Placing an EU fertilising product on the market under Regulation (EU) 2019/1009 is often perceived as a matter of nutrient content, contaminant limits and correct labelling. It’s also often perceived (because presented as such) as “easy” and “straightforward” to do. In reality, compliance starts at the level of each individual component used in the formulation and is much more complex than one might think.

The first and most fundamental requirement is that every component must fall within a permitted Component Material Category (CMC) as defined in Annex II of the Regulation.

The logic of the system is clear. The Regulation does not merely regulate finished products; it regulates the very building blocks from which those products are made. If a substance, mixture, or material cannot be clearly allocated to a recognised CMC — and if it does not comply with all technical and legal requirements applicable to that category — it cannot be used in an EU fertilising product.

This applies not only to primary nutrient sources, but equally to secondary ingredients such as stabilisers, coating agents, complexing agents, polymers, or formulation aids.

A single non-compliant component, even added in tiny amounts only (because there is no threshold for taking it into account) is sufficient to disqualify the entire product from CE marking.

At this point, ensuring compliance can already become a rather complex matter, not least because of the regulatory “rat’s tail” that extends into other pieces of EU legislation.

The Fertilising Products Regulation does not operate in isolation.

Its requirements are intertwined with horizontal chemicals legislation, most prominently REACH Regulation (EC) No 1907/2006. What initially appears to be a straightforward CMC assessment may therefore evolve into a broader compliance analysis under REACH and, in certain cases, beyond.

Substances used in fertilising products must be registered where required, and that registration must genuinely support the intended use.

The fact that a substance is commercially available or widely used does not automatically mean it is compliant for fertiliser applications. REACH obligations remain fully applicable, and authorities increasingly expect consistency between the fertiliser regulatory framework and chemicals legislation.

This is where a more subtle, but critical, compliance issue emerges.

Under REACH, uses are described through the use descriptor system, including Product Categories. For fertilising products, the relevant category is PC 12 — Fertilisers. If the REACH registration dossier for a substance does not include PC 12, the downstream use in a fertilising product may not be covered.

In practical terms, this means the registrant has not formally assessed the risks associated with that specific use. Exposure scenarios may not reflect agricultural application, professional spreading, or environmental release patterns associated with fertiliser use.

From a regulatory standpoint, this creates a structural weakness in the compliance strategy.

An additional layer of complexity arises when components have a preservative or antimicrobial function. Consider a liquid fertiliser that incorporates a substance to prevent microbial growth during storage. If the REACH registration does not cover PC 12, but instead aligns more closely with biocidal product categories, regulators may examine whether the substance is performing a biocidal function. This assessment can trigger the application of the Biocidal Products Regulation (EU) No 528/2012.

If the substance is regarded as an active substance for Product Type 6 (PT6 - preservatives for products during storage), the regulatory consequences can be substantial. What was intended as a stabilising formulation aid may place the product within the scope of an entirely different and far more demanding regulatory regime.

For manufacturers, this interconnectedness of legislative frameworks means that compliance cannot be assessed in silos.

Dual regulatory exposure under both the Fertilising Products Regulation and the Biocidal Products Regulation can significantly increase compliance costs, extend timelines, and complicate market access. Moreover, market surveillance authorities are increasingly attentive to these overlaps and inconsistencies.

The regulatory landscape has become more integrated, and inconsistencies between REACH registrations, declared uses, and actual product functions are more likely to attract scrutiny.

In this context, PC 12 coverage should not be treated as an optional administrative detail.

Ultimately, compliance under the European Fertilising Products Regulation is not achieved by focusing solely on the finished product.

It requires a systematic verification of each component’s regulatory status across multiple legislative frameworks.

Every component must fit within a valid CMC.

Every substance must comply with REACH.

And every REACH registration must genuinely encompass the fertiliser use, including PC 12.

Overlooking any one of these elements can destabilise the entire conformity assessment strategy.

Do you need help with this? Reach out to us. Where are there to help.

https://www.scibasics.com/contact

We wish you a brilliant day,

The sciBASICS Team.