Regulatory Updates

Non-active medical devices - Performance requirements and test methods: Gauze pad (21 pages, in Hebrew).

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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.&nbsp;Among the&nbsp;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&nbsp;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

Human health

Draft Resolution on the registration of veterinary feed supplements

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Distribution date: 13 May 2014

Please be advised that the draft text notified in document G/SPS/N/ARG/161 of 31 October 2012 has been adopted as National Agriculture and Food Quality and Health Service (SENASA) Resolution No. 149/2014. The measure was published in the Official Journal of the Argentine Republic on 3 February 2014 and the full text is available for consultation at http://www.infoleg.gob.ar/infolegInternet/anexos/225000-229999/228638/norma.htm.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Draft Resolution on the registration of veterinary feed supplements

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Distribution date: 13 May 2014

Please be advised that the draft text notified in document G/SPS/N/ARG/161 of 31 October 2012 has been adopted as National Agriculture and Food Quality and Health Service (SENASA) Resolution No. 149/2014. The measure was published in the Official Journal of the Argentine Republic on 3 February 2014 and the full text is available for consultation at http://www.infoleg.gob.ar/infolegInternet/anexos/225000-229999/228638/norma.htm.

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Turkish Food Codex Communiqué on Coffee and Coffee Extracts

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Distribution date: 12 May 2014 | Final date for Comment: 11 July 2014

This Communiqué has been prepared in compliance with the Council Directive 1999/4 on coffee and coffee extracts. The Communiqué covers: green coffee beans, roasted coffee beans, ground coffee and coffee extract, soluble coffee extract, soluble coffee and instant coffee. Furthermore, this Communiqué covers the provisions on definitions of green coffee beans, roasted coffee beans and ground coffee, chemical properties of ground coffee. It also covers the chemical and physical characteristics of coffee extract, soluble coffee extract, soluble coffee or instant coffee. It does not cover "café torrefacto soluble", other coffee products and chicory extracts.

Products Covered: Coffee and coffee extracts

Regulation Type: Regular notification

Food safety Human health

Turkish Food Codex Communiqué on Coffee and Coffee Extracts

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Distribution date: 12 May 2014 | Final date for Comment: 11 July 2014

This Communiqué has been prepared in compliance with the Council Directive 1999/4 on coffee and coffee extracts. The Communiqué covers: green coffee beans, roasted coffee beans, ground coffee and coffee extract, soluble coffee extract, soluble coffee and instant coffee. Furthermore, this Communiqué covers the provisions on definitions of green coffee beans, roasted coffee beans and ground coffee, chemical properties of ground coffee. It also covers the chemical and physical characteristics of coffee extract, soluble coffee extract, soluble coffee or instant coffee. It does not cover "café torrefacto soluble", other coffee products and chicory extracts.

Products Covered: Coffee and coffee extracts

Regulation Type: Regular notification

Food safety Human health

Letter of the Federal Service for Veterinary and Phytosanitary Supervision No. FS-EN-8/7351 as of 5 May 2014

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Distribution date: 12 May 2014

In connection with the worsening of epizootic situation in Latvia on classical swine fever (CSF) and repeated cases of registration of the mentioned disease on the territory of Dagdas, Kraslavas and Zilupes municipalities in Latvia, in accordance with the information of the World Organization for Animal Health (OIE) as of 15 April 2014, a temporary restriction was introduced on certain products from Latvia. This measure applies on import of: - pedigree pigs; - boars sperm; - pork and pork meat products; - meat of wild boars; - hunting trophies made from susceptible kinds of animals, which were not subjected to full taxidermy treatment; - all types of feed and feed additives (excluding feed additives of chemical and microbiological synthesis and prepared feed for cats and dogs that were properly heat treated, i.e. no less than 70C for at least 20 min); - previously used equipment for maintenance, slaughter and cutting of pigs.

