Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle (10 pages, in English)

Distribution date: 19 July 2004 | Final date for Comment: 20 April 2025
The Food and Drug Administration (FDA) is proposing to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics,'' published in this issue of the Federal Register. FDA is proposing recordkeeping requirements because records documenting the absence of prohibited cattle materials are needed by manufacturers and processors of human food and cosmetics that contain cattle material to ensure that these products do not contain prohibited cattle materials. In addition, such records are necessary to help FDA ensure compliance with the requirements of the interim final rule.
Products Covered: Cosmetics and Human Food (HS Chapters 33 and 2106) (ICS 67.020 and 71.100)
Regulation Type: Regular notification
Draft Notification of the Ministry of Public Health on Herbal Tea Standard Requirement. (3 pages in Thai)

Distribution date: 20 July 2004 | Final date for Comment: 20 April 2025
The MOPH deems it necessary to set the standard for herbal tea to protect the consumers as the herbs are currently very popular products for consumption as drinking tea. The above plants used as raw material for herbal tea are required to meet the standard of humidity as announced by MOPH about herbal drugs, or not more than 10 per cent of its weight, no pathogen or toxin from microbe, chemical pesticide, additives and others which will cause the risk to consumers. The manufacturing methods and tools, storage, containers and labelling should also comply with the relevant regulations.
Products Covered: Aegle marmelos (Linn.) Corr., Hibiscus sabdariffa (Linn.), Zingiber officinale Roscoe, Alpinia galanga (Linn.) Stwartz, Cymbopogon citratus Stapf, Morus alba (Linn.), Carthamus tinctorius (Linn.), Centella asiatica (Linn.) Urban, Pandanus odorus Ridl., Chrysanthemum spp. and Hybrid, Momordica grosvenori, Ganoderma lucidum, Phyllanthus emblica (Linn.), Gynostemma pentaphyllum, Derris scandens Benth (ICS 37.140.10)
Regulation Type: Regular notification
Draft Notification of the Ministry of Public Health on Herbal Tea Standard Requirement. (3 pages in Thai)

Distribution date: 20 July 2004 | Final date for Comment: 20 April 2025
The MOPH deems it necessary to set the standard for herbal tea to protect the consumers as the herbs are currently very popular products for consumption as drinking tea. The above plants used as raw material for herbal tea are required to meet the standard of humidity as announced by MOPH about herbal drugs, or not more than 10 per cent of its weight, no pathogen or toxin from microbe, chemical pesticide, additives and others which will cause the risk to consumers. The manufacturing methods and tools, storage, containers and labelling should also comply with the relevant regulations.
Products Covered: Aegle marmelos (Linn.) Corr., Hibiscus sabdariffa (Linn.), Zingiber officinale Roscoe, Alpinia galanga (Linn.) Stwartz, Cymbopogon citratus Stapf, Morus alba (Linn.), Carthamus tinctorius (Linn.), Centella asiatica (Linn.) Urban, Pandanus odorus Ridl., Chrysanthemum spp. and Hybrid, Momordica grosvenori, Ganoderma lucidum, Phyllanthus emblica (Linn.), Gynostemma pentaphyllum, Derris scandens Benth (ICS 37.140.10)
Regulation Type: Regular notification
Interim Marketing Authorization regarding the use of microcrystalline cellulose as a bodying and texturizing agent in breath freshening strips (available in English and French; pages 1953-1954).

Distribution date: 26 July 2004 | Final date for Comment: 20 April 2025
Provision currently exists in the Food and Drug Regulations for the use of microcrystalline cellulose as a bodying and texturizing agent in a variety of foods. Health Canada has received a submission to permit the use of microcrystalline cellulose as a bodying and texturizing agent in breath freshening strips at a maximum level of use of nine percent. Evaluation of available data supports the effectiveness and safety of this new use for microcrystalline cellulose. Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the optional use of microcrystalline cellulose as a bodying and texturizing agent in the manufacture of breath freshening strips at a maximum level of use of nine percent. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization (IMA) is being issued to permit the immediate use of microcrystalline cellulose, as indicated above, while the regulatory process is undertaken to formally amend the Regulations. A revision to this notification will be published at the start of the amendment process and Members will be given the opportunity at that time to submit comments on this proposed measure
Products Covered: Microcrystalline cellulose (ICS: 67.180.20)
Regulation Type: Regular notification
Proposed Changes to the Dietary Supplements Regulations 1985. Part two: Sections 4, 5,6 (available in English).

Distribution date: 26 July 2004 | Final date for Comment: 20 April 2025
Proposal 1 Amend the Dietary Supplements Regulations 1985 to permit a maximum daily dose of 500mcg of folic acid in a dietary supplement. Proposal 2 Amend the Dietary Supplement Regulations to permit the following sweeteners currently permitted under the Food Standards Code Saccharin or its calcium or ammonium or sodium salt Cyclamate (cyclohexysulphamic acid or its sodium or calcium salt) Aspartame Acesulphame potassium Thaumatin Sucralose Alitame Neotame Proposal 3 Amend the Dietary Supplement Regulations 1985 to include the following labelling provisions currently mandated for food under the Australia New Zealand Food Standards Code: Clause 4 of Standard 1.2.3 [Mandatory Warning and Advisory Statements and Declarations] which provides for the mandatory declaration of substances identified as having potential to cause severe adverse reaction; and Clause 2 of Standard 1.2.9 [Legibility Requirements], which requires food labelling to be written in the English language.
Products Covered: Proposal 1 Folic Acid Supplements Proposal 2 Artificial Sweeteners Proposal 3 Cereals containing gluten and their products, wheat, rye, barley, oats and spelt Crustacea and their products Eggs and egg products Fish and fish products Milk and mild products 789 Peanuts and soybeans, and their products Added sulphites in concentrations of 10 mg/kg or more Tree nuts and sesame seeds and their products.
Regulation Type: Regular notification
Proposed Changes to the Dietary Supplements Regulations 1985. Part two: Sections 4, 5,6 (available in English).

