Regulatory Updates
Draft Ministerial Act Number 330, 13 December 2006 (Portaria nº 330, de 13 de dezembro de 2006) (3 pages, in Portuguese).
Distribution date: 10 January 2007
Products Covered: Cosmetics (HS: 3300)
Regulation Type: Regular notification
Draft Ministerial Act Number 330, 13 December 2006 (Portaria nº 330, de 13 de dezembro de 2006) (3 pages, in Portuguese).
Distribution date: 10 January 2007
Products Covered: Cosmetics (HS: 3300)
Regulation Type: Regular notification
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (23 pages, in English).
Distribution date: 10 January 2007
The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis.
Products Covered: Food Labeling (HS: Chapter 2936; ICS: 67.040)
Regulation Type: Regular notification
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis (23 pages, in English).
Distribution date: 10 January 2007
The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to: Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis.
Products Covered: Food Labeling (HS: Chapter 2936; ICS: 67.040)
Regulation Type: Regular notification
Internal Analgesic, Antipyretic, and Anti-rheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labelling. (42 pages, English)
Distribution date: 09 January 2007
The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.
Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS: Chapter 3004; ICS: 11)
Regulation Type: Regular notification
Internal Analgesic, Antipyretic, and Anti-rheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labelling. (42 pages, English)
Distribution date: 09 January 2007
The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labelling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and anti-rheumatic (IAAA) drug products to include new warnings and other labelling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labelling for all OTC IAAA drug products. The new labelling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labelling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use.
Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS: Chapter 3004; ICS: 11)
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) No. 67.01.08:06: Milk products. Pasteurized dairy cream for direct consumption. Specifications. First revision (3 pages, in Spanish).
Distribution date: 09 January 2007
The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.
Products Covered: Dairy cream: International Classification for Standards (ICS) code 67.100; HS tariff headings 04.02 and 04.03
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) No. 67.01.08:06: Milk products. Pasteurized dairy cream for direct consumption. Specifications. First revision (3 pages, in Spanish).
Distribution date: 09 January 2007
The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.
Products Covered: Dairy cream: International Classification for Standards (ICS) code 67.100; HS tariff headings 04.02 and 04.03
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) No. 67.01.10:06: Milk products. Yoghurt. Specifications. First revision (9 pages, in Spanish).
Distribution date: 09 January 2007
The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.
Products Covered: Yoghurt: International Classification for Standards (ICS) code 67.100; HS tariff heading 0403.10
Regulation Type: Regular notification
Salvadoran Mandatory Standard (NSO) No. 67.01.10:06: Milk products. Yoghurt. Specifications. First revision (9 pages, in Spanish).
Distribution date: 09 January 2007
The notified Standard covers the following: purpose, scope, definitions, essential composition and quality factors, food additives, product classification, general, physico-chemical and microbiological characteristics, contaminants, sampling, testing and analysis methods, hygiene, packaging and labelling, storage and transportation, regulatory appendix, monitoring and inspection.
Products Covered: Yoghurt: International Classification for Standards (ICS) code 67.100; HS tariff heading 0403.10
Regulation Type: Regular notification
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