The general exposition in chapter 5 is followed below by a legal assessment of a number of regulatory instruments that could be used for phasing out the use of pesticides in the agricultural industries.

The main question is whether Danish legislation introducing or expanding such regulatory instruments is possible in relation to EU law.

6.1 Regulation in the transitional period

Directive 91/414/EEC on the placing of plant protection products on the market includes a 12-year transition period that ends in mid-2003, cf. Article 8(2) of the directive (see section 5.1.5 above).

The transitional period is noteworthy for two reasons. Firstly, it is relatively long and, secondly, for the individual active ingredient, it expires before the year 2003 if the substance in question is assessed with a view to inclusion in Annex I to the directive.

Concerning this assessment of active ingredients, it is stated in Article 8(2) of the directive that the Commission shall commence a work programme with a view to reassessing the active ingredients that were on the market before the time limit for implementation (26 July 1993), so that they can perhaps be included in Annex I to the directive (the EU’s Positive List) in accordance with the common authorisation procedure laid down by the EU.

As will be seen, the transitional scheme and the associated reassessment concern only existing (old) active ingredients (substances on the market before 26 July 1993). Approximately 800 old active ingredients are intended to be reassessed with a view to inclusion in Annex I before the year 2003. As at 1 January 1999, only one old substance has been entered in Annex I to Directive 91/414/EEC. The substance was included by Directive 97/73/EC, which concerns imazalil. (Two new substances, azoxystrobin and kresoximmethyl were included by Directive 98/47/EC and Directive 99/1/EC, respectively).

When an active ingredient is entered in Annex I, plant protection products containing the substance are subject to the rules on authorisation given in Directive 95/57/EC. Also applying are the rules given in Article 10 of Directive 91/414/EEC to the effect that one EU Member State’s authorisation of a product for sale means that the product must basically also be authorised for sale in other EU Member States.

The transitional period will probably have to be extended for some of the old substances since it would hardly be possible to get them all reassessed before the year 2003. See also section 5.1.5 above on the transitional scheme.

In the transitional period, Denmark is relatively at liberty to introduce national regulations. That is because Directive 91/414/EEC contains only a few rules that apply in this transitional period.

In this connection, the sub-committee has considered whether the uniform principles in Directive 97/57/EC (which constitute Annex VI to Directive 91/414/EEC) must be applied in the transitional period. In the view of the sub-committee, Directive 91/414/EEC does not contain an obligation for the Member States to apply the uniform principles in the transitional period. This view is based on the wording of the provisions in Article 4(1) and Article 8(2) and (3) of Directive 91/414/EEC. Furthermore, it appears, per contra, from Article 23 of Directive 91/414/EEC that the uniform principles concern the period after the transitional scheme. The ECJ’s judgment in case C-400/96 of 17 September 1998 seems to point in this direction, since the court does not mention any obligation to apply Directive 97/57/EC in the transitional period.

Lastly, the question has had to be considered of whether the rule in Article 10 concerning mutual recognition applies in relation to provisional (temporary) authorisations issued in pursuance of Article 8(1) and authorisations in pursuance of Articles 8(2) and (3). In the opinion of the sub-committee, that is not the case because, according to the wording of Article 10(2), second bullet, the obligation of mutual recognition does not arise until the active ingredients have been entered in Annex I.

In the following (6.1.1 - 6.1.7) Denmark’s relative freedom of action with respect to regulation is amplified and explained. In this connection it is necessary to distinguish between prohibiting the sale of plant protection products during the transitional period and prohibiting use of plant protection products during the transitional period.

6.1.1 Prohibition of sale of plant protection products

According to Article 8(2), in the transitional period, the Member States may permit the placing on the market of plant protection products containing old active ingredients that are not entered in Annex I. As established in Article 8(3), when the Member States, in accordance with subsection 2, reassess plant protection products containing an active ingredient, they must ensure that the requirements given in Article 4, 1, b) No. i)-v), and in c) to f) are fulfilled in accordance with the national regulations concerning documentation. In addition, in pursuance of Article 8(1), the Member States may permit the placing on the market of plant protection products that contain new active ingredients that have not been entered in Annex I under the conditions mentioned in the article. Since the directive does not impose on the Member States an obligation to permit the placing of plant protection products on the market of in the transitional period, it must be assumed that Directive 91/414/EEC does not prevent Denmark from maintaining or introducing a (total or partial) prohibition of sale during the transitional period.

A total or partial prohibition of the sale of plant protection products in the transitional period has already been introduced in Denmark in the case of some specific products. The so-called Danish Prohibition List, which relates to the Act on Chemical Substances and Products, was thus issued within the framework of the transitional scheme.

The Danish Prohibition List was introduced by Act No. 438 of 1 June 1994 amending Act on Chemical Substances and Products, cf. Section 35c. In this, the following was provided:

The prohibited substances include atrazine and cyanazine⁷³.

As can be seen from the bill’s explanatory notes⁷⁴ on the bill’s relationship with the EU, the sub-committee considers, in view of the given circumstances, that the prohibition of placing on the market (sale) and use laid down in Section 35c is in accordance with Directive 91/414/EEC.

With respect to this bill, it should be noted that the Environmental Protection Agency wrote to the Ministry of Justice on 7 October 1993, asking a number of questions about the draft of Act on Prohibition of Pesticides, which lists certain active ingredients. Among other things, the Environmental Protection Agency asked the Ministry of Justice for an opinion on whether the Commission should be notified about the bill in accordance with the Information Procedure Directive (83/189/EEC) or in accordance with Directive 91/414/EEC on the placing of plant protection products on the market. In a letter dated 11 November 1993, the Ministry of Justice wrote that, in its opinion, the Commission should be notified about the bill in accordance with Article 12 of Directive 91/414/EEC. Referring to Article 12 of Directive 91/414/EEC, the Environmental Protection Agency has notified the Commission about plant protection products withdrawn on the basis of the provisions in Section 35c of the Act on Chemical Substances and Products.

National regulations prohibiting the sale of plant protection products must be in conformity with the EU Treaty, particularly Articles 30-36 thereof, since there may be a case of a restriction of trade. It is thus a requirement that a prohibition of the sale of the individual plant protection products be based on environmental or health grounds or on other grounds that are relevant according to Article 36 of the EU Treaty or the so-called Cassis de Dijon practice.

6.1.2 Prohibition of the use of plant protection products

Directive 91/414/EEC does not contain provisions on the Member States’ right to regulate the use of plant protection products during the transitional period, but only rules on regulating the sale of plant protection products in that period.⁷⁵

On the other hand, any national regulation of use should presumably be assessed in relation to Articles 30-36 of the EU Treaty if the regulation is of such intensity that it has an impact on trade corresponding to a regulation of sale. A total prohibition of the use of plant protection products should thus be assessed in the same way as an import prohibition of plant protection products.

This means that the regulation of use would have to be justified on, for example, environmental grounds, and it would be a requirement that the environmental consideration could not be taken care of in a less radical way, cf. section 5.1.1 above concerning proportionality.

With a considerably less intensive intervention – for example, a prohibition of the use of plant protection products in private gardens or similar – the regulation of use would hardly affect trade and would therefore presumably not be covered by Article 30 of the EU Treaty. Other cases of regulation would have to undergo concrete assessment to determine whether they are of such intensity that they are likely to affect trade and whether, in such case, they are justified in accordance with the proportionality principle. It should be noted in this connection that it is the Member States that have the burden of proving this. Since many plant protection products are authorised for use in other EU Member States, it would be difficult for Denmark to justify a total prohibition.

6.1.3 Use of safety factors and fixing restrictions on use in connection with the authorisation of specific plant protection products

As mentioned in section 6.1 above, the Member States are not obliged to apply Directive 97/95/EC (the uniform principles) during the transitional period. There is thus no obligation on them, either, to use the safety factors laid down in the directive. The Danish authorities may thus use their own and possibly higher safety factors than those given in Directive 97/57/EC in the case of active ingredients that are not listed in Annex I (Positive List). The ECJ’s judgment in Case C-400/96 of 17 September 1998 seems to point in this direction, in that the court does not mention any obligation to use Directive 97/57/EC in the transitional period. Concerning safety factors, see also section 6.8.1.

Directive 91/414/EEC does not provide rules concerning restrictions on use during the transitional period. The directive thus does not prevent Denmark from imposing restrictions on use and areas in the transitional period in connection with the authorisation of plant protection products.

As mentioned above concerning prohibiting the use of plant protection products, national rules on safety factors in connection with the authorisation scheme and conditions concerning restrictions on use laid down in connection with the authorisation of plant protection products would be covered by Articles 30-36 of the EU Treaty.

6.1.4 Labelling regulations

As far as concerns the packaging and labelling of plant protection products, Article 16 of Directive 91/414/EEC states that the packaging of plant protection products must fulfil certain requirements with respect to labelling. It appears particularly from Article 16(5) that the "supplementary labels" mentioned in the provision are subject to a committee procedure. This raises the question of whether Article 16(5) and thus the committee procedure apply in the transitional period with respect to authorisations in accordance with the rules in Article 8(2) and (3).

Since Article 8(3) does not lay down rules on the Member States’ right to regulate use and thus not on their right to regulate the labelling of plant protection products during the transitional period, the sub-committee is of the opinion that the committee procedure laid down in Article 16(5) of Directive 91/414/EEC concerning supplementary regulations does not apply in the transitional period.

6.1.5 WTO law

In so far as the regulation in the transitional period that is mentioned in sections 6.1.1-6.1.4 is in conformity with EU law, the sub-committee is of the opinion that it will also be in conformity with WTO law. The reason for this opinion is that, in order to fulfil the EU requirements, the regulation must be based on a risk assessment and must not be discriminatory – Danish and all foreign plant protection products must be treated equally. With this, the regulation lives up to WTO’s requirements (see section 5.2 above).

6.1.6 Section 73 of the Danish Constitution

Prohibition of the sale or use of plant protection products in the transitional period will not normally trigger compensation in accordance with Section 73 of the Danish Constitution.

For amplification of the relationship between the Danish Constitution and a prohibition of sale and use, readers are referred to section 6.7.3 (and to section 6.2.4).

6.1.7 Conclusion concerning prohibition of sale and use in the transitional period

It is the opinion of the sub-committee that, in the transitional period (that is, as long as the individual active ingredients have not been entered in the EU’s so-called Positive List), Denmark may lay down both general and specific prohibitions on the sale or use of plant protection products that have not yet been entered in the Positive List. However, any rules of the said nature must comply with Articles 30 and 36 of the EU Treaty. This means that such rules must be based on objective environmental or health considerations, that the rules must not extend further than necessary, and that there must be no alternative regulatory instruments that would constitute less of a restriction of trade. The transitional period is set to expire in mid-2003 but must be expected to be extended for several substances if they have not been reassessed by that time.

6.2 Prohibition of sale of specific plant protection products after the transitional period

One crucial question considered by the sub-committee was whether it would be possible for Denmark to prohibit the sale of plant protection products that were authorised for sale in other EU Member States.

To deal with this problem it is necessary to consider thoroughly the content of Directive 91/414/EEC. These considerations lie in extension of the examination of the main content of the directive given in section 5.1.5 above, but are more detailed and specific.

