Regulatory Updates

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

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

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

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

Distribution date: 16 February 2009

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

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

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

Distribution date: 13 February 2009 | Final date for Comment: 14 April 2009

The notified Technical Regulation establishes the Maximum Residue Limits (MRLs) authorized at national level for pesticides and their metabolites in the various plant crops for human and animal consumption.

Products Covered: International Classification for Standards (ICS) Code 65.100

Regulation Type: Regular notification

Distribution date: 11 February 2009

Products Covered: Wood products (HS 44, 4408, 4410, 4411, 4412) (ICS 790.060, 79.080, 79.040, 79.020, 13.020, 91) ;

Regulation Type: Addendum to Regular Notification

Distribution date: 06 February 2009

This draft Decree states that all Refined Sugar 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) 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 Certificate of Analysis (CoA) of product against SNI requirements; or sampling and testing of products by testing laboratories appointed by certification body. ; 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, or appointed by The Minister of Industry, Republic of Indonesia. ; 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. ; Refined Sugar products which are distributed in domestic market that originated domestically and imported shall meet the requirements which consist in the standard as follows SNI 01-3140.2-2006, HS.1701.99.11.00 and HS. 1701.99.19.00. This standard specifies the scope, term and definition, type, quality requirements, sampling, testing method, testing acceptance, marking requirement and packaging (this standard is available in Indonesian language) ;

Products Covered: Refined Sugar (HS.1701.99.11.00; HS. 1701.99.19.00)

Regulation Type: Regular notification