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REACH

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REACH

REACH

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  • 1. Slide 1
    REACH
    An Introduction for the Non-EU Producers in the Softlines Industry
    (Textile, Clothing, Footwear)
    REACH Webinar
  • 2. About the presenter
    • Ms Connie Lau, REACH Officer, leads the REACH program for TÜV SÜD South China.
    • 3. Her role involves developing the range of REACH services to address the unique challenges faced by the client industries through close partnership with TÜV SÜD’s management system and chemical experts from the region.
    REACH Webinar
    Slide 2
    Contact information:
    Connie Lau
    REACH Officer
    TÜV SÜD Hong Kong
     : +852 2443 3774
     : ccchem@tuv-sud.hk
  • 4. What is REACH?
    REACH Webinar
    Slide 3
    What is REACH?
  • 5. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    • A single harmonised framework for chemicals management that amends and replaces 40 existing chemical legislations.
    • 6. It places the responsibility onto the manufacturers, importers as well as downstream usersto ensure the chemicals that are put on the EU market do not adversely affect human health or the environment.
    • 7. It aims to protect human health and the environment from the adverse effects of chemicals.
    • 8. Consumer products (articles) are also under control.
    Slide 4
    REACH Webinar
  • 9. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    Slide 5
    REACH Webinar
  • 10. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    Registration
    • Substances on their own
    • 11. Substances in mixtures
    • 12. Substances in articles in case of intended release
    Slide 6
    REACH Webinar
  • 13. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    Registration
    • Substances on their own
    • 14. Substances in mixtures
    • 15. Substances in articles in case of intended release
    Evaluation
    • Dossier evaluation
    • 16. Substance evaluation
    • 17. Testing proposal evaluation
    Slide 7
    REACH Webinar
  • 18. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    Registration
    • Substances on their own
    • 19. Substances in mixtures
    • 20. Substances in articles in case of intended release
    Authorisation
    Substances of Very High Concern (SVHC)
    • Candidate List
    • 21. Communication along supply chain
    • 22. Notification
    • 23. Annex XIV
    • 24. Authorisation
    Evaluation
    • Dossier evaluation
    • 25. Substance evaluation
    • 26. Testing proposal evaluation
    Slide 8
    REACH Webinar
  • 27. What is REACH?
    Regulation (EC) No 1907/2006
    REACH
    (the Registration, Evaluation, Authorisation and restriction of Chemicals)
    Registration
    • Substances on their own
    • 28. Substances in mixtures
    • 29. Substances in articles in case of intended release
    Authorisation
    Substances of Very High Concern (SVHC)
    • Candidate List
    • 30. Communication along supply chain
    • 31. Notification
    • 32. Annex XIV
    • 33. Authorisation
    Restriction
    • Hazardous chemicals
    • 34. General ban or product specific
    • 35. Prohibition or limitation
    • 36. From Dir. 76/769/EEC to REACH Annex XVII
    Evaluation
    • Dossier evaluation
    • 37. Substance evaluation
    • 38. Testing proposal evaluation
    Slide 9
    REACH Webinar
  • 39. Customs boundaries
    EU 27
    3 EEA
    Austria Germany Netherlands
    Belgium Greece Poland
    Bulgaria Hungary Portugal
    Cyprus Ireland Romania
    Czech Italy Slovakia
    Republic
    Denmark Latvia Slovenia
    Estonia Lithuania Spain
    Finland Luxembourg Sweden
    France Malta United Kingdom
    REACH Webinar
    Slide 10
    Iceland
    Liechtenstein
    Norway
    Switzerland
  • 40. Customs boundaries
    EU 27
    3 EEA
    Austria Germany Netherlands
    Belgium Greece Poland
    Bulgaria Hungary Portugal
    Cyprus Ireland Romania
    Czech Italy Slovakia
    Republic
    Denmark Latvia Slovenia
    Estonia Lithuania Spain
    Finland Luxembourg Sweden
    France Malta United Kingdom
    REACH Webinar
    Slide 11
    Iceland
    Liechtenstein
    Norway
    Switzerland
  • 41. Why does REACH concern me?
    REACH Webinar
    Slide 12
    Customs Borders
    Upstream
    Non-EU
    Substance Manufacturer
    Non-EU
    Mixture
    Formulator
    Non-EU
    Article
    Producer
    EU
    Importer
    EU
    Retailer
    EU
    Distributor
    Downstream
  • 42. Why does REACH concern me?
    Upstream
    Downstream
    REACH Webinar
    Slide 13
    Customs Borders
    Non-EU
    Substance Manufacturer
    Non-EU
    Mixture
    Formulator
    Non-EU
    Article
    Producer
    EU
    Importer
    EU
    Retailer
    EU
    Distributor
  • 43. Definitions
    REACH Webinar
    Slide 14
    Definitions
  • 44. Definitions
    Substance = Chemical
    Substance
    Substance
    in mixtures
    Substance
    in articles
    e.g. Washing powder
    e.g. Fabric
    e.g. Calcium chloride
    (A common household desiccant )
    Substance in articles intended to be released
    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
    e.g. Fabric with a microencapsulated chemical
    Slide 15
    REACH Webinar
  • 45. Intended Release

