TREACH (KKDIK) BY-LAW (Part 2, Section 1)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SECOND PART
Registration of Substances
FIRST SECTION
Information Requirements and General Obligation to Register
Placing of the substances on the market
ARTICLE 6 – (1) Subject to Articles 7, 8 and 21, substances on their own, in mixtures or in articles shall not be manufactured or placed on the market unless they have been registered in accordance with the relevant provisions of this Part where this is required.
General obligation to register substances on their own or in mixtures
ARTICLE 7 – (1) Save where this Regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in one or more mixture (s), in quantities of one tonne or more per year shall submit a registration to the Ministry through Chemicals Registration System in the website of Ministry.
(2) For monomers that are used as on-site isolated intermediates or transported isolated intermediates, Articles 17 and 18 shall not apply.
(3) Any manufacturer or importer of a polymer shall submit a registration to the Ministry for the monomer substance(s) or any other substance(s), that have not already been registered by an actor up the supply chain, if both the following conditions are met:
- The polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s);
- The total quantity of such monomer substance(s) or other substance(s) makes up one ton or more per year.
Registration and notification of substances in articles
ARTICLE 8 – (1) Any producer or importer of articles shall submit a registration to the Ministry through Chemicals Registration System in the website of Ministry for any substance contained in those articles, if both the following conditions are met:
- The substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
- The substance is intended to be released under normal or reasonably foreseeable conditions of use.
Any producer or importer of articles shall notify the Ministry through Chemicals Registration System in the website of Ministry, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 47 and defined in the article 49 if both the following conditions are met:
- The substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
- The substance is present in those articles above a concentration of 0,1 % weight by weight (w/w);
Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal. In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.
The information to be notified shall include the following:
- The identity and contact details of the producer or importer as specified in section 1 of Annex 6, with the exception of their own use sites;
- The registration number(s) referred to in Article 20(1), if available;
- The identity of the substance as specified in sections 2.1 to 2.3.4 of Annex 6;
- Classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex 6;
- A brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex 6 and of the uses of the article(s);
- The tonnage range of the substance(s) (1-10 tonnes; 10-100 tonnes; 100-1000 tonnes and more than 1000 tonnes)
The Ministry may take decisions requiring producers or importers of articles to submit a registration, for any substance in those articles, if all the following conditions are met:
- The substance is present in those articles in quantities totalling over one ton per producer or importer per year;
- The Ministry has grounds for suspecting that:
- The substance is released from the articles, and
- The release of the substance from the articles presents a risk to human health or the environment;
- the substance is not subject to paragraph 1
Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.
Paragraphs 2, 3 and 4 of this Article shall apply six months after a substance is identified in accordance with Article 49(1).
Only representative
ARTICLE 9 – (1) A natural or legal person established outside Turkey who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Turkey may by mutual agreement appoint a natural or legal person established in the Turkey to fulfil, as his only representative, the obligations on importers under the scope of this Bylaw. Only representative shall also comply with all obligations of importers under this Regulation.
The representative shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 32, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 27.
If a representative is appointed in accordance with paragraphs 1 and 2, the non-resident manufacturer in Turkey shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Bylaw.
Exemption from the general obligation to register for product and process orientated research and development (PPORD)
ARTICLE 10 – (1) Articles 6, 7, 8, 17, 18 and 21 shall not apply for a period of five years to a substance manufactured in the Turkey or imported for the purposes of product and process orientated research and development by a manufacturer or importer or producer of articles, by himself or in cooperation with listed customers and in a quantity which is limited to the purpose of product and process orientated research and development.
For the purpose of paragraph 1, the manufacturer or importer or producer of articles shall notify the Ministry of the following information:
- The identity of the manufacturer or importer or producer of articles as specified in section 1 of Annex 6,
- The identity of the substance, as specified in section 2 of Annex 6,
- The classification of the substance as specified in section 4 of Annex 6, if any,
- The estimated quantity as specified in section 3.1 of Annex 6,
- The list of customers referred to in paragraph 1, including their names and addresses.
