Commission Implementing Regulation (EU) 2025/1263of 30 June 2025authorising the placing on the market of roasted seeds of Dipteryx alata Vogel (baru) as a traditional food from a third country and amending Implementing Regulation (EU) 2017/2470(Text with EEA relevance)

Commission Implementing Regulation (EU) 2025/1263 of 30 June 2025 authorising the placing on the market of roasted seeds of Dipteryx alata Vogel (baru) as a traditional food from a third country 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 OJ L 327, 11.12.2015, p. 1, ELI: http://data.europa.eu/eli/reg/2015/2283/oj. , 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 of novel foods 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 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). has established a Union list of novel foods. (3) On 16 March 2023, the cooperative CoopCerrado – Cooperativa Mista de Agricultores Familiares, Extrativistas, Pescadores, Vazanteiros, Assentados e Indígenas do Cerrado (the applicant), formerly known as CoopCerrado –Cooperativa Mista de Agricultores Familiares, Extrativistas, Pescadores, Vazanteiros, Assentados e Guias turisticos do Cerrado submitted a notification to the Commission of their intention to place roasted seeds of Dipteryx alata Vogel (baru) 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 food concerned be used as a whole food (roasted seeds) by the general population. (4) The notification complies with the requirements laid down in Article 14 of Regulation (EU) 2015/2283. In particular, the data presented by the applicant demonstrate that roasted seeds of Dipteryx alata Vogel (baru) have a history of safe food use in Brazil. (5) Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 14 September 2023, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (the Authority). (6) No duly reasoned safety objections to the placing on the market within the Union of the food concerned were submitted to the Commission by the Member States or the Authority within the period set in Article 15(2) of Regulation (EU) 2015/2283.

(7) On 7 February 2025, the Authority published its Technical Report on the notification of roasted seeds of Dipteryx alata Vogel (baru) as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283 EFSA Supporting publication 2025:EN-9234 https://doi.org/10.2903/sp.efsa.2025.EN-9234. . In that report, the Authority concluded that the available data on the composition and the history of the requested use of roasted seeds of Dipteryx alata Vogel (baru) do not raise safety concerns. (8) The Commission should therefore authorise the placing on the market within the Union of roasted seeds of Dipteryx alata Vogel (baru) as a traditional food from a third country and update the Union list of novel foods accordingly. (9) Roasted seeds of Dipteryx alata Vogel (baru) 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. Roasted seeds of Dipteryx alata Vogel (baru) are authorised to be placed on the market within the Union. Roasted seeds of Dipteryx alata Vogel (baru) 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, 30 June 2025. For the Commission The President Ursula von der Leyen

Annex

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: Authorised novel foodConditions under which the novel food may be usedAdditional specific labelling requirementsOther requirementsData protectionRoasted seeds of Dipteryx alata Vogel (baru) (traditional food from a third country)Specified food categoryMaximum levelsThe designation of the novel food on the labelling of the foodstuffs containing it shall be roasted nuts of Dipteryx alata or roasted baru (Dipteryx alata) nuts.Not specified (2) in Table 2 (Specifications), the following entry is inserted: Authorised Novel FoodSpecificationRoasted seeds of Dipteryx alata Vogel (baru) (traditional food from a third country) Description/Definition: The traditional food consists of whole roasted nuts (seeds) of Dipteryx alata Vogel [Family: Fabaceae (alt. Leguminosae)]. Synonyms: Coumarouna alata (Vogel) Taub. Common names: Baru, bajuró, cumaru, cumarurana, and feijão-coco. Typical composition range: Water activity: ≤ 0,5 Moisture (g/100 g): ≤ 5 Protein (g/100 g): 20-35 Ash (g/100 g): ≤ 3,5 Total carbohydrates (g/100 g): 40-50

Fat (g/100 g): 20-35 Heavy metals: Lead: ≤ 0,1 mg/kg Arsenic: ≤ 0,1 mg/kg Cadmium: ≤ 0,2 mg/kg Process contaminants: Acrylamide: ≤ 300 μg/kg Mycotoxins: Sum of Aflatoxins (B1+B2+G1+G2): < 4 μg/kg Aflatoxin B1: < 2 μg/kg Microbiological criteria: Total aerobic mesophilic count: ≤ 5000 cfu/g Yeast & Moulds: ≤ 100 cfu/g E. coli: ≤ 10 cfu/g Salmonella: Not detected in 25 g Coliforms: ≤ 100 cfu/g Enterobacteriaceae: ≤ 1000 cfu/g Bacillus cereus: ≤ 100 cfu/g Staphylococcus aureus: ≤ 100 cfu/g Spores of sulphite-reducing clostridia: ≤ 100 cfu/g cfu: colony forming units