EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft 
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION DELEGATED REGULATION  
amending Annexes II and IV to Regulation (EU) 2019/1009 of the European Parliament 
and of the Council for the purpose of adding precipitated phosphate salts and derivates 
as a component material category in EU fertilising products  
 
  EN 1  EN ANNEX  I 
Annex II to Regulation (EU) 2019/1009  is amended as follows:  
(1) In Part I, the following point is added:  
"CMC 12 : Precipitated phosphate salts and derivates" . 
(2) Part II is amended as follows:  
(a)  Point 1 of CMC 1  is amended as follows :  
– in sub-point (g), “or” is deleted;  
– in sub-point (h), “.” is replaced by “, or”; 
– the following  sub-point (i) is added:  
“(i) precipitated phosphate salts or derivates  from recovered waste or by -products within the 
meaning of Directive 2008/98/EC ,”. 
(b) Point 1 of CMC 11  is amended as follows : 
– in sub-point (c), “or” is deleted;  
– in sub-point (d), “.” is replaced by “, or”; 
– the following  sub-point (e) is added:  
“(e)  precipitated phosphate salts or derivates  from recovered waste or by -products within 
the meaning of Directive 2008/98/EC .”. 
(c) The following CMC  12 is added:  
"CMC 12: PRECIPITATED PHOSPHATE SALTS AND  DERIVATES  
1. An EU fertilising product may contain precipitate d phosphate salts obtained through 
precipitation exclusively from one or more of the following input materials:  
(a) wastewaters and sewage sludge from municipal wastewater treatment plants , 
other than animal by -products or derived products within the scope of 
Regulation (EC) No 1069/2009;  
(b) wastewaters from processing of foods, beverages, pet foods, anim al feeds, or 
dairy products, other than animal by -products or derived products within the 
scope of Regulation (EC) No 1069/2009 , unless processing steps involved 
contact with biocidal products within the meaning of point (a) of Article 3(1) 
of Regulation (EU) No 528/2012 of the European Parliament and of the 
Council (*) other than those defined as product -type 4 of main group 1 of 
Annex V to that Regulation ;  
(c) bio-waste within the meaning of point 4 of Article 3 of Directive 2008/98/EC 
resulting from separate bio -waste collection at source, other than animal by -
products or derived products within the scope  of Regulation (EC) No 
1069/2009 ; 
(d) processing residues within t he meaning of point (t) of Article 2 of Directive 
2009/28/EC of the European Parliament and of the Council (**) from the 
production of bioethanol and biodiesel derived from materials referred to in 
sub-points (b), (c) and (e) of this point;  
(e) living or dead organisms or parts thereof, which are unprocessed or processed 
only by manual, mechanical or gravitational means, dissolution in water, EN 2  EN flotation,  extraction with water,  steam distillation or heating solely to remove 
water, or which are extracted from ai r by any means, except  (***) : 
– materials originating from mixed municipal waste,  
– sewage sludge, industrial sludge or dredging sludge,  
– animal by -products or derived products within the scope  of Regulation 
(EC) No 1069/2009 ; 
(f) substances and mixtures, other tha n (***) : 
– those referred to  in sub -points (a) to ( e), 
– waste within the meaning of point 1 of Article 3 of Directive 
2008/98/EC,  
– substances or mixtures which have ceased to be waste in one or more 
Member States by virtue of the national measures transposing Article 6 
of Directive 2008/98/EC,  
– substances formed from precursors which have ceased to be waste in one 
or more Member States by virtue of the national measures transposing 
Article 6 of Directive 2008/98/EC, or mixtures containing such 
substances,  
– non-biodegradable polymers,  
– animal by -products or derived products within the scope of Regulation 
(EC) No 1069/2009.  
In addition, precipitated phosphate salts shall be obtained through precipitation from 
any input material referred to  in sub-points (a)  to (f), or a combination thereof, 
processed by manual, mechanical or gravitational means, solid -liquid fractionation 
using biodegradable polymers, dissolution in water, flotation, extraction with water, 
steam distillation or heating solely to remove water, therma l hydrolysis, anaerobic 
digestion or composting. The temperature under  such processes shall not be raised 
above 275°C.  
2. The precipitation process shall take place under controlled conditions in a reactor. In 
addition, only input materials, which are not con taminated with other material 
streams, or input materials , other than animal by -products or derived products within 
the scope of Regulation (EC) No 1069/2009 , which have been unintentionally 
contaminated with other material streams in a one -off incident re sulting only in trace 
levels of exogenous compounds shall be used.  
In the plant where the precipitation takes place , physical contacts between input and 
output materials shall be  avoided  after the precipitation process , including during 
storage.  
3. The precipitated phosphate salts shall contain:  
(a) a minimum phosphorus pentoxide ( P2O5) content of 16  % of the dry matter 
content;  
(b) a maximum organic carbon  (Corg) content of 3  % of the dry matter content;  
(c) no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any 
of the following forms: organic matter , glass, stones, metal and plastics;  EN 3  EN (d) no more than 5 g/kg dry matter of the sum of the macroscopic impurities 
referred to in sub-point (c ).  
