1Nitrates can be converted to nitrites, which can be acutely toxic to infants and can contribute to the formation of carcinogenic nitrosamines. It is not possible to set a margin.

Comparison of the risk from pesticides and other pollutants in foodstuffs

The table shows that pesticide residues in foodstuffs do not constitute as great a risk as do various heavy metals (lead, cadmium and mercury), PCB and residues of old - now banned - chlorinated pesticides (DDT and dieldrin). Rather, pesticides constitute a risk of about the level of the various mycotoxins. The toxic content of food plants is also considered to constitute a greater risk than pesticides. These toxins include, e.g., glycoalkaloids in potatoes and tomatoes, lectins in dried beans, cyanoglycosides in apricot kernels, bamboo shoots and linseed, and phenylhydrazines in mushrooms, and constitute a greater risk than the pesticide residues. Interest in these toxins is increasing, in part because their content in food plants can be inadvertently increased by gene splicing.

5.4.3 Natural substances

All plants contain poisonous substances to varying extents. Their job is to protect plants against attacks by viruses, micro-organisms and plant-eating animals, especially insects. Evolution has enabled different species of micro-organism and animal to specialise, so that they can live on plants that are poisonous to other organisms. Familiar examples of such poisonous plants are deadly nightshade, spring groundsel and cow parsnip. Man's nourishment consists of less than 100 plant species. Even though individual plants contain substances that are toxic to other groups of organism, they are in most cases only of very low toxicity to humans. Humans have carried out the deliberate selection of crops as being acceptable and edible and, through the forces of evolution, have developed enzyme systems that break down their component substances. Man also uses poisonous plants, such as coffee and tobacco. The special use of the tobacco plant gives a significant risk of developing cancer in humans. When "novel food" products (including products made from genetically-modified plants) are introduced, the authorities conduct a risk assessment comparable to a pesticide assessment, in order to protect consumers.

In contrast to man-made pesticides, natural pesticides are mainly contained within plants and are only released when other organisms approach a plant, touch it or feed on it. Such natural pesticides are normally spread over a larger or smaller area, with the purpose of neutralising pests in the entire area with an effectiveness of at least 90%. This exposes all organisms that come into contact with the toxin or that later feed on parts of plants containing natural pesticide residues in the area.

A Danish EPA publication, "Oversigt over godkendte bekæmpelsesmidler 1998" (an overview of approved pesticides, 1998) shows that a total of nine naturally-occurring active ingredients have been granted approval. In addition, two more are still in the application phase.

Apart from the element sulphur, these naturally-occurring substances degrade relatively easily, so that their effectiveness is of short duration. At the time of writing, they are only used on small areas where, as with synthetic active ingredients, the intent is to neutralise more than 90% of the pests. In principle, there is therefore no difference between these pesticides and synthetic pesticides, considered from the standpoint of their effects on the environment and health.

Natural active ingredients are characterised by their significantly lower toxicity to mammals and by their significantly faster degradation, in comparison to synthetic pesticides.

One of the most important groups of modern, synthetic pesticides is the so-called "pyrethroids", which contain the same active group as pyrethrum, but in which the molecule has been stabilised by inserting, e.g., benzene groups, chlorine atoms, bromine atoms or cyano-groups. This also increases their toxicity to insects considerably, for instance, by 1000 times for deltamethrin, in comparison to the natural pyrethrins. At the same time, the increased stability of the molecules entails the risk of spreading to the atmosphere, to surface water and to ground water. The example of the pyrethroids illustrates how the synthetic pesticides usually contain chemical structures, which are rarely encountered in nature and which increase their biological effect by modifying the physico-chemical properties of the molecule, to obtain lower degradability, higher persistence, changed solubility and increased properties for penetrating membranes.

5.4.4 Patterns of consumption in other countries

Consumption of active ingredients in Denmark and other countries

Patterns of pesticide consumption vary widely from country to country, and Fig. 5.1 shows the consumption of active ingredients per ha in different countries. This is used in other countries as an indirect measure of the impact on the environment. As can be seen from the figure, Denmark has the third lowest level.

The reason for this is a combination of the efforts of agriculture to reduce consumption, as well as differences in cultivation intensity, the crops cultivated, climate conditions and the significant variation in the pressures of disease and pests.

A survey from 1996 described the consumption (kg active ingredient) in four different countries and showed that the quantities used within the individual regions vary widely. Even though there are differences between regions, those differences are still smaller than the differences between farms in a given region. This is because of differences in the cultivation systems used, choice of variety, crop-rotation regimes, variations in the pressures of disease and pests, as well as the choice of product and dose. Only limited information is available on consumption patterns in different crops, which makes it difficult to generalise about pesticide use in crops cultivated in different regions.

Figure 5.1 Consumption of pesticides in other EU countries, 1996.

Captions, Figure 5.1
Belgien = Belgium
Frankrig = France
Italien = Italy
Grækenland = Greece
Tyskland = Germany
Østrig = Austria
Irland = Ireland
Spanien = Spain
Danmark = Denmark
Sverige = Sweden
kg a.s... = kg a.i./ha

5.5. Current Danish regulation of pesticides

5.5.1 Pesticide policy to date

One of the main goals of Danish environmental policy is to secure the health and welfare of the population. As far as pesticides are concerned, this effort is based on the Chemical Substances and Products Act and on the 1986 pesticides action plan. In addition, the EU Council Directive on quality of water intended for human consumption sets a 0.1 µg/l limit for pesticides in drinking water.

Chemical Substances and Products Act

The purpose of this act is to prevent the use of chemical substances from harming health and the environment and to promote the use of cleaner technology. The Act shall ensure illumination of the dangers of substances sold in this country and regulation of the sale and use of chemical substances and products, which are, or are assumed to be, dangerous to the health or harmful to the environment.

Pesticides action plan

The purpose of this 1986 action plan was "to reduce the consumption of pesticides, and thereby to:

• protect people against health risks and harmful effects resulting from the use of pesticides. This applies equally to the users of pesticides and to the population in general, which must be protected against the ingestion of pesticides through food and drinking water;
• protect the environment, i.e., harmless and useful organisms among the flora and fauna on arable land and in aquatic environments."

The goal of the action plan was

"that the total consumption of pesticides be reduced by at least 25% before 1 January 1990. Another 25% reduction is desired before 1 January 1997."

It was also mentioned that

"where the applied quantities and treatment frequencies are concerned, the consumption of products that possess particularly alarming health and environment-related properties shall be accounted separately, as sufficient information on the properties of these products becomes available."

The action plan also emphasised that "as it is peculiarly difficult to determine an environmentally acceptable level for the consumption of pesticides, it is necessary (to reduce the impact on the environment) to reduce as far as possible the consumption of pesticides. Our present agricultural production cannot, however, be sustained in the complete absence of pesticides which, as is common knowledge, are used particularly to protect against weeds, disease and pests, as well as for growth regulation."

