Category Archives: nl2019q1

EU – REACH Annex XVII restriction of Phthalates

Commission Regulation (EU) 2018/2005[1] revised the Phthalates entry in REACH Annex XVII to cover most products. The restriction includes the four phthalates: DEHP, DBP, BBP, DIBP. There are some exclusions for certain products that are already subject to phthalate restrictions.

The regulation was published on December 18, 2018 with restrictions that start to come into effect on July 7, 2020.  An extended transition time is provided for motor vehicles and aircraft (until 2024). Exclusions with no time limit are also provided for measuring devices for laboratory use, medical devices, and packaging of medicinal products – details about the exclusions are provided in the regulation.

For products that are within the scope of the new restrictions, the concentration threshold for the sum of all four phthalates is 0.1% by weight of the plasticised material.

[1] REACH Annex XVII phthalate restriction, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R2005&from=EN

EU – Ten EU RoHS Exemptions Published

On February 5, 2019, the European Commission published the delegated directives for renewal of exemptions 7(c)-II, 7(c)-IV, 8(b), 15, 18(b), 21, 29, 32, and 37 and new exemption 42. The table includes the Index #, descriptions and expiry to replace the existing exemptions (previous wording of exemption is shown in the right-most column). The revised exemptions take effect starting March 1, 2020.

Manufacturers should take a close look at the renewed exemptions with respect to their products.  Several applications that were previously allowed to use the restricted substance are no longer exempted once the renewals take effect next year. Other applications are being phased out on an accelerated timeline.  ECD Compliance is working with manufacturers and suppliers to identify impacts and risks in the supply chain and manufacturing processes.

Table 2: Ten EU RoHS Exemptions Published

Delegated Directives Published on February 5, 2019Previous Annex III Wording for comparison
Index #Exemption DescriptionExpiry
In Annex III, entry 7(c)-II is replaced by the following:
7(c)-IILead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higherDoes not apply to applications covered by point 7(c)-I and 7(c)-IV of this Annex.
Expires on:
— 21 July 2021 for categories 1-7 and 10;
— 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
— 21 July 2023 for category 8 in vitro diagnostic medical devices;
— 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher
In Annex III, entry 7(c)-IV is replaced by the following:
7(c)-IVLead in PZT based dielectric ceramic materials for capacitors which are part of integrated circuits or discrete semiconductorsExpires on:
—21 July 2021 for categories 1-7 and 10;
—21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
—21 July 2023 for category 8 in vitro diagnostic medical devices;
—21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead in PZT based dielectric ceramic materials for capacitors being part of integrated circuits or discrete semiconductors
In Annex III, entry 8(b) is replaced by the following:
8(b)Cadmium and its compounds in electrical contactsApplies to categories 8, 9 and 11 and expires on:
— 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
— 21 July 2023 for category 8 in vitro diagnostic medical devices;
— 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Cadmium and its compounds in electrical contacts
8(b)-ICadmium and its compounds in electrical contacts used in:
—circuit breakers,
—thermal sensing controls,—thermal motor protectors (excluding hermetic thermal motor protectors),
—AC switches rated at:
—6 A and more at 250 V AC and more, or
—12 A and more at 125 V AC and more,
—DC switches rated at 20 A and more at 18 V DC and more, and
—switches for use at voltage supply frequency ≥ 200 Hz.
Applies to categories 1 to 7 and 10 and expires on 21 July 2021Cadmium and its compounds in electrical contacts
In Annex III, entry 15 is replaced by the following:
15Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packagesApplies to categories 8, 9 and 11 and expires on:
— 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
— 21 July 2023 for category 8 in vitro diagnostic medical devices;
— 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages
15(a)Lead in solders to complete a viable electrical connection between the semiconductor die and carrier within integrated circuit flip chip packages where at least one of the following criteria applies:
— a semiconductor technology node of 90 nm or larger;
— a single die of 300 mm2 or larger in any semi­conductor technology node;
— stacked die packages with die of 300 mm2 or larger, or silicon interposers of 300 mm2 or larger.
Applies to categories 1 to 7 and 10 and expires on 21 July 2021.Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages
In Annex III, entry 18(b) is replaced by the following:
18(b)Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb)Expires on:
—21 July 2021 for categories 1-7 and 10;
—21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
—21 July 2023 for category 8 in vitro diagnostic medical devices;
—21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb)
18(b)-1Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipmentApplies to categories 5 and 8, excluding applications covered by entry 34 of Annex IV, and expires on 21 July 2021.
In Annex III, entry 21 is replaced by the following:
21Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glassesApplies to categories 8, 9 and 11 and expires on:
— 21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
— 21 July 2023 for category 8 in vitro diagnostic medical devices;
— 21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses
21(a)Cadmium when used in colour printed glass to provide filtering functions, used as a component in lighting applications installed in displays and control panels of EEEApplies to categories 1 to 7 and 10 except applications covered by entry 21(b) or entry 39 and expires on 21 July 2021.
21(b)Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glassesApplies to categories 1 to 7 and 10 except applications covered by entry 21(a) or 39 and expires on 21 July 2021.
21(c) Lead in printing inks for the application of enamels on other than borosilicate glassesApplies to categories 1 to 7 and 10 and expires on 21 July 2021.
In Annex III, entry 29 is replaced by the following:
29Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC (*1)Expires on:
—21 July 2021 for categories 1-7 and 10;
—21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
—21 July 2023 for category 8 in vitro diagnostic medical devices;
—21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC
(*1) Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36).
In Annex III, entry 32 is replaced by the following:
32Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubesExpires on:
—21 July 2021 for categories 1-7 and 10,
—21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments,
—21 July 2023 for category 8 in vitro diagnostic medical devices,
—21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes
In Annex III, entry 37 is replaced by the following:
37Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass bodyExpires on:
—21 July 2021 for categories 1-7 and 10;
—21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
—21 July 2023 for category 8 in vitro diagnostic medical devices;
—21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.
Lead in the plating layer of high voltage diodes on the basis of a zinc borate glass body
In Annex III, entry 42 is added:
42Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:
—with engine total displacement ≥ 15 litres;
or
—with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.
Applies to category 11, excluding applications covered by entry 6(c) of this Annex.

