0599 Cosmetics including 0027 SSA 2020 REV

UNITED STATES FOOD & DRUG ADMINISTRATION
Cosmetic Labeling Regulations and
Voluntary Cosmetic Registration
OMB Control No. 0910-0599 - Revision
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, us or
we) regulations pertaining to cosmetic labeling and voluntary cosmetic registration. These
regulations are codified in FDA regulations at 21 CFR parts 701, 710, and 720. For
efficiency of agency operations we are revising the information collection to consolidate
related activities.
Cosmetic Labeling Regulations
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the Fair Packaging and
Labeling Act (the FPLA) require that cosmetic manufacturers, packers, and distributors
disclose information about themselves or their products on the labels or labeling of their
products. Sections 201, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C.
321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453
and 1454) provide authority to FDA to regulate the labeling of cosmetic products. Failure to
comply with the requirements for cosmetic labeling may render a cosmetic adulterated under
section 601 of the FD&C Act or misbranded under section 602 of the FD&C Act. Under the
FD&C Act and the FPLA, cosmetic labels must bear a statement of identity of the cosmetic
product, the name and place of business of the manufacturer, packer, or distributor, and an
accurate statement of the net quantity of contents. These requirements apply both to
cosmetics that are marketed as consumer commodities (offered for retail sale) and to
cosmetics that are manufactured and sold “for professional use only.”
Under the FPLA, cosmetic products that are offered for retail sale must bear a declaration of
the name of each ingredient in descending order of predominance, except that a fragrance or
flavor may be listed as “fragrance” or “flavor.” In addition, ingredients present at a
concentration of less than 1 percent and color additives may be grouped at the end of the
ingredient statement. The requirement for declaration of ingredients does not apply to nonretail professional-use-only products unless such declaration is specifically required by
applicable regulations.
Voluntary Cosmetic Registration Program
The FD&C Act provides FDA with the authority to regulate cosmetic products in the United
States. To assist us in carrying out our responsibility to regulate cosmetics, the agency
developed the Voluntary Cosmetic Registration Program (VCRP). FDA forms for the
VCRP (Forms FDA 2511, 2512, and 2512a) assist respondents submitting information by
provide a uniform reporting instrument. Participation in the VCRP is voluntary under

provisions found in parts 710 and 720 (21 CFR parts 710 and 720) of our regulations.
Participants have the option of submitting information via paper forms or via the online
interface. The term “form” refers to both the paper form and the online system.
Pursuant to part 710, we request that establishments that manufacture or package cosmetic
products register with the agency on Form FDA 2511, “Registration of Cosmetic Product
Establishment.” The online version of Form FDA 2511 is available on FDA’s VCRP
website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/onlineregistration-voluntary-cosmetic-registration-program-vcrp. We strongly encourage online
registration using Form FDA 2511 because it is faster and more efficient for the filer and the
agency. A registering facility receives confirmation of online registration, including a
registration number by email. The online registration system also allows for amendments to
past submissions.
Because registration of cosmetic product establishments is not mandatory, voluntary
registration provides us with the best information available about locations, business trade
names, and types of activity (manufacturing or packaging) of cosmetic product
establishments. We place registration information into a database and use the information to
generate mailing lists for distributing regulatory information and inviting firms to participate
in workshops on topics in which they may be interested. Registration is permanent,
although we request that respondents submit an amended Form FDA 2511 if any of the
originally submitted information changes.
Pursuant to part 720 (21 CFR part 720), we request firms that manufacture, pack, or
distribute cosmetics to file with the agency an ingredient statement for each of their
products. Filing of cosmetic product ingredient statements is also voluntary. Ingredient
statements for new submissions (§§ 720.1 through 720.4) are reported on Form FDA 2512,
“Cosmetic Product Ingredient Statement,” and on Form FDA 2512a, a continuation form.
Amendments to product formulations (§ 720.6) are also reported on Forms FDA 2512 and
FDA 2512a. When a firm discontinues the commercial distribution of a cosmetic, we
request that the firm notify us that they have discontinued their cosmetic product by
submitting an amended Form FDA 2512 (§§ 720.3 and 720.6). If any of the information
submitted on or with these forms is confidential, the firm may submit a request for
confidentiality of a cosmetic ingredient under § 720.8.
Our use of an electronic system has been designed to make it easier for participants to
provide cosmetic registration information to us about their products. The electronic
submission system also assists participants, through interactive question and response
scenarios, to identify submissions that will be ineligible to be accepted in VCRP because
they do not meet parts 710 and 720 requirements. The electronic system reduces burden
currently associated with the manual identification process for filers and FDA. The online
version of Forms FDA 2512 and FDA 2512a are available on our VCRP website at
https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registrationvoluntary-cosmetic-registration-program-vcrp. The forms also include links between Forms
FDA 2511 and 2512, clarification of what information should be entered into the forms,
additional self-identifying fields, and the removal of certain duplicative fields.

