Thursday 5th March 2014
Panellists/Speakers:
Chaired by Sebastian Charles
Dr Aidan Turnbull
Bruce A Gordon
Raminta Dereskeviciute
© Copyright 2014 by K&L Gates LLP. All rights reserved.
EU REACH, RoHS, WEEE,
Batteries and Packaging
Legislation - Recent Developments
and Compliance Issues
1
AGENDA
 Chaired by Sebastian Charles, Partner, K&L Gates LLP
 Enforcement of WEEE, RoHS and REACH in the EU
and the UK: case studies, responsibility of actors in the
supply chain, ensuring compliance - Raminta Dereskeviciute,
Senior Associate, K&L Gates LLP
 Business benefits for suppliers to use BOMcheck for
substance declarations (REACH, RoHS2, etc) and
Conflict Minerals - Dr Aidan Turnbull, BOMcheck.net, Director, Environ and
Bruce A Gordon, Principal, Environ
 ENVIRON outsourced compliance management services
for EU WEEE, Batteries and Packaging - Dr Aidan Turnbull,
BOMcheck.net, Director, Environ and Bruce A Gordon, Principal, Environ
klgates.com
2
Enforcement of WEEE, RoHS and
REACH in the EU and the UK
by Raminta Dereskeviciute
© Copyright 2014 by K&L Gates LLP. All rights reserved.
OVERVIEW: WEEE, ROHS II AND REACH
 How does the EU legislation apply?
 National law of each Member State (‘MS’) specifies enforcement
authorities, offences and penalties
 WEEE and RoHS II are directives implemented via national legislation of each MS and
implementation may vary
 REACH is a regulation that is directly applicable in every MS (i.e. MS can require
parties to comply without having to implement REACH into national law) but MS
authorities are responsible for determining penalties
 What is required for compliance?
 Self-declaration
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registration
CE markings
declarations of conformity
conformity assessments
wheeled bin symbol (WEEE)
klgates.com
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WHY DOES IT MATTER?
 Criminal offences for non-compliance
 Penalties may be applied to directors/ management
 Interruption of business
 Manufacture
 Import
 Trade
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Invalidated insurance cover
Defective product claims
Reputational risk
Contractual liabilities
Revocation of trade licences
klgates.com
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OVERVIEW: EU PENALTIES
 Penalties are a matter for MS authorities to determine,
which leads to different levels of fines
 Penalties must be effective, proportionate and
dissuasive
 Criteria to be considered
 Seriousness of offence
 Environmental harm/scope
 e.g. if offence is minor and committed for first time authorities
may issue warning for corrective action
 Report on penalties applicable for infringements on the
provisions of the REACH Regulation in the Member
States has been issued by the European Commission
(‘EC’)
klgates.com
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OVERVIEW: EU PENALTIES
For administrative penalties, the level of fines varies.
Criminal sanctions may apply.
 WEEE
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Denmark: unlimited fine for companies, up to two years’ imprisonment for individuals
France: fine €2,250 to €7,500 for companies, €450 to €1,500 for individuals
Germany: fine €10,000 to €50,000
Italy: fine €150 to €100,000
 RoHS II
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Denmark: unlimited fine for companies, up to two years’ imprisonment for individuals
France: fine €7,500 for companies, €1,500 for individuals
Germany: fine €10,000 to €50,000
Italy: fine €50 to €100,000
 REACH
 Generally €50,000 to €1m fine for the first infringement
 Belgium: €55,000,000 fine
 UK: unlimited fine
klgates.com
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WEEE OVERVIEW
Source: http://ec.europa.eu/environment/waste/weee/pdf/faq_weee2.pdf
klgates.com
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WEEE: RECENT DEVELOPMENTS TO
SCOPE OF EEE
 Open scope
 Scope currently ten categories of EEE
 From 15 August 2018 scope will be extended to include all EEE
within six broad categories
 Photovoltaic panels from 14 February 2014
 Review by EC of proposed open scope by 14 August
2015
 Additional exclusions from 15 August 2018
klgates.com
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WEEE: WHO IS RESPONSIBLE IN THE
SUPPLY CHAIN?
 Producers
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Register and join producer compliance scheme
Financial obligations
Mark products with crossed out bin symbol
Provide information on WEEE reuse and treatment
Provide registered producer number to distributors
Keep records of EEE placed on market
Encouraged to improve design of EEE
 Distributors
 Take back obligations
 Record keeping for WEEE returned
 Make information available on treatment of WEEE
klgates.com
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WEEE: WHO IS RESPONSIBLE IN THE
SUPPLY CHAIN?
 Scheme operators
 Be approved by environment agency
 Register members
 Report member information to authority (registration, EEE put on market, WEEE
collected at designated collection facility and delivered to approved authorised
treatment facility)
 Arrange for WEEE to be cleared/ treated
 Get evidence to show obligations are discharged
 Pay compliance fee where evidence is insufficient
 Submit declaration of compliance
 Retain records
 Establish systems to identify products for re-use
 Distance sellers viewed as producers so must register
 Must appoint authorised representative if selling in MS to another MS
 May appoint authorised representative if selling outside EU to MS
klgates.com
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WEEE: UK OFFENCES AND PENALTIES
 WEEE Regulations 2013 (in force from 1 Jan 2014)
 Criminal offences punishable by unlimited fines
 Producer/ authorised representative: fail to comply with obligations, furnish
registration etc information that is false/ misleading, or false/misleading
declaration of compliance
 Scheme operator: fail to comply with obligations, furnish report with false/
misleading information, false/misleading declaration of compliance
 Distributor: fail to take back
 AATF operator: fail to comply with obligations, furnish report with
false/ misleading information
 Person: fail to comply with financing obligations/ issuing evidence
notes for approval of AATF
 Can apply to companies, unincorporated and partnerships
 Any officer of a company is liable to be proceeded against if offence
is committed with his or her consent/ connivance or attributable to
his or her neglect
klgates.com
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WEEE: UK ENFORCEMENT
Environment Agency
 Enforces regulations so far as they relate to producers, producer
compliance schemes and treatment facilities
 Maintains a public register
 Publishes information on WEEE
 Monitors producers and scheme operators
 Approves scheme operators and exporters
 Can serve enforcement notices
 Powers of entry and inspection
Vehicle Certification Authority
 Enforces distributor obligations (take back) and requirements to mark
products with crossed out wheeled bin symbol
 Powers of entry and inspection
 Mystery shoppers and inspectors report to VCA
WEEE: CASE STUDIES
 Largest UK fine so far
 Eight individuals and three companies
 Ordered to pay £220,000 in December 2012
 For illegally exporting 450 tonnes of broken hazardous WEEE from
the UK to Nigeria, Pakistan and Ghana
 US NGO Electronics TakeBack Coalition
 In February 2014 highlighted problem of collectors of WEEE
exporting it to developing countries and/ or using it for low road
processing
 Happening in EU despite WEEE Directive
 More enforcement is needed
klgates.com
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WEEE: INTERPRETATION BY MS
 Does prototype fall within the scope of WEEE Directive?
 Blue book: “...responsible for designing and manufacturing a
product with a view to placing it on the Community market...”
 UK v German interpretation
 Is there a de minimis threshold for tonnage?
Exemptions?
 How much information to include in the user manual? Is
website enough?
klgates.com
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WEEE: HOW TO COMPLY IN THE UK
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Producers
 Register with producer compliance scheme, pay registration fee, report weight of EEE placed
on UK market each year to scheme operator and whether EEE use is household or business
(see list of approved compliance schemes on environment agency’s website)
 Give producer registration number to anyone distributing/ selling your equipment)
 Consider what will happen to your WEEE and financing obligations involved
 Mark products with crossed out wheeled bin symbol
Distributors:
 Take back obligations
 Join distributor take back scheme run by Valpack Retail WEEE Services Ltd
 Offer in-store take back
 Provide alternative take back service (e.g. make arrangements with PCS)
 Take back free of charge of very small WEEE (>25cm external dimension) if there is an EEE
sales area of 400m2 or more
 Make information available on take back scheme (posters, leaflets etc)
 Log WEEE items returned
 Train all staff to ensure they understand the obligations under the regulation –
mystery shoppers expect all personnel to be informed
klgates.com
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ROHS II OVERVIEW
Source: http://ec.europa.eu/environment/waste/rohs_eee/pdf/faq.pdf
klgates.com
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ROHS II: RECENT DEVELOPMENTS
 MSs had until 3 January 2013 to implement RoHS II
 Transitional provisions: substance restrictions gradually
extended to new product categories
 From 22 July 2014 to 23 July 2019 concerning categories of EEE
 Cables, spare parts for the repair/reuse/updating of
functionalities/upgrading of capacity for specific product category
must comply from the same date as their product category
 Reviews of RoHS: first review by July 2014 of list of restricted
substances
 EC is proposing to restrict five further substances in Annex II:
hexabromocyclododecane (HBCDD) and phthalates DEHP, BBP, DBP and
DIBP
 Will also address development of a methodology for future amendments to
list of restricted substances
 EC to set up working group for substance review
klgates.com
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ROHS II: WHO IS RESPONSIBLE WITHIN
THE SUPPLY CHAIN?
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Manufacturer
 Must not place EEE with restricted substances on market
 Technical documentation, conformity assessment, declaration of
conformity, CE marking
Distributor
 Verify CE marking and technical documentation
 Ensure manufacturer and importer have complied with their obligations
Importer
 Only place RoHS compliant products on market
 Ensure manufacturer has complied with its obligations
Authorised Representative (may be appointed by manufacturer’s written
mandate)
 Keep technical documentation and declaration of conformity available
 Cooperate with authorities
klgates.com
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ROHS II: UK OFFENCES AND PENALTIES
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Implementing Legislation: RoHS Regulations 2012
Criminal offences punishable by unlimited fines
Different actors in the supply chain can incur penalties
For an offence committed by a company - director, manager,
secretary or officer may be prosecuted.
