Chemical Regulatory Updates – Latest Global Changes

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

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

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

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

- 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

Revised Draft of the Philippine National Standard (PNS) on Natural Ingredients: Good Cultivation Practices (GCP) for Mushroom

Distribution date: 12 December 2016 | Final date for Comment: 15 February 2017

This Code addresses Good Cultivation Practices (GCP) for mushroom that will provide specific guidance to promote product safety and quality, ensure worker's health, safety, and welfare, and minimize occurrence of microbial, chemical and physical hazards associated with production of mushroom meant for human consumption.

Products Covered: Mushroom

Regulation Type: Regular notification

Food safety Human health

Commission Implementing Regulation (EU) 2016/2107 of 1 December 2016 amending Annex I to Regulation (EC) No 669/2009 as regards the list of feed and food of non-animal origin subject to an increased level of official controls on imports (Text with EEA relevance)

Distribution date: 12 December 2016 | Final date for Comment: 01 May 2025

This Regulation reviews the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls. The changes concern (i) the listing of the following items: groundnuts and derived products from Bolivia, Plurinational State of; pineapples from Benin; table grapes from Egypt; pomegranates from Turkey; sesamum seeds, aubergines and Ethiopian eggplant from Uganda; and (ii) the modification of the control frequency for the following items: pistachios from the United States of America, pitahaya (dragon fruit) from Viet Nam and lemons from Turkey.

Products Covered: HS Code(s): ex 07049090, ex 07081000, ex 07082000, 07096010, 07093000, ex 07094000, 07096010, ex 07096099, ex 07099990, ex 07102200, 07108051, ex 07108059, ex 07108095, 08022100, 08022200, 08025100, 08025200, 08043000, 08055010, 08061010, 08101000, ex 08109020, ex 08109075, 08112031, ex 08112011, ex 08112019, 08131000, 0902, ex 11063090, 12024100, 12024200, 12074090, ex 12077000, ex 12119086, 15111090, 15119011, ex 15119019, 15119099, 20081110, 20081191, 20081196, 20081198, 20085061, ex 20089999, 3507

Regulation Type: Regular notification

Food safety Human health

<a name="spsTitle">Acuerdo De La Comisión Reguladora de Energía que Aprueba la Convocatoria para que los Laboratorios de Ensayo o Prueba, Radicados en el Extranjero Obtengan el Registro para Evaluar la Conformidad de la Norma Oficial Mexicana Nom-016-Cre-2016, Especificaciones de Calidad de los Petrolíferos, Publicada en el Diario Oficial de la Federación el 29 De Agosto De 2016</a>El 12 de agosto de 2016, la Comisión Reguladora de Energía publicó las respuestas a los comentarios recibidos sobre el Proyecto de Norma Oficial Mexicana PROY-NOM-016-CRE-2016, Especificaciones de calidad de los petrolíferos, publicándose como norma definitiva el 29 de agosto de 2016.Cualquier comentario dirigirlo a: Secretaría de EconomíaSubsecretaría de Competitividad y NormatividadDirección General de NormasTel:  (+52) 55 5729 9100 Ext. 43244Fax:  (+52) 55 5520 9715Sitio internet:  <a href="http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas">http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogo-mexicano-de-normas</a>Correo electrónico:  <a href="mailto:[email protected]">[email protected]</a>y <a href="mailto:[email protected]">[email protected]</a>Y está disponible en:<a href="http://www.dof.gob.mx/nota_detalle.php?codigo=5464596&fecha=08/12/2016">http://www.dof.gob.mx/nota_detalle.php?codigo=5464596&fecha=08/12/2016</a><a href="http://www.dof.gob.mx/nota_detalle.php?codigo=5464596&fecha=08/12/2016"></a>

Distribution date: 16 December 2016 | Final date for Comment: 01 May 2025

Products Covered: Petroleum products (headings 27.01 to 2901.10) ;

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: 19 December 2016 | Final date for Comment: 17 February 2017

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Spirotetramat.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06 and 02.08) - 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, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 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 Codes: 09.01, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.07 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 19 December 2016 | Final date for Comment: 17 February 2017

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Thifensulfuron methyl.

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Code: 08.14) - Coffee, tea, mate and spices (HS Codes: 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.07 and 12.12)

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

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

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

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

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

- 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).

Revised Draft of the Philippine National Standard (PNS) on Natural Ingredients: Good Cultivation Practices (GCP) for Mushroom

Commission Implementing Regulation (EU) 2016/2107 of 1 December 2016 amending Annex I to Regulation (EC) No 669/2009 as regards the list of feed and food of non-animal origin subject to an increased level of official controls on imports (Text with EEA relevance)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)