CONTEXT AND PURPOSE OF THE REGULATION:

• Main objective: To unify and update the rules applicable to fertilizing products placed on the EU market, including fertilizers, soil amendments, plant biostimulants, and other related products.
• Need for harmonization: Prior to this regulation, EU fertilizer legislation was only partially harmonized (Regulation (EC) No 2003/2003), while national regulations continued to coexist. This made intra-EU trade more difficult and created legal uncertainty.
• Scope: Covers fertilizing products bearing the CE marking that meet the requirements laid down in the Regulation, whether manufactured in the EU or imported from third countries

CATEGORIES OF PRODUCTS AND BASIC REQUIREMENTS:

1. Product Function Categories (PFC): The Regulation creates seven main groups of products according to their function:

PFC 1: Fertiliser – Includes inorganic, organic, and organo-mineral fertilizers.

PFC 2: Liming material – Products intended to improve the soil’s physical, chemical, or biological properties.

PFC 3: Soil improver – Provides beneficial effects to maintain or enhance soil biological activity and soil properties.

PFC 4: Growing medium – Includes products that regulate the rate at which nutrients are released to the plant.

PFC 5: Inhibitor – Substances that slow down processes like nitrification or the hydrolysis of urea.

PFC 6: Plant biostimulant – Formulated to stimulate the plant’s natural processes and improve nutrient uptake, stress tolerance, crop quality, etc

PFC 7: Fertilising product blend – Combinations of two or more products from the above categories.

2. Component Material Categories (CMCs)

In addition to the product’s function (PFC), the Regulation defines 15 Component Material Categories (CMC), describing which types of materials (e.g., virgin raw materials, by-products, recycled waste) can be used to manufacture a CE-marked fertilizer.

Each CMC has specific quality and purity criteria (e.g., limits on contaminants, heavy metals, pathogenic microorganisms), and they include both organic materials (e.g., agricultural waste, by-products) and inorganic materials (minerals, chemical compounds).

3. Safety and Environmental Requirements

• Maximum limits for contaminants and heavy metals (such as cadmium, lead, mercury, etc.) and other potentially toxic or hazardous substances.
• Sets threshold values for pathogens that could affect human health or the environment.
• Places the responsibility on operators to demonstrate product compliance through evaluations and laboratory testing.

OBLIGATIONS OF ECONOMIC OPERATORS:

1. Manufacturers

• Ensure that products meet essential requirements and safety standards.
• Keep technical documentation and carry out conformity assessment procedures.
• Mark products with the CE marking and provide relevant information on the label.

2. Importers

• Verify that fertilizing products from third countries meet the same requirements as products manufactured in the EU.
• Keep documentation and cooperate with market surveillance authorities.

3. Distributors

• Ensure that products remain compliant during storage and marketing.
• Inform the authorities if products are non-compliant or potentially pose a risk.

4. Authorized representatives

• May act on behalf of non-EU manufacturers to meet the Regulation’s requirements.

CONFORMITY ASSESSMENT AND CE MARKING:

Conformity assessment procedure: The Regulation sets out several modules (control systems) to evaluate whether a product meets the requirements.

1. MODULE A: Internal production contol.

2. MODULE A1: Internal production control plus supervised product testing.

3. MODULE B: EU-type examination.

4. MODULE C: Conformity to type based on internal production control.

5. MODULE D1: Quality assurance of the production process.

Manufacturers may call upon notified bodies (independent, accredited entities) to ensure that these procedures are correctly followed.

CE Marking: Indicates that the product meets the requirements of the Regulation and is suitable for free circulation within the EU. It must be visible, legible, and indelible on the packaging or label. The label must include, among other things, information on the functional category (PFC), composition, instructions for use, precautions, and details of the manufacturer or importer.

MARKET SURVEILLANCE AUTHORITIES AND SAFEGUARD MEASURES

Market surveillance: Competent authorities in each Member State have the power to:

• Inspect and check products on the market.
• Require the withdrawal or prohibition of non-compliant products.
• Collaborate with the European Commission and relevant agencies to ensure uniform application of the Regulation.

Safeguard measures:

• If a Member State detects a health or environmental risk, it may take immediate measures (e.g., ban the sale of a batch).
• It must notify the Commission and other Member States, triggering an EU-level evaluation procedure.

LABELING AND INFORMATION TRANSPARENCY

Clear labeling: Mandatory minimum information on labels, including the functional category, components, instructions for use, safety precautions, etc.

Data sheets (where applicable): For hazardous substances or those that may present certain risks, safety data sheets or detailed technical datasheets must be made availab.

ADAPTATION TO TECHNICAL PROGRESS AND UPDATES

The Regulation provides for the Commission to update the annexes (product functional categories and component material categories) according to new scientific knowledge and technological advances.

New types of fertilizing products may be added, or acceptance criteria for certain raw materials may be changed, if environmental or public health benefits are demonstrated.

CONCLUSION

Regulation (EU) 2019/1009 aims to establish a harmonized framework for the manufacturing, marketing, and use of fertilizing products in the European Union, encompassing quality, safety, and environmental protection criteria. It also drives innovation and competitiveness in the fertilizer sector by incorporating new product categories (including biostimulants), regulating reusable by-products, and applying labelling and traceability requirements, all with the goal of ensuring a high level of protection for human health and the environment throughout the EU.

February 2025

Sun Chemicals Services Team

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