©2008 rolls-royce plc the information in this document is the property of rolls-royce plc and may...
TRANSCRIPT
©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.
Taking Action!Registration
Evaluation Authorisation (and Restriction) of Chemicals.
Taking Action on REACH
Cathy Phillips, HSE Materials Manager
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Getting organised to manage REACH
1. Engaging senior management by answering the Question: Why should I care about REACH?
• Objective: Briefing senior managers so that they release the resources needed to manage the business risk associated with REACH.
2. What are the business risks?
• Objective: To assess the risks in your own context, to decide how much your business and your supply chain could be affected.
3. What should the business plan be, to help me manage the business risks?
• Objective: Many sectors and businesses have already created plans and obtained resources and are working on REACH. Lets take this and apply it to you.
2
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACH
REACH will have BENEFITS for human health, and the environment because some really hazardous chemicals in use on their sites will not be allowed in future.
• More information will be available about the hazards and how to manage them (on the MSDS)
• Most risk assessments will be easier to put together and to audit against – Users are required to follow the Risk Management Measures on the MSDS
• The underlying principles of REACH are sound.
BUT…
3
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACH
REACH will 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, and the knock-on R&T and re-formulation costs).
4
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACH
Product lines1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21..
Mar
gin
on
sal
es o
f P
rod
uct
Products are worththe registration costs:
Substances are pre-registered and
then registered.
Cost of registration for the product constituents
Products are NOT worth the registration costs. Substances are pre-registered
and then withdrawn prior to the registration deadline
5
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACH
RISK FACTORS for a substance to be pre-registeredand then not registered:
One of the substances in the preparation is a ‘substance of very high concern’.
Registrant is an SME, or supplies into a market with ‘near perfect competition’ (retail), where there is always very small margins on sales
Registrant just tips into a higher tonnage band, where the cost of registration escalates and the time available reduces
The registrant is an importer (such as a distributor) rather than the manufacturer
The product being imported is a preparation (such as an adhesive) rather than a substance, thereby making the non-EU source less likely to have an only representative for the substance constituents of the preparation.
The product being bought is used in comparatively small markets
6
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Supply chain communication
ChemicalManufacturers
AircraftManufacturer
Importer?Formulator 1
Formulator 2
Distributor 1
Distributor 2
Formulator 3
Metal Basher / base componentFabricator…
ComponentSupplier
Design / Make System Supplier
Major assembly OEM
What is the chance of a U bend blockage ?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACHDECISION POINTS:
1. Look at each of the supply chain scenarios: What would your course of action be to deal with each one within your company?
2. If you lost a substance, preparation or article (it is no longer supplied to you) – Do you care?
8
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!!
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACHACTION POINTS:
1. Inform senior managers about REACH and the risks it poses. Get them to appoint someone to manage it.
2. Identify all your legal entities.
9
3. Hold a workshop inside your company, looking at REACH. How to run the workshop – see the ‘REACH Checklist’ handout
4. Start building a plan to manage REACH (Examples later)
5. Ask your supplier if they (OR THEIR UPSTREAM SUPPLY CHAIN) intend to pre-register AND THEN REGISTER the substances (or the substances within the preparations) that they supply to you.
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACHACTION POINTS:
6. DOCUMENT the responses you get back from suppliers. The answers could be:
• A standard letter back.
• A questioning letter back – recommend some appropriate training!
• Stony Silence. This means you DEFINITELY have a business continuity threat!
10
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACHACTION POINTS:
7. Create an Inventory of all the substances you use
• In preparations in your facilities
• In articles you fabricate yourself
• Start to consider the best way to collect the information for the composition of substances within the articles you buy.
11
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACH
ACTION POINTS:
8. Also for make –to –print suppliers, where YOU are the design authority…
12
1. Ask about the substances and preparations they use to make the parts to your drawings.
2. Your suppliers should also be creating an inventory like the one mentioned in ACTION POINT 7.
3. Have YOU specified the use of something that is going to disappear?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Business Risks and REACHACTION POINTS:
9. Decide on a course of action for each ‘At risk’ substance, preparation or article.
You can:
• Trust your supplier to take care of you
• Try to find other suppliers in the EU who will take care of you
13
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
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
14
©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.
