Or. Admin. Code § 845-025-7160

Current through Register Vol. 63, No. 10, October 1, 2024

Section 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, a license applicant, registrant, or Commission-certified hemp handler must submit both a package and a label application to and receive approval from the Commission.

(a) The initial submission shall be made electronically if required by the Commission. The licensee, license applicant, registrant, or Commission-certified hemp handler must submit a physical prototype upon request by the Commission.

(b) If a license applicant submits packages and labels for pre-approval, final determination for packages and labels will not be made until the applicant has been issued a license.

(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; and

(D) Will contain a marijuana item or hemp item that is not compliant with ORS 475 C, 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 475 C, OAR chapter 333, divisions 7 and 8, or OAR chapter 845, division 25.

(B) Contains any material that is attractive to minors; and

(C) Contains untruthful or misleading content.

(5) The Commission must review the packaging and labeling and notify the licensee, licensee applicant, 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 is deficient, it must correct the deficiencies and resubmit the label or package for pre-approval, but the licensee, registrant, or Commission-certified hemp handler is not required to submit an additional fee unless the label or package is found deficient for a second time in which case the application will be denied and the licensee, registrant, or Commission-certified hemp handler must resubmit the packaging or labeling in accordance with section (1) of this rule.

(7) A licensee, applicant, 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.

Or. Admin. Code § 845-025-7160

OLCC 6-2018, adopt filed 05/23/2018, effective 6/1/2018; OLCC 14-2018, amend filed 12/27/2018, effective 12/28/2018; OLCC 24-2020, amend filed 12/21/2020, effective 12/22/2020; OLCC 21-2021, amend filed 12/30/2021, effective 1/1/2022; OLCC 159-2022, minor correction filed 03/25/2022, effective 3/25/2022; OLCC 202-2022, amend filed 11/21/2022, effective 1/1/2023; OLCC 7-2023, amend filed 11/17/2023, effective 1/2/2024

Statutory/Other Authority: ORS 475C.237, ORS 475C.616, 571.337, 475C.604 & ORS 475C.608

Statutes/Other Implemented: ORS 475C.616, 571.337 & ORS 475C.608