Transcript HL1115 Influences on Health at Work

REACH,
an introduction
Sean Mahar, PhD, CIH, CSP, PE
MIOSH, MFOH
Course Description
• The aim of this course is to enable the
student to understand the implementation of
Registration, Evaluation, Authorization and
Restriction of Chemicals regulation
(REACH). Information will be provided on
the status of the Substance Information
Exchange Fora. What comprises a
Chemical Safety Report will be described
along with requisite assessments.
Course Description
• The requirements for exposure assessment
under the REACH Regulation will be
discussed with information provided on how
to construct Exposure Scenarios. The
meaning of Risk Management Measures
(RMM) under the REACH Regulation will be
described along with how they must be
applied to adequately control risks to human
health and the environment.
Course Outline
• Introduction to REACH
• Substance Information Exchange Fora
• Chemical Safety Assessments
• The Chemical Safety Report
• Human Health Hazard Assessments
• Occupational Exposure Assessments
Course Outline
• Exposure Scenarios
• Risk Management Measures (RMM)
• RMM for occupational, consumers and
environment
• The RMM library
• Overall risk reduction strategy
Learning Outcomes
Upon completion, the participants will be able to:
• Gain a broad understanding of the REACH
Regulation and how it is implemented.
• Describe the requirements for exposure
assessment under the REACH Regulation, and
how to construct Exposure Scenarios.
• Identify the requirements for exposure assessment
under REACH
Learning Outcomes
• Describe how exposure assessments fit into the
risk characterization and management process
• Compile ESs for typical activities
• List how DNELs and DMELs are derived
• Apply RMM in occupational exposure situations,
and be aware of RMM applied to consumers and
environmental emissions.
• Define how RMM fit in an overall risk management
strategy
Sean Mahar
• BS, Sacred Heart University
• MS, Texas A&M University
• PhD, University of Iowa
• Certified Industrial Hygienist
• Certified Safety Professional
• Professional Engineer
Experience
• Euro Safety and Health, 5 years
• U of Wolverhampton, 7 years
• Ohio University, 3 years
• Worksafe Iowa, 3 years
• US Navy, 9 years
• Tracor, 1 year
Introduction to REACH
REACH
• REACH
Registration,
Evaluation and
Authorisation of
CHemicals
REACH
• In October 2003, the European
Commission adopted a proposal for a
new EU regulatory framework for
chemicals – REACH
• The REACH regulation entered into
force June 1, 2007.
REACH deadlines
• 1 June 2007: REACH entry into force
• 1 Dec. 2008: pre-registration ends
• 1 Dec. 2010: registration > 1,000 t/y, or
CMR 1 or 2 > 1 t/y, or
R50-53 (PBT/vPvB) > 100 t/y
• 1 June 2013: registration > 100 t/y
• 1 June 2018: registration > 1 t/y year
REACH Objectives
• Protection of human health and the
environment
• Maintenance and enhancement of the
competitiveness of the EU chemical
industry
• Prevention of fragmentation of the
internal market
REACH Objectives
•
•
•
•
Increased transparency
Integration with international efforts
Promotion of non-animal testing
Conformity with EU international
obligations under the WTO
Registration
• Registration of basic information
– all existing and new substances exceeding
a production volume of 1 tonne
– submitted by companies and entered in a
central database
Evaluation
• Evaluation of the registered information
for all substances exceeding a
production volume of 100 tonnes
– includes development of substance tailored
testing programs
– focus on the effects of long-term exposure
Authorisation
• Authorisation of substances which are
carcinogenic, mutagenic or toxic to
reproduction (CMRs), persistent, bioaccumulative and toxic (PBTs), very
persistent, very bio-accumulative (vPvBs)
and Endocrine disrupting substances on
a case by case basis
Restriction
 Restriction in the use of chemicals to
manage risks that have not been
adequately addressed by another part
of the REACH system
REACH Implications
Manufacturers/Importers
 Registration for all substances >1 tonne
 Chemical Safety Report (CSR) for all substances
>10 tonne
 In the absence of available information, tests may
have to be conducted
 Data sharing (in particular for vertebrate tests)
 Substance Information Exchange Fora (SIEFs)
REACH Implications
Downstream Users (Customers)
 Apply the risk management measures identified
in the SDS Exposure Scenario
 Make their uses known to
manufacturers/importers
 or carry out their own CSA
 (confidentiality reasons)
 Contribute to SIEFs
REACH Guidance
REACH Implementation Projects (RIPs)
RIP 1: Process descriptions
RIP 2: Development of IT systems (IUCLID
database and REACH-IT)
RIP 3: Guidance Documents for industry
RIP 4: Guidance Documents for authorities
RIP 5/6: Setting up the Agency
Substance Information
Exchange Forum (SIEF)
Mandatory forum created during preregistration to assist the sharing and data
collection of REACH compliance information
and studies with other registrants of the
same substance.
