Regulations on the sanitary control of pharmaceutical products and other products of sanitary interest and related establishments The Republic of Honduras hereby advises that the final date for comments concerning notification G/TBT/N/HND/95, dated 2 April 2019, has been extended to 30 June 2019. Agency or authority designated to handle comments: National Notification Authority. Text(s) available from: National Notification Authority, National Enquiry Point. Address, fax number and email address (if available) of other body: Agencia de Regulación Sanitaria, ARSA (Agency for Sanitary Regulation) Dirección de Alimentos y Bebidas (Food and Beverage Directorate) Calle Los Alcaldes, Frente al City Mall Email: [email protected] Website: http://www.arsa.gob.hn/ 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: [email protected] / [email protected]

Distribution date: 04 June 2019 | Final date for Comment: 03 May 2025
Products Covered: ICS 11.120.01
Regulation Type: Addendum to Regular Notification
Draft resolution number 649, 21 May 2019, regarding the active ingredient C63 – LAMBDA-CIALOTRINA of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient C63 – LAMBDA-CIALOTRINA from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - changes the MRL of the soya culture from 0.05 to 0.15 mg/kg and mantains the safety security period of 20 days.
Products Covered: HS Code(s): 120100; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 650, 21 May 2019, regarding the active ingredient F36 – FLUTRIAFOL of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient F36 – FLUTRIAFOL (fenpropimorph) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and use(application) on soil: - changes the MRL from 0.05 from 0.09 mg/kg for the coffee culture and mantains the safety security period of 120 days.
Products Covered: HS Code(s): 09; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 651, 21 May 2019, regarding the active ingredient P34 – PIRIPROXIFEM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient P34 – PIRIPROXIFEM from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers: - includes cane sugar culture with MRL of 0.01 mg/kg and safety security period of 210 days;- includes pasture for "non-food use", therefore there are not definition of LMR nor safety security period.
Products Covered: HS Code(s): 170111; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 648, 21 May 2019, regarding the active ingredient E19 - ETOFENPROXI of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient E19 - ETOFENPROXI from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes passion fruit and papaya culture with MRL of 0.3 mg/kg and safety security period of 1 day;- includes paprika, eggplant, scarlet eggplant, pepper and okra culture with MRL of 0.7 mg/kg and safety security period of 1 day.
Products Covered: HS Code(s): 070930, 070960, 080720, 09041, 08109090, 07, 07099990; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 646, 21 May 2019, regarding the active ingredient B26 – Bifentrina of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient B26 – BIFENTRINA from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes coconut culture with MRL of 0.05 mg/kg and safety security period of 7 days.
Products Covered: HS Code(s): 08011; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution number 647, 21 May 2019, regarding the active ingredient A29 – ACETAMIPRIDO of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019
This Draft resolution incorporates the following changes for the active ingredient A29 – ACETAMIPRIDO from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes passion fruit culture with MRL of 0.01 mg/kg and safety security period of 28 days; - changes the MRL from 0.5 to 0.7 mg/kg for fruits of the genus Capsicum or of the genus Pimenta, egg-plant, scarlet eggplant, pepper and okra cultures and safety security period from 3 days to 1 day.
Products Covered: HS Code(s): 070930, 09041, 070960, 08109090, 07099990, 07 ; ICS Code(s): 13, 65
Regulation Type: Regular notification
Draft resolution (Consulta Publica) number 640, 21 May 2019. Published on D.O.U, 22 May 2019, page 63. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=47527

Distribution date: 06 June 2019 | Final date for Comment: 12 July 2019
This draft resolution proposes to change the expiration date of the market registration for risk II sanitizing products to 10 (ten) years for the register of sanitizing products with Risk II and also changes the resolution – RDC number 42, 13 August 2009.
Products Covered: HS Codes: 3402; 340119; 340120; 330290 (sanitizing products).
Regulation Type: Regular notification
Proyecto de Primera Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 088 (1R) "Detergentes y jabones" (Draft first revision (1R) of Ecuadorian Technical Regulation PRTE INEN No. 088 "Detergents and soaps") (12 pages, in Spanish)

Distribution date: 06 June 2019 | Final date for Comment: 05 August 2019
The notified Ecuadorian Technical Regulation establishes the requirements concerning the maximum levels of phosphorus and minimum percentage of ultimate aerobic biodegradability to be met by surface tension agents found in detergents and soaps intended for household or industrial use, prior to the marketing of domestic and imported products, with the aim of protecting the environment and preventing deceptive practices. It applies to the following products for household or industrial use: · detergents · soaps It does not apply to: · products which claim to have cosmetic properties and a therapeutic purpose · products for veterinary use
Products Covered: - Soap and organic surface- Active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent: (HS code(s): 34011); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Surface-active preparations, washing preparations, auxiliary washing preparations and cleaning preparations put up for retail sale (excl. organic surface-active agents, soap and organic surface-active preparations in the form of bars, cakes, moulded pieces or shapes, and products and preparations for washing the skin in the form of liquid or cream) (HS code(s): 340220); Surface-active preparations, washing preparations, incl. auxiliary washing preparations and cleaning preparations (excl. those put up for retail sale, organic surface-active agents, soap and organic surface-active preparations in the form of bars, cakes, moulded pieces or shapes, and products and preparations for washing the skin in the form of liquid or cream) (HS code(s): 340290); (ICS code(s): 71.100.40)
Regulation Type: Regular notification
Resolution - RDC number 283, 17 May 2019. Published on D.O.U, 22 May 2019, pages 61-62.

Distribution date: 06 June 2019 | Final date for Comment: 03 May 2025
This resolution establishes technical requirements for investigation, control and elimination of nitrosamines potentially carcinogenic in active pharmaceutical ingredients (IFA) which are angiotensin II receptor antagonists; and is applied to companies that manufacture, import and fractionate active pharmaceutical ingredients (IFA).
Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)
Regulation Type: Regular notification
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