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(iii) Acrylonitrile/butadiene copolymer blended with polyvinyl chloride resin-for use only as extruded pipe.

(b) Limitations for acrylonitrile monomer extraction for finished foodcontact articles, determined by using the method of analysis titled "GasSolid Chromatographic Procedure for Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers and Food-Simulating Solvents," which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408, are as follows:

(1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food-contact surface-0.003 milligram/ square inch when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use.

(2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food-contact surface-0.3 part per million calculated on the basis of the volume of the container when extracted to equilibrium at 120 °F with food-simulating solvents appropriate to the intended conditions of use.

(3) In the case of repeated-use articles-0.003 milligram/square inch when extracted at a time equivalent to initial batch usage utilizing food-simulating solvents and temperatures appropriate to the intended conditions of

use.

The food-simulating solvents shall include, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either nheptane or an appropriate oil or fat.

(c) Acrylonitrile monomer may present a hazard to health when ingested. Accordingly, any food-contact

article containing acrylonitrile copolymers or resins that yield acrylonitrile monomer in excess of that amount provided for in paragraph (b) of this section shall be deemed to be adulterated in violation of section 402 of the Act.

[42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989]

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182.1 Substances that are generally recognized as safe.

182.10 Spices and other natural seasonings and flavorings.

182.20 Essential oils, oleoresins (solventfree), and natural extractives (including distillates).

182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.

182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.

182.60 Synthetic flavoring substances and adjuvants.

182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging.

182.90 Substances migrating to food from paper and paperboard products.

182.99 Adjuvants for pesticide chemicals.

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Subpart 1-Nutrients

Ascorbic acid.

Biotin.

Calcium phosphate.

182.8223 Calcium pyrophosphate.

182.8250 Choline bitartrate.

182.8252 Choline chloride.

182.8778 Sodium phosphate.
182.8890 Tocopherols.

182.8892 a-Tocopherol acetate.
182.8985 Zinc chloride.
182.8988 Zinc gluconate.

182.8991 Zinc oxide.

182.8994 Zinc stearate. 182.8997

Zinc sulfate.

AUTHORITY: 21 U.S.C. 321, 342, 348, 371.

SOURCE: 42 FR 14640, Mar. 15, 1977, unless otherwise noted.

Subpart A-General Provisions

§ 182.1 Substances that are generally recognized as safe.

(a) It is impracticable to list all substances that are generally recognized as safe for their intended use. However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar, baking powder, and monosodium glutamate as safe for their intended use. This part includes additional substances that, when used for the purposes indicated, in accordance with good manufacturing practice, are regarded by the Commissioner generaly recognized as safe for such

uses.

as

(b) For the purposes of this section, good manufacturing practice shall be defined to include the following restrictions:

(1) The quantity of a substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional, or other technical effect in food; and

(2) The quantity of a substance that becomes a component of food as a result of its use in the manufacturing, processing, or packaging of food, and which is not intended to accomplish any physical or other technical effect in the food itself, shall be reduced to the extent reasonably possible.

(3) The substance is of appropriate food grade and is prepared and handled as a food ingredient. Upon request the Commissioner will offer an opinion, based on specifications and intended use, as to whether or not a particular grade or lot of the substance is of suitable purity for use in food and would generally be regarded as safe for the purpose intended, by experts qualified to evaluate its safety.

(c) The inclusion of substances in the list of nutrients does not constitute a finding on the part of the Department that the substance is useful as a supplement to the diet for humans.

Common name

Alfalfa herb and seed

(d) Substances that are generally recognized as safe for their intended use within the meaning of section 409 of the act are listed in this part. When the status of a substance has been reevaluated, it will be deleted from this part, and will be issued as a new regulation under the appropriate part, e.g., "affirmed as GRAS" under part 184 or 186 of this chapter; "food additive regulation" under parts 170 through 180 of this chapter; "interim food additive regulation" under part 180 of this chapter; or "prohibited from use in food" under part 189 of this chapter.

[42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988]

§ 182.10 Spices and other natural seasonings and flavorings.

Spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Botanical name of plant source

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Medicago sativa L.

Pimenta officinalis Lindl.

Hibiscus abelmoschus L.

Angelica archangelica L. or other spp. of Angelica.

Do.

Do.

Galipea officinalis Hancock.

Pimpinella anisum L.

Illicium verum Hook. f.

Melissa officinalis L.

Ocimum minimum L.

Ocimum basilicum L.

Laurus nobilis L.

Calendula officinalis L.

Anthemis nobilis L.

Matricaria chamomilla L.

Capparis spinosa L.

Capsicum frutescens L. or Capsicum annuum L. Carum carvi L.

Nigella sativa L.

Elettaria cardamomum Maton.

Cinnamomum cassia Blume.

Cinnamomum burmanni Blume.

Cinnamomum loureirii Nees.

Capsicum frutescens L. or Capsicum annuum L. Apium graveolens L.

Anthriscus cerefolium (L.) Hoffm.

Allium schoenoprasum L.

Cinnamomum zeylanicum Nees.

Cinnamomum cassia Blume.

Cinnamomum loureirii Nees.

Salvia sclarea L.

Trifolium spp.

Coriandrum sativum L.

Cuminum cyminum L.

Nigella sativa L.

Sambucus canadensis L.

Foeniculum vulgare Mill.

Foeniculum vulgare Mill. var. duice (DC.) Alex.

Trigonella foenum-graecum L.

Alpinia officinarum Hance.

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[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

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