# Official Journal L 13/2018

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 13 |
| | |
| English edition | Legislation | Volume 6118 January 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 13

English edition

Legislation

Volume 6118 January 2018

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2018/72 of 4 October 2017 supplementing Regulation (EU) 2015/751 of the European Parliament and of the Council on interchange fees for card-based payment transactions with regard to regulatory technical standards establishing the requirements to be complied with by payment card schemes and processing entities to ensure the application of independence requirements in terms of accounting, organisation and decision-making process (
  1
  ) | 1 |
| | * | Commission Regulation (EU) 2018/73 of 16 January 2018 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for mercury compounds in or on certain products (
  1
  ) | 8 |
| | * | Commission Regulation (EU) 2018/74 of 17 January 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452) in frozen vertical meat spits (
  1
  ) | 21 |
| | * | Commission Regulation (EU) 2018/75 of 17 January 2018 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for Microcrystalline cellulose (E460(i)) (
  1
  ) | 24 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2018/72 of 4 October 2017 supplementing Regulation (EU) 2015/751 of the European Parliament and of the Council on interchange fees for card-based payment transactions with regard to regulatory technical standards establishing the requirements to be complied with by payment card schemes and processing entities to ensure the application of independence requirements in terms of accounting, organisation and decision-making process (
  1
  )

1

1

*

Commission Regulation (EU) 2018/73 of 16 January 2018 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for mercury compounds in or on certain products (
  1
  )

1

8

*

Commission Regulation (EU) 2018/74 of 17 January 2018 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452) in frozen vertical meat spits (
  1
  )

1

21

*

Commission Regulation (EU) 2018/75 of 17 January 2018 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for Microcrystalline cellulose (E460(i)) (
  1
  )

1

24

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Definitive adoption (EU, Euratom) 2017/30 of amending budget No 5 of the European Union for the financial year 2017 ( OJ L 9, 12.1.2018 ) | 27 |

Corrigenda

*

Corrigendum to Definitive adoption (EU, Euratom) 2017/30 of amending budget No 5 of the European Union for the financial year 2017 ( OJ L 9, 12.1.2018 )

( OJ L 9, 12.1.2018 )

27

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 18.1.2018 | EN | Official Journal of the European Union | L 13/1 |
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18.1.2018

EN

Official Journal of the European Union

L 13/1

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COMMISSION DELEGATED REGULATION (EU) 2018/72

of 4 October 2017

supplementing Regulation (EU) 2015/751 of the European Parliament and of the Council on interchange fees for card-based payment transactions with regard to regulatory technical standards establishing the requirements to be complied with by payment card schemes and processing entities to ensure the application of independence requirements in terms of accounting, organisation and decision-making process

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/751 of 29 April 2015 of the European Parliament and of the Council on interchange fees for card-based payment transactions (1) and in particular Article 7(6) thereof,

Whereas:

| (1) | In order to specify the requirements ensuring separation of payment card schemes and processing entities, it is appropriate to define certain terms in relation to the accounting, organisation and the decision making process of payment card schemes and processing entities, irrespective of the legal form adopted by those entities. |
| --- | --- |

(1)

In order to specify the requirements ensuring separation of payment card schemes and processing entities, it is appropriate to define certain terms in relation to the accounting, organisation and the decision making process of payment card schemes and processing entities, irrespective of the legal form adopted by those entities.

| (2) | Payment card schemes and processing entities should have accounting processes in place that enable them to produce financial information on separated profit and loss accounts and explanatory notes to that financial information. Those requirements should not replace or amend accounting principles and standards or requirements concerning the annual financial statements that already apply to payment card schemes and processing entities. |
| --- | --- |

(2)

Payment card schemes and processing entities should have accounting processes in place that enable them to produce financial information on separated profit and loss accounts and explanatory notes to that financial information. Those requirements should not replace or amend accounting principles and standards or requirements concerning the annual financial statements that already apply to payment card schemes and processing entities.

| (3) | For that purpose, it is appropriate to specify how expenses and revenues should be allocated under those accounting processes. Those accounting processes should be duly documented, in particular in relation to transfers of funds between payment card schemes and processing entities. |
| --- | --- |

(3)

For that purpose, it is appropriate to specify how expenses and revenues should be allocated under those accounting processes. Those accounting processes should be duly documented, in particular in relation to transfers of funds between payment card schemes and processing entities.

| (4) | In order to ensure independence, payment card schemes and participating processing entities should produce financial information at least annually and that information should be reviewed by an independent auditor. That information as well as its review should be made available to competent authorities upon their request to enable them to ensure enforcement of independence requirements. |
| --- | --- |

(4)

In order to ensure independence, payment card schemes and participating processing entities should produce financial information at least annually and that information should be reviewed by an independent auditor. That information as well as its review should be made available to competent authorities upon their request to enable them to ensure enforcement of independence requirements.

| (5) | Payment card schemes and processing entities that are not separate legal persons should at least be organised as different internal business units. Staff of payment card schemes and staff of the processing entities, including senior management, should be independent and accommodated in separated workspaces equipped with restricted controlled access. To promote the independence of senior managers when two entities are part of the same group and to prevent the practice of ‘revolving doors’, senior managers should be prohibited from taking on work for the other side of the business for a minimum duration of one year after they have left the entity they were working for. |
| --- | --- |

(5)

Payment card schemes and processing entities that are not separate legal persons should at least be organised as different internal business units. Staff of payment card schemes and staff of the processing entities, including senior management, should be independent and accommodated in separated workspaces equipped with restricted controlled access. To promote the independence of senior managers when two entities are part of the same group and to prevent the practice of ‘revolving doors’, senior managers should be prohibited from taking on work for the other side of the business for a minimum duration of one year after they have left the entity they were working for.

| (6) | Staff of payment card schemes should only be allowed to perform tasks related to the design, update or implementation of processing services where specific conditions ensuring compliance with independence requirements are met. |
| --- | --- |

(6)

Staff of payment card schemes should only be allowed to perform tasks related to the design, update or implementation of processing services where specific conditions ensuring compliance with independence requirements are met.

| (7) | To avoid any incentives for payment card schemes or for processing entities to provide each other, via their staff, with preferential treatment or privileged information not available to their competitors, remuneration frameworks for staff of payment card schemes and of processing entities should not be based directly or indirectly on the economic performance of the processing entities or the payment card schemes. Remuneration policies should be made fully available to competent authorities upon their request. |
| --- | --- |

(7)

