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The REACH Regulation Workshop CIQyP Argentina Buenos Aires, 16 May 2007 – Cristina Arregui. The REACH System. On 30 December 2006 a New Chemicals Regulation , called " REACH “ has been published in the Official Journal of the European Union.

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slide1

The REACH Regulation

Workshop CIQyP Argentina

Buenos Aires, 16 May 2007 – Cristina Arregui

the reach system
The REACH System
  • On 30 December 2006 a New Chemicals Regulation, called "REACH“ has been published in the Official Journal of the European Union.
  • REACH stands for the Registration, Evaluation and Authorisations of Chemicals
  • The Proposed REACH Regulation will replace most of the EU chemicals legislation in place and create a European Chemicals Agency
  • It will have an impact on all companies producing, importing and using
content
Content
  • Forces that led to this new legislation
  • Build-up of REACH legislation
  • REACH at a glance
terminology
C&L Classification & Labeling

CMR Carcinogenic, Mutagenic, Toxic for Reproduction

CSA Chemical Safety Assessment

CSR Chemical Safety Report

DNELs Derived No-Effect Levels

DSD Dangerous Substances Directive

DU Downstream User

EU European Union

ES Exposure Scenario

GHS Global Harmonized System (for C&L)

M/I Manufacturer / Importer

PBT Persistent, Bioaccumulative and Toxic substance

PNEC Predicted No-Effect Concentration

PPORD Product and Process oriented Research & Development

QSAR Qualitative or Quantitative structure-activity relationship

RIP REACH Implementation Project

RMM Risk Management Measure

SDS Safety Data Sheet

SIEF Substance Information Exchange Fora

SVHC Substances of Very High Concern

VAS Vertebrate Animal Study

vPvB very Persistent and very Bioaccumulative substance

Terminology
content5
Content
  • Forces that led to this new legislation
slide6

Towards the REACH System

Registration of existing substances

Notification of new substances

79/83/EEC - 6th Amendment to 67/548/EC

92/32/EEC - 7th Amendmentto 67/548/EC

EU Chemicals Policy Review

65. . .70. . .75. . .80. . . 85. . . 90. . . 95. . . 00. . . 05 . . . 10

Hazard assessment:

67/548/EEC Classification,

packaging &

labelling of

Dangerous Substances

Risk assessment:

93/67EEC (new subst)

Reg 793/93 (existing subst)

Restriction on Marketing and Use:

76/769/EEC

the eu chemicals policy review
The EU Chemicals Policy Review
  • In April 1998, the failure of the Existing Substances Regulation caused the European Environment Council to launch the Chemicals Policy Review (CPR)
  • The Council called on the Commission to: «develop a new, integrated and coherent chemicals policy adequately reflecting the precautionary principle and the principle of sustainability and specifying the obligations incumbent on the parties involved»
political objectives of reach

Increase transparency

Political Objectives of REACH

Maintenance and enhancement of chemical industry competitiveness

Prevent fragmentation of internal market

Integration with international efforts

Promotion of non-animal testing

Protection of human health and environment

Conformity with EU international obligations under the WTO

DG ENTR DG ENV

content9
Content
  • Build-up of REACH legislation
the reach regulation
The REACH Regulation
  • Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 Dec 2006

concerning the registration Evaluation, Authorisation and Restrictions of Chemicals (REACH)

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_396/l_39620061230en00010849.pdf

the reach regulation11
The REACH Regulation
  • REACH is substance related
  • REACH lays responsibility with producers of substances
    • Hazards
    • Risk identifications
    • Risk Management Measures
reach titles
REACH Titles
  • Title I: General issues
  • Title II: Registration of substances
  • Title III: Data sharing and avoidance of unnecessary testing
  • Title IV: Information in the supply chain
  • Title V: Downstream users
  • Title IV: Evaluation
  • Title VI: Authorisation
  • Title VIII: Restrictions on the manufacturing, placing on the market and use of certain dangerous substances and preparations
  • Title IX: Fees and charges
  • Title X: Agency
  • Title XI: Classification and labelling inventory
  • Title XII: Information
  • Title XIII: Competent authorities
  • Title XIV: Enforcement
  • Title XV: Transitional and final provisions
slide14

Main Steps in REACH

A single system for non-phase-in (new) and phase-in (existing) substances

  • Pre-Registration: data sharing and avoidance of unnecessary testing
  • Registration of substances of 1 ton or more per M/I/year
  • Information in the supply chain; downstream users
  • Evaluation of dossiers by Agency and Member States
  • Authorisation for substances of very high concern
  • Restrictions – the safety net

The Agency to manage the system

european chemicals agency
European Chemicals Agency
  • Located in Helsinki
  • Operational 1 year after REACH entries into force
  • Main responsibilities:
    • (Pre-)registration
    • Evaluation
    • Authorisation
    • Helpdesk
    • REACH IT and IUCLID 5
reach challenges
REACH - challenges

The challenge for chemical industry

    • assess (including data generation)
    • document (Chemical Safety Report)
    • register (together with other

producers and downstream users)

    • communicate (via Safety Data Sheet)
  • 30.000 substances in 11 years!
reach implementation projects rips
REACH Implementation Projects - RIPs
  • AIM:To develop in close collaboration with all stakeholders guidance helping to fulfil the obligations under REACH
  • RIP 1: REACH Process Description;
  • RIP 2: REACH – IT;
  • RIP 3: Technical Guidance and Tools for Industry;
  • RIP 4: Technical Guidance and Tools for Authorities;
  • RIP 5 & 6: Setting up the Agency
  • RIP 7: Preparation of the new tasks for the Commission
  • More info:http://ecb.jrc.it/REACH/
rip 3 subprojects
RIP 3 subprojects
  • RIP 3.1: Preparing Technical dossier
  • RIP 3.2: Preparing CSA/CSR
  • RIP 3.3: Information requirements
  • RIP 3.4: Data sharing
  • RIP 3.5: Down Stream User requirements
  • RIP 3.6: C&L and GHS
  • RIP 3.7: Application dossier
  • RIP3.8: Requirements for articles
  • RIP 3.9: Socio-Economic analyses
  • RIP 3.10: Substance identity
content19
Content
  • REACH at a glance
    • General issues
    • Registration and Data Sharing
    • Information in the SC and Downstream users
    • Evaluation
    • Authorisation
    • Other Titles
reach at a glance
REACH at a glance
  • Title I General Issues
    • Structure of REACH
    • Roles in REACH
    • Scope of REACH
the structure of the reach processes
The Structure of the REACH Processes

All substances

Substances of

very high concern

Substances

> 1 ton

Substances placed

on the market

Restriction

Registration

C& L of

CMR

C& L

Inventory

Authorization

Evaluation

roles in reach
Roles in REACH
  • Manufacturer/Importer:
    • should (pre)register substances Produced/Imported by him
    • Should do CSA/CSR for substance
    • RMM for intended use, extended SDS (include ESs)
    • Communicate down stream supply chain
  • Downstream User:
    • Should communicate intended use to M/I
    • Should follow advise SDS and apply advised RMM
    • In case of non-identified use (>1t/a): CSR and inform Agency
roles in reach23
Roles in REACH
  • Distributor:
    • Downstream communication on ESs and RMM
    • Upstream information on usage and identified use for registration
  • Only representative:
    • Importer may appoint only representative to fulfil his requirements
    • EU based
  • Third party representative:
    • M/I appoint to represent in certain activities
    • To protect confidentiality and CBI
the scope of reach
The Scope of REACH
  • REACH covers:
    • Manufacture, import, placing on the market and use of substances
    • Substances “on their own”, in preparations or in articles
  • General exemption from scope: radioactive substances, substances to custom supervision, non-isolated intermediates
  • Several exemptions from the REACH requirements. Different at Registration, Authorization, Restrictions

30,000 substances

reach at a glance25
REACH at a glance
  • Title II Registration
  • Title III Data sharing
registration title ii
Registration – Title II

What do I have to register?

  • All substances manufactured or imported >1 ton/producer/year
  • Exemptions
  • Reduced requirements
  • Deemed to be registered
slide27

Manufacturer

  • Importer
  • EU Representative of non-EU manufacturer

Deemed to be Registered

more than 1 t/yr

Obligation to register

Exemptions for

  • Substances to the extent they are used for a specific use covered by other legislation (art. 2)
  • Polymers
  • Well known substance (Annex IVI)
  • Inappropriate (Annex V)
  • COM reviews Annex IV and V within one year after entry into force
  • PPORD (time limited)
  • Re-importation
  • Registered substances being recovered in the Community

General :

Full Dossier

Special :

Reduced Dossier

  • Substances on its own or in preparation
  • Monomers, even if intermediates
  • Substances in articles (conditions apply)
  • Isolated intermediates
  • on-site(under strictly controlled conditions)
  • transported(confirmation from user that use takes place under strictly controlled conditions)
  • Notified substances(67/548/EEC)
  • Substances in plant protection and biocidal products (art. 15)
data sharing and avoidance of unnecessary testing title iii
Data sharing and avoidance of unnecessary testing - Title III

Potential registrants to share studies before registration - How?

  • Non phase-in substances: Send a enquiry to the Agency with specific information
  • Phase in substances: Duty to Pre-register – send specific information to the Agency to join a SIEF
  • Summaries submitted more > 12 years freely available
pre registration information
Pre-registration information

Pre-registration phase: 12 – 18 months after REACH entries into force

  • Name and address of the producer (or third party)
  • Substance name & EINECs and CAS n° (if available)
  • Substance name (as previously) for where either (Q)SARs are available or read-across is applicable.
  • The envisaged deadline for the registration/tonnage band
sief for phase in substances
SIEF for Phase-in Substances
  • Aim: exchange information to minimise duplication of tests and to agree on classification and labelling
  • SIEF participants provide others with existing studies, react to requests by others, identify needs for further studies and arrange to carry them out
  • Sharing of tests involving vertebrate animals mandatory
    • if participant refuses to share => stop proceeding registration and sanctions
    • rest of SIEF proceeds without fulfilling this requirement
  • Sharing of tests involving non vertebrate animals and phys-chem data obligatory at request of another potential registrant
pre registration registration timetable for phase in substances

1000 t/y

CMR 1&2

R50-53 >100 t/y

Pre-registration & Registration timetable for phase - in substances

1 June 2007: REACH entries into force

1 Jun 2018

Pre-registration

18 months

All substances

1 Jun 2008

1 Dec

2008

1 Jun 2013

1 Dec

2010

2,5 years

5 years

3,5 years

Registration

Registration

Registration

100 - 1000 t/y

1 - 100 t/y

11 years

3,5 years

6 years

slide32

Registration – Title II

Which information?

information requirements
Information Requirements

What should include the Technical Dossier?

  • Identity of manufacturer or importer, identity of substance
  • Information about manufacturing process and produced quantity incl. all identified use(s)
  • Classification and labelling
  • Guidance on safe use (storage, disposal, first aid measures)
  • All relevant and available test data (incl. a literature search) but as a minimum summaries and “robust study summaries” of test data (Annex VII-X)
  • Proposal for additional tests
  • Exposure information for 1-10 tonnes
  • Indication as to which information has been reviewed by an independent assessor
  • Request for confidentiality in accordance to art. 118 (2)
information requirements34
Information Requirements

Registration Annexes

Annex VII

  • Physicochemical properties
  • Basic human health data
  • Short term aquatic toxicity

Annex VIII

  • Human health data (including in vivo)
  • Ecotoxicological data

Annex IX and Annex X

  • Long term, repeat dose, chronic, fate etc

Annex XI

  • Adaptations of the testing regimes (exposure waiving, read-across, QSARs, )
information requirements35
Information Requirements

What is the Chemical Safety ssessment/Report?

  • Shall consider all stages of the life-cycle of a substance as defined by the identified uses and will contain the following information:

1. Human health hazard assessment

  • 2. Human health hazard assessment of physico-chemical properties
  • 3. Environmental hazard assessment
  • 4. PBT and vPvB assessment
  • - - - - if dangerous or a PBT or vPvB - - - -
  • 5. Exposure assessment
  • 6. Risk characterization
  • CSR rules defined in Annex I
joint submission of data between multiple registrants
Joint submission of data between multiple registrants

S E P A R A T E L Y

C H O I C E

JOINT

Identification of manufacturer or importer

Identification of substance

Information on manufacture and use

For substances 1 to 10 t, exposure information (section 6 of Annex VI)

Indication about review by an assessor

Guidance on safe use (section 5 of Annex VI)

Chemical Safety Report

Classification and labelling

Study summaries and robust study summaries of information derived from application of Annexes VII to XI

Proposals for testing where listed in Annexes IX and X

Indications about review by an assessor

reach at a glance37
REACH at a glance
  • Title IV Information in the supply chain
  • Title V Downstream users
information in the supply chain downstream users title iv v
Information in the supply chain Downstream Users - Title IV & V
  • Duty to communicate information in the supply chain
    • Through Safety data Sheet for classified substances and PBTs / vPvB
    • Specific information when no SDS is required
  • Downstream users have also duties!
  • Downstream users must prepare a CSR for a use outside the conditions described in an exposure scenario communicated to him in a SDS
downstream users du
Downstream Users (DU)
  • Manufacturer/importer CSR to cover all uses identified by downstream users
  • DU benefit from choice of:
    • supplier carrying out assessment, or
    • for confidentiality reasons doing own assessment
  • Limited work for DUs
    • If using suppliers CSR, DUs just have to implement supplier’s RRM for identified uses
    • Otherwise DUs generally [ exemptions!] perform assessments for ‘unidentified uses’ (using supplier’s hazard information) and inform Agency of such uses ≥ 1 tonne
reach and the supply chain
REACH and the supply chain

Manufacturer / Importer

European Chemicals Agency

Registration:

> 1t and inside scope

Substance on its own, in preparation or article

depending on:

  • classification and labelling

Technical Dossier

> 1 t

CSR > 10 t

Exposure Assessment and risk

characterisation >10 t and

dangerous or PBT or vPvB

SDS

dangerous or PBT or vPvB

Exposure Scenario(s) >10 t

Specific conditions - waiving

Use outside exposure

scenario > 1 t

complete CSR

Downstream Users

Report if > 1 t

reach at a glance41
REACH at a glance
  • Title VI Evaluation
evaluation title vi
Evaluation – Title VI

Substances will be evaluated by the Agency and Member States - What will they evaluate?

  • Dossier evaluation – done by the Agency
    • Examination of testing proposals: to prevent unnecessary animal testing, i.e. the repetition of existing tests, and poor quality tests
    • Compliance Check: the Agency may check the compliance of registration dossiers to check if they comply with the registration requirements. At least 5% of dossiers should be checked;
  • Substance evaluation – done by MSs
    • if it is suspected that a substance presents a risk and further data is needed;

Community rolling action plan

reach at a glance43
REACH at a glance
  • Title VII Authorisation
the authorization process
The Authorization Process
  • REACH requires the pre-market approval (Authorization) of «Substances of Very High Concern» (SVHC), selected on the basis of their hazardous properties
  • The Authorization decision is taken by the Commission on the basis of risk and socio-economic assessments, taking into account available suitable alternatives
  • The Authorization is use-specific, company-specific and will be subject to revsion on a case by case basis
  • The Authorization Process consists of 3 phases:
  • Selection  Prioritization  Authorization (or “ban”)
scope of the authorization process
Scope of the Authorization Process
  • Authorization applies to each manufacturer/ importer or downstream user who markets a substance (as such, in preparations, or articles) listed in Annex XIV for use or uses it himself
  • No volume threshold
  • No polymer exemption
  • A series of exemptions for some regulated products (e.g. Food-contact materials and cosmetics are exempted from the human health assessment part of the process)
authorisation title vii
Authorisation - Title VII

SVHC need to be authorised before placing them in the market

Which substances?

  • Carcinogenic cat. 1&2
  • Mutagenic cat. 1&2
  • Reprotoxic cat. 1&2
  • Persistant, Bioacumulative and Toxic – PBTs (Annex XIII Criteria).
  • Very Persistant, Very Bioacumulative – vPvBs (Annex XII Criteria)
  • identified from scientific evidence as causing probable serious effects to humans or the environment equivalent to those above on a case-by-case basis, such as endocrine disrupters or other PBTs/vPvBs

CMRs 1&2

authorisation of svhc
Authorisation of SVHC

What do I have to do to apply for an authorisation?

  • Application to the Agency to include:
    • the identity of the substance(s) and name/contact of the M/I
    • which use(s) the authorisation is sought
    • CSR, unless already submitted as part of the registration;
    • an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution, and including information about any relevant research and development activities by the applicant, if appropriate;
    • where the analysis referred to in paragraph (e) shows that suitable alternatives are available, a substitution plan including a timetable for proposed actions by the applicant
  • Agency Committees opinions, open for comments
  • Commission decision on the Authorisation (Comitology)
authorisation process granting
Authorisation process: granting

In which cases I will get an authorisation and for how long?

  • Granting of authorisation
    • if the risks are adequately controlled except for:
      • PBTs & vPvBs according to Annex XIII
      • Substances of equivalent concern having PBTs & vPvBs properties
      • Other substances for which it is not possible to determine a threshold (Annex I, section 6.4),
    • if the socio-economic benefits outweigh the risk and if there are no suitable alternative substances or technologies.
  • Duration: time limited review on a case by case basis based on all relevant information including the following elements:
    • The risk posed by the substance including RRM and SE benefits
    • Analysis of alternatives or substitution plan submitted
reach at a glance49
REACH at a glance
  • Other Titles
other titles
Other Titles
  • Title VIII Restrictions
  • Title IX Fees and Charges
  • Title X Agency
  • Title XI Classification and Labelling inventory
  • Title XII Information
  • Title XIII Competent Authorities
  • Title XIV Enforcement
  • Title XV Transitional and Final provisions
measures to complete reach
Measures to complete REACH

Scheduled technical reviews

1st Com report on the operation of REACH

Overlaps other legislation

Registration requirements 1-10 tonnes

Polymers

  • CSA / CSR 1-10 t ?
  • Info requirements for articles
  • VAT reprotox

Annexes

I, IV, V,

XIII (PBT)

Authorisation of endocrines?

1 June 2007

EIF

2012

2013

2019

2008

reviews 1 j une 2008
Reviews 1 June 2008
  • Annex I (Chemical Safety Assessment/Report):
    • Adequate control criteria (authorisation)
      • RIP 3.2/Task II will give input (thresholds for CMRs)
  • Annexes IV and V (exemptions from registration)
    • Establishment of coherent rules
    • Identify substances according to the rules
  • Annex XIII (PBT)
    • Further development of criteria
  • The fees for registration and authorisation will be set out in a Commission Regulation adopted by comitology.
    • Proposal before the end of the year