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Active substance & Product Registration dossier: plant nutrition

Registration dossiers for active substances and products plant nutrition logo

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

At European Union level, only inorganic fertilisers were considered in Regulation (EC) No.2003/2003 so far. The requirements of Regulation (EC) No. 2019/1009 are currently being defined. Fertilisers and growing media will still be possible to register or market according to national legislation.

At the national level, regulations are different and must be considered on a case-by-case basis for each product and in each Member State.

We can assist you with the following, for chemicals and biologicals products:

  • Strategic advice, including regulatory definition
  • Advising on the optimum strategy
  • Data Gap Analysis – to identify the required studies, costs and timeline
  • Experimental use permit
  • Study placement, generation & monitoring (mode of action definition, proof of concept, efficacy in field)
  • Checking REACh compliance of substance and coformulants
  • Product compliance check, notification
  • Product registrations dossiers (including initial authorisation and mutual recognition)

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