EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
 
 
(Text with relevance for the UK in respect of Northern Ireland)  
(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  
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. Some of t hese amendments are 
necessary in order to achieve consistency with other pieces of EU legislation or secure  the 
high level of protection that  Regulation (EU) 2019/1009 aims to achieve. Others are necessary 
to avoid unintended situations in which important categories of fertilising products would 
inadvertently be excluded from the harmonisation rules for not being able to comply with 
some technical provisions. By securing the desired level of protection and removing undesired 
market access barriers, t he amend ments will thus facilitate internal market access and free 
movement for agronomically efficient fertilising products which are subject to significant 
trade on the internal market and which do not present a risk to health, safety or the 
environment , in accordance with the Commission empowerment in Article 42(1 ) of 
Regulation (EU) 2019/1009 . 
2. CONSULTATIONS  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 o f 
13 April 20163 . 
Details of these consultations can be found in the minutes of the meetings held on 7 
November 2019, 25 June 2020 and 24 November 2020 , 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.  
                                                 
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 OJ L 123, 12.5.2016, p. 1.   
EN 2  EN The draft delegated Regulation has been published for feedback on the Better Regulation 
portal. [details o n the replies received to be added once the consultation is done]  
The draft delegated Regulation has also been notified based on Article 2( 9)(2) of the 
Agreement on Technical Barriers to Trade. [to add if we receive any comments]   
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 basis of this delegated act is Article 42(1) of Regulation (EU) 
2019/1009.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
 
 
(Text with relevance for the UK in respect of Northern Ireland)  
(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 an d 
repealing Regulation (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 material 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) Regulation (EU) 2019/1009  empowers the Commission to amend Annexes I (partly), 
II, III and  IV thereto . 
(3) 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 provisions in the annexes to Regulation  (EU) 2019/1009 . Some of th ose 
amendments are necessary in order to improve consistency with other p ieces of U nion 
legislation , which would  facilitate internal market access  and the free movement  of 
safe and agronomically efficient fertilising products . Some amendments are necessary  
to secure the high level of protection that Regulation (EU) 2019/1009 aims to achieve , 
thereby  ensuring  that EU fertilising products having access to the internal market  by 
virtue of that Regulation do not present a risk to health, safety or the environment . 
Other  amendments  are necessary in order  to avoid situations in whic h significant  
categories of fertilising products would inadvertently be excluded from the 
harmonisation rules . Those amendments will secure internal  market  access for 
fertilising products that are agronomically efficient, safe, and already widely traded on 
the market .  
                                                 
1 OJ L 170, 25.6.2019, p. 1.   
EN 4  EN (4) Regulation (EU) 2019/1009 lays down  rules for  EU fertilising product s containing  a 
substance with maximum residue limit values for food and feed laid down  in 
accordance with  Council Regulation (EEC) No 315/932, in Regulation (EC) No 
396/2005 of the European Parliament and of the Council3, in Regulation (EC) No 
470/2009 of the European Parliament and of the Council4, or in Directive 2002/32/EC 
of the European Parliament and of the Council5. The manufacturer is oblig ed to 
provide use instruction s to ensure that the intended use of the EU fertilising product 
does not lead to the exceedance of the maximum limit val ues for food and feed . In 
addition, the manufacturer is to include in the technical documentation  the results of  
calculation s that prove compliance with this requirement . In the discussions on how to 
implement this obligation, it has become clear that  it is impossible for manufacturers 
to compl y there with, thus preventing agronomically efficient, safe, and already widely 
traded  fertilising  products from  passing the conformity assessment and access ing the 
internal market under  Regulation  (EU) 2019/1009 . Those obligations should therefore 
be replaced by obligations that are more proportionate and im plementable in t wo 
respects . 
(5) Firstly, the exceedance of those maximum limits  or levels  in crops  can be  prevented  
by providing correct information to the end-user on the label. Consequently, 
Regulation (EU) 2019/1009 should be amended so as to impose  an obligation upon the 
manufacturer  to inform  the end -user whenever the EU fertilising product contains a 
component material which, if placed on the market as food or feed,  exceed s the 
maximum limits or levels set in Regulation s (EC) No 470/2009  or (EC) No 396/2005, 
in accordance with Regulation  (EEC) 315/93 , or in Directive 2002/32/EC. 
