Transcript IBEC Education Committee Brussels, 8

REACH
Presented by:
Marian Byron, Director IBIA
Assistant Director PCI
What is REACH?
www.ibec.ie
 Commission proposal for a Regulation for
the management of chemicals
manufactured, imported, used and put on
the market in the EU
 A single system for the management of
non-phase-in (new) and phase-in (existing)
manufactured/ imported substances ”on
their own”, in preparations or in articles.
www.ibec.ie
What is REACH?
www.ibec.ie
 Registration, Evaluation, Authorisation
of Chemicals (REACH)
– Registration of substances of 1 tonne or more
per M/I/year
Data sharing and avoidance of unnecessary
testing
Information in the supply chain;
downstream users
– Evaluation of dossiers and substances by
Agency with Member State
– Authorisation for substances of high concern
Restrictions – the safety net
 Agency to manage the technical, scientific and
administrative aspects & to ensure consistency
Why do we need REACH?
www.ibec.ie
 Current system of chemicals
management inefficient
– 40 different pieces of
legislation
– different rules for new and
existing substances
– national public authorities
responsible
Inefficiencies of system cont.
www.ibec.ie
– lack of information about
30,000 (existing)
substances
concerns about the impact
of substances on public
health and the environment
How will the system work?
www.ibec.ie
 Responsibility now placed on industry
– Obligations on manufacturers, importers
and downstream-users of substances
– Key areas of responsibility for industry
Duty of Care
Data-sharing
Registration
Authorisation
Step 1: Definition of Role
www.ibec.ie
– An importer is any natural or legal person
established in the community who is responsible for
import into the Community
– A downstream user is any natural or legal person
established within the community…who uses a
substance either on its own or in a preparation
…Use means any processing,formulation,
consumption, storage, keeping, treatment, filling
into containers, transfer from one container to
another, mixing, production of an article or any
other utilisation.
Step 2: Definition of Responsibility
www.ibec.ie
 Manufacturers/Importers
– Duty to register each substance
manufactured or imported in quantities
of one tonne or more per year and
include information on M/I use in
registration
Substance in preparations in quantities
greater than one tonne per year but not
the preparation itself
Step 2: Definition of Responsibility
www.ibec.ie
 Downstream Users
– Inform their supplier of their or their customers use
so that the supplier can prepare exposure scenarios
for that use and appropriate risk management
measures
– Apply identified risk management measures and
recommend these measures to their customers
– If they want to keep their use confidential register
that use directly with the Agency
What is not under the scope of REACH
www.ibec.ie
 Radioactive substances
 Non-isolated intermediates
 Substances subject to customs
supervision (Art. 2 (1)(b)
 Substances in medicinal products for
human/vet use
 Food additives/flavourings
 Substances used in animal nutrition
 Active ingredients used in pesticides
and biocides (under biocides and
pesticides legislation)
What is not under the scope of REACH
www.ibec.ie
 Substances notified under Directive
67/548/EC as new substances
– but if next tonnage threshold is reached
more information will be required under
the REACH system
 Annex II and Annex III substances
(not considered to be of concern and
substances occurring in nature i.e. not
intentionally manufactured).
 Polymers: but non-registered
monomers in quantities >1t pa or 2%
of weight of polymer are (Council
definition!!)
What is not under the scope of REACH
www.ibec.ie
 Reimported substances (reimporter
becomes a DSU)
 Substances used in R&D
– assumption that will not be used in
quantities of >1 tonne per annum
 PPORD substances (substances
manufactured or imported for product
and process oriented research >1
tonne and limited customers)
– Exemption from registration for 5 years
and subject to information requirements.
Possibility of extension (max 10 years)
Step 3: Registration
Basis of REACH system
 No data – no market
 Register – substances, alone, in preparations,
in articles
 Initial prioritisation and timing based on
volume
– By 3 years after entry into force: >1000 tonnes
and CMRs and N; R50-53 over 100t
– By 6 years after entry into force: 100t- 1000t
– By 11 years after entry into force: 10-100t and 110t
 Need to assess information requirements which
are also based on volume
– More information and testing required for the
greater volume band
www.ibec.ie
Data Sharing: Preregistration/Information Sharing
www.ibec.ie
 Objective
– identify other potential registrants of the
same substance to share information and
avoid unnecessary testing
 Phase-in (existing) substances
– Must pre-register with Agency to continue
manufacturing/importing while preparing
registration dossier
– Deadlines
1.5 years after entry into force
Pre-registration
www.ibec.ie
 Information Requirements:
– Identify substance
– Identify manufacturer/importer
– Deadline for registration/tonnage band
– Physiochemical, toxicological and ecotoxicological information/studies
– Specification whether such studies
include vertebrate animal testing
Pre-registration
www.ibec.ie
 Substance Information Exchange
Forum (SIEF) set up by Agency to
facilitate data/cost sharing for
registration of same substance
 Sharing of vertebrate animal testing is
mandatory
 Consortia may be formed to prepare
registration dossier but individual
must register in interests of business
confidentiality
Non-phase-in (New) Substances
www.ibec.ie
 Potential registrant checks with the Central
Agency whether the substance has already
been registered or whether there is another
potential registrant
– If not previously registered registrant may conduct
tests involving vertebrate animal testing
– If substance registered more than ten years
previously the Agency makes available to the
potential registrant any relevant data
– If substance registered <10 years previously the
Agency facilitates contact with previous registrant
with a view to sharing data and contributing
towards first registrants costs
Registration Dossier
www.ibec.ie
 Information requirements
– 1- 10 tonnes: technical dossier
– Higher volumes: greater information requirements
and testing proposals if existing information is
insufficient
– Testing programmes are completed by the National
Competent Authority
 Chemical Safety Report
– >10 tonnes
– Chemical Safety Assessment
Physiochemical and human health hazard
assessment
Chemical Safety Report
www.ibec.ie
Human Health
Environmental Hazard Assessment
PVT and vPvB assessment
If dangerous
– Exposure assessment and exposure
