Date: 2023-12-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/2847 of 20 December 2023 authorising the placing on the market of apple fruit cell culture biomass as a novel food and amending Implementing Regulation (EU) 2017/2470
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2023/2847 authorises the placing on the market of apple fruit cell culture biomass as a novel food. The regulation amends Implementing Regulation (EU) 2017/2470 to include apple fruit cell culture biomass in the Union list of novel foods. It specifies conditions of use and labelling requirements, and it entered into force on the twentieth day following its publication in the Official Journal of the European Union on December 21, 2023.
Key Points / Main Content:
* **Authorisation:** Apple fruit cell culture biomass is authorised for placement on the market within the Union.
* **Inclusion in Union List:** Apple fruit cell culture biomass is included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
* **Amendment to Implementing Regulation (EU) 2017/2470:** The Annex to Implementing Regulation (EU) 2017/2470 is amended to include details of apple fruit cell culture biomass.
* **Conditions of Use:**
* Apple fruit cell culture biomass is authorised for use in food supplements as defined in Directive 2002/46/EC for the adult population.
* The maximum level is 0.15 mg/day.
* **Labelling Requirements:**
* The designation of the novel food on the labelling must be "apple fruit cell culture biomass".
* Food supplements containing the novel food must bear a statement that they should only be consumed by persons above 18 years of age.
* **Specification:**
* The novel food is a biomass of cultivated and homogenised cells of the Swiss apple variety Uttwiler Sptlauber Malus domestica Borkh.
Impact Analysis:
* **Food Supplement Manufacturers:**
* Impact: Can now use apple fruit cell culture biomass in food supplements, but must adhere to specific usage levels and labelling requirements.
* Action Required: Reformulate products to include apple fruit cell culture biomass at the specified levels, update labels to comply with naming and age restriction requirements.
* **Consumers (Adult Population):**
* Impact: Have access to food supplements containing apple fruit cell culture biomass.
* Action Required: Be aware of the age restriction (above 18 years) when considering the use of food supplements containing this novel food.
* **European Food Safety Authority (EFSA):**
* Impact: Their scientific opinion served as the basis for the authorisation.
* Action Required: No further action specified in this document.
* **European Commission:**
* Impact: Responsible for implementing and enforcing the regulation.
* Action Required: Ensure the regulation is applied and monitored across Member States.
* **Member States:**
* Impact: Must ensure the regulation is implemented and enforced within their jurisdictions.
* Action Required: Incorporate the changes into national legislation and monitor compliance.
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 budget.
Regulation (EU) 2015/2283: Regulation of the European Parliament and of the Council on novel foods.
Commission Implementing Regulation (EU) 2017/2470: Commission Implementing Regulation establishing the Union list of novel foods.
Apple fruit cell culture biomass: A novel food derived from cultivated cells of the Swiss apple variety Uttwiler Spätlauber (Malus domestica Borkh.).
European Food Safety Authority (EFSA): The agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
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.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2023/2847 21.12.2023
COMMISSION IMPLEMENTING REGULATION (EU) 2023/2847
of 20 December 2023
authorising the placing on the market of apple fruit cell culture biomass as a novel food and
amending Implementing Regulation (EU) 2017/2470
(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(1) 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) On 14 April 2020, the company Mibelle Group Biochemistry (‘the applicant’) submitted an application for an
authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place apple
fruit cell culture biomass on the Union market as a novel food. The applicant requested for apple fruit cell culture
biomass to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the
Council(3).
(4) On 2 December 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out
an assessment of apple fruit cell culture biomass as a novel food.
(5) On 24 May 2023, the Authority adopted its scientific opinion on the ‘Safety of apple fruit cell culture biomass as a
novel food pursuant to Regulation (EU) 2015/2283’(4) in accordance with Article 11 of Regulation
(EU) 2015/2283.
(6) In its scientific opinion, the Authority concluded that the novel food apple fruit cell culture biomass, is safe under the
proposed conditions of use, in food supplements for the adult population at maximum levels of 0,15 mg/day.
Therefore, that scientific opinion gives sufficient grounds to establish that apple fruit cell culture biomass, when
used under the proposed conditions of use fulfils the conditions for its placing on the market in accordance with
Article 12(1) of Regulation (EU) 2015/2283.
(7) It is appropriate that the inclusion of apple fruit cell culture biomass as a novel food in the Union list of novel foods
contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283. In this regard, in line with the
conditions of use of food supplements containing apple fruit cell culture biomass as proposed by the applicant and
assessed by the Authority, it is necessary to inform consumers by appropriate labelling that food supplements
containing apple fruit cell culture biomass is intended for the adult population.
(1) OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj.
(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, ELI:
http://data.europa.eu/eli/reg_impl/2017/2470/oj).
(3) 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, ELI: http://data.europa.eu/eli/dir/2002/46/oj).
(4) EFSA Journal 2023;21(7):8065
ELI: http://data.europa.eu/eli/reg_impl/2023/2847/oj 1/4EN
OJ L, 21.12.2023
(8) Apple fruit cell culture biomass should be included in the Union list of novel foods set out in Implementing
Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended
accordingly.
(9) 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
1. Apple fruit cell culture biomass is authorised to be placed on the market within the Union.
Apple fruit cell culture biomass 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.
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
2/4 ELI: http://data.europa.eu/eli/reg_impl/2023/2847/ojELI:
http://data.europa.eu/eli/reg_impl/2023/2847/oj
3/4
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:
Other
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Data protection
requirements
“Apple fruit cell Specified food category Maximum levels
culture biomass
Food supplements as defined in Directive 0,15 mg/day 1. The designation of the novel food on the
2002/46/EC for the adult population labelling of the foodstuffs containing it
shall be ‘apple fruit cell culture biomass’.
2. The labelling of food supplements con
taining the novel food shall bear a state
ment that they should only be consumed
by persons above 18 years of age.”
(2) in Table 2 (Specifications), the following entry is inserted:
Authorised Novel Food Specification
“Apple fruit cell culture biomass Description/Definition:
The novel food is a biomass of cultivated and homogenised cells of the Swiss apple variety Uttwiler Spätlauber (Malus domestica Borkh.).
The production process consists of collecting under sterile conditions specific sections of the apple, which are then placed on solid
medium with the aim to induce the formation of a primary callus tissue comprised of dedifferentiated cells under sterile conditions. The
callus cells are then cultivated in liquid medium and subsequently homogenised, heat treated and dried.
Characteristics/composition:
Moisture: 10,9–15,5 g/100 g
Ash: 11,8–20,8 g/100 g
Proteins: 14,3–20,0 g/100 g
Fats: 0,6–2,5 g/100 g
Non-digestible carbohydrates: 17,1–25,2 g/100 g
Other carbohydrates (calculated(*)): 21,9–38,9 g/100 g
Total sugars: 17,1–32,6 g/100g
Fructose: 10,8–20,2 g/100 g
Glucose: 3,8–7,0 g/100 g
OJ
L,
21.12.2023
EN4/4
ELI:
http://data.europa.eu/eli/reg_impl/2023/2847/oj
Total phenols: 0,15–0,29 g/100 g
Malic acid: 0,41–1,19 g/100 g
Succinic acid: 0,14–0,26 g/100 g
(*) Other carbohydrates (g/100g) = 100 (Dry residue) – Ash – Protein (Nitrogen × 6,25) – Total fat – Succinic acid – L-malic acid – Dietary fibre”
EN
OJ
L,
21.12.2023