Chemical name: (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2- nitroguanidine

Final regulatory action has been taken for the category: Pesticide

Final regulatory action: The chemical is Severely Restricted

Use or uses prohibited by the final regulatory action:

All uses of clothianidin as a plant protection product except uses in permanent greenhouses.

Not relevant

Use or uses that remain allowed:

Not relevant

Pesticide use or uses that remain allowed:

Regulation (EC) No 1107/2009 on the placing on the market of plant protection products:

Commission Implementing Regulation (EU) 2018/784 severely restricted the use of clothianidin as plant protection product by only allowing uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses. The resulting crop had to stay within a permanent greenhouse during its entire life cycle.

In the meantime, i.e. on 31 January 2019, the approval of clothianidin expired. [Note: All approvals of active substances used in plant protection products are time-limited in the European Union.]

Form for notification of final regulatory action to ban or severely restrict a chemical Page 5

Regulation (EU) No 528/2012 on the making available on the market and use of biocidal products:

Clothianidin is approved in the EU under Regulation (EU) No 528/2012 for its use as an active substance in biocidal products for product-type 18- Insecticides, acaricides and products to control other arthropods (pest control). The validity of that currently applicable approval for PT-18 ends on 30 September 2026, subject to any modification that may be adopted before that date.

Commission Implementing Regulation (EU) 2015/985 of 24 June 2015 approving clothianidin as an existing active substance for use in biocidal products for product-type 18

http://data.europa.eu/eli/reg_impl/2015/985/oj

Regulation (EU) No 528/2012 on the making available on the market and use of biocidal products:

Clothianidin is approved in the EU under Regulation (EU) No 528/2012 for its use as an active substance in biocidal products for product-type 18- Insecticides, acaricides and products to control other arthropods (pest control). The validity of that currently applicable approval for PT-18 ends on 30 September 2026, subject to any modification that may be adopted before that date.

Commission Implementing Regulation (EU) 2015/985 of 24 June 2015 approving clothianidin as an existing active substance for use in biocidal products for product-type 18

http://data.europa.eu/eli/reg_impl/2015/985/oj

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

Summary of the final regulatory action:

The final regulatory action, i.e. Commission Implementing Regulation (EU) 2018/784, severely restricting the use of clothianidin in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market stipulates the following: Only uses as insecticide, in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses, may be authorised. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

EU Member States were required, in accordance with Regulation (EC) No 1107/2009, where necessary to amend or withdraw existing authorisations for plant protection products containing clothianidin as active substance by 19 September 2018 at the latest.

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

Summary of known hazards and risks to human health:

Not relevant

Expected effect of the final regulatory action in relation to human health:

Not relevant

Summary of known hazards and risks to the environment:

The overall conclusion from the review is that a risk to bees cannot be excluded except by imposing further restrictions to the use of plant protection products containing clothianidin as laid down in Regulation (EU) No 485/2013.

It was concluded that only the following uses of plant protection products containing the active substance clothianidin may be authorised, as they are expected to satisfy in general the requirements laid down in Article 29(1) of Regulation (EC) No 1107/2009 and the uniform principles laid down in Regulation (EU) 546/2011:

Uses in permanent greenhouses or for the treatment of seeds intended to be used only in permanent greenhouses. The resulting crop must stay within a permanent greenhouse during its entire life cycle.

Furthermore, taking into account the risks for bees from treated seeds, the placing on the market and the use of seeds treated with plant protection products containing clothianidin should be subject to the same restrictions as the use of clothianidin.

During the peer review of the updated pesticide risk assessment for bees for the active substance clothianidin, which considered the uses as seed treatment and granules, the following risks to the environment were identified:

Risk to bees via systemic translocation in plants - residues in nectar and pollen:

The Tier-1 risk assessment indicated a high risk to honeybees and bumblebees for:

oall uses other than the granular use to forestry nurseries, the greenhouse use to maize and sweet maize and those crops which are harvested before flowering (treated crop scenario).

oall uses other than the granular use to forestry nurseries and the greenhouse use to maize and sweet maize (succeeding crop scenario and weed scenario).

