The Impact of REACH Regulation on Textile and Footwear Industry

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AgendaREACH Background & Scope

Key Elements of REACH

Registration/Pre-registration & Evaluation

PowerPoint of REACH Regulation on The Impact Template Textile & Footwear IndustryDouglas WONG, PhD (Envrion. Eng.) REACH Consultant Corporate Research & Development, Hong Kong

Toxic Substances Concerned by REACH

Restriction, Authorization, Notification, Information in the Supply Chain

REACH Impact on Textile & Footwear Industry

Case Discussion

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Regulation (EC) No. 1907 / 2006

Current ProblemsRisk Assessment TestingOnly new substances are required to be tested before being placed on the market!

Registration, Evaluation, Authorization & Restriction of CHemicals

Since 1993, 141 high volume existing substances are selected for risk assessments, surprisingly only 27% have been completed!

Existing Substances 100,106 substances

New Substances 4,300 substances

REACH enter into force

Sept 1981

June 2007

Entered into Force on 1 June 20073 4

Product Regulated by REACH?Registration Restriction Notification AuthorizationRegistration Substance 1 t/yr

Registration, Evaluation, Authorization & Restriction of CHemicalsEvaluation Dossier evaluation Substance evaluation

Sub. in preparation 1 t/yr Sub. in Article (intended release) 1 t/yr

~ 30,000 substances

~ 5,000 substances

Authorization Substances of Very Concern (SVHC)Substance Sub.in preparation Sub. in article intended to be released Annex XVII SVHC in Article > 0.1%, and > 1 t/yr Annex XIV

Restriction Repeal 76/769/EEC restricts dangerous substances on its own, in preparation & in article 52 categories

1,400-2,000 substances5

300-400 substances6

REGISTRATION deadline

Main Objectives of REACH- To ensure a high level of protection of health & the environment - Put articles under regulationDIY Tools Furniture Toys Apparels Footwear Textiles Automotive Cosmetics Personal Care Products Electronic Components Electrical Appliances EXISTING SUBSTANCES (phase-in) PREREGISTRATION of all existing substances (phase-in)1 June 08 / 30 Nov. 08 (12-18 months after EIF = 6 months)

1,000 t /year, or R50-53 100 t /year, or CMR 1&2 1 t /year30 Nov. 2010 1 June 2013

REGISTRATION deadline 100 t /year

1 Jan. 09: Preregistration list published, data available)

START of NOTIFICATION of SVHC in articles1 June 2011

REGISTRATION deadline 1-100 t /year1 June 2018

SIEF (data sharing)2007 2008 2009 2010 2011 2013 2018

- Encourage data sharing & reduce animal testing

- Safeguarding innovation & competitiveness

Red uce

1 June 07: REACH enters into force

1 June 08: Helsinki Agency in operation

3,5 years after EIF

4 years after EIF

6 years after EIF

11 years after EIF

Testing DataSTART of the REGISTRATION of new substances (non-phase in)Innovation Competitiveness7 Note: Annual quantity is considered per producer or importer legal entity. 8

Glossary

Product Classification

- Chemical elements & its compoundsPigment Solvent

- Mixture of substancesShoe Cream

Eye Shadow Preparation in a container

Boy Shoes Article

Jean Skirt

Perfume

Handbag Article

Spectacles Article

Leather Belts Article

- Its shape determines its function to a greater degree than its chemical composition

Adhesive

Article with Preparation in a sub. intended to be released container

Sportshoes

Sportswear9 10

Total Exemptions under REACHREACHRadioactive substances Substances subject to customs supervisions Non-isolated intermediates The carriage of dangerous substances Waste Substances necessary for Member States defenseMedicinal products Food or feeding stuffs Cosmetic products Certain medical devices

Specific Exemptions under REACHInformation in the supply Downstream Authorization Restriction users Evaluation Registration chain Title II Title IV Title V Title VI Title VII Title VIII

Minimum risks substance Inappropriate registration substance Re-imported identical substances Registered recovered substances Transported isolated intermediates On-site isolated intermediates Polymer Reduced Reduced

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Substance & Substance in PreparationREACH Regulation Art. 6(1)Registration Evaluation

