Tag Archives: EU RoHS

EU – Scope Changes to the EU RoHS Directive

The European Commission has drafted an amendment to the EU RoHS Directive (2011/65/EU) updating the scope of the Directive to fix the various issues that have been identified since RoHS 2 was published in 2011.  This includes the provision in the Directive that prevents used medical devices, control and monitoring instruments and other EEE that did comply with the substance restrictions from being resold after July 2019.

The amendment will make the following changes to the Directive:

      • The July 2019 limitation on re-selling non-compliant re-used EEE (Article 2, paragraph 2) is deleted
      • An exclusion is added for Pipe organs
      • The definition of “non-road mobile machinery made available exclusively for professional use” is updated.
      • The requirement for category 11 “other EEE” to comply with the substance restrictions starting on 22 July 2019 is added to the end of paragraph 3 of Article 4. The revised paragraph will read:
        • 3. Paragraph 1 shall apply to medical devices and monitoring and control instruments which are placed on the market from 22 July 2014, to in vitro diagnostic medical devices which are placed on the market from 22 July 2016, to industrial monitoring and control instruments which are placed on the market from 22 July 2017 and to all other EEE that was outside the scope of Directive 2002/95/EC which is placed on the market from 22 July 2019.;
  • Category 11 “other EEE” put on the EU market before 22 July 2019 was added to the list of product categories that may be repaired/refurbished with non-compliant spare parts and cables (i.e., repair as originally sold).
  • For category 11 “other EEE”, the original Annex III exemptions are valid until 5 years from 22 July 2019
  • The statement “The Commission shall decide on an application for renewal of an exemption no later than 6 months before the expiry date of the existing exemption unless specific circumstances justify other deadlines.” In Article 5(5) is deleted.

The amendment is not official until it is published in the Official Journal of the EU.

Proposed Scope Changes to EU RoHS

Shortly after the EU RoHS 2 Directive was published in 2011, a few concerns were identified about some of the wording in RoHS 2 and its interpretation.

Some manufacturers in the medical devices industry raised a concern that the use of the term “made available on the market until 22 July 2019” in referring to substance restrictions for products newly in scope of RoHS 2 will prevent those products from being refurbished and then resold after 2019. The medical equipment industry is especially impacted in that it frequently refurbishes its products and then re-sells to health care providers that can’t afford the new equipment.

The language in RoHS 2 also missed an exclusion for spare parts for products that are newly in scope (other than medical devices and monitoring and control instruments).

The European Commission plans to publish an amendment to the scope of the RoHS 2 Directive to address the issues. In an Inception Impact Assessment , the Commission indicates that its preferred option is to:

  • remove the “made available” clause and simply provide a requirement that all other EEE that did not previously need to be compliant, must be compliant by 22 July 2019.
  • Add in a spare parts exclusion for such products.

In this way there are no limitations in refurbishing products or in repairing products that were legally put on the market.

Canadian Mercury Regulations to Impose Tight Restrictions on Mercury in Batteries

In our December post titled “Products Containing Mercury Regulations published in Canada,” we discussed the scope and general prohibitions and exemptions of the recently published Canadian “Products Containing Mercury Regulations (SOR/2014-254)“. In this second article on the Regulations, we examine some of the technical aspects of the Regulations including the maximum concentration limits and how these compare with the EU RoHS Directive and the EU Battery Directive.

Maximum Concentration Limit

The concentration of mercury allowed in the Canadian Regulations aligns with the EU RoHS restriction of 0.1% mercury in homogeneous materials. This allows EEE manufacturers and importers to leverage their conformity assessment procedures and to use existing supplier material declarations, test reports and other technical documentation (as per EN 50581).


For batteries, the maximum concentration levels specify the same numerical percentage as in the EU Battery Directive; however, there are important differences in the basis of calculation. The Canadian mercury regulations reference the weight of mercury in homogeneous materials whereas the weight of the entire battery is the basis for calculation in the EU Battery Directive.

