A fundamental and new aspect of the Biocidal Products Regulation is the common obligation for existing data owners and prospective applicants, to share certain data from tests and studies on biocidal active substances and products submitted to EU authorities. By doing this, the applicants for active substances or biocidal products can reduce costs and avoid unnecessary testing. New studies involving vertebrate animals can be conducted only as a last resort.
Prospective applicants, intending to perform new tests on vertebrate animals, have an obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA. Prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. The Agency will provide the contact details of the corresponding data submitters.
Prospective applicants and existing data owners must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way. All parties must fulfil their data sharing obligations in a timely manner.
Data sharing disputes
An inquiry must be submitted to ECHA, even in cases where the prospective applicant already knows who the data owner is and/or where negotiations have already started. This is the pre-requisite before bringing a data sharing dispute claim to ECHA. A claim must only be initiated as a last resort if the parties are unable to find an agreement.
ECHA can assist in finding a resolution to data sharing disputes between prospective applicants and existing data owners. ECHA's assistance is primarily related to disputes regarding studies on vertebrates. However, in certain situations, ECHA can also assist in disputes related to toxicological and (eco)toxicological studies not involving tests on vertebrates. A prospective applicant initiating a data sharing dispute procedure with ECHA will need to ensure they can demonstrate the efforts made by all the parties to reach an agreement, by submitting appropriate documentary evidence and by (ii) confirming that they have informed the other party.
ECHA's decision will be based on an assessment of the parties' respective efforts to reach an agreement on the fair sharing of the data and their related costs.
The dispute must be solved before new applications for active substance approval or product authorisation can be submitted.