Statutory Instrument No.98 of 2019

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Distribution date: 23 September 2019 | Final date for Comment: 01 November 2019

The procedure for pattern or type approval of measuring instruments, as given in the Metrology Act Chapter 13.18,  has been amended.

Products Covered: Measuring instruments subject to pattern or type approval under Saint Lucia’s Metrology Act Chapter 13.18. 8413.11 Fuel dispensers 8413.91 Other 8423.20 Scales for continuous weighing of goods on conveyors 8423.30 Constant weight scales and scales for discharging a predetermined weight of material into a bag or container, including hopper scales 8423.81 Having a maximum weighing capacity not exceeding 30 kg 8423.82 Having a maximum weighing capacity exceeding 30 kg but not exceeding 5,000 kg 8423.89 Other 8423.90 Weighing machine weights of all kinds; parts of weighing machinery 9016.00 Balances of a sensitivity of 5 cg or better, with or without weights. 9017.80 Other instruments 9018.90 Blood pressure monitors 9024.80 Other machines and appliances 9025.11 Liquid-filled, for direct reading 9025.19 Other 9026.20 For measuring or checking pressure 9027.80 Breathalyzers 9028.10 Gas meters 9028.20 Water meters 9028.30 Electrical energy meters 9031.80 Other instruments

Regulation Type: Regular notification

Metrology

Draft resolution number 710, September 16th, 2019.

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Distribution date: 24 September 2019 | Final date for Comment: 08 November 2019

This draft resolution proposes the revision of the Resolution – RDC number 4, 4 February 2011, which establishes the minimum requirements of identity and quality for transfusion, infusion and transfusion pumps sets for single use. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=50302

Products Covered: HS Code(s): 30045020 (infusion sets for single use)

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Andino sobre Especificaciones Técnicas Microbiológicas de Productos Cosméticos (Draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics) (5 pages, in Spanish)

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Distribution date: 24 September 2019 | Final date for Comment: 16 November 2019

The notified draft Andean Technical Regulation establishes the microbiological technical specifications and, where applicable, the physicochemical specifications for cosmetics, on the basis of which such products are deemed to be free from microbiological contamination. It applies to the cosmetics specified on the indicative list contained in Andean Community Decision No. 833.

Products Covered: 3303.00.00 Perfumes and toilet waters; 33.04 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations; 3304.10.00 Lip make-up preparations; 3304.20.00 Eye make-up preparations; 3304.30 Manicure or pedicure preparations - Other; 3304.91.00 Powders, whether or not compressed; 3304.99.00 Other; 33.05 Preparations for use on the hair; 3305.10.00 Shampoos; 3305.20.00 Preparations for permanent waving or straightening; 3305.30.00 Hair lacquers; 3305.90.00 Other; 33.06 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in individual retail packages; 3306.10.00 Dentifrices; 3306.90.00 Other; 33.07 Pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories and other perfumery, cosmetic or toilet preparations, not elsewhere specified or included; prepared room deodorisers, whether or not perfumed or having disinfectant properties; 3307.10.00 Pre-shave, shaving or after-shave preparations; 3307.20.00 Personal deodorants and antiperspirants; 3307.30.00 Perfumed bath salts and other bath preparations; 3307.90 Other; 3307.90.90 Other; 34.01 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 - - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent; 3401.11.00 For toilet use (including medicated products); 3401.20.00 Soap in other forms; 3401.30.00 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; 38.08 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers). Other; 3808.91 Insecticides; 3808.91.14 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.19 Other; 3808.91.91 Containing natural pyrethrum (pyrethrins); 3808.91.97 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.99 Other; Perfumes and toilet waters (HS 3303); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations (HS 3304); Preparations for use on the hair (HS 3305); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790); For toilet use (including medicated products) (HS 340111); Soap in other forms (HS 340120); 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 (HS 340130)

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Andino sobre Especificaciones Técnicas Microbiológicas de Productos Cosméticos (Draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics) (5 pages, in Spanish)

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Distribution date: 24 September 2019 | Final date for Comment: 16 November 2019

The notified draft Andean Technical Regulation establishes the microbiological technical specifications and, where applicable, the physicochemical specifications for cosmetics, on the basis of which such products are deemed to be free from microbiological contamination. It applies to the cosmetics specified on the indicative list contained in Andean Community Decision No. 833.

