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24.6.2022 EN Official Journal of the European Union L 167/29
COMMISSION DELEGATED REGULATION (EU) 2022/973
of 14 March 2022
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,
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 2019laying 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(1), and in particular Article 42(7) thereof,
Whereas:
(1) Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. 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 Council(2),
with some exceptions, which are to be registered in accordance with Regulation (EC) No 1907/2006 of the European
Parliament and of the Council(3).
(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 meaning
of Directive 2008/98/EC in EU fertilising products. To that end, the Commission mandated its Joint Research Centre
(‘JRC’) to provide scientific advice(4).
(3) By-products within the meaning of Directive 2008/98/EC build a very heterogeneous category of substances. These
substances have different physical and chemical nature, and may be obtained during various production processes.
For the purpose of this Regulation, the by-products are divided in two categories, depending on their type of
agronomic efficiency. The first category concerns by-products, which provide nutrients to plants or mushrooms or
improve their nutrition efficiency. The second category concerns by-products which are used as technical additives
in smaller concentrations. Even though they are not directly linked to nutrition or nutrition efficiency, they do
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 production 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 environment, a strict purity requirement should be laid down.
(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 repealing 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), 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).
(4) Huygens D, Saveyn HGM, Technical proposals for by-products and high purity materials as component materials for EU Fertilising Products,
JRC128459, Publications Office of the European Union, Luxembourg, 2022.L 167/30 EN Official Journal of the European Union 24.6.2022
(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, or anti-dusting agents to improve the health protection of users. To ensure that the use of
such by-products does not jeopardise the overall agronomic efficiency of the EU fertilising product and has no
adverse effect on human health or the environment, a maximum concentration in the final EU fertilising product
should be laid down.
(6) In addition, the JRC assessed the most commonly used by-products according to existing practices. 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 based on the straightforwardness of safety criteria
development given the time constraints in performing the assessment. The by-products identified 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 from acetylene production, ferrous slags, metal salts from ore concentrate processing and
metal surface treatment, and humic and fulvic acids from drinking water discolouration. These specific by-products
should be used in EU fertilising products without having to comply with restrictive purity levels for the first
category of by-products or with the purpose and a maximum concentration allowed for the second category of
by-products. The reason is that such by-products are clearly identified, which allowed the JRC to thoroughly assess
their agronomic value and all the specific risks they may raise.
(7) Furthermore, the corresponding supplementary safety criteria for the use of by-products should be laid down.
(8) Some of those by-products should comply with safety criteria limiting 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 category, and without prejudice to Regulation (EU) 2019/1021 of the European
Parliament and of the Council(5).
(9) Additional limit values 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 containing
by-products with such contaminants does not lead to their accumulation in soil. The limit values for such
contaminants should be determined as concentration in the final product, similar to the requirements set out in
Annex I to Regulation (EU) 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 conformity assessment and market surveillance of such products, as tests are to be carried out only on the final
product.
(10) Residues from the processing or purification of sedimentary phosphate ore are known to contain naturally
occurring radionuclides. In order to ensure safe use of such by-products in EU fertilising products, it is appropriate
to lay down maximum permitted levels of activity concentration values of naturally occurring radionuclides, from
the uranium and thorium series in EU fertilising products containing such materials.
(5) 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).24.6.2022 EN Official Journal of the European Union L 167/31
(11) Furthermore, additional safety criteria should be laid down to limit the content of 16 polycyclic aromatic
hydrocarbons (PAH )(6)and of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF)(7). Regulation
16
(EU) 2019/1021 lays down release reductions for PAH and PCDD/PCDF as unintentionally produced substances
16
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 component material
level and not as concentration in the final product, to ensure coherence with Regulation (EU) 2019/1021.
(12) The limit values for contaminants, PAH and PCDD/PCDF may not be relevant in all cases. Therefore, manufacturers
16
should have the possibility to presume the conformity 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.
(13) Some of the by-products may contain selenium, which can be toxic if present in high concentration. Some may also
contain chloride, which may raise concerns regarding the salinity in soil. Whenever those substances are present in
concentrations exceeding a certain limit, their content should be indicated on the label so that the users of the
fertilising product are properly informed.
(14) Given that 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
1. By-products belonging to Component Material Category (CMC) 11 referred to in Part II of Annex II to Regulation
(EU) 2019/1009, which provide nutrients to plants or mushrooms or improve their nutrition efficiency, shall meet the
following criteria for agronomic efficiency and safety:
(a) contain at least 95 % by dry matter of ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium
carbonate or calcium oxide, or mixtures thereof;
(b) are 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 Council(8);
(c) have an organic carbon (C ) content of no more than 0,5 % of the dry matter of the by-product;
org
(d) contain no more than 6 mg/kg dry matter of polycyclic aromatic hydrocarbons (PAH )(9);
16
(6) 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.
