Author Archives: ECDadmin2

EU – ECHA Proposes Lead for REACH Annex XIV Authorization List

During the ECHA EU Member State Committee meeting in December 2021[1], ECHA discussed its recommendation for additions to the REACH Annex XIV Authorization List.  ECHA has proposed 8 substances for this draft 11th Annex XIV recommendation.  The substances include:

  • Ethylenediamine;
  • 2-(4-tert-butylbenzyl) propionaldehyde;
  • Lead;
  • Glutaral;
  • 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one;
  • 2-benzyl-2-dimethylamino-4′-morpholinobutyrophenone;
  • Diisohexyl phthalate and
  • Orthoboric acid, sodium salt

Particularly notable is the proposal to add ‘Lead’ metal to Annex XIV.

The next step in finalizing the Annex XIV recommendation is for ECHA to conduct a 3-month stakeholder consultation on the draft list.

[1] ECHA 11th recommendation for Annex XIV, https://echa.europa.eu/documents/10162/2200440/minutes_msc-76_en.pdf/2dade9fe-fe5a-68f3-764e-bee6ab9c7195?t=1639746667638

EU – Ecodesign Requirements for Off, Standby and Networked Standby Modes

The European Commission has proposed an ecodesign implementing measure that will impose requirements to implement low-power modes in many types of household and office equipment products that are not already covered by existing low-power mode regulations.  Products will need to provide specific low-power features and meet a maximum power consumption when products are in a low-power mode.

The list of products includes:

  • Many types of household and kitchen appliances;
  • Information technology equipment intended primarily for use in the domestic environment, but not including computers and electronic displays that are already covered by their own ecodesign regulations;
  • Consumer equipment, include audio/video recording, playing and streaming equipment;
  • Toys, leisure, and sports equipment;
  • Adjustable furniture; and
  • Motor-operated building elements (shutters, blinds, door, gates, etc.)

The ecodesign requirements are specified in Annex II of the regulation. They include:

  • Energy efficiency requirements for off mode, standby mode, and networked standby mode (as applicable)
  • Functional Requirements for power management, and
  • Information requirements

Annex III to the proposed regulation specifies measurement methods and calculations.

Annex IV describes the verification procedure for market surveillance purposes.

The proposed regulation is posted on the europa website[1] for public consultation until February 23, 2022.

[1] Proposed EU ecodesign regulation, https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1558-Review-of-ecodesign-requirements-for-standby-and-off-mode-electric-power-consumption_en

EU –SCIP Statistics and Update on Future Releases

In late January, the European Chemical Agency (ECHA) posted[1] statistics on notifications submitted into the EU SCIP database since it became operational. This essentially covers the first year since the legal obligation for manufacturers, importers, and distributors to notify products with REACH Candidate List SVHCs took effect on January 6, 2021.

A few notable statistics that they mention are:

  • Seven million searchable articles in the database
    • Note: Given that one submission may represent a family of similar products (using product grouping), the number of searchable articles could represent many times that number in total products in the database.
  • Over 7,000 companies have successfully submitted notifications of products with SVHCs.
  • Of the total number of submissions, 77% were submitted using the system-to-system service, 22% using IUCLID application, and 1% using the IUCLID cloud services.

In a separate bulletin to members of the SCIP IT User Group, ECHA described their plan for the next couple years.  The next major release to the IUCLID format (including SCIP elements) has been shifted from October 2022 to April 2023.  This means that the SCIP data requirements and functionality should remain stable over the upcoming 14 months.

ECHA also highlighted a couple of submission anomalies that they are seeing.

Multiple SSN notifications using the same SCIP number

ECHA is seeing a number of occurrences when a company attempts multiple SSN (simplified SCIP notifications) submission requests using the same SCIP number.  SSN are typically made by importers and distributers using the SCIP number provided by the upstream manufacturer.  The situation described by ECHA could easy occur in the following business scenario:

  • if a SCIP number covers multiple products from the manufacturer (ECHA has recommended that manufacturers do this to improve efficiency)
  • the importer then tries to make a separate SSN for each individual product (using the same SCIP number). The first SSN will work, but the second and subsequent SSN attempts using the same SCIP number will fail.
  • EU Importers and distributers may not be aware that their SSN submissions need to exactly cover the same products that are included in the original dossier. They should not try to make individual submissions for each product.

Manufacturers who receive feedback from importers that their SCIP numbers are causing errors, should keep this in mind and ask the importer to make sure they do not submit the same SCIP number more than once.

To be proactive when providing SCIP numbers to importers, it may be helpful to clearly indicate in your communications the products that are grouped together under a common SCIP number.

