[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3621 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 3621
To amend title VI of the Federal Food, Drug, and Cosmetic Act to
provide for greater transparency with respect to fragrance and flavor
ingredients in cosmetics, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 24, 2023
Ms. Schakowsky (for herself, Ms. Matsui, Ms. Norton, Ms. Tlaib, Ms.
Velazquez, Mr. Grijalva, Mr. Johnson of Georgia, and Ms. Meng)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend title VI of the Federal Food, Drug, and Cosmetic Act to
provide for greater transparency with respect to fragrance and flavor
ingredients in cosmetics, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Cosmetic Fragrance and Flavor
Ingredient Right to Know Act of 2023''.
SEC. 2. COSMETIC REGULATION.
(a) Definition.--Section 201(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(i)) is amended by adding at the end the
following: ``Such term includes such an article that is intended for
consumer sale or professional use (as defined in section 617).''.
(b) Regulation.--Chapter VI of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 361 et seq.) is amended--
(1) by inserting before section 601 the following:
``Subchapter A--Adulterated and Misbranded Cosmetics'';
(2) in section 602, by adding at the end the following:
``(g) If the fragrance and flavor ingredient information required
to be disclosed pursuant to sections 615 and 616 is not disclosed in
accordance with such sections.
``(h) If its packaging fails to include any fragrance or flavor
ingredient present in such cosmetic or the website of the brand owner
of such cosmetic fails to disclose any such fragrance or flavor
ingredient.''; and
(3) by adding at the end the following:
``Subchapter B--Fragrances and Flavors
``SEC. 615. WEBSITE DISCLOSURE OF INGREDIENTS.
``(a) In General.--Effective beginning on the date that is 1 year
after the date of the enactment of the Cosmetic Fragrance and Flavor
Ingredient Right to Know Act of 2023, a brand owner shall disclose in
an electronically readable format on the website of the brand owner,
and make available to any relevant internet vendor, with respect to
each cosmetic sold or offered for sale in interstate commerce by such
brand owner, the following information:
``(1) A full listing of each ingredient present in such
cosmetic, including each fragrance or flavor ingredient present
in such cosmetic, in descending order of predominance.
``(2) Any fragrance or flavor ingredient present in such
cosmetic that is specified in section 616(b), listed in
descending order of predominance, followed by a link to the URL
of any list on which such ingredient appears.
``(3) In the case of a fragrance allergen in such cosmetic
that meets the criteria specified in section 616(c), the
following statement: `This product contains the following
fragrance allergens.'.
``(4) The functional purpose served by each such fragrance
or flavor ingredient.
``(5) A link to the hazard communication safety data sheet
for any such cosmetic intended for professional use.
``(b) Updates.--In the case of an update to any of the lists
specified in subsection (b) or (c) of section 616 with respect to a
cosmetic sold or offered for sale in interstate commerce by a brand
owner, the brand owner shall revise the disclosure made under
subsection (a) to reflect such update not later than 7 months after the
date on which such update is formally noticed by the authoritative body
who administers the list.
``SEC. 616. COSMETIC INGREDIENT PRODUCT LABEL DISCLOSURE.
``(a) In General.--Effective beginning on the date that is 2 years
after the date of the enactment of the Cosmetic Fragrance and Flavor
Ingredient Right to Know Act of 2023, for purposes of section 602(h),
the packaging or labeling of a cosmetic shall include--
``(1) A full listing of each ingredient present in such
cosmetic (including each fragrance or flavor ingredient),
listed in descending order of predominance.
``(2) In the case of a cosmetic in which any ingredient
specified in subsection (b) is present, the following
statement: `For health impacts related to the fragrance or
flavor ingredients in this product, visit: www.____.'. The
uniform resource locator of the website of the brand owner
shall be placed in the space identifying the website.'.
``(3) In the case of a fragrance allergen in such cosmetic
that meets the criteria specified in section 616(c), the
following statement: `This product contains the following
fragrance allergens.'.
``(4) Not later than 18 months after the date on which an
update to any of the lists referred to in subsection (b) or (c)
with respect to an ingredient or allergen present in such
cosmetic are formally noticed by the authoritative body who
administers the list, any necessary revisions with respect to
such ingredient or fragrance allergen to reflect such update.
