Rules governing the production and marketing of fertilisers

Anyone who manufactures, distributes or uses fertilisers within the European Union is required to comply with the applicable legislation.

The current legal framework is based on a dual system: on one side, the national legislation centred on Legislative Decree No. 75 of 29 April 2010, which governs fertilisers placed on the Italian market; on the other, Regulation (EU) 2019/1009, which regulates EU fertilising products intended for free circulation within the internal market through CE marking.

The coexistence of these two regulatory frameworks requires operators to properly identify the product classification, its composition, intended use, and the applicable authorisation or conformity pathway.

Fertilisers and soil fertility: a technical overview

In technical and legal terminology, the term fertiliser includes products intended to:

  • supply nutrients to plants;
  • improve the physical, chemical or biological characteristics of the soil;
  • correct abnormal soil conditions;
  • enhance nutrient use efficiency or support crop cultivation.

Regulatory classification depends not only on chemical composition, but also on the claimed function, raw materials used, analytical requirements met and the information provided on the label.

Legislative Decree No. 75/2010: the Italian regulatory framework for fertilisers

Legislative Decree No. 75 of 29 April 2010 (“Reorganisation and revision of fertiliser legislation”) represents the primary Italian regulatory reference for fertilisers.

The decree follows a positive-list approach: a product may be marketed nationally as a fertiliser only if it falls within one of the categories established in the technical annexes, complying with the relevant type designation, minimum requirements, declarable nutrient contents, tolerance limits, safety parameters and labelling provisions. The annexes therefore have a technical and prescriptive value and constitute the operational core of the legislation.

Article 2 provides the general definition of “fertilisers” and includes products and materials intended to fulfil different functions:

  • Fertilisers: products whose primary function is to provide nutrients to plants. Under Legislative Decree No. 75/2010, fertilisers have traditionally been classified as EC fertilisers and national fertilisers; the latter are identified according to type and characteristics in Annex 1. This category includes products supplying primary nutrients, secondary nutrients or micronutrients in declarable forms and quantities, including organic fertilisers and organo-mineral fertilisers where they comply with the requirements of the relevant product types.
  • Soil improvers: products primarily intended to maintain or improve the physical, chemical, biological and mechanical properties of soil. Their main function is to enhance overall soil fertility, for example by increasing organic matter content, improving soil structure, enhancing water retention capacity or stimulating biological activity. For this reason, soil improvers are often considered strategic tools in soil fertility management programmes.
  • Correctives: products intended to modify and improve abnormal soil chemical properties, particularly pH, salinity or other parameters that may limit nutrient availability and crop development.
  • Growing media: materials other than in situ soil, used as a growing medium for plants. They may be employed in nurseries, floriculture, container-grown crops or soilless cultivation systems and must possess physical, chemical and biological characteristics suitable for root development.
  • Organic matrices: materials of organic origin used in the manufacture of fertilisers or as components of specific product categories. Their regulatory relevance depends on composition, origin, hygiene and sanitary requirements, and traceability, especially when derived from residual streams or treatment processes.
  • Products with specific action: products which, although not necessarily intended to provide nutrients directly, are designed to exert specific effects on plants, soil or fertilisers. According to the annexes of the decree and subsequent amendments, this category includes products such as biostimulants, inoculated fertilisers, inhibitors, co-formulants and other preparations with a specific technical function.

Fertiliser formulations

Fertilisers are manufactured in solid, liquid or gaseous form.

Solid fertilisers are the most widely used and are suitable for soil application, both as basal and top-dressing fertilisation. They may be:

  • granular and prilled: granules vary in size and may be coated with specific materials that promote controlled or slow nutrient release over time;
  • powdered: ideal for localised applications or for dissolving in water before use. However, they tend to generate dust during spreading;
  • pelleted or microgranular: pellets are mainly used for organic and organo-mineral fertilisers and improve product stability. Microgranules are placed close to the seed during sowing to stimulate early crop development.

Fluid fertilisers (liquids and gases) are applied through dilution in irrigation water (fertigation) or sprayed directly onto leaves (foliar fertilisation). They may be:

  • soluble liquids/suspensions: ready-to-use formulations in which nutrients are dissolved in water or maintained in a homogeneous suspension. They provide rapid nutrient uptake by plants;
  • liquefied gases: certain specific fertilisers, such as anhydrous ammonia, are stored and distributed in liquid form under pressure and return to a gaseous state when injected into the soil.

CE marking of fertilisers and Regulation (EU) 2019/1009

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 establishes harmonised rules for making EU fertilising products available on the market. It repealed Regulation (EC) No. 2003/2003 and has applied since 16 July 2022. The regulation covers mineral fertilisers, organic products, organo-mineral products, soil improvers, growing media, inhibitors and plant biostimulants.

The Regulation introduces a system based on CE marking: products meeting the applicable requirements may circulate freely within the Union market, and Member States cannot restrict their marketing on aspects already harmonised by the legislation. Adoption of the European framework remains optional: where CE marking is not used, a product may continue to be marketed under national rules, provided it is not presented as an EU fertilising product bearing CE marking.

The European classification system is based on Product Function Categories (PFCs), which identify the product’s function. The main categories include fertilisers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and blends of fertilising products. Correct PFC classification is essential because it determines the applicable requirements for safety, quality, labelling and conformity assessment. In particular, an organic fertiliser or organo-mineral fertiliser must be evaluated not only for its nutritional function but also with regard to constituent materials and contaminant limits established by the Regulation.

In addition to functional classification, the Regulation requires products to consist exclusively of materials compliant with one or more Component Material Categories (CMCs). CMCs include, among others, substances and virgin material mixtures, plants or plant extracts, compost, digestates, food industry by-products, microorganisms, polymers, derived products from animal by-products, pyrolysis and gasification materials, thermal oxidation materials and precipitated phosphates. This approach makes it possible to integrate recovered and organic raw materials within a European framework of safety and traceability.

One of the most significant innovations introduced by Regulation (EU) 2019/1009 is the recognition of plant biostimulants as a specific functional category. These products do not primarily act by supplying nutrients but by stimulating natural processes aimed at improving:

  • nutrient use efficiency;
  • tolerance to abiotic stress;
  • crop quality;
  • nutrient availability in the soil or rhizosphere.

Relationship between Italian and European fertiliser legislation

Legislative Decree No. 75/2010 and Regulation (EU) 2019/1009 do not exclude one another but operate on different levels. Operators must choose the most appropriate regulatory pathway according to the target market, product composition, availability of suitable PFCs and CMCs, and compliance costs.

The specific case of fertilisers permitted in organic farming

The main legislative reference for organic production is Regulation (EU) 2018/848, which establishes the general principles of organic farming and prohibits the use of synthetic chemical fertilisers. Specific provisions regarding fertilisers and soil improvers are set out in Implementing Regulation (EU) 2021/1165, which precisely lists (in Annex II) the products permitted and the conditions for their use.

Annex 13 of Legislative Decree No. 75/2010 contains the list of fertilisers suitable for use in organic farming, indicating the permitted raw materials of natural origin.

A matter of strategy

Current fertiliser legislation requires an integrated approach combining national regulations, European regulations and technical product communication. Legislative Decree No. 75/2010 continues to represent the benchmark for many products intended for the Italian market, while Regulation (EU) 2019/1009 provides a harmonised route for marketing throughout the European Union through CE marking. The choice between the two regulatory frameworks is not merely a formal matter: it affects classification, technical documentation, labelling, controls, responsibilities and commercial strategy.


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