This document provides an introduction to REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) for non-EU producers in the softlines industry. It begins with information about the presenter and contact details. It then defines REACH as the EU chemicals regulation that aims to protect human health and the environment from risks of chemicals. Key REACH processes like registration, evaluation, authorisation and restriction are summarized. The document provides an overview of REACH obligations and requirements for non-EU companies that manufacture, formulate or produce articles containing chemicals that are imported into the EU.

1. Slide 1 REACH An Introduction for the Non-EU Producers in the Softlines Industry (Textile, Clothing, Footwear) REACH Webinar

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?

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

11. Substances in mixtures

12. Substances in articles in case of intended release Slide 6 REACH Webinar

14. Substances in mixtures

16. Substance evaluation

17. Testing proposal evaluation Slide 7 REACH Webinar

19. Substances in mixtures

21. Communication along supply chain

22. Notification

23. Annex XIV

25. Substance evaluation

26. Testing proposal evaluation Slide 8 REACH Webinar

28. Substances in mixtures

30. Communication along supply chain

31. Notification

32. Annex XIV

34. General ban or product specific

35. Prohibition or limitation

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

47. gives an ‘added value’

48. occurs under normal or reasonably foreseeable conditions of useNOT Intended Release: Slide 17 REACH Webinar

50. gives an ‘added value’

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

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

61. 31 May 2013

62. 31 May 2018(Conditions apply for late pre-registration) Slide 24 REACH Webinar

63. Registration Deadlines Extended registration deadlines for pre-registered substances: Slide 25 REACH Webinar

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.

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)

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 concernedRestriction Slide 31 REACH Webinar

86. Restriction Some current restrictions in Annex XVII related to softlines products: REACH Webinar Slide 32

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

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

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

113. Packaging materials are also defined as articles. Slide 45 REACH Webinar

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

119. Notification requirement also applies to packaging materials.REACH Webinar Slide 49

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

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.