Commission Implementing Regulation (EU) 2024/821 of 8 March 2024 renewing the approval of the low-risk active substance hydrolysed proteins 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

• CELEX: Implementing Regulation (EU) 2024/821
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance hydrolysed proteins, as specified in Annex I to this Regulation, 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 to this Regulation.

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 May 2024.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Hydrolysed proteins

CAS No: Not applicable

CIPAC No: 901

Not available

Hydrolysed proteins. Animal tissues hydrolysate excluding ruminants hides and skins (no ISO common name):

—

708 g/kg on a dry weight basis [range in TK (technical concentrate) 400-434 g/kg].

Hydrolysed proteins. Urea enriched beet molasses, hydrolysed (no ISO common name):

—

110 g/kg on a dry weight basis [range in TK (technical concentrate) 90-110 g/kg].

Hydrolysed Proteins. Collagen protein Hydrolysate (no ISO common name):

—

582 g/kg on a dry weight basis [range in TK (technical concentrate) 249-262 g/kg].

Lead, cadmium, arsenic, mercury and biuret in accordance with Regulation (EU) 2019/1009 on fertilising products.

Formaldehyde below 1 g/kg.

1 May 2024

30 April 2039

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 hydrolysed proteins, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the specification of the technical material for ‘hydrolysed proteins-urea enriched beet molasses, hydrolysed’ as commercially manufactured on the basis of an analysis of at least five representative batches.

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

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

ANNEX II

ANNEX II

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

(1)

in Part A, entry 234 on hydrolysed proteins 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

‘47

Hydrolysed proteins

CAS No: Not applicable

CIPAC No: 901

Not available

Hydrolysed proteins. Animal tissues hydrolysate excluding ruminants hides and skins (no ISO common name):

—

708 g/kg on a dry weight basis [range in TK (technical concentrate) 400-434 g/kg].

Hydrolysed proteins. Urea enriched beet molasses, hydrolysed (no ISO common name):

—

110 g/kg on a dry weight basis [range in TK (technical concentrate) 90-110 g/kg].

Hydrolysed Proteins. Collagen protein Hydrolysate (no ISO common name):

—

582 g/kg on a dry weight basis [range in TK (technical concentrate) 249-262 g/kg].

Lead, cadmium, arsenic, mercury and biuret in accordance with Regulation (EU) 2019/1009 on fertilising products.

Formaldehyde below 1 g/kg.

1 May 2024

30 April 2039

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 hydrolysed proteins, and in particular Appendices I and II thereto, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

—

the specification of the technical material for “hydrolysed proteins-urea enriched beet molasses, hydrolysed” as commercially manufactured on the basis of an analysis of at least five representative batches.

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

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