 As an alternative or in addition, the court may in some
circumstances order the person convicted of the offence to remedy it
and reinforce the authority’s costs of investigating the offence
 ‘Due diligence’ defence – if a person can show, subject to certain
conditions, that he took all reasonable steps and exercised all due
diligence to avoid committing the offence
klgates.com
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ROHS II: UK ENFORCEMENT
 National Measurement Office (NMO) may enforce by:
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Making test purchases
Exercising powers of entry to premises
Obtaining warrants
Requiring production of compliance information
Inspecting processes, documents, products
Seizing and detaining products
Issuing a compliance enforcement notice requiring action to be taken
Issuing a recall notice
klgates.com
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ROHS II: UK CASE STUDIES
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NMO regular market surveillance projects to assess RoHS compliance
Will contact companies by letter to respond to RoHS response form within
28 days
Responses allocated to enforcement officers who may contact company for
further information
Visit or contact companies to offer advice and support on compliance
 Household appliances: March 2012 – one business improvement plan required,
two warning letters issued, £11,000 of non-compliant products prevented from
being placed on the market, 30 items seized, eight site visits
 Gadgets and Novelty Equipment: May 2012 – three investigations and £7,500 of
stock removed from market
 Souvenirs and Gifts: March 2013 – NMO attended one company to inspect
paperwork and then closed the matter
 Shower and Sensor Tap: April 2013 – one warning letter issued
klgates.com
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ROHS II: HOW TO COMPLY
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CE marking
Analyse components or materials used in suppliers’ products. Verify supplier
declarations or establish presence of restricted substances
Work closely with manufacturers and suppliers of components to ensure
that finished products do not contain restricted substances above permitted
quantities
Integrate compliance with RoHS II into company’s larger environmental
efforts
Update IT systems to collect data
Provide staff training
Consider provisions in contracts with suppliers
Consider requirements of conformity assessment
Onus is on the manufacturer/ importer/ distributor/ responsible person to
ensure compliance or that an exemption applies
Be aware of EC powers to extend restricted substances and transitional
provisions until 2019
klgates.com
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ROHS II AND REACH
 RoHS applies only to articles (EEE), whilst REACH is broader
 Ongoing discussion as to how MS interpret “article”
 The definition of article under REACH is different from homogeneous
material in RoHS (important with respect to the 0,1% threshold)
 RoHS has a mandatory CE mark and conformity declaration, whilst
REACH doesn't
 The list of REACH substances with restrictions (Annex XVII and SVHC
Candidate List) is growing, RoHS lists a smaller number of restricted
substances (in Annex II) that can also be added to
 Caracal (Competent Authorities for REACH and CLP group) is currently
addressing overlaps between REACH and RoHS
 Suggested by industry professionals that methodology used to assess
future RoHS restrictions must align with REACH assessments
 Further developments expected
klgates.com
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REACH: RECENT DEVELOPMENTS
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Interaction with RoHS (see above slide)
Phase-in of REACH until 1 June 2018
Extension of REACH to nanomaterials
 EC impact assessment on amending the annexes of REACH to take better
account of nanomaterials
 Meeting of MS experts and other stakeholders in March 2014
 Proposals presented to the REACH Committee around summer 2014
 Annexes of REACH could be amended by the end of 2014
klgates.com
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REACH: WHO IS RESPONSIBLE IN THE
SUPPLY CHAIN?
 Suppliers (importers and manufacturers):
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Must register substances in quantities greater than one tonne per year with ECHA
 Submit dossier of relevant information on each individual use of a substance (include
chemical safety report if <ten tonnes p/a)
 Deadlines according to new or existing substances, volume and hazardousness
Safety data sheets to be provided to recipients of substances
 Downstream users (companies/ individuals who use a substance):
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Provide information on uses of substances to suppliers so suppliers can use information in
registration dossier for ECHA
Produce their own dossier and risk assessments, register information with ECHA if not
covered by supplier’s registration dossier
Implement safety and risk management measures specified by suppliers and pass
information to customers on safe use
Inform suppliers on new information on hazards of the substance
Comply with authorisation conditions or restrictions
klgates.com
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REACH: ENFORCEMENT
 ECHA forum (Forum for Exchange of Information on Enforcement):
 Coordinates a network of MS authorities responsible for enforcement
 Not an enforcing authority but work has important influence on enforcement
 May reject registration of substances
 May ask authorities to enforce on its behalf
 REACH EN force
 Report December 2013 on obligations of downstream users –
formulation of mixtures
 Based on reports of 1,181 inspections throughout Europe from 2011 –
2012
 Recommendations made to ECHA forum, ECHA, industry and
enforcement authorities/ inspectors
 REACH Information Portal for Enforcement (RIPE)
klgates.com
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REACH INFORMATION PORTAL FOR
ENFORCEMENT (RIPE)
 Web-based portal enabling national enforcement authorities to
access information submitted to ECHA so that they can
effectively enforce REACH
 e.g. Was a dossier submitted, by whom and when?
