Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 15 January 2018 | Final date for Comment: 16 March 2018
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Veterinary drug/ Feed additive: Flavophospholipol.
Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09) -Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08) -Products of animal origin (HS: 05.04) -Animal or vegetable fats and oils (HS: 15.01 and 15.02)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 15 January 2018 | Final date for Comment: 16 March 2018
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Tricyclazole.
Products Covered: -Fish and crustaceans, molluscs and other aquatic invertebrates (HS: 03.02, 03.03 and 03.04) -Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) -Edible fruits and nuts, peel of citrus/melons (HS: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Coffee, tea, mate and spices (HS: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) -Oleaginous fruits, miscellaneous grains, seeds and fruits (HS: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) -Cacao and cacao preparations (HS: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 15 January 2018 | Final date for Comment: 16 March 2018
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Procymidone.
Products Covered: -Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) -Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08) -Products of animal origin (HS: 05.04) -Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) -Edible fruits and nuts, peel of citrus/melons (HS: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) -Coffee, tea, mate and spices (HS: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) -Cereals (HS: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) -Oleaginous fruits, miscellaneous grains, seeds and fruits (HS: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)-Animal or vegetable fats and oils (HS: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
The Republic of Colombia hereby notifies a draft amendment to Article 7, Conformity assessment procedure, of Resolution No. 689 of 3 May 2016 of the Ministry of Health and Social Welfare and the Ministry of the Environment and Sustainable Development, "Adopting the Technical Regulation establishing the maximum levels of phosphorus and the biodegradability of surfactants in detergents and soaps, and introducing other provisions", notified on 12 May 2016 by the World Trade Organization in document G/TBT/N/COL/214/Add.1. Comments on the draft amendment may be submitted until 15 April 2018. Text available online at: http://extranet.comunidadandina.org/sirt/public/index.aspx Enquiry point: Contact person: Daniel Héctor Rico R. Email: [email protected]; [email protected] Calle 28, N° 13A - 15, tercer piso Bogotá, D.C., Colombia Tel.: (+57-1) 606 7676, Ext. 1690/1340 Website: http://www.mincit.gov.co/publicaciones.php?id=33051/http://www.sical.gov.co/reglamentos-tecnicos Also available at:
Distribution date: 15 January 2018 | Final date for Comment: 29 April 2025
Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;
Regulation Type: Addendum to Regular Notification
Standards for Specification, Scope, Application and Limitation of Food Additives
Distribution date: 16 January 2018 | Final date for Comment: 29 April 2025
The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives (G/SPS/N/TPKM/426). The final amendment has entered into force on 9 January 2018.
Products Covered:
Regulation Type: Addendum to Regular Notification
By means of this Addendum No. 1, the Republic of Ecuador advises that "Sanitary Technical Regulation for cosmetics, domestic hygiene products and absorbent personal hygiene products" notified in document G/TBT/N/ECU/331 of 27 February 2017, has been issued pursuant to Resolution No. 6 of 17 February 2017 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA), published in Official Journal No. 968 of 22 March 2017. Text available from: Ministerio de Industrias y Productividad (Ministry of Industry and Productivity), Subsecretaría de la Calidad (Under-Secretariat for Quality), Organismo Nacional encargado de la Notificación (National Notification Authority): Contact person: Juan Carlos Cadena Plataforma Gubernamental de Gestión Financiera - Piso 8 Bloque amarillo Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Tel.: (+593-2) 3948760, Ext. 2358/2272 Enquiry point: [email protected]/[email protected]
Distribution date: 17 January 2018 | Final date for Comment: 29 April 2025
Products Covered: 3305.10.00.00
Regulation Type: Addendum to Regular Notification
Draft Amendment of the Ordinance for Enforcement of the Fertilizer Regulation Act, etc.
Distribution date: 18 January 2018 | Final date for Comment: 17 February 2018
Currently ingredients derived from cattle, including gelatin and collagen, can be used for fertilizers provided that those ingredients undergo measures with regard to making prions inert or keeping livestock away from prion sources. Hereafter bovine hide gelatin and collagenare are to be allowed for using as an ingredient of fertilizers without taking these measures. In addition, for using bovine flesh-bone gelatin and collagen as an ingredient of fertilizers, additional measures to reduce infectivity are to be available.
Products Covered: Fertilizer HS: 3101, 3105
Regulation Type: Regular notification
Draft amendment of the Ministrial Notification No.875 of the Ministry of Agriculture, Forestry and Fisheries of 2014
Distribution date: 18 January 2018 | Final date for Comment: 17 February 2018
In order to use flesh-bone meal as an ingredient of fertilizers, taking measures to keep livestock away from them, such as adding designated materials, is required so that Transmissible Spongiform Encephalopathy (TSE) should be prevented. Now five materials proved to be effective in keeping livestock away are to be newly designated.
Products Covered: Fertilizer (HS: 3101, 3102, 3104, 3105)
Regulation Type: Regular notification
Measures for Review and Approval of Drug Master File (DMF) in Support of Finished Drug Product Application (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
These measures are formulated to establish a drug quality management system in which marketing authorization holder is the first responsible person, to improve the quality and efficiency of drug registration, and to ensure the safety, effectiveness and quality of drug. Based on management process for review and approval of drug master file (DMF) in support of finished drug product application, these measures consist of seven parts, respectively，General Provisions, Responsibilities and Obligations, DMF Listing, Review and Approval of DMF in Support of Finished Drug Product Application, Alteration and Termination, Supervision and Management, Supplementary Articles.
Products Covered: Drugs ICS: 11.120.10 HS: 30
Regulation Type: Regular notification
Announcement for Adjustment of Review and Approval Process of Drug Clinical Study (Draft)
Distribution date: 18 January 2018 | Final date for Comment: 19 March 2018
This announcement is formulated by reference to international advanced experience, which aims to optimize the review process of drug clinical study, strengthen the communication with applicants, and enhance the review quality and efficiency of drug clinical study. This announcement consists of four parts according to the review process of drug clinical study, including preparation and application of communication meeting, convening of the communication meeting, acceptance, review and approval of drug clinical study application and other related items. In addition, the announcement has three annexes, i.e. application form of communication meeting, requirement for materials of communication meeting and requirement for application of dossier of phase I clinical study.
Products Covered: Drugs ICS: 11.120.10. HS: 30
Regulation Type: Regular notification
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