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

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

This Draft East African Standard specifies requirements, sampling and test methods for medical cotton swabs. This standard does not apply to flocked swabs for clinical use.

Products Covered: (HS code(s): 300590); Surgical instruments and materials (ICS code(s): 11.040.30)

Regulation Type: Regular notification

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

This Draft East African Standard specifies requirements, sampling and test methods for cotton ear buds.

Products Covered: Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (excl. adhesive dressings and other articles having an adhesive layer) (HS code(s): 300590); Medical sciences and health care facilities in general (ICS code(s): 11.020)

Regulation Type: Regular notification

Distribution date: 17 November 2021 | Final date for Comment: 08 May 2025

The purpose of this Notice of Intent to Amend is to notify that, as a result of a scientific review and public consultation, Health Canada will add a qualifier to brimonidine on the Prescription Drug List to enable sale of certain non-prescription products. Both the human and veterinary parts of the Prescription Drug List are to be revised. Health Canada has conducted a scientific review of brimonidine tartrate against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations that led to this decision. The wording of the qualifier has not changed from that was proposed in the 1 September 2021 Notice of Consultation, notified under G/TBT/N/CAN/653. This revision will be in effect six months from the date that the Notice of Intent to Amend is posted on the Health Canada website.

Products Covered: Prescription status of medicinal ingredients for human and veterinary use (ICS: 11.120.01; HS: 3004.90)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 November 2021 | Final date for Comment: 08 May 2025

National Institute of Metrology, Quality and Technology - Inmetro, issued the following Ordinance no. 456, 16 November 2021 that approves the consolidation of conformity assessment requirements of hydraulic brakes for motor vehicles.The aim of the consolidation of the regulation is to attend decree no. 10.139 of 28 November 2020.Inmetro Ordinance No. 456 revokes the following act on the effective date of adoption:-       Ordinance Inmetro no. 78, of 3 February 2011, published in the Official Gazette of 7 February 2011, section 1, page 95, previously notified through G/TBT/N/BRA/400/Add.1.

Products Covered: Hydraulic brake fluids for automotive vehicles (HS 381900)

Regulation Type: Addendum to Regular Notification

Distribution date: 19 November 2021 | Final date for Comment: 08 May 2025

Inmetro Ordinance No. 455 consolidates metrological technical regulation establishing the conditions for pre-packaged soap and bar soap goods

Products Covered: Soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS code(s): 3401); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 22 November 2021 | Final date for Comment: 21 January 2022

The draft Ordinance contains adaptations of existing and new regulations in the Chemical Risk Reduction Ordinance (ORRChem) in the areas of persistent organic pollutants (Annex 1.1), halogenated organic substances (Annex 1.2), substances that deplete the ozone layer (Annexes 1.4 and 2.9), substances stable in the atmosphere (Annexes 1.5 and 2.10), asbestos (Annex 1.6), carcinogenic, mutagenic and reprotoxic substances (Annex 1.10), per- and polyfluoroalkyl substances (PFOS, PFOA, C9-C14 PFCA, PFHxS; Annexes 1.16 and 2.11), oxo-degradable plastics (Annex 2.9), and polycyclic aromatic hydrocarbons (PAH; Annex 2.9). The existing prohibition for the placing on the market of wood, textiles and leather goods containing pentachlorophenol (PCP), its salts and esters will be extended to any other products containing PCP, its salts and esters. The placing on the market of substances that are stable in the atmosphere will, for specific uses, be allowed in refillable containers only. Labeling requirements will be updated to specify containers with reclaimed or recycled substances. Medical devices will be exempted from the ban on supply to the general public of substances with carcinogenic, mutagenic, or reprotoxic properties (CMR-substances), and mixtures that contain such substances. Existing exemptions from the prohibition of the placing on the market and use of PFOS and PFOS-related substances as well as preparations and articles containing these substances are repealed (photoresists or anti-reflective coatings for photolithography processes; photographic coatings applied to films, papers, or printing plates) or time limited (mist suppressants for non-decorative hard chromium (VI) plating in closed loop systems). The manufacture, placing on the market and use of PFHxS and related substances, as well as mixtures and articles containing such substances, will be prohibited. Existing restrictions for PFOA and its precursors are extended to longer-chain perfluorocarboxylic acids (C9-C14 PFCA) and their precursors as well as mixtures and articles containing such substances. The placing on the market and use of granules and mulches used as infill material in synthetic turf pitches or in loose form on playgrounds or in sport applications will be prohibited if they contain more than 20 mg/kg of the sum of eight listed PAH. The placing on the market and use of plastic products containing additives that cause the plastic to break down into fragments (oxo-degradable plastics) will be prohibited. Existing reporting requirements for stationary systems containing refrigerants will be extended with information requirements specific to heat pumps. The placing on the market of temporary ice-rinks containing a refrigerant with a global warming potential higher than 4000 will be prohibited. A new exemption will be introduced for the manufacture and placing on the market of foams containing substances with an ozone depletion potential smaller than 0.0005, as well as for the manufacture and placing on the market of articles containing such foams.  

