Tag Archives: REACH

EU REACH – 48 Substances to be Reviewed in 2015

ECHA has adopted a plan to evaluate 134 substances under the REACH regulation during the 2015-2017 timeframe. The plan, which is referred to as the Community rolling action plan (CoRAP), lists the substances that EU member states will be assessing and proposing as potential SVHCs for the Candidate List or other possible regulation under REACH. The plan contains 134 substances, 66 of which have been newly selected and 68 substances that are left over from the plan that was announced in March 2014.

Of the 134 substances, the intention is to evaluate at least 48 of the substances in 2016, another 48 substances in 2016, and 38 substances in 2017.

[1] ECHA press Release: http://echa.europa.eu/view-article/-/journal_content/title/evaluation-kicks-off-for-48-substances-in-2015

[2] ECHA proposal to the Member States: Draft Community Rolling Action Plan (CoRAP) update for years 2015-2017 http://echa.europa.eu/documents/10162/13628/corap_2015_2017_en.pdf

[3] For additional information on the March 2014 plan, see the ECD blog post at http://rohs.ca/blog/2014/03/28/march-26-2014-eu-identifies-120-substances-for-evaluation-as-possible-svhcs/

EU REACH – Consultation for Two New SVHCs

A public consultation on two new SVHC Candidate List proposals began on March 2, 2015 and will continue through April 16, 2015. The new substances proposed for addition to the SVHC Candidate List 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)
  • 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 isomers of [1] and [2] or any combination thereof]

Assuming that no major discrepancies are identified during the consultation, the new SVHCs will likely be added to the SVHC Candidate List in June 2015.

The IEC 62474 validation team is currently assessing these substances to determine if they are constituents of EEE. The first substance is specified as a combination of two phthalates (neither of which is an SVHC) with small quantity (above 0.3%) of DnHP — this substance description is likely to be a challenge for the EEE supply chain to deal with.

SVHC Threshold based on Components – ECJ Takes First Step in Ruling

The European Court of Justice has taken a first step in ruling that the REACH SVHC concentration threshold should be interpreted based on the “Once an Article, Always an Article” principle.

In its original guidance on reporting SVHCs in articles, the European Commission suggested that the 0.1% threshold should be based on the weight of the entire article as imported or as provided to the customer. However, six countries (Austria, Belgium, Denmark, France, Germany and Sweden) disagreed with this guidance. The dissenting countries argued that an SVHC that is above the 0.1% level in any individual article (component) within a product may pose a health or environmental risk and should trigger the reporting and communication obligations for the SVHC.

The difference in opinion between the two sides created a lot of ambiguity for industry, but industry generally followed the methodology given in the EC guidance document because of the sheer difficultly in meeting the obligations based on SVHC levels in each component in the product.

Legal proceedings were launched in France and are now forcing a resolution to the standoff. The European Court of Justice (ECJ), which has the final say in matters of EU regulatory interpretation, has been asked to rule on the question. As a first step toward a preliminary ruling, the Advocate General, an official legal advisor, has delivered his opinion. The Advocate General reviewed the regulatory text as written and found that there was no legal justification for the 0.1% w/w concentration to be applied to an article that is make up of many components that are themselves articles. He recommended that the preliminary ruling by the ECJ should interpret the REACH Article 33 communication obligations and REACH Article 7(2) notification to ECHA should be based on SVHC content in each original article (component) in the product.

The Advocate General’s opinion states:

V –  Conclusion

124. I therefore propose that the Court answer the request for a preliminary ruling as follows:

(1)      If the other conditions laid down in Article 7(2) of the REACH Regulation are satisfied,

(a)      the producer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own, but were made or assembled by other producers, is required to notify ECHA if a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) is present in the entire article above a concentration of 0.1% weight by weight (w/w); and

(b)      the importer of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to notify ECHA if a substance meeting the criteria laid down in Article 57 and identified in accordance with Article 59(1) is present in a component article above a concentration of 0.1% weight by weight (w/w).

(2)      The supplier of an entire article consisting of component articles which, despite being integrated into an entire article, retain a shape, surface or design of their own is required to provide information to recipients and, on request, consumers under Article 33 of the REACH Regulation on a substance meeting the criteria in Article 57 and identified in accordance with Article 59(1) if it is present in a component article above a concentration of 0.1% weight by weight (w/w) and relevant information is available to the supplier.

If the Advocate General’s opinion is accepted by the ECJ, the impact on industry will be significant. Even manufacturers that have been collecting SVHC information from suppliers may be impacted. The declaration of SVHC content in supplier parts is typically triggered based on 0.1% weight of the part provided by the supplier.  If the supplier part is itself composed of multiple articles, an SVHC in a subpart that exceeds the 0.1% threshold may be masked.

Many manufacturers would need to develop new material and SVHC risk assessment processes and collect new material declarations from their suppliers. Contact ECD Compliance for additional information on the impact of this ruling or for assistance in developing conformity assessment procedures.

 

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.

Background

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.