FDA 21 CFR 175.300 PDF

that addresses “Resinous and polymeric coatings,” found at 21 C.F.R. § FDA’s food additive regulations generally provide generic clearances for. Compliance testing of food contact materials EU FDA. FDA testing Coatings on metal. Coatings on metal 21 CFR (d) table 1—types of food. 16 Jul The U.S. Code of Federal Regulations (21CFR) Part clears coatings for metal substrates and for any suitable substrate that is intended.

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Home Ask An Attorney. Some limitations may apply for the use of residual content present of the some ingredients. Title 49 – Transportation. Title 32 – National Defense. Parts – Reserved.

21 CFR – Resinous and polymeric coatings.

This being the case, the use of pre-reacted components in the manufacture of coatings that would otherwise be produced during the manufacture of ffda finished coating also is permitted since this regulation is generic in nature i. Title 13 – Business Credit and Assistance. In most cases no additional testing is required.

On the other hand, cr defoamer listed under Section In addition to reactants, solvents frequently are used in the manufacture of coatings.

Parts – In response to FDA’s survey, members fca the Can Manufacturers Institute provided the agency with an omnibus petition containing a list of common materials used in can coatings. Title 39 – Postal Service.


If the final product consist of mixtures of polymers blends each polymer type must met its own section. Title 28 – Judicial Administration.

Title 25 – Indians.

FDA Food Grade 21 CFR 175.300

Furthermore, at the time the can 17.5300 regulation was promulgated, FDA imposed a 50 parts per million ppm limit on the overall migration of non-volatiles from the coating to food i. One way to determine whether the solvent will volatilize away is to compare the solvent’s boiling point to the coating’s curing temperature.

Nonacid, aqueous products; may contain salt or sugar or both pH above 5. Toc – Table Of Contents.

Sometimes testing is described for the residual content of a monomer for example styrene or acrylonitril or the solubility of the polymer is mentioned nylon for example. Containing more than 8 percent alcohol. Title 21 of the Code of Federal Regulations C. This requirement flows from Section of the Act, which states that a food is adulterated if it contains fea added substance that may render the food injurious to health vfr otherwise causes the food to be unfit for consumption.

Please Explain FDA Coatings Regulations |

This includes, as discussed above, the 0. To fully comply with the Act, the substance must be of suitable purity for its intended use. Title 1 – General Provisions.


They would not on that basis be permitted for use in coatings. Title 44 – Emergency Management and Assistance. As discussed above, however, it is necessary to establish that use of a solvent or any other food-contact material or component complies with FDA’s GMP requirements in that the finished product is suitably pure for its intended use.

Toc – Table Of Contents Parts – Title 9 – Animals and Animal Products. Shortly after the Food Additives Amendment of fdaa added to the Federal Food, Drug, and Cosmetic Act “the Act”FDA surveyed industry to compile a list of substances that were being used to manufacture can coatings.

Please Explain FDA Coatings Regulations

Thus, an explicit listing under Section Title 36 – Parks, Forests, and Public Property. Accordingly, reaction products of substances listed in the coatings regulation are covered by the regulation for use in the coatings, provided the reaction products can properly be attributed to one of the permitted curing processes for the finished coating. For more information or to change your preferences, click here.

What’s Under the Coat of Section The text below is a short description.