EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEXES 1 to 3  
 
ANNEXES  
to the  
Commission Delegated Regulation  
amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the 
classification, labelling and packaging of substances and mixtures    
EN 1  EN ANNEX I 
 
Annex I to Regulation (EC) No 1272/2008 is amended as follows:    
 
– in Part 3, t he following  section 3.11 . is added:    
 
3.11. Endocrine disrupting property for human health   
 
3.11.1 . Definitions  and general considerations  
 
3.11.1.1 . Definitions  
 
For the purposes of section 3.11, the following definitions shall apply:  
 
(a) ‘endocrine disruptor’ means a substance or a mixture that alters one or more 
functions of the endocrine system and consequently causes adverse effects in an 
intact organism, its progeny, populations or subpopulations;   
(b) ‘endocrine disrupting property’ means the hazard posed by an endocrine disruptor;  
(c)  ‘endocrine disruption’  means the alteration of one or more functions of the 
endocrine system  caused by an endocrine disruptor ; 
(d) ‘endocrine activity’ means an interaction with the endocrine system that may result 
in a response of th at system, of target organs and /or target  tissues , and that confers on 
a substance or the mixture the potential to alter  one or more functions of the 
endocrine system ;  
(e) ‘adverse effect’ means a change in morphology, physiology, growth, development, 
reproduction or lifespan of an organism, system , populat ion or subpopulation that 
results in an impairment of functional capacity, an impairment of the capacity to 
compensate for additional stress or an increase in susceptibility to other influences ;  
(f)  ‘biologically plausible link ’ means the correlation between one or a series of 
biological processes leading to an adverse effect  and an endocrine activity , where the 
correlation is consistent with existing knowledge.  
3.11.1.2. General considerations  
Substances and mixtures which have altered the function of  the endocrine system in well 
performed experimental studies on animals shall be considered to be known, presumed or 
suspected human endocrine disruptors unless there is evidence conclusively demonstrating 
that the adverse effects are not relevant to human s.  
3.11.2 . Classification criteria for substances    
3.11.2.1 . Hazard categories   
For the purpose of classification for endocrine disrupting properties  for human health, 
substances shall be allocated to one of two categories based on strength of evidence and 
additional considerations in a weight of evidence determination  as referred to in section 1.1.1.   
  
EN 2  EN Table 3.11.1 . 
Hazard categories for endocrine disruptors for human health  
Categories   Criteria   
CATEGORY 1   Known or presumed endocrine disruptors 
for human health   
   
The classification in Category 1 shall be  
largely based on evidence from human or 
animal data , or from both human and 
animal data . Such data shall provide 
evidence that the substance meets all the 
following criteria:   
(a) endocrine activity;   
(b) an adverse effect in an intact 
organism or its offspring and future 
generations ;  
(c) a biological ly plausible  link between 
the endocrine activity and the adverse 
effect.   
  
However, where  there is information that 
raises doubt about the relevance of the 
biological ly plausible  link for humans, 
classification in Category 2 may be more 
appropriate.   
  
CATEGORY 2   Suspected endocrine disruptors for human 
health   
 
The classification in Category 2  shall be 
largely based on evidence from human or 
animal data, or from both human and 
animal data.  
 
A substance shall be  classified in Category 
2 where  all the following criteria  are 
fulfilled :  
 
(a) there is  evidence of an endocrine 
activity and an adverse effect  in an 
intact organism or its offspring  and 
future generations ;  
(b) the evidence referred to in (a) is not 
sufficiently convincing to classify the 
substance in Category 1 ;  
(c) there is  evidence of a biologically 
plausible link between the endocrine 
activity and the adverse effect .  
   
EN 3  EN Where there is evidence conclusively demonstrating that the adverse effects are not relevant 
to humans, the substance sh all not be considered an endocrine disruptor for human health.   
3.11.2.2 . Basis of classification    
Classification shall be  made on the basis of the criteria outlined above, and a weight of 
evidence determination of each of the criteria (see section 3.11.2.3 .). Classification as an 
endocrine disruptor for human health is intended to be used for substances which cause or 
may cause  an endocrine -related adverse effect  in humans .   
Where  the endocrine -related adverse effects occur together with other toxic effects, 
endocrine -related adverse effects shall be considered to be present where they are not 
conclusively demonstrated to be a solely  non-specific consequence of the other toxic effects.    
 
