9.4.1. Plant protection products:
Since 26 July 1993, the placing on the market of plant protection products in the EC has been regulated through Directive 91/414. The legal justification for the Directive is Article 43 of the Treaty of Rome (on agricultural harmonization).
Directive 91/414 stipulates regulations on uniform authorization procedures as well as a number of transitional regulations such that over the next 10 years or so, Member States will to a greater and greater extent approve plant protection products according to the same principles. The Directive is a framework Directive, and is currently being expanded upon by means of a number of daughter Directives that stipulate detailed regulations for the uniform authorization procedure.
What determines whether a plant protection product is to be authorized in accordance with the Directives uniform authorization procedure or the transitional regulations is whether or not the active substance that the plant protection product contains is included in Annex I of the Directive.
If the active substance is included in Annex I of the Directive, authorization of the plant protection product shall follow the uniform principles stipulated in Annex VI. The latter is formulated as a Directive (94/43), and in daily usage is referred to as the Directive on Uniform Principles for the Evaluation of Plant Protection Products. It is one of a number of daughter Directives that expand upon Directive 91/414.
As yet no active substances have been included in the Directives Annex I, but both existing and new substances will be included on the list over the next 10 years or so. New active substances are those placed on the EC market after 26 July 1993. Existing substances, i.e. those on the market before that date, are to be re-evaluated in the Community in accordance with a specified work programme. There are approx. 800 existing active substances on the EC market. The decisions will be made by the Standing Committee on Plant Health, and the latter will therefore come to play a key role in this area.
In the case of plant protection products not included in Annex I, Member States shall consider applications in accordance with a set of general requirements stipulated in Annex III of Directive 91/414. In addition, a prohibition Directive has been in effect since 1979 that prohibits the placing on the market and use of plant protection products incorporating a number of particularly dangerous active substances, e.g. DDT and products incorporating mercury compounds. It will not be possible for these active substances to be included in Annex I of Directive 91/414.
In Denmark, plant protection products were also regulated prior to the establishment of the Ministry of the Environment in 1973. Administration of such products then lay with the Ministry of Agriculture and Fishery, and the authorization only gave consideration to man and animals.
The Ministry of the Environment took over the area in 1973, and the new Chemical Substances and Products Act in 1979 introduced consideration to the environment. This rapidly became of importance for the authorization of new substances, the Danish requirements for information being very extensive and in line with those of Sweden and USA. Around ten applications for the authorization of new active substances are received each year in Denmark. The branch reports that it costs approx. USD 10 million to develop a new active substance and have it authorized. The case officers in charge of an authorization have to study reports that together typically occupy 2-3 metres of shelf space.
However, it is still the existing products that play the greatest role, both in terms of quantity and the environmental problems associated with them. Invoking powers under the 1979 Act, the Ministry of the Environment therefore tried to impose requirements on existing substances by requiring their reevaluation. However, this was overruled by the Environmental Board of Appeals. Parliaments answer to that was a 1987 amendment to the Act that gave the Ministry of the Environment the powers to require re- evaluation of the existing substances.
A total of 216 active substances should have been re-evaluated, corresponding to 1,232 products. Some active substances were immediately withdrawn from the Danish market, however, either because the market was too small or because the necessary documentation could not be procured; as a result, 82 of the active substances disappeared from the Danish market.
Of the remaining 134 cases on active substances, a decision has not been reached in 36 cases (early 1995), while 73 cases resulted in the active substance being authorized and 25 cases resulted in authorization being refused.
Virtually all 25 refusals were appealed to the Environmental Board of Appeals, thereby initiating a process taking many years. As appeals have a postponing effect, the substance - and hence a large number of products - can still be marketed while the appeal is pending. At the time of writing (mid 1995), a ruling has not been made in any of the appeals.
Worries about the impact of plant protection products on the groundwater resource sparked off a new political initiative, however. In May 1994, Parliament passed an Act that prohibited the sale or use in Denmark of plant protection products incorporating 7 specified active substances12. The active substances in question either threaten the groundwater resources or are highly persistent in the soil. In addition, on the basis of the new law the Danish EPA in 1995 initiated a procedure for prohibiting products containing phenoxy acids. It is intended to complete the procedure before the end of the year.
The Ministry of the Environments intention with re-evaluation of plant protection products - and with the accompanying political initiatives - has been to remove from the market those products most harmful to the environment.
An additional important aim is to persuade farmers to spray less and less often. In 1987 the Ministry of the Environment published a plan that amounts of active substance were to be reduced 25% by 1990 and a further 25% by 1997. Application frequency was to be halved from 2.67 times a year to 1.34 times a year.
The amount of active substance consumed has actually fallen by 40% (from 7,000 tonnes in 1980-85 to 4,100 tonnes in 1993). However, this is hardly due to the endeavours of the Ministry of the Environment, the latter having little influence among farmers. The explanation is rather that more specific active substances have been developed that are active in smaller amounts than previously.
Application frequency has remained unchanged. It is therefore still on the political agenda. Farmers are dissatisfied with using application frequency as a measure because it does not take into account the different degree to which products affect the environment; moreover, they consider that in general, they now use less harmful products.
In recent years a requirement has been introduced that commercial users of plant protection products shall undergo obligatory education in their usage. Moreover, a requirement for farmers to keep a spraying journal has recently been introduced under agricultural legislation.
Progress from the passing of the Chemical Substances Act in 1979 up until the early 1990s has been modest. A 1987 Action Plan, which lacks any means of control, does not seem to have had any effect either.
However, around 1993 serious efforts were initiated to analyse Danish groundwater for pesticide residues. The results showed unexpected pollution. At roughly the same time it was acknowledged in Denmark that within a few years it will be the EC that determines the pace in the area on the basis of Directive 91/414.
As a result there is now considerable activity in the area. In addition to the above mentioned 1994 Act prohibiting seven active substances, more prohibitions are on the way. Farmers seem readily able to accept this type of intervention - they are understanding of the need to protect the groundwater against pesticides.
The trend in Denmark with regard to groundwater and pesticides may well have an impact on the implementation of Directive 91/414, i.e. for which substances are included on Annex I. This is probably also the intention from the Danish side.
While there has been a clear fall in pesticide use by farmers measured in terms of tonnes of active ingredient, the frequency of application has hardly changed. It is a point of discussion between farmers and the Ministry of Environment and Energy as to how the two sets of figures should be interpreted. However, by imposing a levy on pesticides in 1995 the legislative powers have now placed pressure on the farmers (see Section 12.2.6).
9.4.2. Biocidal products:
Substances belonging to this group of pesticides include wood protection products (annual consumption 1,300 tonnes), rat poisons, products for combating water voles, mice, moles and textile pests.
Consumption of plant protection products (1987-93)
The EC has not yet regulated this area, although the Commission has submitted a proposal to the Council on the placing on the market of biocidal products. As with the other regulations that apply to plant protection products, an authorization procedure is proposed. In addition, the general restrictions on the placing on the market and use of dangerous substances and preparations, (Directive 76/769), are also applicable here.
In Denmark, biocidal products have been subject to the same authorization procedure as applied to plant protection products until the latter became subject to EC regulation through Directive 91/414.
Progress as a result of the regulation of these products is seen in the
withdrawal from the market in 1991 of a number of products incorporating arsenic and
chromium. The last exemption for an arsenic-containing product expired in 1993, while
there are still valid exemptions for chromium-containing products for a few uses.