# Official Journal L 249/2018

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 249 |
| | |
| English edition | Legislation | Volume 614 October 2018 |

ISSN 1977-0677

Official Journal

of the European Union

L 249

English edition

Legislation

Volume 614 October 2018

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2018/1476 of 3 October 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq | 1 |
| | | DECISIONS |
| | * | Commission Implementing Decision (EU) 2018/1477 of 2 October 2018 on the terms and conditions of the authorisations of biocidal products containing ethyl butylacetylaminopropionate referred by Belgium in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
  (notified under document C(2018) 6291)

   (
  1
  ) | 3 |
| | * | Commission Implementing Decision (EU) 2018/1478 of 3 October 2018 amending Implementing Decision (EU) 2016/2323 to update the European List of ship recycling facilities established pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council (
  1
  ) | 6 |
| | * | Commission Implementing Decision (EU) 2018/1479 of 3 October 2018 postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 (
  1
  ) | 16 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2018/1476 of 3 October 2018 amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

1

DECISIONS

*

Commission Implementing Decision (EU) 2018/1477 of 2 October 2018 on the terms and conditions of the authorisations of biocidal products containing ethyl butylacetylaminopropionate referred by Belgium in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
  (notified under document C(2018) 6291)

   (
  1
  )

(notified under document C(2018) 6291)

1

3

*

Commission Implementing Decision (EU) 2018/1478 of 3 October 2018 amending Implementing Decision (EU) 2016/2323 to update the European List of ship recycling facilities established pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council (
  1
  )

1

6

*

Commission Implementing Decision (EU) 2018/1479 of 3 October 2018 postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 (
  1
  )

1

16

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether ( OJ L 35, 10.2.2017 ) | 18 |

Corrigenda

*

Corrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether ( OJ L 35, 10.2.2017 )

( OJ L 35, 10.2.2017 )

18

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

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(1)   Text with EEA relevance.

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 4.10.2018 | EN | Official Journal of the European Union | L 249/1 |
| --- | --- | --- | --- |

4.10.2018

EN

Official Journal of the European Union

L 249/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2018/1476

of 3 October 2018

amending Council Regulation (EC) No 1210/2003 concerning certain specific restrictions on economic and financial relations with Iraq

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1210/2003 of 7 July 2003 concerning certain specific restrictions on economic and financial relations with Iraq and repealing Regulation (EC) No 2465/96 (1), and in particular Article 11(b) thereof,

Whereas:

| (1) | Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation. |
| --- | --- |

(1)

Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

| (2) | On 28 September 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply. |
| --- | --- |

(2)

On 28 September 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply.

| (3) | Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly, |
| --- | --- |

(3)

Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex III to Regulation (EC) No 1210/2003 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 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, 3 October 2018.

For the Commission,

On behalf of the President,

Head of the Service for Foreign Policy Instruments

---

(1)  
  OJ L 169, 8.7.2003, p. 6.

1

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ANNEX

In Annex III to Council Regulation (EC) No 1210/2003, the following entry is deleted:

| ‘128. | STATE ENTERPRISE FOR AUTOMOTIVE INDUSTRY (alias STATE ENTERPRISE FOR AUTOMOTIVE INDUSTRIES). Address: P.O. Box 138, Iskandariya-Babylon, Iraq.’ |
| --- | --- |

‘128.

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DECISIONS

| 4.10.2018 | EN | Official Journal of the European Union | L 249/3 |
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4.10.2018

EN

Official Journal of the European Union

L 249/3

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COMMISSION IMPLEMENTING DECISION (EU) 2018/1477

of 2 October 2018

on the terms and conditions of the authorisations of biocidal products containing ethyl butylacetylaminopropionate referred by Belgium in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council

(notified under document C(2018) 6291)

(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 16 December 2014, the company Merck KGaA (‘the applicant’) submitted an application for mutual recognition in parallel of two insect repellents applied on humans against mosquitoes and ticks containing the active substance ethyl butylacetylaminopropionate in the form of a pump spray and an aerosol, respectively (‘the contested products’) to the competent authority of Belgium (‘the reference Member State’) in accordance with Article 34(1) of Regulation (EU) No 528/2012. At the same time, the applicant submitted applications for mutual recognition of the contested products to a number of Member States, including the United Kingdom, in accordance with Article 34(2) of that Regulation. |
| --- | --- |

(1)

On 16 December 2014, the company Merck KGaA (‘the applicant’) submitted an application for mutual recognition in parallel of two insect repellents applied on humans against mosquitoes and ticks containing the active substance ethyl butylacetylaminopropionate in the form of a pump spray and an aerosol, respectively (‘the contested products’) to the competent authority of Belgium (‘the reference Member State’) in accordance with Article 34(1) of Regulation (EU) No 528/2012. At the same time, the applicant submitted applications for mutual recognition of the contested products to a number of Member States, including the United Kingdom, in accordance with Article 34(2) of that Regulation.

| (2) | Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the United Kingdom referred objections to the coordination group on 14 February 2017 and to the applicant, indicating that the contested products do not meet the conditions laid down in Article 19(1)(b) of that Regulation. |
| --- | --- |

(2)

Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the United Kingdom referred objections to the coordination group on 14 February 2017 and to the applicant, indicating that the contested products do not meet the conditions laid down in Article 19(1)(b) of that Regulation.

| (3) | The United Kingdom considers that the assessment of the applications has not been correctly carried out by the reference Member State, since there is a discrepancy between the application rate used in the efficacy studies and the application rate used in the exposure assessment, which is lower (‘the discrepancy’). |
| --- | --- |

(3)

The United Kingdom considers that the assessment of the applications has not been correctly carried out by the reference Member State, since there is a discrepancy between the application rate used in the efficacy studies and the application rate used in the exposure assessment, which is lower (‘the discrepancy’).

| (4) | The coordination group secretariat invited the other Member States concerned and the applicant to submit written comments about the referral. Denmark, Germany, Latvia and the applicant submitted comments. The referral was also discussed in the coordination group's meetings of 14 March 2017 and 10 May 2017. |
| --- | --- |

(4)

