EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEXES 1 to 4  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION (EU) .../...  
amending Regulation  (EU)  2019/1009  of the  European  Parliament  and  of  the  
Council  as regards the requirements applicable to EU fertilising products contianing 
inhibiting compounds and the post -processing of digestate   EN 1  EN ANNEX I  
Part II of Annex I to Regulation (EU) 2019/1009 is amended as follows:  
(1) in point 2 of PFC 1(C) , the second indent  is replaced by the following:   
‘- nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 1 
in Part II of Annex II, ’; 
(2) Section ‘PFC 7 ’ is amended as follows : 
(a) the following  point  2a is inserted :  
‘2a. An inhibiting compound in a blend shall lead to th e reduction rates referred to in PFC 5 
in Part II of this Annex  and, respectively, in point 4 of CMC 1 in Part II of Annex II , at the 
level of the blend.’ , 
(b) the introductory sentence  in point 3 is replaced by the following:  
‘The manufacturer of the blend shall assess the conformity of the blend with the requirements 
set out in points 1, 2 and 2a of this PFC, ensure the blend’s compliance with the labelling 
requirements laid down in Annex III, and assume responsibility pursuant to Article 16(4) of 
this Regu lation for the compliance of the blend with the requirements of this Regulation by:’.  
   EN 2  EN ANNEX  II 
Part II of Annex II to Regulation (EU) 2019/1009 is amended as follows:  
(1) Section  ‘CMC 1 ’ is amended as follows : 
(a) point 2 is replaced by the following:   
‘2. All substances incorporated into the EU  fertilising product, on their own or in a mixture, 
except the polymers referred to in point 1(f),  shall have been registered pursuant to Regulation 
(EC) No  1907/2006, with a dossier containing:  
(a) the information pr ovided for by Annexes VI, VII and VIII to Regulation (EC) No 
1907/2006 ;  
(b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering 
the use as a fertilising product , 
unless explicitly covered by one of the registration obl igation exemptions provided for by 
Annex  IV to Regulation (EC) No  1907/2006 or by points  6, 7, 8, 9 or 10 (only for magnesia) 
of Annex  V to that Regulation.’. , 
(b) point 4 is replaced by the following:  
‘4. Where the substance or one of the substances in the mixture is intended to improve the 
EU fertilising product’s nutrient release patterns by delaying or stopping the activity of 
specific groups of micro -organisms or enzymes, that substance shall be a nitrification, a 
denitrification or a urease inhibiting c ompound, and the following rules shall apply:   
(a) The nitrification inhibiting compound shall inhibit the biological oxidation of 
ammoniacal nitrogen (NH 3-N) contained in the EU fertilising product to nitrite 
nitrogen (NO 2-), thus slowing the formation of  nitrate nitrogen (NO 3-). 
The ammoniacal nitrogen (NH 3-N) oxidation rate shall be measured by  either  of the 
following : 
(i) ammoniacal nitrogen (NH 3-N) disappearance ;  
 
(ii) the sum of nitrite nitrogen (NO 2-) and nitrate nitrogen ( NO-) production 
with respect to time .  
Compared to a control sample where the nitrification inhibiting compound has not 
been added , a soil sample containing the nitrification inhibiting compound shall show 
a 20 % reduction in ammoniacal nitrogen (NH 3-N) oxidation rate based on  an analysis 
carried out 14  days after application at the  95 % confidence level.  
The nitrification inhibiting compound shall be present in the EU fertilising product in 
a concentration that ensur es such a reduction.  
At least  50 % of the total nitrogen (N)  content of the EU  fertilising product shall 
consist of the nitrogen (N) forms ammonium (NH 4 +) and urea (CH 4N2O). 
(b) The denitrification inhibiting compound shall inhibit the formation of nitrous oxide 
(N2O) contained in the EU fertilising product by slo wing down or blocking the 
conversion of nitrate (NO 3-) to dinitrogen (N 2) without influencing the nitrification 
process as described in PFC 5(A).  
Compared to a control sample where the denitrification inhibiting compound has not 
been added, an in vitro  test containing the denitrification inhibiting compound shall EN 3  EN show a 20 % reduction in rate of the release of nitrous oxide (N 2O) based on an 
analysis carried out 14 days after application at the 95 % confidence level.  
