Distribution date: 12 October 2023

In the notification No G/TBT/N/IND/304. dated 13 September 2023, the Column no. 6 may be replaced as below: Calcined alumina is used in the manufacture of high-grade ceramic shapes, refractories and fused alumina abrasives. It is also has variety of industrial applications including Structural ceramics, Technical ceramics, Polishing compounds for plastic, metal, and glass, Fillers for Rubber and Plastics, Friction – anti slip, Refractories, Paint & Coatings and Thermal Spray Powders. So, for protection of human health and environment, the BIS standard of Calcined alumina needs to be made mandatory. The locally manufactured or imported Alumina Calcined shall conform to the Indian Standard IS 17441 (Part 1) : 2021, and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Alumina Calcined (HS CODE – 28182010)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

In the notification No G/TBT/N/IND/302. dated 13 September 2023, the Column no. 6 may be replaced as below: Sodium cyanide finds extensive use in the extraction of gold and silver from ores, in ore floatation process, pharmaceuticals and complexing agents, synthesis of intermediate compounds for preparation of hydrocyanic acid, heat treatment salts, preparation of metallic salts, etc, This is also used as insecticides/weedicides; in the preparation of cyanuric chloride, cleaning of metals, as fumigant and in the manufacture of dyes and pigments and nylon intermediate. So, for protection of human health and environment, the BIS standard of Sodium cyanide needs to be made mandatory. The locally manufactured or imported Sodium cyanide shall conform to the Indian Standard IS 11782: 1986 (Reaffirmed 2020), and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Sodium Cyanide (HS CODE 28371100)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

In the notification G/TBT/N/IND/298. dated 13 September 2023, Item 6 should read: Ethylene oxide is used in organic synthesis, especially in the production of ethylene glycol. It forms starting material for the manufacture of acrylonitrile and non-ionic surfactants. It is also used as a fumigant for foodstuffs and in textiles and pharmaceutical industry. So, for protection of human health and environment, the BIS standard of Ethylene oxide needs to be made mandatory. The locally manufactured or imported Ethylene Oxide shall conform to the Indian Standard (IS 5573: 1984) and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Ethylene Oxide (HS CODE – 29101000)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 12 October 2023

In the notification No G/TBT/N/IND/303. dated 13 September 2023, the Column no. 6 may be replaced as below: Toluene diisocyanate is used as a chemical intermediate in the production of polyurethane foams, elastomers, and coatings; paints; varnishes; wire enamels; sealants; adhesives; and binders. It is also used as a cross-linking agent in the manufacture of nylon polymers. So, for protection of human health and environment, the BIS standard of Toluene diisocyanate needs to be made mandatory. The locally manufactured or imported Toluene diisocyanate shall conform to the Indian Standard IS 17916 : 2022, and shall bear the standard mark under license from the Bureau of Indian Standards (BIS) as per Scheme-I of Schedule-II of the Bureau of Indian Standards (Conformity Assessment) Regulations, 2018. The use of standard mark is governed by the provisions of Bureau of Indian Standards Act, 2016 and the Rules and Regulations made thereunder. Bureau of Indian Standards shall be the certifying and enforcing authority.

Products Covered: Toluene Diisocyanate (HS CODE – 29291020)

Regulation Type: Corrigendum to Regular Notification

Distribution date: 10 October 2023 | Final date for Comment: 09 December 2023

This Gulf Standard is concerned with air-drying gloss, semi-gloss and matt paints for use on primed or unprimed interior and exterior wood, metal, or masonry surfaces.

Products Covered: All product fall under scope of "Paints and Varnishes – Gloss, Semi-Gloss and Matt Alkyd Enamel Paint for Interior and Exterior Surfaces." ( ICS 87.040 ) Paints and varnishes

Regulation Type: Regular notification

Distribution date: 10 October 2023 | Final date for Comment: 09 December 2023

The Swiss ordinance is adjusted to the Commission Regulation (EU) 2020/2081 of 14 December 2020 amending Annex XVII to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up.All further modification in the Swiss Ordinance "Ordonnance du DFI sur les objets destinés à entrer en contact avec les muqueuses, la peau ou le système pileux et capillaire, et sur les bougies, les allumettes, les briquets et les articles de farces et attrapes" are clarifications on how to apply the regulation for certain products. Furthermore the technical testing instructions and methods are updated.

Products Covered: Tattoo inks and permanent make-up 

Regulation Type: Regular notification

Distribution date: 10 October 2023 | Final date for Comment: 09 December 2023

This draft Circular issues the list of chemicals and insecticidal and disinfectant products for household and medical use which are under the state management of the Ministry of Health and whose HS codes can be indentified according to Vietnam’s nomenclature of exports and imports issued together with Circular No. 31/2022/TT-BTC dated June 8, 2022 of the Minister of Finance promulgating the List of Vietnam's export and import goods.

Products Covered: 380861, 380862, 380864, 380891, 380892

Regulation Type: Regular notification

Distribution date: 04 October 2023 | Final date for Comment: 03 December 2023

The Ministry of Food and Drug Safety (MFDS) is proposing to amend the “Regulation for Pharmaceutical Approvals, Notifications and Reviews” as follows:A It will be allowed to use food raw materials in enteric nutritional supplements (Article 3 of the Draft)B. Expansion of the scope of minor changes that do not require approval (Article 3-2 of the Draft)C. Clarification of exemption from submission requirement of Certificate of Pharmaceutical Product (CPP), deletion of CPP for Common Technical Documents submission requirements (Articles 4, 6, and Annex 3 of the Draft)D. Clarification of approval review data requirements for synthetic peptide drug products (synthetic peptide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid(rDNA) origin(peptide of rDNA origin) (Articles 7, 27, and Appendix 1 of the Draft) E. Exemption from submission of genotoxicity test data if there is no change in the manufacturing process as a drug product already used in Korea (Article 7 of the Draft)F. Acceptance of non-clinical data which utilized appropriate non-clinical data and alternative method instead of animal test as a result of on-site inspection for OECD member countries (Article 7 of the Draft)G. Expansion of the scope of Science Citation Index (SCI) into Science Citation Index Expanded (SCIE) (Articles 7 and 14 of the Draft)H. Establishment of submission standards details for ‘Overview of Risk Management Plan’ (newly established in Article 7-2 of the Draft and Annex 6-3)I. Expansion of the scope of recognition of multiple specifications for active pharmaceutical ingredients (API) of pharmaceuticals (Article 12 of the Draft)J. Embodying description method of pharmaceuticals (Article 13 of the Draft)K. Application to MedDRA to specify precautionary information (Article 17 of the Draft)L. Update of safety and efficacy review standards for injections, ophthalmic solutions, and otic solutions(Articles 25 and 27 of the Draft)M. If a bioequivalence test is not possible or meaningless, it can be replaced with a scientifically valid test (Article 27 of the Draft)N. Update of standards for conducting bioequivalence tests for oral anticancer drugs, etc. (Article 27 of the Draft)O. Exemption from stability data in case of contract manufacture of entire process using the same manufacturing method (Article 28 of the Draft)P. Clarification of documents to be submitted for preliminary review (Newly established in Article 55 of the Draft and Annex 20)Q. Addition of National Essential Medicine (NEM) to expedited review categories (Article 58 of the Draft)

Products Covered:  Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 04 October 2023

The proposed Amendments of standards and specifications of Formic acid and establishment its standards and specifications notified in G/SPS/N/JPN/1198 (dated 24 April 2023) has been adopted and published on 26 September 2023.

Products Covered: Formic acid as a feed additive

Regulation Type: Addendum to Regular Notification

Distribution date: 02 October 2023 | Final date for Comment: 01 December 2023

Medicinal cannabis products supplied in New Zealand are required to meet the labelling requirements outlined in regulation 19 of the Misuse of Drugs (Medicinal Cannabis) Regulations 2019. The Ministry of Health is proposing a technical amendment to regulation 19 to add a reference to the requirement for medicinal cannabis products to display a controlled drug classification statement on the label to align with the labelling of all other controlled drugs supplied as medicines in New Zealand. This requirement is already in place and enforced under the Misuse of Drugs Regulations 1977. The proposed change is a clarifying amendment and not a substantive change in regulation. The technical amendment will reflect the existing guidance issued in Section 3.2.2. of the ‘Guideline on the regulation of medicinal cannabis in New Zealand: Part 3’ and the ‘Guideline on the Regulation of Therapeutic Products in New Zealand Part 5’ Section 2.2 and Figure A. 

Products Covered: Medicinal cannabis, including products under HS Chapter 12 and 29.

Regulation Type: Regular notification