KKDIK File Evaluation: Compliance Check and Test Offer

File evaluation is the part of the evaluation leg, which is the second column of KKDIK, closest to the company. The job does not end with submitting your registration: The Ministry examines the submitted registration files and takes a binding decision for the files it finds incomplete or incompatible. This page describes the two legs of dossier evaluation — suitability check and test proposal review.

File evaluation and item evaluation are not the same thing

Item evaluation is a separate process; For details, see KKDIK substance evaluation page.

Compatibility check: at least 5% of files are selected

The fourth paragraph of Article 37 of the Regulation sets a clear basis: The Ministry selects a certain percentage of the registration files it receives, not less than 5% for each tonnage band, for compliance control purposes.

So the control is not random, but a guaranteed rate in each tonnage band. Since the number of files is low in high tonnage, the probability of a company being selected increases significantly in the upper bands. For data requirements for tonnage bands, see tonnage band and data requirements.

What does the Ministry verify?

According to the first paragraph of Article 37, the examination is carried out under four headings:

• Compliance of the technical file — Compliance with Articles 11, 13 and 14 and Annex-3, Annex-6, Annex-7, Annex-8, Annex-9 and Annex-10. See how to prepare a technical file.
• Justification for adaptations — if you deviate from the standard information requirements, does your justification comply with the rules in Annexes 7 to 10 and the general rules in Annex 11? Files using QSAR and read-across are tested here.
• Chemical safety assessment — Compliance of the chemical safety report with Annex-1 and adequacy of the proposed risk management measures.
• Grounds for separate presentation — if you departed from the joint registration and provided the information separately (art. 12/3 or 19/2), is there an objective basis for this statement?

Which files are given priority?

The Ministry gives priority to some files when selecting the sample. The most important of these are files containing information separated from the common record and presented separately. The practical implication is clear: if you choose to opt out of joint recording and submit individually in MBDF, your file will move forward in the queue for review. The justification for this choice must be solid and in writing — see. leader, partner and individual registration.

Test proposal review (ARTICLE 36)

A proposal to carry out a new test under Annex 9 or Annex 10 is reviewed separately. Article 36 provides for the Ministry to examine every testing proposal included in a registration dossier or downstream user report.

The review focuses in particular on substances that are or may be: PBT, vPvB, sensitizing and/or CMR — or substances with widespread use and uses resulting in exposure in excess of 100 tonnes per year.

Article 39 of the regulation has set a milestone in terms of time: Draft decisions of test proposals received until 31/12/2023 will be prepared by 31/12/2025.

What happens when the decision comes?

1. The draft decision is notified (art. 43). The Ministry transmits the decision within the scope of Article 36, 37 or 41 to the registrants and downstream users and gives 30 days for comment.
2. Silence for 30 days is considered acceptance. If you do not submit your opinion within the deadline, you will be deemed to have accepted the decision. This is the most missed point in the calendar.
3. The decision can be amended. The Ministry can change the decision in line with the opinions received.
4. Information must be submitted by the deadline. A compliance-check decision specifies the information needed to bring the registration into compliance and the deadline for providing it (Article 37(2)–(3)). The decision may be adopted within 12 months of the start of the check.
5. The registration is updated. In accordance with the second paragraph of Article 22, the registrant makes the update containing the information required by the decision within the period specified in the decision.

How is the cost shared if the decision requires a test?

Under Article 44, where a decision requires testing, registrants and downstream users must agree who will conduct the test and notify the Ministry in writing within 90 days. If no notification is made, the Ministry appoints one of the parties. The cost is shared equally among the parties concerned, and the party conducting the test provides the others with a copy of the full study report.

For a party that does not pay its share or does not provide a copy of the report, other parties may request that that person be prohibited from manufacturing, importing or placing on the market the substance. For data sharing disputes, see data sharing disputes.

Preparing your file for compliance checking

• Write down the justification for each adaptation (read-across, QSAR, weighted evidence) with reference to Annex 11.
• Harden item ID section — SID vulnerability is the most common remediation request issue.
• Verify that risk management measures are consistent with exposure scenarios in the KGR.
• If you left the joint registration, attach the justification document to the file.
• Schedule post-registration Article 22 update obligations; File evaluation does not end on the registration day.

ONAY Mühendislik do?

It checks your registration file according to the four headings in Article 37 before presentation, and matches the adaptation reasons with Annex-11 rules; Once the decision is notified, we will administer the 30-day comment period and complete the requested information. Contact.

Source: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, Chapter Six, First Chapter (ARTICLE 36–39) and ARTICLE 43–44, Official Gazette 23.06.2017 / 30105 bis. Related pages: substance evaluation · permission process · KKDIK Regulation.