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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.

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 – 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.

EU – RoHS Consultation on Substance Review and Exemption

The consultants for the European Commission have launched a public consultation on the list of restricted substances being considered for addition to the EU RoHS Directive (Pack 15).  The consultation runs from September 26, 2019 until November 7, 2019.

Substance Review and Inventory

The substances consultation focuses on updating the substance inventory (applicable to EEE) and with collecting comments on four of the seven substances that are being considered for the RoHS Directive. These substances are:

    • Indium phosphide;
    • Beryllium and its compounds;
    • Nickel sulphate and nickel sulfamate; and
    • Cobalt dichloride and cobalt sulphate.

The consultants indicated that a review of the remaining three substances will be launched later in 2019.

IEC/TC111 – New Project on Material Circularity

In October 2019, the IEC/TC111 committee will be launching a new project team to develop a guidance document on material circularity for the EEE industry. In the medium to long term, this may lead to additional supply chain communication requirements for tracking the use of recycled materials and reused parts in new product manufacturing.  The first meeting is scheduled for October 21, 2019 in Shanghai, China.

IEC 62474 Declarable Substance List Updated on January 15, 2019 with New REACH SVHCs

The IEC 62474 Declarable Substances List was updated on January 15, 2019, the same day that ECHA updated the EU REACH Candidate List with six additional Candidate List SVHCs.  The IEC 62474 Validation Team found that that five of these six substances are potential constituents of EEE. Details of the update are provided on the IEC 62474 blog posting.

Reporting REACH SVHCs using the is Article Flag in IPC-1754 Declarations

The EU REACH regulation applies significant requirements on product manufacturers to identify substances of very high concern (SVHCs) listed on the REACH Candidate List that are present in their products. Following a European Court of Justice ruling, the European Chemical Agency (ECHA) published a guidance document clarifying that the threshold level for reporting the SVHC is 0.1% of the first article in a product and not the finished product (as suggested in earlier ECHA guidance documents).  In the REACH regulation, article is defined as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” According to the ECHA guidance, the first article is when a substance is applied such that an article is first created and not based on a complex object that is made up of individual parts that are themselves articles.

This creates challenges for product manufacturers and requires them to obtain additional information from their supply chain on whether a SVHC is present (above 0.1%) in the first article of which it is a constituent.  For compliance assessment, a key piece of information needed by downstream manufacturers is the mass percent of a SVHC in its first article.

To provide this information in a material declaration, the substance and mass relative to the first article needs to be provided.  The challenge is how to communicate this within a material declaration.

How does IPC-1754 support REACH SVHC assessment

The IPC-1754 declaration standard supports this information requirement by allowing materials and subproducts to be reported in the declaration. The data exchange format also provides an (isArticle) flag for materials, subproducts, and the product so that the supplier can identify any object in the declaration as to whether or not it is an article.  This may be either a material (that meets the defn of article) or a subproduct.

How to determine if the mass percent of a substance is above 0.1% of the article

When a substance is reported in a declaration it includes mass information – this may be either the mass of the substance or a mass percent (the mass of the substance divided by the mass of the material or subproduct (or product) that the substance is assigned to in the declaration hierarchy).  However, the recipient of the declaration may not know enough about the manufacturing of the product (or its parts) to identify the first article. It’s best if the supplier identifies this first article and passes sufficient information down the manufacturing chain for downstream manufacturers to assess compliance requirements.  For the recipient to be able to determine the mass percent of the SVHC in the first article, the supplier needs to include the first article as an object in the declaration (this could be a material, subproduct or the product) and it needs to be identified as an article.

Examples of a single SVHC in the product

Figure 1 illustrates a simple declaration hierarchy of an SVHC (S1) that is included in a material (M1) which is included in part (P1) (which is the first article). Material M1 is identified as not an article (isArticle=False) and subproduct P1 is identified as the first article (isArticle=True) therefore the recipient is able to calculate that the mass percent of S1 in the first article (P1) is 0.2g / 10g = 2% (which is above the 0.1% threshold that triggers the REACH communication requirements). The top-level product is a higher level article (may be referred to as a complex object) and therefore also has isArticle=True.

There are instances where a material may have a specific shape and meets the definition of an article (see second example in Figure 2). In this case, the isArticle flag for material M1 is set to True and the SVHC mass percent in an article is 0.2g / 1.0g = 20%.

Figure 1: Simple example of a declaration with an SVHC in an article (subproduct)

Figure 2: Example with a material that is an article

 

 

 

 

 

 

 

 

 

 

 

In both of these examples, the SVHC content is above 0.1% triggering REACH communication obligations, but there are cases where only a small amount of the SVHC is present and the selection of the first article will impact whether or not the SVHC is present above or below this threshold.  It’s up to the supplier that first incorporates an SVHC into an article to identify this to downstream manufacturers

When there are multiple SVHCs added at different stages of Manufacturing

There may also be products that include more than one SVHC. In some cases, the SVHCs may be applied at different stages during manufacturing, resulting in a complicated declaration hierarchy. One such example is illustrated in Figure 3.

