Partial revision of the Pharmaceutical Affairs Law, Enforcement Regulations (1 page, available in English)
Distribution date: 30 October 2009 | Final date for Comment: 23 December 2009
Partial revision of the Pharmaceutical Affairs Law, Enforcement Regulations to exclude the Plasters and Pressure Sensitive Adhesives Tapes contains diclofenac 1.9% or less from powerful drugs.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Decree of Minister of Industry No. 45/M-IND/PER/5/2009 on Mandatory Implementation of Indonesia National Standard for SNI 01-3747-1995, Cacao Powder (7 pages, in Indonesian)
Distribution date: 02 November 2009 | Final date for Comment: 01 January 2010
This Decree states that all Cacao Powder products produced within the country and imported, distributed and marketed in the country shall fulfil SNI requirements. The producer and / or importers therefore shall have a product certificate for the use of SNI Mark and comply with the requirements of SNI. The Product Certificate on SNI Marking shall be issued by a Product Certification Body which has been accredited by National Accreditation Body of Indonesia namely Komite Akreditasi Nasional (KAN) or appointed by Minister of Industry , through : ; a. System 5 of product certification (PSN 302-2006) : ; a. Testing of the conformity of the products quality against SNI requirements; ; b. Audit on the implementation of the Quality Management System (QMS) SNI 19-9001-2001/ISO 9001-2000 or its revision; or other recognized Quality Management system; and ; b. System 1b of product certification ((PSN 302-2006) : ; a. Domestic products : Testing of the conformity of the products quality against SNI requirements for every lot of production, every 3 months. ; b. Imported products : ; • Evaluation on document of : ; - Certificate of Analysis (CoA) of product against SNI requirements through testing conducted by testing laboratory which has an MoU arrangement with certification body in Indonesia; ; - Official report of sampling; or ; • Conduct sampling and testing according to SNI parameters by testing laboratories appointed by Product Certification Body. ; Directorate General of Agriculture and Chemical Based Industries, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a technical guidance of the decree, which covers Procedure of Product Certification and SNI Marking. ; Cocoa Powder which are distributed in domestic market that originated domestically and imported shall meet the requirements which consist in these standards as follows SNI 01-3747-1995. These standards specify the scope, term and definition, type, quality requirement, sampling, testing method, testing acceptance, marking requirement and packaging (these standards are available in Indonesian language) ;
Products Covered: Cocoa powder HS.1805.00.00.00
Regulation Type: Regular notification
"Portaria" n° 340, issued on 28 September 2009, published in the "Diário Oficial da União" Nº 188 (Federal Official Journal) from 1 October 2009, section 1, pages 4 to 9
Distribution date: 04 November 2009 | Final date for Comment: 29 December 2009
The notified document opens a 90-day public consultation on the draft proposal that establishes the official methods for inoculants analysis.
Products Covered: Inoculants
Regulation Type: Regular notification
Proposed Significant New Use Rules on Certain Chemical Substances (7 pages, English)
Distribution date: 10 November 2009 | Final date for Comment: 07 December 2009
EPA is proposing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of premanufacture notices. The two substances are identified generically as multi-walled carbon nanotubes (P-08-177) and single-walled carbon nanotubes (P-08-328). These substances are subject to TSCA section 5(e) consent orders issued by EPA. The consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs on these substances are based on and consistent with the provisions in the underlying consent orders. The proposed SNURs designate as a "significant new use'' the absence of the protective measures required in the corresponding consent orders. This action would require persons who intend to manufacture, import, or process either of these two substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. ;
Products Covered: Chemical Substances (HS 2803) (ICS 13.020, 71.100)
Regulation Type: Regular notification
TITLE: Hazard Communication; Correction ; ; AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor ; ; ACTION: Proposed rule: correction ; ; SUMMARY: This document corrects the OSHA Hazard Communication standard ; proposed rule and request for comment, published in the Federal Register of September 30, 2009. This notice corrects eight errors, four in the preamble and four that appear in Appendix A: Table A.1.1, Table A.1.2, Table A.2.3, and Table A7.1. ; ; Full text: ; http://edocket.access.gpo.gov/2009/E9-26579.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-26579.pdf ; ;
Distribution date: 10 November 2009 | Final date for Comment: 26 April 2025
Products Covered: Chemicals (HS: Chapter 29 ) (ICS: 13, 71)
Regulation Type: Corrigendum to Regular Notification
Draft Regulation Regarding the Production, Import, Marketing and Inspection Of Organic, Organomineral Fertilizers And Soil Amendment Products And Other Products, Microbial And Enzyme Based Products (37 Pages in Turkish and English)
Distribution date: 10 November 2009 | Final date for Comment: 09 January 2010
The Regulation covers the promotion, definition, maintaining of analysis methods, production, import, marketing and inspection of Organic, Organomineral Fertilizers, Soil Amendment Products and Other Products, Microbial and Enzyme Based Products in order to protect consumers, to improve soil fertility and quality, to protect human health and environment. The Regulation defines the norms, content and features of the products.
