Regulatory Updates

Carbofuran; Proposed Tolerance Revocations; Proposed Rule (30 pages, English)

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Distribution date: 07 August 2008

EPA is proposing to revoke all tolerances for carbofuran.

Products Covered: Carbofuran (HS 38.0810:  ICS 71.100, 65.100)

Regulation Type: Regular notification

New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition

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Distribution date: 01 August 2008 | Final date for Comment: 02 September 2008

The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. This order is based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health.

Products Covered: Food producing animals

Regulation Type: Regular notification

Food safety Veterinary drugs Animal health Human health

Bottled Drinking Water (20 pages, in Arabic and 12 pages, in English).

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Distribution date: 01 August 2008

Products Covered: Bottled Drinking Water (HS: 22 01 90 90)

Regulation Type: Regular notification

Food standards

Testing of Certain High Production Volume Chemicals; Second Group of Chemicals; Proposed Rule (30 pages, in English).

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Distribution date: 01 August 2008

EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors of nineteen high production volume (HPV) chemical substances to conduct testing to obtain screening level data for health and environmental effects and chemical fate.

Products Covered: HPV chemicals (HS: 29) (ICS: 19, 71.080)

Regulation Type: Regular notification

Medida sanitaria mediante la cual se establecen los requisitos para los lactosueros en polvo como materia prima de alimentos para consumo humano

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Distribution date: 22 July 2008

La República de Colombia comunica con relación a la Resolución N° 2997 del 29 de agosto de 2007 del Ministerio de la Protección Social "Por la cual se establece el reglamento técnico sobre los requisitos sanitarios que deben cumplir los lactosueros en polvo, como materia prima de alimentos para consumo humano y se dictan otras disposiciones", notificada mediante el documento identificado con la signatura G/SPS/N/COL/126/Add.1 del 2 de octubre de 2007. Se refiere al proyecto de modificación parcial del articulo 6° Requisitos fisicoquímicos y microbiológicos de los lactosueros en polvo, de la Resolución Nº 2997. Texto disponible en el Ministerio de Comercio, Industria y Turismo, Dirección de Regulación, Organismo Nacional encargado de la Notificación: Punto de Contacto: Responsable: Daniel Héctor Rico R. Correo electrónico: drico@mincomercio.gov.co Calle 28 No.13A - 15, tercer piso Bogotá, D.C., Colombia Tel: +(571) 606 7676, ext.1690 Fax: +(571) 241 0480

Products Covered:

Regulation Type: Addendum to Regular Notification

Food safety Labelling Packaging Bacteria Heavy metals Food additives Contaminants Human health

Partial revision of the Japanese Pharmacopoeia Fifteenth edition

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Distribution date: 18 July 2008

Products Covered: Drugs (HS: 30)

Regulation Type: Regular notification

Draft Decision of the Government of the Republic of Armenia "On Maximum Residue Limits (MRLs) of veterinary medicines in food products of animal origin"

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Distribution date: 16 July 2008

The Draft degree establishes MRLs of veterinary medicine in food products of animal origin.

Products Covered: Food

Regulation Type: Regular notification

Food safety Human health Maximum residue limits (MRLs) Veterinary drugs

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

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

Products Covered: Fertilisers (HS: 31)

Regulation Type: Regular notification

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

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

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