# Official Journal L 50/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 50 |
| | |
| English edition | Legislation | Volume 6617 February 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 50

English edition

Legislation

Volume 6617 February 2023

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2023/362 of 14 February 2023 on the signing, on behalf of the Union, of the Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services | 1 |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2023/363 of 31 October 2022 amending and correcting the regulatory technical standards laid down in Delegated Regulation (EU) 2022/1288 as regards the content and presentation of information in relation to disclosures in pre-contractual documents and periodic reports for financial products investing in environmentally sustainable economic activities (
  1
  ) | 3 |
| | * | Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family IPA Family 1 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 28 |
| | * | Commission Implementing Regulation (EU) 2023/365 of 16 February 2023 terminating the expiry review investigation concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Ukraine | 56 |
| | * | Commission Implementing Regulation (EU) 2023/366 of 16 February 2023 concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.) (
  1
  ) | 59 |
| | | DECISIONS |
| | * | Decision (EU) 2023/367 of the European Parliament of 19 January 2023 extending the term of office of the Committee of Inquiry to investigate the use of the Pegasus and equivalent surveillance spyware | 65 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2023/362 of 14 February 2023 on the signing, on behalf of the Union, of the Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services

1

REGULATIONS

*

Commission Delegated Regulation (EU) 2023/363 of 31 October 2022 amending and correcting the regulatory technical standards laid down in Delegated Regulation (EU) 2022/1288 as regards the content and presentation of information in relation to disclosures in pre-contractual documents and periodic reports for financial products investing in environmentally sustainable economic activities (
  1
  )

1

3

*

Commission Implementing Regulation (EU) 2023/364 of 16 February 2023 granting a Union authorisation for the biocidal product family IPA Family 1 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

28

*

Commission Implementing Regulation (EU) 2023/365 of 16 February 2023 terminating the expiry review investigation concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Ukraine

56

*

Commission Implementing Regulation (EU) 2023/366 of 16 February 2023 concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.) (
  1
  )

Bacillus velezensis

1

59

DECISIONS

*

Decision (EU) 2023/367 of the European Parliament of 19 January 2023 extending the term of office of the Committee of Inquiry to investigate the use of the Pegasus and equivalent surveillance spyware

65

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

| 17.2.2023 | EN | Official Journal of the European Union | L 50/1 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/1

---

COUNCIL DECISION (EU) 2023/362

of 14 February 2023

on the signing, on behalf of the Union, of the Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | On 5 June 2003, the Council authorised the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with an agreement at Union level. |
| --- | --- |

(1)

On 5 June 2003, the Council authorised the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with an agreement at Union level.

| (2) | The Commission has negotiated, on behalf of the Union, an Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services (‘the Agreement’). The negotiations were successfully concluded by the initialling of the Agreement on 21 September 2022. |
| --- | --- |

(2)

The Commission has negotiated, on behalf of the Union, an Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services (‘the Agreement’). The negotiations were successfully concluded by the initialling of the Agreement on 21 September 2022.

| (3) | The objective of the Agreement is to bring bilateral air services agreements between 13 Member States and Japan in line with Union law. |
| --- | --- |

(3)

The objective of the Agreement is to bring bilateral air services agreements between 13 Member States and Japan in line with Union law.

| (4) | The Agreement should be signed on behalf of the Union, subject to its conclusion at a later date, |
| --- | --- |

(4)

The Agreement should be signed on behalf of the Union, subject to its conclusion at a later date,

HAS ADOPTED THIS DECISION:

Article 1

The signing on behalf of the Union of the Agreement between the European Union and Japan on certain provisions of agreements between Member States of the European Union and Japan for air services (‘the Agreement’) is hereby authorised, subject to the conclusion of the said Agreement (1).

Article 2

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

Article 3

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

Done at Brussels, 14 February 2023.

For the Council

The President

E. SVANTESSON

---

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

1

---

REGULATIONS

| 17.2.2023 | EN | Official Journal of the European Union | L 50/3 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/3

---

COMMISSION DELEGATED REGULATION (EU) 2023/363

of 31 October 2022

amending and correcting the regulatory technical standards laid down in Delegated Regulation (EU) 2022/1288 as regards the content and presentation of information in relation to disclosures in pre-contractual documents and periodic reports for financial products investing in environmentally sustainable economic activities

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2019/2088 of the European Parliament and of the Council of 27 November 2019 on sustainability-related disclosures in the financial services sector (1), and in particular Article 8(3), fourth subparagraph, Article 8(4), fourth subparagraph, Article 9(5), fourth subparagraph, Article 9(6), fourth subparagraph, Article 10(2), fourth subparagraph, Article 11(4), fourth subparagraph and Article 11(5), fourth subparagraph thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2022/1288 (2) lays down the details of the content and presentation of the information in relation to the principle of ‘do no significant harm’. It also specifies the content, methodologies and presentation of information in relation to sustainability indicators and adverse sustainability impacts and the content and presentation of the information to be provided in pre-contractual documents, on website and in periodic reports, in relation to the promotion of environmental or social characteristics and sustainable investment objectives of financial products. Moreover, with regard to the financial products investing in an economic activity that contributes to an environmental objective within the meaning of Article 2, point (17), of Regulation (EU) 2019/2088, Delegated Regulation (EU) 2022/1288 also specifies the information on the degree of taxonomy-alignment to be disclosed within pre-contractual documents and periodic reports. |
| --- | --- |

(1)

Commission Delegated Regulation (EU) 2022/1288 (2) lays down the details of the content and presentation of the information in relation to the principle of ‘do no significant harm’. It also specifies the content, methodologies and presentation of information in relation to sustainability indicators and adverse sustainability impacts and the content and presentation of the information to be provided in pre-contractual documents, on website and in periodic reports, in relation to the promotion of environmental or social characteristics and sustainable investment objectives of financial products. Moreover, with regard to the financial products investing in an economic activity that contributes to an environmental objective within the meaning of Article 2, point (17), of Regulation (EU) 2019/2088, Delegated Regulation (EU) 2022/1288 also specifies the information on the degree of taxonomy-alignment to be disclosed within pre-contractual documents and periodic reports.

| (2) | Commission Delegated Regulation (EU) 2022/1214 (3), with particular reference to fossil gas and nuclear energy sectors was adopted on 9 March 2022. |
| --- | --- |

(2)

Commission Delegated Regulation (EU) 2022/1214 (3), with particular reference to fossil gas and nuclear energy sectors was adopted on 9 March 2022.

| (3) | The Commission invited the European Supervisory Authorities to jointly propose amendments to Delegated Regulation (EU) 2022/1288 in relation to the information to be provided in pre-contractual documents, on websites, and in periodic reports about the exposure of financial products to investments in fossil gas and nuclear energy activities. |
| --- | --- |

(3)

The Commission invited the European Supervisory Authorities to jointly propose amendments to Delegated Regulation (EU) 2022/1288 in relation to the information to be provided in pre-contractual documents, on websites, and in periodic reports about the exposure of financial products to investments in fossil gas and nuclear energy activities.

| (4) | Those amendments are necessary to increase transparency and thereby to help financial markets participants and investors to identify environmentally sustainable fossil gas and nuclear related activities invested in by financial products. The provision of the more detailed information on investments in those activities should also foster comparability of the information disclosed to investors. Therefore, it is appropriate to provide transparency on investments in environmentally sustainable fossil gas and nuclear energy activities over the whole life of the relevant financial products, in pre-contractual documents and in periodic reports. Such information should also be included in the website disclosures. The European Supervisory Authorities noted that transparency about investments in sectors and sub-sectors related to fossil gas and nuclear energy activities is already required as part of the provisions for periodic reports under Delegated Regulation (EU) 2022/1288. |
| --- | --- |

(4)

Those amendments are necessary to increase transparency and thereby to help financial markets participants and investors to identify environmentally sustainable fossil gas and nuclear related activities invested in by financial products. The provision of the more detailed information on investments in those activities should also foster comparability of the information disclosed to investors. Therefore, it is appropriate to provide transparency on investments in environmentally sustainable fossil gas and nuclear energy activities over the whole life of the relevant financial products, in pre-contractual documents and in periodic reports. Such information should also be included in the website disclosures. The European Supervisory Authorities noted that transparency about investments in sectors and sub-sectors related to fossil gas and nuclear energy activities is already required as part of the provisions for periodic reports under Delegated Regulation (EU) 2022/1288.

| (5) | It is necessary to clarify that to trigger the application of Article 6 of Regulation (EU) 2020/852 of the European Parliament and of the Council (4), it is irrelevant if a financial product commits to invest in economic activities that contribute to an environmental objective within the meaning of Article 2, point (17), of Regulation (EU) 2019/2088. |
| --- | --- |

(5)

It is necessary to clarify that to trigger the application of Article 6 of Regulation (EU) 2020/852 of the European Parliament and of the Council (4), it is irrelevant if a financial product commits to invest in economic activities that contribute to an environmental objective within the meaning of Article 2, point (17), of Regulation (EU) 2019/2088.

| (6) | In addition, European Supervisory Authorities noted that two changes were required to the cross-references in the periodic disclosures given that these were erroneous. |
| --- | --- |

(6)

In addition, European Supervisory Authorities noted that two changes were required to the cross-references in the periodic disclosures given that these were erroneous.

| (7) | Delegated Regulation (EU) 2022/1288 should therefore be amended and corrected accordingly. |
| --- | --- |

(7)

Delegated Regulation (EU) 2022/1288 should therefore be amended and corrected accordingly.

| (8) | This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority, the European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority (European Supervisory Authorities). |
| --- | --- |

(8)

This Regulation is based on the draft regulatory technical standards submitted to the Commission by the European Banking Authority, the European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority (European Supervisory Authorities).

