Assent Compliance hosted a free webinar on January 29th, covering RoHS II Compliance and the changes you will need to implement within your existing RoHS program in order to achieve compliance.
This webinar will address processes and rules to consider when reviewing your current RoHS program for compliance with RoHS II.
The topics of discussion will include:
o Reviewing RoHS
o Reviewing RoHS II
o Changes between RoHS and RoHS II
o CE Marking Implications
o RoHS II Technical Files
o Standards associated with RoHS and RoHS II
o Exemption Expirations
Restriction of Hazardous Substances(RoHS) and REACHAmit Ghai
A historical perspective, current revisions and guidelines for RoHS and REACH compliance. Includes typical case studies, challenges and ways to overcome them
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
ISO 14001 - Environmental Management Systems, the first international standard for the world's environment helps thousands of organizations to improve their environment, sustainability and operational performance. This topic covers workshops and case studies to evaluate effectiveness of training. Each participant needs to solve this case study after undergoing the training. After successful completion of workshops and case study the ISO 14001:2015.
Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances.
Assent Compliance with offices in Canada, US and EU provides consulting services and compliance software to businesses that must comply with local, national or global environmental regulations. Visit Assent Compliance for more information.
Restriction of Hazardous Substances(RoHS) and REACHAmit Ghai
A historical perspective, current revisions and guidelines for RoHS and REACH compliance. Includes typical case studies, challenges and ways to overcome them
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
ISO 14001 - Environmental Management Systems, the first international standard for the world's environment helps thousands of organizations to improve their environment, sustainability and operational performance. This topic covers workshops and case studies to evaluate effectiveness of training. Each participant needs to solve this case study after undergoing the training. After successful completion of workshops and case study the ISO 14001:2015.
Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances.
Assent Compliance with offices in Canada, US and EU provides consulting services and compliance software to businesses that must comply with local, national or global environmental regulations. Visit Assent Compliance for more information.
Matinée organisée par la CCILB afin de faire le point sur les obligations qui découlent du règlement européen REACH, avec Dorothée DUPUIS, conseiller sécurité chez Essenscia.
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements.
This presentation from the Association of Equipment Manufacturers’ provides an overview of what conflict minerals are and where they come from. It also describes the legislation affecting conflict minerals reporting and why everyone in the supply chain is affected.
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
Who needs a CE mark and how do I get one? It is EU law that every product that enters the European Union meet the CE Directives and applicable Standards. This mark can only be applied to your product when you have fully complied with all relevant Directives and Standards for the type of system you are marketing and and a Declaration of Conformity has been developed.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Assent Compliance hosted a free webinar on January 15th, covering the newly released substances on the SVHC list.
This webinar will address the new SVHCs officially added to the candidate list by the ECHA. The topics of discussion will include:
o What are the substances?
o Where are they used?
o A review of what the current Authorization list looks like
o What substances might be included next?
o How can Assent help?
Conflict Mineral Due Diligence and Reasonable Country of Origin Inquiry Matt Whitteker
Reasonable Country of Origin Inquiry and Due Diligence - Conflict Mineral Webinar by Assent Compliance. For more information contact info@assentcompliance.com or visit www.assentcompliance.com
Matinée organisée par la CCILB afin de faire le point sur les obligations qui découlent du règlement européen REACH, avec Dorothée DUPUIS, conseiller sécurité chez Essenscia.
CE marking is a self-declaration where a manufacturer proves compliance with EU health, safety and environmental protection legislation and confirms a product’s compliance with relevant requirements.
This presentation from the Association of Equipment Manufacturers’ provides an overview of what conflict minerals are and where they come from. It also describes the legislation affecting conflict minerals reporting and why everyone in the supply chain is affected.
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
Who needs a CE mark and how do I get one? It is EU law that every product that enters the European Union meet the CE Directives and applicable Standards. This mark can only be applied to your product when you have fully complied with all relevant Directives and Standards for the type of system you are marketing and and a Declaration of Conformity has been developed.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
An Inside Look at Changes to the New ISO 14971:2019 from a Member of the Stan...Greenlight Guru
The 3rd Edition of the medical device risk management standard, ISO 14971:2019, and its companion guidance document, ISO TR 24971:2019, will be published by year-end.
The new structure of the two documents will be presented so that the manufacturer can determine any changes to the risk management system and possibly the quality system that may be required.
These may include simple reference changes in procedures or revision to production and post-production processes that may be required.
Presenter Edwin Bills is an international member of the technical committee, ISO TC 210 JWG1, responsible for the revision of the third edition of ISO 14971 risk management standard.
TALK TAKEAWAYS:
• A detailed look at the new changes to ISO 14971:2019 and ISO TR 24971:2019.
• Reasons for the changes to the latest version
• How to prepare for the coming changes in the standard
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
Assent Compliance hosted a free webinar on January 15th, covering the newly released substances on the SVHC list.
