24.12.2004

EN

Official Journal of the European Union

L 379/1

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COUNCIL REGULATION (EC) No 2223/2004

of 22 December 2004

amending Regulation (EC) No 1257/1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

Whereas:

(1)

The third indent of the second subparagraph of Article 47(2) of Council Regulation (EC) No 1257/1999 (2), as amended by Regulation (EC) No 1783/2003 (3), lays down that the Community contribution to agri-environmental measures may not exceed 85 % in areas covered by Objective 1 and 60 % in the other areas.

(2)

Article 47a(3) of Regulation (EC) No 1257/1999, which lays down specific financial provisions for the Member States which acceded on 1 May 2004, specifies that Article 47 of that Regulation does not apply to the financing of the measures referred to in Article 47a(1), which include agri-environmental measures. For those measures, the Community financial contribution may amount to 80 % in areas covered by Objective 1, in accordance with Article 47b(1).

(3)

In order to prevent any difference in treatment between the Member States that made up the Community at 30 April 2004 and the Member States which joined on 1 May 2004 as regards the financing of agri-environmental measures in the areas covered by Objective 1, the rate of the financial contribution applicable to the latter should be brought into line with that applicable to the former as from the date of accession, in accordance with the third indent of the second subparagraph of Article 47(2) of Regulation (EC) No 1257/1999.

(4)

Article 47(2), second subparagraph, first and second indent, of Regulation (EC) No 1257/1999 lays down the Community contribution rate in the areas outside Objective 1 and 2. In accordance with Article 47a, paragraph 3 of Regulation (EC) No 1257/1999 as modified by the 2003 Act of accession, these provisions do not apply to the Member States that joined the European Union on 1 May 2004 in that they only had areas subject to Objective 1 and Objective 2. Since then, it has become clear that some of these Member States, such as Slovakia, also have areas outside the said objectives, where the rural development measures might apply. Under these circumstances, it is necessary to make applicable to the Member States that joined the European Union on 1 May 2004 the provisions of Regulation (EC) No 1257/1999 laying down the Community contribution rate for the measures covered by the rural development programme.

(5)	Regulation (EC) No 1257/1999 should be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 47a(3) of Regulation (EC) No 1257/1999 point (b) shall be replaced by the following:

‘(b)	Article 35(1), Article 35(2), second indent, Article 36(2) and Article 47, with the exception of the second subparagraph of paragraph 2, of this Regulation.’

Article 2

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

It shall apply from 1 May 2004.

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(1)  Opinion of 14.12.2004 (not yet published in the Official Journal).

(2)  OJ L 160, 26.6.1999, p. 80. Regulation as last amended by Regulation (EC) No 583/2004 (OJ L 91, 30.3.2004, p. 1).

(3)  OJ L 270, 21.10.2003, p. 70.

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24.12.2004

EN

Official Journal of the European Union

L 379/3

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COMMISSION REGULATION (EC) No 2224/2004

of 23 December 2004

establishing the standard import values for determining the entry price of certain fruit and vegetables

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof,

Whereas:

(1)	Regulation (EC) No 3223/94 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto.

(2)	In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regulation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 24 December 2004.

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(1)  OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regulation (EC) No 1947/2002 (OJ L 299, 1.11.2002, p. 17).

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24.12.2004

EN

Official Journal of the European Union

L 379/5

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COMMISSION REGULATION (EC) No 2225/2004

of 23 December 2004

fixing the representative prices and the additional import duties for molasses in the sugar sector applicable from 24 December 2004

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1260/2001 of 19 June 2001 on the common organisation of the market in sugar (1), and in particular Article 24(4) thereof,

Whereas:

(1)

Commission Regulation (EC) No 1422/95 of 23 June 1995 laying down detailed rules of application for imports of molasses in the sugar sector and amending Regulation (EEC) No 785/68 (2), stipulates that the cif import price for molasses established in accordance with Commission Regulation (EEC) No 785/68 (3), is to be considered the representative price. That price is fixed for the standard quality defined in Article 1 of Regulation (EEC) No 785/68.

(2)

For the purpose of fixing the representative prices, account must be taken of all the information provided for in Article 3 of Regulation (EEC) No 785/68, except in the cases provided for in Article 4 of that Regulation and those prices should be fixed, where appropriate, in accordance with the method provided for in Article 7 of that Regulation.

(3)	Prices not referring to the standard quality should be adjusted upwards or downwards, according to the quality of the molasses offered, in accordance with Article 6 of Regulation (EEC) No 785/68.

(4)

Where there is a difference between the trigger price for the product concerned and the representative price, additional import duties should be fixed under the terms laid down in Article 3 of Regulation (EC) No 1422/95. Should the import duties be suspended pursuant to Article 5 of Regulation (EC) No 1422/95, specific amounts for these duties should be fixed.

(5)	The representative prices and additional import duties for the products concerned should be fixed in accordance with Articles 1(2) and 3(1) of Regulation (EC) No 1422/95.

(6)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and the additional duties applying to imports of the products referred to in Article 1 of Regulation (EC) No 1422/95 are fixed in the Annex hereto.

Article 2

This Regulation shall enter into force on 24 December 2004.

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(1)  OJ L 178, 30.6.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 39/2004 (OJ L 6, 10.1.2004, p. 16).

(2)  OJ L 141, 24.6.1995, p. 12. Regulation as amended by Regulation (EC) No 79/2003 (OJ L 13, 18.1.2003, p. 4).

(3)  OJ L 145, 27.6.1968, p. 12. Regulation as amended by Regulation (EC) No 1422/95.

