Avis juridique important

Commission Regulation (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market Official Journal L 049 , 04/03/1995 P. 0050 - 0052

COMMISSION REGULATION (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by the Commission Directive 94/79/EC (2), and in particular Article 8 (2) thereof, Having regard to Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC concerning the placing of plant protection products on the market (3), and in particular Article 5 (2) and (5) thereof, Whereas owing to the accession of Austria, Finland and Sweden to the European Community an imbalance has arisen in the responsibilities borne by the Member States as rapporteurs for the 89 active substances covered by the first phase of the programme of work for reassessment of the active substances on the market two years after the date of notification of Directive 91/414/EEC; whereas in such a situation a reallocation of active substances has to be undertaken; whereas Annexes I and III to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92 (4) should therefore be amended; Whereas the number of substances to be reallocated must be limited to the minimum required to ensure a proper balance in the responsibility borne by each of the 15 Member States; Whereas, however, the reallocation should also take into account the need to keep substances with similar properties under evaluation by one Member State, as well as the need to ensure that after reallocation all substances are examined by a designated rapporteur Member State that has authorized the substance; Whereas account had also to be taken of indications from certain Member States regarding the advanced stage already reached in the preparation of the evaluation of certain active substances; Whereas, to comply with these requirements, it has been necessary to reallocate one substance between Member States of the Community as constituted at 31 December 1994; Whereas notifiers of active substances reallocated to another rapporteur Member State must be assured of flexibility with regard to adherence to the deadline set for the introduction of the dossiers, where they can show that the reallocation has led to a delay in the presentation of the dossiers to the new designated rapporteur Member State; Whereas it is necessary to provide that the original rapporteur Member State will transfer to the new designated rapporteur Member State all correspondence and information which it received as rapporteur Member State on the active substance concerned; Whereas any producers (that is, manufacturers and importers of substances produced outside the Community) having a permanent office in the territory of one of the acceding Member States must be given the opportunity of participating in the programme in their own right; whereas this opportunity should however not affect the original timetable for the work; Whereas the participation of the notifiers in the programme of work is a long-term exercise, requiring more specific provisions for cases where a notifier decides to withdraw its participation or to agree to a transfer of its participation to another producer; whereas such transfer may be of particular interest for producers in the acceding Member States that were originally required to participate via a notifier which had its permanent office in one of the 12 Member States before the accessions; Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant Health, HAS ADOPTED THIS REGULATION: Article 1 Regulation (EEC) No 3600/92 is amended as follows: 1. in Article 4, the following paragraph 1a is inserted: '1a. Notwithstanding the provisions of paragraph 1, producers having a permanent office in Austria, Finland or Sweden may notify the Commission by 30 April 1995 at the latest.'; 2. Article 5 is amended as follows: (a) the following subparagraph is added to paragraph 5: 'Where such different Member State has been designated as rapporteur Member State, the original Member State shall inform thereof the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.'; (b) the following paragraph 6 is added: '6. When a notifier decides to end its participation in the programme of works for an active substance, he shall inform thereof the rapporteur Member State, the Commission and the other notifiers for the substance concerned. When a notifier agrees with another producer that he shall be replaced for the purposes of further participation in the programme of works under this Regulation, the notifier and such other producer shall inform the rapporteur Member State and the Commission by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier's duties as set out in Articles 6 to 8; they shall assure that the other notifiers for the substance concerned are informed as well.'; 3. in Article 6 (5), the first indent is replaced by the following: '- a new time-limit has been granted for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3; a new time-limit will only be granted where the delay is proved to have been caused by efforts to present collective dossiers, or by additional efforts to be made by the notifier (or notifiers) on account of a decision to designate another rapporteur Member State in accordance with Article 5 (5),'; 4. in Article 7 (1) (a), the following is added: 'the order of examination is, however, not affected by dossiers presented by notifiers referred to in Article 4 (1) (a)'. Article 2 Regulation (EC) No 933/94 is hereby amended as follows: 1. in Annex I, for the following active substances mentioned in column A, the designated rapporteur Member States are amended as follows in column B: "" ID="1">'Amitraz> ID="2">Austria"> ID="1">Lamba-cyhalothrin> ID="2">Sweden"> ID="1">Deltamethrin> ID="2">Sweden"> ID="1">Lindane> ID="2">Austria"> ID="1">Dinocap> ID="2">Austria"> ID="1">Propiconazol> ID="2">Finland"> ID="1">Alachlor> ID="2">Spain"> ID="1">Ethofumesate> ID="2">Sweden"> ID="1">Desmedipham> ID="2">Finland"> ID="1">Phenmedipham> ID="2">Finland"> ID="1">Propyzamide> ID="2">Sweden"> ID="1">Pyridate> ID="2">Austria'"> 2. the following is added to Annex III: AUSTRIA Bundesministerium fuer Land- und Forstwirtschaft, p.a. Bundesamt und Forschungszentrum fuer Landwirtschaft, Trunnerstrasse 5, A-1020 Wien; FINLAND Kasvintuotannon tarkastuskeskus, Torjunta-aineiden toimiala, PL 42, FIN-00501 Helsinki; SWEDEN Kemikalieinspektionen, PO Box 1384, S-17127 Solna. Article 3 This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 March 1995. For the Commission Franz FISCHLER Member of the Commission (1) OJ No L 230, 19. 8. 1991, p. 1. (2) OJ No L 354, 31. 12. 1994, p. 16. (3) OJ No L 366, 15. 12. 1992, p. 10. (4) OJ No L 107, 28. 4. 1994, p. 8.

