EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
Commission Delegated Regulation  
amending Annexes II, III and IV to Regulation (EU) 2019/1009 of the European 
Parliament and of the Council for the purpose of adding thermal oxidation materials 
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 1 3: Thermal oxidation materials and derivates "; 
(2) Part II is amended as follows:  
(a) In point 1 of CMC 1 , the following sub -point (j ) is added:  
“(j) thermal oxidation materials or derivates  from recovered waste or by -products within the 
meaning of Directive 2008/98/EC , or”; 
(b) In point 1 of CMC 11, the following sub -point (f ) is added:  
“(f) thermal oxidation materials or derivates , from recovered waste or by -products within the 
meaning of Directive 2008/98/EC , or”; 
(c) The following  CMC 13 is added:  
“CMC 13: THERMAL OXIDATION MATERIALS OR DERIVAT ES 
1. An EU fertilis ing product may contain thermal oxidation materials obtained through 
thermochemical conversion under non -oxygen -limiting conditions exclusively from 
one or more of the following input materials : 
(a) 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 fro m air by any means, except  (*): 
– materials originating from mixed municipal waste,  
– sewage sludge, industrial sludge or dredging sludge,  and 
– animal by -products or derived products within the scope  of 
Regulation  (EC) No 1069/2009 ; 
(b) vegetable waste fr om the food processing industry and fibrous vegetable waste 
from virgin pulp production and from production of paper from virgin pulp, if 
not chemically modified ; 
(c) bio-waste fraction  resulting from subsequent treatment operations of bio -waste 
separately col lected for recycling within the  meaning of Directive 2008/98/EC, 
for which incineration delivers the best environmental outcome in accordance 
with Article 4 of that Directive  other than animal by -products or derived 
products within the scope  of Regulation (EC) No 1069/2009 ; 
(d) materials resulting from a controlled microbial or thermochemical conversion 
process using exclusively th e input materials referred to  in sub-point s (a), (b), 
and (c);  
(e) sewage sludge from municipal wastewater treatment plants , other than  animal 
by-products or derived products within the scope of Regulation (EC) No 
1069/2009 ; 
(f) materials from the independently operated treatment of waste water not 
covered by Council Directive 91/271/EEC* from food processing, pet food, 
feed, milk  and drink i ndustries , other than animal by -products or derived 
products within the scope of Regulation (EC) No 1069/2009 ;  EN 2  EN (g) waste within the meaning of Directive 2008/98/EC with the exception  (*)  of: 
– input materials  referred to  in sub-points (a)  to (f), 
– hazardous was te within the meaning of point 2 of Article 3   of Directive 
2008/98/EC,  
– materials originating from mixed municipal waste,  
– bio-waste within the meaning of point 4 of Article 3  of Directive 
2008/98/EC resulting from separate bio -waste collection at source, and 
– animal by -products or derived products within the scope of Regulation 
(EC) No 1069/2009 ; 
(h) auxiliary fuels (natural gas, liquefied gas, natural gas condensate, process gases 
and components thereof, crude -oil, coal, coke as well as their derived 
materials ), when used to process input materials referred to  in sub-points (a) to 
(g); 
(i) substances which are used  in production processes of the iron and steel 
industry; or  
(j) substances and mixtures, with the exception  (*) of: 
– input materials  referred to  in sub-points  (a) to (i), 
– 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,  and 
– animal by -products or derived products within the scope of Regulation 
(EC) No 1069/2009.  
2. Notwithstanding point 1, a n EU fertilising product may contain thermal oxidation 
materials  obtained through thermochemical conversion under non -oxygen -limiting 
conditions from Category 2 or Categor y 3 material s 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, prov ided 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 3 , 4, and 5 are met.  
3. The thermal oxidation shall take place unde r non -oxygen limiting conditions in such 
a way that the gas resulting from the thermochemical conversion process  is raised, 
after the last injection of combustion air, in a controlled and homogeneous fashion 
and even under the most unfavourable conditions to a temperature of at least 850°C EN 3  EN for at least 2 seconds. These conditions shall apply to all input materials, with the 
exemption of : 
(a) the input materials  referred to  in points 1(a), (b) and ( h), or resulting from a 
controlled microbial or thermochemical conversion process using exclusively 
those materials , and  
(b) input materials  referred to in point 2,  
for which  a temperature  of at least 450°C for at least 0.2 seconds shall apply ; 
4. The thermal oxidation shall take place in an incineration or combustion cham ber. 
The chamber may only process input materials, which are not contaminated 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 
contaminated with other material streams unintentionally in a one -off incident 
resulting only in trace levels of exogenous compounds.  
All of the following conditions shall be met i n the plant, where the thermal oxidation 
takes place:  
(a) the production lines for the proces sing of input materials referred to in point s 1 
and 2 shall be clearly separated from production lines for the processing of  
other  input materials , 
(b) the input material shall be  oxidised  in such a way that the total organic carbon 
(Corg) content of the resulting slags and bottom ashes is less than 3  %,  
(c) physical contact between input and output materials shall be  avoided  after the 
thermochemical conversion process , including during storage.  
5. The thermal oxidation materials shall be ashes or slags, and have no more than : 
(a) 6 mg/kg dry matter of PAH 16(***) ,  
(b) 20 ng WHO toxicity equivalents  (****) of PCDD/F  (*****) /kg dry matter.  
6. An EU fertilis ing product may contain derivates from thermal oxidation materials 
that have been produced from the input materials referred to  in point s 1 and 2 that 
meet the conditions of  point 5 and that have been manufactured by a thermochemical 
conversion process in accordance  with points 3 and 4.  
The derivate manufacturing process shall be executed so as to intentionally modify 
the chemical composition of the thermal oxidation material . 
The derivate manufacturing process  shall be of the following nature:  
(a) chemical manufacturing: derivates are produced through one or more chemical 
manufacturing steps that react thermal oxidation materials with input materials 
referred to  in sub-point 1( j) that are consumed in or used for chemical 
processing  whereas n on-biodegradable polymers shall not be used ; 
(b) thermochemical manufacturing: derivates are produced through one or more 
manufacturing steps that thermochemically react thermal oxidation materials 
with reactants referred to  in point s 1 and 2 that are consumed in or used for 
chemical processing.  
Thermal oxidation materials that display one or more of the h azardous properties 
listed in Annex III to Directive 2008/98/EC shall not be mixed or reacted, either with 
waste, substances or materials with the intention of reducing hazardous substances to EN 4  EN levels below the limit values for the hazardous property as laid down in Annex III to  
that Directive. Using a mass balance approach, manufacturers that use thermal 
oxidation materials with hazardous properties must demonstrate the removal or 
transformation of the contaminants to levels below the limit values laid down  in 
Annex III to Directive 2008/98/EC.  
7. Contaminants in an EU fertilising product containing or consisting of t hermal 
oxidation materials or derivates must not exceed the following limit values : 
(a) total chromium (Cr) : 400 mg /kg dry matter, if the thermal oxidation materials 
or derivates  are from input materials referred to  in sub-point s 1(e), (g) or (i); 
(b)  thallium (Tl): 2 mg/kg dry matter, if the thermal oxidation materials or 
derivates are from input materials referred to  in sub-point s 1(e), (g), (h) or (i);  
The chlorine (Cl-) content shall not be higher than 30 g/kg of dry matter. However, 
this limit value shall not apply to EU fertilising products produced through a 
manufacturing process where a Cl- containing compound  has been added with the 
intention of producing alkali metal salts or alkaline earth metal salts,  and is declared 
in accordance with Annex III ;  
The vanadium (V) content shall not be higher than 600 mg/kg dry matter if the 
thermal oxidation materials or derivates are from input ma terials referred to  in sub-
point s 1(g) or (i). 
8. The thermal oxidation materials or derivates shall have been registered pursuant to 
Regulation (EC) No 1907/2006, in a dossier containing:  
(a) the information provided for by Annexes VI, VII and VIII of Regulation  (EC) 
No 1907/2006, and  
(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 Regula tion (EC) No 1907/2006 or by points 6, 7, 8 or 9 of Annex 
V to that Regulation.  
______________________________________________________________  
(*) 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 . 
(**) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste -water treatment 
(OJ L 135, 30.5.1991, p. 40). ” 
(***) 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 . 
(****) van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) 
The 2005 World Health Organization Re -evaluation of Human and Mammalian Toxic 
Equivalency Factors for Dioxins and Dioxin -like Compounds. Toxicological sciences: an 
official journal of the Society of Toxicology 93:223 -241. doi:10.1093/toxsci/kfl055 . 
(*****) P olychlorinated dibenzo -p-dioxins and dibenzofurans . 
  EN 5  EN ANNEX II 
 
