One tool I find extremely useful is Compliance & Risks’ C2P system. It helps me help my clients to stay on top of new regulations that impact their products, and sometimes their company, in their markets. I monitor it on behalf of clients that subscribe to the system and let them know when there’s something they need to review, along with some degree of assessment of the regulatory requirement and why it impacts them or their product (or, if it’s a proposal/bill, I provide some guidance on what they may be able to do to influence it).
A couple weeks ago I was reviewing updates and found that, on May 2, Mexico had issued a new mandatory “standard” called “Limitaciones y especificaciones sanitarias para el uso de los compuestos de plomo”, or, per C2P, “Official Mexican Standard NOM-004-SSA1-2013 Environmental health. Limits and health requirements for the use and marketing of lead compounds in consumer products.” The rule is focused on lead, but has a broad range of product targets. I engaged my colleague Dr. Idania Zamora to help translate and analyze this new NOM.
Section 4 lists categories of manufactured goods for which the use of lead is prohibited, and others where it is allowed in specific applications, but the two don’t overlap. Electronics as a general category is only listed in section 4.3.5, which is part of the section that describes allowed uses:
In the case of electrical and electronic equipment: in the coating material of facilities and equipment cables; in the glass of cathode ray tubes, electronic components and fluorescent tubes; in alloys; in high melting temperature type solders; in solders for servers, storage and storage array systems; in solders for network infrastructure equipment for switching, signalling, transmission, as well as network management for telecommunications and in ceramic electronic components.
This listing is suspiciously familiar; they have clearly taken some of the more broadly used lead exemptions from Annex III of the EU RoHS Directive, but have missed others (such as lead in glass for optical and filter applications, aka exemptions 13(a) and 13(b)). Does that say those exemptions are effectively disallowed in Mexico? And does that deny Mexico certain data and telecommunication products? Was this a conscious decision?
In addition, they have added an exemption for cable “coatings” in facilities and equipment.
The actual scope of what is meant by “electrical and electronic equipment” is unclear at this time, as well.
The law comes into force on May 2, 2015, but companies will have five years from that date to exhaust existing products containing lead already at the point of sale.
We will try to provide more information in the future about this regulation.
Note that there are already over a dozen jurisdictions besides the EU that have copied or otherwise based a local regulation on the EU RoHS Directive. None, except perhaps Switzerland, are 100% harmonized with the EU; most have not updated their list of exemptions to keep up with the EU’s expanding (and, in about 18 months, contracting) Annex III, and some (like California’s AB1109 and SB20/50) are referencing the now-repealed 2002/95/EC Directive. Until regulators in these markets spend the time to understand the products they are regulating and how they are being regulated, we can expect to see more unharmonized, and potentially unworkable, versions of RoHS come our way.
EU RoHS Update
In late May the European Commission issued eight Directives adding five new exemptions for Category 8 and/or 9 products, as well as adding a couple to Annex III. Some may appear to be familiar; in fact Directive 2014/69/EU re-enables the now expired Annex III 7(c)III exemption for lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC, but only for industrial monitoring and control instruments and only until the end of 2020 (not 2021 or 2024, which is when most exemptions for Category 9 will expire). The Commission would not allow expired exemptions to be renewed for Categories 8 and 9 only, so industry needed to reapply for the exemption.
Here are the new exemptions being added to Annex IV:
35. Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017. Expires on 21 July 2024. (Directive 2014/75/EU)
36. Lead used in other than C-press compliant pin connector systems for industrial monitoring and control instruments. Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021. (Directive 2014/74/EU)
37. Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:
(a) wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations;
(b) measurements of solutions where an accuracy of +/– 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following:
i. solutions with an acidity < pH 1;
ii. solutions with an alkalinity > pH 13;
iii. corrosive solutions containing halogen gas;
(c) measurements of conductivities above 100 mS/m that must be performed with portable instruments. Expires on 31 December 2018. (Directive 2014/73/EU)
38. Lead in solder in one interface of large area stacked die elements with more than 500 interconnects per interface which are used in X-ray detectors of computed tomography and X-ray systems. Expires on 31 December 2019. May be used after that date in spare parts for CT and X-ray systems placed on the market before 1 January 2020. (Directive 2014/71/EU)
39. Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:
(a) a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;
(b) a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:
i. a response time shorter than 25 ns;
ii. a sample detection area larger than 149 mm2;
iii. a multiplication factor larger than 1.3 × 103.
(c) a response time shorter than 5 ns for detecting electrons or ions;
(d) a sample detection area larger than 314 mm2 for detecting electrons or ions;
(e) a multiplication factor larger than 4.0 × 107.
The exemption expires on the following dates:
(a) 21 July 2021 for medical devices and monitoring and control instruments;
(b) 21 July 2023 for in-vitro diagnostic medical devices;
(c) 21 July 2024 for industrial monitoring and control instruments. (Directive 2014/70/EU)
40. Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments. Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021. (Directive 2014/69/EU)
And here are the new exemptions for Annex III:
- Directive 2014/72/EU adds exemption 41 to Annex III as follows:
- Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council). Expires on 31 December 2018
- Directive 2014/76/EU adds exemption 4(g) to Annex III as follows:
- Mercury in hand crafted luminous discharge tubes used for signs, decorative or architectural and specialist lighting and light-artwork, where the mercury content shall be limited as follows:
(a) 20 mg per electrode pair + 0,3 mg per tube length in cm, but not more than 80 mg, for outdoor applications and indoor applications exposed to temperatures below 20 °C;
(b) 15 mg per electrode pair + 0,24 mg per tube length in cm, but not more than 80 mg, for all other indoor applications. Expires on 31 December 2018
Dr. Idania Zamora is a senior associate in ENVIRON’s San Francisco office. Her email address isIZamora@environcorp.com.