3.11.2.3 . Weight of evidence and expert judgment   
3.11.2.3.1. In applying the weight of evidence determination using expert judgment as 
referred to in section 1.1.1 ., all available relevant scientific data shall be considered together , 
such as :  
(a) in vivo studies , studies performed with adequately validated alternative  test systems 
(in vitro, in  silico  studies)   predictive of adverse effects in humans or animals ; 
(b) data from analog ue substances using structure -activity relationship s (SAR) , 
informing about endocrine modes of action ; 
(c) peer-reviewed published studies ; 
(d) any additional acceptable data.    
3.11.2.3.2 . In applying the weight of evidence determination and expert judgment, the 
assessment of the scientific evidence referred to in section 3.11.2.3.1. shall, in particular, 
consider all of the following factors:   
(a)  both positive and negative results;   
(b)  the relevance of the study designs for the assessment of adverse effects and of  
 the endocrine activity;   
(c)  the quality and consistency of the data, considering the pattern and coherence of the 
results within and between studies of a similar design and across different species;   
(d)  the route of exposure, toxicokinetic and metabolism studies;   
(e)  the concept of the limit dose, and international guidelines on maximum 
recommended doses and for assessing confou nding effects of excessive toxicity .   
 
3.11.2.3.3 . Using a weight of evidence determination , the link between the adverse effects and 
the endocrine activity shall be established based on biological plausibility, which shall be 
determined in the light of a vailable scientific knowledge.   Adverse effects that are solely non-
specific  consequences of other toxic effects shall not be considered for the identification of a 
substance as endocrine disruptor.  
 
3.11.2.3.4 . Using a weight of evidence determination , evidence considered for the 
classification of a substance as an endocrine disruptor for the environment referred to in 
section  4.2. shall be considered when assessing the classification of the substance as an 
endocrine disruptor for human health under  section 3.11.    
   
EN 4  EN 3.11.2.4 . Specific consideration s for classification of substances as endocrine disruptors   
Evidence that is to be considered for classification of substances in accordance with other 
sections of this Annex  may also be used for classification of substances as an endocrine 
disruptor where  the criteria  provided in this section  are met .   
 
3.11.2.5 . Application in time  
From  … [OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation] at the latest , substances shall be classified in 
accordance with the criteria lai d down in sections 3.11.2.1 to 3.11.2.4 .   
However, substances which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the da te = the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 3.11.2.1 to 
3.11.2.4  until … [OP please insert the date = the first day of the month following 42 months 
after the date of entry into force of this Regulation] . 
 
3.11.3 . Classification criteria for mixtures   
3.11.3.1 . Classification of mixtures where data are available for all components or only for 
some components  of the mixture   
3.11.3.1.1 . A mixture shall be classified as an endocrine disruptor for human health where at 
least one component has been classified as a Category 1 or Category 2 endocrine disruptor for 
human health and is present at or above t he appropriate generic concentration limit as shown 
in Table 3.11.2 . for Category 1 and Category 2, respectively.    
 
Table 3.11.2 . 
Generic concentration limits of components  of a mixture classified as endocrine 
disruptor for human health that trigger classification of the mixture  
Component classified as:   Generic concentration limits triggering classification of a 
mixture as:   
Category 1 endocrine 
disruptor for human health   Category 2 endocrine 
disruptor for human health   
Category 1 endocrine 
disruptor for human health   ≥ 0,1 %    
Category 2 endocrine 
disruptor for human health     ≥ 1 %   
Note: The concentration limits in this Table shall  apply to solids and liquids (w/w units) as 
well as gases (v/v units).   
3.11.3.2 . Classification of mixtures when data are available for the complete mixture    
3.11.3.2.1 . Classification of mixtures shall  be based on the available test data for the 
individual components of the mixture using concentration limits for the components classified 
as endocrine disruptor for human health. On a case -by-case basis, test data on the mixture as a 
whole  may be used for classification when demonstrating  endocrine -related adverse  effects 
that have not been established from the evaluation based on  the individual components . In 
such cases, the test results for the mixture as a whole must be shown to be conclusive taking  
EN 5  EN into account dose and other factors such as duration, observations, sensitivity and statistical 
analysis of the test systems. Adequ ate documentation supporting the classification shall be 
retained and made available for review upon request.   
 
3.11.3.3 . Classification of mixtures where data are not available for the complete mixture: 
bridging principles    
 
3.11.3.3.1 . Where the mixture itself has not been tested to determine its endocrine disrupting 
properties  for human health, but there are sufficient data on the individual components  and 
similar tested mixtures (subject to paragraph 3.11.3.2.1 .) to adequately  characterise  the 
hazards of the mixture, those  data shall be used in accordance with the applicable bridging 
principles set out in section 1.1.3.  
   
