# Official Journal L 109/2019

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 109 |
| | |
| English edition | Legislation | Volume 6224 April 2019 |

ISSN 1977-0677

Official Journal

of the European Union

L 109

English edition

Legislation

Volume 6224 April 2019

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2019/634 of 9 April 2019 on the signing, on behalf of the Union, of the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina | 1 |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2019/635 of 16 April 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Lechazo de Castilla y León (PGI)) | 4 |
| | * | Commission Regulation (EU) 2019/636 of 23 April 2019 amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants | 6 |
| | * | Commission Implementing Regulation (EU) 2019/637 of 23 April 2019 approving cholecalciferol as an active substance for use in biocidal products of product-type 14 (
  1
  ) | 13 |
| | | DECISIONS |
| | * | Council Decision (EU) 2019/638 of 15 April 2019 on the position to be taken on behalf of the European Union at the fourteenth meeting of the Conference of the Parties with regard to certain amendments to Annexes II, VIII and IX to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal | 19 |
| | * | Council Decision (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants | 22 |
| | * | Council Decision (EU) 2019/640 of 15 April 2019 concerning the allocation of funds decommitted from projects under the 10th European Development Fund for the purpose of replenishing the African Peace Facility | 24 |
| | * | Commission Implementing Decision (EU) 2019/641 of 17 April 2019 on the terms and conditions of the authorisation of a biocidal product family containing 1R-trans phenothrin referred by Ireland in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
  (notified under document C(2019) 2837)

   (
  1
  ) | 26 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2019/634 of 9 April 2019 on the signing, on behalf of the Union, of the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina

1

REGULATIONS

*

Commission Implementing Regulation (EU) 2019/635 of 16 April 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Lechazo de Castilla y León (PGI))

4

*

Commission Regulation (EU) 2019/636 of 23 April 2019 amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants

6

*

Commission Implementing Regulation (EU) 2019/637 of 23 April 2019 approving cholecalciferol as an active substance for use in biocidal products of product-type 14 (
  1
  )

1

13

DECISIONS

*

Council Decision (EU) 2019/638 of 15 April 2019 on the position to be taken on behalf of the European Union at the fourteenth meeting of the Conference of the Parties with regard to certain amendments to Annexes II, VIII and IX to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal

19

*

Council Decision (EU) 2019/639 of 15 April 2019 on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants

22

*

Council Decision (EU) 2019/640 of 15 April 2019 concerning the allocation of funds decommitted from projects under the 10th European Development Fund for the purpose of replenishing the African Peace Facility

24

*

Commission Implementing Decision (EU) 2019/641 of 17 April 2019 on the terms and conditions of the authorisation of a biocidal product family containing 1R-trans phenothrin referred by Ireland in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
  (notified under document C(2019) 2837)

   (
  1
  )

(notified under document C(2019) 2837)

1

26

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Implementing Regulation (EU) 2018/1506 of 10 October 2018 on exceptional market support measures for the eggs and poultrymeat sectors in Italy ( OJ L 255, 11.10.2018 ) | 28 |
| | * | Corrigendum to Commission Regulation (EU) 2019/50 of 11 January 2019 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorantraniliprole, clomazone, cyclaniliprole, fenazaquin, fenpicoxamid, fluoxastrobin, lambda-cyhalothrin, mepiquat, onion oil, thiacloprid and valifenalate in or on certain products ( OJ L 10, 14.1.2019 ) | 28 |
| | * | Corrigendum to Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 87/391/EEC) ( OJ L 156, 21.6.1990 ) | 29 |

Corrigenda

*

Corrigendum to Commission Implementing Regulation (EU) 2018/1506 of 10 October 2018 on exceptional market support measures for the eggs and poultrymeat sectors in Italy ( OJ L 255, 11.10.2018 )

( OJ L 255, 11.10.2018 )

28

*

Corrigendum to Commission Regulation (EU) 2019/50 of 11 January 2019 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorantraniliprole, clomazone, cyclaniliprole, fenazaquin, fenpicoxamid, fluoxastrobin, lambda-cyhalothrin, mepiquat, onion oil, thiacloprid and valifenalate in or on certain products ( OJ L 10, 14.1.2019 )

( OJ L 10, 14.1.2019 )

28

*

Corrigendum to Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 87/391/EEC) ( OJ L 156, 21.6.1990 )

( OJ L 156, 21.6.1990 )

29

| | |
| --- | --- |
| | (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

INTERNATIONAL AGREEMENTS

| 24.4.2019 | EN | Official Journal of the European Union | L 109/1 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/1

---

COUNCIL DECISION (EU) 2019/634

of 9 April 2019

on the signing, on behalf of the Union, of the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular points (b) and (d) of Article 77(2) and point (c) of Article 79(2), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Pursuant to Article 54(4) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (1), in cases where it is envisaged that European Border and Coast Guard teams are deployed to a third country to carry out actions for which the team members have executive powers, or where it is required by other actions in third countries, a status agreement is to be concluded by the Union with the third country concerned. That status agreement should cover all aspects that are necessary for carrying out the actions. |
| --- | --- |

(1)

Pursuant to Article 54(4) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (1), in cases where it is envisaged that European Border and Coast Guard teams are deployed to a third country to carry out actions for which the team members have executive powers, or where it is required by other actions in third countries, a status agreement is to be concluded by the Union with the third country concerned. That status agreement should cover all aspects that are necessary for carrying out the actions.

| (2) | On 16 October 2017, the Council authorised the Commission to open negotiations with Bosnia and Herzegovina for a status agreement on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina (‘the Agreement’). |
| --- | --- |

(2)

On 16 October 2017, the Council authorised the Commission to open negotiations with Bosnia and Herzegovina for a status agreement on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina (‘the Agreement’).

| (3) | The negotiations were successfully finalised by the initialling of the Agreement in January 2019. |
| --- | --- |

(3)

The negotiations were successfully finalised by the initialling of the Agreement in January 2019.

| (4) | This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (2); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
| --- | --- |

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (2); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

| (5) | This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (3); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
| --- | --- |

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (3); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

| (6) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law. |
| --- | --- |

(6)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law.

| (7) | Therefore, the Agreement should be signed and the annexed joint declaration should be approved, |
| --- | --- |

(7)

Therefore, the Agreement should be signed and the annexed joint declaration should be approved,

HAS ADOPTED THIS DECISION:

Article 1

The signing on behalf of the Union of the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina is hereby authorised, subject to the conclusion of the said Agreement (4).

Article 2

The joint declaration annexed to this Decision shall be approved on behalf of the Union.

Article 3

The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 4

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 9 April 2019.

For the Council

The President

G. CIAMBA

---

(1)  Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1).

1

(2)  Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43).

2

acquis

(3)  Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).

3

acquis

(4)  The text of the Agreement will be published together with the decision on its conclusion.

4

---

ANNEX

JOINT DECLARATION WITH REGARD TO ICELAND, NORWAY, SWITZERLAND AND LIECHTENSTEIN

The Parties to the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina take note of the close relationship between the European Union and Norway, Iceland, Switzerland and Liechtenstein, particularly by virtue of the Agreements of 18 May 1999 and 26 October 2004 concerning the association of those countries with the implementation, application and development of the Schengen acquis.

In such circumstances it is desirable that the authorities of Norway, Iceland, Switzerland and Liechtenstein, on the one hand, and Bosnia and Herzegovina, on the other hand, conclude, without delay, bilateral agreements on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina in terms similar to those of the Status Agreement between the European Union and Bosnia and Herzegovina on actions carried out by the European Border and Coast Guard Agency in Bosnia and Herzegovina.

---

REGULATIONS

| 24.4.2019 | EN | Official Journal of the European Union | L 109/4 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/4

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/635

of 16 April 2019

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Lechazo de Castilla y León’ (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) | By virtue of the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Lechazo de Castilla y León’, registered under Commission Regulation (EC) No 2107/1999 (2). |
| --- | --- |

(1)

By virtue of the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Lechazo de Castilla y León’, registered under Commission Regulation (EC) No 2107/1999 (2).

| (2) | Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation. |
| --- | --- |

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

| (3) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved, |
| --- | --- |

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Lechazo de Castilla y León’ (PGI) are hereby approved.

Article 2

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

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

Done at Brussels, 16 April 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)  Commission Regulation (EC) No 2107/1999 of 4 October 1999 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 258, 5.10.1999, p. 3).

2

(3)  
  OJ C 432, 30.11.2018, p. 3.

3

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/6 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/6

---

COMMISSION REGULATION (EU) 2019/636

of 23 April 2019

amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (1), and in particular Article 7(4)(a) and (5) and Article 14(2) and (4) thereof,

Whereas:

| (1) | Regulation (EC) No 850/2004 implements in the law of the Union the commitments set out in the Stockholm Convention on Persistent Organic Pollutants (hereinafter ‘the Convention’) approved on behalf of the Community by Council Decision 2006/507/EC (2), and in the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants approved on behalf of the Community by Council Decision 2004/259/EC (3). |
| --- | --- |

(1)

Regulation (EC) No 850/2004 implements in the law of the Union the commitments set out in the Stockholm Convention on Persistent Organic Pollutants (hereinafter ‘the Convention’) approved on behalf of the Community by Council Decision 2006/507/EC (2), and in the Protocol to the 1979 Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants approved on behalf of the Community by Council Decision 2004/259/EC (3).

| (2) | At the seventh meeting of the Conference of the Parties to the Convention from 4 to 15 May 2015, it was agreed to include pentachlorophenol and its salts and esters (hereinafter ‘pentachlorophenol’) in Annex A (elimination) to the Convention. |
| --- | --- |

(2)

At the seventh meeting of the Conference of the Parties to the Convention from 4 to 15 May 2015, it was agreed to include pentachlorophenol and its salts and esters (hereinafter ‘pentachlorophenol’) in Annex A (elimination) to the Convention.

| (3) | In view of the amendment of the Convention, it is necessary to amend Annexes IV and V to Regulation (EC) No 850/2004, including pentachlorophenol in the annexes and indicating the corresponding concentration limits, in order to ensure that wastes containing pentachlorophenol are managed in accordance with the provisions of the Convention. |
| --- | --- |

(3)

In view of the amendment of the Convention, it is necessary to amend Annexes IV and V to Regulation (EC) No 850/2004, including pentachlorophenol in the annexes and indicating the corresponding concentration limits, in order to ensure that wastes containing pentachlorophenol are managed in accordance with the provisions of the Convention.

| (4) | The proposed concentration limits in Annexes IV and V to Regulation (EC) No 850/2004 have been set applying the same methodology that was used for establishing the limit values in previous amendments of Annexes IV and V (4). The proposed concentration limits are considered the most appropriate to ensure a high level of protection of human health and the environment in view of the destruction or irreversible transformation of pentachlorophenol. |
| --- | --- |

(4)

The proposed concentration limits in Annexes IV and V to Regulation (EC) No 850/2004 have been set applying the same methodology that was used for establishing the limit values in previous amendments of Annexes IV and V (4). The proposed concentration limits are considered the most appropriate to ensure a high level of protection of human health and the environment in view of the destruction or irreversible transformation of pentachlorophenol.

| (5) | It is appropriate to provide for a sufficient period of time to allow companies and competent authorities to adapt to the new requirements. |
| --- | --- |

(5)

It is appropriate to provide for a sufficient period of time to allow companies and competent authorities to adapt to the new requirements.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 39 of Directive 2008/98/EC of the European Parliament and of the Council (5), |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 39 of Directive 2008/98/EC of the European Parliament and of the Council (5),

HAS ADOPTED THIS REGULATION:

Article 1

Annexes IV and V to Regulation (EC) No 850/2004 are amended in accordance with the Annex to this Regulation.

Article 2

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

It shall apply from 31 October 2019.

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

Done at Brussels, 23 April 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 158, 30.4.2004, p. 7.

1

(2)  Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1).

2

(3)  Council Decision 2004/259/EC of 19 February 2004 concerning the conclusion, on behalf of the European Community, of the Protocol to the 1979 Convention on Long Range Transboundary Air Pollution on Persistent Organic Pollutants (OJ L 81, 19.3.2004, p. 35).

3

(4)  Council Regulation (EC) No 1195/2006 of 18 July 2006 amending Annex IV to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants (OJ L 217, 8.8.2006, p. 1), Council Regulation (EC) No 172/2007 of 16 February 2007 amending Annex V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants (OJ L 55, 23.2.2007, p. 1), Commission Regulation (EU) No 756/2010 of 24 August 2010 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annexes IV and V (OJ L 223, 25.8.2010, p. 20), Commission Regulation (EU) No 1342/2014 of 17 December 2014 amending Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants as regards Annexes IV and V (OJ L 363, 18.12.2014, p. 67) and Commission Regulation (EU) 2016/460 of 30 March 2016 amending Annexes IV and V to Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants (OJ L 80, 31.3.2016, p. 17).

4

(5)  Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

5

---

ANNEX

Annexes IV and V to Regulation (EC) No 850/2004 are amended as follows:

| (1) | in the table of Annex IV, the following row is added:

  List of substances subject to waste management provisions set out in Article 7










  Substance | CAS No | EC No | Concentration limit referred to in Article 7(4)(a) |
| --- | --- | --- | --- | --- |
| ‘Pentachlorophenol and its salts and esters | 87-86-5 and others | 201-778-6 and others | 100 mg/kg’ |

(1)

in the table of Annex IV, the following row is added:

List of substances subject to waste management provisions set out in Article 7

Substance

CAS No

EC No

Concentration limit referred to in Article 7(4)(a)

‘Pentachlorophenol and its salts and esters

87-86-5 and others

201-778-6 and others

100 mg/kg’

| (2) | in Part 2 of Annex V, the table is replaced by the following table:








  ‘Wastes as classified in Commission Decision 2000/532/EC (1) | Maximum concentration limits of substances listed in Annex IV (2) | Operation |
| --- | --- | --- | --- |
| 10 | WASTES FROM THERMAL PROCESSES | Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs): 10 000 mg/kg;
  Aldrin: 5 000 mg/kg;
  Chlordane: 5 000 mg/kg;
  Chlordecone: 5 000 mg/kg;
  DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane): 5 000 mg/kg;
  Dieldrin: 5 000 mg/kg;
  Endosulfan: 5 000 mg/kg;
  Endrin: 5 000 mg/kg;
  Heptachlor: 5 000 mg/kg;
  Hexabromobiphenyl: 5 000 mg/kg;
  Hexabromocyclododecane (3): 1 000 mg/kg;
  Hexachlorobenzene: 5 000 mg/kg;
  Hexachlorobutadiene: 1 000 mg/kg;
  Hexachlorocyclohexanes, including lindane: 5 000 mg/kg;
  Mirex: 5 000 mg/kg;
  Pentachlorobenzene: 5 000 mg/kg;
  Pentachlorophenol and its salts and esters: 1 000 mg/kg;
  Perfluorooctane sulfonic acid and its derivatives (PFOS)
  (C8F17SO2X)
  (X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers): 50 mg/kg;
  Polychlorinated Biphenyls (PCB) (4): 50 mg/kg;
  Polychlorinated dibenzo-p-dioxins and dibenzofurans: 5 mg/kg;
  Polychlorinated naphthalenes (*1): 1 000 mg/kg;
  Sum of the concentrations of tetrabromodiphenyl ether C12H6Br4O), pentabromodiphenyl ether (C12H5Br5O), hexabromodiphenyl ether (C12H4Br6O) and heptabromodiphenyl ether (C12H3Br7O): 10 000  mg/kg;
  Toxaphene: 5 000 mg/kg. | Permanent storage shall be allowed only when all the following conditions are met:






  (1) | The storage takes place in one of the following locations:






  — | safe, deep, under-ground, hard rock formations; |

(2)

in Part 2 of Annex V, the table is replaced by the following table:

‘Wastes as classified in Commission Decision 2000/532/EC (1)

1

Maximum concentration limits of substances listed in Annex IV (2)

2

Operation

10

WASTES FROM THERMAL PROCESSES

Alkanes C10-C13, chloro (short-chain chlorinated paraffins) (SCCPs): 10 000 mg/kg;

Aldrin: 5 000 mg/kg;

Chlordane: 5 000 mg/kg;

Chlordecone: 5 000 mg/kg;

DDT (1,1,1-trichloro-2,2-bis (4-chlorophenyl) ethane): 5 000 mg/kg;

Dieldrin: 5 000 mg/kg;

Endosulfan: 5 000 mg/kg;

Endrin: 5 000 mg/kg;

Heptachlor: 5 000 mg/kg;

Hexabromobiphenyl: 5 000 mg/kg;

Hexabromocyclododecane (3): 1 000 mg/kg;

3

Hexachlorobenzene: 5 000 mg/kg;

Hexachlorobutadiene: 1 000 mg/kg;

Hexachlorocyclohexanes, including lindane: 5 000 mg/kg;

Mirex: 5 000 mg/kg;

Pentachlorobenzene: 5 000 mg/kg;

Pentachlorophenol and its salts and esters: 1 000 mg/kg;

Perfluorooctane sulfonic acid and its derivatives (PFOS)

(C8F17SO2X)

8

17

2

(X = OH, Metal salt (O-M+), halide, amide, and other derivatives including polymers): 50 mg/kg;

+

Polychlorinated Biphenyls (PCB) (4): 50 mg/kg;

4

Polychlorinated dibenzo-p-dioxins and dibenzofurans: 5 mg/kg;

Polychlorinated naphthalenes (*1): 1 000 mg/kg;

*1

Sum of the concentrations of tetrabromodiphenyl ether C12H6Br4O), pentabromodiphenyl ether (C12H5Br5O), hexabromodiphenyl ether (C12H4Br6O) and heptabromodiphenyl ether (C12H3Br7O): 10 000  mg/kg;

12

6

4

12

5

5

12

4

6

12

3

7

Toxaphene: 5 000 mg/kg.

Permanent storage shall be allowed only when all the following conditions are met:

(1)

The storage takes place in one of the following locations:

—

safe, deep, under-ground, hard rock formations;

| — | salt mines; |
| --- | --- |

—

salt mines;

| — | a landfill site for hazardous waste, provided that the waste is solidified or partly stabilised where technically feasible as required for classification of the waste in subchapter 19 03 of Decision 2000/532/EC. |
| --- | --- |

—

a landfill site for hazardous waste, provided that the waste is solidified or partly stabilised where technically feasible as required for classification of the waste in subchapter 19 03 of Decision 2000/532/EC.

| (2) | The provisions of Council Directive 1999/31/EC (5) and Council Decision 2003/33/EC (6) were respected. |
| --- | --- |

(2)

The provisions of Council Directive 1999/31/EC (5) and Council Decision 2003/33/EC (6) were respected.

5

6

| (3) | It has been demonstrated that the selected operation is environmentally preferable. |
| --- | --- |

(3)

It has been demonstrated that the selected operation is environmentally preferable.

