part 2 information and data requirements risk assessment (csr)

Are you Ready for REACH? We are.

Part 2Part 2 Information and Data RequirementsInformation and Data Requirements

Risk Assessment (CSR)Risk Assessment (CSR)

Mark Selby

REACHReady Consultant


Guidance ?

ECHA Web-sitehttp://reach.jrc.it/guidance_en.htm

Available soon…….


Status of Guidance (RIPs)

• RIP 3.2 – Chemical Safety Report– Drafts issued 2006– Guidance expected ‘early 2008’

• RIP 3.3 – Data and information requirements– Final report published June 2007– Guidance expected ‘autumn 2007’


Key points on RIP 3.2

• When is a CSR required

• Who performs the CSR and how

• Exposure Scenarios

• Communication of RMM


RIP 3.2• 3.2-1 = CSA / CSR scoping work including:

– CSA Scope and content– Exposure scenarios– Industry workflows– IT issues– Special considerations for mixtures– SDS

Each the subject of its own report, August 2005


RIP 3.2- WP3• Industry workflows

– Who prepares the CSA /CSR– Duty to communicate– Definition of uses– Up-dating documentation– New items for SDS– Supply chain issues

Word doc. August 2005


WP3 – 1bPreliminary Technical Guidance Document

• Concise version, parts A and B (137 Pages)– General concepts– Guides to vPvB– Exposure Assessments– Risk Characterisation

• Full version, part C (766 Pages)– Reference Document


Technical Guidance Document, Part C

Reference Document• Health effects (ca. 100 pages),

– End points– DNEL

• Effects to health from physical hazards• Environmental (ca 140 pages)

– PNEC– vPvB / PBT

• Exposure and risk management ( > 200 pages)• CSR and SDS relevance• Appendices


Technical Guidance Document

General concepts

• Little new Science• Builds on old TGD (Directive 93/67/EEC)

for new and existing substances• New terminology• New formatting• Scope for further extension



Level of detail ?

Example : Bioaccumulative ‘B’ (approximately 2 pages)

• Introduction to concept• Use of test data from aquatic studies• Paragraph relating to estimation from Kow• Criteria for ‘very bioaccumulative’ (vB)

Basic practical advice



Level of detail ?

Example : Formatting of CSR / SDS

• One paragraph (5 lines) referring to Annex 1 of REACH

• Annex given in TGD



Level of detail ?

Example : Industrial and Use Categories for generic emission scenarios (approx 100 pages)

• Effectively the same as the old TGD• Same concepts of different levels of emissions for different industry

types• Comparison to US EPA use types • Descriptions of industry type

Needs more work….



Level of detail ?

Example : Connection to sewage plantsAnnex 4-XII (3 pages)

• Detail chenges in sewage collection over recent years• Give national comparisons for level of treatment• Backs up default data to go into models


RIP 3.2, Task III• 3.2-2 = Guidelines on IT support (Task III)

IT support for CSA and CSR (Report September 2006)

• Preliminary scoping details published, including:– Preparing example Exposure Scenarios– Aim to develop models for generic scenarios– Consider extraction of data from IUCLID for ‘automatic

CSR generator’

Progress ?


Key points of RIP 3.3

• What data is required

• Use of existing data for REACH

• Use of non-testing data

• Intelligent testing strategies

Scoping report June 2007


Data requirements

Sufficient data to meet the end points:

•Classification and Labelling agreement• Determination if PBT• Determination if vPvB s • Risk assessment (via the Chemical Safety Assessment) • Determination if need for risk management measures (RMM)

(Note tie-up with Annex XI)


Sources of data

Validity of other sources:• QSAR / Modelling• Internet• Data bases, academic sources• Internal company data • Non-regulatory guidelines• Scoring of data validity


Testing schemes

How to test difficult substances• Screening work to help avoid exposing animals

to corrosive substances• Planning of degradation test strategies• Consideration of reproductive toxicity testing• Aquatic testing• Mutagenicity testing programme


Appendices to RIP 3.3

Appendices to give detail to the points raised in the scoping report

From the tone of the scoping report, this will be based on sound science and pragmatism

Final guidelines late 2007 ?


Conclusions• RIPs need more work yet and will evolve further

– Precedents and manual of decisions key• Regulators will follow RIPs

– Allows some consistency • RIPs will need ‘lay’ guidance themselves

– Industry needs helpful guidance• RIPs are ‘guidance’ and not legislative

– If you can think of a better way of doing it, try it

There is no new science

part 2 information and data requirements risk assessment (csr)

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