3.11.3.4 .  Application in time  
From  … [OP please insert the date = the first day of the month following 36 months after the 
date of entry into force of this Regulation] at the latest, mixtures  shall be classified in 
accordance with the criteria laid down in sections 3.11.3.1. , 3.11.3.2. and  3.11.3.3.  
However,  mixtures which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before  … [OP please insert the date = the first day of 
the month following 36 months after the  date of entry into force of this Regulation]  are not 
required to be re classified in accordance with the criteria laid down in sections 3.11.3.1. , 
3.11.3.2. and  3.11.3.3. until … [OP please insert the date = the first day of the month 
following 60 months a fter the date of entry into force of this Regulation] . 
3.11.4 . Hazard Communication    
 
3.11.4.1 . Label elements shall be used in accordance with Table 3.11.3 . for substances and 
mixtures meeting the criteria for classification in this hazard class  (Endocrine disrupting 
property for human health ).  
 
Table 3.11.3 .  
Label elements of endocrine disrupting properties for human health   
 
Classification   Category 1   Category 2   
Symbol/pictogram     
Signal Word   Danger   Warning   
Hazard Statement   EUH380: May cause 
endocrine disruption in 
humans   EUH381: Suspected of 
causing endocrine 
disruption in humans   
Precautionary Statement 
Prevention   P201   
P202   
P263   
P280   P201   
P202   
P263   
P280   
Precautionary Statement 
Response   P308 + P313   
  P308 + P313   
  
Precautionary Statement 
Storage   P405   P405   
Precautionary Statement 
Disposal   P501   P501    
EN 6  EN ’ 
3.11.4.2. Application in time for substances  
 
From … [ OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation]  at the latest, substances shall be labelled in 
accordance with section  3.11.4.1.  
 
However, substances which are labelled in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of  entry into force of this Regulation] 
and which were placed on the market before … [OP please insert the date = the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accor dance with section 3.11.4.1 until … [OP please insert the 
date = the first day of the month following 42 months after the date of entry into force of this 
Regulation] . 
 
3.11.4.3. Application in time for mixtures  
 
From … [OP please insert the date = the fir st day of the month following 36 months after the 
date of entry into force of this Regulation]  at the latest, mixtures shall be labelled in 
accordance with  section  3.11.4.1.  
 
However , mixtures which are labelled in accordance with this Regulation as applicable on … 
[OP please insert the date = the day before the date of entry into force of this Regulation]  and 
which were placed on the market before … [OP please insert the date = the f irst day of the 
month following 36 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accordance with section 3.11.4.1 until … [OP please insert the 
date = the first day of the month following 60 months after  the date of entry into force of this 
Regulation] .’; 
 
(2) in Part 4 , the following section s 4.2., 4.3. and 4.4.  are added:    
 
‘4.2. Endocrine disrupting property  for the environment    
 
4.2.1 . Definitions and general considerations    
 
4.2.1.1. Definitions  
 
For the purposes of section 4.2., the following definitions  shall apply:   
 
(a)  ‘endocrine disruptor’ means a substance or a mixture that alters one or more 
functions of the endocrine system and consequently causes adverse effects in an 
intact organism, i ts progeny, populations or subpopulations;   
(b)  ‘endocrine disrupting property’ means the hazard posed by an endocrine disruptor;  
(c)  ‘endocrine disruption’  means the alteration of one or more functions of the endocrine 
system  caused by an endocrine disr uptor ;  
(d)  ‘endocrine activity’ means an interaction with the endocrine system that may result 
in a response of that system, of target organs and/or target tissues  and that confers on   
EN 7  EN a substance  or mixture  the potential to alter  one or more functions of the endocrine 
system;   
(e)  ‘adverse effect’ means a change in morphology, physiology, growth, development, 
reproduction or lifespan of an organism, system, population or subpopulation that 
results in an impairment of functional c apacity, an impairment of the capacity to 
compensate for additional stress or an increase in susceptibility to other influences;    
(f)  ‘biologically plausible link’ means the correlation between one or a series of 
biological processes leading to an adverse effect  and an endocrine activity , where th e 
correlation is consistent with existing knowledge . 
 
4.2.1.2. General considerations  
Substances and mixtures which have altered the function of the endocrine system in well 
performed experimental studies o n animals shall be considered to be known, presumed or 
suspected endocrine disruptors for the environment unless there is evidence conclusively  
demonstrating  that the adverse effects identified are not relevant at the (sub)population level .  
 
 
4.2.2 Classification criteria for substances    
 
4.2.2.1 Hazard categories   
For the purpose of classification for endocrine disrupting properties  for the environment, 
substances shall be allocated to one of two categories based on strength of evidence and 
additio nal considerations in a weight of evidence determination .  
 
Table 4.2.1 .  
Hazard categories for endocrine disruptors for the environment   
 
Categories   Criteria   
CATEGORY 1   Known or presumed endocrine disruptors 
for the environment   
   
The classification in Category 1 shall be 
largely based on evidence from animal 
data. Such data shall provide evidence that 
the substance meets all the following 
criteria:   
(a) endocrine activity;  
(b) an adverse effect in an intact 
organism or its  offspri ng and  future 
generations;  
(c) a biological ly plausible  link 
between the endocrine activity and the 
adverse effect .  
  
