Category Archives: IPC-1754

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.