The REACH Regulation

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The REACH Regulation Workshop CIQyP Argentina
Buenos Aires, 16 May 2007 Cristina Arregui
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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

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Content

• Forces that led to this new legislation
• Build-up of REACH legislation
• REACH at a glance

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Terminology

• CL 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 CL)
• 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

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Content

• Forces that led to this new legislation

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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
Risk assessment 93/67EEC (new subst) Reg 793/93
(existing subst)
Hazard assessment 67/548/EEC Classification,
packaging labelling of Dangerous Substances
Restriction on Marketing and Use 76/769/EEC
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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

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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
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Content

• Build-up of REACH legislation

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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/200
6/l_396/l_39620061230en00010849.pdf
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The REACH Regulation

• REACH is substance related
• REACH lays responsibility with producers of
  substances
• Hazards
• Risk identifications
• Risk Management Measures

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REACH Regulation - Content
SECTION CONTENT
Titles I - XV Legislative text of the Regulation
Annexes I-II Chemical Safety Report (CSR) and Safety Data Sheets (SDS)
Annex III Prioritisation criteria for substances 1-10 tonnes
Annexes IV-V Exemptions from the obligation to register
Annexes VI - XI Information requirements for Registration
Annexes XII- XVII CSR for downstream users Criteria for PBT and vPvB List of substances subject to authorisation Dossiers Socio-economic analysis Restrictions on manufacture, placing on market of dangerous substances, preparations and articles
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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

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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

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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

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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!

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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/

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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 CL and GHS
• RIP 3.7 Application dossier
• RIP3.8 Requirements for articles
• RIP 3.9 Socio-Economic analyses
• RIP 3.10 Substance identity

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Content

• REACH at a glance
• General issues
• Registration and Data Sharing
• Information in the SC and Downstream users
• Evaluation
• Authorisation
• Other Titles

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REACH at a glance

• Title I General Issues
• Structure of REACH
• Roles in REACH
• Scope of REACH

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The Structure of the REACH Processes
All substances
Substances of very high concern
Substances gt 1 ton
Substances placed on the market
Registration
Restriction
C L of CMR
C L Inventory
Authorization
Evaluation
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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 (gt1t/a) CSR and
  inform Agency

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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

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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

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REACH at a glance

• Title II Registration
• Title III Data sharing

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Registration Title II

• What do I have to register?
• All substances manufactured or imported gt1
  ton/producer/year
• Exemptions
• Reduced requirements
• Deemed to be registered

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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

• Isolated intermediates
• on-site(under strictly controlled conditions)
• transported(confirmation from user that use
  takes place under strictly controlled conditions)

• Substances on its own or in preparation
• Monomers, even if intermediates
• Substances in articles (conditions apply)

• Notified substances(67/548/EEC)
• Substances in plant protection and biocidal
  products (art. 15)

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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 gt 12 years freely
  available

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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/tonnag
  e band

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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 gt 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

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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
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Registration Title II

• Which information?

Tonnage band 1-10 10-100 100-1,000 gt 1,000
TECHNICAL DOSSIER Data Annex ? VII ? VII VIII ? VII -IX ? VII-X
CSR No ? ? ?
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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)

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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, )

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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

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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
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REACH at a glance

• Title IV Information in the supply chain
• Title V Downstream users

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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

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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 suppliers RRM for identified uses
• Otherwise DUs generally ? exemptions! perform
  assessments for unidentified uses (using
  suppliers hazard information) and inform Agency
  of such uses 1 tonne

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REACH and the supply chain
Manufacturer / Importer
European Chemicals Agency
Registration gt 1t and inside scope

• Substance on its own, in preparation or article
• depending on
• classification and labelling

Technical Dossier gt 1 t
CSR gt 10 t
Exposure Assessment and risk characterisation gt10
t and dangerous or PBT or vPvB
SDS dangerous or PBT or vPvB
Exposure Scenario(s) gt10 t Specific conditions -
waiving
Use outside exposure scenario gt 1 t
complete CSR
Downstream Users
Report if gt 1 t
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REACH at a glance

• Title VI Evaluation

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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
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REACH at a glance

• Title VII Authorisation

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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)

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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)

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Authorisation - Title VII

• SVHC need to be authorised before placing them in
  the market
• Which substances?
• Carcinogenic cat. 12
• Mutagenic cat. 12
• Reprotoxic cat. 12
• 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 12
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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)

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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

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REACH at a glance

• Other Titles

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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

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IGRACIAS POR SU ATENCION !
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Backup slides
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Measures to complete REACH
Scheduled technical reviews
1st Com report on the operation of REACH
Polymers

• Overlaps other legislation
• Registration requirements 1-10 tonnes

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

Annexes I, IV, V, XIII (PBT)
Authorisation of endocrines?
1 June 2007
EIF
2008
2012
2013
2019
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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