DRAFT LAW N° …….……….. OF ………..……. GOVERNING THE EXPORTATION OF AGRICULTURAL PRODUCTS

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Distribution date: 22 February 2023 | Final date for Comment: 03 May 2025

This Law applies to activities related to export or re-export of agricultural products; and value chain management of agricultural products.

Products Covered: LIVE ANIMALS (HS code(s): 01)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); PRODUCTS OF ANIMAL ORIGIN, NOT ELSEWHERE SPECIFIED OR INCLUDED (HS code(s): 05); LIVE TREES AND OTHER PLANTS; BULBS, ROOTS AND THE LIKE; CUT FLOWERS AND ORNAMENTAL FOLIAGE (HS code(s): 06); 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); LAC; GUMS, RESINS AND OTHER VEGETABLE SAPS AND EXTRACTS (HS code(s): 13); 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); 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); RESIDUES AND WASTE FROM THE FOOD INDUSTRIES; PREPARED ANIMAL FODDER (HS code(s): 23); ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Regulations governing licensing of public and private manufacturers,distributors, wholesalers and retailers of medical Products

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

These Regulations enforce the legal framework for application, inspection, storage, distribution, andlicensing of public and private manufacturers, distributors, wholesalers and retailers of MedicalProducts. These Regulations apply to public, and private manufacturers, distributors, wholesalers and retailersof medical products involved in the manufacture, storage, sale, distribution, and dispensing ofmedical products.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

Regulations, No.: DFAR/HMDAR/TRG/002 Rev_2,  Governing Registration of Medical Devices including In Vitro Diagnostics

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

The purpose of these regulations is to enforce the legal framework to ensure effective and efficient registration of human and veterinary Medical Devices including In Vitro Diagnostics, and to provide an open, transparent and non-discriminatory process for the registration of Medical Devices including In Vitro Diagnostics.

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 (HS code(s): 3005); - Other : (HS code(s): 30069)

Regulation Type: Regular notification

Human health

Regulations, No.: FDISM/FDIEC/TRG/001 Rev_2, Governing Control of Importation and Exportation of Pharmaceutical Products and Medical Devices

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Distribution date: 22 February 2023 | Final date for Comment: 23 April 2023

The purpose of these Regulations is to provide a legal framework for the effective and efficient control of importation and exportation of pharmaceutical products, medical devices, and their respective raw materials in a transparent, non-discriminatory manner.

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Regulations No.: CBD/TRG/017 Rev_1 Governing Promotion, Advertisement and Marketing of regulated products

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Distribution date: 23 February 2023 | Final date for Comment: 24 April 2023

These regulations shall apply to all activities related to the advertisements or promotion and marketing of regulated products that are manufactured, imported, distributed, stored, sold or used in Rwanda.  

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

The following communication, received on 22 February 2023, is being circulated at the request of the delegation of Morocco.

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Distribution date: 24 February 2023 | Final date for Comment: 03 May 2025

Physical and chemical specifications for couscous and pasta Order No. 3092-22 of the Minister of Agriculture, Marine Fisheries, Rural Development, Water Resources and Forestry of 14 November 2022[ https://www.onssa.gov.ma/wp-content/uploads/2023/01/ARR.3092-22.FR_.pdf ], establishing physical and chemical specifications for couscous and pasta, was published in Official Journal No. 7158 of 5 January 2023. NB: This Order revokes Order No. 250596 of the Minister of Agriculture and Agricultural Development of 9 Chaabane 1417 (20 December 1996) on the manufacture and marketing of pasta and couscous. https://www.onssa.gov.ma/reglementation-sectorielle-produits-alimentaires-2/ https://members.wto.org/crnattachments/2023/SPS/MAR/23_1288_00_f.pdf

Products Covered: Couscous et pâtes alimentaires

Regulation Type: Addendum to Regular Notification

Human health Food safety Adoption/publication/entry into force of reg.

Regulations No. FDISM/FDIC/TRG/005 Governing Good Manufacturing Practices for Medical Products

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Distribution date: 24 February 2023 | Final date for Comment: 25 April 2023

These regulations shall apply to GMP inspections of active pharmaceutical ingredients and finished pharmaceutical products sites that manufacture, import, export, distribute, store, sell, and that are used within and outside Rwanda for medical products.  

