# Official Journal L 181/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 181 |
| | |
| English edition | Legislation | Volume 589 July 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 181

English edition

Legislation

Volume 589 July 2015

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2015/1100 of 7 July 2015 on the reporting obligations of the Member States in the framework of rail market monitoring (
  1
  ) | 1 |
| | * | Commission Regulation (EU) 2015/1101 of 8 July 2015 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 difenoconazole, fluopicolide, fluopyram, isopyrazam and pendimethalin in or on certain products (
  1
  ) | 27 |
| | * | Commission Regulation (EU) 2015/1102 of 8 July 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (
  1
  ) | 54 |
| | * | Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species (
  1
  ) | 57 |
| | * | Commission Implementing Regulation (EU) 2015/1104 of 8 July 2015 amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours) (
  1
  ) | 61 |
| | * | Commission Implementing Regulation (EU) 2015/1105 of 8 July 2015 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH) (
  1
  ) | 65 |
| | * | Commission Implementing Regulation (EU) 2015/1106 of 8 July 2015 amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam (
  1
  ) | 70 |
| | * | Commission Implementing Regulation (EU) 2015/1107 of 8 July 2015 approving the basic substance Salix spp. cortex, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 72 |
| | * | Commission Implementing Regulation (EU) 2015/1108 of 8 July 2015 approving the basic substance vinegar in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 75 |
| | | Commission Implementing Regulation (EU) 2015/1109 of 8 July 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 78 |
| | | Commission Implementing Regulation (EU) 2015/1110 of 8 July 2015 establishing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 26 June to 3 July 2015 in the context of the tariff quota for maize opened by Regulation (EC) No 969/2006 | 80 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2015/1111 of 7 July 2015 on the compliance of the joint proposal submitted by the Member States concerned for the extension of the North Sea-Baltic rail freight corridor with Article 5 of Regulation (EU) No 913/2010 of the European Parliament and of the Council concerning a European rail network for competitive freight
  (notified under document C(2015) 4507) | 82 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2015/1100 of 7 July 2015 on the reporting obligations of the Member States in the framework of rail market monitoring (
  1
  )

1

1

*

Commission Regulation (EU) 2015/1101 of 8 July 2015 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 difenoconazole, fluopicolide, fluopyram, isopyrazam and pendimethalin in or on certain products (
  1
  )

1

27

*

Commission Regulation (EU) 2015/1102 of 8 July 2015 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances (
  1
  )

1

54

*

Commission Implementing Regulation (EU) 2015/1103 of 8 July 2015 concerning the authorisation of beta-carotene as a feed additive for all animal species (
  1
  )

1

57

*

Commission Implementing Regulation (EU) 2015/1104 of 8 July 2015 amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours) (
  1
  )

Saccharomyces cerevisiae

Aspergillus niger

1

61

*

Commission Implementing Regulation (EU) 2015/1105 of 8 July 2015 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH) (
  1
  )

Bifidobacterium animalis

animalis

Lactobacillus salivarius

. salivarius

Enterococcus faecium

1

65

*

Commission Implementing Regulation (EU) 2015/1106 of 8 July 2015 amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam (
  1
  )

1

70

*

Commission Implementing Regulation (EU) 2015/1107 of 8 July 2015 approving the basic substance Salix spp. cortex, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

Salix

1

72

*

Commission Implementing Regulation (EU) 2015/1108 of 8 July 2015 approving the basic substance vinegar in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

75

Commission Implementing Regulation (EU) 2015/1109 of 8 July 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

78

Commission Implementing Regulation (EU) 2015/1110 of 8 July 2015 establishing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 26 June to 3 July 2015 in the context of the tariff quota for maize opened by Regulation (EC) No 969/2006

80

DECISIONS

*

Commission Implementing Decision (EU) 2015/1111 of 7 July 2015 on the compliance of the joint proposal submitted by the Member States concerned for the extension of the North Sea-Baltic rail freight corridor with Article 5 of Regulation (EU) No 913/2010 of the European Parliament and of the Council concerning a European rail network for competitive freight
  (notified under document C(2015) 4507)

(notified under document C(2015) 4507)

82

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses ( OJ L 82, 22.3.2001 ) | 84 |

Corrigenda

*

Corrigendum to Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses ( OJ L 82, 22.3.2001 )

( OJ L 82, 22.3.2001 )

84

| | |
| --- | --- |
| | (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.

---

II Non-legislative acts

REGULATIONS

| 9.7.2015 | EN | Official Journal of the European Union | L 181/1 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1100

of 7 July 2015

on the reporting obligations of the Member States in the framework of rail market monitoring

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (1), and in particular Article 15(6) thereof,

Whereas:

| (1) | For the purposes of rail market monitoring, Article 15(5) of Directive 2012/34/EU imposes a reporting obligation on the Member States regarding the use of networks and the evolution of framework conditions in the rail sector. |
| --- | --- |

(1)

For the purposes of rail market monitoring, Article 15(5) of Directive 2012/34/EU imposes a reporting obligation on the Member States regarding the use of networks and the evolution of framework conditions in the rail sector.

| (2) | On the basis of the information submitted by the Member States, the Commission should report to the European Parliament and the Council every two years on the subjects referred to in Article 15(4) of Directive 2012/34/EU. |
| --- | --- |

(2)

On the basis of the information submitted by the Member States, the Commission should report to the European Parliament and the Council every two years on the subjects referred to in Article 15(4) of Directive 2012/34/EU.

| (3) | Member States had already been providing the Commission with the necessary information on a voluntary basis for a number of years. In order to ensure consistency and comparability between the data submitted by the Member States, detailed rules on the content and format of those data are necessary. |
| --- | --- |

(3)

Member States had already been providing the Commission with the necessary information on a voluntary basis for a number of years. In order to ensure consistency and comparability between the data submitted by the Member States, detailed rules on the content and format of those data are necessary.

| (4) | This Regulation sets up a questionnaire to be filled annually by the Member States for the purpose of monitoring the technical and economic conditions and market developments in the Union rail transport sector. |
| --- | --- |

(4)

This Regulation sets up a questionnaire to be filled annually by the Member States for the purpose of monitoring the technical and economic conditions and market developments in the Union rail transport sector.

| (5) | To compile the data required in the questionnaire, Member States should cooperate with social partners, users, regulatory bodies and other relevant competent authorities at national level. |
| --- | --- |

(5)

To compile the data required in the questionnaire, Member States should cooperate with social partners, users, regulatory bodies and other relevant competent authorities at national level.

| (6) | When deciding on the content of the data to be submitted by the questionnaire, the Commission takes into account existing data sources and data already provided under current reporting obligations in order to minimise the additional burden to rail industry and Member States. In particular, the Commission, where possible, makes use of data reported under following legal acts:






  — | Regulation (EEC) No 1108/70 of the Council (2), as regards the data on investments in railway infrastructure, |
| --- | --- | --- |

(6)

When deciding on the content of the data to be submitted by the questionnaire, the Commission takes into account existing data sources and data already provided under current reporting obligations in order to minimise the additional burden to rail industry and Member States. In particular, the Commission, where possible, makes use of data reported under following legal acts:

—

Regulation (EEC) No 1108/70 of the Council (2), as regards the data on investments in railway infrastructure,

| — | Regulation (EC) No 91/2003 of the European Parliament and of the Council (3), as regards the data on traffic volumes on the rail network, and the data on accidents, |
| --- | --- |

—

Regulation (EC) No 91/2003 of the European Parliament and of the Council (3), as regards the data on traffic volumes on the rail network, and the data on accidents,

| — | Commission Regulation (EC) No 1708/2005 (4), in particular its Annexes I and II, as regards the data on passenger rail transport, |
| --- | --- |

—

Commission Regulation (EC) No 1708/2005 (4), in particular its Annexes I and II, as regards the data on passenger rail transport,

| — | Regulation (EC) No 1371/2007 of the European Parliament and of the Council (5), as regards annual reports to be published by railway undertakings on service quality performance, and |
| --- | --- |

—

Regulation (EC) No 1371/2007 of the European Parliament and of the Council (5), as regards annual reports to be published by railway undertakings on service quality performance, and

| — | Commission Regulation (EU) No 1300/2014 (6), as regards the inventories of assets to be established by Member States for monitoring and evaluation the accessibility of Union's rail system for persons with disabilities and reduced mobility. |
| --- | --- |

—

Commission Regulation (EU) No 1300/2014 (6), as regards the inventories of assets to be established by Member States for monitoring and evaluation the accessibility of Union's rail system for persons with disabilities and reduced mobility.

| (7) | The European Network of Rail Regulatory Bodies should be closely involved in the implementation of the reporting obligations under Article 15 of Directive 2012/34/EU as well as in updating the methodology for data collection. |
| --- | --- |

(7)

The European Network of Rail Regulatory Bodies should be closely involved in the implementation of the reporting obligations under Article 15 of Directive 2012/34/EU as well as in updating the methodology for data collection.

| (8) | The questionnaire included in the Annex should be used to collect data as of the reporting year 2015. For the first two years of reporting, a transitional period is necessary, given that Member States may need to adjust existing data collection mechanisms following the entry into force of this Regulation. In order to avoid misinterpretation, it is important that during the transitional period Member States inform the Commission about the differences in the data content or format in the relevant sections of the questionnaire. |
| --- | --- |

(8)

The questionnaire included in the Annex should be used to collect data as of the reporting year 2015. For the first two years of reporting, a transitional period is necessary, given that Member States may need to adjust existing data collection mechanisms following the entry into force of this Regulation. In order to avoid misinterpretation, it is important that during the transitional period Member States inform the Commission about the differences in the data content or format in the relevant sections of the questionnaire.

| (9) | Upon request of the railway undertaking concerned, and if justified by the need for commercial confidentiality, Member States may submit to the Commission the data requested in point 7 of the questionnaire in pseudonymous form. |
| --- | --- |

(9)

Upon request of the railway undertaking concerned, and if justified by the need for commercial confidentiality, Member States may submit to the Commission the data requested in point 7 of the questionnaire in pseudonymous form.

| (10) | Data collected under this Regulation should be made available to all interested parties, except where the need to protect commercial confidentiality precludes this. |
| --- | --- |

(10)

Data collected under this Regulation should be made available to all interested parties, except where the need to protect commercial confidentiality precludes this.

| (11) | Methodologies, definitions and methods of collecting data may evolve over the time as a result of technical and scientific progress. Similarly, developments in the rail market and improvements in data availability may make it desirable to either reduce or extend the scope of the questionnaire. The Annex to this Regulation should therefore be updated regularly, in order to take account of these developments in accordance with the examination procedure referred to in Article 62(3) of Directive 2012/34/EU. |
| --- | --- |

(11)

Methodologies, definitions and methods of collecting data may evolve over the time as a result of technical and scientific progress. Similarly, developments in the rail market and improvements in data availability may make it desirable to either reduce or extend the scope of the questionnaire. The Annex to this Regulation should therefore be updated regularly, in order to take account of these developments in accordance with the examination procedure referred to in Article 62(3) of Directive 2012/34/EU.

| (12) | The Commission has consulted the railway sector's social partners and users through the Rail Market Monitoring Working Group. It has also consulted the European Network of Rail Regulatory Bodies. |
| --- | --- |

(12)

The Commission has consulted the railway sector's social partners and users through the Rail Market Monitoring Working Group. It has also consulted the European Network of Rail Regulatory Bodies.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 62(1) of Directive 2012/34/EU, |
| --- | --- |

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 62(1) of Directive 2012/34/EU,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation establishes content and format of the data to be submitted to the Commission by the Member States under their reporting obligations for rail market monitoring purposes.

Article 2

Definitions

For the purposes of this Regulation the definitions provided for in Article 2(e) of Regulation (EC) No 1370/2007 of the European Parliament and of the Council (7), Article 2(2)(a) of Regulation (EU) No 913/2010 of the European Parliament and of the Council (8) and Article 3 of Directive 2012/34/EU shall apply.

The following definitions shall also apply:

| (a) | ‘track access charges’ (TACs) means charges collected for the minimum access package referred to in point 1 of Annex II to Directive 2012/34/EU; |
| --- | --- |

(a)

‘track access charges’ (TACs) means charges collected for the minimum access package referred to in point 1 of Annex II to Directive 2012/34/EU;

| (b) | ‘high-speed services’ means rail passenger services provided by high-speed rolling stock, including tilting trains, that travel at least 200 km/h for at least part of the service; the use of high-speed infrastructure is not always necessary; |
| --- | --- |

(b)

‘high-speed services’ means rail passenger services provided by high-speed rolling stock, including tilting trains, that travel at least 200 km/h for at least part of the service; the use of high-speed infrastructure is not always necessary;

| (c) | ‘conventional long-distance services’ means rail passenger transport services other than urban, suburban, regional or high-speed services; |
| --- | --- |

(c)

‘conventional long-distance services’ means rail passenger transport services other than urban, suburban, regional or high-speed services;

| (d) | ‘station’ means a location on a railway where a passenger train service can start, stop or end; |
| --- | --- |

(d)

‘station’ means a location on a railway where a passenger train service can start, stop or end;

| (e) | ‘freight terminal’ means a place equipped for the transhipment and storage of intermodal transport units, where at least one of the modes of transport is rail; |
| --- | --- |

(e)

‘freight terminal’ means a place equipped for the transhipment and storage of intermodal transport units, where at least one of the modes of transport is rail;

| (f) | ‘total compensation from the state’ in the context of contractual agreements means the total amount which the state has agreed to pay to the infrastructure manager as funding over the entire contractual period; |
| --- | --- |

(f)

‘total compensation from the state’ in the context of contractual agreements means the total amount which the state has agreed to pay to the infrastructure manager as funding over the entire contractual period;

| (g) | ‘monitoring body’ means a body that, according to national legislation, verifies the infrastructure manager's compliance with the contractual agreement; |
| --- | --- |

(g)

‘monitoring body’ means a body that, according to national legislation, verifies the infrastructure manager's compliance with the contractual agreement;

| (h) | ‘track’ means a pair of rails over which rail-borne vehicles can travel; |
| --- | --- |

(h)

‘track’ means a pair of rails over which rail-borne vehicles can travel;

| (i) | ‘dedicated high-speed line’ means a line specially built to allow traffic to travel at speeds generally equal to or greater than 250 km/h on its main segments; it may include connecting segments where speeds are reduced to take account of local conditions; |
| --- | --- |

(i)

‘dedicated high-speed line’ means a line specially built to allow traffic to travel at speeds generally equal to or greater than 250 km/h on its main segments; it may include connecting segments where speeds are reduced to take account of local conditions;

| (j) | ‘node’ means an important point on the rail network where multiple railway lines are interconnected; |
| --- | --- |

(j)

‘node’ means an important point on the rail network where multiple railway lines are interconnected;

| (k) | ‘international passenger service’ means a passenger service where the train crosses at least one border of a Member State and where the service carries passengers between stations located in different states; |
| --- | --- |

(k)

‘international passenger service’ means a passenger service where the train crosses at least one border of a Member State and where the service carries passengers between stations located in different states;

| (l) | ‘domestic passenger service’ means a passenger service operated exclusively within the borders of one Member State; |
| --- | --- |

(l)

‘domestic passenger service’ means a passenger service operated exclusively within the borders of one Member State;

| (m) | ‘domestic freight service’ means a freight service operated exclusively within the borders of one Member State; |
| --- | --- |

(m)

‘domestic freight service’ means a freight service operated exclusively within the borders of one Member State;

| (n) | ‘path allocation’ means a decision on the allocation of individual train path(s) for operations; path allocation for each train service operating as part of a scheduled regular service counts as a separate path allocation; |
| --- | --- |

(n)

‘path allocation’ means a decision on the allocation of individual train path(s) for operations; path allocation for each train service operating as part of a scheduled regular service counts as a separate path allocation;

| (o) | ‘scheduled train path’, means a path allocated according to scheduling rules provided for in Article 45 of Directive 2012/34/EU; |
| --- | --- |

(o)

‘scheduled train path’, means a path allocated according to scheduling rules provided for in Article 45 of Directive 2012/34/EU;

| (p) | ‘ad hoc train path’ means a path allocated according to path request as referred to in Article 48 of Directive 2012/34/EU; |
| --- | --- |

(p)

‘ad hoc train path’ means a path allocated according to path request as referred to in Article 48 of Directive 2012/34/EU;

| (q) | ‘rejected path allocation’ means a request for a path that is rejected by the infrastructure manager following the coordination process laid down in Article 46(1) of Directive 2012/34/EU; each cancellation of train service operating as part of a scheduled regular service counts as a rejected path allocation; |
| --- | --- |

(q)

‘rejected path allocation’ means a request for a path that is rejected by the infrastructure manager following the coordination process laid down in Article 46(1) of Directive 2012/34/EU; each cancellation of train service operating as part of a scheduled regular service counts as a rejected path allocation;

| (r) | ‘maintenance’ means non-capital expenditure that the infrastructure manager carries out in order to maintain the condition and capability of the existing infrastructure; |
| --- | --- |

(r)

‘maintenance’ means non-capital expenditure that the infrastructure manager carries out in order to maintain the condition and capability of the existing infrastructure;

| (s) | ‘renewals’ means capital expenditure on a major substitution work on the existing infrastructure which does not change its overall performance; |
| --- | --- |

(s)

‘renewals’ means capital expenditure on a major substitution work on the existing infrastructure which does not change its overall performance;

| (t) | ‘upgrades’ means capital expenditure on a major modification work of the infrastructure which improves its overall performance; |
| --- | --- |

(t)

‘upgrades’ means capital expenditure on a major modification work of the infrastructure which improves its overall performance;

| (u) | ‘new infrastructure’ means capital expenditure on the projects for construction of new infrastructure installations; |
| --- | --- |

(u)

‘new infrastructure’ means capital expenditure on the projects for construction of new infrastructure installations;

| (v) | ‘public funds’ in the context of infrastructure expenditure means funds sourced directly from public investments grants; |
| --- | --- |

(v)

‘public funds’ in the context of infrastructure expenditure means funds sourced directly from public investments grants;

| (w) | ‘own funds’ means funds from revenue earned by infrastructure managers or operators of service facilities through access charges and by other means; |
| --- | --- |

