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TREACH (KKDIK) BY-LAW (Part 7, Section 2)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SEVENTH PART
Authorization
SECOND SECTION
Authorization
Granting of authorizations
ARTICLE 50 – (1) The Ministry shall be responsible for taking decisions on applications for authorizations in accordance with this Section.
Without prejudice to paragraph 3 provisions of this Article an authorization shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex 14 is adequately controlled in accordance with Section 6.4 of Annex 1 and as documented in the applicant’s chemical safety report. When granting the authorization, and in any conditions imposed therein, the Ministry shall take into account all discharges, emissions and losses, including risks arising from diffuse or dispersive uses, known at the time of the decision.
Paragraph 2 shall not apply to:
- Substances meeting the criteria in Article 47 (1) (a), (b), (c) or (e) for which it is not possible to determine a threshold in accordance with Section 6.4 of Annex 1;
- Substances meeting the criteria in Article 47 (1) (ç) or (d);
- Substances identified under Article 47 (1) (e) having persistent, bio accumulative and toxic properties or very persistent and very bio accumulative properties.
If an authorisation cannot be granted under paragraph 2 or for substances listed in paragraph 3, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. This decision shall be taken after consideration of all of the following elements and taking into account the opinions of the Risk Assessment and the Socio-economic Analysis referred to in Article 54 (4)(a) and (b):
- The risk posed by the uses of the substance, including the appropriateness and effectiveness of the risk management measures proposed;
- The socio-economic benefits arising from its use and the socio- economic implications of a refusal to authorize as demonstrated by the applicant or other interested parties;
- the analysis of the alternatives submitted by the applicant under Article 52(4)(d) or any substitution plan submitted by the applicant under Article 52(4)(e), and any third party contributions submitted under Article 54 (2);
- Available information on the risks to human health or the environment of any alternative substances or technologies.
(5) When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Ministry including:
- Whether the transfer to alternatives would result in reduced overall risks to human health and the environment, taking into account the appropriateness and effectiveness of risk management measures;
- The technical and economic feasibility of alternatives for the applicant.
(6) A use shall not be authorized if this would constitute a relaxation of a restriction set out in Annex 17.
(7) The authorization shall specify:
- The person(s) to whom the authorization is granted;
- The identity of the substance(s);
- The use(s) for which the authorization is granted
- Any conditions under which the authorization is granted;
- The time-limited review period;
- Any monitoring arrangement.
(8) Notwithstanding any conditions of an authorization, the holder shall ensure that the exposure is reduced to as low a level as is technically and practically possible.
Review of authorizations
ARTICLE 51 – (1) Authorizations granted in accordance with Article 50 shall be regarded as valid until the Ministry decides to amend or withdraw the authorization in the context of a review, provided that the holder of the authorization submits a review report at least 18 months before the expiry of the time-limited review period. Rather than re-submitting all elements of the original application for the current authorization, the holder of an authorization may submit only the number of the current authorization, subject to the second, third and fourth subparagraphs.
A holder of an authorization granted in accordance with Article 50 shall submit an update of the analysis of alternatives referred to in Article 52(4)(d), including information about any relevant research and development activities by the applicant, if appropriate, and any substitution plan submitted under Article 52(4)(e). If the update of the analysis of alternatives shows that there is a suitable alternative available taking into account the elements in Article 50(5), he shall submit a substitution plan, including a timetable for proposed actions by the applicant. If the holder cannot demonstrate that the risk is adequately controlled, he shall also submit an update of the socio- economic analysis contained in the original application.
If he can now demonstrate that the risk is adequately controlled, he shall submit an update of the chemical safety report.
If any other elements of the original application have changed, he shall also submit updates of these element(s).
When any updated information is submitted in accordance with this paragraph, any decision to amend or withdraw the authorization in the context of the review shall be taken in accordance with the procedure referred to in Article 54 applied mutatis mutandis.
The Ministry shall set a reasonable deadline by which the holder(s) of the authorization may submit further information necessary for the review and indicate by when it will take a decision in accordance with Article 54. Authorizations may be reviewed at any time if:
- The circumstances of the original authorization have changed so as to affect the risk to human health or the environment, or the socio- economic impact; or
- New information on possible substitutes becomes available.
In its review decision the Ministry may, if circumstances have changed and taking into account the principle of proportionality, amend or withdraw the authorization, if under the changed circumstances it would not have been granted or if suitable alternatives in accordance with Article 50(5) become available. In the latter case the Ministry shall require the holder of the authorization to present a substitution plan if he has not already done so as part of his application or update.
In cases where there is a serious and immediate risk for human health or the environment, the Ministry may suspend the authorization pending the review, taking into account the principle of proportionality.
If an environmental quality standard referred to in relevant legislation on IPPC is not met, the authorizations granted for the use of the substance concerned may be reviewed.
