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Norway - Final Regulatory Action
Bitertanol CAS number:
Date circular:

Chemical name: 1H-1,2,4-Triazole-1-ethanol, .beta.-([1,1'-biphenyl]-4-yloxy)-.alpha.-(1,1-dimethylethyl)-

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 formulations and uses.

Pesticide use or uses that remain allowed:


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

Summary of the final regulatory action:

The Norwegian Food Safety Authority withdrew the authorization of the plant protection product Baymat Rosespray with the active substance bitertanol on the basis of EFSA's proposed classification of the substance as Repro.Cat.2, R61 'May cause harm to the unborn child'. The product was the only plant protection product with the active substance bitertanol on the market in Norway.

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

Summary of known hazards and risks to human health:

In the developmental toxicity studies, malformations were observed in rats and rabbits, leading to the proposed classification as Repro.Cat.2, R61 May cause harm to the unborn child.

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

Reduction of risk to human health.

Date of entry into force of the final regulatory action: 03/03/2012

March 3, 2012, after a 3 week appeal period after the publishing of the decision.