Agrichem BV v Minister for Agriculture and Food

 
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[2005] IEHC 99

THE HIGH COURT

842JR/2003
AGRICHEM BV v MIN FOR AGRICULTURE

BETWEEN

AGRICHEM BV
APPLICANT

AND

MINISTER FOR AGRICULTURE AND FOOD
RESPONDENT

2003/842JR - Finnegan - High - 23/3/2005 - 2005 1 131 2005 IEHC 99

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 1996 2 ILRM 46

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

Abstract:

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

Finnegan P.
1

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.

2

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.

3

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.

4

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.

5

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.

6

Article 13 of the 1991 Directive deals with data requirements, data protection and confidentiality. It provides as follows -

7

13 1. Without prejudice to Article 10, Member States shall require that applicants for authorization of a plant protection product submit with their application:

8

(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and

9

(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.

10

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.

11

3. In granting authorizations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:

12

(a) unless the applicant has agreed with the first applicant that use may be made of such information: or

13

(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

14

(c) for periods not exceeding 10 years from the date of the decision in each Member State and provided for in existing national rules, concerning an active substance on the market two years after the date of notification of this Directive; and

15

(d) for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex 1, or to vary the conditions for, or to maintain the inclusion of an active substance in Annex 1, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex 1, unless the five-year period expires before the period provided for in paragraphs 3 (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.

16

4. In granting authorizations, Member States shall not make use of the information referred to in Annex III to the benefit of other applicants:

17

(a) unless the applicant has agreed with the first applicant that use may be made of such information; or

18

(b) for a period of 10 years from first authorization of the plant protection product in any Member State, where authorization follows the inclusion in Annex 1 of any active substance contained in the product; or

19

(c) for periods not exceeding 10 years and provided for in existing national

20

rules after the first authorization of the plant protection product in each Member State, where that authorization precedes inclusion in Annex 1 of any active substance contained in the product.

The effect of Article 13 is as follows û
21

The applicant for authorisation of a plant protection product must comply with Article 13.1(a) and (b). Article 13.2 provides that it shall not be necessary to comply with Article 13.1(b) by providing an Annex II dossier but shall be sufficient to identify the active substance if it is already listed in Annex I. Article 13 in effect distinguishes between a first applicant for inclusion in Annex I ("the main...

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