Furthermore, in order to ensure  a high level of protection of human health, animal 
health and  the environment in relation to feed additives , Regulation (EU) No 
1831/2003 of the European Parliament and of the Counci l6 should be added. In this 
way, the end-user will be in a position to take all necessary measures to ensure that the 
crop is compliant with the food and feed rules.    
(6) Second ly, additional measures are needed  regarding  some pharmacologically active 
substa nces already covered by Regulation (EC) No 470/2009 . The approach should be 
different depending on whether it is an allowed substance listed in Table 1 in the 
Annex to Commission Regulation (EU) No 37/20107, and for which a maximum 
residue limit may have been set , or it is a non -allowed substance with a reference point 
                                                 
2 Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for 
contaminants in food (OJ L 37, 13.2.1993, p. 1).  
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 Febr uary 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
4 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2 009 laying 
down Community procedures for the establishment of residue limits of pharmacologically active substances in 
foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 
2001/82/EC of the European Parliament a nd of the Council and Regulation (EC) No 726/2004 of the European 
Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).  
5 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable 
substances in animal feed (OJ L 140, 30.5.2002, p. 10).  
6 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).  
7 Commission Regulation (EU) No 37/2010 of 22 December 2009 o n pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 
20.1.2010, p. 1).   
EN 5  EN for action laid down in Commission Regulation (EU) 2019/18718. Residues of an  
allowed substance may be present in an EU fertilising product only if the said 
substance is listed in Table I in the Annex to Regulation (EU) No 37/2010. However, a 
non-allowed pharmacologically active substance, which is more hazardous  to the 
health of the consumer when present in foodstuff,  should not be present abov e its 
reference point of action in an EU fertilising product either.  
(7) An EU fertilising product may also contain active substances within the meaning of 
Regulation (EC) No 1107/2009  of the European Parliament and of the Council9. As 
Regulation (EU) 2019/100 9 does not cove r plant protection products , it should be 
made clear in the text of that regulation that an EU fertilising product  contain ing an 
active substance  must  not have a plant protection function within the meaning of 
Regulation  (EC) No 1107/2009 . This clarification is needed to ensure consistency with 
Regulation (EC) No 1107/2009 , which will facilitate the implementation of the 
harmonisation rules both by economic operators and by national authorities, thereby  
facilitating  access to the internal ma rket based on Regulation (EU) 2019/1009.  
(8) Regulation (EU) 2019/1009  contains  an exhaustive  list of typologies for a straight 
inorganic micronutrient fertiliser, as well as their corresponding description s and 
minimum micronutrient content. For micronutrient salt fertiliser, 10% by mass of the 
fertiliser consist s of a water -soluble micronutrient. However, there are fertilisers based 
on carbonate or phosphate  salts that have  micronutrients that are not water -soluble. 
This does not affect their performance as fertilisers or the uptake of nutrients in the 
crop. Such micronutrient salt fertilisers should therefore be allowed access to the 
internal market  by removing  the water -soluble condition.   
(9) Regulation (EU) 2019/1009  lays down limit values for contaminants , including nickel,  
in a growing medium,  which is an EU fertilising product other than soil in situ , the 
function of which is for plants or mushrooms to grow in . Regulation (EU) 2019/1009 
sets harmonisation rules for this type of fertilising product. There are already 
numerous  kinds of growing media on the market , based on national rules  and with 
very divers e characteristics, which could be candidates for becoming  EU fertilising 
products. However, the limit value for nickel set out in Regulation (EU) 2019/1009 for 
all types of growing media creates difficulties  for s ome g rowing media contain ing 
solely constituents  of mineral origin . Such products  are niche products  that compl y 
with the prin ciples of the circular economy and already satisfy the EU Ecolabel criteria 
established for growing media by Commission Decision (EU) 2015/209910. In th is 
Decision, a distinction is made between mineral growing media and other categories 
of growing media as regards the methods of determining the content of contaminants , 
including nickel . Thus, for all growing media except mineral growing media, the total 
content of the contaminant is to be determined, while for mineral growing media only 
the bioavailable con tent is to be determined. This distinction is justified by the fact 
that mineral growing media are usually manufactured at high temperatures, producing 
a strong chemical bond of contaminants  with the structure of the mineral  constituents , 
                                                 
8 Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non -
allowed pharmacologically active substances present in food of animal origin and repealing Decision 
2005/34/EC (OJ L 289, 8.11.2019, p. 41).  
9 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC 
and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).  
