(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.

(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.

(11)

Furthermore, additional safety criteria should be laid down to limit the content of 16 polycyclic aromatic hydrocarbons (PAH16) (6) and of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) (7). Regulation (EU) 2019/1021 lays down release reductions for PAH16 and PCDD/PCDF 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 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, PAH16 and PCDD/PCDF may not be relevant in all cases. Therefore, manufacturers 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,