Regulatory Updates

Guidance for New chemical substance declaration and registration (Draft) (131 pages, in Chinese)

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Distribution date: 08 March 2016 | Final date for Comment: 07 May 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana',sans-serif;font-size:9pt;">The guidance is a technical document that guides the declarant to complete new chemical substance declaration and registration. The guidance specifies the applicable scope, declaration type and procedure, dossier requirements, and post-registration supervision and management of new chemical substance.</span></span>

Products Covered: New chemical substances that are researched, produced, imported, or used within the territory of the People's Republic of China

Regulation Type: Regular notification

Guidance for New chemical substance declaration and registration (Draft) (131 pages, in Chinese)

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Distribution date: 08 March 2016 | Final date for Comment: 07 May 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana',sans-serif;font-size:9pt;">The guidance is a technical document that guides the declarant to complete new chemical substance declaration and registration. The guidance specifies the applicable scope, declaration type and procedure, dossier requirements, and post-registration supervision and management of new chemical substance.</span></span>

Products Covered: New chemical substances that are researched, produced, imported, or used within the territory of the People's Republic of China

Regulation Type: Regular notification

KS 1942: 2016 Bathing Bars - Specification (15 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 08 April 2016

<p style="text-align:justify;tab-stops:-1.0in -.5in;">Prescribes the requirements and methods of test for bathing bars.&nbsp; This standard applies to bathing bars supplied in the form of cakes and produced from vegetable or animal oils or fats, fatty acids, or from a blend of all or part of these materials, with or without the addition of rosins or non-soapy surfactants.</p>

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Essential oils (ICS code(s): 71.100.60); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Human health

KS 1942: 2016 Bathing Bars - Specification (15 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 08 April 2016

<p style="text-align:justify;tab-stops:-1.0in -.5in;">Prescribes the requirements and methods of test for bathing bars.&nbsp; This standard applies to bathing bars supplied in the form of cakes and produced from vegetable or animal oils or fats, fatty acids, or from a blend of all or part of these materials, with or without the addition of rosins or non-soapy surfactants.</p>

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Essential oils (ICS code(s): 71.100.60); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Human health

KS 2356:2015, Bio-Fertilizer - Specification (74 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 05 April 2016

<p style="margin-right:.1in;text-align:justify;text-autospace:none;"><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">This Kenya Standard specifies requirements for bio-fertilizers. It does not cover<span>&nbsp;&nbsp; </span><span>&nbsp;</span>manures and plant growth promoters.</span><span lang="EN-GB" style="font-family:'Bookman Old Style','serif';"> </span><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">Bio-fertilizer</span><strong> </strong><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">are products containing living organisms which colonize the rhizosphere or the interior of the plant and promote growth by increasing the supply or availability of primary nutrients and/or growth stimulus to the target crop, when applied to seed, plant surfaces, or soil. They may be formulated in different types of inorganic and organic carriers.</span></p>

Products Covered: FERTILIZERS (HS code(s): 31); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

KS 2356:2015, Bio-Fertilizer - Specification (74 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 05 April 2016

<p style="margin-right:.1in;text-align:justify;text-autospace:none;"><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">This Kenya Standard specifies requirements for bio-fertilizers. It does not cover<span>&nbsp;&nbsp; </span><span>&nbsp;</span>manures and plant growth promoters.</span><span lang="EN-GB" style="font-family:'Bookman Old Style','serif';"> </span><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">Bio-fertilizer</span><strong> </strong><span lang="EN-GB" style="font-size:12.0pt;font-family:'Bookman Old Style','serif';">are products containing living organisms which colonize the rhizosphere or the interior of the plant and promote growth by increasing the supply or availability of primary nutrients and/or growth stimulus to the target crop, when applied to seed, plant surfaces, or soil. They may be formulated in different types of inorganic and organic carriers.</span></p>

Products Covered: FERTILIZERS (HS code(s): 31); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

KS 2231:2016 Antibacterial Bathing Bars - Specification (24 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 08 April 2016

<p>Prescribes the requirements and methods of test for antibacterial bathing bars.&nbsp;It applies to antibacterial bathing bars supplied in the form of cakes and produced from vegetable or animal oils or fats, fatty acids, or from a blend of all or part of these materials, with or without the addition of rosins or non-soapy surfactants. <span lang="EN-GB" style="font-family:'Arial','sans-serif';font-size:10pt;"></span></p>