REACH
Doing Pre-registation
15
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Working out what to preregister.
What do you manufacture?
• Do you create reaction products?• Do you take scrap metal from outside the EU
and melt it into new alloys?• Do you take any other waste material from
outside the EU and turn it into a new substance or preparation?
• If the answer is YES to any of these, you are a MANUFACTURER.
16
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Working out what to preregister.
Requirements on manufacturers
• IF you transfer title (‘put on the market’) of the new substance mentioned on the previous slide, in quantities of more than 1 tonne per annum, you must PRE-REGISTER the substance.
• For preparations, the 1 tonne limit applies to each ALLOY CONSTITUENT or constituents of the new preparation, not the whole alloy / preparation.
17
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Working out what to preregister.
What do you import?
• Do you import more than 1 tonne of substances from outside the EU (EU includes Norway and Iceland but not Switzerland)?
• Do you import substances in preparations from outside the EU?
18
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
A B EDAC
ACalculate the total amount of
Working out what to preregister.
19
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
20
Importer or “Only Representative”?
• Only legal entities in the EU can take actions to comply with REACH
• Non-EU companies can Register on their customer’s behalf, but only by using an “Only Representative”
• Only Representative: - “EU-based natural or legal person acting on behalf of a Non EU manufacturer fulfilling the duties of an importer”
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
21
• If your non-EU supplier decides to nominate an “Only Representative” you would no longer have duties as importers but will be regarded as downstream users
• The Only Representative would have the legal responsibility to comply with all relevant obligations under REACH
Importer or “Only Representative”?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Working out what to preregister.
If you import more than a tonne…
• The non-EU supplier is obliged to tell you if they are going to establish an ‘Only representative’ to do the pre-registration for you. Have they contacted someone in your company to tell you that they are going to do this?
• If not, contact the non-EU supplier and ASK!
• If you have not heard from your supplier by the end of the summer, the PRE-Register yourself. Don’t leave it to the last minute!
22
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
23
Pre-registering substances in Articles
Substances in articles require registration when the substance is “intended to be released” and the mass of the substance sold in articles is greater than 1 tonne per annum
• The INTENTION is important !
• The key test is whether the core function of the article is to release a substance. (Examples: a welding rod, packing grease, stop-off)
• A hydraulic cylinder does not have an INTENDED release
• Normal wear is not considered to be an intended release
• Release during disposal is not an intended release
There are still some grey areas
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
24
Intended release?No Yes Maybe
Welding fumes Fragrance from candles Protective coatings intended to be removed before use.
Wearing parts Dyes from clothes Wax coating of components
Combustion products
“Packaging materials for metal parts, releasing grease/ corrosion inhibitors”
Protective oil/grease films?
Welding rods
Stop-off for etching
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
25
The EU is developing guidance on articles - RIP 3.8.
The industry has prepared a document (GLOBAL AEROSPACE AND
defense INDUSTRY OPINION ON WHAT CONSTITUTES A SUBSTANCE,
PREPARATION AND ARTICLE) that provides guidance on:
• PREPARATIONS or SUBSTANCES
• ARTICLES with intended release
• ARTICLES with no intended release
A rationale has been provided for each assumption
This is industry best guidance – but cannot be presumed to be the interpretation that the courts will place on the regulation. When decisions are made in the European Courts, they will supersede this guidance.
Pre-registering substances in Articles
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
26
Substances that were in existence before 1981 should have an EINECS number in the EU numbering system (a bit like CAS). These are the substances that benefit from phase-in.
Substances that were invented post 1981 should have an ELINCS number. These substances should be registered by your supplier already. If the supplier is outside the EU, this may not be the case. If your substance is listed on the ELINCS database you will need to ask your supplier if they have already registered the substance.
The ELINCS and EINECS databases can be seen athttp://ecb.jrc.it/esis/index.php?PGM=ein
If the substance has neither an ELINCS or EINECS number, it will not benefit from phase-in, pre-registration is not necessary: USE is already illegal. You need to stop using it, and make an inquiry to ECHA. See http://echa.europa.eu/reachit/inquiry_en.asp
Pre-registeration or ‘Inquiry’? EINECS or ELINCS?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
27
Before 1981: EINECS number : These are the substances that benefit from phase-in.
