Issue: Material contains Ceramic materials and wares, chemicals CAS# 66402-68-4 or Ceramic materials and wares, chemicals, hydrolysis products with 3-(trimethoxysilyl)propyl methacrylate CAS# 444758-98-9

Per ECHA Ceramic materials and wares, chemicals (CAS# 66402-68-4) encompasses the various chemical substances manufactured in the production of ceramics. For purposes of this category of substances, a ceramic is defined as a crystalline or partially crystalline, inorganic, non-metallic, usually opaque substance consisting principally of combinations of inorganic oxides of aluminum, calcium, chromium, iron, magnesium, silicon, titanium, or zirconium which conventionally is formed first by fusion or sintering at very high temperatures, then by cooling.  This process generally results in a rigid, brittle monophase or multiphase structure. Ceramics which are produced by heating inorganic glass resulting in a change of its physical structure from amorphous to crystalline but no change in its chemical identity are not included in the definition of ceramics for this catetory..

This category consists of chemical substances other than by-products or impurities which are formed during the production of various ceramics and concurrently incorporated into a ceramic mixture. Its composition may contain any one or a combination of these substances. Trace amounts of oxides and other substances may be present. The following representative elements are principally present as oxides but may also be present as borides, carbides, chlorides, fluorides, nitrides, silicides, or sulfides in multiple oxidation states, or in more complex compounds:Aluminum,Lithium, Barium, Magnesium, Beryllium, Manganese, Boron, Phosphorus, Cadmium, Potassium, Calcium, Silicon, Carbon, Sodium, Cerium, Thorium, Cesium, Tin, Chromium, Titanium, Cobalt, Uranium, Copper, Yttrium, Hafnium, Zinc, Iron, Zirconium.

Because this is not a single substance but a category of substances, it is possible to fail to declare a GADSL substance that is included within the category.  In order to ensure that all GADSL listed substances are properly declared, the formulation of the ceramic should be examined and declared in IMDS per the requirements for declaring glass, ceramics, and enamels adopted in 2013. 

The methodology for representing ceramic, glass and enamel (hereinafter glass) materials in IMDS is explained in IMDS Recommendation 001a, Section 2.6 MDS creation for glass, silicate ceramic and enamel.

As part of that change, three new pseudosubstances were added to IMDS:

  • Ceramic without declarable substances
  • Glass without declarable substances
  • Enamel without declarable substances.

In order to revise a glass material to meet the 2013 IMDS criteria, you must perform a stochiometric analysis of the glass formulation.  The results of the analysis will tell you which substances are lumped into one of the pseudostances above and which are required to be declared.  It is possible that a substance in the original formulation does not need to be declared while one of its constituent elements does.  Any constituent element that is listed on the GADSL must be declared when revising the glass formulation to meet the 2013 requirements. 

Glass is a UVCB (Unknown or Variable composition, Complex reaction products or Biological materials). Traditionally the glass composition has been expressed in terms of oxides of the elements (SiO2, Na2O, K2O, CaO, MgO, PbO, etc.) present in the glass. However, these oxides are not necessarily present in the final glass. The raw materials in a glass formulation undergo physical and chemical processes which result in a random network where different elements are generally bonded together by oxygen bridges. The properties of the new glass material such as chemical resistance, mechanical resistance, color, etc. are a function of the network formed.

To more accurately represent glass composition, IMDS added the pseudosubstances listed above to replace the oxides traditionally shown for the composition of glass. However, IMDS’s primary focus is tracking declarable substances. As a compromise between the results of the physical and chemical changes that turn oxides into glass and the need to track regulated substances, IMDS requires that if an element contributed by any of the oxide substances is listed on the GADSL, it must be declared in the glass formulation in IMDS.

The decision tree below will help you decide which elements in the oxides can be included in the pseudosubstance and which must be listed separately. There may be additional elements that you wish to list separately because they need to be traceable for non-GADSL reasons. For example, the Conflict Mineral substances (tin, tantalum, tungsten and gold) are not on the GADSL but for compliance with the U.S. Conflict Minerals law, it is important to be able to trace them in your IMDS data.

Below is an example of applying the decision tree above to a traditional listing of oxides to make a new style glass material in IMDS.

A critical raw materials group has been added to the GADSL.  You can find the list of substances included in this group here: https://public.mdsystem.com/documents/d/imds-public-pages/gadsl-critical-raw-materials-list-17-08-23-xlsx.

Special Advice for Ceramic Materials

Ceramic materials can be categorized as one of three types:

  • Silicate ceramics;
  • Oxide ceramics; or
  • Non-Oxide ceramics.

Silicate ceramics are UVCBs. They have to be declared like glass using the pseudo substance Ceramic without declarable substances as shown in the example below.

Oxide ceramics may consist mainly of one single oxide or several oxides.

In this case of single oxide ceramics, the declaration has to be made as for normal materials, listing the oxide and all additional ingredients explicitly or as wildcard as shown in the example

In the case of oxide ceramics made from several oxides, they form a UVCB material during sintering. Therefore, they have to be declared like glass using the pseudo substance, Ceramic without declarable substances.

Non-Oxide ceramics are created of carbide or nitride and different amounts of binder and/or sintering additives. During sintering they form a UVCB. Therefore they have to be declared like glass, see above, using the pseudo substance Ceramic without declarable substances as shown below.

If any of the above ceramics contain other declarable substances, these substance have to be specified in the material, according to the general rules of IMDS Recommendation 001.

Action Required:

Perform a stochiometric analysis of the material and update the formulation based on the results.  You can learn more about how to do a stochiometric analysis here: https://www.youtube.com/watch?v=7pmgbu2CRs4 .

You can find a molecular weight calculator to assist with your analysis here: https://www.webqc.org/molecular-weight-of-Pb5B2SiO10.html.

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