Registration dossiers for substances and products: plant nutrition

Registration dossiers for active substances and products plant nutrition logo

The marketing of fertilizers and growing media is regulated at European and national level according to the requirements of each country. Depending on the type of fertilizer, the regulations are either European or national.

At European Union level, only inorganic fertilizers are considered in Regulation (EC) No.2003/2003.

Fertilizers and growing media not complying with these regulations are marketed according to national legislation.

At the national level, regulations are different. Except for inorganic mineral fertilizers governed by Regulation (EC) No.2003/2003, regulations must be considered on a case-by-case basis for each product and in each Member State.

In addition, the regulation requires a specific provision for placing the fertilizers on the market by mutual recognition based on Regulation (EC) No.764/2008. If the product is legally placed on the market in a Member State of the European Union as a fertilizer, adjuvant for fertilizer or as a growing media, it may be placed on the market in another Member State provided that the specific national rules of that Member State are respected.

For several years, Staphyt Regulatory team has led to the registration of several fertilizers and growing media in France and in various European countries as well.

You need to

  • Define a marketing strategy for your product in various Member States of the European Union,
  • Define and follow your experimental program (efficiency, selectivity),
  • Select GEP experiment providers and COFRAC accredited laboratories (program 108) or an equivalent accreditation system (ISO 17025: 2005),
  • Prepare and submit authorisation dossiers in France and in various European countries,
  • Prepare any other type of file: extension of use, change of composition, trial permit, mutual recognition, etc.

Our expertise

  • Check the marketing opportunities for your product in France or any other European country,
  • Assess existing studies and identify missing or critical data for compiling your dossier,
  • Monitor GEP efficacy trials or any type of analysis and studies carried out by accredited COFRAC or ISO 17025: 2005 laboratories: selection and follow-up of the contractor, review of the study plan and the draft report,
  • Prepare authorisation dossiers including risk assessments and summaries of toxicity, ecotoxicity, environmental, efficacy and safety studies,
  • Identify the CLP classification of your product and prepare the label and SDS,
  • Submit the dossiers to the Competent Authorities and maintain contact with them for a smooth evaluation process,
  • Maintain contact with the authorities, if necessary, before or after the submission of the dossier until the authorisation has been obtained and adapt to their new requirements.

You want to build your registration dossier in another business area?