# L_2023224EN.01001801.xml

| 12.9.2023 | EN | Official Journal of the European Union | L 224/18 |
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12.9.2023

EN

Official Journal of the European Union

L 224/18

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1755

of 11 September 2023

renewing the approval of the low-risk active substance fat distillation residues in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) in conjunction with Article 22(1) thereof,

Whereas:

| (1) | Commission Directive 2008/127/EC (2) included fat distillation residues as an active substance in Annex I to Council Directive 91/414/EEC (3). |
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(1)

Commission Directive 2008/127/EC (2) included fat distillation residues as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | In accordance with Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

In accordance with Article 78(3) of Regulation (EC) No 1107/2009, active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance fat distillation residues, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2024. |
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(3)

The approval of the active substance fat distillation residues, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2024.

| (4) | An application for the renewal of the approval of the active substance fat distillation residues was submitted to Czechia, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article. |
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(4)

An application for the renewal of the approval of the active substance fat distillation residues was submitted to Czechia, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) and within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State. |
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(5)

The applicant submitted the supplementary dossiers required to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be admissible by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 25 February 2021. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of fat distillation residues. |
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(6)

The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 25 February 2021. In its draft renewal assessment report the rapporteur Member State proposed to renew the approval of fat distillation residues.

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
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(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 5 January 2023, the Authority communicated to the Commission its conclusion (6), according to which fat distillation residues can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(8)

On 5 January 2023, the Authority communicated to the Commission its conclusion (6), according to which fat distillation residues can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (9) | The Commission presented a renewal report and a draft Regulation regarding fat distillation residues to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 25 May 2023, respectively. |
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(9)

The Commission presented a renewal report and a draft Regulation regarding fat distillation residues to the Standing Committee on Plants, Animals, Food and Feed on 22 March 2023 and on 25 May 2023, respectively.

| (10) | The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration. |
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(10)

The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third subparagraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicant submitted its comments, which have been carefully examined and taken into consideration.

| (11) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance fat distillation residues that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. |
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(11)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance fat distillation residues that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

| (12) | The Commission further considers that fat distillation residues is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Fat distillation residues is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009. |
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(12)

The Commission further considers that fat distillation residues is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Fat distillation residues is not a substance of concern and fulfils the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

| (13) | It is therefore appropriate to renew the approval of fat distillation residues as a low-risk active substance. |
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(13)

It is therefore appropriate to renew the approval of fat distillation residues as a low-risk active substance.

| (14) | In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of fat distillation residues and a maximum amount of the impurity nickel in the fat distillation residues as manufactured in order to ensure the safety of the active substance when used in plant protection products. |
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(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge and the outcome of the risk assessment, it is, however, necessary to set a minimum purity of fat distillation residues and a maximum amount of the impurity nickel in the fat distillation residues as manufactured in order to ensure the safety of the active substance when used in plant protection products.

| (15) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(15)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (16) | Commission Implementing Regulation (EU) 2023/1446 (7) extended the approval period of fat distillation residues to 15 December 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date. |
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(16)

Commission Implementing Regulation (EU) 2023/1446 (7) extended the approval period of fat distillation residues to 15 December 2024 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(17)

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 approval of the active substance

The approval of the active substance fat distillation residues, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II.

Article 3

Entry into force and date of application

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

It shall apply from 1 November 2023.

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

Done at Brussels, 11 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

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

1

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

2

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

3

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

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  Conclusion on the peer review of the pesticide risk assessment of the active substance fat distillation residues. EFSA Journal doi:10.2903/j.efsa.2023.7811.

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2023/1446 of 12 July 2023 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,5-dichlorobenzoic acid methylester, acetic acid, aluminium ammonium sulphate, aluminium phosphide, aluminium silicate, calcium carbide, cymoxanil, dodemorph, ethylene, extract from tea tree, fat distillation residues, fatty acids C7-C20, flonicamid (IKI-220), gibberellic acid, gibberellins, halosulfuron-methyl, hydrolysed proteins, iron sulphate, magnesium phosphide, maltodextrin, metamitron, plant oils/clove oil, plant oils/rape seed oil, plant oils/spear mint oil, pyrethrins, sulcotrione, tebuconazole and urea (OJ L 178, 13.7.2023, p. 1).

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
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| Fat distillation residues
  CAS No not available
  915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded)
  palmitic acid min 19 % of cleaved fatty acids
  stearic acid min 18 % of cleaved fatty acids
  oleic acid min 37 % of cleaved fatty acids
  acid value min 70 mg KOH/g
  The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:
  nickel max 0,1 g/kg | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Fat distillation residues

CAS No not available

915 (CIPAC No)

Not available

≥ 400 g/kg of cleaved fatty acids (free/ester bonded)

palmitic acid min 19 % of cleaved fatty acids

stearic acid min 18 % of cleaved fatty acids

oleic acid min 37 % of cleaved fatty acids

acid value min 70 mg KOH/g

The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:

nickel max 0,1 g/kg

1 November 2023

31 October 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

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(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.

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ANNEX II

The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, entry 229 on fat distillation residues is deleted; |
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(1)

in Part A, entry 229 on fat distillation residues is deleted;

| (2) | in Part D, the following entry is added:











  No. | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘44 | Fat distillation residues
  CAS No not available
  915 (CIPAC No) | Not available | ≥ 400 g/kg of cleaved fatty acids (free/ester bonded)
  palmitic acid min 19 % of cleaved fatty acids
  stearic acid min 18 % of cleaved fatty acids
  oleic acid min 37 % of cleaved fatty acids
  acid value min 70 mg KOH/g
  The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:
  nickel max 0,1 g/kg | 1 November 2023 | 31 October 2038 | For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate. |

(2)

in Part D, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘44

Fat distillation residues

CAS No not available

915 (CIPAC No)

Not available

≥ 400 g/kg of cleaved fatty acids (free/ester bonded)

palmitic acid min 19 % of cleaved fatty acids

stearic acid min 18 % of cleaved fatty acids

oleic acid min 37 % of cleaved fatty acids

acid value min 70 mg KOH/g

The following impurity is of toxicological concern and shall not exceed the following levels in the technical material:

nickel max 0,1 g/kg

1 November 2023

31 October 2038

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on fat distillation residues, and in particular Appendices I and II thereof, shall be taken into account.

Conditions of use shall include risk mitigation measures, where appropriate.

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(1)  Further details on the identity and the specification of the active substance are provided in the renewal report.’

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