Status of the action plan

By the end of the 10-year period, the action plan's goal of tightening the approval scheme had been attained. At that time, the Danish EPA had reassessed 213 active ingredients. Of these, 105 have now been banned, because a lack of documentation meant that no application was made for reassessment or because the applications were withdrawn by the applicants. 78 substances were granted approval, whereas 30 were banned or strictly regulated.

The general reduction in pesticide use was only partially attained, as the quantities of active ingredients sold had dropped by 40%, whereas treatment frequencies had only dropped by a few percent, when no correction is made for changes in crop rotation over the period.

Treatment frequency

Treatment frequency is an expression of the average number of times an agricultural area can be treated with the normal dose, based on the quantities sold. The average treatment frequency for 1981-1985, which was 2.67, is used as the reference for the first action plan's reduction target. The treatment frequency is considered the best indicator of effects on the environment.

Some crops are sprayed more than others, which is why crop rotation affects pesticide consumption and, thus, treatment frequency.

A numerical expression can be obtained, which describes the effect of changes in crop-rotation regimes (from the reference period (1981-1985) to today) on treatment frequency, by comparing treatment frequencies of the individual crops during the reference period, to the acreage covered by those crops in a given year.

This crop-rotation-corrected treatment frequency is obtained by multiplying the relevant acreage used for the different crops in a single year (e.g., 1997) by the treatment frequencies of the reference period. Calculation of how changes in crop rotation have affected the treatment frequency yields a value for 1997 of 3.27, which means that, with crop rotation as in 1997 and with treatment frequencies in the individual crops as in 1981-1985, the treatment frequency would have been 3.27, all other things being equal. For the sake of comparison, the treatment frequency in 1997 was 2.45, which is 25% lower than the value of 3.27.

Load indices, in which consumption is weighted with the toxicity of the products, showed a distinct drop in acute and chronic toxicity to humans and other mammals. The load indices for acute toxicity to birds and crustaceans had also dropped, whereas they remained unchanged for fish. Sales of products suspected of causing cancer remained at the same level as in the reference period.

Ground water policy

In the case of ground water, Danish environmental policy is based on prevention and initiatives at the source. This means that Danish ground water resources must be protected against further pollution and that the preventive effort against the pollution of ground water must be assigned higher priority than any subsequent treatment of polluted ground water.

Current approval practice endeavours to implement this policy. This practice is under constant review, with a view to incorporating the latest expertise in the field. The fact that approved pesticides have been found in concentrations above the limit for drinking water, near the surface and deeper, indicates that the current approval scheme does not give complete security against future pollution of our ground water.

Assessment of the approval scheme by international experts

One international study included a review of the general set of rules and the assessment input information used by the Danish EPA when processing applications. Several specific decisions were also reviewed. This international study included Geological Survey of Denmark's (GEUS) quality assurance of the Danish EPA's assessment input information on the risk of polluting ground water with pesticides. The most important conclusions of the international panel of experts state that the Danish approval scheme is one of the strictest in the EU, and that this fact (despite the fact that Denmark's geology is young and variegated) contributes to ensuring that the 0.1 µg/l limit for drinking water is not exceeded.

Chemicals Report of 1997

The Minister of Environment and Energy's 1997 account of forthcoming initiatives in the area of chemicals stated that a list of undesirable substances was to be promulgated. This list, which covers 100 substances whose use will be phased out, was published at the beginning of 1998. The list does not include the active ingredients of pesticides, but the individual auxiliary substances.

Chemicals strategy of 1999

At the beginning of 1999, the Minister of Environment and Energy presented a chemicals strategy, which contains the following main elements:

• The use of problematical chemicals must be reduced;
• The control of chemicals must be tightened and the responsibility of manufacturers shall be increased, while the access of consumers to information on these chemicals shall be secured;
• EU regulation must be tightened and a coherent, simplified, more efficient and faster EU assessment procedure shall be established;
• Danish efforts on behalf of the efficient, global regulation of chemicals must be reinforced;
• Danish environmental aid must contribute, e.g., to securing the establishment of competence in the chemicals area in the receiving countries.

This strategy is to be expressed in a number of specific national initiatives similar to the already advised regulation of phthalates in toys, lead, bottom paints and indoor paints containing solvents, together with the proposed amendments to the Chemical Substances and Products Act, which seek to finance the control of chemicals via the industry.

Furthermore, the strategy will be followed by a phthalates action plan, forthcoming accounts on PVC and on "Children and chemicals", together with the reports of the Bichel Committee.

The strategy will be undergoing hearings at authorities and interest organisations until mid-March.

5.5.2 Danish regulation of the pesticides field

The earliest Danish rules on the use of poisons were laid down as long ago as the end of the 1700s. An actual poisons act was enacted in 1931 and, in 1948, pesticides were separated from the poisons act and a special pesticides act was enacted. Both acts were amended in 1961 and, in 1980, were reunited in the Chemical Substances and Products Act, which has now been amended several times.

Before 1980, the purpose of the rules was to ensure that the use of pesticides did not incur dangers to humans, domestic animals or bees. The means for achieving this was to classify the products into danger classes "X", "A", "B" and "C", where danger class "X" was assigned to the most toxic products. For each danger class, rules on the labelling, storage, sale and use of the products were established, and the polluting or poisoning of wells and watercourses used for irrigation or bathing was prohibited.

Classification was carried out by the now defunct Toxicological Board, under the Ministry of Agriculture, but was transferred to the Danish EPA on its establishment in 1972. The Toxicological Board was abolished with the advent of the Chemical Substances and Products Act in 1980, and the administration of legislation on pesticides has since been the responsibility of the Danish EPA.

The legislation on pesticides is quite complicated. The main rules governing the approval of products can be found in Part 7 of the Chemical Substances and Products Act, although other rules of the Act also apply to pesticides. The most important of the Act's rules can be found in section 33 (1) which states that pesticides must be approved by the Minister of Environment and Energy prior to sale, importation or use. Contravention of this rule is punishable under section 59 of the Act.

In connection with this act, statutory orders on pesticides have been promulgated, which contain a wide range of specific instructions and requirements on the manufacturers, importers, dealers and users of pesticides.

Moreover, a number of special statutory orders and regulations sanctioned by the Act have been promulgated, e.g., on total or partial prohibitions against the sale of certain pesticides, on the classification, packaging, labelling, sale and storage of chemical substances and products, on training for commercial users and on aerial spraying.

A pesticide must not be imported, sold or used in Denmark unless it has been approved by the Danish EPA. Applications for approval must be sent to the Danish EPA by anyone who wishes to import or market pesticides in Denmark.

In the approval procedure, the Danish EPA assesses whether or not the use of a product would constitute an unacceptable risk to humans and the environment. The product is also assessed for its efficacy in the applications for which approval is sought.

Treatment respites (spraying respites) are stipulated on the basis of toxicological studies and studies of residual concentrations in plants.

Once granted, approval is usually valid for 10 years (pesticides) or eight years (biocides). Products classified as "Toxic" or "Very toxic" are only granted approval for four or five years. If an applicant wishes to maintain approval, he must apply for a renewal at least one year before the current approval expires.