Products Covered: Organic, Organomineral Fertilizers, Soil Amendment Products, Microbial and Enzyme Based Products and Other Products (HS : 3101)
Regulation Type: Regular notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Extension of Comment Period ; ; AGENCY: Food and Drug Administration ; ; ACTION: Proposed Rule; extension of comment period ; ; SUMMARY: The Food and Drug Administration (FDA) is extending to 5 February 2010, the comment period for the proposed rule that appeared in the Federal Register of 23 September 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. ; ; DATES: Submit electronic or written comments by 5 February 2010. ; ; URL: ; http://edocket.access.gpo.gov/2009/E9-26966.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-26966.pdf ;
Distribution date: 19 November 2009 | Final date for Comment: 26 April 2025
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
Draft order of the DSSU “On amendments to the List of Goods Subject to Mandatory Certification in Ukraine” (5 pages, in Ukrainian).
Distribution date: 25 November 2009 | Final date for Comment: 24 January 2010
This draft of regulatory act establishes the mandatory certification of food products of plant origin and issuing of certificates of conformity with information concerning product’s safety in accordance with Ukrainian regulations.
Products Covered: Food products of plant origin (HS 0701, 0702 00 00 00, 0703, 0704, 0705, 0706, 0707 00, 0708, 0709, 0710, 0711, 0712, 0713, 0714, 0801, 0802, 0803 00, 0804, 0805, 0806, 0807, 0808, 0809, 0810, 0811, 0812, 0813)
Regulation Type: Regular notification
Proyecto de Resolución del Ministerio de la Protección Social "Por la cual se establece el reglamento técnico sobre los requisitos que deben cumplir las plantas especiales de beneficio de aves de corral y se dictan otras disposiciones" (Draft Resolution of the Ministry of Social Welfare "establishing the technical regulations on requirements for poultry slaughter and processing plants and adopting other provisions")
Distribution date: 26 November 2009 | Final date for Comment: 25 February 2010
The notified text sets forth the sanitary requirements for poultry slaughter and processing plants. It covers the following: Purpose; scope; definitions; sanitary standards; location and access; design and construction; drainage systems; ventilation; lighting; sanitary installations; liquid and solid waste management; water quality; product handlers and their state of health; training; hygienic practices and protective measures; requirements for slaughter and processing plant installations, equipment and tools; reception and slaughter area; reception section; slaughter section; scalding and plucking area; evisceration, cleaning, chilling and packaging area; evisceration, carcass-cleaning section; chilling and packaging section; other installations; sanitation standard operating procedures (development, implementation, maintenance, corrective actions, records, verification, and microbiological verification); sampling requirements; recording of test results; sampling plan criteria; microbiological criteria; sampling requirements; non-fulfilment of microbiological criteria; physico-chemical requirements; "zero tolerance" faecal matter control in slaughter and processing plant operations; preliminary sanitary inspection carried out on the farm; preliminary ante- and post-mortem inspection at the plant; official inspection of establishments engaged in the slaughter and processing of poultry; official inspection criteria; ante-mortem inspection; ante-mortem inspection at the plant; condemned/seized birds; final results of ante-mortem inspection; post-mortem inspection; examinations conducted during post-mortem poultry inspection; post-mortem inspection results and final destination of products; monitoring and control; review and updating; safety measures and penalty system; notification and period of validity.
Products Covered: Poultry
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Revision of Agricultural Chemical residue standards)
Distribution date: 04 December 2009 | Final date for Comment: 02 February 2010
Proposed maximum residue limits (MRLs) for Indoxacarb, Esprocarb, Trifloxystrobin, Prosulfocarb and Metalaxyl and Mefenoxam.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - Dairy and eggs (HS Codes: 04.01, 04.07 and 04.08) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.12, 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, 08.13 and 08.14) - Coffee, mate and spices (HS Codes: 09.01, 09.02, 09.03, 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, 10.06, 10.07 and 10.08) - Oleaginous fruits; miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.08, 12.10 and 12.12) - Residues and waste from the food industries (HS Code: 23.02)
Regulation Type: Regular notification
Submit your email ID to receive notifications about upcoming courses and events
