1 
 DRAFT BY -LAW ON THE CLASSIFICATION, LABELLING AND PACKAGING OF 
SUBSTANCES AND MIXTURES  
 
SECTION ONE  
AIM, SCOPE, BASIS AND DEFINITIONS  
 
Aim 
ARTICLE 1 – (1) The purpose of this By -Law is to ensure a high level of protection of 
human health and the environment as well as the free movement of substances, mixtures and 
some articles placed on the market by defining administrative and technical rules and 
principles for  classification of substances and mixtures, and the rules on labelling and 
packaging fo r hazardous substances and mixtures.  
Scope  
ARTICLE 2  – (1)   This By -law shall apply to ;  
a)  classification of substances and mixtur es placed on the market,  labelling and packaging of 
hazardous substances and mixtures;  
b)  manufacturers, importers and downstream users to classify substances and mixtures placed 
on the market;   
c) suppliers to label and package substances and mixtures placed on the market;  
ç) manufacturers, producers of articles and importers to classify tho se substances not placed 
on the market that are subject to Sections 1, 3, 4 and 5 of Annex 8 of this By -law, except 
substances that are included in the headings 1, 2 and 3 of the Annex 1 of The By -law on 
Inventory and Control of Chemicals, published in Off icial Gazzette no. 27092, dated 
26/12/2008.  
d) establishing a list of substances with their harmonised classifications and labelling 
elements in Part 3 of Annex 6;  
e) notification of classification and labelling of hazardous substances,  
f) establishing a classification and labelling inventory of substances, which is made up of all 
notifications, submissions and harmonised classifications and labelling elements referred to in 
points (d) and (e).  
(2) This By -law: 
a) shall not apply to the following substances and mixtures, which are in the finished state, 
intended for the final user:  
1)  Medicinal products in the scope of The By -law On Packaging and Labelling of Medicinal 
Products for Human Use published in Official Gazette no. 25904, dated 12/8/2005 . 
2) Products in the scope of The By -law On Veterinary Medicinal Products published in 
Official Gazette no. 28152, dated 24/12/2012 or in the scope of The By -law on Non -
medicinal Veterinary Health Products published in Official Gazette no 28145, dated 
17/12/2012.  
3) Products in the scope of “The By -law on Cosmetics” published in Official Gazette 
no25823, dated 23/05/2005.  
4) Products in the scope of The By -law on Invasive Active Medical Devices” published in 
Official Gazette no 24693 dated 12/03/2002.  
5) Pr oducts in the scope of By -law on Turkish Food Codex published in Official Gazette no 
28157 dated 29/12/2011.  
6) Products in the scope of By -law on Placing on The Market and Use of Animal Feeding 
Stuff published in the Official Gazette no. 28155 dated 27/12 /2011.  
b) shall not apply to:  
1) Substances and mixtures in scope of The By -law on Safe Transport of Radioactive 
Substance published in the Official Gazette no. 25869 dated 08/07/2005.  2 
 2) substances and mixtures which are subject to customs supervision, p rovided that they do 
not undergo any treatment or processing, and which are in temporary storage, or in a free zone 
or free warehouse with a view to re -exportation, or in transit;  
3) non -isolated intermediates;  
4) substances and mixtures for scientific res earch and development, provided they are used 
under controlled conditions in accordance with workplace and environmental legislation  in 
force in Türkiye.  
5) Waste defined in The By -law on General Principles of Waste Management published in the 
Official Gaz ette no. 26927 dated 05/07/2008.  
6) the transport of dangerous goods by air, sea, roa d, rail or inland waterways s ave where 
Article 3 5 applies ; 
7) Relevant institutions  may allow for exemptions from this By-law in specific cases for 
certain substances or m ixtures, where necessary in the interests of defence.  
Basis  
ARTICLE 3 – (1)This By -law is prepared on the ground of  
a) Environmental Law no.2872 dated 9/08/1983 and Decree Law on Organization and Duties 
of Ministry of Environment and Urbanization  no. 644 dated 4/7/2011, Decree Law on 
Establishment and Duties of the Ministry of Health and Affiliated Institutions, General 
Hygiene Law no. 1593 dated 24/04/1930 , Law on Establishment and Duties of Ministry of 
Labour and Social Security no. 3146 dated  9/01/198 5, Decree Law on Establishment and 
Duties of Ministry of Food, Agriculture and Livestock no. 639 dated 3/6/2011, Law on 
Veterinary Services, Plant Health, Food and Feed Stuff no.5996 dated 11/6/2010, Regulation 
on Procedures and principles for manufacture,  import, transport, conservation, storage, 
marketing, usage, disposal, inspection of unmonopolized explosive substances and hunting 
equipment and similar items which came into force by Cabinet Decree dated 14/8/1987 and 
numbered 87/12028 and Law on Prepara tion and Implementation of Technical Legislation 
Concerning Products no.4703 dated 29/6/2001.  
b) This By -law is prepared in parallel with the provisions of Regulation (E C) No 1272/2008 
of The European Parliament and of the Council  of 16 December 2008  on cl assification, 
labelling and packa ging of substances and mixtures.  
Definitions  
ARTICLE 4 – For the purpose of this Regulation, the following definitions shall apply:  
a) ‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two  
or more elements so combined that they cannot be readily separated by mechanical means; 
alloys are considered to be mixtures for the purposes of this By -law, 
b) ‘downstream user’ means any natural or legal person established in Türkiye , other than the 
manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the 
course of his industrial or professional activities. A distributor or a consumer is not a 
downstream user.  
c) ‘package’ means the complete product of the packing op eration, consisting of the 
packaging and its contents;  
ç) ‘packaging’ means one or more receptacles and any other components or materials 
necessary for the receptacles to perform their containm ent and other safety functions;  
d) ‘intermediate packaging’ means packaging placed between inner packaging, or articles, and 
outer packaging.   
e) ‘intermediate’ means a substance that is manufactured for and consumed in or used for 
chemical processing in order to be transformed into another substance;  
f) ‘notifier’  means the manufacturer or the importer, or group of manufacturers or importers 
notifying to the Competent Authority ; 3 
 g) ‘scientific research and development’ means any scientific experimentation, analysis or 
chemical research carried out under controlled conditions;  
ğ) CAS Number means the number give n by Chemicals Abstract Service;  
h) ‘distributor’ means any natural or legal person established within Türkiye , including a 
retailer, who only stores and places on the market a substance, on its own or in a mi xture, for 
third parties;  
ı) EINECS means the European Inventory of Existing Commercial Substances. This inventory 
contains the definitive list of all substances deemed to be on the Community market on 18 
September 1981;  
i) ELINCS means the European List o f Notified Chemicals Substances. It designate all new 
substances placed on the Community market as from 1 8 September 1981, which has been 
allocated an ELINCS number after their notification to the European Commission;  
j) ‘cut-off value’ means a threshold o f any classified impurity, additive or individual 
constituent in a substance or in a mixture, above which threshold these shall be taken into 
account for determining if the substance or the mixture, respectively, shall be classified;  
k) ‘article’ means an object which during production is given a special shape, surface or 
design which determines its function to a greater degree than does its chemical composition;  
l) ‘producer of an article’ means any natural or legal person who makes or assembles an 
article  within Türkiye ; 
m) ‘differentiation’ means distinction within hazard classes depending on the route of 
exposure or the nature of the effects;  
n) IUPAC name means the name given to the substance by ‘International Union of Pure and 
Applied Chemistry’.  
o) ‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally 
removed (except for sampling) from the equipment in which the synthesis takes place  
ö) ‘Related institutions’ means Ministry of Health for biocidal products, deterge nts, air 
aromatizer products, cleaning products containing strong acids or bases and supplementary 
chemicals in pool cleaning, Ministry of Food, Agriculture and Livestock for plant protection 
products, Ministry of Science, Industry and Technology and Minis try for Internal Affairs for 
regulations concerning explosives and pyrotechnic substances and Ministry of Environment 
and Urbanization for all other hazardous chemicals and mixtures and for the coordination of 
studies which will be performed within the fra me of this By-law. 
p) ‘manufacturing’ means production or extraction of substances in the natural state;  
r) ‘manufacturer’ means any natural or legal person established within Türkiye  who 
manufactures a substance within Türkiye ; 
s) ‘import’ means the physical introduction i nto the customs territory of Türkiye;  
ş) ‘importer’ means any natural or legal person established within Türkiye  who is responsible 
for import;  
t) ‘concentration limit’ means a threshold of any classified impurity, additive or indivi dual 
constituent in a substance or in a mixture that may trigger classification of the substance or 
the mixture, respectively;  
u) ‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling 
into containers, transfer from one container to another, mixing, production of an article or any 
other utilisation;  
ü) ‘mixture’ means a mixture or solution composed of two or more substances;  
v) ‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance 
classi fied as hazardous to the aquatic environment acute category 1 or chronic category 1, and 
is used to derive by the summation method the classification of a mixture in which the 
substance is present;  4 
 y) ‘substance’ means a chemical element and its compounds in the natural state or obtained by 
any manufacturing process, including any additive necessary to preserve its stability and any 
impurity deriving from the process used, but excluding any solvent which may be separated 
without affecting the stability of t he substance or changing its composition;  
z) ‘monomer’ means a substance which is capable of forming covalent bonds with a sequence 
of additional like or unlike molecules under the conditions of the relevant polymer -forming 
reaction used for the particular  process;  
aa) ‘precautionary statement’ means a phrase that describes recommended measure(s) to 
minimise or prevent adverse effects resulting from exposure to a hazardous substance or 
mixture due to its use or disposal;  
bb) ‘placing on the market’ means su pplying or making available, whether in return for 
payment or f ree of charge, to a third party , or import;  
cc) ‘polymer’ means a substance consisting of molecules characterised by the sequence of one 
or more types of monomer units. Such molecules must be d istributed over a range of 
molecular weights wherein differences in the molecular weight are primarily attributable to 
differences in the number of monomer units. A polymer comprises the following:  
1) a simple weight majority of molecules containing at lea st three monomer units which are 
covalently bound to at least one other monomer unit or other reactant;  
2) less than a simple weight majority of molecules of the same molecular weight.  
çç) SMILES means Simplified Molecular Input Line Entry to represent che mical structure in 
linear showing form . 
dd) ‘supplier’ means any manufacturer, importer, downstream user or distributor placing on 
the market a substance, on its own or in a mixture, or a mixture;  
ee) ‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous 
Goods;  
ff) ‘signal word’ means a word that indicates the relative level of severity of hazards to alert 
the reader to a potential hazard; the following two levels are distinguished:  
(a) ‘Danger’ means a signal word indicating the  more severe hazard categories;  
(b) ‘Warning’ means a signal word indicating the less severe hazard categories;  
gg) Competent Authority means Ministry of Environment and Urbanization;  
ğğ) ‘hazard statement’ means a phrase assigned to a hazard class and cat egory that describes 
the nature of the hazards of a hazardous substance or mixture, including, where appropriate, 
the degree of hazard;  
hh) ‘hazard pictogram’ means a graphical composition that includes a symbol plus other 
graphic elements, such as a borde r, background pattern or colour that is intended to convey 
specific information on the hazard concerned;  
ıı) ‘hazard category’ means the division of criteria within each hazard class, specifying hazard 
severity;  
ii) ‘hazard class’ means the nature of the p hysical,  health or environmental hazard.  
 