``(b) Ingredients Specified.--The ingredients specified in this
subsection are the following chemicals (including chemicals included in
any list specified in this subsection after the date of the enactment
of this subchapter):
``(1) Chemicals for which a reference dose or reference
concentration has been developed based on neurotoxicity in the
Environmental Protection Agency's Integrated Risk Information
System.
``(2) Chemicals that are identified as carcinogenic to
humans, likely to be carcinogenic to humans, or as group A, B1,
or B2 carcinogens, in the Environmental Protection Agency's
Integrated Risk Information System.
``(3) Persistent, bioaccumulative, and toxic Priority
Chemicals identified by the Environmental Protection Agency's
National Waste Minimization Program as of February 22, 2016.
``(4) Chemicals that are identified in volumes 1 through 4
of the Reports on Human Exposure to Environmental Chemicals
issued by the Centers for Disease Control and Prevention (and
any updates to such reports).
``(5) Toxic pollutants listed under section 20 307(a)(1) of
the Federal Water Pollution Control Act and priority pollutants
identified in appendix A to part 423 of title 40, Code of
Federal Regulations (or successor regulations).
``(6) Chemicals classified as `Persistent, Bioaccumulative
and Toxic' by the Toxics Release Inventory published by the
Environmental Protection Agency pursuant to section 313 of the
Emergency Planning and Community Right-to-Know Act of 1986.
``(7) Chemicals that are identified in the Agency for Toxic
Substances and Disease Registry's Toxic Substances Portal.
``(8) Chemicals that are hazardous substances, as such term
is defined in section 101(14) of the Comprehensive
Environmental Response, Compensation, and Liability Act of
1980.
``(9) Reproductive and developmental toxicants identified
by monographs issued by the National Toxicology Program Center
for the Evaluation of Risks to Human Reproduction.
``(10) Chemicals that are identified as known to be, or
reasonably anticipated to be human carcinogens by the most
recent Report on Carcinogens prepared by the National
Toxicology Program pursuant to section 301(b)(4) of the Public
Health Service Act.
``(11) Chemicals identified as persistent, bioaccumulative,
and toxic (PBT) chemicals by the Department of Ecology of the
State of Washington (WAC 173-333 (2006)).
``(12) Chemicals specified in Chapter 6.6 of the California
Safe Drinking Water and Toxic Enforcement Act of 1986 (sections
25249.5 through 25249.14 of the California Health and Safety
Code), List of Reproductive and Developmental Toxicants and
Carcinogens.
``(13) Chemicals for which primary maximum contaminant
levels have been established and adopted under section 64431,
64444, or 64444.5 of division 22 of title 26 of the California
Code of Regulations and chemicals for which notification
levels, as defined in section 116455 of the California Health
and Safety Code, have been established by the California State
Water Resources Control Board.
``(14) Chemicals identified as toxic air contaminants under
section 93000 or 93001 of title 17 of the California Code of
Regulations.
``(15) Substances classified as carcinogens, mutagens or
reproductive toxicants in Appendices 1 through 6 of Annex XVII
to Regulation (EC) No. 1907/2006 of the European Union's
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) law, as revised by the Commission Regulation
(EU) 2020/2096 of 15 December 2020.
``(16) Chemicals included in the European Union Candidate
List of Substances of Very High Concern in accordance with
Article 59 of the REACH Regulation (EC) No. 1907/2006 on the
basis of fulfilling the criteria defined in Article 57(f) for
endocrine disrupting properties.
``(17) Chemicals included in such European Chemicals Agency
Candidate List of Substances of Very High Concern on the basis
of fulfilling the criteria defined in Article 57(d), Article
57(e), or Article 57(f) for persistent, bioaccumulative and
toxic, or very persistent and very bioaccumulative, properties.
``(18) Chemicals classified by the European Union in Annex
VI to Regulation (EC) No. 1272/2008 as respiratory sensitizer
category 1.
``(19) Chemicals that are identified as persistent,
bioaccumulative, and inherently toxic to the environment by the
Canadian Environmental Protection Act Environmental Registry
Domestic Substances List pursuant to subsection 66(1) of the
Canadian Environmental Protection Act, 1999.
``(20) Group 1, 2A, or 2B carcinogens identified by the
International Agency for Research on Cancer of the World Health
Organization.
``(21) Chemicals that are identified on Part A of the list
of Chemicals for Priority Action prepared by the Oslo and Paris
Conventions for the Protection of the Marine Environment of the
North-East Atlantic.
