Distribution date: 15 February 2021 | Final date for Comment: 14 May 2025

This Resolution establishes the exemption of market authorization and emergency use authorization and the procedure for the import and monitoring of Covid-19 vaccines acquired by the Ministry of Health within the scope of The Global Alliance for Vaccines and Immunization Covid-19 (Covax Facility) for the tackling the Public Health Emergency of National Concern related to the new coronavirus pandemic (SARS-CoV-2).  

Products Covered: Vaccines for human medicine (HS code(s): 300220); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

Proposed rule; request for comments - OSHA is proposing through this notice of proposed rulemaking (NPRM) to modify the Hazard Communication Standard (HCS) to conform to the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7 (GHS, Rev. 7), to address issues that arose during the implementation of the 2012 update to the HCS, and provide better alignment with other U.S. agencies and international trading partners, without lowering overall protections of the standard. OSHA has preliminarily determined that the proposed revisions to the HCS will reduce costs and burdens while also improving the quality and consistency of information provided to employers and employees regarding chemical hazards and associated protective measures. Consistent with the Executive order entitled "Improving Regulation and Regulatory Review" (18 January 2011) and section 3(a) of the Regulatory Flexibility Act, which call for assessment and, where appropriate, modification and improvement of existing rules to minimize any significant economic impact upon a substantial number of small entities, OSHA has reviewed the existing HCS. The agency has preliminarily determined that the proposed revisions will enhance the effectiveness of the HCS by ensuring employees are appropriately apprised of the chemical hazards to which they may be exposed, thus reducing the incidence of chemical-related occupational illnesses and injuries. The proposed modifications to the standard include revised criteria for classification of certain health and physical hazards, revised provisions for updating labels, new labeling provisions for small containers, technical amendments related to the contents of safety data sheets (SDSs), and related revisions to definitions of terms used in the standard.

Products Covered: Chemicals

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

The executive order implements Directive 2006/42/EC of the European Parliament and of the Council on machinery (the Machinery Directive), as amended, and European Commission Decision 2012/32/EU on requirements for member states to prohibit the placing on the market of flail-type cutting attachments for portable hand-held brush cutters.The executive order lays down requirements for retailers who place machines and partly completed machines on the market or make them available on the market. In addition, flail-type cutting attachments for portable hand-held brush cutters is prohibited.The executive order also lays down language requirements and lays down sanctions for breaches of the rules.

