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Four additional substances and substance groups to the EU REACH Candidate List

We occasionally distribute Information Bulletins with important regulatory or standards related information. The following information has just become available:

The European Chemical Agency (ECHA), on July 16, 2019 added four additional substances and substance groups to the EU REACH Candidate List. The new Substance of Very High Concern (SVHC) entries are listed in the table below. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – SVHCs that are possible EEE constituents are shown with their typical EEE applications.  There is now a total of 201 SVHCs on the REACH Candidate List.

The IEC 62474 DSL will be updated later this week. TNPP will be added as the only SVHC that realistically could be a constituent of EEE above the threshold.

The full REACH Candidate List is available at: http://echa.europa.eu/candidate-list-table

Substance NameDescriptionCAS no.EC no.Examples of use(s) (ECHA)Typical EEE Applications
2-methoxyethyl acetate110-49-6203-772-9Not registered under REACH.n/a
Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP)--Primarily used as an antioxidant to stabilise polymers.stabilizer and antioxidant in the processing of various plastic materials such as PVC, Polyolefines or rubbers
2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halidescovering any of their individual isomers and combinations thereof--Processing aid in the production of fluorinated polymers.n/a
4-tert-butylphenol98-54-4202-679-0Used in coating products, polymers, adhesives, sealants and for the synthesis of other substances.n/a

Sweden – Increases Tax on Electronics with Flame Retardants

The Swedish tax law (Act 2016:1067) on electronics containing flame retardants was revised by the Swedish Ministry of Finance to increase tax rates and update the products included within the scope of the law.  The law requires that a tax be paid on certain EEE products when they are placed on the market in Sweden; however, a tax reduction is available if the products can be shown to not contain bromine, chlorine or phosphorus.  Swedish Law 2019:489 amending the Tax on Chemicals in Certain Electronics Law 2016:1067 was published on June 26, 2019.

The law uses the Combined Nomenclature (CN) customs codes to determine which products are in scope.  Section 3 of the law, which sets out the products that must pay the tax, is updated and includes the CN codes shown in Table 1.

Table 1: Products included in scope of Swedish Tax Law (Act 2019:489)

Product CategoryCN Codes and Products
18418 10 (Combined refrigerator-freezers, fitted with separate external door), 8418 21 (compression type household refrigerators), 8418 29 (other refrigerators), 8418 30 (chest type freezers not exceeding 800 litres) and 8418 40 (upright type freezers not exceeding 900 litres)
28422 11 (household dishwashers)
38450 11 (fully automatic household or laundry washing machines including machines which both wash and dry of a dry linen capacity not exceeding 6kg), 8450 12 (other fully automatic household or laundry washing machines including machines which both wash and dry with built in centrifugal drier) and 8450 19 (other fully automatic household or laundry washing machines including machines which both wash and dry),
48451 21 (machines for washing, cleaning, drying, ironing etc textile yarns, fabrics, or other support used in the manufacture of floor coverings of a dry linen capacity not exceeding 10kg)
58471 30 (Portable automatic data-processing machines weighing not more than 10kg), 8471 41 (data-processing machines comprising in the same housing at least a central processing unit and an input and output unit) and 8471 49 (other portable automatic data-processing machines)
68508 11 (vacuum cleaners with self contained electric motors of a power not exceeding 1500 W and having a dust bag or other receptacle capacity not exceeding 20 L)
78516 50 (electric instantaneous or storage water heaters and immersion heaters and 8516 60 (other ovens, cookers, cooking plates, boiling rings, grillers and roasters),
88517 11 ( line telephone sets with cordless handsets), 8517 12 (Telephones for cellular networks or for other wireless networks), 8517 18 (Other apparatus for the transmission or reception of voice, images or other data, including apparatus for communication in wired or wireless network) and 8517 62 (machines for the reception, conversion, and transmission or regeneration of voice images or other data including switching and routing apparatus)
98519 30 (turntables / record decks), 8519 50 (telephone answering machines), 8519 81 (sound reproducing apparatus including cassette players not incorporating a sound recording device) and 8519 89 (other magnetic, optical or semi conductor media)
108521 10 (magnetic tape type video recording or reproducing apparatus) and 8521 90 (other video recording or reproducing apparatus),
118527 12 (pocket size radio cassette players), 8527 13 (other apparatus combined with sound recording or reproducing apparatus), 8527 19 (radio broadcast receivers not capable of operating without an external source of power used in motor vehicles) , 8527 91 (other combined sound recording or reproducing apparatus housing one or more loudspeakers), 8527 92 (clock combined sound recording or reproducing apparatus) and 8527 99 (printed circuit board sub assemblies)
128528 41 (Cathode-ray tube monitors of a kind solely/principally used in an automatic data processing system of heading 84.71), 8528 49 (other monitors), 8528 51 (other monitors), 8528 59 (projectors), 8528 71 (reception apparatus for television not designed to incorporate a video display or screen) , 8528 72 (other colour) and 8528 73 (other monochrome), and
139504 50 (video game consoles and machines).

For a taxable good referred to in categories 1–4, 6 or 7 of Table 1, the tax payable is increased from SEK 8 to SEK 11 per kilogram of the net weight of the taxable good (not exceeding SEK 440  per taxable good).

For a taxable good referred to in categories 5 or 8–13 of Table 1, the tax payable is increased from SEK 120 to SEK 160 per kilogram of the net weight of the taxable good (as above, up to a maximum tax of SEK 440 per taxable good).

An official list of taxable goods, along with their corresponding CN codes, can be found on the Swedish Tax Agency website[1]. The amendment enters into force on 1 August 2019.

[1] Swedish Act, https://www.svenskforfattningssamling.se/sites/default/files/sfs/2019-06/SFS2019-489.pdf

EU – RoHS Phthalate Restrictions take Effect Starting July 22, 2019

EEE Manufacturers are reminded that the phthalate restrictions for DEHP, DBP, BBP, and DIBP are in effect for any EEE products in RoHS categories 1-7, 10, and 11 that are placed on the market starting July 22, 2019.

Name of SubstanceCas No.
Bis(2-ethylhexyl) phthalate (DEHP)117-81-7
Dibutyl phthalate (DBP)84-74-2
Benzyl butyl phthalate (BBP)85-68-7
Diisobutyl phthalate (DIBP)84-69-5

The new EU RoHS requirements are applicable based on when individual product units are “placed on the market”.

Impact on EEE Manufacturers

Organizations that meet the definition of ‘Manufacturer’ under the EU RoHS Directive and have products that are in scope of the new phthalate restrictions should confirm that they are meeting all obligations listed under the EU ROHS Directive Article 7 (Obligations of manufacturers).  This includes updating the technical documentation to demonstrate that the four phthalate substances are not in the product above the 0.1 mass% of homogeneous material threshold.

Repair and return systems may also need to be updated to ensure that any RMA units shipped to customers in the EU either (1) meet the new substance restrictions, or (2) were previously been placed on the EU market before the new restrictions came into effect.

ECD Compliance can provide assistance with compliance to the new phthalate restrictions.

Ontario – Expands WEEE Regulation to Cover all EEE

Ontario has proposed a new WEEE regulation that would make producers responsible for end of life collection and recycling.  This would replace the current Ontario WEEE regulation that requires consumers to pay an eco fee at the time of purchasing a product.  If adopted the Ontario regulation will be one of the most comprehensive WEEE regulations among all states and provinces in North America.

The definition of EEE is similar to that of EU WEEE and RoHS, applying to products that are “designed for use with an electric current and a voltage rating not exceeding 1000 volts for alternating current and 1500 volts for direct current”.  For purposes of WEEE responsibilities, EEE products are grouped into four categories:

    1. Information technology, telecommunications and audio visual equipment.
    2. Large equipment.
    3. Lighting.
    4. Small equipment.

Responsibilities of the producer include a free collection network for end of life products, achieving resource recovery targets, promotion and education to increase consumer awareness, and to register, report and keep records.

The proposed regulation specifies requirements that would significantly increase the number of collection sites.

Details on collection requirements are provided in the proposed regulation[1].

[1] Proposed Ontario WEEE regulation, https://ero.ontario.ca/notice/019-0048

China – Conformity Assessment System for China RoHS

China has clarified the requirements for demonstrating conformity to China RoHS 2 substance restrictions.  The restrictions came into effect on March 15, 2019 and the new conformity requirements will be enforced as of November 1, 2019.

Background

In March 2018, the China Ministry of Industry and Information Technology (MIIT) published the “1st Compliance Management Catalogue of Electric Appliances and Electronic Products for Restriction Use Hazardous Substances” and “Applications Exempted from the Restriction in Product Compliance Management Catalogue” for China RoHS 2. The substance restrictions were specified as coming into effect on March 15, 2019. However, the compliance requirements were noticeably missing, creating confusion about what manufacturers needed to do by March 2019.