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24.12.2004

EN

Official Journal of the European Union

L 379/7

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COMMISSION REGULATION (EC) No 2226/2004

of 23 December 2004

fixing the export refunds on white sugar and raw sugar exported in its unaltered state

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1260/2001 of 19 June 2001 on the common organisation of the markets in the sugar sector (1), and in particular the second subparagraph of Article 27(5) thereof,

Whereas:

(1)	Article 27 of Regulation (EC) No 1260/2001 provides that the difference between quotations or prices on the world market for the products listed in Article 1(1)(a) of that Regulation and prices for those products within the Community may be covered by an export refund.

(2)

Regulation (EC) No 1260/2001 provides that when refunds on white and raw sugar, undenatured and exported in its unaltered state, are being fixed account must be taken of the situation on the Community and world markets in sugar and in particular of the price and cost factors set out in Article 28 of that Regulation. The same Article provides that the economic aspect of the proposed exports should also be taken into account.

(3)

The refund on raw sugar must be fixed in respect of the standard quality. The latter is defined in Annex I, point II, to Regulation (EC) No 1260/2001. Furthermore, this refund should be fixed in accordance with Article 28(4) of that Regulation. Candy sugar is defined in Commission Regulation (EC) No 2135/95 of 7 September 1995 laying down detailed rules of application for the grant of export refunds in the sugar sector (2). The refund thus calculated for sugar containing added flavouring or colouring matter must apply to their sucrose content and, accordingly, be fixed per 1 % of the said content.

(4)	In special cases, the amount of the refund may be fixed by other legal instruments.

(5)	The refund must be fixed every two weeks. It may be altered in the intervening period.

(6)	The first subparagraph of Article 27(5) of Regulation (EC) No 1260/2001 provides that refunds on the products referred to in Article 1 of that Regulation may vary according to destination, where the world market situation or the specific requirements of certain markets make this necessary.

(7)	The significant and rapid increase in preferential imports of sugar from the western Balkan countries since the start of 2001 and in exports of sugar to those countries from the Community seems to be highly artificial.

(8)	To prevent any abuse through the re-import into the Community of sugar products in receipt of an export refund, no refund should be set for all the countries of the western Balkans for the products covered by this Regulation.

(9)	In view of the above and of the present situation on the market in sugar, and in particular of the quotations or prices for sugar within the Community and on the world market, refunds should be set at the appropriate amounts.

(10)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

The export refunds on the products listed in Article 1(1)(a) of Regulation (EC) No 1260/2001, undenatured and exported in the natural state, are hereby fixed to the amounts shown in the Annex hereto.

Article 2

This Regulation shall enter into force on 24 December 2004.

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(1)  OJ L 178, 30.6.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 39/2004 (OJ L 6, 10.1.2004, p. 16).

(2)  OJ L 214, 8.9.1995, p. 16.

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24.12.2004

EN

Official Journal of the European Union

L 379/9

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COMMISSION REGULATION (EC) No 2227/2004

of 23 December 2004

fixing the export refunds on syrups and certain other sugar products exported in the natural state

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1260/2001 of 19 June 2001 on the common organisation of the markets in the sugar sector (1), and in particular the second subparagraph of Article 27(5) thereof,

Whereas:

(1)	Article 27 of Regulation (EC) No 1260/2001 provides that the difference between quotations or prices on the world market for the products listed in Article 1(1)(d) of that Regulation and prices for those products within the Community may be covered by an export refund.

(2)

Article 3 of Commission Regulation (EC) No 2135/95 of 7 September 1995 laying down detailed rules of application for the grant of export refunds in the sugar sector (2), provides that the export refund on 100 kilograms of the products listed in Article 1(1)(d) of Regulation (EC) No 1260/2001 is equal to the basic amount multiplied by the sucrose content, including, where appropriate, other sugars expressed as sucrose; the sucrose content of the product in question is determined in accordance with Article 3 of Commission Regulation (EC) No 2135/95.

(3)

Article 30(3) of Regulation (EC) No 1260/2001 provides that the basic amount of the refund on sorbose exported in the natural state must be equal to the basic amount of the refund less one hundredth of the production refund applicable, pursuant to Commission Regulation (EC) No 1265/2001 of 27 June 2001 laying down detailed rules for the application of Council Regulation (EC) No 1260/2001 as regards granting the production refund on certain sugar products used in the chemical industry (3), to the products listed in the Annex to the last mentioned Regulation.

(4)

According to the terms of Article 30(1) of Regulation (EC) No 1260/2001, the basic amount of the refund on the other products listed in Article 1(1)(d) of the said Regulation exported in the natural state must be equal to one-hundredth of an amount which takes account, on the one hand, of the difference between the intervention price for white sugar for the Community areas without deficit for the month for which the basic amount is fixed and quotations or prices for white sugar on the world market and, on the other, of the need to establish a balance between the use of Community basic products in the manufacture of processed goods for export to third countries and the use of third country products brought in under inward-processing arrangements.

(5)	According to the terms of Article 30(4) of Regulation (EC) No 1260/2001, the application of the basic amount may be limited to some of the products listed in Article 1(1)(d) of the said Regulation.

(6)

Article 27 of Regulation (EC) No 1260/2001 makes provision for setting refunds for export in the natural state of products referred to in Article 1(1)(f) and (g) and (h) of that Regulation; the refund must be fixed per 100 kilograms of dry matter, taking account of the export refund for products falling within CN code 1702 30 91 and for products referred to in Article 1(1)(d) of Regulation (EC) No 1260/2001 and of the economic aspects of the intended exports; in the case of the products referred to in the said Article (1)(f) and (g), the refund is to be granted only for products complying with the conditions in Article 5 of Regulation (EC) No 2135/95; for the products referred to in Article 1(1)(h), the refund shall be granted only for products complying with the conditions in Article 6 of Regulation (EC) No 2135/95.