However, whe re there is information that 
raises doubt about the relevance of the 
endocrine disrupting adverse effects for the 
population or subpopulation level, 
classification in Category 2 may be more 
appropriate.    
EN 8  EN  
CATEGORY 2   Suspected endocrine disruptors for the 
environment   
 
The classification in Category 2  shall be 
largely based on evidence from animal 
data.  
 
A substance shall be  classified in Category 
2 where all the following criteria are met :  
(a) there is evidence of an endocrine 
activity and an adverse effect  in an 
intact organism or  its offsp ring and  
future generations;   
(b) the evidence referred to in point (a)  
is not sufficiently convincing to 
classify the substance in Category 1 ;  
(c) there is  evidence of a plausible 
biological link between the endocrine 
activity and the adverse effe ct. 
  
 
Where there is evidence conclusively demonstrating that the adverse effects identified are not 
relevant at the population or subpopulation level, the substance may not  necessarily  be 
considered an endocrine disruptor for the environment.   
 
4.2.2.2 . Basis of classification  
   
Classification shall be  made on the basis of the appropriate criteria  set out in section 4.2. 2.1, 
and an assessment of the weight of evidence of each of the criteria (see section 1.1.1 .). 
Classification as an endocrine disruptor for th e environment is intended to be used for 
substances which cause or may cause  an endocrine -related adverse effect  at (sub) population  
level .   
Where the endocrine -related adverse effects occur together with other toxic effects, 
endocrine -related adverse effects shall be considered to be present where they are not 
conclusively demonstrated to be a solely non -specific consequence of the other toxic effects.    
 
4.2.2.3 . Weight of evidence  and expert judgment   
 
4.2.2.3.1 . In applying the weight of evidence determination using expert judgment as referred 
to in section 1.1.1., all available relevant scientific data shall be considered together , such as :  
(a) in vivo studies, studies performed with adequately validated alternative test systems 
(in vitro, in silico studies)   predictive of adverse effects in humans or animals ; 
(b) data from analog ue substances using structure -activity relationships (SAR), 
informing about endocrine modes of action;  
(c) peer-reviewed published studies;  
(d) any additional acceptable data.    
  
EN 9  EN  
4.2.2.3.2 . In applying the weight of evidence determination, the assessment of the scientific 
evidence referred to in section 4.2.2.3.1. shall, in particular, consider all of the following 
factors:   
 
(a) both positive and negative results;  
(b) the relevance of the study design for the assessment of adverse effects and its 
relevance at the population or subpopulation level, and for the assessment of the 
endocrine activity;   
(c) the adverse effects on reproduction, growth/development, and other releva nt adverse 
effects which are likely to impact on populations or subpopulations;   
(d) the quality and consistency of the data, considering the pattern and coherence of the 
results within and between studies of a similar design and across different taxonomic 
groups;  
(e) the route of exposure, toxicokinetic and metabolism studies . 
 
4.2.2.3.3 . Using a weight of evidence determination , the link between the adverse effects and 
the endocrine activity shall be established based on biological plausibility, which shall be 
determined in the light of available scientific knowledge.   Adverse effects that are solely non-
specific consequences of other toxic effects shall not be considered for the identification of a 
substance as endocrine disruptor.  
 
4.2.2.3.4 . Using a weight of  evidence determination , evidence considered for the classification 
of a substance as an endocrine disruptor for human health in section 3.11 . shall be considered 
to assess the classification of the substance as endocrine disruptor for the environment in 
section 4.2 .  
 
4.2.2.4 . Specific consideration for classification as environmental endocrine disruptor   
Evidence that is to be considered for classification of substances in accordance with other 
sections of this Annex  may also be used for classification o f substances as an endocrine 
disruptor where the criteria  provided in this section  are met .   
 
4.2.2.5. Application in time  
From  … [OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation] at the latest , substances shall be classified in 
accordance with the criteria lai d down in sections 4.2.2.1 to 4.2.2.4.  
Howev er, substances which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date =  the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.2.2.1 to 
4.2.2.4  until … [OP please insert the date = the first day of the month following 42 months 
after the date of entry into force of this Regulation] . 
 
4.2.3 . Classification criteria for mixtures     
EN 10  EN  
4.2.3.1 . Classification of mixtures whe re data are available for all components  or only for 
some components  of the mixture    
 
4.2.3.1.1 . The mixture shall be classified as an endocrine disruptor for the environment whe re 
at least one component has been classified as a Category 1 or Category 2 endocrine disruptor 
for the environment and is present at or above the  appropriate generic concentration limit as 
shown in Table 4.2.2 . for Category 1 and Category 2, respectively.   
 