Canadian Products Containing Mercury Regulations

(l) a battery, other than a button cell battery, that has a mercury concentration of 0.0005% or less by weight in homogeneous materials; [are excluded]

EU Battery Directive

1.(a) all batteries or accumulators, whether or not incorporated into appliances, that contain more than 0,0005 % of mercury by weight; and [are prohibited]

As a result, the Canadian Regulations are much stricter than the EU Directive and battery manufacturers may have more difficulty in verifying conformity to this requirement.

Button Cell Batteries

Both Canadian and EU restrictions provide short-term allowances for mercury in button cell batteries that phase out in 2015.  The Schedule in the Canadian Regulations provides an exemption for up to 25mg per button cell battery that expires on December 31, 2015. In the EU Battery Directive, the mercury prohibitions in button cell batteries are specified in Article 4, paragraph 2, allowing up to 2% mercury by weight of the battery:

4(2). The prohibition set out in paragraph 1(a) shall not apply to button cells with a mercury content of no more than 2 % by weight until 1 October 2015.

The Canadian Regulations set the long-term mercury threshold at 0.0005% based on the weight of each homogeneous material; whereas the EU Battery Directive sets the threshold based on the weight of the entire battery. The Canadian Regulations specify the concentration limits in subsections 2(m) and 2(n).

(m) beginning on January 1, 2016, a button cell battery that has a mercury concentration of 0.0005% or less by weight in homogeneous materials; [are excluded]

(n) from January 1, 2016 until December 31, 2019, a button cell battery that is incorporated into a medical device that is intended to remain in the body for at least 30 consecutive days; [are excluded]

The Canadian Regulations provide an exclusion for button cell batteries in implanted medical devices; whereas, the EU Battery Directive provides an broader exclusion to the mercury prohibition for all portable batteries in medical devices.


An earlier draft of the Canadian mercury regulations proposed mandatory testing of products containing mercury; however this requirement was removed in the final regulations (to the relief of manufacturers and importers).

Future Articles on the Mercury Regulations

In future articles examining the Products Containing Mercury Regulations, we will discuss

  • the mercury exemptions provided by the Regulations and how the exemptions compare to those provided in the EU RoHS Directive
  • what if your product requires mercury, but there is no exemption listed — how manufacturers and importers may apply for a temporary permit
  • marking, labeling and reporting requirements for products that contain mercury above the maximum concentration limit
  • accreditation of test labs

ECD Compliance provides manufacturers and suppliers with services to track global environmental product requirements and assess the impact to their products and markets, including the Canadian Products Containing Mercury Regulations.

The Products Containing Mercury Regulations (SOR/2014-254) is available from the Canada Gazette.


Strategic Roadmap for International Environmental Standards provides Insight for Manufacturers

The IEC technical committee responsible for environmental standards for the EEE industry (IEC/TC111) recently updated its strategic roadmap to highlight areas that have emerging needs for international standardization. This roadmap provides EEE manufacturers and suppliers with insight into areas with emerging conformity requirements and where more well defined methods and/or guidance are needed. These requirements are typically driven by new regulations or divergent requirements that are causing trade barriers or supply chain issues.


In 2004, the International Electrotechnical Commission (IEC) created technical committee TC111 to develop internationally recognized standards to assist manufacturers in complying with emerging environmental regulations of Electrical and Electronic Equipment (EEE) and other voluntary initiatives. The use of harmonized standards reduces uncertainty and risk for international trade and helps enable communication and consistency across a global supply chain. IEC standards are recognized by the World Trade Organization (WTO) and member countries of the WTO have agreed to harmonize their national standards with IEC standards wherever possible.

The Role of IEC Environmental Standards

Several of the IEC/TC111 standards are commonly used for assessing compliance to regulations such as EU RoHS (and other global RoHS regulations), EU REACH (declaration of SVHCs), WEEE, and emerging carbon footprint and environmental footprint regulations. The standards provide tools for material declaration, assessing restricted substance controls, analytical testing, environmentally conscious design, etc.