The denitrification inhibiting compound shall be present in the EU fertilising product  
in a concentration that ensur es such a reduction.  
(c) The urease inhibiting compound shall inhibit hydrolytic action on urea (CH 4N2O) 
contained in the EU fertilising pro duct by the urease enzyme, primarily targeted to 
reduce ammonia volatilisation.  
Compared to a control sample where the urease inhibiting compound has not been 
added, an in vitro test containing the urease inhibiting compound shall show a 20 % 
reduction in  the rate of hydrolysis of urea (CH 4N2O) based on an analysis carried out 
14 days after application at the 95 % confidence level.  
The urease inhibiting compound shall be present in the EU fertilising product in a 
concentration that ensures  such a reduction . 
At least 50 % of the total nitrogen (N) content of the EU fertilising product shall 
consist of the nitrogen (N) form urea (CH 4N2O).’;  
(2) Section  ‘CMC 4 ’ is amended as follows :  
(a) the following point s 3a, 3b and 3c are inserted:  
‘3a. An EU fertilising product may contain a solid or liquid fraction of digestate, provided 
that all of the following conditions are met :  
(a) the solid or liquid fraction is obtained by mechanical separation of digestate 
compliant with points 1 to 3;  
(b)  the additives needed for the  mechanical separation comply with the 
requirement in point 1( b)(i); 
(c)  the total concentration of all additives does not exceed 5 % of the digestate 
weight.  
3b. An EU fertilising product may contain a digestate  compliant with  point s 1 to 3, or a 
fraction compliant with  point 3a, from which all or part of the soluble ammonium has been 
removed  to recover nitrogen , without the intention to otherwise modify the digestate or the 
fraction.  
3c. An EU fertilising product may contain a digestate compliant with points  1 to 3  or point 3b, 
as well as a fraction compliant with  point 3a , which  have undergone only physical  processing 
to remove water that do es not chemical ly modify the digestate or the fraction.’, 
(b) in point 4, t he introductory sentence is replaced by the following : 
‘The digestate  or a fraction referred to in  point s 3a or 3c  shall meet at least one of the 
following stability criteria:’ ; 
(3) Section ‘CMC 5 ’ is amended as follows : 
(a) the following point s 3a, 3b and 3c  are inserted:  
‘3a. An EU fertilising product may  contain a solid or liquid fraction of digestate, provided 
that all of the following conditions are met :  
(a) the solid or liquid fraction is obtained by mechanical separation of digestate 
compliant with points 1 to 3;  EN 4  EN (b)  the additives needed for the mechanical  separation comply with the 
requirement in point 1(d)(i) ; 
(c) the total concentration of all additives does not exceed 5 % of the digestate 
weight.  
3b. An EU fertilising product may contain a digestate compliant with points 1 to 3, or a 
fraction referred to in  [compliant with? See above]  point 3a, from which all or part of the 
soluble ammonium has been removed to recover nitrogen, without the intention to otherwise 
modify the digestate or the fraction.  
