Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012. Garlic extract is one of the active substances listed in Regulation (EU) No 686/2012.
In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Ireland, and co‐rapporteur Member State (co‐RMS), Denmark, received an application from Ecospray Limited for the renewal of approval of the active substance garlic extract. In addition, the applicant submitted an application for inclusion of the substance in Annex IV of Regulation (EC) No 396/2005.
An initial evaluation of the dossier on garlic extract was provided by the RMS in the renewal assessment report (RAR) and subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The following conclusions are derived.
The uses of garlic extract according to the representative uses as a repellent, insecticide and nematicide on a wide range of crops in agriculture, horticulture, amenity, as proposed at European Union (EU) level result in a sufficient efficacy against the target organisms.
The assessment of the data package revealed no issues that need to be included as critical areas of concern with respect to the identity, physical, chemical and technical properties of garlic extract or the representative formulations. A data gap was identified for monitoring method in groundwater.
There are no critical areas of concern identified in the mammalian toxicology area.
With respect to the residues in food and feed, the use of garlic extract as plant protection product according to the good agricultural practice (GAP), even at the most conservative estimate of potential residues, it is not expected to pose an acute or chronic health risk to the consumer. Data have also been provided showing that intake of garlic extract by lamb and other ruminants such as cattle should not pose a health risk to these animals.
A maximum residue level (MRL) application for inclusion of garlic extract into Annex IV of Regulation (EC) No 396/2005 has also been submitted. The inclusion of garlic extract into Annex IV of Regulation (EC) No 396/2005 is supported.
In the area of the environmental fate and behaviour, no critical areas of concern were identified.
In the area of ecotoxicology, the risk assessment for aquatic organisms could not be finalised for all representative uses except for the granular product to be applied below the soil surface in potatoes and parsnips (in both field and greenhouses).