Proyecto de Reglamento Técnico Andino sobre Buenas Prácticas de Manufactura (BPM) en Productos Cosméticos (Draft Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products) (21 pages, in Spanish)

Distribution date: 17 January 2019 | Final date for Comment: 16 March 2019
The draft includes the following: purpose, scope and definitions; GMP requirements (personnel; facilities, production and quality control), administrative and conformity assessment procedures, control and oversight, supplementary provisions and Annex 1 (products covered).
Products Covered: 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); Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders (excl. dentifrices and yarn used to clean between the teeth "dental floss") (HS code(s): 330690); Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Personal deodorants and antiperspirants (HS code(s): 330720); Perfumed bath salts and other bath and shower preparations (HS code(s): 330730); Depilatories and other perfumery, toilet or cosmetic preparations, n.e.s. (HS code(s): 330790); 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, for toilet use, incl. medicated products (HS code(s): 340111); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 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 code(s): 340130); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Proyecto de Reglamento Técnico Andino sobre Buenas Prácticas de Manufactura (BPM) en Productos Cosméticos (Draft Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products) (21 pages, in Spanish)

Distribution date: 17 January 2019 | Final date for Comment: 16 March 2019
The draft includes the following: purpose, scope and definitions; GMP requirements (personnel; facilities, production and quality control), administrative and conformity assessment procedures, control and oversight, supplementary provisions and Annex 1 (products covered).
Products Covered: 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); Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders (excl. dentifrices and yarn used to clean between the teeth "dental floss") (HS code(s): 330690); Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Personal deodorants and antiperspirants (HS code(s): 330720); Perfumed bath salts and other bath and shower preparations (HS code(s): 330730); Depilatories and other perfumery, toilet or cosmetic preparations, n.e.s. (HS code(s): 330790); 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, for toilet use, incl. medicated products (HS code(s): 340111); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 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 code(s): 340130); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Proyecto de Reglamento Técnico Andino sobre Buenas Prácticas de Manufactura (BPM) en Productos Cosméticos (Draft Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products) (21 pages, in Spanish)

Distribution date: 17 January 2019 | Final date for Comment: 16 March 2019
The draft includes the following: purpose, scope and definitions; GMP requirements (personnel; facilities, production and quality control), administrative and conformity assessment procedures, control and oversight, supplementary provisions and Annex 1 (products covered).
Products Covered: 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); Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders (excl. dentifrices and yarn used to clean between the teeth "dental floss") (HS code(s): 330690); Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Personal deodorants and antiperspirants (HS code(s): 330720); Perfumed bath salts and other bath and shower preparations (HS code(s): 330730); Depilatories and other perfumery, toilet or cosmetic preparations, n.e.s. (HS code(s): 330790); 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, for toilet use, incl. medicated products (HS code(s): 340111); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 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 code(s): 340130); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Proyecto de Reglamento Técnico Andino sobre Buenas Prácticas de Manufactura (BPM) en Productos Cosméticos (Draft Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products) (21 pages, in Spanish)

Distribution date: 17 January 2019 | Final date for Comment: 16 March 2019
The draft includes the following: purpose, scope and definitions; GMP requirements (personnel; facilities, production and quality control), administrative and conformity assessment procedures, control and oversight, supplementary provisions and Annex 1 (products covered).
Products Covered: 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); Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders (excl. dentifrices and yarn used to clean between the teeth "dental floss") (HS code(s): 330690); Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Personal deodorants and antiperspirants (HS code(s): 330720); Perfumed bath salts and other bath and shower preparations (HS code(s): 330730); Depilatories and other perfumery, toilet or cosmetic preparations, n.e.s. (HS code(s): 330790); 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, for toilet use, incl. medicated products (HS code(s): 340111); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 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 code(s): 340130); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Proyecto de Reglamento Técnico Andino sobre Buenas Prácticas de Manufactura (BPM) en Productos Cosméticos (Draft Andean Technical Regulation on Good Manufacturing Practices (GMP) for Cosmetic Products) (21 pages, in Spanish)

Distribution date: 17 January 2019 | Final date for Comment: 16 March 2019
The draft includes the following: purpose, scope and definitions; GMP requirements (personnel; facilities, production and quality control), administrative and conformity assessment procedures, control and oversight, supplementary provisions and Annex 1 (products covered).
Products Covered: 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); Dentifrices, incl. those used by dental practitioners (HS code(s): 330610); Preparations for oral or dental hygiene, incl. denture fixative pastes and powders (excl. dentifrices and yarn used to clean between the teeth "dental floss") (HS code(s): 330690); Shaving preparations, incl. pre-shave and after-shave products (HS code(s): 330710); Personal deodorants and antiperspirants (HS code(s): 330720); Perfumed bath salts and other bath and shower preparations (HS code(s): 330730); Depilatories and other perfumery, toilet or cosmetic preparations, n.e.s. (HS code(s): 330790); 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, for toilet use, incl. medicated products (HS code(s): 340111); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 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 code(s): 340130); Cosmetics. Toiletries (ICS code(s): 71.100.70)
Regulation Type: Regular notification
Draft resolution number 589, 21 January 2019, regarding the active ingredient F68 - FLUXAPIROXADE 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

Distribution date: 23 January 2019 | Final date for Comment: 20 February 2019
This Draft resolution incorporates the following changes for the active ingredient F68 - FLUXAPIROXADE from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- Inclusion of cultures of pineapple, anonaceous, kiwifruit and pomegrenate with MRL of 0.7 mg/kg and safety security period of 7 days;- Inclusion of cultures of sweet potato, yacon potato, beet, cará, ginger, yam, manioc (cassava), mandioquinha salsa, turnip and radish with MRL of 0.07 mg/kg and safety security period of 7 days;- Inclusion of cultures of chickpeas, lentils and cowpeas with MRL of 0.03 mg/kg and safety security period of 14 days;- Inclusion of cultures of alstroemeria, alyssum, amaryllis, azalea, toadflax, Indic cane, celulosia, coleus, clove, duboisia, euonumus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisanthus, daisy, pinus, pittosporum, ruscus, salvia, sedum makinoi, rubber tree, verbena, vinca and zinnia with "Non determined" MRL and safety security period;- Changes MRL from 0.1 to 0.3 mg/kg for açai, coconut, dendê, macadamia, pinion and pupunha cultures;- Changes MRL from 0.01 to 0.03 mg/kg for peanut and potato cultures;- Changes MRL from 0.02 to 0.07 mg/kg for carrot cultures;- Changes MRL from 0.5 to 0.7 mg/kg for mango culture;- Changes safety security period from 14 to 7 days fot cotton culture.
Products Covered: HS Code(s): 071420, 080430, 081050, 121291, 091010, 071410, 0706, 071320, 071340, 060230, 0907, 330121, 0801, 071010, 070610, 080450, 52; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 589, 21 January 2019, regarding the active ingredient F68 - FLUXAPIROXADE 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

Distribution date: 23 January 2019 | Final date for Comment: 20 February 2019
This Draft resolution incorporates the following changes for the active ingredient F68 - FLUXAPIROXADE from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- Inclusion of cultures of pineapple, anonaceous, kiwifruit and pomegrenate with MRL of 0.7 mg/kg and safety security period of 7 days;- Inclusion of cultures of sweet potato, yacon potato, beet, cará, ginger, yam, manioc (cassava), mandioquinha salsa, turnip and radish with MRL of 0.07 mg/kg and safety security period of 7 days;- Inclusion of cultures of chickpeas, lentils and cowpeas with MRL of 0.03 mg/kg and safety security period of 14 days;- Inclusion of cultures of alstroemeria, alyssum, amaryllis, azalea, toadflax, Indic cane, celulosia, coleus, clove, duboisia, euonumus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisanthus, daisy, pinus, pittosporum, ruscus, salvia, sedum makinoi, rubber tree, verbena, vinca and zinnia with "Non determined" MRL and safety security period;- Changes MRL from 0.1 to 0.3 mg/kg for açai, coconut, dendê, macadamia, pinion and pupunha cultures;- Changes MRL from 0.01 to 0.03 mg/kg for peanut and potato cultures;- Changes MRL from 0.02 to 0.07 mg/kg for carrot cultures;- Changes MRL from 0.5 to 0.7 mg/kg for mango culture;- Changes safety security period from 14 to 7 days fot cotton culture.
Products Covered: HS Code(s): 071420, 080430, 081050, 121291, 091010, 071410, 0706, 071320, 071340, 060230, 0907, 330121, 0801, 071010, 070610, 080450, 52; ICS Code(s): 13, 65
Regulation Type: Regular notification
Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements On 6 November 2008, the Government of the Republic of El Salvador notified, in document G/TBT/N/SLV/126, the draft regulation "RTCA No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements", whose purpose was to establish provisions governing the sanitary registration and control of veterinary drugs, related products and establishments. The regulation applies to veterinary drugs and related products and to establishments engaged in the registration, manufacture, marketing, dispensing or distribution, fractioning or storage thereof in the States Parties. The sanitary registration of raw materials for the preparation of veterinary drugs and related products and compounded veterinary formulations is excluded from the scope of the regulation and remains subject to the domestic laws of each State Party. The purpose of the present Addendum is to notify WTO Members that the regulation has been updated. They will have 60 days from the date of this notification to make comments. The document is available electronically from: Ministerio de Economía (Ministry of the Economy) Dirección de Administración de Tratados Comerciales (Directorate for the Administration of Trade Agreements) Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador Website: http://www.minec.gob.sv Tel.: (+503) 2590 5788 Email: [email protected] Organismo Salvadoreño de Reglamentación Técnica, OSARTEC (Salvadoran Technical Regulation Agency) 1ª Calle Poniente y Final 41 Av. Norte, N° 18 Colonia Flor Blanca San Salvador, El Salvador Website: http://www.osartec.gob.sv Tel.: (+503) 2590 5323; (+503) 2590 5331; (+503) 2590 5335 Email: [email protected]

