Chemical Compliance For Smart Wearable Devices in EU & US ...

Chemical Compliance For

Smart Wearable Devices

in EU & US Markets

2

Nº1

WORLD LEADER TIC Industry 5.9 Bill. CHF rev. 16.1 % margin

84,000

EMPLOYEES

1,650

OFFICES AND LABORATORIES

13

GLOBAL INDUSTRIES/ Business lines

GLOBAL SERVICE LOCAL EXPERTISE

AT A GLANCE

3

CONSUMER GOODS & RETAIL (1 of 13 global

Business lines)

TOYS JUVENILE PRODUCTS

TEXTILES & FOOTWEARS

ELECTRICAL& ELECTRONICS

FOOD

COSMETICS, PERSONAL CARE & HOUSEHOLD

WE COVER A BROAD RANGE OF CONSUMER GOODS

HARDGOODS

SUPPORTING SERVICES INSPECTION SOCIAL AUDIT ENERGY & CARBON SYSTEMS & SERVICES CERTIFICATION

4

E/E NETHERLANDS COMING SOON…

5

SMART

WEARABLE

DEVICE

*Photo captured on internet

6

High Plasticity and Creativity

Cross Category Products

Multi-Purpose

Interactive

Personalized

Irreversible Development

CHARACTERISTICS

7

Chemical

CE-RoHS, REACH, WEEE, Battery Directive

RF

CE-R&TTE, FCC, IC, A-tick, KC, Anatel, SRRC

Safety

CE-LVD, Battery Safety

Compliance on Different Product Scopes: HL, SL, Toy etc.

A) Compliance by Different Nations

REQUIREMENTS: COMPLIANCE

8

Patent Testing and Approval on BT, WiFi, NFC

Transportation Safety UN 38.3

Protocols

Systems and Social Responsibility Audit

Inspection

B) Patent, International & Buyer’s Protocol

REQUIREMENTS: PATENT, INT’L & BUYER

9

Sensitive – Skin Contact Materials

Index of Protection

Durability

Experience on human interaction, physical

world interaction

Performance on dynamic access &

interoperability of multi-functions

C) Performance

REQUIREMENTS: PERFORMANCE

Feature Presentation Focus on Compliance, only

1) Chemical Requirements

2) RF & EMC

Requirements

3) Safety Requirements

Chemical Compliance

13

REQUIREMENTS FOR EU MARKET

14

FOR THE EU MARKET

Electrical & Electronic Equipment

Skin Contact Part • RoHS

• WEEE

• Battery

Finished article

• REACH SVHC

• Packaging

• POPs

Specific Material & Application

REACH Annex XVII Restrictions

• Cadmium

• Lead

• Organ tin

• DMF

• REACH Annex XVII Restrictions

Nickel release

Chromium VI

Brominated flame retardants

Azo dyes

Polycyclic aromatic hydrocarbons

• Allergenic Effect

15

FOR THE EU MARKET

As an Electrical & Electronic Equipment

Skin Contact Part RoHS

WEEE

Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



16

FOR THE EU MARKET


WEEE

Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF



Nickel release

Chromium VI


Azo dyes



17

ROHS

Directive 2011/65/EU

Recast Directive 2002/95/EC

Most up-to-date version

RoHS 2.0

Part of CE marking requirement

Electrical and electronic equipment (EEE)

Equipment which needs electric currents or electromagnetic fields to

fulfill at least one intended function

Including cables and spare parts

Restriction of the use of certain Hazardous Substances

in electrical and electronic equipment

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Restriction of the use of certain Hazardous Substances

in electrical and electronic equipment

MAXIMUM CONCENTRATION VALUES (MCV)

One material of uniform composition

Combination of materials that cannot be disjointed or

separated into different materials by mechanical actions

Hazardous Substance By weight in

homogeneous materials

Lead (Pb) 0.1%

Mercury (Hg) 0.1%

Cadmium (Cd) 0.01%

Hexavalent chromium (Cr(VI)) 0.1%

Polybrominated diphenyls (PBBs) 0.1%

Polybrominated diphenyl ethers (PBDEs) 0.1%

Homogeneous

Material

19

FOR THE EU MARKET


WEEE

Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF



Nickel release

Chromium VI


Azo dyes



20

WHAT IS WEEE?

