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Intertek REACH Presentation, 2008 1

Content REACH in Details (am / pm) REACH Introduction Registration Requirements for SVHC Evaluation, Authorisation and Restriction Timeline Summary 2

Content Suggestions to Toys Industry (pm) ( ) Discussion on Vendors Roles and Possible Actions Discussion on Jakks Pacific Products Jakks Pacific Jakks Pacific s timeline for vendors Jakks Pacific Intertek IT system and technical support Intertek IT Questions and Answers Assessment 3

Real life issues Chromium VI Cadmium Lead Mercury PBBs PBDEs = Erin Brockovich: CrVI in water supply : 6 6

Why new EU chemicals policy needed? Tested 3% No Data 21% Minimum data (base set) 11% Availability of test data of high volume chemicals Very little data (less than base set) 65% 7

Overview REACH is a new System Regulation for Chemical Substances REACH Enter into force on 1-Jun-2007 2007 6 1 Focus on: High volumes chemicals Substances of very high concern (SVHC) SVHC Industries take responsibilities (Duty of care) 8

Why REACH concern my industry? REACH Chemicals are present and being used everywhere 9

Key Elements 1 / Registration of substances > 1 tonne/year Increase information and communication throughout supply chain Evaluation of some registered substances Authorisation of substances of high concern Restrictions of unacceptable substances (ECHA) Chemical Agency to manage the system 10

(Scope) ( ) Apply to the manufacture, placing on the market (including import) or use of chemical substances on their own, in preparations or in articles 11

Article Preparation Toys with main functions decided by shape and design instead of chemical composition Mixture paint Substances Individual pigments, solvents, etc. 12

Requirements of Registration Legally required for European Manufacturers and Importers, who Make or introduce substances (include substances in preparation), In quantity 1 tonne/year 14

Requirements of Registration Legally required for European Manufacturers and importers, who Make or introduce Substances intended to be released from articles under normal and reasonably foreseeable conditions of use, In quantity > 1 tonne/year 15

Exercises What are preparations? What are articles? What are substances intended to be released under normal and reasonably foreseeable conditions of use? 16

Are these preparation vs article? A bottle of perfume A liquid in glass thermometer Car perfume A crayon A roll of adhesive tape Compressed air-freshener spray A LR6 (AA) battery A pack of desiccant 17

Rules of being an preparation If substance / preparation removed, can object still fulfill its intended purpose? Does object act as a container or carrier for release? Is chemical content consumed during use and separated from object before disposal? 18

Rules of being an article If substance/preparation removed, is object unable to fulfill its intended purpose? Main purpose of object not to deliver a substance/preparation? / Object normally discarded together with substance/preparation? / 19

Article 20

Are substances intended to be released? A liquid in glass thermometer A roll of adhesive tape A LR6 (AA) battery A scented eraser Car tyres Pot pourri Jean with fade out dye 22

Rules for intended release Release contributes an accessory function (or added value) of the article? NOT intended release if Release during use Release caused by unavoidable side effects Release formed by chemical reactions Release is incidental 23

Time Frame Phase-in Substances 2008 ( ( ) Pre-registration from 2008.6.1 to 2008.12.1 Complete Registration by 2010 2013 2010.11.30 (3.5 年内 ) for CMR Cat.1&2; & 1 t/y (CMR 1 2 ) Very toxic to aquatic organisms & 100 t/a ( ) 1000 2013.5.31 (6 年内 ) for 2018 2018.5.31 (11 年内 ) for 24

Pre-registration To continue business after 1 st December 2008, you must pre-register from 1 st June 2008 to 1 st December 2008 25

Importance for Pre-registration Registrants who do not pre-register shall not be able to rely on the registration grace periods (i.e. 3½, 6 and 11 years) 3.5 6 11 Information required: Identity of the substance Name and address of the contact person The tonnage band and deadline 26

Substance Information Exchange Forum ECHA publish list of pre-registered substances against registrants in Dec-2008 ECHA 2008 12 Registrants participate in Substance Information Exchange Forum (SIEF) Data and cost sharing between registrants Enough time to proceed registration Data submission by a lead registrant 27

Registration Process = Submission of documents Technical Dossier : start at 1 tonne/year : 1 / Collection of chemical properties, including toxicity data Chemical Safety Report : start at 10 tonnes/year : 10 / Assessment of safety 评 Possibly involves huge money (depending on tonnage) 28

Relevant studies required per year 年 1 10 100 1000 Annex VII VII + VIII VII + VIII + IX VII + VIII + IX + X Higher the quantities per year, the more Annexes apply Only proposals for tests in Annexes IX and X IX X 29