Excessive SCIP updates

The second anomaly reported by ECHA are cases when rapid update submissions are made to the same article over a very short period of time (less than a minute).  This may be due to a solution provider’s software bug.

 

[1] SCIP statistics, https://echa.europa.eu/-/7-million-searchable-articles-in-scip-database-improve-transparency-on-hazardous-chemicals

EU – Candidate List Updated with Four Hazardous Chemicals

The European Chemical Agency (ECHA), on January 17, 2022, added four additional substances to the EU REACH Candidate List. The new Substance of Very High Concern (SVHC) entries are listed in Table 1. There are now 223 SVHCs on the REACH Candidate List.

Based on the requirements of the EU REACH regulation, these substances are subject to the REACH Article 33 reporting obligation as soon as they are listed. However, in practice, it typically takes manufacturers a few months to identify the substances in parts and materials and then update their declaration.

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.

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

Table 1: SVHCs added to the REACH Candidate List on January 17, 2022

Substance NameEC no.CAS no.Examples of use(s)Typical EEE Applications
tris(2-methoxyethoxy)vinylsilane213-934-01067-53-4used to manufacture rubber and plastic, to formulate non-metal surface treatment solutions or dispersions and in sealants
S-(tricyclo(5.2.1.0'2,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate401-850-9255881-94-8used to formulate lubricants (additives) and greases that are used by professional workers and at industrial sites.
6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol204-327-1119-47-1used as an antioxidant or stabiliser in the manufacture of polymers and as an additive in the rubber industry. The substance is also used by consumers and professional workers in lubricants, greases, adhesives, sealants, hydraulic fluids and metal working fluidsAdhesives, sealants, lubricants, fuels, hydraulic fluids, metal working, antioxidant/stabilizer for rubber and plastics

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

EU – General Review of RoHS Directive

The European Commission is starting to pick up the pace on its general review of the RoHS Directive.  The results from the review will be incorporated into the next major revision of the RoHS Directive (RoHS2 -> RoHS3).  The review of additional substances to be added was already concluded a couple years ago, but the Commission is also looking at fundamental changes to address practical operation of the Directive, administrative burden, and complexity of the processes. Some of the aspects being reviewed include:

  • provisions and procedures on granting/renewing/revoking exemptions to substance restrictions;
  • the process of reviewing the list of restricted substances;
  • enforcement difficulties, in particular in the context of e-commerce;
  • unclear and outdated provisions on spare parts or scope, and insufficient provisions to support the circular economy.
  • Consistency with REACH and the upcoming ecodesign regulation

In a recent call for evidence[1] (February 14 to March 14), the Commission described several options and sub-options that are being considered and may be summarized as:

  • Maintain the RoHS Directive as it stands and introduce certain non-legislative (‘soft’) measures, such as an update of the RoHS FAQ document.
  • Simplify and clarify the RoHS Directive by introducing and revising legislative (‘hard’) measures and soft measures, such as clarifying, improving, or reforming the exemption process and substance restrictions trigger process, and coherence with other legislation primarily REACH and Ecodesign.
  • Transform the RoHS Directive into a regulation.
  • Repeal the RoHS Directive and incorporate its provisions into the REACH Regulation.
  • Repeal the RoHS Directive and address product requirements under sustainable products legislation in the context of the Sustainable Products Initiative.

The Commission is asking for evidence related to these options.

Starting on March 10th, a separate public consultation[2] is being held for 12-weeks until June 2, 2022.

[1] EU RoHS call for evidence, https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13137-Review-Restriction-of-the-use-of-hazardous-substances-in-electronics_en

[2] EU RoHS public consultation, https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13137-Review-Restriction-of-the-use-of-hazardous-substances-in-electronics/public-consultation_en

EU – Mercury Exemptions Published

On February 24, 2022, the European Commission officially published twelve delegated Directives that lay out the future of the EU RoHS mercury exemptions. An overview with links to the delegated Directives is available from the Commission news release[1].

Most of the mercury exemptions are being phased out after one or one and a half years (24 February 2023 or 24 August 2023), especially fluorescent lamps for use in conventional household and commercial lighting.  High efficiency drop-in alternatives (e.g., LED lamps) are already available for most of these applications.

There are a few exemptions for special purpose lamps that are being given an additional two years until 2025. A few mercury exemptions for high-pressure or low-pressure lamps or very specialized applications are renewed for a full five years until 24 February 2027.

[1] EU mercury exemptions, https://ec.europa.eu/environment/news/commission-publishes-delegated-acts-ending-use-mercury-lamps-2022-02-24_en

France – Draft Decree on Environmental Information for Consumers

France has announced its intention to enact detailed rules for the application of Article L. 541-9-1 of the Environmental Code. The regulation requires producers and importers of certain “waste-generating products” to provide proper information to consumers about environmental quality and characteristics of the product. Several types of consumer electronics and IT products are on the list of “waste-generating products”.  A draft decree was sent by France to the European Commission to notify their intention.

