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Guidance on How to Develop a NAFTA Label
Regulatory Language for NAFTA Labels
Harmonized Container/Base Label
U.S. and Canadian Directions-for-Use Booklets
Regulatory Language for NAFTA Labels
This section provides information on how to develop a NAFTA label. Generic issues with the format and regulatory language for a NAFTA label have been worked out. However, developing NAFTA labels for existing products presents unique issues resulting from differences in how the products are currently labeled in the two countries and fitting larger NAFTA labels on the very small containers of some existing products.
As more labels are worked through the process and their associated issues are addressed this information will be updated. If, when considering your specific label, issues arise that are not addressed here, please contact the appropriate contact within EPA, PMRA, or TPD.
The preferred format for a NAFTA label is a harmonized container (base) label with two separate booklets, one for the United States and one for Canada, that contain the country-specific directions for use. We are working collectively to develop a more cost-effective strategy to deliver product booklets.
Questions often arise concerning the requirement in Canada for a bilingual, English and French, label. Thus far, this has been handled in one of two ways.
- In one case, the English portion of the NAFTA container label is on one side of the container and the French portion is on the other.
- In the other case, there is a side-by-side presentation of the English and the French on the container label.
In both cases, the Canadian directions-for-use booklet is produced in both English and French.
Harmonized Container/Base Label
- The following statement should appear prominently at the top of the container/base label and should be contained within a box:
IMPORTANT NOTICE
This product is registered in both the U.S. and Canada
It has BOTH U.S. and Canadian Labeling
You must follow ONLY the U.S. label WHEN USING THIS product in the U.S.
You must follow ONLY the Canadian label WHEN USING THIS product in Canada
This product is registered in both the U.S. and Canada
It has BOTH U.S. and Canadian Labeling
You must follow ONLY the U.S. label WHEN USING THIS product in the U.S.
You must follow ONLY the Canadian label WHEN USING THIS product in Canada
- The container label/base label (affixed panel) must contain the following information based on U.S. and Canadian requirements:
- Name of the pest control product, which may include a brand or trademark, and may include both the U.S. and Canadian brand names (in the case of existing products). In cases where two brand names are included, the label may include a designation showing which one applies in the United States and which in Canada by including the words, “in the U.S.” and “in Canada” under the respective brand names. This may be helpful in the United States when obtaining state registrations, although some states may consider this a new product and require a separate registration.
- Product Type (descriptive of product purpose; it may be included as part of the product name, brand, or trademark), e.g., Herbicide, Fungicide, Insecticide, etc. It may be useful to follow the product type (or the Use Classification—see below) by an explanation that more details may be found in the Directions-for-Use Booklet. The explanation might be “See the appropriate U.S. or Canadian "Use Directions," for example, “Granular Herbicide for Fall or Spring Treatment in Conventional and Direct Seeding Systems to Control Wild Oats in labeled crops. See the appropriate U.S. or Canadian Use Directions.”
- Physical form of the product.
- “READ THE LABEL BEFORE USING”/”READ ATTACHED BROCHURE (or LEAFLET) BEFORE USING.”
- Precautionary Information/Hazard Information.
- The Ingredient statement/Guarantee statement should use the following format:
- The Net Weight/Net Quantity statement should use the following format:
- Use Classification, if applicable/Product Class Designation
- DOMESTIC—requires “KEEP OUT OF REACH OF CHILDREN” on principal display panel
- COMMERCIAL, e.g., “AGRICULTURAL - See the appropriate U.S. or Canadian Use Directions”
- RESTRICTED (Note: RESTRICTED class products are not eligible for NAFTA labeling at this time)
- MANUFACTURING
- Name and U.S. address of the producer or registrant. Only the U.S. address is required, but emergency contact numbers for Canada and the United States must be provided and must be clearly identified and correct. In Canada, the phone number for inquiries is also required.
- First aid information (if certain hazard criteria are met):
- Acceptable statements,
which satisfy both U.S. and Canadian requirements, - The only harmonization issues that might arise for first aid statements are for products containing petroleum distillates, zinc, and the organophosphates—these product would have to be looked at on a case-by-case basis.
- U.S. Registration. Number and Pest Control Product Act (PCPA) Registration Number
- EPA Establishment Number
- The U.S. Worker Protection Standard (WPS) statement, which should be the following statement contained in a box:
The language and symbols used may be either the more restrictive of the U.S. and Canadian requirements or those that would be required under the Globally Harmonized System of Labelling (GHS).
Active Ingredients/Guarantee:
Common Name/CAS Name:
List of Ingredients and percent:
Net Contents XXXX U.S. Units/XXXX Canadian Units
For example, Net Contents 1,000 lbs./453.60 kgs
Product Class Designations:
United States AGRICULTURAL USE REQUIREMENTS: Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR Part 170. Refer to supplemental labeling under “Agricultural Use Requirements” in the Directions for Use section for information about this standard.
- The statements:
- In the United States: It is a violation of U.S. law to use this product without having obtained the U.S. label at the time of purchase and following the U.S. label at the time of application.
- In Canada: NOTICE TO USER: This pest control product is to be used only in accordance with the directions on the label. It is an offence under the PCPA to use this product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons or property that arises from any such use of this product.
- Both the Storage and Disposal Statements should be included if there is space on the container label. In most cases, the storage statement is the same in the United States and Canada and the disposal information is very different. Thus, two formats may be acceptable:
- A single storage statement followed by two separate statements for U.S. and Canadian disposal requirements
- Two completely separate U.S. and Canadian storage and disposal statements
- The environmental hazard statements will be looked at on a case-by-case basis. In general, any parts concerning toxicity should be harmonized, and one statement should be included on the container label. Any parts of the environmental hazard statements that concern only how the product is to be used or mitigation measures should be included in the respective U.S. and Canadian booklets and referenced on the container label.
U.S. and Canadian Directions-for-Use Booklets
- All labeling should contain the following statements prominently at the beginning of the respective U.S. and Canadian Booklets:
- “U.S. LABEL— It is a violation of U.S. law to use this product in the U.S. in a manner inconsistent with its U.S. labeling.”
- “CANADIAN LABEL— It is a violation of Canadian law to use this product in Canada in a manner inconsistent with its Canadian labeling.”
- Each page (for fold-out labels the entire sheet may be considered a single page) of the labeling must have, preferably in the upper right hand corner, the following:
- “U.S. Label” (for U.S. labeling)
- “Canadian Label” (for Canadian labeling)
- All information that was harmonized for inclusion on the container label should be used where the same information is repeated in the booklets. This includes:
- Ingredient statement
- Precautionary language and symbols
- First aid statements
- The toxicity part of the environmental hazard statement
- The storage statement