Regulatory Updates

Draft resolution number 1014, 24 February 2021, regarding the active ingredient F47 - FLUAZINAM (fluazinam) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient F47 - FLUAZINAM (fluazinam) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the peanut, chickpea, and lentil cultures from 0.01 to 0.1 mg/kg;- changes the MRL of the pea and caupi bean cultures from 0.05 to 0.1 mg/kg;- changes the MRL of the soya culture from 0.01 to 0.02 mg/kg;- includes the phrase: "Acute Reference Dose (ARfD): 0.07 mg/kg b.w. (Source: EFSA, 2008)."

Products Covered: HS Code(s): 1201, 1202, 071320, 071340, 070810, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 1017, 24 February 2021, regarding the active ingredient T54 - TRIFLOXISTROBINA (trifloxystrobin) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient T54 - TRIFLOXISTROBINA (trifloxystrobin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the coconut culture with MRL of 0.01 mg/kg and safety security period of 1 day;- includes the pumpkin culture with MRL of 0.2 mg/kg and safety security period of 1 day;- includes the phrase: "for the purpose of residue definition for conformity to MRL, it will be considered the active ingredient trifloxystrobin, and for dietary risk assessment, it will be considered the sum of the active ingredient trifloxystrobin with its metabolite acid (E,E)-methoxyimino-{2-[1-(3- trifluorometilophenyl)-ethylideneamino-oximethyl]-phenyl}-acetic (CGA 321113), expressed as trifloxystrobin";- includes the phrase: "Acute Reference Dose (ARfD): Not applicable (source: JMPR*, 2004)";- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues".

Products Covered: HS Code(s): 08011, 07099300; ICS Code(s): 13, 65

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Draft resolution number 1015, 24 February 2021, regarding the active ingredient I05 - IPRODIONA (iprodione) of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 12 March 2021 | Final date for Comment: 01 May 2021

This Draft resolution incorporates the following changes for the active ingredient I05 - IPRODIONA (iprodione) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- includes the oats culture with MRL of 2.0 mg/kg and safety security period of 5 days;- includes the barley culture with MRL of 2.0 mg/kg and safety security period of 5 days;- includes the phrase at item "m": "Acute Reference Dose (ARfD): Not applicable (source: JMPR*, 2001)";- includes the phrase: "*The Joint FAO/WHO Meeting on Pesticide Residues";- includes the phrase at item "n": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the active ingredient iprodione".

Products Covered: HS Code(s): 1003, 1004; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Rectification of Normative Instruction number 51, 19 November 2019

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Distribution date: 09 March 2021

The annex I of the Normative Instruction number 51, 19 November 2019 - previously notified through G/SPS/N/BRA/1527/Add.2 - which establishes the MRL for veterinary drugs in food of animal origin, was rectified. The rectified text is available only in Portuguese and can be downloaded at: https://www.in.gov.br/en/web/dou/-/retificacao-305691624.

Products Covered:

Regulation Type: Addendum to Regular Notification

Veterinary drugs Food safety Maximum residue limits (MRLs) Modification of content/scope of regulation Human health

Notice of Amendment- Prescription Drug List (PDL): Vitamin D (2 pages, available in English and French)

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Distribution date: 08 March 2021

This Notice of Amendment notifies of the amendment the Prescription Drug List (PDL) qualifier for Vitamin D to allow non-prescription status to products containing up to 62.5 µg or 2,500 International Units (IU)/day for oral use. Only the Human part of the PDL has been revised.  

Products Covered: Prescription status of medicinal ingredients for human use

Regulation Type: Regular notification

DUS ARS 1482:2021, Granulated superphosphate fertilizers — Specification, First Edition

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Distribution date: 08 March 2021 | Final date for Comment: 07 May 2021

This Draft Uganda Standard specifies requirements, sampling method and test methods for granulated superphosphate fertilizers.

Products Covered: - Superphosphates : (HS code(s): 31031); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Fertilizer Management Regulation

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Distribution date: 08 March 2021 | Final date for Comment: 07 May 2021

The purpose of this Regulation is to establish a legal regime to ensure that all processes involving the activities of production, use, import, export, transit, handling and application of fertilizers are carried out without prejudice to public, animal and environmental health.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Chief Executive’s Decision No 222/2020 (1 page, in Chinese and Portuguese)

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Distribution date: 04 March 2021

Prohibition of import and transit of disposable foamed plastic tableware to the Macao Special Administrative Region.

Products Covered: Disposable Foamed Plastic Tableware, including: Disposable foamed plastic food box (ex. 3923.10.00); Disposable foamed plastic bowls and cups (ex. 3923.90.00, ex. 3924.10.00); Disposable foamed plastic plates (ex. 3924.10.00).

Regulation Type: Regular notification

Chief Executive’s Decision No. 231/2020 (1 page, in Chinese and Portuguese)

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Distribution date: 04 March 2021

Prohibition of import, export and transit of mercury and amalgam listed in The Minamata Convention on Mercury and contained in the Schedule annexed to Chief Executive’s Decision No. 231/2020 in the Macao Special Administrative Region.

Products Covered: Mercury and Amalgam 2805.40.00, 2843.90.19, 2853.90.19

Regulation Type: Regular notification

D06. Treaties

Normative Instruction number 83, 23 February 2021.

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Distribution date: 03 March 2021

This normative instruction defines the list of substances categorized as antimicrobial for use under prescription, isolated or associated.

Products Covered: Antibiotics (HS code(s): 2941); 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: Regular notification

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