To avoid any incentives for payment card schemes or for processing entities to provide each other, via their staff, with preferential treatment or privileged information not available to their competitors, remuneration frameworks for staff of payment card schemes and of processing entities should not be based directly or indirectly on the economic performance of the processing entities or the payment card schemes. Remuneration policies should be made fully available to competent authorities upon their request.

| (8) | It is appropriate to specify that when the payment card scheme and the processing entity are part of the same legal entity or group, rules for ensuring compliance of staff with the current Regulation should be laid down in a code of conduct with effective sanctions and enforcement mechanisms that should be made public. |
| --- | --- |

(8)

It is appropriate to specify that when the payment card scheme and the processing entity are part of the same legal entity or group, rules for ensuring compliance of staff with the current Regulation should be laid down in a code of conduct with effective sanctions and enforcement mechanisms that should be made public.

| (9) | Payment card schemes and processing entities should be allowed to use shared services provided that this usage does not result in sharing sensitive information between them and that the conditions for sharing the services, including the financial conditions under which those services are offered, are duly documented in a single document. That document should be made available to competent authorities upon their request to enable them to ensure the application of independence requirements. Specific conditions for the sharing of the information management system should be introduced. Sharing of sensitive information between payment card schemes and processing entities which may give either the payment scheme or the processing entity a competitive advantage should however be prohibited. |
| --- | --- |

(9)

Payment card schemes and processing entities should be allowed to use shared services provided that this usage does not result in sharing sensitive information between them and that the conditions for sharing the services, including the financial conditions under which those services are offered, are duly documented in a single document. That document should be made available to competent authorities upon their request to enable them to ensure the application of independence requirements. Specific conditions for the sharing of the information management system should be introduced. Sharing of sensitive information between payment card schemes and processing entities which may give either the payment scheme or the processing entity a competitive advantage should however be prohibited.

| (10) | It is appropriate to set out conditions for the composition of the management bodies of the payments card schemes and processing entities, irrespective of their legal form and organisational arrangements, to ensure that potential conflicts of interest for the decision making process between the payment card schemes and processing entities are appropriately mitigated. Those conditions should be made public and subject to review by competent authorities. Furthermore, payment card schemes and processing entities should have separated annual operating plans approved by their relevant management bodies. Those separated annual operating plans should be made fully available to competent authorities upon their request, to enable them to ensure enforcement of independence requirements. |
| --- | --- |

(10)

It is appropriate to set out conditions for the composition of the management bodies of the payments card schemes and processing entities, irrespective of their legal form and organisational arrangements, to ensure that potential conflicts of interest for the decision making process between the payment card schemes and processing entities are appropriately mitigated. Those conditions should be made public and subject to review by competent authorities. Furthermore, payment card schemes and processing entities should have separated annual operating plans approved by their relevant management bodies. Those separated annual operating plans should be made fully available to competent authorities upon their request, to enable them to ensure enforcement of independence requirements.

| (11) | This Regulation is based on the draft regulatory technical standards submitted by the European Banking Authority (‘EBA’) to the Commission. |
| --- | --- |

(11)

This Regulation is based on the draft regulatory technical standards submitted by the European Banking Authority (‘EBA’) to the Commission.

| (12) | EBA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2), |
| --- | --- |

(12)

EBA has conducted open public consultations on the draft regulatory technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter

This Regulation establishes the requirements to be complied with by payment card schemes and processing entities to ensure the application of Article 7(1)(a) of Regulation (EU) 2015/751.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

| (1) | ‘management body’ means a payment card scheme's or processing entity's body appointed in accordance with national law, which is empowered to set the entity's strategy, objectives and overall direction and which oversees and monitors management decision-making, and includes the persons who effectively direct the business of the entity; |
| --- | --- |

(1)

‘management body’ means a payment card scheme's or processing entity's body appointed in accordance with national law, which is empowered to set the entity's strategy, objectives and overall direction and which oversees and monitors management decision-making, and includes the persons who effectively direct the business of the entity;

| (2) | ‘senior management’ means those natural persons within a payment card scheme or processing entity who exercise executive functions and who are responsible and accountable to the management body for the day-to-day management of the payment card scheme or processing entity; |
| --- | --- |

(2)

‘senior management’ means those natural persons within a payment card scheme or processing entity who exercise executive functions and who are responsible and accountable to the management body for the day-to-day management of the payment card scheme or processing entity;

| (3) | ‘remuneration’ means all forms of fixed and variable remuneration, including payments made or benefits, monetary or non-monetary, awarded directly by or on behalf of the payment card scheme or processing entity to employees; |
| --- | --- |

(3)

‘remuneration’ means all forms of fixed and variable remuneration, including payments made or benefits, monetary or non-monetary, awarded directly by or on behalf of the payment card scheme or processing entity to employees;

| (4) | ‘shared services’ means any activity, function or service performed by either an internal unit within a payment card scheme or processing entity or a separate legal entity and executed to the benefit of both the payment card scheme and the processing entity; |
| --- | --- |

(4)

‘shared services’ means any activity, function or service performed by either an internal unit within a payment card scheme or processing entity or a separate legal entity and executed to the benefit of both the payment card scheme and the processing entity;

| (5) | ‘group’ means a parent undertaking and all its subsidiary undertakings as defined in Article 2(11) of Directive (EU) 2013/34 of the European Parliament and of the Council (3). |
| --- | --- |

(5)

‘group’ means a parent undertaking and all its subsidiary undertakings as defined in Article 2(11) of Directive (EU) 2013/34 of the European Parliament and of the Council (3).

3

CHAPTER II

ACCOUNTING

Article 3

Financial information

1.   Payment card schemes and participating processing entities, shall have accounting processes in place that enable them to produce financial information on separated profit and loss accounts and explanatory notes to that financial information.

2.   The financial information referred to in paragraph 1 shall comply with the applicable accounting framework for preparing financial statements of payment card schemes and processing entities.

