Transcript REACH- EU New Chemicals Policy

REACH- EU New Chemicals Policy
Presentation to the European Aerosol Federation
28 September 2005
Athens Greece
Deborah Hotchkiss, SC Johnson
REACH – 5 key points
1. Biggest piece of chemical legislation ever
to hit the EU
2. Will impact all of our products
3. Will impact all chemicals we use
4. Will impact all of our suppliers
/distributors
5. Failure to respond adequately puts the
chemical industry at risk in the EU
REACH – History
•
1998 – informal meeting of Environment
ministers
•
2001 – Commission White Paper
•
May 2003 – draft Commission proposal
for consultation
•
October 2003 – Commission proposal
•
2004 onwards – over to Council of
Ministers and European Parliament
REACH-
Registration, Evaluation and Authorisation of CHemicals
• Overall goal is to address concerns over
the potential effects of chemicals on
human health and environment
• Also aims to eliminate the data differences
between new and existing chemicals
• “New chemicals” are those put on the
market post 1981
Significant increase in chemicals in the EU
• Volume of chemicals in the EU has
increased by 400 times during last 70 years
The current legislation on chemicals puts
Many more obligations on
new chemicals
0.01%
Than on
existing chemicals
Volume on market
99.99%
REACH principles
• Make industry responsible for safe use of chemicals
• Extend the responsibility along the manufacturing
chain (downstream users will be involved)
• Encourage consortia to share data, costs and avoid
animal testing
• Promote substitution of hazardous chemicals
• Make information publicly available
Scope
• Each manufacturer (located in the EU) or importer
(from outside EU) of a substance in a volume of
one ton or more per annum (tpa) must submit a
registration (includes natural substances)
• Downstream users can register for a specific use
• Responsibility shifts to Industry
Exemptions
• No obligation to register:
–Medical products for humans and veterinary use
–A food additive
–A flavoring substance
–Substances used for animal nutrition
–Preparations (must register substances
manufactured or imported greater than 1 ton
that are in the preparation)
–Exemption for cosmetic use (consumer safety
covered by Cosmetics Directive)
A complex process
Downstream Users
(6 information elements)
Registration
General
Requirement
8 information
elements
OR
>1 Tonnes
(includes transported
isolated intermediates
above 1000 TPY)
24 data elements(2)
Special
Requirements
Deferrals
- PPORD
(5 information
elements)
- Phase-in
Substances
>10 Tonnes
+Chemical Safety Rpt.
37 data elements (2),
6 assessments; 16
evaluations
Periodic
Obligations
(7 information
elements)
Restrictions
Articles
- Intended Release:
(8 information elements)
-Unintended Release:
Notification - (6 information
elements)
Dossier
Evaluation
Examine
Test
Proposals
Compliance
Check
Substance
Evaluation
Rolling Plan
Additional
Info from
Producers
Addt’l. Data
Intermediates
-Site limited (4 information
elements)
-Transported (4 information
elements)
Draft
Decisions
to Agency
Agency or
Member
State
Initiates
Prepare
Dossier
Agency
Risk
Assessmen
t
Socioeconomic
Analysis
8 elements
OR
>100 Tonnes
+Chemical Safety Rpt.
56 data elements (2),
6 assessments, 16
evaluations
OR
>1000 Tonnes
+Chemical Safety Rpt.
62 data elements (2),
6 assessments
16 evaluations
Authorization
Animal Test Plans
(1 assessment)
SDS (16 data elements)
OR
Evaluation
Preregistration of Phase-in
Substances
(5 information elements)
Info Down Supply Chain if no
SDS (4 information elements
& 4 update requirements)
1 Major processes with requirements for
industry (does not include all REACH
provisions)
2 Maximum number; actual requirements
are substance dependent
3 Exemptions from Registration
- Medicinal Products
- Food Additives
- Food Stuffs & Feeding Stuffs
- Animal Nutrition
Agency or
Member
State
Recomm.
