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Document 02006R1907-20241010
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)
Consolidated text: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Text with EEA relevance)
This consolidated text may not include the following amendments:
Amending act | Amendment type | Subdivision concerned | Date of effect |
---|---|---|---|
32024R2929 | Modified by | annex XVII table point 68 table column 2 point 11 sentence 1 | 18/12/2024 |
32024R2929 | Modified by | annex XVII table point 73 table column 2 point 1 | 18/12/2024 |
32024R2929 | Modified by | annex XVII table point 68 table column 2 point 2 paragraph 2 | 18/12/2024 |
32024R2929 | Modified by | annex XVII table point 68 table column 2 point 10 sentence 1 | 18/12/2024 |
32024R2929 | Modified by | annex XVII table point 73 table column 2 point 4 | 18/12/2024 |
32024R2929 | Modified by | annex XVII table point 68 table column 2 point 10 sentence 2 | 18/12/2024 |
02006R1907 — EN — 10.10.2024 — 062.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396 30.12.2006, p. 1) |
Amended by:
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L 304 |
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22.11.2007 |
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L 268 |
14 |
9.10.2008 |
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REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 |
L 353 |
1 |
31.12.2008 |
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L 46 |
3 |
17.2.2009 |
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L 164 |
7 |
26.6.2009 |
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L 86 |
7 |
1.4.2010 |
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L 133 |
1 |
31.5.2010 |
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L 44 |
2 |
18.2.2011 |
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L 58 |
27 |
3.3.2011 |
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L 69 |
3 |
16.3.2011 |
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L 69 |
7 |
16.3.2011 |
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L 101 |
12 |
15.4.2011 |
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L 134 |
2 |
21.5.2011 |
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L 37 |
1 |
10.2.2012 |
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L 41 |
1 |
15.2.2012 |
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L 128 |
1 |
16.5.2012 |
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L 252 |
1 |
19.9.2012 |
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L 252 |
4 |
19.9.2012 |
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L 253 |
1 |
20.9.2012 |
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L 253 |
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20.9.2012 |
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L 43 |
24 |
14.2.2013 |
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L 108 |
1 |
18.4.2013 |
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L 158 |
1 |
10.6.2013 |
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L 328 |
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L 90 |
1 |
26.3.2014 |
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L 136 |
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21.2.2015 |
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L 58 |
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L 104 |
2 |
23.4.2015 |
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29.5.2015 |
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5.9.2015 |
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L 9 |
1 |
14.1.2016 |
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L 40 |
5 |
17.2.2016 |
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L 144 |
27 |
1.6.2016 |
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L 165 |
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23.6.2016 |
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24.6.2016 |
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21.9.2016 |
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13.12.2016 |
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L 35 |
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L 104 |
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20.4.2017 |
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L 150 |
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14.6.2017 |
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L 150 |
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14.6.2017 |
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L 224 |
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31.8.2017 |
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L 6 |
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11.1.2018 |
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L 99 |
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7 |
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L 114 |
4 |
4.5.2018 |
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L 256 |
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12.10.2018 |
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L 308 |
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4.12.2018 |
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L 322 |
14 |
18.12.2018 |
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L 154 |
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12.6.2019 |
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REGULATION (EU) 2019/1148 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 186 |
1 |
11.7.2019 |
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L 259 |
9 |
10.10.2019 |
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L 35 |
1 |
7.2.2020 |
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L 110 |
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8.4.2020 |
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L 203 |
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26.6.2020 |
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L 252 |
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4.8.2020 |
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L 423 |
6 |
15.12.2020 |
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L 425 |
3 |
16.12.2020 |
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L 431 |
38 |
21.12.2020 |
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L 24 |
19 |
26.1.2021 |
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L 216 |
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18.6.2021 |
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L 259 |
1 |
21.7.2021 |
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L 282 |
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5.8.2021 |
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L 415 |
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22.11.2021 |
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L 418 |
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24.11.2021 |
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14.12.2021 |
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L 98 |
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25.3.2022 |
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L 112 |
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11.4.2022 |
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8.5.2023 |
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L 149 |
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9.6.2023 |
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L 180 |
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17.7.2023 |
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L 238 |
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27.9.2023 |
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L 2482 |
1 |
14.11.2023 |
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L 1328 |
1 |
17.5.2024 |
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L 2462 |
1 |
20.9.2024 |
Corrected by:
REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
(Text with EEA relevance)
TABLE OF CONTENTS |
|
TITLE I |
GENERAL ISSUES |
Chapter 1 |
Aim, scope and application |
Chapter 2 |
Definitions and general provision |
TITLE II |
REGISTRATION OF SUBSTANCES |
Chapter 1 |
General obligation to register and information requirements |
Chapter 2 |
Substances regarded as being registered |
Chapter 3 |
Obligation to register and information requirements for certain types of isolated intermediates |
Chapter 4 |
Common provisions for all registrations |
Chapter 5 |
Transitional provisions applicable to phase-in substances and notified substances |
TITLE III |
DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING |
Chapter 1 |
Objectives and general rules |
Chapter 2 |
Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered |
Chapter 3 |
Rules for phase-in-substances |
TITLE IV |
INFORMATION IN THE SUPPLY CHAIN |
TITLE V |
DOWNSTREAM USERS |
TITLE VI |
EVALUATION |
Chapter 1 |
Dossier evaluation |
Chapter 2 |
Substance evaluation |
Chapter 3 |
Evaluation of intermediates |
Chapter 4 |
Common provisions |
TITLE VII |
AUTHORISATION |
Chapter 1 |
Authorisation requirement |
Chapter 2 |
Granting of authorisations |
Chapter 3 |
Authorisations in the supply chain |
TITLE VIII |
RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES AND ►M3 MIXTURES ◄ |
Chapter 1 |
General issues |
Chapter 2 |
Restrictions process |
TITLE IX |
FEES AND CHARGES |
TITLE X |
AGENCY |
TITLE XII |
INFORMATION |
TITLE XIII |
COMPETENT AUTHORITIES |
TITLE XIV |
ENFORCEMENT |
TITLE XV |
TRANSITIONAL AND FINAL PROVISIONS |
ANNEX I |
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS |
ANNEX II |
REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS |
ANNEX III |
CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES |
ANNEX IV |
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) |
ANNEX V |
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) |
ANNEX VI |
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 |
ANNEX VII |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE |
ANNEX VIII |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE |
ANNEX IX |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE |
ANNEX X |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE |
ANNEX XI |
GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X |
ANNEX XII |
GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS |
ANNEX XIII |
CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES |
ANNEX XIV |
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION |
ANNEX XV |
DOSSIERS |
ANNEX XVI |
SOCIO-ECONOMIC ANALYSIS |
ANNEX XVII |
RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES |
TITLE I
GENERAL ISSUES
CHAPTER 1
Aim, scope and application
Article 1
Aim and scope
Article 2
Application
This Regulation shall not apply to:
radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation ( 1 );
substances, on their own, in a ►M3 mixture ◄ or in an article, which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
non-isolated intermediates;
the carriage of dangerous substances and dangerous substances in dangerous ►M3 mixtures ◄ by rail, road, inland waterway, sea or air.
This Regulation shall apply without prejudice to:
Community workplace and environmental legislation, including Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 3 ), Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control ( 4 ); Directive 98/24/EC, Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( 5 ) and Directive 2004/37/EC;
Directive 76/768/EEC as regards testing involving vertebrate animals within the scope of that Directive.
The provisions of Titles II, V, VI and VII shall not apply to the extent that a substance is used:
in medicinal products for human or veterinary use within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 6 ) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 7 );
in food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
as a food additive in foodstuffs within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption ( 8 );
as a flavouring in foodstuffs within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ( 9 ) and Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council ( 10 );
as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 11 );
in animal nutrition within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition ( 12 ).
The provisions of Title IV shall not apply to the following ►M3 mixtures ◄ in the finished state, intended for the final user:
medicinal products for human or veterinary use, within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC;
cosmetic products as defined in Directive 76/768/EEC;
medical devices which are invasive or used in direct physical contact with the human body in so far as Community measures lay down provisions for the classification and labelling of dangerous substances and ►M3 mixtures ◄ which ensure the same level of information provision and protection as Directive 1999/45/EC;
food or feedingstuffs in accordance with Regulation (EC) No 178/2002 including use:
as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
as an additive in feedingstuffs within the scope of Regulation (EC) No 1831/2003;
in animal nutrition within the scope of Directive 82/471/EEC.
The following shall be exempted from Titles II, V and VI:
substances included in Annex IV, as sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties;
substances covered by Annex V, as registration is deemed inappropriate or unnecessary for these substances and their exemption from these Titles does not prejudice the objectives of this Regulation;
substances on their own or in ►M3 mixtures ◄ , registered in accordance with Title II, exported from the Community by an actor in the supply chain and re-imported into the Community by the same or another actor in the same supply chain who shows that:
the substance being re-imported is the same as the exported substance;
he has been provided with the information in accordance with Articles 31 or 32 relating to the exported substance;
substances, on their own, in ►M3 mixtures ◄ or in articles, which have been registered in accordance with Title II and which are recovered in the Community if:
the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and
the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery.
