Introduction
Regulation (EU) No. 2019/1009, also called Fertilising Products Regulation (FPR), came into effect on 16/07/2022. It replaced Regulation (EU) No. 2003/2003, which was limited to mineral fertilisers, to cover a wide variety of fertilising products (plant biostimulants, inorganic and organic fertilisers, liming material, soil improver, inhibitors and growing media). This new harmonised EU regulation is a promising tool to market fertilising products in the whole EU.
The FPR is structured in 4 parts. The first part describes the Component Material Categories (CMC) which the components of an EU fertiliser must belong to. The second part lists the Product Function Categories (PFC) and the related requirements to which the EU fertilisers must comply. The third part is related to the assessment of the conformity of the fertilising products with an appropriate procedure called «module». The last part describes the labelling requirements that must respect all EU fertilisers before being placed on the EU market.
Since its implementation, the regulation has undergone several changes, including the publication of the delegated regulations pertaining to:
- Requirements applicable to EU fertilisers containing inhibitory compounds and post-treatment of digestate (2022/1519)
- Addition of highly pure materials as a category of constituent materials for EU fertilisers (2022/1171)
- Agronomic efficiency and safety criteria for the use of by-products in EU fertilisers (2022/973)
- Addition of materials from pyrolysis and gasification as a category of constituent materials for EU fertilisers (2021/2088)
- Addition of materials obtained through thermal oxidation and their derivatives as a category of constituent materials for EU fertilisers (2021/2087)
- Addition of precipitated phosphate salts and their derivatives as a category of constituent materials for EU fertilisers (2021/2086)
- Amendment, for the purpose of technical progress adaptation, of Annexes I, II, III, and IV (2021/1768).
As such, the original text featured 12 CMCs whereas the current FPR allows for the use of 15 CMCs in the composition of an EU fertiliser.
Main difficulties faced: Economic operators should be aware of the following requirements which could be limiting for the marketing of their fertilising products under the FPR.
1. Animal by-products in EU fertilising products
Regarding the CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009 (Animal by-products, ABP), the FPR should be amended to include a table listing the animal by-products having reached the end point in the manufacturing chain, as determined in accordance with Regulation (EC) No 1069/2009. The regulation defines the concept of “end point” beyond which the material no longer needs to be processed to be considered as safe. Only these animal by-products will be authorized for use in an EU fertiliser. Regulation (EC) No 1069/2009 has been amended by the Delegated Regulation (EU) 2023/1605 as regards the determination of end points in the manufacturing chain of certain organic fertilisers and soil improvers. This delegated regulation provides the requirements to reach the end point for several animal by-products such as compost, processed manure, glycerine, processed animal proteins, meat and bone meal, blood products, hydrolysed proteins, dicalcium and tricalcium phosphate. It is still required to wait for the amendment of the FPR before using these animal by-products in the EU fertilisers. In the meantime, incorporation of animal by-products in an EU fertiliser is not permitted. There is currently no date indicated for the publication of this amendment.
2. Microorganisms in microbial plant biostimulants
Concerning microbial plant biostimulants, the positive list of microorganisms that can be used in an EU fertilising product under the CMC 7 includes 4 types of microorganisms : Azotobacter spp., Rhizobium spp., Azospirillum spp. and mycorrhizal fungi. Other microorganisms are not allowed in an EU fertiliser. A survey was conducted in 2022 to collect stakeholder requests for the addition of new microorganisms and new CMCs in the regulation. Following this, a call for tenders was made in the summer of 2023 to find an organization capable of performing the studies required to add new microorganisms in the FPR. The proposals to include new microorganisms in the FPR are currently under evaluation as regards the absence of risk to Human and animal health and the environment, and the justification of agronomic efficiency.
The following information is required to fulfil these criteria :
- microorganism name
- taxonomic classification including procurement method
- safe production, conservation and use => scientific evidence
- taxonomic relationship with microorganisms already in line with Qualified Presumption of Safety
- product process including processing methods
- identity and levels of residual intermediates, toxins and metabolites in the component material
- natural occurrence and environmental fate.
The amendment of the FPR to add new microoganisms is not expected to be published before 2025-2026.
3. Regulation (EU) 1907/2006 on Registration, Evaluation & Authorisation of Chemicals (REACH)
Substances included in the following CMCs must be registered under REACH:
- CMC 1: Virgin material substances and mixtures
- CMC 3: Compost (Composting additives only)
- CMC 4: Fresh crop digestate (Digestion additives only)
- CMC 5: Digestate other than fresh crop digestate (Digestion additives only)
- CMC 6: Food industry by-products
- CMC 11: By-products within the meaning of Directive 2008/98/EC
- CMC 12: Precipitated phosphate salts & derivatives (struvite)
- CMC 13: Thermal oxidation materials & derivatives (ashes)
- CMC 14: Pyrolysis & gasification materials (biochar)
- CMC 15: Recovered high-purity materials
The FPR indicates that these substances:
“shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:
(a) the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and
(b) a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product, unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation.”