Products Covered: Engines and motors (excl. steam turbines, internal combustion piston engine, hydraulic turbines, water wheels, gas turbines and electric motors); parts thereof (HS code(s): 8412); Furnace burners for liquid fuel, for pulverized solid fuel or for gas; mechanical stokers, incl. their mechanical grates, mechanical ash dischargers and similar appliances; parts thereof (HS code(s): 8416); Industrial or laboratory furnaces and ovens, non-electric, incl. incinerators (excl. drying ovens and ovens for cracking operations) (HS code(s): 8417); Machinery, plant or laboratory equipment whether or not electrically heated (excl. furnaces, ovens and other equipment of heading 8514), for the treatment of materials by a process involving a change of temperature such as heating, cooking, roasting, distilling, rectifying, sterilizing, pasteurizing, steaming, drying, evaporating, vapourizing, condensing or cooling (excl. those used for domestic purposes); instantaneous or storage water heaters, non-electric; parts thereof (HS code(s): 8419); Calendering or other rolling machines (other than for metals or glass) (HS code(s): 842010); Centrifuges, incl. centrifugal dryers (excl. those for isotope separation); filtering or purifying machinery and apparatus, for liquids or gases; parts thereof (excl. artificial kidneys) (HS code(s): 8421); Pulley tackle and hoists (other than skip hoists); winches and capstans; jacks (HS code(s): 8425); Fork-lift trucks; other works trucks fitted with lifting or handling equipment (excl. straddle carriers and works trucks fitted with a crane) (HS code(s): 8427); Lifting, handling, loading or unloading machinery, e.g. lifts, escalators, conveyors, teleferics (excl. pulley tackle and hoists, winches and capstans, jacks, cranes of all kinds, mobile lifting frames and straddle carriers, works trucks fitted with a crane, fork-lift trucks and other works trucks fitted with lifting or handling equipment) (HS code(s): 8428); Self-propelled bulldozers, angledozers, graders, levellers, scrapers, mechanical shovels, excavators, shovel loaders, tamping machines and road rollers (HS code(s): 8429); Moving, grading, levelling, scraping, excavating, tamping, compacting, extracting or boring machinery, for earth, minerals or ores; pile-drivers and pile-extractors; snow-ploughs and snow-blowers (excl. those mounted on railway wagons, motor vehicle chassis or lorries, self-propelled machinery of heading 8429, lifting, handling, loading or unloading machinery of heading 8425 to 8428 and hand-operated tools) (HS code(s): 8430); Parts suitable for use solely or principally with the machinery of heading 8425 to 8430, n.e.s. (HS code(s): 8431); Harvesting or threshing machinery, incl. straw or fodder balers; grass or hay mowers; machines for cleaning, sorting or grading eggs, fruit or other agricultural produce; parts thereof (other than machines for cleaning, sorting or grading seed, grain or dried leguminous vegetables of heading 8437) (HS code(s): 8433); Milking machines and dairy machinery (excl. refrigerating or heat treatment equipment, cream separators, clarifying centrifuges, filter presses and other filtering equipment); parts thereof (HS code(s): 8434); Presses, crushers and similar machinery used in the manufacture of wine, cider, fruit juices or similar beverages (excl. machinery for the treatment of these beverages, incl. centrifuges, filter presses, other filtering equipment and domestic appliances); parts thereof (HS code(s): 8435); Agricultural, horticultural, forestry, poultry-keeping or bee-keeping machinery, incl. germination plant fitted with mechanical or thermal equipment; poultry incubators and brooders; parts thereof (HS code(s): 8436); Machines for cleaning, sorting or grading seed, grain or dried leguminous vegetables; machinery used in the milling industry or for the working of cereals or dried leguminous vegetables (excl. farm-type machinery, heat treatment equipment, centrifugal dryers and air filters); parts thereof (HS code(s): 8437); Machinery for making pulp of fibrous cellulosic material or for making or finishing paper or paperboard (excl. autoclaves, boilers, dryers, other heating appliances and calenders); parts thereof (HS code(s): 8439); Book-binding machinery, incl. book-sewing machines (excl. machinery of heading 8441, general-purpose presses, printing machinery of heading 8443 and machines of uses ancillary to printing); parts thereof (HS code(s): 8440); Machines for extruding, drawing, texturing or cutting man-made textile materials (HS code(s): 8444); Machines for preparing textile fibres; spinning, doubling or twisting machines and other machinery for producing textile yarns (excl. machines of heading 8444); textile reeling or winding, incl. weft-winding, machines, and machines for preparing textile yarns for use on the machines of heading 8446 or 8447 (HS code(s): 8445); Weaving machines "looms" (HS code(s): 8446); Knitting machines, stitch-bonding machines and machines for making gimped yarn, tulle, lace, embroidery, trimmings, braid or net and machines for tufting (excl. hem-stiching machines) (HS code(s): 8447); Machinery for the manufacture or finishing of felt or nonwovens in the piece or in shapes, incl. machinery for making felt hats; blocks for making hats; parts thereof (excl. machinery for preparing fibres for felt and calenders) (HS code(s): 8449); Machinery (excl. of heading 8450) for washing, cleaning, wringing, drying, ironing, pressing incl. fusing presses, bleaching, dyeing, dressing, finishing, coating or impregnating textile yarns, fabrics or made-up textile articles and for applying paste to the base fabric or other support used in the manufacture of floor coverings like linoleum; machines for