 Expected to be used by 2,500 inspectors but not available to
public
 Aims to improve competitiveness of compliant chemicals
industry
klgates.com
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REACH: UK OFFENCES AND PENALTIES
 Implementing Legislation: REACH Regulations 2008
 Criminal offences punishable by unlimited fines
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Contravening provision of REACH
Causing/ permitting another person to do so
Obstructing enforcement authorities
Providing false statements
Failing to provide information when requested
 Enforcement authority may bring civil proceedings for such remedy
as is appropriate if a criminal sanction would not work
klgates.com
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REACH UK ENFORCEMENT
 Health & Safety Executive (HSE)
 Enforces registration and supply duties up to the point of retail sale
 Local authority trading standards departments responsible for consumer
protection issues
 Environment Agency, HSE and local authorities
 Enforce use-related duties, as per existing arrangements for enforcing
health, safety and environmental legislation (Health and safety at Work etc
Act 1974, Environment Act 1995)
 UK Border Agency
 May detain goods at import for two working days on request/ if it has
reasonable grounds to suspect that goods are in breach of REACH
 HM Revenue and Customs
 May disclose information obtained or held in the exercise of its functions
relating to imports to facilitate the exercise of a duty of the above
klgates.com
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REACH: LEGISLATIVE DEVELOPMENTS
 EU Waste Framework Directive and REACH interaction
 In March 2013 CJEU decided that it is for each national court to decide whether
hazardous waste had ceased to be waste based on REACH and WFD
requirements
 Particularly, it is for the national court to consider whether a substance met the
requirements for derogation from Annex XVII or REACH
 EU REACH Committee has voted to add nine substances to
authorisation list
 Substances added to Annex XIV will require authorisation for use
 By 2019 substances will be banned unless authorised
 Adopted proposal from EC to update test methods regulation by adding Eogrts
and five other tests to test methods
 Reduces use of animals in REACH tests
 Committee to agree amendments to Annexes VIII to X to stipulate data
requirements
klgates.com
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REACH: HOW TO COMPLY
 Designate “person in charge” and ensure everyone knows
who that person is
 Centralize all relevant information electronically
 Keep all documentation retained as hard copies together
 All confidential documents should be marked as such
 Prepare a checklist of all documents and where they are kept
 Update the information on a regular basis
 Ensure relevant people know where and how to access
information
 Prepare a “to do” (and “not to do”!) list for on-site inspection
klgates.com
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REACH: HOW TO COMPLY
 Keep information for 10 years after last
manufacture/ import/ supply/ use
 Must be available (hard copy or electronic)
 Keep information available on site regarding
operations
 Provide information on administrative and
regulatory matters within a reasonable time if
requested
 REACH audit
 Assessment of company’s operations
 Risk management
 Review of response readiness to demonstrate
compliance to relevant authorities in the event of an
investigation
 Assessment of the operations of a target company
in an M&A scenario (due diligence)
klgates.com
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REACH: HOW TO COMPLY
 Compliance review
 Review of compliance documents
 Mock inspections
 Incident handling
 Training
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On legislative requirements
Best practice workshops
How to respond to an inspection
Is your contamination risk assessment viable?
Insurance coverage assessment
Insurance/ risk mitigation
klgates.com
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CONTACT US
Raminta Dereskeviciute
+44 20 7360 8264
raminta.dereskeviciute@klgates.com
Sebastian Charles
+44 20 7360 8205
sebastian.dereskeviciute@klgates.com
klgates.com
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SPEAKER: RAMINTA DERESKEVICIUTE
REACH Experience

Advising the metals / chemicals industry and related associations on numerous aspects of REACH and CLP:

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REACH consortia formation;
Identification of chemical substances which are subject to registration;
Late registration, data sharing and disclosure of test data. Participation in a SIEF
Authorisation and restriction procedures and related requirements;
Relations with downstream users and distributors;
Advice on EU Regulation on classification and labelling of chemicals.
Challenging ECHA’s and EC’s decisions before ECHA's Board of
Appeal, the General Court and the Court of Justice of the European Union
Was engaged in drafting the Implementation Guidelines for REACH Regulation on Data
Sharing (RIP 3.4)
Contributor to first REACH book to practitioners “REACH – Best Practice Guide to
Regulation (EC) No 1907/2006”
Speaker in numerous conferences on REACH, CLP and chemical legislation around the
world
Other Experience
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Compliance with WEEE, RoHS, Water Framework Directive, Waste Directive, Seveso
Directive, Batteries Directive
EU Raw Materials Initiative
Transport of dangerous goods, including ADR and IMDG
Emissions trading scheme and renewable energy, including CRS Energy Efficiency Scheme
klgates.com
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Compliance management services for WEEE,
Batteries and Packaging
Leading international environmental
and life sciences consultancy
• Established 1982 by former advisors to US
President Carter
25 offices
Europe/Russia
49 offices
• 1,500 staff
North America
• 88 offices
• 19 countries
• 5,000 client
engagements
per year
• $280m revenue
3 offices
1 office
in 2012
South America
3
Africa
9 offices
China/Asia
Pacific
Experience and expertise
• UK Government (DTI/DEFRA) RoHS & WEEE Guidelines, 2003
• Web-based system to manage B2B WEEE compliance in EU Member
States www.b2bweee.com, 2005
• First organisation to gain licence to operate a WEEE compliance
scheme in the UK www.b2bweee-scheme.com, 2007
• Wrote several Joint Industry Statements for EU Medical Device
Industry and represented MD Industry at European Commission
• Outsourced compliance management services for WEEE, Batteries
and Packaging regulations in EU Member States, 2009
EU product environmental regulations
Recycling requirements
• Packaging Directive (as
amended) 94/62/EC
• WEEE Directive 2002/96/EC
(WEEE Recast 2012/19/EU)
• Batteries Directive 2006/66/EC
Substance regulations
• RoHS Directive 2002/95/EC
(RoHS2 Directive 2011/65/EU)
• REACH Regulation 1907/2006
Challenges for WEEE, Batteries, Packaging
compliance
• 3 Directives with national variations and
differing requirements in 28 EU Member
States
• Other European countries (e.g. Iceland,
Norway, Switzerland) also have WEEE,
Batteries and Packaging regulations
• Companies may lack internal resources
to understand and manage different
compliance requirements for WEEE,
Batteries and Packaging in each EU
Member State where products are sold.