    Intended Release:

    NOT Intended Release:
    Slide 16
    REACH Webinar
  • 46. Intended Release

    Intended Release:

    An accessory function that:
    • is deliberately planned / wanted
    • 47. gives an ‘added value’
    • 48. occurs under normal or reasonably foreseeable conditions of use
    NOT Intended Release:
    Slide 17
    REACH Webinar
  • 49. Intended Release

    Intended Release:

    An accessory function that:
    • is deliberately planned / wanted
    • 50. gives an ‘added value’
    • 51. occurs under normal or reasonably foreseeable conditions of use
    NOT Intended Release:
    Substances that are released due to:
    • ageing, wear and tear or as an unavoidable side- effect of the functioning of the article
    • 52. accident or any form of misuse
    Slide 18
    REACH Webinar
  • 53. Packaging materials
    REACH Webinar
    Slide 19
  • 54. Registration
    REACH Webinar
    Slide 20
    Registration
  • 55. Registration Criteria
    Unless exempted,*
    • Substances
    • 56. Substances in mixtures
    • 57. Substances in articles intended to be released#
    That are imported into the EU at
    ≥ 1 tonne / substance / year / legal entity
    must be registered.
    *Exemptions are listed in Article 2, Annex IV, Annex V of REACH regulation.
    # Registration is not required for the substances if they have already been registered by any registrant (not necessarily from the same supply chain) for the same specific use.
    Slide 21
    REACH Webinar
  • 58. WHO is eligible to register?
    Customs Borders
    Upstream
    Non-EU
    Substance Manufacturer
    Non-EU
    Mixture
    Formulator
    Non-EU
    Article
    Producer
    EU
    Importer
    EU
    Retailer
    EU
    Distributor
    Downstream
    Slide 22
    REACH Webinar
  • 59. WHO is eligible to register?
    Customs Borders
    Upstream
    Non-EU
    Substance Manufacturer
    Non-EU
    Mixture
    Formulator
    Non-EU
    Article
    Producer
    EU
    Importer
    EU
    Retailer
    EU
    Distributor
    Downstream
    Registration must be carried out by an Only Representative (OR).
    Slide 23
    REACH Webinar
  • 60. WHEN to register?
    For registration purposes, chemicals are divided into 2 types:
    1
    2
    Phase-in (existing, EINECS):
    Non phase-in (new, ELINCS):
    Full registration from 1 June 2008.
    If pre-registered before 1 Dec 2008, then depending on hazards and tonnage:
    (Conditions apply for late pre-registration)
    Slide 24
    REACH Webinar
  • 63. Registration Deadlines
    Extended registration deadlines for pre-registered substances:
    Slide 25
    REACH Webinar
  • 64. LATE pre-registration
    Late pre-registration deadline and requirements
    after 1 December 2008
    • Import for the first time a phase-in substance; or
    • 65. Import for the first time an article containing a phase-in substance that would require registration
    at ≥ 1 tonne / substance / year / legal entity
    • Carried out within six months of first importing; and
    • 66. No later than 12 months before the relevant extended registration deadline
    Slide 26
    REACH Webinar
  • 67. Do I need to register?
    REACH Webinar
    Slide 27
    Registration is a very expensive and lengthy procedure.
    If you think registration may apply to your products, it is highly recommended that you speak with an Only Representative who can help you correctly identify your obligations and also provide advice on the best options for minimising costs.
  • 68. Restriction
    REACH Webinar
    Slide 28
    Restriction
  • 69. Restriction
    REACH Webinar
    Slide 29
    Up until 30 May 2009:
    Directive 76/769/EEC - restrictions on the marketing and use of certain dangerous substances and preparations.
  • 70. Restriction
    REACH Webinar
    Slide 30
    Up until 30 May 2009:
    Directive 76/769/EEC - restrictions on the marketing and use of certain dangerous substances and preparations.
    Since 1 June 2009:
    AnnexXVII of the REACH regulation. There have been 2 amendments so far:
    • Regulation (EC) 552/2009
    • 71. Perfluorooctanesulfonates (PFOS)
    • 72. 2-(2-methoxyethoxy)ethanol (DEGME)
    • 73. 2-(2-butoxyethoxy)ethanol (DEGBE)
    • 74. Methylenediphenyldiisocyanate (MDI)
    • 75. Cyclohexane
