Date: 2023-12-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2852 of 20 December 2023 correcting Implementing Regulation (EU) 2023/1581 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2852 corrects Implementing Regulation (EU) 2023/1581 regarding the conditions of use of astaxanthin-rich oleoresin from Haematococcus pluvialis algae. This correction addresses an error in the transitional measures, providing clarity and legal certainty to food business operators. The regulation is effective retroactively from August 21, 2023, and enters into force the day after its publication.
Key Points / Main Content:
* **Correction of Transitional Measures:**
* Article 2 of Implementing Regulation (EU) 2023/1581 is replaced.
* Food supplements containing 8.0 mg astaxanthin for the general population older than 14 years, complying with Implementing Regulation (EU) 2021/1377, can be placed on the market until February 1, 2024.
* These supplements may be marketed until their date of minimum durability or use-by date.
* **Legal Basis:**
* Based on Regulation (EU) 2015/2283 on novel foods, specifically Article 12.
* Corrects an error related to transitional measures for products compliant with Implementing Regulation (EU) 2021/1377 before Regulation (EU) 2023/1581.
* **Entry into Force and Application:**
* Enters into force the day following its publication in the Official Journal of the European Union.
* Applies retroactively from August 21, 2023.
Impact Analysis:
**Food Business Operators:**
* Impact: Provides clarity and legal certainty regarding the marketing of astaxanthin-rich oleoresin food supplements, especially those compliant with previous regulations.
* Action Required: Ensure compliance with the corrected transitional measures, specifically regarding the deadlines for placing products on the market and marketing them.
**Member States Competent Authorities:**
* Impact: Ensures clarity and legal certainty in enforcing regulations related to astaxanthin-rich oleoresin food supplements.
* Action Required: Implement and enforce the corrected transitional measures from August 21, 2023, and ensure compliance with the specified deadlines.
**General Population (Consumers):**
* Impact: Ensures the continued availability of food supplements containing astaxanthin that meet the previous regulatory standards during the transitional period, with appropriate labeling.
* Action Required: Be aware of the labeling requirements and recommended dosages of astaxanthin in food supplements.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EU 2015/2283: Regulation of the European Parliament and of the Council on novel foods.
Implementing Regulation EU 2017/2470: Commission Implementing Regulation establishing the Union list of novel foods.
Haematococcus pluvialis algae: A species of freshwater microalgae that is a source of astaxanthin.
Implementing Regulation EU 2023/1581: Commission Implementing Regulation amending Implementing Regulation EU 2017/2470 as regards the conditions of use of the novel food astaxanthin-rich oleoresin from Haematococcus pluvialis algae.
Directive 2002/46/EC: Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements
Brussels: The de facto capital city of the European Union, located in Belgium.
Official Journal EN
of the European Union L series
2023/2852 21.12.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2852
of 20 December 2023
correcting Implementing Regulation (EU) 2023/1581 amending Implementing Regulation
(EU) 2017/2470 as regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from
Haematococcus pluvialis algae’
(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 ‘astaxanthin-rich
oleoresin from Haematococcus pluvialis algae’ as an authorised novel food.
(4) The novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ has been authorised in accordance with
Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council(3) for use in food
supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council(4)intended for the
general population.
(5) Commission Implementing Regulation (EU) 2023/1581(5)has laid down additional labelling requirements in order
to prevent concomitant consumption of food supplements containing ≤ 8,0 mg of astaxanthin.
(6) The Commission has identified an error in Implementing Regulation (EU) 2023/1581 with regard to the transitional
measures. A transitional period in Implementing Regulation (EU) 2023/1581 for products complying with the
requirements of Commission Implementing Regulation (EU) 2021/1377(6) before the date of entry into force of
Regulation (EU) 2023/1581 was erroneously drafted. A correction is needed in order to provide clarity and legal
certainty to food business operators and to the Member States’ competent authorities, thus providing for the
marketing of those novel foods complying with the previous labelling requirements. In order to avoid uncertainty
about negative consequences for the concerned food business operators, this correction should enter into force
immediately and be applicable retroactively, from the entry into force of the Regulation (EU) 2023/1581.
(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) 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).
(4) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the
Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).
(5) Commission Implementing Regulation (EU) 2023/1581 of 1 August 2023 amending Implementing Regulation (EU) 2017/2470 as
regards the conditions of use of the novel food ‘astaxanthin-rich oleoresin from Haematococcus pluvialis algae’ (OJ L 194, 2.8.2023,
p. 4).
(6) 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 (OJ L 297, 20.8.2021, p. 20).
ELI: http://data.europa.eu/eli/reg_impl/2023/2852/oj 1/2EN
OJ L, 21.12.2023
(7) Implementing Regulation (EU) 2023/1518 should therefore be corrected accordingly.
(8) 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
Article 2 of Implementing Regulation (EU) 2023/1581 is replaced by the following:
‘Article 2
Food supplements containing ≤ 8,0 mg astaxanthin intended for the general population older than 14 years of age,
complying with the requirements of Implementing Regulation (EU) 2021/1377 may continue to be placed on the market
until 1 February 2024and may be marketed until their date of minimum durability or use by date.’
Article 2
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
It shall apply from 21 August 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 December 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_impl/2023/2852/oj