Regulatory Updates
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)
Distribution date: 16 July 2014 | Final date for Comment: 14 September 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Dimethomorph.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10 and 07.13) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.04, 08.05, 08.06, 08.07, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.10) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This addendum aims at amending the Conformity Assessment Procedures for Safety Matches issued by the National Institute of Metrology, Quality and Technology (INMETRO) as Ordinance Nº 641, 30 November 2012 (Portaria 641 de 30 de Novembro de 2012), and notified under the document G/TBT/N/504/Add.1, by rewords items 4º, 5º, 9º and 10º for safety reasons, as well as to revoke Ordinance Nº 188, 22 June 2009 (Portaria Nº 188, de 22 de Junho de 2009) and Ordinance<span> </span>Nº 338, 11 November 2009 (Portaria Nº 338, de 11 de Novembro de 2009).</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text is available in Portuguese and can be downloaded at:</span></span></p> ; ;http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC002125.pdf
Distribution date: 10 July 2014
Products Covered: Matches (HS 3605).
Regulation Type: Addendum to Regular Notification
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This addendum aims at amending the Conformity Assessment Procedures for Safety Matches issued by the National Institute of Metrology, Quality and Technology (INMETRO) as Ordinance Nº 641, 30 November 2012 (Portaria 641 de 30 de Novembro de 2012), and notified under the document G/TBT/N/504/Add.1, by rewords items 4º, 5º, 9º and 10º for safety reasons, as well as to revoke Ordinance Nº 188, 22 June 2009 (Portaria Nº 188, de 22 de Junho de 2009) and Ordinance<span> </span>Nº 338, 11 November 2009 (Portaria Nº 338, de 11 de Novembro de 2009).</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The full text is available in Portuguese and can be downloaded at:</span></span></p> ; ;http://www.inmetro.gov.br/legislacao/rtac/pdf/RTAC002125.pdf
Distribution date: 10 July 2014
Products Covered: Matches (HS 3605).
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): Hydrocortisone</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/408 (dated 5 March 2014) was adopted 3 June 2014.</span></span></p><p align="left"><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;">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 hydrocortisone 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 hydrocortisone against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em><em><span style="font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';">Food and Drug Regulations</span></span></em></em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</span></span></p><p align="left"><span style="color:black;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></p><p align="left"><span style="line-height:1.5;font-family:Verdana;font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below: </span></p><p align="left"><span style="line-height:1.5;font-family:Verdana;font-size:9pt;"></span><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-eng.php" style="line-height:1.5;font-family:Verdana;font-size:9pt;">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-eng.php</a><span style="line-height:1.5;font-family:Verdana;font-size:9pt;"> (English)</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_noi_adi_hydrocortisone-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-fra.php</a></span> </span>(French)</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;">Canadas SPS & TBT 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 lang="EN-GB" style="font-size:9pt;">Technical Barriers and Regulations Division (TIB)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">111 Sussex Drive, 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;">Telephone: (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: (613)943-0346</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">E-mail: enquirypoint@international.gc.ca</span></span></p><p align="left"><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;"></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span></span><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>
Distribution date: 09 July 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): Hydrocortisone</span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The proposed amendment notified in G/TBT/N/CAN/408 (dated 5 March 2014) was adopted 3 June 2014.</span></span></p><p align="left"><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;">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 hydrocortisone 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 hydrocortisone against a set of established and publicly available criteria outlined in section C.01.040.3 of the <em><em><span style="font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';">Food and Drug Regulations</span></span></em></em>. The wording remains unchanged from what was proposed in the Notice of Consultation.</span></span></p><p align="left"><span style="color:black;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></p><p align="left"><span style="line-height:1.5;font-family:Verdana;font-size:9pt;">The full text of the adopted measure can be downloaded from the Internet addresses indicated below: </span></p><p align="left"><span style="line-height:1.5;font-family:Verdana;font-size:9pt;"></span><a href="http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-eng.php" style="line-height:1.5;font-family:Verdana;font-size:9pt;">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-eng.php</a><span style="line-height:1.5;font-family:Verdana;font-size:9pt;"> (English)</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_noi_adi_hydrocortisone-fra.php">http://www.hc-sc.gc.ca/dhp-mps/prodpharma/pdl-ord/pdl_ldo_noi_adi_hydrocortisone-fra.php</a></span> </span>(French)</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;">Canadas SPS & TBT 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 lang="EN-GB" style="font-size:9pt;">Technical Barriers and Regulations Division (TIB)</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">111 Sussex Drive, 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;">Telephone: (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: (613)943-0346</span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="FR-CA" style="font-size:9pt;">E-mail: enquirypoint@international.gc.ca</span></span></p><p align="left"><span style="color:black;font-size:x-small;font-face:Verdana;"><span lang="EN" style="font-size:9pt;"></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;"></span></span><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>
