Recently, the National Health Commission approved (3R,3'S) -dihydroxy-beta-carotene (Meso-zeaxanthin, CAS No. 31272-50-1) as a new food ingredient. Previously, (3R,3'R) -dihydroxy-beta-carotene (zeaxanthin, CAS No. 144-68-3) had been approved as a new food ingredient. Foodmate will introduce what the two ingredients are, how they are labeled in the food ingredient list and the approved use in various countries for your reference.

1. What are zeaxanthin and Meso-zeaxanthin？

Zeaxanthin, Meso-zeaxanthin, and Lutein (CAS No. 127-40-2) are all natural carotenoids that together make up the macular pigment of the retina. The so-called macular pigments are substances that protect retinal cells by filtering and absorbing high-energy, damaging blue light. Lutein exists in the periphery of the macula, zeaxanthin exists in the periphery of the macula, and Meso-zeaxanthin exists in the center of the macula. According to research, macular pigment not only can absorb and filter blue light, but also protect retinal nerve cells from photo-oxidation damage through antioxidant effect . At present, many commercially lutein ester products contain zeaxanthin and lutein raw materials.

2. How to identify in the food ingredient list?

According to the "The Administrative Measures for the Review of the Safety of New Food Ingredients" article 20 provisions: food containing new food ingredients, the labeling should comply with national laws, regulations, food safety standards and the National Health Commission announcement requirements. According to this regulation, the name of new food ingredients in the food ingredient list should also comply with the requirements of the announcement to avoid misleading consumers. Zeaxanthin and Meso-zeaxanthin are not the specification names in the announcement, so it is not recommended that only Zeaxanthin or Meso-zeaxanthin be labeled.

3. Approval in food by country/organization

(1）China

On May 31, 2017, the National Health Commission issued the "Announcement on 10 kinds New Food Ingredients including Shea Butter", approving (3R,3'R) -dihydroxy-beta-carotene from marigold flowers as a new food ingredient, and the recommended serving size of ≤4 mg/day (measured in (3R,3'R) -dihydroxy-beta-carotene).

On March 13, 2024, the National Health Commission issued the "Announcement on 23 kinds New Food Ingredients including Dendrobium bulbs", approving (3R,3'S) -dihydroxy-beta-carotene from marigold flowers as a new food ingredient, with the recommended serving size of ≤8 mg/day (measured in (3R,3'S) -dihydroxy-beta-carotene).

(2）European Union

According to the "Authorization of the placing on the market of synthetic zeaxanthin as a novel food ingredient pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council" (2013/49/EU), synthetic zeaxanthin is permitted as an ingredient in food supplements at a recommended dietary intake of 2 mg/day. The synthetic zeaxanthin is produced by a multi-step chemical synthesis of small molecules and should be labeled "synthetic zeaxanthin" on food labels.

(3）United States

According to FDA's "GRAS Notices", there are 2 each of zeaxanthin and Meso - zeaxanthin that the FDA considers acceptable. Among them, zeaxanthin (GRN No. 639) from marigold source can be used for infant food, candy, cereals, dairy products, soups and beverages etc., with a recommended serving size of 300 mg/serving; Zeaxanthin (GRN No. 588) from chili powder can be used in baked goods and baking mixtures, beverages and beverage bases, breakfast oats, chewing gum, etc., with a recommended serving size of 0.3 to 3 mg/serving. Meso-zeaxanthin (GRN NO. 481), approved in 2014 can be used in a variety of foods and beverages, but there is no recommended serving size; Meso-zeaxanthin (GRN No. 550) approved in 2015 can be used in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products, etc., with a recommended serving size of 0.18 to 1.8 mg/serving.

(4) JECFA

The Joint Expert Committee on Food Additives (JECFA) of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) evaluated the safety of lutein and zeaxanthin from marigold sources, with an ADI (Acceptable Daily Intake) value of 0-2 mg of lutein and zeaxanthin per kg of body weight per day. According to the “Codex General Standard for Food Additives” (CXS 192-1995), zeaxanthin (synthetic) can be used as a food additive (colorant) in flavored liquid milk beverages, at a maximum use level of 100mg/kg.

4. Summary

In summary, it can be seen that zeaxanthin or Meso-zeaxanthin has been approved to be used in general food products in China, the European Union, the United States and JECFA. However, due to the differences in preparation methods and use in various countries, when adding to food, attention should also be paid to its compliance.