Date: 2022-06-22Category: Not ApplicableState: Union GovernmentCountry: Europe
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)
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2022/966 amends Implementing Regulation (EU) 2017/2470 regarding Calanus finmarchicus oil, a novel food. The changes concern the conditions of use, specific labeling requirements, and specifications, particularly regarding astaxanthin ester levels. The regulation includes transitional measures for products already on the market before the entry into force, which is the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content:**
* **Amendment Purpose:** Updates the Union list of novel foods concerning Calanus finmarchicus oil.
* **Specifications of Calanus finmarchicus oil:**
* Increase of astaxanthin esters level allowed up to 0.25% for persons older than 14 years.
* **Conditions of Use:**
* For general population food supplements with 0.1% astaxanthin esters:
* Reduced Calanus finmarchicus oil level from 2.3 g/day to 1.0 g/day.
* Exclusion of use by infants and young children.
* For population older than 14 years, level of astaxanthin esters can be increased from 0.1% to 0.25%.
* **Labelling Requirements:**
* Food supplements must be labelled to ensure use by the appropriate age group.
* Additional warning labels are required:
* Advise against concurrent consumption with other astaxanthin ester supplements.
* Restrictions for infants and children younger than 3 years.
* Restrictions for children younger than 14 years, if the ingredient contains 0,1 astaxanthin.
* **Transitional Measures:**
* Lawfully marketed food supplements before the regulation's entry into force can be sold until their minimum durability or use-by date.
* Products dispatched from third countries before the entry into force, complying with previous rules, can be marketed until their minimum durability or use-by date.
* **Annex Amendments to Implementing Regulation (EU) 2017/2470:**
* Table 1 (Authorised novel foods) is replaced with updated conditions of use and labelling requirements for Calanus finmarchicus oil.
* Table 2 (Specifications) is replaced with updated specifications for Calanus finmarchicus oil, including astaxanthin ester levels up to 0.25%.
**Impact Analysis:**
* **Calanus AS (Applicant):**
* *Impact:* Approved changes to specifications, conditions of use, and labelling requirements for their Calanus finmarchicus oil product.
* *Action Required:* Implement the new specifications and labelling requirements for Calanus finmarchicus oil food supplements and comply with the updated conditions of use.
* **Food Supplement Manufacturers:**
* *Impact:* Need to reformulate and relabel food supplements containing Calanus finmarchicus oil to comply with the new regulations.
* *Action Required:* Adjust product formulations, update labels, and ensure compliance with maximum levels, usage conditions, and labeling requirements.
* **Retailers/Distributors:**
* *Impact:* Must ensure that products on the market comply with the new regulations.
* *Action Required:* Remove non-compliant products and ensure only compliant products are sold.
* **Consumers:**
* *Impact:* Access to food supplements with adjusted astaxanthin ester levels and clearer labelling.
* *Action Required:* Read and follow the updated labeling instructions to ensure safe consumption, especially regarding age restrictions and concurrent consumption with other astaxanthin supplements.
* **Enforcement Authorities:**
* *Impact:* Responsible for monitoring and enforcing compliance with the updated regulations.
* *Action Required:* Monitor the market for compliance, conduct inspections, and take appropriate action against non-compliant products.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Calanus finmarchicus oil: A novel food derived from the marine zooplankton Calanus finmarchicus, subject to specific regulations regarding its use, specifications, and labeling.
Regulation EU 2015/2283: A European Union regulation concerning novel foods, which governs the authorization and placing on the market of novel foods within the Union.
Commission Implementing Regulation EU 2017/2470: A European Union regulation establishing the Union list of novel foods, including Calanus finmarchicus oil.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
Brussels: The de facto capital city of the European Union, located in Belgium, where the regulation was adopted.
Astaxanthin esters: A component of Calanus finmarchicus oil, subject to specific maximum levels and labeling requirements due to safety considerations.
22.6.2022 EN Official Journal of the European Union L 166/125
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)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on
novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing
Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC)
No 1852/2001(1), and in particular Article 12 thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods
may be placed on the market within the Union.
(2) Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470(2)has
established a Union list of novel foods.
(3) The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Calanus finmarchicus oil as
an authorised novel food.
(4) Commission Implementing Decision (EU) 2017/2353(3)authorised, in accordance with Regulation (EC) No 258/97
of the European Parliament and of the Council(4), the placing on the market of Calanus finmarchicus oil as a novel
food ingredient to be used in food supplements intended for the general population.