Distribution date: 28 January 2019 | Final date for Comment: 29 April 2025
Products Covered: Pharmaceutical products: HS Chapter 30 (International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements On 6 November 2008, the Government of the Republic of El Salvador notified, in document G/TBT/N/SLV/126, the draft regulation "RTCA No. 65.05.51:08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements", whose purpose was to establish provisions governing the sanitary registration and control of veterinary drugs, related products and establishments. The regulation applies to veterinary drugs and related products and to establishments engaged in the registration, manufacture, marketing, dispensing or distribution, fractioning or storage thereof in the States Parties. The sanitary registration of raw materials for the preparation of veterinary drugs and related products and compounded veterinary formulations is excluded from the scope of the regulation and remains subject to the domestic laws of each State Party. The purpose of the present Addendum is to notify WTO Members that the regulation has been updated. They will have 60 days from the date of this notification to make comments. The document is available electronically from: Ministerio de Economía (Ministry of the Economy) Dirección de Administración de Tratados Comerciales (Directorate for the Administration of Trade Agreements) Alameda Juan Pablo II y Calle Guadalupe, Plan Maestro, San Salvador, El Salvador Website: http://www.minec.gob.sv Tel.: (+503) 2590 5788 Email: [email protected] Organismo Salvadoreño de Reglamentación Técnica, OSARTEC (Salvadoran Technical Regulation Agency) 1ª Calle Poniente y Final 41 Av. Norte, N° 18 Colonia Flor Blanca San Salvador, El Salvador Website: http://www.osartec.gob.sv Tel.: (+503) 2590 5323; (+503) 2590 5331; (+503) 2590 5335 Email: [email protected]

Distribution date: 28 January 2019 | Final date for Comment: 29 April 2025
Products Covered: Pharmaceutical products: HS Chapter 30 (International Classification for Standards (ICS) code 65.020.30)
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 65.05.51.08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements

Distribution date: 30 January 2019 | Final date for Comment: 31 March 2019
On 21 November 2008, the Government of the Republic of Honduras notified, in document G/SPS/N/HND/31, the draft regulation "RTCA No. 65.05.51.08: Veterinary drugs and related products, and establishments engaged in the manufacture, marketing, fractioning or storage thereof. Sanitary registration and control requirements", whose purpose was to establish provisions governing the sanitary registration and control of veterinary drugs, related products and establishments. The regulation applies to veterinary drugs and related products and to establishments engaged in the registration, manufacture, marketing, dispensing or distribution, fractioning or storage thereof in the States Parties. The sanitary registration of raw materials for the preparation of veterinary drugs and related products and compounded veterinary formulations is excluded from the scope of the regulation and remains subject to the domestic laws of each State Party. The purpose of the present addendum is to notify WTO Members that the regulation has been updated. They will have 60 days from the date of this notification to make comments.
Products Covered:
Regulation Type: Addendum to Regular Notification
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