Regulatory Updates
DUS 2129: 2019, Medical ultrasound gel — Specification, First edition
Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019
The Draft Uganda standard specifies the requirements, sampling and methods of test of medical ultrasound gels.
Products Covered: Medical ultrasound gel
Regulation Type: Regular notification
Decreto Poder Ejecutivo (Executive Decree)
Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019
The notified Executive Decree prohibits the import, export, manufacture, sale, use, possession and marketing of veterinary products containing colistin in their composition, either alone or combined with other chemical products, in the raw material state, finished products or products incorporated in animal feed.
Products Covered: Veterinary products containing colistin in their composition
Regulation Type: Regular notification
Decreto Poder Ejecutivo (Executive Decree)
Distribution date: 08 April 2019 | Final date for Comment: 07 June 2019
The notified Executive Decree prohibits the import, export, manufacture, sale, use, possession and marketing of veterinary products containing colistin in their composition, either alone or combined with other chemical products, in the raw material state, finished products or products incorporated in animal feed.
Products Covered: Veterinary products containing colistin in their composition
Regulation Type: Regular notification
Beverages: Bottled Water, Proposed Rule
Distribution date: 05 April 2019 | Final date for Comment: 01 June 2019
The Food and Drug Administration (FDA) is proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L). This action, if finalized, will revise the current allowable levels for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action, if finalized, will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).
Products Covered: HS Code(s): 2201; ICS Code(s): 67
Regulation Type: Regular notification
Beverages: Bottled Water, Proposed Rule
Distribution date: 05 April 2019 | Final date for Comment: 01 June 2019
The Food and Drug Administration (FDA) is proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L). This action, if finalized, will revise the current allowable levels for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action, if finalized, will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).
Products Covered: HS Code(s): 2201; ICS Code(s): 67
Regulation Type: Regular notification
Letter of the Committee for Veterinary Control and Supervision of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of a temporary restriction on the importation to the territory of the Republic of Kazakhstan of live birds, poultry meat, poultry products and used equipment
Distribution date: 05 April 2019
On the basis of the official notification of the World Organisation for Animal Health, the Committee for Veterinary Control and Supervision of the Ministry of Agriculture of Kazakhstan reports outbreaks of Highly Pathogenic Avian Influenza (HPAI) registered in the Voronezh region, Russian Federation. In this regard, since 8 February 2019, temporary restrictions are imposed on the importation of live poultry and hatching eggs, down and feathers, poultry meat and all kinds of poultry products that have not undergone heat treatment (not less than 70 °C), feed and feed additives for birds (except feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermic treatment (feathered game), as well as used equipment for keeping, slaughter and cutting of birds.
Products Covered: Live birds and hatching eggs, down and feather, poultry
Regulation Type: Emergency notifications (SPS)
Letter of the Committee for Veterinary Control and Supervision of the Ministry of Agriculture of the Republic of Kazakhstan on the introduction of a temporary restriction on the importation to the territory of the Republic of Kazakhstan of live birds, poultry meat, poultry products and used equipment
Distribution date: 05 April 2019
On the basis of the official notification of the World Organisation for Animal Health, the Committee for Veterinary Control and Supervision of the Ministry of Agriculture of Kazakhstan reports outbreaks of Highly Pathogenic Avian Influenza (HPAI) registered in the Voronezh region, Russian Federation. In this regard, since 8 February 2019, temporary restrictions are imposed on the importation of live poultry and hatching eggs, down and feathers, poultry meat and all kinds of poultry products that have not undergone heat treatment (not less than 70 °C), feed and feed additives for birds (except feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermic treatment (feathered game), as well as used equipment for keeping, slaughter and cutting of birds.
Products Covered: Live birds and hatching eggs, down and feather, poultry
Regulation Type: Emergency notifications (SPS)
Proyecto de Tercera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 006 (3R) "Extintores portátiles y agentes de extinción de fuego" (Draft third revision (3R) of Ecuadorian Standardization Institute Technical Regulation (PRTE INEN) No. 006 "Portable fire extinguishers and fire-fighting agents") (11 pages, in Spanish)
Distribution date: 03 April 2019 | Final date for Comment: 02 June 2019
The notified draft Technical Regulation establishes the requirements to be met by portable fire extinguishers and fire-fighting agents, prior to the marketing of domestic and imported products, with the aim of protecting human safety and preventing misleading practices. The notified Technical Regulation applies to the following products: 1. Portable fire extinguishers with a capacity of up to 27kg, regardless of the fire-fighting agent used, the quantity of fire-fighting agent and the class of fire for which the extinguisher is intended; 2. Portable wheeled fire extinguishers with a capacity of up to 125L (33 gallons) for foam, and from 13.6kg to 158.8kg (30lb to 350lb) for other types of extinguishers, regardless of the fire-fighting agent used, the quantity of fire-fighting agent and the class of fire for which the extinguisher is intended; 3. Dry-chemical and CO2 fire-fighting agents, water-based fire-fighting agents and clean agents. The notified Technical Regulation does not apply to permanently-installed fire-extinguishing systems, even where parts of such systems are portable (such as hoses and nozzles attached to a fixed supply of fire-fighting agent).
