Instructions for Submission
Application forms and templates
When submitting an application containing a candidate for substitution (CfS), the applicant must provide additional information for the comparative assessment. The application for the product containing a CfS should include the application form Comparative assessment, where as the information to support the comparative assessment shall be part of the national addendum.
If the applicant believes that indicated alternatives are has significant practical and / or economic disadvantages or brings a risk for resistance management or adverse effects for minor uses, then it is their responsibility to present arguments to support this position.
An existing application can be an irreplaceable part of an integrated pest management system (eg a certified IPM system). That may be a reason not to replace the application. When a product is replaced by an alternative out of the same resistance group, the number of groups of resistance does not decrease. This product eligible for replacement is not essential for resistance management The number of available resistance groups is not relevant in that case, and can be therefore be less than five.
To prevent the evolution of resistant pests, diseases or plants, a broad range of available products is important. At least five resistance groups must remain available. A resistance group is a group of products with a comparable effect. A suitable non-chemical method that can be used for resistance management counts as resistance group.
List non-chemical alternatives
One of the questions of the application focuses on the name of any non-chemical alternatives. In support of completing the form, this list Non-chemical alternatives of the Department for Environment, Food and Rural Affairs (DEFRA) of the United Kingdom is made available. This is partly based on Dutch research.
Practical or economical disadvantages and minor uses
Additional information on the assessment of practical or economical disadvantages as part of the process of Comparative Assessment has been presented in a note; which was certified by the Board for the Authorisation of Plant Protection Products and Biocides on May 25th of 2016.
See also our information about the toxicology, environmental and residues aspects of the risk assessment.
- Submission of the application for authorisation of a PPP containing a CfS
- agreement about simultaneous start of CA and regular assessment
- invoice for a supplemental deposit for CA
- communication about outcome of CA – step 1 (by e-mail)
- decision on main application together with CA
Check for completeness application
Principally the information for the comparative assessment has to be provided together with the submission of the regular application. It is the applicant’s responsibility to present arguments to support his position, indicating that alternatives have significant practical and / or economic disadvantages or bring a risk for resistance management or adverse effects for minor uses.
When the application concerns an amendment of an authorization, only for new uses information for the comparative assessment has to be supplied.
Derogation art 50.3: postponement of CA
When an applicant wishes to use the possibility of delay of the comparative assessment according to Art 50.3 of the regulation, it is required to submit an explanation why this experience in practice is necessary. Basically, when a product is already used for a considerable time in the EU and especially in the same climatic zone, this kind of experience is deemed to be unnecessary. The applicant has to submit an (updated) comparative assessment form one year before the expiry date of the product, as stated in the decision for authorisation.
The following must be submitted as part of a request for a postponed CA:
- cover letter with reference to original application and authorisation number
- CA form
A report of the experience of the new product is not required.
In general, the expiration date of a product is the expiration date of the active substance + one year. However, the expiration date of a substance is sometimes extended. If this new expiry date is after the postponed date of the comparative assessment, then the latter date becomes the expiry date for the product authorization. During a procedural extension for the expiry date, a postponement of a comparative assessment will be taken into account.