Future legislation on chemicals and REACH processes

Jens Tørsløv

European Chemicals BureauInstitute for Health and Consumer Protection

Joint Research Centre

Contents

• Why a new Chemicals Policy?

• Main elements of REACH

• REACH main changes

Why a new Chemicals Policy?

Implementation of RMMs in Community legislation

General Risk Assessment / Risk Management process

Identificationof risk

management measures

Risk Assessment

Data Generation

Identification of ‘priority’ substances

Legislative context

Technical Guidance Documents (1996)Technical Guidance Documents (1996)

Directive 92/32/EC Regulation (EC)793/93

Directive 93/67/EC Regulation (EC)1488/94

Directive 92/32/EC Regulation (EC)793/93

Directive 93/67/EC Regulation (EC)1488/94

New substances Existing substances

1993 1994

Directive

98/8/EC

Directive

98/8/EC

Biocides

Technical Guidance Documents (2003) Technical Guidance Documents (2003)

2003

2002

Principles for risk assessment

Detailed procedures for risk assessment are given in the Technical Guidance Documents (TGD):

manenvironmentQSARsemission scenario

documents

Freely available from the ECB web page

http://ecb.jrc.it/tgdoc

PEC/PNEC

Emission rates

Distribution

PEC

Data set

Single speciestoxicity data

Extrapolation

PNEC

Exposure assessment Effects assessment

Risk characterization

Data evaluation

Basic Framework of Risk Assessment Process

TGD

EUSES

Main successes of current legislation

• Large data gathering and summarising process for HPVCs

• Agreement on RA principles (TGD/EUSES)• Agreement on priority setting (HERO)• EU harmonised risk assessments for many

controversial substances, forming the solid basis for EU wide risk reduction measures

Main Problems

• Data gaps: 86% of HPVCs have less than base set data

• The process takes (far) too much time• Burden of proof is on public authorities• Generally Downstream Users stay out of the

picture, actual uses of chemicals remain unknown• The system is inefficient: Industry is faced with a

myriad of directives and regulations • Administrative burden for new, mostly low volume,

chemicals prevents innovation

REACH

Registration,

Evaluation and

Authorisation of

CHemicals

REACH objective

• Sustainable Development– Protection of human health and the environment– Maintain/enhance innovation/competitiveness– Maintain the Internal Market– Increased transparency and consumer

awareness– Integration with international efforts– Promotion of non-animal testing– Conformity to WTO obligations

REACH principle

• Industry ensures manufacturing, placing on the market and use do not adversely affect human health or the environment

– Manufacturers and importers assess and document that risks are adequately controlled

– Manufacturers and importers communicate to downstream users how to control risks

– Downstream users apply measures to control risks and communicate this further downstream

The EU accounts for 33% of the World Chemicals Sales

The EU chemical industry comprises 27 000 enterprises96% SME; 30% of sales; 37% of employment (1.3 million).

Scope:• all other substances of high

concern following risk assessment

Scope: • manufacturers, importers,

professional users• substances, in preparations, in

certain articles• mandatory data tonnage

dependent• Chemical safety report• Safety data sheet

Main elements of REACH

Registration of all substances Registration of all substances > 1 t/yr> 1 t/yr

Evaluation by Evaluation by competent authoritiescompetent authorities

Authorisation of certainAuthorisation of certainhazardous substanceshazardous substances

Measures for Measures for substances of concernsubstances of concern

Scope: •carcinogenic, mutagenic, reprotoxic substances (CMR-substances)•Endocrine disruptors•Persistent bioaccumulating toxic substances (PBTs or vPvBs)

Scope: •decisions for additional information•proposal for authorisation•proposal for restriction measures

REACH: KEY ELEMENTS

• Introduces a Single Coherent System for new (non phase-in) and existing (phase-in) substances

• Key elements:– Registration by industry of manufactured/imported chemical

substances > 1 tonne/year (staggered dead-lines over 11years)

– Increased information and communication throughout the supply chain

– Evaluation of some registered substances (Agency and Member States)

– Authorisation only for use of substances of very high concern – Restrictions: “Safety net” (Community wide action)– Chemicals Agency to efficiently manage the system

Focus on priorities:• High volumes (chemicals with greatest likely exposure register first)• Greatest concern (Carcinogenic, Mutagenic and Reprotoxic register first)

REACH - Registration

Manufacturers and importers obtain information on their substances and

use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle

Documentation: Electronic Registration dossier submitted to Agency

Certain non-confidential information to central (largely public) database

No formal acceptance - industry retain responsibility

AIM: Ensure industry adequately manages risks from substances

REACH - Registration

Scope– Substances 1 tonne/year per

manufacturer/importer (M/I)– Exemptions: Some other law, Annex IV/V;

polymers (review); R&D (PPORD)– Intermediates: Exempted or reduced requirements– Considered as registered: biocides, pesticides,

notified/ELINCS substances (but only for the one who has notified !)

