ECD Compliance Launches EU SCIP Database Services

ECD Compliance has launched services to help manufacturers, suppliers, and solution providers understand and meet the emerging requirements for the European Substances of Concern in Products (SCIP) database.

SCIP submissions pose new challenges for manufacturers, importers, and distributors while enforcement becomes easier — the EU authorities know which type of products typically contain SVHCs and they will be able to check the online database to see if the substances have been properly reported. Manufacturers need to collect additional information from suppliers, interpret and compile the data into the format specified by ECHA, and then submit into the online SCIP database.

ECD Compliance will keep your organization up to date on regulatory developments and on emerging industry practices for SCIP. The service may be scaled up to support supplier engagement, data collection processes and SCIP data compilation.

Under REACH Article 33, manufacturers are already required to provide SVHC information to customers in the EU.   The new SCIP reporting obligations require duty holders to submit this and other information about the product and the first article containing the SVHC into the database. This information includes tariff codes, article identifiers, material category, concentration information, EU production, etc.  This raises several concerns including protection of confidential business information (CBI).

Contact ECD Compliance for more information on the SCIP services.

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

EU – ECHA Hosts SCIP Workshop

On November 12, 2019, ECHA hosted a workshop in Helsinki on the upcoming SCIP database. The workshop included several presentations from ECHA including an overview of the database, reporting requirements, data format, and protection of CBI, an industry presentation on global supply chains, a presentation on the view from waste operations, and an NGO presentation on use cases for the presentation.  Several challenging questions and use cases were raised that ECHA said they will need to investigate. These included reporting challenges associated with multiple sources of suppliers parts and what happens when a product has multiple configurations that impact the number of articles with SVHCs.

Four Substances Added to the REACH Candidate List — January 2020

The European Chemical Agency (ECHA), on January 16, 2020 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.  There is now a total of 205 SVHCs on the REACH Candidate List. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE – two of the four SVHCs are possible EEE constituents.  The IEC 62474 DSL was also updated on January 16, 2020.

Substance nameECCASExamples of use(s) (ECHA)
Diisohexyl phthalate276-090-2 71850-09-4Not registered under REACH.
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone404-360-3119313-12-1The substance is used in polymer production
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one400-600-671868-10-5The substance is used in polymer production
Perfluorobutane sulfonic acid (PFBS) and its salts  --Used as a catalyst/ additive/reactant in polymer manufacture and in chemical synthesis. It is also used as a flame retardant in polycarbonate (for electronic equipment).

EU SCIP Database Support in IEC 62474

The IEC 62474 International Material Declaration standard was revised in 2018 as part of a periodic review.  The revised International Standard was published in November 2018, introducing several new capabilities based on emerging regulatory requirements, user feedback, and the needs of other industries.  This included a new Declaration for Compliance module and additional support for EU REACH compliance and the upcoming EU Substance of Concern in Products (SCIP) database.  The changes were also intended to make the standard more useful to industries other than the electrotechnical products.  This had been requested by National Committees who intended to use the standard across a broad range of industries from the chemicals through all downstream manufacturers

Adoption of IEC 62474 as European and National Standards

IEC 62474 has been adopted as the European standard for material declaration (EN 62474).  It’s also been adopted as National Standards by several other countries including Japan, China, and Brazil.

Support for Supplier Declaration for EU SCIP Database Continue reading

EU – ECHA Publishes Data Format for SCIP Database

On October 31, 2019, ECHA published the data format that manufacturers, importers, and distributors will need to follow to submit data into the Substances of Concern in Products (SCIP) database. ECHA is currently developing a prototype system that it expects to have available for public testing in late January next year.  The fully functional system for duty holders to start submitting information is expected to be ready in October 2020.  The legal obligation to have submitted SVHC information starts in just over a year on January 5, 2021.

ECHA is providing three methods for duty holders to submit their article and substance information:

    1. Online submission via a web-based user interface;
    2. Offline using the ECHA IUCLID tool and then submitting manually;
    3. System to system – a company’s own IT system creates all of the submissions according to the IUCLID data format and then uses a system-to-system portal to submit multiple records into the system.