In Annex III , Part I to  Regulation (EU) 2019/1009, the  following  point is inserted : 
“7a. Where the EU fertilising product contains or consists of thermal oxidation materials or 
deriva tes referred to in CMC 13 in Part II of Annex II and has a  manganese ( Mn) content 
above 3 ,5 % by mass, the manganese  content shall be declared.”  
  EN 6  EN ANNEX III 
 
Module D1 (Quality assurance of the production process ) in Part II of Annex IV to Regulation 
(EU) 2019/1009  is amended as follows:  
(1) Point 2.2  is amended as follows :  
(a) 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, 12 or 13 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, ”; 
(b) the  following  sub-point (ga) is i nserted:  
“(ga) hazardous waste calculations for EU fertilising products containing or consisting of 
CMC 13; the testing referred to in point 6 in CMC 13 in Part II of Annex II shall be carried 
out at least every year, or sooner than scheduled in case of an y significant change that may 
affect the safety or quality of the EU fertilising product ( for example  processing of input 
material batches of different composition, modification of process conditions). For a 
representative input material batch that is proc essed at the plant, the hazardous property 
identified ( in accordance with point 5.1.3.1) and the total mass shall be measured on the 
different input materials (1, …, n) and on the output material that will be incorporated in the 
EU fertilising product. The  incorporation rate of the hazardous property into the output 
material shall then be calculated as  follows :  
 