6.2.1 Directive 91/414/EEC covers primarily (authorisation for) sale

The sub-committee has considered which matters are regulated by the directive. The question here is whether the directive contains only direct regulation of matters relating to authorisation of the sale of specific plant protection products or whether it also covers a broader regulation, so that it also covers general restrictions of trade and use.

These questions concern, for example, whether the directive’s rules on authorisation imply that general rules prohibiting the use of plant protection products in particularly sensitive areas may not be laid down.

A closer interpretation of Directive 91/414/EEC is needed in order to clarify the above-mentioned questions. In the following we discuss the clues that can be derived from Directive 91/414/EEC. The section ends with the sub-committee's conclusions on the basis of the said clues.

The directive’s preamble – and in that particularly the 7th whereas clause – indicates that the directive is aimed at introducing a form of regulation that covers only those aspects of sale and use that are associated with the specific authorisation of plant protection products.

The 5th to 8th whereas clauses read as follows:

Article 1, setting out the scope of the directive, reads as follows:

This provision limiting the scope of the directive shows that the directive contains rules concerning all the said areas, i.e. the directive regulates not only authorisation rules but also certain matters relating to sale and use. However, since the provision does not contain a detailed indication of the content of the said areas, it cannot be used as a basis for a thorough assessment of the extent to which the directive regulates matters relating to sale and use.

In the directive’s general provisions it is stated in Article 3(1) that plant protection products may only be placed on the market and used provided they are officially authorised in accordance with the directive’s rules. This provision indicates that the directive regulates only sale and use relating to the specific products and fixed in connection with authorisation of the products.

The directive does not contain any general free trade clause. In Directive 91/414/EEC, consideration for free trade is expressed in Article 10 concerning the obligation of mutual recognition of authorisations. On the other hand, there is no obligation for the Member States to authorise plant protection products independently in accordance with the provisions of Article 4. This aspect is discussed in greater detail below in the section on the harmonising nature of the regulation (section 6.2.2).

The directive does, however, contain two more specific free trade clauses: 1) Article 3(2), which states that, in defined circumstances, Member States shall not, on the grounds that a plant protection product is not authorized for use in their territory, impede the production, storage or movement of such products intended for use in another Member State (in other words, the rule concerns only transit situations) and 2) Article 4(1)f, which states that, in given circumstances, Member States may not impede the introduction into their territory of products containing pesticide residues.

Conversely, the free trade clauses in question indicate that, in the other areas, the directive regulates only those aspects of sale and use that relate to the authorisation of specific plant protection products.

Basically, the directive contains two sets of rules concerning authorisation of plant protection products: namely, Article 4 on granting, control and withdrawal of authorisation of plant protection products and Article 10 on mutual recognition of authorisations. From the wording of the said provisions it can be deduced that the directive regulates only those aspects of sale and use that relate naturally to the specific authorisation of individual plant protection products.

As far as concerns use of plant protection products, the directive contains a number of rules on this. Readers are referred to Article 4(2), which states that an authorisation of a plant protection product must stipulate requirements concerning its use, and to Article 10, the wording of which indicates that mutual recognition of an authorisation implies that the requirements already stipulated concerning use must be recognised as part of the authorisation. It can thus be deduced that the directive regulates only rules on use that are fixed in connection with the granting of specific authorisations.

Furthermore, Article 16(3) contains a labelling rule concerning the use of plant protection products by certain categories of users. This rule concerns labelling in connection with any national rules on use that might be laid down in accordance with Directive 91/414/EEC. Since Article 16(3) covers only matters relating to labelling, it can be deduced that the rule does not in itself contain any indication of the extent to which Directive 91/414/EEC regulates rules on use.

Lastly, it should be noted that Article 16(5) of the directive states that the Member States – when laying down supplementary labelling requirements concerning, for example, conditions of use – shall follow the stated committee procedure. Unlike the provisions on conditions of use given in Articles 4 and 10, the wording of Article 16(5) does not give any indication of whether Article 16(5) covers the labelling rules fixed in connection with the granting of specific authorisations or generally fixed rules on use. In view of the relationship with the other structure of the directive concerning regulation of authorisations, it can be argued that Article 16(5) covers only labelling rules laid down in connection with the granting of specific authorisations. However, the wording of the provision does not provide grounds for taking Article 16(5) to mean that it covers only requirements in connection with specific authorisations. With reference to the last-mentioned argument, it is the sub-committee’s opinion that the procedure in Article 16(5) covers both generally and specifically fixed requirements concerning specification of conditions of use.

Readers are also referred to the Commission’s proposal for "Decision on an action programme for integrated protection and administration of groundwater." (COM(96)315 final version). In this it is proposed, among other things, that the Member States introduce protection zones and restrictions on the use of plant protection products, depending on the circumstances. For this reason, it must be assumed that Directive 91/414/EEC does not exclude the establishment of national, general restrictions on sale and use.

It should be noted that Act No. 479 of 1 July 1998 amending the Act on Water Supply etc., Act on Environmental Protection and Act on Planning includes an amendment of Section 26a of the Environmental Protection Act. The amendment has created the authority for county or local authorities to implement compulsory restrictions on the right of disposal and other measures needed to safeguard present or future drinking water interests against pollution with nitrate or pesticides if an action plan for the area has been adopted in accordance with the Water Supply Act and if it is not possible to achieve the same aim with voluntary measures.

Lastly, in "The European Community Programme of Policy and Action in relation to the Environment and Sustainable Development" (The Commission’s 5th Action Programme of 30 June 1992), objectives were established up to the year 2000. The objectives within the agricultural sector included: "Substantial reduction of pesticide use per cultivated unit of area and farmers switching to integrated pest control methods, at any rate in natural areas that are worthy of preservation".

On the basis of the above contributions to interpretation and considerations, the sub-committee is of the opinion that Directive 91/414/EEC includes regulation of the following matters:

6.2.2 Nature of the harmonisation

With a view to assessing the extent to which the rules in Directive 91/414/EEC on authorisation for sale etc. bind Danish legislation, it is necessary to consider the harmonising nature of the regulation contained in the directive.

The directive is based on Article 43 of the EU Treaty, which means that the Member States cannot use Article 100a(4) – the so-called environmental guarantee – for regulating plant protection products. It follows from this that it must be determined whether the scope of Directive 91/414/EEC is an expression of total harmonisation – in other words, whether it contains exhaustive regulation. If this is so, the directive’s rules may only be deviated from to the extent that the directive provides authority for this.

A discussion follows of the contributions to interpretation of the harmonising nature of the regulation that can be derived from Directive 91/414/EEC. The section ends with a summary of the sub-committee’s conclusions.

As mentioned, the legal basis for Directive 91/414/EEC is Article 43. However, seen in isolation, the legal basis does not determine the harmonising nature of the directive because this depends on a complete interpretation of the directive, namely, the wording of the directive’s provisions.

The preamble in Directive 91/414/EEC does not contain an unambiguous statement concerning the harmonising nature of the directive. The words "harmonising" (6th whereas clause) and "uniform rules" (7th whereas clause) indicate that, in the areas in question, the directive contains provisions that are an expression of total harmonisation.

Seen in isolation, Article 4 concerning the authorisation scheme seems from its wording to be a minimum provision that ensures that unsafe plant protection products are not authorised. Article 4 thus does not have any free trade provision attached to it, giving the applicant the right to authorisation.

On the other hand, the free trade consideration is taken care of by Article 10, which gives an applicant that has already obtained authorisation in one Member State the right to recognition of this authorisation in other Member States provided the applicant proves to the individual Member States that the conditions for mutual recognition are fulfilled.

Directive 91/414/EEC contains concrete provisions that establish explicitly that the Member States may impose supplementary restrictions in connection with the authorisation of plant protection products, cf., for example, Article 10. From the provisions that explicitly give the Member States the possibility of laying down supplementary provisions in specific areas, it can, per contra, be deduced in principle that, in the other area of the directive, the Member States do not have the possibility of laying down supplementary provisions. Against this, however, it can be deduced that the other area outside Article 10 is essentially the area that concerns authorisations in accordance with Article 4. With the wording of Article 4(2) it is hardly possible to conclude per contra from Article 10.

Lastly, it appears from Directive 97/57/EC, point B.1, No. 2, that "in all cases where it is possible to do so, the Member States shall also take into account the principles of integrated control". Point C.1, No. 4, states that "Member States shall ensure that decisions respect the principles of integrated control if the product is intended to be used in conditions in which these principles are relied on".

The concepts "integrated control" and "integrated prevention and control" can be regarded as legal standards. It is the sub-committee’s opinion that these standards actually give the individual Member State a certain freedom of action, so that authorisation can be refused in certain cases, under reference to the provision on integrated prevention and control. (This is enlarged upon in section 6.9 below).

On the basis of the foregoing, the sub-committee’s conclusion concerning the harmonising nature of the directive’s regulation can be summarised as follows:

Concerning first-time authorisation of the placing on the market of specific plant protection products (Article 4), the sub-committee considers that it is relatively unclear whether the provision in Article 4 implies a minimum harmonisation that means, in principle, that the Member States are not obliged to authorise a plant protection product that fulfils the conditions mentioned in Article 4. The wording of Article 4 indicates a minimum harmonisation. Conversely, the consequence of a minimum harmonisation is that the Member States may lay down requirements concerning plant protection products (product requirements) that are stricter than those given in the directive and that the Member States may refuse to grant authorisation even though the conditions mentioned in the directive are fulfilled.

This consequence does not harmonise particularly well with the directive’s other provisions on mutual recognition. In the sub-committee’s opinion, Directive 91/414/EEC does not lay down exhaustive, substantive requirements concerning the plant protection products that a Member State can authorise in accordance with Article 4. However, this is of limited importance because of the provisions in Article 10 concerning the obligation of mutual recognition of other Member States’ authorisations of plant protection products. In addition, Directive 97/57/EC limits the discretion that may be exercised by the Member States in their handling of applications in pursuance of Article 4. In other words, within the framework set in Directive 97/57/EC, the Member States may refuse authorisation of a plant protection product and thus prohibit its sale.

The sub-committee concludes that, with its wording, the provision in Article 10 contains a total harmonisation that implies that the Member States are obliged to authorise a plant protection product if the product has been authorised by another Member State and the applicant has proved that the conditions for mutual recognition have been fulfilled. Furthermore, the total harmonisation provision means that the Member States may only lay down rules on use in connection with mutual recognition within the framework laid down in the provisions concerning mutual recognition. (As modification of this, see, however, section 6.9 below on integrated prevention and control).

6.2.3 WTO rules affecting sales prohibitions

In relation to WTO law, a total or partial prohibition of import of plant protection products should basically be regarded as a quantitative restriction at variance with GATT, Article XI.

To the extent that the EU has laid down harmonised rules for authorisation of plant protection products, a Danish prohibition of imports from third countries could be regarded as internal discrimination within a part of the EU (Denmark) at variance with the EU’s obligations under GATT Article III (the NT principle).

A total or partial prohibition could, however, be implemented if it was covered by the exemptions in GATT Article XX and thus went no further than needed to fulfil one of the objectives mentioned there.

