Commission Delegated Regulation (EU) 2025/1421 of 17 July 2025 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the conformity assessment procedures for EU fertilising products
Date: 2025-07-17
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, EU environmental policy, approval, fertiliser, fertiliser industry, harmonisation of standards, labelling, market approval, single market








L_202501421EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1421


10.12.2025







            COMMISSION DELEGATED REGULATION (EU) 2025/1421
of 17 July 2025
         
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the conformity assessment procedures for EU fertilising products
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (1), and in particular Article 42(1) thereof,

Whereas:







(1)


Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. An EU fertilising product may only be made available on the market if it has successfully passed the applicable conformity assessment procedure as set out in Annex IV to that Regulation.












(2)


The applicable conformity assessment procedure for ammonium nitrate fertilisers of high nitrogen content, as described in Module A1 of Annex IV, Part II, includes a detonation resistance test, and prior thermal cycles, which are to be performed by a laboratory chosen by the manufacturer and to be supervised by a notified body. Due to the explosive potential of ammonium nitrate fertilisers, it is important that the thermal cycles and detonation resistance tests results are reliable. Therefore, only laboratories that are accredited for those activities by a national accreditation body should be eligible.












(3)


The conformity assessment procedure described in Module D1 of Annex IV, Part II, of Regulation (EU) 2019/1009 requires notified bodies to carry out periodic audits. For fertilising products containing recovered component materials, the audit frequency is linked to the frequency of the output material sampling as also set out in Annex IV, which results in a high audit density for manufacturers of high tonnages, with up to 48 audits per year. To ensure proportionality of the audit requirement, the frequency of audits should be independent from the sampling frequency, and a general audit frequency of one audit per year should be set out. This will ease the conformity assessment of circular EU fertilising products containing recovered component materials without jeopardising the safety of such materials, as samples would continue to be taken with the same frequency.












(4)


In order to allow for a period of transition for manufacturers, the amendment of Module A1 should apply to thermal cycles and detonation resistance tests six months after the entry into force of this Regulation.












(5)


Therefore, Regulation (EU) 2019/1009 should be amended accordingly,





HAS ADOPTED THIS REGULATION:



Article 1
Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows:






(1)


in MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING, point 4, the following paragraph is added:

                              ‘The thermal cycles and test referred to in points 4.3 and 4.4 shall be carried out in laboratories that are accredited for those activities by a national accreditation body.’;










(2)


in MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS, point 6.3.2, the introductory statement is replaced by the following:

                              ‘For materials belonging to CMCs 3, 5, 12, 13, 14 and 15, as defined in Annex II, the notified body shall carry out annual audits. In addition, the notified body shall take and analyse output material samples with the following frequency:’.






Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 1(1) shall apply from 30 December 2025.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 July 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 170, 25.6.2019, p. 1, ELI: http://data.europa.eu/eli/reg/2019/1009/oj.


ELI: http://data.europa.eu/eli/reg_del/2025/1421/oj
ISSN 1977-0677 (electronic edition)