Disclaimer:

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Stretched by REACH?
Philip Charlesworth, BA(Hons),MSc.,Barrister Envir
onmental Advisors Ltd
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• 9.10
• General overview of REACH and its
• Relevance.
• 10.45
• Tea/coffee break.
• 11.00
• Law, enforcement and the likelihood and
• consequences of non-compliance. The
• relationship with existing legislation.
• 13.00
• Lunch and close.

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From OECD ENV/JM/MONO(2004)8
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Distribute, sell, use professionally
Import
Manufacture
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(No Transcript)
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Substances

• anti-static agents
• colouring agents
• corrosion inhibitors
• fillers
• flame retardants and fire preventing agents
• foaming agents
• biocides, non-agricultural (biocidal products
  used in film preservatives)
• process regulators
• softeners
• stabilisers
• viscosity adjusters

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Markets, products and processes

• Packaging
• Building and construction
• Electrical and electronic
• Automotive and transport
• Agriculture
• Other - housewares, toys, mechanical engineering
  etc.
• Basic polymers are sold to processing companies,
  serving an immense range of end-user markets.
• Compression moulding
• CompositesThermoforming
• Rotomoulding
• Blow moulding
• Extrusion
• Injection moulding  

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The legislation basics

• Manufacture chemical substances in the EU
• Import chemical substances into the EU
• Manufacture product in the EU using chemical
  substances
• Use chemical substances in the course of business
  in the EU

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Official titles

• Regulation 1907/2006
• June 1 2007
• Directive 2006/121/EC adapting existing Directive
  67/548/EEC
• June 1 2008

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Whats changed

• Industry to bare the burden of risk assessments
• Downstream user obligations

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• European Chemicals Agency (the Agency)
• Complimenting existing legislation
• Registration
• Evaluation
• Authorisation
• Restriction

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Exemption from registration include

• Polymers.
• Substances under customs control.
• Waste.
• Substances considered to cause minimum risk.
• Chemical substance(s) formed as expected from the
  reaction of known substances. (The known
  substances are used to impart particular
  characteristic(s) i.e. plasticiser).

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Article 1(3)

• This Regulation is based on the principle that
  it is for manufacturers, importers and downstream
  users to ensure that they manufacture, place on
  the market or use such substances that do not
  adversely affect human health or the environment.
  Its provisions are underpinned by the
  precautionary principle.

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Polymers are exempt from Registration
Monomers are not, Polymers are not exempt from
authorisation and restriction
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Registration

• Manufacture/import a chemical substance (except
  pure polymer)
• gt 1 tonne
• Per year
• Per company

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Substances in articles

• Substances intended to be released from a
  product(ie ink from a biro)
• Substances contained in the
• article that are likely to
• result in risk to human health or
• the environment
• The substances havent already
• been registered up the supply
• chain (and that registration
• covers their use in the
• articles already)

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Evaluation includes

• Registration dossier evaluation
• Substance risk evaluation

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Authorisation includes

• ECA permission needed for continued use of
  substances of high concern
• Plan for substitution and phasing out substances
  of high concern

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Restriction

• ECA Restrict use of identified chemicals where
  risk is unacceptable

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What to do if you manufacture a substance and/or
import a substance that is not exempted
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Substances subject to NONS are considered
registered
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Pre-register Phase-in substances
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Phase-in substance

• E.IN.E.C.S.
• Manufactured in EU since 1981 but not sold in EU
• Previously sold in the EU as polymers (prior to
  amendment of Directive 67/548/EEC) and now
  considered as no longer polymers

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Must my company personally register?

• Appoint a third party (Art 4)
• Sole representative for non-EU entities(Art 8)
• Joint submission of data(Art 11)

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Registration phase-in
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Duty to pre-register

• 1st June 2008 to 1st December 2008
• What if I miss the 1st December 2008?

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Pre-registration information

• Gather share existing info
• ID substances
• Estimate yearly tonnage
• Composition of waste/handling when discarded as
  waste
• State uses not recommended
• Guidance on safe use
• If lead registrant, their details
• OSOR
• Declaration of existence of commercially
  confidential info

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Sharing is not optional

• Art 29 SIEF
• Avoid duplication
• Avoid unnecessary testing
• Owner of data can make a charge
• SIEFs terminate with the last registration
  deadline on 1st June 2018
• Sharing has benefits?

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Full Registration

• Recap a word on polymers

• Only need to register the monomer component if
• gt2 un-reacted monomer w/w is present and/or
• Monomer not already registered and/or
• Monomer present gt 1 tonne per year per company
  manufacturing/importing the monomer

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A word on the exemptions from registration

• Substances that are outside the scope of REACH ie
  their intrinsic nature is benign
• Substances covered by other legislation
• Polymers may not be exempt by 1st June 2008

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Full registration

• As a minimum basic info required ie flashpoint,
  flammability, oxidising properties, skin irritant
  etc
• technical dossier
• IP

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Registration and intermediates

• Non-isolated exempt (Art 2)
• Transported isolated (as a monomer) exempt (Art
  18)
• On-site isolated (as a monomer) exempt (Art 6)

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Downstream users

• Anyone using a substance on its own or in a
  preparation eg professional painter or
  masterbatch formulator, manufacturer of
  articles.

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Downstream users and supply chain

• Supply chain obligations from 1st June 2007
• Info to be passed down the supply chain
• Info to be passed up the supply chain
• Costs

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Information held in a supply chain?
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The Annexesa brief overview
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ANNEX I

• Chemical safety reports (CSRs)
• Can group substances with similar characteristics
• Must declare that any exposure scenarios have
  been appropriately communicated down supply chain

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Annex II

• Safety Data Sheets (SDS)
• ID composition/ingredients
• Need only list the most common uses
• Safe handling
• Waste disposal

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Annexes III to XI

• III cat. 1 or 2 CMRs. QSARs
• IV exemptions from registration
• V exemptions from registration
• VI details needed to registrate
• VII substances gt 1 tonne
• VIII substances gt 10 tonnes
• IX substances gt 100 tonnes
• X substances gt 1000 tonnes
• XI adaptation to testing regime

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Annex XII to Appendix 10

• XII assessment by downstream users
• XIII PBT vPvB identification
• XIV ECA to compile hit list
• XV dossiers
• XVI Socio-economic analysis
• XVII - restrictions
• Appendices 1 to 6
• Appendix 7
• Appendices 8 to 10

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Coffee/tea?
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The precautionary principle
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An example

• Epichlorhydrin Bisphenol A

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Exposure is minimal?
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Evidence?
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Pfizer v European Commission 2002 case T-13/99

• Where there is scientific uncertainty as to the
  existence or extent of risks to human health, the
  Community institutions may, by reason of the
  precautionary principle, take protective measures
  without having to wait until the reality and
  seriousness of those risks become fully apparent

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A word from the Federation of Small Businesses

• Form-filling and providing information to
  regulators
• Diverting owners/managers from wealth creation
• Costs of reduced productivity
• Compliance actions and associated
  administration
• Processing the inspection visit
• Increases in non-labour costs
• Difficulties in hiring new staff

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Modern regulation
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Alison Dugmore v Swansea and Morriston NHS Trusts
2002 EWCA Civ 1689

• It is by no means incompatible with their
  purpose that an employer who fails to discover a
  risk or rates it so low that he takes no
  precautions against it should nevertheless be
  liable to the employee who suffers as a result

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A frisky regulator?

• R v Friskies Petcare UK Ltd 2000CA (Criminal
  Division)

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Enforcement

• Examples of activities where UK enforcement is
  needed are
• The manufacture, import, sale, supply or use
  of substances without the appropriate
  registration.
• Using a hazardous substance outside the terms
  of an authorisation or contrary to a restriction.
• Failure to provide required information up and
  down the supply chain.
• Failure to comply with other duties regarding
  information, e.g. workers or consumers rights
  of access to information.
• Failure to comply with the duty to apply
  recommendations, e.g. in safety assessments.
• Failure to comply with the duties to
  co-operate and to supply information (in a timely
  manner).

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A chance to speak up?

• British Aerosol Manufacturers Association (BAMA)
• British Chamber of Commerce
• British Coatings Federation Ltd
• British Footwear Manufacturers Association
• British Furniture Manufacturers
• British Hardware and Housewares Manufacturers'
  Association
• British Printing Industries Federation
• British Retail Consortium
• British Rubber Manufacturers Association
• British Surface Treatment SuppliersAssociation
• CBI
• Engineering Employers Federation (EEF)
• Federation of Small Businesses
• Packaging Industrial Films Association
• Paint Research Association
• Performance Textile Association
• Society of Dyers Colourists
• Society of Motor Manufacturers Traders Ltd

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Business as usual?

• HSE COSHH
• EA IPPC (Part A permits)
• EHO IPPC (Part B permits)
• Trading standards (Consumer protection)

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legislation overlap

• Directive 76/769/EEC (Dangerous substances)
• Directive 2001/95/EEC (General Product Safety)
• Directive 2002/95/EC (RoHS)
• Directive 2002/96/EC (WEEE)
• Directive 2000/53/EC (ELV)
• Directive 96/91/EC (IPPC)

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The significance of a Regulation

• A regulation is of individual concern to a
  person where, in the light of the specific
  circumstances of the case concerned, it adversely
  affects a particular right on which that person
  could rely

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A case of sour grapes?

• Antonio Munoz Cia SA v Frumar Ltd 2002 (Case
  C-253/00)

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Waste Recycling

• If the recovery of waste results in the
  manufacture of a different substance,preparation
  or article, the provisions of REACH apply to this
  different substance,preparation or article.

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Question. When is waste not waste?
Answer. When it is a secondary material
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The main points?
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You could now decide

• youre out of REACH
• youre within REACH
• if you need to REACH out for help

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Further reading?

• Case study on Announcement effect in the market
  related to the candidate list of substances
  subject to authorisation FINAL REPORT JANUARY
  2007
• Journal of Environmental Law (2007) 19 JEL (103)
  1 March 2007 Jacqueline Peel, University of
  Melbourne

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