News regarding the annual audit of products for The Netherlands
4 January 2018
Suppliers are advised that following discussions held between Cefas, NOGEPA and SSM during 2016/17, a new approach was agreed with regards to findings highlighted during the annual audit of products being used on the Netherlands Continental Shelf. A range of follow-up actions are to be carried out depending on the nature of the findings; these are presented in table 1 below.
Table 1: Audit follow-up actions
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Finding |
Reasoning |
Remark |
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Delivery of data |
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1 |
Delivery of requested data to Cefas beyond deadline |
Warning |
Lateness will compromise audit report, but reports will still be checked upon receipt |
See also item 2 |
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2 |
Non -delivery of requested data to Cefas following a Warning (required reports that were not received) |
A |
No means to judge whether the registration is based on relevant information. Operators not in control of necessary protective measures. Workers might be exposed |
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Reports |
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3 |
No unambiguous link between test report and HOCNF An issue here indicates that the supplier has quoted the report number incorrectly on the HOCNF. |
B |
Alone, it is not a serious issue but it is one which Cefas currently require to be corrected within 10 days |
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4 |
Received test report does not match with the information in the HOCNF form |
Request correct report |
Probable admin error by supplier. |
If otherwise, issues will be found under #3, #6, 7-11 |
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Laboratories |
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5 |
Incorrect Laboratory name “Incorrect” is defined as not matching that on the HOCNF. An issue here is frequently the result of a laboratory takeover or rename in the period since the report was issued. |
B |
Alone, it is not a serious issue but it is one which Cefas currently require to be corrected within 10 days |
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6 |
Tests that are described in the reports were not carried out according to Good Laboratory Practice (GLP) |
A |
GLP is an OSPAR requirement* |
*Historic reports rated Klimisch 1 or 2 also acceptable |
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Tests/End-Points |
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7 |
Identity of the substance, tested by the laboratory, does not demonstrably match the product/component described in the HOCNF form |
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See text below |
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8 |
Minor anomalies in determination of end points (i.e. deviations from test protocol that are not expected to have affected the result of the test) |
Supplier informed |
Action recommended to help supplier’s future improvement. |
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9 |
Serious anomalies in determination of end points (i.e. deviations from test protocol that are expected to have affected the result of the test) a) Anomalies that are expected to have affected the overall assessment of the product (i.e. template affected) |
A |
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10 |
b) Anomalies that are not expected to have affected the overall assessment of the product (i.e. template not affected) |
Warning |
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11 |
Wrong protocol applied NOTE: Applicable only where the actual test methodology is incorrect. Certain test protocols carry alternative designations. |
A |
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HOCNF |
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12 |
Test data transferred incorrectly: Correct transfer would have resulted in the same registration |
B |
Alone, it is not a serious issue but it is one which Cefas currently require to be corrected within 10 days |
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13 |
Test data transferred incorrectly: Correct transfer would have resulted in another categorization |
B |
A serious issue but it is one which Cefas currently require to be corrected within 10 days |
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14 |
Data not included Best defined as “data present in test report but not HOCNF, that is relevant but not necessarily significant re. overall assessment”. a) Excluded data affect interpretation of results
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A |
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b) Excluded data do not affect interpretation of results
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No action |
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A = Registration revoked, unless complete and correct data is delivered within 6 months. No re-registration without complete and correct data. Serious problem. Test invalid. Timescale should allow for retesting.
B = Registration revoked, unless complete and correct data is delivered within 10 days. No re-registration without complete and correct data. Administrative error requiring simple solution.
Specifically with regards to test substance characterisation (item 7), according to the new approach agreed, a test substance is henceforth considered as adequately characterised simply if its CAS number/EC number and chemical name are provided on the test report. This decision has been made so that Cefas’ approach to this issue should be aligned as closely as possible with the stance taken by ECHA in the context of the REACH Regulation.
On the occasions where test substance characterisation fails to meet the above requirement (stage 1), suppliers will be notified to retrospectively submit additional information on the substance tested in accordance with the ECHA guidance (stage 2). If suppliers are still unable to provide the information necessary to characterise the test substance, the decision to accept/reject a test report will be made on a case-by-case basis (stage 3).
Finally, individual feedback will be provided to each chemical supplier if their product was selected for audit during 2017. Cefas aims to complete this by the end of January 2018; however, suppliers may receive notification of requirements to re-test (if applicable) in advance of this.
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