COMMISSION REGULATION (EC) No 491/95 of 3 March 1995 amending Regulation (EEC) No 3600/92 and Regulation (EC) No 933/94, in particular with regard to the integration of the designated public authorities and the producers in Austria, Finland and Sweden in the implementation of the first stage of the programme of work referred to in Article 8 (2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by the Commission Directive 94/79/EC (2), and in particular Article 8 (2) thereof,

Having regard to Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC concerning the placing of plant protection products on the market (3), and in particular Article 5 (2) and (5) thereof,

Whereas owing to the accession of Austria, Finland and Sweden to the European Community an imbalance has arisen in the responsibilities borne by the Member States as rapporteurs for the 89 active substances covered by the first phase of the programme of work for reassessment of the active substances on the market two years after the date of notification of Directive 91/414/EEC; whereas in such a situation a reallocation of active substances has to be undertaken; whereas Annexes I and III to Commission Regulation (EC) No 933/94 of 27 April 1994 laying down the active substances of plant protection products and designating the rapporteur Member States for the implementation of Commission Regulation (EEC) No 3600/92 (4) should therefore be amended;

Whereas the number of substances to be reallocated must be limited to the minimum required to ensure a proper balance in the responsibility borne by each of the 15 Member States;

Whereas, however, the reallocation should also take into account the need to keep substances with similar properties under evaluation by one Member State, as well as the need to ensure that after reallocation all substances are examined by a designated rapporteur Member State that has authorized the substance;

Whereas account had also to be taken of indications from certain Member States regarding the advanced stage already reached in the preparation of the evaluation of certain active substances;

Whereas, to comply with these requirements, it has been necessary to reallocate one substance between Member States of the Community as constituted at 31 December 1994;

Whereas notifiers of active substances reallocated to another rapporteur Member State must be assured of flexibility with regard to adherence to the deadline set for the introduction of the dossiers, where they can show that the reallocation has led to a delay in the presentation of the dossiers to the new designated rapporteur Member State;

Whereas it is necessary to provide that the original rapporteur Member State will transfer to the new designated rapporteur Member State all correspondence and information which it received as rapporteur Member State on the active substance concerned;

Whereas any producers (that is, manufacturers and importers of substances produced outside the Community) having a permanent office in the territory of one of the acceding Member States must be given the opportunity of participating in the programme in their own right; whereas this opportunity should however not affect the original timetable for the work;