On-site isolated intermediates and transported isolated intermediates shall be exempted from:
Chapter 1 of Title II, with the exception of Articles 8 and 9; and
Title VII.
CHAPTER 2
Definitions and general provision
Article 3
Definitions
For the purposes of this Regulation:
substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
►M3 mixture ◄ : means a mixture or solution composed of two or more substances;
article: means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
producer of an article: means any natural or legal person who makes or assembles an article within the Community;
polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:
a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
less than a simple weight majority of molecules of the same molecular weight.
In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;
monomer: means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;
registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance;
manufacturing: means production or extraction of substances in the natural state;
manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community;
import: means the physical introduction into the customs territory of the Community;
importer: means any natural or legal person established within the Community who is responsible for import;
placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;
downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a ►M3 mixture ◄ , in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user;
distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a ►M3 mixture ◄ , for third parties;
intermediate: means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis):
non-isolated intermediate: means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
on-site isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and where the manufacture of the intermediate and the synthesis of (an)other substance(s) from that intermediate take place on the same site, operated by one or more legal entities;
transported isolated intermediate: means an intermediate not meeting the criteria of a non-isolated intermediate and transported between or supplied to other sites;
site: means a single location, in which, if there is more than one manufacturer of (a) substance(s), certain infrastructure and facilities are shared;
actors in the supply chain: means all manufacturers and/or importers and/or downstream users in a supply chain;
Agency: means the European Chemicals Agency as established by this Regulation;
competent authority: means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;
phase-in substance: means a substance which meets at least one of the following criteria:
it is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
it was manufactured in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this;
it was placed on the market in the Community, or in the countries acceding to the European Union on 1 January 1995, on 1 May 2004, on 1 January 2007 or on 1 July 2013, by the manufacturer or importer before the entry into force of this Regulation and it was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/EEC in the version of Article 8(1) resulting from the amendment effected by Directive 79/831/EEC, but it does not meet the definition of a polymer as set out in this Regulation, provided the manufacturer or importer has documentary evidence of this, including proof that the substance was placed on the market by any manufacturer or importer between 18 September 1981 and 31 October 1993 inclusive;
notified substance: means a substance for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/EEC;
product and process orientated research and development: means any scientific development related to product development or the further development of a substance, on its own, in ►M3 mixtures ◄ or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance;
scientific research and development: means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year;
use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;
registrant's own use: means an industrial or professional use by the registrant;
full study report: means a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed;
robust study summary: means a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report;
study summary: means a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study;
per year: means per calendar year, unless stated otherwise, for phase-in substances that have been imported or manufactured for at least three consecutive years, quantities per year shall be calculated on the basis of the average production or import volumes for the three preceding calendar years;
restriction: means any condition for or prohibition of the manufacture, use or placing on the market;
supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market;
recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers;
SME: means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 13 );
exposure scenario: means the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate;
use and exposure category: means an exposure scenario covering a wide range of processes or uses, where the processes or uses are communicated, as a minimum, in terms of the brief general description of use;
substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means;
not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities;
alloy: means a metallic material, homogenous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means.
Article 4
General provision
Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third party representative for all proceedings under Article 11, Article 19, Title III and Article 53 involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of a manufacturer or importer or downstream user who has appointed a representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.
TITLE II
REGISTRATION OF SUBSTANCES
CHAPTER 1
General obligation to register and information requirements
Article 5
No data, no market
Subject to Articles 6, 7, 21 and 23, substances on their own, in ►M3 mixtures ◄ or in articles shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions of this Title where this is required.
Article 6
General obligation to register substances on their own or in ►M3 mixtures ◄
Any manufacturer or importer of a polymer shall submit a registration to the Agency for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:
the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);
the total quantity of such monomer substance(s) or other substance(s) makes up one tonne or more per year.
Article 7
Registration and notification of substances in articles
Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:
the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
the substance is intended to be released under normal or reasonably foreseeable conditions of use.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:
the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).
The information to be notified shall include the following:
the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;
the registration number(s) referred to in Article 20(1), if available;
the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;
the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;
a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);
the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.
The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:
the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
the Agency has grounds for suspecting that:
the substance is released from the articles, and
the release of the substance from the articles presents a risk to human health or the environment;
the substance is not subject to paragraph 1.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
Article 8
Only representative of a non-Community manufacturer
Article 9
Exemption from the general obligation to register for product and process orientated research and development (PPORD)
For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Agency of the following information:
the identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex VI;
the identity of the substance, as specified in section 2 of Annex VI;
the classification of the substance as specified in section 4 of Annex VI, if any;
the estimated quantity as specified in section 3.1 of Annex VI;
the list of customers referred to in paragraph 1, including their names and addresses.
The notification shall be accompanied by the fee required in accordance with Title IX.
The period set out in paragraph 1 shall begin at receipt of the notification at the Agency.
In such cases, the Agency may ask the notifier to provide additional necessary information.
When taking decisions as provided for in paragraphs 4 and 7, the Agency shall take into account any comments made by such competent authorities.
Article 10
Information to be submitted for general registration purposes
A registration required by Article 6 or by Article 7(1) or (5) shall include all the following information:
a technical dossier including:
the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI;
the identity of the substance as specified in section 2 of Annex VI;
information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories;
the classification and labelling of the substance as specified in section 4 of Annex VI;
guidance on safe use of the substance as specified in Section 5 of Annex VI;
study summaries of the information derived from the application of Annexes VII to XI;
robust study summaries of the information derived from the application of Annexes VII to XI, if required under Annex I;
an indication as to which of the information submitted under (iii), (iv), (vi), (vii) or subparagraph (b) has been reviewed by an assessor chosen by the manufacturer or importer and having appropriate experience;
proposals for testing where listed in Annexes IX and X;
for substances in quantities of 1 to 10 tonnes, exposure information as specified in section 6 of Annex VI;
a request as to which of the information in Article 119(2) the manufacturer or importer considers should not be made available on the Internet in accordance with Article 77(2)(e), including a justification as to why publication could be harmful for his or any other concerned party's commercial interests.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (vi) and (vii) for the purpose of registration;
a chemical safety report when required under Article 14, in the format specified in Annex I. The relevant sections of this report may include, if the registrant considers appropriate, the relevant use and exposure categories.
Article 11
Joint submission of data by multiple registrants
Subject to paragraph 3, the information specified in Article 10(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter referred to as the lead registrant).
Each registrant shall subsequently submit separately the information specified in Article 10(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10(a)(viii).
The registrants may decide themselves whether to submit the information specified in Article 10(a)(v) and (b) and any relevant indication under Article 10(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.
A registrant may submit the information referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:
it would be disproportionately costly for him to submit this information jointly; or
submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
he disagrees with the lead registrant on the selection of this information.
If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of the disagreement, as the case may be.
Article 12
Information to be submitted depending on tonnage
The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;
the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1 000 tonnes or more per year per manufacturer or importer.
Article 13
General requirements for generation of information on intrinsic properties of substances
Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.
A new registrant shall not refer to such studies in order to provide the information required in Section 2 of Annex VI.
Article 14
Chemical safety report and duty to apply and recommend risk reduction measures
The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a ►M3 mixture ◄ or in an article or a group of substances.
A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than:
the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;
0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.
A chemical safety assessment of a substance shall include the following steps:
human health hazard assessment;
physicochemical hazard assessment;
environmental hazard assessment;
persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1,
or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;
risk characterisation.
The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.
The chemical safety report need not include consideration of the risks to human health from the following end uses:
in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food ( 14 );
in cosmetic products within the scope of Directive 76/768/EEC.
CHAPTER 2
Substances regarded as being registered
Article 15
Substances in plant protection and biocidal products
Article 16
Duties of the Commission, the Agency and registrants of substances regarded as being registered
CHAPTER 3
Obligation to register and information requirements for certain types of isolated intermediates
Article 17
Registration of on-site isolated intermediates
A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:
the identity of the manufacturer as specified in Section 1 of Annex VI;
the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;
the classification of the intermediate as specified in Section 4 of Annex VI;
any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;
a brief general description of the use, as specified in Section 3.5 of Annex VI;
details of the risk management measures applied.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.
The registration shall be accompanied by the fee required in accordance with Title IX.
If these conditions are not fulfilled, the registration shall include the information specified in Article 10.
Article 18
Registration of transported isolated intermediates
A registration for a transported isolated intermediate shall include all the following information:
the identity of the manufacturer or importer as specified in Section 1 of Annex VI;
the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;
the classification of the intermediate as specified in Section 4 of Annex VI;
any available existing information on physicochemical, human health or environmental properties of the intermediate. Where a full study report is available, a study summary shall be submitted;
a brief general description of the use, as specified in Section 3.5 of Annex VI;
information on risk management measures applied and recommended to the user in accordance with paragraph 4.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.
The registration shall be accompanied by the fee required in accordance with Title IX.
For the generation of this information, Article 13 shall apply.
Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:
the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;
procedural and control technologies shall be used that minimise emission and any resulting exposure;
only properly trained and authorised personnel handle the substance;
in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;
substance-handling procedures are well documented and strictly supervised by the site operator.
If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.
Article 19
Joint submission of data on isolated intermediates by multiple registrants
Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘the lead registrant’).
Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).
A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:
it would be disproportionately costly for him to submit this jointly; or
submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
he disagrees with the lead registrant on the selection of this information.
If points (a), (b) or (c) apply, the manufacturer or importer shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment, or the nature of the disagreement, as the case may be.
CHAPTER 4
Common provisions for all registrations
Article 20
Duties of the Agency
The Agency shall undertake the completeness check within three weeks of the submission date, or within three months of the relevant deadline of Article 23, as regards registrations of phase-in substances submitted in the course of the two-month period immediately preceding that deadline.
If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this. The registrant shall complete his registration and submit it to the Agency within the deadline set. The Agency shall confirm the submission date of the further information to the registrant. The Agency shall perform a further completeness check, considering the further information submitted.
The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.
The Agency shall notify the competent authority of the relevant Member State within 30 days of the submission date, that the following information is available in the Agency database:
the registration dossier together with the submission or registration number;
the submission or registration date;
the result of the completeness check; and
any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.
The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.
If the manufacturer has production sites in more than one Member State, the relevant Member State shall be the one in which the head office of the manufacturer is established. The other Member States where the production sites are established shall also be notified.
The Agency shall forthwith notify the competent authority of the relevant Member State(s) when any further information submitted by the registrant is available on the Agency database.
Article 21
Manufacturing and import of substances
In the case of registrations of phase-in substances, such a registrant may continue the manufacture or import of the substance or production or import of an article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the submission date or, if submitted within the two-month period before the relevant deadline of Article 23, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three months from that deadline, without prejudice to Article 27(8).
In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).
Article 22
Further duties of registrants
Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Agency in the following cases:
any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;
any change in the composition of the substance as given in Section 2 of Annex VI;
changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;
new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;
new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;
any change in the classification and labelling of the substance;
any update or amendment of the chemical safety report or Section 5 of Annex VI;
the registrant identifies the need to perform a test listed in Annex IX or Annex X, in which cases a testing proposal shall be developed;
any change in the access granted to information in the registration.
The Agency shall communicate this information to the competent authority of the relevant Member State.
CHAPTER 5
Transitional provisions applicable to phase-in substances and notified substances
Article 23
Specific provisions for phase-in substances
Article 5, Article 6, Article 7(1), Article 17, Article 18 and Article 21 shall not apply until 1 December 2010 to the following substances:
phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007;
phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007;
phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007.
Article 24
Notified substances
TITLE III
DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER 1
Objectives and general rules
Article 25
Objectives and general rules
CHAPTER 2
Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
Article 26
Duty to inquire prior to registration
Every potential registrant of a non-phase-in substance, or potential registrant of a phase-in substance who has not pre-registered in accordance with Article 28, shall inquire from the Agency whether a registration has already been submitted for the same substance. He shall submit all the following information to the Agency with the inquiry:
his identity as specified in Section 1 of Annex VI, with the exception of the use sites;
the identity of the substance, as specified in Section 2 of Annex VI;
which information requirements would require new studies involving vertebrate animals to be carried out by him;
which information requirements would require other new studies to be carried out by him.
Studies involving vertebrate animals shall not be repeated.
The Agency shall simultaneously inform the previous registrants of the name and address of the potential registrant. The available studies shall be shared with the potential registrant in accordance with Article 27.
Article 27
Sharing of existing data in the case of registered substances
Where a substance has previously been registered less than 12 years earlier as referred to in Article 26(3), the potential registrant:
shall, in the case of information involving tests on vertebrate animals; and
may, in the case of information not involving tests on vertebrate animals,
request from the previous registrant(s) the information he requires with respect to Article 10(a)(vi) and (vii) in order to register.
CHAPTER 3
Rules for phase-in-substances
Article 28
Duty to pre-register for phase-in substances
In order to benefit from the transitional regime provided for in Article 23 each potential registrant of a phase-in substance in quantities of one tonne or more per year, including without limitation intermediates, shall submit all the following information to the Agency:
the name of the substance as specified in Section 2 of Annex VI, including its EINECS and CAS number or, if not available, any other identity codes;
his name and address and the name of the contact person and, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in Section 1 of Annex VI;
the envisaged deadline for the registration and the tonnage band;
the name(s) of substance(s) as specified in Section 2 of Annex VI, including their EINECS and CAS number or, if not available, any other identity codes, for which the available information is relevant for the application of Sections 1.3 and 1.5 of Annex XI.
Article 29
Substance Information Exchange Forums
The aim of each SIEF shall be to:
facilitate, for the purposes of registration, the exchange of the information specified in Article 10(a) (vi) and (vii) between potential registrants, thereby avoiding the duplication of studies; and
agree classification and labelling where there is a difference in the classification and labelling of the substance between potential registrants.
Article 30
Sharing of data involving tests
Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it. The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way. This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 77(2)(g). If they cannot reach such an agreement, the cost shall be shared equally. The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment. Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.
TITLE IV
INFORMATION IN THE SUPPLY CHAIN
Article 31
Requirements for safety data sheets
The supplier of a substance or a ►M3 mixture ◄ shall provide the recipient of the substance or ►M3 mixture ◄ with a safety data sheet compiled in accordance with Annex II:
where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or
where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII; or
where a substance is included in the list established in accordance with Article 59(1) for reasons other than those referred to in points (a) and (b).
The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:
in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or
in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or
a substance for which there are Community workplace exposure limits.
The safety data sheet shall be dated and shall contain the following headings:
identification of the substance/ ►M3 mixture ◄ and of the company/undertaking;
hazards identification;
composition/information on ingredients;
first-aid measures;
fire-fighting measures;
accidental release measures;
handling and storage;
exposure controls/personal protection;
physical and chemical properties;
stability and reactivity;
toxicological information;
ecological information;
disposal considerations;
transport information;
regulatory information;
other information.
Any downstream user shall include relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for identified uses.
Any distributor shall pass on relevant exposure scenarios, and use other relevant information, from the safety data sheet supplied to him when compiling his own safety data sheet for uses for which he has passed on information according to Article 37(2).
Suppliers shall update the safety data sheet without delay on the following occasions:
as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
once an authorisation has been granted or refused;
once a restriction has been imposed.
The new, dated version of the information, identified as ‘Revision: (date)’, shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or ►M3 mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.
Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.
From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.
Article 32
Duty to communicate information down the supply chain for substances on their own or in ►M3 mixtures ◄ for which a safety data sheet is not required
Any supplier of a substance on its own or in a ►M3 mixture ◄ who does not have to supply a safety data sheet in accordance with Article 31 shall provide the recipient with the following information:
the registration number(s) referred to in Article 20(3), if available, for any substances for which information is communicated under points (b), (c) or (d) of this paragraph;
if the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
details of any restriction imposed under Title VIII;
any other available and relevant information about the substance that is necessary to enable appropriate risk management measures to be identified and applied including specific conditions resulting from the application of Section 3 of Annex XI.
Suppliers shall update this information without delay on the following occasions:
as soon as new information which may affect the risk management measures, or new information on hazards becomes available;
once an authorisation has been granted or refused;
once a restriction has been imposed.
In addition, the updated information shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or ►M3 mixture ◄ within the preceding 12 months. Any updates following registration shall include the registration number.
Article 33
Duty to communicate information on substances in articles
The relevant information shall be provided, free of charge, within 45 days of receipt of the request.
Article 34
Duty to communicate information on substances and ►M3 mixtures ◄ up the supply chain
Any actor in the supply chain of a substance or a ►M3 mixture ◄ shall communicate the following information to the next actor or distributor up the supply chain:
new information on hazardous properties, regardless of the uses concerned;
any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.
Distributors shall pass on that information to the next actor or distributor up the supply chain.
Article 35
Access to information for workers
Workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or ►M3 mixtures ◄ that they use or may be exposed to in the course of their work.
Article 36
Obligation to keep information
TITLE V
DOWNSTREAM USERS
Article 37
Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures
Distributors shall pass on such information to the next actor or distributor up the supply chain. Downstream users in receipt of such information may prepare an exposure scenario for the identified use(s), or pass the information to the next actor up the supply chain.
For phase-in substances, the manufacturer, importer or downstream user shall comply with this request and with the obligations laid down in Article 14 before the relevant deadline in Article 23 has expired, provided that the downstream user makes his request at least 12 months before the deadline in question.
Where the manufacturer, importer or downstream user, having assessed the use in accordance with Article 14, is unable to include it as an identified use for reasons of protection of human health or the environment, he shall provide the Agency and the downstream user with the reason(s) for that decision in writing without delay and shall not supply downstream user(s) with the substance without including these reason(s) in the information referred to under Articles 31 or 32. The manufacturer or importer shall include this use in Section 3.7 of Annex VI in his update of the registration in accordance with Article 22(1)(d).