SECTION TWO  
GENERAL PROVISIONS ON CLASSIFICATION, LABELLING AND PACKAGING 
OF HAZARDOUS SUBSTANCES AND MIXTURES  
 
Classification  of Substances and Mixtures  
ARTICLE 5 - (1) The following principles apply for specification of the hazard classes and 
classifying dangerous substances and mixtures:  
a) A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards 
or environmental hazards, laid down in Parts 2 to 5 of Annex 1 is hazardous and shall be 
classified in relation to the respective hazard classes provided for in t hat Annex.  5 
 b) Where, in Annex 1, hazard classes are differentiated on the basis of the route of exposure 
or the nature of the effects, the substance or mixture shall be classified in accordance with 
such differentiation.  
General Principles of Classificatio n, Labelling and Packaging of Hazardous Substances 
and Mixtures  
ARTICLE 6 – (1) The principles of classification, labelling and packaging provisions of this 
By-law are as follows:  
a)  Manufacturers, impor ters and downstream users shall classify substances or mixtures in 
accordance with Section Three before  placing them on the market.  
b) Without prejudice to the requirements of paragraph 1  (a), manufacturers, producers of 
articles and importers shall classify  those substances not placed on the market in acco rdance 
with Section Three.  
c) If a substance is subject to harmonised classification and  labelling in accordance with 
Section Six through an entry in Part 3 of  Annex 6, that substance shall be classified in 
accordance with  that entry, and a classification of that substance in accordance  with Section 
Three  shall not be performed for the hazard classes or  differentiations covered by that entry.  
However, where the substance also falls within one or more   hazard classes or differentiations 
not covered by an ent ry in  Part 3 of Annex 6, classification under Section Three  shall be 
carried  out for those hazard classes or differentiations.  
ç) Where a substance or mixture is classified as hazardous,  suppliers shall ensure that the 
substance or mixture is labelled  and packaged in accordance with Sections Four and Five , 
before placing  it on the market.  
d) In fulfilling their responsibilities under paragraph (1)(ç) , distributors  may use the 
classification for a substance or mixture  derived in accordance with Section Three  by an actor 
in the supply  chain.  
e) In fulfilling their responsibilities under paragraphs (1)(a) and (1)(c), downstream users may 
use the classification of a substance or  mixture derived in accordance with Section Three by 
an actor in the  supply chain, pr ovided that they do not change the composition  of the 
substance or mixture.  
f) A mixture referred to in Part 2 of Annex 2 that contains any  substance classified as 
hazardous shall not be placed on the  market, unless it is labelled in accordance with Section 
Four.  
g) For the purposes of this By-law, the articles referred to  in section 2.1 of Annex 1 shall be 
classified, labelled and  packaged in accordance with the rules for substances and  mixtures 
before being placed on the market.  
ğ) Suppliers in a s upply chain shall cooperate to meet the  requirements for classification, 
labelling and packaging in this  By-law. 
h) Substances and mixtures shall not be placed on the market  unless they comply with this 
Regulation.  
ı) Placing on the market  of substances an d mixtures  which are classified, labelled and 
packaged according to the provisions of this By -law cannot be prohibited, restricted or 
impeded.  
 