| (9) | The Joint Committee of the European Supervisory Authorities referred to in Article 54 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (5), in Article 54 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (6) and in Article 54 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7) has requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010, the Insurance and Reinsurance Stakeholder Group and the Occupational Pensions Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1094/2010, and the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010. |
| --- | --- |

(9)

The Joint Committee of the European Supervisory Authorities referred to in Article 54 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (5), in Article 54 of Regulation (EU) No 1094/2010 of the European Parliament and of the Council (6) and in Article 54 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7) has requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010, the Insurance and Reinsurance Stakeholder Group and the Occupational Pensions Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1094/2010, and the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010.

| (10) | The amendments to Delegated Regulation (EU) 2022/1288 are limited adjustments of the existing regulatory framework and are necessary to align the disclosure framework to Delegated Regulation (EU) 2022/1214, which is to apply from 1 January 2023. Given the limited scope of the amendments and the need to ensure legal certainty and coherence with the application of Delegated Regulations (EU) 2022/1214 and (EU) 2022/1288, it would have been disproportionate for the European Supervisory Authorities to conduct open public consultations or analyses of the potential related costs and benefits, |
| --- | --- |

(10)

The amendments to Delegated Regulation (EU) 2022/1288 are limited adjustments of the existing regulatory framework and are necessary to align the disclosure framework to Delegated Regulation (EU) 2022/1214, which is to apply from 1 January 2023. Given the limited scope of the amendments and the need to ensure legal certainty and coherence with the application of Delegated Regulations (EU) 2022/1214 and (EU) 2022/1288, it would have been disproportionate for the European Supervisory Authorities to conduct open public consultations or analyses of the potential related costs and benefits,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Delegated Regulation (EU) 2022/1288

Delegated Regulation (EU) 2022/1288 is amended as follows:

| (1) | in Article 15, paragraph 2 is replaced by the following:

  ‘2.   For the purposes of paragraph 1, point (a), all of the following shall apply:






  (a) | financial market participants shall use:






  (i) | the same key performance indicator for the aggregated investments in non-financial undertakings; |
| --- | --- | --- | --- |

(1)

in Article 15, paragraph 2 is replaced by the following:

‘2.   For the purposes of paragraph 1, point (a), all of the following shall apply:

(a)

financial market participants shall use:

(i)

the same key performance indicator for the aggregated investments in non-financial undertakings;

| (ii) | the same key performance indicator for the aggregated investments in the same type of financial undertakings; |
| --- | --- |

(ii)

the same key performance indicator for the aggregated investments in the same type of financial undertakings;

| (b) | for insurance and reinsurance undertakings that carry out non-life underwriting activities, the key performance indicator may combine the investment and the underwriting key performance indicators in accordance with Article 6 of Delegated Regulation (EU) 2021/2178; |
| --- | --- |

(b)

for insurance and reinsurance undertakings that carry out non-life underwriting activities, the key performance indicator may combine the investment and the underwriting key performance indicators in accordance with Article 6 of Delegated Regulation (EU) 2021/2178;

| (c) | where the financial products invest in environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of Annexes I and II to Delegated Regulation (EU) 2021/2139, or in environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes, the graphical representations shall illustrate separately the proportion of the aggregated investments in:






  (i) | environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of those Annexes; |
| --- | --- | --- |

(c)

where the financial products invest in environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of Annexes I and II to Delegated Regulation (EU) 2021/2139, or in environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes, the graphical representations shall illustrate separately the proportion of the aggregated investments in:

(i)

environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of those Annexes;

| (ii) | environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes.’ |
| --- | --- |

(ii)

environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes.’

| (2) | Article 55 is amended as follows:






  (a) | in paragraph 1, the introductory sentence is replaced by the following:

  ‘For financial products referred to in Article 6, first paragraph, of Regulation (EU) 2020/852, financial market participants shall include in the section ‘What was the proportion of sustainability-related investments?’ in the template set out in Annex IV all of the following information:’; |
| --- | --- | --- |

(2)

Article 55 is amended as follows:

(a)

in paragraph 1, the introductory sentence is replaced by the following:

‘For financial products referred to in Article 6, first paragraph, of Regulation (EU) 2020/852, financial market participants shall include in the section ‘What was the proportion of sustainability-related investments?’ in the template set out in Annex IV all of the following information:’;

| (b) | in paragraph 2, the following point (d) is added:






  ‘(d) | where the financial products made investments during the period covered by the periodic report in environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of Annexes I and II to Delegated Regulation (EU) 2021/2139 or in environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes, a graphical representation shall illustrate separately:






  (i) | the aggregate of the environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of those Annexes; |
| --- | --- | --- | --- |

(b)

in paragraph 2, the following point (d) is added:

‘(d)

where the financial products made investments during the period covered by the periodic report in environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of Annexes I and II to Delegated Regulation (EU) 2021/2139 or in environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes, a graphical representation shall illustrate separately:

(i)

the aggregate of the environmentally sustainable economic activities referred to in Sections 4.26, 4.27 and 4.28 of those Annexes;

| (ii) | the aggregate of the environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes.’; |
| --- | --- |

(ii)

the aggregate of the environmentally sustainable economic activities referred to in Sections 4.29, 4.30 and 4.31 of those Annexes.’;

| (3) | Annexes II to V are replaced by Annexes I to IV to this Regulation. |
| --- | --- |

(3)

Annexes II to V are replaced by Annexes I to IV to this Regulation.

Article 2

Corrections to Delegated Regulation (EU) 2022/1288

Delegated Regulation (EU) 2022/1288 is corrected as follows:

| (1) | in Article 55(1), in point (b), point (iv) is replaced by the following:






  ‘(iv) | the information referred to in Article 15(3), point (b);’; |
| --- | --- | --- |

(1)

in Article 55(1), in point (b), point (iv) is replaced by the following:

‘(iv)

the information referred to in Article 15(3), point (b);’;

| (2) | in Article 62(1), in point (b), point (iv) is replaced by the following:






  ‘(iv) | the information referred to in Article 15(3), point (b);’. |
| --- | --- | --- |

(2)

in Article 62(1), in point (b), point (iv) is replaced by the following:

‘(iv)

the information referred to in Article 15(3), point (b);’.

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 31 October 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 317, 9.12.2019, p. 1.

1

(2)  Commission Delegated Regulation (EU) 2022/1288 of 6 April 2022 supplementing Regulation (EU) 2019/2088 of the European Parliament and of the Council with regard to regulatory technical standards specifying the details of the content and presentation of the information in relation to the principle of ‘do no significant harm’, specifying the content, methodologies and presentation of information in relation to sustainability indicators and adverse sustainability impacts, and the content and presentation of the information in relation to the promotion of environmental or social characteristics and sustainable investment objectives in pre-contractual documents, on websites and in periodic reports (OJ L 196, 25.7.2022, p. 1).

2

(3)  Commission Delegated Regulation (EU) 2022/1214 of 9 March 2022 amending Delegated Regulation (EU) 2021/2139 as regards economic activities in certain energy sectors and Delegated Regulation (EU) 2021/2178 as regards specific public disclosures for those economic activities (OJ L 188, 15.7.2022, p. 1).

3

(4)  Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).

4

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

5

(6)  Regulation (EU) No 1094/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Insurance and Occupational Pensions Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/79/EC (OJ L 331, 15.12.2010, p. 48).

6

(7)  Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/77/EC (OJ L 331, 15.12.2010, p. 84).

7

---

ANNEX I

‘ANNEX II

Template pre-contractual disclosure for the financial products referred to in Article 8, paragraphs 1, 2 and 2a, of Regulation (EU) 2019/2088 and Article 6, first paragraph, of Regulation (EU) 2020/852

Image 1

Image 2

Image 3

Image 4

Image 5

---

ANNEX II

‘ANNEX III

Template pre-contractual disclosure for the financial products referred to in Article 9, paragraphs 1 to 4a, of Regulation (EU) 2019/2088 and Article 5, first paragraph, of Regulation (EU) 2020/852

Image 6

Image 7

Image 8

Image 9

Image 10

---

ANNEX III

‘ANNEX IV

Template periodic disclosure for the financial products referred to in Article 8, paragraphs 1, 2 and 2a, of Regulation (EU) 2019/2088 and Article 6, first paragraph, of Regulation (EU) 2020/852

Image 11

Image 12

Image 13

Image 14

Image 15

Image 16

---

ANNEX IV

‘ANNEX V

Template periodic disclosure for the financial products referred to in Article 9, paragraphs 1 to 4a, of Regulation (EU) 2019/2088 and Article 5, first paragraph, of Regulation (EU) 2020/852

Image 17

Image 18

Image 19

Image 20

Image 21

---

| 17.2.2023 | EN | Official Journal of the European Union | L 50/28 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/28

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/364

of 16 February 2023

granting a Union authorisation for the biocidal product family ‘IPA Family 1’ in accordance with Regulation (EU) No 528/2012 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 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 44(5), first subparagraph, thereof,

Whereas:

| (1) | On 10 June 2016, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘IPA Family 1’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HN024859-20 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 10 June 2016, Ecolab Deutschland GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘IPA Family 1’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HN024859-20 in the Register for Biocidal Products.

| (2) | ‘IPA Family 1’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4. |
| --- | --- |

(2)

‘IPA Family 1’ contains propan-2-ol as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

| (3) | On 25 August 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 25 August 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘IPA Family 1’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘IPA Family 1’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘IPA Family 1’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘IPA Family 1’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 12 April 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 12 April 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘IPA Family 1’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘IPA Family 1’.

| (8) | In its opinion, the Agency recommends that the authorisation holder conducts a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product is to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of that product both prior to and after storage to confirm a shelf life of 24 months. The authorisation holder should include in the test report information about the packaging stability, the spray characteristics and internal pressure before and after storage. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘IPA Family 1’ pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on the existing data. |
| --- | --- |

(8)

In its opinion, the Agency recommends that the authorisation holder conducts a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product is to be made available on the market, as a condition in the authorisation. The test should address the relevant physical, chemical and technical properties of that product both prior to and after storage to confirm a shelf life of 24 months. The authorisation holder should include in the test report information about the packaging stability, the spray characteristics and internal pressure before and after storage. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘IPA Family 1’ pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on the existing data.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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

A Union authorisation with authorisation number EU-0028425-0000 is hereby granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘IPA Family 1’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 9 March 2023 to 28 February 2033.

