registration, evaluation, authorisation and restriction of chemicals regulations reach
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Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations REACH. Cathy Phillips CEng IMechE CMIOSH AIEMA HSE Materials Manager, Corporate HSE. Rolls-Royce plc. Power for air, sea and land - PowerPoint PPT PresentationTRANSCRIPT
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©2008 Rolls-Royce plcThe information in this document is the property of Rolls-Royce plc and may not be copied or communicated to a third party, or used for any purpose other than that for which it is supplied without the express written consent of Rolls-Royce plc.
This information is given in good faith based upon the latest information available to Rolls-Royce plc, no warranty or representation is given concerning such information, which must not be taken as establishing any contractual or other commitment binding upon Rolls-Royce plc or any of its subsidiary or associated companies.
Title - Arial 28ptRegistration, Evaluation,
Authorisation and Restriction of Chemicals Regulations
REACH
Cathy Phillips CEng IMechE CMIOSH AIEMA
HSE Materials Manager, Corporate HSE
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Rolls-Royce plc
Power for air, sea and land Customers; 500+ airlines, 4,000 corporate and utility
aircraft and helicopter operators, 160 armed forces and more than 2,000 marine customers, including 50 navies. Energy customers in nearly 120 countries.
Annual sales over $10 billion 35,000 employees; 21,000 in UK, 8,000 in North
America and 5,000 in rest of Europe
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REACH and YOU
Overview of REACH Legal obligation 1 – pre-registration
through to authorisation Pre-registration Registration Authorisation & restriction
Legal obligation 2 - Declaration Business Risk Action Plan / Governance
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Objective
To identify the business and legal risks associated with REACH.
To assess the overall scale of the task for each of your legal entities.
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Business Risks and REACH
REACH could result in some of the substances used to make manufactured products being:
Unavailable, if suppliers (manufacturers / importers) do not register the substances.
Increasingly difficult to obtain in the long term, if they are hazardous.
More costly to buy (because of the registration and authorisation costs).
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ManufacturePlacing on the market
Use
Importation
Importation
REACH scope
of substances
On their own
Trichlorethylene
In preparations
Paints, Sealants, Resins
In articles
Systems, Components, aircraft
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REACH Key Words
Substance: A basic chemical, like iron, nickel, trichloroethylene, lead oxide
Preparation: A mixture of chemicals, like steel, adhesive, resin, paint, an etchant, an NDT fluid
Article: An object where the shape is more important than its chemical composition: A billet, a rod, a diesel engine, a gasket, a spare part, a submarine, a valve, a second hand product
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Who does REACH apply to? Any Company (LEGAL ENTITY)
producing, importing, using or placing a substance, preparation or article on the EU market must comply with REACH.
Covers EU manufacturers, including chemical suppliers, distributors and downstream users.
Covers EU enterprises importing products to the European Community
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Supply Chain and manufacturing use of Substances
REACH – legal overview
Pre-registration
Import substances into EU >1tonne/year
Registration
Pre Registrants to submit Safety Assessment for
each specific use of substance
Evaluation
By ECHA.For several substances this may already exist
Authorisation
to use in specific application
Restriction
Declaring Substances of Very High Concern in Articles to customers
Substances of very High Concern (Candidate list)
Supplier Rolls-Royce Customer0.1% of SVHCs
In Articles0.1% of SVHCs
In Articles
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Supply chain communication
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Supply Chain and manufacturing use of Substances
REACH – legal overview
Pre-registration
Import substances into EU >1tonne/year
Registration
Pre Registrants to submit Safety Assessment for
each specific use of substance
Evaluation
By ECHA.For several substances this may already exist
Authorisation
to use in specific application
Restriction
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Pre-Registration in REACH
Manufacturers and IMPORTERS (M/I) of substances have to register them.
This will MAINLY be chemical manufacturers and suppliers.
Many substances can benefit from an 11 year phase in of registration, if they are Pre-registered BETWEEN JUNE AND END NOV.
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Continuity of supply: Will your suppliers (particularly
distributors and stockists who are
importers) meet their legal obligations?
Continued legal use: Will the manufacturer or importer (who
could be several tiers up), include your use
in their registration?
Implications of Registration on Downstream Users…
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Safety Data Sheetsinversion of Sections 2&3 + email contact
Persistent, Bioaccumulative and Toxic substances (PBT) and very persistent / very bioaccumulative substances
(VPVB) will NOT be shown (initially)
Will require an “extended SDS” following registration (e-SDS) which will MANDATE the way in which the
substance / preparation is used.
