# L_2023039EN.01000101.xml

| 9.2.2023 | EN | Official Journal of the European Union | L 39/1 |
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9.2.2023

EN

Official Journal of the European Union

L 39/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/267

of 8 February 2023

authorising the placing on the market of dried nuts of Canarium ovatum Engl. 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), point (c), of that Regulation, traditional food from a third country is considered a novel food. |
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(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), point (c), of that Regulation, 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. |
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(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 28 March 2019, the company DOMENICODELUCIA SPA (‘the applicant’) submitted a notification to the Commission of their intention to place nuts of Canarium ovatum Engl. 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 for dried nuts of Canarium ovatum Engl. to be consumed as such by the general population. |
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(3)

On 28 March 2019, the company DOMENICODELUCIA SPA (‘the applicant’) submitted a notification to the Commission of their intention to place nuts of Canarium ovatum Engl. 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 for dried nuts of Canarium ovatum Engl. to be consumed as such 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 dried nuts of Canarium ovatum Engl. have a history of safe food use in the Philippines. |
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(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 ovatum Engl. have a history of safe food use in the Philippines.

| (5) | Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 13 December 2021, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’). |
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(5)

Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 13 December 2021, 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. |
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(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 13 May 2022, the Authority published its Technical Report on the notification of nuts of Canarium ovatum Engl. as a traditional food from a third country (3). In that report, the Authority concluded that the available data on the composition and the history of the requested use of nuts of Canarium ovatum Engl. do not raise safety concerns. |
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(7)

On 13 May 2022, the Authority published its Technical Report on the notification of nuts of Canarium ovatum Engl. as a traditional food from a third country (3). In that report, the Authority concluded that the available data on the composition and the history of the requested use of nuts of Canarium ovatum Engl. do not raise safety concerns.

| (8) | The Commission should therefore authorise the placing on the market within the Union of dried nuts of Canarium ovatum Engl. as a traditional food from a third country and update the Union list of novel foods accordingly. |
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(8)

The Commission should therefore authorise the placing on the market within the Union of dried nuts of Canarium ovatum Engl. as a traditional food from a third country and update the Union list of novel foods accordingly.

| (9) | In its report, the Authority also noted on the basis of limited published evidence on food allergy related to nuts of Canarium ovatum Engl., that allergic reactions may be expected after the consumption of nuts of Canarium ovatum Engl. In particular, studies showed an in vitro cross-reactivity of nuts of Canarium ovatum Engl. to cashew and walnut. 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 ovatum Engl. made available to the consumers are appropriately labelled following the requirements of Article 9 of Regulation (EU) 2015/2283. |
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(9)

In its report, the Authority also noted on the basis of limited published evidence on food allergy related to nuts of Canarium ovatum Engl., that allergic reactions may be expected after the consumption of nuts of Canarium ovatum Engl. In particular, studies showed an in vitro cross-reactivity of nuts of Canarium ovatum Engl. to cashew and walnut. 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 ovatum Engl. made available to the consumers are appropriately labelled following the requirements of Article 9 of Regulation (EU) 2015/2283.

| (10) | Dried nuts of Canarium ovatum Engl. 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, |
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(10)

Dried nuts of Canarium ovatum Engl. 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.   Dried nuts of Canarium ovatum Engl. are authorised to be placed on the market within the Union.

Dried nuts of Canarium ovatum Engl. 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, 8 February 2023.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 327, 11.12.2015, p. 1.

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).

2

(3)  
  EFSA Supporting publication 2022:EN-7314.

3

EFSA Supporting publication

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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 |
| --- | --- | --- | --- | --- |
| ‘Dried nuts of Canarium ovatum Engl. | Specified food category | Maximum levels | 1. | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nuts of Canarium ovatum’ and/or ‘pilinuts’ and/or ‘pili (Canarium ovatum) nuts’. |

(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

‘Dried nuts of Canarium ovatum Engl.

Specified food category

Maximum levels

1.

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘nuts of Canarium ovatum’ and/or ‘pilinuts’ and/or ‘pili (Canarium ovatum) nuts’.

| 2. | The labelling of the foodstuffs containing dried nuts of Canarium ovatum Engl. shall bear a statement that the dried nuts of Canarium ovatum Engl. may cause allergic reactions to consumers with known allergies to cashew and walnut. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.’ |
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2.

The labelling of the foodstuffs containing dried nuts of Canarium ovatum Engl. shall bear a statement that the dried nuts of Canarium ovatum Engl. may cause allergic reactions to consumers with known allergies to cashew and walnut. This statement shall appear in close proximity to the list of ingredients or, in the absence of a list of ingredients, in close proximity to the name of the food.’

Not specified

| (2) | The following entry is inserted in Table 2 (Specifications):






  Authorised Novel Food | Specifications |
| --- | --- | --- |
| ‘Dried nuts of Canarium ovatum Engl. | Description/Definition:

  The traditional food consists of the unroasted dried nuts of Canarium ovatum Engl. (family: Burseraceae) commonly known as Pili nuts. Pili nuts are produced only by plants of Canarium ovatum Engl. varieties Laysa, Magnaye, M. Orolfo, Lanuza and Magayon and can be placed on the market with or without the shell. The edible part of the nut is the kernel.

  Typical composition range: | Fat: 57-73 % |

(2)

The following entry is inserted in Table 2 (Specifications):

Authorised Novel Food

Specifications

‘Dried nuts of Canarium ovatum Engl.

Description/Definition:

The traditional food consists of the unroasted dried nuts of Canarium ovatum Engl. (family: Burseraceae) commonly known as Pili nuts. Pili nuts are produced only by plants of Canarium ovatum Engl. varieties Laysa, Magnaye, M. Orolfo, Lanuza and Magayon and can be placed on the market with or without the shell. The edible part of the nut is the kernel.

Typical composition range:

Fat: 57-73 %

| | Protein: 11-15 % |
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Protein: 11-15 %

| | Water: 1-5 % |
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Water: 1-5 %

| | Carbohydrates: 8-16,5 % |
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Carbohydrates: 8-16,5 %

| | Ash: 2,8-3,4 % |
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Ash: 2,8-3,4 %

Microbiological criteria:

| | Moulds and yeasts: ≤ 100 CFU/g |
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Moulds and yeasts: ≤ 100 CFU/g

| | Total colony count at 30 °C: ≤ 10 000 CFU/g |
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Total colony count at 30 °C: ≤ 10 000 CFU/g

| | Coliforms: ≤ 100 CFU/g |
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Coliforms: ≤ 100 CFU/g

| | Escherichia coli: ≤ 10 CFU/g |
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Escherichia coli: ≤ 10 CFU/g

| | Staphylococcus aureus: Absence in 25 g |
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Staphylococcus aureus: Absence in 25 g

| | Salmonella spp.: Absence in 25 g |
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Salmonella spp.: Absence in 25 g

| | Listeria monocytogenes: Absence in 25 g |
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Listeria monocytogenes: Absence in 25 g

| | Sulphite reducing anaerobes: ≤ 10 CFU/g |
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Sulphite reducing anaerobes: ≤ 10 CFU/g

CFU: Colony Forming Units’

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