Products Covered: Pentachlorophenol (PCP, CAS RN 87-86-5), its salts and esters. Perfluorooctane sulfonic acid and its derivatives (PFOS) as a substance on its own and as a constituent of other substances, in mixtures, or in articles or any part thereof. This include substances with the following CAS RNs: 1763-23-1, 2795-39-3, 29457-72-5, 29081-56-9, 70225-14-8, 56773-42-3, 251099-16-8, 4151-50-2, 31506-32-8, 1691-99-2, 24448-09-7, 307-35-7, and others. Perfluorooctanoic acid (PFOA), CAS RN 335-67-1, its salts and PFOA-related substances as a substance on its own and as a constituent of other substances, in mixtures, or in articles or any part thereof. Perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCA), their salts and related substances as a substance on its own and as a constituent of other substances, in mixtures, or in articles or any part thereof. The term "C9-C14 PFCAs" is used as an abbreviation for: Perfluorononan-1-oic acid (C9-PFCA), CAS RN 375-95-1; Nonadecafluorodecanoic acid (C10-PFCA), CAS RN 335-76-2; Henicosafluoroundecanoic acid (C11-PFCA), CAS RN 2058-94-8; Tricosafluorododecanoic acid (C12-PFCA), CAS RN 307-55-1; Pentacosafluorotridecanoic acid (C13-PFCA), CAS RN 72629-94-8; Heptacosafluorotetradecanoic acid (C14-PFCA), CAS RN 376-06-7; C9-C14 PFCA related substances can be transformed in the environment to C9-C14 PFCA. Perfluorohexane sulfonic acid (PFHxS), CAS RN 355-46-4, its salts and PFHxS-related substances as a substance on its own and as a constituent of other substances, in mixtures, or in articles or any part thereof. Polycyclic aromatic hydrocarbons (PAH) in granules or mulches used as infill materials in synthetic turf pitches or in loose form on playgrounds or in sport applications. PAH is used as abbreviation for eight carcinogenic substances: Benzo[a]pyrene (BaP), CAS RN 50-32-8; Benzo[e]pyrene, CAS RN 192-97-2; Benzo[a]anthracene, CAS RN 56-55-3; Chrysen, CAS No 218-01-9; Benzo[b]fluoranthene, CAS No 205-99-2; Benzo[j]fluoranthene, CAS No 205-82-3; Benzo[k]fluoranthene, CAS No 207-08-9; Dibenzo[a,h]fluoranthene, CAS No 53-70-3. Appliances and equipment with asbestos-containing components. Substances stable in the atmosphere. Foams and articles with foams containing ozone-depleting substances.

Regulation Type: Regular notification

Distribution date: 22 November 2021 | Final date for Comment: 21 January 2022

This Draft East African Standard specifies requirements, sampling and test methods for duvets

Products Covered: Duvets, Quilts, Comforters

Regulation Type: Regular notification