This webinar will address the new SVHCs officially added to the candidate list by the ECHA. The topics of discussion will include:
o What are the substances?
o Where are they used?
o A review of what the current Authorization list looks like
o What substances might be included next?
o How can Assent help?
Conflict Mineral Due Diligence and Reasonable Country of Origin Inquiry Matt Whitteker
Reasonable Country of Origin Inquiry and Due Diligence - Conflict Mineral Webinar by Assent Compliance. For more information contact info@assentcompliance.com or visit www.assentcompliance.com
Conflict minerals scope assessment and compliance planMatt Whitteker
Conflict minerals scope assessment and compliance plan slides that accompany Assent Compliance latest Webinar. Visit www.assentcompliance.com or contact info@assentcompliance.com
Conflict Minerals - Form SD and Conflict Minerals ReportsMatt Whitteker
Assent Compliance replay of latest Webinar: Conflict Minerals - Form SD and Conflict Minerals Reports. Visit www.assentcompliance.com or email info@assentcompliance.com for more info.
Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP and many other environmental regulations. To view the web cast online visit www.assentcompliance.com
Advancing Compliance Assurance and EHS Management Systems Matt Whitteker
At Assent we’re very active in the compliance community. One of the industry associations we are a proud member and sponsor of is The National Association of EHS Managers (NAEM). It is the largest professional community for corporate environmental, health and safety, and sustainability decision-makers. Assent recently attended NAEM’s Advancing Compliance Assurance and EHS Management Systems conference and was able to get some great insights into the topics affecting compliance and EHS managers today. Here was the agenda: http://ehscompliance.naem.org/agenda.php
Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP, Conflict Minerals and many other environmental regulations. To view the web cast online visit www.assentcompliance.com
CI/CD consulting, which stands for Continuous Integration and Continuous Delivery, is a service offered by consulting firms or individuals to help organizations improve their software development and deployment processes. CI/CD is a set of practices and tools that enable development teams to automate and streamline the process of building, testing, and deploying software, ultimately leading to faster and more reliable software delivery.
For More Visit: https://opstree.com/continuous-delivery-automation/
Whether your focus is on making a difference internally or externally, FirstCarbon Solutions offers a complete sustainability solution to help you easily understand and improve your environmental performance so it directly impacts your bottom line.
Service Quality Management - OSS Requirements in SQM ecosystemComarch
Quality expectations of customers are increasing, thus acting as catalyst for changes in service providers’ business models and their approach to overall service quality management. Introduction of SDP and Service Delivery Framework has increased flexibility for easily creating and co-provisioning services, resulting in a more complex end-to-end business case for delivering services. This leads to a situation where managing overall quality becomes a challenge as the single operator plays only a linking role in the long supply chain of the services offered.
EU Conflict Minerals Update -- Amnesty International Report ReviewMatt Whitteker
UPDATE - Due to recent results in the EU Parliament's vote on EU Conflict Minerals, Assent Compliance will be adding a Summary of the decision along with Impacts and Timelines.
Assent Compliance will be hosting a free, 30 minute webinar on Tuesday May 26th, to address the recent EU Conflict Minerals vote and analyze the recently released Amnesty International & Global Witness report called Digging for Transparency.
The EU Conflict Minerals Vote has laid down some drastic changes over the originally proposed Voluntary measures, including:
- Mandatory rules for all 880,000 EU Manufacturer's that use 3TGs
- Global scope that far exceeds the DRC region
Assent Compliance will help you understand the latest on EU Conflict Minerals by addressing the following items:
- Potential Impact of the Rules
- Next Steps
The Amnesty International report makes several claims against industry's efforts towards Conflict Minerals including:
- 80% of companies have failed to meet the minimum requirements of the US Conflict Minerals Law
- Only 16% are going adequately mapping their Supply Chain
- More than 50% of companies do not report risks to Senior Management
This report has set of alarms for many companies impacted by the law and caused them to re-examine their efforts for 2015.
Why Companies Succeed.
Assents CEO presents an insightful look on why companies succeed. Relying on chance alone is not a strategy.
http://www.assentcompliance.com
Reach webinar additional information assent april 2015Matt Whitteker
A possible new interpretation for Articles is on the table but that is not all... There are important lists and annexes associated with REACH compliance that keep updating.
We will review:
• CoRAP - 134 Substance Evaluations
• Restriction Proposal Decisions
• Authorisation Applications
• Registry of Intentions
• Proposed SVHCs
• Recommendations for the Authorization List
We will discuss how these changes affect you and your products. We'll also ensure you know what to focus on and some key tips to practically handle REACH Compliance.
Stock Price and Business Case for ComplianceMatt Whitteker
Assent's latest research paper attempts to clarify the relationship between companies’ environmental compliance strategies, and their profitability (as measured by their stock prices). An independent analysis—performed by two prestigious U.S. institutions: consulting firm Watermark Advisors, and Vanderbilt University’s Owen Graduate School of Management—examined the performance of one hundred publicly traded companies (Assent Customers). As Assent customers, these companies had all invested significantly in their compliance programs.
