The Food and Drug Administration Regulations

The Food and Drug Administration regulates a wide variety of areas such as food and packaging, drugs and packaging, cosmetics, medical devices and most recently, pet food and packaging. In 1968, the FDA published its first rule on “food additives.”

The FDA regulates adhesives through a number of specific regulations.

Here are just a few: 
• 175.105 Indirect food additives
• 175.125 Pressure sensitive adhesives
• 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.
• 176.180 Components of paper and paperboard in contact with dry foods
• 16 CFR 1500.3(C)(4) for direct skin contact – adhesives for direct use with skin
• 16 CFR 1500.3(C)(2)(i) for oral toxicity – non-toxic adhesives

Below is a brief description of some of the adhesive regulations established by the FDA.

175.105
• Key regulation for FDA-approved adhesives
• Applies to uses below 120°F
• Ingredients must be on the list
• Must have a “functional barrier.”
• Generally accepted that chemicals in these adhesive products will not migrate above the 50 ppb level. Considered a food additive above that level.

 


How Does One Determine FDA Status?

• Start with the product formula and all the raw materials.
• Review the composition of the product such as residual monomer and composition purity.
• Know the intended use of the product.
• Use specific regulations for adjuvants.
• Determine functional barrier issue and exemptions.
• Investigate testing and notification needs.  

Many of our products pass various FDA standards. Some of them are listed below. The regulations in which they pass have been denoted. For more detailed records and third party testing data, please feel free to contact your sales representative or our technical support team.

 

 

 

 

 

fda table

 

 Many of our products meet the requirements for 16 CFR 1500.3(C)(4) for direct skin contact. These include:
•    Covinax 210-00
•    Covinax 222-00
•    Covinax 258-00
•    Covinax 271-00
•    Covinax 271-01
•    Covinax 324-00
•    Covinax 386-07
•    Covinax 525-08
•    Covinax 525-78

Franklin has many adhesives that meet 16 CFR 1500.3(C)(2)(i) for oral toxicity. These include:
•    Covinax 210-00
•    Covinax 222-00
•    Covinax 258-00
•    Covinax 271-00
•    Covinax 324-00
•    Covinax 525-08
•    Covinax 525-78



 

 

 

Sites for more detailed testing information:

  

FDA General Site: 


Everything Added to Food in the United States (EAFUS List)  (over 3000 substances)


Indirect Additives (Packaging) 

http://www.fda.gov/Food/FoodIngredientsPackaging/ucm115333.htm

Chemistry Notification Guidance: