Webinar: Complying with the New European Union Chemical Legislation

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Webinar Complying with the New European Union
Chemical Legislation
Ursula SchliessnerMcKenna Long Aldridge LLP,
Brusselswww.mckennalong.com
November 6, 2008 at 12 noon (Eastern Time)
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• Introduction

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(No Transcript)
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Registration

• Obligation of each manufacturer/importer
• Substances, on their own or in preparations or if
  released from articles
• 1 tonne threshold (per manufacturer/ importer)
• Provide data
• No registration/data, no market

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Exemptions and Exclusions

• Exclusions from REACH
• Radioactives within Directive 96/29
• Non-isolated intermediates
• Waste as defined in Directive 2006/12
• Defense (to be determined by Member States)
• GMOs

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Exemptions and Exclusions (contd)

• Exemptions from Registration
• Substances notified under existing new
  substances legislation
• Below 1 tonne per year per manufacturer/importer
• Substances in medicinal products
• Substances in food or feed incl. additives,
  flavorings
• Annex IV substances (e.g. cellulose pulp)
• Annex V substances

Attention Revised Annexes IV and V published OJ
L 268 of 2008 Reg 987/2008
Also exempt from downstream user requirements,
evaluation and authorization Also exempt from
downstream user requirements and evaluation
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Exemptions and Exclusions (contd)

• Exemptions from Registration
• Recovered substances similar to registered
  substances
• Polymers
• PPORD for 5 years, but subject to notification
• Actives (and co-formulants) under Directive
  91/414 and actives under Directive 98/8 if listed
• Reduced registration for on-site isolated or
  transported isolated intermediates

Also exempt from evaluation
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• Pre-Registrationand Registration Issues

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Phase-In Substances

• A substance is a phase-in substance if it meets
  one of the following criteria
• EINECS listed or
• Over 15 years preceding the entry into force of
  REACH, manufactured in the EU but not marketed by
  manufacturer/importer or

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Phase-In Substances (contd)

• Deferred Registration for Phase-In Substances
• December 2010
• CMRs Category 1 and 2
• R 50/53 (very toxic to aquatic organisms) gt100
  tonnes/year and
• gt1000 tonnes per year
• June 2013 gt100 tonnes/year
• June 2018 gt1 tonne/year

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Pre-Registration

• Applies to phase-in substances
• Timing 6 month window
• 1 June 08 1 December 08
• Failure to pre-register results in loss of
  phase-in status
• Attention takes about 10 minutes online, but
  recently IT problems. Do not wait until last
  moment.

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Pre-Registration (contd)

• Data Requirements
• Name of substance, plus EINECS/CAS numbers
• Identification of registrant
• Manufacturer/Importer
• Contact (could be Third Party Representative)
• Registration deadline (tonnage band)
• (read-across)
• (volunteer facilitator)

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Pre-Registration (contd)

• Additional Rules
• Agency to publish list of pre-registered
  substances
• By name and by EINECS and CAS numbers
• Attention ECHA has already published publicly
  available pre-List (substance names)
  http//apps.echa.europa.eu/preregistered/pre-regis
  tered-sub.aspx
• Downstream user of a substance not on the list
  may notify the Agency
• Agency to publish DU name

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Pre-Registration (contd)

• Additional Rules (contd)
• Late market entrants can obtain phase-in status
  if they submit required information
• Within 6 months after crossing 1 tonne threshold
• No later than 12 months before applicable
  registration deadline (3.5, 6, or 11 years)

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Pre-Registration (contd)

• Once pre-registration requirements fulfilled, no
  further registration obligations for
• 3.5 years
• 6 years
• 11 years
• BUT
• Possible testing complications and
• Beware the SVHCs

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Pre-Registration (contd)

• Recent Issues with Pre-Registrations ECHA press
  release October 6, 2008
• ECHA consider that those exemptions that are
  available for substances registered are not
  available if the substances have just been
  pre-registered.
• Nevertheless, ECHA recommends, following
  discussion with the European Commission services,
  that for certain types of substances, such as
  re-imported substances (Article 2.7c), recovered
  substances (Article 2.7d), monomers in polymers
  (Article 6.3), and substances intended to be
  released from articles (Article 7.6) companies
  should pre-register if they are not sure that the
  substance(s) concerned will be registered by 1st
  December 2008, the end of the pre-registration
  period.

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SUBSTANCE INFORMATION EXCHANGE FORA (SIEF)

• Concept
• All pre-registrants of the same substance become
  members of a Substance Information Exchange Forum
  for that substance
• Attention SIEFs seem far bigger than expected
  because of many just-in-case pre-registrations

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SIEF (contd)

• Goals
• Facilitate Registration
• Facilitate exchange of information
• Avoid duplication of studies
• Identify and agree on needs for further studies
• Resolve differences on classification and
  labelling

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SIEF Functioning

• By January 09, Agency to publish list of
  pre-registered substances on its website (no
  company names)
• Around the same time, Agency is expected to
  inform all pre-registrants of the same substance
  of the identity of the other companies
• Once all participants agree on substance
  identity, SIEF is actually formed and data
  sharing can start
• Attention Lots of pre-SIEF discussions already
  on-going. Do not participate in such discussions
  without at least agreement on confidentiality and
  undertaking to abide by EU competition law
  principles (Art. 81, 82 ECT)
• Upon publication of list of pre-registered
  substances on Agencys website, other parties may
  seek to participate in certain SIEF activities
• Companies manufacturing/importing below 1 tonne
• Downstream users
• Third parties holding information on substances

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Exchange of data within SIEF