Article 4

Allocation of expenses and revenues

1.   The financial information referred to in Article 3(1) shall be based on an allocation of expenses and revenues between the payment card scheme and the processing entity in accordance with the following rules:

| (a) | expenses and revenues that are directly attributable to the provision of processing services shall be allocated to the processing entity; |
| --- | --- |

(a)

expenses and revenues that are directly attributable to the provision of processing services shall be allocated to the processing entity;

| (b) | expenses and revenues that are directly attributable to the payment card scheme shall be allocated to the payment card scheme; |
| --- | --- |

(b)

expenses and revenues that are directly attributable to the payment card scheme shall be allocated to the payment card scheme;

| (c) | expenses and revenues that are not directly attributable to the provision of processing services or to the payment card scheme shall be allocated on an activity-based costing (‘ABC’), which involves allocating indirect costs and revenues according to the actual consumption by the processing services entity or by the payment card scheme; |
| --- | --- |

(c)

expenses and revenues that are not directly attributable to the provision of processing services or to the payment card scheme shall be allocated on an activity-based costing (‘ABC’), which involves allocating indirect costs and revenues according to the actual consumption by the processing services entity or by the payment card scheme;

| (d) | expenses and revenues that are not directly attributable and cannot be allocated on ABC shall be allocated according to an accounting methodology documented in a supporting note. |
| --- | --- |

(d)

expenses and revenues that are not directly attributable and cannot be allocated on ABC shall be allocated according to an accounting methodology documented in a supporting note.

2.   The supporting note referred to in paragraph 1(d) shall indicate for each allocated cost and revenue under that methodology:

| (a) | the basis for the allocation; |
| --- | --- |

(a)

the basis for the allocation;

| (b) | the rationale for that basis. |
| --- | --- |

(b)

the rationale for that basis.

Article 5

Documentation of transfer of financial resources between payment card schemes and processing entities

1.   Payment card schemes and processing entities shall produce specific explanatory notes for any transfer of financial resources between them for the provision of services or the use of shared services as referred to in Article 12. Those explanatory notes shall specify the prices of and fees for those services, irrespective of any underlying obligations and organisational arrangements that may exist between them. Those explanatory notes shall be included in the financial information referred to in Article 3(1).

2.   Where payment card schemes and processing entities belong to the same legal entity or group, the specific explanatory notes referred to in paragraph 1 shall provide evidence that the prices and fees for the provision of services between them or the use of shared services do not differ from prices and fees for the same or, in absence thereof, comparable services charged between payment card schemes and processing entities that do not belong to the same legal entity or group.

Article 6

Review and frequency of financial information

1.   The financial information produced in accordance with Articles 3, 4 and 5 shall be reviewed by an independent and certified auditor.

2.   The review referred to in paragraph 1 shall be provided in the form of a report ensuring:

| (a) | a trustworthy and fair view of the financial information produced by payment card schemes and processing entities; |
| --- | --- |

(a)

a trustworthy and fair view of the financial information produced by payment card schemes and processing entities;

| (b) | consistency and comparability of the financial information with the accounting frameworks for preparing financial statements of payment card schemes and processing entities; |
| --- | --- |

(b)

consistency and comparability of the financial information with the accounting frameworks for preparing financial statements of payment card schemes and processing entities;

| (c) | consistency of the financial information with previous years' allocation policies or, where such consistency is lacking, an explanation as to why the allocation policy has been changed and a restatement of previous years' figures. |
| --- | --- |

(c)

consistency of the financial information with previous years' allocation policies or, where such consistency is lacking, an explanation as to why the allocation policy has been changed and a restatement of previous years' figures.

3.   The financial information referred to in Articles 3, 4 and 5 shall be submitted to the auditor referred to in paragraph 1 annually and shall be made fully available to competent authorities upon their request, together with the review by the independent auditor.

CHAPTER III

ORGANISATION

Article 7

Functional separation

Payment card schemes and processing entities that are not established as two separate legal entities shall be organised in two separate internal business units.

Article 8

Separation of workspaces

Payment card schemes and the processing entities that are located in the same premises shall be organised in separate workspaces equipped with restricted and controlled access.

Article 9

Independence of senior management

The senior management of payment card schemes or of the payment card scheme business unit shall be different from the senior management of processing entities or of the processing entity business unit, and act autonomously. The senior management of payment card schemes or payment card scheme business units shall not be allowed to take on work for processing entities or processing entity business units, and vice versa, for a minimum duration of one year after that senior management left the entity for which they have been working.

Article 10

Independence of staff

1.   The staff of payment card schemes shall be different from the staff of processing entities.

2.   The staff of payment card schemes and of processing entities may perform tasks related to the provision of shared services as referred to in Article 12.

3.   The staff of a processing entity may perform tasks related to the design of the single set of rules, practices, standards and implementation guidelines for the execution of card-based payment transactions, provided that:

| (a) | the tasks related to the design of the single set of rules may be performed by other processing entities on a non-discriminatory basis; |
| --- | --- |

(a)

the tasks related to the design of the single set of rules may be performed by other processing entities on a non-discriminatory basis;

| (b) | the design of those rules involves a representative sample of all processing entities participating in the payment card scheme. |
| --- | --- |

(b)

the design of those rules involves a representative sample of all processing entities participating in the payment card scheme.

Article 11

Remuneration

1.   Processing entities shall adopt remuneration policies that do not create incentives for their staff to provide a payment card scheme with preferential treatment or privileged information which is not available to other competitors. Remuneration of their staff shall therefore reflect the performance of the processing entity and shall not be directly or indirectly linked to the performance of the payment card scheme to which the processing entity provides services.

2.   Payment card schemes shall adopt remuneration policies that do not create incentives for their staff to provide a processing entity with preferential treatment or privileged information which is not available to other competitors. Remuneration of their staff shall therefore reflect the performance of the payment card schemes and shall not be directly or indirectly linked to the performance of a processing entity.

3.   Remuneration policies referred to in paragraphs 1 and 2 shall be made fully available to competent authorities upon their request.

Article 12

Use of shared services

1.   Payment card schemes and processing entities making use of shared services shall describe in a single document the list of shared services and the conditions, including the financial conditions, under which those services are provided.

2.   The single document referred to in paragraph 1 shall be made available to competent authorities upon their request.

Article 13

Use of a shared information management system

An information management system that is shared by a payment card scheme and a processing entity shall ensure that:

| (a) | the staff of the payment card scheme and of the processing entity are separately identified via the authentication procedure to access the information management system; |
| --- | --- |

(a)

the staff of the payment card scheme and of the processing entity are separately identified via the authentication procedure to access the information management system;

| (b) | users only have access to information which they are entitled to in compliance with this Regulation. In particular, any sensitive information, as referred to in Article 14, of a processing entity shall not be accessed by the staff of the payment card scheme and any sensitive information of a payment card scheme shall not be accessed by the staff of the processing entity. |
| --- | --- |

(b)

users only have access to information which they are entitled to in compliance with this Regulation. In particular, any sensitive information, as referred to in Article 14, of a processing entity shall not be accessed by the staff of the payment card scheme and any sensitive information of a payment card scheme shall not be accessed by the staff of the processing entity.

