Regulatory Updates

NSO 67.23.02:05: Margarina. Especificaciones (Salvadoran Mandatory Standard (NSO) No. 67.23.02:05: Margarine. Specifications (10 pages, in Spanish).

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Distribution date: 12 July 2005

This Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, chemical contaminants, analysis of physico-chemical components, microbiological contaminants, methods of analysis, hygiene, packaging, labelling, conformity with other standards, technical references, monitoring and inspection.

Products Covered: Margarine (HS tariff heading 1517)

Regulation Type: Regular notification

Human health Food additives Contaminants Bacteria Food safety Labelling Packaging

Draft TIS 53-2548 (2005) Matches (13 pages, in Thai)

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Distribution date: 08 July 2005

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 53-2536(1993) which is a mandatory standard and replace it with TIS 53-2548(2005). The standard specifies types, containers, splint, match head, wearing strength of friction surface, striking performance, ignition and absence of afterglow. Includes packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Miscellaneous home equipment (HS Chapter:  3605;  ICS:  97.180)

Regulation Type: Regular notification

Draft TIS 53-2548 (2005) Matches (13 pages, in Thai)

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Distribution date: 08 July 2005

The Thai Industrial Standards Institute (TISI) has proposed to withdraw TIS 53-2536(1993) which is a mandatory standard and replace it with TIS 53-2548(2005). The standard specifies types, containers, splint, match head, wearing strength of friction surface, striking performance, ignition and absence of afterglow. Includes packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Miscellaneous home equipment (HS Chapter:  3605;  ICS:  97.180)

Regulation Type: Regular notification

Draft Resolution Nº 42 - Technical Regulation on registration of “in vitro” diagnostic products. (21 pages, in Portuguese)

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Distribution date: 07 July 2005

Products Covered: In-vitro diagnostic products (HS 3822;  3002;  3821)

Regulation Type: Regular notification

Draft Resolution Nº 42 - Technical Regulation on registration of “in vitro” diagnostic products. (21 pages, in Portuguese)

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Distribution date: 07 July 2005

Products Covered: In-vitro diagnostic products (HS 3822;  3002;  3821)

Regulation Type: Regular notification

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3; Final Rule. (4 pages; available in English)

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Distribution date: 05 July 2005

FDA is amending the food additive regulations in 21 CFR 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages for special dietary use in reducing or maintaining body weight.

Products Covered: Vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages for special dietary use

Regulation Type: Regular notification

Human health Food safety

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3; Final Rule. (4 pages; available in English)

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Distribution date: 05 July 2005

FDA is amending the food additive regulations in 21 CFR 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages for special dietary use in reducing or maintaining body weight.

Products Covered: Vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages for special dietary use

Regulation Type: Regular notification

Human health Food safety

National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing (6 pages, in English).

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Distribution date: 04 July 2005

On10 November 2003, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for miscellaneous organic chemical manufacturing under the authority of section 112 of the Clean Air Act (CAA). This action proposes clarifications to the compliance requirements for flares and the alternative standard, which limits the outlet concentration to 20 parts per million. This action proposes an expansion of the scope of the vapor balancing alternative for storage tanks, modifications to the procedures for correcting measured concentrations at the outlet of combustion devices to account for supplemental gases, and clarification of the signature requirements for the notification of compliance status report. This action also proposes revisions of several referencing and drafting errors. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the preamble to the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw only those provisions on which we received significant adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to the withdrawn provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period before taking the subsequent final action. Any parties interested in commenting must do so at this time.

Products Covered: Air Pollutants  (HS:  Chapter:  29;  ICS:  13.040)

Regulation Type: Regular notification

National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing (6 pages, in English).

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Distribution date: 04 July 2005

On10 November 2003, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for miscellaneous organic chemical manufacturing under the authority of section 112 of the Clean Air Act (CAA). This action proposes clarifications to the compliance requirements for flares and the alternative standard, which limits the outlet concentration to 20 parts per million. This action proposes an expansion of the scope of the vapor balancing alternative for storage tanks, modifications to the procedures for correcting measured concentrations at the outlet of combustion devices to account for supplemental gases, and clarification of the signature requirements for the notification of compliance status report. This action also proposes revisions of several referencing and drafting errors. In the Rules and Regulations section of this Federal Register, we are taking direct final action on the proposed amendments because we view the amendments as noncontroversial and anticipate no adverse comments. We have explained our reasons for the amendments in the preamble to the direct final rule. If we receive no adverse comments, we will take no further action on the proposed amendments. If we receive adverse comments, we will withdraw only those provisions on which we received significant adverse comments. We will publish a timely withdrawal in the Federal Register indicating which provisions will become effective and which provisions are being withdrawn. If part or all of the direct final rule in the Rules and Regulations section of today's Federal Register is withdrawn, all comments pertaining to the withdrawn provisions will be addressed in a subsequent final rule based on the proposed amendments. We will not institute a second comment period before taking the subsequent final action. Any parties interested in commenting must do so at this time.

Products Covered: Air Pollutants  (HS:  Chapter:  29;  ICS:  13.040)

Regulation Type: Regular notification

Honduran Standard-Central American Technical Regulation No. 75.01.21:05: Petroleum Products. Liquefied Petroleum Gases: Commercial Propane, Commercial Butane and Mixtures Thereof. Specifications. (9 pages, in Spanish)

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Distribution date: 01 July 2005

Este reglamento técnico se debe aplicar al producto denominado Gas Licuado de Petróleo (GLP) que se comercializa en los países centroamericanos. Especifica las características físico químicas del Gas Licuado de Petróleo (GLP)para dos calidades: Propano Comercial y Butano Comercial, generalmente utilizados como combustible de calentamiento en el sector doméstico, comercial e industrial, como combustible automotriz y como materia prima para petroquímica. Se podrá utilizar cualquier mezcla de estos productos siempre que las mezclas cumplan con las especificaciones establecidas en este reglamento.

Products Covered: HS: 2711;  ICS: 75.160.30

Regulation Type: Regular notification

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