Title IV - Information in the Supply Chain
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DUs need to: communicate use upstream(min 12 months prior to phase-in registration deadline)
distributors have responsibility to pass information up and down between DUs and manufacturers / importers
DU Chemical Safety Assessmentfor uses outside an Exposure Scenario (or use & exposure category)
DU exceptions (e.g. <1 tonne per year)
General compliance (max 12 months) Reporting of information (max 6 months)
Title V - Downstream Users
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The Evaluation in REACH
Once pre-registered, manufacturers and importers of substances have to prepare DOSSIERS that will be EVALUATED by the REACH Agency in Helsinki.
This will decide whether registered substances are ‘nasties’(substances of very high concern). If they are, then the European Commission could require them to go through Authorisation or Restriction.
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Supply Chain and manufacturing use of Substances
REACH – legal overview
Pre-registration
Import substances into EU >1tonne/year
Registration
Pre Registrants to submit Safety Assessment for
each specific use of substance
Evaluation
By ECHA.For several substances this may already exist
Authorisation
to use in specific application
Restriction
Substances of very High Concern (Candidate list)
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“Substances of Very High Concern”
Carcinogens, mutagens and reproductive toxins (CMRs)
Persistent, Biocumulative and Toxic (PBT)Very persistent and very bioaccumulative
(vPvB)Substances of equivalent concern
(endocrine disruptors)
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This list is intended to: Help companies make product
and process decisions, whilst complying with regulatory and customer requirements.
Enable the business risk from these substances to be managed throughout a supply chain
It is intended primarily for the aerospace defence sector
http://www.asd-stan.org
TR 9535 and TR 9536
The Declarable Substances list
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Substances in our Products and Processes
Declarable SubstancesSAE standard
All substances
Candidate List
AnnexeXIV
Relevant to YOUR business
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The Declarable Substances listA compilation of all the substances that have
been identified as being…CMRs category 1& 2 (annex 1 of directive 67-548
as amended)
Substances defined as vPvB or PBT (OSPAR
listed substances)
Ozone Depleting Substances as defined by
Montreal ProtocolPersistent Organic Pollutants as defined by the
Stockholm Convention, etc. Substances listed within Annex XVII (restricted
substances)
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Substances in our Products and Processes
Declarable SubstancesSAE standard
All substances
Candidate List
AnnexeXIV
Marine relevant
High Risk
Declaration from supply chain by no
later than end 2010?
Declaration from supply chain asap
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Supply Chain and manufacturing use of Substances
REACH – legal overview
Pre-registration
Import substances into EU >1tonne/year
Registration
Pre Registrants to submit Safety Assessment for
each specific use of substance
Evaluation
By ECHA.For several substances this may already exist
Authorisation
to use in specific application
Restriction
Declaring Substances of Very High Concern in Articles to customers
Substances of very High Concern (Candidate list)
Supplier Rolls-Royce Customer0.1% of SVHCs
In Articles0.1% of SVHCs
In Articles
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Articles
Registration = if intended release
Notification = if ‘Candidate List’ & >0.1% w/w
& cannot excluded exposure
unless already registered for that use
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Requirement to Inform Customers and the Consumer
You have a legal obligation to INFORM Customers about SVHCs contained within YOUR product (Article 33(1))
> 0.1% w/w
“sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance”.
Same information to be available free of charge to consumers on request (within 45 days)
Your suppliers also have this obligation if they are located in the EU.
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Requirement to Notify of SVHCsYou have a legal obligation to NOTIFY the REACH Agency (ECHA) AND Customers about SVHCs contained within YOUR product (REACH Article 7(2)) if the following apply:
>0.1% w/w AND
> 1 tonne sold (of SVHC per year) AND
Cannot show that the substance will not be released at any point in the life cycle (including disposal)
This is a subset of the information needed for the customer
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REACH and business risk…
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Issues within the Supply Chain
Supply chain… Issue…
Changing formulations
Quality concerns.
In our sector, it could invalidate aircraft
safety certification (European Aircraft
Safety Agency)
Withdrawal of formulation
Need to find and prove alternatives to satisfy
Quality (& Certification) requirements
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Issues within the Supply ChainSupply chain… Issue…
Failure to register / Failure to check that
the substance is being registered for their use
Substance could be lost
Too specific or too general information on uses in the Chemical
Safety Report
Checking that substances are being used legally will be a laborious exercise
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Issues within the Supply Chain
Supply chain… Issue…
Lack of information about substances in
formulations
Unable to check that formulation is being
used legally
Lack of information about substances in
articles
Unable to meet legal obligations to provide information on SVHCs
to customers
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ACTIONS: Hold your own internal workshops:
1. Dealing with the Registration process: 1. Manufacturer, importer or downstream user?2. What do you buy from where?3. What action is needed prepare for
preregistration/registration? 4. What are the SVHCs used in your factories?
2. Dealing with the “Declaration” part of REACH: 1. What are the declarable substances (as a surrogate for
SVHCs) in your products?