When applying for approval, applicants shall present a number of studies. These studies are described in Annexes 5.1 and 5.3 to Danish EPA Statutory Order No. 241, of 27 April 1998, on pesticides.

Where the environment is concerned, requirements are set on data concerning the active ingredient's physico-chemical properties, its metabolisation and degradation in soil and water and its toxicity to aquatic organisms (fish, daphnia and algae) and terrestrial organisms (micro-organisms, earthworms and birds).

The data presented have normally been obtained from laboratory tests. In cases where these tests indicate that a substance is problematical, supplementary laboratory tests, or semi-field or field tests, are sometimes conducted. This is typically a matter of field studies of the degradability of the active ingredient, semi-field studies of mobility (lysimeter tests) or mesocosmos tests of toxicity to aquatic organisms.

In the area of health, requirements are set on a number of studies of the active ingredient, itself, and a smaller number of studies of the formulated product.

The active ingredient shall be tested for the following properties: acute toxicity, local irritation, dermal allergy, short-term toxicity (sub-chronic toxicity) long-term toxicity (chronic toxicity), carcinogenicity, genetic damage, damage to reproduction and the substance's metabolisation in the body. Some of these studies extend over several years and shall be conducted in at least two different animal species.

The formulated product shall be tested for its acute toxicity and for local irritation.

Based on these studies, the Danish EPA considers whether or not a pesticide is especially dangerous to health and the environment. In addition, the studies are used when classifying the pesticide.

Where the environment is concerned, the active ingredient is assessed on the basis of the application for which approval is sought, to determine whether it has an unacceptably long degradation time, whether it can leach into ground water in concentrations above the permissible limit or whether it can bioaccumulate in the environment. If such is the case, the pesticide cannot be approved.

When assessing whether or not the use of a pesticide presents an unacceptable risk of effects on aquatic or terrestrial organisms, the toxicity of the substance is compared to the concentration of the pesticide to which animals or plants will be exposed in the environment (the exposure). In this connection, distance requirements can be set when granting approval.

In cases where the exposure exceeds the safety margin required between the exposure and the concentration that results in unacceptable effects, a pesticide cannot be approved unless relevant semi-field and field studies of effects on aquatic and terrestrial organisms can prove that its use does not entail unacceptable effects.

It is only possible to account for less than 1% of the quantities of pesticides used in the different media. Information on total mass streams, including the evaporation, spray drift, degradation and metabolisation of pesticides, is lacking as part of the overall analysis. It is, therefore, impossible to describe the impact on health and the environment in detail.

From the standpoint of effects on health, the products are assessed to determine whether or not they have any directly or indirectly harmful effects on human health in normal use. The exposure that occurs in use is assessed for harmful effects. There must also be a certain safety margin between the exposure and the harmful dose.

The Danish Veterinary and Food Administration assesses the magnitude of the residual content that can be accepted in edible crops. Limits are specified for the maximum residual content, and spraying respites are set on the basis of this assessment.

In conjunction with the approval procedure, pesticides are classified according to guidelines that are common to the entire EU. The rules are amended and extended continuously, and are considered to be a reasonably satisfactory and usable system for describing the inherent toxicological properties of chemical substances. The classification of health effects covers acute and chronic effects. The acute effects are toxicity by ingestion, by dermal contact or by inhalation. The abilities to induce local irritation and dermal allergy are also classified.

In addition, classification is also done for chronic toxicity, carcinogenicity, mutagenicity, damage to reproduction and other types of damage that can be caused by exposure for longer periods.

Concerning the environment, pesticides are classified according to their toxicity to aquatic organisms, their potential for bioaccumulation and their degradation rate in the aquatic environment.

As part of the approval process, maximum residue limits are set for any pesticide residues in edible crops.

Limits are also set on the content in feed crops and animal products (meat, eggs and milk). The limits are set by the Danish veterinary and Foodstuffs Administration. To ensure that the limits can be observed, a spraying respite is also set.

A pesticide cannot be approved for use on an edible crop unless a residue limit has been set for the crop in question.

Recent years have seen more stringent requirements on documentation and the criteria for the approval of pesticides. This has resulted in the prohibition of many substances.

5.5.3 Auxiliary substances

When manufacturing pesticides, many auxiliary chemical substances are added, which include carrier substances, solvents, surfactants, dispersing agents, adhesives, absorption-promoting agents, antioxidants, bactericides, dyes, fillers and perfume. In 1997, about 69% of the sale of pesticides in Denmark consisted of auxiliary substances, which corresponds to about 10,000 tonnes. These auxiliary substances include a varied collection of chemicals, some of which are more toxic than the active ingredient, e.g., organic solvents. Some of these substances are included on the Danish EPA List of undesirable substances. Auxiliary substances have been in focus because of the organic solvents - most recently in 1997, when it became known that they included alkylphenols and alkylphenolethoxylates, which experimental studies have shown to have hormone-like effects in mammals. These substances are now being phased out, which means that many products are being reformulated with the substitution of auxiliary substances, whose known properties are deemed less harmful.

Approval of auxiliary substances

The auxiliary substances (or additives) in pesticides are not, themselves, subject to approval. The individual substances are subject to the same regulation as is described for chemicals, in the Chemical Substances and Products Act. Thus, no actual requirements are set on studies of the individual component substances of pesticides. However, the precise composition of the products shall be known to the authorities, so that all component substances can be identified. The Danish EPA can also require the data sheets for the individual additives. Such data sheets contain, e.g., brief information on the physico-chemical and toxicological properties of the additives, to the extent to which they have been studied. When assessing the additives, comparison is made to the list of dangerous substances, which shows the classifications of many chemicals (and pesticides).

Assessment of the toxicological properties of additives

To some extent, the toxicological properties of additives are apparent from the tests required of a formulated product. These tests include studies of acute toxicity by oral ingestion, by dermal absorption and inhalation, dermal and ocular irritation and, in certain cases, ecotoxicological studies in aquatic organisms, bees, earthworms, micro-flora, etc. If an additive has a serious long-term effect and is included in a product in a sufficiently high concentration, that product will be classified in accordance therewith and the use of the product will be subjected to exposure and risk assessments, even if the active ingredient is without alarming effects. The Danish EPA can withdraw its approval of a product solely on the grounds of an additive. Furthermore, additives shall be declared on the label, if they are present in the product in a concentration of 0.2% or more, for very toxic and toxic substances, and 5% or more, for corrosive substances or substances harmful to the health.

The Committee finds that the approval scheme should be extended, so that the requirements on additives approach the requirements set on the active ingredients of pesticides. Consideration should be given to banning all carcinogenic additives. We must emphasise that the additives are also used for purposes other than the manufacturing of pesticides. For this reason, there should be a general clamp-down on the use of auxiliary substances in all fields of application.