- Did Their Stock Price Outperform the Market at Large?
- How Much or How Little?
- What Latent Functions Could Investing in Compliance Cause?
- Why Should Companies Invest Vs Do the Bare Minimum?
- What Conclusions Can we Draw About Investing in Compliance.
The European Chemicals Agency (ECHA) updated the SVHC Candidate List on December 17th, 2014. This update added 6 substances to the current substance of very high concern list. This brings the total number of SVHC’s to 161. What does this mean for your products, your company and your compliance team? Assent is hosting a free webinar to examine the full spectrum of implications on Jan 21st, 2015.
CMRT (Conflict Minerals Reporting Template) Data Validation Matt Whitteker
CMRT (Conflict Minerals Reporting Template) Data Validation is the second subject covered in Assents Conflict Mineral 2015 Webinar Series. For information about Conflict Mineral Compliance visit: http://www.AssentCompliance.com
Conflict Minerals Survey -- Tulane University Matt Whitteker
In a follow up survey of companies effected by Dodd Frank Section 1502 Chris Bayer of Tulane university conducted a thorough industry bench-marking survey. The results are broken down in sections:
Profile of affected companies
Internal company resources utilized
External resources utilized
Cost summary
Synergies
Market impact
Good practices
It’s encouraging to note that Assent Compliance was listed as a global top 3 provider of conflict mineral compliance software in terms of adoption rate. A huge thank you to all the Assent customers and suppliers that exchange data on our platform.
You can download the full survey here: Conflict Minerals Survey — Tulane Post Filing
Need a hand with anything compliance related? Email us at Info@AssentCompliance.com
RoHS Exemption List - Review By: Assent Compliance Matt Whitteker
www.assentcompliance.com
Assent Compliance outlines the RoHS exemption list and associated information. Assent Compliance provides companies with RoHS support and software services. If you need a hand with anything compliance related please email info@assentcompliance.com
REACH Regulation - Frequently Asked Questions Matt Whitteker
http:/www.AssentCompliance.com
Assent Compliance examines the frequently asked questions around the EU REACH regulation.
What is REACH?
How does it apply to me?
What are SVHC's ?
Does the REACH List change?
And many other important questions examined. Need a hand with REACH Compliance? Email info@assentcompliance.com
CMRT 3.01 - Comparison To The EICC Gesi Template Matt Whitteker
http://www.assentcompliance.com
Assent reviews in full detail the differences between the CMRT 3.01 (conflict minerals reporting template) and the EICC Gesi template. The CMRT has officially replaced the EICC Gesi as the industry accepted standard. Do you know the difference? Here is the full breakdown.
Need a hand with anything compliance related? Email: info@assentcompliance.com
Conflict Mineral Compliance - Frequently Asked Questions Matt Whitteker
www.assentcompliance.com
Assent Compliance answers the most common frequently asked questions with regards to conflict mineral compliance.
- What are conflict minerals
- What if we are a private company
- What is the difference between the CMRT 3.01 and the previous form
- We do not use 3TG's - What now?
And a host of other FAQ's. If you have any questions about conflict minerals and or conflict mineral compliance email: info@assentcompliance.com
www.assentcompliance.com Assent Compliance looks at psychological mechanisms to improve supplier conversion rates around product compliance and data collection. This unique spin on classic psychology research takes readers through a variety of studies and their application to supply chain. Visit http://www.assentcompliance.com or email info@assentcompliance.com for more information.
Conflict Mineral Compliance Toolkit For Executives Matt Whitteker
Assent Compliance was the only software vendor that the SEC consulted with when passing the Conflict Minerals legislation. Assent has been on the ground floor and has been able to work with over 20% of S&P 500 companies in scope of the law. We've compiled this Ebook to assist with companies that need to comply. This is a play book with everything you need to know. If you want more information visit http://www.assentcompliance.com or email info@assentcompliance.com
Product Compliance Software Vendor Sourcing Guide Matt Whitteker
Choosing a Product Compliance Software / Services Vendor can be a daunting prospect. At Assent we've made things easy with the following guide. We look at best practices, different service, business models and give you an indepth look at how to source a product compliance vendor for software and services.
