Regulatory Updates
TITLE: Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS ACTION: Notification of availability SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labeling--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of 27 May 2016, entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labeling." Guidance is available for download on the FDA’s website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-revision-nutrition-and-supplement-facts-labels The announcement of the guidance is published in the Federal Register on 4 February 2020.
Distribution date: 05 February 2020
Products Covered: Food products, labeling
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 7 February 2012, the Government of the Republic of Nicaragua notified, in document G/TBT/N/HND/73, 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 draft applied to natural medicines for human use that are manufactured or imported by natural or legal persons for marketing in countries of the Central American region. It did 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: Secretaría de Desarrollo Económico (Secretariat for Economic Development) Dirección General de Integración Económica y Política Comercial (Directorate-General of Economic Integration and Trade Policy) Boulevard José Cecilio del Valle Edificio San José, 3er piso Fax: (+504) 2235-8383 or 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 (Agency for Sanitary Regulation) Dirección de Productos Farmacéuticos y Otros productos de Interés Sanitario (Directorate of Pharmaceutical Products and Other Products of Sanitary Interest) Calle Los Alcaldes, Frente al City Mall Email: consultapublica@arsa.gob.hn Website: http://www.arsa.gob.hn
Distribution date: 30 January 2020
Products Covered: ICS 11.120.10
Regulation Type: Addendum to Regular Notification
RTCA No. 75.02.43:06: Biofuels. Biodiesel (B100) and biodiesel blend stock for diesel fuel No. 2-D (motor vehicles). Specifications The Republic of Honduras hereby advises that the final date for comments concerning notification G/TBT/N/HND/40/Add.1, dated 3 December 2019, has been extended to 1 March 2020. Agency or authority designated to handle comments: National Notification Authority. Text(s) available from: National Notification Authority, National Enquiry Point Secretaría de Desarrollo Económico (Secretariat for Economic Development) Dirección General de Integración Económica y Política Comercial (Directorate-General of Economic Integration and Trade Policy) Boulevard José Cecilio del Valle Edificio San José, 3er piso Fax: (+504) 2235-8383 or 2235-5047 Email: gsalinas_sic@yahoo.com
Distribution date: 30 January 2020
Products Covered: International Classification for Standards (ICS) code 75.160.20
Regulation Type: Addendum to Regular Notification
Technical guide: Guide to the inspection of good laboratory practices for pharmaceutical quality control In connection with the draft Guide to the inspection/audit of good laboratory practices for pharmaceutical quality control, notified in document G/TBT/N/PER/53 dated 27 November 2013, the Republic of Peru hereby advises that it has issued the Technical guide: Guide to the inspection of good laboratory practices for pharmaceutical quality control pursuant to Ministerial Resolution No. 506-2019-SA, published in Official Journal El Peruano of 10 June 2019. Entry into force: as from the entry into force, on 24 July 2019, of Supreme Decree No 017-2018-SA approving the Manual of good laboratory practices for pharmaceutical quality control. http://www.mincetur.gob.pe/reglamentostecnicos http://extranet.comunidadandina.org/sirt/public/index.aspx http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2019/RM_506-2019-MINSA.pdf https://www.gob.pe/institucion/minsa/normas-legales/279163-506-2019-minsa
Distribution date: 15 January 2020
Products Covered: Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System and of the Customs Tariff) ;
Regulation Type: Addendum to Regular Notification
Draft Manual of good laboratory practices for pharmaceutical quality control In connection with the draft Manual of good laboratory practices for pharmaceutical quality control, notified in document G/TBT/N/PER/52 dated 27 November 2013, the Republic of Peru hereby advises that it has issued the Manual of good laboratory practices for pharmaceutical quality control pursuant to Supreme Decree No. 017-2018-SA, published in Official Journal El Peruano of 23 July 2018. Entry into force: within one year of the day following the publication of the Decree in Official Journal El Peruano. http://www.mincetur.gob.pe/reglamentostecnicos http://extranet.comunidadandina.org/sirt/public/index.aspx https://www.gob.pe/institucion/minsa/normas-legales/177924-017-2018-sa http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2018/DS_017-2018.pdf
Distribution date: 15 January 2020
Products Covered: Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products (classified under Chapter 30 of the Harmonized System and of the Customs Tariff). ;
Regulation Type: Addendum to Regular Notification
Products covered: ICS 29.140.99 (Other standards related to lamps) This addendum concerns the notification of the Ministerial Decree No.1095/2019 (2 pages, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 3939 "Lamp control gear particular requirements for a.c. supplied electronic control gear for fluorescent lamps" (184 pages, in English). It should be noted that the draft of this standard was formerly notified in G/TBT/N/EGY/3/Add.23 dated 18 September 2019, furthermore the Ministerial Decree No. 423/2005 (25 pages, in Arabic) which mandated among others the earlier version of this Standard, was formerly notified in G/TBT/N/EGY/3 dated 14 December 2005. Worth mentioning is that this standard adopts the technical content of IEC 61347‑2‑3:2011/AMD1:2016. 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: 29/11/2019 Proposed date of entry into force: 17/12/2019 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: 08 January 2020
Products Covered: Chemical, textile and engineering products
Regulation Type: Addendum to Regular Notification
Products covered: ICS 79.040 (Wood, sawlogs and sawn timber), ICS 79.060.10 (plywood) This addendum concerns the notification of the Ministerial Decree No.1095/2019 (2 pages, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 949-2"Plywood –part 2: Tolerances on dimensions " (8 pages, in Arabic). It should be noted that the draft of this standard was formerly notified in G/TBT/N/EGY/3/Add.22 dated 18 September 2019, furthermore the Ministerial Decree No. 423/2005 (25 pages, in Arabic) which mandated among others the earlier version of this Standard, was formerly notified in G/TBT/N/EGY/3 dated 14 December 2005. Worth mentioning is that this standard is technically identical with ISO 1954:2013 (confirmed in 2019). 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: 29/11/2019 Proposed date of entry into force: 17/12/2019 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: 08 January 2020
Products Covered: Chemical, textile and engineering products
Regulation Type: Addendum to Regular Notification
Products covered: Vegetables and derived products (ICS: 67.080.20) This addendum concerns the notification of the Ministerial Decree No.1097/2019 (1 page, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 1636 "table olives" (19 pages, in Arabic). It should be noted that Ministerial Decree No. 93/2013 (4 pages, in Arabic) which was formerly notified in G/TBT/N/EGY/34 dated 30 April 2013, mandated among others the earlier version of this Standard. Worth mentioning is that this standard is technically identical with CODEX STAN 66:1981 Revision: 1987, 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: 29/11/2019Proposed date of entry into force: 17/12/2019Agency 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: 07 January 2020
Products Covered: Food products
Regulation Type: Addendum to Regular Notification
Products covered: ICS 29.140.20 (Incandescent lamps) This addendum concerns the notification of the Ministerial Decree No.1095/2019 (2 pages, in Arabic) that gives the producers and importers a six-month transitional period to abide by the Egyptian Standard ES 27" Tungsten filament lamps for domestic and similar general lighting purposes – performance requirements" (58 pages, in English). It should be noted that the draft of this standard was formerly notified in G/TBT/N/EGY/3/Add.21 dated 18 September 2019, furthermore the Ministerial Decree No. 423/2005 (25 pages, in Arabic) which mandated among others the earlier version of this Standard, was formerly notified in G/TBT/N/EGY/3 dated 14 December 2005. Worth mentioning is that this standard adopts the technical content of IEC 60064:1993/AMD4:2007 and IEC 60064:1993/AMD5:2009. 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: 29/11/2019 Proposed date of entry into force: 17/12/2019 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: 07 January 2020
Products Covered: Chemical, textile and engineering products
Regulation Type: Addendum to Regular Notification
In connection with the draft Supreme Decree amending certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, notified in document G/TBT/N/PER/81 dated 2 October 2015, the Republic of Peru hereby advises that it has issued Supreme Decree No. 029-2015-SA, published in Official Journal El Peruano of 12 September 2015, which amends the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, as approved by Supreme Decree No. 016-2011-SA. Entry into force: the day following publication in Official Journal El Peruano. http://www.mincetur.gob.pe/reglamentostecnicos http://extranet.comunidadandina.org/sirt/public/index.aspx http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Normatividad/2015/DS_029-2015.pdf
Distribution date: 16 December 2019
Products Covered: ;Pharmaceutical products classified under Chapter 30 of the Harmonized System or Customs Tariff. ;Medical devices classified under headings of the Harmonized System or Customs Tariff. ;
Regulation Type: Addendum to Regular Notification
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