordinary food can not promote the efficacy of the product, as it is illegal to promote health functions if not approved by the regulatory authorities. In the "List of non-nutritional supplements that allow health foods to claim health functions (2023 version)", there is only one item related to the eyes: "relieving visual fatigue".

Overseas enterprises intending to export should pay attention to the compliance of lutein use and the function claim of lutein products. Foodmate can provide professional services on the compliance of lutein products exported by overseas enterprises to ensure the smooth export of products. If need any help, please contact us via global_info@foodmate.net.