Plant protection products; CN heading 3808 (fungicides, herbicides, anti-sprouting products and plant-growth regulators, among other similar products)
Distribution date: 07 December 2009 | Final date for Comment: 26 April 2025
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
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 | Final date for Comment: 26 April 2025
Products Covered: Fertilisers (HS: 31)
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
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 | Final date for Comment: 26 April 2025
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
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
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
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
Protective gloves against chemicals and micro-organisms: Terminology and performance requirements
Distribution date: 18 December 2009 | Final date for Comment: 16 February 2010
Revision of the Mandatory Standards SI 749 and SI 1284 part 4, to be replaced by SI 1284 part 4. This draft standard revision adopts both the European Standard EN 374-1: September 2003 as well as the American Standard ANSI/ISEA 105: November 2005 (except for paragraphs 5.1, 5.4 and 5.5) and allows for compliance with any of them. This revision includes changes in the normative references that appear in the Hebrew section and new requirements that product information should be provided in Hebrew and should include a reference to this standard number and name.
Products Covered: Protective gloves (ICS: 13.340.40; HS: 4015.11, 3926.20 and 4203.29).
Regulation Type: Regular notification
Withdrawal of the Order of the State Committee of Veterinary Medicine of Ukraine as of 12 March 2001 N° 23 "On Urgent Measures on Prevention and Elimination of the Appearance of the Bovine Spongiform Encephalopathy and Other Prion Infection"
Distribution date: 07 January 2010 | Final date for Comment: 26 April 2025
Draft Order of the State Committee of Veterinary Medicine of Ukraine dated 11 December 2009 N° 518 "On Recognition of Termination of the Order of the Chief Inspector of Veterinary Medicine of Ukraine as of 12 March 2001 N° 23" (the draft is approved by the State Committee of Veterinary Medicine and pending registration at the Ministry of Justice) causes also losing validity of requirements of the Order as of 20 May 2009 N° 149 "On Amendments to the Order of the Chief Inspector of Veterinary Medicine of Ukraine as of 12 March 2001 N° 23 "On Urgent Measures on Prevention and Elimination of the Appearance of the Bovine Spongiform Encephalopathy and Other Prion Infection"" concerning inspections of facilities, industrial processes, storage conditions and other requirements in the countries from which products are imported. This Order will enter into force after its registration by the Ministry of Justice and official publication. The expected date of entering into force is 1 January 2010. Thus since 1 January 2010 freight through the state border of Ukraine of the products concerned will be carried out in accordance with requirements of: Decree of the President of Ukraine N° 192 as of 22 March 2001 "On Urgent Measures to Ensure Stable Epizootic Situation in Ukraine"; Law of Ukraine "On Veterinary Medicine" N° 2498-XII as of 25 June 1992; Law of Ukraine "On Quality and Safety of Food Products" N° 771/97-VR as of 23 December 1997; Order of the Chief Inspector of Veterinary Medicine as of 27 December 1999 N° 49 "On Approval of the Order of freight of the goods across the state border of Ukraine controlled by the State Committee of Veterinary Medicine of Ukraine" (registered by the Ministry of Justice, 10 January 2000 N° 9/4230); and Order of the State Department of Veterinary Medicine as of 14 July 2004 N° 71 "On Approval of the Veterinary requirements for import into Ukraine of the objects under veterinary-sanitary control and supervision" (registered by the Ministry of Justice, 23 June 2004 N° 768/9367).
Products Covered:
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Extruders and Extrusion Lines for Rubber and Plastics - Part 2 :Safety Requirements for Die Face Pelletizers (15 pages, in Chinese).
Distribution date: 08 January 2010 | Final date for Comment: 09 March 2010
Chapters 5, 6 and 7 (except 7.2h）) are mandatory, the rest ones are voluntary. This standard specifies the essential safety requirements for die face pelletizers. It involves the terms and definitions, hazards and hazard areas, safety requirements and/or measures, verification of safety requirements and measures, information for use. This part is suitable for die face pelletizers for processing rubber and plastics.
Products Covered: Die face pelletizers for processing rubber and plastics (ICS: 71.120; 83.200, HS: 8477) ;
Regulation Type: Regular notification
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