Commissio
n
Decision on
Restriction
- Annexes II & III
- substances in Plant Protection
Products
- Active Substances in Biocidal
Products
- Polymers
Listed & Criteria
Substances
Producers
Application
3 information
requirements
Risk
Assessment
1 analysis + CSR
Alternative
Analysis
6 elements
Socioeconomic
Analysis
8 elements
Agency
Assessment
List on
Annex VIII
Registration
• Affects all chemicals manufactured or
imported into the EU greater than 1 tpa
• Manufacturer or importer is responsible
• Requires dossier stating:
–End uses of the material
–Physio-chemical, toxicological and
ecotoxicological data specific to the risk
associated with the end use
Registration deadlines*
• 2010: All chemicals sold in quantities
>1000 tpa & Carcinogenic,
Mutagenic or Reprotoxic (CMR)
• 2013: All chemicals sold in quantities
100-1000 tpa
• 2017: All chemicals sold in quantities
1-100 tpa
* If legislation not finalised in 2007, then
these dates will alter
Evaluation
• Performed by the member states
• Two types of evaluation:
– Dossier Evaluation
Alternatives to animal testing and
literature reviews
– Substance Evaluation
Performed if the substance poses a
risk to human health or environment
Authorisation
• If substance, when evaluated, is found to
be of high concern it cannot be used
without Authorisation
• Risk must be “adequately controlled”
• Socio-economic benefit must be shown
• Supplier/user must be actively researching
a substitute
Status
WE ARE HERE
New
Parliament
Summer '04
2001
White
paper
2003
New
Commission
January '05
2004
Commission
Opinion (?)
2005
2006
Commission
Proposal
Internet
Consultation Oct 29, 2003
Second
Parliament
Reading (?)
Plenary
First
First
Voting
UK
Parliament
Council
Amendments
Presidency
Reading
Parliament Position (?)
Deadline
for
Starts
End 1st reading
End U.K.
Amendments
Amendments
Presidency
via Parliament
Compromise
2005
F
M
A
M
2007
J
J
A
S
O
N
D 2006
Second
Council
Position (?)
Final
Legislation
(??)
EU Political Scene - Council
Jan ‘04 – Jun ‘04
Jul ’04 – Dec ’04
Jan ‘05 – Jun ‘05
Jul ’05 – Dec ‘05
Ireland
Netherlands
Luxembourg
UK
High Level Reading
Scope & Registration
Evaluation
Authorization
Agency
Enforcement
UK Presidency:
• REACH = high priority
• good cooperation with Parliament
• goal: 1st position by Council before end 2005
• main concerns:
1) Competitive Industry
2) Workable REACH
3) Minimize Animal Testing
Overview
• 100,000 existing chemicals on EINECS
• 30,000 require Registration
• Estimated 1 in 5 of the chemicals
Registered will need to be Evaluated
• 1,500 will require Authorisation
Definition of “Downstream User”
• Any legal person, other than the
manufacturer or the importer, who uses a
substance (either on its own or in a
preparation) in the course of his industrial
or professional activities
• A distributor or a consumer is not a
downstream user
Responsibilities of the Downstream User
• Downstream Users need to
–Communicate identified uses to suppliers
–Implement suppliers RRM for identified
uses
–Perform chemical safety assessments for
unidentified uses
–Inform agency of unidentified uses
>1 tonne/year
Cost implications for Downstream Users
• Estimated cost to all Downstream users of
chemicals is €2.8 - 5.2 billion
• EU estimate 1-2% of chemicals could be
withdrawn as production would not be
profitable
• Chemical Industry estimate up to 40% of
chemicals on the EU market could be
withdrawn
Probable impact on consumer product industry
1. Need for administration
& expert resources
2. Cost of chemicals
will increase
Potential impact on consumer product industry
3. More substances Classified
as “dangerous”
• Less choice….
• Adverse labelling on
products
• Potential PR issue
• Stricter packaging
requirements
• More administration in the
factories
• etc…
• Less flexibility to innovate
• Re-formulation of brands
Questions?
Thank you for your time
Deborah Hotchkiss
[email protected]
+44(0) 1784 484 4250