Scientific regulatory affairs
Regulatory support for biostimulants
Sweden does not have a fertilizer product-related legislation and there is no legislation for biostimulant products. Hence, no specific requirements are set for either fertilizers, including biostimulants. Rather, fertilisers are regulated by the way they are used (for instance through the allowed maximum nitrogen input).
But, Sweden has excluded biostimulants expressively from the PPP legislation and it reminds the amendments made to EU Regulation 1107/2009. There are other pieces of legislation that might have an impact on the marketing of fertilizers though. These are, for instance, the animal by products legislation or the legislation on trading and importing chemicals). There are rules to be observed as regards to products applied to soil, growth substrates, fertilizers and lime. For organic production, specific rules apply for fertilizers, soil improvers and nutrients. As a result, there are many different pieces of legislation that impact the marketing of fertiliser products, including biostimulants.Fertilizers attributable to tariff numbers 25.10, 28.09, 28.35, 31.03 or 31.05 containing cadmium higher than 100 grams per ton of phosphorus may not be marketed or transferred. However, there can be exemptions from that ban for specific reasons. The Swedish Chemicals Agency will evaluate your application. The fee for such evaluation is 15000 SEK (around € 1500,00).In the individual case, the Swedish Chemicals Agency may grant exemptions from the prohibition in the first paragraph, if there are special reasons.Ammonium carbonate fertilizers must not be used.
While there is no dedicated biostimulant product legislation, there are some rules in terms of composition and manufacturing of fertilisers.Organic fertilizers and soil improvers may contain animal by-products, such as manure and bone-meal. There are different requirements for the use and the manufacture of organic fertiliser and soil improvers made from animal by-products. Depending on the source material, these rules differ widely. In most cases, the material is required to be heated (sterilized) before it can be used. This applies, for example, to dead chickens and pigs as well as slaughter by-products of category 2. Processed animal protein is always Category 3 material.Growth media that contain less than 5% (by volume) of processed Category 3 or 2 material (other than processed natural manure) or 50% (by volume) or processed natural manure do not fall under these requirements.There are also environmental requirements for the use of organic fertilizers. These are set out in the Regulations on amendments to the State Agricultural Agency regulations and general advice (SJVFS 2004:62) on environmental considerations in agriculture as regards plant nutrition.Fertilizers may not contain more than 100 g/ton cadmium of phosphorus ( §3 (1998: 944).
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