EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2024) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
Commission Delegated Regulation  
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as 
regards the inclusion of mulch films in Component Material Category 9   EN 1  EN ANNEX  I 
 
Part II, s ection ‘CMC 9: POLYMERS OTHER THAN NUTRIENT POLYMERS‘ ,  of Annex 
II to Regulation (EU) 2019/1009 is amended as follows:  
(1) the following point 1a is inserted:  
‘1a. An EU fertilising product belonging to PFC 3 may contain a polymer in the form of a 
mulch film.’;  
(2) the following point 2a is inserted:  
‘2a. The polymer in a mulch film referred to in point 1a shall comply with the 
biodegradability criteria set out in Appendix 2 to this Annex.’;  
(3) in point 3 , the introductory  wording  is replaced by the following:  
‘For the polymers referred to in point 1(a) and (b) and in point 1a, neither the polymer, nor its 
degradation by -products, shall show any overall adverse effect on animal or plant health, or 
on the environment, under reasonably foreseeable conditions of use in the EU fertilising 
product. The polymers re ferred to in point 1(a) and (b) and point 1a shall pass a plant growth 
acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil 
micro -organisms as follows:’;  
(4) the following  point 4  is added:  
‘4. The polymer referred to in point 1a shall pass an earthworm chronic toxicity test so that:  
(a) after an incubation period of 28 days, the observed mortality and the biomass 
of surviving adult earthworms in a soil exposed to the test material shall not 
differ by more than 10 % compared to those from the corresponding blank soil 
not exposed to the test material;  
(b) after an incubation period of 56 days, the observed number of offspring in a 
soil exposed to the test material shall not differ by more than 10% compared to 
those fr om the corresponding blank soil not exposed to the test material.  
As regards point (a) of this point, the results shall be considered to be valid, if:  
(i)  the percent mortality observed in the control (i.e. blank soil) is less than 10 %; and  
(ii)   the av erage loss of biomass (mean weight) of the worms in the blank soil does not 
exceed 20 %.  
As regards point (b) of this point, t he results shall be considered to be valid, if  the average  
loss of offspring in the control (i.e. blank soil) is less than 20 %.’; 
(5) the following Appendi x 2 is added:  
‘Appendix 2  
Biodegradability criteria of polymers for mulch films referred to in section CMC 9, 
point 1a  
1. The biodegradability of polymers in mulch films referred to in section CMC 9, point 
1a, shall be demonstrated in th e following environmental compartments:  
(a) compartment  1: soil;  
(b) compartment  2: fresh, estuarine or marine water , or water sediment interface . 
2. The polymer shall achieve:  EN 2  EN (a) in compartment 1:  
(i) ultimate degradation of at least 90  % relative to the degradation of the 
reference material within 24 months plus the functionality period of the 
product as indicated on the label; or  
(ii) mineralisation of at least 90  %, measured as evolved CO 2, over a maximum 
of 24 months plus the functionality period of the product as indicat ed on the 
label ; 
(b) in compartment  2, ultimate degradation of at least 30  % relative to the degradation of 
the reference material in 12 months.  
3. To demonstrate the biodegradability criteria in point 2(a), one of the following test 
methods shall be used:  
(a) EN ISO 17556:2019. Plastics – Determination of the ultimate aerobic 
biodegradability of plastic materials in soil by measuring the oxygen demand in a 
respirometer or the amount of carbon dioxide evolved;  
(b) ISO/CD 23517:2021. Plastics – Soil biodegradable materi als for mulch films for use 
in agriculture and horticulture;  
(c) ASTM D5988 -96:2018. Standard Test Method for Determining Aerobic 
Biodegradation in Soil of Plastic Materials.  
4. When  there is no phase transition (glass transition or melting transition) between 
25°C and 37°C, the temperature during testing in accordance with points 3(a), (b) 
and (c) may be  adjusted at 37oC. 
In such a case , the relevant criterion in point 2(a) shall be considered as being 
demonstrated if the polymer achieve s: 
(a) at least 45% ultimate degradation  or minerali sation as referred to in point 2(a) in a 
separate test at 25°C in 10 months, whereby degradation or minerali sation shall be 
progressing, and the plateau phase shall not have been reached, unless the 
degradation  or mineralisa tion is at least 90%; and   
(b) ultimate  degradation of at least 90  % relative to degradation of the reference material 
within 10 months plus the functionality period of the product as indicated on the 
label;  
(c) mineralisation of at least 90  %, measured as evolve d CO 2, over a maximum of 10 
months plus the functionality period of the product as indicated on the label.  
 
5. To demonstrate the biodegradability criteria in point 2(b), one of the following test 
methods shall be used:  
(a) EN/ISO 14851:2019 Determination of the  ultimate aerobic biodegradability of 
plastic materials in an aqueous medium. Method by measuring the oxygen demand in 
a closed respirometer;  
(b) EN/ISO 14852:2021  Determination of the ultimate aerobic biodegradability of 
plastic materials in an aqueous mediu m. Method by analysis of evolved carbon 
dioxide;  EN 3  EN (c) ASTM D6691:2018 Standard Test Method for Determining Aerobic Biodegradation 
of Plastic Materials in the Marine Environment by a Defined Microbial Consortium 
or Natural Sea Water Inoculum ; 
(d) EN/ISO 19679:2020 Plastics - Determination of aerobic biodegradation of non -
floating plastic materials in a seawater/sediment interface - Method by analysis of 
evolved carbon dioxide ; 
(e) EN/ISO 18830:2017 Plastics - Determination of aerobic biodegradation of non -
floating plast ic materials in a seawater/sandy sediment interface - Method by 
measuring the oxygen demand in closed respirometer . 
6. Polymers may be tested in any of the following forms:  
(a) in the form of the film placed on the market;  
(b) in a powder form of the  milled  film.  
7. The following materials may be used as reference materials:  
(a) positive controls: biodegradable materials such as micro -crystalline cellulose 
powder, ashless cellulose filters or poly -β-hydroxybutyrate;  
(b) negative controls: non -biodegradable polymers such as polye thylene or 
polystyrene.’ . EN 4  EN ANNEX I I  
In Part I, point 1 , of Annex III to Regulation (EU) 2019/1009 , the following point (fa) is 
inserted : 
‘(fa) for products belonging to PFC 3 containing a polymer referred to in Part II, section CMC 
9, point 1a, of Annex II : 
(i)  the time period following use during which the soil improver will fulfil its function (the 
‘functionality period’), which shall not be longer than the period between two applications in 
accordance with the use instructions referred to in point (d) of this point;  
(ii.) an instruction not to apply the product within at least 3 meters of surface water bodies, 
while respecting any national rules setting more stringent requirements;  
(iii) an inst ruction  to incorporate in soil the product after its functionality  period and maintain 
it buried; ’.