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Compliance with REACH


Financial rules applicable to the agency (Article 99) ... Establishment of national helpdesks (Article 124) ... list to the COM by 1 December 2008 (Article 126) ... – PowerPoint PPT presentation

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Title: Compliance with REACH

Compliance with REACH Administrative burden or
chance for enhancing competitiveness J-C.
Lahaut European Voice Conference 4 December
The EU Chemicals Policy Review
  • In April 1998, the failure of the Existing
    Substances Regulation caused the European
    Environment Council to launch the Chemicals
    Policy Review (CPR)
  • The Council called on the Commission to develop
    a new, integrated and coherent chemicals policy
    adequately reflecting the precautionary principle
    and the principle of sustainability and
    specifying the obligations incumbent on the
    parties involved
  • Principles
  • Shift responsibility from authorities to
    industry, including downstream users
  • Enhance innovation
  • Substitute dangerous chemicals
  • Integrate the Precautionary Principle
  • Facilitate risk management decisions

Actors in the REACH process
  • Manufacturer/Importer
  • Should (pre)register substances Produced/Imported
    by him
  • Should do CSA/CSR for substance
  • RMM for intended use, extended SDS
  • Communicate down stream supply chain
  • Downstream User
  • Should communicate intended use to M/I
  • Should apply advised RMM
  • In case of non-identified use (gt1t/a) CSR and
    inform Agency
  • Formulator
  • Communicate up and down supply chain

Actors in the REACH process
  • Distributor
  • Downstream communication on Exp Scenarios and RMM
  • Upstream information on usage and identified use
    for registration
  • Consumer/user
  • Should follow advise SDS
  • Only representative
  • Importer may appoint only representative to
    fulfil his requirements
  • EU based
  • Third party representative
  • M/I appoint to represent in certain activities
  • To protect confidentiality and CBI

Pre-registartion Registration timetable for
phase - in substances
1 June 2007 REACH entries into force
1 Jun 2018
Pre-registration 18 months All substances
1 Jun 2008
1 Dec 2008
1 Jun 2013
1 Dec 2010
2,5 years
5 years
3,5 years
100 - 1000 t/y
1 - 100 t/y
11 years
3,5 years
6 years
Commission proposal Transitional Period
1 June 2015
1 Dec 2010
Issues to be decided by EU Institutions
  • Registration Testing methods for intrinsic
    properties (Art.13.3)
  • Substance evaluation development of criteria and
    priorities (Art. 47.2)
  • Fees structure and amount of fees for
    registration, authorisation and lodging of an
    appeal (Art. 74.1)
  • Agency recruitment of the key posts (Articles 75
    et seqq.)
  • Financial rules applicable to the agency (Article
  • Legal remedies procedures for the Board of
    Appeal (Article 93)
  • Access to information / confidentiality the
    Management Board adopts the practical
    arrangements for implementing Regulation
    1049/2001 including appeals or remedies against
    partial or full rejection of a confidentiality
    request by 1 June 2008 (Article 118.3)
  • Reporting obligations of the Agency 1 June 2011
    (Article 117)

Issues to be decided by the Member States
Issues to be decided by the Member States
  • Appointment of competent authority(ies) in the
    implementation of REACH and adequate funding
    (Article 121)
  • Establishment of national helpdesks (Article
  • Enforcement sanctions Laying down of the
    provisions on penalties applicable for
    infringement of the provisions of the REACH
    regulation and ensure their implementation.
    Notification of the list to the COM by 1 December
    2008 (Article 126)
  • Reporting obligations of Member States and the
    Agency 1 June 2010 (Article 117 and 127)
  • Invocation of the safeguard clause (Article 129)
    remains possible

RIPSIndustry engagement in RIPs is pivotal for
achieving practical guidance
  • Cefic is participating in the RIP projects of the
    Commission by
  • Representing industry positions in major parts
    of RIP 3
  • and RIP 4 via nominated representatives for
    the SEGs
  • (stakeholder expert groups).
  • Active participation in RIP 2 (REACH IT)
  • Leading role in consortium on RIP 3.2.2 task
  • (exposure scenario risk management measures
  • CSA/CSR)
  • Leading role in partnership on RIP 3.3.2
  • requirements endpoints)
  • Partner in tender for RIP 3.4 (data sharing)