3c. An EU fertilising product may contain a digestate compl iant with points 1 to 3 or point 3b, 
as well as a fraction compliant with point 3a, which have undergone only physical processing 
to remove water that do not chemically modify the digestate or the fraction.’ , 
(b) point 4 is replaced by the following : 
‘4. The d igestate or the fraction referred to in point s 3a and 3c  shall not contain more than 
6 mg/kg dry matter of PAH 16.’, 
(c) in point 5, t he introductory sentence is replaced by the following : 
‘The digestate or the fraction referred to in point s 3a and 3c  shall con tain:’ , 
(d) in point 6, t he introductory sentence is replaced by the following : 
‘The digestate or the fraction referred to in point s 3a and 3c  shall meet at least one of the 
following stability criteria:’ ; 
(4) in Section ‘CMC 11 ’, point 2  is replaced by the following:  
‘2. The by -products, except the polymers referred to in point 1(b), shall have been registered 
pursuant to Regulation (EC) No  1907/2006, with a dossier containing:  
(a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) 
No 19 07/2006 ;  
(b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 
1907/2006 covering the use as a fertilising product , 
unless explicitly covered by one of the registration obligation exemptions provided for by 
Annex  IV to Regulation (EC) No  1907/2006 or by points  6, 7, 8, 9 or 10 (only for magnesia)  
of Annex  V to that Regulation.’ ; 
(5) in point 3 of Section ‘CMC 14 ’ sub-point (c) is deleted.  EN 5  EN ANNEX III 
Part II  of Annex III to Regulation (EU)  2019/1009 is amended as follows:  
(1) Section ‘PFC 1 ’ is amended as follows : 
(a) point 3 is replaced by the following:  
 
‘3. The following rules apply to fertilisers containing inhibiting compounds, as specified in 
CMC 1 in Part II of Annex II:  
(a) the label shall stat e the words ‘nitrification inhibitor’, ‘denitrification inhibitor’ 
or ‘urease inhibitor’, as relevant;  
(b) the nitrification inhibiting compound content shall be expressed as a % by mass 
of the total nitrogen (N) present as ammonium nitrogen (NH 4 +) and urea 
nitrogen (CH 4N2O); 
(c) the denitrification inhibiting compound content shall be expressed as a % by 
mass of the nitrate (NO 3-) present;  
(d) the urease inhibiting compound content shall be expressed as a % by mass of 
the total nitrogen (N) present as urea nitrogen (CH 4N2O); 
(e) The use instructions referred to in Part I, point 1(d) , of this Annex shall include 
information o n the conditions of use which could influence the efficiency of 
the inhibiting compound .’, 
(b)  in point 4(a) , point (ii) is replaced by the following:  
‘(ii) nitrification, denitrification or urease inhibiting compounds referred to in point 4 of CMC 
1 in Part II of Annex II, ’; 
(2) Section ‘PFC 5: INHIBITOR ’ is replaced by the following:  
‘PFC 5: INHIBITOR  
1. All ingredients shall be declared by product weight or volume  in descending order of 
magnitude . 
2. The content of the inhibiting compound(s) as % by mass or volume shall be declared.  
3. The use instructions referred to in Part I, point 1(d), of this Annex shall ensure that 
the inhibitor leads to the reduction rates  referred to in PFC 5 in Part II of Annex I, by 
providing information on : 
(a) the types of EU fertilising products  with which the inhibitor may be  mixed ;  
(b) the minimum and maximum recommended concentration of inhibiting 
compound(s) when mixed with a fertiliser prior to its use:  
(i) for the nitrification inhibitor referred to in PFC 5(A) in Part II of 
Annex I , as a % by mass of the total nitrogen (N) present as 
ammonium nitrogen (NH 4 +) and urea nitrogen (CH 4N2O); 
(ii) for the denitrification inhibitor referred to in PFC 5(B) in Part II of 
Annex I, as a % by mass of the nitrate (NO 3-) present;  
(iii) for the urease inhibitor referred to in PFC 5(C) in Part II of Annex 
I, as a % by mass of the total nitrogen (N) pr esent as urea nitrogen 
(CH4N2O);  EN 6  EN (c) the conditions  of use which could affect the efficiency of the inhibitor .’ 
 
In Part III  of Annex III , Section ‘PFC 1 : FERTILISER’ is replaced by the following:  
‘PFC 1: FERTILISER  
The following tolerance rules apply to fertilisers containing nitrification, denitrification or  
urease inhibiting compounds, as specified in CMC  1 in Part II of Annex  II: 
Inhibiting compounds  Permissible tolerance for the declared content of 
inhibiting compounds  
Concentration below or equal 
to 2 % ± 20 % of the declared value  
Concentration of more  than 
2 % ± 0,3 percentage points in absolute terms’  
   EN 7  EN ANNEX IV  
Part I  of Annex IV to Regulation (EU) 2019/1009 is amended as follows:  
(1) point 1.1  is amended as follows : 
(a) sub-point (a) is replaced by the following:  
‘(a) virgin material substances or mixtures as specified in CMC 1 in Part II of Annex II, 
except a nitrification, a denitrification or a urease inhibiting compound ,’, 
(b) sub-point (d) is deleted. ;  
(2) in point 3.1 , sub -point (a) is replaced by the following:  
‘(a) nitrification, denitrification or urease inhibit ing compound  as specified in CMC 1 in Part 
II of Annex II,’.