reeling, unreeling, folding, cutting or pinking textile fabrics; parts thereof (HS code(s): 8451); Sewing machines (other than book-sewing machines of heading 8440); furniture, bases and covers specially designed for sewing machines; sewing machine needles; parts thereof (HS code(s): 8452); Machinery for preparing, tanning or working hides, skins or leather or for making or repairing footwear or other articles of hides, skins or leather (excl. drying machines, spray guns, machines for the dehairing of pigs, sewing machines and general purpose presses); parts thereof (HS code(s): 8453); Converters, ladles, ingot moulds and casting machines of a kind used in metallurgy or in metal foundries (excl. metal powder presses); parts thereof (HS code(s): 8454); Metal-rolling mills and rolls therefor; parts of metal-rolling mills (HS code(s): 8455); Machine-tools for working any material by removal of material, by laser or other light or photon beam, ultrasonic, electro-discharge, electro-chemical, electron beam, ionic-beam or plasma arc processes (excl. cleaning apparatus operated by ultrasonic processes, soldering and welding machines, incl. those which can be used for cutting, and material testing machines) (HS code(s): 8456); Machining centres, unit construction machines "single station" and multi-station transfer machines for working metal (HS code(s): 8457); Lathes, incl. turning centres, for removing metal (HS code(s): 8458); Machine-tools, incl. way-type unit head machines, for drilling, boring, milling, threading or tapping (excl. lathes and turning centres of heading 8458, gear cutting machines of heading 8461 and hand-operated machines) (HS code(s): 8459); Machine-tools for deburring, sharpening, grinding, honing, lapping, polishing or otherwise finishing metal, metal carbides or cermets by means of grinding stones, abrasives or polishing products (excl. gear cutting, gear grinding or gear finishing machines of heading 8461 and machines for working in the hand) (HS code(s): 8460); Machine-tools for planing, shaping, slotting, broaching, gear cutting, gear grinding or gear finishing, sawing, cutting-off and other machine-tools working by removing metal, sintered metal carbides or cermets, n.e.s. (HS code(s): 8461); Machine-tools, incl. presses, for working metal by forging, hammering or die-stamping; machine-tools, incl. presses, for working metal by bending, folding, straightening, flattening, shearing, punching or notching; presses for working metal or metal carbides, not specified above (HS code(s): 8462); Machine-tools for working metal, sintered metal carbides or cermets, without removing material (excl. forging, bending, folding, straightening and flattening presses, shearing machines, punching or notching machines, presses and machines for working in the hand) (HS code(s): 8463); Machine-tools for working stone, ceramics, concrete, asbestos-cement or like mineral materials or for cold-working glass (excl. machines for working in the hand) (HS code(s): 8464); Machine-tools, incl. machines for nailing, stapling, glueing or otherwise assembling, for working wood, cork, bone, hard rubber, hard plastics or similar hard materials (excl. machines for working in the hand) (HS code(s): 8465); Parts and accessories suitable for use solely or principally with the machine-tools of heading 8456 to 8465, incl. work or tool holders, self-opening dieheads, dividing heads and other special attachments for machine-tools, n.e.s.; tool holders for any type of tool for working in the hand (HS code(s): 8466); Tools for working in the hand, pneumatic, hydraulic or with self-contained electric or non-electric motor; parts thereof (HS code(s): 8467); Machinery and apparatus for soldering, brazing or welding, whether or not capable of cutting (other than those of heading 8515); gas-operated surface tempering machines and appliances; parts thereof (HS code(s): 8468); Typewriters, non-electric (HS code(s): 846930); Office machines, e.g. hectograph or stencil duplicating machines, addressing machines, automatic banknote dispensers, coin-sorting machines, coin-counting or wrapping machines, pencil-sharpening machines, perforating or stapling machines, n.e.s. (HS code(s): 8472); Machinery for sorting, screening, separating, washing, crushing, grinding, mixing or kneading earth, stone, ores or other mineral substances, in solid, incl. powder or paste, form; machinery for agglomerating, shaping or moulding solid mineral fuels, ceramic paste, unhardened cements, plastering materials or other mineral products in powder or paste form; machines for forming foundry moulds of sand; parts thereof (HS code(s): 8474); Machines for assembling electric or electronic lamps, tubes or valves or flashbulbs, in glass envelopes; machines for manufacturing or hot working glass or glassware (excl. furnaces and heating apparatus for manufacturing toughened glass); parts thereof (HS code(s): 8475); Automatic goods-vending machines, e.g. postage stamp, cigarette, food or beverage machines, incl. money-changing machines; parts thereof (HS code(s): 8476); Machinery for working rubber or plastics or for the manufacture of products from these materials, not specified or included elsewhere in this chapter, parts thereof (HS code(s): 8477); Machinery for preparing or making up tobacco, not specified or included elsewhere in this chapter; parts thereof (HS code(s): 8478); Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof (HS code(s): 8479); Parts of machinery of chapter 84, not intended for a specific purpose, n.e.s. (HS code(s): 848590); Electric motors and generators (excl. generating sets) (HS code(s): 8501); Electric generating sets and rotary converters (HS code(s): 8502); Machine tools (ICS code(s): 25.080)

