# Official Journal L 279/2019

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 279 |
| | |
| English edition | Legislation | Volume 6231 October 2019 |

ISSN 1977-0677

Official Journal

of the European Union

L 279

English edition

Legislation

Volume 6231 October 2019

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2019/1819 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include vinegar as an active substance in Annex I thereto (
  1
  ) | 1 |
| | * | Commission Delegated Regulation (EU) 2019/1820 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include Saccharomyces cerevisiae as an active substance in Annex I thereto (
  1
  ) | 4 |
| | * | Commission Delegated Regulation 2019/1821 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include powdered egg as an active substance in Annex I thereto (
  1
  ) | 7 |
| | * | Commission Delegated Regulation (EU) 2019/1822 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include honey as an active substance in Annex I thereto (
  1
  ) | 10 |
| | * | Commission Delegated Regulation (EU) 2019/1823 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include D-fructose as an active substance in Annex I thereto (
  1
  ) | 13 |
| | * | Commission Delegated Regulation (EU) 2019/1824 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include cheese as an active substance in Annex I thereto (
  1
  ) | 16 |
| | * | Commission Delegated Regulation (EU) 2019/1825 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include concentrated apple juice as an active substance in Annex I thereto (
  1
  ) | 19 |
| | * | Commission Implementing Regulation (EU) 2019/1826 of 25 October 2019 entering a name in the register of protected designations of origin and protected geographical indications (Kaimiškas Jovarų alus (PGI)) | 22 |
| | * | Commission Delegated Regulation (EU) 2019/1827 of 30 October 2019 amending Directive 2014/23/EU of the European Parliament and of the Council in respect of the threshold for concessions (
  1
  ) | 23 |
| | * | Commission Delegated Regulation (EU) 2019/1828 of 30 October 2019 amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the thresholds for public supply, service and works contracts, and design contests (
  1
  ) | 25 |
| | * | Commission Delegated Regulation (EU) 2019/1829 of 30 October 2019 amending Directive 2014/25/EU of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts, and design contests (
  1
  ) | 27 |
| | * | Commission Delegated Regulation (EU) 2019/1830 of 30 October 2019 amending Directive 2009/81/EC of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts (
  1
  ) | 29 |
| | | DIRECTIVES |
| | * | Commission Directive (EU) 2019/1831 of 24 October 2019 establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Commission Directive 2000/39/EC (
  1
  ) | 31 |
| | * | Commission Directive 2019/1832 of 24 October 2019 amending Annexes I, II and III to Council Directive 89/656/EEC as regards purely technical adjustments | 35 |
| | * | Commission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments | 54 |
| | * | Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations | 80 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2019/1835 of 30 October 2019 excluding from European Union financing certain expenditure incurred by the Member States under the European Agricultural Guarantee Fund (EAGF) and under the European Agricultural Fund for Rural Development (EAFRD)
  (notified under document C(2019) 7815) | 98 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2019/1819 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include vinegar as an active substance in Annex I thereto (
  1
  )

1

1

*

Commission Delegated Regulation (EU) 2019/1820 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include Saccharomyces cerevisiae as an active substance in Annex I thereto (
  1
  )

Saccharomyces cerevisiae

1

4

*

Commission Delegated Regulation 2019/1821 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include powdered egg as an active substance in Annex I thereto (
  1
  )

1

7

*

Commission Delegated Regulation (EU) 2019/1822 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include honey as an active substance in Annex I thereto (
  1
  )

1

10

*

Commission Delegated Regulation (EU) 2019/1823 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include D-fructose as an active substance in Annex I thereto (
  1
  )

1

13

*

Commission Delegated Regulation (EU) 2019/1824 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include cheese as an active substance in Annex I thereto (
  1
  )

1

16

*

Commission Delegated Regulation (EU) 2019/1825 of 8 August 2019 amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include concentrated apple juice as an active substance in Annex I thereto (
  1
  )

1

19

*

Commission Implementing Regulation (EU) 2019/1826 of 25 October 2019 entering a name in the register of protected designations of origin and protected geographical indications (Kaimiškas Jovarų alus (PGI))

22

*

Commission Delegated Regulation (EU) 2019/1827 of 30 October 2019 amending Directive 2014/23/EU of the European Parliament and of the Council in respect of the threshold for concessions (
  1
  )

1

23

*

Commission Delegated Regulation (EU) 2019/1828 of 30 October 2019 amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the thresholds for public supply, service and works contracts, and design contests (
  1
  )

1

25

*

Commission Delegated Regulation (EU) 2019/1829 of 30 October 2019 amending Directive 2014/25/EU of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts, and design contests (
  1
  )

1

27

*

Commission Delegated Regulation (EU) 2019/1830 of 30 October 2019 amending Directive 2009/81/EC of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts (
  1
  )

1

29

DIRECTIVES

*

Commission Directive (EU) 2019/1831 of 24 October 2019 establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Commission Directive 2000/39/EC (
  1
  )

1

31

*

Commission Directive 2019/1832 of 24 October 2019 amending Annexes I, II and III to Council Directive 89/656/EEC as regards purely technical adjustments

35

*

Commission Directive (EU) 2019/1833 of 24 October 2019 amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments

54

*

Commission Directive (EU) 2019/1834 of 24 October 2019 amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations

80

DECISIONS

*

Commission Implementing Decision (EU) 2019/1835 of 30 October 2019 excluding from European Union financing certain expenditure incurred by the Member States under the European Agricultural Guarantee Fund (EAGF) and under the European Agricultural Fund for Rural Development (EAFRD)
  (notified under document C(2019) 7815)

(notified under document C(2019) 7815)

98

| | | III   Other acts |
| --- | --- | --- |
| | | EUROPEAN ECONOMIC AREA |
| | * | Decision of the Eea Joint Committee No 78/2019 of 29 March 2019 amending Annex IX (Financial services) to the EEA Agreement 2019/1836 | 143 |
| | * | Decision of the EEA Joint Committee No 85/2019 of 29 March 2019 amending Annex IX (Financial services) to the EEA Agreement 2019/1837 | 149 |

III   Other acts

EUROPEAN ECONOMIC AREA

*

Decision of the Eea Joint Committee No 78/2019 of 29 March 2019 amending Annex IX (Financial services) to the EEA Agreement 2019/1836

143

*

Decision of the EEA Joint Committee No 85/2019 of 29 March 2019 amending Annex IX (Financial services) to the EEA Agreement 2019/1837

149

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

---

(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

| 31.10.2019 | EN | Official Journal of the European Union | L 279/1 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/1

---

COMMISSION DELEGATED REGULATION (EU) 2019/1819

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include vinegar as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance vinegar, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance vinegar, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for vinegar for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Vinegar was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for vinegar for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Vinegar was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether vinegar gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether vinegar gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that vinegar does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that vinegar does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include vinegar in Annex I to Regulation (EU) No 528/2012. As vinegar is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Vinegar should be included in that Annex only insofar as it falls within the definition of ‘food’ referred to in point (u) of Article 3(1) of that Regulation and insofar it contains less than 10 % acetic acid. This is consistent with the fact that vinegar only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food. |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include vinegar in Annex I to Regulation (EU) No 528/2012. As vinegar is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Vinegar should be included in that Annex only insofar as it falls within the definition of ‘food’ referred to in point (u) of Article 3(1) of that Regulation and insofar it contains less than 10 % acetic acid. This is consistent with the fact that vinegar only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food.

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to vinegar for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to vinegar for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of vinegar for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Vinegar (*1) | Excluding vinegar that is not food and excluding vinegar that contains more than 10 % acetic acid (whether or not it is food). | CAS No 8028-52-2 |

EC number

Name/group

Restriction

Comment

‘Not available

Vinegar (*1)

Excluding vinegar that is not food and excluding vinegar that contains more than 10 % acetic acid (whether or not it is food).

CAS No 8028-52-2

---

(*1)  The date of approval of vinegar for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/4 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/4

---

COMMISSION DELEGATED REGULATION (EU) 2019/1820

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include Saccharomyces cerevisiae as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance Saccharomyces cerevisiae, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance Saccharomyces cerevisiae, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for Saccharomyces cerevisiae for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Saccharomyces cerevisiae was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for Saccharomyces cerevisiae for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Saccharomyces cerevisiae was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether Saccharomyces cerevisiae gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether Saccharomyces cerevisiae gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that Saccharomyces cerevisiae does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that Saccharomyces cerevisiae does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include Saccharomyces cerevisiae in Annex I to Regulation (EU) No 528/2012. As Saccharomyces cerevisiae is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Saccharomyces cerevisiae should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that Saccharomyces cerevisiae only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed. |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include Saccharomyces cerevisiae in Annex I to Regulation (EU) No 528/2012. As Saccharomyces cerevisiae is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Saccharomyces cerevisiae should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that Saccharomyces cerevisiae only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to Saccharomyces cerevisiae for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to Saccharomyces cerevisiae for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of Saccharomyces cerevisiae for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Saccharomyces cerevisiae (yeast) (*1) | Excluding Saccharomyces cerevisiae that is not food or feed. | CAS No 68876-77-7 |

EC number

Name/group

Restriction

Comment

‘Not available

Saccharomyces cerevisiae (yeast) (*1)

Excluding Saccharomyces cerevisiae that is not food or feed.

CAS No 68876-77-7

---

(*1)  The date of approval of Saccharomyces cerevisiae for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/7 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/7

---

COMMISSION DELEGATED REGULATION 2019/1821

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include powdered egg as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance powdered egg, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance powdered egg, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for powdered egg for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Powdered egg was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for powdered egg for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Powdered egg was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether powdered egg gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether powdered egg gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that powdered egg does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that powdered egg does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include powdered egg in Annex I to Regulation (EU) No 528/2012. As powdered egg is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Powdered egg should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that powdered egg only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed. |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include powdered egg in Annex I to Regulation (EU) No 528/2012. As powdered egg is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Powdered egg should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that powdered egg only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to powdered egg for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to powdered egg for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of powdered egg for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Powdered egg (*1) | Excluding powdered egg that is not food or feed. | |

EC number

Name/group

Restriction

Comment

‘Not available

Powdered egg (*1)

Excluding powdered egg that is not food or feed.

---

(*1)  The date of approval of powdered egg for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.

*1

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/10 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/10

---

COMMISSION DELEGATED REGULATION (EU) 2019/1822

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include honey as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance honey, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance honey, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for honey for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Honey was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for honey for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Honey was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether honey gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether honey gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that honey does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that honey does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include honey in Annex I to Regulation (EU) No 528/2012. As honey is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Honey should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that honey only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed. |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include honey in Annex I to Regulation (EU) No 528/2012. As honey is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Honey should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that honey only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to honey for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to honey for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of honey for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Honey (*1) | Excluding honey that is not food or feed. | CAS No 8028-66-8 |

EC number

Name/group

Restriction

Comment

‘Not available

Honey (*1)

Excluding honey that is not food or feed.

CAS No 8028-66-8

---

(*1)  The date of approval of honey for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’

*1

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/13 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/13

---

COMMISSION DELEGATED REGULATION (EU) 2019/1823

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include D-fructose as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance D-fructose, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance D-fructose, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for D-fructose for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. D-fructose was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for D-fructose for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. D-fructose was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether D‐fructose gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. The opinion of the Agency (5) concluded that D-fructose does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether D‐fructose gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. The opinion of the Agency (5) concluded that D-fructose does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (4) | Taking into account the opinion of the Agency, it is appropriate to include D-fructose in Annex I to Regulation (EU) No 528/2012. As D-fructose is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. D‐fructose should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that D-fructose only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed. |
| --- | --- |

(4)

Taking into account the opinion of the Agency, it is appropriate to include D-fructose in Annex I to Regulation (EU) No 528/2012. As D-fructose is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. D‐fructose should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that D-fructose only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.

| (5) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to D-fructose for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(5)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to D-fructose for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of D‐fructose for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘200-333-3 | D-Fructose (*1) | Excluding D-fructose that is not food or feed. | CAS No 57-48-7 |

EC number

Name/group

Restriction

Comment

‘200-333-3

D-Fructose (*1)

Excluding D-fructose that is not food or feed.

CAS No 57-48-7

---

(*1)  The date of approval of D-fructose for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.

*1

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/16 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/16

---

COMMISSION DELEGATED REGULATION (EU) 2019/1824

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include cheese as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance cheese, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance cheese, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for cheese for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Cheese was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for cheese for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Cheese was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether cheese gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether cheese gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that cheese does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that cheese does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include cheese in Annex I to Regulation (EU) No 528/2012. As cheese is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Cheese should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that cheese only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed. |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include cheese in Annex I to Regulation (EU) No 528/2012. As cheese is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Cheese should be included in that Annex only insofar as it falls within the definition of ‘food’ or ‘feed’ referred to in point (u) of Article 3(1) of that Regulation. This is consistent with the fact that cheese only benefited from the food and feed derogation provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to cheese for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to cheese for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of cheese for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Cheese (*1) | Excluding cheese that is not food or feed. | |

EC number

Name/group

Restriction

Comment

‘Not available

Cheese (*1)

Excluding cheese that is not food or feed.

---

(*1)  The date of approval of cheese for product-type 19 for the purposes of Article 89(3) is 1 June 2021.’.

*1

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/19 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/19

---

COMMISSION DELEGATED REGULATION (EU) 2019/1825

of 8 August 2019

amending Regulation (EU) No 528/2012 of the European Parliament and of the Council to include concentrated apple juice as an active substance in Annex I thereto

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 28(1) thereof,

Whereas:

| (1) | The active substance concentrated apple juice, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2). |
| --- | --- |

(1)

The active substance concentrated apple juice, insofar as it constituted food or feed intended for use as a repellent or attractant of product type 19, used to benefit from the food and feed derogation provided for in Article 6 of Commission Regulation (EC) No 1451/2007 (2).

| (2) | A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for concentrated apple juice for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Concentrated apple juice was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4). |
| --- | --- |

(2)

A notification was submitted pursuant to Article 16(5) of Commission Delegated Regulation (EU) No 1062/2014 (3) for concentrated apple juice for product type 19 benefiting from the food and feed derogation. The European Chemicals Agency (‘the Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Article 17 of that Regulation. Concentrated apple juice was consequently included for product type 19 in the list of substance/product type combinations included in the programme of review of existing active substances contained in biocidal products (4).

| (3) | On 31 January 2017 the Commission asked the Agency for an opinion on whether concentrated apple juice gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012. |
| --- | --- |

(3)

On 31 January 2017 the Commission asked the Agency for an opinion on whether concentrated apple juice gives rise to concern according to Article 28(2) of Regulation (EU) No 528/2012.

| (4) | The opinion of the Agency (5) concluded that concentrated apple juice does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. |
| --- | --- |

(4)

The opinion of the Agency (5) concluded that concentrated apple juice does not give rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012.

| (5) | Taking into account the opinion of the Agency, it is appropriate to include concentrated apple juice in Annex I to Regulation (EU) No 528/2012. As concentrated apple juice is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Concentrated apple juice should be included in that Annex only in so far it falls within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC (6). |
| --- | --- |

(5)

Taking into account the opinion of the Agency, it is appropriate to include concentrated apple juice in Annex I to Regulation (EU) No 528/2012. As concentrated apple juice is of natural origin, it should be included in category 4 ‘Traditionally used substances of natural origin’. Concentrated apple juice should be included in that Annex only in so far it falls within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC (6).

| (6) | Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to concentrated apple juice for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation, |
| --- | --- |

(6)

Article 89(3) of Regulation (EU) No 528/2012 contains transitional measures where an existing active substance included in the work programme for the systematic examination of existing active substances is approved in accordance with that Regulation. With respect to concentrated apple juice for product-type 19, the date of approval for the purposes of Article 89(3) of that Regulation should be set at 1 June 2021, in order to allow sufficient time for applications for authorisation to be submitted in accordance with the second subparagraph of Article 89(3) of that Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EU) No 528/2012 is amended in accordance with the Annex to this Regulation.

Article 2

For the purposes of Article 89(3) of Regulation (EU) No 528/2012, the date of approval of concentrated apple juice for product-type 19 is 1 June 2021.

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 August 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

2

(3)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

3

(4)  Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1).

4

(5)  Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.

5

(6)  Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).

6

---

ANNEX

In Annex I to Regulation (EU) No 528/2012, in Category 4 of the list of active substances referred to in Article 25(a), the following entry is added:

| EC number | Name/group | Restriction | Comment |
| --- | --- | --- | --- |
| ‘Not available | Concentrated apple juice (*1) | Excluding concentrated apple juice that does not fall within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC (*2). | |

EC number

Name/group

Restriction

Comment

‘Not available

Concentrated apple juice (*1)

Excluding concentrated apple juice that does not fall within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC (*2).

---

(*1)  The date of approval of concentrated apple juice for product-type 19 for the purposes of Article 89(3) is 1 June 2021.

*1

(*2)  Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58).’.

*2

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/22 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/22

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1826

of 25 October 2019

entering a name in the register of protected designations of origin and protected geographical indications (‘Kaimiškas Jovarų alus’ (PGI))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Lithuania’s application to register the name ‘Kaimiškas Jovarų alus’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Lithuania’s application to register the name ‘Kaimiškas Jovarų alus’ was published in the Official Journal of the European Union (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Kaimiškas Jovarų alus’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Kaimiškas Jovarų alus’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Kaimiškas Jovarų alus’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 2.1. – Beer, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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, 25 October 2019.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission

---

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

1

(2)  
  OJ C 217, 28.6.2019, p. 5.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/23 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/23

---

COMMISSION DELEGATED REGULATION (EU) 2019/1827

of 30 October 2019

amending Directive 2014/23/EU of the European Parliament and of the Council in respect of the threshold for concessions

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2014/23/EU of the European Parliament and of the Council of 26 February 2014 on the award of concession contracts (1), and in particular the second subparagraph of Article 9(4) thereof,

Whereas:

| (1) | By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights. |
| --- | --- |

(1)

By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights.

| (2) | One of the objectives of Directive 2014/23/EU is to allow the contracting entities and the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 9(1) of Directive 2014/23/EU, every two years the Commission is to verify that the threshold for concessions set out in Article 8(1) of that Directive corresponds to the threshold established in the Agreement. Given that the value of the threshold calculated in accordance with Article 9(1) of Directive 2014/23/EU is different from the value of the threshold set out in Article 8(1) of that Directive, it is necessary to revise this threshold. |
| --- | --- |

(2)

One of the objectives of Directive 2014/23/EU is to allow the contracting entities and the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 9(1) of Directive 2014/23/EU, every two years the Commission is to verify that the threshold for concessions set out in Article 8(1) of that Directive corresponds to the threshold established in the Agreement. Given that the value of the threshold calculated in accordance with Article 9(1) of Directive 2014/23/EU is different from the value of the threshold set out in Article 8(1) of that Directive, it is necessary to revise this threshold.

| (3) | Directive 2014/23/EU should therefore be amended accordingly, |
| --- | --- |

(3)

Directive 2014/23/EU should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 8(1) of Directive 2014/23/EU, ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’.

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.

It shall apply from 1 January 2020.

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

Done at Brussels, 30 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 94, 28.3.2014, p. 1.

1

(2)  Council Decision 2014/115/EU of 2 December 2013 on the conclusion of the Protocol Amending the Agreement on Government Procurement (OJ L 68, 7.3.2014, p. 1).

2

(3)  
  OJ L 68, 7.3.2014, p. 2.

3

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/25 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/25

---

COMMISSION DELEGATED REGULATION (EU) 2019/1828

of 30 October 2019

amending Directive 2014/24/EU of the European Parliament and of the Council in respect of the thresholds for public supply, service and works contracts, and design contests

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (1), and in particular the second subparagraph of Article 6(5) thereof,

Whereas:

| (1) | By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights. |
| --- | --- |

(1)

By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights.

| (2) | One of the objectives of Directive 2014/24/EU is to allow the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 6(1) of Directive 2014/24/EU, every two years the Commission is to verify that the thresholds for public contracts and design contests set out in points (a), (b) and (c) of Article 4 of that Directive correspond to the thresholds established in the Agreement. Given that the value of the thresholds calculated in accordance with Article 6(1) of Directive 2014/24/EU is different from the value of the thresholds set out in points (a), (b) and (c) of Article 4 of that Directive, it is necessary to revise these thresholds. In accordance with Article 6(2) of Directive 2014/24/EU, the thresholds established in Article 13 of that Directive are to be aligned with the thresholds set out in points (a) and (c) of Article 4 of that Directive. |
| --- | --- |

(2)

One of the objectives of Directive 2014/24/EU is to allow the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 6(1) of Directive 2014/24/EU, every two years the Commission is to verify that the thresholds for public contracts and design contests set out in points (a), (b) and (c) of Article 4 of that Directive correspond to the thresholds established in the Agreement. Given that the value of the thresholds calculated in accordance with Article 6(1) of Directive 2014/24/EU is different from the value of the thresholds set out in points (a), (b) and (c) of Article 4 of that Directive, it is necessary to revise these thresholds. In accordance with Article 6(2) of Directive 2014/24/EU, the thresholds established in Article 13 of that Directive are to be aligned with the thresholds set out in points (a) and (c) of Article 4 of that Directive.

| (3) | Directive 2014/24/EU should therefore be amended accordingly, |
| --- | --- |

(3)

Directive 2014/24/EU should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Directive 2014/24/EU is amended as follows:

| (1) | Article 4 is amended as follows:






  (a) | in point (a), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’; |
| --- | --- | --- |

(1)

Article 4 is amended as follows:

(a)

in point (a), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’;

| (b) | in point (b), ‘EUR 144 000’ is replaced by ‘EUR 139 000’; |
| --- | --- |

(b)

in point (b), ‘EUR 144 000’ is replaced by ‘EUR 139 000’;

| (c) | in point (c), ‘EUR 221 000’ is replaced by ‘EUR 214 000’; |
| --- | --- |

(c)

in point (c), ‘EUR 221 000’ is replaced by ‘EUR 214 000’;

| (2) | the first paragraph of Article 13 is amended as follows:






  (a) | in point (a), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’; |
| --- | --- | --- |

(2)

the first paragraph of Article 13 is amended as follows:

(a)

in point (a), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’;

| (b) | in point (b), ‘EUR 221 000’ is replaced by ‘EUR 214 000’. |
| --- | --- |

(b)

in point (b), ‘EUR 221 000’ is replaced by ‘EUR 214 000’.

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.

It shall apply from 1 January 2020.

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

Done at Brussels, 30 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 94, 28.3.2014, p. 65.

1

(2)  Council Decision 2014/115/EU of 2 December 2013 on the conclusion of the Protocol Amending the Agreement on Government Procurement (OJ L 68, 7.3.2014, p. 1).

2

(3)  
  OJ L 68, 7.3.2014, p. 2.

3

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/27 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/27

---

COMMISSION DELEGATED REGULATION (EU) 2019/1829

of 30 October 2019

amending Directive 2014/25/EU of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts, and design contests

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (1), and in particular the second subparagraph of Article 17(4) thereof,

Whereas:

| (1) | By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights. |
| --- | --- |

(1)

By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights.

| (2) | One of the objectives of Directive 2014/25/EU is to allow the contracting entities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 17(1) of Directive 2014/25/EU, every two years the Commission is to verify that the thresholds for contracts and design contests set out in points (a) and (b) of Article 15 of that Directive correspond to the thresholds established in the Agreement. Given that the value of the thresholds calculated in accordance with Article 17(1) of Directive 2014/25/EU is different from the value of the thresholds set out in points (a) and (b) of Article 15 of that Directive, it is necessary to revise these thresholds. |
| --- | --- |

(2)

One of the objectives of Directive 2014/25/EU is to allow the contracting entities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 17(1) of Directive 2014/25/EU, every two years the Commission is to verify that the thresholds for contracts and design contests set out in points (a) and (b) of Article 15 of that Directive correspond to the thresholds established in the Agreement. Given that the value of the thresholds calculated in accordance with Article 17(1) of Directive 2014/25/EU is different from the value of the thresholds set out in points (a) and (b) of Article 15 of that Directive, it is necessary to revise these thresholds.

| (3) | Directive 2014/25/EU should therefore be amended accordingly, |
| --- | --- |

(3)

Directive 2014/25/EU should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 15 of Directive 2014/25/EU is amended as follows:

| (1) | in point (a), ‘EUR 443 000’ is replaced by ‘EUR 428 000’; |
| --- | --- |

(1)

in point (a), ‘EUR 443 000’ is replaced by ‘EUR 428 000’;

| (2) | in point (b), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’. |
| --- | --- |

(2)

in point (b), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’.

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.

It shall apply from 1 January 2020.

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

Done at Brussels, 30 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 94, 28.3.2014, p. 243.

1

(2)  Council Decision 2014/115/EU of 2 December 2013 on the conclusion of the Protocol Amending the Agreement on Government Procurement (OJ L 68, 7.3.2014, p. 1).

2

(3)  
  OJ L 68, 7.3.2014, p. 2.

3

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/29 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/29

---

COMMISSION DELEGATED REGULATION (EU) 2019/1830

of 30 October 2019

amending Directive 2009/81/EC of the European Parliament and of the Council in respect of the thresholds for supply, service and works contracts

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC (1), and in particular the second subparagraph of Article 68(1) thereof,

Whereas:

| (1) | By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights. |
| --- | --- |

(1)

By Decision 2014/115/EU (2), the Council approved the Protocol amending the Agreement on Government Procurement (3) (‘the Agreement’) concluded in the framework of the World Trade Organization. The Agreement is a plurilateral instrument and its purpose is to mutually open government procurement markets among its parties. It applies to any procurement contract with a value that reaches or exceeds the amounts (‘thresholds’) set in it and expressed as special drawing rights.

| (2) | One of the objectives of Directive 2014/25/EU of the European Parliament and of the Council (4) is to allow the contracting entities and the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 17 of Directive 2014/25/EU every two years the Commission is to verify that the thresholds set out in points (a) and (b) of Article 15 of that Directive correspond to the thresholds established in the Agreement and is to, where necessary, revise them. |
| --- | --- |

(2)

One of the objectives of Directive 2014/25/EU of the European Parliament and of the Council (4) is to allow the contracting entities and the contracting authorities, which apply that Directive, to comply at the same time with the obligations laid down in the Agreement. In accordance with Article 17 of Directive 2014/25/EU every two years the Commission is to verify that the thresholds set out in points (a) and (b) of Article 15 of that Directive correspond to the thresholds established in the Agreement and is to, where necessary, revise them.

| (3) | The thresholds laid down in Directive 2014/25/EU have been revised. In accordance with Article 68(1) of Directive 2009/81/EC, the thresholds laid down in that Directive are to be aligned to the revised thresholds laid down in Directive 2014/25/EU. |
| --- | --- |

(3)

The thresholds laid down in Directive 2014/25/EU have been revised. In accordance with Article 68(1) of Directive 2009/81/EC, the thresholds laid down in that Directive are to be aligned to the revised thresholds laid down in Directive 2014/25/EU.

| (4) | Directive 2009/81/EC should therefore be amended accordingly, |
| --- | --- |

(4)

Directive 2009/81/EC should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Article 8 of Directive 2009/81/EC is amended as follows:

| (1) | in point (a), ‘EUR 443 000’ is replaced by ‘EUR 428 000’; |
| --- | --- |

(1)

in point (a), ‘EUR 443 000’ is replaced by ‘EUR 428 000’;

| (2) | in point (b), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’. |
| --- | --- |

(2)

in point (b), ‘EUR 5 548 000’ is replaced by ‘EUR 5 350 000’.

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.

It shall apply from 1 January 2020.

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

Done at Brussels, 30 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 216, 20.8.2009, p. 76.

1

(2)  Council Decision 2014/115/EU of 2 December 2013 on the conclusion of the Protocol Amending the Agreement on Government Procurement (OJ L 68, 7.3.2014, p. 1).

2

(3)  
  OJ L 68, 7.3.2014, p. 2.

3

(4)  Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243).

4

---

DIRECTIVES

| 31.10.2019 | EN | Official Journal of the European Union | L 279/31 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/31

---

COMMISSION DIRECTIVE (EU) 2019/1831

of 24 October 2019

establishing a fifth list of indicative occupational exposure limit values pursuant to Council Directive 98/24/EC and amending Commission Directive 2000/39/EC

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (1), and in particular Article 3(2) thereof,

Whereas:

| (1) | Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, states that every worker has the right to a healthy, safe and well-adapted work environment. The right to a high level of protection for health and safety at work, and to a working environment that is adapted to workers’ professional needs and enables them to participate in the labour market for an extended period also includes protection from exposure to chemical agents at work. |
| --- | --- |

(1)

Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, states that every worker has the right to a healthy, safe and well-adapted work environment. The right to a high level of protection for health and safety at work, and to a working environment that is adapted to workers’ professional needs and enables them to participate in the labour market for an extended period also includes protection from exposure to chemical agents at work.

| (2) | The Commission clearly emphasised the need to continue improving workers’ protection from exposure to dangerous chemicals at work in its communication ‘Safer and Healthier Work for All’. (3) |
| --- | --- |

(2)

The Commission clearly emphasised the need to continue improving workers’ protection from exposure to dangerous chemicals at work in its communication ‘Safer and Healthier Work for All’. (3)

| (3) | Pursuant to Directive 98/24/EC, the Commission is to propose European Union (EU) objectives in the form of indicative occupational exposure limit values (IOELVs) to be set at EU level, to protect workers from risks arising from exposure to hazardous chemicals. |
| --- | --- |

(3)

Pursuant to Directive 98/24/EC, the Commission is to propose European Union (EU) objectives in the form of indicative occupational exposure limit values (IOELVs) to be set at EU level, to protect workers from risks arising from exposure to hazardous chemicals.

| (4) | Article 3(2) of Directive 98/24/EC empowers the Commission to establish or revise IOELVs, taking into account the availability of measurement techniques based on measures adopted in accordance with the procedure laid down in Article 17 of Council Directive 89/391/EEC (4). |
| --- | --- |

(4)

Article 3(2) of Directive 98/24/EC empowers the Commission to establish or revise IOELVs, taking into account the availability of measurement techniques based on measures adopted in accordance with the procedure laid down in Article 17 of Council Directive 89/391/EEC (4).

| (5) | Article 3(1) of Directive 98/24/EC states that the Commission shall evaluate, through an independent scientific assessment of the latest available scientific data, the relationship between the health effects of hazardous chemical agents and the level of occupational exposure. |
| --- | --- |

(5)

Article 3(1) of Directive 98/24/EC states that the Commission shall evaluate, through an independent scientific assessment of the latest available scientific data, the relationship between the health effects of hazardous chemical agents and the level of occupational exposure.

| (6) | The Commission is assisted in this task by the Scientific Committee on Occupational Exposure Limits for Chemical Agents (SCOEL), set up by Commission Decision 2014/113/EU. (5) |
| --- | --- |

(6)

The Commission is assisted in this task by the Scientific Committee on Occupational Exposure Limits for Chemical Agents (SCOEL), set up by Commission Decision 2014/113/EU. (5)

| (7) | Under Directive 98/24/EC, ‘occupational exposure limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration of a chemical agent in the air within a worker’s breathing zone, in relation to a specified reference period. |
| --- | --- |

(7)

Under Directive 98/24/EC, ‘occupational exposure limit value’ means, unless otherwise specified, the limit of the time-weighted average of the concentration of a chemical agent in the air within a worker’s breathing zone, in relation to a specified reference period.

| (8) | IOELVs are health-based occupational exposure limit values, derived from the most recent scientific data available and adopted by the Commission, taking into account the availability of measurement techniques. They are threshold levels of exposure below which, in general, no detrimental effects are expected for any given chemical agent after short-term or daily exposure over a working lifetime. They constitute EU objectives and are designed to help employers determine and assess risks and implement preventive and protective measures, in accordance with Directive 98/24/EC. |
| --- | --- |

(8)

IOELVs are health-based occupational exposure limit values, derived from the most recent scientific data available and adopted by the Commission, taking into account the availability of measurement techniques. They are threshold levels of exposure below which, in general, no detrimental effects are expected for any given chemical agent after short-term or daily exposure over a working lifetime. They constitute EU objectives and are designed to help employers determine and assess risks and implement preventive and protective measures, in accordance with Directive 98/24/EC.

| (9) | In accordance with SCOEL recommendations, IOELVs are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and, for certain chemical agents, to shorter reference periods, in general 15 minutes time-weighted average (short-term exposure limit values), to take account of the effects arising from short-term exposure. |
| --- | --- |

(9)

In accordance with SCOEL recommendations, IOELVs are established in relation to a reference period of eight hours time-weighted average (long-term exposure limit values) and, for certain chemical agents, to shorter reference periods, in general 15 minutes time-weighted average (short-term exposure limit values), to take account of the effects arising from short-term exposure.

| (10) | For any chemical agent for which an IOELV has been set at EU level, Member States are required to establish a national occupational exposure limit value. In doing so, they are required to take into account the EU limit value, determining the nature of the national limit value in accordance with national legislation and practice. |
| --- | --- |

(10)

For any chemical agent for which an IOELV has been set at EU level, Member States are required to establish a national occupational exposure limit value. In doing so, they are required to take into account the EU limit value, determining the nature of the national limit value in accordance with national legislation and practice.

| (11) | IOELVs are an important part of the general arrangements for protecting workers against the health risks arising from exposure to hazardous chemicals. |
| --- | --- |

(11)

IOELVs are an important part of the general arrangements for protecting workers against the health risks arising from exposure to hazardous chemicals.

| (12) | In accordance with Article 3 of Directive 98/24/EC, SCOEL has assessed the relationship between the health effects of the chemical agents listed in the 10 entries in the Annex to this Directive and the level of occupational exposure. Similarly, for all these chemical agents it has recommended establishing IOELVs for the inhalation route of exposure in relation to a reference period of eight hours time-weighted average. It is therefore appropriate to lay down long-term exposure limit values for all these agents in the Annex to this Directive. |
| --- | --- |

(12)

In accordance with Article 3 of Directive 98/24/EC, SCOEL has assessed the relationship between the health effects of the chemical agents listed in the 10 entries in the Annex to this Directive and the level of occupational exposure. Similarly, for all these chemical agents it has recommended establishing IOELVs for the inhalation route of exposure in relation to a reference period of eight hours time-weighted average. It is therefore appropriate to lay down long-term exposure limit values for all these agents in the Annex to this Directive.

| (13) | For some of these chemical agents, i.e. aniline, trimethylamine, 2-phenylpropane (cumene), sec-butyl acetate, 4-aminotoluene, isobutyl acetate, isoamyl alcohol, n-butyl acetate and phosphoryl trichloride, SCOEL also recommended establishing short-term exposure limit values. |
| --- | --- |

(13)

For some of these chemical agents, i.e. aniline, trimethylamine, 2-phenylpropane (cumene), sec-butyl acetate, 4-aminotoluene, isobutyl acetate, isoamyl alcohol, n-butyl acetate and phosphoryl trichloride, SCOEL also recommended establishing short-term exposure limit values.

| (14) | For certain substances, it is necessary to take into account the possibility of penetration through the skin in order to ensure the best possible level of protection. Among the chemical agents listed in the entries in the Annex to this Directive, SCOEL identified the possibility of significant uptake through the skin for aniline, 2-phenylpropane (cumene) and 4-aminotoluene. It is therefore appropriate to include in the Annex to this Directive notations indicating the possibility of significant uptake through the skin for these chemical agents, in addition to the IOELVs. |
| --- | --- |

(14)

For certain substances, it is necessary to take into account the possibility of penetration through the skin in order to ensure the best possible level of protection. Among the chemical agents listed in the entries in the Annex to this Directive, SCOEL identified the possibility of significant uptake through the skin for aniline, 2-phenylpropane (cumene) and 4-aminotoluene. It is therefore appropriate to include in the Annex to this Directive notations indicating the possibility of significant uptake through the skin for these chemical agents, in addition to the IOELVs.

| (15) | One of the chemical agents, 2-phenylpropane (cumene), is currently listed in the Annex to Commission Directive 2000/39/EC (6). SCOEL has recommended establishing a new IOELV for this substance. It is therefore appropriate to include a revised limit value for 2-phenylpropane (cumene) in the Annex to this Directive and to delete the corresponding entry from the Annex to Directive 2000/39/EC. |
| --- | --- |

(15)

One of the chemical agents, 2-phenylpropane (cumene), is currently listed in the Annex to Commission Directive 2000/39/EC (6). SCOEL has recommended establishing a new IOELV for this substance. It is therefore appropriate to include a revised limit value for 2-phenylpropane (cumene) in the Annex to this Directive and to delete the corresponding entry from the Annex to Directive 2000/39/EC.

| (16) | In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. |
| --- | --- |

(16)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (7), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

| (17) | As regards this Directive, the Commission considers it justified to send such documents in the form of a table showing the correlation between the national measures and this Directive, given that for some agents national occupational exposure limit values already exist in national legislation, and given the variety and the technical nature of national legal instruments for establishing occupational exposure limit values. |
| --- | --- |

(17)

As regards this Directive, the Commission considers it justified to send such documents in the form of a table showing the correlation between the national measures and this Directive, given that for some agents national occupational exposure limit values already exist in national legislation, and given the variety and the technical nature of national legal instruments for establishing occupational exposure limit values.

| (18) | The Advisory Committee on Safety and Health at Work was consulted in accordance with Article 3(2) of Directive 98/24/EC and gave its opinions on 6 December 2017 and 31 May 2018. The Committee acknowledged that there were currently challenges as regards the availability of measurement methodologies that could be used to demonstrate compliance with the proposed limit values for phosphoryl trichloride and isoamyl alcohol, and that efforts should be made to ensure that suitable techniques were available by the end of the transposition period. |
| --- | --- |

(18)

The Advisory Committee on Safety and Health at Work was consulted in accordance with Article 3(2) of Directive 98/24/EC and gave its opinions on 6 December 2017 and 31 May 2018. The Committee acknowledged that there were currently challenges as regards the availability of measurement methodologies that could be used to demonstrate compliance with the proposed limit values for phosphoryl trichloride and isoamyl alcohol, and that efforts should be made to ensure that suitable techniques were available by the end of the transposition period.

| (19) | The measures for which this Directive provides are in accordance with the opinion of the Technical Progress Committee established under Article 17 of Directive 89/391/EEC. |
| --- | --- |

(19)

The measures for which this Directive provides are in accordance with the opinion of the Technical Progress Committee established under Article 17 of Directive 89/391/EEC.

HAS ADOPTED THIS DIRECTIVE:

Article 1

A fifth list of EU indicative occupational exposure limit values is established for the chemical agents listed in the Annex.

Article 2

Member States shall establish national occupational exposure limit values for the chemical agents listed in the Annex, taking into account the EU limit values.

Article 3

In the Annex to Directive 2000/39/EC, the reference to cumene is deleted with effect from 20 May 2021.

Article 4

1.   The Member States shall adopt and publish, by 20 May 2021 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.

They shall forthwith communicate to the Commission the text of those provisions and shall accompany their notification with one or more explanatory documents in the form of tables showing the correlation between the provisions and this Directive.

When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main national legal provisions which they adopt in the field covered by this Directive.

Article 5

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

Article 6

This Directive is addressed to the Member States.

Done at Brussels, 24 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 131, 5.5.1998, p. 11.

1

(2)  European Pillar of Social Rights, November 2017, https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en

2

(3)  Communication from the Commission ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ COM/2017/012 final. http://ec.europa.eu/social/main.jsp?langId=en&catId=89&newsId=2709

3

(4)  Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

4

(5)  Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).

5

(6)  Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work (OJ L 142, 16.6.2000, p. 47).

6

(7)  
  OJ C 369, 17.12.2011, p. 14.

7

---

ANNEX

| EC No (1) | CAS No (2) | Name of the chemical agent | Limit values | Notation (3) |
| --- | --- | --- | --- | --- |
| 8 hours (4) | Short-term (5) |
| mg/m3
   (6) | ppm  (7) | mg/m3
   (6) | ppm (7) |
| 200-539-3 | 62-53-3 | Aniline (8) | 7,74 | 2 | 19,35 | 5 | skin |
| 200-817-4 | 74-87-3 | Chloromethane | 42 | 20 | - | - | - |
| 200-875-0 | 75-50-3 | Trimethylamine | 4,9 | 2 | 12,5 | 5 | - |
| 202-704-5 | 98-82-8 | 2-Phenylpropane
  (Cumene) (8) | 50 | 10 | 250 | 50 | skin |
| 203-300-1 | 105-46-4 | sec-Butyl acetate | 241 | 50 | 723 | 150 | - |
| 203-403-1 | 106-49-0 | 4-aminotoluene | 4,46 | 1 | 8,92 | 2 | skin |
| 203-745-1 | 110-19-0 | Isobutyl acetate | 241 | 50 | 723 | 150 | - |
| 204-633-5 | 123-51-3 | Isoamyl alcohol | 18 | 5 | 37 | 10 | - |
| 204-658-1 | 123-86-4 | n-Butyl acetate | 241 | 50 | 723 | 150 | - |
| 233-046-7 | 10025-87-3 | Phosphoryl trichloride | 0,064 | 0,01 | 0,12 | 0,02 | - |

EC No (1)

CAS No (2)

Name of the chemical agent

Limit values

Notation (3)

8 hours (4)

Short-term (5)

mg/m3
   (6)

ppm  (7)

mg/m3
   (6)

ppm (7)

200-539-3

62-53-3

Aniline (8)

7,74

2

19,35

5

skin

200-817-4

74-87-3

Chloromethane

42

20

-

-

-

200-875-0

75-50-3

Trimethylamine

4,9

2

12,5

5

-

202-704-5

98-82-8

2-Phenylpropane

(Cumene) (8)

50

10

250

50

skin

203-300-1

105-46-4

sec-Butyl acetate

241

50

723

150

-

203-403-1

106-49-0

4-aminotoluene

4,46

1

8,92

2

skin

203-745-1

110-19-0

Isobutyl acetate

241

50

723

150

-

204-633-5

123-51-3

Isoamyl alcohol

18

5

37

10

-

204-658-1

123-86-4

n-Butyl acetate

241

50

723

150

-

233-046-7

10025-87-3

Phosphoryl trichloride

0,064

0,01

0,12

0,02

-

---

(1)  EC No: European Community (EC) number, the European Union’s numerical identifier for substances.

(2)  CAS No: Chemical Abstract Service Registry Number.

(3)  A skin notation assigned to the occupational exposure limit value indicates the possibility of significant uptake through the skin.

(4)  Measured or calculated in relation to a reference period of eight hours time-weighted average (TWA).

(5)  Short-term exposure limit (STEL). A limit value which must not be exceeded. The period to which it relates is 15 minutes, unless otherwise specified.

(6)  mg/m3: milligrams per cubic metre of air. For chemicals in gas or vapour phase, the limit value is expressed at 20 °C and 101,3 kPa.

(7)  ppm: parts per million by volume in air (ml/m3).

(8)  During exposure monitoring, account should be taken of relevant biological monitoring values as suggested by the Scientific Committee on Occupational Exposure Limits for Chemicals Agents (SCOEL).

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/35 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/35

---

COMMISSION DIRECTIVE 2019/1832

of 24 October 2019

amending Annexes I, II and III to Council Directive 89/656/EEC as regards purely technical adjustments

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (1), and in particular Article 9 thereof,

Whereas:

| (1) | Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes the use of personal protective equipment at the workplace if risks cannot be avoided or sufficiently limited by other means, measures, methods or procedures of work organisation. |
| --- | --- |

(1)

Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes the use of personal protective equipment at the workplace if risks cannot be avoided or sufficiently limited by other means, measures, methods or procedures of work organisation.

| (2) | The implementation of the directives related to the health and safety of workers at work, including Directive 89/656/EEC, was the subject of an ex-post evaluation, referred to as a REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the use of personal protective equipment concerns approximately 40 % of the EU’s workforce, as risks at the workplace cannot be avoided by any other means, and that there is a need to address difficulties in implementing Directive 89/656/EEC. |
| --- | --- |

(2)

The implementation of the directives related to the health and safety of workers at work, including Directive 89/656/EEC, was the subject of an ex-post evaluation, referred to as a REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the use of personal protective equipment concerns approximately 40 % of the EU’s workforce, as risks at the workplace cannot be avoided by any other means, and that there is a need to address difficulties in implementing Directive 89/656/EEC.

| (3) | In its Communication ‘Safer and Healthier Work for All – Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational health and safety confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to consider the definition of personal protective equipment and its use by different services and sectors, as set out in Article 2 of Directive 89/656/EEC. |
| --- | --- |

(3)

In its Communication ‘Safer and Healthier Work for All – Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational health and safety confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to consider the definition of personal protective equipment and its use by different services and sectors, as set out in Article 2 of Directive 89/656/EEC.

| (4) | Directive 89/656/EEC lays down minimum requirements for the use of personal protective equipment used by workers at work, which is to be used when the risks concerned cannot be avoided or sufficiently limited by technical means of collective protection or by measures, methods or procedures of work organisation. To facilitate the establishment of the general rules required pursuant to Article 6 of Directive 89/656/EEC, Annexes I, II and III to Directive 89/656/EEC provide non-binding guidelines intended to facilitate and support the selection of appropriate personal protective equipment for the risks, activities and sectors concerned. |
| --- | --- |

(4)

Directive 89/656/EEC lays down minimum requirements for the use of personal protective equipment used by workers at work, which is to be used when the risks concerned cannot be avoided or sufficiently limited by technical means of collective protection or by measures, methods or procedures of work organisation. To facilitate the establishment of the general rules required pursuant to Article 6 of Directive 89/656/EEC, Annexes I, II and III to Directive 89/656/EEC provide non-binding guidelines intended to facilitate and support the selection of appropriate personal protective equipment for the risks, activities and sectors concerned.

| (5) | Regulation (EU) 2016/425 of the European Parliament and of the Council (5) lays down the provisions regarding the design, manufacture and marketing of personal protective equipment. Regulation (EU) 2016/425 modified the risk categorisation of products, to enable employers to understand and thus to deploy personal protective equipment, as further explained in the Personal Protective Equipment Guidelines (6) that clarify procedures and matters referred to in Regulation (EU) 2016/425. It is considered appropriate to update Annexes I, II and III to Directive 89/656/EEC in order to ensure consistency with the risk classification laid down in Regulation (EU) 2016/425 and to align them with terminologies used and types of personal protective equipment referred to in Regulation (EU) 2016/425. |
| --- | --- |

(5)

Regulation (EU) 2016/425 of the European Parliament and of the Council (5) lays down the provisions regarding the design, manufacture and marketing of personal protective equipment. Regulation (EU) 2016/425 modified the risk categorisation of products, to enable employers to understand and thus to deploy personal protective equipment, as further explained in the Personal Protective Equipment Guidelines (6) that clarify procedures and matters referred to in Regulation (EU) 2016/425. It is considered appropriate to update Annexes I, II and III to Directive 89/656/EEC in order to ensure consistency with the risk classification laid down in Regulation (EU) 2016/425 and to align them with terminologies used and types of personal protective equipment referred to in Regulation (EU) 2016/425.

| (6) | Article 4(1) of Directive 89/656/EEC foresees that employers must provide personal protective equipment that complies with the relevant Union provisions on design and manufacture with respect to safety and health. Pursuant to that Article, employers who provide that personal protective equipment to their workers must ensure that such personal protective equipment fulfils the requirements laid down in Regulation (EU) 2016/425. |
| --- | --- |

(6)

Article 4(1) of Directive 89/656/EEC foresees that employers must provide personal protective equipment that complies with the relevant Union provisions on design and manufacture with respect to safety and health. Pursuant to that Article, employers who provide that personal protective equipment to their workers must ensure that such personal protective equipment fulfils the requirements laid down in Regulation (EU) 2016/425.

| (7) | Annex I to Directive 89/656/EEC sets out a specimen risk survey table for the use of personal protective equipment and sets out types of risks that could occur in workplaces in relation to different parts of the body to be protected by personal protective equipment. Annex I should be amended to take account of new types of risks that appear in workplaces and to ensure consistency with the risk classification and the terminology used, in particular in Regulation (EU) 2016/425. |
| --- | --- |

(7)

Annex I to Directive 89/656/EEC sets out a specimen risk survey table for the use of personal protective equipment and sets out types of risks that could occur in workplaces in relation to different parts of the body to be protected by personal protective equipment. Annex I should be amended to take account of new types of risks that appear in workplaces and to ensure consistency with the risk classification and the terminology used, in particular in Regulation (EU) 2016/425.

| (8) | Annex II to Directive 89/656/EEC, which sets out a non-exhaustive guide list of types of personal protective equipment, should be amended to take account of the new types of risks identified in Annex I to that directive. Annex II should also be amended to include examples of personal protective equipment currently available on the market in conformity with Regulation (EU) 2016/425 and the terminology used in that Regulation. |
| --- | --- |

(8)

Annex II to Directive 89/656/EEC, which sets out a non-exhaustive guide list of types of personal protective equipment, should be amended to take account of the new types of risks identified in Annex I to that directive. Annex II should also be amended to include examples of personal protective equipment currently available on the market in conformity with Regulation (EU) 2016/425 and the terminology used in that Regulation.

| (9) | Annex III to Directive 89/656/EEC sets out a non-exhaustive guide list of activities and sectors of activity that could require the provision of personal protective equipment, bringing together the risk classifications set out in Annex I to that directive and the types of personal protective equipment described in Annex II to that directive. Annex III to Directive 89/656/EEC should be restructured to ensure consistency between the terminology and classifications used across the three annexes and with Regulation (EU) 2016/425. This will enable employers from different sectors and industries to better identify and provide personal protective equipment that corresponds to specific activities and the specific types of risks that workers are exposed to, as indicated by the risk assessment. |
| --- | --- |

(9)

Annex III to Directive 89/656/EEC sets out a non-exhaustive guide list of activities and sectors of activity that could require the provision of personal protective equipment, bringing together the risk classifications set out in Annex I to that directive and the types of personal protective equipment described in Annex II to that directive. Annex III to Directive 89/656/EEC should be restructured to ensure consistency between the terminology and classifications used across the three annexes and with Regulation (EU) 2016/425. This will enable employers from different sectors and industries to better identify and provide personal protective equipment that corresponds to specific activities and the specific types of risks that workers are exposed to, as indicated by the risk assessment.

| (10) | The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All – Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational health and safety legislation effective and fit-for-purpose. |
| --- | --- |

(10)

The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All – Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational health and safety legislation effective and fit-for-purpose.

| (11) | In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (7), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Directive 89/656/EEC should be amended to enhance its relevance and effectiveness. |
| --- | --- |

(11)

In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (7), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Directive 89/656/EEC should be amended to enhance its relevance and effectiveness.

| (12) | In a subsequent ‘Opinion on technical updates to the annexes of the Personal Protective Equipment Directive (89/656/EEC)’ (8), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that specific updates to Annex I, II and III to Directive 89/656/EEC, taking into account the latest technological developments in the field and ensuring consistency with Regulation (EU) 2016/425, should be carried out. |
| --- | --- |

(12)

In a subsequent ‘Opinion on technical updates to the annexes of the Personal Protective Equipment Directive (89/656/EEC)’ (8), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that specific updates to Annex I, II and III to Directive 89/656/EEC, taking into account the latest technological developments in the field and ensuring consistency with Regulation (EU) 2016/425, should be carried out.

| (13) | In preparing the current update of Annexes I, II and III to Directive 89/656/EEC, the Commission was assisted by experts representing Member States, who provided technical and scientific support. |
| --- | --- |

(13)

In preparing the current update of Annexes I, II and III to Directive 89/656/EEC, the Commission was assisted by experts representing Member States, who provided technical and scientific support.

| (14) | In accordance with the Joint Political Declaration on explanatory documents (9), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. |
| --- | --- |

(14)

In accordance with the Joint Political Declaration on explanatory documents (9), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

| (15) | The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 17 of Council Directive 89/391/EEC (10), |
| --- | --- |

(15)

The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 17 of Council Directive 89/391/EEC (10),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes I, II and III to Directive 89/656/EEC are replaced by the text in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 24 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 393, 30.12.1989, p. 18.

1

(2)  European Pillar of Social Rights, 2017, https://ec.europa.eu/commission/sites/beta-political/files/social-summit-european-pillar-social-rights-booklet_en.pdf

2

(3)  SWD(2017) 10 final

3

(4)  COM(2017) 12

4

(5)  Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (OJ L 81, 31.3.2016, p. 51).

5

(6)  PPE Regulation Guidelines – Guide to application of Regulation (EU) 2016/425 on personal protective equipment, https://ec.europa.eu/docsroom/documents/29201

6

(7)  Advisory Committee for Safety and Health at Work Doc. 1718/2017

7

(8)  Advisory Committee for Safety and Health at Work Doc. 443/18

8

(9)  
  OJ C 369, 17.12.2011, p. 14.

9

(10)  Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

10

---

ANNEX

(1)

Annex I to Directive 89/656/EEC is replaced by the following:

‘ANNEX I

RISKS IN RELATION TO THE BODY PARTS TO BE PROTECTED BY PPE (*)

(*) This list of risks/parts of the body cannot be expected to be exhaustive.

The risk assessment will determine the need to provide a PPE and its characteristics according to the provisions of this Directive.

