Author Archives: ECD_admin

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, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:067:TOC

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, http://std.iec.ch/iec62474/iec62474.nsf/index

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, https://shop.ipc.org/

 

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, https://www.iso.org/committee/7203984.html

 

EU REACH Authorization List Updated with Eleven SVHCs

The European Commission has updated the REACH Annex XIV Authorization List with eleven additional SVHC entries.  The manufacturing and use of these substances in Europe are banned after the sunset date unless the manufacturer has an authorization from the European Chemical Agency (ECHA). All of these newly added substances are already on the REACH Candidate List.

Note: the authorization list does not impact articles that are imported into the EU if the substance was manufactured or used outside of Europe.

The authorization list now includes a total of 54 entries; the full list is available on the ECHA website at https://echa.europa.eu/authorisation-list

Table 1: Substances added to REACH Annex XIV Authorisation List

Entry No. Substance name EC No.CAS No.Latest application dateSunset DateTypical EEE Applications (from IEC 62474)
441,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear271-093-568515-50-427/08/202127/02/2023Used as a plasticizer for certain plastics and rubbers
45Dihexyl phthalate201-559-584-75-327/08/202127/02/2023Plasticizer, dye, pigment, paint, ink, adhesive, lubricant
461,2-benzenedicarboxylic acid, di-C6-10-alkyl esters or mixed decyl and hexyl and octyl diesters

with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5)

1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters EC No.: 272-013-1 | CAS No.: 68648-93-1

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters EC No.: 271-094-0 | CAS No.: 68515-51-5
--27/08/202127/02/2023Plasticisers, lubricants, adhesives, coatings, cable compounding, polymer foils, PVC compound coatings, paints, thinners, paint removers, fillers, putties, plasters, ink and toners, greases, release products, polymer preparations and compounds, and semiconductors
47Trixylyl phosphate246-677-825155-23-127/11/202127/05/2023Used as a plasticizer for vinyl resin, cellulose resin, natural and synthetic rubber. Also, used as a flame retardant.
48Sodium perborate, perboric acid, sodium salt

Sodium perborate EC No.: 239-172-9 | CAS No.: 15120-21-5

Perboric acid, sodium salt EC No.: 234-390-0 | CAS No.: 11138-47-9
--27/11/202127/05/2023n/a
49Sodium peroxometaborate231-556-4April 4, 763227/11/202127/05/2023n/a
505-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 stereoisomers of [1] and [2] or any combination thereof

1,3-Dioxane, 2-(2,4-dimethyl-3-cyclohexene-1-yl)-5-methyl-5-(1-methylpropyl)- EC No.: 413-720-9 | CAS No.: 117933-89-8
2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane EC No.: 601-499-3 | CAS No.: 117933-89-8
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 stereoisomers of [1] and [2] or any combination thereof] EC No.: 700-927-7 | CAS No.: -
5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane EC No.: - | CAS No.: -
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane EC No.: - | CAS No.: -
--27/02/202227/08/2023n/a
512-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol247-384-825973-55-127/05/202227/11/2023UV stabilizer
522,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol223-383-83864-99-127/05/202227/11/2023UV stabilizer
532-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol253-037-136437-37-327/05/202227/11/2023UV stabilizer
542-benzotriazol-2-yl-4,6-di-tert-butylphenol223-346-63846-71-727/05/202227/11/2023UV-stabilizer in adhesives, paints, printing inks, plastics, inked ribbons, putty, caulking or sealing fillers

EU – Proposed Restriction of Undecafluorohexanoic acid (PFHxA)

Germany has submitted a proposal to restrict Undecafluorohexanoic acid (PFHxA), its salts and related substances in the EU.  The proposed restriction includes substances in article based at concentration limits of

  • the sum of PFHxA and its salts at a concentration equal to or above 25 ppb and
  • the sum of PFHxA- related substances equal to or above 1000ppb.

Undecafluorohexanoic acid (PFHxA), its salts and related substances are defined in the proposal as:

(a) Any PFHxA-related substance (including its salts and polymers) having a linear or branched perfluoropenty group with the formula C5F11- directly attached to another carbon atom;

Eurasia – RoHS Takes Effect Starting March 1, 2020

Eurasian RoHS takes effect starting March 1, 2020. The substance restrictions and conformity requirements will be in effect across the Eurasian Economic Union (EAEU) which includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. The substance restrictions and thresholds are the same six substances that were initially restricted in EU RoHS.  The main difference with Eurasian RoHS is the submission of certification and/or declaration documentation.

The Eurasian RoHS technical regulation was published as TR EAEU 037/2016 on restricting the use of hazardous substances in electrical engineering and radio electronic products. It applies to a broad range of EEE products. In October 2018, a specific list of products (with custom codes) was published as EAEC Decision No. 167 to supplement the original regulation. Continue reading

EU – REACH Article 33 Enforcement Project Report

In a November 18, 2019 press release, ECHA announced the results and publication of the official report on a REACH Article 33 Enforcement Project involving 15 EU countries. The project tested 682 articles from 405 companies; products included: “clothing, footwear and home textiles; wires, cables and electronic accessories; plastic or textile floorings; wall coverings; and other plastic and rubber products

Of the articles tested, 12% (84 of 682) were found to contain at least one Candidate List Substance above 0.1%.

    • For 45 of those, there was a duty to communicate SVHC information down the supply chain (b2b) as per REACH Article 33; however, the communication requirement was met for only 5 of the articles resulting in an 89% non-compliance.
    • For companies supplying articles directly to consumers (b2c), 22 of 43 suppliers were considered as not providing enough information about the SVHCs to ensure safe use.

The overall verdict made by ECHA in the report is that the level of REACH SVHC in articles disclosure is not acceptable and steps need to be taken to improve the situation.

ECHA pointed to the upcoming SCIP database as one tool that should help start to drive improvements in SVHC disclosure.

The ECHA press release and report are available on the ECHA website[1].

[1] ECHA press release, https://echa.europa.eu/-/companies-need-to-improve-communication-of-hazardous-substances-in-products