Conformity Assessment System going Forward

The Chinese State Administration for Market Regulation published the Implementation Measures on a Conformity Assessment System for the Restricted Use of Hazardous Substances in Electrical and Electronic Products on 16 May 2019:

Electrical and electronic products which are listed in the RoHS 2 Catalogue and manufactured or imported after 1 November 2019 must comply with the new conformity assessment requirements. This includes:

    • refrigerators
    • air conditioners
    • washing machines
    • electric water heaters
    • printers
    • copiers
    • fax machines
    • televisions
    • monitors
    • microcomputers
    • mobile communication devices
    • telephones

Companies may choose one of two methods to complete the conformity assessment:

    • Voluntary Certification for Restricted Use of Hazardous Substance in Electrical and Electronic
    • Company Self-declaration

A compliance label is attached to the product based on which conformity method is used. Information related to conformity assessment will be published by the manufacturer on the information platform set up by MIIT and the State Administration of Market Regulation

Additional Information on the Self-Declaration Approach

The procedure and requirements for self declaration are specified in Annex 2 of the Notice. They leverage the China Standard GB/T 36560 2018 (China national adoption of IEC 63000 on technical documentation with respect to the restriction of hazardous substances). Manufacturers or their authorized representative must also submit a supplier declaration of conformity (SDoC).

Overall, the China RoHS self declaration is similar to the EU RoHS conformity requirements (i.e. EU DoC, CE Mark, and technical documentation file). However, unlike EU RoHS, the SDoC and technical documentation file must be uploaded into a repository (referred to as the “public service platform”) within 30 days of placing the product on the China market.

Enforcement

The Notice (section 5.3) states that non-conformity of products will be made public.

Further Information

The conformity assessment Notice was jointly published by the China SAMR (State Administration of Market Regulations of P. R.C.) and MIIT (Ministry of Industry &Information Technology) as SAMR MIIT Notice No.23 2019.

 

 

 

 

 

 

CEN – New Technical Committee for Regulated Chemicals in Products

The European CEN standards organization (EU version of ISO) has approved a new Technical Committee (TC462) on regulated chemicals in products.

Title: CEN/TC 462 ‘Regulated Chemicals in Products’

TC 462 was approved in March 2019. However, there concerns about conflicts with other International standards that are in use or under development.  The French National Body (AFNOR) will be the secretariat of the new TC.

EU – ECHA Database Proposal for SVHCs in Articles

The European Chemical Agency (ECHA) developed an updated specification on the upcoming SVHC in articles reporting database and circulated to a very limited set of stakeholders.  The document, titled “Detailed information requirements for the database on articles containing Candidate List substances under the Waste Framework Directive” is the next step in ECHA developing the database.   A very short 2 weeks were provided for comments in May 2019.

ECHA has retained most of the data fields that were in their original proposal, but many are now proposed as optional instead of mandatory. Industry pushed back on the original proposal arguing that the extensive data reporting was (1) not supported by requirements in the REACH regulation and the Waste Framework Directive (WFD) and (2) impractical to obtain for complex products with multi-level BOMs.  ECHA responded that the requirements specified in the regulations justify the data fields but have never-the-less acquiesced by making many of the fields optional.

However, the requirement to report the first articles containing SVHCs is retained in the proposal.  Furthermore, the database will require the manufacturers to report the “article category name and code” – the ‘code’ is described as being the Combined Nomenclature (CN) code that is used for customs purposes.  CN codes are based on the International Harmonized System (HS) and tend to be a bit of a mystery to everyone except import/export experts. Most manufacturers know the CN code for their products but may not know the CN/HS codes for articles buried deep in the BOM of a complex product.

To demonstrate the requirement, ECHA provides an example database submission for an imported car.  The example involves reporting a car as a complex object; that contains an engine as a complex object; and an O-ring containing an SVHC that is an article within the engine. In the example, the O-ring is identified with article code “4008 21 90: [4008: Plates, sheets, strip, rods and profile shapes, of vulcanised rubber other than hard rubber; – Of non-cellular rubber;] — Other”

Impact on EEE Manufacturers

Between the combination of (1) the European Court of Justice ruling that SVHC concentration is based on when it is first applied to an article and (2) the metal lead was added to the Candidate List, most complex EEE products are likely to contain at least one SVHC above the 0.1% threshold and possibly several SVHCs.  Therefore, the reporting requirements for the database, especially information about first articles containing an SVHC will be challenging for many EEE manufacturers. The information goes beyond the what OEMs typically collect from their suppliers.

ECD Compliance can assist manufacturers and solution providers to stay up to date on emerging developments on the database and to prepare supply chain management operations and IT systems for the SVHC in article reporting requirements.

EU – Ecodesign for Servers Published

The European Implementing Measure for compute servers and data storage products was published in the EU Official Journal[1] as COMMISSION REGULATION (EU) 2019/424 on March 18, 2019.  The scope, requirements and implementation dates are the same as indicated in our November 2018 ECD report.

The new regulation imposes requirements on:

  • PSU efficiency,
  • idle state power,
  • active state efficiency based on the SEEM/SERT 2 metric,
  • repair and reuse requirements (referred to as material efficiency),
  • information provided to end-users,

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.