Current requirements for the authorization of preparations that are not classified as plant protection agents
Nébih draws the attention of license holders to the fact that the previous provision on the composition of preparations that are not classified as plant protection agents has been amended. From now on, preparations belonging to this range can also contain simple substances, but this requires an additional statement from the license holder.
From now on, simple substances can also be included in the composition of preparations that are not classified as plant protection agents. These include:
- products with a plant protection effect that do not qualify as plant protection agents,
• the coating aids,
• protective materials,
• interaction enhancers,
• auxiliary materials,
• effect modifiers and
• tools for plant protection.
If the preparation contains a simple substance (regardless of concentration), the license holder must declare in writing that the use of the product is not the same as that described in the review report for the given simple substance in the database according to the 540/2011/EU executive order. The signed and sealed declaration must be submitted together with the application. The declaration is also required in the case of ongoing procedures, i.e. license applications that have already been submitted but not yet adjudicated.
The preparations may still not contain active ingredients marked as “approved” and “not approved” in the database
That is why it is particularly important that, in the case of the preparations concerned, the license holders always check their composition during the compilation of the authorisation/re-authorisation documentation. It is also important information that the complete composition of the co-formulants must be submitted for the evaluation of the preparations. In the case of confidential information, the manufacturing company can also send the composition directly to the licensing authority. 89/2004. (V.15.) The review of the composition of already licensed preparations according to Annex No. 9 of FVM Decree takes place at the time of relicensing.
Nébih
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