EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards the requirements applicable to EU fertilising products containing inhibiting 
compounds and the post -processing of digestate  
This draft has not been adopted or endor sed 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  
Regulation (EU) 2019/1009  of the European Parliament and of the Council1 lays down rules 
on the making available on the market of EU fertilising products. It repeals Regulation (EC) 
No 2003/2003 of the European Parliament and of the Council2 as of 16 July 2022.  
Regulation (EU) 2019/1009 lays down harmonisation rules for vario us categories of fertilising 
products. This Regulation lays down  radically different harmonisation rules for inorganic 
fertilisers already regulated under varied types of EC fertilisers in Regulation (EC) No 
2003/2003. It also lays down harmonisation rules  for extensive categories of products , which 
are not yet subject to harmonisation rules, such as organic and organo -mineral fertilisers, soil 
improvers or growing media.  
While preparing the transition to the new harmonisation rules, both Member States and 
interested stakeholders informed the Commission on the need to adapt some technical 
provisions in the annexes to Regulation (EU) 2019/1009. Part of these adaptations have 
already been introduced by Commission Delegated Regulation (EU) 2021/17683.  
Certain adaptations  are necessary to facilitate internal market access for fertilising products 
that are agronomically efficient, safe and already widely traded on the market. Some of those 
amendments facilitate the free movement of such products, by improving the  consistency with 
other legal acts and policy objectives  of the Union.  Other amendments are necessary in order 
to avoid situations in which significant categories of fertilising products would inadvertently 
be excluded from the harmonisation rules.  
2. CONS ULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Member States were consulted in the Commission expert group on Fertilising Products 
(E01320) according to the rules of the Interinstitutional Agreement on Better Law -Making of 
13 April 20164 . 
Details of these con sultations can be found in the minutes of the meetings held on 22-
23 November 2021  (…), as well as in the various position papers of  interested stakeholders 
public ly 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. (to add details ) 
                                                 
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 Regulat ion (EC) No 2003 /2003 , OJ L 170, 25.6.2019, p. 1.  
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 –194. 
3 Commission Delegated Regulation (EU) 2021/1768 of 23 June 2021 amen ding, for the purpose of its 
adaptation to technical progress, Annexes I, II, III and IV to Regulation (EU) 2019/1009 of the 
European Parliament and of the Council laying down rules on the making available on the market of EU 
fertilising products, OJ L 356 , 8.10.2021, p. 8.  
4 OJ L 123, 12.5.2016, p. 1.   
EN 2  EN The draft delegated Regulation has also been notified based on Article 2( 9)(2) of the 
Agreement on Technical Barriers to Trade.  (to add details )  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated  act amends technical provisions in Annexes I, II, III and IV to Regulation (EU) 
2019/1009. The legal b asis of this delegated act is Article 42(1) of Regulation (EU) 
2019/1009.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the  Council as 
regards the requirements applicable to EU fertilising products containing inhibiting 
compounds and the post -processing of digestate  
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 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 Regulat ion (EC) No 2003/20031, and in particular Article 42(1) thereof,  
Whereas:  
(1) A fertilising product , which  meets  the requirements laid down  in Annex es I and II  to 
Regulation (EU) 2019/1009 for the relevant product function category ( ‘PFC’) and  
component materi al category ( ‘CMC ’) respectively , is labelled in accordance with 
Annex III to that Regulation and ha s successfully passed  the conformity assessment 
procedure  laid down  in Annex  IV to Regulation (EU) 2019/1009 , can then be CE 
marked and can move freely in the internal market  as an EU fertilising product .   
(2) While preparing for the transition to new harmonisation rules, both Member States and 
interested stakeholders informed the Commission about the need to adapt some of the 
technical provision s in the annexes to Regulation (EU) 2019/1009. Those adaptations  
are necessary to facilitate internal market access for fertilising products that are 
agronomically efficient, safe and already widely traded on the market. Some of those 
amendments facilitate  the free movement such products, i.e. safe and agr onomically 
efficient fertilisin g products, by improving the consistency with other legal acts and 
policy objectives  of the Union . Other amendments are necessary in order to avoid 
situations in which signif icant categories of fertilising products would inadvertently be 
excluded from the harmonisation rules.  
(3) Regulation (EU) 2019/1009, as amended by Commission Delegated Regulation (EU)  
2021/17682 allows manufacturers to use certain types of polymers in EU fer tilising 
products  if those are compliant with  the conditions laid down for CMC  1 and CMC  11 
in Annex II to that Regulation. One of the conditions is that the polymer is registered 
in accordance with  Regulation (EC) No 1907/2006 of the European Parliament a nd of 
the Council3. In the Communication titled ‘ Chemical s Strategy for Sustainability , 
                                                 
