Derogatoria Reglamento Técnico RTE INEN 020 (1R) "FÓSFOROS" (Repeal of the first revision (1R) of Ecuadorian Standardization Service Technical Regulation (RTE INEN) No. 020 "Matches")

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Distribution date: 17 March 2022 | Final date for Comment: 07 May 2025

RTE INEN No. 020 "Matches" The Republic of Ecuador hereby advises that RTE INEN No. 020 "Matches", notified in document G/TBT/N/ECU/15/Add.2 of 7 April 2014, has been suspended and declared null and void. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Jeannette Mariño Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected][ mailto:[email protected] ] [email protected] [email protected][ mailto:[email protected] ] [email protected] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.

Products Covered: HS tariff subheading 360

Regulation Type: Addendum to Regular Notification

Revision of the Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards)

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Distribution date: 14 March 2022 | Final date for Comment: 07 May 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Sulfoxaflor.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Animal originated products (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) - Mate and spices (HS Codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Codes: 12.01, 12.05, 12.07 and 12.12) - Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06) - Cocoa (HS Code: 18.01)

Regulation Type: Regular notification

Human health Pesticides Food safety Maximum residue limits (MRLs)

Retiro del Proyecto de Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 020 (2R) "Fósforos" (Withdrawal of the draft second revision (2R) of Ecuadorian Standardization Service Technical Regulation (PRTE INEN) No. 020 "Matches")

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Distribution date: 17 March 2022 | Final date for Comment: 07 May 2025

PRTE INEN No. 020 "Matches" The Republic of Ecuador hereby advises that the draft second revision of PRTE INEN No. 020 "Matches", notified in document G/TBT/N/ECU/359 of 11 February 2019, has been suspended and declared null and void. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Jeannette Mariño Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected][ mailto:[email protected] ] [email protected] [email protected][ mailto:[email protected] ] [email protected] [email protected][ mailto:[email protected] ] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.

Products Covered: Matches (excl. pyrotechnic articles of heading 3604) (HS code(s): 3605); (ICS code(s): 97.180)

Regulation Type: Addendum to Regular Notification

Retiro del Proyecto de Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 020 (2R) "Fósforos" (Withdrawal of the draft second revision (2R) of Ecuadorian Standardization Service Technical Regulation (PRTE INEN) No. 020 "Matches")

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Distribution date: 17 March 2022 | Final date for Comment: 07 May 2025

PRTE INEN No. 020 "Matches" The Republic of Ecuador hereby advises that the draft second revision of PRTE INEN No. 020 "Matches", notified in document G/TBT/N/ECU/359 of 11 February 2019, has been suspended and declared null and void. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Jeannette Mariño Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected][ mailto:[email protected] ] [email protected] [email protected][ mailto:[email protected] ] [email protected] [email protected][ mailto:[email protected] ] (1) This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained.

Products Covered: Matches (excl. pyrotechnic articles of heading 3604) (HS code(s): 3605); (ICS code(s): 97.180)

Regulation Type: Addendum to Regular Notification

Administrative Measures for Health Quarantine Access of High-risk Special Products

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Distribution date: 29 March 2022 | Final date for Comment: 28 May 2022

These measures apply to the quarantine access management of high-risk special products that contain or may contain pathogenic microorganisms, including initial access application and application for resuming after suspension. These measures clarify the authority in charge and access applicants, specify the access procedures, including access application, questionnaire survey, risk assessment, result notification, etc., and specify the supervision and administration of the General Administration of Customs on quarantine access of special products. 

Products Covered: High-risk special products HS 3002; HS 3822; HS 2934; HS 3001  (Part of the products in these four HS codes)

Regulation Type: Regular notification

Administrative Measures for Health Quarantine Access of High-risk Special Products

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Distribution date: 29 March 2022 | Final date for Comment: 28 May 2022

These measures apply to the quarantine access management of high-risk special products that contain or may contain pathogenic microorganisms, including initial access application and application for resuming after suspension. These measures clarify the authority in charge and access applicants, specify the access procedures, including access application, questionnaire survey, risk assessment, result notification, etc., and specify the supervision and administration of the General Administration of Customs on quarantine access of special products. 

Products Covered: High-risk special products HS 3002; HS 3822; HS 2934; HS 3001  (Part of the products in these four HS codes)

Regulation Type: Regular notification

Draft MOPH Notification, B.E..., entitled "Enzymes for Food Processing"

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Distribution date: 31 March 2022 | Final date for Comment: 30 May 2022

Since the MOPH Notification No. 409 (BE. 2562) issued by virtue of the Food Act B.E. 2522 entitled “Enzyme for use in Food Processing” has been published, there are certain ambiguities in the application of this notification. In order to remove the such ambiguities, the MOPH notification shall be revised.By the virtue of the articles 5 and 6(6) of the Food Act of B.E.2522, the MOPH has issued the (draft) MOPH Notification which can be summarized as follow:1. The MOPH notification No. 409 (BE. 2562) issued by virtue of the Food Act B.E. 2522 entitled “Enzyme for use in Food Processing” of 9 July BE. 2562 will be repealed and replaced with this draft of MOPH Notification.2. Based on the MOPH notification No. 409 (BE. 2562), there are certain requirements that are currently prescribed in this draft of the MOPH notification:2.1 Requirement regarding mycotoxin and novel DNA are added to the general specification for food enzyme:·         In case of food enzyme originated from fungi, mycotoxin should not be detected.·         In case of food enzyme originated from genetically modified organisms, novel DNA or gene materials which are the results of the use of gene technology shall not be detectable.2.2 A material which is used for immobilized enzyme shall not release toxic substances into food by reference to the migrati0on limit set out in the MOPH notification on plastic food packaging.2.3 Enzymes, source of enzymes, functions and conditions of use are revised as appear in Annex I.2.4 Silicon dioxide, D-glucitol syrup and sorbitol syrup are added to Annex IV, food additive used in enzyme preparation.2.5 Enzymes used in the production of food additives and production of processing aids are also excluded from this draft of the MOPH notification.3. This notification shall enter into force after the date of its publication in the Government Gazette.This regulation has been notified as SPS Notification.

Products Covered: Food Enzyme, Processing Aids, Food Additives (HS code : 3507)

Regulation Type: Regular notification

Draft MOPH Notification, B.E..., entitled "Enzymes for Food Processing"

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Distribution date: 31 March 2022 | Final date for Comment: 30 May 2022

Since the MOPH Notification No. 409 (BE. 2562) issued by virtue of the Food Act B.E. 2522 entitled “Enzyme for use in Food Processing” has been published, there are certain ambiguities in the application of this notification. In order to remove the such ambiguities, the MOPH notification shall be revised.By the virtue of the articles 5 and 6(6) of the Food Act of B.E.2522, the MOPH has issued the (draft) MOPH Notification which can be summarized as follow:1. The MOPH notification No. 409 (BE. 2562) issued by virtue of the Food Act B.E. 2522 entitled “Enzyme for use in Food Processing” of 9 July BE. 2562 will be repealed and replaced with this draft of MOPH Notification.2. Based on the MOPH notification No. 409 (BE. 2562), there are certain requirements that are currently prescribed in this draft of the MOPH notification:2.1 Requirement regarding mycotoxin and novel DNA are added to the general specification for food enzyme:·         In case of food enzyme originated from fungi, mycotoxin should not be detected.·         In case of food enzyme originated from genetically modified organisms, novel DNA or gene materials which are the results of the use of gene technology shall not be detectable.2.2 A material which is used for immobilized enzyme shall not release toxic substances into food by reference to the migrati0on limit set out in the MOPH notification on plastic food packaging.2.3 Enzymes, source of enzymes, functions and conditions of use are revised as appear in Annex I.2.4 Silicon dioxide, D-glucitol syrup and sorbitol syrup are added to Annex IV, food additive used in enzyme preparation.2.5 Enzymes used in the production of food additives and production of processing aids are also excluded from this draft of the MOPH notification.3. This notification shall enter into force after the date of its publication in the Government Gazette.This regulation has been notified as SPS Notification.

Products Covered: Food Enzyme, Processing Aids, Food Additives (HS code : 3507)

Regulation Type: Regular notification

Normative Instruction number 122, 09 March 2022

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Distribution date: 04 April 2022 | Final date for Comment: 07 May 2025

This Normative Instruction contains provisions on inspection procedures in Good Clinical Practice for clinical trials with drugs.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Normative Instruction number 122, 09 March 2022

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Distribution date: 04 April 2022 | Final date for Comment: 07 May 2025

This Normative Instruction contains provisions on inspection procedures in Good Clinical Practice for clinical trials with drugs.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

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