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 February 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  ECHA opinion of 1 March 2022 on the Union authorisation of “IPA Family 1” (ECHA/BPC/316/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

2

---

ANNEX I

Terms and conditions (EU-0028425-0000)

The authorisation holder shall conduct a long-term ambient storage stability test of ‘Klercide 70/30 IPA Aerosol’ of meta-SPC 1.3 in the commercial packaging in which the product will be made available on the market. The long-term ambient storage stability test shall address the relevant physical, chemical and technical properties of that product both prior to and after storage in accordance with section 2.6.4 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) (1), in order to confirm a shelf life of 24 months. The authorisation holder shall include in the study report information about the packaging stability, the spray characteristics and internal pressure before and after storage.

By 9 January 2024 the authorisation holder shall submit the results of the study to the Agency.

---

(1)  https://echa.europa.eu/documents/10162/23036412/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b

---

ANNEX II

Summary of product characteristics for a biocidal product family

IPA Family 1

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0028425-0000

R4BP asset number: EU-0028425-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | IPA Family 1 |
| --- | --- |

Name

IPA Family 1

1.2.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Ecolab Deutschland GmbH |
| --- | --- | --- |
| Address | Ecolab Allee 1, 40789 Monheim am Rhein Germany |
| Authorisation number | EU-0028425-0000 |
| R4BP asset number | EU-0028425-0000 |
| Date of the authorisation | 9 March 2023 |
| Expiry date of the authorisation | 28 February 2033 |

Name and address of the authorisation holder

Name

Ecolab Deutschland GmbH

Address

Ecolab Allee 1, 40789 Monheim am Rhein Germany

Authorisation number

EU-0028425-0000

R4BP asset number

EU-0028425-0000

Date of the authorisation

9 March 2023

Expiry date of the authorisation

28 February 2033

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Ecolab Europe GmbH |
| --- | --- |
| Address of manufacturer | Richtistrasse, 7, 8304 Walliselen Switzerland |
| Location of manufacturing sites | Richtistrasse, 7, 8304 Walliselen Switzerland |

Name of manufacturer

Ecolab Europe GmbH

Address of manufacturer

Richtistrasse, 7, 8304 Walliselen Switzerland

Location of manufacturing sites

Richtistrasse, 7, 8304 Walliselen Switzerland

| Name of manufacturer | Ecolab Limited |
| --- | --- |
| Address of manufacturer | Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom |
| Location of manufacturing sites | Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom |

Name of manufacturer

Ecolab Limited

Address of manufacturer

Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom

Location of manufacturing sites

Brunel Way, Baglan Energy Park, SA11 2GA Neath United Kingdom

| Name of manufacturer | Laboratoires Prodene Klint |
| --- | --- |
| Address of manufacturer | Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France |
| Location of manufacturing sites | Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France |

Name of manufacturer

Laboratoires Prodene Klint

Address of manufacturer

Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France

Location of manufacturing sites

Rue Denis Papin, 2 Z.I. Mitry Compans, F-77290 Mitry Mory France

| Name of manufacturer | Ecolab Leeds |
| --- | --- |
| Address of manufacturer | Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom |
| Location of manufacturing sites | Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom |

Name of manufacturer

Ecolab Leeds

Address of manufacturer

Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom

Location of manufacturing sites

Lotherton Way, Garforth, LS25 2JY Leeds United Kingdom

| Name of manufacturer | Esoform S.p.A. |
| --- | --- |
| Address of manufacturer | Viale del Lavoro 10, 45100 Rovigo Italy |
| Location of manufacturing sites | Viale del Lavoro 10, 45100 Rovigo Italy |

Name of manufacturer

Esoform S.p.A.

Address of manufacturer

Viale del Lavoro 10, 45100 Rovigo Italy

Location of manufacturing sites

Viale del Lavoro 10, 45100 Rovigo Italy

| Name of manufacturer | Nalco Deutschland Manufacturing GmbH und Co.KG |
| --- | --- |
| Address of manufacturer | Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany |
| Location of manufacturing sites | Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany |

Name of manufacturer

Nalco Deutschland Manufacturing GmbH und Co.KG

Address of manufacturer

Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany

Location of manufacturing sites

Justus-von-Liebig-Str. 11, D-64584 Biebesheim Germany

| Name of manufacturer | Ecolab NETHERLANDS BV |
| --- | --- |
| Address of manufacturer | Brugwal 11, 3432NZ Nieuwegein Netherlands |
| Location of manufacturing sites | Brugwal 11, 3432NZ Nieuwegein Netherlands |

Name of manufacturer

Ecolab NETHERLANDS BV

Address of manufacturer

Brugwal 11, 3432NZ Nieuwegein Netherlands

Location of manufacturing sites

Brugwal 11, 3432NZ Nieuwegein Netherlands

| Name of manufacturer | Ecolab Weavergate |
| --- | --- |
| Address of manufacturer | Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom |
| Location of manufacturing sites | Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom |

Name of manufacturer

Ecolab Weavergate

Address of manufacturer

Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom

Location of manufacturing sites

Winnington Avenue, CW8 3AA Northwich Cheshire United Kingdom

| Name of manufacturer | Ecolab Mullingar, Ireland |
| --- | --- |
| Address of manufacturer | Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland |
| Location of manufacturing sites | Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland |

Name of manufacturer

Ecolab Mullingar, Ireland

Address of manufacturer

Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland

Location of manufacturing sites

Forest Park, Zone C Mullingar Ind. Estate, – Mullingar, Co. Westmeath, Ireland

| Name of manufacturer | Ecolab d.o.o. |
| --- | --- |
| Address of manufacturer | Vajngerlova 4, 2000 Maribor Slovenia |
| Location of manufacturing sites | Vajngerlova 4, 2000 Maribor Slovenia |

Name of manufacturer

Ecolab d.o.o.

Address of manufacturer

Vajngerlova 4, 2000 Maribor Slovenia

Location of manufacturing sites

Vajngerlova 4, 2000 Maribor Slovenia

| Name of manufacturer | Ecolab Rozzano, Italy |
| --- | --- |
| Address of manufacturer | Via A. Grandi 9/11, 20089 Rozzano (MI) Italy |
| Location of manufacturing sites | Via A. Grandi 9/11, 20089 Rozzano (MI) Italy |

Name of manufacturer

Ecolab Rozzano, Italy

Address of manufacturer

Via A. Grandi 9/11, 20089 Rozzano (MI) Italy

Location of manufacturing sites

Via A. Grandi 9/11, 20089 Rozzano (MI) Italy

| Name of manufacturer | Ecolab B.V.B.A |
| --- | --- |
| Address of manufacturer | Havenlaan 4, 3980 Tessenderlo Belgium |
| Location of manufacturing sites | Havenlaan 4, 3980 Tessenderlo Belgium |

Name of manufacturer

Ecolab B.V.B.A

Address of manufacturer

Havenlaan 4, 3980 Tessenderlo Belgium

Location of manufacturing sites

Havenlaan 4, 3980 Tessenderlo Belgium

| Name of manufacturer | Nalco Española Manufacturing, SLU |
| --- | --- |
| Address of manufacturer | C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain |
| Location of manufacturing sites | C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain |

Name of manufacturer

Nalco Española Manufacturing, SLU

Address of manufacturer

C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain

Location of manufacturing sites

C/Tramuntana s/n Polígono Industrial de Celrà, 17460 Celrà Spain

| Name of manufacturer | Ecolab production France SAS |
| --- | --- |
| Address of manufacturer | BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France |
| Location of manufacturing sites | BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France |

Name of manufacturer

Ecolab production France SAS

Address of manufacturer

BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France

Location of manufacturing sites

BP509, Avenue de Général Patton, 51006 Châlons-en-Champagne France

| Name of manufacturer | Ecolab Mandra, Greece |
| --- | --- |
| Address of manufacturer | 25km Old National Road Athens- Theve, – Mandra Attica Greece |
| Location of manufacturing sites | 25km Old National Road Athens- Theve, – Mandra Attica Greece |

Name of manufacturer

Ecolab Mandra, Greece

Address of manufacturer

25km Old National Road Athens- Theve, – Mandra Attica Greece

Location of manufacturing sites

25km Old National Road Athens- Theve, – Mandra Attica Greece

| Name of manufacturer | NALCO FINLAND MANUFACTURING OY |
| --- | --- |
| Address of manufacturer | Kivikummuntie 1, FIN-07955 Tesjoki Finland |
| Location of manufacturing sites | Kivikummuntie 1, FIN-07955 Tesjoki Finland |

Name of manufacturer

NALCO FINLAND MANUFACTURING OY

Address of manufacturer

Kivikummuntie 1, FIN-07955 Tesjoki Finland

Location of manufacturing sites

Kivikummuntie 1, FIN-07955 Tesjoki Finland

| Name of manufacturer | Manufacturing Plant Cisterna Nalco |
| --- | --- |
| Address of manufacturer | Via Ninfina II, 4012 Cisterna Di Latina, Italy |
| Location of manufacturing sites | Via Ninfina II, 4012 Cisterna Di Latina Italy |

Name of manufacturer

Manufacturing Plant Cisterna Nalco

Address of manufacturer

Via Ninfina II, 4012 Cisterna Di Latina, Italy

Location of manufacturing sites

Via Ninfina II, 4012 Cisterna Di Latina Italy

| Name of manufacturer | Manufacturing Plant Fawley Nalco |
| --- | --- |
| Address of manufacturer | One business center 1180, SO45 3NP Hardley Hants United Kingdom |
| Location of manufacturing sites | One business center 1180, SO45 3NP Hardley Hants United Kingdom |

Name of manufacturer

Manufacturing Plant Fawley Nalco

Address of manufacturer

One business center 1180, SO45 3NP Hardley Hants United Kingdom

Location of manufacturing sites

One business center 1180, SO45 3NP Hardley Hants United Kingdom

| Name of manufacturer | Nalco Champion Plant, Tooling Plant, Aberdeen Nalco |
| --- | --- |
| Address of manufacturer | Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom |
| Location of manufacturing sites | Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom |

Name of manufacturer

Nalco Champion Plant, Tooling Plant, Aberdeen Nalco

Address of manufacturer

Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom

Location of manufacturing sites

Minto Avenue, Alten Industrial Estate, AB12 3JZ Aberdeen United Kingdom

| Name of manufacturer | Microtek Medical B.V. |
| --- | --- |
| Address of manufacturer | Hekkehorst, 24, 7207 BN Zutphen Netherlands |
| Location of manufacturing sites | Hekkehorst, 24, 7207 BN Zutphen Netherlands |

Name of manufacturer

Microtek Medical B.V.

