Transcript REACH process

Future legislation on chemicals
and REACH processes
Jens Tørsløv
European Chemicals Bureau
Institute for Health and Consumer Protection
Joint Research Centre
Contents
• Why a new Chemicals Policy?
• Main elements of REACH
• REACH main changes
Why a new Chemicals Policy?
General Risk Assessment /
Risk Management process
Identification
of ‘priority’
substances
Data
Generation
Risk
Assessment
Identification
of risk
management
measures
Implementation
of RMMs in
Community
legislation
Legislative context
Biocides
New substances
Existing substances
Directive 92/32/EC
Regulation (EC)793/93
Directive
Directive 93/67/EC
Regulation (EC)1488/94
98/8/EC
1993
1994
2002
Technical Guidance Documents (1996)
2003
Technical Guidance Documents (2003)
Principles for risk assessment
Detailed procedures for risk assessment are given in the
Technical Guidance Documents (TGD):
man
environment
QSARs
emission
scenario
documents
Freely available from the ECB web page
http://ecb.jrc.it/tgdoc
Basic Framework of Risk Assessment
Process
Data evaluation
Exposure assessment
Emission rates
Data set
Effects assessment
Single species
toxicity data
TGD
Extrapolation
Distribution
EUSE
S
PNEC
PEC
Risk characterization
PEC/PNEC
Main successes of current legislation
• Large data gathering and summarising process for
HPVCs
• Agreement on RA principles (TGD/EUSES)
• Agreement on priority setting (HERO)
• EU harmonised risk assessments for many
controversial substances, forming the solid basis
for EU wide risk reduction measures
Main Problems
• Data gaps: 86% of HPVCs have less than base set
data
• The process takes (far) too much time
• Burden of proof is on public authorities
• Generally Downstream Users stay out of the
picture, actual uses of chemicals remain unknown
• The system is inefficient: Industry is faced with a
myriad of directives and regulations
• Administrative burden for new, mostly low volume,
chemicals prevents innovation
REACH
Registration,
Evaluation and
Authorisation of
CHemicals
REACH objective
• Sustainable Development
–
–
–
–
Protection of human health and the environment
Maintain/enhance innovation/competitiveness
Maintain the Internal Market
Increased transparency and consumer
awareness
– Integration with international efforts
– Promotion of non-animal testing
– Conformity to WTO obligations
REACH principle
• Industry ensures manufacturing, placing on the
market and use do not adversely affect human
health or the environment
– Manufacturers and importers assess and
document that risks are adequately controlled
– Manufacturers and importers communicate to
downstream users how to control risks
– Downstream users apply measures to control
risks and communicate this further downstream
The EU accounts for 33% of the World
Chemicals Sales
The EU chemical industry comprises 27 000 enterprises
96% SME; 30% of sales; 37% of employment (1.3 million).
Main elements of REACH
Registration of all substances
> 1 t/yr
Evaluation by
competent authorities
Authorisation of certain
hazardous substances
Scope:
Scope:
• manufacturers, importers,
professional
Scope:
•decisions
for users
additional information
• substances,
in preparations,
in
•carcinogenic,
reprotoxic
•proposal
formutagenic,
authorisation
certain articles
substances
(CMR-substances)
•proposal
for restriction measures
• mandatory data tonnage
•Endocrine disruptors
dependent
•Persistent
bioaccumulating
toxic
• Chemical
safety report
Scope: (PBTs
substances
or vPvBs)
• Safety data
sheet
•
all other substances of high
concern following risk
assessment
Measures for
substances of concern
REACH: KEY ELEMENTS
• Introduces a Single Coherent System for new (non
phase-in) and existing (phase-in) substances
• Key elements:
– Registration by industry of manufactured/imported
chemical substances > 1 tonne/year (staggered deadlines over 11years)
– Increased information and communication throughout the
supply chain
– Evaluation of some registered substances (Agency and
Member States)
– Authorisation only for use of substances of very high
concern
– Restrictions: “Safety net” (Community wide action)
Focus on priorities:
– volumes
Chemicals
Agency
to efficiently
manage
theregister
system
• High
(chemicals
with
greatest likely
exposure
first)
• Greatest concern (Carcinogenic, Mutagenic and Reprotoxic register first)
REACH - Registration
AIM: Ensure industry adequately manages risks from substances
 Manufacturers and importers obtain information on
their substances and
 use this knowledge to ensure responsible and wellinformed management of the risks these substances
may present throughout their life cycle
 Documentation: Electronic Registration dossier
submitted to Agency
 Certain non-confidential information to central (largely
public) database
No formal acceptance - industry retain responsibility
REACH - Registration
AIM: Ensure industry adequately manages risks from substances
Scope
– Substances  1 tonne/year per
manufacturer/importer (M/I)
– Exemptions: Some other law, Annex IV/V;
polymers (review); R&D (PPORD)
– Intermediates: Exempted or reduced requirements
– Considered as registered: biocides, pesticides,
notified/ELINCS substances (but only for the one
who has notified !)
