REACH: Driver of Innovation
Andrew Fasey
andrew.fasey@ptkltd.com
15 November 2005
Univ of Virginia, USA
Why I am here
• PTK Ltd: consultancy on regulatory chemicals
issues (e.g. REACH, GHS, SAICM)
• DG ENTR (until September 2004)
• author (1 of) of REACH
• co-decision process (Council & EP)
• implementation of GHS in EU
• UK government (HSE): international
chemicals policy
• policy on chemicals strategy White Paper
• author (1 of) of GHS: IOMC drafting group
• Acting head of UK delegation to IFCS III
• DG ENV chemicals unit (94 – 97)
• NONS, ESR, C&L
Presentation
• Introduction to REACH
– Why?
– Summary
• Innovation: Regulatory Drivers
• Innovation: Structural Drivers
• Progress in the Co-decision Process
• Opportunities
• Headline Messages
• Conclusions
Introduction to REACH:
Registration,
Evaluation, and
Authorisation of
CHemicals
WHY do we need REACH?
Problems
Current chemicals management system is inefficient
• Difficult to identify risks – difficult to address
risks:
– Lack of information about most substances on the
market
– Burden of proof on public authorities
– No efficient instrument to deal with problematic
substances
• Lack of incentives for innovation
• Lack of confidence in chemicals
Burden of the Past
Lack of Information
• Lack of hazard data for most substances on the
market:
No ‘Official’
Data
(20% of
number)
Limited Data
(45%)
Base Set
(20%)
Level
1
(10%)
Level
2
(5%)
• Unknown volumes & uses of most substances on the
market
• Incorrect C&L & SDS:
only 20% of substances & preparations in full compliance;
20% of errors for preparations ‘severe’.
Solution: A New EU
Chemicals Policy
Objectives
• 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
Substitution and precaution underpin system
R
E
A
C
H
What is REACH?
High level of health and environmental protection with the
goal of achieving sustainable development.
• Single coherent system for new (non phase-in)
and existing (phase–in) chemicals
• Elements:
– Registration of substances ≥ 1 tonne/yr (staggered deadlines)
– More information and better communication through the
supply chain
– Evaluation of some substances by Member States
– Authorisation only for substances of very high concern
– Restrictions - the safety net
– Agency to manage system
A Tiered Approach
• Focus on priorities:
– high volumes (early deadline)
– greatest concern (CMRs early)
Registration: general
Registrant collects information, assesses risk(s) and
implement/recommend relevant control measures
• Scope
– substances produced/imported ≥ 1 tonne/year
– Isolated intermediates: reduced requirements.
– Exemptions e.g. PPORD, polymers, non-isolated intermediates
• Tasks of the registrant (manufacturer/importer/only
representative):
– obtain adequate information (inc (Q)SAR and existing data)
– perform CSR for substances > 10 tonnes/year (demonstrate
adequate control per use)
– send information to Agency by deadline (and to clients)
• Consortia encouraged (Pre-registration)
No formal acceptance - industry retain
responsibility
Registration: Timing
Registration period for
existing substances
(per manufacturer or importer)
(Deadlines in Bold)
(assuming 2007 start)
≥ 1,000 tonnes p.a. or CMR
2007 - 2010
100 – 1,000 tonnes p.a.
2007 - 2013
High data
CSRs
10 – 100 tonne p.a.
2007 - 2018
1 tonne p.a.
2007 - 2018
‘Screening’
Intelligent Testing Strategies
Volume of substance
produced or marketed
Registration: Substances in
articles
Substance:
• dangerous and
• ≥ 1 tonne per m/i per yr (per article type)?
Intended release
Registration
Unintentional release
(quantity hazardous to HH or Env)
Release:
•known by producer/importer?
• made known to producer/importer?
Notification
Agency may require Registration
Deadline:
2018?
Information through the
supply chain
Improve risk management
• What:
– Expanded (M)SDSs with information from Chemical
Safety Reports (CSR) - exposure scenarios
– Information on risk management, authorisations,
restrictions, registration number etc.
