On 1 August 2023, the EU Commission published implementing Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’. The new Regulation extends the conditions of use in food supplements for children aged 3 to less than 10 years and for adolescents aged 10 to less than 14 years of age (1).
CONTEXT: In the European Union, Astaxanthin-rich oleoresin from Haematococcus pluvialis algae is an authorized Novel Food for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the general population (2). The maximum authorised levels of the novel food is 40–80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day (3).
In 2021, the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae were amended (4): the use of the novel food in food supplements containing 40–80 mg of astaxanthin-rich oleoresin from Haematococcus pluvialis algae corresponding to levels of astaxanthin up to 8 mg has been limited to adults and adolescents above 14 years of age. The amendment was based on a safety opinion of the European Food Safety Authority (EFSA) related to the astaxanthin for its use as a novel food in food supplements (3). The EFSA opinion concluded on the safety of the levels up to 8 mg of astaxanthin only for the population above 14 years of age (3).
NOVEL FOOD APPLICATION: On 15 December 2022, The Natural Algae Astaxanthin Association (NAXA), the Association of manufacturers, growers, and marketers of natural algae astaxanthin derived from Haematococcus pluvialis, submitted an application for requesting the extension of conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’in food supplements to children 3 to less than 10 years of age and to adolescents aged 10 to less than 14 years of age.
Taking into account the Acceptable Daily Intake (ADI) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from the background diet as set out in the EFSA opinion published in 2020 (3), the applicant proposed maximum daily levels of astaxanthin-rich oleoresin from Haematococcus pluvialis algae in food supplements for children and adolescents which would result in overall intakes of astaxanthin that do not exceed the ADI.
OPINION OF THE EU COMMISSION: The EU Commission considered that the information provided in the application gives sufficient grounds to establish that the proposed changes in the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae are not liable to have an effect on human health and that a safety evaluation by the EFSA is not necessary. Consequently, the EU Commission considered that these changes should be approved.
REGULATION FOR AMENDING THE CONDITIONS OF USE: On 1 August 2023, the EU Commission published implementing Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’. The newly published Regulation provides maximum levels of astaxanthin according to the consumer targets:
- 2,3 mg astaxanthin per day for children 3 to less than 10 years of age;
- 5,7 mg astaxanthin per day for adolescents 10 to less than 14 years of age;
- 8 mg astaxanthin per day for general population older than 14 years of age.
The Regulation has also stated appropriate labelling requirements In line with the changes in the conditions of use depending on the targeted age groups of the consumer populations (1).
To know more on the Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’, click here.
(1): Commission Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae.
(2): COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
(3): EFSA Panel on Nutrition, Novel Foods and Food Allergens, Scientific Opinion on the safety of astaxanthin as a novel food in food supplements. EFSA Journal 2020;18(2):5993.
(4): Commission Implementing Regulation (EU) 2021/1377 of 19 August 2021 authorising the change of the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 297, 20.8.2021, p. 20).
Orchidali can contribute to preparing, writing and submitting a Novel Food application.
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Extension of conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ in the EU
On 1 August 2023, the EU Commission published implementing Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’. The new Regulation extends the conditions of use in food supplements for children aged 3 to less than 10 years and for adolescents aged 10 to less than 14 years of age (1).
CONTEXT: In the European Union, Astaxanthin-rich oleoresin from Haematococcus pluvialis algae is an authorized Novel Food for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council intended for the general population (2). The maximum authorised levels of the novel food is 40–80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day (3).
In 2021, the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae were amended (4): the use of the novel food in food supplements containing 40–80 mg of astaxanthin-rich oleoresin from Haematococcus pluvialis algae corresponding to levels of astaxanthin up to 8 mg has been limited to adults and adolescents above 14 years of age. The amendment was based on a safety opinion of the European Food Safety Authority (EFSA) related to the astaxanthin for its use as a novel food in food supplements (3). The EFSA opinion concluded on the safety of the levels up to 8 mg of astaxanthin only for the population above 14 years of age (3).
NOVEL FOOD APPLICATION: On 15 December 2022, The Natural Algae Astaxanthin Association (NAXA), the Association of manufacturers, growers, and marketers of natural algae astaxanthin derived from Haematococcus pluvialis, submitted an application for requesting the extension of conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’in food supplements to children 3 to less than 10 years of age and to adolescents aged 10 to less than 14 years of age.
Taking into account the Acceptable Daily Intake (ADI) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from the background diet as set out in the EFSA opinion published in 2020 (3), the applicant proposed maximum daily levels of astaxanthin-rich oleoresin from Haematococcus pluvialis algae in food supplements for children and adolescents which would result in overall intakes of astaxanthin that do not exceed the ADI.
OPINION OF THE EU COMMISSION: The EU Commission considered that the information provided in the application gives sufficient grounds to establish that the proposed changes in the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae are not liable to have an effect on human health and that a safety evaluation by the EFSA is not necessary. Consequently, the EU Commission considered that these changes should be approved.
REGULATION FOR AMENDING THE CONDITIONS OF USE: On 1 August 2023, the EU Commission published implementing Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’. The newly published Regulation provides maximum levels of astaxanthin according to the consumer targets:
The Regulation has also stated appropriate labelling requirements In line with the changes in the conditions of use depending on the targeted age groups of the consumer populations (1).
To know more on the Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’, click here.
(1): Commission Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae.
(2): COMMISSION IMPLEMENTING REGULATION (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods.
(3): EFSA Panel on Nutrition, Novel Foods and Food Allergens, Scientific Opinion on the safety of astaxanthin as a novel food in food supplements. EFSA Journal 2020;18(2):5993.
(4): Commission Implementing Regulation (EU) 2021/1377 of 19 August 2021 authorising the change of the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 297, 20.8.2021, p. 20).
Orchidali can contribute to preparing, writing and submitting a Novel Food application.
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