(w)

‘own funds’ means funds from revenue earned by infrastructure managers or operators of service facilities through access charges and by other means;

| (x) | ‘revenue’ means the total fees collected from the provision of rail transportation services during the reporting period; it excludes other income such as revenue from catering, station services and on-board services; |
| --- | --- |

(x)

‘revenue’ means the total fees collected from the provision of rail transportation services during the reporting period; it excludes other income such as revenue from catering, station services and on-board services;

| (y) | ‘transit’ means transport through a country between the place of loading/embarkation and the place of unloading/disembarkation, both being outside that country; |
| --- | --- |

(y)

‘transit’ means transport through a country between the place of loading/embarkation and the place of unloading/disembarkation, both being outside that country;

| (z) | ‘railway traffic on national territory’ means any movement of railway vehicles within the borders of one country irrespective of the country in which the vehicles are registered; |
| --- | --- |

(z)

‘railway traffic on national territory’ means any movement of railway vehicles within the borders of one country irrespective of the country in which the vehicles are registered;

| (aa) | ‘delay’ means the difference in time between the time specified in the timetable of a train and the actual time at which it passes a specific location on the train's route at which travelling data are captured; |
| --- | --- |

(aa)

‘delay’ means the difference in time between the time specified in the timetable of a train and the actual time at which it passes a specific location on the train's route at which travelling data are captured;

| (bb) | ‘cancelled service’ means a train cancelled in the operations phase due to rail-service related reasons, including missing a scheduled stop if a train is rerouted or replacing a rail service with a road service; |
| --- | --- |

(bb)

‘cancelled service’ means a train cancelled in the operations phase due to rail-service related reasons, including missing a scheduled stop if a train is rerouted or replacing a rail service with a road service;

| (cc) | ‘average timetable speed’ means the speed calculated by dividing the total length of a journey by the time the journey is expected to take according to the timetable; |
| --- | --- |

(cc)

‘average timetable speed’ means the speed calculated by dividing the total length of a journey by the time the journey is expected to take according to the timetable;

| (dd) | ‘public service obligation compensation’ or ‘PSO compensation’ means the financial benefits granted, during the reporting period, directly or indirectly by a competent authority from public funds for the operation of rail services under a public service obligation; |
| --- | --- |

(dd)

‘public service obligation compensation’ or ‘PSO compensation’ means the financial benefits granted, during the reporting period, directly or indirectly by a competent authority from public funds for the operation of rail services under a public service obligation;

| (ee) | ‘commercial services’ means all passenger services that do not fall within the scope of services provided under public service obligations; |
| --- | --- |

(ee)

‘commercial services’ means all passenger services that do not fall within the scope of services provided under public service obligations;

| (ff) | ‘principal railway undertaking’ means the largest undertaking in terms of passenger-km or tonne-km; |
| --- | --- |

(ff)

‘principal railway undertaking’ means the largest undertaking in terms of passenger-km or tonne-km;

| (gg) | ‘active licence’ means a licence granted to a railway undertaking that has started and not ceased operations within the periods fixed by the Member State in accordance with Article 24(4) of Directive 2012/34/EU; |
| --- | --- |

(gg)

‘active licence’ means a licence granted to a railway undertaking that has started and not ceased operations within the periods fixed by the Member State in accordance with Article 24(4) of Directive 2012/34/EU;

| (hh) | ‘passive licence’ means a licence granted to a railway undertaking that has not started or has ceased operations within the periods fixed by the Member State in accordance with Article 24(4) of Directive 2012/34/EU, and licences which have been suspended or revoked; |
| --- | --- |

(hh)

‘passive licence’ means a licence granted to a railway undertaking that has not started or has ceased operations within the periods fixed by the Member State in accordance with Article 24(4) of Directive 2012/34/EU, and licences which have been suspended or revoked;

| (ii) | ‘fee to obtain a licence’ means all fees charged by a licensing authority in respect of the processing of the application; |
| --- | --- |

(ii)

‘fee to obtain a licence’ means all fees charged by a licensing authority in respect of the processing of the application;

| (jj) | ‘time for obtaining a licence’ means the length of time between the date on which a complete application for a licence is submitted and the date of the final decision; |
| --- | --- |

(jj)

‘time for obtaining a licence’ means the length of time between the date on which a complete application for a licence is submitted and the date of the final decision;

| (kk) | ‘full time equivalents’ means total hours, including over-time, worked in a job over a year divided by the average number of hours worked per year in a full-time job; |
| --- | --- |

(kk)

‘full time equivalents’ means total hours, including over-time, worked in a job over a year divided by the average number of hours worked per year in a full-time job;

| (ll) | ‘marshalling yard’ means a site or a part of a site equipped with a number of tracks or other equipment used for railway vehicle marshalling operations, including switching. |
| --- | --- |

(ll)

‘marshalling yard’ means a site or a part of a site equipped with a number of tracks or other equipment used for railway vehicle marshalling operations, including switching.

Article 3

Data collection and submission

1.   By 31 December each year, Member States shall submit to the Commission the data specified in the questionnaire included in the Annex in respect of the preceding year.

2.   Each Member State shall submit to the Commission the data relating to rail transport on its territory.

3.   Where a railway undertaking operates in more than one Member State, it shall provide the national authorities with separate data for each Member State in which it operates.

4.   Member States may obtain the necessary data from a combination of the following sources:

| (a) | mandatory surveys; |
| --- | --- |

(a)

mandatory surveys;

| (b) | administrative data, including data collected by statistical offices and other authorities; |
| --- | --- |

(b)

administrative data, including data collected by statistical offices and other authorities;

| (c) | statistical estimations, while explaining methods used; |
| --- | --- |

(c)

statistical estimations, while explaining methods used;

| (d) | data supplied by relevant industry organisations or other concerned parties; and |
| --- | --- |

(d)

data supplied by relevant industry organisations or other concerned parties; and

| (e) | ad hoc studies. |
| --- | --- |

(e)

ad hoc studies.

The entities holding the relevant data shall provide it when requested.

5.   In order to help Member States ensure the quality and comparability of their data, the Commission may develop methodological guidance materials taking into account the best practices adopted by national authorities and professional organisations in the railway industry.

6.   Member States shall submit the data to the Commission using the electronic form of the questionnaire to be made available by the Commission on its website.

7.   Member States and the Commission shall respect the commercial confidentiality of information provided to them.

Article 4

Transitional provisions

1.   Member States shall ensure that their data collection arrangements allow the data to be reported according to the content and format defined in the Annex for the reporting year 2017 at the latest. Where Member States have identified substantial difficulties in the alignment of data collection arrangements or raised concerns about the relevance or necessity of certain data categories, the need for adjusting the Annex shall be assessed.

2.   Where, during the transitional period, Member States cannot provide the data according to the content and format as defined in the Annex, they shall report data in a closest available format and indicate discrepancies when submitting the data.

Article 5

Entry into force and application

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

It shall apply from 1 January 2016.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 7 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 343, 14.12.2012, p. 32.

1

(2)  Regulation (EEC) No 1108/70 of the Council of 4 June 1970 introducing an accounting system for expenditure on infrastructure in respect of transport by rail, road and inland waterway (OJ L 130, 15.6.1970, p. 4).

2

(3)  Regulation (EC) No 91/2003 of the European Parliament and of the Council of 16 December 2002 on rail transport statistics (OJ L 14, 21.1.2003, p. 1).

3

(4)  Commission Regulation (EC) No 1708/2005 of 19 October 2005 laying down detailed rules for the implementation of Council Regulation (EC) No 2494/95 as regards the common index reference period for the harmonised index of consumer prices, and amending Regulation (EC) No 2214/96 (OJ L 274, 20.10.2005, p. 9).

4

(5)  Regulation (EC) No 1371/2007 of the European Parliament and of the Council of 23 October 2007 on rail passengers' rights and obligations (OJ L 315, 3.12.2007, p. 14).

5

(6)  Commission Regulation (EU) No 1300/2014 of 18 November 2014 on the technical specifications for interoperability relating to accessibility of the Union's rail system for persons with disabilities and persons with reduced mobility (OJ L 356, 12.12.2014, p. 110).

6

(7)  Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70 (OJ L 315, 3.12.2007, p. 1).

7

(8)  Regulation (EU) No 913/2010 of the European Parliament and of the Council of 22 September 2010 concerning a European rail network for competitive freight (OJ L 276, 20.10.2010, p. 22).

8

---

ANNEX

RAIL MARKET MONITORING QUESTIONNAIRE

Background information

| Member State:

  ☐ BE ☐BG ☐ CZ ☐ DK ☐ DE ☐ EE ☐ IE ☐ EL ☐ ES ☐ FR ☐ HR ☐ IT ☐ CY ☐ LV ☐ LT ☐ LU ☐ HU ☐ MT ☐ NL ☐ AT ☐ PL ☐ PT ☐ RO ☐ SI ☐ SK ☐ FI ☐ SE ☐ UK
  ☐ NO

  Reporting period: ☐☐/☐☐/☐☐ — ☐☐/☐☐/☐☐
  Responsible authority:
  Contact email address: |
| --- |

Member State:

☐ BE ☐BG ☐ CZ ☐ DK ☐ DE ☐ EE ☐ IE ☐ EL ☐ ES ☐ FR ☐ HR ☐ IT ☐ CY ☐ LV ☐ LT ☐ LU ☐ HU ☐ MT ☐ NL ☐ AT ☐ PL ☐ PT ☐ RO ☐ SI ☐ SK ☐ FI ☐ SE ☐ UK

☐ NO

Reporting period: ☐☐/☐☐/☐☐ — ☐☐/☐☐/☐☐

Responsible authority:

Contact email address:

Member States whose national currency is not the euro should use the average exchange rate over the reporting period to convert monetary values from their currency into euros. The exchange rate used should be indicated below.

| 1 ☐☐☐ = ☐,☐☐☐☐ EUR |
| --- |

1 ☐☐☐ = ☐,☐☐☐☐ EUR

Questions marked with an asterisk (*) are optional.

Where the reporting obligations in this Annex refer to railway undertakings, they shall not apply to railway undertakings which only operate urban, suburban or regional services on local and regional stand-alone networks as referred to in Article 2(1) of Directive 2012/34/EU.

1.   Infrastructure charging

1.1.   Average track access charges (TACs) per train-km for different categories of train

The table should be filled in only for the categories of train in use in the reporting Member State. Where arithmetic averages cannot be calculated, an estimate of the TACs of different categories of train can be given. The method used to calculate or estimate the TACs should be explained in box 1.5 (1).

| Train category

  (only if in use in the reporting Member State) | Track access charge, excluding mark-ups

  (euros/train-km) |
| --- | --- |
| Passenger services: |
| Passenger train providing suburban and regional services | ☐☐☐,☐☐ |
| Passenger train providing conventional long-distance services | ☐☐☐,☐☐ |
| Passenger train providing high-speed services on dedicated high-speed lines | ☐☐☐,☐☐ |
| Freight services: |
| 1 000 gross tonne freight train | ☐☐☐,☐☐ |
| 1 600 gross tonne freight train | ☐☐☐,☐☐ |
| 6 000 gross tonne freight train | ☐☐☐,☐☐ |

Train category

(only if in use in the reporting Member State)

Track access charge, excluding mark-ups

(euros/train-km)

Passenger services:

Passenger train providing suburban and regional services

☐☐☐,☐☐

Passenger train providing conventional long-distance services

☐☐☐,☐☐

Passenger train providing high-speed services on dedicated high-speed lines

☐☐☐,☐☐

Freight services:

1 000 gross tonne freight train

☐☐☐,☐☐

1 600 gross tonne freight train

☐☐☐,☐☐

6 000 gross tonne freight train

☐☐☐,☐☐

1.2.   Infrastructure managers' revenue from infrastructure, station and terminal charges

Only charges collected by infrastructure managers need to be reported. These include charges collected for station facilities and freight terminals owned or managed by infrastructure managers.

| | Revenue

  (thousand euros) |
| --- | --- |
| Passenger services: |
| Total revenue from track access charges, including mark-ups | ☐☐☐☐☐☐☐☐☐ |
| Total revenue from station charges | ☐☐☐☐☐☐☐☐☐ |
| Of which: |
| Station charges for suburban and regional trains (*) | ☐☐☐☐☐☐☐☐☐ |
| Station charges for conventional long-distance and high-speed trains (*) | ☐☐☐☐☐☐☐☐☐ |
| Other charges collected from passenger train operators | ☐☐☐☐☐☐☐☐☐ |
| Freight services: |
| Total revenue from track access charges, including mark-ups | ☐☐☐☐☐☐☐☐☐ |
| Total revenue from freight terminal charges | ☐☐☐☐☐☐☐☐☐ |
| Other charges collected from freight train operators | ☐☐☐☐☐☐☐☐☐ |
| Total revenue collected by infrastructure managers | ☐☐☐☐☐☐☐☐☐ |

Revenue

(thousand euros)

Passenger services:

Total revenue from track access charges, including mark-ups

☐☐☐☐☐☐☐☐☐

Total revenue from station charges

☐☐☐☐☐☐☐☐☐

Of which:

Station charges for suburban and regional trains (*)

☐☐☐☐☐☐☐☐☐

Station charges for conventional long-distance and high-speed trains (*)

☐☐☐☐☐☐☐☐☐

Other charges collected from passenger train operators

☐☐☐☐☐☐☐☐☐

Freight services:

Total revenue from track access charges, including mark-ups

☐☐☐☐☐☐☐☐☐

Total revenue from freight terminal charges

☐☐☐☐☐☐☐☐☐

Other charges collected from freight train operators

☐☐☐☐☐☐☐☐☐

Total revenue collected by infrastructure managers

☐☐☐☐☐☐☐☐☐

1.3.   Main characteristics of the contractual agreements concluded pursuant to Article 30(2) of Directive 2012/34/EU

| Infrastructure manager

  (name) | Length of the network covered

  (km) | Start date | End date | Have performance indicators been agreed? (2)

  If yes, please specify | Total compensation from the state (thousand euros) | Existence of monitoring body of the contract?
  If yes, please specify

  (name) |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | ☐ YES ☐ NO | | ☐☐☐☐☐☐ | ☐ YES ☐ NO | |
| | | | | ☐ YES ☐ NO | | ☐☐☐☐☐☐ | ☐ YES ☐ NO | |
| | | | | ☐ YES ☐ NO | | ☐☐☐☐☐☐ | ☐ YES ☐ NO | |
| | | | | ☐ YES ☐ NO | | ☐☐☐☐☐☐ | ☐ YES ☐ NO | |
| | | | | ☐ YES ☐ NO | | ☐☐☐☐☐☐ | ☐ YES ☐ NO | |

Infrastructure manager

(name)

Length of the network covered

(km)

Start date

End date

Have performance indicators been agreed? (2)

If yes, please specify

Total compensation from the state (thousand euros)

Existence of monitoring body of the contract?

If yes, please specify

(name)

☐ YES ☐ NO

☐☐☐☐☐☐

☐ YES ☐ NO

☐ YES ☐ NO

☐☐☐☐☐☐

☐ YES ☐ NO

☐ YES ☐ NO

☐☐☐☐☐☐

☐ YES ☐ NO

☐ YES ☐ NO

☐☐☐☐☐☐

☐ YES ☐ NO

☐ YES ☐ NO

☐☐☐☐☐☐

☐ YES ☐ NO

1.4.   Noise abatement

Are there mandatory rules (either in force or to be introduced) obliging rail operators and/or infrastructure managers to take measures to reduce the exposure of the population to rail noise? These measures could include limits on volumes of traffic, noise barriers or noise differentiated TACs aiming to accelerate the retrofitting of freight wagons with ‘silent’ brake blocks.

