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The pesticides authorisation process has been harmonised at the European level through the Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market.

Ecological Council calls on the Commission to make use of the opportunity to propose a fundamental review of Directive 91/414/EEC, which should be based on the highest protection level available in existing EU legislation or international agreements, in line with the Precautionary Principle. The overall objective of Directive 91/414/EEC should be that avoiding negative impacts on or dangers to “health, groundwater and the environment and human and animal health should take priority over the objective of improving plant production.” Accordingly, EU agricultural policy should aim at sustainable agriculture, and the pesticide authorisation process should reconsider the degree of need for each individual pesticide.

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. 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with specific hazards as classified by national or international official bodies, as well as the numbers now withdrawn.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, and can be downloaded on http://www.pesticide.be

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  • Carcinogenic ( C ) Withdrawn: 48 Still in use: 92
  • Mutagenic ( M ) Withdrawn: 5 Still in use: 2 (of which 1 also C)
  • Reprotoxic ( R ) Withdrawn: 9 (of which 2 also EDCs) Still in use: 20 (of which 6 also EDC)
  • Hormone disruptors ( EDCs ) Withdrawn: 36 (of which 19 also C) Still in use: 48 (of which 30 also C)
  • Inducers of skin sensitisation Withdrawn: 8 Still in use: 25
  • Neurotoxic (acetylcholinesterase inhibitors) Withdrawn: 67 Still in use: 47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” which have been reviewed according to pesticide authorisation Directive 91/414/EEC and added to 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) and thiram). Others are suspected endocrine disruptors (2,4-D, 2,4-DB, esfenvalerate, molinate and thiram) or suspected carcinogens (imazalil, iprodione, isoproturon, linuron, pendimethalin, propiconazole, propyzamide, thiabendazole and ziram) or neurotoxic and suspected reprotoxic (molinate).

The Ecological Council does not believe that even carefully tested and assessed pesticides are safe. We want local, national and international agreements to reduce pesticide dependence and to phase out and ban the most hazardous pesticides. For the pesticides authorization process we suggest a two-step procedure: I. Exclusion of non-acceptable active ingredients based on hazard-criteria (cut-offs). II. Careful evaluation and control of other active ingredients not meeting these cut-offs.

I. Hazard-based cut-offs as criteria for non-authorization

Several important national and international chemical policy processes have acknowledged the understanding that chemical substances with certain intrinsic properties cannot be controlled and concluded that releases of such substances must come to an end.

For pesticides, stringent and consequent cut-offs need to be defined and used as a first step in the authorization process: active ingredients that meet these cut-offs must not be considered for authorization. Pesticides that meet criteria for toxicity, persistence or bioaccumulation, should not be considered for authorisations. Only pesticides which do not meet one or more of the above mentioned criteria can be further assessed for inclusion in Annex I.

Such an approach also renders the authorization process more cost-effective and less time-consuming.

Consequent inclusion of hazard-based criteria

Ecological Council supports the OSPAR approach that the direct or indirect releases of all substances with PTB properties to the environment must cease. OSPAR defined the following cut-off criteria to protect the marine environment from chemical substances . Ecological Council further acknowledges the Swedish chemical strategy to ban PB (P and B) substances .

Toxicity: Hazard-based criteria for human toxicity
Users of pesticides have to comply with protective measures, such as wearing protective clothing. The authorization of pesticides has to acknowledge that these measures will not always be implemented in practice during the application of pesticide products. Furthermore, consumers, including vulnerable groups, are exposed to pesticides through drinking water and food.

A special provision for substances which cause irreversible effects has already been laid down in the Biocides Directive, where biocides that are carcinogenic, mutagenic, toxic to reproduction, or sensitizing cannot be approved under Annex Ia (low-risk products). Comparable cut-off criteria also have to be included in the pesticides authorization, and have to be made more stringent: A pesticide which causes irreversible effects must not gain approval – even for use by trained users.

Ecological Council calls for the following cut-off criteria for human toxicity:
Pesticides (including their metabolites) shall not be authorized if they are under one of the following categories:

  • Carcinogenic
  • Mutagenic
  • Toxic to reproduction
  • Endocrine disrupting
  • Sensitizing

The terms above must include ‘suspected carcinogens / mutagens / toxic to reproduction‘ where scientific assessment acknowledges the possibility of such a potential but where absolute certainty is not known (precautionary principle must apply for these categories) (respective EU classes 1,2 or 3, or US EPA class A, B1, B2, C for carcinogens).

The production and use of pesticide active ingredients with these properties which are already authorised must be banned.

Persistence
The majority of the pesticide active ingredients are water-soluble and highly mobile. They can reach surface waters, groundwater, drinking water. The persistence criteria is thus the central criteria to assess environmental and (indirect) human health issues. In order to make sure that pesticides neither reach groundwater and drinking water nor persist in soil, they have to quickly degrade in the environment.

Pesticides currently have to be tested for their persistence in soil and in water (degradation of the active ingredient and relevant metabolites), and criteria for the non-inclusion of pesticides in Annex I have already been laid down in the uniform principles (DT 50 in soil > 3 months and DT 90 in soil > 1 year). Ecological Council generally welcomes the inclusion of cut-off criteria. Although, current authorisation practice has shown that these criteria have not been applied. Instead, additional results from (non-standardised) field tests have been used to override these criteria.

