R E A C H
REACH Regulation
Introduction & Basic Requirements
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Legal Framework before REACH
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67/548/EEC
76/769/EEC
1999/45/EC
(EEC) 793/93
(EC) 2037/2000
(EC) 304/2003
(EC) 850/2004
98/8/EC
(EC) 648/2004

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Dangerous Substances Directive
Limitations Directive
Preparations Directive
Existing Substances Regulation
Ozone Depleting Substances Regulation
Export/Import-Regulation
POPs Regulation
Biocides Directive
Detergents Regulation
Notification of new substances
Testing methods, GLP
Classification & Labelling (C&L), SDS
Risk assessment / risk management
Restrictions of marketing and use
Goals
 Unique system for new and existing substances
 Risk management (instead of almost scientific assessment
of risks ending in itself)
 Acceleration of the process
 Shift of responsibility to industry
 Effective measures for substances of major concern
(authorisation)
REACH
 Registration
(substances > 1 tonne)
 Evaluation
(by the Member States)
 Authorisation
(substances of very high concern) &
 Restriction
(the safety net) of
 Chemicals and the Agency to manage the system
REACH Structure (1)
 Title I - General Issues
 Title II - Registration of Substances
 Title III - Data Sharing and Avoidance of
Unnecessary Testing
 Title IV - Information In the Supply Chain
 Title V – Downstream Users
 Title VI - Evaluation
 Title VII – Authorisation
 Title VIII - Restrictions on the manufacturing,
Marketing and Use of Certain Dangerous Substances
and Preparations and Articles
REACH Structure (2)
 Title VIII - Restrictions on the manufacturing,
Marketing and Use of Certain Dangerous
Substances and Preparations and Articles
 Title IX – Fees and Charges
 Title X – Agency

Title XI – Classification and Labelling Inventory
=> CLP Reg.
 Title XII – Information
 Title XIII – Competent Authorities
 Title XIV – Enforcement
 Title XV – Transitional and Final Provisions
REACH Structure (3)
 ANNEX I - General provisions for assessing substances and
preparing chemical safety reports
 ANNEX II - Guide to the compilation of SDSs
 ANNEX III - Criteria for substances registered in quantities
between 1 and 10 tonnes
 ANNEX IV - Exemptions from the obligation to register in
accordance with art. 2(7)(a)
 ANNEX V - Exemptions from the obligation to register in
accordance with art. 2(7)(b)
 ANNEX VI - Information requirements referred to in art. 10
 ANNEX VII - Standard information 1 tonne or more
 ANNEX VIII - Standard information of 10 tonnes or more
REACH Structure (4)
 ANNEX IX - Standard information 100 tonnes or more
 ANNEX X - Standard information 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 PBT and vPvB
 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,
preparations and articles
Subject (Article 1)
Provisions on substances
 Manufacture
 Import
 Placing on the market
 Use
on their own, in preparations or in articles
Scope (Article 2)
 REACH does not cover:
 Radioactive substances
 Substances under customs supervision
 Non-isolated intermediates
 Supports legislation on:
 Occupational safety and health
 Transport of dangerous goods
Instruments
Registration
Evaluation
Authorisation
Annex XIV
Restrictions
Annex XVII
≥1 t/year
≥ 100 t/year
CMR cat. 1&2
76/769/EEC
+
+
substances
of concern
(<100t)
PBTs/vPvBs
+
Equivalent level
of concern
(endocrine
disruptors, …)
 Annex XVII
Registration
 Obligations to register: manufacturer, importer, EU
representative of non-EU manufacturer
General:
Full Dossier

≥ 1 t/yr per M/I
Monomers
 Substances in
articles

Special:
Reduced Dossier
Deemed to be
Registered
Isolated intermediates  Biocides
 Pesticides
 On-site (Art. 17)
 Notified substances
 Transported (Art. 18)
(67/548/EEC)

