Status of Certain Additional Over-the-Counter Drug Category II Active Ingredients (18 pages, in English).

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Distribution date: 24 June 2008 | Final date for Comment: 24 April 2025

The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. FDA is proposing that any OTC drug product containing any of these ingredients must be the subject of an approved NDA (New Drug Application).

Products Covered: Drug products (HS:  3004, 1302.19) (ICS:  11.120)

Regulation Type: Regular notification

Draft Resolution nº 21, 3 June 2008 – Technical regulation on E11 – etridiazole (2 pages, Portuguese).

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Distribution date: 24 June 2008 | Final date for Comment: 24 April 2025

Products Covered: Insecticides, rodenticides, fungicides, herbicides, disinfectants, etc. (HS:  38.08)

Regulation Type: Regular notification

Normative Instruction N° 34, 28 May 2008

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Distribution date: 26 June 2008 | Final date for Comment: 24 April 2025

The notified regulation approves the Technical Regulation of Sanitary and Technologic Inspection of Animal By-Products Processing and the By-Products Transport Form.

Products Covered: Animal by-products

Regulation Type: Regular notification

Animal health

KS 2040:2008 Specification for calcium chloride (25 Pages, in English).

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Distribution date: 27 June 2008 | Final date for Comment: 24 April 2025

Products Covered: Calcium chloride (HS: 2827.20.00; ICS: 71.00)

Regulation Type: Regular notification

Notification of the Department of Fisheries entitled "A review of the requirements for importation of live carps, Cyprinus carpio, into Thailand for culture purpose dated 21 March 2008"

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Distribution date: 27 June 2008 | Final date for Comment: 24 April 2025

Thailand SPS notification # G/SPS/N/THA/142 entitled "Certificate of origin and health requirements for importation of live carps, Cyprinus carpio, and their gametes into Thailand for culture purpose" shall be repealed and replaced by this emergency notification: According to the current Office International des Epizooties (OIE) Aquatic Manual for koi herpes virus (KHV) diagnosis, Department of Fisheries (DOF) has re-accessed the risk of importation and import requirement for importation of live koi carp or common carp, Cyprinus carpio, into the Kingdom of Thailand. The control regulation for trans-boundary movement of aquatic animal diseases using quarantine measures on imports of koi carp or common carp is as follows: - Pre-importation: facilities of Thai aquatic animal farms or companies have to achieve the quarantine standard of the DOF before receiving an import permit. - Arrival of aquatic animals at the port: the imported animals must be accompanied with Certificate of Origin and Health. The fish will be subjected to quarantine at the certified quarantine areas of the importing farms or companies. - Post-importation: aquatic animals will be quarantined for at least 21 days. Fish health inspectors will examine the animals for diseases listed in the OIE, KHV and Spring viraemia of carp virus (SVCV) and other contagious pathogens. Certificate of Origin and Health shall certify as follows: A health certificate must be presented at the port of entry together with the aquatic animal shipment. The health certificate must be issued by competent authority, signed by veterinarian or authorised officer and contained information as follows: . Name and address of exporter . Name and address of destination/importer . Name (scientific and common name), size and number of imported common carp or koi carp. . Origin of the common carp or koi carp to be exported. . The common carp or koi carp must come from a country, a zone or a farm establishment where they are submitted to a health supervision set up to operate according to the procedures described in the Diagnostic Manual for Aquatic Animal Diseases from OIE and that this country, zone, or farm establishment is recognized officially unaffected by the KHV and SVCV or OIE listed diseases. . The exported animals must not come from the sources that had an unusual mortality, which the causation could not be explained, during the previous 3 months. . Before exportation, the common carp and koi carp must be quarantined for 7-10 days and treated with chemicals to remove all external parasites. . The model Health Certificate for live fish suggested by the OIE that covered the KHV and SVCV certification shall be used.

Products Covered: Live koi fish (color carp or fancy carp) and common carp (Cyprinus carpio)

Regulation Type: Revision to Emergency Notification (SPS)

Animal diseases Animal health

Exhaust Emission Standards for 2012 and Later Model Year Snowmobiles (4 pages, in English)

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Distribution date: 30 June 2008 | Final date for Comment: 24 April 2025

EPA is proposing to remove the oxides of nitrogen (NOX) component from the Phase 3 snowmobile standards set to take effect in 2012, and; clarify the evidence and analysis upon which the Phase 3 carbon monoxide (CO) and hydrocarbon (HC) standards were based.

Products Covered: Snowmobiles (HS:  8703.10) (ICS:  43.160, 13.040, 13.020, 71.100)

Regulation Type: Regular notification

"Portaria" N° 91, 6 June 2008

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Distribution date: 01 July 2008 | Final date for Comment: 13 August 2008

The notified document is a draft released for a 60-day public consultation period that regulates trading of controlled substances and products with controlled substances of veterinary usage under mandatory prescription of veterinarian.

Products Covered: Veterinary products with controlled substances

Regulation Type: Regular notification

Animal health Veterinary drugs

Draft Mexican Official Standard PROY-NOM-244-SSA1-2005, Equipment and germicides for domestic water treatment. Health requirements (16 pages, in Spanish).

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Distribution date: 07 July 2008 | Final date for Comment: 24 April 2025

The notified Mexican Official Standard sets forth health requirements and characteristics in respect of equipment and germicides for domestic water treatment. It is binding throughout Mexican territory for natural and legal persons involved in the processing (i.e. the manufacture, packaging, handling and storage etc.) and importation of the equipment and germicides to which it refers.

Products Covered: Importers of equipment and germicides for domestic water treatment

Regulation Type: Regular notification

Draft Commission Regulation amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I to IV thereto to technical progress (12 pages, in English).

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Distribution date: 09 July 2008 | Final date for Comment: 24 April 2025

Products Covered: Fertilisers (HS: 31)

Regulation Type: Regular notification

SANCO/569/2008 Draft Commission Directive amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners

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Distribution date: 14 July 2008 | Final date for Comment: 12 September 2008

The draft Directive updates the specific purity criteria for . Nisin produced through a modified (sugar) production process, . Alginic acid (and their salts) regarding their content in formaldehyde, . Guar gum (extending the scope to partially depolymerised guar gum), . Magnesium carbonate, . Calcium hydroxide and calcium oxide (regarding their content on Magnesium, alkali salts, and lead), . Beeswax (regarding its content of lead) and . Microcrystalline wax.

Products Covered: Alginic acid (HS 3913), Beeswax (HS1521), Calcium hydroxide and calcium oxide (HS 2825), Guar gum (HS 1302) , Magnesium carbonate (HS 2519), Microcrystalline wax (HS 2712), Nisin (HS 3504), when circulating as food additives. (ICS: 67.220)

Regulation Type: Regular notification

Food safety Human health Food additives

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