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List of banned and controlled substancesList of Banned and Controlled Substances
The list of substances subject to the regulation was prepared based on the JIG-101 Ed. 4.1 Table A-JIG Declarable Substance List (hereafter "Source List")A Classification column, reference numbers for Shimadzu use and Remarks column were added to the Source List. In addition, Note 8 was changed and Notes 11 through 16 and No.60 were addedContent levels that exceed the threshold levels must be reported, regardless of classification.
The Key Legal and Regulatory or Industry Standard/Agreement Citation column indicates new changes and other information related to regulations such as REACH. In general, substances listed in REACAppendix XIV are banned as of one year prior to the indicated sunset date.
Substances indicated in the Reportable Application(s) column are banned from being added intentionally. Content level must not exceed the threshold level, if indicated Content levels that exceed the threshold level must be reported. Content levels below the threshold level are treated as no content Note: If "Comply with RoHS" or "RoHS compliance" is indicated on Shimadzu drawings, specifications, or other relevant documents, it indicates that the content of substances banned under RoHS(indicated by "Banned under RoHS" in the "Remarks" column below) must not exceed the threshold level.
"Must not contain any banned substances per Shimadzu Green Procurement Standards" indicates that the content of banned substances must not exceed the threshold value.
Applications exempt from the RoHS Directive are indicated in the RoHS Directive Exemptions - Table 1 (MT83-6029) and RoHS Directive Exemptions - Table 2 (MT83-6030). Please see web page.
Indication of "another list" in the table below refers to the attached Detailed Substance List with CAS Numbers (MT83-6015). Please see web pageIndication of "report" in the table below refers to information reported in response to a content survey requested by Shimadzu. The Examples of Use column simply indicates examples. Substances subjeto chemical content surveys are indicated in the Reportable Application(s) column.
The Revision Type column indicates (i) new added substances, (ii) changes to substances reported, and (iii) changes to threshold levelsIn the Criteria column, R indicates substance is subject to law or regulation, A indicates substances used for assessment, and I indicates information for submission. ANNEX XVII of REACH Regulation (EC)No 1907/2006; US TSCA; Swiss (1 000 ppm) of the product adhesive,lubricant (1 000 ppm) of the product adhesive,lubricant 4-[4,4'-bis(dimethylamino)benzhydrylidene] cyclohexa-2,5- CAS# 548-62-9 dimethylammonium chloride(C.I. Basic Violet 3) In wood veneers/ pressed woodenpanels as starch additive, flame preservative,as flame retardant inwood, cotton and other plant derivedmaterial Cadmium/cadmium compounds See another list China MII Methods; Korea RoHS; Japan J- batteries Control of Industrial Products ActEU Battery Directive 2006/66/EC Cadmium/cadmium compounds See another list "Limitation of mercury,cadmium and lead contents for alkaline and non-alkaline zincmanganese dioxide batteries" (a) textile andleather articlesintended to comeinto contact withthe skin, (c) twocomponentroom temperaturevulcanisationmoulding kits(RTV-2 mouldingkits) Controlled Disodium tetraborate,anhydrous See another list extinguishing agents, cleaning agents, 4/28/2009 Austria - BGB I 1990/194:Formaldehydverordnung, §2, 12/2/1990; Rubber hardener, pigment, paint,lubricant, plastic stabilizer, China MII Methods; Korea RoHS; Japan J- noted below materials, curing agent, vulcanizingagent, ferroelectrics, plating, metalalloy Consumerproducts designed 0.01% by weight (100 Improvement Act as amended by HB 2715 primarily for Paint and similarsurface coatings of 0.009% by weight (90 EU Battery Directive 2006/66/EC; ChineseStandard GB 24427-2009 "Limitation of alkaline and non-alkaline zinc manganesedioxide batteries" Article 33 and 7.2 of REACH Regulation(EC) No 1907/2006 (Candidate list of Article 33 and 7.2 of REACH Regulation(EC) No 1907/2006 (Candidate list of Vermont act relating to comprehensivemanagement of exposure to mercury;Rhode Island General Laws 23-24.9 and Directive 2011/65/EU; China MII Methods;Korea RoHS; Japan J-MOSS; US/CA SB-20/50 Rhode Island & Connecticut MercuryReduction and Education Acts; New York Env Law § 27-0719 Battery Managementand Disposal; Taiwan Restrictions on theManufacture, Import, and Sale of Dry Cell industrial products Battery regulation; EU Battery Directive 2006/66/EC; ChineseStandard GB 24427-2009 "Limitation ofmercury, cadmium and lead contents foralkaline and non-alkaline zinc manganesedioxide batteries" US/ California - Perchlorate Contamination Commission Regulation (EU) No757/2010; Canadian Environmental Protection Act SOR/ 2008-178; Japan Law All plastics, inked ribbons, putty, caulking 4/28/2009 Insulation oil, lubricant oil, electrical electrolytic solution; plasticizers, flame Insulation oil, lubricant oil, electricalinsulation medium, solvent, electrolytic solution; plasticizers, flame 3/10/2011 retardants, coatings for electrical wireand cable, dielectric sealants waterresistant) insulator, flameretardant EU-D 96/29/Euratom; Japan Law for theRegulation of Nuclear