Proposal for a directive of the European Parliament and of the Council on the placing on the market of pyrotechnic articles (35 pages, in all official languages of the EU).

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Distribution date: 22 December 2005 | Final date for Comment: 22 April 2025

Products Covered: Fireworks and other pyrotechnic articles (HS:  3604)

Regulation Type: Regular notification

Requirements for the importation of fish into the Republic of Cuba (4 pages, in Spanish)

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Distribution date: 05 January 2006 | Final date for Comment: 22 April 2025

Places where fish or fish products are produced in a country, a zone or an aquaculture establishment must be approved and monitored for export purposes by the official veterinary service and be subject to an official fish health surveillance scheme. The country, zone or aquaculture establishment involved must be free from the pathogens that cause the following diseases, as listed in the Aquatic Animal Health Code: epizootic haematopoietic necrosis, infectious haematopoietic necrosis, spring viraemia of carp, viral haemorrhagic septicaemia, infectious pancreatic necrosis, infectious salmon anaemia, epizootic ulcerative syndrome, bacterial kidney disease (Renibacterium salmoninarum), gyrodactylosis (Gyrodactylus salaris) and red sea bream iridoviral disease. Visual inspections must be carried out to detect any visible parasites. Places of production in a country, zone or aquaculture establishment must be officially authorized by the competent authorities of the exporting country. The final product must comply with the following: Product identification (eviscerated or uneviscerated; cultured or wild stock; species; scientific name; date of production; expiry date; packaging type; total weight (kg.) or number (x 100); and stamp or seal of the official veterinary service). Product origin (name and address of the establishment approved by the official veterinary service). Product destination (place of shipment; destination (country and place); nature and identification of means of transport; container and seal number; name and address of the consignor; and name and address of the consignee). Description of content: (cont'd) Transport (under official seal in refrigerated vehicles adapted for this purpose which ensure conditions that prevent the deterioration, alteration or contamination of the products). The official veterinary health certificate covering the export must contain the following: a description of the product, information on the origin and destination of the product, health certification reflecting the above-mentioned points, confirmation that the products are suitable for human consumption, and the name, signature and stamp or seal of the official veterinary service. The product will be accompanied by a certificate of quality issued by the country of origin stating the results of the organoleptic analyses (dehydration, colour, smell, texture and taste), chemical analyses (total volatile basic nitrogen - TVB-N, total trimethylamine nitrogen - TMA-N, histamine - n-9 c-2 m-100 ppm and M-200 ppm, and contaminants - heavy metals and halogenated substances) and microbiological analyses (see table): INDICATORS Limits per g or ml n c m M m.o. at 30 o C 5 2 105 106 Coliforms at 45 o C 5 2 0.3 2.1 E. coli 5 0 < 0.3 -- Salmonella in 25 g 5 0 0 -- Enteropathogen (Vibrio cholerae) 5 0 0 -- V. parahaemolyticus 5 0 0 -- With regard to complaints/alerts, the official veterinary service of the exporting country must urgently inform the National Directorate of the Institute of Veterinary Medicine of the Republic of Cuba (Dirección Nacional del Instituto de Medicina Veterinaria de la República de Cuba), in the event of any outbreak in its territory of the diseases listed in the Aquatic Animal Health Code within three months of shipment of the products.

Products Covered: Eviscerated and uneviscerated fish, cultured fish stocks and wild fish stocks.

Regulation Type: Regular notification

Animal diseases Food safety Animal health Human health Pests

Requirements for the importation of fish into the Republic of Cuba (4 pages, in Spanish)

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Distribution date: 05 January 2006 | Final date for Comment: 22 April 2025

Places where fish or fish products are produced in a country, a zone or an aquaculture establishment must be approved and monitored for export purposes by the official veterinary service and be subject to an official fish health surveillance scheme. The country, zone or aquaculture establishment involved must be free from the pathogens that cause the following diseases, as listed in the Aquatic Animal Health Code: epizootic haematopoietic necrosis, infectious haematopoietic necrosis, spring viraemia of carp, viral haemorrhagic septicaemia, infectious pancreatic necrosis, infectious salmon anaemia, epizootic ulcerative syndrome, bacterial kidney disease (Renibacterium salmoninarum), gyrodactylosis (Gyrodactylus salaris) and red sea bream iridoviral disease. Visual inspections must be carried out to detect any visible parasites. Places of production in a country, zone or aquaculture establishment must be officially authorized by the competent authorities of the exporting country. The final product must comply with the following: Product identification (eviscerated or uneviscerated; cultured or wild stock; species; scientific name; date of production; expiry date; packaging type; total weight (kg.) or number (x 100); and stamp or seal of the official veterinary service). Product origin (name and address of the establishment approved by the official veterinary service). Product destination (place of shipment; destination (country and place); nature and identification of means of transport; container and seal number; name and address of the consignor; and name and address of the consignee). Description of content: (cont'd) Transport (under official seal in refrigerated vehicles adapted for this purpose which ensure conditions that prevent the deterioration, alteration or contamination of the products). The official veterinary health certificate covering the export must contain the following: a description of the product, information on the origin and destination of the product, health certification reflecting the above-mentioned points, confirmation that the products are suitable for human consumption, and the name, signature and stamp or seal of the official veterinary service. The product will be accompanied by a certificate of quality issued by the country of origin stating the results of the organoleptic analyses (dehydration, colour, smell, texture and taste), chemical analyses (total volatile basic nitrogen - TVB-N, total trimethylamine nitrogen - TMA-N, histamine - n-9 c-2 m-100 ppm and M-200 ppm, and contaminants - heavy metals and halogenated substances) and microbiological analyses (see table): INDICATORS Limits per g or ml n c m M m.o. at 30 o C 5 2 105 106 Coliforms at 45 o C 5 2 0.3 2.1 E. coli 5 0 < 0.3 -- Salmonella in 25 g 5 0 0 -- Enteropathogen (Vibrio cholerae) 5 0 0 -- V. parahaemolyticus 5 0 0 -- With regard to complaints/alerts, the official veterinary service of the exporting country must urgently inform the National Directorate of the Institute of Veterinary Medicine of the Republic of Cuba (Dirección Nacional del Instituto de Medicina Veterinaria de la República de Cuba), in the event of any outbreak in its territory of the diseases listed in the Aquatic Animal Health Code within three months of shipment of the products.

