PKSC ACTUAL laws and regulations
PKSC ACTUAL laws and regulations 81499 - PKSC 1020 - 001
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81499 - PKSC 1020 - 001
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This 3 page Class Notes was uploaded by Addie Pearson on Tuesday April 12, 2016. The Class Notes belongs to 81499 - PKSC 1020 - 001 at Clemson University taught by Heather P Batt in Fall 2015. Since its upload, it has received 19 views. For similar materials see Introduction to Packaging Science in Nutrition and Food Sciences at Clemson University.
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Date Created: 04/12/16
PACKAGING LAWS AND REGLATIONS CRFs- code of federal regulations where you go to find the details of the laws SoP- Standards of practice- now always laws but can be upheld in court of law and law suit cases FIRST LAWS: INDIRECTLY PKG RELATED - Food and drug law: 1906 o To protect consumer o Fight against fraud FOOD DRUG AND COSMETIC ACT- 1938 - Banned poisonous substances used in foods and tried to address “over packaging” - Important landmark but not very effective FOOD ADDITIVES AMENDMENT – 1958 - First law that directly affected packaging - Anything that directly or indirectly becomes part of the food is considered an additive- INCLUDES PACKAGING COMPONENTS FIVE MAJOR PROVISIONS - Food additives defined (anything that comes in contact with the food) - Burden of prof shifted to industry - “the Delaney Clause”- outlaws carcinogenic additives - Established “GRAS” additives (Generally Recognized As Safe) - Established GMp’s (Good Manufacturing Practices) FOUR CATIGORIES OF SUBSTANCES THAT ARE NOT “FOOD ADDITIVES” AND NOT SUBJECT TO REGULATION 1. May not reasonably be expected to become a component of the food (like a plastic handle used for support is not expected to become part of the food it is holding) 2. Are GRAS 3. Are prior sanctioned 4. Are regulated – passes a series of testS EXAMPLE: Black polyethylene – color provided by carbon black, a CARCINOGEN - Can you use this as a food package? - Answer: YES as long as it is on the OUTSIDE LAYER with a foil barrier Can prior sanction list get bigger? - Answer: no, only things used prior to 1958 are on that list Can things be removed fro the prior sanction list? - Yes, newer analysis methods can prove something harmful that was previously accepted as safe What do you do if you have developed a NEW POLYMER? - Test with rat studies (able to test the life span of a rat) - File a food additives petition with FDA - FDA approves or disapproves - If approves, add it to list of acceptable materials FAIR PACKAGING AND LABELING ACT- 1966 - Nutritional label required - Ingredients listed in DESCENDING order of prominence - Name and address of company and/or distributor - Detailed format of quantity declaration o Ex) must appear at lower 30% of PDP (Principle Display Panel) NUTRITION LABELING AND EDUCATION ACT – 1990 - Revised 1966 requirements - Specifies label format - Established new diet standards - Defined declaration statements such as “low fat” “reduced cancer” “lite” “reduces heart disease” etc…. - Does not include diet supplements, YET OTHER SIGNIFICANT PACKAGING LAWS - Poison Prevention Act – 1970 o Significant deaths related to accidental poisonings o Included aspirin, vitamins, furniture polish o Lead to child resistance packaging and warning labels o Recently revised with new testing standards in 1995 - Tamper Evident Act – 1982 o Seven deaths in tylenol-cyanide poisoning incident o Tamper evident – not “proof” or “resistant” o Required for Over The Counter (OTC) pharmaceuticals only DISTRIBUTION LAWS AND REGULATIONS - Dept of transportation regulating body - Transportation safety act of 1974 o Covers hazardous materials o 1990- HM181 adopts global standards - National motor classification and uniform freight classification (rail) specify standard practices o Ex) rule 41, Item 222 specifies design, style, and materials etc. for shipping packages if damage or injury occurs when standards aren’t followed, damage claims are valid
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