5.6 Present Danish regulation of organic farming

Pursuant to Act No. 363, of 10 June 1987, the Organic Foodstuffs Council was appointed under the Ministry of Food. Starting as early as the late 1980s, the Council took a number of initiatives that have helped to advance the development of organic farming. These initiatives led, e.g., to the establishment of possibilities for granting special subsidies to organic farmers.

Action Plan I

The most important new initiative was taken in 1995, in connection with the publication of the "Aktionsplan for fremme af den økologiske fødevareproduktion i Danmark" (action plan for promoting the organic production of foodstuffs in Denmark). This action plan, which was designed as a number of recommendations presented by the Ecological Agriculture Council to the Minister of Food, made a total of 65 recommendations, distributed over the following five main points:

• making restructuring for the organic production of foodstuffs attractive;
• ensuring a demand for organic foodstuffs;
• the reinforcement of research, development and training in the organic production of foodstuffs;
• removing the barriers to sustainable ecological development;
• ensuring implementation of the action plan for promoting the organic production of foodstuffs in Denmark.

Action Plan II

The task of developing organic farming has been followed up under the terms of Action Plan II - økologi i udvikling (on the way to sustainability), which was published by Danish Directorate for Development in February 1999. The aim of this action plan is - in extension of Action Plan I - to give the sector significant impetus towards further expansion, credibility and development in general.

Thus, Action Plan II expresses the desire to boost the further development of the organic form of production. This is to be achieved by not only increasing the extent of production but also by supporting organic farming in its efforts to attain the goals set for environmental and social sustainability, the production of healthy, quality foodstuffs and optimum animal welfare. Action Plan II therefore makes 85 recommendations in the areas of:

• consumption and marketing;
• primary production;
• quality and health;
• exports;
• institutions and institutional kitchens;
• the environment;
• the health and welfare of domestic animals;
• research and development;
• administrative rationalisation.

Other initiatives

Initiatives have been taken to promote organic farming in several areas. This is due to the fact that a number of restrictions have been imposed on conventional farming and that some of the initiatives have contained elements that focused on promoting organic farming. The most important initiatives are:

the pesticides action plan (1986) -
this plan had the goal of reducing the total consumption of pesticides;
the action plan on the aquatic environment (1986) -
the goal of this plan was to reduce discharges of nitrogen and phosphorus by 50 and 80%, respectively;
the marginal land strategy (1987) -
it was the purpose of this strategy to conserve uncultivated or extensively cultivated areas, to protect especially delicate areas and to mitigate the consequences of marginalising agricultural land;
action plan for the sustainable development of agriculture (1991) -
the overall objective of this plan was to ensure sustainable development in agriculture, e.g., by focusing on the production of healthy foodstuffs, and to avoid influences detrimental to the environment and nature in general;
the action plan on the aquatic environment II (1998) -
the goal of this plan was to reduce still further the loss of nitrogen and to secure the natural and environmental values of the "especially delicate territories". Moreover, this plan presumes increasing access to organic farms.

5.6.2 Danish legislation on the area of the ecology

The first Danish rules on organic agricultural production were laid down in Act No. 363, of 10 June 1987. In pursuance of this, rules were laid down on the authorisation and control of organic farms and on the processing, marketing and labelling of organic foodstuffs. The statutory order entered into force in the same year. This statutory order is now undergoing amendment, as is, for instance, the plan for securing better prospects for following the progress of the goods at all stages.

Due, for instance, to a sharp increase in the number of organic farms in the mid-1990s, pressure increased for more detailed rules on the area of domestic animals. For this reason, the Plant Department appointed a working group which, during the course of 1996, was to draft two reports, with recommendations on organic poultry keeping and cattle and pig keeping, respectively. These reports formed the basis for a new set of rules on organically-managed domestic animals. Further, the Plant Department has just issued a new statutory order that lays down more stringent rules - especially on poultry.

The rules that govern use of the ecolabel are laid down in the statutory order on the conditions for marketing organic foodstuffs.

Action plan II proposes a revision of the present rules.

Rules in the EU and at the international level

The EU Regulation on organic methods of production and on the indication thereof on farm produce and foodstuffs (Council Regulation No. 2092/91) came into effect in 1991. At the time of writing, the EU rules cover only vegetable produce. On 26 July 1996, the Commission of the European Community (CEC) presented a proposal for EU rules on the area of animals. This proposal is still being processed by a working party under the Council.

At the international level, work on rules for the ecology is in progress under the Codex Alimentarius (FAO/WHO). A proposal is expected to be completed during the summer of 1999.

Supervision

The ecology rules are supervised in Denmark by the Plant Department, which authorises and supervises organic farms. As far as slaughterhouses and processing companies are concerned, The Veterinary Department is the supervisory authority. The retail trade is supervised by local food inspectors.

5.7 Precautionary principle

The lack of information on the effects of pesticides on health and the environment has spurred a debate on the application of the precautionary principle to the area of pesticides.

The reason for applying the precautionary principle could be the uncertainty that is always associated with the data on which decisions are based, such as generalisations based on limited studies of the properties of pesticides, as well as the influences on, and reactions of, entire environmental systems or ecosystems and all of the species and populations that must be protected. In this connection, we must state that some ecological systems exhibit chaotic behaviour under certain circumstances.

The precautionary principle shall also make allowance for the risk linked to errors, and no-one wants any errors to affect the future significantly.

The precautionary principle can also embody a wish to give still better protection to especially exposed groups, such as children.

The 0.1 µg/l limit on the content of pesticide residues in drinking water is, thus, an expression of the precautionary principle, as quantities of this magnitude have no toxicological significance to humans. The 1986 pesticides action plan must similarly be considered an expression of the application of the precautionary principle because, to reduce the burden on the environment, it is necessary to reduce the use of pesticides as far as possible, since (as is emphasised as justification for the action plan) it is extraordinarily difficult to set an environmentally-acceptable level for the use of pesticides.

It has been stated in organic quarters that the rationale behind the precautionary principle has its foundation in the ecology's view of the interaction between man and nature, which is a central part of the ideology of organic farming. Organic farming is based on a view that nature comprises an entirety to which man is morally obliged to show consideration. Nature is perceived as a very complex, coherent system, for which reason man does not always have sufficient knowledge to grasp the consequences of various specific actions. Damage to nature and the environment can therefore be harmful to man in the end.

The Committee has noted an example of how work on drafting guidelines for the use of the precautionary principle is done at the European level.

Six principles for the application of the precautionary principle have been proposed in this context:

1. any application of the precautionary principle must start with an objective risk assessment, which identifies the degree of scientific uncertainty at every step;

2. when the results of the risk assessment are available, all relevant parties shall participate in the decision on the application of the different alternatives proposed. This process shall be as open as possible;

3. precautions based on the application of the precautionary principle must be proportional to the risk they are intended to limit or eliminate;

4. the precautions must also include a cost/benefit assessment (advantages/disadvantages) of reducing a risk to a level acceptable to all parties involved;

5. the precautions must assign responsibility for obtaining the scientific material necessary to a complete risk assessment;

6. the precautions must always be provisional, as they must await the results of the scientific research performed to obtain the scientific data for the subsequent renewed risk assessment.

