Presentation for GBSO Networking Meeting

REACH Regulation:

Implications for businesses and the network

• General introduction to REACH

• Provisions

• Exemptions and obligations

• Timelines

• Preparing for REACH

Agenda

The Regulation

[REACH will enter into force on 01 June 2007]

REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT

AND OF THE COUNCIL

of 18 December 2006

concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European

Chemicals Agency, amending ………...

REACH will replace existing Regulations and Directives

Classification and labelling of dangerous substances (67/548/EEC)

Classification and labelling of dangerous preparations (88/379/EEC; 1999/45/EC)

Evaluation and control of the risks of existing substances (793/93/EEC)

Restrictions on the marketing and use of certain dangerous substances and preparations (79/769/EEC)

General provisions

• Applies to the manufacture, import and placing on the market of substances on their own, in preparations or articles

• Exemptions are listed

• Tonnage and hazard-based criteria determine actions

• Phase-in substances• listed in EINECS

• manufactured in EU but not on market 15 years before eif

• placed on EU market before eif and notified under 67/548 and a no- longer polymer

General provisions

RegistrationPre-registration for phase-in (older) substances, data sharing (SIEFs),technical dossier to submit on properties, uses etc.

EvaluationAgency evaluates proposals for testing and compliance with requirementsAgency may request further data

AuthorisationSubstances of high concern (CMR, PBT, vPvB, others)Registrants demonstrate acceptable risksSocio-economic benefits reviewed

RestrictionsProcedure to regulate based on conditions for manufacture or use

Excluded from REACH

• radioactive substances

• substances subject to customs supervision

• non-isolated intermediates

• carriage of dangerous substances by rail, road, inland waterway, sea or air

• waste

• defence-related substances (Member State discretion)

Exemptions from some but not all provisions

• substances used for human or veterinary uses (medicines)

• substances in feed or foodstuffs (additives, flavourings)

• Annex IV and V substances

• polymers

• on-site intermediates

• cosmetic products

• medical devices

• active substances in plant protection and biocidal products (considered registered)

Pre-registration dossier for phase-in substances

Recall: phase-ins are those substances listed in EINECS, no-longer polymers on EU market (and notified under 67/548)

• Pre-registration dossier

•identity of substance (name, EINECS, CAS number etc.)

•name, address of contact person

•envisaged deadline for registration

• CMR > 1 t/p.a.; N, R50/53 > 100 t/p.a.

Registration dossier requirements

Basics (rarely will this be done in isolation):• Identity of substance and manufacturer

• Info on manufacturing and use

• Classification and labelling

• Guidance on safe use

• Study summaries

• Test proposals

• Exposure information

Registration dossier

Contains:

A technical dossier, and

A chemical safety report (CSR), if triggered

Chemical Safety Report

Triggered at > 10 t/p.a.

• Hazard assessment

• Human health

• Environment

• Physico-chemistry

• PBT/vPvB

• If substance is classified or is a SVHC

• Exposure assessment

• Risk assessment

• Risk reduction/management measures

Substances in articles

Articles

• Registration required if substances in article:

• > 1 tonne/p.a.

• Intended to be released

• Notification required if substances is CMR, PBT, vPvB or ‘other concern’ and:

• > 1 tonne/p.a.

• Present > 0.1% (w/w) [entire article]

• Deadlines same as for substances

• Notification Dec 2011 earliest

Articles (cont.)

• Exemptions from registration and notification

• if the substance in the article has already been registered ‘for that use’ by anyone

• Other applicable exemptions as for substances

• Exemption from notifying a SVHC if notifier can exclude exposure of substance to humans or environment during normal or reasonably forseeable conditions of use [includes disposal]

Articles and information in supply chain

• Suppliers of articles containing SVHC must provide sufficient information allowing safe use of article, including name of substance(s)

• to recipients of articles

• to consumers

• Such information must be supplied within 45 days of receipt of request

Downstream users (DU)

Downstream User (DU)

• Any industrial or professional user of a substance - formulator - industrial user in production - manufacturer of articles

• Not DU - distributor, retailers, consumers

DU obligations, tasks

• Importer? – check

• Must implement operational conditions and risk management measures communicated to him via exposure scenarios in the SDS Annex

• If you receive SDSs?

• No = limited obligations

• Yes - next slide

• Probably greatest challenge is to identify composition of articles

Obligation to communicate and report

• Communicate up the supply chain

• info on hazardous properties

• uses (secure supply, get SDS/ES to cover uses)

• Communicate measures to control risks to customers

• Report to Agency (not if < 1 tonne/yr)

• in case DU CSA is required

• if classification differs from suppliers

• Keep CSR available and up to date

SVHCs

Definition of a SVHC

• Cat 1 and 2 carcinogens

• Cat 1 and 2 mutagens

• Cat 1 and 2 reproductive toxicants

• Persistent, bioaccumulative, toxic substances (PBTs)

• Very persistent, very bioaccumulative (vPvBs)

• Substances with equivalent concerns

• e.g. potential endocrine disruptors

SVHCs will be

• Identified (major issue – see lists)

• Listed on Annex XIV

• Subject to authorisation (a bad thing)

• Small volume SVHCs may be placed on Annex XIV and uses authorised

Classification and labelling

C & L under REACH

• C & L rules of 67/548 and 1999/45 remain

• continue to classify and label according to existing law, but safety data sheet to include PBT, vPvB information

• Obligations

• C&L submitted as part of registration dossier (need to agree amongst other notifiers)

• 3 years from eif (groups of) manufacturers to report C&L to Agency – goes into the inventory

• Future: GHS

• Commission legislative proposal, consultation completed

• GHS to replace 67/548 and 1999/45, mid-2008

• Dual application of C&L for 3-4 year period

Next steps for phase-ins

After pre-registration (1)

• By January 09, Agency to publish list of pre-registered substances on its website (no company names)

• Around the same time, Agency is expected to inform all pre-registrants of the same substance of the identity of the other companies (by email?)

• All pre-registrants become members of substance-specific SIEF automatically (upon pre-registration)

After pre-registration (2)

• Upon publication of list of pre-registered substances on Agency’s website, other parties may become members of SIEF

• companies manufacturing/importing below 1 t/p.a.

• downstream users

• third parties holding information on substances

• non-EU companies not active in the EU, NGOs?

After pre-registration (3)

• Upon publication of list of pre-registered substances on Agency’s website downstream users, of substances not appearing on the list, may notify the agency

• Agency expected to act as a match-maker

Aims and function of SIEF

• Facilitate exchange of information and avoid duplication of studies

• Agree classification and labeling of substance

• SIEF operational until at least June 2018

• In practice companies expected to start discussions before pre-registration

• Lead registrant?

• initiate discussions, propose consultants, propose agreements;

• but manpower is costly

Timetable

EIF Pre-registrationJune to December 2008

Registration>1000 tonne/paCMRs > 1 t/paR50/53 > 100 t/pa

December 2010

Registration100 - 1000 t/pa

June 2013

Registration> 1t/pa

June 2018

SIEF, data sharing, consortia, CSA, CSR

Report C&L to Agency*

Preparing for REACH

Preparing for REACH

• Obtain an overview of which REACH obligations apply to your company

• Take strategic decisions about substances, products, suppliers and customers to be ready for (pre)registration and registration

• Inventory and assessment of substance properties – 2 stage process

First step - inventory

• Develop company INVENTORY of all substances, (preparations, articles), produced / imported, used or sold by company

• this includes establishing the composition of articles and preparations

• Note: INVENTORY has to be at legal entity level and should be centralized at group level

• Commercial products available to manage REACH, incl. Inventories [eg. Baytouch Ltd.]

Inventory

• Substance identification

• Tonnage (in preparation or article)

• Concentration of substance in article and article compositions

• Exemptions, precise uses

• Suppliers, customers (continued supply)

• suppliers in EU, CBI issues

• Limited information on CMR and N, R50/53

Second step - assess substances/decisions

• Filter out those substances not in scope

• Establish available data

• Classification and whether a SVHC

• Assess possible authorisation, restrictions

• Stop using/producing/importing/supplying?

• Change customers or suppliers?

• Early preparation for SIEFs

Third step - other planning

• REACH organization (internal structure and budget)

• Review of contracts

• current example in aerospace industry

• REACH record keeping system Article 35

• Training

Commission activities

REACH implementation projects (RIPs)establish new agencyprepare I.T. for new agencyprepare technical guidance for industry and MSs flowchartsSIEFs

Strategic partnerships (stakeholders practising)SPORT (2004) covering 50 substances (simulate registration)PRODUCE (downstream user obligations, communications)

For further information :

Louis Wyness Regulatory ConsultantTel +44 (0) 1423 799 151E-mail Louis.wyness@tsgeurope.com

Matt Curl Regulatory ConsultantTel +44 (0) 1423 799 158E-mail Matthew.curl@tsgeurope.com

Vicky Atkinson Sales and Marketing+44 (0) 1423 799 172Vicky.atkinson@tsgeurope.com