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Our paper-based process confirms that each submission meets the requirements established
in parts 710 and 720 through the use of a manual process for both filers and FDA reviewers
that may result in a long waiting period where filers must wait and then respond to questions
generated by FDA, which may result in a high rejection rate. We have experienced a
significant reduction in rejection rates when using the electronic forms.
We place cosmetic product filing information in a computer database and use the
information when we receive inquiries about cosmetics marketed in the United States.
Because filing of cosmetic product formulations is not mandatory, voluntary filings with
FDA provide us with the best information available about cosmetic products, ingredients,
frequency of use, businesses engaged in the manufacture and distribution of cosmetics, and
approximate rates of product discontinuance and formula modifications. The information
assists our scientists in evaluating reports of cosmetic adverse events submitted via the
MedWatch and Field Operators (FACTS) systems. We also use the information in
identifying future research projects, to evaluate the levels and safety of certain ingredients in
cosmetics.
Accordingly, we request OMB approval of the information collection provisions associated
with our cosmetic regulations in 21 CFR parts 701, 710, and 720, associated Forms FDA
2511, 2512, and 2512a, as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information required to be disclosed in FDA’s cosmetic labeling regulations is used by
consumers of cosmetic products when evaluating, purchasing, and using the products. We
use the information to evaluate cosmetic products currently on the market and to verify
compliance with the requirements for labeling cosmetic products.
Registration of cosmetic product establishments is not mandatory so voluntary registrations
provide FDA with the best information available about the locations, business trade names,
and types of activity (manufacturing or packaging) of cosmetic product establishments. We
place registration information into a computer database and use the information to generate
mailing lists for distributing regulatory information and for inviting firms to participate in
workshops on topics in which they may be interested. We also use the information for
estimating the size of the cosmetic industry, evaluating cosmetic products currently on the
market, and for conducting onsite establishment inspections. Registration is permanent,
although we request that respondents submit an amended Form FDA 2511 if any of the
originally submitted information changes.
Filing of cosmetic product formulations is not mandatory so voluntary filings provide FDA
with the best information available about cosmetic product ingredients and their frequency
of use, businesses engaged in the manufacture and distribution of cosmetics, and
approximate rates of product discontinuance and formula modifications. The information
assists FDA scientists in evaluating reports of alleged injuries and adverse reactions from the
use of cosmetics. The information also is used in defining and planning analytical and
toxicological studies pertaining to cosmetics.

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Description of Respondents: Respondents to this collection of information include
manufacturers, packers, and distributors of cosmetics sold in the United States. Respondents
are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
Labeling
Cosmetic product manufacturers, packers, and distributors may use any available
information technology to develop their product labels. However, there is currently no
information technology that establishments can use as a substitute for conventional product
labels to deliver the necessary information to consumers.
Registration
We request that establishments that manufacture or package cosmetic products register with
the agency on Form FDA 2511. The term “Form FDA 2511” refers to both the paper and
the online registration system versions of the form. Both versions are available on FDA’s
VCRP website and we strongly encourage electronic registration because it is faster and
more convenient. Registering facilities will receive confirmation of electronic registration
including a registration number by email, usually within 7 business days. The online system
also allows for amendments to past submissions.
Filing of Ingredient Statements
FDA’s online filing system, available on FDA’s VCRP website, contains electronic and
paper versions of Forms FDA 2512 and 2512a, and we strongly encourage electronic filing
because it is faster and more convenient. A filer will receive confirmation of electronic
filing by email.
We estimate that approximately 95% of respondents will use information technology to
develop their product labels, but also estimates that none of the respondents (0%) will
actually use electronic product labels for their products. The agency also estimates that
about ninety-five percent (95%) of the registrations and ingredient filings will be submitted
electronically in the next three years.
4. Efforts to Identify Duplication and Use of Similar Information
There is no duplication of efforts to collect this information by other federal agencies. FDA
is the only federal agency that requires the specified information to appear on the label or
labeling of every cosmetic product that the agency regulates and is the only agency who
conducts the voluntary cosmetic labeling program.
5. Impact on Small Businesses or Other Small Entities
We estimate that approximately 80% of the establishments that will be affected by the
cosmetic labeling information collection request probably qualify as small businesses with
sales under $5,000,000 per year.

