On March 8, 2022, the Italian Directorate for Hygiene and Safety of Food and Nutrition has issued and published a procedure for the application of Article 34 of Regulation (EC) no. 1107/2009.
Italy thus joins the European Member States (i.e. France, Spain, Greece, Austria, Ireland, Denmark) able to guarantee market access to operators who fall within the conditions provided for by this article of the Regulation.
Article 34 provides that an applicant may ask for the authorization of a plant protection product by referring to public and unprotected data relating to another identical or similar product, thus gaining the exemption from the need to generate new ones.
Two elements are mandatory to take advantage from this scenario:
– Identity / comparability of the two formulations (the reference one and the one to be registered); this grant the chance of a “bridging” in the risk assessment which deletes the need for new studies to be set (rather expensive studies, which do not fall within the economic faculties of many companies).
– Data available both for the active ingredient and the product, in the Member State in which the application for authorization is presented. This availability may result either from the occurrence of the expired data protection itself, or – alternatively – through the evidence of access through the LoA (Letter of Access) tool.
It is expected that the applicability of this part of the legislation also in Italy will determine the entry on the agrochemical market of new, interesting players.
It is desirable to keep the focus on the request of several Member States, calling for homogeneity in this applicability, to be achieved with the development of a single European guideline.
Link to the News published on the Italian portal of the Ministry of Health
Our PHYTO Unit offers assistance for the management of projects pursuant to art. 34. Do not hesitate to contact us.