Image 1

(2)

Annex II to Directive 89/656/EEC is replaced by the following:

‘ANNEX II

NON-EXHAUSTIVE LIST OF TYPES OF PERSONAL PROTECTIVE EQUIPMENT WITH REGARD TO THE RISKS THEY PROVIDE PROTECTION AGAINST

Equipment for HEAD PROTECTION

| — | Helmets and/or caps/balaclavas/headgears against:






  — | Impacts caused by falling or ejected object |
| --- | --- | --- |

—

Helmets and/or caps/balaclavas/headgears against:

—

Impacts caused by falling or ejected object

| — | Collision with an obstacle |
| --- | --- |

—

Collision with an obstacle

| — | Mechanical risks (perforation, abrasion) |
| --- | --- |

—

Mechanical risks (perforation, abrasion)

| — | Static compression (lateral crushing) |
| --- | --- |

—

Static compression (lateral crushing)

| — | Thermal risks (fire, heat, cold, hot solids including molten metals) |
| --- | --- |

—

Thermal risks (fire, heat, cold, hot solids including molten metals)

| — | Electric shock and live working |
| --- | --- |

—

Electric shock and live working

| — | Chemical risks |
| --- | --- |

—

Chemical risks

| — | Non-ionizing radiation (UV, IR, solar or welding radiation) |
| --- | --- |

—

Non-ionizing radiation (UV, IR, solar or welding radiation)

| — | Hairnets against risk of entanglement |
| --- | --- |

—

Hairnets against risk of entanglement

Equipment for HEARING PROTECTION

| — | Earmuffs (including e.g. earmuffs attached to a helmet, active noise reduction earmuffs, earmuffs with electrical audio input) |
| --- | --- |

—

Earmuffs (including e.g. earmuffs attached to a helmet, active noise reduction earmuffs, earmuffs with electrical audio input)

| — | Earplugs (including e.g. level-dependent earplugs, earplugs adapted to the individual) |
| --- | --- |

—

Earplugs (including e.g. level-dependent earplugs, earplugs adapted to the individual)

Equipment for EYE AND FACE PROTECTION

| — | Spectacles, goggles and face shields (prescription lenses where appropriate) against:






  — | Mechanical risks |
| --- | --- | --- |

—

Spectacles, goggles and face shields (prescription lenses where appropriate) against:

—

Mechanical risks

| — | Thermal risks |
| --- | --- |

—

Thermal risks

| — | Non-ionizing radiation (UV, IR, solar or welding radiation) |
| --- | --- |

—

Non-ionizing radiation (UV, IR, solar or welding radiation)

| — | Ionizing radiation |
| --- | --- |

—

Ionizing radiation

| — | Solid aerosols and liquids of chemical and biological agents |
| --- | --- |

—

Solid aerosols and liquids of chemical and biological agents

Equipment for RESPIRATORY PROTECTION

| — | Filtering devices against:






  — | Particles |
| --- | --- | --- |

—

Filtering devices against:

—

Particles

| — | Gases |
| --- | --- |

—

Gases

| — | Particles and gases |
| --- | --- |

—

Particles and gases

| — | Solid and/or liquid aerosols |
| --- | --- |

—

Solid and/or liquid aerosols

| — | Insulating devices, including with an air supply |
| --- | --- |

—

Insulating devices, including with an air supply

| — | Self-rescue devices |
| --- | --- |

—

Self-rescue devices

| — | Diving equipment |
| --- | --- |

—

Diving equipment

Equipment for HAND AND ARM PROTECTION

| — | Gloves (including mittens and arm protection) against:






  — | Mechanical risks |
| --- | --- | --- |

—

Gloves (including mittens and arm protection) against:

—

Mechanical risks

| — | Thermal risks (heat, flame and cold) |
| --- | --- |

—

Thermal risks (heat, flame and cold)

| — | Electric shock and live working (antistatic, conductive, insulating) |
| --- | --- |

—

Electric shock and live working (antistatic, conductive, insulating)

| — | Chemical risks |
| --- | --- |

—

Chemical risks

| — | Biological agents |
| --- | --- |

—

Biological agents

| — | Ionizing radiation and radioactive contamination |
| --- | --- |

—

Ionizing radiation and radioactive contamination

| — | Non-ionizing radiation (UV, IR, solar or welding radiation) |
| --- | --- |

—

Non-ionizing radiation (UV, IR, solar or welding radiation)

| — | Vibration risks |
| --- | --- |

—

Vibration risks

| — | Finger stalls |
| --- | --- |

—

Finger stalls

Equipment for FOOT AND LEG PROTECTION and anti-slip protection

| — | Footwear (e.g. shoes, including in certain circumstances clogs, boots that may have steel toe-caps) to protect against:






  — | Mechanical risks |
| --- | --- | --- |

—

Footwear (e.g. shoes, including in certain circumstances clogs, boots that may have steel toe-caps) to protect against:

—

Mechanical risks

| — | Slipping risks |
| --- | --- |

—

Slipping risks

| — | Thermal risks (heat, flame and cold) |
| --- | --- |

—

Thermal risks (heat, flame and cold)

| — | Electric shock and live working (antistatic, conductive, insulating) |
| --- | --- |

—

Electric shock and live working (antistatic, conductive, insulating)

| — | Chemicals risks |
| --- | --- |

—

Chemicals risks

| — | Vibration risks |
| --- | --- |

—

Vibration risks

| — | Biological risks |
| --- | --- |

—

Biological risks

| — | Removable instep protectors against mechanical risks |
| --- | --- |

—

Removable instep protectors against mechanical risks

| — | Kneepads against mechanical risks |
| --- | --- |

—

Kneepads against mechanical risks

| — | Gaiters against mechanical, thermal and chemical risks and biological agents |
| --- | --- |

—

Gaiters against mechanical, thermal and chemical risks and biological agents

| — | Accessories (e.g. spikes, crampons) |
| --- | --- |

—

Accessories (e.g. spikes, crampons)

SKIN PROTECTION — BARRIER CREAMS

   (1)

| — | There could be barrier creams to protect against:






  — | Non ionizing radiation (UV, IR, solar or welding radiation) |
| --- | --- | --- |

—

There could be barrier creams to protect against:

—

Non ionizing radiation (UV, IR, solar or welding radiation)

| — | Ionizing radiation |
| --- | --- |

—

Ionizing radiation

| — | Chemicals |
| --- | --- |

—

Chemicals

| — | Biological agents |
| --- | --- |

—

Biological agents

| — | Thermal risks (heat, flame and cold) |
| --- | --- |

—

Thermal risks (heat, flame and cold)

Equipment for BODY PROTECTION/OTHER SKIN PROTECTION

| — | Personal protective equipment for protection against falls from a height, such as retractable type fall arresters, full body harnesses, sit harnesses, belts for work positioning and restraint and work positioning lanyards, energy absorbers, guided-type fall arresters including an anchor line, rope adjustment devices, anchor devices that are not designed to be permanently fixed and that do not require fastening works before use, connectors, lanyards, rescue harness |
| --- | --- |

—

Personal protective equipment for protection against falls from a height, such as retractable type fall arresters, full body harnesses, sit harnesses, belts for work positioning and restraint and work positioning lanyards, energy absorbers, guided-type fall arresters including an anchor line, rope adjustment devices, anchor devices that are not designed to be permanently fixed and that do not require fastening works before use, connectors, lanyards, rescue harness

| — | Protective clothing, including whole body (i.e. suits, overalls) protection and partial body (i.e. gaiters, trousers, jackets, waistcoats, aprons, kneepads, hoods, balaclavas) protection against:






  — | Mechanical risks |
| --- | --- | --- |

—

Protective clothing, including whole body (i.e. suits, overalls) protection and partial body (i.e. gaiters, trousers, jackets, waistcoats, aprons, kneepads, hoods, balaclavas) protection against:

—

Mechanical risks

| — | Thermal risks (heat, flame and cold) |
| --- | --- |

—

Thermal risks (heat, flame and cold)

| — | Chemicals |
| --- | --- |

—

Chemicals

| — | Biological agents |
| --- | --- |

—

Biological agents

| — | Ionizing radiation and radioactive contamination |
| --- | --- |

—

Ionizing radiation and radioactive contamination

| — | Non-ionizing radiation (UV, IR, solar or welding radiation) |
| --- | --- |

—

Non-ionizing radiation (UV, IR, solar or welding radiation)

| — | Electric shock and live working (antistatic, conductive, insulating) |
| --- | --- |

—

Electric shock and live working (antistatic, conductive, insulating)

| — | Entanglement and trapping |
| --- | --- |

—

Entanglement and trapping

| — | Lifejackets for prevention of drowning and buoyancy aids |
| --- | --- |

—

Lifejackets for prevention of drowning and buoyancy aids

| — | PPE for signalling the user’s presence visually |
| --- | --- |

—

PPE for signalling the user’s presence visually

(3)

Annex III to Directive 89/656/EEC is replaced by the following:

‘ANNEX III

NON-EXHAUSTIVE LIST OF ACTIVITIES AND SECTORS OF ACTIVITY WHICH MAY REQUIRE THE PROVISION OF PERSONAL PROTECTIVE EQUIPMENT (*)

(*) The risk assessment will determine the need to provide a PPE and its characteristics according to the provisions of this Directive

I.   PHYSICAL RISKS

| Risks | Body part affected
  Type of PPE | Examples of activities where the use of the corresponding type of PPE may be necessary (*) | Industry and Sectors |
| --- | --- | --- | --- |
| PHYSICAL — MECHANICAL |
| Impact caused by falling or ejected objects, collision with an obstacle and high-pressure jets | Cranium

  Protective helmet | — | Work on, underneath or in the vicinity of scaffolding and elevated workplaces |

Risks

Body part affected

Type of PPE

Examples of activities where the use of the corresponding type of PPE may be necessary (*)

Industry and Sectors

PHYSICAL — MECHANICAL

Impact caused by falling or ejected objects, collision with an obstacle and high-pressure jets

Cranium

Protective helmet

—

Work on, underneath or in the vicinity of scaffolding and elevated workplaces

| — | Carcase Work and road work |
| --- | --- |

—

Carcase Work and road work

| — | Formwork's erection and stripping |
| --- | --- |

—

Formwork's erection and stripping

| — | Scaffolding's assembly and installation |
| --- | --- |

—

Scaffolding's assembly and installation

| — | Assembly and installation works |
| --- | --- |

—

Assembly and installation works

| — | Demolitions |
| --- | --- |

—

Demolitions

| — | Blasting works |
| --- | --- |

—

Blasting works

| — | Work in pits, trenches, shafts and tunnels |
| --- | --- |

—

Work in pits, trenches, shafts and tunnels

| — | Work in the vicinity of lifts, lifting gear, cranes, and conveyors |
| --- | --- |

—

Work in the vicinity of lifts, lifting gear, cranes, and conveyors

| — | Works in underground workings, quarries, open diggings |
| --- | --- |

—

Works in underground workings, quarries, open diggings

| — | Work with industrial furnaces, containers, machinery, silos, bunkers and pipelines |
| --- | --- |

—

Work with industrial furnaces, containers, machinery, silos, bunkers and pipelines

| — | Slaughtering and Cutting line at slaughterhouses |
| --- | --- |

—

Slaughtering and Cutting line at slaughterhouses

| — | Load handling or Transport and storage |
| --- | --- |

—

Load handling or Transport and storage

| — | Forest work |
| --- | --- |

—

Forest work

| — | Work on steel bridges, steel building construction, steel hydraulic structures, blast furnaces, steel works and rolling mills, large containers, large pipelines, boiler plants and power stations |
| --- | --- |

—

Work on steel bridges, steel building construction, steel hydraulic structures, blast furnaces, steel works and rolling mills, large containers, large pipelines, boiler plants and power stations

| — | Earth and rock works |
| --- | --- |

—

Earth and rock works

| — | Work with bolt-driving tools |
| --- | --- |

—

Work with bolt-driving tools

| — | Work with blast furnaces, direct reduction plants, steelworks, rolling mills, metalworks, forging, drop forging and casting |
| --- | --- |

—

Work with blast furnaces, direct reduction plants, steelworks, rolling mills, metalworks, forging, drop forging and casting

| — | Work involving travelling on bicycles and mechanically propelled bikes |
| --- | --- |

—

Work involving travelling on bicycles and mechanically propelled bikes

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Machinery manufacturing, installation and maintenance |
| --- | --- |

—

Machinery manufacturing, installation and maintenance

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Energy production |
| --- | --- |

—

Energy production

| — | Infrastructure construction and maintenance |
| --- | --- |

—

Infrastructure construction and maintenance

| — | Iron and Steel industry |
| --- | --- |

—

Iron and Steel industry

| — | Slaughterhouses |
| --- | --- |

—

Slaughterhouses

| — | Railway shunting work |
| --- | --- |

—

Railway shunting work

| — | Harbours, transport and logistics |
| --- | --- |

—

Harbours, transport and logistics

| — | Forest Industry |
| --- | --- |

—

Forest Industry

Eyes and/or face

Spectacles, goggles and face shields

| — | Welding, grinding and separating work |
| --- | --- |

—

Welding, grinding and separating work

| — | Manual hammering |
| --- | --- |

—

Manual hammering

| — | Caulking and chiselling |
| --- | --- |

—

Caulking and chiselling

| — | Rock working and processing |
| --- | --- |

—

Rock working and processing

| — | Work with bolt-driving tools |
| --- | --- |

—

Work with bolt-driving tools

| — | Work on stock removing machines for small chippings |
| --- | --- |

—

Work on stock removing machines for small chippings

| — | Drop forging |
| --- | --- |

—

Drop forging

| — | The removal and breaking up of fragments |
| --- | --- |

—

The removal and breaking up of fragments

| — | Spraying of abrasive substances |
| --- | --- |

—

Spraying of abrasive substances

| — | Use of brush cutter or chainsaw |
| --- | --- |

—

Use of brush cutter or chainsaw

| — | Dental and surgical procedures |
| --- | --- |

—

Dental and surgical procedures

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Machinery manufacturing, installation and maintenance |
| --- | --- |

—

Machinery manufacturing, installation and maintenance

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Energy production |
| --- | --- |

—

Energy production

| — | Infrastructure construction and maintenance |
| --- | --- |

—

Infrastructure construction and maintenance

| — | Iron and Steel industries |
| --- | --- |

—

Iron and Steel industries

| — | Metal and Wood industries |
| --- | --- |

—

Metal and Wood industries

| — | Stone carving |
| --- | --- |

—

Stone carving

| — | Gardening |
| --- | --- |

—

Gardening

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Forestry |
| --- | --- |

—

Forestry

Foot and leg (parts)

Footwear (shoes/boots, etc.) with safety or protective toecap

Footwear with metatarsal protection

| — | Carcase Work and road work |
| --- | --- |

—

Carcase Work and road work

| — | Erection and stripping of formwork |
| --- | --- |

—

Erection and stripping of formwork

| — | Scaffolding's assembly and installation |
| --- | --- |

—

Scaffolding's assembly and installation

| — | Demolitions |
| --- | --- |

—

Demolitions

| — | Blasting works |
| --- | --- |

—

Blasting works

| — | Working and processing of rock |
| --- | --- |

—

Working and processing of rock

| — | Slaughtering and Cutting line works |
| --- | --- |

—

Slaughtering and Cutting line works

| — | Transport and storage |
| --- | --- |

—

Transport and storage

| — | Work with moulds in the ceramics industry |
| --- | --- |

—

Work with moulds in the ceramics industry

| — | Work with frozen meat blocks and preserved foods packaging |
| --- | --- |

—

Work with frozen meat blocks and preserved foods packaging

| — | Flat glass products and container glassware manufacture, working and processing |
| --- | --- |

—

Flat glass products and container glassware manufacture, working and processing

| — | Conversion and maintenance work |
| --- | --- |

—

Conversion and maintenance work

| — | Forest works |
| --- | --- |

—

Forest works

| — | Work with concrete and prefabricated parts involving formwork erection and stripping |
| --- | --- |

—

Work with concrete and prefabricated parts involving formwork erection and stripping

| — | Work in contractors’ yards and warehouses |
| --- | --- |

—

Work in contractors’ yards and warehouses

| — | Roof work |
| --- | --- |

—

Roof work

| — | Work on steel bridges, steel building construction, masts, towers, lifts, steel hydraulic structures, blast furnaces, steelworks and rolling mills, large containers, large pipelines, cranes, boiler plants and power stations |
| --- | --- |

—

Work on steel bridges, steel building construction, masts, towers, lifts, steel hydraulic structures, blast furnaces, steelworks and rolling mills, large containers, large pipelines, cranes, boiler plants and power stations

| — | Furnace construction, heating and ventilation installation and metal assembly work |
| --- | --- |

—

Furnace construction, heating and ventilation installation and metal assembly work

| — | Work with blast furnaces, direct reduction plants, steelworks, rolling mills, metal works, forging, drop forging, hot pressing and drawing plants |
| --- | --- |

—

Work with blast furnaces, direct reduction plants, steelworks, rolling mills, metal works, forging, drop forging, hot pressing and drawing plants

| — | Work in quarries and open diggings, coal stock removal |
| --- | --- |

—

Work in quarries and open diggings, coal stock removal

| — | Work with moulds in the ceramics industry |
| --- | --- |

—

Work with moulds in the ceramics industry

| — | Lining of kilns in the ceramics industry |
| --- | --- |

—

Lining of kilns in the ceramics industry

| — | Railway shunting work |
| --- | --- |

—

Railway shunting work

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Machinery manufacturing, installation and maintenance |
| --- | --- |

—

Machinery manufacturing, installation and maintenance

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Energy production |
| --- | --- |

—

Energy production

| — | Infrastructure construction and maintenance |
| --- | --- |

—

Infrastructure construction and maintenance

| — | Iron and Steel industry |
| --- | --- |

—

Iron and Steel industry

| — | Slaughterhouses |
| --- | --- |

—

Slaughterhouses

| — | Logistic Companies |
| --- | --- |

—

Logistic Companies

| — | Manufacturing Industry |
| --- | --- |

—

Manufacturing Industry

| — | Glass Industry |
| --- | --- |

—

Glass Industry

| — | Forest Industry |
| --- | --- |

—

Forest Industry

Falls due to slipping

Foot

Slip-resistant footwear

| — | Works on slippery surfaces |
| --- | --- |

—

Works on slippery surfaces

| — | Works on humidity environments |
| --- | --- |

—

Works on humidity environments

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Slaughterhouse |
| --- | --- |

—

Slaughterhouse

| — | Cleaning |
| --- | --- |

—

Cleaning

| — | Food industries |
| --- | --- |

—

Food industries

| — | Gardening |
| --- | --- |

—

Gardening

| — | Fishing industry |
| --- | --- |

—

Fishing industry

Falls from a height

Whole body

PPE designed to prevent or arrest falls from height

| — | Work on scaffolding |
| --- | --- |

—

Work on scaffolding

| — | Assembly of prefabricated parts |
| --- | --- |

—

Assembly of prefabricated parts

| — | Works on masts |
| --- | --- |

—

Works on masts

| — | Roof work |
| --- | --- |

—

Roof work

| — | Work on vertical or slope surfaces |
| --- | --- |

—

Work on vertical or slope surfaces

| — | Work in high crane cabs |
| --- | --- |

—

Work in high crane cabs

| — | Work in high cabs of warehouse stacking and retrieval equipment |
| --- | --- |

—

Work in high cabs of warehouse stacking and retrieval equipment

| — | Work in high sections of drilling towers |
| --- | --- |

—

Work in high sections of drilling towers

| — | Work in shafts and sewers |
| --- | --- |

—

Work in shafts and sewers

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Infrastructure maintenance |
| --- | --- |

—

Infrastructure maintenance

Vibration

Hands

Protective Gloves

| — | Works with hand-guided tools |
| --- | --- |

—

Works with hand-guided tools

| — | Manufacturing industries |
| --- | --- |

—

Manufacturing industries

| — | Building work |
| --- | --- |

—

Building work

| — | Civil Engineering work |
| --- | --- |

—

Civil Engineering work

Static compression of parts of the body

Knee (leg parts)

Kneepads

| — | Installation of blocks, tiles and pavers on the floor |
| --- | --- |

—

Installation of blocks, tiles and pavers on the floor

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

Foot

Footwear with toecaps

| — | Demolitions |
| --- | --- |

—

Demolitions

| — | Load handling |
| --- | --- |

—

Load handling

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Transport and storage |
| --- | --- |

—

Transport and storage

| — | Maintenance |
| --- | --- |

—

Maintenance

Mechanical injuries (abrasion, perforation, cuts, bites, wounds or stabs)

Eyes and/or face

Spectacles, goggles, face shields

| — | Works with hand-guided tools |
| --- | --- |

—

Works with hand-guided tools

| — | Welding and forging |
| --- | --- |

—

Welding and forging

| — | Grinding and separating work |
| --- | --- |

—

Grinding and separating work

| — | Chiselling |
| --- | --- |

—

Chiselling

| — | Rock working and processing |
| --- | --- |

—

Rock working and processing

| — | Work on stock removing machines for small chippings |
| --- | --- |

—

Work on stock removing machines for small chippings

| — | Drop forging |
| --- | --- |

—

Drop forging

| — | The removal and breaking up of fragments |
| --- | --- |

—

The removal and breaking up of fragments

| — | Spraying of abrasive substances |
| --- | --- |

—

Spraying of abrasive substances

| — | Use of brush cutter or chainsaw |
| --- | --- |

—

Use of brush cutter or chainsaw

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Energy production |
| --- | --- |

—

Energy production

| — | Infrastructure maintenance |
| --- | --- |

—

Infrastructure maintenance

| — | Iron and Steel industries |
| --- | --- |

—

Iron and Steel industries

| — | Metal and Wood industries |
| --- | --- |

—

Metal and Wood industries

| — | Stone carving |
| --- | --- |

—

Stone carving

| — | Gardening |
| --- | --- |

—

Gardening

| — | Forestry |
| --- | --- |

—

Forestry

Hands

Mechanical protective gloves

| — | Works with steel framework |
| --- | --- |

—

Works with steel framework

| — | Handling of sharp-edged objects, other than machines where there is a danger of the gloves being caught |
| --- | --- |

—

Handling of sharp-edged objects, other than machines where there is a danger of the gloves being caught

| — | Regular cutting using a hand knife for production and slaughtering |
| --- | --- |

—

Regular cutting using a hand knife for production and slaughtering

| — | Changing the knives of cutting machines |
| --- | --- |

—

Changing the knives of cutting machines

| — | Forest works |
| --- | --- |

—

Forest works

| — | Gardening work |
| --- | --- |

—

Gardening work

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Infrastructure maintenance |
| --- | --- |

—

Infrastructure maintenance

| — | Manufacturing industries |
| --- | --- |

—

Manufacturing industries

| — | Food industry |
| --- | --- |

—

Food industry

| — | Slaughter |
| --- | --- |

—

Slaughter

| — | Forest industry |
| --- | --- |

—

Forest industry

Forearms

Arm protection

| — | Boning and cutting |
| --- | --- |

—

Boning and cutting

| — | Food industry |
| --- | --- |

—

Food industry

| — | Slaughter |
| --- | --- |

—

Slaughter

Trunk/Abdomen/Leg

Protective apron, gaiters

Penetration resistance trousers (cut-resistant trousers)

| — | Regular cutting using a hand knife for production and slaughtering |
| --- | --- |

—

Regular cutting using a hand knife for production and slaughtering

| — | Forest works |
| --- | --- |

—

Forest works

| — | Food industry |
| --- | --- |

—

Food industry

| — | Slaughter |
| --- | --- |

—

Slaughter

| — | Forest industry |
| --- | --- |

—

Forest industry

Foot

Penetration resistance footwear

| — | Carcase works and road works |
| --- | --- |

—

Carcase works and road works

| — | Demolition |
| --- | --- |

—

Demolition

| — | Formwork's erection and stripping |
| --- | --- |

—

Formwork's erection and stripping

| — | Forest works |
| --- | --- |

—

Forest works

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Forest industry |
| --- | --- |

—

Forest industry

Entanglement and trapping

Whole body

Protective clothing for use where there is a risk of entanglement with moving parts

| — | Entangle oneself in parts of machines |
| --- | --- |

—

Entangle oneself in parts of machines

| — | Get caught in parts of machines |
| --- | --- |

—

Get caught in parts of machines

| — | Get caught with garment in parts of machines |
| --- | --- |

—

Get caught with garment in parts of machines

| — | Get swept away |
| --- | --- |

—

Get swept away

| — | Machine building |
| --- | --- |

—

Machine building

| — | Manufacture of heavy-duty machines |
| --- | --- |

—

Manufacture of heavy-duty machines

| — | Engineering |
| --- | --- |

—

Engineering

| — | Construction |
| --- | --- |

—

Construction

| — | Agriculture |
| --- | --- |

—

Agriculture

PHYSICAL — NOISE

Noise

Ears

Hearing protectors

| — | Work with metal presses |
| --- | --- |

—

Work with metal presses

| — | Work with pneumatic drills |
| --- | --- |

—

Work with pneumatic drills

| — | The work of ground staff at airports |
| --- | --- |

—

The work of ground staff at airports

| — | Works with power tools |
| --- | --- |

—

Works with power tools

| — | Blasting works |
| --- | --- |

—

Blasting works

| — | Pile-driving work |
| --- | --- |

—

Pile-driving work

| — | Wood and textile working |
| --- | --- |

—

Wood and textile working

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Aeronautical industry |
| --- | --- |

—

Aeronautical industry

| — | Mining works |
| --- | --- |

—

Mining works

PHYSICAL — THERMAL

Heat and/or fire

Face/Whole head

Welding headshields,

helmets/caps against heat or fire, protective hoods against heat and/or flame

| — | Work in presence of high temperatures, radiating heat or fire |
| --- | --- |

—

Work in presence of high temperatures, radiating heat or fire

| — | Work with or in the vicinity of molten substances |
| --- | --- |

—

Work with or in the vicinity of molten substances

| — | Work with welding plastics guns |
| --- | --- |

—

Work with welding plastics guns

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Maintenance services |
| --- | --- |

—

Maintenance services

| — | Manufacturing Industry |
| --- | --- |

—

Manufacturing Industry

Trunk/abdomen/legs

Protective apron, gaiters

| — | Welding and forging |
| --- | --- |

—

Welding and forging

| — | Casting |
| --- | --- |

—

Casting

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Maintenance services |
| --- | --- |

—

Maintenance services

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

Hand

Protective gloves against heat and/or flame

| — | Welding and forging |
| --- | --- |

—

Welding and forging

| — | Work in presence of high temperatures, radiating heat or fire |
| --- | --- |

—

Work in presence of high temperatures, radiating heat or fire

| — | Work with or in the vicinity of molten substances |
| --- | --- |

—

Work with or in the vicinity of molten substances

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Maintenance services |
| --- | --- |

—

Maintenance services

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

Forearms

Sleeves

| — | Welding and forging |
| --- | --- |

—

Welding and forging

| — | Work with or in the vicinity of molten substances |
| --- | --- |

—

Work with or in the vicinity of molten substances

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Maintenance services |
| --- | --- |

—

Maintenance services

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

Foot

Footwear against heat and/or flame

| — | Work with or in the vicinity of molten substances |
| --- | --- |

—

Work with or in the vicinity of molten substances

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Maintenance services |
| --- | --- |

—

Maintenance services

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

Whole/partial body

Protective clothing against heat and/or flame

| — | Work in presence of high temperatures, radiating heat or fire |
| --- | --- |

—

Work in presence of high temperatures, radiating heat or fire

| — | Iron and Steel Industry |
| --- | --- |

—

Iron and Steel Industry

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Forest Industry |
| --- | --- |

—

Forest Industry

Cold

Hand

Protective gloves against cold

Foot

Footwear against cold

| — | Work in the open air in extreme cold conditions |
| --- | --- |

—

Work in the open air in extreme cold conditions

| — | Work in deep-freeze rooms |
| --- | --- |

—

Work in deep-freeze rooms

| — | Work with cryogenic liquids |
| --- | --- |

—

Work with cryogenic liquids

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Food Industry |
| --- | --- |

—

Food Industry

| — | Agriculture and fisheries sector |
| --- | --- |

—

Agriculture and fisheries sector

Whole/partial body including head

Protective clothing against cold

| — | Work in the open air in cold weather conditions |
| --- | --- |

—

Work in the open air in cold weather conditions

| — | Work in deep-freeze rooms |
| --- | --- |

—

Work in deep-freeze rooms

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Food Industry |
| --- | --- |

—

Food Industry

| — | Agriculture and fisheries sector |
| --- | --- |

—

Agriculture and fisheries sector

| — | Transport and storage |
| --- | --- |

—

Transport and storage

PHYSICAL — ELECTRICAL

Electric shock (direct or indirect contact)

Whole head

Electrically insulating helmets

Hands

Electrically insulating gloves

Foot

Electrically insulating footwear

Whole body/Hands/Foot

Conductive PPE intended to be worn by skilled persons during live working at a nominal power system voltage up to 800 kV AC and 600 kV DC

| — | Live working or close to live parts under electrical tension |
| --- | --- |

—

Live working or close to live parts under electrical tension

| — | Work on electrical system |
| --- | --- |

—

Work on electrical system

| — | Energy production |
| --- | --- |

—

Energy production

| — | Transmission and distribution of electrical energy |
| --- | --- |

—

Transmission and distribution of electrical energy

| — | Industrial facilities maintenance |
| --- | --- |

—

Industrial facilities maintenance

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

Static electricity

Hands

Antistatic gloves

Foot

Antistatic/conductivefootwear

Whole body

Antistatic clothing

| — | Handling plastic and rubber |
| --- | --- |

—

Handling plastic and rubber

| — | Pouring, collecting or loading into a container |
| --- | --- |

—

Pouring, collecting or loading into a container

| — | Work near to highly charged elements such as conveyor belts |
| --- | --- |

—

Work near to highly charged elements such as conveyor belts

| — | Handling explosives |
| --- | --- |

—

Handling explosives

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Feed industry |
| --- | --- |

—

Feed industry

| — | Bagging and packing plants |
| --- | --- |

—

Bagging and packing plants

| — | Production, storage or transport of explosives |
| --- | --- |

—

Production, storage or transport of explosives

PHYSICAL — RADIATION

Non-ionizing radiation, including sunlight (other than direct observation)

Head

Caps and helmets

| — | Work in open air |
| --- | --- |

—

Work in open air

| — | Fishing and agriculture |
| --- | --- |

—

Fishing and agriculture

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

Eyes

Protective spectacles, goggles and face shields

| — | Work with radiant heat |
| --- | --- |

—

Work with radiant heat

| — | Furnace operations |
| --- | --- |

—

Furnace operations

| — | Work with laser |
| --- | --- |

—

Work with laser

| — | Work in open air |
| --- | --- |

—

Work in open air

| — | Welding and gas cutting |
| --- | --- |

—

Welding and gas cutting

| — | Glass blowing |
| --- | --- |

—

Glass blowing

| — | Germicidal lamps |
| --- | --- |

—

Germicidal lamps

| — | Iron and Steel Industries |
| --- | --- |

—

Iron and Steel Industries

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Fishing and agriculture |
| --- | --- |

—

Fishing and agriculture

Whole body (skin)

PPE against

Natural and artificial UV

| — | Work in the open air |
| --- | --- |

—

Work in the open air

| — | Electrical welding |
| --- | --- |

—

Electrical welding

| — | Germicidal lamps |
| --- | --- |

—

Germicidal lamps

| — | Xenon lamps |
| --- | --- |

—

Xenon lamps

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Energy production |
| --- | --- |

—

Energy production

| — | Infrastructure maintenance |
| --- | --- |

—

Infrastructure maintenance

| — | Fishing and agriculture |
| --- | --- |

—

Fishing and agriculture

| — | Forest industry |
| --- | --- |

—

Forest industry

| — | Gardening |
| --- | --- |

—

Gardening

| — | Food industry |
| --- | --- |

—

Food industry

| — | Plastic industry |
| --- | --- |

—

Plastic industry

| — | Printing industry |
| --- | --- |

—

Printing industry

Ionizing radiation

Eyes

Protective spectacles/goggles against ionizing radiation

Hands

Protective gloves against ionizing radiation

| — | Operating in X-ray facilities |
| --- | --- |

—

Operating in X-ray facilities

| — | Operating in the area of medical radio diagnosis |
| --- | --- |

—

Operating in the area of medical radio diagnosis

| — | Work with radioactive products |
| --- | --- |

—

Work with radioactive products

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary care |
| --- | --- |

—

Veterinary care

| — | Radioactive waste plant |
| --- | --- |

—

Radioactive waste plant

| — | Energy production |
| --- | --- |

—

Energy production

Trunk/abdomen/partial body

Protective apron against x-rays

/Coat/Vest/Skirt against x-rays

| — | Operating in X-ray facilities |
| --- | --- |

—

Operating in X-ray facilities

| — | Operating in the area of medical radio diagnosis |
| --- | --- |

—

Operating in the area of medical radio diagnosis

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary care |
| --- | --- |

—

Veterinary care

| — | Dental care |
| --- | --- |

—

Dental care

| — | Urology |
| --- | --- |

—

Urology

| — | Surgery |
| --- | --- |

—

Surgery

| — | Interventional radiology |
| --- | --- |

—

Interventional radiology

| — | Laboratories |
| --- | --- |

—

Laboratories

Head

Headwear & Caps

PPE for protection against e.g. development of brain tumours

| — | Medical X-ray work places and facilities |
| --- | --- |

—

Medical X-ray work places and facilities

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary care |
| --- | --- |

—

Veterinary care

| — | Dental care |
| --- | --- |

—

Dental care

| — | Urology |
| --- | --- |

—

Urology

| — | Surgery |
| --- | --- |

—

Surgery

| — | Interventional radiology |
| --- | --- |

—

Interventional radiology

Partial body

PPE for thyroid protection

PPE for gonads protection

| — | Operating in X-ray facilities |
| --- | --- |

—

Operating in X-ray facilities

| — | Operating in the area of medical radio diagnosis |
| --- | --- |

—

Operating in the area of medical radio diagnosis

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary care |
| --- | --- |

—

Veterinary care

Whole body

Protective clothing against ionizing radiation

| — | Operating in the area of medical radio diagnosis |
| --- | --- |

—

Operating in the area of medical radio diagnosis

| — | Work with radioactive products |
| --- | --- |

—

Work with radioactive products

| — | Energy production |
| --- | --- |

—

Energy production

| — | Radioactive waste plant |
| --- | --- |

—

Radioactive waste plant

II.   CHEMICAL RISKS (including nanomaterial)

| Risks | Body part affected
  Type of PPE | Examples of activities where the use of the corresponding type of PPE may be necessary (*) | Industry and Sectors |
| --- | --- | --- | --- |
| CHEMICAL — AEROSOLS |
| Solid (dusts, fumes, smokes, fibres,


  and nano-material) | Respiratory system

  Respiratory protective devices against particles | — | Demolition |

Risks

Body part affected

Type of PPE

Examples of activities where the use of the corresponding type of PPE may be necessary (*)

Industry and Sectors

CHEMICAL — AEROSOLS

Solid (dusts, fumes, smokes, fibres,

and nano-material)

Respiratory system

Respiratory protective devices against particles

—

Demolition

| — | Blasting works |
| --- | --- |

—

Blasting works

| — | Sanding and Polishing of surfaces |
| --- | --- |

—

Sanding and Polishing of surfaces

| — | Work in presence of asbestos |
| --- | --- |

—

Work in presence of asbestos

| — | Use of materials consisting of/containing nanoparticles |
| --- | --- |

—

Use of materials consisting of/containing nanoparticles

| — | Welding |
| --- | --- |

—

Welding

| — | Chimney sweeper |
| --- | --- |

—

Chimney sweeper

| — | Work on the lining of furnaces and ladles where there may be dust |
| --- | --- |

—

Work on the lining of furnaces and ladles where there may be dust

| — | Work in the vicinity of blast furnace taps where there may be heavy metal fumes |
| --- | --- |

—

Work in the vicinity of blast furnace taps where there may be heavy metal fumes

| — | Work in the vicinity of the blast furnace charge |
| --- | --- |

—

Work in the vicinity of the blast furnace charge

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Iron and Steel industries |
| --- | --- |

—

Iron and Steel industries

| — | Metal and Wood industries |
| --- | --- |

—

Metal and Wood industries

| — | Automotive industry |
| --- | --- |

—

Automotive industry

| — | Stone carving |
| --- | --- |

—

Stone carving

| — | Pharmaceuticals industry |
| --- | --- |

—

Pharmaceuticals industry

| — | Healthcare services |
| --- | --- |

—

Healthcare services

| — | Preparation of cytostatics |
| --- | --- |

—

Preparation of cytostatics

Hands

Chemical Protective gloves

and barrier cream as an additional/accessory protection

| — | Work in presence of asbestos |
| --- | --- |

—

Work in presence of asbestos

| — | Use of materials consisting of/containing nanoparticles |
| --- | --- |

—

Use of materials consisting of/containing nanoparticles

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Industrial facilities maintenance |
| --- | --- |

—

Industrial facilities maintenance

Whole body

Protective clothing against solid particles

| — | Demolition |
| --- | --- |

—

Demolition

| — | Work in presence of asbestos |
| --- | --- |

—

Work in presence of asbestos

| — | Use of materials consisting of/containing nanoparticles |
| --- | --- |

—

Use of materials consisting of/containing nanoparticles

| — | Chimney sweeper |
| --- | --- |

—

Chimney sweeper

| — | Preparation of plant protection products |
| --- | --- |

—

Preparation of plant protection products

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Industrial facilities maintenance |
| --- | --- |

—

Industrial facilities maintenance

| — | Agriculture |
| --- | --- |

—

Agriculture

Eyes

Spectacles/goggles and face shields

| — | Woodworking |
| --- | --- |

—

Woodworking

| — | Road work |
| --- | --- |

—

Road work

| — | Mining industry |
| --- | --- |

—

Mining industry

| — | Metal and wood industry |
| --- | --- |

—

Metal and wood industry

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

Liquid

(mists and fogs)

Respiratory system

Respiratory protective devices against particles

| — | Surface treatment (e.g. varnishing/painting, abrasive blasting) |
| --- | --- |

—

Surface treatment (e.g. varnishing/painting, abrasive blasting)

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Manufacturing Industry |
| --- | --- |

—

Manufacturing Industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

Hands

Chemical protective gloves

| — | Surface treatment |
| --- | --- |

—

Surface treatment

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Work with liquid sprays |
| --- | --- |

—

Work with liquid sprays

| — | Works with acids and caustic solutions, disinfectants and corrosive cleaning substances |
| --- | --- |

—

Works with acids and caustic solutions, disinfectants and corrosive cleaning substances

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

Whole body

Chemical protective clothing

| — | Surface treatment |
| --- | --- |

—

Surface treatment

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

CHEMICAL — LIQUIDS

Immersion

Splashes, sprays and jets

Hands

Chemical protective gloves,

| — | Work with liquid sprays |
| --- | --- |

—

Work with liquid sprays

| — | Works with acids and caustic solutions, disinfectants and corrosive cleaning products |
| --- | --- |

—

Works with acids and caustic solutions, disinfectants and corrosive cleaning products

| — | Processing of coating materials |
| --- | --- |

—

Processing of coating materials

| — | Tanning |
| --- | --- |

—

Tanning

| — | Work in hairdressers and beauty salons |
| --- | --- |

—

Work in hairdressers and beauty salons

| — | Textile and clothing industry |
| --- | --- |

—

Textile and clothing industry

| — | Cleaning industry |
| --- | --- |

—

Cleaning industry

| — | Automobile industry |
| --- | --- |

—

Automobile industry

| — | Beauty and hairdressing sectors |
| --- | --- |

—

Beauty and hairdressing sectors

Forearms

Chemical protective sleeves

| — | Works with acids and caustic solutions, disinfectants and corrosive cleaning products |
| --- | --- |

—

Works with acids and caustic solutions, disinfectants and corrosive cleaning products

| — | Cleaning |
| --- | --- |

—

Cleaning

| — | Chemical industry |
| --- | --- |

—

Chemical industry

| — | Cleaning industry |
| --- | --- |

—

Cleaning industry

| — | Automobile industry |
| --- | --- |

—

Automobile industry

Foot

Chemical protective boots

| — | Work with liquid sprays |
| --- | --- |

—

Work with liquid sprays

| — | Works with acids and caustic solutions, disinfectants and corrosive cleaning products |
| --- | --- |

—

Works with acids and caustic solutions, disinfectants and corrosive cleaning products

| — | Textile and clothing industry |
| --- | --- |

—

Textile and clothing industry

| — | Cleaning industry |
| --- | --- |

—

Cleaning industry

| — | Automobile industry |
| --- | --- |

—

Automobile industry

Whole body

Chemical protectiveclothing

| — | Work with liquid sprays |
| --- | --- |

—

Work with liquid sprays

| — | Works with acids and caustic solutions, disinfectants and corrosive cleaning products |
| --- | --- |

—

Works with acids and caustic solutions, disinfectants and corrosive cleaning products

| — | Cleaning |
| --- | --- |

—

Cleaning

| — | Chemical industry |
| --- | --- |

—

Chemical industry

| — | Cleaning industry |
| --- | --- |

—

Cleaning industry

| — | Automobile industry |
| --- | --- |

—

Automobile industry

| — | Agriculture |
| --- | --- |

—

Agriculture

CHEMICAL — GASES AND VAPOURS

Gases and vapours

Respiratory system

Respiratory protective devices against gases

| — | Surface treatment (e.g. varnishing/painting, abrasive blasting) |
| --- | --- |

—

Surface treatment (e.g. varnishing/painting, abrasive blasting)

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Work in fermentation and distilling rooms |
| --- | --- |

—

Work in fermentation and distilling rooms

| — | Work inside tanks and digesters |
| --- | --- |

—

Work inside tanks and digesters

| — | Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen |
| --- | --- |

—

Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen

| — | Chimney sweeper |
| --- | --- |

—

Chimney sweeper

| — | Disinfectants and corrosive cleaning substances |
| --- | --- |

—

Disinfectants and corrosive cleaning substances

| — | Work in the vicinity of gas converters and blast furnace gas pipes |
| --- | --- |

—

Work in the vicinity of gas converters and blast furnace gas pipes

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Cleaning industry |
| --- | --- |

—

Cleaning industry

| — | Alcoholic drinks production |
| --- | --- |

—

Alcoholic drinks production

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Chemical Industry |
| --- | --- |

—

Chemical Industry

| — | Petrochemical industry |
| --- | --- |

—

Petrochemical industry

Hands

Chemical protective gloves

| — | Surface treatment |
| --- | --- |

—

Surface treatment

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Work in fermentation and distilling rooms |
| --- | --- |

—

Work in fermentation and distilling rooms

| — | Work inside tanks and digesters |
| --- | --- |

—

Work inside tanks and digesters

| — | Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen |
| --- | --- |

—

Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Alcoholic drinks production |
| --- | --- |

—

Alcoholic drinks production

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Chemical Industry |
| --- | --- |

—

Chemical Industry

| — | Petrochemical industry |
| --- | --- |

—

Petrochemical industry

Whole body

Chemical protective clothing

| — | Surface treatment |
| --- | --- |

—

Surface treatment

| — | Surface cleaning |
| --- | --- |

—

Surface cleaning

| — | Work in fermentation and distilling rooms |
| --- | --- |

—

Work in fermentation and distilling rooms

| — | Work inside tanks and digesters |
| --- | --- |

—

Work inside tanks and digesters

| — | Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen |
| --- | --- |

—

Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen

| — | Metal Industry |
| --- | --- |

—

Metal Industry

| — | Automotive sector |
| --- | --- |

—

Automotive sector

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Alcoholic drinks production |
| --- | --- |

—

Alcoholic drinks production

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Chemical Industry |
| --- | --- |

—

Chemical Industry

| — | Petrochemical industry |
| --- | --- |

—

Petrochemical industry

Eyes

Spectacles, goggles and face shields

| — | Spray painting |
| --- | --- |

—

Spray painting

| — | Woodworking |
| --- | --- |

—

Woodworking

| — | Mining operations |
| --- | --- |

—

Mining operations

| — | Automotive sector |
| --- | --- |

—

Automotive sector

| — | Manufacturing industry |
| --- | --- |

—

Manufacturing industry

| — | Mine industry |
| --- | --- |

—

Mine industry

| — | Chemical Industry |
| --- | --- |

—

Chemical Industry

| — | Petrochemical industry |
| --- | --- |

—

Petrochemical industry

III.   BIOLOGICAL AGENTS

| Risks | Body part affected
  Type of PPE | Examples of activities where the use of the corresponding type of PPE may be necessary (*) | Industry and Sectors |
| --- | --- | --- | --- |
| BIOLOGICAL AGENTS (contained in) - AEROSOLS |
| Solids and liquids | Respiratory system

  Respiratory protective devices against particles | — | Work that involve contact with human body and animal fluids and tissues |

Risks

Body part affected

Type of PPE

Examples of activities where the use of the corresponding type of PPE may be necessary (*)

Industry and Sectors

BIOLOGICAL AGENTS (contained in) - AEROSOLS

Solids and liquids

Respiratory system

Respiratory protective devices against particles

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

| — | Biochemical production |
| --- | --- |

—

Biochemical production

Hands

Protective gloves against microorganisms

Whole/partial body

Protective clothing against biological agents

Eyes and/or face

Protective spectacles, goggles and face shields

| — | Work that involve contact with human body and animal fluids and tissues |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

BIOLOGICAL AGENTS (contained in) - LIQUIDS

Direct and indirect contact

Hands

Protective gloves against microorganisms

Whole/partial body

Protective clothing against biological agents

Eyes and/or face

Protective goggles and face shields

| — | Work that involve contact with human body and animal fluids and tissues (bites, stings) |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues (bites, stings)

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

| — | Forest industry |
| --- | --- |

—

Forest industry

Splashes, sprays and jets

Hands

Protective gloves against microorganisms

| — | Work that involve contact with human body and animal fluids and tissues |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

Forearms

Protective sleeves against microorganisms

| — | Work that involve contact with human body and animal fluids and tissues |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

Foot/legs

Protective over boots and gaiters

| — | Work that involve contact with human body and animal fluids and tissues |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

Whole body

Protective clothing against biological agents

| — | Work that involve contact with human body and animal fluids and tissues |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

BIOLOGICAL AGENTS (contained in) – MATERIALS, PERSONS, ANIMALS, ETC.

Direct and indirect contact

Hands

Protective gloves against microorganisms

Whole/partial body

Protective clothing against biological agents

Eyes and/or face

Protective goggles and face shields

| — | Work that involve contact with human body and animal fluids and tissues (bites, stings) |
| --- | --- |

—

Work that involve contact with human body and animal fluids and tissues (bites, stings)

| — | Work in presence of biological agent |
| --- | --- |

—

Work in presence of biological agent

| — | Healthcare |
| --- | --- |

—

Healthcare

| — | Veterinary clinics |
| --- | --- |

—

Veterinary clinics

| — | Clinical analysis laboratories |
| --- | --- |

—

Clinical analysis laboratories

| — | Research Laboratories |
| --- | --- |

—

Research Laboratories

| — | Retirement homes |
| --- | --- |

—

Retirement homes

| — | Homes assistances |
| --- | --- |

—

Homes assistances

| — | Wastewater treatment plants |
| --- | --- |

—

Wastewater treatment plants

| — | Waste treatment plant |
| --- | --- |

—

Waste treatment plant

| — | Food Industry |
| --- | --- |

—

Food Industry

| — | Forest industry |
| --- | --- |

—

Forest industry

IV.   OTHER RISKS

| Risks | Body part affected
  Type of PPE | Examples of activities where the use of the corresponding type of PPE may be necessary (*) | Industry and Sectors |
| --- | --- | --- | --- |
| Non-visibility | Whole body

  PPE for signalling the user’s presence visually | — | Work in proximity of movement of vehicles |

Risks

Body part affected

Type of PPE

Examples of activities where the use of the corresponding type of PPE may be necessary (*)

Industry and Sectors

Non-visibility

Whole body

PPE for signalling the user’s presence visually

—

Work in proximity of movement of vehicles

| — | Asphalt works and road marking |
| --- | --- |

—

Asphalt works and road marking

| — | Railway works |
| --- | --- |

—

Railway works

| — | Driving means of transport |
| --- | --- |

—

Driving means of transport

| — | Work of ground staff at airport |
| --- | --- |

—

Work of ground staff at airport

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Mining works |
| --- | --- |

—

Mining works

| — | Transport services and passengers transports |
| --- | --- |

—

Transport services and passengers transports

Oxygen deficiency

Respiratory system

Insulating respiratory protectives devices

| — | Work in confined spaces |
| --- | --- |

—

Work in confined spaces

| — | Work in fermentation and distilling rooms |
| --- | --- |

—

Work in fermentation and distilling rooms

| — | Work inside tanks and digesters |
| --- | --- |

—

Work inside tanks and digesters

| — | Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen |
| --- | --- |

—

Work in containers, restricted areas and gas-fired industrial furnaces where there may be gas or insufficient oxygen

| — | Work in shafts, sewers and other underground areas connected with sewage |
| --- | --- |

—

Work in shafts, sewers and other underground areas connected with sewage

| — | Alcoholic drinks production |
| --- | --- |

—

Alcoholic drinks production

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Chemical Industry |
| --- | --- |

—

Chemical Industry

| — | Petrochemical industry |
| --- | --- |

—

Petrochemical industry

Respiratory system

Diving equipment

| — | Underwater works |
| --- | --- |

—

Underwater works

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

Drowning

Whole body

Life jacket

| — | Work on or near water |
| --- | --- |

—

Work on or near water

| — | Work in the sea |
| --- | --- |

—

Work in the sea

| — | Work in an airplane |
| --- | --- |

—

Work in an airplane

| — | Fishing industry |
| --- | --- |

—

Fishing industry

| — | Aeronautical industry |
| --- | --- |

—

Aeronautical industry

| — | Building construction |
| --- | --- |

—

Building construction

| — | Civil engineering construction |
| --- | --- |

—

Civil engineering construction

| — | Shipbuilding |
| --- | --- |

—

Shipbuilding

| — | Docks and harbours |
| --- | --- |

—

Docks and harbours

---

(1)  In certain circumstances, as a result of the risk assessment, barrier creams could be used together with other PPE with the aim of protecting workers’ skin from related risks. Barrier creams are PPE under the scope of Directive 89/656/EEC as this type of equipment can be considered in certain circumstances as “additional or accessory” within the meaning of Article 2 of Directive 89/656/EEC. However, barrier creams are not PPE according to the definition in Article 3(1) of Regulation (EU) 2016/425.

1

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/54 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/54

---

COMMISSION DIRECTIVE (EU) 2019/1833

of 24 October 2019

amending Annexes I, III, V and VI to Directive 2000/54/EC of the European Parliament and of the Council as regards purely technical adjustments

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (1), and in particular Article 19 thereof,

Whereas:

| (1) | Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes protection from exposure to biological agents at work. |
| --- | --- |

(1)

Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, provides that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes protection from exposure to biological agents at work.

| (2) | The implementation of the directives related to the health and safety of workers at work, including Directive 2000/54/EC, was the subject of an ex-post evaluation, referred to as a REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the classified list of biological agents in Annex III to Directive 2000/54/EC needs to be amended in light of scientific and technical progress and that consistency with other relevant directives should be enhanced. |
| --- | --- |

(2)

The implementation of the directives related to the health and safety of workers at work, including Directive 2000/54/EC, was the subject of an ex-post evaluation, referred to as a REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the classified list of biological agents in Annex III to Directive 2000/54/EC needs to be amended in light of scientific and technical progress and that consistency with other relevant directives should be enhanced.

| (3) | In its Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational health and safety confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of biological agents in Annex III to Directive 2000/54/EC. |
| --- | --- |

(3)

In its Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational health and safety confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of biological agents in Annex III to Directive 2000/54/EC.

| (4) | Directive 2000/54/EC lays down rules to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work. Directive 2000/54/EC applies to activities in which workers are exposed, or are potentially exposed, to biological agents as a result of their work, and states the measures to be taken in the case of any activity likely to involve a risk of exposure to biological agents, to determine the nature, degree and duration of workers’ exposure to biological agents. |
| --- | --- |

(4)

Directive 2000/54/EC lays down rules to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to biological agents at work. Directive 2000/54/EC applies to activities in which workers are exposed, or are potentially exposed, to biological agents as a result of their work, and states the measures to be taken in the case of any activity likely to involve a risk of exposure to biological agents, to determine the nature, degree and duration of workers’ exposure to biological agents.

| (5) | Since the results of a risk assessment can show an unintended exposure to biological agents, there could be other work activities not included in Annex I to Directive 2000/54/EC that should also be taken into consideration. Therefore, the indicative list of activities set out in Annex I to Directive 2000/54/EC should be amended to include an introductory phrase in order to clarify the non-exhaustive nature of the list. |
| --- | --- |

(5)

Since the results of a risk assessment can show an unintended exposure to biological agents, there could be other work activities not included in Annex I to Directive 2000/54/EC that should also be taken into consideration. Therefore, the indicative list of activities set out in Annex I to Directive 2000/54/EC should be amended to include an introductory phrase in order to clarify the non-exhaustive nature of the list.

| (6) | Annex III to Directive 2000/54/EC sets out the list of biological agents known to infect humans, classified according to their level of risk of infection. In line with introductory note 6 in that Annex, the list should be amended to take into account the latest state of knowledge as regards scientific development that have brought about significant changes since the list was last updated, particularly as regards the taxonomy, nomenclature, classification and characteristics of biological agents, and the existence of new biological agents. |
| --- | --- |

(6)

Annex III to Directive 2000/54/EC sets out the list of biological agents known to infect humans, classified according to their level of risk of infection. In line with introductory note 6 in that Annex, the list should be amended to take into account the latest state of knowledge as regards scientific development that have brought about significant changes since the list was last updated, particularly as regards the taxonomy, nomenclature, classification and characteristics of biological agents, and the existence of new biological agents.

| (7) | Annexes V and VI to Directive 2000/54/EC lay down the containment measures and levels for laboratories, animal facilities and industry. Annexes V and VI should be amended and restructured in order to be aligned with and to take into account the containment and other protective measures included in Directive 2009/41/EC of the European Parliament and of the Council (5). |
| --- | --- |

(7)

Annexes V and VI to Directive 2000/54/EC lay down the containment measures and levels for laboratories, animal facilities and industry. Annexes V and VI should be amended and restructured in order to be aligned with and to take into account the containment and other protective measures included in Directive 2009/41/EC of the European Parliament and of the Council (5).

| (8) | In preparing the current update of Annexes I, III V and VI to Directive 2000/54/EC, consideration was given to the need to maintain the existing levels of protection for workers who are or who are potentially exposed to biological agents through their work, and to ensure that the amendments only take into account scientific developments in the area, requiring adjustments at the workplace that are merely technical in nature. |
| --- | --- |

(8)

In preparing the current update of Annexes I, III V and VI to Directive 2000/54/EC, consideration was given to the need to maintain the existing levels of protection for workers who are or who are potentially exposed to biological agents through their work, and to ensure that the amendments only take into account scientific developments in the area, requiring adjustments at the workplace that are merely technical in nature.

| (9) | The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational health and safety legislation effective and fit-for-purpose. |
| --- | --- |

(9)

The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational health and safety legislation effective and fit-for-purpose.

| (10) | In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (6), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Directive 2000/54/EC should be amended to enhance its relevance and effectiveness. |
| --- | --- |

(10)

In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (6), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Directive 2000/54/EC should be amended to enhance its relevance and effectiveness.

| (11) | In a subsequent ‘Opinion on technical updates to the annexes of the Biological Agents Directive (2000/54/EC)’ (7), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that specific updates should be made to Annex I, III, V and VI, reflecting the latest technological and scientific developments in the field. |
| --- | --- |

(11)

In a subsequent ‘Opinion on technical updates to the annexes of the Biological Agents Directive (2000/54/EC)’ (7), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that specific updates should be made to Annex I, III, V and VI, reflecting the latest technological and scientific developments in the field.

| (12) | In preparing the current update of Annexes I, III, V and VI to Directive 2000/54/EC, the Commission was assisted by experts representing Member States, who provided technical and scientific support. |
| --- | --- |

(12)

In preparing the current update of Annexes I, III, V and VI to Directive 2000/54/EC, the Commission was assisted by experts representing Member States, who provided technical and scientific support.

| (13) | In accordance with the Joint Political Declaration on explanatory documents (8), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. |
| --- | --- |

(13)

In accordance with the Joint Political Declaration on explanatory documents (8), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

| (14) | The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 17 of Council Directive 89/391/EEC (9), |
| --- | --- |

(14)

The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 17 of Council Directive 89/391/EEC (9),

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes I, III, V and VI to Directive 2000/54/EC are replaced by the text in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 24 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 262, 17.10.2000, p. 21.

