Regulatory Updates

Distribution date: 20 November 2015 | Final date for Comment: 19 January 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">Ministry of Health and Labour and Welfare will abolish the Japanese Pharmacopoeia Sixteenth Edition and establish </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">Seven</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">teenth Edition </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">u</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">nder the provision of Article 41 of the act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics.</span></span></span></span></span></span>

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 20 November 2015 | Final date for Comment: 19 January 2016

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">Ministry of Health and Labour and Welfare will abolish the Japanese Pharmacopoeia Sixteenth Edition and establish </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">Seven</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">teenth Edition </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">u</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:'?? ??';mso-fareast-theme-font:minor-fareast;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">nder the provision of Article 41 of the act on securing quality, efficacy and safety of pharmaceuticals, medical devices, regenerative and cellular therapy products, gene therapy products, and cosmetics.</span></span></span></span></span></span>

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 20 November 2015 | Final date for Comment: 19 January 2016

This standard applies to food additive sodium carboxymethyl cellulose, which is made from cellulose, sodium hydroxide and chloroacetic acid or its sodium salt as raw material. It stipulates the technical requirements and test methods for sodium carboxymethyl cellulose.

Products Covered: Food additive Sodium carboxymethyl cellulose

Regulation Type: Regular notification

Distribution date: 20 November 2015 | Final date for Comment: 19 January 2016

This standard applies to food additive sodium carboxymethyl cellulose, which is made from cellulose, sodium hydroxide and chloroacetic acid or its sodium salt as raw material. It stipulates the technical requirements and test methods for sodium carboxymethyl cellulose.

Products Covered: Food additive Sodium carboxymethyl cellulose

Regulation Type: Regular notification

Distribution date: 19 November 2015 | Final date for Comment: 18 January 2016

This standard applies to food additive Citric acid, which uses starch or sugar as raw materials, and is obtained through fermentation. It stipulates the technical requirements and test methods for Citric acid.

Products Covered: Food additive Citric acid

Regulation Type: Regular notification

Distribution date: 19 November 2015 | Final date for Comment: 18 January 2016

This standard applies to food additive Citric acid, which uses starch or sugar as raw materials, and is obtained through fermentation. It stipulates the technical requirements and test methods for Citric acid.

Products Covered: Food additive Citric acid

Regulation Type: Regular notification

Distribution date: 19 November 2015 | Final date for Comment: 18 January 2016

This standard applies to food additive carbon dioxide, which uses carbon dioxide produced by alcohol fermentation, calcination of carbonates, synthesis ammonia, ethylene catalytic oxidation, gasification and other process as raw material, and is obtained through purification, refining, drying, cooling and pressing process. It stipulates technical requirements and test methods.

Products Covered: Food additive Carbon dioxide

Regulation Type: Regular notification

Distribution date: 19 November 2015 | Final date for Comment: 18 January 2016

This standard applies to food additive carbon dioxide, which uses carbon dioxide produced by alcohol fermentation, calcination of carbonates, synthesis ammonia, ethylene catalytic oxidation, gasification and other process as raw material, and is obtained through purification, refining, drying, cooling and pressing process. It stipulates technical requirements and test methods.

Products Covered: Food additive Carbon dioxide

Regulation Type: Regular notification

Distribution date: 13 November 2015 | Final date for Comment: 12 January 2016

<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This notification is the 3^rd revision of G/TBT/N/MYS/15, notified on 6 November 2008. The 1^st and 2^nd revisions were notified on 19 October 2010 and 12 March 2014 respectively. </span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>This revision is due to changes that occurred in revision of the standards in line with suggestions and proposals from the toys industry players as well as to further strengthen the regulations. </span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>The major amendments to the regulations are as the following: </span></span></span></p><p style="margin:6pt 0cm 6pt 29.45pt;text-indent:-1cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span></p>a.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The removal of column "Year" in Schedule 1 of P.U. (A) 275<br />b.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The removal of Malaysian Standard 1174 Part 6 as one of the prescribed safety standards<br />c.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The addition of 13 international toys safety standards<br />d.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; New enforcement date<br />e.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Minor amendments to Schedule 2 of P.U. (A) 275 are made<br />f.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Inclusion of the requirement of compliance to toys supplied as gift, free items or free offer<br />g.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The requirement for maintenance of records by the product owners within a specified time<br />h.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The requirement for products owners to notify the Ministry on non-compliance issues and corrective actions taken within a specified time<br />i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The addition of retailer as the product owner and<br />j.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Amendments to P.U. (A) 253 to facilitate enforcement activities are made

Products Covered: Toys (HS: Chapter 95, 87, 36) (ICS: 97.200.50) . Toys means any goods designed or intended for use in play by children less than fourteen years of age but does not include the goods specified in the Second Schedule of P.U. (A) 275. ; ; HS Code for toys: ; (1) HS 9503.00 - Tricycles, scooters, pedal cars and similar wheeled toys; dolls carriages; dolls: others toys; reduced size ('scale’) models and similar recreational models, working or not (operated at a nominal voltage of 24V and below); puzzles of all kinds (500 pieces and below) ; (2) HS 9503.00 100 - Tricycles ; (3) HS 9503.00 200 - Others wheeled toys; dolls carriages ; (4) HS 9503.00 300 - Dolls including parts and accessories ; (5) HS 9503.00 400 - Reduced-size ('scale') models and similar recreational models, working or not (operated at a nominal voltage of 24V and below); puzzles of all kinds (500 pieces and below) ; (6) HS 9503.00 920 - Of rubber ; (7) HS 9503.00 990 - Other toys ; (8) HS 9504.40 000 - Playing cards for children ; (9) HS 9504.90 200 - Video games of a kind used with a television receiver (operated at a nominal voltage of 24V and below) ; (10) HS 8712.00 120 - Bicycles, designed to be ridden by children (not in the form of adults' cycles) (saddle height of 435mm and below) ; (11) HS 3604.90 200 - Percussion caps for toys ;

Regulation Type: Revision to Regular Notification

Distribution date: 13 November 2015 | Final date for Comment: 12 January 2016

<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">This notification is the 3^rd revision of G/TBT/N/MYS/15, notified on 6 November 2008. The 1^st and 2^nd revisions were notified on 19 October 2010 and 12 March 2014 respectively. </span></span></p><p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>This revision is due to changes that occurred in revision of the standards in line with suggestions and proposals from the toys industry players as well as to further strengthen the regulations. </span></span></span></p><p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>The major amendments to the regulations are as the following: </span></span></span></p><p style="margin:6pt 0cm 6pt 29.45pt;text-indent:-1cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span></span></span></span></p>a.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The removal of column "Year" in Schedule 1 of P.U. (A) 275<br />b.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The removal of Malaysian Standard 1174 Part 6 as one of the prescribed safety standards<br />c.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The addition of 13 international toys safety standards<br />d.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; New enforcement date<br />e.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Minor amendments to Schedule 2 of P.U. (A) 275 are made<br />f.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Inclusion of the requirement of compliance to toys supplied as gift, free items or free offer<br />g.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The requirement for maintenance of records by the product owners within a specified time<br />h.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The requirement for products owners to notify the Ministry on non-compliance issues and corrective actions taken within a specified time<br />i.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The addition of retailer as the product owner and<br />j.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Amendments to P.U. (A) 253 to facilitate enforcement activities are made

Products Covered: Toys (HS: Chapter 95, 87, 36) (ICS: 97.200.50) . Toys means any goods designed or intended for use in play by children less than fourteen years of age but does not include the goods specified in the Second Schedule of P.U. (A) 275. ; ; HS Code for toys: ; (1) HS 9503.00 - Tricycles, scooters, pedal cars and similar wheeled toys; dolls carriages; dolls: others toys; reduced size ('scale’) models and similar recreational models, working or not (operated at a nominal voltage of 24V and below); puzzles of all kinds (500 pieces and below) ; (2) HS 9503.00 100 - Tricycles ; (3) HS 9503.00 200 - Others wheeled toys; dolls carriages ; (4) HS 9503.00 300 - Dolls including parts and accessories ; (5) HS 9503.00 400 - Reduced-size ('scale') models and similar recreational models, working or not (operated at a nominal voltage of 24V and below); puzzles of all kinds (500 pieces and below) ; (6) HS 9503.00 920 - Of rubber ; (7) HS 9503.00 990 - Other toys ; (8) HS 9504.40 000 - Playing cards for children ; (9) HS 9504.90 200 - Video games of a kind used with a television receiver (operated at a nominal voltage of 24V and below) ; (10) HS 8712.00 120 - Bicycles, designed to be ridden by children (not in the form of adults' cycles) (saddle height of 435mm and below) ; (11) HS 3604.90 200 - Percussion caps for toys ;

Regulation Type: Revision to Regular Notification