LegalizeCommission 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)
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.
It shall apply from 1 November 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| 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. |
| (1) Further details on the identity and the specification of the active substance are provided in the renewal report. |
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;
(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 ‘ 46 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. (1) Further details on the identity and the specification of the active substance are provided in the renewal report.’
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