The coordination group secretariat invited the other Member States concerned and the applicant to submit written comments about the referral. Denmark, Germany, Latvia and the applicant submitted comments. The referral was also discussed in the coordination group's meetings of 14 March 2017 and 10 May 2017.

| (5) | As no agreement was reached in the coordination group, the reference Member State referred the unresolved objection to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 18 July 2017. It hereby 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 objection to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012 on 18 July 2017. It hereby 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) | The reference Member State, Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Latvia, Lithuania, Malta, The Netherlands, Spain and Sweden authorised the relevant contested product in the period from 16 May 2017 to 6 March 2018, pursuant to Article 34(7) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

The reference Member State, Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Latvia, Lithuania, Malta, The Netherlands, Spain and Sweden authorised the relevant contested product in the period from 16 May 2017 to 6 March 2018, pursuant to Article 34(7) of Regulation (EU) No 528/2012.

| (7) | On 7 September 2017, 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 discrepancy. |
| --- | --- |

(7)

On 7 September 2017, 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 discrepancy.

| (8) | The Agency (the Biocidal Products Committee) adopted its opinion (2) on 12 December 2017. |
| --- | --- |

(8)

The Agency (the Biocidal Products Committee) adopted its opinion (2) on 12 December 2017.

| (9) | According to the Agency, the approach followed by the reference Member State, namely to accept the discrepancy, is not appropriate when verifying whether the conditions in Article 19(1)(b) of Regulation (EU) No 528/2012 are satisfied. The Agency considers that either the available information is not sufficient to demonstrate that the contested products, when used at the lower application rates, are sufficiently effective or unacceptable effects on the health of humans are identified, when the contested products are used at the higher application rates derived from the efficacy studies. |
| --- | --- |

(9)

According to the Agency, the approach followed by the reference Member State, namely to accept the discrepancy, is not appropriate when verifying whether the conditions in Article 19(1)(b) of Regulation (EU) No 528/2012 are satisfied. The Agency considers that either the available information is not sufficient to demonstrate that the contested products, when used at the lower application rates, are sufficiently effective or unacceptable effects on the health of humans are identified, when the contested products are used at the higher application rates derived from the efficacy studies.

| (10) | The Agency emphasises in its opinion the general principle that the application rate proven efficacious should be considered for the exposure assessment. Using the application rate derived from the efficacy studies in the exposure assessment for the contested products results in an unacceptable risk for human health with regard to a number of the intended uses. |
| --- | --- |

(10)

The Agency emphasises in its opinion the general principle that the application rate proven efficacious should be considered for the exposure assessment. Using the application rate derived from the efficacy studies in the exposure assessment for the contested products results in an unacceptable risk for human health with regard to a number of the intended uses.

| (11) | In light of the opinion of the Agency, the condition laid down in Article 19(1)(b)(iii) of Regulation (EU) No 528/2012 cannot be considered to be met for any of the intended uses of the aerosol contested product, nor for the intended use of the pump spray contested product for infants under one year of age. Such uses can therefore only be authorised in accordance with Article 19(5) of that Regulation in those Member States in which the condition laid down in the first subparagraph of Article 19(5) is met. |
| --- | --- |

(11)

In light of the opinion of the Agency, the condition laid down in Article 19(1)(b)(iii) of Regulation (EU) No 528/2012 cannot be considered to be met for any of the intended uses of the aerosol contested product, nor for the intended use of the pump spray contested product for infants under one year of age. Such uses can therefore only be authorised in accordance with Article 19(5) of that Regulation in those Member States in which the condition laid down in the first subparagraph of Article 19(5) is met.

| (12) | However, pursuant to point 77 of Annex VI to Regulation (EU) No 528/2012, the recommended application rate should be the minimum necessary to achieve the desired effect. An unnecessarily high application rate would be inconsistent with the principle of proper use referred to in the second subparagraph of Article 17(5) of that Regulation. |
| --- | --- |

(12)

However, pursuant to point 77 of Annex VI to Regulation (EU) No 528/2012, the recommended application rate should be the minimum necessary to achieve the desired effect. An unnecessarily high application rate would be inconsistent with the principle of proper use referred to in the second subparagraph of Article 17(5) of that Regulation.

| (13) | The Agency also points out in its opinion that there is no precise agreed Union guidance on how to generate efficacy data for insect repellents when using the recommended application rates. Work on developing such Union guidance has already started but time to conclude is needed in order to enable applicants to generate data to demonstrate the efficacy of a product in a predictable manner. |
| --- | --- |

(13)

The Agency also points out in its opinion that there is no precise agreed Union guidance on how to generate efficacy data for insect repellents when using the recommended application rates. Work on developing such Union guidance has already started but time to conclude is needed in order to enable applicants to generate data to demonstrate the efficacy of a product in a predictable manner.

| (14) | The Agency refers in its opinion to an agreement reached by the coordination group in accordance with Article 35(3) of Regulation (EU) No 528/2012 on certain other insect repellents containing a different active substance (3). For those products, the discrepancy was accepted by all Member States concerned under the condition that it would be addressed when the product authorisations are renewed and new Union guidance is available. It is also mentioned in the opinion that this precedent may have led to a misunderstanding by the applicant and the reference Member State regarding the efficacy data requirements for insect repellents. |
| --- | --- |

(14)

The Agency refers in its opinion to an agreement reached by the coordination group in accordance with Article 35(3) of Regulation (EU) No 528/2012 on certain other insect repellents containing a different active substance (3). For those products, the discrepancy was accepted by all Member States concerned under the condition that it would be addressed when the product authorisations are renewed and new Union guidance is available. It is also mentioned in the opinion that this precedent may have led to a misunderstanding by the applicant and the reference Member State regarding the efficacy data requirements for insect repellents.

| (15) | Pursuant to Article 22(1) of Regulation (EU) No 528/2012, an authorisation of a biocidal product shall stipulate the terms and conditions relating to the making available on the market and use of the product. Those terms and conditions may include a requirement for the authorisation holder to provide additional information and, where relevant, to submit an application for a change of the authorisation in accordance with Commission Implementing Regulation (EU) No 354/2013 (4) within a given deadline. |
| --- | --- |

(15)

