Chemical name: Benzenamine, 4-(1,1-dimethylethyl)-N-(1-methylpropyl)-2,6-dinitro-, N-sec-Butyl-4-tert-butyl-2,6-dinitroaniline

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 the applications as a plant protection product.

Pesticide use or uses that remain allowed:

Not relevant.

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

Summary of the final regulatory action:

It is prohibited to place on the market or use plant protection products containing butralin. Butralin is not included in the list of authorised active substances in Annex I to Directive 91/414/EEC. Authorisations for plant protection products containing butralin had to be withdrawn by 20 April 2009. From 29 October 2008 no authorisations for plant protection products containing butralin were allowed to be granted or renewed by the Member States and all uses of plant protection products containing butralin are prohibited as from 20 April 2010.

The reasons for the final regulatory action were relevant to: Human health and environment

Summary of known hazards and risks to human health:

Based on the available data, a high risk level was identified with regard to operator exposure. The risk assessment carried out indicated that 100% of the health-based limit value (AOEL- Acceptable Operator Exposure level) for the active substance butralin may be exceeded under practical conditions of use.

Risk reduction measures have been recommended to address the high risk level for the operator. The recommended protective measures are S36/S37: wear suitable protective clothing and gloves.

Based on the available data the Rapporteur Member-State proposed in the Draft Assessment Report to classify butralin as follows:

T - Toxic,

R40 - Limited evidence of a carcinogenic effect,

R61 - May cause harm to the unborn child.

The proposed classification for carcinogenic effects is based on the potential carcinogenic effect observed in rats but data were considered not sufficient to assess the relevance to humans.

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

Reduction of risk from the use of plant protection products.

Summary of known hazards and risks to the environment:

The draft assessment report underlines that butralin is highly toxic to aquatic organisms and may bio-accumulate. Based on the available data, unacceptable risks were identified during the risk evaluation with regard to the toxicity to aquatic organisms. The toxicity exposure ratio (TER) was below the trigger value for fish and invertebrates (both acute and chronic exposure), algae and aquatic plants. However, the rapporteur member state concluded that refined risk assessments for aquatic organisms based on additional data are necessary.

The following classification is proposed in the draft assessment report for Butralin:

N - Dangerous for the environment,

R52 - Harmful to aquatic organisms,

R53 - May cause long term adverse effects in the aquatic environment.

There were also concerns related to the substantial lack of data to assess the risk to aquatic organisms, in particular with regard to the metabolite DNTBA.

Butralin is highly toxic to mammal embryos and it was concluded that an off-field risk assessment to small herbivorous mammals should be conducted.

Laboratory studies also gave concern for the toxicity of butralin to some species of non target arthropods (Aphidius rhopalosiphi and Typhlodromus pyri). Since in-field levels of butralin may represent a risk to those non-target arthropods, further tests and a refined risk assessment were required.

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

Reduction of risk from the use of plant protection products.

Date of entry into force of the final regulatory action: 20/04/2010

Complete entry into force of all provisions of Commission Decision 2008/819/EC of 20 October 2008 is 20 April 2010 since all uses of plant products containing butralin were prohibited as from that date at the latest.