The work is only a draft and must be seen as part of the process in which many players in the field try to advance their views on how to put the principle into operation. This draft is based on the risk assessment and any of its relevant uncertainties. It is, thus, a techno-scientific asset.

The sub-committees have included the greater part of the above principles in their discussions. The sub-committee on environment and health has discussed the various scientific uncertainties, whereas the sub-committee on production, economics and employment has discussed the feasibility of carrying out cost/benefit analyses. Finally, the sub-committee has carried out an assessment of the legal aspects in the EU when applying the precautionary principle.

We should emphasise the fact that the application of the precautionary principle takes place in interaction between the following parties:

1. scientific expertise, which must draw the line for what is foreseeable and isolate that which cannot be clarified;

2. an administrative effort, which must adopt a stance on what can be put into operation;

3. a political opinion, i.e., non-expert, which, with consideration for the population, must make a decision on the basis of its confidence in expert knowledge and of ethical and political considerations.

5.8 Research on pesticides and the ecology

Pesticides

A certain amount of research has been conducted under public auspices, with the intention of clarifying the environment and health-related consequences of pesticide use. Worthy of mention are:

• the pesticide research programme;
• the interministerial pesticide research effort;
• the strategic environmental research programme;
• the monitoring programme of the action plan on the aquatic environment.

The pesticide research programme

The pesticide research programme has been working on four main areas of research since 1992:

• the occurrence and effects of pesticides and other plant protection measures in the vicinity of cultivated land;
• the incidence of environmental effects of pesticide residues in ground water, surface water and air;
• the occurrence and health-related effects of pesticides in the workplace;
• the development of integrated methods of protection and prevention.

Interministerial pesticide research

Interministerial pesticide research also covers the topics of:

• the exposure, fate and effects of chemical pesticides and other protective measures in treated ecosystems;

• the fate and environmental effects of chemical pesticides in the areas adjoining treated ecosystems;

• the exposure of people to pesticides and assessment of the health-related consequences;

• the development and implementation of integrated methods of protection and prevention.

The strategic environmental research programme

The strategic environmental research programme is built up around a number of programmes, of which the following are relevant to pesticides:

• the Danish centre for ecotoxicological research;

• the centre for the biodiversity of arable land;

• the centre for biochemical and industrial epidemiology;

• pesticides and ground water;

• the occurrence and effects of hormone-like substances on reproduction.

Monitoring programme of the action plan on the aquatic environment

The above programme has undertaken an analysis of the incidence of 8 pesticides in ground water. The results are described in a GEUS report, Grundvandsovervågning 1996 (ground-water monitoring), of December 1996.

The monitoring programme is constantly revised to accommodate new substances.

Organic farming

Several initiatives have been taken in the field of research policy, to support the development of organic farming. The first research projects in the area were launched at the end of the 1980s, at the instigation of the Organic Foodstuffs Council. In 1992, a report and an account of research in organic farming were drafted, and were presented to the Folketing by the Government. The account led to the establishment of a research effort, "Forskning i økologisk jordbrug 1993-1997" (research in organic farming, 1993-1997), with total funding of DKK 50m.

Furthermore, the publication of "Den nationale strategi for jordbrugsforskningen" (the national strategy for research on farming) gave additional impetus to research in this area. This strategy, which was published in June 1994, was the result of an extensive investigation of the overall goals of Danish agricultural research. The recommendations adopted on the implementation of this national strategy express the concept of sustainability in no less than four of the six main recommendations on the goals to which future agricultural research should contribute, i.e.:

• to reduce the number of target factors in agriculture, with a view to reducing both costs and impact on the environment;

• to reinforce the knowledge base on alternative forms of production, including the non-food use of biomass and organic farming;

• to increase the knowledge base on appropriate extensification, set-aside and land management;

• to increase the knowledge base on the sustainable development of the rural districts.

However, research received its greatest boost as a result of Action Plan I, from 1995, one of the main points of which was to reinforce research, development and training in the organic production of foodstuffs. As a result of this action plan, the Danish Research Center for Organic Farming (DARCOF), was established at the end of 1996, with the goal of co-ordinating and promoting collaboration in the field of organic agricultural research. DARCOF is a "centre without walls", which means that the researchers remain in their own environments, but work together across institutional boundaries. At the time of writing, this collaboration involves about 100 researchers, from 14 different research institutes, and the research effort receives about DKK 35m annually.

Action Plan II also has the goal of giving an additional lift to research on organic production. One of its recommendations is that the level of grants for current research activities be doubled up to the year 2003, at the minimum.

5.9 Other matters

The mycotoxins are a general problem in conventional and organic farming, as they can proliferate under climatic conditions of high humidity. They can also proliferate if grain is dried too slowly. Mycotoxins from fungi in grain can constitute a threat to the population, and consideration should be given to improving monitoring of the mycotoxin content of food.

5.9.2 Soil preparation, mineralisation and energy consumption

Soil preparation is expected to increase as pesticides are phased out. The reason for this increase would be to keep the pressure from weeds sufficiently low. Soil preparation would be a combination of ploughing, harrowing and hoeing.

Soil preparation affects chemical, physical and biological factors in the soil and, therefore, is indirectly of great importance to mineralisation and the release of nutrient salts and their possible leaching, as well as to the persistence and leaching of pesticides. If soil preparation were to be increased, it would mean the destruction of some of the macropores. In turn, this would mean that the residence time of pesticides in the ploughing layer (where the degradation potential is highest) would probably increase and leaching would probably decrease, although it would also increase surface runoff. If soil preparation were to be reduced or eliminated, transport in macropores would increase, whereby the leaching of pesticides would also increase. Whether or not this would be the case under Danish conditions is unknown.

In comparison to normal soil preparation, reduced preparation could also increase the evaporation of pesticides when the soil is not prepared. If soil preparation were to be reduced, the content of organic material would increase in the long term. This would mean, for instance, that soil porosity would also increase and, thus, the soil's degradation potential, and its pesticide degradation kinetics would change. The effects of soil preparation on the metabolisation of pesticides, as well as on evaporation, are therefore vital.

The mechanical control of couch grass in the autumn is considered to have a deleterious side effect, in the form of increased nitrogen leaching during the winter half of the year, due to the increase in nitrogen mineralisation. It is also known that mechanical weed control in the spring accelerates the nitrogen cycle. This is often considered to have a beneficial effect on crops, which have good prospects during the growing season of utilising the nitrogen released.

In general, slightly larger populations of weeds are expected when mechanical weed control is used, as opposed to chemical weed killers. However, our knowledge of the flora effects that will occur on different types of farm is very limited.

Soil preparation is also important to the fauna. Increased soil-preparation frequency could be harmful to soil organisms, such as earthworms and springtails, and it could also pose a threat to birds that nest on arable land.