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

The executive order implements parts of Directive 2013/29/EC of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of pyrotechnic articles and implements parts of Directive 2006/123/EC. The executive order lays down requirements for the import, manufacture, storage, transfer, acquisition and use of fireworks and other pyrotechnic articles in Denmark. Primarily, the executive order consists of national rules.

Products Covered: Fireworks, signalling flares, rain rockets, fog signals and other pyrotechnic articles (excl. cartridge blanks) (HS code(s): 3604); Explosives. Pyrotechnics and fireworks (ICS code(s): 71.100.30)

Regulation Type: Regular notification

Distribution date: 18 February 2021 | Final date for Comment: 19 April 2021

The executive order implements parts of Directive 2013/29/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market pyrotechnic articles and Implementing Directive 2014/58/EU setting up, pursuant to directive 2007/23/EC of the European Parliament and of the Council, a system for the traceability of pyrotechnic articles. The executive order lays down requirements for retailers who place fireworks or other pyrotechnic articles on the market or make them available on the market. In addition, the essential safety requirements for fireworks and other pyrotechnic articles is laid down, as well as requirements for the categorization and marking of fireworks and other pyrotechnic articles. The executive order also lays down requirements for the communication with the authorities and lays down penalties for breaches of the rules.

Products Covered: Fireworks, signalling flares, rain rockets, fog signals and other pyrotechnic articles (excl. cartridge blanks) (HS code(s): 3604); Explosives. Pyrotechnics and fireworks (ICS code(s): 71.100.30)

Regulation Type: Regular notification

Distribution date: 19 February 2021 | Final date for Comment: 20 April 2021

The order contains a draft of the new provisions regarding a new registration-obligation for a number of companies dealing with Commercial use of pesticides. The registration-obligation requires the Companies to inform whether they have pesticides in stock and their name, address etc. The order obliges Companies to do this yearly as a prerequisite to dealing with Commercial use of pesticides and for the to pay a small fee in connection to this.

Products Covered: Pesticides

Regulation Type: Regular notification

Distribution date: 19 February 2021 | Final date for Comment: 20 April 2021

NEA is proposing the following enhancements to the control of lead in paints: The manufacture and import of all paints, except zinc-based anti-corrosion and copper-based anti-fouling paints, with total lead concentration exceeding 90 ppm will not be allowed, unless solely for export; and Zinc-based anti-corrosion and copper-based anti-fouling paints with total lead concentration exceeding the limit of 90 ppm can only be used for industrial applications and the following label must be affixed on the paint containers, unless solely for export: “This paint contains lead. Restricted to industrial applications only. Do not use on furniture, buildings or in publicly accessible areas”. The manufacture/import of all paints with total lead concentration exceeding 90ppm for export will require a Hazardous Substance license from NEA.

