EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards the Enterococcaceae and presuming conformity of EU fertilising products 
without verification  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
On 5 June 2019, the European Parliament and the Council adopted Regulation (EU) 
2019/1009 laying down rules on the making available on the market of EU fertilising 
products1. This Regulation repeal ed Regulation (EC) No 2003/2003 of the European 
Parliament and of the Council2 as of 16 July 2022.  
Following developments in the implementation and standardisation work in support of 
Regulation (EU) 2019/1009, a number of  technical adaptations are needed to facilitate the free 
movement of safe and efficient fertilising products in the internal market .  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Member States have been consulted in the Commission expert group on fertilising products 
(E01320) according to the rules of the Interinstitutional Agreement on Better Law -Making of 
13 April 20163 . 
Details of these consultations can be found in the minutes of the meetings held on 18-19 April 
and 27-28 November  2023 and 15 -16 April 2024 , as well as in the various position papers of 
interested stakeholders publicly available on the CIRCABC page of the group, at the 
following link:  
https://circabc.europa.eu/ui/group/36ec94c7 -575b -44dc -a6e9 -4ace02907f2f/library/b8e01334 -
4d39 -445d -bf4e-589356d55b1f   
Member  States and interested stakeholders were largely supportive of the adoption of this 
delegated Regulation.  [to fill in ] 
The draft delegated Regulation has been published for feedback on the Better Regulation 
portal [to fill in ].  
The draft delegated Regulat ion has also been notified based on Article 2(9)(2) of the 
Agreement on Technical Barriers to Trade and no comments have been received  [to be 
confirmed ].  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated act adapts to  technical progress Annexes I, II a nd III to Regulation (EU) 
2019/1009. The legal basis of this delegated act is Article 42(1) of Regulation (EU) 
2019/1009.  
                                                 
1 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, OJ L 170, 
25.6.2019, p. 1.  
2 Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 
relating to fertilisers, OJ L 304, 21.11.2003, p. 1.  
3 OJ L 123, 12.5.2016, p. 1.  
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards the Enterococcaceae and presuming conformity of EU fertilising products 
without verification  
(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 Regula tions (EC) No 1069/2009 and (EC) No 1107/2009 and 
repealing Regulation (EC) No 2003/20031, 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. Followi ng developments in the implementation of the 
Regulation and the relevant standardization work  technical adaptations to Annexes  I, 
II and III  to Regulation (EU) 2019/1009 are needed to facilitate the free movement of 
safe and agronomically efficient EU fert ilising products in the internal market.  
(2) Firstly, Annex I to Regulation (EU) 2019/1009 lays down maximum limit values for 
Enterococcaceae  for various product function categories and Annex II  to that 
Regulation  sets out limit values for the same pathogen for EU fertilising products 
containing certain component materials.  Enterococcaceae  are a family of pathogens 
often present in the environment. Out of the various genera, the most dangerous one 
from a human heal th perspective is Enterococcus . During the work performed by the 
European Committee for Standardization (CEN) to develop harmoni sed standards in 
support of th ose requirement s in Regulation (EU) 2019/1009, CEN informed the 
Commission that there are no testi ng methods to determine the content of 
Enterococcaceae , given the wide variety of bacteria concerned. The existing testing 
methods determine the content of Enterococcus . Regulation (EU) 2019/1009 should 
therefore be amended to lay down requirement s which can be tested in practice. Th at 
would facilitate the conformity assessment of the products and provide clarity both on 
the obligations of manufacturers and the way the market surveillance verifications 
should be performed.  
(3) Secondly, pursuant  to Part II, point 4 , of Annex I to Regulation (EU) 2019/1009, 
where compliance with a given requirement in Annex I (such as absence of a given 
contaminant) follows certainly and uncontestably from the nature or manufacturing 
process of an EU fertilising product, that co mpliance can be presumed in the 
conformity assessment procedure without verification (such as testing), at the 
                                                 
1 OJ L 170, 25.6.2019, p. 1 , ELI: http://data.europa.eu/eli/reg/2019/1009/oj .  
EN 3  EN responsibility of the manufacturer. A similar provision is laid down for the 
contaminant limit values in  section CMC 15 , point (6), for recovered high purity 
material s. For coherence reasons and to avoid unnecessary administrative burden, 
similar provisions should be introduced in Part II, sections CMC 3, CMC 5, CMC 12, 
CMC 13 and CMC 14  of Annex II to Regulation (EU) 2019/1009 . Those provision s 
would facilitate the conformity assessment of EU fertilising products containing such 
materials and, ultimately, their free movement in the internal market.  
(4) Thirdly, Part III of Annex III to Regulation (EU) 2019/1009 sets out to lerance  rules  
for v arious parameters to be included on the label of EU fertilising products. The 
declared value on the label may deviate from the actual value, only within the limit 
values set out by that Regulation. As regards the quantity of inorganic fertilisers, two 
tolerances are set out (1 % and 5  %). It is necessary to  identify the situations in which 
each of the two values apply. Thus, the declared quantity of inorganic macronutrient 
fertilisers should deviate only with maximum 1  %, given that such products are 
normal ly sold in larger packages or bought in bigger quantities. Inorganic 
micronutrient fertilisers are usually sold in smaller packages and therefore a 5  % 
tolerance should  be complied with.  
(5) Fourthly, Part III of Annex III to Regulation (EU) 2019/1009 sets out  a tolerance of 
0,3 percentage points  in absolute terms for the content  of inhibiting compounds 
exceeding 2  % concentration  in inhibitors , the same as the one applicable to fertilisers 
with inhibiting compounds . According to the coordination group of notified bodies  
established under Article 36 of Regulation (EU) 2019/1009 , that tolerance is very 
restrictive for inhibitors, as inhibiting compounds are usually present in big 
concentrations in such products, and not only in small concentrations as for fertili sers.  
In order to take into account manufacturing deviations and the accuracy of the 
available testing methods and thus to facilitate the conformity assessment of inhibitors, 
Regulation  (EU) 2019/1009  should be amended to introduce a more permissive 
tolerance for the content  of inhibiting compounds  in inhibitors . 
(6) Regulation (EU) 2019/1009 should therefore be amended accordingly ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2019/1009 is amended as follows:  
(1) Annex I is amended in accordance with Annex I to this Regulation;  
(2) Annex II is amended in accordance with Annex II to this Regulation;  
(3) Annex III is amended in accordance with Annex III to this Regulation.   
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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.   
EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursu la von der Le yen