☐ YES ☐ NO

| If yes, please specify: |
| --- |

If yes, please specify:

1.5.   Additional comments (*):

Please add any further comments on the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Explain how the average TACs per train-km in Table 1.1 have been calculated, including which components of the charges are included. |
| --- | --- |

—

Explain how the average TACs per train-km in Table 1.1 have been calculated, including which components of the charges are included.

| — | Specify whether mark-ups are applied on top of the reported TACs. |
| --- | --- |

—

Specify whether mark-ups are applied on top of the reported TACs.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Indicate whether ERTMS (3) differentiated TACs have been applied. |
| --- | --- |

—

Indicate whether ERTMS (3) differentiated TACs have been applied.

| |
| --- |

2.   Capacity allocation

2.1.   Congested sections of the infrastructure

Please provide the following information relating to congested sections, as defined in Article 47(1) of Directive 2012/34/EU, in respect of the situation at the end of the reporting period.

| Total length of tracks affected by congestion (km) | ☐☐☐☐☐☐ |
| --- | --- |
| Of which: |
| Dedicated high-speed lines (km) | ☐☐☐☐☐☐ |
| Rail freight corridors (km) | ☐☐☐☐☐☐ |
| |
| Number of congested nodes | ☐☐☐ |

Total length of tracks affected by congestion (km)

☐☐☐☐☐☐

Of which:

Dedicated high-speed lines (km)

☐☐☐☐☐☐

Rail freight corridors (km)

☐☐☐☐☐☐

Number of congested nodes

☐☐☐

2.2.   Priority services

Please give the ranking (1 meaning the highest priority) of the rail services when the reporting Member State has to prioritise for allocating infrastructure capacity, e.g. within the scheduling and coordination process and in the events of temporary capacity limitations or disturbance. If any of the listed services is not eligible to priority rules, please put a cross (‘x’) in the box.

| ☐ | Services provided under public service obligations (PSOs) |
| --- | --- |

☐

Services provided under public service obligations (PSOs)

| ☐ | Domestic high-speed services |
| --- | --- |

☐

Domestic high-speed services

| ☐ | Other domestic passenger services |
| --- | --- |

☐

Other domestic passenger services

| ☐ | International passenger services |
| --- | --- |

☐

International passenger services

| ☐ | Domestic freight services |
| --- | --- |

☐

Domestic freight services

| ☐ | International freight services |
| --- | --- |

☐

International freight services

| ☐ | Other |
| --- | --- |

☐

Other

Please specify:

2.3.   Successful and rejected path allocations for various services

The table should be filled in only for the categories of train in use in the reporting Member State. Please provide the following information relating to the situation after the scheduling and coordination processes set out in Articles 45 and 46 of Directive 2012/34/EU.

| Service | Scheduled train paths | Ad hoc train paths |
| --- | --- | --- |
| Successful path allocations

  (number) | Rejected path allocations

  (number) | Successful path allocations

  (number) | Rejected path allocations

  (number) |
| Total passenger services: | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Domestic suburban and regional | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Domestic conventional long-distance | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Domestic high-speed | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| International | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Total freight services: | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Domestic freight | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| International freight | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Of which: |
| Paths allocated by one-stop shops of rail freight corridors | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |

Service

Scheduled train paths

Ad hoc train paths

Successful path allocations

(number)

Rejected path allocations

(number)

Successful path allocations

(number)

Rejected path allocations

(number)

Total passenger services:

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Domestic suburban and regional

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Domestic conventional long-distance

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Domestic high-speed

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

International

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Total freight services:

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Domestic freight

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

International freight

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Of which:

Paths allocated by one-stop shops of rail freight corridors

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

2.4.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Provide a brief description of the priority criteria used by the infrastructure managers for path allocations in relation to the circumstances in which these criteria are applied, e.g. within the scheduling and coordination process and in the event of temporary capacity limitation or disturbance. |
| --- | --- |

—

Provide a brief description of the priority criteria used by the infrastructure managers for path allocations in relation to the circumstances in which these criteria are applied, e.g. within the scheduling and coordination process and in the event of temporary capacity limitation or disturbance.

| — | Specify whether scarcity charging, as provided for in Article 31(4) of Directive 2012/34/EU, has been used. |
| --- | --- |

—

Specify whether scarcity charging, as provided for in Article 31(4) of Directive 2012/34/EU, has been used.

| — | Specify whether capacity enhancement plans, as provided for in Article 51 of Directive 2012/34/EU, have been prepared and implemented. |
| --- | --- |

—

Specify whether capacity enhancement plans, as provided for in Article 51 of Directive 2012/34/EU, have been prepared and implemented.

| |
| --- |

3.   Expenditure on infrastructure

Please indicate the expenditure incurred during the reporting period by the main railway infrastructure managers and by other owners of stations and freight terminals. In fragmented markets, the scope of reporting can be limited to the expenditure of the owners of main stations and freight terminals (4). For intra-modal stations and terminals, include only the part of the expenditure relating to rail transport.

3.1.   Overview of expenditure on railway infrastructure

| (thousand EUR) |
| --- |
| | Maintenance | Renewals | Upgrades | New infrastructure |
| Conventional lines | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Dedicated high-speed lines | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Major stations | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Major freight terminals | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Total expenditure | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |

(thousand EUR)

Maintenance

Renewals

Upgrades

New infrastructure

Conventional lines

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Dedicated high-speed lines

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Major stations

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Major freight terminals

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Total expenditure

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

3.2.   Source of funding for expenditure on different components of infrastructure
   (5)

| (thousand EUR) |
| --- |
| | Public funds | EU funds | Own funds |
| Existing infrastructure, including major stations and freight terminals | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| New infrastructure |
| Conventional and dedicated high-speed lines | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Major stations | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Major freight terminals | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Total expenditure | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |

(thousand EUR)

Public funds

EU funds

Own funds

Existing infrastructure, including major stations and freight terminals

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

New infrastructure

Conventional and dedicated high-speed lines

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Major stations

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Major freight terminals

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Total expenditure

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

3.3.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Make reference to the national infrastructure development strategy published pursuant to Article 8(1) of Directive 2012/34/EU. |
| --- | --- |

—

Make reference to the national infrastructure development strategy published pursuant to Article 8(1) of Directive 2012/34/EU.

| |
| --- |

4.   Revenue and traffic volumes

4.1.   Revenue and volumes of passenger and freight services

To ensure that the volume of services and reported revenue correspond, only revenue generated from railway traffic on a country's national territory should be reported in this table. Statistical estimations can be used, if necessary. If official statistics on traffic volumes are not yet available, preliminary values can be given, and then adjusted at a later date.

| Passenger services: |
| --- |
| Total revenue of railway undertakings from transport services (thousand euros) | ☐☐☐☐☐☐☐☐☐ |
| Total volume of services (thousand train-km) | ☐☐☐☐☐☐,☐ |
| Total volume of services (million passenger-km) | ☐☐☐☐☐☐,☐ |
| Volume of domestic services (million passenger-km) | ☐☐☐☐☐☐,☐ |
| Volume of international services (million passenger-km) | ☐☐☐☐☐☐,☐ |
| Volume of transit services (*) (million passenger-km) | ☐☐☐☐☐☐,☐ |
| Revenue from and volumes of PSO and commercial services |
| PSO services: |
| Revenue from fares (thousand euros) | ☐☐☐☐☐☐☐☐☐ |
| PSO compensation (thousand euros)
   (6) | ☐☐☐☐☐☐☐☐☐ |
| Volume of services (million passenger-km)
   (7) | ☐☐☐☐☐☐,☐ |
| Commercial services: |
| Revenue from fares (thousand euros) | ☐☐☐☐☐☐☐☐☐ |
| Volume of services (million passenger-km) | ☐☐☐☐☐☐,☐ |
| Freight services: |
| Total revenue of railway undertakings from transport services (thousand euros) | ☐☐☐☐☐☐☐☐☐ |
| Total volume of services (thousand train-km) | ☐☐☐☐☐☐,☐ |
| Total volume of services (million tonne-km) | ☐☐☐☐☐☐,☐ |
| Volume of domestic services (million tonne-km) | ☐☐☐☐☐☐,☐ |
| Volume of international services (million tonne-km) | ☐☐☐☐☐☐,☐ |
| Volume of transit services (*) (million tonne-km) | ☐☐☐☐☐☐,☐ |

Passenger services:

Total revenue of railway undertakings from transport services (thousand euros)

☐☐☐☐☐☐☐☐☐

Total volume of services (thousand train-km)

☐☐☐☐☐☐,☐

Total volume of services (million passenger-km)

☐☐☐☐☐☐,☐

Volume of domestic services (million passenger-km)

☐☐☐☐☐☐,☐

Volume of international services (million passenger-km)

☐☐☐☐☐☐,☐

Volume of transit services (*) (million passenger-km)

☐☐☐☐☐☐,☐

Revenue from and volumes of PSO and commercial services

PSO services:

Revenue from fares (thousand euros)

☐☐☐☐☐☐☐☐☐

PSO compensation (thousand euros)
   (6)

☐☐☐☐☐☐☐☐☐

Volume of services (million passenger-km)
   (7)

☐☐☐☐☐☐,☐

Commercial services:

Revenue from fares (thousand euros)

☐☐☐☐☐☐☐☐☐

Volume of services (million passenger-km)

☐☐☐☐☐☐,☐

Freight services:

Total revenue of railway undertakings from transport services (thousand euros)

☐☐☐☐☐☐☐☐☐

Total volume of services (thousand train-km)

☐☐☐☐☐☐,☐

Total volume of services (million tonne-km)

☐☐☐☐☐☐,☐

Volume of domestic services (million tonne-km)

☐☐☐☐☐☐,☐

Volume of international services (million tonne-km)

☐☐☐☐☐☐,☐

Volume of transit services (*) (million tonne-km)

☐☐☐☐☐☐,☐

4.2.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | State whether the values provided for revenue generated from railway traffic on national territory are reported figures or estimates. Where sampling or estimates have been used, explain briefly the approach taken. |
| --- | --- |

—

State whether the values provided for revenue generated from railway traffic on national territory are reported figures or estimates. Where sampling or estimates have been used, explain briefly the approach taken.

| — | Specify whether there were any gaps or inconsistencies in the input data. |
| --- | --- |

—

Specify whether there were any gaps or inconsistencies in the input data.

| |
| --- |

5.   Quality of rail services

The tables should be filled in only for the categories of train in use in the reporting Member State.

5.1.   Punctuality and cancellations of passenger services

| Passenger services: | Total number of services | Number of trains arriving on time
  (delay of 5 minutes or less) | Number of services cancelled |
| --- | --- | --- | --- |
| Suburban and regional services | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| Conventional long-distance and high-speed services | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |

Passenger services:

Total number of services

Number of trains arriving on time

(delay of 5 minutes or less)

Number of services cancelled

Suburban and regional services

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

Conventional long-distance and high-speed services

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

5.2.   Punctuality and cancellations of freight services
   (8)

| Freight services: | Total number of services | Number of trains arriving on time
  (delay of 15 minutes or less) | Number of services cancelled |
| --- | --- | --- | --- |
| Domestic services | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |
| International services | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ | ☐☐☐☐☐☐☐☐☐ |

Freight services:

Total number of services

Number of trains arriving on time

(delay of 15 minutes or less)

Number of services cancelled

Domestic services

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

International services

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

☐☐☐☐☐☐☐☐☐

5.3.   Average timetable speed of freight services (*)

| Freight services: | Average timetable speed (km/h) |
| --- | --- |
| Domestic services | ☐☐☐ |
| International services | ☐☐☐ |

Freight services:

Average timetable speed (km/h)

Domestic services

☐☐☐

International services

☐☐☐

5.4.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Explain how the ‘delay’ of a train has been measured (e.g. only at the final stop or as an average over all scheduled stops). |
| --- | --- |

—

Explain how the ‘delay’ of a train has been measured (e.g. only at the final stop or as an average over all scheduled stops).

| — | Provide references for performance reports and satisfaction surveys published by the rail freight corridor management board pursuant to Article 19 of Regulation (EU) No 913/2010 of the European Parliament and of the Council (9). |
| --- | --- |

—

Provide references for performance reports and satisfaction surveys published by the rail freight corridor management board pursuant to Article 19 of Regulation (EU) No 913/2010 of the European Parliament and of the Council (9).

| — | Provide reference for any other surveys on the quality of freight and passenger services that have been conducted recently. |
| --- | --- |

—

Provide reference for any other surveys on the quality of freight and passenger services that have been conducted recently.

| |
| --- |

6.   Public service obligations (PSOs)

6.1.   Volume of services and compensation paid for services provided under PSOs in different market segments

The table should be filled in only for the categories of train in use in the reporting Member State.

| | Volume of services

  (million passenger-km) | Volume of services (thousand train-km) | PSO compensation (10)
  (thousand euros) |
| --- | --- | --- | --- |
| Total | Of which: |
| Competitively tendered | Directly awarded |
| Total PSO services | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐☐☐☐ |
| Of which: |
| Suburban and regional | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐☐☐☐ |
| Conventional long-distance | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐☐☐☐ |
| High-speed | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐☐☐☐ |
| Of which: |
| International services provided under PSOs | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐,☐ | ☐☐☐☐☐☐☐☐☐ |

Volume of services

(million passenger-km)

Volume of services (thousand train-km)

PSO compensation (10)
  (thousand euros)

Total

Of which:

Competitively tendered

Directly awarded

Total PSO services

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐☐☐☐

Of which:

Suburban and regional

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐☐☐☐

Conventional long-distance

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐☐☐☐

High-speed

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐☐☐☐

Of which:

International services provided under PSOs

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐,☐

☐☐☐☐☐☐☐☐☐

6.2.   Access to rolling stock in the context of PSO services

Please provide the following information relating to each PSO contract awarded during the reporting period.

| | Description (regions or lines covered) | Duration (years) | Volume of contract (thousand train-km/year) | Operator (name) | Was the contract been competitively tendered? | Arrangements for rolling stock provision |
| --- | --- | --- | --- | --- | --- | --- |
| Defined in the tender specification? | Description (11) |
| 1. | | | | | ☐ YES ☐ NO | ☐ YES ☐ NO | |
| 2. | | | | | ☐ YES ☐ NO | ☐ YES ☐ NO | |
| 3. | | | | | ☐ YES ☐ NO | ☐ YES ☐ NO | |
| ... | | | | | ☐ YES ☐ NO | ☐ YES ☐ NO | |

Description (regions or lines covered)

Duration (years)

Volume of contract (thousand train-km/year)

Operator (name)

Was the contract been competitively tendered?

Arrangements for rolling stock provision

Defined in the tender specification?

Description (11)

1.

☐ YES ☐ NO

☐ YES ☐ NO

2.

☐ YES ☐ NO

☐ YES ☐ NO

3.

☐ YES ☐ NO

☐ YES ☐ NO

...

☐ YES ☐ NO

☐ YES ☐ NO

6.3.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| |
| --- |

7.   Degree of market opening

List the railway undertakings that have a market share of 1 % or more. Where there are more than ten undertakings with a market share of 1 % or more, only list the 10 largest. The market share held by other railway undertakings can be given as a total under ‘Others’.

If for the reasons of commercial confidentiality the name of a railway undertaking cannot be indicated, please use pseudonyms, e.g. ‘RU 1’, ‘RU 2’. If this would not be enough to resolve confidentiality issues, railway undertaking's market shares, except that of the principal or incumbent railway undertaking, can be further bundled.

7.1.   Passenger market — PSO services

| Railway undertaking

  (name or pseudonym) | Market share of PSO services

  (percentage)
   (12) |
| --- | --- |
| Principal or incumbent railway undertaking: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Other railway undertakings: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Others: | ☐☐☐,☐ % |

Railway undertaking

(name or pseudonym)

Market share of PSO services

(percentage)
   (12)

Principal or incumbent railway undertaking:

☐☐☐,☐ %

☐☐☐,☐ %

Other railway undertakings:

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

Others:

☐☐☐,☐ %

7.2.   Passenger market — commercial services

| Railway undertaking

  (name or pseudonym) | Market share of commercial services

  (percentage)
   (13) |
| --- | --- |
| Principal or incumbent railway undertaking: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Other railway undertakings: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Others: | ☐☐☐,☐ % |

Railway undertaking

(name or pseudonym)

Market share of commercial services

(percentage)
   (13)

Principal or incumbent railway undertaking:

☐☐☐,☐ %

☐☐☐,☐ %

Other railway undertakings:

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

Others:

☐☐☐,☐ %

7.3.   Freight market

| Railway undertaking

  (name or pseudonym) | Market share of freight services

  (percentage)
   (14) |
| --- | --- |
| Principal or incumbent railway undertaking: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Other railway undertakings: |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| | ☐☐☐,☐ % |
| Others: | ☐☐☐,☐ % |

Railway undertaking

(name or pseudonym)

Market share of freight services

(percentage)
   (14)

Principal or incumbent railway undertaking:

☐☐☐,☐ %

☐☐☐,☐ %

Other railway undertakings:

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

☐☐☐,☐ %

Others:

☐☐☐,☐ %

7.4.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Indicate whether any major new railway undertakings have entered the passenger or freight market during the reporting period. |
| --- | --- |

—

Indicate whether any major new railway undertakings have entered the passenger or freight market during the reporting period.

| |
| --- |

8.   Degree of harmonisation and legislative developments (*)

Information on the degree of legal harmonisation is already available to the Commission, as Member States notify the Commission when they have transposed the legislation.

This section allows Member States to comment on any outstanding issues relating to the EU rail market or the development of national laws on railways.

8.1.   Additional comments (*):

| |
| --- |

9.   Licensing

9.1.   Number of licences issued to railway undertakings
   (15)

| Number of active licences at the start of the reporting period (A) | ☐☐☐☐ |
| --- | --- |
| Number of licences suspended or revoked during the reporting period (16) (B) | ☐☐☐☐ |
| Number licences granted during the reporting period (C) | ☐☐☐☐ |
| Number of active licences at the end of the reporting period (A – B + C) | ☐☐☐☐ |
| |
| Number of passive licences at the end of the reporting period | ☐☐☐☐ |

Number of active licences at the start of the reporting period (A)

☐☐☐☐

Number of licences suspended or revoked during the reporting period (16) (B)

☐☐☐☐

Number licences granted during the reporting period (C)

☐☐☐☐

Number of active licences at the end of the reporting period (A – B + C)

☐☐☐☐

Number of passive licences at the end of the reporting period

☐☐☐☐

9.2.   Fees and time needed for obtaining a licence

| Average fee to obtain a licence (euros) | ☐☐☐☐☐☐ |
| --- | --- |
| Average time for obtaining a licence (calendar days) | ☐☐☐ |

Average fee to obtain a licence (euros)

☐☐☐☐☐☐

Average time for obtaining a licence (calendar days)

☐☐☐

9.3.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| |
| --- |

10.   Employment and social conditions

10.1.   Employees in the rail sector by gender and age group

Please provide the following information in respect of the situation at the end of the reporting period. Where any of the undertakings also provides services to sectors other than the railway sector, the number of employees can be stated based on an estimate of the proportion of the total employees involved in delivering rail-related services.

| | Total

  (full-time equivalents) | Men (%) | Women (%) | | < 30 years (%) | 30-50 years (%) | > 50 years (%) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Total staff of the incumbent or other main railway undertakings (17) | ☐☐☐☐☐☐ | ☐☐,☐ % | ☐☐,☐ % | | ☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % |
| Of which:

  train drivers | ☐☐☐☐☐☐ | ☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % |
| Total staff of other railway undertakings | ☐☐☐☐☐☐ | |
| Of which:

  train drivers | ☐☐☐☐☐☐ |
| Total staff of main infrastructure managers | ☐☐☐☐☐☐ | ☐☐,☐ % | ☐☐,☐ % | | ☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % |
| Total staff of other infrastructure managers | ☐☐☐☐☐☐ | |
| Staff of other companies providing services related to rail transport (*) (18) | ☐☐☐☐☐☐ |
| Of which: | |
| Stations (*) | ☐☐☐☐☐☐ | |
| Freight terminals (*) | ☐☐☐☐☐☐ |
| Rolling stock maintenance (*) | ☐☐☐☐☐☐ |
| Infrastructure maintenance (*) | ☐☐☐☐☐☐ |
| Specialised training organisations (*) | ☐☐☐☐☐☐ |
| Train driver leasing (*) | ☐☐☐☐☐☐ |
| Energy supply (*) | ☐☐☐☐☐☐ |
| Rolling stock cleaning services (*) | ☐☐☐☐☐☐ |
| Other (*) | ☐☐☐☐☐☐ |

Total

(full-time equivalents)

Men (%)

Women (%)

< 30 years (%)

30-50 years (%)

> 50 years (%)

Total staff of the incumbent or other main railway undertakings (17)

☐☐☐☐☐☐

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

Of which:

train drivers

☐☐☐☐☐☐

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

Total staff of other railway undertakings

☐☐☐☐☐☐

Of which:

train drivers

☐☐☐☐☐☐

Total staff of main infrastructure managers

☐☐☐☐☐☐

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

Total staff of other infrastructure managers

☐☐☐☐☐☐

Staff of other companies providing services related to rail transport (*) (18)

☐☐☐☐☐☐

Of which:

Stations (*)

☐☐☐☐☐☐

Freight terminals (*)

☐☐☐☐☐☐

Rolling stock maintenance (*)

☐☐☐☐☐☐

Infrastructure maintenance (*)

☐☐☐☐☐☐

Specialised training organisations (*)

☐☐☐☐☐☐

Train driver leasing (*)

☐☐☐☐☐☐

Energy supply (*)

☐☐☐☐☐☐

Rolling stock cleaning services (*)

☐☐☐☐☐☐

Other (*)

☐☐☐☐☐☐

10.2.   Employees by the type of contract

Please give the following information in respect of the situation at the end of the reporting period.

| | Permanent contracts
  A (19)


  (%) | Temporary contracts
  B

  (%) | | Part-time contracts

  (%) | Apprentices and trainees

  (%) |
| --- | --- | --- | --- | --- | --- |
| Total staff of the incumbent or other main railway undertakings (20) | ☐☐☐,☐ % | ☐☐☐,☐ % | | ☐☐,☐ % | ☐☐,☐ % |
| Of which:

  train drivers | ☐☐☐,☐ % | ☐☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % |
| Total staff of main infrastructure managers | ☐☐☐,☐ % | ☐☐☐,☐ % | ☐☐,☐ % | ☐☐,☐ % |

Permanent contracts

A (19)

(%)

Temporary contracts

B

(%)

Part-time contracts

(%)

Apprentices and trainees

(%)

Total staff of the incumbent or other main railway undertakings (20)

☐☐☐,☐ %

☐☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

Of which:

train drivers

☐☐☐,☐ %

☐☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

Total staff of main infrastructure managers

☐☐☐,☐ %

☐☐☐,☐ %

☐☐,☐ %

☐☐,☐ %

10.3.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Where sampling or estimations have been used to compile the data, explain briefly the approach taken. |
| --- | --- |

—

Where sampling or estimations have been used to compile the data, explain briefly the approach taken.

| — | Give details of training programmes or activities targeted at rail employees. |
| --- | --- |

—

Give details of training programmes or activities targeted at rail employees.

| — | Specify whether the competent authority has made use of the right given to it in Article 4(5) of Regulation (EC) No 1370/2007 of the European Parliament and of the Council (21) as regards the rights of staff and social standards applicable to public service operators. |
| --- | --- |

—

Specify whether the competent authority has made use of the right given to it in Article 4(5) of Regulation (EC) No 1370/2007 of the European Parliament and of the Council (21) as regards the rights of staff and social standards applicable to public service operators.

| — | If in Table 10.1 the data on the ‘staff of other companies providing services related to rail transport’ have been reported, explain briefly which companies were included. |
| --- | --- |

—

If in Table 10.1 the data on the ‘staff of other companies providing services related to rail transport’ have been reported, explain briefly which companies were included.

| |
| --- |

11.   Service facilities

11.1.   Ownership and management of main service facilities

For the purpose of this questionnaire, service facilities are as defined in Annex II to Directive 2012/34/EU. Please indicate the number of facilities operated under each type of ownership or operator.

| Infrastructure facility | Ownership | Operator |
| --- | --- | --- |
| Incumbent railway undertaking and companies related to it (22) | Other companies | Incumbent railway undertaking and companies related to it | Other companies |
| Infrastructure managers | Railway undertakings | Integrated companies (23) | Government (24) | Other | Infrastructure managers | Railway undertakings | Integrated companies | Government | Other |
| Total stations | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Stations serving over 25 000 travellers per day | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Stations serving 10 000-25 000 travellers per day | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Stations serving 1 000-10 000 travellers per day | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Stations serving less than 1 000 travellers per day | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| |
| Freight terminals | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Marshalling yards | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Maintenance facilities | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Maritime and inland port facilities connected to rail services | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |
| Refuelling facilities | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ | ☐☐☐ |

Infrastructure facility

Ownership

Operator

Incumbent railway undertaking and companies related to it (22)

Other companies

Incumbent railway undertaking and companies related to it

Other companies

Infrastructure managers

Railway undertakings

Integrated companies (23)

Government (24)

Other

Infrastructure managers

Railway undertakings

Integrated companies

Government

Other

Total stations

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Stations serving over 25 000 travellers per day

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Stations serving 10 000-25 000 travellers per day

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Stations serving 1 000-10 000 travellers per day

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Stations serving less than 1 000 travellers per day

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Freight terminals

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Marshalling yards

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Maintenance facilities

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Maritime and inland port facilities connected to rail services

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

Refuelling facilities

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

☐☐☐

11.2.   Number of complaints relating to service facilities

Please state the number of complaints made about the access to facilities, the level of charges or the quality of the services provided.

| Complaints currently being processed by the regulatory body | ☐☐☐ |
| --- | --- |
| Decisions taken on complaints during the reporting period | ☐☐☐ |

Complaints currently being processed by the regulatory body

☐☐☐

Decisions taken on complaints during the reporting period

☐☐☐

11.3.   Description of complaints:

Please provide a short and general description of the main cases (up to ten) on which a decision has been taken during the reporting period. State whether any of the complaints raised questions as to the interpretation of the European railway acquis and outline the actions proposed to remedy the situation.

| 1. | |
| --- | --- |

1.

| 2. | |
| --- | --- |

2.

| 3. | |
| --- | --- |

3.

| 4. | |
| --- | --- |

4.

| 5. | |
| --- | --- |

5.

| 6. | |
| --- | --- |

6.

| 7. | |
| --- | --- |

7.

| 8. | |
| --- | --- |

8.

| 9. | |
| --- | --- |

9.

| 10. | |
| --- | --- |

10.

11.4.   Additional comments (*):

Please add any further comments, including the following points:

| — | During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested. |
| --- | --- |

—

During the transitional period referred to in Article 4 of the Regulation, provide information in case the data reported does not fully comply with the content and/or format requested.

| — | Specify whether the regulatory bodies of other Member States gave been consulted on any occasion. |
| --- | --- |

—

Specify whether the regulatory bodies of other Member States gave been consulted on any occasion.

| |
| --- |

---

(1)  Given the variety of possible approaches which could be taken when calculating the TACs, the data provided in this table by different Member States will not necessarily be comparable and will mainly be useful for monitoring trends within each Member State.

(2)  As specified in point 3 of Annex V to Directive 2012/34/EU.

(3)  European Rail Traffic Management System.

(4)  For the purpose of this questionnaire, stations serving over 10 000 passengers per weekday are considered to be ‘major stations’, and freight terminals with a capacity of over 100 000 containers per year or over 1 million tonnes per year are considered to be ‘major freight terminals’.

(5)  The total of the expenditure reported in Tables 3.1 and 3.2 should generally be approximately equal.

(6)  The figure reported here should be the same as that reported in Table 6.1. Concession payments from an operator to a public authority should be treated as ‘negative’ PSO compensations.

(7)  The figure reported here should be the same as that reported in Table 6.1

(8)  For timetabled services only.

(9)  Regulation (EU) No 913/2010 of the European Parliament and of the Council of 22 September 2010 concerning a European rail network for competitive freight (OJ L 276, 20.10.2010, p. 22).

(10)  Concession payments from an operator to public authority should be treated as ‘negative’ PSO compensation.

(11)  Agreed arrangement for rolling stock provision for each contract, e.g. owned, subsidised or guaranteed by the contracting authority; provided by the railway undertaking or leased.

(12)  On the basis of passenger-km provided on the national territory during the reporting period. The total of the column should be 100 %.

(13)  On the basis of passenger-km provided on the national territory during the reporting period. The total of the column should be 100 %.

(14)  On the basis of tonne-km provided on the national territory during the reporting period. The total of the column should be 100 %.

(15)  Member States will no longer be obliged to fill out this section once information on railway undertakings' licences is available for all Member States in the European Railway Agency Database of Interoperability and Safety (Eradis).

(16)  Excluding licences reactivated during the reporting period.

(17)  The scope of the reporting should cover at least 50 % of the market (based on passenger-km and tonne-km).

(18)  Where they are not included in the railway undertaking's or infrastructure manager's staff given above.

(19)  A + B = 100 %.

(20)  The scope of the reporting should cover at least 50 % of the market (based on passenger-km and tonne-km).

(21)  Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70 (OJ L 315, 3.12.2007, p. 1).

(22)  Including integrated infrastructure managers and holding companies.

(23)  Including non-incumbent railway undertakings and infrastructure managers, which are part of an integrated company.

(24)  National, regional or local government.

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/27 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/27

---

COMMISSION REGULATION (EU) 2015/1101

of 8 July 2015

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 difenoconazole, fluopicolide, fluopyram, isopyrazam and pendimethalin 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) thereof,

Whereas:

| (1) | For pendimethalin maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For difenoconazole, fluopicolide, fluopyram and isopyrazam MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005. |
| --- | --- |

(1)

For pendimethalin maximum residue levels (MRLs) were set in Annex II to Regulation (EC) No 396/2005. For difenoconazole, fluopicolide, fluopyram and isopyrazam MRLs were set in Part A of Annex III to Regulation (EC) No 396/2005.

| (2) | In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance difenoconazole on lettuces, lamb's lettuce, scarole, rocket and basil, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs. |
| --- | --- |

(2)

In the context of a procedure for the authorisation of the use of a plant protection product containing the active substance difenoconazole on lettuces, lamb's lettuce, scarole, rocket and basil, an application was submitted in accordance with Article 6(1) of Regulation (EC) No 396/2005 for modification of the existing MRLs.

| (3) | As regards fluopicolide, such an application was submitted for garlic and shallots. As regards fluopyram, such an application was submitted for apricots, peaches, plums, cane fruit, other small fruits and berries of code number 0154000, other root and tuber vegetables of code number 0213000, aubergines, scarole, spinaches, witloof, beans (without pods), peas (with pods), linseed, poppy seed, mustard seed, gold of pleasure, herbal infusions (dried roots), hops, spices (roots or rhizome), chicory roots. As regards isopyrazam, such an application was submitted for tomatoes, aubergines and cucurbits. As regards pendimethalin, such an application was submitted for carrots, celeriac, horseradish, parsnips, parsley root, salsify, swedes, turnips, root and rhizome spices, chicory roots. |
| --- | --- |

(3)

As regards fluopicolide, such an application was submitted for garlic and shallots. As regards fluopyram, such an application was submitted for apricots, peaches, plums, cane fruit, other small fruits and berries of code number 0154000, other root and tuber vegetables of code number 0213000, aubergines, scarole, spinaches, witloof, beans (without pods), peas (with pods), linseed, poppy seed, mustard seed, gold of pleasure, herbal infusions (dried roots), hops, spices (roots or rhizome), chicory roots. As regards isopyrazam, such an application was submitted for tomatoes, aubergines and cucurbits. As regards pendimethalin, such an application was submitted for carrots, celeriac, horseradish, parsnips, parsley root, salsify, swedes, turnips, root and rhizome spices, chicory roots.

| (4) | In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission. |
| --- | --- |

(4)

In accordance with Article 8 of Regulation (EC) No 396/2005 these applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission.

| (5) | The European Food Safety Authority, hereinafter ‘the Authority’, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public. |
| --- | --- |

(5)

The European Food Safety Authority, hereinafter ‘the Authority’, assessed the applications and the evaluation reports, examining in particular the risks to the consumer and, where relevant, to animals and gave reasoned opinions on the proposed MRLs (2). It forwarded these opinions to the Commission and the Member States and made them available to the public.

| (6) | The Authority concluded in its reasoned opinions that, as regards the use of fluopyram on apricots and chicory roots, the submitted data were not sufficient to set new MRLs. Based on the relevant reasoned opinion, the use of difenoconazole on lettuce and rocket does not require a modification of the existing MRLs. As regards the use of pendimethalin on root and rhizome spices, the evaluating Member State confirmed that there are no authorised uses on those crops. The existing MRLs should therefore remain unchanged. |
| --- | --- |

(6)

The Authority concluded in its reasoned opinions that, as regards the use of fluopyram on apricots and chicory roots, the submitted data were not sufficient to set new MRLs. Based on the relevant reasoned opinion, the use of difenoconazole on lettuce and rocket does not require a modification of the existing MRLs. As regards the use of pendimethalin on root and rhizome spices, the evaluating Member State confirmed that there are no authorised uses on those crops. The existing MRLs should therefore remain unchanged.

| (7) | As regards fluopicolide, the Authority assessed an application with a view of setting an MRL for onions resulting from EU uses and gave a reasoned opinion on the proposed MRL (3). Although it recommended to keep the Codex maximum residue limit (CXL) that had been set for that crop at the level of 1 mg/kg by Commission Regulation (EU) No 520/2011 (4), it confirmed that for onions, an MRL at a level of 0,3 mg/kg would have been appropriate if based solely on the Good Agricultural Practices (GAPs) in the Union. In accordance with the existing EU guidelines on extrapolation of MRLs, it is appropriate to set that MRL value of 0,3 mg/kg for garlic and shallots. |
| --- | --- |

(7)

As regards fluopicolide, the Authority assessed an application with a view of setting an MRL for onions resulting from EU uses and gave a reasoned opinion on the proposed MRL (3). Although it recommended to keep the Codex maximum residue limit (CXL) that had been set for that crop at the level of 1 mg/kg by Commission Regulation (EU) No 520/2011 (4), it confirmed that for onions, an MRL at a level of 0,3 mg/kg would have been appropriate if based solely on the Good Agricultural Practices (GAPs) in the Union. In accordance with the existing EU guidelines on extrapolation of MRLs, it is appropriate to set that MRL value of 0,3 mg/kg for garlic and shallots.

| (8) | As regards fluopyram, the applicant clarified that the GAP on peaches refers to both Northern and Southern EU. Moreover, it provided further information outlining the experimental designs and the GAP on cane fruit. In view of such, it is appropriate to set MRLs at the level of 1,5 mg/kg for peaches and 3 mg/kg for cane fruit. |
| --- | --- |

(8)

As regards fluopyram, the applicant clarified that the GAP on peaches refers to both Northern and Southern EU. Moreover, it provided further information outlining the experimental designs and the GAP on cane fruit. In view of such, it is appropriate to set MRLs at the level of 1,5 mg/kg for peaches and 3 mg/kg for cane fruit.

| (9) | As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded. |
| --- | --- |

(9)

As regards all other applications, the Authority concluded that all requirements with respect to data were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. It took into account the most recent information on the toxicological properties of the substances. Neither the lifetime exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant crops and products showed that there is a risk that the acceptable daily intake (ADI) or the acute reference dose (ARfD) is exceeded.

| (10) | Based on the reasoned opinions 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)

Based on the reasoned opinions 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.

| (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, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  EFSA scientific reports available online: http://www.efsa.europa.eu

2

| | Reasoned opinion on the modification of the existing MRLs for difenoconazole in lettuce and other salad plants including Brassicaceae and in basil (mint). EFSA Journal 2014;12(10):3882 [26 pp.]. |
| --- | --- |

Reasoned opinion on the modification of the existing MRLs for difenoconazole in lettuce and other salad plants including Brassicaceae and in basil (mint). EFSA Journal 2014;12(10):3882 [26 pp.].

EFSA Journal

| | Reasoned opinion on the modification of the existing MRLs for fluopyram in various crops. EFSA Journal 2014;12(12):3947 [33 pp.]. |
| --- | --- |

Reasoned opinion on the modification of the existing MRLs for fluopyram in various crops. EFSA Journal 2014;12(12):3947 [33 pp.].

EFSA Journal

| | Reasoned opinion on the modification of the existing MRLs for isopyrazam in various crops. EFSA Journal 2015;13(1):3994 [25 pp.]. |
| --- | --- |

Reasoned opinion on the modification of the existing MRLs for isopyrazam in various crops. EFSA Journal 2015;13(1):3994 [25 pp.].

EFSA Journal

| | Reasoned opinion on the modification of the existing MRLs for pendimethalin in various crops. EFSA Journal 2014;12(4):3620 [32 pp.]. |
| --- | --- |

Reasoned opinion on the modification of the existing MRLs for pendimethalin in various crops. EFSA Journal 2014;12(4):3620 [32 pp.].

EFSA Journal

(3)  Reasoned opinion on the modification of the existing MRLs for fluopicolide in radishes, onions, kale and potatoes. EFSA Journal 2012;10(2):2581 [39 pp.].

3

EFSA Journal

(4)  Commission Regulation (EU) No 520/2011 of 25 May 2011 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 benalaxyl, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, indoxacarb, metaflumizone, methoxyfenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and zoxamide in or on certain products (OJ L 140, 27.5.2011, p. 2).

