Regulatory Updates

Normative Instruction number 119, 23 February 2022

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Distribution date: 15 March 2022

This resolution contains provisions on technical attributes of medical devices selected for economic monitoring by Anvisa.

Products Covered: Medical Devices (HS 3006)

Regulation Type: Regular notification

The Resolution number 600, 09 February 2022 - previously notified through G/TBT/N/BRA/1307- which stablishes the list of allowed ultraviolet filters for personal hygiene products, cosmetics and perfumes and internalizes GMC MERCOSUR Resolution No. 44/2015, amended by GMC MERCOSUR Resolution No. 14/2021, was rectified.  

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Distribution date: 15 March 2022

Products Covered: HS – 3304, 3303, 3306, 3307 (toiletries, cosmetics and perfumes)

Regulation Type: Corrigendum to Regular Notification

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: 14 March 2022

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

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Animal originated products (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.05, 12.07 and 12.12) - Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cocoa (HS Code: 18.01)

Regulation Type: Regular notification

Human health Pesticides Food safety 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: 14 March 2022 | Final date for Comment: 13 May 2022

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

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01,07.02, 07.03 07.04, 07.05, 07.06, 07.07, 07.08, 07.09 , 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10,02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07, 12.10 and 12.12)

Regulation Type: Regular notification

Human health Pesticides Food safety 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: 14 March 2022 | Final date for Comment: 13 May 2022

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

Products Covered: - Edible vegetables and certain roots and tubers (HS Codes: 07.01,07.02, 07.03 07.04, 07.05, 07.06, 07.07, 07.08, 07.09 , 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10,02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07, 12.10 and 12.12)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Motif FoodWorks, Inc.; Filing of Color Additive Petition

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Distribution date: 16 February 2022

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Motif FoodWorks, Inc., proposing that the color additive regulations be amended to provide for the safe use of myoglobin as a color additive in meat and poultry analogue products. The color additive petition was filed on 13 December 2021.

Products Covered: HS Code(s): 20, 3203; ICS Code(s): 67

Regulation Type: Regular notification

Food additives Human health Food safety

Draft Decision of the Council of the Eurasian Economic Commission on Amendment to the Annex to the Decision of the Commission of the Customs Union dated 23 September 2011, No. 810

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Distribution date: 16 February 2022 | Final date for Comment: 11 April 2022

The draft provides for the specification of veterinary measures for particular goods classified under Group 29 of the Common Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union.

Products Covered: Goods (products) subject to veterinary control (HS Code: 2922410000)

Regulation Type: Regular notification

Animal health Animal diseases

Establishment of a new labelling rule for Normal Fertilizers

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Distribution date: 15 February 2022 | Final date for Comment: 16 April 2022

MAFF, the government of Japan will amend the administerial rule to newly establish a labelling standard for the use of coating materials, such as sulfur and plastics in Normal Fertilizers.

Products Covered: Fertilizer (HS: 3101,3102, 3103, 3104, 3105)

Regulation Type: Regular notification

Labelling

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: 14 March 2022 | Final date for Comment: 13 May 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide/Veterinary drug: Spinosad.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07, 04.08 and 04.09) - Animal originated products (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.02, 12.07 and 12.12)- Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)       

Regulation Type: Regular notification

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

Draft Decision of the Council of the Eurasian Economic Commission on Amendments to the Annex to the Decision of the Commission of the Customs Union as of 23 September 2011, No. 810

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Distribution date: 14 February 2022 | Final date for Comment: 11 April 2022

The draft provides for the specification of veterinary measures for particular goods classified under the Group 29 of the Common Commodity Nomenclature of Foreign Economic Activity of the Eurasian Economic Union.

Products Covered: Lysine and its esters; salts thereof (HS Code: 2922 41)

Regulation Type: Regular notification

Animal health Animal diseases

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