The EU has recently approved the draft of a new regulation, which lays down the rules on EU fertilising products. Currently being finalized by the European parliament, Regulation (EC) No. 2016/0084 will come into force by 2022 and include all types of fertilisers, including mineral, organic, biostimulants, growing matters and industry by-products.
“Existing legislation does not cover all of the fertilisers on the EU market,” says Philippe Kuenemann, TSG’s Managing Director, France. “In addition, there is no harmonized legislation to guide the placing of products such as biostimulants on the European market. This new regulation will help make it more efficient for companies to register their products across Europe, as well as create more opportunities for companies to develop innovative fertilisers.”
The regulation defines a ‘fertilising product’ as “a substance, mixture, micro-organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency”.
The new regulation gives a clear definition of biostimulant products, which were previously at the border between fertiliser and plant protection products. Biostimulants will be excluded from the scope of EU regulation 1107/2009, which regulates plant protection products.
Plant biostimulants will now only be considered a fertiliser and specifically as ‘a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
(a) Nutrient use efficiency
(b) Tolerance to abiotic stress
(c) Quality traits
(d) Availability of confined nutrients in soil or rhizosphere
In light of this, biostimulants will be in Category 6 of the seven new Product Function Categories (PFCs) defined by the future regulation. Category 6 is divided in two sections:
A. Microbial plant biostimulant
B. Non-microbial plant biostimulant
This distinction helps to establish the need for studies to be included in the submission dossier.
Compliance with contaminants
Additionally, biostimulants will have to comply with contaminants specifications as follows:
(a) Cadmium (Cd): 1,5 mg/kg dry matter
(b) Hexavalent chromium (Cr VI): 2 mg/kg dry matter
(c) Lead (Pb): 120 mg/kg dry matter
(d) Mercury (Hg): 1 mg/kg dry matter
(e) Nickel (Ni): 50 mg/kg dry matter, and
(f) Inorganic arsenic (As): 40 mg/kg dry matter
The copper (Cu) and the zinc (Zn) content in a plant biostimulant must not exceed 600 mg/kg dry matter and 1500 mg/kg dry matter, respectively.
Plant biostimulants shall also have the effects claimed on the label for the target plants. Authorities can check on efficacy and label compliance at any time.