scenario generation
 Exposure Scenarios
– Required for
 Manufacture
 Manufacturer or importers own use
 any identified downstream use
Chemical Safety Report
www.ibec.ie
– Describes risk reduction measures
implemented by M/I and those
recommended to downstream users
– Covers the life-cycle of the substance
– Summarised in CSR and annexed to the
Safety Data Sheet
Downstream Users
www.ibec.ie
 Where a downstream user has
identified its use the M/I CSR must
cover that use
 If decide not to make that use known
to the supplier
– perform hazard assessments only for
‘unidentified uses’ (using supplier hazard
information
– inform Agency of / directly register the
unidentified use of substances >1 t
Information through the supply chain
www.ibec.ie
 Objective
– Improve the communication of risk management
measures up and down the supply chain
 How
– Safety Data Sheet with information from CSR
(exposure scenarios and corresponding risk
reduction measures)
– Information on authorisation and restriction of
substances
– Information up the supply chain on new hazards
Step 4: Evaluation
www.ibec.ie
 Two forms of evaluation
– Dossier evaluation
– Substance evaluation
 Dossier Evaluation
– Completeness check of Registration
dossier- Central Agency
– Compliance with dossier requirements Comp auth.
– Check of testing proposals- comp auth.
Evaluation
www.ibec.ie
 Substance Evaluation
– Examination of a substance of concern and
its environment/public health impact
– Competent Authority responsibility for
identifying substance and notifying for the
purposes of Central Agency rolling plan
– Further information may be required from
registrant
– Can lead to authorisation/restriction process
Step 5: Authorisation/Restriction
www.ibec.ie
 CMRs, PBTs and vPvBs are automatically
subject to authorisation
 Applies to a M, I, DU who places a
substance on the market for a use or uses
it himself
 No volume threshold, registration not
required
 Authorisation for use may be granted if
considered to be adequately controlled or
if socio-economic benefits outweigh risk
 Substitution Plan may be required
Other Steps: Classification and
Labelling Inventory
www.ibec.ie
 Inventory
– Information on classification and
labelling for all marketed substances
– Deadline to submit data: 3 years after
entry into force
– Managed by Central Agency
– Where DU C&L differs to M/I report to
the Central Agency
Impact of REACH on Industry
www.ibec.ie
 Additional Impact Assessments
– Removal of substances from the supply
chain
– Impact on innovation
– Impact on new member states
 SPORT: Strategic Partnership on
REACH Testing
 RIPs
www.ibec.ie
Decision-making process
www.ibec.ie
 Current state of play
– First reading in the Parliament
– Council Ad-Hoc Working Group
 Expected/Timetable
– Complete first reading end 2005
– Adoption of final text end 2006/2007
– Entry into force 2007
Authorisation
www.ibec.ie
 Time limited authorisation
 Substitution plans
 Carcinogenic, mutagenic, PBTs, vPvB,
endocrine disruptors
 Risk/Benefit
 Adequate control
 Account of nature, dispersion, volume
GHS
www.ibec.ie
– entry into force at same time as REACH
– Applies to substances and mixtures
– Lays down the provisions on the classification as hazardous
and on labelling and packaging
– General rules
 The label shall include the following elements
 Hazard pictograms; signal words; hazard statements;
product identifier; name, address and telephone number;
precautionary statements
 Rules where to place label elements not yet included in
the GHS
 European Commission GHS web site
 http://europa.eu.int/comm/enterprise/reach/ghs_en.htm
REACH and the GHS – Scope comparison
www.ibec.ie
REACH
R,E,A,Ch
Risk
Substances Produced
Hazardous and Non-Hazardous
> 1 Tonne per Manufacturer
Harmonised Classifications
GHS
Classification, Labelling, SDS
Hazard
Substances/Mixtures
Hazardous
Any volumes
Self Classification
CMRs at EU Level
Other Endpoints - Industry
European Union
Supply
Global
Supply and Transport
GHS / EU – similar framework
with differing elements
www.ibec.ie
 The GHS is similar to the
current EU system:
 The GHS is different to
the current EU system:
 It provides for one single
system for hazard
classification and
labelling
 It defines further hazard
classes and categories
 It covers approximately
the same hazards
 It uses partly other
criteria and other cut-offs
 It often uses similar or
equal classification
criteria
 It uses a different
approach for mixtures
 It sets up an equivalent
system of hazard
communication
 It classifies some hazards
in more than one class
 It changes some labelling
elements
GHS – what is new and what is different
www.ibec.ie
 Additional hazard classes and/or categories, e.g.
flammable liquids cat. 4, oxidising liquids and solids cat. 2
and 3, corrosive to metals, flammable aerosols, self-reactive s&m, gases
under pressure, s&m which, in contact with water, emit flammable gases,
acute toxicity cat. 5, TOST, skin irritation cat. 3, hazardous to the aquatic
environment
 „Cross-classification“
– E(R2, R3) to explosives, self-reactive s&m and organic peroxides
– O (R8, R9) to oxidising solids and oxidising liquids
– F (R17) to pyrophoric liquids, pyrophoric solids and self-heating s&m
GHS – what is new and what is different
www.ibec.ie
 Additional hazard classes and/or categories, e.g.
flammable liquids cat. 4, oxidising liquids and solids cat. 2
and 3, corrosive to metals, flammable aerosols, self-reactive s&m, gases under
pressure, s&m which, in contact with water, emit flammable gases, acute toxicity cat.
5, TOST, skin irritation cat. 3, hazardous to the aquatic environment
 „Cross-classification“
– E(R2, R3) to explosives, self-reactive s&m and organic peroxides
– O (R8, R9) to oxidising solids and oxidising liquids
– F (R17) to pyrophoric liquids, pyrophoric solids and self-heating s&m
GHS – what is new and what is different
www.ibec.ie
 Other criteria or other cut-offs
– e.g. for explosives (criteria), acute toxicity (cut-offs), reproductive
toxicity (cut-offs for mixtures), skin irritation / corrosion, serious eye
damage / eye irritation
 Different approach for mixtures (EU: preparations)
– decision logic including testing, bridging principles, calculations
– different calculation approach for acute toxicity, skin corrosion /
irritation, serious eye damage / eye irritation, hazardous to the aquatic
environment
GHS – what is new and what is different
www.ibec.ie
 Different / additional label elements, i.e..
– pictograms, signal words, hazard statements and codification, precautionary
statements and codification; examples:
– No indications of danger, but signal words „Danger“ and „Warning“
– Hazard and precautionary statements and their codifications are currently under
discussion at the UN SCE
www.ibec.ie

