Regulatory Updates

Distribution date: 10 July 2014

Products Covered: Matches (HS 3605).

Regulation Type: Addendum to Regular Notification

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

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

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

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

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: 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