Regulatory Updates
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
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: PuntocontactoOTCECU@mipro.gob.ec/jcadena@mipro.gob.ec
Distribution date: 17 January 2018
Products Covered: 3305.10.00.00
Regulation Type: Addendum to Regular Notification
Standards for Specification, Scope, Application and Limitation of Food Additives
Distribution date: 16 January 2018
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
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: drico@mincit.gov.co; mgonzalezs@mincit.gov.co 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
Products Covered: Detergents and soaps (HS codes: 3401, 3402 and 3405400000) ;
Regulation Type: Addendum to 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
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 - 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
RDC Nº 205, December 28th, 2017.
Distribution date: 12 January 2018
This Resolution establishes special procedure for approval of clinical trials, good manufacturing practices certification and registration of new medicines for treatment, diagnosis or prevention of rare diseases. This resolution applies to new medicines for rare diseases.The special procedure applies to:I – clinical trials authorization to be performed in Brazil for the evaluation of medicines for rare diseases; II - certification of good manufacturing practices of medicines for rare diseases; III – market authorization of new medicines for rare diseases.A medicine for a rare disease shall be considered a medicine intended to treat, diagnose or prevent a rare disease and: I - is used in a serious debilitating condition; II - proposes to change in a clinically significant way the disease evolution or to make possible the remission of the disease.The request of approval for clinical trials and registration of a new medicine for rare diseases is established in this Resolution.If it is not confirmed during the technical analysis that the petitions for approval of clinical trials and registration of new medicine refers to rare disease, the petition will be rejected.Submission of clinical medicine development dossier, specific clinical trial dossier, substantial modification by inclusion of protocol should be performed according to specific legislation regarding clinical trials in Brazil, added by the documentation established in this Resolution.The request for registration of a new rare disease medicine must be carried out according to specific legislation for each regulatory category, added by the documentation described in this Resolution.Supplemental data and additional evidence may be allowed after the registration has been granted, by means of a signature of an agreement between Anvisa and the company requesting registration. Failure to comply with the agreement may lead to cancellation of the registration.Anvisa may permit the use of an international comparator medicine registered with another regulatory authority, under the terms set forth in this Resolution in the event of a request for registration of a rare disease medicine with the same registered medicine IFAs.Companies that submit a request for registration of new medicine in accordance with this resolution must present a maximum price definition dossier concomitantly with the registration requestFor applications for registration of new medicines for rare diseases, it does not apply the provisions of art. 2 of the Resolution of the Collegiate Board of Directors - RDC nº 20, of 10 April 2013.This resolution changes the text of §2 of art. 47 of the Resolution of the Collegiate Board of Directors - RDC nº 9 of 20 February 2015.
Products Covered: 3003 3004: Medicaments
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: 12 January 2018 | Final date for Comment: 13 March 2018
Proposed maximum residue limits (MRLs) for the following agricultural chemical. Pesticide: Clethodim. Japan has received some comments and relevant data on document G/SPS/N/JPN/515 circulated on 16 May 2017. The MHLW has decided to modify the draft maximum residue limits (MRLs) for Clethodim in "Corn" based on the provided data.
Products Covered: - Meat and edible meat offal (HS Codes: 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 Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 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 Codes: 08.02, 08.07, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.03 and 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12)- Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Revision to 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: 12 January 2018 | Final date for Comment: 13 March 2018
Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Desmedipham.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.09 and 07.10) - Edible fruits and nuts, peel of citrus/melons (HS Code: 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)- Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.12)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
