Regulatory Updates
1. Health Canadas Proposal to Amend the Food and Drug Regulations to Permit the Use of the Enzyme Asparaginase Sourced From Aspergillus oryzae (pCaHj621/BECh2#10) in Certain Food Products December 2009 2. Health Canadas Proposal to Amend the Food and Drug Regulations to Permit the Use of a Second Source (Aspergillus niger ASP72) of the Enzyme Asparaginase in Certain Food Products December 2009
Distribution date: 15 December 2009 | Final date for Comment: 21 February 2010
In Canada, enzymes used in food applications, such as asparaginase, may be considered food additives, depending on their conditions of use. Permitted food additives are listed in the food additives tables in Division 16 of the Food and Drug Regulations. Health Canada has received two food additive submissions seeking the approval of the enzyme asparaginase for use in the manufacture of various standardized and unstandardized foods. The food products covered by the first submission are: wheat dough-based products such as bread, crackers and cookies; cut potato products such as French fries; sliced potato products; and fabricated potato chips. The food products covered by the second submission are: bread; flour; whole wheat flour and other flours; French fries; potato chips and potato-based products; reaction flavours; and unstandardized cereal-based products such as cakes, biscuits, cookies and processed breakfast cereals. Asparaginase would be used to reduce levels of free asparagine in food, thereby reducing the risk of formation of acrylamide. Acrylamide is formed as a reaction product between asparagine and reducing sugars when certain foods are baked or fried at temperatures exceeding 120oC. Both asparagine and reducing sugars are commonly found in many raw food materials. Dietary exposure to acrylamide has been identified as of potential concern by the Joint FAO/WHO Expert Committee on Food Additives. Evaluation of the available data supports the safety and effectiveness of asparaginase as a food additive for the uses as proposed. Asparaginase is permitted for use in Australia, China, Denmark, Mexico, the Netherlands, New Zealand, Russia, Singapore, Switzerland and the United States, and has been given a favourable evaluation by the Joint FAO/WHO Expert Committee on Food Additives. Therefore, it is the intention of Health Canada to recommend that the Food and Drug Regulations be amended to permit the use of asparaginase as a food additive in bread, flour and whole wheat flour, and unstandardized foods, at a maximum level of use consistent with Good Manufacturing Practice, that is, the minimum amount needed for the intended technical effect.
Products Covered: Bread; flour and whole wheat flour; unstandardized foods
Regulation Type: Regular notification
Draft Amendment of the Official Standards for Ordinary Fertilizers (
Distribution date: 15 December 2009 | Final date for Comment: 13 February 2010
The draft amendment of Official Standards for Ordinary Fertilizers proposes new maximum levels of the following agricultural chemicals or other substances permissible to be contained in certain types of fertilizer. ; - 2-(4-chloro-6-ethylamino-1,3,5-triazin-2-ylamino)-2-methylpropionitrile and 2,6-dichlorobenzonitrile in complex fertilizer; ; - (RS)-N-[2-(3,5-dimethylphenoxy)-1-methylethyl]-6-(1-fluoro-1-methylethyl)-1,3,5-triazine-2,4-diamine and 2,6-dichlorobenzonitrile in complex fertilizer; ; - 3-allyloxy-1,2-benzisothiazole 1,1-dioxide in mixed fertilizer; and ; - 3-(2-chloro-1,3-thiazol-5-ylmethyl)-5-methyl-1,3,5-oxadiazinan-4-ylidene(nitro)amine and N-[2-(2,6-dimethylphenyl)amino]-2-oxoethyl]-N,N-diethylbenzemethanaminium benzoate in home garden-use mixed fertilizer. ;
Products Covered: Fertilizer (HS: 3105)
Regulation Type: Regular notification
Draft Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 050: "Ferrous scrap metal" (6 pages, in Spanish)
Distribution date: 14 December 2009 | Final date for Comment: 12 February 2010
Este Proyecto de Reglamento contiene el objeto, campo de aplicación, definiciones, condiciones generales, clasificación, requisitos, requisitos de rotulado, ensayos para evaluar la conformidad, muestreo, documentos normativos consultados o de referencia, demostración del cumplimiento, organismos encargados de la evaluación y la certificación de la conformidad, autoridad de fiscalización y/o supervisión, tipo de fiscalización y/o supervisión, régimen de sanciones, responsabilidad de los organismos de evaluación de la conformidad y, revisión y actualización, para chatarra metálica ferrosa.
Products Covered: 72043000, 72044100, 72045000
Regulation Type: Regular notification
TITLE: Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment ; ; AGENCY: Food and Drug Administration (FDA) ; ; ACTION: Final Rule; Technical Amendment ; ; SUMMARY: The Food and Drug Administration (FDA) is amending a final rule that appeared in the Federal Register of April 29, 2009 (74 FR 19385) (as amended in the Federal Register of June 30, 2009 (74 FR 31177). The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs). This document is intended to clarify some provisions in the final rule which may be unclear. Specifically, this document addresses how blister cards can be labeled to comply with the new required labeling, clarifies the length of time that the “See new warnings” flag is required to appear in the labeling, and provides some optional wording to clarify the liver injury warning on OTC acetaminophen products containing multiple active ingredients. ; ; Effective Date: This final rule is effective April 29, 2010. ; ; Compliance Date: The compliance date for all products subject to this final rule, including products with annual sales less than $25,000, is April 29, 2010. ; ; URL: http://edocket.access.gpo.gov/2009/E9-28296.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-28296.pdf ;
Distribution date: 11 December 2009
Products Covered: Over-the-counter human drugs, Internal analgesic, antipyretic, and anti-rheumatic drug products (HS: Chapter 3004; ICS: 11)
Regulation Type: Addendum to Regular Notification
Partial revision of the Japanese Pharmacopoeia Fifteenth edition (1 page, available in English)
Distribution date: 09 December 2009 | Final date for Comment: 20 January 2009
Under the provision of Article 41 of the Pharmaceutical Affairs Law, Ministry of Health and Labour and Welfare revises the Japanese Pharmacopoeia Fifteenth edition.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
The European Communities would like to inform the Members of the TBT Committee that Commission Regulation (EC) No 1020/2009 amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I, III, IV and V thereto to technical progress was adopted on 28 October 2009 and published in the Official Journal of the EU L 282 on 29 October 2009. ; ; The text of the regulation is available on the EC-TBT website in English, French and Spanish: http://ec.europa.eu/enterprise/tbt/, and at ; ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:282:0007:0014:EN:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:282:0007:0014:FR:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:282:0007:0014:ES:PDF ; ; and in all the official languages of the EU at ; ; http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2009:282:SOM:EN:HTML ; ; And can also be downloaded here: http://members.wto.org/crnattachments/2009/tbt/eec/09_4209_00_e.pdf
Distribution date: 08 December 2009
Products Covered: Fertilisers (HS: 31)
Regulation Type: Addendum to Regular Notification
Plant protection products; CN heading 3808 (fungicides, herbicides, anti-sprouting products and plant-growth regulators, among other similar products)
Distribution date: 07 December 2009
The proposal notified in G/SPS/N/EEC/289 (dated 2 August 2006) has been adopted as "Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC" [OJ L309, 24 November 2009, pp.1-50].
Products Covered:
Regulation Type: Addendum to 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
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
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
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