reach presented by:marian byron, director ibia assistant director pci
TRANSCRIPT
REACH
Presented by: Marian Byron, Director IBIA Assistant Director PCI
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What is REACH?
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.
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What is REACH?
Registration, Evaluation, Authorisation of Chemicals (REACH)– Registration of substances of 1 tonne or more
per M/I/yearData sharing and avoidance of unnecessary
testingInformation 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
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Why do we need REACH?
Current system of chemicals management inefficient– 40 different pieces of
legislation– different rules for new
and existing substances– national public
authorities responsible
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Inefficiencies of system cont.
– lack of information about 30,000 (existing) substances concerns about the impact of substances on public health and the environment
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How will the system work?
Responsibility now placed on industry– Obligations on manufacturers,
importers and downstream-users of substances
– Key areas of responsibility for industryDuty of CareData-sharingRegistrationAuthorisation
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Step 1: Definition of Role
– 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.
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Step 2: Definition of Responsibility
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 registrationSubstance in preparations in
quantities greater than one tonne per year but not the preparation itself
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Step 2: Definition of Responsibility
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
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What is not under the scope of REACH
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)
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What is not under the scope of REACH
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!!)
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What is not under the scope of REACH
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)
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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 1-10t
Need to assess information requirements which are also based on volume– More information and testing required for the greater
volume band
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Data Sharing: Pre-registration/Information Sharing
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
– Deadlines1.5 years after entry into force
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Pre-registration
Information Requirements:– Identify substance– Identify manufacturer/importer– Deadline for registration/tonnage
band– Physiochemical, toxicological and
eco-toxicological information/studies
– Specification whether such studies include vertebrate animal testing
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Pre-registration
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
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Non-phase-in (New) Substances
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
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Registration Dossier
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
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Chemical Safety Report
Human Health Environmental Hazard AssessmentPVT and vPvB assessmentIf dangerous
– Exposure assessment and exposure scenario generation
Exposure Scenarios – Required for
ManufactureManufacturer or importers own useany identified downstream use
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Chemical Safety Report
– 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
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Downstream Users
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
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Information through the supply chain
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
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Step 4: Evaluation
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.
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Evaluation
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
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Step 5: Authorisation/Restriction
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
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Other Steps: Classification and Labelling Inventory
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
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Impact of REACH on Industry
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
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Decision-making process
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
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Authorisation
Time limited authorisation Substitution plans Carcinogenic, mutagenic, PBTs,
vPvB, endocrine disruptors Risk/Benefit Adequate control Account of nature, dispersion,
volume
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GHS
– 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
www.ibec.ieREACH and the GHS – Scope comparison
REACH GHS
R,E,A,Ch Classification, Labelling, SDS
Risk Hazard
Substances Produced Substances/Mixtures
Hazardous and Non-Hazardous Hazardous
> 1 Tonne per Manufacturer Any volumes
Harmonised Classifications Self Classification
CMRs at EU Level
Other Endpoints - Industry
European Union Global
Supply Supply and Transport
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GHS / EU – similar framework with differing elements
The GHS is similar to the current EU system:
It provides for one single system for hazard classification and labelling
It covers approximately the same hazards
It often uses similar or equal classification criteria
It sets up an equivalent system of hazard communication
The GHS is different to the current EU system:
It defines further hazard classes and categories
It classifies some hazards in more than one class
It uses partly other criteria and other cut-offs
It uses a different approach for mixtures
It changes some labelling elements
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GHS – what is new and what is different
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
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GHS – what is new and what is different
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
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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
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GHS – what is new and what is different
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
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www.ibec.ie Element: Woman
Symbol: WoDiscoverer: AdamAtomic 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 stones2.- 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.
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Element: ManDiscoverer: God ( responsibility rests with producer)
Atomic Mass: Accepted as 75 Kg, but varies from 65 Kg to 250 Kg
PHYSICAL PROPERTIES.
1.- Varies from irregular, smooth, toned and covered with bristles. 2.- Slow to react and quite inert unless suitably activated (going for a pint?) 3.- Melts when appropriately flattered and adored
4.- Bitter if impeded in forming mixtures with similar bodies (i.e. drinking/football buddies)
5.- Found in various states from immobile, intoxicated, dormant, at work. 6.- Impervious to pressure of any subtle variety, need strong pressure of very clear intent.
CHEMICAL PROPERTIES.
1.- Has great affinity for alcohol, rounded polymeric materials, non ionizing radiation (TV) 2.- Absorbs large quantities of carbonaceous materials, and OH molecules.
3.- May explode after long latency periods of inertia, without prior warning 5.- 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 reaction2.- 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.