Source Material, 1986; Japan Law Concerning Preventionfrom Radiation Hazards; US NRC Insulation in high-temp test equipment 3/31/2010 Insulation in high-temp test equipment 3/31/2010 Article 33 and 7.2 of REACH Regulation(EC) No 1907/2006 (Candidate list ofSVHC for authorization 28.10.2008), 06-01-922;Swiss Ordinance on Reduction of Riskfrom Chemical Products Controlled tetramethylbutyl)phenol, (4-tert- ANNEX XVII of REACH Regulation (EC)No 1907/2006 and Commission ppm) of tin in a material 6, 8 antiseptic, paint, pigment, antistaining chemical substancesNorwegian product regulation 1. The European Community's ban applies to azocolourants and azodyes that by reductive cleavage of azo groups may release one of the aromatic amines listed in another list. The threshold level given applies to these amines, not to the azocolourants and azodyes 2. Formerly known as EICTA3. Now part of TechAmerica4. A printed wiring board laminate refers to the layered board materials excluding surface finishing and components5. The battery reporting threshold level is based on the strictest known legal requirement. However, for simplification, the same reporting threshold level is set for all kind of batteries, even if the underlying legal requirement is only applicable for only one specific battery type.
6. Commission Regulation (EU) No 276/2010 defines a concentration limit of 0.1% by weight of tin in the article or part thereof. Likewise Commission Decision 2009/251/EC defines a concentration limit of 0.00001% by weight of DMF in the product or part of the product and Commission Regulation (EC) No 552/2009 defines a concentration limit of 0.1% by weight of PFOS in the semifinished product orarticle or part thereof. Because no legal definition of part is provided in these legislations, the most potentially restrictive concentration limit is not adequately specified. Therefore, the concentration limit isapplied at the level of a material vs. a part to ensure disclosure of the regulated substances for the most basic unit of a part 7. Regulatory thresholds for substances in these applications are based on emission or exposure limits rather than on the concentration in the product. Examples of regulatory limits are: Formaldehyde in hardwood plyboard with veneer core - 0.05 ppm (measured as gaseous emission from product); For Nickel in applications of prolonged skin contact - 0.5 micrograms/sq cm/week per DIN EN 1811;Radioactive substances -a dose rate exceeding 1 μSv h–1 at a distance of 0,1 m.
Because emission and exposure levels cannot be derived from actual concentrations, a threshold level of "intentionally added" is indicated for reporting. Suppliers may choose to report a defaultconcentration of 0.1% by weight in the product for these substances, in lieu of determining the exact concentrations in their products, to indicate that the substance is known to be present in their product,as the actual concentration in the product is not informative for regulatory compliance assessment.
8. See Annex C of Jig-101 Ed.4.1 for clarification of how the two reporting thresholds apply.
9. Nickel must be reported in certain regulated applications where it is likely to result in prolonged skin exposure (e.g., an outer enclosure for a portable electronic product designed to be carried). Use of nickel or nickel contained in components and parts designed to be located inside the outer enclosure of a product need not be reported.
10. The threshold level here is the sum of the phthalate concentrations of the phthalates (identified in the respective another list tables) in the selected phthalate group designated by the Substance/Categor11. Due to use in special applications, do not ban or report substance if specified accordingly on drawings or other documentation. Content is banned if not specified otherwise on the drawings or other documentation12. REACH Appendix XVII lists applications where indicated substances can be used for a limited period. For such applications, Shimadzu permits usage up to one year prior to the indicated time limit.
Example: Use of dibutyltin compounds (DBT) in RTV sealants 13. Specific REACH SVHCs containing lead and chromium are not individually listed in above Table since the EU Packaging directive limit of 0.01% (100 ppm) total metals was determined to be the 14. See Annex C of Jig-201 Ed.1.1 for clarification of how the two reporting thresholds apply15. US State Toxics in Packaging Clearinghouse web site clarifies that ink is considered a separate “packaging component” so the threshold limit for reporting was set at material vs. packaging item.
16. The EU Directive 94/62EC, U.S. Model Toxics in Packaging Legislation (TIP), and other regulations require that packaging must not contain more than 0.01 % by weight (100 ppm) of lead, mercury cadmium, or their compounds, or hexavalent chromium (so called "Packaging Directives").
No. 60 will be used if packaging or packaging material is compliant with "Packaging Directives".
June 23, 2011 Supreme Court Rules That Generics Are Not Liable For Insufficient Warnings in Product Labeling In a long-awaited decision, the United States Supreme Court ruled today in Pliva v. Mensing (Case No. 09-993), that generic drug manufacturers cannot be held liable for insufficient warnings in the labels of their generic products. The case involved the drug metocloprami