Regulatory Updates
Partial amendment to the Minimum Requirements for Radiopharmaceuticals (1 page, in English)
Distribution date: 22 September 2016 | Final date for Comment: 20 October 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The Minimum Requirements for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Radiopharmaceuticals </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">are to</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">be partially amended to add the standard</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">for </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">a radiopharmaceutical </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">to be newly approved.</span></span></span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
DUS 1575:2016, Occupational safety - Onshore oil and gas production operations - Requirements (38 pages, in English)
Distribution date: 22 September 2016 | Final date for Comment: 21 November 2016
<p><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">This Draft Uganda standard </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">covers occupational safety practices that apply to production operations, drilling, well servicing and work over operations to ensure occupational safety of personnel within the oil and gas sector and or industry. </span></span></span><span style="line-height:107%;font-family:'Calibri','sans-serif';font-size:11pt;">The requirements in this Draft Uganda Standards are intended to ensure that the oil and gas industry implements occupational safety practices concentrating on personal protection and safe workplace, to include: owners, operators, contractors, and service providers during oil and gas operations and production.</span></p>
Products Covered: Occupational safety, onshore oil and gas production operations
Regulation Type: Regular notification
Textiles - High Density Polyethylene and Polypropylene Woven Sacks for Packaging or Filling (Quality Control) Order, 2016 (4 pages, in English)
Distribution date: 22 September 2016 | Final date for Comment: 21 November 2016
<p>This Order seeks to ensure conformity to High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for Packaging / Filling listed in the Schedule to the specified Indian Standards.</p>
Products Covered: IS 14887: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging of 50 kg Foodgrains (HS Code 39232100/39232990) ; ; IS 16208: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging 10 kg, 15 kg, 20 kg, 25 kg and 30 kg Foodgrains (HS Code 39232100/39232990) ; ; IS 14968: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for packaging 50 kg / 25 kg Sugar (HS Code 39232100/39232990) ; ; IS 14252: Textiles - High Density Polyethylene (HDPE) / Polypropylene (PP) Woven Sacks for filling Sand (HS Code 39232100/39232990)
Regulation Type: Regular notification
Proposed Amendments to the Regulation on the Safety and Efficacy Evaluation for Veterinary Pharmaceutical Products
Distribution date: 20 September 2016 | Final date for Comment: 19 November 2016
The proposed amendments mainly focus on the following: Adding the list of veterinary pharmaceutical products to exempt the data on residue from the required documents, etc.
Products Covered: Veterinary pharmaceutical products
Regulation Type: Regular notification
DUS 310-1:2016, Cement — Part 1: Composition, specification and conformity criteria for common cements. (32 pages, in English).
Distribution date: 19 September 2016 | Final date for Comment: 07 November 2016
<p><span lang="EN-GB" style="font-size:9.0pt;font-family:'Verdana','sans-serif';"></span><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;font-family:'Verdana','sans-serif';">This Draft Uganda standard gives the specifications which include mechanical, physical and chemical requirements of 27 distinct common cements, seven sulphate resisting common cements as well as three distinct low early strength blast furnace cements and two sulphate resisting low early strength blast cements and their constituents. The standard also gives the composition of each cement in terms of proportions and requirements of the constituents which are to be combined to produce these distinct products in a range of nine strength classes. Furthermore, this standard states the conformity criteria and the related rules. Necessary durability requirements are also given.</span></span></p><p style="margin-top:6.0pt;margin-right:0in;margin-bottom:6.0pt;margin-left:0in;text-align:justify;"><span style="color:black;font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;font-family:'Verdana','sans-serif';">In addition to the specified requirements, an exchange of additional information between the cement manufacturer and user may be helpful. The procedures for such an exchange are not within the scope of this standard but should be dealt with in accordance with national standards or regulations or may be agreed between the parties concerned. </span></span><span style="font-family:Verdana, sans-serif;font-size:9pt;line-height:1.5;">The word "cement" in this standard is used to refer only to common cements unless otherwise specified.</span></p>
Products Covered: Cement, Portland cement, Portland–slag cement, Portland silica fume cement, Portland–Pozzolana cement, Portland –fly ash cement, Portland–burnt shale cement, Portland–limestone cement, Portland composite cement, Blast–furnace cement, Pozzolanic cement, Composite cement.
Regulation Type: Regular notification
McCormick & Company, Inc.; Filing of Color Additive Petition; Notice of Petition
Distribution date: 19 September 2016
The Food and Drug Administration has filed a petition, submitted by McCormick & Company, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract to color shell eggs at levels consistent with good manufacturing practice.
