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輸出する国・地域別⑥ 『北米(アメリカ、カナダ)』 


米国FDAウェブサイト内に、MoCRA(Modernization of Cosmetics Regulation Act of 2022)の概要を解説するWebinarが公開されています。








(Modernization of Cosmetics Regulation Act of 2022
Key Terms and Provisions)

Hello and welcome to the United States Food and Drug Administration Stakeholder Webinar to provide an overview of the modernization of Cosmetic Regulations Act of 2022.

Following this introduction, you will hear from our chief scientist, Dr.Nemanja Bumpus, who will provide brief opening remark. After which I will go over the requirements mandated by the act, also known as MoCRA, and the current steps the FDA is taking to implement the act. Finally, Dr. Bumpus and I will answer frequently asked questions about MoCRA, then close out the program. I will now turn over to Dr. Bumpus.

Thank you, Dr. Katz. Most Americans use cosmetic products every day. These products include makeup, face and body cleanser, shaving cream, deodorant, perfume, and a number of other products. In December, 2022, Congress passed the Modernization of Cosmetics Regulation Act or MoCRA.

It is the most significant expansion of FDA’s authority to regulate cosmetics. Since the Federal Food Drug and Cosmetic Act was passed in 1938, this new law will help ensure the safety of cosmetic products Americans use daily. In a moment, you’ll hear about the various provisions of MoCRA, like the mandatory reporting of serious adverse events and mandatory facility registration and cosmetic product listing.

As part of FDA’s mission, the agency is responsible for protecting the public health by helping to ensure the safety as of cosmetics. We look forward to implementing this new statutory authority to help keep American’s cosmetics safe.

Thank you Dr. Bumpus for this energizing remarks. As Dr. Bumpus mentioned, MoCRA provides FDA with new authorities and establishes require new requirements for cosmetics companies.


続いて、チーフサイエンティストであるNemanja Bumpus博士から簡単な挨拶があります。その後、MoCRAとして知られるこの法律で義務付けられた要件と、この法律を実施するためにFDAがとっている現在の措置について説明します。最後に、バンプス博士と私がMoCRAに関するよくある質問にお答えし、このプログラムを終了します。それでは、Bumpus博士、お願いします。

カッツ博士、ありがとうございます。ほとんどのアメリカ人は毎日、化粧品を使用しています。これらの製品には、メイクアップ、洗顔料、ボディクレンザー、シェービングクリーム、デオドラント、香水、その他多くの製品があります。2022年12月、議会はModernization of Cosmetics Regulation Act、MoCRAを可決しました。






(Cosmetic Product)














What I’d like to do now are to go through some of the definitions relevant to the provisions of MoCRA, and I’ll start with cosmetic products. A cosmetic product is defined in MoCRA as a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.  Facility… any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States. そこで、MoCRAの規定に関連するいくつかの定義について説明したいと思いますが、まず化粧品について説明します。MoCRAでは、化粧品とは、最終製品に使用するために質的および量的に設定された組成を持つ化粧品原料の調合品と定義されています。 施設…米国内で流通する化粧品を製造または加工する施設(輸入業者の施設も含む)を指します。





2:44~ There are carve outs for certain beauty shops and assault and salons, certain retailers, hospitals, public health agencies, trade shows, certain research and testing facilities, and for establishments that solely perform one or more of the following, with respect to cosmetic products, that would include labeling, relabeling, packaging, repackaging, holding, and distributing. 特定の美容室、サロン、特定の小売業者、病院、公衆衛生機関、展示会、特定の研究・試験施設、および化粧品に関して、ラベル付け、再ラベル付け、包装、再包装、保管、配布を含む以下の1つまたは複数を単独で行う施設は、除外されています。

(Responsible person)



A responsible person, is defined as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of the cosmetic product. 責任者とは、化粧品のラベルに名前が記載されている化粧品の製造者、包装業者、販売業者と定義されます。

(Adverse Event)






An adverse event is described and defined as any health related event associated with the use of cosmetic product that is adverse. 有害事象とは、化粧品の使用に関連する健康関連の事象で、有害なものと説明・定義されています。

(Serious Adverse Event)

03:35~ A serious adverse event is an event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth.

An infection or significant disfigurement, including serious and persistent rashes. Second or third degree burns, significant hair loss or persistent or significant alterations of appearance other than as intended under conditions of use that are customary or usual, or it requires based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in the proceeding paragraph.




