EU Regulation 1907/2006

on the Registration Evaluation and Authorisation of CHemicals

REACH Lunch & LearnBeach Ballroom, Aberdeen29th August 2007

REA CH

Outline

• What is REACH?

• What are the implications?

• REACH timetable

• Chemical usage

• How does it effect us?

• REACH for suppliers (Huw Jones, Nalco)

• BMT Cordah & REACH

REACHRegistration, Evaluation and Authorisation of Chemicals

“The biggest shake-up in chemical legislation in 30 years”

“REACH replaces 40 existing legal acts and creates a single system for the assessment of all chemical substances”

Why new legislation?

• Over 30,000 substances on the EU market above 1 tonne per year

• Very limited information available on hazards and risks

• Current system very slow – 200 substances fully assessed in 20 years

Implications of REACH• Substances may be withdrawn

Chemical Industry estimate 40% of chemicals on the EU market could be withdrawn.

• No registration – no market

Failure to register a substance means that the supplier cannot market the substance until it has been registered.

• Downstream Users (DU) have specific obligations

DU must support risk assessment process.Estimated cost to all DU of chemicals €2.8 – 5.2 billion.

So What Does That Mean

• Will lead to product rationalisation (biocide example)

• Product costs from suppliers are likely to increase by on average 10%

• Suppliers may deal direct with customers reducing many distributor SMEs to agents

• LOSS not gain of intellectual development

MELVYN WHYTEMD WHYTE CHEMICALS LIMITED

9

Slide taken from Chemical Business Association conference, January 2006

REACH Timetable

Set-upAgency

>1000 t>100 t N:R50-53> 1 t CMR

100 –1000 t

10 –100 t

1 –10 t

Pre-reg.

June2007

June2008

Nov.2008

Nov.2010

June2013

June2018

REACH Registration Deadlines

Chemical Usage

• Currently proposed chemical usage is notified through the PON system.

• Risk assessments are performed (generally on a PEC/PNEC basis) for the worst case component (WCC) only, using CHARM.

• REACH will require assessment of all components.

• Exposure modelling and risk assessment is required for all component substances

• DU may choose to perform their own exposure modelling

• Different timescales for registration based on annual tonnage and PBT properties

Downstream Users (DUs)

Draft Guidance – RIP 3.5.1 Annex 3

http://ecb.jrc.it/documents/REACH/

A DU is defined by REACH as someone, other than a manufacturer or importer,

“who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities”.

The guidance identifies a number of types of DUs, Industrial User 1 (IU1):

“actor using substances/preparations not incorporatedinto articles (in a preparatory process or as a processing aid)”

DU - Obligations

• Determine whether your use is included in the exposure scenarios in safety data sheet (SDS)

• If use not covered, will supplier include use or undertake own assessment (Chemical Safety Report, CSR)

• Apply operational conditions and risk management measures detailed in SDS

• Keep CSRs up to date

• Comply with any restrictions on use of substance/preparation

• Use authorised substances only within conditions of authorisation

DU - Communication

• Provide information to assist supplier in the preparation of registration

• Have the right to make use known to supplier for inclusion as an identified use

• Must provide information where risk management measures are inappropriate

• Inform supplier of any new information on hazardous properties of substance/preparation

• If you supply substances/preparations to further DUs you have further obligations

Operator’s Chemical Usage Facility A Facility B

Chemical 1 608 25         633

Chemical 2 130 359       489

 

 

         

Specific Chemical Details

Chemical 1

WCC - 30-60% (285 T)

ESIS data suggests there may be data availability issues?

Quantities in tonnes

How does REACH effect us?

• Must make inventory of substances

• Must gain assurance that suppliers will meet REACH obligations (Reg. & RA)

• Gap analysis of data

• Implement REACH Strategy

• Suppliers must prepare and submit registration

• Check your use is covered, consider own exposure model

• 11 year phase-in period to harmonise OCNS (PON15s)

Set-upAgency

>1000 t>100 t N:R50-53> 1 t CMR

100 –1000 t

10 –100 t

1 –10 t

Pre-reg.

June2007

June2008

Nov.2008

Nov.2010

June2013

June2018

REACH Registration Deadlines

REACH from a Supplier’s point of view

Huw JonesREACH Programme ManagerNalco

BMT Cordah & REACH• Experienced and trained staff in the field of REACH

• Guide operators in producing a REACH strategy and assessing supplier commitment to product registration

• Highlight and address chemicals that are at risk of not being registered

• Assistance with risk assessment & exposure modelling if required

• Consortia management for chemical suppliers

• BMT Cordah act as Only Representative

• BMT Cordah committed to staying on top of changes to risk assessment process and the harmonisation of OCNS with REACH

Thank you