Table 4.2.2 .  
Generic concentration limits of components of a mixture classified as endocrine 
disruptor for the environment that trigger classification of the mixture   
Component classified as:   Generic concentration limits triggering classification of a 
mixture as:   
Category 1 endocrine 
disruptor for the 
environment   
  Category 2 endocrine 
disruptor for the 
environment   
  
Category 1 endocrine 
disruptor for the 
environment   ≥ 0,1 %    
Category 2 endocrine 
disruptor for the 
environment     ≥ 1 %   
Note: The concentration limits in this Table apply to solids and liquids (w/w units) as well as 
gases (v/v units).   
 
4.2.3.2 . Classification of mixtures whe re data are available for the complete mixture    
 
4.2.3.2.1 .  
Classification of mixtures shall be based on the available test data for the individual 
components of the mixture using concentration limits for the components cla ssified as 
endocrine disruptor for the environment . On a case -by-case basis, test data on the mixture as a 
whole may be used for classification when demonstrating endocrine -related adverse effects 
that have not been established from the evaluation based on  the individual components. In 
such cases, the test results for the mixture as a whole must be shown to be conclusive taking 
into account concentration  and other factors such as duration, observations, sensitivity and 
statistical analysis of the test syste ms. Adequate documentation supporting the classification 
shall be retained and made available for review upon request.   
 
4.2.3.3 . Classification of mixtures whe re data are not available for the complete mixture: 
bridging principles    
 
4.2.3.3.1 . Where the mixture itself has not been tested to determine its endocrine disrupting 
properties for the environment, but there are sufficient data on the individual components and 
similar tested mixtures (subject to paragraph 4.2.3.2.1 .) to adequately chara cterise the hazards 
of the mixture, those  data shall be used in accordance with the applicable bridging principle s 
set out in section 1.1.3 .   
 
4.2.3.4. Application in time   
EN 11  EN From  … [OP please insert the date = the first day of the month following 36 months after the 
date of entry into force of this Regulation] at the latest , mixtures shall be classified in 
accordance with the criteria lai d down in sections 4.2.3.1 to 4.2.3.3.  
However, mixtures which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date = the first day of 
the month following 36 months after the date of entry in to force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.2.3.1 , 4.2.3.2 
and 4.2.3.3  until … [OP please insert the date = the first day of the month following 60 
months after the date of entry into force of this Regulation] . 
 
4.2.4 . Hazard Communication    
 
4.2.4.1 . Label elements shall be used in accordance with Table 4.2.3 ., for substances or 
mixtures meeting the criteria for classification in this  hazard class  (Endocrine disrupting 
properties for the environment) .  
 
Table 4.2.3 .  
Label elements of endocrine disrupting properties for the environment   
Classification   Category 1   Category 2   
Symbol/pictogram     
Signal Word   Danger   Warning   
Hazard Statement   EUH430: May cause 
endocrine disruption in the 
environment   EUH431: Suspected of 
causing endocrine 
disruption in the 
environment   
Precautionary Statement 
Prevention   
  P201   
P202   
P273   
  P201   
P202   
P273   
Precautionary Statement 
Response   
  P391   P391   
Precautionary Statement 
Storage   
  P405   P405   
Precautionary Statement 
Disposal   P501   P501   
 
4.2.4.2. Application in time for substances  
From … [ OP please insert the date = the first day of the month following 18 months after the 
date of entry into forc e of this Regulation]  at the latest, substances shall be labelled in 
accordance with section 4.2.4.1.  
However, substances which are labelled in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry  into force of this Regulation ] 
and which were placed on the market before … [ OP please insert the date = the first day of 
the month following 18 months after the date of entry into force of this Regulation ] are not 
required to be relabelled in accordance with section 4.2.4.1 until … [ OP please insert the date  
EN 12  EN = the first day of the month following 42 months after the date of entry into force of this 
Regulation ] 
 
4.2.4.3. Application in time for mixtures  
 
From … [OP please insert the date = the first day of  the month following 36 months after the 
date of entry into force of this Regulation]  at the latest, mixtures shall be labelled in 
accordance with section 4.2.4.1.  
 
However , mixtures which are labelled in accordance with this Regulation as applicable on … 
[OP please insert the date = the day before the date of entry into force of this Regulation]  and 
which were placed on the market before … [OP please insert the date = the first day of the 
month following 36 months after the date of entry into force of this  Regulation]  are not 
required to be relabelled in accordance with section 4.2.4.1 until … [OP please insert the date 
= the first day of the month following 60 months after the date of entry into force of this 
Regulation] . 
 
