Notifications for Republic of Korea (388 notifications)
The proposed amendment seeks to: 1. Clarify the review procedure and the scope of the document for safety assessment of stacked events;2. Clarify the subject and the document for the renewal of authorizations;3. Notify change in the format of application (application for safety assessment etc.).
The Republic of Korea is proposing to amend the "Temporary Standards & Specifications for Food and Food Additives": 1. Change the fee for safety assessment of food additives derived from genetically modified microorganism; 2. Extend the processing period for item change application of safety assessment result notice of food additives derived from genetically modified microorganism.
The proposed amendments seek to: 1. Require manufacturer to follow Good Manufacturing Practice (GMP); 2. Clarify the list of ingredients approved to be used in enteric capsule, granule, tablet; 3. Expand the scope of approved ingredients can be mixed into semi-processed products to include oils and fats; 4. Establish standards of lead and cadmium in functional ingredients whose standards are not established; 5. Revise expression in standards and specifications "A~B" to "more than A and less than B"; 6. Establish standards for acid value and peroxide value in "Edible Oil contain EPA and DHA"; 7. Amend the name of a functional ingredient: - Change "Lutein" to "Tagetes erecta Extract"; 8. Revise test methods for functional ingredients (Ginsenoside).
The proposed amendment seeks to: 1. Revise the "Ingredients Approved for Use in Food" and "Ingredients Approved for Limited Use in Food" lists as follows: - Use condition for Wilford's swallow-wort (Cynanchum wilfodii (Maxim.) Hemsl.) is established to allow only the water extract of tuberous root of Wilford's swallow-wort to be used in food. - The names of food ingredients are revised and duplicated food ingredients are combined for clarification. - Six fishery products and four microorganisms are added to "Ingredients Approved for Use in Food" list or "Ingredients Approved for Limited Use in Food" list. 2. Revise the Preservation and Distribution Standards for "Other processed fish meat products" with low moisture; several types of "Beverages"; and frozen products which are transported by delivery service. 3. Establish the food type, manufacturing/processing standards and acid value standard, etc. of "Fish oil". 4. Revise the microbiological limits for several food types as follows: - Bacteria count limits for "Coffee" and "Other foods for infants/young children". - Cronobacter spp. limit for foods for infants/young children. 5. Establish and revise the maximum residual limits (MRLs) for pesticides in agricultural products as follows: - MRLs for 78 pesticides, including Deltamethrin, are revised or newly established. - MRLs for 237 unregistered pesticides are indicated as provisional MRLs.6. Revise the "General Test Methods".
The proposed amendments mainly focus on the following: Adding "the criteria of evaluation of safety and efficacy for animal cellular and gene therapy products."
The Republic of Korea is proposing to amend the "Standards and Specifications for Food Utensils, Containers and Packages": 1) The standards and specifications of the following synthetic resin are revised or newly established: Hydroxybutyl polyester, hydroxybenzoic acid polyester, butylenesuccinate-adipate copolymer (PBSA) and butylenesuccinate copolymer (PBS); 2) The test methods or the wording are revised; 3) The reexamination period of regulations are revised.
- In accordance with the notification G/SPS/N/KOR/543, the classification of livestock in the Standards and Specifications for Livestock is merged into the Standards and Specifications for Food. While names and specifications of some products in the Standards and Specifications for Food have been changed, their import approvals have not been affected by the changes in the Standards and Specifications for Food. - Provisions related to prohibition of importation and lift of import restriction due to animal diseases will be deleted as they are stipulated in "Region Prohibited for Import of Designated Quarantine Objects" by the "Act on the Prevention of Contagious Animal Diseases". - Both "Countries (Regions) Allowed for Import of Livestock Products and Import Sanitation Requirements" and the "Act on the Prevention of Contagious Animal Diseases" will be required for approval of livestock export. - The list of countries and products allowed to be imported to Korea is updated (e.g., Portuguese poultry and Brazilian pork, etc.).
