Regulatory Updates

National Standard of the P.R.C., Feed Additive Part 2: Vitamins, Provitamins and Chemically Well-defined Substances Having Similar Effect—Cyanocobalamin Cobione (Vitamin B12)

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Distribution date: 08 February 2021 | Final date for Comment: 09 April 2021

This part specifies the technical requirements, sampling, test methods, inspection rules, labelling, packaging, transportation, storage and shelf life of feed additive -cyanocobalamin. This part is applicable to the fermentation broth containing cobalamin produced by microbial fermentation, and the crystal product of cyanocobalamin can be obtained by purification and crystallization. It is also applicable to the powder products with 0.1% to 2% specifications made from cyanocobalamin (vitamin B12) produced by fermentation as main material and calcium carbonate and corn starch as auxiliary materials.

Products Covered: Feed additive - Cyanocobalamin cobione (Vitamin B12)

Regulation Type: Regular notification

Standards of Information File for Toothpaste Notification

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Distribution date: 08 February 2021 | Final date for Comment: 09 April 2021

Detailed requirements about the information file submitted for notification of toothpaste products.

Products Covered: Toothpaste

Regulation Type: Regular notification

Standard of the P.R.C., Feed Additives —Part 9:Coloring Agents–4,4′-Diketo-β-Carotene(Canthaxanthin)

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Distribution date: 08 February 2021 | Final date for Comment: 09 April 2021

This part specifies the technical requirements, sampling, test methods, inspection rules, labelling, packaging, transportation and storage of feed additives-–4,4′-diketo-β-carotene (canthaxanthin). This part is applicable to the feed additives 96% –4,4′-diketo-β-carotene (canthaxanthin) products which are synthesized by chemical synthesis with β-carotene or vitamin A acetate as main raw material, and feed additive 10% –4,4′-diketo-β-carotene (canthaxanthin) product prepared by spray drying with the above mentioned product as raw material and added silica.

Products Covered: Feed additives-4,4′-diketo-β-carotene (canthaxanthin)

Regulation Type: Regular notification

Draft Ministerial Regulation on Synthetic Dyestuffs: Acid Dye (TIS 2532-25XX(20XX))

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Distribution date: 05 February 2021 | Final date for Comment: 06 April 2021

The draft ministerial regulation mandates synthetic dyestuffs: acid dye to conform with the standard for Synthetic Dyestuffs: Acid Dye (TIS 2532-25XX(20XX)). The Thai Industrial Standards Institute (TISI) is in the process of withdrawing the standard for Synthetic Dyestuffs: Acid Dye (TIS 2532-2556(2013)) and the standard for Synthetic Dyestuffs: Acid Dye (TIS 2532-25XX(20XX)) will be replaced. This draft standard covers only safety requirements of synthetic dyestuffs: acid dye for textile and leather products. It specifies safety requirements, packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Regular notification

Draft Ministerial Regulation on Synthetic Dyestuffs: Reactive Dye (TIS 740-25XX(20XX))

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Distribution date: 05 February 2021 | Final date for Comment: 06 April 2021

The draft ministerial regulation mandates synthetic dyestuffs: reactive dye to conform with the standard for Synthetic Dyestuffs: Reactive Dye (TIS 740-25XX(20XX)). The Thai Industrial Standards Institute (TISI) is in the process of withdrawing the standard for Synthetic Dyestuffs: Reactive Dye (TIS 740-2555(2012)) and the standard for Synthetic Dyestuffs: Reactive Dye (TIS 740-25XX(20XX)) will be replaced. This draft standard covers only safety requirements of synthetic dyestuffs: reactive dye for textile and leather products. It specifies safety requirements, packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Regular notification

Draft Ministerial Regulation on Synthetic Dyestuffs: Sulphur Dye (TIS 2344-25XX(20XX))

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Distribution date: 05 February 2021 | Final date for Comment: 06 April 2021

The draft ministerial regulation mandates synthetic dyestuffs: sulphur dye to conform with the standard for Synthetic Dyestuffs: Sulphur Dye (TIS 2344-25XX(20XX)). The Thai Industrial Standards Institute (TISI) is in the process of withdrawing the standard for Synthetic Dyestuffs: Sulphur Dye (TIS 2344-2555(2012)) and the standard for Synthetic Dyestuffs: Sulphur Dye (TIS 2344-25XX(20XX)) will be replaced. This draft standard covers only safety requirements of synthetic dyestuffs: sulphur dye for textile and leather products. It specifies safety requirements, packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Regular notification

Draft Ministerial Regulation on Synthetic Dyestuffs: Vat Dye (TIS 760-25XX(20XX))

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Distribution date: 05 February 2021 | Final date for Comment: 06 April 2021

The draft ministerial regulation mandates synthetic dyestuffs: vat dye to conform with the standard for Synthetic Dyestuffs: Vat Dye (TIS 760-25XX(20XX)). The Thai Industrial Standards Institute (TISI) is in the process of withdrawing the standard for Synthetic Dyestuffs: Vat Dye (TIS 760-2555(2012)) and the standard for Synthetic Dyestuffs: Vat Dye (TIS 760-25XX(20XX)) will be replaced. This draft standard covers only safety requirements of synthetic dyestuffs: vat dye for textile and leather products. It specifies safety requirements, packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Regular notification

Draft Ministerial Regulation on Synthetic Dyestuffs: Direct Dye (TIS 739-25XX(20XX))

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Distribution date: 05 February 2021 | Final date for Comment: 06 April 2021

The draft ministerial regulation mandates synthetic dyestuffs: direct dye to conform with the standard for Synthetic Dyestuffs: Direct Dye (TIS 739-25XX(20XX)). The Thai Industrial Standards Institute (TISI) is in the process of withdrawing the standard for Synthetic Dyestuffs: Direct Dye (TIS 739-2555(2012)) and the standard for Synthetic Dyestuffs: Direct Dye (TIS 739-25XX(20XX)) will be replaced. This draft standard covers only safety requirements of synthetic dyestuffs: direct dye for textile and leather products. It specifies safety requirements, packaging, marking and labelling, sampling and criteria for conformity and testing.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Regular notification

Technical regulation "Safety of paintwork materials"

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Distribution date: 02 February 2021 | Final date for Comment: 02 April 2021

Developed in accordance with the law of the Republic of Tajikistan "On technical regulation" in order to define single requirements for labeling, packaging and free circulation of paints on the territory of the Republic of Tajikistan

Products Covered: Safety of paintwork materials

Regulation Type: Regular notification

Resolution – RDC number 461, 22 January 2021

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Distribution date: 01 February 2021

The Resolution – RDC number 392, 26 May 2020 – previously notified through G/TBT/N/BRA/1032 – which establishes temporary and extraordinary criteria for the application of exceptionalities to specific technical requirements of the Good Manufacturing and Import Practice of Medicinal Products and Active Pharmaceutical Ingredients, due to the international public health emergency of the new coronavirus (Covid-19), was changed by the Resolution – RDC number 461, 22 January 2021. The final text is available in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/2718376/RDC_461_2021_.pdf/e999c540-64cb-4bb3-9850-1829f7b365a5

Products Covered: HS Code(s): 2941; 3003; 3004; 3005; 3006 (pharmaceutical products).

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT

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