• WEEE, Batteries and Packaging
regulations in EU 28 continue to change
as new requirements are implemented
Waste Electrical and Electronic Equipment
(WEEE) Directive 2002/96/EC
ENVIRON’s WEEE compliance (B2B and B2C)
Services
• Assessment of client products /sales
arrangements to identify EU WEEE
producer responsibilities
• Pan-European web-based WEEE
Compliance Systems to manage and
communicate legally robust B2B
collection and recycling arrangements
in EU 28 (www.b2bweee.com)
• Recommend compliant B2C WEEE
collection, treatment and recycling
options in EU 28
• Management of WEEE producer
registration and reporting to WEEE
Regulatory Authorities in EU 28
Batteries Directive 2006/66/EC
ENVIRON’s Batteries Compliance Services
• Assessment of client sales arrangements to identify
batteries producer responsibilities
• Identify battery type, weights and chemistries as required
to register as a batteries producer in EU 28
• Calculate client battery obligations in each country based
on sales
• Provide advice on battery collection, treatment and
recycling options in EU 28 Member States
• Join batteries compliance schemes and pay registration /
battery recycling fees on behalf of client
• Re-calculate and report client battery obligation each year
• Advise on Article 11 Design for Removability requirements
47
Packaging Directive 94/62/EC
ENVIRON Packaging Compliance Services
• Assessment of client sales arrangements to identify Packaging
producer responsibilities in all 28 EU Member States
• Recommended compliance action plan for each EU 28 country
• Establish compliance arrangements for packaging (or audit
client’s existing packaging compliance arrangements),
including:
– Recommend the most cost-effective and reliable packaging
compliance scheme in each country
– Calculation of weight of packaging to report to the packaging
compliance scheme in each country
– Calculation of packaging recycling fees payable in each country
ENVIRON Packaging Compliance Services
• Join / manage membership of
approved packaging
compliance scheme in each
country and pay registration /
packaging recycling fees on
behalf of client
– fees invoiced to client at cost
• Re-calculate packaging
obligation each year and report
packaging obligation to
packaging compliance
schemes.
We can help you ensure compliance
across Europe at the lowest cost
• Identification of your company’s obligations for WEEE,
Batteries and Packaging across all 28 EU Member States
• Detailed compliance action plan for each country, as required
• Assist your company to become fully compliant in each
country, including:
– Calculating your company’s WEEE, Batteries and Packaging
obligation in each country
– Recommending the most cost-effective and reliable recycling
arrangements / compliance scheme in each country
• We calculate and compare the registration and recycling fees you
would pay by joining different schemes in each country
• We can also audit your existing WEEE, Batteries and Packaging
compliance arrangements to advise whether you are getting
best value at lowest cost
We can pay your registration and
recycling fees and invoice you at cost
• We can join your company to
approved compliance schemes
in each country and pay the
registration and recycling fees
on your behalf
– We will invoice you for the actual
registration and recycling fees
• We can re-calculate your WEEE,
Batteries and Packaging
obligation each year and
manage your regulatory
reporting and compliance
scheme membership
– We will invoice you for the actual
membership and recycling fees
Without ENVIRON’s compliance
management services ....
With ENVIRON’s compliance
management services
www.b2bweee.com
Compliance management services for WEEE,
Batteries and Packaging
Business benefits for suppliers to use BOMcheck
tools to make declarations for REACH, RoHS2
and Conflict Minerals
Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
5 minute video explains REACH Candidate List
requirements to Siemens suppliers
• Released May, 2012
• Explains why Siemens encourages suppliers to provide Full Material
Declarations (FMDs)
• To view the video, visit the Siemens website here:
https://w9.siemens.com/cms/supply-chain-management/en/supplier-atsiemens/basic-information/environment/product/Pages/stewardship.aspx#
…and select this link
Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
October 2007: Siemens invited ENVIRON
to build BOMcheck
 Siemens and ENVIRON consulted leading OEMs to develop the
technical specification and business plan
– ENVIRON built a pilot system for testing
– Siemens encouraged other OEMs to join the Industry Steering Group
 EU Trade Association COCIR launched BOMcheck, May 2008
– COCIR membership includes GE, Siemens, Philips, Toshiba, Hitachi,
Agfa, Intel and several other global electronics companies
– Praised by European Commission
“BOMcheck is the first system that allows OEMs to reduce the
industry burden of REACH and RoHS compliance by compiling a
centralised master database of substance data from suppliers”
Dr Freimut Schröder, Siemens Healthcare and
COCIR Environmental Policy Focus Group chair
What type of organization should develop
and manage this database for OEMs?
