There are many old and new environmental compliance requirements that request full material disclosure on components supplied. This has been a continual source of conflict, especially in the rubber industry.
Rubber formulations are comprised of many different chemicals, which are specifically added to meet a given requirement. Rubber formulations are much more complex than plastic compounds that may be composed of a given polymer and some sort of filler. Metal is also simpler than rubber with a predetermined composition.
The development of a rubber compound is a long and arduous task, which consists of mixing several lots of rubber and hours of laboratory testing. There can be up to 20 different chemicals in a given formulation, each playing a supportive role in the overall properties of the cured rubber compound.
Since the development of rubber compounds is such a unique process, there are many regulations that rubber chemists must follow. Here are some of the most critical rules set in place:
IPC 1752
A few years back, the electronic industry came up with the form IPC 1752. This form can be used to give the material composition of any type of part, ie plastic, metal or rubber. This has long been the standard for Full Material Compositions (FMD), which requires the supplier to list all components and the substances with the CAS, including the registry number and weight of each ingredient.
International Material Data System (IMDS)
This system was first implemented by all automotive groups. Suppliers again enter the CAS number and percentages of each ingredient for a material. That material is then associated with a part so customers can run reports on environmental compliance. This system is especially helpful for companies that have multiple components in an assembly.
Proposition 65
Officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, this is an important law passed by California. This law includes a long list of chemicals that are deemed cancer-causing or reproductive toxicity. Suppliers to the California market must know if these chemicals are in their products so they can report and label the product correctly.
European Union Medical Device Regulations (EU MDR)
This is a relatively new requirement in the medical field, especially for suppliers to the EU market. Restrictive and regulated chemicals are being added to a list. Companies making medical products are required to know if these chemicals are in their components. The typical limit is 0.1% by weight or 1,000 ppm. Under this limit is not required to be reported.
Most rubber companies will provide material declarations stating whether or not these chemicals are part of the formulation corresponding to the request regulations. Rubber chemists are reluctant to give FMD to prevent any unauthorized duplication of their compound.
For example, Apple Rubber spent almost a year developing a compound for the propane industry. Many plasticizers were studied to ensure they were not extracted by the propane which acted as a solvent to most rubber oils. Once exposed to the propane, the oils would extract out, causing the rubber compound to shrink after being exposed to normal air. These types of advantages are important to be competitive with other rubber molders. Providing FMD to customers would allow rubber compounds to be duplicated and loss of intellectual property.
Apple Rubber provides many different rubber formulations for o-rings, gaskets, custom molded shapes and housing seals. Our compounds are designed to meet the highest quality and performance. We will work with our customers to provide all the required environmental compliance possible.
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