A downstream user need not prepare such a chemical safety report in any of the following cases:
a safety data sheet is not required to be communicated with the substance or ►M3 mixture ◄ in accordance with Article 31;
a chemical safety report is not required to be completed by his supplier in accordance with Article 14;
the downstream user uses the substance or ►M3 mixture ◄ in a total quantity of less than one tonne per year;
the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him in the safety data sheet;
the substance is present in a ►M3 mixture ◄ in a concentration lower than any of the concentrations set out in Article 14(2);
the downstream user is using the substance for the purposes of product and process oriented research and development, provided that the risks to human health and the environment are adequately controlled in accordance with the requirements of legislation for the protection of workers and the environment.
Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following:
the safety data sheet(s) supplied to him;
his own chemical safety assessment;
any information on risk management measures supplied to him in accordance with Article 32.
Article 38
Obligation for downstream users to report information
Before commencing or continuing with a particular use of a substance that has been registered by an actor up the supply chain in accordance with Articles 6 or 18, the downstream user shall report to the Agency the information specified in paragraph 2 of this Article, in the following cases:
the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or
the downstream user is relying on the exemptions in Article 37(4)(c) or (f).
The information reported by the downstream user shall include the following:
his identity and contact details as specified in Section 1.1 of Annex VI;
the registration number(s) referred to in Article 20(3), if available;
the identity of the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;
the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI;
a brief general description of the use(s), as specified in Section 3.5 of Annex VI, and of the conditions of use(s);
except where the downstream user is relying on the exemption in Article 37(4)(c), a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.
Article 39
Application of downstream user obligations
TITLE VI
EVALUATION
CHAPTER 1
Dossier evaluation
Article 40
Examination of testing proposals
The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1.
On the basis of the examination under paragraph 1, the Agency shall draft one of the following decisions and that decision shall be taken in accordance with the procedure laid down in Articles 50 and 51:
a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;
a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;
a decision in accordance with points (a), (b) or (d) but requiring registrant(s) or downstream user(s) to carry out one or more additional tests in cases of non-compliance of the testing proposal with Annexes IX, X and XI;
a decision rejecting the testing proposal;
a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days. If the Agency is not informed of such agreement within such 90 days, it shall designate one of the registrants or downstream users, as appropriate, to perform the test on behalf of all of them.
Article 41
Compliance check of registrations
The Agency may examine any registration in order to verify any of the following:
that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;
that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;
that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;
that any explanation(s) submitted in accordance with Article 11(3) or Article 19(2) have an objective basis.
►M57 To check compliance of registration dossiers with this Regulation, the Agency shall select, until 31 December 2023, a percentage of those dossiers no lower than 20 % of the total received by the Agency for registrations in tonnage bands of 100 tonnes or more per year.
The Agency shall, until 31 December 2027, also select a percentage no lower than 20 % of the total received by the Agency for registrations in tonnage bands of less than 100 tonnes per year.
When selecting dossiers for compliance checking, the Agency shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria: ◄
the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or
the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or
the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2).
Article 42
Check of information submitted and follow-up to dossier evaluation
Article 43
Procedure and time periods for examination of testing proposals
In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3):
by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X;
by 1 June 2016 for all registrations received by 1 June 2013 containing proposals for testing in order to fulfil the information requirements in Annex IX only;
by 1 June 2022 for any registrations containing testing proposals received by 1 June 2018.
CHAPTER 2
Substance evaluation
Article 44
Criteria for substance evaluation
In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation. Prioritisation shall be on a risk-based approach. The criteria shall consider:
hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
exposure information;
tonnage, including aggregated tonnage from the registrations submitted by several registrants.
The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as the Member State Committee) and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45.
Article 45
Competent authority
The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available.
If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly.
If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly.
Article 46
Requests for further information and check of information submitted
Article 47
Coherence with other activities
Article 48
Follow-up to substance evaluation
Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1). The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained. The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States.
CHAPTER 3
Evaluation of intermediates
Article 49
Further information on on-site isolated intermediates
For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply. However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:
require the registrant to submit further information directly related to the risk identified. This request shall be accompanied by a written justification;
examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question.
The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein. The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them.
CHAPTER 4
Common provisions
Article 50
Registrants' and downstream users' rights
Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:
where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;
where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.
The procedure in Articles 69 to 73 shall apply mutatis mutandis.
Article 51
Adoption of decisions under dossier evaluation
Article 52
Adoption of decisions under substance evaluation
Article 53
Cost sharing for tests without an agreement between registrants and/or downstream users
Article 54
Publication of information on evaluation
By 28 February of each year, the Agency shall publish on its website a report on the progress made over the previous calendar year towards discharging the obligations incumbent upon it in relation to evaluation. This report shall include, in particular, recommendations to potential registrants in order to improve the quality of future registrations.
TITLE VII
AUTHORISATION
CHAPTER 1
Authorisation requirement
Article 55
Aim of authorisation and considerations for substitution
The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances of very high concern are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
Article 56
General provisions
A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex XIV, unless:
the use(s) of that substance on its own or in a ►M3 mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or
the use(s) of that substance on its own or in a ►M3 mixture ◄ or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or
the date referred to in Article 58(1)(c)(i) has not been reached; or
the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or
in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.
Paragraphs 1 and 2 shall not apply to the following uses of substances:
uses in plant protection products within the scope of Directive 91/414/EEC;
uses in biocidal products within the scope of Directive 98/8/EC;
use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels ( 22 );
uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.
In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:
uses in cosmetic products within the scope of Directive 76/768/EEC;
uses in food contact materials within the scope of Regulation (EC) No 1935/2004.
Paragraphs 1 and 2 shall not apply to the use of substances when they are present in ►M3 mixtures ◄ :
for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w);
for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.
Article 57
Substances to be included in Annex XIV
The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;
substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;
substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;
substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;
substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
Article 58
Inclusion of substances in Annex XIV
Whenever a decision is taken to include in Annex XIV substances referred to in Article 57, such a decision shall be taken in accordance with the procedure referred to in Article 133(4). It shall specify for each substance:
the identity of the substance as specified in Section 2 of Annex VI;
the intrinsic property (properties) of the substance referred to in Article 57;
transitional arrangements:
the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as the sunset date) which should take into account, where appropriate, the production cycle specified for that use;
a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;
review periods for certain uses, if appropriate;
uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.
Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:
PBT or vPvB properties; or
wide dispersive use; or
high volumes.
The number of substances included in Annex XIV and the dates specified under paragraph 1 shall also take account of the Agency's capacity to handle applications in the time provided for. The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009. The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.
The Agency shall update its recommendation, taking into account the comments received.
Article 59
Identification of substances referred to in Article 57
CHAPTER 2
Granting of authorisations
Article 60
Granting of authorisations
The Commission shall not consider the risks to human health arising from the use of a substance in a medical device regulated by Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 23 ), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 24 ) or Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 25 ).
Paragraph 2 shall not apply to:
substances meeting the criteria in Article 57(a), (b), (c) or (f) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex I;
substances meeting the criteria in Article 57(d) or (e);
substances identified under Article 57(f) having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties.
If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Committee for Risk Assessment and the Committee for Socio-economic Analysis referred to in Article 64(4)(a) and (b):
the risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
the socio-economic benefits arising from its use and the socio-economic implications of a refusal to authorise as demonstrated by the applicant or other interested parties;
the analysis of the alternatives submitted by the applicant under Article 62(4)(e) or any substitution plan submitted by the applicant under Article 62(4)(f), and any third party contributions submitted under Article 64(2);
available information on the risks to human health or the environment of any alternative substances or technologies.
When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including:
whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;
the technical and economic feasibility of alternatives for the applicant.
The authorisation shall specify:
the person(s) to whom the authorisation is granted;
the identity of the substance(s);
the use(s) for which the authorisation is granted;
any conditions under which the authorisation is granted;
the time-limited review period;
any monitoring arrangement.
Article 61
Review of authorisations
A holder of an authorisation granted in accordance with Article 60 shall submit an update of the analysis of alternatives referred to in Article 62(4)(e), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 62(4)(f). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 60(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio-economic analysis contained in the original application.
If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.
If any other elements of the original application have changed, he shall also submit updates of these element(s).
When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorisation in the context of the review shall be taken in accordance with the procedure referred to in Article 64 applied mutatis mutandis.
Authorisations may be reviewed at any time if:
the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or
new information on possible substitutes becomes available.
The Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 64.
In cases where there is a serious and immediate risk for human health or the environment, the Commission may suspend the authorisation pending the review, taking into account the principle of proportionality.
Article 62
Applications for authorisations
An application for authorisation shall include the following information:
the identity of the substance(s), as referred to in Section 2 of Annex VI;
the name and contact details of the person or persons making the application;
a request for authorisation, specifying for which use(s) the authorisation is sought and covering the use of the substance in ►M3 mixtures ◄ and/or the incorporation of the substance in articles, where this is relevant;
unless already submitted as part of the registration, a chemical safety report in accordance with Annex I covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex XIV;
an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;
where the analysis referred to in point (e) shows that suitable alternatives are available, taking into account the elements in Article 60(5), a substitution plan including a timetable for proposed actions by the applicant.
The application may include:
a socio-economic analysis conducted in accordance with Annex XVI;
a justification for not considering risks to human health and the environment arising either from:
emissions of a substance from an installation for which a permit was granted in accordance with Directive 96/61/EC; or
discharges of a substance from a point source governed by the requirement for prior regulation referred to in Article 11(3)(g) of Directive 2000/60/EC and legislation adopted under Article 16 of that Directive.
Article 63
Subsequent applications for authorisation
Article 64
Procedure for authorisation decisions
The draft opinions shall include the following elements:
Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;
Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.
If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.
If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion. The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate. Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.
CHAPTER 3
Authorisations in the supply chain
Article 65
Obligation of holders of authorisations
Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a ►M3 mixture ◄ , shall include the authorisation number on the label before they place the substance or a ►M3 mixture ◄ containing the substance on the market for an authorised use without prejudice to ►M3 Directive 67/548/EEC and Regulation (EC) No 1272/2008 ◄ ►M3 ————— ◄ . This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9).
Article 66
Downstream users
TITLE VIII
RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, ►M3 MIXTURES ◄ AND ARTICLES
CHAPTER 1
General issues
Article 67
General provisions
CHAPTER 2
Restrictions process
Article 68
Introducing new and amending current restrictions
The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.
Article 69
Preparation of a proposal
The Agency or Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency or Member State under this Regulation. The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives. To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request.
The Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV. Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms. If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt. The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated. The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance.
Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication. The Agency shall invite all interested parties to submit individually or jointly within six months of the date of publication:
comments on dossiers and the suggested restrictions;
a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions. It shall conform to the requirements in Annex XVI.
Article 70
Agency opinion: Committee for Risk Assessment
Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in Article 69(6)(a).
Article 71
Agency opinion: Committee for Socio-economic Analysis
Article 72
Submission of an opinion to the Commission
Article 73
Commission decision
Where the draft amendment diverges from the original proposal or if it does not take the opinions from the Agency into account, the Commission shall annex a detailed explanation of the reasons for the differences.
TITLE IX
FEES AND CHARGES
Article 74
Fees and charges
In the case of Article 6(4), Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2) and Article 18(2), the structure and amount of fees shall take account of the tonnage range of the substance being registered.
In all cases, a reduced fee shall be set for SMEs.
In the case of Article 11(4), the structure and amount of fees shall take into account whether information has been submitted jointly or separately.
In the case of a request made under Article 10(a)(xi), the structure and amount of fees shall take into account the work required by the Agency in assessing the justification.
TITLE X
AGENCY
Article 75
Establishment and review
Article 76
Composition
The Agency shall comprise:
a Management Board, which shall exercise the responsibilities set out in Article 78;
an Executive Director, who shall exercise the responsibilities set out in Article 83;
a Committee for Risk Assessment, which shall be responsible for preparing the opinion of the Agency on evaluations, applications for authorisation, proposals for restrictions and proposals for classification and labelling under ►M3 Title V of Regulation (EC) No 1272/2008 ◄ and any other questions that arise from the operation of this Regulation relating to risks to human health or the environment;
a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances;
a Member State Committee, which shall be responsible for resolving potential divergences of opinions on draft decisions proposed by the Agency or the Member States under Title VI and proposals for identification of substances of very high concern to be subjected to the authorisation procedure under Title VII;
a Forum for Exchange of Information on Enforcement (hereinafter referred to as the Forum) which shall coordinate a network of Member States authorities responsible for enforcement of this Regulation;
a Secretariat, which shall work under the leadership of the Executive Director and provide technical, scientific and administrative support for the Committees and the Forum and ensure appropriate coordination between them. It shall also undertake the work required of the Agency under the procedures for pre-registration, registration and evaluation as well as preparation of guidance, database maintenance and information provision;
a Board of Appeal, which shall decide on appeals against decisions taken by the Agency.
Article 77
Tasks
The Secretariat shall undertake the following tasks:
performing the tasks allotted to it under Title II; including facilitating the efficient registration of imported substances, in a way consistent with the Community's international trading obligations towards third countries;
performing the tasks allotted to it under Title III;
performing the tasks allotted to it under Title VI;
performing the tasks allotted to it under Title VIII;
establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list established in accordance with Regulation (EC) No 1272/2008. ◄ It shall make the information identified in Article 119(1) and (2) in the database(s) publicly available, free of charge, over the Internet, except where a request made under Article 10(a)(xi) is considered justified. The Agency shall make other information in the databases available on request in accordance with Article 118;
making publicly available information as to which substances are being, and have been evaluated within 90 days of receipt of the information at the Agency, in accordance with Article 119(1);
providing technical and scientific guidance and tools where appropriate for the operation of this Regulation in particular to assist the development of chemical safety reports (in accordance with Article 14, Article 31(1) and Article 37(4)) and application of Article 10(a)(viii), Article 11(3) and Article 19(2) by industry and especially by SMEs; and technical and scientific guidance for the application of Article 7 by producers and importers of articles;
providing technical and scientific guidance on the operation of this Regulation for Member State competent authorities and providing support to the helpdesks established by Member States under Title XIII;
providing guidance to stakeholders including Member State competent authorities on communication to the public of information on the risks and safe use of substances, on their own, in ►M3 mixtures ◄ or in articles;
providing advice and assistance to manufacturers and importers registering a substance in accordance with Article 12(1);
preparing explanatory information on this Regulation for other stakeholders;
at the Commission's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries;
keeping a Manual of Decisions and Opinions based on conclusions from the Member State Committee regarding interpretation and implementation of this Regulation;
notification of decisions taken by the Agency;
provision of formats for submission of information to the Agency.
The Committees shall undertake the following tasks:
performing the tasks allotted to them under ►M3 Titles VI to X ◄ ;
at the Executive Director's request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries;
at the Executive Director's request, drawing up an opinion on any other aspects concerning the safety of substances on their own, in ►M3 mixtures ◄ or in articles.
The Forum shall undertake the following tasks:
spreading good practice and highlighting problems at Community level;
proposing, coordinating and evaluating harmonised enforcement projects and joint inspections;
coordinating exchange of inspectors;
identifying enforcement strategies, as well as best practice in enforcement;
developing working methods and tools of use to local inspectors;
developing an electronic information exchange procedure;
liaising with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organisations, as necessary;
examining proposals for restrictions with a view to advising on enforceability.
Article 78
Powers of the Management Board
The Management Board shall appoint the Executive Director pursuant to Article 84 and an accounting officer in accordance with Article 43 of Regulation (EC, Euratom) No 2343/2002.
It shall adopt:
by 30 April each year, the general report of the Agency for the previous year;
by 31 October each year the work programme of the Agency for the coming year;
the final budget of the Agency pursuant to Article 96 before the beginning of the financial year, adjusting it, where necessary, according to the Community contribution and any other revenue of the Agency;
a multiannual work programme, which shall be regularly revised.
It shall adopt the internal rules and procedures of the Agency. These rules shall be made public.
It shall perform its duties in relation to the Agency's budget pursuant to Articles 96, 97 and 103.
It shall exercise disciplinary authority over the Executive Director.
It shall adopt its rules of procedure.
It shall appoint the Chairman, the members and alternates of the Board of Appeal in accordance with Article 89.
It shall appoint the members of the Agency committees as set out in Article 85.
It shall forward annually any information relevant to the outcome of the evaluation procedures in accordance with Article 96(6).
Article 79
Composition of the Management Board
Each Member State shall nominate a member to the Management Board. The members thus nominated shall be appointed by the Council.
Article 80
Chairmanship of the Management Board
Article 81
Meetings of the Management Board
Article 82
Voting of the Management Board
The Management Board shall adopt rules of procedure for voting, including the conditions for a member to vote on behalf of another member. The Management Board shall act by a two-thirds majority of all members with the right to vote.
Article 83
Duties and powers of the Executive Director
The Executive Director shall be the legal representative of the Agency. He shall be responsible for:
the day-to-day administration of the Agency;
managing all the Agency resources necessary for carrying out its tasks;
ensuring that the time-limits laid down in Community legislation for the adoption of opinions by the Agency are complied with;
ensuring appropriate and timely coordination between the Committees and the Forum;
concluding and managing necessary contracts with service providers;
the preparation of the statement of revenue and expenditure and the implementation of the budget of the Agency pursuant to Articles 96 and 97;
all staff matters;
providing the secretariat for the Management Board;
preparing draft opinions of the Management Board concerning the proposed rules of procedure of the Committees and of the Forum;
making arrangements, upon request from the Management Board, for the execution of any further function(s) (within the remit of Article 77) allotted to the Agency by delegation from the Commission;
establishing and maintaining a regular dialogue with the European Parliament;
determining the terms and conditions for use of software packages;
rectifying a decision made by the Agency following an appeal and after consulting the Chairman of the Board of Appeal.