1

(2)  European Pillar of Social Rights, November 2017, https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en

2

(3)  SWD(2017) 10 final.

3

(4)  COM(2017) 12.

4

(5)  Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (OJ L 125, 21.5.2009, p. 75).

5

(6)  Advisory Committee for Safety and Health at Work Doc. 1718/2017.

6

(7)  Advisory Committee for Safety and Health at Work Doc. 434/18.

7

(8)  
  OJ C 369, 17.12.2011, p. 14.

8

(9)  Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).

9

---

ANNEX

(1)

‘ANNEX I

INDICATIVE LIST OF ACTIVITIES

(Article 4(2))

Preliminary note

Where the result of the risk assessment, carried out in accordance with Article 3 and Article 4(2) of this Directive, shows an unintentional exposure to biological agents, there may be other work activities, not included in this Annex, which should be considered.

| 1. | Work in food production plants. |
| --- | --- |

1.

Work in food production plants.

| 2. | Work in agriculture. |
| --- | --- |

2.

Work in agriculture.

| 3. | Work activities where there is contact with animals and/or products of animal origin. |
| --- | --- |

3.

Work activities where there is contact with animals and/or products of animal origin.

| 4. | Work in healthcare, including isolation and post-mortem units. |
| --- | --- |

4.

Work in healthcare, including isolation and post-mortem units.

| 5. | Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories. |
| --- | --- |

5.

Work in clinical, veterinary and diagnostic laboratories, excluding diagnostic microbiological laboratories.

| 6. | Work in refuse disposal plants. |
| --- | --- |

6.

Work in refuse disposal plants.

| 7. | Work in sewage purification installations. |
| --- | --- |

7.

Work in sewage purification installations.

(2)

‘ANNEX III

COMMUNITY CLASSIFICATION

Article 2, second paragraph, and Article 18

INTRODUCTORY NOTES

| 1. | In line with the scope of the Directive, only agents which are known to infect humans are to be included in the classified list.
  Where appropriate, indicators are given of the toxic and allergic potential of these agents.
  Animal and plant pathogens which are known not to affect man are excluded.
  In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms. |
| --- | --- |

1.

Where appropriate, indicators are given of the toxic and allergic potential of these agents.

Animal and plant pathogens which are known not to affect man are excluded.

In drawing up this list of classified biological agents consideration has not been given to genetically modified micro-organisms.

| 2. | The list of classified agents is based on the effect of those agents on healthy workers.
  No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.
  Additional risk to such workers should be considered as part of the risk assessment required by the Directive.
  In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive. |
| --- | --- |

2.

No specific account is taken of particular effects on those whose susceptibility may be affected for one or other reason such as pre-existing disease, medication, compromised immunity, pregnancy or breast feeding.

Additional risk to such workers should be considered as part of the risk assessment required by the Directive.

In certain industrial processes, certain laboratory work or certain work with animals involving actual or potential exposure to biological agents of groups 3 or 4, any technical precautions taken must comply with Article 16 of the Directive.

| 3. | Biological agents which have not been classified for inclusion in groups 2 to 4 of the list are not implicitly classified in group 1.
  For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.
  When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded. |
| --- | --- |

3.

For genera where more than one species is known to be pathogenic to man, the list will include those species which are known to be the most frequently responsible for diseases, together with a more general reference to the fact that other species of the same genus may affect health.

When a whole genus is mentioned in the classified list of biological agents, it is implicit that the species and strains known to be non-pathogenic are excluded.

| 4. | Where a strain is attenuated or has lost known virulence genes, then the containment required by the classification of its parent strain need not necessarily apply, subject to assessment appropriate for risk in the workplace.
  This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes. |
| --- | --- |

4.

This is the case, for example, when such a strain is to be used as a product or part of a product for prophylactic or therapeutic purposes.

| 5. | The nomenclature of classified agents used to establish this list reflects and is in conformity with the latest international agreements of the taxonomy and nomenclature of agents at the time the list was prepared. |
| --- | --- |

5.

| 6. | The list of classified biological agents reflects the state of knowledge at the time that it was devised.
  It will be updated as soon as it no longer reflects the latest state of knowledge. |
| --- | --- |

6.

It will be updated as soon as it no longer reflects the latest state of knowledge.

| 7. | Member States are to ensure that all viruses which have already been isolated in humans and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
| --- | --- |

7.

| 8. | Certain biological agents classified in group 3 which are indicated in the appended list by two asterisks (**), may present a limited risk of infection for workers because they are not normally infectious by the airborne route.
  Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with. |
| --- | --- |

8.

Member States shall assess the containment measures to be applied to such agents, taking account of the nature of specific activities in question and of the quantity of the agent involved, with a view to determining whether, in particular circumstances, some of these measures may be dispensed with.

| 9. | The requirements as to containment consequent on the classification of parasites apply only to stages in the life cycle of the parasite in which it is liable to be infectious to humans at the workplace. |
| --- | --- |

9.

| 10. | This list also gives a separate indication in cases where the biological agents are likely to cause allergic or toxic reactions, where an effective vaccine is available, or where it is advisable to keep a list of exposed workers for more than 10 years.
  These indications are shown by the following letters:






  A: | Possible allergic effects |
| --- | --- | --- |

10.

These indications are shown by the following letters:

A:

Possible allergic effects

| D: | List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure |
| --- | --- |

D:

List of workers exposed to this biological agent to be kept for more than 10 years after the end of last known exposure

| T: | Toxin production |
| --- | --- |

T:

Toxin production

| V: | Effective vaccine available and registered within the EU |
| --- | --- |

V:

Effective vaccine available and registered within the EU

The application of preventive vaccination should take account of the code of practice given in Annex VII.

BACTERIA

and similar organisms

NB: For biological agents appearing on this list, the entry of the whole genus with the addition of “spp.” refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.

| Biological agent | Classification | Notes |
| --- | --- | --- |
| Actinomadura madurae | W | |
| Actinomadura pelletieri | 2 | |
| Actinomyces gerencseriae | 2 | |
| Actinomyces israelii | 2 | |
| Actinomyces spp. | 2 | |
| Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans) | 2 | |
| Anaplasma spp. | 2 | |
| Arcanobacterium haemolyticum (Corynebacterium haenolyticum) | 2 | |
| Arcobacter butzleri | 2 | |
| Bacillus anthracis | 3 | T |
| Bacteroides fragilis | 2 | |
| Bacteroides spp. | 2 | |
| Bartonella bacilliformis | 2 | |
| Bartonella quintana (Rochalimaea quintana) | 2 | |
| Bartonella (Rochalimaea) spp. | 2 | |
| Bordetella bronchiseptica | 2 | |
| Bordetella parapertussis | 2 | |
| Bordetella pertussis | 2 | T, V |
| Bordetella spp. | 2 | |
| Borrelia burgdorferi | 2 | |
| Borrelia duttonii | 2 | |
| Borrelia recurrentis | 2 | |
| Borrelia spp. | 2 | |
| Brachyspira spp. | 2 | |
| Brucella abortus | 3 | |
| Brucella canis | 3 | |
| Brucella inopinata | 3 | |
| Brucella melitensis | 3 | |
| Brucella suis | 3 | |
| Burkholderia cepacia | 2 | |
| Burkholderia mallei (Pseudomonas mallei) | 3 | |
| Burkholderia pseudomallei (Pseudomonas pseudomallei) | 3 | D |
| Campylobacter fetus subsp. fetus | 2 | |
| Campylobacter fetus subsp. venerealis | 2 | |
| Campylobacter jejuni subsp. doylei | 2 | |
| Campylobacter jejuni subsp. jejuni | 2 | |
| Campylobacter spp. | 2 | |
| Cardiobacterium hominis | 2 | |
| Cardiobacterium valvarum | 2 | |
| Chlamydia abortus (Chlamydophila abortus) | 2 | |
| Chlamydia caviae (Chlamydophila caviae) | 2 | |
| Chlamydia felis (Chlamydophila felis) | 2 | |
| Chlamydia pneumoniae (Chlamydophila pneumoniae) | 2 | |
| Chlamydia psittaci (Chlamydophila psittaci) (avian strains) | 3 | |
| Chlamydia psittaci (Chlamydophila psittaci) (other strains) | 2 | |
| Chlamydia trachomatis (Chlamydophila trachomatis) | 2 | |
| Clostridium botulinum | 2 | T |
| Clostridium difficile | 2 | T |
| Clostridium perfringens | 2 | T |
| Clostridium tetani | 2 | T, V |
| Clostridium spp. | 2 | |
| Corynebacterium diphtheriae | 2 | T, V |
| Corynebacterium minutissimum | 2 | |
| Corynebacterium pseudotuberculosis | 2 | T |
| Corynebacterium ulcerans | 2 | T |
| Corynebacterium spp. | 2 | |
| Coxiella burnetii | 3 | |
| Edwardsiella tarda | 2 | |
| Ehrlichia spp. | 2 | |
| Eikenella corrodens | 2 | |
| Elizabethkingia meningoseptica (Flavobacterium meningosepticum) | 2 | |
| Enterobacter aerogenes (Klebsiella mobilis) | 2 | |
| Enterobacter cloacae subsp. cloacae (Enterobacter cloacae) | 2 | |
| Enterobacter spp. | 2 | |
| Enterococcus spp. | 2 | |
| Erysipelothrix rhusiopathiae | 2 | |
| Escherichia coli (with the exception of non-pathogenic strains) | 2 | |
| Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103) | 3 (*1) | T |
| Fluoribacter bozemanae (Legionella) | 2 | |
| Francisella hispaniensis | 2 | |
| Francisella tularensis subsp. holarctica | 2 | |
| Francisella tularensis subsp. mediasiatica | 2 | |
| Francisella tularensis subsp. novicida | 2 | |
| Francisella tularensis subsp. tularensis | 3 | |
| Fusobacterium necrophorum subsp. funduliforme | 2 | |
| Fusobacterium necrophorum subsp. necrophorum | 2 | |
| Gardnerella vaginalis | 2 | |
| Haemophilus ducreyi | 2 | |
| Haemophilus influenzae | 2 | V |
| Haemophilus spp. | 2 | |
| Helicobacter pylori | 2 | |
| Helicobacter spp. | 2 | |
| Klebsiella oxytoca | 2 | |
| Klebsiella pneumoniae subsp. ozaenae | 2 | |
| Klebsiella pneumoniae subsp. pneumoniae | 2 | |
| Klebsiella pneumoniae subsp. rhinoscleromatis | 2 | |
| Klebsiella spp. | 2 | |
| Legionella pneumophila subsp. fraseri | 2 | |
| Legionella pneumophila subsp. pascullei | 2 | |
| Legionella pneumophila subsp. pneumophila | 2 | |
| Legionella spp. | 2 | |
| Leptospira interrogans (all serovars) | 2 | |
| Leptospira interrogans spp. | 2 | |
| Listeria monocytogenes | 2 | |
| Listeria ivanovii subsp. ivanovii | 2 | |
| Listeria invanovii subsp. londoniensis | 2 | |
| Morganella morganii subsp. morganii (Proteus morganii) | 2 | |
| Morganella morganii subsp. sibonii | 2 | |
| Mycobacterium abscessus subsp. abscessus | 2 | |
| Mycobacterium africanum | 3 | V |
| Mycobacterium avium subsp. avium (Mycobacterium avium) | 2 | |
| Mycobacterium avium subsp. paratuberculosis (Mycobacterium paratuberculosis) | 2 | |
| Mycobacterium avium subsp. silvaticum | 2 | |
| Mycobacterium bovis | 3 | V |
| Mycobacterium caprae (Mycobacterium tuberculosis subsp. caprae) | 3 | |
| Mycobacterium chelonae | 2 | |
| Mycobacterium chimaera | 2 | |
| Mycobacterium fortuitum | 2 | |
| Mycobacterium intracellulare | 2 | |
| Mycobacterium kansasii | 2 | |
| Mycobacterium leprae | 3 | |
| Mycobacterium malmoense | 2 | |
| Mycobacterium marinum | 2 | |
| Mycobacterium microti | 3 (*1) | |
| Mycobacterium pinnipedii | 3 | |
| Mycobacterium scrofulaceum | 2 | |
| Mycobacterium simiae | 2 | |
| Mycobacterium szulgai | 2 | |
| Mycobacterium tuberculosis | 3 | V |
| Mycobacterium ulcerans | 3 (*1) | |
| Mycobacterium xenopi | 2 | |
| Mycoplasma hominis | 2 | |
| Mycoplasma pneumoniae | 2 | |
| Mycoplasma spp. | 2 | |
| Neisseria gonorrhoeae | 2 | |
| Neisseria meningitidis | 2 | V |
| Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu) | 2 | |
| Nocardia asteroides | 2 | |
| Nocardia brasiliensis | 2 | |
| Nocardia farcinica | 2 | |
| Nocardia nova | 2 | |
| Nocardia otitidiscaviarum | 2 | |
| Nocardia spp. | 2 | |
| Orientia tsutsugamushi (Rickettsia tsutsugamushi) | 3 | |
| Pasteurella multocida subsp. gallicida (Pasteurella gallicida) | 2 | |
| Pasteurella multocida subsp. multocida | 2 | |
| Pasteurella multocida subsp. septica | 2 | |
| Pasteurella spp. | 2 | |
| Peptostreptococcus anaerobius | 2 | |
| Plesiomonas shigelloides | 2 | |
| Porphyromonas spp. | 2 | |
| Prevotella spp. | 2 | |
| Proteus mirabilis | 2 | |
| Proteus penneri | 2 | |
| Proteus vulgaris | 2 | |
| Providencia alcalifaciens (Proteus inconstans) | 2 | |
| Providencia rettgeri (Proteus rettgeri) | 2 | |
| Providencia spp. | 2 | |
| Pseudomonas aeruginosa | 2 | T |
| Rhodococcus hoagii (Corynebacterium equii) | 2 | |
| Rickettsia africae | 3 | |
| Rickettsia akari | 3 (*1) | |
| Rickettsia australis | 3 | |
| Rickettsia canadensis | 2 | |
| Rickettsia conorii | 3 | |
| Rickettsia heilongjiangensis | 3 (*1) | |
| Rickettsia japonica | 3 | |
| Rickettsia montanensis | 2 | |
| Rickettsia typhi | 3 | |
| Rickettsia prowazekii | 3 | |
| Rickettsia rickettsii | 3 | |
| Rickettsia sibirica | 3 | |
| Rickettsia spp. | 2 | |
| Salmonella enterica (choleraesuis) subsp. arizonae | 2 | |
| Salmonella Enteritidis | 2 | |
| Salmonella Paratyphi A, B, C | 2 | V |
| Salmonella Typhi | 3 (*1) | V |
| Salmonella Typhimurium | 2 | |
| Salmonella (other serovars) | 2 | |
| Shigella boydii | 2 | |
| Shigella dysenteriae (Type 1) | 3 (*1) | T |
| Shigella dysenteriae, other than Type 1 | 2 | |
| Shigella flexneri | 2 | |
| Shigella sonnei | 2 | |
| Staphylococcus aureus | 2 | T |
| Streptobacillus moniliformis | 2 | |
| Streptococcus agalactiae | 2 | |
| Streptococcus dysgalactiae subsp. equisimilis | 2 | |
| Streptococcus pneumoniae | 2 | T, V |
| Streptococcus pyogenes | 2 | T |
| Streptococcus suis | 2 | |
| Streptococcus spp. | 2 | |
| Treponema carateum | 2 | |
| Treponema pallidum | 2 | |
| Treponema pertenue | 2 | |
| Treponema spp. | 2 | |
| Trueperella pyogenes | 2 | |
| Ureaplasma parvum | 2 | |
| Ureaplasma urealyticum | 2 | |
| Vibrio cholerae (including El Tor) | 2 | T, V |
| Vibrio parahaemolyticus (Benecka parahaemolytica) | 2 | |
| Vibrio spp. | 2 | |
| Yersinia enterocolitica subsp. enterolitica | 2 | |
| Yersinia enterocolitica subsp. palearctica | 2 | |
| Yersinia pestis | 3 | |
| Yersinia pseudotuberculosis | 2 | |
| Yersinia spp. | 2 | |

Biological agent

Classification

Notes

Actinomadura madurae

W

Actinomadura pelletieri

2

Actinomyces gerencseriae

2

Actinomyces israelii

2

Actinomyces spp.

2

Aggregatibacter actinomycetemcomitans (Actinobacillus actinomycetemcomitans)

2

Anaplasma spp.

2

Arcanobacterium haemolyticum (Corynebacterium haenolyticum)

2

Arcobacter butzleri

2

Bacillus anthracis

3

T

Bacteroides fragilis

2

Bacteroides spp.

2

Bartonella bacilliformis

2

Bartonella quintana (Rochalimaea quintana)

2

Bartonella (Rochalimaea) spp.

2

Bordetella bronchiseptica

2

Bordetella parapertussis

2

Bordetella pertussis

2

T, V

Bordetella spp.

2

Borrelia burgdorferi

2

Borrelia duttonii

2

Borrelia recurrentis

2

Borrelia spp.

2

Brachyspira spp.

2

Brucella abortus

3

Brucella canis

3

Brucella inopinata

3

Brucella melitensis

3

Brucella suis

3

Burkholderia cepacia

2

Burkholderia mallei (Pseudomonas mallei)

3

Burkholderia pseudomallei (Pseudomonas pseudomallei)

3

D

Campylobacter fetus subsp. fetus

2

Campylobacter fetus subsp. venerealis

2

Campylobacter jejuni subsp. doylei

2

Campylobacter jejuni subsp. jejuni

2

Campylobacter spp.

2

Cardiobacterium hominis

2

Cardiobacterium valvarum

2

Chlamydia abortus (Chlamydophila abortus)

2

Chlamydia caviae (Chlamydophila caviae)

2

Chlamydia felis (Chlamydophila felis)

2

Chlamydia pneumoniae (Chlamydophila pneumoniae)

2

Chlamydia psittaci (Chlamydophila psittaci) (avian strains)

3

Chlamydia psittaci (Chlamydophila psittaci) (other strains)

2

Chlamydia trachomatis (Chlamydophila trachomatis)

2

Clostridium botulinum

2

T

Clostridium difficile

2

T

Clostridium perfringens

2

T

Clostridium tetani

2

T, V

Clostridium spp.

2

Corynebacterium diphtheriae

2

T, V

Corynebacterium minutissimum

2

Corynebacterium pseudotuberculosis

2

T

Corynebacterium ulcerans

2

T

Corynebacterium spp.

2

Coxiella burnetii

3

Edwardsiella tarda

2

Ehrlichia spp.

2

Eikenella corrodens

2

Elizabethkingia meningoseptica (Flavobacterium meningosepticum)

2

Enterobacter aerogenes (Klebsiella mobilis)

2

Enterobacter cloacae subsp. cloacae (Enterobacter cloacae)

2

Enterobacter spp.

2

Enterococcus spp.

2

Erysipelothrix rhusiopathiae

2

Escherichia coli (with the exception of non-pathogenic strains)

2

Escherichia coli, verocytotoxigenic strains (e.g. O157:H7 or O103)

3 (*1)

T

Fluoribacter bozemanae (Legionella)

2

Francisella hispaniensis

2

Francisella tularensis subsp. holarctica

2

Francisella tularensis subsp. mediasiatica

2

Francisella tularensis subsp. novicida

2

Francisella tularensis subsp. tularensis

3

Fusobacterium necrophorum subsp. funduliforme

2

Fusobacterium necrophorum subsp. necrophorum

2

Gardnerella vaginalis

2

Haemophilus ducreyi

2

Haemophilus influenzae

2

V

Haemophilus spp.

2

Helicobacter pylori

2

Helicobacter spp.

2

Klebsiella oxytoca

2

Klebsiella pneumoniae subsp. ozaenae

2

Klebsiella pneumoniae subsp. pneumoniae

2

Klebsiella pneumoniae subsp. rhinoscleromatis

2

Klebsiella spp.

2

Legionella pneumophila subsp. fraseri

2

Legionella pneumophila subsp. pascullei

2

Legionella pneumophila subsp. pneumophila

2

Legionella spp.

2

Leptospira interrogans (all serovars)

2

Leptospira interrogans spp.

2

Listeria monocytogenes

2

Listeria ivanovii subsp. ivanovii

2

Listeria invanovii subsp. londoniensis

2

Morganella morganii subsp. morganii (Proteus morganii)

2

Morganella morganii subsp. sibonii

2

Mycobacterium abscessus subsp. abscessus

2

Mycobacterium africanum

3

V

Mycobacterium avium subsp. avium (Mycobacterium avium)

2

Mycobacterium avium subsp. paratuberculosis (Mycobacterium paratuberculosis)

2

Mycobacterium avium subsp. silvaticum

2

Mycobacterium bovis

3

V

Mycobacterium caprae (Mycobacterium tuberculosis subsp. caprae)

3

Mycobacterium chelonae

2

Mycobacterium chimaera

2

Mycobacterium fortuitum

2

Mycobacterium intracellulare

2

Mycobacterium kansasii

2

Mycobacterium leprae

3

Mycobacterium malmoense

2

Mycobacterium marinum

2

Mycobacterium microti

3 (*1)

Mycobacterium pinnipedii

3

Mycobacterium scrofulaceum

2

Mycobacterium simiae

2

Mycobacterium szulgai

2

Mycobacterium tuberculosis

3

V

Mycobacterium ulcerans

3 (*1)

Mycobacterium xenopi

2

Mycoplasma hominis

2

Mycoplasma pneumoniae

2

Mycoplasma spp.

2

Neisseria gonorrhoeae

2

Neisseria meningitidis

2

V

Neorickettsia sennetsu (Rickettsia sennetsu, Ehrlichia sennetsu)

2

Nocardia asteroides

2

Nocardia brasiliensis

2

Nocardia farcinica

2

Nocardia nova

2

Nocardia otitidiscaviarum

2

Nocardia spp.

2

Orientia tsutsugamushi (Rickettsia tsutsugamushi)

3

Pasteurella multocida subsp. gallicida (Pasteurella gallicida)

2

Pasteurella multocida subsp. multocida

2

Pasteurella multocida subsp. septica

2

Pasteurella spp.

2

Peptostreptococcus anaerobius

2

Plesiomonas shigelloides

2

Porphyromonas spp.

2

Prevotella spp.

2

Proteus mirabilis

2

Proteus penneri

2

Proteus vulgaris

2

Providencia alcalifaciens (Proteus inconstans)

2

Providencia rettgeri (Proteus rettgeri)

2

Providencia spp.

2

Pseudomonas aeruginosa

2

T

Rhodococcus hoagii (Corynebacterium equii)

2

Rickettsia africae

3

Rickettsia akari

3 (*1)

Rickettsia australis

3

Rickettsia canadensis

2

Rickettsia conorii

3

Rickettsia heilongjiangensis

3 (*1)

Rickettsia japonica

3

Rickettsia montanensis

2

Rickettsia typhi

3

Rickettsia prowazekii

3

Rickettsia rickettsii

3

Rickettsia sibirica

3

Rickettsia spp.

2

Salmonella enterica (choleraesuis) subsp. arizonae

2

Salmonella Enteritidis

2

Salmonella Paratyphi A, B, C

2

V

Salmonella Typhi

3 (*1)

V

Salmonella Typhimurium

2

Salmonella (other serovars)

2

Shigella boydii

2

Shigella dysenteriae (Type 1)

3 (*1)

T

Shigella dysenteriae, other than Type 1

2

Shigella flexneri

2

Shigella sonnei

2

Staphylococcus aureus

2

T

Streptobacillus moniliformis

2

Streptococcus agalactiae

2

Streptococcus dysgalactiae subsp. equisimilis

2

Streptococcus pneumoniae

2

T, V

Streptococcus pyogenes

2

T

Streptococcus suis

2

Streptococcus spp.

2

Treponema carateum

2

Treponema pallidum

2

Treponema pertenue

2

Treponema spp.

2

Trueperella pyogenes

2

Ureaplasma parvum

2

Ureaplasma urealyticum

2

Vibrio cholerae (including El Tor)

2

T, V

Vibrio parahaemolyticus (Benecka parahaemolytica)

2

Vibrio spp.

2

Yersinia enterocolitica subsp. enterolitica

2

Yersinia enterocolitica subsp. palearctica

2

Yersinia pestis

3

Yersinia pseudotuberculosis

2

Yersinia spp.

2

VIRUSES (*)

(*) See paragraph 7 of the introductory notes.

NB: Viruses have been listed according to their order (O), family (F) and genus (G).

| Biological agent
  (virus species or indicated taxonomy order) | Classification | Notes |
| --- | --- | --- |
| Bunyavirales (O) | | |
| Hantaviridae (F) | | |
| Orthohantavirus (G) | | |
| Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS]) | 3 | |
| Bayou orthohantavirus | 3 | |
| Black Creek Canal orthohantavirus | 3 | |
| Cano Delgadito orthohantavirus | 3 | |
| Choclo orthohantavirus | 3 | |
| Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS]) | 3 | |
| El Moro Canyon orthohantavirus | 3 | |
| Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS]) | 3 | |
| Laguna Negra orthohantavirus | 3 | |
| Prospect Hill orthohantavirus | 2 | |
| Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE]) | 2 | |
| Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS]) | 3 | |
| Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS]) | 3 | |
| Other hantaviruses known to be pathogenic | 2 | |
| Nairoviridae (F) | | |
| Orthonairovirus (G) | | |
| Crimean-Congo haemorrhagic fever orthonairovirus | 4 | |
| Dugbe orthonairovirus | 2 | |
| Hazara orthonairovirus | 2 | |
| Nairobi sheep disease orthonairovirus | 2 | |
| Other nairoviruses known to be pathogenic | 2 | |
| Peribunyaviridae (F) | | |
| Orthobunyavirus (G) | | |
| Bunyamwera orthobunyavirus (Germiston virus) | 2 | |
| California encephalitis orthobunyavirus | 2 | |
| Oropouche orthobunyavirus | 3 | |
| Other orthobunyaviruses known to be pathogenic | 2 | |
| Phenuiviridae (F) | | |
| Phlebovirus (G) | | |
| Bhanja phlebovirus | 2 | |
| Punta Toro phlebovirus | 2 | |
| Rift Valley fever phlebovirus | 3 | |
| Sandfly fever Naples phlebovirus (Toscana Virus) | 2 | |
| SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus) | 3 | |
| Other phleboviruses known to be pathogenic | 2 | |
| Herpesvirales (O) | | |
| Herpesviridae (F) | | |
| Cytomegalovirus (G) | | |
| Human betaherpesvirus 5 (Cytomegalovirus) | 2 | |
| Lymphocryptovirus (G) | | |
| Human gammaherpesvirus 4 (Epstein-Barr virus) | 2 | |
| Rhadinoovirus (G) | | |
| Human gammaherpesvirus 8 | 2 | D |
| Roseolovirus (G) | | |
| Human betaherpesvirus 6A (Human B-lymphotropic virus) | 2 | |
| Human betaherpesvirus 6B | 2 | |
| Human betaherpesvirus 7 | 2 | |
| Simplexvirus (G) | | |
| Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus) | 3 | |
| Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1) | 2 | |
| Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2) | 2 | |
| Varicellovirus (G) | | |
| Human alphaherpesvirus 3 (Herpesvirus varicella-zoster) | 2 | V |
| Mononegavirales (O) | | |
| Filoviridae (F) | | |
| Ebolavirus (G) | 4 | |
| Marburgvirus (G) | | |
| Marburg marburgvirus | 4 | |
| Paramyxoviridae (F) | | |
| Avulavirus (G) | | |
| Newcastle disease virus | 2 | |
| Henipavirus (G) | | |
| Hendra henipavirus | 4 | |
| Nipah henipavirus | 4 | |
| Morbillivirus (G) | | |
| Measles morbillivirus | 2 | V |
| Respirovirus (G) | | |
| Human respirovirus 1 (Parainfluenza virus 1) | 2 | |
| Human respirovirus 3 (Parainfluenza virus 3) | 2 | |
| Rubulavirus (G) | | |
| Mumps rubulavirus | 2 | V |
| Human rubulavirus 2 (Parainfluenza virus 2) | 2 | |
| Human rubulavirus 4 (Parainfluenza virus 4) | 2 | |
| Pneumoviridae (F) | | |
| Metapneumovirus (G) | | |
| Orthopneumovirus (G) | | |
| Human orthopneumovirus (Respiratory syncytial virus) | 2 | |
| Rhabdoviridae (F) | | |
| Lyssavirus (G) | | |
| Australian bat lyssavirus | 3 (*3) | V |
| Duvenhage lyssavirus | 3 (*3) | V |
| European bat lyssavirus 1 | 3 (*3) | V |
| European bat lyssavirus 2 | 3 (*3) | V |
| Lagos bat lyssavirus | 3 (*3) | |
| Mokola lyssavirus | 3 | |
| Rabies lyssavirus | 3 (*3) | V |
| Vesiculovirus (G) | | |
| Vesicular stomatitis virus, Alagoas vesiculovirus | 2 | |
| Vesicular stomatitis virus, Indiana vesiculovirus | 2 | |
| Vesicular stomatitis virus, New Jersey vesiculovirus | 2 | |
| Piry vesiculovirus (Piry virus) | 2 | |
| Nidovirales (O) | | |
| Coronaviridae (F) | | |
| Betacoronavirus (G) | | |
| Severe acute respiratory syndrome-related coronavirus (SARS-virus) | 3 | |
| Middle East respiratory syndrome coronavirus (MERS-virus) | 3 | |
| Other Coronaviridae known to be pathogenic | 2 | |
| Picornavirales (O) | | |
| Picornaviridae (F) | | |
| Cardiovirus (G) | | |
| Saffold virus | 2 | |
| Cosavirus (G) | | |
| Cosavirus A | 2 | |
| Enterovirus (G) | | |
| Enterovirus A | 2 | |
| Enterovirus B | 2 | |
| Enterovirus C | 2 | |
| Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus) | 2 | |
| Rhinoviruses | 2 | |
| Poliovirus, type 1 and 3 | 2 | V |
| Poliovirus, type 2  (1) | 3 | V |
| Hepatovirus (G) | | |
| Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72) | 2 | V |
| Kobuvirus (G) | | |
| Aichivirus A (Aichi virus 1) | 2 | |
| Parechovirus (G) | | |
| Parechoviruses A | 2 | |
| Parechoviruses B (Ljungan virus) | 2 | |
| Other Picornaviridae known to be pathogenic | 2 | |
| Unassigned (O) | | |
| Adenoviridae (F) | 2 | |
| Astroviridae (F) | 2 | |
| Arenaviridae (F) | | |
| Mammarenavirus (G) | | |
| Brazilian mammarenavirus | 4 | |
| Chapare mammarenavirus | 4 | |
| Flexal mammarenavirus | 3 | |
| Guanarito mammarenavirus | 4 | |
| Junín mammarenavirus | 4 | |
| Lassa mammarenavirus | 4 | |
| Lujo mammarenavirus | 4 | |
| Lymphocytic choriomeningitis mammarenavirus, neurotropic strains | 2 | |
| Lymphocytic choriomeningitis mammarenavirus (other strains) | 2 | |
| Machupo mammarenavirus | 4 | |
| Mobala mammarenavirus | 2 | |
| Mopeia mammarenavirus | 2 | |
| Tacaribe mammarenavirus | 2 | |
| Whitewater Arroyo mammarenavirus | 3 | |
| Caliciviridae (F) | | |
| Norovirus (G) | | |
| Norovirus (Norwalk virus) | 2 | |
| Other Caliciviridae known to be pathogenic | 2 | |
| Hepadnaviridae (F) | | |
| Orthohepadnavirus (G) | | |
| Hepatitis B virus | 3 (*3) | V, D |
| Hepeviridae (F) | | |
| Orthohepevirus (G) | | |
| Orthohepevirus A (Hepatitis E virus) | 2 | |
| Flaviviridae (F) | | |
| Flavivirus (G) | | |
| Dengue virus | 3 | |
| Japanese encephalitis virus | 3 | V |
| Kyasanur Forest disease virus | 3 | V |
| Louping ill virus | 3 (*3) | |
| Murray Valley encephalitis virus (Australia encephalitis virus) | 3 | |
| Omsk haemorrhagic fever virus | 3 | |
| Powassan virus | 3 | |
| Rocio virus | 3 | |
| St. Louis encephalitis virus | 3 | |
| Tick-borne encephalitis virus | | |
| Absettarov virus | 3 | |
| Hanzalova virus | 3 | |
| Hypr virus | 3 | |
| Kumlinge virus | 3 | |
| Negishi virus | 3 | |
| Russian spring-summer encephalitis (1) | 3 | V |
| Tick-borne encephalitis virus Central European subtype | 3 (*3) | V |
| Tick-borne encephalitis virus Far Eastern Subtype | 3 | |
| Tick-borne encephalitis virus Siberian subtype | 3 | V |
| Wesselsbron virus | 3 (*3) | |
| West Nile fever virus | 3 | |
| Yellow fever virus | 3 | V |
| Zika virus | 2 | |
| Other flaviviruses known to be pathogenic | 2 | |
| Hepacivirus (G) | | |
| Hepacivirus C (Hepatitis C virus) | 3 (*3) | D |
| Orthomyxoviridae (F) | | |
| Gammainfluenzavirus (G) | | |
| Influenza C virus | 2 | V (3) |
| Influenzavirus A (G) | | |
| Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N1 | 3 | |
| Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N9 | 3 | |
| Influenza A virus | 2 | V (3) |
| Influenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918) | 3 | |
| Influenza A virus A/Singapore/1/57 (H2N2) | 3 | |
| Low Pathogenic Avian Influenza Virus (LPAI) H7N9 | 3 | |
| Influenzavirus B (G) | | |
| Influenza B virus | 2 | V (3) |
| Thogoto virus (G) | | |
| Dhori virus (Tick-borne orthomyxoviridae: Dhori) | 2 | |
| Thogoto virus (Tick-borne orthomyxoviridae: Thogoto) | 2 | |
| Papillomaviridae (F) | 2 | D (4) |
| Parvoviridae (F) | | |
| Erythroparvovirus (G) | | |
| Primate erythroparvovirus 1 (Human parvovirus, B 19 virus) | 2 | |
| Polyomaviridae (F) | | |
| Betapolyomavirus (G) | | |
| Human polyomavirus 1 (BK virus) | 2 | D (4) |
| Human polyomavirus 2 (JC virus) | 2 | D (4) |
| Poxviridae (F) | | |
| Molluscipoxvirus (G) | | |
| Molluscum contagiosum virus | 2 | |
| Orthopoxvirus (G) | | |
| Cowpox virus | 2 | |
| Monkeypox virus | 3 | V |
| Vaccinia virus (incl. Buffalopox virus  (5), Elephantpox virus  (6), Rabbitpox virus  (7)) | 2 | |
| Variola (major and minor) virus | 4 | V |
| Parapoxvirus (G) | | |
| Orf virus | 2 | |
| Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis) | 2 | |
| Yatapoxvirus (G) | | |
| Tanapox virus | 2 | |
| Yaba monkey tumor virus | 2 | |
| Reoviridae (F) | | |
| Seadornavirus (G) | | |
| Banna virus | 2 | |
| Coltivirus (G) | 2 | |
| Rotaviruses (G) | 2 | |
| Orbivirus (G) | 2 | |
| Retroviridae (F) | | |
| Deltaretrovirus (G) | | |
| Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1) | 3 (*3) | D |
| Primate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2) | 3 (*3) | D |
| Lentivirus (G) | | |
| Human immunodeficiency virus 1 | 3 (*3) | D |
| Human immunodeficiency virus 2 | 3 (*3) | D |
| Simian Immunodeficiency Virus (SIV) (8) | 2 | |
| Togaviridae (F) | | |
| Alphavirus (G) | | |
| Cabassouvirus | 3 | |
| Eastern equine encephalomyelitis virus | 3 | V |
| Bebaru virus | 2 | |
| Chikungunya virus | 3 (*3) | |
| Everglades virus | 3 (*3) | |
| Mayaro virus | 3 | |
| Mucambo virus | 3 (*3) | |
| Ndumu virus | 3 (*3) | |
| O’nyong-nyong virus | 2 | |
| Ross River virus | 2 | |
| Semliki Forest virus | 2 | |
| Sindbis virus | 2 | |
| Tonate virus | 3 (*3) | |
| Venezuelan equine encephalomyelitis virus | 3 | V |
| Western equine encephalomyelitis virus | 3 | V |
| Other alphaviruses known to be pathogenic | 2 | |
| Rubivirus (G) | | |
| Rubella virus | 2 | V |
| Unassigned (F) | | |
| Deltavirus (G) | | |
| Hepatitis delta virus (2) | 2 | V, D |

Biological agent

(virus species or indicated taxonomy order)

Classification

Notes

Bunyavirales (O)

Hantaviridae (F)

Orthohantavirus (G)

Andes orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])

3

Bayou orthohantavirus

3

Black Creek Canal orthohantavirus

3

Cano Delgadito orthohantavirus

3

Choclo orthohantavirus

3

Dobrava-Belgrade orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])

3

El Moro Canyon orthohantavirus

3

Hantaan orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])

3

Laguna Negra orthohantavirus

3

Prospect Hill orthohantavirus

2

Puumala orthohantavirus (Hantavirus species causing Nephropathia Epidemica [NE])

2

Seoul orthohantavirus (Hantavirus species causing Haemorrhagic Fever with Renal Syndrome [HFRS])

3

Sin Nombre orthohantavirus (Hantavirus species causing Hantavirus Pulmonary Syndrome [HPS])

3

Other hantaviruses known to be pathogenic

2

Nairoviridae (F)

Orthonairovirus (G)

Crimean-Congo haemorrhagic fever orthonairovirus

4

Dugbe orthonairovirus

2

Hazara orthonairovirus

2

Nairobi sheep disease orthonairovirus

2

Other nairoviruses known to be pathogenic

2

Peribunyaviridae (F)

Orthobunyavirus (G)

Bunyamwera orthobunyavirus (Germiston virus)

2

California encephalitis orthobunyavirus

2

Oropouche orthobunyavirus

3

Other orthobunyaviruses known to be pathogenic

2

Phenuiviridae (F)

Phlebovirus (G)

Bhanja phlebovirus

2

Punta Toro phlebovirus

2

Rift Valley fever phlebovirus

3

Sandfly fever Naples phlebovirus (Toscana Virus)

2

SFTS phlebovirus (Severe Fever with Thrombocytopenia Syndrome-Virus)

3

Other phleboviruses known to be pathogenic

2

Herpesvirales (O)

Herpesviridae (F)

Cytomegalovirus (G)

Human betaherpesvirus 5 (Cytomegalovirus)

2

Lymphocryptovirus (G)

Human gammaherpesvirus 4 (Epstein-Barr virus)

2

Rhadinoovirus (G)

Human gammaherpesvirus 8

2

D

Roseolovirus (G)

Human betaherpesvirus 6A (Human B-lymphotropic virus)

2

Human betaherpesvirus 6B

2

Human betaherpesvirus 7

2

Simplexvirus (G)

Macacine alphaherpesvirus 1 (Herpesvirus simiae, Herpes B virus)

3

Human alphaherpesvirus 1 (Human herpesvirus 1, Herpes simplex virus type 1)

2

Human alphaherpesvirus 2 (Human herpesvirus 2, Herpes simplex virus type 2)

2

Varicellovirus (G)

Human alphaherpesvirus 3 (Herpesvirus varicella-zoster)

2

V

Mononegavirales (O)

Filoviridae (F)

Ebolavirus (G)

4

Marburgvirus (G)

Marburg marburgvirus

4

Paramyxoviridae (F)

Avulavirus (G)

Newcastle disease virus

2

Henipavirus (G)

Hendra henipavirus

4

Nipah henipavirus

4

Morbillivirus (G)

Measles morbillivirus

2

V

Respirovirus (G)

Human respirovirus 1 (Parainfluenza virus 1)

2

Human respirovirus 3 (Parainfluenza virus 3)

2

Rubulavirus (G)

Mumps rubulavirus

2

V

Human rubulavirus 2 (Parainfluenza virus 2)

2

Human rubulavirus 4 (Parainfluenza virus 4)

2

Pneumoviridae (F)

Metapneumovirus (G)

Orthopneumovirus (G)

Human orthopneumovirus (Respiratory syncytial virus)

2

Rhabdoviridae (F)

Lyssavirus (G)

Australian bat lyssavirus

3 (*3)

V

Duvenhage lyssavirus

3 (*3)

V

European bat lyssavirus 1

3 (*3)

V

European bat lyssavirus 2

3 (*3)

V

Lagos bat lyssavirus

3 (*3)

Mokola lyssavirus

3

Rabies lyssavirus

3 (*3)

V

Vesiculovirus (G)

Vesicular stomatitis virus, Alagoas vesiculovirus

2

Vesicular stomatitis virus, Indiana vesiculovirus

2

Vesicular stomatitis virus, New Jersey vesiculovirus

2

Piry vesiculovirus (Piry virus)

2

Nidovirales (O)

Coronaviridae (F)

Betacoronavirus (G)

Severe acute respiratory syndrome-related coronavirus (SARS-virus)

3

Middle East respiratory syndrome coronavirus (MERS-virus)

3

Other Coronaviridae known to be pathogenic

2

Picornavirales (O)

Picornaviridae (F)

Cardiovirus (G)

Saffold virus

2

Cosavirus (G)

Cosavirus A

2

Enterovirus (G)

Enterovirus A

2

Enterovirus B

2

Enterovirus C

2

Enterovirus D, Human Enterovirus type 70 (Acute haemorrhagic conjunctivitis virus)

2

Rhinoviruses

2

Poliovirus, type 1 and 3

2

V

Poliovirus, type 2  (1)

3

V

Hepatovirus (G)

Hepatovirus A (Hepatitis A virus, Human Enterovirus type 72)

2

V

Kobuvirus (G)

Aichivirus A (Aichi virus 1)

2

Parechovirus (G)

Parechoviruses A

2

Parechoviruses B (Ljungan virus)

2

Other Picornaviridae known to be pathogenic

2

Unassigned (O)

Adenoviridae (F)

2

Astroviridae (F)

2

Arenaviridae (F)

Mammarenavirus (G)

Brazilian mammarenavirus

4

Chapare mammarenavirus

4

Flexal mammarenavirus

3

Guanarito mammarenavirus

4

Junín mammarenavirus

4

Lassa mammarenavirus

4

Lujo mammarenavirus

4

Lymphocytic choriomeningitis mammarenavirus, neurotropic strains

2

Lymphocytic choriomeningitis mammarenavirus (other strains)

2

Machupo mammarenavirus

4

Mobala mammarenavirus

2

Mopeia mammarenavirus

2

Tacaribe mammarenavirus

2

Whitewater Arroyo mammarenavirus

3

Caliciviridae (F)

Norovirus (G)

Norovirus (Norwalk virus)

2

Other Caliciviridae known to be pathogenic

2

Hepadnaviridae (F)

Orthohepadnavirus (G)

Hepatitis B virus

3 (*3)

V, D

Hepeviridae (F)

Orthohepevirus (G)

Orthohepevirus A (Hepatitis E virus)

2

Flaviviridae (F)

Flavivirus (G)

Dengue virus

3

Japanese encephalitis virus

3

V

Kyasanur Forest disease virus

3

V

Louping ill virus

3 (*3)

Murray Valley encephalitis virus (Australia encephalitis virus)

3

Omsk haemorrhagic fever virus

3

Powassan virus

3

Rocio virus

3

St. Louis encephalitis virus

3

Tick-borne encephalitis virus

Absettarov virus

3

Hanzalova virus

3

Hypr virus

3

Kumlinge virus

3

Negishi virus

3

Russian spring-summer encephalitis (1)

3

V

Tick-borne encephalitis virus Central European subtype

3 (*3)

V

Tick-borne encephalitis virus Far Eastern Subtype

3

Tick-borne encephalitis virus Siberian subtype

3

V

Wesselsbron virus

3 (*3)

West Nile fever virus

3

Yellow fever virus

3

V

Zika virus

2

Other flaviviruses known to be pathogenic

2

Hepacivirus (G)

Hepacivirus C (Hepatitis C virus)

3 (*3)

D

Orthomyxoviridae (F)

Gammainfluenzavirus (G)

Influenza C virus

2

V (3)

Influenzavirus A (G)

Highly Pathogenic Avian Influenza Viruses HPAIV (H5), e.g. H5N1

3

Highly Pathogenic Avian Influenza Viruses HPAIV (H7), e.g. H7N7, H7N9

3

Influenza A virus

2

V (3)

Influenza A virus A/New York/1/18 (H1N1) (Spanish flu 1918)

3

Influenza A virus A/Singapore/1/57 (H2N2)

3

Low Pathogenic Avian Influenza Virus (LPAI) H7N9

3

Influenzavirus B (G)

Influenza B virus

2

V (3)

Thogoto virus (G)

Dhori virus (Tick-borne orthomyxoviridae: Dhori)

2

Thogoto virus (Tick-borne orthomyxoviridae: Thogoto)

2

Papillomaviridae (F)

2

D (4)

Parvoviridae (F)

Erythroparvovirus (G)

Primate erythroparvovirus 1 (Human parvovirus, B 19 virus)

2

Polyomaviridae (F)

Betapolyomavirus (G)

Human polyomavirus 1 (BK virus)

2

D (4)

Human polyomavirus 2 (JC virus)

2

D (4)

Poxviridae (F)

Molluscipoxvirus (G)

Molluscum contagiosum virus

2

Orthopoxvirus (G)

Cowpox virus

2

Monkeypox virus

3

V

Vaccinia virus (incl. Buffalopox virus  (5), Elephantpox virus  (6), Rabbitpox virus  (7))

2

Variola (major and minor) virus

4

V

Parapoxvirus (G)

Orf virus

2

Pseudocowpox virus (Milkers’ node virus, parapoxvirus bovis)

2

Yatapoxvirus (G)

Tanapox virus

2

Yaba monkey tumor virus

2

Reoviridae (F)

Seadornavirus (G)

Banna virus

2

Coltivirus (G)

2

Rotaviruses (G)

2

Orbivirus (G)

2

Retroviridae (F)

Deltaretrovirus (G)

Primate T-lymphotropic virus 1 (Human T-cell lymphotropic virus, type 1)

3 (*3)

D

Primate T-lymphotropic virus 2 (Human T-cell lymphotropic virus, type 2)

3 (*3)

D

Lentivirus (G)

Human immunodeficiency virus 1

3 (*3)

D

Human immunodeficiency virus 2

3 (*3)

D

Simian Immunodeficiency Virus (SIV) (8)

2

Togaviridae (F)

Alphavirus (G)

Cabassouvirus

3

Eastern equine encephalomyelitis virus

3

V

Bebaru virus

2

Chikungunya virus

3 (*3)

Everglades virus

3 (*3)

Mayaro virus

3

Mucambo virus

3 (*3)

Ndumu virus

3 (*3)

O’nyong-nyong virus

2

Ross River virus

2

Semliki Forest virus

2

Sindbis virus

2

Tonate virus

3 (*3)

Venezuelan equine encephalomyelitis virus

3

V

Western equine encephalomyelitis virus

3

V

Other alphaviruses known to be pathogenic

2

Rubivirus (G)

Rubella virus

2

V

Unassigned (F)

Deltavirus (G)

Hepatitis delta virus (2)

2

V, D

PRION DISEASE AGENTS

| Biological agent | Classification | Notes |
| --- | --- | --- |
| Agent of Creutzfeldt-Jakob disease | 3 (*4) | D (9) |
| Variant Agent of Creutzfeldt-Jakob disease | 3 (*4) | D (9) |
| Agent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs | 3 (*4) | D (9) |
| Agent of Gerstmann-Sträussler-Scheinker syndrome | 3 (*4) | D (9) |
| Agent of Kuru | 3 (*4) | D (9) |
| Agent of Scrapie | 2 | |

Biological agent

Classification

Notes

Agent of Creutzfeldt-Jakob disease

3 (*4)

D (9)

Variant Agent of Creutzfeldt-Jakob disease

3 (*4)

D (9)

Agent of Bovine Spongiform Encephalopathy (BSE) and other related animal TSEs

3 (*4)

D (9)

Agent of Gerstmann-Sträussler-Scheinker syndrome

3 (*4)

D (9)

Agent of Kuru

3 (*4)

D (9)

Agent of Scrapie

2

PARASITES

NB: For biological agents appearing on this list, the entry of the whole genus with the addition of “spp.” refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.

| Biological agent | Classification | Notes |
| --- | --- | --- |
| Acanthamoeba castellani | 2 | |
| Ancylostoma duodenale | 2 | |
| Angiostrongylus cantonensis | 2 | |
| Angiostrongylus costaricensis | 2 | |
| Anisakis simplex | 2 | A |
| Ascaris lumbricoides | 2 | A |
| Ascaris suum | 2 | A |
| Babesia divergens | 2 | |
| Babesia microti | 2 | |
| Balamuthia mandrillaris | 3 | |
| Balantidium coli | 2 | |
| Brugia malayi | 2 | |
| Brugia pahangi | 2 | |
| Brugia timori | 2 | |
| Capillaria philippinensis | 2 | |
| Capillaria spp. | 2 | |
| Clonorchis sinensis (Opisthorchis sinensis) | 2 | |
| Clonorchis viverrini (Opisthirchis viverrini) | 2 | |
| Cryptosporidium hominis | 2 | |
| Cryptosporidium parvum | 2 | |
| Cyclospora cayetanensis | 2 | |
| Dicrocoelium dentriticum | 2 | |
| Dipetalonema streptocerca | 2 | |
| Diphyllobothrium latum | 2 | |
| Dracunculus medinensis | 2 | |
| Echinococcus granulosus | 3 (*5) | |
| Echinococcus multilocularis | 3 (*5) | |
| Echinococcus oligarthrus | 3 (*5) | |
| Echinococcus vogeli | 3 (*5) | |
| Entamoeba histolytica | 2 | |
| Enterobius vermicularis | 2 | |
| Enterocytozoon bieneusi | 2 | |
| Fasciola gigantica | 2 | |
| Fasciola hepatica | 2 | |
| Fasciolopsis buski | 2 | |
| Giardia lamblia (Giardia duodenalis, Giardia intestinalis) | 2 | |
| Heterophyes spp. | 2 | |
| Hymenolepis diminuta | 2 | |
| Hymenolepis nana | 2 | |
| Leishmania aethiopica | 2 | |
| Leishmania braziliensis | 3 (*5) | |
| Leishmania donovani | 3 (*5) | |
| Leishmania guyanensis (Viannia guyanensis) | 3 (*5) | |
| Leishmania infantum (Leishmania chagasi) | 3 (*5) | |
| Leishmania major | 2 | |
| Leishmania mexicana | 2 | |
| Leishmania panamensis (Viannia panamensis) | 3 (*5) | |
| Leishmania peruviana | 2 | |
| Leishmania tropica | 2 | |
| Leishmania spp. | 2 | |
| Loa loa | 2 | |
| Mansonella ozzardi | 2 | |
| Mansonella perstans | 2 | |
| Mansonella streptocerca | 2 | |
| Metagonimus spp. | 2 | |
| Naegleria fowleri | 3 | |
| Necator americanus | 2 | |
| Onchocerca volvulus | 2 | |
| Opisthorchis felineus | 2 | |
| Opisthorchis spp. | 2 | |
| Paragonimus westermani | 2 | |
| Paragonimus spp. | 2 | |
| Plasmodium falciparum | 3 (*5) | |
| Plasmodium knowlesi | 3 (*5) | |
| Plasmodium spp. (human and simian) | 2 | |
| Sarcocystis suihominis | 2 | |
| Schistosoma haematobium | 2 | |
| Schistosoma intercalatum | 2 | |
| Schistosoma japonicum | 2 | |
| Schistosoma mansoni | 2 | |
| Schistosoma mekongi | 2 | |
| Strongyloides stercoralis | 2 | |
| Strongyloides spp. | 2 | |
| Taenia saginata | 2 | |
| Taenia solium | 3 (*5) | |
| Toxocara canis | 2 | |
| Toxocara cati | 2 | |
| Toxoplasma gondii | 2 | |
| Trichinella nativa | 2 | |
| Trichinella nelsoni | 2 | |
| Trichinella pseudospiralis | 2 | |
| Trichinella spiralis | 2 | |
| Trichomonas vaginalis | 2 | |
| Trichostrongylus orientalis | 2 | |
| Trichostrongylus spp. | 2 | |
| Trichuris trichiura | 2 | |
| Trypanosoma brucei brucei | 2 | |
| Trypanosoma brucei gambiense | 2 | |
| Trypanosoma brucei rhodesiense | 3 (*5) | |
| Trypanosoma cruzi | 3 (*5) | |
| Wuchereria bancrofti | 2 | |

Biological agent

Classification

Notes

Acanthamoeba castellani

2

Ancylostoma duodenale

2

Angiostrongylus cantonensis

2

Angiostrongylus costaricensis

2

Anisakis simplex

2

A

Ascaris lumbricoides

2

A

Ascaris suum

2

A

Babesia divergens

2

Babesia microti

2

Balamuthia mandrillaris

3

Balantidium coli

2

Brugia malayi

2

Brugia pahangi

2

Brugia timori

2

Capillaria philippinensis

2

Capillaria spp.