– Information up the supply chain on new hazards
• Result?
– more information on risks
– downstream users benefit
– dialogue up/down the supply chainencouraged/stimulated
Downstream Users (DU)
• Manufacturer/importer CSR to cover all uses
identified by downstream users.
• DU benefit from choice of:
– supplier carrying out assessment, or
– for confidentiality reasons doing own assessment.
• If using suppliers CSR just have to:
– implement supplier’s RRM for identified uses
• If carrying own CSR will have to:
– perform assessments only for ‘unidentified uses’ (using
supplier hazard information)
– inform Agency of ‘unidentified uses’
Key Elements
• Better information
• Joined up supply chain
• Industry responsibility for safe
management
Innovatory Drivers
Regulatory Drivers
• Ending discrimination of new substances
versus existing substances => encourages
the development of new substances.
• Wide exemption for ‘product- and processoriented R&D’ (PPORD). Far wider than the
existing exemption from notification for new
substances => encourages R&D, potential to
avoid registration (substances and/or uses).
• PPORD exemption is up to 5 +5 years (15
years for medicinal products), far greater than
currently for new substances.
Regulatory Drivers
• Threshold for registration (1 tonne/year)
is much higher than the current 10 kg
threshold for notification of new
substances.
• The costs of registering a new
substance significantly lower than
currently as less data is required.
• Registration will be quicker than the
current notification, thus reducing the
time to market.
Regulatory Drivers
• Authorisation of SVHC (substances of very
high concern) for particular uses.
• Granted if use adequately controlled or, if not,
socio-economic assessment shows benefits
outweigh costs, taking alternatives into
account.
• Conditions and review periods may apply.
• Authorisation (cost, time, uncertainty) will
encourage companies to search for safer
substitutes and/or processes => companies
developing safer substances or processes
should be able to gain market share and/or
new markets.
Structural Drivers
• Concentration on SVHC:
– CMRs and other SVHCs prioritised for
Registration
– Authorisation of uses of SVHC
• Industry will have to demonstrate
‘adequate control’ => encourages
innovation of safer substances and
processes ad ‘safe’ uses
Structural Drivers
• Registration: complete data set
(tonnage related), risk assessment of
uses (own and downstream users) will
identify ‘risky’ substances and uses =>
incentive to innovate to safer
substances &/or uses.
• Better data may lead to reclassification
of substances/mixtures => need to
reformulate safer products.
Structural Drivers
• Evaluation: selection using ‘risk’
criteria => industry innovates to reduce
chance of evaluation.
Structural Drivers
• Substance withdrawal: estimates of 5 %.
Opportunities for alternative substances
and processes
• Information in the supply chain: better
information on properties, uses, and
needs of customers in the SC will
encourage innovation
Opportunities
Opportunities
Internal
• Better understanding of REACH and its
implications than competitors
• Holistic organisation to bring company
benefits
– Efficiency gains
– Joined-up working
• Flexibility in REACH, for example
– Data requirements
– PPORD
– Generic vs specific CSAs
• Be the solution not the problem
Opportunities (cont.)
Existing (and new) Business
• Better supply chain communication
– Trust
– Understanding
– Systems in place
• Good quality information
– SDS
– Exposure scenarios
• Demonstrate REACH compliance to customers (REACH
‘mark’)
• Competence on, confidence in, and support to, REACH
• Help suppliers and customers meet REACH requirements
– Generic / Customised CSAs
– Registration
– Data collection, generation and assessment
• Customers affected by other suppliers
– The solution not the problem
Opportunities (cont.)
New Business
• Better understanding of supply chain
• Alternatives - provide alternative substance,
process or supply
• Innovation – safer substances &/or
processes &/or uses
• Marketing - demonstrate CSR, Product
Stewardship etc
• Service - competence and understanding, ‘on
top of’ REACH, targeted CSA, support
offered
Progress in the Codecision Process
Timing
Nov 2003: Commission Proposal
submitted to Parliament and Council
Decision making in EP and
Council: 2004-2006
 Political agreement between MS: end 2005?