If we wish to sustain our production of domestic animals in Denmark, restructuring for pesticide-free farming would result in a net increase in energy consumption; see Table 5.15. This increase would primarily be due to the increased energy costs of feed imports, because the yield drops in the 0-scenario. On the other hand, the energy costs for crop production would drop, primarily due to the energy saved in the manufacturing of pesticides and to the diminishing use of nitrogen from commercial fertilisers.

It is possible that a number of the conditions related to changes in operation, which have not been taken into account, could increase the energy consumption of pesticide-free farming. Reduced soil treatment is, for instance, more difficult in the pesticide-free scenario which, in this scenario, incurs additional energy costs due to the need for increased soil preparation. There is, however, experience to indicate that competitive late crops can reduce the need for mechanical weed control (which is relatively energy-consuming) in the autumn. It is also necessary to include in the energy scenario the energy costs for drying crops and for changes in the use of straw for energy purposes. Similarly, there are items that have not been included in calculating the consequences of pesticide-free farming, but which could reduce the energy costs. For instance, it may be necessary to establish new artesian borings because of pollution of the ground water, or to take steps to protect the surrounding countryside.

Similarly, no position has been adopted on the extent to which a different production pattern, such as organic production or reduced production of domestic animals, would affect energy consumption.

Example of the calculation of energy consumption for the cultivation of winter wheat in Present Cropping (1996) and in pesticide-free agriculture.

*) incl. harrowing, extra harrowing after harvesting, etc.

**) 100% commercial fertiliser

Agriculture's contribution to the greenhouse effect is about 13 Tg CO₂ equivalents. Of this, CO₂ derived from the consumption of fossil fuels, accounts for about a quarter. The remainder of agriculture's contribution to the greenhouse effect comes from methane and laughing gas. Compensation for the reduced yield when importing fodder means that energy consumption would be higher than when using pesticides. Changes in the release of methane and laughing gas have not been taken into account in our assessment of the change in agriculture's contribution to the greenhouse effect, when switching to pesticide-free operation.

5.10 Ranking of pesticides

At the time of writing, working groups have been started in the OECD and EU to examine the feasibility of ranking pesticides. The working groups have not, however, completed their tasks yet.

An assessment of the feasibility of ranking pesticides on the basis of data obtained from the approval scheme was carried out in association with the Committee's work.

It has not proved possible to rank pesticides according to their ability to leach into ground water. Four different methods (the GUS index, the Hasse diagram, the AF index and an expert assessment) have been used to draft a gross list, which covers 35 substances. The substances on this list should be subjected to more rigorous assessment along the lines of the approval scheme.

Over the coming years, research programmes now in progress will improve the knowledge base on the fundamental problems. The improvements now started in the monitoring of ground water, and an advance warning of any risk that pesticides could percolate down to ground water, will increase safety.

An improved risk assessment of percolation requires further work on clarifying the processes that control the transporting of pesticides to ground water and into ground water deposits.

In connection with the arrival of the results of an ever-increasing number of studies (national and international), we should develop decision-making tools (based on statistically-documented relationships involved in the percolation of pesticides), with a view to generalising the studies to encompass uninvestigated areas and pesticides.

In connection with the increasing use of mathematical models (such as MACRO) for assessing risks of pesticide percolation, we should devote more work to assessing their validity. In this context, there is a special need for obtaining the necessary geological and substance-specific data. The practicability of developing simple stochastic (probabilistic) models should be studied.

As far as the terrestrial environment is concerned, it is not possible to suggest a method for ranking the direct effects, as the indirect effects and the combination of many pesticides play the greatest part.

However, treatment frequency can be used as a measure of the impact, as it is based on the biologically active field dose and can, thus, be used as a simple indicator for the direct effect on target organisms and for the indirect impact on the ecosystem, which results from changes in the quantities and species found in the food chains.

It will also be possible to calculate an index for the dose that is harmless to by far the greater part of the animals and plants in uncultivated areas, which receive pesticides through spray drift or atmospheric transport (tolerance limits).

The present approval scheme is now conducting an expert assessment of the aquatic environment, which could lead to new pesticides or products being granted approval conditional on the observance of a given distance from watercourses and lakes. Such requirements on distance indicate that pesticides are problematical in relation to aquatic organisms, and they would be immediately usable for ranking or grouping the pesticides.

In the field of human toxicology, it is desirable to use the classification of active ingredients as the basis for ranking. It would also be possible to use the distance between the ADI and the estimated exposure as a ranking basis. This would make it possible to identify the substances that have the lowest safety margin for humans in relevant applications. However, as the effects are not directly comparable, a ranking scheme could not stand alone, but would need to be supplemented with an expert assessment.

5.11 Other applicable legislation

The present Danish legislation on pesticides is described in Chapter 5.5 and the current Danish regulation of organic production is described in Chapter 5.6. This section will discuss EU law, WTO law and the rules of the Danish constitution on expropriation.

5.11.1 EU law

In the Treaty on European Union, the articles on technical trade barriers (Arts. 30 and 36), state subsidies (Art. 92), customs duties and charges on good (Arts. 9-12 and 95) and the environmental guarantee (Art. 100a(4)) are of particular relevance to any assessment of the feasibility of a total or partial phase-out of pesticides.

Directive 91/414/EEC, on the marketing of plant protection products, is central to any legal assessment of the feasibility of a total or partial phasing-out of pesticides and of the feasibility of setting requirements on restructuring for organic production. One of the effects of this directive is that it is only under certain circumstances that Denmark can refuse to approve the sale of a pesticide within its borders, when it has already been approved in another Member State. A number of other directives, such as the directive on drinking water and the directive on habitats also concern the regulation of pesticide use. Finally, a number of directives on pesticide residues regulate the setting of limits for pesticides in foodstuffs.

Denmark is a member of the WTO directly, and indirectly, through the EU.

It can generally be said that, to the extent that any intervention in the sale or use of pesticides, or any requirement on restructuring for organic production, is acceptable to other Member States or pursuant to EU rules, corresponding intervention in this area is acceptable to third countries pursuant to WTO law.

5.11.3 Constitutional rules on expropriation

If legislation for reducing pesticide use is enacted, it would be intervention in the affairs of the farming community. We have therefore considered whether or not such legislation would conflict with section 73 of the constitution, if it were implemented without compensation, and whether or not demands for compensation would in such case be made on the direct basis of section 73 of the constitution.

We assert that, pursuant to section 73 of the constitution, it would be possible to implement (normally without compensation) a prohibition of the sale and use of pesticides or a compulsory restructuring for organic production.

5.11.4 Legal assessment of means for phasing out pesticides

Bearing in mind the legislation mentioned above, a legal assessment has been made of a number of options concerning the total or partial phasing-out of pesticides. These options are, e.g.:

• prohibition (total or partial) of the sale and/or use of pesticides;
• quotas for the use of pesticides;
• tightening of the pesticide approval scheme;
• requirements on the marketing of pesticides (such as rules on advertising, authorisation and sales outlets);
• higher surcharges on pesticides;
• agreements with the agricultural industries, on reducing the use of pesticides;
• self-regulation of the use of pesticides in the agricultural industries;
• requirements on training the users of pesticides;
• lower thresholds for pesticides in foodstuffs.