• Consortia encouraged
No formal acceptance - industry retain responsibility
REACH – Evaluation
(by Agency and Member States)
Provide confidence that industry is meeting obligations
Prevent unnecessary testing
Dossier evaluation
Check test proposals
Compliance
Substance evaluation
Examine any information on a
substance
Output:
• Further information decisions
• Info to other parts of REACH/other legislation
REACH - Authorisation
•
•
•
•
Ensure risks from substances of very high concern are properly
controlled or that the substances are substituted.
Applies to
– CMR, PBT, vPvB, ‘equivalent concern’ *
– Substance, substance in preparation (unless below
concentration limit), substance incorporated into an
article.
Prioritised - Substances are progressively authorised (as
resources allow)
Substance cannot be used unless it is authorised
Authorisation applicant (industry) to show:
– adequate control of risks, or
– social and economic benefits outweigh the risks and no
suitable alternatives
•
Commission decision based on Agency opinion
* CMR: Carcinogenic, Mutagenic or toxic to Reproduction
* PBT: Persistent, Bio-accumulative and Toxic
* vPvB: very Persistent and very Bio-accumulative
REA(R)CH - Restrictions
Safety net
• Community wide concern
• Members States or Commission initiated
• Agency Committees examine:
– the risks, and
– the socio-economic aspects involved
• Commission - final decision
• Carry-over of existing restrictions
(76/769/EEC on marketing and use).
European Chemicals Agency
• Day to day management of REACH
– Technical, scientific and administrative aspects
• Responsibilities:
– Registration - reject or require completion of registration
– Evaluation – main tasks in conduct; priority setting;
coordination and harmonisation
– Authorisation/restrictions - facilitate process; suggest priorities.
– Secretariat for Forum and Committees
– Deal with appeals - registration, R&D, evaluation,
confidentiality
• Location: Helsinki, Finland
• Fully operational: Entry into force + 12 months (2008)
REACH main changes
• One regulation replaces a number of legal acts on
new/existing chemicals
• Burden of proof for safe use shifted from authorities
to industry
• No registration – no manufacture or import
• Registration for all substances manufactured or
imported > 1 tonnes/yr
• Chemical Safety Report for all substance
substances manufactured or imported > 10
tonnes/yr
REACH main changes
• Agency do not approve industry registration and
chemicals safety report
• Authorities evaluate selected dossiers for
compliance with REACH
• Authorities evaluate selected substances based on
a priority setting
• MS authorities are responsible for enforcement
REACH main changes
• Communication in supply chain play an important
role in preparing registrations
• More precise information to the user on how to use
substances/ preparations
• Increase awareness among downstream users
New roles for the actors
New roles for the actors
Main processes (actor underlined)
• Registration
• Downstream users
• Authorisation
Registration
•
How to demonstrate safe use of chemical
- Registration dossier
- Information requirements
- Chemical Safety Report
- Exposure Scenarios -> Extended Safety Data
Sheets
Registration
AIM:
Manufacturers and importers obtain information on
their substances and
use this knowledge to ensure responsible and wellinformed management of the risks these
substances may present throughout their life cycle
Registration Dossier = Documentation
 Technical Dossier: starting at 1 tonnes per year
Chemical Safety Report: starting at 10 tonnes/year
No formal acceptance - industry retain responsibility
Registration
Fully in
force
Start + 12 m
No of substances
Proposal
+ 3 yr
+ 11 yr
+ 6 yr
+ 18 m
Preregistrat
ion
Adoption
20.000
1 - 10 t
Consortia
formation
registration
Consortia formation
registration
Consortia formation
registration
Testing, Safety Assessment, Registration
phase-in substances
2.600
1000 t + CMR ...
2000
2003
2007
2008
2.900
100 - 1000 t
2010
2014
4.600
10 - 100 t
2019
What is a pre-registration ?
