Commission Implementing Regulation (EU) 2022/966 of 21 June 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2022/966
• Articles: 4

Article 1

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

Article 2

1.    Calanus finmarchicus oil food supplements 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.    Calanus finmarchicus oil food supplements which were dispatched from a third country and were on their way to the Union before the date of entry into force of this Regulation and complying with the rules in force before the date of entry into force of this Regulation, may be marketed until their date of minimum durability or use by date.

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

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

(1)

in Table 1 (Authorised novel foods), the entry for ‘ Calanus finmarchicus oil’ is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘

Calanus finmarchicus oil

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘oil from Calanus finmarchicus (crustacean)’.

2.

The labelling of food supplements containing Calanus finmarchicus oil shall bear a statement that those food supplements should not be consumed:

a)

if other food supplements containing astaxanthin esters are consumed on the same day.

b)

by infants and children younger than 3 years.

c)

by children younger than 14 years, if the ingredient contains ≥ 0,1 % astaxanthin.’

Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

1,0 g/day (< 0,1 % astaxanthin esters, resulting in < 1,0 mg astaxanthin per day) for the general population, excluding infants and young children

2,3 g/day (from 0,1 % to ≤ 0,25 % astaxanthin esters, resulting in ≤ 5,75 mg astaxanthin per day) for the general population older than 14 years of age

(2)

in Table 2 (Specifications), the entry for ‘ Calanus finmarchicus oil’ is replaced by the following:

Authorised Novel Food

Specifications

‘

Calanus finmarchicus oil

Description/Definition:

The novel food is ruby coloured, slightly viscous oil with a slight shellfish odour extracted from the crustacean (marine zooplankton) Calanus finmarchicus . The ingredient consists primarily of wax esters (> 85 %) with minor amounts of triglycerides and other neutral lipids.

Specifications:

Water: < 1,0 %

Wax esters: > 85 %

Total fatty acids: > 46 %

Eicosapentaenoic acid (EPA): > 3,0 %

Docosahexaenoic acid (DHA): > 4,0 %

Total fatty alcohols: > 28 %

C20:1 n-9 fatty alcohol: > 9,0 %

C22:1 n-11 fatty alcohol: > 12 %

Trans fatty acids: < 1,0 %

Astaxanthin esters: ≤ 0,25 %

Peroxide value (PV): < 3,0 meq. O 2 /kg’