|Written by DPR Biocides - Anses|
IMPORTANT INFORMATION (update of 10.02.2017)
PT14 Major change: to submit before 28 February
DISCLAIMER: All change applications of the product (past and present) must be integrated into the application for TP14 renewal, including the reduction of the active substance concentration in order to conform to the 9th ATP.
For example, for products containing active substances at 50 ppm with general public use, for which you want a renewal for concentration below 30 ppm, a request to reduce the concentration of active substance must be submitted BEFORE 28 February 2017. Without submitted change application before the submission of the renewal, the request of renewal will be assessed for the current product. The general public use will be prohibited from placing on the market at the latest the 1st March 2018 in accordance with the 9th ATP.
PT14 : New measures (uploading 01/12/2016)
Application of the new classification regarding anticoagulant active substances in rodenticide products (PT14) modifies the conditions for classification of products containing these active substances. The product classification update must be made by 1st March 2018.
ANSES will implement the European Commission’s guidance document (Doc CA-May16-Doc.4.1 ), and the new classification is already being applied for all French marketing authorisation applications for products containing these active substances.
Concerned active substances:
The term biocidal products encompasses a group of products intended to destroy, deter or render harmless, prevent the action of or exert a controlling effect on any harmful organism, by means of chemical or biological action. Although they target harmful organisms, biocides are by definition active products liable to have effects on humans, animals or the environment (see also Article 3.1 a) of Regulation (EU) No 528/2012). Processes for the in situ generation of biocidal products are also governed by Regulation (EU) No 528/2012 (the BPR), as well as treated articles incorporating biocidal products.
These products are classified into four major groups, comprising 22 different product types:
Marketing authorisation (MA) application dossiers for biocidal products are examined in accordance with the provisions of the BPR. A helpdesk has been created to meet the needs of industrial companies wishing to submit such applications. ANSES has set up this free service to enable companies to find sufficient information on the various aspects of biocide regulations, to help them meet their regulatory obligations.
This helpdesk is aimed at any company that produces, imports, uses or markets a biocidal product: producers, formulators, importers, applicants/third-party applicants, current authorisation holders and downstream users.
The main aim of the helpdesk is to assist companies wishing to apply for MA for biocidal products, to comply with the regulatory requirements under Regulation (EU) No 528/2012. It also aims to provide easier access to the regulations, to information on the marketing of biocidal products, and to the procedures in force in France.
|Last Updated on Friday, 10 February 2017 15:57|