Each year, the Executive Director shall submit the following to the Management Board for approval:
a draft report covering the activities of the Agency in the previous year, including information about the number of registration dossiers received, the number of substances evaluated, the number of applications for authorisation received, the number of proposals for restriction received by the Agency and opined upon, the time taken for completion of the associated procedures, and the substances authorised, dossiers rejected, substances restricted; complaints received and the action taken; an overview of the activities of the Forum;
a draft work-programme for the coming year;
the draft annual accounts;
the draft forecast budget for the coming year;
a draft multiannual work programme.
The Executive Director shall, following approval by the Management Board, forward the work programme for the coming year and the multiannual work programme to the Member States, the European Parliament, the Council and the Commission, and shall have them published.
The Executive Director shall, following approval by the Management Board, forward the Agency's general report to the Member States, the European Parliament, the Council, the Commission, the European Economic and Social Committee and the Court of Auditors, and shall have it published.
Article 84
Appointment of the Executive Director
The Executive Director shall be appointed on the grounds of merit and documented administrative and management skills, as well as his relevant experience in the fields of chemical safety or regulation. The Management Board shall take its decision by a two-thirds majority of all members with a right to vote.
Power to dismiss the Executive Director shall lie with the Management Board, in accordance with the same procedure.
Before being appointed, the candidate selected by the Management Board shall be invited as soon as possible to make a statement before the European Parliament and to answer questions from Members of Parliament.
Article 85
Establishment of the Committees
Members of the Committees shall be appointed for a term of three years which shall be renewable.
The members of the Management Board may not be members of the Committees.
The members of each Committee may be accompanied by advisers on scientific, technical or regulatory matters.
The Executive Director or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Committees and working groups convened by the Agency or its committees as observers. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of the Committee members, or the Management Board.
These rules shall in particular lay down the procedures for replacing members, the procedures for delegating certain tasks to working groups, the creation of working groups and the establishment of a procedure for the urgent adoption of opinions. The Chairman of each Committee shall be an employee of the Agency.
Article 86
Establishment of the Forum
The Forum shall aim to have a broad range of relevant expertise among its members. To this end the Forum may co-opt a maximum of five additional members chosen on the basis of their specific competence. These members shall be appointed for a term of three years, which shall be renewable. Members of the Management Board may not be members of the Forum.
The members of the Forum may be accompanied by scientific and technical advisers.
The Executive Director of the Agency or his representative and representatives of the Commission shall be entitled to attend all the meetings of the Forum and its working groups. Stakeholders may also be invited to attend meetings as observers, as appropriate, at the request of Forum members, or the Management Board.
These rules shall in particular lay down the procedures for appointing and replacing the Chairman, replacing members and the procedures for delegating certain tasks to working groups.
Article 87
Rapporteurs of Committees and use of experts
The Agency shall keep an up-to-date list of experts. The list shall include the experts referred to in the first subparagraph and other experts identified directly by the Secretariat.
The person concerned, or his employer, shall be remunerated by the Agency in accordance with a scale of fees to be included in the financial arrangements established by the Management Board. Where the person concerned fails to fulfil his duties, the Executive Director has the right to terminate or suspend the contract or withhold remuneration.
The provision of services for which there are several potential providers may require a call for an expression of interest:
if the scientific and technical context allows; and
if it is compatible with the duties of the Agency, in particular the need to provide a high level of protection of human health and the environment.
The Management Board shall adopt the appropriate procedures on a proposal from the Executive Director.
Article 88
Qualification and interests
Article 89
Establishment of the Board of Appeal
The Management Board may appoint additional members and their alternates, on recommendation by the Executive Director, following the same procedure, if this is necessary to ensure that the appeals can be processed at a satisfactory rate.
Article 90
Members of the Board of Appeal
Article 91
Decisions subject to appeal
Article 92
Persons entitled to appeal, time-limits, fees and form
Article 93
Examination and decisions on appeal
Article 94
Actions before the Court of First Instance and the Court of Justice
Article 95
Conflicts of opinion with other bodies
Article 96
The budget of the Agency
The revenues of the Agency shall consist of:
a subsidy from the Community, entered in the general budget of the European Communities (Commission Section);
the fees paid by undertakings;
any voluntary contribution from the Member States.
The budgetary authority shall adopt the establishment plan for the Agency.
Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Management Board within a period of six weeks from the date of notification of the project.
Article 97
Implementation of the budget of the Agency
Article 98
Combating fraud
Article 99
Financial rules
The financial rules applicable to the Agency shall be adopted by the Management Board after the Commission has been consulted. They may not depart from Regulation (EC, Euratom) No 2343/2002 unless specifically necessary for the Agency's operation and with the Commission's prior consent.
Article 100
Legal personality of the Agency
Article 101
Liability of the Agency
The Court of Justice shall have jurisdiction in any dispute relating to compensation for such damages.
Article 102
Privileges and immunities of the Agency
The Protocol on the Privileges and Immunities of the European Communities shall apply to the Agency.
Article 103
Staff rules and regulations
Article 104
Languages
Article 105
Duty of confidentiality
Members of the Management Board, members of the Committees and of the Forum, experts and officials and other servants of the Agency, shall be required, even after their duties have ceased, not to disclose information of the kind covered by the duty of professional secrecy.
Article 106
Participation of third countries
The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of third countries to participate in the work of the Agency.
Article 107
Participation of international organisations
The Management Board may, in agreement with the relevant Committee or the Forum, invite representatives of international organisations with interests in the field of chemicals regulation to participate as observers in the work of the Agency.
Article 108
Contacts with stakeholder organisations
The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and relevant stakeholder organisations.
Article 109
Rules on transparency
To ensure transparency, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific or technical information concerning the safety of substances on their own, in ►M3 mixtures ◄ or in articles which is not of a confidential nature.
Article 110
Relations with relevant Community bodies
This Title shall not otherwise affect the competences vested in the European Food Safety Authority.
This Title shall not affect the competences vested in the Advisory Committee on Safety, Hygiene and Health Protection at Work and the European Agency for Health and Safety at Work.
Article 111
Formats and software for submission of information to the Agency
The Agency shall specify formats and make them available free of charge, and software packages and make them available on its website for any submissions to the Agency. Member States, manufactures, importers, distributors or downstream users shall use these formats and packages in their submissions to the Agency pursuant to this Regulation. In particular, the Agency shall make available software tools to facilitate the submission of all information relating to substances registered in accordance with Article 12(1).
For the purposes of registration, the format of the technical dossier referred to in Article 10(a) shall be IUCLID. The Agency shall coordinate the further development of this format with the Organisation for Economic Cooperation and Development to ensure maximum harmonisation.
▼M3 —————
TITLE XII
INFORMATION
Article 117
Reporting
The first report shall be submitted by 1 June 2010.
The first report shall be submitted by 1 June 2011.
The first report shall be submitted by 1 June 2011.
Every five years, the Commission shall publish a general report on:
the experience acquired with the operation of this Regulation, including the information referred to in paragraphs 1, 2 and 3 and;
the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods.
The first report shall be published by 1 June 2012.
Article 118
Access to information
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests of the concerned person:
details of the full composition of a ►M3 mixture ◄ ;
without prejudice to Article 7(6) and Article 64(2), the precise use, function or application of a substance or ►M3 mixture ◄ , including information about its precise use as an intermediate;
the precise tonnage of the substance or ►M3 mixture ◄ manufactured or placed on the market;
links between a manufacturer or importer and his distributors or downstream users.
Where urgent action is essential to protect human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.
Article 119
Electronic public access
The following information held by the Agency on substances whether on their own, in ►M3 mixtures ◄ or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
if applicable, the name of the substance as given in EINECS;
the classification and labelling of the substance;
physicochemical data concerning the substance and on pathways and environmental fate;
the result of each toxicological and ecotoxicological study;
any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
the guidance on safe use provided in accordance with Sections 4 and 5 of Annex VI;
analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.
The following information on substances whether on their own, in ►M3 mixtures ◄ or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
the total tonnage band (i.e. 1 to 10 tonnes, 10 to 100 tonnes, 100 to 1 000 tonnes or over 1 000 tonnes) within which a particular substance has been registered;
the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
information, other than that listed in paragraph 1, contained in the safety data sheet;
the trade name(s) of the substance;
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:
as an intermediate;
in scientific research and development;
in product and process orientated research and development.
Article 120
Cooperation with third countries and international organisations
Notwithstanding Articles 118 and 119, information received by the Agency under this Regulation may be disclosed to any government or national authority of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals ( 31 ) or under Article 181a(3) of the Treaty, provided that both the following conditions are met:
the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
the third party protects the confidential information as mutually agreed.
TITLE XIII
COMPETENT AUTHORITIES
Article 121
Appointment
Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for cooperating with the Commission and the Agency in the implementation of this Regulation. Member States shall place adequate resources at the disposal of the competent authorities to enable them, in conjunction with any other available resources, to fulfil their tasks under this Regulation in a timely and effective manner.
Article 122
Cooperation between competent authorities
The competent authorities shall cooperate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.
Article 123
Communication to the public of information on risks of substances
The competent authorities of the Member States shall inform the general public about the risks arising from substances where this is considered necessary for the protection of human health or the environment. The Agency, in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice, shall provide guidance for the communication of information on the risks and safe use of chemical substances, on their own, in ►M3 mixtures ◄ or in articles, with a view to coordinating Member States in these activities.