Address of manufacturer

Hekkehorst, 24, 7207 BN Zutphen Netherlands

Location of manufacturing sites

Hekkehorst, 24, 7207 BN Zutphen Netherlands

| Name of manufacturer | Microtek Medical Malta Ltd. |
| --- | --- |
| Address of manufacturer | Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta |
| Location of manufacturing sites | Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta |

Name of manufacturer

Microtek Medical Malta Ltd.

Address of manufacturer

Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta

Location of manufacturing sites

Sorbonne Centre F20 Mosta Technopark, MST 3000 Mosta Malta

| Name of manufacturer | Innovate GmbH |
| --- | --- |
| Address of manufacturer | Am Hohen Stein, 11, 06618 Naumburg Germany |
| Location of manufacturing sites | Am Hohen Stein, 11, 06618 Naumburg Germany |

Name of manufacturer

Innovate GmbH

Address of manufacturer

Am Hohen Stein, 11, 06618 Naumburg Germany

Location of manufacturing sites

Am Hohen Stein, 11, 06618 Naumburg Germany

| Name of manufacturer | CHRISTEYNS FRANCE S.A. |
| --- | --- |
| Address of manufacturer | 31 rue de la Maladrie, 44120 Vertou France |
| Location of manufacturing sites | 54 avenue de la Plaine – ZI, 13106 Rousset France |

Name of manufacturer

CHRISTEYNS FRANCE S.A.

Address of manufacturer

31 rue de la Maladrie, 44120 Vertou France

Location of manufacturing sites

54 avenue de la Plaine – ZI, 13106 Rousset France

| Name of manufacturer | Techtex |
| --- | --- |
| Address of manufacturer | Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom |
| Location of manufacturing sites | Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom |

Name of manufacturer

Techtex

Address of manufacturer

Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom

Location of manufacturing sites

Units 7 & 8, Rhodes Business Park, Silbum Way, M24 4NE Middelton, Manchester United Kingdom

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Ineos Solvents Germany GmbH |
| Address of manufacturer | Römerstrasse 733, 47443 Moers Germany |
| Location of manufacturing sites | Shamrockstrasse 88, D-44623 Herne Germany
  Romestrasse, 733, D-47443, D-47443 Moers Germany |

Active substance

Propan-2-ol

Name of manufacturer

Ineos Solvents Germany GmbH

Address of manufacturer

Römerstrasse 733, 47443 Moers Germany

Location of manufacturing sites

Shamrockstrasse 88, D-44623 Herne Germany

Romestrasse, 733, D-47443, D-47443 Moers Germany

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Chemicals Europe B.V. |
| Address of manufacturer | Postbus 2334, 3000 CH Rotterdam Netherlands |
| Location of manufacturing sites | Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis, Netherlands |

Active substance

Propan-2-ol

Name of manufacturer

Shell Chemicals Europe B.V.

Address of manufacturer

Postbus 2334, 3000 CH Rotterdam Netherlands

Location of manufacturing sites

Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601, 3196 KK Rotterdam-Pernis, Netherlands

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | ExxonMobil Chemical Europe |
| Address of manufacturer | Hermeslaan 2, 1831 Machelen, Belgium |
| Location of manufacturing sites | Fawley Refinery and Petrochemical Plant, Fawley, SO45 1TX Southampton United Kingdom
  Baton Rouge Chemical Plant 4999 Scenic Highway, 70805-3359 LA United States |

Active substance

Propan-2-ol

Name of manufacturer

ExxonMobil Chemical Europe

Address of manufacturer

Hermeslaan 2, 1831 Machelen, Belgium

Location of manufacturing sites

Fawley Refinery and Petrochemical Plant, Fawley, SO45 1TX Southampton United Kingdom

Baton Rouge Chemical Plant 4999 Scenic Highway, 70805-3359 LA United States

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 30,3 | 65,66 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

30,3

65,66

2.2.   Type(s) of formulation

| Formulation(s) | AL – Any other liquid
  AE – Aerosol dispenser
  XX – Ready to use wipe impregnated with water based liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

AE – Aerosol dispenser

XX – Ready to use wipe impregnated with water based liquid

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | Meta-SPC 1.1 |
| --- | --- |

Identifier

Meta-SPC 1.1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 60,61 | 65,66 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

60,61

65,66

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Wear eye protection.
  Wear face protection. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Wear eye protection.

Wear face protection.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1. Use # 1 – Use # 1.1 – Disinfection of surfaces in cleanrooms by spraying or mopping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: Bacteria
  Development stage:
  Common name: Yeasts
  Development stage:
  Common name: Fungi
  Development stage:
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Disinfection of cleanroom hard non-porous surfaces in life sciences industry. |
| Application method(s) | Method: Trigger spraying or mopping
  Detailed description:
  Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping. |
| Application rate(s) and frequency | Application Rate: c.a. 18 ml/m2

  Dilution (%): 0
  Number and timing of application:
  As required |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 liter – 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle/container (with and without trigger spray) |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Fungi

Development stage:

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Disinfection of cleanroom hard non-porous surfaces in life sciences industry.

Application method(s)

Method: Trigger spraying or mopping

Detailed description:

Direct application onto surfaces by trigger spraying followed by wiping with a dry wipe for distribution or mopping.

Application rate(s) and frequency

Application Rate: c.a. 18 ml/m2

Dilution (%): 0

Number and timing of application:

As required

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 liter – 10 liters Polyvinylpyrrolidone (PVP) or (High density polyetheylene (HDPE) bottle/container (with and without trigger spray)

4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.

Application by trigger spraying directly onto the surface: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 20 strokes/m2) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Always close the nozzle after use. Do not transfer the product to a trigger sprayer, but apply from a package delivered with trigger sprayer.

Application on surfaces by Mopping: Impregnate the clean mop with the liquid using a mop bucket and apply to the surface to be disinfected. Ensure complete wetting of the surface (max. 18 mL/m2). Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. No additional wiping necessary.

Do not mix product with other products. Do not pour any unused product back into the original container.

4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.

Gloves, eye protection and respiratory protection equipment (RPE) of protection factor of 10 should be worn during mopping. Unprotected personnel should not be present in the room during disinfection by mopping.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.

First Aid Measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Take-off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

Please refer to specific instructions for use for meta-SPC 1

5.2.   Risk mitigation measures

Please refer to specific Risk mitigation measures for meta-SPC 1

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 1

5.4.   Instructions for safe disposal of the product and its packaging

Product

Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging

Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national, and/or international regulations.

Product residues

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C

Shelf life: 24 months

6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.

AEL acute/medium-term/long-term 17,9 mg/kg body weight (bw)/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report on Propan-2-ol in PT2 – Germany – (January 2015).

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Klercide 70/30 IPA | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028425-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,27 |

Trade name(s)

Klercide 70/30 IPA

Market area: EU

Authorisation number

EU-0028425-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,27

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | Meta-SPC 1.2 |
| --- | --- |

Identifier

Meta-SPC 1.2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 2 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 60,61 | 65,66 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

60,61

65,66

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation(s) | XX – Ready to use wipe impregnated with water based liquid |
| --- | --- |

Formulation(s)

XX – Ready to use wipe impregnated with water based liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description

Table 2. Use # 1 – Use # 2.1 – Disinfection of surfaces in cleanroom by wiping

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: Bacteria
  Development stage:
  Common name: Yeasts
  Development stage:
  Common name: Fungi
  Development stage:
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping. |
| Application method(s) | Method: Wiping
  Detailed description:
  Direct application onto surfaces by wiping with pre-wetted wipes. |
| Application rate(s) and frequency | Application Rate: c.a. 10 ml/m2

  Dilution (%): 0
  Number and timing of application:
  Tub (200 wipes/pack, 230x200, Synthetic/cellulose blend): c.a. 0,13 m2 can be disinfected with 1 wipe
  Tub (100 wipes/pack, 200x230, Synthetic/cellulose blend): c.a. 0,23 m2 can be disinfected with 1 wipe
  Mop (10 wipes/pack, 420x250, Polyester/cellulose): c.a. 1,1 m2 can be disinfected with 1 wipe
  Pouch (15 wipes/pack, 200x200, Polyester/cellulose): c.a. 0,33 m2 can be disinfected with 1 wipe
  Pouch (10 wipes/pack, 200x200, 100 % polyester): c.a. 0,51 m2 can be disinfected with 1 wipe
  Pouch (15 wipes/pack, 300x300, Polyester/cellulose): c.a. 0,47 m2 can be disinfected with 1 wipe
  Pouch (10 wipes/pack, 300x300, 100 % polyester): c.a. 0,73 m2 can be disinfected with 1 wipe |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Tub (HDPE) (100-200 wipes/pack, 200x230, Synthetic/cellulose blend)
  Pouch (10-30 wipes/pack, 200x200, Polyester/cellulose, 100 % polyester)
  Pouch (10-30 wipes/pack, 300x300, Polyester/cellulose, 100 % polyester)
  Mop wipe (10-30 wipes/pack, 420x250, Polyester/cellulose) |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Fungi

Development stage:

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Disinfection of cleanroom hard non-porous surfaces in life sciences industry by wiping.