``(22) Chemicals that are skin sensitizers and irritants
classified by Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and
mixtures, amending and repealing Directives 67/548/EEC and
1999/45/EC, and amending Regulation (EC) No 1907/2006.
``(c) Fragrance Allergens.--A fragrance allergen specified in this
subsection is an allergen that is--
``(1) included in Annex III of European Union Cosmetics
Regulation No. 1223/2009, as required to be disclosed pursuant
to European Union Detergents Regulation No. 21648/2004
(including any subsequent updates to those regulations); and
``(2) present in--
``(A) a rinse-off cosmetic at a concentration at or
above 0.01 percent; or
``(B) a leave-on cosmetic product at a
concentration at or above 0.001 percent.
``(d) Master List.--
``(1) In general.--Not later than 6 months after the date
of the enactment of the Cosmetic Fragrance and Flavor
Ingredient Right to Know Act of 2023, the Secretary shall--
``(A) establish a master list of the chemicals that
appear on the lists specified in subsections (b) and
(c);
``(B) post such master list on a publicly available
website of the Food and Drug Administration; and
``(C) establish a voluntary electronic distribution
list to which cosmetic manufacturers and other
interested parties may subscribe to receive a copy of
the master list and any subsequent updates.
``(2) Updates.--
``(A) In general.--The Secretary shall maintain the
master list established under paragraph (1) and make
updates to such list as necessary.
``(B) Notification.--Not later than 30 days after
making an update pursuant to subparagraph (A), the
Secretary shall notify subscribers to the electronic
distribution list referred to in paragraph (1)(C) of
that update.
``(C) Semi-annual updates.--Not less frequently
than twice per year, the Secretary shall publish on a
publicly available website of the Food and Drug
Administration a list of updates to the master list
made during the preceding 6-month period that includes
summaries of any chemicals added to or removed from the
lists specified in subsections (b) and (c).
``SEC. 617. DEFINITIONS.
``In this subchapter:
``(1) Brand owner.--The term `brand owner' means the entity
responsible for bringing a cosmetic to market for retail
consumer sale or professional use.
``(2) Electronically readable format.--The term
`electronically readable format' means, with respect to
information, that the information provided--
``(A) is machine readable by automated systems,
including, web browsers, accessibility software to aid
the disabled, automated scripts, and other software
programs or applications;
``(B) is not restricted from access by search
engines;
``(C) is not restricted from access by a
requirement for registration, the provision of
personally identifiable information, or the use of
CAPTCHA or similar challenge response test
technologies, whether visual, auditory, or otherwise;
and
``(D) conforms to the most current version of the
Web Content Accessibility Guidelines adopted by the Web
Content Accessibility Guidelines Working Group of the
World Wide Web Consortium.
``(3) Flavor ingredient.--The term `flavor ingredient'
means, with respect to a cosmetic, any intentionally added
substance or complex mixture of aroma chemicals, flavor
chemicals, natural essential oils, and other functional
ingredient or ingredients, including the constituent
ingredients of botanicals, for which the purpose is to impart a
flavor or taste, or to counteract a flavor or taste.
``(4) Fragrance ingredient.--The term `fragrance
ingredient' means, with respect to a cosmetic, any
intentionally added substance or complex mixture of aroma
chemicals, natural essential oils, and other functional
ingredient or ingredients for which the purpose is to impart an
odor or scent, or to counteract an odor.
``(5) Ingredient.--The term `ingredient' means a chemical
in a cosmetic, including--
``(A) a chemical that has a technical or functional
effect in the cosmetic, including the breakdown
products of an intentionally added chemical that also
have a functional or technical effect in the cosmetic;
``(B) a substance that is present by reason of
having been added to a cosmetic during processing for
the substance's technical or functional effect;
``(C) a fragrance, flavor, preservative, or
colorant (and the components thereof); and
``(D) any individual component that the Secretary
deems to be an ingredient for purposes of this
subchapter.
``(6) Professional use.--The term `professional use'
means--
``(A) the application of a cosmetic to a human
customer or client that is intended only for use by an
employee or contractor, in settings such as
cosmetology, nail care, barbering, esthetics, spa, and
other professions as determined by the Secretary
through regulation; or
``(B) the use by, or application to, a human of a
cosmetic purchased from a hair salon, nail salon,
beauty salon, spa, or other establishment that provides
cosmetic treatment services for humans.''.
<all>