EU – ECHA Development of SVHC Database

Following the amendment in June of the EU Waste Framework Directive, the European Chemical Agency (ECHA) posted a press release on July 11th acknowledging that it will develop a new database on “the presence of hazardous chemicals in articles by the end of 2019 for waste treatment operators and consumers”. Companies producing, importing or selling articles that contain REACH Candidate List SVHCs will need to submit information about the products and the SVHCs by the end of 2020.

With the metal lead (Pb) now included on the Candidate List, nearly all EEE products will need to be registered in the database. ECD Compliance will follow ECHA progress in developing the database and reporting regularly.

EU – RoHS Phthalate Restriction Starts in One Year

Manufacturers are reminded that the phthalates restrictions (DEHP, DBP, BBP, DIBP) in EEE products start to take effect in less than one year.  The date that a specific EEE product needs to comply depends on the product category as shown in Table 1. Phthalates have been commonly used in plastic materials, especially wire and cable sheathing, requiring many products to be redesigned to substitute the parts that are non-conformant.  Technical documentation files also need to be updated.

Placed on the Market

EEE products need to comply if they are “placed on the EU market” on or after the date that the restriction take effect. For imported products, “placed on the EU market”, typically refers to the import date.  If a manufacturer has a tight transition timeline for its products, it’ll be important to closely manage the inventory that is not phthalate-free to ensure that it’s placed on the market before the deadline.

Table 1: Date of phthalate restrictions based on product category

Product CategoryDate of phthalate restrictions
All EEE Categories except as specified belowJuly 22, 2019
Medical devices (Category 8)
(including in vitro medical devices)
July 22, 2021
Monitoring and control instruments (including industrial monitoring and control instruments)
(Category 9)
July 22, 2021
Toys that are already subject to restriction of DEHP, BBP, and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006DIBP – July 22, 2019
DEHP, BBP and DBP – n/a
Spare parts and cables for repair, reuse or upgrade of EEE that was placed on EU market before the phthalate restriction came into effectn/a

Phthalate substances and thresholds

The RoHS Directive (2011/65/EU), Annex II was amended by Delegated Directive (EU) 2015/863 to add the four phthalate substances. The substances and maximum concentration in homogeneous material are:

  • Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
  • Butyl benzyl phthalate (BBP) (0,1 %)
  • Dibutyl phthalate (DBP) (0,1 %)
  • Diisobutyl phthalate (DIBP) (0,1 %)

Technical Documentation

The technical documentation files (as per EN 50581 or IEC 63000) will need to be updated to reflect the additional substances – even if no redesign was required, the technical documentation still needs to be updated with supplier documentation and other documentation to demonstrate that the four phthalates aren’t present.

ECD Compliance can provide support to manufacturers and suppliers in implementing IEC 63000 to develop technical document for a EEE product being imported into the EU or other jurisdictions with RoHS regulations.

EU – Ten SVHCs Added to REACH Candidate List

The European Chemical Agency (ECHA), on June 27, 2018 added ten additional substances to the EU REACH Candidate List. The new SVHC entries are listed in Table 1. The IEC 62474 Validation Team has reviewed the substances for potential uses in EEE. The typical EEE applications (where applicable) are included in the table as are general uses (provided by ECHA).  There are now a total of 191 SVHCs on the REACH Candidate List.

Table 1: Ten SVHCs Added to REACH Candidate List

NameDescriptionEC no.CAS no.General UsesTypical EEE Applications
Benzene-1,2,4-tricarboxylic acid 1,2 anhydridetrimellitic anhydride; TMA209-008-0552-30-7Used in the manufacture of esters and polymers.
Benzo[ghi]perylene205-883-8191-24-2Not registered under REACH. Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers
DecamethylcyclopentasiloxaneD5208-764-9541-02-6Used in washing and cleaning products, polishes and waxes and cosmetics and personal care products.Siloxanes are monomers used to manufacture silicones. Residuals may remain in silicone polymers and copolymers.
Dicyclohexyl phthalateDCHP201-545-984-61-7Used in plastisol, PVC, rubber and plastic articles. A further use is also as a phlegmatiser and dispersing agent for formulations of organic peroxides.Plasticizer, dye, pigment, paint, ink, manufacture of adhesive, lubricant
Disodium octaborate234-541-012008-41-2Used in anti-freeze products, heat transfer fluids, lubricants and greases, and washing and cleaning products.Wooden veneer sheets and pressed wooden panels (as a constituent within the starch adhesive), as a flame retardant, as stabilizer in aminoplastic resins, and as a biocide in professional and industrial wood preservation.
DodecamethylcyclohexasiloxaneD6208-762-8540-97-6Used in washing and cleaning products, polishes and waxes, cosmetics and personal care products.Siloxanes are monomers used to manufacture silicones. They may remain as unreacted in silicone polymers and copolymers, used in many electrotechnical equipment product categories.
EthylenediamineEDA203-468-6107-15-3Used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, pH regulators and water treatment products.
Lead231-100-47439-92-1Used in metals, welding and soldering products, metal surface treatment products, and polymers.Steel, aluminum and copper alloys, lead acid batteries, solder and other applications
OctamethylcyclotetrasiloxaneD4209-136-7556-67-2Used in washing and cleaning products, polishes and waxes and cosmetics and personal care products.Siloxanes are monomers used to manufacture silicones. They may remain as unreacted in silicone polymers and copolymers, used in many electrotechnical equipment product categories.
Terphenyl, hydrogenated262-967-761788-32-7Used as a plastic additive, solvent, in coatings/inks, in adhesives and sealants, and heat transfer fluids.Plasticizers, sealants, epoxy adhesives, paints and heat sinks

Impact on EEE manufacturers

The REACH communication obligations take effect immediately for the newly added SVHCs. Unfortunately, Given that the substance “Lead” was added, the update creates a particularly difficult challenge for EEE manufacturers who now need to disclose Lead as an SVHC.  Lead (as an element) is used in many EEE products (allowed under RoHS exemptions). Note: this specific SVHC entry is applicable to lead as a stand-alone element and not as compound and is relevant to lead in several RoHS exemptions.

The EEE Industry declarable substances list was updated on July 7, 2018 to reflect the new SVHCs that are relevant to the EEE products. Please see the article on the IEC 62474 update in IEC62474 blog http://rohs.ca/iec62474 .

EU – Sweden Proposes RoHS Restriction of MCCP

The European Commission has received a proposal from Sweden to restrict medium-chained chlorinated paraffins (MCCP) under the EU RoHS Directive.  MCCPs are one of the seven priority substances that were recently out for public consultation as part of a RoHS review.  Rather than waiting for the due course of considering MCCP under the current RoHS review, Sweden is proactively pushing for the restriction.

MCCPs are used in EEE as a flame retardant and plasticizer in certain plastic materials such as PVC used in cable sheathing.

The proposal is now with the European Commission for next steps.

EU – ECHA Database on SVHCs in Products

The European Commission is moving forward with a new database for data on SVHCs in articles. ECHA is contracted to develop the database; which is considered by the Commission to be a part of interface between chemical, product, and waste legislation.  Product manufacturers will in turn be required to submit data on the SVHCs that are present in the products as per the reporting requirements of REACH Article 33 (SVHCs in articles).

Discussion is underway between some industry organizations and the European Commission on the proposed database and the challenges of implementing such a system.

The revised waste legislation[1] that mandates the creation of such a database was published on June 14, 2018. The legislation comes into force after 20 days and the database needs to be operational 18 months thereafter (January 5, 2020) (Article 9, paragraph 2). Once the database is in place, article suppliers (e.g. importers) are required to provide information on SVHCs to the database within 30 months of the amending Directive coming into force (January 5, 2021) – this is specified in Article 9(1)(i) and is excerpted below:

(i) promote the reduction of the content of hazardous substances in materials and products, without prejudice to harmonised legal requirements concerning those materials and products laid down at Union level, and ensure that any supplier of an article as defined in point 33 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (*) provides the information pursuant to Article 33(1) of that Regulation to the European Chemicals Agency as from 5 January 2021;

Impact on EEE Manufacturers

A requirement for manufacturers and importers to submit all SVHCs in their products into a central database will create significant challenges and extra work for many manufacturers, especially SMEs. ECD Compliance will be monitoring the requirements and industry efforts as the details of the requirements become more visible.