 
4.3. Persistent, Bioaccumulative  and Toxic (PBT) or Very Persistent, Very 
Bioaccumulative (vPvB)  properties     
 
4.3.1. Definition s  
 
For the purposes of Section 4.3., the following definitions shall apply:  
 
“PBT” means a persistent, bioaccumulative and toxic substance or mixture that meets the 
classification criteria set out in section 4.3.2.1.    
 
“vPvB ” means a very persistent and very bioaccumulative substance or mixture that meets the 
classification criteria set out in section 4.3.2.2.   
 
4.3.2. Classification criteria for substances   
 
4.3.2.1 . Classification criteria for PBT   
A substance that fulfils the persistence , bioaccumulation and toxicity criteria set out in 
sections 4.3.2.1.1. to 4.3.2.1. 3 shall be considered a PBT substance.   
 
4.3.2.1.1. Persistence   
 
A substance shall be considered to  fulfil the persistence  criterion (P) where  any of the 
following conditions is met:    
 
(a) the degradation half -life in marine water is higher than 60 days;    
(b) the degradation half -life in fresh or estuarine water is higher than 40 days;   
(c) the degradation half -life in marine sediment is higher than 180 days;   
(d) the degradation half -life in fresh or estuarine water sediment is higher than 120 
days;   
(e) the degradation half -life in soil is higher than 120 days.     
EN 13  EN  
4.3.2.1.2. Bioaccumulation   
 
A substance shall be considered to fulfil the bioaccumulation criterion (B) where the 
bioconcentration factor in aquatic species is higher than 2000.   
 
4.3.2.1.3. Toxicity   
 
A substance shall be considered to fulfil the toxicity criterion (T) in any of the following 
situations:    
(a) the long -term no -observed effect concentration (NOEC) or EC10 for marine or 
freshwater organisms is less than 0,01 mg/l;   
(b) the substance meets the criteria for classification as carcinogenic (category 1A or 
1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 
1A, 1B, or 2)  according to sections 3.5., 3.6 or 3.7;  
(c) there is other evidence of chronic toxicity, as identified by the substance meeting the 
criteria for classification: specific target organ toxicity after repeated exposure 
(STOT RE category 1 or 2) according to section 4.1;   
(d) the substance meets the cri teria for classification as endocrine disruptor ( Category 1) 
for humans or the environment according to sections 3.11 . or 4.2 .   
 
4.3.2.2 . Classification criteria for vPvB   
 
A substance that fulfils the persistence and bioaccumulation criteria set out in sections 
4.3.2.2.1 and 4.3.2.2.2. shall be considered a vPvB substance.   
 
4.3.2.2.1. Persistence   
 
A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) where  any of the 
following conditions is met:   
(a) the degradation half-life in marine, fresh or estuarine water is higher than 60 days;   
(b) the degradation half -life in marine, fresh or estuarine water sediment is higher than 
180 days;   
(c) the degradation half -life in soil is higher than 180 days.   
 
4.3.2.2.2 . Bioaccumulation   
 
A substance shall be considered to fulfil the ‘very bioaccumulative’ criterion (vB) whe re the 
bioconcentration factor in aquatic species is higher than 5 000.   
 
4.3.2.3 . Basis of classification   
 
For the classification of  PBT substances and vPvB  substances, a weight  of evidence 
determination using expert judgement shall be applied, by comparing all relevant and 
available information listed in section 4.3.2.3 with the criteria set out in section s 4.3.2.1 . and 
4.3.2.2 . That weight of evidence  shall be applied in particular where the criteria set out in 
section s 4.3.2.1 . and 4.3.2.2 . cannot be  applied directly to the available information.    
  
EN 14  EN The information used for the purposes of assessment of the  PBT/vPvB  properties  shall be 
based o n data obtained under relevant conditions.   
 
The identification shall also take account of the  PBT/vPvB  properties  of relevant constituents 
or impurities of a  substance   and relevant transformation and/or  degradation  products.   
 
This hazard class (Persistent, Bioaccumulative and Toxic (PBT) or Very Persistent, Very 
Bioaccumulative (vPvB) properties )) shall apply to all organic substances, including organo -
metals.   
 
4.3.2.3.1 . Assessment of P or vP properties  
 
 The following information shall be considered for the assessment of P properties:  
(a) results from simulation testing on degradation in surface water;   
(b) results from simulation testing on degradation in soil;   
(c) results from simulation testing on degradation in sediment;   
(d) other information, such as information from field studies or monitoring studies, 
provided that its suitability and reliability can be reasonably demonstrated.   
 
