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.
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%.
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.
The IPC-1754 standard titled “Materials and Substances Declaration for Aerospace and Defense and Other Industries” 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.
 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.
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 Name||Description||CAS no.||Examples of EEE Applications|
|Benz[a]anthracene||56-55-3, 1718-53-2||Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers|
|Cadmium hydroxide||21041-95-2||It is generated in the anodes of nickel-cadmium and silver-cadmium batteries during the discharge|
|Cadmium nitrate||10022-68-1, 10325-94-7||n/a|
|Chrysene||218-01-9, 1719-03-5||Impurities in carbon black, which is used as coloring agent in plastics and softener in rubbers|
|Dodecachloropentacyclo [126.96.36.199,9.02,13.05,10] octadeca-7,15-diene (â€œDechlorane Plusâ€â„¢)||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 â‰¥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.
In part 1 (Products Containing Mercury Regulations published in Canada) and part 2 (Canadian Mercury Regulations to Impose Tight Restrictions on Mercury in Batteries) of our series of articles on Canadian Products Containing Mercury Regulations we discussed the scope of the regulations and maximum concentration limits for batterieis and other products and how they compare to the EU RoHS Directive and the EU Battery Directive. In this part 3 of the series we will look at mercury exemptions, harmonized standards for product testing and spare parts. There are still numerous applications, particularly with mercury containing lamps whereby mercury is critical to proper functioning of the product.
Prohibitions and Exemptions
Under the Canadian Regulations, a product that contains mercury may not be manufactured or imported in Canada unless there is an applicable exemption or if the manufacturer or importer holds a permit issued under the Regulations. The exemptions are listed in the Schedule to the Regulations and each entry includes the product category, the maximum total quantity of mercury in the product, and the end date of the exemption.
The exemptions are similar to the EU RoHS exemptions but not identical. In general, the Canadian exemptions are more flexible, allowing slightly higher levels of mercury content for lamps. For example, item 2(a) of the Schedule specifies that a compact fluorescent lamp for general lighting purposes (≤ 25 Watts) may have up to 4 mg of total mercury per lamp. The comparable exemption in the EU RoHS Directive (exemption 1(a)) allows up to 2.5 mg of mercury per burner (this was originally 5 mg but was reduced to 3.5 mg in 2012 and then 2.5 mg as of January 1, 2013).
The applications (product categories) specified in the exemptions do not align perfectly between the two regulatory instruments, so manufacturers will need to perform a careful comparison to ensure that a product containing mercury meets the Canadian Regulations.
A renewal of most of the EU RoHS exemptions will occur in 2016 and it’s possible that the EU maximum allowable mercury levels will decline further.
The Canadian Regulations provide exemptions for other product categories that are not exempted under the EU RoHS Directive. Other exempted products relevant to the electrotechnical industry include:
- Scientific instrumentation for the calibration of medical devices or for the calibration of scientific research instruments;
- Scientific instrumentation used as a reference for clinical validation studies;
For determining the level of mercury content in products, the Canadian Regulations references IEC 62321-4:2013, entitled Determination of certain substances in electrotechnical products — Part 4: Mercury in polymers, metals and electronics by CV-AAS, CV-AFS, ICP-OES and ICP-MS, which is also referenced by the EU RoHS harmonized standard for technical document (EN 50581).
The Canadian Regulations provide an exemption for replacement parts – this is similar to the EU RoHS exclusion for spare parts.
Technical support on environmental product regulations
ECD Compliance provides manufacturers and suppliers with services to track global environmental product requirements and assess the impact to their products and markets, including the Canadian Products Containing Mercury Regulations.
The IEC 62474 Declarable Substance List (DSL) was updated (D11.00) on March 28, 2016 to reflect the September 2015 European Court of Justice (ECJ) interpretation of the term “article”. The ECJ ruling is important for OEMS and suppliers in determining whether a REACH Candidate List SVHC is above the 0.1 mass% threshold that triggers communication and notification obligations under the EU REACH regulation.
With the ECJ ruling addressed, the new “ReportingLevel” field, which was recently added to the database, was populated. The ReportingLevel field is intended to simplify for users the interpretation of the more complex reporting thresholds. Some of the reporting thresholds are difficult to interpret because of how they are written in the regulation.
There were a couple of additional minor changes were made to declarable substance groups and reference substances.
A more comprehensive summary is provided in our IEC 62474 blog.
Contact us for additional information on how ECD Compliance can assist your organization in using IEC 62474 for environmental compliance.
The EU is on the verge of classifying bisphenol A (BPA) as a category 1B substance, toxic for reproduction. This classification makes it much easier to regulate BPA and products containing BPA in the EU. For example, substances classified as category 1 carcinogens, mutagens or reproductive toxin can be banned from use in consumer products in the EU via a simplified procedure. The category 1B classification also opens the door to BPA being listed as an SVHC on the REACH Candidate List. See the article below on REACH registry of intentions.
The Member State committee backed the classification change in early February during its review of a series of changes to be implemented in the CLP (Classification and Labelling Protocol). The Commission will now send the draft Regulation to the European Parliament for scrutiny. Based on standard timelines, the new regulation could be published in the EU Official Journal around mid-2016. According to the draft regulation, the classification change would take effect 18 months after the regulation enters into force.
As part of the Commission’s December package on the Circular Economy , amendments to several waste management Directives were proposed, including WEEE, batteries, packaging and end of life vehicles (ELV). The amendments are mainly focused on how EU Member States report their takeback and recycling results; however for certain types of waste, such as packaging, the recycling levels have been increased.
The Commission has set the following target for waste management:
- a common EU target for recycling municipal waste of 65% by 2030;
- a common EU target for recycling packaging waste of 75% by 2030.
