Regulatory Updates
Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use (4 pages, in English)
Distribution date: 01 March 2007
The Food and Drug Administration (FDA) is seeking information to formulate a regulatory position on insect repellent products that contain over-the-counter (OTC) sunscreen ingredients. FDA is considering amending its monograph for OTC sunscreen drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the Environmental Protection Agency (EPA). Elsewhere in this issue of the Federal Register is a companion document in which EPA is also requesting information and comments on these products. The decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to this request for data and information.
Products Covered: Insect repellent - sunscreen drug products (HS: 3304, 3808; ICS: 13.120, 65.100, 71.100)
Regulation Type: Regular notification
Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use (4 pages, in English)
Distribution date: 01 March 2007
The Food and Drug Administration (FDA) is seeking information to formulate a regulatory position on insect repellent products that contain over-the-counter (OTC) sunscreen ingredients. FDA is considering amending its monograph for OTC sunscreen drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the Environmental Protection Agency (EPA). Elsewhere in this issue of the Federal Register is a companion document in which EPA is also requesting information and comments on these products. The decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to this request for data and information.
Products Covered: Insect repellent - sunscreen drug products (HS: 3304, 3808; ICS: 13.120, 65.100, 71.100)
Regulation Type: Regular notification
Draft Ministerial Act number 29 (Portaria Nº 29), issued on 29 January 2007, published in the "Diário Oficial da União" Nº 22 (Federal Official Journal) from 31 January 2007, section 1, pages 18 and 19 (Available only in Portuguese, two pages). The text may be downloaded from the following Internet site: http://extranet.agricultura.gov.br/sislegis-consulta/consultarLegislacao.do?operacao=visualizar&id=17601
Distribution date: 28 February 2007
Draft Technical Regulation which disciplines the requirements and the criteria for authorization of antimicrobial products for veterinary use.
Products Covered: Antimicrobial products for veterinary use
Regulation Type: Regular notification
Draft Ministerial Act number 29 (Portaria Nº 29), issued on 29 January 2007, published in the "Diário Oficial da União" Nº 22 (Federal Official Journal) from 31 January 2007, section 1, pages 18 and 19 (Available only in Portuguese, two pages). The text may be downloaded from the following Internet site: http://extranet.agricultura.gov.br/sislegis-consulta/consultarLegislacao.do?operacao=visualizar&id=17601
Distribution date: 28 February 2007
Draft Technical Regulation which disciplines the requirements and the criteria for authorization of antimicrobial products for veterinary use.
Products Covered: Antimicrobial products for veterinary use
Regulation Type: Regular notification
Draft Resolution on the extension of food additive use (Available only in Portuguese, 2 pages).
Distribution date: 28 February 2007
This draft technical regulation approves the use extension of the additive INS 460i Microcrystalline Cellulose as stabilizer in coconut milk as GMP.
Products Covered: Food additive
Regulation Type: Regular notification
Draft Resolution on the extension of food additive use (Available only in Portuguese, 2 pages).
Distribution date: 28 February 2007
This draft technical regulation approves the use extension of the additive INS 460i Microcrystalline Cellulose as stabilizer in coconut milk as GMP.
Products Covered: Food additive
Regulation Type: Regular notification
Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the sanitary requirements for vinegar for human consumption" (9 pages, in Spanish).
Distribution date: 22 February 2007
Se establecen los requisitos sanitarios que deben cumplir las fábricas que procesen, envasen, transporten, expendan, importen, exporten y comercialicen vinagre para consumo humano; Objeto; Campo de aplicación; Condiciones básicas de higiene; Denominaciones; Prácticas permitidas, prohibidas; Materias primas e ingredientes; Condiciones generales del vinagre; Aditivos; Requisitos fisicoquímicos; Vinagres no aptos para el consumo humano; Envase y rotulado; Inspección, vigilancia, control, medidas de seguridad y sanciones.
Products Covered: Vinegar for human consumption
Regulation Type: Regular notification
Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the sanitary requirements for vinegar for human consumption" (9 pages, in Spanish).
Distribution date: 22 February 2007
Se establecen los requisitos sanitarios que deben cumplir las fábricas que procesen, envasen, transporten, expendan, importen, exporten y comercialicen vinagre para consumo humano; Objeto; Campo de aplicación; Condiciones básicas de higiene; Denominaciones; Prácticas permitidas, prohibidas; Materias primas e ingredientes; Condiciones generales del vinagre; Aditivos; Requisitos fisicoquímicos; Vinagres no aptos para el consumo humano; Envase y rotulado; Inspección, vigilancia, control, medidas de seguridad y sanciones.
Products Covered: Vinegar for human consumption
Regulation Type: Regular notification
Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the sanitary requirements for vinegar for human consumption" (9 pages, in Spanish).
Distribution date: 22 February 2007
Sanitary requirements for establishments that process, package, transport, sell, import, export and market vinegar for human consumption: Purpose; Scope; Basic hygiene requirements; Names; Permitted/prohibited practices; Raw materials and ingredients; General conditions applicable to vinegar; Additives; Physico-chemical conditions; Vinegars not suitable for human consumption; Packaging and labelling; Inspection, surveillance, control, safety measures and penalties.
Products Covered: Vinegar for human consumption.
Regulation Type: Regular notification
Draft Ministry of Social Welfare Resolution "Establishing technical regulations on the sanitary requirements for vinegar for human consumption" (9 pages, in Spanish).
Distribution date: 22 February 2007
Sanitary requirements for establishments that process, package, transport, sell, import, export and market vinegar for human consumption: Purpose; Scope; Basic hygiene requirements; Names; Permitted/prohibited practices; Raw materials and ingredients; General conditions applicable to vinegar; Additives; Physico-chemical conditions; Vinegars not suitable for human consumption; Packaging and labelling; Inspection, surveillance, control, safety measures and penalties.
Products Covered: Vinegar for human consumption.
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events