What is Module D1?
Last reviewed 5 October 2026. Source: Regulation (EU) 2019/1009, consolidated text of 1 July 2026.
In simple words
Module D1 is about your whole production process, not only one design. You run a quality system for production, final inspection and testing. A notified body approves the system and then checks it regularly. You can use Module D1 for almost every EU fertilising product. The exception is high-nitrogen ammonium nitrate fertilisers.
Words in this article
- Module
- One of the fixed routes for conformity assessment. The regulation has Module A, Module B followed by Module C, Module D1 and Module A1.
- Quality system
- The written rules, checks and records that a company uses to make products of steady quality.
- Notified body
- An independent organisation that an EU country has approved to check products or quality systems. Some modules need one.
- Technical documentation
- The set of documents that show the product follows the rules. It includes the product description, the materials, the production process, test reports and the label.
- CMC (component material category)
- A group of materials a product can be made from. There are 15 groups: virgin material substances and mixtures (CMC 1), plants, plant parts or plant extracts (CMC 2), compost (CMC 3), fresh crop digestate (CMC 4), digestate other than fresh crop digestate (CMC 5), food industry by-products (CMC 6), micro-organisms (CMC 7), nutrient polymers (CMC 8), polymers other than nutrient polymers (CMC 9), derived products (CMC 10), by-products (CMC 11), precipitated phosphate salts and derivates (CMC 12), thermal oxidation materials and derivates (CMC 13), pyrolysis and gasification materials (CMC 14) and recovered high purity materials (CMC 15).
- High-nitrogen ammonium nitrate fertiliser
- A solid fertiliser based on ammonium nitrate with a high nitrogen content. It has its own route, Module A1.
What does the quality system cover?
The system must cover:
- your quality goals and who is responsible for what;
- how you make and check the product;
- the tests you do before, during and after production, and how often;
- your quality records, for example inspection reports, test results, calibration data and training records;
- how you check that the system works;
- written procedures and instructions.
Extra duties for some materials
For materials in CMC 3, 5, 12, 13, 14 and 15, the regulation has extra duties. Senior management must give enough people and equipment. Management must name one responsible person. The company must do an internal audit every year, or sooner after a major change. The records and tests are described in more detail.
Approval by the notified body
You send an application to a notified body that you choose. The auditors visit your site. They also read your technical documentation.
Checks after approval
The notified body returns for regular audits and writes a report. For CMC 3, 5, 12, 13, 14 and 15 it audits every year and takes samples of your product. It may also visit without warning. You must give access to the production, inspection, testing and storage areas and to your documents and records.
How long do you keep documents?
Keep the technical documentation for 5 years after the product is first sold in the EU.