Study information summary Physicochemical 理 physical properties 理 chemical properties Toxicological 理 in vitro studies bacteria and/or mammalian cells / vertebrate animals Ecotoxicological 态理 on algae, plant, Daphnia (water fleas), fish, earthworm, birds 30

Fees and Charges Proposed standard fees for individual registration: 1-10 tonnes: free (exceptions apply) 1-10 10-100 tonnes: 4,300 10-100 4,300 100-1000 tonnes: 11,500 100-1000 11,500 1000 tonnes above: 31,000 1000 31,000 Reduced Fees for SMEs: 30 90% discount 30 90% Further 25% discount for joint submission 25% 31

SDS required for preparations SDS Suppliers SDS Jakks Pacific 32

Content of Safety Data Sheet 1. / / Identification of the substance / preparation, and company 2. Hazards identification 3. / Composition / Information of ingredients 4. First-aid measures 5. Fire-fighting measures 6. Accidental release measures 7. Handling and storage 8. / Exposure controls/ personal protection 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information 12. Ecological information 13. Disposal consideration 14. Transport information 15. Regulatory information 16. Other information 33

FAQ 34

Question #1 How to handle chemically similar, but commercially different products, e.g. perfume in candle and pot pourri? Answer #1 REACH requires registration for each substance REACH Products understood as preparations (= mix of substances) do not have to be registered only the individual substances 35

Question #2 How can non-eu manufacturers register? Answer #2 Appoint an only representative Natural or legal person in EU Have sufficient background Comply with all obligations of importers Importer Downstream User 36

Question #3 When importing same preparation with a substance from different manufacturers in different non-eu countries, is it necessary to conduct repetitive registrations? Answer #3 No, just register per substance being imported if substance IDs are identical Submitted information based on final volume of the importer, that is sum up volume of individual manufacturers 37

Question #4 Does a plastic require registration? Answer #4 Plastic is a preparation, but polymer is exempted Monomer > 2% and 1 tonne/year will require registration > 2% 1 / 38

Definition Substance of Very High Concern (SVHC) CMR: Carcinogenic, mutagenic and toxic for reproduction,, PBT : Persistent, Bioaccumulative and Toxic vpvb: very Persistent and very Bioaccumulative substances Similar substances, e.g. endocrine disrupter 40

Article 33 33 Dolls, Electronic Toys, Infant & Preschool, Creative Play, etc. Apply to ALL articles If SVHC presents >0.1% SVHC > 0.1% Inform customers minimum Chemical Name Information on safe use Consumers may request information about presence of SVHC in articles (must reply within 45 days) SVHC 45 41

Sample Letter Suggested by NGO Date Dear Sir/Madam In accordance with the new European regulation on Chemicals, REACH, I am writing to ask you to inform me about the presence in the product XX or its packaging of any chemical from the group of "substances of very high concern" as specified by REACH. Should any of these substances be present in the product XX or its packaging, I wish to be informed about the name of this substance, and receive sufficient information on how I can protect myself and the environment from it. I would be grateful to receive this information within 45 days as required by REACH. I would be grateful if you would inform me about steps you are talking to provide products intended for the same use but which do not contain such potentially hazardous chemicals. Yours faithfully, cc: European Chemicals Agency - P.O. Box 400, 00120 Helsinki, Finland, phone: +358-9-686180 e-mail: info@echa.europa.eu, www.echa.europa.eu 42

Notification for Articles If SVHC present in Article > 0.1% & amount of SVHC > 1 tonne/year, Notification is required. >0.1% > Time frame: from 1-Jun-2011 2011.6.1 Volume is sum up of all products 43

Don t forget your packaging! Packaging materials are articles! 44

SVHC Presence in these Materials? SVHC? Plastic materials: PVC, PU : Leather Textiles Metal parts Wooden parts Paint, print and glue Paper board Electronic components / PCB PCB 45

Possible SVHC in Leather Tanning chemicals, e.g. chromium sulfate Chromium VI Fat liquor in leather treatment, e.g. Chlorinated paraffins Biocides, e.g. Tributyltin Azo dyes, e.g. (reduction) Benzidine 46

Possible SVHC in Textiles Materials Dyestuffs, e.g. C.I. Basic Black 38 C.I. Direct Blue 6 C.I. Direct Brown 95 C.I. Direct Red 28 C.I. Disperse Blue 1 C.I. Oxidation Base 12 C.I. Oxidation Base 35 47

Possible SVHC in Textiles Materials Flame retardants, e.g. Tri-o-cresyl phosphate Dyeing carriers, e.g. 1,2,4-trichlorobenzene Softener in print, e.g. (diethylhexyl)phthalate 48