4

---

ANNEX

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

| (1) | In Annex II, the column for pendimethalin is replaced by the following:

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








  Code number | Groups and examples of individual products to which the MRLs apply (2) | Pendimethalin (F) |
| --- | --- | --- | --- |
| (1) | (2) | (3) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | 0,05 (1) |
| 0110000 | Citrus fruits | |
| 0110010 | Grapefruits | |
| 0110020 | Oranges | |
| 0110030 | Lemons | |
| 0110040 | Limes | |
| 0110050 | Mandarins | |
| 0110990 | Others | |
| 0120000 | Tree nuts | |
| 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 | |
| 0130010 | Apples | |
| 0130020 | Pears | |
| 0130030 | Quinces | |
| 0130040 | Medlars | |
| 0130050 | Loquats/Japanese medlars | |
| 0130990 | Others | |
| 0140000 | Stone fruits | |
| 0140010 | Apricots | |
| 0140020 | Cherries (sweet) | |
| 0140030 | Peaches | |
| 0140040 | Plums | |
| 0140990 | Others | |
| 0150000 | Berries and small fruits | |
| 0151000 | (a) | grapes |

(1)

In Annex II, the column for pendimethalin is replaced by the following:

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

Code number

Groups and examples of individual products to which the MRLs apply (2)

Pendimethalin (F)

(1)

(2)

(3)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,05 (1)

0110000

Citrus fruits

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

0120000

Tree nuts

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

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others

0140000

Stone fruits

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0150000

Berries and small fruits

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

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

0211000

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

(a)

0,05 (1)

0212000

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

(b)

0,05 (1)

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

0,05 (1)

0213020

Carrots

0,7

0213030

Celeriacs/turnip rooted celeries

0,2

0213040

Horseradishes

0,7

0213050

Jerusalem artichokes

0,05 (1)

0213060

Parsnips

0,7

0213070

Parsley roots/Hamburg roots parsley

0,7

0213080

Radishes

0,05 (1)

0213090

Salsifies

0,7

0213100

Swedes/rutabagas

0,4

0213110

Turnips

0,4

0213990

Others

0,05 (1)

0220000

Bulb vegetables

0,05 (1)

0220010

Garlic

(+)

0220020

Onions

(+)

0220030

Shallots

(+)

0220040

Spring onions/green onions and Welsh onions

0220990

Others

0230000

Fruiting vegetables

0,05 (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)

0241000

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

(a)

0,05 (1)

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0242000

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

(b)

0,05 (1)

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others

0243000

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

(c)

0,5

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others

0244000

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

(d)

0,3

0250000

Leaf vegetables, herbs and edible flowers

0251000

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

(a)

0251010

Lamb's lettuces/corn salads

0,6

0251020

Lettuces

0,05 (1)

0251030

Escaroles/broad-leaved endives

0,05 (1)

0251040

Cresses and other sprouts and shoots

0,6

0251050

Land cresses

0,05 (1)

0251060

Roman rocket/rucola

0,6

0251070

Red mustards

0,05 (1)

0251080

Baby leaf crops (including brassica species)

0,6

0251990

Others

0,05 (1)

0252000

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

(b)

0,05 (1)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0253000

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

(c)

0,05 (1)

0254000

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

(d)

0,05 (1)

0255000

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

(e)

0,05 (1)

0256000

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

(f)

0256010

Chervil

0,6

0256020

Chives

0,6

0256030

Celery leaves

0,6

0256040

Parsley

2

0256050

Sage

2

0256060

Rosemary

0,6

0256070

Thyme

0,6

0256080

Basil and edible flowers

0,6

0256090

Laurel/bay leave

0,6

0256100

Tarragon

0,6

0256990

Others

0,6

0260000

Legume vegetables

0,05 (1)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others

0270000

Stem vegetables

0270010

Asparagus

0,05 (1)

0270020

Cardoons

0,05 (1)

0270030

Celeries

0,1

0270040

Florence fennels

0,1

0270050

Globe artichokes

0,05 (1) (+)

0270060

Leeks

0,05 (1) (+)

0270070

Rhubarbs

0,05 (1)

0270080

Bamboo shoots

0,05 (1)

0270090

Palm hearts

0,05 (1)

0270990

Others

0,05 (1)

0280000

Fungi, mosses and lichens

0,05 (1)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,05 (1)

0300000

PULSES

0,15

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others

0400000

OILSEEDS AND OIL FRUITS

0,05 (1)

0401000

Oilseeds

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

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others

0500000

CEREALS

0,05 (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

0,05 (1)

0620000

Coffee beans

0,05 (1)

0630000

Herbal infusions from

0631000

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

(a)

0,05 (1)

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

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

(b)

0,05 (1)

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

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

(c)

0,5

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

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

(d)

0,05 (1)

0640000

Cocoa beans

0,05 (1)

0650000

Carobs/Saint John's breads

0,05 (1)

0700000

HOPS

0,05 (1)

0800000

SPICES

0810000

Seed spices

0,05 (1)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

Fruit spices

0,05 (1)

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

0,05 (1)

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,05 (1)

0840020

Ginger

0,05 (1)

0840030

Turmeric/curcuma

0,05 (1)

0840040

Horseradish

(+)

0840990

Others

0,05 (1)

0850000

Bud spices

0,05 (1)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,05 (1)

0860010

Saffron

0860990

Others

0870000

Aril spices

0,05 (1)

0870010

Mace

0870990

Others

0900000

SUGAR PLANTS

0900010

Sugar beet roots

0,05 (1)

0900020

Sugar canes

0,05 (1)

0900030

Chicory roots

0,2

0900990

Others

0,05 (1)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

0,01 (1)

1011000

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

(a)

1011010

Muscle

1011020

Fat tissue

1011030

Liver

(+)

1011040

Kidney

(+)

1011050

Edible offals (other than liver and kidney)

1011990

Others

1012000

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

(b)

1012010

Muscle

1012020

Fat tissue

1012030

Liver

(+)

1012040

Kidney

(+)

1012050

Edible offals (other than liver and kidney)

1012990

Others

1013000

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

(c)

1013010

Muscle

1013020

Fat tissue

1013030

Liver

(+)

1013040

Kidney

(+)

1013050

Edible offals (other than liver and kidney)

1013990

Others

1014000

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

d)

1014010

Muscle

1014020

Fat tissue

1014030

Liver

(+)

1014040

Kidney

(+)

1014050

Edible offals (other than liver and kidney)

1014990

Others

1015000

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

(e)

1015010

Muscle

1015020

Fat tissue

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others

1016000

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

(f)

1016010

Muscle

1016020

Fat tissue

1016030

Liver

(+)

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others

1017000

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

(g)

1017010

Muscle

1017020

Fat tissue

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others

1020000

Milk

0,01 (1)

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

0,05 (1)

1050000

Amphibians and Reptiles

0,01 (1)

1060000

Terrestrial invertebrate animals

0,01 (1)

1070000

Wild terrestrial vertebrate animals

0,01 (1)

| (2) | In Part A of Annex III, the columns for difenoconazole, fluopicolide, fluopyram and isopyrazam are replaced by the following:

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











  Code number | Groups and examples of individual products to which the MRLs apply (4) | Difenoconazole | Fluopicolide | Fluopyram (R) | Isopyrazam |
| --- | --- | --- | --- | --- | --- | --- |
| (1) | (2) | (3) | (4) | (5) | (6) |
| 0100000 | FRUITS, FRESH or FROZEN; TREE NUTS | | | | |
| 0110000 | Citrus fruits | 0,6 | 0,01 (3) | 0,01 (3) | 0,01 (3) |
| 0110010 | Grapefruits | | | | |
| 0110020 | Oranges | | | | |
| 0110030 | Lemons | | | | |
| 0110040 | Limes | | | | |
| 0110050 | Mandarins | | | | |
| 0110990 | Others | | | | |
| 0120000 | Tree nuts | 0,05 (3) | 0,01 (3) | | 0,01 (3) |
| 0120010 | Almonds | | | 0,05 | |
| 0120020 | Brazil nuts | | | 0,05 | |
| 0120030 | Cashew nuts | | | 0,05 | |
| 0120040 | Chestnuts | | | 0,05 | |
| 0120050 | Coconuts | | | 0,04 | |
| 0120060 | Hazelnuts/cobnuts | | | 0,05 | |
| 0120070 | Macadamias | | | 0,05 | |
| 0120080 | Pecans | | | 0,05 | |
| 0120090 | Pine nut kernels | | | 0,05 | |
| 0120100 | Pistachios | | | 0,05 | |
| 0120110 | Walnuts | | | 0,05 | |
| 0120990 | Others | | | 0,05 | |
| 0130000 | Pome fruits | 0,8 | 0,01 (3) | | 0,7 |
| 0130010 | Apples | | | 0,6 | |
| 0130020 | Pears | | | 0,5 | |
| 0130030 | Quinces | | | 0,5 | |
| 0130040 | Medlars | | | 0,5 | |
| 0130050 | Loquats/Japanese medlars | | | 0,5 | |
| 0130990 | Others | | | 0,5 | |
| 0140000 | Stone fruits | | 0,01 (3) | | |
| 0140010 | Apricots | 0,5 | | 0,7 | 0,01 (3) |
| 0140020 | Cherries (sweet) | 0,3 | | 1,5 | 0,01 (3) |
| 0140030 | Peaches | 0,5 | | 1,5 | 1,5 |
| 0140040 | Plums | 0,5 | | 0,5 | 0,01 (3) |
| 0140990 | Others | 0,1 | | 0,01 (3) | 0,01 (3) |
| 0150000 | Berries and small fruits | | | | 0,01 (3) |
| 0151000 | (a) | grapes |

(2)

In Part A of Annex III, the columns for difenoconazole, fluopicolide, fluopyram and isopyrazam are replaced by the following:

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

Code number

Groups and examples of individual products to which the MRLs apply (4)

Difenoconazole

Fluopicolide

Fluopyram (R)

Isopyrazam

(1)

(2)

(3)

(4)

(5)

(6)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0110000

Citrus fruits

0,6

0,01 (3)

0,01 (3)

0,01 (3)

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

0120000

Tree nuts

0,05 (3)

0,01 (3)

0,01 (3)

0120010

Almonds

0,05

0120020

Brazil nuts

0,05

0120030

Cashew nuts

0,05

0120040

Chestnuts

0,05

0120050

Coconuts

0,04

0120060

Hazelnuts/cobnuts

0,05

0120070

Macadamias

0,05

0120080

Pecans

0,05

0120090

Pine nut kernels

0,05

0120100

Pistachios

0,05

0120110

Walnuts

0,05

0120990

Others

0,05

0130000

Pome fruits

0,8

0,01 (3)

0,7

0130010

Apples

0,6

0130020

Pears

0,5

0130030

Quinces

0,5

0130040

Medlars

0,5

0130050

Loquats/Japanese medlars

0,5

0130990

Others

0,5

0140000

Stone fruits

0,01 (3)

0140010

Apricots

0,5

0,7

0,01 (3)

0140020

Cherries (sweet)

0,3

1,5

0,01 (3)

0140030

Peaches

0,5

1,5

1,5

0140040

Plums

0,5

0,5

0,01 (3)

0140990

Others

0,1

0,01 (3)

0,01 (3)

0150000

Berries and small fruits

0,01 (3)

0151000

(a)

3

2

1,5

0151010

Table grapes

0151020

Wine grapes

0152000

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

(b)

0,4

0,01 (3)

2

0153000

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

(c)

0,01 (3)

3

0153010

Blackberries

1,5

0153020

Dewberries

0,1

0153030

Raspberries (red and yellow)

1,5

0153990

Others

0,1

0154000

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

(d)

0,01 (3)

3

0154010

Blueberries

0,1

0154020

Cranberries

0,1

0154030

Currants (black, red and white)

0,2

0154040

Gooseberries (green, red and yellow)

0,1

0154050

Rose hips

0,1

0154060

Mulberries (black and white)

0,1

0154070

Azaroles/Mediterranean medlars

0,8

0154080

Elderberries

0,1

0154990

Others

0,1

0160000

Miscellaneous fruits with

0,01 (3)

0161000

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

(a)

0,01 (3)

0,01 (3)

0161010

Dates

0,1

0161020

Figs

0,1

0161030

Table olives

2

0161040

Kumquats

0,6

0161050

Carambolas

0,1

0161060

Kaki/Japanese persimmons

0,8

0161070

Jambuls/jambolans

0,1

0161990

Others

0,1

0162000

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

(b)

0,1

0,01 (3)

0,01 (3)

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

0,1

0,01 (3)

0,01 (3)

0163020

Bananas

0,1

0,8

0,05

0163030

Mangoes

0,1

0,01 (3)

0,01 (3)

0163040

Papayas

0,2

0,01 (3)

0,01 (3)

0163050

Granate apples/pomegranates

0,1

0,01 (3)

0,01 (3)

0163060

Cherimoyas

0,1

0,01 (3)

0,01 (3)

0163070

Guavas

0,1

0,01 (3)

0,01 (3)

0163080

Pineapples

0,1

0,01 (3)

0,01 (3)

0163090

Breadfruits

0,1

0,01 (3)

0,01 (3)

0163100

Durians

0,1

0,01 (3)

0,01 (3)

0163110

Soursops/guanabanas

0,1

0,01 (3)

0,01 (3)

0163990

Others

0,1

0,01 (3)

0,01 (3)

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0211000

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

(a)

0,1

0,03

0,1

0,01 (3)

0212000

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

(b)

0,1

0,01

0,1

0,01 (3)

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others

0213000

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

(c)

0,15

0,2

0213010

Beetroots

0,4

0,3

0213020

Carrots

0,4

0,4

0213030

Celeriacs/turnip rooted celeries

2

0,3

0213040

Horseradishes

0,4

0,3

0213050

Jerusalem artichokes

0,4

0,3

0213060

Parsnips

0,4

0,3

0213070

Parsley roots/Hamburg roots parsley

0,4

0,3

0213080

Radishes

0,4

0,3

0213090

Salsifies

0,4

0,3

0213100

Swedes/rutabagas

0,4

0,3

0213110

Turnips

0,4

0,3

0213990

Others

0,4

0,3

0220000

Bulb vegetables

0,01 (3)

0220010

Garlic

0,5

0,3

0,1

0220020

Onions

0,5

1

0,1

0220030

Shallots

0,5

0,3

0,1

0220040

Spring onions/green onions and Welsh onions

9

10

2

0220990

Others

0,5

0,01 (3)

0,1

0230000

Fruiting vegetables

0231000

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

(a)

1

0231010

Tomatoes

2

0,9

0,5

0231020

Sweet peppers/bell peppers

0,8

0,8

0,09

0231030

Aubergines/eggplants

0,6

0,9

0,5

0231040

Okra/lady's fingers

0,05 (3)

0,01 (3)

0,01 (3)

0231990

Others

0,05 (3)

0,1 (+)

0,01 (3)

0232000

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

(b)

0,3

0,5

0,5

0,4

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others

0233000

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

(c)

0,2

0,5

0,4

0,3

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others

0234000

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

(d)

0,05 (3)

0,01 (3)

0,1 (+)

0,01 (3)

0239000

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

(e)

0,05 (3)

0,01 (3)

0,1 (+)

0,01 (3)

0240000

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

0,01 (3)

0241000

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

(a)

2

0,2

0241010

Broccoli

1

0241020

Cauliflowers

0,2

0241990

Others

0,05 (3)

0242000

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

(b)

0,2

0242010

Brussels sprouts

0,2

0,2

0242020

Head cabbages

0,2

0,3

0242990

Others

0,01 (3)

0,1 (+)

0243000

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

(c)

2

0243010

Chinese cabbages/pe-tsai

2

0,7

0243020

Kales

2

0,1 (+)

0243990

Others

0,1

0,1 (+)

0244000

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

(d)

0,05 (3)

0,03

0,1 (+)

0250000

Leaf vegetables, herbs and edible flowers

0,01 (3)

0251000

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

(a)

0251010

Lamb's lettuces/corn salads

7

9

15

0251020

Lettuces

3

9

15

0251030

Escaroles/broad-leaved endives

0,7

1,5

1,5

0251040

Cresses and other sprouts and shoots

0,05 (3)

9

15

0251050

Land cresses

0,05 (3)

9

15

0251060

Roman rocket/rucola

2

9

15

0251070

Red mustards

0,05 (3)

9

15

0251080

Baby leaf crops (including brassica species)

0,05 (3)

9

15

0251990

Others

0,05 (3)

9

15

0252000

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

(b)

4

0252010

Spinaches

2

0,2

0252020

Purslanes

2

0,1 (+)

0252030

Chards/beet leaves

0,2

0,1 (+)

0252990

Others

0,05 (3)

0,1 (+)

0253000

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

(c)

0,05 (3)

0,01 (3)

0,01 (3)

0254000

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

(d)

0,5

0,01 (3)

0,1 (+)

0255000

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

(e)

0,08

0,01 (3)

0,15

0256000

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

(f)

9

0,1 (+)

0256010

Chervil

10

0256020

Chives

2

0256030

Celery leaves

10

0256040

Parsley

10

0256050

Sage

2

0256060

Rosemary

2

0256070

Thyme

2

0256080

Basil and edible flowers

10

0256090

Laurel/bay leave

2

0256100

Tarragon

2

0256990

Others

2

0260000

Legume vegetables

0,01 (3)

0,01 (3)

0260010

Beans (with pods)

1

0,9

0260020

Beans (without pods)

1

0,15

0260030

Peas (with pods)

1

0,4

0260040

Peas (without pods)

1

0,15

0260050

Lentils

0,05 (3)

0,1 (+)

0260990

Others

0,05 (3)

0,1 (+)

0270000

Stem vegetables

0,01 (3)

0270010

Asparagus

0,05 (3)

0,01 (3)

0,01 (3)

0270020

Cardoons

4

0,01 (3)

0,1 (+)

0270030

Celeries

5

0,01 (3)

0,1 (+)

0270040

Florence fennels

5

0,01 (3)

0,1 (+)

0270050

Globe artichokes

1

0,01 (3)

0,5

0270060

Leeks

0,5

1,5

0,7

0270070

Rhubarbs

0,3

0,01 (3)

0,01 (3)

0270080

Bamboo shoots

0,05 (3)

0,01 (3)

0,01 (3)

0270090

Palm hearts

0,05 (3)

0,01 (3)

0,01 (3)

0270990

Others

0,05 (3)

0,01 (3)

0,1 (+)

0280000

Fungi, mosses and lichens

0,05 (3)

0,01 (3)

0,01 (3)

0,01 (3)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,05 (3)

0,01 (3)

0,01 (3)

0,01 (3)

0300000

PULSES

0,01 (3)

0,4

0,01 (3)

