Post on 14-Dec-2015
Overview & Implications for Affinia
Registration, Evaluation, and Authorisation of Chemicals
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 2
REACH in a nutshell • The most ambitious chemicals policy change in history
(40 Directives 1 Regulation)
• Basic principle of REACH: ensure substances that are manufactured, placed on the market or used without adversely affect human health or the environment….
• REACH will have enduring impacts globally
• Cost to Industry- EU estimates Eur 2.8bn to 5.2bn overt 11 yrs. Testing cost alone are estimated at Eur 2.6bn.
• Non-Compliance with REACH legislation means: • Business Risk• Potential law suits• Heavy fines• Removal from preferred vendor lists• Loss of company image
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 3
REACH: Changes to Responsibilities
Pre-REACH
• Responsibility is with the authorities to assess safe use of chemicals
• Generic information on the substance is provided by the producers
• Appropriate controls are identified and implemented by the users
• Little information on use is required to be supplied by downstream users
Post-REACH
• Responsibility is with industry to generate and evaluate substance data
• Industry is required to assess exposure associated with each identified use against the substance data
• Appropriate risk management measures need to be agreed between suppliers and downstream users
• Downstream users are required to identify use of each substance and ensure it is communicated up the supply chain
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 4
REACH – What is It?
• A regulatory system for management of chemicals (substances) in the EU
• Establishes information (testing) requirements for registration of new and existing chemicals
• Registration requirement applies to new and existing chemicals manufactured, imported, or used in the EU in volumes greater than 1 tpa
• Substances must be registered for their uses
• Authorises uses of Substances of Very High Concern (SVHCs = CMRs, PBT/vPvB, and endocrine disruptors)
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 5
REACH – Why is It?
• Aims to achieve a high level of protection of human health and the environment, while reducing the need for animal testing
• Brings a complicated patchwork of existing laws under one regulatory system for management of chemicals in the EU
• Former system was slow, inefficient, and was seen as a competitive disadvantage to the EU chemicals industry
• Overcomes the lack of data on existing chemicals (“Burden of the Past”) – applies to thousands of chemicals in broad commercial use for which limited environmental and toxicity data are currently available
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 6
REACH – Consequences
• Some substances (or their uses) may be restricted or banned
• Increases communication along the Supply Chain
• Shifts the burden of proof for chemical safety and risk from government to industry
• Targets the risk assessments to specific uses
• Considers the entire life cycle of substances (“cradle to grave”)
• Promotes substitution of “dangerous” chemicals with less hazardous alternatives
• Threat to business continuity – companies that do not comply will have no market
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 7
The Main Elements of REACH
• Registration – documentation and testing conducted by industry, requirements vary depending on volume and hazard classification
• Evaluation – agency review of registration dossiers (minimum of 5% of Technical Dossiers) and all proposals for additional animal testing; may lead to requests for further information or proposals for “restrictions” or no further action
• Authorisation – for specific uses of SVHCs industry must apply for their use and demonstrate adequate control of risk, or benefits outweigh the risk and there are no viable substitutes
• Restriction – designed as a safety net to the above, authorities provide strict limits on marketing and use or bans when industry measures to control risks are not sufficient
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 8
REACH - An OverviewRegistration
Technical dossier Chemical Safety
Report (>10 t/yr)
EvaluationDossier Evaluation, e.g., Animal testing
Substance Evaluation, e.g., Risk assessment
Authorisation
Supplier & user specific uses of substance only
Restriction
Ban certain substances completely
or for certain uses
When it has very hazardous properties
When it poses unacceptable risks
ECHA requests more information
No additional control if it does not require an
authorisation/ restriction
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 9
The REACH Process
* Carcinogenic, mutagenic or reprotoxic
** PBT = Persistent, bio-accumulative and toxic – vPvB = very persistent and very bio-accumulative
• use-related
• for CMR*, PBT and vPvB** substances
• for endocrine disruptors
• limited in time
> 2,000
Evaluation
• dossier evaluation
• substance evaluation
• further tests
> 5,00030,000
substances + intermediates
• before production or import
• product quantity
• use
• Chemical Safety Report for volumes of > 10 tons/ year
Registration Authorization
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 10
REACH – Who Does it Affect?
