Regulatory Updates

Commission Implementing Regulation (EU) No 1021/2014 of 26 September 2014 amending Annex I to Regulation (EC) No 669/2009 Implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin (Text with EEA relevance)

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Distribution date: 07 October 2014

The Regulation reviews the list of imports of feed and food of non-animal origin which are subject to an increased level of official controls. The changes concern the removal of the following products from the list: frozen strawberries and pomelos from China. The changes also concern the inclusion of the following products in the list: aubergines, Chinese celery and yardlong beans from Cambodia; sesamum seeds from India, and dragon fruit from Viet Nam.

Products Covered: HS Code(s): ex 07049090, ex 07081000, ex 07082000, 07096010, 07093000, ex 07094000, 07096010, ex 07096099, ex 07099990, ex 07102200, 071022, 07108051, ex 07108059, ex 07108095, 07133900, 08051020, 08051080, ex 08054000, 08061010, 080620, 08101000, ex 08109020, 081110, 08131000, 0902, 090420, 09042110, 09042190, ex 09042200, 09081100, 09081200, 091050, 09109105, ex 11063090, 12024100, 12024200, 12074090, ex 12077000, ex 12119086, ex 14049000, 20081110, 20081191, 20081196, 20081198, ex 20089999, 3507

Regulation Type: Regular notification

Food safety Contaminants Mycotoxins Salmonella Bacteria Toxins Animal feed Human health Aflatoxins Ochratoxin Food additives

<p><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): Naproxen</span></span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/415 (dated 12 June 2014) was adopted 25 September&nbsp;2014.</span></span></p><p align="left"><span style="font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">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 naproxen on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of naproxen against a set of established and publicly available criteria 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 Notice of Consultation.</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;">This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</span></span><span lang="EN"> </span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></span></p><p><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_naproxen-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noa_ad_naproxen-eng.php</a></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">(English)</span></span></p><p><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_naproxen-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noa_ad_naproxen-fra.php</a></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">(French)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">or requested from:</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Canada's Notification Authority and Enquiry Point</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Foreign Affairs, Trade and Development Canada</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:9pt;">Technical Barriers and Regulations Division</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">111, promenade Sussex Drive</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Ottawa, ON K1A 0G2</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Canada</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Tel / Tél: (343) 203-4273</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Fax / Téléc: 613-943-0346</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="FR" style="font-size:9pt;">E-mail / Courriel: </span><span lang="EN-GB"><a href="mailto:[email protected]"><span lang="FR">[email protected]</span></a></span></span></p><p align="left"><span style="font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;"></span></span></p><p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span></p>

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Distribution date: 02 October 2014

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

Regulation Type: Addendum to Regular Notification

<p><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): Naproxen</span></span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/415 (dated 12 June 2014) was adopted 25 September&nbsp;2014.</span></span></p><p align="left"><span style="font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;">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 naproxen on the Prescription Drug List (PDL). Only the Human part of the PDL is to be revised; the listing for Veterinary use will remain unchanged. Health Canada has conducted a scientific review of naproxen against a set of established and publicly available criteria 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 Notice of Consultation.</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;">This revision will be in effect six months from the date of this Notice posted on the Health Canada website.</span></span><span lang="EN"> </span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below:</span></span></p><p><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_naproxen-eng.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noa_ad_naproxen-eng.php</a></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">(English)</span></span></p><p><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_naproxen-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noa_ad_naproxen-fra.php</a></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">(French)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">or requested from:</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Canada's Notification Authority and Enquiry Point</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Foreign Affairs, Trade and Development Canada</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:9pt;">Technical Barriers and Regulations Division</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">111, promenade Sussex Drive</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">Ottawa, ON K1A 0G2</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Canada</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Tel / Tél: (343) 203-4273</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">Fax / Téléc: 613-943-0346</span></span></p><p align="left"><span style="font-size:x-small;font-face:Verdana;"><span lang="FR" style="font-size:9pt;">E-mail / Courriel: </span><span lang="EN-GB"><a href="mailto:[email protected]"><span lang="FR">[email protected]</span></a></span></span></p><p align="left"><span style="font-size:small;font-face:Verdana;"><span lang="EN" style="font-size:9.5pt;"></span></span></p><p><span style="text-decoration:underline;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span></p>

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Distribution date: 02 October 2014

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

Regulation Type: Addendum to Regular Notification

; ;The Republic of Ecuador hereby advises that Technical Regulation (RTE) No. 164 "Waxes for floors and polishes" of the Ecuadorian Standardization Institute (INEN), the draft version of which was notified in document G/TBT/N/ECU/167 of 11 February 2014, has been issued pursuant to Resolution No. 14 367 of 13 August 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 330 of Wednesday 10 September 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;E-mail: [email protected] / [email protected] ; ;

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Distribution date: 01 October 2014

Products Covered: HS tariff subheadings 3405.10.00, 3405.20.00 and 3405.90.00 ;

Regulation Type: Addendum to Regular Notification

; ;The Republic of Ecuador hereby advises that Technical Regulation (RTE) No. 164 "Waxes for floors and polishes" of the Ecuadorian Standardization Institute (INEN), the draft version of which was notified in document G/TBT/N/ECU/167 of 11 February 2014, has been issued pursuant to Resolution No. 14 367 of 13 August 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 330 of Wednesday 10 September 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;E-mail: [email protected] / [email protected] ; ;