1 OJ L 170, 25.6.2019, p. 1.  
2 Commission Delegated Regulation (EU) 2021/1768 of 23 June 2021 amending, for the purpose of its 
adaptation to technical progress, Annexes I, II, III and IV to Regulation (EU) 2 019/1009 of the 
European Parliament and of the Council laying down rules on the making available on the market of EU 
fertilising products, OJ L 356, 8.10.2021, p. 8.  
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 Decembe r 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
  
EN 4  EN towards a Toxic -Free Environment’4, the Commission announced  the revision of 
Regulation  (EC) No 1907/2006  [reminder: update if needed ], extending  a regist ration 
obligation  to certain polymers . Consequently , for reasons  of coherence and 
consistency , the registration obligation of polymers should , as a first step,  be regulated 
under Regulation  (EC) No 1907/2006 , as the discussions for its revision offers a 
broader context and the possibility of taking a holistic approach , before being included  
in Regulation (EU) 2019/1009 . 
(4) Regulation (EU) 2019/1009 lays down a n obligation  for the  registration of magnesia  in 
accordance with  Regulation (EC) No 1907/2006 . However, Regu lation (EC) No 
1907/2006 exempts magnesia , which is  not chemically modified , from the registration 
obligation , as the registration is deemed inappropriate or unnecessary for that 
substance  and its exemption from the registration obligation  does not jeopardise the 
objectives of that  Regulation . Magnesia  has a long history of use  in fertilisers and has 
no harmonised classification in accordance with  Regulation (EC) No 1272/2008  of the 
European Parliament and of the Council5. Taking that into account an d in order to 
facilitate the access to the internal market of fertilisers containing magnesia as EU 
fertilising products , the registration obligation laid down in Regulation (EU) 
2019/1009 should no longer apply to magnesia used in fertilisers.  
(5) Regulation (EU) 2019/1009 lays down requirements for inhibitors as EU fertilising 
products belonging to PFC 5 and for EU fertilising products containing inhibitors as a 
component material belonging to CMC 1. To avoid any confusions, the terminology 
used in that Regul ation should be amended to reflect the distinction between the t wo 
situations.  Thus, the term ‘inhibiting compound’ should be used whenever it concerns 
a substance or mixture which improve the nutrient release pattern of a nutrient by 
delaying or stopping the activity of specific groups of micro -organisms or enzyme.  
The term “inhibitor” should be used only when it refers to EU fertilising products 
belonging to PFC 5. This distinction is important as inhibitors may be mixtures 
contain ing other substances , like stabilisers,  in addition to  inhibiting compounds. 
Correct use of those terms is necessary to facilitate the free movement of EU 
fertilising products, by clearly laying down the rules applicable in each situation.  
(6) Regulation (EU) 2019/1009 includes re quirements ensuring that the inhibiting 
compound s are efficient, but does not lay down requirements on the efficiency of 
fertiliser or the blend  containing such an inhibiting compound. The use of efficient 
products containing such substances helps avoiding  the environmental pollution 
caused by the leaching of nitrogen. Commission Communications titled ‘ Pathway to a 
Healthy Planet for All EU Action Plan: 'Towards Zero Pollution for Air, Wate r and 
Soil’6 and ‘ A Farm to Fork Strategy for a fair, healthy and en vironmentally -friendly 
                                                                                                                                                         
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1 488/94 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. ) 
4 Communication from the Commission to the European Parliament, the Council, the European 
Economic and So cial Committee and the Committee of the Regions: Chemicals Strategy for 
Sustainability, towards a Toxic -Free Environment, COM(2020) 667 final of [INSERT DATE].  
5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008  on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
6 Communication from the Commission to the Europea n Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions: Pathway to a Healthy Planet for 
  
