Novel food: astaxanthin-rich oleoresin from algae

Commission Implementing Regulation (EU) 2024/1026 of 8 April 2024 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae

Update

The European Commission has approved a change in the specifications of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae.

What is changing?

This Regulation authorises lower minimum specification limits for protein and astaxanthin (ATX) monoesters, and increased maximum specification limits for relative amounts of ATX diesters and 9-cis stereoisomers in total ATX (see Table 1).

Why?

EFSA (2023) concluded that the proposed changes in the specifications are safe at the acceptable daily intake (ADI) of ATX from food supplements at 0.2 mg/kg body weight.

Timeline

The new specifications apply from 29 April 2024.

Recommended Actions

Exporters of food supplements containing this substance must ensure that the new specifications set out in Table 1 are respected.

Background

Astaxanthin is a carotenoid produced from H. pluvialis algae, first authorised for use in food supplements for the general population by Regulation (EU) 2017/2470.

Implementing Regulation 2021/1377 limited its conditions of use to adults and adolescents older than 14 years based on an opinion of EFSA (2020).

Implementing Regulation (EU) 2023/1581 authorised its use in food supplements intended for children 3–10 years old and adolescents 10–14 years old, provided that the intake of ATX from food supplements would not exceed an ADI of 0.2 mg/kg body weight per day.

For further information on the novel food authorisation process, see Novel foods explained.

Resources

Sources

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Regulation

Regulation 2024/1026 as regards the specifications of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae

What is changing and why?

The European Commission approved a change in the specifications of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae. Food supplements containing astaxanthin (ATX), a carotenoid, are authorised for adults, for children 3–10 years old, and adolescents 10–14 years old. The European Food Safety Authority (EFSA) concluded that its use is safe as long as the intake of ATX does not exceed the Acceptable Daily Intake (ADI) of 0.2 mg/kg body weight per day. This Regulation authorises lower minimum limits for protein and ATX monoesters, and increased maximum limits for ATX diesters and the 9-cis stereoisomer in total ATX (see Table 1).

Actions

Exporters of food supplements containing this substance must ensure that the new specifications set out in Table 1 are respected.

Timeline

The new specifications apply from 29 April 2024.

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