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European Union - Final Regulatory Action
Amitrole CAS number:
61-82-5
Date circular:
12/06/2019

Chemical name: 1H-1,2,4-Triazol-3-amine

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 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 amitrole.
Amitrole is not included in the list of approved active substances under Regulation (EC) No 1107/2009. As a consequence, amitrole is not approved for placing on the market pursuant to Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.
EU Member States had to withdraw ali authorisations for plant protection products containing amitrole by 30 September 2016. Any grace period granted by Member States for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing amitrole had to expire on 30 September 2017 at the latest.

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

Summary of known hazards and risks to human health:

It was concluded that no plant protection product containing the active substance amitrole is 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 (EC) 546/2011.
According to the evaluation related to human health the following concerns were identified:
- risk to operators, workers, bystanders and residents;
- high potential for groundwater exposure by the toxicologically relevant metabolite of amitrole
(1,2,4-triazole) above the parametric drinking water limit of 0.1 pg/L in situations represented by all 9 pertinent groundwater scenarios for crop uses.
The information available was insufficient to satisfy the requirements set out in Article 4(1 ) to (3) of Regulation (EC) No 1107/2009, in particular with regard to the risk to consumers. In more detail, the consumer risk assessment for the representative uses on crops, according to the residue definition for risk assessment established by the peer review was not finalised, and data gaps were identified for storage stability data in crops with high water content and sufficient residue trials for the representative crop uses.
Additionally, amitrole is classified in accordance with Regulation (EC) No 1272/2008 as toxic for reproduction category 2 and it has toxic effects on endocrine organs (thyroid). Therefore, amitrole should be considered to have endocrine disrupting properties pursuant to the interim
provisions of the fourth paragraph of point 3.6.5 of Annex II to Regulation (EU) No 1107/2009.
However, given that the identified risks referred to above preclude approval of amitrole, it was not appropriate to consider whether exposure to amitrole under realistic proposed conditions of use is negligible. Therefore, it could not be concluded whether amitrole meets the approval
criteria related to endocrine disrupting properties as outlined in the first paragraph of point 3.6.5 of Annex II to Regulation (EU) No 1107/2009.
Furthermore, during the peer review it was proposed that amitrole should be re-classified as toxic for reproduction category 1B.

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

Reduction of risk for human health from the use of plant protection products containing amitrole.

Summary of known hazards and risks to the environment:

It was concluded that no plant protection product containing the active substance amitrole is 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 (EC) 546/2011.
According to the evaluation related to environment the following concerns were identified:
- high potential for groundwater exposure by the toxicologically relevant metabolite of amitrole
(1,2,4-triazole) above the parametric drinking water limit of 0.1 pg/L in situations represented by all 9 pertinent groundwater scenarios for crop uses;
- risk to aquatic organisms for non-crop uses;
- high risk to soil non-target macro- and microorganisms from metabolite 1,2,4-triazole for all
representative uses.
The information available was insufficient to satisfy the requirements set out in Article 4(1) to (3)
of Regulation (EC) No 1107/2009, in particular with regard to:
- the risk to birds and mammals for all representative uses;
- the risk to aquatic organisms for crop 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 amitrole.

Date of entry into force of the final regulatory action: 01/06/2016