Manufacturer or importer of a substance, either on its own or in preparation, in quantities 1 t/a shall submit a registration REACH Regulation Art. 6(3)

Restriction

Authorization

Polymer manufacturer or importer shall submit a registration regarding their monomer or any other substances, if both the following conditions are met:a) The polymer consists of 2% (w/w) or more of such monomer substances or other substances in the form of monomeric units & chemically bound substances b) The totally quantities of such monomer substances or other substances 1 t/a

Information in the supply chain

Notification14

Substance in ArticleREACH Regulation Art. 7(1) Any producer or importer of articles shall submit a REGISTRATION to the Agency for any substance contained in those articles, if both the following conditions are met:

Substances Intended to be Released

(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is INTENDED TO BE RELEASED under normal or reasonably foreseeable conditions of useFragranced T-shirt Scented Eraser

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Substances/Preparation in a Special Container or a Special Carrier

Substance Not Intended to be Released

Markers

Textiles impregnated with polish

Printer cartridge

Clothes (Aromatic amines)

Leather Shoe (Chromium)

Shower curtain (Phthalates)

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Registration 1SubstancesChemical

Registration 2Sub. in ArticleFragranced T-shirt

Sub. in PreparationShoe cream

PolymerPolymer Pallets

Sub. in ArticleSportshoes

Registration required if sub. 1 t/a per manufacturer or importer

Registration required if sub. in preparation 1 t/a per manufacturer or importer

Registration required if sub. in Article is intended to be released, & > 1 t/a per manufacturer or importer for that specific use19

Registration required if monomer or other sub. 2%; & 1 t/a per manufacturer or importer

No registration required if sub. in Article is not intended to be released under normal conditions.

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Registration

Technical Dossier InformationIn Database format (IUCLID database) ID of manufacturer / importer Substance ID (e.g. name, trade name, molecular formula & weight, structure, purity, spectral data) Manufacture & use of substance Classification & Labeling Guidance on safe use (storage, disposal, first aid measures) Study Summaries (e.g. physicochemical, toxicological & ecotoxicological properties) tonnage dependent21 22

Registration requires manufacturers & importers of chemicals to obtainrelevant information on their substances & to use that data to manage them safely What is required for Registration? Technical dossier ( 1 t/a) Chemical safety report ( 10 t/a) Procedures Given the registration number Simple electronic completeness check will be performed by the Agency If registration is not rejected within a set deadline Non-phase-in substance (i.e. introduce after 1 June 2007) registrant may begin to manufacture or import the substance Phase-in substance may continue to manufacture or import the substance

Chemical Safety Report InformationHazard Assessment Human Health, Physicochemical, Environmental

European Chemical Agency (ECHA)MissionManage & coordinate the registration, evaluation, authorisation & restriction process under REACH to ensure consistency in chemicals management across the EU Provide the Member States & the Institutions of the Community with scientific & technical advice on chemicals covered by the Regulation Manage IT based guidance documents, tools & databases

Persistent, Bio-accumulative and Toxic (PTB) & very Persistent & very Bio-accumulative (vPvB) assessment If studies from above found substance to be dangerous, PBT or vPvB, also need Exposure assessment, addressing identified uses Risk characterization, identify risk control measures

Exempted if they fall within certain restriction limit requirements (e.g. Directive 1999/45/EC)

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Registration / Pre-registration TimelineNon-phase in substances Jun 2008

Calculation of Registration VolumeA UK company imports two intentional dye release textile products A & B from different Pakistan manufacturers, with 100g of dye X in each In product A, 80% dye are released under normal conditions In product B, 10% dye are released under normal conditions1 t Jun 2018

Volume

Pre-registration Jun-Nov 2008

Question: Does the UK Company need to register substance X if it imports 2,000,000 product A & 1,000,000 product B?

Nov 20101000 t , 1 t CMR cat.1 &2, 100 t R50-53

100 t Jun 2013Notification of SVHC

Product A Weight: 1.2kgYear

Product B Weight: 1kg

EIF Jun 2007

Agency in operation Jun 2008 Pre-reg. list published

Jan 2009

SIEF data available

June 201125

Assume articles26

Calculation of Registration Volume (Contd)Answer Whenever a substance is intended to be released from an article The TOTAL QUANTITY of

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