EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
ANNEXES 1 to 4  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION  
amending, for the purpose of adaptation to technical progress, Annexes I, II, III and IV 
to Regulation (EU) 2019/1009 of the European Parliament and of the Council laying 
down rules on the making available on the market of EU fertilising products   EN 0  EN  
ANNEX  I 
 
Part II of Annex I to Regulation  (EU)  2019/1009  is amended as follows:  
(1) point 5 is replaced by the following:  
‘5.  Residue s of a pharmacologically active substance within the meaning of Regulation 
(EC) No 470/2009  of the European Parliament and of the Council * may be present in an EU 
fertilising product only if that substance is either :  
– included in Table 1 of the Anne x to Commission Regulation (EU) No 37/2010 **, or  
– has had a reference point for action established in accordance with Commission 
Regulation (EU) 2019/1871 ***, and the substance  or its residues  are present  in the 
EU fertilising product at a level below that refe rence point. ’; 
(2) the following  point  5a is inserted:  
‘5a.  An EU fertilising product shall not contain an active substance within the meaning of 
Article 2(2) of Regulation (EC) No  1107/2009 giving the product a plant protection function 
within the meaning of  Article 2(1) of that Regulation. ’; 
(3) in the tabl e in point 2 in PFC 1(C)(II)(a), the row concerning  the typology  
‘Micronutrient salt fertiliser’  is replaced by the following:  
‘Micronutrient salt fertiliser  A chemically obtained 
straight solid inorganic 
micronutrient fertiliser 
containing a mineral ion salt 
as its essential ingredient  10 % by mass of micronutrient salt 
fertiliser shall consist of a 
micronu trient’   
 
(4) in PFC 3(B), the following point 3a is added:  
‘3a.  Pathogens in an inorganic soil improver  that contains more than 1 % by mass of 
organic carbon (C org) must not exceed the limits set out in the following table:  
 
Micro -organisms to be tested  Sampling plans  Limit  
n c m M 
Salmonella  spp. 5 0 0 Absence in 25  g or 
25 ml 
Escherichia coli  or 
Enterococcaceae   5 5 0 1 000 in 1  g or 
1 ml 
Where:  EN 1  EN n =  number of samples to be tested,  
c =  number of samples  where the number of bacteria expressed in CFU is between m and  M, 
m  =   threshold value for the number of bacteria expressed in CFU that is considered 
satisfactory,  
M =   maximum value of the number of bacteria expressed in CFU. ’; 
(5) in PFC 4 , the following  point 2a is inserted:  
‘2a.  By derogation from point 2 (d), the limit value for nickel  (Ni) in a growing medium 
totally composed by mineral constituents  and offered for professional use in horticultur e, 
green roofs or green walls, shall apply to the bioavailable content of the contaminant. ’.  
 
* Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 
2009 laying down  Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council 
Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Counc il and Regulation (EC) No 726/2004 of the European Parliament 
and of the Council (OJ L 152, 16.6.2009, p. 11).  
** Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically 
active substances and their classification regarding maximum re sidue limits in foodstuffs of 
animal origin (OJ L 15, 20.1.2010, p. 1).  
*** Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for 
action for non -allowed pharmacologically active substances present in food of animal origin 
and repe aling Decision 2005/34/EC (OJ L 289, 8.11.2019, p. 41).  
  EN 2  EN  
 
