Applications for products containing an active substance that has been classified as Candidate for substitution will be subject to a comparative assessment.
The aim of “comparative assessment and substitution” is to reduce risks by gradually replacing products containing substances that are appointed as candidates for substitution, by methods and products with a lower risk in order to benefit the protection of human or animal health and the environment. A comparative assessment with the alternative shall be performed to demonstrate whether it can be used with similar effect on the target organism and without significant economic and practical disadvantages to the user or not.
The European Commission established a list of substances identified as “Candidates for Substitution” (CfS). The list identifies active substances that are approved under the regulation (PPPR 1107/2009) – meaning that they are safe . However, these substances have certain properties that indicate a relatively high risk for environment and human health. The criteria used to classify an active substance as a candidate for substitution are defined in PPPR Annex II (4).
Alternatives can consist of other chemical products, but also of non-chemical agricultural practices. The Netherlands Food and Consumer Product Safety Authority (NVWA) advises the Ctgb on agricultural practices. If alternatives do exist, the corresponding use will no longer be authorised or renewed. Because the available products and agricultural practices can vary between countries, comparative assessment always takes place at the national level.
If the outcome of a comparative assessment is that an alternative product or method (substitute) is available for the product or one of its uses, then this substitution takes place after 3 years, unless the authorisation period of the corresponding substance expires before this.
Time line Comparative Assessment
The timeline for CA depends on the process of the “main” application. See timelines of the main application for an overview of the CA process for the concerning main application.