(7)	The abovementioned refunds must be fixed every month; they may be altered in the intervening period.

(8)	The first subparagraph of Article 27(5) of Regulation (EC) No 1260/2001 provides that refunds on the products referred to in Article 1 of that Regulation may vary according to destination, where the world market situation or the specific requirements of certain markets make this necessary.

(9)	The significant and rapid increase in preferential imports of sugar from the western Balkan countries since the start of 2001 and in exports of sugar to those countries from the Community seems to be highly artificial in nature.

(10)	In order to prevent any abuses associated with the reimportation into the Community of sugar sector products that have qualified for export refunds, refunds for the products covered by this Regulation should not be fixed for all the countries of the western Balkans.

(11)	In view of the above, refunds for the products in question should be fixed at the appropriate amounts.

(12)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

The export refunds on the products listed in Article 1(1)(d), (f), (g) and (h) of Regulation (EC) No 1260/2001, exported in the natural state, shall be set out in the Annex hereto to this Regulation.

Article 2

This Regulation shall enter into force on 24 December 2004.

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(1)  OJ L 178, 30.6.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 39/2004 (OJ L 6, 10.1.2004, p. 6).

(2)  OJ L 214, 8.9.1995, p. 16.

(3)  OJ L 178, 30.6.2001, p. 63.

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24.12.2004

EN

Official Journal of the European Union

L 379/12

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COMMISSION REGULATION (EC) No 2228/2004

of 23 December 2004

fixing the maximum export refund for white sugar to certain third countries for the 15th partial invitation to tender issued within the framework of the standing invitation to tender provided for in Regulation (EC) No 1327/2004

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1260/2001 of 19 June 2001 on the common organisation of the markets in the sugar sector (1) and in particular the second indent of Article 27(5) thereof,

Whereas:

(1)	Commission Regulation (EC) No 1327/2004 of 19 July 2004 on a standing invitation to tender to determine levies and/or refunds on exports of white sugar (2), for the 2004/2005 marketing year, requires partial invitations to tender to be issued for the export of this sugar to certain third countries.

(2)	Pursuant to Article 9(1) of Regulation (EC) No 1327/2004 a maximum export refund shall be fixed, as the case may be, account being taken in particular of the state and foreseeable development of the Community and world markets in sugar, for the partial invitation to tender in question.

(3)	The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Sugar,

HAS ADOPTED THIS REGULATION:

Article 1

For the 15th partial invitation to tender for white sugar issued pursuant to Regulation (EC) No 1327/2004 the maximum amount of the export refund shall be 45,543 EUR/100 kg.

Article 2

This Regulation shall enter into force on 24 December 2004.

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(1)  OJ L 178, 30.6.2001, p. 1. Regulation as last amended by Commission Regulation (EC) No 39/2004 (OJ L 6, 10.1.2004, p. 16).

(2)  OJ L 246, 20.7.2004, p. 23. Regulation as amended by Regulation (EC) No 1685/2004 (OJ L 303, 30.9.2004, p. 21).

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24.12.2004

EN

Official Journal of the European Union

L 379/13

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COMMISSION REGULATION (EC) No 2229/2004

of 3 December 2004

laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC

(Text with EEA relevance)

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), and in particular the second subparagraph of Article 8(2) thereof,

Whereas:

(1)

Directive 91/414/EEC provides for the Commission to undertake a programme of work within a period of 12 years (the programme of work) following the notification of that Directive for the gradual examination of active substances on the market two years after the date of notification of that Directive.

(2)

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 Council Directive 91/414/EEC concerning the placing of plant protection products on the market (2) provides for the first stage of the programme of work and is still ongoing.

(3)

Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC (3) provides for the second stage of the programme of works and is also ongoing.

(4)

Regulation (EC) No 451/2000 also provides for a third stage of the programme of works for an additional number of active substances not covered by the first and second stages of the programme. Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2002 (4) also provides for the third stage of the programme of works. The third stage is also ongoing.

(5)

Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (5) provides for the fourth stage of work and is ongoing. Producers wishing to support the inclusion of the active substances covered by that stage in Annex I to Directive 91/414/EEC have undertaken to provide the necessary information.

(6)

By reason of the accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, it is necessary to provide the opportunity for producers in those new Member States to notify their interest to participate in stage four of the programme of work for all substances covered under that stage. It is also appropriate to organise the review of substances that were on the market in a new Member State before 1 May 2004 and which are not included in stages one to four of the programme of work.

(7)

The procedures established in this Regulation should not prejudice procedures and actions to be undertaken in the framework of other Community legislation, in particular under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances (6), where information becomes available to the Commission showing that its requirements may be satisfied.

(8)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (7) created the European Food Safety Authority (EFSA) to ensure that the Community has access to high-quality, independent and efficient scientific and technical support in order to achieve a high level of health protection in relation to legislation concerning safety of food and feed. It is therefore appropriate to provide that the EFSA should have a role in the programme of work on active substances.

(9)

The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme of work should be laid down, taking into account experience gained during the first and second stages of the programme of work, the objective of separating risk assessment from risk management and the need to organise the work in the most efficient way.

(10)

Close cooperation between producers, Member States, the Commission and the EFSA and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme of work. Strict time limits for all elements of the fourth stage of that programme should be set in order to ensure its finalisation within an acceptable time period. For certain active substances where the dossier requirements are limited, a short deadline for submission of the dossier is appropriate in order to allow the opportunity for further information to be provided within the overall time-frame for completion of the review programme.

(11)	In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.

(12)

It is necessary to define the obligations of producers with regard to the formats, time periods and national authorities and the EFSA for the information to be submitted. Many of the active substances covered by stage four of the programme of work are produced in small volume for specialist purposes. Some are important in organic or other low input farming systems and may be expected to constitute a low risk in terms of human and environmental protection.