SECTION  THREE  
HAZARD CLASSIFICATION  
 
Identification and examination of available information on  substances  
ARTICLE 7 -(1) Manufacturers, importers and downstream users of a  substance shall identify 
the relevant available information for  the purposes of determining whether the substance 6 
 entails a  physical, health or environmental hazard as set out in Annex 1, and, in particular, the 
following:  
(a) data generated in accordance with any of the methods  referred to in Article 10(3); 
(b) epidemiological data and experience on the effects on  humans, such as occupational data 
and data from accident  databases;  
(c) any other information generated in accordance with  Annex 9 to this By -law; 
(ç) any new scientific information;  
(d) any other information generated under internationally  recognised chemical programmes.  
(2) Manufacturers, importers and downstream users shall  examine the information referred to 
in paragraph 1 to ascertain  whether it is adequate, reliable and scientifically valid for the  
purpose of the evaluation pursuant to Articles (11) to (18) . 
Identification and examination of available information on  mixtures  
ARTICLE 8 -(1) Manufacturers, importers and downstream users of a  mixture shall identify 
the relevant available information on the  mixture itself or the substances contained in it for the 
purposes  of determining whether the mixture entails a physical, health or  environmental 
hazard as set out in Annex 1, and, in particular,  the following:  
(a) data generated in accordance with any of the methods  referred to in Article 10(3) on the 
mixture itself or the  substances contained in it;  
(b) epidemiological data  and experience on the effects on  humans, such as occupational data 
and data from accident  databases;  
(c) any other information generated in accordance with Annex 9 to this By -law f or the 
mixture itself or the substances contained in it;  
(ç) any new scient ific information;  
(d) any other information on the mixture itself or the  substances contained in it  generated 
under internationally  recognised chemical programmes.  
(2) Subject to paragraphs 3 and 4, where the information  referred to in paragraph 1 is 
available for the mixture itself, and  the manufacturer, importer or downstream user has 
ascertained  that information to be adequate and reliable and where  applicable, scientifically 
valid, that manufacturer, importer or  downstream user shall use that infor mation for the 
purposes of  the evaluation pursuant to Section Three.  
(3) For the evaluation of mixtures pursuant to Articles (11) to (18)  in relation to the ‘germ cell 
mutagenicity’, ‘carcinogenicity’  and ‘reproductive toxicity’ hazard classes referred to in 
sections 3.5.3.1, 3.6.3.1 and 3.7.3.1 of Annex 1, the manufacturer,  importer or downstream 
user shall only use the relevant  available information referred to in paragraph 1 for the  
substances in the mixture.  Further, in cases where the available test da ta on the mixture  itself 
demonstrate germ cell mutagenic, carcinogenic or toxic to  reproduction effects which ha ve 
not been identified from the information on the individual substances, those data shall also be  
taken into account.  
(4) For the evaluation of  mixtures pursuant to Articles (11) to (18)  in relation to the 
‘biodegradation and bioaccumulation’  properties within the ‘hazardous to the aquatic 
environment’  hazard class referred to in sections 4.1.2.8 and 4.1.2.9 of  Annex 1, the 
manufacturer, importer  or downstream user shall  only use the relevant available information 
referred to in  paragraph 1 for the substances in the mixture.  
(5) Where no or inadequate test data on the mixture itself of the  kind referred to in paragraph 
1 are available, the manufacturer,  importer or downstream user shall use other available  
information on individual substances and similar tested mixtures  which may also be 
considered relevant for the purposes of  determining whether the mixture is hazardous, 
provided that  that manufacturer, importer or downstream user has ascertained  that information 
to be adequate and reliable for the purpose of  the evaluation pursuant to Article 11(4). 
 7 
 Animal and human testing  
ARTICLE 9 - (1) Where new tests are carried out for the purposes of this  By-law, tests on 
animals within the meaning of By-law on Protection of Test Animals Used in Experimental 
and Other Scientific Purposes published in Official Gazette no.25464 and dated 16/5/2004  
and The By -law on Procedures and Principles of Establi shing, Operating and Inspection of 
Laboratories which generates Testing Animal Livestock or which perform tests on Animals 
shall be undertaken only where no other alternatives,  which provide adequate reliability and 
quality of data, are  possible.  
(2) Tests  on non -human primates shall be prohibited for the  purposes of this By-law. 
(3) Tests on humans shall not be performed for the purposes of  this By-law. Data obtained 
from other sources, such as  clinical studies, can however be used for the purposes of this  By-
law. 
Generating new information for substances and mixtures  
ARTICLE 10 - (1) For the purposes of determining whether a substance or a  mixture entails 
a health or environmental hazard as set out in  Annex 1 to this Regulation, the manufacturer, 
importer or downstream user may, provided that he has exhausted all other  means of 
generating information including by applying the rules  provided for in Annex 9 of this By -law 
perform new tests.  
(2) For the purposes of determining whether a substance or a  mixture entails any of the 
physical hazards referred to in Part 2  of Annex 1, the manufacturer, importer or downstream 
user shall  perform the tests required in that Part, unless there is adequate  and reliable 
information already available.  
(3) The tests referred t o in paragraph 1 shall be conducted in  accordance with one of the 
following methods:  
(a) the test methods referred to in  
or 
(b) sound scientific principles that are internationally recognised  or methods validated 
according to international  procedures.  
(4) Where the manufacturer, importer or downstream user  carries out new ecotoxicological or 
toxicological tests and  analyses, these shall be carried out in compliance with The By -law on 
Principles of Good Laboratory Practices and Certification of Testing Labo ratories published 
in Official Gazette no. 24796 and dated 25/6/2002.  
(5) Where new tests for physical hazards are carried out for the  purposes of this By-law, they 
shall be carried out, at the latest  from 1 January 201 5, in laboratories which is certifica ted in 
compliance with The By -law on Principles of Good Laboratory Practices and Certification of 
Testing Laboratories  or by laboratories complying with a relevant  internationally recognised 
standard.  
(6) Tests that are carried out for  the purposes of this  By-law shall be carried out on the 
substance or on the mixture in the  form(s) or physical state(s) in which the substance or 
mixture is  placed on the market and in which it can reasonably be expected  to be used.  
Evaluation of       hazard  information for substances and  mixtures  
ARTICLE 11 - (1) Manufacturers, importers and downstream users of a  substance or a 
mixture shall evaluate the information identified  in accordance with Articles 7 to 10 by 
applying to it the  criteria for classificat ion for each hazard class or differentiation in  Parts 2 to 
5 of Annex 1, so as to ascertain the hazards associated  with the substance or mixture.  
(2) In evaluating available test data for a substance or a mixture  which have been obtained 
from test methods other than those  referred to in Article 10( 3), manufacturers, importers and  
downstream users shall compare the test methods employed  with those indicated in that 
Article in order to determine  whether the use of those test methods affects the evaluation  
referred to in paragraph 1 of this Article.  8 
 (3) Where the criteria cannot be applied directly to available  identified information, 
manufacturers, importers and downstream  users shall carry out an evaluation by applying a 
weight of  evidence determination using  expert judgement in accordance  with section 1.1.1 of  
Annex 1 to this By-law, weighing all  available information having a bearing on the 
determination of  the hazards of the substance or the mixture, and in accordance  with Annex 9.  
(4) Where only the info rmation referred to in Article 8(5) is  available, manufacturers, 
importers and downstream users shall  apply the bridging principles referred to in section 1.1.3 
and in  each section of Parts 3 and 4 of Annex 1 for the purposes of the  evaluation.  However, 
where that information permits the application neither  of the bridging principles nor the 
principles for using expert  judgement and weight of evidence determination as described in  
Part 1 of Annex 1, manufacturers, importers and downstream  users shall evalua te the 
information by applying the other  method or methods described in each section of Parts 3 and 
4 of Annex 1. 
(5) When evaluating the available information for the purposes of classification, the 
manufacturers, importers and downstream users shall cons ider the forms or physical states in 
which the substance or mixture is placed on the market and in which it can reasonably be 
expected to be used.  
Concentration limits and M -factors for classification of substances and mixtures  
ARTICLE 12 - (1) Specific concentration limits and generic concentration limits are limits 
assigned to a substance indicating a threshold at or above which the presence of that substance 
in another substance or in a mixture as an identified impurity, additive or individual 
constitu ent leads to the classification of the substance or mixture as hazardous.  
Specific concentration limits shall be set by the manufacturer, importer or downstream user 
where adequate and reliable scientific information shows that the hazard of a substance is  
evident when the substance is present at a level below the concentrations set for any hazard 
class in Part 2 of Annex 1 or below the generic concentration limits set for any hazard class in 
Parts 3, 4 and 5 of Annex 1. 
In exceptional circumstances specifi c concentration limits may be set by the manufacturer, 
importer or downstream user where he has adequate, reliable and conclusive scientific 
information that a hazard of a substance classified as hazardous is not evident at a level above 
the concentrations  set for the relevant hazard class in Part 2 of Annex 1 or above the generic 
concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.  
(2) M-factors for substances classified as hazardous to the aquatic environment, acute 
category 1 or chronic category 1, shall be established by manufacturers, importers and 
downstream users.  
(3) Notwithstanding paragraph 1, specific concentration limits shall not be set for harmonised 
hazard classes or differentiations for substances included  in Part 3 of Annex 6. 
(4) Notwithstanding paragraph 2, M -factors shall not be set for harmonised hazard classes or 
differentiations for substances included in Part 3 of Annex 6 for which an M -factor is given in 
that Part.  
However, where an M -factor is not given in Part 3 of Annex 6 for substances classified as 
hazardous to the aquatic environment, acute category 1 or chronic category 1, an M -factor 
based on available data for the substance shall be set by the manufacturer, importer or 
downstream user. When a mixture including the substance is classified by the manufacturer, 
importer or downstream user using the summation method, this M -factor shall be used.  
(5) In setting the specific concentration limit or M -factor manufact urers, importers and 
downstream users shall take into account any specific concentration limits or M -factors for 
that substance which have been included in the classification and labelling inventory.  
(6) Specific concentration limits set in accordance with  paragraph 1 shall take precedence 
over the concentrations in the relevant sections of Part 2 of Annex 1 or the generic 9 
 concentration limits for classification in the relevant sections of Parts 2, 3, 4 and 5 of Annex 
1. 
Cut-off values  
ARTICLE 13 - (1) Where a substance contains another substance, itself classified as 
hazardous, whether in the form of an identified impurity, additive or individual constituent, 
this shall be taken into account for the purposes of classification, if the concentration of t he 
identified impurity, additive or individual constituent is equal to, or greater than, the 
applicable cut - off value in accordance with section 1.1.2.2 of Annex 1. 
2. Where a mixture contains a substance classified as hazardous, whether as a component or  
in the form of an identified impurity or additive, this information shall be taken into account 
for the purposes of classification, if the concentration of that substance is equal to or greater 
than its cut -off value in accordance with section 1.1.2.2 of Annex 1. 
Specific cases requiring further evaluation  
ARTICLE 14  – (1) Where, as a result of the evaluation carried out pursuant to Article 11, the 
following properties or effects are identified, manufacturers, importers and downstream users 
shall take them  into account for the purposes of classification:  
(a) adequate and reliable information demonstrates that in practice the physical hazards of a 
substance or a mixture differ from those shown by tests;  
(b) conclusive scientific experimental data show that t he substance or mixture is not 
biologically available and those data have been ascertained to be adequate and reliable;  
(c) adequate and reliable scientific information demonstrates the potential occurrence of 
synergistic or antagonistic effects among the substances in a mixture for which the evaluation 
was decided on the basis of the information for the substances in the mixture.  
Decision To Classify Substances And Mixtures  
ARTICLE 1 5- (1) If the evaluation undertaken pursuant to Article 11 and Article 1 4 shows 
that the hazards associated with the substance or mixture meet the criteria for classification in 
one or more hazard classes or differentiations in Parts 2 to 5 of Annex 1, manufacturers, 
importers and downstream users shall classify the substance or  mixture in relation to the 
relevant hazard class or classes or differentiations in accordance with subparagraphs (a) and 
(b) of paragraph.  
a) one or more hazard categories for each relevant hazard class or differentiation;  
b) subject to Article 2 3, one or  more hazard statements corresponding to each hazard category 
assigned in accordance with (a).  
Specific Rules For The Classification Of Mixtures  
ARTICLE 16 - (1) The classification of a mixture shall not be affected where the evaluation 
of the information i ndicates any of the following:  
a) that the substances in the mixture react slowly with atmospheric gases, in particular 
oxygen, carbon dioxide, water vapour, to form different substances at low concentration;  
b) that the substances in the mixture react ver y slowly with other substances in the mixture to 
form different substances at low concentration;  
c) that the substances in the mixture may self -polymerise to form oligomers or polymers, at 
low concentration.  
(2) A mixture need not be classified for explosi ve, oxidising, or flammable properties as 
referred to in Part 2 of Annex 1 provided that any of the following requirements are met:  
(a) none of the substances in the mixture possesses any of those properties and, on the basis of 
the information available t o the supplier, the mixture is unlikely to present hazards of this 
kind;  
(b) in the event of a change in the composition of a mixture, scientific evidence indicates that 
an evaluation of the information on the mixture will not lead to a change in classific ation;  10 
 (c) where a mixture is placed on the market in the form of an aerosol dispenser, it satisfies the 
provisions of the By -law on Aerosol Containers published in Official Gazette no.24246 and 
dated 30/11/2000.  
Review of classification for substances and  mixtures  
ARTICLE 17 - (1) Manufacturers, importers and downstream users shall take all reasonable 
steps available to them to make themselves aware of new scientific or technical information 
that may affect the classification of the substances or mi xtures t hey place on the market and 
carry out a new evaluation in accordance with this Section . 
(2) Where the manufacturer, importer or downstream user introduces a change to a mixture 
that has been classified as hazardous, that manufacturer, importer or downstream user shall 
carry out a new evaluation in accordance with this Section  where the change is either of the 
following:  
(a) a change in the composition of the initial concentration of one or more of the hazardous 
constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex 1; 
(b) a change in the composition involving the sub stitution or addition of one or more 
constituents in concentrations at or above the cut -off value referred to in Article 13. 
(3) A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there is 
valid scientific justification that th is will not result in a change of classification.  
(4) Manufacturers, importers and downstream users shall adapt the classification of the 
substance or the mixture in accordance with the results of the new evaluation except where 
there are harmonised hazard  classes or differentiations for substances included in Part 3 of 
Annex 6. 
(5) For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is within 
the scope of By -law  on Classification, Packaging and Labelling of Plant Protection Prod ucts 
published in Official Gazette no. 27885, dated 25/03/2011 and By -law on Biocidal Products 
published in Official Gazette 274449 (4th replica) dated 31/12/2009, , the requirements of 
those By -laws shall also apply.  
Classification of substances included in the classification and labelling inventory  
ARTICLE 1 8- (1) Manufacturers and importers may classify a substance differently from the 
classification already included in the classification and labelling inventory, provided they 
submit the reasons for the classification to the Competent Authority together with the 
notificati on in accordance with Article 42 . 
(2) Paragraph 1 shall not apply if the classification included in the classification and labelling 
inventory is a harmonised classification included in Part 3 of Annex 6. 
 