Moreover, a legal assessment has been made of a number of options concerned with restructuring for organic production.

Prohibitions against sale and use

We distinguish between prohibitions against the sale and use of pesticides in the transitional period (up to 2003, at present) and after that period.

Prohibitions against sale and use in the transitional period

During the transitional period (i.e., until 2003, on condition that individual active ingredients are not added to the EU positive list), Denmark can establish general and specific prohibitions against the sale and use of pesticides that have not been added to the positive list. There is however a condition, i.e., that any rules of the type discussed conform to Arts. 30 and 36 of the Treaty on European Union. This means that such rules shall have an objective, environmental or health-related foundation, that the scope of the rules must not extend further than necessary and that there are no alternative means of regulation, which would constitute a lesser obstacle to commerce. The transitional period is set to expire in mid-2003, although it must be expected to be prolonged for several substances, if they have not been reassessed by that time.

Prohibition against the sale of specific pesticides after the transitional period

After the transitional period (i.e., when the individual active ingredients have been added to Denmark's positive list), we will have to distinguish between pesticides for which approval is sought in Denmark (with reference to the fact that a pesticide has already been approved in another Member State pursuant to the common EU rules) and pesticides for which the initial application for approval is made in Denmark.

Pesticides approved in another Member State

The crucial question is whether or not Denmark can refuse to approve the sale of a pesticide in this country after the transitional period, when it has already been approved for sale in another Member State.

After the expiry of the transitional period (2003), Denmark will only exceptionally - and then only within certain limits - be able to refuse to approve the sale of a specific pesticide, if it has already been approved in pursuance of the rules of the Directive in another Member State, cf. Directive 91/414/EEC, Art. 10.

Pursuant to this article, Denmark will be obliged to approve the sale of a pesticide here if it has been approved by another Member State and if the applicant has presented tangible proof that the conditions for mutual recognition are satisfied (mutual-recognition obligation).

Denmark can, however, deny approval (but only within certain limits). A denial would be possible if it were possible to document the existence of different conditions in Denmark (lack of comparability), from the standpoint of conditions of agriculture, plant health and the environment, including the climatic conditions, under which a product would be used.

One example could be that if, in comparison to the corresponding conditions prevailing in the original country of approval, the precipitation and agricultural conditions in Denmark were found to be of such character that a product could percolate down to the ground water in concentrations above the threshold for drinking water.

The Commission must be notified if Denmark wishes to reject a pesticide approved in another Member State and an EU Committee Procedure must be conducted, to decide whether or not a rejection would be legitimate according to EU rules.

If the conditions that constitute the difference between Denmark and the original country of approval could be alleviated by relatively modest measures, e.g., a ban on spraying in the autumn, there would be no basis for banning the sale of a plant protection product, but only for setting (such) national requirements on use.

All things considered, the requirement on mutual recognition (Art. 10) imposes stricter restrictions on Denmark's freedom for action, in cases where a pesticide has been approved for sale in another Member State.

First-time approval

Denmark has a little more freedom if approval is sought for a pesticide that has not been approved in another Member State or if mutual recognition pursuant to Art. 10 of the Directive is not invoked by the applicant (first-time approval).

Our point of departure is that there is no obligation to give notification of first-time approvals. No such obligation is laid down in Directive 91/414/EEC.

When processing first-time approvals, however, Denmark must respect the uniform principles for the assessment and approval of pesticides, as laid down in Directive 97/57/EU. These principles (which are of a technical nature) are, however, somewhat flexible, as many ancillary assessments must be made when assessing the results of studies, etc. The uniform principles assert, for instance, the possibility of denying approval with reference to the principles of "integrated control"; see more on this topic below.

There is no EU Committee Procedure when rejecting a first-time approval (in contrast to what applies when rejecting a pesticide that has already been approved by another Member State), but an interested party can appeal to the CEC, which can institute proceedings at the EU Court.

Should Denmark refuse to grant first-time approval, and should the manufacturer in question subsequently apply for and obtain approval in another Member State, Denmark would (following a renewed application) be obliged to approve that pesticide (mutual recognition pursuant to Art. 10), provided that the conditions of Art. 10 were satisfied.

All in all, Denmark has a certain degree of freedom in the case of first-time approvals, although this freedom could be diminished if a manufacturer who has received a rejection were to obtain approval in another Member State.

General prohibition against the sale of pesticides

Directive 91/414/EEC only regulates questions concerning specific approvals of the sale of specific pesticides, including the requirement on mutual recognition of specific approvals in other Member States.

Thus, the Directive does not regulate the question of a completely general ban against the sale of pesticides as such in the individual Member States, and so the Directive presents no obstacle to a general, national, Danish prohibition against the sale of pesticides.

However, when confronted with a general ban, it would be possible to take advantage of loopholes, which should therefore be assessed with respect to Directive 91/414/EEC. The reason for this is that a general ban on the sale of pesticides would mean that pesticides, which are approved for sale in other Member States, could not be sold in Denmark.

Under all circumstances, it must be assumed that a general ban would only be acceptable if, for each individual pesticide that is approved in another Member State, it were possible to justify the ban on the grounds of overmastering conditions pertaining to health, the environment, etc. In other words, the ban must be subjected to assessments of impartiality and proportionality, cf. EU Court practice concerning Arts. 30-36 of the Treaty on European Union.

On the whole, a general ban on the sale of pesticides in Denmark appears, thus, as a purely theoretical option, which it would be difficult to implement in practice.

As can be seen from the foregoing, the viability of a general ban on sales is limited, where pesticides approved in other Member States are concerned. Consideration should therefore be given to the possibility of an individual Member State, when it is not able to ban the use of a pesticide, setting instead conditions that restrict the prospects for using that pesticide.

In connection with the mutual recognition of approvals issued in other Member States, the Committee considers that, within the formal and factual framework described below, Denmark can impose usage and acreage restrictions when granting first-time approvals of pesticides. Concerning the possibility of setting conditions on use with reference to the principles of "integrated control", see the description below.

As far as first-time approvals of pesticides and mutual recognition of approvals granted in other Member States are concerned, a basic condition is that the usage and acreage restrictions be substantiated, relevant and proportional in relation to the intended goal, as well as non-discriminatory.

Concerning the mutual recognition of approvals issued in other Member States, there is an additional condition, i.e., that the usage and acreage restrictions, which are justified for reasons of the health of dealers, users and employees, or by nutritional considerations, are within the framework imposed by Art. 10 of the Directive.

Another condition with respect to mutual recognition is that usage and acreage restrictions justified by conditions relevant to agriculture, plant health and the environment, including climatic conditions, be designed to reduce the significance of a lack of comparability. Furthermore, it is a condition that these usage and acreage restrictions either be accepted by the applicant or be subsequently endorsed by an EU Committee Procedure.

