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Regulatory Compliance & Legal Framework Flashcards

7 cards from real CPP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. The EU Packaging and Packaging Waste Directive (94/62/EC) sets essential requirements that include:

    Answer: Limits on heavy metals and minimization of packaging weight/volume

    The directive's essential requirements address minimizing packaging weight and volume, limiting hazardous substances including heavy metals (sum ≤100 ppm), and ensuring reuse/recovery.

  2. Under REACH regulation in the EU, packaging manufacturers that import or produce chemical substances above 1 tonne/year must:

    Answer: Register substances with ECHA

    REACH requires registration of chemical substances above 1 tonne/year with the European Chemicals Agency (ECHA) before they can be manufactured or imported into the EU.

  3. A packaging manufacturer discovers their supplier's ink contains a substance on the EU REACH SVHC Candidate List at >0.1% w/w. The manufacturer's obligation is to:

    Answer: Notify customers and provide safe use information upon request

    Suppliers of articles containing SVHCs above 0.1% w/w must notify recipients and provide information for safe use; consumer notification is required upon request.

  4. Which standard establishes testing protocols for child-resistant packaging under the Poison Prevention Packaging Act?

    Answer: ASTM D3475

    ASTM D3475 is the standard consumer safety specification for child-resistant packaging, defining test panels and pass/fail criteria aligned with PPPA requirements.

  5. The Lacey Act in the United States affects packaging manufacturers primarily because it:

    Answer: Prohibits trade in plants and plant products harvested illegally, including wood-based packaging

    The Lacey Act prohibits importing, exporting, or selling plants and plant products — including wood pallets and paper packaging — harvested in violation of applicable laws.

  6. Extended Producer Responsibility (EPR) laws for packaging, such as those enacted in Oregon and Colorado, require brand owners to:

    Answer: Fund and manage end-of-life collection and recycling of their packaging

    EPR laws shift financial and operational responsibility for packaging end-of-life management from municipalities to the producers who place packaging on the market.

  7. FDA's threshold of regulation (TOR) policy allows certain food-contact substances to be used without a food additive petition when dietary concentration is below:

    Answer: 0.5 ppb with no carcinogenic potential

    FDA's TOR policy exempts substances from formal regulation when dietary exposure is ≤0.5 ppb and the substance has no carcinogenic potential, based on negligible risk.