Article 124
Other responsibilities
Competent authorities shall submit electronically to the Agency any available information that they hold on substances registered in accordance with Article 12(1) whose dossiers do not contain the full information referred to in Annex VII, in particular whether enforcement or monitoring activities have identified suspicions of risk. The competent authority shall update this information as appropriate.
Member States shall establish national helpdesks to provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in particular in relation to the registration of substances in accordance with Article 12(1), in addition to the operational guidance documents provided by the Agency under Article 77(2)(g).
TITLE XIV
ENFORCEMENT
Article 125
Tasks of the Member States
Member States shall maintain a system of official controls and other activities as appropriate to the circumstances.
Article 126
Penalties for non-compliance
Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 December 2008 and shall notify it without delay of any subsequent amendment affecting them.
Article 127
Report
The report referred to in Article 117(1) shall, in relation to enforcement, include the results of the official inspections, the monitoring carried out, the penalties provided for and the other measures taken pursuant to Articles 125 and 126 during the previous reporting period. The common issues to be covered in the reports shall be agreed by the Forum. The Commission shall make these reports available to the Agency and the Forum.
TITLE XV
TRANSITIONAL AND FINAL PROVISIONS
Article 128
Free movement
Article 129
Safeguard clause
The Commission shall take a decision in accordance with the procedure referred to in Article 133(3) within 60 days of receipt of the information from the Member State. This decision shall either:
authorise the provisional measure for a time period defined in the decision; or
require the Member State to revoke the provisional measure.
Article 130
Statement of reasons for decisions
The competent authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.
Article 131
Amendments to the Annexes
The Annexes may be amended in accordance with the procedure referred to in Article 133(4).
Article 132
Implementing legislation
The measures necessary to put the provisions of this Regulation efficiently into effect shall be adopted in accordance with the procedure referred to in Article 133(3).
Article 133
Committee procedure
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
Article 134
Preparation of establishment of the Agency
For that purpose, until such time as the Executive Director takes up his duties following his appointment by the Management Board of the Agency in accordance with Article 84, the Commission, on behalf of the Agency, and using the budget provided for the latter, may:
appoint personnel, including a person who shall fulfil the administrative functions of the Executive Director on an interim basis; and
conclude other contracts.
Article 135
Transitional measures regarding notified substances
Such substance shall be regarded as being included in the Community rolling action plan in accordance with Article 44(2) of this Regulation and shall be regarded as being chosen in accordance with Article 45(2) of this Regulation by the Member State whose competent authority has requested further information in accordance with Article 7(2) and Article 16(1) of Directive 67/548/EEC.
Article 136
Transitional measures regarding existing substances
The competent authority for the substance shall be the competent authority from the Member State identified as rapporteur in accordance with Article 10(1) of Regulation (EEC) No 793/93 and shall carry out the tasks of Article 46(3) and Article 48 of this Regulation.
A Member State whose rapporteur has not forwarded by 1 June 2008 the risk evaluation and, where appropriate, the strategy for limiting the risks, in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall:
document information on hazard and risk in accordance with Annex XV, Part B of this Regulation;
apply Article 69(4) of this Regulation on the basis of the information referred to in point (a); and
prepare a documentation of how it considers that any other risks identified would need to be addressed by action other than an amendment of Annex XVII of this Regulation.
The information referred to above shall be submitted to the Agency by 1 December 2008.
Article 137
Transitional measures regarding restrictions
By 1 June 2010, the Commission shall, if necessary, prepare a draft amendment to Annex XVII in accordance with either of the following:
any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals for restrictions in accordance with Title VIII of this Regulation but for which a decision under Directive 76/769/EEC has not yet been taken;
any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction or the amendment of restrictions under Directive 76/769/EEC.
Article 138
Review
By 1 June 2019, the Commission shall carry out a review to assess whether or not to extend the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. ►M3 However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014. ◄ When carrying out the review the Commission shall take into account all relevant factors, including:
the costs for manufacturers and importers of drawing up the chemical safety reports;
the distribution of costs between actors in the supply chain and the downstream user;
the benefits for human health and the environment.
On the basis of these reviews, the Commission may, if appropriate, present legislative proposals to extend this obligation.
The Commission may present legislative proposals as soon as a practicable and cost-efficient way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established, and after publishing a report on the following:
the risks posed by polymers in comparison with other substances;
the need, if any, to register certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of human health and the environment on the other.
Article 139
Repeals
Directive 91/155/EEC shall be repealed.
Directives 93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from 1 June 2008.
Directive 93/67/EEC shall be repealed with effect from 1 August 2008.
Directive 76/769/EEC shall be repealed with effect from 1 June 2009.
References to the repealed acts shall be construed as references to this Regulation.
Article 140
Amendment of Directive 1999/45/EC
Article 14 of Directive 1999/45/EC shall be deleted.
Article 141
Entry into force and application
This Regulation shall be binding in its entirety and directly applicable in all Member States.
LIST OF ANNEXES
ANNEX I |
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS |
ANNEX II |
REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS |
ANNEX III |
CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES |
ANNEX IV |
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a) |
ANNEX V |
EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b) |
ANNEX VI |
INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 |
ANNEX VII |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF ONE TONNE OR MORE |
ANNEX VIII |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE |
ANNEX IX |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE |
ANNEX X |
STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN QUANTITIES OF 1 000 TONNES OR MORE |
ANNEX XI |
GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII TO X |
ANNEX XII |
GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS |
ANNEX XIII |
CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES |
ANNEX XIV |
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION |
ANNEX XV |
DOSSIERS |
ANNEX XVI |
SOCIO-ECONOMIC ANALYSIS |
ANNEX XVII |
RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, MIXTURES AND ARTICLES |
ANNEX I
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
0. INTRODUCTION
0.1. The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks. The chemical safety report shall also describe whether and which different nanoforms of substances as characterised in Annex VI are manufactured and imported, including an adequate justification for each information requirement describing when and how information on one form is used to demonstrate safety of other forms. The requirements speof the following hazard classes or categories setcific to nanoforms of a substance in this Annex apply to all nanoforms covered by the registration and without prejudice to requirements applicable to other forms of that substance. This Annex shall also apply adapted as necessary to producers and importers of articles required to make a chemical safety assessment as part of a registration.
0.2. The chemical safety assessment shall be prepared by one or more competent person(s) who have appropriate experience and received appropriate training, including refresher training.
0.3. The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identified uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety assessment shall consider the use of the substance on its own (including any major impurities and additives), in a mixture and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses. The assessment shall address all nanoforms that are covered by the registration. The justifications and conclusions drawn from the assessment shall be relevant to these nanoforms. The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance taking into account implemented and recommended risk management measures and operational conditions.
0.4. Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group or ‘category’ of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group or ‘category’ of substances. The manufacturer or importer shall provide a justification for this. Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance. Similar considerations apply to exposure scenarios and risk management measures.
0.5. The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety report. Available information from assessments carried out under other international and national programmes shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified.
Thus the information to be considered includes information related to the hazards of the substance, the exposure arising from the manufacture or import, the identified uses of the substance, operational conditions and risk management measures applied or recommended to downstream users to be taken into account.
In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information, because risk management measures and operational conditions which are necessary to control a well-characterised risk may also be sufficient to control other potential risks, which will not therefore need to be characterised precisely.
If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading. Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement. While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored. The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration.
0.6. Steps of a chemical safety assessment
0.6.1. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps 1 to 4 in accordance with the respective sections of this Annex:
Human health hazard assessment.
Human health hazard assessment of physicochemical properties.
Environmental hazard assessment.
PBT and vPvB assessment.
0.6.2. In the cases referred to in point 0.6.3 the chemical safety assessment shall also include the following steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:
Exposure assessment.
The generation of exposure scenario(s) (or the identification of relevant use and exposure categories, if appropriate).
Exposure estimation.
Risk characterisation.
0.6.3. Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, and 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;
hazard class 4.1;
hazard class 5.1.
0.6.4. A summary of all the relevant information used in addressing the points above shall be presented under the relevant heading of the Chemical Safety Report (Section 7).
0.7. The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s) implemented for the manufacturer's production, the manufacturer or importer's own use, and those recommended by the manufacturer or importer to be implemented for the identified use(s).
An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These sets of conditions contain a description of both the risk management measures and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.
If the substance is placed on the market, the relevant exposure scenario(s), including the risk management measures and operational conditions shall be included in an annex to the safety data sheet in accordance with Annex II.
0.8. The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. Exposure scenarios may describe the appropriate risk management measures for several individual processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses. Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further mention of Exposure Scenario in this Annex and Annex II includes Exposure Categories if they are developed.
0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate heading of the chemical safety report and a reference shall be made to the justification in the technical dossier. The fact that no information is required shall also be stated in the safety data sheet.
0.10. In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour and tainting, for which the procedures set out in Sections 1 to 6 are impracticable, the risks associated with such effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description and justification of such assessments in the chemical safety report and summarised in the safety data sheet.
