Regulatory Updates

Proposed amendments to the regulation of Food and Drugs Testing Laboratories Assessment

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Distribution date: 12 March 2015 | Final date for Comment: 14 April 2015

a. Amend Annex 4. LAQAS (Laboratory Quality Assurance Standards) of the regulation of Food and Drugs Testing Laboratories Assessment to install testing record management system (such as Audit trail for instruments, using laboratory notebook for manual testing, etc). b. Amend the Certificate of Laboratory Testing to minimize fraud possibility. c. Establish requirements of re-operating laboratory after service suspension due to testing ability.

Products Covered: Testing laboratories (food, livestock product, drug, traditional Korean medicinal substance, medical device, cosmetics)

Regulation Type: Regular notification

Human health Food safety Certification, control and inspection

Draft Notification of the Committee on Labels No. … (B.E. …): Lead-Containing Paints Required Labelling Control (1 page, in Thai)

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Distribution date: 11 March 2015 | Final date for Comment: 10 May 2015

<p style="margin:6pt 0cm;text-align:justify;text-justify:inter-cluster;"><span style="font-size:x-small;font-face:Verdana;"><span style="font-size:9pt;"><span>The Office of the Consumer Protection Board (OCPB) </span>has proposed draft Notification of the Committee on Labels No. </span></span><span>…</span><span> (B.E. …): Lead-Containing Paints Required Labelling Control, including definition of paints</span>, label contents and font sizes as follows:</p><ul><li><span><span style="font-face:Times New Roman;">"</span>Paints" mean paint used for exterior or interior of a house or a building</span></li><li><span>Lead-containing paints required labelling control must <span>&nbsp;</span>comply with Clause 1 to </span><span lang="EN-US">Clause</span><span lang="EN-US"> </span><span>3 of the Notification of the Committee on Labels: Characteristics of Labels Subject to the Labelling Control B.E.</span><span style="font-size:small;font-face:Cordia New;"><span lang="TH" style="font-family:'Cordia New','sans-serif';font-size:11pt;"></span></span><span>2541(1998) dated 23 September B.E. 2541(1998), a</span>nd the label must contain the following information:</li></ul><ol start="1" style="margin-left:30px;"><li><span style="background:white;">The<span>&nbsp;</span><span style="font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';">quantity of lead in paints</span></span></span><span> in part per million (ppm)</span></li><li><span>If the quantity of lead is more than 100 ppm, following warning shall be displayed "Lead may harm human brain and </span><span style="background:white;">erythrocyte</span><span>, prohibited from painting house or building"</span></li></ol><ul><li><span style="font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';font-size:9pt;">The font must use bold red colour, the size shall not be less than 5 mm with white background and </span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">at </span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">noticeable </span><span style="font-size:x-small;"><span lang="EN-US" style="font-size:9pt;">position</span><span style="font-size:x-small;"><span style="font-size:9pt;">.</span></span></span></span></span></span><span></span></li></ul><p style="text-align:justify;text-indent:-21.3pt;margin-left:37.15pt;text-justify:inter-cluster;tab-stops:37.15pt;"><span style="font-size:x-small;font-face:Verdana;"></span></p>

Products Covered: Lead-containing paints (HS: 3208, 3209; ICS: 87.040)

Regulation Type: Regular notification

Notification of the Ministry of Industry No. … (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Deformed Bars (Amendment No. 1) (3 pages, in Thai)

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Distribution date: 09 March 2015 | Final date for Comment: 08 May 2015

<span style="font-size:x-small;font-face:Verdana;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The Thai Industrial Standards Institute (TISI) has proposed to amend the Thai Industrial Standard for </span><span style="font-size:x-small;"><span style="background:white;font-size:9pt;">Steel Bars for Reinforced Concrete: Deformed Bars (TIS 24-2548(2005))</span><span style="font-size:x-small;"><span style="letter-spacing:-0.1pt;font-size:9pt;">.<span>&nbsp; </span>The main amendment includes chemical composition (ladle analysis) and tolerances and marking.</span></span></span></span>

Products Covered: Steel bars (HS:7214, ICS: 77.140.60)

Regulation Type: Regular notification

Notification of the Ministry of Industry No. … (B.E. 25xx) Issued under the Industrial Product Standards Act B.E. 2511(1968): Amending to Thai Industrial Standard for Steel Bars for Reinforced Concrete: Round Bar (Amendment No. 1) (3 pages, in Thai)

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Distribution date: 09 March 2015 | Final date for Comment: 08 May 2015

<span style="font-size:x-small;font-face:Verdana;"><span style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;">The Thai Industrial Standards Institute (TISI) has proposed to amend the Thai Industrial Standard for </span><span style="font-size:x-small;"><span style="background:white;font-size:9pt;">Steel Bars for Reinforced Concrete: Round Bar (TIS 20-2543(2000))</span><span style="font-size:x-small;"><span style="letter-spacing:-0.1pt;font-size:9pt;">.<span>&nbsp;</span>The main amendment includes chemical composition (ladle analysis) and tolerances, marking and sampling plan.</span></span></span></span>

Products Covered: Steel bars (HS:7214, ICS: 77.140.60)

Regulation Type: Regular notification

PROY-NOM-073-SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios (21 páginas, en español)

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Distribution date: 27 February 2015

La norma notificada es de observancia obligatoria para: las fábricas o laboratorios de materias primas para la elaboración de medicamentos o productos biológicos, para uso humano y fábricas o laboratorios de medicamentos o productos biológicos para uso humano o fábricas o laboratorios de remedios herbolarios, que producen fármacos, medicamentos, así como remedios herbolarios, que se comercialicen en los Estados Unidos Mexicanos.