Waste Electrical and Electronic Equipment

Directive 2012/19/EU

Recast Directive 2002/96/EC

Most up-to-date version

WEEE 2.0

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MAIN PROVISIONS

Collection

Treatment

Recycling & recovery

Labeling

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MOST CONCERNED REQUIREMENTS

Recovery targets

Information for users

Not to dispose of WEEE as unsorted municipal waste

Return and collection systems available to them

Educative information

Meaning of the cross-out wheeled bin marking

Appropriately mark EEE placed on the market

(after 13 Aug 2005) with the Crossed-out wheeled

bin symbol in Annex IX

CENELEC: EN 50419:2006

• Label format

• Standard dimension

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FOR THE EU MARKET


WEEE

Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF



Nickel release

Chromium VI


Azo dyes



24

Directive 2006/66/EC

Directive 2013/56/EU amending Directive 2006/66/EC

Mercury content

EU BATTERY DIRECTIVE

Battery Type

(whether or not incorporated

into appliances)

Requirement After 1 October 2015

Button cells Hg≤2% Hg ≤0.0005%

Other batteries or accumulators Hg ≤0.0005%

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Battery Type

(whether or not incorporated into

appliances)

Requirement After 31

December 2016

Portable

batteries or

accumulators

(including

button cells)

intended for

use in

Emergency and alarm

systems, including

emergency lighting

Not limited

Medical equipment Not limited

Cordless power tools Not limited Cd≤0.002%

Other appliances Cd≤0.002%

Cadmium content

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Labelling

All batteries, accumulators and battery packs marked with the

crossed-out wheeled bin symbols

With the chemical symbol if

Hg>0.0005%

Cd>0.002%

Pb>0.004%

Standard dimension

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FOR THE EU MARKET


Containing Skin Contact Part


Nickel release

Chromium VI


Azo dyes



• RoHS

• WEEE

• Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF

28

FOR THE EU MARKET




Nickel release

Chromium VI


Azo dyes



• RoHS

• WEEE

• Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF

29

REACH ANNEX XVII RESTRICTIONS

Restrictions on the manufacture, placing on the market and use of

certain dangerous substances, mixtures and articles

Product

Application and material

mentioned in any Entry in Annex XVII?

Adopt the limits

specified in the Entry

No obligation

Yes No

30


Annex XVII Restrictions concerning material intended to

come into contact with the skin

Entry Substance Reference Limit

27 Nickel release

Body-piercing

<0.2 μg/cm2/week

Non-body-piercing

≤0.5 μg/cm2/week

47 Chromium VI compounds

Leather parts in articles

<3 mg/kg of that part

Effective date: 1 May 2015

4, 7, 8

Brominated Flame Retardants

• Tris(2,3-dibromopropyl) phosphate (TRIS)

• Tris(aziridinyl) phophinoxide (TEPA)

• Polybromobiphenyls;

polybrominatedbiphenyls (PBB)

Shall not be used in textile articles

31



43 Azo Dyes ≤0.003% (w/w) in article / dyed part

50 Polycyclic Aromatic

Hydrocarbon (PAH)

Article: ≤0.0001% (w/w) of the component

Toys, children articles: ≤0.00005% (w/w) of

the component

Effective date: 27 Dec 2015

Annex XVII Restrictions concerning material intended to

come into contact with the skin

32

FOR THE EU MARKET




Nickel release

Chromium VI


Azo dyes



• RoHS

• WEEE

• Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF

33

ALLERGENIC CASES

34

ALLERGENIC EFFECT TESTS

Nickel release

Organotin content

Allergenous dyes / Disperse Dyes

Cancerogenic dyes

In-vitro cytotoxicity

Irritation

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NICKEL RELEASE

Rate of nickel release

How much nickel is released from the skin-contact part per cm2 per week

Under normal and foreseeable use

Strategy Standard Test Method

Simulate wear

and corrosion

after normal use

EN 12472:2005

Simulate wear and corrosion during two year of normal use

+ Abrasive paste

Abrasion

for 5 hrs

36

FOR THE EU MARKET



• WEEE

• Battery

Finished article

• REACH SVHC

• Packaging

• POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



37

ANNEX XVII RESTRICTIONS


23 Cadmium

Article: <0.01% (w/w) in the plastic material

Paint: <0.1% (w/w) of the paint

Metal parts of jewellery: <0.01% (w/w) of the

metal

63 Lead <0.05% in an individual part of jewellery articles

20 Organotin

(TBT, TPT, DBT, DOT) ≤0.1% by weight of tin per article / part

61 Dimethylfumarate

(DMF) ≤0.1 mg/kg in article

Annex XVII Restrictions concerning specific

materials and application

38

FOR THE EU MARKET



• WEEE

• Battery

Finished article

REACH SVHC

Packaging

POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



39

FOR THE EU MARKET



• WEEE

• Battery

Finished article

REACH SVHC

Packaging

POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



40

SVHC OBLIGATIONS FOR ARTICLE

Article

Any SVHC in the Candidate List > 0.1%

by weight?

