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

Product Image

Distribution date: 29 April 1997 | Final date for Comment: 25 April 2025

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

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)

Product Image

Distribution date: 01 May 1997 | Final date for Comment: 25 April 2025

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)

Dietary Supplements Containing Ephedrine Alkaloids (40 pages)

Product Image

Distribution date: 13 June 1997 | Final date for Comment: 25 April 2025

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

Technical Regulations. RTCR 318:1997. Laboratory for the Analysis of Residues of Chemical and Biological Substances Used in Agriculture for Human and Animal Consumption Regulations (10 pages)

Product Image

Distribution date: 23 June 1997 | Final date for Comment: 25 April 2025

Establish the technical and legal framework regulating everything to do with the analysis of residues in plants and the environment of chemical and biological substances used in agriculture for human and animal consumption. Applicable to the agricultural sector in general, the agricultural chemical and biological substance industry and the public in general.

Products Covered: 07, 0701, 0703, 0704, 0705, 0706, 0707, 0708, 0709, 0710, 0711, 0712, 0713, 0714, 08, 0801, 0802, 0803, 0804, 0805, 0806, 0807, 0808, 0809, 0810, 0811, 0812, 0813, 0814, 09, 0901, 0902, 0903, 0904, 0905, 0906, 0907, 0908, 0910, 10, 11, 1101, 1102, 1103, 1104, 1105, 1106, 1107, 1108, 12, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1208, 1209, 1211, 1212, 1213, 1214, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1519, 1801, 1802, 1803, 1804, 1805, 1806. 19, 1901, 1903, 1904, 20, 2001, 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 21, 2101, 2103, 2302, 2303, 2304, 2305, 2306, 2307, 2308.

Regulation Type: Regular notification

Food safety Animal health Human health Pesticides

Order Amending the Order of 4 August 1986 on the Use of Additives in the Manufacture of Foods for Particular Nutritional Purposes

Product Image

Distribution date: 14 July 1997 | Final date for Comment: 25 April 2025

This draft Order is intended to supplement the Order of 4 August 1986 by authorizing various minerals and vitamins in certain products for particular nutritional uses.

Products Covered: Foods for particular nutritional uses

Regulation Type: Regular notification

Food safety Human health

Draft Amendment to Mexican Official Standard NOM-012-ZOO-1993, Specifications for the Regulation of Chemical, Pharmaceutical, Biological and Food Products for Animal Use or Consumption (3 pages, Spanish)

Product Image

Distribution date: 27 August 1997 | Final date for Comment: 25 April 2025

The reason for this Amendment to the Mexican Official Standard is that the latter does not deal with the "maquiladora" (in-bond export processing) industry: hence the need to include specifications for them since various enterprises of this kind exist. Sections 8.2.2 and 8.2.3 of the Standard therefore have to be amended to avoid confusion.

Products Covered: Chemical, pharmaceutical, biological and food products for animal use and consumption

Regulation Type: Regular notification

Animal feed Animal health Veterinary drugs Feed additives

Draft Amendment to Mexican Official Standard NOM-006-ZOO-1993. Biological Effectiveness Requirements for Ixodicides for Bovine Use and Test Methods (1 page)

Product Image

Distribution date: 30 September 1997 | Final date for Comment: 25 April 2025

This amendment to the Mexican Official Standard has been drawn up because in the present conditions of very high pyrethroid resistance, on the basis of the field evaluations submitted, organophosphates offer an alternative for the control of Haematobia irritans. The draft amendment therefore revises paragraph 4.4 of NOM-006-ZOO-1993 to read as follows:4.4As various fly-killers may have an acaricidal effect and be used for killing ticks, fly-killers must be evaluated at least by field tests carried out by an approved laboratory and have a demonstrated minimum effectiveness of 80 per cent.

Products Covered: Ixodicides for bovine use

Regulation Type: Regular notification

Animal health Veterinary drugs

Draft Mexican Official Standard NOM-055-ZOO-1995, Minimum Requirements for the Preparation of Vaccines Used in the Prevention, Control and Eradication of Avian Influenza (8 pages)

Product Image

Distribution date: 30 September 1997 | Final date for Comment: 25 April 2025

The purpose of this Mexican Official Standard is to standardize the minimum requirements for vaccines, antigens and reagents used in the prevention, control and eradication of avian influenza. It applies to such products whether locally produced or imported.

Products Covered: Vaccines, antigens and reagents

Regulation Type: Regular notification

Animal health Animal diseases Avian Influenza Veterinary drugs Zoonoses

Sanitary Requirements for Importing Animal Blood, Serum and Plasma for Use in Vitro into Chile (2 pages)

Product Image

Distribution date: 06 October 1997 | Final date for Comment: 25 April 2025

Conditions to be met by countries in order to export animal blood, serum and plasma for use in vitro to Chile.

Products Covered: Animal blood, serum and plasma for use in vitro

Regulation Type: Regular notification

Animal health

Food Control Act, 1993 - Draft Regulations (DP-11-1996) B - Raw and Pasteurized Cow's Milk Regulations (22 pages)

Product Image

Distribution date: 29 October 1997 | Final date for Comment: 25 April 2025

The proposed Draft Regulations apply to all raw and/or pasteurized cow's milk produced, manufactured, packaged, labelled, stored, transported, displayed, distributed, sold or traded in Botswana. The Regulations further lay out the provisions concerning: the issuance of permits; inspection of dairy farms and milk plants; sampling procedures; physical, chemical and microbiological requirements for raw and pasteurized milk; plants sanitation facilities and equipment.

Products Covered: Raw and pasteurized cow's milk

Regulation Type: Regular notification

Food safety Human health Bacteria

Submit your email ID to receive notifications about upcoming courses and events