(13)

The Commission identified in its progress Report to the European Parliament and the Council — Evaluation of the active substances of plant protection products (submitted in accordance with Article 8(2) of Council Directive 91/414/EEC on the placing of plant protection products on the market) (8) the need for special measures to be adopted in relation to low-risk compounds.

(14)

A modified approach is required for this stage of the programme of work to reduce the risk that large numbers of active substances will be withdrawn for economic reasons alone. For certain groups of active substances it is, therefore, appropriate that the format and requirements for the information to be submitted are different from those developed for active substances in the previous three stages of the programme of work.

(15)

In the interests of consistency of Community legislation it is necessary to ensure that the measures provided for in this Regulation are coherent with measures taken under Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (9).

(16)

The notification and submission of a dossier should not be a prerequisite for the possibility, after inclusion of the active substance in Annex I to Directive 91/414/EEC, to place plant protection products on the market subject to the provisions of Article 13 of that Directive. Therefore persons who have not submitted notifications should be able to be informed at all stages of the evaluation process of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation.

(17)	In order to ensure that all relevant information on the potentially dangerous effects of an active substance or its residues are considered, technical or scientific information submitted within the relevant time limits by any person should also be taken into consideration in the evaluations.

(18)	Where cooperation with notifiers ceases, it is impossible to continue further evaluation efficiently and therefore the evaluation of an active substance should be terminated unless a Member State takes over.

(19)

The task of evaluation should be distributed among the competent authorities of the Member States. Therefore, for each active substance a rapporteur Member State should be designated. Where appropriate the rapporteur Member State should assess the completeness checklist provided by the notifier, and examine and evaluate the information submitted. It should present to the EFSA the results of the evaluation and make a recommendation to the Commission concerning the decision to be taken with regard to the active substance concerned. For certain groups of active substances it is appropriate that the rapporteur Member States closely cooperate with other rapporteur Member States for that group. For each group it is appropriate to identify a lead rapporteur to coordinate such cooperation.

(20)	Rapporteur Member States should send draft assessment reports of their evaluations of active substances to the EFSA. The draft assessment reports should be peer reviewed by the EFSA before they are submitted to the Commission.

(21)	In case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the evaluation and assessment, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State.

(22)	To ensure the proper resourcing of this stage of the programme of work, a fee should be paid to the Member States for the handling and evaluation of dossiers and draft assessment reports.

(23)	The EFSA has been consulted on the proposed measures.

(24)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY

Article 1

Subject matter and scope

1.   This Regulation lays down:

(a)

further detailed rules for the implementation of the fourth stage of the programme of work referred to in the second subparagraph of Article 8(2) of Directive 91/414/EEC (the programme of work) with respect to the continued evaluation of the active substances notified under Regulation (EC) No 1112/2002;

(b)

rules covering the active substances that were on the market before 1 May 2004 in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia and which are not included in stages one to three of the programme of work and which are not covered by Regulation (EC) No 1112/2002.

2.   Article 6(2) and (3) and the second paragraph of Article 6(4) of Directive 91/414/EEC shall not apply to active substances listed in Annex I to this Regulation as long as the procedures provided for in this Regulation with regard to such substances have not been finalised.

3.   This Regulation shall apply without prejudice to:

(a)	reviews by Member States of active substances listed in Annex I to this Regulation in particular pursuant to renewals of authorisations in accordance with Article 4(4) of Directive 91/414/EEC;

(b)	reviews by the Commission in accordance with Article 5(5) of Directive 91/414/EEC;

(c)	assessments carried out under Directive 79/117/EEC.

Article 2

Definitions

For the purpose of this Regulation, the definitions set out in Article 2 of Directive 91/414/EEC and Article 2 of Regulation (EC) No 1112/2002 shall apply.

The following definitions shall also apply:

(a)	‘notifier’ means the natural or legal person who has submitted a notification in accordance with: (i) Regulation (EC) No 1112/2002, as listed in Annex II to this Regulation, or (ii) Article 4 of this Regulation;

(b)	‘rapporteur Member State’ means the rapporteur Member State for the active substance as set out in Annex I.

(c)	‘summary dossier’ means a dossier containing the information required under Article 10(2), where summaries are given of the results of the tests and studies referred to in that paragraph.

(d)	‘complete dossier’ means a dossier containing the information required under Article 10(3), where the results of the tests and study reports referred to in the summary dossier are given in full.

Article 3

Designated Member State authority

1.   Each Member State shall designate an authority or authorities to carry out the obligations of the Member States as defined in this Regulation.

2.   The national authorities listed in Annex III shall coordinate and ensure all necessary contacts with notifiers, other Member States, the Commission and the European Food Safety Authority (EFSA) in accordance with this Regulation.

Each Member State shall give the details concerning the designated coordinating national authority to the Commission, the EFSA and the designated coordinating national authority of each other Member State and inform them of any modifications thereof.

CHAPTER II

NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES

Article 4

Notifications by producers in new Member States

1.   Any producer in a new Member State referred to in Article 1(1)(b) of this Regulation wishing to secure the inclusion in Annex I to Directive 91/414/EEC of an active substance listed in Annex I to this Regulation shall notify the details set out in Annex V of this Regulation to the Commission, other notifiers for that substance and the rapporteur Member State at the latest three months from the date of entry into force of this Regulation.

2.   Any producer making a notification under paragraph 1 shall fulfil the obligations of producers or notifiers set out in this Regulation for the active substance notified.

3.   Where a producer in a new Member State has not submitted a notification for an active substance listed in Annex I to this Regulation, in accordance with paragraph 1, it shall only be permitted to participate in the programme of work collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with paragraph 4 of this Article.

