Commission Implementing Regulation (EU) 2024/2101 of 30 July 2024 authorising the placing on the market of Schizochytrium sp. (CABIO-A-2) oil as a novel food and amending Implementing Regulation (EU) 2017/2470

• CELEX: Implementing Regulation (EU) 2024/2101
• Articles: 3

Article 1

(1)    Schizochytrium sp. (CABIO-A-2) oil is authorised to be placed on the market within the Union.

Schizochytrium sp. (CABIO-A-2) oil shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.

(2)   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 2

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

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

‘

Schizochytrium sp. (CABIO-A-2) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be “Oil from the microalgae Schizochytrium sp.”.’

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

‘

Schizochytrium sp. (CABIO-A-2) oil

Description/Definition:

The novel food is an oil produced from the strain CABIO-A-2 of the microalgae Schizochytrium sp.

Composition:

DHA content: ≥ 35,0 %

Acid value: ≤ 0,5 mg KOH/g

Peroxide value: ≤ 5,0 meq/kg

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 3,5 %

Trans-fatty acids: ≤ 2,0 %

Free fatty acids: ≤ 0,4 %

p -Anisidine value: ≤ 10’