ANNEX  II 
 
Part II of Annex II to Regulation (EU) 2019/1009 is amended as follows:  
(1) CMC 1  is amended as follows:  
(a) sub-point (f) of point 1 is replaced by the following : 
 ‘(f)  polymers, other than :  
– polymers that are the result of a polymerisation process that has taken place in 
nature, independently of the extraction process with which they have been extracted 
and that have not been chemically modified within the meaning of Article 3(40) of 
Regulatio n (EC) No 1907/2006,  
– biodegradable polymers , or 
– polymers with a solubility higher than 2 g/L in the following conditions:  
– temperature 20⁰  C  
– pH 7  
– loading: 10  g/1000  mL  
– test time: 24h ,’;  
(b) in point 3 (a), the last sentence is replaced by  the following : 
‘The EU fertilising product shall remain stable for at least 3 days in a solution having any pH 
within the range declared  as guaranteeing  acceptable stability .’;  
(2) in CMC 2, the first paragraph is replaced by the following:  
‘An EU fertilising  product may con tain plants, plant parts or plant extracts having undergone 
no processing  other  than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, 
drying, frost treatment, freeze -drying , extraction with water , supercritical CO 2 extraction , or 
fiberisation at a temperature not higher than 100  °C and without any additives except water .’; 
(3) CMC 3  is amended as follows:  
(a) point 1(b) is deleted;  
(b) point 1( c) is replaced by the following:  
‘(c) living or dead organisms or parts thereof, which are unprocessed or processed only by 
manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction 
with water, by steam distillation or by heating solely to remove water, or which are extracted 
from air by any means, except:  
(i) materials  originating from mixed municipal waste, ’; 
(ii) sewage sludge, industrial sludge or dredging sludge, and  
(iii) animal by -products or derived products within the scope of Regulation (EC) No 
1069/2009.’ ; 
(c) in point 1(e), the introductory wording is replaced by  the following:  
‘(e) any material listed in points (a) or (c) or in point 1 a which:’;  EN 3  EN (d) the following  point 1a is inserted:  
‘1a. Notwithstanding point 1, an EU fertilising product may contain compost obtained 
through aerobic composting of Category 2 or Category 3 materials or derived products 
thereof, in accordance with the conditions set out in Article 32(1) and (2) and in the measures 
referred to in Article 32(3) of Regulation (EC) No 1069/2009, alone or mixed with input 
materials referred to in point 1, provided that:  
(a) the end point in the manufacturing chain has been determined in accordance 
with the third subparagraph of Article 5(2) of Regulation (EC) No 1069/2009, 
and 
(b) the conditions in points 2 and 3 are met. ’; 
(e) point 2(a) is replaced by the followin g: 
‘(a) in which production lines for the processing of input materials referred to in points 1 and 
1a are clearly separated from production lines for the processing of input materials other than 
those referred to in points 1 and  1a, and’;  
 
(4) CMC 5  is amende d as follows:   
(a) point 1(b) is deleted;  
(b) point 1(c) is replaced by the following:  
‘(c) living or dead organisms or parts thereof which are unprocessed or processed only by 
manual, mechanical or gravitational means, by dissolution in water, by flotation, by ex traction 
with water, by steam distillation or by heating solely to remove water, or which are extracted 
from air by any means, except:  
  (i) materials originati ng from mixed municipal waste, ’; 
(ii) sewage sludge, industrial sludge or dredging sludge,  
(iii) animal by -products or derived products within the scope of Regulation (EC) No 
1069/2009.’;  
(c) in point 1(e), the introductory wording is replaced by the following:  
‘(e) any material listed in points (a) or (c) or in point 1a which:’;  
(d) the following point 1a is inserted:  
‘1a. Notwithstanding point 1, an EU fertilising product may contain digestate obtained 
through anaerobic digestion of Category 2 or Category 3 materials or derived products 
thereof, in accordance with the conditions set out in Article 32(1) an d (2) and in the measures 
referred to in Article 32(3) of Regulation (EC) No 1069/2009, alone or mixed with input 
materials referred to in point 1, provided that:  
(a) the end point in the manufacturing chain has been determined in accordance 
with the third sub paragraph of Article 5(2) of Regulation (EC) No 1069/2009, 
and 
(b) the conditions in points 2 and 3 are met.’;  
(e) point 2(a) is replaced by the following:  EN 4  EN ‘(a) in which production lines for the processing of input materials referred to in points 1 and 
1a are clea rly separated from production lines for the processing of input materials other than 
those referred to in points 1 and 1a, and’;  
(5) in CMC 11, sub -point (b) of  point 1 is replaced by the following:  
 ‘(b) polymers, other than:  
– polymers that are the result of a polymerisation process that has taken place in  
nature, independently of the extraction process with which they have been extracted 
and that have not been chemically modified within the meaning of Article 3(40) of 
Regulation (EC) No 1907/2006,  
– biodegradab le polymers , or  
– polymers with a solubility higher than 2 g/L in the following conditions:  
– temperature 20⁰  C  
– pH 7  
– loading: 10  g/1000  mL  
– test time: 24h ,’.  EN 5  EN ANNEX  III 
 