The Tier-2 risk assessment indicated a high risk to honeybees and bumblebees for:

oseed treatment uses to maize, winter oilseed rape and spring oilseed rape (treated crop scenario).

oall uses other than the granular use to forestry nurseries, for which no sufficient data was available to perform the assessment (succeeding crop scenario).

A high risk for bumblebees was concluded using the tier-3 risk assessment for the seed treatment uses to winter and spring oilseed rape.

The Tier-3 risk assessment was not sufficient to demonstrate a low risk to:

ohoneybees from the seed treatment uses to winter oilseed rape, spring oilseed rape and maize (treated crop scenario).

obumblebees for the seed treatment uses to maize (treated crop scenario).

osolitary bees for the seed treatment uses to maize, winter oilseed rape and spring oilseed rape (treated crop scenario).

ohoneybees, bumblebees and solitary bees (succeeding crop scenario).

Risk to bees from contamination of adjacent vegetation via dust drift:

A high risk to honeybees and bumblebees was indicated for all uses other than the use as a seed treatment to sugar and fodder beet, the granular use to forestry nurseries and the greenhouse use to maize and sweet maize. The risk assessment for seed treatments uses assumed that a deflector was fitted to the sowing machinery.

For the use as a seed treatment to sugar beet, a low acute risk to adult bumblebees was indicated. For the high dose application, a low risk was only indicated when it was assumed that a deflector was fitted to the sowing machinery. However, for the chronic assessment only a screening assessment, using the honeybee toxicity value divided by 10, was performed. This assessment was not sufficient to exclude a high risk to bumblebees.

Risk to bees via consumption of contaminated water:

The Tier-2 risk assessment fluids indicated high risk to honeybees from exposure to contaminated guttation fluids for the use to maize.

Furthermore, neonicotinoid insecticides are persistent in the environment, particularly in soil. The mean/median DT50 values for clothianidin in soil are 156 days. Clothianidin fulfils the criteria for being a vP substance.

The following data gaps were identified during the risk assessment:

Risk to bees via systemic translocation in plants - residues in nectar and pollen:

No Tier-1 risk assessment could be performed for the granular uses deto forestry nurseries owing to insufficient details in the GAP (treated crop scenario, succeeding crop scenario and weed scenario).

Only a screening assessment, using the honeybee toxicity values divided by 10, could be performed for solitary bees as no toxicity data were available. The screening level assessment did not exclude a high risk for all uses other than the granular use to forestry nurseries, the greenhouse use to maize and sweet maize and those crops which are harvested before flowering (treated crop scenario, succeeding crop scenario).

Sufficient data were only available to calculate exposure assessment goals for the seed treatment uses to maize, winter oilseed rape and spring oilseed rape. As the exposure assessment goal is fundamental for the Tier-3 risk assessment, only these uses could be considered at Tier-3 (treated crop scenario).

Risk to bees from contamination of adjacent vegetation via dust drift:

No Tier-1 risk assessment could be performed for the granular uses to forestry nurseries owing to insufficient details in the GAP.

For the use as a seed treatment to sugar beet data were lacking to be able to perform even a screening risk assessment for bumblebee larvae.

No Tier-2 risk assessment could be performed as there were insufficient data to be able to refine the exposure estimates for all uses under consideration.

Although several higher tier effects studies were available, no Tier-3 risk assessment could be performed owing to the lack of an exposure assessment goal.

Risk via consumption of contaminated water:

The risk to honeybees consuming residues in surface water could not be assessed for the outdoor uses.

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

Reduction of risk for the environment from the use of plant protection products containing chlothianidin.

Date of entry into force of the final regulatory action: 29/05/2018

Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2018/784 of 29 May 2018 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance clothianidin was 19 June 2018.