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Packaging and Labeling Pre-Approval

Overview

PLEASE NOTE: The information provided here is only a brief summary of the rules.  There are additional requirements that you must comply with.  You are responsible for complying with OAR 845-025-7000 to 845-025-7190. 
 

The Oregon Liquor Control Commission (OLCC) evaluates and approves medical and recreational marijuana and hemp packages and labels to ensure all packages and labels meet all of the rule requirements.

 
 
 

OLCC Approved Packaging Lists

 
Child Resistance Not Required - Immature Plant and Seed Packaging
 
Online Application approval for Packaging and Labeling of Recreational and Medical Marijuana

Medical & Recreational Marijuana Packaging and Labeling Guide
The guide is designed to help explain the packaging and labeling rules. Please note, this guide should not replace a thorough reading of the rules.  
 
Guide to the Package and Label Pre-Approval Process
 
  
Packaging and Labeling Updates​


New packaging and labeling rules took effect August 15, 2018
, and this document provides an overview of the key changes.  It is not a substitute for licensees having a thorough understanding of the OLCC’s marijuana packaging and labeling rules.
Packaging and Labeling Rule Update


Applications Will Be Denied After Two Failed Attempts

All package and label applications that are submitted on or after August 15, 2018 will be given two submissions to get their application approved by the OLCC.  If the application is not approved in two attempts, the package or label application will be denied and the applicant will have to submit a new application and pay the fee $100 again.

Application Process
An applicant begins the pre-approval process by completing the online application form and paying the $100 fee.  When the application has been correctly submitted the status of the application will change from “Draft” to “New.”  After the OLCC reviews and makes a decision regarding the application, the status will either change to “Approved” or “Resubmission Required.”  If the status is “Approved”, the package or label can be used by the applicant.  If the application status is “Resubmission Required” the applicant must open the application and look for the notes in the system, which explain what changes must be made to the application before it will be approved.  If the applicant resubmits the application without making all of the required changes as listed in the notes or the changes made are not compliant with the rules, the application will be denied.  Once the application is denied, the applicant will be notified.  To get the package or label approved, the applicant will have to start from the beginning, complete a new application, and pay an additional $100 fee. 

Change Requests
Beginning on August 15, 2018, all requests to make changes to an approved package or label application will need to be made by completing the Change Request form and submitting a $25 change fee.  The form must be printed out and mailed into the OLCC with the $25 fee.  Once the OLCC receives the form and payment, it will unlock the application so that changes can be made to the application and resubmitted for approval.

 
 
 
 

Who Needs to Get Pre-Approval for Packaging and Labeling?

All licensees or registrants packaging hemp or marijuana items into individual containers that will be sold to consumers, patients, or caregivers at a dispensary or retail store need to obtain packaging and labeling approval. 
 
      For Recreational Marijuana 
   “Licensee” means any person who holds one of the following OLCC marijuana licenses: Producer, Processor, Wholesaler, Retailer; or Laboratory.
   The packaging and labeling rules only apply to marijuana items for sale to a consumer and do not apply to transfers between licensees.  OLCC Licensees transferring bulk product to another licensee must follow OAR 845-025-7700.  Bulk transfers between licensees do not require package and label approval.
      For Medical Marijuana 
    Registrant” is defined as a medical cannabis producer, grower, marijuana processing site, or a medical marijuana dispensary that has registered with the Oregon Health Authority.
   Registrants packaging and/or labeling products for ultimate sale to a consumer, patient, or designated primary caregiver must receive packaging and labeling approval from the OLCC.
   The packaging and labeling rules only apply to marijuana items for sale to a patient or primary designated caregiver and do not apply to transfers between registrants. 
   The packaging and labeling rules do not apply to a grower transferring usable marijuana or an immature plant to:
    A patient who designated the grower to grow marijuana for the patient; or
    A designated primary caregiver of the patient who designated the grower to grow marijuana for the patient.
   The packaging and labeling rules do not apply to a designated primary caregiver of a patient if the caregiver is transferring a marijuana item to a patient of the designated primary caregiver.
Apply for package and label approval as soon as possible.  Approval may take a few weeks to obtain, and packages and labels must be approved prior to sale to a consumer.
 

   

 

Packaging 

Package applications cover only the physical container holding the marijuana item or an outer container.  All text, logos, pictures, and graphics are considered part of the label and must be submitted as a separate label application.
 