Pursuant to Article 22(1) of Regulation (EU) No 528/2012, an authorisation of a biocidal product shall stipulate the terms and conditions relating to the making available on the market and use of the product. Those terms and conditions may include a requirement for the authorisation holder to provide additional information and, where relevant, to submit an application for a change of the authorisation in accordance with Commission Implementing Regulation (EU) No 354/2013 (4) within a given deadline.

| (16) | It is necessary to maintain sufficient availability of insect repellents containing different active substances to minimise the occurrence of resistance in the target harmful organisms and a level playing field with regard to the generation of efficacy data at the recommended application rate should apply for all applicants and/or authorisation holders, irrespective of the involved active substances in their products. The recommended application rate should be the minimum necessary to achieve the desired effect of the insect repellent in accordance with the principle of proper use. |
| --- | --- |

(16)

It is necessary to maintain sufficient availability of insect repellents containing different active substances to minimise the occurrence of resistance in the target harmful organisms and a level playing field with regard to the generation of efficacy data at the recommended application rate should apply for all applicants and/or authorisation holders, irrespective of the involved active substances in their products. The recommended application rate should be the minimum necessary to achieve the desired effect of the insect repellent in accordance with the principle of proper use.

| (17) | Consequently, authorisations of the contested products should include a condition that the authorisation holder provides new data to confirm the efficacy of the products at the proposed application rate when Union guidance on how to generate efficacy data at the recommended application rates has been published by the Agency. The authorisation holder should be allowed sufficient time to generate the new data in accordance with that guidance. |
| --- | --- |

(17)

Consequently, authorisations of the contested products should include a condition that the authorisation holder provides new data to confirm the efficacy of the products at the proposed application rate when Union guidance on how to generate efficacy data at the recommended application rates has been published by the Agency. The authorisation holder should be allowed sufficient time to generate the new data in accordance with that guidance.

| (18) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(18)

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 products identified by the asset numbers BE-0012319-0000 and BE-0012317-0000 in the Register for Biocidal Products.

Article 2

When applying the application rate derived from the efficacy studies, the biocidal products referred to in Article 1 meet the condition laid down in Article 19(1)(b)(i) of Regulation (EU) No 528/2012 but not the condition laid down in Article 19(1)(b)(iii) of that Regulation for all intended uses.

As a consequence, the intended uses of the aerosol contested product and the intended use of the pump spray contested product for infants under 1 year of age may only be authorised in accordance with Article 19(5) of that Regulation.

The reference Member State shall update the product assessment report referred to in Article 30(3)(a) of Regulation (EU) No 528/2012 accordingly.

Article 3

When granting or amending product authorisations for the biocidal products referred to in Article 1 in accordance with Article 19(1) of Regulation (EU) No 528/2012 and, where relevant, Article 19(5) of that Regulation, Member States shall include the following condition:

‘Within two years of the publication by the European Chemicals Agency of Union guidance on how to generate efficacy data for insect repellents at the recommended application rates, the authorisation holder shall submit data to confirm the minimum effective application rate. Those data shall be submitted in the form of an application for a change of the authorisation in accordance with Commission Implementing Regulation (EU) No 354/2013’.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 2 October 2018.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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

1

(2)  ECHA opinion of 12 December 2017 on a request according to Article 38 of Regulation (EU) No 528/2012 on unresolved objections during the mutual recognition of two IR3535 containing insect repellents (ECHA/BPC/179/2017).

2

(3)  https://webgate.ec.europa.eu/echa-scircabc/w/browse/021936d9-856a-4c7f-b559-a63c19cf6fd3

3

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).

4

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| 4.10.2018 | EN | Official Journal of the European Union | L 249/6 |
| --- | --- | --- | --- |

4.10.2018

EN

Official Journal of the European Union

L 249/6

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COMMISSION IMPLEMENTING DECISION (EU) 2018/1478

of 3 October 2018

amending Implementing Decision (EU) 2016/2323 to update the European List of ship recycling facilities established pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council

(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 1257/2013 of the European Parliament and of the Council of 20 November 2013 on ship recycling and amending Regulation (EC) No 1013/2006 and Directive 2009/16/EC (1), and in particular Article 16(4) thereof,

Whereas:

| (1) | The European List of ship recycling facilities (‘the European List’) was established by Commission Implementing Decision (EU) 2016/2323 (2) and has been amended by Commission Implementing Decision (EU) 2018/684 (3). |
| --- | --- |

(1)

The European List of ship recycling facilities (‘the European List’) was established by Commission Implementing Decision (EU) 2016/2323 (2) and has been amended by Commission Implementing Decision (EU) 2018/684 (3).

| (2) | The United Kingdom has informed the Commission that a ship recycling facility located in its territory has been authorised by the competent authority in accordance with Article 14 of Regulation (EU) No 1257/2013 and has provided the Commission with all information necessary for that facility to be included in the European List. |
| --- | --- |

(2)

The United Kingdom has informed the Commission that a ship recycling facility located in its territory has been authorised by the competent authority in accordance with Article 14 of Regulation (EU) No 1257/2013 and has provided the Commission with all information necessary for that facility to be included in the European List.

| (3) | The authorisation of two ship recycling facilities located in Poland expired on 28 April 2018 and the Commission has not received information from Poland that the authorisations granted to those facilities to conduct ship recycling have been, or would be, renewed. Therefore, the two facilities no longer meet the requirements set out in Article 13(1)(a) of Regulation (EU) No 1257/2013 and should be removed from the European List in accordance with point (ii) of Article 16(4)(b) of Regulation (EU) No 1257/2013. |
| --- | --- |

(3)

The authorisation of two ship recycling facilities located in Poland expired on 28 April 2018 and the Commission has not received information from Poland that the authorisations granted to those facilities to conduct ship recycling have been, or would be, renewed. Therefore, the two facilities no longer meet the requirements set out in Article 13(1)(a) of Regulation (EU) No 1257/2013 and should be removed from the European List in accordance with point (ii) of Article 16(4)(b) of Regulation (EU) No 1257/2013.

| (4) | It is therefore appropriate to amend Implementing Decision (EU) 2016/2323. |
| --- | --- |