10 01

Wastes from power stations and other combustion plants (except 19)

10 01 14 (*1)

*1

Bottom ash, slag and boiler dust from co-incineration containing hazardous substances

10 01 16 (*1)

*1

Fly ash from co-incineration containing hazardous substances

10 02

Wastes from the iron and steel industry

10 02 07 (*1)

*1

Solid wastes from gas treatment containing hazardous substances

10 03

Wastes from aluminium thermal metallurgy

10 03 04 (*1)

*1

Primary production slags

10 03 08 (*1)

*1

Salt slags from secondary production

10 03 09 (*1)

*1

Black drosses from secondary production

10 03 19 (*1)

*1

Flue-gas dust containing hazardous substances

10 03 21 (*1)

*1

Other particulates and dust (including ball-mill dust) containing hazardous substances

10 03 29 (*1)

*1

Wastes from treatment of salt slags and black drosses containing hazardous substances

10 04

Wastes from lead thermal metallurgy

10 04 01 (*1)

*1

Slags from primary and secondary production

10 04 02 (*1)

*1

Dross and skimmings from primary and secondary production

10 04 04 (*1)

*1

Flue-gas dust

10 04 05 (*1)

*1

Other particulates and dust

10 04 06 (*1)

*1

Solid wastes from gas treatment

10 05

Wastes from zinc thermal metallurgy

10 05 03 (*1)

*1

Flue-gas dust

10 05 05 (*1)

*1

Solid waste from gas treatment

10 06

Wastes from copper thermal metallurgy

10 06 03 (*1)

*1

Flue-gas dust

10 06 06 (*1)

*1

Solid wastes from gas treatment

10 08

Wastes from other non-ferrous thermal metallurgy

10 08 08 (*1)

*1

Salt slag from primary and secondary production

10 08 15 (*1)

*1

Flue-gas dust containing hazardous substances

10 09

Wastes from casting of ferrous pieces

10 09 09 (*1)

*1

Flue-gas dust containing hazardous substances

16

WASTES NOT OTHERWISE SPECIFIED IN THE LIST

16 11

Waste linings and refractories

16 11 01 (*1)

*1

Carbon-based linings and refractories from metallurgical processes containing hazardous substances

16 11 03 (*1)

*1

Other linings and refractories from metallurgical processes containing hazardous substances

17

CONSTRUCTION AND DEMOLITION WASTES (INCLUDING EXCAVATED SOIL FROM CONTAMINATED SITES)

17 01

Concrete, bricks, tiles and ceramics

17 01 06 (*1)

*1

Mixtures of, or separate fractions of concrete, bricks, tiles and ceramics containing hazardous substances

17 05

Soil (including excavated soil from contaminated sites), stones and dredging spoil

17 05 03 (*1)

*1

Soil and stones containing hazardous substances

17 09

Other construction and demolition wastes

17 09 02 (*1)

*1

Construction and demolition wastes containing PCB, excluding PCB containing equipment

17 09 03 (*1)

*1

Other construction and demolition wastes (including mixed wastes) containing hazardous substances

19

WASTES FROM WASTE MANAGEMENT FACILITIES, OFF-SITE WASTE WATER TREATMENT PLANTS AND THE PREPARATION OF WATER INTENDED FOR HUMAN CONSUMPTION AND WATER FROM INDUSTRIAL USE

19 01

Wastes from incineration or pyrolysis of waste

19 01 07 (*1)

*1

Solid wastes from gas treatment

19 01 11 (*1)

*1

Bottom ash and slag containing hazardous substances

19 01 13 (*1)

*1

Fly ash containing hazardous substances

19 01 15 (*1)

*1

Boiler dust containing hazardous substances

19 04

Vitrified waste and waste from vitrification

19 04 02 (*1)

*1

Fly ash and other flue-gas treatment wastes

19 04 03 (*1)

*1

Non-vitrified solid phase’

The maximum concentration limit of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD and PCDF) shall be calculated according to the following toxic equivalency factors (TEFs):

| PCDD | TEF |
| --- | --- |
| 2,3,7,8-TeCDD | 1 |
| 1,2,3,7,8-PeCDD | 1 |
| 1,2,3,4,7,8-HxCDD | 0,1 |
| 1,2,3,6,7,8-HxCDD | 0,1 |
| 1,2,3,7,8,9-HxCDD | 0,1 |
| 1,2,3,4,6,7,8-HpCDD | 0,01 |
| OCDD | 0,0003 |
| PCDF | TEF |
| 2,3,7,8-TeCDF | 0,1 |
| 1,2,3,7,8-PeCDF | 0,03 |
| 2,3,4,7,8-PeCDF | 0,3 |
| 1,2,3,4,7,8-HxCDF | 0,1 |
| 1,2,3,6,7,8-HxCDF | 0,1 |
| 1,2,3,7,8,9-HxCDF | 0,1 |
| 2,3,4,6,7,8-HxCDF | 0,1 |
| 1,2,3,4,6,7,8-HpCDF | 0,01 |
| 1,2,3,4,7,8,9-HpCDF | 0,01 |
| OCDF | 0,0003 |

PCDD

TEF

2,3,7,8-TeCDD

1

1,2,3,7,8-PeCDD

1

1,2,3,4,7,8-HxCDD

0,1

1,2,3,6,7,8-HxCDD

0,1

1,2,3,7,8,9-HxCDD

0,1

1,2,3,4,6,7,8-HpCDD

0,01

OCDD

0,0003

PCDF

TEF

2,3,7,8-TeCDF

0,1

1,2,3,7,8-PeCDF

0,03

2,3,4,7,8-PeCDF

0,3

1,2,3,4,7,8-HxCDF

0,1

1,2,3,6,7,8-HxCDF

0,1

1,2,3,7,8,9-HxCDF

0,1

2,3,4,6,7,8-HxCDF

0,1

1,2,3,4,6,7,8-HpCDF

0,01

1,2,3,4,7,8,9-HpCDF

0,01

OCDF

0,0003

---

(1)  2000/532/EC: Commission Decision of 3 May 2000 replacing Decision 94/3/EC establishing a list of wastes pursuant to Article 1(a) of Council Directive 75/442/EEC on waste and Council Decision 94/904/EC establishing a list of hazardous waste pursuant to Article 1(4) of Council Directive 91/689/EEC on hazardous waste (OJ L 226, 6.9.2000, p. 3).

1

(2)  These limits apply exclusively to a landfill site for hazardous waste and do not apply to permanent underground storage facilities for hazardous waste, including salt mines.

2

(3)  
  ‘Hexabromocyclododecane’ means hexabromocyclododecane, 1,2,5,6,9,10-hexabromocyclododecane and its main diastereoisomers: alpha- hexabromocyclododecane, beta- hexabromocyclododecane and gamma- hexabromocyclododecane.

3

(4)  The calculation method laid down in European standards EN 12766-1 and EN 12766-2 shall apply.

4

(5)  Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste (OJ L 182, 16.7.1999, p. 1).

5

(6)  Council Decision 2003/33/EC of 19 December 2002 establishing criteria and procedures for the acceptance of waste at landfills pursuant to Article 16 of and Annex II to Directive 1999/31/EC (OJ L 11, 16.1.2003, p. 27).

6

(*1)  Any waste marked with an asterisk ‘*’ is considered as hazardous waste pursuant to Directive 2008/98/EC and is subject to the provisions of that Directive.

*1

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/13 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/13

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/637

of 23 April 2019

approving cholecalciferol as an active substance for use in biocidal products of product-type 14

(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 9(1)(a) thereof,

Whereas:

| (1) | The evaluating competent authority of Sweden received on 19 April 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance cholecalciferol in Annex I to that Directive for use in biocidal products of product-type 14, rodenticides, as described in Annex V to Directive 98/8/EC, which corresponds to product-type 14 as described in Annex V to Regulation (EU) No 528/2012. |
| --- | --- |

(1)

The evaluating competent authority of Sweden received on 19 April 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance cholecalciferol in Annex I to that Directive for use in biocidal products of product-type 14, rodenticides, as described in Annex V to Directive 98/8/EC, which corresponds to product-type 14 as described in Annex V to Regulation (EU) No 528/2012.

| (2) | On 15 April 2016, the evaluating competent authority of Sweden submitted, in accordance with Article 8(1) of Regulation (EU) No 528/2012, the assessment report together with its recommendations to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(2)

On 15 April 2016, the evaluating competent authority of Sweden submitted, in accordance with Article 8(1) of Regulation (EU) No 528/2012, the assessment report together with its recommendations to the European Chemicals Agency (‘the Agency’).

| (3) | The opinion of the Agency (3) was adopted on 13 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority. |
| --- | --- |

(3)

The opinion of the Agency (3) was adopted on 13 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

| (4) | According to that opinion, cholecalciferol is a pro-hormone and therefore meets the criteria laid down in Commission Delegated Regulation (EU) 2017/2100 (4) to be considered as having endocrine-disrupting properties that may cause adverse effects in humans. Cholecalciferol therefore meets the exclusion criterion set in Article 5(1)(d) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

According to that opinion, cholecalciferol is a pro-hormone and therefore meets the criteria laid down in Commission Delegated Regulation (EU) 2017/2100 (4) to be considered as having endocrine-disrupting properties that may cause adverse effects in humans. Cholecalciferol therefore meets the exclusion criterion set in Article 5(1)(d) of Regulation (EU) No 528/2012.

| (5) | In addition, according to that opinion, the use of products containing cholecalciferol raises concerns of primary and secondary poisoning, even when restrictive risk management measures are applied and therefore cholecalciferol also satisfies the criterion to be considered a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012. |
| --- | --- |

(5)

In addition, according to that opinion, the use of products containing cholecalciferol raises concerns of primary and secondary poisoning, even when restrictive risk management measures are applied and therefore cholecalciferol also satisfies the criterion to be considered a candidate for substitution in accordance with Article 10(1)(e) of Regulation (EU) No 528/2012.

