Product marketability / SDS
In general, biocidal products should neither be made available on the market nor used unless authorised in accordance with Regulation (EU) No 528/2012 (BPR). The principles concerning the authorisation of biocides are listed in Articles 17 - 24 of the BPR.
Marketability of Biocidal Products
The first step of finding out whether a product is marketable or not is to obtain information about the status of the active substances contained in the product.
Biocidal products containing new active substances cannot be authorised until the active substances they contain have been approved, unless a provisional authorisation has been granted in accordance with paragraph 2 of Article 55 of the BPR.
Products containing existing active substances which are listed in Part 1 of Annex II to Regulation (EU) No 1062/2014 (Review Regulation) – as well as in all amendments to this regulation - and for which a decision on approval or non-approval has not yet been made, are subject to the relevant transitional measures which apply in the individual Member States. In Austria it is allowed to place such biocidal products on the market, as long as all duties according to Art. 45 CLP are fulfilled for dangerous mixtures (note: until December 31st, 2020, a Safety Data Sheet has to be provided; from January 1st, 2021, the products have to be notified to ECHA by PCN portal according to Annex VIII to CLP) . In any case, Art. 95 BPR, stating that only active substances produced by a source listed in the Art.-95-list can be used, is obligatory. Moreover, all relevant indications in Art. 69 BPR must be fulfilled – e.g. indicating the active substance and its concentration on the product label, directions for use including the needed dosage etc.
Note: as biocidal products are also substances or mixtures, it goes without saying that the provision specified in REACH and CLP regulations also apply.
In the case of biocidal products containing more than one existing active substance, applications for product authorisations have to be submitted no later than the date of approval of the last active substance for that product-type (Art. 89 paragraph 3). After the active substance has been approved, the national transition measures for products containing existing active substances may be applied for no more than another three years. Where no application for authorisation has been submitted, the biocidal product can a) no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and b) use of the biocidal product may continue for up to 365 days. Where an application for authorisation of a biocidal product is rejected, or it is decided that no authorisation will be granted, or certain conditions are imposed for the authorisation, the following time periods apply for “existing” active substances: a) 180 days for making the product available on the market and b) 365 days for the use of the biocidal product after the date of the decision of the authority. (Art. 89 of the BPR)
A description of the authorisation procedures can be found under the menu item “Product assessment”.
Labelling of and advertisement for biocidal products
Substances and mixtures that are brought onto the European market must be classified, labelled and packaged according to the provision of the CLP Regulation. Moreover, Art. 69 BPR applies to biocidal products. This article states additional rules concerning labelling and packaging of biocidal products. Most importantly, it has to be made sure that biocidal products cannot be mistaken for foodstuffs and that they are unattractive to children.
Advertisement for biocidal products is regulated in Art. 72 BPR. The use of downplaying or misleading terms such as “environmentally friendly”, “organic” (or similar words and expressions) is not allowed.
„Poison Centre Notification“ (PCN) for the fulfillment of Art. 45 CLP
From January 1st, 2021, new products brought on the market for professional and consumer use (products, for which no SDS has been transmitted to the Umweltbundesamt GmbH or to the Austrian Poison Control Centre) have to fulfill the requirements of Annex VIII to CLP. This concerns the generation of UFI codes, the display of UFI codes on products as well as the notification of all products and UFI codes by the ECHA submission portal. As soon as the submitted information was successfully received (submission status: succeeded) Art. 45 CLP can be regarded as fulfilled.
Further information on the generation of UFI codes and Poison Centre Notifications can be found on the website of ECHA