SIEF Members
• Potential Registrants
• Third Party Representatives
• Data Holders
• Others
SIEF Roles
• SIEF Formation Facilitator
• Lead Registrant
• Legal Entity User
• Invited Expert
• Data Holder
CEFIC SIEF Codes
European Chemical
Industry Council
Brussels-based
organization
representing the
European chemical
industry.
•
Leading
•
Involved
•
Passive
•
Dormant
CEFIC SIEF Codes
•
•
Leading “This is a substance of high
strategic importance for my company and I
have available resource to (co) lead and
drive registration to completion.”
Involved “My company is registering and
may be actively involved. My company will
receive a SIEF progress report, an invoice
and an invitation to comment.”
CEFIC SIEF Codes
•
•
Passive “My company has the intention to
register this substance. My company will
receive a SIEF progress report and an
invoice.”
Dormant “My company has no intention to
register nor to spend money. My company
will receive no communications and no
invoice (besides mandatory data sharing).”
Chemical Safety Assessments
The goal of the CSA is to identify and describe
the conditions under which the risks are
controlled.
Risks are regarded as controlled when the
estimated exposure levels do not exceed
the derived/predicted no effect levels (DNEL
or PNEC).
DNEL
Derived no effect level
“the level of exposure
above which
humans should not
be exposed”
DNEL factors
Uncertainty arising 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
Derivation of DNELs
1. Derivation of typical dose descriptor(s)
(NOAEL, NOAEC, etc.)
2. Modification of the dose descriptor(s) to
the correct starting point
3. Application of Assessment factors to the
correct starting point to obtain the
DNEL(s)
4. Selection of the leading DNEL/Health
Effect
PNEC
Predicted no effect concentration
“the concentration of the substance below
which adverse effects in the
environmental sphere of concern are
not expected to occur”
PNEC
Spheres
•
aquatic (including sediment)
•
terrestrial
•
atmospheric
•
food-chain accumulation
•
microbiological activity of sewage
treatment systems
PNEC
Calculated by applying an appropriate
assessment factor to the effect values
(e.g. LC50 or NOEC).
The assessment factor expresses the
difference between effects values
derived for a limited number of species
from laboratory tests and the PNEC for
each environmental sphere.
Chemical Safety Assessments
Where no-effect levels cannot be determined,
the risk characterization is based on other
methods:
• Semi-quantitative or
• qualitative
assessment of the likelihood that adverse
effects are avoided.
Chemical Safety Assessments
For PBT and vPvB substances:
• risks are controlled when the emissions and
exposures are minimized by the
implementation of the exposure scenario.
Chemical Safety Assessment
(CSA)
1. Human Health Hazard Assessment
2. Human Health Hazard Assessment of
Physicochemical Properties
3. Environmental Hazard Assessment
4. PBT and vPvB Assessment
5. Exposure Assessment
6. Risk Characterization
Chemical Safety Assessment
(CSA)
Physicochemical Hazard Assessment
• Explosivity
• Flammability
• Oxidising potential
Chemical Safety Assessment
(CSA)
Environmental Hazard Assessment
• Evaluation of information
• Classification and Labeling
• Derivation of the PNEC
Chemical Safety Assessment
(CSA)
PVB and vPvB Assessment
• Comparison with the Criteria
• Emission Characterization
Chemical Safety Assessment
(CSA)
Exposure Assessment
• Generation of exposure scenario(s) or
the generation of relevant use and
exposure categories
Chemical Safety Assessment
(CSA)
Exposure Estimation
– emission estimation
– assessment of chemical fate and
pathways
– estimation of exposure levels.
Chemical Safety Assessment
(CSA)
Risk Characterization
•
human exposure comparison with DNEL
•
environmental exposure comparison
with PNEC
•
assessment of the likelihood and
severity of an event from
physicochemical properties
Risk Characterisation Ratio
(RCR)
PEC
Exposure
RCR 
or
PNEC
DNEL
PEC – predicted environmental concentration
Risk Characterisation Ratio
(RCR)
For non-threshold effects (e.g. non-threshold
mutagens and non-threshold carcinogens):
•
Derived minimal effect level (DMEL) a
reference risk level considered to be of
very low concern could be used
End result is a Semi-quantitative Risk
Characterisation
Exposure Scenarios (ES)
• a set of information describing the
conditions under which the risks
associated with the identified use(s) of a
substance can be controlled.
