Commission Implementing Regulation (EU) 2024/839 of 8 March 2024 renewing the approval of the low-risk active substance urea 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

Renewal of the approval of the active substance

Article 1

The approval of the active substance urea, 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

Article 2

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

Article 3

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 ISupplementary provisions

ANNEX I Common Name, Identification Numbers IUPAC Name Purity  ( 1 ) Date of approval Expiration of approval Specific provisions Urea CAS No: 57-13-6 CIPAC No: 913 Urea 980 g/kg The following impurities were considered of toxicological concern and a maximum level is established of:   Biuret: < 12 g/kg   Formaldehyde: < 0,5 g/kg   Cadmium: < 1 mg/kg   Mercury: < 0,1 mg/kg   Lead: < 1 mg/kg   Arsenic: < 1 mg/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 urea, 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 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 IISupplementary provisions

ANNEX II The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in Part A, entry 257 on urea 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 ‘48 Urea CAS No: 57-13-6 CIPAC No: 913 Urea 980 g/kg The following impurities were considered of toxicological concern and a maximum level is established of:   Biuret: < 12 g/kg   Formaldehyde: < 0,5 g/kg   Cadmium: < 1 mg/kg   Mercury: < 0,1 mg/kg   Lead: < 1 mg/kg   Arsenic: < 1 mg/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 urea, 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 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.