CMRT 3.01 Different Between EICC - Gesi Form Matt Whitteker
The CMRT 3.01 form has replaced the previous EICC Gesi form for conflict mineral reporting. The CMRT 3.01 is now the industry standard reporting form. This presentation by Assent Compliance outlines the differences between the previous template and the new one. If you need any help with conflict minerals compliance or would like clarification on this document please do not hesitate to contact info@assentcompliance.com or visit at http://www.assentcompliance.com
RoHS II Compliance Presentation - Assent Compliance
1. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
RoHS II Review
Update your RoHS
Information to
Achieve Compliance
Assent Compliance
Krystal Noseworthy-Baker
Regulatory Manager – Key Accounts
613.882.1429
krystal.baker@assentcompliance.com
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
2. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Agenda
• Review of Requirements
• RoHS
• RoHS recast (RoHS II)
• DoCs
• Technical File
• Expiring Exemptions
• Due Diligence and Testing
• Technical File Sample
• Standards associated with RoHS II
• Enforcement
• Q&A
C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
3. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
About Assent
Assent Compliance delivers SaaS Environmental Compliance Services to
companies who must comply with local, national and global environmental
regulations. Assent also supports its software division with a team of highly
experienced industry consultants to provide our clients with turnkey
compliance solutions. Industry experts at Tier 1 companies rank Assent
Compliance amongst the top environmental compliance solutions in the
world and one of the only global solution providers to offer a full service
solution from end to end.
Our Mission
Is to help our clients comply with environmental regulations in the
most efficient and cost effective manner possible. This is achieved
through SaaS automation of processes and working with clients
to build efficient internal compliance programs that meet global
compliance requirements.
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
4. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
How The Assent Compliance
Management System Works
Integrates with
Pulls Bill of Material (BOM) Communicates with Supply
Major ERP/PLM
into a centralized compliance Chain in bi-directional fashion
Systems
data base or operates as a to procure environmental
stand-alone system. information from suppliers
Modules to Comply with
All Major Environmental Build IPC 1752-A FORMS.
Regulations Import/Export via XML
Built-in CRM for compliance
Homogenize proprietary
tasks, due diligence reporting
supplier DOC formats in xml
and audit trails
Allows internal Staff to Acts as a repository for any
Make Engineering Override compliance related material
assessments
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
5. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Consulting Services
Compliance Assessment Services For Environmental Regulations
Internal Standard Operating Procedure Consulting
Compliance Plan Development
Compliance Strategy Consulting
Conflict Mineral Compliance
IT System Integration
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
6. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
our offices
Munich, Germany
london, UK
Ottawa, Ontario Can-
ada (HQ)
Taipei,
Taiwan
Bangalore, India
New York,
New York
Kenya
(Conflict Minerals)
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
7. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
Major Differences between RoHS Recast and RoHS
• Size and Comprehensiveness
• RoHS Recast – Twenty-three (23) pages
• RoHS – Five (5) pages
• CE Marking
• RoHS II is part of the Free Movement of Goods – Regulation 765/2008/EC
• Conformity assessment procedures are affected
• Scope
• Further details given later in the presentation
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
8. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
Major Differences between RoHS and RoHS II
– Key Definition Change
Homogeneous materials and coatings:
• Never mentioned in RoHS
• RoHS II states:
»» Article 4.2: For the purposes of this Directive, no more than the maximum concentration value
by weight in homogeneous materials as specified in Annex II shall be tolerated.
»» Annex II of course details the restricted substances which have not changed:
• Lead (0,1 %)
• Mercury (0,1 %)
• Cadmium (0,01 %)
• Hexavalent chromium (0,1 %)
• Polybrominated biphenyls (PBB) (0,1 %)
• Polybrominated diphenyl ethers (PBDE) (0,1 %)
NOTE: Article 4.2 goes on to state that the Commission is responsible for creating detailed rules for com-
plying with the maximum concentration values for surface coatings
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
9. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
RoHS II Overview
• DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June on the restriction of the use of certain hazardous substances in electrical and electronic
equipment (recast)
• Published in the Official Journal of the European Union: July 2011
• In Effect: July 21, 2011
• Into Member State law: January 2, 2013
• Previous RoHS Directive (2002/95/EC) repealed: January 3, 2013
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
10. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
RoHS II – Categories
1. Large household appliances.
2. Small household appliances.
3. IT and telecommunications equipment.
4. Consumer equipment.
5. Lighting equipment.
6. Electrical and electronic tools.
7. Toys, leisure and sports equipment.
8. Medical devices.
9. Monitoring and control instruments including industrial monitoring and control
instruments.
10. Automatic dispensers.
11. Other EEE not covered by any of the categories above.
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
11. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
RoHS II – Scope
• Medical devices
• Control and monitoring instruments
• Category 11
Now all part of RoHS Recast
• Directive does not apply to:
• 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 specifically military purposes
»» Defense
• Equipment to be sent into space
• Equipment which is specifically designed, and is to be installed, as part of another type of equip-
ment that is excluded or does not fall within the scope of this Directive, which can fulfil its func-
tion only if it is part of that equipment, and which can be replaced only by the same specifically
designed equipment
• Large-scale stationary industrial tools
• Large-scale fixed installations
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
12. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
• 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 applications
• Equipment specifically designed solely for the purposes of research and
development only made available on a business-to-business basis.