 Independent company with no conflicting business interests
 Established international offices and sufficient resources
 Expertise in environmental product regulation
 Experience in providing web based systems
 International reputation with Regulatory Authorities
Independent expert on environmental regulations
with extensive experience of web-based systems
UK Govt. (DTI/DEFRA) RoHS & WEEE Guidelines
Web-based system to manage B2B WEEE compliance in
multiple Member States. First organisation to gain WEEE
compliance scheme licence in the UK
2003
www.B2BWEEE.com
www.B2BWEEEScheme.com
Wrote several Joint Industry Statements on RoHS and
WEEE for EU Medical Device Industry and represented
Industry at RoHS negotiations with the European
Commission
Joint Industry Guide to REACH compliance for component
suppliers & equipment manufacturers
2005
2007
2008
available free from
www.BOMcheck.net
2008
Co-Chair of IPC 1752A Standard for Materials
Declarations
2010
UK National Expert and European Regional
Coordinator for IEC 62474 Standard. Helped write EN
50581 Standard for RoHS2 Technical Documentation
2012
Centralised shared web database designed
and directed by industry
BOMcheck Steering Group
 Siemens, Philips, GE, Osram, Sony Mobile, Schneider Electric, Toshiba,
Agfa, Texas Instruments, TE Connectivity, FUJIFILM
 Web meeting / conference call every 2 months:
– Direct development of new functions and features on BOMcheck
– Coordinate joint activities to engage suppliers (workshops, trainings etc)
BOMcheck Substance List Working Group / VT 62474
 Siemens, Philips, GE, Osram, Sony Mobile, Schneider Electric, Agfa,
Bayer, Toshiba, Texas Instruments, TE Connectivity
 Web meeting / conference call every 2 months to:
– Maintain one BOMcheck list of restricted and declarable substances
– Update list as new substances added to REACH, etc
More than 570 companies use BOMcheck
… to gather materials declarations from over 3,500 suppliers for more than
1.6 million parts
Supplier account = €300/year
Access to BOMcheck guidance and
declarations tool to generate and
maintain substance declarations
for part numbers you supply to
your customers
‘Super User’ Account
Manufacturer account = free
Access to download all declarations
data, e.g. for part numbers
you buy from your suppliers
Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
Conflict Minerals Legislation
 In July 2010, U.S. Congress signed into law the Dodd–Frank Wall Street
Reform and Consumer Protection Act
– Section 1502 includes ‘conflict minerals’ reporting requirements for SECreporting companies (US publicly traded companies)
 SEC Final Rules published August 2012
– Conflict minerals defined as Tin, Tungsten or Tantalum which has been
smelted, and Gold which has been refined, after 31 Jan 2013. Commonly
known as 3TG metals
– Reporting requirements expected to impact directly about 6,000 SEC
reporting companies and indirectly all of their suppliers
– Companies must report annually whether they are “DRC conflict free” or “Not
DRC conflict free”. Can declare “DRC conflict undeterminable” for up to 2
years (up to 4 years for small companies)
Is your company in scope?
1.
Are you an SEC-reporting company?
2.
Are 3TG metals “necessary to the functionality or production” and
intentionally added and contained in a product you manufacture, or
contract to be manufactured?
–
3.
No ‘de minimis’ levels or exemptions for small companies
If yes, then conduct a Reasonable Country of Origin Inquiry to
determine if 3TG metals do not originate from DRC region or are from
recycled or scrap sources (which are also treated as conflict free)
–
Disclose results on company website and file Conflict Minerals Disclosure
Form SD with SEC each year
–
If 3TG may originate from DRC region, then conduct due diligence on
conflict free status and file additional Conflict Minerals Report
Industry compliance approaches
 EICC GeSI Conflict Minerals Reporting Template
– Standardized collection of information from suppliers
– Enables manufacturing companies to carry out supply chain RCOI
to identify the smelters for 3TG metals in their products
 Conflict-Free Sourcing Initiative Conflict-Free Smelter Program
– Independent, third-party audit tool with a compliance protocol that
determines which smelters can be validated as “conflict-free”
 ITRI Tin Supply Chain Initiative (iTSCi)
– ‘bagging and tagging’ program in DRC region to trace minerals from
the mine to the smelter
First fully integrated Conflict Minerals
and RoHS, REACH web database
 Extensive feedback on data management challenges with other web
platforms has helped industry develop the first web database which:
√ Provides one integrated tool for suppliers to upload their EICC GeSI Conflict Minerals
Reporting Templates at the part level or company level at the same time as they
publish materials declarations for RoHS, REACH and other regulated substances.
√ Validates the data in the supplier’s EICC GeSI Conflict Minerals Reporting Template
and provides immediate detailed feedback to the supplier on how to correct any data
validation errors which are preventing upload.
