Substance identity - screening of the registration dossiers
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1 Substance identity - screening of the registration dossiers Missing and unclear information 30 April 2014 Laszlo Majoros European Chemicals Agency
2 Substance identity IT screening campaign Scope defined by 10 Issue types: 1. Missing concentration ranges 2. Typical concentration outside of concentration range 3. Composition reported with no constituents 4. Low or ambiguous degree of purity for well-defined substances 5. Unidentified constituent or impurity present at significant concentration 6. Well-defined substance with inconsistency between degree of purity and constituent concentrations 7. Well-defined substance with inconsistency between degree of purity and impurity concentrations 8. No spectral and analytical information provided 9. Additives without stabilising function 10. Inconsistent identifiers of constituents, impurities and additives 29 April
3 Issue types observed during the IT screening Missing information Issue type 1: Missing concentration ranges Issue type 3: Composition reported with no constituents Issue type 8: No spectral and analytical information provided Unclear information Issue type 4: Low or ambiguous degree of purity for well-defined substances Issue type 5: Unidentified constituent or impurity present at significant concentration Issue type 9: Additives without stabilising function 29 April
4 Please note that, in general, the examples in this presentation are invented to illustrate and explain the different issue types better. Please note that these examples have been created without any practical or scientific considerations.
5 Issue type 1: Missing concentration ranges
6 Issue type 1: Missing concentration ranges Excerpt from the information letter: Missing concentration ranges The composition with name xxxxxx" and local UUID xxxxxxxxxxxxxxxxxxxxxxxx" contains the constituent with reference substance name xxxxxx" and IUPAC name xxxxxx" for which the concentration range has not been provided. 29 April
7 Section 1.2 Composition Issue type 1: Missing concentration ranges 29 April
8 Issue type 1: Missing concentration ranges Section 1.2 Composition 29 April
9 Issue type 1: Missing concentration ranges Section 1.2 Composition 29 April
10 Issue type 3: Composition reported with no constituents
11 Issue type 3: Composition reported with no constituents Excerpt from the information letter: Composition reported with no constituents IUCLID section 1.2 does not contain any constituents identified by reference substances. 29 April
12 Issue type 3: Composition reported with no constituents Section 1.2 Composition 29 April
13 Issue type 3: Composition reported with no constituents Section 1.2 Composition 29 April
14 Issue type 8: No spectral and analytical information provided
15 Issue type 8: No spectral and analytical information provided Excerpt from the information letter: No spectral and analytical information provided Section 1.4 in your technical dossier does not seem to contain an attachment in a paperclip, which suggests that your registration may not include all the required spectral and analytical information. 29 April
16 Issue type 8: No spectral and analytical information provided Section 1.4 Analytical information 29 April
17 Section 1.4 Analytical information Issue type 8: No spectral and analytical information provided You are expected to attach the document by clicking the paperclip buttons shown here. 29 April
18 Issue type 4: Low or ambiguous degree of purity for well-defined substances
19 Issue type 4: Low or ambiguous degree of purity for well-defined substances Excerpt from the information letter: Low or ambiguous degree of purity provided for well-defined substances An unexpectedly low or wide degree of purity has been provided for the composition with name xxxxxx" and local UUID "xxxxxxxxxxxxxxxxxxxxxxxx". 29 April
20 Issue type 4: Low or ambiguous degree of purity for well-defined substances Section 1.2 Composition 29 April
21 Issue type 5: Unidentified constituent or impurity present at significant concentration
22 Issue type 5: Unidentified constituent or impurity present at significant concentration Excerpt from the information letter: Unidentified constituent or impurity present at significant concentration The composition with name xxxxxx" and local UUID "xxxxxxxxxxxxxxxxxxxxxxxx" contains the constituent with reference substance name xxxxxxxxxxxxxx" and IUPAC name "xxxxxxxxxxxxxx" which is present at a significant concentration, but for which no numerical substance identifiers (EC or CAS number) have been provided and for which the chemical name allows no conclusion to be drawn on its identity. 29 April
23 Issue type 5: Unidentified constituent or impurity present at significant concentration Example 1, Well-defined substances Section 1.2 Composition 29 April
24 Issue type 5: Unidentified constituent or impurity present at significant concentration Example 2, UVCB substances Section 1.2 Composition See further information in chapter 2.1, figure 5 of the Data Submission Manual Part 18 How to report the substance identity in IUCLID 5 for registration under REACH. 29 April
25 Issue type 9: Additives without stabilising function
26 Issue type 9: Additives without stabilising function Excerpt from the information letter: Additives without stabilising function The composition with name xxxxxx" and local UUID "xxxxxxxxxxxxxxxxxxxxxxxx" contains the additive with reference substance name xxxxxxx" and IUPAC name xxxxxxx that has a technical function that does not appear to be compatible with stabiliser. 29 April
27 Issue type 9: Additives without stabilising function Section 1.2 Composition 29 April
28 Issue type 9: Additives without stabilising function Section 1.2 Composition 29 April
29 Issue type 9: Additives without stabilising function Example of incorrectly reported solvent 29 April
30 Issue type 9: Additives without stabilising function Example of correctly reported solvent 29 April
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