Products Covered: 3303.00.00 Perfumes and toilet waters; 33.04 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations; 3304.10.00 Lip make-up preparations; 3304.20.00 Eye make-up preparations; 3304.30 Manicure or pedicure preparations - Other; 3304.91.00 Powders, whether or not compressed; 3304.99.00 Other; 33.05 Preparations for use on the hair; 3305.10.00 Shampoos; 3305.20.00 Preparations for permanent waving or straightening; 3305.30.00 Hair lacquers; 3305.90.00 Other; 33.06 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in individual retail packages; 3306.10.00 Dentifrices; 3306.90.00 Other; 33.07 Pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories and other perfumery, cosmetic or toilet preparations, not elsewhere specified or included; prepared room deodorisers, whether or not perfumed or having disinfectant properties; 3307.10.00 Pre-shave, shaving or after-shave preparations; 3307.20.00 Personal deodorants and antiperspirants; 3307.30.00 Perfumed bath salts and other bath preparations; 3307.90 Other; 3307.90.90 Other; 34.01 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 - - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent; 3401.11.00 For toilet use (including medicated products); 3401.20.00 Soap in other forms; 3401.30.00 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; 38.08 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers). Other; 3808.91 Insecticides; 3808.91.14 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.19 Other; 3808.91.91 Containing natural pyrethrum (pyrethrins); 3808.91.97 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.99 Other; Perfumes and toilet waters (HS 3303); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations (HS 3304); Preparations for use on the hair (HS 3305); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790); For toilet use (including medicated products) (HS 340111); Soap in other forms (HS 340120); 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 (HS 340130)

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Andino sobre Especificaciones Técnicas Microbiológicas de Productos Cosméticos (Draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics) (5 pages, in Spanish)

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Distribution date: 24 September 2019 | Final date for Comment: 16 November 2019

The notified draft Andean Technical Regulation establishes the microbiological technical specifications and, where applicable, the physicochemical specifications for cosmetics, on the basis of which such products are deemed to be free from microbiological contamination. It applies to the cosmetics specified on the indicative list contained in Andean Community Decision No. 833.

Products Covered: 3303.00.00 Perfumes and toilet waters; 33.04 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations; 3304.10.00 Lip make-up preparations; 3304.20.00 Eye make-up preparations; 3304.30 Manicure or pedicure preparations - Other; 3304.91.00 Powders, whether or not compressed; 3304.99.00 Other; 33.05 Preparations for use on the hair; 3305.10.00 Shampoos; 3305.20.00 Preparations for permanent waving or straightening; 3305.30.00 Hair lacquers; 3305.90.00 Other; 33.06 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in individual retail packages; 3306.10.00 Dentifrices; 3306.90.00 Other; 33.07 Pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories and other perfumery, cosmetic or toilet preparations, not elsewhere specified or included; prepared room deodorisers, whether or not perfumed or having disinfectant properties; 3307.10.00 Pre-shave, shaving or after-shave preparations; 3307.20.00 Personal deodorants and antiperspirants; 3307.30.00 Perfumed bath salts and other bath preparations; 3307.90 Other; 3307.90.90 Other; 34.01 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 - - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent; 3401.11.00 For toilet use (including medicated products); 3401.20.00 Soap in other forms; 3401.30.00 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; 38.08 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers). Other; 3808.91 Insecticides; 3808.91.14 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.19 Other; 3808.91.91 Containing natural pyrethrum (pyrethrins); 3808.91.97 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.99 Other; Perfumes and toilet waters (HS 3303); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations (HS 3304); Preparations for use on the hair (HS 3305); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790); For toilet use (including medicated products) (HS 340111); Soap in other forms (HS 340120); 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 (HS 340130)

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Andino sobre Especificaciones Técnicas Microbiológicas de Productos Cosméticos (Draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics) (5 pages, in Spanish)

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Distribution date: 24 September 2019 | Final date for Comment: 16 November 2019

The notified draft Andean Technical Regulation establishes the microbiological technical specifications and, where applicable, the physicochemical specifications for cosmetics, on the basis of which such products are deemed to be free from microbiological contamination. It applies to the cosmetics specified on the indicative list contained in Andean Community Decision No. 833.

