Written Communication according to § 2 (2) and § 4 (2) Biocides Act-Ordinance on Existing Active Substances

The written communication is an important prerequisite for the placing on the market of the old biocidal product during the authorisation procedure. Therefore information according to § 13 (1) No 1 and 4 of the Act on Biocidal Products and according to Annex IIB section I and X and, if applicable according to Annex IVB Section I and X of the Biocidal Products Directive are necessary. In case of a registration procedure information according to § 14 (1) No 1 and § 9 (2) No 1 to 3 and 6 to 7 of the Act on Biocidal Products.

Thus a written communication consists of:

  • Proof as to the product's placement on the market in Austria before the active substance's inclusion in Annex I/IA (for an existing product) in paper and as an electronic file (e.g. copy of invoice).
  • Updated Material Safety Data Sheet in German language in paper and as an electronic file.
  • Label of the Biocidal Product in German language in paper and as an electronic file.
  • Announcement that an application for mutual recognition of an authorisation/registration will besubmitted within the designated deadline in paper and as an electronic file.
  • Application Form, Part I (R4BP document concerning the announcement of an application for authorisation/registration by way of mutual recognition ).
  • The summary dossier as an electronic file as submitted to the Reference Member State
  • „Letter(s) of Access“ concerning the active substance and/or the biocidal product, if applicable, in paper and as an electronic file.

Deadlines

The submission of the written communication is possible at the earliest three month before or until the date written in row 4 of the Annex the Ordinance on Existing Active Substances (=Date of Inclusion of the active substance in Annex I/IA of the Biocidal Products Directive). 

If no written communication is sent the further placing of the product on the market in Austria is only allowed for a period of 6 months after the date written in row 4 for the concerned substance/product type combination.

Stocks are allowed to be delivered for a period of further 6 months, if they have been established after 6 months after the date written in row 4 for the concerned substance/product type combination in Austria.

Last update: 20.07.2010