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)

Regulation Type: Regular notification

Human health

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

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Distribution date: 27 February 2015 | Final date for Comment: 28 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Malathion

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04 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, 10.06, 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) - Cacao and cacao preparations (HS Code: 18.01)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

1. Regulation of the Minister of Agriculture No. 139/Permentan/PD.410/12/2014 concerning Importation of Carcass, Meat and/or Processed Meat Products Into the Territory of the Republic of Indonesia (32 pages, in Indonesian language) ; 2. Regulation of the Minister of Agriculture No. 02/Permentan/PD.410/01/2015 concerning the Amendment of Regulation of Minister of Agriculture No. 139/Permentan/PD.410/12/201 (5 pages, in Indonesian language)

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Distribution date: 17 February 2015 | Final date for Comment: 18 April 2015

<p style="margin:6pt 0in;">The Regulation of Minister of Agriculture covers the requirements and procedures for importation and its supervision of carcass, meat and/or processed meat products; This amendment is necessary in order to meet the food supply, price volatility and/or emergencies condition.</p><p style="margin:6pt 0in;"><span><span lang="IN"></span></span></p>

Products Covered: Meat of Bovine HS: Ex 02.01.20.00.00; ex 02.01.30.00.00; ex 02.02.20.00.00; ex 02.02.30.00.00; 02.06.10.00.00; ex 02.06.21.00.00; ex 02.06.29.00.00 ; Carcass and/or Meat of non bovine, and processed Meat HS: 02.03.11.00.00; 02.03.12.00.00; 02.03.19.00.00; 02.03.21.00.00; 02.03.22.00.00; 02.03.29.00.00; 02.04.10.00.00; 02.04.21.00.00; 02.04.22.00.00; 02.04.23.00.00; 02.04.30.00.00; 02.04.41.00.00; ; 02.04.42.00.00; 02.04.43.00.00; ex 02.04.50.00.00; ex 02.07.11.00.00; Ex 02.07.12.00.00; ex 02.07.24.00.00; ex 02.07.25.00.00; ex 02.07.41.00.00; Ex 02.07.42.00.00; ex 02.08.90.90.00 ; Processed Meat HS: Ex 16.01.00.10.00; Ex 16.01.00.90.00; Ex 16.02.10.10.00; Ex 16.02.10.90.00; Ex 16.02.20.00.00; 16.02.41.10.00; 16.02.41.90.00; 16.02.42.10.00; 16.02.42.90.00; 16.02.49.11.00; 16.02.49.19.00; 16.02.49.91.00; 16.02.49.99.00; 16.02.50.00.00; 16.02.90.10.00; Ex 16.02.90.90.00.

Regulation Type: Regular notification

Food standards

1. Regulation of the Minister of Agriculture No. 139/Permentan/PD.410/12/2014 concerning Importation of Carcass, Meat and/or Processed Meat Products Into the Territory of the Republic of Indonesia (32 pages, in Indonesian language) ; 2. Regulation of the Minister of Agriculture No. 02/Permentan/PD.410/01/2015 concerning the Amendment of Regulation of Minister of Agriculture No. 139/Permentan/PD.410/12/201 (5 pages, in Indonesian language)

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Distribution date: 17 February 2015 | Final date for Comment: 18 April 2015

<p style="margin:6pt 0in;">The Regulation of Minister of Agriculture covers the requirements and procedures for importation and its supervision of carcass, meat and/or processed meat products; This amendment is necessary in order to meet the food supply, price volatility and/or emergencies condition.</p><p style="margin:6pt 0in;"><span><span lang="IN"></span></span></p>

Products Covered: Meat of Bovine HS: Ex 02.01.20.00.00; ex 02.01.30.00.00; ex 02.02.20.00.00; ex 02.02.30.00.00; 02.06.10.00.00; ex 02.06.21.00.00; ex 02.06.29.00.00 ; Carcass and/or Meat of non bovine, and processed Meat HS: 02.03.11.00.00; 02.03.12.00.00; 02.03.19.00.00; 02.03.21.00.00; 02.03.22.00.00; 02.03.29.00.00; 02.04.10.00.00; 02.04.21.00.00; 02.04.22.00.00; 02.04.23.00.00; 02.04.30.00.00; 02.04.41.00.00; ; 02.04.42.00.00; 02.04.43.00.00; ex 02.04.50.00.00; ex 02.07.11.00.00; Ex 02.07.12.00.00; ex 02.07.24.00.00; ex 02.07.25.00.00; ex 02.07.41.00.00; Ex 02.07.42.00.00; ex 02.08.90.90.00 ; Processed Meat HS: Ex 16.01.00.10.00; Ex 16.01.00.90.00; Ex 16.02.10.10.00; Ex 16.02.10.90.00; Ex 16.02.20.00.00; 16.02.41.10.00; 16.02.41.90.00; 16.02.42.10.00; 16.02.42.90.00; 16.02.49.11.00; 16.02.49.19.00; 16.02.49.91.00; 16.02.49.99.00; 16.02.50.00.00; 16.02.90.10.00; Ex 16.02.90.90.00.

Regulation Type: Regular notification

Food standards

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of Agricultural Chemical Residue Standards).

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Distribution date: 03 February 2015 | Final date for Comment: 04 April 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide - Dichlobenil

Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.09 and 07.10) - 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: 09.04, 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, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.04, 12.05, 12.06 and 12.07)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Raw Materials (Ingredients) List #1 of Detergent Used for Food

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Distribution date: 12 February 2015 | Final date for Comment: 13 April 2015

The document is used for regulating the administration of raw materials of detergent used for food (including fruits, vegetables, raw materials of food products, food semi-finished products, etc.), tableware and food industrial equipment.

Products Covered: Detergent used for food

Regulation Type: Regular notification

Food safety Human health Contaminants

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