»» R&D B2B
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
13. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Review of Requirements
RoHS II – New products in scope
Category 11
TODAY Medical Devices: In Vitro Diagnostic Devices:
(other) Equipment:
29 January 2013 22 July 2014 22 July 2016
22 July 2019
Consumer Monitoring and Professional Monitoring
Control Instruments: and Control Instruments:
22 July 2014 22 July 2017
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Review of Requirements
RoHS II and the CE Mark
• CE Marking Directive
• DoC, Technical File, CE Mark
»» Declaration of Conformity:
• Decision No 768/2008/EC
• Format in the RoHS recast, Annex VI
»» Technical file:
• Module A of Decision No 768/2008/EC
»» CE Mark:
• Directive 93/68/EEC of 22 July 1993
• Subject to Article 30 of Regulation (EC) No 765/2008.
• Applicable to:
»» Finished products in scope of RoHS recast
»» Placed on the market after January 2, 2013
• For those products already under scope of RoHS
• For the new products under scope, the previous slide provides the dates
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Review of Requirements
RoHS II Responsibilities
Manufacturer Importer
EU Declaration of Conformity EU Declaration of Conformity from manufacturer on record
Technical File Ensure manufacturer has completed the technical file
CE Marking Ensure CE Mark is affixed to the product
Product marking
Ensure manufacturer has completed required product marking
(brand name, serial number, contact information)
Note: Article 7(h) states: manufacturers (shall) indicate their name, registered trade name or registered
trade mark and the address at which they can be contacted on the EEE or, where that is not possible, on
its packaging or in a document accompanying the EEE.
Article 7(d) states: importers indicate their name, registered trade name or registered trade mark and the
address at which they can be contacted on the EEE or, where that is not possible, on its packaging or in
a document accompanying the EEE.
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Review of Requirements (continued)
RoHS II Responsibilities
Article 8a allows for an authorized representative to be appointed by written mandate by a manu-
facturer. Should an authorized representative be appointed they can deal with all manufacturer’s
obligations except for being responsible for the RoHS compliant design and manufacture and the
drawing up of the technical documentation.
Practical Application: Non-EU manufacturers can assign an authorized representative and that
address would be present OR the importer’s information must be on the product or on its pack-
aging or in an accompanying document. Having the manufacturer information as well as the im-
porter’s is not an issue but the point is to have a member state entity’s information with the EEE.
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Review of Requirements
Declaration of Conformity
General Requirements:
1. No… (unique identification of the EEE):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or
installer):
4. Object of the declaration (identification of EEE allowing traceability. It may include a photo-
graph, where appropriate):
5. The object of the declaration described above is in conformity with Directive 2011/65/EU of
the European Parliament and of the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic equipment (recast)
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6. Where applicable, references to the relevant harmonised standards used or references to the
technical specifications in relation to which conformity is declared:
7. Additional information:
Signature:
• Signed for and on behalf of:
• (place and date of issue):
• (name, function) (signature):
NOTE:
Declaration must be translated into the language or languages required by the Member
State of the market on which the product is placed or made available AND safety in-
structions must be in a language that can be easily understood in every country in the
EU in which the product is sold.
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Review of Requirements
Technical File
• Based on Module A of DECISION No 768/2008/EC
• Has to contain at least the following elements:
• a general description of the product,
• conceptual design and manufacturing drawings and schemes of components,
sub-assemblies, circuits, etc.
• descriptions and explanations necessary for the understanding of those drawings and
schemes and the operation of the product,
• a list of the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the European Union,
applied in full or in part, and descriptions of the solutions adopted to meet the essential
requirements of the legislative instrument where those harmonised
• standards have not been applied. In the event of partly applied harmonised standards,
the technical documentation shall specify the parts which have been applied,
• results of design calculations made, examinations carried out, etc., and
• test reports.
• The documentation shall make it possible to assess the product’s conformity to the relevant
requirements, and shall include an adequate analysis and assessment of the risk
• N 50581 – Standard for EU Technical Files – Published Sept 2012
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Review of Requirements
Technical File – EN 50581
Technical documentation for the assessment of electrical and electronic products with respect
to the restriction of hazardous substances
• Combination of:
• RoHS Recast (Directive 2011/65/EU)
• Module A of Decision 768/2008
• IEC 62476 – Guidance for evaluation of products with respect to substance-use restric-
tions in electrical and electronic products [Existed Previous to RoHS Recast]
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Review of Requirements
Technical File – EN 50581
Beyond EN 50581, it should not be expected that there will be significantly more detail from the
EU Commission. Official statement by the EU Commission regarding RoHS recast:
…as a general rule and in the interests of legal certainty, it is inappropriate for the Commission to
make interpretative statements on legislative texts, which should be comprehensible in themselves.
…note that it is in any event for the Court of Justice alone to provide authoritative interpretations
as to the meaning of Union law.
