Webinar: Complying with the New European Union Chemical Legislation - PowerPoint PPT Presentation

1 / 38
About This Presentation

Webinar: Complying with the New European Union Chemical Legislation


Ursula Schliessner McKenna Long & Aldridge LLP, Brussels www.mckennalong.com November 6, 2008 at 12 noon (Eastern Time) Introduction Registration Obligation of each ... – PowerPoint PPT presentation

Number of Views:83
Avg rating:3.0/5.0
Slides: 39
Provided by: tradecommi8


Transcript and Presenter's Notes

Title: Webinar: Complying with the New European Union Chemical Legislation

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

(No Transcript)
  • 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

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

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,
  • 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
Exemptions and Exclusions (contd)
  • Exemptions from Registration
  • Recovered substances similar to registered
  • 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
  • Pre-Registrationand Registration Issues

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

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

  • 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

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)

Pre-Registration (contd)
  • Additional Rules
  • Agency to publish list of pre-registered
  • By name and by EINECS and CAS numbers
  • Attention ECHA has already published publicly
    available pre-List (substance names)
  • Downstream user of a substance not on the list
    may notify the Agency
  • Agency to publish DU name

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)

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

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
  • 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

  • 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

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

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

Exchange of data within SIEF
  • Mandatory within a SIEF
  • Missing vertebrate animal data must be queried
  • Testing VA cannot be undertaken without querying
  • 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

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
  • OR will be fully liable as importer

Only Representative (contd)
  • Why use an OR?
  • Solve customer as importer problem
  • Solve CBI problem

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
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

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
  • 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
  • Main issues
  • lack of knowledge on the presence of SVHCs in
    imported articles (SVHCs are likely to be in the
  • difficulties in tracing long supply chains (see
    experience with RoHS)
  • (legal and practical) uncertainties (many
    unresolved borderline cases)

EU Customer
Substances in Articles Timing
  • The same registration deadlines as for all other
  • 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

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

Annex 1 The Candidate List
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
  • Customer of article manufacturer must register
    the substance

Substances in Articles (contd)
  • Exemptions
  • Neither Registration nor Notification required if
    a substance has already been registered for that
  • Customer of Canada article manufacturer not
  • 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)

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

  • 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

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

Consortia do not necessarily strictly mirror
  • 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.)

Consortium formation
  • Contract between interested parties (operating
  • 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

Consortia Issues
  • Late membership/data compensation
  • entry fee (to cover set up and administrative
  • 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
  • interest adjustment on all payments

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
Write a Comment
User Comments (0)
About PowerShow.com