Regulatory Updates
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations AGENCY: Food and Drug Administration, HHS ACTION: Notice SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by 19 June 2020. The docket folder on Regulations.gov provides access to primary documents for this Notice as well as comments received: https://www.regulations.gov/docket?D=FDA-2013-N-1155. WTO members who wish to comment are requested to submit their comments by e-mail to usatbtep@nist.gov.
Distribution date: 25 May 2020
Products Covered: Food products, labeling
Regulation Type: Addendum to Regular Notification
KS 1941-2:2018 Kenya Standard — Scouring compounds — Specification Part 2: Antibacterial dishwashing paste Kenya would like to inform WTO Members that the Kenya Standard KS 1941-2: 2019 Kenya Standard — Scouring compounds — Specification Part 2: Antibacterial dishwashing paste; notified in G/TBT/N/KEN/591 as KS 1941-2 was adopted on 7 August 2018 via gazette notice No. 8456 dated 7 August 2018. A copy of the document can be obtained via the following link at a basic fee. https://webstore.kebs.org/
Distribution date: 20 May 2020
Products Covered:
Regulation Type: Addendum to Regular Notification
KS 1941-1:2018 Kenya Standard — Scouring compounds — Specification Part 1: Dishwashing paste Kenya would like to inform WTO Members that the Kenya Standard KS 1941-1: 2019 Kenya Standard — Scouring compounds — Specification Part 1: Dishwashing paste; notified in G/TBT/N/KEN/590 as KS 1941-1 was adopted on 7 August 2018 via gazette notice No. 8456 dated 7 August 2018. A copy of the document can be obtained via the following link at a basic fee. https://webstore.kebs.org/
Distribution date: 20 May 2020
Products Covered:
Regulation Type: Addendum to Regular Notification
KS 1941-3:2018 Kenya Standard — Scouring compounds — Specification Part 3: Dishwashing bar Kenya would like to inform WTO Members that the Kenya Standard KS 1941-3: 2019 Kenya Standard — Scouring compounds — Specification Part 3: Dishwashing bar; notified in G/TBT/N/KEN/589 as KS 1941-3 was adopted on 23 February 2018 via gazette notice No. 1721 dated 23 February 2018. A copy of the document can be obtained via the following link at a basic fee. https://webstore.kebs.org/
Distribution date: 20 May 2020
Products Covered:
Regulation Type: Addendum to Regular Notification
KS 2720:2016 Amd 1:2018 Kenya Standard — Nonwoven disposable wet wipes Kenya would like to inform WTO Members that the Kenya Standard KS 2720:2016 Amd 1:2018 Kenya Standard — Nonwoven disposable wet wipes; notified in G/TBT/N/KEN/568 as KS 2720 was adopted on 7 August 2018 via gazette notice No. 8456 dated 7 August 2018. A copy of the document can be obtained via the following link at a basic fee. https://webstore.kebs.org/
Distribution date: 20 May 2020
Products Covered:
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 11.03.64:11: "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements" On 30 January 2020, the Government of the Republic of Honduras notified, in document G/TBT/N/HND/73/Add.1, Central American Technical Regulation (RTCA) No. 11.03.64:11: "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements". The purpose of this Technical Regulation is to establish conditions and requirements for the sanitary registration of natural medicines for human use intended for marketing. It applies to natural medicines for human use that are manufactured or imported by natural or legal persons for marketing in the Central American region. This Technical Regulation does not apply to products containing, as the constituent responsible for pharmacological activity, active substances that are chemically synthesized or isolated from natural material, or to ophthalmic or parenteral pharmaceutical products. Furthermore, WTO Members are advised that the deadline for submitting comments or observations has been extended until 28 April 2020. The relevant text is available from: Secretaría de Desarrollo Económico Dirección General de Integración Económica y Política Comercial Boulevard José Cecilio del Valle Edificio San José, 3er piso Fax: (+504) 2235-8383 / 2235-5047 Email: gsalinas_sic@yahoo.com Website: https://sde.gob.hn/wp-content/uploads/2020/01/RTCA-Registro-Naturales-Medicinales-versi%C3%B3n-CPI.pdf Agencia de Regulación Sanitaria (ARSA) Dirección de Productos Farmacéuticos y otros Productos de Interés Sanitario Calle Los Alcaldes, Frente al City Mall Email: consultapublica@arsa.gob.hn Website: http://www.arsa.gob.hn
Distribution date: 23 April 2020
Products Covered: ICS 11.120.10
Regulation Type: Addendum to Regular Notification
