Draft Resolution number 804, 27 March 2020

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Distribution date: 07 April 2020 | Final date for Comment: 30 May 2020

This draft resolution establishes the exclusion of the active ingredients A48 – Aviglicina (aviglycine); B25 – Butralina (butralin); D23 – Dissulfotom (disulfoton); D42 – Dinocape (dinocap); F57 – Fenotiol (fenotiol); F60 - Flufenpir (flufenpir); O17 – Octanoato de ioxinila (Ioxynil octanate) e T10 – Tetradifona (tetradifon) from Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE no. 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003 due to no formulated products with those active ingredients having marketing authorization. 

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides

Draft Resolution number 805, 27 March 2020

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Distribution date: 07 April 2020 | Final date for Comment: 05 August 2020

This resolution establishes administrative procedure for the concession of Good Manufacturing Practices Certification for medicines, medical devices, personal hygiene products, cosmetics, perfumes, sanitizers, active pharmaceutical ingredients, and food; and Good Practices of Storage and Distribution Certification for medicines, medical devices, and active pharmaceutical ingredients.

Products Covered: HS Code(s): 2106, 29, 2936, 2937, 2941, 3303, 3304, 3305, 3306, 3307, 340111, 340130, 3402, 340119, 340120, 330290, 9616, 9619; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up

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Distribution date: 07 April 2020 | Final date for Comment: 06 June 2020

This draft Regulation relates to a new entry of Annex XVII to Regulation (EC) No 1907/2006. It would restrict the placing on the market and the use of substances in mixtures for use for tattooing purposes. These substances are: (i) substances with harmonised classification under Regulation (EC) No 1272/2008 (CLP) as carcinogenicity, mutagenicity or toxicity to reproduction, skin sensitisation, skin corrosion or irritation and serious eye damage or irritation; (ii) substances prohibited by the Cosmetic Products Regulation, Regulation (EC) No 1223/2009  Annex II and Annex IV under specific conditions as listed in its columns g, h and i and (iii) impurities exceeding the concentration limits as listed in the Appendix to the draft Commission Regulation. Application of the restriction is deferred for 1 year to allow sufficient time to adapt and achieve compliance with the Regulation.

Products Covered: Tattoo inks or permanent make-up

Regulation Type: Regular notification

Revision of the fertilizer legislation: Amendment of the notification form required to submit prior to production of composite fertilizers

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Distribution date: 06 April 2020 | Final date for Comment: 05 June 2020

The MAFF will amend the Ordinance for the Enforcement of the Fertilizer Regulation Act to revise the notification form which fertilizer producers must submit to the local government before beginning production of particular composite fertilizers in order that the MAFF properly take into account the production situation to the distribution policy. The amendment will add a new item “kind of fertilizer” to the form.  Currently fertilizer producers are required to notify name of composite fertilizer, name and address of producer, plant and storage place at least two weeks before beginning production of composite fertilizers.

Products Covered: Fertilizer (HS: 3101)

Regulation Type: Regular notification

Resolution – RDC number 356, 23 March 2020 – previously notified through G/TBT/N/BRA/993 – which establishes exceptional criteria and procedure for the manufacturing, import, and acquisition of medical devices identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2, was republished. The final text is available only in Portuguese and can be downloaded at:

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Distribution date: 03 April 2020

Products Covered: HS Code(s): 2936, 2937, 3001, 3002, 3003, 3004, 3006 (medical devices)

Regulation Type: Addendum to Regular Notification

E09. COVID-19 TBT

Resolution – RDC number 347, 19 March 2020

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Distribution date: 03 April 2020

This resolution establishes temporary and exceptional criteria and procedure for the sale of antiseptic preparations and sanitizers due to the international public health emergency related to the SARS-CoV-2.

Products Covered: HS Code(s): 33079090, 38089990, 3402 (antiseptic preparations, sanitizer)

Regulation Type: Regular notification

E09. COVID-19 TBT

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/7061 as of 06 March 2020.

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Distribution date: 03 April 2020

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from the South Africa due to the registration ASF outbreaks.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen (HS Code(s): 0103; 0203; of 0511; 020630000; 020910; 4103300000; of 0210; of 5002; of 0511, 0f 9601; of 9705 00 000 0; 3101; 2309* of 160100*; 1602*) *with exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the production of feeds for non-productive and fur-producing animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Animal diseases African swine fever (ASF) Animal health Zoonoses

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/7068 as of 06 March 2020

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Distribution date: 03 April 2020

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from Kenya due to the registration of ASF outbreaks.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen (HS Code(s): 0103; 0203; of 0511; 020630000; 020910; 4103300000; of 0210; of 5002; of 0511, 0f 9601; of 9705 00 000 0; 3101; 2309* of 160100*; 1602*) *with exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the production of feeds for non-productive and fur-producing animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Animal diseases African swine fever (ASF) Animal health Zoonoses

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/6356 as of 02 March 2020

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Distribution date: 03 April 2020

This letter introduces a temporary restriction on import of life poultry and poultry products from Dominican Republic mentioned in point 3 due to the outbreak of Newcastle disease virus.

Products Covered: Life poultry and hatching egg, poultry meat and poultry processed products not heat-treated (at least 70 °C), feeds and feed additives for poultry (with the exception of feed additives of vegetable origin, chemical and microbiological synthesis), used equipment and supplies for transportation, breeding, stockkeeping, slaughtering and cutting of poultry from Dominican Republic (HS Code(s): of 0105, of 0106, of 0207, of 0208, of 0209, of 0210, of 0407, of 0408, 0410000000, of 0510000000, of 0504000000, of 0505, of 0507, of 1501, of 0511, of 150300, of 1506000000, of 151610, of 151800, of 160100, of 1602, of 160300, of 190220, of 190420, of 2104, of 2106, of 2309, of 2301, of 2309, of 3101000000, of 3502, of 350400, of 3507, of 4206000000, of 9508100000, of 9705000000)

Regulation Type: Emergency notifications (SPS)

Animal diseases Animal health Newcastle Disease Zoonoses

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

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Distribution date: 03 April 2020

The proposed maximum residue limits (MRLs) for Dithianon notified in G/SPS/N/JPN/664 (dated 31 July 2019) were adopted and published on 31 October 2019. The specified MRLs are available as below.

Products Covered:

Regulation Type: Addendum to Regular Notification

Food safety Maximum residue limits (MRLs) Human health Pesticides

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