UVCB Substances under REACH
Tzvi Levinson and Gil Dror, Adv.
REACH sets up a comprehensive system for the manufacturing and use of substances in the EU. The main focus of the new system is the registration of substances. Substances subject to registration cannot be manufactured and / or placed on the market unless the registration requirements are complied with.
The first step in carrying out the registration requirements is to identify the individual substances manufactured or imported and placed on the market. This is not necessarily an easy task. The Regulation itself is a voluminous document of more than 800 pages. As it gives rise to a series of complicated obligations for the authorities the industry and the EU institutions, it is accompanied by Technical Guidance Documents known as RIPs (REACH Implementation Projects). In other words the required reading on REACH comes up to 1000s of pages.
In the case of substance identification industrialists should consult RIP 3.10 – Guidance on Identification and Naming of Substances under REACH. Starting with the definition of "substance" we see that a substance may include additives, solvents and impurities. However this is conditional on certain conditions laid out in the definition. If these conditions are not met, then these may constitute substances on their own which might be subject to separate registration.
As to the categories of substances, RIP3.10 distinguishes between two types: (a) Substances of well defined composition, consisting of mono-constituent and multi-constituent substances; and (b) Substances of Unknown or Variable Composition, Complex reaction products or Biological Materials (UVCB).
The process of identification of UCVB substances is quite complicated. Indications of procedures that may be followed include:
(a) the chemical name, its origin and the process of manufacturing,
(b) other relevant information, e.g. Color index number
(c) chromatographic fingerprint
What are these substances, and how should they fit into the framework of the regulations? These issues are discussed in the article.