Application method(s)

Method: Wiping

Detailed description:

Direct application onto surfaces by wiping with pre-wetted wipes.

Application rate(s) and frequency

Application Rate: c.a. 10 ml/m2

Dilution (%): 0

Number and timing of application:

Tub (200 wipes/pack, 230x200, Synthetic/cellulose blend): c.a. 0,13 m2 can be disinfected with 1 wipe

Tub (100 wipes/pack, 200x230, Synthetic/cellulose blend): c.a. 0,23 m2 can be disinfected with 1 wipe

Mop (10 wipes/pack, 420x250, Polyester/cellulose): c.a. 1,1 m2 can be disinfected with 1 wipe

Pouch (15 wipes/pack, 200x200, Polyester/cellulose): c.a. 0,33 m2 can be disinfected with 1 wipe

Pouch (10 wipes/pack, 200x200, 100 % polyester): c.a. 0,51 m2 can be disinfected with 1 wipe

Pouch (15 wipes/pack, 300x300, Polyester/cellulose): c.a. 0,47 m2 can be disinfected with 1 wipe

Pouch (10 wipes/pack, 300x300, 100 % polyester): c.a. 0,73 m2 can be disinfected with 1 wipe

Category(ies) of users

Professional

Pack sizes and packaging material

Tub (HDPE) (100-200 wipes/pack, 200x230, Synthetic/cellulose blend)

Pouch (10-30 wipes/pack, 200x200, Polyester/cellulose, 100 % polyester)

Pouch (10-30 wipes/pack, 300x300, Polyester/cellulose, 100 % polyester)

Mop wipe (10-30 wipes/pack, 420x250, Polyester/cellulose)

4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.

Wiping: Wipe surface to be disinfected. Use wipe once. Ensure complete wetting of the surface (max. 10 ml/m2).

About 0,13-1,1 m2 can be disinfected with 1 wipe depending on the wipe.

Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi. Dispose of the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.

For multipack wipes, close the package after opening.

Do not mix with other products.

4.1.2.   Use-specific risk mitigation measures

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.

First Aid Measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

Please refer to specific instructions for use for meta-SPC 2

5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 2

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 2

5.4.   Instructions for safe disposal of the product and its packaging

Product

Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging

Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.

Product residues

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C

Shelf life: 24 months

6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.

AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 Germany – (January 2015).

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Klerwipe 70/30 IPA | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028425-0002 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,27 |

Trade name(s)

Klerwipe 70/30 IPA

Market area: EU

Authorisation number

EU-0028425-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,27

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | Meta-SPC 1.3 |
| --- | --- |

Identifier

Meta-SPC 1.3

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 60,61 | 65,66 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

60,61

65,66

2.2.   Type(s) of formulation of the meta SPC 3

| Formulation(s) | AE – Aerosol dispenser |
| --- | --- |

Formulation(s)

AE – Aerosol dispenser

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Extremely flammable aerosol.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Pressurised container: May burst if heated
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Wear eye protection.
  Wear face protection.
  Do not spray on an open flame or other ignition source.
  Do not pierce or burn, even after use.
  Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F. |

Hazard statements

Extremely flammable aerosol.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Pressurised container: May burst if heated

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Wear eye protection.

Wear face protection.

Do not spray on an open flame or other ignition source.

Do not pierce or burn, even after use.

Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 3. Use # 1 – Use # 3.1 – Disinfection of surfaces in cleanroom by aerosols

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: Bacteria
  Development stage:
  Common name: Yeasts
  Development stage:
  Common name: Fungi
  Development stage:
  Common name: Enveloped viruses
  Development stage: |
| Field(s) of use | Indoor
  Disinfection of cleanroom hard non-porous surfaces in life sciences industry. |
| Application method(s) | Method: Aerosol spraying
  Detailed description:
  Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution. |
| Application rate(s) and frequency | Application Rate: c.a. 18 ml/m2

  Dilution (%): 0
  Number and timing of application:
  As required |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,2 liter – 0,5 liter aluminium can |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Common name: Fungi

Development stage:

Common name: Enveloped viruses

Development stage:

Field(s) of use

Indoor

Disinfection of cleanroom hard non-porous surfaces in life sciences industry.

Application method(s)

Method: Aerosol spraying

Detailed description:

Direct application onto surfaces by aerosol spraying followed by wiping with a dry wipe for distribution.

Application rate(s) and frequency

Application Rate: c.a. 18 ml/m2

Dilution (%): 0

Number and timing of application:

As required

Category(ies) of users

Professional

Pack sizes and packaging material

0,2 liter – 0,5 liter aluminium can

4.1.1.   Use-specific instructions for use

Clean and dry surfaces prior to disinfection.

Application by aerosol spraying: For optimum results hold can upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 7,2 seconds/m2 spraying) followed by wiping with a dry wipe for distribution. Allow to take effect for 5 minutes for bacteria, yeast and enveloped viruses and 15 minutes for fungi.

Do not mix product with other products.

4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects. Intentional misuse by deliberate inhalation may be harmful or fatal.

Chronic Exposure – Health injuries are not known or expected under normal use.

First Aid Measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 3

5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 3

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 3

5.4.   Instructions for safe disposal of the product and its packaging

Product

Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging

Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.

Product residues

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C

Shelf life: 24 months

6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.

AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Klercide 70/30 IPA Aerosol | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028425-0003 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,269 |

Trade name(s)

Klercide 70/30 IPA Aerosol

Market area: EU

Authorisation number

EU-0028425-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,269

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

| Identifier | Meta-SPC 1.4 |
| --- | --- |

Identifier

Meta-SPC 1.4

1.2.   Suffix to the authorisation number

| Number | 1-4 |
| --- | --- |

Number

1-4

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 4 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 30,3 | 30,3 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

30,3

30,3

2.2.   Type(s) of formulation of the meta SPC 4

| Formulation(s) | XX – Ready to use wipe impregnated with water based liquid |
| --- | --- |

Formulation(s)

XX – Ready to use wipe impregnated with water based liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

| Hazard statements | Flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking. |

Hazard statements

Flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

4.   AUTHORISED USE(S) OF THE META SPC 4

4.1.   Use description

Table 4. Use # 1 – Use # 4.1 – Disinfection of non-food and food contact surfaces by pre-wetted wipes

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: Bacteria
  Development stage:
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices. |
| Application method(s) | Method: Wiping
  Detailed description:
  Direct application onto hard non-porous surfaces by wiping. |
| Application rate(s) and frequency | Application Rate: c.a. 10 ml/m2 at room temperature
  Dilution (%): 0
  Number and timing of application:
  Wiping with two superposed wipes.
  About 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | Container (PP) (100 wipes 130x210)
  Container (HDPE) (150 wipes 180x300)
  Bucket (PP) (1 500 wipes 150x210)
  Pouch (PET/PE) (200 wipes 130x210)
  Wipe material (all packagings): blend of Pulp, Polyester, Binder |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.

Application method(s)

Method: Wiping

Detailed description:

Direct application onto hard non-porous surfaces by wiping.

Application rate(s) and frequency

Application Rate: c.a. 10 ml/m2 at room temperature

Dilution (%): 0

Number and timing of application:

Wiping with two superposed wipes.

About 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used.

Category(ies) of users

Professional

Pack sizes and packaging material

Container (PP) (100 wipes 130x210)

Container (HDPE) (150 wipes 180x300)

Bucket (PP) (1 500 wipes 150x210)

Pouch (PET/PE) (200 wipes 130x210)

Wipe material (all packagings): blend of Pulp, Polyester, Binder

4.1.1.   Use-specific instructions for use

Wiping: Clean and dry surfaces prior to disinfection.

Wipe surface to be disinfected with two superposed wipes. Use the wipes once. For optimum results ensure complete wetting of the surface (max. 10 ml/m2), about 0,074-0,222 m2 can be disinfected with two superposed wipes depending on the size of wipe used. Allow to take effect for 15 minutes for bacteria and yeast. Dispose the wipes in the appropriate closed waste bin immediately after use. No additional wiping necessary.

For multipack wipes, close the package after opening.

Do not mix product with other products.

4.1.2.   Use-specific risk mitigation measures

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.

First Aid Measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 4

5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 4

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 4

5.4.   Instructions for safe disposal of the product and its packaging

Product

Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging

Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.

Product residues

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C

Shelf life: 24 months

6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.

AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Eco-Bac Wipes | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028425-0004 1-4 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 30,3 |

Trade name(s)

Eco-Bac Wipes

Market area: EU

Authorisation number

EU-0028425-0004 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

30,3

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

| Identifier | Meta-SPC 1.5 |
| --- | --- |

Identifier

Meta-SPC 1.5

1.2.   Suffix to the authorisation number

| Number | 1-5 |
| --- | --- |

Number

1-5

1.3.   Product type(s)

| Product type(s) | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 5 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 30,3 | 30,3 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

30,3

30,3

2.2.   Type(s) of formulation of the meta SPC 5

| Formulation(s) | AL – Any other liquid |
| --- | --- |

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

| Hazard statements | Flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Wear eye protection.
  Wear face protection. |

Hazard statements

Flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Wear eye protection.

Wear face protection.

