Biostimulants legislation
Scientific regulatory affairs
Regulatory support for biostimulants
Germany
List of plant strengtheners (PPP law) (01 09 2021)
List of products that have not been authorised as plant strengtheners (30 09 2020)
Legislative framework
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):- Exclusively intended to serve general plant health, unless they are plant protection products according to Article 2 paragraph 1 of Regulation (EC) No. 1107/2009,
- or are intended to protect plants from abiotic stresses
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":
- Plant additives (Pflanzenhilfsmittel): These are substances without any significant nutrient content, applied to act on plants
- Soil amendments (Bodenhilfsstoffe): These are substances without any significant nutrient content, applied to soil with the intention to achieve a biotic, chemical or physical effect
- Plant strengtheners (Pflanzenstärkungsmittel): These are substances or mixes including microorganisms, applied to keep plants healthy or to protect these against harm caused by pests. These fall under the plant protection law.
Useful reference documents
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:- Correct product label in German
- Product type accordance with EU Member State of origin
- Quality requirements must be met with the corresponding Member State
- Product must comply with Annex 2, Table 1.4 column 4 on contaminants and with hygiene requirements as laid out in §5 of the DüMV (if not required in the country of origin)
- Country of origin must be clear and recognisable
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.
Biostimulants
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