Regulatory Updates

Distribution date: 03 December 2012 | Final date for Comment: 01 February 2013

El proyecto de Decreto Supremo contiene 4 Artículos. ; El Artículo 1º del proyecto modifica los Artículos 28º, 69º, 73º, 90º y 110º del Reglamento de Establecimientos Farmacéuticos aprobado por Decreto Supremo Nº 014-2011-SA. ; El Artículo 2º del proyecto modifica las infracciones 9, 12, 13, 14, 15, 16, 28, 36, 48, 61, 66, 67, 68 y 69 del Anexo 01: Escala por Infracciones y Sanciones a los Establecimientos Farmacéuticos, del citado Reglamento. ; Los Artículos 3º y 4º del proyecto están referidos a su refrendo y vigencia. ;

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs, and other products and preparations, e.g. dressings and mordants of a kind used in the textile or similar industries, n.e.s. (excl. those with a basis of amylaceous substances) (HS code(s): 380991); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Distribution date: 03 December 2012 | Final date for Comment: 01 February 2013

El proyecto de Decreto Supremo contiene 4 Artículos. ; El Artículo 1º del proyecto modifica los Artículos 28º, 69º, 73º, 90º y 110º del Reglamento de Establecimientos Farmacéuticos aprobado por Decreto Supremo Nº 014-2011-SA. ; El Artículo 2º del proyecto modifica las infracciones 9, 12, 13, 14, 15, 16, 28, 36, 48, 61, 66, 67, 68 y 69 del Anexo 01: Escala por Infracciones y Sanciones a los Establecimientos Farmacéuticos, del citado Reglamento. ; Los Artículos 3º y 4º del proyecto están referidos a su refrendo y vigencia. ;

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30); Perfumes and toilet waters (excl. aftershave lotions, personal deodorants and hair lotions) (HS code(s): 3303); Beauty or make-up preparations and preparations for the care of the skin, incl. sunscreen or sun tan preparations (excl. medicaments); manicure or pedicure preparations (HS code(s): 3304); Preparations for use on the hair (HS code(s): 3305); Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Finishing agents, dye carriers to accelerate the dyeing or fixing of dyestuffs, and other products and preparations, e.g. dressings and mordants of a kind used in the textile or similar industries, n.e.s. (excl. those with a basis of amylaceous substances) (HS code(s): 380991); Toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width

Regulation Type: Regular notification

Distribution date: 03 December 2012 | Final date for Comment: 01 February 2013

This draft notification prescribes as follows: Clause 1. The Notification of the Ministry of Public Health No. 262 B.E. 2545 (2002), Re: Stevioside and Foods Containing Stevioside, dated 26 September B.E. 2545 (2002), shall be repealed; Clause 2. Steviol glycosides are food additive; Clause 3. Steviol glycosides are purified extracts of Stevia rebaudiana Bertoni. Associated glycosides include rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside F, dulcoside A, rubusoside and steviolbioside; Clause 4. Producers or importers of food for sale shall follow to the notification of the Ministry of Public Health No. 281 B.E. 2547 (2004), dated 6 September B.E. 2547 (2004), Re: Food Additives, except for Clause 4 and 6 shall follow to Clause 5 and 6 of this draft MOPH notification; Clause 5 to 6. Food items under clause 3 in this draft notification shall comply to the following qualities and standards: (1) Qualities or standards, i.e. Chemical name, Chemical formula, Description, Identification, Purity, Packaging and Storage; (2) The types of food and quantities of Steviol glycosides shall be complied with the Annex of this notification. Clause 7. Producers or importers of the food as stipulated in clause 3, whose food serial number permitted under the Notification of the Ministry of Public Health No. 262 B.E. 2545 (2002), Re: Stevioside and Foods Containing Stevioside, dated 26 September B.E. 2545 (2002) prior to this draft notification come into force, shall follow this draft notification and the notification of the Ministry of Public Health No. 281 B.E. 2547 (2004), dated 18 November B.E. 2547 (2004) within one year after this draft notification come into force; Foods Containing stevioside for person who wishes to control weight under the notification of the Ministry of Public Health No. 121 B.E. 2532 (1989), Re: weight control food, shall follow this draft notification within one year after this draft notification come into force; Clause 8. This draft notification is effective on the day after its announcement in the Government Gazette.