  • The substance S1 (an SVHC) is included in a plating material (M1) which is applied to a lead frame (SP1) which then becomes a plated lead frame (SP2).
    • SP2 is the first article that includes S1, therefore the mass % of S1 in an article is the (mass of S1) / (mass of SP2).
    • If this mass % is above 0.1%, then S1 has REACH obligations.
  • The substance S2 (another SVHC) is a constituent of die attach material that is applied to the die (SP3) and the plated lead frame (SP2) to become the die assembly (SP4).
    • In this case, SP4 is the first article for substance S2 and is used as the basis of the mass % calculation to compare to 0.1%.
  • Overall, in this declaration hierarchy of the IC, subproducts SP4 and SP2 are both first articles for different SVHCs, which creates a complex declaration.

For the recipient of a declaration to properly assess REACH obligations, it’s necessary for the supplier to declare the material or subproduct (or product) that is the first article and identify that it as an article (by using the isArticle flag).

Note: in some cases (for simple products), the product may be the first article (e.g. the product provided by a supplier may be a single piece of molded plastic) or the product may be a mixture (e.g. wet paint) and there is no article.

IPC-1754 Substance Declaration Standard Published

The IPC-1754 standard titled “Materials and Substances Declaration for Aerospace and Defense and Other Industries”[1] was recently published by IPC.  It’s a new standard that establishes requirements for exchanging material and substance data for products between suppliers and their customers for Aerospace and Defense, Heavy Equipment and other industries.

This standard covers the process for exchanging data on substances that may be present in materials in the product and substances that may be used in production, operations, maintenance, repair or overhaul/refurbishment.

IPC-1754 was developed to meet the broad range of requirements of Aerospace, Defense and several other industries that were involved in the development of the standard. The standard includes several innovative features to support compliance assessment against a variety of substance regulations and other uses such as obsolescence management. Features to assess compliance to EU REACH and similar regulations (including the ability to identify articles in the declaration hierarchy) were particularly important.

Some of the new features include:

  • support for declaring chemicals used in manufacturing and maintenance processes (more on this in  future posts);
  • flags to identify articles (as defined in the REACH regulation), homogeneous materials, and to indicate that this is a full substance declaration (FSD/FMD)  and/or includes all materials;
  • support for declaring that some information is “unknown”;
    • The unknown capability was especially added to help suppliers in industries that are new to material and substance declarations to provide information to downstream manufacturers,
  • use descriptors (more information coming in future posts)

IPC-1754 enables an external authority such as an industry association to specify external lists that provide the basis for a declaration by a supplier to a downstream requester. This includes the declarable substance list, a query list, and optionally a use descriptor list established by the declaration Authority. The Query List (QL) provides a set of product statements (also referred to as queries)  — the supplier answers each statement with either a “true”, “false” or “unknown”.  An example of such a statement is that the product contains a substance in the Declarable Substance List (DSL). The supplier than answers true or false depending on whether a DSL substance is included or not.

ECD Compliance was extensively involved in developing IPC-1754. Our principal consultant is a co-chair of the committee.  For information on the IPC-1754 standard, how it can be used by your organization, or other support to use the standard, contact ECD Compliance.

A joint press release on IPC-1754 by IPC and the International Aerospace Environmental Group is available.

[1] Note: This is the approved title for IPC-1754. The title in the published standard is incorrect.  A title that is several revisions out of date was inadvertently inserted during publication.  IPC is aware of the issue.

 

 

EU – Seven Substances Added to REACH Candidate List

In late December the European Chemical Agency (ECHA) announced that the Member State Committee approved seven substances of very high concern (SVHC) for addition to the REACH Candidate List and an update to the bisphenol A (BPA) entry as an Endocrine Disruptor. ECHA also indicated that the Candidate List update would be delayed from December to mid-January.

The Candidate List was subsequently updated on January 15, 2018. The new SVHCs and examples of EEE applications (identified by the IEC 62474 validation team) are listed in Table 1.

Table 1: SVHCs Added to REACH Candidate List (January 2018)

Substance NameDescriptionCAS no.Examples of EEE Applications
Benz[a]anthracene56-55-3, 1718-53-2Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
Cadmium carbonate513-78-0n/a
Cadmium hydroxide21041-95-2It is generated in the anodes of nickel-cadmium and silver-cadmium batteries during the discharge
Cadmium nitrate10022-68-1, 10325-94-7n/a
Chrysene218-01-9, 1719-03-5Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
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 thereof-Flame retardant for electric wire and cable covering material
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)-n/a

Impact on EEE Manufacturers

Manufacturers, importers and distributors have immediate REACH Article 33 obligations to disclose information about any of these SVHCs in their products if above the threshold of 0.1% in an article. Four of the SVHCs are considered to be possible constituents of EEE products (as indicated in the table).

The other three SVHCs are unlikely to be present.  They are unintentional by-products of manufacturing and/or use. The Cadmium hydroxide would only be present above 0.1% if the product contains a certain type of battery which has gone through multiple charge-discharge cycles.