√ Works in partnership with the Conflict-Free Sourcing Initiative to validate any new
smelters which suppliers identify so that they can be added to the smelter list and
invited to join the Conflict-Free Smelter Program.
√ Enables manufacturers to leverage the Conflict-Free Smelter Program and the
upcoming EU Responsible Sourcing Regulations to work towards “DRC conflict free”
status by 2015.
BOMcheck data validation and
detailed feedback to suppliers
 Company pilot programs took an average of 3 or 4 interactions with
suppliers to achieve complete and coherent EICC GeSI Conflict
Minerals Reporting Templates.
 BOMcheck Industry Steering Group shared the results from their pilot
programs to develop a comprehensive set of data validation checks and
error messages.
 BOMcheck carries out these data validation checks automatically
– Provides immediate detailed feedback to the supplier on how to correct any
data validation errors
– Supplier’s EICC GeSI Conflict Minerals Reporting Template must pass all
checks before it can be uploaded and shared on BOMcheck
BOMcheck and CFSI validate ‘new
smelters’ reported by suppliers
 Version 2.03a of the EICC GeSI Conflict Minerals Reporting Template
now includes > 99% of the world’s Conflict Minerals smelters, each
identified with a unique Smelter ID.
 BOMcheck works in partnership with Conflict Free Sourcing Initiative. If
the supplier believes they have identified a potential new smelter then
– Supplier uses BOMcheck to verify basic information with the company
– BOMcheck follows-up with company and uses CFSI Smelter Identification
Questionnaire to collect and check the necessary information to add the new
Smelter ID to the smelter list in the EICC GeSI template.
– BOMcheck provides new Smelter ID for supplier to include in their EICC
GeSI template so that it will upload to BOMcheck
 Conflict-Free Sourcing Initiative will invite the new smelter to join the
Conflict-Free Smelter Program.
Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
EU RoHS2 Substance Restrictions apply to
each homogenous material in the part
 Maximum concentration in any homogenous material in the part
–
–
–
–
–
–
Cadmium/cadmium compounds : 0.01%
Lead/lead compounds : 0.1%
Hexavalent chromium compounds : 0.1%
Mercury/mercury compounds: 0.1%
Polybrominated biphenyls (PBB): 0.1%
Polybrominated diphenyl ethers (PBDE): 0.1%
 Exemptions in RoHS2 Directive
– Annex III exemptions applicable to parts used in any equipment
– Annex IV exemptions only applicable to parts which are exclusively used in
Medical Devices (Cat. 8) and/or Monitoring and Control Instruments (Cat. 9)
•
•
Part numbers which claim Annex IV exemption are shown in orange
Do not select Annex IV exemption if part could be used in other equipment
New RoHS2 technical documentation
requirements for Manufacturers
 Article 7 places new obligations on Manufacturers to draw up
Technical Documentation, carry out internal production controls,
provide EU Declaration of Conformity and affix CE Marking
 Technical documentation of internal production controls shall:
– Specify requirements for product design and manufacture
– Enable assessment of RoHS conformity for the product
 Technical documentation shall, wherever applicable, include:
– A general description of the product
– Bill of materials
– Examinations carried out (i.e. materials assessments, declarations
from suppliers etc)
– Test reports
Guide to Using BOMcheck and EN 50581
for RoHS2 Technical Documentation
 Reviewed by
– European Commission
RoHS2 Working Group
– UK Government RoHS2
Regulators
– UK Government RoHS2
Enforcement Agency
 Available free-of-charge at
www.bomcheck.net/rohs
HOW TO USE SGS BOMcheck SERVICES
TO COMPLY WITH EN 50581:2012
SGS can:
Use BOMcheck to collect
documents from
suppliers which comply
with quality and
trustworthiness
requirements

Risk assess parts list for
product BOM based on
agreed strategy

SGS can train suppliers
to upload their Materials
Declarations to
BOMcheck.

SGS can also
automatically upload any
SGS test report to
BOMcheck for the
supplier if needed.

Review a representative
sample of the suppliers
test reports to verify
against EN 50581
requirements

Prepare SGS RoHS
Assessment Verification
Report
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Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
Six lists of substances in BOMcheck
Regulatory Compliance Declaration tool
Following BOMcheck chemicals guidance for
REACH and other substance regulations
Screen materials for
compliance risk
• Use BOMcheck guidance to identify materials which could
contain restricted or declarable substances. Exclude
materials which don’t have compliance risk.
Ask your materials
expert
• Use BOMcheck detailed guidance to investigate materials
with a compliance risk. Check where substances are used,
trade names, other chemical names and alternatives. Use
FMD tool to check compliance for CAS numbers.
Ask your supplier
• If your materials expert doesn’t know, then use BOMcheck
detailed guidance to ask specific questions to your supplier.
