새로운 FDA 법률 이해 및 완전한 규정 준수 달성하기

MoCRA(미국 화장품 규정 현대화법) 는 2022년 12월에 발효되었으며, 1938년 이후 미국 화장품 규정의 가장 큰 개편입니다.
이 법은 미국 내 화장품 제조업체, 유통업체, 수입업체 모두에게 의무 요건을 도입하고 있습니다.

미국 브랜드든, 해외 제조사든, Amazon 판매자든 관계없이
미국 MoCRA 화장품 규정 준수는 이제 법적 의무입니다.
이 가이드는 새로운 FDA 화장품 규정을 준수하는 데 필요한 모든 정보를 제공합니다.

Cosmereg는 미국 시장 진출을 준비하는 화장품 브랜드, 제조사, 프라이빗 라벨러를 위해
제품 출시, 라벨 검토, 또는 MoCRA 규정을 준수하는 미국 에이전트 지정 등
법적 요건을 단계별로 안내하고 완전한 규정 준수를 도와드립니다.

MoCRA란 무엇인가요?

MoCRA(Makeup Modernization of Cosmetics Regulation Act) 는
2023년 통합 세출법(Consolidated Appropriations Act)의 일부로,
미국 FDA의 화장품 규제 권한을 대폭 강화하는 내용을 포함하고 있습니다.

주요 목표:

MoCRA 화장품 규정을 따라야 하는 대상은 누구인가요?

미국 MoCRA 화장품 규정은 미국에서 판매되는 모든 화장품에 적용되며, 다음과 같은 기업들이 해당됩니다:

미국 외 지역에 본사를 둔 경우,
FDA와의 공식 커뮤니케이션을 담당할 미국 에이전트를 반드시 지정해야 하는 법적 의무가 생깁니다.
Cosmereg는 이 역할을 전문적으로 수행하며, 규정 준수를 지원합니다.

MoCRA 화장품 규정 준수 체크리스트

귀사의 화장품이 미국 MoCRA 화장품 규정에 부합하려면 다음 항목을 반드시 이행해야 합니다:

제조 시설 등록 (Facility Registration)

미국 및 해외 제조업체 모두에게 의무사항
시설의 이름, 주소, 연락처 정보를 포함해야 함
해외 제조 시설은 반드시 미국 에이전트 지정 필수
2년마다 재등록 필요
최초 등록 마감일: 2023년 12월 31일

제품 등록 (Cosmetic Product Listing)

제품 안전성 입증 (Safety Substantiation)

중대한 이상사례 보고 (Serious Adverse Event Reporting)

라벨링 요건 변경 (Labeling Changes)

우수 제조관리 기준 (GMP – Good Manufacturing Practices)

MoCRA에서 미국 에이전트는 어떤 역할을 하나요?

해외 제조 시설은 반드시 미국 에이전트를 지정해야 하며, 이들은 다음과 같은 업무를 수행합니다:

MoCRA 화장품 규정 준수 체크리스트

Cosmereg의 지원 내용

FDA 대상 제조 시설 및 제품 등록 지원
FDA 등록 미국 에이전트 서비스 제공
라벨링 규정 준수 검토
안전성 평가 자료(Dossier) 작성 지원
GMP(우수 제조관리 기준) 이행 가이드 제공

Cosmereg는 화장품 브랜드와 제조사가 미국 FDA 요건을 빠르고 효율적으로 충족할 수 있도록 지원합니다.

MoCRA 규정 준수, 지금 시작하세요

복잡한 미국 MoCRA 화장품 규정은 저희 전문가 팀이 처리합니다.귀하는 브랜드 성장에 집중하세요.

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

Prepare for the upcoming changes mandated by the
Modernization of Cosmetics Regulation Act of 2022 (MoCRA Cosmetics),
as it significantly transforms the regulatory landscape
for cosmetic companies in the United States.
The MoCRA cosmetics regulations, which comes into full effect in 2023,
represents a substantial expansion of the FDA’s authority
over the cosmetics industry.

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.

WHY CHOOSE US

We offer you peace of mind
by assuming responsibility for compliance activities,
allowing you to focus exclusively on the task
of marketing your cosmetics.
With a wealth of experience spanning over a decade
in the field of cosmetic compliance, our agency has
a team of seasoned Safety Assessors and dedication to
exceptional customer support and US Mocra Agent for Cosmetics.

Trust us to guide you through these
regulatory changes with the highest levels of
expertise and professionalism.

새로운 FDA 법률 이해 및 완전한 규정 준수 달성하기

MoCRA란 무엇인가요?

주요 목표:

MoCRA 화장품 규정을 따라야 하는 대상은 누구인가요?

MoCRA 화장품 규정 준수 체크리스트

제조 시설 등록 (Facility Registration)

제품 등록 (Cosmetic Product Listing)

제품 안전성 입증 (Safety Substantiation)

중대한 이상사례 보고 (Serious Adverse Event Reporting)

라벨링 요건 변경 (Labeling Changes)

우수 제조관리 기준 (GMP – Good Manufacturing Practices)

MoCRA에서 미국 에이전트는 어떤 역할을 하나요?

MoCRA 화장품 규정 준수 체크리스트

Cosmereg의 지원 내용

MoCRA 규정 준수, 지금 시작하세요

ARE YOU READY MOCRA COSMETICS REGULATIONS?

DISCOVER THE NEW RULES

Simplify your path to compliance with new FDA requirements under the Modernization of Cosmetics Regulation Act of 2022

INTRODUCING MoCRA COSMETICS

DON'T STRESS… …WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements may seem overwhelming, but we’re here to make it easy for you.

Our mission is to ensure you’re fully compliant without the headache.

THESE NEW REQUIREMENTS INCLUDE:

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Compulsory FDA Facility Registration All cosmetic facilities must undergo mandatory registration with the FDA.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Product Listing Obligations Every cosmetic product marketed in the USA must be listed as per regulatory requirements.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Compliance with FDA-issued GMPs Strict adherence to FDA-issued Good Manufacturing Practices is mandated.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Comprehensive Record-Keeping This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Mandatory Recall Procedures In the event of safety concerns, mandatory recalls may be required

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

Fragrance Allergen Declaration Companies may be required to declare fragrance allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA, MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

OUR SERVICES

SWIFT FDA FACILITY REGISTRATION We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT We handle the submission and management of cosmetic product listings, ensuring you meet all necessary obligations.

TIMELY UPDATES As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRAMEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide rangeof regulations that impact every facet of your cosmetic products, from their creation to their marketing.

BENEFIT FOR YOU

Our services are there to meet the needs of cosmetic manufacturers and brand owners planning to sell or export cosmetics in the United States. We understand the complexities of navigating the complex FDA regulations, especially in light of these new requirements.

WHY CHOOSE US

COSMEREG

빠른 링크

인기 있는

콘택트 렌즈

US FDA Regulations

Health Canada Regulations

EU/UK Regulations

콘택트 렌즈

Simplify your path to compliance with
new FDA requirements under the Modernization of
Cosmetics Regulation Act of 2022

DON'T STRESS…
…WE SIMPLIFY

Navigating the new MoCRA Cosmetics requirements
may seem overwhelming, but we’re here
to make it easy for you.

Our mission is to ensure
you’re fully compliant without the headache.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Compulsory FDA Facility Registration
All cosmetic facilities must undergo mandatory
registration with the FDA.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Product Listing Obligations
Every cosmetic product marketed in the USA must
be listed as per regulatory requirements.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Adverse Event Reporting
Companies will be obligated to report adverse events associated with their products.

Compliance with FDA-issued GMPs
Strict adherence to FDA-issued Good Manufacturing
Practices is mandated.

Compliance with
FDA-issued GMPs
Strict adherence to
FDA-issued Good Manufacturing
Practices is mandated.

Comprehensive Record-Keeping
This involves the maintenance of records, including
adverse events and safety substantiation records.

Comprehensive
Record-Keeping
This involves the maintenance of records, including adverse events and safety substantiation records.

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Mandatory Recall Procedures
In the event of safety concerns, mandatory
recalls may be required

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

Fragrance Allergen Declaration
Companies may be required to declare fragrance
allergens in their products.

WHILE SPECIFIC REGULATIONS ARE YET TO BE DEFINED BY THE FDA,
MoCRA OFFERS VALUABLE INSIGHT FOR COSMETIC COMPANIES
TO BEGIN PREPARATIONS FOR THE NEW FDA REQUIREMENTS.

SWIFT FDA FACILITY REGISTRATION
We’ll ensure your facilities are promptly registered with the FDA, meeting the MoCRA Cosmetics mandatory requirement.

MOCRA US AGENT SERVICES
If you’re a foreign cosmetic company, we’ll be your go-to US agent, handling communication and compliance on your behalf.

MOCRA COSMETICS LISTING MANAGEMENT
We handle the submission and
management of cosmetic product
listings, ensuring you meet all
necessary obligations.

TIMELY UPDATES
As the FDA implements additional MoCRA guidelines, we will keep you well-informed about the changes and requirements affecting your business.

WHAT DOES MoCRA
MEAN FOR COSMETIC COMPANIES?

MoCRA Cosmetics Regulations empowers the FDA to establish a wide range
of regulations that impact every facet of your cosmetic products, from their creation to their marketing.

Our services are there to meet the needs of
cosmetic manufacturers and brand owners
planning to sell or export cosmetics
in the United States.

We understand the complexities of navigating the
complex FDA regulations, especially in light of these
new requirements.