2

Clonorchis sinensis (Opisthorchis sinensis)

2

Clonorchis viverrini (Opisthirchis viverrini)

2

Cryptosporidium hominis

2

Cryptosporidium parvum

2

Cyclospora cayetanensis

2

Dicrocoelium dentriticum

2

Dipetalonema streptocerca

2

Diphyllobothrium latum

2

Dracunculus medinensis

2

Echinococcus granulosus

3 (*5)

Echinococcus multilocularis

3 (*5)

Echinococcus oligarthrus

3 (*5)

Echinococcus vogeli

3 (*5)

Entamoeba histolytica

2

Enterobius vermicularis

2

Enterocytozoon bieneusi

2

Fasciola gigantica

2

Fasciola hepatica

2

Fasciolopsis buski

2

Giardia lamblia (Giardia duodenalis, Giardia intestinalis)

2

Heterophyes spp.

2

Hymenolepis diminuta

2

Hymenolepis nana

2

Leishmania aethiopica

2

Leishmania braziliensis

3 (*5)

Leishmania donovani

3 (*5)

Leishmania guyanensis (Viannia guyanensis)

3 (*5)

Leishmania infantum (Leishmania chagasi)

3 (*5)

Leishmania major

2

Leishmania mexicana

2

Leishmania panamensis (Viannia panamensis)

3 (*5)

Leishmania peruviana

2

Leishmania tropica

2

Leishmania spp.

2

Loa loa

2

Mansonella ozzardi

2

Mansonella perstans

2

Mansonella streptocerca

2

Metagonimus spp.

2

Naegleria fowleri

3

Necator americanus

2

Onchocerca volvulus

2

Opisthorchis felineus

2

Opisthorchis spp.

2

Paragonimus westermani

2

Paragonimus spp.

2

Plasmodium falciparum

3 (*5)

Plasmodium knowlesi

3 (*5)

Plasmodium spp. (human and simian)

2

Sarcocystis suihominis

2

Schistosoma haematobium

2

Schistosoma intercalatum

2

Schistosoma japonicum

2

Schistosoma mansoni

2

Schistosoma mekongi

2

Strongyloides stercoralis

2

Strongyloides spp.

2

Taenia saginata

2

Taenia solium

3 (*5)

Toxocara canis

2

Toxocara cati

2

Toxoplasma gondii

2

Trichinella nativa

2

Trichinella nelsoni

2

Trichinella pseudospiralis

2

Trichinella spiralis

2

Trichomonas vaginalis

2

Trichostrongylus orientalis

2

Trichostrongylus spp.

2

Trichuris trichiura

2

Trypanosoma brucei brucei

2

Trypanosoma brucei gambiense

2

Trypanosoma brucei rhodesiense

3 (*5)

Trypanosoma cruzi

3 (*5)

Wuchereria bancrofti

2

FUNGI

NB: For biological agents appearing on this list, the entry of the whole genus with the addition of “spp.” refers to other species belonging to this genus that have not specifically been included in the list, but which are known pathogens in humans. See introductory note 3 for further details.

| Biological agent | Classification | Notes |
| --- | --- | --- |
| Aspergillus flavus | 2 | A |
| Aspergillus fumigatus | 2 | A |
| Aspergillus spp. | 2 | |
| Blastomyces dermatitidis (Ajellomyces dermatitidis) | 3 | |
| Blastomyces gilchristii | 3 | |
| Candida albicans | 2 | A |
| Candida dubliniensis | 2 | |
| Candida glabrata | 2 | |
| Candida parapsilosis | 2 | |
| Candida tropicalis | 2 | |
| Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,
  trichoides) | 3 | |
| Cladophialophora modesta | 3 | |
| Cladophialophora spp. | 2 | |
| Coccidioides immitis | 3 | A |
| Coccidioides posadasii | 3 | A |
| Cryptococcus gattii (Filobasidiella neoformans var. bacillispora) | 2 | A |
| Cryptococcus neoformans (Filobasidiella neoformans var. neoformans) | 2 | A |
| Emmonsia parva var. parva | 2 | |
| Emmonsia parva var. crescens | 2 | |
| Epidermophyton floccosum | 2 | A |
| Epidermophyton spp. | 2 | |
| Fonsecaea pedrosoi | 2 | |
| Histoplasma capsulatum | 3 | |
| Histoplasma capsulatum var. farciminosum | 3 | |
| Histoplasma duboisii | 3 | |
| Madurella grisea | 2 | |
| Madurella mycetomatis | 2 | |
| Microsporum spp. | 2 | A |
| Nannizzia spp. | 2 | |
| Neotestudina rosatii | 2 | |
| Paracoccidioides brasiliensis | 3 | A |
| Paracoccidioides lutzii | 3 | |
| Paraphyton spp. | 2 | |
| Rhinocladiella mackenziei | 3 | |
| Scedosporium apiospermum | 2 | |
| Scedosporium prolificans (inflatum) | 2 | |
| Sporothrix schenckii | 2 | |
| Talaromyces marneffei (Penicillium marneffei) | 2 | A |
| Trichophyton rubrum | 2 | A |
| Trichophyton tonsurans | 2 | A |
| Trichophyton spp. | 2 | |

Biological agent

Classification

Notes

Aspergillus flavus

2

A

Aspergillus fumigatus

2

A

Aspergillus spp.

2

Blastomyces dermatitidis (Ajellomyces dermatitidis)

3

Blastomyces gilchristii

3

Candida albicans

2

A

Candida dubliniensis

2

Candida glabrata

2

Candida parapsilosis

2

Candida tropicalis

2

Cladophialophora bantiana (Xylohypha bantiana, Cladosporium bantianum,
  trichoides)

3

Cladophialophora modesta

3

Cladophialophora spp.

2

Coccidioides immitis

3

A

Coccidioides posadasii

3

A

Cryptococcus gattii (Filobasidiella neoformans var. bacillispora)

2

A

Cryptococcus neoformans (Filobasidiella neoformans var. neoformans)

2

A

Emmonsia parva var. parva

2

Emmonsia parva var. crescens

2

Epidermophyton floccosum

2

A

Epidermophyton spp.

2

Fonsecaea pedrosoi

2

Histoplasma capsulatum

3

Histoplasma capsulatum var. farciminosum

3

Histoplasma duboisii

3

Madurella grisea

2

Madurella mycetomatis

2

Microsporum spp.

2

A

Nannizzia spp.

2

Neotestudina rosatii

2

Paracoccidioides brasiliensis

3

A

Paracoccidioides lutzii

3

Paraphyton spp.

2

Rhinocladiella mackenziei

3

Scedosporium apiospermum

2

Scedosporium prolificans (inflatum)

2

Sporothrix schenckii

2

Talaromyces marneffei (Penicillium marneffei)

2

A

Trichophyton rubrum

2

A

Trichophyton tonsurans

2

A

Trichophyton spp.

2

(3)

‘ANNEX V

INDICATIONS CONCERNING CONTAINMENT MEASURES AND CONTAINMENT LEVELS

(Articles 15(3) and 16(1)(a) and (b))

Preliminary note

The measures contained in this Annex shall be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned.

In the table, “Recommended” means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.

| A. Containment measures | B. Containment levels |
| --- | --- |
| 2 | 3 | 4 |
| Workplace |
| 1. The workplace is to be separated from any other activities in the same building | No | Recommended | Yes |
| 2. The workplace is to be sealable to permit fumigation | No | Recommended | Yes |
| Facilities |
| 3. Infected material including any animal is to be handled in a safety cabinet or isolation or other suitable containment | Where appropriate | Yes, where infection is by airborne route | Yes |
| Equipment |
| 4. Input air and extract air to the workplace are to be filtered using (HEPA (2)) or likewise | No | Yes, on extract air | Yes, on input and extract air |
| 5. The workplace is to be maintained at an air pressure negative to atmosphere | No | Recommended | Yes |
| 6. Surfaces impervious to water and easy to clean | Yes, for bench and floor | Yes, for bench, floor and other surfaces determined by risk assessment | Yes, for bench, walls, floor and ceiling |
| 7. Surfaces resistant to acids, alkalis, solvents, disinfectants | Recommended | Yes | Yes |
| System of work |
| 8. Access is to be restricted to nominated workers only | Recommended | Yes | Yes, via airlock (3) |
| 9. Efficient vector control, for example rodents and insects | Recommended | Yes | Yes |
| 10. Specified disinfection procedures | Yes | Yes | Yes |
| 11. Safe storage of a biological agent | Yes | Yes | Yes, secure storage |
| 12. Personnel should shower before leaving the contained area | No | Recommended | Recommended |
| Waste |
| 13. Validated inactivation process for the safe disposal of animal carcases | Recommended | Yes, on or off site | Yes, on site |
| Other measures |
| 14. A laboratory is to contain its own equipment | No | Recommended | Yes |
| 15. An observation window, or, alternative, is to be present, so that occupants can be seen | Recommended | Recommended | Yes |

A. Containment measures

B. Containment levels

2

3

4

Workplace

1. The workplace is to be separated from any other activities in the same building

No

Recommended

Yes

2. The workplace is to be sealable to permit fumigation

No

Recommended

Yes

Facilities

3. Infected material including any animal is to be handled in a safety cabinet or isolation or other suitable containment

Where appropriate

Yes, where infection is by airborne route

Yes

Equipment

4. Input air and extract air to the workplace are to be filtered using (HEPA (2)) or likewise

No

Yes, on extract air

Yes, on input and extract air

5. The workplace is to be maintained at an air pressure negative to atmosphere

No

Recommended

Yes

6. Surfaces impervious to water and easy to clean

Yes, for bench and floor

Yes, for bench, floor and other surfaces determined by risk assessment

Yes, for bench, walls, floor and ceiling

7. Surfaces resistant to acids, alkalis, solvents, disinfectants

Recommended

Yes

Yes

System of work

8. Access is to be restricted to nominated workers only

Recommended

Yes

Yes, via airlock (3)

9. Efficient vector control, for example rodents and insects

Recommended

Yes

Yes

10. Specified disinfection procedures

Yes

Yes

Yes

11. Safe storage of a biological agent

Yes

Yes

Yes, secure storage

12. Personnel should shower before leaving the contained area

No

Recommended

Recommended

Waste

13. Validated inactivation process for the safe disposal of animal carcases

Recommended

Yes, on or off site

Yes, on site

Other measures

14. A laboratory is to contain its own equipment

No

Recommended

Yes

15. An observation window, or, alternative, is to be present, so that occupants can be seen

Recommended

Recommended

Yes

(4)

‘ANNEX VI

CONTAINMENT FOR INDUSTRIAL PROCESSES

(Article 4(1) and Article 16(2)(a))

Preliminary note

In the table, “Recommended” means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.

Group 1 biological agents

For work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.

Groups 2, 3 and 4 biological agents

It may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.

| A. Containment measures | B. Containment levels |
| --- | --- |
| 2 | 3 | 4 |
| General |
| 1. Viable organisms should be handled in a system which physically separates the process from the environment | Yes | Yes | Yes |
| 2. Exhaust gases from the closed system should be treated so as to: | Minimise release | Prevent release | Prevent release |
| 3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to: | Minimise release | Prevent release | Prevent release |
| 4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been: | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means |
| 5. Seals should be designed so as to: | Minimise release | Prevent release | Prevent release |
| 6. The controlled area should be designed to contain spillage of the entire contents of the closed system | No | Recommended | Yes |
| 7. The controlled area should be sealable to permit fumigation | No | Recommended | Yes |
| Facilities |
| 8. Decontamination and washing facilities should be provided for personnel | Yes | Yes | Yes |
| Equipment |
| 9. Input air and extract air to the controlled area should be HEPA (4) filtered | No | Recommended | Yes |
| 10. The controlled area should be maintained at an air pressure negative to atmosphere | No | Recommended | Yes |
| 11. The controlled area should be adequately ventilated to minimise air contamination | Recommended | Recommended | Yes |
| System of work |
| 12. Closed systems (5) should be located within a controlled area | Recommended | Recommended | Yes, and purpose-built |
| 13. Biohazard signs should be posted | Recommended | Yes | Yes |
| 14. Access should be restricted to nominated personnel only | Recommended | Yes | Yes, via an airlock (6) |
| 15. Personnel should shower before leaving the controlled area | No | Recommended | Yes |
| 16. Personnel should wear protective clothing | Yes, work clothing | Yes | Yes, complete change |
| Waste |
| 17. Effluent from sinks and showers should be collected and inactivated before release | No | Recommended | Yes |
| 18. Effluent treatment before final discharge | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means | Inactivated by validated chemical or physical means |

A. Containment measures

B. Containment levels

2

3

4

General

1. Viable organisms should be handled in a system which physically separates the process from the environment

Yes

Yes

Yes

2. Exhaust gases from the closed system should be treated so as to:

Minimise release

Prevent release

Prevent release

3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:

Minimise release

Prevent release

Prevent release

4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

5. Seals should be designed so as to:

Minimise release

Prevent release

Prevent release

6. The controlled area should be designed to contain spillage of the entire contents of the closed system

No

Recommended

Yes

7. The controlled area should be sealable to permit fumigation

No

Recommended

Yes

Facilities

8. Decontamination and washing facilities should be provided for personnel

Yes

Yes

Yes

Equipment

9. Input air and extract air to the controlled area should be HEPA (4) filtered

No

Recommended

Yes

10. The controlled area should be maintained at an air pressure negative to atmosphere

No

Recommended

Yes

11. The controlled area should be adequately ventilated to minimise air contamination

Recommended

Recommended

Yes

System of work

12. Closed systems (5) should be located within a controlled area

Recommended

Recommended

Yes, and purpose-built

13. Biohazard signs should be posted

Recommended

Yes

Yes

14. Access should be restricted to nominated personnel only

Recommended

Yes

Yes, via an airlock (6)

15. Personnel should shower before leaving the controlled area

No

Recommended

Yes

16. Personnel should wear protective clothing

Yes, work clothing

Yes

Yes, complete change

Waste

17. Effluent from sinks and showers should be collected and inactivated before release

No

Recommended

Yes

18. Effluent treatment before final discharge

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

Inactivated by validated chemical or physical means

---

(*1)  See paragraph 8 of the introductory notes.

*1

(*2)  See paragraph 7 of the introductory notes.

*2

(1)  Classification according to WHO Global Action Plan to minimize poliovirus facility-associated risk after type-specific eradication of wild polioviruses and sequential cessation of oral polio vaccine use.

1

(*3)  See paragraph 8 of the introductory notes.

*3

(1)  Tick-borne encephalitis.

1

(2)  Hepatitis delta virus is pathogenic in workers only in the presence of simultaneous or secondary infection caused by hepatitis B virus. Vaccination against hepatitis B virus will therefore protect workers who are not affected by hepatitis B virus against hepatitis delta virus.

2

(3)  Only for types A and B.

3

(4)  Recommended for work involving direct contact with these agents.

4

(5)  Two viruses are identified: one a buffalopox type and the other a variant of the Vaccinia virus.

5

(6)  Variant of cowpox virus.

6

(7)  Variant of Vaccinia.

7

(8)  At present there is no evidence of disease in humans caused by the other retroviruses of simian origin. As a precaution containment level 3 is recommended for work with them.

8

(*4)  See paragraph 8 of the introductory notes.

*4

(9)  Recommended for work involving direct contact with these agents.

9

(*5)  See paragraph 8 of the introductory notes.

*5

(2)  HEPA: High efficiency particulate air

2

(3)  Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.

3

(4)  HEPA: High efficiency particulate air

4

(5)  Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).

5

(6)  Airlock: Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors.

6

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/80 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/80

---

COMMISSION DIRECTIVE (EU) 2019/1834

of 24 October 2019

amending Annexes II and IV to Council Directive 92/29/EEC as regards purely technical adaptations

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 92/29/EEC of 31 March 1992 on the minimum safety and health requirements for improved medical treatment on board vessels (1), and in particular Article 8 thereof,

Whereas:

| (1) | Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, states that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes improved medical treatment on board vessels. |
| --- | --- |

(1)

Principle 10 of the European Pillar of Social Rights (2), proclaimed at Gothenburg on 17 November 2017, states that every worker has the right to a healthy, safe and well-adapted working environment. The workers’ right to a high level of protection of their health and safety at work and to a working environment that is adapted to their professional needs and that enables them to prolong their participation in the labour market includes improved medical treatment on board vessels.

| (2) | The implementation of the directives related to the health and safety of workers at work, including Directive 92/29/EEC, was the subject of an ex post evaluation, referred to as REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the list of mandatory medical supplies in Annex II of Directive 92/29/EEC needs to be updated and that coherence with international instruments should be enhanced. |
| --- | --- |

(2)

The implementation of the directives related to the health and safety of workers at work, including Directive 92/29/EEC, was the subject of an ex post evaluation, referred to as REFIT evaluation. The evaluation looked at the directives’ relevance, at research and at new scientific knowledge in the various fields concerned. The REFIT evaluation, referred to in the Commission Staff Working Document (3), concludes, among other things, that the list of mandatory medical supplies in Annex II of Directive 92/29/EEC needs to be updated and that coherence with international instruments should be enhanced.

| (3) | In its Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational safety and health confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of mandatory medical supplies in Annex II to Directive 92/29/EEC. |
| --- | --- |

(3)

In its Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ (4), the Commission reiterated that while the REFIT evaluation of the Union’s acquis on occupational safety and health confirmed that the legislation in this field is generally effective and fit-for-purpose, there is scope for updating outdated rules and ensuring better and broader protection, compliance and enforcement on the ground. The Commission emphasises the particular need to update the list of mandatory medical supplies in Annex II to Directive 92/29/EEC.

| (4) | Directive 92/29/EEC lays down minimum safety and health requirements for improved medical treatment for persons carrying out an occupation on board a vessel. It lists the medical supplies required on board and addresses how responsibilities are assigned, information and training, and inspection. |
| --- | --- |

(4)

Directive 92/29/EEC lays down minimum safety and health requirements for improved medical treatment for persons carrying out an occupation on board a vessel. It lists the medical supplies required on board and addresses how responsibilities are assigned, information and training, and inspection.

| (5) | Annex II to Directive 92/29/EEC contains a non-exhaustive list of medical supplies required on board, including medicines, medical equipment and antidotes. The requirements as regards the medical supplies vary according to the category of vessel as defined in Annex I of that Directive. |
| --- | --- |

(5)

Annex II to Directive 92/29/EEC contains a non-exhaustive list of medical supplies required on board, including medicines, medical equipment and antidotes. The requirements as regards the medical supplies vary according to the category of vessel as defined in Annex I of that Directive.

| (6) | It is appropriate to amend Annex II to Directive 92/29/EEC in the light of the scientific and medical developments that have taken place since its adoption, particularly as regards the new medicines and medical equipment that have become available, and medicines or medical equipment which are not required to be carried on board any more. Moreover, in several instances, medical practice has shown that the wording of existing entries in Annex II to Directive 92/29/EEC needs to be updated or adapted to reflect current practices more closely. |
| --- | --- |

(6)

It is appropriate to amend Annex II to Directive 92/29/EEC in the light of the scientific and medical developments that have taken place since its adoption, particularly as regards the new medicines and medical equipment that have become available, and medicines or medical equipment which are not required to be carried on board any more. Moreover, in several instances, medical practice has shown that the wording of existing entries in Annex II to Directive 92/29/EEC needs to be updated or adapted to reflect current practices more closely.

| (7) | Vessels staying very close to shore or with no cabin accommodation belonging to category C should be given particular consideration as these vessels tend to be smaller and may lack the space for full medical supplies. Annex II to Directive 92/29/EEC should therefore allow Member States to consider, under exceptional circumstances, the use of alternatives (medicines or medical equipment) for objectively justified reasons. Given the specificities of category C vessels, there is no need to carry certain items on board and therefore the list of medicines and medical equipment of that category should be slightly shortened. |
| --- | --- |

(7)

Vessels staying very close to shore or with no cabin accommodation belonging to category C should be given particular consideration as these vessels tend to be smaller and may lack the space for full medical supplies. Annex II to Directive 92/29/EEC should therefore allow Member States to consider, under exceptional circumstances, the use of alternatives (medicines or medical equipment) for objectively justified reasons. Given the specificities of category C vessels, there is no need to carry certain items on board and therefore the list of medicines and medical equipment of that category should be slightly shortened.

| (8) | Annex IV to Directive 92/29/EEC should be amended to take into account the amendment of Annex II, because Annex IV lays down a general framework for the inspection of the vessels’ medical supplies and as such is closely related to Annex II and reproduces its contents for inspection purposes. |
| --- | --- |

(8)

Annex IV to Directive 92/29/EEC should be amended to take into account the amendment of Annex II, because Annex IV lays down a general framework for the inspection of the vessels’ medical supplies and as such is closely related to Annex II and reproduces its contents for inspection purposes.

| (9) | Annexes II and IV to Directive 92/29/EEC should be amended to take into account international instruments, such as the International Medical Guide for Ships (5), as well as to maintain the existing levels of protection for persons carrying out an occupation on board a vessel, and to reflect scientific and medical developments in the area, requiring merely technical adjustments at the workplace. |
| --- | --- |

(9)

Annexes II and IV to Directive 92/29/EEC should be amended to take into account international instruments, such as the International Medical Guide for Ships (5), as well as to maintain the existing levels of protection for persons carrying out an occupation on board a vessel, and to reflect scientific and medical developments in the area, requiring merely technical adjustments at the workplace.

| (10) | The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational safety and health legislation effective and fit-for-purpose. |
| --- | --- |

(10)

The Advisory Committee for Safety and Health at Work was consulted on the measures resulting from the adoption of the Commission’s Communication ‘Safer and Healthier Work for All — Modernisation of the EU Occupational Safety and Health Legislation and Policy’ that are required to keep the Union’s occupational safety and health legislation effective and fit-for-purpose.

| (11) | In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (6), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated. |
| --- | --- |

(11)

In its ‘Opinion on the Modernisation of Six OSH Directives to Ensure Healthier and Safer Work for All’ (6), adopted on 6 December 2017, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated.

| (12) | In a subsequent ‘Opinion on the Technical updates of annexes of the Directive Medical Treatment on board (92/29)’ (7), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated to take into account the latest technological and medical developments in the field. |
| --- | --- |

(12)

In a subsequent ‘Opinion on the Technical updates of annexes of the Directive Medical Treatment on board (92/29)’ (7), adopted on 31 May 2018, the Advisory Committee for Safety and Health at Work recommends that Annexes II and IV to Directive 92/29/EEC should be updated to take into account the latest technological and medical developments in the field.

| (13) | The Commission was assisted by experts representing the Member States, who provided technical and scientific support. |
| --- | --- |

(13)

The Commission was assisted by experts representing the Member States, who provided technical and scientific support.

| (14) | In accordance with the Joint Political Declaration on explanatory documents (8), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. |
| --- | --- |

(14)

In accordance with the Joint Political Declaration on explanatory documents (8), adopted by the Member States and the Commission on 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

| (15) | The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 8 of Directive 92/29/EEC, |
| --- | --- |

(15)

The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 8 of Directive 92/29/EEC,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II and IV to Directive 92/29/EEC are replaced by the text in the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 November 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 24 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 113, 30.4.1992, p. 19.

1

(2)  European Pillar of Social Rights, November 2017, https://ec.europa.eu/commission/priorities/deeper-and-fairer-economic-and-monetary-union/european-pillar-social-rights_en

2

(3)  SWD(2017) 10 final

3

(4)  COM(2017) 12 final

4

(5)  International medical guide for ships: including the ship’s medicine chest. 3rd ed., World Health Organization, 2007 (ISBN 978 92 4 154720 8)

5

(6)  Advisory Committee for Safety and Health at Work Doc. 1718/2017

6

(7)  Advisory Committee for Safety and Health at Work Doc. 444/18

7

(8)  
  OJ C 369, 17.12.2011, p. 14.

8

---

ANNEX

(1)

‘ANNEX II

MEDICAL SUPPLIES (NON-EXHAUSTIVE LIST) (*)

(Article 1(d))

(*) In light of Article 2(1)(a) Member States may, under exceptional circumstances, consider the use of alternative medicines or medical equipment for objectively justified reasons.

I.   
  MEDICINES

| | Categories of vessels |
| --- | --- |
| | A | B | C |
| 1. Cardiovascular | | | |
| (a) Cardio-circulatory sympathomimetics | x | x | |
| (b) Anti-angina preparations | x | x | x |
| (c) Diuretics | x | x | |
| (d) Anti-haemorrhagics including uterotonics if there are women on board | x | x | |
| (e) Anti-hypertensive | x | x | |
| 2. Gastro-intestinal system | | | |
| (a) Medicines for gastric and duodenal disorders | | | |
| — Medicine for treatment of stomach ulcer and gastritis | x | x | |
| — Anti-acid mucous dressings | x | x | |
| (b) Anti-emetics | x | x | |
| (c) Laxatives | x | | |
| (d) Anti-diarrhoeals | x | x | x |
| (e) Haemorrhoid preparations | x | x | |
| 3. Analgesics and anti-spasmodics | | | |
| (a) Analgesics, anti-pyretics and anti-inflammatory preparations | x | x | x |
| (b) Powerful analgesics | x | x | |
| (c) Spasmolytics | x | x | |
| 4. Nervous system | | | |
| (a) Anxiolytics | x | x | |
| (b) Neuroleptics | x | x | |
| (c) Seasickness remedies | x | x | x |
| (d) Anti-epileptics | x | x | |
| 5. Anti-allergics and anti-anaphylactics | | | |
| (a) Anti-histaminics | x | x | |
| (b) Glucocorticoids | x | x | |
| 6. Respiratory system | | | |
| (a) Bronchiospasm preparations | x | x | |
| (b) Anti-tussives | x | x | |
| (c) Medicines used for colds and sinusitis | x | x | |
| 7. Anti-infection | | | |
| (a) Antibiotics (at least two classes) | x | x | |
| (b) Anti-parasitics | x | x | |
| (c) Anti-tetanus vaccines and immunoglobulins | x | x | |
| (d) Anti-malaria medicines, carriage shall be dependent upon operational area | x | x | |
| 8. Compounds promoting rehydration, caloric intake and plasma expansion | x | x | |
| 9. Medicines for external use | | | |
| (a) Skin medicines | | | |
| — Antiseptic solutions | x | x | x |
| — Antibiotic ointments | x | x | |
| — Anti-inflammatory and analgesic ointments | x | x | |
| — Anti-mycotic skin creams | x | | |
| — Burn preparations | x | x | x |
| (b) Eye medicines | | | |
| — Antibiotic and anti-inflammatory | x | x | |
| — Anaesthetic drops | x | x | |
| — Saline solution for eyewash | x | x | x |
| — Hypotonic myotic drops | x | x | |
| (c) Ear medicines | | | |
| — Anaesthetic and anti-inflammatory solutions | x | x | |
| (d) Medicines for oral and throat infections | | | |
| — Antiseptic mouthwashes | x | x | |
| (e) Local anaesthetics | | | |
| — Local anaesthetics using freezing | x | | |
| — Local anaesthetics given by subcutaneous injection | x | x | |

Categories of vessels

A

B

C

1. Cardiovascular

(a) Cardio-circulatory sympathomimetics

x

x

(b) Anti-angina preparations

x

x

x

(c) Diuretics

x

x

(d) Anti-haemorrhagics including uterotonics if there are women on board

x

x

(e) Anti-hypertensive

x

x

2. Gastro-intestinal system

(a) Medicines for gastric and duodenal disorders

— Medicine for treatment of stomach ulcer and gastritis

x

x

— Anti-acid mucous dressings

x

x

(b) Anti-emetics

x

x

(c) Laxatives

x

(d) Anti-diarrhoeals

x

x

x

(e) Haemorrhoid preparations

x

x

3. Analgesics and anti-spasmodics

(a) Analgesics, anti-pyretics and anti-inflammatory preparations

x

x

x

(b) Powerful analgesics

x

x

(c) Spasmolytics

x

x

4. Nervous system

(a) Anxiolytics

x

x

(b) Neuroleptics

x

x

(c) Seasickness remedies

x

x

x

(d) Anti-epileptics

x

x

5. Anti-allergics and anti-anaphylactics

(a) Anti-histaminics

x

x

(b) Glucocorticoids

x

x

6. Respiratory system

(a) Bronchiospasm preparations

x

x

(b) Anti-tussives

x

x

(c) Medicines used for colds and sinusitis

x

x

7. Anti-infection

(a) Antibiotics (at least two classes)

x

x

(b) Anti-parasitics

x

x

(c) Anti-tetanus vaccines and immunoglobulins

x

x

(d) Anti-malaria medicines, carriage shall be dependent upon operational area

x

x

8. Compounds promoting rehydration, caloric intake and plasma expansion

x

x

9. Medicines for external use

(a) Skin medicines

— Antiseptic solutions

x

x

x

— Antibiotic ointments

x

x

— Anti-inflammatory and analgesic ointments

x

x

— Anti-mycotic skin creams

x

— Burn preparations

x

x

x

(b) Eye medicines

— Antibiotic and anti-inflammatory

x

x

— Anaesthetic drops

x

x

— Saline solution for eyewash

x

x

x

— Hypotonic myotic drops

x

x

(c) Ear medicines

— Anaesthetic and anti-inflammatory solutions

x

x

(d) Medicines for oral and throat infections

— Antiseptic mouthwashes

x

x

(e) Local anaesthetics

— Local anaesthetics using freezing

x

— Local anaesthetics given by subcutaneous injection

x

x

II.   
  MEDICAL EQUIPMENT

| | Categories of vessels |
| --- | --- |
| | A | B | C |
| 1. Resuscitation equipment | | | |
| — Ambu bag (or equivalent); supplied with large, medium and small masks | x | x | |
| — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (1) | x | x | |
| — Mechanical aspirator to clear upper respiratory passages | x | x | |
| 2. Dressing and suturing equipment | | | |
| — Tourniquets | x | x | x |
| — Disposable suture stapler or suture kit with needles | x | x | |
| — Adhesive elastic bandage | x | x | x |
| — Gauze strips | x | x | |
| — Tubular gauze for finger bandages | x | | |
| — Sterile gauze compresses | x | x | x |
| — Sterile sheet for burns victims | x | x | |
| — Triangular sling | x | x | |
| — Disposable gloves | x | x | x |
| — Adhesive dressings | x | x | x |
| — Sterile compression bandages | x | x | x |
| — Adhesive sutures or zinc oxide bandages | x | x | x |
| — Non-absorbable sutures with needles | x | | |
| — Vaseline gauze | x | x | |
| 3. Instruments | | | |
| — Disposable scalpels | x | | |
| — Instrument box made of suitable material | x | x | |
| — Scissors | x | x | |
| — Dissecting forceps | x | x | |
| — Haemostatic clamps | x | x | |
| — Needle forceps | x | | |
| — Disposable razors | x | | |
| 4. Examination and monitoring equipment | | | |
| — Disposable tongue depressors | x | x | |
| — Reactive strips for urine analysis | x | | |
| — Temperature charts | x | | |
| — Medical evacuation sheets | x | x | |
| — Stethoscope | x | x | |
| — Sphygmomanometer | x | x | |
| — Medical thermometer | x | x | |
| — Hypothermic thermometer | x | x | |
| — Quick malaria test, carriage shall be dependent upon operational area | x | x | |
| 5. Equipment for injection, perfusion, puncture and catheterisation | | | |
| — Bladder drainage equipment (suitable for men and women) | x | | |
| — Intravenous infusion set | x | x | |
| — Disposable syringes and needles | x | x | |
| 6. General medical equipment | | | |
| — Personal protective medical and nursing equipment | x | x | |
| — Bedpan | x | | |
| — Hot-water bottle | x | | |
| — Urine bottle | x | | |
| — Ice bag | x | | |
| 7. Immobilisation and setting equipment | | | |
| — Set of splints of different sizes for the extremities | x | x | |
| — Collar for neck immobilisation | x | x | |
| 8. Disinfection, disinsectisation and prophylaxis | | | |
| — Water-disinfection compound | x | | |
| — Liquid insecticide | x | | |
| — Powder insecticide | x | | |

Categories of vessels

A

B

C

1. Resuscitation equipment

— Ambu bag (or equivalent); supplied with large, medium and small masks

x

x

— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (1)

x

x

— Mechanical aspirator to clear upper respiratory passages

x

x

2. Dressing and suturing equipment

— Tourniquets

x

x

x

— Disposable suture stapler or suture kit with needles

x

x

— Adhesive elastic bandage

x

x

x

— Gauze strips

x

x

— Tubular gauze for finger bandages

x

— Sterile gauze compresses

x

x

x

— Sterile sheet for burns victims

x

x

— Triangular sling

x

x

— Disposable gloves

x

x

x

— Adhesive dressings

x

x

x

— Sterile compression bandages

x

x

x

— Adhesive sutures or zinc oxide bandages

x

x

x

— Non-absorbable sutures with needles

x

— Vaseline gauze

x

x

3. Instruments

— Disposable scalpels

x

— Instrument box made of suitable material

x

x

— Scissors

x

x

— Dissecting forceps

x

x

— Haemostatic clamps

x

x

— Needle forceps

x

— Disposable razors

x

4. Examination and monitoring equipment

— Disposable tongue depressors

x

x

— Reactive strips for urine analysis

x

— Temperature charts

x

— Medical evacuation sheets

x

x

— Stethoscope

x

x

— Sphygmomanometer

x

x

— Medical thermometer

x

x

— Hypothermic thermometer

x

x

— Quick malaria test, carriage shall be dependent upon operational area

x

x

5. Equipment for injection, perfusion, puncture and catheterisation

— Bladder drainage equipment (suitable for men and women)

x

— Intravenous infusion set

x

x

— Disposable syringes and needles

x

x

6. General medical equipment

— Personal protective medical and nursing equipment

x

x

— Bedpan

x

— Hot-water bottle

x

— Urine bottle

x

— Ice bag

x

7. Immobilisation and setting equipment

— Set of splints of different sizes for the extremities

x

x

— Collar for neck immobilisation

x

x

8. Disinfection, disinsectisation and prophylaxis

— Water-disinfection compound

x

— Liquid insecticide

x

— Powder insecticide

x

III.   
  ANTIDOTES

| 1. Medicines |
| --- |
| — General |
| — Cardio-vascular |
| — Gastro-intestinal system |
| — Nervous system |
| — Respiratory system |
| — Anti-infective |
| — For external use |
| 2. Medical equipment |
| — Necessary for the administration of oxygen (including maintenance requisites) |

1. Medicines

— General

— Cardio-vascular

— Gastro-intestinal system

— Nervous system

— Respiratory system

— Anti-infective

— For external use

2. Medical equipment

— Necessary for the administration of oxygen (including maintenance requisites)

Note:

For the detailed implementation of Section III, Member States may refer to the IMO Medical First Aid Guide for use in accidents involving dangerous goods (MFAG) contained in the 1990 consolidated edition of the IMO International Maritime Dangerous Goods Code, as amended.

Any adaptation of Section III in implementation of Article 8 may take account, inter alia, of any updating of the MFAG.

(2)

‘ANNEX IV

General Framework for the Inspection of Vessels’ Medical Supplies

(Article 2(1)(c), Article 3(3))

SECTION A

CATEGORY A VESSELS

I.   Details of the vessel

Name: ...

Flag: ...

Home port: ...

II.   Medical supplies

| | Quantities required | Quantities actually carried on board | Remarks (in particular, any expiry date) |
| --- | --- | --- | --- |
| 1. MEDICINE |
| 1.1. Cardiovascular | |
| (a) Cardio-circulatory sympathomimetics | 0 | 0 | 0 |
| (b) Anti-angina preparations | 0 | 0 | 0 |
| (c) Diuretics | 0 | 0 | 0 |
| (d) Anti-haemorrhagics including uterotonics if there are women on board | 0 | 0 | 0 |
| (e) Anti-hypertensive | 0 | 0 | 0 |
| 1.2. Gastro-intestinal system | | | |
| (a) Medicines for gastric and duodenal disorders | 0 | 0 | 0 |
| — Medicine for treatment of stomach ulcer and gastritis | 0 | 0 | 0 |
| — Anti-acid mucous dressings | 0 | 0 | 0 |
| (b) Anti-emetics | 0 | 0 | 0 |
| (c) Laxatives | 0 | 0 | 0 |
| (d) Anti-diarrhoeals | 0 | 0 | 0 |
| (e) Haemorrhoid preparations | 0 | 0 | 0 |
| 1.3. Analgesics and anti-spasmodics | | | |
| (a) Analgesics, anti-pyretics and anti-inflammatory preparations | 0 | 0 | 0 |
| (b) Powerful analgesics | 0 | 0 | 0 |
| (c) Spasmolytics | 0 | 0 | 0 |
| 1.4. Nervous system | | | |
| (a) Anxiolytics | 0 | 0 | 0 |
| (b) Neuroleptics | 0 | 0 | 0 |
| (c) Seasickness remedies | 0 | 0 | 0 |
| (d) Anti-epileptics | 0 | 0 | 0 |
| 1.5. Anti-allergics and anti-anaphylactics | | | |
| (a) Anti-histaminics | 0 | 0 | 0 |
| (b) Glucocorticoids | 0 | 0 | 0 |
| 1.6. Respiratory system | | | |
| (a) Bronchiospasm preparations | 0 | 0 | 0 |
| (b) Anti-tussives | 0 | 0 | 0 |
| (c) Medicines used for colds and sinusitis | 0 | 0 | 0 |
| 1.7. Anti-infection | | | |
| (a) Antibiotics (at least two classes) | 0 | 0 | 0 |
| (b) Anti-parasitics | 0 | 0 | 0 |
| (c) Anti-tetanus vaccines and immunoglobulins | 0 | 0 | 0 |
| (d) Anti-malaria medicines, carriage shall be dependent upon operational area | 0 | 0 | 0 |
| 1.8. Compounds promoting rehydration, caloric intake and plasma expansion | 0 | 0 | 0 |
| 1.9. Medicines for external use | | | |
| (a) Skin medicines | 0 | 0 | 0 |
| — Antiseptic solutions | 0 | 0 | 0 |
| — Antibiotic ointments | 0 | 0 | 0 |
| — Anti-inflammatory and analgesic ointments | 0 | 0 | 0 |
| — Anti-mycotic skin creams | 0 | 0 | 0 |
| — Burn preparations | 0 | 0 | 0 |
| (b) Eye medicines | 0 | 0 | 0 |
| — Antibiotic and anti-inflammatory | 0 | 0 | 0 |
| — Anaesthetic drops | 0 | 0 | 0 |
| — Saline solution for eyewash | 0 | 0 | 0 |
| — Hypotonic myotic drops | 0 | 0 | 0 |
| (c) Ear medicines | 0 | 0 | 0 |
| — Anaesthetic and anti-inflammatory solutions | 0 | 0 | 0 |
| (d) Medicines for oral and throat infections | 0 | 0 | 0 |
| — Antiseptic mouthwashes | 0 | 0 | 0 |
| (e) Local anaesthetics | 0 | 0 | 0 |
| — Local anaesthetics using freezing | 0 | 0 | 0 |
| — Local anaesthetics given by subcutaneous injection | 0 | 0 | 0 |
| 2. MEDICAL EQUIPMENT |
| 2.1. Resuscitation equipment | |
| — Ambu bag (or equivalent); supplied with large, medium and small masks | 0 | 0 | 0 |
| — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (2) | 0 | 0 | 0 |
| — Mechanical aspirator to clear upper respiratory passages | 0 | 0 | 0 |
| 2.2. Dressing and suturing equipment |
| — Tourniquets | 0 | 0 | 0 |
| — Disposable suture stapler or suture kit with needles | 0 | 0 | 0 |
| — Adhesive elastic bandage | 0 | 0 | 0 |
| — Gauze strips | 0 | 0 | 0 |
| — Tubular gauze for finger bandages | 0 | 0 | 0 |
| — Sterile gauze compresses | 0 | 0 | 0 |
| — Sterile sheet for burns victims | 0 | 0 | 0 |
| — Triangular sling | 0 | 0 | 0 |
| — Disposable gloves | 0 | 0 | 0 |
| — Adhesive dressings | 0 | 0 | 0 |
| — Sterile compression bandages | 0 | 0 | 0 |
| — Adhesive sutures or zinc oxide bandages | 0 | 0 | 0 |
| — Non-absorbable sutures with needles | 0 | 0 | 0 |
| — Vaseline gauze | 0 | 0 | 0 |
| 2.3. Instruments |
| — Disposable scalpels | 0 | 0 | 0 |
| — Instrument box made of suitable material | 0 | 0 | 0 |
| — Scissors | 0 | 0 | 0 |
| — Dissecting forceps | 0 | 0 | 0 |
| — Haemostatic clamps | 0 | 0 | 0 |
| — Needle forceps | 0 | 0 | 0 |
| — Disposable razors | 0 | 0 | 0 |
| 2.4. Examination and monitoring equipment | 0 | 0 | 0 |
| — Disposable tongue depressors | 0 | 0 | 0 |
| — Reactive strips for urine analysis | 0 | 0 | 0 |
| — Temperature charts | 0 | 0 | 0 |
| — Medical evacuation sheets | 0 | 0 | 0 |
| — Stethoscope | 0 | 0 | 0 |
| — Sphygmomanometer | 0 | 0 | 0 |
| — Medical thermometer | 0 | 0 | 0 |
| — Hypothermic thermometer | 0 | 0 | 0 |
| —Quick malaria test, carriage shall be dependent upon operational area | 0 | 0 | 0 |
| 2.5. Equipment for injection, perfusion, puncture and catheterisation | 0 | 0 | 0 |
| — Bladder drainage equipment (suitable for men and women) | 0 | 0 | 0 |
| — Intravenous infusion set | 0 | 0 | 0 |
| — Disposable syringes and needles | 0 | 0 | 0 |
| 2.6. General medical equipment | 0 | 0 | 0 |
| — Personal protective medical and nursing equipment | 0 | 0 | 0 |
| — Bedpan | 0 | 0 | 0 |
| — Hot-water bottle | 0 | 0 | 0 |
| — Urine bottle | 0 | 0 | 0 |
| — Ice bag | 0 | 0 | 0 |
| 2.7. Immobilisation and setting equipment | 0 | 0 | 0 |
| — Set of splints of different sizes for the extremities | 0 | 0 | 0 |
| — Collar for neck immobilisation | 0 | 0 | 0 |
| 2.8. Disinfection, disinsectisation and prophylaxis | 0 | 0 | 0 |
| — Water-disinfection compound | 0 | 0 | 0 |
| — Liquid insecticide | 0 | 0 | 0 |
| — Powder insecticide | 0 | 0 | 0 |
| 3. ANTIDOTES |
| 3.1. General | 0 | 0 | 0 |
| 3.2. Cardio-vascular | 0 | 0 | 0 |
| 3.3. Gastro-intestinal system | 0 | 0 | 0 |
| 3.4. Nervous system | 0 | 0 | 0 |
| 3.5. Respiratory system | 0 | 0 | 0 |
| 3.6. Anti-infective | 0 | 0 | 0 |
| 3.7. For external use | 0 | 0 | 0 |
| 3.8. Other | 0 | 0 | 0 |
| 3.9. Necessary for the administration of oxygen (including maintenance requisites) | 0 | 0 | 0 |

Quantities required

Quantities actually carried on board

Remarks (in particular, any expiry date)

1. MEDICINE

1.1. Cardiovascular

(a) Cardio-circulatory sympathomimetics

0

0

0

(b) Anti-angina preparations

0

0

0

(c) Diuretics

0

0

0

(d) Anti-haemorrhagics including uterotonics if there are women on board

0

0

0

(e) Anti-hypertensive

0

0

0

1.2. Gastro-intestinal system

(a) Medicines for gastric and duodenal disorders

0

0

0

— Medicine for treatment of stomach ulcer and gastritis

0

0

0

— Anti-acid mucous dressings

0

0

0

(b) Anti-emetics

0

0

0

(c) Laxatives

0

0

0

(d) Anti-diarrhoeals

0

0

0

(e) Haemorrhoid preparations

0

0

0

1.3. Analgesics and anti-spasmodics

(a) Analgesics, anti-pyretics and anti-inflammatory preparations

0

0

0

(b) Powerful analgesics

0

0

0

(c) Spasmolytics

0

0

0

1.4. Nervous system

(a) Anxiolytics

0

0

0

(b) Neuroleptics

0

0

0

(c) Seasickness remedies

0

0

0

(d) Anti-epileptics

0

0

0

1.5. Anti-allergics and anti-anaphylactics

(a) Anti-histaminics

0

0

0

(b) Glucocorticoids

0

0

0

1.6. Respiratory system

(a) Bronchiospasm preparations

0

0

0

(b) Anti-tussives

0

0

0

(c) Medicines used for colds and sinusitis

0

0

0

1.7. Anti-infection

(a) Antibiotics (at least two classes)

0

0

0

(b) Anti-parasitics

0

0

0

(c) Anti-tetanus vaccines and immunoglobulins

0

0

0

(d) Anti-malaria medicines, carriage shall be dependent upon operational area

0

0

0

1.8. Compounds promoting rehydration, caloric intake and plasma expansion

0

0

0

1.9. Medicines for external use

(a) Skin medicines

0

0

0

— Antiseptic solutions

0

0

0

— Antibiotic ointments

0

0

0

— Anti-inflammatory and analgesic ointments

0

0

0

— Anti-mycotic skin creams

0

0

0

— Burn preparations

0

0

0

(b) Eye medicines

0

0

0

— Antibiotic and anti-inflammatory

0

0

0

— Anaesthetic drops

0

0

0

— Saline solution for eyewash

0

0

0

— Hypotonic myotic drops

0

0

0

(c) Ear medicines

0

0

0

— Anaesthetic and anti-inflammatory solutions

0

0

0

(d) Medicines for oral and throat infections

0

0

0

— Antiseptic mouthwashes

0

0

0

(e) Local anaesthetics

0

0

0

— Local anaesthetics using freezing

0

0

0

— Local anaesthetics given by subcutaneous injection

0

0

0

2. MEDICAL EQUIPMENT

2.1. Resuscitation equipment

— Ambu bag (or equivalent); supplied with large, medium and small masks

0

0

0

— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (2)

0

0

0

— Mechanical aspirator to clear upper respiratory passages

0

0

0

2.2. Dressing and suturing equipment

— Tourniquets

0

0

0

— Disposable suture stapler or suture kit with needles

0

0

0

— Adhesive elastic bandage

0

0

0

— Gauze strips

0

0

0

— Tubular gauze for finger bandages

0

0

0

— Sterile gauze compresses

0

0

0

— Sterile sheet for burns victims

0

0

0

— Triangular sling

0

0

0

— Disposable gloves

0

0

0

— Adhesive dressings

0

0

0

— Sterile compression bandages

0

0

0

— Adhesive sutures or zinc oxide bandages

0

0

0

— Non-absorbable sutures with needles

0

0

0

— Vaseline gauze

0

0

0

2.3. Instruments

— Disposable scalpels

0

0

0

— Instrument box made of suitable material

0

0

0

— Scissors

0

0

0

— Dissecting forceps

0

0

0

— Haemostatic clamps

0

0

0

— Needle forceps

0

0

0

— Disposable razors

0

0

0

2.4. Examination and monitoring equipment

0

0

0

— Disposable tongue depressors

0

0

0

— Reactive strips for urine analysis

0

0

0

— Temperature charts

0

0

0

— Medical evacuation sheets

0

0

0

— Stethoscope

0

0

0

— Sphygmomanometer

0

0

0

— Medical thermometer

0

0

0

— Hypothermic thermometer

0

0

0

—Quick malaria test, carriage shall be dependent upon operational area

0

0

0

2.5. Equipment for injection, perfusion, puncture and catheterisation

0

0

0

— Bladder drainage equipment (suitable for men and women)

0

0

0

— Intravenous infusion set

0

0

0

— Disposable syringes and needles

0

0

0

2.6. General medical equipment

0

0

0

— Personal protective medical and nursing equipment

0

0

0

— Bedpan

0

0

0

— Hot-water bottle

0

0

0

— Urine bottle

0

0

0

— Ice bag

0

0

0

2.7. Immobilisation and setting equipment

0

0

0

— Set of splints of different sizes for the extremities

0

0

0

— Collar for neck immobilisation

0

0

0

2.8. Disinfection, disinsectisation and prophylaxis

0

0

0

— Water-disinfection compound

0

0

0

— Liquid insecticide

0

0

0

— Powder insecticide

0

0

0

3. ANTIDOTES

3.1. General

0

0

0

3.2. Cardio-vascular

0

0

0

3.3. Gastro-intestinal system

0

0

0

3.4. Nervous system

0

0

0

3.5. Respiratory system

0

0

0

3.6. Anti-infective

0

0

0

3.7. For external use

0

0

0

3.8. Other

0

0

0

3.9. Necessary for the administration of oxygen (including maintenance requisites)

0

0

0

Venue and date: ...

Captain’s signature: ...

Authorisation by competent person or authority: ...

SECTION B

CATEGORY B VESSELS

I.   Details of the vessel

Name: ...

Flag: ...

Home port: ...