Element: Woman
Symbol: Wo
Discoverer: Adam
Atomic Mass: Accepted as 50 Kg, but varies from 45 Kg to 250 Kg
PHYSICAL PROPERTIES.
1.- Surface usually lined with painted film (in the order of 0-6m to 0-3m).
2.- Boils at nothing, freezes without reason.
3.- Melts if given special treatment.
4.- Bitter if used incorrectly.
5.- Found in various states ranging from virgin metal to common ore.
6.- Yields to pressure applied at the correct points.
CHEMICAL PROPERTIES.
1.- Has great affinity for gold, silver, platinum and precious stones
2.- Absorbs large quantities of expensive substances.
3.- May explode spontaneously without prior warning and for no reason.
4.- Insoluble in liquids, but alcohol saturation increases activity.
5.- Most powerful income-reducing agent known to man.
COMMON USE.
1.- Highly ornamental, especially in sports cars.
2.- Can be a great aid to relaxation.
4.- Useful for general cleaning, scrubbing, washing, rubbing, etc.
TEST.
1.- Pure specimen turns pink when discovered in the natural state.
2.- Turns green when placed next to a better specimen.
HAZARDS.
1.- Highly dangerous except in experienced hands.
2.- Illegal to possess more than one.
www.ibec.ie
www.ibec.ie


Element: Man
Discoverer: God ( responsibility rests with producer)
Atomic Mass: Accepted as 75 Kg, but varies from 65 Kg to 250 Kg
PHYSICAL PROPERTIES.




1.2.3.4.5.6.-
Varies from irregular, smooth, toned and covered with bristles.
Slow to react and quite inert unless suitably activated (going for a pint?)
Melts when appropriately flattered and adored
Bitter if impeded in forming mixtures with similar bodies (i.e. drinking/football buddies)
Found in various states from immobile, intoxicated, dormant, at work.
Impervious to pressure of any subtle variety, need strong pressure of very clear intent.
CHEMICAL PROPERTIES.

1.2.3.5.-
Has great affinity for alcohol, rounded polymeric materials, non ionizing radiation (TV)
Absorbs large quantities of carbonaceous materials, and OH molecules.
May explode after long latency periods of inertia, without prior warning
Most powerful labour demanding agent known to woman
COMMON USE.



1.- Highly effective particularly in commenting on global and national affairs (late at night particularly)
2.- Can be a great aid to encouraging exercise (cleaning etc)
4.- Useful for (still to be fully identified)
TEST.
1.- Pure specimen reacts violently to saline (particularly tears) which can promote direct repellant
reaction
2.- Turns green when placed next to man attached to better female specimen or CAR.
HAZARDS.
1.- Highly dangerous except in experienced hands.
2.- Impossible to handle more than one.