COMMISSION IMPLEMENTING REGULATION (EU) 2023/667

23.3.2023 | EN | Official Journal of the European Union | L 84/3 ---|---|---|--- * * * COMMISSION IMPLEMENTING REGULATION (EU) 2023/667 of 22 March 2023 authorising the placing on the market of Canarium indicum L. dried nuts 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 (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 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 (2) has established a Union list of novel foods. ---|--- (3) | On 26 March 2020, the company Kawanasi Sehat Dasacatur, PT (‘the applicant’) submitted a notification to the Commission in accordance with Article 14 of Regulation (EU) 2015/2283 of its intention to place dried nuts of Canarium indicum L. (‘Kenari’) on the Union market as a traditional food from a third country. The applicant requested that the food concerned be used as such or added as an ingredient in cereal and bakery products, confectionary, snacks and prepared dishes intended for 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 dried nuts of Canarium indicum L. have a history of safe food use in the Spice Islands region of Indonesia. ---|--- (5) | Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 13 June 2022, 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 11 November 2022, the Authority published its ‘Technical Report on the notification of dried nuts of Canarium indicum L. as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283’ (3). In that report, the Authority concluded that the available data on the composition and the history of the requested use of dried nuts of Canarium indicum L.do not raise safety concerns. ---|--- (8) | In its report, the Authority also noted on the basis of limited published evidence on food allergy related to nuts of Canarium indicum L., that allergic reactions may be expected after the consumption of nuts of Canarium indicum L. In particular, studies showed cross-reactivity of nuts of Canarium indicum L. to hazel, cashew and pistachio. It is important that information on the presence of foods that may cause allergic reactions is given in a clear manner to enable consumers to make informed choices which are safe for them. Therefore, it is appropriate that nuts of Canarium indicum L. made available to the consumers are appropriately labelled following the requirements of Article 9 of Regulation (EU) 2015/2283 and by virtue of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (4). ---|--- (9) | The Commission should therefore authorise the placing on the market within the Union of Canarium indicum L. dried nuts as a traditional food from a third country and update the Union list of novel foods accordingly. ---|--- (10) | Canarium indicum L. dried nuts 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) Canarium indicum L. dried nuts is authorised to be placed on the market within the Union. Canarium indicum L. dried nuts 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, 22 March 2023. For the Commission The President Ursula VON DER LEYEN * * * (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) EFSA Supporting publication 2022:EN-7640. (4) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18). * * * 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 food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements ---|---|---|--- ‘ Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Specified food category | Maximum levels (g/100 g) | | 1. | The designation of the traditional food on the labelling of the foodstuffs containing it shall be “dried kenari (Canarium indicum) nuts”. ---|--- 2. | The labelling of the foodstuffs containing dried nuts of Canarium indicum L. shall bear a statement that the nuts may cause allergic reactions to consumers with known allergies to hazel, cashew and pistachio. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredient, in close proximity to the name of the food.’ ---|--- Not specified | (2) | in Table 2 (Specifications), the following entry is inserted: | Authorised Novel Food | Specifications ---|--- ‘ Canarium indicum L. dried nuts (Kenari) (Traditional food from a third country) | Description/Definition: The traditional food is processed dried kenari nuts. The term “Kenari Nuts” refers to the kernels of ripe Kenari Fruit, scientifically known as Canarium indicum L. (or Canarium amboinense Hochr.; family: Burseraceae). Composition: | | Ash: ≤ 5 (g/100 g) ---|--- | Moisture: ≤ 6 (g/100 g) ---|--- | Protein: 12,8 – 14,4 g/100 g ---|--- | Carbohydrates: 11,0 – 16,4 g/100 g ---|--- | Fat: 59,3 – 66,3 g/100 g ---|--- | Dietary fibre: 4,4 – 9,8 g/100 g ---|--- Microbiological criteria: | Aerobic Plate Count: ≤ 5,0 × 103 CFU/g ---|--- | Coliforms: < 3 MPN/g ---|--- | E. coli: < 3 MPN/g ---|--- | Yeasts and moulds: < 10 CFU/g ---|--- | Salmonella: Absent in 25 g ---|--- | Staphylococcus aureus (absent/25 g) ---|--- | Listeria monocytogenes (absent/25 g) ---|--- | Aflatoxins ---|--- | Aflatoxins B1: ≤ 2 mcg/kg ---|--- | Aflatoxins (Sum of B1, B2, G1, G2): ≤ 4 mcg/kg ---|--- | Dioxins and dioxin like PCBs ---|--- | Sum of dioxins: ≤ 0,75 pg/g fat ---|--- | Sum of dioxins and dioxin-like PCBs: ≤ 1,5 pg/g fat ---|--- | Heavy metals ---|--- | Cadmium (Cd): ≤ 0,02 mg/kg ---|--- | Lead (Pb): ≤ 0,07 mg/kg ---|--- CFU: Colony Forming Units’ * * *