Regulatory Updates

Distribution date: 17 November 2021 | Final date for Comment: 16 January 2022

With a view to implementing Paragraph 3, Article 4 of the Cosmetic Hygiene and Safety Act, the Ministry of Health and Welfare promulgated Regulations for Cosmetic Product Information File Management (hereinafter ''the Regulations''), which specify the requirements for product information files to be established by manufacturers or importers prior to the supply, sale, giveaway, public display or consumer trial offer of cosmetics. The content included the applicable scope of manufacturers or importers, the information to be included in the product information files, the qualifications of signatories for the safety reports, storage period of the product information files. There were suggestions on the qualifications of signatories for the safety reports received. After evaluation of those suggestions, the Ministry of Health and Welfare is proposing to regulate that a person who graduated from the department of chemistry and chemical engineering at the domestic or foreign university before 30 June 2019, and had at least five years of relevant work experience in cosmetic safety evaluation, may keep engaging in relevant work and thus serve as a signatory for the safety report. Therefore, the amendments to Article 4 of the Regulations is proposed to be adopted.

Products Covered: ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Lauric Acid is a saturated fatty acid having 12 carbon atoms. It is a raw material for making Lauryl Alcohol, which is used in detergent industry. It is also used in Alkyd resins, Lauryl peroxides, ethanol amides etc. It is obtained by splitting coconut oils, Palm Kernel Oil etc. The large quantity usage and imports of Fatty Acids and possible health impact of low purity. So, for protection of human health and environment, the standard of Lauric Acid needs to be made mandatory. The locally manufactured or imported Lauric Acid shall conform to the Indian standard (IS 10931:1984) 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: Lauric Acid (HS Code 29159090)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Rubberseed Fatty Acids are produced by hydrolysis of Rubber seed Oil.  Rubber seed oil is obtained from seed kernels of  Rubber trees. Rubber Seed Fatty Acids contain Linolenic Acis (30-40%), Oleic Acid (17-30%)  and   Linoleic Acid (22-24%) and other saturated fatty Acids  like Palmitic acid and Stearic Acids. These fatty acids are used in the manufacture of Soap industry and also in Paints/varnish industry. The large quantity usage and imports of Fatty acids and possible health impact of low purity. So, for protection of human health and environment, the standard of Rubberseed Fatty Acids needs to be made mandatory. The locally manufactured or imported Rubberseed Fatty Acids shall conform to the Indian standard (IS 12124:1987) 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: Rubberseed Fatty Acids (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Rice Bran Fatty Acids are produced by the hydrolysis of Rice Bran Oil.  Rice Bran Oil is produced by solvent extraction of the layer around the endosperm of rice, known as Rice Bran . Rice Bran  Fatty Acid contains 20-25% of saturated and 75-80% of unsaturated fatty acids. The main unsaturated fatty acids are Oleic Acids (40-50%) and Linolenic Acids (28-42%). These fatty acids are used in the manufacture of soaps. The large quantity usage and imports of Fatty acids and possible health impact of low purity. So, for the protection of human health and the environment, the standard of Rice Bran Fatty Acids needs to be made mandatory. The locally manufactured or imported Rice Bran Fatty Acids shall conform to the Indian standard (IS 12068:1987) 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 the standard marks is governed by the provisions of the 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: Bran Fatty Acids (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Hydrogenated Rice Bran Fatty Acids is obtained by splitting, distillation and hydrogenation of rice bran oil or by hydrogenation of distilled fatty acids obtained by splitting of rice bran oil. Rice Bran Fatty acids are used in the manufacture of soaps. The large quantity usage and imports of Fatty acids and possible health impact of low purity. So, for the protection of human health and the environment, the standard of Hydrogenated Rice Bran Fatty Acids needs to be made mandatory. The locally manufactured or imported Hydrogenated Rice Bran Fatty Acids shall conform to the Indian standard (IS 12361:1988) 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 the standard mark is governed by the provisions of the 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: Hydrogenated Rice Bran Fatty Acids (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Palm Fatty Acids are obtained by hydrolysis of Palm Oils.  Palm Oils is obtained from the fleshy part of Palm Fruits. Palm Fatty  Acids consist of saturated and unsaturated fatty acids in equal amounts, Palmitic Acid and Oleic Acids are being the main fatty acids. Palm Fatty Acids are used in the soap industry. The large quantity usage and imports of Fatty Acids and the possible health impact of low purity. So, for the protection of human health and the environment, the standard of Palm Fatty Acids needs to be made mandatory. The locally manufactured or imported Palm Fatty Acid shall conform to the Indian standard (IS 12067:1987) 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 the standard mark is governed by the provisions of the 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: Fatty Acids (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 16 November 2021 | Final date for Comment: 15 January 2022

Coconut Fatty Acids are produced by the hydrolysis of Coconut Oil. Coconut Fatty Acids comprise of about 90% saturated fatty acids. The main fatty acids are Lauric Acid, which constitutes about 50% of total fatty acids obtained from coconut oil. Coconut Fatty Acids are used in the manufacture of Soaps and their derivatives like coco diethanol amide and coco mono ethanolamide. The large quantity usage and imports of Fatty acids and possible health impact of low purity. So, for protection of human health and environment, the standard of Coconut Fatty Acids needs to be made mandatory. The locally manufactured or imported Coconut Fatty Acids shall conform to the Indian standard (IS 12069:1987) 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 the standard marks is governed by the provisions of the 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: Coconut Fatty Acids (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 15 November 2021 | Final date for Comment: 14 January 2022

 Acid Oil is produced by acidification of soap stock obtained during refining of oils. It is used for producing low grade soaps. The large quantity usage and imports of Fatty acids and possible health impact of low purity. So, for protection of human health and environment, the standard of Acid Oil needs to be made mandatory. The locally manufactured or imported Acid Oil shall conform to the Indian standard (IS 12029:1986) 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: Acid Oil (HS Code 38231900)

Regulation Type: Regular notification

Distribution date: 15 November 2021 | Final date for Comment: 14 January 2022

1,3 Phenylenediamine  is an important dye-intermediate, polymer additive, fibre intermediate and used in photography. Since it is used in dyestuffs required for dyeing of textiles, it is very important to adhere to purity levels indicated in the standard. The excess impurities in the dyes may enter human chain through textiles, impacting the health.If the technical parameters indicated in the standard are not observed, it shall be detrimental to plant life and environment. So, for protection of human health and environment, the standard of 1,3 Phenylenediamine needs to be made mandatory.  The locally manufactured or imported 1,3 Phenylenediamine  shall conform to the Indian standard (IS 17450:2020) 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: 1,3 Phenylenediamine (HS Code 2921 5120)

Regulation Type: Regular notification

Distribution date: 12 November 2021

The Draft Normative Instruction number 85, 26 March 2021 – previously notified through G/TBT/N/BRA/1068/Add.1, which establishes technical requirements for medical devices selected to economic monitoring, by Anvisa, was adopted as Normative Instruction number 105, 03 November 2021. The final text is available only in Portuguese and can be downloaded at: https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=03/11/2021&jornal=515&pagina=77&totalArquivos=190

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent. (HS code(s): 2936); Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones. (HS code(s): 2937); Pharmaceutical products (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification