Regulatory Updates

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 04 January 2024

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug /Feed additive: Ethopabate.

Products Covered: ・Meat and edible meat offal (HS codes: 02.07 and 02.09)・Animal originated products (HS code: 05.04)・Animal fats and oils (HS code: 15.01)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Veterinary drugs Food safety Human health Feed additives

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 04 January 2024

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug /Feed additive: Ethopabate.

Products Covered: ・Meat and edible meat offal (HS codes: 02.07 and 02.09)・Animal originated products (HS code: 05.04)・Animal fats and oils (HS code: 15.01)

Regulation Type: Regular notification

Maximum residue limits (MRLs) Veterinary drugs Food safety Human health Feed additives

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 04 January 2024

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Polyoxorim-zinc.

Products Covered: ・Natural honey (HS code: 04.09)・Edible vegetables and certain roots and tubers (HS codes: 07.03, 07.04, 07.05, 07.07, 07.09 and 07.10)・Edible fruit and nuts (HS codes: 08.08 and 08.11)

Regulation Type: Regular notification

Human health Food safety Pesticides Maximum residue limits (MRLs)

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 04 January 2024

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Polyoxorim-zinc.

Products Covered: ・Natural honey (HS code: 04.09)・Edible vegetables and certain roots and tubers (HS codes: 07.03, 07.04, 07.05, 07.07, 07.09 and 07.10)・Edible fruit and nuts (HS codes: 08.08 and 08.11)

Regulation Type: Regular notification

Human health Food safety Pesticides Maximum residue limits (MRLs)

Draft resolution number 1137, 27 December 2022

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Distribution date: 21 December 2023

The Draft resolution number 1137, 27 December 2022 - previously notified through  G/TBT/N/BRA/1466 - which contains provisions on rules for preparing, harmonizing, updating, publishing and making available drug inserts for patients and health professionals, was adopted as Resolution 831, 06 December 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6531822/RDC_831_2023_.pdf/8e23bf02-7bab-47b9-81e1-b445a541081c 

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Human health

Draft resolution number 1137, 27 December 2022

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Distribution date: 21 December 2023

The Draft resolution number 1137, 27 December 2022 - previously notified through  G/TBT/N/BRA/1466 - which contains provisions on rules for preparing, harmonizing, updating, publishing and making available drug inserts for patients and health professionals, was adopted as Resolution 831, 06 December 2023. The final text is available only in Portuguese and can be downloaded at:  http://antigo.anvisa.gov.br/documents/10181/6531822/RDC_831_2023_.pdf/8e23bf02-7bab-47b9-81e1-b445a541081c 

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Human health

Draft Commission Delegated Regulation amending Delegated Regulation (EU) 2022/2104 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards marketing standards for olive oil

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Distribution date: 21 December 2023 | Final date for Comment: 19 February 2024

Limit values for the characteristics of olive oil set out in Regulation (EU) 2022/2104 are set in accordance with the IOC Trade Standard applying to olive oil and olive-pomace oil (IOC Trade Standard). The IOC Trade Standard changed with regard to one chemical parameter, Δ-7-stigmastenol, and Delegated Regulation (EU) 2022/2104 should be amended accordingly.

Products Covered: 1509, Olive oil and its fractions, whether or not refined, but not chemically modified; 1510, Other oils and their fractions, obtained solely from olives, whether or not refined, but not chemically modified, including blends of these oils or fractions with oils or fractions of heading 1509;

Regulation Type: Regular notification

Food standards

Draft Commission Delegated Regulation amending Delegated Regulation (EU) 2022/2104 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards marketing standards for olive oil

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Distribution date: 21 December 2023 | Final date for Comment: 19 February 2024

Limit values for the characteristics of olive oil set out in Regulation (EU) 2022/2104 are set in accordance with the IOC Trade Standard applying to olive oil and olive-pomace oil (IOC Trade Standard). The IOC Trade Standard changed with regard to one chemical parameter, Δ-7-stigmastenol, and Delegated Regulation (EU) 2022/2104 should be amended accordingly.

Products Covered: 1509, Olive oil and its fractions, whether or not refined, but not chemically modified; 1510, Other oils and their fractions, obtained solely from olives, whether or not refined, but not chemically modified, including blends of these oils or fractions with oils or fractions of heading 1509;

Regulation Type: Regular notification

Food standards

Plant Protection Products Ordinance

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Distribution date: 20 December 2023 | Final date for Comment: 18 February 2024

The Swiss rules and conditions for the admission of Plant Protection Products continue to be harmonised with those of the European Union.

Products Covered: Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Microbiology (ICS code(s): 07.100); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Water quality (ICS code(s): 13.060); Soil quality. Pedology (ICS code(s): 13.080); Explosion protection (ICS code(s): 13.230); Farming and forestry (ICS code(s): 65.020); Pesticides and other agrochemicals (ICS code(s): 65.100)

Regulation Type: Regular notification

Plant health

Plant Protection Products Ordinance

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Distribution date: 20 December 2023 | Final date for Comment: 18 February 2024

The Swiss rules and conditions for the admission of Plant Protection Products continue to be harmonised with those of the European Union.

Products Covered: Insecticides, rodenticides, fungicides, herbicides, anti-sprouting products and plant-growth regulators, disinfectants and similar products, put up for retail sale or as preparations or articles, e.g. sulphur-treated bands, wicks and candles, and fly-papers (HS code(s): 3808); Microbiology (ICS code(s): 07.100); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Water quality (ICS code(s): 13.060); Soil quality. Pedology (ICS code(s): 13.080); Explosion protection (ICS code(s): 13.230); Farming and forestry (ICS code(s): 65.020); Pesticides and other agrochemicals (ICS code(s): 65.100)

Regulation Type: Regular notification

Plant health

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