21 CFR (Code of Federal Regulations) of the FDA

General informations

The food contact compliance of a paper/board material with FDA regulation 21 CFR is assessed on the basis of positive lists which are specific to this regulation and differ from those used in Europe.

The composition check is a key stage of this assessment. The CTP’s experts will assist you and place the centre’s three laboratories dedicated to chemical, sensory and microbial analyses at your disposal. These human and material resources work for a complete and independent expertise.

The CTP can also organise Food Contact training courses, provide technical assistance and help you regarding Good Manufacturing Practices (GMP).

 
Technical Data and Achievements

Code of Federal Regulations
The Code of Federal Regulations (CFR) contains the federal rules in force in the United States. It is divided into 50 different titles covering subject areas such as agriculture, banking and aeronautics. The title that concerns paper/board materials is title 21, Food and Drugs.
Each title is then broken down into chapters called after the agency in charge of its application and control. Papers and boards enter the scope of chapter I ‘Food and Drug Administration (FDA), Department of Health and Human Services’ subchapter B ‘Food for Human Consumption’.
More precisely, the part 176 is dedicated to Indirect Food Additives: Paper and Paperboard Components. Two different sections within this part cover the foreseeable conditions of contact.

Paragraphs 176.170 et 176.180
§176.170 concerns materials intended to come into contact with aqueous, acidic, alcoholic and fatty foodstuff, while§176.180 concerns dry foodstuff only.
Both have a positive list of substances allowed into the material composition. This content may vary from one section to the other.

Crossed references
§176.170 and §176.180 contain a large number of references to other paragraphs of title 21. Therefore, it is possible to use the related positive lists, considering the restriction.

Other available lists
Alongside §176.170 and 176.180, other lists allow the use of a substance in a paper and board material:
   - Generally Recognized as Safe (GRAS)
   - Prior Sanctioned
   - Threshold of Regulation Exemptions (TOR)
   - Food Contact Notifications (FCN)

Comparison with Europe
any things differ on food contact compliance between Europe and the FDA, here are some (non-exhaustive list):
   - Substances and/or restrictions can be different
   - Distinction between food additives and food contact substances does not exist in FDA
   - Purity criteria are not the same
Please find more details in the training course “Food contact regulations”.

Tree view of 21 CFR for paper and boards materials		Food contact compliance evaluation differs between Europe and United States