Novel food: astaxanthin-rich oleoresin from algae
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Astaxanthin-rich oleoresin from Haematococcus pluvialis algae approved for use in food supplements for children and adolescents
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’
Update
The European Commission has approved the use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae in food supplements intended for children 3–10 years old and adolescents 10–14 years old.
What is changing?
In 2017 the EU approved astaxanthin-rich oleoresin from Haematococcus pluvialis algae as a novel food, but limited to food supplements for adults and adolescents over 14 years old.
This Regulation now authorises its use in food supplements intended for children aged 3–10 years and adolescents aged 10–14 years, provided the maximum limits and labelling rules set out in Table 1 are respected.
Why?
An EFSA evaluation concluded that the extension of use to younger children will not have negative effects on the health of this age group (EFSA 2020). The proposed intake of astaxanthin from food supplements does not exceed the acceptable daily intake (ADI) of 0.2 mg/kg body weight.
Timeline
The use of this substance in food supplements for younger children is permitted from 22 August 2023.
Recommended Actions
Exporters of food supplements containing this substance must ensure that the maximum limits and labelling conditions set out in Table 1 are respected.
Background
Astaxanthin-rich oleoresin from H. pluvialis algae was first authorised for use in food supplements for the general population (Regulation (EU) 2017/2470). Based on an opinion of EFSA (2020), Regulation 2021/1377 limited its conditions of use to adults and adolescents older than 14 years. In December 2022 the Commission received an application for its use in food supplements intended for children aged 3 to less than 10 years, and for adolescents aged 10 to less than 14 years. The Commission has authorised such use, considering that the intake of astaxanthin from food supplements as proposed by the applicant would not exceed the ADI of 0.2 mg/kg body weight per day.
For further information on the novel food authorisation process, see Novel foods explained.
Resources
EFSA (2020) Safety of astaxanthin for its use as a novel food in food supplements. EFSA Journal, 18(2): 5993.
Implementing Regulation (EU) 2017/2470 establishing the list of novel foods
Implementing Regulation (EU) 2021/1377 authorising the change of the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae
Sources
Implementing Regulation (EU) 2023/1581
Tables & Figures
Source: Implementing Regulation (EU) 2023/1581, Annex
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