(2004/C 65 E/281)

WRITTEN QUESTION P-3093/03

by Harald Ettl (PSE) to the Commission

(14 October 2003)

Subject:   Inclusion of the active substance paraquat on the positive list in Directive 91/414/EC

At the meeting of the Standing Committee on the Food Chain and Animal Health on 2 and 3 October 2003, a decision was taken to include the herbicide paraquat on the positive list (Annex I) set out in Directive 91/414/EC (1) concerning the placing of plant protection products on the market.

Paraquat is extremely toxic for human beings and animals. It is also persistent and accumulates in the soil with repeated use. In view of its toxicity, there is a general ban on the use of paraquat in seven countries, and in other countries its use is strictly limited.

Despite the dangers which paraquat poses for human health and the environment, the Commission has proposed including the herbicide on the positive list, allowing it to be placed on the market in the EU and other countries. Relaxing the current restrictions on paraquat would frustrate efforts to achieve higher health and safety standards in agriculture, encouraging instead agricultural production methods that are unsustainable from a social and environmental point of view.

It is of particular importance to the European Parliament and citizens to learn what has made the Commission and the Council expose the people of Europe to this toxic and dangerous herbicide.

Answer given by Mr Byrne on behalf of the Commission

(12 November 2003)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market creates a harmonised framework for the authorisation and placing on the market of plant protection products. Active substances to be used as plant protection products are assessed and authorised at Community level and are listed in Annex I to the Directive. Subsequently, individual plant protection products containing active substances are assessed and authorised by Member States under harmonised rules.

Article 5 of the Directive provides for a listing of active substances in Annex I to the Directive when, in the light of the current scientific and technical knowledge, it is demonstrated that they satisfy, in principle, its safety requirements for human health and the environment.

For paraquat the data submitted by industry were evaluated by the Member States and the Commission within the framework of the Standing Committee on the Food Chain and Animal Health. The documents and information were also submitted to the independent Scientific Committee for Plants with a request to comment on the relevance of the possible risks for consumers and operators and on potential risks for the environment (in particular soil organisms, birds and hares).

In its opinion (2), the Scientific Committee concluded that when paraquat is used as a plant protection product as recommended under prescribed good working practices, its use does not pose any significant health risk for operators. It also noted that uses at recommended field rates are unlikely to pose a significant risk to soil-dwelling organisms. However, it requested a more detailed appraisal of the likely effects of paraquat on the rate of degradation of organic material in soil. This information was subsequently delivered and evaluated by the Rapporteur Member State and considered to be acceptable. It also concluded that available studies indicated a hazard to ground-breeding birds but that further information on realistic exposures would be needed for a definitive assessment of the risk. This information was also subsequently provided and the evaluation within the Standing Committee on the Food Chain and Animal Health concluded that, even though there are scenarios where exposure may occur, there are several situations where exposure to ground nesting birds is negligible. In this case the evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable, provided appropriate risk mitigation measures are applied. Finally, the Scientific Committee concluded that paraquat may be expected to cause lethal and sublethal effects for hares, but that the available data are inadequate to estimate the proportion of hares affected. The views of the Scientific Committee were taken into consideration when drafting the inclusion Directive and the Review Report.

Overall, the evaluation within the Standing Committee on the Food Chain and Animal Health concluded that the risk would be acceptable if appropriate risk mitigation measures are applied and that therefore the requirements of Article 5 of the Directive were met and that paraquat should be included in Annex I to the Directive.

Nonetheless, decision-making for paraquat was difficult because of its recognised toxicity. Therefore, the draft considered by the Member States in the Committee includes restrictive provisions as well as a mandatory monitoring and reporting programme and a proposed review of the efficacy of the risk mitigation measures.

The discussions also addressed the frequent use of paraquat in suicide attempts and in accidents in developing countries. However, the draft inclusion Directive would only be applicable in the Community. It contains technical specifications to minimise the possibility of accidental or even deliberate ingestion. To address these concerns the notifier has undertaken to use the Community's specifications for its global sales and to organise a stewardship programme worldwide. This programme will involve training in safe use, a monitoring programme of possible accidents and the development of formulations which are safer for the user.

The Commission is of the opinion that the risks connected with the use of paraquat can be managed in such way that its use is acceptable. Moreover, it is also to be expected that the risks connected with the use of plant protection products containing paraquat will be reduced on a world-wide scale.

It is also important to stress that inclusion in Annex I is not an encouragement to use paraquat and that the inclusion would not relax existing restrictions in the Community. It simply means that Member States may authorise the use of products containing paraquat. In fact, compared to the present situation, inclusion will most likely increase the protection of workers and the environment because of the extra restrictions (above and beyond those already in place) that will be obligatory on those Member States that decide to continue authorising products containing paraquat.

Moreover, after five years the Commission shall submit to the Standing Committee on the Food Chain and Animal Health a report on the application of the Directive on paraquat indicating whether the requirements for Annex I inclusion continue to be satisfied and may propose any amendment to it, including if necessary the withdrawal of paraquat from Annex I.

(1)  OJ L 230, 19.8.1991, p. 1.

(2)  Opinion of the Scientific Committee on Plants on specific questions from the Commission regarding the evaluation of paraquat in the context of Council Directive 91/414/EEC; SCP/PARAQ/002 adopted on 20 December 2001.