Date: 2023-03-21Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2023/652 of 20 March 2023 authorising the placing on the market of roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2023/652 authorises the placing on the market of roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) as a traditional food from India within the European Union. It amends Commission Implementing Regulation EU 2017/2470 to include makhana in the Union list of novel foods. The regulation came into force on the twentieth day following its publication in the Official Journal of the European Union on 21 March 2023.
Key Points / Main Content:
* **Authorisation:** Roasted and popped makhana kernels are authorised to be placed on the market within the Union as a traditional food from a third country.
* **Union List Update:** The kernels are added to the Union list of novel foods set out in Implementing Regulation EU 2017/2470.
* **Amendment to Implementing Regulation EU 2017/2470:**
* Table 1 (Authorised novel foods) is amended to include roasted and popped makhana kernels. The designation on food labels must be "roasted seeds of Euryale ferox" or "makhana Euryale ferox roasted seeds."
* Table 2 (Specifications) is amended to include specifications for the kernels, including description, typical nutritional components, microbiological criteria, heavy metals, mycotoxins, pesticides and process contaminants.
* **Specifications for Makhana:**
* Description: Roasted and popped kernels of Euryale ferox Salisb. to be consumed as a snack.
* Production: The traditional food is produced via a series of steps involving the collection, washing, and drying of the seeds, a first roasting in oil, tempering at ambient temperatures, a subsequent second roasting in oil to pop the kernels, followed by hitting of the hot seeds to release the popped kernels.
* Also known as makhana or fox nuts.
* Nutritional information, microbiological criteria, heavy metals, mycotoxins, pesticides and process contaminants limits are detailed.
* **Entry into Force:** The regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
**Stakeholder: Food Producers/Companies (e.g., Zenko Superfoods Pte. Ltd)**
* Impact: Can now legally place roasted and popped makhana kernels on the EU market as a snack, provided they comply with the specifications outlined in the regulation.
* Action Required: Ensure products meet the required specifications for composition, contaminants, and labelling, as detailed in the Annex.
**Stakeholder: EU Member States**
* Impact: Must allow the placing on the market of roasted and popped makhana kernels that comply with the regulation.
* Action Required: Enforce the regulation and ensure that products on the market meet the specified requirements.
**Stakeholder: European Food Safety Authority (EFSA)**
* Impact: No direct impact, as EFSA has already provided its technical report.
* Action Required: No specific action required unless further safety concerns arise.
**Stakeholder: Consumers**
* Impact: Access to roasted and popped makhana kernels as a novel food option in the EU market.
* Action Required: No specific action required.
Key Entities Referenced
European Union: The political and economic union of European countries where the roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana are authorized to be placed on the market.
Commission Implementing Regulation EU 2023/652: Commission Implementing Regulation authorising the placing on the market of roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana.
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.
Euryale ferox Salisb. makhana: Roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana, a traditional food from India, authorized to be placed on the market within the Union.
Zenko Superfoods Pte. Ltd: The applicant company that submitted the notification to the Commission to place roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana on the Union market.
India: The third country where roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana have a history of safe food use.
European Food Safety Authority: The Authority that published its Technical Report on the notification of roasted and popped kernels from the seeds of Euryale ferox Salisb. makhana.
21.3.2023 EN Official Journal of the European Union L 81/23
COMMISSION IMPLEMENTING REGULATION (EU) 2023/652
of 20 March 2023
authorising the placing on the market of roasted and popped kernels from the seeds of Euryale ferox
Salisb. (makhana) as a traditional food from a third country under Regulation (EU) 2015/2283 of the
European Parliament and of the Council and amending Commission 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 and Commission Regulation (EC) No 1852/2001(1), and in particular Article 15(4) thereof,
Whereas:
(1) Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed
on the market within the Union. On the basis of the definition set out in Article 3(2)(c) of Regulation
(EU) 2015/2283, traditional food from a third country is considered a novel food.
(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 8 October 2021, the company Zenko Superfoods Pte. Ltd (‘the applicant’) submitted a notification to the
Commission of their intention to place roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana)
on the Union market as a traditional food from a third country in accordance with Article 14 of Regulation
(EU) 2015/2283. The applicant requested that the roasted and popped kernels from the seeds of Euryale ferox Salisb.
(makhana) be used as such as snacks by the general population.
(4) Pursuant to Article 7(3) of Commission Implementing Regulation (EU) 2017/2468(3), the Commission requested
additional information from the applicant as regards the requirements for validity of the notification. The requested
information was submitted on 9 February 2022.
(5) The notification complies with the requirements laid down in Article 14 of Regulation (EU) 2015/2283. The data
presented by the applicant demonstrate that roasted and popped kernels from the seeds of Euryale ferox Salisb.