(7) 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.
(8) 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).
(9) 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.L 167/32 EN Official Journal of the European Union 24.6.2022
(e) contain no more than 20 ng WHO toxicity equivalents(10)/kg dry matter of the polychlorinated dibenzo-para-dioxins
and dibenzofurans (PCDD/PCDF)(11).
An EU fertilising product containing or consisting of by-products providing nutrients to plants or mushrooms or
improving their nutrition efficiency shall contain no more than:
(a) 400 mg/kg dry matter of total chromium (Cr);
(b) 2 mg/kg dry matter of thallium (Tl).
2. By-products belonging to CMC 11 referred to in Part II of Annex II to Regulation (EU) 2019/1009, which are used as
technical additives, shall meet the following criteria for agronomic efficiency and safety:
(a) have the role to improve the safety or agronomic efficiency of the EU fertilising product;
(b) are present in the EU fertilising product at a total concentration of no more than 5 % by mass;
(c) contain no more than 6 mg/kg dry matter of polycyclic aromatic hydrocarbons (PAH );
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(d) contain no more than 20 ng WHO toxicity equivalents(12)/kg dry matter of the polychlorinated dibenzo-para-dioxins
and dibenzofurans (PCDD/PCDF).
Article 2
1. The criteria laid down in Article 1 do not apply to by-products belonging to CMC 11 referred to in Part II of Annex II
to Regulation (EU) 2019/1009, which are either of the following:
(a) mother liquor from the reaction of 5(β-methyl-thioethyl)-hydantoin with potassium carbonate in the methionine
production process;
(b) residues from the processing and purification of minerals and ores, if they contain calcium carbonates, magnesium
carbonates, calcium sulphates, magnesium oxide, phosphate salts, and/or water-soluble salts of potassium, magnesium
or sodium, in a total content of more than 60 % dry matter of the residues;
(c) post-distillation liquid from Solvay process;
(d) carbide lime from acetylene production;
(e) ferrous slags;
(f) 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 (Mn) or cobalt (Co)) in solution;
(g) humic and fulvic acids from drinking water discolouration.
2. The activity concentration values of naturally occurring radionuclides from the U-238 and Th-232 series in an EU
fertilising product containing or consisting of residues from the processing or purification of sedimentary phosphate ore
in accordance with paragraph 1, point (b) shall not exceed 1 kBq/kg of the product.
(10) 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. doi:10.1093/toxsci/kfl055.
(11) 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.
(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. doi:10.1093/toxsci/kfl055.24.6.2022 EN Official Journal of the European Union L 167/33
3. An EU fertilising product containing or consisting of by-products referred to in points (e) and (f) of the first paragraph
shall contain no more than:
(a) 400 mg/kg dry matter of total chromium (Cr);
(b) 2 mg/kg dry matter of thallium (Tl);
(c) 600 mg/kg dry matter of vanadium (V).
Article 3
Where compliance with a given requirement laid down in Article 1(1), first subparagraph, points (d) and (e), Article 1(1),
second subparagraph, Article 1(2), points (c) and (d), and Article 2(2) and (3), follows certainly and uncontestably from the
nature or manufacturing process of the by-product or of the EU fertilising product containing such a by-product, as
applicable, that compliance may be presumed in the conformity assessment procedure without verification (such as
testing), at the responsibility of the manufacturer.
Article 4
1. Where an EU fertilising product contains or consists of by-products referred to in Article 1(1), first subparagraph and
in Article 2, first paragraph, points (b) to (f), and has a selenium (Se) content exceeding 10 mg/kg dry matter, the selenium
content shall be indicated.
2. Where an EU fertilising product contains or consists of by-products referred to in Article 1(1), first subparagraph and
in Article 2, first paragraph, points (b), (c) and (g), and has a chloride (Cl-) content exceeding 30 g/kg dry matter, the
chloride content shall be indicated, unless the EU fertilising product is produced through a manufacturing process where
chloride containing substances or mixtures have been used with the intention of producing or including alkali metal salts
or alkaline earth metal salts, and information on these salts is provided in accordance with Annex III.
3. When the content of selenium or chloride is indicated in accordance with paragraphs 1 and 2, it shall be clearly
separated from nutrient declaration and it may be expressed as a range of values.
4. Where the fact that such an EU fertilising product contains selenium or chloride below the limit values in paragraphs
1 and 2 follows certainly and uncontestably from the nature or manufacturing process of the by-product or of the EU
fertilising product containing such a by-product, as applicable, the label may contain no information on these parameters,
without verification (such as testing), at the responsibility of the manufacturer.
Article 5
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 directly applicable in all Member States.
Done at Brussels, 14 March 2022.
For the Commission
The President
Ursula VON DER LEYEN