| (6) | Pursuant to Article 5(2) of Regulation (EU) No 528/2012, an active substance meeting an exclusion criterion may only be approved if it is shown that at least one of the conditions for derogation set out in that Article is met. |
| --- | --- |

(6)

Pursuant to Article 5(2) of Regulation (EU) No 528/2012, an active substance meeting an exclusion criterion may only be approved if it is shown that at least one of the conditions for derogation set out in that Article is met.

| (7) | In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation between 17 July 2017 and 15 September 2017 in order to collect relevant information, including information on available substitutes (5). |
| --- | --- |

(7)

In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation between 17 July 2017 and 15 September 2017 in order to collect relevant information, including information on available substitutes (5).

| (8) | The Commission also carried out a specific public consultation between 7 February 2018 and 7 April 2018 in order to gather information as to whether the conditions for derogation set out in Article 5(2) of Regulation (EU) No 528/2012 were satisfied. The Commission made the contributions received during that consultation publicly available (6). |
| --- | --- |

(8)

The Commission also carried out a specific public consultation between 7 February 2018 and 7 April 2018 in order to gather information as to whether the conditions for derogation set out in Article 5(2) of Regulation (EU) No 528/2012 were satisfied. The Commission made the contributions received during that consultation publicly available (6).

| (9) | The information obtained as a result of the two above-mentioned public consultations, the experience gained in authorising rodenticide products and the renewal of approval of anticoagulant active substances used in rodenticides, and the information on the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission final report on risk mitigation measures for anticoagulant rodenticides as biocidal products (7), were discussed with Member States in the Standing Committee on Biocidal Products. |
| --- | --- |

(9)

The information obtained as a result of the two above-mentioned public consultations, the experience gained in authorising rodenticide products and the renewal of approval of anticoagulant active substances used in rodenticides, and the information on the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission final report on risk mitigation measures for anticoagulant rodenticides as biocidal products (7), were discussed with Member States in the Standing Committee on Biocidal Products.

| (10) | Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health. Anticoagulant active substances, which are the main active substances used in rodenticides for now, also meet the exclusion criteria laid down in Article 5(1) of Regulation (EU) No 528/2012 as they are classified as toxic for reproduction category 1B and most of them are persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) substances. Other alternative active substances currently approved for product-type 14 and not subject to exclusion, namely carbon dioxide, alphachloralose, aluminium phosphide, hydrogen cyanide and powdered corn cob, have constraints inherent in their nature and restricted conditions of use. Non-chemical control or prevention methods for rodents, such as mechanical, electrical or glue traps, may not be sufficiently efficient and may raise further questions as to whether they are humane and whether they cause unnecessary suffering to rodents. |
| --- | --- |

(10)

Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health. Anticoagulant active substances, which are the main active substances used in rodenticides for now, also meet the exclusion criteria laid down in Article 5(1) of Regulation (EU) No 528/2012 as they are classified as toxic for reproduction category 1B and most of them are persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) substances. Other alternative active substances currently approved for product-type 14 and not subject to exclusion, namely carbon dioxide, alphachloralose, aluminium phosphide, hydrogen cyanide and powdered corn cob, have constraints inherent in their nature and restricted conditions of use. Non-chemical control or prevention methods for rodents, such as mechanical, electrical or glue traps, may not be sufficiently efficient and may raise further questions as to whether they are humane and whether they cause unnecessary suffering to rodents.

| (11) | The approval of cholecalciferol would bring an additional active substance on the market and would be useful to manage the increasing development of resistance of rodents to anticoagulant active substances, as cholecalciferol acts in a completely different way compared to the anticoagulants. The availability of cholecalciferol may also reduce the use of anticoagulant active substances and in particular of the most potent second-generation thereof. Thus, cholecalciferol can play a role in the future to ensure satisfactory control of rodent populations within an integrated pest management approach, in support of the above-mentioned alternatives not subject to the exclusion criteria, and possibly reducing the recourse to anticoagulant active substances in rodenticides. |
| --- | --- |

(11)

The approval of cholecalciferol would bring an additional active substance on the market and would be useful to manage the increasing development of resistance of rodents to anticoagulant active substances, as cholecalciferol acts in a completely different way compared to the anticoagulants. The availability of cholecalciferol may also reduce the use of anticoagulant active substances and in particular of the most potent second-generation thereof. Thus, cholecalciferol can play a role in the future to ensure satisfactory control of rodent populations within an integrated pest management approach, in support of the above-mentioned alternatives not subject to the exclusion criteria, and possibly reducing the recourse to anticoagulant active substances in rodenticides.

| (12) | Furthermore, insufficient rodent control may cause not only significant negative impacts on human or animal health or the environment, but also affect the public's perception of its safety with regard to exposure to rodents or the security of a number of economic activities that could be vulnerable to rodents, entailing economic and social consequences. Despite its endocrine disrupting properties, cholecalciferol may be considered to have overall better toxicological and ecotoxicological profiles compared to anticoagulant active substances as it is neither classified as toxic for reproduction category 1B, nor a PBT or vPvB. Cholecalciferol is Vitamin D3, which — at the right dose — is an essential element for human life, and is expected to present lower risks to humans compared to anticoagulant active substances when used as a rodenticide. The risks to human health, animal health or the environment arising from use of products containing cholecalciferol can be mitigated if certain specifications and conditions are respected. As already explained, cholecalciferol can play a role in the future to contribute to a satisfactory control of rodent populations within an integrated pest management approach, in support of the above-mentioned alternatives not subject to the exclusion criteria, and possibly reducing the recourse to anticoagulant rodenticides which present higher overall concerns. In this context, not approving that active substance would deprive users of a tool for rodent control which could bring added value and which is at least as suitable as many other alternative substances used. Therefore, the non-approval of cholecalciferol as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance. The condition set out in Article 5(2)(c) is thus satisfied. |
| --- | --- |

(12)

Furthermore, insufficient rodent control may cause not only significant negative impacts on human or animal health or the environment, but also affect the public's perception of its safety with regard to exposure to rodents or the security of a number of economic activities that could be vulnerable to rodents, entailing economic and social consequences. Despite its endocrine disrupting properties, cholecalciferol may be considered to have overall better toxicological and ecotoxicological profiles compared to anticoagulant active substances as it is neither classified as toxic for reproduction category 1B, nor a PBT or vPvB. Cholecalciferol is Vitamin D3, which — at the right dose — is an essential element for human life, and is expected to present lower risks to humans compared to anticoagulant active substances when used as a rodenticide. The risks to human health, animal health or the environment arising from use of products containing cholecalciferol can be mitigated if certain specifications and conditions are respected. As already explained, cholecalciferol can play a role in the future to contribute to a satisfactory control of rodent populations within an integrated pest management approach, in support of the above-mentioned alternatives not subject to the exclusion criteria, and possibly reducing the recourse to anticoagulant rodenticides which present higher overall concerns. In this context, not approving that active substance would deprive users of a tool for rodent control which could bring added value and which is at least as suitable as many other alternative substances used. Therefore, the non-approval of cholecalciferol as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance. The condition set out in Article 5(2)(c) is thus satisfied.

| (13) | It is therefore appropriate to approve cholecalciferol for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions. |
| --- | --- |

(13)

It is therefore appropriate to approve cholecalciferol for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.

| (14) | As cholecalciferol meets exclusion criterion laid down in Article 5(1)(d) of Regulation (EU) No 528/2012, the approval should be for a period not exceeding five years as set out in the second sentence of Article 4(1) of that Regulation. |
| --- | --- |

(14)

As cholecalciferol meets exclusion criterion laid down in Article 5(1)(d) of Regulation (EU) No 528/2012, the approval should be for a period not exceeding five years as set out in the second sentence of Article 4(1) of that Regulation.

| (15) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Cholecalciferol is approved as an active substance for use in biocidal products of product-type 14, subject to the specifications and conditions set out in the Annex.

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, 23 April 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

2

(3)  Biocidal Products Committee Opinion on the application for approval of the active substance: Cholecalciferol, Product type: 14, ECHA/BPC/180/2017.

3

(4)  Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

4

(5)  https://echa.europa.eu/potential-candidates-for-substitution-previous-consultations

5

(6)  https://circabc.europa.eu/w/browse/c29a57c2-e31d-43d8-9675-6aec345218cf

6

(7)  https://circabc.europa.eu/sd/a/352bffd8-babc-4af8-9d0c-a1c87a3c3afc/Final%20Report%20RMM.pdf

7

---

ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions |
| --- | --- | --- | --- | --- | --- | --- |
| Cholecalciferol | IUPAC Name:
  (3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol
  EC No: 200-673-2
  CAS No: 67-97-0 | 970 g/kg | 1 July 2019 | 30 June 2024 | 14 | Cholecalciferol is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.
  The authorisations of biocidal products are subject to the following general conditions:






  (1) | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions

Cholecalciferol

IUPAC Name:

(3β,5Z,7E)-9,10-secocholesta-5,7,10(19)-trien-3-ol

EC No: 200-673-2

CAS No: 67-97-0

970 g/kg

1 July 2019

30 June 2024

14

Cholecalciferol is considered a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012.