If the purpose of the prohibition is to protect human or animal health against the risks from pesticide residues in food products, beverages or feed, the prohibition should be assessed on the basis of the SPS Agreement.

If the scientific evidence is deemed insufficient for a suitable risk assessment, a prohibition can be assessed on the basis of Article 5(7) of the SPS Agreement. Use of this exemption is restricted by the fact that additional information needed for a more objective risk assessment must be sought with a view to assessing the prohibition in the light thereof within a reasonable time limit.

If there is sufficient scientific evidence for a suitable risk assessment, this must be carried out in accordance with the rules given in Article 5(1) to (3) of the SPS Agreement. This risk assessment can be based on both scientific and other relevant factors, cf. Article 5(2) and (3). Depending on the circumstances, importance can be attached in that connection to the possibility of misuse⁷⁶ of the relevant plant protection products and the risks involved in that. In the specific case it must be judged whether there is a necessary, rational relationship between the result of the risk assessment and the prohibition.

If a prohibition cannot be imposed as a consequence of Directive 91/414/EEC, it seems most obvious to assume that a unilateral Danish prohibition of import from countries outside the EU – while import from EU countries is allowed – must be regarded as unwarranted discrimination of WTO Members outside the EU at variance with Article 2(3).

A Danish prohibition that is at variance with the EU’s rules must thus be assumed to constitute a breach of the SPS Agreement unless there are special actual factors that show that a unilateral prohibition of import of plant protection products from third countries – but not from EU Member States – does not constitute discrimination or disguised restriction of international trade.⁷⁷

If the purpose of the prohibition is not to protect human and animal life or health against risks from additives, pollutants, toxins or pathogenic organisms in food products, beverages or feed, the prohibition will be covered by the TBT Agreement, in that there is thereby assumed to be a technical regulation in the form of requirements concerning plant protection products or their method of production.

It is the opinion of the sub-committee that WTO law generally provides the same – limited – possibilities of a national prohibition of the sale of plant protection products imported from third countries as the possibilities of prohibiting the sale of plant protection products from the EU area.

6.2.4 Section 73 of the Danish Constitution

The restrictions that follow from section 73 of the Danish Constitution are described in connection with a prohibition of use. Readers are therefore referred to the section on this (section 6.7.3). The sub-committee is of the opinion that a sales prohibition would not give rise to problems with Section 73 of the Danish Constitution.

6.2.5 Conclusion concerning prohibition of the sale of plant protection products authorised for sale in another Member State

This and the following section give the sub-committee’s conclusions from the considerations given above in sections 6.2.1 to 6.2.4.

A vital question for the sub-committee is whether Denmark can refuse to authorise the placing on the market in Denmark of a plant protection product that has been authorised for sale in another EU Member State.

When the transitional period comes to an end (mid-2003)⁷⁸, Denmark will only exceptionally – and only within certain limits – be able to refuse to authorise a specific plant protection product for sale here in Denmark if it has been approved in accordance with the uniform principles in another EU Member State. That follows from Article 10 of Directive 91/414/EEC, which is an absolutely core provision.

The fundamental aim of Article 10 of Directive 91/414/EEC is to ensure that a manufacturer of a plant protection product who has obtained authorisation for sale of the product in one Member State can relatively easily, and without entirely new tests, obtain authorisation for its sale in other Member States.

Denmark thus has an obligation to authorise a plant protection product for sale in Denmark if another Member State has authorised it and the applicant has specifically proved that the conditions for mutual recognition are fulfilled (obligation of mutual recognition).

Denmark can, however – although only within certain limits – refuse authorisation. According to Article 10(1), it can, in particular, do so if it can be proved that there are other conditions in Denmark (lack of comparability) concerning the agricultural, phytosanitary and environmental conditions, including climatic conditions, in which the product is used. In other words, authorisation can only be refused on objective grounds of some weight.

For example, the precipitation and soil conditions in Denmark may be of such a nature compared with the corresponding conditions in the country of original authorisation that the product leaches to the groundwater in concentrations that exceed the limit value.

If Denmark refuses to authorise a plant protection product that has been authorised by another Member State, the Commission must be notified and a committee procedure must be carried out.

If the conditions that constitute the difference between Denmark and the original country of authorisation can be counteracted by less radical means – for example, by prohibiting spraying in the autumn months, then there are no grounds for prohibiting the sale of the plant protection product, but only grounds for setting (such) national requirements concerning use of the product.

All in all, the requirement concerning mutual recognition (Article 10) sets narrow limits for Denmark’s freedom of action in cases in which a plant protection product has been authorised for sale in another Member State.

6.2.6 Conclusion concerning prohibition of sale of plant protection products in connection with first-time authorisations

Denmark has more freedom of action if application is made for authorisation of a plant protection product in Denmark without the product first having been authorised in another EU Member State or if mutual recognition is not claimed (first-time authorisation).

Basically, there is no obligation to notify a first-time authorisation. There is no provision on such an obligation in Directive 91/414/EEC (unlike cases in which there is an authorisation from another Member State – here, Article 10 implies an obligation of mutual recognition).

However, in the case of first-time authorisations, Denmark must respect the uniform principles laid down in Directive 97/57/EC. The authorising authorities have a duty to be loyal to the principles. However, these principles, which are of a technical nature, contain some flexibility, since many sub-estimates must be carried out when assessing the results of tests etc. There must naturally be good, objective grounds for refusing authorisation.

No committee procedure is required when refusing first-time authorisation (unlike the case of refusal to authorise a plant protection product that has been authorised in another Member State), but an affected company can complain to the EU Commission, and the Commission can institute proceedings at the ECJ.

If Denmark refuses to grant first-time authorisation, and the manufacturer in question then applies for, and obtains, authorisation in another Member State, then – after renewed application, Denmark is obliged to authorise the plant protection product in question (mutual recognition in accordance with Article 10) if the conditions laid down in Article 10 are fulfilled.

All in all, Denmark has some freedom of action with respect to first-time authorisations, but this can be limited if a manufacturer who has been refused authorisation in Denmark, is granted authorisation in another Member State.

6.3 Prohibition of sale of plant protection products - general

Directive 91/414/EEC regulates only questions concerning specific authorisations of specific plant protection products with a view to sale, including the requirement concerning mutual recognition of specific authorisations in other EU Member States.

The directive thus does not regulate the question of an entirely general prohibition of the sale of plant protection products as such in the individual Member State.

The directive thus does not prevent a general, national, Danish prohibition of the sale of plant protection products, with the exception of transit and pesticide residues, cf. Article 3(2) and Article 4(1)f, since these provisions must be regarded as exhaustive.

However, it could be argued that such a general prohibition was a form of evasion and should thus be assessed in relation to Directive 91/414/EEC. The reason for this is that a general prohibition of the sale of plant protection products would mean that plant protection products authorised for sale in other EU Member States could not be sold here in Denmark.

Under all circumstances it must be assumed that a general prohibition is only acceptable if, in respect of every single plant protection product that has been authorised in another Member State, it can be proven that there are special conditions here in Denmark – for example, agricultural, environmental or climatic conditions – that warrant a total prohibition.

All in all, a general prohibition of the sale of plant protection products in Denmark would thus be a purely theoretical possibility, since it would be difficult to implement such a prohibition in practice, even though Directive 91/414/EEC does not say anything directly about such a prohibition.

Furthermore, a total prohibition only of sale in Denmark would not in itself prevent farmers from buying and importing plant protection products from other EU Member States that have authorised their sale.

6.4 Authorisation for sale on conditions that restrict the use

In section 6.3 the question is considered of whether a general prohibition of the sale of plant protection products in Denmark would be possible after the transitional period.

As will be seen, the possibilities of such a sales prohibition are limited, particularly in the case of plant protection products that have been authorised in another EU Member State.

In this section we shall consider whether the individual EU Member State – to the extent that it cannot prohibit the sale of a plant protection product – can actually, in connection with the authorisation of the product, lay down conditions that restrict the possibility of using it.

The question is whether, in connection with authorisation of an individual, specific plant protection product, conditions can be laid down that restrict use of the product in question to specific crops, to control specific pests, and to specific times of the year etc., and whether use of the product can be restricted in specific areas, e.g. in particularly sensitive areas.

The question is considered partly in relation to the EU rules and partly in relation to WTO law.

6.4.1 EU rules

As will be seen from section 6.2.1 above, Directive 91/414/EEC covers primarily the actual authorisation of an actual plant protection product for sale. In connection with such authorisation there are certain possibilities of setting conditions.

Considered first here is the question of conditions in cases in which application is made for authorisation of a plant protection product in Denmark before it is authorised in other EU Member States or in which the applicant is not invoking mutual recognition in accordance with Article 10 of the directive.

Article 4 of Directive 91/414/EEC, points C.1.1 and C.1.2 of Directive 97/57/EC and Directive 97/73/EC imply that, within certain limits, the Member States may impose national restrictions on use and areas in connection with authorisation of plant protection products in accordance with Article 4 of Directive 91/414/EEC.

It appears explicitly from Article 4(2) of Directive 91/414/EEC that the Member States must stipulate requirements concerning use in connection with authorisation for the placing of plant protection products on the market. For example, Article 4(1), b), v) – to which Article 4(2) refers – stipulates that the Member States must lay down restrictions on use that will ensure that use of the products does not have any unacceptable effect on the environment.

Similarly, it appears explicitly from the provisions in points C.1.1 and C.1.2 of Directive 97/57/EC, which concern the decision-making process in connection with national authorities’ handling of applications for authorisation of plant protection products, that national authorities, when granting authorisation, may stipulate restrictions on use, including area restrictions.

The actual formulation of such restrictions on use and area restrictions must be in accordance with the rules laid down in the directives, including points C.1.1 and C.1.2 of Directive 97/57/EC. In this connection, it must, in the opinion of the sub-committee, be assumed that specific restrictions on use and area that are objectively justified, relevant, in proportion to the intended objectives and non-discriminatory, are in accordance with the framework provided in the directives.

In the case, for example, of Directive 97/73/EC (concerning inclusion of imazalil on the Positive List), it is thus the sub-committee’s opinion that the special conditions laid down in the Annex concerning use must be interpreted as minimum conditions. The sub-committee is of the opinion that the conditions laid down in the Annex concern inclusion of the active ingredient in Annex I (the Positive List), but that this does not change the rules laid down in points C.1.1 and C.1.2 of Directive 97/57/EC concerning the right to lay down further restrictions on use and area in connection with the authorisation of the products.

With respect to the laying down of restrictions on use and area, it should be noted that related labelling requirements are covered by the provision in Article 16(5) of Directive 91/414/EEC and are thus subject to the rule concerning a committee procedure if the requirements are in the nature of "supplementary phrases." (See section 6.5 below.)

The sub-committee is of the opinion that restrictions on use and area that are laid down in accordance with the above-mentioned provisions in the directives shall not be assessed in relation to Articles 30-36 of the EU Treaty, since regulations laid down in pursuance of Directive 91/414/EEC are assumed to be in accordance with these Treaty provisions.

