Regulatory Updates

Distribution date: 25 February 2021

Kenya would like to inform WTO Members that the KS 1869: 2021 Method test for determination of solar reflectance near ambient temperature using a portable solar reflectometer, notified in G/TBT/N/KEN/160 as KS 1869: 2008 Method test for determination of solar reflectance near ambient temperature using a portable solar reflectometer was adopted on 20 January 2021 via gazette notice No. 1061 dated 20 January 2021. Document can be obtained via the following link at a basic fee. https://webstore.kebs.org/

Products Covered: Solar power systems (ICS: 27.160)

Regulation Type: Addendum to Regular Notification

Distribution date: 10 February 2021

Publication of the Decree approving the Regulations on the classification, labelling and notification of chemical substances and mixtures. __________

Products Covered: Chemical substances and mixtures

Regulation Type: Addendum to Regular Notification

Distribution date: 01 February 2021

Products covered (ICS 13.220.10) Fire Fighting This addendum concerns the notification of new Draft Egyptian Standard No. ES 734 "Portable dry chemical powder fire extinguishers" (69 pages, in Arabic). This draft specifies the principal requirements intended to ensure the safety, reliability of portable fire extinguishers, as well as determine the characteristics, minimum performance requirements, manufacturing and design, resistance to pressure and mechanical tests, test methods, maintenance and conformity assessment procedures for Portable dry chemical powder fire extinguishers  of capacities 1, 2, 3, 4, 6, 9, 12 kg, having a total mass of up to 25 kg when fully charged and packed, including vehicle fire extinguishers. Worth mentioning is that this draft standard is a local specification that fits Egyptian nature, climate and comply with the following international and European standards: ISO 7165:2017 (third edition), EN 3-7:2004+A1:2007, EN 3-8:2006, EN 3-10:2009, DIN EN 3-7:2007, DS EN 3-8:2007 COR 2008. Producers and importers are kept informed of any amendments in the Egyptian standards through the publication of administrative orders in the official gazette. Proposed date of adoption: To be determined. Proposed date of entry into force: To be determined. Agency or authority designated to handle comments and text available from: National Enquiry Point Egyptian Organization for Standardization and Quality 16 Tadreeb El-Modarrebeen St., Ameriya, Cairo – Egypt E-mail: eos@idsc.net.eg/eos.tbt@eos.org.eg Website: http://www.eos.org.eg Tel:  + (202) 22845528 Fax: + (202) 22845504

Products Covered: Chemical, textile and engineering products

Regulation Type: Addendum to Regular Notification

Distribution date: 20 January 2021

TITLE: Withdrawal of Proposed Rules; Discontinuing Three Rulemaking Efforts Listed in the Semiannual Regulatory Agenda AGENCY: Environmental Protection Agency (EPA) ACTION: Withdrawal of proposed rules SUMMARY: The Environmental Protection Agency (EPA) is withdrawing the proposed regulatory requirements described in the three proposed rules that are identified in this document. This document summarizes the proposed rules and provides a brief explanation for the Agency's decision not to finalize the proposed actions. DATES: As of 15 January 2021, the proposed rule published on 16 December 2016 (81 FR 91592; FRL-9949-86)(USA/1247); the proposed rule published on 19 January 2017 (82 FR 7432; FRL-9950-08)(USA/1270); and the portion of the proposed rule published on 19 January 2017 (82 FR 7464; FRL-9958-57)(USA/1271) that pertains to n-Methylpyrrolidone (NMP) and methylene chloride in commercial paint and coating removal, are withdrawn. This withdrawal of proposed rules and earlier actions notified under the symbol G/TBT/N/USA/1247 is identified by Docket Number EPA-HQ-OPPT-2016-0163. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2016-0163 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/1270 and subsequent addenda - Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a) G/TBT/N/USA/1271 and subsequent addenda - Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a)

Products Covered: Trichloroethylene

Regulation Type: Addendum to Regular Notification

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