Article 14

Sensitive information

Payment card schemes and processing entities shall not share information of a sensitive nature that provides a competitive advantage to either the payment scheme or the processing entity where such information is not shared with other competitors.

Article 15

Code of conduct

1.   Payment card schemes and processing entities which belong to the same legal entity or group shall define and disclose publicly on their website a code of conduct, setting out how their respective staff shall act to ensure compliance with this Regulation. The code of conduct shall also set effective enforcement mechanisms.

2.   The code of conduct shall, in particular, define rules to prevent the sharing of sensitive information, as referred to in Article 14 between payment card schemes and processing entities. The code of conduct shall be subject to review by competent authorities.

CHAPTER IV

DECISION-MAKING PROCESS

Article 16

Independence of the management bodies

1.   Payment card schemes and processing entities shall ensure that the composition of their management bodies mitigates conflicts of interest for the decision making process between the payment card scheme and the processing entity, including by setting clear and objective criteria under which directorships may be held by the same person at the same time in the management body of the payment card scheme and of the processing entity. Those criteria shall be made public and shall be subject to review by competent authorities.

2.   The management bodies of payment card schemes and processing entities that belong to the same legal entity or group shall approve and periodically review conflict of interest policies for managing and monitoring the compliance with this Regulation.

3.   For the purposes of paragraph 2 and where directorships may be held by the same person in the management body of the payment card scheme and of the processing entity, payment card schemes and processing entities shall establish:

| (a) | a separate management body responsible for decisions related to the payment card scheme activities, with the exemption of shared services referred to in Article 12, and which shall be composed of members of the management body that do not perform any executive function in relation to processing activities. Those members shall advise the management body on the payment card scheme strategy in compliance with this Regulation and assist the management body in overseeing the implementation of that strategy by senior management; |
| --- | --- |

(a)

a separate management body responsible for decisions related to the payment card scheme activities, with the exemption of shared services referred to in Article 12, and which shall be composed of members of the management body that do not perform any executive function in relation to processing activities. Those members shall advise the management body on the payment card scheme strategy in compliance with this Regulation and assist the management body in overseeing the implementation of that strategy by senior management;

| (b) | a separate management body responsible for decisions related to the processing activities, with the exemption of shared services referred to in Article 12, and which shall be composed of members of the management body that do not perform any executive function in relation to payment card scheme activities. Those members shall advise the management body on the processing entity strategy in compliance with this Regulation and assist the management body in overseeing the implementation of that strategy by senior management; |
| --- | --- |

(b)

a separate management body responsible for decisions related to the processing activities, with the exemption of shared services referred to in Article 12, and which shall be composed of members of the management body that do not perform any executive function in relation to payment card scheme activities. Those members shall advise the management body on the processing entity strategy in compliance with this Regulation and assist the management body in overseeing the implementation of that strategy by senior management;

| (c) | independent reporting lines from the senior management of either the payment card scheme business unit or of the processing entity business unit, as applicable, to the management body. |
| --- | --- |

(c)

independent reporting lines from the senior management of either the payment card scheme business unit or of the processing entity business unit, as applicable, to the management body.

4.   The organisational arrangements established in accordance with paragraph 3 shall be made available to competent authorities upon their request.

5.   The management body shall retain overall responsibility for ensuring compliance with this Regulation.

Article 17

Annual operating plan independence

1.   Payment card schemes and processing entities shall have separate annual operating plans determining the budget, including capital and operating expenditures and possible authority delegations to engage those expenditures, which shall be submitted to their respective management body for approval or, where relevant, to the management body referred to in Article 16.

2.   The separated annual operating plans shall be made fully available to competent authorities upon their request.

CHAPTER V

FINAL PROVISIONS

Article 18

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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 October 2017.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 123, 19.5.2015, p. 1.

1

(2)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

2

(3)  Directive 2013/34/EU of the European Parliament and of the Council of 26 June 2013 on the annual financial statements, consolidated financial statements and related reports of certain types of undertakings, amending Directive 2006/43/EC of the European Parliament and of the Council and repealing Council Directives 78/660/EEC and 83/349/EEC (OJ L 182, 29.6.2013, p. 19).

3

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| 18.1.2018 | EN | Official Journal of the European Union | L 13/8 |
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18.1.2018

EN

Official Journal of the European Union

L 13/8

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COMMISSION REGULATION (EU) 2018/73

of 16 January 2018

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for mercury compounds in or on certain products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a) and Article 16(1)(a) thereof,

Whereas:

| (1) | For mercury compounds, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For mercury compounds, maximum residue levels (MRLs) were set in Annex II and Part B of Annex III to Regulation (EC) No 396/2005.

| (2) | Council Directive 79/117/EEC prohibited the placing on the market and use of plant protection products containing mercury compounds. All authorisations of plant protection products containing mercury compounds were revoked and consequently all MRLs were set at the relevant limit of determination (LOD). |
| --- | --- |

(2)

Council Directive 79/117/EEC prohibited the placing on the market and use of plant protection products containing mercury compounds. All authorisations of plant protection products containing mercury compounds were revoked and consequently all MRLs were set at the relevant limit of determination (LOD).

| (3) | The Commission received information from food business operators and Member States showing the presence of mercury compounds in several products leading to higher residues than the LOD laid down in Regulation (EC) No 396/2005. |
| --- | --- |

(3)

The Commission received information from food business operators and Member States showing the presence of mercury compounds in several products leading to higher residues than the LOD laid down in Regulation (EC) No 396/2005.

| (4) | Recent monitoring data confirms that residues of mercury compounds occur in several products at levels higher than the LOD. Taking into account the 95th percentile of all the sample results, the following occurrences were reported: tree nuts at 0,02 mg/kg; fresh herbs at 0,03 mg/kg; cultivated fungi at 0,05 mg/kg; wild fungi at 0,50 mg/kg, except for ceps at 0,90 mg/kg; oilseeds at 0,02 mg/kg; teas, coffee beans, herbal infusions and cocoa beans at 0,02 mg/kg; spices at 0,02 mg/kg, except ginger, nutmeg, mace and turmeric at 0,05 mg/kg; meat at 0,01 mg/kg, except for meat of wild game animals at 0,015 mg/kg and duck meat (farmed and wild) at 0,04 mg/kg; animal fat at 0,01 mg/kg; edible offal at 0,02 mg/kg except for offal of wild game animals at 0,025 mg/kg and offal of wild boar at 0,10 mg/kg; milk at 0,01 mg/kg; and honey at 0,01 mg/kg. |
| --- | --- |

(4)