SECTION FOUR  
HAZARD COMMUNICATION IN THE FORM OF LABELLING  
 
Content of the label  
ARTICL E 19 – (1) A substance or mixture classified as hazardous and contained in 
packaging shall bear a label including the following elements:  
(a) the name, address and telephone number of the supplier(s);  
(b) the nominal quantity of the substance or mixture in  the package made available to the 
general public, unless this quantity is specified elsewhere on the package;  
(c) product ident ifiers as specified in Article 20 ; 
(ç) where applicable, hazard pictogr ams in accordance with Article 21 ; 
(d) where applicable, signal wor ds in accordance with Article 22 ; 
(e) where applicable, hazard statemen ts in accordance with Article 23 ; 
(f) where applicable, the appropriate precautionary statemen ts in accordance with Article 24 ; 
(g) where applicable, a section for supplemental information in accordance with Article 2 7. 11 
 2. Th e label shall be written in Turkish where the substance or mixture is placed on the 
market  in Turkey . Suppliers may use more languages on their labels than Turkish , provided 
that the same details  appear in all languages used.  
Product identifiers  
ARTICLE 20 -(1) The label shall include details permitting the identification of the substance 
or mixture (hereinafter referred to as ‘product identifiers’).  The term used for identification of 
the substance or mixture shall be the same as that used in the safety data sheet drawn up in 
accordance with By-law on Compilation and Distribution of  Safety Data Sheet s of Dangerous 
Substances and Preparations publishe d in Official Gazette no.27092, dated 26/12/2008 , 
without prejudice to Article 1 9(2) of this By-law. 
2. The product identifier for a substance shall consist of at least the following:  
(a) if the substance is included in Part 3 of Annex 6, a name and EC and /or CAS  number as 
given therein;  
(b) if the substance is not included in Part 3 of Annex 6, but appears in the classification and 
labelling inventory, a name and EC and/or CAS  number as given therein;  
(c) if the substance is not included in Part 3 of Annex 6 nor in the classification and labelling 
inventory, the number provided by the CAS number , together with the name set out in the 
nomenclature provided by the , or the CAS number together with another int ernational 
chemical name(s); or  
(ç) if the CAS number is not available, the name set out in the IUPAC Nomenclature or 
another international chemical name(s).  Where the name in the IUPAC nomenclature exceeds 
100 characters, one of the other names (usual nam e, trade name, abbreviation) may be used 
provided that the notification in accordance with Article 4 2 includes both the name set out in 
the IUPAC Nomenclature and the other name used.  
(3) The product identifier for a mixture shall consist of both of the fo llowing:  
(a) the trade name or the designation of the mixture;  
(b) the identity of all substances in the mixture that contribute to the classification of the 
mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell 
mutagenicity, c arcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific 
target organ toxicity or aspiration hazard.  
(4) Where, in the case referred to in paragraph (3) (b), that requirement leads to the provision 
of multiple chemical names, a max imum of four chemical names shall suffice, unless more 
than four names are needed to reflect the nature and the severity of the hazards.  In the latter 
case, more than four chemical names may be used.  
Hazard pictograms  
ARTICLE 21-(1) The label shall include  the relevant hazard pictogram(s), intended to 
convey specific information on the hazard concerned.  
(2) Subject to Article 3 5, hazard pictograms shall fulfil the requirements laid down in section 
1.2.1 of Annex 1 and in Annex 5. 
(3) The hazard pictogram relevant for each specific classification is set out in the tables 
indicating the label elements required for each hazard class in Annex 1. 
Signal words  
ARTICLE 22 -(1) The label shall include the relevant signal word in accordance wit h the 
classification of the hazardous substance or mixture.  
(2) The signal word relevant for each specific classification is set out in the tables indicating 
the label elements required for each hazard class in Parts 2 to 5 of Annex 1. 
(3) Where the signal  word ‘Danger’ is used on the label, the signal word ‘Warning’ shall not 
appear on the label.  
 
