Requires food manufacturers to disclose new food additives not reported to FDA.

S3277

SENATE, No. 3277

STATE OF NEW JERSEY

222nd LEGISLATURE

�

INTRODUCED FEBRUARY 2, 2026

Sponsored by:

Senator� MICHAEL L. TESTA, JR.

District 1 (Atlantic, Cape May and Cumberland)

Co-Sponsored by:

Senator Henry

SYNOPSIS

���� Requires food manufacturers to disclose new food
additives not reported to FDA

CURRENT VERSION OF TEXT

���� As introduced.

��

An Act

requiring the disclosure of certain information
regarding food additives and supplementing Title 24 of the Revised Statutes.

����
Be It
Enacted
by the Senate and General Assembly of
the State of New Jersey:

���� 1.��� a.� As used in this act:

���� �Food� means the same as that
term is defined in the �Food, Drug, and Cosmetic Act,� 21 U.S.C. s.301 et seq.,
with the exception of alcohol.

���� �Food additive� means the same
as that term is defined in the �Food, Drug, and Cosmetic Act,� 21 U.S.C. s.301
et seq.

���� �Generally recognized as safe�
or �GRAS� means any substance added to food because it is recognized, among
experts qualified by scientific training and experience to evaluate its safety,
as having been adequately shown to be safe under the conditions of its intended
use through scientific procedure or, in the case of a substance used in food
prior to January 1, 1958, through either scientific procedure or experience
based on prolonged use in food.

���� b.��� For each new use of a
food additive, a manufacturer of food to be sold in this State shall provide
notice to the Department of Health in an annual report, in a form and manner
specified by the Commissioner of Health that includes the following
information:

���� (1) �a signed statement
certifying the claim that a particular use of a substance is exempt from
premarket approval requirements of the �Food, Drug, and Cosmetic Act,� 21
U.S.C. s.301 et seq., because the notifier has determined that such use is
GRAS.� This exemption claim would include:

���� (a) �the name and address of
the reporter or reporting organization;

���� (b) �the date and signature of
a responsible official of the reporter or reporting organization;

���� (c) �the common or usual name
of any GRAS substances reviewed in the report, using an appropriately
descriptive term;

���� (d) �the intended conditions
for the use of any GRAS substance reviewed in the report, including the foods
in which the substance will be used, the amounts or levels of such use in
foods, and the purposes of which the substance will be used, including, when
appropriate, a description of any subpopulation expected to consume such GRAS
substances;

���� (e) �the basis for the
conclusion of the GRAS status, whether by scientific procedure or experience
based on common use in food;

���� (f) �a statement of assurance
that if requested to procure the data that forms the basis of the GRAS
conclusion, the reporter will agree to make the data available to the
commissioner for review and replication electronically or otherwise; and

���� (g) �an opinion as to whether
any of the data in the GRAS report is exempt from disclosure under the federal �Freedom
of Information Act� pursuant to 5 U.S.C. s.552 et seq.

���� (2) �the identity, method of
manufacture, specifications, and physical or technical effect of the notified
substance including:

���� (a) �scientific data about the
identity of the notified substance such as its chemical name, its Chemical
Abstracts Service (CAS) Registry Number, Enzyme Commission number, empirical
formula, structural formula, and quantitative composition;

���� (b) �a description of the
method of manufacture of the GRAS substance in sufficient detail to evaluate
the safety of the notified substance as manufactured;

���� (c) �for a substance of
natural biological origin, the source information such as genus and species,
and any applicable sub-species level information, such as variety, strain;

���� (i) �the part of any plant or
animal used as the source of the GRAS substance; and

���� (ii) �any content of potential
human toxicants.

���� (d) �specifications for
food-grade material; and

���� (e) �when necessary to
demonstrate safety, shall include relevant data and information bearing on the
physical or other technical effect the notified substance is intended to
produce, including the quantity of the notified substance required to produce
such effect.

���� (3) �Dietary exposure to the
notified substance (such as the amount of relevant substances a consumer is
likely to eat or drink as part of a total diet), including:

���� (a) �an estimate of the
dietary exposure to the notified substance that includes exposure from its
intended use and all sources in the diet;

���� (b) �when applicable, an
estimate of dietary exposure to any other substance that is expected to be
formed in or on food because of the use of the notified substance� (such as
hydrolytic products or reaction products);

���� (c) �when applicable, an
estimate of the dietary exposure to any other substance that is present with
the notified substance either naturally or due to its manufacture (such as
contaminants or byproducts);

���� (d) source of any food
consumption data used to estimate dietary exposure, in accordance with subparagraphs
(a) through (c) of this paragraph; and

���� (e) any assumptions made to
estimate dietary exposure, in accordance with clauses (a) through (c) of this paragraph.

���� (4) self-limiting levels of
use in circumstances where the amount of the notified substance that can be
added to human food or animal food is limited because the food containing
levels of the notified substance above a particular level would become
unpalatable or technologically impractical;

���� (5) �for a substance with a
statutory conclusion of GRAS status based on common use in food, evidence of a
substantial history of consumption of the notified substance for food use by a
significant number of consumers prior to January 1, 1958;

���� (6) �a narrative that provides
the basis for the conclusion of GRAS status that includes:

���� (a) �an explanation as to the
reason the data and information in the report provide a basis for the
conclusion that the notified substance is safe under the conditions of its
intended use.� The explanation shall address the safety of the notified
substance, a consideration of all dietary sources and take into account any
chemically or pharmacologically related substances in the diet and identify
what specific data and information reviewed in accordance with this subparagraph
are generally available and not generally available by providing citations to
the list of data and information required of this paragraph;

���� (b) �an explanation of how the
generally available data and information relied on to establish safety in
accordance with subparagraph (a) of paragraph (6) of this subsection provides a
basis for the conclusion that the reported substance is generally recognized,
among qualified experts, to be safe under the conditions of its intended use;

���� (c) �either data and
information that are, or may appear to be, inconsistent with the conclusion of
the GRAS status, or a statement that the available data and information was
reviewed and the reporter is not aware of any data and information that are or
may appear to be, inconsistent with the conclusion of GRAS status;

���� (d) �whether the data and
information in the report is exempt from disclosure under the �Freedom of
Information Act,� a statement that identifies such data and information; and

���� (e) �how there could be a determination
of GRAS status if qualified experts generally do not have access to non-public,
safety-related information.

���� (7) �a list of supporting data
and information in the GRAS notice, including:

���� (a) �a list of all data and
information required by paragraph (6) of this subsection to provide a basis for
the conclusion that the notified substance is safe under the conditions of its
intended use; and

���� (b) �a specification of the
items listed in subparagraph (a) of this paragraph as generally available or
not generally available.��

���� (8) �any previous GRAS
substance notices submitted to the Food and Drug Administration on the reported
substance and any response from the agency; and

���� (9) �all relevant, currently
available safety information on the GRAS substance.

���� c. �The following substances
are exempt from the reporting requirements of subsection a. of this section:

���� (1) �any GRAS substance for
which the Food and Drug Administration has received a GRAS notice and issued a
letter stating that the federal Food and Drug Administration has no questions
regarding the conclusion that the substance is generally recognized as safe
under its intended conditions of use;

���� (2) �any substances recognized
in federal regulations as prior sanctioned or GRAS substances for use in food
or food packaging;

���� (3)
�any food contact substance for which there is an effective premarket
notification demonstrating safety for its intended use;

���� (4) �any substances subject to
regulation approving its intended use for food;

���� (5) �a food ingredient of
natural biological origin that has been widely consumed for its nutrient
properties in the United States prior to January 1, 1958 without known
detrimental effects, which is subject only to conventional processing as
practiced prior to January 1, 1958, and for which no known safety hazard
exists; and

���� (6) �any substance determined
safe to be added to foods by the commissioner.

���� d.��� The provisions of this
section shall not apply to any cottage food operator, as defined by
N.J.A.C.8:24-1.5.

���� e.���� Any person may file a
report to the commissioner under this section.

���� f.���� Data establishing the
general recognition of safety shall be based on publicly available information
and shall not be based on trade secrets.

���� 2.��� a.� The Commissioner of
Health shall adopt rules and regulations, pursuant to the provisions of the
"Administrative Procedure Act," P.L.1968, c.410 (C.52:14B‑1 et
seq.), to effectuate the purposes of this act.

