REACh: The New Toxicology Frontier
REACh
Registration, Evaluation and Authorization of Chemicals
Ohio Valley SOT
Wednesday, August 26, 2009
1
Presenters
Jennifer Galvin, PhD, DABT, CIH
Manager, Industrial Hygiene & Toxicology
ConocoPhillips
Tracy Hammon, MS, DABT
Director, Product Safety
ConocoPhillips
2
Overview
•
•
•
•
•
•
•
•
•
What is REACh?
Why REACh?
Goals of REACh
Impacts of REACh
General Information
Information Requirements
Technical Dossier
Chemical Safety Report
Extended SDS
3
What is REACh?
• New EU Chemicals Regulation
• REACh : Registration, Evaluation,
Authorization and Restriction of Chemicals
• REACh replaces 40 existing EU Chemical
Regulations and Directives
4
Stages of REACh
• Pre-registration: by December 2008
• Registration: for substances ≥ 1 ton/yr
• Evaluation: for high volume substances
which are of highest concern
• Authorization: only for substances of
highest concern
• Restriction: the Safety net
The European Chemicals Agency (ECHA)
was established to manage the system
5
REACh Timeline
http://guidance.echa.europa.eu/docs/guidance_document/nutshell_guidance.pdf
6
Why REACh?
• Lack of knowledge about chemical
hazards on the EU market.
• Prior legislation was regarded as slow &
burdensome.
• Incomplete information on existing
chemicals vs. new chemicals.
• The burden of proof was on regulators.
7
Goals of REACh
• Enhance transparency and efficiency
• Close data gaps between existing & new
substances.
• Manage and control potential hazards and
risks to human health and the environment
from the manufacture, import and use of
chemicals within the EU
8
Impacts of REACh
• REACh is a global business issue that will
drive major changes in the way chemical
businesses are organized
• REACh has the potential to be a major
threat to supply chain continuity
• Clear and decisive leadership and
management is needed
9
Businesses need to understand how
valuable these substances are to them, and
plan to make effective business decisions
based on this knowledge.
Decisions made today will impact future
business practices
10
No data = No market
11
REACh is a substance-specific
regulation
PRODUCT
12
Product
A
D
G
B
C
E
F
This product
contains 8
substances
Therefore, this
product will
require 8
registrations
H
13
Multiple Expert Requirements
•
•
•
•
•
•
•
•
•
•
•
•
•
lawyers
lobbyists
communicators
IT-specialists
regulatory experts
physicians
Toxicologists
hygienists
researchers
process engineers
purchasers & logistics
marketing network
Export/Import coordinators
14
Impacts of REACh
• Burden of proof has shifted to industry
• Industry will have to prepare a
comprehensive document including:
– Hazards
– Risks
– Risk management
15
Classification & Labeling
• Under the new Global Harmonized System
– Each substance will be required to undergo
classification
• Under REACh, this classification will be
documented in the registration dossier
16
Identified Uses
• Use of the substance must be included in
the registration
• If substance is hazardous, exposures
need to be assessed
17
REACh Phases
Pre-Registration
SIEF Formation
Registration
Evaluation
Authorization
Restriction
18
Pre-Registration
• Phase-in Substances
• Pre-registration deadline December 2008
• Approx. 143,000 existing substances were
pre-registered
– ECHA received about fifteen times more preregistrations than expected
19
SIEF
• Substance Information Exchange Forum
• Purpose:
– Data sharing (compulsory)
– Agreement on Classification and Labeling
20
Registration
• Substances > 1 ton/year
• Develop Technical Dossier
– Reduced requirements for intermediates
• Chemical Safety Assessment
• Classification
21
Technical Dossier
• Required for registration
• Information requirements – dependent on
tonnage band
• Contents:
– Information on manufacture & use of substance
– Physical characteristics, toxicological &
ecotoxicological properties
– Proposals for testing if appropriate
– Indication of information submitted that should not be
made available on internet & why
22
Proposals for testing….if appropriate
This is not a regulation that
requires testing
1.
2.
3.
4.
Provide the data available
Do the risk assessment
Determine data gaps
Drive testing requirements
23
Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf
24
All Substances >1 ton/year
Physical
Tox/Ecotox Requirements
Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf
25
+
10 - 100 tons/year
Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf
26
+
100 - 1000 tons/year
Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf
27
+
> 1000 tons/year
Source: http://www.api.org/ehs/health/upload/API_REACH_Guide.pdf
28
Evaluation
• Substances > 10 tons/year
• Chemical Safety Assessment
• Requires detailed Chemical Safety Report
– Required if a substance is dangerous, PBT or a
vPvB
– Risk characterization on exposures from
intended uses
– Risk Characterization
29
Chemical Safety Assessment
• Safety (physico-chemical)
• Human health
• Evaluate data
• Classification and labelling
• Establish Derived No-Effect Level (DNEL)
• Environmental
• Evaluate data
• Classification and labelling
• Establish Predicted No-Effect Concentration
(PNEC)
30
DNELs and PNECs
• DNEL: Derived No Effect Level
• PNEC: Predicted No Effect Concentration
31
Exposure Scenarios
•
Manufacture and intended uses
–
•
•
•
substance life cycle (including disposal/recycling)
Include
•
processes and tasks
•
frequency and duration (how often and how long?)
•
operational conditions
•
representative exposure data or modelling data
•
What risk management measures are required?
For each human population exposed
–
Workers
–
Consumers
–
Indirect
Included as an appendix to the Safety Data Sheet (SDS)
–
Now called an Extended Safety Data Sheet (eSDS)
32
Risk Management Measures
• Must address workers, consumers, and the general public
• For workers, consider…
• Hierarchy of control
• Principles of Good Control Practice (COSHH)
• All routes of exposure (e.g., inhalation, dermal, ingestion)
• Determine residual risk
• Risk Characterization
– compare exposure with the relevant DNEL
33
Environmental Assessment
PBT
Persistent, Bioaccumulative & Toxic
vPvB
very Persistent & very Bioaccumulative
34
Extended Safety Data Sheet
(eSDS)
• Used to communicate hazard down the
supply chain
• Increased requirements compared to
current EU standard
• Exposure scenarios
35
Authorization
• Required for all substances of very high concern
• Approx. 1,500-2,000 substances
• Time limited
• Substances of very high concern are:
•
•
•
•
CMR (Carcinogen, Mutagen or Toxic for Reproduction Cat.1 or 2)
PBT (Persistent & Bioaccumulative & Toxic) or
vPvB (Very Persistent & Very Bioaccumulative & Toxic)
substances of equivalent level of concern
• Applicants must
• demonstrate adequate control of risks or that socio-economic
benefits outweigh risks
• develop substitution plans or inform on research to find
alternatives
• Restrictions can be applied to any substance
36
Conclusion
• Global Impact of REACh
– US – TSCA Reform
– China – ROHS
– Taiwan
– Canada
The Fall-Out
37
38