Exemptions from Registration
 Uses covered by other legislations
 Medicinal products, food additives, flavourings in foodstuff, feeding
stuff additives, animal nutrition, cosmetic products
 Exempted from Registration
 Substances < 1 t / year
 Annex IV (well known substances)
 Annex V (radioactive substances, by-products etc.)
 Polymers (subject to review)
 Non-registered substances < 2% in polymers
 PPORD substances (time limited)
Time table
1.6.2007
P
P
11 years time for registration
0
1.6.2013
≥ 100 t/year
6 years time f. reg.
1.12.2010
P
1.6.2008
1.6.2018
≥ 1 t/year
≥ 1000 t/year
≥ 1 t/year CMR (cat. 1&2)
≥ 100 t/y R50/53
3½ years time f. reg.
≥ 1 t /year non phase-in substances
and not preregistered substances
1
2
3
4
5
6
7
8
9
10
11
12 years
Registration for non-EU manufacturers
• non-EU manufacturers not covered by REACH
• importers or ‘only representatives’ must register, jointly
with other EU manufacturers, importers or only
representatives
• registrants must be located in EU
• industrial associations cannot register on behalf of its
members
Substances in Articles (Art. 7)
 > 1 t/year per article type per M/I
 Not registered further for this use
-
Intended to be released
-
Likely to be released - but not intended
-
Substance of very high concern
-
concentration > 0.1%
-
Quantity released may adversely affect
human health or the environment
Obligation to register
Obligation to notify the Agency
Agency may require registration
Technical Dossier
 Technical Dossier (Art. 10, 12 and Annexes VI to XI) > 1
t /year
 Identity of substance & manufacturer or importer
 Quantity
 Information on identified uses
 Proposed C&L
 Guidance on safe use
 Information on properties (phys-chem., tox., ecotox.)
 Testing proposal if further testing required
Technical Dossier
 Information requirements
Annex VII Annex VIII
Annex IX
> 1 t/yr
x
> 10 t/yr
x
x
> 100 t/yr
x
x
x
> 1000 t/yr
x
x
x
Annex X
CSR
x
x
x
x
Data sharing
Phase-in substances
Pre-registration for phase-in- substances
 Aim: identification of other potential registrants
 deadline for the pre-registration:
1. June 2008 - 1. December 2008
 SIEF (Substance Information Exchange Forum)
 Sharing of available information
 Who will perform new test on behalf of other SIEF
participants?
 Formation of Consortia (sharing of costs)
Information through the
Supply Chain
Manufacturer / Importer
SDSs, Reg.No., etc.
(+ exposure scenarios,
RMM for identified uses)
DU
No SDS required:
Relevant information*
DU
Agency
RMM appropriate?
Unknown uses
confidential
*Relevant information: Reg.No., details on authorisation/restriction,
relevant information for RRM
Safety Data Sheets (Art. 31, Annex II)
 Former Directive 91/155/EEC incorporated in REACH
 Same scope as before + communicator
 Main tool for communicating information downstream
 Duties to pass relevant information down the supply chain
- even if no SDS is required
Content: standard information: intrinsic hazards of
the chemical
Annex: details on identified uses and recommended risk
management measures (RMM) per exposure scenario
Dossier Evaluation
prevent animal
tests + ensure high
quality of tests
Article 39
Examination of testing
proposals
 request to carry out
the tests
ensure high quality of
dossiers submitted
Article 40
Compliance check, esp.
waiving statements
 require information
needed for compliance
Registrants submit information required
Check of information submitted  conclusion
Substance Evaluation
clarify the suspicion of risks
to human health or the
environment of a substance
Rolling Plan !
Article 44
Request for further information
Registrants submit information required
Check of information submitted  conclusion
Authorisation
Substances of very high concern (SVHC):
 Carginogenic cat. 1 or 2 (Dir. 67/548/EEC)
CMR
 Mutagenic cat. 1 or 2 (Dir. 67/548/EEC)
 Toxic for reproduction cat. 1 or 2 (Dir. 67/548/EEC)
PBT
 Persistent, bioaccumulative and toxic (Annex XIII)
vPvB
 Very persistent and very bioaccumulative (Annex XIII)
 Equivalent level of concern, e.g. endocrine distruptors
Authorisation
Nomination of candidate substances (Annex XV dossier) by
MSs or COM
Adoption as Candidates (MSC), ECHA runs “Candidate List”
Consultation process
ECAH proposal to COM
Substances included into Annex XIV (REACH ATP) need to be
authorised for use and placing on the market
Authorisation to be granted when

risk (HH, ENV) from use is adequately controlled or

socio-economic benefits outweigh the risks to HH/ENV
and no suitable alternative exists
Annex XIV
Information specified:

Identity of substance

Identified properties (that lead to authorisation)

Transitional arrangements (already on the market/used):

“Sunset date”

Application date

Review periods

Exemptions
Procedure
Application for continuing
use/placing on market
Continued use allowed until
decision on authorisation
Decision on
Authorisation
(even after
sunset date)
≥ 18 months
Application date
Sunset date
(Prohibition without
Authorisation)
Restrictions
Dir. 76/769/EEC  Annex XVII
New restrictions as ATP of REACH-Reg.