The application fee for a package or label is nonrefundable.  Make sure you understand the rules and requirements before submitting an application because you will not be refunded for submitting the wrong type of application.
 
The Commission evaluates the packaging for all marijuana items for ultimate sale to a consumer, patient, or caregiver.  The packaging must:
1.    Not be attractive to minors;
2.    Not contain any untruthful or misleading information;
3.    Protect the marijuana item from contamination and not impart any toxic or harmful substance to the marijuana item;
4.    Be labeled in accordance with the labeling rules; and
5.    Meet the standards for child-resistance.
Once the OLCC approves a package, it can be used by any licensee or registrant and does not need to be resubmitted for approval.  All packages approved by the OLCC will be added to the pre-approval list on the Packaging and Labeling portion of the OLCC website (see top of page).
 
Child-resistant Packaging  
All marijuana and hemp items, except for immature marijuana plants and seeds, must leave the retail store or dispensary in child-resistant packaging.  The container that holds the marijuana item can be child resistant on its own, but if the container is not child resistant, that container must be placed inside a child-resistant exit package at the point of sale.  
 
In order for the OLCC to consider a package child-resistant, it must be tested and certified as child resistant by a third-party testing firm.  The OLCC does not test packaging for child resistance or determine whether a package meets the child-resistant standards.  Documentation proving the package is certified as child resistant must be included with the package application if the package is to be considered child resistant. 
 
To learn more about child-resistant packaging and find a list of third-party testing firms, please read the guide published by the Consumer Product Safety Commission (CPSC):http://www.cpsc.gov/Regulations-Laws--Standards/Statutes/Poison-Prevention-Packaging-Act/Child-Resistant-and-Senior-Friendly-Packages-packaging-guide/
 
The OLCC does not promote or endorse any of the testing firms in the CPSC guide.  Applicants may use a third-party testing firm that is not included on this list. 
 
There are two types of child-resistant packaging: (1) single-use packages and (2) resealable and continually, child-resistant packages.
 
Single-Use Packages   - child-resistant until opened by the consumer
Ø  Usable marijuana items such as trim, flower, or pre-rolls
Ø  Must be certified as meeting the child-resistant standards (16 CFR 1700) by a third-party testing firm
 
 Resealable and Continually, Child-Resistant Packages – continue to be child-resistant every time the package is opened and reclosed
Ø  All extracts, concentrates, and cannabinoid products must leave the retail store or dispensary in a resealable and continually, child-resistant package
Ø  Must be certified as meeting the child-resistant standards (16 CFR 1700) by a third-party testing firm
 
 
Attractive to Minors
OAR 845-025-7000(1) defines “attractive to minors” as packaging, labeling and marketing that features:
Ø  Cartoons (see OAR 845-025-7000 for definition);
Ø  A design, brand or name that resembles a non-cannabis consumer product of the type that is typically marketed to minors; 
Ø  Symbols or celebrities that are commonly used to market products to minors; 
Ø  Images of minors; or
Ø  Words that refer to products that are commonly associated with minors or marketed by minors.
 

Labeling 

The label includes all text, graphics, pictures, or logos located anywhere on the package.  If the package contains more than one label panel, all the panels are considered as being a part of one label. 
 
The Commission will evaluate a marijuana label to determine whether it is compliant with the rules.  All labels must:
Ø  Contain all required information in any typed, legible font that is easy to read and contrasts sufficiently with the background and is at least 1/16th of an inch in height based on the uppercase “K”;
Ø  Be in English, although it can include text in additional languages;
Ø  Be unobstructed and conspicuous;
Ø  Contain a principal display panel that contains the net weight, universal symbol (or hemp symbol), and product identity; and
Ø  Not contain any untruthful or misleading statements.  
 
Download the universal symbol at this link: https://public.health.oregon.gov/PreventionWellness/marijuana/Pages/symbol.aspx
 
A principal display panel is the portion of the package that is most likely to be seen by the consumer when on display for sale.  The principal display panel must include the following:
 
1.  Product identity – common name for the product that informs consumer what they are purchasing;
2.  Net weight – must be listed in both Metric units (i.e. milligrams or milliliters) and U.S. Customary units (i.e. ounces or fluid ounces); and
3.  Universal symbol – must be in color and at least 0.48 inches wide by 0.35 inches high.
 