Products Covered: Eviscerated and uneviscerated fish, cultured fish stocks and wild fish stocks.

Regulation Type: Regular notification

Animal diseases Food safety Animal health Human health Pests

Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions (5 pages, in English)

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Distribution date: 06 January 2006 | Final date for Comment: 22 April 2025

EPA is proposing to revoke specific tolerances and tolerance exemptions for residues of the insecticides paraformaldehyde and tetradifon; fungicides captafol, hexaconazole, and sodium dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled food use registrations or deleted food uses from registrations following requests for voluntary cancellation or use deletion by the registrants, or non-payment of registration maintenance fees. Also, stakeholders have withdrawn their support for import tolerances for captafol and hexaconazole. EPA expects to determine whether any individuals or groups want to support these tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on 2 August 1996. The regulatory actions proposed in this document pertain to the proposed revocation of 39 tolerances and tolerance exemptions of which 38 would be counted as tolerance reassessments toward the August 2006 review deadline.

Products Covered: Pesticides (HS Chapter:  3808;  ICS:  13)

Regulation Type: Regular notification

Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions (5 pages, in English)

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Distribution date: 06 January 2006 | Final date for Comment: 22 April 2025

EPA is proposing to revoke specific tolerances and tolerance exemptions for residues of the insecticides paraformaldehyde and tetradifon; fungicides captafol, hexaconazole, and sodium dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled food use registrations or deleted food uses from registrations following requests for voluntary cancellation or use deletion by the registrants, or non-payment of registration maintenance fees. Also, stakeholders have withdrawn their support for import tolerances for captafol and hexaconazole. EPA expects to determine whether any individuals or groups want to support these tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on 2 August 1996. The regulatory actions proposed in this document pertain to the proposed revocation of 39 tolerances and tolerance exemptions of which 38 would be counted as tolerance reassessments toward the August 2006 review deadline.

Products Covered: Pesticides (HS Chapter:  3808;  ICS:  13)

Regulation Type: Regular notification

Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monograph (10 pages, in English)

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Distribution date: 06 January 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.

Products Covered: Human Drug Products  (HS Chapter:  3003;  ICS:  11.120)

Regulation Type: Regular notification

Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monograph (10 pages, in English)

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Distribution date: 06 January 2006 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.

Products Covered: Human Drug Products  (HS Chapter:  3003;  ICS:  11.120)

Regulation Type: Regular notification

Draft of Scope, Application and Specification Standards for Food Additive: Calcium Citrate (Available in English, 2 pages)

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Distribution date: 10 January 2006 | Final date for Comment: 22 April 2025

To establish the application and specification standards for a new food additive, calcium citrate, as nutritional additive.

Products Covered: Calcium citrate

Regulation Type: Regular notification

Food safety Human health

Draft of Scope, Application and Specification Standards for Food Additive: Calcium Citrate (Available in English, 2 pages)

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Distribution date: 10 January 2006 | Final date for Comment: 22 April 2025

To establish the application and specification standards for a new food additive, calcium citrate, as nutritional additive.

Products Covered: Calcium citrate

Regulation Type: Regular notification

Food safety Human health

Central American Technical Regulation No. 01.01.11:05. Quantity of Product in Prepackages (21 pages, in Spanish).

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Distribution date: 11 January 2006 | Final date for Comment: 22 April 2025

Establece los requisitos de metrología legal para productos preempacados (conocidos también como bienes de consumo preempacados o preembalados) etiquetados en cantidades nominales predeterminadas de masa, volumen, longitud, área o conteo, y los procedimientos y planes de muestreo para uso de los oficiales de metrología legal en la verificación de la cantidad de producto en preempacados.

Products Covered: HS Chapters 02-38

Regulation Type: Regular notification

Labelling Metrology

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