Im familiar with the 7-22mm hard plastic rule regarding choking and injury but is the any guidance on soft, flexible plastic resin?
Is product considered adulterated with small amount of plastic resin
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Posted 26 September 2018 - 06:13 PM
I think the FDA may feel this scenario would fall under #4 below...........
The following is an example of a state statute defining adulterated food:
"(a) Food is adulterated if
- it bears or contains a poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance the food is not considered adulterated under this paragraph if the quantity of the substance does not ordinarily render it injurious to health;
- it bears or contains added poisonous or added deleterious substance which is unsafe within the meaning of ...
- it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;
- it has been produced, prepared, packed, or held under unsanitary conditions in which it may have become contaminated with filth, or in which it may have been rendered diseased, unwholesome, or injurious to health;
- it is, in whole or in part, the product of a diseased animal or an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse;
- its container is composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
(b) Food is adulterated if
- a valuable constituent has been omitted or abstracted in whole or part;
- a substance has been substituted in whole or part for a valuable constituent;
- damage or inferiority has been concealed;
- a substance has been added or mixed or packed with it to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
© Confectionery is adulterated if it bears or contains an alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one per cent, harmless natural wax not in excess of four-tenths of one per cent, harmless natural gum, and pectin. This subsection does not apply to confectionery containing less than one-half of one per cent by volume of alcohol derived solely from the use of flavoring extracts, or to chewing gum containing harmless nonnutritive masticatory substances.
(d) Food is adulterated if it bears or contains a coal tar color other than one from a batch which has been certified under authority of the federal act."
Please stop referring to me as Sir/sirs
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Posted 26 September 2018 - 08:54 PM
Found a few things. First the FDA has information on substance levels of other products in food that are not found to be harmful. It appears that they have a list of them but you may need to requewst a current list from the Center for Food Safety and Applied Nutrition.
Subpart G Defect Action Levels
Sec. 110.110 Natural or unavoidable defects in food for human use that present no health hazard.
(a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoidable defects that at low levels are not hazardous to health. The Food and Drug Administration establishes maximum levels for these defects in foods produced under current good manufacturing practice and uses these levels in deciding whether to recommend regulatory action.
(b) Defect action levels are established for foods whenever it is necessary and feasible to do so. These levels are subject to change upon the development of new technology or the availability of new information.
© Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and holders shall observe current good manufacturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable defects are lower than the currently established defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible.
(d) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food.
(e) A compilation of the current defect action levels for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition
(HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. [51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
I also found a neat powerpoint that may or may not help you when it comes to plastics and some of the hazards with their use during manufacturing and production.
Vice President and SQF Practitioner in Pennsylvania
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