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Distribution date: 01 October 2014

Products Covered: HS tariff subheadings 3405.10.00, 3405.20.00 and 3405.90.00 ;

Regulation Type: Addendum to Regular Notification

Proposed Hazardous Products Regulations (138 pages, in English and French)

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Distribution date: 25 September 2014 | Final date for Comment: 26 October 2014

<p>The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) created by the United Nations, is designed to replace the different classification and labeling standards used in various countries. It uses globally consistent criteria for the classification and labeling of hazardous chemicals.</p><p>Canada’s adoption of the GHS necessitated the amendment of the <em>Hazardous Products Act</em> (HPA). Under the authority of the amended HPA, it is proposed that the <em>Controlled Products Regulations</em> on which Canada’s current hazard communication standard is based be repealed and replaced with new regulations based on the GHS, to be titled the <em>Hazardous Products Regulations </em>(HPR). In addition, consequential amendments are proposed to the <em>Hazardous Materials Information Review Regulations and Hazardous Materials Information Review Act Appeal Board Procedures Regulations</em> to reflect changes to the <em>Hazardous Materials Information Review Act</em> that came into force on April 1, 2013, as a result of the <em>Jobs and Growth Act, 2012</em>.</p><p>The proposed regulatory amendments would support the Government of Canada in facilitating international trade through common labeling and other hazard communication requirements; lowering costs for businesses and consumers by reducing the need for re-testing and re-classifying chemicals from, or for, different markets; and increasing worker protections through the adoption of a globally recognized standard for communicating the hazards associated with workplace chemicals.<br /></p>

Products Covered: Chemicals (ICS: 13.020, 71.100) (HS: 28, 29)

Regulation Type: Regular notification

Proposed Hazardous Products Regulations (138 pages, in English and French)

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Distribution date: 25 September 2014 | Final date for Comment: 26 October 2014

<p>The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) created by the United Nations, is designed to replace the different classification and labeling standards used in various countries. It uses globally consistent criteria for the classification and labeling of hazardous chemicals.</p><p>Canada’s adoption of the GHS necessitated the amendment of the <em>Hazardous Products Act</em> (HPA). Under the authority of the amended HPA, it is proposed that the <em>Controlled Products Regulations</em> on which Canada’s current hazard communication standard is based be repealed and replaced with new regulations based on the GHS, to be titled the <em>Hazardous Products Regulations </em>(HPR). In addition, consequential amendments are proposed to the <em>Hazardous Materials Information Review Regulations and Hazardous Materials Information Review Act Appeal Board Procedures Regulations</em> to reflect changes to the <em>Hazardous Materials Information Review Act</em> that came into force on April 1, 2013, as a result of the <em>Jobs and Growth Act, 2012</em>.</p><p>The proposed regulatory amendments would support the Government of Canada in facilitating international trade through common labeling and other hazard communication requirements; lowering costs for businesses and consumers by reducing the need for re-testing and re-classifying chemicals from, or for, different markets; and increasing worker protections through the adoption of a globally recognized standard for communicating the hazards associated with workplace chemicals.<br /></p>

Products Covered: Chemicals (ICS: 13.020, 71.100) (HS: 28, 29)

Regulation Type: Regular notification

; ;The Republic of Ecuador hereby advises that Technical Regulation (RTE) No. 163 "Candles, tapers and the like" of the Ecuadorian Standardization Institute (INEN), the draft version of which was notified in document G/TBT/N/ECU/166 of 11 February 2014, has been issued pursuant to Resolution No. 14 368 of 13 August 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 330 of Wednesday 10 September 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;E-mail: [email protected]; [email protected] ; ;

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Distribution date: 24 September 2014

Products Covered: HS tariff subheading 3406.00.00 ;

Regulation Type: Addendum to Regular Notification

; ;The Republic of Ecuador hereby advises that Technical Regulation (RTE) No. 163 "Candles, tapers and the like" of the Ecuadorian Standardization Institute (INEN), the draft version of which was notified in document G/TBT/N/ECU/166 of 11 February 2014, has been issued pursuant to Resolution No. 14 368 of 13 August 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 330 of Wednesday 10 September 2014. ; ;Text available from: ; ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;E-mail: [email protected]; [email protected] ; ;

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Distribution date: 24 September 2014

Products Covered: HS tariff subheading 3406.00.00 ;

Regulation Type: Addendum to Regular Notification

; ;The Republic of Ecuador hereby advises that Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 146: "Colour and transparency of printing ink sets", the draft version of which was notified in document G/TBT/N/ECU/182 of 17 February 2014, has been issued pursuant to Resolution No. 14 351 of 30 July 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 320 of 27 August 2014. ;Text available from: Ministerio de Industrias y Productividad (Ministry of Industry and Productivity), Subsecretaría de la Calidad (Under-Secretariat for Quality), Organismo Nacional encargado de la Notificación (National Notification Authority): ;Contact person: ;Marlon Martínez B. ;Yánez Pinzón N26-12, entre Av. Colón y La Niña ;Quito, Ecuador ;Tel.: (+593) 2 394-8760, Ext. 2255/2253 ;Email: [email protected] / [email protected] ; ; ;

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Distribution date: 23 September 2014

Products Covered: 3215.19.00 ;

Regulation Type: Addendum to Regular Notification

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