WRITTEN QUESTION P-3093/03 by Harald Ettl (PSE) to the Commission. Inclusion of the active substance paraquat on the positive list in Directive 91/414/EC.
Date: 2003-10-14
Institutions: European Parliament, Provisional data
Subjects: environmental protection, herbicide, market approval, plant health legislation, public health, scientific committee (EU), scientific report, toxic substance

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Official Journal of the European Union

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13.3.2004

Cycling helmets must comply with European standard EN-1078. The two academics describe that standard
as too vague and as not being based on reliable scientific data, with the result that helmets fail to meet the
purpose for which they are designed.

Is the Commission aware of the study carried out by the two CUL professors?

Does it share their conclusion that European standard EN-1078 is too vague and not based on reliable
scientific data and, if not, what arguments can it put forward to counter that view?

Is the Commission prepared to release resources to fund scientific studies into the production of the safest,
most comfortable and cheapest cycling helmets possible, and if not, why not?

Answer given by Mr Liikanen on behalf of the Commission

(11 November 2003)

The standard EN 1078 was elaborated by the European Committee for Standardisation (CEN) which means
that a group of international experts had developed this product standard in the light of the technical state-
of-the-art and that the standard had been voted by the CEN signatories after due verification.

The Commission published the reference of this standard in accordance to Article 5.4 of Council Directive
89/686/EEC of 21 December 1989 on the approximation of the laws of the Members States relating to
personal protective equipment (1) (PPE). Thus the standard was accepted for supporting the implementation
of this Directive since it directly addressed the essential health and safety requirement of its Annex II.

So far no research results challenging the protective performance of the standard have been mentioned by
any of the Member States representatives which meet twice a year with the Commission in two different
groups,
the Expert Group ‘PPE’ and the Group of administrative co-operation related to market
surveillance: the Commission service responsible for the Directive mentioned above is not aware of the
study quoted by the Honourable Member.

The Commission would also like to emphasise its interest
to be informed about research finding
concluding that a product standard is not fully satisfying and thus potentially exposing the European
citizen to safety and health hazards.

The Commission will put this issue on the agenda of the forthcoming meeting of the Member State’s
market surveillance authorities scheduled for December 2003 in order to investigate about the European
dimension of the problem raised.

The Commission will also discuss the issue with CEN directly in order to explore the need for action. The
issue could be tackled within the routine revision of product standards organised by CEN. Alternatively, it
could be included in the Commission’s mandates to CEN, using the framework within which the
Commission funds substantially the European standardisation work.

(1) OJ L 399, 30.12.1989.

(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.

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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.

(1) OJ L 230, 19.8.1991, p. 1.

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 (1), 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
the risk. This
information on realistic exposures would be needed for a definitive assessment of
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.

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Official Journal of the European Union

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13.3.2004

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
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.

the Directive on paraquat

indicating whether

(1) 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.

(2004/C 65 E/282)

WRITTEN QUESTION P-3125/03

by Monica Frassoni (Verts/ALE) to the Commission

(17 October 2003)

Subject: Structural aid for Valencia

The Commission’s reply to my question E-2398/03 (1) on structural aid for Valencia and the diversion of
water from the Ebro, stated that on 26 March 1999 the Commission only had statistical data for GDP in
the Valencian Autonomous Community for 1994, 1995 and 1996. When Objective 1 regions were
selected, calculations on the basis of the data for those three years put Valencia below the 75 % threshold.
However, the Commission acknowledges that the data were subsequently revised, and Valencia moved
above the 75 % for the same three years. The issue is therefore more serious than what the Court of
Auditors describes in its Special Report No 7/2003. The Court says that if the most recent statistics (1996,
1997 and 1998) had been used, the Valencian Autonomous Community would not have been entitled to
Objective 1 subsidies from the Structural Funds for 2000-2006, since the GDP was above 75 % of the
Community average, while the Commission is now stating that a revision of those same years 1994, 1995
and 1996, showed Valencia already above the 75 %.

How can such a mistake have been made in calculating GDP for 1994, 1995 and 1996? Why, on
26 March 1999, were no data more recent than 1996 available?

Can the Commission verify whether the data were manipulated so as to place Valencia below the 75 %
limit on 26 March 1999?

(1) OJ C 58 E,6.3.2004, p. 164.