0300010

Beans

0,05 (3)

0300020

Lentils

0,05 (3)

0300030

Peas

0,1

0300040

Lupins/lupini beans

0,05 (3)

0300990

Others

0,05 (3)

0400000

OILSEEDS AND OIL FRUITS

0,01 (3)

0401000

Oilseeds

0401010

Linseeds

0,2

0,3

0,4

0401020

Peanuts/groundnuts

0,05 (3)

0,03

0,01 (3)

0401030

Poppy seeds

0,05 (3)

0,3

0,4

0401040

Sesame seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401050

Sunflower seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401060

Rapeseeds/canola seeds

0,5

0,6

0,4

0401070

Soyabeans

0,05 (3)

0,2

0,01 (3)

0401080

Mustard seeds

0,2

0,3

0,4

0401090

Cotton seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401100

Pumpkin seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401110

Safflower seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401120

Borage seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401130

Gold of pleasure seeds

0,05 (3)

0,3

0,01 (3)

0401140

Hemp seeds

0,05 (3)

0,1 (+)

0,01 (3)

0401150

Castor beans

0,05 (3)

0,1 (+)

0,01 (3)

0401990

Others

0,05 (3)

0,1 (+)

0,01 (3)

0402000

Oil fruits

0,01 (3)

0,01 (3)

0402010

Olives for oil production

2

0402020

Oil palms kernels

0,05 (3)

0402030

Oil palms fruits

0,05 (3)

0402040

Kapok

0,05 (3)

0402990

Others

0,05 (3)

0500000

CEREALS

0,01 (3)

0500010

Barley

0,05 (3)

0,1 (+)

0,6

0500020

Buckwheat and other pseudo-cereals

0,05 (3)

0,1 (+)

0,01 (3)

0500030

Maize/corn

0,05 (3)

0,02

0,01 (3)

0500040

Common millet/proso millet

0,05 (3)

0,1 (+)

0,01 (3)

0500050

Oat

0,05 (3)

0,1 (+)

0,6

0500060

Rice

3

0,01 (3)

0,01 (3)

0500070

Rye

0,1

0,8

0,2

0500080

Sorghum

0,05 (3)

1,5

0,01 (3)

0500090

Wheat

0,1

0,8

0,2

0500990

Others

0,05 (3)

0,1 (+)

0,01 (3)

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,02 (3)

0,01 (3)

0610000

Teas

0,05 (3)

0,01 (3)

0620000

Coffee beans

0,05 (3)

0,01 (3)

0630000

Herbal infusions from

20

0631000

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

(a)

0,1 (+)

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

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

(b)

0,1 (+)

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

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

(c)

2,5

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

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

(d)

0,1 (+)

0640000

Cocoa beans

0,05 (3)

0,01 (3)

0650000

Carobs/Saint John's breads

0,05 (3)

0,01 (3)

0700000

HOPS

0,05 (3)

0,7

3

0,01 (3)

0800000

SPICES

0810000

Seed spices

0,3

0,02 (3)

0,1 (+)

0,01 (3)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

Fruit spices

0,3

0,02 (3)

0,01 (3)

0820010

Allspice/pimento

0,01 (3)

0820020

Sichuan pepper

0,01 (3)

0820030

Caraway

0,1 (+)

0820040

Cardamom

0,01 (3)

0820050

Juniper berry

0,01 (3)

0820060

Peppercorn (black, green and white)

0,01 (3)

0820070

Vanilla

0,01 (3)

0820080

Tamarind

0,01 (3)

0820990

Others

0,01 (3)

0830000

Bark spices

0,3

0,02 (3)

0,01 (3)

0,01 (3)

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,3

0,02 (3)

0,3

0,01 (3)

0840020

Ginger

0,3

0,02 (3)

0,3

0,01 (3)

0840030

Turmeric/curcuma

0,3

0,02 (3)

0,3

0,01 (3)

0840040

Horseradish

(+)

(+)

(+)

(+)

0840990

Others

0,3

0,02 (3)

0,3

0,01 (3)

0850000

Bud spices

0,3

0,02 (3)

0,01 (3)

0,01 (3)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,3

0,02 (3)

0,01 (3)

0,01 (3)

0860010

Saffron

0860990

Others

0870000

Aril spices

0,3

0,02 (3)

0,01 (3)

0,01 (3)

0870010

Mace

0870990

Others

0900000

SUGAR PLANTS

0,01 (3)

0900010

Sugar beet roots

0,2

0,15

0,1 (+)

0900020

Sugar canes

0,05 (3)

0,01 (3)

0,01 (3)

0900030

Chicory roots

0,6

0,01 (3)

0,1 (+)

0900990

Others

0,05 (3)

0,01 (3)

0,1 (+)

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

0,01 (3)

0,01 (3)

1011000

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

(a)

1011010

Muscle

0,05

0,5

1011020

Fat tissue

0,05

0,5

1011030

Liver

0,2

3

1011040

Kidney

0,2

0,7

1011050

Edible offals (other than liver and kidney)

0,2

0,7

1011990

Others

0,1

0,02 (3)

1012000

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

(b)

1012010

Muscle

0,05

0,5

1012020

Fat tissue

0,05

0,5

1012030

Liver

0,2

3

1012040

Kidney

0,2

0,7

1012050

Edible offals (other than liver and kidney)

0,2

0,7

1012990

Others

0,1

0,02 (3)

1013000

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

(c)

1013010

Muscle

0,05

0,5

1013020

Fat tissue

0,05

0,5

1013030

Liver

0,2

3

1013040

Kidney

0,2

0,7

1013050

Edible offals (other than liver and kidney)

0,2

0,7

1013990

Others

0,1

0,02 (3)

1014000

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

d)

1014010

Muscle

0,05

0,5

1014020

Fat tissue

0,05

0,5

1014030

Liver

0,2

3

1014040

Kidney

0,2

0,7

1014050

Edible offals (other than liver and kidney)

0,2

0,7

1014990

Others

0,1

0,02 (3)

1015000

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

(e)

1015010

Muscle

0,05

0,5

1015020

Fat tissue

0,05

0,5

1015030

Liver

0,2

0,7

1015040

Kidney

0,2

0,7

1015050

Edible offals (other than liver and kidney)

0,2

0,7

1015990

Others

0,1

0,02 (3)

1016000

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

(f)

0,1

1016010

Muscle

0,2

1016020

Fat tissue

0,2

1016030

Liver

0,7

1016040

Kidney

0,7

1016050

Edible offals (other than liver and kidney)

0,7

1016990

Others

0,02 (3)

1017000

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

(g)

1017010

Muscle

0,1

0,5

1017020

Fat tissue

0,1

0,5

1017030

Liver

0,2

0,7

1017040

Kidney

0,2

0,7

1017050

Edible offals (other than liver and kidney)

0,2

0,7

1017990

Others

0,1

0,02 (3)

1020000

Milk

0,005 (3)

0,02

0,3

0,01 (3)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

Birds eggs

0,05 (3)

0,01 (3)

0,3

0,01 (3)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others

1040000

Honey and other apiculture products

0,05 (3)

0,05 (3)

0,05 (3)

0,05 (3)

1050000

Amphibians and Reptiles

0,05 (3)

0,01 (3)

0,02 (3)

0,01 (3)

1060000

Terrestrial invertebrate animals

0,05 (3)

0,01 (3)

0,02 (3)

0,01 (3)

1070000

Wild terrestrial vertebrate animals

0,05 (3)

0,01 (3)

0,02 (3)

0,01 (3)

---

(1)  Indicates lower limit of analytical determination

| (**) | Pesticide-code combination for which the MRL as set in Annex III Part B applies. |
| --- | --- |

(**)

Pesticide-code combination for which the MRL as set in Annex III Part B applies.

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

(F)

=

Fat soluble

Pendimethalin (F)

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.







  0152000 | (b) | strawberries |
| --- | --- | --- | --- |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.

0152000

(b)

0220010

Garlic

0220020

Onions

0220030

Shallots

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

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

0270050

Globe artichokes

0270060

Leeks

| (+) | 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

| (+) | The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.







  1011030 | Liver |
| --- | --- | --- |
| 1011040 | Kidney |
| 1012030 | Liver |
| 1012040 | Kidney |
| 1013030 | Liver |
| 1013040 | Kidney |
| 1014030 | Liver |
| 1014040 | Kidney |
| 1016030 | Liver’ |

(+)

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.

1011030

Liver

1011040

Kidney

1012030

Liver

1012040

Kidney

1013030

Liver

1013040

Kidney

1014030

Liver

1014040

Kidney

1016030

Liver’

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

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

(F)

=

Fat soluble

Pendimethalin (F)

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.







  0152000 | (b) | strawberries |
| --- | --- | --- | --- |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.

0152000

(b)

0220010

Garlic

0220020

Onions

0220030

Shallots

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

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

0270050

Globe artichokes

0270060

Leeks

| (+) | 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

| (+) | The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.







  1011030 | Liver |
| --- | --- | --- |
| 1011040 | Kidney |
| 1012030 | Liver |
| 1012040 | Kidney |
| 1013030 | Liver |
| 1013040 | Kidney |
| 1014030 | Liver |
| 1014040 | Kidney |
| 1016030 | Liver’ |

(+)

The European Food Safety Authority identified some information on analytical methods as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 24.10.2016, or, if that information is not submitted by that date, the lack of it.

1011030

Liver

1011040

Kidney

1012030

Liver

1012040

Kidney

1013030

Liver

1013040

Kidney

1014030

Liver

1014040

Kidney

1016030

Liver’

(3)  Indicates lower limit of analytical determination

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

Difenoconazole

| (+) | 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

Fluopicolide

| (+) | 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

Fluopyram (R)

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Fluopyram — code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram |
| --- | --- | --- |

(R)

=

The residue definition differs for the following combinations pesticide-code number:

Fluopyram — code 1000000: sum fluopyram and fluopyram-benzamide (M25) expressed as fluopyram

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 13 July 2015, or, if that information is not submitted by that date, the lack of it.







  0231990 | Others |
| --- | --- | --- |
| 0234000 | (d) | sweet corn |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 13 July 2015, or, if that information is not submitted by that date, the lack of it.

0231990

Others

0234000

(d)

0239000

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

(e)

0242990

Others

0243020

Kales

0243990

Others

0244000

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

(d)

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0254000

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

(d)

0256000

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

(f)

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

0260050

Lentils

0260990

Others

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270990

Others

0401040

Sesame seeds

0401050

Sunflower seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others

0500010

Barley

0500020

Buckwheat and other pseudo-cereals

0500040

Common millet/proso millet

0500050

Oat

0500990

Others

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

0639000

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

(d)

0810000

Seed spices

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820030

Caraway

| (+) | 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

| (+) | The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 13 July 2015, or, if that information is not submitted by that date, the lack of it.







  0900010 | Sugar beet roots |
| --- | --- | --- |
| 0900030 | Chicory roots |
| 0900990 | Others |

(+)

The European Food Safety Authority identified some information on residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 13 July 2015, or, if that information is not submitted by that date, the lack of it.

0900010

Sugar beet roots

0900030

Chicory roots

0900990

Others

Isopyrazam

| (+) | 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’

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/54 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/54

---

COMMISSION REGULATION (EU) 2015/1102

of 8 July 2015

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of certain flavouring substances

(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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Articles 11(3) and 25(3) 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(4) thereof,

Whereas:

| (1) | Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use. |
| --- | --- |

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

| (2) | Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced it in Annex I Part A to Regulation (EC) No 1334/2008. |
| --- | --- |

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced it in Annex I Part A to Regulation (EC) No 1334/2008.

| (3) | That list 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 submitted by a Member State or by an interested party. |
| --- | --- |

(3)

That list 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 submitted by a Member State or by an interested party.

| (4) | The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority (EFSA) has requested additional scientific data to be provided for completion of the evaluation before specific deadlines established in the Annex I Part A to Regulation (EC) No 1334/2008. |
| --- | --- |

(4)

The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority (EFSA) has requested additional scientific data to be provided for completion of the evaluation before specific deadlines established in the Annex I Part A to Regulation (EC) No 1334/2008.

| (5) | In the case of the five following substances: 1-methylnaphthalene (FL No 01.014), furfuryl methyl ether (FL No 13.052), difurfuryl sulphide (FL No 13.056), difurfuryl ether (FL No 13.061) and ethyl furfuryl ether (FL No 13.123), the deadline of 31 December 2013 was established in the Union list for the submission of requested additional scientific data. |
| --- | --- |

(5)

In the case of the five following substances: 1-methylnaphthalene (FL No 01.014), furfuryl methyl ether (FL No 13.052), difurfuryl sulphide (FL No 13.056), difurfuryl ether (FL No 13.061) and ethyl furfuryl ether (FL No 13.123), the deadline of 31 December 2013 was established in the Union list for the submission of requested additional scientific data.

| (6) | Where the necessary information is not provided by the time requested, the flavouring substance in question will be removed from the Union list. |
| --- | --- |

(6)

Where the necessary information is not provided by the time requested, the flavouring substance in question will be removed from the Union list.

| (7) | Additional scientific data following specific EFSA Opinions (4) relating to these substances have not been submitted by 30 June 2014. Therefore, these flavouring substances should be removed from the Union list. |
| --- | --- |

(7)

Additional scientific data following specific EFSA Opinions (4) relating to these substances have not been submitted by 30 June 2014. Therefore, these flavouring substances should be removed from the Union list.

| (8) | Regulation (EC) No 1334/2008 should therefore be amended accordingly. |
| --- | --- |

(8)

Regulation (EC) No 1334/2008 should therefore be amended accordingly.

| (9) | Article 1 of Commission Regulation (EU) No 873/2012 (5) lays down transitional measures for food containing flavouring substances which are lawfully placed on the market or labelled prior to 22 October 2014. Those transitional measures may not be sufficient for foods containing flavouring substances to be removed from the Union list after 22 October 2014. Therefore, an additional transitional period should be provided for food containing the five flavouring substances in order to enable food business operators to adapt to the requirements laid down in this Regulation. |
| --- | --- |

(9)

Article 1 of Commission Regulation (EU) No 873/2012 (5) lays down transitional measures for food containing flavouring substances which are lawfully placed on the market or labelled prior to 22 October 2014. Those transitional measures may not be sufficient for foods containing flavouring substances to be removed from the Union list after 22 October 2014. Therefore, an additional transitional period should be provided for food containing the five flavouring substances in order to enable food business operators to adapt to the requirements laid down in this Regulation.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(10)

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

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

Foods containing the five flavouring substances mentioned in the Annex to this Regulation which are lawfully placed on the market or labelled prior to 9 months after the entry into force of this Regulation which do not comply with Part A of Annex I to Regulation (EC) No 1334/2008 may be marketed until their date of minimum durability or use by date.

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, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 354, 31.12.2008, p. 34.

1

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

2

(3)  Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

3

(4)  Scientific Opinion on Flavouring Group Evaluation 78 (FGE.78), The EFSA Journal (2009) 931, 1-59; Scientific Opinion on Flavouring Group Evaluation 67, Revision 1 (FGE.67Rev.1), EFSA Journal 2011; 9(10):2315; Scientific Opinion on Flavouring Group Evaluation 65 (FGE.65), EFSA Journal 2010; 8(7):1406.

4

(5)  Commission Regulation (EU) No 873/2012 of 1 October 2012 on transitional measures concerning the Union list of flavourings and source materials set out in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (OJ L 267, 2.10.2012, p. 162).

5

---

ANNEX

In Part A of Annex I to Regulation (EC) No 1334/2008, the following entries are deleted:

| ‘01.014 | 1-Methylnaphthalene | 90-12-0 | 1335 | 11009 | | | 4 | JECFA/EFSA |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 13.052 | Furfuryl methyl ether | 13679-46-4 | 1520 | 10944 | | | 4 | EFSA |
| 13.056 | Difurfuryl sulfide | 13678-67-6 | 1080 | 11438 | | | 4 | EFSA |
| 13.061 | Difurfuryl ether | 4437-22-3 | 1522 | 10930 | | | 4 | EFSA |
| 13.123 | Ethyl furfuryl ether | 6270-56-0 | 1521 | 10940 | | | 4 | EFSA’ |

‘01.014

1-Methylnaphthalene

90-12-0

1335

11009

4

JECFA/EFSA

13.052

Furfuryl methyl ether

13679-46-4

1520

10944

4

EFSA

13.056

Difurfuryl sulfide

13678-67-6

1080

11438

4

EFSA

13.061

Difurfuryl ether

4437-22-3

1522

10930

4

EFSA

13.123

Ethyl furfuryl ether

6270-56-0

1521

10940

4

EFSA’

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/57 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/57

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1103

of 8 July 2015

concerning the authorisation of beta-carotene as a feed additive for all animal species

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | Beta-carotene was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species and was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

Beta-carotene was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on all animal species and was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of beta-carotene and its preparations for all animal species. The applicant requested that additive to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of beta-carotene and its preparations for all animal species. The applicant requested that additive to be classified in the additive category ‘nutritional additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 May 2012 (3) that, under the proposed conditions of use in feed, beta-carotene does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that beta-carotene is used for the synthesis of retinol in almost all species (cats, in particular, were not able to use beta-carotene for the synthesis of retinol) and that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 May 2012 (3) that, under the proposed conditions of use in feed, beta-carotene does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that beta-carotene is used for the synthesis of retinol in almost all species (cats, in particular, were not able to use beta-carotene for the synthesis of retinol) and that no safety concerns would arise for users. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment beta-carotene shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment beta-carotene shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

| (6) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet new requirements resulting from the authorisation. |
| --- | --- |

(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet new requirements resulting from the authorisation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 29 January 2016 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 29 July 2016 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 29 July 2017 in accordance with the rules applicable before 29 July 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

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, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  EFSA Journal 2012;10(6):2737.

3

EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect |
| 3a160(a) | | Beta-carotene | Additive composition

  Beta-carotene.
  Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive.