• Attach documentation from your supplier to your declaration
in BOMcheck
Confidential
Divison, MMMM dd, yyyy, Reference
BOMcheck enables suppliers to eliminate 89
REACH Candidate List Substances
 151 substances on the REACH Candidate List (16 December 2013)
 BOMcheck guidance enables supplier to eliminate 89 substances which
are not normally found > 0.1% w/w in materials and parts supplied for
use in hardware products and electrical and electronic equipment
– BOMcheck Substance List Working Group shares chemical knowledge to
decide which REACH Candidate List Substances are not normally found >
0.1% w/w in materials and parts
– Supplier’s Regulatory Compliance Declaration is set to “compliance = Yes”
for these 89 substances
 If supplier answers that they do use substances in a very unusual way
(e.g. trade secret, unique process, etc) then supplier required to
complete all 151 REACH Candidate List substances individually
Materials at risk of containing remaining 62
REACH Candidate List substances
 Lithium ion batteries, ultraviolet lamps, electrolytic capacitors, ultrasound transducers,
ceramic capacitors and actuators
 Polyurethane
 Plasticisers, flame retardants and stabilisers (e.g. found in plastics, rubber, sealants,
adhesives, textiles, etc)
 Humidity indicators (e.g. silica gels which change colour when they absorb water)
 Glass
 High temperature insulating materials
 Biocides (e.g. to prevent mould growth inside polyurethane foam)
 Wood, paper, cotton and other plant-derived materials
 Yellow and red pigments for plastics and paints
 PVDF Plastic
 Specialist paints and coatings
 Acrylic adhesive glues
Materials and parts that are not listed here do not normally contain
REACH Candidate List substances > 0.1% w/w (exception is trade
secret, unique process etc)
Agenda
1. Background, why OEMs need a centralized database
2. Why ENVIRON was asked to build BOMcheck
3. Integrated Conflict Minerals tools with built-in data validation
4. Materials declarations comply with EN 50581 requirements for RoHS2
Technical Documentation
5. Chemicals guidance for REACH and other substance regulations
6. Resources available for implementing BOMcheck
Supplier training webinars and guidance, tools
in Chinese, Japanese, German and English
 BOMcheck provides monthly introduction webinars for suppliers
– Explains REACH, RoHS, Batteries and Packaging regulations
– Demonstrates how suppliers can make declarations in BOMcheck
– 1.5 hours, free-of-charge, suppliers can attend multiple times
 All suppliers are required to complete the recorded BOMcheck
expert user training when they first login
– Provides step-by-step demonstration of all tools on BOMcheck
 BOMcheck tools, help screens, summary guide and detailed user
guide are available in Chinese, Japanese, German and English
 BOMcheck encourages suppliers to practice on demonstration
site before they make declarations on live site
 BOMcheck helpdesk available 8.00am to 7.00pm European time:
– E-mail: bomcheck@environcorp.com
– Phone : +44 1225 748458

Support services available from Tetra Tech
and Celestica
• Launched in 2004, Celestica’s Green ServicesTM
offering was the first complete product conversion
offering for RoHS compliance.
• Celestica provides supply chain management services to
manufacturers who join BOMcheck and sign a NonDisclosure Agreement for Celestica to use the
manufacturer’s login details on BOMcheck.
• Tetra Tech helps companies achieve their product
compliance goals through technology implementation
and has extensive experience in managing material
compliance projects in the automotive, electronic,
healthcare and aerospace industries.
• Tetra Tech provides BOMcheck – ENOVIA MCC
integration services, consulting services and customised
training services.
Using BOMcheck API to automate data
download to your PLM system
 BOMcheck API exports data in industry standard formats
XML: IPC 1752A International Standard (ENVIRON is co-chair)
CSV (tab separated) using IEC 61906 PAS naming convention
 Partner programme and IT Change Request Control Board
– PTC: connection to Insight/Analytics
– Enovia: connection to MCC
– Siemens PLM: connection to TeamCenter
– Oracle: connection to Agile PLM
– (TechniData: connection to SAP EHSM)
Security arrangements ensure suppliers
data is safe
 BOMcheck contracts include strict obligations on ENVIRON to
ensure security and confidentiality of Member’s Data
– Only 3 Security-Approved ENVIRON staff have Administrator access
– Steering Group companies DO NOT have any special access
 BOMcheck uses same internet servers as www.Amazon.com
 security certifications include SAS70 Type II, PCI
DSS Level 1, ISO 27001, FISMA
 BOMcheck web application security is audited by Siemens Cyber
Emergency Readiness Team (CERT)
 Siemens CERT carry out a 5 day audit each year.
The last audit was completed in January 2012
Business benefits for suppliers to use BOMcheck
tools to make declarations for REACH, RoHS2
and Conflict Minerals
ANY QUESTIONS?
STOP PRESS – CONFLICT MINERALS
 On 5 March 2014 the EC published a Proposal for a
Regulation on conflict minerals due diligence certification
 Importers of tin, tantalum, tungsten, gold and their ores
originating in conflict-affected and high risk areas have the
option of self-certifying as a responsible importer
 Member States will monitor compliance by responsible
importers with obligations concerning management systems,
risk management, third party audit and disclosure
 The Commission will publish a list of responsible smelters and
refiners
 The Regulation must be agreed by the European Parliament
and the Council of the EU before it becomes law
 For further details please ask for our client alert
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 This presentation is for informational purposes
and does not contain or convey legal advice.
The information herein should not be used or
relied upon with regard to any particular facts or
circumstances.
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