Regulatory Compliance
NOV 14, 2018

Does your packaging supplier understand your regulatory requirements?

Product labels across a broad range of industries are subject to regulatory requirements.  Some fairly straightforward.  Some highly complex.  All subject to change. 

Label compliance is the process of ensuring that a particular product label meets all pertinent regulatory requirements.  Keep in mind that compliance extends beyond government regulation and into industry standards. 

There’s a number of regulatory bodies that oversee many different product categories.  The FDA, for instance, regulates food, beverage, pharmaceutical products and more.  Chemicals, meanwhile, are subject to the EPA regulations and OSHA requirements.  As a result, many bodies dictate what constitutes an acceptable label.  And the standards seem to be constantly changing. 

Below are some regulations that may be applicable to your industry, including but not limited to:

  • BSE/TSE:  Assures the absence of Bovine Spongiform Encephalopathy and Transmissible Spongiform Encephalopathy of which promotes nervous system damage.
  • Commission Regulation (EU) No. 757/2010, Persistent Organic Pollutants (POPs):  Identifies and prevents the use of POPs.
  • CPISA – Consumer Product Safety Improvement Act of 2008:  Protects customers from dangerous products.
  • Proposition 65 – Safe Drinking Water Act and Toxic Enforcement Act of 1986:  Requires state authorities to maintain an up-to-date list of chemicals known to cause cancer or reproductive toxicity.
  • REACH – EU Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation and Authorization of Chemicals:  Obligates suppliers to disclose information with regards to the presence of substances identified on the Candidate List of Substances of Very High Concern (SVHS).
  • Regulation (EC) No, 1272/2008 – Classification, Labeling and Packaging of Substances and Mixtures (CLP):  Assures substances classified as a health risk to be contained and identified appropriately.
  • TPCH – Toxics in Packaging Clearinghouse, Model Toxics in Packaging Legislation (formerly known as CONEG legislation):  Prevents the use of materials containing heavy metals such as mercury, lead, cadmium or hexavalent chromium materials.
  • Washington State’s Children Safe Product Act, Chemicals of High Concern to Children:  Prevents the use of substances which pose a health risk to children.
  • 1990 Clean Air Act/Montreal:  Prevents the use of ozone depleting substances (no class I chlorofluorocarbons (CFCs), halons, or class II hydrochlorofluorocarbons (HCFCs).
  • Miscellaneous Restrictions:  Prohibits the presence of specific chemicals such as Benzophenone, Bisphenol A (BPA), Formaldehyde, Triclosan (TCS), etc.

When evaluating a packaging supplier for new or existing drug products, pharmaceutical manufacturers will mostly likely consult with technical experts who understand the components’ properties.  Because they work in a highly regulated environment, it’s critical that their suppliers also understand that environment.  When a supplier identifies the client’s regulatory drivers, they provide a more effective level of support. 

At Gintzler International, a Resource Label Group Co., we understand the challenges associated with satisfying regulatory bodies and have an experienced, knowledgeable team who has worked with companies in dozens of industries to meet every requirement.  Whether it’s including the right nutrition information to meet FDA compliance, placing EPA-required guidelines on your product or meeting the most stringent pharmaceutical security controls, we’re set up to meet any standard.  We’ll print to the highest principles of ethical labels and provide customized test reports and documentation when required.

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