Expires on 21 July 2024.
n/a

 

EU – REACH Candidate List Updated with Six SVHCs

On January 15, 2019, the European Chemical Agency (ECHA) added six additional substances to the EU REACH Candidate List. The new SVHC entries are listed in Table 1. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – SVHCs that are potential EEE constituents are shown with their typical EEE applications.  There is now a total of 197 SVHC entries on the REACH Candidate List.

The full REACH Candidate List is available on the ECHA website[1].

Table 1: REACH Candidate List - Six New SVHCS

NameDescriptionEC no.CAS no.Typical EEE Applications
1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one3-benzylidene camphor; 3-BC239-139-915087-24-8n/a
2,2-bis(4'-hydroxyphenyl)-4-methylpentane401-720-16807-17-6White crystalline powder, Raw material for epoxy resins, Raw materials for polycarbonate resin, Thermal paper, Chemicals, Surface coatings, Inks, Adhesives, Synthetic resin additives, Liquid crystal materials, Photosensitizers, Information recording agents, Engineering plastic materials, Electronic functional materials, Optical functional materials; may be used as substitute for BPA
Benzo[k]fluoranthene205-916-6207-08-9Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Fluoranthene205-912-4206-44-0; 93951-69-0Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Phenanthrene201-581-5January 8, 1985Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Pyrene204-927-3129-00-0; 1718-52-1Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers

[1] REACH Candidate List, http://echa.europa.eu/candidate-list-table

EU – Survey Finds Lack of Information on SVHCs in Articles

An EU survey (conducted by AskREACH pan-European project) found that nearly half of companies that responded (174 EU article manufacturers) are not able to provide SVHC information.  It also found that 43% of companies did not have an IT solution to collect and manage information on SVHCs.

The survey report is available on the AskREACH website[1].

Despite the small number of companies participating, the survey results add fuel to the fire that regulatory intervention and market driven pressure is needed to prompt all EU manufacturers, importers, distributers, and sellers to track and provide SVHC information.

[1] AskREACH survey, https://www.askreach.eu/many-companies-not-informed-about-svhcs-in-their-articles/

EU – ECHA/Standards Meeting on SVHC in Articles Database

A special standards development meeting was hosted by IPC in Genoa, Italy on November 19, 2018 to discuss material declaration requirements relating to the ECHA SVHC in articles database that will be coming online in 2020. A representative from ECHA attended the meeting to discuss the information that ECHA currently foresees manufacturers will need to submit into the database.   Representatives from material declaration standards IPC-1754, IC-1752A and IEC 62474 attended the meeting.

Most of the meeting was spent with the ECHA representative describing their expectations on data requirements, answering questions, and standards developers discussing how current industry material declaration practices could support the database (and where there are significant gaps).

Background

The database is mandated by the revised Waste Framework Directive (WFD) published in June 2018.  Product manufacturers, importers, distributors, retailers and other actors manufacturing or selling products in the EU will be required to submit information about the SVHC content in their products into the central database starting in January 2021. A submission will only be required if the product contains an SVHC above the 0.1 mass percent of article threshold. However, many complex electronic products, subassemblies, and components contain one or more SVHC(s) and will need to be registered in the database.

