This review was performed in connection with the European Food Safety Authority’s (EFSA) public consultation of the active substance clofentezine.

Spain and the Netherlands were the designated so-called rapporteur and co-rapporteur member states respectively. Spain prepared the draft assessment report. This assessment concerns the health and environmental risk posed by clofentezine, including but not limited to its physical/chemical properties, mammalian toxicity, residues in/on food and feed, environmental fate and behaviour, as well as ecotoxicity. This application is for the renewal of approval of the active substance for use in the Apollo 50 SC plant protection product.

The review was self-tasked, performed by the VKM panel on plant protection products, based on information provided by the applicant in the rapporteur draft assessment report (DAR), and relevant peer-reviewed scientific literature. VKM sent in their comments 20.12.2018, employing EFSA’s comments template.

The approval process for plant protection products

Norway is affiliated with the European Union's approval scheme for the use of plant protection products through the EEA agreement. Therefore, Norway adopted the EU regulations on pesticides in a new regulation for plant protection products in the summer of 2015. In the EU, active substances are evaluated through a phased approach:

• The applicant submits an application for approval of the active substance to a designated rapporteur Member State (RMS), together with a dossier.
• A designated “rapporteur” Member State (RMS) carries out an initial risk assessment and prepares a draft assessment report (DAR) for a new substance or a renewal assessment report (RAR) for an already approved active substance.
• EFSA reviews the DAR/RAR in cooperation with all Member States.
• EFSA drafts a conclusion on the active substance.
• The European Commission takes a legislative decision whether or not to include the substance in the Union’s list of approved active substances.

Active substances are generally approved for a period of 10 years. It is possible for an applicant to apply for renewal upon expiration.

Clofentezine

Clofentezine was introduced to the EU for use as an active substance in plant protection products in 2001. The existing approval was due to expire 31.12.2018. In accordance with existing regulations, the applicant therefore applied for renewal before the expiration date.

In Norway, clofentezine was approved in the Apollo 50 SC product for use from 1991 and was withdrawn by the importer in 2012.

Clofentezine, an acaricide, is an ovicidal mite growth inhibitor, which controls spider mites including the two-spotted spider mite, and European red mite. Clofentezine is used in a wide range of crops including fruits and vegetables such as pome fruits, citrus fruits, banana, strawberry, nectarine, raspberry, tomato, pepper, cucumber and squash, as well as ornamentals.