Chemical Regulatory Updates – Latest Global Changes

<a name="spsTitle">TITLE:  Psychoactive Substances Act 2013: new legislation to control  psychoactive substances.</a>AGENCY:  Ministry of HealthACTION Enactment of new legislationSUMMARY:  The Ministry of Health has previously notified the TBT Committee of policy decisions about the development of legislation to control unregulated psychoactive substances in New Zealand, in G/TBT/N/NZL/63.  The Psychoactive Substances Act came into force on 17 July 2013.  The Act addresses the problem with the increasing number of unknown, untested and potentially dangerous psychoactive substances.  Under the new legislation, all psychoactive substances are restricted unless a manufacturer can prove they pose no more than a low risk of harm.  Manufacturers are required to provide evidence of the harm profile of products and demonstrate good manufacturing practice.  Any substances meeting the threshold for approval are subject to retail requirements including purchase age, place of sale, advertising and labelling restrictions.The legislation does not apply to alcohol, tobacco, food products such as caffeine, medicines and complementary medicines.The Act provides for a licensing regime for the importation and manufacture of psychoactive substances; establishes a regulator and an expert committee; establishes regulation-making powers for the approval criteria and fees; and provides for offences and penalties for non-compliance.DATES: The Psychoactive Substances Bill was introduced to Parliament on 26 February 2013.  The Bill was considered by the Health Select Committee which reported back to Parliament on 14 June.  The legislation came into force on 17 July 2013.URLs:<a href="http://www.legislation.govt.nz/act/public/2013/0053/latest/DLM5042921.html?search=ts_act%40bill%40regulation%40deemedreg_Psychoactive+Substances+Act+_resel_25_a&p=1">http://www.legislation.govt.nz/act/public/2013/0053/latest/DLM5042921.html?search=ts_act%40bill%40regulation%40deemedreg_Psychoactive+Substances+Act+_resel_25_a&p=1</a><a href="http://www.legislation.govt.nz/bill/government/2013/0100/latest/DLM5042921.html?src=qs">http://www.legislation.govt.nz/bill/government/2013/0100/latest/DLM5042921.html?src=qs</a><a href="http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances">http://www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances</a>

Distribution date: 29 July 2013

Products Covered: 3824.90.99 39L 2921.19.00 39B

Regulation Type: Addendum to Regular Notification

Distribution date: 29 July 2013

Products Covered: 3824.90.99 39L 2921.19.00 39B

Regulation Type: Addendum to Regular Notification

Steel for the reinforcement of concrete: Ribbed bars (4 pages in Hebrew).

Distribution date: 26 July 2013 | Final date for Comment: 24 September 2013

First amendment to the Mandatory Standard SI 4466 part 3. This amendment changes the following:-               Removes from the standard's scope, steel for the reinforcement of concrete classified as S400;-               Adds to the standard's scope, weldable steel for the reinforcement of concrete classified as S500W;-               Adds to the standard's scope, ribbed steel bars produced from finished products, such as plates and railway rails, only if they were re-melted;-               Changes Table 2.1 of paragraph 5 dealing with maximum deviations allowed from nominal values and allows bars with nominal diameter of 12 to 50 mm instead of 12 to 40 mm;-               Replaces figure 3 of paragraph 6 dealing with the requirements for marking the bars according to the type of steel;-               Replaces Table 4 of paragraph 7 dealing with the chemical composition of the bar;-               Replaces Table 6 of paragraph 8.1 dealing with the tensile properties;-               Replaces the last line in paragraph 8.3 dealing with re-bending properties after aging;Removes from Annex A the sample drawing for non-weldable steel.

Products Covered: Ribbed steel bars for the reinforcement of concrete (HS: 7213 and 7214; ICS: 77.140.15 and 91.080.40).

Regulation Type: Regular notification

Steel for the reinforcement of concrete: Ribbed bars (4 pages in Hebrew).

Distribution date: 26 July 2013 | Final date for Comment: 24 September 2013

Products Covered: Ribbed steel bars for the reinforcement of concrete (HS: 7213 and 7214; ICS: 77.140.15 and 91.080.40).