• Submission within 18 months of entry into force of a
simple pre-registration dossier to the Agency:
– Substance identity
– Name and address of registrant
– Expected dead-line for registration (tonnage
dependant)
– Other information (art 28(1)(d)
• Substances not pre-registered have to be
registered before marketing (similar to non-phase
in)
Registration:
Information requirements
• Data on physicochemical and toxic properties
• The higher the tonnage, the higher the standard
information requirements (REACH Annex VII-X)
• NB! All available data must be collected
regardless of tonnage (REACH Annex VI – step 1)
Animal testing and data sharing
• REACH aims to reduce the need for animal testing:
– Annex XI provides for adaptation of standard data
• Testing not technically possible
• Exposure-driven testing
• Alternative methods (QSAR/in vitro/grouping/readacross)
– Testing proposal when vertebrate testing is needed
– Substance Information Exchange Fora (SIEF) for
the same pre-registered substances
– ‘Mandatory’ sharing of vertebrate animal data
Testing only when necessary
Read Across
(Q)SARs
Waiving:
• technical
• exposure
In-vitro
Endpoint
Information:
Annexes VII-XI
Last resort
TESTING
Existing
information
Legal access to data on inherent
properties
• The registrant must have legal access to the study
reports for data used for a registration
• Cost sharing to be agreed in the Substance
Information Exchange For a (SIEF)
• NB! Mandatory sharing of vertebrate animal data
What is the Chemical Safety Report
(CSR) ?
• The CSR is the documentation of the Chemical
Safety Assessment covering:
– Hazard Assessment of the inherent properties;
physicochemical and toxic properties
– PBT and vPvB assessment*
• and when substance is dangerous or PBT/vPvB
– Exposure Assessment quantifying human and environmental
exposure levels
– Risk Characterisation
– Development of Exposure Scenarios
Registration dossier - content
Substance to be
registered
> 10 tonne/year
Subst. dangerous
or PBT/vPvB
Technical Dossier
•Identity of substance
•Manufacture and use
•Classification and labelling
•Guidance on safe use
•Study summaries
•Test proposals (if relevant)
•Exposure information
Also
Chemical Safety Report
•Hazard and PBT Assessment
Also
Chemical Safety Report
•Hazard and PBT Assessment
•Exposure Assessment
•Risk Characterisation AND
•Exposure Scenarios
What is an Exposure Scenario (ES) ?
– Conditions for use:
• Process description (incl. quantity used)
• Operational conditions (incl. frequency and
duration of specified operations)
• Risk Management Measures
–
–
–
–
process control (e.g. closed system, local exhaust)
emission control
personal protective equipment
good hygiene / working practise.
– Other relevant information
How will the user know?
Exposure Scenarios will be attached to the
Safety Data Sheet (SDS)
-> Extended Safety Data Sheets (e-SDS)
Annex:
ESs
ESs
ESs
Safety
Data
Sheet
REACH actors
• Registration
• Downstream users
• Authorisation
Downstream users
• Obligation to identify and apply measures to
control risks
• Include this in communication to customers
• Obligation to communicate up in supply chain
• Obligation to report to authorities
• Obligation to keep and update information
• Right to make use known to supplier
Who is a Downstream User
Distributor
Manufacturer/importer
Formulator 1
Downstream
users
Formulator 2
Industrial user
Professional user
1) use as process aid
2) Incorporation into articles
Consumer
The Downstream User
Must:
• Implement Operational Conditions and Risk
Management Measures communicated to him via the
exposure scenarios in the SDS Annex
• If he uses the chemical outside the conditions
described in the exposure scenario(s)
– Inform his supplier of this use to make it an identified use
– Alternatively:
• Conduct a safety assessment for his own use (and for
his downstream uses if he is a supplier)
• Implement ES from own safety assessment
• Report to the Agency
• Communicate further down the supply chain if he is
supplier
Simplified workflow: check of SDS/ES
Check SDS/ES
Use covered
and
Make use/ use conditions known
n
Find alternative supplier
Make DU CSA
conditions
Comply with
ES?
n
Implement suppliers ES
n
y
OK
y
Conditions in place meat at least
conditions in suppliers ES
Right to make use known to supplier
• Manufacturer and importer:
– may not know the use or conditions of use
– need sufficient information in order to continue
supply
• Downstream User (DU):
– need continued supply (own and customers use)
– need an ES to reflect the use conditions in the
market
Supply chain communication
Supplier
SDS including
Exposure Scenarios
(Recommended Risk
Management
Measures)
Safety
Data
Sheet
Downstream user(s)
Identify use
Supply chain communication
Supplier
SDS including
Exposure Scenarios
(Recommended Risk
Management
Measures)
Safety
Data
Sheet
Downstream user(s)
Identify use
Right to make use known to supplier
• What should DU communicate?