10 Commission Decision (EU) 2015/2099 of 18 November 2015 establishing the ecological criteria for the 
award of the EU Ecolab el for growing media, soil improvers and mulch (OJ L 303, 20.11.2015, p. 75).   
EN 6  EN limiting the exte nt to which such contaminants are biologically available . However, 
such a distinction is not made in Regulation (EU) 2019/ 1009.  Based on  the 
information available, while mineral growing media available on  the market would 
comply with the limit value set  for nickel in Regulation (EU) 2019/1009 if only the 
bioavailable content of the contaminant is to  be determined, they cannot comply with 
the same limit if the total content is to be determined, as is currently required. It is 
therefore important to ensure  consistency between the requirements for the CE 
marking of th ose products based on Regulation (EU) 2019/1009 and applying the 
Ecolabel , in order to  avoid the unintended situation in which products safe for  the 
environment and therefore  having an  Ecolabel would be outside the scope of the 
harmonisation rules.  Thus, t he limit value for nickel laid down  in Annex I to 
Regulation (EU) 2019/1009 should apply only to  the bioavailable content  for mineral 
growing media .  
(10) As a safeguard measure, th at rule should apply only where th e use of th ose products is 
limited to professional use in horticultural applications, green roofs or green walls. 
This would ensure a better handling and a higher recovery rate of the used growing 
media , with real possibilities of recycl ing the materials after use. In addition, t he 
manufacturer should also collaborate with the user to ensure the safe disposal of the 
products once they are no longer in use. Furthermore, the product should not enter into 
direct contact with the soil, so as not to contribute to the accumulation of contaminants 
therein.  
(11) EU fertilising products may contain only component materials compliant with the 
requirements laid down for one of the component material categories in Annex II to 
Regulation (EU) 2019/1009. Fertilising products, in particular fertilisers, often contain 
polymer -based technical additives, which are important to ensure their efficiency and 
safe use. Those additives  are not covered by any of the existing component material 
categories . However, fertilisers containing them are covered by the harmonisation 
rules in Regulation  (EC) No 2003/2003  of the European Parliament and of the 
Council11.  Such technical additives are, for instance, anti -caking agents preventing the 
formation of lumps, and anti-dusting agents  preventing dust emissions from the 
fertilising product during its application. Anti-caking agents are essential for the 
nutrient use efficiency as without such agents , the fertiliser would not spread evenly 
and therefore the end -user would apply more fertiliser to make sure  that it reaches all 
plants. Anti -dusting agents are also very important for protecting users’ health. 
Polymers that do not cause any environmental concern  should therefore be included 
among the component materials all owed in fertilising products under Regulation (EU) 
2019/1009.  This would ensure that significant  categories of products with an improved 
agronomic efficiency and safety  continue to have access to the internal marke t.  
(12) In order to identify which polymers  do not cause any environmental  concern , it is 
appropriate to refer to the scientific opinion s issued  by the Risk Assessment 
Committee12 and the Committee for Socio -economic  Analysis of the European 
Chemical Agency in accordance with  Regulation (EC) No 1907/2006 of the European 
                                                 
11 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 ). 
12 RAC ECHA. 2020. Opinion  on an Annex XV dossier proposing restrictions on  intentionally added 
microplastics  (ECHA/RAC/RES -O -0000006790 -71-01/F) .  
EN 7  EN Parliament and of the Council13, on intentionally added microplastic particles  to 
consumer or professional use products of any kind .   
(13) By including these categories of polymers in CMC 1 (Virgin material substance s and 
mixtures) and CMC 11 (By -products within the meaning of Directive 2008/98/EC  of 
the European Parliament and of the Council14), it is also ensured that those polymers 
will be registered under Regulation (EC) No 1907/2006 with a dossier including a 
safety report for their use as a fertilising product. This would ensure that a detailed 
assessment of any risks from the use of these additives in fertilising products would be 
carried out , and that the fertilising products granted internal market access  under  this 
amendment  are thus safe for human health and the environment .   
(14) Fertilisers with micronutrients may contain chelating or complexing agents, which are 
substances  intended to enhance the long-term availability of micronutrients to plants.   