4.   Where no notification has been received for an active substance listed in Annex I to this Regulation, a new Member State may declare its interest in supporting the inclusion of that active substance in Annex I to Directive 91/414/EEC by notifying the Commission and the rapporteur Member State.

That notification must be submitted as soon as possible, and no later than three months from the date the Commission has informed the Member States that no notification has been submitted for that active substance.

A Member State submitting such a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.

5.   The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive active substances referred to in Annex I to this Regulation for which no notification has been submitted in accordance with paragraphs 1 or 4 of this Article. The Decision shall state the reasons for the non-inclusion.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

CHAPTER III

CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES

Article 5

Submission of dossiers by more than one notifier

1.   Where for any active substance listed in Annex I there is more than one notifier, the notifiers concerned shall take all reasonable steps to submit the dossier for such substance collectively.

Where the dossier is not submitted by all such notifiers, it shall contain details of the efforts made and the reasons why certain notifiers have not participated in the submission of the dossier.

2.   Where an active substance has been notified by more than one notifier, those notifiers shall, for each study involving vertebrate animals, give details of the attempts made to avoid duplication of testing and give, if applicable, the reasons for conducting a duplicate study.

Article 6

Submission of dossiers to the rapporteur Member State

1.   The notifier shall submit the dossier for the active substance (the dossier) to the rapporteur Member State.

2.   The dossier shall include the following:

(a)

a copy of the notification; in the case of a collective notification made by more than one producer as referred to in Article 5(1), it shall include: (i) a copy of the notifications made in accordance with Article 4 or 5 of Regulation (EC) No 1112/2002 or Article 4 of this Regulation; (ii) the name of the person designated by the producers concerned as being responsible for the collective notification who will act as a contact point during the procedure;

(b)

a limited range of representative uses of the active substance, in respect of which the data submitted by the notifier in the dossier shall demonstrate that for one or more preparations, the requirements set out in Article 5 of Directive 91/414/EEC for inclusion of the active substance in Annex I to that Directive may be met.

3.   When requested by the rapporteur Member State as provided for in Article 20(2) to circulate the updated summary dossier or where relevant the updated complete dossier or parts thereof the notifier shall do this at the latest one month from the date of receipt of such a request.

Article 7

Dossiers for active substances submitted under Directive 98/8/EC

By derogation from Articles 5 and 6, where an active substance has been notified under Directive 98/8/EC the notifier may submit:

(a)	a copy of the dossier submitted under Directive 98/8/EC;

(b)	any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of that Directive.

Article 8

Dossiers for active substances submitted under Regulation (EC) No 1490/2002

Where a dossier has been submitted under Regulation (EC) No 1490/2002, the person who submitted that dossier may submit, together with the further dossier submitted under this Regulation:

(a)	a reference to the dossier submitted under Regulation (EC) No 1490/2002;

(b)	any additional information referred to in Annexes II and III to Directive 91/414/EEC necessary to justify the inclusion of the active substance in Annex I to that Directive by reference to uses falling within the scope of this Regulation.

Article 9

Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I

1.   Where the dossier concerns an active substance listed in Part A of Annex I, in addition to the information required under Article 5 and Article 6(2), the notifier shall submit the following information concerning the active substance and the plant protection product (where applicable):

(a)	all available information on possible risks to human and animal health and the environment including that available from searching the literature and identifying the data bases searched and search terms used;

(b)	available assessment reports from any OECD country;

(c)	for any ongoing tests and studies not yet fully completed, information on those tests and studies and a projected date of completion.

2.   The dossier shall physically contain the individual test and study reports containing all the information referred to in paragraph 1.

3.   Each Member State shall specify the number of copies of the dossier to be submitted by the notifier when it is acting as a rapporteur and when it receives copies under Article 20(2).

The format of the dossier shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

Article 10

Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I

1.   Where the dossier concerns an active substance listed in Part B to G of Annex I, the notifier shall submit a dossier and a summary dossier.

2.   The notifier(s) shall include in the summarydossier:

(a)	the information required under Article 5 and Article 6(2) of this Regulation;

(b)

for each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive, the summaries and results of tests and studies and the name of the person or institute that has carried out those tests and studies;

(c)	a checklist to be filled in by the notifier, demonstrating that the dossier is complete in accordance with Article 18 of this Regulation.

The tests and studies as referred to in paragraph 2(b) of this Article shall be those relevant to the assessment of the criteria referred to in Article 5 of Directive 91/414/EEC for one or more preparations for the uses taking into account the fact that data gaps in the dossier as regards the information required under Annex II of Directive 91/414/EEC, resulting from the proposed limited range of representative uses of the active substance, may lead to restrictions in the inclusion in Annex I of Directive 91/414/EEC.

3.   The complete dossier shall physically contain the individual test and study reports concerning all the information referred to in point (b) and the second subparagraph of paragraph 2.

4.   Each Member State shall specify the number of copies and the format of the summary and the complete dossiers to be submitted by the notifiers.

In defining the format of the complete and summary dossiers Member States shall take account of the recommendations made in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

Article 11

Submission of information by third parties

Any natural or legal person wishing to submit relevant information which may contribute to the evaluation of an active substance listed in Annex I, in particular with regard to the potentially dangerous effects of that substance or its residues on human and animal health and on the environment, shall do so by the relevant time limit set out in Article 12.

Such information shall be submitted to the rapporteur Member State and the EFSA. When requested by the rapporteur Member State such person shall also submit that information to the other Member States at the latest one month from the date of receipt of such a request.

Article 12

Time limits for submission of dossiers

The notifier(s) shall submit the dossier to the relevant rapporteur Member State by:

(a)	30 June 2005 at the latest for the active substances listed in Part A of Annex I;

(b)	30 November 2005 at the latest for the active substances listed in Parts B to G of Annex I.