– Sufficient information for preparing ES
• How to organize communication?
– System developed for “brief description of use”
– Standard Exposure Scenarios
• Sector organizations have a key role in developing
standard Exposure Scenarios for their sector
REACH actors
• Registration
• Downstream users
• Authorisation
Authorisation
• Applies to
– CMR, PBT, vPvB, ‘equivalent concern’
– Substance, substance in preparation, substances in
articles.
• Prioritised - Substances are progressively authorised
(as resources allow)
• Substance cannot be used unless it is authorised
• Authorisation applicant (industry) to show:
– adequate control of risks, or
– social and economic benefits outweigh the risks and
no suitable alternatives
• Commission decision based on Agency opinion
Substances of very high concern
Criteria in REACH Annex XIII:
• PBT substances
• vPvB substances
• CMR cat 1,2 substances
But also:
• Substances of equivalent concern (Art. 56f) – see
next slide
‘Equivalent level of concern’
• PBT-like substances
– just not meeting one of the Annex XIII criteria, and other
information available
– (bio)monitoring data
– substances with PBT constituents
– metabolites with PBT properties
• CMR-like (serious and irreversible effect that
cannot be assessed with a standard risk
assessment)
• Substances with endocrine disruption properties
• Other equivalent concern substances
Overview of authorisation procedure (1)
Step 1 –
Inclusion of substances in the list of substances
subject to authorisation (Annex XIV)
Agreement /
COM decision
EU Member
State or
Agency
Agency
Comments
prepares
Candidate recommends
an Annex - Authorities
list
priority
XV dossier - interested parties
COM
decision
Annex
XIV
substances
First list
within two
years
Authorisation application
Who
– Manufacturer(s), importer(s) and/or downstream
user(s)
For what
– One or several substances
– One or several uses
– Applicant’s own uses, his downstream actors’
uses
When and where
– Needs to be submitted to the Agency by the
application date defined in Annex XIV
Authorisation procedure
Step 2-
Granting (or refusing) the authorisation
Applicant
applies for
authorisation
for a substance
on Annex XIV
Interested parties
- Information on
alternatives
Agency
C’ttees’
draft
opinions
COM review
authorisation
Applicant’s
comments
Applicant’s
review
report
Agency
C’ttees’
opinions
COM
decision
Authorisation
granted /
not granted
Thank you for your attention !
Articles
Registration of substances in articles
•
Any article producer or importer shall
register substances contained in articles if
– There is intended release under normal and
reasonably foreseeable conditions of use
– > 1 t/a in the articles per producer or importer
– if not already registered for use in articles
Notification of substance in articles
• Any article producer or importer shall notify
Substances of Very High Concern (SVHC) in
articles if
– they are present in those articles in amounts totalling >1
t/a per producer or importer, and
– present in those articles above a concentration of 0.1%
weight by weight, and
– If not exempted via Article 7(6))
• Unless producer or importer can exclude exposure
to humans or the environment during normal or
reasonably foreseeable conditions of use and
disposal of the article.
REACH Art. 7(6)
• Registration and/or notification are NOT
NEEDED if the substance has already been
registered for that use
Information on safe use
Any producer or importer of an article must:
– Provide the recipient of the article with sufficient
information to allow safe use of the article,
including, as a minimum, the name of the
substance, if the article contains SVHC in a
concentration above 0.1% (w/w)
– NB!
• There is no tonnage trigger for this
requirement, which consequently also
applies to < 1 tonne/year situations.
• No exemption via article 7(6)
Substances in Articles:
• Registration: Follows the normal registration dead-lines
• Notification: Starts after 3.5 years
Notification of SVHC in articles
Pre-registration
Agency start up
•1000+ tonnes
•CMRs 1+ tonne
• very aquatic toxic
(R50/53) 100+ tonnes
100-1000 tonnes
1-100 tonnes
Non-phase-in substances
[6 months]
EIF 12 months
April
18 months
2007 ?
3 years
6 years
11 years
REACH: C and L Inventory
• Inventory :
– Any company marketing a chemicals substance must
submit information on C&L of the substance (NB! No
tonnage trigger)
– Public web-site managed by the Agency
– deadline – 3 years
• Industry needs to co-operate to resolve differences
in C&L
• Authorities may suggest EU harmonisation:
– CMRs
– respiratory sensitisers
– Other effects (on a case by case basis)