Post 1981: ELINCS number: These substances should be registered by your supplier already. If your substance is listed on the ELINCS database you will need to ask your supplier if they have already registered the substance.
The ELINCS and EINECS databases can be seen athttp://ecb.jrc.it/esis/index.php?PGM=ein
Pre-registeration or ‘Inquiry’? EINECS or ELINCS?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
28
If the substance has neither an ELINCS or EINECS number, it will not benefit from phase-in, pre-registration is not necessary:
USE is already illegal.
You need to stop using it, and make an inquiry to ECHA.
See http://echa.europa.eu/reachit/inquiry_en.asp
Pre-registeration or ‘Inquiry’? EINECS or ELINCS?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
HOW to pre-register.
DECISION POINT: Will you do registration yourself, or will you hire a consultant to do it for you?
Benefits Issues
If you make preparationsor articles, registration is
hardly related to your core business. The consultants should be able to represent you, and you can get on withmaking product. They could
take all the paperwork off your hands.
No-one really knows how much registration is going to
cost. The cost of the consultant could spiral, and you could have little control over it. It will require tight oversight. Can you get the
consultant’s contract agreed in time?
29
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
HOW to pre-register.
If you decide to pre-register without the assistance of a consultant…
ACTION POINTS:
1. Familiarise yourself with the Pre-Registration Guidance REACH IT guidance from ECHA. http://echa.europa.eu/reachit_en.asp
2. Before submitting data to ECHA you must sign-up and create an account for your company in REACH-IT via the REACH-IT portal. This is the starting point for any data submission to ECHA. You can find out how to do this at http://echa.europa.eu/reachit/createaccount-it_en.asp
30
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
HOW to pre-register.
3. How may substances do you need to preregister?
• You can pre-register a single substance online via the REACH-IT portal. This is fine for a small number of substances. Pre-registrations can only be submitted via the REACH-IT portal. You can only pre-register one substance at a time with online pre-registration.
• http://echa.europa.eu/reachit/portal_en.asp
• ECHA has created presentations explaining how to do it…
• http://echa.europa.eu/doc/reachit/pres_reach-it_key_conc_en_20080530.pdf
• http://echa.europa.eu/doc/reachit/pres_reach-it_pre_reg_en_20080530.pdf
31
ACTION POINTS:
©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.
REACH
Doing Registration:Registration if you are aManufacturer / Importer
33
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
34
Doing Registration
Manufacturers / Importers of substances into the EU have to register them with the European Chemicals Agency (ECHA)
• Registration will involve identification of all USES of a particular substance (such as use as a paint thinner, in an alloy etc) and supporting information
• Failure to register USES of a material by predetermined deadlines can interrupt the supply of that material
“No data, no market”
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
35
Estimated Registration cost for one SubstanceVolume tier Individual
registration (Euro)1
Average testing cost cost substance (Euro)2
1 - 10 tonnes 1,600 56,360
10 - 100 tonnes 4,300 279,838
100 - 1000 tonnes 11,500 799,562
> 1000 tonnes 31,000 1,582,616
1Draft Regulation on Fees and Charges, Individual Submission under Article 6, 7, or 11, October 2007, p. 16.2 Source: Fleischer, M.,”Testing Costs Testing Capacity According to REACH Requirements – Results of a Survey of Independent and Corporate GLP Laboratories in the EU and Switzerland,” September 2007, pgs. 96-114
Some suppliers may look at these costs and decide that the cost of REACH compliance is not worth it and terminate some products
Doing Registration
35
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
36
DRAFT April 25, 2008
Suppliers/importers need information to write chemical safety reports and identify ‘Exposure Scenarios’, including:
• Epidemiological studies, animal testing
• Typical uses and exposure data
EU manufacturers and importers must form “Substance Information Exchange Fora” (SIEFs) who must minimize testing.
Doing Registration
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
37
ACTION POINTS:
1. If you have determined that you are a manufacturer or importer and you are going to pre-register, you need to seriously examine your ability to participate in the SIEF.
Do you have the right subject matter experts to participate in the debates on animal testing, toxicology, carcinogenicity?