It is stated in Article 10(1)1 of Directive 91/414/EEC that a Member State that receives an application for authorisation of a plant protection product that is already authorised in another Member State must as a general rule recognise the authorisation already issued and thus authorise the placing of that product on the market in its territory.

With reference to the wording of Article 10, it can be stated that the obligation laid down in Article 10(1)1 for a Member State to authorise the placing of a plant protection product on the market in its territory must be taken to mean authorisation with exactly the same requirements concerning use and area as far as concerns the agricultural, plant health and environmental conditions, including climatic conditions (provided these are comparable).

With respect to mutual recognition of authorisations in accordance with Article 10 of Directive 91/414/EEC, the sub-committee is of the opinion that Article 10(1)2, 3 and 4, combined with subsections 2 and 3, means that certain restrictions on use and area can be laid down nationally for reasons of dealer, user and employee health or for nutritional reasons without the applicant’s consent and without a subsequent committee procedure.

It appears explicitly from the provisions in Article 10(1), 2 and 3, that certain conditions of use can be attached to an authorisation on grounds of dealer, user and employee health or for nutritional reasons.

Directive 89/391/EEC on the initiation of measures to improve employees’ health and safety at work is not seen as containing independent authority that extends beyond the directive on plant protection products to enabling or requiring the authorities to lay down conditions for use of plant protection products in connection with authorisation of the products. See also section 6.8.2 on the setting of the so-called AOEL values, which indicate the level of exposure to plant protection products that is acceptable for the users/employees.

Article 10(1)2 covers the health of dealers, users and employees but not the health of the consumers. The health of the consumers, on the other hand, is covered by Article 10(1)3, which concerns nutritional considerations (see also sections 5.1.1.4 and 6.10 on pesticide residues in food products).

Referring to the wording of Article 10(1)2 and 3, these provisions must imply that a Member State that receives an application for authorisation of a plant protection product that is already authorised in another Member State can, when authorising the product, lay down restrictions on its use, including restrictions on area, that change or supplement any restrictions that may already have been laid down in connection with the authorisation of the product in the other Member State. However, such restrictions on use and area must basically lie within the framework established in Article 10(1)2 and 3.

With reference to the wording of Article 10(1)4, the assumption concerning the applicant’s consent to changes in the conditions of use that are attached to the authorisation apply only to conditions of use concerning the conditions mentioned in Article 10(1)4, namely, the agricultural, plant health and environmental conditions, including climatic conditions. Conversely, it can thus be held that consent by the applicant is not a condition for a change in the conditions of use that is warranted by other conditions than those mentioned in Article 10(1)4. Other conditions can thus be the health of dealers, users and employees or nutritional considerations.

With reference to the wording of Article 10(2) and (3), it can be held that the obligation thereby laid down to notify the Commission and the obligation to follow the procedure in Article 19 apply in those cases in which the Member State 1) has required the repetition of a test, 2) has refused to authorise a plant protection product that has already been authorised in another Member State, and in connection with which the applicant has claimed comparability with respect to the agricultural, plant health and environmental conditions, including climatic conditions, or 3) wishes to change the conditions of use or area without the applicant’s consent on grounds of the agricultural, plant health or environmental conditions, including climatic conditions.

Conversely, it can thus be held that when a Member State lays down different or supplementary conditions of use and area on grounds of the health of dealers, users and employees or nutritional considerations in accordance with Article 10(1)2 and 3, the Member State does not have to notify the Commission of that or follow the procedure laid down in Article 19. From the wording of Article 10(3), it does not seem certain that that is the case since the committee procedure is only mentioned where comparability is not recognised.

With respect to the laying down of restrictions on use and area, it should be noted that related labelling requirements are covered by the provision in Article 16(5) of Directive 91/414/EEC and are thus subject to the committee procedure if "supplementary phrases" are required.

It is the opinion of the sub-committee that restrictions on use and area that are laid down in accordance with the above-mentioned provisions in the directives shall not be assessed in relation to Articles 30-36 of the EU Treaty because a regulation provided in pursuance of Directive 91/414/EEC is assumed to be in accordance with these Treaty provisions.

The sub-committee is of the opinion that Article 10(1)4, combined with subsections 2 and 3 mean that restrictions on use and area on grounds of agricultural, plant health and environmental conditions, including climatic conditions, can be laid down with the applicant’s consent or in connection with a subsequent committee procedure.

Article 10(1)1 imposes on a Member State an obligation to authorise plant protection products that are already authorised in another Member State provided the agricultural, plant health and environmental conditions, including climatic conditions, are comparable.

With respect to the obligation of authorisation mentioned in Article 10(1)1, it can, however, be held that at any rate two modifications apply as far as concerns restrictions on use and area laid down on grounds of agricultural, plant health and environmental conditions, including climatic conditions. These modifications follow from the wording of Article 10(1)4 and Article 10(2) and (3), respectively.

Article 10(1)4 implies that, with the consent of the applicant, a Member State can change already laid down conditions of use in order, for reasons of comparability, to reduce the importance of, inter alia, the environmental conditions.

It also appears from Article 10(2) and (3) that a Member State may change already laid down restrictions on use and area without the applicant’s consent provided the Member State subsequently notifies the Commission about this and then follows the procedure in Article 19.

On the basis of the above-mentioned considerations it can be held that, procedurally, Article 10(1)4 and Article 10(2) and (3) imply that an environmentally determined change in already issued conditions of use and area depends either on the applicant accepting the changed conditions or on the Member State notifying the Commission about the changed conditions and on these not then being disallowed by a decision taken in accordance with the procedure laid down in Article 19.

Furthermore, on the basis of the above-mentioned considerations, it can be held that the wording of Article 10(1)4 and Article 10(2) and (3) basically implies that the conditions of use and area must, for example, be formulated with a view to reducing the importance of lack of comparability.

With respect to the national authorities’ assessment of whether the agricultural, plant health and environmental conditions, including climatic conditions, are comparable – including the question of which conditions of use can neutralise the importance of lack of comparability – it should be noted that there are no precise rules at present for how this assessment is to be made.

With respect to the stipulation of conditions of use and area, it should be noted that related labelling requirements are covered by the provision in Article 16(5) of Directive 91/414/EEC and are thus subject to a committee procedure if there is a case of stipulating "supplementary phrases".

In the sub-committee’s opinion, restrictions on use and area that are laid down in accordance with the above-mentioned provisions in the directives do not have to be assessed in relation to Articles 30-36 of the EU Treaty, since a regulation laid down in pursuance of Directive 91/414/EEC is assumed to be in accordance with these Treaty provisions.

In the case of some of the pesticides authorised in Denmark, the product’s label and the instructions for use include conditions to the effect, for example, that the product in question may only be used once a year and, in such case, before 1 August, or that the product may only be used in the spring. At the present time, such conditions are laid down in accordance with the directive’s rules concerning the transitional period. After the transitional period, such conditions must, where called for, be issued with reference to the rules in Article 4, including the rules in Directive 97/57/EC, cf. above concerning first-time authorisations.

The sub-committee has come to the conclusion that, within the formal and substantial rules set out below, Denmark can impose restrictions on use and area in connection with first-time authorisation of plant protection products and in connection with mutual recognition of authorisations issued in other Member States.

In the case of first-time authorisation of plant protection products and mutual recognition of authorisations issued in other Member States, it is a condition that the restrictions on use and area are objectively based, relevant, in proportion to the intended objective and non-discriminatory.

In the case of mutual recognition of authorisations issued in other Member States, it is also a condition that restrictions on use and area imposed on grounds of dealer, user and employee health or for nutritional reasons comply with the provisions of Article 10(1)2 and 3.

In the case of mutual recognition, it is also a condition that restrictions on use and area imposed for reasons of agricultural, plant health and environmental conditions, including climatic conditions, are formulated with a view to reducing the importance of incomparability.

In certain cases it is also a condition that restrictions on use and area are subsequently accepted by the Commission or the Council in accordance with the procedure laid down in Article 19.

When restrictions on use and area are imposed in connection with both authorisations of plant protection products and mutual recognition of authorisations issued in other Member States, it is a condition that such restrictions, together with the "supplementary phrase requirements" covered by Article 16(5) are accepted by the Commission or the Council in accordance with the procedure laid down in Article 19.

6.4.2 WTO rules

Where restrictions on use and area are imposed with a view to protecting humans and animals against the risks from pesticide residues in food products, beverages or feedstuffs, the restrictions must be assessed on the basis of the SPS Agreement.⁷⁹

If the level of protection thereby established is not based on international standards or if such standards do not exist, the measures must fulfil the requirements given in Article 5 of the SPS Agreement.

If the scientific basis is sufficient for a suitable risk assessment, such an assessment shall be carried out in accordance with the rules in Article 5(1) to (3) of the SPS Agreement, as mentioned in section 4. It must basically be expected that a suitable risk assessment can be carried out so that the restrictions on use and area can be implemented in accordance with Article 5(1) of the SPS Agreement.

If the restrictions cannot be implemented as a consequence of Directive 91/414/EEC, it seems obvious to assume that more stringent restrictions in connection with the authorisation of plant protection products from third countries⁸⁰ imported from WTO Members outside the EU must be regarded as unwarranted discrimination in violation of Article 2(3).⁸¹

6.4.3 Conclusion concerning conditions for authorisation for sale

To summarise, the sub-committee concludes that, in connection with the authorisation of the placing on the market of a specific plant protection product here in Denmark, certain conditions may be laid down restricting the right to use the product in certain areas and on certain crops etc.

However, the right to lay down such conditions is limited if the plant protection product has been authorised for sale in another EU Member State.

6.5 Sales restrictions in the form of requirements concerning labelling on packaging

The individual Member State may require additional phrases to be marked on the packaging of the individual, authorised plant protection product, cf. Article 16 of Directive 91/414/EEC.

The limitations on authorities’ right to require phrases follow from Article 16(5) of Directive 91/414/EEC, which reads as follows:

As will be seen from the provisions, phrases required by the said authorities are subject to a committee procedure. The individual Member State can thus not, by this means, independently impose sales restrictions.

6.6 General conditions concerning placing on the market

As will be seen from sections 6.1-6.3 above, Denmark’s possibilities of prohibiting the sale of plant protection products that have been authorised in other Member States are very limited.

In this section, we shall look at the extent to which the individual Member State can instead regulate the actual procedure in connection with the sale of plant protection products. If the procedure could be regulated, there would be a possibility of restricting use of those plant protection products that cannot be kept out of the market by prohibiting their sale.

One can differentiate between product requirements and marketing requirements. Product requirements relate to the products plant protection products themselves. These product requirements could, for example, include requirements concerning the appearance, composition, labelling and packaging of a product. Marketing requirements, on the other hand, are requirements concerning, for example, authorisation of vendors, sales outlets and advertising – including prohibition of advertisements.

Directive 91/414/EEC must be presumed to regulate product requirements, but not marketing conditions.⁸² In the sub-committee’s opinion, this at any rate applies to broad marketing conditions laid down in the form of general rules in laws and executive orders. The directive thus does not prevent the individual Member State from laying down broad market conditions.

The question is then whether such marketing conditions imply a disregard of Article 30 of the EU Treaty (technical trade barriers). This is an obvious assumption. However, it appears from an ECJ judgment that rules on marketing – provided they are not discriminatory – in practice fall outside the scope of Article 30.

In areas that are not regulated by directives, the ECJ has distinguished between requirements concerning the product itself and requirements concerning sales and marketing conditions in the broad sense, cf. the joined cases C-267/91 and C-268/91 (Keck and Mithuard). In this judgment, the court states that, in its opinion, product-related requirements (product requirements), even though applying to both domestic and imported products, must be presumed to imply that imported products are prevented from gaining access to the market or to cause greater difficulties for imported products than for domestic products. There is not, on the other hand, a similar prior assumption with respect to marketing rules in the broad sense if the national rules apply to all the affected businesses operating in Denmark and, both legally and de facto, affect the sale of both imported products and domestic products in the same way.

In the sub-committee’s opinion, Directive 91/414/EEC regulates national product requirements but not marketing conditions. The sub-committee is also of the opinion that a national marketing rule should not in practice have to be assessed in relation to Article 30 of the EU Treaty.

The foregoing concerns the EU rules. However, the WTO rules do not appear to add requirements beyond the EU rules. In other words, it must be assumed that it is possible to make the same, broad marketing requirements concerning plant protection products imported from third countries as are made concerning products imported from EU Member States.

Denmark thus has some freedom of action with respect to general regulation of the procedure in connection with the marketing of plant protection products. For example, it could be stipulated nationally that plant protection products were only to be sold by corn and agricultural merchants, whose main customers are farmers and that the products were only to be sold to persons with particular qualifications.

6.7 General prohibition (total or partial) of the use of plant protection products

6.7.1 EU rules

Scope of the directive

As already mentioned, Directive 91/414/EEC primarily regulates specific authorisation of specific plant protection products with a view to sale. With respect to rules on use, this means that the directive covers only rules on use that are laid down in connection with the specific authorisation of the individual plant protection product – for example, rules to the effect that the plant protection product in question may only be used in the spring or may only be used for dressing seed.

Directive 91/414/EEC does not, on the other hand, cover general prohibitions of use, for example, a rule given in an act or executive order (or laid down with authority therein) prohibiting the use of plant protection products in designated areas.⁸³

Even though Directive 91/414/EEC thus does not directly cover general prohibitions of use, the individual Member State is not at liberty to lay down such (total or partial) prohibitions. A prohibition must be judged in relation to Articles 30 and 36 of the EU Treaty, in that it must not be in the nature of an unwarranted technical trade barrier (see section 5.1.1 above concerning Articles 30 and 36 of the EU Treaty).

This means, cf. Article 36 of the EU Treaty and the ECJ’s so-called Cassis de Dijon practice that the regulation of use (prohibition) must be justified on, for example, environmental or health grounds, and it must be assumed that the objective in question cannot be achieved in a less radical way.

It is the Member State in question that has the burden of proving that the regulation is acceptable from a proportionality point of view.

If a general prohibition of use affects the use of plant protection products that are authorised for sale in other EU Member States in accordance with the uniform principles for this (laid down in Directive 97/57/EC), stricter requirements must be expected concerning the grounds for the prohibition of use. This applies particularly if the reasons for the Danish (total or partial) prohibition have been taken into consideration by other Member States as actual rules on use in connection with the authorisation for sale in these other Member States. Such stricter requirements concerning grounds mean that Denmark would have to cite very weighty grounds for the said total or partial prohibition of use.

The proportionality consideration means, moreover, that the larger the quantities of plant protection products that are affected by a total or partial prohibition of use, the weightier the environmental or health grounds for the prohibition must be.

A prohibition of use laid down, for example, for product groups, could be of such a product-specific nature that it would be regarded as an evasion of the rules on authorisation given in Directive 91/414/EEC. In such case, the prohibition could only be accepted if it fulfilled the conditions laid down Article 10 of Directive 91/414/EEC for refusing authorisation for sale.

A general rule on use can consist in stipulating that plant protection products as a whole or certain groups of plant protection products – for example, herbicides – must not be used between, for example, 1 September and 1 March. The environmental grounds could in such case be that, owing to large quantities of precipitation in that period of the year, there is a greatly increased risk of leaching of the products in question to the groundwater. (See also section 6.4.1(b) above on conditions concerning use in specific seasons in connection with authorisation for sale.)

6.7.2 WTO rules

On the basis of the general exposition in section 5.2 above concerning the WTO rules and in section 6.2.3 concerning the importance of the WTO rules for prohibition of sale, it can be assumed that if a prohibition of use can be accepted under the EU rules, it will also be acceptable under WTO rules.

6.7.3 Section 73 of the Danish Constitution

A prohibition of the use of plant protection products in the agricultural industries also raises a question concerning the relationship with section 73 of the Danish Constitution concerning the Right to Property, Expropriation.⁸⁴

Section 5.3 above contains a general discussion of section 73 of the Danish Constitution, including the criteria that determine whether an Act is of an expropriative nature and thus gives rise to a claim for compensation in accordance with section 73 of the Constitution.

On the basis of these criteria, we assess in this section whether a total or partial prohibition of the use of plant protection products by farmers triggers compensation under section 73 of the Constitution.

In the situation in question, the transfer criterion does not indicate expropriation. Although a statutory regulation that includes a total prohibition of the use by all farmers of plant protection products would probably restrict the farmers’ to organise their farming operation as they wish, but would not thereby result in any transfer of such free right of use to other beneficiaries.

The cause criterion does not indicate a case of expropriation, either, since the intervention is based on a desire to reduce the harm to health and the environment that can be associated with farming, where plant protection products are used.

In the case of the intensity criterion, whether the intervention is in the nature of expropriation depends on a concrete evaluation of the intensity of the intervention. It is usually assumed that the intensity criterion, in isolation, can only take an intervention outside the expropriation rules if the intervention is of very slight intensity. Conversely, it would be a very clear indication of expropriation if the intensity of the intervention were so great that there was in reality a case of deprivation of property. However, the case in question lies between the two extremes mentioned. Carried to its logical conclusion, one could admittedly envisage the prohibition of the use of plant protection products having such an impact that farmers as a whole would lose the basis for their existence. However, the restructuring for organic production without the use of plant protection products that has taken place voluntarily in recent years shows that operation without such products is both practicable and financially feasible. The intensity criterion must accordingly be evaluated in connection with the general-specific criterion, cf. below.

The introduction of legislation on a total prohibition of the use of plant protection products for all farmers would be in the nature of a general intervention that affects a very large and, on the basis of abstract criteria, limited group of beneficiaries. That it is thus a question of a general regulation on the part of the legislature would strongly favour the view that such intervention does not constitute expropriation. As far as its general nature is concerned, the intervention shares several features with the normal, compensation-free regulation of the use of real property for arable farming, animal husbandry and forestry in pursuance of the planning, environmental and nature protection legislation, of which there are many examples, particularly in the legislation from the past ten years. The latest report on this legislation’s relationship with section 73 of the Danish Constitution is the report from the Minister of Justice and the Minister of Environment and Energy to the Danish Parliament dated 19 December 1996 (Folketingstidende (official report of parliamentary proceedings) 1996-97), Proceedings, p. 3021). An independent legal assessment of this legislation was presented by Professor Bent Christensen and Professor Henrik Zahle in a response of November 1996 to a now defunct Danish agricultural organisation. It is concluded in this report that the said legislation is not at variance with section 73 of the Danish Constitution, even though, in many cases, it intervenes deeply in the actual operation of farms. However, the courts might award individual compensation directly on the basis of section 73 of the Constitution if the restrictions on the use of a specific property were judged to be atypical and particularly radical (Bent Christensen and Henrik Zahle, 1996).

In an overall assessment based on the four criteria, the general nature of the intervention speaks clearly in favour of the view that there is no question of expropriation. The transfer criterion and the cause criterion point clearly in the same direction. As far as concerns the intensity of the intervention, not only the ordinary right of disposal of real property but also the agricultural production itself are subjected to further regulation. However, this further regulation does not constitute deprivation of property. The regulation does not differ, in principle, from other normal regulation of the agricultural sector’s operating conditions. In the evaluation of the intensity of the intervention, consideration also has to be paid to the fact that the regulation (the prohibition) applies to everyone, making the economic impact of any negative production effects less intensive for the individual, since such effects could to a certain extent (depending on, among other things, the international competition) be passed on in the product price. In addition, an (expected) trend in consumer preferences in the direction of increased demand for unsprayed products would reduce the intensity of the intervention still further.⁸⁵

The evaluation of how intensively a statutory total prohibition of the use of plant protection products would affect farmers, market gardeners, etc. – and thus the evaluation of whether, despite the generality of the regulation, such a prohibition approaches expropriative intervention – would in practice depend particularly on how the legislation’s provisions on a transitional scheme from the present forms of production were formulated, the length of the transitional scheme and the possibilities for dispensation and grants provided by the legislation.

Theoretically, the possibility cannot be excluded of some farmers being affected so atypically and severely that – despite the formal generality of the regulation – the regulation could, in their case, be described as expropriative. That could, for example, be the case if, in individual instances, the regulation in reality made it impossible for the farmer to continue his commercial activities. Despite the formal generality of the regulation, the courts might, in the case of farmers who were particularly seriously affected, award individual compensation directly on the basis of section 73 of the Constitution.

If, instead of a total prohibition of the use of pesticides, a regulatory scheme were introduced under which the legislature – or an administrative authority empowered by the legislature – designated particularly sensitive areas within which the use of pesticides was totally prohibited or subject to very restrictive rules, then, from an expropriation law point of view, any claims for compensation would have to be judged on the basis of similar considerations to those mentioned in the foregoing paragraph.

Whether, in the case of a farmer whose land lies in an area designated as particularly sensitive, the intervention could be described as expropriative would thus still depend on an overall evaluation on the basis of the four criteria: transfer, cause, intensity and general-specific (see section 5.3).

The transfer criteria would still clearly favour the view that the intervention was not expropriative, and so would the cause criteria provided there were the necessary scientific grounds for designating the area in question as particularly sensitive.

If there were such scientific grounds, the intervention could still be described as general intervention based on objective, abstract criteria (the sensitivity of the area).

However, in the evaluation of the intensity of the intervention, consideration would now have to be given to the fact that the regulation no longer affected all farmers, but only a narrower, limited group of farmers. The economic impact of any adverse effects of the intervention on production would thus be more intensive for those affected than in the case of a nationwide regulation.

Depending on how narrowly the regulated areas were delimited, there would therefore be a greater likelihood of the affected farmers claiming compensation on intensity grounds based on section 73 of the Constitution than in the case of a nationwide regulation.

However, the basis would still be that the regulation was a general, statutory regulation based on generally recognised environmental and health considerations and that such regulation could therefore be implemented without compensation. See also section 5.3.4 above concerning the Buffer Zone case (U 1998.1669 H).

6.7.4 Conclusion concerning general prohibition of use

From the considerations discussed in sections 6.7.1-6.7.3, the sub-committee concludes that, in relation to the EU rules, the WTO rules and section 73 of the Danish Constitution, it would be possible to introduce a (normally compensation-free) prohibition of the use of plant protection products, even in the agricultural industries. As mentioned, such a prohibition could cover plant protection products as such or groups of plant protection products. It could also, in principle, cover the whole of Denmark or parts thereof.