FIRST STEP IN REACH Pre-Registration
Preparation for pre-registration and
registration- content
Inventory building information in the
supply chain Manufacturers/ Importers Downstre
am Users Distributors Pre-registration
How to prepare for REACH(1) ?Manufacturer /
  • Produce your company inventory of substances and
  • 2. Define for each substance/preparation your own
    status (M/I, distributor, DU, legal entity) and
    your position in the supply chain
  • 3. Determine if your company is the manufacturer,
    importer of the substance/preparation or
    purchased by your company from a supplier within
    the EU
  • 4. Determine if applicable
  • Non isolated intermediate
  • On-site isolated intermediate
  • Transported isolated intermediate
  • 5. For manufactured and /or imported polymers the
    monomers they are made from and the other
    constituents used for manufacturing of polymer

How to prepare for REACH (2) ?Manufacturer /
6. Establish the annual volume of manufactured or
imported substances and the composition of
preparations 7. Identify the CAS (and if
possible the EINICS or ELINCS) of manufactured or
imported substances 8. Identify and list your
customers per substance and per preparation
How to prepare for REACH (3) ?Manufacturer /
  • 9. Collect available information
  • Intrinsic properties
  • Animal testing results owned by company
  • CL
  • SDS
  • 10. Ensure there is clarity about the ownership
    of data
  • Arrange legal framework for use and ownership
  • 11. Establish which legal entity is involved as
    M/I for which substance/preparation

How to prepare for REACH (4) ?Manufacturer /
  • 12. Identify and list your suppliers per
    substance and preparation
  • 13. Compile readily available information on uses
    and conditions of use
  • List your customers
  • Own workplace and customers
  • Industrial, professional, consumer use
  • 14. Identify gaps of information
  • 15. Try to find out if your supplier will
    register for REACH- standard questionnaire is
    being prepared and will be circulated by Cefic
  • Example for template can be found at
  • http//
    ACH_TOOL_NL.xls - 3785.0KB

How to prepare for REACH ?Distributor
  • Inventarisation of substances that you distribute
  • Overview of your suppliers
  • Overview of your customers
  • Intensify contacts with suppliers and customers
  • Try to collect usage data
  • Check if your supplier will pre -registrer

SECOND STEP IN REACH Substance Information
Exchange Forum (SIEF) (for Phase in Substances)
SIEF for Phase-in Substances
  • SIEF Substance Info Exchange Forum
  • All potential registrants (M/I who have submitted
    the pre-registration information to the Agency
    for the same substance)
  • All downstream users and third parties who have
    submitted information to the Agency
  • Biocides and PPP notifiers whose information is
    held by the Agency
  • Registrants who have submitted a registration for
    that phase-in substance before 1 June 2018
  • Operational until 11 years after entry into force
  • Aim facilitate for the purpose of registration
    the exchange of information to minimise
    duplication of tests and to agree on
    classification and labelling
  • SIEF participants provide others with existing
    studies, react to requests by others, identify
    needs for further studies and arrange to carry
    them out.

The chemical industry and REACH
downstream users
national, sectoral federations
further DU
downstream users
Other interested persons (NGOs, academics)
opt-out registration
opt-out registration
lead registrant registration
How does REACH impact the business ?
How does REACH impact the business ?
  • The REACH Costs to calculate are a combination
  • Implementation costs for IT tools needed for
    making REACH work
  • IUCLID V system, ERP connections
  • The Phased REACH Compliance costs
  • Registration fees, lab costs
  • The Internal External resources needed
  • Information gathering, SIEF, consortia
  • Business related costs
  • REACH Implementation Legal entity structure,
    purchasing strategy
  • Product portfolio strategy marketing sales

How does REACH impact the business ?
  • Important potential cost saver for the
    Registration costs
  • is joining a consortium
  • Anticipated test costs (Annex VII X) with
    application of QSAR, read-across and waiving when
    working together in a consortium are significant
    lower !
  • (KPMG study, 2005. Based on REACH 2003 version)

Can you afford supplying a substance
  • Low margin products may not earn back the
    registration costs
  • Exceeding marginally tonnage thresholds may
    become too expensive as new data are required
  • Some applications can be identified as being
    borderline regarding safe handling ? additional
    testing worth the efforts?
  • Uses of your customers not covered by the
    registration ? loss of market shares / customers

Business perspectives of REACH
  • What is Cefic doing to support its members
  • How to best get prepared

Role of legal entities in the registration process
  • As registration is required per legal entity it
    is important to analyse the respective roles
    within a given supply chain

  • Same substance in two entities with individual
    supply to DU two reg.