0.11. When assessing the risk of the use of one or more substances incorporated into a special ►M3 mixture ◄ (for instance alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account.
0.11.bis When nanoforms are covered by the chemical safety assessment, an appropriate metric for the assessment and presentation of the results in steps 1-6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet. A multiple metric presentation, including mass metric information, is preferable. When possible, a method for reciprocal conversion shall be indicated.
0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall be explained and justified in the chemical safety report.
0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s).
1. HUMAN HEALTH HAZARD ASSESSMENT
1.0. Introduction
1.0.1. The objectives of the human health hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008; and to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL).
1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance and the following groups of effects:
acute effects such as acute toxicity, irritation and corrosivity;
sensitisation;
repeated dose toxicity; and
CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction).
Based on all the available information, other effects shall be considered when necessary.
1.0.3. The hazard assessment shall comprise the following four steps:
Step 1 |
: |
Evaluation of non-human information. |
Step 2 |
: |
Evaluation of human information. |
Step 3 |
: |
Classification and Labelling. |
Step 4 |
: |
Derivation of DNELs. |
The assessment shall address all nanoforms that are covered by the registration.
1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 11.
1.0.5. For any effect for which no relevant information is available, the relevant section shall contain the sentence: ‘This information is not available’. The justification, including reference to any literature search carried out, shall be included in the technical dossier.
1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1.
1.1.
Step 1 : Evaluation of non-human information
1.1.1. The evaluation of non-human information shall comprise:
1.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included. For instance, for acute effects it is usually not possible to establish the quantitative dose (concentration)-response (effect) relationship on the basis of the results of a test conducted in accordance with test methods laid down in a Commission Regulation as specified in Article 13(3). In such cases it suffices to determine whether and to which degree the substance has an inherent capacity to cause the effect.
1.1.3. All non-human information used to assess a particular effect on humans and to establish the dose (concentration) – response (effect) relationship, shall be briefly presented, if possible in the form of a table or tables, distinguishing between in vitro, in vivo and other information. The relevant test results (e.g. ATE, LD50, NO(A)EL or LO(A)EL) and test conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.
1.1.4. If one study is available then a robust study summary should be prepared for that study. If there are several studies addressing the same effect, then, having taken into account possible variables (e.g. conduct, adequacy, relevance of test species, quality of results, etc.), normally the study or studies giving rise to the highest concern shall be used to establish the DNELs and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study being used but also for all studies demonstrating a higher concern than the study being used. It is important irrespective of whether hazards have been identified or not that the validity of the study be considered.
1.2.
Step 2 : Evaluation of human information
If no human information is available, this part shall contain the statement: ‘No human information is available’. However, if human information is available, it shall be presented, if possible in the form of a table.
1.3.
Step 3 : Classification and Labelling
1.3.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Where applicable, Specific Concentration limits resulting from the application of Article 10 of Regulation (EC) No 1272/2008 and Articles 4 to 7 of Directive 1999/45/EC shall be presented and, if they are not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.
The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.
1.3.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrants shall indicate and justify the action or decision he has taken as a result.
1.4.
Step 4 : Identification of DNEL(s)
1.4.1. Based on the outcomes of steps 1 and 2, (a) DNEL(s) shall be established for the substance, reflecting the likely route(s), duration and frequency of exposure. ►M10 For some hazard classes, especially germ cell mutagenicity and carcinogenicity, the available information may not enable a toxicological threshold, and therefore a DNEL, to be established. ◄ If justified by the exposure scenario(s), a single DNEL may be sufficient. However, taking into account the available information and the exposure scenario(s) in Section 9 of the Chemical Safety Report it may be necessary to identify different DNELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via the environment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women) and for different routes of exposure. A full justification shall be given specifying, inter alia, the choice of the information used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance for which the DNEL is valid. If more than one route of exposure is likely to occur, then a DNEL shall be established for each route of exposure and for the exposure from all routes combined. When establishing the DNEL, the following factors shall, inter alia, be taken into account:
the uncertainty arising, among other factors, from the variability in the experimental information and from intra- and inter-species variation;
the nature and severity of the effect;
the sensitivity of the human (sub-)population to which the quantitative and/or qualitative information on exposure applies.
1.4.2. If it is not possible to identify a DNEL, then this shall be clearly stated and fully justified.
2. PHYSICOCHEMICAL HAZARD ASSESSMENT
2.1. The objective of the hazard assessment for physicochemical properties shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008.
2.2. As a minimum, the potential effects to human health shall be assessed for the following physicochemical properties:
If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.
2.3. The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 9.
2.4. For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the substance to cause the effect resulting from the manufacture and identified uses.
2.5. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified.
3. ENVIRONMENTAL HAZARD ASSESSMENT
3.0. Introduction
3.0.1. The objective of the environmental hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008 and to identify the concentration of the substance below which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is known as the Predicted No-Effect Concentration (PNEC).
3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the (1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological activity of sewage treatment systems shall be considered. The assessment of the effects on each of these five environmental spheres shall be presented under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 12. ►M51 The assessment shall address all nanoforms that are covered by the registration. ◄
3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical safety report shall contain the sentence: ‘This information is not available’. The justification, including reference to any literature research carried out, shall be included in the technical dossier. For any environmental sphere for which information is available, but the manufacturer or importer believes that it is not necessary to conduct the hazard assessment, the manufacturer or importer shall present a justification, with reference to pertinent information, under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under heading 12.
3.0.4. The hazard assessment shall comprise the following three steps, which shall be clearly identified as such in the Chemical Safety Report:
Step 1 |
: |
Evaluation of information. |
Step 2 |
: |
Classification and Labelling. |
Step 3 |
: |
Derivation of the PNEC. |
3.1.
Step 1 : Evaluation of information
3.1.1. The evaluation of all available information shall comprise:
3.1.2. When it is not possible to establish the quantitative dose (concentration)-response (effect) relationship, then this should be justified and a semi-quantitative or qualitative analysis shall be included.
3.1.3. All information used to assess the effects on a specific environmental sphere shall be briefly presented, if possible in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test conditions (e.g. test duration, route of administration) and other relevant information shall be presented, in internationally recognised units of measurement for that effect.
3.1.4. All information used to assess the environmental fate of the substance shall be briefly presented, if possible in the form of a table or tables. The relevant test results and test conditions and other relevant information shall be presented, in internationally recognised units of measurement for that effect.
3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there is more than one study addressing the same effect, then the study or studies giving rise to the highest concern shall be used to draw a conclusion and a robust study summary shall be prepared for that study or studies and included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included as part of the technical dossier, not only for the study being used but also for all studies reaching a higher concern than the study being used. For substances where all available studies indicate no hazards an overall assessment of the validity of all studies should be performed.
3.2.
Step 2 : Classification and Labelling
3.2.1. The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified. Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.
The presentation and justification is applied to all nanoforms covered by the registration.
3.2.2. If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.
3.3.
Step 3 : Identification of the PNEC
3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assessment factor expresses the difference between effects values derived for a limited number of species from laboratory tests and the PNEC for the environmental sphere ( 32 ).
3.3.2. If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified.
4. PBT AND VPVB ASSESSMENT
4.0. Introduction
4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.
4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report. The assessment shall address all nanoforms that are covered by the registration:
Step 1 |
: |
Comparison with the Criteria. |
Step 2 |
: |
Emission Characterisation. |
The assessment shall also be summarised in the Safety Data Sheet under heading 12.
4.1. Step 1: Comparison with the criteria
This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.
4.2. Step 2: Emission Characterisation
If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address all nanoforms that are covered by the registration.
5. EXPOSURE ASSESSMENT
5.0. Introduction
The objective of the exposure assessment shall be to make a quantitative and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed. The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4. The assessment shall address all nanoforms that are covered by the registration. The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:
Step 1 |
: |
Generation of exposure scenario(s) or the generation of relevant use and exposure categories. |
Step 2 |
: |
Exposure Estimation. |
Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to the Safety Data Sheet.
5.1.
Step 1 : Development of exposure scenarios
5.1.1. Exposure scenarios as described in Sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of the process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The first assessment will be based on the required minimum and all available hazard information and on the exposure estimation that corresponds to the initial assumptions about the operating conditions and risk management measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that risks to human health and the environment are not adequately controlled, then it is necessary to carry out an iterative process with amendment of one or a number of factors in hazard or exposure assessment with the aim to demonstrate adequate control. The refinement of hazard assessment may require generation of additional hazard information. The refinement of exposure assessment may involve appropriate alteration of the operational conditions or risk management measures in the exposure scenario or more precise exposure estimation. The exposure scenario, resulting from the final iteration (a final exposure scenario), shall be included in the chemical safety report and attached to the safety data sheet in accordance with Article 31.
The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture in the Community and all identified uses.
In particular, an exposure scenario includes, where relevant, a description of:
5.1.2. Where a manufacturer, importer or downstream user applies for an application for an authorisation for a specific use, exposure scenarios need only be developed for that use and the subsequent life-cycle steps.
5.2.
Step 2 : Exposure Estimation