Proyecto de Real Decreto por el que se Regulan los Productos Zoosanitarios (Draft royal decree regulating animal health products). (51 pages, in Spanish)

Distribution date: 25 February 2019 | Final date for Comment: 26 April 2019
Requirements are established for the authorization, registration, marketing and use of animal health products. The following items are excluded: veterinary medicines; homeopathic veterinary medicines; medicated feeding stuffs; biocides used in livestock settings; biocidal animal hygiene, care and handling products; animal health supplies and devices; those related to reproduction (except preservatives and diluents for semen, ova and embryos); animal feeding stuffs and animal identification products, which will be subject to specific regulations. Also excluded are all health products for which there has been a communication or authorization under Royal Decree No. 414/1996 of 1 March, on the regulation of health products, and which are intended for use in veterinary settings or in animals, with the same composition, packaging and labelling as when communicated or authorized by the Spanish Agency for Medicines and Health Products; importation of live animals not subject to harmonized European Union regulations and having Spain as their final destination, including invasive species
Products Covered: HS codes 28, 29 (excluding 29.35, 29.36, 29.37, 29.39 and 29.40), 30.0610, 30.06.20.00 and 38.22.
Regulation Type: Regular notification
DUS 2115:2018, Fly ash used for cement and concrete, First Edition

Distribution date: 26 February 2019 | Final date for Comment: 27 April 2019
The Standard specifies the terms and definition, classification, grade, technical requirements, test method, inspection rules, packaging, marking, transportation and storage of the fly ash used for cement and concrete. The Standard is applicable to the fly ash used as admixture at time of mixing mortar and concrete, and fly ash used as active addition at time of cement production.
Products Covered: Fly ash
Regulation Type: Regular notification
DUS 2036: 2019, Food grade nitrogen – Specification, First Edition.

Distribution date: 26 February 2019 | Final date for Comment: 27 April 2019
This Draft Uganda Standard specifies requirements, sampling and test methods for food grade nitrogen.
Products Covered: Food grade nitrogen
Regulation Type: Regular notification
DUS 2127: 2019, Food grade gelatin – Specification, First Edition.

Distribution date: 26 February 2019 | Final date for Comment: 27 April 2019
This Draft Uganda Standard specifies requirements, sampling and test methods for food grade gelatin, also known as edible gelatin.
Products Covered: Gelatin, whether or not in square or rectangular sheets, whether or not surface-worked or coloured, and gelatin derivatives; isinglass; other glues of animal origin (excl. those packaged as glue for retail sale and weighing
Regulation Type: Regular notification
Proyecto de Real Decreto por el que se Regulan los Productos Zoosanitarios (Draft royal decree regulating animal health products). (51 pages, in Spanish)

Distribution date: 25 February 2019 | Final date for Comment: 26 April 2019
Requirements are established for the authorization, registration, marketing and use of animal health products. The following items are excluded: veterinary medicines; homeopathic veterinary medicines; medicated feeding stuffs; biocides used in livestock settings; biocidal animal hygiene, care and handling products; animal health supplies and devices; those related to reproduction (except preservatives and diluents for semen, ova and embryos); animal feeding stuffs and animal identification products, which will be subject to specific regulations. Also excluded are all health products for which there has been a communication or authorization under Royal Decree No. 414/1996 of 1 March, on the regulation of health products, and which are intended for use in veterinary settings or in animals, with the same composition, packaging and labelling as when communicated or authorized by the Spanish Agency for Medicines and Health Products; importation of live animals not subject to harmonized European Union regulations and having Spain as their final destination, including invasive species
Products Covered: HS codes 28, 29 (excluding 29.35, 29.36, 29.37, 29.39 and 29.40), 30.0610, 30.06.20.00 and 38.22.
Regulation Type: Regular notification
Draft Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2019

Distribution date: 01 March 2019 | Final date for Comment: 30 April 2019
Draft Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2019 related to standards for fortification of species identified milk, multigrain atta and processed food products.
Products Covered: Standards for fortification of species identified milk, multigrain atta and processed food products
Regulation Type: Regular notification
Draft Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2019

Distribution date: 01 March 2019 | Final date for Comment: 30 April 2019
Draft Food Safety and Standards (Fortification of Foods) Amendment Regulations, 2019 related to standards for fortification of species identified milk, multigrain atta and processed food products.
Products Covered: Standards for fortification of species identified milk, multigrain atta and processed food products
Regulation Type: Regular notification
Reglamento de la Ley 30681, Ley que regula el uso medicinal y terapéutico, del Cannabis y sus derivados (Regulations implementing Law No. 30681 regulating the medicinal and therapeutic use of cannabis and its derivatives) (13 pages, in Spanish)

Distribution date: 05 March 2019 | Final date for Comment: 29 April 2025
The purpose of the notified text is to establish: - rules to regulate the medicinal and therapeutic use of cannabis and its derivatives; and - information on the requirements for the delivery of research, production, import and marketing licences that enable access to medicinal cannabis and its derivatives.
Products Covered: Plants, parts of plants, incl. seeds and fruits, used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered (excl. liquorice and ginseng roots, coca leaf and poppy straw) (HS code(s): 121190); Natural gums, resins, gum-resins, balsams and other natural oleoresins (excl. gum Arabic) (HS code(s): 130190); Vegetable saps and extracts (excl. liquorice, hops, pryrethrum, roots of plants containing rotenone and opium) (HS code(s): 130219); Tetrahydrocannabinols "all isomers" (HS code(s): 293295); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic purposes, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. medicaments containing antibiotics, medicaments containing hormones or steroids used as hormones, but not containing antibiotics, medicaments containing alkaloids or derivates thereof but not containing hormones or antibiotics and medicaments containing provitamins, vitamins or derivates thereof used as vitamins) (HS code(s): 300490); Pharmaceutics (ICS code(s): 11.120)
Regulation Type: Regular notification
Notice of Modification to the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents, and the List of Permitted Sequestering Agents to Enable the Use of Potassium Pyrophosphate, Tetrabasic in Unstandardized Foods - Reference Number: NOM/ADM-0128

Distribution date: 08 March 2019 | Final date for Comment: 18 May 2019
Health Canada's Food Directorate completed a detailed safety assessment of a food additive submission seeking approval for the use of potassium pyrophosphate, tetrabasic in unstandardized foods. Potassium pyrophosphate, tetrabasic is already permitted for use as a food additive in various foods as specified in the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, the List of Permitted Food Additives with Other Accepted Uses, and the List of Permitted Sequestering Agents. As no safety concerns were raised through Health Canada's assessment, the Department has enabled the use of this food additive as described in the information document below by modifying the List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents, the List of Permitted pH Adjusting Agents, Acid-Reacting Materials and Water Correcting Agents, and the List of Permitted Sequestering Agents, effective 5 March 2019. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.
Products Covered: Potassium pyrophosphate, tetrabasic (ICS Code: 67.220.20)
Regulation Type: Regular notification
Reglamento de la Ley 30681, Ley que regula el uso medicinal y terapéutico, del Cannabis y sus derivados (Regulations implementing Law No. 30681 regulating the medicinal and therapeutic use of cannabis and its derivatives) (13 pages, in Spanish)

Distribution date: 05 March 2019 | Final date for Comment: 29 April 2025
The purpose of the notified text is to establish: - rules to regulate the medicinal and therapeutic use of cannabis and its derivatives; and - information on the requirements for the delivery of research, production, import and marketing licences that enable access to medicinal cannabis and its derivatives.
Products Covered: Plants, parts of plants, incl. seeds and fruits, used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered (excl. liquorice and ginseng roots, coca leaf and poppy straw) (HS code(s): 121190); Natural gums, resins, gum-resins, balsams and other natural oleoresins (excl. gum Arabic) (HS code(s): 130190); Vegetable saps and extracts (excl. liquorice, hops, pryrethrum, roots of plants containing rotenone and opium) (HS code(s): 130219); Tetrahydrocannabinols "all isomers" (HS code(s): 293295); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic purposes, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. medicaments containing antibiotics, medicaments containing hormones or steroids used as hormones, but not containing antibiotics, medicaments containing alkaloids or derivates thereof but not containing hormones or antibiotics and medicaments containing provitamins, vitamins or derivates thereof used as vitamins) (HS code(s): 300490); Pharmaceutics (ICS code(s): 11.120)
Regulation Type: Regular notification
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