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We set requirements for labeling cosmetic products to the minimum requirements that
comply with the appropriate provisions of the FD&C Act and the FPLA. In most cases, the
information that FDA requires establishments, including small businesses, to disclose is
information that is available to those establishments in the normal course of doing business.
With regard to the VCRP, we estimate that ten percent (10%) of respondents are small
businesses. Small businesses usually can complete Form FDA 2511 just by providing the
company name and address. However, the use of Forms FDA 2512 and FDA 2512a is
expected to increase with the size of the reporting firm, the number of products
manufactured, and the turnover of product lines. We aid small businesses in complying with
its requirements through the agency’s Regional Small Business Representatives and through
the administrative and scientific staffs within the agency. We have provided small business
assistance on the agency’s website at https://www.fda.gov/industry/small-businessassistance.
6. Consequences of Collecting the Information Less Frequently
Respondents update the required labeling information on an occasional basis, associated
with the development and marketing of their products, as required by the FD&C Act and the
FPLA. If the information was not collected, that is, if we did not require this information to
appear on the label or labeling of every cosmetic product that the agency regulates, then the
agency’s ability to enforce the relevant provisions of the FD&C Act and the FPLA would be
nullified, and consumers would be unable to obtain from cosmetic product labels the
information they need to evaluate and use cosmetic products.
Data collection for the voluntary cosmetic registration program also occurs occasionally.
Registrations of cosmetic product establishments are submitted only once and therefore
cannot be collected less frequently. Amended registrations are submitted occasionally, for
example when a cosmetic product establishment site moves or the corporate structure
changes. Original cosmetic product ingredient statements and notices of discontinuance are
submitted only once and therefore cannot be collected less frequently. Amended cosmetic
product ingredient statements are submitted only if a manufacturer changes a cosmetic
product formulation.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), in the Federal Register of April 3, 2020 (85 FR
18993), we published a 60-day notice requesting public comment on the proposed extension
of this collection of information. One comment was received which discussed cosmetic
manufacturers not supplying information about the production of their products, unlisted
ingredients in cosmetics, and proposing mandatory requirements for cosmetic
manufacturers, packers, and distributors to provide a listing of toxic ingredients in their
cosmetics submitted to FDA.
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In response to this comment, we note that under the FD&C Act, cosmetic products and
ingredients, with the exception of color additives, are not subject to premarket approval by
FDA. However, they must not be adulterated or misbranded. This means that they must be
safe for consumers under labeled or customary conditions of use, and they must be properly
labeled. We do not have the authority to review the labels prior to marketing, but companies
and individuals who manufacture or market cosmetics have a legal responsibility to ensure
the safety of their products. Additionally, the label of a cosmetic product must bear a
warning statement whenever necessary or appropriate to prevent a health hazard that may be
associated with the product (§ 740.1(a)). Labels are not expected to list contaminants or
potential byproducts of manufacturing. However, if a product is found not to be in
compliance with the requirements, a cosmetic may be found to be adulterated or misbranded
under the FD&C Act and subject to seizure and removed from the market.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
None of the information required to appear on the label or labeling of cosmetic products that
the agency regulates is confidential.
None of the registration information supplied on Form FDA 2511 is confidential. The
public and other interested parties may request copies under the provisions of the Freedom
of Information Act (FOIA). However, under 21 CFR 720.8, cosmetic product ingredient
filers may request confidentiality of the identity of a cosmetic ingredient if such information
is a trade secret or confidential commercial or financial information as defined in 21 CFR
20.61. Requests for confidentiality are subject to the provisions of 21 CFR 20.111 and 21
CFR 20 subparts D and E. If FDA grants the request, the information is not available for
public disclosure. Confidentiality of the information submitted is protected from disclosure
under FOIA under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of the
agency’s regulations (21 CFR part 20). The information also is safeguarded by section
301(j) of the FD&C Act (21 U.S.C. 331(j)).
Privacy Act
This information collection request (ICR) is collecting personally identifiable information
(PII) or other data of a personal nature. Information is collected via Form FDA 2511
(Registration for Cosmetic Product Establishment) and Form FDA 2512 (Cosmetic Product
Ingredient Statement). Form FDA 2512a (Cosmetic Product Ingredient Statement) is part of
this ICR but no PII is collected. PII collected is name, phone number, and email address for
Form FDA 2511 and Form FDA 2512. PII is collected in the context of the individual’s
professional capacity. This consolidated collection of information involves both the labeling
of cosmetic products and the voluntary registration of cosmetic products to FDA. The
collection of information for this ICR is found in 21 CFR parts 701, 710, and 720.

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We determined that although PII is collected, the collection is not subject to the Privacy Act
of 1974 and the particular notice and other requirements of the Act do not apply.
Specifically, we do not use name or any other personal identifier to retrieve records from the
information collected.
In preparing this supporting statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected.
None of the information required to appear on the label or labeling of cosmetic products that
the agency regulates is confidential.
11. Justification for Sensitive Questions
This information collection does not involve questions of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Third-Party Disclosure Burden1
21 CFR Section; Activity

701.3; ingredients in
order of predominance
701.11; statement of
identity
701.12; name and place
of business
701.13; net quantity of
contents

No. of
Respondents

No. of
Disclosures per
Respondent

Total
Annual
Disclosures

Average
Burden per
Disclosure

1,518

21

31,878

1

31,878

1,518

24

36,432

1

36,432

1,518

24

36,432

1

36,432

1,518

24

36,432

1

36,432

Total
1

Total
Hours

141,174

There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated annual third-party disclosure burden is based on data available to the agency,
our knowledge of and experience with cosmetics, and communications with industry. The
hour burden is the additional or incremental time that establishments need to design and
print labeling that includes the following required elements: a declaration of ingredients in
decreasing order of predominance, a statement of the identity of the product, a specification
of the name and place of business of the establishment, and a declaration of the net quantity
of contents. These requirements increase the time establishments need to design labels
because they increase the number of label elements that establishments must consider when
designing labels. These requirements do not generate any recurring burden per label
because establishments must already print and affix labels to cosmetic products as part of
normal business practices. We estimate that the total third-party disclosure burden is
141,174 hours.

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Table 2.--Estimated Annual Reporting Burden1
21 CFR Section/Part;
Activity

Form

No. of
Respondents

1,702

No. of
Responses per
Respondent
1

Total
Annual
Responses
1,702

Part 710; registrations

25112

720.1 – 720.4; new
submissions
720.6; amendments

25123

6,843

1

6,843

2512

2,477

1

2,477

720.6; notices of
discontinuance
720.8; requests for
confidentiality
Total

2512

232

1

232

1

1

1

Average
Burden per
Response
0.20
(12 mins)
0.33
(20 mins)
0.17
(10 mins)
0.10
(6 mins)
2

Total
Hours

340
2,258
421
23
2
3,044

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There are no capital costs or operating and maintenance costs associated with this collection of information.
2
The term “Form FDA 2511” refers to both the paper Form FDA 2511 and online Form FDA 2511 in the
online system known as the VCRP, which is available at https://www.fda.gov/cosmetics/voluntary-cosmeticregistration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
3
The term “Form FDA 2512” refers to the paper Forms FDA 2512 and 2512a and online Form FDA 2512 in
the online system known as the VCRP, which is available at https://www.fda.gov/cosmetics/voluntarycosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.

We base our estimate of reporting burden hours on information from cosmetic industry
personnel and FDA experience entering data submitted on paper Forms FDA 2511, 2512,
and 2512a into the online system. We estimate that, annually, 1,702 establishments that
manufacture or package cosmetic products will each submit 1 registration on Form FDA
2511, for a total of 1,702 annual responses. Each submission is estimated to take about 0.20
hour per response for a total of 340.4 hours, rounded to 340. We estimate that, annually,
firms that manufacture, pack, or distribute cosmetics will file 6,843 ingredient statements for
new submissions on Forms FDA 2512 and FDA 2512a. Each submission is estimated to
take about 0.33 hour per response for a total of 2,258.19 hours, rounded to 2,258. We
estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 2,477,
amendments to product formulations on Forms FDA 2512 and FDA 2512a. Each
submission is estimated to take about 0.17 hour per response for a total of 421.09 hours,
rounded to 421. We estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 232 notices of discontinuance on Form FDA 2512. Each submission is
estimated to take about 0.10 hour per response for a total of 23.2 hours, rounded to 23. We
estimate that, annually, one firm will file one request for confidentiality. Each such request
is estimated to take 2 hours to prepare for a total of 2 hours. Thus, the estimated total
reporting burden is 3,044 hours.

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12b. Annualized Cost Burden Estimate
We estimate the annualized burden hour cost to respondents for this collection of
information to be approximately $11,932,597.32.
We estimate that the label design process will involve an employee making an average wage
similar that of a Federal government employee at the GS-12/Step-1 rate for the WashingtonBaltimore locality pay area for the year 2020, which is $41.37 per hour. To account for
overhead, this cost is increased by 100 percent, which is $82.74 per hour. Thus, the
estimated cost imposed by third-party disclosures is approximately $11,680,736.76 (141,174
hours x $82.74 per hour).
We estimate that the average hourly wage for the employee preparing and submitting the
registrations and ingredient filings would also be equivalent to a GS-12/Step-1 level in the
locality pay area of Washington-Baltimore in 2020, approximately $41.37/hour. Doubling
this wage to account for overhead costs, we estimate the average hourly cost to respondents
to be $82.74/hour. Thus, the estimated cost incurred by reporting is $251,860.56 (3,044
burden hours x $82.74/hr).

Activity
Label Design Process
Preparation and
submission of registration
and ingredient filing
Total

Table 3.--Annual Cost Burden Estimate
Total Burden
Hourly Wage
Total Respondent Costs
Hours
Rate
144,218
$82.74
$11,680,736.76
3,044
$82.74
$251,860.56

11,932,597.32

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
As part of FDA’s responsibility to enforce the provisions of the FD&C Act and the FPLA,
the agency conducts the Cosmetics Compliance Program to evaluate cosmetic products for
compliance with the labeling requirements. Under this program, FDA’s field offices carry
out investigations, inspections, sample collections, sample analyses, and other compliance
activities, and FDA’s headquarters provides guidance for field office activities. In addition,
we provide advice to representatives of cosmetic establishments and start-up businesses
regarding the labeling requirements for cosmetic products. We estimate that the agency
needs six professional staff persons per year (12,480 hours) to review compliance and
regulatory activities related to cosmetic labeling. Using an hourly cost to the agency of
$41.37 per hour (the GS-12/Step-1 rate for the Washington-Baltimore locality pay area for
the year 2020, increased by 100 percent, which is $82.74 to account for overhead), we

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estimate the annual cost to the Federal government to be $1,032,595.20 (12,480 x $82.74 per
hour).
We have also allocated FTEs to review the submissions and maintain computer files, which
requires about 100 hours annually for registrations and 5,824 hours annually for ingredient
filings, for a total of 5,924 hours annually. We estimate that, on average, the hourly cost for
review and evaluation of the submissions is approximately $41.37 per hour, the GS-12/Step1 rate for the Washington-Baltimore locality pay area for the year 2020. To account for
overhead, this cost is increased by 100 percent, making the total cost $82.74 per hour. Thus,
we estimate the cost to the Federal Government for the review of submissions to be
$490,151.76 ($82.74/hour x 5,924 hours).
Therefore, the total government cost for this collection of information is $1,522,746.96
($1,032,595.20 [labeling] + $490,151.76 [VCRP]).
15. Explanation for Program Changes or Adjustments
The burden for this information collection reflects an overall increase of 3,044 burden hours
and a corresponding increase of 11,255 burden responses due to a revision to consolidate
two similar collections of information. We have consolidated the information collection
provisions from OMB control number 0910-0027 into this collection. Once this collection
has been approved by OMB, we will request for OMB control no. 0910-0027 to be
discontinued.
16. Plans for Tabulation and Publication and Project Time Schedule
The information from this collection will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the
information collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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