(4)

It is therefore appropriate to amend Implementing Decision (EU) 2016/2323.

| (5) | As regards ship recycling facilities located in a third country for which an application for inclusion in the European List has been submitted to the Commission in accordance with Article 15 of Regulation (EU) No 1257/2013, the assessment of the relevant information and supporting evidence provided or gathered is still ongoing. The Commission is to adopt implementing acts pertaining to those ship recycling facilities located outside the Union once the assessment is finalised. |
| --- | --- |

(5)

As regards ship recycling facilities located in a third country for which an application for inclusion in the European List has been submitted to the Commission in accordance with Article 15 of Regulation (EU) No 1257/2013, the assessment of the relevant information and supporting evidence provided or gathered is still ongoing. The Commission is to adopt implementing acts pertaining to those ship recycling facilities located outside the Union once the assessment is finalised.

| (6) | The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 25 of Regulation (EU) No 1257/2013, |
| --- | --- |

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 25 of Regulation (EU) No 1257/2013,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Implementing Decision (EU) 2016/2323 is replaced by the text in the Annex to this Decision.

Article 2

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

Done at Brussels, 3 October 2018.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  
  OJ L 330, 10.12.2013, p. 1.

1

(2)  Commission Implementing Decision (EU) 2016/2323 of 19 December 2016 establishing the European List of ship recycling facilities pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council on ship recycling (OJ L 345, 20.12.2016, p. 119).

2

(3)  Commission Implementing Decision (EU) 2018/684 of 4 May 2018 amending Implementing Decision (EU) 2016/2323 to update the European List of ship recycling facilities pursuant to Regulation (EU) No 1257/2013 of the European Parliament and of the Council (OJ L 116, 7.5.2018, p. 47).

3

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ANNEX

THE EUROPEAN LIST OF SHIP RECYCLING FACILITIES REFERRED TO IN ARTICLE 16(1) OF REGULATION (EU) No 1257/2013

Ship recycling facilities located in a Member State of the Union

| Name of the facility | Method of recycling | Type and size of ships that can be recycled | Limitations and conditions under which the ship recycling facility operates, including as regards hazardous waste management | Details on the explicit or tacit procedure for the approval of the ship recycling plan by the competent authority (1) | Maximum annual ship recycling output, calculated as the sum of the weight of ships expressed in LDT that have been recycled in a given year in that facility (2) | Date of expiry of inclusion in the European List (3) |
| --- | --- | --- | --- | --- | --- | --- |
| BELGIUM |
| NV Galloo Recycling Ghent |
| Scheepszatestraat 9 |
| 9000 Gent |
| BELGIUM |

Name of the facility

Method of recycling

Type and size of ships that can be recycled

Limitations and conditions under which the ship recycling facility operates, including as regards hazardous waste management

Details on the explicit or tacit procedure for the approval of the ship recycling plan by the competent authority (1)

Maximum annual ship recycling output, calculated as the sum of the weight of ships expressed in LDT that have been recycled in a given year in that facility (2)

Date of expiry of inclusion in the European List (3)

BELGIUM

NV Galloo Recycling Ghent

Scheepszatestraat 9

9000 Gent

BELGIUM

Phone: +32 92512521

Email: peter.wyntin@galloo.com

Alongside (wet berth), slope

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 265 meters |
| --- | --- |

Length: 265 meters

| | Width: 36 meters |
| --- | --- |

Width: 36 meters

| | Draught: 12,5 meters |
| --- | --- |

Draught: 12,5 meters

Tacit approval, with a maximum review period of 30 days

34 000  (4)

31 March 2020

DENMARK

| Fornæs ApS |
| --- |
| Rolshøjvej 12-16 |
| 8500 Grenå |
| DENMARK |

Fornæs ApS

Rolshøjvej 12-16

8500 Grenå

DENMARK

www.fornaes.dk

Dismantling by quay and subsequent scrapping on impermeable floors with effective drainage systems

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 150 meters |
| --- | --- |

Length: 150 meters

| | Width: 25 meters |
| --- | --- |

Width: 25 meters

| | Draught: 6 meters |
| --- | --- |

Draught: 6 meters

| | GT: 10 000 |
| --- | --- |

GT: 10 000

The municipality of Norddjurs has the right to allocate Hazardous waste for environmentally approved reception facilities.

Tacit approval, maximum review period of 14 days

30 000  (5)

30 June 2021

| Smedegaarden A/S |
| --- |
| Vikingkaj 5 |
| 6700 Esbjerg |
| DENMARK |

Smedegaarden A/S

Vikingkaj 5

6700 Esbjerg

DENMARK

www.smedegaarden.net

Dismantling by quay and subsequent scrapping on impermeable floors with effective drainage systems

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 170 meters |
| --- | --- |

Length: 170 meters

| | Width: 40 meters |
| --- | --- |

Width: 40 meters

| | Draught: 7,5 meters |
| --- | --- |

Draught: 7,5 meters

Tacit approval, maximum review period of 14 days

20 000  (6)

15 September 2021

ESTONIA

OÜ BLRT Refonda Baltic

Afloat at the quayside and in the floating dock

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 197 meters |
| --- | --- |

Length: 197 meters

| | Width: 32 meters |
| --- | --- |

Width: 32 meters

| | Draught: 9,6 meters |
| --- | --- |

Draught: 9,6 meters

| | GT: 28 000 |
| --- | --- |

GT: 28 000

Waste permit No. L.JÄ/327249. Hazardous waste management licence No 0222. Rules of the Vene-Balti Port, Manual on Ships Recycling MSR-Refonda. Environmental Management System, Waste management EP 4.4.6-1-13

The facility can recycle only these hazardous materials for which it has been licensed.

Tacit approval, with a maximum review period of 30 days.

21 852  (7)

15 February 2021

SPAIN

| DDR VESSELS XXI, S.L. |
| --- |
| Port of ‘El Musel’ |
| Gijon |
| SPAIN |

DDR VESSELS XXI, S.L.

Port of ‘El Musel’

Gijon

SPAIN

Phone: +34 630144416

Email: abarredo@ddr-vessels.com

Dismantling ramp

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013, except nuclear ships.