Recent monitoring data confirms that residues of mercury compounds occur in several products at levels higher than the LOD. Taking into account the 95th percentile of all the sample results, the following occurrences were reported: tree nuts at 0,02 mg/kg; fresh herbs at 0,03 mg/kg; cultivated fungi at 0,05 mg/kg; wild fungi at 0,50 mg/kg, except for ceps at 0,90 mg/kg; oilseeds at 0,02 mg/kg; teas, coffee beans, herbal infusions and cocoa beans at 0,02 mg/kg; spices at 0,02 mg/kg, except ginger, nutmeg, mace and turmeric at 0,05 mg/kg; meat at 0,01 mg/kg, except for meat of wild game animals at 0,015 mg/kg and duck meat (farmed and wild) at 0,04 mg/kg; animal fat at 0,01 mg/kg; edible offal at 0,02 mg/kg except for offal of wild game animals at 0,025 mg/kg and offal of wild boar at 0,10 mg/kg; milk at 0,01 mg/kg; and honey at 0,01 mg/kg.

| (5) | As mercury containing pesticides have been phased out since more than thirty years in the Union, the presence of mercury in food can be considered due to environmental contamination. It is therefore appropriate to replace the default values with the ones listed in recital 4, thus reflecting environmental background of mercury in Regulation (EC) No 396/2005. This will enable national competent authorities to take appropriate enforcement action on the basis of realistic MRLs. |
| --- | --- |

(5)

As mercury containing pesticides have been phased out since more than thirty years in the Union, the presence of mercury in food can be considered due to environmental contamination. It is therefore appropriate to replace the default values with the ones listed in recital 4, thus reflecting environmental background of mercury in Regulation (EC) No 396/2005. This will enable national competent authorities to take appropriate enforcement action on the basis of realistic MRLs.

| (6) | The Scientific Panel on contaminants in the Food Chain (CONTAM Panel) of the European Food Safety Authority, hereinafter ‘the Authority’, adopted an opinion on mercury and methylmercury in food (2). |
| --- | --- |

(6)

The Scientific Panel on contaminants in the Food Chain (CONTAM Panel) of the European Food Safety Authority, hereinafter ‘the Authority’, adopted an opinion on mercury and methylmercury in food (2).

| (7) | As mercury compounds occur at low levels in the products listed in recital 4 and taking into account the available consumption data within the Union, the overall contribution to the dietary exposure is considered low and there is no health risk for consumers. The MRLs for those products should be set as temporary in Annex III to Regulation (EC) No 396/2005. Those MRLs will be reviewed; the review will take into account the information available within 10 years from the publication of this Regulation. |
| --- | --- |

(7)

As mercury compounds occur at low levels in the products listed in recital 4 and taking into account the available consumption data within the Union, the overall contribution to the dietary exposure is considered low and there is no health risk for consumers. The MRLs for those products should be set as temporary in Annex III to Regulation (EC) No 396/2005. Those MRLs will be reviewed; the review will take into account the information available within 10 years from the publication of this Regulation.

| (8) | The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt the LODs. Those laboratories concluded that the current LODs should be maintained. |
| --- | --- |

(8)

The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt the LODs. Those laboratories concluded that the current LODs should be maintained.

| (9) | Based on the opinion of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. |
| --- | --- |

(9)

Based on the opinion of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

| (10) | Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account. |
| --- | --- |

(10)

Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

| (11) | Regulation (EC) No 396/2005 should therefore be amended accordingly. |
| --- | --- |

(11)

Regulation (EC) No 396/2005 should therefore be amended accordingly.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

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

Annexes II and III to Regulation (EC) No 396/2005 are 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, 16 January 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 70, 16.3.2005, p. 1.

1

(2)  EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on the risk for public health related to the presence of mercury and methylmercury in food. EFSA Journal 2012;10(12):2985. [241 pp.].

2

---

ANNEX

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

| (1) | In Annex II, the column for mercury compounds is deleted. |
| --- | --- |

(1)

In Annex II, the column for mercury compounds is deleted.

| (2) | Annex III is amended as follows:






  (a) | In Part A, the column for mercury compounds is added:

  ‘Pesticide residues and maximum residue levels (mg/kg)








  Code number | Groups and examples of individual products to which the MRLs apply (1) | Mercury compounds (sum of mercury compounds expressed as mercury) |
| --- | --- | --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | |
| 0110000 | Citrus fruits | 0,01 (*1) |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others | |
| 0120000 | Tree nuts | 0,02 (+) |
| 0120010 | Almonds | |
| 0120020 | Brazil nuts | |
| 0120030 | Cashew nuts | |
| 0120040 | Chestnuts | |
| 0120050 | Coconuts | |
| 0120060 | Hazelnuts/cobnuts | |
| 0120070 | Macadamias | |
| 0120080 | Pecans | |
| 0120090 | Pine nut kernels | |
| 0120100 | Pistachios | |
| 0120110 | Walnuts | |
| 0120990 | Others | |
| 0130000 | Pome fruits | 0,01 (*1) |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others | |
| 0140000 | Stone fruits | 0,01 (*1) |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others | |
| 0150000 | Berries and small fruits | 0,01 (*1) |
| 0151000 | (a) | grapes |

(2)

Annex III is amended as follows:

(a)

In Part A, the column for mercury compounds is added:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (1)

Mercury compounds (sum of mercury compounds expressed as mercury)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,01 (*1)

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

0120000

Tree nuts

0,02 (+)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

Pome fruits

0,01 (*1)

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others

0140000

Stone fruits

0,01 (*1)

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0150000

Berries and small fruits

0,01 (*1)

0151000

(a)

0151010

Table grapes

0151020

Wine grapes

0152000

| (b) | strawberries |
| --- | --- |

(b)

0153000

| (c) | cane fruits |
| --- | --- |

(c)

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others

0154000

| (d) | other small fruits and berries |
| --- | --- |

(d)

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others

0160000

Miscellaneous fruits with

0,01 (*1)

0161000

| (a) | edible peel |
| --- | --- |

(a)

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others

0162000

| (b) | inedible peel, small |
| --- | --- |

(b)

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others

0163000

| (c) | inedible peel, large |
| --- | --- |

(c)

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01 (*1)

0211000

| (a) | potatoes |
| --- | --- |

(a)

0212000

| (b) | tropical root and tuber vegetables |
| --- | --- |

(b)

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others

0213000

| (c) | other root and tuber vegetables except sugar beets |
| --- | --- |

(c)

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others

0220000

Bulb vegetables

0,01 (*1)