The authorisations of biocidal products are subject to the following general conditions:

(1)

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

| (2) | Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied. |
| --- | --- |

(2)

Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied.

| (3) | According to point (d) of Article 19(4) of Regulation (EU) No 528/2012, products shall not be authorised for making available on the market for use by the general public. |
| --- | --- |

(3)

According to point (d) of Article 19(4) of Regulation (EU) No 528/2012, products shall not be authorised for making available on the market for use by the general public.

| (4) | The nominal concentration of cholecalciferol in the products shall not exceed 0,075 % w/w. |
| --- | --- |

(4)

The nominal concentration of cholecalciferol in the products shall not exceed 0,075 % w/w.

| (5) | Products shall contain an aversive agent and a dye. |
| --- | --- |

(5)

Products shall contain an aversive agent and a dye.

| (6) | Products shall not be authorised in the form of tracking powder. |
| --- | --- |

(6)

Products shall not be authorised in the form of tracking powder.

| (7) | Products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals. |
| --- | --- |

(7)

Products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals.

| (8) | Only ready-to-use products shall be authorised. |
| --- | --- |

(8)

Only ready-to-use products shall be authorised.

| (9) | Primary as well as secondary exposure of humans, non-target animals and the environment shall be minimised, by considering and applying all appropriate and available risk mitigation measures. They include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category. |
| --- | --- |

(9)

Primary as well as secondary exposure of humans, non-target animals and the environment shall be minimised, by considering and applying all appropriate and available risk mitigation measures. They include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.

| (10) | Dead bodies and uneaten bait shall be disposed of in accordance with local requirements. The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label. |
| --- | --- |

(10)

Dead bodies and uneaten bait shall be disposed of in accordance with local requirements. The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label.

In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:

| (1) | Products may be authorised for use in sewers, open area or waste dumps. |
| --- | --- |

(1)

Products may be authorised for use in sewers, open area or waste dumps.

| (2) | Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations. |
| --- | --- |

(2)

Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations.

| (3) | Products may only be authorised for use in permanent treatments at sites with a high potential for reinvasion when other methods of control have proven insufficient. |
| --- | --- |

(3)

Products may only be authorised for use in permanent treatments at sites with a high potential for reinvasion when other methods of control have proven insufficient.

| (4) | Products shall not be authorised for use in pulse baiting treatments. |
| --- | --- |

(4)

Products shall not be authorised for use in pulse baiting treatments.

| (5) | Persons making available on the market products for trained professional users shall make sure that those products are not supplied to other persons than trained professionals. |
| --- | --- |

(5)

Persons making available on the market products for trained professional users shall make sure that those products are not supplied to other persons than trained professionals.

In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:

| (1) | Products shall not be authorised for use in sewers, open area or waste dumps. |
| --- | --- |

(1)

Products shall not be authorised for use in sewers, open area or waste dumps.

| (2) | Products shall not be authorised for use as a permanent bait or pulse baiting treatments. |
| --- | --- |

(2)

Products shall not be authorised for use as a permanent bait or pulse baiting treatments.

| (3) | Products shall only be authorised for use in tamper-resistant bait stations. |
| --- | --- |

(3)

Products shall only be authorised for use in tamper-resistant bait stations.

| (4) | Persons making available on the market products for professional users shall make sure that those products are not supplied to the general public. |
| --- | --- |

(4)

Persons making available on the market products for professional users shall make sure that those products are not supplied to the general public.

---

(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

---

DECISIONS

| 24.4.2019 | EN | Official Journal of the European Union | L 109/19 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/19

---

COUNCIL DECISION (EU) 2019/638

of 15 April 2019

on the position to be taken on behalf of the European Union at the fourteenth meeting of the Conference of the Parties with regard to certain amendments to Annexes II, VIII and IX to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (the ‘Convention’) entered into force in 1992 and was concluded by the Union by means of Council Decision 93/98/EEC (1). |
| --- | --- |

(1)

The Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (the ‘Convention’) entered into force in 1992 and was concluded by the Union by means of Council Decision 93/98/EEC (1).

| (2) | Regulation (EC) No 1013/2006 of the European Parliament and of the Council (2) implements the Convention and Organisation for Economic Cooperation and Development (OECD) Council Decision C(2001)107/FINAL concerning the revision of Decision C(92)39/FINAL on the control of transboundary movements of wastes destined for recovery operations (the ‘OECD Decision’) within the Union. |
| --- | --- |

(2)

Regulation (EC) No 1013/2006 of the European Parliament and of the Council (2) implements the Convention and Organisation for Economic Cooperation and Development (OECD) Council Decision C(2001)107/FINAL concerning the revision of Decision C(92)39/FINAL on the control of transboundary movements of wastes destined for recovery operations (the ‘OECD Decision’) within the Union.

| (3) | In accordance with the Convention, the Conference of the Parties shall consider and adopt, as required, amendments to the Convention. Amendments to the Convention are to be adopted at a meeting of the Conference of the Parties. |
| --- | --- |

(3)

In accordance with the Convention, the Conference of the Parties shall consider and adopt, as required, amendments to the Convention. Amendments to the Convention are to be adopted at a meeting of the Conference of the Parties.

| (4) | At its fourteenth meeting, the Conference of the Parties is expected to consider and adopt, as required, amendments to the Annexes to the Convention. Those amendments would add entries to Annexes II and VIII to the Convention and revise entry B3010 in Annex IX to the Convention. |
| --- | --- |

(4)

At its fourteenth meeting, the Conference of the Parties is expected to consider and adopt, as required, amendments to the Annexes to the Convention. Those amendments would add entries to Annexes II and VIII to the Convention and revise entry B3010 in Annex IX to the Convention.

| (5) | Proposals to amend Annexes II, VIII and IX to the Convention, submitted by Norway, were distributed to the Parties on 26 October 2018. A correction of the proposal to amend Annex IX was distributed to the Parties on 6 December 2018. Under the proposals, plastic waste requiring special consideration and hazardous plastic waste, as set out in new entries in Annexes II and VIII to the Convention, would fall under the Convention's control system, while non-hazardous plastic waste falling within a revised entry B3010 in Annex IX to the Convention would continue to be traded between countries subject to the current conditions under the Convention. |
| --- | --- |

(5)

Proposals to amend Annexes II, VIII and IX to the Convention, submitted by Norway, were distributed to the Parties on 26 October 2018. A correction of the proposal to amend Annex IX was distributed to the Parties on 6 December 2018. Under the proposals, plastic waste requiring special consideration and hazardous plastic waste, as set out in new entries in Annexes II and VIII to the Convention, would fall under the Convention's control system, while non-hazardous plastic waste falling within a revised entry B3010 in Annex IX to the Convention would continue to be traded between countries subject to the current conditions under the Convention.

| (6) | The Union should support the objectives of the proposed amendments to the Annexes to the Convention since they will contribute to: improving controls on plastic waste exports; preventing exports of plastic waste to countries lacking adequate infrastructures for effective collection and environmentally sound management of waste; supporting the environmentally sound management of plastic waste; reducing the risk of plastic waste finding its way into the environment; and preventing the global environmental problem of marine litter. The Union should, however, propose and support changes to the proposed amendments to the Annexes to the Convention proposed by Norway, with a view to clarifying the scope of those amendments and improving the text, as well as to setting an appropriate later date for application of those amendments than foreseen in Article 18 of the Convention, and thereby facilitating their implementation and enforcement. |
| --- | --- |

(6)

The Union should support the objectives of the proposed amendments to the Annexes to the Convention since they will contribute to: improving controls on plastic waste exports; preventing exports of plastic waste to countries lacking adequate infrastructures for effective collection and environmentally sound management of waste; supporting the environmentally sound management of plastic waste; reducing the risk of plastic waste finding its way into the environment; and preventing the global environmental problem of marine litter. The Union should, however, propose and support changes to the proposed amendments to the Annexes to the Convention proposed by Norway, with a view to clarifying the scope of those amendments and improving the text, as well as to setting an appropriate later date for application of those amendments than foreseen in Article 18 of the Convention, and thereby facilitating their implementation and enforcement.

| (7) | It is appropriate to maintain the current situation for shipments of non-hazardous plastic waste, including certain mixtures of non-hazardous plastic waste within the Union and the EEA, and therefore not to use the control system stemming from the addition of an entry in Annex II to the Convention for such shipments. To that end, the Union should, as far as necessary, use the procedures set out in the OECD Decision and the procedure for entry into bilateral, multilateral, or regional agreements or arrangements regarding transboundary movement of hazardous wastes or other wastes with Parties or non-parties in accordance with the Convention to ensure that no additional control is imposed on shipments of non-hazardous plastic waste, including certain mixtures of non-hazardous plastic waste within the Union and the EEA, as a result of the adoption of the amendment to Annex II to the Convention or the revision of entry B3010 in Annex IX to the Convention. |
| --- | --- |

(7)

It is appropriate to maintain the current situation for shipments of non-hazardous plastic waste, including certain mixtures of non-hazardous plastic waste within the Union and the EEA, and therefore not to use the control system stemming from the addition of an entry in Annex II to the Convention for such shipments. To that end, the Union should, as far as necessary, use the procedures set out in the OECD Decision and the procedure for entry into bilateral, multilateral, or regional agreements or arrangements regarding transboundary movement of hazardous wastes or other wastes with Parties or non-parties in accordance with the Convention to ensure that no additional control is imposed on shipments of non-hazardous plastic waste, including certain mixtures of non-hazardous plastic waste within the Union and the EEA, as a result of the adoption of the amendment to Annex II to the Convention or the revision of entry B3010 in Annex IX to the Convention.

| (8) | It is appropriate to establish the position to be taken on the Union's behalf at the fourteenth meeting of the Conference of the Parties concerning the amendments to Annexes II, VIII and IX to the Convention, as those amendments will be binding on the Union and are capable of decisively influencing the content of Union law, namely Regulation (EC) No 1013/2006, |
| --- | --- |

(8)

It is appropriate to establish the position to be taken on the Union's behalf at the fourteenth meeting of the Conference of the Parties concerning the amendments to Annexes II, VIII and IX to the Convention, as those amendments will be binding on the Union and are capable of decisively influencing the content of Union law, namely Regulation (EC) No 1013/2006,