 12 
 Hazard statements  
ARTICLE 23 -(1) The label shall include the relevant hazard statements in accordance with 
the classification of the hazardous substance or mixt ure. 
(2) The hazard statements relevant for each classification are set out in the tables indicating 
the label elements required for each hazard class in Parts 2 to 5 of Annex 1. 
(3) Where a substance is included in Part 3 of Annex 6, the hazard statement relevant for each 
specific classification covered by the entry in that Part shall be used on the label, together  
with the hazard statements referred to in paragraph 2 for any other classification not covered 
by that entry.  
(4) The hazard statements shall be worded in accordance with Annex 3. 
Precautionary statements  
ARTICLE 2 4-(1) The label shall include the relevant precautionary statements.  
(2) The precautionary statements shall be selected from those set out in the tables in  Parts 2 to 
5 of Annex 1 indicating the label elements for each hazard class.  
(3) The precautionary statements shall be selected in accordance with the criteria laid down in 
Part 1 of Annex 4 taking into account the hazard statements and the intended or id entified use 
or uses of the substance or the mixture.  
(4) The precautionary statements shall be worded in accordance with Part 2 of Annex 4. 
Derogations from Labelling Requirements for Special Cases  
ARTICLE  25-(1)  The specific provisions on labell ing laid down in section 1.3 of Annex 1 
shall apply in respect of the following:  
a)Transportable gas cylinders;  
b) Gas containers intended f or propane, butane or liquefied petroleum gas;  
c) Aerosols and containers fitted with a s ealed spray attachment and containing substances or  
mixtures classified as  presenting an aspiration hazard;  
ç) Metals in massive form, alloys, mixtures containing  polymers, m ixtures containing  
elastomers;  
d) Explosives, as referred to in section 2.1 of Annex 1, placed  on the market with a view to  
obtaining an explosive or  pyrotechnic effect.  
Request for Use of an Alternative Chemical Name 
ARTICLE  26-(1) The manufacturer, i mporter or downstream user of a substance or a 
mixture may submit a request to the Relevant Institution to use an alternative chemical name  
which refers to that substance either by means of a name that identifies the most important 
functional ch emical groups or by means of an alternative designation, where the s ubstance 
meets the criteri a set out in Part 1 of Annex 1 and where he can demonstrate that disclosure 
on the label or in the sa fety data sheet of the chemical identity of that substance puts  the 
confidential nature of his business, in particular his intellectual property rights, at  risk. 
(2) Any request referred to in pa ragraph 1 of this Article shall be made to the Relevant 
Institution  in the format exists in the web page  of the Competent Authority . 
(3) The Relevant Institution  may requi re further information from the manufacturer,  importer 
or dow nstream user making the request if such information is necessary to  take a decision. If 
the Relevant Institution raises no objection within six week s of the request or the receipt of 
further required information , the use of the requested na me shall be deemed to be allowed.  
(4) If the Relevant Institution  does not accept the request,  manufacturer, importer or 
downstrea m user may waive an objection  to the Competent Authority.  
(5) The Relevant Institution  shall inform  Competent Authority about the outcome of the 
request in accor dance with paragraph 3 or 4 and provide Competent Authority  with the 
information  submitted by the manufacturer, importer or downstream user.  
(6) Where new in formation sho ws that an alternative chemical name used does not provide 
sufficient information for necessary health and safety precautions to be taken at the workplace 13 
 and to  ensure that risks from handling the mixture can be controlled,  the Relevant Institution  
shall review  its decision  on the use of that alternative chemical name. The Relevant Institution  
may withdraw its decision or amend it by a decision specifying whi ch alternative chemical 
name is allowed to be used. If the  Relevant Institution w ithdraws or amends its decision, it 
informs the Competent Authority together with its justifications within four weeks of the 
withdrawing or amendment . 
(7) Where the use of an alternative chemical name has been  allowed, but the classification of  
the substa nce in a mixture for which the alternative name is us ed no longer meets the criteria 
set out in section 1.4.1 of Annex 1, the supplier of that substance in a mixture shall use the 
product identifier for the substance in accordance with Article 20 on the la bel and in the 
safety data sheet, and not the alternative chemical name.  
(8) The manuf acturer, importer or downstream user may use the alternative name, accepted as 
valid by the Relevant Institution,  on the label and in the safety data sheet  for six years.  The 
information concerning the substances in mixtures or in articles  can be publicly available, free 
of charge, in accordance with Annex 10 Part 1 and Part 2 by Relevant Institution.  
(9) Where the supplier of a mixture, before 01/06/2016 , has demonstrated under Article 37 of 
By-Law on the Classification, Packaging and Labelling of Dangerous Substan ces and 
Preparations published in the Official Gazette dated 26/12/2008 and numbered 27092,  that the 
disclosure of the chemical ident ity of a sub stance in a mixture puts the confidential nature of 
his business at risk, he can continue to use the agreed alter native name for the purposes of this 
By-Law.  
(10)Manufacturer, importer or downstream user pay fee  which is  published in the website of 
the Competent Authority , to Relevant Institution  for the alternative name presented in 
accordance with Article 26 (1) and 26(2) . 
Supplemental information on the label  
ARTICLE  27-(1)  Following provisions shall be applied for supplemental information on 
label:  
a) Statements shall be included in the section for supplemental  information on the label where 
a substance or mixture classified  as hazardous has the physical properties or health properties  
referred to in sections 1.1 and 1.2 of Annex 2 and Part 2 of Annex 3 . 
b) Where a substance is included in Part 3 of Annex 6, any  supplemental hazard statements 
given therein for the substance  shall be included in the supplemental information on the label.  
(2) A statement shall be included in the section for supplemental  information on the label 
where a substance or mixture  classified as hazardous falls within the scope of By-Law on the 
Classification, Packaging and Labelling of Plant Protection Products  published in the Official 
Gazette dat ed 25/03/2011 and numbered 27885 . The statement shall be worded in accordance 
with Part 4 of  Annex 2 and Part 3 of Annex 3 to this By -Law.  
(3) The supplier may include supplemental information in the  section for supplemental 
information on the label other than  that referred to in paragraphs 1 and 2, provided that that  
information does not make it more difficult to identify the label  elements referred to in Article 
19(1) (a) to ( f) and that it provides  further details and does not contradict or cast doubt on the  
validity of the info rmation specified by those elements.  
(4)Statements such as ‘non -toxic’, ‘non -harmful’, ‘non -polluting’,  ‘ecological’ or any other 
statements indicating that the  substance or mixture is not hazardous or any other statements  
that are inconsistent with the cl assification of that substance or  mixture shall not appear on the 
label or packaging of any  substance or mixture.  
(5)Where a mixture conta ins any substance classified as hazardous,  
a) It shall be labell ed in accordance with Part 2 of Annex 2. The statements shall be word ed in 
accordance with Part 3 of Annex 3 and shall be placed in the supplemental information  
section of the label.  14 
 b) The label shall also include the product identifier referred to in  Article 20 and the name, 
address and telephone number of the supplier of the mixture.  
Principles of precedence for hazard pictograms  
ARTICLE  28- (1) Where the classification of a substance or mixture would result in more 
than one haz ard pictogram on the label, the following rules of p recedence s hall apply to 
reduce the number of hazard pictograms required:  
a) if the hazard pictogram ‘GHS01’ applies, the use of the  hazard pictograms  
‘GHS02’ and ‘GHS03’ shall be optional,  except in cases where more than one of these hazard  
pictograms are compulsory;  
b) if the hazard pictogram ‘GHS06’ applies, the hazard  pictogram ‘GHS07’ shall not appear;  
c) if the hazard pictogram ‘GHS05’ applies, the hazard  pictogram ‘GHS07’ shall not appear 
for skin or eye irritation;  
ç) if the hazard pictogram ‘GHS08’ applie s for respiratory sensitisation, the hazard pictogram 
‘GHS07’ shall not appear for skin sensitisation or for skin and eye irritation ; 
d) if the hazard pictogram “GHS02” or “GHS06” applies, the use of the hazard pictog ram 
“GHS04” shall be optional.’.  
(2) Where the classification of a substance or mixture would  result in more than one hazard 
pictogram for the same hazard  class the label shall include the hazard pict ogram 
corresponding to the most severe hazard  category for each hazard class concerned.  
(3) For substances that are included in Part 3 of Annex 6 and also  subject to classification 
pursuant to Part 3 , the label shall include  the hazard pictogram corresponding to the most 
severe hazard  category for each relevant hazard class.  
Principles of p receden ce for hazard statements  
ARTICLE  29- (1) If a substance or mixture is c lassified within several hazard classes or 
differentiations of a hazard class, all hazard st atements resulting from the classification sh all 
appear on the label, unless there is evident  duplication or redundancy.  
Principles of precedence for precautionary statements  
ARTICLE  30- (1)Where the selection of the p recautionary statements results in certain 
precautionary statem ents being clearly redundant or unnecessary given the specific s ubstance, 
mixture or packaging, such statements shall be omitted from the label.  
(2) Where the substance or mix ture is supplied to the general public, one precautionary 
statement addressing the disposal of that substance or mixture as we ll as the disposal of 
packaging shall appear on the label, unless  not required under Article 24. In all other cases, a 
precautionar y statement addressing disposal shall not be required, where it is  clear that the 
disposal of the substance or mixture or the  pack aging does not present a hazard to human 
health or the environment.  
(3) Not more than six precautio nary statements shall appear on the label, unless necessary to 
reflect the nature and the severity of the hazards.  
Exemptions from labelling and packagi ng requirements  
ARTICLE  31- (1)Where the packaging of a substance or a mixture is either in such a shape 
or form  or is so small that it is impossible to meet the requirements of Article 3 3 for a label in 
another language together with Turkish, the label elements in accordance with Article 1 9(2) 
shall be provided in accordance with section 1.5.1 of Annex 1. 
(2) If the full label information cannot be provided in the way  specified in paragraph 1 the 
label information may be reduced in accordance with section 1. 5.2 of Annex 1. 
(3) When a hazardous substance or mixture referred to in Part 5  of Annex 2 is supplied  to 
the general public without packaging it shall be accompanied by a copy of the label elements 
in accordance with Article 1 9. 
 
