Date: 2025-12-10Category: Not ApplicableState: Union GovernmentCountry: Europe
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
**Executive Summary**
This is a summary of Commission Delegated Regulation (EU) 2025/1421 of 17 July 2025, which amends Regulation (EU) 2019/1009 regarding conformity assessment procedures for EU fertilising products. This regulation mandates accredited laboratories for thermal cycles and detonation resistance tests and adjusts audit frequency for certain recovered component materials. Article 1(1) concerning accredited laboratories for thermal cycles and detonation resistance tests, applies from 30 December 2025.
**Key Points / Main Content**
* **Ammonium Nitrate Fertilisers (Module A1):**
* Thermal cycles and detonation resistance tests for ammonium nitrate fertilisers must be conducted in laboratories accredited by a national accreditation body.
* This requirement applies six months after the regulation's entry into force (applies from 30 December 2025).
* **Recovered Component Materials (Module D1):**
* For fertilising products containing recovered component materials belonging to CMCs 3, 5, 12, 13, 14 and 15 the notified body shall carry out annual audits.
* The frequency of audits for these products will be once per year, independent of sampling frequency.
* **Entry into Force:**
* The Regulation enters into force on the twentieth day following its publication in the Official Journal of the European Union.
* Article 1(1) applies from 30 December 2025.
**Impact Analysis**
**Manufacturers of Ammonium Nitrate Fertilisers**
* **Impact:** Manufacturers must use accredited laboratories for thermal cycles and detonation resistance tests.
* **Action Required:** Identify and contract with accredited laboratories by December 30, 2025, to ensure compliance with the new testing requirements.
**Manufacturers of Fertilising Products Containing Recovered Component Materials belonging to CMCs 3, 5, 12, 13, 14 and 15**
* **Impact:** Conformity assessment procedures are eased due to the reduced and predictable audit frequency.
* **Action Required:** Understand and adhere to the new annual audit frequency.
**Notified Bodies**
* **Impact:** Notified bodies must ensure that thermal cycles and detonation resistance tests are carried out in accredited laboratories and implement the new annual audit schedule for products containing recovered component materials.
* **Action Required:** Update procedures to verify laboratory accreditation and adjust audit schedules to reflect the annual audit requirement.
Key Entities Referenced
Regulation (EU) 2019/1009: Regulation of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products.
Commission Delegated Regulation (EU) 2025/1421: Amends Regulation (EU) 2019/1009 regarding conformity assessment procedures for EU fertilising products.
Annex IV: Annex to Regulation (EU) 2019/1009, setting out conformity assessment procedures.
European Parliament: Co-legislator with the Council of the European Union.
Council of the European Union: Co-legislator with the European Parliament.
Official Journal EN
of the European Union 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.’;
(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 1/2EN
OJ L, 10.12.2025
(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
2/2 ELI: http://data.europa.eu/eli/reg_del/2025/1421/oj