Article 13

Non-submission of dossiers

1.   Where the notifier does not submit the dossier or any part thereof within the relevant time limit set out in Article 12, the rapporteur Member State shall inform the Commission and the EFSA within two months of the date of expiry of the time limit, giving any justification for the delay provided by the notifiers.

2.   On the basis of the information submitted by the rapporteur Member State in accordance with paragraph 1, the Commission shall determine whether the notifier has demonstrated that the delay in the submission of the dossier was caused by force majeure.

In that case, it shall establish a new time limit for the submission of a dossier fulfilling the relevant requirements of Articles 5, 6, 9, and 10 of this Regulation in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

3.   The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include in Annex I to that Directive an active substance for which no dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second subparagraph of paragraph 2 of this Article. The Decision shall state the reasons for the non-inclusion.

Member States shall withdraw authorisations of plant protection products containing such active substances within the period prescribed in the Decision.

Article 14

Replacement or withdrawal of notifier

1.   If a notifier decides to end its participation in the programme of work for an active substance, it shall immediately inform the rapporteur Member State, the Commission, the EFSA and all other notifiers of the active substance concerned of its decision, giving the reasons.

Where a notifier ends its participation or fails to fulfil its obligations under this Regulation, the procedures provided for in Articles 15 to 24 shall be terminated as regards its dossier.

2.   If a notifier agrees with another producer that the notifier shall be replaced for the purposes of further participation in the programme of work under this Regulation, the notifier and such other producer shall inform the rapporteur Member State, the Commission and the EFSA by a common declaration agreeing that such other producer shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24. They shall ensure that the other notifiers for the substance concerned are informed at the same time.

The other producer in this case shall be jointly liable with the original notifier for any fees remaining payable in relation to the notifier's application under the regime established by Member States pursuant to Article 30.

3.   If all notifiers for an active substance end their participation in the programme of work a Member State may choose to act as notifier for the purposes of further participation in the programme of work.

Any Member State wishing to act as a notifier shall inform the rapporteur Member State, the Commission and the EFSA at the latest one month from the date of being informed that all notifiers have decided to end their participation and shall replace the original notifier in carrying out the notifier’s duties pursuant to the relevant provisions of Articles 4, 5, 6, 9, 10, 12 and 24.

4.   All information submitted shall remain available to the rapporteur Member States, the Commission and EFSA

CHAPTER IV

EVALUATIONS OF DOSSIERS

Article 15

General Conditions for evaluations of dossiers

1.   Without prejudice to Article 18 the rapporteur Member State shall evaluate all dossiers submitted to it.

2.   Without prejudice to Article 7 of Directive 91/414/EEC, the rapporteur Member State shall not accept the submission of new studies during the evaluation except as provided for in Article 9 (1)(c) of this Regulation.

However, the rapporteur Member State may request the notifier to submit further data which are necessary to clarify the dossier. When doing so the rapporteur Member State shall set a time limit within which the information shall be provided. The time limit shall not affect the time limit for the submission of the draft assessment report by the rapporteur Member State to the EFSA as provided for in Article 21(1) or Article 22(1).

3.   The rapporteur Member State may, from the start of the evaluation of the dossier:

(a)	consult with experts from the EFSA;

(b)	request additional technical or scientific information from other Member States to assist in the evaluation.

4.   Notifiers may seek specific advice from the rapporteur Member State.

Article 16

Cooperation between Member States

1.   The rapporteur Member States shall cooperate in the evaluation within each group set out in Annex I and shall organise such cooperation in the most effective and efficient way.

2.   The rapporteur Member State identified within each group in Annex I as the ‘lead rapporteur’ shall take a lead in organising that cooperation and in organising the provision of advice to notifiers where it concerns matters of general interest to the other Member States concerned.

Article 17

Specific condition for evaluations of active substances listed in Part A of Annex I

Where possible and where it does not affect the time limit for the submission of the draft assessment report as provided for in Article 21(1), the rapporteur Member State shall evaluate further information identified under Article 9(1)(c) subsequently provided by the notifier.

Article 18

Completeness check of dossiers for substances listed in Parts B to G of Annex I

1.   The rapporteur Member State shall assess the checklists provided by the notifiers in accordance with Article 10(2)(c).

2.   The rapporteur Member State shall at the latest three months from the date of receipt of all dossiers for an active substance report to the Commission on the completeness of the dossiers.

3.   For those active substances for which one or more dossiers are considered to be complete, the rapporteur Member State shall perform the evaluation as referred to in Articles 15 and 19, unless the Commission informs the rapporteur Member State, within two months of the date of receipt of the report of the rapporteur Member State on completeness, that it does not consider the dossier to be complete.

4.   For those active substances for which a rapporteur Member State or the Commission consider that no dossier is complete within the meaning of Articles 5, 6 and 10, the Commission shall, within three months from the date of the receipt of the report of the rapporteur Member State on completeness, refer such a report to the Standing Committee for the Food Chain and Animal Health.

In accordance with the procedure referred to in Article 19 of Directive 91/414/EEC it shall be decided whether a dossier is to be considered complete within the meaning of Articles 5, 6 and 10.

5.   The Commission shall decide, as provided for in the fourth subparagraph of Article 8 (2) of Directive 91/414/EEC, not to include in Annex I to Directive 91/414/EEC an active substance for which no complete dossier has been submitted within the time limit provided for in Article 12 of this Regulation or the second sub-paragraph of Article 13 (2).

Article 19

Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I

1.   Where active substances listed in Part D of Annex I to this Regulation have been evaluated under Directive 98/8/EC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation

2.   Where active substances have been evaluated under a former stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC those evaluations shall be taken into account, where relevant, for the purposes of this Regulation.

