Dietary Supplements Containing Ephedrine Alkaloids (40 pages)

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Distribution date: 13 June 1997

The Food and Drug Administration (FDA) is proposing to make a finding, which will have the force and effect of law, that a dietary supplement is adulterated if it contains 8 milligrams (8 MG) or more of Ephedrine Alkaloids per serving, or if its labelling suggests or recommends conditions of use that would result in intake of 8 MG or more in a 6-hour period or a total daily intake of 24 MG or more of Ephedrine Alkaloids; require that the label of dietary supplements that contain Ephedrine Alkaloids state "Do not use this product for more than 7 days"; prohibit the use of Ephedrine Alkaloids with ingredients, or with ingredients that contain substances that have a known stimulant effect (e.g., sources of caffeine or yohimbine), which may interact with Ephedrine Alkaloids; prohibit labelling claims that require long-term intake to achieve the purported effect (e.g., weight loss and body building); require a statement in conjunction with claims that encourage short-term excessive intake to enhance the purported effect (e.g., energy) that "taking more than the recommended serving may result in heart attack, stroke, seizure or death"; and require specific warning statements to appear on product labels. FDA is proposing these actions in response to serious illnesses and injuries, including multiple deaths, associated with the use of dietary supplement products that contain Ephedrine Alkaloids and the Agency's investigations and analyses of these illnesses and injuries, FDA is also incorporating by reference its Laboratory Information Bulletin (LIB) No. 4053, that FDA will use in determining the level of Ephedrine Alkaloids in a dietary supplement.

Products Covered: Dietary supplements

Regulation Type: Regular notification

Human health Food safety Labelling

Amendment of the Enforcement Ordinance of the Food Sanitation Law and the Specifications for Food. (Additional establishment of pesticide residue standards) (available in English, 12 pages)

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Distribution date: 01 May 1997

Proposed Maximum Residue Limits for 23 agricultural chemicals

Products Covered: edible vegetable and certain roots and tubers (HS:07), edible fruit and nuts (HS:08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.09, 08.10, 08.11 and 08.12, coffee (HS:09.01), tea (HS:09.02), ginger (HS:0910.10), cereals (HS:10), oil seeds and oleaginous fruits; miscellaneous seeds and fruit (HS:12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10, 1212.91, 1212.92 and 1212.99), cocoa beans (HS:18.01)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Labelling, Packaging and Accompanying Technical Information for Approved Phytopharmaceutical Products (3 pages)

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Distribution date: 29 April 1997

Establishes the labelling, packaging and accompanying technical information requirements for phytopharmaceutical products provisionally authorized for sale or approved (also notified under the TBT Agreement).

Products Covered: Phytopharmaceutical products

Regulation Type: Regular notification

Labelling Packaging Human health Pharmaceutical products

Ban on Use in Agriculture of Active Substances Included in the Composition of Phytopharmaceutical Products (3 pages)

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Distribution date: 29 April 1997

Identification of 66 active substances banned from import into Benin

Products Covered: Phytopharmaceutical products

Regulation Type: Regular notification

Human health Pharmaceutical products

Law 91 664 of 11 February 1991 establishing phytosanitary regulations in the Republic of Benin(12 pages)

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Distribution date: 07 April 1997

Requirements relating to the import/export of plants, plant products and phytosanitary products in the Republic of Benin

Products Covered: -Plant products-Phytopharmaceutical products

Regulation Type: Regular notification

Human health Pharmaceutical products

20th Commission Directive 97/1 (EC) of 10 January 1997 adapting to technical progress Annexes II, III, VI and VII of Council Directive 76/768 (EEC) on the approximation of the laws of the Member States relating to cosmetic products.

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Distribution date: 07 March 1997

Provisional ban on the placing on the market of certain ingredients of bovine, ovine and caprine origin for the manufacturing of cosmetic products.

Products Covered: Cosmetic products as defined in Article 1 of Directive 76/68: any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.

Regulation Type: Regular notification

Human health

Draft Mexican Official Standard NOM-053-ZOO-1995, Minimum Requirements for Vaccines, Antigens and Reagents Used in the Prevention and Control of Foot and Mouth Disease (10 pages)

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Distribution date: 21 November 1996

The purpose of this Mexican Official Standard is to establish the minimum requirements for vaccines, antigens and reagents used in the prevention and control of foot and mouth disease. It applies to all vaccines, antigens and reagents of domestic or foreign origin used in the prevention and control of foot and mouth disease.

Products Covered: Vaccines, antigens and reagents

Regulation Type: Regular notification

Animal health Animal diseases Foot and mouth disease Veterinary drugs

Draft Mexican Official Standard NOM-052-ZOO-1995, Minimum Requirements for Vaccines Used in the Prevention and Control of Newcastle Disease (9 pages)

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Distribution date: 21 November 1996

This Mexican Official Standard is mandatory throughout the national territory. It establishes the minimum requirements for the preparation of vaccines used in the prevention and control of Newcastle disease.

Products Covered: Vaccines

Regulation Type: Regular notification

Animal health Animal diseases Veterinary drugs Newcastle Disease

Proposed Amendments to the Feeds Regulations, Fertilizers Regulations, Health of Animals Regulations and Seeds Regulations (pages 2357-2388)

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Distribution date: 26 September 1996

The new techniques of biotechnology, in particular genetic engineering, are being used to develop new agricultural and food products of benefit to both the Canadian public and other stakeholders in the agriculture and agri-food sector. These amendments have been developed to clarify that the Feeds Act, Fertilizers Act, Health of Animals Act and Seeds Act contain the authority to allow Agriculture and Agri-Food Canada to conduct environmental assessments prior to field releases (or trials) of products under these Acts. These amendments will also clarify for stakeholders in the agriculture and agri-food sector and the public that field releases meet appropriate standards for environmental and human safety and are considered equivalent to standards under the Canadian Environmental Protection Act (CEPA).The amendments to the Seeds Regulations provide regulation of both confined and unconfined releases (releases on an unrestricted basis with no conditions of confinement) into the environment of all plants with novel traits, including forest trees.The amendments to the Feeds Regulations will apply to all novel feeds (feeds that are not listed in regulatory schedules IV or V of the Feeds Regulations or are not substantially equivalent to feeds used presently in Canada) intended for livestock that are released outside of contained facilities.

Products Covered: Biotechnology

Regulation Type: Regular notification

Animal health Human health Biotechnology Genetically modified organisms (GMOs) Plant health

STN 75 5201 - Water Supply Branch. Design of Drinking Water Treatment Plants (in Slovak language, 34 pages)

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Distribution date: 26 September 1996

This standard is aimed at designing new, and reconstructing existing drinking water treatment plants. Water treatment technology, equipment, chemicals and operation materials destined for drinking water treatment plants have to comply with hygienic and technical requirements. Obligatory articles 2.1, 2.2, 2.5, 4.1.4, 4.2.1, 4.2.3, 4.2.4, 4.2.6, 5.1.3, 5.1.4, 5.1.6, 5.4.9, 5.4.13, 5.4.21, 6.2.8, 6.3.8, state obligatory requirements dealing mainly with materials that are in contact with unpurified and drinking water (tanks and pipes coatings), equipment and chemical substances used for disinfection, flocculation, water hardness modification, fluoridation, operation materials used as filter fillings, as well as equipment causing noise and vibrations (pumps, blowers, fans, mixing devices in chemical production, etc.)

Products Covered: Water treatment plants

Regulation Type: Regular notification

Food safety Human health Pests Plant health

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