EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards biodegradability criteria for coating agents and water retention polymers  
(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  
On 5 June 2019, the European Parliament and the Council adopted Regulation (EU) 
2019/1009 laying down rules on the making available on the market of EU fertilising 
products1. Regulation (EU) 2019/1009 sets out an obligation for  the Commission to assess 
biodegradability criteria for certain polymers used in EU fertilisi ng products to control the 
release of nutrients ( ‘coating agents ’) or to increase the water retention capacity or the 
wettability of the products  (‘water retention polymers’) .  
This delegated Regulation sets out biodegradability criteria for coating agents  and water 
retention polymers, based on the conclusion of an external study2.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Member States have been 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 20163 . 
Details of these consultations can be found in the minutes of the meetings held on 24 October 
2022, 18-19 April 2023 and 15-16 April 2024 , 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.  [to fill in ] 
The draft delegated Regulation has been published for feedback on the Better Regulation 
portal [to fill in ].  
The draft delegated Regulation has also been notified based on Article 2(9)(2) of the 
Agreement on Technical Barriers to Trade and no comments hav e been received  [to be 
confirmed ].  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delegated act amends  Annexes II and III to Regulation (EU) 2019/1009. The legal basis 
of this delegated act is Article 42(1) of Regulation (EU) 2019/1009.  
                                                 
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.  
2  Study to assess biodegradability criteria for polymers used in EU fertilising products as coating agents 
or to increase w ater retention capacity or wettability and of mulch films. ISBN 978 -92-68-05051 -7; 
doi:10.2873/23399 . 
3 OJ L 123, 12.5.2016, p. 1.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards biodegradability criteria for coating agents and water retention polymers  
(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 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 2003/20031, 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. Pursuant to the requirements for Component Material 
Category 9 in Annex II to that Regulation, EU fertilising products may contain 
polymers to control the release of nutrients (‘coating agents ’), to increase the water 
retention capacity or wettability of the EU fertilising product (‘water retention 
polymer s’) or as binding materials . Coating agents are used in particular in the 
production of controlled release fertilisers. Their purpose is to s lowly  and timely  
release nutrients to plants and thus, reduce nutrients leaching. The use of such 
products is very important to reach the target set out in the Commission 
Communication on the Farm to Fork Strategy2 to reduce nutrient losses by at least 
50 %, while ensuring that there is no deterioration in soil fertility.  Water retention 
polymers may be used in other categories of EU fertilising products, too, such as soil 
improvers and growing media. They directly contribute, among others, to a sustainable  
use of water in agriculture. Polymer -based binding materials may be used in growing 
media . Such products are not to be used in contact with soils.   
(2) The ubiquitous presence of tiny fragments of synthetic or chemically modified  natural 
polymers, which are i nsoluble in water, degrade very slowly and can easily be 
ingested by living organisms, raises concerns about their general impact on the 
environment and, potentially, on human health. That is particularly valid for polymers 
intentionally added to EU fertil ising products which are subsequently released to the 
environment. To address this general concern, t he Commission adopted Regulation 
(EU) 2023/20553 which  introduce s a general restriction  in Regulation (EC) No 
                                                 
1 OJ L 170, 25.6.2019, p. 1 , ELI: http://data.europa.eu/eli/reg/2019/1009/oj . 
2 Communication of the Commission on ‘A Farm to Fork Strategy for a fair, healthy and 
environmentally -friendly food system’ (COM (2020 )381 final of 20  May 2020 ).  
3 Commission Regulation (EU) 2023/2055 amending Annex XVII to Regulation (EC) No 1907/2006 of 
the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards synthetic polymer microparticles  (OJ L 238, 27.9.2023, 
p. 67 , ELI: http://data.europa.eu/eli/reg/2023/2055/oj ).   
EN 3  EN 1907/2006 of the European Parliament and of t he Council4 of placing on the market of 
synthetic polymer microparticles . Some types of polymers (such as natural polymers 
which are not chemically modified) and polymers which meet specific 
biodegradability or solubility criteria are not concerned by the general restriction and 
may continue to be placed on the market.  
(3) Regulation (EU) 2019/1009 sets out an obligation for the Commission to assess by 16 
July 2024 the biodegradability c riteria for coating agents and water retention polymers 
used as component materials in EU fertilising products . Therefore, EU fertilising 
products are excluded from the scope of th at general restriction  in Regulation (EC) No 
No 1907/2006 .   
(4) The Commission assessed with the support of an external study the biodegradability 
criteria for coating agents and water retention polymers and test methods to verify 
compliance with those criteria  (‘the study’)5.  
(5) The study built a tool to predict the biodegradability b ehavior of polymers by using a 
mathematical model and showing the correlation between biodegradability under test 
conditions and natural environments representative of the different regions  of the 
Union . Thus, the study  assessed various factors such as soil temperature, soil pH, 
water content in soil, water temperature and other factors linked to the polymer 
characteristics (chemical structure, crystallinity, surface and thickness).  The study put 
forward proposals concern ing the biodegradability criteria in soils and in water.  
(6) The biodegradability criteria should be laid down both for soil (the main compartment , 
where the products are applied) and aquatic (in case of leac hing or other accidental 
presence in surface water  bodies ) environments .  
(7) As regards biodegradation in soils, only polymers which can reach the ultimate 
degradation or minerali sation within 48 months after the functionality period  should 
be allowed as component materials.  To reduce the testing period, an accelerated 
testing me thod should be permit ted. The study showed an adequate correlation 
between real life conditions and temperature s higher that 25°C which is the 
temperature used in testing conditions .  Testing at a higher temperature such as 37°C 
accelerate s biodegradation, while it is still considered acceptable in  terms of 
microbiology and environment -dependent factors  in real life conditions . The results 
obtained by the soil tool developed in the study showed that the testing period could 
be redu ced in specific cases . Therefore, an accel erated testing at 37°C under specific 
conditions should be introduced as an alternative option to demonstrate 90% ultimate 
degradation or mineralisation.  
(8) The biodegradability criteria for aquatic environments  should  take into account  both 
the function of the polymer and the available testing methods . On the function  of the 
polymer,  the coating agents  or water retention  polymers are to release nutrients in soils 
                                                 
