Approach for the prioritization of substances on the Revised In Commerce List
The prioritization approach was developed by Health Canada for the prioritization of substances on the Revised In Commerce List (R-ICL). This approach was intended to be protective and risk-based, as well as expedient and pragmatic. The process was risk-based in that readily available information on hazard and exposure was considered together whenever possible (depending upon available information). Substances identified for further consideration will be further refined using a risk-based approach. The approach used recommendations received during multi-stakeholder consultations that took place between 2007 and 2011, experience gained during the categorization of the Domestic Substances List (DSL) and subsequent evaluation of priorities, and experience from assessments conducted on new substances notified under the New Substances Notification Regulations (NSNR) of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
1. Substances previously reviewed
The first step of the prioritization process was to identify those substances on the R-ICL that were also on the DSL, and have either undergone categorization as part of the Chemicals Management Plan (CMP), or else were added to the DSL following notification and assessment under the NSNR as part of the New Substances Program, which is jointly administered by Health Canada and Environment and Climate Change Canada. Since these substances had already undergone a review for their potential risk to human health or the environment, they were not considered further in the R-ICL prioritization process.
Substances on the R-ICL that had been notified under the NSNR but not yet added to the DSL were identified for no further consideration in the context of the R-ICL when the toxicological characteristics, quantities and uses in products regulated under the Food and Drugs Act were thought to be comparable to those identified during the assessment under NSNR and deemed to be of low concern. Alternatively, the assessment under NSNR may identify toxicological or ecotoxicological concerns that support a decision for further consideration.
2. Substances with certain high health or environmental hazard considerations
The second step of the prioritization process was to identify substances having certain high health or environmental hazard considerations. Classifications by national or international agencies or information in pharmaceutical product monographs that identified substances considered to be carcinogenic, genotoxic, or toxic to reproduction were used as hazard flags for substances requiring further consideration. Endocrine disrupters were also considered. Additionally, substances internationally recognized as Persistent Organic Pollutants (POP) were identified. Substances associated with these hazard flags generally required further evaluation to determine whether they posed a significant risk to human health or the environment when their use patterns and environmental exposure were taken into consideration. If reliable information on current and anticipated use pattern and quantities mitigated these hazard concerns such that the substance was unlikely to pose a significant risk to human health or the environment, the substance was identified for no further consideration.
3. Substances from natural sources
This next step involved a qualitative review of substances considered to be from natural sources. Types of substances in this group included natural biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes, and carbohydrates. Also included were certain derivatives of these substances (for example, hydrolysates). Examples of products utilizing these substances range from food products, to cosmetics, to natural health products. Expert judgement in chemistry, toxicology and ecotoxicology was applied to identify substances that were considered unlikely to be persistent or bioaccumulative, or to have significant health or environmental impacts resulting from its use as a product regulated under the Food and Drugs Act. These substances were identified for no further consideration in the R-ICL prioritization process.
4. Potential exposure and use patterns
Exposure is a key factor determining the potential of a substance to harm human health or the environment, as such, can also be used as a rapid screening flag to identify substances for further consideration, or no further consideration. Health Canada used available information on the quantities and use patterns of a substance to characterize potential exposure of the general population and release to the environment. During this analysis, consideration was also given to whether the quantities and use pattern were likely to change in the future. If potential exposure was considered to be negligible and the substance was unlikely to cause harm to human health or the environment, then the substance was identified for no further consideration. For instance, substances no longer in commerce, or known to be in commerce only in limited quantities, and/or with limited defined use patterns, did not warrant further consideration in the R-ICL prioritization process.
If the potential for environmental release or exposure of the general population was considered to be high, then further consideration, particularly regarding potential toxicological hazards, environmental fate, and use pattern, was required to more fully assess the impact of the substance on human health or the environment. Substances in commerce at high quantities, or whose use pattern is likely to result in significant releases to the environment generally required further consideration.
5. Substance groupings
In order to be both comprehensive and pragmatic, prioritization involved identifying groups of substances that could be reviewed together. Substances were grouped based on similar chemical structure, or in the case of micro-organisms, their taxonomical classification, and/or use pattern. Examples of groupings based on chemical structure include quaternary ammonium compounds, alcohol ethoxylates, and substances that contain certain metals. Examples of groupings based on use pattern include pharmaceuticals with similar mechanism of action, or substances used as fragrances. Grouping substances together enabled more efficient information-gathering, and a consistent handling of substances within a group.
6. Remaining substances
For substances that did not obviously fit within any grouping, substance-specific information regarding the properties, toxicity, ecotoxicity, use pattern, quantities, and releases was gathered, and/or modelled and used to inform a prioritization decision. Search criteria for information gathering on these substances was standardized to ensure that there was a systematic approach to research and consistent effort was applied. This information was used in a weight of evidence and precautionary manner to determine whether the substance required further consideration to determine whether it was likely to pose a significant risk to human health or the environment.
Revised In Commerce List contact information
Enquiries related to the prioritization of the R-ICL, including requests for a searchable format of the Table of prioritization results of substances on the Revised In Commerce List, may be directed to the following address:
Environmental Assessment Unit 2
269 Laurier Avenue West, 5th floor, PL 4905B
Ottawa, Ontario K1A 0K9
Or by e-mail to: RICL-LRSC@hc-sc.gc.ca
Please include your full contact information: name, address, phone number and email address.
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