Chemical name: Phosphorothioic acid, O,O-diethyl O-(3,5,6-trichloro-2-pyridinyl) ester

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 chlorpyrifos because chlorpyrifos is not approved as an active substance under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.

EU Member States had to withdraw all authorisations for plant protection products containing chlorpyrifos as active substance by 16 February 2020 at the latest. Disposal, storage, placing on the market and use of existing stocks of plant protection products containing chlorpyrifos is prohibited as of 16 April 2020.

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

Summary of known hazards and risks to human health:

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

~ The genotoxic potential of chlorpyrifos, which cannot be ruled out based on the information available - positive findings were found in an in vitro chromosome aberration study and two in vitro unscheduled DNA synthesis assays; in vivo positive findings were found in open literature on chromosome aberration and on DNA damage caused through oxidative stress or by topoisomerase II inhibition which is considered a molecular initiating event for infant leukaemia. Consequently, health-based reference values cannot be established for chlorpyrifos and the dietary and non-dietary risk assessments cannot be conducted.

·Developmental neurotoxicity (DNT) - effects were observed in the available study on developmental neurotoxicity in rats (adverse effects were seen at the lowest dose tested in rats and a no observed adverse effects level 'NOAEL' could not be established) and epidemiological evidence exists showing an association between exposure to chlorpyrifos and/or chlorpyrifos-methyl during development and adverse neurodevelopmental outcomes in children.

Based on the evidence for DNT, experts during the peer review suggested that a classification of chlorpyrifos as toxic for reproduction, category 1B, H360D 'May damage the unborn child', in accordance with the criteria set out in Commission Regulation (EC) No 1272/2008 would be appropriate.

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 chlorpyrifos.

Summary of known hazards and risks to the environment:

As regards the environmental risk assessment it should be noted that, based on the human health risk assessment, it has not been established, with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The environmental risk assessment, although not finalised, cannot alter this conclusion since the approval criteria related to the effects on human health are not satisfied and should therefore not delay further the decision- making on the renewal of the approval of the active substance.

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

Not relevant

Date of entry into force of the final regulatory action: 10/01/2020

Complete entry into force of all provisions of Commission Implementing Regulation (EU) 2020/18 of 10 January 2020 concerning the non-renewal of the approval of the active substance chlorpyrifos was on 16 January 2020.