USEFUL DOCUMENTS

REACH: Table of Contents REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Of 18 December 2006

(Published in Official Journal of the European Union, 30.12.2006, L 396, 1–849)

Recitals (p 1) (131)

TABLE OF CONTENTS (p 41)

TITLE I: GENERAL ISSUES (p 47)

Chapter 1: Aim, scope and application (p 47)

1	Aim and scope	47
2	Application	48

Chapter 2: Definitions and general provision (p 53)

3	Definitions	53
4	General provision	61

TITLE II: REGISTRATION OF SUBSTANCES (p 62)

Chapter 1: General obligation to register and information requirements (p 62)

5	No data, no market	62
6	General obligation to register substances on their own or in preparations	62
7	Registration and notification of substances in articles	63
8	Only representative of a non-Community manufacturer	66
9	Exemption from the general obligation to register for PPORD	67
10	Information to be submitted for general registration purposes	70
11	Joint submission of data by multiple registrants	72
12	Information to be submitted depending on tonnage	73
13	General requirements for generation of information in intrinsic properties of substances	75
14	Chemical safety report and duty to apply and recommend risk reduction measures	77

Chapter 2: Substances regarded as being registered (p 80)

15	Substances in plant protection and biocidal products	80
16	Duties of the Commission, the Agency and registrants of substances regarded as being registered	81

Chapter 3: Obligation to register and information requirements for certain types of isolated intermediates (p 82)

17	Registration of on-site isolated intermediates	82
18	Registration of transported isolated intermediates	83
19	Joint submission of data on isolated intermediates by multiple registrants	86

Chapter 4: Common provisions for all registrants (p 87)

20	Duties of the Agency	87
21	Manufacturing and import of substances	90
22	Further duties of registrants	91

Chapter 5: Transitional provisions applicable to phase-in substances and notified substances (p 94)

23	Specific provisions for phase-in substances	94
24	Notified substances	95

TITLE III: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING (p 96)

Chapter 1: Objectives and general rules (p 96)

Objectives and general rules

Chapter 2: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered (p 97)

26	Duty to inquire prior to registration	97
27	Sharing of existing data in the case of registered substances	98

Chapter 3: Rules for phase-in-substances (p 101)

28	Duty to pre-register for phase-in substances	101
29	Substance Information Exchange Fora	104
30	Sharing of data involving tests	105

TITLE IV: INFORMATION IN THE SUPPLY CHAIN (p 107)

31	Requirements for safety data sheets	107
32	Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety data sheet is not required	111
33	Duty to communicate information on substances in articles	113
34	Duty to communicate information on substances and preparations up the supply chain	113
35	Access to information for workers	114
36	Obligation to keep information	114

TITLE V: DOWNSTREAM USERS (p 115)

37	Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures	115
38	Obligation for downstream users to report information	119
39	Application of downstream user obligations	120

TITLE VI: EVALUATION (p 121)

Chapter 1: Dossier evaluation (p 121)

40	Examination of testing proposals	121
41	Compliance check of registrations	123
42	Check of information submitted and follow-up to dossier evaluation	125
43	Procedure and time periods for examination of testing proposals	126

Chapter 2: Substance evaluation (p 127)

44	Criteria for substance evaluation	127
45	Competent authority	128
46	Requests for further information and check of information submitted	130
47	Coherence with other activities	131
48	Follow-up to substance evaluation	132

Chapter 3: Evaluation of intermediates (p 132)

Further information on on-site isolated intermediates

132

Chapter 4: Common provisions (p 133)

50	Registrants’ and downstream users’ rights	133
51	Adoption of decisions under dossier evaluation	134
52	Adoption of decisions under substance evaluation	136
53	Cost sharing for tests without an agreement between registrants and/or downstream users	137

TITLE VII: AUTHORISATION (P 138)

Chapter 1: Authorisation requirement (p 138)

55	Aim of authorisation and considerations for substitution	138
56	General provisions	139
57	Substances to be included in Annex XIV	141
58	Inclusion of substances in Annex XIV	143
59	Identification of substances referred to in Article 57	146

Chapter 2: Granting of authorisations (p 148)

60	Granting of authorisations	148
61	Review of authorisations	152
62	Applications for authorisations	155
63	Subsequent applications for authorisation	158
64	Procedure for authorisation decisions	158

