Application for Authorisation AN

This type of authorisation applies to products that contain at least one notified active substance, for which a decision on inclusion in the list in Annex 1 or 2 of the Ordinance on Biocidal Products (OBP; SR 813.12) is still outstanding.

The other active substances of the product are included in one of these lists (notified active substances or Lists of Annex 1 or 2).

Important: If the last notified active substance of a biocidal product has been approved (included in the Lists of Annex 1 (XLS, 110 kB, 01.03.2018) or Annex 2 (XLS, 712 kB, 25.06.2019) of the OBP), then the authorisation owners of an authorisation AN have various options that are presented under the Transitional regulation (Link to Transitional regulation).

Procedure

An application for authorisation AN must be submitted to the Notification Authority for Chemicals via the Chemicals Register RPC. Explanations for the electronic form may be found in the guidance document guidance (PDF, 2 MB, 04.04.2017). On the “Documents” tab in the RPC the following documents should be uploaded:

Please note: documents with confidential content should have an access level “author & federal authorities”. The access level can only be assigned after the document has been uploaded.

a. Signed printout of the last page1 of the confirmation from the product register as a PDF
b. a draft label (incl. description and instructions for use)
c. safety data sheet
d. if applicable proof of efficacy (disinfectants and wood preservatives)
e. possible evidence for the labelling of the product
f. The completed document “Additional information (RTF, 1 MB, 27.02.2017)
g. Excel-Template (XLSM, 290 kB, 10.10.2017) containing the information on the active substance supplier listed on the art 95 list (see provision of evidence under art 62d)

After transmission of the completed electronic form via the Chemicals Register, an email with the following information has to be sent to the Notification Authority for Chemicals (cheminfo@bag.admin.ch):

  • Trade name and the CPID number of the biocide
  • Specifying, that the application concerns a first application AN

Processing period

Complete applications are generally processed and a decision given within 60 days. Please note the legal holidays (among others from 15 July to and with 15 August, art. 22a APA).

Period of Validity

The authorisation is valid for 6 months after the last active substance of the biocidal product is included in the lists of Annex 1 or 2 OBP. After the last active substance has been included the product may still be placed on the market for up to 360 days and supplied to end consumers for additional 360 days. Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment. Should the product still remain on the market (Transitional provisions).
If a decision is taken by the EU Commission to deny the inclusion of the active substance into the Annex 1 BPR or into the Union lists of approved active substances, then the authorisation will be revoked by the Notification Authority. After the decision of the Commission the product can be placed on the market for up to 360 days and supplied to end consumers for additional 360 days. Professional or commercial use is not limited insofar there is not an unacceptable effect on humans, animals and the environment.

Fees

  • Wood preservatives and disinfectants with proof of efficacy: CHF 1200.-
  • Other product types: CHF 1000.-

If the dossier is incomplete then surcharges will be levied.

Last modification 04.09.2018

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