Trial permit and notification
If you want to conduct a trial for a use that is not yet authorised, then you must report this to the European Chemicals Agency (ECHA ) and registrer the data for trial in R4BP.
The following text on conducting such trials has been taken directly from the Regulation:
“Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request. Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur. The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment. The person concerned shall make available any other information requested by the competent authorities. In the absence of an opinion from the competent authority within 45 days of the notification referred to in the first subparagraph, the notified experiment or test may take place.”
The scope of “research and development” provisions under article 56 of the BPR, has been clarified the Guidance: Scope of R&D provisions under Article 56 of the BPR. The trial has to take place in the Netherlands. The Ctgb code for this type of application is PB, the ECHA code is ET-NOT.
The legal basis
The legal basis for this notification is Article 56, third part, BPR (EC)no. 528/2012.
Application type criteria
- This derogation is meant for trial-purposes. By completing and signing the application form the applicant declares that this is a trial. This derogation can only be used for biocidal products.
- The trail must be carried out in the Netherlands.
- The risk for human and environment should be restricted.
- The trials must be conducted in accordance with the appropriate guidelines.
- The trial cannot be started before the date stated in the decision and until the Ctgb has been informed about the trial locations. The start point of the trail is the point in time when the product is actually used. The applicant is allowed to start the trial when the approval of the Ctgb has been received and the Ctgb has been informed about the trial location.
- When trials are outsourced to research institutions, research centers, other firms or persons, then this institutions, firms or persons always need a copy of the permit from the holder of the permit.
The trail must be reported to the European Chemicals Agency (ECHA) by uploading the Ctgb notification form for trials (form PB) in R4BP (no European template is available ).
The trial may be carried out 45 days after the notification and the payment. From that moment the trial locations must be known to Ctgb. If the Ctgb agree with the notification, the notification will be approved in R4BP. If the Ctgb does not agree with the notification of the trial, you get an decision by post with restriction(s) for the trial or an rejection of the notification. Of course you also find this communication in R4BP.
Instructions for submission
Use the Notification form for trials with unauthorised biocidal products and/or unauthorised uses.
Duration period product trial permit
The trial starts at the point in time when the product is actually used. The trial must be carried out in a restricted period, as defined in the permit.