Distribution date: 26 July 2004 | Final date for Comment: 20 April 2025
Proposal 1 Amend the Dietary Supplements Regulations 1985 to permit a maximum daily dose of 500mcg of folic acid in a dietary supplement. Proposal 2 Amend the Dietary Supplement Regulations to permit the following sweeteners currently permitted under the Food Standards Code Saccharin or its calcium or ammonium or sodium salt Cyclamate (cyclohexysulphamic acid or its sodium or calcium salt) Aspartame Acesulphame potassium Thaumatin Sucralose Alitame Neotame Proposal 3 Amend the Dietary Supplement Regulations 1985 to include the following labelling provisions currently mandated for food under the Australia New Zealand Food Standards Code: Clause 4 of Standard 1.2.3 [Mandatory Warning and Advisory Statements and Declarations] which provides for the mandatory declaration of substances identified as having potential to cause severe adverse reaction; and Clause 2 of Standard 1.2.9 [Legibility Requirements], which requires food labelling to be written in the English language.
Products Covered: Proposal 1 Folic Acid Supplements Proposal 2 Artificial Sweeteners Proposal 3 Cereals containing gluten and their products, wheat, rye, barley, oats and spelt Crustacea and their products Eggs and egg products Fish and fish products Milk and mild products 789 Peanuts and soybeans, and their products Added sulphites in concentrations of 10 mg/kg or more Tree nuts and sesame seeds and their products.
Regulation Type: Regular notification
TIS 15: Part 12532(1989) Portland Cement: Part 1 Specification (7 pages, available in English)

Distribution date: 03 August 2004 | Final date for Comment: 20 April 2025
The Thai Industrial Standards Institute (TISI) has proposed to enforce TIS 15: Part 1-2532(1989) as a mandatory standard. The standard classifies Portland cement into 5 types. Specifies chemical properties (e.g. aluminium oxide, loss on ignition, insoluble residue) and physical properties (e.g. air content of mortar, fineness, time of setting, etc.). Includes packaging, marking and labelling, sampling and criteria for conformity and testing.
Products Covered: Cement, Gypsum, Lime. Mortar (HS Chapter 2523, ICS: 91.100.10)
Regulation Type: Regular notification
TIS 15: Part 12532(1989) Portland Cement: Part 1 Specification (7 pages, available in English)

Distribution date: 03 August 2004 | Final date for Comment: 20 April 2025
The Thai Industrial Standards Institute (TISI) has proposed to enforce TIS 15: Part 1-2532(1989) as a mandatory standard. The standard classifies Portland cement into 5 types. Specifies chemical properties (e.g. aluminium oxide, loss on ignition, insoluble residue) and physical properties (e.g. air content of mortar, fineness, time of setting, etc.). Includes packaging, marking and labelling, sampling and criteria for conformity and testing.
Products Covered: Cement, Gypsum, Lime. Mortar (HS Chapter 2523, ICS: 91.100.10)
Regulation Type: Regular notification
Assessment Reports for Maximum Residue Limits Application A539 (26 pages in English).

Distribution date: 04 August 2004 | Final date for Comment: 20 April 2025
This Application seeks to amend the Australia New Zealand Food Standards Code (the Code) to align maximum residue limits (MRLs) for the antibiotic avilamycin in pig commodities so that they are consistent with other national regulations relating to the safe and effective use of agricultural and veterinary chemicals. In administrative terms and consistent with international practice, MRLs assist in regulating the use of agricultural and veterinary chemical products. MRLs indicate whether agricultural and veterinary chemical products have been used in accordance with the registered conditions of use. MRLs in the Code also act to protect public health and public safety by ensuring that chemical residues are no higher than necessary, and act as international trading standards. The MRLs prescribed in the Code constitute a mandatory requirement applying to all food products of a particular class, whether produced domestically or imported. Food products with a residue that exceeds the relevant MRL set out in the Code cannot legally be supplied or sold in Australia. This Application contains variations to MRLs, which are not addressed in the Codex Alimentarius Commission standard. These MRLs may also relate to chemicals used in the production of heavily traded agricultural commodities, which may indirectly affect trade of derivative food products between WTO Members.
Products Covered: Foods in general.
Regulation Type: Regular notification
Assessment Reports for Maximum Residue Limits Application A539 (26 pages in English).

Distribution date: 04 August 2004 | Final date for Comment: 20 April 2025
This Application seeks to amend the Australia New Zealand Food Standards Code (the Code) to align maximum residue limits (MRLs) for the antibiotic avilamycin in pig commodities so that they are consistent with other national regulations relating to the safe and effective use of agricultural and veterinary chemicals. In administrative terms and consistent with international practice, MRLs assist in regulating the use of agricultural and veterinary chemical products. MRLs indicate whether agricultural and veterinary chemical products have been used in accordance with the registered conditions of use. MRLs in the Code also act to protect public health and public safety by ensuring that chemical residues are no higher than necessary, and act as international trading standards. The MRLs prescribed in the Code constitute a mandatory requirement applying to all food products of a particular class, whether produced domestically or imported. Food products with a residue that exceeds the relevant MRL set out in the Code cannot legally be supplied or sold in Australia. This Application contains variations to MRLs, which are not addressed in the Codex Alimentarius Commission standard. These MRLs may also relate to chemicals used in the production of heavily traded agricultural commodities, which may indirectly affect trade of derivative food products between WTO Members.
Products Covered: Foods in general.
Regulation Type: Regular notification
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