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others

0230000

Fruiting vegetables

0,01 (*1)

0231000

| (a) | solanacea |
| --- | --- |

(a)

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

0231040

Okra/lady's fingers

0231990

Others

0232000

| (b) | cucurbits with edible peel |
| --- | --- |

(b)

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others

0233000

| (c) | cucurbits with inedible peel |
| --- | --- |

(c)

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others

0234000

| (d) | sweet corn |
| --- | --- |

(d)

0239000

| (e) | other fruiting vegetables |
| --- | --- |

(e)

0240000

Brassica vegetables (excluding brassica roots and brassica baby leaf crops)

0,01 (*1)

0241000

| (a) | flowering brassica |
| --- | --- |

(a)

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0242000

| (b) | head brassica |
| --- | --- |

(b)

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others

0243000

| (c) | leafy brassica |
| --- | --- |

(c)

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others

0244000

| (d) | kohlrabies |
| --- | --- |

(d)

0250000

Leaf vegetables, herbs and edible flowers

0251000

| (a) | lettuces and salad plants |
| --- | --- |

(a)

0,01 (*1)

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others

0252000

| (b) | spinaches and similar leaves |
| --- | --- |

(b)

0,01 (*1)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0253000

| (c) | grape leaves and similar species |
| --- | --- |

(c)

0,01 (*1)

0254000

| (d) | watercresses |
| --- | --- |

(d)

0,01 (*1)

0255000

| (e) | witloofs/Belgian endives |
| --- | --- |

(e)

0,01 (*1)

0256000

| (f) | herbs and edible flowers |
| --- | --- |

(f)

0,03 (+)

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leave

0256100

Tarragon

0256990

Others

0260000

Legume vegetables

0,01 (*1)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others

0270000

Stem vegetables

0,01 (*1)

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

Fungi, mosses and lichens

0280010

Cultivated fungi

0,05 (+)

0280020

Wild fungi

0,5 (+)

0280990

Mosses and lichens

0,01 (*1)

0290000

Algae and prokaryotes organisms

0,01 (*1)

0300000

PULSES

0,01 (*1)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others

0400000

OILSEEDS AND OIL FRUITS

0401000

Oilseeds

0,02 (+)

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others

0402000

Oil fruits

0402010

Olives for oil production

0,01 (*1)

0402020

Oil palms kernels

0,02 (*1)

0402030

Oil palms fruits

0,02 (*1)

0402040

Kapok

0,02 (*1)

0402990

Others

0,02 (*1)

0500000

CEREALS

0,01 (*1)

0500010

Barley

0500020

Buckwheat and other pseudo-cereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0610000

Teas

0,02 (+)

0620000

Coffee beans

0,02 (+)

0630000

Herbal infusions from

0,02 (+)

0631000

| (a) | flowers |
| --- | --- |

(a)

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

| (b) | leaves and herbs |
| --- | --- |

(b)

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

| (c) | roots |
| --- | --- |

(c)

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

| (d) | any other parts of the plant |
| --- | --- |

(d)

0640000

Cocoa beans

0,02 (+)

0650000

Carobs/Saint John's breads

0,02 (*1)

0700000

HOPS

0,02 (*1)

0800000

SPICES

(+)

0810000

Seed spices

0810010

Anise/aniseed

0,02

0810020

Black caraway/black cumin

0,02

0810030

Celery

0,02

0810040

Coriander

0,02

0810050

Cumin

0,02

0810060

Dill

0,02

0810070

Fennel

0,02

0810080

Fenugreek

0,02

0810090

Nutmeg

0,05

0810990

Others

0,02

0820000

Fruit spices

0,02

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others

0830000

Bark spices

0,02

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,02

0840020

Ginger

0,05

0840030

Turmeric/curcuma

0,05

0840040

Horseradish

0840990

Others

0,02

0850000

Bud spices

0,02

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,02

0860010

Saffron

0860990

Others

0870000

Aril spices

0870010

Mace

0,05

0870990

Others

0,02

0900000

SUGAR PLANTS

0,01 (*1)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

1011000

| (a) | swine |
| --- | --- |

(a)

(+)

1011010

Muscle

0,01

1011020

Fat tissue

0,01

1011030

Liver

0,02

1011040

Kidney

0,02

1011050

Edible offals (other than liver and kidney)

0,02

1011990

Others

0,01
   (*1)

1012000

| (b) | bovine |
| --- | --- |

(b)

(+)

1012010

Muscle

0,01

1012020

Fat tissue

0,01

1012030

Liver

0,02

1012040

Kidney

0,02

1012050

Edible offals (other than liver and kidney)

0,02

1012990

Others

0,01
   (*1)

1013000

| (c) | sheep |
| --- | --- |

(c)

(+)

1013010

Muscle

0,01

1013020

Fat tissue

0,01

1013030

Liver

0,02

1013040

Kidney

0,02

1013050

Edible offals (other than liver and kidney)

0,02

1013990

Others

0,01
   (*1)

1014000

| (d) | goat |
| --- | --- |

(d)

(+)

1014010

Muscle

0,01

1014020

Fat tissue

0,01

1014030

Liver

0,02

1014040

Kidney

0,02

1014050

Edible offals (other than liver and kidney)

0,02

1014990

Others

0,01
   (*1)

1015000

| (e) | equine |
| --- | --- |

(e)

(+)

1015010

Muscle

0,01

1015020

Fat tissue

0,01

1015030

Liver

0,02

1015040

Kidney

0,02

1015050

Edible offals (other than liver and kidney)

0,02

1015990

Others

0,01
   (*1)

1016000

| (f) | poultry |
| --- | --- |

(f)

1016010

Muscle

0,01 (+)

1016020

Fat tissue

0,01 (+)

1016030

Liver

0,02 (+)

1016040

Kidney

0,02 (+)

1016050

Edible offals (other than liver and kidney)

0,02 (+)

1016990

Others

0,01 (*1)

1017000

| (g) | other farmed terrestrial animals |
| --- | --- |

(g)

(+)

1017010

Muscle

0,01

1017020

Fat tissue

0,01

1017030

Liver

0,02

1017040

Kidney

0,02

1017050

Edible offals (other than liver and kidney)

0,02

1017990

Others

0,01
   (*1)

1020000

Milk

0,01 (+)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

Birds eggs

0,01 (*1)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others

1040000

Honey and other apiculture products

0,01 (+)

1050000

Amphibians and Reptiles

0,01
   (*1)

1060000

Terrestrial invertebrate animals

0,01
   (*1)