II.   Medical supplies

| | Quantities required | Quantities actually carried on board | Remarks (in particular, any expiry date) |
| --- | --- | --- | --- |
| 1. MEDICINE |
| 1.1. Cardiovascular | |
| (a) Cardio-circulatory sympathomimetics | 0 | 0 | 0 |
| (b) Anti-angina preparations | 0 | 0 | 0 |
| (c) Diuretics | 0 | 0 | 0 |
| (d) Anti-haemorrhagics including uterotonics if there are women on board | 0 | 0 | 0 |
| (e) Anti-hypertensive | 0 | 0 | 0 |
| 1.2. Gastro-intestinal system | | | |
| (a) Medicines for gastric and duodenal disorders | 0 | 0 | 0 |
| — Medicine for treatment of stomach ulcer and gastritis | 0 | 0 | 0 |
| — Anti-acid mucous dressings | 0 | 0 | 0 |
| (b) Anti-emetics | 0 | 0 | 0 |
| (c) Anti-diarrhoeals | 0 | 0 | 0 |
| (d) Haemorrhoid preparations | 0 | 0 | 0 |
| 1.3. Analgesics and anti-spasmodics | | | |
| (a) Analgesics, anti-pyretics and anti-inflammatory preparations | 0 | 0 | 0 |
| (b) Powerful analgesics | 0 | 0 | 0 |
| (c) Spasmolytics | 0 | 0 | 0 |
| 1.4. Nervous system | | | |
| (a) Anxiolytics | 0 | 0 | 0 |
| (b) Neuroleptics | 0 | 0 | 0 |
| (c) Seasickness remedies | 0 | 0 | 0 |
| (d) Anti-epileptics | 0 | 0 | 0 |
| 1.5. Anti-allergics and anti-anaphylactics | | | |
| (a) Anti-histaminics | 0 | 0 | 0 |
| (b) Glucocorticoids | 0 | 0 | 0 |
| 1.6. Respiratory system | | | |
| (a) Bronchiospasm preparations | 0 | 0 | 0 |
| (b) Anti-tussives | 0 | 0 | 0 |
| (c) Medicines used for colds and sinusitis | 0 | 0 | 0 |
| 1.7. Anti-infection | | | |
| (a) Antibiotics (at least two classes) | 0 | 0 | 0 |
| (b) Anti-parasitics | 0 | 0 | 0 |
| (c) Anti-tetanus vaccines and immunoglobulins | 0 | 0 | 0 |
| (d) Anti-malaria medicines, carriage shall be dependent upon operational area | 0 | 0 | 0 |
| 1.8. Compounds promoting rehydration, caloric intake and plasma expansion | 0 | 0 | 0 |
| 1.9. Medicines for external use | | | |
| (a) Skin medicines | 0 | 0 | 0 |
| — Antiseptic solutions | 0 | 0 | 0 |
| — Antibiotic ointments | 0 | 0 | 0 |
| — Anti-inflammatory and analgesic ointments | 0 | 0 | 0 |
| — Burn preparations | 0 | 0 | 0 |
| (b) Eye medicines | 0 | 0 | 0 |
| — Antibiotic and anti-inflammatory | 0 | 0 | 0 |
| — Anaesthetic drops | 0 | 0 | 0 |
| — Saline solution for eyewash | 0 | 0 | 0 |
| — Hypotonic myotic drops | 0 | 0 | 0 |
| (c) Ear medicines | 0 | 0 | 0 |
| — Anaesthetic and anti-inflammatory solutions | 0 | 0 | 0 |
| (d) Medicines for oral and throat infections | 0 | 0 | 0 |
| — Antiseptic mouthwashes | 0 | 0 | 0 |
| (e) Local anaesthetics | 0 | 0 | 0 |
| — Local anaesthetics given by subcutaneous injection | 0 | 0 | 0 |
| 2. MEDICAL EQUIPMENT |
| 2.1 Resuscitation equipment | |
| — Ambu bag (or equivalent); supplied with large, medium and small masks | 0 | 0 | 0 |
| — Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (3) | 0 | 0 | 0 |
| — Mechanical aspirator to clear upper respiratory passages | 0 | 0 | 0 |
| 2.2. Dressing and suturing equipment |
| — Tourniquets | 0 | 0 | 0 |
| — Disposable suture stapler or suture kit with needles | 0 | 0 | 0 |
| — Adhesive elastic bandage | 0 | 0 | 0 |
| — Gauze strips | 0 | 0 | 0 |
| — Sterile gauze compresses | 0 | 0 | 0 |
| — Sterile sheet for burns victims | 0 | 0 | 0 |
| — Triangular sling | 0 | 0 | 0 |
| — Disposable gloves | 0 | 0 | 0 |
| — Adhesive dressings | 0 | 0 | 0 |
| — Sterile compression bandages | 0 | 0 | 0 |
| — Adhesive sutures or zinc oxide bandages | 0 | 0 | 0 |
| — Vaseline gauze | 0 | 0 | 0 |
| 2.3. Instruments |
| — Instrument box made of suitable material | 0 | 0 | 0 |
| — Scissors | 0 | 0 | 0 |
| — Dissecting forceps | 0 | 0 | 0 |
| — Haemostatic clamps | 0 | 0 | 0 |
| 2.4. Examination and monitoring equipment | 0 | 0 | 0 |
| — Disposable tongue depressors | 0 | 0 | 0 |
| — Medical evacuation sheets | 0 | 0 | 0 |
| — Stethoscope | 0 | 0 | 0 |
| — Sphygmomanometer | 0 | 0 | 0 |
| — Medical thermometer | 0 | 0 | 0 |
| — Hypothermic thermometer | 0 | 0 | 0 |
| —Quick malaria test, carriage shall be dependent upon operational area | 0 | 0 | 0 |
| 2.5.
  Equipment for injection, perfusion, puncture and catheterisation | 0 | 0 | 0 |
| — Intravenous infusion set | 0 | 0 | 0 |
| — Disposable syringes and needles | 0 | 0 | 0 |
| 2.6.
  General medical equipment | 0 | 0 | 0 |
| — Personal protective medical and nursing equipment | 0 | 0 | 0 |
| 2.7.
  Immobilisation and setting equipment | 0 | 0 | 0 |
| — Set of splints of different sizes for the extremities | 0 | 0 | 0 |
| — Collar for neck immobilisation | 0 | 0 | 0 |
| 3. ANTIDOTES |
| 3.1. General | 0 | 0 | 0 |
| 3.2. Cardio-vascular | 0 | 0 | 0 |
| 3.3. Gastro-intestinal system | 0 | 0 | 0 |
| 3.4. Nervous system | 0 | 0 | 0 |
| 3.5. Respiratory system | 0 | 0 | 0 |
| 3.6. Anti-infective | 0 | 0 | 0 |
| 3.7. For external use | 0 | 0 | 0 |
| 3.8. Other | 0 | 0 | 0 |
| 3.9. Necessary for the administration of oxygen (including maintenance requisites) | 0 | 0 | 0 |

Quantities required

Quantities actually carried on board

Remarks (in particular, any expiry date)

1. MEDICINE

1.1. Cardiovascular

(a) Cardio-circulatory sympathomimetics

0

0

0

(b) Anti-angina preparations

0

0

0

(c) Diuretics

0

0

0

(d) Anti-haemorrhagics including uterotonics if there are women on board

0

0

0

(e) Anti-hypertensive

0

0

0

1.2. Gastro-intestinal system

(a) Medicines for gastric and duodenal disorders

0

0

0

— Medicine for treatment of stomach ulcer and gastritis

0

0

0

— Anti-acid mucous dressings

0

0

0

(b) Anti-emetics

0

0

0

(c) Anti-diarrhoeals

0

0

0

(d) Haemorrhoid preparations

0

0

0

1.3. Analgesics and anti-spasmodics

(a) Analgesics, anti-pyretics and anti-inflammatory preparations

0

0

0

(b) Powerful analgesics

0

0

0

(c) Spasmolytics

0

0

0

1.4. Nervous system

(a) Anxiolytics

0

0

0

(b) Neuroleptics

0

0

0

(c) Seasickness remedies

0

0

0

(d) Anti-epileptics

0

0

0

1.5. Anti-allergics and anti-anaphylactics

(a) Anti-histaminics

0

0

0

(b) Glucocorticoids

0

0

0

1.6. Respiratory system

(a) Bronchiospasm preparations

0

0

0

(b) Anti-tussives

0

0

0

(c) Medicines used for colds and sinusitis

0

0

0

1.7. Anti-infection

(a) Antibiotics (at least two classes)

0

0

0

(b) Anti-parasitics

0

0

0

(c) Anti-tetanus vaccines and immunoglobulins

0

0

0

(d) Anti-malaria medicines, carriage shall be dependent upon operational area

0

0

0

1.8. Compounds promoting rehydration, caloric intake and plasma expansion

0

0

0

1.9. Medicines for external use

(a) Skin medicines

0

0

0

— Antiseptic solutions

0

0

0

— Antibiotic ointments

0

0

0

— Anti-inflammatory and analgesic ointments

0

0

0

— Burn preparations

0

0

0

(b) Eye medicines

0

0

0

— Antibiotic and anti-inflammatory

0

0

0

— Anaesthetic drops

0

0

0

— Saline solution for eyewash

0

0

0

— Hypotonic myotic drops

0

0

0

(c) Ear medicines

0

0

0

— Anaesthetic and anti-inflammatory solutions

0

0

0

(d) Medicines for oral and throat infections

0

0

0

— Antiseptic mouthwashes

0

0

0

(e) Local anaesthetics

0

0

0

— Local anaesthetics given by subcutaneous injection

0

0

0

2. MEDICAL EQUIPMENT

2.1 Resuscitation equipment

— Ambu bag (or equivalent); supplied with large, medium and small masks

0

0

0

— Appliance for the administration of oxygen with pressure-reducing valve such that ship’s industrial oxygen can be used, or oxygen container (3)

0

0

0

— Mechanical aspirator to clear upper respiratory passages

0

0

0

2.2. Dressing and suturing equipment

— Tourniquets

0

0

0

— Disposable suture stapler or suture kit with needles

0

0

0

— Adhesive elastic bandage

0

0

0

— Gauze strips

0

0

0

— Sterile gauze compresses

0

0

0

— Sterile sheet for burns victims

0

0

0

— Triangular sling

0

0

0

— Disposable gloves

0

0

0

— Adhesive dressings

0

0

0

— Sterile compression bandages

0

0

0

— Adhesive sutures or zinc oxide bandages

0

0

0

— Vaseline gauze

0

0

0

2.3. Instruments

— Instrument box made of suitable material

0

0

0

— Scissors

0

0

0

— Dissecting forceps

0

0

0

— Haemostatic clamps

0

0

0

2.4. Examination and monitoring equipment

0

0

0

— Disposable tongue depressors

0

0

0

— Medical evacuation sheets

0

0

0

— Stethoscope

0

0

0

— Sphygmomanometer

0

0

0

— Medical thermometer

0

0

0

— Hypothermic thermometer

0

0

0

—Quick malaria test, carriage shall be dependent upon operational area

0

0

0

2.5.
  Equipment for injection, perfusion, puncture and catheterisation

0

0

0

— Intravenous infusion set

0

0

0

— Disposable syringes and needles

0

0

0

2.6.
  General medical equipment

0

0

0

— Personal protective medical and nursing equipment

0

0

0

2.7.
  Immobilisation and setting equipment

0

0

0

— Set of splints of different sizes for the extremities

0

0

0

— Collar for neck immobilisation

0

0

0

3. ANTIDOTES

3.1. General

0

0

0

3.2. Cardio-vascular

0

0

0

3.3. Gastro-intestinal system

0

0

0

3.4. Nervous system

0

0

0

3.5. Respiratory system

0

0

0

3.6. Anti-infective

0

0

0

3.7. For external use

0

0

0

3.8. Other

0

0

0

3.9. Necessary for the administration of oxygen (including maintenance requisites)

0

0

0

Venue and date: ...

Captain’s signature: ...

Authorisation by competent person or authority: ...

SECTION C

CATEGORY C VESSELS

I.   Details of the vessel

Name: ...

Flag: ...

Home port: ...

II.   Medical supplies

| | Quantities required | Quantities actually carried on board | Remarks (in particular, any expiry date) |
| --- | --- | --- | --- |
| 1. MEDICINE |
| 1.1. Cardiovascular | |
| (a) Anti-angina preparations | 0 | 0 | 0 |
| 1.2. Gastro-intestinal system | | | |
| (a) Anti-diarrhoeals | 0 | 0 | 0 |
| 1.3. Analgesics and anti-spasmodics | | | |
| (a) Analgesics, anti-pyretics and anti-inflammatory preparations | 0 | 0 | 0 |
| 1.4. Nervous system | | | |
| (c) Seasickness remedies | 0 | 0 | 0 |
| 1.5. Medicines for external use | | | |
| (a) Skin medicines | 0 | 0 | 0 |
| — Antiseptic solutions | 0 | 0 | 0 |
| — Burn preparations | 0 | 0 | 0 |
| (b) Eye medicines | 0 | 0 | 0 |
| — Saline solution for eyewash | 0 | 0 | 0 |
| 2. MEDICAL EQUIPMENT |
| 2.1. Dressing and suturing equipment |
| — Tourniquets | 0 | 0 | 0 |
| — Adhesive elastic bandage | 0 | 0 | 0 |
| — Sterile gauze compresses | 0 | 0 | 0 |
| — Disposable gloves | 0 | 0 | 0 |
| — Adhesive dressings | 0 | 0 | 0 |
| — Sterile compression bandages | 0 | 0 | 0 |
| — Adhesive sutures or zinc oxide bandages | 0 | 0 | 0 |
| 3. ANTIDOTES |
| 3.1. General | 0 | 0 | 0 |
| 3.2. Cardio-vascular | 0 | 0 | 0 |
| 3.3. Gastro-intestinal system | 0 | 0 | 0 |
| 3.4. Nervous system | 0 | 0 | 0 |
| 3.5. Respiratory system | 0 | 0 | 0 |
| 3.6. Anti-infective | 0 | 0 | 0 |
| 3.7. For external use | 0 | 0 | 0 |
| 3.8. Other | 0 | 0 | 0 |
| 3.9. Necessary for the administration of oxygen (including maintenance requisites) | 0 | 0 | 0 |

Quantities required

Quantities actually carried on board

Remarks (in particular, any expiry date)

1. MEDICINE

1.1. Cardiovascular

(a) Anti-angina preparations

0

0

0

1.2. Gastro-intestinal system

(a) Anti-diarrhoeals

0

0

0

1.3. Analgesics and anti-spasmodics

(a) Analgesics, anti-pyretics and anti-inflammatory preparations

0

0

0

1.4. Nervous system

(c) Seasickness remedies

0

0

0

1.5. Medicines for external use

(a) Skin medicines

0

0

0

— Antiseptic solutions

0

0

0

— Burn preparations

0

0

0

(b) Eye medicines

0

0

0

— Saline solution for eyewash

0

0

0

2. MEDICAL EQUIPMENT

2.1. Dressing and suturing equipment

— Tourniquets

0

0

0

— Adhesive elastic bandage

0

0

0

— Sterile gauze compresses

0

0

0

— Disposable gloves

0

0

0

— Adhesive dressings

0

0

0

— Sterile compression bandages

0

0

0

— Adhesive sutures or zinc oxide bandages

0

0

0

3. ANTIDOTES

3.1. General

0

0

0

3.2. Cardio-vascular

0

0

0

3.3. Gastro-intestinal system

0

0

0

3.4. Nervous system

0

0

0

3.5. Respiratory system

0

0

0

3.6. Anti-infective

0

0

0

3.7. For external use

0

0

0

3.8. Other

0

0

0

3.9. Necessary for the administration of oxygen (including maintenance requisites)

0

0

0

Venue and date: ...

Captain’s signature: ...

Authorisation by competent person or authority: ...

---

(1)  Under the conditions of use prescribed by national laws and/or practices

1

(2)  Under the conditions of use prescribed by national laws and/or practices.

2

(3)  Under the conditions of use prescribed by national laws and/or practices.

3

---

DECISIONS

| 31.10.2019 | EN | Official Journal of the European Union | L 279/98 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/98

---

COMMISSION IMPLEMENTING DECISION (EU) 2019/1835

of 30 October 2019

excluding from European Union financing certain expenditure incurred by the Member States under the European Agricultural Guarantee Fund (EAGF) and under the European Agricultural Fund for Rural Development (EAFRD)

(notified under document C(2019) 7815)

(Only the Bulgarian, Croatian, Czech, Dutch, English, French, German, Greek, Hungarian, Italian, Lithuanian, Maltese, Portuguese, Romanian, Slovak, Spanish and Swedish texts are authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular Article 52 thereof,

After consulting the Committee on the Agricultural Funds,

Whereas:

| (1) | In accordance with Article 52 of Regulation (EU) No 1306/2013 the Commission is to carry out the necessary verifications, communicate to the Member States the results of those verifications, take note of the comments of the Member States, initiate a bilateral discussion so that an agreement may be reached with the Member States in question, and formally communicate its conclusions to them. |
| --- | --- |

(1)

In accordance with Article 52 of Regulation (EU) No 1306/2013 the Commission is to carry out the necessary verifications, communicate to the Member States the results of those verifications, take note of the comments of the Member States, initiate a bilateral discussion so that an agreement may be reached with the Member States in question, and formally communicate its conclusions to them.

| (2) | The Member States have had an opportunity to request the launch of a conciliation procedure. That opportunity has been used in some cases and the reports issued on the outcome have been examined by the Commission. |
| --- | --- |

(2)

The Member States have had an opportunity to request the launch of a conciliation procedure. That opportunity has been used in some cases and the reports issued on the outcome have been examined by the Commission.

| (3) | In accordance with Regulation (EU) No 1306/2013, only agricultural expenditure which has been incurred in a way that has not infringed Union law may be financed. |
| --- | --- |

(3)

In accordance with Regulation (EU) No 1306/2013, only agricultural expenditure which has been incurred in a way that has not infringed Union law may be financed.

| (4) | In the light of the verifications carried out, the outcome of the bilateral discussions and the conciliation procedures, part of the expenditure declared by the Member States does not fulfil this requirement and cannot, therefore, be financed under the EAGF and the EAFRD. |
| --- | --- |

(4)

In the light of the verifications carried out, the outcome of the bilateral discussions and the conciliation procedures, part of the expenditure declared by the Member States does not fulfil this requirement and cannot, therefore, be financed under the EAGF and the EAFRD.

| (5) | The amounts that are not recognised as being chargeable to the EAGF and the EAFRD should be indicated. Those amounts do not relate to expenditure incurred more than 24 months before the Commission’s written notification of the results of the verifications to the Member States. |
| --- | --- |

(5)

The amounts that are not recognised as being chargeable to the EAGF and the EAFRD should be indicated. Those amounts do not relate to expenditure incurred more than 24 months before the Commission’s written notification of the results of the verifications to the Member States.

| (6) | The amounts excluded from Union financing by the present Decision should also take into account any reductions or suspensions in accordance with Article 41 of Regulation (EU) No 1306/2013 due to the fact that such reductions or suspensions are of a provisional nature and without prejudice to decisions taken pursuant to Articles 51 or 52 of that Regulation. |
| --- | --- |

(6)

The amounts excluded from Union financing by the present Decision should also take into account any reductions or suspensions in accordance with Article 41 of Regulation (EU) No 1306/2013 due to the fact that such reductions or suspensions are of a provisional nature and without prejudice to decisions taken pursuant to Articles 51 or 52 of that Regulation.

| (7) | As regards the cases covered by this decision, the assessment of the amounts to be excluded on grounds of non-compliance with Union law was notified by the Commission to the Member States in a summary report on the subject (2). |
| --- | --- |

(7)

As regards the cases covered by this decision, the assessment of the amounts to be excluded on grounds of non-compliance with Union law was notified by the Commission to the Member States in a summary report on the subject (2).

| (8) | This Decision is without prejudice to any financial conclusions that the Commission may draw from the judgments of the Court of Justice of the European Union in cases pending on 15 September 2019, |
| --- | --- |

(8)

This Decision is without prejudice to any financial conclusions that the Commission may draw from the judgments of the Court of Justice of the European Union in cases pending on 15 September 2019,

HAS ADOPTED THIS DECISION:

Article 1

The amounts set out in the Annex and related to expenditure incurred by the Member States’ accredited paying agencies and declared under the EAGF or the EAFRD shall be excluded from Union financing.

Article 2

This Decision is addressed to the Kingdom of Belgium, the Republic of Bulgaria, the Czech Republic, the Federal Republic of Germany, Ireland, the Kingdom of Spain, the French Republic, the Republic of Croatia, the Italian Republic, the Republic of Cyprus, the Republic of Lithuania, the Grand Duchy of Luxembourg, Hungary, the Republic of Malta, the Kingdom of the Netherlands, the Portuguese Republic, Romania, the Slovak Republic, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 30 October 2019.

For the Commission

Phil HOGAN

Member of the Commission

---

(1)  
  OJ L 347, 20.12.2013, p.549

1

(2)  Ares(2019)6542527

2

---

ANNEX

Decision: 61

Budget Item: 0 5 0 7 0 1 0 7

| Member State | Measure | FY | Reason | Type | Correction % | Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ES | Fruit and Vegetables - Operational Programmes | 2009 | Reimbursement following judgment in case T-237/17 | FLAT RATE | 10,00 % | EUR | 3 922 888,80 | 204 258,51 | 1 880 130,29 |
| | Fruit and Vegetables - Operational Programmes | 2010 | Reimbursement following judgment in case T-237/17 | FLAT RATE | 10,00 % | EUR | 4 917 485,69 | 2 566 722,82 | 2 350 762,87 |
| | Fruit and Vegetables - Operational Programmes | 2011 | Reimbursement following judgment in case T-237/17 | FLAT RATE | 10,00 % | EUR | 440 969,18 | 220 484,59 | 220 484,59 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 1,59 % | EUR | 122 921,79 | 0,00 | 122 921,79 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,58 % | EUR | 8 144 125,58 | 0,00 | 8 144 125,58 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,80 % | EUR | 1 383 647,93 | 0,00 | 1 383 647,93 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 4,46 % | EUR | 3 642 817,36 | 0,00 | 3 642 817,36 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 4,99 % | EUR | 375 612,88 | 0,00 | 375 612,88 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,86 % | EUR | 9 260 920,72 | 0,00 | 9 260 920,72 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 6,40 % | EUR | 677 367,04 | 0,00 | 677 367,04 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 6,52 % | EUR | 1 126 563,99 | 0,00 | 1 126 563,99 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 7,68 % | EUR | 773 889,45 | 0,00 | 773 889,45 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,60 % | EUR | 608 889,90 | 0,00 | 608 889,90 |
| | Decoupled Direct Aids | 2011 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 10,04 % | EUR | 15 628 447,21 | 0,00 | 15 628 447,21 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 1,53 % | EUR | 107 658,06 | 0,00 | 107 658,06 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,52 % | EUR | 1 461 366,24 | 0,00 | 1 461 366,24 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,61 % | EUR | 8 152 425,60 | 0,00 | 8 152 425,60 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 4,40 % | EUR | 324 045,51 | 0,00 | 324 045,51 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 4,41 % | EUR | 3 250 342,68 | 0,00 | 3 250 342,68 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,47 % | EUR | 8 971 740,91 | 0,00 | 8 971 740,91 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 6,42 % | EUR | 1 133 969,53 | 0,00 | 1 133 969,53 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 7,67 % | EUR | 758 779,44 | 0,00 | 758 779,44 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,71 % | EUR | 634 659,58 | 0,00 | 634 659,58 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,84 % | EUR | 817 979,54 | 0,00 | 817 979,54 |
| | Decoupled Direct Aids | 2012 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 10,06 % | EUR | 16 284 452,86 | 0,00 | 16 284 452,86 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 1,52 % | EUR | 233 815,98 | 0,00 | 233 815,98 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 2,73 % | EUR | 1 889 533,78 | 0,00 | 1 889 533,78 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,47 % | EUR | 286 966,22 | 0,00 | 286 966,22 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,60 % | EUR | 8 922 409,09 | 0,00 | 8 922 409,09 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 4,34 % | EUR | 3 595 030,51 | 0,00 | 3 595 030,51 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,23 % | EUR | 9 337 109,09 | 0,00 | 9 337 109,09 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,67 % | EUR | 1 253 352,06 | 0,00 | 1 253 352,06 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,11 % | EUR | 735 385,02 | 0,00 | 735 385,02 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,35 % | EUR | 976 720,07 | 0,00 | 976 720,07 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,47 % | EUR | 791 381,36 | 0,00 | 791 381,36 |
| | Decoupled Direct Aids | 2013 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 10,09 % | EUR | 16 273 380,81 | 0,00 | 16 273 380,81 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 1,78 % | EUR | 213 024,96 | 0,00 | 213 024,96 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 2,43 % | EUR | 1 257 733,69 | 0,00 | 1 257 733,69 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,58 % | EUR | 8 900 539,54 | 0,00 | 8 900 539,54 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 3,67 % | EUR | 163 452,06 | 0,00 | 163 452,06 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,22 % | EUR | 13 137 895,99 | 0,00 | 13 137 895,99 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 5,62 % | EUR | 1 224 032,81 | 0,00 | 1 224 032,81 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,21 % | EUR | 1 097 274,61 | 0,00 | 1 097 274,61 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,22 % | EUR | 747 321,72 | 0,00 | 747 321,72 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 8,53 % | EUR | 1 000 460,40 | 0,00 | 1 000 460,40 |
| | Decoupled Direct Aids | 2014 | Reimbursement following judgment in case T-459/16 | FLAT RATE | 10,09 % | EUR | 16 483 871,52 | 0,00 | 16 483 871,52 |
| | | | | | Total ES: | EUR | 181 444 658,76 | 4 829 965,92 | 176 614 692,84 |

Member State

Measure

FY

Reason

Type

Correction %

Currency

Amount

Deductions

Financial Impact

ES

Fruit and Vegetables - Operational Programmes

2009

Reimbursement following judgment in case T-237/17

FLAT RATE

10,00 %

EUR

3 922 888,80

204 258,51

1 880 130,29

Fruit and Vegetables - Operational Programmes

2010

Reimbursement following judgment in case T-237/17

FLAT RATE

10,00 %

EUR

4 917 485,69

2 566 722,82

2 350 762,87

Fruit and Vegetables - Operational Programmes

2011

Reimbursement following judgment in case T-237/17

FLAT RATE

10,00 %

EUR

440 969,18

220 484,59

220 484,59

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

1,59 %

EUR

122 921,79

0,00

122 921,79

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

3,58 %

EUR

8 144 125,58

0,00

8 144 125,58

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

3,80 %

EUR

1 383 647,93

0,00

1 383 647,93

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

4,46 %

EUR

3 642 817,36

0,00

3 642 817,36

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

4,99 %

EUR

375 612,88

0,00

375 612,88

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

5,86 %

EUR

9 260 920,72

0,00

9 260 920,72

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

6,40 %

EUR

677 367,04

0,00

677 367,04

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

6,52 %

EUR

1 126 563,99

0,00

1 126 563,99

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

7,68 %

EUR

773 889,45

0,00

773 889,45

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

8,60 %

EUR

608 889,90

0,00

608 889,90

Decoupled Direct Aids

2011

Reimbursement following judgment in case T-459/16

FLAT RATE

10,04 %

EUR

15 628 447,21

0,00

15 628 447,21

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

1,53 %

EUR

107 658,06

0,00

107 658,06

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

3,52 %

EUR

1 461 366,24

0,00

1 461 366,24

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

3,61 %

EUR

8 152 425,60

0,00

8 152 425,60

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

4,40 %

EUR

324 045,51

0,00

324 045,51

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

4,41 %

EUR

3 250 342,68

0,00

3 250 342,68

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

5,47 %

EUR

8 971 740,91

0,00

8 971 740,91

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

6,42 %

EUR

1 133 969,53

0,00

1 133 969,53

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

7,67 %

EUR

758 779,44

0,00

758 779,44

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

8,71 %

EUR

634 659,58

0,00

634 659,58

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

8,84 %

EUR

817 979,54

0,00

817 979,54

Decoupled Direct Aids

2012

Reimbursement following judgment in case T-459/16

FLAT RATE

10,06 %

EUR

16 284 452,86

0,00

16 284 452,86

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

1,52 %

EUR

233 815,98

0,00

233 815,98

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

2,73 %

EUR

1 889 533,78

0,00

1 889 533,78

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

3,47 %

EUR

286 966,22

0,00

286 966,22

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

3,60 %

EUR

8 922 409,09

0,00

8 922 409,09

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

4,34 %

EUR

3 595 030,51

0,00

3 595 030,51

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

5,23 %

EUR

9 337 109,09

0,00

9 337 109,09

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

5,67 %

EUR

1 253 352,06

0,00

1 253 352,06

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

8,11 %

EUR

735 385,02

0,00

735 385,02

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

8,35 %

EUR

976 720,07

0,00

976 720,07

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

8,47 %

EUR

791 381,36

0,00

791 381,36

Decoupled Direct Aids

2013

Reimbursement following judgment in case T-459/16

FLAT RATE

10,09 %

EUR

16 273 380,81

0,00

16 273 380,81

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

1,78 %

EUR

213 024,96

0,00

213 024,96

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

2,43 %

EUR

1 257 733,69

0,00

1 257 733,69

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

3,58 %

EUR

8 900 539,54

0,00

8 900 539,54

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

3,67 %

EUR

163 452,06

0,00

163 452,06

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

5,22 %

EUR

13 137 895,99

0,00

13 137 895,99

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

5,62 %

EUR

1 224 032,81

0,00

1 224 032,81

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

8,21 %

EUR

1 097 274,61

0,00

1 097 274,61

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

8,22 %

EUR

747 321,72

0,00

747 321,72

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

8,53 %

EUR

1 000 460,40

0,00

1 000 460,40

Decoupled Direct Aids

2014

Reimbursement following judgment in case T-459/16

FLAT RATE

10,09 %

EUR

16 483 871,52

0,00

16 483 871,52

Total ES:

EUR

181 444 658,76

4 829 965,92

176 614 692,84

| Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- |
| EUR | 181 444 658,76 | 4 829 965,92 | 176 614 692,84 |

Currency

Amount

Deductions

Financial Impact

EUR

181 444 658,76

4 829 965,92

176 614 692,84

Budget Item: 6 7 0 1

| Member State | Measure | FY | Reason | Type | Correction % | Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| BE | Clearance of Accounts - Financial Clearance | 2017 | administrative error (p.105 du CB report) | ONE OFF | | EUR | - 497,41 | 0,00 | - 497,41 |
| | Clearance of Accounts - Financial Clearance | 2017 | over estimation on expenditure (prg. 5.3.4 of CB report) | ONE OFF | | EUR | - 597,14 | 0,00 | - 597,14 |
| | School Fruit Scheme | 2017 | School Scheme for SPW (Service Public Wallonie) | ONE OFF | | EUR | - 76 658,15 | 0,00 | - 76 658,15 |
| | | | | | Total BE: | EUR | - 77 752,70 | 0,00 | - 77 752,70 |
| BG | Cross-compliance | 2016 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | -1 006 053,47 | - 465,49 | -1 005 587,98 |
| | Cross-compliance | 2017 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | - 1 943,57 | 0,00 | - 1 943,57 |
| | Cross-compliance | 2018 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | - 86,08 | 0,00 | - 86,08 |
| | Cross-compliance | 2015 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 13 495,90 | 0,00 | - 13 495,90 |
| | Cross-compliance | 2016 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 1 392,60 | - 5,43 | - 1 387,17 |
| | Cross-compliance | 2017 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 1 108 875,35 | 0,00 | -1 108 875,35 |
| | Cross-compliance | 2018 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 2 508,66 | 0,00 | - 2 508,66 |
| | Other Direct Aids | 2018 | Insufficient level of OTSC | ONE OFF | | EUR | - 69 316,19 | 0,00 | - 69 316,19 |
| | Voluntary Coupled Support | 2018 | Insufficient level of OTSC | ONE OFF | | EUR | - 143 052,20 | 0,00 | - 143 052,20 |
| | Fruit and Vegetables - Exceptional support measures | 2015 | Reimbursement due to double recovery of reductions FY 2015 | ONE OFF | | EUR | 6 590,91 | 0,00 | 690,91 |
| | | | | | Total BG: | EUR | -2 340 133,11 | - 470,92 | -2 339 662,19 |
| CY | Voluntary Coupled Support | 2017 | Weak on-the-spot check - minimum control rate not reached - claim year 2016 - measure 1 | ONE OFF | | EUR | - 45 645,68 | 0,00 | - 45 645,68 |
| | Voluntary Coupled Support | 2017 | Weak on-the-spot check - minimum control rate not reached - claim year 2016 - measure 3 | ONE OFF | | EUR | - 11 476,64 | 0,00 | - 11 476,64 |
| | | | | | Total CY: | EUR | - 57 122,32 | 0,00 | - 57 122,32 |
| CZ | School Fruit Scheme | 2016 | Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2016 and FY2017 | FLAT RATE | 5,00 % | EUR | - 189 042,66 | 0,00 | - 189 042,66 |
| | School Fruit Scheme | 2017 | Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2016 and FY2017 | FLAT RATE | 5,00 % | EUR | - 195 157,27 | 0,00 | - 195 157,27 |
| | School Fruit Scheme | 2018 | Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2018 | FLAT RATE | 5,00 % | EUR | - 18 547,93 | 0,00 | - 18 547,93 |
| | | | | | Total CZ: | EUR | - 402 747,86 | 0,00 | - 402 747,86 |
| DE | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | Actions not implemented - OP 2015 | ONE OFF | | EUR | - 18 715,44 | 0,00 | - 18 715,44 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2017 | Actions not implemented OP 2016 | ONE OFF | | EUR | - 114,70 | 0,00 | - 114,70 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | Carry over - ineligible amount FY 2016 | ONE OFF | | EUR | - 62 468,92 | 0,00 | - 62 468,92 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2017 | Carry over - ineligible expenditure FY 2017 | ONE OFF | | EUR | - 2 593,24 | 0,00 | - 2 593,24 |
| | Irregularities | 2017 | compliance testing and substantive testing of Annexes II and III and known errors (annual sanctions) | ONE OFF | | EUR | - 70 522,63 | 0,00 | - 70 522,63 |
| | Certification | 2017 | Differences in debts' reconciliation EAGF | ONE OFF | | EUR | - 32 117,63 | 0,00 | - 32 117,63 |
| | Clearance of Accounts - Financial Clearance | 2017 | Financial errors found in substantive testing on EAGF (annex 1 of CB report) | ONE OFF | | EUR | - 205,77 | 0,00 | - 205,77 |
| | Certification | 2017 | Individual errors in EAGF | ONE OFF | | EUR | - 347 912,42 | 0,00 | - 347 912,42 |
| | | | | | Total DE: | EUR | - 534 650,75 | 0,00 | - 534 650,75 |
| ES | Wine - Investment | 2015 | Absence of checks on the soundness of estimates FY 2015 | FLAT RATE | 10,00 % | EUR | - 91 783,15 | 0,00 | - 91 783,15 |
| | Wine - Investment | 2016 | Absence of checks on the soundness of estimates FY 2016 | FLAT RATE | 10,00 % | EUR | - 143 195,41 | 0,00 | - 143 195,41 |
| | Wine - Investment | 2017 | Absence of checks on the soundness of estimates FY 2017 | FLAT RATE | 10,00 % | EUR | - 83 928,98 | 0,00 | - 83 928,98 |
| | Wine - Investment | 2015 | Actions paid not included in Support Applicatoin - FY 2015 | ONE OFF | | EUR | - 179 674,57 | 0,00 | - 179 674,57 |
| | Wine - Investment | 2016 | Actions paid not included in Support Applicatoin - FY 2016 | ONE OFF | | EUR | - 477 034,00 | 0,00 | - 477 034,00 |
| | Wine - Investment | 2015 | Deficiency control of replacement of barrels | FLAT RATE | 5,00 % | EUR | - 20 659,11 | 0,00 | - 20 659,11 |
| | Wine - Investment | 2016 | Deficiency in control replacement barrels FY 2016 | FLAT RATE | 5,00 % | EUR | - 58 234,92 | 0,00 | - 58 234,92 |
| | | | | | Total ES: | EUR | -1 054 510,14 | 0,00 | -1 054 510,14 |
| FR | Irregularities | 2015 | Application de sanction en cas d'intentionnalité | ONE OFF | | EUR | -1 915 954,75 | - 353 235,44 | -1 562 719,31 |
| | Irregularities | 2016 | Application de sanction en cas d'intentionnalité | ONE OFF | | EUR | -1 793 774,28 | - 469 942,73 | -1 323 831,55 |
| | Irregularities | 2017 | Application de sanction en cas d'intentionnalité | ONE OFF | | EUR | -1 435 446,92 | 0,00 | -1 435 446,92 |
| | Other Direct Aid - POSEI (2014+) | 2016 | Contrôles administratifs exhaustifs insuffisants FY2016 | FLAT RATE | 5,00 % | EUR | - 400 907,21 | - 44 784,16 | - 356 123,05 |
| | Other Direct Aid - POSEI (2014+) | 2017 | Contrôles administratifs exhaustifs insuffisants FY2017 | FLAT RATE | 5,00 % | EUR | - 448 715,16 | 0,00 | - 448 715,16 |
| | Other Direct Aid - POSEI (2014+) | 2018 | Contrôles administratifs exhaustifs insuffisants FY2018 | FLAT RATE | 5,00 % | EUR | - 453 373,17 | 0,00 | - 453 373,17 |
| | Wine - Promotion on third country markets | 2015 | Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis. | FLAT RATE | 7,00 % | EUR | - 177 746,45 | 0,00 | - 177 746,45 |
| | Wine - Promotion on third country markets | 2016 | Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis. | FLAT RATE | 7,00 % | EUR | - 205 303,65 | - 54 653,76 | - 150 649,89 |
| | Wine - Promotion on third country markets | 2017 | Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis. | FLAT RATE | 7,00 % | EUR | - 32 754,65 | 0,00 | - 32 754,65 |
| | | | | | Total FR: | EUR | -6 863 976,24 | - 922 616,09 | -5 941 360,15 |
| GB | Entitlements | 2016 | BPS calculation not finalised/notified - impact on BPS 2015 | ONE OFF | | EUR | - 72 690,20 | - 416,38 | - 72 273,82 |
| | Entitlements | 2017 | BPS calculation not finalised/notified - impact on BPS 2016 | ONE OFF | | EUR | - 125 141,46 | - 746,55 | - 124 394,91 |
| | Decoupled Direct Aids | 2016 | BPS calculation not finalised/notified - impact on greening 2015 | ONE OFF | | EUR | - 34 726,50 | - 334,36 | - 34 392,14 |
| | Decoupled Direct Aids | 2017 | BPS calculation not finalised/notified - impact on greening 2016 | ONE OFF | | EUR | - 53 070,85 | - 507,58 | - 52 563,27 |
| | Decoupled Direct Aids | 2016 | BPS calculation not finalised/notified - impact on YF 2015 | ONE OFF | | EUR | - 621,92 | - 3,56 | - 618,36 |
| | Decoupled Direct Aids | 2017 | BPS calculation not finalised/notified - impact on YF 2016 | ONE OFF | | EUR | - 105,86 | - 0,63 | - 105,23 |
| | Entitlements | 2016 | Checks of the active farmer status - impact on BPS 2015 | ONE OFF | | EUR | - 30 199,79 | - 172,99 | - 30 026,80 |
| | Entitlements | 2017 | Checks of the active farmer status - impact on BPS 2016 | ONE OFF | | EUR | - 110 341,24 | - 658,26 | - 109 682,98 |
| | Entitlements | 2018 | Checks of the active farmer status - impact on BPS 2017 | FLAT RATE | 2,00 % | EUR | - 53 909,19 | 0,00 | - 53 909,19 |
| | Decoupled Direct Aids | 2016 | Checks of the active farmer status - impact on greening 2015 | ONE OFF | | EUR | - 13 142,45 | - 126,54 | - 13 015,91 |
| | Decoupled Direct Aids | 2017 | Checks of the active farmer status - impact on greening 2016 | ONE OFF | | EUR | - 46 208,88 | - 441,95 | - 45 766,93 |
| | Decoupled Direct Aids | 2018 | Checks of the active farmer status - impact on greening 2017 | FLAT RATE | 2,00 % | EUR | - 22 855,89 | 0,00 | - 22 855,89 |
| | Decoupled Direct Aids | 2016 | Checks of the active farmer status - impact on YF 2015 | ONE OFF | | EUR | - 107,06 | - 0,61 | - 106,45 |
| | Decoupled Direct Aids | 2017 | Checks of the active farmer status - impact on YF 2016 | ONE OFF | | EUR | - 294,97 | - 1,76 | - 293,21 |
| | Decoupled Direct Aids | 2018 | Checks of the active farmer status - impact on YF 2017 | FLAT RATE | 2,00 % | EUR | - 44,17 | 0,00 | - 44,17 |
| | Entitlements | 2016 | Checks on the establishment of PE - impact on BPS 2015 | ONE OFF | | EUR | - 23 659,93 | - 135,53 | - 23 524,40 |
| | Entitlements | 2017 | Checks on the establishment of PE - impact on BPS 2016 | ONE OFF | | EUR | - 24 133,52 | - 143,97 | - 23 989,55 |
| | Entitlements | 2018 | Checks on the establishment of PE - impact on BPS 2017 | ONE OFF | | EUR | - 24 851,63 | 0,00 | - 24 851,63 |
| | Decoupled Direct Aids | 2016 | Checks on the establishment of PE - impact on greening 2015 | ONE OFF | | EUR | - 10 490,85 | - 101,01 | - 10 389,84 |
| | Decoupled Direct Aids | 2017 | Checks on the establishment of PE - impact on greening 2016 | ONE OFF | | EUR | - 10 700,16 | - 102,34 | - 10 597,82 |
| | Decoupled Direct Aids | 2018 | Checks on the establishment of PE - impact on greening 2017 | ONE OFF | | EUR | - 10 697,48 | 0,00 | - 10 697,48 |
| | Entitlements | 2017 | Weakness in the definition of Active Farmer- connected companies (BPS) | ONE OFF | | EUR | -1 028 190,68 | 0,00 | -1 028 190,68 |
| | Decoupled Direct Aids | 2017 | Weakness in the definition of Active Farmer- connected companies (Greening) | ONE OFF | | EUR | - 560 949,25 | 0,00 | - 560 949,25 |
| | Voluntary Coupled Support | 2017 | Weakness in the definition of Active Farmer- connected companies (VCS01) | ONE OFF | | EUR | - 40 185,21 | 0,00 | - 40 185,21 |
| | Voluntary Coupled Support | 2017 | Weakness in the definition of Active Farmer- connected companies (VCS02) | ONE OFF | | EUR | - 8 468,96 | 0,00 | - 8 468,96 |
| | Voluntary Coupled Support | 2017 | Weakness in the definition of Active Farmer- connected companies (VCS03) | ONE OFF | | EUR | - 96 566,25 | 0,00 | - 96 566,25 |
| | Decoupled Direct Aids | 2017 | Weakness in the definition of Active Farmer- connected companies (YFS) | ONE OFF | | EUR | - 3 447,83 | 0,00 | - 3 447,83 |
| | | | | | Total GB: | EUR | -2 405 802,18 | - 3 894,02 | -240 908,16 |
| HR | Decoupled Direct Aids | 2017 | Incorrect calculation of administrative penalties | ONE OFF | | EUR | - 84 324,37 | 0,00 | - 84 324,37 |
| | Decoupled Direct Aids | 2016 | Minimum control rate for on-the-spot checks not reached | ONE OFF | | EUR | - 35 671,36 | 0,00 | - 35 671,36 |
| | Decoupled Direct Aids | 2017 | Minimum control rate for on-the-spot checks not reached | ONE OFF | | EUR | - 35 671,36 | 0,00 | - 35 671,36 |
| | Decoupled Direct Aids | 2018 | Minimum control rate for on-the-spot checks not reached | ONE OFF | | EUR | - 35 671,36 | 0,00 | - 35 671,36 |
| | Decoupled Direct Aids | 2016 | Weak check of the recovery of payment entitlements | ONE OFF | | EUR | - 325,70 | 0,00 | - 325,70 |
| | Decoupled Direct Aids | 2017 | Weak check of the recovery of payment entitlements | ONE OFF | | EUR | - 580,06 | 0,00 | - 580,06 |
| | Decoupled Direct Aids | 2016 | Weak check of the status of the farmer (National Reserve) | ONE OFF | | EUR | - 8 016,98 | 0,00 | - 8 016,98 |
| | Decoupled Direct Aids | 2017 | Weak check of the status of the farmer (National Reserve) | ONE OFF | | EUR | - 7 212,34 | 0,00 | - 7 212,34 |
| | Decoupled Direct Aids | 2016 | Weak check of the status of the farmer (YFS) | ONE OFF | | EUR | - 18 828,55 | 0,00 | - 18 828,55 |
| | Decoupled Direct Aids | 2017 | Weak check of the status of the farmer (YFS) | ONE OFF | | EUR | - 25 056,29 | 0,00 | - 25 056,29 |
| | Decoupled Direct Aids | 2016 | Weak check of the value of payment entitlements | ONE OFF | | EUR | - 37 401,73 | 0,00 | - 37 401,73 |
| | Decoupled Direct Aids | 2017 | Weak check of the value of payment entitlements | ONE OFF | | EUR | - 103 179,76 | 0,00 | - 103 179,76 |
| | Decoupled Direct Aids | 2017 | Weak check on landscape features | ONE OFF | | EUR | - 11 057,33 | 0,00 | - 11 057,33 |
| | Decoupled Direct Aids | 2018 | Weak check on landscape features | ONE OFF | | EUR | - 4 390,01 | 0,00 | - 4 390,01 |
| | Decoupled Direct Aids | 2018 | Weak check on organic farmers | ONE OFF | | EUR | - 3 480,59 | 0,00 | - 3 480,59 |
| | Decoupled Direct Aids | 2016 | Weak check on permanent grassland | ONE OFF | | EUR | - 1 445,37 | 0,00 | - 13 445,37 |
| | Decoupled Direct Aids | 2017 | Weak check on permanent grassland | ONE OFF | | EUR | - 5 470,77 | 0,00 | - 5 470,77 |
| | Decoupled Direct Aids | 2018 | Weak check on permanent grassland | ONE OFF | | EUR | - 4 819,93 | 0,00 | - 4 819,93 |
| | Decoupled Direct Aids | 2016 | Weak check on retroactive recovery | ONE OFF | | EUR | - 485 129,84 | 0,00 | - 485 129,84 |
| | Decoupled Direct Aids | 2017 | Weak check on retroactive recovery | ONE OFF | | EUR | - 277 225,31 | 0,00 | - 277 225,31 |
| | Decoupled Direct Aids | 2018 | Weak check on retroactive recovery | ONE OFF | | EUR | - 16 508,26 | 0,00 | - 16 508,26 |
| | | | | | Total HR: | EUR | -1 213 467,27 | 0,00 | -1 213 467,27 |
| HU | Decoupled Direct Aids | 2016 | OTSC level insufficient | ONE OFF | | EUR | - 484 117,64 | 0,00 | - 484 117,64 |
| | Decoupled Direct Aids | 2016 | OTSC quality EFA incorrectly identified | ONE OFF | | EUR | - 11 871,24 | 0,00 | - 11 871,24 |
| | Decoupled Direct Aids | 2017 | OTSC quality EFA incorrectly identified | ONE OFF | | EUR | - 2 572,84 | 0,00 | - 2 572,84 |
| | | | | | Total HU: | EUR | - 498 561,72 | 0,00 | - 498 561,72 |
| IE | Decoupled Direct Aids | 2016 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | -1 132 326,70 | 0,00 | -1 132 326,70 |
| | Decoupled Direct Aids | 2017 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | -1 089 743,91 | 0,00 | -1 089 743,91 |
| | Decoupled Direct Aids | 2018 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | - 633 104,48 | 0,00 | - 633 104,48 |
| | | | | | Total IE: | EUR | -2 855 175,09 | 0,00 | -2 855 175,09 |
| IT | Decoupled Direct Aids | 2016 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | -68 685 227,76 | - 166 676,14 | -68 518 551,62 |
| | Voluntary Coupled Support Area Based | 2016 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | -3 690 568,93 | - 262,10 | -3 690 306,83 |
| | Decoupled Direct Aids | 2017 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | -65 482 175,39 | - 5 116,81 | -65 477 058,61 |
| | Reimbursement of direct aids in relation to financial discipline | 2017 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | - 754 110,44 | - 1,21 | - 754 109,23 |
| | Voluntary Coupled Support | 2017 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | -3 811 472,84 | - 0,27 | -3 811 472,58 |
| | Decoupled Direct Aids | 2018 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | - 830 757,67 | - 127,68 | - 830 629,95 |
| | Reimbursement of direct aids in relation to financial discipline | 2018 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | - 730 282,20 | 0,00 | - 730 282,20 |
| | Voluntary Coupled Support | 2018 | Comprehensive correction for all findings | FLAT RATE | 2,00 % | EUR | - 111 868,12 | 0,00 | - 111 868,12 |
| | Cross-compliance | 2016 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 208 203,54 | 0,00 | - 208 203,54 |
| | Cross-compliance | 2017 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 4 103,38 | 0,00 | - 4 103,38 |
| | Cross-compliance | 2018 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 3 627,62 | 0,00 | - 3 627,62 |
| | Cross-compliance | 2017 | Deficient I&R checks under SMR 7 - CY 2016 | FLAT RATE | 2,00 % | EUR | - 315 751,97 | 0,00 | - 315 751,97 |
| | Cross-compliance | 2018 | Deficient I&R checks under SMR 7 - CY 2016 | FLAT RATE | 2,00 % | EUR | - 10 223,00 | 0,00 | - 10 223,00 |
| | Certification | 2017 | Known errors in the EAGF | ONE OFF | | EUR | - 4 834,89 | 0,00 | - 4 834,89 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2014 | OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | -1 015 887,56 | 0,00 | -1 015 887,56 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2015 | OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 4 241,09 | 0,00 | - 4 241,09 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 1 110,78 | 0,00 | - 1 110,78 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2014 | OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 170 533,71 | 0,00 | - 170 533,71 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2015 | OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | -2 522 983,06 | 0,00 | -2 522 983,06 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 18 839,14 | 0,00 | - 18 839,14 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2017 | OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | 3 889,40 | 0,00 | 3 889,40 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2015 | OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 933 283,90 | 0,00 | - 933 283,90 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | -2 963 312,69 | 0,00 | -2 963 312,69 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2017 | OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 3 941,19 | 0,00 | - 3 941,19 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2016 | OP 2016 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | - 649 642,58 | 0,00 | - 649 642,58 |
| | Fruit and Vegetables - Operational programmes incl withdrawals | 2017 | OP 2016 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations | FLAT RATE | 5,00 % | EUR | -2 770 183,74 | 0,00 | -2 770 183,74 |
| | | | | | Total IT: | EUR | -155 693 277,79 | - 172 184,21 | -155 521 093,58 |
| LU | Decoupled Direct Aids | 2016 | Weak check on landscape features - CY2015 - BPS | ONE OFF | | EUR | - 4 732,24 | - 11,14 | - 4 721,10 |
| | Decoupled Direct Aids | 2016 | Weak check on landscape features - CY2015 - greening | ONE OFF | | EUR | - 3 798,16 | - 8,94 | - 3 789,22 |
| | Decoupled Direct Aids | 2017 | Weak check on landscape features - CY2016 - BPS | ONE OFF | | EUR | - 4 732,24 | 0,00 | - 4 732,24 |
| | Decoupled Direct Aids | 2017 | Weak check on landscape features - CY2016 - greening | ONE OFF | | EUR | - 2 604,22 | 0,00 | - 2 604,22 |
| | Decoupled Direct Aids | 2018 | Weak check on landscape features - CY2017 -BPS | ONE OFF | | EUR | - 4 732,25 | 0,00 | - 4 732,25 |
| | Decoupled Direct Aids | 2018 | Weak check on landscape features - CY2017 - greening | ONE OFF | | EUR | - 19 678,14 | 0,00 | - 19 678,14 |
| | Decoupled Direct Aids | 2016 | Weak check on permanent grassland - CY2015 - BPS | ONE OFF | | EUR | - 13 828,00 | - 32,57 | - 13 795,43 |
| | Decoupled Direct Aids | 2016 | Weak check on permanent grassland - CY2015 - greening | ONE OFF | | EUR | - 9 378,34 | - 22,09 | - 9 356,25 |
| | Decoupled Direct Aids | 2017 | Weaknesses in the on-the-spot checks - CY2016 - BPS | ONE OFF | | EUR | - 11 228,50 | 0,00 | - 11 228,50 |
| | Decoupled Direct Aids | 2017 | Weaknesses in the on-the-spot checks - CY2016 - greening | ONE OFF | | EUR | - 5 175,15 | 0,00 | - 5 175,15 |
| | Decoupled Direct Aids | 2018 | Weaknesses in the on-the-spot checks - CY2017 -BPS | ONE OFF | | EUR | - 9 785,03 | 0,00 | - 9 785,03 |
| | Decoupled Direct Aids | 2018 | Weaknesses in the on-the-spot checks - CY2017 - greening | ONE OFF | | EUR | - 4 021,65 | 0,00 | - 4 021,65 |
| | | | | | Total LU: | EUR | - 93 693,92 | - 74,74 | - 93 619,18 |
| MT | Voluntary Coupled Support | 2016 | VCS 1.4 - CY 2015 | ONE OFF | | EUR | - 33 498,88 | - 712,48 | - 32 786,40 |
| | Voluntary Coupled Support | 2017 | VCS 1.4 - CY 2015 | ONE OFF | | EUR | - 384,46 | - 47,09 | - 337,37 |
| | Voluntary Coupled Support | 2017 | VCS 1.4 - CY 2016 | ONE OFF | | EUR | - 25 238,90 | - 902,82 | - 24 336,08 |
| | Voluntary Coupled Support | 2018 | VCS 1.4 - CY 2017 | ONE OFF | | EUR | - 2 306,34 | - 824,30 | - 1 482,04 |
| | Voluntary Coupled Support | 2016 | VCS 1.5-1.6 - CY 2015 | FLAT RATE | 3,00 % | EUR | - 57 676,21 | - 88,01 | - 57 588,20 |
| | Voluntary Coupled Support | 2017 | VCS 1.5-1.6 - CY 2016 | FLAT RATE | 3,00 % | EUR | - 60 919,52 | - 185,76 | - 60 733,76 |
| | Voluntary Coupled Support | 2018 | VCS 1.5-1.6 - CY 2017 | FLAT RATE | 3,00 % | EUR | - 61 345,33 | - 41,35 | - 61 303,98 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 but not SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 3 035,82 | 0,00 | - 3 035,82 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 2 797,27 | 0,00 | - 2 797,27 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 2 853,82 | - 71,68 | - 2 782,14 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 and SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 966,76 | 0,00 | - 966,76 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 1 104,65 | 0,00 | - 1 104,65 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 1 186,87 | 0,00 | - 1 186,87 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 8 only - No evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 430,66 | 0,00 | - 430,66 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 423,66 | - 0,91 | - 422,75 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 412,07 | - 0,12 | - 411,95 |
| | | | | | Total MT: | EUR | - 254 581,22 | - 2 874,52 | - 251 706,70 |
| NL | Entitlements | 2016 | Deficiency regarding active farmer status - impact on BPS | ONE OFF | | EUR | -2 627 743,09 | 0,00 | -2 627 743,09 |
| | Entitlements | 2017 | Deficiency regarding active farmer status - impact on BPS | ONE OFF | | EUR | - 113 182,27 | 0,00 | - 113 182,27 |
| | Decoupled Direct Aids | 2016 | Deficiency regarding active farmer status - impact on Greening | ONE OFF | | EUR | -1 154 421,24 | 0,00 | -1 154 421,24 |
| | Decoupled Direct Aids | 2017 | Deficiency regarding active farmer status - impact on Greening | ONE OFF | | EUR | - 46 449,89 | 0,00 | - 46 449,89 |
| | Cross Compliance - Recoveries | 2016 | Deficiency regarding active farmer status - impact on Recoveries | ONE OFF | | EUR | 559,36 | 0,00 | 559,36 |
| | Irregularities | 2016 | Deficiency regarding active farmer status - impact on Recoveries | ONE OFF | | EUR | 9 603,85 | 0,00 | 9 603,85 |
| | Voluntary Coupled Support | 2016 | Deficiency regarding active farmer status - impact on VCS | ONE OFF | | EUR | - 66 023,74 | 0,00 | - 66 023,74 |
| | Decoupled Direct Aids | 2016 | Deficiency regarding active farmer status - impact on YF | ONE OFF | | EUR | - 11 566,93 | 0,00 | - 11 566,93 |
| | Decoupled Direct Aids | 2017 | Insufficent control rate | ONE OFF | | EUR | - 39 998,52 | 0,00 | - 39 998,52 |
| | Decoupled Direct Aids | 2018 | LPIS and other weaknesses | ONE OFF | | EUR | - 166 919,54 | 0,00 | - 166 919,54 |
| | Temporary and exceptional support measures | 2016 | Recovery of undue payments R. 2015/1853 (Article 1) | ONE OFF | | EUR | -2 515 000,00 | 0,00 | -2 515 000,00 |
| | Decoupled Direct Aids | 2017 | Weaknesses in retroactive recoveries | ONE OFF | | EUR | - 1 888,98 | 0,00 | - 1 888,98 |
| | Decoupled Direct Aids | 2016 | Weaknesses in the LPIS | ONE OFF | | EUR | - 10 405,19 | 0,00 | - 10 405,19 |
| | Decoupled Direct Aids | 2017 | Weaknesses in the LPIS | ONE OFF | | EUR | - 15 624,74 | 0,00 | - 15 624,74 |
| | Decoupled Direct Aids | 2016 | Weaknesses in the LPIS | ONE OFF | | EUR | - 5 202,60 | 0,00 | - 5 202,60 |
| | Decoupled Direct Aids | 2016 | Weaknesses in the OTSC - check of maintenance | ONE OFF | | EUR | - 28 396,88 | 0,00 | - 28 396,88 |
| | Decoupled Direct Aids | 2017 | Weaknesses in the OTSC - check of maintenance | ONE OFF | | EUR | - 50 082,79 | 0,00 | - 50 082,79 |
| | Decoupled Direct Aids | 2016 | Weaknesses in the OTSC - remote sensing | ONE OFF | | EUR | - 32 382,33 | 0,00 | - 32 382,33 |
| | Decoupled Direct Aids | 2017 | Weaknesses in the OTSC - remote sensing | ONE OFF | | EUR | - 62 115,67 | 0,00 | - 62 115,67 |
| | Voluntary Coupled Support | 2018 | Weaknesses in the set-up and control of Bovine premia | ONE OFF | | EUR | - 242 859,95 | 0,00 | - 242 859,95 |
| | Voluntary Coupled Support | 2016 | Weaknesses in the set-up and control of Bovine premia | ONE OFF | | EUR | - 292 314,10 | 0,00 | - 292 314,10 |
| | Voluntary Coupled Support | 2017 | Weaknesses in the set-up and control of Bovine premia | ONE OFF | | EUR | - 203 767,61 | 0,00 | - 203 767,61 |
| | Voluntary Coupled Support | 2018 | Weaknesses in the set-up and control of Ovine premia | ONE OFF | | EUR | - 311 190,35 | 0,00 | - 311 190,35 |
| | Voluntary Coupled Support | 2016 | Weaknesses in the set-up and control of Ovine premia | ONE OFF | | EUR | - 245 664,73 | 0,00 | - 245 664,73 |
| | Voluntary Coupled Support | 2017 | Weaknesses in the set-up and control of Ovine premia | ONE OFF | | EUR | - 216 663,18 | 0,00 | - 216 663,18 |
| | Decoupled Direct Aids | 2018 | Weaknesses in VCS animals - effect on allocation of entitlements on BPS, Greening and young farmer scheme payments | ONE OFF | | EUR | - 732 338,89 | 0,00 | - 732 338,89 |
| | Decoupled Direct Aids | 2016 | Weaknesses in VCS animals - effect on allocation of entitlements on BPS payments | ONE OFF | | EUR | - 167 677,35 | 0,00 | - 167 677,35 |
| | Decoupled Direct Aids | 2017 | Weaknesses in VCS animals - effect on allocation of entitlements on BPS payments | ONE OFF | | EUR | - 335 906,85 | 0,00 | - 335 906,85 |
| | Decoupled Direct Aids | 2016 | Weaknesses in VCS animals - effect on allocation of entitlements on greening payments | ONE OFF | | EUR | - 72 621,06 | 0,00 | - 72 621,06 |
| | Decoupled Direct Aids | 2017 | Weaknesses in VCS animals - effect on allocation of entitlements on greening payments | ONE OFF | | EUR | - 145 212,53 | 0,00 | - 145 212,53 |
| | Decoupled Direct Aids | 2016 | Weaknesses in VCS animals - effect on allocation of entitlements on young farmer scheme payments | ONE OFF | | EUR | - 24 208,33 | 0,00 | - 24 208,33 |
| | Decoupled Direct Aids | 2017 | Weaknesses in VCS animals - effect on allocation of entitlements on young farmer scheme payments | ONE OFF | | EUR | - 23 805,29 | 0,00 | - 23 805,29 |
| | | | | | Total NL: | EUR | -9 951 471,41 | 0,00 | -9 951 471,41 |
| RO | Certification | 2016 | Known errors in the EAGF | ONE OFF | | EUR | - 76,27 | 0,00 | - 76,27 |
| | Certification | 2016 | MLE in the EAGF | ESTIMATED BY AMOUNT | | EUR | -17 323 228,52 | - 440,82 | -17 322 787,70 |
| | | | | | Total RO: | EUR | -17 323 304,79 | - 440,82 | -17 322 863,97 |
| SE | Voluntary Coupled Support | 2017 | Weakness in the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY2016 | FLAT RATE | 3,00 % | EUR | -2 618 729,82 | - 5 697,92 | -2 613 031,90 |
| | Voluntary Coupled Support | 2018 | Weakness in the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY2017 | FLAT RATE | 3,00 % | EUR | -2 610 686,25 | 0,00 | -2 610 686,25 |
| | Voluntary Coupled Support | 2016 | Weakness in the key control in respect of administrative checks to establish the eligibility of the aid- correctness of the final payment CY2015 for VCS | ONE OFF | | EUR | - 862 615,07 | 0,00 | - 862 615,07 |
| | Entitlements | 2017 | Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016 | ESTIMATED BY PERCENTAGE | 0,58 % | EUR | - 96 196,72 | - 3 374,63 | - 92 822,09 |
| | Greening Payment | 2017 | Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016 | ESTIMATED BY PERCENTAGE | 0,58 % | EUR | - 51 533,13 | - 47 356,10 | - 4 177,03 |
| | Voluntary Coupled Support | 2017 | Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016 | ESTIMATED BY PERCENTAGE | 0,58 % | EUR | - 29 660,36 | 0,00 | - 29 660,36 |
| | Young farmers scheme | 2017 | Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016 | ESTIMATED BY PERCENTAGE | 0,58 % | EUR | - 2 826,93 | 0,00 | - 2 826,93 |
| | Voluntary Coupled Support | 2016 | Weakness in the the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY 2015 | FLAT RATE | 3,00 % | EUR | -2 560 986,85 | - 25 878,45 | -2 535 108,40 |
| | Voluntary Coupled Support | 2017 | Weakness in the the key control in respect of administrative checks to establish the eligibility of the aid- correctness of the final payment CY2016 for VCS | ONE OFF | | EUR | - 160 270,35 | 0,00 | - 160 270,35 |
| | | | | | Total SE: | EUR | -8 993 505,48 | - 82 307,10 | -8 911 198,38 |

Member State

Measure

FY

Reason

Type

Correction %

Currency

Amount

Deductions

Financial Impact

BE

Clearance of Accounts - Financial Clearance

2017

administrative error (p.105 du CB report)

ONE OFF

EUR

- 497,41

0,00

- 497,41

Clearance of Accounts - Financial Clearance

2017

over estimation on expenditure (prg. 5.3.4 of CB report)

ONE OFF

EUR

- 597,14

0,00

- 597,14

School Fruit Scheme

2017

School Scheme for SPW (Service Public Wallonie)

ONE OFF

EUR

- 76 658,15

0,00

- 76 658,15

Total BE:

EUR

- 77 752,70

0,00

- 77 752,70

BG

Cross-compliance

2016

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

-1 006 053,47

- 465,49

-1 005 587,98

Cross-compliance

2017

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

- 1 943,57

0,00

- 1 943,57

Cross-compliance

2018

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

- 86,08

0,00

- 86,08

Cross-compliance

2015

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 13 495,90

0,00

- 13 495,90

Cross-compliance

2016

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 1 392,60

- 5,43

- 1 387,17

Cross-compliance

2017

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 1 108 875,35

0,00

-1 108 875,35

Cross-compliance

2018

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 2 508,66

0,00

- 2 508,66

Other Direct Aids

2018

Insufficient level of OTSC

ONE OFF

EUR

- 69 316,19

0,00

- 69 316,19

Voluntary Coupled Support

2018

Insufficient level of OTSC

ONE OFF

EUR

- 143 052,20

0,00

- 143 052,20

Fruit and Vegetables - Exceptional support measures

2015

Reimbursement due to double recovery of reductions FY 2015

ONE OFF

EUR

6 590,91

0,00

690,91

Total BG:

EUR

-2 340 133,11

- 470,92

-2 339 662,19

CY

Voluntary Coupled Support

2017

Weak on-the-spot check - minimum control rate not reached - claim year 2016 - measure 1

ONE OFF

EUR

- 45 645,68

0,00

- 45 645,68

Voluntary Coupled Support

2017

Weak on-the-spot check - minimum control rate not reached - claim year 2016 - measure 3

ONE OFF

EUR

- 11 476,64

0,00

- 11 476,64

Total CY:

EUR

- 57 122,32

0,00

- 57 122,32

CZ

School Fruit Scheme

2016

Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2016 and FY2017

FLAT RATE

5,00 %

EUR

- 189 042,66

0,00

- 189 042,66

School Fruit Scheme

2017

Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2016 and FY2017

FLAT RATE

5,00 %

EUR

- 195 157,27

0,00

- 195 157,27

School Fruit Scheme

2018

Deficiencies in key control ‘Performance of on-the-spot checks of sufficient quality’ FY2018

FLAT RATE

5,00 %

EUR

- 18 547,93

0,00

- 18 547,93

Total CZ:

EUR

- 402 747,86

0,00

- 402 747,86

DE

Fruit and Vegetables - Operational programmes incl withdrawals

2016

Actions not implemented - OP 2015

ONE OFF

EUR

- 18 715,44

0,00

- 18 715,44

Fruit and Vegetables - Operational programmes incl withdrawals

2017

Actions not implemented OP 2016

ONE OFF

EUR

- 114,70

0,00

- 114,70

Fruit and Vegetables - Operational programmes incl withdrawals

2016

Carry over - ineligible amount FY 2016

ONE OFF

EUR

- 62 468,92

0,00

- 62 468,92

Fruit and Vegetables - Operational programmes incl withdrawals

2017

Carry over - ineligible expenditure FY 2017

ONE OFF

EUR

- 2 593,24

0,00

- 2 593,24

Irregularities

2017

compliance testing and substantive testing of Annexes II and III and known errors (annual sanctions)

ONE OFF

EUR

- 70 522,63

0,00

- 70 522,63

Certification

2017

Differences in debts' reconciliation EAGF

ONE OFF

EUR

- 32 117,63

0,00

- 32 117,63

Clearance of Accounts - Financial Clearance

2017

Financial errors found in substantive testing on EAGF (annex 1 of CB report)

ONE OFF

EUR

- 205,77

0,00

- 205,77

Certification

2017

Individual errors in EAGF

ONE OFF

EUR

- 347 912,42

0,00

- 347 912,42

Total DE:

EUR

- 534 650,75

0,00

- 534 650,75

ES

Wine - Investment

2015

Absence of checks on the soundness of estimates FY 2015

FLAT RATE

10,00 %

EUR

- 91 783,15

0,00

- 91 783,15

Wine - Investment

2016

Absence of checks on the soundness of estimates FY 2016

FLAT RATE

10,00 %

EUR

- 143 195,41

0,00

- 143 195,41

Wine - Investment

2017

Absence of checks on the soundness of estimates FY 2017

FLAT RATE

10,00 %

EUR

- 83 928,98

0,00

- 83 928,98

Wine - Investment

2015

Actions paid not included in Support Applicatoin - FY 2015

ONE OFF

EUR

- 179 674,57

0,00

- 179 674,57

Wine - Investment

2016

Actions paid not included in Support Applicatoin - FY 2016

ONE OFF

EUR

- 477 034,00

0,00

- 477 034,00

Wine - Investment

2015

Deficiency control of replacement of barrels

FLAT RATE

5,00 %

EUR

- 20 659,11

0,00

- 20 659,11

Wine - Investment

2016

Deficiency in control replacement barrels FY 2016

FLAT RATE

5,00 %

EUR

- 58 234,92

0,00

- 58 234,92

Total ES:

EUR

-1 054 510,14

0,00

-1 054 510,14

FR

Irregularities

2015

Application de sanction en cas d'intentionnalité

ONE OFF

EUR

-1 915 954,75

- 353 235,44

-1 562 719,31

Irregularities

2016

Application de sanction en cas d'intentionnalité

ONE OFF

EUR

-1 793 774,28

- 469 942,73

-1 323 831,55

Irregularities

2017

Application de sanction en cas d'intentionnalité

ONE OFF

EUR

-1 435 446,92

0,00

-1 435 446,92

Other Direct Aid - POSEI (2014+)

2016

Contrôles administratifs exhaustifs insuffisants FY2016

FLAT RATE

5,00 %

EUR

- 400 907,21

- 44 784,16

- 356 123,05

Other Direct Aid - POSEI (2014+)

2017

Contrôles administratifs exhaustifs insuffisants FY2017

FLAT RATE

5,00 %

EUR

- 448 715,16

0,00

- 448 715,16

Other Direct Aid - POSEI (2014+)

2018

Contrôles administratifs exhaustifs insuffisants FY2018

FLAT RATE

5,00 %

EUR

- 453 373,17

0,00

- 453 373,17

Wine - Promotion on third country markets

2015

Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis.

FLAT RATE

7,00 %

EUR

- 177 746,45

0,00

- 177 746,45

Wine - Promotion on third country markets

2016

Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis.

FLAT RATE

7,00 %

EUR

- 205 303,65

- 54 653,76

- 150 649,89

Wine - Promotion on third country markets

2017

Weakness in key controls on administrative checks and on OTSC. Absence of risk analysis.

FLAT RATE

7,00 %

EUR

- 32 754,65

0,00

- 32 754,65

Total FR:

EUR

-6 863 976,24

- 922 616,09

-5 941 360,15

GB

Entitlements

2016

BPS calculation not finalised/notified - impact on BPS 2015

ONE OFF

EUR

- 72 690,20

- 416,38

- 72 273,82

Entitlements

2017

BPS calculation not finalised/notified - impact on BPS 2016

ONE OFF

EUR

- 125 141,46

- 746,55

- 124 394,91

Decoupled Direct Aids

2016

BPS calculation not finalised/notified - impact on greening 2015

ONE OFF

EUR

- 34 726,50

- 334,36

- 34 392,14

Decoupled Direct Aids

2017

BPS calculation not finalised/notified - impact on greening 2016

ONE OFF

EUR

- 53 070,85

- 507,58

- 52 563,27

Decoupled Direct Aids

2016

BPS calculation not finalised/notified - impact on YF 2015

ONE OFF

EUR

- 621,92

- 3,56

- 618,36

Decoupled Direct Aids

2017

BPS calculation not finalised/notified - impact on YF 2016

ONE OFF

EUR

- 105,86

- 0,63

- 105,23

Entitlements

2016

Checks of the active farmer status - impact on BPS 2015

ONE OFF

EUR

- 30 199,79

- 172,99

- 30 026,80

Entitlements

2017

Checks of the active farmer status - impact on BPS 2016

ONE OFF

EUR

- 110 341,24

- 658,26

- 109 682,98

Entitlements

2018

Checks of the active farmer status - impact on BPS 2017

FLAT RATE

2,00 %

EUR

- 53 909,19

0,00

- 53 909,19

Decoupled Direct Aids

2016

Checks of the active farmer status - impact on greening 2015

ONE OFF

EUR

- 13 142,45

- 126,54

- 13 015,91

Decoupled Direct Aids

2017

Checks of the active farmer status - impact on greening 2016

ONE OFF

EUR

- 46 208,88

- 441,95

- 45 766,93

Decoupled Direct Aids

2018

Checks of the active farmer status - impact on greening 2017

FLAT RATE

2,00 %

EUR

- 22 855,89

0,00

- 22 855,89

Decoupled Direct Aids

2016

Checks of the active farmer status - impact on YF 2015

ONE OFF

EUR

- 107,06

- 0,61

- 106,45

Decoupled Direct Aids

2017

Checks of the active farmer status - impact on YF 2016

ONE OFF

EUR

- 294,97

- 1,76

- 293,21

Decoupled Direct Aids

2018

Checks of the active farmer status - impact on YF 2017

FLAT RATE

2,00 %

EUR

- 44,17

0,00

- 44,17

Entitlements

2016

Checks on the establishment of PE - impact on BPS 2015

ONE OFF

EUR

- 23 659,93

- 135,53

- 23 524,40

Entitlements

2017

Checks on the establishment of PE - impact on BPS 2016

ONE OFF

EUR

- 24 133,52

- 143,97

- 23 989,55

Entitlements

2018

Checks on the establishment of PE - impact on BPS 2017

ONE OFF

EUR

- 24 851,63

0,00

- 24 851,63

Decoupled Direct Aids

2016

Checks on the establishment of PE - impact on greening 2015

ONE OFF

EUR

- 10 490,85

- 101,01

- 10 389,84

Decoupled Direct Aids

2017

Checks on the establishment of PE - impact on greening 2016

ONE OFF

EUR

- 10 700,16

- 102,34

- 10 597,82

Decoupled Direct Aids

2018

Checks on the establishment of PE - impact on greening 2017

ONE OFF

EUR

- 10 697,48

0,00

- 10 697,48

Entitlements

2017

Weakness in the definition of Active Farmer- connected companies (BPS)

ONE OFF

EUR

-1 028 190,68

0,00

-1 028 190,68

Decoupled Direct Aids

2017

Weakness in the definition of Active Farmer- connected companies (Greening)

ONE OFF

EUR

- 560 949,25

0,00

- 560 949,25

Voluntary Coupled Support

2017

Weakness in the definition of Active Farmer- connected companies (VCS01)

ONE OFF

EUR

- 40 185,21

0,00

- 40 185,21

Voluntary Coupled Support

2017

Weakness in the definition of Active Farmer- connected companies (VCS02)

ONE OFF

EUR

- 8 468,96

0,00

- 8 468,96

Voluntary Coupled Support

2017

Weakness in the definition of Active Farmer- connected companies (VCS03)

ONE OFF

EUR

- 96 566,25

0,00

- 96 566,25

Decoupled Direct Aids

2017

Weakness in the definition of Active Farmer- connected companies (YFS)

ONE OFF

EUR

- 3 447,83

0,00

- 3 447,83

Total GB:

EUR

-2 405 802,18

- 3 894,02

-240 908,16

HR

Decoupled Direct Aids

2017

Incorrect calculation of administrative penalties

ONE OFF

EUR

- 84 324,37

0,00

- 84 324,37

Decoupled Direct Aids

2016

Minimum control rate for on-the-spot checks not reached

ONE OFF

EUR

- 35 671,36

0,00

- 35 671,36

Decoupled Direct Aids

2017

Minimum control rate for on-the-spot checks not reached

ONE OFF

EUR

- 35 671,36

0,00

- 35 671,36

Decoupled Direct Aids

2018

Minimum control rate for on-the-spot checks not reached

ONE OFF

EUR

- 35 671,36

0,00

- 35 671,36

Decoupled Direct Aids

2016

Weak check of the recovery of payment entitlements

ONE OFF

EUR

- 325,70

0,00

- 325,70

Decoupled Direct Aids

2017

Weak check of the recovery of payment entitlements

ONE OFF

EUR

- 580,06

0,00

- 580,06

Decoupled Direct Aids

2016

Weak check of the status of the farmer (National Reserve)

ONE OFF

EUR

- 8 016,98

0,00

- 8 016,98

Decoupled Direct Aids

2017

Weak check of the status of the farmer (National Reserve)

ONE OFF

EUR

- 7 212,34

0,00

- 7 212,34

Decoupled Direct Aids

2016

Weak check of the status of the farmer (YFS)

ONE OFF

EUR

- 18 828,55

0,00

- 18 828,55

Decoupled Direct Aids

2017

Weak check of the status of the farmer (YFS)

ONE OFF

EUR

- 25 056,29

0,00

- 25 056,29

Decoupled Direct Aids

2016

Weak check of the value of payment entitlements

ONE OFF

EUR

- 37 401,73

0,00

- 37 401,73

Decoupled Direct Aids

2017

Weak check of the value of payment entitlements

ONE OFF

EUR

- 103 179,76

0,00

- 103 179,76

Decoupled Direct Aids

2017

Weak check on landscape features

ONE OFF

EUR

- 11 057,33

0,00

- 11 057,33

Decoupled Direct Aids

2018

Weak check on landscape features

ONE OFF

EUR

- 4 390,01

0,00

- 4 390,01

Decoupled Direct Aids

2018

Weak check on organic farmers

ONE OFF

EUR

- 3 480,59

0,00

- 3 480,59

Decoupled Direct Aids

2016

Weak check on permanent grassland

ONE OFF

EUR

- 1 445,37

0,00

- 13 445,37

Decoupled Direct Aids

2017

Weak check on permanent grassland

ONE OFF

EUR

- 5 470,77

0,00

- 5 470,77

Decoupled Direct Aids

2018

Weak check on permanent grassland

ONE OFF

EUR

- 4 819,93

0,00

- 4 819,93

Decoupled Direct Aids

2016

Weak check on retroactive recovery

ONE OFF

EUR

- 485 129,84

0,00

- 485 129,84

Decoupled Direct Aids

2017

Weak check on retroactive recovery

ONE OFF

EUR

- 277 225,31

0,00

- 277 225,31

Decoupled Direct Aids

2018

Weak check on retroactive recovery

ONE OFF

EUR

- 16 508,26

0,00

- 16 508,26

Total HR:

EUR

-1 213 467,27

0,00

-1 213 467,27

HU

Decoupled Direct Aids

2016

OTSC level insufficient

ONE OFF

EUR

- 484 117,64

0,00

- 484 117,64

Decoupled Direct Aids

2016

OTSC quality EFA incorrectly identified

ONE OFF

EUR

- 11 871,24

0,00

- 11 871,24

Decoupled Direct Aids

2017

OTSC quality EFA incorrectly identified

ONE OFF

EUR

- 2 572,84

0,00

- 2 572,84

Total HU:

EUR

- 498 561,72

0,00

- 498 561,72

IE

Decoupled Direct Aids

2016

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

-1 132 326,70

0,00

-1 132 326,70

Decoupled Direct Aids

2017

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

-1 089 743,91

0,00

-1 089 743,91

Decoupled Direct Aids

2018

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

- 633 104,48

0,00

- 633 104,48

Total IE:

EUR

-2 855 175,09

0,00

-2 855 175,09

IT

Decoupled Direct Aids

2016

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

-68 685 227,76

- 166 676,14

-68 518 551,62

Voluntary Coupled Support Area Based

2016

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

-3 690 568,93

- 262,10

-3 690 306,83

Decoupled Direct Aids

2017

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

-65 482 175,39

- 5 116,81

-65 477 058,61

Reimbursement of direct aids in relation to financial discipline

2017

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

- 754 110,44

- 1,21

- 754 109,23

Voluntary Coupled Support

2017

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

-3 811 472,84

- 0,27

-3 811 472,58

Decoupled Direct Aids

2018

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

- 830 757,67

- 127,68

- 830 629,95

Reimbursement of direct aids in relation to financial discipline

2018

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

- 730 282,20

0,00

- 730 282,20

Voluntary Coupled Support

2018

Comprehensive correction for all findings

FLAT RATE

2,00 %

EUR

- 111 868,12

0,00

- 111 868,12

Cross-compliance

2016

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 208 203,54

0,00

- 208 203,54

Cross-compliance

2017

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 4 103,38

0,00

- 4 103,38

Cross-compliance

2018

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 3 627,62

0,00

- 3 627,62

Cross-compliance

2017

Deficient I&R checks under SMR 7 - CY 2016

FLAT RATE

2,00 %

EUR

- 315 751,97

0,00

- 315 751,97

Cross-compliance

2018

Deficient I&R checks under SMR 7 - CY 2016

FLAT RATE

2,00 %

EUR

- 10 223,00

0,00

- 10 223,00

Certification

2017

Known errors in the EAGF

ONE OFF

EUR

- 4 834,89

0,00

- 4 834,89

Fruit and Vegetables - Operational programmes incl withdrawals

2014

OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

-1 015 887,56

0,00

-1 015 887,56

Fruit and Vegetables - Operational programmes incl withdrawals

2015

OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 4 241,09

0,00

- 4 241,09

Fruit and Vegetables - Operational programmes incl withdrawals

2016

OP 2013 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 1 110,78

0,00

- 1 110,78

Fruit and Vegetables - Operational programmes incl withdrawals

2014

OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 170 533,71

0,00

- 170 533,71

Fruit and Vegetables - Operational programmes incl withdrawals

2015

OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

-2 522 983,06

0,00

-2 522 983,06

Fruit and Vegetables - Operational programmes incl withdrawals

2016

OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 18 839,14

0,00

- 18 839,14

Fruit and Vegetables - Operational programmes incl withdrawals

2017

OP 2014 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

3 889,40

0,00

3 889,40

Fruit and Vegetables - Operational programmes incl withdrawals

2015

OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 933 283,90

0,00

- 933 283,90

Fruit and Vegetables - Operational programmes incl withdrawals

2016

OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

-2 963 312,69

0,00

-2 963 312,69

Fruit and Vegetables - Operational programmes incl withdrawals

2017

OP 2015 -FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 3 941,19

0,00

- 3 941,19

Fruit and Vegetables - Operational programmes incl withdrawals

2016

OP 2016 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

- 649 642,58

0,00

- 649 642,58

Fruit and Vegetables - Operational programmes incl withdrawals

2017

OP 2016 - FV/2016/002/IT; shortcomings in F&V sector under the scheme of the Operational Programmes and recognition of Producer Organisations

FLAT RATE

5,00 %

EUR

-2 770 183,74

0,00

-2 770 183,74

Total IT:

EUR

-155 693 277,79

- 172 184,21

-155 521 093,58

LU

Decoupled Direct Aids

2016

Weak check on landscape features - CY2015 - BPS

ONE OFF

EUR

- 4 732,24

- 11,14

- 4 721,10

Decoupled Direct Aids

2016

Weak check on landscape features - CY2015 - greening

ONE OFF

EUR

- 3 798,16

- 8,94

- 3 789,22

Decoupled Direct Aids

2017

Weak check on landscape features - CY2016 - BPS

ONE OFF

EUR

- 4 732,24

0,00

- 4 732,24

Decoupled Direct Aids

2017

Weak check on landscape features - CY2016 - greening

ONE OFF

EUR

- 2 604,22

0,00

- 2 604,22

Decoupled Direct Aids

2018

Weak check on landscape features - CY2017 -BPS

ONE OFF

EUR

- 4 732,25

0,00

- 4 732,25

Decoupled Direct Aids

2018

Weak check on landscape features - CY2017 - greening

ONE OFF

EUR

- 19 678,14

0,00

- 19 678,14

Decoupled Direct Aids

2016

Weak check on permanent grassland - CY2015 - BPS

ONE OFF

EUR

- 13 828,00

- 32,57

- 13 795,43

Decoupled Direct Aids

2016

Weak check on permanent grassland - CY2015 - greening

ONE OFF

EUR

- 9 378,34

- 22,09

- 9 356,25

Decoupled Direct Aids

2017

Weaknesses in the on-the-spot checks - CY2016 - BPS

ONE OFF

EUR

- 11 228,50

0,00

- 11 228,50

Decoupled Direct Aids

2017

Weaknesses in the on-the-spot checks - CY2016 - greening

ONE OFF

EUR

- 5 175,15

0,00

- 5 175,15

Decoupled Direct Aids

2018

Weaknesses in the on-the-spot checks - CY2017 -BPS

ONE OFF

EUR

- 9 785,03

0,00

- 9 785,03

Decoupled Direct Aids

2018

Weaknesses in the on-the-spot checks - CY2017 - greening

ONE OFF

EUR

- 4 021,65

0,00

- 4 021,65

Total LU:

EUR

- 93 693,92

- 74,74

- 93 619,18

MT

Voluntary Coupled Support

2016

VCS 1.4 - CY 2015

ONE OFF

EUR

- 33 498,88

- 712,48

- 32 786,40

Voluntary Coupled Support

2017

VCS 1.4 - CY 2015

ONE OFF

EUR

- 384,46

- 47,09

- 337,37

Voluntary Coupled Support

2017

VCS 1.4 - CY 2016

ONE OFF

EUR

- 25 238,90

- 902,82

- 24 336,08

Voluntary Coupled Support

2018

VCS 1.4 - CY 2017

ONE OFF

EUR

- 2 306,34

- 824,30

- 1 482,04

Voluntary Coupled Support

2016

VCS 1.5-1.6 - CY 2015

FLAT RATE

3,00 %

EUR

- 57 676,21

- 88,01

- 57 588,20

Voluntary Coupled Support

2017

VCS 1.5-1.6 - CY 2016

FLAT RATE

3,00 %

EUR

- 60 919,52

- 185,76

- 60 733,76

Voluntary Coupled Support

2018

VCS 1.5-1.6 - CY 2017

FLAT RATE

3,00 %

EUR

- 61 345,33

- 41,35

- 61 303,98

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 but not SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 3 035,82

0,00

- 3 035,82

Cross-compliance

2017

CY 2016 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 2 797,27

0,00

- 2 797,27

Cross-compliance

2018

CY 2017 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 2 853,82

- 71,68

- 2 782,14

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 and SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 966,76

0,00

- 966,76

Cross-compliance

2017

CY 2016 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 1 104,65

0,00

- 1 104,65

Cross-compliance

2018

CY 2017 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 1 186,87

0,00

- 1 186,87

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 8 only - No evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 430,66

0,00

- 430,66

Cross-compliance

2017

CY 2016 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 423,66

- 0,91

- 422,75

Cross-compliance

2018

CY 2017 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 412,07

- 0,12

- 411,95

Total MT:

EUR

- 254 581,22

- 2 874,52

- 251 706,70

NL

Entitlements

2016

Deficiency regarding active farmer status - impact on BPS

ONE OFF

EUR

-2 627 743,09

0,00

-2 627 743,09

Entitlements

2017

Deficiency regarding active farmer status - impact on BPS

ONE OFF

EUR

- 113 182,27

0,00

- 113 182,27

Decoupled Direct Aids

2016

Deficiency regarding active farmer status - impact on Greening

ONE OFF

EUR

-1 154 421,24

0,00

-1 154 421,24

Decoupled Direct Aids

2017

Deficiency regarding active farmer status - impact on Greening

ONE OFF

EUR

- 46 449,89

0,00

- 46 449,89

Cross Compliance - Recoveries

2016

Deficiency regarding active farmer status - impact on Recoveries

ONE OFF

EUR

559,36

0,00

559,36

Irregularities

2016

Deficiency regarding active farmer status - impact on Recoveries

ONE OFF

EUR

9 603,85

0,00

9 603,85

Voluntary Coupled Support

2016

Deficiency regarding active farmer status - impact on VCS

ONE OFF

EUR

- 66 023,74

0,00

- 66 023,74

Decoupled Direct Aids

2016

Deficiency regarding active farmer status - impact on YF

ONE OFF

EUR

- 11 566,93

0,00

- 11 566,93

Decoupled Direct Aids

2017

Insufficent control rate

ONE OFF

EUR

- 39 998,52

0,00

- 39 998,52

Decoupled Direct Aids

2018

LPIS and other weaknesses

ONE OFF

EUR

- 166 919,54

0,00

- 166 919,54

Temporary and exceptional support measures

2016

Recovery of undue payments R. 2015/1853 (Article 1)

ONE OFF

EUR

-2 515 000,00

0,00

-2 515 000,00

Decoupled Direct Aids

2017

Weaknesses in retroactive recoveries

ONE OFF

EUR

- 1 888,98

0,00

- 1 888,98

Decoupled Direct Aids

2016

Weaknesses in the LPIS

ONE OFF

EUR

- 10 405,19

0,00

- 10 405,19

Decoupled Direct Aids

2017

Weaknesses in the LPIS

ONE OFF

EUR

- 15 624,74

0,00

- 15 624,74

Decoupled Direct Aids

2016

Weaknesses in the LPIS

ONE OFF

EUR

- 5 202,60

0,00

- 5 202,60

Decoupled Direct Aids

2016

Weaknesses in the OTSC - check of maintenance

ONE OFF

EUR

- 28 396,88

0,00

- 28 396,88

Decoupled Direct Aids

2017

Weaknesses in the OTSC - check of maintenance

ONE OFF

EUR

- 50 082,79

0,00

- 50 082,79

Decoupled Direct Aids

2016

Weaknesses in the OTSC - remote sensing

ONE OFF

EUR

- 32 382,33

0,00

- 32 382,33

Decoupled Direct Aids

2017

Weaknesses in the OTSC - remote sensing

ONE OFF

EUR

- 62 115,67

0,00

- 62 115,67

Voluntary Coupled Support

2018

Weaknesses in the set-up and control of Bovine premia

ONE OFF

EUR

- 242 859,95

0,00

- 242 859,95

Voluntary Coupled Support

2016

Weaknesses in the set-up and control of Bovine premia

ONE OFF

EUR

- 292 314,10

0,00

- 292 314,10

Voluntary Coupled Support

2017

Weaknesses in the set-up and control of Bovine premia

ONE OFF

EUR

- 203 767,61

0,00

- 203 767,61

Voluntary Coupled Support

2018

Weaknesses in the set-up and control of Ovine premia

ONE OFF

EUR

- 311 190,35

0,00

- 311 190,35

Voluntary Coupled Support

2016

Weaknesses in the set-up and control of Ovine premia

ONE OFF

EUR

- 245 664,73

0,00

- 245 664,73

Voluntary Coupled Support

2017

Weaknesses in the set-up and control of Ovine premia

ONE OFF

EUR

- 216 663,18

0,00

- 216 663,18

Decoupled Direct Aids

2018

Weaknesses in VCS animals - effect on allocation of entitlements on BPS, Greening and young farmer scheme payments

ONE OFF

EUR

- 732 338,89

0,00

- 732 338,89

Decoupled Direct Aids

2016

Weaknesses in VCS animals - effect on allocation of entitlements on BPS payments

ONE OFF

EUR

- 167 677,35

0,00

- 167 677,35

Decoupled Direct Aids

2017

Weaknesses in VCS animals - effect on allocation of entitlements on BPS payments

ONE OFF

EUR

- 335 906,85

0,00

- 335 906,85

Decoupled Direct Aids

2016

Weaknesses in VCS animals - effect on allocation of entitlements on greening payments

ONE OFF

EUR

- 72 621,06

0,00

- 72 621,06

Decoupled Direct Aids

2017

Weaknesses in VCS animals - effect on allocation of entitlements on greening payments

ONE OFF

EUR

- 145 212,53

0,00

- 145 212,53

Decoupled Direct Aids

2016

Weaknesses in VCS animals - effect on allocation of entitlements on young farmer scheme payments

ONE OFF

EUR

- 24 208,33

0,00

- 24 208,33

Decoupled Direct Aids

2017

Weaknesses in VCS animals - effect on allocation of entitlements on young farmer scheme payments

ONE OFF

EUR

- 23 805,29

0,00

- 23 805,29

Total NL:

EUR

-9 951 471,41

0,00

-9 951 471,41

RO

Certification

2016

Known errors in the EAGF

ONE OFF

EUR

- 76,27

0,00

- 76,27

Certification

2016

MLE in the EAGF

ESTIMATED BY AMOUNT

EUR

-17 323 228,52

- 440,82

-17 322 787,70

Total RO:

EUR

-17 323 304,79

- 440,82

-17 322 863,97

SE

Voluntary Coupled Support

2017

Weakness in the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY2016

FLAT RATE

3,00 %

EUR

-2 618 729,82

- 5 697,92

-2 613 031,90

Voluntary Coupled Support

2018

Weakness in the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY2017

FLAT RATE

3,00 %

EUR

-2 610 686,25

0,00

-2 610 686,25

Voluntary Coupled Support

2016

Weakness in the key control in respect of administrative checks to establish the eligibility of the aid- correctness of the final payment CY2015 for VCS

ONE OFF

EUR

- 862 615,07

0,00

- 862 615,07

Entitlements

2017

Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016

ESTIMATED BY PERCENTAGE

0,58 %

EUR

- 96 196,72

- 3 374,63

- 92 822,09

Greening Payment

2017

Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016

ESTIMATED BY PERCENTAGE

0,58 %

EUR

- 51 533,13

- 47 356,10

- 4 177,03

Voluntary Coupled Support

2017

Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016

ESTIMATED BY PERCENTAGE

0,58 %

EUR

- 29 660,36

0,00

- 29 660,36

Young farmers scheme

2017

Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016

ESTIMATED BY PERCENTAGE

0,58 %

EUR

- 2 826,93

0,00

- 2 826,93

Voluntary Coupled Support

2016

Weakness in the the key control concerning the checks on the correctness of the aid calculation including the application of sanctions VCS CY 2015

FLAT RATE

3,00 %

EUR

-2 560 986,85

- 25 878,45

-2 535 108,40

Voluntary Coupled Support

2017

Weakness in the the key control in respect of administrative checks to establish the eligibility of the aid- correctness of the final payment CY2016 for VCS

ONE OFF

EUR

- 160 270,35

0,00

- 160 270,35

Total SE:

EUR

-8 993 505,48

- 82 307,10

-8 911 198,38

| Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- |
| EUR | -210 613 733,99 | -1 184 862,42 | -209 428 871,57 |

Currency

Amount

Deductions

Financial Impact

EUR

-210 613 733,99

-1 184 862,42

-209 428 871,57

Budget Item: 6711

| Member State | Measure | FY | Reason | Type | Correction % | Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| BE | Clearance of Accounts - Financial Clearance | 2017 | Substantial error on sampling (Annex 15 of CB report) | ONE OFF | | EUR | - 3 869,02 | 0,00 | - 3 869,02 |
| | Clearance of Accounts - Financial Clearance | 2017 | Substantial error on sampling (annex 14 of CB report) | ONE OFF | | EUR | - 205,57 | 0,00 | - 205,57 |
| | | | | | Total BE: | EUR | - 4 074,59 | 0,00 | - 4 074,59 |
| BG | Cross-compliance | 2016 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | - 223 326,63 | - 8 009,67 | - 215 316,96 |
| | Cross-compliance | 2017 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | - 834,40 | 0,00 | - 834,40 |
| | Cross-compliance | 2018 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015 | FLAT RATE | 5,00 % | EUR | - 293,61 | 0,00 | - 293,61 |
| | Cross-compliance | 2017 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 184 118,40 | - 688,70 | - 183 429,70 |
| | Cross-compliance | 2018 | Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016 | FLAT RATE | 5,00 % | EUR | - 8 204,10 | 0,00 | - 8 204,10 |
| | | | | | Total BG: | EUR | - 416 777,14 | - 8 698,37 | - 408 078,77 |
| CZ | Rural Development EAFRD measures subject to IACS | 2016 | M10: double financing | ONE OFF | | EUR | - 7 674,67 | 0,00 | - 7 674,67 |
| | Rural Development EAFRD measures subject to IACS | 2017 | M10: double financing | ONE OFF | | EUR | - 7 484,02 | 0,00 | - 7 484,02 |
| | Rural Development EAFRD measures subject to IACS | 2017 | M14: advance notification of on-the-spot checks - FY2017 | FLAT RATE | 5,00 % | EUR | - 14 191,54 | 0,00 | - 14 191,54 |
| | Rural Development EAFRD measures subject to IACS | 2018 | M14: advance notification of on-the-spot checks - FY2018 and FY2019 | FLAT RATE | 5,00 % | EUR | - 15 511,62 | 0,00 | - 15 511,62 |
| | Rural Development EAFRD measures subject to IACS | 2019 | M14: advance notification of on-the-spot checks - FY2018 and FY2019 | FLAT RATE | 5,00 % | EUR | - 5 405,86 | 0,00 | - 5 405,86 |
| | | | | | Total CZ: | EUR | - 50 267,71 | 0,00 | - 50 267,71 |
| DE | Certification | 2017 | Differences in debts' reconciliation EAFRD | ONE OFF | | EUR | - 9 497,41 | 0,00 | - 9 497,41 |
| | Rural Development EAFRD forestry measures | 2016 | Double-financing between M8 (first afforestation) and EFA greening - FY 2016. | ONE OFF | | EUR | - 10 543,25 | 0,00 | - 10 543,25 |
| | Rural Development EAFRD forestry measures | 2017 | Double-financing between M8 (first afforestation) and EFA greening - FY 2017. | ONE OFF | | EUR | - 8 997,06 | 0,00 | - 8 997,06 |
| | Rural Development EAFRD forestry measures | 2018 | Double-financing between M8 (first afforestation) and EFA greening - FY 2018. | ONE OFF | | EUR | - 8 919,87 | 0,00 | - 8 919,87 |
| | Clearance of Accounts - Financial Clearance | 2017 | Financial errors found in substantive testing on EAFRD (annexes 11, 7a, 7b) of CB report | ONE OFF | | EUR | - 35 267,33 | 0,00 | - 35 267,33 |
| | Certification | 2017 | Individual errors in EAFRD | ONE OFF | | EUR | - 7 618,01 | 0,00 | - 7 618,01 |
| | | | | | Total DE: | EUR | - 80 842,93 | 0,00 | - 80 842,93 |
| ES | Rural Development EAFRD investment - private beneficiaries | 2018 | M121: 5 % flat rate correction (transitional expenditure on M04 in FY2018) | FLAT RATE | 5,00 % | EUR | - 2 447,56 | 0,00 | - 2 447,56 |
| | Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013) | 2013 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2013) | FLAT RATE | 5,00 % | EUR | - 24 078,53 | 0,00 | - 24 078,53 |
| | Rural Development EAFRD Investment - private beneficiaries | 2014 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2014) | FLAT RATE | 5,00 % | EUR | - 29 716,69 | 0,00 | - 29 716,69 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2016) | FLAT RATE | 5,00 % | EUR | - 576 669,13 | 0,00 | - 576 669,13 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction. FYs 2016, 2017 [transitional expenditure on M06] | FLAT RATE | 5,00 % | EUR | - 23 343,35 | 0,00 | - 23 343,35 |
| | Rural Development EAFRD Measures with flat-rate support | 2017 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction. FYs 2016, 2017 [transitional expenditure on M06] | FLAT RATE | 5,00 % | EUR | - 3 889,09 | 0,00 | - 3 889,09 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1] | FLAT RATE | 5,00 % | EUR | - 35 782,98 | 0,00 | - 35 782,98 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1] | FLAT RATE | 5,00 % | EUR | - 58 528,57 | 0,00 | - 58 528,57 |
| | Rural Development EAFRD investment - private beneficiaries | 2017 | M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1] | FLAT RATE | 5,00 % | EUR | - 50 965,72 | 0,00 | - 50 965,72 |
| | Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013) | 2013 | M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FY: 2013) | FLAT RATE | 2,00 % | EUR | - 24 354,54 | 0,00 | - 24 354,54 |
| | Rural Development EAFRD Investment - private beneficiaries | 2014 | M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FY: 2014) | FLAT RATE | 2,00 % | EUR | - 6 109,94 | 0,00 | - 6 109,94 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FYs: 2015-2016-2017) | FLAT RATE | 2,00 % | EUR | - 267 943,18 | 0,00 | - 267 943,18 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FYs: 2015-2016-2017) | FLAT RATE | 2,00 % | EUR | - 315 906,15 | 0,00 | - 315 906,15 |
| | | | | | Total ES: | EUR | -1 419 735,43 | 0,00 | -1 419 735,43 |
| FR | Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013) | 2012 | Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’ | FLAT RATE | 10,00 % | EUR | - 5 560,80 | 0,00 | - 5 560,80 |
| | Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013) | 2013 | Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’ | FLAT RATE | 10,00 % | EUR | - 6 579,04 | 0,00 | - 6 579,04 |
| | Rural Development EAFRD Investment - public beneficiaries | 2014 | Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’ | FLAT RATE | 10,00 % | EUR | - 4 875,00 | - 2 437,50 | - 2 437,50 |
| | Rural Development EAFRD Measures with flat-rate support | 2015 | Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’ | FLAT RATE | 10,00 % | EUR | - 28 776,35 | - 28 776,35 | 0,00 |
| | Rural Development EAFRD investment - public beneficiaries | 2015 | Deficiencies in the execution of the key control ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 3 506,13 | - 3 506,13 | 0,00 |
| | Rural Development EAFRD Investment - public beneficiaries | 2014 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 73 581,42 | 0,00 | - 73 581,42 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 162 273,81 | - 161 526,67 | - 747,14 |
| | Rural Development EAFRD investment - public beneficiaries | 2015 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 797 732,62 | - 797 732,62 | 0,00 |
| | Rural Development EAFRD Measures with flat-rate support | 2015 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 265 184,89 | - 265 184,89 | 0,00 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 147 822,70 | - 86 087,35 | - 61 735,35 |
| | Rural Development EAFRD investment - public beneficiaries | 2016 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 560 112,80 | - 363 185,54 | - 196 927,26 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 110 309,10 | - 71 526,07 | - 38 783,03 |
| | Rural Development EAFRD investment - private beneficiaries | 2017 | deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’ | FLAT RATE | 5,00 % | EUR | - 35 929,52 | - 24 437,81 | - 11 491,71 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | OTSC not performed before the final payment - Follow up of RD3/2014/012/FR | FLAT RATE | 2,00 % | EUR | - 7 141,25 | 0,00 | - 7 141,25 |
| | Rural Development EAFRD Measures with flat-rate support | 2017 | OTSC not performed before the final payment - Follow up of RD3/2014/012/FR | FLAT RATE | 2,00 % | EUR | - 86 868,35 | 0,00 | - 86 868,35 |
| | Rural Development EAFRD Measures with flat-rate support | 2018 | OTSC not performed before the final payment - Follow up of RD3/2014/012/FR | FLAT RATE | 2,00 % | EUR | - 329,60 | 0,00 | - 329,60 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Reasonableness of the costs not assessed with the required quality | FLAT RATE | 2,66 % | EUR | - 458 109,26 | - 457 977,66 | - 131,60 |
| | Rural Development EAFRD investment - private beneficiaries | 2017 | Reasonableness of the costs not assessed with the required quality | FLAT RATE | 2,66 % | EUR | - 253 541,50 | 0,00 | - 253 541,50 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Reasonableness of the costs not assessed with the required quality | FLAT RATE | 4,14 % | EUR | - 913 484,71 | - 820 627,41 | - 92 857,30 |
| | Rural Development EAFRD investment - private beneficiaries | 2017 | Reasonableness of the costs not assessed with the required quality | FLAT RATE | 4,14 % | EUR | - 129 621,33 | - 64 754,26 | - 64 867,07 |
| | | | | | Total FR: | EUR | -4 051 340,18 | -3 147 760,26 | - 903 579,92 |
| GB | Rural Development EAFRD measures subject to IACS | 2018 | Checks of the active farmer status - impact on RD 2017 | FLAT RATE | 2,00 % | EUR | - 1 313,52 | 0,00 | - 1 313,52 |
| | Rural Development EAFRD measures subject to IACS | 2017 | Weakness in the definition of Active Farmer- connected companies (Natural constraints) | ONE OFF | | EUR | - 81 774,79 | 0,00 | - 81 774,79 |
| | | | | | Total GB: | EUR | - 83 088,31 | 0,00 | - 83 088,31 |
| HU | Rural Development EAFRD measures subject to IACS | 2017 | No application of reductions related with late submission of payment claims (M14 of RDP 2014-2020) - FY2017 | FLAT RATE | 5,00 % | EUR | -1 080 678,64 | 0,00 | -1 080 678,64 |
| | Rural Development EAFRD measures subject to IACS | 2016 | No verification of all animals during the on-the-spot-checks (Measure 215 of RDP 2007-2013); No application of reductions related with late submission of payment claims (Measure 215 of RDP 2007-2013; M14 of RDP 2014-2020) - FY2016 | FLAT RATE | 5,00 % | EUR | -1 011 685,76 | 0,00 | -1 011 685,76 |
| | Rural Development EAFRD Axis 2 (2007-2013, area related measures) | 2014 | Sanction system in the last year of RD programme – Warning letter (Measure 214 of RDP 2007-2013) - CY 2013 | FLAT RATE | 10,00 % | EUR | - 20 339,71 | 0,00 | - 20 339,71 |
| | | | | | Total HU: | EUR | -2 112 704,11 | 0,00 | -2 112 704,11 |
| IE | Rural Development EAFRD measures subject to IACS | 2016 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | - 483 545,11 | 0,00 | - 483 545,11 |
| | Rural Development EAFRD measures subject to IACS | 2017 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | - 466 516,59 | 0,00 | - 466 516,59 |
| | Rural Development EAFRD measures subject to IACS | 2018 | Weaknesses LPIS | ESTIMATED BY AMOUNT | | EUR | - 284 061,57 | 0,00 | - 284 061,57 |
| | | | | | Total IE: | EUR | -1 234 123,27 | 0,00 | -1 234 123,27 |
| IT | Cross-compliance | 2016 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 7 296,99 | - 66,24 | - 7 230,75 |
| | Cross-compliance | 2017 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 2 923,66 | 0,00 | - 2 923,66 |
| | Cross-compliance | 2018 | Deficient I&R checks under SMR 7 - CY 2015 | FLAT RATE | 2,00 % | EUR | - 99,12 | 0,00 | - 99,12 |
| | Cross-compliance | 2017 | Deficient I&R checks under SMR 7 - CY 2016 | FLAT RATE | 2,00 % | EUR | - 27 283,36 | 0,00 | - 27 283,36 |
| | Cross-compliance | 2018 | Deficient I&R checks under SMR 7 - CY 2016 | FLAT RATE | 2,00 % | EUR | - 2 117,20 | 0,00 | - 2 117,20 |
| | Certification | 2017 | Errors in the EAFRD | ONE OFF | | EUR | - 29 136,27 | - 319,58 | - 28 816,69 |
| | Certification | 2017 | Known error (EAFRD) | ONE OFF | | EUR | - 121 884,94 | 0,00 | - 121 884,94 |
| | Rural Development EAFRD Investment - public beneficiaries | 2014 | Public Procurement Procedures not properly checked (artificial splitting) | ONE OFF | | EUR | - 431 400,00 | 0,00 | - 431 400,00 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | Public Procurement Procedures not properly checked (artificial splitting) | ONE OFF | | EUR | - 330 045,02 | 0,00 | - 330 045,02 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Public Procurement Procedures not properly checked (artificial splitting) | ONE OFF | | EUR | - 15 123,95 | 0,00 | - 15 123,95 |
| | Rural Development EAFRD Investment - public beneficiaries | 2014 | Public Procurement Procedures not properly checked (Awarding decision not properly justified) | ONE OFF | | EUR | - 44 449,58 | 0,00 | - 44 449,58 |
| | Rural Development EAFRD investment - public beneficiaries | 2015 | Public Procurement Procedures not properly checked (Awarding decision not properly justified) | ONE OFF | | EUR | - 28 584,53 | 0,00 | - 28 584,53 |
| | Rural Development EAFRD investment - public beneficiaries | 2016 | Public Procurement Procedures not properly checked (Awarding decision not properly justified) | ONE OFF | | EUR | - 7 895,28 | 0,00 | - 7 895,28 |
| | | | | | Total IT: | EUR | -1 048 239,90 | - 385,82 | -1 047 854,08 |
| LT | Rural Development EAFRD investment - private beneficiaries | 2016 | M121 + M123- Scope of on-the-spot checks and checks on reasonableness of costs | FLAT RATE | 5,00 % | EUR | -1 109 209,77 | 0,00 | -1 109 209,77 |
| | Rural Development EAFRD Measures with flat-rate support | 2015 | M311 - Ineligible car costs (-5 % flat-rate correction from enquiry RD1/2014/834/LT) | ONE OFF | | EUR | - 25 892,39 | - 1 294,62 | - 24 597,77 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | M311 - Reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 7 070,44 | 0,00 | - 7 070,44 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | M312 - Scope of on-the-spot checks and checks on reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 297 843,38 | 0,00 | - 297 843,38 |
| | | | | | Total LT: | EUR | -1 440 015,98 | - 1 294,62 | -1 438 721,36 |
| LU | Rural Development EAFRD measures subject to IACS | 2016 | EAFRD M10 and M11: Insufficient quantity of on-the-spot checks | ONE OFF | | EUR | - 25 037,52 | 0,00 | - 25 037,52 |
| | Rural Development EAFRD measures subject to IACS | 2017 | EAFRD M10 and M11: Insufficient quantity of on-the-spot checks | ONE OFF | | EUR | - 4 245,01 | 0,00 | - 4 245,01 |
| | Rural Development EAFRD measures subject to IACS | 2016 | M10 and M11: Absence of on-the-spot checks | FLAT RATE | 5,00 % | EUR | - 27 749,53 | 0,00 | - 27 749,53 |
| | Rural Development EAFRD measures subject to IACS | 2017 | M10 and M11: Absence of on-the-spot checks | FLAT RATE | 5,00 % | EUR | - 55 330,54 | 0,00 | - 55 330,54 |
| | Rural Development EAFRD measures subject to IACS | 2018 | M10 and M11: Absence of on-the-spot checks | FLAT RATE | 5,00 % | EUR | - 61 198,87 | 0,00 | - 61 198,87 |
| | Rural Development EAFRD measures subject to IACS | 2016 | M11: payments executed before the completion of the administrative checks | ONE OFF | | EUR | - 962,05 | 0,00 | - 962,05 |
| | Rural Development EAFRD measures subject to IACS | 2017 | M11: payments executed before the completion of the administrative checks | ONE OFF | | EUR | - 263,51 | 0,00 | - 263,51 |
| | Rural Development EAFRD investment - public beneficiaries | 2016 | M20: weak checks on the eligibility of the costs | ONE OFF | | EUR | - 24 360,56 | 0,00 | - 24 360,56 |
| | Rural Development EAFRD investment - public beneficiaries | 2017 | M20: weak checks on the eligibility of the costs | ONE OFF | | EUR | - 38 435,81 | 0,00 | - 38 435,81 |
| | Rural Development EAFRD Measures with flat-rate support | 2017 | M6.1: weak checks on the eligibility of the project (Business Plans) | ONE OFF | | EUR | - 47 340,00 | 0,00 | - 47 340,00 |
| | Rural Development EAFRD Measures with flat-rate support | 2018 | M6.1: weak checks on the eligibility of the project (Business Plans) | ONE OFF | | EUR | - 11 835,00 | 0,00 | - 11 835,00 |
| | | | | | Total LU: | EUR | - 296 758,40 | 0,00 | - 296 758,40 |
| MT | Rural Development EAFRD investment - private beneficiaries | 2015 | Appropriate evaluation of the reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 639,69 | - 199,58 | - 440,11 |
| | Rural Development EAFRD Leader | 2015 | Appropriate evaluation of the reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 264,48 | - 82,52 | - 181,96 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Appropriate evaluation of the reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 30 407,39 | 0,00 | - 30 407,39 |
| | Rural Development EAFRD Leader | 2016 | Appropriate evaluation of the reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 253,80 | 0,00 | - 253,80 |
| | Rural Development EAFRD Measures with flat-rate support | 2016 | Appropriate evaluation of the reasonableness of costs | FLAT RATE | 5,00 % | EUR | - 4 212,63 | 0,00 | - 4 212,63 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | Performance of OTSC of sufficient quality | ONE OFF | | EUR | - 64 128,03 | - 1 000,40 | - 63 127,63 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Performance of OTSC of sufficient quality | ONE OFF | | EUR | - 41 890,44 | 0,00 | - 41 890,44 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 but not SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 144,27 | 0,00 | - 144,27 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 79,81 | 0,00 | - 79,81 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision | FLAT RATE | 2,00 % | EUR | - 88,00 | 0,00 | - 88,00 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 and SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 84,04 | 0,00 | - 84,04 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 75,05 | 0,00 | - 75,05 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 73,91 | 0,00 | - 73,91 |
| | Cross-compliance | 2016 | CY 2015 - Beneficiaries subject to the requirements of SMR 8 only - No evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 400,38 | 0,00 | - 400,38 |
| | Cross-compliance | 2017 | CY 2016 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR7 - Deficient on-the-spot checks of animal-related SMRs and/or no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 465,51 | 0,00 | - 465,51 |
| | Cross-compliance | 2018 | CY 2017 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures | FLAT RATE | 2,00 % | EUR | - 445,90 | 0,00 | - 445,90 |
| | | | | | Total MT: | EUR | - 143 653,33 | - 1 282,50 | - 142 370,83 |
| NL | Rural Development EAFRD Risk management | 2016 | Deficiency regarding active farmer status - impact on RD | ONE OFF | | EUR | - 19 981,45 | 0,00 | - 19 981,45 |
| | Rural Development EAFRD measures subject to IACS | 2018 | LPIS and other weaknesses | ONE OFF | | EUR | - 29 502,31 | 0,00 | - 29 502,31 |
| | Rural Development EAFRD measures subject to IACS | 2017 | Weaknesses in the LPIS (EAFRD) | ONE OFF | | EUR | - 805 547,41 | 0,00 | - 805 547,41 |
| | | | | | Total NL: | EUR | - 855 031,17 | 0,00 | - 855 031,17 |
| PT | Rural Development EAFRD forestry measures | 2016 | Double-financing between M8 (first afforestation) and EFA greening - FY 2016. | ONE OFF | | EUR | - 45 335,01 | - 166,16 | - 45 168,85 |
| | Rural Development EAFRD forestry measures | 2017 | Double-financing between M8 (first afforestation) and EFA greening - FY 2017. | ONE OFF | | EUR | - 62 829,11 | 0,00 | - 62 829,11 |
| | Rural Development EAFRD forestry measures | 2018 | Double-financing between M8 (first afforestation) and EFA greening - FY 2018 + FY 2019 | ONE OFF | | EUR | - 64 068,90 | 0,00 | - 64 068,90 |
| | Rural Development EAFRD forestry measures | 2019 | Double-financing between M8 (first afforestation) and EFA greening - FY 2018 + FY 2019 | ONE OFF | | EUR | - 2 485,97 | 0,00 | - 2 485,97 |
| | | | | | Total PT: | EUR | - 174 718,99 | - 166,16 | - 174 552,83 |
| RO | Certification | 2017 | Individual errors in EAFRD. | ONE OFF | | EUR | - 54 870,22 | 0,00 | - 54 870,22 |
| | | | | | Total RO: | EUR | - 54 870,22 | 0,00 | - 54 870,22 |
| SE | Rural Development EAFRD investment - private beneficiaries | 2015 | 1 KC - Selection and appraisal of projects applications | FLAT RATE | 5,00 % | EUR | - 45 164,84 | - 45 164,84 | 0,00 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | 1 KC - Selection and appraisal of projects applications | FLAT RATE | 5,00 % | EUR | - 3 966,68 | 0,00 | - 3 966,68 |
| | Rural Development EAFRD investment - private beneficiaries | 2017 | KC Appropriate checks to ensure that investment/project/application fulfil all eligibility criteria as laid down in the EU legislation and the eligibility criteria as laid down in the RDP of the Member State or region (M04.4) | ONE OFF | | EUR | - 15 197,09 | 0,00 | - 15 197,09 |
| | Rural Development EAFRD investment - private beneficiaries | 2018 | KC Appropriate checks to ensure that investment/project/application fulfil all eligibility criteria as laid down in the EU legislation and the eligibility criteria as laid down in the RDP of the Member State or region (M04.4) | ONE OFF | | EUR | - 21 238,15 | 0,00 | - 21 238,15 |
| | Rural Development EAFRD investment - private beneficiaries | 2015 | Selection and appraisal of projects/applications (M121) | FLAT RATE | 5,00 % | EUR | - 9 197,44 | - 9 197,44 | 0,00 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Selection and appraisal of projects/applications (M121) | FLAT RATE | 5,00 % | EUR | - 300,26 | - 300,26 | 0,00 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Transitional expenditure (M121) | FLAT RATE | 5,00 % | EUR | - 185,67 | 0,00 | - 185,67 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | Transitional expenditure (M216) | FLAT RATE | 5,00 % | EUR | - 949,82 | 0,00 | - 949,82 |
| | Rural Development EAFRD investment - private beneficiaries | 2016 | weakness in reasonableness of costs to be covered by public procurement procedures (M216) | FLAT RATE | 5,00 % | EUR | - 3 685,07 | 0,00 | - 3 685,07 |
| | Rural Development EAFRD measures subject to IACS | 2017 | Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016 | ESTIMATED BY PERCENTAGE | 0,58 % | EUR | - 1 824,63 | 0,00 | - 17 824,63 |
| | | | | | Total SE: | EUR | - 117 709,65 | - 54 662,54 | - 63 047,11 |
| SK | Rural Development EAFRD forestry measures | 2016 | M8.3 and M8.4: deficiency in key control 'Selection and appraisal of projects' - CY2015 and 2016 - FY2016 and 2017 | FLAT RATE | 5,00 % | EUR | - 214 806,09 | - 168 268,94 | - 46 537,15 |
| | Rural Development EAFRD forestry measures | 2017 | M8.3 and M8.4: deficiency in key control 'Selection and appraisal of projects' - CY2015 and 2016 - FY2016 and 2017 | FLAT RATE | 5,00 % | EUR | -1 326 332,65 | 0,00 | -1 326 332,65 |
| | | | | | Total SK: | EUR | -1 541 138,74 | - 168 268,94 | -1 372 869,80 |

