updates of certain chemical requirements to eu...
TRANSCRIPT
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16.09.2011 Greater China Softlines
Updates
Of
Certain Chemical
Requirements
to EU market
16.09.2011 Greater China Softlines
Recast Directive
of
EU RoHS
(2011/65/EEC)
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EU RoHS directive
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� RoHS-- Restriction of the use of certain Hazardous Substances in EEE
� EEE -- Electrical & Electronic Equipment
means equipments which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation / transfer / measurement of such currents and fields and designed for use with a voltage rating
< 1000AV (volts for alternating current), or< 1500DV (volts for direct current)
EU RoHS directive
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EU RoHS directive
CE marking-Marking
21-Jul-20111-Jul-2006Date of
implementation
Producer / Distributor / ImporterProducer Obligation party
Exemption list with transitional period Exemption listExemptions
XRF + chemical confirming Testing
Hg / Cr VI / Pb / PBB / PBDE -- 0.1% (=1000ppm, individual)
Cd -- 0.01% (=100ppm)
Restriction of
harmful substances
EEE of 11 categoriesEEE of 8 categoriesProduct scope
2011/65/EC2002/95/ECEC no.
Recast RoHS directiveFormer RoHS directive
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� Product scope
EU RoHS directive - scope
1. Large household appliances;
2. Small household appliances;
3. IT & telecommunications
equipment;
4. Consumer equipment;
5. Lighting equipment;
6. Electrical & electronic tools;
(except for large-scale stationary
industrial tools)
7. Toys, leisure & sports equipment
8. Medical devices;(except for implanted & infected
devices)
9. Monitoring & control instruments(including industrial monitoring &
control instruments)
10.Automatic dispensers
11.Other electrical and electronic
equipment not covered by any
of the categories above
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� Product scope exclusions
EU RoHS directive - scope
� Equipment which is necessary for the protection of the essential interests of the security of
Member States, including arms, munitions and war material intended for specially military purpose
� Equipment designed to be sent into space
� Equipment which is specially designed and to be installed as part of another type of
equipment that is excluded or does not fall within the scope of this Directive, which can fulfil
its function only if it is part of that equipment, and which can be replaced only by the same
specially designed equipment
� Large-scale stationary industrial tools & larg-scale fixed installations
� Means of transport for persons or goods, excluding electric two-wheel vehicles which are
not type-approved
� Non-road mobile machinery made available exclusively for professional use
� Active implantable medical devices
� Photovoltaic panels intended to be used in a system that is designed, assembled and installed by professionals for permanent use at a defined location to produce energy from solar light for public, commercial, industrial and residential application
� Equipment specially designed solely for the purposes of research and development only
made available on a business-to business basis
� Batteries and accumulators (2006/66/EC Directive)
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� Product scope about specific provisions
EU RoHS directive - scope
� Cables and Spare Parts -- fall in RoHS product scope
Cables – all cables with a rated voltage <250V that serves as a connection or an
extension to connect EEE to the electrical outlet or to connect two or more EEE to each other.
Spare parts – a separate part of an EEE that can replace a part of an EEE. The
EEE cannot function as intended without that part of the EEE. The functionality of EEE is restored or is upgraded when the part is replaced by a space part.
� Consumables and Accessories -- NOT fall in RoHS product scope
e.g. CDs & DVDs / ink cartridges / floppy disks / badges, etc.
Because:
> they are not electric or electronic equipment
> they are not to be considered as EEE even if they have some EE components
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Recast RoHS Directive (RoHS II)- 2011/65/EC
EU RoHS directive
-- to be entered into force on 21-Jul 2011 and will repeal current directive of
2002/95/EC with effect from 3-Jan-2013
22-7-2019Other Electrical & Electronic Equipment (EEE) that are not covered
by 2002/95/EC and it is not comply with 2011/65/EC
22-7-2017Industrial monitoring & control instruments
22-7-2016In Vitro Diagnostic medical devices(IVDD) 22-7-2014Medical devices / Monitoring & control instruments
Transitional
periodProduct scope
General review of recast RoHS directive will be destined on 22-Jul-2021
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� Restriction of harmful substances
� Heavy metals :� Lead (Pb)� Mercury (Hg)� Cadmium (Cd)� Chromium (Cr VI)
� Certain brominated flame retardants:� Polybrominated biphenyls (PBB’s)� Polybrominated diphenyl ethers (PBDE’s).
