Fertilisers and biostimulants can be marketed in the European Union through two main regulatory routes:

• CE marking, in accordance with Regulation (EU) 2019/1009.
• National registration, based on the legislation of a Member State, with the possibility of subsequently expanding the product’s commercialisation through mutual recognition.

For this reason, the choice between these two options should be made before starting trials, preparing labels or submitting dossiers. The product composition, its functions, the raw materials used and the target countries may make one option considerably more suitable than the other.

Regulation (EU) 2019/1009 establishes common requirements for placing EU fertilising products on the European market.

CE marking is not a registration granted by a central authority. It is the result of a conformity assessment procedure through which the manufacturer demonstrates that the product complies with all applicable requirements.

To follow this route, two main aspects must be assessed.

1. Product Function Category

First, the product must fall within a Product Function Category, or PFC, such as a fertiliser, liming material, soil improver, growing medium, inhibitor, plant biostimulant or fertilising product blend.

The selected category determines the functions that may be claimed, the applicable quality and safety requirements and, where relevant, the efficacy trials required.

2. Component Material Categories

All components must comply with one of the Component Material Categories, or CMCs, established in the Regulation.

The CMCs cover, among others, virgin material substances and mixtures, plant extracts, compost, digestates, food-industry by-products, microorganisms, polymers, animal by-products and certain recovered materials.

This assessment is essential. A raw material may have agronomic value and be safe, but it may still be unsuitable for CE marking if it does not fall within a CMC or does not comply with the applicable requirements concerning its origin, manufacturing process, purity or contaminants.

Conformity assessment

Once the product function and raw materials have been classified, the applicable conformity assessment module must be determined.

Depending on the product, Module A, A1, B+C or D1 may apply. Some procedures can be managed through the manufacturer’s internal production control, while others require the involvement of a notified body.

The technical documentation must include, among other things:

• The product composition.
• The origin and compliance of the raw materials.
• The manufacturing process.
• Quality and safety analyses.
• Efficacy trials, where applicable.
• Compliance with labelling requirements.

Once the procedure has been successfully completed, the manufacturer issues the EU Declaration of Conformity and affixes the CE marking.

When is the CE route appropriate?

CE marking is usually the most appropriate option when:

• The product clearly falls within a PFC.
• All components comply with a CMC.
• The necessary documentation and trials are available.
• The company intends to market the product in several European countries.
• There is a medium- or long-term expansion strategy.

Its main advantage is that it allows the EU fertilising product to be marketed throughout the European market without having to obtain a separate national authorisation in each country.

However, not all products can meet the requirements or fall within the current CMCs established under Regulation (EU) 2019/1009.

NATIONAL REGISTRATION

Member States maintain their own legislation for fertilising products that are not marketed with CE marking.

Requirements may vary considerably between countries. Differences may exist in relation to:

• Product categories.
• Permitted raw materials.
• Minimum nutrient contents.
• Contaminant limits.
• Efficacy trials.
• Documentation and labelling.
• Fees and assessment times.

Furthermore, not all countries use the same procedure. Depending on the Member State, market access may require registration, authorisation, notification or direct compliance with a national product category.

For this reason, it is more accurate to refer to the national route rather than assuming that a formal registration procedure always exists.

When may national registration be preferable?

This strategy may be appropriate when:

• A raw material is not permitted under the CMCs.
• The product does not comply with the requirements of a PFC.
• It contains a microorganism that is not currently accepted under European legislation.
• National legislation provides for a more suitable product category.
• The company initially intends to market the product in only one or a small number of countries.
• An initial market entry is sought before developing a broader European strategy.

The choice of the first country is particularly important. It should not be based solely on fees or estimated processing times, but also on the possibility of subsequently expanding the product’s commercialisation to other Member States.

Mutual recognition

Mutual recognition does not constitute a completely separate third route. It is a tool that may be used within the national registration strategy.

The procedure does not entail automatic acceptance. The authority in the destination country may assess the product, request clarification and raise justified objections.

For this reason, the quality of the first national dossier and the selection of the Member State of origin are decisive.

How should the correct strategy be selected?

There is no single route that is universally better, this will depend on each company’s commercial objectives.

CE marking provides a harmonised and scalable solution, but it requires the product to comply fully with the relevant PFCs, CMCs and conformity assessment procedure.

The national route may offer greater flexibility for formulations that do not fall within Regulation (EU) 2019/1009. Mutual recognition may enable their expansion into other countries, provided that the product is lawfully marketed and the dossier has been properly prepared.

If the national route is chosen, the company must have a legal entity established in the European Union and, for certain national registrations, a subsidiary in the country concerned. By contrast, under the European route, the exporter does not need to be established in the EU, as a company based outside the EU may still act as the registration holder.

How Sun Chemicals Services can help

At Sun Chemicals Services, we assess each product to define the most appropriate regulatory strategy.

Our team prepares and manages CE-marking dossiers, national procedures and mutual recognition applications. We also support companies throughout the assessment process, coordinate with notified bodies and respond to requests from the competent authorities.

Please contact our team to learn more about our services.

July 2026

Sun Chemicals Services Team

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