Astaxanthin-rich oleoresin from Haematococcus pluvialis algae: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food supplements as defined in Directive 2002/46/EC excluding infants and young children: 2,3 mg astaxanthin per day for children 3 to less than 10 years of age
• Food supplements as defined in Directive 2002/46/EC excluding infants and young children: 5,7 mg astaxanthin per day for adolescents 10 to less than 14 years of age
• Food supplements as defined in Directive 2002/46/EC excluding infants and young children: 8 mg astaxanthin per day for general population older than 14 years of age

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Astaxanthin rich oleoresin from Haematococcus pluvialis algae’ The labelling of food supplements containing Astaxanthin rich oleoresin from Haematococcus pluvialis algae shall bear a statement that they should not be consumed: (a) if other food supplements containing astaxanthin esters are consumed on the same day (b) by infants and young children under 3 years of age (c) by infants and children under 10 years of age (12) (d) by infants, children and adolescents under 14 years of age (12).

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description:

Astaxanthin is a carotenoid produced by Haematococcus pluvialis algae. Production methods for the growth of the algae are variable; using ‘closed’ systems exposed to sunlight or strictly controlled illuminated light alternatively open ponds may be used. The algal cells are harvested and dried; the oleoresin is extracted using either super critical CO2 or a solvent (ethyl acetate). The Astaxanthin is diluted and standardized to 2,5 %, 5,0 %, 7,0 %, 10 %, 15 % or 20 % using olive oil, safflower oil, Sunflower oil or MCT (Medium Chain Triglycerides).

Characteristics/Composition:

Fat: 42,2-99 %

Protein: ≤ 4,4 %

Carbohydrate: ≤ 52,8 %

Fibre: < 1,0 %

Ash: ≤ 4,2 %

Specification of Carotenoids % w/w

Total Astaxanthins: 2,9-11,1 %

9-cis-astaxanthin: 0,3-30,0 %

13-cis-astaxanthin: 0,2-7,0 %

Astaxanthin monoesters: 66,7-91,5 %

Astaxanthin diesters: 0,16-32,5 %

Beta-Carotene: 0,01-0,3 %

Lutein: ≤ 1,8 %

Canthaxanthin: ≤ 1,30 %

Microbiological criteria:

Total aerobic bacteria: < 3 000 CFU/g

Yeast and Moulds: < 100 CFU/g

Coliforms: < 10 CFU/g

E. coli: Negative

Salmonella: Negative

Staphylococcus: Negative

Notes

(12) Depending on the age group the food supplement is intended for.

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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