Regulatory Updates

Distribution date: 27 April 2022 | Final date for Comment: 27 May 2022

The test for abnormal toxicity (“test for freedom from abnormal toxicity”) will be deleted from monographs for “Freeze-Dried Japanese Encephalitis Vaccine”, “Pneumoniae Vaccine Polyvalent”, “Pneumococcal 10-valent conjugate vaccine”, “Freeze-Dried Haemophilus Type b Vaccine (Tetanus Toxoid Conjugate)”.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard provide general guidelines for herbal cosmetics. This guideline does not cover herbal products which therapeutical claims are made.

Products Covered: Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), incl. sunscreen or suntan preparations (excl. medicaments, lip and eye make-up preparations, manicure or pedicure preparations and make-up or skin care powders, incl. baby powders) (HS code(s): 330499); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard provide general guidelines for herbal cosmetics. This guideline does not cover herbal products which therapeutical claims are made.

Products Covered: Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), incl. sunscreen or suntan preparations (excl. medicaments, lip and eye make-up preparations, manicure or pedicure preparations and make-up or skin care powders, incl. baby powders) (HS code(s): 330499); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 25 April 2022

The Food and Drug Administration (FDA or we) is revising 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), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, 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 2015 recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action 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).  This rule is effective 21 June 2022. The compliance date is 17 October 2022.

Products Covered: HS Code(s): 2201; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 25 April 2022

The Food and Drug Administration (FDA or we) is revising 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), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, 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 2015 recommendation by the US Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action 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).  This rule is effective 21 June 2022. The compliance date is 17 October 2022.

Products Covered: HS Code(s): 2201; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard specifies requirements, sampling and test methods for wax-based polishes in form of paste and liquid applicable to polishes intended for use on plastics, leather, rubber, finished furniture and car interiors like dashboards and leather seats. 

Products Covered: Polishes, creams and similar preparations, for footwear or leather, whether or not in the form of paper, wadding, felt, nonwovens, cellular plastics or cellular rubber, impregnated, coated or covered with such preparations (excl. artificial and prepared waxes of heading 3404) (HS code(s): 340510); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard specifies requirements, sampling and test methods for wax-based polishes in form of paste and liquid applicable to polishes intended for use on plastics, leather, rubber, finished furniture and car interiors like dashboards and leather seats. 

Products Covered: Polishes, creams and similar preparations, for footwear or leather, whether or not in the form of paper, wadding, felt, nonwovens, cellular plastics or cellular rubber, impregnated, coated or covered with such preparations (excl. artificial and prepared waxes of heading 3404) (HS code(s): 340510); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard specifies requirements, sampling and test methods for wax-emulsion type shoe cream suitable for general application to leather footwear.

Products Covered: Polishes, creams and similar preparations, for footwear or leather, whether or not in the form of paper, wadding, felt, nonwovens, cellular plastics or cellular rubber, impregnated, coated or covered with such preparations (excl. artificial and prepared waxes of heading 3404) (HS code(s): 340510); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 24 June 2022

This Draft Tanzania Standard specifies requirements, sampling and test methods for wax-emulsion type shoe cream suitable for general application to leather footwear.

Products Covered: Polishes, creams and similar preparations, for footwear or leather, whether or not in the form of paper, wadding, felt, nonwovens, cellular plastics or cellular rubber, impregnated, coated or covered with such preparations (excl. artificial and prepared waxes of heading 3404) (HS code(s): 340510); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 25 April 2022 | Final date for Comment: 17 June 2022

Notice of proposed rulemaking - FRA proposes to amend its Safety Glazing Standards for exterior windows on railroad equipment to codify long-standing waivers, add a new testing option to improve consistency of glazing testing, and revise outdated section headings. The proposed changes would update and clarify existing requirements to maintain and, in some cases, enhance safety, while reducing unnecessary costs. Codification of the waivers as proposed is also consistent with the Infrastructure Investment and Jobs Act, and would enable FRA to more efficiently use its inspection resources.

Products Covered: Safety glazing standards; Prepared pigments, prepared opacifiers and prepared colours, vitrifiable enamels and glazes, engobes, liquid lustres and similar preparations of a kind used in the ceramic, enamelling or glass industry; glass frit and other glass in the form of powder, granules or flakes (HS code(s): 3207); Quality (ICS code(s): 03.120); Test conditions and procedures in general (ICS code(s): 19.020); Railway rolling stock in general (ICS code(s): 45.060.01); Glass (ICS code(s): 81.040)

Regulation Type: Regular notification