Product Dossier

Members of Fertilizers Europe should establish and keep on record a product dossier for all their fertilizer products. A product dossier brings together in one place all the information that the company holds on a product or on ‘family’ of products. The dossier forms a useful checklist, ensuring that all aspects of the lifecycle have been adequately considered. It should be maintained at regular intervals and when new relevant information becomes available.

Information required for making a product dossier will typically be available from different parts of the organization. If not physically combined into one dossier, then clear signposts needs to be in place to show how it can be retrieved and examined.

A product dossier can be organized as follows:

Product specification

  • Product specifications for marketing and sales
  • Manufacturing specifications
  • Identification of impurities in raw materials (heavy metals, radioactivity, etc)
  • Identification of additives and coating materials and their inherent hazards

Hazard assessment, classification and labelling

  • Hazard assessment of the product, including the impact of additives and coating materials, with recording of calculations
  • Hazard classification for transport, storage and use (reference is made to Fertilizers Europe Best Practice Guidance: harmonized criteria for classifying substances and mixtures according to their health, environmental and physical hazards and harmonized hazard communication elements, including requirements for labelling and safety data sheets)
  • Labelling requirements
  • Test results from detonation tests, decomposition tests, oxidation tests, etc

Safety Data Sheets

  • Present and past Data Sheets for the product and for the additives and coating material, with recording of data sources


  • All intended uses and applications for the product
  • Any particular constraints or controls on these uses, the procedures/measures to be taken to conform to them, and the need for customer training

Agronomic data and environmental fate

  • The agronomic benefits of the product should be documented, based on R&D tests, field trials and farmer applications
  • Potential environmental impacts of excessive use of the product
  • Environmental fate of impurities of the product, its additives and coating material


  • Packaging options, limitations on their applicability, and reasons for selection of choice
  • Method of recycling of packaging materials

Safety and security precautions

  • Specific safety and /or security restrictions on the manufacturing, handling and use of the product and measures that can be taken to prevent incidents

Information to distributors, logistics operators and farmers

  • Information to the distributor, logistics operator and to farmers, such as information leaflets and training material. Reference is made to Fertilizers Europe Best Practice Guidance documents.


  • Description of markets under consideration, such as country, distributors, agents, customers, tonnages, etc
  • Specific product and market regulations for the countries of concern

Specific regulations

  • Specific product, transport, storage and market regulations for the countries of concern, other than specified above

Improvement plans

  • Summary of actions for further reducing any risk associated with the product at any stage

Review process

  • Regular internal review of product dossiers, with recording of measures taken

Registration file for EU approval

  • File with official information submitted to authorities for registration as EU fertilizer