TREACH (KKDIK) BY-LAW (Part 7, Section 1)
BY-LAW ON REGISTRATION, EVALUATION, AUTHORIZATION AND RESTRICTION OF CHEMICALS
SEVENTH PART
Authorization
FIRST SECTION
Authorization Requirement
Authorization and Substitution
ARTICLE 45 – (1) All manufacturers, importers and downstream users applying for authorizations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
General provisions
ARTICLE 46 – (1) A manufacturer, importer or downstream user shall not place a substance on the market for a use or use it himself if that substance is included in Annex 14, unless:
- The use(s) of that substance on its own or in a mixture or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorized in accordance with Articles 50, 51, 52, 53, 54 or ;
- The use(s) of that substance on its own or in a mixture or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorization requirement in Annex 14 itself in accordance with Article 48(2); or
- The date referred to in Article 48(1)(c)(1) has not been reached; or
- The date referred to in Article 48(1)(c)(1) has been reached and he made an application 18 months before that date but a decision on the application for authorization has not yet been taken; or
- In cases where the substance is placed on the market, authorization for that use has been granted to his immediate downstream user.
A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorization granted to an actor up his supply chain for that use.
Paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex 14 shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted.
Paragraphs 1 and 2 shall not apply to the following uses of substances:
- Uses in plant protection products within the scope of Bylaw on the Classification, Packaging and Labelling of Plant Protection Products;
- Uses in biocidal products within the scope of Bylaw on Biocidal Products;
- Use as motor fuels covered by Bylaw on Environmental Effects of Motor Fuels and Diesel Fuels Types; published in the Official Gazette dated 01/04/2017 and numbered 30025;
- Uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.
In the case of substances that are subject to authorization only because they meet the criteria in Article 47 (1) (a), (b) or (c) or because they are identified in accordance with Article 47 (1) (e) only because of hazards to human health, paragraphs 1 and 2 of this Article shall not apply to the following uses:
- Uses in cosmetic products within the scope of Bylaw on Cosmetics ;
- Uses in food contact materials within the scope of Bylaw on the Turkish Food Codex Substances and Materials in Contact with Food Paragraphs 1 and 2 shall not apply to the use of substances when they are present in mixtures:
- For substances referred to in Article 47 (1) (ç), (d) and (e), below a concentration limit of 0,1 % weight by weight (w/w);
- For all other substances, below the lowest of the concentration limits specified in Annex 6, Section 3 of Bylaw on Classification, Labelling and Packaging of Substances and Mixtures which result in the classification of the mixture as hazardous.
Substances to be included in Annex XIV
ARTICLE 47 – (1) The following substances defined as the substances of high concern may be included in Annex 14 in accordance with the procedure laid down in Article 48:
- Substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with title 3.6 of Annex 1 of Bylaw on Classification, Labelling and Packaging of Substances and Mixtures;
- Substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with title 3.5 of Annex 1 of the Bylaw on Classification, Labelling and Packaging of Substances and Mixtures ;
- Substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B in accordance with title 3.7 of Annex 1 to Bylaw on Classification, Labelling and Packaging of Substances and Mixtures;
- Substances which are persistent, bio accumulative and toxic in accordance with the criteria set out in Annex 13 of this Bylaw;
- Substances which are very persistent and very bio accumulative in accordance with the criteria set out in Annex 13 of this Bylaw;
- Substances — such as those having endocrine disrupting properties or those having persistent, bio accumulative and toxic properties or very persistent and very bio accumulative properties, which do not fulfill the criteria of subparagraphs (ç) or (d) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in this paragraph and which are identified on a case-by-case basis in accordance with the procedure set out in Article 49.
Inclusion of substances in Annex 14
ARTICLE 48 – (1) Whenever a decision is taken by the Ministry to include the substances referred to in Article 47 in Annex 14, such a decision shall specify for each substance:
- The identity of the substance as specified in Section 2 of Annex 6 ;
- The intrinsic property (properties) of the substance referred to in Article 47;
- Transitional arrangements:
- The date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorization is granted, the sunset date, which should take into account, where appropriate, the production cycle specified for that use;
- A date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorization is taken;
- Review periods for certain uses, if appropriate;
Uses or categories of uses exempted from the authorization requirement, if any, and conditions for such exemptions, if any.
Uses or categories of uses may be exempted from the authorization requirement provided that, on the basis of the existing specific related legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled. In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form.
Prior to a decision to include substances in Annex 14, the Ministry shall, determine priority substances to be included specifying for each substance the items set out in paragraph 1. Priority shall normally be given to substances with:
- PBT or vPvB properties; or
- Wide dispersive use; or
- High volumes.
The number of substances included in Annex 14 and the dates specified under paragraph 1 shall also take account of the Ministry’s capacity to handle applications in the time provided for.
Before the Ministry adopts a decision it shall make it publicly available on its website in accordance with Article 60 and 61, clearly indicating the date of publicationand all interested parties may submit comments within three months of the date of publication, in particular on uses which should be exempt from the authorization requirement. The Ministry shall make its decision according to the received comments. In the event that the substance proposed to be included in Annex 14 concerns the Relevant Authorities other than the Ministry, the Ministry shall first obtain the written opinion of such Relevant Authorities.
Subject to paragraph 6, after inclusion of a substance in Annex 14, this substance shall not be subjected to new restrictions under the procedure outlined in Part 8 covering the risks to human health or the environment from the use of the substance on its own, in a mixture or incorporation of a substance in an article arising from the intrinsic properties specified in Annex 14.
A substance listed in Annex 14 may be subjected to new restrictions under the procedure outlined in Part 8 covering the risks to human health or the environment from the presence of the substance in (an) article(s).
Substances for which all uses have been prohibited under Part 8 or by other relevant legislation shall not be included in Annex 14 or shall be removed from it.
Substances which as a result of new information no longer meet the criteria of Article 47 shall be removed from Annex 14 by the Ministry.
Defining the substances in Article 47
ARTICLE 49- (1) The procedure mentioned in this article is applied in order to define the substances compliant with the criteria mentioned in Article 47 and the substances to be included in Annex 14.
(2) Before starting the procedures for the substances in Article 47, the Ministry shall specify the substances in this Article in order to prepare dossier under Annex 15 and announce that the dossier is prepared under Annex 15 through website. The Ministry shall invite all releted parties to send their opinions to the Ministry.
(3) Any Relevant Authority prepares a dossier for the substances for which he thinks they are compliant with the criteria under Article 47 according to Annex 15 and send it to the Ministry. The Ministry shall forward the dossier to the relevant entities within 30 days after receivingif it is in accordance with Annex 15
(4) Beginning from the forward of the dossier within 60 days, all relevant entities will send their comments to the Ministry.
(5) After the 60 day period mentioned in paragraph 4, , the Ministry shall decide on adding or not the substance in paragraph 1 to the list.
(6)After the decision on adding the substance, the Ministry shall announce and update the list under paragraph 1 through website.
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