HAS ADOPTED THIS DECISION:

Article 1

1.   The position to be taken on the Union's behalf at the fourteenth meeting of the Conference of the Parties to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (the ‘Convention’) shall be to support the adoption of the amendments to Annexes II, VIII and IX to the Convention to add and revise entries concerning plastic waste, subject to the following considerations:

| (a) | the Union supports the amendments proposed by Norway to add a new entry for non-hazardous plastic waste (which shall be subject to the Convention's control system) in Annex II to the Convention, provided that it is clarified that that entry also covers mixtures of non-hazardous plastic waste and that that entry is clearly defined, inter alia, by a clear wording of entry B3010 in Annex IX to the Convention, with a view to facilitating the implementation and enforcement of the obligations of the Parties in connection with the addition of the new entry for non-hazardous plastic waste in Annex II to the Convention; |
| --- | --- |

(a)

the Union supports the amendments proposed by Norway to add a new entry for non-hazardous plastic waste (which shall be subject to the Convention's control system) in Annex II to the Convention, provided that it is clarified that that entry also covers mixtures of non-hazardous plastic waste and that that entry is clearly defined, inter alia, by a clear wording of entry B3010 in Annex IX to the Convention, with a view to facilitating the implementation and enforcement of the obligations of the Parties in connection with the addition of the new entry for non-hazardous plastic waste in Annex II to the Convention;

| (b) | the Union supports the amendments proposed by Norway to add a new entry for hazardous plastic waste (which shall be subject to the control system) in Annex VIII to the Convention, provided that it is clarified that that entry also covers mixtures of hazardous plastic waste; |
| --- | --- |

(b)

the Union supports the amendments proposed by Norway to add a new entry for hazardous plastic waste (which shall be subject to the control system) in Annex VIII to the Convention, provided that it is clarified that that entry also covers mixtures of hazardous plastic waste;

| (c) | the Union supports the proposal by Norway to revise entry B3010 for non-hazardous plastic waste (which shall not be subject to the control system, unless such waste contains a material belonging to a category in Annex I to the Convention to an extent causing it to exhibit a hazardous characteristic in Annex III to the Convention) in Annex IX to the Convention, provided that that proposal is amended with a view to:






  (i) | clarifying the scope, so that only non-mixed plastic materials destined for recycling or preparation for reuse, preferably limited to operation R3 in Annex IV to the Convention, are included in the entry; |
| --- | --- | --- |

(c)

the Union supports the proposal by Norway to revise entry B3010 for non-hazardous plastic waste (which shall not be subject to the control system, unless such waste contains a material belonging to a category in Annex I to the Convention to an extent causing it to exhibit a hazardous characteristic in Annex III to the Convention) in Annex IX to the Convention, provided that that proposal is amended with a view to:

(i)

clarifying the scope, so that only non-mixed plastic materials destined for recycling or preparation for reuse, preferably limited to operation R3 in Annex IV to the Convention, are included in the entry;

| (ii) | improving the text and simplifying the definition of entry B3010 in Annex IX to the Convention, so as to facilitate the implementation and enforcement of the obligations of the Parties in connection with the revision of that entry, in particular as that entry is linked to the proposed entry for non-hazardous plastic waste in Annex II to the Convention; |
| --- | --- |

(ii)

improving the text and simplifying the definition of entry B3010 in Annex IX to the Convention, so as to facilitate the implementation and enforcement of the obligations of the Parties in connection with the revision of that entry, in particular as that entry is linked to the proposed entry for non-hazardous plastic waste in Annex II to the Convention;

| (d) | the Union proposes and supports setting an appropriate later date for application of the amendments than the date foreseen in Article 18 of the Convention. |
| --- | --- |

(d)

the Union proposes and supports setting an appropriate later date for application of the amendments than the date foreseen in Article 18 of the Convention.

2.   In case the addition of a new entry for non-hazardous plastic waste in Annex II or the revision of entry B3010 in Annex IX to the Convention, or both, are adopted at the fourteenth meeting of the Conference of the Parties to the Convention, the Union shall, as far as necessary, take the steps required under the OECD Decision and Article 11 of the Convention to ensure that the current controls on shipments of non-hazardous plastic waste, including certain mixtures of non-hazardous plastic waste within the Union and the EEA, remain unaffected.

Article 2

Refinement of the position referred to in Article 1 may be agreed to, in the light of developments at the fourteenth meeting of the Conference of the Parties, by representatives of the Union, in consultation with the Member States, during on-the-spot coordination meetings, without a further decision of the Council.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 15 April 2019.

For the Council

The President

P. DAEA

---

(1)  Council Decision 93/98/EEC of 1 February 1993 on the conclusion, on behalf of the Community, of the Convention on the control of transboundary movements of hazardous wastes and their disposal (Basel Convention) (OJ L 39, 16.2.1993, p. 1).

1

(2)  Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (OJ L 190, 12.7.2006, p. 1).

2

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/22 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/22

---

COUNCIL DECISION (EU) 2019/639

of 15 April 2019

on the position to be taken on behalf of the European Union at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Stockholm Convention on Persistent Organic Pollutants

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Stockholm Convention on Persistent Organic Pollutants (the ‘Convention’) entered into force on 17 May 2004 and was concluded by the Union by means of Council Decision 2006/507/EC (1). |
| --- | --- |

(1)

The Stockholm Convention on Persistent Organic Pollutants (the ‘Convention’) entered into force on 17 May 2004 and was concluded by the Union by means of Council Decision 2006/507/EC (1).

| (2) | Regulation (EC) No 850/2004 of the European Parliament and of the Council (2) implements the Convention within the Union. |
| --- | --- |

(2)

Regulation (EC) No 850/2004 of the European Parliament and of the Council (2) implements the Convention within the Union.

| (3) | In accordance with Article 8 of the Convention, the Conference of the Parties may list chemicals in Annexes A, B and/or C to the Convention and specify control measures related to those chemicals. |
| --- | --- |

(3)

In accordance with Article 8 of the Convention, the Conference of the Parties may list chemicals in Annexes A, B and/or C to the Convention and specify control measures related to those chemicals.

| (4) | In order to protect human health and the environment from further releases of dicofol, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, it is necessary to reduce or eliminate the production and use of those chemicals at global level and to support their listing in the relevant Annexes to the Convention. In addition, it is necessary to further reduce or eliminate the use of perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride (PFOSF), by amending or deleting the acceptable purposes and/or specific exemptions in Annex B to the Convention. |
| --- | --- |

(4)

In order to protect human health and the environment from further releases of dicofol, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, it is necessary to reduce or eliminate the production and use of those chemicals at global level and to support their listing in the relevant Annexes to the Convention. In addition, it is necessary to further reduce or eliminate the use of perfluorooctane sulfonic acid (PFOS), its salts and perfluorooctane sulfonyl fluoride (PFOSF), by amending or deleting the acceptable purposes and/or specific exemptions in Annex B to the Convention.

| (5) | At its ninth meeting, the Conference of the Parties is expected to decide whether to list those chemicals in Annex A to the Convention and to modify existing entries in Annex B to the Convention. |
| --- | --- |

(5)

At its ninth meeting, the Conference of the Parties is expected to decide whether to list those chemicals in Annex A to the Convention and to modify existing entries in Annex B to the Convention.

| (6) | It is appropriate to establish the position to be taken on the Union's behalf at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Convention, as those amendments will be binding on the Union, |
| --- | --- |

(6)

It is appropriate to establish the position to be taken on the Union's behalf at the ninth meeting of the Conference of the Parties as regards amendments to Annexes A and B to the Convention, as those amendments will be binding on the Union,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken on the Union's behalf at the ninth meeting of the Conference of the Parties to the Stockholm Convention on Persistent Organic Pollutants (the ‘Convention’), taking due account of the relevant recommendations of the Persistent Organic Pollutants Review Committee, shall be to support the:

| (a) | listing of dicofol in Annex A to the Convention without specific exemptions; |
| --- | --- |

(a)

listing of dicofol in Annex A to the Convention without specific exemptions;

| (b) | listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex A to the Convention, including the insertion of a new part [X] in Annex A to the Convention, with specific exemptions for:






  (i) | manufacture of semiconductors or related electronic devices, including for 10 years from the date of entry into force of these amendments an exemption for refurbishment parts for equipment for manufacture of semiconductors or related electronic devices; |
| --- | --- | --- |

(b)

listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex A to the Convention, including the insertion of a new part [X] in Annex A to the Convention, with specific exemptions for:

(i)

manufacture of semiconductors or related electronic devices, including for 10 years from the date of entry into force of these amendments an exemption for refurbishment parts for equipment for manufacture of semiconductors or related electronic devices;

| (ii) | photographic coatings applied to films; |
| --- | --- |

(ii)

photographic coatings applied to films;

| (iii) | textiles for oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety; |
| --- | --- |

(iii)

textiles for oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety;

| (iv) | invasive and implantable medical devices; |
| --- | --- |

(iv)

invasive and implantable medical devices;

| (v) | fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires already in installed systems, including both mobile and fixed systems; |
| --- | --- |

(v)

fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires already in installed systems, including both mobile and fixed systems;

| (vi) | use of perfluoroctyl iodide for the production of perfluorooctyl bromide for the purpose of producing pharmaceutical products until 2036, subject to regular review; |
| --- | --- |

