"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
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
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
Proposed amendment of Safety Criterion for consumer products subject to the self-regulatory safety confirmation (Korean)

Distribution date: 28 October 2009 | Final date for Comment: 27 December 2009
KATS will: ; The safety standard of 'Adhesives' subject to Self-regulatory Safety Confirmation has been revised. ; - 'Adhesives for Wigs' to the category of adhesives which are the item for Self-regulatory Safety Confirmation applied additionally. ; - As to the safety standards for harmful material of adhesives for wigs - Newly prescribed the regulation to prohibit the use of Triphenyltin (TPT) compounds, Tributyltin (TBT) ; compounds, and organomercury compounds, and to limit the use of toluene and formaldehyde to 20 mg/kg or less. ; - Lowered the allowable standard for the content of toluene in adhesives for general consumers from 10% to 0.1%, but 10% for adhesives for professionals maintained at the current level. ; - It is newly prescribed that the allowable standard for the content of formaldehyde in adhesives should be smaller than 1.0%. ;
Products Covered: Adhesives (HS: 3506)
Regulation Type: Regular notification
TITLE: Current Good Manufacturing Practice Requirements for Combination Products ; ; AGENCY: Food and Drug Administration (FDA) ; ; ACTION: Correction ; ; SUMMARY: The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of September 23, 2009 (74 FR 48423). The document proposed to codify the current good manufacturing practice requirements applicable to combination products. The document published with an incorrect docket number. This document corrects that error. ; ; The correct Docket number is: [Docket No. FDA-2009-N-0435]. ; ; FOR FURTHER INFORMATION CONTACT: ; Joyce Strong ; Office of Policy (HF-27) ; Food and Drug Administration ; 5600 Fishers Lane ; Rockville, MD 20857 ; Telephone: 301-827-7010 ; ; Full texts: ; http://edocket.access.gpo.gov/2009/E9-23899.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-23899.pdf ;

Distribution date: 28 October 2009
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Corrigendum to Regular Notification
Interim Marketing Authorization regarding the use of the phospholipase A2 enzyme derived from Aspergillus niger (PLA-54) in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin

Distribution date: 21 October 2009 | Final date for Comment: 24 December 2009
Health Canada has received a submission to permit the use of the phospholipase A2 enzyme derived from a genetically modified Aspergillus niger strain, Aspergillus niger (PLA-54), that carries the gene from a porcine pancreas coding for this enzyme. Phospholipase enzymes are classified under the broad class of lipase enzymes. This phospholipase A2 enzyme will be used in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin, at levels consistent with good manufacturing practice. Evaluation of the available data supports the safety and effectiveness of this phospholipase A2 derived from the genetically modified Aspergillus niger (PLA-54). Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of this phospholipase A2 enzyme derived from Aspergillus niger (PLA-54) in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin, at levels consistent with good manufacturing practice. As a means to improve the responsiveness of the regulatory system, an Interim Marketing Authorization is being issued to permit the immediate use of this phospholipase A2 enzyme, as indicated above, while the regulatory process is undertaken to amend the Regulations. The proposed regulatory amendments would be enabling measures to allow the sale of the foods mentioned above that have been manufactured through the use of the phospholipase A2 enzyme derived from Aspergillus niger (PLA-54). The amendments are supported by the safety assessment and would have low impact on the economy and on the environment. Consequently, the regulatory amendments may proceed directly to final approval and publication in the Canada Gazette, Part II.
Products Covered: Bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin (ICS Codes: 67.060, 67.120)
Regulation Type: Regular notification
Proposed amendments to Standards & Specifications for Food-Contact Surface Sanitizing Solution

Distribution date: 16 October 2009 | Final date for Comment: 15 December 2009
To strengthen the safety management system for food-contact surface sanitizing solution, the proposed regulation removes 11 chemical agents from the list of ingredients for sanitizing solution formulation, integrates three analogues into one compound, and allows one additional substance for use. To clarify the scope of application of chemical compounds allowed for use in manufacturing sanitizing solution, chemical names of "silver" and "α-Alkyl(C11-C15)-ω-hydroxypoly(oxyethylene)with ethylene oxide content 9 to 13moles" are revised. The regulation also revises general standards for permitted the use of sanitizing solution.
Products Covered: Food-contact surface sanitizing solution
Regulation Type: Regular notification
Medida de carácter sanitario, requisitos fisicoquímicos y microbiológicos que deben cumplir los productos de la pesca

Distribution date: 08 October 2009 | Final date for Comment: 06 January 2010
Fish, molluscs and crustaceans
Products Covered:
Regulation Type: Addendum to Regular Notification
"Portaria" n° 325, issued on 14 September 2009, published in the "Diário Oficial da União" Nº 178 (Federal Official Journal) from 17 September 2009, section 1, pages 4 to 9

Distribution date: 07 October 2009 | Final date for Comment: 15 November 2009
The notified document opens a 60-day public consultation on the draft proposal that establishes the rules regarding specifications, guarantees, registry, packaging and labelling of inoculants for use in agriculture.
Products Covered: Inoculants for use in agriculture
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: 07 October 2009 | Final date for Comment: 06 December 2009
Proposed maximum residue limits (MRLs) for isotianil, fentrazamide and boscalid.
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: 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, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) ・ Cereals (HS Codes: 10.03 and 10.06) ・ Oleaginous fruits; miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02 12.05, 12.06 and 12.10) ・ Vegetable oil (HS Codes: 15.08 and 15.14)
Regulation Type: Regular notification
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