Regulatory Affairs • Environmental Compliance

REACH Substance Compliance Review

Duration: 20 months • Role: Regulatory Affairs Specialist

Identifying which directives applied across the product's components (plastics, microcomputer, lead, and others) showed that environmental compliance has to be tracked at the component level, not the finished-device level, or a single restricted substance in a sub-assembly slips through unnoticed.

Context

The product's bill of materials spanned multiple component types (plastics, microcomputer, lead, and others), each potentially subject to different REACH directives. Regulatory needed a defensible, component-level position rather than a single finished-device declaration.

REACH Environmental Compliance SVHC

Primary Risks Identified

  • An undeclared restricted substance (e.g. lead) in a purchased component going unnoticed until a customer or regulator audit

Testing Approach

Cross-referenced supplier material declarations against the REACH SVHC candidate list, component by component, and flagged any substance above the reporting threshold.

REACH SVHC Candidate List Supplier Declarations Component-Level Review

Outcome

Produced a REACH declaration letter and a component-level substance checklist that gave Regulatory a defensible position for customer and distributor requests.

Key Lessons

Environmental compliance has to be tracked at the component level, not the finished-device level, or a single restricted substance in a sub-assembly slips through unnoticed.

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