4.   AUTHORISED USE(S) OF THE META SPC 5

4.1.   Use description

Table 5. Use # 1 – Use # 5.1 – Disinfection of non-food and food contact surfaces by trigger spray

| Product type | PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Common name: Bacteria
  Development stage:
  Common name: Yeasts
  Development stage: |
| Field(s) of use | Indoor
  Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices. |
| Application method(s) | Method: Trigger spraying
  Detailed description:
  Direct application onto hard non-porous surfaces by trigger spraying. |
| Application rate(s) and frequency | Application Rate: c.a. 18 ml/m2 at room temperature
  Dilution (%): 0
  Number and timing of application:
  As required |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | 0,5 liter – 10 liter HDPE container (with trigger spray) |

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Disinfection of food contact and non-food contact hard non-porous surfaces in: Commercial kitchens, Catering, Food processing and Food Retail, Canteen, Bathrooms and Restrooms in hotels, restaurants, stores, schools, offices.

Application method(s)

Method: Trigger spraying

Detailed description:

Direct application onto hard non-porous surfaces by trigger spraying.

Application rate(s) and frequency

Application Rate: c.a. 18 ml/m2 at room temperature

Dilution (%): 0

Number and timing of application:

As required

Category(ies) of users

Professional

Pack sizes and packaging material

0,5 liter – 10 liter HDPE container (with trigger spray)

4.1.1.   Use-specific instructions for use

Application by trigger spraying: Open the nozzle before use. For optimum results hold bottle upright and apply from a distance of 10 cm to 20 cm. Ensure complete wetting of the surfaces (max. 18 ml/m2, corresponding to 29 strokes/m2). Allow to take effect for 30 seconds for bacteria and yeast. Always close the nozzle after use.

Do not mix product with other products. Do not pour any unused product back into the original container.

4.1.2.   Use-specific risk mitigation measures

Avoid contact with eyes.

4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Potential Health Effects

Eyes – Causes serious eye irritation.

Skin – Health injuries are not known or expected under normal use.

Ingestion – Health injuries are not known or expected under normal use.

Inhalation – Inhalation may cause central nervous system effects.

Chronic Exposure – Health injuries are not known or expected under normal use.

First Aid Measures

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF SWALLOWED: Rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor

4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use (5.4).

4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use (5.5).

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

Please refer to specific instructions of use for meta-SPC 5

5.2.   Risk mitigation measures

Please refer to specific risk mitigation measures for meta-SPC 5

5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to specific information for meta-SPC 5

5.4.   Instructions for safe disposal of the product and its packaging

Product

Where possible recycling is preferred to disposal or incineration. If recycling is not practicable, dispose of in compliance with local regulations. Dispose of wastes in an approved waste disposal facility.

Contaminated packaging

Dispose of as unused product. Empty containers should be taken to an approved waste handling site for recycling or disposal. Do not re-use empty containers. Dispose of in accordance with local, regional, national and/or international regulations.

Product residues

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets...) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store away from direct sunlight and at temperature between 0 °C to 25 °C

Shelf life: 24 months

6.   OTHER INFORMATION

Safety data sheet and technical sheet available for professional users on request.

AEL acute/medium-term/long-term 17,9 mg/kg bw/day for professional workers and AEL acute/medium-term/long-term 10,7 mg/kg bw/day were used for the risk assessment in the Assessment Report of Propan-2-ol in PT2 – Germany – (January 2015).

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

7.1.   Trade name(s), authorisation number and specific composition of each individual product

| Trade name(s) | Sirafan Speed-FR | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0028425-0005 1-5 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 30,3 |

Trade name(s)

Sirafan Speed-FR

Market area: EU

Authorisation number

EU-0028425-0005 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

30,3

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

---

| 17.2.2023 | EN | Official Journal of the European Union | L 50/56 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/56

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/365

of 16 February 2023

terminating the expiry review investigation concerning imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Ukraine

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Articles 9(1) and 11(2) thereof,

Whereas:

1.   PROCEDURE

PROCEDURE

1.1.   Initiation

Initiation

| (1) | Following a request for a review pursuant to Article 11(2) of the basic Regulation the Commission decided to initiate an expiry review investigation regarding the anti-dumping measures in force on imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘HRF’) originating in the Federative Republic of Brazil (‘Brazil’), the Islamic Republic of Iran (‘Iran’), the Russian Federation (‘Russia’) and Ukraine (‘the countries concerned’). It published a Notice of Initiation in the Official Journal of the European Union on 5 October 2022 (the ‘Notice of Initiation’) (2). |
| --- | --- |

(1)

Following a request for a review pursuant to Article 11(2) of the basic Regulation the Commission decided to initiate an expiry review investigation regarding the anti-dumping measures in force on imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘HRF’) originating in the Federative Republic of Brazil (‘Brazil’), the Islamic Republic of Iran (‘Iran’), the Russian Federation (‘Russia’) and Ukraine (‘the countries concerned’). It published a Notice of Initiation in the Official Journal of the European Union on 5 October 2022 (the ‘Notice of Initiation’) (2).

Official Journal of the European Union

2

| (2) | The request for the review was submitted on 4 July 2022 by the European Steel Association EUROFER (‘the applicant’) on behalf of the Union industry of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘HRF’) in the sense of Article 5(4) of the basic Regulation. |
| --- | --- |

(2)

The request for the review was submitted on 4 July 2022 by the European Steel Association EUROFER (‘the applicant’) on behalf of the Union industry of certain hot-rolled flat products of iron, non-alloy or other alloy steel (‘HRF’) in the sense of Article 5(4) of the basic Regulation.

| (3) | The request contained sufficient evidence that the expiry of the measures would be likely to result in recurrence and continuation of dumping and recurrence of injury to the Union industry. |
| --- | --- |

(3)

The request contained sufficient evidence that the expiry of the measures would be likely to result in recurrence and continuation of dumping and recurrence of injury to the Union industry.

1.2.   Interested parties

Interested parties

| (4) | In the Notice of Initiation, interested parties were invited to contact the Commission in order to participate in the investigation. In addition, the Commission specifically informed the applicant, the known Union producers and associations, as well as the authorities of the countries concerned about the initiation of the review investigation and invited them to participate. |
| --- | --- |

(4)

In the Notice of Initiation, interested parties were invited to contact the Commission in order to participate in the investigation. In addition, the Commission specifically informed the applicant, the known Union producers and associations, as well as the authorities of the countries concerned about the initiation of the review investigation and invited them to participate.

2.   PRODUCT UNDER INVESTIGATION

PRODUCT UNDER INVESTIGATION

| (5) | The product subject to this review is certain flat-rolled products of iron, non-alloy steel or other alloy steel, whether or not in coils (including ‘cut-to-length’ and ‘narrow strip’ products), not further worked than hot-rolled, not clad, plated or coated (‘HRF’ or ‘product under review’).
  The following products are not covered by this review:






  (i) | products of stainless steel and grain-oriented silicon electrical steel; |
| --- | --- | --- |

(5)

The product subject to this review is certain flat-rolled products of iron, non-alloy steel or other alloy steel, whether or not in coils (including ‘cut-to-length’ and ‘narrow strip’ products), not further worked than hot-rolled, not clad, plated or coated (‘HRF’ or ‘product under review’).

The following products are not covered by this review:

(i)

products of stainless steel and grain-oriented silicon electrical steel;

| (ii) | products of tool steel and high-speed steel; |
| --- | --- |

(ii)

products of tool steel and high-speed steel;

| (iii) | products, not in coils, without patterns in relief, of a thickness exceeding 10 mm and of a width of 600 mm or more; and |
| --- | --- |

(iii)

products, not in coils, without patterns in relief, of a thickness exceeding 10 mm and of a width of 600 mm or more; and

| (iv) | products, not in coils, without patterns in relief, of a thickness of 4,75 mm or more but not exceeding 10 mm and of a width of 2 050 mm or more. |
| --- | --- |

(iv)

products, not in coils, without patterns in relief, of a thickness of 4,75 mm or more but not exceeding 10 mm and of a width of 2 050 mm or more.

The product under review is currently falling under CN codes 7208 10 00, 7208 25 00, 7208 26 00, 7208 27 00, 7208 36 00, 7208 37 00, 7208 38 00, 7208 39 00, 7208 40 00, 7208 52 10, 7208 52 99, 7208 53 10, 7208 53 90, 7208 54 00, 7211 13 00, 7211 14 00, 7211 19 00, ex 7225 19 10 (TARIC code 7225191090), 7225 30 90, ex 7225 40 60 (TARIC code 7225406090), 7225 40 90, ex 7226 19 10 (TARIC codes 7226191091, 7226191095), 7226 91 91 and 7226 91 99. These CN and TARIC codes are given for information only, without prejudice to a subsequent change in the tariff classification.

3.   WITHDRAWAL OF THE COMPLAINT

WITHDRAWAL OF THE COMPLAINT

| (6) | On 23 November 2022 the applicant withdrew its request for an expiry review investigation as far as Ukraine is concerned. |
| --- | --- |

(6)

On 23 November 2022 the applicant withdrew its request for an expiry review investigation as far as Ukraine is concerned.

| (7) | In its withdrawal the applicant considered that, given the developments that have taken place since the request was lodged (Q1/2022) and, especially, since the expiry review was subsequently initiated, circumstances with regard to Ukraine have changed to such an extent that it is no longer appropriate to pursue an expiry review against HRF imports from Ukraine. Notably, the applicant referred to the destruction of a major part of HRF capacities in Ukraine as well as of the Ukrainian energy infrastructure. The applicant further noted that military conflict, or at least the consequences thereof as regards Ukraine, would be of a lasting nature. In particular, steel capacities in Ukraine are not expected to return to normal operations in the short-medium term and it is therefore not likely that Ukrainian HRF exports would be able to contribute to a recurrence of injury to the Union industry any time soon. |
| --- | --- |

(7)

In its withdrawal the applicant considered that, given the developments that have taken place since the request was lodged (Q1/2022) and, especially, since the expiry review was subsequently initiated, circumstances with regard to Ukraine have changed to such an extent that it is no longer appropriate to pursue an expiry review against HRF imports from Ukraine. Notably, the applicant referred to the destruction of a major part of HRF capacities in Ukraine as well as of the Ukrainian energy infrastructure. The applicant further noted that military conflict, or at least the consequences thereof as regards Ukraine, would be of a lasting nature. In particular, steel capacities in Ukraine are not expected to return to normal operations in the short-medium term and it is therefore not likely that Ukrainian HRF exports would be able to contribute to a recurrence of injury to the Union industry any time soon.