Split of quantity with external supplier
  • Same substance in two entities but import via EU
    manufacturer one reg.
  • Needs carefull consideration of tonnage
    thresholds as aggregation of tonnage for both MI
    can exceed next level of data requirements!
  • How many seats in a SIEF to share the costs?

Purchasing strategy
  • Review the purchasing process per legal entity
    and see how it can be optimized
  • Purchased from the EU?
  • Imported by your company?
  • Do you know your business critical raw materials?
  • Use and conditions of use covered in registration
    of your supplier
  • Consider introduction of a lead buyer concept if
  • Lead buyer as main importer from outside the EU
  • Define role in the REACH process (M/I/DU)
  • Organize sufficient REACH Awareness to include in
    the Purchasing process, besides the focus on
    quality price, also on availability REACH

Marketing sales strategy
  • Do you cover the uses of your customers
  • Does your registration provide sufficient
    flexibility to cover new applications?
  • Organize the inclusion of Marketing Sales in
    the business evaluation decision making process
    to define the REACH Implementation strategy
  • Substitution pressure for your product?
  • Organize sufficient REACH Awareness in the sales
    after sales to better anticipate to the REACH
    needs of customers (safeguarding or creating new

Issues for the REACH Implementation strategy
  • REACH Implementation team, with stakeholders from
    EHS, IT, Purchasing, Marketing Sales?
  • REACH Working plan, with control over the REACH
    deadlines and necessary REACH Preparation
    projects to run?
  • Substance inventory and reviewed the business
    needs potential?
  • Cost efficient Registration strategy per
  • Cost analysis reviewed the potential cost saver
  • Communication strategy upstream down stream?

Is REACH to re-gain trust in our products ?
Is REACH to re-gain trust in our products ?
  • Principle of No data No market will force
    companies to register their substances, but
  • Pre-registration does not constitute any
    obligation to register
  • Registration deadlines for low volume substances
    are far away
  • Market forces may change timelines as
    formulators will need supply security
  • Retailers will ask for REACH-compliance when
    buying articles
  • NGO campaigns against hazardous substances
    (endocrines / PBTs) will not stop unless REACH
    assessment has been done.

REACH as a global competitive advantage ?
1. Statement REACH is according to COM
compliant with WTO rules ! 2. Statement REACH
will not be an isolated European solo but will be
copied in other countries 3. Statement
Risk assessment will become a day-to-day
effort for our industry
What happens in other parts of the globe ?
US Revision of TSCA is in the pipeline, some
states have a REACH-like system introduced (CA,
MA, MN) CAN Has indicated some interest in the
REACH system China Notification scheme for new
substances is similar to REACH. Old substances
not considered yet. International SAICM
process is introducing risk based approach in
chemicals management. Chemical industry (ICCA)
has developed GPS system with risk assessment
procedures to avoid legislative development
Is REACH triggering new businesses ?
  • No clear answer on this question !
  • Substances being produced in EU but only placed
    on the market outside the EU are still falling
    under REACH. This increases the costs! ? impact
    on int. competitiveness
  • Substances under authorization within the EU
    might still be on the non-EU market ? impact on
    int. competitiveness
  • Substitution can trigger innovative products, but
    may be beyond your own capabilities ? loosing
    market shares
  • Early movers to find substitutes may have a
    market advantage ? gaining market shares
  • Shake out in market may have loosers and winners
  • Non-EU competitors may transfer burden of
    registration to customers ? gaining market shares
    for EU producers
  • Increased transparency in the applications/markets
    ? inviting competitors

  • Conclusion

  • The administrative burden under REACH is high.
    Costs can be significant and may trigger
    deselection of products due to economic reasons.
  • There are opportunities to safe costs (grouping,
    consortia, strategic planning of REACH
  • Market effects can be manifold and can be turned
    into an advantage
  • Non-compliance with REACH is not an option as
    this would be equal with loss of licence to