Andean Technical Regulation establishing microbiological technical specifications for cosmetics The Plurinational State of Bolivia, on behalf of Colombia, Ecuador and Peru, as Andean Community member countries, hereby advises that the draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics, notified in document G/TBT/N/BOL/17-G/TBT/N/COL/239-G/TBT/N/ECU/476-G/TBT/N/PER/116 of 24 September 2019, has been approved by means of Andean Community General Secretariat Resolution No. 2120, published in the Official Gazette of the Cartagena Agreement on 17 December 2019, and will enter into force on 27 May 2020. Member countries are responsible for duly implementing the Regulation. http://www.comunidadandina.org/DocOficialesFiles/Gacetas/Gaceta%203847.pdf
Distribution date: 17 June 2020
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: Addendum to Regular Notification
Andean Technical Regulation establishing microbiological technical specifications for cosmetics The Plurinational State of Bolivia, on behalf of Colombia, Ecuador and Peru, as Andean Community member countries, hereby advises that the draft Andean Technical Regulation establishing microbiological technical specifications for cosmetics, notified in document G/TBT/N/BOL/17-G/TBT/N/COL/239-G/TBT/N/ECU/476-G/TBT/N/PER/116 of 24 September 2019, has been approved by means of Andean Community General Secretariat Resolution No. 2120, published in the Official Gazette of the Cartagena Agreement on 17 December 2019, and will enter into force on 27 May 2020. Member countries are responsible for duly implementing the Regulation. http://www.comunidadandina.org/DocOficialesFiles/Gacetas/Gaceta%203847.pdf
Distribution date: 17 June 2020
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: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 301, 21 August 2019 – previously notified through G/TBT/N/BRA/870 – which adopts the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018, was rectified. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 346, 12 March 2020 – previously notified through G/TBT/N/BRA/984 – which establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 385, 12 May 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Code(s): 29, 2936, 2937, 2941, 30, 3001, 3002, 3003, 3004, 3005, 3006. (pharmaceutical products, active pharmaceutical ingredients, and healthcare products)
Regulation Type: Addendum to Regular Notification
The Resolution – RDC number 346, 12 March 2020 – previously notified through G/TBT/N/BRA/984 – which establishes extraordinary and temporary criteria and procedure for Good Manufacture Practice Guidelines for market authorization and post-market registration amendments of Active Pharmaceutical Ingredients, medicines, and healthcare products due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 385, 12 May 2020. The final text is available only in Portuguese and can be downloaded at:
Distribution date: 15 June 2020
Products Covered: HS Code(s): 29, 2936, 2937, 2941, 30, 3001, 3002, 3003, 3004, 3005, 3006. (pharmaceutical products, active pharmaceutical ingredients, and healthcare products)
Regulation Type: Addendum to Regular Notification
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program
Distribution date: 15 June 2020 | Final date for Comment: 27 July 2020
Notice of proposed rulemaking - Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list certain substances in the refrigeration and air conditioning sector and the foam blowing sector. For the retail food refrigeration-- medium-temperature stand-alone units (new) end-use, EPA is proposing to list substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is proposing to list substitutes as acceptable subject to use conditions. For the foam blowing sector, extruded polystyrene: Boardstock and billet end-use, EPA is proposing to list substitutes as acceptable. This action also proposes to remove an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions.
Products Covered: Chemical substances
Regulation Type: Regular notification
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