Regulatory Updates
Sanitary import requirements for bovine blood, plasma, serum and products.
Distribution date: 03 July 2013 | Final date for Comment: 01 September 2013
Draft regulation that establishes the sanitary import requirements for bovine blood, plasma, serum and products (except blood meal).
Products Covered: Blood, plasma, serum and products - HS Code: 300210.
Regulation Type: Revision to Regular Notification
Sanitary import requirements for bovine blood, plasma, serum and products.
Distribution date: 03 July 2013 | Final date for Comment: 01 September 2013
Draft regulation that establishes the sanitary import requirements for bovine blood, plasma, serum and products (except blood meal).
Products Covered: Blood, plasma, serum and products - HS Code: 300210.
Regulation Type: Revision to Regular Notification
<pre><p>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; confirmation of effective date</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of 2 May 2013, for the final rule that published in the Federal Register of 1 April 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.</p><p>DATES: Effective date confirmed: 2 May 2013.</p></pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/html/2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/pdf/2013-15111.pdf
Distribution date: 03 July 2013
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
<pre><p>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Final rule; confirmation of effective date</p><p>SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of 2 May 2013, for the final rule that published in the Federal Register of 1 April 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.</p><p>DATES: Effective date confirmed: 2 May 2013.</p></pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/html/2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/pdf/2013-15111.pdf
Distribution date: 03 July 2013
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
<p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS)</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>ACTION: Final rule; confirmation of effective date</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of 2 May 2013, for the final rule that published in the Federal Register of 1 April 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>DATES: Effective date confirmed: 2 May 2013.</span></span></span></p> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/html/2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/pdf/2013-15111.pdf
Distribution date: 03 July 2013
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
<p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>AGENCY: Food and Drug Administration (FDA), Health and Human Services (HHS)</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>ACTION: Final rule; confirmation of effective date</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>SUMMARY: The Food and Drug Administration (FDA or we) is confirming the effective date of 2 May 2013, for the final rule that published in the Federal Register of 1 April 2013 (78 FR 19413), and that amended the color additive regulations to provide for the safe use of additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246) and copolymers of 1,4-bis[(2- hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) as color additives in contact lenses.</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>DATES: Effective date confirmed: 2 May 2013.</span></span></span></p> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/html/2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-06-25/pdf/2013-15111.pdf
Distribution date: 03 July 2013
Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)
Regulation Type: Addendum to Regular Notification
Reclassification of Specially Denatured Spirits and Completely Denatured Alcohol Formulas and Related Amendments (18 pages in English).
Distribution date: 03 July 2013 | Final date for Comment: 26 August 2013
<pre>The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend its regulations concerning denatured alcohol and products made with industrial alcohol. The proposed amendments would 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 proposed amendments would remove unnecessary regulatory burdens on the industrial alcohol industry as well as TTB, and would align the regulations with current industry practice. The proposed amendments would also make other needed improvements and clarifications, as well as a number of minor technical changes and corrections to the regulations. TTB invites comments on these proposed amendments to the regulations.</pre>
Products Covered: Specially denatured spirits and completely denatured alcohol formulas
Regulation Type: Regular notification
Reclassification of Specially Denatured Spirits and Completely Denatured Alcohol Formulas and Related Amendments (18 pages in English).
Distribution date: 03 July 2013 | Final date for Comment: 26 August 2013
<pre>The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend its regulations concerning denatured alcohol and products made with industrial alcohol. The proposed amendments would 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 proposed amendments would remove unnecessary regulatory burdens on the industrial alcohol industry as well as TTB, and would align the regulations with current industry practice. The proposed amendments would also make other needed improvements and clarifications, as well as a number of minor technical changes and corrections to the regulations. TTB invites comments on these proposed amendments to the regulations.</pre>
Products Covered: Specially denatured spirits and completely denatured alcohol formulas
Regulation Type: Regular notification
Sanitary import requirements for gelatin of bovines.
Distribution date: 02 July 2013 | Final date for Comment: 31 August 2013
Draft regulation that establishes the sanitary import requirements for gelatin of bovines.
Products Covered: Gelatin of bovines- HS Code: 350300.
Regulation Type: Regular notification
Sanitary import requirements for gelatin of bovines.
Distribution date: 02 July 2013 | Final date for Comment: 31 August 2013
Draft regulation that establishes the sanitary import requirements for gelatin of bovines.
Products Covered: Gelatin of bovines- HS Code: 350300.
Regulation Type: Regular notification
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