Products Covered: Pedigree pigs, boars sperm, pork and pork meat products, meat of wild boars, hunting trophies made from susceptible kinds of animals, all types of feed and feed additives (excluding feed additives of chemical and microbiological synthesis and prepared feed for cats and dogs), previously used equipment for maintenance, slaughter and cutting of pigs

Regulation Type: Emergency notifications (SPS)

Animal diseases Classical Swine Fever Feed additives Bovine Spongiform Encephalopathy (BSE) Animal feed Animal health Pest- or Disease- free Regions / Regionalization

Letter of the Federal Service for Veterinary and Phytosanitary Supervision No. FS-EN-8/7351 as of 5 May 2014

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Distribution date: 12 May 2014

In connection with the worsening of epizootic situation in Latvia on classical swine fever (CSF) and repeated cases of registration of the mentioned disease on the territory of Dagdas, Kraslavas and Zilupes municipalities in Latvia, in accordance with the information of the World Organization for Animal Health (OIE) as of 15 April 2014, a temporary restriction was introduced on certain products from Latvia. This measure applies on import of: - pedigree pigs; - boars sperm; - pork and pork meat products; - meat of wild boars; - hunting trophies made from susceptible kinds of animals, which were not subjected to full taxidermy treatment; - all types of feed and feed additives (excluding feed additives of chemical and microbiological synthesis and prepared feed for cats and dogs that were properly heat treated, i.e. no less than 70C for at least 20 min); - previously used equipment for maintenance, slaughter and cutting of pigs.

Products Covered: Pedigree pigs, boars sperm, pork and pork meat products, meat of wild boars, hunting trophies made from susceptible kinds of animals, all types of feed and feed additives (excluding feed additives of chemical and microbiological synthesis and prepared feed for cats and dogs), previously used equipment for maintenance, slaughter and cutting of pigs

Regulation Type: Emergency notifications (SPS)

Animal diseases Classical Swine Fever Feed additives Bovine Spongiform Encephalopathy (BSE) Animal feed Animal health Pest- or Disease- free Regions / Regionalization

National Standard of the P.R.C., Safety of Toys¡ªPart 13: Chemical Toys (Sets) other than Experimental Sets£¨80 pages, in Chinese£©

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Distribution date: 07 May 2014 | Final date for Comment: 06 July 2014

<span lang="EN-US" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:CenturySchoolbook;mso-ansi-language:EN-US;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">This standard specifies the requirements and test methods for the substances and materials used in chemical toys (sets) other than experimental sets.</span>

Products Covered: Toys ; ICS: 97.200.50 HS: 9503 ;

Regulation Type: Regular notification

National Standard of the P.R.C., Safety of Toys¡ªPart 13: Chemical Toys (Sets) other than Experimental Sets£¨80 pages, in Chinese£©

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Distribution date: 07 May 2014 | Final date for Comment: 06 July 2014

<span lang="EN-US" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:CenturySchoolbook;mso-ansi-language:EN-US;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">This standard specifies the requirements and test methods for the substances and materials used in chemical toys (sets) other than experimental sets.</span>

Products Covered: Toys ; ICS: 97.200.50 HS: 9503 ;

Regulation Type: Regular notification

Memorandum 2013-03: Bilingual Labelling of veterinary biologics

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Distribution date: 05 May 2014 | Final date for Comment: 25 June 2014

The CFIA intends to amend Subsection 134 (3) of the Health of Animals Regulations in order to require fully bilingual (i.e., English and French) labelling for veterinary biologics imported into or sold, advertised, or offered for sale in Canada. (Currently, labels for veterinary biologics imported into or sold, advertised or offered for sale may be shown in either or both official languages.) The current exemptions for unlicensed veterinary biologics imported for research or emergency use will be maintained. This amendment is to ensure that information related to health and safety is available to Canadians in their official language of choice. This measure has been notified under the TBT Agreement.

Products Covered: Veterinary biologics (ICS Codes: 11.220, 65.020, 55.200)

Regulation Type: Regular notification

Labelling Animal health Veterinary drugs

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