Laws and Regulations Affecting the Packaging Industry

General Laws and Regulations Affecting the Packaging Industry

  • Introduction

    • Discussion on laws and regulations within the packaging industry.

  • Code of Federal Regulations (CFR)

    • Definition: Abbreviated as CFR, the Code of Federal Regulations houses all legislative details relating to laws and regulations.

    • Description: A comprehensive volume organized under different title numbers, sections, and further details, serving as the primary resource for legal guidelines in packaging.

Standards of Practice

  • Overview

    • Definition: Not legally binding but can be enforced in lawsuits as if they were laws.

    • Example:

    • A manufacturer using unconventional packaging may face legal consequences if their product fails, as they could be held to the prevailing standard of practice in the industry.

Historical Legislation Impacting Packaging

  • Food and Drug Law of 1906

    • Description: One of the earliest laws impacting packaging indirectly.

  • Food, Drug and Cosmetic Act of 1938

    • Significance: Landmark legislation aimed at consumer protection, but it contained many loopholes and has undergone numerous amendments.

    • Provisions:

      • Banned poisonous substances in food.

      • Attempted to address overpacking issues, yet effectiveness has been debated.

    • Context: Further exploration of this Act is provided in an advanced class called "Packaging and Society."

  • Food Additives Amendment of 1958

    • Relationship: Amended the Food, Drug, and Cosmetic Act of 1938, directly affecting packaging.

    • Definition: Food additives are any substances that directly or indirectly become part of food.

    • Implications for Packaging: Packaging components that leach into food are subject to safety regulations as they are treated as part of the food.

    • Major Provisions:

    1. Definition of food additives.

    2. Shifted the burden of proof regarding safety to the industry.

    3. Delaney Clause: Outlaws carcinogenic additives.

    4. Established generally recognized as safe (GRAS) additives.

    5. Defined good manufacturing practices (GMP).

    • Categories of Exemptions:

      • Any substance unlikely to become part of food.

      • Generally recognized as safe substances (GRAS).

      • Items on the prior sanctioned list.

      • Substances passing tests at levels considered negligible, such as less than 50 parts per million (ppm) or 50 parts per billion (ppb).

Example

  • Use of Black Polyethylene in Food Packaging

    • Description: Black polyethylene colored with carbon black (a carcinogen) is usable as food packaging if:

    • It has an absolute barrier layer (like foil) to prevent migration of harmful components into the food.

Prior Sanctioned Ingredients

  • Overview

    • Definition: These are ingredients allowed prior to 1938 and cannot expand in the list after 1958, but can contract.

    • Implication: New safety analyses could lead to substances being removed if proven harmful.

New Polymer Development Process

  • Testing Protocol

    • Use of rats for lifecycle studies, tracking from gestation to death.

    • If found safe, a food additive petition is filed with the FDA for approval to use in manufacturing.

Fair Packaging and Labeling Act of 1966

  • Key Features

    • Required nutrition labels, ingredient lists in descending order, company information, and specified formats for quantity declarations.

    • Regulations: Required information appears in the lower 30% of the principal display panel (PDP) and in both metric and US customary measures.

  • Nutrition Labeling and Education Act of 1990

    • Revisions to Fair Packaging and Labeling Act from 1966.

    • Specifications for label formats and dietary standards based on 2000 and 2500 calorie diets.

    • Defined claim statements (e.g., low fat, reduced cancer risk) that must have scientific backing.

    • Exemption: This act does not apply to dietary supplements.

Significant Packaging Laws

  • Tamper Evident Law

    • Background: Introduced as a response to a poisoning incident involving cyanide-laced Tylenol resulting in several deaths in 1982.

    • Definition: Ensures consumers can visually confirm a package has not been tampered with before use.

    • Clarification of terminology:

    • Tamper Evident: Indicates signs of tampering.

    • Tamper Resistant: Implies difficulty in access but is not the correct term.

  • Poison Prevention Act of 1970

    • Reason: Aimed to reduce accidental poisonings in children.

    • Regulations: Enforced child-resistant packaging and warning labels for hazardous substances (e.g., over-the-counter drugs, household cleaners).

    • Recent Development: New testing standards were revised in 1995 for child-resistant packaging.

  • Transportation Safety Act of 1974

    • Coverage: Regulates the transportation of hazardous materials and ensures compliance with safety standards.

    • Example: Hazardous Material 181 (HM 181) established global standards for hazardous material transport.

  • National Motor Freight Classification and Uniform Freight Classification

    • Purpose: Outlines standard practices for transporting items via truck and train.

    • Legislation Reference: Rule 41 and Item 222 detail design specifications for shipping packages.

    • Implications: Non-compliance allows for valid damage claims if standards are not met.

Conclusion

  • Course Development

    • Relevant course: "Packaging and Society" (Packaging 368) provides deeper insights into sustainability, environmental issues, and specific regulations governing packaging design and use.