Comment 0Times Lookup 526psc Date Created 23-05-22 14:10
Updated requirements for cosmetics according to MoCRA
Background of Modernization of Cosmetics Regulation Act of 2022
- On December 29th, 2022, US President Biden signed the Consolidated Appropriations Act, 2023, which includes MoCRA(Modernization of Cosmetics Regulation Act of 2022) under Subtitle E—Cosmetics.
- MoCRA added new requirements to Chapter VI of the FD&C Act(Federal Food, Drug, and Cosmetic Act), which will completely renew US cosmetics regulation.
- MoCRA is the most significant of the FDA's authority to regulate cosmetics since the passage of the FD&C Act in 1938, and helps to ensure the safety of the cosmetic products which consumers use every day.
MoCRA requires to comply with the followings :
- • Serious Adverse Event Reporting
- • Facility Registration, Cosmetic Product Listing
- • Safety Substantiation
- • Additional Labeling requirements
- • Record Keeping
- • GMP (Good Manufacturing Practice)
- MoCRA also requires the FDA to authorize mandatory recall and establish regulations for GMP, fragrance allergen labeling, and testing methods for cosmetics containing talc.
Discontinuation of VCRP
- VCRP(Voluntary Cosmetic Registration Program) was a program introduced in 1972 to voluntarily obtain information on manufacturing and distribution facilities, cosmetics and its ingredients, frequency of use, etc. from manufacturer, packer, and distributor of cosmetic products. However, since this was a voluntary registration rather, it did not present a complete picture of cosmetics in the US marketplace, so the FDA is creating a new system according to MoCRA.
- FDA has stopped accepting VCRP submissions for cosmetic facilities and products, effective from March 27, 2023, to develop a new system for facility and cosmetic product registration as mandated by MoCRA. Currently, the FDA is developing a system for facility and product registration in accordance with MoCRA requirements and will be provide further updates on its forthcoming availability.
- Please note that the existing VCRP registration will not be transferred to the newly developing program mandated by MoCRA.
Key Points of 『MoCRA』
1. Responsible Person
< Responsible Person >
According to SEC. 604 (4), the term ‘responsible person’ means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of this Act or section 4(a) of the Fair Packaging and Labeling Act.
2. Adverse Events
< Adverse Events >
(a) Serious Adverse Event reporting
- • The responsible person shall submit to the Secretary a serious adverse event report accompanied by a copy of the label on or within the retail packaging of such cosmetic product no later than 15 business days after the report is received by the responsible person. And the responsible person shall submit to the Secretary any new and material medical information, related to a serious adverse event report submitted to the Secretary in accordance with paragraph (1), that is received by the responsible person within 1 year of the initial report to the Secretary, no later than 15 business days after such information is received by such responsible person.
- • The term ‘serious adverse event’ means results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection; or significant disfigurement (including serious and persistent rashes, second or third- degree burns, significant alteration of appearance), other than as intended, under conditions of use that are customary or usual or when it requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph(A).
(b) Maintenance of Adverse Event Records
- • The responsible person shall maintain records related to each report of an adverse event associated with the use, in the United States, of a cosmetic product manufactured or distributed by such person received by such person, for a period of 6 years, except that a responsible person that is considered a small business for the purposes of section 612, who does not engage in the manufacturing or processing of the cosmetic products described in subsection 612(b), shall maintain such records for a period of 3 years.
• Small Business: Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in the subsection (b), shall be considered small businesses and not subject to the requirements of section 606 or 607.
(However, the exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products; (1) Cosmetics products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual. (2) Cosmetics products that are injected. (3) Cosmetics products that are intended for internal use. (4) Cosmetics products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.)
3. Facility Registration and Product Listing
< Facility Registration and Product Listing >
(a) Facility Registration
• The term ‘facility’ includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
- - EXISTING FACILITIES: Every person that, on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States shall register each facility with the Secretary not later than 1 year after date of enactment of such Act.
- - NEW FACILITIES: Every person that owns or operates a facility that first engages, after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, shall register with the Secretary such facility within 60 days of first engaging in such activity or 60 days after the deadline for registration under subparagraph (A), whichever is later.
- • A person required to register a facility under paragraph (1) shall renew such registrations with the Secretary biennially.
- • According to 604(3)(B), the term ‘facility’ does not include an establishment that solely performs labeling, relabeling, repacking, holding or distributing and an establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale.
• The registration shall contain :
- - the facility’s name, physical address, email address, and telephone number;
- - with respect to any foreign facility, the contact for the United States agent of the facility, and, if available, the electronic contact information;
- - the facility registration number, if any, previously assigned by the Secretary under subsection (d);
- - all brand names under which cosmetic products manufactured or processed in the facility are sold; and
- - the product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
- • A person that is required to register shall notify the Secretary within 60 days of any changes to information.
- • Contract Manufacturer: If a facility manufactures or processes cosmetic products on behalf of a responsible person, the Secretary shall require only a single registration for such facility even if such facility is manufacturing or processing its own cosmetic products or cosmetic products on behalf of
- • more than one responsible person. Such single registration may be submitted to the Secretary by such facility or any responsible person whose products are manufactured or processed at such facility.
- • The term ‘facility’ includes any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.
(b) Cosmetic Product Listing
• The responsible person shall submit to the Secretary a cosmetic product listing for each cosmetic product.
- - The responsible person of a cosmetic product that is marketed on the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 shall submit to the Secretary a cosmetic product listing not later than 1 year after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022.
- - For a cosmetic product, that is first marketed after the date of enactment of such Act, within 120 days of marketing such product in interstate commerce.
• Each such cosmetic product listing shall include :
- - the facility registration number of each facility where the cosmetic product is manufactured or processed;
- - the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
- - the applicable cosmetic category or categories for the cosmetic product;
- - a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient; and
- - the product listing number, if any previously assigned by the Secretary under subsection (d).
- • A responsible person that is required to submit a cosmetic product listing shall submit any updates to such cosmetic product listing annually.
- • The responsible person shall submit to the Secretary a cosmetic product listing for each cosmetic product.
4. Safety Substantiation
< Safety Substantiation >
- • Responsible person records shall identify and maintain records(tests, studies, research, analysis, other evidence or information) to support that there is adequate evidence of the cosmetic product's safety. (Section 608)
- • MoCRA does not adopt specific requirements for animal testing, but instead has provided Congress recognition that animal testing should not be used for the purpose of testing the safety of cosmetic products and should be phased out except with appropriate permits. (Section 3507)
< Labeling >
- • Until two years after the date of enactment of the law (until December 29th, 2024), cosmetic label shall include contact information(address, phone number or electronic contact number(email) in the United States, and (if applicable) web site) to receive reports of serious adverse health consequence.
- • Professional cosmetics labels shall include same information required for cosmetics sold to consumers. The label shall also state “only licensed professionals may use the product” by December 29th, 2024 (The term ‘professional’ means an individual licensed by a national authority to practice in the fields of skin care, nail care, barbering and aesthetics).
- • Within 18 months from the date of enactment (until June 29th, 2024), if the FDA establishes the fragrance allergen requirement, the product label shall indicate the fragrance allergen ingredient.
6. Record Access
< Record Access >
- • FDA has the authority to access to records related to cosmetic products if the FDA reasonably believes that the product or its ingredients are adulterated and has serious adverse health consequence.
- • This authority does not apply to cosmetic formulations/recipes or financial, pricing, sales, personnel or research data(other than safety substantiation data).
7. Other points
Current Good Manufacturing Practices Rule
- • The Secretary shall by regulation establish good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards.
- • The Secretary shall publish a notice of proposed rulemaking not later than 2 years after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022 and shall publish a final such rule not later than 3 years after such date of enactment.
- • adulterated products: If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 606.
- • Not later than one year after the date of enactment of this Act, shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
- • Not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.
PFAS in Cosmetics
- • The Secretary shall assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use.
- • Not later than 3 years after enactment of this Act, the Secretary shall publish on the website of the Food and Drug Administration a report summarizing the results of the assessment.
Mandatory Recall authority
- • If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 601 or misbranded under section 602 and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article.
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