 15 
 Updating information on labels  
ARTICLE  32-(1) The supplier shall ensure tha t the label is updated, without undue delay, 
following any change to the class ification and labelling of that substance or m ixture, where 
the new hazard is more severe or where new supp lemental labelling elements are required 
under Article 2 7, taking  into account the nature of the change as regards the protection of 
human health and  the environment. Suppliers sha ll cooperate in accordance with Article 
6(1)(ğ) to complete the changes to t he labelling without  undue delay.  
(2) Where labelling change s are required other than those referred to in paragraph 1, the 
supplier shall ensure that th e label is updated within 18 months.  
(3) The supplier of a substance o r a mixture within the scope of “By-Law on the 
Classification, Packaging and Labelling of Plant Protection Products” published in the 
Official Gazette dated 25/03/2011 and numbered 27885 and” Biocidal Products By -Law” 
published in the Official Gazette dated 31/12/2009 and numbered 27449  (4th Repeting)  shall 
update the label in accordance with those By-Laws . 
General rules for the application of labels  
ARTICLE  33-(1) Labels shall be firmly affixed to one or more surfaces of  the packaging 
immediately containing the substance or mixture and  shall be readable horizontally when the 
package is set down  normally.  
(2) The colour and presentation of any label shall be such that  the hazard pictogram stands out 
clearly.  
(3) The label elements referred to in Article 1 9(1) shall be  clearly and indelibl y marked. They 
shall stand out clearly from  the background and be of such size and spacing as to be easily  
read.  
(4) The shape, colour and the size of a hazard pictogram as well  as the dimensions of the label 
shall be as set out in section 1.2.1  of Annex 1. 
(5) A label shall not be r equired when the label elements referred to in Article 1 9(1) are  
shown clearly on the packaging itself. In such cases, the requirem ents of this Section  
applicable to a label shall be applied to the information shown on the packa ging.  
Location of Information on the Label 
ARTICLE  34-(1) The hazard pictograms, hazard statements,  precautionary statements 
and signal word shall be located together on the label.  
(2) The supplier may decide the order of the hazard statements and precautionary statements 
on the label. However, subject to paragraph 4, all hazard statements and precautionary 
statements shall be grouped on the label by language.  
(3) Groups of hazard statements and groups of precautionary statements referred to in 
paragraph 2 shall be located together on the label by language.  
(4) The supplemental information shall be placed in the supplemental information section 
referred to in Article 27, and shall be located with the other label elements specified in Article 
19(1)(a)  to (f).  
(5) In addition to its use in hazard pictograms, colour may be used on other areas of the label 
to implement special labelling requirements.  
(6) Label elements resulting from the requirements provided for other legislation  acts shall be 
placed in the section for supplemental information on the label referred to in Article 2 7. 
Specific Rules for Labelling of Outer Packaging, Inner Packaging and Single Packaging  
ARTICLE  35- (1) Where a package consists of an outer and an inner packaging, together 
with any intermediate packaging, and the outer packaging meets labelling provisions in 
accordance with the rules on the transport of dangerous goods, the inner and any intermediate 
packaging shall be labelled in accordance with this By -Law. The outer packaging may also be 
labelled in accordance with this By-Law. Where the hazard pictogram(s) required by this By -16 
 Law relate to the same hazard as in the rules for the transport of dangerous goods, the hazard 
pictogram(s) required by this By-Law need not appear on the outer packaging.  
(2) Where the outer packaging of a package is not required to meet labelling provisions in 
accordance with rules on the transport of dangerous goods, both the outer and any inner 
packaging, including any inter mediate packaging, shall be labelled in accordance with this 
By-Law. However, if the outer packaging permits the inner or intermediate packaging 
labelling to be clearly seen, the outer packaging need not be labelled.  
(3) Single packages that meet the label ling provisions in accordance with the rules on the 
transport of dangerous goods shall be labelled both in acco rdance with this By -Law and the 
rules on the transport of dangerous goods. Where the hazard pictogram(s) required by  this By -
Law relate to the sa me hazard as in rules on the transport of dangerous goods, the hazard 
pictogram(s) required b y this By -Law need not appear on the outer packaging.  
Hazard Communication  
ARTICLE  36 –(1) Informations about the hazards of the  hazardous  substance and mixture 
are communicated via the label.  
SECTION  FIVE  
Packaging  
 
Requirements of Packaging  
ARTICLE  37-(1) Packaging containing hazardous substances or mixtures shall satisfy the 
following requirements:  
a) the packaging shall be designed and constructed so that its contents cannot escape, except 
in cases where other more specific safety devices are prescribed,  
b) the materials constituting the packaging and fastenings shall not be susceptible to damage 
by the contents, or liable to form hazardous compounds with the contents,  
c) the packaging and fastenings shall be strong and solid  throughout to ensure that they will 
not loosen and will  safely meet the normal stresses and strains of handling;  
ç) packaging fitted with replaceable fastening  devices shall be designed so that it can be 
refastened repeatedly without the contents escaping.  
(2) Packaging containing a hazardous substance or a mixture supplied to the general public  
shall satisfy the following requirements:  
a) Packaging shall not have either a shape or design likely to attract or arouse the active 
curiosity of children or to mislead consumers, or have a similar presentation or a design used 
for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead  
consumers . 
b) Where the packaging contains a substance or mixture which meets the requirements in 
section 3.1.1 of Annex 2 it shall have a child -resistant fastening in accordance with sections 
3.1.2, 3.1.3 and 3.1.4 of Annex  2. 
c) Where the packaging contains a substance or mixture which meets the requirements in 
section 3.2.1 of Annex 2 it shall bear a tactile warning of danger in accordance with section 
3.2.2 of  Annex 2. 
(3) The packaging of substances and mixtures shall be deemed  to satisfy the requirements of 
paragraph 1(a), (b) and (c) if it complies with the requirements of the rules on the transport of 
dangerous goods by rail, road, air, inland waterways or sea.  
 
