TÜV SÜD Product Service Slide 1 EU Footwear Regulatory Requirements 3/30/17

March 28, 2017 Designing Compliance Programs That Address Global Challenges (EU and China) Ben DeVito

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TÜV SÜD Product Service Slide 2 EU Footwear Regulatory Requirements

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International Regulated and Safety Standards

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We frequently get requests to develop testing protocols to cover various countries. Most are highly customized to a clients requirements We have worked with FDRA on various initiatives – RLS and Physical Testing Today we will take a quick look at China and EU

International Regulated and Safety Standards

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In China we primarily have the “GB” National Standard; and then “lesser” standards

In the EU we primarily have the Reach regulations Registration, Evaluation, Authorisation and Restriction of Chemicals

Slide 5

Scope Mandatory standard Voluntary standard

National standard GB GB/T

Industrial standard FZ, QB, HG…. FZ/T, QB/T, HG/T….

Province standard DB DB/T

Enterprise standard Q/XXXX Q/XXXX

China Standardization System Structure

Chinese standard identification

3/30/17 Enter the Chinese Market with EASE

Labeling - GB 5296.4-2012

合格证 产品名称：

产品标准：

安全类别： GB 18401-2010 C 类

号型/规格：170/85A

纤维成份： 见内标

公司名称：

公司地址：

售价：

女士羽绒服

GB/T 14272 - 2011

xxxxxxx

上海市南京西路xxxxxxxxx

产品等级： 合格品

1000.00 元

(for imported goods, it should be the name and address of importer, distributor or dealer, plus the country of origin)

洗涤方式：

•  3/30/17 GB Services Slide 6 TÜV SÜD Slide 6 3/30/17 Enter the Chinese Market with EASE

!  Certification Tag !  Product Name !  Product Standard !  Quality Grade !  Safety Code !  Size !  Fiber Content !  Care Instruction !  Manufacture Name !  Manufacture Address

Import Stage Domestic Market

CIQ Landlord AIC QTS CA “Professional” Customer

Label requirement

GB 5296.4 -

2012

Action take

Port inspection (according to CIQ mandatory testing HS code list)

Random check by some of the shopping malls and department stores

Market spot check and lab test (national level & province level)

Market spot check and lab test (national level & province level)

Random check

Random check and find non-compliance item

Potential risk occurred once failed

Re-label in CIQ certified warehouse

Re-label or ban to sell in this shopping mall / department store

Big penalty and media exposure

Pull off shelves and media exposure

Media exposure

Triple money refund and media exposure

Market Supervision Matrix – Label

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GB Services Slide 7 TÜV SÜD Slide 18 3/30/17 Enter the Chinese Market with EASE

Market Supervision Matrix – Fiber Composition

Import Stage Domestic Market

CIQ Landlord AIC QTS CA “Professional” Customer

Fiber composition requirement

GB/T

29862-2013

Action take

Port inspection (according to CIQ mandatory testing HS code list)

Specified GB Test report requested by some of the shopping malls and department stores

Market spot check and lab test (national level & province level)

Market spot check and lab test (national level & province level)

Random check by CA and test by CA selected lab (government lab)

Check composition info. on CIT and send to a lab to do fiber composition analysis test

Potential risk occurred once failed

Destroy or return back to original port

Ban to sell in this shopping mall / department store

Big penalty and media exposure

Pull off shelves and media exposure

Media exposure

Triple money refund and media exposure

3/30/17 Enter the Chinese Market with EASE

Market Supervision Matrix – General Safety Code

Import Stage Domestic Market

CIQ Landlord AIC QTS CA “Professional” Customer

General safety code

requirement

GB 18401 GB 20400 GB 28480

Action take

Port inspection (according to CIQ mandatory testing HS code list)

Specified GB Test report requested by some of the shopping mall and department store

Market spot check and lab test (national level & province level)

Market spot check and lab test (national level & province level)

Random check by CA and test by CA selected lab (government lab)

N/A

Potential risk occurred once failed

Destroy or return back to original port

Ban to sell in this shopping mall / department store

Big penalty and media exposure

Pull off shelves and media exposure

Media exposure

N/A

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Market Supervision Matrix – Product Standard

Import Stage Domestic Market

CIQ Landlord AIC QTS CA “Professional” Customer

Product standard

requirement

Action take

N/A

N/A

Market spot check and lab test (national level & province level)

Market spot check and lab test (national level & province level)

Random check by CA and test by CA selected lab (government lab)

Focus on certain critical test requirement (e.g.: colorfastness to wet rubbing) and send to a lab to do test

Potential risk occurred once failed

N/A

N/A

Big penalty and media exposure

Pull off shelves and media exposure

Media expose

Triple money refund and media expose

3/30/17 Enter the Chinese Market with EASE

AIC Penalty Calculation

Calculation Part 1: confiscate illegal income

Calculation Part 2: fine

selling price Import price sales quantity1 tax

selling price import quantity2 ratio (0.5 ~ 3)

