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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)

Type Implementing Regulation

Publication 2023-03-21

State In force

Text As published

Department European Commission, SANTE

Source EUR-Lex

articles 2

This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.

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21.3.2023	EN	Official Journal of the European Union	L 81/23

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.

(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

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.

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

OJ L 327, 11.12.2015, p. 1.

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).

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).

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	Conditions under which the novel food may be used	Additional specific labelling requirements	Other requirements
‘*Roasted and popped kernels from the seeds of Euryale ferox* Salisb. (makhana) (Traditional food from a third country)**	Specified food category	Maximum levels	The designation of the novel food on the labelling of the foodstuffs containing it shall be “roasted seeds of Euryale ferox” or “makhana (Euryale ferox) roasted seeds”’
‘*Roasted and popped kernels from the seeds of Euryale ferox* Salisb. (makhana) (Traditional food from a third country)**	Processed nuts		The designation of the novel food on the labelling of the foodstuffs containing it shall be “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 ferox* Salisb. (makhana) (Traditional food from a third country)**	Description/Definition The traditional food consists of the roasted and popped kernels of the seeds of the fresh plants of Euryale ferox Salisb. (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 Tin: ≤ 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.’

Authorised Novel Food

Specifications

‘Roasted and popped kernels from the seeds of Euryale ferox Salisb. (makhana) (Traditional food from a third country)

Description/Definition The traditional food consists of the roasted and popped kernels of the seeds of the fresh plants of Euryale ferox Salisb. (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 Tin: ≤ 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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