• Everyone – companies importing into, manufacturing, or using individual substances, preparations, and articles in the EU
• Manufacturers and importers must register their chemicals in order to sell them
• Downstream Users (DU) must ensure that the chemicals they are using have been registered for their applications
• Article manufacturers or importers may be required to register or notify substances in articles
• Note – only businesses established as “legal entities” in the EU are able to register
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 11
REACH Exemptions
• Exempt from REACH• Radioactive substances
• Substances under customs supervision
• Substances used in defense
• Waste
• Non-isolated intermediates
• Transported substances
• Exempt from Registration• Food or feedingstuffs
• Medicinal products
• Substances in Annexes IV and V of the regulation
• Recycled or recovered substances already registered
• Re-imported substances
• Polymers (but not their monomers)
• PPORD
• Regarded as Registered• Biocides
• Plant protection products
• Notified substances according to Directive 67/548/EEC
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 12
REACH Compliance Timeline
Sta
rt- u
p o
f E
uro
pe
an
Ch
em
ica
ls A
ge
ncy
(EC
HA
) –Ju
ne 0
7 to
Jun
e 08
2007 June
2008 June
2008 Nov
2010 Nov
2009 June
2013 June
2018 June
Registration of non-phase-in substances
Pre
-re
gist
ratio
n o
f su
bst
an
ces:
all
pha
se-i
n
Registration of substances:
- over 1000t pa: all substances
- over 100t pa: PBTsand vPvBs
- over 1t pa: CMRs
June 2008 to Nov 2010
Registration of substances:
- 100t to 1000t pa: all substances
Nov 2010 to June 2013
Registration of substances:
- 1t to 100t pa: all substances
June 2013 to Nov 2018
Pot
entia
l 6 m
onth
ex
tens
ion
for
DU
pr
e-re
gist
ratio
n of
su
bsta
nces
.
Ent
ry in
to F
orc
e
2006 Dec
Dire
ctiv
e a
do
ptio
n
Notification of substances in articles-S
tart
-up
of
Eu
rop
ea
n C
hem
ica
ls A
ge
ncy
(EC
HA
) -
June
07
to J
une
08
2007 June
2008 June
2008 Nov
2010 Nov
2009 June
2013 June
2018 June
Registration of non-phase-in substances
-P
re-r
eg
istr
atio
n o
f su
bsta
nce
s: a
ll p
hase
-in Registration of
substances:
- over 1000t pa: all substances
- over 100t pa: PBTs and vPvBs
- over 1t pa: CMRs
June 2008 to Nov 2010
Registration of substances:
100t to1000t pa: all substances
Nov 2010 to June 2013
Registration of substances:
1t to100t pa: all substances
June 2013 to Nov 2018
Pot
entia
l 6 m
onth
ex
tens
ion
for
DU
pr
e-re
gist
ratio
n of
su
bsta
nces
.
Ent
ry in
to F
orce
2006 Dec
Dire
ctiv
e ad
optio
n
Notification of substances in articles
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 13
Implications and Obligations Depend on …• Type of REACH product:
• Substance
• Preparation (mixture)
• Article with or without intended release
• Position in supply chain:
• Manufacturer or Importer
• Downstream User
• Distributor
• Geographical location (EU or non-EU) & organization of business units (legal entities)
• Substance classifications and volumes
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 14
Information Requirements of Manufacturers and Importers for Pre-Registration
• Identity of manufacturer/importer
• Substance identity
• Applicable tonnage band and “envisaged” deadline for registration
• For purposes of registration, multiple manufacturers will be grouped into SIEFs (Substance Information Exchange Forums)
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 15
Information Requirements for Registration• Identity of manufacturer/importer• Substance identity• Identified uses (Annex VI section 3)• Classification & labeling (Annex VI section 4)• Guidance on safe use (Annex VI section 5)• Study summaries (Annexes VII-XI)• Robust study summaries if required by
Annex I• Indication of information reviewed by an
“assessor”• Testing proposals (Annexes IX & X)• Exposure information (Annex VI section 6) for
substances in the 1-10 ton range• Confidentiality requests• Chemical Safety Report, if required
Key
Only submitted by the lead registrant
Other registrants may submit jointly or separately
Other registrants submit the remaining items after the lead registrant submits his dossier
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 16
Company Organizations Potentially Involved with REACH
• R&D/Product Development
• Production
• Sourcing/Supply Chain
• EHS
• Regulatory Affairs
• Legal
• IT
• Marketing
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 17
Compliance Actions To Take Right Now
• Identify role in supply chain
• Track and review evolving guidance
• Initiate communications with suppliers
• Develop inventory listing with information needed for pre-registration, registration, and/or notification
• Assess data gaps and prioritise substances for registration and notification
• Assess business risk of substances that may be removed from the market
• Identify roles, responsibilities and resources
• Identify and develop data management tools
Delivering sustainable solutions in a more competitive world
REACH Overview & Implications for Affinia, 15 July 2008, 18
Business Value of Effective REACH Management
• Reduced potential liabilities and risks related to regulation and litigation
• Coordinated and proactive response to current and future regulations
• Identification of opportunities for improvement of corporate environmental performance
• Market advantage through branding of environmentally friendly products and practices
• Streamlined testing, data collection, and data management requirements
• Integration of environmental considerations into all stages of the product life cycle