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The effect of partial substitution refers to the impact that replacing a portion of a component or material in a process or product has on the overall performance, quality, or characteristics of that process or product.
Typically, manufacturers, suppliers, or organizations that make changes to their product formulations or processes are required to file the effect of partial substitution, especially if it impacts regulatory compliance or product safety.
To fill out the effect of partial substitution, one must provide information on the components being substituted, the amount of substitution, the effects on performance and quality, and any relevant data supporting the change, often in a designated format set by regulations.
The purpose of effect of partial substitution is to evaluate and document the implications of changing materials or components within a product, ensuring that such changes do not adversely affect safety, compliance, and functionality.
The information that must be reported includes the details of the original components, the substituted materials, the rationale for substitution, expected impacts on product performance and safety, and any test results or data that substantiate the changes.
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