Regulatory Updates

Distribution date: 11 January 2021 | Final date for Comment: 20 February 2021

On 5 March 2013, the Government of the Republic of Nicaragua notified, in document G/SPS/N/NIC/75, with addendum G/SPS/N/NIC/75/Add.1 of 13 May 2013, Nicaraguan Mandatory Technical Standard (NTON) No. 11 034 - 12 Import requirements for goods of animal origin. The Technical Standard has been revised and therefore, a new period for comments has been established. Text available at: https://members.wto.org/crnattachments/2021/SPS/NIC/21_0329_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 08 January 2021

Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS ACTION: Notice of availability SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Consumer Antiseptic Rub Final Rule Questions and Answers." We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the Consumer Antiseptic Rub FR, FDA established that 28 active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, which was used to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rubs are eligible for evaluation under the OTC Drug Review and granted requests to temporarily defer further rulemaking on these three eligible ingredients to allow for the development and submission of new safety and effectiveness data. The guidance is accessible from the FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consumer-antiseptic-rub-final-rule-questions-and-answers-guidance-industry, and is intended to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR) (84 FR 14847, 12 April 2019), which applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products that are sometimes referred to as rubs, leave-on products, or hand sanitizers. The Consumer Antiseptic Rub FR also applies to active ingredients used in OTC consumer antiseptic wipes. This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page: Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research. DATES: The announcement of the guidance is published in the Federal Register on 31 December 2020. This notice of availability and previous actions notified under the symbol G/TBT/N/USA/1167 are identified by Docket Number FDA-2016-N-0124 (Formerly Docket No. FDA-1975-N-0012). The Docket Folders are available on Regulations.gov at https://www.regulations.gov/docket?D=FDA-2016-N-0124 and https://www.regulations.gov/docket?D=FDA-1975-N-0012 and provide access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Numbers. G/TBT/N/USA/875 and subsequent addenda - Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use.

Products Covered: Topical antimicrobial drug products

Regulation Type: Addendum to Regular Notification

Distribution date: 08 January 2021

Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS ACTION: Notice of availability SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Consumer Antiseptic Rub Final Rule Questions and Answers." We are issuing this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the Consumer Antiseptic Rub FR, FDA established that 28 active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, which was used to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rubs are eligible for evaluation under the OTC Drug Review and granted requests to temporarily defer further rulemaking on these three eligible ingredients to allow for the development and submission of new safety and effectiveness data. The guidance is accessible from the FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/consumer-antiseptic-rub-final-rule-questions-and-answers-guidance-industry, and is intended to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR) (84 FR 14847, 12 April 2019), which applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products that are sometimes referred to as rubs, leave-on products, or hand sanitizers. The Consumer Antiseptic Rub FR also applies to active ingredients used in OTC consumer antiseptic wipes. This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page: Office of Communications, Division of Drug Information, Center for Drug Evaluation and Research. DATES: The announcement of the guidance is published in the Federal Register on 31 December 2020. This notice of availability, the proposed rule notified as G/TBT/N/USA/875 and the final rule notified as G/TBT/N/USA/875/Add.2 are identified by Docket Number FDA-2016-N-0124 (Formerly Docket No. FDA-1975-N-0012). The Docket Folders are available on Regulations.gov at https://www.regulations.gov/docket?D=FDA-2016-N-0124 and https://www.regulations.gov/docket?D=FDA-1975-N-0012 and provide access to primary and supporting documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Numbers. Related actions notified as G/TBT/N/USA/875/Add.1 and G/TBT/N/USA/875/Add.3 are identified by Docket Number FDA-2015-N-0101. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=FDA-2015-N-0101 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. G/TBT/N/USA/1167 and subsequent addenda - Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record.

Products Covered: Consumer antiseptics

Regulation Type: Addendum to Regular Notification

Distribution date: 07 January 2021

Regulation of the Chairperson of Indonesia FDA Number 13 of 2020 is the revised version of Regulation of the Chairperson of Indonesian FDA Number 22 of 2016 on Requirements the Use of Flavouring. This regulations covers about classification of flavouring, maximum level of flavouring, list of flavouring adjunct, list of flavoring substances, list of the Sources of Natural Aromatic Raw Materials and/or Sources of Flavoring Preparations, The name of flavouring substances allowed to be used as flavouring, List of flavouring which allowed to be used in follow up formula, List of flavouring which allowed to be used in Complementary foods for infants and young children, Maximum residue of Extraction solvent in food product which used for process flavouring, the labelling and also the requirements for submission of the use of flavoring which is not covered in this regulation. The new provisions of this regulation include: list of solvent as flavouring adjunct, and list of the Sources of Natural Aromatic Raw Materials and/or Sources of Flavoring Preparations. The Flavouring and Processed Food contain flavouring which has a marketing approval must adjust with this regulation no later than 24 months from the date of enactment.

Products Covered: Food Additives, Flavoring

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 1662:2017, Hair spray — Specification; notified in G/TBT/N/UGA/691, G/TBT/N/UGA/691/Add.1, G/TBT/N/UGA/691/Corr.1 and G/TBT/N/UGA/691/Add.1/Corr.1 was withdrawn on 15 December 2020.

Products Covered: Hair spray

Regulation Type: Addendum to Regular Notification

Distribution date: 06 January 2021

The aim of this addendum is to inform WTO Members that the Uganda Standard; US 47:2011, Carbonated and non–carbonated soft drinks – Specification; notified in G/TBT/N/UGA/182 was withdrawn on 15 December 2020.

Products Covered: Beverages – Non-alcoholic, 67.160.20

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2021

Regulation amending and supplementing the national technical regulation on Wood adhesives promulgated by Circular No. 40/2018/TT-BNNPTNT, dated 27 December 2018, of the Ministry of Agriculture and Rural Development. AGENCY: Ministry of Agriculture and Rural Development No. 2 Ngoc Ha street, Ba Dinh District, Hanoi, Vietnam Tel: (+84-24) 37349845Fax: (+84-24) 38438793Website: http://tongcuclamnghiep.gov.vn/Email: congttdt@gmail.com. SUMMARY1. Amend regulations on  the scope of regulation in Section 1.1, National technical regulation on Wood adhesives as follows:- This regulation prescribes the limit of free formaldehyde content in wood adhesives containing formaldehyde components domestically produced, imported and circulated in the Vietnamese market.- This Regulation does not apply to wood adhesives products and goods imported in the form of test samples; sample; exhibition goods; goods temporarily imported for re-export, goods in transit2. Amend regulations on regulation conformity announcement methods in Section 3.1.1 The Regulation as follows:Wood adhesives products and goods containing formaldehyde components must be declared compliant with the free formaldehyde content limit specified in Table 2.1, Part 2 of this draft technical regulation, basing on results of certification of a certification body registered or recognized in accordance with the law.  The testing for regulation conformity announcement shall be carried out at testing bodies that have been granted the certificate of registration of testing activities according to the provisions of Decree No. 107/2016/ND-CP dated July 1, 2016 regulating on business conditions of conformity assessment services3. Supplement a provision on responsibility of the state management agency in management of the quality and conformity declaration of wood adhesives products in Section 4.1 of the technical regulation as follows:- Vietnam Administration of Forestry is responsible for inspection and consideration of exemption from inspection of quality of products and goods that contain formaldehyde-containing wood adhesives.- Department of Agriculture and Rural Development of the provinces and cities under the central government receive the dossier of regulation conformity announcement and post it on its portal. PROPOSED DATE OF ADOPTION: April 2021PROPOSED DATE OF ENTRY INTO FORCE: October 2021FINAL DATE FOR COMMENTS: 60 days from the date of notification

Products Covered: Wood adhesives

Regulation Type: Addendum to Regular Notification

Distribution date: 05 January 2021

The aim of this addendum is to inform WTO Members that the Draft Uganda Standard; DUS 47:2010, Carbonated and non–carbonated soft drinks – Specification; notified in G/TBT/N/UGA/182 was adopted on 15 December 2020. The adopted Uganda Standard, US 47:2020, Carbonated and non–carbonated soft drinks – Specification, can be purchased online through the link: https://webstore.unbs.go.ug/

Products Covered: Beverages – Non-alcoholic, 67.160.20

Regulation Type: Addendum to Regular Notification

Distribution date: 17 December 2020

Draft Compliance Guide for Imported Articles Containing Surface Coatings Subject to the Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances Significant New Use Rule; Notice of Availability and Request for Comment AGENCY: Environmental Protection Agency (EPA) ACTION: Notice SUMMARY: The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on the draft compliance guide for the significant new uses EPA identified under the Toxic Substances Control Act (TSCA) for the import of articles with certain long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals as part of the surface coating, as established by EPA's final rule "Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule." Specifically, the guide provides additional clarity on what is meant by a "surface coating," identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final significant new use rule (SNUR). Comments must be received on or before 15 January 2021. This notice announcing the availability of and soliciting public comment on the draft compliance guide is identified by Docket Number EPA-HQ-OPPT-2020-0621. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2020-0621 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. WTO Members and their stakeholders are asked to submit comments to the USA TBT Enquiry Point. Comments received by the USA TBT Enquiry Point from WTO Members and their stakeholders will be shared with the regulator and will also be submitted to the Docket on Regulations.gov if received within the comment period. Previous actions notified under the symbol G/TBT/N/USA/956 are identified by Docket Number EPA-HQ-OPPT-2013-0225. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2013-0225 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: Long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances

Regulation Type: Addendum to Regular Notification

Distribution date: 14 December 2020

AGENCY: Environmental Protection Agency (EPA) ACTION: Determination of acceptability SUMMARY: This determination of acceptability expands the list of acceptable substitutes pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy (SNAP) program. This action lists as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, and fire suppression sectors. This determination is applicable on 11 December 2020. This determination of acceptability and previous actions notified under the symbol G/TBT/N/USA/1013 are identified by Docket Number EPA-HQ-OAR-2003-0118. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OAR-2003-0118 and provides access to primary 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