Regulatory Updates

Distribution date: 25 March 2021

Protection of the Stratospheric Ozone: Motor Vehicle Air Conditioning System Servicing AGENCY: Environmental Protection Agency (EPA) ACTION: Final rule SUMMARY: The Environmental Protection Agency (EPA) is adopting three technical standards developed by SAE International (SAE) for equipment that recovers, recycles, and/or recharges the refrigerant 2,3,3,3- Tetrafluoroprop-1-ene (HFO-1234yf or R-1234yf) in motor vehicle air conditioners (MVACs). The three standards are SAE J2843, SAE J2851, and SAE J3030. This rule adopts the most current versions of these standards by incorporating them by reference into the regulations under Title VI of the Clean Air Act (CAA). This will provide additional flexibility for industry stakeholders that wish to select recovery and recycling equipment certified to these standards. DATES: This final rule is effective on 23 April 2021, 30 days after publication in the Federal Register. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of 23 April 2021. This final rule and the notice of proposed rulemaking notified as G/TBT/N/USA/1594 are identified by Docket Number EPA-HQ-OAR-2013-0597. The Docket Folder is available at https://www.regulations.gov/docket/EPA-HQ-OAR-2013-0597/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: Motor vehicle refrigerant

Regulation Type: Addendum to Regular Notification

Distribution date: 22 March 2021 | Final date for Comment: 21 May 2021

The drafts provide for expansion of the list of goods subject to veterinary control on goods from HS Code 3823 of the EAEU Commodity Nomenclature of Foreign Economic Activity, as well as specification of veterinary measures applied for goods from HS code 3823 of EAEU CN of FEA.

Products Covered: Feed additives (HS Code: from 3823)

Regulation Type: Regular notification

Distribution date: 22 March 2021 | Final date for Comment: 21 May 2021

The drafts provide for expansion of the list of goods subject to veterinary control on goods from HS Code 3823 of the EAEU Commodity Nomenclature of Foreign Economic Activity, as well as specification of veterinary measures applied for goods from HS code 3823 of EAEU CN of FEA.

Products Covered: Feed additives (HS Code: from 3823)

Regulation Type: Regular notification

Distribution date: 19 March 2021

This resolution establishes the procedure and technical requirements for the application for temporary market authorization on an emergency basis of medicines and vaccines for Covid-19 in experimental character to tackle the national public health emergency related to the outbreak of the new coronavirus (SARS-CoV-2)

Products Covered: 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

Distribution date: 19 March 2021

This resolution establishes the procedure and technical requirements for the submission of temporary and exceptional market authorization application for the import and distribution of medicines and vaccines for Covid-19 to tackle the national public health emergency related to the outbreak of the new coronavirus (SARS-CoV-2) in accordance with the Law number 14.124, 10 March 2021.

Products Covered: Antibiotics (HS code(s): 2941); Vaccines for human medicine (HS code(s): 300220); 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

Distribution date: 18 March 2021 | Final date for Comment: 17 May 2021

This regulation specifies the following: Terms and Definitions, Scope, Objectives, Supplier Obligations, Labelling, Conformity Assessment Procedures, Responsibilities of Regulatory Authorities, Responsibilities of Market Surveillance Authorities, Violations and Penalties, General Provisions, Transitional Provisions, Appendix (lists, types, safety and health requirements)

Products Covered: 3703, 3704, 4801, 4802, 4803, 4804, 4805, 4806, 4807, 4808, 4809, 4810, 4811, 4812, 4817, 4818, 4819, 4820, 4821, 4822, 4823

Regulation Type: Regular notification

Distribution date: 17 March 2021

The Draft Resolution number 927, 9 October 2020 - previously notified through G/SPS/N/BRA/1789 - was adopted as Resolution - RE number 1053, 11 March 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=15/03/2021&jornal=515&pagina=136.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 16 March 2021

The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to notify that the "Regulation for the Use Restrictions and Labeling Requirements of Astaxanthin Produced by Genetically Modified Escherichia coli Strain Ast12 as a Food Ingredient," as per G/TBT/N/TPKM/418 on 22 June 2020, was promulgated on 11 March 2021 and came into effect on the same day.

Products Covered: Food ingredient to be used in food

Regulation Type: Addendum to Regular Notification

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

This Draft resolution incorporates the following changes for the active ingredient C10 - CIPERMETRINA (cypermethrin) 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 sweet potato, yacon, beetroot, greater yam, carrot, pea, bean, ginger, chickpea, yams, lentil, arracacha, turnip, and radish cultures with safety security period of 14 days;- changes the safety security period of the peanut from 22 to 14 days;- includes the bean, chickpea, and lentil cultures with MRL of 0.05 mg/kg in the general table for cypermethrins;- changes the MRL of the yacon, greater yam, pea, turnip and radish from 0.02 to 0.05 mg/kg in the general table for cypermethrins;- includes the phrase at item "o": "Acute Reference Dose (ARfD): 0.04 mg/kg b.w. (source: JMPR*, 2006)";- includes the phrase: "*Joint FAO/WHO Meeting on Pesticides".

Products Covered: HS Code(s): 1202, 071420, 0706, 070820, 070810, 09101, 071430, 071320, 17029040000, 07143000, 0714900011; ICS Code(s): 13, 65

Regulation Type: Regular notification

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

This Draft resolution incorporates the following changes for the active ingredient C59 - BETA-CIPERMETRINA (beta-cypermethrin) 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 millet culture with MRL of 0.05 mg/kg and safety security period of 14 days;- includes the sorghum culture with MRL of 1.0 mg/kg and safety security period of 14 days.

Products Covered: HS Code(s): 1007, 10082; ICS Code(s): 13, 65

Regulation Type: Regular notification