REACH,
an American expat’s experience
Sean Mahar
Euro Safety and Health
sean@eurosh.com
REACH
• REACH
Registration,
Evaluation and
Authorisation of
CHemicals
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
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
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
• 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
for Substances of very high concern (SVHC):
Carcinogenic, Mutagenic or toxic to Reproduction
(CMR) classified in category 1 or 2,
Persistent, Bioaccumulative and Toxic (PBT) or
very Persistent and very Bioaccumulative (vPvB)
included in Annex XIV of REACH. Once
included, they cannot be placed on the
market or used after date set “sunset date”
unless the company is granted an
authorisation.
REACH actions
Manufacturers/Importers
 Registration for all substances >1 tonne
 Chemical Safety Report (CSR) for all substances
>10 tonne
 Participation in Substance Information Exchange
Fora (SIEFs)
REACH actions
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
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
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).”
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.
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
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
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).
Chemical Safety Assessment
Exposure Assessment
• Generation of exposure scenario(s) or
the generation of relevant use and
exposure categories
• Exposure estimation
Chemical Safety Assessment
Exposure Estimation
– emission estimation
– assessment of chemical fate and
pathways
– estimation of exposure levels.
Chemical Safety Assessment
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
DNEL
Derived no effect level
“the level of exposure
above which
humans should not
be exposed”
DNEL factors
Exposure pattern:
•
population likely to be exposed,
•
frequency and duration of exposure,
•
route of exposure
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
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.
• in CSR
• in Extended Safety Data Sheet
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 contributing scenarios
industrial spray painting
• conditions for mixing and filling of equipment (manually)
• conditions for mixing and filling of equipment (automated)
• conditions of cleaning the equipment (manually)
• conditions of cleaning the equipment (automated)
• manual spraying with LEV and no respiratory/skin protection
• manual spraying without LEV, but respiratory/skin protection
applied
• robot-spraying (closed-automated)
• conditions during drying of coated article (closed-automated)
• conditions during drying of coated article (open-ventilated)
Occupational Exposure
Assessments
Three elements
1. emission estimation
2. assessment of chemical fate and
pathways;
3. estimation of exposure levels.
Occupational Exposure
Assessments
Exposure Modeling Tools
– ECETOC TRA
– Stoffenmanager
– EMKG/ BauA-COSHH
– ART “Advanced Tool” for inhalation exposure
assessment
– RISKOFDERM
– BEAT (Bayesian Exposure Assessment Tool)
– ECHA’s CSA-Tool Chesar
ECETOC TRA Tool
Stoffenmanager
www.stoffenmanager.nl
3 different versions:
•
control banding of chemical risks;
•
quantitative exposure assessment, and
•
REACH worker exposure assessment.
Stoffenmanager
EMKG/ BauA-COSHH Tool
http://www.reach-clphelpdesk.de/reach/en/Exposure/Exposure.html
•
part of the “Easy-to-use workplace control
scheme for hazardous substances” (EMKG
“Einfaches Maßnahmenkonzept für
Gefahrstoffe”) of the Federal Institute for
Occupational Safety and Health (BAuA).
EMKG/ BauA-COSHH Tool
Advanced Reach Tool (ART)
www.advancedreachtool.com
•
Incorporates a mechanistic model of
inhalation exposure and a statistical facility
to update the estimates with the user’s own
data.
•
“This combination of model estimates and
data produces more refined estimates of
exposure and reduced uncertainty.“
Advanced Reach Tool (ART)
RISKOFDERM
http://producttesting.eurofins.com/media/18263/toolkit_setup.zip
•
Eurofins was responsible for a Working
Group that developed a toolkit providing
employers with means of ranking dermal
exposure risks in workplaces and with
guidance on control measures for improved
protection
RISKOFDERM
Bayesian Exposure
Assessment Tool (BEAT)
http://xnet.hsl.gov.uk/download/
•
an advanced probabilistic model for
predicting dermal exposure. TNO is
developing BEAT together with the UK
Health &Safety Executive.
CHEmical Safety Assessment and
Reporting tool (CHESAR) Tool
http://chesar.echa.europa.eu/
•
developed by the European Chemicals
Agency (ECHA) to support industry in
preparing a Chemical Safety Assessment
(CSA) and Chemical Safety Report
(CSR)
CHEmical Safety Assessment and
Reporting tool (CHESAR) Tool
Tool Test
Cleaning with MEK
Full shift (300 min), daily
Wipe applied to large surfaces
No ventilation or PPE
Large room
Tool Test
ART
10,000 mg/m³
4 measurements (11, 4.1, 9.3, 2.6) 5.7 mg/m³ GM
ART Bayesian
Stoffenmanager
17,000 mg/m³
3,693 mg/m³
Risk Management Measures
(RMM)
Purpose
• To mitigate hazards identified for
occupational users, consumers and to the
environment
CLP
Regulation on Classification, Labelling
and Packaging of Substances and
Mixtures
• Implements GHS in Europe
• Applies to substances from 1 Dec 2010
• Applies to mixtures from 1 June 2015
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.
http://guidance.echa.europa.eu/guidance_en.htm