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 (2017), 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...

Read more: Syngenta viewpoint on paraquat withdrawal in Europe

Friday, 27 February 2009

The main manufacturer of paraquat, Syngenta, comments on the status of paraquat in the EU:In December 2003, following a detailed review and the scientific recommendation of the relevant EU committees, the Commission adopted Directive 2003/112/EC, which included paraquat in Annex I (“EU registration of paraquat”, to be found here in all languages).In February 2004, however, Sweden initiated legal action before the European Court in Luxembourg requesting that the Court declare Directive 2003/112/EC null and void. Sweden was later supported in this legal action by Denmark, Finland and Austria. On 11 July 2007, the Court of First Instance of the European Communities (CFI) decided in favour of Sweden and its allies and annulled Directive 2003/112/EC (ie declared it null and void). The judgment became effective on 27 September 2007 after a short appeal period and led to an unprecedented legal situation.Neither the European Commission nor an EU member state appealed against the CFI judgment. Syngenta was not involved in the legal action taken by Sweden and was, therefore, unable to appeal.As the Directive that included paraquat in Annex I to Directive 91/414 was void, paraquat was no longer in Annex I. In addition, the transitional measures, put in place to enable the continued sale of products containing existing substances during their review according to 91/414/EEC (stage 1), which also covered paraquat, had expired on 31 December 2006. As a consequence, with paraquat not included in Annex I, EU Member States were no longer allowed to authorise the sale of paraquat products – therefore, they had to withdraw or suspend registrations.In conclusion, the CFI judgment can in no way be regarded as a decision banning the use of paraquat in the EU following a scientific assessment in accordance with the applicable Community rules. It merely annuls the Commission Directive authorising paraquat as a result of various defects in the Commission’s management of the review.Syngenta communicated in February 2009 that it would not pursue a re-submission for the registration of paraquat in the EU at this time. The decision was based on commercial rationale and in consideration of the uncertainty caused by the forthcoming revision of the EU Registration Directive 91/414/EEC.This decision regarding paraquat in EU in no way affects Syngenta’s commitment to maintain and support its registrations worldwide.Paraquat is an important tool in agriculture. Farmers benefit from using paraquat because of its unique qualities, which include fast contact action and rapid deactivation in the soil. Paraquat also helps combat soil erosion, by preserving weed roots which bind the soil. It is widely used inminimum tillage agriculture which is more favorable for the absorption of carbon dioxide than traditional cultivation.Paraquat improves peoples' lives in developing countries by enabling farmers and their families to escape the constant requirement for hand weeding, which is a burden for millions of people in subsistence farming and underdeveloped rural communities.Syngenta has comprehensive data that demonstrate the safety of paraquat for users, consumers and the environment. The company is committed to promoting the safe use of all its products, including paraquat, through extensive stewardship and training. In 2008, these programs reached more than 3.4 million farmers worldwide.

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.

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Recent Regulatory Decisions

Some references

Global Registration Status of Paraquat