EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II, III and IV to Regulation (EU) No 2019/1009 of the European 
Parliament and of the Council for the purpose of adding pyrolysis and gasification 
materials as a component material category in EU fertilising products  
(Text with EEA relevanc e) 
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  
According to Article 42(1) of the Fertilising Products Regulation  (1), the Commission is 
empowered to adopt delegated acts in accordance with Article 44 amending Annex II for the 
purposes of adapting the Annex to technical progress and of facilitating internal market access 
and free movement for EU fertilising products, which have a potential to be the subject of 
significant trade on the internal market and for which there is scientific evidence that they do 
not present a risk to human, animal or plant health, to safety or to the environment and that 
they do ensure agronomic efficiency. Regulat ion (EU) 2019/1009 repeals Regulation (EC) No 
2003/2003  (2) and shall apply from 16 July 2022.  
Further, Article 42(2) of Regulation (EU) 2019/1009 obliges the Commission to assess 
STRU vite, BIochar and ASh-based products (hereinafter jointly referred to as  ‘STRUBIAS’) 
without undue delay after the date of entry into force and to adopt delegated acts to include 
those materials in Annex II if the abovementioned criteria pertaining to scientific evidence are 
fulfilled.  
Such an assessment has been concluded by  the Commission based on  a report by the 
Commission’s Joint Research Center (‘JRC’) on technical and market conditions for a 
possible legal framework for the manufacturing and placing on the market of specific safe and 
effective fertilising products derive d from STRUBIAS . The report includes technical 
proposals on eligible input materials and process conditions for STRUBIAS production 
pathways, quality requirements for STRUBIAS materials, and quality management systems. 
The report also provides information on the added value that the STRUBIAS materials could 
provide for food security, food safety, environmental protection, and the EU fertilising and 
agricultural sector.  
In accordance with Article 42(3) of Regulation (EU) 2019/1009, the Commission may only 
adopt delegated acts pursuant to that Article to include materials  in Annex II to the Regulation 
that cease to be waste following a recovery operation, if recovery rules in that Annex, adopted 
no later than the inclusion, ensure that the materials comply wit h the conditions laid down in 
Article 6 of Directive 2008/98/EC  (3). This delegated regulation establishes recovery 
operations for pyrolysis and gasification material s, ensuring that they comply with the 
conditions laid down in Directive  2008/98/EC. Consequently, the requirement set out in 
Article 42(3) of Regulation (EU) 2019/1009 is fulfilled.  
                                                 
1 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 2003/2003, OJ L 170, 
25.6.2019, p. 1 –114. 
2 Regulation (EC) No 2003/2003 of the European Parliament and of the Council  of 13 October 2003 
relating to  fertilisers (OJ L 304, 21.11.2003, p. 1).  
3 Directive 2008/98/EC of the European Parliament and of the Cou ncil of 19 November 2008 on waste 
and repealing certain Directives, OJ L 312, 22.11.2008, p. 3 –30.  
EN 2  EN In  this context, this delegated regulation amends Annex II to Regulation ( EU) 2019/1009 by 
adding pyrolysis and gasification materials as a new Component Material Category, Annex III 
by adding labelling requirements to EU fertilising products containing pyrolysis and 
gasification materials and Annex IV to the Regulation by setti ng the legal framework for the 
relevant conformity assessment for such products . 
2. CONSULTATIONS  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 Commiss ion expert group on Fertilising Products (E01320) 
according to the rules of the Interinstitutional Agreement on Better Law -Making of 13 April 
2016.  
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.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annexes II, III and IV to Regulation (EU) No 2019/1009 of the European 
Parliament and of the Council for the purpose of adding pyrolysis and gasification 
materials as a component material category in EU fertilising products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of th e European Union , 
Having regard to  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 2003/2003  (1), and in particular Article  42(1) thereof,  
Whereas:  
(1) Regulation (EU) 2019/1009  lays down rules on the making available on the ma rket of 
EU fertilising products. EU fertilising products contain comp onent materials of one or 
more of the categories listed  in Annex II to that Regulation.  
(2) Article  42(2) of Regulation  (EU) 2019/1009  read in conjunction  with point (b) of the 
first subparagraph of Article  42(1) of that Regulation requires the Commission to 
assess biochar without undue delay after 15 July 2019 , and to include it in Annex  II to 
that Regulation if that assessment concludes that EU fertilising products containing 
that material do not present a risk to human, animal or plant health, to safety or to the 
environment, and ensure agronomic efficiency.  
(3) Biochar can be waste, and can in accordance with Article 19 of Regulation (EU) 
2019/1009 cease to be waste if it is contained in a compliant EU fertilising product. 
Pursuant to Article  42(3) of Regulatio n (EU) 2019/1009 read in conjunction  with 
Article 6 of Directive  2008/98/EC  of the European Parliament and of the Council  (2), 
the Commission may therefore include biochar in Annex  II to Regulation (EU) 
2019/1009 only if recovery rules in that Annex ensure  that the material is to be used 
for specific purposes, that a market or demand exists for it, and that its use will not 
lead to overall adverse environmental or human health impacts.  
(4) The Commission ’s Joint Research Centre (’JRC’)  began its assessment of b iochar in 
anticipation of the adoption of Regulation (EU) 2019/1009, and concluded it in 2019. 
Throughout the assessment, the scope  was widened to include the broad spectrum of 
pyrolysis and gasification materials.   
(5) JRC’s  assessment report  (3) concludes th at pyrolysis and gasification materials , if 
produced following the recovery rules suggested in the report, provide plants with 
                                                 
