Regulatory Updates

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:

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Distribution date: 30 March 2020

Products Covered: Fermented acetic products.

Regulation Type: Addendum to Regular Notification

Food standards

Turkish Food Codex Regulation on Food Additives

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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

Modification of content/scope of regulation Food additives Human health Labelling Food safety

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.

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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

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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.

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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

Food standards

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

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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

Organic agriculture Food standards Labelling

On 3 February 2012, the Government of the Republic of Guatemala notified, in document G/TBT/N/GTM/77, draft Central American Technical Regulation (RTCA) No. 11.03.64:11: "Pharmaceutical products. Natural medicines for human use. Sanitary registration requirements". The description of content stated that the purpose of the draft was to establish the conditions and requirements for the sanitary registration of natural medicines for human use intended for marketing. The Technical Regulation applies to natural medicines for human use that are manufactured or imported by natural or legal persons for marketing in the Central American region. It 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. The purpose of the present Addendum is to notify WTO Members that this Technical Regulation has been updated and that there will be a comment and observation period of 60 days as from the date of this notification. The relevant text is available online at: Website: www.mineco.gob.gt Coordinación de Integración Económica (Economic Integration Coordination Office) 8ª. Ave. 10-43, Zona 1, 4to. Nivel Ciudad de Guatemala Guatemala Tel.: (+502) 2412 0200, Ext. 4319 Fax: (+502) 2412 0339 Email: ljuarez@mineco.gob.gt

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Distribution date: 10 February 2020

Products Covered: Medicaments (ICS code(s): 11.120.10)

Regulation Type: Addendum to Regular Notification

Human health

Products covered: ICS: 23.060.40 (Pressure regulators) This addendum concerns the notification of Draft of the Egyptian Standard ES 4749"Pressure regulators, automatic change-over devices, having a maximum regulated pressure of 4 bar, with a maximum capacity of 150 kg/h, associated safety devices and adaptors for butane, propane, and their mixtures" (141 Pages, In English). It should be noted that the Ministerial Decree No. 423/2005 (25pages, in Arabic) which was formerly notified in G/TBT/N/EGY/3 dated 14 December 2005 mandated among others the earlier version of this Standard. Worth mentioning is that this draft Standard adopts the technical content of EN 16129:2013 Producers and importers are kept informed of any amendments in the Egyptian standard 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 PointEgyptian 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

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Distribution date: 06 February 2020

Products Covered: Chemical, textile and engineering products

Regulation Type: Addendum to Regular Notification

Products covered: ICS 75.160.10 (Solid fuels)   This addendum concerns the notification of Draft of the Egyptian standard ES 1592 “Solid mineral fuels- Determination of ash "(9 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 draft standard is technically identical with ISO 1171/2010 (confirmed 2016) Producers and importers are kept informed of any amendments in the Egyptian standard 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 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

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Distribution date: 06 February 2020

Products Covered: Chemical, textile and engineering products

Regulation Type: Addendum to Regular Notification

Products covered: ICS 87.040 (Paints and varnishes) This addendum concerns the notification of Draft of the Egyptian standard ES 1539-1 “Paints and varnishes - Water-borne coating materials and coating systems for interior walls and ceilings - Classification "(12 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 draft standard is technically identical with EN 13300:2001/AC:2002 Producers and importers are kept informed of any amendments in the Egyptian standard 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 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

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Distribution date: 06 February 2020

Products Covered: Chemical, textile and engineering products

Regulation Type: Addendum to Regular Notification

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