미국 FDA MoCRA 제품 리스팅 가이드: 등록 절차, 면제 조건, FAQ 총정리!

 MoCRA 법규 배경 2022년 12월 29일, 《2023년 통합 세출법》(H. R.2617)의 일부, 『화장품 규제 현대화법(MoCRA : Modernization of Cosmetics Regulation Act of 2022)』이 공식적으로 발표되었습니다. 이 법안은 1938년 “식품, 의약품 및 화장품법”(Federal Food, Drug, and Cosmetic Act, 즉 FD&C법)이 공포된 이후 미국 화장품 규정의 첫 주요 업데이트입니다. 그 중 시설 등록(공장 등록)과 제품 리스팅은 MoCRA에 추가된 두 가지 필수 요구 사항입니다. 2023년 8월 7일, 미국 식품의약국(FDA)은 《화장품 시설 등록 및 제품 목록 지침》 초안을 발표하며 이 두 가지 요구 사항에 대해 자세히 설명했습니다.   제품 리스팅 대상 미국 시장에 화장품을 유통하는 모든 기업(해외 기업 포함)은 MoCRA에 따라 제품 리스팅을 진행해야 합니다. 단, 다음 두 가지 경우 제품 리스팅 등록이 면제됩니다. 1. 소규모 기업 최근 3년간 미국 시장에서의 화장품 연간 매출액이 100만 달러 미만인 기업 단, 다음 제품을 생산/가공하는 경우 면제 불가 – 소비자가 일반적으로 사용 시 눈 점막과 자주 접촉하는 화장품 (예: 아이섀도우, 아이 라이너, 속눈썹 접착제) – 주사용·내복용 화장품 – 외관…

Mar. 10th, 2025

우크라이나 화학물질 안전에 관한 기술 규정 서비스 (Ukraine REACH)

Ukraine REACH 개요 우크라이나 REACH(Technical Regulation on the Safety of Chemical Products)는 EU REACH를 모델로 한 화학물질 관리 법규 2024년 7월 23일 우크라이나 내각 승인 후 2025년 1월 26일 발효되었으며, 주관기관은 우크라이나 환경 보호 및 천연자원부(MEPR)     법령이행 대상 우크라이나 내 생산 및 제조자 우크라이나 내 수입자 해외 제조업체가 선임한 승인 대리인(Authorized Representative)     등록 면제 방사성 물질 폐기물 의약품 식품 비료 연구 개발 목적의 물질 등     등록 유형 및 절차 연간 1톤 이상 제조/수입하는 화학물질 등록 필요 2026년 1월 26일까지:  기존 화학물질(≥1톤/년) 사전 등록 2026년 10월 1일까지: 연간 ≥1,000톤, CMR 1A/1B ≥1톤, 수생환경 유해성 물질(Category 1) ≥100톤 2026년 6월 1일까지: 연간 100 ~ 1,000톤 03.01까지: 연간 1~100톤 연간 10톤 이상인 경우, 추가 자료 및 위해성 평가 보고서(CSR) 제출 필수       서비스 절차     리이치24시코리아 장점 REACH24H 해외 법인을 통한 직접 등록 및 대리인 서비스 영어, 일어, 중국어 등 다양한 언어에 능통한 고객…

Feb. 27th, 2025

인도 해외 제조업체 인증 제도 서비스 (BIS FMCS)

