# L_2020209EN.01001001.xml

| 2.7.2020 | EN | Official Journal of the European Union | L 209/10 |
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2.7.2020

EN

Official Journal of the European Union

L 209/10

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/917

of 1 July 2020

authorising the placing on the market of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner 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

(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 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. Traditional food from a third country is a novel food defined in Article 3(2)(c) of Regulation (EU) 2015/2283. |
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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. Traditional food from a third country is a novel food defined in Article 3(2)(c) of Regulation (EU) 2015/2283.

| (2) | Commission Implementing Regulation (EU) 2017/2468 (2) lays down administrative and scientific requirements concerning traditional foods from third countries. |
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(2)

Commission Implementing Regulation (EU) 2017/2468 (2) lays down administrative and scientific requirements concerning traditional foods from third countries.

| (3) | Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (3) establishing a Union list of authorised novel foods was adopted. |
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(3)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (3) establishing a Union list of authorised novel foods was adopted.

| (4) | Pursuant to Article 15(4) of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a traditional food from a third country. |
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(4)

Pursuant to Article 15(4) of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a traditional food from a third country.

| (5) | On 27 November 2018, the company AM Breweries (‘the applicant’) submitted a notification to the Commission of the intention to place infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner on the Union market as a traditional food from a third country in accordance with Article 14 of Regulation (EU) 2015/2283. The applicant requests for infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora to be used as such or as an ingredient in other beverages by the general population. |
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(5)

On 27 November 2018, the company AM Breweries (‘the applicant’) submitted a notification to the Commission of the intention to place infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner on the Union market as a traditional food from a third country in accordance with Article 14 of Regulation (EU) 2015/2283. The applicant requests for infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora to be used as such or as an ingredient in other beverages by the general population.

| (6) | Pursuant to Article 7(2) of Implementing Regulation (EU) 2017/2468, the Commission requested additional information from the applicant as regards the validity of the notification. The requested information was submitted on 4 June 2019, 21 June 2019, 29 August 2019 and 30 August 2019. |
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(6)

Pursuant to Article 7(2) of Implementing Regulation (EU) 2017/2468, the Commission requested additional information from the applicant as regards the validity of the notification. The requested information was submitted on 4 June 2019, 21 June 2019, 29 August 2019 and 30 August 2019.

| (7) | The data presented by the applicant demonstrate that infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such has a history of safe food use in Africa, Asia and North America. |
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(7)

The data presented by the applicant demonstrate that infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such has a history of safe food use in Africa, Asia and North America.

| (8) | Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 11 September 2019, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’). |
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(8)

Pursuant to Article 15(1) of Regulation (EU) 2015/2283, on 11 September 2019, the Commission forwarded the valid notification to the Member States and to the European Food Safety Authority (‘the Authority’).

| (9) | No duly reasoned safety objections to the placing on the market within the Union of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora were submitted to the Commission by the Member States or the Authority within the four-months period laid down in Article 15(2) of Regulation (EU) 2015/2283. |
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(9)

No duly reasoned safety objections to the placing on the market within the Union of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora were submitted to the Commission by the Member States or the Authority within the four-months period laid down in Article 15(2) of Regulation (EU) 2015/2283.

| (10) | On 3 February 2020, the Authority published its ‘Technical Report on the notification of infusion from coffee leaves (Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner) as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283’ (4). |
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(10)

On 3 February 2020, the Authority published its ‘Technical Report on the notification of infusion from coffee leaves (Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner) as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283’ (4).

| (11) | In that report, the Authority noted that the leaves of Coffea
  arabica contain Epigallocatechin gallate (EGCG) and therefore, the presence of EGCG in the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora cannot be excluded. On that basis, the Authority established a maximum level of 700 mg of EGCG per litre of the infusion. It is therefore appropriate to establish maximum levels of 700 mg/L of EGCG in the specifications of the traditional food in the Union list of authorised novel foods. |
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(11)

In that report, the Authority noted that the leaves of Coffea
  arabica contain Epigallocatechin gallate (EGCG) and therefore, the presence of EGCG in the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora cannot be excluded. On that basis, the Authority established a maximum level of 700 mg of EGCG per litre of the infusion. It is therefore appropriate to establish maximum levels of 700 mg/L of EGCG in the specifications of the traditional food in the Union list of authorised novel foods.

| (12) | The Authority concluded that the available data on composition and history of use of the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora do not raise safety concerns. |
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(12)

The Authority concluded that the available data on composition and history of use of the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora do not raise safety concerns.

