# 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) (revoked) EU Regulation No 2229/2004 ยท adopted 3 December 2004 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) ## Introductory text 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) (revoked) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter I: SUBJECT MATTER AND SCOPE, DEFINITIONS AND THE DESIGNATED MEMBER STATE AUTHORITY ## 1 Subject matter and scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 3 Designated Member State authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter II: NOTIFICATIONS BY PRODUCERS IN NEW MEMBER STATES OF ACTIVE SUBSTANCES ## 4 Notifications by producers in new Member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter III: CONDITIONS FOR THE SUBMISSION OF DOSSIERS OF ACTIVE SUBSTANCES AND SUBMISSION OF INFORMATION BY THIRD PARTIES ## 5 Submission of dossiers by more than one notifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 6 Submission of dossiers to the rapporteur Member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 7 Dossiers for active substances submitted under Directive 98/8/EC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 8 Dossiers for active substances submitted under Regulation (EC) No 1490/2002 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 9 Specific conditions for submissions of dossiers for active substances listed in Part A of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 10 Specific conditions for submissions of dossiers for active substances listed in Parts B to G of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 11 Submission of information by third parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 12 Time limits for submission of dossiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 13 Non-submission of dossiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 14 Replacement or withdrawal of notifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter IV: EVALUATIONS OF DOSSIERS ## 15 General Conditions for evaluations of dossiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 16 Cooperation between Member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 17 Specific condition for evaluations of active substances listed in Part A of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 18 Completeness check of dossiers for substances listed in Parts B to G of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 19 Specific conditions for evaluations of dossiers for substances listed in Parts B to G of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 20 General conditions for draft Assessment Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 21 Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Part A of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 22 Specific conditions for draft Assessment Reports and Recommendations to the Commission for active substances listed in Parts B to G of Annex I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 23 Replacement of rapporteur Member State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24 Receipt of and access to the draft assessment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24a Evaluation of the draft assessment report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24b Active substances with clear indications that they do not have any harmful effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24c Consultation of the EFSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24d Submission of additional information after the draft assessment report has been submitted to the EFSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24e Withdrawal by notifier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 24f Active substance for which there are clear indications of harmful effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter V: PRESENTATION OF A DRAFT DIRECTIVE OR DRAFT DECISION CONCERNING ACTIVE SUBSTANCES AND FINALISED REVIEW REPORT ## 25 Presentation of a draft directive or draft decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 25a View by the EFSA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 26 Finalised review report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VI: SUSPENSION OF TIME LIMITS, MEASURES TO BE TAKEN BY MEMBER STATES AND INTERIM PROGRESS REPORTS ## 27 Suspension of time limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 28 Measures taken by Member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 29 Interim progress report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VII: FEES AND OTHER CHARGES ## 30 Fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 31 Other charges, taxes, levies or fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Chapter VIII: TEMPORARY AND FINAL PROVISIONS ## 32 Temporary measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 33 Entry into force . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Signature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex I: List of active substances (column A), rapporteur Member States (column B) and notifying producers (code identification) (column C) ## PART A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Group 2.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Group 2.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## GROUP 6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Group 6.1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Group 6.2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## PART G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex III Co-ordinating authority in the Member States (more details are available at the following webside: http://www.europa.eu.int/comm/food/fs/ph_ps/pro/index_en.htm) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex IV Organisations in the Member States to be contacted concerning further details on the payment of the fees referred to in Article 30 and to which such fees have to be paid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex V Details to be notified by producers in new Member States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex VI Criteria for clear indications of no harmful effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## Annex VII Criteria for clear indications of harmful effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ## 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . --- Source: https://www.legislation.gov.uk/eur/2004/2229 (the official version) Page: https://openlegislation.uk/eu-regulation-2004-2229 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.