(15) Regulation (EU) 2019/1009 requires fertilising products containing chelating agents to 
remain stable in standard Hoagland solution at pH 7 and 8 for at least three days, to 
ensure that the micronutrients are slowly released to plants. The composition of 
agricultural soils and variations in pH can disturb the stability of these products. New 
technical progress allows to assess potential interferences and to establish a  pH range 
where products are stable for agricultural purposes.  Based on the above, a product may 
be st able at a pH range other than pH 7 and 8, and still fulfil  its purpose of ensuring 
long-term availability of micronutrients. Therefore, Regulation (EU) 2019/1009 
should be amended to allow such products to be stable within a different pH range. In 
this way , the harmonisation rules would apply to more products, which  slowly release 
micronutrients to plants and thus reduce the leaching of nutrients in soils. As an 
additional measure, the pH range in which the EU fertilising products are stable should 
be indic ated on the label to ensure that correct information is provided to the end -user.  
(16) Regulation (EU ) 2019/1009 requires  the declaration of the percentage of each 
micronutrient chelated by each chelating agent and of each micronutrient complexed 
by each comple xing agent, as applicable. Products with micronutrients may contain a 
mixture of chelating agents, or complexing agents, or both. In such cases,  the 
analytical methods  available  cannot support the determination of the exact percentage 
of each micronutrient  chelated or complexed by each individual agent . Thus, 
Regulation (EU) 2019/1009 should be amended in order to allow the manufacturer to 
comply with these labelling requirements , thereby facilitating their access to the 
internal market .  
(17) Some fertilising products , such as growing media , use peat as a main component. 
Encouraging the use of alternatives to peat is important in the fight against climate 
change, especially for the prevention of carbon loss and greenhouse gas emissions, as 
well as the conservat ion of fragile ecosystems. Plant fibr es could be used to replace 
partially peat in growing media. However, to upgrade the potential of untreated plant 
fibres, these have to be transformed into fibres of finer particles as this improves their 
degree of biod egradability , their interaction with nutrients and water retention . 
                                                 
13 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).  
14 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 8  EN Conditioning of the raw plant fibres using different physical pre -treatments for the 
purpose of fiberisation should be included in the exhaus tive list of treatments in CMC 
2 (Plants, plant  parts and plant extracts ). As a safeguard measure, certain restrictions  
should be added  to the processing methods, such as maximum temperature and the 
prohibition of additives except water . 
(18) CMC 3 (Compost ) and CMC 5 (Digestate other than fresh crop digest ate) lay down an 
exhaustive list of input materials that can be used. That list includes derived products 
referred to in Article 32 of Regulation (EC) No 1069/2009 of the European Parliament 
and of the Council15 and animal by -products  which can be considered living or dead 
organisms, in cases where an  end point in the manufacturing chain has been 
determined in accordance with the third subparagraph of Article 5(2) of that 
Regulation.   
(19) Regulation (EU) 2019/1009 lays down for the first time har monisation rules for 
compost and digestate  as component materials in EU fertilising products . These 
materials are nevertheless  present on the market , based on national rules. Currently, 
animal by -products  that cannot be considered living or dead organisms  (especially 
unprocessed manure)  are frequently  used as input materials  for compost and digestate.  
In this way,  such materials are transformed into fertilising products  with a net 
economic and environmental added value . The use of composted animal excrement , 
including poultry manure and composted farmyard manure, as well as digestate 
containing animal by -products co -digested with material of plant or animal origin is 
included in the exhaustive list of fertilisers, soil conditioners and nutrients allowed in 
organic farming in Annex I to Commission Regulation (EC) No 889/200816. It is 
therefore appropriate to grant access to the internal market to fertilising products 
containing compost or digestate with such animal by -products as input materials. This 
would als o ensure consistency with the input materials allowed in the recently 
introduced CMC 12 (Precipitated phosphate salts and derivates ), CMC 13 (Thermal 
oxidation materials and derivates), as well as CMC 14 (Pyrolysis and gasification 
materials).  
(20) CMCs 3 and 5 also exclude from their input materials living or dead organisms from  
the organic fraction of mixed municipal household waste. On the contrary, CMC s 12 , 
13 and 14 exclude from their input materials living or dead organisms out of the 
material s from mixed municipal waste , and not only household waste . The objective of 
those provisions is to encourage the separate  collection of waste in municipalities , by 
not providing opportunities for the use of mixed waste . The reasoning  is the same both 
if the waste is generate d by households or by restaurants or other operators  in 
municipalities . There is no reason to prohibit the use of only household mixed waste 
as input material  in compost and digestate. Theref ore, to ensure a coherent and 
stringent appro ach towards the recovery of mixed municipal  waste  and thus to 
                                                 
15 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 Regulation) (OJ L 
300, 14.11.2009, p. 1 ). 
