Trial permit and notification

If you want to conduct a trial with a not yet authorised product or 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 register the data for trial in R4BP with the ‘’Notification form for trials’’.

Characteristics

If you want to conduct a trial with a not yet authorised product or 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).

The legal basis

The legal basis for this notification is Article 56, third part, BPR: Regulation (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 the derogation is meant  as a prerequisite to conduct a trial. This derogation can only be used for biocidal products;
  • The trail must be carried out in the Netherlands;
  • The risk for humans 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 centres, other firms or persons, then this institutions, firms or persons always need a copy of the permit from the holder of the permit.

Trial locations

If the trial locations are unknown at the time of filling in the notification form, you can e-mail them at a later stage to Ctgb and IL&T (see: www.ilent.nl/contact). You may start the trial, after receiving the decision, one day after you send this e-mail.

Permit for trial purposes meant for application in and near waterbodies

In case a permit for trial purposes is meant for an application in and / or near the water, a water permit must be applied for at the Dutch Water Authority. This permit is required because article 6.2. Paragraph 1 of the Water Act stipulates that it is prohibited to bring a harmful substances into a surface water body without a permit. In addition, the monitoring plan that is necessary to monitor the effects of the application on aquatic organisms must be submitted to the Dutch Water Authority for assessment. It is important to monitor the effects on the organism to be controlled in combination with the other aquatic organisms living in the water.

Notification process

You have to report the trial to the European Chemicals Agency (ECHA). For more information see Instruction for submission. The Ctgb will review the notification.

Decision

If the Ctgb agrees with the notification, the notification will be approved in R4BP (without a decision document). If the Ctgb imposes restriction(s) or did not approve the notification, you get an decision by normal post. Of course you also find this decision documents in R4BP.

Do you not agree with the decision we have made? See: Objection and Appeal

Instructions for submission

The sending of the application

You have to create a IUCLID dossier and submit it to ECHA and the national authorities through R4BP. In R4BP you have to upload the Ctgb Notification form for trials. After finishing the report in R4BP you become an invoice from Ctgb because we will review the notification.

Important remark

You are allowed the make a minimal IUCLID file (a fake file), because we don’t use the IUCLID file for this type of application.

Fees

For this kind of application you have to pay application fees.