���� b.��� The department shall
publish on its Internet website, and update as appropriate, a searchable
database of the reports submitted pursuant to section 1 of P.L.� ��,c. ���(C.������
) (pending before the Legislature as this bill).� The commissioner shall omit
or redact any portion of the report that has been designated by the submitter
as a trade secret, provided, however, that the data establishing the general
recognition of safety shall not be omitted or redacted.

���� The commissioner may refuse to
publish an incomplete report if the notifier has not corrected any
insufficiency within a time frame to be determined by the commissioner.

���� c.���� The commissioner shall
inform the notifier of when the report submitted pursuant to section 1 of
P.L.��� , c. ���(C.��� ) (pending before the Legislature as this bill) will be
posted on the department�s Internet website.� The commissioner shall, within
six months from the date of receipt, publish the report�s information on the
department�s website.

���� 3.��� a. �A manufacturer shall
not sell, distribute, or offer for sale in this State any food that contains a
new use of a food additive unless the manufacturer fulfills the requirements of
P.L.��� , c.��� (C. ) (pending
before the Legislature as this bill) and any order, rule or regulation adopted
by the Department of Health pursuant thereto.

���� b.��� Each sale or offer for
sale made by a manufacturer in violation of P.L��� c. ���(C.������� ) (pending
before the Legislature as this bill) or any order, rule or regulation made by
the Commissioner of Health pursuant to the provisions of this act, shall be
subject to a penalty of up to $1,000 for a first offense and up to $5,000 for
each subsequent offense to be collected in a civil action by a summary
proceeding under the "Penalty Enforcement Law of 1999," P.L.1999,
c.274 (C.2A:58-10 et seq.).� If the violation is of a continuing nature, each
day during which it continues constitutes an additional, separate, and distinct
offense.� The Department of Health may institute a civil action in a court of
competent jurisdiction for injunctive or any other appropriate relief to
prohibit and prevent a violation of the provisions of this act or any rule or
regulation adopted, or order issued, pursuant thereto, and the court may
proceed in the action in a summary manner. �The Commissioner of Health shall be
entitled to the assistance of the Attorney General in the enforcement of this
act.�

���� 4.��� This act shall take
effect on the first day of the thirteenth month following enactment, except
that the Commissioner of Health may take any anticipatory action in advance as
shall be necessary for the implementation of the act.

STATEMENT

���� This bill requires
manufacturers of food and nonalcoholic beverages for sale in this State to
disclose certain additive information to the Commissioner of the Department of
Health to be made publicly available.

���� Under the bill, every
manufacturer of food and nonalcoholic beverages for sale in this State is
required to disclose when a new additive has been deemed �generally recognized
as safe� (GRAS) by that entity, and is planned for use in food and non-alcoholic
beverages.� Under sections 201(s) and 409 of the federal �Food, Drug, and
Cosmetic Act,� any substance that is intentionally added to food is a food
additive, subject to premarket review and approval by the U.S. Food and Drug
Administration (FDA), unless the substance is generally recognized among
qualified experts as having been adequately shown to be safe under the
conditions of its intended use, or unless the use of the substance is otherwise
excepted from the definition of a food additive.

���� This bill requires industry to
provide the Commissioner of Health with the premarket review rendering an
additive GRAS, in the form of an annual report with certain requirements, for
publication on the Department of Health Internet website.� The department is to
review and publish the report within six months of receipt. �The commissioner
may refuse to publish an incomplete report, after the submitting entity has
been given an opportunity to correct any insufficiency within a reasonable
time, to be determined by the commissioner.� The bill requires the commissioner
to promulgate rules and regulations for the collection of these reports and the
publication of the data on the department�s Internet website.� It is the
sponsor�s view that the publication of a manufacturer�s food additive
assessment will enable the public to make an informed decision regarding their
consumption choices.

���� Finally, the bill provides for
the use of the �Penalty Enforcement Law of 1999�, P.L.1999 ,c.274 (C.2A:58-10
et seq.), in carrying out the bill�s provisions and makes available to the
Commissioner of Health the assistance of the Attorney General in recovering
penalties, including enforcing an injunction to protect the public interest. �The
penalties are up to $1,000 for a first offense and up to $5,000 for each
subsequent offense.� For a violation of a continuing nature, each day
constitutes an additional, separate and distinct offense.

���� The bill becomes effective one
year after enactment, but permits the Commissioner of Health to take
anticipatory action.