4  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of C hemicals (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/EE C, 93/67/EEC, 93/105/EC and 
2000/21/EC  (OJ L 396, 30.12.2006, p.1 , ELI: http://data.europa.eu/eli/reg/2006/1907/2014 -04-10). 
5 Study to assess biodegradability criteria for polymers used in  EU fertilising products as coating agents 
or to increase water retention capacity or wettability and of mulch films , ISBN 978 -92-68-05051 -7; 
doi:10.2873/23399 .   
EN 4  EN slowly  or to increase the water retention , for 6-9 months in average . So, th ose 
polymers are designed to slowly degrad e when exposed to various factors in soils, 
such as water. The biodegrada tion in soil which unavoidably occurs during that 
functionality period should be limited so that the polymer can st ill fulfil its function. 
As regards the available test methods  for biodegradability in water, they are reliable 
during  a period of 12 months . Thus, s tringent criteria  for aquatic environment as set 
out in Delegated Regulation (EU) 20 23/2055 would negatively affect the primary 
function of soil -biodegradable  coating agents and water retention  polymers . Therefore, 
biodegradability in aquatic environments  should be set out at a lower  level during the 
testing period  but still high enough to ensur e that there would not be an accumulation 
of polymers in aquatic environments.  It is assumed that the biodegradation process 
will continue after the 12-month testing period and will reach the 90  % within 48 
months after the functionality period. While that ultimate degradation cannot be 
proved with the existing test methods, it is nevertheless a safe assumption as the 
material already proved a biodegradation potential and it will continue to be exposed 
to the same environmental factors .   
(9) In real life conditions , coating agents and water retention polymers are contained in 
EU fertilising products to be applied to soil. They are not supposed  to reach aquatic 
environments . While leaching cannot be totally excluded,  the potential risks to the 
aquatic envir onment are reduced because the polymers concerned would reach water 
bodies only after having already started the degradation in soils  due to factors such as 
erosion and ultraviolet radiation . To further limit the potential risks, a labelling 
requirement sh ould be set out, warning  end-users not to use the product  close to 
surface  water bodies  and to maintain  buffer strips .   
(10) To ensure equal conditions for competition  and in accordance with the requirements 
for the criteria set out in Article 42(6) of Regulation (EU) 2019/1009 , the test methods 
to prove compliance with the biodegradability criteria should be listed. Such test 
methods  are set out in European or international standards and are thus  reliable and 
reproducible .  
(11) As regards polymer s used as b inding materials , the Commission received information 
on the use of biodegradable polymers as binding materials. If such polymers fulfill the 
conditions set out for polymers belonging to CMC 1 , then they do not r aise 
environmental concerns and the specific  labelling requirements concerning the use and 
the disposal of EU fertilising products containing such polymers are not justified and 
should not apply.  
(12) Regulation (EU) 2023/2055 is to start applying to national fertilising products from  17 
October 2028. For coherence reasons and to allow sufficient time to adapt to the 
requirements introduced by this Regulation  concerning the biodegradability of 
polymers , the same transitional period should apply . 
 
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.    
EN 5  EN 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 . 
Annex I  and point 1 of Annex II  shall  apply from  17 October 2028 .  
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 Le yen