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 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/1377
• Articles: 4

Article 1

1.   The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae, is amended as specified in the Annex to this Regulation.

2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

1.   Food supplements containing ≤ 8,0 mg astaxanthin intended for the general population which were lawfully placed on the market before the date of entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

2.   Foods supplements containing ≤ 8,0 mg astaxanthin intended for the general population imported into the Union may be marketed until their date of minimum durability or use by date where the importer of such food can demonstrate that they were dispatched from the third country concerned and were on their way to the Union before the date of entry into force of this Regulation.

3.   The food business operators should provide a notice for the food supplements referred to in paragraph 1 to be displayed at the place of sale informing them that those food supplements should not be consumed by infants, children and adolescents below the age of 14 years.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

In the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ in Table 1 (Authorised novel foods) is replaced by the following:

‘ Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘Astaxanthin-rich oleoresin from Haematococcus pluvialis algae’

Specified food category

Maximum levels

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 by infants, children, and adolescents younger than 14 years.’

Food Supplements as defined in Directive 2002/46/EC, excluding infants, young children, children, and adolescents younger than14 years

40-80 mg/day of oleoresin, resulting in ≤ 8 mg astaxanthin per day