Updates Of Certain Chemical Requirements to EU marketchina.ahk.de/uploads/media/20110920_RoHS_REACH_updates.pdf · --CE marking shall be affixed in all EEE or its ... ... with effect

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16.09.2011 Greater China Softlines

Updates

Of

Certain Chemical

Requirements

to EU market


Recast Directive

of

EU RoHS

(2011/65/EEC)

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16.09.2011 Greater China Softlines3

EU RoHS directive


� 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


� 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


� 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)


� Product scope about specific provisions


� 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


� 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


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


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)


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!!


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）


� 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


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.


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


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

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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


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


REACH

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Product evaluation before testing

1. Material disassembling

REACH – SVHC testing



1. Material disassembling


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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 & 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

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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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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.



� 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


� 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)


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REACH

information

collection

REACH

Testing

QC controlling

of Suppliers

REACH

Fulfilling



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


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

� 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!

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Documents

Updates Of Certain Chemical Requirements to EU marketchina.ahk.de/uploads/media/20110920_RoHS_REACH_updates.pdf · --CE marking shall be affixed in all EEE or its ... ... with effect