However, there would have to be objective environmental and/or health grounds for such a prohibition.

The larger the areas covered by the prohibition and the more the prohibition affects plant protection products authorised in other EU Member States, the more weighty and convincing must be the environmental and health grounds.

A prohibition of use applying, for example to product groups, could be of such a product-specific nature that it would be regarded as evasion of the conditions for authorisation given in Directive 91/414/EEC. In such case, the prohibition could only be accepted if it fulfilled the conditions for refusing authorisation for sale given in Article 10 of the directive.

6.7.5 The EU's water directives as basis for a prohibition of use

Directive 91/414/EEC contains no specific provisions concerning the relationship with the water directives. However, Directive 97/57/EC, concerning the uniform principles, contains certain provisions on the relationship between the authorisation rules in Directive 91/414/EEC with related directives and the water directives.

Firstly, it is stated in Directive 97/57/EC, point 2.5.1.2, that authorisation for the placing of a plant protection product on the market must not be granted if the concentration of the active ingredient, relevant metabolites, degradation products or reaction products in the groundwater exceeds the limit value for plant protection products in drinking water laid down in Directive 80/778/EEC. However, derogation from the rule is permissible if it is proved scientifically that the limit value is not exceeded under relevant field conditions.

Secondly, the preamble to Directive 97/57/EC, concerning the uniform principles, includes the following whereas clause: "the provisions of this directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States’ obligations under the directive concerned, and in particular Directives 75/440/EEC, 80/68/EEC and 80/778/EEC." It must be assumed that the coming water framework directive is covered by this provision.

On the face of it, the said whereas clause in the preamble to Directive 97/57/EC could indicate that nationally restricting the sale and use of plant protection products – generally or in connection with the assessment of specific applications to place products on the market – as an element in the implementation of the said water directives would be in accordance with Directive 91/414/EEC.

Furthermore, simultaneous use of product and environmental quality regulation basically implies that the product regulation respects the requirements behind the environmental quality regulation, including, for example, the water directives and the nature protection directives⁸⁶.

6.8 Changing the authorisation scheme: safety factors

A number of so-called safety factors are used in the basis for assessment in connection with the authorisation of plant protection products. If it were possible for the individual Member State itself to set the safety factors to be used, this could imply a tightening of the authorisation scheme that would result in some further restriction of the plant protection products that may be placed on the market in Denmark.

6.8.1 What are safety factors?

The potential effects of an active ingredient on humans and the environment are assessed on the basis of test results. Test results may show, for example, that, at a certain dose, an active ingredient kills half of the test animals. However, such a test result concerning the effects of the active ingredient on one or a few species of test animals cannot be assumed also to apply to all untested species, which may be far more sensitive. To take account of effects on the untested species as well, the test results are adjusted by means of so-called safety factors, which are used in the following way:

Effects on humans are investigated by means of animal tests, but a safety factor is included in the calculations to take account of the difference between the sensitivity of, say, rats or rabbits to a specific active ingredient and the sensitivity of humans. This is done, for example, by reducing (dividing) the values from the animal tests by a factor of 10, whereby the safety for humans is increased by a factor of 10 – the safety factor.

There are also differences between humans. An active ingredient can have health effects in different doses on different people. For example, children and elderly people may be more sensitive than healthy men. To take account of this difference, the values are often reduced (divided) by an additional factor of 10. Lastly, an active ingredient may have a particularly serious effect that is deemed to require extra high safety. A substance may be carcinogenic, for example, or affect reproduction, and in this case, an additional safety factor is used.

Environmental impacts are also investigated by means of animal tests, and here the use of safety factors depends mainly on two factors: firstly, that tests have only been carried out on one or a few species, while there are many species in the actual environment sprayed, and, secondly, that there are differences in the sensitivity of species to a given active ingredient.

Since one does not know in advance whether the one species actually tested is very sensitive or insensitive, one must assume that it is an insensitive species. In order to protect the untested species, one incorporates a safety factor in the calculations, as in the case of the health assessment.

6.8.2 Safety factors in connection with the assessment of health effects

When the Member States authorise plant protection products containing active ingredients that are listed in Annex I, they are required by Article 4(1) of Directive 91/414/EEC to apply the uniform principles for assessment and authorisation of plant protection products given in Annex VI to that directive, see Directive 97/57EC.

With respect to the assessment of the health effects of plant protection products, section C, 2.4.1, of Directive 97/57/EC includes rules on how the Member States are to decide concerning the impacts of plant protection products on human or animal health.

Point 2.4.1.1 in Directive 97/57/EC includes the following:

Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work is a framework directive that sets out the general principles for employers’ obligations. Article 6 of the directive states, for example, that the employer shall follow the technological development and combat risks at source by replacing what is dangerous with something that is not dangerous or is less dangerous and, at the same time, protect the employees collectively rather than individually. The employer shall do this through the choice of work equipment and chemical substances and preparations.

According to the directive, the authorities shall impose a number of obligations on employers. The directive is therefore not deemed to impose on the authorities authorising plant protection products any obligations beyond those the authorities have in pursuance of Directive 91/414/EEC.

The AOEL value includes a safety factor. The AOEL value, including the safety factor, is already fixed in connection with the assessment of the health impact of the specific active ingredients with a view to inclusion in Annex I.

The uniform principles do not at present contain any rules on how the actual AOEL values, including the safety values, are – purely technically – to be fixed.

The Commission has taken steps for the preparation of amplifying rules on the assessment of the health impacts of plant protection products, including rules on the fixing of safety factors. From the Commission’s latest draft for a guide to fixing the acceptable user exposure – the AOEL value – for plant protection products (doc. 7531/VI/95, rev. 4, of 20 October 1997) it appears (p. 9, sections 3.10 and 3.11, and p. 10, section 3.12) that a safety factor of 10 is at present being considered for each of the three areas specified. If two of the factors are used simultaneously for a specific active ingredient, the combined safety factor is 100: if all three are used simultaneously, it is 1000.

It is not possible at the present time to determine the final size of the individual safety factors or whether such rules will be binding or in the nature of guidelines or whether they will differ from the Danish rules. Until general rules/guidelines become available, the question of how, purely technically, to set the AOEL values, including the safety factors, remains open.

Lacking general rules/guidelines on the setting of AOEL values, including safety factors, the Commission and the Standing Committee on Plant Health set an AOEL value, including a safety factor, in connection with the listing of the first active ingredient (imazalil) in Annex I. This value was fixed in an audit report belonging to the directive.

With respect to use of the AOEL values, including the safety factors, in connection with national authorisation of plant protection products, it is stated in point A,2.b) of Directive 95/57/EE on the Uniform Principles that "When assessing applications and issuing authorisations, the Member States shall take into account …. the results of the assessment of these data (the review report)…".

Correspondingly, point 2.4 in the Annex to Directive 97/73/EC (imazalil), states:

The review report does not have the status of a binding act, but is a guideline document prepared by the Standing Committee for Plant Health.

In the revision report on imazalil, the AOEL value, including the safety factor, is put at 0.05 mg/kg bw/day (systemic), 6 month oral toxicity in rats, on the basis of AF=100 (the specified safety factor). Attached to this is a footnote with the following wording: "represents the best possible estimation according to the currently available methodology, which is however not yet completely harmonised."

In connection with the adoption of Directive 97/73/EC, the Standing Committee for Plant Health and the Commission declared as follows:

This declaration was adopted because some Member States, including Denmark, wished to set up a precedent for specified AOEL values being only in the nature of a guide. Where the prescribed AOEL value is found to provide too poor protection of sprayer operators/employees, Denmark (and other Member States) thereby have the possibility of specifying and using a lower AOEL value.

The Commission’s official minutes of the meeting at which the declaration was adopted – Summary Report of the Meeting of the Working Group on Plant Protection Products (Legislation), held on 10 and 11 July 1997 (6823/VI/97) – contains the following:

Directive 91/414/EEC and Directive 97/57/EC do not at the present time contain any rules on specification of AOEL values, including safety factors, in connection with the assessment of the health impacts of plant protection products.

As long as binding rules have not been provided on the use of health and safety factors in Directives 91/414/EEC and 97/57/EC, these provisions do not prevent Denmark from using national prescribed health safety factors.

The sub-committee is of the opinion that a closer interpretation of Directive 97/73/EC, including the AOEL value/safety factor given in the review report, is needed in order to judge whether Directive 97/73/EC prevents Denmark from using a lower AOEL value, including a higher health safety factor, in connection with the authorisation of products containing imazalil.

In view of the review report’s lack of formal status as an act, and in view of the wording of both point 2.4 in the Annex to Directive 97/73/EC, from which it appears that account should be taken of the conclusions of the review report, and point A,2.b of Directive 97/57/EC, from which it appears that the Member States must take account of the review report, the sub-committee is of the opinion that the Member States are not obliged to use the AOEL value, including the safety factor, prescribed in the review report, but are simply obliged to take it into account.

Furthermore, from the wording of the declaration adopted by the Commission and the Standing Committee for Plant Health in connection with the adoption of directive 97/73/EC, the declaration could indicate – although not containing any unambiguous statement – that the prescribed AOEL value, including the safety factor, can be regarded purely as a guideline for the Member States.

Referring to the above-mentioned report on the negotiations on Directive 97/57/EC, the Commission’s comments concerning the background for the declaration contribute greatly to interpretation of the declaration. The sub-committee is of the opinion that the declaration further supports the above-mentioned assessment.

The sub-committee is of the opinion that setting general national rules on the use of lower AOEL values/higher safety factors than those set, for example, in Directive 97/73/EC must be in accordance with the provisions of Articles 30 and 36 of the EU Treaty, as stated above.

If an increase of the safety factor cannot be implemented as a consequence of Directive 91/414/EEC, including Directive 97/57/EC and Directive 97/73/EC, then unilaterally raising the safety factor in Denmark for plant protection products imported from countries outside the EU must basically be regarded as unwarranted discrimination of WTO Members outside the EU in contravention of Article 2(3).

6.8.3 Safety factors in connection with the assessment of environmental impacts

In Article 4(1)a of Directive 91/414/EEC it is stated that the Member States, applying the uniform principles given in Annex VI, must ensure that the conditions mentioned in Article 4(1)b are fulfilled before authorising plant protection products.

Directive 97/57/EC on the uniform principles contains the following requirement in the 2nd whereas clause in the Preamble. The formulation "equivalent manner" almost indicates that the provisions in the uniform principles are totally harmonised.

2nd whereas clause:

Concerning the assessment of the environmental impacts of plant protection products, section c, point 2.5.2.1 and point 2.5.2.2 of Directive 97/57/EC contain rules on how the Member States are to decide with respect to the impact of plant protection products on non-target species, i.e. aquatic organisms, birds, mammals and earthworms.

Point 2.5.2.2, for example, states:

"Where there is a possibility of aquatic organisms being exposed, no authorization shall be granted if:

- the toxicity/exposure ratio for fish and Daphnia is less than 100 for acute exposure and less than 10 for long-term exposure,…".

