TR-CLP (SEA)
BY-LAW ON THE CLASSIFICATION, LABELLING AND PACKAGING OF SUBSTANCES AND MIXTURES
Turkish CLP Regulation
The Turkish Ministry of Environment and Urbanization has issued revised Regulation on Classification, labeling and Packaging (CLP) of Dangerous Substances and Preparations in their Official Gazette with number 28848 on 11 December 2013. This regulation, also known as SEA regulation in Turkish, is aligned with EU CLP Regulation (1272/2008 EC) and fully enters into force on 1 June 2016.
The obligations of chemical manufacturers and importers for classification, labeling and notifications are:
01/June/2014 – 01/June/2015 – Notification to the Turkish C&L inventory starting 1 June 2014 and ending 1 June 2015 for substances placed on the market, either on their own or in a mixture before 1 June 2015. -Substances placed on the market after this date would have to be notified within one month
Since 01/June/2015- C&L notification of a hazardous substance placed on market shall be submitted within 1 month since a substance is placed on market.
Since 01/June/2016 – Hazardous substances and mixtures shall be classified and labelled according to Turkish CLP regulation only.
Obligations of Different Roles under Turkish CLP Regulation
Exemptions of Turkish CLP Regulation
- Medical products, veterinary medicinal products, cosmetic products, medical devices, and food or feeding stuff in finished states and intended for final user;
- Radioactive substances and mixtures;
- Non-isolated intermediates;
- Substances for research & development;
- Wastes;
Important Topics:
- Notifications will be done for all hazardous substances by not considering the annual import volumes even if it is imported 1 kg per year.
- Hazardous Polymers are in scope.
- Substances which are present a concentration above 0,1 % weight by weight (w/w) in those articles and which:
- are classified as carcinogenic, mutagenic or toxic to reproduction, category 1A,1B or category 2,or
- show persistent, bioaccumulative and toxic (PBT) properties, or
- very persistent and very bioaccumulative (vPvB) properties, or
- substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (b) or (c) — 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 points (a) to (c).
You can find the English Version of TR-CLP Regulation text as linked in here.
GHS Implementation in Turkey
Turkey has implemented GHS with different deadlines set for substances and mixtures. Chemical classification criteria, labelling and SDS requirements are mainly set by the following two regulations:
- Regulation on the Classification, Packaging and Labeling of Hazardous Materials and Products - Turkish CLP Regulation; and
- Regulation on the Preparation and Distribution of Safety Datasheet for Hazardous Materials and Products - Turkish SDS Regulation;
Critical Dates of Turkey GHS Implementation
- Substances : 1 June 2015
- Mixture : 1 June 2016
Classification
- Use of harmonized classification if possible;
- Propose harmonised classification when appropriate;
- Notify classification and labelling info to the Ministry of Environment and Urbanization(MoEU);
Labelling Requirements in Turkey
- Standard GHS label elements;
- Language: in Turkish
- Additional info: nominal quantity needs to be displayed on labels;
- Words such as "non-toxic or not harmful" are not allowed.
SDS Requirements in Turkey
- Standard 16-section SDSs;
- Must be prepared in Turkish and provided free of charge;
- Must be prepared by certified SDS experts in Turkey;
- A copy of SDSs shall be submitted to the Ministry of Environment and Urbanization (MoEU).
Information Disclosure on Labels and in SDSs
- Standard 16-section SDSs;
- Must be prepared in Turkish and provided free of charge;
- Must be prepared by certified SDS experts in Turkey;
- A copy of SDSs shall be submitted to the Ministry of Environment and Urbanization.
Our Turkish CLP Regulation Services
Our Turkish Chemical Regulation Services
- Only Representative Services
- Strategy and consulting services
- Assessment of your company’s regulatory obligations
- Preparation of data requirements and documentation for notification (including determination of physicochemical, toxicological, and eco-toxicological characteristics of substances if required)
- Submission of notifications in the format required
- Liaison with Turkish authorities where required
- Act as 'Turkish Representative’ on the behalf of non-Turkish operators
- Regulatory corporate training
*SEA : Abbreviation for TR-CLP in Turkish
TR-CLP (SEA) Notifications
01/June/2014 – 1/June/2015 – Notification to the Turkish C&L inventory starting 1 June 2014 and ending 1 June 2015 for substances placed on the market, either on their own or in a mixture before 1 June 2015. -Substances placed on the market after this date would have to be notified within one month
01/June/2015 – 1/June/2016 – Substances classification and labelling according to the new regulation is obligatory as of 1 June 2015 and for mixtures as of 1 June 2016; a two-year transition period for the products already on the market prior to this date will apply. – A unique point in the Turkish CLP (SEA) implementation as defined in article 41 of the regulation, is for the protection of CBI in that exporters to Turkey may address their importers C&L notification obligations through a Turkish appointed Legal Representative.
According to the Regulation;
ARTICLE 40– (1) Provisions related to the classification and labeling inventory included in the Article 41, 42 and 43 shall apply to:
- Substances specified in the first, second, third and fourth provisions of Annex 8,
- Substances within the scope of Article 2 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this By-Law or By-law on the Classification, Packaging and Labeling of Dangerous Substances and Preparations, where relevant, which results in the classification of the mixture as hazardous.
Agreed Entries ,
ARTICLE 42- Where the notification in Article 41(1) results in different entries on the inventory referred to in Article 43(1) for the same substance, the notifiers shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Competent Authority accordingly.
ARTICLE 43- (1) The Competent Authority, shall establish and maintain a classification and labeling inventory in the form of a database and provide its persistence.
(2) Information in the inventory which corresponds to the information referred to in Part 1 of Annex 10 may be publicly accessible.
Regulation full text as linked in here.
Obligation to Notify
ARTICLE 41-(1) Any manufacturer or importer, or group of manufacturers or importers, who places on the market a substance referred to in Article 40, shall submit the following information in order for it to be included in the inventory referred to in Article 43, in the format that exists on the Competent Authority web site:
- The following information about the notifier responsible for placing the substance on the market in self notification or each manufacturer or importer in joint submission;
- Name, address, telephone number, fax number and e-mail address;
- Contact person;
- Location of the production;
- substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (b) or (c) — 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 points (a) to (c).
- The identity of the substance as specified in point (a) of Article 39(1);
- The classification of the substance in accordance with Article 15;
- Where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;
- Specific concentration limits or M-factors, where applicable, in accordance with Article 12 of this By-Law together with a justification using the relevant Parts of Annex 11;
- The label elements specified in points (ç), (d) and (e) of Article 19(1) for the substance together with any supplemental hazard statements for the substance, determined in accordance with Article 27
Our Experienced Team
- Only Representative Services
- Strategy and consulting services
- Assessment of your company’s regulatory obligations
- Preparation of data requirements and documentation for notification (including determination of physicochemical, toxicological, and eco-toxicological characteristics of substances if required)
- Submission of notifications in the format required
- Liaison with Turkish authorities where required
- Act as 'Turkish Representative’ on the behalf of non-Turkish operators
- Regulatory corporate training
- Please contact for further information you need and/or for DorukSistem Only Representative Services for Turkey.
*SEA : Abbreviation for CLP in Turkish