1070000

Wild terrestrial vertebrate animals

0,04 (+)

| (F) | = | Fat soluble |
| --- | --- | --- |

(F)

=

Fat soluble

Mercury compounds (sum of mercury compounds expressed as mercury)

| (+) | Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  0120000 | Tree nuts |
| --- | --- | --- |
| 0256000 | (f) | herbs and edible flowers |

(+)

Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

0120000

Tree nuts

0256000

(f)

0280010

Cultivated fungi

| (+) | The following MRL applies to ceps: 0,9 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  0280020 | Wild fungi |
| --- | --- | --- |

(+)

The following MRL applies to ceps: 0,9 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

0280020

Wild fungi

| (+) | Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  0401000 | Oilseeds |
| --- | --- | --- |
| 0610000 | Teas |
| 0620000 | Coffee beans |
| 0630000 | Herbal infusions from |
| 0640000 | Cocoa beans |
| 0800000 | SPICES |

(+)

Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

0401000

Oilseeds

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0640000

Cocoa beans

0800000

SPICES

| (+) | The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040 ) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040 ) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.







  0840040 | Horseradish |
| --- | --- | --- |

(+)

The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040 ) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040 ) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.

0840040

Horseradish

| (+) | Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  1011000 | (a) | Tissues from swine |
| --- | --- | --- | --- |

(+)

Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

1011000

(a)

1012000

| (b) | Tissues from bovine |
| --- | --- |

(b)

1013000

| (c) | Tissues from sheep |
| --- | --- |

(c)

1014000

| (d) | Tissues from goat |
| --- | --- |

(d)

1015000

| (e) | Tissues from equine |
| --- | --- |

(e)

| (+) | The following MRL applies to duck meat: 0,04 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  1016010 | Muscle (poultry) |
| --- | --- | --- |

(+)

The following MRL applies to duck meat: 0,04 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

1016010

Muscle (poultry)

| (+) | Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  1016020 | Fat tissue (poultry) |
| --- | --- | --- |
| 1016030 | Liver (poultry) |
| 1016040 | Kidney (poultry) |
| 1016050 | Edible offals (poultry) |
| 1017000 | (g) | Tissues from other farmed terrestrial animals |

(+)

Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

1016020

Fat tissue (poultry)

1016030

Liver (poultry)

1016040

Kidney (poultry)

1016050

Edible offals (poultry)

1017000

(g)

1020000

Milk

1040000

Honey and other apiculture products

| (+) | The following MRL applies to offal of wild boar: 0,1 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.







  1070000 | Wild terrestrial vertebrate animals’ |
| --- | --- | --- |

(+)

The following MRL applies to offal of wild boar: 0,1 mg/kg. Monitoring data show that residues occur due to environmental contamination. When re-viewing the MRL, the Commission will take into account the information available within 10 years from the date of publication.

1070000

Wild terrestrial vertebrate animals’

| (b) | In Part B, the column for mercury compounds is deleted. |
| --- | --- |

(b)

In Part B, the column for mercury compounds is deleted.

---

(*1)  Limit of analytical determination

(1)  For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

---

| 18.1.2018 | EN | Official Journal of the European Union | L 13/21 |
| --- | --- | --- | --- |

18.1.2018

EN

Official Journal of the European Union

L 13/21

---

COMMISSION REGULATION (EU) 2018/74

of 17 January 2018

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452) in frozen vertical meat spits

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,

Whereas:

| (1) | Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use. |
| --- | --- |

(1)

Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.

| (2) | That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application. |
| --- | --- |

(2)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application.

| (3) | On 28 August 2015 an application was submitted for the authorisation of the use of phosphoric acid, phosphates, diphosphates, triphosphates and polyphosphates (‘phosphates’) as a stabiliser and a humectant in frozen vertical meat spits falling under the food category 08.2 ‘Meat preparations as defined by Regulation (EC) No 853/2004’ in Part E of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
| --- | --- |

(3)

On 28 August 2015 an application was submitted for the authorisation of the use of phosphoric acid, phosphates, diphosphates, triphosphates and polyphosphates (‘phosphates’) as a stabiliser and a humectant in frozen vertical meat spits falling under the food category 08.2 ‘Meat preparations as defined by Regulation (EC) No 853/2004’ in Part E of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (4) | The use of phosphates is required for a partial extraction and breakdown of meat proteins to form a protein film on vertical meat spits to bond meat pieces together in order to ensure homogenous freezing and roasting. Furthermore, phosphates ensure that meat remains juicy during thawing and that vertical meat spits remain stable. Such technological need was recognised for frozen vertical rotating meat spits made of sheep, lamb, veal or beef treated with liquid seasoning or from poultry meat treated with or without liquid seasoning used alone or combined as well as sliced or minced and designed to be roasted by a food business operator. Thoroughly roasted meat strips are then consumed by the final consumer. |
| --- | --- |

(4)

The use of phosphates is required for a partial extraction and breakdown of meat proteins to form a protein film on vertical meat spits to bond meat pieces together in order to ensure homogenous freezing and roasting. Furthermore, phosphates ensure that meat remains juicy during thawing and that vertical meat spits remain stable. Such technological need was recognised for frozen vertical rotating meat spits made of sheep, lamb, veal or beef treated with liquid seasoning or from poultry meat treated with or without liquid seasoning used alone or combined as well as sliced or minced and designed to be roasted by a food business operator. Thoroughly roasted meat strips are then consumed by the final consumer.

| (5) | Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (the Authority) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health. |
| --- | --- |

(5)

Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission has to seek the opinion of the European Food Safety Authority (the Authority) in order to update the Union list of food additives set out in Annex II to Regulation (EC) No 1333/2008, except where the update in question is not liable to have an effect on human health.

| (6) | Safety of phosphates was evaluated by the Scientific Committee for Food which established the Maximum Tolerable Daily Intake of 70 mg/kg body weight expressed as phosphorus (3). Phosphates are authorised for use as food additives in a wide variety of foods including meat products and certain meat preparations. Thus it is not expected that the extension of use to frozen vertical meat spits will have a significant impact on the overall exposure to phosphates. In order to limit further exposure to added phosphates the extension of use should be restricted only to the frozen vertical meat spits for which the technological need was identified. |
| --- | --- |

(6)

Safety of phosphates was evaluated by the Scientific Committee for Food which established the Maximum Tolerable Daily Intake of 70 mg/kg body weight expressed as phosphorus (3). Phosphates are authorised for use as food additives in a wide variety of foods including meat products and certain meat preparations. Thus it is not expected that the extension of use to frozen vertical meat spits will have a significant impact on the overall exposure to phosphates. In order to limit further exposure to added phosphates the extension of use should be restricted only to the frozen vertical meat spits for which the technological need was identified.

| (7) | Since the extended use of those additives constitutes an update of the Union list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority. |
| --- | --- |

(7)

Since the extended use of those additives constitutes an update of the Union list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.

| (8) | Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly. |
| --- | --- |

(8)

Annex II to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

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

(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

Annex II to Regulation (EC) No 1333/2008 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, 17 January 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).

