Proyecto de Decisión sobre registro y control de productos veterinarios, su Manual Técnico y Anexos, constituidos por las Guías de Inspección de los sistemas de calidad en las empresas de productos veterinarios (Draft Decision on the registration and control of veterinary products and the associated Technical Manual and the Annexes thereto, consisting of guides for the inspection of the quality systems of veterinary product companies) (229 pages, in Spanish)
Distribution date: 24 July 2023 | Final date for Comment: 22 September 2023
The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).
Products Covered: Veterinary products (Chapter 30 of the Harmonized System)
Regulation Type: Regular notification
Proyecto de Decisión sobre registro y control de productos veterinarios, su Manual Técnico y Anexos, constituidos por las Guías de Inspección de los sistemas de calidad en las empresas de productos veterinarios (Draft Decision on the registration and control of veterinary products and the associated Technical Manual and the Annexes thereto, consisting of guides for the inspection of the quality systems of veterinary product companies) (229 pages, in Spanish)
Distribution date: 24 July 2023 | Final date for Comment: 22 September 2023
The notified text concerns the registration and control of veterinary product companies and their technical officers. It addresses the modification, suspension, cancellation and renewal of their registration; companies' obligations; and the registration and control of veterinary products. The text also lays down the basic principles and requirements for the quality management systems of veterinary product companies (good manufacturing practices, good laboratory practices, good storage practices and biosecurity and bioprotection requirements).
Products Covered: Veterinary products (Chapter 30 of the Harmonized System)
Regulation Type: Regular notification
Reglamento para el Registro Sanitario Condicional de Medicamentos y Productos Biológicos (Regulation for the conditional sanitary registration of medicines and biological products)
Distribution date: 20 July 2023
The Regulation for the conditional sanitary registration of medicines and biological products has been approved pursuant to Supreme Decree No. 020-2023-SA and will enter into force six months after publication in the Official Journal, El Peruano. Moreover, Supreme Decree No. 002-2021-SA and the amendment thereto approved by Supreme Decree No. 019-2021-SA have been repealed. Ministerio de Comercio Exterior y Turismo, MINCETUR (Ministry of Foreign Trade and Tourism) Calle Uno Oeste Nº 50 - Urb. Corpac - Lima 27 - Peru Tel.: (+51-1) 513-6100, Ext. 1223 and 1239 Email: [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: PRODUCTOS FARMACÉUTICOS (HS code(s): 30); Productos farmacéuticos (ICS code(s): 11.120)
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., Positive pressure self-contained closed-circuit breathing Apparatus of Compressed Oxygen
Distribution date: 20 July 2023 | Final date for Comment: 18 September 2023
This document specifies the technical requirements, test methods, classification, inspection rules, marking, packaging, storage and transportation requirements for positive pressure self-contained closed-circuit compressed oxygen breathing apparatus and compressed oxygen-nitrogen breathing apparatus (hereinafter referred to as oxygen breathing apparatus).This document applies to self-contained closed-circuit compressed oxygen breathing apparatus and compressed oxygen-nitrogen breathing apparatus used in the positive pressure air supply mode.This document does not apply to negative pressure oxygen breathing apparatus, air breathing apparatus, diving breathing apparatus, escape oxygen breathing apparatus, compressed oxygen self-rescue apparatus and chemical oxygen breathing apparatus.
Products Covered: Positive pressure self-contained closed-circuit breathing apparatus of compressed oxygen (HS code(s): 9020); (ICS code(s): 13.340.30)
Regulation Type: Regular notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 20 July 2023
The proposed maximum residue limits (MRLs) for Isofetamid notified in G/SPS/N/JPN/1166 (dated 6 January 2023) were adopted and published on 31 May 2023.The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 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: 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10 and 07.13)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.02, 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)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.04, 12.05 and 12.07)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 20 July 2023
The proposed maximum residue limits (MRLs) for Methoxyfenozide notified in G/SPS/N/JPN/1167 (dated 6 January 2023) were adopted and published on 31 May 2023.The specified MRLs are available as below:
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: 07.02, 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, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Coffee, tea, mate and spices (HS codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS codes: 10.05 and 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.02, 12.07 and 12.12)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 20 July 2023
The proposed maximum residue limits (MRLs) for Pyriproxyfen notified in G/SPS/N/JPN/1168 (dated 6 January 2023) were adopted and published on 31 May 2023.The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.04, 02.05, 02.06 and 02.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.07, 07.08, 07.09, 07.10 and 07.13)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)Coffee, tea, mate and spices (HS codes: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.07)Animal fats and oils (HS codes: 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 20 July 2023
The proposed maximum residue limits (MRLs) for Mosapride notified in G/SPS/N/JPN/1169 (dated 6 January 2023) were adopted and published on 31 May 2023.The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.04, 02.05, 02.06 and 02.08)Dairy produce (HS code: 04.01)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)
Distribution date: 20 July 2023
The proposed maximum residue limits (MRLs) for Acequinocyl notified in G/SPS/N/JPN/1165 (dated 6 January 2023) were adopted and published on 31 May 2023.The specified MRLs are available as below:
Products Covered: Meat and edible meat offal (HS codes: 02.06 and 02.08)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.07, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS codes: 08.01, 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea, mate and spices (HS codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.05)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.07, 12.10 and 12.12)Animal fats and oils (HS codes: 15.02 and 15.06)
Regulation Type: Addendum to Regular Notification
Commission Implementing Regulation (EU) 2023/54 of 4 January 2023 correcting Implementing Regulation (EU) 2022/652 concerning the authorisation of bitter orange extract as a feed additive for certain animal species
Distribution date: 19 July 2023
The use of bitter orange extract as feed additive was authorised for certain animal species by Commission Implementing Regulation (EU) 2022/652. Bitter orange extract is known to contain 10 to 20% neohesperidin, as detailed in the column "Composition, chemical formula, description, analytical method" in the Annex to Implementing Regulation (EU) 2022/652. An incorrect presumption of a relationship between neohesperidin, identified with CAS number 13241-33-3, and neohesperidin dihydrochalcone, identified with CAS number 20702-77-6, which has a similar name but is a distinct substance, resulted in point 3 of the column "Other provisions" in the Annex to Implementing Regulation (EU) 2022/652, which mistakenly provides for the exclusion of the use of bitter orange extract in combination with neohesperidin dihydrochalcone. Commission Implementing Regulation (EU) 2023/54 corrects this mistake.
Products Covered: Preparation of a kind in animal nutrition
Regulation Type: Regular notification
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