Proposed Changes to the Tolerances for Arsenic and Lead in Fruit Juice, Fruit Nectar, Beverages when Ready-to-Serve, and Water in Sealed Containers

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Distribution date: 25 June 2014 | Final date for Comment: 02 September 2014

The Food Directorate's Bureau of Chemical Safety is proposing to update certain regulatory tolerances within Division 15 of the Food and Drugs Regulations, specifically those for arsenic and lead in a variety of beverages, including bottled water. Currently, Table 1 of Division 15 of the Food and Drug Regulations specifies tolerances of 0.1 parts per million (ppm) of arsenic and 0.2 ppm of lead in fruit juice, fruit nectar, beverages when ready-to-serve, and water in sealed containers other than mineral or spring water. Should these foods contain arsenic or lead at concentrations above these tolerances, they are considered to be adulterated and therefore may not be sold in Canada. Fruit juice makes a significant contribution to dietary lead and arsenic exposure, particularly in infants and young children. Therefore, this commodity group was identified as a priority for setting updated lead and arsenic tolerances. Health Canada is proposing to exclude apple juice from the existing tolerance for arsenic in fruit juice, fruit nectar, and beverages when ready-to-serve and create a lower tolerance of 0.01 ppm for total arsenic in apple juice. Health Canada is also proposing to lower the existing tolerance for lead in fruit juice, fruit nectar, and beverages when ready-to-serve to 0.05 ppm. Furthermore, Health Canada is recommending that the existing tolerances for both arsenic and lead in water in sealed containers be lowered to 0.01 ppm and extended to include all types of bottled water, including mineral and spring water, which have a standard of identity under Part B, Division 12 of the Food and Drug Regulations.

Products Covered: Tolerances for arsenic and lead in fruit juice, fruit nectar, beverages when ready-to-serve, and water in sealed containers (ICS Code: 67.160)

Regulation Type: Regular notification

Beverages Food safety Human health Heavy metals

Proposed Changes to the Tolerances for Arsenic and Lead in Fruit Juice, Fruit Nectar, Beverages when Ready-to-Serve, and Water in Sealed Containers

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Distribution date: 25 June 2014 | Final date for Comment: 02 September 2014

The Food Directorate's Bureau of Chemical Safety is proposing to update certain regulatory tolerances within Division 15 of the Food and Drugs Regulations, specifically those for arsenic and lead in a variety of beverages, including bottled water. Currently, Table 1 of Division 15 of the Food and Drug Regulations specifies tolerances of 0.1 parts per million (ppm) of arsenic and 0.2 ppm of lead in fruit juice, fruit nectar, beverages when ready-to-serve, and water in sealed containers other than mineral or spring water. Should these foods contain arsenic or lead at concentrations above these tolerances, they are considered to be adulterated and therefore may not be sold in Canada. Fruit juice makes a significant contribution to dietary lead and arsenic exposure, particularly in infants and young children. Therefore, this commodity group was identified as a priority for setting updated lead and arsenic tolerances. Health Canada is proposing to exclude apple juice from the existing tolerance for arsenic in fruit juice, fruit nectar, and beverages when ready-to-serve and create a lower tolerance of 0.01 ppm for total arsenic in apple juice. Health Canada is also proposing to lower the existing tolerance for lead in fruit juice, fruit nectar, and beverages when ready-to-serve to 0.05 ppm. Furthermore, Health Canada is recommending that the existing tolerances for both arsenic and lead in water in sealed containers be lowered to 0.01 ppm and extended to include all types of bottled water, including mineral and spring water, which have a standard of identity under Part B, Division 12 of the Food and Drug Regulations.

Products Covered: Tolerances for arsenic and lead in fruit juice, fruit nectar, beverages when ready-to-serve, and water in sealed containers (ICS Code: 67.160)

Regulation Type: Regular notification

Beverages Food safety Human health Heavy metals

Amendment to Enforcement Order of Industrial Safety and Health Law and related ordinances (1 page, in English)

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Distribution date: 27 June 2014 | Final date for Comment: 24 July 2014

<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="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Enforcement Order of Industrial Safety and Health Law and related ordinance</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s are to be partially amended to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">place obligations on the business operators </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">relating to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Dimethyl-2,2-dichlorovinylphosphate </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">(alias DDVP)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,<span>&nbsp;</span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Chloroform</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Carbon tetrachloride</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">4-Dioxane, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1,2-dichloroethane (alias ethylene chloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Dichloromethane (alias methylene dichloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Styrene</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">2</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">2-Tetrachloroethane (alias acethylene</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">tetrachloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Tetrachloroethylene </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">(alias</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">perchloroethylene)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Trichloroethylene<span style="font-face:Times New Roman;"> </span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">and </span></span><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Methyl isobutyl ketone</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span></span>

Products Covered: Dimethyl-2,2-dichlorovinylphosphate (alias DDVP) (2919.90), Chloroform (2903.13), Carbon tetrachloride (2903.14), 1,4-Dioxane (2909.20), 1,2- dichloroethane (alias ethylene chloride) (2903.15), Dichloromethane (alias methylene dichloride) (2903.12), Styrene (2902.50), 1,1,2,2-Tetrachloroethane (alias acethylene tetrachloride) (2903.19900), Tetrachloroethylene (alias perchloroethylene) (2903.23), Trichloroethylene (2903.22), Methyl isobutyl ketone (2914.13) (referred to as Dimethyl-2,2-dichlorovinylphosphate etc. ) and preparations containing them, etc.

Regulation Type: Regular notification

Human health

Amendment to Enforcement Order of Industrial Safety and Health Law and related ordinances (1 page, in English)

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Distribution date: 27 June 2014 | Final date for Comment: 24 July 2014

<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="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">The </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Enforcement Order of Industrial Safety and Health Law and related ordinance</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">s are to be partially amended to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">place obligations on the business operators </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">relating to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Dimethyl-2,2-dichlorovinylphosphate </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">(alias DDVP)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,<span>&nbsp;</span></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Chloroform</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Carbon tetrachloride</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">4-Dioxane, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1,2-dichloroethane (alias ethylene chloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Dichloromethane (alias methylene dichloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Styrene</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">1</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">2</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">,</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">2-Tetrachloroethane (alias acethylene</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">tetrachloride)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Tetrachloroethylene </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">(alias</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">perchloroethylene)</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">, </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Trichloroethylene<span style="font-face:Times New Roman;"> </span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;">and </span></span><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">Methyl isobutyl ketone</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">.</span></span></span></span><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:x-small;"><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;"></span></span></span></span>

Products Covered: Dimethyl-2,2-dichlorovinylphosphate (alias DDVP) (2919.90), Chloroform (2903.13), Carbon tetrachloride (2903.14), 1,4-Dioxane (2909.20), 1,2- dichloroethane (alias ethylene chloride) (2903.15), Dichloromethane (alias methylene dichloride) (2903.12), Styrene (2902.50), 1,1,2,2-Tetrachloroethane (alias acethylene tetrachloride) (2903.19900), Tetrachloroethylene (alias perchloroethylene) (2903.23), Trichloroethylene (2903.22), Methyl isobutyl ketone (2914.13) (referred to as Dimethyl-2,2-dichlorovinylphosphate etc. ) and preparations containing them, etc.

Regulation Type: Regular notification

Human health

Re-notification of newly added texts of Enforcement Regulation of Testing and Inspection of Food and Drugs Act

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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

Human health Food safety Certification, control and inspection Pharmaceutical products

Re-notification of newly added texts of Enforcement Regulation of Testing and Inspection of Food and Drugs Act

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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

Human health Food safety Certification, control and inspection Pharmaceutical products

Regulations amending Regulation Concerning Trade with Fertilisers, Liming Materials etc. (unofficial English translation, 2 pages)

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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&nbsp; 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&nbsp; 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

Human health

Regulations amending Regulation Concerning Trade with Fertilisers, Liming Materials etc. (unofficial English translation, 2 pages)

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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&nbsp; 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&nbsp; 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

Human health

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) ;

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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) ;

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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

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