Regulatory Updates

Distribution date: 17 May 2021

ANVISA Resolution number 483, 19 March 2021- previously notified through  G/TBT/N/BRA/1154 - which establishes exceptional and temporary technical requirements for the import of new medical devices and medicines identified as indispensable for the use in healthcare services due to the international public health emergency related to the SARS-CoV-2. , was changed by Resolution – RDC  number 496, 11 May 2021.   The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6245812/RDC_496_2021_.pdf/70d5b5d6-5381-4ddf-9c2d-1828dc094d6e

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); Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof "incl. chain modified polypeptides", used primarily as hormones (HS code(s): 2937); Antibiotics (HS code(s): 2941); PHARMACEUTICAL PRODUCTS (HS code(s): 30); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification

Distribution date: 17 May 2021

This addendum aims to inform that the National Institute of Metrology, Quality and Technology – INMETRO, issued a rectification Inmetro Ordinance N° 206, 4 May 2021, published in the Brazilian Official Gazette on 5 May 2021, section 1, page 72 – previously notified through G/TBT/N/BRA/1174 – where it reads: "Metrological Technical Regulation - RTM established by Ordinance 205, 04 May 2021.", should read: "Metrological Technical Regulation - RTM established by Ordinance 206, 04 May 2021."

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 12 May 2021

This Ordinance approves the Metrological Technical Regulation that establishes the criteria for verifying the liquid content of the insecticide or liquid repellent product commercialize in a container to be coupled to an electrical device – Consolidated.

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); Insecticides (ICS code(s): 65.100.10)

Regulation Type: Regular notification

Distribution date: 11 May 2021

The Normative Instruction number 51, 19 December 2019 - previously notified through G/SPS/N/BRA/1527/Add.2 - which establishes Maximum Residue Limit (MRL), Acceptable Daily Intake (ADI), and Acute Reference Dose (ARfD) of Active Pharmaceutical Ingredient (API) for veterinary drugs in food of animal origin, was changed by the Normative Instruction number 89, 8 April 2021. The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/documents/10181/6257261/IN_89_2021_.pdf/8c7c3a2a-133c-45bf-b246-3b60f4c15d2f.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021

The Draft Resolution number 1005, 27 January 2021 - previously notified through G/SPS/N/BRA/1894 - was adopted as Resolution - RE number 1422, 8 April 2021.The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=12/04/2021&jornal=515&pagina=130.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021

The Draft Resolution number 1006, 27 January 2021 - previously notified through G/SPS/N/BRA/1895 - was adopted as Resolution - RE number 1423, 8 April 2021.The full text is available only in Portuguese and can be downloaded at:https://pesquisa.in.gov.br/imprensa/jsp/visualiza/index.jsp?data=12/04/2021&jornal=515&pagina=130.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021 | Final date for Comment: 20 June 2021

This Draft resolution incorporates the following changes for the active ingredient Q05.1 - QUIZALOFOPE-P-ETÍLICO (quizalofop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the phrase at item "h": Acceptable Daily Intake (ADI): 0,009 mg/kg b.w. (source: EFSA*, 2009);- includes the phrase at item "i": Acute Reference Dose (ARfD): Not applicable (source: EFSA*, 2009);- includes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the active ingredient quizalofop, its salts, esters (including propaquizafop), and conjugateds, expressed as quizalofop";- includes the phrase: "*European Food Safety Authority".This Draft resolution incorporates the following changes for the active ingredient Q05.2 - QUIZALOFOPE-P-TEFURÍLICO (quizalofop-P) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:- includes the phrase at item "h": Acceptable Daily Intake (ADI): 0,013 mg/kg b.w. (source: EFSA*, 2008);- includes the phrase at item "i": Acute Reference Dose (ARfD): 0,1 mg/kg b.w. (source: EFSA*, 2008);- includes the phrase at item "j": "for the purpose of residue definition for conformity to MRL and dietary risk assessment, it will be considered the sum of the active ingredient quizalofop, its salts, esters (including propaquizafop), and conjugateds, expressed as quizalofop";- includes the phrase: "*European Food Safety Authority".

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

Regulation Type: Regular notification

Distribution date: 11 May 2021 | Final date for Comment: 20 June 2021

This Draft Resolution includes the active ingredient P62 - PEPTÍDEOS DERIVADOS DA PROTEÍNA HARPIN in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

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

Regulation Type: Regular notification

Distribution date: 11 May 2021

TITLE: Protection of Stratospheric Ozone: Listing of Substitutes Under the Significant New Alternatives Policy Program AGENCY: Environmental Protection Agency (EPA) ACTION: Final rule SUMMARY: Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action lists certain substances in the refrigeration and air conditioning sector. For the retail food refrigeration--medium-temperature stand-alone units (new) end-use, EPA is listing three substitutes as acceptable subject to narrowed use limits. For the residential and light commercial air conditioning and heat pumps (new) end-use, EPA is listing six substitutes as acceptable subject to use conditions. Through this action, EPA is incorporating by reference the 2019 Underwriters Laboratories (UL) Standard 60335-2-40, 3rd Edition, which establishes requirements for the evaluation of electrical air conditioners, heat pumps, and dehumidifiers, and safe use of flammable refrigerants. This action also removes an acceptable subject to use conditions listing for the fire suppression sector because EPA more recently listed the substitute as acceptable with no use restrictions. DATES: This rule is effective 7 June 2021. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of 7 June 2021. This final rule and the proposed rule notified as G/TBT/N/USA/1626 are identified by Docket Number EPA-HQ-OAR-2019-0698. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/EPA-HQ-OAR-2019-0698/document and provides access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number.

Products Covered: Chemical substances

Regulation Type: Addendum to Regular Notification

Distribution date: 11 May 2021 | Final date for Comment: 10 July 2021

Labelling language: Currently, certain chemical products must bear labels in two official languages. However, certain products are legally placed on the market in the Italian-speaking regions of the country despite not bearing labels in Italian. In the future, the language selected for the labelling of all chemical products (e.g. phytosanitary, biocidal and household products, and fertilizers) will be the official language of the place of issue of the products. Procedure for the notification of new substances: The revision also aims to modernize the procedure for the notification of new substances. Currently, only substances that are not on a list of existing substances (EINECS) must be notified with a defined set of data before being placed on the market. In the future, all substances that are not registered in the European Union must be notified. Lastly, the following two changes have been made to the rules on the communication of preparations: - The possibility for the declaration of certain perfumes and colourings using only a generic name is envisaged. - Custom-made paints prepared in limited quantities for a specific consumer or professional user, made up at the point of sale, may be exempt from mandatory communication.

Products Covered: Chemical products, biocidal products, phytosanitary products and fertilizers; Inorganic chemicals; Organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes (HS 28); Organic chemicals (HS 29); Fertilizers (HS 31); Soap, organic surface-active agents, washing preparations, lubricating preparations, artificial waxes, prepared waxes, polishing or scouring preparations, candles and similar articles, modelling pastes, "dental waxes" and dental preparations with a basis of plaster (HS 34); Miscellaneous chemical products (HS 38); Environment. Health protection. Safety (ICS 13); Chemical technology (ICS 71)

Regulation Type: Regular notification