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
TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Extension of Comment Period ; ; AGENCY: Food and Drug Administration ; ; ACTION: Proposed Rule; extension of comment period ; ; SUMMARY: The Food and Drug Administration (FDA) is extending to 5 February 2010, the comment period for the proposed rule that appeared in the Federal Register of 23 September 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. ; ; DATES: Submit electronic or written comments by 5 February 2010. ; ; URL: ; http://edocket.access.gpo.gov/2009/E9-26966.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-26966.pdf ;
Distribution date: 19 November 2009
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
Draft Regulation Regarding the Production, Import, Marketing and Inspection Of Organic, Organomineral Fertilizers And Soil Amendment Products And Other Products, Microbial And Enzyme Based Products (37 Pages in Turkish and English)
Distribution date: 10 November 2009 | Final date for Comment: 09 January 2010
The Regulation covers the promotion, definition, maintaining of analysis methods, production, import, marketing and inspection of Organic, Organomineral Fertilizers, Soil Amendment Products and Other Products, Microbial and Enzyme Based Products in order to protect consumers, to improve soil fertility and quality, to protect human health and environment. The Regulation defines the norms, content and features of the products.
Products Covered: Organic, Organomineral Fertilizers, Soil Amendment Products, Microbial and Enzyme Based Products and Other Products (HS : 3101)
Regulation Type: Regular notification
TITLE: Hazard Communication; Correction ; ; AGENCY: Occupational Safety and Health Administration (OSHA), Department of Labor ; ; ACTION: Proposed rule: correction ; ; SUMMARY: This document corrects the OSHA Hazard Communication standard ; proposed rule and request for comment, published in the Federal Register of September 30, 2009. This notice corrects eight errors, four in the preamble and four that appear in Appendix A: Table A.1.1, Table A.1.2, Table A.2.3, and Table A7.1. ; ; Full text: ; http://edocket.access.gpo.gov/2009/E9-26579.htm ; http://edocket.access.gpo.gov/2009/pdf/E9-26579.pdf ; ;
Distribution date: 10 November 2009
Products Covered: Chemicals (HS: Chapter 29 ) (ICS: 13, 71)
Regulation Type: Corrigendum to Regular Notification
Proposed Significant New Use Rules on Certain Chemical Substances (7 pages, English)
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
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