EU Fertilizer Regulation Compliance

On June 5, 2019, the European Commission approved the EU Fertilizer Regulation (EU) 2019/1009, which officially entered into force on July 16, 2022, replacing the former Regulation (EC) No 2003/2003. This regulation broadens the scope beyond mineral fertilizers to include organic fertilizers, organo-mineral fertilizers, soil improvers, growing media, inhibitors, plant biostimulants, and fertilizing product blends. Products must meet these requirements and bear the CE mark to be sold within the EU market.

Product Function and Component Categories

The regulation organizes products into two distinct classification frameworks:

Product Function Categories (PFCs)

These define the seven specific functions of the fertilizing products, ranging from standard fertilizers (PFC 1) to plant biostimulants (PFC 6) and fertilizing product blends (PFC 7).

Component Material Categories (CMCs)

These regulate the 15 types of permitted raw materials, including virgin material substances, compost, fresh crop digestate, microorganisms, and recovered high-purity materials. Manufacturers must note that raw materials used in production must also comply with REACH requirements.

Obligations for Manufacturers

To ensure market access, manufacturers must fulfill several statutory obligations:

• Specification Compliance: Ensure product specifications meet the requirements of the applicable PFC.
• Raw Material Alignment: Verify that all components meet the specific criteria outlined for each CMC.
• Labeling Requirements: Design product labels in strict accordance with the standards set by (EU) 2019/1009.
• Traceability: Maintain comprehensive systems to ensure product traceability.
• Declaration of Conformity: Draft and sign the EU declaration of conformity.

Conformity Assessment Procedures

To register an EU fertilizing product, manufacturers must complete specific conformity assessment procedures depending on the PFC and CMC. These procedures are divided into several modules, including Module A, Module A1, Module B, Module C, and Module D1. Manufacturers are required to prepare comprehensive technical documentation for assessment by a Notified Body, which, upon approval, issues the certificate authorizing the CE mark.

Documentation Requirements

While specific requirements vary by module, the basic technical dossier must include:

• A general description of the fertilizing product.
• A complete list of all component materials used.
• A detailed description of the manufacturing process.
• All relevant test reports.
• A list of applied harmonized standards.

Proregulations' EU Fertilizer Compliance Services

• EU Fertilizer Registration

Assisting manufacturers in navigating the conformity assessment modules and securing the necessary certification for CE marking.

• Renewal of Registration Application

Managing the administrative requirements to maintain your product's compliance status in the EU market.

• Product Benefit Analysis

Evaluating the agronomic or technical benefits of your product to support claims and enhance dossier quality.

• Regulatory Compliance Analysis

Conducting gap analyses on your product's PFC/CMC classifications and raw material compliance to ensure alignment with (EU) 2019/1009.

• Customized Training

Providing tailored sessions for your team on the regulatory updates, technical requirements, and procedural obligations of the EU fertilizer framework.

If you need to ensure your fertilizer products are fully compliant with (EU) 2019/1009 or require assistance with conformity assessment procedures, please contact us.