    • 76. Ammonium nitrate (AN)
    • 77. Regulation (EU) 276/2010
    • 78. Organostannic compounds
    • 79. Dichloromethane (DCM)
    • 80. Lamp oils and grill lighter fluids
  • “A substance on its own, in a mixture or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.”
    • Each restricted substance has its own limit
    • 81. A restricted substance found to be above limit may result in the product being
    • 82. rejected at customs
    • 83. withdrawn from the market
    • 84. recalled from consumers, resulting in brand damage
    • 85. Violation also subject to REACH penalties in the member state concerned
    Restriction
    Slide 31
    REACH Webinar
  • 86. Restriction
    Some current restrictions in Annex XVII related to softlines products:
    REACH Webinar
    Slide 32
  • 87. Restriction – Azocolourants & Azodyes
    • Textile and leather articles that may come into direct and prolonged contact with the human skin or oral cavity
    • 88. Limit: 30 mg/kg (30 ppm, 0.003%) in the finished articles or in the dyed parts.
    • 89. 22 aromatic amines
    • 90. Test methods standardised
    • 91. List of restricted azodyes provided
    Slide 33
    REACH Webinar
  • 92. Restriction – Nickel
    • Articles intended to come into direct and prolonged contact with the skin
    • 93. Limit: rate of release less than
    0.5 μg/cm2/week.
    • Applicable to garment parts such as: rivet buttons, tighteners, rivets, zippers and metal marks
    REACH Webinar
    Slide 34
  • 94. Restriction – phthalates
    • Childcarearticles and toys
    • 95. 2 groups of phthalates
    • 96. Limit: 0.1% by mass of the
    • 97. plasticisedmaterial
    • 98. Interpretation of 0.1%:
    • 99. sumof DEHP, DBP, BBP
    • 100. sumof DINP, DIDP, DNOP
    Slide 35
    REACH Webinar
  • 101. SVHC
    SVHC
    - Substances of very high concern
    Slide 36
    REACH Webinar
  • 102. SVHC
    What is a Substance of Very High Concern?
    Carcinogenic, Mutagenic or Toxic to Reproduction (CMR), category 1 or 2.
    Persistent, Bioaccumulative and Toxic (PBT) orvery Persistent and very Bioaccumulative (vPvB).
    Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters).
    Slide 37
    REACH Webinar
  • 103. SVHC
    Aim:
    To ensure substances of very high concern (SVHCs) are eventually replaced by less dangerous substances or technologies, where suitable economically and technically viable alternative are available.
    Procedure:
    • A “Candidate List” of SVHCs is drawn up
    • 104. SVHCs are prioritised from the Candidate List to be put on
    Annex XIV for authorisation
    • Use of an SVHC on Annex XIV will be prohibited after its
    “sunset date” unless authorisation has been granted for that use
    Slide 38
    REACH Webinar
  • 105. REACH Webinar
    Slide 39
    SVHC, Candidate List and Annex XIV
    ECHA Draft Recommendation,
    Public Consultation,
    Member State Committee Opinion
    Member State /
    European Commission Submission
    Candidate
    List
    (Communication)
    (Notification)
    Annex
    XIV
    (Authorisation)
    SVHC
    Public Consultation,
    Decision by Member State Committee or Commission
    ECHA Recommendation,
    EU Legislative Procedure
  • 106. SVHC – Obligation
    SVHC - Obligation
    Candidate List
    Communication along the supply chain
    Slide 40
    REACH Webinar
  • 107. The Candidate List
    At present, the Candidate List contains 38 SVHCs. These were announced on the following dates:
    REACH Webinar
    Slide 41
  • 108. REACH Webinar
    Slide 42
    The Candidate List
  • 109. REACH Webinar
    Slide 43
    The Candidate List
  • 110. REACH Webinar
    Slide 44
    The Candidate List
  • 111. The Candidate List – Communication Along the Supply Chain
    If an article contains any SVHC on the Candidate List at > 0.1% w/w
    Immediately inform the recipient of the SVHC information
    SVHC information:
    • the name of the SVHC
    • 112. instruction for the safe use of the product, if available
    Consumers have the right to request SVHC information on a product, and the following information must be provided within 45 days
    Note:
    • No specified methods on how this information must be communicated.
    • 113. Packaging materials are also defined as articles.
    Slide 45
    REACH Webinar