Products Covered: HS Codes: 29, 04; ICS Codes: 67
Regulation Type: Regular notification
DUS EAS 491:2006, Incineration plant for the destruction of hospital waste - Specification. (12 pages, in English).
Distribution date: 16 September 2016 | Final date for Comment: 07 November 2016
<p><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">This Draft Uganda Standard </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">specifies </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">destruction of hospital waste. Devices which utilize intensities of combustion exceeding an average heat release rate of 350 W/m<sup>3</sup> are not included. This standard does not specify materials or methods of construction.</span></span></span></span><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:10pt;"></span></p>
Products Covered: Incineration plant, hospital waste.
Regulation Type: Regular notification
National technical regulations on quality of inorganic fertilizers: ; 1. Amoni polyphosphate fertilizers (8 pages, in Vietnamese) ; 2. Ammonium chloride fertilizers (7 pages, in Vietnamese) ; 3. Ammonium sulphate fertilizers (8 pages, in Vietnamese) ; 4. Calcium nitrate fertilizers (8 pages, in Vietnamese) ; 5. Diammonium phosphate fertilizers (8 pages, in Vietnamese) ; 6. Potassium chloride fertilizers (7 pages, in Vietnamese) ; 7. Potassium nitrate fertilizers (8 pages, in Vietnamese) ; 8. Potassium sulphate fertilizers (8 pages, in Vietnamese) ; 9. Calcium magnesium phosphate fertilizers (8 pages, in Vietnamese) ; 10. Potassium magnesium sulphate fertilizers (8 pages, in Vietnamese) ; 11. Monoamoni phosphate fertilizers (8 pages, in Vietnamese) ; 12. Monokali phosphate fertilizers (8 pages, in Vietnamese) ; 13. Sodium nitrate fertilizers (8 pages, in Vietnamese) ; 14. Nitro phosphate fertilizers (8 pages, in Vietnamese) ; 15. Single super phosphate fertilizers (8 pages, in Vietnamese) ; 16. Super rich phosphate fertilizers (8 pages, in Vietnamese) ; 17. Double super phosphate fertilizers (9 pages, in Vietnamese) ; 18. Urea fertilizers (8 pages, in Vietnamese)
Distribution date: 15 September 2016 | Final date for Comment: 14 November 2016
<p style="margin:6pt 0in;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">These draft <span style="letter-spacing:-0.1pt;">technical regulations</span> specify the technical requirements, test methods</span></span><span lang="EN-GB" style="letter-spacing:-0.1pt;"> and other </span><span lang="EN-GB">requirements for inorganic</span><span lang="EN-GB"> </span><span lang="EN">fertilizers.</span></p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana',sans-serif;font-size:9pt;">These technical regulations applies to all organizations and individuals involved in activities relating to inorganic fertilizer in Vietnam, except otherwise regulated differently by international treaties of which Viet Nam is a member or party.</span></span>
Products Covered: FERTILIZERS (HS code(s): 31); Fertilizers (ICS code(s): 65.080)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Sweeteners to Enable the Use of Steviol Glycosides as a Sweetener in Nutritional Supplement Bars - Document Reference Number: NOM/ADM-0078
Distribution date: 13 September 2016 | Final date for Comment: 05 November 2016
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of steviol glycosides as a sweetener in nutritional supplement bars. Currently, steviol glycosides are permitted for use as sweeteners in various foods in Canada, including meal replacement bars. As no safety concerns were raised through Health Canada's assessment the Department has enabled the food additive use of steviol glycosides as a sweetener described in the information document below by updating the List of Permitted Sweeteners (http://hc-sc.gc.ca/fn-an/securit/addit/list/9-sweetener-edulcorant-eng.php), effective 23 August 2016. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.
Products Covered: Steviol glycosides (ICS Codes: 67.220, 67.230)
Regulation Type: Regular notification
<pre><p>TITLE: Reclassification of Specially Denatured Spirits and Completely Denatured Alcohol Formulas and Related Amendments</p><p>AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury</p><p>ACTION: Final rule; Treasury decision</p><p>SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is amending its regulations concerning denatured alcohol and products made with industrial alcohol. The amendments eliminate outdated specially denatured spirits formulas from the regulations, reclassify some specially denatured spirits formulas as completely denatured alcohol formulas, and issue some new general-use formulas for manufacturing products with specially denatured spirits. The amendments remove unnecessary regulatory burdens on the industrial alcohol industry, as well as on TTB, and align the regulations with current industry practice. The amendments also make other improvements and clarifications, as well as a number of minor technical changes and corrections to the regulations.</p><p>This final rule is effective 31 October 2016. </p></pre>
Distribution date: 05 September 2016
Products Covered: Specially denatured spirits and completely denatured alcohol formulas
Regulation Type: Addendum to Regular Notification
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