Maximum limits:
� 0.01% (100 ppm) of Cadmium
� 0.1% (1000ppm) of Lead, mercury, chromium (VI), PBB’s & PBDE’s.
EU RoHS directive – restricted substances
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� Restriction of harmful substances
� Additional requirement:
1. any review and amendment MUST be coherent with Regulation 1907/2006 REACH
2. The risks arising from the use of some hazardous substances shall be considered as a priority
EU RoHS directive - restricted substances
cas no. 84-74-2Dibutyl phthalateDBP
cas no. 85-68-7Benzyl butyl phthalate BBP
cas no. 117-81-7Bis (2-ethyl(hexyl)phthalate)DEHP
cas no. 25637-99-4HexabromocyclododecaneHBCDD
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MCV – Maximum Concentration Values
is expressed as a percentage of the weight
of the “homogeneous material” for
restricted substances.e.g. 6 parts of homogeneous materials could be disassembled from a capacitorHomogeneous material: one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing/cutting/crushing/grinding and abrasive processes.
EU RoHS directive - testing
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Screening++++chemical confirming test -- recommended by IEC 62321
EU RoHS directive - testing
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EU RoHS directive - exemptions
The recast RoHS Directive contains the full list of all applicable exemptions with
relation of actions and timing.
… …… …
Expires on 1-Jan-2012 and after that date
may be used in spare parts for EEE placed on
the market before 1-Jan-2012
Cadmium(Cd) and its compounds in one shot
pellet type thermal cut-offs
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Expires on 1-Jan-2013 and after that date
may be used in spare parts for EEE placed on
the market before 1-Jan-2013
Lead (Pb) in dielectric ceramic in capacitors for
a rated voltage of less than 125V AC or 250V DC
7(c)-
III
Expires on 31-Dec-2011;
3.5mg may be used per burner after 31-Dec-
2011
For general lighting purposes, Mercury((((Hg))))in single capped (compact) fluorescent lamps not
exceeding (per burner) >30W and <50W -- 5mg
1(b)
Scope & dates of applicabilityExemption
Adobe Acrobat
Document
� RoHS Exemptions
This exemption annex will be repealed with effect from 3-Jan-2013
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EU RoHS directive - obligation
-- CE marking:shall be affixed in all EEE or its data place before it is placed on
the market . Or at least, shall be affixed to the packaging & to the accompanying documents.
-- Conformity assessment & Technical documentation
Manufacturer has to fulfill the legislative requirements applying to the product and issues the EC Declaration of conformity (DoC) & a technical documentation to state that product has been demonstrated that the requirements have been met.
-- Other obligations of economic operators
� EEE identification (type, batch or serial no. or other element allowing its identification)
� other obliged labeling: product trade name / trade mark, manufactures & imports
address on the EEE, etc.
� Alignment with New Legislative Framework (NLF)
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EU RoHS directive - obligation
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EU RoHS directive – obligation parties
� obligation parties
1. manufacturers are required to draw up the EU Declaration of Conformity,labeling EEE and prepare the technical documentation to
show compliance of six banned chemical substances
(Cd/Pb/Hg/CrVI/PBB/PBDE) for EEE products.
2. manufacturers, importers, authorized representatives and distributors shall
keep all relevant documents for 10 years for the market surveillance.
3. Before placing an EEE on the market, manufacturers, importers or
distributores must ensure that the appropriate conformity assessment procedure has been carried out
According to recast directive of RoHS II,only the product
declaration is NOT enough for RoHS compliance!!
16.09.2011 Greater China Softlines
EU RoHS directive
CE marking-Marking
21-Jul-20111-Jul-2006Date of
implementation
Producer / Distributor / ImporterProducer Obligation party
Exemption list with transitional period Exemption listExemptions
XRF + chemical confirming Testing
Hg / Cr VI / Pb / PBB / PBDE -- 0.1% (=1000ppm, individual)
Cd -- 0.01% (=100ppm)
Restriction of
harmful substances
EEE of 11 categoriesEEE of 8 categoriesProduct scope
2011/65/EC2002/95/ECEC no.
Recast RoHS directiveFormer RoHS directive
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1907/2006/EC REACH(Registrations, Evaluation &
Authorization of Chemicals)
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� quality control from EU market: weekly overview report of RAPEX notifications
http://ec.europa.eu/consumers/dyna/rapex/create_rapex.cfm?rx_id=289
Incompliance
of REACH,,,,withdrawal
from German
market &
recalled from
consumers
REACH
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Information available to the article suppliers necessary to ensure safe
use of an article has to be provided also to consumers upon request
(Article 33(2)). Consumers have to be provided with information within
45 days of the request, free of charge.
Request safe use of
article information
Reply within
45 days
REACH
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REACH
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REACH
� Definition in REACH regulation---- Chemical SubstanceMaterial / chemical subtsance with only single CAS / EINECS no.
CAS: Chemical Abstracts Service Registry Number
EINECS:European Inventory of Existing Commercial Chemical Substances ---- ArticleAn object which during production is given a special shape, surface or designwhich determines its function to a greater degree than its chemical composition.
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REACH
� basic requirement about REACH:
1. Registration
2. Evaluation
3. Authorization
Chemicals > 1ton per year
Manufacturer or importer � (information)
� database of REACH union.
Authority perform a serious evaluation for
the information of chemicals.
Authority restrict the scope for using
For Especial Chemicals (SVHC)
Chemicals > 1ton/year in EU market and related product are in REACH scope
(-- for chemical substances)
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REACH
� Notification (-- for Article Producer)
If there are any SVHC contained in Articles and,》concentration > 0.1% (by product weight)》SVHC by weight tonnage in the articles > 1ton per year》no relevant registration before
SVHC - Substances of Very High Concern
Schedule:
-- SVHC listed before 2010.12.01 – to be notified before 2011.06.01
-- SVHC listed after 2010.12.01 – to be notified within 6months after implement
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REACH
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REACH - SVHC list
� SVHC authorization list
• ECHA meeting on Apr.2011 agreed on the identification of new 7 SVHC that may
become subject to authorization.
• So that, the candidate list now has total 53 Substances of very high concern
9
2
1
3
6
7
SVHC
substances
乙醇类有机物Aluminosilicate
Boric & Borate disodium
substances
Cobalt substances
Chromate &
Dichromate substances
Arsenide
Category
2Organic substances (other)
2Other dyestuff
3AZO dyes
5Flame Retardant
9Plasticizer (Phthalates)
4Anthracene & Anthracene oil
substances
SVHC
substancesCategory
http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
16.09.2011 Greater China Softlines
REACH -Annex XVII
REACH Annex XVII --““““Restrictions on the marketing and use of certain dangerous
substances and preparations””””with effect from 1-Jun-2009 to replace EU 76/769/EC
> Heavy metal contnent of Cadmium(Cd), Lead(Pb), Mercury(Hg),
Arsenic(As), Chromium(Cr), Copper(Cu), Nickel(Ni), Beryllium(Be)
> PAHs, Phthalates, Phenols, Halogenides, AZO compounds & Amines,
Asbestos
> banned Brominated Flame Retardants, Organotin,
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� chemical tests for certain harmful substances
REACH -Annex XVII
√√Phthalates(√)
√√Metal
(√)√SCCP(C10-13)√Chromium VI
(√)
√√√√√√√√Leather
(√)
√√√√Plastic
(√)(√)Other harmful substances
√PAHs
√√Extractable Heavy Metal√√Flame Retardant substances
√DMFu - Dimethyl Fumarate
√√Organotin√√NP & NPEO√√Formaldehyde content
√Allergenic & Carcinogenic dyes
(√)√Banned AZO dyes
Coating / paintingTextile
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REACH
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Product evaluation before testing
1. Material disassembling
REACH – SVHC testing
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Product evaluation before testing
1. Material disassembling
REACH – SVHC testing
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Product evaluation before testing
2. Test preparation》Grouping concept – basing on components’ raw material:soft plastic; hard plastic; metal;
electronic components; coating / painting;
ceramic & glass; textile & leather;
other accessories; etc.
