Repeat-use articles

For repeat-use articles, FDA takes into account information on the uses of articles that may contain the FCS such as the weight of food contacting a known area of a representative repeat-use article, contact time of food with the repeat-use article, and the average lifetime of the article. This allows the calculation of a representative food mass-to-surface area ratio for the use and extrapolation of the representative migrant levels in food over the entire service lifetime of the article. In general, exposure estimates for repeat-use applications are lower than those for single-use, primarily because of the large food mass-to-surface area ratio used in the calculations. 

In handling EP(D)M, normal industrial hygienic procedures should be followed. It is advisable to minimi2e skin contact. The use of EP(D)M is permitted for food contact under the conditions given in the respective EDA-paragraphs 177.1520 for Olefin polymers, and 177.2600 for mbber articles intended for repeated use. 

Evaluation of Results. At least two independent assays are carried out for each test article. The criterion for positive response is a reproducible and statistically significant result at any concentration for any strain. When positive results are obtained, the test is repeated, using the strain(s) and concentration range with which the initial positive results were observed. This range may be quite narrow for toxic agents. 

Coumarone-indene resin as a plasticizer in rubber articles intended for repeated use in contact vith food Yes CFR 1989d (21 CFR 177.2600)... 

Table I is a list of all the enzymes that will be mentioned in this article. Neither the E.C. number nor the nomenclature name is convenient for repeated use in a discussion. Therefore, for the running text, we shall use mostly the time-established trivial names. We shall use 1 to 3-letter symbols in the Tables. For these, we have followed common practice as much as possible, but we had to innovate in some cases in order to avoid confusion.

Section 177.2600—Rubber Articles Intended for Repeated Use (The primary section containing a list of materials used in rubber formulations for pharmaceutical items.)... 

FDA approved for food contact. Approved under 21CFR175.105 - adhesives (no limitations), 175.125 - pressure sensitive adhesives (0.1% max.) and 177.2600 - rubber articles intended for repeated use (5% max.). 

FDA approved for food contact under 21CFR177.2600 - rubber articles intended for repeat uses, not to exceed 5% by weight of the total composition and 21CFR178.3570 - lubricants with incidental food contact not to exceed 1% by weight of the total composition. 

FDA approval under 21CFR177.2600 - Rubber Articles Intended for Repeated Use - Limitation - 5% Max. 

FDA approved under 21CFR175.300 - Resinous and Polymeric Coatings, limited to can end cement, 177.1210 - Closures with Sealing Gaskets for Food Containers (limitation - 2% Max.), and 177.2600 - Rubber Articles Intended for Repeated Use, (limitation - 5% Max.). 

Beilstein Handbook Reference) Antage Crystal Antioxidant AO Antioxidant TMB 6 Bis(3-tert-butyl-4-hydroxy-6-methylphenyl) sulfide BRN 1147776 CCRIS 4917 Disperse MB-61 EINECS 202-525-2 HSDB 5304 Nocrac 300 Nonflex BPS NSC 35388 Rutenol Santonox Santonox BM Santonox R Santowhite crystals Santox Sumilizer WX Sumilizer WX-R Thioalkofen BM 4 Thioalkofen BMCH Thioalkofen MBCH Thioalko-phene BM-4 Ultranox 236 USAF B-15 Yoshinox S Yoshinox SR, Antioxidant for use in adhesives, rubber articles for repeated use, polymers include polyolefins, PVC, xrylic ethyl cellulose antioxidant for lubricants, cutting oils, water-sol. oils, hydraulic oils. Solid mp = 161-164° insoluble in H2O. GE Silicones. 

Indirect food additives—rubber articles intended for repeated use... 

FDA. 2000c. Indirect food additives Polymers Substances for use only as components of articles intended for repeated use Rubber articles intended for repeated use. Food and Drug Administration. Code of Federal Regulations. 21 CFR 177.2600. 

Fluoroelastomers have been approved by the U.S. Food and Drug Administration for use in repeated contact with food products. More details are available in the Federal Register, Vol. 33, No. 5, Tuesday January 9, 1968, Part 121—Food Additives, Subpart F—Food Additives Resulting from Contact with Containers or Equipment and Food Additives Otherwise Affecting Food—Rubber Articles Intended for Repeated Use. 

Uses Pigment, opacifier for latexes, and in food-contact adhesives, res-inous/polymeric coatings, paper/paperboard, rubber articles for repeated use, and polymers... 

Uses Antioxidant, preservative for foods, pharmaceuticals, animal feed, petroleum prods., jet fuels, lubricants, solvents, hot-melt adhesives, syn. rubbers, plastics (polyamide, polyolefins, POM, PU, PVC, PS), soaps antioxidant for fats, oils, soap antiskinning agent in paints and inks oxidation/gum inhibitor in gasoline antioxidant in fo -contact coatings, food-pkg. adhesives and pressure-sensitive adhesives defoamer in food-contact paper/paperboard antioxidant in food-contact mbber articles for repeated use in lubricants for incidental food-con-tact use... 

Uses Antioxidant for rubber and latexes. NR. synthetics, cellulosics. EVA, polyamide, polyesters, polyolefins, PVC, PU, PS polymer stabilizer in food-pkg. adhesives can end cement for food contact finish component for poly (phenyleneterephthalamide) food-pkg. resins antioxidant in food-contact rubber articles for repeated use antioxidant/sta-bilizer for food-grade polymers... 

Uses Rubber used In 0-rlngs, oil and shaft seals, gaskets, hose, diaphragms, mech. goods, propellants, fiber optic components, elec, coatings, food-contact articles for repeated use Regulatory FDA 21CFR 177.2600 Trade Names Kel-F Brand 800 Resin... 

Uses Antioxidant for rubber goods esp. latex applies., polyamides, polyesters, POM, PVC, PS, EVA hot melts, thermoplastic rubber, styrenics, cellulosics in food-pkg. adhesives antioxidant in food-contact rubber articles for repeated use antioxidant/stabilizer for food-grade polymers Regulatory FDA21CFR 175.105,177,2600,178,2010 Manuf/Distrib. Goodyear R.T. Vanderbilt Trade Names Ralox LC... 

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