2

(3)  Reports of the Scientific Committee for Food, Twenty-fifth series, 1991, p. 13.

3

---

ANNEX

In Part E of Annex II to Regulation (EC) No 1333/2008, in food category 08.2 ‘Meat preparations as defined by Regulation (EC) No 853/2004’, the entry for phosphoric acid — phosphates — di-, tri- and polyphosphates (E 338-452) is replaced by the following:

| | ‘E 338-452 | Phosphoric acid — phosphates — di-, tri- and polyphosphates | 5 000 | (1) (4) | only breakfast sausages: in this product, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving the product its typical appearance; Finnish grey salted Christmas ham, burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat, Kasseler, Bräte, Surfleisch, toorvorst, šašlõkk, ahjupraad, Bílá klobása, Vinná klobása, Sváteční klobása, Syrová klobása and frozen vertical rotating meat spits made of sheep, lamb, veal and/or beef treated with liquid seasoning or from poultry meat treated with or without liquid seasoning used alone and/or combined as well as sliced and/or minced and designed to be roasted by a food business operator and then consumed by the final consumer’ |
| --- | --- | --- | --- | --- | --- |

‘E 338-452

Phosphoric acid — phosphates — di-, tri- and polyphosphates

5 000

(1) (4)

only breakfast sausages: in this product, the meat is minced in such a way so that the muscle and fat tissue are completely dispersed, so that fibre makes an emulsion with the fat, giving the product its typical appearance; Finnish grey salted Christmas ham, burger meat with a minimum vegetable and/or cereal content of 4 % mixed within the meat, Kasseler, Bräte, Surfleisch, toorvorst, šašlõkk, ahjupraad, Bílá klobása, Vinná klobása, Sváteční klobása, Syrová klobása and frozen vertical rotating meat spits made of sheep, lamb, veal and/or beef treated with liquid seasoning or from poultry meat treated with or without liquid seasoning used alone and/or combined as well as sliced and/or minced and designed to be roasted by a food business operator and then consumed by the final consumer’

---

| 18.1.2018 | EN | Official Journal of the European Union | L 13/24 |
| --- | --- | --- | --- |

18.1.2018

EN

Official Journal of the European Union

L 13/24

---

COMMISSION REGULATION (EU) 2018/75

of 17 January 2018

amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for Microcrystalline cellulose (E460(i))

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 14 thereof,

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
| --- | --- |

(1)

Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008.

| (2) | Those specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application. |
| --- | --- |

(2)

Those specifications may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application.

| (3) | On 8 February 2016 an application was submitted for the amendment of specifications concerning the food additive microcrystalline cellulose (E 460(i)). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
| --- | --- |

(3)

On 8 February 2016 an application was submitted for the amendment of specifications concerning the food additive microcrystalline cellulose (E 460(i)). The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

| (4) | The current specification as regards the solubility of the food additive microcrystalline cellulose (E 460(i)) states ‘Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution’. |
| --- | --- |

(4)

The current specification as regards the solubility of the food additive microcrystalline cellulose (E 460(i)) states ‘Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution’.

| (5) | The applicant requests that the solubility of this food additive is amended to ‘Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution’. |
| --- | --- |

(5)

The applicant requests that the solubility of this food additive is amended to ‘Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution’.

| (6) | In its opinion of 24 January 2017 (4) the European Food Safety Authority (‘the Authority’) concluded that the amendment to the specifications as regards the solubility of microcrystalline cellulose (E 460(i)) proposed by the applicant is not of a safety concern. However, the Authority recommended that the concentration of sodium hydroxide solution to be used in the solubility test should be indicated in the EU specifications. |
| --- | --- |

(6)

In its opinion of 24 January 2017 (4) the European Food Safety Authority (‘the Authority’) concluded that the amendment to the specifications as regards the solubility of microcrystalline cellulose (E 460(i)) proposed by the applicant is not of a safety concern. However, the Authority recommended that the concentration of sodium hydroxide solution to be used in the solubility test should be indicated in the EU specifications.

| (7) | Consequently, it is appropriate to amend the description of the solubility of the food additive microcrystalline cellulose (E 460(i)) in sodium hydroxide solution (concentration: 50 g NaOH/L) to ‘practically insoluble or insoluble’. |
| --- | --- |

(7)

Consequently, it is appropriate to amend the description of the solubility of the food additive microcrystalline cellulose (E 460(i)) in sodium hydroxide solution (concentration: 50 g NaOH/L) to ‘practically insoluble or insoluble’.

| (8) | Regulation (EU) No 231/2012 should therefore be amended accordingly. |
| --- | --- |

(8)

Regulation (EU) No 231/2012 should therefore be amended accordingly.

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

(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

The Annex to Regulation (EU) No 231/2012 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 Members States.

Done at Brussels, 17 January 2018.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

3

(4)  EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to food), 2017. Safety of the proposed amendment of the specifications for microcrystalline cellulose (E 460(i)) as a food additive. EFSA Journal 2017;15(2):4699, 7 pp. doi:10.2903/j.efsa.2017.4699.

4

EFSA Journal

---

ANNEX

In the Annex to Regulation (EU) No 231/2012, the entry for food additive E 460(i) microcrystalline cellulose as regards its solubility is replaced by the following:

| ‘Solubility | Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution (concentration: 50 g NaOH/L).’ |
| --- | --- |

‘Solubility

Insoluble in water, ethanol, ether and dilute mineral acids. Practically insoluble or insoluble in sodium hydroxide solution (concentration: 50 g NaOH/L).’

---

Corrigenda

| 18.1.2018 | EN | Official Journal of the European Union | L 13/27 |
| --- | --- | --- | --- |

18.1.2018

EN

Official Journal of the European Union

L 13/27

---

Corrigendum to Definitive adoption (EU, Euratom) 2017/30 of amending budget No 5 of the European Union for the financial year 2017

(
  Official Journal of the European Union L 9 of 12 January 2018
  )

In the Contents page and on page 1 in the title:

for:

‘2017/30’,

read:

‘2018/30’.

---