  Characterisation of the active substance

  Beta-carotene
  C40H56

  CAS number: 7235-40-7
  Beta-carotene, solid form, produced by fermentation or chemical synthesis.
  Strains used in the fermentation:

  Blakeslea trispora Thaxter slant XCPA 07-05-1 (CGMCC (1) 7.44) and XCPA 07-05-2 (CGMCC 7.45).
  Purity criteria:






  — | (assay) min. 96 % total colouring matters (dried substance) expressed as beta-carotene, |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Category of nutritional additives. Functional group: vitamins, provitamins and chemically well defined substances having a similar effect

3a160(a)

Beta-carotene

Additive composition

Beta-carotene.

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg of the additive.

Characterisation of the active substance

Beta-carotene

C40H56

CAS number: 7235-40-7

Beta-carotene, solid form, produced by fermentation or chemical synthesis.

Strains used in the fermentation:

Blakeslea trispora Thaxter slant XCPA 07-05-1 (CGMCC (1) 7.44) and XCPA 07-05-2 (CGMCC 7.45).

Purity criteria:

—

(assay) min. 96 % total colouring matters (dried substance) expressed as beta-carotene,

| — | carotenoids other than beta-carotene ≤ 3 % of total colouring matters. |
| --- | --- |

—

carotenoids other than beta-carotene ≤ 3 % of total colouring matters.

Method of Analysis
   (2)

For the determination of Beta- carotene in the feed additive: spectrophotometric method based on the European Pharmacopoeia (Ph. Eur. monograph 1069).

For the determination of Beta-carotene in premixtures and feedingstuffs: Reverse Phase High Performance Liquid Chromatography (RP-HPLC) coupled to UV detector.

All animal species

—

—

| 1. | Beta-carotene may be placed on the market and used as an additive consisting of a preparation. |
| --- | --- |

1.

Beta-carotene may be placed on the market and used as an additive consisting of a preparation.

| 2. | In milk replacers for calves it is recommended a maximum content of 50 mg of beta-carotene/kg of milk replacer. |
| --- | --- |

2.

In milk replacers for calves it is recommended a maximum content of 50 mg of beta-carotene/kg of milk replacer.

| 3. | In the directions for use of the additive and premixture, indicate storage and stability conditions. |
| --- | --- |

3.

In the directions for use of the additive and premixture, indicate storage and stability conditions.

| 4. | For safety: breathing protection shall be worn during handling. |
| --- | --- |

4.

For safety: breathing protection shall be worn during handling.

29 July 2025

---

(1)  China General Microbiological Culture Collection Centre.

(2)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/61 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/61

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1104

of 8 July 2015

amending Implementing Regulation (EU) No 237/2012 as regards a new form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) (holder of authorisation Kerry Ingredients and Flavours)

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | The use of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) was authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012 (2), and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013 (3). |
| --- | --- |

(2)

The use of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) was authorised for 10 years for chickens for fattening by Commission Implementing Regulation (EU) No 237/2012 (2), and for minor poultry species for fattening and for chickens reared for laying by Commission Implementing Regulation (EU) No 1365/2013 (3).

| (3) | In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation to include a liquid form of alpha-galactosidase and endo-1,4-beta-glucanase to be used as a feed additive for chickens for fattening. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’). |
| --- | --- |

(3)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation to include a liquid form of alpha-galactosidase and endo-1,4-beta-glucanase to be used as a feed additive for chickens for fattening. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (‘the Authority’).

| (4) | The Authority concluded in its opinion of 28 October 2014 (4) that the liquid form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The Authority concluded in its opinion of 28 October 2014 (4) that the liquid form of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that it has a potential to favourably affect animal performance in chickens for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the existing authorisation should be modified in order to include the new form. |
| --- | --- |

(5)

The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the existing authorisation should be modified in order to include the new form.

| (6) | Therefore, the Annex to Implementing Regulation (EU) No 237/2012 should be amended accordingly. |
| --- | --- |

(6)

Therefore, the Annex to Implementing Regulation (EU) No 237/2012 should be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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 Implementing Regulation (EU) No 237/2012 is replaced by the text set out in the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Commission Implementing Regulation (EU) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours) (OJ L 80, 20.3.2012, p. 1).

2

Saccharomyces cerevisiae

Aspergillus niger

(3)  Commission Implementing Regulation (EU) No 1365/2013 of 18 December 2013 concerning the authorisation of a preparation of alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604) as a feed additive for minor poultry species for fattening and for chickens reared for laying (holder of authorisation Kerry Ingredients and Flavours (OJ L 343, 19.12.2013, p. 31).

3

Saccharomyces cerevisiae

Aspergillus niger

(4)  EFSA Journal 2014; 12(11):3897.

4

EFSA Journal

---

ANNEX

‘ANNEX

| Identi-fication number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a17 | Kerry ingredients and flavors | Alpha-galactosidase
  EC 3.2.1.22
  Endo-1,4-beta-glucanase
  EC 3.2.1.4 | Additive composition

  Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of: | Solid form:






  — | 1 000 U (1) alpha-galactosidase/g |

Identi-fication number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a17

Kerry ingredients and flavors

Alpha-galactosidase

EC 3.2.1.22

Endo-1,4-beta-glucanase

EC 3.2.1.4

Additive composition

Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) with a minium activiy of:

Solid form:

—

1 000 U (1) alpha-galactosidase/g

| — | 5 700 U (2) endo-1,4- beta-glucanase/g |
| --- | --- |

—

5 700 U (2) endo-1,4- beta-glucanase/g

| | Liquid form:






  — | 500 U alpha-galactosidase/g |
| --- | --- | --- |

Liquid form:

—

500 U alpha-galactosidase/g

| — | 2 850 U endo-1,4- beta-glucanase/g. |
| --- | --- |

—

2 850 U endo-1,4- beta-glucanase/g.

Characterisation of the active substance

Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604).

Method of Analysis
   (3)

Determination:

| — | Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate, |
| --- | --- |

—

Alpha-galactosidase: colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,

| — | endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate. |
| --- | --- |

—

endo-1,4-beta-glucanase: colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

Chickens for fattening

—

50 U alpha-galactosidase

285 U endo-1,4-beta-glucanase

—

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | Maximum recommended dose:






  — | 100 U alpha-galactosidase/kg; |
| --- | --- | --- |

2.

Maximum recommended dose:

—

100 U alpha-galactosidase/kg;

| — | 570 U endo-1,4-beta-glucanase/kg. |
| --- | --- |

—

570 U endo-1,4-beta-glucanase/kg.

| 3. | For safety: breathing protection glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection glasses and gloves shall be used during handling.

9 April 2022

---

(1)  1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.

1

(2)  1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.

2

(3)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports’

3

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/65 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/65

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1105

of 8 July 2015

concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, the authorisation of that feed additive for use in water for drinking for chickens for fattening and amending Regulation (EU) No 544/2013 as regards the maximum content of that feed additive in complete feedingstuff and its compatibility with coccidiostats (holder of the authorisation Biomin GmbH)

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1) , and in particular Article 9(2) and Article 13(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 544/2013 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 and for an amendment of the terms of the current authorisation for chickens for fattening granted by Commission Implementing Regulation (EU) No 544/2013 (2). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to support that amendment request.

| (3) | The application concerns the authorisation of a new use of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, to be classified in the additive category ‘zootechnical additives’, the authorisation of a new use of that preparation via water for drinking for chickens for fattening and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats: decoquinate, narasin, nicarbazin or narasin/nicarbazin, and to remove the limit for the maximum content of that preparation in complete feedingstuff. |
| --- | --- |

(3)

The application concerns the authorisation of a new use of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens reared for laying and minor poultry species other than laying, to be classified in the additive category ‘zootechnical additives’, the authorisation of a new use of that preparation via water for drinking for chickens for fattening and the modification of the terms of the current authorisation for chickens for fattening to allow simultaneous use with the additional coccidiostats: decoquinate, narasin, nicarbazin or narasin/nicarbazin, and to remove the limit for the maximum content of that preparation in complete feedingstuff.

| (4) | The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 544/2013. |
| --- | --- |

(4)

The use of that preparation was authorised for 10 years for chickens for fattening by Commission Regulation (EU) No 544/2013.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 December 2014 (3) that, under the proposed conditions of use, the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 does not have an adverse effect on animal health, human health and the environment and has the potential to be efficacious when used in chickens reared for laying and minor poultry species other than laying. The Authority also concluded that delivery of the additive via water for drinking is as safe for chickens for fattening as delivery via feed and that there would be no safety implications if the current maximum dose for chickens for fattening were withdrawn. The conclusions on safety for chickens for fattening, as regards delivery via water for drinking and maximum dose, would also apply to chickens reared for laying and minor avian species. The Authority further concluded that the additive is compatible with the coccidiostats decoquinate, narasin, nicarbazin or narasin/nicarbazin. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 9 December 2014 (3) that, under the proposed conditions of use, the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 does not have an adverse effect on animal health, human health and the environment and has the potential to be efficacious when used in chickens reared for laying and minor poultry species other than laying. The Authority also concluded that delivery of the additive via water for drinking is as safe for chickens for fattening as delivery via feed and that there would be no safety implications if the current maximum dose for chickens for fattening were withdrawn. The conclusions on safety for chickens for fattening, as regards delivery via water for drinking and maximum dose, would also apply to chickens reared for laying and minor avian species. The Authority further concluded that the additive is compatible with the coccidiostats decoquinate, narasin, nicarbazin or narasin/nicarbazin. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

| (7) | In order to allow for the use of coccidiostats compatible with the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 also for chickens for fattening and to allow for the same content of that preparation in complete feedingstuff for chickens for fattening as for chickens reared for laying and minor poultry species it is appropriate to amend Regulation (EU) No 544/2013. |
| --- | --- |

(7)

In order to allow for the use of coccidiostats compatible with the preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 also for chickens for fattening and to allow for the same content of that preparation in complete feedingstuff for chickens for fattening as for chickens reared for laying and minor poultry species it is appropriate to amend Regulation (EU) No 544/2013.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(8)

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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

The Annex to Regulation (EU) No 544/2013 is amended as follows:

| (1) | In the eighth column, ‘Maximum content’, the text ‘1 × 109’ is deleted. |
| --- | --- |

(1)

In the eighth column, ‘Maximum content’, the text ‘1 × 109’ is deleted.

| (2) | In the ninth column, ‘Other provisions’, paragraph 2 is replaced by the following:






  ‘2. | The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.’ |
| --- | --- | --- |

(2)

In the ninth column, ‘Other provisions’, paragraph 2 is replaced by the following:

‘2.

The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.’

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, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Commission Implementing Regulation (EU) No 544/2013 of 14 June 2013 concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH) (OJ L 163, 15.6.2013, p. 13).

2

Bifidobacterium animalis

animalis DSM 16284, Lactobacillus salivarius

salivarius DSM 16351

Enterococcus faecium DSM 21913

(3)  EFSA Journal 2015; 13(1):3966.

3

EFSA Journal

---

ANNEX

PART A

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU (1)/kg of complete feedingstuff with a moisture content of 12 % | CFU (1) l of water for drinking |
| Category of zootechnical additives. Functional group: gut flora stabilisers. |
| 4b1890 | Biomin GmbH | Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 | Additive composition

  Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

  Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

  Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive
  Solid preparation (ratio 3:1:6)

  Characterisation of the active substance

  Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913

  Analytical method
   (2)

  For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE) | Chickens reared for laying, minor poultry species other than laying | | 1 × 108 | — | 5 × 107 | — | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU (1)/kg of complete feedingstuff with a moisture content of 12 %

CFU (1) l of water for drinking

Category of zootechnical additives. Functional group: gut flora stabilisers.

4b1890

Biomin GmbH

Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913

Additive composition

Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive

Solid preparation (ratio 3:1:6)

Characterisation of the active substance

Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913

Analytical method
   (2)

For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)

Chickens reared for laying, minor poultry species other than laying

1 × 108

—

5 × 107

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

| 2. | The use is permitted in feed containing the following coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin. |
| --- | --- |

2.

The use is permitted in feed containing the following coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.

| 3. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

| 4. | The additive may be used also via water for drinking. |
| --- | --- |

4.

The additive may be used also via water for drinking.

| 5. | For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured. |
| --- | --- |

5.

For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured.

| 6. | The simultaneous use with antibiotic shall be avoided. |
| --- | --- |

6.

The simultaneous use with antibiotic shall be avoided.

29 July 2025

PART B

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU (3)/l of water for drinking |
| |
| 4b1890 | Biomin GmbH | Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 | Additive composition

  Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

  Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

  Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive
  Solid preparation (ratio 3:1:6)

  Characterisation of the active substance

  Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913

  Analytical method
   (4)

  For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE) | Chickens for fattening | — | 5 × 107 | — | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU (3)/l of water for drinking

4b1890

Biomin GmbH

Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913

Additive composition

Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive

Solid preparation (ratio 3:1:6)

Characterisation of the active substance

Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351, and Enterococcus faecium DSM 21913

Analytical method
   (4)

For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)

Chickens for fattening

—

5 × 107

—

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

| 2. | The water for drinking containing the additive may be used simultaneously with feed containing the following permitted coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin. |
| --- | --- |

2.

The water for drinking containing the additive may be used simultaneously with feed containing the following permitted coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.

| 3. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

| 4. | The homogeneous dispersion of the additive shall be ensured in the water for drinking. |
| --- | --- |

4.

The homogeneous dispersion of the additive shall be ensured in the water for drinking.

| 5. | The simultaneous use with antibiotic shall be avoided. |
| --- | --- |

5.

The simultaneous use with antibiotic shall be avoided.

29 July 2025

---

(1)  As total content of the mixture.

(2)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(3)  As total content of the mixture.

(4)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/70 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/70

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1106

of 8 July 2015

amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the second alternative of Article 21(3) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) No 1037/2012 (2) approved isopyrazam as active substance in accordance with Regulation (EC) No 1107/2009, provided that the applicant for approval, Syngenta Crop Protection AG (‘the applicant’), submits confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater, and listed it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). The confirmatory information was to be submitted to the Commission, the Member States and the European Food Safety Authority (‘the Authority’) by 31 March 2015. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) No 1037/2012 (2) approved isopyrazam as active substance in accordance with Regulation (EC) No 1107/2009, provided that the applicant for approval, Syngenta Crop Protection AG (‘the applicant’), submits confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater, and listed it in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). The confirmatory information was to be submitted to the Commission, the Member States and the European Food Safety Authority (‘the Authority’) by 31 March 2015.

| (2) | In February 2014, the applicant informed the Commission that it was expected that not all the confirmatory information required would be available by the deadline set out in Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012. The applicant stated that this delay was due to the need to develop appropriate testing protocols and submitted a working plan for the generation of that information. |
| --- | --- |

(2)

In February 2014, the applicant informed the Commission that it was expected that not all the confirmatory information required would be available by the deadline set out in Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012. The applicant stated that this delay was due to the need to develop appropriate testing protocols and submitted a working plan for the generation of that information.

| (3) | The United Kingdom as the rapporteur Member State for isopyrazam assessed the information submitted by the applicant and informed the Commission in September 2014 that it considered the request of the applicant to extend the deadline for the submission of confirmatory information to be reasoned and that the working plan submitted by the applicant is realistic and appropriate. |
| --- | --- |

(3)

The United Kingdom as the rapporteur Member State for isopyrazam assessed the information submitted by the applicant and informed the Commission in September 2014 that it considered the request of the applicant to extend the deadline for the submission of confirmatory information to be reasoned and that the working plan submitted by the applicant is realistic and appropriate.

| (4) | Therefore, it appears that the request is justified in order to allow the applicant to generate the necessary data within a reasonable timeline. |
| --- | --- |

(4)

Therefore, it appears that the request is justified in order to allow the applicant to generate the necessary data within a reasonable timeline.

| (5) | On 30 March 2015, the applicant submitted a summary document reporting the information generated so far and setting out a final working plan for the generation of the outstanding information. |
| --- | --- |

(5)

On 30 March 2015, the applicant submitted a summary document reporting the information generated so far and setting out a final working plan for the generation of the outstanding information.

| (6) | It is therefore appropriate to amend the approval of isopyrazam and extend the deadline for the submission of confirmatory information until 31 July 2017. |
| --- | --- |

(6)

It is therefore appropriate to amend the approval of isopyrazam and extend the deadline for the submission of confirmatory information until 31 July 2017.

| (7) | Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 should therefore be amended accordingly. |
| --- | --- |

(7)

Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 should therefore be amended accordingly.

| (8) | Given the fact that the deadline for submitting confirmatory information related to isopyrazam has already expired, this Regulation should enter into force on the day following that of its publication. |
| --- | --- |

(8)

Given the fact that the deadline for submitting confirmatory information related to isopyrazam has already expired, this Regulation should enter into force on the day following that of its publication.

| (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

Amendments to Implementing Regulation (EU) No 540/2011

In the column ‘Specific provisions’ of row 27, isopyrazam, of Part B of the Annex to Implementing Regulation (EU) No 540/2011, the last paragraph is replaced by the following:

‘The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.’

Article 2

Amendments to Implementing Regulation (EU) No 1037/2012

In the column ‘Specific provisions’ of the Annex to Implementing Regulation (EU) No 1037/2012, the last paragraph is replaced by the following:

‘The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.’

Article 3

Entry into force

This Regulation shall enter into force on the 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, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Implementing Regulation (EU) No 1037/2012 of 7 November 2012 approving the active substance isopyrazam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 308, 8.11.2012, p. 15).