Do you know what tests are relevant to all your and your downstream user’s uses are?
Seriously think about employing expert assistance.
Doing Registration
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
38
SIEFS and CONSORTIA
• The larger companies will probably form consortia, to carry out the animal testing that relates to the majority of their uses.
• Where the uses that you need to register overlap, you will need to buy the relevant data from the consortia as part of the SIEF.
• If the main consortia decides not to deal with the tests that you need, you may have to develop your own mini-consortia in the SIEF with others who need the same information.
Doing Registration
©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.
REACH
Downstream users – Managing the risksFrom Registration.
40
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Supply chain communication
41
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Supply chain communication
ChemicalManufacturers
AircraftManufacturer
Formulator 1
Formulator 2
Distributor 1
Distributor 2
Formulator 3
Metal Basher / base componentFabricator…
ComponentSupplier
Design / Make System Supplier
Major assembly OEM
US
ES
IN
FO
RM
AT
ION
MS
DS
and
Risk
Man
agem
ent M
easures
Info
rmatio
n
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
EACH Registrant, will make sure all of their own uses, and all of the main
downstream uses in their supply chain, are registered.
They WILL do this for the obvious uses:
• Trichloroethylene as a degreaser.
• Toluene and Xylene in paints.
• Epoxy resin in adhesives.
They WILL NOT do this for the less obvious uses
• The aerospace and defence sectors WILL have weird uses.
If your use is not covered in the registration, it will be ILLEGAL.
Doing Registration as a Downstream User
43
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Uses not on the MSDS
This occurs when…Outside the conditions described in the “exposure scenario”, Not covered by the “exposure scenario”
Exposure scenario: The way in which a person, or the environment, gets exposed to the substance. Such as: Inhalation, Ingestion, Into water courses, Into soil.
How will they decide the Exposure Scenarios they will cover?It depends on the likely routes. Substances in kettle heating
elements could be ingested. Substances in paint could get into the body via inhalation, via dermal contact, and can get into water courses, and possibly into soil (when landfilled)
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Uses not on the MSDS
Options:
• Inform supplier: they then can create / modify exposure scenario for your use
• Change your conditions of use to those on the MSDS
• find another supplier that is covering your conditions of use,
• prepare a DU chemical safety report yourself
• find an alternative substance, preparation or process and stop using the substance/preparation in question.
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Taken from http://reach.jrc.it/docs/guidance_document/information_requirements_r12_en.pdf
What defines a “Use”?
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
ACTION POINT:
If the Manufacturer / Importer does not include your use on the
MSDS, you can write your own Downstream Users’ Chemical
Safety Report in order to ensure continued supply.
Doing Registration as a Downstream User
49
See the section on Downstream User Chemical Safety Reports
in the Downstream User guidelines
http://reach.jrc.it/docs/guidance_document/du_en.htm
©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.
REACH
Needing and getting anAuthorisation
50
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
“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, persistent organic pollutants, ozone depleting substances)
51
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Needing and getting anAuthorisation
• Substances of very high concern will be identified and eventually be PHASED OUT.
• Some substances will simply be banned – this is the RESTRICTION process.
• Some substance cannot simply be banned
• they are used too widely,
• there are no ‘drop-in’ replacements.
• These substances will go through the AUTHORISATION process.
52
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Substances used in Products and Processes
Substances that meet the SVHC criteria
All substances
Candidate List
AnnexeXIV
53
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Needing and getting anAuthorisation
ACTION POINTS:
1. For these substances most likely to be on the candidate list,
identify ALL your uses of these substances
• In your product
• In your process chemicals
• In any quantity
• Whether there by accident or by design.
There could be other substances you need to be
concerned about – we talk about this later.54
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Needing and getting anAuthorisation
ACTION POINTS:
2. For each use of each substance, collect together any / all
occupational hygiene, health surveillance, toxicological data
and claims data you have.
3. Are any of these uses or candidate list substances, “substances of
strategic importance” to your business?
• Is there a safer alternative you can use instead? (regardless of
cost!)
• Will changing to the alternative be cost-prohibitive to your business
(watch your margins!)
• How long will it take your business to adapt to life without
the substance?
