Agrichem BV v Minister for Agriculture and Food
 IEHC 99
THE HIGH COURT
EEC DIR 91/414
EC DIR 2002/37
EC DIR 2002/37 ANNEX 1
EEC DIR 91/414 ART 4
EEC DIR 91/414 ART 4.3
EEC DIR 91/414 ART 4.1
EEC DIR 91/414 ART 4.4
EEC DIR 91/414 ART 4.5
EEC DIR 91/414 ART 4.6
EEC DIR 91/414 ANNEX I
EEC DIR 91/414 ANNEX II
EEC DIR 91/414 ANNEX III
EEC DIR 91/414 ART 9
EEC DIR 91/414 ART 13
EEC DIR 91/414 ART 13.1(a)
EEC DIR 91/414 ART 13.1(b)
EEC DIR 91/414 ART 13.2
EEC DIR 91/414 ART 13.3
EEC DIR 91/414 ART 13.4
EEC DIR 91/414 SCHED 1
EC DIR 2002/37 ART 3
EUROPEAN COMMUNITIES (AUTHORISATION PLACING ON THE MARKET USES & CONTROL OF PLANT PROTECTION PRODUCTS) REGS 1994-2001
EUROPEAN COMMUNITIES (AUTHORISATION PLACING ON THE MARKET USE & CONTROL OF PLANT PROTECTION PRODUCTS) REGS 2003 SI 83/2003
CARLTONA LTD v COMMISSIONERS OF WORKS 1943 2 AER 560
TANG v MIN FOR JUSTICE
EC DIR 2002/37 RECITAL 8
EC DIR 2002/37 ART 4
EC DIR 2002/37 ART 4.1
EC DIR 2002/37 ART 4.2
EC DIR 2002/37 ART 4(1)
EC DIR 2002/37 ANNEX VI
EC DIR 2002/37 RECITAL 9O
ECD PRINCIPLES OF GOOD LABORATORY PRACTICE ENVIRONMENT MONOGRAPH NO 45 PARA 9.1
EEC DIR 91/414 ANNEX II POINT 6.2
Statutory interpretation - European law - Legislative intention - Purpose of European Directive - Council Directive 91/414/EEC, articles 4 and 13 - Directive 2002/37/EC, Article 4
2003/842JR - Finnegan - High - 23/3/2005 - 2005 1 131 2005 IEHC 99
Council Directive 91/414/EC provides for a harmonised Community regime for the control of plant protection products. Article 4 of the Directive of 1991 provides that such products may not be authorised by Member States unless its ingredients are listed in annex I. Article 13 of the Directive provides that inclusion of a substance in annex I requires submission of information in accordance with annex II of the Directive. The effect of article 13 of the Directive of 1991 was that the applicant, a producer of generic products, was entitled, in respect of annex II requirements, to avail of information provided by the main producers who had previously applied for authorisation of the same product. Article 4(1) of Council Directive 2002/37/EC provides that “Member States shall review the authorisation for each plant protection product containing ethofumesate to ensure that the conditions relating to ethofumesate set out in annex I to Directive 91/414/EEC are complied with…” Article 4(2) of the Directive of 2002 provides that “Member States shall, for each [such] product which were listed in annex I to Directive 91/414/EEC by 1 March, 2003, re-evaluate the product in accordance with the uniform principles provided for in [the] Directive of . On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in article 4(1) of the Directive of 1991. Where necessary and by 28 February, 2007 at the latest, they shall amend or withdraw the authorisation for each such…product”
The applicant applied to judicially review the decision of the respondent to withdraw product authorisation for those of its products containing ethofumesate after it had purportedly failed to provide complete information for the purposes of annex II of the Directive of 1991. The applicant argued, inter alia, that the respondent had erred in requiring the applicant to furnish the information in annex II of the Directive of 1991 and that article 4(1) of the Directive of 2002 only required the respondent to review product authorisations in order to satisfy himself that the conditions relating to ethofumesate set out in annex I of the Directive of 1991 were complied with.
