Partial amendment to the Minimum Requirements for Biological Products (4 pages, available in English).

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Distribution date: 01 March 2013 | Final date for Comment: 01 April 2013

The Minimum Requirements for Biological Products are to be partially amended to add new interchangeable methods to the standard for vaccines and blood products, etc.

Products Covered: Drugs (HS:30)

Regulation Type: Regular notification

Human health

Partial amendment to the Minimum Requirements for Biological Products (4 pages, available in English).

Product Image

Distribution date: 01 March 2013 | Final date for Comment: 01 April 2013

The Minimum Requirements for Biological Products are to be partially amended to add new interchangeable methods to the standard for vaccines and blood products, etc.

Products Covered: Drugs (HS:30)

Regulation Type: Regular notification

Human health

El Gobierno de la República de Costa Rica informa que notificó el 04 de junio de 2004 el RTCR: 383: 2004, Reglamento Técnico Nacional para Cementos Hidráulicos, bajo la signatura G/TBT/N/CRI/9, con la finalidad de definir los parámetros de calidad de los cementos hidráulicos y de los componentes de éstos que normalmente se usan en el territorio nacional, sean producidas localmente o importados. Así como establecer la clasificación de dichos cementos por tipos, con sus respectivas especificaciones. ; ; Razón por la cual, se le comunica a los países miembros, que se realiza este Addendum informando la reforma de los siguientes puntos: ; ; 1. Se reforma el acápite 5 “Toma de Muestras”, el acápite 7 “De la Verificación o Control de la Calidad”, el numeral 11.3 del acápite 11 “Tablas” y la Tabla 3 denominada “Requerimientos químicos para cementos hidráulicos” del Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos. Especificaciones del 01 de octubre de 2004 y su reforma. ; ; 2. Se adiciona un párrafo al artículo 5º, inciso 1º, acápite b) del Decreto Ejecutivo N° 28113-S de 10 de setiembre de 1999, “Reglamento para el Registro de Productos Peligrosos”, o la versión vigente, publicado en el Alcance N° 74 al Diario Oficial La Gaceta N° 194 del 06 de octubre de 1999. ; ; 3. Se adicionan los numerales 2.21 a 2.26 del acápite 2 “Documentos de Referencia”, el numeral 6.2 y el 6.3 del acápite 6 “Métodos de Análisis”, un nuevo acápite 10 “Verificación” y consecuentemente se corre la numeración a fin de que el acápite 10 pase a conformar el acápite 11 y se le pueda adicionar los numerales del 11.8 a 11.13, del nuevo numeral 11 “Bibliografía”. Todo perteneciente al Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos. Especificaciones del 01 de octubre de 2004 y su reforma. ; ; 4. Se deroga el numeral 9.2.7 del acápite 9 “Etiquetado, perteneciente al Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos” y el Decreto Ejecutivo N° 32254-MEIC, Reglamento para el Registro de Productores e Importadores de Cemento, publicado en La Gaceta N° 50 del 11 de marzo de 2005 y su reforma. ; ; 5. Se genera un Transitorio Único. ; ; Dado que nuestro país está urgido de esta reglamentación, se brinda como plazo para recibir observaciones, hasta el 31 de Marzo de 2013. ; ; El documento puede ser solicitado a la siguiente dirección electrónica: http://www.meic.go.cr/reglatec/consulta/cemento.pdf ; ; Centro de Obstáculos Técnicos al Comercio ; ; Sitio en Internet: http://www.reglatec.go.cr ; Punto de Contacto OMC: [email protected] ; Teléfono: (506) 2291-2115, ext. 206 ; Fax: (506) 2291-2015 ; San José, Costa Rica ; http://members.wto.org/crnattachments/2013/tbt/CRI/13_0957_00_s.pdf

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Distribution date: 06 March 2013 | Final date for Comment: 13 May 2025