The Committee is of the opinion that, in relation to the EU rules and the expropriation rules of the Danish constitution, it would in principle be possible to implement a ban (normally without compensation) on the use of pesticides. Such a ban could cover pesticides as such or groups of pesticides. Similarly, it would in principle be possible to include all Danish land or smaller parts thereof.

One prerequisite is, however, that such a ban on the use of pesticides conform to Arts. 30 and 36 of the Treaty on European Union. This means that such rules should be based on unbiased, environmental or health-related grounds, that the scope of the rules not extend further than necessary and that no alternative regulatory instruments exist, which would constitute lesser obstacles to commerce.

The greater the areas covered by a ban, and the more the ban applies to pesticides approved in other Member States, the weightier and more convincing the environmental or health-related grounds must be.

A ban on use set, e.g., on a group of products, could assume so product-specific a character that it could be considered an evasion of the conditions for approval laid down in Directive 91/414/EEC. In such case, that ban would only be accepted if it were to satisfy the conditions for denying the approval of sales, as laid down in Art. 10 of the Directive.

Restriction of the use of pesticides can be established in the form of a quota system. There is, however, a requirement that the quota system satisfy the above requirements laid down on general bans on the use of pesticides.

In connection with the approval of pesticides, there are certain so-called "safety factors" in the assessment input information. If it were possible for the individual Member State to specify these safety factors for itself, it could mean a further tightening of the approval scheme, which would mean further restriction of the pesticides that can be sold in Denmark.

The Committee is of the understanding that Directive 91/414/EEC prevents Denmark, when assessing the environmental effects of pesticides, from applying safety factors higher than those stated in Directive 97/57/EU (on the uniform principles for the assessment and approval of pesticides).

Moreover, it is the opinion of the Committee that Denmark, when assessing the health-related effects of pesticides, can apply its own safety factors for the time being as, at the time of writing, neither general nor specific binding rules on health-related safety factors have been laid down at the Community level.

National provisions thereon must conform to Arts. 30-36 of the Treaty on European Union. This means that such provisions shall be based on impartial, health-related grounds, that the scope of the provisions shall not extend further than necessary and that no alternative regulatory instruments (which would constitute lesser obstacles to commerce) be available.

Thus, in the long term, there are probably no options for the independent, national tightening of the approval scheme through the application of special safety factors.

In association with the foregoing review of administration of the approval scheme, including the options for denying approval (sales ban) and setting conditions on use, it is worth noting that, within the framework of the Directive, Denmark can refuse to approve pesticides, or can set conditions on their use when granting approval, with reference to the Directive's rules on integrated control.

The rules mean that, where appropriate cultivation and pest-control standards (which do not cause unacceptable damage or loss) can be stipulated for a specific crop, it is possible partially or totally to refuse approval of a product. At the time of writing, the concept of "integrated control" has not been defined in greater detail in the context of the EU.

Any denial of approval or imposition of conditions in accordance with the principle of integrated control would, however, require that the Danish authorities be able to refer to relatively certain studies or other input information, which document that the pests can be controlled partially or totally by alternative means or methods.

Furthermore, there must be a requirement on the availability of specific assessments of the economic consequences of the minimum use of pesticides in individual crops in Denmark.

If Denmark can relatively quickly define technically and economically well-founded principles for integrated control, it would be able to influence the more detailed specification or completion of the provisions of Directive 91/414/EEC and Directive 97/57/EU, and thus the total real content of the EU rules on the marketing of pesticides, in the direction of lower consumption of such products.

We consider that Denmark has a certain degree of freedom concerning the general regulation of pesticide marketing methods. For instance, it would be possible at the national level to declare that pesticides only be sold through heavy-goods outlets, whose customers are primarily farmers, and that the products only be sold to specially trained persons.

Additional surcharges on pesticides could serve as an instrument for attaining reduced use of these products.

Against the background of experience of pesticide surcharges to date, we can say that, in themselves, they have not caused difficulties with the EU. It is difficult to determine whether or not there is a legal upper limit to the magnitude of such surcharges. Refunding of the surcharges to the agricultural sector would be within the scope of the EU rules on state subsidies and would, therefore, require the approval of the EU.

The Minister of Environment and Energy and the agricultural industries could enter into agreements on reducing the consumption of pesticides. Such agreements could be supplemented with legislation or other rules.

As the Minister would be a party to the agreements it would, according to circumstances, be necessary to report them to the CEC pursuant to Directive 98/34/EU on information procedures. The extent to which agreements between private and public parties are covered by Arts. 30-36 of the Treaty on European Union is unclear, but the CEC would need to adopt a position thereon in connection with any report.

If the agreements are supplemented with subsidies, they would need to be approved by the CEC, pursuant to the rules of state subsidies in the Treaty on European Union.

Self-regulation

Another way of reducing the use of pesticides is through voluntary agreements within the agricultural industries or between them and other industries.

One practical example of this is an agreement between agriculture and the flour and bread industry, the purpose of which is to ensure that any grain used for bread production in Denmark has not been treated with "Round Up" or other products containing glyphosate.

Such voluntary restrictions pose no difficulties in relation to the EU. However, no position has been adopted on the relationship of such agreements to the rules on competitiveness.

In 1993, the Minister issued a statutory order on the training of commercial users of pesticides. It would be possible to sharpen the training requirements without coming into conflict with the EU rules.

The Committee is of the opinion that, in the long term, Denmark cannot set limits on pesticide residues in foodstuffs other than those set by the EU.

The Committee considers that requirements on restructuring for organic production are hardly feasible within the framework of the applicable EU rules. This is because organic production would entail significant restrictions on the use and sale of pesticides and conventional foodstuffs. Compulsory restructuring for organic production would demand that the conditions for a general prohibition of the use of pesticides be satisfied, cf. the foregoing.

Denmark cannot unilaterally ban the importation of non-organic foodstuffs because of the Treaty on European Union rules on the free movement of goods, cf. Arts. 30-36.

EU rules permit the labelling of foodstuffs as being organically produced. If Denmark were to implement such a scheme, however, that scheme would need to be open to manufacturers who satisfy the conditions of Regulation No. 2092/92 in other Member States. It is not possible to set a general requirement in Danish legislation on the labelling of Danish foodstuffs as being manufactured in Denmark. On the other hand, the agricultural industries can voluntarily establish such a labelling scheme.

According to applicable EU rules, there is a possibility of granting EU subsidies to organic production within certain limits. These rules were undergoing amendment at the time of writing and will scarcely be able to subsidise compulsory organic production.

A purely Danish scheme for supporting organic production would require EU approval in pursuance of Arts. 92-93, on state subsidies, of the Treaty on European Union. The Committee is of the opinion that it would be difficult to obtain such approval, as this would be a question of operating support for an entire industry.

However, it would be possible to impose surcharges on conventional agricultural products, to the extent that such surcharges do not differentiate between foreign products in relation to home products. Pursuant to the 6th V.A.T. directive, it would be possible to levy lower V.A.T. rates on organic foodstuffs than on other foodstuffs.