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 thermal oxidation materials 
and derivates as a component material category in EU fertilising products  
(Text with EEA rel evance)  
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 
2003/20032 and shall apply from 16 July 2022.  
Further, Article 42(2) of Regulation (EU) No 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 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 derived 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 de legated 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 with the conditions laid down in 
Article 6 of Directive 2008/98/EC  (3). This delegated regulation establishes recovery 
operations for thermal oxidation materials and derivates 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.  
In  this context, this delegated regulation amends Annex II to Regulation (E U) 2019/1009 by 
adding  thermal oxidation materials and derivates as a new Component Material Category, 
Annex III by adding labelling requirements to EU fertilising products containing thermal 
oxidation materials and derivates and Annex IV to the Regulation  by setting the legal 
framework for the relevant conformity assessment  for such products . 
 
                                                 
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 Council of 19 November 2008 on waste 
and repealing certain Directives, OJ L 31 2, 22.11.2008, p. 3 –30.  
EN 2  EN 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 t he Commission 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 thermal oxidation materials 
and derivates as a component material category in EU fertilising products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Fun ctioning of the 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 product s contain component 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 paragraph of Article  42(1) of that Regulation requires the Com mission to assess  
ash-based products 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 s do not present a risk to human, animal or plan t health, to 
safety or to the environment , and ensure agronomic efficiency . 
(3) Ash-based products  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. Purs uant to Article  42(3) of Regulation (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 ash-based products in  Annex  II to 
Regulation (EU) 2019/1009 only if recovery rules in that Annex ensure that the 
material s are to be used for specific purposes, that a market or demand exists for them , 
and that their use will not lead to overall adverse environmental or human health 
impacts.  
(4) The Commission ’s Joint Research Center (’JRC’)  began its assessment of ash -based 
products in anticipation of the adoption of Regulation (EU) 2019/1009, and concluded 
it in 2019. Throughout the assessment, the scope was widened to include th e broad 
spectrum of thermal oxidation materials, as well as their derivates.  
                                                 
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).   
EN 4  EN (5) JRC’s  report  (3) concludes that thermal oxidation materials and derivates, if produced 
following the recovery rules suggested in the report, provide plants with nutrients or 
impr ove their nutrition efficiency  and therefore ensure agronomic efficiency.  
(6) JRC’s assessment report furthermore concludes that there is an existing and growing 
market demand for thermal oxidation materials and derivates, and that those materials 
are likely to be used to provide nutrient inputs to European agriculture. It further 
concludes that the use of thermal  oxidation materials and derivates , 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 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. That 
assessment report also concludes that fertilising products containing t hermal  oxidation 
materials and derivates 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 thermal oxidation materials and 
derivates, if produced followin g the recovery rules suggested i n JRC’s report, ensure 
agronomic efficiency within the meaning of point (b)(ii) of the first subparagraph of 
Article  42(1) of Regulation (EU) 2019/1 009. 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 in Annex I 
to that Regulation in particular, they will n ot present a risk to human, ani mal 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 . Therefore, thermal 
oxidation materials and derivates should be i ncluded in Annex II to Regulation (EU) 
2019/1009  subje ct 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 Parliament and of the Council(4)  
should only be all owed as input materials for thermal oxidation materials and derivates 
governed by Regulation (EU) 2019/1009, if and when their end points in the 
manufacturing chain have been determined in accordance with the third subparagraph 
of Article 5(2) of Regulatio n (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 thermal 
oxidation materials or derivates.  
(10) Furthermore , given the fact that thermal oxidation materials and derivates  can be 
considered to be recovered waste or by -products within the meaning of Directive 
2008/98/EC, such materials should be excluded from the component material 
                                                 
3 Huygens D, Saveyn HGM, Tonini D, Eder P,  Delgado Sancho L, Technical proposals for selected new  
fertilising materials under the Fertilising Products Regulation (Regulation (EU) 2019/1009) - Process 
and quality criteria, 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, 2019, 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 Reg ulation), OJ L 300, 
14.11.2009, p. 1 –33  
EN 5  EN categories 1 and 11 of Annex  II to Regulation  (EU) 2019/1009 pursuant to the third 
subp aragraph  of Article 42(1) of that  Regulation.  
(11) It is important to ensure that fertilising products containing thermal oxidation 
materials and derivates will follow additional labelling rules and will be subject to a 
conformity assessment procedure including a quali ty 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 conformity 
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 2022, it is necessary to defer  the application of 
this Regulat ion to the same date ,   
HAS ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2019/1009 is amended as follows:  
(1) Annex II is amended in accordance with Annex I to this Regulation;  
(2) Annex III is amended in accordance with Annex II to this Regulation;  
(3) Annex IV is amended in accordance with Annex III 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 . 
It shall apply from 1 6 July 2022.  
This Regu lation 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