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Essential oils (ICS code(s): 71.100.60); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Human health

KS 2231:2016 Antibacterial Bathing Bars - Specification (24 pages, in English)

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Distribution date: 07 March 2016 | Final date for Comment: 08 April 2016

<p>Prescribes the requirements and methods of test for antibacterial bathing bars.&nbsp;It applies to antibacterial bathing bars supplied in the form of cakes and produced from vegetable or animal oils or fats, fatty acids, or from a blend of all or part of these materials, with or without the addition of rosins or non-soapy surfactants. <span lang="EN-GB" style="font-family:'Arial','sans-serif';font-size:10pt;"></span></p>

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33); Essential oils (ICS code(s): 71.100.60); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Human health

<p align="left"><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Notice of Intent to Amend the Prescription Drug List (PDL): Fluticasone propionate</span></span></span><span lang="EN-GB"> </span></p><p align="left"><span lang="EN-GB">The proposed amendment notified in G/TBT/N/CAN/472 (dated 3 December 2015) was adopted 26 February 2016. </span></p><p align="left"><span lang="EN-GB"></span><span lang="EN-GB">The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to exempt certain uses of Fluticasone propionate. Health Canada has conducted a scientific review of Fluticasone propionate against the set of established and publicly available criteria </span><span lang="EN-GB">outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the 27 November 2015 Notice of Consultation. </span><span lang="EN-GB">This revision will be in effect six months from the date of this Notice posted on the Health Canada website. </span></p><p align="left"><span lang="EN-GB">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-eng.php</a></span><span lang="EN-GB">&nbsp; (English) </span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-fra.php</a>&nbsp; (French)</span></span></p><p style="line-height:13.5pt;margin-bottom:12pt;"><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:Verdana, sans-serif;font-size:9pt;">or requested from:</span></span></p><p align="left">Canada's SPS &amp; TBT Notification Authority and Enquiry Point<br />Global Affairs Canada Technical Barriers and Regulations Division (TPB) <br />111 Sussex Drive, Ottawa, ON K1A 0G2 Canada <br />Telephone: (343)203-4273 <br />Fax: (613)943-0346 <br />E-mail: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a>&nbsp;<br /></p>

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Distribution date: 04 March 2016

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Addendum to Regular Notification

<p align="left"><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Notice of Intent to Amend the Prescription Drug List (PDL): Fluticasone propionate</span></span></span><span lang="EN-GB"> </span></p><p align="left"><span lang="EN-GB">The proposed amendment notified in G/TBT/N/CAN/472 (dated 3 December 2015) was adopted 26 February 2016. </span></p><p align="left"><span lang="EN-GB"></span><span lang="EN-GB">The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will revise the listing for Adrenocortical hormones on the Prescription Drug List (PDL) to exempt certain uses of Fluticasone propionate. Health Canada has conducted a scientific review of Fluticasone propionate against the set of established and publicly available criteria </span><span lang="EN-GB">outlined in section C.01.040.3 of the <em>Food and Drug Regulations</em>. The wording remains unchanged from what was proposed in the 27 November 2015 Notice of Consultation. </span><span lang="EN-GB">This revision will be in effect six months from the date of this Notice posted on the Health Canada website. </span></p><p align="left"><span lang="EN-GB">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-eng.php</a></span><span lang="EN-GB">&nbsp; (English) </span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB"><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-fluticasone-propionate-fra.php</a>&nbsp; (French)</span></span></p><p style="line-height:13.5pt;margin-bottom:12pt;"><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:Verdana, sans-serif;font-size:9pt;">or requested from:</span></span></p><p align="left">Canada's SPS &amp; TBT Notification Authority and Enquiry Point<br />Global Affairs Canada Technical Barriers and Regulations Division (TPB) <br />111 Sussex Drive, Ottawa, ON K1A 0G2 Canada <br />Telephone: (343)203-4273 <br />Fax: (613)943-0346 <br />E-mail: <a href="mailto:enquirypoint@international.gc.ca">enquirypoint@international.gc.ca</a>&nbsp;<br /></p>

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Distribution date: 04 March 2016

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)

Regulation Type: Addendum to Regular Notification

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