Chemical Regulatory Updates – Latest Global Changes

Public Notice under the Commodity Inspection Act (4 pages, in English; 3 pages, in Chinese)

Distribution date: 17 November 2016 | Final date for Comment: 16 January 2017

Self-ballasted fluorescent lamps (hereinafter "the commodities") have been subject to mandatory inspection under the Commodity Inspection Act by the Bureau of Standards Metrology and Inspection (BSMI) since 1 March 2001. In order to encourage industries to reduce the use of chemical substances in electric products and, more importantly, to raise consumers' concerns on effective utilization of resources to reduce the environmental burden, the BSMI proposes that the manufactures or importers shall follow the requirements stipulated in Section 5 "Marking of presence" of CNS 15663 and clearly mark "the presence conditions of the restricted substance(s)" on the body, packages, stickers, or the instruction books of the commodities. Those who utilize website as a means to announce "the presence conditions of the restricted substance(s)" of the commodities shall also clearly mark the website address on the body, packages, stickers, or the instruction books of the commodities. In addition, the BSMI intends to revise the Description of Goods of the commodities and adopt the revised standards CNS 14125 and CNS 14115, which were promulgated on 10 June 2014 and 4 March 2009 respectively.The conformity assessment procedures remain the same, i.e. Registration of Product Certification (RPC) or Type Approval Batch Inspection (TABI).

Products Covered: Self-ballasted fluorescent lamps (HS: Chapter 85)

Regulation Type: Regular notification

Proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 (3 pages, in English; 3 pages, in French)

Distribution date: 16 November 2016 | Final date for Comment: 15 January 2017

The Prohibition of Certain Toxic Substances Regulations, 2012 (the Prohibition Regulations) is a multi-substance regulation that prohibits, with a limited number of exemptions, the manufacture, use, sale, offer for sale, and import of toxic substances and products containing some of these substances. The proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 (the proposed Amendments) would amend the Prohibition Regulations to modify existing controls on Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST). Overview of the proposed Amendments:BNSTThe proposed Amendments would add an exemption to Part 1 of Schedule 2 of the Prohibition Regulations allowing the manufacture, import, use, sale and offer for sale of BNST used as an additive in lubricants found in replacement parts.In addition, the proposed Amendments would extend the temporary exemption for BNST used as an additive in lubricants in Part 2 of Schedule 2 of the Prohibition Regulations, thereby allowing the manufacture, import, sale and offer for sale of BNST used as an additive in lubricants until 14 March 2025. The proposed Amendments would allow manufacturers and importers of BNST and products containing BNST to apply for a permit to continue their activities after the expiry of the temporary exemption for additives in lubricants. Permits are valid for one year and can potentially be renewed twice allowing manufacturers and importers to continue their activities for an additional three years ending on 14 March 2028.

Products Covered: Standards and technical regulations pertaining to environmental protection (HS Code 29038990, ICS code 13.020)

Regulation Type: Regular notification

Notification of revision of the Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control

Distribution date: 14 November 2016

MAFF was proposing revision of the Article 45 of the "Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control" to add milk products to the list of items subject to animal quarantine in the notification G/SPS/N/JPN/471. The revision(*) of the "Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control" was published in Japanese Official Gazette on 31 October 2016. The revision will enter into force on 1 November 2017. Animal Health Requirements are still in preparation to set out detailed import conditions for milk products including required statements in the health certificate based on the import risk analysis and Chapters 8.8.24, 8.8.25, 8.8.35 and 8.8.36 of the OIE Terrestrial Animal Health Code (the OIE Code). MAFF will duly notify WTO Members once draft Animal Health Requirements have been developed. (*) MAFF revised the Article 45 in the "Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control (No. 35, 1951)" as attached: http://members.wto.org/crnattachments/2016/SPS/JPN/16_4725_00_e.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Proyecto de Resolución del Instituto Colombiano Agropecuario - ICA "Por medio de la cual se establecen los requisitos para el registro de productores, empacadores, envasadores o que estas actividades se realicen por contrato; así como los importadores, importadores para consumo propio, unidades de evaluación agronómica de ensayos de eficacia, de fertilizantes y/o acondicionadores de suelos. Así mismo se establecen los requisitos para el registro de fertilizantes y/o acondicionadores de suelo y se establecen otras disposiciones" (Draft Colombian Agricultural Institute (ICA) Resolution establishing registration requirements for producers, packers (including sub-contractors), importers, persons importing for their own consumption, and agronomic assessment units conducting fertilizer and/or soil conditioner efficacy trials. It also establishes registration requirements for fertilizers and/or soil conditioners and other provisions)

Distribution date: 11 November 2016 | Final date for Comment: 10 January 2017

The notified text establishes registration requirements for producers, packers (including sub-contractors), importers, persons importing for their own consumption, and agronomic assessment units conducting fertilizer and/or soil conditioner efficacy trials. It also establishes registration requirements for fertilizers and soil conditioners and covers the following aspects: Purpose; Scope; Definitions; Registration requirements; General requirements; Specific requirements; Registration procedure; Technical visits; Issue of registration certificates; Period of validity of registration; Changes to registration; Cancellation of registration; Fertilizers and/or soil conditioners subject to efficacy trials; Documents needed for the approval of efficacy trials; Efficacy trial formalities; Protocol approval; Conducting of trials; Importation of samples for experiments; Obligations; Prohibitions; Annexes; Transitional provisions; Penalties and period of validity.

Products Covered: Fertilizers and/or soil conditioners.

