How does the new EU Fertiliser Regulation impact your EU REACH obligations?

How does the new EU Fertiliser Regulation impact your EU REACH obligations?
27 July 2022

On 16 July 2022, the new European Fertilising Products Regulation (FPR) (EU) 2019/1009 came into force, replacing fertiliser regulation (EU) 2003/2003.

This new regulation gives fertiliser manufacturers harmonised access to the CE mark and the European single market. Fertilising products making use of the new framework are called ‘EU Fertilisers’ and all of the components of these products must be assigned categories based on their function in the formulation. 

FPR’s impact on EU REACH

There are two important ramifications of this regulation on the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation:

  1. The new FPR extends the EU REACH registration obligation. The FPR regulation specifies that all substances contained within EU fertilisers must be registered according to EU REACH (Regulation (EC) no 1907/2006). This  requirement applies to components manufactured/imported in volumes greater than 1 tonne. 
  2. The intended use of any of the above substances must be registered as fertilisers regardless of their technical purpose in the formulation. This means that the EU REACH dossier will require additional information from the 10-100 tonnage band. 

What does this mean for you?

If you intend to make use of the new FPR to gain access to the single market you must ensure your formulation’s constituents are not only registered under EU REACH, but that the registrations used for your products components are under the correct use. Registrants must submit dossiers that contain the minimum requirements stipulated in EU REACH Annex VIII (usually only required for substances in the 10 -100 tonnages band), even if organisations only intend to manufacture or import in the 1-10 tonnes band. Registrants must also prepare a Chemical Safety Report (CSR) for the substance. Not complying with the correct regulations can incur fines and/or legal action so it is vital to ensure you and your products are compliant.

To comply with the new FPR you need:
  • To apply a Component Material Category (CMC) to all components of your fertiliser product.
  • Ensure all components are EU REACH registered, to the correct use, with the correct level of dossier detail.
  • Check there are no EU REACH or FPR exemptions that might apply to your substances.

How can the NCEC help?

NCEC’s regulatory team has extensive experience with REACH registrations, the FPR and the standard and non-standard approaches to assess physicochemical, toxicological and environmental fate endpoints. We are already supporting our customers with all aspects of the new FPR and EU REACH registration including Only Representative support. We can also assist with dossier preparation to make sure that all the information within them is permissible under the FPR and REACH. 

Our experts offer bespoke consultancy to help advise the next steps for your organisation helping you navigate the constantly changing regulatory landscape. Please get in touch using the contact us form on the right for more information on how we can help you to stay compliant, minimise the risks of increased costs and business disruption giving you peace of mind.