UFIs and PCN are becoming a constant in Chemical regulations. We have covered the topic of what is an UFI code, how are UFI and PCN connected, empty UFIs, multiple times when you need to create a new UFI code (part 1, part 2, part 3), and so on.
However, we have not covered the case of requiring a new UFI if non-hazardous substances are added to a hazardous mixture.
CLP Regulation Nr. 1272/2008, Article VIII states:
''A new UFI shall be created when a change in the composition of the mixture or group of mixtures fulfils one or more of the conditions laid down in points (a), (b) and (c) of the fourth indent of the first subparagraph of Section 4.1 of Part B or, as the case may be, one or other of the conditions laid down in the second subparagraph of that Section.
(a) addition, substitution, or deletion of one or more components in the mixture that shall be indicated in accordance with Section 3.3;
Section 3.3.:
The following mixture components shall be indicated:
(1) mixture components classified as hazardous on the basis of their health or physical effects which:
- are present in concentrations equal to or greater than 0,1 %,
- are identified, even if in concentrations lower than 0,1 %, unless the submitter can demonstrate that those components are irrelevant for the purposes of emergency health response and preventative measures;
(2) mixture components not classified as hazardous on the basis of their health or physical effects which are identified and present in concentrations equal to or greater than 1 %.
(b) change in the concentration of a component in the mixture beyond the concentration range provided in the original submission;
(c) the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in Table 4.''
If we summarize:
- If you add >=0,1% of hazardous substance into the mixture, you must create new UFI.
- If you add >=1% non-hazardous substance into the mixture, you must create new UFI.
If you are still puzzled, just send me a quick email at spela.hudobivnik@bens-consulting.eu and I will help you out.