REACH – SVHC testing
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REACH – SVHC testing & reporting
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Calculation after testing》 Step-1 -- actual testing figure / test result aftering SVHC evaluation》 Step-2 -- SVHC concentration in product
to calculate the whole SVHC concentration in one finished product, then to evaluate
whether it‘s up to 0.1% (W/W)》 Step-3 -- summarize SVHC concentration for EU import
to evaluate the whole export output of SVHC
if > 1ton per year ���� Notification
Microsoft Word
Document
REACH – SVHC testing
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REACH
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REACH – Obligation of articles
� Market influence the safe use
information
should be
provided within
45 days after
receiving
request from
consumer
Letter cc to
ECHA
(European
Chemicals
Agency)
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REACH – Obligation of articles
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Examples of intended release:
Release of ink from felt tip pens (function = writing, requires the release of the ink from the pen)
Release of detergents from cleaning wipes for glasses (function = cleaning, the release of detergents contributes to the
cleaning function of the wipes)
„Intended released substances“
Substances may be intended to be released from articles in order to
provide an „added value“ where this accessory function is not directly
linked to the main function.
REACH – Obligation of articles
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� Declaration letter for REACH complying
• BOM list & relevant MSDS of materials / components
• SVHC testing report
• SVHC concentration in articles / finished products
• other chemical substances‘ information
� Registration: for if intended released substances
� Notification: for if SVHC >0.1% & with 1ton per year export
tonnage
REACH – requirements to article suppliers
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� Document information for Notification
• substance name: DEHP (SVHC substances)
• CAS. No:117-81-7
• registration no: xxxxxx
• category (hazard pre-caution): cat-2
• exposure control (safe information):xxxxxx
Di(2-ethyexyl)phthalates
(DEHP) is detected in
black sole
REACH – relevant information for notification
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� Importer’s Decision:
• Avoid the obligations of Notification
• Control / Prevent any SVHC in article over limit of 0.1%
• Prepare SDS for necessary preparations / intended-released
substances from article
� TUV services to support Importers & Suppliers
1. SVHC screening according to the updated chemical list published
by ECHA
2. Comprehensive screening for other kinds CMR cat.1&2 chemicals
(with ref. to the list of Appendices 1-6 of REACH Regulation)
3. Preparation of Safety Data Sheet (SDS)
REACH – requirements to article suppliers
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REACH
information
collection
REACH
Testing
QC controlling
of Suppliers
REACH
Fulfilling
REACH – requirements to article suppliers
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REACH – declaration for REACH compliance
Risk could be share but
it is not reduced �
Referen
ce version
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Another suggestion to control the risk of REACH SVHC:
– BOM list as for quality control from suppliers BBB companyYellowPigmentPaint 2 ------------------------7
------------------------6
CCC companySilvery Metal Enclosure5
DDD companyTransparentGlassDoor4
CCC companySilveryMetalLock 3
AAA companyRed / black / etc.PigmentPaint1
SupplierColorMaterialPart NameNO.
A new service from TUV Rheinland
-- central IT system as supporting
REACH – declaration for REACH compliance
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TÜV Rheinland Compliance Platform
SuppliersSuppliers
Output
Analyze,
Report
Upload
ManufacturesManufacturesClientsClients
BOM build,
Design
Request
Monitor, Manage & Conduct Analysis
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� Rough procedure for REACH compliance
1. REACH
BoM list
� To set up a
material controlling
system
2. REACH
SVHC evaluation
�To calculate
SVHC
concentration of
each components
3. REACH
compliance
�SVHC by
product weight
concentration
� Composition list
for metal
components
� “intended-to-be-
release”
substances
� MSDS
4. REACH
declaration
� REACH
Declaration
Letter for
REACH
complying
5. REACH
supplier chain
management
� REACH data
base
�Risk
evaluation
�IQC
�QC system
updates
Information Collection
Assessment Management
REACH – requirements to article suppliers
16.09.2011 Greater China Softlines
REACH
� What is REACH?
- regulation for chemical substances
� Who to be responsible for / involved in REACH?
- be responsible: ECHA
- be involved: manufactures / representative / distributors / importers /…
� How to implement REACH in EU market?- market control & buyers’ requirements
� How to fulfill REACH SVHC requirement?
- SVHC notification / documents provided within 45 days / …
� How to comply REACH for manufactures?- materials data base (MSDS) / SVHC test / declaration letter /
material quality control (REACH BOM) / supply chain management / …
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Softlines-Materials
Ms. Carol Cai电话电话电话电话:::: 020----2839 1888 ----1405E-mail: [email protected]
Contact us!
Thanks !!!!