EU – Proposed Restriction of Microplastics, Formaldehyde and D4, D5 and D6

ECHA has submitted proposals to restrict:

  • microplastics (EC -, CAS -);
  • formaldehyde and formaldehyde releasers (EC -, CAS -); and
  • octamethylcyclotetrasiloxane (D4) (EC 209-136-7, CAS 556-67-2), decamethylcyclopentasiloxane (D5) (EC 208-764-9, CAS 541-02-6) and dodecamethylcyclohexasiloxane (D6) (EC 208-762-8, CAS 540-97-6).

The proposed siloxane restriction (D4, D5, and D6) has raised concerns from European industry groups.  D4, D5, and D6 are used in the production of silicone polymer sealants and may therefore be present as impurities.  They argue that the restriction will have “unintended consequences” for the environment given that “the use of silicone polymers reduces the carbon footprint of countless other sectors.”  They describe the use of the siloxanes as an important area for innovation of silicone polymers.

ECHA is accepting comments on the proposal until 20 September 2019.

 Impact on EEE Manufacturers

Given that silicone polymers are commonly used in the manufacturing of EEE, the potential presence of D4, D5, and D6 should be reviewed by EEE manufacturers.

Note: Some manufacturers may use silicone polymers as a shop floor material and therefore it may not necessarily show up on the product’s bill of materials.

EU – Nordic Enforcement Finds Phthalates and SCCPs

The EU Nordic countries of Sweden, Denmark, Finland, Iceland, and Norway recently completed a joint enforcement project on give-away products such as pens, electronic products, toys, bags, and other gadgets.  These items are typically imprinted with a company name/logo for advertising.  The Norwegian Environment Agency has produced a brief summary of the results[1].

The enforcement program involved 250 products from over 100 companies. The Chemical agencies were looking for regulated substances in the product and for non-compliant marketing (e.g. CE marking).

Of the EE products, 12% were non-compliance due to presence of restricted chemicals and 25% were non-compliant due to missing CE marking.

[1] Nordic Enforcement Summary, https://mst.dk/media/172187/2019_02_18-nordic-enforcement-of-give-away-products-press-release.pdf

CEN/CENELEC – Update on Material Efficiency and CRM Standards

Two European CEN/CENELEC standards being develop as part of the European Commission mandate (M/543) to enable the circular economy were published on March 1, 2019. The two standards being developed in WG6:

  • EN 45558:2019 ‘General method to declare the use of critical raw materials in energy-related products’
  • EN 45559:2019 ‘Methods for providing information relating to material efficiency aspects of energy-related products’

A CEN/CENELEC news brief[2] provides the following description of the standards:

EN 45558:2019 distinguishes between regulated and non-regulated CRMs and assist users (manufacturers and their suppliers) to make CRM declarations, giving the supply chain some level of certainty regarding what to report, how to report and a standardized mechanism to communicate the data throughout the supply chain. To achieve this, EN 45558 builds upon EN IEC 62474 standard on material declaration.

EN 45559 establishes a general method, including rules and formats, for the provision of information related to the material efficiency aspects of energy-related products.

Several other circular economy standards are still under development.

CRM Communication and Regulations

The European CRM list includes 27 entries as of March 2019. The European Commission plans to impose regulatory requirements for specific CRMs on specific products; these may be included in ecodesign implementing measures.

The EN 45558:2019 standard on CRMs differentiates between regulated CRMs and non-regulated CRMS.  For regulated CRMs the standard requires users to provide the CRM information in the IEC 62474 material declaration format. The CRM standard recommends that IEC 62474 is also used when non-regulated CRMs are reported.  To accommodate CRM reporting, the IEC 62474:2018 is being updated by an Amendment 1 to clarify the use of alternate DSLs such as CRM lists.

When manufacturers of EEE products are required to report CRMs in the EU (such as in the  upcoming ecodesign IMs), the CRMs may be added to the IEC 62474 DSL.

Impact on EEE Manufacturers

The specific CRM requirements will depend on the product type.  Manufacturers should track EU regulations – especially ecodesign implementing measures – that could impose CRM reporting obligations on their products. Once a CRM reporting is identified, manufacturers will need to start requesting the information from suppliers – there will typically be at least a one-year transition period after the regulation is published.  Once the CRM is added to the IEC 62474 DSL, this DSL may be used to request information.

[2] CEN/CENELEC news brief, https://www.cencenelec.eu/News/Brief_News/Pages/TN-2019-017.aspx

EU – China Comments on EPS Ecodesign Requirements

China has submitted comments in response to the EU’s WTO TBT posting of new ecodesign requirements for external power supplies (EPS) (November 2018 ECD Report). The Chinese comments request:

  • To delete the requirement to provide information on 10% load efficiency
    • China’s argument is that other countries such as US, Canada, Australia do not require testing at 10% load
    • If the 10% load requirement is not deleted, China recommends exempting EPS with output power level ≤10W
  • Clarification of the exclusion for spare parts for products that are place on the market by 1 April 2021. Given that the requirements come into effect in 2020 the allowance for products placed on the market before 2021 is unclear.
  • Clarification of the meaning of “household and office equipment”
    • The definition in the proposed regulation is vague compared the definition in the existing EPS regulation.
    • China suggests clarifying that this refers to EMC class B products as set out in EN 55022:2006
  • Extend the transition period until 1 April 2021 instead of 1 April 2020. China feels that a one-year transition period is too short
  • Exclusion of two types of EPS:
    • Power frequency transformer
    • EPS with power line communication (PLC) function
  • To revise the test procedure for multiple output EPS
    • EN 50563 does not include multiple voltage output power supplies within its scope
  • That the regulation should specify power consumption using only two decimal places (as specified in IEC 62301-2011) instead of the current three decimal places proposed in Annex I(a). Three decimal places of accuracy will impose new requirements on test equipment and test methods for testing EPS.

Impact on EEE Manufacturers

The regulation will impact most product manufacturers that use external power supplies.  The outcome of China’s question on the definition of “household and office equipment” could have an impact on whether your EPS are in scope or not.

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/

IEC 62474 Declarable Substance List Updated on January 15, 2019 with New REACH SVHCs

The IEC 62474 Declarable Substances List was updated on January 15, 2019, the same day that ECHA updated the EU REACH Candidate List with six additional Candidate List SVHCs.  The IEC 62474 Validation Team found that that five of these six substances are potential constituents of EEE. Details of the update are provided on the IEC 62474 blog posting.

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.