A regulatory challenge for the fertilizer industry
Byline: Dr Thomas Leppin, COMPO EXPERT Head of Regulatory Affairs
With the green movement and the increasingly green European Parliament restrictions, requirements towards fertilisers and other chemical production are on the rise. The new European Fertilising Products Regulation (FPR), in force from 16 July 2022 is just the beginning of a comprehensive change the whole European Chemical Industry will face under the Green Deal.
The new FPR follows the general principle of ‘Circular Economy’ which is one of the goals of the Green Deal. The main objectives of the FPR are the use of organic materials, the re-integration of recycled materials and waste materials into the nutrient cycle and the protection of human health, animal health and the environment.
Against the background of this principle the FPR has become a complex piece of legislation. The regulation distinguishes between ‘Product Function Categories’ (PFC) defining product categories according to their function (fertilizer, liming material, soil improver, growing medium, inhibitor, biostimulant, fertilizing product blend) and ‘Component Material Categories’ (CMC) defining components used for production of the above-mentioned product categories.
The CMC´s comprise inorganic raw-materials, plant parts and extracts, compost, digestate, food industry by-products, microorganisms, nutrient polymers and other polymers, animal by-products, industrial by-products and materials from recycling processes such as precipitated phosphate salts, products from pyrolysis, gasification and thermal oxidation processes.
Some of these bare a risk of importing unwanted contaminants into the soil and threaten human/animal health or the environment. With this in mind, the Commission promotes additional regulatory measures to further reduce potential risks by setting threshold values for potential contaminants in input materials, on top of the existing limit for final fertilising products.
In terms of the Green Deal the ‘Farm to Fork Strategy’ and the ‘Biodiversity Strategy’ will have the most substantial impact on agriculture and the agrochemical industry. With these the EU Commission targets 25% organic farming (7,5% today), 50% reduction of pesticide use, 50% reduction of nutrient losses resulting in 20% reduction in fertiliser use.
For fertilisers, and especially CRF , the potential restriction of micro-plastic goes hand in hand with the requirements of the new European Fertilizing Products Regulation. Coating materials must be biodegradable from 2026 onwards so a substitution of todays´ coating materials is compulsory we lose the environmentally beneficial technology completely. The challenge for the fertilizer industry is to find a coating material that keeps its full integrity for the intended release period but degrades promptly afterwards.
It is reasonable to reduce the release of micro-plastic into the environment. And this is supported by the fertilizers industry. It is difficult, though, to develop a biodegradable coating material without having proper biodegradability criteria or a biodegradation testing method. These do not exist yet and, according to the new regulation, must be developed by the Commission until 2024, two years prior to the ban of non-biodegradable material. Following from this there will only be two years for the industry to finalize this challenging development.
Although the new regulation has its benefits, by including organic fertilizers, organo-mineral fertilizers or biostimulants and allows a combination of products, the most prevailing problem is the necessary conformity assessment prior to placing any product on the European market. Depending on the product’s complexity, the regulation requires it to go through an external conformity assessment, conducted by a notified body that has accreditation for that purpose. However, no notified body exists in Europe, yet – and we have little time until the regulation comes into force. So, it is foreseeable that some products will not enter the market through the new Fertilizing Products Regulation in 2022.
The ambition of the EU Commission to allow customers to have more transparency of fertilising products substantially increases the amount of information given on the label and increases the number of packaging materials needed. The industry requested optional digital labelling early in 2019 and urged the EU Commission for permission. A project was launched at the beginning of 2019 by the Commission to evaluate digital labelling with a potential legislative proposal to be expected in 2023.
The changes in the European regulatory landscape are reflected in the FPR with cross references to other regulatory frameworks, such as the REACH regulation. For many component materials of fertilizing products a prior registration is obligatory. But with the current REACH regulation in place without any of the intended revisions done, it is not possible to register some CMC substances, such as polymers.
One regulation obliges them to do a registration of a certain substance while the other one does not allow them to do so. Such conflicts must of course be solved as fast as possible, in order to avoid market disruptions.
