Regulatory Updates

Distribution date: 10 November 2009

Products Covered: Chemicals (HS:  Chapter 29 ) (ICS:  13, 71)

Regulation Type: Corrigendum to Regular Notification

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

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

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

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

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

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

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

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

Distribution date: 08 October 2009 | Final date for Comment: 06 January 2010

Fish, molluscs and crustaceans

Products Covered:

Regulation Type: Addendum to Regular Notification