That this concerns the use of safety factors appears from the fact that authorisation must not be granted if the ratio between specified effects and exposure is less than 100 or less than 10.

These safety factors in the uniform principles are lower than those currently used in Denmark, cf. "Guide to assessment of plant protection products" of 30 August 1994, bottom of page 19 – top of page 20, under the middle of page 23 and the bottom of page 24. This difference means that "more is needed" before – according to the uniform principles, the effects of a plant protection product are regarded as unacceptable for certain groups of organisms – than according to the Danish assessment principles.

With respect to the wording of points C.2.5.2.1 and 2.5.2.2 in Directive 97/57/EC (".. no authorisation shall be granted if ..") it can be held that, seen in isolation, the rules appear, from their wording, as minimum rules that ensure that authorisation is not granted in certain cases. This seems to indicate that stricter safety factors than those prescribed in Directive 97/57/EC can be used.

Conversely, the Preamble – particularly the 2nd whereas clause – indicates that the purpose of the directive is a total harmonisation of the rules, which seems to indicate that stricter safety factors than those prescribed in Directive 97/57/EC may not be used.

The sub-committee is of the opinion that the whereas clause in the Preamble concerning the purpose of the directive must be assigned such importance that it must be assumed that Directive 91/414/EEC, including Directive 97/57/EC, prevents Denmark from using higher safety factors than those prescribed in Annex VI when assessing the environmental impacts of plant protection products.

An increase in the safety factors used in connection with the administrative authorisation procedure would have to be notified and would therefore constitute a technical regulation that must be judged on the basis of the TBT Agreement.

If Directive 91/414/EEC thus prevents the use of higher safety factors than those set in Directive 97/57/EC, setting a higher safety factor in connection with imports from third countries would presumably contravene the obligation to accord imported products the same treatment as internal products, cf. Article 2(1) of the TBT Agreement.

6.8.4 Conclusion concerning changing safety factors

The sub-committee is of the opinion that Directive 91/414/EEC prevents Denmark from using higher safety factors than those prescribed in Directive 97/57/EC when assessing the environmental impacts of plant protection products.

Furthermore, the sub-committee believes that Denmark may use its own safety factors when assessing the health impacts of plant protection products since neither generally nor in specific cases have binding rules concerning health safety factors been laid down at Community level. National rules on this must be in conformity with Articles 30-36 of the EU Treaty. This implies that such rules must be based on objective grounds, that the rules must not go further than necessary, and that there must not be alternative regulatory instruments that would constitute less of a barrier to trade. If the rules can be accepted under EU law, they will also be acceptable under WTO law provided they do not discriminate against third countries.

6.9 Changing the authorisation scheme: integrated control

As will be seen from section 6.8, in the long term, there will presumably be no possibility of independently, nationally tightening the authorisation scheme by using special safety factors.

However, the sub-committee is of the opinion that, on another point, Denmark may be able to tighten the authorisation procedure. It can do so to some extent in the form of an isolated, national measure and by influencing the entire EU authorisation scheme by supplementing some vague, elastic provisions in Directive 91/414/EEC and Directive 97/57/EC⁸⁷.

This possibility of supplementing and influencing concerns the so-called integrated prevention and control mentioned in the directive under good plant protection practice.

As mentioned, integrated control is defined as follows in Article 2, No. 13, of Directive 91/414/EEC:

The principle of integrated control thus means keeping the use of chemical plant protection products at an absolute minimum, although the level must be economically acceptable at farm level, through a combination of other methods (e.g. the use of predatory insects to control pests).

Directive 91/414/EEC requires the EU Member States to pay attention to the principle of integrated prevention and control in their administration of the rules on plant protection products. This appears from Article 3(3), which reads as follows:

In Directive 97/57/EC, which contains the EU’s uniform principles for assessment and authorisation of plant protection products, integrated prevention and control is among the principles that must be observed in the assessment and decision-making process in connection with the authorisation of the placing of specific plant protection products on the market.

Point B(1) No. 2 of the Annex to the Directive (97/57/EC) reads as follows:

It is stated in point C(1) No. 4 of the Annex to the same directive that:

The concepts "integrated prevention" and "integrated control" are in the nature of legal standards (vague, elastic provisions). Except for the definition in Article 2, No. 13, the content of the concepts is not set out in detail in the directives. Nor, in an EU context, has there been any closer definition in practice of what integrated prevention and control actually implies in a number of specific areas.

This means that, here, Denmark basically has some discretion with respect to (refusing) authorisation of plant protection products and to making authorisation subject to certain conditions of use. In the case of specific crops for which suitable cultivation or prevention and control standards that do not cause unacceptable damage or loss can be established, authorisation of a plant protection product can be entirely or partially refused under reference to the provisions on integrated prevention and control. In the opinion of the sub-committee, there do not in such situations have to be concrete environmental grounds for refusing, either entirely or partially, to grant authorisation.

However, in order to refuse authorisation or set conditions on the basis of the principle concerning integrated prevention and control, Danish authorities must be able to refer to reliable studies or similar showing that pests can be prevented and/or controlled entirely or partially by alternative means.

Also required are concrete assessments of the economic consequences of minimum use of plant protection products in individual crops in Denmark.

If Denmark were to establish technically and economically well-founded principles for integrated prevention and control relatively quickly, this could influence the detailing or supplementation of the content of the vague, elastic provisions cited above from Directive 91/414/EEC and Directive 97/57/EC and thus the entire, real content of the EU rules on the placing of plant protection products on the market in the direction of lower consumption of such products.

The sub-committee is of the opinion that, within the framework of EU law, WTO law would not prevent a scientifically based prioritisation of integrated prevention and control.

6.10 Changing limit values for pesticide residues in food products

As will be seen from section 3.2 and 5.1.14 above, one of the problems studied by the sub-committee is whether Denmark is able (independently) to set very low limit values for pesticide residues in food products.

Section 5.1.14 gives a general overview of EU directives on pesticide residues in food products.

This section gives the sub-committee’s conclusions concerning national freedom of action in relation to the EU rules and also in relation to the WTO rules.

6.10.1 EU rules

As will be seen from section 5.1.14 above, the EU directives on pesticide residues must be regarded as an expression of total harmonisation. Furthermore, the directives are based on Article 43 of the EU Treaty (on the Common Agricultural Policy), so the environmental guarantee in Article 100a does not apply to this regulation (see section 5.1.4 above).

For this reason, the sub-committee considers that the EU directives on the setting of maximum limit values in food products prevent Denmark from introducing stricter national provisions for the pesticides and food products that are already covered by totally harmonised EU regulation.

By way of modification to this, Denmark, acting in accordance with the said EU directives, could set temporary, national maximum limit values for the remaining group of pesticides and food products in transitional periods – in other words, as long as the remaining group of pesticides and food products are not covered by totally harmonised EU regulation. This modification does not extend very far since, in the event of disputes with other Member States, such national maximum limit values would be subject to a committee procedure, and, if proposed by the Commission, another temporary EU maximum limit value could be adopted by the Standing Committee for Plant Health by a qualified majority.

Furthermore, national rules on temporary maximum limit values must be in accordance with Articles 30-36 of the EU Treaty. That means that such rules must be based on objective environmental or health grounds, that they must not go further than necessary and that there must not be alternative regulatory instruments that would constitute less of a barrier to trade.

6.10.2 WTO rules

The question of lower limit values for pesticide residues in food products must be considered not only in the light of EU law but also in the light of WTO law.

If the lower limit value were not in accordance with EU rules, it seems obvious to assume that particularly low limit values for food products imported from countries outside the EU would have to be regarded as unwarranted discrimination in violation of Article 2(3).⁸⁸

6.10.3 Conclusion concerning pesticide residues in food products

For the above reasons, particularly those given in section 6.10.1, the general conclusion must be that, in the medium and long term, Denmark has in reality no possibility of independently setting very low limit values for pesticide residues in food products.

6.11 Taxes on pesticides

Taxes on plant protection products can be used as an instrument for achieving a lower consumption of these products.

The tax instrument is already used in Denmark, since taxes are levied on plant protection products. Up until 1996 a sales tax of 3% was levied on plant protection products at the wholesale level, together with an annual charge of DKK 500 per authorised product, cf. what was then section 36 of Act on Chemical Substances and Products.

In 1995, the Folketing passed Act No. 416 of 14 June 1995, which went into force on 1 January 1996, abolishing the 3% tax on plant protection products and instead raising the rate of taxation on herbicides, fungicides, growth regulators and repellents to 15% and the rate on insecticides and soil disinfectants to 37%. The high rate for insecticides was mainly due to the cheapness of these products. The tax of 3% at the wholesale level was maintained for biocides and microbiological plant protection products.

The taxes were increased with effect from 1 November 1998 (by Act No. 417 of 26 June 1998). The tax rates (rounded up) are now:

Herbicides, fungicides, growth regulators and repellents: 33% (of the retail price before tax).

Insecticides and soil disinfectants: 54% (of the retail price before tax)

Algicides, wood protection products, slimicides for use in the paper pulp industry, products against rats, mice, etc. and microbiological plant protection products: 3% (of the wholesale price).

The tax is collected from domestic manufacturers and importers and is a pure ad valorem tax.

In connection with the increases in the rates of taxation in 1995 and 1998, the following alternative forms of taxation were assessed: a tax on environmental load, a tax per krone (sic) active ingredient and a tax per normal dose.

The Danish taxes on plant protection products have been combined with a national scheme on reimbursement of the taxes to the agricultural industries.

For example, in connection with an increase in the tax in 1995, the Folketing decided to reduce the county land valuation tax for farms and properties used for market gardening, nursery production and fruit production with a view to an indirect reimbursement. Since the revenue from the land valuation tax was previously used to finance some agricultural funds, which were used for, inter alia, development works in farming, fruit production and market gardening, it was agreed that some of the revenue from the pesticide tax should be transferred to the funds in order to maintain an unchanged level of activity.

Suspending collection of the land valuation tax compensated farmers and producers relatively precisely for the reduction of the economic yield from the land resulting from the pesticide tax, since pesticide consumption is generally highest on land with a high land valuation.

In connection with the increase in 1998 it was decided to allocate DKK 70 million for activities aimed at reducing the use of pesticides still further and for monitoring activities. DKK 50 million were allocated for these purposes for the following three years and DKK 25 million in each of the years 2002 and 2003. The remainder of the revenue is transferred to the Ministry of Food and will be allocated in connection with future budget negotiations.

In connection with the adoption of the tax increases in 1995 and 1998, the entire schemes, comprising tax increases and reimbursement schemes were notified in accordance with the rules on state aid (Article 93(3)).

The Commission accepted the increase in 1995 but made it known that it still had reservations, expressed earlier, concerning the above-mentioned funds. The Commission also noted the Danish authorities' promise to help ensure against any form of discrimination.

In connection with the Commission's acceptance of the increase in 1998, the Commission wrote that it had attached importance to the environmental objectives, including the objective of the Pesticide Action Plan from 1987, and that the use of the revenue, if in the nature of state aid, would be notified in accordance with current EU law.