𝑖𝑛𝑐𝑜𝑟𝑝𝑜𝑟𝑎𝑡𝑖𝑜𝑛  𝑟𝑎𝑡𝑒  (%)= 𝐻𝑃𝐶 𝑜𝑢𝑡𝑝𝑢𝑡  𝑚𝑎𝑡𝑒𝑟𝑖𝑎𝑙   × 𝑀𝑜𝑢𝑡𝑝𝑢𝑡  𝑚𝑎𝑡𝑒𝑟𝑖𝑎𝑙  
∑ (𝐻𝑃𝐶 𝑖𝑛𝑝𝑢𝑡  𝑚𝑎𝑡𝑒𝑟 𝑖𝑎𝑙,   𝑖 × 𝑛
𝑖= 1 𝑀𝑖𝑛𝑝𝑢𝑡  𝑚𝑎𝑡𝑒𝑟𝑖𝑎𝑙 ,   𝑖)  
 
Where:  
HPC = the concentration of the hazardous property (mg/kg),  
M = the total mass (kg), and  
i (1-n) = the different input materials u sed in the production process.  
 
The removal of the hazardous property during the production process shall be such that the 
incorporation rate multiplied by the concentration of the hazardous property of each 
individual input material is below the limit values laid down  in Annex III to Directive 
2008/98/EC for that hazardous property. ”. 
 
(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, 12 and 13, as defined in Annex II, senior 
management of the manufacturer's organis ation shall:” . 
(3) Point 5.1.2.1  is replaced by the following : 
“5.1.2.1. For materials belonging to CMCs 3, 5 , 12 and 13 , as defined in Annex II, the quality 
system shall ensure compliance with the requirements laid down  in that Annex.” . EN 7  EN  
(4) Point 5.1.3.1 is amen ded as follows:  
(a) The introductory wording  is replaced by the following:  
“5.1.3.1. For materials belonging to CMCs 3 , 5, 12 and 13, as defined in Annex II, the 
examinations and tests shall comprise the following elements:”;  
(b) Sub-point s (b) and (c) are  replace d 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 , 12 and 13  
laid down in Annex II.  
(c) The manufacturer shal l refuse any consignment of any given input material where visual 
inspection raises any suspicion of  any of the following:   
(i) the presence of hazardous or damageable substances for the process or for the quality 
of the final EU fertilising product ; 
(ii) incompatibility with the specifications of CMCs 3, 5 , 12 and 13 in Annex II, in 
particular by presence of plastics leading to exceedance of the limit value for 
macroscopic impurities. ”; 
(c) Sub-point (e) is replaced by the following:  
“(e) Samples shall be take n on output materials, to verify that they comply with the 
specifications laid down in CMCs 3, 5 , 12 and 1 3, as defined in Annex II, and that the 
properties of the output material do not jeopardise the EU fertilising product's compliance 
with the relevant requirements laid down in Annex I.”;  
(d) In sub -point (fa), t he introductory wording  is replaced by the following :  
“(fa) For materials belonging to CMCs 12 and 13, t he output material samples shall be taken 
with at least the following default frequency, or so oner than scheduled in case of  any 
significant change that may affect the quality of the EU fertilising product: ”; 
(e) Sub-point (fb) is replaced by the following : 
“(fb) For materials belonging to CMCs 12 and  13, 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  soone r, shall be stored in 
good condition for a period of at least two years. ”;  
(f) Sub-point (g)(iv) is replaced by the following:  
“(iv) for materials belonging to CMCs 12 and 13, m easure retainer samples  referred to in sub -
point (fb)  and take the necessary corrective actions to prevent possible further transport and 
use of th at material .”. 
(5) In point 5.1.4.1 , the introductory wording  is replaced by the following:  
“5.1.4.1.  For materials belonging to CMCs 3 , 5, 12 and  13, 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 relevant place(s) of use, and any obsolete 
version shall be promptly removed from all places where it is use d, or at least identified as 
obsolete. The quality management documentation shall at least contain the following 
information: ”.   EN 8  EN (6) In point 5.1.5.1 , the introductory wording  is replaced by the following:  
“5.1.5.1.  For materials belonging to CMCs 3 , 5, 12 and 13, 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 the following components:” . 
(7) In point 6.3.2 , the introductory wording is replaced by the followi ng: 
“6.3.2.  For materials belonging to CMCs 3, 5 , 12 and 13, 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:” .