Held by Finnegan P in granting the applicant relief on the basis that the respondent had erred in requiring the applicant to furnish information in annex II of the Directive of 1991 that the term “re-evaluation” used in Article 4(2) of the Directive of 2002 envisaged more detailed consideration than a “review” as the term was used in Article 4(1) of the Directive of 2002. In those circumstances, the respondent was not entitled to require the applicant to satisfy it in relation to the annex II dossier that it was not affected by the data protection provisions of article 13 of the Directive of 1991. On a review under article 4(1), the respondent was restricted to ensuring that the conditions set out in annex I of the Directive of 1991, as amended by the Directive of 2002, were complied with.
The Applicant is a Dutch Company and is a distributor of generic agrochemical products. It has three products distributed in Ireland which include an active ingredient called "ethofumesate". The products are designed for use in controlling weeds in sugar beet. One of the products was first distributed in Ireland in 1996 and the other two first distributed in 2001. In respect of the products the Applicant held product authorisations and these proceedings arise out of the purported withdrawal of the same by the Respondent.
There is a Community regime for the control of plant protection products contained principally in Council Directive 91/414/EEC (hereinafter the 1991 Directive). The purpose of the Directive is to harmonise the provisions for the control of plant protection products in Member States. This is achieved firstly by establishing a Community list of authorised active substances and admission to which list is a matter for the Community. Prior to an active substance being admitted to the Community list Member States could authorise use of the same in their territory for a limited period and the Applicant had the benefit of such authorisation for its three products. Secondly Member States can grant product authorisation for products containing an active substance entered on the Community list. The 1991 Directive provides that there should be uniformity between Member States in that the grant of a product authorisation in one Member State is to be recognised in another. The Directive deals with both the admission of an active substance to the Community list and the authorisation of products containing that substance in a Member State. Ethofumesate was added to the Community list by Directive 2002/37/EC (hereinafter the 2002 Directive) which came into effect on the 1st March 2003.
Admission of an active substance to the Community list entails a detailed and expensive process of assessment. The process is carried out by a Rapporteur Member State on behalf of the European Commission, in this case Sweden. The process of evaluation includes several expert bodies and experts from the Member States. The evaluation of ethofumesate took some 6½ years. Active substances authorised for the purposes of the 1991 Directive are set forth in Annex 1 of the same: ethofumesate was added to Annex 1 by the 2002 Directive.
With regard to plant protection products Article 4 of the 1991 Directive provides that the same may not be authorised by Member States unless its active substances are listed in Annex 1 and other conditions set out in Article 4 are complied with: the conditions in short provide for the submission of scientific and technical information in relation to the plant protection product. Article 4.3 requires Member States to ensure that compliance with the requirements of Article 4.1 is established by official or officially recognised tests and analysis carried out under agricultural plant health and environmental conditions relevant to the use of the product. Article 4.4 and 5 provide that authorisations may be reviewed. Article 4.6 provides that authorisations may be cancelled or modified.
In order to obtain inclusion of an active substance in Annex I the 1991 Directive requires submission of a dossier in accordance with Annex II of the Directive and a dossier in accordance with Annex III of the Directive on at least one preparation containing the active substance. Article 9 provides that application for authorisation of a plant protection product shall be made by or on behalf of the person responsible for first placing it on the market in a Member State to the competent authority of each Member State where the plant protection product is intended to be placed on the market.
Article 13 of the 1991 Directive deals with data requirements, data protection and confidentiality. It provides as follows -
13 1. Without prejudice to Article 10, Member States shall require that applicants for authorization of a plant protection product submit with their application:
(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and
(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.
2. By way of derogation from paragraph 1, and without prejudice to the provisions of paragraphs 3 and 4, applicants shall be exempted from supplying the information required under paragraph 1 (b) except for that identifying the active substance if the active substance is already listed in Annex 1, taking into account the conditions of inclusion in Annex 1, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application.
3. In granting authorizations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:
(a) unless the applicant has agreed with the first applicant that use may be made of such information: or
(b) for a period of 10 years from first inclusion in Annex 1 of an active substance not on the market two years after the date of notification of this Directive; or
(c) for periods not exceeding 10 years from the date of the...
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