1.  sales quantity is not defined clearly in SAIC doc. if it is for: !  all sales quantity for the same style for all shops !  all sales quantity for the same style for the same shop !  all sales quantity for all styles which made by same fabric /

different color

2.  import quantity is not defined clearly in the law if it is for: !  all import quantity for this import batch !  all import quantity for all import batches

3/30/17 Enter the Chinese Market with EASE

Overview of EU footwear regulatory requirements

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•  General Product Safety Directive 2001/95/EC –  Products available in the EU market must be Safe !  Small Parts !  Sharp Point/Sharp Edge –  Ensure the tractability of the products – Must have the manufacturer/

importer name and address

•  Footwear labelling Directive 94/11/EC !  Materials information

•  Chemical Regulations –  REACH Regulation (EC) 1907/2006 –  POPs Regulation (EC) No 850/2004 (Persistent Organic Pollutants)

EU restricted substances for footwear

•  Currently under EU REACH Regulation, POPs

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–  Azo –  Nickel –  Cadmium –  Chromium VI –  Dimethyl fumarate (DMFu) –  Organotin compounds –  Lead –  Phthalates –  Polycyclic aromatic hydrocarbons

(PAH) –  Perfluorooctane sulfonic acid and its

derivatives (PFOS) –  Short-chain chlorinate paraffins

(SCCPs)

•  Upcoming requirements

- REACH Annex XVII Entry 46a – Nonylphenol ethoxylates (NPEs) for textiles that can be washed (will apply from 3 February 2021) •  Proposed restriction -  Perfluorooctanoic acid (PFOA), its

salts and PFOA-related substances (Possible affect footwear with water/oil repellent property) -  CMR substances in articles with skin

contact

Latest updates of REACH – SVHC Candidate List

•  16th update of the Candidate List !  On 12 January 2017, the European Chemicals Agency (ECHA) has added 4 new

substances in the REACH Candidate List !  The total number of SVHCs listed on the Candidate List increases from 169 to 173

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Why do you need compliance?

Unsafe products

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EU RAPEX - The rapid alert system for non-food dangerous products Dangerous products are reported weekly. RAPEX shows the risk and the measures taken by the EU authorities. The information is publicly available. Reference Link: http://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/main/?event=main.listNotifications

RAPEX notifications on footwear in 2016

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27 25

3

0

5

10

15

20

25

30

Choking - small parts Chromium VI Dimethyl fumarate (DMFu)

2016 – Number of notified cases related to footwear

-  Total 55 RAPEX notifications on footwear in 2016 -  Three types of risks:

-  Safety – choking hazard -  Chemical – chromium and dimethylfumarate (DMFu)

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4 2 2 2 1

7

16

1 1

19

0 2 4 6 8

10 12 14 16 18 20

Bulgaria Czech Republic

Estonia Finland France Germany Hungary Italy Slovenia Spain

2016 - Notifying Country of notifications on footwear

RAPEX notifications on footwear in 2016

-  Total 10 notifying countries on footwear in 2016 -  Top 3 notifying countries: Spain, Hungary, Germany

RAPEX Notification Case - Choking

Babies boots Notified by: Hungary Manufactured in: Unknown Risk type: •  Choking - The small decorative rhinestones and flowers can easily detach. A small child may put them in the mouth and choke. Regulatory basis: •  General product safety directive 2001/95/EC Measures adopted by public authorities: •  Recall of the product from end users •  Withdrawal of the product from the market

2016 – report 36 Case no. A12/1104/16

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RAPEX Notification Case - Chromium VI

Ladies' shoes Notified by: Germany Manufactured in: China Hazardous chemical(s): •  The leather lining and insole of the shoes: - Chromium VI (83 mg/kg and 62 mg/kg respectively) Regulatory basis: •  REACH Annex XVII Entry 47 Measures adopted by economic operators: •  Withdrawal of the product from the market

2016 – report 12 Case no. A12/0351/16

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Requirement of REACH Annex XVII Entry 47 Scope of restriction •  Leather articles and articles containing leather parts coming into contact with the skin Limit •  < 3 mg/kg be weight of the total dry weight of the leather

RAPEX Notification Case - DMFu

Women’s shoes Notified by: Italy Manufactured in: China Hazardous chemical(s): •  The insole and upper of the shoes: - Dimethylfumarate (DMFU) (0.118 mg/kg and 0.129 mg/kg respectively) Regulatory basis: •  REACH Annex XVII Entry 61 Measures adopted by public authorities: •  Ban on the marketing of the product and any accompanying measures

2016 – report 4 Case no. A12/0072/16

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Requirement of REACH Annex XVII Entry 61 Scope of restriction •  Articles containing DMFu Limit •  Articles or any parts ≤ 0.1 mg/kg

Summary

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•  Product Safety regulations vary by region/country

•  As you build a safety program you must consider;

–  Product category, age grade and materials

–  Risk tolerance

– Method of distribution

– Market surveillance

•  There are ways to approach testing and to test “smartly” !  Materials information

•  Keep Informed and have a plan

Questions?

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GB Services Slide 22 TÜV SÜD Slide 28 3/30/17 Enter the Chinese Market with EASE

Thank You Website: www.tuv-sud.com Ben DeVito Email: bdevito@tuvam.com