(5) On 30 November 2021, the company ‘Calanus A/S’ (‘the applicant’) submitted an application to the Commission in
accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications, of the conditions of
use, and of the specific labelling requirements of the novel food ‘Calanus finmarchicus oil’. The applicant proposed to
change the specifications of Calanus finmarchicus oil with regard to astaxanthin esters to the level up to 0,25 %. They
requested an increased maximum level of up to 0,25 % of astaxanthin esters contained in Calanus finmarchicus oil for
persons older than fourteen years of age, in addition to the currently authorised maximum level of < 0,1 % of
astaxanthin esters in Calanus finmarchicus oil for the general population. For food supplements containing the
currently authorised level of < 0,1 % astaxanthin esters that are intended for the general population, the applicant
proposed reducing the currently authorised use levels of the Calanus finmarchicus oil from 2,3 g/day to 1,0 g/day and
excluding infants and young children.
(6) As a consequence of the proposed changes in the specifications Calanus finmarchicus oil and the conditions of use of
this novel food, the applicant proposed an amendment in its labelling to ensure that consumers only use the food
supplements intended for their age group. In addition, in light of the current use of food supplements containing
astaxanthin esters in the Union market, the applicant also proposed additional specific labelling to warn consumers
not to use Calanus finmarchicus oil food supplements, when other food supplements containing astaxanthin esters
are consumed on the same day.
(1) OJ L 327, 11.12.2015, p. 1.
(2) Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance
with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).
(3) Commission Implementing Decision (EU) 2017/2353 of 14 December 2017 authorising the placing on the market of oil from Calanus
finmarchicus as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 336,
16.12.2017, p. 45).
(4) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food
ingredients (OJ L 43, 14.2.1997, p. 1).L 166/126 EN Official Journal of the European Union 22.6.2022
(7) The Commission considers that the requested update of the Union list concerning specifications of Calanus
finmarchicus oil and the resulting changes in its conditions of use for the population groups older than 14 years of
age is not liable to have an effect on human health and that a safety evaluation by the European Food Safety
Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The
increase in the astaxanthin esters in oil from Calanus finmarchicus from < 0,1 % to ≤ 0,25 % in food supplements
intended for population groups older than 14 years is expected to result in intakes of astaxanthin esters which, in
combination with the intake of astaxanthin from the normal diet, are not expected to exceed the revised Acceptable
Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg bw, established by the Authority(5).
(8) Furthermore, the Commission considers that the requested update of the Union list concerning the reduction of the
currently authorised use levels of Calanus finmarchicus oil from 2,3 g/day to 1,0 g/day in food supplements intended
for the general population that contain < 0,1 % astaxanthin esters, and the exclusion of infants and young children
is also not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with
Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The exclusion of infants and young children is justified
because the anticipated combined intake of astaxanthin esters from food supplements containing Calanus
finmarchicus oil with levels of < 0,1 % astaxanthin esters and from the normal diet is expected to exceed the revised
Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg of body weight established by the Authority for these
groups of consumers.
(9) The proposed change to the specifications and conditions of use of Calanus finmarchicus oil as regards the astaxanthin
esters values are in line with the conclusions of the safety assessment conducted by the Authority on astaxanthin.
Therefore, it is appropriate to amend the specifications and the conditions of use of the novel food Calanus
finmarchicus oil at the proposed astaxanthin esters levels.
(10) The proposed changes to the labelling requirements of Calanus finmarchicus oil are in line with the conclusions of the
safety assessment conducted by the Authority on astaxanthin. In addition, the Commission considers appropriate to
lay down additional labelling requirement in order to prevent concomitant consumption of astaxanthin food
supplements, which is likely to exceed the ADI established by the Authority. Therefore, it is appropriate to include
additional labelling requirements for that novel food.
(11) The information provided in the application gives sufficient grounds to establish that the changes to the conditions
of use, the specific labelling requirements and specifications of the novel food Calanus finmarchicus oil are in
accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
(12) The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.
(13) In order to provide business operators with sufficient time to adjust their practices to comply with the requirements
of this Regulation, transitional measures should be laid down as regards food supplements containing Calanus
finmarchicus oil, which have been lawfully placed on the Union market or dispatched from third countries for the
Union, before the date of entry into force of this Regulation.
(14) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
(5) Safety of astaxanthin for its use as a novel food in food supplements; EFSA Journal 2020;18(2):5993.22.6.2022 EN Official Journal of the European Union L 166/127
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 21 June 2022.
For the Commission
The President
Ursula VON DER LEYENANNEX
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 con
Food supplements as defined in 1,0 g/day (< 0,1 % astaxanthin esters,
taining it shall be ‘oil from Calanus
Directive 2002/46/EC, excluding food resulting in < 1,0 mg astaxanthin per day)
finmarchicus (crustacean)’.
supplements for infants and young for the general population, excluding
children infants and young children 2. The labelling of food supplements
containing Calanus finmarchicus oil
2,3 g/day (from 0,1 % to ≤ 0,25 % shall bear a statement that those food
astaxanthin esters, resulting in ≤ 5,75 mg supplements should not be con
astaxanthin per day) for the general sumed:
population older than 14 years of age 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 % astax
anthin.’
(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 %
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22.6.2022Docosahexaenoic 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 /kg’
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