EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2019/1009 of the European Parliament and of the 
Council by laying down criteria on agronomic efficiency and safety for the use of by -
products in EU fertilising products  
(Text with EEA relevance)   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
According to Article 42(7 ) of Regulation  (EU) 2019/1009  (1), by 16 July 2022, the 
Commission has to supplement Annex II, Part II, C omponent Material Category (CMC)  11, 
point 3 by laying down criteria for agronomic efficiency and safety for the use of by products 
within the meaning of Directive 2008/98/EC (2) in EU fertilising products. Such criter ia have 
to reflect  present product manufacturing practices, technological developments and the latest 
scientific evidence.  
The Commission mandated its Joint Research Centre to provide scientific advice in fulfilling 
this task.  
This delegated Regulation is  based on the R eport of the Commission’s Joint Research Centre  
(‘JRC’) on Technical proposals for by -products and high purity materials as component 
materials for EU Fertilising Products . (link to the report when published to be added in a 
footnote)  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Pursuant to Article 44(4) of Regulation (EU) 2019/1009, experts designated by each Member 
State  were consulted in the Commission expert group on Fertilising Products (E01320) 
according to the rules of the Inte rinstitutional Agreement on Better Law -Making of 13 April 
20163. 
Details of these consultations can be found in the minutes of the meeti ng held on [] November 
2021 , 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 -4ace02907f 2f/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 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 details once the consultation is done ]  
3. LEGAL  ELEMENTS  OF THE  DELEGA TED  ACT  
The legal act supplements  Regulation (EU) 2019/1009. The legal basis of this delegated act is 
Article 42( 7) 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 –114. 
2 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 –30. 
3 OJ L 123, 12.5.2016, p. 1 –14. EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
supplementing Regulation (EU) 2019/1009 of the European Parliament and of the 
Council by laying down criteria on agronomic efficiency and safety for the use of by -
products in EU fertilising products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Havin g 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(7) thereof,  
Whereas:  
(1) Regulation (EU) 2019/1009  lays down rules on the making available on the ma rket of 
EU fertilising pr oducts. EU fertilising products contain component materials of one or 
more of the categories listed in Annex II to that Regulation. In accordance with 
component material category ( ‘CMC ’) 11 of that Annex , EU fertilising products may 
contain by -products within the meaning of Directive 2008/98/EC of the European 
Parliament and of the Council2, with some exceptions, and which are to be registered 
in accordance with Regulation (E C) No 1907/2006 of the Europea n Parliament and of 
the Council3. 
(2) Article 42(7) of Regulation (EU) 2019/1009 requires the Commission to supplement 
Part II, CMC 11, point 3 , of Annex II , by laying down criteria for agronomic 
efficiency and safety for the use of by -products within the mean ing of Directive 
2008/98/EC in EU fertilising products. To that end, t he Commission mandated its 
Joint Research Centre (‘JRC’) to provide scientific advice  (link to the report when 
published  to be added in a footnote) .   
(3) By-products within the meaning of D irective 2008/98/EC build  a very heterogeneous 
category of  substances. These substances can have  different physical and chemical 
nature , which  may be obtained during  various production processes. For the purpose 
of this Regulation, the by -products are divided in two categories, depending on their 
                                                 
1 OJ L 170, 25.6.2019, p. 1.  
2 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste 
and repe aling certain Directives (OJ L 312, 22.11.2008, p. 3 ). 
3 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), 
establishin g 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).  EN 3  EN type of agronomic efficiency. Firstly, there are by -products , which provide nutrients to 
plants. Secondly, there are by -products which are used as technical additives  in 
smaller concentrations , and, even though  they do not provide nutrients to plants, they 
are agronomically efficient as they improve the quality of the fertilising product or the 
safety in handling it.  
(4) For the first category,  the JRC has identified by-products resulting from a variety of 
productio n processes , which contain ammonium  salts, sulphate salts,  phosphate salts,  
elemental sulphur, calcium carbonate and calcium oxide . To ensure that those by -
products have a clear agronomic value and do not create adverse effects for human 
health and the env ironment, a strict purity requirement should be lay down.  
(5) For the second category,  the JRC proposed to allow the use of  by-products as  technical 
additives , such as hardening, binding or filling agents. To ensure that the use of such 
by-products  has no adve rse effect on human health or the environment, a maximum 
concentration in the final EU fertilising product should be laid down.  
(6) In addition, t he JRC assessed the most commonly used by-products  according to  
existing practices  to determine if derogatory req uirements from the restrictive purity 
level or the low quantities allowed in EU fertilising products should be laid down for 
certain clearly determined categories of by -products . Those by-products have been 
selected based on their  market potential, available  data, on their current legal situation , 
on their  use history,  and on their clear agronomic value, as well as the  
straightforwardness of safety criteria development  given the time constrain ts in 
performing the assessment. The by-products identifie d were mother liquor from the 
reaction of 5(β -methyl -thioethyl) -hydantoin with potassium carbonate in the 
methionine production process , residues from mineral and ore processing and 
purification , post-distillation liquid from Solvay process , carbide lime f rom acetylene 
production , ferrous slags , metal salts from ore concentrate processing and metal 
surface treatment , and humic and fulvic acids from drinking water discolouration .  
(7) Therefore, the corresponding supplementary agronomic efficiency and safety cri teria 
for the use of by-products  should be laid down. These criteria are to apply in addition 
to the safety  and agronomic efficiency  criteria laid down in Annex I to Regulation 
(EU) 2019/1009 . 
(8) Furthermore , some of these  by-products   should , depending on their production 
processes,  comply with safety criteria  limit ing the content of contaminants  and other 
substances of concern , applied in addition to those that are laid down in Annex I to 
Regulation (EU) 2019/1009  for the corresponding product function cat egory , and 
without prejudice to Regulation (EU) 2019/1021 of the European Parliament and of 
the Council4.  
(9) Therefore,  additional limit  value s should be laid down for the contaminants total 
chromium, thallium and vanadium. Some of the by -products may contain such 
contaminants as a result of the particularity of their production process. The proposed 
limit  values  for those contaminants  should ensure that the use of EU fertilising 
products contain ing by -products with such contaminants  does not lea d to their 
accumulation in soil . The limit  values  should be determined as concentration in the 
final product, similar to the requirements set o ut in Annex I to Regulation (EU) 
                                                 
4 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 4  EN 2019/1009 . This is justified by the fact that the safety criteria introduced in reply to 
any particular risks identified concern, as a rule, the final product and not a component 
material. This should  facilitate the conform ity assessment and market surveillance of 
such products , as tests are to be carried  out only on the final product.  
(10) Furthermore, additional safety criteria should be laid down  to limit the content of 16 
polycyclic aromatic hydrocarbons (PAH 16)5 and,  polychlorinated dibenzo -p-dioxins 
and dibenzofurans (PCDD/PCDF)6. Regulation (EU) 2019/102 1 lays down  release 
reductions for PAH 16 and PCDD/ PCD F as unintentionally produced substances  during 
manufacturing processes, but does not introduce a limit  value  in such cases . Given the 
high risks generated by the presence of such pollutants  in fertilising products , it is 
considered appropriate to introduce more stringent requirements than those laid down 
in that Regulation . Such limit  values  should be laid down at co mponent material level 
and not as concentration in the final product , to ensure coherence  with Regulation 
(EU) 2019/ 1021.  
(11) The limit values referred to in recitals (8) -(10) may not be relevant in all cases . 
Therefore, manufacturers should have the possibility to presume  the c onformity of the 
fertilising product  with a given  requirement without verification , such as testing,  
whenever the compliance  with the said  requirement follows certainly and 
uncontestably from the nature or manufacturing process of the by -products belonging 
to CMC 11  or of the EU fertilising product containing such a by -product . 
(12) Some of the by -products may contain micronutrient selenium , which can be toxic if 
present in high concentration . Some may also contain chloride, which raises concerns 
regarding the salinity in soil . Whenever those substances are present in concentrations 
exceeding  a certain limit, their content should be declare d on the label so that the 
users of the fertilising product are properly informed.  
(13) Given tha t Regulation (EU) 2019/1009 will fully apply from  16 July 2022, it is 
necessary to defer the application of this Regulation to the same date ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
By-products belonging to Component Material Category (CMC) 11 referred to in Part II of 
Annex II to Regulation (EU) 2019/1009 ,  shall  meet  one the following two sets of criteria  for 
agronomic efficiency and safety : 
1. By-products providing nutrient s to plants  shall :  
(a) contain  at least 95  % dry matter  of the by-product  of ammoni um salts, sulphate 
salts, phosphate salts, elemental sulphur, calcium carbonate or calcium oxide , 
or mixtures thereof ; 
                                                 
5 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.  
6 Sum of 2,3,7,8 -TCDD, 1,2,3,7,8 -PeCDD; 1,2,3,4 ,7,8-HxCDD; 1,2,3,6,7,8 -HxCDD; 1,2,3,7,8,9 -
HxCDD; 1,2,3,4,6,7,8 -HpCDD; OCDD; 2,3,7,8 -TCDF; 1,2,3,7,8 -PeCDF; 2,3,4,7,8 -PeCDF; 1,2,3,4,7,8 -HxCDF; 
1,2,3,6,7,8 -HxCDF; 1,2,3,7,8,9 -HxCDF; 2,3,4,6,7,8 -HxCDF; 1,2,3,4,6,7,8 -HpCDF; 1,2,3,4,7,8,9 -HpCDF; and 
OCDF.  EN 5  EN (b) be produced as an integral part of a production process that uses as input 
materials substances and mixtures, other than animal by -products  or derived 
products within the scope of Regulation (EC) No 1069/2009  of the European 
Parliament and of the Council7;  
(c) have an organic carbon ( Corg) content of no more than 0 ,5 % of  the dry matter 
of the by-product ;  
(d) contain no more than  6 mg/ kg dry matter  of polycyclic aromatic  hydrocarbons 
(PAH 16)8; and  
(e) contain no more than  20 ng WHO toxicity equivalents9/kg dry  matter of the 
polychlorinated dibenzo -para-dioxins and dibenzofurans (PCDD/PCDF)  10. 
An EU fertilising product containing or consisting of by-products providing nutrients to plants  
shall  contain  no more than : 
(a) 400 mg/kg dry matter of total chromium (Cr); and 
(b) 2 mg/kg dry matter of thallium  (Tl). 
2. By-products used as technical additives shall :  
(a) improve the  safety or agronomic efficiency  of the EU fertilising product ;  
(b) be present in the EU fertilising product at a total concentration of no more than 
5 % by mass ; 
(c) contain no more tha n 6 mg/ kg dry matter of polycyclic aromatic  hydrocarbons 
(PAH 16)11; and  
(d) contain no more tha n 20 ng WHO toxicit y equivalents12/kg dry  matter of the 
polychlorinated dibenzo -para-dioxins and dibenzofurans (PCDD/PCDF)13. 
                                                 
7 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).  
8 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.  
9 van den Berg M., L.S. Birnbaum, M. Denison, M. De Vito, W. Farland, et al. (2006) The 2005 World 
Health Organization Re -evaluation of Human and Mammalian Toxic Equivalency Factors for D ioxins 
and Dioxin -like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 
93:223 -241. doi:10.1093/toxsci/kfl055.  
10 Sum of 2,3,7,8 -TCDD, 1,2,3,7,8 -PeCDD; 1,2,3,4,7,8 -HxCDD; 1,2,3,6,7,8 -HxCDD; 1,2,3,7,8,9 -
HxCDD; 1,2,3,4,6,7,8 -HpCDD; OCDD; 2,3,7,8 -TCDF; 1,2,3,7,8 -PeCDF; 2,3,4,7,8 -PeCDF; 1,2,3,4,7,8 -HxCDF; 
1,2,3,6,7,8 -HxCDF; 1,2,3,7,8,9 -HxCDF; 2,3,4,6,7,8 -HxCDF; 1,2,3,4,6,7,8 -HpCDF; 1,2,3,4,7,8,9 -HpCDF; and 
OCDF.  
11 Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phen anthrene, anthracene, fluoranthene, 
pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, 
indeno[1,2,3 -cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.  
