Table 1.

Summary of proposed features to be included in a legal provision regulating the production and marketing of biofertilisers in EU

Requirement	Item	Proposal
Definition of biofertiliser		The formulated product containing one or more microorganisms that enhance the nutrient status (the growth and yield) of the plants by either replacing soil nutrients and/or by making nutrients more available to plants and/or by increasing plant access to nutrients
Quality parameters for registration purposes	a. Composition	List of strains included in the product and minimum amount in percent (weight or volume) for each category of PGPM (bacteria, fungi, etc.). The information should include whether or not the strain is registered and in a positive case in which collection/country.
	b. Strain characteristics	Molecular characterisation of the strains used
	c. Additives or other substances	List of ingredients and their amount
	d. Minimum count of viable cells/propagules	A range of values (colony-forming units per gram) valid for the different kinds of PGPM present in the product
	e. Physical form	Solid, liquid, gel, emulsion, etc.
	f. pH	–
	g. C content	Total C
	h. Water content	%
	i. Efficiency in nutrient solubilisation	In case of either bacteria or fungi determined under laboratory conditions
	j. Efficiency in N fixation	For N fixing microorganisms determined under laboratory conditions
	k. Efficiency in plant inoculation	For mycorrhizal fungi (e.g. minimum percentage of root host inoculation points under defined conditions) and endophytic microorganisms
	l. Contamination level	Amount of possible contaminants (e.g. pathogen microorganisms)
	m. Validity	Shelf-life and/or expiry date
	n. Storage conditions	Method of storage
Evaluation dossier	Efficacy studies	Set of studies (reports, scientific papers) demonstrating the efficacy of the product for the crop/s under field and/or greenhouse conditions, with the doses and application methods specified in the label. Possibly to be carried out according to standards similar to Good Experimental Practices (GEP) adopted by the EU for analogous purposes
	Eco-toxicology and toxicology studies	Not compulsory; required only in case of possible risk due to specific additives or strains potentially pathogens for human
Data to be included in the label of the product	Data mentioned in points a, d–k, m–n of quality parameters for registration purposes	Same information as above
	Target crop/s	Name of crop/s
	Application method/s	Description of the method (e.g. broadcasting over the soil surface, in-furrow application, dry dusting or slurring of seeds, spraying, etc.)
	Doses and the timing	Period or the number of applications during the season
	Additional information or precautions	Any additional information that would be useful for efficient use of the product (e.g. soil management practices, chemical fertilisation, spraying nozzles size, sprayer pressure, etc.)