Specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption
Distribution date: 26 April 2016 | Final date for Comment: 02 May 2025
The proposal notified in G/SPS/N/EU/140 (7 July 2015) is now adopted as Commission Regulation (EU) 2016/355 of 11 March 2016 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption (Text with EEA relevance) [OJ L 67, 12 March 2016, pp. 22-28]. The Regulation applies from 21 January 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption
Distribution date: 26 April 2016 | Final date for Comment: 02 May 2025
The proposal notified in G/SPS/N/EU/140 (7 July 2015) is now adopted as Commission Regulation (EU) 2016/355 of 11 March 2016 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption (Text with EEA relevance) [OJ L 67, 12 March 2016, pp. 22-28]. The Regulation applies from 21 January 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_1655_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Import inspection requirement for commodities classified under 18 specific CCC codes if they are used for food or food additives
Distribution date: 26 April 2016 | Final date for Comment: 25 June 2016
Commodities classified under 18 specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for food or food additives. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered: Those food additives or foods classified under 18 specific CCC codes
Regulation Type: Regular notification
Import inspection requirement for commodities classified under 18 specific CCC codes if they are used for food or food additives
Distribution date: 26 April 2016 | Final date for Comment: 25 June 2016
Commodities classified under 18 specific CCC codes shall follow the "Regulations of Inspection of Imported Foods and Related Products" if they are used for food or food additives. The importers shall apply for inspection to the Food and Drug Administration, Ministry of Health and Welfare.
Products Covered: Those food additives or foods classified under 18 specific CCC codes
Regulation Type: Regular notification
<p>Notice of Intent to Amend the Prescription Drug List (PDL): Polymyxin B</p><p>The proposed amendment notified in G/TBT/N/CAN/470 (dated 16 October 2015) was adopted 2 April 2016.</p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL). Health Canada has conducted a scientific review of Polymyxin B against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p>This revision comes into effect on 22 April 2016 posted on the Health Canada website.</p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php</a> (French)</p><p>Or requested from:</p><p>Canada's Notification Authority and Enquiry Point <br />Global Affairs Canada <br />Technical Barriers and Regulations Division <br />111 Sussex Drive, Ottawa, ON K1A 0G2 <br />Tel: (343)203-4273 <br />Fax: 613-943-0346<br />E-mail: <a href="mailto:[email protected]">[email protected]</a></p>
Distribution date: 28 April 2016 | Final date for Comment: 02 May 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Addendum to Regular Notification
<p>Notice of Intent to Amend the Prescription Drug List (PDL): Polymyxin B</p><p>The proposed amendment notified in G/TBT/N/CAN/470 (dated 16 October 2015) was adopted 2 April 2016.</p><p>The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Polymyxin B to prescription status for veterinary use by adding it to the Veterinary Prescription Drug List (PDL). Health Canada has conducted a scientific review of Polymyxin B against the set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations.The wording remains unchanged from what was proposed in the Notice of Consultation.</p><p>This revision comes into effect on 22 April 2016 posted on the Health Canada website.</p><p>The full text of the adopted measure can be downloaded from the Internet addresses indicated below:<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-eng.php</a> (English)<br /><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl-ldo-noa-ad-polymyxinb-fra.php</a> (French)</p><p>Or requested from:</p><p>Canada's Notification Authority and Enquiry Point <br />Global Affairs Canada <br />Technical Barriers and Regulations Division <br />111 Sussex Drive, Ottawa, ON K1A 0G2 <br />Tel: (343)203-4273 <br />Fax: 613-943-0346<br />E-mail: <a href="mailto:[email protected]">[email protected]</a></p>
Distribution date: 28 April 2016 | Final date for Comment: 02 May 2025
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Addendum to Regular Notification
Proyecto de norma oficial mexicana PROY-NOM-138-SSA1-2015, que establece las especificaciones sanitarias del alcohol etílico desnaturalizado, utilizado como material de curación, así como para el alcohol etílico de 96ºg.l. sin desnaturalizar, utilizado como materia prima para la elaboración y/o envasado de alcohol etílico desnaturalizado como material de curación (Draft Mexican Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material, for undenatured 96° G.L. ethyl alcohol, used as a raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments) (11 pages, in Spanish) ;
Distribution date: 29 April 2016 | Final date for Comment: 28 June 2016
Ethyl alcohol, or ethanol, is one of the most widely used wound dressing materials, due to its antiseptic properties. However, given that ethyl alcohol can be easily obtained by the general population and is an addictive substance, it may be used inappropriately (ingested), and its consumption may lead to public health problems. Denaturing substances are therefore added to ethyl alcohol, such as denatonium benzoate, sucrose octaacetate and acetone, which give it an unpleasant taste. Nevertheless, it is necessary to issue provisions on the control and processing of this wound dressing material, in order to prevent it from being used for purposes other than those for which it is marketed, namely, to dress wounds. ; ;
Products Covered: Denatured ethyl alcohol (tariff heading: 22072001) ;
Regulation Type: Regular notification
Proyecto de norma oficial mexicana PROY-NOM-138-SSA1-2015, que establece las especificaciones sanitarias del alcohol etílico desnaturalizado, utilizado como material de curación, así como para el alcohol etílico de 96ºg.l. sin desnaturalizar, utilizado como materia prima para la elaboración y/o envasado de alcohol etílico desnaturalizado como material de curación (Draft Mexican Official Standard PROY-NOM-138-SSA1-2015 establishing the sanitary specifications for denatured ethyl alcohol, used as a wound dressing material, for undenatured 96° G.L. ethyl alcohol, used as a raw material in the production of denatured ethyl alcohol as a wound dressing material, and for packaging establishments) (11 pages, in Spanish) ;
Distribution date: 29 April 2016 | Final date for Comment: 28 June 2016
Ethyl alcohol, or ethanol, is one of the most widely used wound dressing materials, due to its antiseptic properties. However, given that ethyl alcohol can be easily obtained by the general population and is an addictive substance, it may be used inappropriately (ingested), and its consumption may lead to public health problems. Denaturing substances are therefore added to ethyl alcohol, such as denatonium benzoate, sucrose octaacetate and acetone, which give it an unpleasant taste. Nevertheless, it is necessary to issue provisions on the control and processing of this wound dressing material, in order to prevent it from being used for purposes other than those for which it is marketed, namely, to dress wounds. ; ;
Products Covered: Denatured ethyl alcohol (tariff heading: 22072001) ;
Regulation Type: Regular notification
Proyecto de Reglamento que regula la información mínima del documento que debe contener la validación de técnicas analíticas propias (Draft Regulation on the minimum information to be contained by the document required for the validation of analytical techniques specific to the manufacturer) (7 pages, in Spanish) ;
Distribution date: 02 May 2016 | Final date for Comment: 01 July 2016
The notified draft Regulation establishes the minimum information to be contained by the document required for the assessment of the validation of analytical techniques specific to the manufacturer, which are necessary for the registration and re-registration of and changes regarding pharmaceutical products in the sanitary register. ; ;
Products Covered: Pharmaceutical products, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
Proyecto de Reglamento que regula la información mínima del documento que debe contener la validación de técnicas analíticas propias (Draft Regulation on the minimum information to be contained by the document required for the validation of analytical techniques specific to the manufacturer) (7 pages, in Spanish) ;
Distribution date: 02 May 2016 | Final date for Comment: 01 July 2016
The notified draft Regulation establishes the minimum information to be contained by the document required for the assessment of the validation of analytical techniques specific to the manufacturer, which are necessary for the registration and re-registration of and changes regarding pharmaceutical products in the sanitary register. ; ;
Products Covered: Pharmaceutical products, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
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