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Human health

Filing of Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs; Petition for Rulemaking

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Distribution date: 24 February 2023 | Final date for Comment: 18 April 2023

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Center for Science in the Public Interest, et al., proposing that FDA repeal the color additive regulations providing for the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs.

Products Covered: Inorganic or mineral colouring matter, n.e.s.; preparations based on inorganic or mineral colouring matter of a kind used for colouring any material or produce colorant preparations (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215); inorganic products of a kind used as luminophores, whether or not chemically defined (HS code(s): 3206); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Human health Food safety Food additives

Draft Commission Implementing Regulation approving sulfur dioxide released from sodium metabisulfite as an active substance for use in biocidal products of product-type 9 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (3 pages, in English), (Annex 2 pages, in English)  

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Distribution date: 27 February 2023 | Final date for Comment: 28 April 2023

This draft Commission Implementing Regulation approves sulfur dioxide released from sodium metabisulfite as an active substance for use in biocidal products of product-type 9

Products Covered: Biocidal products

Regulation Type: Regular notification

Proposal for a Regulation of the European Parliament and of the Council on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repealing Directive 94/62/EC (COM(2022) 677 final) (118 page, in English), (Annex - 36 page, in English)

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Distribution date: 27 February 2023 | Final date for Comment: 28 May 2023

This draft Regulation of the European Parliament and of the Council on packaging and packaging waste aims to harmonise the rules for placing packaging on the EU market while fostering packaging sustainability and circularity. It lays down sustainability requirements for placing packaging on the EU market related to its composition, design with the view to packaging minimisation, recyclability, use of secondary raw materials in plastic packaging, compostability and requirements on reusable packaging. In order to reduce the generation of packaging waste, it restricts the use of some packaging formats and establishes obligations on economic operators and Member States, including packaging reuse and waste prevention targets. As regards recycling targets and the related rules on their calculation, it maintains obligations from the existing EU packaging legislation (European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste).  

Products Covered: 3923 Articles for the conveyance or packing of goods, of plastics; stoppers, lids, caps and other closures, of plastics, 4819 packaging made of paper and cardboard, 7010 Carboys, bottles, flasks, jars, pots, phials, ampoules and other containers, of glass, of a kind used for the conveyance or packing of goods, preserving jars, stoppers, lids and other closures, of glass, 4415 Packing cases, boxes, crates, drums and similar packing of wood; cable-drums of wood; pallets, box pallets and other load boards, of wood; pallet collars of wood, 6305 Sacks and bags, of a kind used for the packing of goods, of all types of textile materials8309 Stoppers, caps and lids, incl. crown corks, screw caps and pouring stoppers, capsules for bottles, threaded bungs, bung covers, seals and other packing accessories4416 Casks, barrels, vats, tubs and other coopers’ products and parts thereof, of wood, including stavesEx 6909 Ceramic wares for laboratory, chemical or other technical uses; ceramic troughs, tubs and similar receptacles of a kind used in agriculture; ceramic pots, jars and similar articles of a kind used for the conveyance or packaging of goods7310 Tanks, casks, drums, cans, boxes and similar containers, for any material (other than compressed or liquefied gas), of iron or steel, of a capacity not exceeding 300 l, whether or not lined or heat-insulated, but not fitted with mechanical or thermal equipment 7311 Containers for compressed or liquefied gas, of iron or steel7612 Aluminium casks, drums, cans, boxes and similar containers (including rigid or collapsible tubular containers), for any material (other than compressed or liquefied gas), of a capacity not exceeding 300 litres, whether or not lined or heat-insulated, but not fitted with mechanical or thermal equipment7613 Aluminium containers for compressed or liquefied gas According to the Explanatory Notes of the Harmonized System of the WCO, reservoirs, vats, drums and similar containers, not fitted with mechanical or thermal equipment are included in the following headings as well:Ex 7419 Other articles of copperEx 7508 Other articles of nickelEx 7907 Other articles of zincEx 8007 Other articles of tinEx 8104 Magnesium and articles thereof, including waste and scrap Ex 3919, Ex 3920, Ex 3921 – wrappings if made of plasticsEx 4804, Ex 4805, Ex 4808, Ex 4813, Ex 4823 – wrappings if made of paper6306 12 and 6306 19 – tarpaulins 

Regulation Type: Regular notification

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