Maximum ship dimensions:

Length: 84,95 meters

(Ships up to 169,9 meters which can operate a zero rollover or negative ramp movement may be accepted depending on the outcome of a detailed feasibility study)

The limitations are included in the integrated environmental authorisation.

No express procedure defined yet.

0 (8)

28 July 2020

FRANCE

| Démonaval Recycling |
| --- |
| ZI du Malaquis |
| Rue François Arago |
| 76580 LE TRAIT |
| FRANCE |

Démonaval Recycling

ZI du Malaquis

Rue François Arago

76580 LE TRAIT

FRANCE

Phone: + 33 769791280

Email: patrick@demonaval-recycling.fr

Alongside, drydock

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions (drydock):

| | Length: 140 meters |
| --- | --- |

Length: 140 meters

| | Width: 25 meters |
| --- | --- |

Width: 25 meters

| | Depth: 5 meters |
| --- | --- |

Depth: 5 meters

Environmental limitations are defined in the prefectural authorisation.

Explicit approval – The competent authority for the approval decision is the minister of environment

0 (9)

11 December 2022

| Gardet & De Bezenac Recycling/Groupe BAUDELET ENVIRONNEMENT – GIE MUG |
| --- |
| 616, Boulevard Jules Durand |
| 76600 Le Havre |
| FRANCE |

Gardet & De Bezenac Recycling/Groupe BAUDELET ENVIRONNEMENT – GIE MUG

616, Boulevard Jules Durand

76600 Le Havre

FRANCE

Phone: +33 235951634

Email: infos@gardet-bezenac.com

Floating and slipway

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 150 meters |
| --- | --- |

Length: 150 meters

| | Width: 18 meters |
| --- | --- |

Width: 18 meters

| | LDT: 7 000 |
| --- | --- |

LDT: 7 000

Environmental limitations are defined in the prefectural authorisation.

Explicit approval – The competent authority for the approval decision is the minister of environment.

16 000  (10)

30 December 2021

| Grand Port Maritime de Bordeaux |
| --- |
| 152, Quai de Bacalan — CS 41320 - 33082 Bordeaux Cedex |
| FRANCE |

Grand Port Maritime de Bordeaux

152, Quai de Bacalan — CS 41320 - 33082 Bordeaux Cedex

FRANCE

Phone: +33 556905800

Email: maintenance@bordeaux-port.fr

Alongside, drydock

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions (drydock):

| | Length: 240 meters |
| --- | --- |

Length: 240 meters

| | Width: 37 meters |
| --- | --- |

Width: 37 meters

| | Depth: 17 meters |
| --- | --- |

Depth: 17 meters

Environmental limitations are defined in the prefectural authorisation.

Explicit approval – The competent authority for the approval decision is the minister of environment.

18 000  (11)

21 October 2021

| Les Recycleurs bretons |
| --- |
| Zone Industrielle de Kerbriant - 29 610 Plouigneau |
| FRANCE |

Les Recycleurs bretons

Zone Industrielle de Kerbriant - 29 610 Plouigneau

FRANCE

Phone: +33 298011106

Email: navaleo@navaleo.fr

Alongside, drydock

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions (drydock):

| | Length: 225 meters |
| --- | --- |

Length: 225 meters

| | Width: 34 meters |
| --- | --- |

Width: 34 meters

| | Depth: 27 meters |
| --- | --- |

Depth: 27 meters

Environmental limitations are defined in the prefectural authorisation.

Explicit approval – The competent authority for the approval decision is the minister of environment.

5 500  (12)

24 May 2021

LATVIA

| A/S ‘Tosmares kuģubūvētava’ |
| --- |
| Ģenerāļa Baloža street 42/44, Liepaja, LV-3402 |
| LATVIA |

A/S ‘Tosmares kuģubūvētava’

Ģenerāļa Baloža street 42/44, Liepaja, LV-3402

LATVIA

Phone: +371 63401919

Email: shipyard@tosmare.lv

Ship dismantling (wet berth and dry dock)

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 165 m |
| --- | --- |

Length: 165 m

| | Width: 22 m |
| --- | --- |

Width: 22 m

| | Depth: 7 m |
| --- | --- |

Depth: 7 m

| | DWT: 14 000 |
| --- | --- |

DWT: 14 000

| | GT: 200 - 12 000 |
| --- | --- |

GT: 200 - 12 000

| | Weight: 100 – 5 000 tonnes |
| --- | --- |

Weight: 100 – 5 000 tonnes

| | LDT: 100 -5 000 |
| --- | --- |

LDT: 100 -5 000

See national permit No. LI10IB0024.

Explicit approval — written notification in 30 working days

0 (13)

11 June 2020

LITHUANIA

| UAB APK |
| --- |
| Minijos 180 (berth 133A), LT 93269, Klaipėda, |
| LITHUANIA |

UAB APK

Minijos 180 (berth 133A), LT 93269, Klaipėda,

LITHUANIA

Phone: +370 46365776

Fax +370 46365776

Email: uab.apk@gmail.com

Alongside (wet berth)

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 130 meters |
| --- | --- |

Length: 130 meters

| | Width: 35 meters |
| --- | --- |

Width: 35 meters

| | Depth: 10 meters |
| --- | --- |

Depth: 10 meters

| | GT: 3 500 |
| --- | --- |

GT: 3 500

See national permit No. TL-KL.1-15/2015

Explicit approval — written notification in 30 working days

1 500  (14)

17 March 2020

| UAB Armar |
| --- |
| Minijos 180 (berths 127A, 131A), LT 93269, Klaipėda, |
| LITHUANIA |

UAB Armar

Minijos 180 (berths 127A, 131A), LT 93269, Klaipėda,

LITHUANIA

Phone: +370 68532607

Email: armar.uab@gmail.com; albatrosas33@gmail.com

Alongside (wet berth)