(vi)

use of perfluoroctyl iodide for the production of perfluorooctyl bromide for the purpose of producing pharmaceutical products until 2036, subject to regular review;

| (c) | amendment of paragraph 3(b) of part [X] of Annex A to the Convention on PFOA, its salts and PFOA-related compounds: addition of ‘Testing to verify the proper functioning of an installed system that already contains fire-fighting foam that contains or may contain PFOA, its salts and PFOA-related compounds may be allowed, provided that emissions to the environment are prevented and collected effluents are disposed of in an environmentally sound manner, in accordance with Article 6(1) of the Convention.’; |
| --- | --- |

(c)

amendment of paragraph 3(b) of part [X] of Annex A to the Convention on PFOA, its salts and PFOA-related compounds: addition of ‘Testing to verify the proper functioning of an installed system that already contains fire-fighting foam that contains or may contain PFOA, its salts and PFOA-related compounds may be allowed, provided that emissions to the environment are prevented and collected effluents are disposed of in an environmentally sound manner, in accordance with Article 6(1) of the Convention.’;

| (d) | deletion of the following ‘acceptable purposes’ from the entry on perfluorooctane sulfonic acid (PFOS) and its derivatives in Annex B to the Convention: photo-imaging, photo-resist and anti-reflective coatings for semi-conductors, etching agent for compound semi-conductors and ceramic filters, aviation hydraulic fluids, certain medical devices (such as ethylene tetrafluoroethylene copolymer (ETFE) layers and radio-opaque ETFE production, in vitro diagnostic medical devices, and CCD colour filters); |
| --- | --- |

(d)

deletion of the following ‘acceptable purposes’ from the entry on perfluorooctane sulfonic acid (PFOS) and its derivatives in Annex B to the Convention: photo-imaging, photo-resist and anti-reflective coatings for semi-conductors, etching agent for compound semi-conductors and ceramic filters, aviation hydraulic fluids, certain medical devices (such as ethylene tetrafluoroethylene copolymer (ETFE) layers and radio-opaque ETFE production, in vitro diagnostic medical devices, and CCD colour filters);

| (e) | deletion of the following ‘specific exemptions’ from the entry on PFOS and its derivatives in Annex B to the Convention: photo masks in the semiconductor and liquid crystal display (LCD) industries, metal plating (hard metal plating), metal plating (decorative plating), electric and electronic parts for some colour printers and colour copy machines, insecticides for control of red imported fire ants and termites, chemically driven oil production; |
| --- | --- |

(e)

deletion of the following ‘specific exemptions’ from the entry on PFOS and its derivatives in Annex B to the Convention: photo masks in the semiconductor and liquid crystal display (LCD) industries, metal plating (hard metal plating), metal plating (decorative plating), electric and electronic parts for some colour printers and colour copy machines, insecticides for control of red imported fire ants and termites, chemically driven oil production;

| (f) | amendment of the ‘acceptable purpose’ for PFOS and its derivatives for production and use of fire-fighting foam to a ‘specific exemption’ for the use of fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires; |
| --- | --- |

(f)

amendment of the ‘acceptable purpose’ for PFOS and its derivatives for production and use of fire-fighting foam to a ‘specific exemption’ for the use of fire-fighting foam for liquid fuel vapour suppression and liquid fuel fires;

| (g) | amendment of the ‘acceptable purpose’ for PFOS and its derivatives for production and use for metal plating (hard metal plating) only in closed-loop systems to a ‘specific exemption’ for that use; |
| --- | --- |

(g)

amendment of the ‘acceptable purpose’ for PFOS and its derivatives for production and use for metal plating (hard metal plating) only in closed-loop systems to a ‘specific exemption’ for that use;

| (h) | amendment of the ‘acceptable purpose’ for PFOS and its derivatives for use in insect baits for control of leaf-cutting ants from Atta spp. and Acromyrmex spp. by including sulfluramid and specifying that the ‘acceptable purpose’ is for agricultural use only. |
| --- | --- |

(h)

amendment of the ‘acceptable purpose’ for PFOS and its derivatives for use in insect baits for control of leaf-cutting ants from Atta spp. and Acromyrmex spp. by including sulfluramid and specifying that the ‘acceptable purpose’ is for agricultural use only.

Article 2

Minor changes to the position referred to in Article 1 may be agreed to, in the light of developments at the ninth meeting of the Conference of the Parties, by representatives of the Union, in consultation with the Member States, during on-the-spot coordination meetings, without a further decision of the Council.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 15 April 2019.

For the Council

The President

P. DAEA

---

(1)  Council Decision 2006/507/EC of 14 October 2004 concerning the conclusion, on behalf of the European Community, of the Stockholm Convention on Persistent Organic Pollutants (OJ L 209, 31.7.2006, p. 1).

1

(2)  Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).

2

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/24 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/24

---

COUNCIL DECISION (EU) 2019/640

of 15 April 2019

concerning the allocation of funds decommitted from projects under the 10th European Development Fund for the purpose of replenishing the African Peace Facility

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the Internal Agreement between the Representatives of the Governments of the Member States of the European Union, meeting within the Council, on the financing of European Union aid under the multiannual financial framework for the period 2014 to 2020, in accordance with the ACP-EU Partnership Agreement, and on the allocation of financial assistance for the Overseas Countries and Territories to which Part Four of the Treaty on the Functioning of the European Union applies (1), and in particular Article 1(4) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Under the 11th European Development Fund (EDF), the Union has so far committed a total of EUR 1 627 300 000 to the African Peace Facility (APF) to provide financial support to African Union responses to ongoing and emerging security crises in Africa. This engagement in peace and security on the African continent should be sustained for the period 2019-2020. |
| --- | --- |

(1)

Under the 11th European Development Fund (EDF), the Union has so far committed a total of EUR 1 627 300 000 to the African Peace Facility (APF) to provide financial support to African Union responses to ongoing and emerging security crises in Africa. This engagement in peace and security on the African continent should be sustained for the period 2019-2020.

| (2) | APF requirements for the period 2019-2020 are estimated at EUR 814 860 000. |
| --- | --- |

(2)

APF requirements for the period 2019-2020 are estimated at EUR 814 860 000.

| (3) | It is appropriate to use decommitted funds from projects under the 10th EDF to ensure the financing of the APF up to the end of 2020. |
| --- | --- |

(3)

It is appropriate to use decommitted funds from projects under the 10th EDF to ensure the financing of the APF up to the end of 2020.

| (4) | Those funds should finance APF activities, including support for the operationalisation of the African Peace and Security Architecture, support for initiatives aimed at preventing and managing violent conflict in case of urgent and unforeseen needs in crisis situations (Early Response Mechanism) and support to African-led Peace Support Operations, and should cover support expenditure incurred by the Commission. |
| --- | --- |

(4)

Those funds should finance APF activities, including support for the operationalisation of the African Peace and Security Architecture, support for initiatives aimed at preventing and managing violent conflict in case of urgent and unforeseen needs in crisis situations (Early Response Mechanism) and support to African-led Peace Support Operations, and should cover support expenditure incurred by the Commission.

| (5) | Those funds should be used in accordance with the relevant APF multiannual action programme and with the rules and procedures applicable to the 11th EDF, as set out in Council Regulations (EU) 2015/322 (2) and (EU) 2018/1877 (3), |
| --- | --- |

(5)

Those funds should be used in accordance with the relevant APF multiannual action programme and with the rules and procedures applicable to the 11th EDF, as set out in Council Regulations (EU) 2015/322 (2) and (EU) 2018/1877 (3),

HAS ADOPTED THIS DECISION:

Article 1

An amount up to a maximum of EUR 445 860 000 from the funds decommitted from projects under the 10th European Development Fund (EDF) shall be allocated for the purpose of replenishing the African Peace Facility for the period 2019-2020.

From that amount, up to a maximum of EUR 14 860 000 shall be allocated for support expenditure incurred by the Commission.

Those funds shall be used in accordance with the rules and procedures applicable to the 11th EDF.

Article 2

This Decision shall enter into force on the day following that of its adoption.

Done at Luxembourg, 15 April 2019.

For the Council

The President

P. DAEA

---

(1)  
  OJ L 210, 6.8.2013, p. 1.

1

(2)  Council Regulation (EU) 2015/322 of 2 March 2015 on the implementation of the 11th European Development Fund (OJ L 58, 3.3.2015, p. 1).

2

(3)  Council Regulation (EU) 2018/1877 of 26 November 2018 on the financial regulation applicable to the 11th European Development Fund, and repealing Regulation (EU) 2015/323 (OJ L 307, 3.12.2018, p. 1).

