Tag Archives: Restricted Substances

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.

USA – TSCA Reform Bill Signed into Law

The Frank R Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016 by President Obama. The Act modernizes the dated U.S. Toxic Substances Control Act (TSCA) for the first time in 40 years. The EPA is challenged with an aggressive schedule, especially in the first year.

The U.S. EPA has setup a resource page for information on the Lautenberg Act, including a overview of the Act:

The new law, which received bipartisan support in both the U.S. House of Representatives and the Senate, includes much needed improvements such as:

  • Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines;
  • New risk-based safety standard;
  • Increased public transparency for chemical information; and
  • Consistent source of funding for EPA to carry out the responsibilities under the new law.

On June 30, 2016, the EPA posted an implementation plan for the first year of operation under the revised TSCA. Short term implementation focuses on specific objectives that are explicitly specified in the Act. These relate to:

  • Premanufacture notices (PMNs) and Significant new Use Notices (SNUNs)
  • Review of Confidential Business Information; rules and names for confidential chemicals
  • Completion of chemical risk assessments previously underway including addressing risks from trichloroethylene (TCE), methylene chloride (MC) and N-methylpyrrolidone (NMP)
  • Develop of processes for initial risk evaluation, prioritization, risk evaluation, fees, and chemical inventory
  • Creation of a science advisory committee on chemicals
  • Scope of initial risk evaluation, annual plan for risk evaluations; identify first 10 chemicals for assessment.
  • Mercury inventory, export ban, and reporting rule
  • Small business definitions
  • Alternative testing methods strategy

RoHS Amendment adding Phthalates to Restricted Substances is Published

The European Delegated Directive (EU) 2015/863 officially adding the four (4) Phthalate substances to the EU RoHS Directive was published today, June 4, 2015.  The new phthalate restrictions take effect beginning July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments). Category 8 and 9 products have an additional 2 years and need to comply by July 22, 2021. EEE manufacturers and their suppliers now have just over four years to prepare.

The amendment adds the four phthalates shown below to Annex II (Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials) of the the RoHS Directive . A maximum concentration value of 0.1% w/w in homogeneous material was specified for the phthalates in the amendment.

Four Phthalate Substances to be Added to RoHS Directive

Substance NameCAS NumberMaximum Concentration
in homogeneous material
Bis(2-ethylhexyl) phthalate (DEHP)117-81-70.1%
Benzyl butyl phthalate (BBP)85-68-70.1%
Dibutyl phthalate (DBP)84-74-20.1%
Diisobutyl phthalate (DIBP)84-69-50.1%

Spare Parts and Cables

The official publication of the amendment was delayed by a few months to allow the European Commission time to add verbiage clarifying the implication on cables and spare parts.  This new text aligns with the general RoHS intention to allow products to be repaired using the same parts that were used in the original product when if was first put on the EU market.  The published amendment states:

The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.

Phthalates in Electrical/Electronic Toys

The amendment is also explicit that the phthalates in toys restriction in Annex XVII of the REACH regulation takes precedence over the maximum concentration levels in the RoHS Directive.

What’s the Impact? How to Proceed?

The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing  the parts and materials that require substitution.  However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.

In electrical and electronic equipment (EEE), DEHP is generally considered to be the most commonly used of the four phthalates. DBP and BBP also have known applications; whereas DIBP is considered to have minimal usage within the EEE supply chain.

The results of a study published in 2010 at the IPC APEX conference “Where are REACH SVHC in Electronic Products and Parts?” may provide some insight to the use and prevalence of these substances.  The study investigated and compiled analytical test results for the initial batch of SVHCs added to the REACH Candidate List (including 3 of the phthalates just added to RoHS). The analytical testing was performed in Asia, North America, and Europe on EEE and materials typically used in EEE.  DEHP was detected above the SVHC threshold (0.1% wt/wt in the article) in 64 of 391 testing results (16%). The study was focused on the REACH SVHC threshold which is based on articles.  However, had the study considered a concentration threshold based on homogeneous material, the number of products above the threshold would likely have been much higher.

In the time since 2010, many manufacturers that have been trying to eliminate SVHCs from their product have removed the phthalates from external cables (where they are above 0.1% in the article); but DEHP may still be present in internal cables which are relatively small and for which the phthalate content did not trigger the 0.1% threshold based on imported article.

Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. The amendment to the RoHS Directive is posted on the Official Journal of the EU. ECD Compliance provides services to track environmental regulations and can assist in upgrading your RoHS program to address the phthalate restrictions.

China RoHS 2 Proposal – May 2015

China RoHS 2 is once again moving forward.  An updated draft regulation titled “Management Methods for the Restriction of the Use of Hazardous Substances in Electric and Electronic Products (Draft for Comments)” was released on May 18 for public comment. It reveals several changes compared to the previous 2013 version.

The draft regulation is applicable to the production, sale, and import of electrical and electronic products. Unlike the original China RoHS, the draft does not provide an exclusion for products that are intended for export (presumably to help ensure that exported products meet the RoHS restrictions imposed by other countries).

Similar to the previous China RoHS 2 draft, the scope of products (compared to the original China RoHS) is expanded to “Electrical and electronic products”, but, this time, with an explicit exclusion for power generation, transmission and distribution equipment. The definition of “Electrical and electronic products” refers to devices and accessory products which function by means of current or electromagnetic fields. The definition utilizes the same voltage limits used by the EU RoHS Directive — rated working electrical voltages of no more than 1500 volts direct current and 1000 volts alternating current.

