Regulatory Updates
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
TITLE: Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule; Supplemental Proposal AGENCY: Environmental Protection Agency (EPA) ACTION: Supplemental notice of proposed rulemaking SUMMARY: EPA is supplementing a proposed significant new use rule (SNUR) issued under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. This subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. This supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in this document. The required significant new use notification would initiate EPA's evaluation of the conditions of use associated with the intended significant new use. Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. Comments must be received on or before 17 April 2020. The docket folder on Regulations.gov provides access to primary and supporting documents for this rulemaking as well as the comments received: https://www.regulations.gov/docket?D=EPA-HQ-OPPT-2013-0225. WTO members and their interests are encouraged to send comments to usatbtep@nist.gov.
Distribution date: 06 March 2020
Products Covered: Long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances
Regulation Type: Addendum to Regular Notification
Products covered: ICS 81.040.20 (Glass in building) This addendum concerns the notification of the Draft Egyptian standard ES 353-4 "Glass in building - Basic soda lime silicate glass products – Part 4: patterned glass" (15 pages, in Arabic). It should be noted that the Ministerial Decree No. 423/2005 (25 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/3 dated 14 December 2005 mandated among others the earlier version of this Egyptian Standard. Worth mentioning is that this standard is technically identical with EN 572-5/2012 Producers and importers are kept informed of any amendments in the Egyptian standard through the publication of administrative orders in the official gazette. Date of adoption: To be determined. Date of entry into force: To be determined. Agency or authority designated to handle comments and text available from:National Enquiry PointEgyptian Organization for Standardization and Quality16 Tadreeb El-Modarrebeen St., Ameriya, Cairo - EgyptE-mail: eos@idsc.net.eg/eos.tbt@eos.org.egWebsite: http://www.eos.org.egTel: + (202) 22845528Fax: + (202) 22845504
Distribution date: 05 March 2020
Products Covered: Chemical, textile and engineering products
Regulation Type: Addendum to Regular Notification
TITLE: Food Standards; General Principles and Food Standards Modernization; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; reopening of the comment period SUMMARY: The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule, published in the Federal Register of 20 May 2005, entitled "Food Standards; General Principles and Food Standards Modernization," to 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 United States Department of Agriculture (USDA) and, while FDA will continue to engage with USDA regarding the proposed rule, we are reopening the comment period to receive new data, information, or further comments only on FDA-specific aspects of the proposed rule, including FDA's 13 general principles. Primary and Supporting Documents, as well as Comments, are accessible from Regulations.gov at: https://www.regulations.gov/docket?D=FDA-1995-N-0062. Proposed rule of 20 May 2005 (70 FR 29214): https://www.govinfo.gov/content/pkg/FR-2005-05-20/html/05-9958.htm https://www.govinfo.gov/content/pkg/FR-2005-05-20/pdf/05-9958.pdf DATES: We are reopening 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 21 April 2020.
Distribution date: 24 February 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 European Union would like to inform the WTO Members of the adoption of Commission Implementing Regulation (EU) 2020/25 of 13 January 2020 amending and correcting 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. This Commission Implementing Regulation does not add any new requirements, but clarifies that the Certificate of inspection should be issued by the Control Bodies before the consignment leaves the third country of origin or export, as already enshrined in Commission Implementing Regulation 1235/2008. The text of the Implementing Regulation is available at https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1581329223025&uri=CELEX:32020R0025 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 athttps://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
Distribution date: 13 February 2020
Products Covered: Agricultural and aquaculture products intended to be marketed as organic in the EU
Regulation Type: Addendum to Regular Notification
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