Low-risk active substances and basic substances
Regulation 1107/2009 introduced new categories of 'Low-risk' (Articles 22 and 47) and ''Basic substances' (Article 23). Below is a brief description of each and provides links to where further information can be found.
Low-risk active substances
Low-risk substances are active substances which have been evaluated as having a Low-risk. For the approval of these substances, the standard assessment procedure applies. The assessment process determines whether a substance has a low-risk profile. Consequently, there is no separate application or assessment procedure for low-risk substances. Neither is there a separate application procedure for products based on these active substances: A standard authorisation is still required for these products, however product authorisation is assessed more quickly. A major benefit for applicants is that the active substance will be approved for 15 years instead of the normal 10 years for first approval. As a result, the maximum authorisation period for products based on these substances will also be longer: Up to 15 years. In addition, longer data protection up to 15 years can be granted accordingly and there is provision on advertising of low-risk products.
The criteria applied to these Low-risk active substances and products are currently under EU consideration, in which the UK is actively participating. When agreement is reached a Guidance document which aims at specifying new criteria for the approval of low-risk active substances and which will also provide guidance for implementation of those criteria in the approval of active substances as "low-risk active substances" according to provisions laid down by Regulation (EC) No 1107/2009 on placing plant protection products on the market will be made available on the Europa Guidance website.
Active substances approved as Low-risk are included in the EU Pesticide Database on active substances. To find Low-risk substances, from the database homepage chose 'Advanced Search', then click on the drop down menu next to 'Type' and select 'Low-risk active substance', all approved Low-risk active substances will then be displayed. To view details of the active substance click on the '+' next to the active substance name.
A 'basic substance" can be described as "active substances, not predominantly used as plant protection products but which may be of value for plant protection and for which the economic interest of applying for approval may be limited".
Criteria for their approval are laid down and specific provisions are set to ensure that such active substances, as far as they do not have an immediate or delayed harmful effect on human and animal health nor an unacceptable effect on the environment, can be legally used in the EU after having been approved as "basic" under Regulation 1107/2009. Applications for basic substances must be submitted to the European Commission, and an authorisation is issued for the entire EU for an indefinite period.
Basic substances are again included in the EU Pesticide Database on active substances. A summary of the approved uses and conditions of approval, for a basic substance can be found in the Review Report which is available on the page showing the details of that substance. To find Basic substances, from the database homepage chose 'Advanced Search', then click on the drop down menu next to the 'Type' and select 'Basic substance' all approved, pending and non-approved basic substances active substances will then be displayed. To view details of the active substance click on the '+' next to the active substance name.