EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council  as 
regards adding processed manure as a component material in EU fertilising products  
 
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Animal by -products  within the meaning of  Regulation (EC) No 1069/ 20091 are entire bodies 
or parts of animals, products of animal origin or other products obtained from animals, which 
are not intended for human consumption. Derived products are products obtained from one or 
more treatments, transformations or steps of processing o f animal by -products.  Derived 
products have a long tradition of use as national organic fertilisers and soil improvers, under 
the conditions laid down in Regulation (EC) No 1069/2009 and the national rules on 
fertilising products.  
Regulation (EU) 2019/100 92 lays down rules on the making available on the market of EU 
fertilising products. EU fertilising products are CE -marked and move freely in the internal 
market. They may contain derived products within the meaning of Regulation (EC) No 
1069/ 2009  having r eached the end point in the manufacturing chain as determined in 
accordance with that Regulation, provided that such derived products are listed in the table  in 
Component Material Catego ry 10 in Annex II to Regulation (EU) 2019/1009.   
The end point in the manufacturing chain is the moment as of when the derived products are 
no longer subject to the veterinary controls set out in Regulation (EC) No 1069/2009. As 
mentioned in the Communication on the availability and affordability of fert ilisers3, the 
definition of such end points constitute s an important step towards promoting  green and 
circular alternatives to natural gas and mined raw materials for fertiliser production .  
Pursuant to Article 5 of Regulation (EC) No 1069/2009, t he Commis sion assessed  derived 
products that are already widely used in the Union as organic fertilisers and soil improvers , 
including processed manure .  
The Commission determined the end point in the manufacturing chain for processed manure 
in Delegated Regulation  (EU) 2023/16054. 
In accordance with Article 42(5) of Regulation (EU) 2019/1009, t he Commission ’s Joint 
Research Centre  assess ed processed manure with respect to relevant aspects not taken into 
account for the purpose of determining an end point in the man ufacturing chain in accordance 
with Regulation (EC) No 1069/2009.  
This delegated Regulation lists processed manure in the table in Component Material 
Category 10 and sets out the requirements needed to ensure that EU fertilising products 
containing this component material are safe and agronomically efficient.   
                                                 
1 Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 
laying down health rules as regards animal by -products and derived products not intended for human 
consumption and repealing Regulation (EC) No 1774/2002 (Animal by -products Regulation), OJ L 300, 
14.11.2009, p. 1 .  
2 Regulation (EU) 2019/1009 of the European Parliament and of the Council of  5 June 2019 laying down 
rules on the making available on the market of EU fertilising products and amending Regulations (EC) 
No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/200 OJ L 170, 
25.6.2019, p. 1.  
3 Communication from the C ommission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions of 9 November 2022: Ensuring 
availability and affordability of fertilisers, COM/2022/590.  
4 Commission Delegated Regulation (EU) 2023/1605 of 22 May 2023 supplementing Regulation (EC) 
No 1069/2009 of the European Parliament and of the Council as regards the determination of end points 
in the manufacturing chain of certain organic fertilisers and soil improvers (OJ L 198, 8.8.2023, p . 1).  
EN 2  EN 2. CONSUL TATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 44(4) of Regulation (EU) 2019/1009, experts designated by each Member 
State  were consulted in the Commission expert group on Fertilising Products (E01320) 
according to the rules of the Interinsti tutional Agreement on Better Law -Making of 13 April 
20165. 
Details of these consultations can be found in the minutes of the meeti ngs held on 8 
December  2022 and 18 -19 April 2023 , as well as in the various position papers of interested 
stakeholders publicly available on the CIRCABC page of the group, at the following link:  
https://circabc.europa.eu/ui/group/36ec94c7 -575b -44dc -a6e9 -4ace02907f2f/library/b8e01334 -
4d39 -445d -bf4e-589356d55b1f   
Member States and interested stakeholders were largely supportive of the adoption of this 
delegated Regulation.  
The draft delegated Regulation has been published for feedback on the Better Regulation 
portal.  [add details]   
The draft delegated Regulation has also been notified based on Article 2(9)(2) of the 
Agreement on Technical Barriers to Trade.  [add details]    
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal act amends Regulation (EU) 2019/1009. The legal basis of this delegated act is 
Article 42(1)  of Regulation (EU) 2019/1009.  Article 42(5) of Regulation ( EU) 2019/1009 
provides further rules for adding derived products in Annex II of that Regulation.
                                                 
5 OJ L 123, 12.5.2016, p. 1 –14.  
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council  as 
regards adding processed  manure as a component material in EU fertilising products  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to  Regulation (EU) 2019/1009 of the European Parliament and o f the Council 
of 5 June 2019 laying down rules on the making available on the market of EU fertilising 
products and amending Regulations (EC) No 1069/ 2009 and (EC) No 1107/2009 and 
repealing Regulation (EC) No 2003/20031, and  in particular Article  42(1)  thereof,  
Whereas:  
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of 
EU fertilising products. EU fertilising products may contain derived products within 
the meaning of Regulation (EC) No 1069/2009 of the European Parliament a nd of the 
Council2. In accordance with Article 5 of Regulation (EC) 1069/2009, t he end point in 
the manufacturing chain for processed manure was determined in Commission 
Delegated Regulation (EU) 2023 /16053. 
(2) In accordance with Article 42(5) , second subpara graph,  of Regulation (EU) 
2019/1009, the Commission ’s Joint Research Centre  (JRC) assess ed processed manure 
with respect to relevant aspects not taken into account for the purpose of determining 
an end point in the manufacturing chain4.  
(3) Processed manure has the potential to be subject to significant trade in the internal 
market  as it is a derived product commonly used in the organic fertilisers and soil 
improvers . Laying down the requirements for the CE -marking of EU fertilising 
products containing proces sed manure would facilitate the trade of such products in 
the internal market. JRC concluded that the intro duction of processed manure in 
Component Material Category 10 in Annex II to Regulation (EU) 2019/1009  would 
also facilitate the implementation of  Council Directive 91/676/EEC5 by promoting the 
                                                 