4. An EU fertilising product may contain derivates fro m precipi tated phosphate salts 
produced through one or more chemical manufacturing steps that react the 
precipitated phosphate salts with materials referred to  in sub-point 1(f) that are 
consumed in or used for chemical processing.   
The derivate manufacturing proce ss shall be executed so as to intentionally modify 
the chemical composition of the precipitated phosphate salts.  
5. The precipitated phosphate salts used for the derivates shall comply with points 1 to 
3.  
6. Notwithstanding point 1, an EU fertilising product ma y contain precipitated 
phosphate salts obtained through precipitation from 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) o f 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 1069/200 9, 
and 
(b) the conditions in points 2 and 3 are met.  
An EU fertilising product may also contain derivates from such precipitated 
phosphate salts, obtained in accordance with the conditions set out in point 4.  
7. In the plant where the precipitation takes place, the production lines for the 
processing of input materials allowed for the precipitated phosphate salts and 
derivates referred to in points 1, 4 and 6 shall be clearly separated from production 
lines for th e processing of  other  input materials.   
8. Whe re for the PFC of  an EU fertilising product containing or consisting of 
precipitated  phosphate salts  or derivates or both there are no requirements regarding 
Salmonella  spp., Escherichia  coli or Enterococcaceae  in Annex I , these  pathogens 
shall  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:  
n = number of samples to be tested,   
c = number of samples where the number of bacteria expressed in CFU is between m 
and M,  EN 4  EN 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.  
9. Pathogens in an EU fertilising product containing or consisting of precipitated 
phosphate salts obtained  from materials referred to  in sub-point 1( a) or derivates 
from such precipitated phosphate salts or both shall not exceed the limits set out in 
the following table:  
Micro -organisms to be tested  Sampling plans  Limit  
n c m M 
Clostridium perfringens  5 5 0 100 CFU in 1 g or 1 ml  
Ascaris  sp. eggs 5 0 0 Absence in 25  g or 25  ml 
Where:  
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 . 
10. The requirements set out in points  (8) and (9), as well as the requirements for 
Salmonella  spp., Escherichia coli  or Enterococcaceae  set in the corresponding PFC 
of an EU fertilising product consisting only of precipitated phosphate salts  or 
derivates  or both shall not apply when those precipitat ed phosphate salts or all of the 
biogenic input materials used in the precipitation process have undergone  one of the 
following processes:  
(a) pressure sterilisation through the heating to a core temperature of more  than 
133°C for at least 20 minutes at a n absolute pressure  of at least 3 bars , whereby 
the pressure must be produced by the evacuation of all air in the sterilisation 
chamber and the replacement of the air by steam (‘saturated steam’);  
(b) processing in a pas teurisation or hygienisation unit that reaches a temperature 
of 70  °C for at least one hour.  
11. Precipitated phosphate salts obtained from materials referred to  in sub-point 1(a) and 
derivates obtained from such precipitated phosphate salts shall have no more  than 6 
mg/kg dry matter of PAH 16 (****)  
12. The sum of aluminium (Al) and iron (Fe) in precipitated phosphate salts or derivates 
shall not exceed 10% of the dry matter of the precipitated phosphate salts  or the 
derivates .  
13. Precipitated phosphate salts or derivates 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 of Regulation (EC) 
No 1907/2006; and;  EN 5  EN (b) a chemical safety report pursuant to Article 14 of Regulatio n (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, or 9 of 
Annex V to that Regulation.  
14. For the purposes of points 3, 11 and 12, the dry matter of precipitated phosphate salts 
and derivates shall be measured using vacuum drying at 40°C until constant weight 
to avoid the loss of crystal -bound water . 
 
* Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 
May 2012 concerning the making available on the market and use of biocidal products (OJ L 
167, 27.6.2012, p. 1).  
** Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 
on the prom otion of the use of energy from renewable sources and amending and 
subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140 5.6.2009, p. 16) . 
*** The exclusion of a n input  material from a sub-point does not prevent it from being an 
eligible  input material by virtue of another sub -point . 
**** Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, 
anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, 
benzo[k]fluoranthene, benzo[a]pyrene, indeno[1 ,2,3-cd]pyrene, dibenzo[a,h]anthracene and 
benzo[ghi]perylene. ”. 
 EN 6  EN ANNEX II 
Module D1 (Quality assurance of the production process ) in Part II of Annex IV to Regulation 
(EU) No 2019 /1009  is amended a s follows:  
(1) In point 2.2 , sub-point (d) is replaced by the following:  
“(d) drawings, schemes, descriptions and explanations necessary for the understanding of 
the manufacturing process of the EU fertilising product, and, in relation to materials 
belonging to CMCs 3 , 5 and 12  as defined in Annex II, a written description and a diagram of 
the production process, where each treatment, storage vessel and area is clearly identified,”.  