Safety net for community-wide risk management
Based on risk assessment - different from CSR (
regional exposure, aggregated volumes, etc.)
Restrictions apply to all M/Is, DUs, distributors
Scope

Substances on their own, in preparations, in articles

Regardless of any duty to register and of quantity
(unless thresholds specified)

Exempted: substances used for scientific R&D, PPORD <
1tpa, waste
>1 tonne:
M/I gathers
information on
•Properties
•Identified uses
•Safe management
REACH in a nut-shell
Registration
European
Chemicals Agency
Most substances:
No further action
Evaluation
No further action
Industry can be
asked for more info
MS/Agency
Dossier evaluation:
No authorisation
use is not considered
to be adequately
controlled
Authorisation
is granted by
COM
No authorisation
Benefits too small
compared to risks
Suitable substitutes
available
•Of animal testing (mandatory)
•Of compliance (optional)
Substance evaluation:
Risk
assessment
is reviewed
Socioeconomic
benefits and
possibility for
substitution
are weighed
against risk
•Suspicion of risks (optional)
Industry says will be
adequately controlled
Industry: will not be
adequately controlled
Substances needed to
be regulated further
It has very
hazardous
properties
It poses
unacceptable
risks
Authorisation* Restrictions*
by COM
CMR, PBT, vPvB, or
Based
on MS
equivalent serious
dossiers, COM
and irreversible
can decide on
effect and should
RMM,
ban certain
not be used
uses/substances
without
altogether
authorisation
Recent Development
 ECHA in Operation (6/08)
 Pre-Registration (1.12.2008 )
 Restrictions transition to Annex XVII (6/09)
 2nd stage Candidate List
 1st ECHA recommendation on substances subject to
Authorisation (6/09), Annex XIV still empty
 CLP Regulation, C&L Inventory shifted
 Revisions of annexes
 Downstream regulations
5000
0
8655
5526
4638
4409
3262
2632
2434
1926
1388
1275
941
853
715
639
575
535
505
468
403
393
241
234
189
175
153
139
48
39
38
0000
UK
Germany
Netherlands
Italy
France
Ireland
Spain
Poland
Belgium
Finland
Sweden
Czech Rep.
Austria
Bulgaria
Hungary
Romania
Greece
Slovakia
Denmark
Portugal
Norway
Cyprus
Slovenia
Latvia
Lithuania
Estonia
Luxembourg
Liechtenstei
Malta
Iceland
Figures from Pre-registration
Companies: 65,655 (01.12.2008)
22227
0000
5000
00000
00000
0
449374
357975
189131
135607
120129
92080
90156
72973
58548
44038
39760
36697
35494
30536
24477
14818
14394
10484
10295
9323
7546
5189
4641
4430
4063
3375
2613
276
207
00000
Germany
UK
France
Poland
Netherlands
Italy
Ireland
Spain
Belgium
Estonia
Finland
Slovakia
Sweden
Austria
Czech Rep.
Denmark
Portugal
Hungary
Greece
Romania
Bulgaria
Norway
Slovenia
Latvia
Luxembourg
Lithuania
Liechtenstein
Cyprus
Malta
Iceland
Figures from Pre-registration
Substances: 2,750,464 (12.12.2008)
881835
00000
ECHA - Structure
 “Secretariat”

Management Board (MB)

Executive Director

Scientific and technical staff (up to 450)
 “Committees”

Member States Committee (MSC)

Committee for Risk Assessment (RAC)

Committee for Socio-economic Analysis (SEAC)

Forum for Information Exchange on Enforcement (Forum)
 Board of Appeal
 Networks

Network of Helpdesks

Risk Communication Network

Security Officers Network (IT)
ECHA - Tasks
 Registration
 Processing
 Keeping register
 List of pre-registered subtances
 Evaluation
 Dossier Evaluation
 Treatment of Community Rolling Plan for Substance Evaluation
 Authorisation
 Candidate List
 Recommendation for Annex IV
 Processing applications and preparing opinion for COM
 Restrictions
 Preparing opinion for COM draft
ECHA – Tasks
ctd.
 Running C&L Inventory
 Guidance documents
 Provide information about substances
 Communication to public
 Access to REACH-IT
 Helpdesk
 FAQs
http://www.echa.europa.eu/home_en.asp
Contact & Information
Helmut Witzani
+43.1.31304.5611
[email protected]
Umweltbundesamt
www.umweltbundesamt.at
TAIEX WS on EU legislation on chemical products
Baku ■ 7 June 2010
36