Products Covered: Preparations and charges for fire-extinguishers; charged fire-extinguishing grenades (excl. full or empty fire-extinguishing devices, whether or not portable, unmixed chemically undefined products with fire-extinguishing properties in other forms) (HS code(s): 3813); Preparations and charges for fire-extinguishers; charged fire-extinguishing grenades (excl. full or empty fire-extinguishing devices, whether or not portable, unmixed chemically undefined products with fire-extinguishing properties in other forms) (HS code(s): 381300); Fire extinguishers, whether or not charged (excl. fire-extinguishing bombs and grenades) (HS code(s): 842410); (ICS code(s): 13.220)
Regulation Type: Regular notification
Proyecto de Tercera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 006 (3R) "Extintores portátiles y agentes de extinción de fuego" (Draft third revision (3R) of Ecuadorian Standardization Institute Technical Regulation (PRTE INEN) No. 006 "Portable fire extinguishers and fire-fighting agents") (11 pages, in Spanish)
Distribution date: 03 April 2019 | Final date for Comment: 02 June 2019
The notified draft Technical Regulation establishes the requirements to be met by portable fire extinguishers and fire-fighting agents, prior to the marketing of domestic and imported products, with the aim of protecting human safety and preventing misleading practices. The notified Technical Regulation applies to the following products: 1. Portable fire extinguishers with a capacity of up to 27kg, regardless of the fire-fighting agent used, the quantity of fire-fighting agent and the class of fire for which the extinguisher is intended; 2. Portable wheeled fire extinguishers with a capacity of up to 125L (33 gallons) for foam, and from 13.6kg to 158.8kg (30lb to 350lb) for other types of extinguishers, regardless of the fire-fighting agent used, the quantity of fire-fighting agent and the class of fire for which the extinguisher is intended; 3. Dry-chemical and CO2 fire-fighting agents, water-based fire-fighting agents and clean agents. The notified Technical Regulation does not apply to permanently-installed fire-extinguishing systems, even where parts of such systems are portable (such as hoses and nozzles attached to a fixed supply of fire-fighting agent).
Products Covered: Preparations and charges for fire-extinguishers; charged fire-extinguishing grenades (excl. full or empty fire-extinguishing devices, whether or not portable, unmixed chemically undefined products with fire-extinguishing properties in other forms) (HS code(s): 3813); Preparations and charges for fire-extinguishers; charged fire-extinguishing grenades (excl. full or empty fire-extinguishing devices, whether or not portable, unmixed chemically undefined products with fire-extinguishing properties in other forms) (HS code(s): 381300); Fire extinguishers, whether or not charged (excl. fire-extinguishing bombs and grenades) (HS code(s): 842410); (ICS code(s): 13.220)
Regulation Type: Regular notification
TITLE: Methylene Chloride; Regulation of Paint and Coating Removal for Consumer Use Under TSCA Section 6(a) AGENCY: Environmental Protection Agency (EPA) ACTION: Final rule SUMMARY: Methylene chloride, also called dichloromethane, is a volatile chemical used in paint and coating removal products. In this final rule, EPA has determined that the use of methylene chloride in consumer paint and coating removal presents an unreasonable risk of injury to health due to acute human lethality. In order to address the unreasonable risk, EPA is prohibiting the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer paint and coating removal, including distribution to and by retailers; requiring manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions; and requiring recordkeeping. While EPA proposed a determination of unreasonable risk from the use of methylene chloride in commercial paint and coating removal, EPA is not finalizing that determination in this rule. EPA is soliciting comment, through an advance notice of proposed rulemaking (ANPRM) published elsewhere in this issue of the Federal Register, on questions related to a potential training, certification, and limited access program as an option for risk management for all of the commercial uses of methylene chloride in paint and coating removal. This final rule is effective 28 May 2019.
Distribution date: 03 April 2019
Products Covered: Methylene chloride and N-Methylpyrrolidone
Regulation Type: Addendum to Regular Notification
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