The European Union would like to inform the WTO Members of the adoption of COMMISSION IMPLEMENTING REGULATION (EU) 2020/479 of 1 April 2020 amending Regulation (EC) No 1235/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries. Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 was published on 20 July 2007 (OJ L 189, 20.7.2007, p. 1–23) and notified to the WTO under reference G/TBT/N/EEC/101/Add.1; it is available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:189:0001:0023:EN:PDF Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries was published on 12 December 2008 (OJ L 334, 12.12.2008, p. 25–52) and notified to the WTO under G/TBT/N/EEC/101/Add 2; it is available at: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:334:0025:0052:EN:PDF Commission Implementing Regulation (EU) 2020/25 amending Regulation 1235/2008 clarified that the Certificate of inspection had to be issued before the consignment leaves the third country of export or origin. It was notified to the WTO under reference G/TBT/N/EEC/101/Add.3 and is available at https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1581329223025&uri=CELEX:32020R0025 It appears that, in some cases, complete transport documents are not available to the control body in due time to allow that all the transport information is included in the certificate of inspection before the consignment of organic products leaves the third country. For that reason, Regulation (EU) 2020/479 specifies that the information contained in the transport documents has to be included in the certificate of inspection by the relevant control authority or control body within maximum 10 days from the issuance of the certificate, and, in any case, before the endorsement of the certificate by Member State’s authorities. The text of the Implementing Regulation is available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.102.01.0004.01.ENG&toc=OJ:L:2020:102:TOC
Distribution date: 22 April 2020
Products Covered: Agricultural and aquaculture products intended to be marketed as organic in the EU
Regulation Type: Addendum to Regular Notification
TITLE: Food Standards; General Principles and Food Standards Modernization; Extension of Comment Period AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; extension of comment period SUMMARY: The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule that appeared in the Federal Register of 20 May 2005. The proposed rule, entitled "Food Standards; General Principles and Food Standards Modernization," would establish a set of general principles for food standards for FDA to use when considering whether to establish, revise, or eliminate a food standard. The proposed rule was issued jointly with the U.S. Department of Agriculture (USDA) and, while FDA will continue to engage with USDA regarding the proposed rule, we are extending the comment period to allow interested persons additional time to submit comments. DATES: We are extending the comment period on the proposed rule that published in the Federal Register of 20 May 2005 (70 FR 29214). Submit either electronic or written comments by 20 July 2020. Primary and Supporting Documents, as well as Comments, are accessible from Regulations.gov at: https://www.regulations.gov/docket?D=FDA-1995-N-0062.
Distribution date: 21 April 2020
Products Covered: Foods for human consumption in the United States, except for meat, poultry and egg products (ICS: 67.040)
Regulation Type: Addendum to Regular Notification
The Ministry of Agriculture, Livestock and Food Supply – MAPA, Brazil, has issued the Technical Regulation No. 16, 19 March 2020, published in the Official Gazette No. 056 on 23 March 2020, amending the Technical Regulation No. 06, 03 April 2012, notified under reference G/TBT/N/BRA/357/Add.1, concerning the requirements of identity and quality standards of fermented acetic products. The regulation came into force on the day of its publication. The full text in Portuguese is available for consultation at:
Distribution date: 30 March 2020
Products Covered: Fermented acetic products.
Regulation Type: Addendum to Regular Notification
Turkish Food Codex Regulation on Food Additives
Distribution date: 09 March 2020 | Final date for Comment: 16 March 2020
The proposal notified in G/SPS/N/TUR/31 (26/08/2013) has been amended in the scope of the consumption patterns of paste. The other products based on tomato and red pepper which have been used for the purpose of cooking, will be added into the content/scope of the exist Communiqué on tomatoes and red pepper paste and puree. The preservatives (sorbates-benzoates) should not be used in tomato/red pepper pastes and purees. In addition of the other cooking/edible products based on tomato and red pepper into the related Communique, the Turkish Food Codex Regulation on Food Additives has been modified according to this modification.
Products Covered: Food additives
Regulation Type: Addendum to Regular Notification
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