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)

• CELEX: Implementing Regulation (EU) 2023/1755
• Articles: 5

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.

Schedules & Appendices

ANNEX I

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

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

‘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.

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