The FPR sets up more restrictive requirements compared to the REACH regulation. REACH requirements under the FPR are called «REACH +». These «REACH +» requirements include as follows :
- REACH registration becomes compulsory for all substances even if they are produced or imported in quantities lower than 1 tonne per annum (TPA), whereas REACH regulation requires registration for substances above this minimum tonnage threshold.
- Substances produced or imported in quantities between 0 and 10 TPA must fulfill the same requirements as the ones of the tonnage band 10-100 TPA, including the provision of a Chemical Safety Report.
- Several REACH exemptions are not applicable to substances covered by the FPR, for example by-products and substances which result from a chemical reaction.
- The substances must be registered under the chemical Product Code (PC) 12 : Fertiliser, and the Sector of end use (SU) 1 : Agriculture, forestry and fishing.
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 FPR. EBIC also published a position paper and proposed several actions to reduce the burden of REACH registration in specific cases. However, the REACH regulation was due to be amended at the end of 2023, but this update has been postponed until the end of 2024 or 2025. Potential changes to the RPF will only be examined once the amendment to the REACH regulation has been published.
4. Efficacy of plant biostimulants
Plant biostimulants must demonstrate the effects which are claimed on their label. Technical Specifications (TS) have been published in 2022 to help manufacturers assessing these effects and comply with the FPR. The 5 technical specifications are listed below:
- EN 17700-1: Plant biostimulants – Claims – Part 1: General principles
- EN 17700-2: Plant biostimulants – Claims – Part 2: Nutrient use efficiency resulting from the use of a plant biostimulant
- EN 17700-3: Plant biostimulants – Claims – Part 3: Tolerance to abiotic stress resulting from the use of a plant biostimulant
- EN 17700-4: Plant biostimulants – Claims – Part 3: Tolerance to abiotic stress resulting from the use of a plant biostimulant
- EN 17700-5: Plant biostimulants – Claims – Part 5: Determination of availability of confined nutrients in the soil or rhizosphere
The technical specifications are still under improvement. The final versions should be delivered in April 2024 under the form of Harmonised European Standards. Publication of these harmonised standards triggers “presumption of conformity”. Users applying these standards can therefore assume that they are acting in compliance with the essential requirements of the FPR.
It is important to study the mode of action and the effects of the plant biostimulants on plants before implementing the efficacy trials. The trials design must be established in accordance with the Technical Specifications, otherwise the results may not be valid.
For example, if a biostimulant has an effect on the tolerance to drought stress, the trials must include:
- a positive control (with stress conditions so under drought stress)
- a negative control (no stress so under normal irrigation conditions)
- the assessment of one or several agronomic markers (such as plant or root biomass, root length, leaf number, percentage germination, crop yield, etc).
If a negative control cannot be implemented, it is required to evaluate a stress marker before and after the event of the stress in the positive control (for example the relative water content which is a stress marker for drought conditions). Then one or several agronomic markers must be assessed.
To evaluate a plant biostimulant which improves the nutrient use efficiency, the trials must include the measurement of the nutrients in the whole plant or on a specific plant part (root, foliage or harvested products) and the biomass of the same part (whole plant or specific plant part) or the crop yield. These parameters are necessary to calculate several indices required by the Technical Specification such as the Nutrient Export (NE) and the Internal utilisation Efficiency of a nutrient (IE).
5. Creation of new Harmonised Standards
In the same way as plant biostimulants, other types of fertilising products such as fertilisers and soil improvers, need the creation of Harmonised Standards to evaluate their characteristics in accordance with the FPR. However, the standardisation request has been delayed and the harmonised standards are expected to be published in 2027 only. It will be also necessary to create Harmonised Standards for the new CMCs recently included in the FPR (CMC 12, 13, 14 and 15).
Conclusion
The FPR is a valuable tool to market EU fertilising products in the whole EU. However, some evolutions are expected/needed and national regulations remain the only possible way to register and market certain types of fertilising products which are not covered by the FPR so far. This alternative registration pathway is complex because each country has its own regulation on fertilising products (only available in national language in several countries) with specific requirements, data generation, validity of authorisation, etc. However, once a fertilising product is lawfully commercialised in an EU country, the Regulation (EU) 2019/515 on Mutual recognition of goods lawfully marketed in another Member State makes it possible to access the market of several EU countries with a simplified procedure.
For more information on marketing procedures via the FPR or in the different European countries, the Staphyt Regulatory team dedicated to plant nutrition is here to advise you and help you define the best possible strategy.
Depending on your product and target markets, our experts will be able to define the most appropriate regulatory route, while optimizing cost and time.
Contact our sales manager Geoffroy MOULIN for more information.
Geoffroy MOULIN
+33 (0)6 64 35 08 54