Regulation Type: Regular notification

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 23 July 2013 | Final date for Comment: 21 September 2013

Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticides: Pyraclostrobin Veterinary drug/feed additive: Tylosin

Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.01, 03.02, 03.03, 03.04, 03.05, 03.06 and 03.07) - 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, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05, 12.06, 12.07, 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 23 July 2013 | Final date for Comment: 21 September 2013

Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticides: Pyraclostrobin Veterinary drug/feed additive: Tylosin

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

<pre>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective DateAGENCY: Food and Drug Administration, Health and Human ServicesACTION: Correction SUMMARY: CorrectionIn rule document 2013-15111, appearing on pages 37962-37963 in the issue of Tuesday, 25 June 2013, make the following correction: On page 37962, in the section titled SUPPLEMENTARY INFORMATION, the first paragraph is corrected to read as set forth below: In the Federal Register of 1 April 2013, we amended the color additive regulations in Sec. Sec. 73.3100 and 73.3106 (21 CFR 73.3100 and 73.3106), respectively, to provide for the safe use of additional copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) and additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246), as color additives in contact lenses. We also corrected the nomenclature for Reactive Blue 247 by inserting "2- methyl" before "2-propenoic." </pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/html/C1-2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/pdf/C1-2013-15111.pdf

Distribution date: 19 July 2013

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Corrigendum to Regular Notification

<pre>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective DateAGENCY: Food and Drug Administration, Health and Human ServicesACTION: Correction SUMMARY: CorrectionIn rule document 2013-15111, appearing on pages 37962-37963 in the issue of Tuesday, 25 June 2013, make the following correction: On page 37962, in the section titled SUPPLEMENTARY INFORMATION, the first paragraph is corrected to read as set forth below: In the Federal Register of 1 April 2013, we amended the color additive regulations in Sec. Sec. 73.3100 and 73.3106 (21 CFR 73.3100 and 73.3106), respectively, to provide for the safe use of additional copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) and additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246), as color additives in contact lenses. We also corrected the nomenclature for Reactive Blue 247 by inserting "2- methyl" before "2-propenoic." </pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/html/C1-2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/pdf/C1-2013-15111.pdf

Distribution date: 19 July 2013

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Corrigendum to Regular Notification

<pre>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective DateAGENCY: Food and Drug Administration, Health and Human ServicesACTION: Correction SUMMARY: CorrectionIn rule document 2013-15111, appearing on pages 37962-37963 in the issue of Tuesday, 25 June 2013, make the following correction: On page 37962, in the section titled SUPPLEMENTARY INFORMATION, the first paragraph is corrected to read as set forth below: In the Federal Register of 1 April 2013, we amended the color additive regulations in Sec. Sec. 73.3100 and 73.3106 (21 CFR 73.3100 and 73.3106), respectively, to provide for the safe use of additional copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) and additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246), as color additives in contact lenses. We also corrected the nomenclature for Reactive Blue 247 by inserting "2- methyl" before "2-propenoic." </pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/html/C1-2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/pdf/C1-2013-15111.pdf

Distribution date: 19 July 2013

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Corrigendum to Regular Notification

<pre>TITLE: Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective DateAGENCY: Food and Drug Administration, Health and Human ServicesACTION: Correction SUMMARY: CorrectionIn rule document 2013-15111, appearing on pages 37962-37963 in the issue of Tuesday, 25 June 2013, make the following correction: On page 37962, in the section titled SUPPLEMENTARY INFORMATION, the first paragraph is corrected to read as set forth below: In the Federal Register of 1 April 2013, we amended the color additive regulations in Sec. Sec. 73.3100 and 73.3106 (21 CFR 73.3100 and 73.3106), respectively, to provide for the safe use of additional copolymers of 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247) and additional copolymers of 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone (C.I. Reactive Blue 246), as color additives in contact lenses. We also corrected the nomenclature for Reactive Blue 247 by inserting "2- methyl" before "2-propenoic." </pre> ; ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/html/C1-2013-15111.htm ;http://www.gpo.gov/fdsys/pkg/FR-2013-07-16/pdf/C1-2013-15111.pdf

Distribution date: 19 July 2013

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Corrigendum to Regular Notification

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Steel for the reinforcement of concrete: Ribbed bars (4 pages in Hebrew).

Steel for the reinforcement of concrete: Ribbed bars (4 pages in Hebrew).

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)