Distribution date: 09 July 2014
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Addendum to Regular Notification
Proyecto de PRTE INEN 238, "Emulsiones Adhesivas de Acetato de Polivinyl (PVA)" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 238: "Polyvinyl acetate (PVA) emulsion adhesives") (6 pages, in Spanish) ;
Distribution date: 07 July 2014 | Final date for Comment: 05 September 2014
The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Classification; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;
Products Covered: 3506.10.00. Products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg (HS 350610). ;
Regulation Type: Regular notification
Proyecto de PRTE INEN 238, "Emulsiones Adhesivas de Acetato de Polivinyl (PVA)" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 238: "Polyvinyl acetate (PVA) emulsion adhesives") (6 pages, in Spanish) ;
Distribution date: 07 July 2014 | Final date for Comment: 05 September 2014
The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Classification; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;
Products Covered: 3506.10.00. Products suitable for use as glues or adhesives, put up for retail sale as glues or adhesives, not exceeding a net weight of 1 kg (HS 350610). ;
Regulation Type: Regular notification
Regulations amending Regulation Concerning Trade with Fertilisers, Liming Materials etc. (unofficial English translation, 2 pages)
Distribution date: 04 July 2014 | Final date for Comment: 02 September 2014
<p>Amendments of the national safety-requirements for ammonium nitrate fertilisers of high nitrogen content. </p><p>Through Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 implemented by the Norwegian regulations 30. May 2008 No. 516 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) some of the technical provisions for all ammonium nitrate fertilisers in the EEA area are harmonised. </p><p>Norway also has decided to adapt the national regulation to some of the other provisions in articles 25 to 28 of Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers. </p><p>This is in order to streamline the handling of ammonium nitrate fertilisers of high nitrogen content independently of the regulation under which it is marketed. </p><p>In order to facilitate the control of the fertilisers we also propose a new requirement for certain information to be submitted with the test of resistance to detonation.</p><p>The following new requirements are proposed: <br />·submission of an analysis-report on the test of resistance to detonation to the Norwegian Directorate for Civil Protection at least 5 days before the arrival of the fertiliser at the Norwegian borders in the following cases:</p><p>- the fertiliser is imported from countries outside the EEA-area.<br />- the fertiliser is imported from countries in the EEA-area and has not earlier been placed on the marked in an EEA-country.</p><p>·analysis being performed by approved laboratories <br />·submission of certain information about the products which are to be imported or placed on the market in Norway<br />·ammonium nitrate fertilisers of high nitrogen content shall be made available to the final user only in packaged form.</p>
Products Covered: Fertiliser HS 31.02
Regulation Type: Regular notification
Regulations amending Regulation Concerning Trade with Fertilisers, Liming Materials etc. (unofficial English translation, 2 pages)
Distribution date: 04 July 2014 | Final date for Comment: 02 September 2014
<p>Amendments of the national safety-requirements for ammonium nitrate fertilisers of high nitrogen content. </p><p>Through Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 implemented by the Norwegian regulations 30. May 2008 No. 516 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) some of the technical provisions for all ammonium nitrate fertilisers in the EEA area are harmonised. </p><p>Norway also has decided to adapt the national regulation to some of the other provisions in articles 25 to 28 of Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers. </p><p>This is in order to streamline the handling of ammonium nitrate fertilisers of high nitrogen content independently of the regulation under which it is marketed. </p><p>In order to facilitate the control of the fertilisers we also propose a new requirement for certain information to be submitted with the test of resistance to detonation.</p><p>The following new requirements are proposed: <br />·submission of an analysis-report on the test of resistance to detonation to the Norwegian Directorate for Civil Protection at least 5 days before the arrival of the fertiliser at the Norwegian borders in the following cases:</p><p>- the fertiliser is imported from countries outside the EEA-area.<br />- the fertiliser is imported from countries in the EEA-area and has not earlier been placed on the marked in an EEA-country.</p><p>·analysis being performed by approved laboratories <br />·submission of certain information about the products which are to be imported or placed on the market in Norway<br />·ammonium nitrate fertilisers of high nitrogen content shall be made available to the final user only in packaged form.</p>
Products Covered: Fertiliser HS 31.02
Regulation Type: Regular notification
Re-notification of newly added texts of Enforcement Regulation of Testing and Inspection of Food and Drugs Act
Distribution date: 27 June 2014 | Final date for Comment: 11 July 2014
The proposed Enactment of the Enforcement Regulation of Testing and Inspection of Food and Drugs Act was already notified to WTO in 11 December 2013 for comment. In the meantime, it was decided that current provisions of existing notifications exercised by the Minister of Food and Drug Safety should be consolidated into the previously notified Enactments for better clarification of the legal status in line with the Enforcement Regulation, by upgrading the text in MFDS notifications into the Enforcement Regulation. As a result, the current regulations in the MFDS notifications were incorporated into the Annexes of the previously proposed Enactment of the Enforcement Regulation. Key features of the proposed texts shall be those of current texts of the notifications and minor changes were made to expand the designating scope of the testing laboratory to allow Livestock Products Testing in addition to the Food Testing laboratories with regards to Foreign Official Laboratories. User fee system introduced was already notified to WTO in 11 December 2013.
Products Covered: Testing laboratories (food, livestock products, pharmaceuticals, traditional Korean medicinal substances, medical devices, cosmetics)
Regulation Type: Regular notification
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