Exposure Scenarios (ES)
Two facets
• Operational conditions
• Risk management measures (RMM)
Exposure Scenarios (ES)
Operational conditions
• processes involved
• activities of workers and consumers and
environment
• duration and frequency of exposure
Exposure Scenarios (ES)
Risk management measures (RMM)
• to reduce or avoid direct and indirect
exposure of humans and the
environment during use and disposal
ES Structure
• Short title to flag the content
• Processes and activities covered
• Duration and frequency of use (as
relevant for workers, consumers and the
environment)
ES Structure
• Physical form of the product containing
the substance and concentration of the
substance
• Amounts used over a given period and/or
activity (as relevant for workers,
consumers and the environment)
• Other operational conditions of use
ES Structure
• Risk management measures for uses at
industrial sites (workers & environment)
• Risk management measures for uses
outside industrial sites (workers &
environment)
• Risk management related to uses by
consumers and the general public
(consumer & environment)
ES Structure
• Waste management measures related to
the uses covered in the exposure
scenario
• Predicted exposure and source of
prediction
• Advice to downstream users on how to
check whether or not they work within the
boundaries defined in the exposure
scenario
ES Process
1. Map uses of substance (in-house
information)
2. Compile available information on
conditions of use
3. Select appropriate process and product
categories
4. Build initial ES and run first exposure
estimation
ES Process
5. Complete initial ES (short title, covered
activity, OCs, RMM)
6. Invite and receive feedback from
representative DUs
7. Identify additional information (if
needed)
8. Carry out further CSA runs (iterations)
with the selected tool
ES Process
9. Decide whether measured data or
higher tier model needed
10. Apply other models or measured data
if needed, run CSA
11. Conclude exposure estimation and
risk characterization
ES Process
12.Derive integrated ES by linking all OCs
and RMMs
13.Merge different ES into a broader ES if
appropriate
14. Document
The Chemical Safety Report
The main goal of the chemical safety report
(CSR) is to document the chemical safety
assessment (CSA), including its conclusions
and results.
 Required for all substances >10 tonne
CSR Format
PART A
1. Summary of Risk Management Measures
2. Declaration That Risk Management
Measures Are Implemented
3. Declaration That Risk Management
Measures Are Communicated
CSR Format
PART B
1. Identity of Substance & Physical &
Chemical Properties
2. Manufacture And Uses
3. Classification And Labelling
4. Environmental Fate Properties
5. Human Health Hazard (HHH) Assessment
CSR Format
PART B
6. HHH Assessment of Physicochemical
7. Environmental Hazard Assessment
8. PBT And VPVB Assessment
9. Exposure Assessment
10. Risk Characterization
Human Health Hazard
Assessment
Objective
• to determine the classification and labelling
of a substance in accordance with Directive
67/548/EEC; and
• to derive levels of exposure to the
substance above which humans should not
be exposed (DNEL).
Human Health Hazard
Assessment
Steps
1. Evaluation of non-human information
2. Evaluation of human information
3. Classification and Labelling
4. Derivation of DNELs
Occupational Exposure
Assessments
Three elements
1. emission estimation
2. assessment of chemical fate and
pathways;
3. estimation of exposure levels.
Occupational Exposure
Assessments
Hierarchy for estimation of exposure levels:
1. measured data, including the quantification
of key exposure determinants
2. appropriate analogous/surrogate data,
including the quantification of key exposure
determinants
3. modeled estimates
Occupational Exposure
Assessments
European Centre for Ecotoxicology and
Toxicology of Chemicals Targeted Risk
Assessment (ECETOC TRA) Tool
Stoffenmanager
Easy-to-use workplace control scheme for
hazardous substances (EMKG/ BauACOSHH)
ECETOC TRA Tool
Available at www.ecetoc.org
• Screening tool: intentionally conservative
assumptions to prevent false negatives
• Risk-based, tiered approach
• Evaluates uses and identifies handling
procedures associated with safe use
• Covers worker, consumer and
environmental exposures
ECETOC TRA Tool
Based on Estimation and Assessment of
Substance Exposure (EASE) model
•
Established UK Health and Safety
Executive occupational exposure model
•
Categorizes exposure based upon historical
data in National Exposures Database
•
Exposure predicted based upon conditions
of use and physical- chemical properties
ECETOC TRA Tool
www.stoffenmanager.nl
EMKG/ BauA-COSHH Tool
www.reach-helpdesk.de
Risk Management Measures
(RMM)
Purpose
• To mitigate hazards identified for
occupational users, consumers and to the
environment
The RMM library
an EXCEL spreadsheet with three parts:
1. The library containing RMMs / OCs and
details of their effectiveness; and
2. Lists of information sources for consumers,
environment and occupational measures.
