The current European Union directives on authorisation of pesticides (Directive 91/414/EEC for plant protection products and Directive 98/8/EC for biocides) are totally inadequate to prevent serious threats to the health of European citizens and our environment. This briefing explains our concerns and outlines what needs to be done to improve this alarming situation.

TESTING FOR HARMFUL PROPERTIES IS INADEQUATE

Pesticide toxicity is not properly assessed. Although pesticides are one of the most rigorously tested sets of chemicals, there are numerous important gaps in the kinds of tests required, especially for harmful properties which may not produce immediate, visible effects, or can affect vulnerable groups. PAN Europe has identified the following deficiencies in the current requirements for pesticide toxicity evaluation.

Insufficient testing for toxic properties which may cause damage years later
No systematic tests are required to identify pesticides which can disrupt our hormonal (endocrine) system which rules the body’s chemical messengers, (these are known as endocrine disrupting chemicals or EDCs), or those which can affect our immune system, which helps to protect us against disease. Neurotoxic properties are not systematically evaluated except for pesticides of groups known for their activity against acetylcholinesterase (organophosphate and carbamate pesticides damage this critical enzyme for nerve function). Possible consequences are lasting damage to the nervous system, brain development and behaviour, even if they might not produce noticeable, acute symptoms in the short term.

No review of the scientific literature is required
The results of tests required from industry are examined and most of the existing scientific literature is simply not considered.

New understanding about toxic effects is not taken fully into account
Research in the last decade has radically changed the way many toxicologists think about the harmful properties of chemicals[1]. The traditional view that “the dose makes the poison” has been shown to be a very poor framework for studying more subtle effects on human organs and development. The effects of some substances have been shown to be higher at lower doses. In some cases, the effect can vary with the duration of exposure.

Impacts on vulnerable developing organisms are not properly assessed
The foetus, infants and children are of special concern as they can be especially susceptible to toxic substances. A report by the World Health Organisation and the European Environment Agency [2] highlighted how this is not adequately addressed, for example, when regulators establish limits on the amount of a specific pesticide which can be “safely” consumed each day of life. We need tests designed to evaluate the effects later in life of exposure in key periods of development. Possible adverse effects not presently examined include neurotoxic, endocrine and immune system disorders and cancer. Children have greater exposure to pesticides in their diet, on a relative body weight basis, and hand to mouth behaviour is an important exposure route. Young children spend more time crawling at ground level where pesticide residues in household air, dust, carpets and on even on toys may significantly increase their exposure.

Chemical cocktail effects are ignored
Current assessment considers the effects of each pesticide active ingredient on its own. Yet, humans are exposed to a cocktail of hundreds of different chemicals, and harmful effects can be greatly magnified when a specific chemical interacts with others. Researchers can use effects of chemicals on the growth of certain nerve structures as a way to predict likely toxicity in developing tissues. The herbicide glyphosate, for example, causes damage to these cell structures at concentrations up to 100,000 times lower when it is applied with the other ingredients in the formulated Roundup product, than when applied on its own[3[. Although combination effects are receiving more attention[4], it is still extremely difficult to assess how combinations of different pesticides and other chemicals, absorbed via inhalation, through the skin or ingestion in food or water, might react together in our bodies.

Formulated products are only subject to a very few tests
Other ingredients (called inert ingredients as they have no pesticidal activity), mixed with the active ingredient to make up the final pesticide product may also have acute or chronic effects on health. A recent study by the Danish Environment Ministry[5] raised concern that very little is known about these ingredients and of those that have been studied, serious effects have been documented on the nervous system, blood and kidney function. As mentioned above, active and inert ingredients might also show unexpected combination effects in the formulated product.

CURRENT RISK ASSESSMENT IS INADEQUATE AND NON-TRANSPARENT

Risk assessment of pesticides is the basis for authorization of each active ingredient considered individually. But current procedures give only a very imperfect approximation of the real risk. Risk assessment takes into account not only toxicity but also estimated patterns of exposure to a particular pesticide, relying on data from healthy adult organisms. However, it also lacks sufficient testing for certain toxic properties, proper review of the scientific literature or consideration of new scientific findings, as discussed above. Some of these findings show higher impacts from pesticides than previously expected. Exposure assessment is very weak as pesticide usage data is patchy, multiple exposure routes are not considered and biomonitoring data (measures of concentrations in blood, urine, etc.) are lacking.