4.3.2.3.2 . Assessment of B or vB properties   
 
The following information shall be considered for the a ssessment of B or vB properties:  
(a) results from a bioconcentration or bioaccumulation study in aquatic species;   
(b) other information on the bioaccumulation potential , provided that its suitability and 
reliability can be reasonably demonstrated, such as:  
(i) results from a bioaccumulation study in terrestrial species;    
(ii) data from scientific analysis of human body fluids or tissues, such as 
blood, milk or fat;    
(iii) detection of elevated levels in biota, in particular in endangered species 
or in   vulnerable populations, compared to levels in their surrounding 
environment;    
(iv) results from a chronic toxicity study on animals;    
(v) assessment of the toxicokinetic  behaviour  of the substance . 
(c) information on the ability of the substance to  biomagnify  in the food chain, where 
possible expressed by biomagnification factors or trophic magnification factors . 
 
4.3.2.3.3 . Assessment of T properties    
 
The following information shall be considered for the assessment of T properties:  
(a) results from long -term toxicity testing on aquatic invertebrates;    
(b) results from long -term toxicity testing on fish;    
(c) results from growth inhibition study on aquatic  plants;     
EN 15  EN (d) the substance meeting the criteria for classification as carcinogenic in Category 1A 
or 1B (assigned hazard phrases: H350 or H350i), germ cell mutagenic in Category 
1A or 1B (assigned hazard phrase: H340), toxic for reproduction in Category 1A, 1B 
and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, 
H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after repeated 
dose in Category 1 or 2 (assigned hazard phrase: H372 or H373);   
(e) the substance meeting the criteria for classification as endocrine disruptor ( Category 
1) for human health or the environment (assigned hazard phrases: EUH380 or 
EUH430);   
(f) results from long-term toxicity testing on terrestrial organisms; invertebrates and 
plants ; 
(g) results fr om long-term toxicity testing on sediment organisms ; 
(h) results from long -term or reproductive toxicity testing with birds;    
(i) other information , provided that its suitability and reliability can be reasonably 
demonstrated .   
 
4.3.2.4 . Weight of evidence and expert judgment   
 
4.3.2.4.1 . In applying the weight of evidence determination using expert judgment as referred 
to in section 1.1.1., all available relevant scientific data shall be considered together, such as:  
(a) suitable in vivo tests or adequately validated alternative test systems (in vitro, in 
silico studies) in humans or animals;  
(b) information from the application of the category approach (grouping, read -across);  
(c) (Q)SAR results informing about P, vP, B, vB and T properties;  
(d) results of monitoring and modelling;  
(e) human experience such as occupational data and data from accident databases;  
(f) epidemiological and clinical studies;  
(g) well documented case reports, peer -reviewed published studies and observations;  
(h) any ad ditional acceptable data.    
The quality and consistency of the data shall be given appropriate weight. The available 
results regardless of their individual conclusions shall be assembled together in a single 
weight  of evidence determination.  
 
 
4.3.2.4.2 . In applying the weight of evidence determination, the following information, in 
addition to the information referred to in sections 4.3.2.3.1, 4.3.2.3.2 and 4.3.2.3.3, shall be 
considered as part of the scientific assessment of the information relevant fo r the P, vP, B, vB 
and T properties :   
 
(a) Indication of P or vP properties :   
(i) Results from tests on ready biodegradation;    
EN 16  EN (ii) Results from other degradation screening tests (e.g. enhanced ready test, 
tests on inherent biodegradability);   
(iii) Results obtained from biodegradation (Q)SAR models in accordance 
with Section 1.3 of Annex XI to Regulation (EC) No 1907/2006;   
(iv) Other information provided that its suitability and reliability can be 
reasonably demonstrated .  
(b) Indication of B or vB properties :  
(i) Octanol -water partitioning coefficient experimentally determined or 
estimated by (Q)SAR models in accordance with Section 1.3 of Annex 
XI to Regulation (EC) No 1907/2006 ;  
(ii) Other information provided that its suitability and reliability can be 
reasonably demonstrated.   
(c) Indication of T properties :  
(i) Short -term aquatic toxicity  (e.g. results from acute toxicity testing on 
invertebrates, aquatic plants or fish, in vitro acute toxicity testing on fish 
cell line) ;  
(ii) Othe r information provided that its suitability and reliability can be 
reasonably demonstrated.   
 
4.3.2.5. Application in time  
From  … [OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation] at the latest , substances shall be classified in 
accordance with the criteria lai d down in sections 4.3.2.1 to 4.3.2.4.  
Howev er, substances which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date =  the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.3.2.1 to 
4.3.2.4  until … [OP please insert the date = the fir st day of the month following 42 months 
after the date of entry into force of this Regulation] . 
 