If a tax is charged both on imported and nationally produced goods, it is a so-called internal charge, the legality of which must be judged in accordance with the rules given in Article 95 of the EU Treaty, which prohibit fiscal discrimination of goods from other countries.

According to Article 95 of the EU Treaty, it would be possible to increase the existing Danish charges as long as they did not discriminate against plant protection products imported from other EU Member States.

It is difficult to decide whether there is an upper legal limit for the size of the charges. On the other hand, reimbursement of the taxes collected to the agricultural industries would be covered by the EU's rules on state aid and would therefore have to be approved by the EU.

It can be added that the WTO rules do not prevent the imposition of taxes provided the taxes are not discriminatory. It has never been argued in practice that, under WTO law, there is an upper limit on the size of such taxes where the taxes are not discriminatory or a form of protection of internal products.

6.11.1 Differentiated VAT

VAT is a tax, which means that rules on VAT, including VAT differentiation must be assessed on the basis of the 6th VAT directive, Directive 77/388/EEC of 17 May 1977 with later amendments. This directive lists the goods and services that are subject to VAT.

The directive also contains some rules on the rates of VAT. Annex H to the directive lists goods and services that can have a reduced rate. The goods in question include food products and foodstuffs. It follows from these rules that a lower VAT rate can be used for organic food products, for example, than for other food products.

6.12 Quotas for use of plant protection products

Use of plant protection products can be restricted by means of a quota system. In that connection, the quota system would have to fulfil the requirements given in section 6.7 above concerning general prohibition of the use of plant protection products.

A quota system can be designed in such a way that the individual farmer/producer is allocated a yearly quota of plant protection products that he may purchase. The quota is based on the expected crop composition on the property.

It would hardly be possible to extend the quota system by creating the right to buy and sell quotas, as is done, for example, in the case of milk quotas because that would lead to a risk of an inappropriate distribution of the use of plant protection products, with a very heavy load on some land owing to the owner buying many quotas.

6.13 Agreements with the agricultural industries

The foregoing has dealt mainly with regulatory provisions that are based on official, unilaterally introduced prohibitions or restrictions.

This section gives the sub-committee’s considerations concerning an alternative regulatory instrument consisting of mutual agreements between the authorities and the agricultural industries on phasing out or reducing the use of plant protection products.

6.13.1 Agreements based on Section 10 of the Environmental Protection Act

Section 10 of the Environmental Protection Act contains a special provision on environmental agreements. Such agreements can be entered into with, for example, trade organisations.

Section 10(1) and (2) of the Environmental Protection Act read as follows:

However, this provision can hardly be used in relation to pesticide consumption in the agricultural industries because the use of pesticides in those industries comes under the Act on Chemical Substances and Products and not under the Environmental Protection Act. It must be assumed that the fact that the agreement provision is placed in the Environmental Protection Act means that it covers only agreements on matters that are otherwise regulated on the basis of this Act.

6.13.2 Agreements that are not based on law

That means that an agreement scheme must be based on a so-called voluntary agreement between the Minister of Environment and Energy and the agricultural industries.

A voluntary agreement is in the nature of a political agreement that is entered into without any legal basis. It usually consists in the private parties to the agreement (the trade organisations) promising to ensure that the use of one or more undesirable substances is reduced to a specific percentage of the present consumption by a specific date. In return, the Minister refrains from introducing other regulation of use of the substances in question for the term of the agreement.

The agreement is only politically binding on the parties to the agreement. If the agreement is not observed by the industry, the Minister can response by terminating the agreement and introducing binding rules in the form of executive orders or, possibly, new legislation.

In certain cases an agreement can be supplemented by legislation or other rules. For example, the Agreement of 28 November 1996 between the Minister of Environment and Energy and the Danish Contractors' Association's Demolition Section (acceded to by the Minister of Housing and Urban Affairs) on selective demolition was supplemented by Executive Order of 18 August 1997 on selective demolition of buildings for livestock and Circular of 1 January 1997 on municipal regulations on separation of building and construction waste with a view to recycling.⁸⁹

According to a list from May 1998 from the Environmental Protection Agency, Division on Enforcement and Legislation, 13 different agreements have been entered into in the environmental field. Five of them have been fulfilled or are expected to be fulfilled in accordance with their content. The agreements in question concern the quality of diesel oil, lead batteries, refrigerators, the Danish Oil Industry's Association for Remediation of Retail Sites and VOC.

The PVC Agreement of 3 April 1991 can be used to illustrate the main points of a voluntary environmental agreement. PVC (polyvinyl chloride) is a plastic material that is used in large quantities for building and construction purposes and for packaging. The material causes environmental problems when it is being produced and when it is disposed of by incineration because hydrochloric acid, among other substances, is formed during the combustion process.

The parties to the PVC Agreement are the Minister of Environment and Energy, on one side, and the Confederation of Danish Industries, the Danish Plastics Federation and the retail trade, on the other. The main provision of the agreement concerns some reduction targets. For example, the amount of PVC packaging sent to incineration plants or landfill sites in the year 2000 must be reduced by 85 per cent compared with 1987. A recycling scheme is being established for building products, with a target of 72 per cent of the PVC in this area recycled by the year 2000.⁹⁰

6.13.3 Agreements and EU law

Voluntary agreements between the Minister of Environment and Energy and the agricultural industries must be notified to the Commission in accordance with the information procedure direction, Directive 98/34/EC. However, there are some exceptions to the rule concerning notification. It is not clear to what extent an agreement involving both private and public parties is covered by Articles 30-36 of the Treaty, but the Commission will have to decide on this in connection with such notification.

If the agreements are supplemented with grants, an evaluation must also be carried out as required by Article 92 of the EU Treaty (the state aid rules)⁹¹.

6.13.4 Enforcement of agreements

Most agreements up to the present time have been entered into with private organisations or others within industries with relatively few companies. The area is therefore clear.

In the case of an agreement with the agricultural industries on reduction of the use of plant protection products, the fact that the agreement would cover many small undertakings would be a problem. It might therefore be difficult to determine whether the agreement was observed.

6.14 Self-regulation

An alternative procedure for phasing out or reducing the use of plant protection products is voluntary agreements within the agricultural industries or between these and other industries.

An existing example is provided by an agreement of August 1998 between farmers and the flour and bread industry that is intended to ensure that all grain used for production of bread in Denmark has not been treated with RoundUp or other products containing glyphosate (see press release dated 7 August 1998 from the Danish Farmers Union and the Minister of Environment and Energy's response of 12 August 1998 to question No. S.965 from a Member of the Folketing).

Such voluntary restrictions would not be at variance with EU rules or WTO rules provided public authorities did not participate in the agreement or have any say in it. This, however, leaves the question of the relationship between such agreements and the competition rules.

6.15 Education and training

It is possible to make educational requirements in order to ensure that only persons who have undergone a specific course of education or training may use plant protection products.

With authority in the Act on Chemical Substances and Products, the Minister issued Executive Order No. 360 of 24 May 1993 on education and training of occupational users of plant protection products. The main purpose of this executive order is to ensure that only persons who have undergone a course of education use plant protection products. The main provisions are given in section 3(1) and section 4(1), which read as follows:

Annexes 4 and 5 to the Executive Order No. 360 set out the main training requirements for gaining a sprayer's certificate.

The requirements concerning education and training are not at variance with Directive 91/414/EEC since this directive only regulates the actual plant protection products.

The existing requirements concerning education and training could be expanded. For example, a holder of a sprayer's certificate could be required to renew his certificate at regular intervals by taking a new examination.

^73. FT 1993-94, Supplement A, col. 9193. See section 5.4. above on Section 35c and the assessments behind the inclusion of an active ingredient in the Prohibition List.    [Back]

^74. FT 1993-94, Supplement A, col. 6193ff.    [Back]

^75. See section 6.2.1. below.    [Back]

^76. Misuse must, for example, be understood to mean failure to comply with the rules for handling and use of plant protection products. There must be a certain probability that this non-compliance is actually occurring.    [Back]

^77. In addition, it must be regarded as difficult in this situation to arrive at a necessary rational relationship between a risk assessment that meets the requirements of Article 5(1)-(3) and a higher safety factor only for plant protection products from third countries.    [Back]

^78. See also section 5.1.5 above.    [Back]

^79. If the restrictions are not imposed in order to protect human and animal life or health, they will, however, be covered by the TBT Agreement provided a technical regulation is laid down in the form of requirements concerning plant protectionproducts, including requirements concerning labelling and similar.    [Back]

^80. Furthermore, it must be regarded as difficult in this situation to achieve a necessary rational relationship between a risk assessment that fulfils the requirements given in Article 5(1) to (3) and restriction of use only for plant protection products from third countries.    [Back]

^81. For the EU this would presumably constitute a breach of Article 2(3)1 of the SPS Agreement.    [Back]

^82. See also section 6.2.1 above on matters that are regulated by Directive 91/414/EEC.    [Back]

⁸³ As mentioned in section 5.1.5 above, a draft bill prohibiting the use of plant protection products in certain areas (including private gardens) has been notified to the Commission in pursuance of Directive 98/34/EC on Information Procedure. The Commission has presented an exhaustive opinion from which it appears that such a prohibition would, in particular, be at variance with Articles 4 and 8 of Directive 91/414/EEC. In the opinion of the Commission, the directive, through Article 2,1, covers every use, agricultural and non-agricultural, of the products in question. However, the Commission does not argue more closely for this view. As will be seen from section 6.7 of this report, the sub-committee is of the opinion that the directive does not regulate all cases of rules on use.    [Back]

^84. This section is based on a report dated 7 September 1998 from Professor Jens Peter Christensen, DLL. A few additions and editorial changes have been made to the report.    [Back]

^85. According to the report "Market perspectives for organic food products", November 1998, by Bolette Abrahamsen and Jan Holm Ingemann, p. 68, the demand for organic food products must be expected to rise in the years ahead. The question of a premium is dealt with in the report, p. 63 f.    [Back]

⁸⁶ Council Directive 92/43/EEC on the conservation of habitats and of wild fauna and flora (Habitats) implies, cf. Article 6, that preservation objectives must be prepared at national level for the areas designated in pursuance of the directive. Depending on the circumstances, this could imply restrictions on the use of pesticides.     [Back]

⁸⁷ See also section 5.1.5 above.    [Back]

^88. It must be regarded as difficult to achieve the necessary rational relationship between a risk assessment that meets the requirements given in Article 5(1)-(3) and limit values that apply only to third countries.    [Back]

^89. The Environmental Protection Agency’s list of agreements from May 1998, cf. communication dated 12 June 1998, p. 12.    [Back]

^90. Moe, Miljøret – Miljøbeskyttelse (Environment Law – Environmental Protection), 3rd ed., p. 116, and Ellen Margrethe Basse, Affaldslovgivningen (Legislation on Waste), 1995, p. 369f.    [Back]

⁹¹ Concerning this, readers are referred to section 5.1.2 above (and to section 7.2.5 below) and to the sub-committee's supplementary report: "Legal questions concerning total restructuring of Danish agriculture for organic production", March 1999, section 8.    [Back]

| Front page | | Contents | | Previous | | Next | | Top |