미국 FDA 재활용 플라스틱 NOL 신청

법규 배경 및 감독 기관 미국에서 “식품 접촉용 재활용 플라스틱”에 대한 관리는 미국 식품의약국(FDA)에서 담당합니다. 일반 식품 접촉용 플라스틱과 마찬가지로, 재활용 플라스틱도 《연방 식품·의약품·화장품법》(21 CFR)의 관련 요건을 충족해야 합니다. 또한 FDA는 《식품 포장용 재활용 플라스틱 가이드라인》을 발행하였으며, 이는 법적 강제력은 없고 공식적인 가이드로서 “식품 접촉용 재활용 플라스틱”의 적용에 대한 구체적인 기준을 제공합니다.   FDA NOL이란? FDA NOL(No Objection Letter)은 미국 식품의약국(FDA)이 발행하는 공식 문서로, 특정 제품이나 성분의 안전성 및 적합성에 대해 FDA가 이의가 없음을 명시한 것입니다. 이는 기업이 제품을 시장에 출시하거나 판매하는 데 있어 신뢰도 높은 적합성 증명서로 활용됩니다. 기업이 FDA에 특정 제품이나 성분에 관한 자료를 제출하면, FDA는 엄격한 심사 절차를 시작합니다. 이 과정에서 해당 제품이나 성분이 관련 기준을 충족하며 소비자 건강에 위해를 끼치지 않는지를 종합적으로 평가하게 됩니다. 모든 요건을 만족한다고 판단되면, FDA는 NOL을 발급하여 제품의 안전성과 적합성을 인정합니다.   《NOL 예시》   누가 FDA NOL을 신청해야 하나요? 신청 주체NOL의 신청 주체는 “재활용 플라스틱 설비 공급업체”와 “재활용 플라스틱 생산업체”를 포함합니다….

Jul. 31st, 2025

일본 식품 접촉 물질 규제 서비스

식품접촉물질이란? 일본에서는 《식품위생법》을 통해 식품 기구, 용기 및 포장(Utensils, Containers and Packages, UCP)을 명확히 정의하고 있습니다. 식품 기구: 식품 또는 식품첨가물과 직접 접촉하는 기계, 도구 또는 용기류 식품 용기 및 포장: 식품 또는 식품첨가물을 담거나 포장하기 위해 사용되며 이들과 직접 접촉하는 제품 즉, 일본에서의 식품 기구, 용기 및 포장은 모두 식품접촉물질(Food Contact Materials, FCM)의 범주에 속하며, 생산부터 사용까지 전 과정에서의 안전성을 보장하기 위한 규제 대상입니다.   일본의 식품접촉물질 규제기관 일본에서는 두 개의 핵심 기관이 식품접촉물질의 관리를 협력하여 담당합니다 일본 소비자청(Consumer Affairs Agency)2024년 4월 1일부터 식품접촉물질에 대한 관리 책임을 공식적으로 담당，관련 법령 및 기준을 제정하고 위험관리 업무를 수행   내각부 산하 식품안전위원회(Food Safety Commission of Japan)과학적 연구를 통해 위해성 평가를 수행하며, 의견 교류회 개최, 웹사이트 정보 업데이트 등을 통해 위해성 정보 소통과 교류를 실현 ※ 이외에도 JCII, 종이 및 인쇄잉크 협회 등 여러 산업 단체가 존재하며, 이들이 제정한 산업표준과 물질 리스트는 일본 사회에서 높은 인지도를 가지며 산업 관리와 안전 감독에 기여합니다….

May. 09th, 2025

US FDA Adds 10 Substances to Inventory of Effective FCS Notifications

The U.S. Food and Drug Administration (FDA) recently added ten new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below. 10 Food Contact Substances Newly Added to the Inventory FCN No. Food Contact Substance Manufacturer/Supplier Effective Date 2224 An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9). AFCO Jun 28, 2022 2214 Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3). REPLACES FCN 2047 DuPont Nutrition & Biosciences ApS Jun 24, 2022 2213 Oleic acid, mono ester with oxybis(propanediol) (CAS Reg. No. 49553-76-6). REPLACES FCN 2037 DuPont Nutrition & Biosciences ApS Jun 24, 2022 2223 A reactive mixture of ethylene acrylic acid copolymer (EAA; CAS Reg. No. 9010-77-9) and N,N,N\’,N\’-tetrakis(2-hydroxypropyl)adipamide (HAA; CAS Reg….