If the environmental objectives as referred to in Article 4 of Bylaw on Water Pollution Control published in Official Gazette dated 31/12/2004 and numbered 25687 are not met, the authorizations granted for the use of the substance concerned in the relevant river basin may be reviewed.
If a use of a substance is subsequently prohibited or otherwise restricted in regulations on persistent organic pollutants, the Ministry shall withdraw the authorization for that use.
Applications for authorizations
ARTICLE 52 – (1) An application for an authorization shall be made to the Ministry through Chemicals Registration System in the website of Ministry.
Applications for authorization may be made by the manufacturer(s), importer(s) and/or downstream user(s) of the substance. Applications may be made by one or several persons.
Applications may be made for one or several substances that meet the definition of a group of substances in Section 1.5 of Annex 11, and for one or several uses. Applications may be made for the applicant’s own use(s) and/or for uses for which he intends to place the substance on the market.
An application for authorization shall include the following information:
- The identity of the substance(s), as referred to in Section 2 of Annex 6 ;
- The name and contact details of the person or persons making the application;
- A request for authorization, specifying for which use(s) the authorization is sought;
- Feeding stuffs within the scope of the Bylaw on Placing on the Market and Use of Feeding Stuffs,
- Food within the scope of the Bylaw on Turkish Food Codex,
- Unless already submitted as part of the registration, a chemical safety report in accordance with Annex 1 covering the risks to human health and/or the environment from the use of the substance(s) arising from the intrinsic properties specified in Annex 14;
- An analysis of the alternatives considering their risks and the technical and economic feasibility of substitution and including, if appropriate information about any relevant research and development activities by the applicant;
- Where the analysis referred to in paragraph (d) shows that suitable alternatives are available, taking into account the elements in Article 50(5), a substitution plan including a timetable for proposed actions by the applicant.
The application may include:
- A socio-economic analysis conducted in accordance with Annex 16;
- A justification for not considering risks to human health and the environment arising either from:
- Emissions of a substance from an installation for which a permit was granted; or
- Discharges of a substance from a point source governed by the requirement for prior regulation.
The application shall not include the risks to human health arising from the use of a substance in a medical device in the scope of Bylaw on Medical Devices published in the Official Gazette dated 07/06/2011 and numbered 27957, Bylaw on Invasive Active Medical Devices published in the Official Gazette dated 07/06/2011 and numbered 27957 and Bylaw on Medical Diagnosis Devices Which Are Used Outside The Body (In vitro) published in the Official Gazette dated 09/01/2007 and numbered 26398.
Subsequent applications for authorization
ARTICLE 53 – (1) If an application has been made for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 52(4)(ç), (d), (e) and (5)(a), provided that the subsequent applicant has permission from the previous applicant to refer to these parts of the application.
If an authorization has been granted for a use of a substance, a subsequent applicant may refer to the appropriate parts of the previous application submitted in accordance with Article 52(4)(ç), (d) and (e) and (5)(a), provided that the subsequent applicant has permission from the holder of the authorization to refer to these parts of the application.
Before referring to any previous application in accordance with paragraphs 1 and 2, the subsequent applicant shall update the information of the original application as necessary.
Procedure for authorization
ARTICLE 54 – (1) The Ministry shall acknowledge the date of receipt of the application. Following the receipt of application, the Ministry shall conduct the Risk Assessment and Socio-economic Analysis referred to in this Article and shall give its draft opinions within ten months of the date of receipt of the application.
The Ministry shall make available on its website broad information on uses, taking into account Articles 60 and 61 on access to information, for which applications have been received and for reviews of authorizations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.
During the process for adoption of authorization decisions in paragraph 1, the Ministry shall first check that the application includes all the information specified in Article 52 that is relevant to its remit. If necessary, the Ministry shall, request to the applicant for additional information to bring the application into conformity with the requirements of Article 52. The Ministry may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies. The Ministry shall also take into account any information submitted by third parties.
The draft opinions shall include the following elements:
- Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;
- Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 52 and of any third party contributions submitted under paragraph 2 of this Article.
(5) The Ministry shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1. Within 60 days of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment.
If the applicant does not send comment to the Ministry in 60 days, the draft opinion will be finalized. After the Ministry takes the written opinion in 60 days, it will finalize its draft opinion in 60 days.
(6) The Ministry shall determine which parts of its opinions and parts of any attachments thereto should be made publicly available on its website.
(7) In cases covered by Article 53(1), the Ministry shall treat the applications together, provided the deadlines for the first application can be met.
(8) The Ministry shall prepare a draft authorization decision within 90 days of the issuance of its opinions. A final decision granting or refusing the authorization shall be taken.
(9) Summaries of the Ministry decisions, including the authorization number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the web-site of the Ministry.
(10) In cases covered by Article 53(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.
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