Scientific regulatory affairs
Regulatory support for biostimulants
List of plant strengtheners (PPP law) (30 09 2020)
List of products that have not been authorised as plant strengtheners (30 09 2020)
A fertilizer can be placed on the German market if it fits one of the authorized fertilizer types (according to the Fertilizer Regulation (Düngemittelverordnung – DüMV). The DüMV specifies requirements for authorisation, placing on the market, labelling and use instructions for mineral and organic fertilisers, soil and plant improvers and growth substrates, as well as lime and oligoelement fertiliser products.Plant strengtheners (Pflanzenstärkungsmittel) are substance and mixes, including microorganisms, that are (according §2 Nr 10 of the plant protection law):
Products of the second group (to protect from abiotic stresses) include products to reduce evaporation or frost protection. Products which aim primarily at providing plants with nutrients or trace elements to foster plant growth are to be considered as being plant improvers (Pflanzenhilfsmittel) or soil amendments (Bodenhilfsstoffe). Both are regulated by the Fertilizer law.
The following product types are grouped under there generic term "biostimulant":
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.
scientific regulatory affairs | regulatory support for biostimulants
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