EN 5  EN food system ’7 mention the environmental concerns and the ambitious targets to reduce 
nutrient losses  by 50%  by 2030 . It is therefore  important to ensure that the EU 
fertilising products , which contain inhibiting compounds, are efficient.  Therefore, 
Regulation (EU) 2019/1009 should be amended to include a requirement that 
inhibiting compounds are present in fertilisers  (PFC 1)  in a concentration that ensure s 
the efficiency  of such fertilisers . In addition, the manufacturers  should ensure that the 
blending of EU fertilising product s containing inhibiting compounds does not affect 
the performance of the inhibiting compounds therein. Furthermore, additional 
labelling requirements should ensure that the manufacturers of inhibito rs referred to in 
PFC 5  provide  clear instructions on how to mix such products with a fertiliser to 
ensure their efficiency.  
(7) Regulation (EU) 2019/1009 lays down rules on the use of fresh crop digestate and on 
digestate  other than fresh crop digestate , hereafter commonly referred to as ‘digestate’, 
as component materials in EU fertilising products. That Regulation lays down rules for 
the digestion processes . However, it  does not provide for  any other rules for post 
processing of the digestate.  
(8) The Joint Research Centre (JRC) report  titled ‘ End-of-waste criteria for biodegradable 
waste subjected to  biological  treatment (compost &  digestate): Technical proposals ’8 
states  that digestate  is often used in agriculture, either as a whole   or following 
separation in a solid and liquid fraction.  That separation facilitates the storing of 
materials and their long-distance transport, which is especially im portant for a CE 
marked product . The mechanical  separation of the  solid and liquid fracti ons of a 
digestate  is a commonly used method in some Member States  and seems to be a well-
established  method  according to a recent  study titled ‘ Digestate  and compost 
as fertilisers: Risk assessment and risk management options ’9. The separati on of  the 
solid  and liquid fraction of  a digestate  could pose limited risks if conditions regarding 
the post digestion process and the additives to be used  are laid down . Therefore,  
Regulation (EU) 2019/1009 should be amended to include  this post digestion  process, 
under the conditions that the additives used do not exceed a certain concentration and 
are registered in accordance with Regulation (EC) No 1907/2006. Allowing these 
processes  in Regulation (EU) 2019/1009 is necessary in order to facilitate the a ccess to 
the internal market of EU fertilising products containing digestate and adapt the 
requirements laid down for these component material categories to technical progress. 
It will also  create new opportunities for the recovery of bio -waste, which is in line 
with the overall ambitious plans for a circular economy.  
(9) Besides the mechanical separation of the solid and liquid fractions of a digestate, other 
processes are commonly used to remo ve water from a digestate or its fractions. 
Regulation (EU) 2019/1009 should allow manufacturers to further process the 
digestate or its fractions in order to extract water, as long as these processes do not 
                                                                                                                                                         
All EU Action Plan: 'Towards Zero Pollution for Air, Wate r and Soil', COM(2021) 400 final of 
[INSERT DATE].  
7 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions: A Farm to Fork Strategy for a fair, 
healthy and environmentally -friendly food system, COM (2020 ) 381 fina l of [INSERT DATE] . 
8 [JRC Publications Repository - End-of-waste criteria for biodegradable waste subjected to biological 
treatment (compost & digestate): Technical proposals  (europa.eu)  to replace with a reference]  
9 [https://ec.europa.eu/environment/chemicals/reach/pdf/40039 Dig estate and Compost RMOA - Final 
report i2_20190208.pdf  – to replace with a reference]  
  
EN 6  EN chemically modify the materials. Furthermore, ni trogen may be recovered out of a 
digestate via stripping. To close the loop, it is important not only to create the 
possibility for the recovery of nitrogen out of digestate , ending up with a high purity 
material, but also to allow for the use of the remai ning digestate in EU fertiliting 
products, given that it contains various other nutrients and organic matter.  
(10) Regulation (EU) 2019/1009 applies without prejudice to Regulation (EU) 2019/1021 
of the European Parliament and of the Council10, which lays down general rules 
applicable to persistent organic pollutants. Regulation (EU) 2019/1009 lays down a 
limit -value of 0.8 mg/kg dry matter of ndl -PCB  for pyrolysis and gasification 
materials  belonging to CMC 14 . However, in accordance with Regulation (EU) 
2019/2 021, PCB are not to be present in substances or  mixtures placed on the EU 
market.  To ensure coherence with Regulation (EU) 2019/1021 and clarity as to the fact 
that no ndl -PCB is to be contained in EU fertilising products with pyrolysis or 
gasification mat erials, that limit value in Regulation (EU) 2019/1009 should be 
deleted .  
(11) In accordance with Regulation (EU) 2019/1009 , EU fertilising products containing 
micro -organisms as specified in CMC 7 may be subject to the conformity assessment 
procedure described  in Module A, Internal production control. Such micro -organisms 
are contained in microbial plant biostimulants. In accordance with that Regulation, the 
conformity assessment of plant biostimulants  cann ot be done following Module A. To 
facilitate the free m ovement on the internal market of such products by avoiding any 
confusion  on the applicable conformity assessment procedure , the erroneous reference 
to micro -organisms in the rules concerning the applicability of that Module should be 
deleted .   
(12) 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 I is amended in accordance with Annex I to this Regulation;  
(2) Annex II is amended in accordance with Ann ex II to this Regulation ; 
(3) Annex III is amended in accordance with Annex III to this Regulation ; 
(4) Annex IV  is amended in accordance w ith Annex IV  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 . 
                                                 
10 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).   
EN 7  EN 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