An Introduction to REACH and GHS

1
An Introduction to REACH and GHS

• Reynold DSouza
• Indian Chemical Council

2
What is REACH

• Registration of manufactured/imported chemical
  substances gt 1 tonne/year (Industry) (Title II)
• Evaluation of substances/dossiers (Title VI)
• Authorisation for use of substances of very high
  concern. (Title VII)
• Restriction Safety net (Can be initiated by
  Member states and the Commission) (Title VII)
  (Annex XVII)
• Chemicals
• Chemical Safety Report CSR (gt10mt) (Article 14)
• Risk management measures (RMM) for chemical
  lifecycle and product Life-Cycle (LCA)
• SDS annex for downstream user.

3
Some key websites

• DG ENTR http//europa.eu.int/comm/enterprise/reac
  h/index.htm
• DG ENV http//europa.eu.int/comm/environment/chem
  icals/reach.htm
• JRC http//ecb.jrc.it/REACH/
• TGD-3 workshop http//ec.europa.eu/enterprise/rea
  ch/prep_guidance_en.htm
• Expect Overall Guidance Package

4
Life-Cycle Analysis
Fine Chemicals
Bulk chemicals
Performance chemicals
Substances, Preparations Articles
5
Exemptions

• For substances
• Exemptions from registering Specific List Annex
  IV.
• Exemptions according to Annex V (Hydrates,
  mineral ores etc)
• For certain uses
• PPORD Reduced obligations for research, product
  and process related research and development
  (PPORD) (Article 9)
• Considered already registered Plant protection
  Biocidal (Article 15)
• Medicinal, Food, Feed Active Ingredients
  exemptions (Article 2.5) and Formulations
  (Article 2.6)
• Transported Intermediates less onerous
  registration (Article 18)

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Registration

• Registration requires manufacturers and importers
  of chemicals manufactured or imported in
  quantities of 1t/a or more to obtain relevant
  information on their substances and submit the
  data in the form of a technical dossier.
• Who registers Manufacturers, importer, Only
  Representative (Article 8).
• To reduce testing on vertebrate animals, data
  sharing is required. (SIEF Article 29)
• One Objective is to pass the information on
  hazards and risks and how to manage them to
  downstream users. Chemical Safety Reportgt10MTA

RiskHazard x exposure
7
Evaluation (Title VI)

• Dossier evaluation checking
• completeness and compliance of registration
  dossiers (Title VI, Chapter 1)
• Substance evaluation
• Checking whether further information is needed on
  a substance (Title 6 Chapter 2)
• Intermediate Evaluation (Title 6 Chapter 3)

8
Authorization

• Procedure for Authorization (Title VII)
• Annex XV Dossier prepared by Agency/MS.
• Candidate List prepared. (Article 58)
• Studies carried out result in Annex XIV
  inclusion.
• SVHC definition (Substance of Very High Concern)
• CMR 12 (Carcinogenic/Mutagenic/Reproductive
  toxic)
• PBT vPvB (Persistant, Bioaccumulative, Toxic,
  Very Persistant, Very Bioacc.)
• Substances of concern
• Endocrine Disruptors (EDs)
• STOST chemical (Specific organ toxicity)
• Other

9
Articles

• Made in Europe Label
• REACH Article 7.1 Substances in articles shall
  be registered by the importer when
• The substance is present in the articles in total
  over 1 tonne per producer/importer per year, and
• The substance is intended to be released during
  normal and reasonably foreseeable conditions of
  use.
• Article 7.2 Notification of SVHCs in Articles
  
• The substance is present in the articles in total
  over 1 tonne per producer/importer per year
• The substance is present in those articles in a
  concentration above 0.1 (w/w).
• However If the producer/importer can exclude
  exposure of humans or environment he does not
  need to notify, but shall supply appropriate
  instructions to the recipients of the article.
• When 3 ½ year eif.

10
Timelines-looking back

• REACH imperatives
• Commission White paper 2001
• protection of human health and the environment
• maintenance and enhancement of the
  competitiveness of the EU chemicals industry
• prevention of the fragmentation of the internal
  market
• increased transparency
• integration of non-animal testing Minimization
  of animal testing
• conformity with the EU's international
  obligations under the WTO
• The Commission adopted the REACH proposal in 29th
  October 2003
• The European Parliament delivered its opinion at
  first reading on 17 November 2005.
• The EU Competitiveness Council, part of the
  Council of Ministers, agreed a compromise version
  of REACH at a meeting on 13 December.
• Nassauer "I haven't seen much influence from
  major producers and the big companies. As far as
  I know, there was no contact with major
  companies. At least, I had none.
• Lena Ek "He would be the only one the industry
  lobbyists missed in that case."
• Council Common Position documents June 2006

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REACH-Entry in force

• October 10th, 2006 Parliament's chief negotiator
  Guido Sacconi wins environment committee backing.
• Mandatory substitution after socio-eco analysis
• Authorizations review every five years
• 'Duty of care' principle safety when risks
  "reasonably foreseen"
• 'REACH quality label
• Promotion of alternatives to animal testing, and
• Support measures for small businesses.(SMEs)
• 13th December 2006 Expected vote in Parliament
  plenary.
• December 2006 Probable vote in Council
  (Competitiveness) and final approval of REACH.
• If the Parliament and Council fail to agree, a
  special Conciliation Committee will be convened
  under the Co-decision process.

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Implementation
April 2007
Entry in force
1yr
NONS registration
1 ½ yr
Pre-registration 12-18 month induction ends
1yr 7 months
Agency Lists
1yr 8 months
SIEF
3 yr
Phase in gt1000TPA CMR 12gt1TPA R 50-53gt 100TPA
3 yr
CL enforced
3 ½ yr
Notification of SVHC in articles
Phase in gt100TPA
6 yr
Phase in gt1TPA
11 yr
13
Important REACH studies

• KPMG Report
• Anticipated Negative Impact SME, EU-10 (New EU
  entrants)
• SPORT. Industry partnership testing of select
  chemicals under REACH.
• PRODUCE downstream users who use chemicals as
  ingredients in consumer products
• REACH Implementation Projects RIP

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REACH IMPLEMENTATION PROJECTS RIP

• RIP 1 - REACH Process Description Development of
  a detailed description of the REACH processes
• RIP 2 - REACH-IT Development of the IT system
  set up to support REACH implementation
• RIP 3 - Guidance Documents Development of
  guidance documents for industry
• RIP 4 - Guidance Documents Development of
  guidance documents for authorities
• RIP 5 - Setting up the Pre-Agency
• RIP 6 Setting up of the new Chemical Agency
  (HELSINKI)
• RIP 7 - Commission preparation for REACH

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RIP-2 IUCLID-5

• IUCLID is the IT system (software database)
• -- designed to prepare REACH-compliant
  registration dossiers to be submitted to the
  European Chemicals Agency
• -- it will be made available to Industry free of
  charge (Article 110)
• -- Migration tool from IUCLID-4
• Expected roll out January 2007

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RIP-3

• RIP 3.1 Guidance Document on Preparing the
  Technical Dossier for Registration.
• RIP 3.2 TGD on preparing the Chemical Safety
  Report.
• RIP 3.3TGD on Information Requirements on
  Intrinsic Properties of substances.
• RIP 3.4 Guidance Document on Data sharing
  (Pre-registration).
• RIP 3.5 Guidance Document on Downstream-User
  Requirements.
• RIP 3.6 Guidance on Classification and Labeling
  under Global Harmonized System.
• RIP 3.7 Guidance on preparing an Application
  Dossier for Authorization
• RIP 3.8 Guidance on fulfilling the Requirements
  for articles.
• RIP 3.9 Technical Guidance Document on carrying
  out a Socio-Economic Analysis or input for one.
• RIP 3.10 Technical Guidance Document for
  characterization and checking of Substance
  Identity.

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REACH Process

• Portfolio analysis (Including bands/exemption)
• Economic analysis and strategic options
• Literature survey
• Grouping
• Intelligent Testing
• Choose Consultant. Only Rep Option
• Pre-registration
• Interact customers/competitors
• Exposure scenarios CSR
• Classification Labeling (CL)
• Pre-registration Dossier
• Testing
• Registration

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Intelligent Testing (Annex XI)

• Read Across
• In silico
• In vitro
• HPV Program experience

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Consultants

• NOTOX, Netherlands
• SCC, Germany
• C3B Alliance Chilworth/ Brixham Labs/Chemsafe
• Dr.Knoell Consult GmbH / IBACON, Germany
• TNO, Netherlands
• Safepharm, UK
• Cambridge Environmental Assessments, UK
• Steptoe and Johnson (USA)
• Huntingdon Life Science
• JSC, UK
• RCC, Switzerland
• Ciba Expert Services Switzerland

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EU market
21
Indias Trade with EU
22
Indias Chemical Exports to EU 25 (HS 28-38)
23
An Introduction to GHS
24
Global Regulation of Chemicals
Responsible Care RC14001
USA 4929CFR
IMO/ IMDG
GHS 2008
EU
UN Model
ICAO/ IATA
OECD
ADR
Canada TDG
Target Audience Logistics--gtWorkplace--gtLifecycle
RID
25
GHS mandate

• UNCED 1992 Agenda 21, Chapter 19, Programme Area
  B, paras. 26 and 27
• 26. Globally harmonized hazard classification
  and labelling systems are not yet available to
  promote the safe use of chemicals, inter alia, at
  the workplace or in the home. Classification of
  chemicals can be made for different purposes and
  is a particularly important tool in establishing
  labelling systems. There is a need to develop
  harmonized hazard classification and labelling
  systems, building on ongoing work
• 27. A globally harmonized hazard classification
  and compatible labelling system, including
  material safety data sheets and easily
  understandable symbols, should be available, if
  feasible, by the year 2000.
• The World Summit on Sustainable Development 2002,
  in paragraph 23 (c) of its Plan of implementation
  
• Encourage countries to implement the new
  globally harmonized system for the classification
  and labeling of chemicals as soon as possible
  with a view to having the system fully
  operational by 2008.
• The first revised edition of the GHS was adopted
  in December 2004.

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GHS context

• Not legally binding but agreed at WSSD
• Building block approach. Chose country relevant
  modules
• Harmonization over time
• Living document updates every 2 years
• Competent Authority
• USA, EU, Japan 2007 January
• APEC implementation co-ordination
• Pressure for compliance from chemical companies
• GHS applies to all substances including Active
  Ingredients

27
REACH and GHS

• Certain specific detailing testing differences
• EU Law
• Extended SDS of REACH (e-SDS) to continue
• CL as per GHS
• Transition period permitted in EU for GHS switch
• Legal bodyAnnex. (In pipeline-ambitious
  timeframe)
• Annex VII Conversion table from EU system to GHS
• Building block approach
• No STOST
• Several other exemptions

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GHS Safety Data Sheets Sections

• 1. Identification (Include applications)
• 2. Hazard(s) identification
• 3. Composition/information on ingredients (Give
  structure)
• 4. First-aid measures
• 5. Fire-fighting measures
• 6. Accidental release measures
• 7. Handling and storage
• 8. Exposure controls/personal protection
• 9. Physical and chemical properties
• 10. Stability and reactivity
• 11. Toxicological information
• 12. Ecological information
• 13. Disposal considerations
• 14. Transport information
• 15. Regulatory information
• 16. Other information.

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Section 9 Physical and chemical properties

• Appearance
• Odour
• Odour threshold
• pH
• Melting point/freezing point
• Initial boiling point and boiling range
• Flash point
• Evaporation rate
• Flammability (solid, gas)
• Upper/lower flammability or
• explosive limits

• Vapour pressure
• Vapour density
• Relative density
• Solubility(ies)
• Partition coefficient n-octanol/water
• Auto-ignition temperature
• Decomposition temperature
• Viscosity

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Physical Hazards

• 1. Explosives (Chap.2.1)
• 2. Flammable gases (Chap.2.2)
• 3. Flammable aerosols (Chap.2.3)
• 4. Oxidizing gases (Chap.2.4)
• 5. Gases under pressure (Chap.2.5)
• 6. Flammable liquids (Chap.2.6)
• 7. Flammable solids (Chap.2.7)
• 8. Self-reactive substances and mixtures
  (Chap.2.8)

• 9. Pyrophoric liquids (Chap.2.9)
• 10. Pyrophoric solids (Chap.2.10)
• 11. Self-heating substances and mixtures (Chap.
  2.11)
• 12. Substances and mixtures which, in contact
  with water, emit flammable gases (Chap.2.12)
• 13. Oxidizing liquids (Chap.2.13)
• 14.Oxidizing solids (Chap.2.14)
• 15.Organic peroxides (Chap.2.15)
• 16. Corrosive to metals (Chap.2.16)

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Health and environmental hazards

• 1. Acute toxicity (Chapter 3.1)
• 2. Skin corrosion/irritation (Chapter 3.2)
• 3. Serious eye damage/eye irritation (Chapter
  3.3)
• 4. Respiratory or skin sensitization (Chapter
  3.4)
• 5. Germ cell mutagenicity (Chapter 3.5)
• 6. Carcinogenicity (Chapter 3.6)
• 7. Reproductive toxicity (Chapter 3.7)

• 8. Specific target organ systemic toxicity-
  single exposure (Chapter 3.8)
• 9. Specific target organ systemic toxicity-
  repeated exposure (Chapter 3.9)
• 10.Aspiration hazard (Chapter 3.10)
• 11.Hazardous to the aquatic environment (Chapter
  4.1)
• Fish
• Daphnia
• Algae
• Acute Chronic

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Typical Label For Drum

• Stencil part
• UN Diamond Label 100mmx100mm
• Main Label
• Product data
• Safety data
• Product Identifiers
• Proper Shipping Name or Name as per USAN, Annex
  I, US NLM
• UN Model Law class
• Signal Words
• Pictograms
• Precautionary statements Precautionary
  pictograms
• Key First aid (Like US ANSI Z 129 and 29CFR)
• Supplier Information

33
Another possible label (lt180kg drum)
34
Pictograms on the discretion of importing country.
Pictograms.
35
Acute Aquatic Toxicity
36
Statutory Message Start NOW
37
PBT criteria

• Persistence
• A substance fulfils the persistence criterion
  (P), when
• its half-life in marine water is greater than 60
  days, or
• its half-life in fresh or estuarine water is
  greater than 40 days, or
• its half-life in marine sediment is greater than
  180 days, or
• its half-life in fresh or estuarine sediment is
  greater than 120 days, or
• its half-life in soil is greater than 120 days.
• AND
• Bio-accumulative BCFgt2000
• AND
• Toxicity T
• The concentration for which no effects are
  observed over a long period, NOEC (long-term
  no-observed effect concentration) for marine or
  freshwater organisms is less than 0.01 mg/L, or
• The substance is classified as a carcinogen
  (category 1 or 2), mutagen (category 1 or 2) or
  toxic for reproduction (category 1, 2 or 3), or
• There is other evidence of chronic toxicity as
  identified by the following classifications T,
  R48, or Xn, R48 in accordance with Directive
  67/548/EEC.

38
vPvB criteria

• A chemical fulfils the very persistent criterion
  (vP), when
• the half-life for the substance in marine, fresh
  or estuarine water is greater than 60 days, or
• its half-life in marine, fresh or estuarine
  sediment is greater than 180 days, or
• its half-life in soil is greater than 180 days
• A chemical fulfils the very bio-accumulative
  criterion (vB), when
• Its bio-concentration factor is greater than 5000