Draft of Monograph for Vitamin and Mineral Pharmaceutical Products Review and Approval

Distribution date: 13 February 2009 | Final date for Comment: 14 April 2009
The amendment of this draft is to regulate the daily dosage limitation, classification and indications of the vitamin and mineral products made by single or complex, orally-taken pharmaceutical form.
Products Covered: Orally-taken vitamin and mineral products
Regulation Type: Regular notification
Proposed Amendments to Air Pollution Control Regulation No. 44 Control of Volatile Organic Compounds from Adhesives and Sealants

Distribution date: 16 February 2009 | Final date for Comment: 20 February 2009
Revises rules pertaining to the control of volatile organic compounds from adhesives and sealants. Limits the VOC content of 40 categories of adhesive and sealant products.
Products Covered: Adhesives, sealants (HS 3506) (ICS 91.100, 13.040, 13.020)
Regulation Type: Regular notification
Modificación del Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo, Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola (G/SPS/N/CRI/48)

Distribution date: 16 February 2009 | Final date for Comment: 25 April 2025
Reglamento sobre Registro, Uso y Control de Plaguicidas Sintéticos Formulados, Ingrediente Activo Grado Técnico, Coadyuvantes y Sustancias Afines de Uso Agrícola. ICS 65.100.
Products Covered:
Regulation Type: Addendum to Regular Notification
Proyecto de Resolución de la Secretaría General de la Comunidad Andina "Norma Sanitaria Andina para el comercio y la movilización intrasubregional y con terceros países de aves y sus productos" (Draft Resolution of the Andean Community General Secretariat "Andean health standard governing trade in and movement of poultry and poultry products at intra-subregional level and with third countries")

Distribution date: 19 February 2009 | Final date for Comment: 24 March 2009
(cont'd)eggs, not in shell, and egg yolks, fresh, dried, cooked by steaming or by boiling in water, moulded, frozen or otherwise preserved, whether or not containing added sugar or other sweetening matter; meat and edible offal of fowls of the species Gallus domesticus, ducks, geese, turkeys and guinea fowls, fresh, chilled or frozen; poultry fat not rendered or otherwise extracted; sausages and similar products, of meat, meat offal or blood; food preparations based on these products, of fowls of the species Gallus domesticus, ducks, geese and turkeys and other prepared or preserved meat, meat offal or blood; products of avian origin destined for use in animal feeding, or for agricultural or industrial use; and final provisions.
Products Covered: Poultry and poultry products (HS tariff subheadings 0105.94.00, 0105.99.00, 0106.39.00, 0105.11.00, 0105.12.00, 0105.19.00, 0106.39.00, 0106.32.00, 0106.39.00, 0511.99.30, 0407.00.10, 0407.00.20, 0407.00.90, 0408.11.00, 0408.19.00, 0408.91.00, 0408.99.00, 0207.11.00, 0207.1200, 0207.13.00, 0207.13.10, 0207.13.90, 0207.14.00, 0207.14.10, 0207.14.90, 0207.24.00, 0207.25.00, 0207.32.00, 0207.33.00, 0207.34.00, 0207.35.00, 0207.36.00, 0209.00.90, 1601.00.00, 1602.00.00, 0505.10.00, 0507.90.00, 3101.00.90 and 0511.99.90)
Regulation Type: Regular notification
Resolution No. 351 of 31 December 2008 "Partially amending Resolution No. 355/08 concerning provisions of the Regulations on the control of agricultural pesticides, approved by Resolution No. 446/06" (3 pages, in Spanish).

Distribution date: 19 February 2009 | Final date for Comment: 20 April 2009
The notified Resolution extends the deadline for the implementation of the mandatory registration revalidation process, with regard to the elements to be submitted pursuant to Resolution No. 355/08 and subject to their assessment, and also grants, subject to an assessment, temporary registration to institutions which do not as yet have the product reference profile required for registration by equivalency until 30 June 2010. The Resolution also establishes 30 June 2009 as the expiry date for all registrations granted under Resolution No. 1000/94.
Products Covered: Agrochemicals falling under MERCOSUR Common Nomenclature (NCM) tariff heading 3808
Regulation Type: Regular notification
Draft decree of Ministry of Industry on Mandatory Implementation of Indonesia National Standard for SNI 7322:2008, Melamine products – food and drink appliances.

Distribution date: 27 February 2009 | Final date for Comment: 28 April 2009
This draft Decree states that all melamine products – food and drink appliances 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 Marking and comply with the requirements of SNI, as well as put SNI mark to their products. 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 the Minister of Industry through : ; 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. ; The testing shall be carried out by testing laboratories which have been accredited by KAN or accredited by an accreditation body which has signed Mutual Recognition Arrangement (MRA) with KAN, and have the bilateral or multilateral agreement on regulation between Indonesia and particular country. ; 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. ; Melamine products – food and drink appliances which are distributed in domestic market that originated domestically and imported shall meet the requirements which consist in the standard as follows SNI 7322:2008, HS.3924.10.00.00. This standard specifies the scope, term and definition, type, quality requirements, sampling, testing methods, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language). ;
Products Covered: Melamine products – food and drink appliances (HS.3924.10.00.00)
Regulation Type: Regular notification
Interim Marketing Authorization regarding the use of the phospholipase A2 enzyme in the production of bread, flour, whole wheat flour, unstandardized bakery products, unstandardized whole egg, unstandardized egg yolk and modified lecithin

Distribution date: 06 March 2009 | Final date for Comment: 14 May 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 another strain of Aspergillus niger 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, 67.220)
Regulation Type: Regular notification
Oven cleaners and grease removers for domestic use: Safety, packaging and marking requirements (8 pages, in Hebrew)

Distribution date: 09 March 2009 | Final date for Comment: 24 April 2009
The requirements of the existing standard SI 4272 part 1, dealing with oven cleaners and grease removers for domestic use, will be declared mandatory.
Products Covered: Oven cleaners and grease removers for domestic use (ICS: 71.100.40; HS: 3402)
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: 10 March 2009 | Final date for Comment: 09 May 2009
Proposed maximum residue limits (MRLs) for flucetosulfron, acetamiprid, cadusafos, thiamethoxam, clothianidin, 1-naphthaleneacetic acid, fenbuconazole, eprinomectin and etiproston.
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) ・ 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, 07.13 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, tea, mate and spices (HS Codes 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09, 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, 12.11, 12.12 and 12.14)
Regulation Type: Regular notification
La República de Colombia comunica con relación al proyecto de "(…) reglamento técnico sobre requisitos que deben cumplir los detergentes polvos limpiadores abrasivos de uso doméstico" del Ministerio de la Protección Social, notificado el 23 de mayo de 2003 por la Organización Mundial del Comercio mediante el documento identificado con la signatura G/TBT/N/COL/39, que éste ha sido expedido el 19 de junio de 2007, mediante la Resolución Nº 1974 del Ministerio de la Protección Social. ; ; Texto disponible en el Ministerio de Comercio, Industria y Turismo, Dirección de Regulación, Organismo Nacional encargado de la Notificación: ; ; Punto de Contacto ; Responsable: Daniel Héctor Rico R. ; Calle 28 Nº 13A - 15, tercer piso ; Bogotá, D.C., Colombia ; Email: [email protected] ; Tel: +(571) 6067676, Ext.1690 ; Fax: +(571) 2410480 ;

Distribution date: 11 March 2009 | Final date for Comment: 25 April 2025
Products Covered: Scouring powders (340540)
Regulation Type: Addendum to Regular Notification
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