Risk assessment is carried out largely behind closed doors. It relies heavily on specified test data and other information, which an agrochemical company is obliged to pay for and provide when applying for approval for its pesticide active ingredient or product. The public does not have access to the human toxicological studies submitted by industry nor to exposure estimations. We can usually only read the summary assessments produced by the regulatory authorities, often after the important decisions have been taken. The risk assessment business involves close co-operation between the regulators and the pesticide industry. In France, for instance, the Ministry of Agriculture operates pesticide evaluation jointly with the Union of Plant Protection Industries (UIPP) and the National Union of Agricultural Co-operatives and Agro-suppliers (UNCAA)[6].

HUNDREDS OF HAZARDOUS PESTICIDES ARE STILL APPROVED IN EUROPE

Compared with many other parts of the world, we certainly have fewer dangerous pesticides in common use these days, particularly since the withdrawal in 2003 of over 300 active ingredients. This situation is due to a series of phase-out measures and bans over the last 15 years and the fact that agrochemical companies did not push for re-registration of about 300 older products, sometimes on economic grounds and sometimes because they knew they would not pass the stricter test requirements introduced in the 1990s. However, we still have hundreds of dangerous pesticides widely used and released or still present in the European environment.

The table below lists the numbers of currently authorised pesticide active ingredients with specific hazards as classified by national or international official bodies, as well as the numbers now withdrawn. A full list, along with the relevant classifications and sources, can be found in the dossier in French produced by PAN Europe partners Inter-Environnement Wallonie (IEW) in Belgium and Movement for the Rights and Respect for Future Generations (MDRGF) in France, downloadable on their respective websites[7].

Suspected hazard category

• Carcinogenic ( C ) Withdrawn: 48 Still in use: 92
• Mutagenic ( M ) Withdrawn: 5 Still in use: 2 (of which 1 also C)
• Reprotoxic ( R ) Withdrawn: 9 (of which 2 also EDCs) Still in use: 20 (of which 6 also EDC)
• Hormone disruptors ( EDCs ) Withdrawn: 36 (of which 19 also C) Still in use: 48 (of which 30 also C)
• Inducers of skin sensitisation Withdrawn: 8 Still in use: 25
• Neurotoxic (acetylcholinesterase inhibitors) Withdrawn: 67 Still in use: 47

Among the few “existing active ingredients ” (pesticides on the EU market before 1993) which have been reviewed according to pesticide authorisation Directive 91/414/EEC and added to the 'positive list' authorized at EU level (known as Annex I of the Directive) , some are classified as having properties of concern. They are skin sensitizers (bentazone, 2,4-D salts and esters, diquat (dibromide), thiram). Others are suspected endocrine disruptors (2,4-D, 2,4-DB, esfenvalerate, molinate, thiram) or suspected carcinogens (imazalil, iprodione, isoproturon, linuron, pendimethalin, propiconazole, propyzamide, thiabendazole, ziram) or neurotoxic and suspected reprotoxic (molinate).

Some other “existing active ingredients” were excluded from Annex I in 2003 but are nevertheless still allowed for certain uses until the end of 2007, as they are estimated to be of “essential use”. This decision was made despite their recognised properties of concern. Among them, chlorfenvinphos, cyanazine, flumetralin, promethryn, are suspected endocrine disruptors; acifluorofen sodium, cyanazine, fomesafen, oxadixyl, therbuthryn are suspected carcinogens; chlorfenvinphos, EPTC, ethion, flurathiocarb, heptenophos, omethoate, sulfotep, triazophos are neurotoxic inhibitors.

LEGISLATION MUST BE IMPROVED TO ENSURE A HIGH LEVEL OF HEALTH PROTECTION

The authorisation Directive 91/414 has to be reviewed in order to prevent health damage. PAN Europe and partners have been demanding specific changes in this Directive since 2000. Our position paper on EU Pesticides Authorisation provides a more detailed discussion[8]. It is not only environmental NGOs and public health groups pushing for change. Many academics and physicians[9] have expressed similar demands, as have a majority of Members of the European Parliament. In May 2002, the European Parliament[10] adopted a Resolution calling for a complete revision of the authorisation Directive. This will take place in the near future and the European Commission is now finalising its proposals on what should be done, for discussion by the European Parliament and the Council of Ministers in 2005, before final adoption. NGOs and concerned citizens can take action now for changes which will make a real difference. Our key demands are for:

§ Exclusion criteria for active ingredients based on their intrinsic properties. Pesticides which are suspected C, M, R or EDCs must be banned, along with those which are neurotoxic or skin sensitizers or persistent or bioaccumulative. The same should apply to those on priority lists of other EU legislations and/or international Conventions ratified by the EU.
§ The application of the substitution principle to encourage approval of least toxic products and alternative pest control methods.
§ The need for additional test protocols to identify endocrine disrupting, immunotoxic, neurotoxic properties, developmental toxicities and combination effects.
§ Requirement for an extensive review of the already existing scientific literature.

