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)
Corrected by
  • Corrigendum to 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, 32023R1755R(01), December 22, 2023
Commission Implementing Regulation (EU) 2023/1755of 11 September 2023renewing 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)
Article 1Renewal of the approval of the active substanceThe 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 2Amendments to Implementing Regulation (EU) No 540/2011The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II.
Article 3Entry into force and date of applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 November 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Further details on the identity and the specification of the active substance are provided in the renewal report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
Fat distillation residuesCAS No not available915 (CIPAC No)Not available≥ 400 g/kg of cleaved fatty acids (free/ester bonded)palmitic acid min 19 % of cleaved fatty acidsstearic acid min 18 % of cleaved fatty acidsoleic acid min 37 % of cleaved fatty acidsacid value min 70 mg KOH/gThe following impurity is of toxicological concern and shall not exceed the following levels in the technical material:nickel max 0,1 g/kg1 November 202331 October 2038For 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.
ANNEX IIThe 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;(2)in Part D, the following entry is added:
Further details on the identity and the specification of the active substance are provided in the renewal report."
No.Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"46Fat distillation residuesCAS No not available915 (CIPAC No)Not available≥ 400 g/kg of cleaved fatty acids (free/ester bonded)palmitic acid min 19 % of cleaved fatty acidsstearic acid min 18 % of cleaved fatty acidsoleic acid min 37 % of cleaved fatty acidsacid value min 70 mg KOH/gThe following impurity is of toxicological concern and shall not exceed the following levels in the technical material:nickel max 0,1 g/kg1 November 202331 October 2038For 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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Further details on the identity and the specification of the active substance are provided in the renewal report."
Article 1Renewal of the approval of the active substanceThe 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 2Amendments to Implementing Regulation (EU) No 540/2011The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II.
Article 3Entry into force and date of applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 November 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Further details on the identity and the specification of the active substance are provided in the renewal report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
Fat distillation residuesCAS No not available915 (CIPAC No)Not available≥ 400 g/kg of cleaved fatty acids (free/ester bonded)palmitic acid min 19 % of cleaved fatty acidsstearic acid min 18 % of cleaved fatty acidsoleic acid min 37 % of cleaved fatty acidsacid value min 70 mg KOH/gThe following impurity is of toxicological concern and shall not exceed the following levels in the technical material:nickel max 0,1 g/kg1 November 202331 October 2038For 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.
ANNEX IIThe 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;(2)in Part D, the following entry is added:
Further details on the identity and the specification of the active substance are provided in the renewal report."
No.Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"46Fat distillation residuesCAS No not available915 (CIPAC No)Not available≥ 400 g/kg of cleaved fatty acids (free/ester bonded)palmitic acid min 19 % of cleaved fatty acidsstearic acid min 18 % of cleaved fatty acidsoleic acid min 37 % of cleaved fatty acidsacid value min 70 mg KOH/gThe following impurity is of toxicological concern and shall not exceed the following levels in the technical material:nickel max 0,1 g/kg1 November 202331 October 2038For 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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Further details on the identity and the specification of the active substance are provided in the renewal report."