REACH+ & FPR: a challenge for innovative fertilising products

Regulation (EU) 2019/1009 – the Fertilising Products Regulation (FPR) — cross-references the REACH Regulation (EC)1907/2006 but imposes stricter requirements for substances produced in amounts less than 10 tonnes per year if they are used in EU Fertilising Products. We use the shorthand “REACH+” to refer to the fact that the Fertilising Products Regulation requires a Chemical Safety Report and data equivalent to what is specified in Annex VIII of Regulation (EC) 1907/2006 (the REACH chemical regulation), even for substances approved for use in food and/or feed or those produced under 1 tonne per year.

Giuseppe d’Ercole introduces Theodora Nikolakopoulou at teh May 2023 workshop on REACH+ in the FPR.

According to EBIC’s calculations, these requirements will be onerous in terms of both time and cost for manufacturers, with disproportionate effects on small companies and innovative substances that do not have a large market to offset the costs of data requirements. Furthermore, they will multiply requirements for animal testing. Yet, there is no evidence there will be any gain for health and safety, especially for substances that have already been approved for use in food and/or feed.

On 16 May 2023, EBIC convened a workshop entitled “Innovation & safety of EU Fertilising Products: REACH & FPR” to discuss difficulties companies are having meeting the “REACH+” requirements specified in the EU Fertilising Products Regulation.

Download the presentations

  1. Theodora Nikolakopoulou, Desk Officer, DG GROW, Unit F2: Bioeconomy, Chemicals & Cosmetics at the European Commission — “Setting the context for REACH+ requirements in the FPR: highlights from key COM policies”.
  2. Sara Tormo, Rovensa Next and member of EBIC, “Tonnage bands and Chemical Safety Reports (CSR): impacts on low-volume and innovative substances.”
  3. Riccardo Mulato, Yara on behalf of Fertilizers Europe, “Substances approved for food and/or feed.

Impacts of the new rules on industry were further illustrated when the co-leaders of EBIC’s Project Team on REACH+ — Gianluca Bini, Biochim, and Giuseppe D’Ercole, Valagro — presented results of a recent survey conducted among EBIC and Fertilizers Europe members.

(Clockwise from upper right) S. Tormo, K. Sukalac, T. Nikolakopoulou, and R. Mulato discuss the case studies and the difficulties at the May 2023 workshop “Innovation & safety of EU Fertilising Products: REACH & FPR”.

The last hour of the half-day event was dedicated to a panel discussion on “How to ensure the safety of fertilising products proportionately?” Theodora Nikolakopoulou was joined on the panel by Jaroslav Houček of the Czech national authority; Giel Tettelaar from EFCI Register, a conformity assessment body accredited under the Fertilising Products Regulation; and

Nicolas Willaume, EBIC Board Member and Global Advocacy Manager , ICL (which is also a member of Fertilizers Europe).

There was consensus that the Fertilising Products Regulation needs improvement to get the balance right between protecting people, animals, and the environment while ensuring a pragmatic and feasible approach that ensures innovative fertilising products reach the greatest number of farmers.

Further reading

  1. EBIC Position paper “REACH [Regulation (EC)1907/2006] requirements in the FPR