[1] Amendment to EU Waste legislation, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018L0851&from=EN

EU – Seven RoHS Exemption Renewals are Published

The seven EU RoHS exemption renewals that the European Commission posted in March for Parliamentary scrutiny were formally published in the European journal on May 18th. The exemptions include: 6a, 6b, 6c, 7a, 7c-I, 24, and 34. The Commission has provided a transition period of just over a year, with the new exemptions coming into effect on July 1, 2019.

The new exemptions are excerpted in Table 1.

Table 1: RoHS Exemption Renewals Adopted

Exemption IndexExemption descriptionScope and dates of applicabilityStatus
6(a)Lead as an alloying element in steel for machining purposes and in galvanised steel containing up to 0.35 % lead by weightExpires 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.
Published
6(a)-ILead as an alloying element in steel for machining purposes containing up to 0.35% lead by weight and in batch hot dip galvanised steel components containing up to 0.2% lead by weightExpires on 21 July 2021 for categories 1-7 and 10.Published
6(b)Lead as an alloying element in aluminium containing up to 0,4 % lead by weightExpires 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.
Published
6(b)-ILead as an alloying element in aluminium containing up to 0,4 % lead by weight, provided it stems from lead-bearing aluminium scrap recyclingExpires on 21 July 2021 for categories 1-7 and 10.Published
6(b)-IILead as an alloying element in aluminium for machining purposes with a lead content up to 0,4 % by weightExpires on 18 May 2021 for categories 1-7 and 10.Published
6(c)Copper alloy containing up to 4 % lead by weightExpires on:
− 21 July 2021 for categories 1-7 and 10;
− 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.
Published
7(a)Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)Applies to categories 1-7 and 10 (except applications covered by point 24 of this Annex) and expires on 21 July 2021.
For categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments expires on 21 July 2021.
For category 8 in vitro diagnostic medical devices expires on 21 July 2023.
For category 9 industrial monitoring and control instruments, and for category 11 expires on 21 July 2024.
Published
7(c)-IElectrical and electronic components containing lead in a glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compoundApplies to categories 1-7 and 10 (except applications covered under point 34) and expires on 21 July 2021.
For categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments expires on 21 July 2021.
For category 8 in vitro diagnostic medical devices expires on 21 July 2023.
For category 9 industrial monitoring and control instruments, and for category 11 expires on 21 July 2024.
Published
24Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitorsApplies to all categories; expires on:
− 21 July 2021 for categories 1-7 and 10;
− 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.
Published
34Lead in cermet-based trimmer potentiometer elementsApplies to all categories; expires on:
− 21 July 2021 for categories 1-7 and 10;
− 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.
Published

Impact on EEE Manufacturers

Most of the exemptions are renewed for the full five years for product categories 1-7 and 10 (starting with the original expiry date of July 21, 2016 until July 21, 2021) with a few exceptions:

  • Exemption 6a) lead in steel alloy has a reduced scope — the lead in batch hot dip galvanised steel components has been reduced to 0.2% by weight.
  • In exemption 6(b)-II, the use of lead in aluminium for machining purposes expires on 18 May 2021 (three years from the date of publication). The European Commission is signalling that it intends to sunset the use of lead in aluminum, except where the lead content comes from recycled aluminum scrap.

Note that for product categories 8 and 9, the original exemption wording remains in effect for the full seven years from when that product category came into scope of the RoHS substance restrictions. This is July 21, 2024 for industrial monitoring and control instruments.

EU – Member States Adopt New Measure on EU Waste Legislation

As part of the European initiatives on circular economy, the EU member states have approved a set of “ambitious measures” related to EU waste legislation.  The challenging (and disconcerting) part of this for manufacturers is that the new measures include a proposal for producers to notify ECHA about the presence of SVHCs in articles for the purpose of providing recyclers with information that they may use during recycling operations.  This (if implemented) will be a significant challenge to EEE manufacturers and especially SMEs.

Impact on Manufacturers

Although the overall measures have been approved by EU members states, the regulation is still several steps from being officially adopted and there are still many details to be worked out.  Industry groups have already provided strong feedback on the proposal.  ECD Compliance will continue to monitor for any concrete developments.

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.

 

 

China – Publishes First Batch of EEE Products for RoHS Restrictions

The China Ministry of Industry and Information Technology (MIIT) has published MIIT Notice No. 15 2018 dated 15 March with ”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 come into effect on March 15, 2019.