12 van den Berg M., L.S. Birnbaum, M. Denison, M. De  Vito, W. Farland, et al. (2006) The 2005 World 
Health Organization Re -evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins 
and Dioxin -like Compounds. Toxicological sciences: an official journal of the Society of Toxicology 
93:223 -241. d oi:10.1093/toxsci/kfl055.  
13 Sum of 2,3,7,8 -TCDD, 1,2,3,7,8 -PeCDD; 1,2,3,4,7,8 -HxCDD; 1,2,3,6,7,8 -HxCDD; 1,2,3,7,8,9 -
HxCDD; 1,2,3,4,6,7,8 -HpCDD; OCDD; 2,3,7,8 -TCDF; 1,2,3,7,8 -PeCDF; 2,3,4,7,8 -PeCDF; 1,2,3,4,7,8 -HxCDF; 
 EN 6  EN Article 2 
The criteria in Article  1 do not apply to the by-products belonging to CMC 11 referred to in 
Part II of Annex  II to Regulation (EU) 2019/1009  which comply with one  of the following 
alternative criteria :  
(a) are mother liquor from the reaction of 5( β-methyl -thioethyl) -hydantoin with 
potassium carbonate in the methionine production process ; 
(b) are residues from the processing and purification of minera ls and ores, if they contain 
calcium carbonates, magnesium carbo nates, calcium sulphates,  magnesium oxide, 
phosphate salts, and/or water -soluble salts of potass ium, magnesium or sodium, in a 
total content of more than 60  % dry matter  of the residues;  
(c) are post-distilla tion liquid from Solvay process;  
(d) are carbide lime from acetylene production ; 
(e) are ferrous slags ; 
An EU fertilising product containing or consisting of ferrous slags  shall  contain  no more than : 
(a) 400 mg/kg dry matter of total chromium (Cr);  
(b) 2 mg/k g dry matter of thallium  (Tl); and  
(c) 600 mg/kg dry matter of vanadium  (V). 
(f) are substances derived from ore concentrate processing and metal surface treatment 
that contain at least 2  % by mass of di - or tri -valent transition metal cations (zinc 
(Zn), copper (Cu), iron (Fe), manganese (M n) or cobalt (Co)) in solution, if the free 
acid content (as summed hydrochloric acid, hydrofluoric acid, nitric acid and 
sulphuric acid) is lower than 2,5  % by mass;  
An EU fertilising product containing or consisting of such s ubstances  shall  contain  no more 
than: 
(a) 400 mg/kg dry matter of total chromium (Cr);  
(b) 2 mg/kg dry matter of thallium  (Tl); and  
(c) 600 mg/kg dry matter of vanadium  (V). 
(g) are humic and fulvic acids from drinking water discolouration .  
Article 3 
Where compliance with a given requirement laid down in Article 1, paragraph  1, first sub -
paragraph, points (d) and (e), and second and third sub -paragraphs, Article 1, paragraph 
2,,points (c) and (d) and Article 2, points (e)(i) -(iii) and  (f)(i) -(iii), follows certainly and 
uncontestably from the nature or manufacturing process of the by-products or of the EU 
fertilising product, as applicable , that compliance may be presumed in the conformity 
assessment procedure without verification, at the responsibility  of the manufacturer.  
                                                                                                                                                         
1,2,3,6,7,8 -HxCDF; 1,2,3,7,8,9 -HxCDF; 2 ,3,4,6,7,8 -HxCDF; 1,2,3,4,6,7,8 -HpCDF; 1,2,3,4,7,8,9 -HpCDF; and 
OCDF.  EN 7  EN Article 4 
1. Where an EU fertilising product contains or consists of by -products referred to in 
Article 1(1 ), and in Article 2, points  (b) to (f), and has a selenium (Se) content 
exceeding  10 mg/kg dry matter, the selenium content shall be declared.  
2. Where an EU fertilising product contains or consists of by -products referred to in 
Article 1 (1), and in Article 2, points  (b), (c)  and (g) , and has a chloride ( Cl-) content 
exceeding  30 g/kg dry matter, the chloride content shall be declared .  
Article  45 
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  16 July 2022.  
This Regulation shall be binding in its entirety and di rectly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen