Are you making or importing a mixture? Are you sure?
A note of caution to all you formulators and importers out there – the regulatory definition of mixtures, manufactured items and products can differ depending on the jurisdiction, and there may be reporting requirements that apply to your material or substance of interest. In this second of a three-part series titled "Mixtures, Manufactured Items and Products", we look more closely at manufactured items and show that the definition of manufactured items is generally quite consistent among some of the significant regulatory jurisdictions.
A manufactured item is defined under CEPA 1999 as an item that is "formed into a specific physical shape or design during manufacture and has, for its final use, a function or functions dependent in whole or in part on its shape or design". Manufactured items that undergo subsequent chemical reactions may be excluded if they:
Fluids (e.g., gases, liquids, waxes, solutions and suspensions) and particles (e.g., dusts, powders, dispersions, granules, lumps, flakes and aggregates of unspecified size) are not considered items, even if the usefulness of the product depends on the particle's shape."
The increased attention being given to manufactured items in Canada under the Chemicals Management Plan and the specific reporting requirements under the 2012 Domestic Substances List Inventory Update for manufactured items "intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual" (sound familiar?), leads one to wonder how manufactured items will be addressed moving forward. Stay tuned…
EU REACH incorporates the term article which is "an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition". REACH includes requirements for articles that are important to understand. Most significantly, a producer or importer of an article has to register the substance(s) within an article if the substance is intended to be released during normal and reasonably foreseeable conditions of use and if the total amount of that substance exceeds one tonne per annum per producer or importer.
TSCA defines the term manufactured item as being that:
except that fluids and particles are not considered articles regardless of shape or design."
If your company is manufacturing or importing manufactured items in Canada, Europe or the US, you may be subject to different regulatory requirements, depending on the regulatory definition. Compliance to regulatory requirements begins with correct identification of your product. Within Canada, Europe or the US, manufactured items themselves are not subject to notification. However, if your manufactured item contains chemical substances designed to be used or released, you may be subject to reporting requirements under CEPA, REACH, TSCA or the Act specific to your jurisdiction of interest.
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Today's expert blogger is Joyce Borkhoff. Joyce is the Director of the Intertek Chemicals Group and is well known for her ability to effectively characterize and communicate the impacts of the regulatory environment on the chemical industry. She is frequently invited to contribute to trade magazines and to present her advice and experience to a wide range of SME and large multi-national audiences. Her technical and regulatory experience and her deep knowledge of the Chemical Industry, makes Ms. Borkhoff uniquely qualified to provide practical, best-in-class service to help meet and understand Global Chemicals Management requirements.