3.   The rapporteur Member State shall evaluate and report only on those active substances for which at least one dossier has been determined to be complete in accordance with Articles 5, 6, and 10. For dossiers concerning the same active substance not determined to be complete, it shall check whether the identity and impurities of the active substance in those dossiers are comparable to the identity and impurities of the active substance in the dossiers considered complete. It shall record its views on this point in the draft assessment report.

The rapporteur Member State shall take into consideration the information available on potentially dangerous effects in the other dossiers submitted by any notifier or by any third party in accordance with Article 11.

Article 20

General conditions for draft Assessment Reports

1.   The draft assessment report shall be submitted as far as possible in the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

2.   The rapporteur Member State shall request the notifiers to submit an updated summary dossier to the EFSA, the other Member States and on request to the Commission at the same time as the rapporteur's draft assessment report is sent to the EFSA.

The Member States, the Commission or the EFSA may request through the rapporteur Member State that notifiers also send them an updated complete dossier or parts thereof. The notifier shall provide any such updated dossier by the date specified in the request.

Article 21

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I

1.   The rapporteur Member State shall send the draft assessment report to the EFSA as quickly as possible, and 12 months from the date of expiry of the time limit provided for in Article 12(a) at the latest.

2.   The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.

That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name, and if any, the claim made by the holder or notifier for data protection.

3.   At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:

(a)

either to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the proposed conditions for inclusion; such conditions: (i) may include the time limit for such inclusion: (ii) shall state whether any information is required, whether such additional information is included in the tests and studies referred to in Article 9(1)(c) of this Regulation and if so, the probable timetable for the provision of such information; or

(b)	not to include the active substance in Annex I to Directive 91/414/EEC, stating the proposed reasons for the non-inclusion.

4.   In addition to the conditions for inclusion proposed under paragraph 2(a) of this Article, the rapporteur Member State may indicate if it has identified, for the proposed limited range of representative uses mentioned in the dossier, any information missing from the dossier which may be required by Member States as confirmatory information when they come to grant authorisations under Article 4 of Directive 91/414/EEC for plant protection products containing that active substance.

Article 22

Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I

1.   The rapporteur Member State shall send a draft assessment report to the EFSA as quickly as possible, and at the latest 12 months from the date the dossier was determined to be complete in accordance with Article 18(2).

2.   The rapporteur Member State shall include in the draft assessment report a reference to each test or study concerning each point of Annex II (Part A or Part B as appropriate) to Directive 91/414/EEC and for each point of Annex III (Part A or Part B as appropriate) to that Directive relied on for the assessment.

That reference shall be made in the form of a list of test and study reports including the title, the author(s), the date of the study or test report and the date of publication, the standard to which the test or study was conducted, the holder’s name and, if any, the claim made by the holder or notifier for data protection.

3.   At the same time as the rapporteur Member State sends its assessment report to the EFSA as provided for in paragraph 1, it shall make a recommendation to the Commission:

(a)	either to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the inclusion;

(b)	or not to include the active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion.

Article 23

Replacement of rapporteur Member State

1.   A rapporteur Member State shall inform the Commission and the EFSA as soon as it becomes clear that it will be unable to comply with the time limits set out in Articles 21(1) and 22(1) for the submission of the draft assessment report to the EFSA and give the reasons for the delay.

2.   It may be decided to replace a rapporteur Member State for a particular active substance by another Member State where:

(a)	during the assessment and evaluation provided for in Articles 15, 16, 17 and 19 it becomes apparent that there is an imbalance in the responsibilities borne and the work to be done or actually done by the Member States as rapporteurs; or

(b)	it is clear that a Member State is unable to fulfil its obligations under this Regulation.

Such replacement shall be decided in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

3.   Where it has been decided to replace a rapporteur Member State the original rapporteur Member State shall immediately after such a decision has been taken inform 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.

The original Member State shall return to the notifier the part of the fee referred to in Article 30 which has not been used. The newly designated rapporteur Member State may require the payment of a further fee in accordance with Article 30.

Article 24

Evaluation by the EFSA

1.   The EFSA shall, within 30 days of the date of receipt of the draft assessment report as provided for in Article 21(1) or Article 22(1) of this Regulation, check that it clearly complies with the format recommended in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

In exceptional cases where the draft assessment report clearly does not fulfil those requirements the Commission shall agree with the EFSA and the rapporteur Member State on a period for resubmission of an amended report which shall not exceed three months.

2.   The EFSA shall circulate the draft assessment report to the other Member States and to the Commission and may organise a consultation of experts including the rapporteur Member State.

3.   The EFSA may consult some or all of the notifiers of active substances referred to in Annex I on the draft assessment report or parts thereof on the relevant active substances.

4.   Without prejudice to Article 7 of Directive 91/414/EEC, submission of new studies shall not be accepted by the EFSA after receipt of the draft assessment report referred to in paragraph 1 of this Article.

However, the rapporteur Member State, with the agreement of the EFSA, may request the notifiers to submit within specified time limits further data considered by the rapporteur Member State or the EFSA necessary to clarify the dossier.

5.   The EFSA shall make available at specific request or keep available for consultation by any person the following:

(a)	the draft assessment report, except the elements thereof which have been accepted as confidential in accordance with Article 14 of Directive 91/414/EEC;

(b)	the list of any data required for the evaluation of the possible inclusion of the active substance in Annex I to Directive 91/414/EEC, as finalised by the EFSA.

6.   The EFSA shall evaluate the draft assessment report and submit its evaluation to the Commission on whether the active substance may be expected to meet the requirements of Article 5(1) of Directive 91/414/EEC at the latest one year from the date on which it has received both the dossier from the notifier, under Article 15(3) of this Regulation, and also the draft assessment report checked for compliance in accordance with paragraph 1 of this Article.