Products Covered: 3303.00.00 Perfumes and toilet waters; 33.04 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations; 3304.10.00 Lip make-up preparations; 3304.20.00 Eye make-up preparations; 3304.30 Manicure or pedicure preparations - Other; 3304.91.00 Powders, whether or not compressed; 3304.99.00 Other; 33.05 Preparations for use on the hair; 3305.10.00 Shampoos; 3305.20.00 Preparations for permanent waving or straightening; 3305.30.00 Hair lacquers; 3305.90.00 Other; 33.06 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in individual retail packages; 3306.10.00 Dentifrices; 3306.90.00 Other; 33.07 Pre-shave, shaving or after-shave preparations, personal deodorants, bath preparations, depilatories and other perfumery, cosmetic or toilet preparations, not elsewhere specified or included; prepared room deodorisers, whether or not perfumed or having disinfectant properties; 3307.10.00 Pre-shave, shaving or after-shave preparations; 3307.20.00 Personal deodorants and antiperspirants; 3307.30.00 Perfumed bath salts and other bath preparations; 3307.90 Other; 3307.90.90 Other; 34.01 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 - - Soap and organic surface-active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent; 3401.11.00 For toilet use (including medicated products); 3401.20.00 Soap in other forms; 3401.30.00 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; 38.08 Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, and fly-papers). Other; 3808.91 Insecticides; 3808.91.14 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.19 Other; 3808.91.91 Containing natural pyrethrum (pyrethrins); 3808.91.97 Containing permethrin or cypermethrin or other synthetic substitutes for pyrethrum (pyrethroids), with the exception of those specified in Subheading Note 2 to this Chapter; 3808.91.99 Other; Perfumes and toilet waters (HS 3303); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan preparations; manicure or pedicure preparations (HS 3304); Preparations for use on the hair (HS 3305); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790); For toilet use (including medicated products) (HS 340111); Soap in other forms (HS 340120); 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 (HS 340130)

Regulation Type: Regular notification

Draft resolution number 717, 16 September 2019, regarding the active ingredient E22 - EPOXICONAZOL (epoxiconazole) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient E22 - EPOXICONAZOL (epoxiconazole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the oat culture from 0.5 to 6.0 mg/kg.

Products Covered: HS Code(s): 1004; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution number 712, 16 September 2019, regarding the active ingredient  F70 - FLUENSULFONA (fluensulfone) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient F70 - FLUENSULFONA (fluensulfone) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the garlic and onion cultures with MRL of 0.05 mg/kg and safety security period "not determined" in the modality of pre-planting use (application); -includes the beetroot, arracacha, melon and watermelon cultures with MRL of 0.2 mg/kg and safety security period "not determined" in the modality of pre-planting use (application);- includes the tobacco and duboisia cultures with MRL and safety security period of "Non-food use" in the modality of soil use (application);- changes the phrase at item "j": "for the purpose of residue definition for conformity with MRL, it will be considered the sum of the ingredient Fluensulfona (fluensulfone) and its acid metabolit 3,4,4- trifluorobut-3-eno-1-sulfônico (synonyms: butene-sulfonic acid (BSA) and M-3637), expressed as equivalent of  fluensulfone, and for the dietary risk assessment it will be considered the ingredient of fluensulfone".

Products Covered: HS Code(s): 070320, 071220, 0706, 08071, 2401, 0714900011, duboisia; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 722, 16 September 2019, regarding the active ingredient F43 - FIPRONIL (fipronil) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient F43 - FIPRONIL (fipronil) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modalities of foliar and seeding aplication:- includes the acacia, black wattle, araucaria, paricá, pinus, populus, rubber tree and teak cultures with MRL and safety security period of "Non-food use".

Products Covered: HS Code(s): 4407, 44219090, 44129990, 44071000950, 44079710, 44072910, 44032200, 44071020, black wattle, parica; ICS Code(s): 13, 65

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

Draft resolution number 723, 16 September 2019, regarding the active ingredient  E29 - ETIPROLE (ethiprole) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 25 September 2019 | Final date for Comment: 18 November 2019

This Draft resolution incorporates the following changes for the active ingredient E29 - ETIPROLE (ethiprole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the soya culture with MRL of 0.08 mg/kg and safety security period of 14 days;- changes the phrase at item "j": "for the purpose of residue definition for conformity with MRL, it will be considered the active ingredient ethiprole, and for the dietary risk assessment it will be considered the sum of the ingredient ethiproleof and its metabolits 5-amino-1-(2,6-dichloro-4-trifluoromethylphenyl)-4-ethylsulfonylpyrazole-3- carbonitrile (RPA 097973) and 5-amino-1-(2,6-dichloro-4-trifluoromethylphenyl)-4- ethylsulfonylpyrazole-3-carboxamide (RPA 112916), expressed as ethiprole.".

Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

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