Hazardous substances are defined as the six original RoHS substances, with a seventh entry for other harmful substances, leaving the door open to restrict additional substances.

The draft regulation maintains the marking and communication obligations of the original China RoHS, including the “environmental protection use period” and the table identifying harmful substances and their location in the product. However, the requirements for the table of harmful substances has been clarified/expanded.

Similar to the original China RoHS, a catalog will list products that are subject to substance restrictions.  The catalog will be developed and maintained by the Ministry of Industry and Information Technology (MIIT) in consultation with other departments.

A conformity assessment system will be established for ensuring restricted substance conformity of products that are listed in the compliance management catalog. This replaces the CCC certification specified in the original China RoHS.

Requirements on product packaging, which were removed from earlier China RoHS 2 proposals, have now been added back in. The packaging for all manufactured or imported electrical and electronic products must meet all applicable standards and laws. Manufacturers and importers should also adopt the use of materials that are non-hazardous, easily biodegradable and/or facilitate recycling/reuse.

Section III on “Punitive Provisions” identifies requirements that are subject to penalties if not met, including substance restrictions, labelling of the product with the environmental protection use period, names and content of hazardous substances, and packaging conformity. The paragraph on the hazardous substances table is particularly detailed, suggesting that MIIT expects producers and importers to be in full compliance and not take any short-cuts.

The draft is available from the Legislative Affairs Office of the  State Council P.R. China (in Chinese). The public comment period ends June 17, 2015.

For additional information, contact ECD Compliance. Clients will be receiving additional analysis and discussion of potential impact of the proposal in the next environmental report.

 

Singapore Clarifies RoHS Proposal

The Singapore National Environment Agency (NEA) is proposing a Singapore RoHS regulation. The proposal aligns with the EU RoHS Directive, but initially targets only 6 common consumer product categories. The six product categories targeted for RoHS compliance are: Mobile Phones, Mobile computers, Refrigerators, Air conditioners, Panel TVs and Washing Machines. A NEA study has found that 95% of these products are already compliant and intends to ensure compliance of all such products that are sold in Singapore. The proposal suggests that a one-year grace period (transition time) will be provided for manufacturers and importers to comply with the restrictions from the date the regulation is gazetted.

In their response to a public consultation on the proposed regulation, the NEA clarified that

  • Batteries would be excluded from the scope of Singapore RoHS (same as EU RoHS)
  • The RoHS exemptions would be aligned with EU RoHS (Annex III) and updated regularly to remain in alignment.
  • Manufacturers and importers of EEE will be required to submit a RoHS Declaration of Conformity prior to selling EEE product in Singapore (this is different from the enforcement approach employed in the EU).
  • Non-RoHS EEE may still be manufactured in Singapore for export; however, the manufacturer will need to apply for a hazardous substance licence from NEA.

 

RoHS 2 Phthalates Restriction Clarified for Spare Parts and Cables

The European Commission has clarified the impact of the upcoming RoHS 2 Phthalates restrictions on spare parts and cables for products that were put on the EU market before the new substance restrictions come into effect.  The clarification was made March 13, 2015 in response to comments the EC had received to their WTO notification of the draft amendment adding the four phthalate substances to Annex II of the RoHS Directive (2011/65/EU).

The Commission proposed the following draft recommendation to be included in the ANNEX II amendment:

“The restriction of DEHP, BBP and DBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of the EEE of ANNEX I categories 1-7, 10 and 11 that is placed on the market before 22 July 2019, and the EEE of ANNEX I categories 8 and 9 that is placed on the market before 22 July 2021.”

ECD Compliance is providing services to assist manufacturers with implementing the phthalates restrictions in supply chain management and manufacturing operations efficiently and cost effectively.

 

 

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.

 

New Substances for RoHS Directive Notified to WTO

The European Commission moved forward with its update of the List of Restricted Substances in the RoHS Directive, Annex II. The Commission has notified the World Trade Organization that the four phthalate substances will be added to the RoHS substance restrictions.  The restrictions take effect beginning in July 22, 2019 for all EEE except category 8 (medical devices) and category 9 (monitoring and control instruments) which will have an additional 2 years and need to comply by July 22, 2021. This provides most EEE manufacturers and the global supply chain with four and a half years to prepare.

Four Phthalate Substances to be Added to RoHS Directive

Substance NameCAS NumberMaximum Concentration
in homogeneous material
Bis(2-ethylhexyl) phthalate (DEHP)117-81-70.1%
Benzyl butyl phthalate (BBP)85-68-70.1%
Dibutyl phthalate (DBP)84-74-20.1%
Diisobutyl phthalate (DIBP)84-69-50.1%

The maximum concentration value for the phthalates will be 0.1% w/w in homogeneous material.

The four phthalates are already listed on the REACH SVHC Candidate List — this gives manufacturers that have REACH SVHC information from their suppliers a head start in assessing  the parts and materials that require substitution.  However, the different basis for calculating concentration level between REACH and RoHS (article vs. homogeneous material) will undoubtedly create some surprises.

Additional information on RoHS 2 compliance and RoHS 2 Technical Documentation is available. ECD Compliance provides services to assess your product requirements for compliance to environmental regulations and to implement compliance procedures.

The notified Directive is available on the WTO website.