55
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Needing and getting anAuthorisation
ACTION POINTS:
4. Is it worth collaborating with other companies in your sector?
5. Does the substance have a threshold value, below which it is
considered ‘safe’?
• With a Threshold: you can prove you are using it safely, and
write a substitution plan to develop and use alternatives
• Without a Threshold: you need to prove using a ‘Socio-
Economic Analysis’ that it is essential to be able to continue to
use the substance.
56
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Needing and getting anAuthorisation
ACTION POINTS:
6. Writing a Socio-Economic Analysis:
• Comparing the benefit of no longer using the substance on the
workforce, within the locality, and across the substance life cycle
in comparison to the societal and economic benefits from
continued access to it.
Arguments could include…
• Adverse effect on other significant environmental impacts by changing
• Adverse effect on employment and economic prosperity in the EU at specific locations, regionally and nationally.
• The risk will just be shifted to outside the EU. 57
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
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
• The list is issued as part of the technical reports TR 9535 and TR9536. These are written as standards which can be used in contracts to provide the first iteration of a data exchange format between actors in a supply chain.
http://www.asd-stan.org
TR 9535 and TR 9536
The Declarable Substances list
58
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Substances in our Products and Processes
Substances that meet the SVHC criteriaDeclarable Substances
SAE and ASD-STAN standard 9535 / 9536
All substances
Candidate List
AnnexeXIV
Relevant to YOUR business
59
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
The Declarable Substances list
A 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 Protocol
• Persistent Organic Pollutants as defined by the Stockholm Convention, etc.
• Substances listed within Annex XVII (restricted substances)
60
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
ACTIONS for everyone
ACTION POINTS
1. 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 function?
• Tighten up these processes!
61
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
The Declarable Substances list
ACTION POINTS: How can you use this list?
2. Go through all your MSDS’s for your facilities, and see which of the
substances on the declarable substances list you are using. There are
probably around 5 per site.
3. Repeat the exercise for MSDSs with material specifications and with
the non-metallic substances used to make your products.
4. If you assemble products, the component articles you buy may contain
SVHCs. You can either:
• Create a check list and ask your suppliers to confirm that none of the
substances on the list are within the product they supply
• Apply TR 9535 and TR 9536 in contracts. This will tell you
if there are SVHCs within the product.62
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
The Declarable Substances list
ACTION POINTS: How can you use this list?
5. If you find a substance on the declarable substances list in
an MSDS, in a material spec or in a component you can:
• See if there is something safer out there
• See if the supplier is likely to reformulate the preparation
• See if it is a strategically important substance, which is a significant
risk to your business.
6. Create a business continuity plan for each of the
substances in each of the tradenames / specs /
articles that is strategically important to you.63
©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.
REACH
What to do when you use a Substance that is being Restricted:
Dealing with Restriction
64
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Restriction vs Authorisation
• Authorisation can only apply to substances on their own or in preparations, before being incorporated into Articles.
• Article imports that contain a candidate list substance are not regulated under Authorisation. But can be banned from being imported via Restriction.
65
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
• This will be need to be dealt with in your companies in the same way as you dealt with asbestos removal, checking there is no nonylphenol in detergents, checking there is no pentabrominated diphenyl in your non-metallics etc.
• Very little will change from the way that substances have historically been restricted in the EU.
Dealing with Restriction
66
©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.
REACH
The requirement to declare Candidate List ‘Substances of
Very High Concern’ to your customer, their customers, and in some cases, to
ECHA: Making declarations
67
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
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
68
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Articles
Registration = if intended release
Notification = if ‘Candidate List’ & >0.1% w/w & cannot excluded exposure
unless already registered for that use
69
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Making Declarations:Declaring to the Customer
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.
70
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Making Declarations: Notification of ECHA
You 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 customer71
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Making Declarations: Information flow
Exam Question:What is the percentage of the SVHC a) In the component sold as a spare and b) in the article?
Substance of Very High Concern
Candidate List (ECHA Website)
Incorporated into a Preparation
Incorporated into a Component
Incorporated into an Article
And sold as a spare part
72
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Substances in our Products and Processes
Substances that meet the SVHC criteriaDeclarable Substances
SAE and ASD-STAN standard 9535 / 9536
All substances
Candidate List
AnnexeXIV
Relevant to YOUR business
76
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
REACH and the need for IT
• How will you collect the ‘bill of substance’ information for the articles you make?
