Regulatory Updates
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
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
Distribution date: 10 February 2020
Products Covered: Medicaments (ICS code(s): 11.120.10)
Regulation Type: Addendum to Regular Notification
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
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
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
Distribution date: 06 February 2020
Products Covered: Chemical, textile and engineering products
Regulation Type: Addendum to Regular Notification
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
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