SVHC Notification Duties Triggered by a Component Nobody Specified
Component level SVHC breaches above 0.1 percent trigger immediate REACH Article 33 and SCIP notification duties regardless of total assembly weight.
Weight-by-Weight Threshold
Meaning
The concentration limit of a specific substance in a plastic compound is calculated as the mass of the chemical divided by the total mass of the polymer. This weight-by-weight threshold determines whether a molded part must carry a regulatory warning or faces an outright import ban. This limit is often set at point one percent for hazardous additives.
Chemical Compliance
Polymers designed for medical devices or food packaging must undergo rigorous testing to ensure they do not exceed toxicological limits. Maintaining additive concentrations below the specified weight-by-weight threshold is a legal requirement for selling plastic goods in major consumer markets. This control ensures that chemical migration from the plastic remains within safe limits.
Additive Control
Compounders blend flame retardants, plasticizers, and colorants into resin formulations to achieve the desired mechanical properties. If these additives exceed the weight-by-weight threshold, the molder must declare their presence to the chemical database or reformulate the blend. This declaration process requires precise formulation records from the chemical supplier.
Quality Verification
Testing laboratories use advanced spectroscopy and extraction methods to analyze the composition of incoming resin shipments. Verifying that hazardous substances remain below the weight-by-weight threshold protects the injection molder from product liability claims and regulatory enforcement. This testing is especially important when using recycled resin, which can contain legacy additives from older plastic products.
Consistent analytical verification provides the documented evidence needed to prove compliance during regulatory audits.