Regulatory Updates

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

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

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

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

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

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

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

Distribution date: 23 June 2014 | Final date for Comment: 22 August 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; 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: 3604.10.00 and 3604.90.00 ;

Regulation Type: Regular notification

Distribution date: 23 June 2014 | Final date for Comment: 22 August 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; 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: 3604.10.00 and 3604.90.00 ;

Regulation Type: Regular notification

Distribution date: 20 June 2014 | Final date for Comment: 08 August 2014

Draft resolution of the pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia. The heparin sodium from bovine is extracted from the bovine intestine and contains a mix of polysaccharide chains with different molecular weight. It is composed of units of &#61537;-D-glucosamine and acid &#61537;&#61485;iduronic 2-sulfated. The units of &#61537;-D-glucosamine present a more heterogeneous pattern of sulphatation in comparison with the heparin from porcine. In special we observe higher proportion of units of &#61537;-D-glucosamine non-sulphated in the position 6. It has anticoagulant activity by the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 160 units of anti-factor lla activity for mg of heparin, respectively, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be of 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species and the manufacturing process must ensure the elimination or the inactivation of infectious agents. The heparin sodium from porcine is extracted from the intestine of the porcine and contains a mix of polysaccharide chains with different molecular weight. It is composed, preponderantly, for alternated units of &#61537;-D-glucosamine N- and 6- disulfated and acid &#61537;&#61485;iduronic 2-sulfated. It has anticoagulant activity due to the inhibition of many factors of the coagulation system, prolonging the time of coagulation in blood. This occurs mainly through potentiation of the Xa factor inactivation and of the thrombin through the antithrombin. It contains, at least, 180 units of anti-factor lla activity for mg of heparin, in relation to desiccated substance. The reason of the anti-factor Xa activity for the anti-factor lla activity must be 1.0 ± 0.1. The animals from which the heparin is extracted must fulfil the sanitary requirements of the species in question and the manufacturing process must ensure the elimination or the inactivation of infectious agents. These monograph proposals set standards for the identity, dosage (according to methods Anti-factor Xa activity and Anti-factor IIa activity / ion-exchange high-performance liquid chromatography technique for detection and separation of possible contaminants of the heparin), characteristics, purity assays, biological safety tests, packaging, storing and labeling of the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia.

Products Covered: Pharmacopoeial monographs on the heparin sodium from bovine and porcine in the Brazilian Pharmacopoeia

Regulation Type: Regular notification