Possible SVHC in Plastics / Electronics / SVHC Plasticisers, e.g. DEHP, DBP Flame retardants, e.g. Penta-BDE, Octa-BDE Hexabromocyclododecane Hexachlorocyclopentadiene 49

Possible SVHC in Plastics / Electronics / SVHC Pigments in plastics, e.g. C.I. Pigment Black 25 25 C.I. Pigment Red 104 C.I. Pigment Yellow 157 C.I. Pigment Yellow 34 C.I. Solvent Yellow 1 1 C.I. Solvent Yellow 3 3 Stabilisers, e.g. Cadmium, tributyltin 50

Possible SVHC in Metal Accessories SVHC Lead (alloy) Nickel (plating) Cadmium (plating) 51

What Chemicals > 0.1%? 0.1% Dyestuffs Flame retardant coating (up to 20% product weight) Dyeing accelerators (carriers) (up to > 1%) Softener in print 52

FAQ 53

When will Article 33 be in force? 33 Question #1 问题 #1 Answer #1 1 Already in force, but Official SVHC list has not yet been published 54

Question #2 问题 2 When will the SVHC list be published? SVHC Answer #2 2 Expected end of 2008 or early 2009 2008 2009 A live list Affect products already in market 55

How many SVHC are there?? Question #3 问题 3 Answer #3 3 Now known: ~900 CMR; 700-1100 PBT/vPvB ~900 CMR; 700-1100 PBT/vPvB Expected addition: ~600 : ~600 Total: 1,500 : 1,500 56

Question #4 问题 4 What can manufacturers and suppliers do to comply with Article 33? 33 First step training Answer #4 4 Second step collect chemical information Third step check against SVHC list & calculate % of SVHC SVHC SVHC 57

How to collect information from non-eu suppliers? Information is requested for specific articles produced Information is requested in a standardized form (e.g. questionnaire, ingredient tables) from all actors up the supply chain. Excluding the use of substances. For example, suppliers provide certificates that substances are not used or remain under certain concentrations in articles 58

Intertek REACH Presentation, 2008 59

Example of Ingredient Table Plastic 60

Example of Ingredient Table Dye 61

Example of Ingredient Table Fabric 62

Example of Ingredient Table PCB PCB 63

Example of Ingredient Table Transistor 64

Example of Ingredient Table Button Cell 65

Example of Ingredient Table Metal Parts 66

Example of Ingredient Table Metal / plating 67

Evaluation Provide confidence that industry is meeting obligations. Prevent unnecessary testing Dossier Evaluation Substance Evaluation Check test proposal Compliance Examine any information on a substance Require further information? Identification of Dangerous Substances (including SVHC) SVHC 69

Authorisation Ensure risks from SVHC are properly controlled or substituted SVHC SVHC only, ~1500 substances SVHC ~1500 Authorisation charge: ~ 50,000 50,000 Applicant to show: Adequate control of risks, or Social and economic benefits outweigh the risks (no substitution) ( ) Applicant requires to analyse alternatives Periodic review/analysis of alternatives Chemicals of High Concern Safe use Substance authorised under adequate controls Substitute Use substitute No safe use or no threshold limit Benefits Substance authorised when benefits outweigh risks No substitute No benefits No authorisation 70

Restriction Safety net risks not adequately controlled Substances, preparations and articles for which Annex XVII contains a restriction Copy from 76/769/EEC and including 76/769/EEC PCP Directive 1999/51/EC Cadmium Directive 91/338/EEC Nickel Release Directive 94/27/EC Azocolorants Directive 2003/3/EC Phthalates Directive 2005/84/EC 71

Preparation Products REACH Requirements REACH Article Substance intended to be released?? Registration (> 1 t/y) Yes Registration (> 1 t/y) (> 1 / ) Information to recipient (SVHC > 0.1%) ( > 0.1%) No Notification (SVHC>1 t/y) ( >1 / ) Information to recipient (SVHC > 0.1%) ( > 0.1%) 73

Timeline Summary Jun-2007 Early-2008 1-Jun to 1-Dec1 2008 Dec-2008 Jun-2011 1-June-2007 Early 2008 1-June-2008 1-Dec-2008 Dec-2008 1-June-2011 : REACH comes into force : Clarification on articles : Pre-Registration starts : Pre-Registration ends : First SVHC list published, then Inform client if SVHC > 0.1% SVHC SVHC > 0.1% Shipment stops if not pre-registered : Notification comes into force 74