Those environmental qualities and characteristics shall include, depending on the product categories concerned:

  • the incorporation of recycled material,
  • the use of renewable resources, sustainability, compostability, reparability, possibilities for re-use, recyclability,
  • the presence of hazardous substances; precious metals (gold, silver, platinum and palladium) or rare earth metals (scandium, yttrium, lanthanum, cerium, praseodymium, neodymium, promethium, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutetium), traceability and
  • the presence of plastic microfibres.

The requirement on plastic microfibres is focused on textiles but could be relevant for e-textile products.

The regulation also prohibits including on a product or package the words “biodegradable”, “environmentally friendly” or any other equivalent.

The draft decree is available from the Commission website[1].

The decree is proposed to enter into force on 1 January 2022 with compliance deadlines starting January 1, 2022 for some of the requirements.

[1] France consumer information decree, https://ec.europa.eu/growth/tools-databases/tris/index.cfm/en/search/?trisaction=search.detail&year=2021&num=644&dLang=EN

EU — Proposed Regulation for Common Charger

The European Union published its proposal for a common charger for certain consumer electronic devices: hand-held mobile phones, tablets, digital cameras, headphones, headsets, handheld videogame consoles and portable speakers.

The directive will be incorporated into the Radio Equipment Directive, but the intention is to eliminate the need for each device to be sold with its own charger, thereby reducing material use and e-waste and helping to enable the circular economy.

The proposed regulation will require these products to:

  • Use a harmonised USB-C charging port.
  • Meet specified requirements for labelling,
  • Unbundling the sale of devices and chargers,
  • Support a harmonised fast charging technology.

The proposed regulation leverages:

  • The connector and cable requirements specified in IEC 62680-1-3:2021 ‘Universal serial bus interfaces for data and power – Part 1-3: Common components – USB Type-CTM Cable and Connector Specification’
  • Incorporates the USB power delivery as specified in EN IEC 62680-1-2:2021 ‘Universal serial bus interfaces for data and power – Part 1-2: Common components – USB Power Delivery specification’

A press release on the Commission website provides a summary of the proposed directive and links to the proposal[1].

The Commission has proposed a 24-month transition period after the directive is adopted.

[1] Proposed Directive for a common charger, https://ec.europa.eu/commission/presscorner/detail/en/IP_21_4613

France – Publishes Decree on SVHC in Waste-Generating Products

On October 4, 2021, France published Decree No. 2021-1285 on Identification of Substances of Very High Concern (SVHC) in Waste-generating Products. The decree is another implementing regulation associated with the French Anti-Waste Promotion of Circular Economy, Law 2020-105.

The decree specifies which hazardous substances in products placed on the French market that need to be notified to purchasers and to an online database (e,g, SCIP).  The decree specifies SVHCs as identified under REACH and other substances of comparable concern as described below:

substances presenting a level of concern comparable to substances of very high concern which are not on the list referred to in Article 59 (1) of Regulation (EC) No 1907/2006. The list of these substances and their updating are set by order of the Minister responsible for the environment after notice of the National Agency for Food, Environmental and Occupational Health Safety.  (Source: unofficial online translation of excerpt from Decree)

The official Decree is available on the French government website[1]. This legislation could lead to a France specific version of an online database (similar to SCIP) as proposed by France earlier this year.

[1] France Decree No 2021-1285, https://www.legifrance.gouv.fr/download/pdf?id=qRpFOTNcN_R1TAogK7qOOostvrbVw7vibSIX3L_C8eE=

California – Four Substances Added to Proposition 65

The California Office of Environmental Health Hazard Assessment (OEHHA) added four substances to the Proposition 65 list of substances known to the State of California to cause cancer. The Proposition 65 notice of the four new substances is posted on the OEHHA website[1].

The substances are:

  • tetrahydrofuran (CAS No. 109-99-9),
  • 2-ethylhexyl acrylate (CAS No. 103-11-7),
  • methyl acrylate (CAS No. 96-33-3), and
  • trimethylolpropane triacrylate, technical grade.

The listing came into effect on December 17, 2021. Proposition 65 provides for a one-year transition period, therefore products that are an exposure risk for any of these substances will have until December 17, 2022 to meet the warning label requirements.

[1] OEHHA prop 65 notice, https://oehha.ca.gov/proposition-65/crnr/notice-interested-parties-chemicals-listed-effective-december-17-2021-known