The same information needs to be provided regardless of which submission method is used.  The system-to-system will be most efficient for large organizations with many products containing SVHCs and by solution providers who can afford the custom IT development. The cloud-based approach will be well suited for organizations that need to make only a few submissions and don’t wish to undertake the training needed to use the IUCLID tool.

The ARTICLE XML schema published by ECHA gives us a good indication of the data needed for submission.  The schema bundles the information into data groups (see Figure 2) for:  Identifiers, Categorization, Characteristics, Safe Use Instructions, Complex Object Components, and Concern Elements. The Concern Element contains information about the SVHC in the article and the type of material/mixture that the SVHC is contained in.

 

Figure 2: Structure of Article into data groups

 

 

 

 

 

ECHA also revealed that several of the data fields will use picklists provided by ECHA. This means that an exact entry from the list will need to be submitted instead of free text. Data fields using picklists include:

    • Primary article identifier (Type) (e.g. EAN, GPC, GTIN, with option for other)
    • Other article identifier (Type) (e.g. EAN, GPC, GTIN, with option for other)
    • other names (Type) (e.g. brand, model, type with option to specify other)
    • Article categories (i.e. CN codes)
    • Produced in European Union
    • Unit of measure for characteristics
    • Candidate List Version
    • Concentration range
    • Material category
    • Additional material characteristics
    • Mixture category
    • Language of disassembly instructions

There is also a data field to indicate that the Candidate List Substance is no longer present within the article.

The ARTICLE XML schema is included as part of the latest release of the ECHA IUCLID data format (IUCLID 6.4) and is available on the ECHA website.  ECHA updates the IUCLID format once a year.

EU – ECHA Proposes 18 Substances for REACH Authorisation List

On October 1, 2019, the European Chemical agency (ECHA) submitted it’s ninth recommendation to the European Commission for substances to be added to the REACH Annex XIV Authorisation List. This recommendation includes 18 substances that are currently on the REACH Candidate List of SVHCs (Table 1).

When a substance is added the Authorisation List it’s given a sunset date.  Once the sunset date has passed, no one in the EU may manufacture or use the substance unless they’ve been granted an authorisation to do so.

Table 1: SVHCs recommended for REACH Annex XIV

NameEC NumberCAS NumberRecommendation year
4,4'-isopropylidenediphenol (bisphenol A; BPA)201-245-8May 7, 19809 (draft: September 2018; final: October 2019)
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”™) covering any of its individual anti- and syn-isomers or any combination thereof9 (draft: September 2018; final: October 2019)
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-HPbl)9 (draft: September 2018; final: October 2019)
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)239-622-415571-58-19 (draft: September 2018; final: October 2019)
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE)9 (draft: September 2018; final: October 2019)
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)209-218-2561-41-19 (draft: September 2018; final: October 2019)
Dioxobis(stearato)trilead235-702-812578-12-09 (draft: September 2018; final: October 2019)
Fatty acids, C16-18, lead salts292-966-791031-62-89 (draft: September 2018; final: October 2019)
Trilead dioxide phosphonate235-252-212141-20-79 (draft: September 2018; final: October 2019)
Sulfurous acid, lead salt, dibasic263-467-162229-08-79 (draft: September 2018; final: October 2019)
[Phthalato(2-)]dioxotrilead273-688-569011-06-99 (draft: September 2018; final: October 2019)
Trilead bis(carbonate) dihydroxide215-290-61319-46-69 (draft: September 2018; final: October 2019)
Lead oxide sulfate234-853-712036-76-99 (draft: September 2018; final: October 2019)
Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] [The individual cis- [2] and trans- [3] isomer substances and all possible combinations of the cis- and trans-isomers [1] are covered by this entry]201-604-9"236-086-3"238-009-985-42-7"13149-00-3"14166-21-39 (draft: September 2018; final: October 2019)
Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] [The individual isomers [2], [3] and [4] (including their cis- and trans- stereo isomeric forms) and all possible combinations of the isomers [1] are covered by this entry]247-094-1"243-072-0"256-356-4"260-566-125550-51-0"19438-60-9"48122-14-1"57110-29-99 (draft: September 2018; final: October 2019)
Tetraethyllead201-075-478-00-29 (draft: September 2018; final: October 2019)
2-methoxyethanol203-713-7109-86-49 (draft: September 2018; final: October 2019)
2-ethoxyethanol203-804-1110-80-59 (draft: September 2018; final: October 2019)

There are currently 43 substance entries on the REACH Annex XIV Authorisation List with an additional 58 entries recommended but not yet implemented (including the most recent 18 submissions).