3. What are the risks from REACH to you?1. Continuity of supply? 2. Ability to adapt to the loss of substances?
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Step 1: What are YOUR responsibilities in REACH?
1. What substances / preparations do you use?
2. Which of these are imported?– Find out if what you are buying is
imported by YOUR company or someone else.
– If it is YOU, ask the non-EU supplier if they intend to have an ‘only representative’. YOU have a legal obligation to pre-register if you import! YOU NEED TO ACT NOW!
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Step 2: Engagement with Suppliers
If you want to maintain access to chemicals & raw materials, it is vital that the supplier understands their responsibilities. DEFRA estimates that more than 60% of businesses have not even heard of REACH.
What should you do about it?1. Most of your supply chain is probably unaware
about REACH. So TELL THEM.
2. Are they organised for REACH?: Check! EXAMPLE LETTERS ARE AVAILABLE
3. Will your supplier take care of you?: ASK!
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ACTION: Have the suppliers you deal with heard of REACH?
1. Compile a list of your suppliers, and where they are. Include addresses.
2. Write to all your suppliers telling them about REACH.
3. Ask each supplier who their REACH FOCAL POINT is.
4. Keep a record on who has replied, and the names / email addresses of the
focal points.
ANSWERS WILL BE:
“Don’t worry, we will pre-register/register”. - You are OK!
“We will not be registering” - You need to change supplier / product!
“Silence”: we don’t know what you are talking about - You need to educate
your supplier!
Step 2: Engagement with Suppliers
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Dealing with “silence”!
1. Recommend that your suppliers go on a training day on
REACH.
2. Most sectors offer training on REACH – they should go on
one relevant to them.
• EEF,
• HSE,
• British Coatings Federation,
• Institute of Metal Finishing etc.
Step 2: Engagement with Suppliers
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Step 3: Estimate the risk
EU stockists / distributors / agents…–Most distributors and stockists who are
importers ARE UNAWARE OF THEIR OBLIGATIONS (according to UK HSE & DEFRA).
–Many smaller stockists intend to stop supplying, because of the costs!!
–Will this be the case for your supply chain?–What is the threat to your continuity of
supply?
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Step 3: Estimate the risk
EU manufacturers of substances, formulators of preparations…
– If the substance is a small sales stream for them, it may not be cost effective for them to keep making it.
–Does this affect any substances, or constituents in preparations, that you need?
–Will formulators change the ingredients in the preparations they sell you (do you care?)
–What is the threat to your continuity of supply?
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Step 4: Record what you learn
For substances & preparations, make a spreadsheet of…
The tradenames / specs of the chemicals you buy Where and who you buy them from (import?) How much you buy Whether the supplier knows about REACH Who their focal point is Their contact details Whether we are the importer If there is an only representative
To prove ‘due diligence’ to regulators To help senior managers make decisions!
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Step 5: Up to date COSHH inventories
CHECK that all substances / preparations you buy are supplied with a MSDS, and check that it goes to your HSE people.
Are there people outside purchasing that have delegated authority to purchase substances and preparations?
How do you ensure these people get the MSDS to the HSE team?
Tighten up these processes!
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Step 6: SVHCs
Your company needs to be able to tell customers and ECHA about all SVHCs within the products you make.
To do this, you need the information for all products you BUY, where they are…
– PREPARATIONS that we incorporate into the product– ARTICLES that we incorporate into the product
In the absence of any other list, you can use the ‘declarable substances list’ from the SAE standard.
– Watch for the issue of the first ‘candidate list’!
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Step 7: Authorisation
From next year, your company will need an ‘authorisation’ for continued use of SVHCs put onto the candidate list and transferred onto ANNEX XIV of REACH.
– 50,000 Euros per authorisation per use– Paperwork (Like COMAH) for the application process
The need for this will be stated on the MSDS.
For these substances, substitution plans are mandatory.
Start planning for these changes
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Other sources of guidance and advicehttp://www.reachready.co.uk General Manufacturing Industry:http://www.orgalime.org/publications/guides/reach.htm Aviation/Automotive Industry:http://www.asd-europe.org/Content/Default.asp?PageID=41http://www.sbac.co.uk/community/cms/content/preview/news_item_view.asp?i=17018&t=0 Chemicals Industry:http://www.reachcentrum.org/ Coatings Industry:
http://www.coatings.org.uk and search on OutREACH
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Official sources of guidance and adviceECHA WEBSITE:http://ec.europa.eu/echa/home_en.html European Commission:http://ecb.jrc.it/reach/ DEFRA:http://www.defra.gov.uk/corporate/consult/reach-enforce/index.htm HSE: THE UK ‘Competent Authority’:
0845 408 9575 [email protected]