New active substance approval
Active substances to be used for plant protection purposes have to be approved by the European commission, before they can be used to formulate plant protection products. In the European Union the criteria for this approval are laid down in a Regulation. This regulation also describes the cooperation of the EU-member states in the assessment process of the active substances.
Regulation (EC) No 1107/2009 lays down harmonised rules for the approval of active substances and the placing on the market of plant protection products.
The process for deciding whether a new active substance can be approved for use in plant protection products, in the European Union (EU), involves all Member States, the European Food Safety Authority (EFSA) and the European Commission. Members of the public and other interested parties can also provide comments for consideration in the process, specifically through the public consultation process of EFSA. Only approved active substances can be authorised in plant protection products in the EU. An active substance can only be approved if it meets the requirements and conditions specified in Regulation (EC) No 1107/2009.
After an active substance is approved, a national application for registration of a plant protection product containing the active substances can be submitted. Plant protection products have to be authorised on national level.
In certain approval regulations for active substances, a field of use is mentioned (insecticide , herbicide, fungicide, etc.). This field of use is restrictive. An application for product authorisation is not possible based on a substance with a field of use that is not matching the field of use of that product. The active substance approval has to be amended for the field of use first.
The process for an amendment to the conditions of an approval is identical to the process for approval of an active substance. (eg for extension of the field of use).
The process for the renewal of approval of an active substance is similar to the process of first approval of an active substance.