BIS FMCS 개요 해외 제조업체 인증 제도(Foreign Manufacturer Certification Scheme, FMCS)는 BIS 법(2016)과 BIS(적합성 평가) 규정(2018)을 준수하여 인도 표준국(Bureau of Indian Standards, BIS)이 규제하며, 해외 제조업체가 품질 관리 명령(Quality Control Orders, QCOs)을 통하여 표준 마크와 BIS 라이선스 취득 후 수입 가능 QCOs는 제품군별로 인도 정부의 중앙 부처의 감독하에 다양한 규제 기관 및 부처에서 규제 QCOs는 인도 관보(Gazette of India)에 공표되며, 시행일 명시 QCO의 시행일이 도래하기 전, BIS에서 유효한 라이선스 또는 적합성 인증서(CoC)를 취득하지 않은 경우, 해당 제품을 제조, 수입, 유통, 판매, 대여, 임대, 보관 또는 전시하는 것을 금지     법령이행 대상 인도 내 생산 혹은 제조자 인도 내 수입자 해외 기업이 선임한 인도 내 대리인 (AR, Authorized Representative)     등록 유형 및 절차 Scheme I : 화학물질, 가정용 전기제품, 철강제품, 시멘트, 조명, 가전제품, 배터리 등 Scheme II : 전자제품 및 IT 제품     서비스 절차     리이치24시코리아 장점 힌디어(현지인), 영어, 중국어, 일어 등 다양한 언어에 능통한…

Feb. 26th, 2025

REACH24H Drives Excellence in 2024 | Annual Report Released

HANGZHOU, 20 JANUARY 2025 – In 2024, REACH24H proudly continued its mission as a trusted partner, supporting clients worldwide across diverse sectors including industrial chemicals, pesticides, fertilizers, disinfectants, biocides, cosmetics, food, food contact materials, recycled plastics, and pharmaceuticals. Through innovation and collaboration, we achieved significant milestones, demonstrating our unwavering commitment to excellence and customer success. We have compiled the REACH24H 2024 Annual Report to share the key moments and advancements we\’ve experienced with you throughout the year. Click to Download the 2024 Annual Report The report also offers 2025 Regulatory Insights into regulatory trends across sectors. It highlights crucial regulatory updates and compliance alerts for 2025, aiding businesses in staying informed about regulatory changes and adjusting their global strategies to maintain competitiveness in a dynamic market environment. Enhancing Technical and Service Capabilities In 2024, REACH24H strengthened its position as a leading one-stop market access service provider, delivering comprehensive product compliance…

Jan. 20th, 2025

REACH24H Relocates Headquarters to Foster Innovation and Growth

HANGZHOU, 17 JANUARY 2025 – REACH24H Consulting Group is embarking on an exciting new chapter on 18 January 2025 with the relocation of its headquarters to the Headquarters Economy Park for Alumni Enterprises, Zhejiang University in Hangzhou, China. This state-of-the-art hub, co-established by the Hangzhou municipal government and Zhejiang University—one of China’s leading academic institutions—represents a commitment to fostering collaboration, innovation, and excellence. “As we step into this new chapter, we are ready to provide even better service and embrace a future filled with possibilities,” said Mr. Hong Fangwei, General Manager of REACH24H. Advancing Excellence and Innovation The move is more than a change of address; it marks a strategic step forward for REACH24H. With access to cutting-edge resources and a collaborative environment, the new headquarters will strengthen the company’s ability to deliver innovative solutions in global market access, product registration and compliance, and sustainable development. This transition underscores REACH24H’s…

Jan. 17th, 2025

REACH24H Secures MOA Feed Import Certificates for Brazilian Enterprises in China

HANGZHOU, DECEMBER 27, 2024 – REACH24H Consulting Group is proud to announce the successful acquisition of Import Registration Certificates for two feed raw material products in China on behalf of Brazilian enterprises. These certificates, granted by the Ministry of Agriculture and Rural Affairs of China, mark a critical milestone for the enterprises’ market entry into China. This achievement underscores our unwavering commitment to providing professional regulatory support for global businesses navigating China\’s complex regulatory landscape. Essential Steps for Feed Product Compliance in China Under China’s Administrative Measures for the Registration of Imported Feed and Feed Additives, foreign enterprises exporting feed and feed additives to China for the first time must entrust a resident representative institution in China or a domestic agency to apply to the Ministry of Agriculture and Rural Affairs for import registration to obtain the import registration certificate for feed and feed additives. Those without the import registration…

Dec. 27th, 2024

REACH24H Secures U.S. EPA Registration in All 51 States for Global Companies

HANGZHOU, 25 DECEMBER 2024 – As of December 2024, REACH24H has successfully secured over 200 U.S. EPA state registrations for global enterprises, covering a wide range of products, including end-use pesticides, manufacturing-use products, devices, and low-risk pesticides. This achievement marks REACH24H’s full coverage of EPA registrations in all 51 U.S. states, underscoring its leadership in regulatory compliance. A Record of Success: Full U.S. State Registration and U.S. EPA Expertise REACH24H’s work spans securing registrations under U.S. EPA requirements for conventional pesticides, antimicrobial agents, and biopesticides. The company is also recognized on the official list of U.S. EPA-approved service providers. With over a decade of experience, REACH24H excels in navigating the regulatory landscape and ensuring smooth market entry for its clients. REACH24H’s strong partnerships with U.S. state pesticide regulators ensure efficient and expedited processes for global companies entering the U.S. market. Understanding the U.S. Pesticide State Registration Process According to the…

Dec. 25th, 2024

REACH24H Strengthens Global Market Service Capability with New Business Development & Marketing Expert Joining REACH24H USA Inc.

WASHINGTON, D.C., DECEMBER 5, 2024 – REACH24H is pleased to announce the appointment of Caroline Santayana as Business Development & Marketing Manager for REACH24H USA Inc., effective November 2024. This strategic addition highlights our commitment to enhancing service capabilities in the U.S. market and delivering superior support and solutions to our global clients. Caroline brings a wealth of experience from her previous role as Director of Strategic Operations at the Independent Beauty Association (IBA). Her deep understanding of industry associations and commitment to client services provides invaluable insights into the evolving needs of businesses. Her expertise will be instrumental in guiding REACH24H\’s clients through complex regulatory landscapes across various sectors. \”Caroline\’s extensive experience in business development, sales, and marketing makes her an invaluable asset to our team,\” said Robert Kiefer, General Manager of REACH24H USA Inc. \”Her leadership will be crucial in advancing our mission to offer exceptional regulatory solutions…

Dec. 05th, 2024

REACH24H\’s Insights on Choosing a Compliance Service Provider: Safeguarding Trade Secrets

REACH24H Consulting Group, acknowledged by the Chinese government as a Trade Secret Protection Model Company, underscores its commitment to high service standards and the protection of business interests. In the global marketplace, companies must adhere to each country\’s market entry requirements and product safety regulations, which include product registration/notification and various compliance tasks. To effectively manage regulatory affairs, businesses often engage third-party compliance providers, necessitating the sharing of sensitive business information and trade secrets. For example, introducing a new cosmetic ingredient in China requires adherence to specific regulations and submission of various documents such as the New Cosmetic Ingredient R&D report, research documents on preparation techniques, stability, quality control standards, safety assessment documents, technical requirements, and other supportive documents. Similarly, products like chemicals, pesticides, fertilizers, and pharmaceuticals demand detailed information for registration or notification processes. This could include ingredient compositions, research methodologies, safety data, testing reports, and even supply chain…

Nov. 19th, 2024

REACH24H\’s Insights on Choosing a Compliance Service Provider: Safeguarding Trade Secrets

When exporting products globally, companies must comply with the market entry requirements of each country, including product registration and compliance tasks. To effectively manage regulatory affairs, businesses often engage third-party compliance providers, necessitating the sharing of sensitive business information and trade secrets. For example, introducing a new cosmetic ingredient in China requires adherence to specific regulations and submission of various documents such as the New Cosmetic Ingredient R&D report, research documents on preparation techniques, stability, quality control standards, safety assessment documents, technical requirements, and other supportive materials. Similarly, for products such as chemicals, pesticides, fertilizers, and pharmaceuticals, the registration/notification process demands detailed information as well. This could include ingredient compositions, research methodologies, safety data, testing reports, and even supply chain information and trade details like import/export volumes. Value of Protecting Trade Secrets Trade secrets are essential to an enterprise\’s competitiveness and are directly tied to its market position and growth…

Nov. 19th, 2024
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