Based on the proposed scenario document provided by ECHA in mid September, compiling the information will be a challenge for many companies and could potentially reveal confidential business information (CBI). Industry has been pushing back, suggesting that the proposed data submission requirements go beyond the requirements specified in REACH Article 33 and the WFD.

ECHA Presentation on Data Requirements

Most of the morning was spent with the ECHA representative presenting background information on the ECHA scenario and answering questions from participants.

The ECHA representative at the meeting presented an interesting argument trying to justify the information in the scenario document by taking words or phrases from the text of REACH Article 33 and describing the implications.  Such words/phrases included supplier of the article, substance,  concentration about 0.1%,recipient and sufficient information.

ECHA is recommending that an article-based approach is needed with a unique identifier and other information about the article with the SVHC information.  ECHA stated that:

“Aggregation of data can only be performed if the data is collected more detailed than the aggregation need”.

 

Moving Forward

ECD Compliance’s impression from the meeting is that ECHA is becoming aware of the challenges in compiling the proposed information given practical realities such as a global supply chain, multi-sourcing of parts, and confidential business information (CBI). As a result of the feedback and discussions that have taken place, ECHA is working on updating its scenario document. However, ECHA was also clear in stating that the mandate for the database is now cast in law and will move forward in a manner that meets the needs of consumers and recyclers. Given the short timeframe to develop the database, ECHA intends to repurpose an existing database, most likely the European Poison Centre database.

ECHA intends to specify its own format for submitting information into the database – despite several standards development groups promoting the use of an existing material declaration standard. ECHA will write a new module for their IUCLID chemical system to support the SVHC in articles submissions. Their intention is that the interface will allow automated (computer to computer) submissions into the database (this will be important given that current manual submissions into IUCLID can take a couple hours to complete).

Open Issues

The ECHA proposal that all database submissions must identify the article (first article) containing the SVHC and the concentration range is still an open issue.  Many REACH declarations and/or material declarations of supplier parts and subassemblies do not identify the exact location of the SVHC and only indicate that an SVHC is present. One suggestion raised during the meeting was an approach whereby SVHCs would be related to an assembly or functional unit of a product instead of the first article (this would be similar to the way that the China RoHS declaration works). However, there was no indication that this would be acceptable to ECHA.

Another issue is the unique identifier and how it is generated and used.

There was also good discussion on the reporting challenges posed by multi-sourced parts, whereby similar parts from different suppliers may have different SVHC constituents.  This creates a challenge for reporting – a manufacturer could declare a worst-case sum of all SVHCs across all parts, but this results in over reporting.

For safe use information, ECHA is thinking about creating a standard list of safe use phrases that could be used for submission into the database.

Impact on EEE Manufacturers

Given that many EEE products contain SVHCs, the EU SVHC in articles database will be a significant challenge and overhead for many EEE manufacturers.  Questions are still being raised as to whether the information in the database will have any practical usefulness to consumer and recyclers as mandated. However, it seems that one of the EU’s objectives in implementing the database is to prompt manufacturers to expedite removal of SVHCs from their products. With lead reportable as an SVHC in the database, we may see some product and component manufacturers try harder to eliminate the use of these exemptions.

For additional information on the upcoming requirements of the ECHA SVHC in articles database or how to collect the required information from suppliers, contact ECD Compliance.

EU – Undecafluorohexanoic acid Withdrawn as SVHC Candidate

On December 13, 2018, the substance Undecafluorohexanoic acid and its ammonium salt (CAS no 307-24-4) was withdrawn from consideration as a Candidate List SVHC.  The Validation Team for IEC 62474 had already determined that Undecafluorohexanoic acid has potential uses in EEE and the substance would have been added to the IEC Declarable Substances List if the substance were added to the Candidate List.

Given the withdrawal, Undecafluorohexanoic acid will not be added to the IEC 62474 DSL at this time. For additional information on IEC 62474, see the blog at https://rohs.ca/iec62474

EU – Adopts Changes in REACH for Nanoform Substances

On December 3, 2018, the EU adopted an amendment to the REACH regulation to address substances that are in nanoform.  The lack of a specific regulatory definition and requirements for nanoform substances has been a known gap in the REACH regulation since it came into effect over ten years ago.  Substances in their nanoform often have different human health and environmental impacts than the same substances in their conventional forms.  But the difficultly in coming up with a suitable definition and information disclosure requirements has been a challenge.

The REACH amendment to address nanoforms of substances (Commission Regulation (EU) 2018/1881) is generally described as not being perfect, but it’s a starting point to move forward.  The amendment is available in the official journal[1]. The new requirements come into effect starting in 2020.

Impact on EEE Manufacturers

The new REACH requirements are most relevant to EU manufacturers and importers of nanoform substances.  This will impact only a very small fraction of the EEE industry that directly manufactures or use nanoform substances (such as some component manufacturers and their suppliers).

However, this does start to lay the ground work for identifying nanoform substances as SVHCs on the REACH Candidate List – which will in turn impact sub-assembly and finished product manufacturers. Given the prevalence of nanomaterials in electronics and that their use is often considered a trade secret, this will be a future challenge for the entire industry.

[1] REACH amendment for nanoforms, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018R1881&from=EN

Canada – Publishes Asbestos Restrictions

On October 18, 2018, Canada published the Prohibition of Asbestos and Products Containing Asbestos Regulations (SOR/2018-196). The tight restriction of asbestos use is not surprising, but the lack of a specific threshold for some aspects of the regulation is causing concern among some EEE manufacturers.

Paragraph 4 on import, sale or use and paragraph 5 on manufacture states that:

4 Subject to sections 7 to 21, a person must not import, sell or use

  • (a) processed asbestos fibres;
  • (b) a product containing processed asbestos fibres unless those fibres are the result of the degradation of asbestos integrated into a product, a structure or infrastructure; or
  • (c) a consumer product containing asbestos in greater than trace amounts.

5 A person must not manufacture

  • (a) subject to section 8, a product containing processed asbestos fibres unless those fibres are the result of the degradation of asbestos integrated into a product, a structure or infrastructure before the coming into force of these Regulations; or
  • (b) a consumer product containing asbestos in greater than trace amounts.

The complication is that bullet 4(b) suggests an absolute ban on processed asbestos fibres except due to degradation.  This creates a challenge with supplier declarations and in testing for compliance.

The restriction on consumer product specified in bullet 4(c) allows for trace amounts.  Environment Canada has published a separate guidance document[1] on the regulation to try to provide some clarification; however, the use of slightly different terminology in the guidance document versus the regulation creates some additional confusion.

The full text is available on the Justice Laws website[2]. The regulation comes into force on December 30, 2018.

Impact on EEE Manufacturer

Asbestos has been used in several EEE products that generate heat and it can occur in trace quantities in other products.  Given that the regulation doesn’t provide a precise threshold, some EEE manufacturers may decide to implement restrictions and supply chain requirements based on not “intentionally added”.

[1] Environment Canada Guidance on trace amounts of asbestos, https://www.canada.ca/en/environment-climate-change/services/management-toxic-substances/list-canadian-environmental-protection-act/asbestos/trace-asbestos-consumer-products-guidance.html#toc1

[2] Canada Asbestos regulation, https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-196/FullText.html

UAE – Confirms that UAE RoHS Includes B2B Products

On November 15, 2018, the Emirates Authority For Standardization & Metrology issued an updated guidelines document confirming that the scope of UAE RoHS includes B2B (business to business) products. The guidance suggests that a simplified process for a certificate of conformity is being provided for B2B products; however, a very short interim period makes this process impractical except for products that were already lined up for certification through a Certification Body

Canada – Provides Chemicals Assessment Update to EEE Industry

During an annual joint Government/EEE Sector WG meeting held on Thursday, November 15, 2018, Environment and Climate Change Canada provided an update on chemical assessments and regulatory developments.  The update includes:

  • A general update on the Chemical Management Plan (CMP)
  • Chemicals Management Plan: post 2020
  • Update on Flame Retardants
  • Phthalates
  • Update on Mercury Regulations
  • Mercury Lamps: National Strategy
  • Basel Technical Guidelines for E-Waste
  • Zero Plastic Waste Strategy
  • Cyanides, and
  • Formaldehyde

Most of presentations were updates on the strategies and risk assessment activities currently underway.

In October, Environment Canada published a Notice of Intent (NOI) to amend The Prohibition of Certain Toxic Substances Regulations, 2012 (PCTSR) to further restrict five groups of substances: HBCD, PBDEs, PFOS, PFOA, LC-PFCA and to potentially prohibit DP and DBDPE (pending the outcome of a final screening assessment).

On the topic of phthalate substances, Environment Canada indicated that the risk assessment is expected in mid-2019 and they are not able to provide at this time any insight on whether restrictions might be implemented.

Environment Canada is implementing changes to the Mercury restrictions to align with the Minimata convention and restrictions in other jurisdictions. The consultation document on the changes was published last February. Environment Canada expects to publish the new regulation in 2020 with a 1-year delay in implementation.  They indicated that an exemption is planned for replacement parts.