Roles & Obligations Chemical Supplier Material Supplier Non-EU Article Manufacturer Retailer dyes, print plastic, metal toys, garments (usually importer) (always importer) Pass Pass Chemical Chemical Information Information Collect Collect Chemical Chemical Information Information Collect Collect Chemical Chemical Information Information Pre-register Pre-register as as required required Pre-register Pre-register as as required required Provide Provide MSDS MSDS Pass Pass Chemical Chemical Information Information Pass Pass chemical chemical Information Information Collect Collect / Advise / Advise Presence Presence of of SVHC SVHC Collect Collect / Advise / Advise Presence Presence of of SVHC SVHC Check Check Presence Presence of of SVHC SVHC Pre-register Pre-register as as per per request request Collect Collect MSDS MSDS for for Preparation Preparation Collect Collect MSDS MSDS for for Preparation Preparation SVHC SVHC Calculate Calculate for for Notification Notification Calculate Calculate for for Notification Notification Demonstrate Demonstrate Due Due Diligence Diligence Demonstrate Demonstrate Due Due Diligence Diligence 76

应料应零传 MSDS MSDS / / 度关度关质 / / 检度关度关质 MSDS MSDS MSDS MSDS 报计报计 77

Actions for : Vendors Staff education Collect chemical information (including packaging) ( ) Collect MSDS for preparation MSDS Check presence of SVHC in articles SVHC Have chemical information available on request 78

Actions for : Material suppliers Staff awareness Collect chemical information Check usage of material by clients Check presence of SVHC in products SVHC Have chemical information available on request 79

Requirement Registration Provide formulation and figures Jakks Pacific performs pre-registration Jakks Pacific Training for suppliers and vendors (e.g. e-learning) ( e-learning ) Collect clear information on products Ensure the reliability of information Submit chemical information before shipment Upload information on an IT platform if necessary 80

Essential elements of ingredient table Material supplier name Product or component description with part number (if any), and Name of chemicals in the material with CAS number and percentage, and CAS Supplier signature, chop and date 81

Essential elements of SDS SDS( ) Issue date of SDS SDS The SDS is complied with REACH Regulation (1907/2006/EC) or revised edition SDS REACH (1907/2006/EC) Proclaim all dangerous chemicals in formulation according to the principle of EU directive 67/548/EEC and REACH regulation (1907/2006/EC) are listed on SDS 67/548/EEC REACH SDS 82

Intertek REACH Presentation, 2008 83

Advantage of e-learning e-learning The progress of each learner can be monitored Vendor can be trained anywhere with Internet access Especially suitable for remote vendors Good presentation of due diligence 84

Web-based system 85

1 st Course REACH Simplified REACH 86

Interactive Story Mode 87

Enter the maze and start your journey~! ~! 88

Highlight Divided into 4 courses: Course 1: REACH Simplified REACH Course 2: REACH in Depth REACH Course 3: Managing REACH REACH Course 4: Using SDS for Compliance SDS Lively and interactive story mode Quiz at the end of each course Chinese/English courses available NOW 89

Case Study Marker 90

Case Study Marker Which material is required by registration under REACH? Ink (preparation) ( ) Obligations under REACH for this product. REACH Registration Notification Informing recipient the presence of SVHC SVHC May need to prepare SDS for the ink SDS Authorisation if substance in Annex 14 present in ink 14 Ensure NO restricted substance in Annex 17 17 91

Case Study Marker What information is needed in order to fulfill the obligations listed above? Bill of material of the product Ingredient table / SDS of each material SDS SDS of marker ink SDS 92

Example of applicable REACH requirements REACH 1) Need Registration? 是否需要注册? Yes 是 No 否 2) If (1) is Yes, what need registration? 若 (1) 选择是, 哪些需注册? 3) Any additional information required? 是否需要其他信息? 93

IRIS Reach Ready Software Full web access for information sharing All standards management included REACH 97 Intertek REACH Presentation, 2008

Access to all technical file in progress and completed 98

Access to all technical file in progress and completed 99

Access to item composition 100

To save time, you can define template items in a library to copy and paste typical composition Transfer template into your product composition 101

Calculation for Registration 102

Calculation for Registration You can sort by. Tonnage per customer Tonnage per item Substance list for registration 103

Calculation for Notification 104

SVHC > 0.1%? 105

IRIS General summary IRIS 1. Global Compliancy Management S/W 2. Full web access s/w : data sharing 3. REACH Ready REACH 4. Technical data management : Standards, regulation, markings 5. Certificate collection 6. Registration and Notification data issues 7. Protect confidential information from suppliers 106

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Matching Needs : Vendors Staff awareness Confirm presence / absence of SVHC in products SVHC Collect chemical information for preparation Automatic IT systems Intertek E-learning, seminars and workshops Provide product REACH compliant certificate REACH Through Intertek if confidentiality needs to be preserved Intertek Intertek REACH Integrated System (IRIS) Intertek REACH 108

Q & A 109

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