Annex III to Regulation (EU) 2019/1009  is amended as follows:  
(1) Part I is amended as follows:  
(a) point 1(h) is replaced by the following:  
‘(h)  a list of all ingredients above 5 % by product weight or volume , or in the case of 
products in liquid form by dry weight, in descending order of magnitude, including the 
designations of the relevant CMCs as referred to in Part I of Annex II to this Regulation. 
Where the ingredient is a substance or a mixture, it shall be identified in accordance with  
Article 18 of Regulation (EC) No 1272/2008. N aturally occurring substances may be 
identified by their mineral names. ’; 
(b) point 3 is  replaced by the following:   
‘3.  Where the EU fertilising product  contains a component material which,  if placed on 
the market as food or feed, would have been subject to  maximum residue limits established 
pursuant  to Regulation (EC) No 470/2009  or Regulation (EU) No 1831/2003 of the European 
Parliament and of the Council *, maximum residue levels set in accordance with Regulation 
(EC) No 396/2005  of the European Parliament and of the Council **, or maximum levels 
established pursuant to Council Regulation (E EC) 315/93 *** or Directive 2002/32/EC  of the 
European Parliament and of the Council **** , and which contains a substance in exceedance  
of (one of) the corresponding  limit value (s), the maximum concentration of that substance in 
the EU fertilising product shall be indicated, together with a warning that the EU fertilising 
product must not be used in such a manner as to risk leading to the exceedance of th at limit in 
food or feed. ’;  
(c) point 7 is replaced by the following:  
 ‘7. Where the EU fertilising product is a growing medium as referred  to in point 2a of PFC 4 
in Part II of Annex I , or contains a polymer with the purpose of binding material in the 
product as referred  to in point 1(c) of CMC 9 in Part II of Annex II, the user shall be 
instructed not to use the product in contact with soil, and in collaboration with the 
manufacturer, to make sure of a sound disposal of the product after end of use.’;  
(2) Part II is amended as follows:  
(a) in point 5 in PFC 1(B):   
(1) sub-point (a) is replaced by the following:  
 ‘(a) indication of the names and chemical symbols of the declared micronutrients, listed in 
the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), 
molybdenum (Mo) and zinc (Zn), followed by the names of their counter -ions when the 
declared micro nutrients  are intentionally added ;’; 
(2) sub-point (c) is replaced by the following:  
 ‘(c) where the declared micronutrients are chelated by chelating agent(s) or complexed by 
complexing agent(s) :  
– the following qualifier as applicable,  after the name and chemical identifier of the 
micronutrient:  
‘chelated by [name of the chelating agent(s) or its(their) abbreviation]’ / ‘complexed by [name 
of the complexing agent(s) or its(their) abbreviation]’ / ‘chelated by [name of the chelating EN 6  EN agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its 
(their) abbreviation]’;  
– the amount of chelated/complexed micronutrient(s) as % by mass ;’; 
(3) the following  sub-point (ca) is inserted:  
‘(ca)  where the declared micronutrients  are chelated by chelating agent(s),  the pH range 
guaranteeing acceptable stability;’;   
(4) sub-point (d) is deleted;  
(b) in PFC 1(C)(I)(a):  
(1) point 3  is replaced by the following : 
‘3. The form of the physical unit of the product shall be indicated with one, or a combination 
of two or more, of the following mentions:  
(a) granules,  
(b) pellets,  
(c) powder, where at least 90 % by mass of the product can pass through a sieve with a 
mesh of  1 mm,  
(d) prills, or   
(e) a combination of two or more of the above -mentioned forms .’; 
(2) in point 8:  
(a) sub-point (a) is replaced by the following:  
‘(a) indication of the names and chemical symbols of the declared micronutrients, listed in the 
following order : boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), 
molybdenum (Mo) and zinc (Zn), followed by the names of their counter -ions when the 
declared micronutrients  are intentionally added;’;  
(b) sub-point ( c) is replaced by the following:  
‘(c) where the declared micronutrients are chelated by chelating agent(s) or complexed by 
complexing agent(s) :  
– the following qualifier , as applicable,  after the name and chemical identifier of the 
micronutrient:  
‘chelated by [name of the chelating agent(s) or its(th eir) abbreviation]’ / ‘complexed by [name 
of the complexing agent(s) or its(their) abbreviation]’ / ‘chelated by [name of the chelating 
agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its 
(their) abbreviation]’;  
– the amount of chelated/complexed micronutrient(s) as % by mass;’;  
(c) the following  sub-point  (ca) is inserted:  
 ‘(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range 