Every marijuana product type (e.g., cannabinoid edibles, topicals, or concentrates) has additional specific labeling requirements that must be included on the label. These requirements can be found in OAR 845-025-7000 to 845-025-7190.
 
Failure to include all label information may result in your label application being denied.
 

When Approval is NOT Required

1. Packaging
If you use a package that is published on the OLCC list of approved packages, you will not have to request approval to use the same package.  If any changes are made to the approved packaging, you will need to apply for approval prior to any sale or transfer to a consumer.
  
 
2.  Labeling
A generic label is a label that contains only the information required by rule and does not contain any graphics, photographs, logos, or additional information not required by rule anywhere on the package.  If you are using a generic label, you do not have to get approval from the Commission before using your label. The generic label must contain all of the specific requirements of OAR 333-007-0010 to OAR 333-007-0100. 





Each label includes everything printed on or affixed to the package. In the example shown left, the background, logo, and stars are all a part of the label; therefore the label is NOT generic.
















3.
  Prior Labeling Approval
 
If your label has been previously approved by the Commission, but you want to make changes to the label, you do not need to resubmit the label for approval if you change any of the following:
Ø   Harvest or processing date;
Ø   Strain;
Ø   Test results, which includes lab information and THC/CBD concentration;
Ø   Net weight or volume;
Ø   Harvest, process lot, or UID numbers
Ø   The deletion of any non-mandatory label information
Ø   The addition, deletion, or change in the UPC barcodes or 2D mobile barcodes (QR codes);
Ø   Instructions for opening or using child-resistant packages;
Ø   The addition, deletion, or change in the website address, phone number, fax number, or zip code of the licensee or registrant; or
Ø   The repositioning of any label information on the package as long as the label information is consistent with the labeling rules.
 
 
For more information about packaging and labeling, please read the Packaging and Labeling Guide.  If you have a question, please call 503-872-5459 or send an email to marijuana.packaging@oregon.gov.
 
 
 

Frequently Asked Questions 

Q: Are health claims allowed on a label?
A: It depends. The label cannot contain any claim, picture, or statement implies that the product will have a therapeutic or curative effect.  No claim can be made on a label unless the claim is supported by the totality of publicly available scientific evidence and for which there is significant scientific agreement among experts qualified by scientific training and experience to evaluate such claims.   
 
Q: Where should the ingredient list be placed on an edible label?
A: If a label contains more than one panel, the ingredient list should be placed on the information panel.  The information panel should be to the right of the principal display panel and contain the name and address of the processor, packer, or distributor. If the label one contains one panel (which by default will be the principal display panel), the ingredient list may appear on the principal display panel.  The ingredient list must be a part of the Nutrition Facts panel.
 
Q: Should the common or usual name always be used for the list of ingredients?
A: Always list the common or usual name for ingredients unless there is a rule or OLCC guidance that provides for a different term. For instance, use the term “sugar” instead of the scientific name “sucrose. 
 
Q: How do I list ingredients on my edible label?
A: All ingredients must be listed in descending order of predominance by weight or volume.  Descending order of predominance means that the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last.  You must be sure you are including all ingredients on the label.
 
If you have an ingredient that is made out of other ingredients (i.e., your recipe includes chocolate chips, which are made out of sugar, chocolate, cocoa butter, milkfat, and soy lecithin), you must also list the sub ingredients in the ingredient statement.  The sub ingredients may be declared parenthetically following the name of the ingredient or may be declared by listing each ingredient in its order of predominance in the ingredient statement without naming the original ingredient.
 
Q: According to OAR 333-007-0090(2)(b), labels must comply with the National Institute of Standards and Technology (NIST) Handbook 130 (2016).  What is the NIST Handbook?
A: The NIST Handbook 130 contains guidance for uniform packaging and labeling regulations.  The regulations outlined in the NIST Handbook 130 must be followed when packaging and labeling a marijuana product.  For more information please follow this link: http://www.nist.gov/pml/wmd/pubs/hb130.cfm
 
The NIST Handbook provides the following guidance regarding net weight:
 Ø The net weight should appear in the bottom 30% of the PDP;
Ø The net weight must be parallel to the bottom of the container; and
Ø The net weight units should be expressed in numbers between 1 and 1000 (for example, use 2 grams instead of 2000 milligrams).
Q: Can I use Clean Green Certified on my label?
A: Yes, as long as you have proof of certification.
 
