EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2019/1009 of the European Parliament and of 
the Council as regards the polymers in Component Material Category 11  
(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. EU fertilising products may contain polymers, in the conditions laid down in 
Component Material Categories  (CMCs)  8 and 9  in Annex II to the Regu lation . The 
Commission has to assess biodegradability criteria for certain polymers  belonging to CMC 9  
control ling the release of nutrients ( ‘coating agents ’) or increas ing the water retention 
capacity or the wettability of the products  (‘water retention  polymers ’).  
On 23 June 2021, the Commission adopted Delegated Regulation (EU) 2021/17682 adding 
certain categories of polymers in Component Material Categories 1 and 11. Such polymers 
are normally used as technical additives, to increase the agronomic va lue or the safety of the 
products. In order to identify which polymers do not cause any environmental concern  and 
therefore include them in CMCs 1 and 11 , the Commission took into account the scientific 
opinion issued by the Risk Assessment Committee  and t he Committee for Socio -Economic 
Analysis3  of the European Chemical Agency in accordance with Regulation (EC) No 
1907/20064 on intentionally added microplastic particles to consumer or professional use 
products of any kind.  
Based on the same scientific opi nion, the Commission adopted Regulation (EU) 2023/20555 
which introduces a general restriction  in Regulation (EC) No 1907/2006  of placing on the 
market of s ynthetic polymer microparticles . Specific categories of polymers (such as natural 
polymers not chemi cally modified) and polymers meeting certain biodegradability or 
solubility criteria are not covered by the general restriction and may continue to be placed on 
the market.  
EU fertilising products are excluded from the scope of that restriction , pending  the outcome of 
the assessment on biodegradability criteria for coating agents and water retention  polymers.  
The polymers which may be used as materials belonging to CMC 11 should follow the same 
general rules set out in Delegated Regulation (EU) 2023/2055.  
                                                 
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 ferti lising 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  Commission Delegated Regulation (EU) 2021/1768 of 23 June 2021 amending, for the purpose of its 
adapt ation 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.  
3  RAC ECHA. 2 020. Opinion on an Annex XV dossier proposing restrictions on intentionally added 
microplastics (ECHA/RAC/RES -O -0000006790 -71-01/F).  
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 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 Coun cil 
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.  
5 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 2  EN 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 20166 . 
Details of these consultations can be found in the minutes of the meetings held on 27-28 
November  2023 and 15 -16 April 2024 , as well as in the various position papers of int erested 
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 f or 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 have been received  [to be 
confirmed ].  
3. LEGAL  ELEMEN TS OF THE  DELEGATED  ACT  
The delegated act amends Annex II to Regulation (EU) 2019/1009. The legal basis of this 
delegated act is Article 42(1) of Regulation (EU) 2019/1009.  
                                                 
6 OJ L 123, 12.5.2016, p. 1.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2019/1009 of the European Parliament and of 
the Council as regards the polymers in Component Material Category 11  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Trea ty 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 related to the component material 
categories ('CMC s') 8 and 9 laid down in Part II of Annex II to this Regulation, EU 
fertilising products may contain certain polymers.   
(2) The ubiquitous presence of tiny fragments of synthetic or chemically modified natural 
polymers, which are insoluble 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 pol ymers 
intentionally added to EU fertilising products which are subsequently released to the 
environment.  
(3) Therefore, Regulation (EU) 2019/1009 set out an obligation for the Commission to 
assess by 16 July 2024 the biodegradability criteria of two categorie s of p olymers 
belonging to CMC 9: polymers control ling the water penetration into nutrient particles 
and thus the release of nutrients (‘coating agents’)  and polymers increas ing the water 
retention capacity or wettability of the product (‘water retention p olymer s’).   
(4) On 23 June 2021, the Commission adopted Delegated Regulation (EU) 2021/17682 
adding new categories of polymers in Component Material Categories 1 and 11. Such 
polymers are normally used as technical additives, to increase the agronomic value or 
the safety of the products. In order to identify which polymers do not cause any 
environmental con cern and therefore should be include d in CMCs 1 and 11 , the 
Commission took into account the scientific opinions issued by the Risk Assessment 
                                                 
