Chemical Regulatory Updates – Latest Global Changes

- Proposed Amendments to the Act and its enforcement decree and rule on Promotion of Environment-friendly Agriculture and Fisheries, and Management of and Support for Organic Foods (46 pages, in Korean; 13 pages, in Korean; 79 pages, in Korean).

Distribution date: 01 December 2016 | Final date for Comment: 30 January 2017

<a name="sps6a">The main amended contents in this document are as follows:</a>A.  Proposed Amendments to the Act on Promotion of Environment-friendly Agriculture and   Fisheries, and Management and Support for Organic Foods-    - The private certification body alone will conduct certification process which was previously conducted          by both private certification body and National Agricultural Products Quality Management Service(NAQS) for the sake of fairness and equity of certification body(Article 20.1, 34.3)- Separate labeling of organic food will be allowed for the sake of organic food export promotion(Article 23.3.2,3, New Act)- The official notice and quality certification system of organic agricultural and fisheries material will be integrated into ?official notice? system only(Article 37.2, 42)B. Proposed Amendments to the enforcement decree of the act on Promotion of Environment-friendly Agriculture and Fisheries, and Management of and Support for Organic Foods   - Administrative authority will be commissioned to the National Agricultural Products Quality Management Service(NAQS) for the sake of consistent management of accreditation system and approved material(including organic agricultural material)( Article 5.2.,3) C.  Proposed Amendments to the enforcement  rule  of  the Act on Promotion of Environment-        friendly Agriculture and Fisheries, and Management and Support for Organic Foods, etc. under        ministry of agriculture, food and rural affairs   - Amendment of approved material selection standard and procedure and change to notice with regard to approved material listed in Annex 1(draft Article 3.1, 3.2, Annex 1, 2) - Streamline documents required for renewal(draft Article 16)  - Organic agriculture material management regulation(draft Article 67)- Change to notice with regard to details of organic and agricultural chemicals-free certification standard(draft Annex3, 11)

Products Covered: Environment-friendly agricultural and fishery products, processed organic foods and materials for organic farming

Regulation Type: Regular notification

Food standards

Regulation on Monitoring and Re-evaluation of Medical Device Adverse Event (17 pages, in Chinese)

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

Rules About the Medical Device Adverse Event Monitoring and Re-evaluation Management.

Products Covered: Medical devices

Regulation Type: Regular notification

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

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Regulatory Updates

- Proposed Amendments to the Act and its enforcement decree and rule on Promotion of Environment-friendly Agriculture and Fisheries, and Management of and Support for Organic Foods (46 pages, in Korean; 13 pages, in Korean; 79 pages, in Korean).

Regulation on Monitoring and Re-evaluation of Medical Device Adverse Event (17 pages, in Chinese)

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)