Member State

Measure

FY

Reason

Type

Correction %

Currency

Amount

Deductions

Financial Impact

BE

Clearance of Accounts - Financial Clearance

2017

Substantial error on sampling (Annex 15 of CB report)

ONE OFF

EUR

- 3 869,02

0,00

- 3 869,02

Clearance of Accounts - Financial Clearance

2017

Substantial error on sampling (annex 14 of CB report)

ONE OFF

EUR

- 205,57

0,00

- 205,57

Total BE:

EUR

- 4 074,59

0,00

- 4 074,59

BG

Cross-compliance

2016

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

- 223 326,63

- 8 009,67

- 215 316,96

Cross-compliance

2017

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

- 834,40

0,00

- 834,40

Cross-compliance

2018

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2015

FLAT RATE

5,00 %

EUR

- 293,61

0,00

- 293,61

Cross-compliance

2017

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 184 118,40

- 688,70

- 183 429,70

Cross-compliance

2018

Deficient on-the-spot checks of animal-related SMRs - Deficient reporting - CY 2016

FLAT RATE

5,00 %

EUR

- 8 204,10

0,00

- 8 204,10

Total BG:

EUR

- 416 777,14

- 8 698,37

- 408 078,77

CZ

Rural Development EAFRD measures subject to IACS

2016

M10: double financing

ONE OFF

EUR

- 7 674,67

0,00

- 7 674,67

Rural Development EAFRD measures subject to IACS

2017

M10: double financing

ONE OFF

EUR

- 7 484,02

0,00

- 7 484,02

Rural Development EAFRD measures subject to IACS

2017

M14: advance notification of on-the-spot checks - FY2017

FLAT RATE

5,00 %

EUR

- 14 191,54

0,00

- 14 191,54

Rural Development EAFRD measures subject to IACS

2018

M14: advance notification of on-the-spot checks - FY2018 and FY2019

FLAT RATE

5,00 %

EUR

- 15 511,62

0,00

- 15 511,62

Rural Development EAFRD measures subject to IACS

2019

M14: advance notification of on-the-spot checks - FY2018 and FY2019

FLAT RATE

5,00 %

EUR

- 5 405,86

0,00

- 5 405,86

Total CZ:

EUR

- 50 267,71

0,00

- 50 267,71

DE

Certification

2017

Differences in debts' reconciliation EAFRD

ONE OFF

EUR

- 9 497,41

0,00

- 9 497,41

Rural Development EAFRD forestry measures

2016

Double-financing between M8 (first afforestation) and EFA greening - FY 2016.

ONE OFF

EUR

- 10 543,25

0,00

- 10 543,25

Rural Development EAFRD forestry measures

2017

Double-financing between M8 (first afforestation) and EFA greening - FY 2017.

ONE OFF

EUR

- 8 997,06

0,00

- 8 997,06

Rural Development EAFRD forestry measures

2018

Double-financing between M8 (first afforestation) and EFA greening - FY 2018.

ONE OFF

EUR

- 8 919,87

0,00

- 8 919,87

Clearance of Accounts - Financial Clearance

2017

Financial errors found in substantive testing on EAFRD (annexes 11, 7a, 7b) of CB report

ONE OFF

EUR

- 35 267,33

0,00

- 35 267,33

Certification

2017

Individual errors in EAFRD

ONE OFF

EUR

- 7 618,01

0,00

- 7 618,01

Total DE:

EUR

- 80 842,93

0,00

- 80 842,93

ES

Rural Development EAFRD investment - private beneficiaries

2018

M121: 5 % flat rate correction (transitional expenditure on M04 in FY2018)

FLAT RATE

5,00 %

EUR

- 2 447,56

0,00

- 2 447,56

Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013)

2013

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2013)

FLAT RATE

5,00 %

EUR

- 24 078,53

0,00

- 24 078,53

Rural Development EAFRD Investment - private beneficiaries

2014

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2014)

FLAT RATE

5,00 %

EUR

- 29 716,69

0,00

- 29 716,69

Rural Development EAFRD investment - private beneficiaries

2016

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FY: 2016)

FLAT RATE

5,00 %

EUR

- 576 669,13

0,00

- 576 669,13

Rural Development EAFRD Measures with flat-rate support

2016

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction. FYs 2016, 2017 [transitional expenditure on M06]

FLAT RATE

5,00 %

EUR

- 23 343,35

0,00

- 23 343,35

Rural Development EAFRD Measures with flat-rate support

2017

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction. FYs 2016, 2017 [transitional expenditure on M06]

FLAT RATE

5,00 %

EUR

- 3 889,09

0,00

- 3 889,09

Rural Development EAFRD investment - private beneficiaries

2015

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1]

FLAT RATE

5,00 %

EUR

- 35 782,98

0,00

- 35 782,98

Rural Development EAFRD investment - private beneficiaries

2016

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1]

FLAT RATE

5,00 %

EUR

- 58 528,57

0,00

- 58 528,57

Rural Development EAFRD investment - private beneficiaries

2017

M121: Weakness in KC (Verification of eligibility - 5 %) and lack of Ancillary Control (Audit trail - 2 %) => 5 % flat rate correction (FYs: 2015-2016-2017, incl. transitional expenditure on M04) [for FY 2016 and 2017: overlap with exp. on M4.1]

FLAT RATE

5,00 %

EUR

- 50 965,72

0,00

- 50 965,72

Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013)

2013

M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FY: 2013)

FLAT RATE

2,00 %

EUR

- 24 354,54

0,00

- 24 354,54

Rural Development EAFRD Investment - private beneficiaries

2014

M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FY: 2014)

FLAT RATE

2,00 %

EUR

- 6 109,94

0,00

- 6 109,94

Rural Development EAFRD investment - private beneficiaries

2015

M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FYs: 2015-2016-2017)

FLAT RATE

2,00 %

EUR

- 267 943,18

0,00

- 267 943,18

Rural Development EAFRD investment - private beneficiaries

2016

M123: Lack of Ancillary Control (Audit trail) => 2 % flat rate correction (FYs: 2015-2016-2017)

FLAT RATE

2,00 %

EUR

- 315 906,15

0,00

- 315 906,15

Total ES:

EUR

-1 419 735,43

0,00

-1 419 735,43

FR

Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013)

2012

Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’

FLAT RATE

10,00 %

EUR

- 5 560,80

0,00

- 5 560,80

Rural Development EAFRD Axis 1+3 - Investment orientated measures (2007-2013)

2013

Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’

FLAT RATE

10,00 %

EUR

- 6 579,04

0,00

- 6 579,04

Rural Development EAFRD Investment - public beneficiaries

2014

Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’

FLAT RATE

10,00 %

EUR

- 4 875,00

- 2 437,50

- 2 437,50

Rural Development EAFRD Measures with flat-rate support

2015

Absence of the key control ‘In-situ visits carried out for all investment operations to verify the realisation of the investment’

FLAT RATE

10,00 %

EUR

- 28 776,35

- 28 776,35

0,00

Rural Development EAFRD investment - public beneficiaries

2015

Deficiencies in the execution of the key control ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 3 506,13

- 3 506,13

0,00

Rural Development EAFRD Investment - public beneficiaries

2014

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 73 581,42

0,00

- 73 581,42

Rural Development EAFRD investment - private beneficiaries

2015

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 162 273,81

- 161 526,67

- 747,14

Rural Development EAFRD investment - public beneficiaries

2015

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 797 732,62

- 797 732,62

0,00

Rural Development EAFRD Measures with flat-rate support

2015

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 265 184,89

- 265 184,89

0,00

Rural Development EAFRD investment - private beneficiaries

2016

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 147 822,70

- 86 087,35

- 61 735,35

Rural Development EAFRD investment - public beneficiaries

2016

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 560 112,80

- 363 185,54

- 196 927,26

Rural Development EAFRD Measures with flat-rate support

2016

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 110 309,10

- 71 526,07

- 38 783,03

Rural Development EAFRD investment - private beneficiaries

2017

deficiency in the execution of the key controls ‘Verification that public procurement procedures are in compliance with national and Union regulations’ and ‘Appropriate evaluation of the reasonableness of costs’

FLAT RATE

5,00 %

EUR

- 35 929,52

- 24 437,81

- 11 491,71

Rural Development EAFRD Measures with flat-rate support

2016

OTSC not performed before the final payment - Follow up of RD3/2014/012/FR

FLAT RATE

2,00 %

EUR

- 7 141,25

0,00

- 7 141,25

Rural Development EAFRD Measures with flat-rate support

2017

OTSC not performed before the final payment - Follow up of RD3/2014/012/FR

FLAT RATE

2,00 %

EUR

- 86 868,35

0,00

- 86 868,35

Rural Development EAFRD Measures with flat-rate support

2018

OTSC not performed before the final payment - Follow up of RD3/2014/012/FR

FLAT RATE

2,00 %

EUR

- 329,60

0,00

- 329,60

Rural Development EAFRD investment - private beneficiaries

2016

Reasonableness of the costs not assessed with the required quality

FLAT RATE

2,66 %

EUR

- 458 109,26

- 457 977,66

- 131,60

Rural Development EAFRD investment - private beneficiaries

2017

Reasonableness of the costs not assessed with the required quality

FLAT RATE

2,66 %

EUR

- 253 541,50

0,00

- 253 541,50

Rural Development EAFRD investment - private beneficiaries

2016

Reasonableness of the costs not assessed with the required quality

FLAT RATE

4,14 %

EUR

- 913 484,71

- 820 627,41

- 92 857,30

Rural Development EAFRD investment - private beneficiaries

2017

Reasonableness of the costs not assessed with the required quality

FLAT RATE

4,14 %

EUR

- 129 621,33

- 64 754,26

- 64 867,07

Total FR:

EUR

-4 051 340,18

-3 147 760,26

- 903 579,92

GB

Rural Development EAFRD measures subject to IACS

2018

Checks of the active farmer status - impact on RD 2017

FLAT RATE

2,00 %

EUR

- 1 313,52

0,00

- 1 313,52

Rural Development EAFRD measures subject to IACS

2017

Weakness in the definition of Active Farmer- connected companies (Natural constraints)

ONE OFF

EUR

- 81 774,79

0,00

- 81 774,79

Total GB:

EUR

- 83 088,31

0,00

- 83 088,31

HU

Rural Development EAFRD measures subject to IACS

2017

No application of reductions related with late submission of payment claims (M14 of RDP 2014-2020) - FY2017

FLAT RATE

5,00 %

EUR

-1 080 678,64

0,00

-1 080 678,64

Rural Development EAFRD measures subject to IACS

2016

No verification of all animals during the on-the-spot-checks (Measure 215 of RDP 2007-2013); No application of reductions related with late submission of payment claims (Measure 215 of RDP 2007-2013; M14 of RDP 2014-2020) - FY2016

FLAT RATE

5,00 %

EUR

-1 011 685,76

0,00

-1 011 685,76

Rural Development EAFRD Axis 2 (2007-2013, area related measures)

2014

Sanction system in the last year of RD programme – Warning letter (Measure 214 of RDP 2007-2013) - CY 2013

FLAT RATE

10,00 %

EUR

- 20 339,71

0,00

- 20 339,71

Total HU:

EUR

-2 112 704,11

0,00

-2 112 704,11

IE

Rural Development EAFRD measures subject to IACS

2016

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

- 483 545,11

0,00

- 483 545,11

Rural Development EAFRD measures subject to IACS

2017

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

- 466 516,59

0,00

- 466 516,59

Rural Development EAFRD measures subject to IACS

2018

Weaknesses LPIS

ESTIMATED BY AMOUNT

EUR

- 284 061,57

0,00

- 284 061,57

Total IE:

EUR

-1 234 123,27

0,00

-1 234 123,27

IT

Cross-compliance

2016

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 7 296,99

- 66,24

- 7 230,75

Cross-compliance

2017

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 2 923,66

0,00

- 2 923,66

Cross-compliance

2018

Deficient I&R checks under SMR 7 - CY 2015

FLAT RATE

2,00 %

EUR

- 99,12

0,00

- 99,12

Cross-compliance

2017

Deficient I&R checks under SMR 7 - CY 2016

FLAT RATE

2,00 %

EUR

- 27 283,36

0,00

- 27 283,36

Cross-compliance

2018

Deficient I&R checks under SMR 7 - CY 2016

FLAT RATE

2,00 %

EUR

- 2 117,20

0,00

- 2 117,20

Certification

2017

Errors in the EAFRD

ONE OFF

EUR

- 29 136,27

- 319,58

- 28 816,69

Certification

2017

Known error (EAFRD)

ONE OFF

EUR

- 121 884,94

0,00

- 121 884,94

Rural Development EAFRD Investment - public beneficiaries

2014

Public Procurement Procedures not properly checked (artificial splitting)

ONE OFF

EUR

- 431 400,00

0,00

- 431 400,00

Rural Development EAFRD investment - private beneficiaries

2015

Public Procurement Procedures not properly checked (artificial splitting)

ONE OFF

EUR

- 330 045,02

0,00

- 330 045,02

Rural Development EAFRD investment - private beneficiaries

2016

Public Procurement Procedures not properly checked (artificial splitting)

ONE OFF

EUR

- 15 123,95

0,00

- 15 123,95

Rural Development EAFRD Investment - public beneficiaries

2014

Public Procurement Procedures not properly checked (Awarding decision not properly justified)

ONE OFF

EUR

- 44 449,58

0,00

- 44 449,58

Rural Development EAFRD investment - public beneficiaries

2015

Public Procurement Procedures not properly checked (Awarding decision not properly justified)

ONE OFF

EUR

- 28 584,53

0,00

- 28 584,53

Rural Development EAFRD investment - public beneficiaries

2016

Public Procurement Procedures not properly checked (Awarding decision not properly justified)

ONE OFF

EUR

- 7 895,28

0,00

- 7 895,28

Total IT:

EUR

-1 048 239,90

- 385,82

-1 047 854,08

LT

Rural Development EAFRD investment - private beneficiaries

2016

M121 + M123- Scope of on-the-spot checks and checks on reasonableness of costs

FLAT RATE

5,00 %

EUR

-1 109 209,77

0,00

-1 109 209,77

Rural Development EAFRD Measures with flat-rate support

2015

M311 - Ineligible car costs (-5 % flat-rate correction from enquiry RD1/2014/834/LT)

ONE OFF

EUR

- 25 892,39

- 1 294,62

- 24 597,77

Rural Development EAFRD Measures with flat-rate support

2016

M311 - Reasonableness of costs

FLAT RATE

5,00 %

EUR

- 7 070,44

0,00

- 7 070,44

Rural Development EAFRD Measures with flat-rate support

2016

M312 - Scope of on-the-spot checks and checks on reasonableness of costs

FLAT RATE

5,00 %

EUR

- 297 843,38

0,00

- 297 843,38

Total LT:

EUR

-1 440 015,98

- 1 294,62

-1 438 721,36

LU

Rural Development EAFRD measures subject to IACS

2016

EAFRD M10 and M11: Insufficient quantity of on-the-spot checks

ONE OFF

EUR

- 25 037,52

0,00

- 25 037,52

Rural Development EAFRD measures subject to IACS

2017

EAFRD M10 and M11: Insufficient quantity of on-the-spot checks

ONE OFF

EUR

- 4 245,01

0,00

- 4 245,01

Rural Development EAFRD measures subject to IACS

2016

M10 and M11: Absence of on-the-spot checks

FLAT RATE

5,00 %

EUR

- 27 749,53

0,00

- 27 749,53

Rural Development EAFRD measures subject to IACS

2017

M10 and M11: Absence of on-the-spot checks

FLAT RATE

5,00 %

EUR

- 55 330,54

0,00

- 55 330,54

Rural Development EAFRD measures subject to IACS

2018

M10 and M11: Absence of on-the-spot checks

FLAT RATE

5,00 %

EUR

- 61 198,87

0,00

- 61 198,87

Rural Development EAFRD measures subject to IACS

2016

M11: payments executed before the completion of the administrative checks

ONE OFF

EUR

- 962,05

0,00

- 962,05

Rural Development EAFRD measures subject to IACS

2017

M11: payments executed before the completion of the administrative checks

ONE OFF

EUR

- 263,51

0,00

- 263,51

Rural Development EAFRD investment - public beneficiaries

2016

M20: weak checks on the eligibility of the costs

ONE OFF

EUR

- 24 360,56

0,00

- 24 360,56

Rural Development EAFRD investment - public beneficiaries

2017

M20: weak checks on the eligibility of the costs

ONE OFF

EUR

- 38 435,81

0,00

- 38 435,81

Rural Development EAFRD Measures with flat-rate support

2017

M6.1: weak checks on the eligibility of the project (Business Plans)

ONE OFF

EUR

- 47 340,00

0,00

- 47 340,00

Rural Development EAFRD Measures with flat-rate support

2018

M6.1: weak checks on the eligibility of the project (Business Plans)

ONE OFF

EUR

- 11 835,00

0,00

- 11 835,00

Total LU:

EUR

- 296 758,40

0,00

- 296 758,40

MT

Rural Development EAFRD investment - private beneficiaries

2015

Appropriate evaluation of the reasonableness of costs

FLAT RATE

5,00 %

EUR

- 639,69

- 199,58

- 440,11

Rural Development EAFRD Leader

2015

Appropriate evaluation of the reasonableness of costs

FLAT RATE

5,00 %

EUR

- 264,48

- 82,52

- 181,96

Rural Development EAFRD investment - private beneficiaries

2016

Appropriate evaluation of the reasonableness of costs

FLAT RATE

5,00 %

EUR

- 30 407,39

0,00

- 30 407,39

Rural Development EAFRD Leader

2016

Appropriate evaluation of the reasonableness of costs

FLAT RATE

5,00 %

EUR

- 253,80

0,00

- 253,80

Rural Development EAFRD Measures with flat-rate support

2016

Appropriate evaluation of the reasonableness of costs

FLAT RATE

5,00 %

EUR

- 4 212,63

0,00

- 4 212,63

Rural Development EAFRD investment - private beneficiaries

2015

Performance of OTSC of sufficient quality

ONE OFF

EUR

- 64 128,03

- 1 000,40

- 63 127,63

Rural Development EAFRD investment - private beneficiaries

2016

Performance of OTSC of sufficient quality

ONE OFF

EUR

- 41 890,44

0,00

- 41 890,44

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 but not SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 144,27

0,00

- 144,27

Cross-compliance

2017

CY 2016 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 79,81

0,00

- 79,81

Cross-compliance

2018

CY 2017 - Beneficiaries subject to the requirements of SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision

FLAT RATE

2,00 %

EUR

- 88,00

0,00

- 88,00

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 7 and SMR 8 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 84,04

0,00

- 84,04

Cross-compliance

2017

CY 2016 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 75,05

0,00

- 75,05

Cross-compliance

2018

CY 2017 - Beneficiaries subject to combinations of SMRs - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 73,91

0,00

- 73,91

Cross-compliance

2016

CY 2015 - Beneficiaries subject to the requirements of SMR 8 only - No evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 400,38

0,00

- 400,38

Cross-compliance

2017

CY 2016 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR7 - Deficient on-the-spot checks of animal-related SMRs and/or no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 465,51

0,00

- 465,51

Cross-compliance

2018

CY 2017 - Beneficiaries subject to the requirements of SMR 6 and/or SMR 8 and not subject to SMR 7 - Deficient on-the-spot checks of animal-related SMRs and no evidence of adequate supervision procedures

FLAT RATE

2,00 %

EUR

- 445,90

0,00

- 445,90

Total MT:

EUR

- 143 653,33

- 1 282,50

- 142 370,83

NL

Rural Development EAFRD Risk management

2016

Deficiency regarding active farmer status - impact on RD

ONE OFF

EUR

- 19 981,45

0,00

- 19 981,45

Rural Development EAFRD measures subject to IACS

2018

LPIS and other weaknesses

ONE OFF

EUR

- 29 502,31

0,00

- 29 502,31

Rural Development EAFRD measures subject to IACS

2017

Weaknesses in the LPIS (EAFRD)

ONE OFF

EUR

- 805 547,41

0,00

- 805 547,41

Total NL:

EUR

- 855 031,17

0,00

- 855 031,17

PT

Rural Development EAFRD forestry measures

2016

Double-financing between M8 (first afforestation) and EFA greening - FY 2016.

ONE OFF

EUR

- 45 335,01

- 166,16

- 45 168,85

Rural Development EAFRD forestry measures

2017

Double-financing between M8 (first afforestation) and EFA greening - FY 2017.

ONE OFF

EUR

- 62 829,11

0,00

- 62 829,11

Rural Development EAFRD forestry measures

2018

Double-financing between M8 (first afforestation) and EFA greening - FY 2018 + FY 2019

ONE OFF

EUR

- 64 068,90

0,00

- 64 068,90

Rural Development EAFRD forestry measures

2019

Double-financing between M8 (first afforestation) and EFA greening - FY 2018 + FY 2019

ONE OFF

EUR

- 2 485,97

0,00

- 2 485,97

Total PT:

EUR

- 174 718,99

- 166,16

- 174 552,83

RO

Certification

2017

Individual errors in EAFRD.

ONE OFF

EUR

- 54 870,22

0,00

- 54 870,22

Total RO:

EUR

- 54 870,22

0,00

- 54 870,22

SE

Rural Development EAFRD investment - private beneficiaries

2015

1 KC - Selection and appraisal of projects applications

FLAT RATE

5,00 %

EUR

- 45 164,84

- 45 164,84

0,00

Rural Development EAFRD investment - private beneficiaries

2016

1 KC - Selection and appraisal of projects applications

FLAT RATE

5,00 %

EUR

- 3 966,68

0,00

- 3 966,68

Rural Development EAFRD investment - private beneficiaries

2017

KC Appropriate checks to ensure that investment/project/application fulfil all eligibility criteria as laid down in the EU legislation and the eligibility criteria as laid down in the RDP of the Member State or region (M04.4)

ONE OFF

EUR

- 15 197,09

0,00

- 15 197,09

Rural Development EAFRD investment - private beneficiaries

2018

KC Appropriate checks to ensure that investment/project/application fulfil all eligibility criteria as laid down in the EU legislation and the eligibility criteria as laid down in the RDP of the Member State or region (M04.4)

ONE OFF

EUR

- 21 238,15

0,00

- 21 238,15

Rural Development EAFRD investment - private beneficiaries

2015

Selection and appraisal of projects/applications (M121)

FLAT RATE

5,00 %

EUR

- 9 197,44

- 9 197,44

0,00

Rural Development EAFRD investment - private beneficiaries

2016

Selection and appraisal of projects/applications (M121)

FLAT RATE

5,00 %

EUR

- 300,26

- 300,26

0,00

Rural Development EAFRD investment - private beneficiaries

2016

Transitional expenditure (M121)

FLAT RATE

5,00 %

EUR

- 185,67

0,00

- 185,67

Rural Development EAFRD investment - private beneficiaries

2016

Transitional expenditure (M216)

FLAT RATE

5,00 %

EUR

- 949,82

0,00

- 949,82

Rural Development EAFRD investment - private beneficiaries

2016

weakness in reasonableness of costs to be covered by public procurement procedures (M216)

FLAT RATE

5,00 %

EUR

- 3 685,07

0,00

- 3 685,07

Rural Development EAFRD measures subject to IACS

2017

Weakness in the key control in respect of the administrative checks to establish access to the aid claimed regarding active farmer status CY2016

ESTIMATED BY PERCENTAGE

0,58 %

EUR

- 1 824,63

0,00

- 17 824,63

Total SE:

EUR

- 117 709,65

- 54 662,54

- 63 047,11

SK

Rural Development EAFRD forestry measures

2016

M8.3 and M8.4: deficiency in key control 'Selection and appraisal of projects' - CY2015 and 2016 - FY2016 and 2017

FLAT RATE

5,00 %

EUR

- 214 806,09

- 168 268,94

- 46 537,15

Rural Development EAFRD forestry measures

2017

M8.3 and M8.4: deficiency in key control 'Selection and appraisal of projects' - CY2015 and 2016 - FY2016 and 2017

FLAT RATE

5,00 %

EUR

-1 326 332,65

0,00

-1 326 332,65

Total SK:

EUR

-1 541 138,74

- 168 268,94

-1 372 869,80

| Currency | Amount | Deductions | Financial Impact |
| --- | --- | --- | --- |
| EUR | -15 125 090,05 | -3 382 519,21 | -11 742 570,84 |

Currency

Amount

Deductions

Financial Impact

EUR

-15 125 090,05

-3 382 519,21

-11 742 570,84

---

III Other acts

EUROPEAN ECONOMIC AREA

| 31.10.2019 | EN | Official Journal of the European Union | L 279/143 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/143

---

DECISION OF THE EEA JOINT COMMITTEE No 78/2019

of 29 March 2019

amending Annex IX (Financial services) to the EEA Agreement 2019/1836

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

| (1) | Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (1), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, is to be incorporated into the EEA Agreement. |
| --- | --- |

(1)

Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (1), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, is to be incorporated into the EEA Agreement.

| (2) | Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 amending Regulation (EU) No 600/2014 on markets in financial instruments, Regulation (EU) No 596/2014 on market abuse and Regulation (EU) No 909/2014 on improving securities settlement in the European Union and on central securities depositories (2) is to be incorporated into the EEA Agreement. |
| --- | --- |

(2)

Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 amending Regulation (EU) No 600/2014 on markets in financial instruments, Regulation (EU) No 596/2014 on market abuse and Regulation (EU) No 909/2014 on improving securities settlement in the European Union and on central securities depositories (2) is to be incorporated into the EEA Agreement.

| (3) | Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (3), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, is to be incorporated into the EEA Agreement. |
| --- | --- |

(3)

Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (3), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, is to be incorporated into the EEA Agreement.

| (4) | Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 amending Directive 2014/65/EU on markets in financial instruments (4) is to be incorporated into the EEA Agreement. |
| --- | --- |

(4)

Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 amending Directive 2014/65/EU on markets in financial instruments (4) is to be incorporated into the EEA Agreement.

| (5) | Directive 2014/65/EU repeals Directive 2004/39/EC of the European Parliament and of the Council (5), which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement. |
| --- | --- |

(5)

Directive 2014/65/EU repeals Directive 2004/39/EC of the European Parliament and of the Council (5), which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.

| (6) | Regulation (EU) No 600/2014 specifies cases in which the European Banking Authority (EBA) and European Securities and Markets Authority (ESMA) may temporarily prohibit or restrict certain financial activities, and lays down conditions thereto, in accordance with Article 9(5) of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6) and of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7), respectively. For the purposes of the EEA Agreement, these powers are to be exercised by the EFTA Surveillance Authority as regards the EFTA States, in accordance with points 31g and 31i of Annex IX to the EEA Agreement. To ensure integration of the expertise of EBA and ESMA in the process and consistency between the two pillars of the EEA, such decisions of the EFTA Surveillance Authority will be adopted on the basis of drafts prepared by EBA or ESMA, as the case may be. This will preserve key advantages of supervision by a single authority. |
| --- | --- |

(6)

Regulation (EU) No 600/2014 specifies cases in which the European Banking Authority (EBA) and European Securities and Markets Authority (ESMA) may temporarily prohibit or restrict certain financial activities, and lays down conditions thereto, in accordance with Article 9(5) of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6) and of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7), respectively. For the purposes of the EEA Agreement, these powers are to be exercised by the EFTA Surveillance Authority as regards the EFTA States, in accordance with points 31g and 31i of Annex IX to the EEA Agreement. To ensure integration of the expertise of EBA and ESMA in the process and consistency between the two pillars of the EEA, such decisions of the EFTA Surveillance Authority will be adopted on the basis of drafts prepared by EBA or ESMA, as the case may be. This will preserve key advantages of supervision by a single authority.

| (7) | The Contracting Parties share the understanding that this Decision implements the agreement that was reflected in the conclusions (8) of the EU and EEA EFTA Ministers of Finance and Economy of 14 October 2014 regarding the incorporation of the EU ESAs Regulations into the EEA Agreement. |
| --- | --- |

(7)

The Contracting Parties share the understanding that this Decision implements the agreement that was reflected in the conclusions (8) of the EU and EEA EFTA Ministers of Finance and Economy of 14 October 2014 regarding the incorporation of the EU ESAs Regulations into the EEA Agreement.

| (8) | Annex IX to the EEA Agreement should therefore be amended accordingly, |
| --- | --- |

(8)

Annex IX to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Annex IX to the EEA Agreement shall be amended as follows:

| 1. | The following is added in point 13b (Directive 2002/92/EC of the European Parliament and of the Council):

  ‘, as amended by:






  — | 32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116.’ |
| --- | --- | --- |

1.

The following is added in point 13b (Directive 2002/92/EC of the European Parliament and of the Council):

‘, as amended by:

—

32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116.’

| 2. | The text of point 31ba (Directive 2004/39/EC of the European Parliament and of the Council) is replaced by the following:

  ‘
  32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, as amended by:






  — | 32016 L 1034: Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 8). |
| --- | --- | --- |

2.

The text of point 31ba (Directive 2004/39/EC of the European Parliament and of the Council) is replaced by the following:

‘
  32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, as amended by:

—

32016 L 1034: Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 8).

The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptations:

| (a) | Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Directive, the EFTA States and their competent authorities, respectively. |
| --- | --- |

(a)

Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Directive, the EFTA States and their competent authorities, respectively.

| (b) | References to members of the ESCB shall be understood to include, in addition to their meaning in the Directive, the national central banks of the EFTA States. |
| --- | --- |

(b)

References to members of the ESCB shall be understood to include, in addition to their meaning in the Directive, the national central banks of the EFTA States.

| (c) | References to other acts in the Directive shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- |

(c)

References to other acts in the Directive shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (d) | In Article 3(2), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019” and the words “3 July 2019” shall read “five years thereafter”. |
| --- | --- |

(d)

In Article 3(2), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019” and the words “3 July 2019” shall read “five years thereafter”.

| (e) | In Article 16(11), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”. |
| --- | --- |

(e)

In Article 16(11), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”.

| (f) | In Article 41(2), the word “Union” shall be replaced by the word “EEA”. |
| --- | --- |

(f)

In Article 41(2), the word “Union” shall be replaced by the word “EEA”.

| (g) | In Article 57:






  (i) | in the second subparagraph of paragraph 5, the words “it shall take action” shall be replaced by the words “ESMA or, as the case may be, the EFTA Surveillance Authority shall take action”; |
| --- | --- | --- |

(g)

In Article 57:

(i)

in the second subparagraph of paragraph 5, the words “it shall take action” shall be replaced by the words “ESMA or, as the case may be, the EFTA Surveillance Authority shall take action”;

| (ii) | in paragraph 6, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(ii)

in paragraph 6, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (h) | In points (f) and (g) of Article 70(6), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”. |
| --- | --- |

(h)

In points (f) and (g) of Article 70(6), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”.

| (i) | In Article 79:






  (i) | in the second subparagraph of paragraph 1, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- | --- |

(i)

In Article 79:

(i)

in the second subparagraph of paragraph 1, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (ii) | in the fifth subparagraph of paragraph 1, the words “, the EFTA Surveillance Authority” shall be inserted after the words “the Commission, ESMA”. |
| --- | --- |

(ii)

in the fifth subparagraph of paragraph 1, the words “, the EFTA Surveillance Authority” shall be inserted after the words “the Commission, ESMA”.

| (j) | In Articles 81(5), 82(2) and 87(1), the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(j)

In Articles 81(5), 82(2) and 87(1), the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (k) | In Article 86, the words “ESMA, which” shall be replaced by the words “ESMA. ESMA or, as the case may be, the EFTA Surveillance Authority”. |
| --- | --- |

(k)

In Article 86, the words “ESMA, which” shall be replaced by the words “ESMA. ESMA or, as the case may be, the EFTA Surveillance Authority”.

| (l) | In Article 95(1), as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”.’ |
| --- | --- |

(l)

In Article 95(1), as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”.’

| 3. | The text of point 31baa (deleted) is replaced by the following:

  ‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, as amended by:






  — | 32016 R 1033: Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 1). |
| --- | --- | --- |

3.

The text of point 31baa (deleted) is replaced by the following:

‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, as amended by:

—

32016 R 1033: Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 1).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

| (a) | Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Regulation, the EFTA States and their competent authorities, respectively. |
| --- | --- |

(a)

Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Regulation, the EFTA States and their competent authorities, respectively.

| (b) | References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States. |
| --- | --- |

(b)

References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States.

| (c) | Unless otherwise provided for in this Agreement, the European Banking Authority (EBA) or the European Securities and Markets Authority (ESMA), as the case may be, and the EFTA Surveillance Authority shall cooperate, exchange information and consult each other for the purposes of the Regulation, in particular prior to taking any action. |
| --- | --- |

(c)

Unless otherwise provided for in this Agreement, the European Banking Authority (EBA) or the European Securities and Markets Authority (ESMA), as the case may be, and the EFTA Surveillance Authority shall cooperate, exchange information and consult each other for the purposes of the Regulation, in particular prior to taking any action.

| (d) | References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- |

(d)

References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (e) | References to the powers of ESMA under Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council in the Regulation shall be understood as referring, in the cases provided for in and in accordance with point 31i of this Annex, to the powers of the EFTA Surveillance Authority as regards the EFTA States. |
| --- | --- |

(e)

References to the powers of ESMA under Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council in the Regulation shall be understood as referring, in the cases provided for in and in accordance with point 31i of this Annex, to the powers of the EFTA Surveillance Authority as regards the EFTA States.

| (f) | In point (e) of Article 1(1):






  (i) | as regards the EFTA States, the words “competent authorities, ESMA and EBA” shall read “competent authorities and the EFTA Surveillance Authority”; |
| --- | --- | --- |

(f)

In point (e) of Article 1(1):

(i)

as regards the EFTA States, the words “competent authorities, ESMA and EBA” shall read “competent authorities and the EFTA Surveillance Authority”;

| (ii) | the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the words “powers of ESMA”. |
| --- | --- |

(ii)

the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the words “powers of ESMA”.

| (g) | In Article 4:






  (i) | in paragraph 4, the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”; |
| --- | --- | --- |

(g)

In Article 4:

(i)

in paragraph 4, the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”;

| (ii) | in paragraph 7, the words “or, as regards waivers granted by competent authorities of the EFTA States, before the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019” shall be inserted after the words “3 January 2018”. |
| --- | --- |

(ii)

in paragraph 7, the words “or, as regards waivers granted by competent authorities of the EFTA States, before the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019” shall be inserted after the words “3 January 2018”.

| (h) | In Articles 7(1), 9(2), 11(1) and 19(1), the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”. |
| --- | --- |

(h)

In Articles 7(1), 9(2), 11(1) and 19(1), the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”.

| (i) | In Article 36(5):






  (i) | in the first and second sentences, as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(i)

In Article 36(5):

(i)

in the first and second sentences, as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”;

| (ii) | the words “and shall include in the list all notifications received by the EFTA Surveillance Authority” shall be inserted after the words “ESMA shall publish a list of all notifications that it receives”. |
| --- | --- |

(ii)

the words “and shall include in the list all notifications received by the EFTA Surveillance Authority” shall be inserted after the words “ESMA shall publish a list of all notifications that it receives”.

| (j) | In Article 37(2):






  (i) | as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”; |
| --- | --- | --- |

(j)

In Article 37(2):

(i)

as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019”;

| (ii) | the words “Article 101 and 102 TFEU” shall be replaced by the words “Articles 53 and 54 of the EEA Agreement”. |
| --- | --- |

(ii)

the words “Article 101 and 102 TFEU” shall be replaced by the words “Articles 53 and 54 of the EEA Agreement”.

| (k) | In Article 40:






  (i) | as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “ESMA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(k)

In Article 40:

(i)

as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “ESMA” shall read “the EFTA Surveillance Authority”;

| (ii) | as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”; |
| --- | --- |

(ii)

as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”;

| (iii) | in paragraph 3, the words “after consulting the public bodies” shall be replaced by the words “after consultation by ESMA of the public bodies”; |
| --- | --- |

(iii)

in paragraph 3, the words “after consulting the public bodies” shall be replaced by the words “after consultation by ESMA of the public bodies”;

| (iv) | in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without ESMA issuing the opinion”; |
| --- | --- |

(iv)

in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without ESMA issuing the opinion”;

| (v) | in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”; |
| --- | --- |

(v)

in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”;

| (vi) | in paragraph 5, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA’s website” shall be inserted after the words “this Article”. |
| --- | --- |

(vi)

in paragraph 5, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA’s website” shall be inserted after the words “this Article”.

| (l) | In Article 41:






  (i) | as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “EBA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(l)

In Article 41:

(i)

as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “EBA” shall read “the EFTA Surveillance Authority”;

| (ii) | as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”; |
| --- | --- |

(ii)

as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”;

| (iii) | in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without EBA issuing the opinion”; |
| --- | --- |

(iii)

in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without EBA issuing the opinion”;

| (iv) | in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”; |
| --- | --- |

(iv)

in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”;

| (v) | in paragraph 5, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on EBA’s website” shall be inserted after the words “this Article”. |
| --- | --- |

(v)

in paragraph 5, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on EBA’s website” shall be inserted after the words “this Article”.

| (m) | In Article 45:






  (i) | in the paragraph 1, the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- | --- |

(m)

In Article 45:

(i)

in the paragraph 1, the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (ii) | in paragraphs 2, 4, 5, 8 and 9 and in the first subparagraph of paragraph 3, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- |

(ii)

in paragraphs 2, 4, 5, 8 and 9 and in the first subparagraph of paragraph 3, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (iii) | in the second and third subparagraphs of paragraph 3, the words “or, as the case may be, preparing drafts for the EFTA Surveillance Authority,” shall be inserted after the words “before taking any measure”; |
| --- | --- |

(iii)

in the second and third subparagraphs of paragraph 3, the words “or, as the case may be, preparing drafts for the EFTA Surveillance Authority,” shall be inserted after the words “before taking any measure”;

| (iv) | in paragraph 6, the words “any decision” shall read “each of its decisions”; |
| --- | --- |

(iv)

in paragraph 6, the words “any decision” shall read “each of its decisions”;

| (v) | in paragraph 6, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to impose or renew any measure referred to in paragraph 1(c). A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA’s website” shall be inserted after the words “paragraph 1(c)”; |
| --- | --- |

(v)

in paragraph 6, the words “. The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to impose or renew any measure referred to in paragraph 1(c). A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA’s website” shall be inserted after the words “paragraph 1(c)”;

| (vi) | in paragraph 7, the words “on the ESMA website or, as regards measures taken by the EFTA Surveillance Authority, when the notice is published on the website of the EFTA Surveillance Authority,” shall be inserted after the words “when the notice is published”.’ |
| --- | --- |

(vi)

in paragraph 7, the words “on the ESMA website or, as regards measures taken by the EFTA Surveillance Authority, when the notice is published on the website of the EFTA Surveillance Authority,” shall be inserted after the words “when the notice is published”.’

| 4. | The following indent is added in point 31bc (Regulation (EU) No 648/2012 of the European Parliament and of the Council):






  — | ‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54.’ |
| --- | --- | --- |

4.

The following indent is added in point 31bc (Regulation (EU) No 648/2012 of the European Parliament and of the Council):

—

‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54.’

Article 2

The texts of Regulations (EU) No 600/2014, as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, and (EU) 2016/1033 and Directives 2014/65/EU, as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, and (EU) 2016/1034 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on the day following the last notification under Article 103(1) of the EEA Agreement (9).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 29 March 2019.

For the EEA Joint Committee

The President

Claude MAERTEN

---

(1)  
  OJ L 173, 12.6.2014, p. 84.

1

(2)  
  OJ L 175, 30.6.2016, p. 1.

2

(3)  
  OJ L 173, 12.6.2014, p. 349.

3

(4)  
  OJ L 175, 30.6.2016, p. 8.

4

(5)  
  OJ L 145, 30.4.2004, p. 1.

5

(6)  
  OJ L 331, 15.12.2010, p. 12.

6

(7)  
  OJ L 331, 15.12.2010, p. 84.

7

(8)  Council Conclusions on the EU and EEA EFTA Ministers of Finance and Economy, 14178/1/14 REV 1.

8

(9)  Constitutional requirements indicated.

9

---

ANNEX

JOINT DECLARATION BY THE CONTRACTING PARTIES

to Decision of the EEA Joint Committee No 78/2019 of 29 March 2019 incorporating Directive 2014/65/EU into the EEA Agreement

The Contracting Parties share the understanding that the incorporation into the EEA Agreement of Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU is without prejudice to national rules of general application concerning the screening for security or public order of foreign direct investment.