Products Covered: HS tariff item No. 2523.90.00.00

Regulation Type: Addendum to Regular Notification

El Gobierno de la República de Costa Rica informa que notificó el 04 de junio de 2004 el RTCR: 383: 2004, Reglamento Técnico Nacional para Cementos Hidráulicos, bajo la signatura G/TBT/N/CRI/9, con la finalidad de definir los parámetros de calidad de los cementos hidráulicos y de los componentes de éstos que normalmente se usan en el territorio nacional, sean producidas localmente o importados. Así como establecer la clasificación de dichos cementos por tipos, con sus respectivas especificaciones. ; ; Razón por la cual, se le comunica a los países miembros, que se realiza este Addendum informando la reforma de los siguientes puntos: ; ; 1. Se reforma el acápite 5 “Toma de Muestras”, el acápite 7 “De la Verificación o Control de la Calidad”, el numeral 11.3 del acápite 11 “Tablas” y la Tabla 3 denominada “Requerimientos químicos para cementos hidráulicos” del Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos. Especificaciones del 01 de octubre de 2004 y su reforma. ; ; 2. Se adiciona un párrafo al artículo 5º, inciso 1º, acápite b) del Decreto Ejecutivo N° 28113-S de 10 de setiembre de 1999, “Reglamento para el Registro de Productos Peligrosos”, o la versión vigente, publicado en el Alcance N° 74 al Diario Oficial La Gaceta N° 194 del 06 de octubre de 1999. ; ; 3. Se adicionan los numerales 2.21 a 2.26 del acápite 2 “Documentos de Referencia”, el numeral 6.2 y el 6.3 del acápite 6 “Métodos de Análisis”, un nuevo acápite 10 “Verificación” y consecuentemente se corre la numeración a fin de que el acápite 10 pase a conformar el acápite 11 y se le pueda adicionar los numerales del 11.8 a 11.13, del nuevo numeral 11 “Bibliografía”. Todo perteneciente al Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos. Especificaciones del 01 de octubre de 2004 y su reforma. ; ; 4. Se deroga el numeral 9.2.7 del acápite 9 “Etiquetado, perteneciente al Artículo 1° del Decreto Ejecutivo N° 32253-MEIC, RTCR 383:2004 Cementos Hidráulicos” y el Decreto Ejecutivo N° 32254-MEIC, Reglamento para el Registro de Productores e Importadores de Cemento, publicado en La Gaceta N° 50 del 11 de marzo de 2005 y su reforma. ; ; 5. Se genera un Transitorio Único. ; ; Dado que nuestro país está urgido de esta reglamentación, se brinda como plazo para recibir observaciones, hasta el 31 de Marzo de 2013. ; ; El documento puede ser solicitado a la siguiente dirección electrónica: http://www.meic.go.cr/reglatec/consulta/cemento.pdf ; ; Centro de Obstáculos Técnicos al Comercio ; ; Sitio en Internet: http://www.reglatec.go.cr ; Punto de Contacto OMC: [email protected] ; Teléfono: (506) 2291-2115, ext. 206 ; Fax: (506) 2291-2015 ; San José, Costa Rica ; http://members.wto.org/crnattachments/2013/tbt/CRI/13_0957_00_s.pdf

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Distribution date: 06 March 2013 | Final date for Comment: 13 May 2025

Products Covered: HS tariff item No. 2523.90.00.00

Regulation Type: Addendum to Regular Notification

TITLE: Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: With this final rule EPA declares a prion (i.e., proteinaceous infectious particle) to be a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and amends the regulations to expressly include prion within the regulatory definition of pest. This final rule also amends existing pesticide product performance data requirements to clarify that efficacy data are required for pesticide products with prion-related claims. In addition, EPA is announcing the availability of final test guidelines on generating the product performance data for prion-related pesticide products. ; ; DATES: This final rule is effective 29 April 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-02-28/html/2013-04613.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-02-28/pdf/2013-04613.pdf ;

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Distribution date: 06 March 2013 | Final date for Comment: 13 May 2025

Products Covered: Pesticides (HS 3808; ICS 13.020, 65.100)