The Republic of Korea is proposing to amend the "Standards and Specifications for the Food Additives". 1) The standards and specifications of the following food additive are newly established: Calcium dihydrogen pyrophosphate; 2) The list of boiler water additives used in the preparation of steam that will contact food during food manufacturing process is established; 3) The test methods or the specifications of following 18 food additives are revised: Dry formed vitamin A, smoke flavours, steviol glycoside, sodium stearoyl lactylate, spirulina color, amidated pectin, ester gum, ethyl vanillin, eugenol, eucalyptol, isoeugenol, polyvinyl acetate, caffeine, pectinase; 4) The standards for the use of the following three food additives are revised: Sodium saccharin, zinc sulfate, nitrogen (liquid type); 5) The wording of standards for use of the following 134 food additives is revised: Magnesium silicate, calcium silicate, persimmon color, kaoliang color, manganese gluconate, zinc gluconate, gold leaf, lavor color, natamycin, neotame, nicotinic acid, nicotinamide, sodium dehydroacetate, copper chlorophyll, sodium copper chlorophyllin, potassium copper chlorophyllin, BHT, sodium lauryl sulfate, lac color, rutin, tagetes extract, sodium metasilicate, sodium metabisulfite, potassium metabisulfite, propyl gallate, morpholine salts of fatty acids, hibiscus color, sulfur dioxide, berries color, BHA, sodium fluoride, beet red, sodium saccharin, saffron color, sodium bisulfite, sodium selenate, sorbic acid, potassium sorbate, calcium sorbate, hydrogen, water soluble annatto, sucralose, smoke flavour, steviol glycoside, sodium stearoyl lactylate, spirulina color, L-cysteine monohydrochloride, shea nut color, Fast green FCF and its aluminium lake, amaranth and its aluminium lake, erythrosine, allura red and its aluminium lake, ponceau 4R, brilliant blue FCF and its aluminium lake, indigocarmine and its aluminium lake, tartrazine and its aluminium lake, sunset yellow FCF and its aluminium lake, turmeric oleoresin, acesulfame potassium, sodium selenite, L-ascorbyl palmitate, L-ascorbyl stearate, sodium nitrite, β-apo-8'-carotenal, sodium sulfite, annatto extract, benzoic acid, sodium benzoate, potassium benzoate, calcium benzoate, alfalfa extract, onion color, ozone water, sepia color, oxystearin, EDTA·2Na, EDTA·Ca·2Na, silicon dioxide, chlorine dioxide, titanium dioxide, isopropyl alcohol, sodium diacetate, sandalwood red, purple sweet potato color, maize morado color, purple yam color, red radish color, red cabbage color, sodium nitrate, potassium nitrate, sodium hypochlorite, hypochlorous acid water, calcium hypochlorite, sodium hydrosulfite, perilla color, sodium iron chlorophyllin, polyvinyl acetate, gardenia red, gardenia blue, gardenia yellow, caramel color, carotene, beta carotene, carmine, cacao color, cochineal extract, chlorophyll, tamarind color, TBHQ, tomato color, methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, oleoresin paprika, phaffia color, grape juice color, grape skin color, polyethylene color, propionic acid, sodium propionate, calcium propionate, propylene glycol, pecan nut color, spice oleoresins, monascus color, monascus yellow, carthamus red, carthamus yellow, zinc sulfate, enzymatically modified stevia.
The proposed amendments seek to: 1. Allow to apply standards and specifications of Codex Alimentarius or other advanced countries to vitamin/mineral supplement ingredients when they are listed in Health Functional Food Code but their corresponding specifications are not established in Food Code & Food Additives Code; 2. Amend minimum daily intake of Vitamin D and Chrome in accordance with the revised Nutrient Reference Value; 3. Add new clauses in standards for manufacturing of Iron and folic acid; 4. Add a more detailed warning notice for intake of edible oil containing gamma-linolenic acid; 5. Add amended test methods for 12 functional food ingredients.
The proposed amendment seeks to: Revise the list of "Classification of Raw Food Materials": - Classify "Sablefixh, Black cod (Anoplopoma fimbria)" as abyssal fishes; Revise the list of "Pesticide ingredients exempted from the establishment of maximum residue limits"; Revise the word "Manufacturer" to "Food manufacturer or processor, and livestock products processor"; Adopt quantitative concepts for the specification of food poisoning bacteria (Clostridium perfringens and Staphylococcus aureus Revise the manufacturing and processing standards for "Brewed vinegar" to permit the use of "Oak wood chip" with the purpose of flavouring; Revise the list of "Raw materials approved for use in foods" and "Raw materials approved for limited use in foods": - Permit use of "Sword bean (Canavalia gladiatia) pod" as food raw material; - Clarify the edible part of "Aloe barbadensis (Aloe vera (L.) Burm. f.)"; - Clarify the requirement for "Velvet bean (Mucuna pruriens)" use; Establish and revise the maximum residue limits for 105 pesticides (Iminoctadin, Daminozide, Metalaxyl, etc.) in agricultural and livestock products; Establish and revise the maximum residue limits for 18 veterinary drugs (Gentamicin, Nicarbazin, Neomycin, etc.) in livestock products.