1 OJ L 170, 25.6.2019, p. 1 , ELI: http://data.europa.eu/eli/reg/2019/1009/oj . 
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) 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.   
EN 4  EN Committee3 and the Committee for Socioeconomic Analysis of the European 
Chemical Agency in accordance with Regula tion (EC) No 1907/2006 of the European 
Parliament and of the Council4, on intentionally added microplastic particles to 
consumer or professional use products of any kind.  Thus, only natural polymers, 
which have not been chemically modified, biodegradable p olymers or soluble 
polymers may be used as materials belonging to CMCs 1 or 11.  
(5) Subsequently, the  Commission adopted Regulation (EU) 2023/20555 which introduces 
a general restriction in Regulation (EC) No 1907/2006 of placing on the market of 
synthetic po lymer microparticles  (‘the general restriction’) . Certain categories of 
polymers and polymers meeting biodegradability or solubility criteria set out in 
Regulation (EC) No 1907/2006 are excluded from the general restriction.  
(6) EU fertilising products are ex cluded from the scope of the general restriction, waiting 
for the outcome of the assessment on biodegradability criteria for coating agents and 
water retention polymers. However, the requirements for polymers belonging to CMC 
11 typically used as technical additives should be aligned to the requirements for 
polymers exempted from the general restriction. Firstly, the materials belonging to 
CMC 1 1 are already subject to some provisions of Regulation (EC) No 1907/2006, 
specifically  adapted to their use as component materials in EU fertilising products. 
Secondly, the polymers which may be used as materials belonging to CMC 1 1, 
typically technical additives, such as ant i-dusting or anti -caking agents, are not 
fulfilling a specific fun ction during a certain period after their application to soils, like 
coating agents and water retention polymers , they do not have to slowly degrade  and 
there is no justification to introduce or maintain specific biodegradation rules  for them . 
Thirdly , the general restriction in Regulation (EC) No 1907/2006 applies to  similar 
polymers in  national fertilising products, except for coating agents or water retention 
polymers which are to meet  the same criteria as the ones to be laid down in accordance 
with Regu lation (EU) 2019/1009. Aligning the requirements for materials belonging to 
CMC 1 1 to those in Regulation (EC) No 1907/2006 is thus needed both to ensure 
coherence by  applying the same rules to similar materials contained in either 
harmonized or non-harmon ised products , and to achieve the objectives pursued by 
introducing the general restriction in Regulation (EC) No 1907/2006 , which  could  be 
jeopardized by maintaining more lenient rules in Regulation (EU) 2019/1009.  
(7) Regulation (EU) 2019/1009 should theref ore be amended accordingly.   
(8) 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, the same trans itional period should apply ,    
                                                 
3  RAC ECHA. 2020. Opinion on an Annex XV dossier proposing restrictions on intentionally added 
microplastics (ECHA/RAC/RES -O -0000006790 -71-01/F).  
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 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.  
5 Commission Regulation (EU) 2023/20 55 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, 27.9.202 3, 
p. 67 , ELI: http://data.europa.eu/eli/reg/2023/2055/oj ).   
EN 5  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Point 1 in s ection ‘CMC 1 1: BY-PRODUCTS WITHIN THE MEANING OF DIRECTIVE 
2008/98/EC’  in Part II of Annex II to Regulation (EU) 2019/1009 is amended as follows:  
(1) point ( b) is replaced by the following:  
‘(b) polymers, other than:  
(i) polymers that are the result of a polymerisation process that has taken place 
in nature, independently of the process through which they have been extracted 
and which are not chemically modified substances within the meaning of 
Article  3, point (40), of  Regulation (EC) No  1907/2006 ;  
(ii) polymers that are degradable in accordance with Appendix 15 of Annex 
XVII to Regulation (EC) No 1907/2006;  
(iii) polymers that have a solubility greater than 2 g/L in accordanc e with 
Appendix 16 of Annex XVII to Regulation (EC) No 1907/2006 ; 
(iv) polymers that do not contain carbon atoms in their chemical structure,’;  
(2) the following point ( ba) is inserted:  
‘(ba) polymers covered by CMC 8 and CMC 9,’.  
  
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  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