Regulatory Updates
Partial amendment to the Minimum Requirements for Biological Products (1 page, in English)
Distribution date: 20 May 2014 | Final date for Comment: 20 June 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">is to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard for a blood product </span><span style="font-size:x-small;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">to be newly approved.</span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 page, in English)
Distribution date: 20 May 2014 | Final date for Comment: 20 June 2014
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">The Minimum Requirements for Biological Products </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">is to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">be partially amended to add the standard for a blood product </span><span style="font-size:x-small;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">to be newly approved.</span></span></span></span></span></span></span></span>
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
Turkish Food Codex Communiqué on Coffee and Coffee Extracts (6 pages, in Turkish)
Distribution date: 19 May 2014 | Final date for Comment: 18 July 2014
<p>Turkish Food Codex Communiqué on Coffee and Coffee Extracts has been prepared in compliance with the Council Directive 1999/4 relating to coffee and coffee extracts. The Communiqué covers the provisions on definitions of green coffee beans, roasted coffee beans and ground coffee; chemical properties of ground coffee; chemical and physical characteristics of coffee extract, soluble coffee extract, soluble coffee or instant coffee. However, it does not cover café torrefacto soluble, other coffee products and chicory extracts.<br />In this Communiqué, additional provisions are excerpted from other international regulations on coffee beans and necessary for execution of national arrangements on production, import and inspections of these products more efficiently; since coffee beans, roasted coffee beans and ground coffee are widely consumed in Turkey.<span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Times New Roman','serif';font-size:11pt;"></span></p>
Products Covered: The Communiqué covers green coffee beans, roasted coffee beans, ground coffee and coffee extract, soluble coffee extract, soluble coffee and instant coffee.
Regulation Type: Regular notification
Turkish Food Codex Communiqué on Coffee and Coffee Extracts (6 pages, in Turkish)
Distribution date: 19 May 2014 | Final date for Comment: 18 July 2014
<p>Turkish Food Codex Communiqué on Coffee and Coffee Extracts has been prepared in compliance with the Council Directive 1999/4 relating to coffee and coffee extracts. The Communiqué covers the provisions on definitions of green coffee beans, roasted coffee beans and ground coffee; chemical properties of ground coffee; chemical and physical characteristics of coffee extract, soluble coffee extract, soluble coffee or instant coffee. However, it does not cover café torrefacto soluble, other coffee products and chicory extracts.<br />In this Communiqué, additional provisions are excerpted from other international regulations on coffee beans and necessary for execution of national arrangements on production, import and inspections of these products more efficiently; since coffee beans, roasted coffee beans and ground coffee are widely consumed in Turkey.<span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Times New Roman','serif';font-size:11pt;"></span></p>
Products Covered: The Communiqué covers green coffee beans, roasted coffee beans, ground coffee and coffee extract, soluble coffee extract, soluble coffee and instant coffee.
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Absorbent cotton gauze and absorbent cotton and viscose gauze (20 pages, in English; 5 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<p style="margin-top:6pt;">Revision of the Mandatory Standard SI 915 and all its amendments to be replaced with SI 14079 part 1. This draft standard revision adopts the European Standard EN 14079: April 2003 and therefore differs significantly from the old version. This new revised draft expands the standard's scope to include gauze made from cotton and viscose.</p><p>In addition, the standard's Hebrew section adds a new paragraph 4.16, which specifies the requirements for marking and packaging.</p><li></li>
Products Covered: Medical gauze
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Absorbent cotton gauze and absorbent cotton and viscose gauze (20 pages, in English; 5 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<p style="margin-top:6pt;">Revision of the Mandatory Standard SI 915 and all its amendments to be replaced with SI 14079 part 1. This draft standard revision adopts the European Standard EN 14079: April 2003 and therefore differs significantly from the old version. This new revised draft expands the standard's scope to include gauze made from cotton and viscose.</p><p>In addition, the standard's Hebrew section adds a new paragraph 4.16, which specifies the requirements for marking and packaging.</p><li></li>
Products Covered: Medical gauze
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Gauze bandage (5 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<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 997 to be replaced with SI 14079 part 2. Among the major differences introduced in this new revised draft standard we wish to emphasize the following:</span></span></span></p><ul><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Deletes the requirements to classify and mark the gauzes according to string density and instead requires that the number of strings in 1 cm<sup>2</sup>, not be less than 17 (warp and woof).</span></span></span></li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Requires that the gauze bandage <span> </span>comply also with Israel Mandatory Standard SI 14079 part 1.</span></span></span></li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">Refers to Israel Mandatory Standard SI 14079 part 1 for the test methods.</span></span></li></ul><p></p>
Products Covered: Gauze bandage
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Gauze bandage (5 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<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 997 to be replaced with SI 14079 part 2. Among the major differences introduced in this new revised draft standard we wish to emphasize the following:</span></span></span></p><ul><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Deletes the requirements to classify and mark the gauzes according to string density and instead requires that the number of strings in 1 cm<sup>2</sup>, not be less than 17 (warp and woof).</span></span></span></li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Requires that the gauze bandage <span> </span>comply also with Israel Mandatory Standard SI 14079 part 1.</span></span></span></li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">Refers to Israel Mandatory Standard SI 14079 part 1 for the test methods.</span></span></li></ul><p></p>
Products Covered: Gauze bandage
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Gauze pad (21 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<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 997 to be replaced with SI 14079 part 3. Among the major differences introduced in this new revised draft standard we wish to emphasize the following:</span></span></span></p><ul><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Requires that the gauze pads be marked "sterilized" according to the requirements of Israel Standard SI 4151 (paragraph 2.3.10) and that manufacturers provide the testing laboratory with a declaration that the gauze pads were sterilized according to </span></span></span>Israel Standard SI 11607 parts 1 and 2 or according to the adopted ISO Standards 11607 parts 1 and 2 (paragraph 2.6.2).</li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Refers to Israel Mandatory Standard SI 14079 part 1 for the sulphur ash content.</span></span></span></li></ul><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span></p>
Products Covered: Gauze pad
Regulation Type: Regular notification
Non-active medical devices - Performance requirements and test methods: Gauze pad (21 pages, in Hebrew).
Distribution date: 14 May 2014 | Final date for Comment: 13 July 2014
<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 997 to be replaced with SI 14079 part 3. Among the major differences introduced in this new revised draft standard we wish to emphasize the following:</span></span></span></p><ul><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Requires that the gauze pads be marked "sterilized" according to the requirements of Israel Standard SI 4151 (paragraph 2.3.10) and that manufacturers provide the testing laboratory with a declaration that the gauze pads were sterilized according to </span></span></span>Israel Standard SI 11607 parts 1 and 2 or according to the adopted ISO Standards 11607 parts 1 and 2 (paragraph 2.6.2).</li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>Refers to Israel Mandatory Standard SI 14079 part 1 for the sulphur ash content.</span></span></span></li></ul><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span></p>
Products Covered: Gauze pad
Regulation Type: Regular notification
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