Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 13 January 2014 | Final date for Comment: 14 March 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Cyprodinil.
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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (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 and 07.13) - Edible fruits and nuts, peel of citrus/melons (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: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.05) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 13 January 2014 | Final date for Comment: 14 March 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Cyprodinil.
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) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (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 and 07.13) - Edible fruits and nuts, peel of citrus/melons (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: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.05) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 13 January 2014 | Final date for Comment: 14 March 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Molinate.
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - 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 fruits and nuts, peel of citrus/melons (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) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05,12.06, 12.07, 12.10 and 12.12) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

Distribution date: 13 January 2014 | Final date for Comment: 14 March 2014
Proposed maximum residue limits (MRLs) for the following agricultural chemicals: Pesticide: Molinate.
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06 and 03.07) - 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 fruits and nuts, peel of citrus/melons (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) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.04, 12.05,12.06, 12.07, 12.10 and 12.12) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Final rule: Importation of Fresh Apricots from Continental Spain (Docket No. APHIS-2011-0132)

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The Animal and Plant Health Inspection Service is amending the fruits and vegetables regulations to allow the importation into the United States of fresh apricots from continental Spain (excluding the Balearic Islands and Canary Islands). As a condition of entry, fresh apricots from continental Spain will have to be produced in accordance with a systems approach that includes registration of production locations and packinghouses, pest monitoring, sanitary practices, chemical and biological controls, and phytosanitary treatment. The fruit will have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to port of entry in the United States. Consignments will have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Spain certifying that the fruit is free from all quarantine pests and has been produced in accordance with the systems approach. This action will allow for the importation of fresh apricots from continental Spain while continuing to protect against the introduction of plant pests into the United States. Federal Register, Vol. 78, No. 251, Tuesday, 31 December 2013, pages 79573-79579. This notice is available in English at: http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0132-0011. On 30 January 2013, we published in the Federal Register (78 FR 6227-6232, Docket No. APHIS-2011-0132) a proposal (1) to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh apricots (Prunus armeniaca L.) (2) from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States. We proposed to allow the importation of fresh apricots from continental Spain only if they were produced in accordance with a systems approach jointly agreed upon in a bilateral workplan between the Animal and Plant Health Inspection Service (APHIS) and the national plant protection organization (NPPO) of Spain. The systems approach addresses four quarantine pests that the pest risk analysis (PRA) determined could follow the pathway of consignments of fresh apricots imported from continental Spain into the United States. We solicited comments concerning our proposal for 60 days ending 1 April 2013. We reopened and extended the deadline for comments until 13 June 2013, in a document published in the Federal Register on 29 May 2013 (78 FR 32184, Docket No. APHIS-2011-0132). We received four comments by that date.
Products Covered:
Regulation Type: Addendum to Regular Notification
Final rule: Importation of Fresh Apricots from Continental Spain (Docket No. APHIS-2011-0132)

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The Animal and Plant Health Inspection Service is amending the fruits and vegetables regulations to allow the importation into the United States of fresh apricots from continental Spain (excluding the Balearic Islands and Canary Islands). As a condition of entry, fresh apricots from continental Spain will have to be produced in accordance with a systems approach that includes registration of production locations and packinghouses, pest monitoring, sanitary practices, chemical and biological controls, and phytosanitary treatment. The fruit will have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to port of entry in the United States. Consignments will have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Spain certifying that the fruit is free from all quarantine pests and has been produced in accordance with the systems approach. This action will allow for the importation of fresh apricots from continental Spain while continuing to protect against the introduction of plant pests into the United States. Federal Register, Vol. 78, No. 251, Tuesday, 31 December 2013, pages 79573-79579. This notice is available in English at: http://www.regulations.gov/#!documentDetail;D=APHIS-2011-0132-0011. On 30 January 2013, we published in the Federal Register (78 FR 6227-6232, Docket No. APHIS-2011-0132) a proposal (1) to amend the regulations concerning the importation of fruits and vegetables to allow the importation of fresh apricots (Prunus armeniaca L.) (2) from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States. We proposed to allow the importation of fresh apricots from continental Spain only if they were produced in accordance with a systems approach jointly agreed upon in a bilateral workplan between the Animal and Plant Health Inspection Service (APHIS) and the national plant protection organization (NPPO) of Spain. The systems approach addresses four quarantine pests that the pest risk analysis (PRA) determined could follow the pathway of consignments of fresh apricots imported from continental Spain into the United States. We solicited comments concerning our proposal for 60 days ending 1 April 2013. We reopened and extended the deadline for comments until 13 June 2013, in a document published in the Federal Register on 29 May 2013 (78 FR 32184, Docket No. APHIS-2011-0132). We received four comments by that date.
Products Covered:
Regulation Type: Addendum to Regular Notification
Final rule: Importation of Avocados from Continental Spain (Docket No. APHIS-2012-0002)

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The Animal and Plant Health Inspection Service (APHIS) is amending the fruits and vegetables regulations to allow the importation of avocados from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States. As a condition of entry, avocados from Spain will have to be produced in accordance with a systems approach that includes registration of production locations and packinghouses, pest monitoring, sanitary practices, chemical and biological controls, and phytosanitary treatment. The fruit will have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to the port of entry in the United States. Consignments will have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Spain certifying that the fruit is free from all quarantine pests and has been produced in accordance with the systems approach. Consignments of avocados other than the Hass variety would also have to be treated for the Mediterranean fruit fly either prior to moving to the United States or upon arrival prior to release. This action will allow for the importation of avocados from continental Spain while continuing to protect against the introduction of plant pests into the United States. This notice is available in English at: http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0002-0031. Federal Register, Vol. 78, No. 251, Tuesday, 31 December 2013, pages 79568-79573. On 30 January 2013, the Animal and Plant Health Inspection Service (APHIS) published in the Federal Register (78 FR 6222-6227, Docket No. APHIS-2012-0002), a proposal to amend the fruits and vegetables regulations to allow the importation of avocados from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States subject to a systems approach and treatment. We proposed to allow the importation of avocados from continental Spain only if they were produced in accordance with a systems approach jointly agreed upon in a bilateral workplan between APHIS and the national plant protection organization (NPPO) of Spain. The systems approach addresses one pest of quarantine significance present in continental Spain that could be introduced into the United States through the importation of avocados. That pest is Ceratitis capitata (Wiedemann), the Mediterranean fruit fly. We solicited comments concerning our proposal for 60 days ending 1 April 2013. We reopened and extended the deadline for comments until 13 June 2013, in a document published in the Federal Register on 29 May 2013 (78 FR 32183-32184, Docket No. APHIS-2012-0002). We received 20 comments by that date.
Products Covered:
Regulation Type: Addendum to Regular Notification
Final rule: Importation of Avocados from Continental Spain (Docket No. APHIS-2012-0002)

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The Animal and Plant Health Inspection Service (APHIS) is amending the fruits and vegetables regulations to allow the importation of avocados from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States. As a condition of entry, avocados from Spain will have to be produced in accordance with a systems approach that includes registration of production locations and packinghouses, pest monitoring, sanitary practices, chemical and biological controls, and phytosanitary treatment. The fruit will have to be imported in commercial consignments, with each consignment identified throughout its movement from place of production to the port of entry in the United States. Consignments will have to be accompanied by a phytosanitary certificate issued by the national plant protection organization of Spain certifying that the fruit is free from all quarantine pests and has been produced in accordance with the systems approach. Consignments of avocados other than the Hass variety would also have to be treated for the Mediterranean fruit fly either prior to moving to the United States or upon arrival prior to release. This action will allow for the importation of avocados from continental Spain while continuing to protect against the introduction of plant pests into the United States. This notice is available in English at: http://www.regulations.gov/#!documentDetail;D=APHIS-2012-0002-0031. Federal Register, Vol. 78, No. 251, Tuesday, 31 December 2013, pages 79568-79573. On 30 January 2013, the Animal and Plant Health Inspection Service (APHIS) published in the Federal Register (78 FR 6222-6227, Docket No. APHIS-2012-0002), a proposal to amend the fruits and vegetables regulations to allow the importation of avocados from continental Spain (excluding the Balearic Islands and Canary Islands) into the United States subject to a systems approach and treatment. We proposed to allow the importation of avocados from continental Spain only if they were produced in accordance with a systems approach jointly agreed upon in a bilateral workplan between APHIS and the national plant protection organization (NPPO) of Spain. The systems approach addresses one pest of quarantine significance present in continental Spain that could be introduced into the United States through the importation of avocados. That pest is Ceratitis capitata (Wiedemann), the Mediterranean fruit fly. We solicited comments concerning our proposal for 60 days ending 1 April 2013. We reopened and extended the deadline for comments until 13 June 2013, in a document published in the Federal Register on 29 May 2013 (78 FR 32183-32184, Docket No. APHIS-2012-0002). We received 20 comments by that date.
Products Covered:
Regulation Type: Addendum to Regular Notification
Proyecto de Decreto Supremo que Modifica Artículos del Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Draft Supreme Decree amending certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products) (9 pages, in Spanish) ;