1 OJ L 170, 25.6.2019, p. 1.  
2 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).  
3 Huygens D, Saveyn HGM, Tonini D, Eder P, Delgado Sancho L, Technical proposals for selected new   
EN 4  EN nutrients or improve their nutrition efficiency  and therefore ensure agronomic 
efficiency .  
(6) JRC’s assessment report  furthermore c oncludes that there is an existing and growing 
market demand for pyrolysis and gasification materials , and that those materials are 
likely to  be used to provide nutrient inputs to European agriculture. It further 
concludes that the use of pyrolysis and gas ification materials , if produced following  
the recovery rules  suggested in the report , does not lead to overall adverse 
environmental or human health impacts.  
(7) The recovery rules suggested in the JRC’s assessment report include measures to limit 
the risks of recycling or producing contaminants, such as creating an exhaustive list of 
eligible input materials and excluding for example  mixed municipal waste, and laying 
down specific processing conditions and product quality requirements. Th at 
assessment report  also concludes that the fertilising products containing pyrolysis and 
gasification materials should follow specific labelling rules and that the conformity 
assessment rules applicable to such products should include a quality system assessed 
and approved by a notified body.   
(8) Based on the above, the Commission  concludes that pyrolysis and gasification 
materials, if produced following the recovery rules suggested in JRC’s report, ensure 
agronomic efficiency  within the meaning of point (b)(ii) of the first subparagraph of 
Article  42(1) of Regulation (EU) 2019/1009. Furthermore,  they comply with the 
criteria laid down in Article  6 of Directive  2008/98/EC . Finally, if compliant with the 
other requirements laid down in Regulation  (EU) 2019/1009 in general and i n Annex  I 
to that Regulation in particular, they will not present a risk to human, animal or plant 
health, to safety or to the environment , within the meaning of point (b)(i) of the first 
subparagraph of Article  42(1) of Regulation (EU) 2019/1009.  Therefor e, pyrolysis and 
gasification materials should be included in Annex  II to Regulation  (EU) 2019/1009 
subject to those recovery rules.   
(9) In particular, animal by -products or derived products within the meaning of 
Regulation (EC) No 1069/2009 of the European P arliament and of the Council(4)  
should only be allowed as input materials for pyrolysis and gasification materials 
governed by Regulation (EU) 2019/1009, if and when their end points in the 
manufacturing chain have been determined in accordance with the t hird subparagraph 
of Article 5(2) of Regulation (EC) No 1069/2009 and will be reached at the latest by 
the end of the production process of the EU fertilising product containing the pyrolysis 
or gasification materials.  
(10) Furthermore, given the fact that pyr olysis and gasification materials can be considered 
to be  recovered waste or by -products within the meaning of Directive 2008/98/EC , 
such materials should be excluded from component material categories 1 and 11 of 
Annex II to Regulation (EU) 2019/1009 purs uant to in the third subparagraph of 
Article 42(1) of that Regulation.  
                                                                                                                                                         
fertilising materials under the Fertilising Products Regulation (Regulation (EU) 2019/1009) - Process 
and quality cri teria, and assessment of environmental and market impacts for precipitated phosphate 
salts & derivates, thermal oxidation materials & derivates and pyrolysis & gasification materials, EUR 
29841 EN, Publications Office of the European Union, Luxembourg, 201 9, ISBN 978 -92-76-09888 -1, 
doi:10.2760/186684, JRC117856.  
4 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 –33  
EN 5  EN (11) It is important to ensure that fertilising products containing pyrolysis and gasification 
materials  follow specific labelling rules and are subject to a conformity assessment 
procedure including a quality system assessed and approved by a notified body. It is 
therefore necessary to amend Annex III and Annex IV to Regulation (EU) 2019/1009 
to provide for labelling requirements and for a confor mity assessment appropriate for 
such fertilising products . 
(12) Given that the requirements set out in Annexes II and III to Regulation (EU) 
2019/1009 and the conformity assessment procedures set out in Annex IV to that  
Regulation are to apply as of 16  July 202 2, it is necessary to defer  the application of 
this Regulation to the same date ,   
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation ( EU) 2019/1009  is amended as follows:  
(1) Annex I I is amended in accordance with Annex I to this Regulation;  
(2) Annex III is amended in accordance with Annex I I to this Regulation;  
(3) Annex IV  is amended in accordance w ith Annex III to this Regulation.   
Article  2 
This Regulation shall enter into force on the  twentieth  day following that of its publication in 
the Offici al Journal of the European Union . 
It shall apply from 1 6 July 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen