The EU REACH Chemicals Regulatory Regime

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The EU REACH Chemicals Regulatory Regime
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REACH
What does the acronym stand for ?

• R Registration
• E Evaluation
• A Authorisation
• CH Chemicals
• The missing letter R Restriction

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REACH
What is it exactly ?

• REACH is a new EU chemicals regulatory regime
  concerning businesses manufacturing in, or
  importing chemical substances into, the EU
• Businesses affected by REACH have to Register
  their substances with a new EU agency, the
  European Chemicals Agency (ECHA) in Helsinki -
  each company in a group must comply, i.e a
  company group cant generically Register

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REACH
What is the main requirement ?

• As a market-prerequisite industry has to
  demonstrate, through Registration, that its
  substances are safe for human health and the
  environment, i.e
• No Data No Market !

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REACH

• Is my business affected ?
• REACH affects a very wide range of businesses
• Upstream chemical substance manufacturers and
  importers - they have the main obligations to
  meet under REACH
• Downstream professional users, re-formulators,
  distributors and retailers - they have lesser
  obligations to meet under REACH, but which are
  significant nevertheless

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REACH

• What if my business is not located in the EU ?
• REACH affects businesses globally
• Chemical substance manufacturers located outside
  the EU cannot themselves Register as such
• But, in order for such companies to be able to
  continue to sell their substances on the EU
  market such substances must nevertheless be
  Registered
• How can this be done ?
• Either, use importers, or, appoint an Only
  Representative, who will then do the
  Registration

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REACH

• What does it mean if someone else Registers
  for my business ?
• Importer-Ensure that you work with quality
  importers because otherwise you could face
  problems
• Because it means handing over sensitive business
  and technical information to a party who may not
  necessarily be able to guarantee the
  confidentiality of the information
• Such a party may also be acting as an importer
  for a competitor of the non-EU based company
  raising other concerns (and the importer could
  even become a competitor itself)?
• Significantly, the importer becomes the owner of
  the actual Registration thus limiting not only
  the control of the non-EU-based company in the
  REACH process but also possibly limiting EU
  market access of the company's chemical substance

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REACH

• What does it mean if someone else Registers
  for my business ?
• Only Representative-
• What Is This ?
• A natural or legal person established in the EU
  to fulfil the REACH obligations of importers
• They must have
• sufficient background in the practical handling
  of substances, and, the information related to
  them
• they must keep available and up-to-date
  information on quantities imported and customers
  sold to, as well as keep information on the
  supply of the latest update of the safety data
  sheet

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REACH

• What does it mean if someone else Registers for
  my business ?
• Using an Only Representative has advantages and
  disadvantages
• Only Representatives will become the downstream
  users of such substances, and thereby take on
  certain other REACH obligations
• The sufficient background in the practical
  handling of substances etc requirement is vague
  enough to allow a broad range of persons to put
  themselves forward as Only Representatives but
  also leaves open the risk that such persons are
  not sufficiently skilled in these areas
• The obligation to communicate with others in the
  supply chain may raise concerns that, for some
  supply chains, non-EU manufacturers will be wary
  of providing sensitive commercial information
  concerning their production and export plans to
  an Only Representative over whom they may have
  little control in reality

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REACH

• Does REACH only concern chemical substances?

• REACH covers chemical Substances,
  Preparations (mixtures of substances), and,
  Articles
• What is an Article ?
• an object which during production is given a
  special shape, surface or design which
  determines its function to a greater degree than
  does its chemical composition

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REACH

• Are there any exclusions ?
• A small number of chemical substances are totally
  excluded, for example
• - substances which occur in nature (unprocessed
  or processed only by manual, mechanical or
  gravitational means, by dissolution in water, by
  flotation, by extraction with water, by steam
  distillation or by heating solely to remove
  water, or which is extracted from air by any
  means)?
• A larger group of chemical substances are
  excluded from Registration and/or
  Authorisation, for example
• food additives, cosmetics, medicinal products etc
  - the wording of these exceptions needs to be
  examined carefully before any conclusions can be
  drawn as to whether these exceptions apply or not

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REACH

• What is Registration ?
• Businesses which manufacture or import substances
  caught by REACH in quantities of 1 tonne or more
  per year must Register their substances with
  the ECHA
• Registration essentially requires the
  submission of a significant amount of detailed
  technical material (using the IUCLID 5
  software) about a given substance - the
  information requirements increase with respect to
  tonnage and/or the hazardous nature of a given
  substance

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REACH

• What procedures apply to articles ?
• Registration and Notification-

• Where the substance is present in an article in
  quantities of over 1 ton per producer or importer
  per year, and, it is intended that the substance
  will be released under normal or reasonably
  foreseeable conditions of use, it must be
  Registered
• In addition, where the substance is present in
  an article in quantities of over 1 ton per
  producer or importer per year, and, the substance
  is present in an article above a concentration of
  0.1 weight-by-weight, and, the substance is one
  of Very High Concern, and, the producer or
  importer cannot exclude exposure to humans or the
  environment during normal or reasonably
  foreseeable conditions of use of the article, it
  must be Notified to the ECHA

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REACH

• What is Pre-registration ?
• Due to the many substances expected to be
  Registered there will be a transitional period
  for phase-in substances
• Pre-registration - 1 June to 30 November 2008
  (this also applies to Articles) - a special
  software tool will be available for this process
  (IUCLID 5 Plug-In)?
• The major advantage of Pre-registering is that
  it buys transition time for the eventual full
  Registration of a given substance, which
  operates in a time-phased manner
• Using an Only Representative for
  Pre-Registration should provide anonymity for
  the substance producer using an Only
  Representative (and thereby strengthen
  confidentiality)

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REACH

• What are Phase-In substances ?
• Phase-in substances are defined as those
• Either listed in the European Inventory Of
  Existing Commercial Chemical Substances
  (EINECS)?
• Or, manufactured in the EU (or in 1995 or 2004 EU
  accession countries), but not placed on the EU
  market by the manufacturer or importer, at least
  once 15 years before the entry into force of
  REACH (1 June 2007)?
• Or placed on the market (by a manufacturer or
  importer) in the EU (or in 1995 or 2004 EU
  accession countries) before entry into force of
  REACH (1 June 2007) and was considered as having
  been notified under (the relevant provisions of)
  EU (classification and labelling) Directive
  67/548, and does not meet the REACH
  definition of a polymer

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REACH

• Do I have to share data ?
• Once Pre-registration has been undertaken it is
  then mandatory for businesses to formally get
  together in groups known as Substance
  Information Exchange Forum (SIEFs) in order to
  share existing animal test data on substance so
  as to minimise further testing that may be needed
  for Registration
• The SIEFs will in effect operate as consortia
  with one company in the group taking the lead and
  submitting the required Registration
  information to the ECHA

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REACH

• What information must be submitted ?
• For substances of 10 tonnes or more per year on
  the EU market, a Chemical Safety Report must be
  submitted to the ECHA which will contain a
  Chemical Safety Assessment
• This exercise is essentially a risk assessment
  where the Registrant takes account in
  particular of the life-cycle risk management
  measures that will be implemented, either for the
  Registrants own uses and/or for those uses
  which will be proposed to users further down the
  supply chain for their own particular uses
• Upstream manufacturers and downstream users need
  to work closely together on this exercise,
  especially as regards so-called Exposure
  Scenarios

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REACH

• What is Evaluation ?
• There are two types of Evaluation
• A dossier completeness check where the ECHA will
  check a percentage of the dossiers submitted
  under Registration to ensure that the dossiers
  contain the right information - requests for
  further information may follow
• For certain priority substances so identified
  by the ECHA a fuller substantive dossier
  appraisal will be carried out (for which more
  information will probably need to be submitted by
  companies), following which such substances may
  need to follow either the Authorisation or the
  Restriction processes

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REACH

• What is Authorisation ?
• All uses of chemical substances with intrinsic
  properties of Very High Concern must be
  authorised before they can be placed on the
  market (SVHC)?
• (Substances of) Very High Concern essentially
  means that the effects of the hazardous
  properties of the substance in question on living
  organisms are usually irreversible - notably,
  this will include substances that are
  carcinogenic, bio-accumulate, or persist in the
  environment (CMR, PBT, vPvB)?
• The ECHA will compile and publish a Priority
  List of substances that will go through
  Authorisation

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REACH

• What does Authorisation consist of ?
• Authorisation will apply to particular uses of
  a chemical substance (including articles) and
  will only be granted if the manufacturer or
  importer can demonstrate that the risks from the
  uses concerned can be adequately controlled, or,
  that the socio-economic benefits of the use of
  the chemical outweighs the risks and there are no
  suitable alternatives
• Businesses will need to submit a substitution
  plan when applying for Authorisation, i.e a
  plan for eventually replacing the given
  Authorised substance
• Authorisation will be valid down the supply
  chain, with certain regulatory obligations on
  users

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REACH

• What is Restriction ?
• Separate to the Authorisation
• process, depending on the
• circumstances, certain substances
• may have Restrictions imposed
• on them, for example, limiting the
• uses of the given substance
• (which may even amount to
• a ban)?

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REACH

• Is there any other other legislation/material ?
• Further EU legislation will supplement REACH to
  specifically deal with classification and
  labelling issues, namely the (Draft) EU
  Regulation On Classification And Labelling Of
  Substances And Mixtures Based On The Globally
  Harmonised System, which is expected to be
  agreed in 2008
• Further supplemental REACH legislation is also
  needed in a few other areas, for example on
  testing, which is also expected to be agreed in
  2008
• A range of EU REACH technical support documents
  also exist and are being developed, notably the
  REACH Implementation Projects (RIPs) and the
  Technical Guidance Documents

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REACH

• What is my companys liability ?
• There is a general obligation to
• ensure that the manufacturing,
• placing on the market, importation
• or use of chemicals does not
• adversely affect human health
• or the environment
• Sanctions may be imposed for infringements of
  REACH, including this above-mentioned obligation

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REACH

• How much will it cost my company ?
• Scientific testing, data-compensation etc
• may prove costly, especially for substances
• that have little or no information background
• There will be fees to be paid for
• Registration and aspects related to it
• - this is expected to be finalised in 2008

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REACH

• What legal aspects need to be considered ?
• Scope - upstream or downstream, and,
  substances, or, preparations, or, articles
• Setting up consortia (contractual/corporate
  document) - data-sharing provisions, data-sharing
  compensation mechanisms, and, anti-trust
  provisions
• Data protection, confidentiality, and,
  intellectual property aspects
• Customs issues
• Possible appeals (The Board of Appeal, and, the
  European Court)?
• Use of access to information legislation
• Revision of supply agreements (obligations,
  liability etc)?
• Overall compliance strategy
• Insurance (policy)?

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REACH

• What other consequences might there be ?
• Environmental/health issues may come to the
  surface that have either lain dormant or which
  have been hitherto unknown
• Some substances will disappear from the market as
  REACH will be an expensive process
• Likewise, due to the cost of compliance with
  REACH, some businesses may be up for sale

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REACH

• The End
• Thank You For Your Attention
• André Bywater