Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations REACH

©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 data – strictly private

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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Pre-registration


Registration



Evaluation


Authorisation


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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Pre-registration


Registration



Evaluation


Authorisation


Restriction


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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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Pre-registration


Registration



Evaluation


Authorisation


Restriction

Declaring Substances of Very High Concern in Articles to customers


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!


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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.


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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]

Documents

Registration, Evaluation, Authorisation and Restriction of Chemicals Regulations REACH