- material-specific targets for different packaging materials;
- • a binding landfill reduction target of 10% by 2030;
The last bullet means that by 2030, the Commission expects that only 10% of all waste in the EU goes to landfill. The other 90% needs to be recycled or used for energy recovery.
For packaging, the proposed Directive sets the following long-term recycling targets:
(i) no later than 31 December 2030 the following minimum targets by weight for preparing for reuse and recycling will be met regarding the following specific materials contained in packaging waste:
(i) 75% of wood;
(ii) 85% of ferrous metal;
(iii) 85% of aluminium;
(iv) 85% of glass;
(v) 85% of paper and cardboard.
After years of uncertainty surrounding China RoHS 2, China’s Ministry of Industry and Information Technology (MIIT) published the revised regulation on January 21, 2016. Starting July 1, 2016, companies that manufacture, import or sell Electrical and Electronic Products in China will need to comply with the new requirements. China RoHS 2 aligns more closely with EU RoHS than the original China RoHS but it still retains the unique labeling and documentation requirements and expands the requirements to many products that weren’t previously in scope.
The expanded scope combined with the short timeline for compliance will certainly be a challenge for many product manufacturers. Eliminating the exclusion for exported products also affects companies that have their products manufactured in China.
Manufacturers of products that are already EU RoHS compliant should have sufficient information on hand to compile the new China RoHS documentation; but products that aren’t yet EU RoHS compliant may present a challenge to their manufacturers. For example, industrial monitoring and control instruments and products that fall into Category 11 “Other EEE not covered by any of the categories above” aren’t subject to EU RoHS requirements until 2017 and 2019 respectively, but both need to meet the China RoHS 2 requirements this year. The requirement to identify all presence of the six hazardous substance groups, including uses that are covered by EU RoHS exemptions, can create a particular challenge.
The regulation, officially titled “Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products”, is generally aligned with the China RoHS 2 draft that was circulated in May 2015 with only a few minor surprises. As expected, the scope of the regulation is extended to all electrical and electronic products except for power generation, transmission and distribution equipment.
Definition of Electrical and Electronic Products
The definition of “Electrical and electronic products” refers to devices and accessory products which function by means of electric current or electromagnatic fields with rated working voltage up to and including 1500V DC and 1000V AC or which generate, transmit or measure such currents or electromagnetic fields. However, the definition explicitly excludes power generation, transmission and distribution equipment.
The six original EU RoHS substances are still the basis for hazardous substances in China RoHS 2; although a seventh entry of “Other harmful substances as regulated by the State” leaves the door open to additional substances such as the four phthalate substances added to EU RoHS.
Labelling and Hazardous Substance Disclosure
A hazardous substances table that indicates presence of any of the six substances and where in the product they are located was carried forward from China RoHS to China RoHS2 (Article 13). The “environmental protection use period” (EPUP) label is also still required (Article 14). The regulation states that both the substance table and the EPUP label should be displayed directly on product; although the regulation provides an alternative if necessary.
With the expanded scope of China RoHS 2, many additional products will need to display the EPUP label and the hazardous substances table as of July 1, 2016. The details of the hazardous substances table and the environmental protection use period are specified in the China standard SJ/T 11364-2014.
Similar to the substance restriction mechanism in its predecessor, China RoHS 2 includes a “Compliance Management Catalog” to implement substance restrictions, specify exemptions and provide timelines.
Compliance to China RoHS 2 will be based on a “conformity assessment system” instead of the CCC certification specified in the original China RoHS — details will be provided later. The regulation only states that MIIT working together with other organizations will “establish a creditable mechanism based on the result of the assessments”.
End of Life Information and Design for Environment
A number of subtle provisions have been added into the regulation for design for environment and to facilitate recycling. The exact expectations of these provisions aren’t specified in the regulation but may emerge over time in China national standards and the FAQ that’s expected sometime this year.
To provide some insight, we’ve pulled out a few examples of DfE implications from the regulation:
- Article 13 states that the hazardous substances table should provide information on what parts of the product may be recycled and information on possible impact on inappropriate use or disposal on the environment or health.
- Article 10 states that the producer/manufacturer shall adopt materials and technologies that protect the environment and human health, are easy to recycle and allow high product recyclability rates.
In the draft regulation released in May 2015, MIIT had removed the requirements on product packaging that were included in the original China RoHS. However, packaging was added back into the final version of China RoHS 2, although somewhat ambiguously. The new requirement states that mandatory standards and laws related to packaging must be met and that packaging materials must be nonhazardous, recyclable/biodegradable, and comply with national or industry standards.
The China RoHS 2 regulation applies to EEE products manufactured in China, imported into China or otherwise sold in China. Unlike the original China RoHS, it does not provide an exemption for EEE products that are manufactured for export.
Impact on Manufacturers
Companies that manufacture their product in China or sell product into China will likely be impacted to some degree by the new China RoHS 2 regulation. Products that were previously out of scope will need to comply with all of the marking and labeling requirements as of July 1, 2016.
The China RoHS 2 regulation is available from the MIIT website (in Chinese). An English translation of the regulation has been made available by Foley & Lardner LLP: English reference translation of the new China RoHS 2 regulation.
The United Arab Emirates has updated its RoHS proposal to align the timing of the phthalate restrictions with those of the EU RoHS Directive. The original proposal had the phthalate restrictions coming into effect at the same time as all other substance restrictions.
The restriction on the four phthalate substances is now specified in the proposal (clause 9.1.2) as coming into effect on July 22, 2019 for most EEE products (see text box). The reference to clause 9.1.1 is with respect to medical devices and monitoring and control instruments.
In a subsequent comment from the EU, the EU reiterated additional concerns about the mechanism by which exemptions were being implemented and maintained.