 
 
 
 17 
 SECTION  SIX 
Harmonisation of Classification and Labelling of Substances and  
the Classification and Labelling Inventory  
 
Harmonisation of Classification and Labelling of Substances  
ARTICLE  38-(1) A substance that fulfils the criteria set out in Annex 1 for the following 
shall normally be subject to harmonised classification and labelling in accordance with Article 
39: 
a) respiratory sensitisation, category 1 (Annex 1, section 3.4),  
b) germ cell mutagenicity, category 1A, 1B or 2 (Annex 1, section 3.5);  
c) carcinogenicity, category 1A, 1B or 2 (Annex 1, section 3.6);  
ç) reproductive toxicity, category 1A, 1B or 2 (Annex  1, section 3.7).  
(2) A substance that is an active substance in the meaning of  By-Law on the Classification, 
Packaging and Labelling of Plant Protection Products  published in the Official Gazette dated 
25/03/2011 and numbered 27885  and Biocidal Products By -Law published in the Official 
Gazette dated 31/12/2009 and numbered 27449  shall normally be subject to harmonised 
classification and labelling. For such substances, the procedures set out in Article 39, 
paragraphs 1, 4, 5 and 6 shall apply.  
(3) Where a substance fulfils the criteria  for other hazard classes or differentiations than those 
referred to in paragraph 1 and does not fall unde r paragraph 2, a harmonised classification and 
labelling in accordance with Article 39 may also be added to Annex 6 on a case -by-case basis, 
if justification is provided demonstrating the need for such action.  
Procedure for Harmonisation of Classification and Labelling of Substances  
ARTICLE  39-(1) A relevant institution  may submit to the Competent Authority a proposal 
for harmonised classification and labelling of substances and, where appropriate, specific 
concentration limits or M -factors, or a proposal for a revision thereof.  The proposal shall 
follow the format set o ut in Part 2 of Annex 6 and contain the relevant information provided 
for in Part 1 of Annex 6. 
(2)  A manufacturer, importer or downstream user of a substance may submit to the 
Competent Authority a proposal for harmonised classification and labelling of that substance 
and, where appropriate, specific concentration limits or M -factors, provided  
that there is no entry in Part 3 of Annex 6 for such a substance in relation to the hazard class 
or differentiation covered by that proposal.  
(3) Where the proposal  of the manufacturer, importer or downstream user concerns the 
harmonised classification and labelling of a substance in accordance with Article 38(3), it 
shall be accompanied by the fee issued on the web site of the Competent authority annually 
which is d etermined in the unit price list of the revolving fund  
(4) Competent Authority shall adopt an opinion on any proposal submitted pursuan t to 
paragraphs 1 or 2 within 18 mon ths of receipt of the proposal, giving the parties concerned the 
opportunity to comme nt.  
(5) Where the Competent Authority finds that the harmonisation of the classification and 
labelling of the substance concerned is appropriate, it shall, without undue delay, submit a 
draft decision concerning the inclusion of that substance together wi th the relevant 
classification and labelling elements in Table 3.1 of Part 3 of Annex 6 and, where appropriate, 
the specific concentration limits or M -factors. A corresponding entry shall be included in 
Table 3.2 of Part 3 of Annex 6 subject to the same conditions,  
(6) Manufacturers, importers and downstream users who have new information which may 
lead to a change of the harmonised classification and labelling elements of a substance in Part 
3 of Annex 6 shall submit a proposal in a ccordance with the paragrap h 2 to the competent 
authority.  18 
 Content of Opinions and Decisions for Harmonised Classification and Labelling and 
Accessibility of Information  
ARTICLE  40- (1) Any opinion referred to in Article 39 (4) and any decision according to 
Article 39(5) shall at least specify for each substance:  
a) Identification of the substance ; 
1) Name(s) in the IUPAC nomenclature or other international chemical name(s)  
2)  Usual name, trade name, abbreviation  
3) EINECS or ELINCs number (if available and appropriate)  
4) CAS name and CAS number (if available)  
5) Other identity code (if available)  
6) Molecular and structural formula (including SMILES notation, if available)  
7) Information on optical activity and typical ratio of (stereo) isomer s (if applicable and 
appropriate)  
8) Molecular weight or molecular weight range  
9) Degree of purity ( %)  
10) Nature of impurities, including isomers and by -products  
11) Percentage of (significant) main impurities  
12) Nature and order of magnitude (… ppm, …  %) of any additives (e.g. stabilising agents or 
inhibitors)  
b) the classification of the substance referred to in Article 38,  including a statement of 
reasons;  
c) specific concentration limits or M -factors, where applicable;  
ç) 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(1);  
d) any other parameter enabling an assessment to be made of the health  or environmental 
hazard of mixtures containing the hazardous substance in question or of substances containing 
such hazardous substances as identified impurities,  additives and constituents, if relevant.  
(2) When making publicly available an opinion or a decision as referred to in Article 3 9(4) 
and (5) of this By-Law, the provisions stated in the third part of Annex 10 shall apply.  
Classification and Labelling Inventory  
ARTICLE  41- (1)Provisions related to the classification and labelling inventory included in 
the Article 42, 43 and 44 shall apply to:   
a) Substances specified in the first, second, third and fourth provisions of Annex 8, 
b) Substances within the scope of Article 2 which meet the criteria for classification as 
hazardous and are placed on the market either on thei r own or in a mixture above the 
concentration limits specified in this By -Law or By-law on the Classification, Packaging and 
Labelling of Dangerous Substanc es and Preparations , where relevant, which results in the 
classificati on of the mixture as hazardous.  
Obligation to Notify  
ARTICLE  42-(1) Any manufacturer or importer, or group of manufacturers  or importers, 
who places on the market a substance referred to  in Article 41 , shall submit the following 
information in order for it to  be included in the inventory referred to in Article 44 , in the 
format that exists  on the Competent Authoriy web site:  
a) 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;  
1) Name, address, telephone number, fax number and e -mail address ; 
2) Contact person ;  
3) Location of the  production ; 
b) The identity of the substance as specified in point (a) of Article 40(1);  19 
 c) The classification of the substance in accordance with Article 15;  
ç) 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;  
d) Specific concentration limits or M -factors, where applicable, in accordance with Article 12 
of this By -Law together with a ju stification using the relevant Parts of  Annex 9; 
e) The label elements specified in points (ç), (d) and (e ) of Article 19 (1) for the substance 
together with any supplemental hazar d statements for the substance, determined in accordance 
with Article 27(1).  
(2) The information listed in paragraph 1 shall be updated and notified to the   
Competent Authority by the notifier(s) concerned when, pursuant to the review in Article 
17(1), a decision to change the classification and labelling of the substance has been tak en. 
(3) Substances placed on the market before 01/01/2015 shall be notified in between 
01/01/2014  and  01/01/2015. Substances placed on the market on or after 01/01/2015  shall be 
notified in accordance with paragraph 1 within one month after their placing  on the market.  
(4) In the case of import of substances on their own or in a mixture;  importer , on the point of 
being responsible for the obligation,  may fulfill the obligations of importers under the scope 
of paragraph (1) (2) and (3), through a representative that is established in Turkey and 
appointed with an agreement  determined by the natural or legal persons settled abroad . 
Agreed Entries  
ARTICLE  43- Where the notification in Article 42( 1) results in different entries on the 
inventory referred to in Article 4 4(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.  
Establishing and Updating of the Classification and Labelling Inventory   
ARTICLE  44- (1) The Competent Authority , shall establish and maintain a classification and 
labelling inventory in the form of a database and provide its persistance.  
(2) Information in the inventory which corresponds to the  information referred to in Part 1 of 
Annex 10 may be publicly accessible.  
(3) The Competent Authority shall update  the inventory when it receives updated information 
in accordance with Article 42 (2) or Article 43.  
 
 
SECTION  SEVEN  
Cooperation , Helpdesk , National Toxicology Information Centre  
 
Cooperation Between Competent Authority and Relevant Institution   
ARTICLE  45- (1) The Competent Authority and the relevant institutions   shall cooperate 
with each other in the performance of their tasks under this By-Law.   
Yardım Masası  
ARTICLE  46- (1) The Competent Authority shall establish national helpdesk to provide  
advice to manufacturers, importers, distributors, downstream  users, article manufacturers and 
any other interested parties on their respective  responsibilities and obligations under this By -
Law.  
 
