Renewal of the approval of the active substance
Article 1
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.
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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
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.
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.
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.
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 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.
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