Q: My package is too small to fit all of the labeling requirements.  How do I meet the labeling requirements?
A: OAR 845-025-7030(11) provides that if a container is too small to fit all of the information required that container may have a label that includes at a minimum the following information:
            (1) Net weight, product identity, and universal symbol;
            (2) Business or trade name and license or registrant number;
            (3) The UID number;
            (4) Concentration of THC and CBD; and
            (5) Required warnings:
(a) For a retail marijuana item or industrial hemp commodity or product, the following warning is required on the label: “For use only by adults 21 and older.  Keep out of reach of children.”
(b) For a medical marijuana item, the following warning is required on the label: “For use by OMMP patients only.  Keep out of reach of children.”
 
All other required label information not listed above must be contained on an outer container or package, inside a peel-back or accordion label, or on a hangtag attached to the marijuana or hemp item.  If an outer container is used, all labeling information, including the information listed above, must be on the outer container.
 
Q: Does a vape cartridge need to be labeled? 
A: Yes, all vape cartridges must be labeled with the universal symbol.  The container that the cartridge is sold in must contain a label that meets the requirements set out in the labeling rules.
 
Q:  Can peel back labels be used?
A: Yes.  Peel-back labels and accordion labels can be utilized when using a small container label.  The following information must be visible on the outside of the label:
(1) Net weight, product identity, and universal symbol;
            (2) Business or trade name and licensee or registrant number;
            (3) The UID number
            (4) Concentration of THC and CBD; and
            (5) Required warnings.
 
The remaining information may go inside the peel-back or accordion label as long as the label can easily be identified as containing important information.
 
Q: Does the universal symbol have to be in color?
A: Yes, the universal symbol must be in color.  Your label will not be considered compliant if the universal symbol is in black and white.
 
Packaging Questions
 
Q: Does my packaging need to be opaque?
A: No.  There is nothing in the packaging rules that requires your package to be opaque.
 
Q: If my product is packaged in a container that is child resistant, does it need to be placed in an exit package at the point of sale?
A: No.  The product only needs one layer of child resistant packaging.  If the container holding the item is the correct type of child resistant container, the product does not need to be placed in an exit package.
 
Pre-Approval Process Questions
 
Q: What happens if I need to make a change to my label after it is approved?
A: A label that has been previously approved does not need to be resubmitted if the only changes to the label are changes to the: harvest date; processing date; strain; THC or CBD concentration; test date; batch test number; net weight or volume; harvest lot number; UID number; or process lot number. 
 
If you are switching from being an OHA registrant to an OLCC licensee and will use the same label, you do not need to reapply under your new license number.  If you would like to change your license number in the system or you would like to add your updated label to your approved application, please send an email to marijuana.packaging@oregon.gov.
 
Additionally, you do not need to resubmit your label if you delete any non-mandatory information or if you add, delete or change a UPC barcode; 2D mobile barcode; website address; phone number; or zip code of the licensee or registrant.  If you make any other change to your label, you must resubmit your label to the pre-approval process and pay a $25 application fee. 
 
Q:  I have two packages that I want approved.  Do I need to submit two separate applications?
A: It depends.  If the two packages are the same except for size or color, they may go on the same application.  In order to put two packages on one application, the packages must be made of the same material, be the same shape, and use the same closing mechanism - they must be identical except that there are two different sizes or colors. If the packages are not the same, they must be put on two different applications.
 
If two packages are being used to package one product (for example, a small jar placed inside of a larger box), both packages may be placed on the same application.
 
Similarly, a licensee, applicant or registrant may submit labeling for approval on the same application for a product that has different flavors, colors, or sizes if the product and label are otherwise identical. Applications for approval of packaging and labeling under this section are subject to a single application fee.
 
Q:  I have submitted a package application but I no longer want to go forward with the application process.  Can I get my application fee refunded?
A: No.  The application fee is non-refundable. 
 
Do you have a question that you would like to see on the FAQ?  Send an email to marijuana.packaging@oregon.gov with the question.
 

Packaging and Labeling Workshops 

Workshops were held across the state of Oregon and provided recreational marijuana licensees and medical marijuana registrants with information on guidelines for recreational and medical marijuana packaging and labeling.