FEASIBILITY STUDY ON THE RESOURCE REQUIREMENTS FOR A

0,93

MB

CENTRAL ENTITY

164

stron

4387

ID

Deloitte & Touche Management Solutions S.A.

2003

rok

TABLE OF CONTENTS

1. EXECUTIVE SUMMARY.5

1.1. INTRODUCTION5

1.2. BACKGROUND TO THE STUDY.6

1.3. THE REACH SYSTEM 6

1.4. OTHER TASKS OF THE ENTITY 11

1.5. IMPLICATIONS FOR STRUCTURE .12

1.6. RESOURCES AND WORKLOAD.14

1.7. COSTS .15

1.8. TRANSITION AND CONTINUITY .16

1.9. FEES16

1.10. CONCLUSIONS.17

2. INTRODUCTION.21

2.1. THE CHEMICALS WHITE PAPER21

2.2. KEY ELEMENTS OF THE NEW STRATEGY .21

2.3. THE NEED FOR A CENTRAL ENTITY 22

2.4. THE AIM OF THE STUDY22

2.5. METHOD23

2.6. RATIONALE ON THE STRUCTURE OF THE REPORT23

3. STRUCTURE OPTIONS 25

3.1. COMMUNITY AGENCY.25

3.2. ENLARGED ECB27

4. THE PROVISIONS OF THE WHITE PAPER.28

4.1. GENERAL DESCRIPTION.28

4.2. TASKS AND STAFF OF THE CURRENT EUROPEAN CHEMICALS BUREAU.28

4.3. TASKS OF THE FUTURE ENTITY.31

4.4. FUTURE TASKS OF THE MEMBER STATE COMPETENT AUTHORITIES 31

5. DECISION MAKING PROCESSES32

5.1. THE NEED TO SELECT ONE OR MORE DECISION-MAKING PROCESS(ES) 32

5.2. EXISTING DECISION-MAKING PROCESSES .32

5.3. RELEVANT ELEMENTS FOR THE FUTURE DECISION-MAKING PROCESSES.33

6. THE WORKINGS OF THE REACH SYSTEM.37

6.1. PRE-REGISTRATION.37

6.2. REGISTRATION 38

6.3. EVALUATION.41

6.4. AUTHORISATION .45

7. OTHER REACH PROCESSES49

7.1. CLASSIFICATION AND LABELLING49

7.2. ACCELERATED RISK MANAGEMENT 50

7.3. PRIORITISATION 52

7.4. SUMMARY : CATEGORIES OF SUBSTANCES AND RELATED PROCESSES.53

8. OTHER TASKS OF THE ENTITY .55

8.1. DOWNSTREAM USERS 55

8.2. INFORMATION DISTRIBUTION .55

8.3. SUBMISSION 57

8.4. WEB-SITE & NETWORK .58

8.5. DOCUMENT MANAGEMENT SYSTEM .58

8.6. BIOCIDES, TESTING METHODS AND IMPORT/EXPORT.58

8.7. SUPPORT AND MANAGEMENT ACTIVITIES59

9. APPEALS.60

9.1. APPEALS AGAINST DECISIONS BY MEMBER STATES .60

9.2. APPEALS AGAINST DECISIONS/OPINIONS OF THE CENTRAL ENTITY60

9.3. APPEALS AGAINST DECISIONS BY THE COMMISSION.61

10. DIFFERENCES IN STRUCTURE 62

10.1. IMPACT OF THE STRUCTURE ON THE REACH PROCESS62

10.2. IMPORTANT INTANGIBLES FOR THE ENTITY .63

10.3. DIFFERENCES IN STRUCTURE64

11. RESOURCES AND WORKLOAD68

11.1. INTRODUCTION .68

11.2. ASSUMPTIONS.68

11.3. PRE-REGISTRATION .69

11.4. REGISTRATION69

11.5. EVALUATION 70

11.6. AUTHORISATION.71

11.7. ACCELERATED RISK MANAGEMENT 73

11.8. CLASSIFICATION AND LABELLING73

11.9. BIOCIDES/IMPORT-EXPORT/TESTING METHODS/OTHER TASKS73

11.10. MANAGEMENT SUPPORT AND ADMINISTRATIVE TASKS74

11.11. SECONDMENT OF STAFF .76

12. IMPLICATIONS FOR STRUCTURE AND COSTS.77

12.1. INTRODUCTION .77

12.2. OTHER FINANCIAL COSTS DEPENDING ON THE STRUCTURE 84

13. TRANSITION PERIOD AND CONTINUITY .86

13.1. EXPANDED ECB 86

13.2. AGENCY86

14. FEES AND INCENTIVES 87

14.1. THE NEED FOR FEES.87

14.2. FEE LEVEL.87

14.3. INCENTIVES AND DISINCENTIVES .90

15. FINANCIAL MODEL91

15.1. INTRODUCTION .91

15.2. KEY ASSUMPTIONS91

15.3. FINANCIAL MODEL AGENCY SCENARIO 3.92

15.4. FINANCIAL MODEL EXPANDED ECB SCENARIO 3.93

15.5. FINANCIAL MODEL AGENCY SCENARIO 3, ALTERNATIVE OPTION AUTHORISATIONS94

16. CONCLUSIONS .95

16.1. PROCESSES95

16.2. RESOURCES AND COSTS .95

16.3. STRUCTURE.96

16.4. OVERALL 97

17. ANNEXES .99

17.1. ANNEX 1: WORKING ASSUMPTIONS.99

17.2. ANNEX 2: REVIEW OF EXISTING DECISION-MAKING PROCESSES AND IDENTIFICATION

OF RELEVANT ELEMENTS FOR THE IMPLEMENTATION OF THE REACH PROCESSES100

17.3. ANNEX 3: STAFF MODEL110

17.4. ANNEX 4: FINANCIAL MODEL130

17.5. ANNEX 5: COMPETENT AUTHORITY QUESTIONNAIRE .142