Low-risk active substances and basic substances
Regulation No. (EC) 1107 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.
Active substances approved as low risk are included in the GB Approval Register.
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 (EC) 1107/2009. Applications for basic substances must be submitted to HSE as the GB Competent Authority.
Basic substances are again included in the GB approval Register. 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.