Assent ComplianceDirector, Compliance Programs
Overview of an “FMD”
Methods for creating an FMD
IPC-1752A Class D
Creation of FMD in practice
In the electronics industry, this would mean 100% disclosure of every substance down to the homogeneous level
Without this level of disclosure, an FMD would not demonstrate compliance to the RoHS Directive
In an industry which does not have any regulatory requirement to restrict or disclose substances at the homogeneous level, this could mean 100% disclosure at the “Article” level (i.e. total concentration)
Having 100% disclosure at the Article level would support compliance to REACH SVHC communication requirements and a variety of other legal requirements
But... it only works if the format makes sense to exchange complicated data structures in a common format for one system’s output to be readable in another system
Otherwise, one is unable to perform analysis and judgement
To create a common structure, the format must contain logic within its data population
PDF Excel Word XML
HTML Pen and Pencil Mind reading
Provides a set of rules for encoding documents into a human and machine readable format
Without the rules, data exchanges would result in files being passed from one machine to another resulting in dump of uncommon data
IPC-1752A, Class D IPC-1754 (in development) IEC 62474 ChemSHERPA
Created a data exchange standard to support not only the requirements of RoHS and REACH, but also those to come in the future IPC-1752
First released as a PDF, but has not been supported in years
Currently available in XML
The most highly adopted standard for materials data exchange
Class A - Provides an answer to a query For example, Query for RoHS is answered by “Product meets EU RoHS
requirements without any exemption”
Class B - Provides the amount of different material classes within a product For example, 50% stainless steel, 25% polyvinylchloride, 25% zinc and its alloys
Class C - Provides substances details if above or below threshold against a specific list or lists of substances For example, Product contains DEHP at 0.25% after being asked for the
presence of SVHC substances
A
B
C
D
If I have a Class D, am I able to demonstrate compliance to all regulated substances?
Not necessarily
The standard has been created to be open for a variety of uses and many “fields” are optional
Not mandatory to include unique chemical identifiers (e.g. CAS #)... but highly recommended
Certain substances may contain regulated substances as a constituent (additives, stabilizers, plasticizers)
Substance names are not standardized (e.g. aluminum, aluminium)
Proprietary substances
Mandate a unique identifier if exists (e.g. CAS #)
Mandate all regulated substances must be reported What does that mean?
Mandate all substances on specific list be reported
Mandate a consistent method of proprietary
And many more
Assentcompliance.com/fmd-complete/
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October 20, 2016 | Chicago
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