Draft Resolution number 889, 24 July 2020. 

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Distribution date: 22 May 2024 | Final date for Comment: 22 April 2025

Draft Resolution number 889, 24 July 2020 - previously notified through G/TBT/N/BRA/1056 - which establishes technical requirements for the notification, market authorization, and post market authorization for medicinal gases, was adopted as Normative Instruction 301, 17 May 2024  The final text is available only in Portuguese and can be downloaded at:  https://antigo.anvisa.gov.br/documents/10181/3428523/IN_301_2024_.pdf/c49403d9-30b3-4716-ad93-51dd514c34be 

Products Covered: Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or informs or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading No. 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale. (HS code(s): 3004); Wadding, gauze, bandages and similar articles (for example, dressings, adhesive plasters, poultices), impregnated or coated with pharmaceutical substances or put up in forms or packings for retail sale for medical, surgical, dental or veterinary purposes. (HS code(s): 3005); Pharmaceutical goods specified in Note 3 to this Chapter. (HS code(s): 3006); Anaesthetic, respiratory and reanimation equipment (ICS code(s): 11.040.10)

Regulation Type: Addendum to Regular Notification

Human health

National Standard of the P.R.C., Feed Additives — Part 4: Enzymes —α-galactosidase

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Distribution date: 22 May 2024 | Final date for Comment: 21 July 2024

This document specifies the terms and definitions, technical requirements, test methods, inspection rules, labeling, packaging, transportation, storage and shelf life of feed additive α-galactosidase. This document applies to the feed additive α-galactosidase prepared by fermentation and separation with or without carrier, using aspergillus niger as strains.

Products Covered: copper chloride hydroxide (HS code(s): 350790); (ICS code(s): 65.120)

Regulation Type: Regular notification

Animal feed

Law No. 306/2018 on food safety (the amendments to the Law are approved by the art. IX, point 10 of the Law No. 373/2023 on the amendment of some normative acts (regarding the facilitation of activity in the food field))

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Distribution date: 24 May 2024 | Final date for Comment: 22 April 2025

The Law aims to achieve a high level of protection of human health and consumer interests in relation to food safety, taking into account the diversity of the supply of food products, including traditional products, ensuring the efficient functioning of the national market. The amended Art. 22, paragraph 2 of the Law 306/2018 - Export of food products and feed for animals from the Republic of Moldova states the following: (2)  At the request of the food operator, the National Food Safety Agency certifies the safety of food products intended for export or re-export by issuing a HEALTH CERTIFICATE. The HEALTH CERTIFICATE is issued following the results of laboratory tests carried out by the reference laboratory or an accredited laboratory, which confirm the conformity of the food products with the food regulations of the exporting country. When performing the laboratory tests, the samples are taken by the authority issuing the certificate. The HEALTH CERTIFICATE model is presented in annex no. 2. The scope of the amended provisions is the harmonization of the national legislation with the Regulation (EC) no. 178/2002 of the European Parliament and of the Council of the European Union of 28 January 2002 establishing the principles and general requirements of food legislation, establishing the European Food Safety Authority and establishing procedures in the field of food safety, published in the Official Journal of the European Union L 31 of 1 February 2002, as last amended by Regulation (EU) 2017/745.

Products Covered: 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); Animal, vegetable or microbial fats and oils and their cleavage products; Prepared edible fats; Animal or vegetable waxes (HS code(s): 15); 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); Residues and waste from the food industries; prepared animal fodder (HS code(s): 23); Salt; Sulphur; Earths and stone; Plastering materials, lime and cement (HS code(s): 25); Essential oils and resinoids; Perfumery, cosmetic or toilet preparations (HS code(s): 33)

Regulation Type: Regular notification

Human health Food safety

Modification of Annexes 2 and 3 of the Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance; ChemO); 

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Distribution date: 27 May 2024 | Final date for Comment: 26 July 2024

Annex 2 ChemO :1. Harmonized classifications and labeling of substances (21st ATP of the EU-CLP regulation): 28 substances or groups of substances are listed in the List of harmonized classifications and labeling of dangerous substances, and 24 existing entries are modified.2. The new EU hazard classes according to delegated reulation (EU) 2023/707 for endocrine disruptors and chemicals which are difficult to degrade (persistent), which accumulate in organisms (bioaccumulation) or which, due to their mobility, can reach surface water, groundwater and ultimately drinking water, become applicable in Switzerland. They will then become mandatory in stages, first for substances, then for preparations.3. The latest developments in test methods (OECD, UN Manual of Tests and Criteria) are incorporated into Swiss legislation.Seven new entries are added to Appendix 3 ChemO (list of candidate substances). In addition, one entry is updated.

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); Environment. Health protection. Safety (ICS code(s): 13); Chemical technology (ICS code(s): 71); Rubber and plastic industries (ICS code(s): 83); Paint and colour industries (ICS code(s): 87)

Regulation Type: Regular notification

Lonza Greenwood LLC; Filing of Color Additive Petition; Notification of Petition

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Distribution date: 27 May 2024 | Final date for Comment: 22 April 2025

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Lonza Greenwood LLC, proposing that the color additive regulations be amended to provide for the safe use of sodium copper chlorophyllin in dietary supplement capsules in an amount ranging from 0.08 to 0.4 percent of the weight of the capsule, and to add fescue grass (Festuca arundinacea) as a permitted source of the color additive. The color additive petition was filed on 26 March 2024.

Products Covered: Provitamins and vitamins, natural or reproduced by synthesis, incl. natural concentrates, derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent (HS code(s): 2936); Food technology (ICS code(s): 67)

Regulation Type: Regular notification

Human health Food safety

The Egyptian Standard ES 8827 for "Fertilizers and soil conditioners- chitosan"

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Distribution date: 29 May 2024 | Final date for Comment: 22 April 2025

Products covered: Fertilizers (ICS code(s): 65.080)This addendum concerns the notification of the Ministerial Decree No.141/2024 (2 pages, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 8827 for "Fertilizers and soil conditioners- chitosan"; (14 page(s), in Arabic)It should be noted that the draft of this standard was formerly notified in G/TBT/N/EGY/403 dated 9 February 2024.Worth mentioning is that this standard has been formulated according to National Studies.Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette.Date of adoption: 22 April 2024Date of entry into force:  22 May 2024Agency or authority designated to handle comments and text available from:National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: [email protected]/[email protected]: http://www.eos.org.egTel: + (202) 22845528 Fax: + (202) 22845504

Products Covered: Fertilizers (ICS code(s): 65.080)

Regulation Type: Addendum to Regular Notification

Letter of the Federal Service for Veterinary and Phytosanitary Surveillance No. FS-ARe-7/5900-3 as of 28 May 2024

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Distribution date: 30 May 2024 | Final date for Comment: 22 April 2025

This letter introduces a temporary restriction on import of live poultry, poultry products, eggs, equipment for poultry, feed and feed additives for birds from Australia to the territory of the Russian Federation and on transit of live poultry through the Russian territory due to the outbreak of highly pathogenic avian influenza in Australia.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS code(s): 0105; 0207; 0208; 0209; 0210; 0407; 0408; 0410; 0504; 0505; 0511; 1506; 1510; 1516; 1518; 1601; 1602; 1603; 190220; 190420; 2102; 2104; 2106; 2309; 2936; 3504; 3507; 3808; 3824; 3923; 3926; 4206; 4415; 4416; 4421; 7020; 7309; 7310; 7326; 7616; 843610; 84362; 843680; 860691; 8609; 8716; 950810; 9705)

Regulation Type: Emergency notifications (SPS)

Animal health Animal diseases Zoonoses Avian Influenza

Proposed changes to the Industrial Chemicals (General) Rules and Categorisation Guidelines

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Distribution date: 31 May 2024 | Final date for Comment: 22 April 2025

An outline of the changes made to the proposed amendment following the consultation period can be found here:Response to feedback on proposed changes to AICIS categorisation, reporting & record keeping requirements | Australian Industrial Chemicals Introduction Scheme (AICIS)

Products Covered: All industrial chemicals used in Australia.

Regulation Type: Addendum to Regular Notification

Updates to medicine labelling rules: Public consultation on proposed changes to TGO 91 and TGO 92 to support medicine safety 

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Distribution date: 31 May 2024 | Final date for Comment: 30 July 2024

The Therapeutic Goods Administration (TGA) is Australia's regulatory authority for therapeutic goods. There are provisions under the Therapeutic Goods Act 1989 to establish quality standards for therapeutic goods.  These standards, known as Therapeutic Goods Orders (TGOs), can specify particular labelling, packaging or other requirements.  Once approved, TGOs are registered as legislative instruments on the Federal Register of Legislation in Australia. To support the safe use of medicines, the TGA is proposing to update labelling requirements in the following TGOs:Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO 91)Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines (TGO 92). The TGA is conducting a public consultation between 30 May and 11 July 2024 to seek feedback on proposed changes to TGO 91 and TGO 92 to address 3 medicines safety related matters.

Products Covered: Medicines

Regulation Type: Regular notification

Labelling

Establece condiciones y requisitos para autorizar el ingreso o formulación y uso de muestras de plaguicida solo para experimentación, y deroga Resolución N° 92 de 2002

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Distribution date: 31 May 2024 | Final date for Comment: 24 July 2024

La medida notificada, responde a la necesidad de realizar la actualización de los requerimientos exigibles por el SAG, para la autorización del ingreso y/o formulación de muestras experimentales.Por otro lado, se requiere:Estipular la descripción de los pasos y plazos asociados a la evaluación y resolución del trámite administrativo, para el cumplimiento de los principios celeridad, economía procedimental y de no formalización establecidos por la Ley Nº 19.880.Establecer lineamientos para la fabricación o el ingreso de muestras de plaguicidas destinadas a experimentación. Mayores detalles pueden ser revisados en el documento adjunto a esta notificación.

Products Covered: Muestras experimentales de plaguicidas para uso agrícola.

Regulation Type: Regular notification

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