Mixtures, Manufactured Items and Products

11 Dec 2013

Are you making or importing a mixture? Are you sure? Keep reading more as this is the first of a three-part blog series.

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 first of a three-part series titled "Mixtures, Manufactured Items and Products", we look more closely at mixtures and show that the definition of mixtures is generally quite consistent among some of the significant regulatory jurisdictions.

Canada – Canadian Environmental protection Act (CEPA, 1999)

A substance is defined in CEPA as "any distinguishable kind of organic or inorganic matter, animate or inanimate, and includes (a) any matter that is capable of being dispersed in the environment or of being transformed in the environment into matter that is capable of being so dispersed or that is capable of causing such transformations in the environment; (b) any element or free radical; (c) any combination of elements of a particular molecular identity that occurs in nature or as a result of a chemical reaction; and (d) complex combinations of different molecules that originate in nature or are the result of chemical reactions but that could not practicably be formed by simply combining individual constituents". A mixture is a combination of substances that does not itself produce a substance that is different from the substances that were combined.

Europe - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH):

According to the EU REACH, a substance is "a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition". A mixture consists of several substances.

USA – Toxic Substances Control Act (TSCA)

A chemical substance refers to "any organic or inorganic substance of a particular molecular identity, including any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any chemical element or uncombined radical". A mixture refers to "any combination of two or more chemical substances if the combination does not occur in nature and is not, in whole or in part, the result of a chemical reaction". This definition of a mixture includes:

1. Any combination which occurs, in whole or in part, as a result of a chemical reaction if the combination could have been manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined and if, after the effective date of premanufacture notification requirements, none of the chemical substances comprising the combination is a new chemical substance, and
   
   
2. Hydrates of a chemical substance or hydrated ions formed by association of a chemical substance with water.

What does this mean for industry?

If your company is manufacturing or importing chemical mixtures 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, mixtures themselves are not subject to notification. However, if your substance does not meet the specific jurisdictional definition of a mixture, or any of the components of the mixture are not registered/notified/listed, you may be subject to reporting requirements under CEPA, REACH, TSCA or the Act specific to your jurisdiction of interest.

Do you have questions about regulatory requirements for mixtures or other related topics? Share your comments or questions below and our expert, Joyce Borkhoff, will get back to you.