Use of Materials Derived From Cattle in Human Food and Cosmetics; Final rule; adoption of interim final rule as final with amendments
Distribution date: 21 March 2016 | Final date for Comment: 04 May 2025
The US Food and Drug Administration (FDA) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. FDA has designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). It is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. The text is available at Federal Register 81 FR 14718, 18 March 2016 and https://www.gpo.gov/fdsys/pkg/FR-2016-03-18/pdf/2016-06123.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
<pre><p>TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; adoption of interim final rule as final with amendments</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. </p><p>DATES: This final rule is effective on 18 April 2016.</p></pre>
Distribution date: 23 March 2016 | Final date for Comment: 04 May 2025
Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)
Regulation Type: Addendum to Regular Notification
<pre><p>TITLE: Use of Materials Derived From Cattle in Human Food and Cosmetics</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; adoption of interim final rule as final with amendments</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. </p><p>DATES: This final rule is effective on 18 April 2016.</p></pre>
Distribution date: 23 March 2016 | Final date for Comment: 04 May 2025
Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)
Regulation Type: Addendum to Regular Notification
SI 5438 part 2 - Chemicals used for treatment of water intended for human consumption: Chlorine (23 pages, in English; 7 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 2, dealing with chlorine as a c</span></span></span>hemical used for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 739: June 2009<span>. </span>The major differences between the old version and this new revised draft standard are as follow:</span></span></p><ul><li>Removes the requirement for mercury (Hg)</li><li><span lang="EN-GB"><span style="letter-spacing:-0.1pt;">Remark A of Table 1 does not apply</span></span></li></ul>
Products Covered: Chemicals for purification of water - Chlorine
Regulation Type: Regular notification
SI 5438 part 2 - Chemicals used for treatment of water intended for human consumption: Chlorine (23 pages, in English; 7 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 2, dealing with chlorine as a c</span></span></span>hemical used for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 739: June 2009<span>. </span>The major differences between the old version and this new revised draft standard are as follow:</span></span></p><ul><li>Removes the requirement for mercury (Hg)</li><li><span lang="EN-GB"><span style="letter-spacing:-0.1pt;">Remark A of Table 1 does not apply</span></span></li></ul>
Products Covered: Chemicals for purification of water - Chlorine
Regulation Type: Regular notification
SI 5438 part 3 - Chemicals used for treatment of water intended for human consumption: Sodium hypochlorite (7 pages, in Hebrew; 39 pages, in English)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 3, dealing with s</span></span></span>odium hypochlorite used as a <span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 901: May 2013 and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory standards SI 2302 parts 1 and 2 </span></span>instead of the European legislation<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">.</span></span></p>
Products Covered: Chemicals for purification of water - Sodium hypochlorite
Regulation Type: Regular notification
SI 5438 part 3 - Chemicals used for treatment of water intended for human consumption: Sodium hypochlorite (7 pages, in Hebrew; 39 pages, in English)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 3, dealing with s</span></span></span>odium hypochlorite used as a <span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 901: May 2013 and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory standards SI 2302 parts 1 and 2 </span></span>instead of the European legislation<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">.</span></span></p>
Products Covered: Chemicals for purification of water - Sodium hypochlorite
Regulation Type: Regular notification
SI 5438 part 4 - Chemicals used for treatment of water intended for human consumption: Fluorosilicic acid (Hexafluorosilicic acid) (22 pages, in English; 8 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 4, dealing with f</span></span></span>luorosilicic acid (Hexafluorosilicic acid) used as a<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span> c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 12175: May 2013 </span></span><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;mso-fareast-language:EN-GB;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ansi-language:EN-GB;mso-bidi-language:AR-SA;">and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 instead of the European legislation.</span></span><span lang="EN-GB"><span style="letter-spacing:-0.1pt;"> </span></span></p>
Products Covered: Chemicals for purification of water - Fluorosilicic acid (Hexafluorosilicic acid)
Regulation Type: Regular notification
SI 5438 part 4 - Chemicals used for treatment of water intended for human consumption: Fluorosilicic acid (Hexafluorosilicic acid) (22 pages, in English; 8 pages, in Hebrew)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 5438 part 4, dealing with f</span></span></span>luorosilicic acid (Hexafluorosilicic acid) used as a<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span> c</span></span></span>hemical for purification of water<span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. This draft standard revision adopts the European Standard EN 12175: May 2013 </span></span><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;mso-fareast-language:EN-GB;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ansi-language:EN-GB;mso-bidi-language:AR-SA;">and changes the packaging, labelling, marking, storing and transporting requirements to comply with Israel Mandatory Standards SI 2302 parts 1 and 2 instead of the European legislation.</span></span><span lang="EN-GB"><span style="letter-spacing:-0.1pt;"> </span></span></p>
Products Covered: Chemicals for purification of water - Fluorosilicic acid (Hexafluorosilicic acid)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 30 March 2016 | Final date for Comment: 29 May 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Acetochlor.
Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.03, 07.08, 07.09 and 07.10) - Cereals (HS Codes: 10.01, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Code: 12.01)
Regulation Type: Regular notification
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