chemical compliance for smart wearable devices in eu & us
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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
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
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
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
16
FOR THE EU MARKET
Skin Contact Part RoHS
WEEE
Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
As an Electrical & Electronic Equipment
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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
18
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
Skin Contact Part RoHS
WEEE
Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
As an Electrical & Electronic Equipment
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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
22
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
23
FOR THE EU MARKET
Skin Contact Part RoHS
WEEE
Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
As an Electrical & Electronic Equipment
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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%
25
EU BATTERY DIRECTIVE
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
26
EU BATTERY DIRECTIVE
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
27
FOR THE EU MARKET
Electrical & Electronic Equipment
Containing Skin Contact Part
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
• RoHS
• WEEE
• Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
28
FOR THE EU MARKET
Electrical & Electronic Equipment
Containing Skin Contact Part
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
• RoHS
• WEEE
• Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• 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
REACH ANNEX XVII RESTRICTIONS
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
REACH ANNEX XVII RESTRICTIONS
Entry Substance Reference Limit
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
Electrical & Electronic Equipment
Containing Skin Contact Part
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
• RoHS
• WEEE
• Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
34
ALLERGENIC EFFECT TESTS
Nickel release
Organotin content
Allergenous dyes / Disperse Dyes
Cancerogenic dyes
In-vitro cytotoxicity
Irritation
35
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
Electrical & Electronic Equipment
Skin Contact Part • RoHS
• WEEE
• Battery
Finished article
• REACH SVHC
• Packaging
• POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
37
ANNEX XVII RESTRICTIONS
Entry Substance Reference Limit
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
Electrical & Electronic Equipment
Skin Contact Part • RoHS
• WEEE
• Battery
Finished article
REACH SVHC
Packaging
POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
39
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
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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
Electrical & Electronic Equipment
Skin Contact Part • RoHS
• WEEE
• Battery
Finished article
REACH SVHC
Packaging
POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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
Electrical & Electronic Equipment
Skin Contact Part • RoHS
• WEEE
• Battery
Finished article
REACH SVHC
Packaging
POPs
Specific Material & Application
REACH Annex XVII Restrictions
• Cadmium
• Lead
• Organotin
• DMF
• REACH Annex XVII Restrictions
Nickel release
Chromium VI
Brominated flame retardants
Azo dyes
Polycyclic aromatic hydrocarbons
• Allergenic Effect
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
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
48
FOR THE US MARKET
Electrical & Electronic Equipment
• Battery
Finished article
• TPCH (Packaging)
• Prop 65
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
WWW.SGS.COM
joern.brembach@sgs.com
0031-622497196
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