The Ministry shall check the completeness of the information supplied by the notifier and Article 20 (2) shall apply adapted as necessary. The Ministry shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Ministry, and shall forthwith communicate that number and date to the manufacturer, or importer, or producer of articles concerned.
The Ministry may decide to impose conditions with the aim of ensuring that the substance or the mixture or article in which the substance is incorporated will be handled only by staff of listed customers as referred to in paragraph 2(d) in reasonably controlled conditions, in accordance with the requirements of legislation for the protection of workers and the environment, and will not be made available to the general public at any time either on its own or in a mixture or article and may ask the notifier to provide additional necessary information. Also, The Ministry may re-collect remaining quantities following the exemption period.
In the absence of any indication to the contrary, the manufacturer or importer of the substance or the producer or importer of articles may manufacture or import the substance or produce or import the articles not earlier than two weeks after the notification.
The Ministry may decide to extend the exemption period by a further maximum of five years or, in the case of substances to be used exclusively in the development of medicinal products for human or veterinary use, or for substances that are not placed on the market, for a further maximum of ten years, upon request if the manufacturer or importer or producer of articles can demonstrate that such an extension is justified by the research and development program.
Information to be submitted for general registration purposes
ARTICLE 11 – (1) A registration required by Article 7 or by Article 8(1) or (5) shall include all the following information:
A technical dossier including:
- The identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex 6,
- The identity of the substance as specified in section 2 of Annex 6,
- Information on the manufacture and use(s) of the substance as specified in section 3 of Annex 6; this information shall represent all the registrant's identified use(s). This information may include, if the registrant deems appropriate, the relevant use and exposure categories,
- The classification and labelling of the substance as specified in section 4 of Annex 6,
- Guidance on safe use of the substance as specified in Section 5 of Annex 6,
- Study summaries of the information derived from the application of Annexes 7 to 11,
- Robust study summaries of the information derived from the application of Annexes 7 to 11,
- an indication as to which of the information submitted under (3), (4), (6), (7) or subparagraph (b) has been reviewed by an chemical assessment expert chosen by the manufacturer or importer and certified according to Annex 18 of this Bylaw,
- Proposals for testing where listed in Annexes 9 and 10,
- For substances in quantities of 1 to 10 tons, exposure information as specified in section 6 of Annex 6,
- A request as to which of the information in Article 61(2) the manufacturer or importer considers should not be made available to the public access and a justification as to why publication together with it could be harmful for his or any other concerned party's commercial interests.
A chemical safety report when required under Article 15, in the format specified in Annex 1. (The relevant sections of the chemical safety report may include, if the registrant considers appropriate, the relevant use and exposure categories.)
Save the cases in the scope of Article 23(3), Article 24(7) or Article 26(3), the registrant shall have the legal ownership or the right to refer to the summarised full study report intended for registration according to paragraphs (a)(6) and (a)(7).
Joint submission of data by multiple registrants
ARTICLE 12 – (1) When a substance is intended to be manufactured by one or more manufacturers and/or imported by one or more importers, and/or is subject to registration under Article 8, the following shall apply:
- Being subject to paragraph 3, the information specified in Article 11(1)(a), (4), (6), (7) and (9), and any relevant indication under Article 11(1)(a), (8) is firstly presented by the lead registrant acting with the agreement of the other assenting registrant(s). After this, each registrant shall subsequently present the information specified in Article 11(1)(a), (1), (2), (3) and (10) and the indication under Article 11(1)(a), (8).
- The registrants may decide themselves whether to submit the information specified in Article 11(1)(a), (5) and 11(1)(b), and any relevant indi-cation under Article 11(1)(a), (8) separately himself or whether by the lead registrant.
Each registrant need only comply with paragraph 1 for items of information specified in Article 11(1)(a), (4), (6), (7) and (9) that are required for the purposes of registration within his tonnage band in accordance with Article 13.
A registrant may submit the information referred to in Article 11(1)(a), (4), (6), (7) or (9) separately if:
- It would be disproportionately costly for him to submit this information jointly; or
- Submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
- He disagrees with the lead registrant on the selection of this information.