Where appropriate, the EFSA shall give its evaluation of the available options claimed to meet the requirements of Article 5(1) of Directive 91/414/EEC and any data requirements identified.

The Commission and the EFSA shall agree on a schedule for the submission of the evaluation in order to facilitate the planning of the work. The Commission and the EFSA shall also agree on the format of the evaluation.

CHAPTER V

PRESENTATION OF A DRAFT DIRECTIVE OR DRAFT DECISION CONCERNING ACTIVE SUBSTANCES AND FINALISED REVIEW REPORT

Article 25

Presentation of a draft Directive or draft Decision

1.   The Commission shall present a draft review report at the latest four months from the date of receipt of the EFSA evaluation provided for in Article 24(6)

2.   Without prejudice to any proposal it may submit with a view to amending the Annex to Directive 79/117/EEC, and on the basis of the finalised review report provided for in Article 26 of this Regulation, the Commission shall present to the Standing Committee on the Food Chain and Animal Health:

(a)	a draft Directive to include the active substance in Annex I to Directive 91/414/EEC stating where appropriate the conditions for inclusion; such conditions may include the time limit for such inclusion; or

(b)

a draft Decision addressed to the Member States pursuant to the fourth subparagraph of Article 8(2) of Directive 91/414/EEC, not to include that active substance in Annex I to Directive 91/414/EEC, stating the reasons for the non-inclusion and requiring the Member States to withdraw the authorisations of plant protection products containing the active substance.

The Directive or Decision shall be adopted in accordance with the procedure referred to in Article 19 of Directive 91/414/EEC.

3.   In addition to the conditions for inclusion proposed under paragraph 2(a), the Commission may indicate if it has identified any information missing from the dossier which may be required by Member States when they come to grant authorisations under Article 4 of Directive 91/414/EEC.

Article 26

Finalised review report

The conclusions of the Standing Committee on the Food Chain and Animal Health, excluding any parts which refer to confidential information contained in the dossiers and determined as such in accordance with Article 14 of Directive 91/414/EEC, shall be made publicly available.

CHAPTER VI

SUSPENSION OF TIME LIMITS, MEASURES TO BE TAKEN BY MEMBER STATES AND INTERIM PROGRESS REPORTS

Article 27

Suspension of time limits

Where, in respect of an active substance listed in Annex I to this Regulation, the Commission presents a proposal for a total prohibition by way of a draft Council act based on Article 6(3) of Directive 79/117/EEC, the time limits provided for in this Regulation shall be suspended while the Council considers that proposal.

Where the Council adopts an amendment to the Annex to Directive 79/117/EEC requiring the total prohibition of that active substance, the procedure under this Regulation shall be terminated for that active substance.

Article 28

Measures taken by Member States

Any Member State which, on the basis of information contained in the dossiers referred to in Articles 5 to 10 or in the draft assessment report concerning an active substance referred to in Articles 19 to 22, intends taking action to withdraw that active substance from the market or to restrict severely the use of a plant protection product containing that active substance, shall, as soon as possible, inform the Commission, the EFSA, the other Member States and the notifiers giving the reasons for its intended action.

Article 29

Interim progress report

All Member States shall submit to the Commission and the EFSA a report of their progress on the evaluation of the active substances for which they are rapporteur. Such report shall be submitted by:

(a)	30 November 2005 for the active substances listed in Part A of Annex I;

(b)	30 November 2006 for the active substances listed in Parts B to G of Annex I.

CHAPTER VII

FEES AND OTHER CHARGES

Article 30

Fees

1.   For active substances listed in Annex I Member States may establish a regime obliging the notifiers to pay a fee or charge for the administrative treatment and the evaluation of dossiers.

The income from such fees or charges shall be used to finance exclusively those costs actually incurred by the rapporteur Member State or to finance general activities of the Member States resulting from their obligations under Articles 15 to 24.

2.   Member States shall establish the amount of the fee or charge referred to in paragraph 1 in a transparent manner so that it does not exceed the real cost of the examination and administrative treatment of a dossier or the general activities of the Member States resulting from their obligations under Articles 15 to 24.

However, Member States may provide for a scale of fixed charges based on average costs for the calculation of the total fee.

3.   The fee or charge shall be paid in accordance with the procedure to be established by the authorities in each Member State as listed in Annex IV.

Article 31

Other charges, taxes, levies or fees

Article 30 shall be without prejudice to Member States' rights to maintain or introduce, to the extent permitted under Community law, charges, taxes, levies or fees with regard to authorisation, placing on the market, use and control of active substances and plant protection products other than the fee or charge provided for in that Article.

CHAPTER VIII

TEMPORARY AND FINAL PROVISIONS

Article 32

Temporary measures

If necessary and on a case-by-case basis, the Commission may take appropriate temporary measures as provided for by the third subparagraph of Article 8(2) of Directive 91/414/EEC for uses for which additional technical evidence has been provided demonstrating the essential need for further use of the active substance and that there is no efficient alternative.

Article 33

Entry into force

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

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(1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/71/EC (OJ L 309, 6.10.2004, p. 6).

(2)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

(3)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

(4)  OJ L 224, 21.8.2002, p. 23. Regulation as amended by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).

(5)  OJ L 168, 27.6.2002, p. 14.

(6)  OJ L 33, 8.2.1979, p. 36. Directive as last amended by Regulation (EC) No 850/2004 (OJ L 158, 30.4.2004, p. 7).

(7)  OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation (EC) No 1642/2003 (L 245, 29.9.2003, p. 4).

(8)  COM(2001) 444 final.

(9)  OJ L 123, 24.4.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

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