| (13) | In addition to the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora to be used as such, the applicant requested the infusion to be used as an ingredient in other beverages for the general population. The applicant has submitted documented data demonstrating history of safe use in a third country in accordance with Article 14(1)(e) of Regulation (EU) 2015/2283 only for the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such, while no evidence on the use of the infusion as ingredient in other beverages was submitted. The applicant was invited to provide clarification, and possibly revision, of the proposed uses of the infusion, which correspond to the foods in which the infusion is traditionally consumed and for which a history of safe use should have been submitted. However, the applicant did not change the proposed uses and did not provide evidence demonstrating the history of safe food use in a third country of the infusion as ingredient in other beverages. Consequently, in the absence of the required documented data, the Commission is of view that the history of safe food use in a third country has been demonstrated by the applicant only for the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such. Therefore, the notification for the authorisation of the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora, as far as it concerns its use as an ingredient in other beverages, is considered not valid. |
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(13)

In addition to the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora to be used as such, the applicant requested the infusion to be used as an ingredient in other beverages for the general population. The applicant has submitted documented data demonstrating history of safe use in a third country in accordance with Article 14(1)(e) of Regulation (EU) 2015/2283 only for the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such, while no evidence on the use of the infusion as ingredient in other beverages was submitted. The applicant was invited to provide clarification, and possibly revision, of the proposed uses of the infusion, which correspond to the foods in which the infusion is traditionally consumed and for which a history of safe use should have been submitted. However, the applicant did not change the proposed uses and did not provide evidence demonstrating the history of safe food use in a third country of the infusion as ingredient in other beverages. Consequently, in the absence of the required documented data, the Commission is of view that the history of safe food use in a third country has been demonstrated by the applicant only for the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such. Therefore, the notification for the authorisation of the infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora, as far as it concerns its use as an ingredient in other beverages, is considered not valid.

| (14) | The Commission should therefore authorise the placing on the market within the Union of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such and update the Union list of novel foods accordingly. |
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(14)

The Commission should therefore authorise the placing on the market within the Union of infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora as such and update the Union list of novel foods accordingly.

| (15) | Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly, |
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(15)

Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner, as specified in the Annex to this Regulation, shall be included in the Union list of authorised novel foods established in 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 to this Regulation.

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, 1 July 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) 2017/2468 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).

2

(3)  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

(4)  EFSA Supporting Publication, 2020:EN-1783.

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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) in alphabetical order:

  ‘










  Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
| --- | --- | --- | --- | --- |
| “Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner
  (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 ‘Infusion from coffee leaves of Coffea arabica and/or Coffea canephora’.” | |
| Herbal infusions | |

(1)

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

‘

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

“Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner

(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 ‘Infusion from coffee leaves of Coffea arabica and/or Coffea canephora’.”

Herbal infusions

’

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

  ‘







  Authorised Novel Food | Specifications |
| --- | --- | --- |
| “Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner
  (Traditional food from a third country) | Description/Definition:

  The traditional food consists of an infusion of leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner (family: Rubiaceae).
  The traditional food is prepared by mixing a maximum of 20 g of dried leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner with 1 L of hot water. Leaves are removed and the infusion is then subjected to pasteurization (at least 71 °C for 15 seconds).

  Composition:

  Visual: Brown green liquid
  Odour and taste: Characteristic
  Chlorogenic acid (5-CQA): < 100 mg/L
  Caffeine: < 80 mg/L
  Epigallocatechin gallate (EGCG): < 700 mg/L

  Microbiological criteria:

  Total plate count: < 500 CFU/g
  Total yeast and mould count: < 100 CFU/g
  Total coliforms: < 100 CFU/g

  Escherichia coli: Absence in 1 g

  Salmonella: Absence in 25 g

  Heavy metals:

  Lead (Pb): < 3,0 mg/L
  Arsenic (As): < 2,0 mg/L
  Cadmium (Cd): < 1,0 mg/L
  CFU: Colony Forming Units” |

(2)

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

‘

Authorised Novel Food

Specifications

“Infusion from coffee leaves of Coffea arabica L. and/or Coffea canephora Pierre ex A. Froehner

(Traditional food from a third country)

Description/Definition:

The traditional food consists of an infusion of leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner (family: Rubiaceae).

The traditional food is prepared by mixing a maximum of 20 g of dried leaves from Coffea arabica L. and/or Coffea canephora Pierre ex A.Froehner with 1 L of hot water. Leaves are removed and the infusion is then subjected to pasteurization (at least 71 °C for 15 seconds).

Composition:

Visual: Brown green liquid

Odour and taste: Characteristic

Chlorogenic acid (5-CQA): < 100 mg/L

Caffeine: < 80 mg/L

Epigallocatechin gallate (EGCG): < 700 mg/L

Microbiological criteria:

Total plate count: < 500 CFU/g

Total yeast and mould count: < 100 CFU/g

Total coliforms: < 100 CFU/g

Escherichia coli: Absence in 1 g

Salmonella: Absence in 25 g

Heavy metals:

Lead (Pb): < 3,0 mg/L

Arsenic (As): < 2,0 mg/L

Cadmium (Cd): < 1,0 mg/L

CFU: Colony Forming Units”

’

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