T-4- 116 – Regulatory requirements for products that are or contain polymers
The purpose of this document is to provide guidance regarding regulatory requirements for products that are polymers or contain polymers, whether naturally derived or synthetic, when represented as fertilizers or supplements, under the Fertilizers Act.
2. Registration requirement
polymers are materials made of long, repeating chains of molecules. The materials have unique properties, depending on the type of monomers being bonded and how they are bonded.
Fertilizer or supplement products that are or contain polymers require registration under the Fertilizers Act prior to importation or sale in Canada.
A polymer that affects the performance of a fertilizer or supplement product is itself considered a supplement. As such, whether it is sold alone or in combination with a fertilizer or supplement (as a coating for example) it requires registration prior to importation or sale in Canada unless:
Mixtures containing polymers are exempt from registration only if:
- each product is registered for the proposed use of the mixture
- the directions for use of the mixture are consistent with those of the registered product (for example, target crop, use pattern, application rate, frequency and method) and
- all active ingredients in the mixture are either registered for the proposed use of the mixture or are exempt from registration (for example, materials on the List of Primary Fertilizer and Supplement Materials)
- if the directions for use of a registered product are not consistent with the proposed use of the mixture, the final mixture must be registered
- if the mixture contains a product that requires registration but is not registered, then the mixture requires registration
- the product proponent is responsible for ensuring that all ingredients in their products are compliant with the regulations – this includes ensuring that registered ingredients maintain valid registrations. If a product is being sold as an exempt mixture that contains a registered a product, and the registered product's registration lapses or is cancelled, then the previously exempt product would no longer meet all requirements of the mixtures exemption, and would be out of compliance and subject to enforcement action.
All regulated products must adhere to prescribed standards as outlined in Trade memorandum T-4-93 with respect to the product's composition and contaminant levels.
4. Registration application and labelling
For general guidance on submitting applications for product registration, please consult the Guide to Submitting Applications for Registration under the Fertilizers Act. General labelling requirements are outlined in Trade memorandum T-4-130.
active ingredient means an ingredient of a fertilizer or supplement to which its performance as a fertilizer or supplement is attributed.
Polymers that are active ingredients must be guaranteed as a minimum percentage in the final product formulation by weight. The description of the polymer must be in agreement with the corresponding Chemical Abstract Service Registry Number (CAS RN) listing.
Products that are or contain polymers require a full safety assessment (Level III) and are reviewed on a case-by-case basis.
5. Safety data requirements
Safety data requirements specific to polymers/products containing polymers include:
- Toxicological hazard characterization:
- for the polymer(s)
- for other active and inert ingredient(s)
- for the residual monomers, cross-linkers, catalysts, and any potential degradation products (where applicable)
If the polymer, any of its ingredients or degradation products meet the hazard criteria outlined in Appendix 4; or are recognized to exhibit (potential) carcinogenicity, mutagenicity, reproductive toxicity, developmental toxicity, teratogenicity or endocrine disruption activity, an exposure assessment for the intended use must be provided. Mitigating factors such as recommended personal protective equipment and precautionary statements should be included in the exposure assessment.
- Process of manufacturing or extraction:
- relative proportions of monomer(s), cross-linker(s), and catalysts used in the manufacturing process.
- analytical results to demonstrate the residual levels of these compounds in the final product.
- Food-safety assessment:
- Provide a scientific rationale and/or data to address the risk of uptake and incorporation of monomers, cross-linkers and any degradation products in the edible portion of food crops.
- Where applicable, existing upper tolerances for foods (for example, acrylamide) must be addressed by inclusion in the rationale or risk assessment.
If the product containing a polymeric supplement that is not intended for use on food-crops, or if food safety is not adequately substantiated, the statement, "not for use on food crops" is required to appear prominently on the marketplace label.
6. Research authorization for novel supplements
Research Authorization must be obtained from the CFIA prior to environmental release of any novel supplement for experimental purposes. A supplement that is not registered for the use pattern being tested and not exempt from registration or that contains a novel trait is considered a "novel". For information on how to obtain a research authorization please consult T-4-103.
7. Contact information
Fertilizer Safety Section
Canadian Food Inspection Agency
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