REACH Update

Speaking of dynamic regulations, the European Union’s REACH regulation of course takes the cake for the environmental regulation that has the most moving parts manufacturers need to pay close attention to. The last time I took an in-depth look at REACH was in a two part series a couple years ago. Here are some recent items to be aware of:

SVHCs

The total number of SVHCs on the candidate list for authorization is now 163. Two were added on June 15. The two are:

  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5). ECHA says “These substances are used for example as plasticisers and lubricants, including use in adhesives, coatings, building material, cable compounding, polymer foils, PVC compounds and artist supply (e.g. modelling clay and finger paints).”
  • 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]. ECHA says this is an ingredient in fragrances, known as “karanal”. So review the ingredients for your scented capacitors! J

Authorization

ECHA has proposed fifteen additional substances for Authorization, including seven plasticizers and a common degreaser. If your company – or key suppliers – manufactures using these substances within the European Union or European Economic Area (EEA), you should review the proposal and your use of these substances. Consider whether to comment on the proposal and/or to work on identifying alternative substances or processes that will eliminate your use of these substances.

SVHC Roadmap to 2020

The implementation of the SVHC Roadmap to 2020 may be followed by visiting ECHA’s Public Activities Coordination Tool (PACT). This tool, which “gives advance notice of the substances that are on an authority's radar for exploring the potential need for regulatory risk management,” lists 287 substances of potential concern, along with a status for each of them. The analysis could potentially lead to one of the other REACH stages, including being listed as an SVHC or restriction, requiring additional information or a change to the substances classification, other regulatory management, or no action.

While most substances have not been through enough analysis to determine a next step, there are currently 14 that list “SVHC” as a follow-up. For these the outcome has been determined to be “Appropriate to initiate regulatory risk management action.” And, in fact, that is what is happening. Some of these substances, like 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate, have already been added to the SVHC list. Others, for example, Perfluorononan-1-oic acid (2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluorononanoic acid (PFNA) and its sodium and ammonium salts were determined to meet the criteria for SVHCs, as listed in REACH Article 57. For PFNA, the analysis indicates that there is a possibility for it to be used to replace PFOA and the desire to head off a possible “regrettable substitution” has resulted in its addition to the current SVHC Registry of Intentions (as of early August; the Registry of Intentions lists substances Member States intend to provide dossiers in order to propose their addition to the candidate list of SVHCs).

If you want to stay ahead of the SVHC list, prioritize reviewing this list of substances and assessing your products – and, if you have production facilities in the EU or EEA, your production processes – against it.

Shortlisted Substances

ECHA has also identified 200 registered substances “for further scrutiny”. They, and the Member State Competent Authorities, will examine “…the dossiers to decide whether there is a need for regulatory action, such as compliance check, substance evaluation, harmonised classification and labelling, authorisation or restriction.”

SVHC Registry of Intentions

There are seven substances listed in the Registry of Intentions that may show up in the next set of proposed SVHCs (expected in early September), as well as four more that could be added to the Winter 2016 tranche. One of these is yet another phthalate, Dicyclohexyl phthalate, with CAS number 84-61-7. Two, 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327) and 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350), are UV stabilizers that could potentially appear in a wide variety of polymers while PFNA, mentioned above, is a perflourinated substance used as “components of and precursors for surfactants and surface protectors in industrial applications and consumer products, such as impregnating agents for clothing and textiles, as coatings for paper and packaging, in waxes and cleaning agents, insecticides, fire-fighting foams and hydraulic fluids in airplanes.” The remaining two are primarily chemical intermediates that will probably not appear in finished goods (though nitrobenzene may be a component of lubricants).

The four substances targeted for the February 2016 tranche include two UV blockers found in cosmetics as well as two common Bisphenol-A replacements: Bisphenol-AF (4,4'-[2,2,2-trifluoro-1-trifluoromethyl)ethylidene]diphenol) and Bisphenol-F (4,4'-methylenediphenol). While probably not of significant concern in the electronics industry (unless you’ve replace BPA-based polycarbonates with resins based on either of these), manufacturers of certain plastic consumer products (e.g., water bottles) and thermal paper should take note.

More EU RoHS Update

Four phthalates were officially added to the RoHS Directive by Commission Delegated Directive (EU) 205/863. The restriction of the use of DEHP, BBP, DBP and DIBP comes into force on July 22, 2019 for all EEE except for Categories 8 and 9 (medical devices and monitoring/control instruments), which must follow the new restrictions as of July 22, 2021.

Yet Another RoHS?

The United Arab Emirates (UAE) proposed a RoHS-like regulation through the World Trade Organization on August 3. A sixty day comment period is now open. Product categories and basic technical requirements are essentially the same as EU RoHS (2011/65/EU). The regulation comes into force on January 1, 2018 for all categories of EEE except for Categories 8 and 9 (medical devices and monitoring/control instruments), which have until January 1, 2020 to comply. The 2018 date includes Category 11, which is still very poorly defined by the EU. So this inconsistency may merit some attention.

However, it’s not exactly that simple: products available on the market before publication of “this scheme in The Official Gazette” may no longer be sold after January 1, 2018. So the “in force” date actually depends on the date of publication of this regulation!

Another inconsistency is that the four phthalates that were recently added to the EU RoHS Directive will become restricted for categories 1-7, 10 and 11 on January 1, 2018; well before the EU in-force date mentioned above of July 22, 2019.

Finally, of possible concern are the Conformity Assessment requirements in Article 5, which include

  • a written Declaration of Conformity for each electrical equipment Model
  • submission of technical documents to the Emirates Authority for Standardization & Metrology (ESMA), including “Test reports”

Article 5 does not indicate under what circumstances the submission of technical documents is required; it could be as a pre-requisite of selling the product or obtaining “Emirates Conformity Assessment Scheme” (ECAS) registration (which must be done “within one year from the date of publication of this scheme in The Official Gazette”).

While clearly based on the EU RoHS Directive, there are many serious and significant inconsistencies with this draft regulation that should be of significant concern to any manufacturer selling products in UAE.

Contact

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

Mike Kirschner


Mike Kirschner

Mike Kirschner is a product environmental compliance and performance expert who provides advice and expertise to manufacturers in a variety of industries. His primary areas of focus include EU RoHS, the impact of EU's REACH regulation on article manufacturers, California’s Safer Consumer Products regulation, and performance standards like IEEE-1680.x for electronics. Mike helps manufacturers define, implement and troubleshoot internal management systems that result in compliant products, and assesses and monitors environmental regulations around the world on their behalf.

He contributed two chapters to the Governance, Risk, and Compliance Handbook, published by Wiley in 2008, and is featured in the critically acclaimed book, Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power. In 2009 he was appointed to the California EPA Department of Toxic Substance Control's Green Ribbon Science Panel. Prior to joining ENVIRON, Mike founded product lifecycle and environmental consultancy Design Chain Associates, LLC (DCA), where he served as president and managing partner. Before founding DCA in 2001, Mike spent 20 years in engineering and engineering management roles within the electronics industry with manufacturers including Intel and Compaq. He holds a BS in electrical engineering from Worcester Polytechnic Institute.

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