(2) The introductory wording  in point 5.1.1.1 is replaced by the following:  
“5.1.1 .1. For materials belonging to CMCs 3 , 5 and 12, as defined in Annex II, senior 
management of the manufacturer's organisation shall:” . 
(3) Point 5.1.2.1  is replaced by the following : 
“5.1.2.1. For materials belonging to CMCs 3, 5 and 12, as defined in Annex II , the quality 
system shall ensure compliance with the requirements specified in that Annex.” . 
(4) Point 5.1.3.1 is amended as follows:  
(a) The introductory wording  is replaced by the following:  
“5.1.3.1. For materials belonging to CMCs 3 , 5 and 12, as defined in A nnex II, the 
examinations and tests shall comprise the following elements:” . 
(b) Sub-point s (b) and (c) are  replaced by the following:  
“(b) Qualified staff shall carry out a visual inspection of each consignment of input materials 
and verify compatibility with  the specifications of input materials in CMCs 3, 5 and 12 laid 
down in Annex II.  
(c) The manufacturer shall refuse any consignment of any given input material where visual 
inspection raises any suspicion of  any of the following:   
– the presence of hazardous  or damageable substances for the process or for the quality 
of the final EU fertilising product ;  
– incompatibility with the specifications of CMCs 3, 5 and 12 in Annex II, in particular 
by presence of plastics leading to exceedance of the limit value for m acroscopic 
impurities.”.  
(c) Sub-point (e) is replaced by the following:  
“(e) Samples shall be taken on output materials, to verify that they comply with the 
specifications laid down in CMCs 3, 5 and 12, as defined in Annex II, and that the properties 
of the o utput material do not jeopardise the EU fertilising product's compliance with the 
relevant requirements laid down in Annex I.” . 
(d) In subpoint (f), the introductory wording  is replaced by the following : 
“(f) For materials belonging to CMCs 3 and 5 , the output  material samples shall be taken 
on a regular basis with at least the following frequency: ”. 
(e) The following sub -points are inserted:  
“(fa) For materials belonging to CMC 12, t he output material samples shall be taken with at 
least the following default frequency, or sooner than scheduled if triggered by any significant 
change that may affect the quality of the EU fertilising product:  EN 7  EN  
Annual output (tonnes)   Samples  / year  
≤ 3000  4 
3001 – 10000  8 
10001 – 20000  12 
20001 – 40000  16 
40001 – 60000  20 
60001  – 80000  24 
80001 – 100000  28 
100001 – 120000  32 
120001 – 140000  36 
140001 – 160000  40 
160001 – 180000  44 
> 180000  48 
 
Manufacturers may reduce the default frequency of testing for contaminants as indicated 
above by considering the distribution of historical samples. After a minimum monitoring 
period of one year and a minimum number of 10 samples showing compliance with the 
requirements in Annex I and II, the manufacturer may reduce the default s ampling frequency 
for that parameter by a factor 2 in case  the greatest contaminant level  recorded  from  the last 
10 samples is smaller than half of the  limit value  for that parameter  laid down in Annex es I 
and II . 
(fb) For materials belonging to CMC 12, e ach batch or portion of production shall be assigned 
a unique code for quality management purposes. At least one sample per 3000 tonnes of these  
material s or one sample per two months, whichever occurs  soonest, shall be stored in good 
condition for a period  of at least 2 years. ”. 
(f) In sub -point (g) (iii), “.” is replaced by “,” and the following sub -point (iv) is added:  
“(iv) for materials belonging to CMC 12, m easure retainer samples  referred to in sub -point 
(fb) and take the necessary corrective actions to prevent possible further transport and use of 
that material. ”. 
(5) In point 5.1.4.1, t he introductory wording is  replaced by the following:  
“5.1.4.1.  For materials belonging to CMCs 3 , 5 and 12, as defined in Annex  II, the 
quality records shall demonstrate effective control of input materials, production, storage and 
compliance of input and output materials with the relevant requirements of this Regulation.  
Each document shall be legible and available at its relevan t place(s) of use, and any obsolete 
version shall be promptly removed from all places where it is used, or at least identified as 
obsolete. The quality management documentation shall at least contain the following 
information: ”.  
(6) In point 5.1.5.1 , the introductory wording  is replaced by the following:  EN 8  EN “5.1.5.1.  For materials belonging to CMCs 3 , 5 and 12, as defined in Annex II, the 
manufacturer shall establish an annual internal audit program in order to verify the 
compliance of the quality system, with th e following components:” . 
(7) Point 6.3.2  is replaced by the following:  
“6.3.2.  For materials belonging to CMCs 3, 5 and 12, as defined in Annex II, the notified 
body shall take and analyse output material samples during each audit, and th ose audits shall 
be carried out with the following frequency:  
(a) during the notified body’s first year of surveillance of the plant in question: the same 
frequency as the sampling frequency indicated in the table s included in point s 
5.1.3.1(f)  and, respectively, 5.1.3.1(f a); and  
(b) during the following years of surveillance: half the sampling frequency indicated in 
the table included in point 5.1.3.1(f) and, respectively, 5.1.3.1(f a).”.