Chemical Regulatory Updates – Latest Global Changes

Regulation on Administration of Medical Device Recall (14 pages, in Chinese)

Distribution date: 30 November 2016 | Final date for Comment: 29 January 2017

This regulation is about the administration of medical device recall. It includes which agency will be responsible for medical device recall, how to initiate a recall, the procedures, and legal responsibility, etc..

Products Covered: Medical devices

Regulation Type: Regular notification

Provisions for In-vitro Diagnostic Reagent Registration Amendment (1 page, in Chinese)

Distribution date: 30 November 2016 | Final date for Comment: 29 January 2017

In the Supplementary Articles of these Provisions, a new article "the classification principle defined by the 17th and 18th articles of these provisions can be amended by China Food and Drug Administration according to the actual conditions" is proposed to be added.

Products Covered: Medical devices

Regulation Type: Revision to Regular Notification

Human health

Catalog on Medical Device Classification (Revised Edition) (156 pages, in Chinese)

Distribution date: 28 November 2016 | Final date for Comment: 31 January 2017

Following the Rules for Classification of Medical Devices (Decree No. 15 of China Food and Drug Administration), Catalog on Medical Device Classification  (Revised Edition) is a normative document combining intended purpose, structural characteristics, pattern of use, and other related factors so as to determine the risk degree of medical devices. Catalog on Medical Device Classification (Revised Edition) contains 22 subdirectories including active surgical categories, 205 first level categories of products, 1136 second level product categories and 5641 typical examples of product names. This catalog does not contain the content of Classification Catalog on 6840 Vitro Diagnostic Products (2013 Edition), medical device kit or non-medical device product.

Products Covered: Medical devices

Regulation Type: Regular notification

Human health

Provision for Classification Adjustment of Allergen and other Three Kinds of In-vitro Diagnostic Reagents (28 pages, in Chinese)

Distribution date: 28 November 2016 | Final date for Comment: 27 January 2017

According to the actual requirements of registration management of IVD, it adjusts the classification of some kinds of allergen reagents, Immunohistochemical reagents, and the Reagents match up the flow cytometry.

Products Covered: Medical devices

Regulation Type: Regular notification

DKS 317: PART 1: 2015 Carcasses and meat cuts - Specification - Part 1: Bovine - Section 1: Beef, Section 2: Veal (20 pages, in English)

Distribution date: 22 November 2016 | Final date for Comment: 09 January 2017

This standard specifies methods of grading and grades of beef, quality requirements, safety requirement and methods of sampling and analysis of beef carcasses and cuts meant for human consumption. The standard also defines major portions of meat cuts from the carcasses for sale.

Products Covered: (HS code(s): 0201, 0202); Meat, meat products and other animal produce (ICS code(s): 67.120)

Regulation Type: Regular notification

Food standards

DKS 317: PART 2:2015 Carcasses and meat cuts - Specification - Part 2: Ovine and Caprine - Section 1: Lamb and mutton, Section 2: Goat (18 pages, in English)

Distribution date: 22 November 2016 | Final date for Comment: 09 January 2017

The standard specifies methods of grading and grades of lamb and mutton, quality requirements, safety requirement and methods of sampling and analysis of lamb and mutton carcasses and cuts meant for human consumption.

Products Covered: (HS code(s): 0204); Meat, meat products and other animal produce (ICS code(s): 67.120)

Regulation Type: Regular notification

Food standards

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

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Regulation on Administration of Medical Device Recall (14 pages, in Chinese)

Provisions for In-vitro Diagnostic Reagent Registration Amendment (1 page, in Chinese)

Catalog on Medical Device Classification (Revised Edition) (156 pages, in Chinese)

Provision for Classification Adjustment of Allergen and other Three Kinds of In-vitro Diagnostic Reagents (28 pages, in Chinese)

DKS 317: PART 1: 2015 Carcasses and meat cuts - Specification - Part 1: Bovine - Section 1: Beef, Section 2: Veal (20 pages, in English)

DKS 317: PART 2:2015 Carcasses and meat cuts - Specification - Part 2: Ovine and Caprine - Section 1: Lamb and mutton, Section 2: Goat (18 pages, in English)

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