Whereas the participation of the notifiers in the programme of work is a long-term exercise, requiring more specific provisions for cases where a notifier decides to withdraw its participation or to agree to a transfer of its participation to another producer; whereas such transfer may be of particular interest for producers in the acceding Member States that were originally required to participate via a notifier which had its permanent office in one of the 12 Member States before the accessions;

Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS REGULATION:

Regulation (EEC) No 3600/92 is amended as follows:

1. in Article 4, the following paragraph 1a is inserted:

'1a. Notwithstanding the provisions of paragraph 1, producers having a permanent office in Austria, Finland or Sweden may notify the Commission by 30 April 1995 at the latest.';

2. Article 5 is amended as follows:

(a) the following subparagraph is added to paragraph 5:

'Where such different Member State has been designated as rapporteur Member State, the original Member State shall inform thereof the notifiers concerned and shall transfer to the newly designated rapporteur Member State all correspondence and information which it has received as rapporteur Member State for the active substance concerned.';

(b) the following paragraph 6 is added:

'6. When a notifier decides to end its participation in the programme of works for an active substance, he shall inform thereof the rapporteur Member State, the Commission and the other notifiers for the substance concerned.

When a notifier agrees with another producer that he shall be replaced for the purposes of further participation in the programme of works under this Regulation, the notifier and such other producer shall inform the rapporteur Member State and the Commission by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier's duties as set out in Articles 6 to 8; they shall assure that the other notifiers for the substance concerned are informed as well.';

3. in Article 6 (5), the first indent is replaced by the following:

'- a new time-limit has been granted for the submission of a dossier fulfilling the requirements of paragraphs 2 and 3; a new time-limit will only be granted where the delay is proved to have been caused by efforts to present collective dossiers, or by additional efforts to be made by the notifier (or notifiers) on account of a decision to designate another rapporteur Member State in accordance with Article 5 (5),';

4. in Article 7 (1) (a), the following is added:

'the order of examination is, however, not affected by dossiers presented by notifiers referred to in Article 4 (1) (a)'.

Article 2

Regulation (EC) No 933/94 is hereby amended as follows:

1. in Annex I, for the following active substances mentioned in column A, the designated rapporteur Member States are amended as follows in column B:

"" ID="1">'Amitraz> ID="2">Austria"> ID="1">Lamba-cyhalothrin> ID="2">Sweden"> ID="1">Deltamethrin> ID="2">Sweden"> ID="1">Lindane> ID="2">Austria"> ID="1">Dinocap> ID="2">Austria"> ID="1">Propiconazol> ID="2">Finland"> ID="1">Alachlor> ID="2">Spain"> ID="1">Ethofumesate> ID="2">Sweden"> ID="1">Desmedipham> ID="2">Finland"> ID="1">Phenmedipham> ID="2">Finland"> ID="1">Propyzamide> ID="2">Sweden"> ID="1">Pyridate> ID="2">Austria'">

2. the following is added to Annex III:

AUSTRIA

Bundesministerium fuer Land- und Forstwirtschaft,

p.a. Bundesamt und Forschungszentrum fuer Landwirtschaft,

Trunnerstrasse 5,

A-1020 Wien;

FINLAND

Kasvintuotannon tarkastuskeskus,

Torjunta-aineiden toimiala,

PL 42,

FIN-00501 Helsinki;

SWEDEN

Kemikalieinspektionen,

PO Box 1384,

S-17127 Solna.

Article 3

This Regulation shall enter into force on the seventh day following its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 3 March 1995.

For the Commission

Franz FISCHLER

Member of the Commission

(1) OJ No L 230, 19. 8. 1991, p. 1.

(2) OJ No L 354, 31. 12. 1994, p. 16.

(3) OJ No L 366, 15. 12. 1992, p. 10.

(4) OJ No L 107, 28. 4. 1994, p. 8.