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Review of Requirements
Technical File – EN 50581
FOUR MAJOR TASKS:
• Determine the information needed
• Collect the information
• Evaluate the information for:
• quality and trustworthiness
• whether to include the documentation in the technical file
• Ensure that the technical documentation remains valid
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Review of Requirements
RoHS II – Exemptions
RoHS recast has two (2) groups of Exemptions:
• Annex III – Applications exempted from the restriction in Article 4(1)
• Annex IV – Applications exempted from the restriction in Article 4(1) specific to medical devices
and monitoring and control instruments
Validity Date
• Annex III:
• For the exemptions listed in Annex III as at 21 July 2011, the maximum validity period,
which may be renewed, shall, for categories 1 to 7 and 10 of Annex I, be 5 years from 21
July 2011 and, for categories 8 and 9 of Annex I, 7 years from the relevant dates laid down
in Article 4(3), unless a shorter period is specified.
• Annex IV:
• For the exemptions listed in Annex IV as at 21 July 2011, the maximum validity period,
which may be renewed, shall be 7 years from the relevant dates laid down in Article 4(3),
unless a shorter period is specified.
• Unless otherwise specified
• Thirty-eight (38) Annex III exemptions currently have a specified
sunset date
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If an exemption is not renewed, it would proceed to a revocation process
• Applications for renewal are required to be submitted at least eighteen (18) months before the
expiry date of an exemption
• Similar to the Authorisation Process under REACH
• If a decision is made to revoke an exemption, the exemption will expire twelve (12) to eighteen
(18) months from the date of the decision
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Mercury in single capped (compact) fluorescent
1
lamps not exceeding (per burner):
Expired on 31 December 2011;
3,5 mg may be used per burner after 31 December
1a For general lighting purposes < 30 W: 5 mg 2011 until 31 December 2012;
2,5 mg shall be used per burner after 31 December
2012
For general lighting purposes ≥ 30 W and < 50 Expired on 31 December 2011; 3,5 mg may be
1b
W: 5 mg used per burner after 31 December 2011
For general lighting purposes ≥ 50 W and < 150
1c
W: 5 mg
1d For general lighting purposes ≥ 150 W: 15 mg
For general lighting purposes with circular No limitation of use until 31 December 2011; 7
1e or square structural shape and tube diameter mg may be used per burner after 31 December
≤ 17 mm 2011
1f For special purposes: 5 mg
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Mercury in double-capped linear fluorescent
2a lamps for general lighting purposes not exceed-
ing (per lamp):
Tri-band phosphor with normal lifetime and a Expired on 31 December 2011; 4 mg may be
2a1
tube diameter < 9 mm (e.g. T2): 5 mg used per lamp after 31 December 2011
Tri-band phosphor with normal lifetime and a
Expired on 31 December 2011; 3 mg may be
2a2 tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5):
used per lamp after 31 December 2011
5 mg
Tri-band phosphor with normal lifetime and a
Expired on 31 December 2011; 3,5 mg may be
2a3 tube diameter > 17 mm and ≤ 28 mm (e.g. T8):
used per lamp after 31 December 2011
5 mg
Tri-band phosphor with normal lifetime and a Expired on 31 December 2012; 3,5 mg may be
2a4
tube diameter > 28 mm (e.g. T12): 5 mg used per lamp after 31 December 2012
Tri-band phosphor with long lifetime (≥ 25 000 Expired on 31 December 2011; 5 mg may be
2a5
h): 8 mg used per lamp after 31 December 2011
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Mercury in other fluorescent lamps not exceed-
2b
ing (per lamp):
Linear halophosphate lamps with tube > 28 mm
2b1 Expired on 13 April 2012
(e.g. T10 and T12): 10 mg
Non-linear halophosphate lamps (all diameters):
2b2 Expires on 13 April 2016
15 mg
No limitation of use until 31 December 2011;
Non-linear tri-band phosphor lamps with tube
2b3 15 mg may be used per lamp after 31 December
diameter > 17 mm (e.g. T9)
2011
No limitation of use until 31 December 2011;
Lamps for other general lighting and special
2b4 15 mg may be used per lamp after 31 December
purposes (e.g. induction lamps)
2011
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Mercury in cold cathode fluorescent lamps and
external electrode fluorescent lamps (CCFL and
3
EEFL) for special purposes not exceeding (per
lamp):
No limitation of use until 31 December 2011;
3a Short length (≤ 500 mm) 3,5 mg may be used per lamp after 31 December
2011
No limitation of use until 31 December 2011;
3b Medium length (> 500 mm and ≤ 1 500 mm) 5 mg may be used per lamp after 31 December
2011
No limitation of use until 31 December 2011;
3c Long length (> 1 500 mm) 13 mg may be used per lamp after 31 December
2011
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
No limitation of use until 31 December 2011;
Mercury in other low pressure discharge lamps
4a 15 mg may be used per lamp after 31 December
(per lamp)
2011
Mercury in High Pressure Sodium (vapour)
lamps for general lighting purposes not exceed-
4b
ing (per burner) in lamps with improved colour
rendering index Ra > 60:
No limitation of use until 31 December 2011; 30
