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 pyrolysis or gasification 
materials 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 14: Pyrolysis and gasification materials";  
(2) Part II is amended as follows:  
(a) In point 1 of CMC 1, the following  sub-point (k) is added:  
“(k) pyrolysis and gasification materials  from recovered waste or by -products within the 
meaning of Directive 2008/98/EC .”; 
(b) In point 1 of CMC 11, the foll owing  sub-point (g) is added:  
“(g) pyrolysis and gasification materials  from recovered waste or by -products within the 
meaning of Directive 2008/98/EC .”; 
(c) The following  CMC 1 4 is added:  
“CMC 14: PYROLYSIS AND  GASIFICATION MATERIALS  
1. An EU fertilis ing product may contain pyrolysis or gasification materials obtained through 
the thermochemical conversion under oxygen -limiting conditions of exclusively one or more 
of the following input materials : 
(a) living or dead organisms or parts thereof, which are un processed or processed only 
by manual, mechanical or gravitational means, by dissolution in water,  by flotation, 
extraction with water, by steam distillation or by heating solely to remove water, or 
which are extracted from air by any means, except  (*): 
– materials originating from mixed municipal waste,  
– sewage sludge, industrial sludge or dredging sludge, and   
– animal by -produ cts or derived products within the scope  of Regulation  (EC) 
No 1069/2009 ; 
(b) vegetable waste from the food processing industry and fibrou s vegetable waste from  
virgin pulp production and from production of paper from virgin pulp, if not 
chemically modified;  
(c) processing residues within the meaning of point (t) of Article 2 of  Directive 
2009/28/EC  from the production of bioethanol and biodiese l, derived  from materials 
referred to  in sub-points ( a), (b) and (d) ;  
(d) 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  or 
(e) pyrolysis or gasification additives which are necessary to improve the process  
performance or the environmental performance of the pyrolysis  or gasification 
process, provided that th ose additives are consumed in chemical processing or used 
for such processing and that total conce ntration of all additives do not exceed 25 % 
of the fresh matter of the total input material , with the exception  (*) of: 
– input materials referred to in sub -points (a) to (d),   
– waste within the meaning of point 1 of Article 3 of Directive 2008/98/EC,   EN 2  EN – 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, and   
– animal by -products or de rived products within the scope of Regulation (EC) 
No 1069/2009.  
An EU fertilis ing product may contain pyrolysis or gasification materials  obtained through 
thermochemical conversion under oxygen -limiting conditions  of any input material referred to  
in sub-points (a)  to (e), or combination thereof, processed by  manual, mechanical or 
gravitational means, by solid -liquid fractionation using biodegradable polymers, by 
dissolution in water,  by flotation, by extraction with water, by steam distillation or  by heating 
solely to remove water, by composting or by anaerobic digestion.  
 
2. The thermochemical conversion process shall take place under oxygen -limiting conditions 
in such a way that a temperature of at least 180°C for at least two seconds is reached in the 
reactor.  
 
The pyrolysis or gasification reactor may only process input materials, which are not 
contaminated with material streams, or input materials , other than animal by -products or 
derived products within the scope of Regulation (EC) No 1069/2009 whic h have been 
contaminated with other material streams unintentionally in a one -off incident, resulting only 
in trace  levels of exogenous compounds.  
 
In the plant where the pyrolysis or gasification takes place, physical contacts between input 
and output materials shall be avoided after the thermochemical process, including during 
storage.  
 
3. The pyrolysis and gasification materials  shall have  a molar ratio of hydrogen (H) to organic 
carbon (H  / Corg) of less than 0 ,7, with testing to be performed in the dry and ash -free fraction 
for materials that have an organic carbon (C org) content of less than 50  %. They  shall 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 , 
(c) 0,8 mg /kg dry matter of ndl-PCB (*****) ,  
(d) 30 g/kg chlorine (Cl-) on a dry matter basis,  
(e) 2 mg/kg dry matter of thallium (Tl), in case more than 5  % of pyrolysis  or 
gasification additives  relative to  the fresh weight  of total input material have been 
applied . 
4. Notwithstanding point 1, a n EU fertilising product may contain pyrolysis or gasification 
materials  obtained through the thermochemical conversion under oxygen -limiting conditions 
of Category 2 or Category 3 material s or derived products thereof , in accordanc e with  the 
conditions set out in Article 32 (1) and (2) and in the measures referred to in Article 32(3)  of EN 3  EN 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.  
5. In the plant where the pyrolysis or gasification takes place, the production lines for the 
processing of input materials referred to in points 1  and 4  shall be clearly separated from 
production lines for the processing of other input materials.  
6. The pyrolysis and gasification material shall have been registered pur suant to Regulation 
(EC) No 1907/2006, in a dossier containing : 
(a) the information provided for by Annex 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 Regulation  (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.  
(**) Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anth racene, 
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:10.109 3/toxsci/kfl055 . 
(****) Polychlorinated dibenzo -p-dioxins and dibenzofurans . 
(*****) Sum of congeners PCB 28, 52, 101, 138, 153, 180 . EN 4  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 and 
derivates as referred to in CMC 13 in Part II in Annex II or pyrolysis or gasification materials 
as referred to in CMC 14 in Part II of that Annex and has a  manganese ( Mn) content above 
3,5 % by mass, the manganese  content shall be declared.” . 
 
  EN 5  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) 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, 12, 13 or 14 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) In point 5.1.1.1 , the introductory wording  is repla ced by the following:  
“5.1.1.1. For materials belonging to CMCs 3 , 5, 12, 13 and 14 , 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, 12, 13 and 14 , 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, 12, 13 and 14 , as defined in Annex 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 consig nment of input materials 
and verify compatibility with the specifications of input materials in CMCs 3, 5 , 12, 13 and 14 
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 , 12, 13 and 14 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 taken on output materials, to verify that they comply with the 
specifications laid down in CMCs 3, 5 , 12, 13 and 14 , 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, 13 and 14, t he output material samples shall be 
taken with at least the  following default frequency, or sooner 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 : EN 6  EN “(fb) For materials belonging to CMCs 12, 13 and 14, e ach bat ch 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, 13 and 14, 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, 13 and 14 , 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 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:  
“5.1.5.1.  For materials belonging to CMCs 3 , 5, 12, 13 and 14 , as defined in Annex II, 
the manufacturer shall establish an annual internal audit program in order to verify the 
compliance of the qualit y system, with the following components:”;  
(7) In point 6.3.2 , the introductory wording is replaced by the following:  
“6.3.2.  For materials belonging to CMCs 3, 5 , 12, 13 and 14 , as defined in Annex II, the 
notified body shall take and analyse output material  samples during each audit, a nd th ose 
audits shall be carried out with the following frequency:”.