Chemical name: beta-cyfluthrin

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

Not relevant

Use or uses that remain allowed:

Not relevant

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 beta-cyfluthrin because beta-cyfluthrin is not approved as an active substance under 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 .

EU Member States had to withdraw all authorisations for plant protection products containing beta-cyfluthrin as active substance by 20 January 2021 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing beta-cyfluthrin are prohibited as of 20 July 2021.

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

Summary of known hazards and risks to human health:

In conclusion from the assessments made on the basis of the available information, no plant protection product containing the active substance beta-cyfluthrin 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 (EU) 546/2011.

The overall conclusion of the evaluation, based on the information available and the proposed conditions of use, is that the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009 are not satisfied as concerns related to human health were identified with regards to:

In case of the seed treatment, a high risk for workers has been identified as exposure exceeds AOEL, even with gloves and coverall;

In case of potato and wheat field applications the review has concluded a high risk to residents and to workers when the EFSA model was used. In case of the models in place of the time of application, the model by Martin et al. (2008) does not show high risk but the CDR approach (UK model) indicates high risk to workers, residents and by-standers;

In case of tomato use in greenhouses (non-permanent and permanent) a high risk has been identified for operators and workers even with mitigation measures.

The information available is 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 consumer risk assessment could not be finalised as residue trials with wheat, sugar beet and potato compliant with critical GAP and/or supported by storage stability data are missing as well as stability data for muscle and fat and a rotational crop metabolism study;

The consumer risk assessment could not be finalised with regard to the unknown nature of residues that might be present in drinking water, consequent to water treatment following abstraction of surface water that might contain beta-cyfluthrin and its metabolites.

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 beta-cyfluthrin

Summary of known hazards and risks to the environment:

In conclusion from the assessments made on the basis of the available information, no plant protection product containing the active substance beta-cyfluthrin 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 (EU) 546/2011.

The overall conclusion of the evaluation, based on the information available and the proposed conditions of use, is that the information available indicates that the approval criteria as set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009 are not satisfied as concerns related to the environment were identified with regards to:

In case of potato and wheat field applications the review has concluded a high risk for non-target arthropods and aquatic organisms. During the discussions with Member States, risk mitigation measures were considered for aquatic organisms and non-target arthropods but no risk mitigation has been found to guarantee safe use for non-target arthropods in the fields;

There is a high risk for non-target arthropods for tomato use in non-permanent greenhouses.

The information available is 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 assessment for birds and mammals consuming germinating beet seedlings could not be finalised;

The exposure and risk assessments for aquatic organisms could not be finalised with regard to the representative use in tomato in non-permanent (semi-protected) greenhouse.

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 beta-cyfluthrin.

Date of entry into force of the final regulatory action: 20/07/2020