(MoCRA Provisions)


04:26~  I’d like to address certain provisions in MoCRA, starting with records inspection. MoCRA amends the FD&C Act to provide that FDA inspections of facilities that manufacture or process cosmetics shall extend certain records and information such as adverse event report information when the applicable standards for record inspection applies. MoCRAの条項のうち、まずは記録検査について取り上げたいと思います。MoCRAはFD&C法を改正し、化粧品を製造または加工する施設に対するFDAの検査は、記録検査の適用基準が適用される場合、有害事象報告情報などの特定の記録および情報を拡大することを規定しています。

(Record Inspection)



(Record Access)






Records access- If FDA has a reasonable belief that a cosmetic product, including an ingredient in such product is likely to be adulterated, such that the use or exposure to the product presents the threat of serious adverse human health consequences or death to humans, the FDA can access and copy certain records related to the cosmetic product, including safety records. 記録へのアクセス- FDAが、化粧品(そのような製品の成分を含む)が、その製品の使用または曝露により、ヒトに深刻な有害健康影響または死亡の脅威をもたらすような不純物の可能性があると合理的に考える場合、FDAは、安全記録を含む化粧品に関連する特定の記録を閲覧およびコピーできます。

(Safety substantiation)



Safety substantiation – A responsible person is required to ensure and maintain records supporting adequate substantiation of safety for their products. The next item is mandatory serious adverse event reporting. 安全性の立証 – 責任者は、自社製品の安全性の十分な立証を裏付ける記録を確保し、維持することが要求される。

(Mandatory Serious Adverse Events Reporting)

05:37~ Here a responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to the FDA within 15 business days.

After receiving a report of such event, the responsible person must also provide certain additional information, such as new medical information received within one year of the initial report. FDA will also have access to adverse event reports during an inspection.




(Registration and Product Listing)




It also further provides for registration and product listing.

Cosmetic manufacturers have processors must register their facilities with FDA and renew their registration every two years.

FDA has the authority to suspend a facility’s registration if the Agency disturb determines that a cosmetic product manufacture, or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or product, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.





(Registration and Product Listing) 続き

Further, it is a prohibited act to distribute or sell or otherwise introduce or deliver into commerce in the United States cosmetic products from a facility with a suspended registration. In addition, a responsible person must list each marketed cosmetic product with the FDA, including products, product, ingredients, and provide any updates annually. さらに、登録が停止された施設からの化粧品の頒布や販売、あるいは米国内の商業への導入や納入は禁止されている行為である。さらに、責任者は、販売される各化粧品を、製品、製品、成分を含めてFDAにリストアップし、毎年あらゆる最新情報を提供しなければなりません。
(Mandatory Recall Authority)
07:37~ It provides FDA with mandatory recall authority if FDA determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and use of, or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily. これは、化粧品が粗悪品または不当表示であり、その化粧品の使用または暴露により重大な健康被害または死亡を引き起こす合理的な可能性があるとFDAが判断した場合、責任者が自発的に拒否した場合、FDAに強制リコールを命ずる権限を与えるものです。

(Labeling-Professional Use)







In addition for labeling provisions, there is a professional use labeling provision that requires certain labeling for cosmetic products that are intended to be used only by licensed professionals. また、表示に関する規定として、認可を受けた専門家のみが使用することを目的とした化粧品に一定の表示を義務付ける専門家使用表示規定があります。

(Labeling-Contact Information)

The following provision is enforceable under MoCRA beginning December 29th, 2024, and this provides for contact information for the labeling and it requires a cosmetic product labels to include certain contact information through which the responsible person can receive adverse event reports.

Contact information must include domestic address, phone number or electronic contact information, which may include a website.




(Labeling of Fragrance Allergens Rule)

08:54~ The following requirements will also apply following FDA rulemaking; a label of fragrance, allergen rule, and FDA is to develop regulations to identify fragrance allergens they must also be disclosed on cosmetics label. Taking into consideration international, state and local allergen disclosure requirements. また、FDAの規則制定後、以下の要件が適用される。香りのラベル、アレルゲンの規則、FDAは香りのアレルゲンを特定するための規則を策定することになっており、それらは化粧品のラベルにも開示する必要がある。国際的、州および地域のアレルゲン開示要件を考慮すること。

(Good Manufacturing Practice (GMP) Rule


09:20~ Good manufacturing practice or GMP rule, the FDA is to establish GMPs consistent to the extent practical, both, and appropriate with national and international standards, and intended to ensure that cosmetic products are not adulterated.

This may also include inspections to evaluate compliance with GMPs.




(Testing Methods for Detecting Asbestos in Talc-containing Cosmetics Rule)

09:43~  Test methods for detecting asbestos and talc-containing cosmetic rule. FDA is to develop regulations to establish and require standardized testing methods for detecting and identifying asbestos and talc-containing cosmetic products. アスベストおよびタルク含有化粧品の検出のための試験方法に関する規則。FDAは、アスベストおよびタルク含有化粧品の検出および識別のための標準化された試験方法を確立し、要求するための規則を策定することとしています。

Report on PFAS in Cosmetics



In addition, FDA will be issuing a report on PFAS and cosmetics by December 29th, 2025. This report will summarize an assessment of the safety of the use of per- and polyfluoroalkyl substances or PFAS in cosmetic products. さらに、FDAは2025年12月29日までにPFASと化粧品に関する報告書を発行する予定である。この報告書は、化粧品におけるパーフルオロアルキル物質およびポリフルオロアルキル物質またはPFASの使用に関する安全性の評価をまとめたものです。

MoCRA Statutory Dates


10:22~ Finally, the MoCRA statutory dates are listed in the slides. The key provisions are on the left and the order in which they occur in MoCRA.

And on the right you can see the line for when those statutory dates occur. The lighter blue lines indicate places where FDA is required to do a proposed rule and a final rule.




10:46~ In addition, FDA is working to implement all of these new requirements. With respect to registration and listing, FDA is creating a new system to handle these submissions.

As of March 27th, 2023, we have stopped accepting submissions to the voluntary cosmetic registration program or the VCRP because MoCRA requires certain companies to register their facilities and list their products with FDA.  FDA is creating a new system to handle the large number of submissions that will result. FDA therefore will no longer be using the voluntary cosmetic  registration system, and is no longer accepting and processing submissions to the VCRP.

Information in the VCRP will also not be transferred to the new program being developed for facility registration and product listing mandated by MoCRA. FDA will announce the availability of the new system. In addition, the FDA will be also hosting a listening session on good manufacturing practices or GMPs on June 1st, 2023.


MoCRAは、特定の企業に対し、FDAへの施設登録と製品のリストアップを義務づけているため、2023年3月27日をもって、自主的な化粧品登録プログラム(VCRP)への提出の受付を停止しました。 FDAは、その結果生じる大量の提出物を処理するために、新しいシステムを構築しています。したがって、FDAは今後、自主的な化粧品登録システムを使用せず、VCRPへの提出を受け付け、処理することはありません。

また、VCRPの情報は、MoCRAによって義務付けられた施設登録と製品リストのために開発されている新しいプログラムには引き継がれません。FDAは、新システムの利用可能性を発表する予定です。さらに、FDAは2023年6月1日にGMP(Good Manufacturing Practice)に関するリスニングセッションを開催する予定です。

The purpose of the listening session is to hear from cosmetic manufacturers, including smaller businesses, consumers organizations, and other experts, so they can help to inform the agency’s efforts as we develop regulations to establish GMPs for facilities that manufacture or process cosmetic products distributed in the United States.

For more information on the registration and listing system and the GMP listening sessions, please visit our website shown here.

Dr. Bumpus. I will now turn it over to you for us to go through some of the frequently asked question.




Thank you, Dr. Katz. We’ll now answer some frequently asked questions that we’ve received so far about MoCRA.

To kick us off, we have the following question: many manufacturers are wondering about the new process for facility registration, product listing and adverse event reporting. “When will guidance to comply with the new requirements be made available to industry?” That’s a great question and one we know many manufacturers are concerned about.

The new law requires certain cosmetic facilities to comply with various new requirements, including mandatory facility registration and product listing by December 29th, 2023. In addition, it establishes mandatory reporting of serious adverse event and to report a serious adverse event, please submit a MedWatch Online Reporting Form.

FDA is also working to address the new provisions in MoCRA, and we’ll share new information when available. We recommend following our social media @FDACosmetics and @DrBumpusFDA on Twitter, also subscribing to our email updates and checking our cosmetic news and events webpage to stay up to date as we continue to make announcements on FDA’s efforts.

We also encourage you to attend our GMP listening session on June 1st, 2023 to share input as we develop GMP mandated by MoCRA.


まず始めに、以下の質問です。多くのメーカーが、施設登録、製品リスト、有害事象報告に関する新しいプロセスについて疑問を抱いています。”新しい要件に準拠するためのガイダンスは、いつ業界に提供されるのでしょうか?” これは素晴らしい質問であり、多くのメーカーが懸念していることを私たちは知っています。

新法では、特定の化粧品施設に対し、2023年12月29日までに施設登録や製品リストの義務化など、さまざまな新要件を遵守するよう求めています。さらに、重篤な有害事象の報告義務を定めており、重篤な有害事象を報告するには、MedWatch Online Reporting Formを提出してください。



Thanks, Dr. Katz. Our next question is, where can we find the forms and online registration needed to be compliant by the December, 2023 deadline? To reiterate, we are creating a new system to receive the mandatory registration and listing submissions.

FDA will therefore no longer be using the VCRP or voluntary registration program forms. We request that cosmetic companies wait to register with FDA until we announce the availability of the new system. Again, we encourage you to follow us on social media @FDACosmetics and @DrBumpusFDA on Twitter and to check our cosmetic news and events webpage, so that you can be informed of what we make new announcements and announcements related to this topic.

Thank you. And we have time for one final question, and that is, will you be introducing new cosmetics requirement in addition to MoCRA. FDA enforces laws enacted by Congress and issues regulations as authorized by Congress, MoCRA is the most recent law enacted to strengthen our regulation of cosmetics.

To implement this new authority, we will be conducting rulemaking and issuing guidance document. We’ll inform the cosmetics industry and other stakeholders throughout this process.

Thank you, Dr. Katz. And that wraps up today’s web webinar. If you have any questions about MoCRA, please visit our website or email questions and thank you for joining us and be well.