  • 114. Definition - 0.1% w/w
    Definition of 0.1% w/w:
    • An average SVHC concentration
    • 115. Seven dissenting countries:
    Austria, Belgium, Denmark, France, Germany, Norway and Sweden
    Total weight of an SVHC
    Total weight of the article
    x 100%
    Slide 46
    REACH Webinar
  • 116. Hazardous substances
    REACH Webinar
    Slide 47
  • 117. SVHC – Candidate list
    SVHC - Obligation
    Candidate List
    Notification
    Slide 48
    REACH Webinar
  • 118. Notification
    Notification to the ECHA applies only to articles that contain:
    1. An SVHC listed in the Candidate List at > 0.1% w/w, and
    2. Total quantity of this SVHC at > 1 tonne/year/legal entity
    unless
    3. Human and environmental exposure can be excluded during normal or reasonably foreseeable conditions of use including disposal, or
    4. The SVHC has already been registered for the specific use
    • If the ECHA suspects that the SVHC may present a risk to human health or the environment then a registration of the SVHC may be required.
    • 119. Notification requirement also applies to packaging materials.
    REACH Webinar
    Slide 49
  • 120. Notification
    Information to be submitted for a notification:
    • Identity and contact details of the importer
    • 121. Registration number, if available
    • 122. Identification and classification of the SVHC
    • 123. A brief description of the use(s) of the SVHC(s) in the article and the uses of the article(s)
    • 124. The tonnage range of the SVHC(s)
    e.g. 1 – 10 tonnes, 10 – 100 tonnes, etc.
    REACH Webinar
    Slide 50
  • 125. Notification
    REACH Webinar
    Slide 51
    Notification begins on 1 June 2011.
    A new substance in the Candidate List must be notified to the ECHA within 6 months of its first listing. This means:
    • for substances included in the Candidate List before 1 December 2010, the notifications have to be submitted no later than 1 June 2011.
    • 126. for substances included in the Candidate List on or after 1 December 2010, the notifications have to be submitted no later than 6 months after the inclusion.
  • SVHC – Obligation
    SVHC - Obligation
    Annex XIV
    Authorisation
    Slide 52
    REACH Webinar
  • 127. Authorisation
    Authorisation began on 1 June 2009.
    The use of an SVHC on Annex XIV will be prohibited after its “sunset date” unless authorisation has been granted for that use.
    • 1 June 2009: the ECHA submitted the recommendation on 7 SVHCs to the European Commission for voting into the legislation.
    • 128. 1 July 2010: a 3-month public consultation began for the 2nd recommendation, which contains 8 SVHCs.
    • 129. The ECHA shall make further recommendations at least once every 2 years.
    REACH Webinar
    Slide 53
  • 130. Authorisation – Annex XIV
    REACH Webinar
    Slide 54
  • 131. Authorisation
    REACH Webinar
    Slide 55
    Although authorisation does not apply to imported articles, it may still be of commercial interest to a non-EU producer of softlines products to be aware of the development of SVHCs on Annex XIV.
  • 132. Relevant URLs
    The European Chemicals Agency (ECHA)
    http://echa.europa.eu/home_en.asp
    Member State national helpdesks
    http://echa.europa.eu/help/nationalhelp_contact_en.asp
    Candidate List
    http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp
    Annex XIV
    http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_rec_en.asp
    Guidance Documents
    http://guidance.echa.europa.eu/guidance_en.htm
    REACH Webinar
    Slide 56
  • 133. Thank you!
    Slide 57
    REACH Webinar
    This information provided herein is of a general nature and is not intended as professional advice services. TÜV SÜD makes no warranties or representations, expressed or implied, as to the accuracy or completeness of the information provided herein.
    If you are seeking advice on any matters relating to information provided herein, you should – where appropriate – contact us directly with your specific query or seek advice from qualified professional people.
     
    The information contained herein may not be copied, quoted or referred to in any other publication or materials without the prior written consent of TÜV SÜD. All rights reserved © 2009 TÜV SÜD Asia Pacific Pte. Ltd.