Regulatory Update

United Arab Emirates (UAE) RoHS

Last month I presented a webinar for Compliance & Risks on the new RoHS-like regulation in the United Arab Emirates, promulgated at the end of April. While the regulation is essentially based on the EU RoHS Directive, it has issues: it contains typos, definition errors (such as swapping voltage ranges that define EEE between AC and DC – i.e., UAE RoHS specifies 1500VAC and 1000VDC, while EU RoHS specifies 1000VAC and 1500VDC), a long-standing problem with properly defining exemptions which – if taken literally – could be interpreted to say that nearly every instance of EEE is excluded from the scope because it takes an exemption, and reference to a conformity assessment system, ECAS (Emirates Conformity Assessment System), which remains undefined for this product category.

While the ECAS system has in fact been in place for a while, complex products like EEE have not been subject to it.

The regulation is phased in over time, but the first tranche comes into force on January 1, 2018. Products in EU RoHS-equivalent categories 1-7 and 10 must have been approved through ECAS by then in order to be sold after that date (except for items that were already available on the market). This has manufacturers very concerned – the ECAS system could well be a bottleneck preventing product from being available at the start of next year! But we don’t know because the entity in charge, the Emirates Authority for Standardization and Metrology (ESMA), has been nonresponsive to inquiries we have placed in both English and Arabic.

So stay tuned.

The Swedish consultation on MCCP

The Swedish Chemicals Agency, KEMI, is collecting information in its quest to restrict the use of medium chained chlorinated paraffins (MCCP) in EEE under the RoHS Directive. 

MCCPs can be found in some PVC cable jacketing and insulation materials.

China RoHS: Will They Ever Get to Phase 2?

At the end of June the China Ministry of Industry and Information Technology (MIIT) issued a notice for public comment on a draft "catalog" of Electrical and Electronic Products (EEPs). Presumably, the products listed must meet the substance restriction requirements of GB/T 26572-2011, Requirements of Concentration Limits for Certain Restricted Substances in Electrical and Electronic Products (an English translation of which is for sale through our China RoHS website). A draft list of acceptable exemptions is also included. The comment period closed on July 28.

The proposed list of products to be subject to these substance restrictions (which, fortunately, are more or less aligned with EU RoHS) are:

1. Refrigerators
2. Air Conditioners
3. Washing Machines
4. Water Heaters
5. Printers
6. Copiers
7. Fax Machines
8. TV Sets
9. Monitors
10. Microcomputers
11. Cell phones
12. Telephones

While complying with the technical restrictions should not present a problem for the majority of these products (since most, if not all, are manufactured taking EU RoHS into account), the administrative details of the compliance requirements remain obscure. Article 18 of the China RoHS regulation requires the government to define a "conformity assessment system" that these products would be subject to. Since this has not yet been defined – or agreed to by EEP manufacturers – we believe the provision of this list is premature. Remember what happened the last time MIIT (MII at the time) tried this, in 2009? They defined the conformity assessment requirements to include chemical testing down to the homogeneous material level of each and every component and material used in each and every product that would have to comply with the requirement. All testing has to be done through Chinese government labs, of which 18 were defined. This presented such a high bar for cost and delays that industry revolted: should the requirement stand, the Chinese population would simply not be able to purchase the target products (which included printers and cell phones, among others). MII relented and withdrew the proposal, and China RoHS has remained a declaration-only regulation.

Given the apparent lack of institutional memory at MIIT demonstrated by the poorly thought-out China RoHS 2 regulation, an incredibly short timeline from promulgation to in-force, and the resulting need to clarify so many regulatory points through a FAQ that itself was issued just weeks before the regulation came into force (not unlike the FAQs under China RoHS 1, the final versions of which were issued a week prior to the in-force date; that had manufacturers scrambling!), perhaps we should not be surprised by the cart being put before the horse again. If MIIT wants to have a chance of success with this regulatory development they must work with industry to define and agree upon the conformity assessment system (hint: align it with EU RoHS requirements and reference IEC 63000:2016, instead of EN 50581:2012, to enable a risk-based approach to compliance) before finalizing the product categories that will be subject to the restriction regimen.

EU REACH: Final Version 4.0 of Guidance on requirements for substances in Articles

Also at the end of June the European Chemicals Agency (ECHA) finally issued the revised articles guidance that includes examples based on the September 2015 judgement by the European Court of Justice on how to interpret the term “article”.

The guidance focuses on Article 7, regarding notification of ECHA of uses of candidate list SVHCs in volumes exceeding one metric ton per year, as well as Article 33, on notification of customers and consumers of the presence of candidate list SVHCs in articles.

While much of the guidance is effectively the same as it was in version 2, particularly as it relates to determining what is an article, new terminology has been introduced to define “complex objects”, which consist of many articles.

The guidance is generally clear enough, but could perhaps have gone further to explain how to consider the addition of adhesives and solders (that may contain candidate list SVHCs) to complex objects when attaching more articles or complex objects to them (as in the case of components being attached to bare printed circuit boards, PCBs). Example 21 is all about PCBs, but is focused on evaluating what is an article on it. This is useful and important, but is not the complete story. The opportunity to discuss the adhesives and solders, the potential presence of SVHCs in them and how to measure them against the articles and complex objects they attach is missed.

As ECHA had stated (and as I mentioned earlier this year), perhaps industry itself will have to step up to the plate and write our own extension to the guidance. We’ll have to see if that becomes necessary.

Contact

Visit DCA at www.DesignChainAssociates.com or email me with any questions or comments on this post.