• Mandatory within a SIEF
• Missing vertebrate animal data must be queried
• Testing VA cannot be undertaken without querying
  first
• Other data may be queried
• Answering queries is always obligatory
• Exchange of data is optional between different
  SIEFs (read across)
• Cost sharing
• either agree on non discriminatory, fair and
  equitable cost sharing, or
• equal sharing

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Only Representative

• OR can be appointed by non-EU
• Manufacturer of substances
• Formulator of preparations
• Producer of articles
• OR takes on registration and other REACH
  responsibilities
• OR will be fully liable as importer

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Only Representative (contd)

• Why use an OR?
• Solve customer as importer problem
• Solve CBI problem

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Special Issues for Non-EU Companies
Issue 1 Options for (Pre-)Registration
Canada Manufacturers - OR - EU Subsidiary -
EU customer acts as importer Points to
consider - Confidentiality - Registration
cost - Flexibility
EU Customer
EU Customer
EU Customer
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Special Issues for Non-EU Companies (contd)
Issue 2 Number of OR

• European Commission has issued guidance that only
  one OR per substance per manufacturer is possible
  for full volume of EU imports. Attention Rumors
  will that this policy may still change

Issue 3 Multiple Representation
EU Customer

• If OR represents multiple companies with same
  substance, one registration for each manufacturer
  represented has to be filed

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Unsolved Issues

• Definition of non-EU manufacturer
• Similar to EU manufacturer or not?
• Use of EU branch office of Canadian company
  instead of OR? Legal entity concept is left to
  national law
• Definition of REACH importer not similar to
  importer for customs purposes. Therefore
  potentially possible to contractually determine
  REACH importer thereby avoiding OR engagement

EU Customer
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Articles

• Articles are manufactured products for which
  shape or design is more important than the
  chemical composition, e.g. micro processors
• Importers of articles must
• register substances intentionally released during
  normal and reasonably foreseeable handling and
  use conditions and present in articles above 1
  ton/year, and
• notify SVHCs contained in articles above 0.1 w/w
  and substances present in articles above 1
  ton/year
• Main issues
• lack of knowledge on the presence of SVHCs in
  imported articles (SVHCs are likely to be in the
  thousands)
• difficulties in tracing long supply chains (see
  experience with RoHS)
• (legal and practical) uncertainties (many
  unresolved borderline cases)

EU Customer
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Substances in Articles Timing

• The same registration deadlines as for all other
  substances
• 3.5, 6 and 11 years for phase-in
• 1 year for non phase-in
• Notification applies as of 48 months after entry
  into force (June 2011) and 6 months after new
  substances are included in the candidate list
• Most CMRs and R50/53 above 100 tonnes will be
  registered by December 2010, hence no
  notification if registration covers use in article

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Substances in Articles Information in the
Supply Chain

• Suppliers of articles containing SVHCs (listed in
  candidate lists) must provide sufficient
  information allowing safe use of the article
  (including, at a minimum, name of the substance)
• to recipients of articles
• to consumers
• Information must be provided within 45 days of
  receipt of request
• Attention Applicable as of October 28, 2008 to
  substances on first candidate list

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Annex 1 The Candidate List
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Substances in Articles

• Canada vs. EU Article Manufacturer
• EU-based manufacturer purchases substance from
  its supplier
• Supplier registers substance customer exempt
• Canada-based manufacturer purchases substance
  from its supplier
• Supplier not in EU
• Substance introduced into EU by article
  manufacturer
• Customer of article manufacturer must register
  the substance

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Substances in Articles (contd)

• Exemptions
• Neither Registration nor Notification required if
  a substance has already been registered for that
  use
• Customer of Canada article manufacturer not
  exempt
• Unless another EU M/I of same substance registers
  (for that use)
• If notifier can exclude substance exposure to
  humans and the environment during the normal or
  reasonably foreseeable conditions of use
  (including disposal)

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Substances of VeryHigh Concern (SVHCs)

• See Authorization, Article 57
• Category 1 and 2 Carcinogens (C)
• Category 1 and 2 Mutagens (M)
• Category 1 and 2 Reproductive Toxicants (R)
• Persistent, Bioaccumulative, Toxic (PBT)
• Very Persistent, Very Bioaccumulative (vPvB)
• Substances with Equivalent Concerns
• e.g., Endocrine Disruptors

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Authorization

• SVHCs will be
• Identified (candidate list)
• Listed on Annex XIV
• Subject to Authorization
• Small volume SVHCs (i.e., lt 1 Tonne/Year)
• May be placed on Annex XIV
• Small volumes uses must then be authorized

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Authorization (contd)

• Substances placed on Annex XIV
• If on Annex XIV, substance may not be placed on
  the market after sunset date
• By a manufacturer, importer or downstream user
• Unless specific use authorization provided
• Application gt 18 months before sunset date

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Consortia do not necessarily strictly mirror
SIEFs

• They can be formed before pre-registration
• They can cover more than one substance and
  consequently more than one SIEF
• They may not include all potential registrants
• There can be more than one consortium within one
  single SIEF (differences in substance identity,
  different uses, e.g.)

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Consortium formation

• Contract between interested parties (operating
  rules)
• Contractual freedom but there are limitations
• EU competition law
• Confidentiality must be ensured 
• REACH Regulation provisions
• Historically, consortium usually created as a
  task force
• No legal personality
• Flexible, limited in time and scope

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Consortia Issues

• Late membership/data compensation
• entry fee (to cover set up and administrative
  costs)
• cost of the data (actual vs. current cost)
• risk premium to compensate founding members for
  higher risks in data development
• investment premium to compensate founding
  members for lack of return on funds used for data
  development
• interest adjustment on all payments

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Consortia - Update

• Many consortia have been formed already or are in
  the process of being formed. For unofficial
  list, see
• http//chemicalwatch.com/REACH_consortia