Transparency and public participation in the pesticides authorisation process is a final but no less essential demand. Our position paper on this subject[11] describes the issues and a full discussion is in our 2003 report[12]. The secrecy which surrounds the authorisation dossiers in the name of commercial confidentiality poses a major obstacle to civil society involvement in the decision-making and consultation process. Without access to all relevant documents in their complete versions, we cannot exercise our right to know on issues of environment and health impacts, nor make the most effective challenges to decisions which put our health at risk.

WE URGENTLY NEED A POLICY TO REDUCE PESTICIDE USE

Considering all the uncertainties about risk evaluation described above, as well as sufficient toxicological and epidemiological evidence of pesticides impacts and in order to avoid repeating the errors of the past[13], the precautionary principle has to be applied. Reducing human exposure to all pesticides is urgently needed in order to reduce health risks from pesticide use. The “chemical hygiene” concept advocated by an increasing number of medics aims to reduce exposure problems by eliminating use of hazardous substances in the first place. This concept has now to be applied by achieving a significant reduction in pesticide use. The Commission is currently developing a framework Thematic Strategy on pesticide use. In this context, PAN Europe demands specific legislation to reduce dependency on pesticides in Europe under our campaign for Pesticide Use Reduction in Europe (PURE)[14].

WHAT YOU CAN DO

Join our PURE Campaign
Information on our campaign for Pesticide Use Reduction in Europe (PURE) can be found in Briefing no. 1 and other documents on our website under PURE Campaign. We urge all interested civil society organisations to join the 90+ European organisations already signed up as PURE supporters.

Sign the Paris Appeal
The International Declaration on Diseases due to Chemical Pollution invites organisations and individuals to sign up via the ARTAC website http://appel.artac.info/anglais.htm

Find out more about pesticide problems
PAN North America’s excellent on-line hazards database at www.pesticideinfo.org is searchable by trade name as well as active ingredient. PAN Europe’s free newsletter gives regular information and links to new information from Europe. Sign up to become a subscriber via our website.

References
1. From Silent Spring to Scientific Revolution, part 1 and 2, J.P. Meyers. Rachel’s Environment and Health News n° 757, November 28, 2002 and n° 758 , December 12, 2002 , http://www.rachel.org
2. Children Health and Environment: A Review of Evidence, WHO Regional Office for Europe and European Environment Agency. http://reports.eea.eu.int/environmental_issue_report_2002_29/en/eip_29.pdf
3. Interactions between pesticides and components of pesticide formulations in an in vitro neurotoxicity test. J Axelrad, CV Howard & WG McLean, J. Toxicology 173 (30 259-268, 2002
4. Toxic effects of chemical mixtures, H. I. Zeliger , Archives of Environmental Health, Jan, 2003, http://www.findarticles.com/cf_dls/m0907/1_58/101860467/print.jhtml
5. Report on the health effects of selected pesticide co-formulants. Pesticide Research series no. 80, Danish Environmental Protection Agency, 2003. www.mst.dk
6. Dangerosité des matières actives et des spécialités commerciales phytosanitaires autorisées dans l’Union européenne et en France. C. Wattiez et F. Veillerette, , MDRGF et IEW, mai 2004, http://www.mdrgf.org et http://www.pesticide.be
7. Op. cit. 6
8. Position paper on EU Pesticides Authorization, April 2004. http://www.pan-europe.info/publications/index.htm
9. Paris Appeal : see http://www.artac.info
10. European Parliament resolution on the Commission report entitled: "Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market)' (COM(2001) 444 – C5-0011/2002 – 2002/2015(COS)). Paul Lannoye Rapporteur, adopted 30 May 2002. http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//TEXT+TA+P5-TA-2002 0276+0+DOC+XML+V0//EN&LEVEL=3&NAV=X
11. Position Paper on Transparency & Participation in Pesticides Authorisation, January 2004. http://www.pan-europe.info/publications/index.htm
12. How to organise public participation in the pesticides evaluation process? PAN Europe, London, 2003.
13. European Environment Agency, 2001, Late lessons from early warnings. The precautionary principle 1896-2000, Environmental issue report n°22, http://www.eea.eu.int
14. Information on our campaign for Pesticide Use Reduction in Europe (PURE) can be found on our website at http://www.pan-europe.info/PURE/pure_campaign.htm

This briefing was compiled by Catherine Wattiez, François Veillerette and Stephanie Williamson.