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions (berth 127A):

| | Length: 80 meters |
| --- | --- |

Length: 80 meters

| | Width: 16 meters |
| --- | --- |

Width: 16 meters

| | Depth: 6 meters |
| --- | --- |

Depth: 6 meters

| | GT: 1 500 |
| --- | --- |

GT: 1 500

Maximum ship dimensions (berth 131A):

| | Length: 80 meters |
| --- | --- |

Length: 80 meters

| | Width: 16 meters |
| --- | --- |

Width: 16 meters

| | Depth: 5 meters |
| --- | --- |

Depth: 5 meters

| | GT: 1 500 |
| --- | --- |

GT: 1 500

See national permit No. TL-KL.1-16/2015 (berth 127A)

See national permit No. TL-KL.1-51/2017 (berth 131A)

Explicit approval — written notification in 30 working days

3 910  (15)

17 March 2020

(berth 127A)

19 April 2022

(berth 131A)

| UAB Vakaru refonda |
| --- |
| Minijos 180 (berths 129, 130, 131A, 131, 132, 133A), LT 93269, Klaipėda, |
| LITHUANIA |

UAB Vakaru refonda

Minijos 180 (berths 129, 130, 131A, 131, 132, 133A), LT 93269, Klaipėda,

LITHUANIA

Phone: +370 46483940/483891

Fax +370 46483891

Email: refonda@wsy.lt

Alongside (wet berth)

Ships as defined in point (1) of Article 3(1) of Regulation (EU) No 1257/2013

Maximum ship dimensions:

| | Length: 230 meters |
| --- | --- |

Length: 230 meters

| | Width: 55 meters |
| --- | --- |

Width: 55 meters

| | Depth: 14 meters |
| --- | --- |

Depth: 14 meters

| | GT: 70 000 |
| --- | --- |

GT: 70 000

See national permit No. (11.2)-30-161/2011/TL-KL.1-18/2015

Explicit approval — written notification in 30 working days

20 140  (16)

21 May 2020

NETHERLANDS

| Keppel-Verolme |
| --- |
| Prof. Gerbrandyweg 25 |
| 3197 KK Rotterdam-Botlek |
| THE NETHERLANDS |

Keppel-Verolme

Prof. Gerbrandyweg 25

3197 KK Rotterdam-Botlek

THE NETHERLANDS

Phone: +31 181234353

Email: mzoethout@keppelverolme.nl

Shipbreaking

Maximum ship dimensions:

| | Length: 405 meters |
| --- | --- |

Length: 405 meters

| | Width: 90 meters |
| --- | --- |

Width: 90 meters

| | Depth: 11,6 meters |
| --- | --- |

Depth: 11,6 meters

The site has a permit to operate; this permit contains limitations and conditions to operate in an environmental sound manner.

Explicit approval

52 000  (17)

21 July 2021

| Scheepssloperij Nederland B.V. |
| --- |
| Havenweg 1; 3295 XZ s-Gravendeel |
| Postbus 5234; 3295 ZJ s-Gravendeel |
| THE NETHERLANDS |

Scheepssloperij Nederland B.V.

Havenweg 1; 3295 XZ s-Gravendeel

Postbus 5234; 3295 ZJ s-Gravendeel

THE NETHERLANDS

Phone: +31 786736055

Email: info@sloperij-nederland.nl

Shipbreaking

Maximum ship dimensions:

| | Length: 200 meters |
| --- | --- |

Length: 200 meters

| | Width: 33 meters |
| --- | --- |

Width: 33 meters

| | Depth: 6 meters |
| --- | --- |

Depth: 6 meters

| | Height: 45 meters (Botlekbridge) |
| --- | --- |

Height: 45 meters (Botlekbridge)

Recycling operations start on water to make the hull lighter; the winch to haul ships on the ramp can pull 2 000 tonnes.

The site has a permit to operate; this permit contains limitations and conditions to operate in an environmental sound manner.

Explicit approval

9 300  (18)

27 September 2021

PORTUGAL

| Navalria — Docas, Construções e Reparações Navais |
| --- |
| Porto Comercial, Terminal Sul, Apartado 39, 3811-901 Aveiro |
| PORTUGAL |

Navalria — Docas, Construções e Reparações Navais

Porto Comercial, Terminal Sul, Apartado 39, 3811-901 Aveiro

PORTUGAL

Phone: +351 234378970, +351 232767700

email: info@navalria.pt

Dry dock dismantling, decontamination and dismantling on an horizontal plane and inclined plane, according to the ship's size

Nominal capacity of the horizontal plane: 700 tonnes

Nominal capacity of the inclined plane: 900 tonnes

Conditions applied to the activity are defined in specifications annexed to Title (AL n.o 5/2015/CCDRC, of 26 January 2016

1 900 tonnes (19)

26 January 2020

UNITED KINGDOM

| Able UK Limited |
| --- |
| Teesside Environmental Reclamation and Recycling Centre |
| Graythorp Dock |
| Tees Road |
| Hartlepool |
| Cleveland |
| TS25 2DB |
| UNITED KINGDOM |

Able UK Limited

Teesside Environmental Reclamation and Recycling Centre

Graythorp Dock

Tees Road

Hartlepool

Cleveland

TS25 2DB

UNITED KINGDOM

Phone: +44 1642806080

Email: info@ableuk.com

Ship dismantling and associated treatment authorised with dry dock and wet berth

Any ship within the dimensions authorised within the permit.

Maximum ship dimensions:

| | Length: 337,5 meters |
| --- | --- |

Length: 337,5 meters

| | Beam: 120 meters |
| --- | --- |

Beam: 120 meters

| | Draft: 6,65 meters |
| --- | --- |

Draft: 6,65 meters

The facility has a Ship Recycling Facility Plan that meets the requirements of Regulation (EU) No 1257/2013.

The site is authorised by way of a permit (Reference EPR/VP3296ZM) that limits the operations and places conditions on the operator of the facility.

