Regulatory Updates

Distribution date: 23 November 2021 | Final date for Comment: 31 December 2021

Eight substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); ORGANIC CHEMICALS (HS code(s): 29); MISCELLANEOUS CHEMICAL PRODUCTS (HS code(s): 38); CHEMICAL TECHNOLOGY (ICS code(s): 71)

Regulation Type: Regular notification

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

Polyvinylchlioride (hereinafter referred to as ''PVC'') has been widely used and deeply involved in our daily lives for years. PVC products are often added with stabilizers due to the need for heat resistance substances which contain heavy metals that are harmful to human health. PVC materials are not resistant to oil-soluble corrosion; therefore, it is possible to have plasticizer contamination in our foods, resulting in environmental hormone effects and carcinogenic risk due to the exposure to PVC. Furthermore, the combustion of PVC generates not only dioxin but also lead, cadmium, and other heavy metals originated from the stabilizers in PVC. The generated dioxin and heavy metals are discharged from the incinerator chimney into the atmosphere. Furthermore, large amounts of which remains in the ash and slag inside the incinerator. Further risks to the environment are followed by the burial and reusing process of the ash and slag, which causes the pollution to be distributed in the environment. Considering the fact that Dioxin is very difficult to decompose in natural environment, negative impacts of dioxin on human health and the environment will become significant once it has entered the food chain. In order to protect the health of the citizens and environment, the Environmental Protection Administration (EPA) guides the industry to switch to other alternative materials to reduce the use of products containing PVC by the consumers. "The restriction on the production, importation, and sales of plate packaging materials containing Polyvinylchloride (PVC), designated recyclable containers, and non-plate disposable tableware containers" was drafted in accordance with Article 21 of the Waste Disposal Act and it is outlined as follows: Terminology in this announcement. The restricted subjects of this announcement are limited to those who use plate packaging materials containing Polyvinylchloride (PVC), announced recyclable containers, and non-plate disposable tableware containers. The restriction approaches and exclusions of this announcement. The recognition methods of the timing of production and importation.

Products Covered: MEAT AND EDIBLE MEAT OFFAL (HS code(s): 02); FISH AND CRUSTACEANS, MOLLUSCS AND OTHER AQUATIC INVERTEBRATES (HS code(s): 03); DAIRY PRODUCE; BIRDS' EGGS; NATURAL HONEY; EDIBLE PRODUCTS OF ANIMAL ORIGIN, NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 04); EDIBLE VEGETABLES AND CERTAIN ROOTS AND TUBERS (HS code(s): 07); EDIBLE FRUIT AND NUTS; PEEL OF CITRUS FRUIT OR MELONS (HS code(s): 08); COFFEE, TEA, MATÉ AND SPICES (HS code(s): 09); CEREALS (HS code(s): 10); PRODUCTS OF THE MILLING INDUSTRY; MALT; STARCHES; INULIN; WHEAT GLUTEN (HS code(s): 11); OIL SEEDS AND OLEAGINOUS FRUITS; MISCELLANEOUS GRAINS, SEEDS AND FRUIT; INDUSTRIAL OR MEDICINAL PLANTS; STRAW AND FODDER (HS code(s): 12); VEGETABLE PLAITING MATERIALS; VEGETABLE PRODUCTS NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 14); ANIMAL OR VEGETABLE FATS AND OILS AND THEIR CLEAVAGE PRODUCTS; PREPARED EDIBLE FATS; ANIMAL OR VEGETABLE WAXES (HS code(s): 15); PREPARATIONS OF MEAT, OF FISH OR OF CRUSTACEANS, MOLLUSCS OR OTHER AQUATIC INVERTEBRATES (HS code(s): 16); SUGARS AND SUGAR CONFECTIONERY (HS code(s): 17); COCOA AND COCOA PREPARATIONS (HS code(s): 18); PREPARATIONS OF CEREALS, FLOUR, STARCH OR MILK; PASTRYCOOKS' PRODUCTS (HS code(s): 19); PREPARATIONS OF VEGETABLES, FRUIT, NUTS OR OTHER PARTS OF PLANTS (HS code(s): 20); MISCELLANEOUS EDIBLE PREPARATIONS (HS code(s): 21); BEVERAGES, SPIRITS AND VINEGAR (HS code(s): 22); Salts, incl. table salt and denatured salt, and pure sodium chloride, whether or not in aqueous solution or containing added anti-caking or free-flowing agents; sea water (HS code(s): 2501); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those for transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); PLASTICS AND ARTICLES THEREOF (HS code(s): 39); Manufacturing processes in the rubber and plastics industries (ICS code(s): 83.020); Raw materials for rubber and plastics in general (ICS code(s): 83.040.01); Auxiliary materials and additives for plastics (ICS code(s): 83.040.30); Plastics (ICS code(s): 83.080); Rubber and plastics products in general (ICS code(s): 83.140.01); Other rubber and plastics products (ICS code(s): 83.140.99)

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

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

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

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

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: 19 November 2021

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: 19 November 2021

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: 17 November 2021

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