overview & implications for affinia registration, evaluation, and authorisation of chemicals

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



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



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)



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



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



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



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



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



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



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



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


- 100t to 1000t pa: all substances

Nov 2010 to June 2013


- 1t to 100t pa: all substances


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



100t to1000t pa: all substances

Nov 2010 to June 2013


1t to100t pa: all substances


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



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



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)



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



Company Organizations Potentially Involved with REACH

• R&D/Product Development

• Production

• Sourcing/Supply Chain

• EHS

• Regulatory Affairs

• Legal

• IT

• Marketing



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



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

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