TREACH (KKDIK) BY-LAW (Part 2, Section 4)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SECOND PART
Registration of Substances
FOURTH SECTION
Duties of Ministry
ARTICLE 20 – (1) The Ministry shall assign a submission number to each registration, which is to be used for all correspondence regarding the registration until the registration is deemed to be complete, and a submission date, which shall be the date of receipt of the registration at the Ministry.
In respect to registration dossier
- The Ministry shall undertake a completeness check of each registration in order to ascertain that all the elements required under Articles 11 and 13 or under Articles 17 or 18 as well as the registration fee referred to in Article 59 have been provided. The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.
- The Ministry shall undertake the completeness check within three weeks of the submission date. If a registration is incomplete, the Ministry shall inform the registrant, before expiry of the three-week period, as to what further information is required in order for the registration to be complete, while setting a deadline for this.
- The registrant shall complete his registration and submit it to the Ministry within the deadline set. The Ministry shall confirm the submission date of the further information to the registrant. The Ministry shall perform a further completeness check, considering the further information submitted.
- The Ministry shall reject the registration if the registrant fails to complete his registration within the deadline set. The registration fee shall not be reimbursed in such cases.
Once the registration is complete, the Ministry shall assign a registration number to the substance concerned and a registration date, which shall be the same as the submission date. The Ministry shall communicate the registration number and registration date to the registrant concerned. The registration number shall be used for all subsequent correspondence regarding registration.
Where additional information for a particular substance is submitted to the Ministry by a new registrant, the Ministry shall notify the existing registrants that this information is available on the database for the purposes of Article 22.
Manufacturing and import of substances
ARTICLE 21- (1)A registrant may start or continue the manufacture or import of a substance or production or import of an article, if there is no indication to the contrary from the Ministry in accordance with Article 20(2) within the three weeks after the submission date, without prejudice to Article 24(8).
In the case of an update of a registration according to Article 22, a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Ministry in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 24(8).
If the Ministry has informed the registrant that he is to submit further information the registrant may start the manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Ministry within the three weeks after receipt by the Ministry of the further information necessary to complete his registration, without prejudice to Article 24 (8).
If a lead registrant submits parts of the registration on behalf of one or more other registrants, as provided for in Articles 12 or 19, any of the other registrants may manufacture or import the substance or produce or import the articles only after the expiry of the time-limit laid down in paragraph 1 or 2 of this Article and provided that there is no indication to the contrary from the Ministry in respect of the registration of the lead registrant acting on behalf of the others and his own registration.
Further duties of registrants
ARTICLE 22 – (1) Following registration, a registrant shall be responsible on his own initiative for updating his registration without undue delay with relevant new information and submitting it to the Ministry in the following cases:
- Any change in his status, such as being a manufacturer, an importer or a producer of articles, or in his identity, such as his name or address;
- Any change in the composition of the substance as given in Section 2 of Annex 6 ;
- Changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;
- New identified uses and new uses advised against as in Section 3.7 of Annex 6 for which the substance is manufactured or imported;
- New knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;
- Any change in the classification and labelling of the substance;
- Any update or amendment of the chemical safety report or Section 5 of Annex 6 ;
- The registrant identifies the need to perform a test listed in Annex 9 or Annex 10, in which cases a testing proposal shall be developed;
- Any change in the access granted to information in the registration.
A registrant shall submit to the Ministry an update of the registration containing the information required by the decision made in accordance with Articles 36, 37, 41 or 50 within the deadline specified in that decision.
The Ministry shall undertake a completeness check of each updated registration according to Article 20(2) (a) and 20 (2) (b). In cases where the update is in accordance with Article 13(2) and with paragraph 1(c) of this Article then the Ministry shall check the completeness of the information supplied by the registrant and Article 20(2) shall apply adapted as necessary.
In cases covered by Articles 12 or 19, each registrant shall submit separately the information specified in paragraph 1(c) of this Article.
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