# L_2020367EN.01003901.xml

| 5.11.2020 | EN | Official Journal of the European Union | L 367/39 |
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5.11.2020

EN

Official Journal of the European Union

L 367/39

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1634

of 4 November 2020

authorising the placing on the market of sugars obtained from cocoa (Theobroma cacao L.) pulp as a novel food 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 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 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. |
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(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.

| (2) | Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted. |
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(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods was adopted.

| (3) | Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list. |
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(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

| (4) | Commission Implementing Regulation (EU) 2020/206 (3) authorised the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 and amended the Union list of authorised novel foods. |
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(4)

Commission Implementing Regulation (EU) 2020/206 (3) authorised the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 and amended the Union list of authorised novel foods.

| (5) | On 22 November 2019, the company Cabosse Naturals NV (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place sugars obtained from cocoa (Theobroma cacao L.) pulp on the Union market as a novel food. The applicant requested for sugars obtained from cocoa (Theobroma cacao L.) pulp to be used as an ingredient for the general population. |
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(5)

On 22 November 2019, the company Cabosse Naturals NV (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place sugars obtained from cocoa (Theobroma cacao L.) pulp on the Union market as a novel food. The applicant requested for sugars obtained from cocoa (Theobroma cacao L.) pulp to be used as an ingredient for the general population.

| (6) | The sugars are obtained via a drying process or a purification process which removes the excess moisture and the other components present in the concentrated pulp juice from Theobroma cacao L. |
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(6)

The sugars are obtained via a drying process or a purification process which removes the excess moisture and the other components present in the concentrated pulp juice from Theobroma cacao L.

| (7) | The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The sugars obtained from the concentrated pulp juice from Theobroma cacao L. via drying or purification are identical to the sugars naturally present in the cocoa (Theobroma cacao L.) pulp and consist mainly of glucose and fructose that have a long history of safe use in foods, thus their authorisation would not alter the safety considerations that supported the authorisation of concentrated pulp juice from Theobroma cacao L. as a traditional food. |
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(7)

The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary. The sugars obtained from the concentrated pulp juice from Theobroma cacao L. via drying or purification are identical to the sugars naturally present in the cocoa (Theobroma cacao L.) pulp and consist mainly of glucose and fructose that have a long history of safe use in foods, thus their authorisation would not alter the safety considerations that supported the authorisation of concentrated pulp juice from Theobroma cacao L. as a traditional food.

| (8) | The information provided in the application gives sufficient grounds to establish that the proposed uses and use levels of the novel food sugars obtained from cocoa (Theobroma cacao L.) pulp comply with Article 12 of Regulation (EU) 2015/2283. |
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(8)

The information provided in the application gives sufficient grounds to establish that the proposed uses and use levels of the novel food sugars obtained from cocoa (Theobroma cacao L.) pulp comply with Article 12 of Regulation (EU) 2015/2283.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

1.   Sugars obtained from cocoa (Theobroma cacao L.) pulp as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established by Implementing Regulation (EU) 2017/2470.

2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

Article 2

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 3

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, 4 November 2020.

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)  Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice, concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Implementing Regulation (EU) 2017/2470 (OJ L 43, 17.2.2020, p. 66).

3

Theobroma cacao

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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 in alphabetical order:








  Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
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| ‘Sugars obtained from cocoa (Theobroma cacao L.) pulp | Not specified | The designation of the novel food on the labelling of the foodstuffs containing it shall be “sugars obtained from cocoa (Theobroma cacao L.) pulp”, “Glucose obtained from cocoa (Theobroma cacao L.) pulp” or “Fructose obtained from cocoa (Theobroma cacao L.) pulp”, depending on the form used.’ | |

(1)

in Table 1 (Authorised novel foods), the following entry is inserted in alphabetical order:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘Sugars obtained from cocoa (Theobroma cacao L.) pulp

Not specified

The designation of the novel food on the labelling of the foodstuffs containing it shall be “sugars obtained from cocoa (Theobroma cacao L.) pulp”, “Glucose obtained from cocoa (Theobroma cacao L.) pulp” or “Fructose obtained from cocoa (Theobroma cacao L.) pulp”, depending on the form used.’

| (2) | in Table 2 (Specifications), the following entry is inserted in alphabetical order:






  Authorised Novel Food | Specifications |
| --- | --- | --- |
| ‘Sugars obtained from cocoa (Theobroma cacao L.) pulp | Description/Definition:

  Sugars are obtained from the concentrated cocoa pulp (Theobroma cacao L.) juice either via a drying process or via a purification process to produce high purity glucose or fructose.

  Sugars produced by a drying process

  Nutritional composition:
  Total sugars (g/100g): > 80
  Moisture (%): < 5
  Microbiological criteria:
  Total Plate Count (aerobic) (cfu/g): < 104

  Moulds and Yeasts (cfu/g): < 50
  Enterobacteriaceae (cfu/g): < 10

  Salmonella spp.: Absence in 25 g

  Alicyclobacillus: Absence in 50 g
  Thermo-acidophilic bacteria: Absence in 50 g

  Sugars produced by a purification process

  Nutritional composition of Glucose obtained from cocoa (Theobroma cacao L.) pulp:
  Glucose content (%): > 93
  Ash (%): < 0,2
  Moisture (%): < 1,0
  Nutritional composition of Fructose obtained from cocoa (Theobroma cacao L.) pulp:
  Fructose content (%): > 98
  Glucose content (%): < 0,5 %
  Ash (%): < 0,2
  Moisture (%):< 0,5
  Microbiological criteria for glucose and fructose obtained from cocoa (Theobroma cacao L.) pulp:
  Total Plate Count (aerobic) (cfu/g): < 104


  Salmonella spp.: Absence in 25 g’ |

(2)

in Table 2 (Specifications), the following entry is inserted in alphabetical order:

Authorised Novel Food

Specifications

‘Sugars obtained from cocoa (Theobroma cacao L.) pulp

Description/Definition:

Sugars are obtained from the concentrated cocoa pulp (Theobroma cacao L.) juice either via a drying process or via a purification process to produce high purity glucose or fructose.

Sugars produced by a drying process

Nutritional composition:

Total sugars (g/100g): > 80

Moisture (%): < 5

Microbiological criteria:

Total Plate Count (aerobic) (cfu/g): < 104

Moulds and Yeasts (cfu/g): < 50

Enterobacteriaceae (cfu/g): < 10

Salmonella spp.: Absence in 25 g

Alicyclobacillus: Absence in 50 g

Thermo-acidophilic bacteria: Absence in 50 g

Sugars produced by a purification process

Nutritional composition of Glucose obtained from cocoa (Theobroma cacao L.) pulp:

Glucose content (%): > 93

Ash (%): < 0,2

Moisture (%): < 1,0

Nutritional composition of Fructose obtained from cocoa (Theobroma cacao L.) pulp:

Fructose content (%): > 98

Glucose content (%): < 0,5 %

Ash (%): < 0,2

Moisture (%):< 0,5

Microbiological criteria for glucose and fructose obtained from cocoa (Theobroma cacao L.) pulp:

Total Plate Count (aerobic) (cfu/g): < 104

Salmonella spp.: Absence in 25 g’

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