Products Covered: HS heading Description 32081020 Anti-fouling or anti-corrosive paints for ships’ hulls based on polyesters in non-aqueous medium 32081090 Other paints based on polyesters in non-aqueous medium & solutions 32082040 Anti-fouling or anti-corrosive paints of acrylic or vinyl polymers in non-aqueous medium for ship hull 32082090 Other paints & varnishes in non-aqueous medium & solutions based on acrylic or vinyl polymers 32089030 Anti-fouling or anti-corrosive paints for ships’ hulls based on other polymers in non-aqueous medium 32089090 Other paints in non-aqueous medium & solutions based on other polymers 32091050 Anti-fouling or anti-corrosive paints of acrylic or vinyl polymers in aqueous medium for ships hulls 32091090 Other paints & varnishes of acrylic or vinyl polymers in aqueous medium 32099000 Other paints & varnishes of synthetic or chemically modified natural polymers in aqueous medium 32100091 Anti-fouling or anti-corrosive paints for ships hulls 32100099 Other paints & varnishes

Regulation Type: Regular notification

Distribution date: 22 February 2021 | Final date for Comment: 23 April 2021

The notified Executive Decree sets out the implementing regulations for Law No. 1 of 10 January 2001, which regulates all aspects relating to the functions of the National Pharmacy and Drugs Directorate; the charging of fees for the Directorate's services; and all aspects relating to the registration of the following pharmaceutical products: · Topical antiseptics · Bactericides and disinfectants · Biological and biotechnological products · Cosmetics · Herbal medicines · Chemically synthesized medicines · Homeopathic medicines · Orphan medicines · Pesticides for household and public health use · Household and hospital cleaning products with antiseptic and fungicidal properties · Radiopharmaceuticals · Vitamin or dietary supplements It also sets out implementing regulations for all aspects relating to the accelerated registration procedure; labelling; stability; interchangeability; manufacture, control and inspection and other provisions; marketing; prior and post- verification of pharmaceutical products; the National Pharmacovigilance System; pharmacotherapy; regulation and inspection of pharmaceutical establishments; good manufacturing practices for cosmetic, antiseptic and disinfectant products and household pesticides; registration requirements for raw materials, excipients and packaging inputs in industries producing medicines, cosmetics, disinfectants, pesticides and other products; product distribution; good pharmaceutical practices; prescriptions; and government procurement of human health products.

Products Covered: Pharmaceutical products (HS code(s): 30); Essential oils and resinoids; perfumery, cosmetic or toilet preparations (HS code(s): 33); Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up in forms or packings for retail sale or as preparations or articles (for example, sulphur-treated bands, wicks and candles, fly-papers). (HS code(s): 3808); Pharmaceutics (ICS code(s): 11.120); Pesticides and other agrochemicals (ICS code(s): 65.100); Cosmetics. Toiletries (ICS code(s): 71.100.70)

Regulation Type: Regular notification

Distribution date: 23 February 2021 | Final date for Comment: 13 March 2021

The final date for comments of the Draft Resolution number 932, 13 October 2020 – previously notified through G/TBT/N/BRA/1095 – which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was extended for 15 days.

Products Covered: 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); 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 (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 23 February 2021 | Final date for Comment: 13 March 2021

The final date for comments of the Draft Normative Instruction number 931, 13 October 2020 – previously notified through G/TBT/N/BRA/1094 – which establishes new codes for the administrative request of market authorization for new and innovative synthetic and semisynthetic medicines, was extended for 15 days.

Products Covered: 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); 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 (HS code(s): 3005); Pharmaceutical preparations and products of subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification