Category Archives: nl2020q2

EU – Consultation on Proposed Restriction of PFHxA

ECHA launched a public consultation on the restriction proposal for Perfluorohexanoic acid (PFHxA), its salts and related substances in the EU. PFHxA substances are used in the manufacture of fluoropolymers (plastics which may be used in EEE) and clothing.  They are used as manufacturing chemicals and typically would not remain in a finished product; however, the proposed threshold for PFHxA substances in polymers is very low (0.0001%) meaning that even residual amounts of the substances could be above the restriction level.

PFHxA substances are also used in semiconductor manufacturing operations. An exemption is proposed for this application.

Additional information on the proposed restriction and the consultation may be found on the ECHA website[1].

[1] PFHxA consultation website,

EU – Updates RoHS Technical Documentation Standard

The May 18, 2020, the EU officially updated the reference standard for EU RoHS technical documentation to IEC EN 63000 from the previous standard EN 50581. The change was published in EU Decision (EU) 2020/659. EN 50581 remains valid until November 18, 2021.

Impact on EEE Manufacturers

The transition to IEC 63000 has been planned for the past couple years and should not have a material impact on conformity assessment– both IEC 63000 and EN 50581 specify very similar requirements.

Manufacturers with products that are in scope of EU RoHS should start to update their EU Declarations of Conformity to reference IEC EN 63000 (or IEC 63000) instead of EN 50581.  An 18-month transition period is provided to make the changes.

Germany – Study Indicates High Use of DPHP Phthalate

A study by the German Environmental Agency (UBA) has found that the phthalate DPHP has become the primary substitute for DEHP.  DEHP has been a REACH Candidate List SVHC since 2008 and was restricted by the EU RoHS Directive in EEE starting in 2019.  It was commonly used as a plasticizer in wire sheathing and other soft plastic parts.  The study, which conducted testing of phthalate levels in the environment between 2006 and 2017 found that the level of DEHP went from a mean of 2,710 nanograms per gram of dry weight (ng/g dw) to 991ng/g dw. Whereas DPHP has increased from 57ng/g dw to 550ng/g dw over the same time period.

The increased use of DPHP has gained it additional attention with regulators; the phthalate is undergoing evaluation this year to consider:

  • potential endocrine disruption;
  • exposure of sensitive populations;
  • high aggregated tonnage; and
  • wide dispersive use.

Impact on EEE Manufacturers

There is a possibility that DPHP may exhibit properties that makes it eligible as a candidate to become a REACH SVHC.  Manufacturers should try to collect and maintain information on phthalates that are used in the product parts they procure.

EU – Two of Seven Substances Selected for EU RoHS

The European Commission has focused their attention on two of the seven substances that are under consideration for EU RoHS restriction.  The two substances being recommended for the RoHS Annex II list of restricted substances are: TBBPA and MCCPs (Table 1).

Table 1: Substances recommended for EU RoHS restrictions

Substance(s)SynonymsCAS Number
Tetrabromobisphenol A
Medium- chained chlorinated paraffins –Alkanes, C14-17, chloro
(chlorinated paraffins containing paraffins with a chain length of C14-17 – linear or branched)

The consultants presented the results of their evaluation during a stakeholder webinar on April 27, 2020. A summary of some key information is provided below and links to presentation materials are provided at the end of this article.

Tetrabromobisphenol A  (TBBP-A)

The consultants indicated that the primary uses for TBBP-A in EEE include:

  • Precursor in the production of brominated epoxy resins that function as reactively flame-retarded substrate in printed wiring boards (PWB), ~90%
  • additive flame retardant in thermoplastic EEE components, for example housings that consist of ABS plastic, ~ 10%

The general conclusion was that TBBP-A used as a resin in the production of printed circuit boards would be mostly consumed in the manufacturing process with residual TBBP-A remaining in the product generally below the 0.1% of homogeneous material threshold.

The focus of a restriction would be on TBBP-A as an additive flame retardant that remains in thermoplastic materials.