 
National Toxicology Information Centre  
ARTICLE  47- (1) Within the  meaning of this By -Law, m anufacturers, imp orters and 
downstream users are obliged to inform Ministry of Health National Toxicology Information 
Centre  about the substances in mixtures placed on the market and classified as hazardous on 20 
 the basis of their health or physical effects, including the che mical identity of substances in 
mixtures for which a request for  use of an alternative chemical name has been accepted by the 
Competent Authority , in accordance with Article 2 6. Procedure and format for submission of 
this information is determined by Ministry of Health . 
(2) The National Toxicology Information Centre  shall provide all requisite guarantees  
for maintaining the confidentiali ty of the information received. Such information may only be 
used:  
a)  to meet medical demand by formulating preventative and  curative measures, in particular 
in the event of an  emergency;  
b) where requested by Relevant Institution , to undertake statistical analysis to identify   
where  improved risk management measures may be needed.  
3) The National Toxicology Information Centre  keeps all the information come from 
manufacturers, importers and downstream users under this scope.  
Enforcement   
ARTICLE  48-(1) Relevant Institution  shall implement the required enforcement in 
accordance with legislation in Article (3) to ensure that substances and mixtures are n ot 
placed on the market, unless they have been classified, labelled, notified and packaged in 
accordance with this Regulation.  
Inspection   
ARTICLE  49-(1) Inspections related with provisions of this By-Law is carried out  by 
Relevant Institutions  within the framework of their own legislation.  
 
 
SECTION  EIGHT  
Common and F inal Prov isions 
Advertisement   
ARTICLE  50- (1) Without prejudice to the “By-Law on Distance Selling Contracts ” 
published in the Official Gazette dated 06/03/2011 and numbered 2 7866 , any advertisement 
for a s ubstance classified as hazardous shall mention the hazard classes or hazard categories 
concerned.  
(2) Any advertisement for a mixture classified as hazardous or  covered by Article 27(6) which 
allows a member of the general  public to conclude a contract for purchase without first having  
sight of the label shall mention the type or types of hazard  indic ated on the label.  
Obligation to Mainta in Information and Requests for I nformation  
ARTICLE  51-(1) The supplier shall asse mble and keep available all the information used by 
that supplier for the purposes of classification and labelling und er this By -Law for a period of 
at least 10 years after the su bstance or the mixture was last supplied by that supplier.  
(2) In the event of a supplier ce asing activity, or transferring part or all of his operations to a 
third party, the party responsible for liquidating the sup plier's undertaking or assuming 
responsibility for the placing on the market of the substance or mixtu re concerned shall be 
bound by the obligation in paragraph 1 in  place of the supplier.  
(3) The competent authority may require the supplier to submit to it any information referred 
to paragraph 1.  However, where that information is available to the Competent Authority as  a 
notification pursuant to Article 4 2 of this By-Law, the Competent Authority  shall use that 
information and the relevant institution may request these information from Competent 
Authority . 
Safeguard Clause  
ARTICLE  52-(1) Where a relevant institution has justifiable grounds for believing  that a 
substance or a m ixture, although satisfying the requirements of this By-Law, constitutes a 
serious risk  to human health or the environment du e to reasons of classification, labelling or 21 
 packaging, it m ay take appropriate provisional measures. The relevant institution shall inform 
the Competent Authority thereof, giving the reasons f or its decision within 15 days.  
Amendments to Directive By -Law on the Classification, Packaging and Labelling of 
Dangerous Substances and Preparations  
ARTICLE  53 – (1) By-Law on the Classification, Packaging and Labelling of Dangerous 
Substances and Preparations  published in the Official Gazette dated 26/12/2008 and 
numbered 2 7092 is amended as follows:  
a) in Article 2(2), the subparagraph (c) shall be  deleted;  
b)Article 14(2) shall be  amended as follows:   
“Where there is information on  harmonised  classification and label ling for a particular 
substance has been included in Part 3 of Annex 6 to By-Law on C lassification, Labelling and 
Packaging of Substances and Mixtures , the substance shall be classified in accordance with 
those information and Arti cle 13(1) and Article 14(1) shall not be applied covered by that 
entry. ” 
c) Article 10(1), the subparagraph ( d) shall be  amended as follows:  
“The measures in Article 20 and Article 24(1) shall apply until the substance is listed  in Part 3 
of Annex 6 to By-Law on C lassification, Labelling and P ackaging of Substances a nd 
Mixtures  for the hazard categories covered by that entry  or unti l a decision not to list it has 
been taken in accordance with the procedure laid down in Article 39  of the same By -Law. ” 
ç) Article 12 shall be replaced by the following:  
“Manufacturers, importers and distributors of substances which appear in the EINECS but for 
which no entry has been included in Part 3 of Annex 6 to By-Law on C lassification,  Labelling 
and P ackaging of Substances a nd Mixtures  shall carry out an investigation to make  
themselves aware of the relevant and accessible data whic h exist concerning the proper ties of 
such substances. On the basis of this information, they shall package and provisionally label 
dangerous su bstances according to the rules laid down in Articles 2 0, 21,  24, 25,26,32 and 33 
and the criteria in Annex 1 of this By -Law.’ 
d) Article 21(1), the sub paragraph (e) shall be deleted . 
e)The words ‘Annex 2’ shall be replaced by  ‘Part 3 of Annex 6 to By-Law on Classification, 
Labelling and P ackaging of Substances a nd Mixtures ’ existed in Article  14(3), 16(5), 24(1) 
and 28.   
f)Annex 2 shall be deleted . 
Repeal  of By-Law  
ARTICLE  54-(1)“By-Law on the Classification, Packaging and Lab elling of Dangerous 
Substances and Preparations” published in the Official Gazette dated 26/12/2008 and 
numbered 27092 shall be repealed with effect from 01/06/2016 . 
Transitional provisions  
TRANSITIONAL ARTICLE  1-(1) Substances  and mixtures  shall be classified, labelled and 
packaged u ntil 01/01/2015  and until 01/06/2016  respectively, in accordance with  “By-Law 
on the Classification, Packaging and Labelling of Dangerous Substances and Preparations” . 
(2) By way of derogation from Article 55 o f this Regulation and in addition to the 
requirements  of paragraph 1 of this Articl e, substances and mixtures may, before 01/01/2015  
and 01/06/2016 respectively, be classified, labelled and p ackaged in accordance with this By-
Law. In that case, the provisions on labelling and packaging on “By-Law on the 
Classification, Packaging and Labelling of Dangerous Substances and Preparations ” shall not 
apply . 
(3) From 01/01/2015 until 01/06/2016 , substances shall  be classified in accordance with both 
“By-Law on the Classification, Packaging and Labelling of Dangerous Substances and 
Preparations ”  and  this By -Law. They shall be labelled and packaged in accordance with this 
By-Law.  22 
 (4)By way of derogation from Article 55 of this By -Law, substances classified, labelled and 
packaged in accordance with “By-Law on the Classification, Packaging and Lab elling of 
Dangerous Substances and Preparations ” and already placed on the market before 01/01/2015 , 
are not required to be relabelled and repac kaged in accordance with this  By-Law until 
01/01/2017 . By way of derogation from Article 55 of this Regulation, mixtures classified, 
labelled and p ackaged in accordance with “By-Law on the Classification,  Packaging and 
Labelling of Dangerous Substances and  Preparations ” and already placed on the market 
before 01/06/ 2016  are no t required to be relabelled and repackaged in accordance with this 
By-Law until 01/06/2018 . 
(5) Where a substance or  mixture has been classified in accordance with “By -Law on the 
Classification,  Packaging and Labelling of Dangerous Substances and Preparations ” before 
01/01/2015  or 01/06/2016  respectively, manufacturers, importers or downstream users may 
amend the classification of the substance or mixture using the conversion table in  Annex 7  to 
this By -Law.  
Entry into force  
ARTICLE  55- (1) This By -law shall enter into force on the date of its publication.  
Administration  
ARTICLE  56-(1) The provisions of this By -law are administered by the Minister of 
Environment and Urbanization, Minister of Health and Minister of Food, Agriculture and 
Livestock.