Consultation Document concerning Registration, Evaluation,

1,92
MB Authorisation and Restrictions of Chemicals (REACH)

200
stron

4757
ID CEFIC, the European Chemical Industry Council

2003
rok

EXECUTIVE SUMMARY

VOLUME 1

Table of contents

Title I General issues – Chapter 1 Subject Matter and Scope – Points 1, 7, 9, 10, 11, 15, 18, 22, 44,

45, 56 3

Title I General issues – Chapter 2 Definitions – Point 2 10

Title II Duty of care – Points 3, 4, 5 16

Title III Information through the supply chain –Points 6

Title IV Registration of substances – Chapters 1 to 6 – Points 7-25 21

Title V Data sharing & avoidance of unnecessary animal testing – Chapters 1 to 3 - Points 26 to 31

44

Title VI Downstream users – Points 32 to 34 51

Title VII Evaluation of substances – Chapters 1 to 3 – Points 35 to 43 55

Title VIII Authorisation - Chapter 1 to 3 - Points 44 to 55 65

Title IX Restrictions on the manufacturing, marketing and use of certain dangerous substances and

preparations – Chapters 1 to 2 - Points 56 to 62 81

Title X Substances in Articles – Points 63 to 64 89

Title XI Agency – Points 65 to 94 92

Title XII Classification & Labelling Inventory – Points 95 to 99 113

Title XIII Information – Points 100 to 102 118

Title XIV Competent Authorities – Points 103 to 106

Title XV Enforcement – Points 107 to 109 124

Title XVI Transitional and final provisions – Points 110 to 117 128

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending for the 8th

time Council Directive 67/548/EEC 133

VOLUME 2

Table of contents

Annex I General Provisions For Assessing Substances And Preparing Chemical Safety Reports 3

Annex II Exemptions From Obligation To Register In Accordance With Point 9 (1) (a) 24

Annex III Exemptions From The Obligation To Register In Accordance With Point 9 (1) (b) 30

Annex IV information requirements referred to in point 11 (1) (a) (i) to (v) 33

Annex V: Standard Information requirements for substances manufactured or imported in quantities

of 1 tonne or more

Annex VI: Standard Information requirements for substances manufactured or imported in quantities

of 10 tonnes or more

Annex VII: Standard Information requirements for substances manufactured or imported in

quantities of 100 tonnes or more

Annex VIII: Standard Information requirements for substances manufactured or imported in

quantities of 1000 tonnes or more

Annex IX: General rules for adaptation of the standard testing regime set out in 40

Annex XI General Provisions for Downstream users to assess substances and prepare chemical

safety reports 110

Annex XII Criteria for the identification of persistent, bioaccumulative and toxic substances, and

very persistent and very bioaccumulative and toxic substances 116

Annex XIV Dossiers 122

- LEGAL ISSUES

1 PROPORTIONALITY PRINCIPLE AND OTHER SIGNIFICANT ISSUES 2

2 INTERNAL MARKET 10

3 DATA PROTECTION RIGHTS 11

4 CONSORTIA AND COMPETITION POLICY COMPLIANCE RELATED ISSUES 13

5 LEGAL CONSEQUENCES OF REACH 14

6 LEGAL RIGHTS AND REMEDIES UNDER THE REACH PROCESSES 16

7 THE ROLE OF THE AGENCY AND MEMBER STATES 19

- SUMMARY OF BUSINESS IMPACT ASSESSMENTS OF NEW CHEMICALS POLICY

- PROPOSED NEW CHEMICALS LEGISLATION AND INTERNATIONAL TRADE/WTO

- OCCUPATIONAL DISEASES IN THE EUROPEAN CHEMICAL INDUSTRY – IMPACT OF REACH



- Business Impact Study - Sectoral Fact Sheets