16 Commission Regulation (EC) No  889/2008 of 5  September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No  834/2007 on organic production and labelling of 
organic produ cts with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 
1).  
EN 9  EN reinforce the protection of the environment,  it is necessary to align  the provisions in 
CMCs 3 and 5 with those in th e recently introduced  CMCs 12, 13 and 14.  
(21) Regulation (EU) 2019/1009 sets out an obligation for t he manufacturer  to list on the 
label all ingredients  above 5% by-product  weight. However, the  element on which the 
5% limit is applied should be adapted  to the properties and physical characteristics of 
the fertilising product concerned and thus a declaration of ingredients representing 5% 
of volume should be allowed.  Especially in case of products where the quantity is 
indicated by volume, listing the in gredients representing 5% of the volume is 
preferable as the relative ingredients’ weight by products weight is not always  known . 
This would f acilitate the access  of such products to the internal market . As regards the 
EU fertilising product  in liquid form , it is appropriate to label the ingredients above 5 
% by dry weight  as otherwise there might be situations in which only water would be 
listed as an ingredient . This would e nsure that products have access to the internal 
market based on  Regulation (EU) 20 19/1009 only if the user s are properly informed 
about the ir ingredients, so that they can use the product s safely .  
(22) The label of an organo -mineral fertiliser, a solid or liquid inorganic macronutrient 
fertiliser and an inorganic micronutrient fertiliser  is to list the names and chemical 
symbols of the declared micronutrients, followed by the names of their counter -ions. 
In some cases, the declarable level of micronutrients can be present naturally in the 
component materials  of EU fertilising products. Thi s is particularly the case for 
fertilisers  from  mined materials . Because of  their natural or igin, the names of the 
counter -ions for those micronutrients cannot always be determined  due to analytical or 
technical limitations. Therefore, the declaration of m icronutrients that are not 
intentionally added to the EU fertilising product  should be allowed , even if the 
corresponding co unter -ions cannot be determined.  Otherwise, inorganic micronutrient 
fertilisers from  mined materials could not be marketed under Reg ulation (EU) 
2019/1009 , as the manufacturer could not comply with this labelling requirement. In 
addition, d eclaring the micronutrient content in organo -mineral and inorganic 
macronutrient fertilisers without the corresponding counter -ions is beneficial  both to 
the end -user, who could adapt a fertilisation plan by taking into account also the 
micronutrient content, and to the environment,  as it could avoid over -fertilisation. The 
efficiency or safety of the fertiliser  is not affected by the exclusion of the counter -ions 
from the label.  
(23) The manufacturer of a solid inorganic macronutrient fertiliser is oblig ed to mention on 
the label the form of the physical unit , by reference to  one of the four different forms 
listed  in the Regulation , namely  powder, granules, prills and pellets. However, in some 
cases,  using only one of the above  specific forms is not possible,  as the physical form 
of the product combines  two of the four forms . Therefore, to allow the manufacturer  to 
comply with this labelling requirement, the physical unit description should not be 
limited to only one possible form , but should also allow the  use of a  combination  of 
forms . The physical unit definitions should cover all types of fertilisers and  should  not 
restrict the placing on the market of products  which otherwise comply with the 
requirements in Regulation (EU) 2019/1009 .  
(24) Regulation (EU) 2019/1009  sets tolerance  rules  for each PFC for the different values 
declared on the label.  Regulation (EU) 2019/1009  sets both negative tolerances (the 
actual value  should not go below the declared value reduced by the negative tolerance ) 
and positive tolerances (meaning that the actual value  cannot be higher than the 
declared value increased  by the respective tolerance). This is particularly important for 
the declaration of nutrients where, in order to avoid under - and over-fertilisation, the  
EN 10  EN manufacturer has to ensure that the nutrient content declared is neither below nor 
above the declared value plus the tol erance s.  
(25) Some of the tolerances set for inorganic fertilisers are very narrow given the  existing 
technical capacities. This is especially the case for declared nutrients where the content 
of the nutrient might be relatively low when compared to the whole product. A low 
nutrient content means that the deviation of its declared value is also small, as it is 
declared as a percentage of the nutrient content. Thus, the tolerances for some of the 
requirements for inorganic fertilisers should  be widened to ensure  a fair balance 
between the technical capacities of the manufacturer  and the need for correct 
information to be provided to  the end -user.  