4.   CONCLUSION AND DISCLOSURE

CONCLUSION AND DISCLOSURE

| (8) | In accordance with Article 9(1) of the basic Regulation, the investigation may be terminated, unless such termination would not be in the Union interest. |
| --- | --- |

(8)

In accordance with Article 9(1) of the basic Regulation, the investigation may be terminated, unless such termination would not be in the Union interest.

| (9) | The investigation had not brought to light any considerations demonstrating that such termination would not be in the Union interest. |
| --- | --- |

(9)

The investigation had not brought to light any considerations demonstrating that such termination would not be in the Union interest.

| (10) | The Commission therefore considered that the review investigation should be terminated as far as imports from Ukraine are concerned. The Commission will continue the review investigation with regard to imports from Brazil, Iran and Russia. |
| --- | --- |

(10)

The Commission therefore considered that the review investigation should be terminated as far as imports from Ukraine are concerned. The Commission will continue the review investigation with regard to imports from Brazil, Iran and Russia.

| (11) | Since the measures are not prolonged as regards Ukraine, any duties collected from the date of the initiation of the expiry review investigation on goods that were customs-cleared as regards imports of the product under review originating in Ukraine shall be repaid, provided that this is requested from national customs authorities and granted by those authorities in accordance with the applicable Union customs legislation concerning repayment and remission of duty. The Commission noted that, pursuant to Regulation (EU) 2022/870 of the European Parliament and of the Council (3), anti-dumping duties on imports originating in Ukraine as of 4 June 2022 should not be collected at any point in time. Therefore, in this case, no duty is due to be reimbursed because, prior to the date of initiation of the expiry review investigation, the European Union already suspended the collection of anti-dumping duties on Ukrainian imports, including on HRF. |
| --- | --- |

(11)

Since the measures are not prolonged as regards Ukraine, any duties collected from the date of the initiation of the expiry review investigation on goods that were customs-cleared as regards imports of the product under review originating in Ukraine shall be repaid, provided that this is requested from national customs authorities and granted by those authorities in accordance with the applicable Union customs legislation concerning repayment and remission of duty. The Commission noted that, pursuant to Regulation (EU) 2022/870 of the European Parliament and of the Council (3), anti-dumping duties on imports originating in Ukraine as of 4 June 2022 should not be collected at any point in time. Therefore, in this case, no duty is due to be reimbursed because, prior to the date of initiation of the expiry review investigation, the European Union already suspended the collection of anti-dumping duties on Ukrainian imports, including on HRF.

3

| (12) | On 21 December 2022 the Commission disclosed to all interested parties its intention to terminate the expiry review investigation as far as Ukraine is concerned and granted them an opportunity to submit comments. |
| --- | --- |

(12)

On 21 December 2022 the Commission disclosed to all interested parties its intention to terminate the expiry review investigation as far as Ukraine is concerned and granted them an opportunity to submit comments.

| (13) | The Commission received no comments that would lead to the conclusion that such termination would not be in the Union interest. |
| --- | --- |

(13)

The Commission received no comments that would lead to the conclusion that such termination would not be in the Union interest.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of the basic Regulation, |
| --- | --- |

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of the basic Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The expiry review investigation in so far it concerns anti-dumping measures applicable to imports of certain hot-rolled flat products of iron, non-alloy or other alloy steel originating in Ukraine is terminated.

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, 16 February 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 176, 30.6.2016, p. 21.

1

(2)  
  OJ C 384, 5.10.2022, p. 3.

2

(3)  Regulation (EU) 2022/870 of the European Parliament and of the Council of 30 May 2022 on temporary trade-liberalisation measures supplementing trade concessions applicable to Ukrainian products under the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part (OJ L 152, 3.6.2022, p. 103).

3

---

| 17.2.2023 | EN | Official Journal of the European Union | L 50/59 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/59

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/366

of 16 February 2023

concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europa N.V.)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) and Article 13(3) thereof,

Whereas:

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

(1)

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

| (2) | A preparation of Bacillus velezensis ATCC PTA-6737, previously taxonomically identified as Bacillus subtilis ATCC PTA-6737, was authorised for a period of 10 years as a feed additive for chickens for fattening by Commission Regulation (EU) No 107/2010 (2), for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches by Commission Implementing Regulation (EU) No 885/2011 (3), for weaned piglets and weaned Suidae other than Sus Scrofa domesticus by Commission Implementing Regulation (EU) No 306/2013 (4), for turkeys for fattening and turkeys reared for breeding by Commission Implementing Regulation (EU) No 787/2013 (5), for laying hens and minor poultry species for laying by Commission Implementing Regulation (EU) 2015/1020 (6) and for sows by Commission Implementing Regulation (EU) 2017/2276 (7). |
| --- | --- |

(2)

A preparation of Bacillus velezensis ATCC PTA-6737, previously taxonomically identified as Bacillus subtilis ATCC PTA-6737, was authorised for a period of 10 years as a feed additive for chickens for fattening by Commission Regulation (EU) No 107/2010 (2), for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches by Commission Implementing Regulation (EU) No 885/2011 (3), for weaned piglets and weaned Suidae other than Sus Scrofa domesticus by Commission Implementing Regulation (EU) No 306/2013 (4), for turkeys for fattening and turkeys reared for breeding by Commission Implementing Regulation (EU) No 787/2013 (5), for laying hens and minor poultry species for laying by Commission Implementing Regulation (EU) 2015/1020 (6) and for sows by Commission Implementing Regulation (EU) 2017/2276 (7).

| (3) | In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Bacillus velezensis ATCC PTA-6737 for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, including for a modification of the minimum concentration of the active agent in the preparation. In accordance with Article 7 of Regulation (EC) No 1831/2003, another application was submitted for a new use of that preparation for ornamental birds, sporting and game birds. Those applications requested that additive to be classified in the additive category ‘zootechnical additives’ and the functional group ‘gut flora stabilisers’ and were accompanied by the particulars and documents required respectively under Article 14(2) and Article 7(3) of that Regulation. |
| --- | --- |

(3)

In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation of Bacillus velezensis ATCC PTA-6737 for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, including for a modification of the minimum concentration of the active agent in the preparation. In accordance with Article 7 of Regulation (EC) No 1831/2003, another application was submitted for a new use of that preparation for ornamental birds, sporting and game birds. Those applications requested that additive to be classified in the additive category ‘zootechnical additives’ and the functional group ‘gut flora stabilisers’ and were accompanied by the particulars and documents required respectively under Article 14(2) and Article 7(3) of that Regulation.

| (4) | In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of the preparation of Bacillus subtilis ATCC PTA-6737 as laid down in Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276, in relation to the change of the name of the additive from Bacillus subtilis ATCC PTA-6737 to Bacillus velezensis ATCC PTA-6737, as regards the strain taxonomy. That application was accompanied by the relevant data supporting the request for change, as required by Article 13(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

In accordance with Article 13(3) of Regulation (EC) No 1831/2003, an application was submitted for the modification of the terms of the authorisation of the preparation of Bacillus subtilis ATCC PTA-6737 as laid down in Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276, in relation to the change of the name of the additive from Bacillus subtilis ATCC PTA-6737 to Bacillus velezensis ATCC PTA-6737, as regards the strain taxonomy. That application was accompanied by the relevant data supporting the request for change, as required by Article 13(3) of Regulation (EC) No 1831/2003.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (8) that the applicant has provided evidence that the preparation of Bacillus velezensis ATCC PTA-6737 remains safe for chickens for fattening, chickens reared for laying and minor poultry species (except for laying purposes) (9), consumers and the environment, taking notably into consideration the modification of the minimum concentration of the active agent in the preparation. It also concluded that the preparation is non-irritant to skin and eyes and is not a dermal sensitiser. In addition, the Authority concluded that the preparation has the potential to be efficacious as a zootechnical additive for ornamental, sporting and game birds. The Authority does not consider that there is a need for specific requirements of post-market monitoring. |
| --- | --- |

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 September 2020 (8) that the applicant has provided evidence that the preparation of Bacillus velezensis ATCC PTA-6737 remains safe for chickens for fattening, chickens reared for laying and minor poultry species (except for laying purposes) (9), consumers and the environment, taking notably into consideration the modification of the minimum concentration of the active agent in the preparation. It also concluded that the preparation is non-irritant to skin and eyes and is not a dermal sensitiser. In addition, the Authority concluded that the preparation has the potential to be efficacious as a zootechnical additive for ornamental, sporting and game birds. The Authority does not consider that there is a need for specific requirements of post-market monitoring.

| (6) | In its opinion of 23 March 2022 (10), the Authority concluded that the additive should be taxonomically designated as Bacillus velezensis ATCC PTA-6737. It further concluded that the additive is not a dermal or eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. |
| --- | --- |

(6)

In its opinion of 23 March 2022 (10), the Authority concluded that the additive should be taxonomically designated as Bacillus velezensis ATCC PTA-6737. It further concluded that the additive is not a dermal or eye irritant or a skin sensitiser but should be considered a respiratory sensitiser.