TBBP-A is also being assessed under the EU REACH regulation as a possible SVHC. The consultants are recommending that the results of the SVHC assessment be considered in any final RoHS restrictions

Medium-chain chlorinated parafins (MCCP)

The consultants presented the following MCCP uses and amounts:

  • The main function of MCCPs is that of a secondary plasticiser (extender) in PVC -> it lowers the use of more expensive primary plasticisers.
  • Moreover, MCCPs provide flame retardant properties and are added to PVC, rubber and other polymers.
  • Noteworthy that MCCPs represent a substitute for short-chain chlorinated paraffins (SCCPs)
  • The main EEE application area of MCCPs in the EU are PVC insulations and sheathing for electric cables and wires
  • Typical concentration of MCCP in PVC insulation is 8-15 % of weigh. Total EU consumption for cable applications estimated in the range of 1,000 to 10,000 t per year

MCCP was also recently assessed under REACH and found to meet the criteria for consideration as an SVHC.

Further Information:

Links to the presentations from the stakeholder webinar are provided at the bottom of the webpage on interim results of substance review[1].

[1] Presentation from RoHS substance review,


EU – Update on SCIP Data Submission Requirements

On March 20, 2020, ECHA briefed the SCIP IT User Group on several changes that are being developed for the SCIP submission format and data requirements. ECHA also provided updates on what they are doing to simplify the SCIP submissions, including:

  • Allowing third parties to submit data on a company’s behalf
  • Enabling a distributor to make a simplified SCIP notification referencing a submission already in SCIP (made by the manufacturer or importer) when the product is not being changed;
  • Refer to articles already notified in SCIP when they are incorporated into complex objects (useful for assemblers)

The following planned changes to the IUCLID SCIP submission format were presented by ECHA:

  • Concern element section
    • Data field for Candidate List version is being deleted (this was causing too much confusion)
    • ECHA is updating the mixture category list
  • Complex object component section
    • The number of units data field to indicate the number of identical articles will be optional (this field was creating significant complexity given that many products are configurable so the number of component articles isn’t known (e.g. memory devices in a computer)
  • Identifiers
    • New option in the primary article identifier dropdown list to reference an existing entry in the SCIP database
  • Categorisation:
    • Production EU Flag
      • Dropdown list options are being changed from “Yes, No, Unwilling to Disclose” to “EU produced, EU imported, Both EU produced and imported, No data”
    • Article category
      • The Taric code list (CN codes) is being updated to extend the ECHA list codes with “0” to make all the codes 10 digits long. This is being done to align with EU trade helpdesk.

These changes are expected for the October 2020 IUCLID release.

EU – RoHS Exemptions Published

On March 25, 2020, the European Commission published five Delegated Directives with updates to EU RoHS exemptions – two updates to Annex III and three updates to Annex IV.  The Delegated Directives are (EU) 2020/360, 2020/361 and 2020/364 to 2020/366.  The published text is available on the Europa website[1].

EU RoHS Annex III:

Taking effect April 1, 2021, in Annex III to Directive 2011/65/EU, entry 9 is replaced by the following:

9Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solutionApplies 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.
9(a)-IUp to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators (including minibars) designed to operate fully or partly with electrical heater, having an average utilised power input < 75 W at constant running conditionsApplies to categories 1-7 and 10 and expires on 5 March 2021.
9(a)-IIUp to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators:
— designed to operate fully or partly with electrical heater, having an average utilised power input ≥ 75 W at constant running conditions,
— designed to fully operate with non-electrical heater.
Applies to categories 1-7 and 10 and expires on 21 July 2021.’

As of April 1, 2021, in Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:

41Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (*1))Applies to all categories and expires on:
— 31 March 2022 for categories 1 to 7, 10 and 11;
— 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.

(*1)  Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).’

Annex IV Updates

As of April 1, 2021, in Annex IV to Directive 2011/65/EU, entry 37 is replaced by the following:

37Lead in platinized platinum electrodes used for conductivity measurements where at least one of the following conditions applies:
(a) wide-range measurements with a conductivity range covering more than 1 order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory applications for unknown concentrations;
(b) measurements of solutions where an accuracy of +/– 1 % of the sample range and where high corrosion resistance of the electrode are required for any of the following:
(i) solutions with an acidity less than pH 1;
(ii) solutions with an alkalinity more than pH13;
(iii) corrosive solutions containing halogen gas;

(c) measurements of conductivities above 100 mS/m that must be performed with portable instruments.
Expires on 31 December 2025.

As of April 1, 2021, in Annex IV to Directive 2011/65/EU, entry 41 is replaced by the following:

41Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.
Expires on 31 March 2022.’

As of September 1, 2020, in Annex IV to Directive 2011/65/EU, the following entry 44 is added:

44Cadmium in radiation tolerant video camera tubes designed for cameras with a centre resolution greater than 450 TV lines which are used in environments with ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy.
Applies to category 9. Expires on 31 March 2027.’


[1] EU Delegated Directives on EU RoHS,

EU – Publishes Circular Economy Action Plan

The European Commission recently published a report on the completion of it’s 2015 Circular Economy Action Plan. Then on March 11, 2020, it published “A new Circular Economy Action Plan” that covers the years 2020-2024. This new plan puts significant emphasis on the electronics industry and will undoubtedly lead to new regulations that impose sustainability requirements on electronic products.

Key objectives of the action plan are:

  • Economic growth that is decoupled from the use of resources
  • Climate neutrality by 2050
  • Sustainable products as the norm
  • Linking industry strategy to circular business models
  • Leadership to a global circular economy

The main initiatives that will impact EEE manufacturers are:

  • Circular Electronics Initiative,
  • Sustainable Product Policy Initiative and the
  • Chemicals Strategy for Sustainability.

The Commission will be developing regulatory and non-regulatory instructions to implement these initiatives in the 2020-2024 timeframe.

IEC 62474 – Material Declaration Format for SCIP is Published

The IEC 62474 data exchange format (XML schema and Developer Table (DT)) update to support EU SCIP database fields was published on March 15, 2020. This is a minor update that provides additional optional data fields to support supply chain communication of select information needed for the EU SCIP database. The new version is X8.10. It’s backward compatible with X8.00. SCIP information from suppliers is supported by both the Composition Declaration module and the Declaration for Compliance Module.

The IEC 62474 declaration format is available from the IEC 62474 database[1].

[1] IEC 62474 database,

IPC-1754 – Amendment 2 is Approved at Ballot

IPC-1754 Materials and Substances Declaration for Aerospace and Defense and Other Industries, Amendment 2 was approved March 2020 and is expected to be published in May 2020.

IPC-1754 supports several material declaration features needed by Aerospace and several other industries that go beyond the IPC-1752 and IEC 62474 standards, including declaring manufacturing processes and process chemicals.

Amendment 2 to the standard add:

  • Additional data fields to support supplier declaration of information needed for the EU SCIP database
  • Declaration of substance groups when specific substances are not known
  • Declaration of exemptions (such as EU RoHS exemptions) to allow declaration data to be more readily exchanged with IPC-1752 and IEC 62474

When published, IPC-1754 AM2 will be available on the IPC webstore[1].

[1] IPC online store,


ISO TC323 – Proposals for Circular Economy Standards

In 2019, a new ISO technical committee (TC323) was launched to provide standardization in the field of Circular Economy (CE). The standardization documents are to include: “frameworks, guidance, supporting tools and requirements for the implementation of activities of all involved organizations, to maximize the contribution to Sustainable Development”.  There is some concern about the creation of the TC given that standardization work on CE is already underway in IEC/TC111 and ISO/TC207 (Environmental Management Systems).

Never-the-less, the TC received sufficient support from National Bodies around the world and was officially launched in 2019.  Three New Work Item Proposals to begin the standardization work were recently circulated for voting.  The proposals are on:

  • ISO 99004 Circular Economy – Framework, principles, terminology, and management system standard
  • ISO 99010 Circular economy — Guidelines on business models and value chains
    • The circular business models are to be based on:
      • circular design (lifetime extension, dematerialization, refurbish and maintain);
      • circular use (sell and buy-back, circular supplies, product as a service, sharing/lease)
      • circular recovery (recapture material, recycling facility, recovery provider)
    • ISO 99020: Circular economy — Measuring circularity framework

A study on “Circular economy – Performance-based approach – analysis of cases studies” has also been proposed.

Information about ISO/TC323 is available on the ISO website[1].


Impact on EEE Manufacturers

Many EEE manufacturers have already implemented select CE initiatives; however, there’s concern that some CE actions that may improve circularity could have negative side-effects to compromise safety or reduce innovation.  This is especially true in the EEE industry.  Potential trade-offs should be taken into account in the development of these CE standards.

[1] ISO/TC323 website,