 Parliament 1st reading: November 2005?
REACH in force: end 2006/2007?
Co-decision Procedure
• COMP and ENV Councils
• EP Committees - ENVI lead, ITRE and IMCO
• Other EP Committees interested including
– ECON, EMPL, BUDG, FEMM, INTA
• Complete First Reading in EP – November 2005
• Revised Commission proposal – end 2005
• Council Common Position – UK Pres (end 2005)
– reaction to 1st Reading => becomes working text
•
•
•
•
•
Second Reading in EP (of Common Position)
Council Decision (based on 2nd Reading)
Conciliation Procedure? (EP, Council & CION)
REACH adopted - end 2006 (FIN Presidency)?
REACH in force 2007?
Headline Messages
1. Decisions are being taken now
•
•
•
Some companies have already made, or are
in the process of making, assessments of
their portfolio of chemicals.
They are making decisions on the chemicals
they will register and those that will be
withdrawn from the market, uses of
chemicals they will support through the
Registration process, and the timing of
Registrations (the first Registrations may be
expected in early 2007).
All these decisions can impact on your
business.
2. Waiting for a final text will be too
late for many to satisfy their duties
•
•
•
•
•
•
Final REACH text is not likely to be agreed before the end
of 2006 or early 2007
Waiting until then to prepare for REACH would be taking
an enormous risk.
Decisions are already being taken possibly in your
supply chains.
Need to be prepared so that you can either influence
these decisions or be in a position to react to them.
Lack of preparation could mean that decisions taken
would be based on incomplete knowledge or analysis.
To give an idea of the scale of the problem one major
consumer product company has 6,000 substances to
consider in their portfolio.
•
•
3. Need to understand the
implications of REACH for your
business
REACH will have implications for business
costs, personnel resources, R&D,
portfolios of chemicals, relations up and
down the supply chain, management
systems etc.
It is important to have a clear and realistic
understanding of the implications of
REACH so that decisions can be made on
objective information, not on rumour and
hearsay.
•
•
•
4. Develop supply chain
relationships
The key to implementing REACH efficiently and
effectively is to understand and influence each
supply chain.
Supplies and customers may be at risk;
understand which substances and customers
are at risk
Decide what steps you are going to take to
support and work with others in each supply
chain. For example
–
–
a supplier may withdraw a substance from the market
because of the cost of Registration unless you support
(financially or scientifically) the preparation of a
Registration; or
they may not support your use if the costs involved are
disproportionate to the benefits.
5. Important to keep ‘on message’
•
You will receive enquiries from
customers and suppliers addressing
REACH issues. It is important to
develop an approach to such
enquiries to ensure that customer
confidence is maintained or improved.
•
•
•
6. Registration (manufactured or
imported substances) will incur
significant costs
All substances that you export to the EU
(on their own, in mixtures, or in articles
(conditions apply)) in quantities of over 1
tonne per year will need to be registered
(some exemptions apply).
Resources needed to develop the data set
needed and to prepare risk assessments
(known as Chemical Safety Assessments
in REACH) for all supported uses (this
includes manufacture).
Importers or sole rep? Support?
7. Identify and assess alternatives
•
•
•
•
REACH will result in some substances being
withdrawn from the market by some suppliers.
You need to, based on your assessment of the
supply chain, identify where this may happen.
Identify or develop alternative processes that
could result in the same or equivalent products,
alternative substances that could deliver the
same or acceptable performance and efficacy, or
alternative suppliers of the same substance that
could guarantee supply.
Identify alternatives to substances that may
cause a problem in REACH e.g. subject to
authorisation, ‘adequate control’ is hard to
demonstrate.
Conclusions
• After 7 years… REACH will happen
• Real (& often final) political debate and decisions
happening now
• Prepare now for REACH
• Wait = too late
• Technical/scientific, legal, and business factors to
consider
• Opportunities presented
• Innovation encouraged
• In force early 2007
• Don’t forget the GHS
Contact
Andrew Fasey
andrew.fasey@ptkltd.com
www.ptkltd.com