Aug. 01st, 2022

2019 Compliance Review: Global Food Contact Materials Management Requirements

An important role in the food chain, food contact materials are used in various links in food production, such as packaging, storage, and transportation. Food containers and packaging materials in food contact materials have a dual meaning in terms of food safety: on the one hand, they stand for suitable packaging methods and packaging materials which can protect food from environmental pollution and keep the food’s moisture and quality characteristics unchanged; on the other hand, the chemical components contained in the packaging may migrate into food. If the amount of migration exceeds a certain value, it can affect food safety. Countries around the world attach great importance to the quality and safety of food contact materials through the development and regular improvement of regulations, relevant quality and safety standards, testing technologies to ensure the quality and safety of food contact materials. Compliance Review “Company X” fined over a million yuan…

Mar. 01st, 2020

CFSA Seeks Public Comments on New Food Additives and Food Contact Materials

Takehome: The CFSA proposed the approval of 9 new varieties of food additives and 5 additives and resins used in food contact materials. On Oct 16, 2019, China National Center for Food Safety Risk Assessment (CFSA) published consultation drafts about 5 new varieties of food related products and 9 new varieties of food additives.Any feedback shall be submitted prior to Nov 12. The following table lists these 14 substances and their application guidance. Read More

Oct. 28th, 2019

China CFSA Consults on 4 New Additives and 6 Resins for Food Contact Materials

Takehome: The majority of additives and resins included in these amendments are applied in food-contact paints and coating. On Mar. 21, 2019, China CFSA opened public feedback on 10 new food related products, including 3 additives, 6 new resins and 1 additive with enlarged scope. The deadline for comments is Apr. 21, 2019. Read More

Apr. 01st, 2019

Analysis on Q1 2018 Announcement of New Food Contact Materials in China

According to Article 37 of Food Safety Law of the People’s Republic of China, the application of new raw materials for food production, or the production of new food additives and new food-related products is subject to safety assessment by health administrative department of the State Council. In other words, if a substance is not listed in the positive list (such as the GB 9685-2016 positive list for additives used in food contact materials and articles) or in the relevant announcements, it is required to be reported for record filing. This article analyzes and summarizes the announcement on new food contact materials in the first quarter of 2018. Read More

Sep. 03rd, 2018

Overview of RASFF Food Contact Material Notification in May 2018

There are 4 RASFF notifications on food contact materials in May 2018，in which there are 2 food contact material products from China (including Hong Kong), accounted for 50%. The main hazards for the notifications are migration of heavy metal, overall migration and primary aromatic amines from products. More information is shown below: Date Notification type Notified by Product Subject Action taken Risk decision countries concerned* 17/05/2018 border rejection Italy nylon serving spoons migration of primary aromatic amines (aniline: 4; 4,4′-MDA: 236 µg/kg – ppb) from nylon serving spoons from China destruction serious China (O) Italy 17/05/2018 alert Cyprus plastic disposable plates too high level of overall migration (26.20 mg/dm²) from plastic disposable plates for dessert from Italy recall from consumers serious Cyprus (D) Italy (O) 18/05/2018 border rejection Italy steel barbecue accessories migration of chromium (26.7 mg/dm²) from steel barbecue accessories from China placed under customs seals undecided China (O)…

Jun. 04th, 2018

CFSA Seeks Public Comments on 8 New Food Related Products

Takehome:  The CFSA introduced 8 new varieties of food contact materials additives and resins that are open to public comments until May 11, 2018. On April 13, 2018, China National Center for Food Safety Risk Assessment (CFSA) proposed the addition of 8 new varieties of food related products including one new additive and three new resins. Four food contact material additives have been proposed to have their application scopes expanded. The deadline for submission of public comment is May 11, 2018. The following table lists the 8 new food related products and their application guidance…… Read More

May. 04th, 2018

China Issues List of Non-compliant Imported Food Contact Materials and Products for First Quarter 2018

In the first quarter of 2018, China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) published a list of 69 imported non-compliant industrial products, among which 7 were non-compliant food contact materials and products. The main issues identified in these 7 products were excessive bacterial colonies, unqualified product identification, and excessive volatile substances. All products listed below have been found non-compliant: Table 1 Non-compliant imported food contact materials and products (First Quarter 2018) Number Product Origin Subject Action taken Port of entry 1 Roll paper China excessive bacterial colonies destruction Zhuhai 2 Roll paper China excessive bacterial colonies destruction Zhuhai 3 Roll paper China unqualified product identification destruction Zhuhai 4 Roll paper China unqualified product identification destruction Zhuhai 5 Silicon Feeding Bottle Korea excessive volatile substances returned Jiangsu 6 Silicone Nipple Korea excessive volatile substances returned Jiangsu 7 Silicon Feeding Bottle Korea excessive volatile substances returned Jiangsu Explanation: The…

May. 04th, 2018
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