3. A practical guide to use the library
cefic.org/en/reach-for-industries-libraries.html
RMM – Basic Principles
Hierarchy of control (Chemical Agents
Directive 98/24/EC)
• Article 6 Specific protection and
prevention measures, requires that risk
be eliminated or reduced to a minimum
by substitution
• If not substitution isn’t possible then by
protection and prevention
Hierarchy of control
(a) design of appropriate work processes and
engineering controls
(b) application of collective protection
measures at the source, such as adequate
ventilation and appropriate organizational
measures;
(c) application of individual protection
measures including personal protective
equipment.
RMM – Basic Principles
Principles of Good Control Practice from the
Control of Substances Hazardous to Health
Regulations (COSHH) Schedule 2A
COSHH Good Practice Principles
(a) Design and operate processes and
activities to minimise emission, release
and spread of substances hazardous to
health.
(b) Take into account all relevant routes of
exposure- inhalation, skin absorption and
ingestion- when developing control
measures.
(c) Control exposure by measures that are
proportionate to the health risk
COSHH Good Practice Principles
(d) Choose the most effective and reliable
control options which minimise the escape
and spread of substances hazardous to
health.
(e) Where adequate control of exposure
cannot be achieved by other means,
provide, in combination with other control
measures, suitable personal protective
equipment.
COSHH Good Practice Principles
(f) Check and review regularly all elements of
control measures for their continuing
effectiveness.
(g) Inform and train all employees on the
hazards and risks from the substances
with which they work and the use of control
measures developed to minimise the risks.
(h) Ensure that the introduction of control
measures does not increase the overall
risk to health and safety.
COSHH Essentials
The Health and Safety Executive
developed COSHH Essentials as a
tool for Small to Medium Enterprises
(SMEs) to use for risk assessments:
www.coshh-essentials.org.uk
It is useful for many operations and can
serve as a screening tool, but is not a
substitute for a risk assessment.
COSHH Essentials
A “DIY” approach for SME’s in Five Steps:
1. Getting Started
2. Factors to decide control approach
3. Find the correct control approach
4. Find task-specific control guidance sheets
5. Implement action and review
COSHH Essentials
1.
•
•
•
Getting Started
What is in use?
How is it used?
Where is it used?
COSHH Essentials
2.
•
•
•
Factors to decide control approach
Possible health effects
Amount in use
Dustiness or volatility
COSHH Essentials
3. Find the correct control approach
• Matrix of
Hazard group
Amount
Volatility or Dustiness
Amount
Hazard group C:
Dustiness or volatility
Low
Medium
High
Small
1
2
2
Medium
2
3
3
Large
2
4
4
COSHH Essentials
4. Find task-specific control guidance sheets
COSHH Essentials
5. Implement action and review
The RMM library
Extended Safety Data Sheet
(SDS)
Where ESs developed as a result of
conducting a CSA, they must be annexed
to the SDS and passed down the supply
chain.
Supplier informs his customer about the RMM
recommended for safe uses of the
substance.
Registration Dossier
Contents:
• a technical dossier, for substances in
quantities of 1 tonne or more per year,
and, in addition,
• a chemical safety report, for substances
in quantities of 10 tonnes or more per year.
Technical Dossier
Contains information on the properties and
classification of a substance as well as on
uses and guidance on safe use.
The information required varies with the
tonnage in which the substance is
manufactured or imported.
The higher the tonnage the more information
on the intrinsic properties of the chemical
is required.
Chemical Safety Report
Documents the hazards and classification of
the substance and the assessment as to
whether the substance is PBT or vPvB.
If the substance is classified as dangerous or
is PBT or vPvB, then an exposure
assessment and risk characterisation shall
be performed to demonstrate that the risks
are adequately controlled. This exposure
assessment is done using ESs for each
use.
Topics
• REACH
• ES
• SIEF
• RMM
• CSA
• RMM for occ.,
consumers and env.
• CSR
• HHH Assessments • RMM library
• Overall risk
• Occ. Exp.
reduction strategy
Assessments
Outcomes
Can we?
• Understand the REACH Regulation and
how it is implemented.
• Describe the requirements for exposure
assessment under the REACH Regulation,
and how to construct Exposure Scenarios.
• Identify the requirements for exposure
assessment under REACH
Outcomes
• Describe how exposure assessments fit into the
risk characterization and management process
• Compile ESs for typical activities
• List how DNELs and DMELs are derived
• Apply RMM in occupational exposure situations,
and be aware of RMM applied to consumers and
environmental emissions.
• Define how RMM fit in an overall risk management
strategy
http://guidance.echa.europa.eu/guidance_en.htm
http://guidance.echa.europa.eu/docs/
guidance_document/information_requirements_en.htm
Questions?