---

| 31.10.2019 | EN | Official Journal of the European Union | L 279/149 |
| --- | --- | --- | --- |

31.10.2019

EN

Official Journal of the European Union

L 279/149

---

DECISION OF THE EEA JOINT COMMITTEE NO 85/2019

of 29 March 2019

amending Annex IX (Financial services) to the EEA Agreement 2019/1837

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2016/2020 of 26 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on criteria for determining whether derivatives subject to the clearing obligation should be subject to the trading obligation (1) is to be incorporated into the EEA Agreement. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) 2016/2020 of 26 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on criteria for determining whether derivatives subject to the clearing obligation should be subject to the trading obligation (1) is to be incorporated into the EEA Agreement.

| (2) | Commission Delegated Regulation (EU) 2016/2021 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on access in respect of benchmarks (2) is to be incorporated into the EEA Agreement. |
| --- | --- |

(2)

Commission Delegated Regulation (EU) 2016/2021 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on access in respect of benchmarks (2) is to be incorporated into the EEA Agreement.

| (3) | Commission Delegated Regulation (EU) 2016/2022 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards concerning the information for registration of third-country firms and the format of information to be provided to the clients (3) is to be incorporated into the EEA Agreement. |
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(3)

Commission Delegated Regulation (EU) 2016/2022 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards concerning the information for registration of third-country firms and the format of information to be provided to the clients (3) is to be incorporated into the EEA Agreement.

| (4) | Commission Delegated Regulation (EU) 2017/565 of 25 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive (4) is to be incorporated into the EEA Agreement. |
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(4)

Commission Delegated Regulation (EU) 2017/565 of 25 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive (4) is to be incorporated into the EEA Agreement.

| (5) | Commission Delegated Regulation (EU) 2017/566 of 18 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the ratio of unexecuted orders to transactions in order to prevent disorderly trading conditions (5) is to be incorporated into the EEA Agreement. |
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(5)

Commission Delegated Regulation (EU) 2017/566 of 18 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the ratio of unexecuted orders to transactions in order to prevent disorderly trading conditions (5) is to be incorporated into the EEA Agreement.

| (6) | Commission Delegated Regulation (EU) 2017/567 of 18 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to definitions, transparency, portfolio compression and supervisory measures on product intervention and positions (6) is to be incorporated into the EEA Agreement. |
| --- | --- |

(6)

Commission Delegated Regulation (EU) 2017/567 of 18 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to definitions, transparency, portfolio compression and supervisory measures on product intervention and positions (6) is to be incorporated into the EEA Agreement.

| (7) | Commission Delegated Regulation (EU) 2017/568 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the admission of financial instruments to trading on regulated markets (7) is to be incorporated into the EEA Agreement. |
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(7)

Commission Delegated Regulation (EU) 2017/568 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the admission of financial instruments to trading on regulated markets (7) is to be incorporated into the EEA Agreement.

| (8) | Commission Delegated Regulation (EU) 2017/569 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the suspension and removal of financial instruments from trading (8) is to be incorporated into the EEA Agreement. |
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(8)

Commission Delegated Regulation (EU) 2017/569 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the suspension and removal of financial instruments from trading (8) is to be incorporated into the EEA Agreement.

| (9) | Commission Delegated Regulation (EU) 2017/570 of 26 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the determination of a material market in terms of liquidity in relation to notifications of a temporary halt in trading (9) is to be incorporated into the EEA Agreement. |
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(9)

Commission Delegated Regulation (EU) 2017/570 of 26 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the determination of a material market in terms of liquidity in relation to notifications of a temporary halt in trading (9) is to be incorporated into the EEA Agreement.

| (10) | Commission Delegated Regulation (EU) 2017/571 of 2 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (10) is to be incorporated into the EEA Agreement. |
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(10)

Commission Delegated Regulation (EU) 2017/571 of 2 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (10) is to be incorporated into the EEA Agreement.

| (11) | Commission Delegated Regulation (EU) 2017/572 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on the specification of the offering of pre-and post-trade data and the level of disaggregation of data (11) is to be incorporated into the EEA Agreement. |
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(11)

Commission Delegated Regulation (EU) 2017/572 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on the specification of the offering of pre-and post-trade data and the level of disaggregation of data (11) is to be incorporated into the EEA Agreement.

| (12) | Commission Delegated Regulation (EU) 2017/573 of 6 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on requirements to ensure fair and non-discriminatory co-location services and fee structures (12) is to be incorporated into the EEA Agreement. |
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(12)

Commission Delegated Regulation (EU) 2017/573 of 6 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on requirements to ensure fair and non-discriminatory co-location services and fee structures (12) is to be incorporated into the EEA Agreement.

| (13) | Commission Delegated Regulation (EU) 2017/574 of 7 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the level of accuracy of business clocks (13) is to be incorporated into the EEA Agreement. |
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(13)

Commission Delegated Regulation (EU) 2017/574 of 7 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the level of accuracy of business clocks (13) is to be incorporated into the EEA Agreement.

| (14) | Commission Delegated Regulation (EU) 2017/575 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards concerning the data to be published by execution venues on the quality of execution of transactions (14) is to be incorporated into the EEA Agreement. |
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(14)

Commission Delegated Regulation (EU) 2017/575 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards concerning the data to be published by execution venues on the quality of execution of transactions (14) is to be incorporated into the EEA Agreement.

| (15) | Commission Delegated Regulation (EU) 2017/576 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the annual publication by investment firms of information on the identity of execution venues and on the quality of execution (15) is to be incorporated into the EEA Agreement. |
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(15)

Commission Delegated Regulation (EU) 2017/576 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the annual publication by investment firms of information on the identity of execution venues and on the quality of execution (15) is to be incorporated into the EEA Agreement.

| (16) | Commission Delegated Regulation (EU) 2017/577 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the volume cap mechanism and the provision of information for the purposes of transparency and other calculations (16) is to be incorporated into the EEA Agreement. |
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(16)

Commission Delegated Regulation (EU) 2017/577 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the volume cap mechanism and the provision of information for the purposes of transparency and other calculations (16) is to be incorporated into the EEA Agreement.

| (17) | Commission Delegated Regulation (EU) 2017/578 of 13 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying the requirements on market making agreements and schemes (17) is to be incorporated into the EEA Agreement. |
| --- | --- |

(17)

Commission Delegated Regulation (EU) 2017/578 of 13 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying the requirements on market making agreements and schemes (17) is to be incorporated into the EEA Agreement.

| (18) | Commission Delegated Regulation (EU) 2017/579 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the direct, substantial and foreseeable effect of derivative contracts within the Union and the prevention of the evasion of rules and obligations (18) is to be incorporated into the EEA Agreement. |
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(18)

Commission Delegated Regulation (EU) 2017/579 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the direct, substantial and foreseeable effect of derivative contracts within the Union and the prevention of the evasion of rules and obligations (18) is to be incorporated into the EEA Agreement.

| (19) | Commission Delegated Regulation (EU) 2017/580 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the maintenance of relevant data relating to orders in financial instruments (19) is to be incorporated into the EEA Agreement. |
| --- | --- |

(19)

Commission Delegated Regulation (EU) 2017/580 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the maintenance of relevant data relating to orders in financial instruments (19) is to be incorporated into the EEA Agreement.

| (20) | Commission Delegated Regulation (EU) 2017/581 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on clearing access in respect of trading venues and central counterparties (20) is to be incorporated into the EEA Agreement. |
| --- | --- |

(20)

Commission Delegated Regulation (EU) 2017/581 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on clearing access in respect of trading venues and central counterparties (20) is to be incorporated into the EEA Agreement.

| (21) | Commission Delegated Regulation (EU) 2017/582 of 29 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards specifying the obligation to clear derivatives traded on regulated markets and timing of acceptance for clearing (21) is to be incorporated into the EEA Agreement. |
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(21)

Commission Delegated Regulation (EU) 2017/582 of 29 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards specifying the obligation to clear derivatives traded on regulated markets and timing of acceptance for clearing (21) is to be incorporated into the EEA Agreement.

| (22) | Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives (22) is to be incorporated into the EEA Agreement. |
| --- | --- |

(22)

Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives (22) is to be incorporated into the EEA Agreement.

| (23) | Commission Delegated Regulation (EU) 2017/584 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying organisational requirements of trading venues (23) is to be incorporated into the EEA Agreement. |
| --- | --- |

(23)

Commission Delegated Regulation (EU) 2017/584 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying organisational requirements of trading venues (23) is to be incorporated into the EEA Agreement.

| (24) | Commission Delegated Regulation (EU) 2017/585 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the data standards and formats for financial instrument reference data and technical measures in relation to arrangements to be made by the European Securities and Markets Authority and competent authorities (24) is to be incorporated into the EEA Agreement. |
| --- | --- |

(24)

Commission Delegated Regulation (EU) 2017/585 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the data standards and formats for financial instrument reference data and technical measures in relation to arrangements to be made by the European Securities and Markets Authority and competent authorities (24) is to be incorporated into the EEA Agreement.

| (25) | Commission Delegated Regulation (EU) 2017/586 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the exchange of information between competent authorities when cooperating in supervisory activities, on-the-spot verifications and investigations (25) is to be incorporated into the EEA Agreement. |
| --- | --- |

(25)

Commission Delegated Regulation (EU) 2017/586 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the exchange of information between competent authorities when cooperating in supervisory activities, on-the-spot verifications and investigations (25) is to be incorporated into the EEA Agreement.

| (26) | Commission Delegated Regulation (EU) 2017/587 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of shares, depositary receipts, exchange-traded funds, certificates and other similar financial instruments and on transaction execution obligations in respect of certain shares on a trading venue or by a systematic internaliser (26) is to be incorporated into the EEA Agreement. |
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(26)

Commission Delegated Regulation (EU) 2017/587 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of shares, depositary receipts, exchange-traded funds, certificates and other similar financial instruments and on transaction execution obligations in respect of certain shares on a trading venue or by a systematic internaliser (26) is to be incorporated into the EEA Agreement.

| (27) | Commission Delegated Regulation (EU) 2017/588 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the tick size regime for shares, depositary receipts and exchange-traded funds (27) is to be incorporated into the EEA Agreement. |
| --- | --- |

(27)

Commission Delegated Regulation (EU) 2017/588 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the tick size regime for shares, depositary receipts and exchange-traded funds (27) is to be incorporated into the EEA Agreement.

| (28) | Commission Delegated Regulation (EU) 2017/589 of 19 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the organisational requirements of investment firms engaged in algorithmic trading (28) is to be incorporated into the EEA Agreement. |
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(28)

Commission Delegated Regulation (EU) 2017/589 of 19 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the organisational requirements of investment firms engaged in algorithmic trading (28) is to be incorporated into the EEA Agreement.

| (29) | Commission Delegated Regulation (EU) 2017/590 of 28 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the reporting of transactions to competent authorities (29) is to be incorporated into the EEA Agreement. |
| --- | --- |

(29)

Commission Delegated Regulation (EU) 2017/590 of 28 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the reporting of transactions to competent authorities (29) is to be incorporated into the EEA Agreement.

| (30) | Commission Delegated Regulation (EU) 2017/591 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the application of position limits to commodity derivatives (30) is to be incorporated into the EEA Agreement. |
| --- | --- |

(30)

Commission Delegated Regulation (EU) 2017/591 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the application of position limits to commodity derivatives (30) is to be incorporated into the EEA Agreement.

| (31) | Commission Delegated Regulation (EU) 2017/592 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the criteria to establish when an activity is considered to be ancillary to the main business (31) is to be incorporated into the EEA Agreement. |
| --- | --- |

(31)

Commission Delegated Regulation (EU) 2017/592 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the criteria to establish when an activity is considered to be ancillary to the main business (31) is to be incorporated into the EEA Agreement.

| (32) | Commission Delegated Regulation (EU) 2017/1018 of 29 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying information to be notified by investment firms, market operators and credit institutions (32), as corrected by OJ L 292, 10.11.2017, p. 119, is to be incorporated into the EEA Agreement. |
| --- | --- |

(32)

Commission Delegated Regulation (EU) 2017/1018 of 29 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying information to be notified by investment firms, market operators and credit institutions (32), as corrected by OJ L 292, 10.11.2017, p. 119, is to be incorporated into the EEA Agreement.

| (33) | Commission Delegated Regulation (EU) 2017/1799 of 12 June 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council as regards the exemption of certain third countries central banks in their performance of monetary, foreign exchange and financial stability policies from pre- and post-trade transparency requirements (33) is to be incorporated into the EEA Agreement. |
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(33)

Commission Delegated Regulation (EU) 2017/1799 of 12 June 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council as regards the exemption of certain third countries central banks in their performance of monetary, foreign exchange and financial stability policies from pre- and post-trade transparency requirements (33) is to be incorporated into the EEA Agreement.

| (34) | Commission Delegated Regulation (EU) 2017/1943 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on information and requirements for the authorisation of investment firms (34) is to be incorporated into the EEA Agreement. |
| --- | --- |

(34)

Commission Delegated Regulation (EU) 2017/1943 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on information and requirements for the authorisation of investment firms (34) is to be incorporated into the EEA Agreement.

| (35) | Commission Delegated Regulation (EU) 2017/1946 of 11 July 2017 supplementing Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (35) is to be incorporated into the EEA Agreement. |
| --- | --- |

(35)

Commission Delegated Regulation (EU) 2017/1946 of 11 July 2017 supplementing Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (35) is to be incorporated into the EEA Agreement.

| (36) | Commission Delegated Regulation (EU) 2017/2154 of 22 September 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on indirect clearing arrangements (36) is to be incorporated into the EEA Agreement. |
| --- | --- |

(36)

Commission Delegated Regulation (EU) 2017/2154 of 22 September 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on indirect clearing arrangements (36) is to be incorporated into the EEA Agreement.

| (37) | Commission Delegated Regulation (EU) 2017/2194 of 14 August 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to package orders (37) is to be incorporated into the EEA Agreement. |
| --- | --- |

(37)

Commission Delegated Regulation (EU) 2017/2194 of 14 August 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to package orders (37) is to be incorporated into the EEA Agreement.

| (38) | Commission Delegated Regulation (EU) 2017/2417 of 17 November 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the trading obligation for certain derivatives (38) is to be incorporated into the EEA Agreement. |
| --- | --- |

(38)

Commission Delegated Regulation (EU) 2017/2417 of 17 November 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the trading obligation for certain derivatives (38) is to be incorporated into the EEA Agreement.

| (39) | Commission Delegated Regulation (EU) 2018/63 of 26 September 2017 amending Delegated Regulation (EU) 2017/571 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (39) is to be incorporated into the EEA Agreement. |
| --- | --- |

(39)

Commission Delegated Regulation (EU) 2018/63 of 26 September 2017 amending Delegated Regulation (EU) 2017/571 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (39) is to be incorporated into the EEA Agreement.

| (40) | Commission Implementing Regulation (EU) 2016/824 of 25 May 2016 laying down implementing technical standards with regard to the content and format of the description of the functioning of multilateral trading facilities and organised trading facilities and the notification to the European Securities and Markets Authority according to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (40) is to be incorporated into the EEA Agreement. |
| --- | --- |

(40)

Commission Implementing Regulation (EU) 2016/824 of 25 May 2016 laying down implementing technical standards with regard to the content and format of the description of the functioning of multilateral trading facilities and organised trading facilities and the notification to the European Securities and Markets Authority according to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (40) is to be incorporated into the EEA Agreement.

| (41) | Commission Implementing Regulation (EU) 2017/953 of 6 June 2017 laying down implementing technical standards with regard to the format and the timing of position reports by investment firms and market operators of trading venues pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (41) is to be incorporated into the EEA Agreement. |
| --- | --- |

(41)

Commission Implementing Regulation (EU) 2017/953 of 6 June 2017 laying down implementing technical standards with regard to the format and the timing of position reports by investment firms and market operators of trading venues pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (41) is to be incorporated into the EEA Agreement.

| (42) | Commission Implementing Regulation (EU) 2017/980 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation in supervisory activities, for on-site verifications, and investigations and exchange of information between competent authorities in accordance with Directive 2014/65/EU of the European Parliament and of the Council (42) is to be incorporated into the EEA Agreement. |
| --- | --- |

(42)

Commission Implementing Regulation (EU) 2017/980 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation in supervisory activities, for on-site verifications, and investigations and exchange of information between competent authorities in accordance with Directive 2014/65/EU of the European Parliament and of the Council (42) is to be incorporated into the EEA Agreement.

| (43) | Commission Implementing Regulation (EU) 2017/981 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation of other competent authorities prior to granting an authorisation in accordance with Directive 2014/65/EU of the European Parliament and of the Council (43) is to be incorporated into the EEA Agreement. |
| --- | --- |

(43)

Commission Implementing Regulation (EU) 2017/981 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation of other competent authorities prior to granting an authorisation in accordance with Directive 2014/65/EU of the European Parliament and of the Council (43) is to be incorporated into the EEA Agreement.

| (44) | Commission Implementing Regulation (EU) 2017/988 of 6 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation arrangements in respect of a trading venue whose operations are of substantial importance in a host Member State (44) is to be incorporated into the EEA Agreement. |
| --- | --- |

(44)

Commission Implementing Regulation (EU) 2017/988 of 6 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation arrangements in respect of a trading venue whose operations are of substantial importance in a host Member State (44) is to be incorporated into the EEA Agreement.

| (45) | Commission Implementing Regulation (EU) 2017/1005 of 15 June 2017 laying down implementing technical standards with regard to the format and timing of the communications and the publication of the suspension and removal of financial instruments pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (45) is to be incorporated into the EEA Agreement. |
| --- | --- |

(45)

Commission Implementing Regulation (EU) 2017/1005 of 15 June 2017 laying down implementing technical standards with regard to the format and timing of the communications and the publication of the suspension and removal of financial instruments pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (45) is to be incorporated into the EEA Agreement.

| (46) | Commission Implementing Regulation (EU) 2017/1093 of 20 June 2017 laying down implementing technical standards with regard to the format of position reports by investment firms and market operators (46) is to be incorporated into the EEA Agreement. |
| --- | --- |

(46)

Commission Implementing Regulation (EU) 2017/1093 of 20 June 2017 laying down implementing technical standards with regard to the format of position reports by investment firms and market operators (46) is to be incorporated into the EEA Agreement.

| (47) | Commission Implementing Regulation (EU) 2017/1110 of 22 June 2017 laying down implementing technical standards with regard to the standard forms, templates and procedures for the authorisation of data reporting services providers and related notifications pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (47) is to be incorporated into the EEA Agreement. |
| --- | --- |

(47)

Commission Implementing Regulation (EU) 2017/1110 of 22 June 2017 laying down implementing technical standards with regard to the standard forms, templates and procedures for the authorisation of data reporting services providers and related notifications pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (47) is to be incorporated into the EEA Agreement.

| (48) | Commission Implementing Regulation (EU) 2017/1111 of 22 June 2017 laying down implementing technical standards with regard to procedures and forms for submitting information on sanctions and measures in accordance with Directive 2014/65/EU of the European Parliament and of the Council (48) is to be incorporated into the EEA Agreement. |
| --- | --- |

(48)

Commission Implementing Regulation (EU) 2017/1111 of 22 June 2017 laying down implementing technical standards with regard to procedures and forms for submitting information on sanctions and measures in accordance with Directive 2014/65/EU of the European Parliament and of the Council (48) is to be incorporated into the EEA Agreement.

| (49) | Commission Implementing Regulation (EU) 2017/1944 of 13 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation process between relevant competent authorities in relation to the notification of a proposed acquisition of a qualifying holding in an investment firm in accordance with Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council (49) is to be incorporated into the EEA Agreement. |
| --- | --- |

(49)

Commission Implementing Regulation (EU) 2017/1944 of 13 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation process between relevant competent authorities in relation to the notification of a proposed acquisition of a qualifying holding in an investment firm in accordance with Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council (49) is to be incorporated into the EEA Agreement.

| (50) | Commission Implementing Regulation (EU) 2017/1945 of 19 June 2017 laying down implementing technical standards with regard to notifications by and to applicant and authorised investment firms according to Directive 2014/65/EU of the European Parliament and of the Council (50) is to be incorporated into the EEA Agreement. |
| --- | --- |

(50)

Commission Implementing Regulation (EU) 2017/1945 of 19 June 2017 laying down implementing technical standards with regard to notifications by and to applicant and authorised investment firms according to Directive 2014/65/EU of the European Parliament and of the Council (50) is to be incorporated into the EEA Agreement.

| (51) | Commission Implementing Regulation (EU) 2017/2382 of 14 December 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the transmission of information in accordance with Directive 2014/65/EU of the European Parliament and of the Council (51), as corrected by OJ L 33, 7.2.2018, p. 5, is to be incorporated into the EEA Agreement. |
| --- | --- |

(51)

Commission Implementing Regulation (EU) 2017/2382 of 14 December 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the transmission of information in accordance with Directive 2014/65/EU of the European Parliament and of the Council (51), as corrected by OJ L 33, 7.2.2018, p. 5, is to be incorporated into the EEA Agreement.

| (52) | Commission Delegated Directive (EU) 2017/593 of 7 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to safeguarding of financial instruments and funds belonging to clients, product governance obligations and the rules applicable to the provision or reception of fees, commissions or any monetary or non-monetary benefits (52) is to be incorporated into the EEA Agreement. |
| --- | --- |

(52)

Commission Delegated Directive (EU) 2017/593 of 7 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to safeguarding of financial instruments and funds belonging to clients, product governance obligations and the rules applicable to the provision or reception of fees, commissions or any monetary or non-monetary benefits (52) is to be incorporated into the EEA Agreement.

| (53) | Commission Implementing Decision (EU) 2017/2238 of 5 December 2017 on the equivalence of the legal and supervisory framework applicable to designated contract markets and swap execution facilities in the United States of America in accordance with Regulation (EU) No 600/2014 of the European Parliament and of the Council (53) is to be incorporated into the EEA Agreement. |
| --- | --- |

(53)

Commission Implementing Decision (EU) 2017/2238 of 5 December 2017 on the equivalence of the legal and supervisory framework applicable to designated contract markets and swap execution facilities in the United States of America in accordance with Regulation (EU) No 600/2014 of the European Parliament and of the Council (53) is to be incorporated into the EEA Agreement.

| (54) | Commission Implementing Decision (EU) 2017/2318 of 13 December 2017 on the equivalence of the legal and supervisory framework in Australia applicable to financial markets in accordance with Directive 2014/65/EU of the European Parliament and of the Council (54) is to be incorporated into the EEA Agreement. |
| --- | --- |

(54)

Commission Implementing Decision (EU) 2017/2318 of 13 December 2017 on the equivalence of the legal and supervisory framework in Australia applicable to financial markets in accordance with Directive 2014/65/EU of the European Parliament and of the Council (54) is to be incorporated into the EEA Agreement.

| (55) | Commission Implementing Decision (EU) 2017/2319 of 13 December 2017 on the equivalence of the legal and supervisory framework applicable to recognised exchange companies in Hong Kong Special Administrative Region in accordance with Directive 2014/65/EU of the European Parliament and of the Council (55) is to be incorporated into the EEA Agreement. |
| --- | --- |

(55)

Commission Implementing Decision (EU) 2017/2319 of 13 December 2017 on the equivalence of the legal and supervisory framework applicable to recognised exchange companies in Hong Kong Special Administrative Region in accordance with Directive 2014/65/EU of the European Parliament and of the Council (55) is to be incorporated into the EEA Agreement.

| (56) | Commission Implementing Decision (EU) 2017/2320 of 13 December 2017 on the equivalence of the legal and supervisory framework of the United States of America for national securities exchanges and alternative trading systems in accordance with Directive 2014/65/EU of the European Parliament and of the Council (56) is to be incorporated into the EEA Agreement. |
| --- | --- |

(56)

Commission Implementing Decision (EU) 2017/2320 of 13 December 2017 on the equivalence of the legal and supervisory framework of the United States of America for national securities exchanges and alternative trading systems in accordance with Directive 2014/65/EU of the European Parliament and of the Council (56) is to be incorporated into the EEA Agreement.

| (57) | Commission Implementing Decision (EU) 2017/2441 of 21 December 2017 on the equivalence of the legal and supervisory framework applicable to stock exchanges in Switzerland in accordance with Directive 2014/65/EU of the European Parliament and of the Council (57) is to be incorporated into the EEA Agreement. |
| --- | --- |

(57)

Commission Implementing Decision (EU) 2017/2441 of 21 December 2017 on the equivalence of the legal and supervisory framework applicable to stock exchanges in Switzerland in accordance with Directive 2014/65/EU of the European Parliament and of the Council (57) is to be incorporated into the EEA Agreement.

| (58) | Annex IX to the EEA Agreement should therefore be amended accordingly, |
| --- | --- |

(58)

Annex IX to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following is added after point 31baa (Regulation (EU) No 600/2014 of the European Parliament and of the Council) of Annex IX to the EEA Agreement:

| ‘31bad. | 32016 R 0824: Commission Implementing Regulation (EU) 2016/824 of 25 May 2016 laying down implementing technical standards with regard to the content and format of the description of the functioning of multilateral trading facilities and organised trading facilities and the notification to the European Securities and Markets Authority according to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 137, 26.5.2016, p. 10). |
| --- | --- |

‘31bad.

32016 R 0824: Commission Implementing Regulation (EU) 2016/824 of 25 May 2016 laying down implementing technical standards with regard to the content and format of the description of the functioning of multilateral trading facilities and organised trading facilities and the notification to the European Securities and Markets Authority according to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 137, 26.5.2016, p. 10).

| 31bae. | 32016 R 2020: Commission Delegated Regulation (EU) 2016/2020 of 26 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on criteria for determining whether derivatives subject to the clearing obligation should be subject to the trading obligation (OJ L 313, 19.11.2016, p. 2). |
| --- | --- |

31bae.

32016 R 2020: Commission Delegated Regulation (EU) 2016/2020 of 26 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on criteria for determining whether derivatives subject to the clearing obligation should be subject to the trading obligation (OJ L 313, 19.11.2016, p. 2).

| 31baf. | 32016 R 2021: Commission Delegated Regulation (EU) 2016/2021 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on access in respect of benchmarks (OJ L 313, 19.11.2016, p. 6). |
| --- | --- |

31baf.

32016 R 2021: Commission Delegated Regulation (EU) 2016/2021 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on access in respect of benchmarks (OJ L 313, 19.11.2016, p. 6).

| 31bag. | 32016 R 2022: Commission Delegated Regulation (EU) 2016/2022 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards concerning the information for registration of third-country firms and the format of information to be provided to the clients (OJ L 313, 19.11.2016, p. 11). |
| --- | --- |

31bag.

32016 R 2022: Commission Delegated Regulation (EU) 2016/2022 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards concerning the information for registration of third-country firms and the format of information to be provided to the clients (OJ L 313, 19.11.2016, p. 11).

| 31bah. | 32017 R 0565: Commission Delegated Regulation (EU) 2017/565 of 25 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive (OJ L 87, 31.3.2017, p. 1).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:






  (a) | References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- | --- |

31bah.

32017 R 0565: Commission Delegated Regulation (EU) 2017/565 of 25 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council as regards organisational requirements and operating conditions for investment firms and defined terms for the purposes of that Directive (OJ L 87, 31.3.2017, p. 1).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (b) | In paragraph 3 of Article 10, the words “, Icelandic króna” shall be inserted after the word “Polish złoty” |
| --- | --- |

(b)

In paragraph 3 of Article 10, the words “, Icelandic króna” shall be inserted after the word “Polish złoty”

| (c) | In paragraphs 5 and 6 of Article 50, the words “Union legislation” shall be replaced by the words “provisions of the EEA Agreement”. |
| --- | --- |

(c)

In paragraphs 5 and 6 of Article 50, the words “Union legislation” shall be replaced by the words “provisions of the EEA Agreement”.

| 31bai. | 32017 R 0566: Commission Delegated Regulation (EU) 2017/566 of 18 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the ratio of unexecuted orders to transactions in order to prevent disorderly trading conditions (OJ L 87, 31.3.2017, p. 84). |
| --- | --- |

31bai.

32017 R 0566: Commission Delegated Regulation (EU) 2017/566 of 18 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the ratio of unexecuted orders to transactions in order to prevent disorderly trading conditions (OJ L 87, 31.3.2017, p. 84).

| 31baj. | 32017 R 0567: Commission Delegated Regulation (EU) 2017/567 of 18 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to definitions, transparency, portfolio compression and supervisory measures on product intervention and positions (OJ L 87, 31.3.2017, p. 90).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:






  (a) | References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- | --- |

31baj.

32017 R 0567: Commission Delegated Regulation (EU) 2017/567 of 18 May 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to definitions, transparency, portfolio compression and supervisory measures on product intervention and positions (OJ L 87, 31.3.2017, p. 90).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (b) | In Articles 19 and 22 the words “or as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(b)

In Articles 19 and 22 the words “or as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (c) | In Article 20, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “EBA”. |
| --- | --- |

(c)

In Article 20, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “EBA”.

| 31bak. | 32017 R 0568: Commission Delegated Regulation (EU) 2017/568 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the admission of financial instruments to trading on regulated markets (OJ L 87, 31.3.2017, p. 117).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
  In Article 7, the words “Union law” shall be replaced by “the EEA Agreement”. |
| --- | --- |

31bak.

32017 R 0568: Commission Delegated Regulation (EU) 2017/568 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the admission of financial instruments to trading on regulated markets (OJ L 87, 31.3.2017, p. 117).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

In Article 7, the words “Union law” shall be replaced by “the EEA Agreement”.

| 31bal. | 32017 R 0569: Commission Delegated Regulation (EU) 2017/569 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the suspension and removal of financial instruments from trading (OJ L 87, 31.3.2017, p. 122). |
| --- | --- |

31bal.

32017 R 0569: Commission Delegated Regulation (EU) 2017/569 of 24 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the suspension and removal of financial instruments from trading (OJ L 87, 31.3.2017, p. 122).

| 31bam. | 32017 R 0570: Commission Delegated Regulation (EU) 2017/570 of 26 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the determination of a material market in terms of liquidity in relation to notifications of a temporary halt in trading (OJ L 87, 31.3.2017, p. 124). |
| --- | --- |

31bam.

32017 R 0570: Commission Delegated Regulation (EU) 2017/570 of 26 May 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards for the determination of a material market in terms of liquidity in relation to notifications of a temporary halt in trading (OJ L 87, 31.3.2017, p. 124).

| 31ban. | 32017 R 0571: Commission Delegated Regulation (EU) 2017/571 of 2 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (OJ L 87, 31.3.2017, p. 126), as amended by:








  32018 R 0063: Commission Delegated Regulation (EU) 2018/63 of 26 September 2017 (OJ L 12, 17.1.2018, p. 2). |
| --- | --- |

31ban.

32017 R 0571: Commission Delegated Regulation (EU) 2017/571 of 2 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the authorisation, organisational requirements and the publication of transactions for data reporting services providers (OJ L 87, 31.3.2017, p. 126), as amended by:

32018 R 0063: Commission Delegated Regulation (EU) 2018/63 of 26 September 2017 (OJ L 12, 17.1.2018, p. 2).

| 31bao. | 32017 R 0572: Commission Delegated Regulation (EU) 2017/572 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on the specification of the offering of pre-and post-trade data and the level of disaggregation of data (OJ L 87, 31.3.2017, p. 142). |
| --- | --- |

31bao.

32017 R 0572: Commission Delegated Regulation (EU) 2017/572 of 2 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on the specification of the offering of pre-and post-trade data and the level of disaggregation of data (OJ L 87, 31.3.2017, p. 142).

| 31bap. | 32017 R 0573: Commission Delegated Regulation (EU) 2017/573 of 6 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on requirements to ensure fair and non-discriminatory co-location services and fee structures (OJ L 87, 31.3.2017, p. 145). |
| --- | --- |

31bap.

32017 R 0573: Commission Delegated Regulation (EU) 2017/573 of 6 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on requirements to ensure fair and non-discriminatory co-location services and fee structures (OJ L 87, 31.3.2017, p. 145).

| 31baq. | 32017 R 0574: Commission Delegated Regulation (EU) 2017/574 of 7 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the level of accuracy of business clocks (OJ L 87, 31.3.2017, p. 148). |
| --- | --- |

31baq.

32017 R 0574: Commission Delegated Regulation (EU) 2017/574 of 7 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the level of accuracy of business clocks (OJ L 87, 31.3.2017, p. 148).

| 31bar. | 32017 R 0575: Commission Delegated Regulation (EU) 2017/575 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards concerning the data to be published by execution venues on the quality of execution of transactions (OJ L 87, 31.3.2017, p. 152). |
| --- | --- |

31bar.

32017 R 0575: Commission Delegated Regulation (EU) 2017/575 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards concerning the data to be published by execution venues on the quality of execution of transactions (OJ L 87, 31.3.2017, p. 152).

| 31bas. | 32017 R 0576: Commission Delegated Regulation (EU) 2017/576 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the annual publication by investment firms of information on the identity of execution venues and on the quality of execution (OJ L 87, 31.3.2017, p. 166). |
| --- | --- |

31bas.

32017 R 0576: Commission Delegated Regulation (EU) 2017/576 of 8 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the annual publication by investment firms of information on the identity of execution venues and on the quality of execution (OJ L 87, 31.3.2017, p. 166).

| 31bat. | 32017 R 0577: Commission Delegated Regulation (EU) 2017/577 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the volume cap mechanism and the provision of information for the purposes of transparency and other calculations (OJ L 87, 31.3.2017, p. 174). |
| --- | --- |

31bat.

32017 R 0577: Commission Delegated Regulation (EU) 2017/577 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the volume cap mechanism and the provision of information for the purposes of transparency and other calculations (OJ L 87, 31.3.2017, p. 174).

| 31bau. | 32017 R 0578: Commission Delegated Regulation (EU) 2017/578 of 13 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying the requirements on market making agreements and schemes (OJ L 87, 31.3.2017, p. 183). |
| --- | --- |

31bau.

32017 R 0578: Commission Delegated Regulation (EU) 2017/578 of 13 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying the requirements on market making agreements and schemes (OJ L 87, 31.3.2017, p. 183).

| 31bav. | 32017 R 0579: Commission Delegated Regulation (EU) 2017/579 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the direct, substantial and foreseeable effect of derivative contracts within the Union and the prevention of the evasion of rules and obligations (OJ L 87, 31.3.2017, p. 189). |
| --- | --- |

31bav.

32017 R 0579: Commission Delegated Regulation (EU) 2017/579 of 13 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the direct, substantial and foreseeable effect of derivative contracts within the Union and the prevention of the evasion of rules and obligations (OJ L 87, 31.3.2017, p. 189).

| 31baw. | 32017 R 0580: Commission Delegated Regulation (EU) 2017/580 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the maintenance of relevant data relating to orders in financial instruments (OJ L 87, 31.3.2017, p. 193). |
| --- | --- |

31baw.

32017 R 0580: Commission Delegated Regulation (EU) 2017/580 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the maintenance of relevant data relating to orders in financial instruments (OJ L 87, 31.3.2017, p. 193).

| 31bax. | 32017 R 0581: Commission Delegated Regulation (EU) 2017/581 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on clearing access in respect of trading venues and central counterparties (OJ L 87, 31.3.2017, p. 212).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:






  (a) | In Articles 16, 17, 18 and 20(1), as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”. |
| --- | --- | --- |

31bax.

32017 R 0581: Commission Delegated Regulation (EU) 2017/581 of 24 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on clearing access in respect of trading venues and central counterparties (OJ L 87, 31.3.2017, p. 212).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

In Articles 16, 17, 18 and 20(1), as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”.

| (b) | In Article 20(2) the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(b)

In Article 20(2) the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (c) | In Article 20(3) the words “or, as regards the EFTA states, the EFTA Surveillance Authority on the basis of a draft prepared by ESMA” shall be inserted after the word “ESMA”. |
| --- | --- |

(c)

In Article 20(3) the words “or, as regards the EFTA states, the EFTA Surveillance Authority on the basis of a draft prepared by ESMA” shall be inserted after the word “ESMA”.

| 31bay. | 32017 R 0582: Commission Delegated Regulation (EU) 2017/582 of 29 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards specifying the obligation to clear derivatives traded on regulated markets and timing of acceptance for clearing (OJ L 87, 31.3.2017, p. 224). |
| --- | --- |

31bay.

32017 R 0582: Commission Delegated Regulation (EU) 2017/582 of 29 June 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards specifying the obligation to clear derivatives traded on regulated markets and timing of acceptance for clearing (OJ L 87, 31.3.2017, p. 224).

| 31baz. | 32017 R 0583: Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives (OJ L 87, 31.3.2017, p. 229).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:
  References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States. |
| --- | --- |

31baz.

32017 R 0583: Commission Delegated Regulation (EU) 2017/583 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of bonds, structured finance products, emission allowances and derivatives (OJ L 87, 31.3.2017, p. 229).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptation:

References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States.

| 31baza. | 32017 R 0584: Commission Delegated Regulation (EU) 2017/584 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying organisational requirements of trading venues (OJ L 87, 31.3.2017, p. 350). |
| --- | --- |

31baza.

32017 R 0584: Commission Delegated Regulation (EU) 2017/584 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying organisational requirements of trading venues (OJ L 87, 31.3.2017, p. 350).

| 31bazb. | 32017 R 0585: Commission Delegated Regulation (EU) 2017/585 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the data standards and formats for financial instrument reference data and technical measures in relation to arrangements to be made by the European Securities and Markets Authority and competent authorities (OJ L 87, 31.3.2017, p. 368). |
| --- | --- |

31bazb.

32017 R 0585: Commission Delegated Regulation (EU) 2017/585 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the data standards and formats for financial instrument reference data and technical measures in relation to arrangements to be made by the European Securities and Markets Authority and competent authorities (OJ L 87, 31.3.2017, p. 368).

| 31bazc. | 32017 R 0586: Commission Delegated Regulation (EU) 2017/586 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the exchange of information between competent authorities when cooperating in supervisory activities, on-the-spot verifications and investigations (OJ L 87, 31.3.2017, p. 382). |
| --- | --- |

31bazc.

32017 R 0586: Commission Delegated Regulation (EU) 2017/586 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the exchange of information between competent authorities when cooperating in supervisory activities, on-the-spot verifications and investigations (OJ L 87, 31.3.2017, p. 382).

| 31bazd. | 32017 R 0587: Commission Delegated Regulation (EU) 2017/587 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of shares, depositary receipts, exchange-traded funds, certificates and other similar financial instruments and on transaction execution obligations in respect of certain shares on a trading venue or by a systematic internaliser (OJ L 87, 31.3.2017, p. 387). |
| --- | --- |

31bazd.

32017 R 0587: Commission Delegated Regulation (EU) 2017/587 of 14 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on transparency requirements for trading venues and investment firms in respect of shares, depositary receipts, exchange-traded funds, certificates and other similar financial instruments and on transaction execution obligations in respect of certain shares on a trading venue or by a systematic internaliser (OJ L 87, 31.3.2017, p. 387).

| 31baze. | 32017 R 0588: Commission Delegated Regulation (EU) 2017/588 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the tick size regime for shares, depositary receipts and exchange-traded funds (OJ L 87, 31.3.2017, p. 411). |
| --- | --- |

31baze.

32017 R 0588: Commission Delegated Regulation (EU) 2017/588 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on the tick size regime for shares, depositary receipts and exchange-traded funds (OJ L 87, 31.3.2017, p. 411).

| 31bazf. | 32017 R 0589: Commission Delegated Regulation (EU) 2017/589 of 19 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the organisational requirements of investment firms engaged in algorithmic trading (OJ L 87, 31.3.2017, p. 417). |
| --- | --- |

31bazf.

32017 R 0589: Commission Delegated Regulation (EU) 2017/589 of 19 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards specifying the organisational requirements of investment firms engaged in algorithmic trading (OJ L 87, 31.3.2017, p. 417).

| 31bazg. | 32017 R 0590: Commission Delegated Regulation (EU) 2017/590 of 28 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the reporting of transactions to competent authorities (OJ L 87, 31.3.2017, p. 449).
  The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:






  (a) | References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States. |
| --- | --- | --- |

31bazg.

32017 R 0590: Commission Delegated Regulation (EU) 2017/590 of 28 July 2016 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards for the reporting of transactions to competent authorities (OJ L 87, 31.3.2017, p. 449).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

(a)

References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States.

| (b) | In Annex II, the entry for Liechtenstein shall be replaced by the following:









  LI | Liechtenstein | CONCAT | | |
| --- | --- | --- | --- | --- | --- |

(b)

In Annex II, the entry for Liechtenstein shall be replaced by the following:

LI

Liechtenstein

CONCAT

| 31bazh. | 32017 R 0591: Commission Delegated Regulation (EU) 2017/591 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the application of position limits to commodity derivatives (OJ L 87, 31.3.2017, p. 479). |
| --- | --- |

31bazh.

32017 R 0591: Commission Delegated Regulation (EU) 2017/591 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the application of position limits to commodity derivatives (OJ L 87, 31.3.2017, p. 479).

| 31bazi. | 32017 R 0592: Commission Delegated Regulation (EU) 2017/592 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the criteria to establish when an activity is considered to be ancillary to the main business (OJ L 87, 31.3.2017, p. 492). |
| --- | --- |

31bazi.

32017 R 0592: Commission Delegated Regulation (EU) 2017/592 of 1 December 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for the criteria to establish when an activity is considered to be ancillary to the main business (OJ L 87, 31.3.2017, p. 492).

| 31bazj. | 32017 L 0593: Commission Delegated Directive (EU) 2017/593 of 7 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to safeguarding of financial instruments and funds belonging to clients, product governance obligations and the rules applicable to the provision or reception of fees, commissions or any monetary or non-monetary benefits (OJ L 87, 31.3.2017, p. 500). |
| --- | --- |

31bazj.

32017 L 0593: Commission Delegated Directive (EU) 2017/593 of 7 April 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to safeguarding of financial instruments and funds belonging to clients, product governance obligations and the rules applicable to the provision or reception of fees, commissions or any monetary or non-monetary benefits (OJ L 87, 31.3.2017, p. 500).

| 31bazk. | 32017 R 0953: Commission Implementing Regulation (EU) 2017/953 of 6 June 2017 laying down implementing technical standards with regard to the format and the timing of position reports by investment firms and market operators of trading venues pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 144, 7.6.2017, p. 12). |
| --- | --- |

31bazk.

32017 R 0953: Commission Implementing Regulation (EU) 2017/953 of 6 June 2017 laying down implementing technical standards with regard to the format and the timing of position reports by investment firms and market operators of trading venues pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 144, 7.6.2017, p. 12).

| 31bazl. | 32017 R 0980: Commission Implementing Regulation (EU) 2017/980 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation in supervisory activities, for on-site verifications, and investigations and exchange of information between competent authorities in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 148, 10.6.2017, p. 3). |
| --- | --- |

31bazl.

32017 R 0980: Commission Implementing Regulation (EU) 2017/980 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation in supervisory activities, for on-site verifications, and investigations and exchange of information between competent authorities in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 148, 10.6.2017, p. 3).

| 31bazm. | 32017 R 0981: Commission Implementing Regulation (EU) 2017/981 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation of other competent authorities prior to granting an authorisation in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 148, 10.6.2017, p. 16). |
| --- | --- |

31bazm.

32017 R 0981: Commission Implementing Regulation (EU) 2017/981 of 7 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation of other competent authorities prior to granting an authorisation in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 148, 10.6.2017, p. 16).

| 31bazn. | 32017 R 0988: Commission Implementing Regulation (EU) 2017/988 of 6 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation arrangements in respect of a trading venue whose operations are of substantial importance in a host Member State (OJ L 149, 13.6.2017, p. 3). |
| --- | --- |

31bazn.

32017 R 0988: Commission Implementing Regulation (EU) 2017/988 of 6 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for cooperation arrangements in respect of a trading venue whose operations are of substantial importance in a host Member State (OJ L 149, 13.6.2017, p. 3).

| 31bazo. | 32017 R 1005: Commission Implementing Regulation (EU) 2017/1005 of 15 June 2017 laying down implementing technical standards with regard to the format and timing of the communications and the publication of the suspension and removal of financial instruments pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 153, 16.6.2017, p. 1). |
| --- | --- |

31bazo.

32017 R 1005: Commission Implementing Regulation (EU) 2017/1005 of 15 June 2017 laying down implementing technical standards with regard to the format and timing of the communications and the publication of the suspension and removal of financial instruments pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 153, 16.6.2017, p. 1).

| 31bazp. | 32017 R 1018: Commission Delegated Regulation (EU) 2017/1018 of 29 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying information to be notified by investment firms, market operators and credit institutions (OJ L 155, 17.6.2017, p. 1), as corrected by OJ L 292, 10.11.2017, p. 119. |
| --- | --- |

31bazp.

32017 R 1018: Commission Delegated Regulation (EU) 2017/1018 of 29 June 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards specifying information to be notified by investment firms, market operators and credit institutions (OJ L 155, 17.6.2017, p. 1), as corrected by OJ L 292, 10.11.2017, p. 119.

| 31bazq. | 32017 R 1093: Commission Implementing Regulation (EU) 2017/1093 of 20 June 2017 laying down implementing technical standards with regard to the format of position reports by investment firms and market operators (OJ L 158, 21.6.2017, p. 16). |
| --- | --- |

31bazq.

32017 R 1093: Commission Implementing Regulation (EU) 2017/1093 of 20 June 2017 laying down implementing technical standards with regard to the format of position reports by investment firms and market operators (OJ L 158, 21.6.2017, p. 16).

| 31bazr. | 32017 R 1110: Commission Implementing Regulation (EU) 2017/1110 of 22 June 2017 laying down implementing technical standards with regard to the standard forms, templates and procedures for the authorisation of data reporting services providers and related notifications pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 162, 23.6.2017, p. 3). |
| --- | --- |

31bazr.

32017 R 1110: Commission Implementing Regulation (EU) 2017/1110 of 22 June 2017 laying down implementing technical standards with regard to the standard forms, templates and procedures for the authorisation of data reporting services providers and related notifications pursuant to Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments (OJ L 162, 23.6.2017, p. 3).

| 31bazs. | 32017 R 1111: Commission Implementing Regulation (EU) 2017/1111 of 22 June 2017 laying down implementing technical standards with regard to procedures and forms for submitting information on sanctions and measures in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 162, 23.6.2017, p. 14). |
| --- | --- |

31bazs.

32017 R 1111: Commission Implementing Regulation (EU) 2017/1111 of 22 June 2017 laying down implementing technical standards with regard to procedures and forms for submitting information on sanctions and measures in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 162, 23.6.2017, p. 14).

| 31bazt. | 32017 R 1799: Commission Delegated Regulation (EU) 2017/1799 of 12 June 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council as regards the exemption of certain third countries central banks in their performance of monetary, foreign exchange and financial stability policies from pre- and post-trade transparency requirements (OJ L 259, 7.10.2017, p. 11). |
| --- | --- |

31bazt.

32017 R 1799: Commission Delegated Regulation (EU) 2017/1799 of 12 June 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council as regards the exemption of certain third countries central banks in their performance of monetary, foreign exchange and financial stability policies from pre- and post-trade transparency requirements (OJ L 259, 7.10.2017, p. 11).

| 31bazu. | 32017 R 1943: Commission Delegated Regulation (EU) 2017/1943 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on information and requirements for the authorisation of investment firms (OJ L 276, 26.10.2017, p. 4). |
| --- | --- |

31bazu.

32017 R 1943: Commission Delegated Regulation (EU) 2017/1943 of 14 July 2016 supplementing Directive 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards on information and requirements for the authorisation of investment firms (OJ L 276, 26.10.2017, p. 4).

| 31bazv. | 32017 R 1944: Commission Implementing Regulation (EU) 2017/1944 of 13 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation process between relevant competent authorities in relation to the notification of a proposed acquisition of a qualifying holding in an investment firm in accordance with Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council (OJ L 276, 26.10.2017, p. 12). |
| --- | --- |

31bazv.

32017 R 1944: Commission Implementing Regulation (EU) 2017/1944 of 13 June 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the consultation process between relevant competent authorities in relation to the notification of a proposed acquisition of a qualifying holding in an investment firm in accordance with Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council (OJ L 276, 26.10.2017, p. 12).

| 31bazw. | 32017 R 1945: Commission Implementing Regulation (EU) 2017/1945 of 19 June 2017 laying down implementing technical standards with regard to notifications by and to applicant and authorised investment firms according to Directive 2014/65/EU of the European Parliament and of the Council (OJ L 276, 26.10.2017, p. 22). |
| --- | --- |

31bazw.

32017 R 1945: Commission Implementing Regulation (EU) 2017/1945 of 19 June 2017 laying down implementing technical standards with regard to notifications by and to applicant and authorised investment firms according to Directive 2014/65/EU of the European Parliament and of the Council (OJ L 276, 26.10.2017, p. 22).

| 31bazx. | 32017 R 1946: Commission Delegated Regulation (EU) 2017/1946 of 11 July 2017 supplementing Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (OJ L 276, 26.10.2017, p. 32). |
| --- | --- |

31bazx.

32017 R 1946: Commission Delegated Regulation (EU) 2017/1946 of 11 July 2017 supplementing Directives 2004/39/EC and 2014/65/EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (OJ L 276, 26.10.2017, p. 32).

| 31bazy. | 32017 R 2154: Commission Delegated Regulation (EU) 2017/2154 of 22 September 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on indirect clearing arrangements (OJ L 304, 21.11.2017, p. 6). |
| --- | --- |

31bazy.

32017 R 2154: Commission Delegated Regulation (EU) 2017/2154 of 22 September 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council with regard to regulatory technical standards on indirect clearing arrangements (OJ L 304, 21.11.2017, p. 6).

| 31bazz. | 32017 R 2194: Commission Delegated Regulation (EU) 2017/2194 of 14 August 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to package orders (OJ L 312, 28.11.2017, p. 1). |
| --- | --- |

31bazz.

32017 R 2194: Commission Delegated Regulation (EU) 2017/2194 of 14 August 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to package orders (OJ L 312, 28.11.2017, p. 1).

| 31bazza. | 32017 D 2238: Commission Implementing Decision (EU) 2017/2238 of 5 December 2017 on the equivalence of the legal and supervisory framework applicable to designated contract markets and swap execution facilities in the United States of America in accordance with Regulation (EU) No 600/2014 of the European Parliament and of the Council (OJ L 320, 6.12.2017, p. 11). |
| --- | --- |

31bazza.

32017 D 2238: Commission Implementing Decision (EU) 2017/2238 of 5 December 2017 on the equivalence of the legal and supervisory framework applicable to designated contract markets and swap execution facilities in the United States of America in accordance with Regulation (EU) No 600/2014 of the European Parliament and of the Council (OJ L 320, 6.12.2017, p. 11).

| 31bazzb. | 32017 D 2318: Commission Implementing Decision (EU) 2017/2318 of 13 December 2017 on the equivalence of the legal and supervisory framework in Australia applicable to financial markets in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 81). |
| --- | --- |

31bazzb.

32017 D 2318: Commission Implementing Decision (EU) 2017/2318 of 13 December 2017 on the equivalence of the legal and supervisory framework in Australia applicable to financial markets in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 81).

| 31bazzc. | 32017 D 2319: Commission Implementing Decision (EU) 2017/2319 of 13 December 2017 on the equivalence of the legal and supervisory framework applicable to recognised exchange companies in Hong Kong Special Administrative Region in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 87). |
| --- | --- |

31bazzc.

32017 D 2319: Commission Implementing Decision (EU) 2017/2319 of 13 December 2017 on the equivalence of the legal and supervisory framework applicable to recognised exchange companies in Hong Kong Special Administrative Region in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 87).

| 31bazzd. | 32017 D 2320: Commission Implementing Decision (EU) 2017/2320 of 13 December 2017 on the equivalence of the legal and supervisory framework of the United States of America for national securities exchanges and alternative trading systems in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 94). |
| --- | --- |

31bazzd.

32017 D 2320: Commission Implementing Decision (EU) 2017/2320 of 13 December 2017 on the equivalence of the legal and supervisory framework of the United States of America for national securities exchanges and alternative trading systems in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 331, 14.12.2017, p. 94).

| 31bazze. | 32017 R 2382: Commission Implementing Regulation (EU) 2017/2382 of 14 December 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the transmission of information in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 340, 20.12.2017, p. 6), as corrected by OJ L 33, 7.2.2018, p. 5. |
| --- | --- |

31bazze.

32017 R 2382: Commission Implementing Regulation (EU) 2017/2382 of 14 December 2017 laying down implementing technical standards with regard to standard forms, templates and procedures for the transmission of information in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 340, 20.12.2017, p. 6), as corrected by OJ L 33, 7.2.2018, p. 5.

| 31bazzf. | 32017 R 2417: Commission Delegated Regulation (EU) 2017/2417 of 17 November 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the trading obligation for certain derivatives (OJ L 343, 22.12.2017, p. 48). |
| --- | --- |

31bazzf.

32017 R 2417: Commission Delegated Regulation (EU) 2017/2417 of 17 November 2017 supplementing Regulation (EU) No 600/2014 of the European Parliament and of the Council on markets in financial instruments with regard to regulatory technical standards on the trading obligation for certain derivatives (OJ L 343, 22.12.2017, p. 48).

| 31bazzg. | 32017 D 2441: Commission Implementing Decision (EU) 2017/2441 of 21 December 2017 on the equivalence of the legal and supervisory framework applicable to stock exchanges in Switzerland in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 344, 23.12.2017, p. 52).’ |
| --- | --- |

31bazzg.

32017 D 2441: Commission Implementing Decision (EU) 2017/2441 of 21 December 2017 on the equivalence of the legal and supervisory framework applicable to stock exchanges in Switzerland in accordance with Directive 2014/65/EU of the European Parliament and of the Council (OJ L 344, 23.12.2017, p. 52).’

Article 2

The texts of Delegation Regulations (EU) 2016/2020, (EU) 2016/2021, (EU) 2016/2022, (EU) 2017/565, (EU) 2017/566, (EU) 2017/567, (EU) 2017/568, (EU) 2017/569, (EU) 2017/570, (EU) 2017/571, (EU) 2017/572, (EU) 2017/573, (EU) 2017/574, (EU) 2017/575, (EU) 2017/576, (EU) 2017/577, (EU) 2017/578, (EU) 2017/579, (EU) 2017/580, (EU) 2017/581, (EU) 2017/582, (EU) 2017/583, (EU) 2017/584, (EU) 2017/585, (EU) 2017/586, (EU) 2017/587, (EU) 2017/588, (EU) 2017/589, (EU) 2017/590, (EU) 2017/591, (EU) 2017/592, (EU) 2017/1018, (EU) 2017/1799, (EU) 2017/1943, (EU) 2017/1946, (EU) 2017/2154, (EU) 2017/2194, (EU) 2017/2417 and (EU) 2018/63, Implementing Regulations (EU) 2016/824, (EU) 2017/953, (EU) 2017/980, (EU) 2017/981, (EU) 2017/988, (EU) 2017/1005, (EU) 2017/1093, (EU) 2017/1110, (EU) 2017/1111, (EU) 2017/1944, (EU) 2017/1945 and (EU) 2017/2382, Delegated Directive (EU) 2017/593 and Implementing Decisions (EU) 2017/2238, (EU) 2017/2318, (EU) 2017/2319, (EU) 2017/2320 and (EU) 2017/2441 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on 30 March 2019, or on the day of the entry into force of Decision of the EEA Joint Committee No 78/2019 of 29 March 2019 (58), whichever is the later, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 29 March 2019.

For the EEA Joint Committee

The President

Claude MAERTEN

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(1)  
  OJ L 313, 19.11.2016, p. 2.

1

(2)  
  OJ L 313, 19.11.2016, p. 6.

2

(3)  
  OJ L 313, 19.11.2016, p. 11.

3

(4)  
  OJ L 87, 31.3.2017, p. 1.

4

(5)  
  OJ L 87, 31.3.2017, p. 84.

5

(6)  
  OJ L 87, 31.3.2017, p. 90.

6

(7)  
  OJ L 87, 31.3.2017, p. 117.

7

(8)  
  OJ L 87, 31.3.2017, p. 122.

8

(9)  
  OJ L 87, 31.3.2017, p. 124.

9

(10)  
  OJ L 87, 31.3.2017, p. 126.

10

(11)  
  OJ L 87, 31.3.2017, p. 142.

11

(12)  
  OJ L 87, 31.3.2017, p. 145.

12

(13)  
  OJ L 87, 31.3.2017, p. 148.

13

(14)  
  OJ L 87, 31.3.2017, p. 152.

14

(15)  
  OJ L 87, 31.3.2017, p. 166.

15

(16)  
  OJ L 87, 31.3.2017, p. 174.

16

(17)  
  OJ L 87, 31.3.2017, p. 183.

17

(18)  
  OJ L 87, 31.3.2017, p. 189.

18

(19)  
  OJ L 87, 31.3.2017, p. 193.

19

(20)  
  OJ L 87, 31.3.2017, p. 212.

20

(21)  
  OJ L 87, 31.3.2017, p. 224.

21

(22)  
  OJ L 87, 31.3.2017, p. 229.

22

(23)  
  OJ L 87, 31.3.2017, p. 350.

23

(24)  
  OJ L 87, 31.3.2017, p. 368.

24

(25)  
  OJ L 87, 31.3.2017, p. 382.

25

(26)  
  OJ L 87, 31.3.2017, p. 387.

26

(27)  
  OJ L 87, 31.3.2017, p. 411.

27

(28)  
  OJ L 87, 31.3.2017, p. 417.

28

(29)  
  OJ L 87, 31.3.2017, p. 449.

29

(30)  
  OJ L 87, 31.3.2017, p. 479.

30

(31)  
  OJ L 87, 31.3.2017, p. 492.

31

(32)  
  OJ L 155, 17.6.2017, p. 1.

32

(33)  
  OJ L 259, 7.10.2017, p. 11.

33

(34)  
  OJ L 276, 26.10.2017, p. 4.

34

(35)  
  OJ L 276, 26.10.2017, p. 32.

35

(36)  
  OJ L 304, 21.11.2017, p. 6.

36

(37)  
  OJ L 312, 28.11.2017, p. 1.

37

(38)  
  OJ L 343, 22.12.2017, p. 48.

38

(39)  
  OJ L 12, 17.1.2018, p. 2.

39

(40)  
  OJ L 137, 26.5.2016, p. 10.

40

(41)  
  OJ L 144, 7.6.2017, p. 12.

41

(42)  
  OJ L 148, 10.6.2017, p. 3.

42

(43)  
  OJ L 148, 10.6.2017, p. 16.

43

(44)  
  OJ L 149, 13.6.2017, p. 3.

44

(45)  
  OJ L 153, 16.6.2017, p. 1.

45

(46)  
  OJ L 158, 21.6.2017, p. 16.

46

(47)  
  OJ L 162, 23.6.2017, p. 3.

47

(48)  
  OJ L 162, 23.6.2017, p. 14.

48

(49)  
  OJ L 276, 26.10.2017, p. 12.

49

(50)  
  OJ L 276, 26.10.2017, p. 22.

50

(51)  
  OJ L 340, 20.12.2017, p. 6.

51

(52)  
  OJ L 87, 31.3.2017, p. 500.

52

(53)  
  OJ L 320, 6.12.2017, p. 11.

53

(54)  
  OJ L 331, 14.12.2017, p. 81.

54

(55)  
  OJ L 331, 14.12.2017, p. 87.

55

(56)  
  OJ L 331, 14.12.2017, p. 94.

56

(57)  
  OJ L 344, 23.12.2017, p. 52.

57

(58)  See page 142 of this Official Journal.

58

(*1)  No constitutional requirements indicated.

*1

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