TITLE VIII: RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES (p 163)

Chapter 1: General issues (p 163)

General provisions

163

Chapter 2: Restrictions process (p 164)

68	Introducing new and amending current restrictions	164
69	Preparation of a proposal	165
70	Agency opinion: Committee for Risk Assessment	168
71	Agency opinion: Committee for Socio-economic Analysis	169
72	Submission of an opinion to the Commission	170
73	Commission decision	170

TITLE IX: FEES AND CHARGES (P 171)

Fees and charges

171

TITLE X: AGENCY (P 173)

75	Establishment and review	173
76	Composition	173
77	Tasks	175
78	Powers of the Management Board	179
79	Composition of the Management Board	180
80	Chairmanship of the Management Board	181
81	Meetings of the Management Board	181
82	Voting of the Management Board	182
83	Duties and powers of the Executive Director	182
84	Appointment of the Executive Director	185
85	Establishment of the Committees	186
86	Establishment of the Forum	188
87	Rapporteurs of Committees and use of experts	190
88	Qualification and interests	192
89	Establishment of the Board of Appeal	192
90	Members of the Board of Appeal	193
91	Decisions subject to appeal	195
92	Persons entitled to appeal, time-limits, fees and form	195
93	Examination and decisions on appeal	196
94	Actions before the Court of First Instance and the Court of Justice	196
95	Conflicts of opinion with other bodies	197
96	The budget of the Agency	198
97	Implementation of the budget of the Agency	200
98	Combating fraud	201
99	Financial rules	202
100	Legal personality of the Agency	203
101	Liability of the Agency	203
102	Privileges and immunities of the Agency	204
103	Staff rules and regulations	204
104	Languages	205
105	Duty of confidentiality	205
106	Participation of third countries	205
107	Participation of international organisations	206
108	Contacts with stakeholder organisations	206
109	Rules on transparency	206
110	Relations with relevant Community bodies	207
111	Formats and software for submission of information to the Agency	208

TITLE XI: CLASSIFICATION AND LABELLING INVENTORY (p 208)

112	Scope	208
113	Obligation to notify the Agency	209
114	Classification and labelling inventory	211
115	Harmonisation of classification and labelling	212
116	Transitional arrangements	212

TITLE XII: INFORMATION (P 213)

117	Reporting	213
118	Access to information	214
119	Electronic public access	215
120	Cooperation with third countries and international organisations	218

TITLE XIII: COMPETENT AUTHORITIES (P 219)

121	Appointment	219
122	Cooperation between competent authorities	219
123	Communication to the public of information on risks of substances	220
124	Other responsibilities	220

TITLE XIV: ENFORCEMENT (P 221)

125	Tasks of the Member States	221
126	Penalties for non-compliance	221
127	Report	222

TITLE XV: TRANSITIONAL AND FINAL PROVISIONS (p 222)

128	Free movement	222
129	Safeguard clause	223
130	Statement of reasons for decisions	224
131	Amendments to the Annexes	224
132	Implementing legislation	225
133	Committee procedure	225
134	Preparation of establishment of the Agency	226
135	Transitional measures regarding notified substances	226
136	Transitional measures regarding existing substances	227
137	Transitional measures regarding restrictions	229
138	Review	230
139	Repeals	233
140	Amendment of Directive 1999/45/EC	233
141	Entry into force and application	233

LIST OF ANNEXES (P 235)

I	GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS	237
II	GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS	267
III	CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES	294
IV	EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) [MINIMUM RISK]	295
V	EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) [REGISTRATION DEEMED UNNECESSARY OR INAPPROPRIATE]	304
VI	INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 [INFORMATION TO BE SUBMITTED FOR GENERAL REGISTRATION PURPOSES]: GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI	306
VII	STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE	316
VIII	STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE	330
IX	STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNE OR MORE	344
X	STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE	360
XI	GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X	371
XII	GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS	379
XIII	CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES	383
XIV	LIST OF SUBSTANCES SUBJECT TO AUTHORISATION	386
XV	DOSSIERS [CMRs, PBTs, vPvBs, etc.]	387
XVI	SOCIO-ECONOMIC ANALYSIS	392
XVII	RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES	395

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