Home Biocidal products Assessment framework biocidal products Laws and Regulations Laws & Regulations on biocidal products Whether or not your application for authorisation of a biocidal product will be assessed according to the Biocidal Products Regulation or according to transitional legislation in the Netherlands depends on the active substances in the product. You can determine the correct assessment framework based on the decision tree. See also the status of the active substances. Active substances and current legislation All applications for authorisation of biocidal products based on an approved active substance (included on the Union list of Approved Active Substances) are processed by ECHA. Applications for authorisation of a biocidal product based on an active substance that is not approved (or is still under review) must be submitted under transitional legislation to the competent authority in the Member State concerned; for the Netherlands, this is the Ctgb. Included active substance Review programme for an active substance has been completed: – Inclusion in Annex I of Directive 98/8/EC (until 1 September 2013) – Inclusion on the Union list of Approved Active Substances of Regulation 528/2012 (as of 1 September 2013) The inclusion of active substances takes place according to product type. Substances in Annex I are placed automatically on the Union list. Product types In the European context, active substances are assessed according to safe use. According to the Biocidal Products Regulation, 22 product types are distinguished. This website identifies all the active substances that are being assessed in this European review programme and for which product type they are being assessed. Biocidal Products Regulation (EU) 528/2012 Since 1 September 2013, an application for authorisation of a biocidal product or renewal of an authorisation under Biocidal Products Regulation (EU) 528/2012 can be submitted through the information system provided by the European Chemicals Agency (ECHA). The application itself must be submitted via R4BP, but the dossier is created in IUCLID. ECHA is responsible for the development of these systems, and has prepared instructions for their use. All information is available on the website of ECHA. To obtain an authorisation or renewal of an authorisation for a biocidal product, you can choose from the following types of applications: National authorisation; Union authorisation; Simplified authorisation; Mutual recognition Transitional legislation in the Netherlands An authorisation under Transitional legislation in the Netherlands is based on the Plant Protection Products and Biocidal Products Act (Wgb) and is valid only in the Netherlands. If you also want to place your product on the market in other Member States, you must determine the regulations for authorisation in those Member States. For an application based on transitional legislation in the Netherlands, refer to the application forms on our website. Here you will also find the application forms for requesting an amendment to and/or extension of your authorisation (as long as it is subject to transitional legislation).