Explicit approval

66 340  (20)

6 October 2020

| Dales Marine Services Ltd |
| --- |
| Imperial Dry Dock |
| Leith |
| Edinburgh |
| EH6 7DR |
| UNITED KINGDOM |

Dales Marine Services Ltd

Imperial Dry Dock

Leith

Edinburgh

EH6 7DR

UNITED KINGDOM

Contact:

| | Phone: +44 1314543380 |
| --- | --- |

Phone: +44 1314543380

| | Email: leithadmin@dalesmarine.co.uk; b.robertson@dalesmarine.co.uk |
| --- | --- |

Email: leithadmin@dalesmarine.co.uk; b.robertson@dalesmarine.co.uk

Ship dismantling and associated treatment authorizsd within a drydock, and wet berth

Any ship up to a maximum of 7 000 tonnes

Maximum ship dimensions:

| | Length: 165 meters |
| --- | --- |

Length: 165 meters

| | Beam: 21 meters |
| --- | --- |

Beam: 21 meters

| | Draft: 7,7 meters |
| --- | --- |

Draft: 7,7 meters

The facility has a Ship Recycling Facility Plan that meets the requirements of Regulation (EU) No 1257/2013. The site is authorised by way of a licence (Ref: WML L 1157331) that limits the operations and places conditions on the operator of the facility.

Explicit approval

7 275  (21)

2 November 2022

| Harland and Wolff Heavy Industries Limited |
| --- |
| Queen's Island |
| Belfast |
| BT3 9DU |
| UNITED KINGDOM |

Harland and Wolff Heavy Industries Limited

Queen's Island

Belfast

BT3 9DU

UNITED KINGDOM

Phone: +44 2890458456

Email: trevor.hutchinson@harland-wolff.com

Ship dismantling and associated treatment authorised with dry dock, and wet berth

Any ship with the dimensions detailed in the agreed Working Plan.

Maximum ship dimensions:

The main dock (the largest) is 556 m × 93 m × 1,2 m DWT, and can take vessels up to this size. This largest dry dock is 1,2 million DWT.

The facility has a Ship Recycling Facility Plan that meets the requirements of Regulation (EU) No 1257/2013.

The site is authorised by way of a waste management licence, authorisation number LN/07/21/V2 that limits the operations and places conditions on the operator of the facility.

Explicit approval

13 200  (22)

3 August 2020

| Swansea Drydock Ltd |
| --- |
| Prince of Wales Dry Dock |
| Swansea |
| Wales |
| SA1 1LY |
| UNITED KINGDOM |

Swansea Drydock Ltd

Prince of Wales Dry Dock

Swansea

Wales

SA1 1LY

UNITED KINGDOM

Phone: +44 1792654592

Email: info@swanseadrydocks.com

Ship dismantling and associated treatment authorised with dry dock, and wet berth

Any ship within the dimensions authorised within the permit.

Maximum ship dimensions:

| | Length: 200 meters |
| --- | --- |

Length: 200 meters

| | Beam: 27 meters |
| --- | --- |

Beam: 27 meters

| | Draft: 7 meters |
| --- | --- |

Draft: 7 meters

Site has a Ship Recycling Facility Plan that meets with the requirements of Regulation (EU) No 1257/2013.

The site is authorised by way of a permit (Reference EPR/UP3298VL) that limits the operations and places conditions on the operator of the facility.

Explicit approval

7 275  (23)

2 July 2020

---

(1)  As referred to in Article 7(3) of Regulation (EU) No 1257/2013 on ship recycling.

(2)  As referred to in the third sentence of Article 32(1)(a) of Regulation (EU) No 1257/2013.

(3)  The date of expiry of inclusion in the European List corresponds to the date of expiry of the permit or authorisation granted to the facility in the Member State.

(4)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 50 000 LDT per year.

(5)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 50 000 LDT per year.

(6)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 50 000 LDT per year.

(7)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 15 000 LDT per year.

(8)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 60 000 LDT per year.

(9)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 15 000 LDT per year.

(10)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 18 000 LDT per year.

(11)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 23 000 LDT per year.

(12)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 10 000 LDT per year.

(13)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 15 000 LDT per year.

(14)  According to its permit, the facility is authorised to recycle a maximum 30 000 LDT per year.

(15)  According to its permits, the facility is authorised to recycle a maximum 12 000 LDT per year (6 000 LDT per berth).

(16)  According to its permit, the facility is authorised to recycle a maximum 45 000 LDT per year.

(17)  According to its permit, the theoretical maximum annual ship recycling capacity of the facility is 100 000 tonnes per year.

(18)  According to the information submitted, the theoretical maximum annual ship recycling capacity of the facility is 45 000 LDT per year.

(19)  No information on theoretical maximum annual ship recycling capacity was provided.

(20)  According to its permit, the facility is authorised to recycle a maximum of 230 000 tonnes per year.

(21)  According to its permit, the facility is authorised to recycle a maximum of 7 275 tonnes per year.

(22)  According to its permit, the facility is authorised to recycle a maximum of 300 000 tonnes per year.

(23)  According to its permit, the facility is authorised to recycle a maximum of 74 999 tonnes per year.

---

| 4.10.2018 | EN | Official Journal of the European Union | L 249/16 |
| --- | --- | --- | --- |

4.10.2018

EN

Official Journal of the European Union

L 249/16

---

COMMISSION IMPLEMENTING DECISION (EU) 2018/1479

of 3 October 2018

postponing the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8

(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 14(5) thereof,

After consulting the Standing Committee on Biocidal Products,

Whereas:

| (1) | The active substance sulfuryl fluoride was included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive. |
| --- | --- |

(1)

The active substance sulfuryl fluoride was included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products of product-type 8, and pursuant to Article 86 of Regulation (EU) No 528/2012 is therefore considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

| (2) | The approval of sulfuryl fluoride for use in biocidal products of product-type 8 will expire on 31 December 2018. In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application has been submitted for the renewal of the approval of this active substance on 28 June 2017. |
| --- | --- |

(2)

The approval of sulfuryl fluoride for use in biocidal products of product-type 8 will expire on 31 December 2018. In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application has been submitted for the renewal of the approval of this active substance on 28 June 2017.

| (3) | The evaluating competent authority of Sweden has informed the Commission services on 14 February 2018 on its decision pursuant to Article 14(2) of Regulation (EU) No 528/2012 that a full evaluation will have to be performed. A 365-day period is allowed to perform a full evaluation pursuant to Article 8(1) of that Regulation. During the evaluation, the evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances. |
| --- | --- |

(3)

