Or. Admin. Code § 845-025-7160 - Packaging and Labeling Pre-approval Process
(1)
Prior to selling, offering for sale, or transferring a marijuana item or hemp
item that is for ultimate sale to a consumer, patient, or designated primary
caregiver, a licensee, registrant, or Commission-certified hemp handler must
submit both a package and a label application to and receive approval from the
Commission. The initial submission shall be made electronically if required by
the Commission. The licensee, registrant, or Commission-certified hemp handler
must submit a physical prototype upon request by the Commission.
(2) Except as provided in sections (5) to (7)
of this rule, the packaging and label applications must be accompanied by the
following:
(a) A fee as specified in OAR
845-025-1060; and
(b) Information
including but not limited to:
(A)
Documentation that the package has been certified as child resistant as defined
by 16 CFR 1700 by a qualified third-party child-resistant package testing
firm.
(B) A picture of and
description of the item to be placed in the package.
(C) For label applications for inhalable
cannabinoid products that contain non-cannabis additives:
(i) The non-cannabis additive's list of
ingredients as required by 845-025-3265(1); and
(ii) In a form and manner prescribed by the
Commission, information regarding the manufacturer of the non-cannabis
additive, the additive or additives being used by the licensee or
Commission-certified hemp handler, and attestation by the licensee or
Commission-certified hemp handler of the accuracy of the information submitted
for label pre-approval.
(D) For label applications for marijuana
items or hemp items that contain an artificially derived cannabinoid allowed by
OAR 845-025-1310:
(i) The applicable
documentation required by OAR 845-025-1310(1);
(ii) A copy of the food establishment license
issued by the Oregon Department of Agriculture (ODA) to the manufacturer of the
artificially derived cannabinoid; and
(iii) In a form and manner prescribed by the
Commission, citations to the peer reviewed studies as required by OAR
845-025-1310(1), and attestation by the licensee of the accuracy of the
information submitted for label pre-approval.
(3) If a licensee or
Commission-certified hemp handler submits a list of ingredients to the
Commission in order to comply with paragraph (2)(b)(C) of these rules, and the
licensee or Commission-certified hemp handler believes the list of ingredients
is a trade secret, the licensee must mark the information "confidential - trade
secret."
(a) If the Commission receives a
public records request for information submitted by a licensee or
Commission-certified hemp handler, it will review all documents submitted to
determine whether the documents contain trade secrets that would be exempt from
disclosure under Oregon's Public Records Act, ORS 192.345.
(b) For purposes of this rule "trade secret"
has the meaning given that term in ORS 192.345.
(4) The Commission will evaluate the
packaging and label in order to determine whether:
(a) The packaging:
(A) Has been certified as child resistant by
a qualified third-party child-resistant package testing firm.
(B) Is attractive to minors or is marketed in
a manner attractive to minors.
(C)
Contains untruthful or misleading content.
(D) Will contain a marijuana item or hemp
item that is not compliant with ORS 475C, OAR chapter 333, divisions 7 and 8,
or OAR chapter 845, division 25.
(b) The label:
(A) Complies with the labeling rules, OAR
845-025-7000 to 845-025-7190, or any additional labeling requirements in ORS
475C, OAR chapter 333, divisions 7 and 8, or OAR chapter 845, division
25.
(B) Contains any material that
is attractive to minors.
(C)
Contains untruthful or misleading content.
(5) The Commission must review the packaging
and labeling and notify the licensee, registrant, or Commission-certified hemp
handler whether the packaging and labeling is approved, and if not approved, a
description of the packaging or labeling deficiencies.
(6) If a licensee's, registrant's, or
Commission-certified hemp handler's label or package fails to comply with these
rules, it must correct the deficiencies and resubmit the label or package for
pre-approval. Failure to correct the deficiencies within any deadline
established by the Commission will result in the pre-approval application being
considered incomplete.
(a) On and after
January 1, 2025, if a package or label is found deficient for a third time, the
application will be denied and the licensee, registrant, or
Commission-certified hemp handler will be given the right to a hearing under
the procedures in ORS Chapter 183.
(b) Reconsideration. A licensee, registrant,
or Commission-certified hemp handler may submit a written request for
reconsideration of an application's inactivation pursuant to section (6) of
this rule. Such a request must be received by the Commission within 10 days of
the date the inactivation notice was sent to the licensee, registrant, or
Commission-certified hemp handler. The Commission shall give the licensee,
registrant, or Commission-certified hemp handler the opportunity to be heard if
the application is denied pursuant to section (6) of this rule. A hearing under
this section is not subject to the requirements for contested case proceedings
under ORS 183.310 to 183.550.
(c) A
licensee, registrant or Commission-certified hemp handler may resubmit an
application for label or package preapproval at any time, in accordance with
section (2) of this rule.
(7) A licensee, registrant, or
Commission-certified hemp handler may submit packaging and labeling for
approval on the same application for a product that may have different flavors,
colors, or sizes, if the product and packaging is otherwise identical.
Applications for approval of packaging and labeling under this section are
subject to a single application fee.
(8) Packages and labels that have been
previously approved do not need to be resubmitted if the only changes to the
packaging or label are:
(a) Changes in the:
(A) Harvest or processing date;
(B) Strain;
(C) Test results;
(D) Net weight or volume; or
(E) UID numbers.
(b) The deletion of any non-mandatory label
information.
(c) The addition,
deletion, or change in the:
(A) UPC barcodes
or 2D mobile barcodes (QR codes);
(B) Website address, phone number, fax
number, or place of address of the licensee or registrant; or
(C) Instructions for opening or using
child-resistant packages.
(d) The repositioning of any label
information on the package, as long as the repositioning of label information
is consistent with these rules.
(e)
A marijuana wholesaler or a marijuana retailer with an approved usable
marijuana or hemp label may change the producer's business name, trade name, or
license number without resubmission and pre-approval.
(9) Prior to a licensee, registrant, or
Commission-certified hemp handler transferring a package or label approval from
one licensee, registrant, or Commission-certified hemp handler to another, the
licensee, registrant, or Commission-certified hemp handler requesting to
transfer the label must submit a form prescribed by the Commission and pay the
applicable fee as described in OAR 845-025-1060.
(10) The Commission may publish a list of
previously approved, child-resistant, commercially available packaging.
Packaging identified on this list as approved for certain product types does
not need to be submitted for package approval if the packaging is identical to
the previously approved package.
(11) The Commission may publish a list of
licensees, registrants, and Commission-certified hemp handlers who have
approved label applications.
(12)
Labels for marijuana items and hemp items do not require pre-approval if they
are generic labels as defined in OAR 845-025-7000 and contain only the
information required by these rules.
(13) Packages that are not intended to be
child resistant do not require pre-approval. Any package that has not been
certified as child-resistant must contain the statement described in OAR
845-025-7030(20).
(14)
Notwithstanding any provisions of this rule, the Commission may permit or
require electronic submission of labels and packaging for approval.
(15) On or after April 1, 2024, a new package
or label application or a previously approved package or label application that
has been opened by the Commission due to a request for an amendment to an
existing package or label shall be inactivated and the fee collected under OAR
845-025-1060 shall not be refunded if a licensee, registrant, or
Commission-certified hemp handler does not resubmit the application within 365
days of the Commission notifying the licensee, registrant, or
Commission-certified hemp handler of deficiencies with the
application.
Notes
Statutory/Other Authority: ORS 475C.237, ORS 475C.616, 571.337, 475C.604 & 475C.608
Statutes/Other Implemented: ORS 475C.616, 571.337 & 475C.608
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