• ERP systems? PDM / PLM systems? Other systems?
• How will you extract the information from the supply chain about the SVHCs in the articles you supply?
• Supplier portal? Use the standard information exchange format? Where will you store the data? How will you process the data? 77
COLLECTING THE DATA REQUIRED FOR REACH FOR THE ARTICLES YOU MAKE IS PROBABLY GOING TO NEED NEW OR MODIFIED IT.
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
REACH and the need for IT:
• Develop an IT strategy for dealing with Declaration
• Get an agreed policy for the declaration of substances in the articles you buy across stakeholders in your legal entities.
• Implement contractual clauses to enable you to get the information you need from suppliers, as inputs to your IT
• Create and issue a business requirements document for the IT to support declaration
• Agree the concept design
• Agree the detailed design
• Go live on the IT
78
ACTION POINTS:Set up a REACH IT business project to enable you to get the IT you need to store and manage REACH related data.
©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.
REACH
REACH Programme Management
79
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Actions for Everyone:
• Who…Purchasing? HSE? Materials? Design?
• Where is the BIGGEST risk to your business – let the most affected department lead on it.
• Plan out how you will hit the pre-registration deadlines (30 November 2008) and then the later deadlines.
• Write Communication Plans for the supply chain and your own people.
• What are your legal entities…each one has a separate legal obligation!
• Will your internal processes and procedures need changing?
80
ACTION POINT:Appoint someone (full time if you can!) to manage REACH as a project inside your company
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Actions for Everyone: PlanningStep Milestones for Activities
1 All level 3 plans (site level) rolled out and governance in place
2 a) Pre-Registration completeb) Registration complete
3 a) Inventory of all preparations used and their manufacturing use codeb) Inform our suppliers of preparations of our usesc) Continuity plans for all key preparations with substances on the Declarable
Substance List 4 Authorisation - awaiting clarification of legislation
5 Agreed concept for all businesses to comply with Declaration (art. 33)
6 a) Continuity plans for all substances in Articles which are also on the Declarable Substance List
b) Receive first candidate listc) Continuity plans for all substances in Articles which are also on the
Candidate List 7 Communication completed to all internally affected areas
8 New Quality Procedures issued and implemented
Rolls-Royce data – If you circulate please credit the company. Information is given in good faith.
Actions for Everyone: PlanningREACH Milestone Chart Legal Entity :
V2 Plan Owner :
Status StatusApr May
REACH Programmeplan
actual
plan
actual
plan
actual
plan
actual
Pre-Registration and Registrationplan
actual
plan
actual
plan
actual
plan
actual
plan
actual
Business Risk from Preparationsplan
actual
plan
actual
plan
actual
plan
actual
plan
actual
plan
11.2 Define scope of legal entity
1.1
Governance of Actions REACH PM
POC
POC
Activities SupportLead
2.1 Determine any Articles with intended release
2008
Define Point of Contact for legal entity Exec Team
1.4
Hold initial workshop Exec Team
REACH Exec
Determine how it will be preregistered (self, own rep etc) Procurement
Determine what needs to be pre-registered (incl. analysis of imports) Procurement
Complete registration As requiredSubstance Owner
Categorise the manufacturing use of each preparation (as defined by RIP3.2.2) Local HSE
Collate inventory of Substances and Preparations used in RR facility to manufacture product
Local Lab
Procurement
Local HSE
Local Lab
2.4 Complete Pre - registration POC
2
3
Step and Status
Local lab
Risk Analysis of preparation suppliers and mitigation actions Procurement
Analyse the Safety Data Sheets for substances also on the DSL Local HSE Corp HSE
Corp HSE
POC
Engineering
POC
POC
Inform suppliers of our uses and request that this use will be registered
Contiunuity plans for substances in Safety Data Sheets and in DSL Substance Owners
Last Updated :
3.5
3.6
1.3
3.3
3.1
2.2
3.4
2.3
3.2
2.5
©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.
REACH
QUESTIONS
85