2

(3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

3

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/72 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/72

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1107

of 8 July 2015

approving the basic substance Salix spp. cortex, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 23(5) in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Salix alba bark as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3). |
| --- | --- |

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Salix alba bark as basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3).

| (2) | The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 3 June 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 14 November 2014 and finalised them for the meeting of that Committee of 29 May 2015. |
| --- | --- |

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 3 June 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 14 November 2014 and finalised them for the meeting of that Committee of 29 May 2015.

| (3) | The documentation provided by the applicant and the results of examination carried out by the European Medicine Agency (4) in accordance with Directive 2001/83/EC of the European Parliament and of the Council (5) show that Salix cortex fulfils the criteria of a traditional herbal medicine. It was therefore considered appropriate to extend the scope of the application from Salix alba bark to Salix spp. cortex. Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. |
| --- | --- |

(3)

The documentation provided by the applicant and the results of examination carried out by the European Medicine Agency (4) in accordance with Directive 2001/83/EC of the European Parliament and of the Council (5) show that Salix cortex fulfils the criteria of a traditional herbal medicine. It was therefore considered appropriate to extend the scope of the application from Salix alba bark to Salix spp. cortex. Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water.

| (4) | The Commission considers that Salix spp. cortex is a basic substance pursuant to Article 23 of Regulation (EC) No 1107/2009. Salix spp. cortex is part of a plant and is ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses as detailed in the review report is expected to be negligible compared to exposure expected through realistic natural situations. |
| --- | --- |

(4)

The Commission considers that Salix spp. cortex is a basic substance pursuant to Article 23 of Regulation (EC) No 1107/2009. Salix spp. cortex is part of a plant and is ubiquitous in the environment. The additional exposure of humans, animals and the environment by the uses as detailed in the review report is expected to be negligible compared to exposure expected through realistic natural situations.

| (5) | Therefore, Salix spp. cortex may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Salix spp. cortex as a basic substance. |
| --- | --- |

(5)

Therefore, Salix spp. cortex may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Salix spp. cortex as a basic substance.

| (6) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation. |
| --- | --- |

(6)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation.

| (7) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly. |
| --- | --- |

(7)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(8)

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

Approval of a basic substance

The substance Salix spp. cortex as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Outcome of the consultation with Member States and EFSA on the basic substance application for Salix alba bark and the conclusions drawn by EFSA on the specific points raised. 2014:EN-609.34 pp.

2

Salix alba

(3)  http://ec.europa.eu/sanco_pesticides/public/?event=homepage

3

(4)  Assessment report on Salicis cortex (willow bark) and herbal preparation(s) thereof with well-established use and traditional use; EMEA/HMPC/295337/2007.

4

(5)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

5

(6)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

6

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
| --- | --- | --- | --- | --- |
| Salix spp. cortex
  CAS No: not allocated
  CIPAC No: not allocated | Not applicable | European Pharmacopeia | 1 July 2015 | Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Specific provisions

Salix spp. cortex

CAS No: not allocated

CIPAC No: not allocated

Not applicable

European Pharmacopeia

1 July 2015

Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.

---

(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

---

ANNEX II

In Part C of the Annex to Implementing Regulation (EC) No 540/2011, the following entry is added:

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| ‘7 | Salix spp. cortex
  CAS No: not allocated
  CIPAC No: not allocated | Not applicable | European Pharmacopeia | 1 July 2015 | Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.’ |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Specific provisions

‘7

Salix spp. cortex

CAS No: not allocated

CIPAC No: not allocated

Not applicable

European Pharmacopeia

1 July 2015

Salix cortex shall be used in accordance with the specific conditions included in the conclusions of the review report on Salix spp. cortex (SANCO/12173/2014) and in particular Appendices I and II thereof.’

---

(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

1

---

| 9.7.2015 | EN | Official Journal of the European Union | L 181/75 |
| --- | --- | --- | --- |

9.7.2015

EN

Official Journal of the European Union

L 181/75

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1108

of 8 July 2015

approving the basic substance vinegar in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 23(5) in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 24 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of vinegar as basic substance. On 17 March 2014 an application from the city of Paris (France) was received to extend the intended uses covered by the application for the approval of vinegar as basic substance. Those applications were accompanied by the information required by the second subparagraph of Article 23(3). |
| --- | --- |

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 24 April 2013 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of vinegar as basic substance. On 17 March 2014 an application from the city of Paris (France) was received to extend the intended uses covered by the application for the approval of vinegar as basic substance. Those applications were accompanied by the information required by the second subparagraph of Article 23(3).

| (2) | The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 12 August 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015 and finalised them for the meeting of that Committee of 29 May 2015. |
| --- | --- |

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 12 August 2014 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015 and finalised them for the meeting of that Committee of 29 May 2015.

| (3) | The documentation provided by the applicant shows that vinegar fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. In particular, vinegar should not be confused with acetic acid, an active substance which was included in Annex I to Council Directive 91/414/EEC (5) by Commission Directive 2008/127/EC (6), as clarified in the Commission interpretative communication (7) on the names under which foodstuffs are sold. Consequently, vinegar is to be considered as a basic substance. |
| --- | --- |

(3)

The documentation provided by the applicant shows that vinegar fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. In particular, vinegar should not be confused with acetic acid, an active substance which was included in Annex I to Council Directive 91/414/EEC (5) by Commission Directive 2008/127/EC (6), as clarified in the Commission interpretative communication (7) on the names under which foodstuffs are sold. Consequently, vinegar is to be considered as a basic substance.

| (4) | It has appeared from the examinations made that vinegar may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve vinegar as a basic substance. |
| --- | --- |

(4)

It has appeared from the examinations made that vinegar may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve vinegar as a basic substance.

| (5) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation. |
| --- | --- |

(5)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions for the approval which are detailed in Annex I to this Regulation.

| (6) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (8) should be amended accordingly. |
| --- | --- |

(6)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (8) should be amended accordingly.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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

Approval of a basic substance

The substance vinegar as specified in Annex I is approved as basic substance subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

Part C of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Outcome of the consultation with Member States and EFSA on the basic substance application for vinegar and the conclusions drawn by EFSA on the specific points raised. EFSA supporting publication 2014:EN-641.37 pp.

2

(3)  http://ec.europa.eu/sanco_pesticides/public/?event=homepage

3

(4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

4

(5)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

5

(6)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

6

(7)  OJ C 270, 15.10.1991, p. 2.

7

(8)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

8

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
| --- | --- | --- | --- | --- |
| Vinegar
  CAS No: 90132-02-8 | Not available | Food grade containing a maximum of 10 % acetic acid | 1 July 2015 | Only uses as basic substance being a fungicide and bactericide are approved.
  Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Specific provisions

Vinegar

CAS No: 90132-02-8

Not available

Food grade containing a maximum of 10 % acetic acid

1 July 2015

Only uses as basic substance being a fungicide and bactericide are approved.

Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.

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(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

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ANNEX II

In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| ‘5 | Vinegar
  CAS No: 90132-02-8 | Not available | Food grade containing a maximum of 10 % acetic acid. | 1 July 2015 | Only uses as basic substance being a fungicide and bactericide are approved.
  Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.’ |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Specific provisions

‘5

Vinegar

CAS No: 90132-02-8

Not available

Food grade containing a maximum of 10 % acetic acid.

1 July 2015

Only uses as basic substance being a fungicide and bactericide are approved.

Vinegar shall be used in accordance with the specific conditions included in the conclusions of the review report on vinegar (SANCO/12896/2014) and in particular Appendices I and II thereof.’

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(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

1

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| 9.7.2015 | EN | Official Journal of the European Union | L 181/78 |
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9.7.2015

EN

Official Journal of the European Union

L 181/78

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1109

of 8 July 2015

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 July 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

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(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  OJ L 157, 15.6.2011, p. 1.

2

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ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | AL | 20,6 |
| MA | 172,4 |
| MK | 51,7 |
| ZZ | 81,6 |
| 0707 00 05 | TR | 116,3 |
| ZZ | 116,3 |
| 0709 93 10 | TR | 119,1 |
| ZZ | 119,1 |
| 0805 50 10 | AR | 108,2 |
| TR | 108,0 |
| UY | 129,3 |
| ZA | 150,8 |
| ZZ | 124,1 |
| 0808 10 80 | AR | 97,8 |
| BR | 106,5 |
| CL | 133,5 |
| NZ | 118,6 |
| US | 121,0 |
| ZA | 120,9 |
| ZZ | 116,4 |
| 0808 30 90 | AR | 109,3 |
| CL | 144,1 |
| CN | 86,2 |
| NZ | 235,9 |
| ZA | 127,5 |
| ZZ | 140,6 |
| 0809 10 00 | TR | 236,9 |
| ZZ | 236,9 |
| 0809 29 00 | TR | 258,6 |
| ZZ | 258,6 |
| 0809 30 10, 0809 30 90 | CL | 181,4 |
| ZZ | 181,4 |
| 0809 40 05 | CL | 126,8 |
| ZZ | 126,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

AL

20,6

MA

172,4

MK

51,7

ZZ

81,6

0707 00 05

TR

116,3

ZZ

116,3

0709 93 10

TR

119,1

ZZ

119,1

0805 50 10

AR

108,2

TR

108,0

UY

129,3

ZA

150,8

ZZ

124,1

0808 10 80

AR

97,8

BR

106,5

CL

133,5

NZ

118,6

US

121,0

ZA

120,9

ZZ

116,4

0808 30 90

AR

109,3

CL

144,1

CN

86,2

NZ

235,9

ZA

127,5

ZZ

140,6

0809 10 00

TR

236,9

ZZ

236,9

0809 29 00

TR

258,6

ZZ

258,6

0809 30 10, 0809 30 90

CL

181,4

ZZ

181,4

0809 40 05

CL

126,8

ZZ

126,8

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(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

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| 9.7.2015 | EN | Official Journal of the European Union | L 181/80 |
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9.7.2015

EN

Official Journal of the European Union

L 181/80

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1110

of 8 July 2015

establishing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 26 June to 3 July 2015 in the context of the tariff quota for maize opened by Regulation (EC) No 969/2006

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 188(1) and (3) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 969/2006 (2) opened an annual import tariff quota of 277 988 tonnes of maize (order number 09.4131). |
| --- | --- |

(1)

Commission Regulation (EC) No 969/2006 (2) opened an annual import tariff quota of 277 988 tonnes of maize (order number 09.4131).

| (2) | Article 2(1) of Regulation (EC) No 969/2006 fixes a quantity of 138 994 tonnes for subperiod 2 from 1 July to 31 December 2015. |
| --- | --- |

(2)

Article 2(1) of Regulation (EC) No 969/2006 fixes a quantity of 138 994 tonnes for subperiod 2 from 1 July to 31 December 2015.

| (3) | The quantities covered by the applications for import licences lodged from 26 June 2015 at 13.00 to 3 July 2015 at 13.00 (Brussels time) exceed those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3). |
| --- | --- |

(3)

The quantities covered by the applications for import licences lodged from 26 June 2015 at 13.00 to 3 July 2015 at 13.00 (Brussels time) exceed those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

| (4) | Import licences should no longer be issued under Regulation (EC) No 969/2006 for the current quota period. |
| --- | --- |

(4)

Import licences should no longer be issued under Regulation (EC) No 969/2006 for the current quota period.

| (5) | In order to ensure the efficiency of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(5)

In order to ensure the efficiency of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The quantities covered by the applications for import licences in respect of the quota referred to in Article 2(1) of Regulation (EC) No 969/2006 (order number 09.4131) lodged from 26 June 2015 at 13.00 to 3 July 2015 at 13.00 (Brussels time) shall be multiplied by an allocation coefficient of 77,459146 %.

2.   The submission of new import licence applications in respect of the quota referred to in Article 2(1) of Regulation (EC) No 969/2006 (order number 09.4131) is suspended as from 3 July 2015 at 13.00 (Brussels time) for the current quota subperiod.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 July 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

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(1)  OJ L 347, 20.12.2013, p. 671.

1

(2)  Commission Regulation (EC) No 969/2006 of 29 June 2006 opening and providing for the administration of a Community tariff quota for imports of maize from third countries (OJ L 176, 30.6.2006, p. 44).

2

(3)  Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (OJ L 238, 1.9.2006, p. 13).

3

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DECISIONS

| 9.7.2015 | EN | Official Journal of the European Union | L 181/82 |
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9.7.2015

EN

Official Journal of the European Union

L 181/82

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COMMISSION IMPLEMENTING DECISION (EU) 2015/1111

of 7 July 2015

on the compliance of the joint proposal submitted by the Member States concerned for the extension of the North Sea-Baltic rail freight corridor with Article 5 of Regulation (EU) No 913/2010 of the European Parliament and of the Council concerning a European rail network for competitive freight

(notified under document C(2015) 4507)

(Only the Czech, Dutch, French, German, Lithuanian and Polish texts are authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 913/2010 of the European Parliament and of the Council of 22 September 2010 concerning a European rail network for competitive freight (1), and in particular Article 5(6) thereof,

Whereas:

| (1) | In accordance with Article 5(5) of Regulation (EU) No 913/2010, the ministries responsible for rail transport in Belgium, the Czech Republic, Germany, Lithuania, the Netherlands and Poland sent the Commission a letter of intent dated 27 April 2014 including a proposal on extensions of the North Sea-Baltic rail freight corridor to the Czech Republic and to the Polish-Ukrainian border. |
| --- | --- |

(1)

In accordance with Article 5(5) of Regulation (EU) No 913/2010, the ministries responsible for rail transport in Belgium, the Czech Republic, Germany, Lithuania, the Netherlands and Poland sent the Commission a letter of intent dated 27 April 2014 including a proposal on extensions of the North Sea-Baltic rail freight corridor to the Czech Republic and to the Polish-Ukrainian border.

| (2) | The Commission examined this proposal pursuant to Article 5(6) of Regulation (EU) No 913/2010, and considers it to be compliant with Article 5 of that Regulation. In particular, the results of the transport market study on the North Sea-Baltic rail freight corridor carried out by the management board of the corridor show there to be significant potential for a further increase in traffic between major North Sea ports and both the Czech Republic and southern Poland, especially from combined transport. Moreover, the proposed extensions offer the advantage of creating a ‘one-stop shop’ (as described in Article 13 of Regulation (EU) No 913/2010) for managing infrastructure capacity along the freight corridors between North Sea ports and, respectively, the Czech Republic and southern Poland. Furthermore, the proposed extensions are consistent with the design proposed for Corridor F in the European Rail Traffic Management System (ERTMS) European deployment plan, as set out in Commission Decision 2012/88/EU (2). The proposed extensions also improve the overall interconnectedness of the rail freight corridors set up to form a European rail network for competitive freight, in particular by providing a direct connection between the North Sea-Baltic rail freight corridor and the Rhine-Danube corridor in the Czech Republic. Finally, the proposed extensions may potentially improve rail traffic across the EU eastern border and on the Europe-Asia land bridge. |
| --- | --- |

(2)

The Commission examined this proposal pursuant to Article 5(6) of Regulation (EU) No 913/2010, and considers it to be compliant with Article 5 of that Regulation. In particular, the results of the transport market study on the North Sea-Baltic rail freight corridor carried out by the management board of the corridor show there to be significant potential for a further increase in traffic between major North Sea ports and both the Czech Republic and southern Poland, especially from combined transport. Moreover, the proposed extensions offer the advantage of creating a ‘one-stop shop’ (as described in Article 13 of Regulation (EU) No 913/2010) for managing infrastructure capacity along the freight corridors between North Sea ports and, respectively, the Czech Republic and southern Poland. Furthermore, the proposed extensions are consistent with the design proposed for Corridor F in the European Rail Traffic Management System (ERTMS) European deployment plan, as set out in Commission Decision 2012/88/EU (2). The proposed extensions also improve the overall interconnectedness of the rail freight corridors set up to form a European rail network for competitive freight, in particular by providing a direct connection between the North Sea-Baltic rail freight corridor and the Rhine-Danube corridor in the Czech Republic. Finally, the proposed extensions may potentially improve rail traffic across the EU eastern border and on the Europe-Asia land bridge.

| (3) | The extension of the North Sea-Baltic rail freight corridor should not impede the development of the Orient/East-Med rail freight corridor, as provided for in the Annex to Regulation (EU) No 913/2010, which also includes a connection between the North Sea ports and the Czech Republic. |
| --- | --- |

(3)

The extension of the North Sea-Baltic rail freight corridor should not impede the development of the Orient/East-Med rail freight corridor, as provided for in the Annex to Regulation (EU) No 913/2010, which also includes a connection between the North Sea ports and the Czech Republic.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 21 of Regulation (EU) No 913/2010, |
| --- | --- |

(4)

The measures provided for in this Decision are in accordance with the opinion of the Committee established pursuant to Article 21 of Regulation (EU) No 913/2010,

HAS ADOPTED THIS DECISION:

Article 1

The letter of intent of 27 April 2014 concerning extensions of the North Sea-Baltic rail freight corridor to the Czech Republic and to the Polish-Ukrainian border, sent to the Commission by the ministries responsible for rail transport in Belgium, the Czech Republic, Germany, Lithuania, the Netherlands and Poland, and proposing the route Wilhelmshaven/Bremerhaven/Hamburg/Amsterdam/Rotterdam/Antwerpen-Aachen-Hannover/Berlin-Warsaw-Terespol (Poland-Belarus border)/Kaunas-Riga-Tallinn/Falkenberg-Prague/Wroclaw-Katowice-Medyka (Poland-Ukraine border) as the principal route for the North Sea-Baltic rail freight corridor is compliant with Article 5 of Regulation (EU) No 913/2010.

Article 2

This Decision is addressed to the Kingdom of Belgium, the Czech Republic, the Federal Republic of Germany, the Republic of Lithuania, the Kingdom of the Netherlands and the Republic of Poland.

Done at Brussels, 7 July 2015.

For the Commission

Violeta BULC

Member of the Commission

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(1)  OJ L 276, 20.10.2010, p. 22.

1

(2)  Commission Decision 2012/88/EU of 25 January 2012 on the technical specification for interoperability relating to the control-command and signalling subsystems of the trans-European rail system (OJ L 51, 23.2.2012, p. 1).

2

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Corrigenda

| 9.7.2015 | EN | Official Journal of the European Union | L 181/84 |
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9.7.2015

EN

Official Journal of the European Union

L 181/84

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Corrigendum to Council Directive 2001/23/EC of 12 March 2001 on the approximation of the laws of the Member States relating to the safeguarding of employees' rights in the event of transfers of undertakings, businesses or parts of undertakings or businesses

(
  Official Journal of the European Communities L 82 of 22 March 2001
  )

On page 18, Article 6(1), second subparagraph, first line:

for:

‘The first subparagraph shall not supply if, under the laws, ...’,

read:

‘The first subparagraph shall not apply if, under the laws, ...’.

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