The evaluating competent authority of Sweden has informed the Commission services on 14 February 2018 on its decision pursuant to Article 14(2) of Regulation (EU) No 528/2012 that a full evaluation will have to be performed. A 365-day period is allowed to perform a full evaluation pursuant to Article 8(1) of that Regulation. During the evaluation, the evaluating competent authority may, as appropriate, request the applicant to provide sufficient data to carry out the evaluation, in accordance with Article 8(2) of that Regulation. In such case, the 365-day period is suspended for a period that may not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

| (4) | Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.

| (5) | Consequently, for reasons beyond the control of the applicant, the approval of sulfuryl fluoride for use in biocidal products of product-type 8 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application. Considering the periods of time allowed for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 30 June 2021. |
| --- | --- |

(5)

Consequently, for reasons beyond the control of the applicant, the approval of sulfuryl fluoride for use in biocidal products of product-type 8 is likely to expire before a decision has been taken on its renewal. It is therefore appropriate to postpone the expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 for a period of time sufficient to enable the examination of the application. Considering the periods of time allowed for the evaluation by the evaluating competent authority and for the preparation and submission of the opinion by the Agency, it is appropriate to postpone the expiry date of approval to 30 June 2021.

| (6) | Except for the expiry date of the approval, sulfuryl fluoride should remain approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC, |
| --- | --- |

(6)

Except for the expiry date of the approval, sulfuryl fluoride should remain approved for use in biocidal products of product-type 8 subject to the specifications and conditions set out in Annex I to Directive 98/8/EC,

HAS ADOPTED THIS DECISION:

Article 1

The expiry date of approval of sulfuryl fluoride for use in biocidal products of product-type 8 is postponed to 30 June 2021.

Article 2

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

Done at Brussels, 3 October 2018.

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

---

Corrigenda

| 4.10.2018 | EN | Official Journal of the European Union | L 249/18 |
| --- | --- | --- | --- |

4.10.2018

EN

Official Journal of the European Union

L 249/18

---

Corrigendum to Commission Regulation (EU) 2017/227 of 9 February 2017 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(pentabromophenyl)ether

(
  Official Journal of the European Union L 35 of 10 February 2017
  )

On page 9, the Annex is replaced as follows:

‘ANNEX

In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:

| ‘67. | Bis(pentabromophenyl)ether
  (decabromodiphenyl ether; decaBDE)
  CAS No 1163-19-5
  EC No 214-604-9 |
| --- | --- |

‘67.

Bis(pentabromophenyl)ether

(decabromodiphenyl ether; decaBDE)

CAS No 1163-19-5

EC No 214-604-9

| 1. | Shall not be manufactured or placed on the market as a substance on its own after 2 March 2019. |
| --- | --- |

1.

Shall not be manufactured or placed on the market as a substance on its own after 2 March 2019.

| 2. | Shall not be used in the production of, or placed on the market in:






  (a) | another substance, as a constituent; |
| --- | --- | --- |

2.

Shall not be used in the production of, or placed on the market in:

(a)

another substance, as a constituent;

| (b) | a mixture; |
| --- | --- |

(b)

a mixture;

| (c) | an article, or any part thereof, |
| --- | --- |

(c)

an article, or any part thereof,

in a concentration equal to or greater than 0,1 % by weight, after 2 March 2019.

| 3. | Paragraphs 1 and 2 shall not apply to a substance, constituent of another substance or mixture that is to be used, or is used:






  (a) | in the production of an aircraft before 2 March 2027. |
| --- | --- | --- |

3.

Paragraphs 1 and 2 shall not apply to a substance, constituent of another substance or mixture that is to be used, or is used:

(a)

in the production of an aircraft before 2 March 2027.

| (b) | in the production of spare parts for either of the following:






  (i) | an aircraft produced before 2 March 2027; |
| --- | --- | --- |

(b)

in the production of spare parts for either of the following:

(i)

an aircraft produced before 2 March 2027;

| (ii) | motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council (*1) or machinery within the scope of Directive 2006/42/EC of the European Parliament and of the Council (*2), produced before 2 March 2019. |
| --- | --- |

(ii)

motor vehicles within the scope of Directive 2007/46/EC, agricultural and forestry vehicles within the scope of Regulation (EU) No 167/2013 of the European Parliament and of the Council (*1) or machinery within the scope of Directive 2006/42/EC of the European Parliament and of the Council (*2), produced before 2 March 2019.

| 4. | Subparagraph 2(c) shall not apply to any of the following:






  (a) | articles placed on the market before 2 March 2019; |
| --- | --- | --- |

4.

Subparagraph 2(c) shall not apply to any of the following:

(a)

articles placed on the market before 2 March 2019;

| (b) | aircraft produced in accordance with subparagraph 3(a); |
| --- | --- |

(b)

aircraft produced in accordance with subparagraph 3(a);

| (c) | spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 3(b); |
| --- | --- |

(c)

spare parts of aircraft, vehicles or machines produced in accordance with subparagraph 3(b);

| (d) | electrical and electronic equipment within the scope of Directive 2011/65/EU. |
| --- | --- |

(d)

electrical and electronic equipment within the scope of Directive 2011/65/EU.

| 5. | For the purposes of this entry ‘aircraft’ means one of the following:






  (a) | a civil aircraft produced in accordance with a type certificate issued under Regulation (EU) No 216/2008 of the European Parliament and of the Council (*3) or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation; |
| --- | --- | --- |

5.

For the purposes of this entry ‘aircraft’ means one of the following:

(a)

a civil aircraft produced in accordance with a type certificate issued under Regulation (EU) No 216/2008 of the European Parliament and of the Council (*3) or with a design approval issued under the national regulations of a contracting State of the International Civil Aviation Organisation (ICAO), or for which a certificate of airworthiness has been issued by an ICAO contracting State under Annex 8 to the Convention on International Civil Aviation;

| (b) | a military aircraft. |
| --- | --- |

(b)

a military aircraft.

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(*1)  Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the approval and market surveillance of agricultural and forestry vehicles (OL L 60, 2.3.2013, p. 1).

*1

(*2)  Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

*2

(*3)  Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).’

*3

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