4b-I P ≤ 155 W mg may be used per burner after 31 December
2011
No limitation of use until 31 December 2011; 40
4b-II 155 W < P ≤ 405 W mg may be used per burner after 31 December
2011
No limitation of use until 31 December 2011; 40
4b-III P > 405 W mg may be used per burner after 31 December
2011
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Mercury in other High Pressure Sodium (va-
4c pour) lamps for general lighting purposes not
exceeding (per burner):
No limitation of use until 31 December 2011; 25
4c-I P ≤ 155 W mg may be used per burner after 31 December
2011
No limitation of use until 31 December 2011; 30
4c-II 155 W < P ≤ 405 W mg may be used per burner after 31 December
2011
No limitation of use until 31 December 2011; 40
4c-III P > 405 W mg may be used per burner after 31 December
2011
Mercury in High Pressure Mercury (vapour)
4d Expires on 13 April 2015
lamps (HPMV)
4e Mercury in metal halide lamps (MH)
Mercury in other discharge lamps for spe-
4f cial purposes not specifically mentioned
in this Annex
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
5a Lead in glass of cathode ray tubes
Lead in glass of fluorescent tubes not exceeding
5b
0,2 % by weight
Lead as an alloying element in steel for machin-
6a ing purposes and in galvanised steel containing
up to 0,35 % lead by weight
Lead as an alloying element in aluminium con-
6b
taining up to 0,4 % lead by weight
Copper alloy containing up to 4 % lead by
6c
weight
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Lead in high melting temperature type sol-
7a ders (i.e. lead- based alloys containing 85 % by
weight or more lead)
Lead in solders for servers, storage and storage
array systems, network infrastructure equipment
7b
for switching, signalling, transmission, and net-
work management for telecommunications
Electrical and electronic components containing
lead in a glass or ceramic other than dielectric
7c-I
ceramic in capacitors, e.g. piezoelectronic de-
vices, or in a glass or ceramic matrix compound
Lead in dielectric ceramic in capacitors for a rat-
7c-II
ed voltage of 125 V AC or 250 V DC or higher
Expired on 1 January 2013 and after that date
Lead in dielectric ceramic in capacitors for a rat-
7c-III may be used in spare parts for EEE placed on the
ed voltage of less than 125 V AC or 250 V DC
market before 1 January 2013
Lead in PZT based dielectric ceramic materials
for capacitors which are part of integrated cir-
7c-IV Expires on 21 July 2016
cuits or discrete semiconductors (*Amendment
on 18/12/2012)
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Expired on 1 January 2012 and after that date
Cadmium and its compounds in one shot pellet
8a may be used in spare parts for EEE placed on the
type thermal cut-offs
market before 1 January 2012
Cadmium and its compounds in electrical
8b
contacts
Hexavalent chromium as an anticorrosion agent
of the carbon steel cooling system in absorption
9
refrigerators up to 0,75 % by weight in the cool-
ing solution
Lead in bearing shells and bushes for refrigerant-
containing compressors for heating, ventilation,
9b
air conditioning and refrigeration (HVACR)
applications
Lead used in C-press compliant pin connector May be used in spare parts for EEE placed on the
11a
systems market before 24 September 2010
Expired on 1 January 2013 and after that date
Lead used in other than C-press compliant pin
11b may be used in spare parts for EEE placed on the
connector systems
market before 1 January 2013
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Review of Requirements
RoHS II – Exemptions
No. exemption Scope and Dates of Applicability
Lead as a coating material for the thermal con- May be used in spare parts for EEE placed on the
12
duction module C-ring market before 24 September 2010
13a Lead in white glasses used for optical applications
Cadmium and lead in filter glasses and glasses
13b
used for reflectance standards
Lead in solders consisting of more than two ele-
ments for the connection between the pins and Expired on 1 January 2011 and after that date
14 the package of microprocessors with a lead con- may be used in spare parts for EEE placed on the
tent of more than 80 % and less than 85 % by market before 1 January 2011
weight
Lead in solders to complete a viable electrical
15 connection between semiconductor die and car-
rier within integrated circuit flip chip packages
Lead in linear incandescent lamps with silicate
16 Expires on 1 September 2013
coated tubes
Lead halide as radiant agent in high intensity
17 discharge (HID) lamps used for professional re-
prography applications
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Review of Requirements
RoHS II – Exemptions
Scope and Dates of Applicabil-
No. exemption
ity
Lead as activator in the fluorescent powder (1 % lead by
weight or less) of discharge lamps when used as speciality
18a lamps for diazoprinting reprography, lithography, insect Expired on 1 January 2011
traps, photochemical and curing processes containing
phosphors such as SMS ((Sr,Ba) 2 MgSi 2 O 7 :Pb)
Lead as activator in the fluorescent powder (1 % lead by
weight or less) of discharge lamps when used as sun tan-
18b
ning lamps containing phosphors such as BSP (BaSi 2 O
5 :Pb)
Lead with PbBiSn-Hg and PbInSn-Hg in specific compo-