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The notified draft Supreme Decree contains three articles, three final supplementary provisions, four transitional supplementary provisions and one repealing supplementary provision which amend the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, approved by Supreme Decree No. 016-2011-SA and amended by Supreme Decree No. 001-2012-SA, with a view to making the implementation of the regulations and Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products) more viable. ; ;
Products Covered: Pharmaceutical products (HS 30); perfumes and toilet waters (HS 3303); beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or suntan preparations; manicure or pedicure preparations (HS 3304); preparations for use on the hair (HS 3305); soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS 3401); organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01 (HS 3402); -- of a kind used in the textile or like industries (HS 380991); toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width not exceeding 36 cm, or cut to size or shape; handkerchiefs, cleansing tissues, towels, tablecloths, serviettes, napkins and napkin liners for babies, sanitary towels (pads) and tampons, bed sheets and similar household, sanitary or hospital articles, articles of apparel and clothing accessories (HS 4818); wadding of textile materials and articles thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps (HS 5601); instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments (HS 9018); mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus (HS 9019); orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability (HS 9021); apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like (HS 9022); medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles (HS 9402). ;Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products classified under Chapter 30 of the Harmonized System or Customs Tariff. ;Medical devices classified under headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff. ;Sanitary products: cosmetics, domestic hygiene products and absorbent personal hygiene products classified under the following headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601. ;
Regulation Type: Regular notification
Proyecto de Decreto Supremo que Modifica Artículos del Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Draft Supreme Decree amending certain articles of the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products) (9 pages, in Spanish) ;

Distribution date: 13 January 2014 | Final date for Comment: 07 May 2025
The notified draft Supreme Decree contains three articles, three final supplementary provisions, four transitional supplementary provisions and one repealing supplementary provision which amend the regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products, approved by Supreme Decree No. 016-2011-SA and amended by Supreme Decree No. 001-2012-SA, with a view to making the implementation of the regulations and Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products) more viable. ; ;
Products Covered: Pharmaceutical products (HS 30); perfumes and toilet waters (HS 3303); beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or suntan preparations; manicure or pedicure preparations (HS 3304); preparations for use on the hair (HS 3305); soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS 3401); organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01 (HS 3402); -- of a kind used in the textile or like industries (HS 380991); toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width not exceeding 36 cm, or cut to size or shape; handkerchiefs, cleansing tissues, towels, tablecloths, serviettes, napkins and napkin liners for babies, sanitary towels (pads) and tampons, bed sheets and similar household, sanitary or hospital articles, articles of apparel and clothing accessories (HS 4818); wadding of textile materials and articles thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps (HS 5601); instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments (HS 9018); mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus (HS 9019); orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability (HS 9021); apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like (HS 9022); medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles (HS 9402). ;Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products classified under Chapter 30 of the Harmonized System or Customs Tariff. ;Medical devices classified under headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff. ;Sanitary products: cosmetics, domestic hygiene products and absorbent personal hygiene products classified under the following headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601. ;
Regulation Type: Regular notification
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