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Regulation

Paraquat, like other active ingredients, is constantly being studied by national and global authorities and other researchers.

Recent Regulatory Decisions

In recent years, paraquat has been approved for re-registration following rigorous evaluation by several regulatory authorities. Paraquat has also received periodic re-evaluations of both toxicology and dietary residues by the WHO and FAO, respectively. A new FAO specification for paraquat was established in 2008 under the revised process for FAO and WHO specifications for pesticides.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) have recently (October 2016) concluded and published a comprehensive review of the toxicology of paraquat under the Chemical Review Program:

After consideration of the toxicological data submitted for the purpose of this review, the ongoing approval of this active constituent is supported. This review confirmed the existing health standards.”

Examples of recent re-registration decisions are from Colombia and Guatemala (2012), Thailand (2011), New Zealand (full re-registration 2007) and Canada (2014).

On 11th July 2007 the Court of First Instance of the European Community (CFI) (now the EU General Court) issued a judgment annulling Commission Directive (2003/112/EC of 1st December 2003) which included paraquat in Annex I to Council Directive 91/414/EEC.

The CFI decision to annul the Annex I inclusion of paraquat criticised the way in which the re-registration procedure was handled and the manner in which the Commission interpreted the relevant laws and applied them to its analysis of the data. The CFI was not empowered to decide itself on the safety of the substance.

The CFI decision is not in itself a ban on paraquat, but as a result of both the decision and the expiry of measures permitting individual Member State authorisations to remain in force during the previous review of paraquat for inclusion in Annex I, the Member States had to withdraw or suspend their national authorisations.

 

The major manufacturer of paraquat, Syngenta, comments on the status of paraquat in the European Union...

This decision does not affect the ability of farmers outside of the EU to use paraquat on products that they export to the EU. The EU maximum residue levels for paraquat can be found on the official EU MRL database.

Some references

  • In August 1997, the US Environmental Protection Agency concluded The use of currently registered products containing paraquat dichloride in accordance with approved labeling will not pose unreasonable risks or adverse effects to humans or the environment. Therefore, all uses of these products are eligible for re-registration

A fact sheet and re-registration eligibility document are available here. Paraquat is currently subject to periodic re-registration review in the USA, this process is expected to complete by end 2018. 

  • In December 2003, the EU concluded It has appeared from the various examinations made that there are uses of plant protection products containing paraquat which may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, provided appropriate risk-mitigation measures and restrictions are applied.

This statement, and the references therein, means that the EU scientific review concluded that there are uses of paraquat, following good agricultural practice, which will not have any harmful effects on human or animal health or on groundwater, or have any unacceptable influence on the environment. This decision allowed for continued registration of paraquat products in EU countries. The decision was subject to compliance with various requirements, including a stewardship program for operator safety and a monitoring program for operator health and wildlife incidents.

The review report and regulatory decision are available here

  • In 2003, paraquat was reviewed under a periodic re-evaluation of toxicology under the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). Its toxicological properties were evaluated and the acceptable daily intake (ADI) of paraquat was established. This allows an assessment of consumer safety to be made.

The 2003 JMPR report is available here

  • In 2004, paraquat was reviewed under a periodic re-evaluation of dietary residues under the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), The Meeting concluded that the intake of residues of paraquat resulting from uses considered by the current JMPR was unlikely to present a public health concern.

The 2004 JMPR report is available here.

The Codex Maximum Residue Limits for paraquat can be found here.

In 2003, the FAO/WHO Joint Meeting on Pesticide Specifications (JMPS) decided to establish a revised specification for paraquat technical concentrate under the new FAO/WHO procedure. These specifications promote the manufacture, distribution and use of pesticides that meet specific quality requirements. The specifications provide an international point of reference against which products can be judged, either for regulatory purposes or in commercial trade, and thus help prevent the trading of inferior products.

In 2008, the FAO specification was amended for SL and SG formulations.

Syngenta is the only paraquat manufacturer who can claim that its paraquat material was reviewed by JMPS and complies with the FAO specification as Syngenta is the only manufacturer who has submitted a data package and specification (which have then been evaluated as acceptable) in accordance with the current JMPS procedures.

In line with their obligations under Article 6.2.4 of the FAO International Code of Conduct on the Distribution and Use of Pesticides (2002), any other paraquat manufacturer should, at the earliest opportunity, provide data packages and specifications to the JMPS under the current procedure, for assessment of equivalence.

Global Registration Status of Paraquat

Paraquat is registered and sold in many countries around the world, including major agricultural markets with some of the most demanding regulatory systems, including: USA, Australia, Japan and New Zealand.