Products Covered: Food Additives (No.4): Steviol glycoside (ICS Code: 67.220)

Regulation Type: Regular notification

Distribution date: 03 December 2012 | Final date for Comment: 01 February 2013

This draft notification prescribes as follows: Clause 1. The Notification of the Ministry of Public Health No. 262 B.E. 2545 (2002), Re: Stevioside and Foods Containing Stevioside, dated 26 September B.E. 2545 (2002), shall be repealed; Clause 2. Steviol glycosides are food additive; Clause 3. Steviol glycosides are purified extracts of Stevia rebaudiana Bertoni. Associated glycosides include rebaudioside B, rebaudioside C, rebaudioside D, rebaudioside F, dulcoside A, rubusoside and steviolbioside; Clause 4. Producers or importers of food for sale shall follow to the notification of the Ministry of Public Health No. 281 B.E. 2547 (2004), dated 6 September B.E. 2547 (2004), Re: Food Additives, except for Clause 4 and 6 shall follow to Clause 5 and 6 of this draft MOPH notification; Clause 5 to 6. Food items under clause 3 in this draft notification shall comply to the following qualities and standards: (1) Qualities or standards, i.e. Chemical name, Chemical formula, Description, Identification, Purity, Packaging and Storage; (2) The types of food and quantities of Steviol glycosides shall be complied with the Annex of this notification. Clause 7. Producers or importers of the food as stipulated in clause 3, whose food serial number permitted under the Notification of the Ministry of Public Health No. 262 B.E. 2545 (2002), Re: Stevioside and Foods Containing Stevioside, dated 26 September B.E. 2545 (2002) prior to this draft notification come into force, shall follow this draft notification and the notification of the Ministry of Public Health No. 281 B.E. 2547 (2004), dated 18 November B.E. 2547 (2004) within one year after this draft notification come into force; Foods Containing stevioside for person who wishes to control weight under the notification of the Ministry of Public Health No. 121 B.E. 2532 (1989), Re: weight control food, shall follow this draft notification within one year after this draft notification come into force; Clause 8. This draft notification is effective on the day after its announcement in the Government Gazette.

Products Covered: Food Additives (No.4): Steviol glycoside (ICS Code: 67.220)

Regulation Type: Regular notification

Distribution date: 26 November 2012

Proposed standards for use of vertebral column derived from cattle raised in countries or regions with the occurrence of bovine spongiform encephalopathy (BSE) for manufacturing, processing or preparing foods.

Products Covered: Meat and edible meat offal of bovine animals (HS Codes: 02.01, 02.02, 02.06 and 02.10) Bones unworked, defatted, simply prepared (but not cut to shape), treated with acid or degelatinised; powder and waste of these products (HS Code: 05.06) Fats of bovine animals (HS Codes:15.02 and 15.03) Other prepared or preserved meat or meat offal of bovine animals (HS Codes: 16.02 and 16.03) Greaves of bovine animals (HS Code: 23.01) Gelatin of bovine animals (HS Code: 35.03)

Regulation Type: Regular notification

Distribution date: 26 November 2012

Proposed standards for use of vertebral column derived from cattle raised in countries or regions with the occurrence of bovine spongiform encephalopathy (BSE) for manufacturing, processing or preparing foods.

Products Covered: Meat and edible meat offal of bovine animals (HS Codes: 02.01, 02.02, 02.06 and 02.10) Bones unworked, defatted, simply prepared (but not cut to shape), treated with acid or degelatinised; powder and waste of these products (HS Code: 05.06) Fats of bovine animals (HS Codes:15.02 and 15.03) Other prepared or preserved meat or meat offal of bovine animals (HS Codes: 16.02 and 16.03) Greaves of bovine animals (HS Code: 23.01) Gelatin of bovine animals (HS Code: 35.03)

Regulation Type: Regular notification

Distribution date: 23 November 2012 | Final date for Comment: 22 January 2013

Specifies the requirements and prescribes the methods of test for Monoammonium phosphate (MAP) and Diammonium phosphate (DAP), technical grades of fertilizers

Products Covered: Fertilizers (HS: 310221; ICS: 65.080).

Regulation Type: Regular notification

Distribution date: 23 November 2012 | Final date for Comment: 22 January 2013

Specifies the requirements and prescribes the methods of test for Monoammonium phosphate (MAP) and Diammonium phosphate (DAP), technical grades of fertilizers

Products Covered: Fertilizers (HS: 310221; ICS: 65.080).

Regulation Type: Regular notification

Distribution date: 23 November 2012 | Final date for Comment: 22 January 2013

Specifies the requirements, methods of sampling and tests for Potassium sulphate fertilizer, technical grade.

Products Covered: Fertilizers (HS: 310430; ICS: 65.080).

Regulation Type: Regular notification

Distribution date: 23 November 2012 | Final date for Comment: 22 January 2013

Specifies the requirements, methods of sampling and tests for Potassium sulphate fertilizer, technical grade.

Products Covered: Fertilizers (HS: 310430; ICS: 65.080).

Regulation Type: Regular notification