Annual import of

that SVHC > 1 ton?

Notification by

REACH IT

Yes No

No more obligation

Yes No

Communication

No more obligation

41

FOR THE EU MARKET



• WEEE

• Battery

Finished article

REACH SVHC

Packaging

POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



42

EU PACKAGING DIRECTIVE (94/62/EC)

‘Packaging' shall mean all

products made of any materials

of any nature to be used for the

containment, protection,

handling, delivery and

presentation of goods, from raw

materials to processed goods,

from the producer to the user or

the consumer.

Examples

Paper or plastic carrier bags/boxes

Film overwrap around a CD case

Labels hung directly on or attached

to a product

43

EU PACKAGING REQUIREMENTS

Product Regulated

Substances

Requirement

Packaging & packaging

components

• Lead

• Mercury

• Cadmium

• Chromium VI

Sum <0.01%

44

FOR THE EU MARKET



• WEEE

• Battery

Finished article

REACH SVHC

Packaging

POPs



• Cadmium

• Lead

• Organotin

• DMF


Nickel release

Chromium VI


Azo dyes



45

EU POPS REGULATION

Persistent Organic Pollutants (POPs)

Organic chemicals (carbon-based)

Persistent

Slow degradation

Remain intact for exceptionally long periods of time

(many years)

Bioaccumulate through the food web

Concentrate in living organisms

Toxic to humans & wildlife

Cancer, allergies and hypersensitivity, damage to the

central and peripheral nervous systems, reproductive

disorders,

and disruption of the immune system

http://www.google.com/url?url=http://www.labelmaster.com/shop/safety/ghs-hazcom-products/ghs-tank-placards/ghs-skull-and-crossbones-pictogram-tank-placards&rct=j&frm=1&q=&esrc=s&sa=U&ei=YLEOVK_rN9DY8gX0zoKABg&ved=0CCwQ9QEwCw&usg=AFQjCNE0Sql7wsrBJYBsYL4dZmCPwuOlJg

http://www.google.com/url?url=http://www.labelmaster.com/shop/safety/ghs-hazcom-products/ghs-tank-placards/ghs-environment-pictogram-tank-placards&rct=j&frm=1&q=&esrc=s&sa=U&ei=YLEOVK_rN9DY8gX0zoKABg&ved=0CDIQ9QEwDg&usg=AFQjCNEEO72jmEPfW5GLhRAuboRPiRcgjg

46

EU POPS REGULATION

Substances subject to…

The Protocol

The Convention

Regulation (EC) No 850/2004 on Persistent Organic

Pollutants (POPs)

Annex I: Prohibition (23 entries)

Annex II: Restriction (no listed substance at the moment)

Objectives

1. Protect human health and the environment

2. Prohibiting

3. Phasing out

4. Restricting the production, placing on the market & use

47

REQUIREMENTS FOR US MARKET

48

FOR THE US MARKET


• Battery

Finished article

• TPCH (Packaging)

• Prop 65

59

ONE MORE SLIDE…

60

Testing Proposal to Client

(remark: Smart Electronics devices and it’s compliance/ Patent,

Int’l & Buyer/ performance are complex in certain case,

customer meeting with sample and details specification is highly

recommended.)

Approval of Test Plan

Submit sample and relevant technical document

PCB Layout, Bill of Materials, Circuit Diagram, Explosive

Diagram, Component Certificate, Marking, Instruction

Manual, etc.

Preliminary product review

(International) Product Testing + report

(global) Certification and registration

SUMMARY

GENERAL PROJECT HANDLING PROCEDURE

http://www.google.at/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0CAcQjRw&url=http://neuerdings.com/2015/01/10/kraftwerk-akku-fuer-mobile-geraete-mit-gaspatronen-aufladen/&ei=HGtsVfehLoPq7AbjuYHgDA&bvm=bv.94455598,d.ZGU&psig=AFQjCNHXdFnvbH-8Y-yNZ72dmlYn1WOBOg&ust=1433255023256618

WWW.SGS.COM

[email protected]

0031-622497196

http://www.sgs.com/

mailto:[email protected]

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Chemical Compliance For Smart Wearable Devices in EU & US ...

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