The proposed amendment seeks to: Establish the specifications (non-detection) for five food poisoning viruses in water for food: - Hepatitis A and B virus, Rotavirus, Enteric adenoviridae, Sapovirus; Establish and revise the maximum limits for heavy metals (lead, cadmium) in agricultural products and fishery products: - Lead: Apple, Mandarin, Berries (0.2→0.1); Perilla seed (0.3); Bellflower root, Deodeok root (0.2→0.1); Squid (1.0); Crustacean (1.0→0.5); Sea mustard (0.1); - Cadmium: Bellflower root (0.2→0.1); Squid (1.5); Sea mustard (0.1); Revise the application criteria of maximum residue limits for pesticides according to the entire adoption of positive list system; Establish the maximum limit for histamine in Japanese amberjack, Yellowtail (Seriola quinqueradiata Add two newly indentified analogues of anti-impotence drug and five medicinal ingredients to the list of "Substances that shall be not detected in food": - Analogues of anti-impotence drug: Isopropylnortadalafil, Descarbonsildenafil; - Medicinal ingredients: Phenolphthaleine, Yohimbine, Icarine, Sennoside, Cascaroside; Revise the definition and the manufacturing and processing standards for "Sesame seed oil' and ‘Perilla seed oil"; Delete endangered spices from the list of "Raw materials approved for use in foods": - Silky shark (Carcharhinus falciformis), Porbeagle, Beaumaris shark, Porbeagle (Lamna nasus), Oceanic whitetip shark (Carcharhinus longimanus Establish and revise the maximum residue limit for 110 pesticides (Iminoctadine, Norflurazon, Deltamethrin, etc.).
The Republic of Korea is proposing to amend the "Enforcement Rule of Special Act on Imported Food Safety Control". The amendment includes the following: If halal attestation is included in an export health certificate, a separate copy of halal certificate will not be required to be submitted; In addition to the export health certificate in paper form, Korea will also recognize electronic version of export health certificate submitted by an exporting government via communication network; The scope of applicable documents required for the exemption of GMO labeling will include a test report issued by a testing agency recognized by Ministry of Food and Drug Safety.
The Ministry of Agriculture, Food and Rural Affair (MAFRA) has been releasing the draft revision of Enforcement Decree and Enforcement Rule of Plant Protection Act to stakeholders and clients on the MAFRA's website for public consideration. The Main revisions of Enforcement Decree and Enforcement Rule of Plant Protection Act are attached.More information (in Korean) on the revision of Enforcement Decree and Rule of Plant Protection Act can be found on the MAFRA's website at: http://www.mafra.go.kr/
Republic of Korea is proposing to enact "Import Health requirements for Gelatin and Collagen".
The Republic of Korea is proposing to amend the "Special Act on Imported Food Safety Control": 1) A provision is newly created to permit the detention of import shipments without physical examination if there is evidence that the shipment may pose a risk to the public health; 2) The timing of import sanitary assessment conducted by the MFDS is adjusted to take place once the Ministry of Agriculture, Food and Rural Affairs commences the import risk analysis.
The Plant Protection Act of the Republic of Korea has been partially amended. The revision of Plant Protection Act will come into force on 3 December 2017.The main revision of the Plant Protection Act is attached.The original Acts (Korean) can be viewed on the National law information center (http://www.law.go.kr/lsEfInfoP.do?lsiSeq=188063 attachment: Main Revision of Plant Protection Act.
The Republic of Korea is proposing to amend the "Standards and Specifications for the Food Additives". 1) The standards for the use of the following 22 food additives are revised (including minor revision of wording): Fast green FCF and its aluminium lake, amaranth and its aluminium lake, erythrosine, allura red and its aluminium lake, ponceau 4R, brilliant blue FCF and its aluminium lake, indigocarmine and its aluminium lake, tartrazine and its aluminium lake, sunset yellow FCF and its aluminium lake, sodium metabisulfite, potassium metabisulfite, sulfur dioxide, sodium bisulfite, sodium sulfite, sodium hydrosulfite; 2) The synonyms of flavouring substance "isopropyl sorbate" are revised.
1. Develop specification for on site inspection of imported livestock 2. Revision of the harmful residue list for ineligible livestock products to suspend the importation and conduct additional laboratory tests
The proposed amendment seeks to: Revise the definition and standard for carbon isotope ratio of "Honey produced by sugar-fed honey bees." Establish and revise the "General Test Methods." Expand and revise the list of "Raw materials approved for use in foods." - Addition of flower, leaf and stem of "Rose of sharon (Hibiscus syriacus L.)", stem of Common ginger (Zingiber officinale Roscoe), Porous-head eelpout (Bothrocara hollandi), etc. - Revise the names of plant-origin raw materials according to the Korean Plant Names Index of the Korea Forest Service (KFS). Establish the maximum residue limit for a newly registered pesticide (Fenoxasulfone) in foods, and expand the range of target agricultural products for 32 pesticides. Harmonize the use standards of food additives with the "Standards and Specifications for Food Additives." Revise the supplementary provision of Ministry of Food and Drug Safety Notice No. 2016-154 to allow the application of amended regulations before the enforcement date.
In the host list of Potato spindle tuber viroid (PSTVd), Dahlia (Dahlia pinnata) should be modified to Dahlia (Dahlia spp.).