1 OJ L 170, 25.6.2019, p. 1.  
2 Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 
laying down health rules as regards animal by -products and derived products not intended for  human 
consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1 ). 
3 Commission Delegated Regulation (EU)  2023 /1605  of 22 May 2023 supplementing Regulation (EC) 
No 1069/2009 of the European Parliament and of the Council as regards the determination of end points 
in the manufacturing chain of certain organic fertilisers and soil improvers  (OJ L 198, 8.8.2023, p. 1 ).  
4 Huygens , D, Technical proposals for processed manure as a component material for EU Fertilising 
Products  [placeholder – check with JRC the reference ] 
5 Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against 
pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).   
EN 4  EN transfer of processed manure from regions with a high density of nutrients to those 
with a low density.  
(4) Processed manure contains nitrogen and phosphorus, two of the thre e primary 
macronutrients. It has proven its agronomic value during a long history of use in the 
field.  
(5) To ensure that an EU fertilising product containing processed manure maintains its 
nutrient content over time , and thus its agronomic value, a stability criterion should be 
set out. Such a crit erion should ensure that the processed manure has  a low degree of 
organic matter decomposition. In addition to safeguarding the agronomic value of the 
products, it is possible that such a criterion would also imply additional processing to 
reduce the survival of weed seeds and would avoid nutrient emissions to the 
environment during storage.   
(6) An additional safety criterion  should be laid down to limit the content of 16 polycyclic 
aromatic hydrocarbons (PAH 16)6 which may be generated during the processi ng of 
manure. Regulation (EU) 2019/1021 of the European Parliament and of the Council7 
lays down release reductions for PAH 16 as unintentionally produced substances during 
manufacturing processes, but does not introduce a limit value in such cases. Given t he 
high risks generated by the presence of such pollutants in fertilising products, it is 
considered appropriate to introduce more stringent requirements than those laid down 
in  Regulation  (EU) 2019/1021 . Such a limit value  should be laid down at componen t 
material level, to ensure coherenc e with Regulation (EU) 2019/102 1 and should apply 
in addition to the safety criteria laid down in Annex I to Regulation (EU) 2019/1009 
for the corresponding product function category.  
(7) Processed manure may undergo additio nal processing to further improve its agronomic 
value  or its safe handling . The processing methods which are currently wi dely used , 
such as solid -liquid separation, drying, pelletising,  should be included in Regulation 
(EU) 2019/1009. As an additional safety measure, the additives needed in the 
processing of manure  should be registered based on Regulation (EC) No 1907/2006 of 
the European Parliament and of the Council8, in the extensive conditions  already laid 
down in Regulation (EU) 2019 /1009  for additives  in other component material 
categories . That would  ensure that the manufactu rers take into account the use of the 
additives in  a fertilising product when performing the risk assessment under 
Regulation  (EC) No 1907/2006  and that the reg istration is done also for low tonnage 
materials. The manure processing steps should not include thermochemical conversion 
processes at high temperatures or pressures, such as liquefaction, hydrothermal 
carbonisation, pyrolysis, gasification or combustion , as such processes are  covered 
under other component material categories  due to the specific nature of the material 
transformation process .    
                                                 
6 Sum of naphthalene, acenaphthy lene, 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.  
7 Regulation (EU)  2019/1021 of the European Parliament and of the Council of 20 June 2019 on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).  
8 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registr ation, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).   
EN 5  EN (8) Furthermore , processed manure  may be available on local market s in quantities that 
exceed demand . To ensure that market demand  for processed manure exists and that 
its long-term storage under suboptimal conditions does not lead to adverse 
environment al impacts , it is appropriate to limit the period of time during which it can 
be used as a component material for EU fe rtilising products .  
(9) A general labelling requirement should be introduced for EU fertilising products 
containing processed manure to inform end users about the potential negative impact 
of processed manure on air quality and to invite them to take appropri ate measures to 
reduce such impact .  
(10) Processed manure may contain  aminopyralid  or clopyralid , substances for which  
maximum residue levels  for food and feed are  set in accordance with Regulation (EC) 
396/2005 . Users of EU fertilising products containing such processed manure should 
therefore be fully informed  as regards the presence of these substances , so that they 
take the necessary measures to ensure that the resulting crop compl ies with th ose 
maximum residue  levels .’. 
(11) Regulation (EU)  2019/1009  should therefore be amended accordingly ,   
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2019/1009 is amended as follows:  
(1) Annex II is am ended in accordance with Annex I  to this Regulation;  
(2) Annex III is am ended in accordance with Annex II  to this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and dire ctly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen