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Preparing for REACH implementation: The RIP process Dimosthenis A. Sarigiannis, PhD Institute for Health and Consumer Protection DG Joint Research Centre. Preparation for REACH: Commission Interim Strategy. Refocus Activities under current legislation REACH Implementation Projects (RIPs):

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slide1

Preparing for REACH implementation:

The RIP process

Dimosthenis A. Sarigiannis, PhD

Institute for Health and Consumer Protection

DG Joint Research Centre

preparation for reach commission interim strategy
Preparation for REACH: Commission Interim Strategy
  • Refocus Activities under current legislation
  • REACH Implementation Projects (RIPs):
    • RIP 1: Process descriptions
    • RIP 2: Development of IT systems (REACH-IT)
    • RIP 3: Guidance Documents and tools for industry
    • RIP 4: Guidance Documents and tools for authorities
    • RIP 5/6: Setting up the (pre-)Agency
  • Strategic partnerships (test out elements of REACH)

AIM: In close collaboration with all stakeholders develop guidance to help fulfil the obligations under REACH

slide3

3.1: Preparing the

registration dossier

3.10: Guidance on

substance ID

3.2: Preparing

the CSR

3.4: Guidance on

data-sharing

3.3: Information

requirements

RIP-3

Guidance for

Industry

3.7: Guidance on

applications for

authorisation

3.5: Guidance for

downstream users

3.8: Requirements

for articles

3.9: Guidance

on SEA

3.6: Guidance on

C&L under GHS

slide4

4.1: Guidance on

dossier evaluation

4.2: Guidance on

substance evaluation

4.5: Priority setting

for evaluation

RIP-4

Guidance for

Authorities

4.3: Inclusion of

substances in

Annex XIII

4.4: Preparation of

Annex XIV dossiers

structure of guidance package
Structure of Guidance package

Links to relevant

formats and IT tools

Web based

navigation tool

General Introduction

(RIP-1 ‘Extended’)

Harmonised C&L

and SVHC ID

Registration

  • Requirements in the regulation
  • Main tasks of the actors
  • The workflows
  • The time limits

Authorisation

C&L notification

Restrictions

DU requirements

Evaluation

Articles

Chemical Safety/

Risk assessment

Priority setting

C&L under GHS

SEA / risk

reduction options

Substance ID

organisational diagram

Member States and Observers

Commission

ENV and ENTR

Commission Working Group

Level 1

Practical Aspects of REACH

Comment

Technical

Committee

NES

Technical

Committee

C&L

Combined

LWG and

RRSM

Level 2

JRC

Comment

Specific Questions

Cleen

Stakeholder

Expert Group

JRC

Level 3

Scientific Technical Input – “Consensus”

Drafting

Contractor

Organisational Diagram
main implementation challenges ahead
Main implementation challenges ahead
  • Focus on exposure/risk management
  • Intelligent testing strategies (ITS)
  • Downstream User communication
main implementation challenges ahead1
Main implementation challenges ahead
  • Focus on exposure/risk management
  • Intelligent testing strategies (ITS)
  • Downstream User communication
slide10

Iterative CSA until exposure scenarios show that risks are controlled (risk management integrated!)

I

A

Risk Assessment

Output:

Is there a risk? (Yes/No)

?

What were the assumptions ??

Output:

Exposure Scenarios = Recipe for Risk Management

A

Need / Options for Risk Management

Output:

Risk Reduction Strategy

Industry to implement

I

(A)

  • (Authorities still have the option to intervene, e.g. via a restriction proposal)

Industry to implement

I

Today

Future

Extended

Safety

Data

Sheets

Regulation

Agreements

……..

I = Industry

A = Authorities

core tools under reach

Exposure Scenario

Core tools under REACH
  • The Chemical Safety Assessment (CSA) is the tool used to determine
  • The Chemicals Safety Report (CSR) is the tool used to record/document
  • The Safety Data Sheet (SDS) is the tool used to communicate

Conditions for use (for sufficiently protecting human health and the environment):

    • risk management measures
    • operational conditions
main implementation challenges ahead2
Main implementation challenges ahead
  • Focus on exposure/risk management
  • Intelligent testing strategies (ITS)
  • Downstream User communication
reach and the use of test animals
REACH and the use of test animals
  • Testing on vertebrate animals shall be undertaken only as a last resort (art. 23)
  • Information may be generated by other means than tests, in particular through (Q)SARs and read-across (art 12)
  • Testing may be waived on the basis of exposure considerations
  •  Legislative text + guidance should limit use of animals and prevent box-ticking
intelligent testing strategies its
Intelligent Testing Strategies (ITS)

Read Across

(Q)SARs

In-vitro

Endpoint

information

Exposure

Scenarios

(Annex VII/VIII)

Existing

information

?

TESTING

main implementation challenges ahead3
Main implementation challenges ahead
  • Focus on exposure/risk management
  • Intelligent testing strategies (ITS)
  • Downstream User communication
the downstream user
The Downstream User

Must:

  • Implement 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 necessary RMM from own safety assessment
      • Report to the Agency
  • Communicate further down the supply chain if he is supplier
supply chain communication

Supplier

Downstream user(s)

Supply chain communication

SDS including

Exposure Scenarios

(Recommended Risk

Management

Measures)

Safety

Data

Sheet

Identify use

concluding remarks trends paradigm shifts
Concluding remarks:Trends & paradigm shifts
  • Burden of proof: from public authorities to industry
  • From focus on Risk Assessment to Risk Management Measures
  • From effects-oriented to exposure-driven
  • From full testing to selective testing (ITS)
  • Attitude: from reactive to pro-active
  • Implementation of REACH has just started!
further information on rips
Further information on RIPs

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

E-mail: dimosthenis.sarigiannis@ec.europa.eu