The persistence in water courses (surface water or ground water) does not present a criterion for non-authorisation at the moment. Further, there is no requirement to present data on the persistence under anaerobic conditions, and on the final degradation (mineralisation) of the active ingredient.

Ecological Council therefore calls for stringent cut-off criteria for persistence in the environment, based on standardised simulation tests:
A pesticide (including its metabolites) shall not be authorized if, under aerobic conditions,

  • the degradation time (DT50 for mineralisation) in soil is > 30-40 days,
  • the degradation time (DT50) for mineralisation) in surface water is > 20-30 days,
  • the degradation time (DT50 for mineralisation) in sediment system is > 120 days (for substances with a log Kow > 5)
  • Tests have also to prove degradation under anaerobic conditions (in soil and sediment/water systems).

Bioaccumulation
Generally, bioaccumulation of (bioaccumulative) substances can take place if these substances persist long enough in the environment to be taken up by organisms. The persistence criteria described above might not be sufficient to avoid bioaccumulation of pesticides with a high potential to bioaccumulate. The production and use of bioaccumulating pesticides is therefore unacceptable, even if these pesticides degrade quickly.

Ecological Council calls for a ban of the use and production of pesticides which are (or whose metabolites are) bioaccumulating with a BCF >= 500 or log Kow >= 4 (in line with the OSPAR B criteria).

II. Evaluation and control of other pesticide active ingredients

Even those pesticides that do not meet the cut-off criteria, and which are carefully assessed before authorisation along the lines described in the paper, may pose a considerable risk to human health and environment. The environmental and human health effects of pesticides cannot be fully predicted and occurrence of these pesticides in human tissues, food and the environment should be thoroughly monitored. These monitoring programmes must be financed by industry.

Ecological Council calls for
• a 10 year authorisation period, using this time to prioritise reviewing the most problematic pesticides
• monitoring of pesticides active ingredients to be financed by industry

Inclusion of the comparative assessment, with special attention to non-chemical alternatives
A comparative assessment offers the chance to identify the least harmful alternative for a certain pesticide use category. It also has the advantage of comparing the hazardous properties of a group of substances with the same mode of action.

The substitution principle has already been introduced to the Biocides Directive, although it only relates to a comparison of active ingredients. It has also been proposed and used by Northern European countries. The substitution principle must also be transferred to the pesticides approval process.

Ecological Council wants the comparative assessment to be introduced into the new pesticides Regulation along the following lines:
• An active ingredient must not be authorised if it can be substituted by non-chemical methods or active ingredients that are less harmful to human health or the environment.
• Economical or practical disadvantages are secondary to a higher protection of human health and the environment.
• A database containing non-chemical alternatives has to be set up at the European level, to assist this process

Mutual recognition
The authorisation of pesticides follows a two-step approach: after the evaluation and inclusion of an active ingredient in Annex I of the directive at European level, products containing this active ingredient have to be approved at Member State level, and these authorisations have to be accepted by other Member States unless the agricultural, environmental and climatic conditions are not comparable. (See also Zonal Registration below).

Many hazardous pesticides are included in Annex I for “safe” uses (e.g. Paraquat), and the inclusion in Annex I therefore give a wrong signal about “safety” to third world countries and the Member States.

Both pest, weed and disease incidence and pressure and the climate will varies widely in the climate zones and therefore and therefore local based evaluation of pesticides should always be done.

Ecological Council therefore calls for
• The right for a member state to ban use of pesticides on Annex 1 to protect environment and health and to promote pesticide use minimisation.

EU-decisions should not be able to undermine protective legislation set by individual member states, especially when there is no significant evidence that this higher level of protection has caused economic losses for farmers, or where concrete benefits for health, biodiversity, water quality etc have been gained.

Zonal registration of products
The Commission is currently proposing three zones (Scandinavia, Northern Europe and Southern Europe) for registration of pesticide products in the new pesticides Regulation. This has come about because the European Commission has recognised that mutual recognition at the member state level for the registration of pesticide products has not work as originally designed under Directive 91/414/EEC.

Ecological Council is concerned about zonal registration because it will counteract pesticide use minimisation. It will increase the number of pesticide products in all member states strongly. In each member state, more active ingredients and more products per active ingredient will be approved.

In 2004 83 active ingredients are approved in Denmark, 56 in Sweden and 203 in UK. If Denmark is included in the same zone as Sweden, the number of active ingredients in Denmark will increase to 106, if Denmark had to accept all the active ingredients approved in Sweden.

The Danish farmers are lobbying for getting in the northern Europe zone with UK, Germany etc. If Denmark is included in the same zone as UK, the number of active ingredients in Denmark will increase from 83 to 210, if Denmark had to accept all the active ingredients approved in UK.

Ecological Council supports further cooperation between member states in the approval process of products but the Member states should have the right not to approve products with reference to the substitution principle and the national pesticide use reduction plan.