(makhana) consumed as such as snacks have a history of safe food use in India.
(6) Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 22 March 2022, the Commission forwarded the valid
notification to the Member States and to the European Food Safety Authority (‘the Authority’).
(7) No duly reasoned safety objections to the placing on the market within the Union of roasted and popped kernels
from the seeds of Euryale ferox Salisb. (makhana) were submitted to the Commission by the Member States or the
Authority within the four-month period laid down in Article 15(2) of Regulation (EU) 2015/2283.
(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 Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements
concerning traditional foods from third countries 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. 55).L 81/24 EN Official Journal of the European Union 21.3.2023
(8) On 5 September 2022, the Authority published its ‘Technical Report on the notification of roasted and popped
kernels from the seeds of Euryale ferox Salisb. (makhana) as a traditional food from a third country pursuant to
Article 14 of Regulation (EU) 2015/2283’(4). The Authority concluded that the available data on the composition
and the history of use of the roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) do not
raise safety concerns.
(9) The Commission should therefore authorise the placing on the market within the Union of roasted and popped
kernels from the seeds of Euryale ferox Salisb. (makhana) as such as a snack and update the Union list of authorised
novel foods accordingly.
(10) Roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) should be included as a traditional food
from a third country 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,
HAS ADOPTED THIS REGULATION:
Article 1
1. The roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) are authorised to be placed on the
market within the Union.
The roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) shall be included as a traditional food
from a third country 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 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(4) EFSA Journal 2022;19(9):EN-7538. https://doi.org/10.2903/sp.efsa.2022.EN-7538.ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1) the following entry is inserted in Table 1 (Authorised novel foods):
Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements
‘Roasted and popped kernels from the Specified food category Maximum levels The designation of the novel food on the
seeds of Euryale ferox Salisb. (makhana) labelling of the foodstuffs containing it shall be
Processed nuts
(Traditional food from a third country) “roasted seeds of Euryale ferox” or “makhana
(Euryale ferox) roasted seeds”’
(2) the following entry is inserted in Table 2 (Specifications):
Authorised Novel Food Specifications
‘Roasted and popped kernels from the seeds of Euryale Description/Definition
ferox Salisb. (makhana) (Traditional food from a third The traditional food consists of the roasted and popped kernels of the seeds of the fresh plants of Euryale ferox Salisb.
country) (family: Nymphaeaceae, commonly referred to also as prickly water lily) to be consumed as a snack. The traditional food is
produced via a series of steps involving the collection, washing, and drying of the seeds, a first roasting in oil, tempering at
ambient temperatures, a subsequent second roasting in oil to pop the kernels, followed by hitting of the hot seeds to release
the popped kernels. The traditional food is also known as makhana or fox nuts.
Typical nutritional components:
Fat: 13,0 g/100 g
Carbohydrates: 75,0 g/100 g
Fibre: 2,5 g/100 g
Protein: 7 g/100 g
Moisture (% w/w): < 5,0
Ash: < 0,5 g/100 g
Microbiological criteria:
Total plate count: < 103 CFU/g
Total yeast and mould count: < 100 CFU/g
Total Enterobacteriaceae: < 10 CFU/g
Salmonella spp.: Absence in 25 g
Listeria monocytogenes: Absence in 25 g
Heavy metals:
Selenium: ≤ 0,8 mg/kg
Copper: ≤ 30,0 mg/kg
Lead: ≤ 0,1 mg/kg
Arsenic: ≤ 0,1 mg/kg
Cadmium: ≤ 0,1 mg/kg
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81/25Tin: ≤ 3,5 mg/kg
Mercury: ≤ 0,025 mg/kg
Mycotoxins:
Aflatoxin B1: ≤ 2,0 μg/kg
Sum of aflatoxins B1, B2, G1, and G2: ≤ 4,0 μg/kg
Ochratoxin A: ≤ 1,0 μg/kg
Citrinin: ≤ 20,0 μg/kg
Cyanotoxins:
Microcystins: ≤ 0,0015 mg/kg
Pesticides:
Pesticides: ≤ 0,01 mg/kg
Process contaminants:
Acrylamide: ≤ 40,0 μg/kg
Sum of PAHs: ≤ 10,0 μg/kg
Sum of dioxin-like PCBs: ≤ 0,35 pg/g
3-MCPD: ≤ 20,0 μg/kg
Glycidyl fatty acid esters (expressed as glycidol): ≤ 500,0 μg/kg
Sum of 3-MCPD and 3-MCPD fatty acid esters: ≤ 750,0 μg/kg
CFU: Colony Forming Units; PAHs: Polycyclic Aromatic Hydrocarbons; PCBs: Polychlorinated Biphenyls; 3-MCPD:
3-MonoChloroPropane Diol.’
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