| (7) | In accordance with Article 5(4), points (a), (b) and (c) of Commission Regulation (EC) No 378/2005 (11), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment are applicable for the current applications. |
| --- | --- |

(7)

In accordance with Article 5(4), points (a), (b) and (c) of Commission Regulation (EC) No 378/2005 (11), the Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the previous assessment are applicable for the current applications.

| (8) | The assessment of the preparation of Bacillus velezensis ATCC PTA-6737 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. As for ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, game and sporting birds should be considered as minor poultry species and should therefore be included in the scope of the renewal of authorisation. Accordingly, the authorisation of that additive should be renewed for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes and the use of that additive should be authorised for ornamental birds. |
| --- | --- |

(8)

The assessment of the preparation of Bacillus velezensis ATCC PTA-6737 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. As for ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches, game and sporting birds should be considered as minor poultry species and should therefore be included in the scope of the renewal of authorisation. Accordingly, the authorisation of that additive should be renewed for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes and the use of that additive should be authorised for ornamental birds.

| (9) | The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Those protective measures should comply with Union legislation on worker safety requirements. |
| --- | --- |

(9)

The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. Those protective measures should comply with Union legislation on worker safety requirements.

| (10) | The name of the additive should be taxonomically designated as Bacillus velezensis ATCC PTA-6737 and Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276 should therefore be amended accordingly. |
| --- | --- |

(10)

The name of the additive should be taxonomically designated as Bacillus velezensis ATCC PTA-6737 and Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276 should therefore be amended accordingly.

| (11) | As a consequence of the renewal of the authorisation of the preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive, Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 should be repealed. |
| --- | --- |

(11)

As a consequence of the renewal of the authorisation of the preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive, Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 should be repealed.

| (12) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Bacillus velezensis ATCC PTA-6737, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation and from the change of the name of the additive. |
| --- | --- |

(12)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Bacillus velezensis ATCC PTA-6737, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation and from the change of the name of the additive.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(13)

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

HAS ADOPTED THIS REGULATION:

Article 1

Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ is renewed for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, subject to the conditions laid down in that Annex.

Article 2

Authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ is authorised for ornamental birds, subject to the conditions laid down in that Annex.

Article 3

Amendments to Implementing Regulation (EU) No 306/2013

Implementing Regulation (EU) No 306/2013 is amended as follows:

| (1) | In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’. |
| --- | --- |

(1)

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Bacillus subtilis

Bacillus velezensis

| (2) | In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’; |
| --- | --- |

(2)

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

Bacillus subtilis

Bacillus velezensis

| (3) | In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’. |
| --- | --- |

(3)

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Bacillus subtilis

Bacillus velezensis

Article 4

Amendments to Implementing Regulation (EU) No 787/2013

Implementing Regulation (EU) No 787/2013 is amended as follows:

| (1) | In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’; |
| --- | --- |

(1)

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

Bacillus subtilis

Bacillus velezensis

| (2) | In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’; |
| --- | --- |

(2)

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

Bacillus subtilis

Bacillus velezensis

| (3) | In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’. |
| --- | --- |

(3)

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Bacillus subtilis

Bacillus velezensis

Article 5

Amendments to Implementing Regulation (EU) 2015/1020

Implementing Regulation (EU) 2015/1020 is amended as follows:

| (1) | In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’; |
| --- | --- |

(1)

In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

Bacillus subtilis

Bacillus velezensis

| (2) | In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis ATCC PTA-6737’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’; |
| --- | --- |

(2)

In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis ATCC PTA-6737’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

Bacillus subtilis

Bacillus velezensis

| (3) | In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’. |
| --- | --- |

(3)

In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Bacillus subtilis

Bacillus velezensis

Article 6

Amendments to Implementing Regulation (EU) 2017/2276

Implementing Regulation (EU) 2017/2276 is amended as follows:

(1)   In the title, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(2)   In the third column of the Annex, ‘Additive’, the words ‘Bacillus subtilis ATCC PTA-6737’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’;

(3)   In the fourth column of the Annex, ‘Composition, chemical formula, description, analytical method’, the words ‘Bacillus subtilis (ATCC PTA-6737)’ are replaced by the words ‘Bacillus velezensis ATCC PTA-6737’.

Article 7

Repeal

Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 are repealed.

Article 8

Transitional measures

1.   The preparation specified in the Annex, as well as in Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020 and Implementing Regulation (EU) 2017/2276, and premixtures containing it, which are produced and labelled before 9 September 2023 in accordance with the rules applicable before 9 March 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 9 March 2024 in accordance with the rules applicable before 9 March 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

Article 9

Entry into force

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

Official Journal of the European Union.

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

Done at Brussels, 16 February 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Regulation (EU) No 107/2010 of 8 February 2010 concerning the authorisation of Bacillus subtilis ATCC PTA-6737 as a feed additive for chickens for fattening (holder of authorisation Kemin Europa NV) (OJ L 36, 9.2.2010, p. 1).

2

Bacillus subtilis

(3)  Commission Implementing Regulation (EU) No 885/2011 of 5 September 2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of authorisation Kemin Europa N.V.) (OJ L 229, 6.9.2011, p. 3).

3

Bacillus subtilis

(4)  Commission Implementing Regulation (EU) No 306/2013 of 2 April 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.) (OJ L 91, 3.4.2013, p. 5).

4

Bacillus subtilis

Sus scrofa domesticus

(5)  Commission Implementing Regulation (EU) No 787/2013 of 16 August 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.) (OJ L 220, 17.8.2013, p. 15).

5

Bacillus subtilis

(6)  Commission Implementing Regulation (EU) 2015/1020 of 29 June 2015 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europa NV) (OJ L 163, 30.6.2015, p. 22).

6

Bacillus subtilis

(7)  Commission Implementing Regulation (EU) 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europa N.V.) (OJ L 326, 9.12.2017, p. 50).

7

Bacillus subtilis

(8)  EFSA Journal 2020;18(11):6280.

8

(9)  Chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes.

9

(10)  EFSA Journal 2022;20(4):7244.

10

(11)  Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8).

11

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category: zootechnical additives. Functional group: gut flora stabilisers |
| 4b1823i | Kemin Europa N.V. | Bacillus velezensis ATCC PTA-6737 | Additive composition

  Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 × 1010 CFU/g | Chickens for fattening
  Chickens reared for laying
  Minor poultry species except minor poultry for laying
  Ornamental birds | - | 1 × 107 | - | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

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

Category: zootechnical additives. Functional group: gut flora stabilisers

4b1823i

Kemin Europa N.V.

Bacillus velezensis ATCC PTA-6737

Additive composition

Preparation of Bacillus velezensis ATCC PTA-6737 containing a minimum of 8 × 1010 CFU/g

Chickens for fattening

Chickens reared for laying

Minor poultry species except minor poultry for laying

Ornamental birds

-

1 × 107

-

1.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 2. | The additive is compatible with the following coccidiostats, provided they are authorised for the relevant species: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride. |
| --- | --- |

2.

The additive is compatible with the following coccidiostats, provided they are authorised for the relevant species: diclazuril, decoquinate, salinomycin sodium, narasin/nicarbazin, lasalocid A sodium, maduramycin ammonium, monensin sodium, narasin or robenidine hydrochloride.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

9 March 2033

Characterisation of the active substance

Viable spores of Bacillus velezensis ATCC PTA-6737

Analytical method
   (1)

Enumeration: spread plate method using tryptone soya agar (EN 15784)

Identification: pulsed-field gel electrophoresis (PFGE) method. or DNA sequencing methods

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

---

DECISIONS

| 17.2.2023 | EN | Official Journal of the European Union | L 50/65 |
| --- | --- | --- | --- |

17.2.2023

EN

Official Journal of the European Union

L 50/65

---

DECISION (EU) 2023/367 OF THE EUROPEAN PARLIAMENT

of 19 January 2023

extending the term of office of the Committee of Inquiry to investigate the use of the Pegasus and equivalent surveillance spyware

THE EUROPEAN PARLIAMENT,

| — | having regard to the proposal by the Conference of Presidents, |
| --- | --- |

—

having regard to the proposal by the Conference of Presidents,

| — | having regard to Article 226 of the Treaty on the Functioning of the European Union, |
| --- | --- |

—

having regard to Article 226 of the Treaty on the Functioning of the European Union,

| — | having regard to Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament’s right of inquiry (1), |
| --- | --- |

—

having regard to Decision 95/167/EC, Euratom, ECSC of the European Parliament, the Council and the Commission of 19 April 1995 on the detailed provisions governing the exercise of the European Parliament’s right of inquiry (1),

1

| — | having regard to Decision (EU) 2022/480 of the European Parliament of 10 March 2022 on setting up a committee of inquiry to investigate the use of the Pegasus and equivalent surveillance spyware, and defining the subject of the inquiry, as well as the responsibilities, numerical strength and term of office of the committee (2), |
| --- | --- |

—

having regard to Decision (EU) 2022/480 of the European Parliament of 10 March 2022 on setting up a committee of inquiry to investigate the use of the Pegasus and equivalent surveillance spyware, and defining the subject of the inquiry, as well as the responsibilities, numerical strength and term of office of the committee (2),

2

| — | having regard to Rule 208(11) of its Rules of Procedure, |
| --- | --- |

—

having regard to Rule 208(11) of its Rules of Procedure,

| A. | whereas the Committee of Inquiry requested an extension of its term of office in order to enable it to fulfil its mandate fully and properly; |
| --- | --- |

A.

whereas the Committee of Inquiry requested an extension of its term of office in order to enable it to fulfil its mandate fully and properly;

1.

Decides to extend by three months the term of office of the Committee of Inquiry.

For the European Parliament

The President

R. METSOLA

---

(1)  
  OJ L 113, 19.5.1995, p. 1.

1

(2)  
  OJ L 98, 25.3.2022, p. 72.

2

---