Home/KKDIK Substance Evaluation: Prioritization and Request for Additional Information
KKDIK Substance Evaluation: Prioritization and Request for Additional Information
Substance evaluation is the second part of the evaluation pillar of KKDİK. Dossier evaluation examines the dossier you submit; substance evaluation examines the substance itself and concerns all companies registering it. If the Ministry prioritises a substance, additional information may be requested even when your dossier is complete.
Why is item evaluation done?
The aim is to understand whether the substance poses a risk to human health or the environment, based on existing registration information. The Ministry also uses the information obtained from the file evaluation for this purpose (Art. 38/2). In other words, the two processes feed each other: a doubt arising in the file evaluation can move the item to the prioritization list. See KKDIK file evaluation.
Prioritization criteria (ARTICLE 40)
The Ministry prioritises substances using a risk-based approach that takes three criteria into account:
| Criteria | What to look for |
|---|---|
| Hazardous information | The substance or its transformation products have properties of high concern; persistence and tendency to bioaccumulate; structural similarity to known SVHCs |
| Exposure information | Route of use, distribution, exposed population |
| Tonnage | Including total tonnage of multiple registrants — total by item, not individually |
The third criterion is often overlooked: even if your tonnage is low, the substance can be prioritized if the total tonnage with other companies registering the same substance is high. The structural similarity criterion means that a substance that has never been classified as an SVHC may be listed because it is similar to a known SVHC — see. substance similarity and substances of high concern.
Request for additional information (ARTICLE 41) and deadlines
This is where substance evaluation touches the company. Article 41 regulates the following:
- The scope of the request is wide. The Ministry may request additional information from registrants, including information not specified in Annex-7, Annex-8, Annex-9 and Annex-10. So the standard data set of your tonnage band is not the ceiling.
- The period is determined by the Ministry. The registrant submits the information until the date determined by the Ministry.
- Decision within 12 months. The Ministry reviews all the information provided and takes a decision within 12 months following the submission of additional information.
- The evaluation is completed in 12 months. The Ministry completes the evaluation activities within 12 months from the start of the evaluation of the substance or within 12 months from the notification.
Decision process: 30-day right to comment
The decision under Article 41 is also subject to the procedure in Article 43:
- The Ministry communicates the decision to the relevant registrants and downstream users.
- 30 days are given to submit an opinion.
- If not submitted within the comment period, the decision is deemed accepted.
- The Ministry may amend the decision in line with the comments received.
These 30 days are regularly missed by companies where the notification is lost or lands in the wrong department. It is the cheapest measure to appoint a responsible person to follow up on KKS notifications — see. internal compliance team.
If testing required: 90 days and equal cost sharing
Where a decision requires testing, Article 44 applies: registrants and downstream users agree who will conduct the test and notify the Ministry in writing within 90 days. Otherwise, the Ministry appoints one of them. The cost is shared equally, and the party conducting the test provides everyone with the full study report. A prohibition on manufacturing, importing or placing the substance on the market may be sought against a party that does not pay its share.
The way to predict this cost is to keep communication alive within MBDF with other companies registering the same item. See Cost reduction in MBDF.
Exception and limit for intermediates (ARTICLE 42)
No dossier or substance evaluation is performed for in situ isolated intermediates used under controlled conditions. However, this exemption is not absolute: If the Ministry observes that a risk equal to the risk arising from the use of substances meeting the criteria in Article 47 arises from the isolated intermediate in situ and this risk is not appropriately controlled, it may request additional information from the registrant with written justification.
That is, intermediate status does not provide protection when controlled conditions are not actually met. See intermediates and controlled conditions for details.
Being prepared for evaluation
- Scan your portfolio according to the hazard profile. CMR, PBT/vPvB candidates and substances with structural similarities to them are items at high risk of prioritization.
- Consider the total tonnage, not your own tonnage. Being a junior recorder on a commonly used substance does not exclude you from coverage.
- Retain raw data. Article 32 requires that information be kept available for at least 10 years after the date of last manufacture, import or use of the substance.
- Follow KKS notifications. The 30-day right to comment is lost with silence.
- Strengthen exposure data. This is the second criterion of prioritization; well-documented exposure scenarios reduce risk.
ONAY Mühendislik do?
We score your item portfolio based on the three criteria in item 40 and pre-empt items that are likely to be prioritized; When additional information is requested, we conduct a 30-day opinion letter, testing strategy, and cost sharing negotiation. Contact.
Source: Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals, Sixth Part Second and Third Chapter (ARTICLE 40–42) and ARTICLE 43–44, Official Gazette 23.06.2017 / 30105 bis. Related pages: file evaluation · permission process and Annex-14 · restriction and Annex-17.