China — RoHS 2 Conformity Assessment in Effect

The China RoHS 2 conformity assessment requirements came into effect on November 1, 2019.  Manufacturers and importers of EEE products that are in the batch 1 product list had to either (1) complete voluntary certification with an accredited certification lab or (2) complete necessary registration and document submission for self-declaration.

China RoHS 2 Batch 1 Products

The batch 1 products that are in scope of the substance restrictions and conformity assessment obligations include: Refrigerator, Air conditioner, Washing machine, Electric water heater, Printer, Copier, Fax machine, TV set, Monitor, Microcomputer, Mobile phone, and Telephone.

China RoHS 2 Self-Declaration

For the self-declaration path, the manufacturer (or importer) registers on a centralized government system known as the “China RoHS Public Service Platform”.  The manufacturer then submits a completed self-declaration form and technical documentation demonstrating conformance to the substance requirements. There were several unknowns as to exactly how the system would operate and what documents had to be submitted, but that become clearer once the platform went live in early October. The China RoHS Public Service Platform is accessible at http://chinarohs.miit.gov.cn

During a recent presentation on the self-declaration approach, two types of documentation were discussed: (1) a Product Test Report or (2) Suppliers Conformity Report based on hazardous substance assessment of assemblies, parts and components.  This second approach is like European self-declaration using EN 50581/ IEC 63000. In fact, China adopted the IEC 63000 standard on restricted substance technical documentation as a China National standard (GB/T 36560-2018) for this purpose.

The completed self-declaration form needs to be submitted in simplified Chinese.

Figure 3: China RoHS Public Service Platform

 

 

 

 

 

 

Manufacturers should carefully review official publications and guidance in order to ensure that they are meeting the compliance requirements for China RoHS 2.

EU – Ecodesign Implementing Measure for Electronic Displays Approved

The revised implementing measure for electronic displays was approved by the European Commission on October 1, 2019. It establishes energy efficiency requirements and a variety of other leading ecodesign measures.

Scope

The regulation includes computer monitors, TVs and digital signage displays but excludes specialized displays including small displays (e.g. less than 100 sq. cm – such as in a mobile phones), projectors, all-in-one video conference systems, medical displays, virtual reality headsets displays integrated into military equipment. It also excludes displays that are integrated into products that are already covered by another ecodesign implementing measure – details of the scope are provided in Article 1 of the regulation.

Timeline and Conformity Assessment

The new ecodesign requirements for electronic displays will take effect for products placed on the EU market starting on March 1, 2021 with a stricter set of energy efficiency requirements taking effect two years later on March 1, 2023.

Conformity assessment needs to be either to the internal design control system set out in Annex IV to Directive 2009/125/EC or the management system set out in Annex V to that Directive.

Eco-design Requirements

In addition to the energy efficiency requirements, the ecodesign regulation also includes several “best-in-class” eco-design requirements:

  • Auto-standby mode
  • Design for dismantling, recycling and recovery
    1. Joining, fastening or sealing techniques do not prevent the removal, using commonly available tools, of the components requiring selective treatment that are specified in the WEEE Directive.
    2. Dismantling information needed to access any of the components specified in the WEEE Directive as requiring selective treatment need to be available on a free-access website
    3. In general, plastic components heavier than 50g need to be marked with the type of polymer and the flame retardant (if applicable).
    4. If the product contains cadmium (e.g. in quantum dots), the product needs to be marked with the “Cd” logo.
    5. Halogenated flame retardants are not permitted in the enclosure and stand
  • Design for repair and reuse
    1. Availability of spare parts with a maximum delivery time of 15 working days
    2. Access to repair and maintenance information
  • Information availability
    1. Latest available version of firmware must be available for a minimum of 8 years
    2. Product info sheet shall indicate guaranteed availability of software and firmware updates, spare parts, and product support.

The ban on halogenated flame retardants in the enclosure and stand was added late in the regulatory development process and has raised concern in the bromine chemicals industry.