Regulation Type: Regular notification

Plant health

Public Notice under the Commodity Inspection Act (2 pages, in English; 2 pages, in Chinese)

Distribution date: 07 November 2016 | Final date for Comment: 06 January 2017

<div style="text-align:left;">Gas cylinders and the fuel thereof for portable gas stoves, blowtorches and refillable lighters are subject to mandatory inspection under the certification system of the Bureau of Standards, Metrology and Inspection (BSMI). The BSMI intends to adopt the revised version of CNS 14530 ''Gas cylinders for portable gas cooker'' (announced on 8 April 2014) as the testing and inspection standard.The conformity assessment procedure for the gas cylinders and the fuel thereof for portable gas stoves, blowtorches and refillable lighters remains unchanged, i.e. Type Approved Batch Inspection (TABI) Scheme. </div>

Products Covered: Gas cylinders and the fuel thereof for portable gas stoves, blowtorches and refillable lighters (refer to attachment)

Regulation Type: Regular notification

DUS 1578-1:2016, Pillows for domestic use - Specification - Part 1: Synthetic fibre filled (16 pages, in English)

Distribution date: 04 November 2016 | Final date for Comment: 02 January 2017

This Draft Uganda standard specifies the requirements and methods of testing for synthetic-fibre filled pillow for domestic use.

Products Covered: Pillows for domestic use, Synthetic fibre filled pillows for domestic use

Regulation Type: Regular notification

DUS 1578-2:2016, Pillows for domestic use - Specification - Part 2: Plumage- filled. (20 pages, in English)

Distribution date: 04 November 2016 | Final date for Comment: 02 January 2017

This Draft Uganda standard specifies the requirements and methods of testing for plumage filled pillows for domestic use

Products Covered: Pillows for domestic use, Plumage filled pillows for domestic use

Regulation Type: Regular notification

Receipt of a Pesticide Petition Filed for Residues of a Pesticide Chemical in or on a Commodity, Notice of Filing of Petition and Request for Comment

Distribution date: 04 November 2016 | Final date for Comment: 28 November 2016

This document announces the Agency's receipt of an initial filing of a pesticide petition requesting the amendment of the tolerance for residues of the fungicide, propamocarb hydrochloride, in or on potato from 0.06 parts per million (ppm) to 0.30 ppm.

Products Covered: Potato

Regulation Type: Regular notification

Food safety Pesticides Maximum residue limits (MRLs) Human health

Proyecto de Resolución del Ministerio de Salud y Protección Social "Por la cual se establece el reglamento técnico sobre los requisitos que debe contener la etiqueta de los reactivos in vitro para investigación, in vitro huérfanos para diagnóstico, in vitro grado analítico, analito específico, y los reactivos de uso general en laboratorio, que sean utilizados en muestras de origen humano" (5 páginas, en español).

Distribution date: 28 October 2016 | Final date for Comment: 27 December 2016

Se establecen los requisitos que debe cumplir la etiqueta de los reactivos in vitro para investigación, in vitro huérfanos para diagnóstico, in vitro grado analítico, analito específico y los reactivos de uso general en laboratorio; Objeto y ámbito de aplicación; Definiciones; Requisitos generales de la etiqueta; Requisitos específicos de la etiqueta; Declaración de la conformidad; Procedimiento de evaluación de la conformidad; Autorización para el agotamiento de existencias de etiquetas y uso de adhesivos; Revisión y actualización; Inspección, Vigilancia y Control y Vigencia.

Products Covered: Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes (HS code(s): 300210); Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; toxins, cultures of micro-organisms and similar products (excl. yeasts and vaccines) (HS code(s): 300290); Reagents for determining blood groups or blood factors (HS code(s): 300620); Culture media specially prepared for the development of micro-organisms (HS code(s): 3821); Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, and certified reference materials (excl. compound diagnostic reagents designed to be administered to the patient, blood-grouping reagents, animal blood prepared for therapeutic, prophylactic or diagnostic uses and vaccines, toxins, cultures of micro-organisms and similar products) (HS code(s): 3822)

Regulation Type: Regular notification

Labelling

; ; ;By means of this Addendum No. 4, the Republic of Ecuador advises that Amendment No. 3 to Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 088 "Surface tension agents", notified in document G/TBT/N/ECU/106/Add.1 of 24 October 2014, has been issued pursuant to Resolution No. 16 361 of 1 September 2016 of the Under-Secretariat for the Quality System of the Ministry of Industry and Productivity, published in Official Journal No. 859 of 11 October 2016. ;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: Marlon Martínez B. ;Yánez Pinzón N26-12, entre Av. Colón y La Niña ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358/2255 ;Email: PuntocontactoOTCECU@mipro.gob.ec/mmartinez@mipro.gob.ec ; ;

Distribution date: 26 October 2016

Products Covered: 34.01.11.00, 34.01.19.00, 34.01.19.10, 34.01.19.90, 34.01.20.00, 34.01.30.00, 34.02.11.10, 34.02.11.90, 34.02.12.10, 34.02.12.90 and 34.02.13.10. ;

Regulation Type: Addendum to Regular Notification

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Regulatory Updates

Public Notice under the Commodity Inspection Act (4 pages, in English; 3 pages, in Chinese)

Proposed Regulations Amending the Prohibition of Certain Toxic Substances Regulations, 2012 (3 pages, in English; 3 pages, in French)

Notification of revision of the Ministerial Ordinance for Enforcement of the Act on Domestic Animal Infectious Disease Control

Public Notice under the Commodity Inspection Act (2 pages, in English; 2 pages, in Chinese)

DUS 1578-1:2016, Pillows for domestic use - Specification - Part 1: Synthetic fibre filled (16 pages, in English)

DUS 1578-2:2016, Pillows for domestic use - Specification - Part 2: Plumage- filled. (20 pages, in English)

Receipt of a Pesticide Petition Filed for Residues of a Pesticide Chemical in or on a Commodity, Notice of Filing of Petition and Request for Comment