A biocidal product authorised according to the simplified procedure may be placed on the market in all Member States by a declaration (Art. 13c OBP), without the need for mutual recognition.
Procedure
At the latest, 30 days prior to the first placing on the market, the authorisation holder must notify the Notification Authority Chemicals, via the European Register for Biocidal products R4BP 3, of the biocidal product that was simply authorised in another Member State.
Detailed information on how to use the European Chemical Register can be found on the Internet page Internetseite of the European Chemicals Agency (only in English):
- General introduction to R4BP 3 “BSM Technical Guide: using R4BP 3”
- The specific guide for the authorisation application for a simplified authorisation including the notification of a simplified authorised biocidal product “BSM Application instructions: simplified authorisations”.
Documents for a notification of a simplified authorised biocidal product
In addition to the documents/information required in R4BP 3, a draft label and a safety data sheet would have to be uploaded under “documents” in R4BP 3. If the biocidal product for which authorisation is being requested using the harmonised European procedure is already on the market in Switzerland under a transitional authorisation: its authorisation number (CHAN or CHAC) and proprietary name (IMPORTANT: additional costs will be charged if queries arise)
Period of Validity
Pursuant to Art. 8 para. 1 let. k OBP, the period of validity of a simplified authorised and subsequently notified biocidal product is 10 years.
Fees
A fee of 500 CHF is charged for the notification of a simplified authorised biocidal product.
Remark
The processes and procedures for the authorisation of biocidal products could be modified at short notice. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH.
Last modification 09.03.2017
