Chemical name: 1,3,5,7-Tetroxocane, 2,4,6,8-tetramethyl-

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Banned

Use or uses prohibited by the final regulatory action:

All uses of metaldehyde as a plant protection product.

The application for authorization of the plant protection product Gusto was for professional use in strawberry, potato, root vegetables, onion, tomato, lettuce, cabbage, beans and peas and for non-professional use in private gardens.

The final regulatory action was based on a risk or hazard evaluation: Yes

Summary of the final regulatory action:

After an evaluation, the Norwegian Food Safety Authority has decided to deny

the application for authorization of the plant protection product Gusto (containing

metaldehyde) according to the Regulation of July 26 2004 nr. 1138 on

pesticides.

The reason for this decision was the unacceptable risks to birds and mammals.

The reasons for the final regulatory action were relevant to: Environment

Summary of known hazards and risks to the environment:

According to the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance metaldehyde (EFSA, 2010), a high acute and long-term risk was assessed for birds and mammals. Data gaps were identified for all representative uses to provide new acute and long term risk assessments for birds from all routes of exposure and a new acute and long-term risk assessment for granivorous mammals.

In the national evaluation conducted by the Norwegian Food Safety Authority on the plant protection product Gusto (with metaldehyde as active substance), the risk assessment concluded with high risk to birds. The estimated acute Toxicity Exposure Ratios (TER_A) and long term Toxicity Exposure Ratios (T ER_LT) indicate an acute and long term risk for birds ingesting granules as source of food, as grit or when seeking seeds as food. The proposed refinements are not acceptable as they do not cover smaller bird species, and assume a lower food intake than expected. For mammals, the risk assessment also concludes with a high acute

and chronic risk from ingesting granules as source of food, TER_A and T ER_LT indicate an acute and long term risk, and the proposed refinements are not accepted.

Expected effect of the final regulatory action in relation to the environment:

Complete reduction of the risk to birds and mammals from exposure to metaldehyde.

Date of entry into force of the final regulatory action: 16/02/2016