• Consortia encouraged

No formal acceptance - industry retain responsibility

AIM: Ensure industry adequately manages risks from substances

Provide confidence that industry is meeting obligations

Prevent unnecessary testing

REACH – Evaluation(by Agency and Member States)

Dossier evaluation Substance evaluation

Check test proposals Compliance

Output:• Further information decisions• Info to other parts of REACH/other legislation

Examine any information on a substance

Ensure risks from substances of very high concern are properly controlled or that the substances are substituted.

REACH - Authorisation

• Applies to– CMR, PBT, vPvB, ‘equivalent concern’ *– Substance, substance in preparation (unless below

concentration limit), substance incorporated into an article.

• Prioritised - Substances are progressively authorised (as resources allow)

• Substance cannot be used unless it is authorised• Authorisation applicant (industry) to show:

– adequate control of risks, or– social and economic benefits outweigh the risks and no suitable

alternatives• Commission decision based on Agency opinion

* CMR: Carcinogenic, Mutagenic or toxic to Reproduction* PBT: Persistent, Bio-accumulative and Toxic* vPvB: very Persistent and very Bio-accumulative

Safety net

REA(R)CH - Restrictions

• Community wide concern• Members States or Commission initiated• Agency Committees examine:

– the risks, and– the socio-economic aspects involved

• Commission - final decision• Carry-over of existing restrictions

(76/769/EEC on marketing and use).

European Chemicals Agency

• Day to day management of REACH– Technical, scientific and administrative aspects

• Responsibilities:– Registration - reject or require completion of registration– Evaluation – main tasks in conduct; priority setting;

coordination and harmonisation– Authorisation/restrictions - facilitate process; suggest priorities.– Secretariat for Forum and Committees– Deal with appeals - registration, R&D, evaluation,

confidentiality

• Location: Helsinki, Finland • Fully operational: Entry into force + 12 months (2008)

REACH main changes

• One regulation replaces a number of legal acts on new/existing chemicals

• Burden of proof for safe use shifted from authorities to industry

• No registration – no manufacture or import• Registration for all substances manufactured or

imported > 1 tonnes/yr• Chemical Safety Report for all substance

substances manufactured or imported > 10 tonnes/yr

REACH main changes

• Agency do not approve industry registration and chemicals safety report

• Authorities evaluate selected dossiers for compliance with REACH

• Authorities evaluate selected substances based on a priority setting

• MS authorities are responsible for enforcement

REACH main changes

• Communication in supply chain play an important role in preparing registrations

• More precise information to the user on how to use substances/ preparations

• Increase awareness among downstream users

New roles for the actors

New roles for the actors

Main processes (actor underlined)

• Registration

• Downstream users

• Authorisation

• How to demonstrate safe use of chemical- Registration dossier- Information requirements- Chemical Safety Report- Exposure Scenarios -> Extended Safety Data

Sheets

Registration

Registration

AIM:

Manufacturers and importers obtain information on their substances and

use this knowledge to ensure responsible and well-informed management of the risks these substances may present throughout their life cycle

Registration Dossier = Documentation

Technical Dossier: starting at 1 tonnes per yearChemical Safety Report: starting at 10 tonnes/year

No formal acceptance - industry retain responsibility

4.6004.600 10 - 100 t 10 - 100 t

20.00020.000

1 - 10 t1 - 10 t

Testing, Safety Assessment, RegistrationTesting, Safety Assessment, Registration

Registration

2.9002.900100 - 1000 t100 - 1000 t

ProposalProposal AdoptionAdoptionPre-Pre-

registraregistrationtion

Consortia Consortia formationformation

registrationregistration

2000 201920142003 20102007 2008

Consortia formationConsortia formationregistrationregistration

Consortia formationConsortia formationregistrationregistration

2.6002.600 1000 t + CMR ... 1000 t + CMR ...

+ 3 yr + 6 yr + 11 yrStart

+ 18 m

Fully in force + 12 m

phase-in substancesphase-in substances

No of substances No of substances

What is a pre-registration ?

• Submission within 18 months of entry into force of a simple pre-registration dossier to the Agency:

– Substance identity– Name and address of registrant– Expected dead-line for registration (tonnage

dependant)– Other information (art 28(1)(d)

• Substances not pre-registered have to be registered before marketing (similar to non-phase in)

Registration: Information requirements

• Data on physicochemical and toxic properties• The higher the tonnage, the higher the standard

information requirements (REACH Annex VII-X)• NB! All available data must be collected

regardless of tonnage (REACH Annex VI – step 1)

Animal testing and data sharing

• REACH aims to reduce the need for animal testing:– Annex XI provides for adaptation of standard data

• Testing not technically possible• Exposure-driven testing• Alternative methods (QSAR/in vitro/grouping/read-

across)

– Testing proposal when vertebrate testing is needed – Substance Information Exchange Fora (SIEF) for

the same pre-registered substances– ‘Mandatory’ sharing of vertebrate animal data

Testing only when necessary

EndpointInformation:

Annexes VII-XI

(Q)SARs

Read Across

In-vitro

Waiving:• technical• exposure

Existinginformation

TESTING

Last resort

Legal access to data on inherent properties

• The registrant must have legal access to the study reports for data used for a registration

• Cost sharing to be agreed in the Substance Information Exchange For a (SIEF)

• NB! Mandatory sharing of vertebrate animal data

What is the Chemical Safety Report (CSR) ?

• The CSR is the documentation of the Chemical Safety Assessment covering:– Hazard Assessment of the inherent properties;

physicochemical and toxic properties– PBT and vPvB assessment*

• and when substance is dangerous or PBT/vPvB– Exposure Assessment quantifying human and environmental

exposure levels– Risk Characterisation– Development of Exposure Scenarios

Substance to be registered

> 10 tonne/year

Technical Dossier•Identity of substance•Manufacture and use•Classification and labelling•Guidance on safe use•Study summaries•Test proposals (if relevant)•Exposure information

Chemical Safety Report•Hazard and PBT AssessmentAlso

Chemical Safety Report•Hazard and PBT Assessment•Exposure Assessment•Risk Characterisation AND•Exposure ScenariosAlso

Subst. dangerousor PBT/vPvB

Registration dossier - content

What is an Exposure Scenario (ES) ?

– Conditions for use:• Process description (incl. quantity used) • Operational conditions (incl. frequency and

duration of specified operations)• Risk Management Measures

– process control (e.g. closed system, local exhaust)– emission control– personal protective equipment– good hygiene / working practise.

– Other relevant information

How will the user know?

Exposure Scenarios will be attached to the Safety Data Sheet (SDS)

-> Extended Safety Data Sheets (e-SDS)

ESsESs

Annex:ESs

SafetyDataSheet

REACH actors

• Registration• Downstream users• Authorisation

Downstream users

• Obligation to identify and apply measures to control risks

• Include this in communication to customers • Obligation to communicate up in supply chain• Obligation to report to authorities• Obligation to keep and update information• Right to make use known to supplier

Manufacturer/importer

Industrial user1) use as process aid2) Incorporation into articles

Formulator 1

Formulator 2

Professional user

Distributor

Consumer

Downstream users

Who is a Downstream User

The Downstream UserMust:• Implement Operational Conditions and Risk

Management Measures communicated to him via the exposure scenarios in the SDS Annex

• If he uses the chemical outside the conditions described in the exposure scenario(s)– Inform his supplier of this use to make it an identified use– Alternatively:

• Conduct a safety assessment for his own use (and for his downstream uses if he is a supplier)

• Implement ES from own safety assessment• Report to the Agency

• Communicate further down the supply chain if he is supplier

Check SDS/ES

Use covered and

conditions

Comply with ES?

y

OK

n

n

Make use/ use conditions known

Find alternative supplier

Make DU CSA

Conditions in place meat at least conditions in suppliers ES

Implement suppliers ES

y

Simplified workflow: check of SDS/ES

n

Right to make use known to supplier

• Manufacturer and importer:– may not know the use or conditions of use – need sufficient information in order to continue

supply

• Downstream User (DU): – need continued supply (own and customers use)– need an ES to reflect the use conditions in the

market

Supply chain communication

Supplier

Downstream user(s)

Identify useSafetyDataSheet

SDS includingExposure Scenarios

(Recommended RiskManagement

Measures)

Supply chain communication

Supplier

Downstream user(s)

Identify useSafetyDataSheet

SDS includingExposure Scenarios

(Recommended RiskManagement

Measures)

Right to make use known to supplier

• What should DU communicate?– Sufficient information for preparing ES

• How to organize communication?– System developed for “brief description of use” – Standard Exposure Scenarios

• Sector organizations have a key role in developing standard Exposure Scenarios for their sector

REACH actors

• Registration

• Downstream users

• Authorisation

Authorisation• Applies to

– CMR, PBT, vPvB, ‘equivalent concern’– Substance, substance in preparation, substances in

articles.• Prioritised - Substances are progressively authorised

(as resources allow)• Substance cannot be used unless it is authorised• Authorisation applicant (industry) to show:

– adequate control of risks, or– social and economic benefits outweigh the risks and

no suitable alternatives• Commission decision based on Agency opinion

Substances of very high concern

Criteria in REACH Annex XIII:• PBT substances• vPvB substances• CMR cat 1,2 substances

But also:• Substances of equivalent concern (Art. 56f) – see

next slide

‘Equivalent level of concern’

• PBT-like substances– just not meeting one of the Annex XIII criteria, and other

information available– (bio)monitoring data– substances with PBT constituents– metabolites with PBT properties

• CMR-like (serious and irreversible effect that cannot be assessed with a standard risk assessment)

• Substances with endocrine disruption properties• Other equivalent concern substances

Overview of authorisation procedure (1)

Annex XIV

Candidate list

EU Member State or Agency

prepares an Annex XV dossier

Comments- Authorities- interested parties

Agreement / COM decision

Agency recommends priority substances

COM decision

Step 1 – Step 1 – Inclusion of substances in the list of substances Inclusion of substances in the list of substances

subject to authorisation (Annex XIV)subject to authorisation (Annex XIV)

First list within two years

Authorisation application

Who– Manufacturer(s), importer(s) and/or downstream

user(s)

For what– One or several substances– One or several uses– Applicant’s own uses, his downstream actors’

uses

When and where– Needs to be submitted to the Agency by the

application date defined in Annex XIV

Authorisation granted / not granted

Agency C’ttees’ opinions

Agency C’ttees’

draft opinions

Applicant applies for

authorisation for a substance on Annex XIV

Interested parties- Information on alternatives

Authorisation procedure

Applicant’s comments

COM decision

Step 2-

Granting (or refusing) the authorisation

COM review authorisation

Applicant’s review report

Thank you for your attention !

Articles

Registration of substances in articles

• Any article producer or importer shall register substances contained in articles if– There is intended release under normal and

reasonably foreseeable conditions of use– > 1 t/a in the articles per producer or importer– if not already registered for use in articles

Notification of substance in articles

• Any article producer or importer shall notify Substances of Very High Concern (SVHC) in articles if– they are present in those articles in amounts totalling >1 t/a

per producer or importer, and– present in those articles above a concentration of 0.1%

weight by weight, and– If not exempted via Article 7(6))

• Unless producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal of the article.

REACH Art. 7(6)

• Registration and/or notification are NOT NEEDED if the substance has already been registered for that use

Information on safe use

Any producer or importer of an article must:– Provide the recipient of the article with sufficient

information to allow safe use of the article, including, as a minimum, the name of the substance, if the article contains SVHC in a concentration above 0.1% (w/w)

– NB!• There is no tonnage trigger for this

requirement, which consequently also applies to < 1 tonne/year situations.

• No exemption via article 7(6)

Notification of SVHC in articles

EIF

April 2007 ?

12 months

Pre-registration

3 years 6 years 11 years

Agency start up 100-1000 tonnes 1-100 tonnes

[6 months]

18 months

Non-phase-in substances

Substances in Articles:• Registration: Follows the normal registration dead-lines• Notification: Starts after 3.5 years

•1000+ tonnes•CMRs 1+ tonne• very aquatic toxic (R50/53) 100+ tonnes

REACH: C and L Inventory

• Inventory :– Any company marketing a chemicals substance must

submit information on C&L of the substance (NB! No tonnage trigger)

– Public web-site managed by the Agency– deadline – 3 years

• Industry needs to co-operate to resolve differences in C&L

• Authorities may suggest EU harmonisation:– CMRs– respiratory sensitisers– Other effects (on a case by case basis)