(4) If the registrant complies with the provisions under paragraph 3, he submits his justification with the register file.
Information to be submitted depending on tonnage
ARTICLE 13 – (1) The technical dossier referred to in Article 11(1)(a) shall include under points (6) and (7) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
- The information specified in Annex 7 for substances meeting at least one of the criteria specified in Annex 3, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
- The information on physicochemical properties specified in Annex 7, section 7 for substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex 3;
- The information specified in Annexes 7 and 8 for substances manufactured or imported in quantities of 10 tons or more per year per manufacturer or importer;
- The information specified in Annexes 7 and 8 and testing proposals for the provision of the information specified in Annex 9 for substances manufactured or imported in quantities of 100 tons or more per year per manufacturer or importer;
The information specified in Annexes 7 and 8 and testing proposals for the provision of the information specified in Annex 9 and 10 for substances manufactured or imported in quantities of 1000 tons or more per year per manufacturer or importer; .
As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Ministry in twenty working days of the additional information he would require under paragraph 1.
This Article shall apply to producers of articles adapted as necessary.
General requirements for generation of information on intrinsic properties of substances
ARTICLE 14 – (1) Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex 11 are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across). Testing in accordance with Annex 8, Sections 8.6 and 8.7, Annex 9 and Annex 10 may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex 11.
(2) These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
(3) Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the Bylaw on the Test Methods to Apply on Specifying the Physico-Chemical, Toxicological, and Eco-Toxicological Properties of the Substances and the Mixtures published in the Official Gazette dated 11/12/2013 and numbered 28848 (bis). Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex 11 are met.
(4) Ecotoxicological and toxicological tests shall be carried out in compliance with Bylaw on the Principles of Good Laboratory Practice, Harmonization of Test Units, Inspection of Good Laboratory Practice and Work published in the Official Gazette dated 9/3/2010 and numbered 27516.
(5) If a substance has already been registered, a new registrant shall be entitled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that the previous registrant(s) have given permission to refer to the full study reports for the purpose of registration. A new registrant shall not refer to such studies in order to provide the information required in Section 2 of Annex 6.
Chemical safety report and duty to apply and recommend risk reduction measures
ARTICLE 15 – (1) Without prejudice to the Article 6 of Bylaw on Safety and Security Measures related to Works with Chemical Substances published in the Official Gazette dated 12/08/2013 and numbered 28733, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tons or more per year per registrant. The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a mixture or in an article or a group of substances.
A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than the lowest of any of the following:
- The concentration threshold values that have been set Article 13 of Bylaw on Classification, Labelling and Packaging of Substances and Mixtures published in the Official Gazette dated 11/12/2013 and numbered 28848.
- 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex 13 of this Bylaw.
A chemical safety assessment of a substance shall include the following steps:
- Human health hazard assessment,
- Physicochemical hazard assessment,
- Environmental hazard assessment,
- Persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
(4) If, as a result of carrying out steps (a) to (ç) of paragraph 3, the registrant concludes that the substance fulfils the criteria of PBT or vPvB or any of the following hazard classes or categories set out in Annex 1 to the Bylaw on Classification, Labelling and Packaging of Substances and Mixtures, the substance includes chemical safety assessment exposure scenarios or exposure scenario assessment including specifying the exposure scenario categories and exposure scenario assumptions and the risk characterization. The exposure scenarios where appropriate the use and exposure categories, exposure assessment and risk characterisation shall address all identified uses of the registrant.
- Hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
- Hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
- Hazard class 4.1;
- Hazard class 5.1,
(5) The chemical safety report need not include consideration of the risks to human health from the following end uses:
- In food contact materials within the scope Bylaw on the Turkish Food Codex Substances and Materials in Contact with Food published in the Official Gazette dated 29/12/2011 and numbered 28157;
- In cosmetic products within the scope of Bylaw on Cosmetics.
(6) Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the Safety Data Sheets which he supplies in accordance with Article 27.
(7) Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.
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