19 sitions as main amalgam and with PbSn-Hg as auxiliary Expired on 1 June 2011
amalgam in very compact energy saving lamps (ESL)
Lead oxide in glass used for bonding front and rear sub-
20 strates of flat fluorescent lamps used for Liquid Crystal Expired on 1 June 2011
Displays (LCDs)
Lead and cadmium in printing inks for the application
21 of enamels on glasses, such as borosilicate and soda lime
glasses
Lead in finishes of fine pitch components other than con- May be used in spare parts for EEE placed on
23
nectors with a pitch of 0,65 mm and less the market before 24 September 2010
Lead in solders for the soldering to machined through hole
24
discoidal and planar array ceramic multilayer capacitors
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Review of Requirements
RoHS II – Exemptions
Scope and Dates of Applicabil-
No. exemption
ity
Lead oxide in surface conduction electron emitter
25 displays (SED) used in structural elements, notably
in the seal frit and frit ring
Lead oxide in the glass envelope of black light blue
26 Expired on 1 June 2011
lamps
Lead alloys as solder for transducers used in high-
powered (designated to operate for several hours
27 Expired on 24 September 2010
at acoustic power levels of 125 dB SPL and above)
loudspeakers
Lead bound in crystal glass as defined in Annex I
29 (Categories 1, 2, 3 and 4) of Council Directive
69/493/EEC ( 1 )
Cadmium alloys as electrical/mechanical solder
joints to electrical conductors located directly on the
30 voice coil in transducers used in high-powered loud-
speakers with sound pressure levels of 100 dB (A)
and more
Lead in soldering materials in mercury free flat fluo-
31 rescent lamps (which, e.g. are used for liquid crystal
displays, design or industrial lighting)
Lead oxide in seal frit used for making window as-
32
semblies for Argon and Krypton laser tubes
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Review of Requirements
RoHS II – Exemptions
Scope and Dates of Applicabil-
No. exemption
ity
Lead in solders for the soldering of thin copper wires
33
of 100 μm diameter and less in power transformers
Lead in cermet-based trimmer potentiometer
34
elements
Mercury used as a cathode sputtering inhibitor in
36 DC plasma displays with a content up to 30 mg per Expired on 1 July 2010
display
Lead in the plating layer of high voltage diodes on
37
the basis of a zinc borate glass body
Cadmium and cadmium oxide in thick film pastes
38
used on aluminium bonded beryllium oxide
Cadmium in colour converting II-VI LEDs (< 10 μg
39 Cd per mm 2 of light-emitting area) for use in solid Expires on 1 July 2014
state illumination or display systems
Cadmium in photoresistors for analogue opto-
40 couplers applied in professional audio equipment Expires on 31 Dec 2013
(*Amendment on 10/10/2012)
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Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
Determination of Necessary Information
• Assess what types of documents are required based on substance presence risk and supplier risk
• Technical judgement allowed
Collection of Information
• Types of allowed documentation
»» Supplier declarations
»» Material Declarations
»» Analytical test results
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Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
Evaluation of Data
• Mandatory for Manufacturers
• Requirements include:
• Establish procedures for evaluating collected information / documentation
• Evaluate whether each part, component, or material meets the materials restriction re-
quirements of RoHS Recast
• Evaluate whether the document is of sufficient quality to include in the technical
documentation
»» Criteria met = Included
»» Criteria not met = further corrective actions or analysis
Ensuring Validity of Data
• Requirements:
• periodic review of the documents contained in the technical documentation to ensure that
they are still valid;
• technical documentation must reflect any changes to materials, parts or sub-assemblies
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
40. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
STANDARD PRACTICE:
• Annual Updates – with the Annual Audit!
• Significant Product Changes = Update File
• Completeness in the Technical File:
• Consumables
• Out of Scope Parts
• Not part of the RoHS Compliance THEREFORE not required to be included
»» Recommended that the out of scope and consumable parts are footnoted
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
41. AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044
Due Diligence and Testing – EN 62321
What is their role in RoHS II Compliance –
specifically the Technical File?
Electrotechnical products – Determination of levels of six regulated substances (lead, mercury,
cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers)
• EU Standard for RoHS testing
• Not Mandatory…HOWEVER:
»» Most effective method of risk management
»» Usually less costly than alternative (further/increased) supplier data gathering
and/or corrective action methods
»» Testing to an established standard allows you to quote it in the file = lends credibility
• If you have done it right, others don’t have to!
• Recommended to have at least scan testing to EN 62321:2009 in technical file
»» XRF
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]