For a list of all IEC/TC111 published standards and standards under development, see the RoHS news post IEC/TC111 – Environmental standardization for electrical and electronic products and systems.

IEC is often not the first standards organization to create a standard on a specific topic, but it can help harmonize approaches across national or regional standards.

What’s New in the Revised Roadmap

The standardization topics in the roadmap are organized into seven categories:

  • Chemical Substance
    • Standardized substance testing methodologies
    • Maintenance and improvement activities related to material declaration
    • Demonstration of due diligence for substance restriction conformity.
    • Definition of “low halogen” materials used in electrotechnical products.
  • Environmental Conscious Design (ECD)
    • Environmentally Conscious Design (the intention is to progress IEC 62430 to a dual logo ISO/IEC standard that is applicable to all products)
    • Product Category Rules (for full LCA of multiple environmental impacts)
  • Recovery/Recycling/Reuse
    • Treatment, collection and logistics of Waste Electrical and Electronic Equipment (WEEE)
  • Greenhouse Gases (GHG)
    • Methodologies and rules for Carbon footprint calculation of EEE
    • Electrotechnical specific secondary data
  • Resource efficiency
  • SMART Cities
  • Environmental Product Declarations and Eco labels
    • Environmental Performance Criteria that may be used in eco labels used for green electronics purchasing
    • Product Category Rules (for full LCA of multiple environmental impacts)

The IEC/TC111 roadmap is included in the Strategic Business Plan (SBP) which may be downloaded from the IEC website.

The standardization topics under Environmental Product Declarations (EPD) and Eco labels are newly added and have been gaining considerable interest.

Environmental Performance Criteria

The standardization area of “Environmental Performance Criteria” is in response to the plethora of eco label criteria emerging around the world. Environmental labelling programs and registries specify criteria for assessing environmental performance of a variety of electrical and electronic products. Programs exist for computers, monitors, imaging equipment, TVs, tablets, phones, and many other EEE products. These programs give purchasers an easy, predefined mechanism to set green procurement requirements. However, many of the environmental labelling programs have overlapping scope and sometimes establish inconsistent (or even incompatible) environmental criteria. Inconsistencies can create significant challenges for manufacturers and suppliers who try to optimize environmental performance of products and manufacturing operations simultaneously for all markets around the world.

An IEC International Standard on Environmental Performance Criteria would enable users, ecolabelling bodies and registries, manufacturers and supplies (from around the world) to leverage and build upon a harmonized set of baseline environmental performance criteria. A harmonized set of baseline criteria provides benefits to all stakeholders.

Product Category Rules (PCR) for Life Cycle Assessment (LCA)

An International standard for EEE product category rules has also been gaining interest. Conducting LCAs that provide meaningful information is challenging for the electronics industry.  With a complex supply chain and significant impacts from raw material extraction and part manufacturing in several environmental impact categories, the assumptions made with respect to setting scope, boundary conditions, cut-off rules, product use, electricity generation, and the use of primary vs. secondary data are very important in the usefulness and comparability of the results. This is particularly important as governments around the world tighten rules to avoid green washing with environment claims.

A baseline set of internationally harmonized PCR across the electrotechnical industry can provide a significant opportunity for the industry to better utilize the results of a LCA.  The International Standard may also provide rules and guidance for the development of supplemental sector specific PCR that may be needed for specific types of products. A baseline PCR across the entire EEE industry will also provide consistency for the supply chain which may be providing parts and materials to a number of different sectors.

ECD Compliance uses published and emerging International Standards to support manufacturers and suppliers in meeting current and future product environmental compliance and sustainability requirements. We can also provide a window for your organization into emerging environmental standards.  For additional information, contact ECD Compliance.

Future posts will examine some of these standardization areas in more detail.