TREACH (KKDIK) BY-LAW (Part 6, Section 4)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SIXTH PART
Evaluation
FOURTH SECTION
Common Provisions
Registrants' and downstream users' rights
ARTICLE 43 – (1) The Ministry shall notify any draft decision under Articles 36, 37 or 41 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt. If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Ministry in 30 days. The Ministry may amend the draft decision accordingly. In the case that registrants and downstream users don’t notify their potential comments to the Ministry in 30 days from the date of notification, notification decision is deemed to be accepted.
If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Ministry of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use.
The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the decision. In such cases, the registrant, or downstream user, shall inform the Ministry of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report.
The Ministry may request further information for the following(s) in the context of Article 41:
- If a dossier has been prepared under Annex 15 and it was decided to be harmful to the human or environmental health and so a further information is needed;
- If the risk of exposure to the substance manufactured or imported by the registrant or manufactured or imported in an article or used by the downstream user is significantly increasing.
Cost sharing for tests without an agreement between registrants and/or downstream users
ARTICLE 44 – (1) Where registrants or downstream users are required to perform a test as a result of a decision taken under this Part, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Ministry accordingly within 90 days. If the Ministry is not informed of such agreement within 90 days, it shall designate one of the registrants or downstream users to perform the test on behalf of all of them.
If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.
In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the full study report.
The person performing and submitting the study shall have a claim against the others accordingly. Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the full study report of the study performed.
TURKREACH (KKDIK) BY-LAW
- FIRST PART - General Issues
- SECOND PART - Registration of Substances
- FIRST SECTION - Information Requirements and General Obligation to Register
- SECOND SECTION - Substances Regarded as Being Registered Substances
- THIRD SECTION - Obligation to Register and Information Requirements for Certain Types of Isolated Intermediates
- FOURTH SECTION - Common Provisions for All Registrations
- THIRD PART - Data Sharing and Avoidance of Unnecessary Testing
- SIXTH PART - Evaluation
- SEVENTH PART - Authorization
- EIGHTH PART - Restrictions on the Manufacturing, Placing on the Market and Use Of Certain Dangerous Substances, Mixtures and Articles