1. Update on Product Related Environmental Regulations
Presented to the
Joint Meeting of the Boston and Chicago Chapters
IEEE Product Safety Engineering Society
and the
Northeast Product Safety Society by
Steve Brody
Product EHS Consulting LLC
September

2. EU Proposed Market Surveillance Regulation
Topics for Discussion
EU RoHS 2
EU WEEE 2
China RoHS
EU Proposed Market Surveillance Regulation
Product EHS Consulting LLC
September 25, 2013

3. EU RoHS 2
Directive 2011/65/EU is a recast of RoHS 1 (2002/95/EC) and repeals the latter
Entered into force on July
Member States must transpose into law by January
Scope has changed and some previously exempt products are now in scope
RoHS 2 is a CE Marking Directive
Product EHS Consulting LLC
September 25, 2013

4. EU RoHS 2 - Substances Substances and concentrations remain the same
0.1% by weight in Homogenous Materials for:
Lead, Mercury, Hexavalent Chromium, Polybrominated Biphenyls (PBBs), and Polybrominated Diphenyl Ethers (PBDEs)
0.01% by weight in Homogenous Materials for:
Cadmium
CAUTION:
This list will be reviewed by the Commission by July
Member States can propose new substance restrictions.
Product EHS Consulting LLC
September 25, 2013

5. EU RoHS 2 - Scope The original 10 Categories are still intact:
Category 1 – Large Household Appliances
Category 2 – Small Household Appliances
Category 3 – IT and Telecommunications Equipment
Category 4 – Consumer Equipment
Category 5 – Lighting Equipment
Category 6 – Electrical and Electronic Tools (not including LSIT)
Category 7 – Toys, Leisure and Sports Equipment
Category 8 – Medical Devices (now in scope!)
Category 9 – Monitoring and Control Instruments (now in scope!)
Category 10 – Automatic Dispensers
And an 11th Category has been added:
Other EEE not covered by any of the categories above !
Product EHS Consulting LLC
September 25, 2013

6. EU RoHS 2 – Effective Dates
January 2, 2013:
Categories 1 – 7
Large-scale Stationary Industrial Tools remain our of scope
July :
Medical Devices
Non-Industrial Monitoring and Control Instruments
July
In-Vitro Medical Devices
July
Industrial (Professional) Monitoring and Control Instruments
July
Other EEE (all those not previously covered and not exempt or out of scope) – the new Category 11
Product EHS Consulting LLC
September 25, 2013

7. EU RoHS 2 – Scope (con’t)
Spare parts and cables for the repair, the reuse, the updating of functionalities, or upgrading of capacity for a specific product category, are in scope from the same date as the product category they are intended to be used in but do nto require their own CE Mark or DoC
A cable is defined as being external to the equipment; anything within a product is internal wiring and must comply or not per the product it is used in
Cable placed on the market as a standalone item is within scope and must comply and have a CE Mark and a DoC
If a product is out of scope and the cable or spare part is designed specifically for and is intended to be used only in that equipment that is out of scope, then the cable or spare part is also out of scope
Product EHS Consulting LLC
September 25, 2013

8. EU RoHS 2 – Scope (con’t)
If a cable was out of scope according to RoHS 1, then it remains out of scope of RoHS 2 until 22 July 2019
Components that are sold only as a replacement or spare part of one in an existing product, need to comply buy the same date as the product they are used in, but do not need a CE Mark or DoC
If a product such as a graphics board is placed on the market as a stand-alone, it is not considered a ‘component’ but is instead a finished product and must comply and be marked.
Product EHS Consulting LLC
September 25, 2013

9. EU RoHS 2 – Out of Scope Batteries Packaging
Products intended solely for R&D (this does not include standard laboratory products used in conjunction with R&D)
Equipment essential for the protection of the essential interests of member states (arms, war, and military products)
Equipment to be sent into space
Large-scale industrial tools
Large-scale fixed installations
Products designed and solely intended for any of the above
Product EHS Consulting LLC
September 25, 2013

10. EU RoHS 2 - Definitions
A key change in the definition of ‘dependent on electrical current’ moves from the PRIMARY function of the device to ‘AT LEAST ONE INTENDED’ function of the device.
Example 1: Sneakers with lights were out of scope of RoHS 1 as the lights were not the ‘primary function’, but the sneakers are now in scope as the lights are now ‘at least one intended function’
Example 2: Optical cables are not EEE and are not within scope
Product EHS Consulting LLC
September 25, 2013

11. EU RoHS 2 – CE Mark and DoC
When a product is in scope of the Directive a CE Mark and DoC is required as of the Effective Date
Only one CE Mark is required on the product no matter how many Directives apply to the product
The CE Mark is the only Mark that can indicate compliance to the RoHS 2 Directive
Some believe that no other marks can be used, such as a green check mark or similar, but If a product is sold in markets other than the EU a green check mark or something similar would tell the customer that the product is free of or within the limits for one or more of the six substances
Product EHS Consulting LLC
September 25, 2013

12. EU RoHS 2 – CE Mark
The determination of which marks may or may not be used will probably be a judgment call and will most likely end up in the EU Courts for a clearer definition
The safe approach is to review any marks you use and make sure they don’t say things like ‘RoHS Compliant’, ‘Lead Free’, ‘Meets EU RoHS’, etc. and that they are not in the immediate vicinity of the CE Mark
Product EHS Consulting LLC
September 25, 2013

13. EU RoHS 2 –DoC and TCF
The RoHS 2 Directive is to be added to the existing DoC or DoI to indicate the product is compliant just as you would for the LVD or EMC Directive or Machinery Directive.
Harmonized standards that were used in the determination that the product is RoHS compliant must be included on the DoC under the reference to the Directive
And as with any other CE Marking Directive you must have a Technical Construction File to support your claims
Product EHS Consulting LLC
September 25, 2013

14. EU RoHS 2 –DoC and TCF
The only standard harmonized with the RoHS 2 Directive:
EN – Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
Other standards which may be helpful are:
EN Electrotechnical products – Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers.
EN Material Declaration for products of and for the electrotechnical industry
Product EHS Consulting LLC
September 25, 2013

15. EU RoHS 2 – TCF
EN is the key one as it describes what must be in the Technical Construction File (TCF) for RoHS compliance
General description of the product
What is it, what does it do, model/part numbers, etc.
Documentation for materials, parts, and/or sub-assemblies
Assembly drawings, schematics, fabrication drawings, etc. with your part numbers
Information showing the relationship between the documents and the corresponding materials, parts, and/or sub-assemblies on the product
Bill of Materials relating your part numbers to your suppliers parts
List of Harmonized Standards and/or other technical publications that have been used to establish compliance
Product EHS Consulting LLC
September 25, 2013

16. EU RoHS 2 – TCF
The standard, under ‘Tasks to be undertaken by the manufacturer’ it says:
Determine the information needed
You determine the probability that the restricted substance is present; would be a good idea to write an engineering judgment as to why you believe it is not present.
Collect the information
Supplier declarations, IPC-1725 forms, etc. signed and date Purchase Orders specifying the substances and limits, test data, etc.
Evaluate the information with regard to its quality and trustworthiness and decide whether to include it in the technical documentation
You determine the trustworthiness of the supplier and the data they provide to you
Ensure that the technical documentation remains valid
Some type of auditing process to ensure you know about changes to the substances in the product
Product EHS Consulting LLC
September 25, 2013

17. EU RoHS 2 –DoC and TCF Non-Harmonized standards:
EN Electrotechnical products – Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers
Describes the analytical test methods used to determine if and how much of the substance is present
EN Material Declaration for products of and for the electrotechnical industry
Provides information on what a material declaration form would look like, similar to an IPC-1725 form
Product EHS Consulting LLC
September 25, 2013

18. EU RoHS 2 – Additional Information
The EU issued an FAQ after receiving input from industry in response to a June 2012 draft. The current FAQ, dated 12 December 2012 is the result of the inputs and the EU review. It can be found at
This presentation is not intended to provide a comprehensive package for you to make your decisions on. You MUST read the Directive and determine how it best applies to your specific products and situations
Product EHS Consulting LLC
September 25, 2013

19. Ready for more?
And if the RoHS recast with expanded scope was not enough to ruin your day, along comes WEEE 2
Product EHS Consulting LLC
September 25, 2013

20. EU WEEE 2 – The Basics Directive 2012/19/EU replaces 2002/96/EC
Effective as of August 13, 2012, however there is a transitional period until August 14, 2018, and the Directive is fully implemented as of August 15, 2018
Same basic products that are out of scope of RoHS 2 are out of scope for WEEE 2 as well as most of those from WEEE 1
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;
Product EHS Consulting LLC
September 25, 2013

21. EU WEEE 2 – Out of Scope
Equipment which is specifically designed and installed as part of another type of equipment that is excluded from or does not fall within the scope of this Directive, which can fulfil its function only if it is part of that equipment
Filament bulbs
Equipment designed to be sent into space
Large-scale stationary industrial tools (LSIT)
Large-scale fixed installations (LSFI), except any equipment which is not specifically designed and installed as part of those installations
Product EHS Consulting LLC
September 25, 2013

22. EU WEEE 2 – Out of Scope
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;
Equipment specifically designed solely for the purposes of research and development that is only made available on a business-to-business basis;
Medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices
Product EHS Consulting LLC
September 25, 2013

23. EU WEEE 2 – The Basics
Components put on the market separately in order to be used for repair and/or construction of an EEE and not as part of a complete assembly kit, fall outside the scope of the Directive
Components and sub-assemblies intended solely for use in products that are not within the scope of WEEE2, are also not within scope
If a product can be used for both products that are out of scope and products that are in scope, then it is a dual use product and as such is in scope no matter where it is used.
Ways to prove that a product, component, or sub-assembly is solely intended for out of scope use can be sales and marketing literature, sales history, etc.
Product EHS Consulting LLC
September 25, 2013

24. EU WEEE 2 – The Basics
There is a requirement that if the product is sold in a given Member State, then there needs to be an Authorized Representative in that Member State
This means that you may need to have an AR in each Member State
Depends on who and how the product is being sold including distance selling
‘Producer’ can be the Manufacturer, Importer, Distributor, or Reseller – aka Economic Operators
Branding plays a role for who is responsible
Product EHS Consulting LLC
September 25, 2013

25. EU WEEE 2 – The Basics
If a product (EEE) is used and is being shipped within the EU or outside the EU it will be considered WEEE unless there is some evidence and certification (can be self) that the product is still functional or is being returned for upgrade
Invoices and shipping documents for each item in the shipment must also state that it is functional EEE or being returned for an upgrade
Defective (failed) EEE may be shipped from business to business for failure analysis but there must be proof of this action and the shipping documents must state this
Product EHS Consulting LLC
September 25, 2013

26. EU WEEE 2 – The Basics
The ‘wheelie bin’ label is retained but there is no solid line under it as was for WEEE 1
The Directive is still being reviewed, understood, and digested
An FAQ is being developed by the EU
Again, you need to read the Directive for yourself and make the determination of how it affects your product, your sales process for understanding Authorized Representatives
WEEE 2 is not a CE Marking Directive
Product EHS Consulting LLC
September 25, 2013

27. EU REACH
Product EHS Consulting LLC
September 25, 2013

28. EU REACH The basics of REACH have not changed
REACH deals with ‘substances’ (chemicals) and ‘articles’ (products)
The most important thing to note for REACH is that the list of SVHCs (Substances of very High Concern) has and continues to increase.
As of April 2013 there are 144 SVHCs on the Candidate List (to be evaluated) and 22 on the Authorization List (prohibited to use or place on the market)
That is projected to be in the hundreds in a few years
Product EHS Consulting LLC
September 25, 2013

29. EU REACH
If you have SVHCs in your product you have a responsibility to notify users if:
the substance has been included on the candidate list and
the substance is present in the articles (product) above a concentration of 0.1% weight by weight (w/w) and
the total amount of the substance in the articles exceeds one ton per producer or importer per year and
the substance has not yet been registered for that specific use.
An EU SDS is required for all Registered Substances
An OSHA style MSDS is not suitable
Product EHS Consulting LLC
September 25, 2013

30. China RoHS
Product EHS Consulting LLC
September 25, 2013

31. Moving to China RoHS
Draft of new China RoHS was out for comment on June and the end date for comments was July 10, 2012
The new Catalog will be called ‘Target Administrative Catalogue for the Pollution Control of Electrical and Electronic Products’
The 2006 China RoHS will be phased out when the new set of rules is made official
Substance list remains the same but may now be restricted, rather than just reported
Product EHS Consulting LLC
September 25, 2013

32. China RoHS
Scope of products is likely to be increased, but primary focus should remain household and consumer items
China may allow for self-certification and use of a 3rd party lab – not necessarily a Chinese lab
Watch for future developments and no timeline for implementation has been published.
Product EHS Consulting LLC
September 25, 2013

33. Korea RoHS and Taiwan RoHS
And not far behind are…
Korea RoHS and Taiwan RoHS
Product EHS Consulting LLC
September 25, 2013

34. EU Proposed Market Surveillance Regulation
And just as an FYI
EU Proposed Market Surveillance Regulation
(MSR)
Product EHS Consulting LLC
September 25, 2013

35. And just when you thought you knew it all…
Here comes the EU’s Proposed Market Surveillance Regulation (MSR) – COM (2013) 75, dated Feb
This proposal will create MSR authorities in each member state with wide ranging authority to stop products from entering the EU if they have any reason to believe they present a risk to health and/or safety
They will have the authority to perform a complete risk assessment, if, in their opinion, the product presents a risk even if it has a DoC or DoI and a TCF supported by 3rd party test reports
Product EHS Consulting LLC
September 25, 2013

36. More on the Proposed MSR
It will set up a new set of test labs in each member state to do the risk assessments – these labs may not be used for any other purpose so they will not be the existing test labs and certification bodies
As written all costs associated with a risk assessment, whether or not they find any problem, will be borne by the appropriate economic operator (manufacturer, importer, etc.)
Risk Assessment can be due to formal non-compliance (incorrect CE Mark, DoC, DoI, TCF, Documentation, etc.) or actual risk
Product EHS Consulting LLC
September 25, 2013

37. More on the Proposed MSR
Timeline:
Original proposal issued February 2013
Comments were due in June 2013
First set of proposed Amendments were released in July 2013
Second round of comments were due in early September 2013
Second set of proposed amendments were released this week
Debate and probably another round of comments and amendments will happen between now and sometime in 2014 before actual implementation of the new MSR
If you would like copies of the original and/or proposed amendments me and I will send them to you
Product EHS Consulting LLC
September 25, 2013

38. More on the Proposed MSR
It is my personal belief that this proposal as originally drafted and with some of the proposed amendments can be very detrimental to the current EU system of manufacturer self-declaration to EU Directives.
If you or your company belongs to an industry association I recommend you or your company representative talk to that association and ask if they are doing anything to comment on the proposal.
A new comment period will probably be announced when they have finished with this round of amendments
Product EHS Consulting LLC
September 25, 2013

39. And of course Steve Brody Product EHS Consulting LLC
Thanks for your time and attention
Steve Brody
Product EHS Consulting LLC
Your Out-Source for Global Product Regulatory and Compliance Solutions or
Product EHS Consulting LLC
September 25, 2013