Plastic Regulatory Documentation
All levels of government regulations of plastic, especially food grade packaging or plastic in food, have long arms which require documentation of compliance with their alphabet soup of acronyms.
Many plastic film extruders and the FDA do not take these regulations seriously.
At Brentwood Plastics, we must comply with multiple regulations for medical devices which require traceability and lot tracking. For this reason, we have a thorough knowledge of most regulations applicable to flexible plastic films. Substances of very high concern known as SVHC simply are not a component of the feedstocks or catalysts used to make polythene polyethylene plastic. We could not have a record of Kosher approval or approval for medical devices with prolonged direct contact to human skin if these chemicals were ingredients of our products.
Letters specific to compliances are issued only to customers upon request.
Here in alphabetical order is a list of most commonly encountered regulations along with a brief definition plus links for more in-depth information.
Allergens
To claim a product is allergen or sensitizer free without labeling and fully comply with the US FDA Food Allergen Labelling and Consumer Protection Act (FALCPA) and EU directive 2003/89/EC, the finished product must not contain peanuts, tree nuts, milk, eggs, wheat/gluten, fish, shellfish, sulphur dioxide and sulfites, food colors, celery, seeds, natural rubber latex monosodium glutamate (MSG) and aspartame.
BPA free
What is BPA? BPA is short for Bisphenol A which is utilized as a catalyst in the manufacture of epoxy, PVC and polycarbonate resins. Bisphenol A BPA is not a component of polyethylene resins.
California Proposition 65
Safe Drinking Water and Toxic Enforcement Act of 1986, prop 65 was ostensibly enacted to prevent carcinogenic substances from getting into drinking water.Some chemicals listed were used for pigmentation of plastics but they have been mostly phased out in the US.
CAS
Chemical Abstract Services is a generic database of chemicals accumulated for over 100 years.
Each CAS Registry Number (often referred to as a CAS Number):
• Is a unique numeric identifier
• Designates only one substance
• Has no chemical significance
Learn more about a specific chemical substance here.
CFC
CFC is an abbreviation for Chlorinated Fluorocarbons. Concerns about CFC’s have to do with ozone depletion. Not applicable to the manufacture of polyethylene film or polyethylene resins.
CFIA
Canadian Food Inspection Agency (CFIA) approval of films and resin is practically impossible. To comply with their packaging regulations, every variation on a theme must be submitted for approval.
CONEG
The Coalition of Northeast Governors was created in 1976 for economic development of the Northeast states, the scope was widened in 1992 to the TPCH, or Toxics in Packaging Clearinghouse.
FDA
To be an US Food and Drug Administration or FDA approved plastic for prolonged contact with food and food grade packaging, there must be a thread of letters back to the resin manufacturer with specific language regarding compliance with 21 CFR section 177.1520. In practice, this is not enforced.
We do not publish the specific language for FDA approval online for obvious reasons.
GMO Genetically Modified Organism
Polyethylene made from natural gas feedstocks are not made from an organism whose DNA has been modified. To determine whether a bio-based plastic such as polylactic acid (PLA) has been made from GMO corn, check with your supplier.
HMF Heavy Metal Free
To be HMF/Heavy Metal Free, a resin manufacturer must confirm that they do not intentionally add during the polymerization or formulation processes the heavy metals lead, cadmium mercury and hexavalent chromium. The total allowable combined concentration is 100 ppm to comply with CONEG, prop 65 and EU RoHS.
Further assurances must be made that raw materials containing heavy metals such as arsenic, antimony, barium, beryllium, cobalt, nickel, tin or selenium are not used.
Melamine
Melamine is a thermoset plastic, not a thermoplastic polymer. It is used mainly to make dishware.
PFOA
PFOA is an additive used for making non-stick cookware. Not used for making PE plastic film.
Phthalate free
Phthalates were once ubiquitous and used for a variety of applications. As phthalates apply to plastics, they were used as plasticizers to soften polyvinyl chloride, or PVC. Phthalates are not utilized to make polyethylene resins or film.
REACH statement a/k/a RoHS
Short for Registration, Evaluation, Authorization and Restriction of Chemicals required by the European Directive RoHS (1907/2006/EU) which went into effect on December 18, 2006. REACH or RoHS is an example of a regulation with a long reach. Any product manufactured outside the EU and shipped into the EU must comply.
The manufacturer must state that the product is not manufactured with ingredients that would intentionally add lead, cadmium, mercury, hexavalent Chromium, polybrominated biphenyls PBB, Polybrominated diphenyl ethers PBDE, chlorinated paraffin or hexabromocyclodedecane.
Substances of Very High Concern SVCH
Substances of Very High Concern SVCH are ubstances which may have serious and often irreversible effects on humans and the environment. See REACH.
USDA United States Departement of Agriculture
There is no such thing as USDA approved plastic film.