Regulation Type: Addendum to Regular Notification

TITLE: Declaration of Prion as a Pest Under FIFRA; Related Amendments; and Availability of Final Test Guidelines ; ; AGENCY: Environmental Protection Agency (EPA) ; ; ACTION: Final rule ; ; SUMMARY: With this final rule EPA declares a prion (i.e., proteinaceous infectious particle) to be a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and amends the regulations to expressly include prion within the regulatory definition of pest. This final rule also amends existing pesticide product performance data requirements to clarify that efficacy data are required for pesticide products with prion-related claims. In addition, EPA is announcing the availability of final test guidelines on generating the product performance data for prion-related pesticide products. ; ; DATES: This final rule is effective 29 April 2013. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2013-02-28/html/2013-04613.htm ; http://www.gpo.gov/fdsys/pkg/FR-2013-02-28/pdf/2013-04613.pdf ;

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Distribution date: 06 March 2013 | Final date for Comment: 13 May 2025

Products Covered: Pesticides (HS 3808; ICS 13.020, 65.100)

Regulation Type: Addendum to Regular Notification

Draft of the Eurasian Economic Commission Collegium Decisions on amendments to the Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010

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Distribution date: 06 March 2013 | Final date for Comment: 01 April 2013

The document introduces amendments to CU legislation specifically to the General provisions of the Common veterinary requirements. These amendments specify that establishments of the third countries are obliged to use raw materials of animal origin produced by establishments which have the right to supply the products to the Customs Union territory. This requirement applies for the products which contain components of animal origin.

Products Covered: HS Codes: 0201, 0202, 0203, 0204, 0205 00, 0206, 0207, 0208, 0209, 0210, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0408, 0504 00 000 0, 1601 00, 1602, 1604, 1605, from 190220, from 190420, from 20, from 2104, from 2106, 2301, from 2105 00, 2309, from 2106, from 3501, 3502, 3503 00

Regulation Type: Regular notification

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

Draft of the Eurasian Economic Commission Collegium Decisions on amendments to the Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010

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Distribution date: 06 March 2013 | Final date for Comment: 01 April 2013

The document introduces amendments to CU legislation specifically to the General provisions of the Common veterinary requirements. These amendments specify that establishments of the third countries are obliged to use raw materials of animal origin produced by establishments which have the right to supply the products to the Customs Union territory. This requirement applies for the products which contain components of animal origin.

Products Covered: HS Codes: 0201, 0202, 0203, 0204, 0205 00, 0206, 0207, 0208, 0209, 0210, 0301, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0401, 0402, 0403, 0404, 0405, 0406, 0407, 0408, 0504 00 000 0, 1601 00, 1602, 1604, 1605, from 190220, from 190420, from 20, from 2104, from 2106, 2301, from 2105 00, 2309, from 2106, from 3501, 3502, 3503 00

Regulation Type: Regular notification

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

Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period

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Distribution date: 08 March 2013 | Final date for Comment: 03 May 2013

SUMMARY: The US Food and Drug Administration (FDA) is reopening the comment period for the interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics" that published in the Federal Register of 14 July 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of 7 September 2005 (70 FR 53063), FDA amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, FDA is reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum. Federal Register 78 FR 14012 4 March 2013, http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/pdf/2013-04869.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of final date for comments

Use of Materials Derived From Cattle in Human Food and Cosmetics; Reopening of the Comment Period

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Distribution date: 08 March 2013 | Final date for Comment: 03 May 2013

SUMMARY: The US Food and Drug Administration (FDA) is reopening the comment period for the interim final rule entitled "Use of Materials Derived From Cattle in Human Food and Cosmetics" that published in the Federal Register of 14 July 2004 (69 FR 42256). The interim final rule prohibited the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. In the Federal Register of 7 September 2005 (70 FR 53063), FDA amended the interim final rule to make changes, including providing that the small intestine of cattle, formerly prohibited cattle material, could be used in human food and cosmetics if the distal ileum was removed by a specified procedure or one that the establishment could demonstrate is equally effective in ensuring complete removal of the distal ileum. Since 2005, peer-reviewed studies have been published showing the presence of infectivity in the proximal ileum, jejunum, ileocecal junction, and colon of cattle with BSE. Therefore, FDA is reopening the comment period for the interim final rule to give interested parties an opportunity to comment on the new studies concerning infectivity in parts of the small intestine other than the distal ileum. Federal Register 78 FR 14012 4 March 2013, http://www.gpo.gov/fdsys/pkg/FR-2013-03-04/pdf/2013-04869.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Modification of final date for comments

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