Scientific regulatory affairs
Regulatory support for biostimulants
List of Fertilisers (2016)
List of fertilisers amended (2017)
The Fertiliser Product Act 539/2006 covers the EC Fertiliser regulation 2019/1009 and is about making sure that fertilisers are safe for the environment and humans, including their placing on the market and their use. In its definition of fertiliser products liming materials, soil improvers, growth substrates, as well as microbial products.
Soil improvers are substances added to the ground to maintain or improve its physical properties or biological activity. There is specific Finnish guidance on the preparation of soil improvers. They may contain primary and secondary nutrients. If they contain microbial preparations they fall under fertiliser type 4A1.
Organic soil improvers are made of organic raw material and will contain a minimum of 20.0 % of it. They may also contain primary and secondary nutrients.
Soil-structure enhancing substances are low in nutrients are can be added to fertilisers. Raw materials and additives have to be mentioned on the label.
Microbial preparations can contain one or more known microbial strains which have been found to have a specific growth of other beneficial effect.
The amount of contaminants or other harmful substances that can be present in a any fertiliser preparation is limited and specified.
A new fertiliser type can be applied for with the Finnish Food Safety Authority. In general, all claims must be verifiable. Claims that suggest that the fertiliser/biostimulant prevents or treats plant disease must not be made.
If there are justified reasons to believe that a fertiliser product or its raw material poses a significant risk to human or animal health or to the environment, it can be removed from the market and farm stocks.
Fertilisers imported from other EU Member States or outside the EU must be notified to the authorities (Food Safety Authority) prior to the import. The notification does not apply to EU fertilisers.
Mutual recognition is possible and explained here.
Regulation 24/11 on fertiliser products from 2011 lays down the various fertiliser product types as well as the requirements in terms of composition, labelling etc. There are two fertiliser type lists, one from 2016 and one from 2017, the latter is the latest update with new types of fertilisers.
Cadmium is limited to 1,5 mg/ kg dw; in ash fertilisers, the concentration must not exceed 2,5 mg/kg dw. The allowed concentrations for Arsenic and Selenium are also limited. More details are found in the Regulation 24/11.
Regulation 24/11 contains specifications on allowable and minimum concentrations of primary, secondary and micro-nutrients, including labelling instructions. Tolerances, contaminants, pathogens, and handling of plant material requirements are found in this regulation.
The last amendment dates from 1 August 2018, where it was decided that phosphonates must not be not allowed in fertiliser preparations. Phosponate residues may not exceed 0,5% in weight. (Amendment 12/18 of the Regulation of the Ministry of Agriculture and Forestry on fertilisers products (24/11), section 2, as it reads in regulation 21/15).
Placing a biostimulant on the German market
The authorization of fertilisers or the German market is handled at federal level by the BMELV ( i). There is no formal application procedure. Information can be found on the website of the BMELV.The states are responsible for the implementation of the fertilizer regulation.
For Plant Strengtheners (Pflanzenstärkungsmittel), the situation is somewhat different, as these are regulated under §45 of the German Plant Protection law; the BVL being the competent authority.Also, before a plant strengtheners be placed on the market the BVL has to be notified beforehand, by the means of a specific notification form and its accompanying documents.
And what about Mutual Recognition?
Biostimulants that are on the market in a different EU Member State can be placed on the German market if they comply with the provisions on contaminants in the German Fertilizer Regulation DüMV.In order to enable mutual recognition, the following criteria must be met:
If these requirements are met, a fertiliser already authorised in a different Member State can be placed on the market in German without any further authorisation or registration.
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SCIBASICS is a Belgian company with headquarters located in Rue Alphonse Libert 6A, B-4520 Bas-Oha and registered in the Belgian registry of under number BE0893 600 424.
SCIBASICS provides various services related to product authorisation in the field of mainly plant protection products, biocides for veterinary use and fertilisers. We help our clients with dossier set up and submission, product mapping and positioning, label compliance checks and label set up, intelligence and strategic decisions.
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