Regulatory Updates
Pharmacists' Regulations (Cosmetics) 5777-2017 The draft regulations, notified in G/TBT/N/ISR/709, dated 23 October 2013, have been replaced by the Israel Ministry of Health. This new draft lowers trade barriers and simplifies import procedures. The full text of the revised regulations is available online at:
Distribution date: 07 June 2017
Products Covered: Cosmetics (HS: Chapter 33; ICS: 71.100.70).
Regulation Type: Addendum to Regular Notification
Proyecto de Resolución Directoral para el establecimiento de requisitos fitosanitarios de necesario cumplimiento en la importación de Rhizobium radiobacter strain GV 3101 de origen y procedencia Alemania (Draft Directorial Resolution establishing the mandatory phytosanitary requirements governing the importation into Peru of Rhizobium radiobacter strain GV 3101 originating in and coming from Germany)
Distribution date: 01 June 2017
The notified draft Directorial Resolution sets out the phytosanitary requirements governing the importation into Peru of Rhizobium radiobacter strain GV 3101 originating in and coming from Germany, following the completion of the relevant pest risk analysis.
Products Covered: HS tariff subheading 3002.90.10.00: Rhizobium radiobacter strain GV 3101
Regulation Type: Regular notification
Decision of Energy Regulatory Commission exempting parties licensed to transport, store, distribute and sell petroleum products to the public from having to submit the outcome of evaluations on compliance with petroleum product quality specifications pursuant to Emergency Mexican Official Standard NOM-EM-005-CRE-2015: "Quality specifications for petroleum products" in order to prove the fulfilment of their obligations in 2016 On 30 October 2015, the Energy Regulatory Commission published in the Official Journal (DOF), on the basis of the texts mentioned, Emergency Mexican Official Standard NOM-EM-005-CRE-2015: "Quality specifications for petroleum products", which was amended pursuant to Resolution RES/898/2015, published in the DOF on 20 January 2016. Any comments should be addressed to: Secretaría de Economía Subsecretaría de Competitividad y Normatividad Dirección General de Normas Tel.: (+52) 55 5729 9100, Ext. 43244 Fax: (+52) 55 5520 9715 Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas Email: normasomc@economia.gob.mx and sofia.pacheco@economia.gob.mx Text available at: http://www.dof.gob.mx/nota_detalle.php?codigo=5483863&fecha=23/05/2017
Distribution date: 30 May 2017
Products Covered: Petroleum products (headings 27.01 to 2901.10) ;
Regulation Type: Addendum to Regular Notification
SI 54 - Bases for preparation of drinks
Distribution date: 29 May 2017 | Final date for Comment: 28 July 2017
The existing Mandatory Standard, SI 54, dealing with bases for preparation of drinks, shall be declared voluntary. This declaration is done to reduce the regulatory burden of manufacturers and importers and remove duplicate technical regulations.
Products Covered: Bases for preparation of drinks
Regulation Type: Regular notification
SI 1248 - Beverage powders having fruity or other flavours
Distribution date: 29 May 2017 | Final date for Comment: 28 July 2017
The existing Mandatory Standard, SI 1248, dealing with beverage powders having fruity or other flavours, shall be declared voluntary. This declaration is done to reduce the regulatory burden of manufacturers and importers and remove duplicate technical regulations.
Products Covered: Beverage powders having fruity or other flavours
Regulation Type: Regular notification
Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) Regulations
Distribution date: 24 May 2017
The proposed amendment notified in G/SPS/N/CAN/1040 (dated 14 July 2016) was adopted and published on 17 May 2017 as the Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) and Regulations Amending the Establishment Licensing Fees (Veterinary Drugs) Regulations. These regulations will come into force between November 2017 and July 2019. This measure was also notified under G/TBT/N/CAN/491 (dated 7 July 2016).
Products Covered:
Regulation Type: Addendum to Regular Notification
Amendment to the Enforcement Ordinance of the Food Sanitation Act and the Standards and Specifications for Foods and Food Additives
Distribution date: 24 May 2017
Revision of the existing standards and specifications for Asparaginase (A. oryzae NZYM-SP-derived), Sodium Selenite, Octanoic Acid, Peracetic Acid Composition, Hypobromous acid water, and 1-Hydroxyethylidene-1,1-diphosphonic acid (HEDP).
Products Covered: Food additive (Asparaginase (A. oryzae NZYM-SP-derived), Sodium Selenite, Octanoic Acid, Hypobromous acid water, and 1-Hydroxyethylidene-1,1-diphosphonic acid (HEDP)) and Food additive composition (Peracetic Acid Composition)
Regulation Type: Regular notification
DUS 1756-1:2017, Commercial blasting explosives — Specification — Part 1: Emulsion Explosive.
Distribution date: 24 May 2017 | Final date for Comment: 23 July 2017
This draft Uganda Standard specifies requirements, tests methods and sampling of emulsion explosives.
Products Covered: Commercial blasting explosives.
Regulation Type: Regular notification
The Draft Resolution n. º 311/2017, notified through G/TBT/N/BRA/707, was adopted as a final text, published as ANVISA Resolution – RDC nº 157, 11 May 2017. The full text is available only in Portuguese and can be downloaded at:
Distribution date: 22 May 2017
Products Covered: Medicines
Regulation Type: Addendum to Regular Notification
Proyecto de Reglamento que regula los estudios de estabilidad de las especialidades farmacéuticas
Distribution date: 19 May 2017 | Final date for Comment: 16 August 2017
El presente Reglamento tiene por objeto: - Establecer las normas que regulen el desarrollo de los estudios de estabilidad de las especialidades farmacéuticas. - Establecer la información que debe contener el documento requerido para la evaluación de los estudios de estabilidad en la inscripción, reinscripción o cambios en el registro sanitario de las especialidades farmacéuticas.
Products Covered: (HS code(s): 30)
Regulation Type: Regular notification
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