3

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/26 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/26

---

COMMISSION IMPLEMENTING DECISION (EU) 2019/641

of 17 April 2019

on the terms and conditions of the authorisation of a biocidal product family containing 1R-trans phenothrin referred by Ireland in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council

(notified under document C(2019) 2837)

(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 36(3) thereof,

Whereas:

| (1) | On 20 August 2015, the company CSI-Europe (‘the applicant’) submitted an application to the competent authorities of a number of Member States, including Germany, (‘the Member States concerned’) for mutual recognition in parallel of a biocidal product family of bait-based insecticides against ants containing the active substance 1R-trans phenothrin (‘the contested product family’). Ireland acted as the Member State responsible for the evaluation of the application as referred to in Article 34(1) of Regulation (EU) No 528/2012 (‘the reference Member State’). |
| --- | --- |

(1)

On 20 August 2015, the company CSI-Europe (‘the applicant’) submitted an application to the competent authorities of a number of Member States, including Germany, (‘the Member States concerned’) for mutual recognition in parallel of a biocidal product family of bait-based insecticides against ants containing the active substance 1R-trans phenothrin (‘the contested product family’). Ireland acted as the Member State responsible for the evaluation of the application as referred to in Article 34(1) of Regulation (EU) No 528/2012 (‘the reference Member State’).

| (2) | Pursuant to Article 35(2) of Regulation (EU) No 528/2012, Germany referred objections to the coordination group on 30 June 2017 and to the applicant, indicating that the contested product family does not meet the condition laid down in Article 19(1)(b)(i) of that Regulation. |
| --- | --- |

(2)

Pursuant to Article 35(2) of Regulation (EU) No 528/2012, Germany referred objections to the coordination group on 30 June 2017 and to the applicant, indicating that the contested product family does not meet the condition laid down in Article 19(1)(b)(i) of that Regulation.

| (3) | Germany considers that the efficacy data provided by the applicant and evaluated by the reference Member State are not acceptable. Germany questions whether the palatability of the bait products was sufficiently demonstrated in the laboratory tests. It also questions the validity of the field study, since it was not performed during spring time, as well as the validity of the statistical analysis performed by the applicant. Moreover, Germany disagrees with the judgments made by the reference Member State based on expert advice, as referred to in point 12 of Annex VI to Regulation (EU) No 528/2012. |
| --- | --- |

(3)

Germany considers that the efficacy data provided by the applicant and evaluated by the reference Member State are not acceptable. Germany questions whether the palatability of the bait products was sufficiently demonstrated in the laboratory tests. It also questions the validity of the field study, since it was not performed during spring time, as well as the validity of the statistical analysis performed by the applicant. Moreover, Germany disagrees with the judgments made by the reference Member State based on expert advice, as referred to in point 12 of Annex VI to Regulation (EU) No 528/2012.

| (4) | The coordination group secretariat invited the Member States concerned and the applicant to submit written comments about the referral. Belgium, Germany, Luxembourg, the Netherlands, the United Kingdom and the applicant submitted comments. The referral was also discussed in the meeting of the coordination group on 26 September 2017. |
| --- | --- |

(4)

The coordination group secretariat invited the Member States concerned and the applicant to submit written comments about the referral. Belgium, Germany, Luxembourg, the Netherlands, the United Kingdom and the applicant submitted comments. The referral was also discussed in the meeting of the coordination group on 26 September 2017.

| (5) | As no agreement was reached in the coordination group, the reference Member State referred the unresolved objections to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 16 January 2018. The reference Member State thereby provided the Commission with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement. A copy of that statement was forwarded to the Member States concerned and the applicant. |
| --- | --- |

(5)

As no agreement was reached in the coordination group, the reference Member State referred the unresolved objections to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 16 January 2018. The reference Member State thereby provided the Commission with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement. A copy of that statement was forwarded to the Member States concerned and the applicant.

| (6) | On 16 February 2018, the Commission requested an opinion from the European Chemicals Agency (‘the Agency’) pursuant to Article 36(2) of Regulation (EU) No 528/2012 on a number of questions concerning the unresolved objections. |
| --- | --- |

(6)

On 16 February 2018, the Commission requested an opinion from the European Chemicals Agency (‘the Agency’) pursuant to Article 36(2) of Regulation (EU) No 528/2012 on a number of questions concerning the unresolved objections.

| (7) | The Agency adopted its opinion (2) on 18 October 2018. |
| --- | --- |

(7)

The Agency adopted its opinion (2) on 18 October 2018.

| (8) | According to the Agency, the palatability of the bait products covered by the contested product family is sufficiently demonstrated for the claimed use. |
| --- | --- |

(8)

According to the Agency, the palatability of the bait products covered by the contested product family is sufficiently demonstrated for the claimed use.

| (9) | Furthermore, the Agency indicates in its opinion that the field study is valid, since it shows a greater reduction in ant population in the treated nests compared to the control nests. Moreover, the Agency considers that the statistical analysis of the results of the field study performed by the applicant is acceptable. Taking into account the agreed Union guidance (3) applicable at the time of submission of the application, the Agency concludes that the efficacy of the contested product family for the claimed use is sufficiently demonstrated by the field data provided by the applicant. |
| --- | --- |

(9)

Furthermore, the Agency indicates in its opinion that the field study is valid, since it shows a greater reduction in ant population in the treated nests compared to the control nests. Moreover, the Agency considers that the statistical analysis of the results of the field study performed by the applicant is acceptable. Taking into account the agreed Union guidance (3) applicable at the time of submission of the application, the Agency concludes that the efficacy of the contested product family for the claimed use is sufficiently demonstrated by the field data provided by the applicant.

| (10) | In light of the opinion of the Agency, the contested product family is sufficiently effective as required under Article 19(1)(b)(i) of Regulation (EU) No 528/2012. |
| --- | --- |

(10)

In light of the opinion of the Agency, the contested product family is sufficiently effective as required under Article 19(1)(b)(i) of Regulation (EU) No 528/2012.

| (11) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(11)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS DECISION:

Article 1

This Decision applies to the biocidal product family identified by the case number BC-LR019221-36 in the Register for Biocidal Products.

Article 2

The biocidal product family referred to in Article 1 meets the condition laid down in Article 19(1)(b)(i) of Regulation (EU) No 528/2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 17 April 2019.

For the Commission

Jyrki KATAINEN

Vice-President

---

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

1

(2)  ECHA opinion of 18 October 2018 on a request according to Article 38 of Regulation (EU) No 528/2012 on ‘Questions on unresolved objections during mutual recognition of a PT 18 biocidal product family containing 1R-trans phenothrin for use against ants’ (ECHA/BPC/216/2018).

2

(3)  Technical Notes for Guidance on product evaluation (2012) — Efficacy tests for product type 18 —insecticides, acaricides and products to control other arthropods and product type 19 — repellents and attractants (only concerning arthropods).

3

https://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg_efficacy_pt18-19_final_en.pdf/9c72241e-0eea-4f23-8e5f-f52d00a83382

---

Corrigenda

| 24.4.2019 | EN | Official Journal of the European Union | L 109/28 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/28

---

Corrigendum to Commission Implementing Regulation (EU) 2018/1506 of 10 October 2018 on exceptional market support measures for the eggs and poultrymeat sectors in Italy

(
  Official Journal of the European Union L 255 of 11 October 2018
  )

On page 4, in point (i) of Article 3(1)(d):

for:

‘EUR 0,1815 per broiler falling within the CN code 0105 94 00 up to a maximum of 853 692 animals,’,

read:

‘EUR 0,1815 per week per broiler falling within the CN code 0105 94 00 up to a maximum of 853 692 animals,’.

On page 4, in point (ii) of Article 3(1)(d):

for:

‘EUR 1,2225 per turkey falling within the CN code 0105 99 30 up to a maximum of 48 050 animals.’

read:

‘EUR 1,2225 per week per turkey falling within the CN code 0105 99 30 up to a maximum of 48 050 animals.’.

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/28 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/28

---

Corrigendum to Commission Regulation (EU) 2019/50 of 11 January 2019 amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorantraniliprole, clomazone, cyclaniliprole, fenazaquin, fenpicoxamid, fluoxastrobin, lambda-cyhalothrin, mepiquat, onion oil, thiacloprid and valifenalate in or on certain products

(
  Official Journal of the European Union L 10 of 14.1.2019
  )

On page 12, in the Annex, in the amendments to the columns for clomazone, fluoxastrobin, lambda-cyhalothrin, mepiquat and thiacloprid in Annex II to Regulation (EC) No 396/2005, in the table, in the heading for the column for lambda-cyhalothrin:

for:

‘Lambda-Cyhalothrin (F) (R)’,

read:

‘Lambda-cyhalothrin (includes gamma-cyhalothrin) (sum of R,S and S,R isomers) (F)’.

On page 17, in the Annex, in the amendments to the columns for clomazone, fluoxastrobin, lambda-cyhalothrin, mepiquat and thiacloprid in Annex II to Regulation (EC) No 396/2005, in the table, in the entry for cotton seeds:

for:

| ‘0401090 | Cotton seeds | | 0,01 (*) | 0,2 | 0,5 (+) | 0,15’ |
| --- | --- | --- | --- | --- | --- | --- |

‘0401090

Cotton seeds

0,01 (*)

0,2

0,5 (+)

0,15’

read:

| ‘0401090 | Cotton seeds | | 0,01 (*) | 0,2 | 5 (+) | 0,15’ |
| --- | --- | --- | --- | --- | --- | --- |

‘0401090

Cotton seeds

0,01 (*)

0,2

5 (+)

0,15’

On page 22, in the Annex, in the amendments to the columns for clomazone, fluoxastrobin, lambda-cyhalothrin, mepiquat and thiacloprid in Annex II to Regulation (EC) No 396/2005, in the footnotes below the table:

for:

‘
  Lambda-Cyhalothrin (F) (R)

| (R) | = | The residue definition differs for the following combinations pesticide-code number:
  Lambda-Cyhalothrin - code 1000000 except 1040000: Lambda-cyhalothrin, including other mixed isomeric consituents (sum of isomers)’, |
| --- | --- | --- |

(R)

=

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

Lambda-Cyhalothrin - code 1000000 except 1040000: Lambda-cyhalothrin, including other mixed isomeric consituents (sum of isomers)’,

read:

‘
  Lambda-cyhalothrin (includes gamma-cyhalothrin) (sum of R,S and S,R isomers) (F)
  ’.

---

| 24.4.2019 | EN | Official Journal of the European Union | L 109/29 |
| --- | --- | --- | --- |

24.4.2019

EN

Official Journal of the European Union

L 109/29

---

Corrigendum to Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16 (1) of Directive 87/391/EEC)

(
  Official Journal of the European Union L 156 of 21 June 1990
  )

On page 14, title of the Directive:

for:

‘Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16(1) of Directive 87/391/EEC)’,

read:

‘Council Directive 90/270/EEC of 29 May 1990 on the minimum safety and health requirements for work with display screen equipment (fifth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)’.

---