guaranteeing acceptable stability;’;  
(d) sub-point ( d) is deleted;  
(c) in point 6 in PFC 1(C)(I)(b):  
(1) sub-point (a) is replaced by the following:  EN 7  EN ‘(a) indication of the names and chemical symbols of the declared micronutrients, listed in the 
following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (M n), 
molybdenum (Mo) and zinc (Zn), followed by the names of their counter -ions when the  
declared micronutrients  are intentionally added ;’; 
(2) sub-point (c) is replaced by the following:  
‘(c) where the declared micronutrients are chelated by chelating agent(s)  or complexed by 
complexing agent(s) :  
– the following qualifier , as applicable,  after the name and chemical identifier of the 
micronutrient :  
‘chelated by [name of the chelating agent(s) or its(their) abbreviation]’ / ‘complexed by [name 
of the complexing a gent(s) or its(their) abbreviation]’ / ‘chelated by [name of the chelating 
agent(s) or its(their) abbreviation] and complexed by [name of the complexing agent(s) or its 
(their) abbreviation]’;  
– the amount of chelated/complexed micronutrient(s) as % by mass; ’; 
(3) the following sub-point  (ca) is inserted:  
‘(ca) where the declared micronutrients are chelated by chelating agent(s), the pH range 
guaranteeing acceptable stability;’;  
(4) sub-point (d) is deleted;  
(d) in PFC 1(C)(II) :  
(1) point 1 is replaced by the following:  
‘1. The declared micronutrients in the inorganic micronutrient fertiliser shall be listed by their  
names and chemical symbols of the declared micronutrients, in the following order: boron 
(B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), 
followed by the names of their counter -ions when the declared micronutrients  are 
intentionally added .’; 
(2) point 2 is replaced by the following:  
 ‘2. Where the declared micronutrients are chelated by chelating agent(s) and each chelating 
agent can be identified and quantified and chelates at least 1% water -soluble micronutrient , or 
the declared micronutrients are complexed by complexing agent(s ), the following qualifiers 
shall be added , as applicable,  after the name and chemical identifier of the micronutrient:  
– ‘chelated by [name of the chelating agent(s) or its(their) abbreviation]’ / ‘complexed 
by [name of the complexing agent(s) or its(their) abbreviation]’ / ‘chelated by [name 
of the chelating agent(s) or its(their) abbreviation] and com plexed by [name of the 
complexing agent(s) or its (their) abbreviation ]’,  
– the amount of chelated/complexed micronutrient(s) as % by mass;’ ; 
(3) the following  point 2a is inserted:  
‘2a. Where the declared micronutrients are chelated by chelating agent(s), the pH range 
guaranteeing acceptable stability shall be indicated.’;  
(4) point 3 is deleted ; 
(3) Part III is amended as follows:  
(a) in PFC 1(C):  EN 8  EN (1) the first table is replaced by the following:  
 ‘Forms of the declared nutrient and 
other declared parameters  
 Permissible tolerance for the declared 
macronutrient content and other declared 
parameters  
Declared forms of nitrogen (N)  ±   25 % relative deviation of the declared 
value up to a maximum of  2 percentage 
points in absolute terms  
Declared forms of phosphorus pentoxide 
(P2O5) ±  25 % relative deviation of the declared 
value up to a maximum of 2 percentage 
points in absolute terms  
Declared forms of potassium oxide (K 2O) ±  25 % relative deviation of the declared 
value up to a maximum of 2 percentage 
points in absolute terms  
Declared forms of nitrogen (N), phosphorus 
pentoxide (P2O5) or potassium oxide (K2O) 
in binary fertilisers  ± 1,5 percentage points in absolute terms  
Declared forms of nitrogen (N), phosphorus 
pentoxide (P2O5) or potassium oxide (K2O) 
in tertiary fertilisers  ± 1,9 percentage points in absolute terms  
Total and water -soluble magnesium oxide 
(MgO), calcium oxide (CaO), sulphur 
trioxide (SO 3)  -50 and +1 00 % relative deviation of the 
declared content of those nutrients up to a 
maximum of  -2 and + 4 percentage points 
in absolute terms  
Total and water soluble sodium oxide 
(Na 2O) – 25 % of the declared content up to a 
maximum of 0,9 percentage point in 
absolute terms + 50 % of the declared 
content up to a maximum of 1,8 percentage 
points in absolute terms  
Granulometry  ±  20 % relative deviation of the declared 
percentage of material passing a specific 
sieve  
Quantity  ± 1 % relative deviation of the declared 
value ’ 
(2) the second table is replaced by the following:  
‘Micronutrient  Permissible tolerance for the declared content 
of forms of micronutrient  
Concentration below or equal to 2  % ± 50 % of the declared value  EN 9  EN Concentration of more than 2  % and below 
or equal to 10  % ± 50 % of the declared value up to a maximum of 
1,0 percentage point in absolute terms  
Concentration of more than 10  % ± 1,0 percentage point in absolute terms ’ 
 
(b) in PFC 3 , the second row which sets out  the tolerance for organic carbon is replaced 
by the following:  
 ‘Organic carbon (C org) ± 10 % relative deviation of the dec lared value up to 
a maximum of 3 ,0 percentage point s in absolute 
terms ’ 
 
(c) the following  section is inserted  after ‘PFC 5: INHIBITOR ’: 
 ‘PFC 6: PLANT BIOSTIMULANT  
The quantity of a plant biostimulant may deviate by  ± 5 %.from the declared value.’ ; 
(d) at the beginning of  PFC 7, the following  table  is inserted : 
 
Declared parameter  Permissible tolerance for the declared 
parameter  
Quantity  the tolerance is the sum of the relative proportion of 
each component EU fertilising product multiplied 
by the tolerance for the PFC for that fertilising 
product. If the proportion of each EU fertilising 
product in the fertilising product blend cannot be 
determined, the tolerance is that of the PFC with 
the strictest quantity tolerance value.  
 
* Regulation (EC) No 1831/ 2003 of the European Parliament and of the Council of 22 
September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).  
 ** Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 
February 2005 on maximum residue levels of pesticides in or on food and feed of plant and 
animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005,  p. 1). 
*** Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community 
procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1). 
****  Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on 
undesirable sub stances in animal feed (OJ L 140, 30.5.2002, p. 10). 
 EN 10  EN ANNEX  IV 
 
Annex I V to Regulation 2019/1009/EU is amended as follows:  
(1) in Part I, point 3.2 is replaced by the following:  
‘3.2 Module B followed by Module C may also be used for a f ertilising produ ct blend as 
specified in PFC 7.’ ; 
(2) Part II is amended as follows:  
(a) in Module A, in point 2.2 :  
(1) sub-point (g) is replaced by the following:  
‘(g) results of calculations made, examinations carried out, etc., ’; 
(2) sub-point (j) is replaced  by the following:  
 ‘(j) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg  dry 
matter , information about the maximum quantity and exact source of total chromium (Cr). ’; 
(b) in Module A1, sub-point 2.2(h) is replaced by the following:  
‘(h) results of calculations made, examinations carried out, etc.,’ ; 
(c) in Module B, in point 2.2:   
(1) sub-point (g) is replaced by the following:  
‘(g) results of calculations made, examinations carried out, etc.,’ ; 
(2) sub-point (k) is replaced by the following:  
‘(k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg  dry 
matter , information about the maximum quantity and exact source of total chromium (Cr). ’; 
(d) in Module D1, in point 2.2:   
(1) sub-point (g) is replaced by the following:  
‘(g) results of calculations made, examinations carried out, etc.,’ ; 
(2) sub-point (k) is replaced by the following:  
‘(k) where the EU fertilising product contains total chromium (Cr) above 200 mg/kg  dry 
matter , information about the maxim um quantity and exact source of total chromium (Cr). ’.EN 11  EN