(26) Furthermore , the tolerance in absolute terms for organic carbon content in soil 
improver should also be widened. Soil  improvers may have a significant content of 
organic carbon, which is not  itself  problematic , as in fact  organic carbon improves the 
quality of soils by enriching their organic matter content. In such cases, allowing for a 
deviation in absolute terms of only one percentage point is very restrictive. It is 
therefore appropriate to allow a bigger deviation in absolute terms while maintaining 
the existing relative devi ation .   
(27) Tolerances should be added for the quantity of a plant biostimulant  and of a fertilising 
product blend, as this i nformation is required to be provided on the label . For a 
fertilising product blend,  a distinction shoul d be made between the blend  mixing two 
EU fertilising products , where the proportion of each of them in the blend can be 
determined and therefore an average of the already set tolerances for each one 
depending on their proportion in the blend can be calculated and applied to the whole 
blend and the functional blend , where one and the same material  passes the conformity 
assessment for two EU fertilising products belonging to two different PFCs and it 
cannot be determined objectively the proportion of each  one in the blend. In the latter 
case, the stricter quantity tolerance of the component PFCs should be applied to the 
whole blend. Indeed, the manufacturer has to prove compliance with the requirements 
of each PFC and th at includes indicating the quantity of each PFC in accordance  with 
its corresponding tolerance. As each PFC represent 100% of the blend in this 
particular case, then the blend as a whole will have to respect the stricter tolerance.      
(28) Based on Regulation  (EU)  2019 /1009 , there are four conformity assessment 
procedures applicable to EU fertilising products, with different level s of complexity 
depending on the ir CMC(s) and the PFC: Module s A, A1, B+C and D1.  
(29) Module D1 has been adapted in order to reflect the specific aspects of EU fertilising 
products derived from waste.  A manufacturer can apply Module s B+C when assessing 
the conformity of an inhibitor  (PFC 5 ) or a plant biostimulant (PFC 6 ), irrespective of 
their component materials. Therefore, as an inadvertent effect of the drafting of 
Annex  IV to Regulation  (EU) 2019/ 1009, nothing may prevent the application of 
Modules B+C, even in the case of the assessment of an inhibitor or a plant 
biostimulant that contain s component materials for which the stricter Module D1 is 
mandatory . It is appropriate to apply a strict confor mity assessment procedure 
whenever  an EU  fertilising product contains component materials  deriving from 
waste, irrespective of its PFC . Therefore, to ensure a high and consistent level of 
protection, Module s B+C should be allowed for  inhibitors and plant b iostimulants only  
when they do not contain such component materials.   
(30) When following the conformity assessment procedures, the m anufacturer  is to provide 
information in the technical documentation concerning , among other  thing s, the total  
EN 11  EN chromium  whenever it is above 200 mg/kg . Regulation (EU) 2019/1009 does not  
indicat e if this limit is to be applied to the dry ma tter or the fresh matter . This 
obligation cannot be fulfilled in a uniform manner in the Union  if it is not clear how  
the 200 mg/kg shou ld be calculated . When setting limit values for contaminants , 
including  hexavalent  chromium (Cr VI), Regulation (EU) 2019/1009 takes into 
account the dry matter. Therefore, for coherence reasons, the content of total 
chromium should be calculate d by refere nce to  dry matter.  
(31) Consultations on the amendments to Regulation (EU) 2019/1009 have been conducted 
in accordance with the principles laid down in the Interinstitutional Agreement of 13 
April 2016 on Better Law -Making17. The Commission expert group on fertilising 
products has been consulted.  
(32) Given that the requirements set out in Annexes I, II , III and IV  to Regulation (EU) 
2019/1009 are to apply with effect from  16 July 2022, it is necessary to defer the 
application of this Regulation to the same date,  
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 Annex II to this Regulation ; 
(3) Anne x 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 J ournal of the European Union . 
It shall apply from 16 July 2022.  
This Regulation shall be binding in its entirety and directly applicable in the Member States in 
accordance with the Treaties.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen  
 
                                                 
17 Interinstitutional Agreement between the European Parliament, the Council of the European Union and 
the European Commission on Better Law -Making ( OJ L 123, 12.5.201 6, p. 1 ).