Report: Millennials in the Supply Chain
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Despite months of trying to get clarifying information on the new United Arab Emirates (UAE) RoHS regulation and failing, I held a webinar - UAE RoHS Legislation: Regulatory Update - with Compliance & Risks in July to discuss the key issues with the new regulation. Thanks to Peter Merguerian of Go Global Compliance, I finally was able to track down someone at the Emirates Authority for Standardization and Metrology (ESMA) in the UAE to get some answers to the questions everyone seems to have about UAE RoHS. Here are the latest updates.
One of the big questions has been “what is Form A and where can I find it?”
Turns out that “Form A” is more like “Module A” of EU Decision No. 768/2008/EC. It is not a “form” at all; it is a list of requirements contained in the Gulf Cooperation Council (GCC) Standardization Organization (GSO) “Guide of Conformity Assessment Forms” on page 7. Including a reference to this guide in the regulation would have been helpful.
Manufacturers effectively self-declare compliance and submit technical documents that demonstrate conformity to UAE RoHS across product design, manufacturing and operations processes.
The responsibility lies with the manufacturer, as long as they have a legal presence in the UAE, or with the manufacturer’s “authorized representative” (AR) in the UAE. The manufacturer, and the AR if there is one, keep the technical documentation for 10 years, along with a copy of the “conformity acknowledgement” received back from the Authority.
The Guide says that “Form A is known as the Supplier Declaration of Conformity (SDoC).”
The ECAS system is the certification scheme and ESMA is the implementing Authority. Form A documentation must be submitted through ECAS to ESMA for approval. To do so manufacturers or their ARs must register on the ECAS portal.
That was how it originally was defined. However, on October 1 ESMA issued “Implementing Guidelines” that appear to replace Form A documentation with two options:
Option 1:
- Risk assessment to be submitted in case the full product assessment for RoHS is not completed(!).
- Applicant submits a full RoHS test report of the complete product (if available). Otherwise three reports of the critical component to be submitted.
- How one determines what is “critical” is unclear.
- ESMA will verify compliance and issue the certificate
- Only valid for 1 year; annual renewal (and, probably, retest) is required
Option 2 (Module H, also listed in the above-mentioned “Guide of Conformity Assessment Forms”):
- Similar to the EU risk-based approach, the applicant submits risk assessment documents based on IEC 63000 (the approved international standard equivalent to EN 50581:2012, the EU’s RoHS risk assessment harmonized standard for RoHS) and IEC 62476:2010, “Guidance for evaluation of product with respect to substance-use restrictions in electrical and electronic products.” This is a standard, I believe, few are familiar with or use.
- ESMA – or their agents – verifies compliance to requirements and issues the certificate
- Must place Emirates Quality Mark (EQM) on product (yes, another mark!)
- Valid for three years
Note that the Implementing Guidelines also define the format for the “Declaration of Compliance” to be used for both options listed above. It is no longer the “SDoC” defined by Form A, apparently.
Concerns already abound about these requirements, considering that the law comes into force in less than three months. Not least among them, “how can we pull all this together on thousands of products in such a short time period?” and “how will they handle the huge volume of technical files in such a short period of time?”
ESMA’s response is that manufacturers should already have their technical files in place for EU RoHS compliance purposes, so they should be able to readily pull them together and send them in for review. I agree with that, but this is not what I have seen in practice at many manufacturers. This is the proverbial “shot across the bow” to get your technical files together now, and manage and maintain them properly!
Regarding their ability to handle the expected volume, ESMA will use “Notified Bodies” around the world to do the certification work. Companies like SGS, Intertek, TUV, UL, etc., which provide certification services for electromagnetic and safety compliance, will review your technical files and certify compliance with IEC 63000 and UAE RoHS requirements.
Among other issues, the most serious problem this raises is the fact that IEC 63000 (or EN 50581) has no defined and agreed-upon certification process. Will each of these companies be left on their own to decide how to interpret the requirements? ESMA will provide further information on this soon.
Another challenge is that the ECAS portal and its documentation (available by scrolling to the bottom of the ECAS web page) must be updated to cover this regulation, presuming compliance information must be provided through it. Currently, it is unclear about how the data will be provided to ESMA but perhaps it could be handled through the notified bodies. More information is forthcoming.
However, ESMA did clarify a number of errors, omissions and typos in the regulation for me, but they are not clarified in the Implementing Guidelines. Here are the corrections:
1) The regulations define products with a voltage rating not exceeding 1KV DC and 1.5KV AC. (EU RoHS states the opposite.)
- This is incorrect; it should state: electrical and electronic equipment designed for use with a voltage rating not exceeding 1000VAC (1kVAC) and 1500VDC (1.5kVDC).
2) Annex 4 contains numbered exemptions that could be interpreted as nonsensical, such as “30. Lead in:” and “34. Lead in:”
- These are typos. The intent is to follow the current consolidated version of Annex IV of the EU RoHS Directive (2011/65/EU).
3) The wording in Article 2, which covers scope, mixes up scope exclusion and substance exemption to the point where one could potentially read it as saying that every EEE that uses an exemption as listed in Annex 3 or 4 would itself be excluded from the scope of the law. Clearly, since nearly every EEE of just about any complexity uses an exemption, this would render the law impotent. The scope statement wording should be:
- This regulation shall apply to all electrical and electronic equipment (EEE) falling within the categories set out in Annex I of this regulation.
- This regulation does not apply to the products indicated in Annex 5 (please refer to point 4 above)
- Exemptions based on applications are listed in Annex 3 and Annex 4.
4) Regarding Annex 5, it is entitled “Definition of Technical Terms”, but none of the terms are actually referenced in the body of the regulation. ESMA said there intended to be a statement in Annex 5 (above the table) that noted these types of products as defined in the table are not covered by the regulation.
Additionally the table is intended to include:
- Military and defense material/equipment
- Equipment designed to be sent into space
Furthermore, following the EU’s approach, spare parts used to repair pre-regulation (i.e., non-compliant) product do not have to be compliant themselves.
One caution is that, when asked about language requirements, they said Arabic or English. While much information from the supply chain tends to be in English this is not always the case. Often we see information (particularly test reports) in Chinese. While I have yet to see anyone frog-marched into a jail cell in Brussels for providing a technical file to the EU enforcement authorities not entirely in the language of the Member State doing the asking, be aware of this.
Many questions remain, but ESMA appears to be now working to clarify the requirements of this regulation as its in-force date rapidly approaches.
Compliance & Risks has an English translation of the regulation available for sale. Contact them here.
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Copyright ©2017 Design Chain Associates, LLC, All Rights Reserved
Reprinted with permission from Design Chain Associates.
Click here for an update to the China RoHS 2 regulation.
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Thank you Michael for this deep and information feedback. Due diligence is indeed hard to define within a regulation moreover linked to global substance control. We face again the issue of the EU Self-Assessment Vs the rest of the world. Nevertheless, this issue is not isolated as we’ll encounter soon the same issue with Order 32 in China or J-Moss in Japan.
Moreover, the EN 50581 should be well known by manufacturers as it draws a clear framework on product compliance.
We’re longing to here you with more updated news, thanks !