4.3.3. Classification criteria for mixtures  
 
4.3.3.1. A mixture shall be classified respectively as a PBT or vPvB when at least one 
component contained in the mixture has been classified respectively as a PBT or vPvB and is 
present at or above 0 ,1% (weight/weight).   
  
4.3.3. 2. Application in time  
From  … [OP please insert the date = the first day of the month following 36 months after the 
date of entry into force of this Regulation] at the latest , mixtures shall be classified in 
accordance with the criteria lai d down in sections 4.3.2.1 to 4.3.2.4.  
 
However , mixtures which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date = the first day of  
EN 17  EN the month following 36 months after the date of entry  into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.3.2.1 to 
4.3.2.4  until … [OP please insert the date = the first day of the month following 60 months 
after the date of entry into fo rce of this Regulation] . 
 
4.3.4. Hazard communication   
 
4.3.4.1. Label elements shall be used in accordance with Table 4.3.1 ., for substances or 
mixtures meeting the criteria for classification in this hazard class.   
 
Table 4.3.1 .  
Label elements for PBT and vPvB properties   
 
  PBT  vPvB   
Symbol/pictogram      
Signal word   Danger   Danger   
Hazard Statement   EUH440: Accumulates in 
living organisms including 
in humans with long - lasting 
effects   EUH441: Strongly 
accumulates in living 
organisms including in 
humans with possible long - 
lasting effects   
Precautionary Statement 
Prevention   P201   
P202   
P273   P201   
P202   
P273   
Precautionary Statement 
Response   P391   P391   
Precautionary Statement 
Disposal   P501   P501   
 
4.3.4.2. Application in time for substances  
 
From … [ OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation]  at the latest, substances shall be labelled in 
accordance with section 4.3.4.1.  
 
However , substances which are labelled in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation] 
and which were placed on the market before … [OP please insert the date = the  first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accordance with section 4.3.4.1 until … [OP please insert the date 
= the first day of the month following 42 months afte r the date of entry into force of this 
Regulation] . 
 
4.3.4.3. Application in time for mixtures   
 
From … [OP please insert the date = the first day of the month following 36 months after the 
date of entry into force of this Regulation]  at the latest, mixtur es shall be labelled in 
accordance with the provisions laid down in section 4.3.4.1.  
  
EN 18  EN However , mixtures which are labelled in accordance with this Regulation as applicable on … 
[OP please insert the date = the day before the date of entry into force of thi s Regulation]  and 
which were placed on the market before … [OP please insert the date = the first day of the 
month following 36 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accordance with section 4.3.4 .1 until … [OP please insert the date 
= the first day of the month following 60 months after the date of entry into force of this 
Regulation] . 
 
4.4. Persistent, Mobile and Toxic (PMT) or Very Persistent, Very Mobile (vPvM) 
properties    
 
4.4.1 . Definitions   
 
For the purposes of section 4.4., the following definitions shall apply:  
‘PMT ’ means a persistent, mobile and toxic substance or mixture that meets the classification 
criteria set out in section 4.4.2.1 . 
    
‘vPvM ’ means a very persistent and very mobile substance or mixture that meets the 
classification criteria set out in section 4.4.2.2 . 
    
’log K c’ means the common logarithm of the organic carbon -water partition coefficient (i.e.   
Koc).  
 
4.4.2 . Classification  criteria for substances   
 
4.4.2.1 . Classification criteria for PMT    
 
A substance that fulfils the persistence, mobility and toxicity criteria set out in sections 
4.4.2.1.1. , 4.4.4.1.2. and  4.4.2.1. 3. shall be considered  a PMT substance.   
 
4.4.2.1.1.  Persistence   
 
A substance shall be considered to fulfil the persistence criterion (P) in any of the following 
situations:   
(a) the degradation half -life in marine water is higher than 60 days;   
(b) the degradation half -life in fresh or estuarine water is higher than 40 days;   
(c) the degradation half -life in marine sediment is higher than 180 days;   
(d) the degradation half -life in fresh or estuarine water sediment is higher than 120 
days;   
(e) the degradation half -life in soil is higher than 120 days.   
 
4.4.2.1.2.  Mobility   
 
A substance shall be considered to fulfil the mobility criterion (M) when the log K oc is less 
than 3. For an ionisable substance, the mobility criterion shall be considered fulfilled when 
the lowest  log K oc value for pH between 4 and 9 is less than 3 .  
 
4.4.2.1.3. Toxicity    
EN 19  EN A substance shall be considered to fulfil the toxicity criterion (T) in any of the following 
situations:   
(a) the long -term no -observed effect concentration (NOEC) or EC10 for marine or 
freshwater organisms is less than 0,01 mg/l;   
(b) the substance meets the criteria for classification as carcinogenic ( Category 1A or 
1B), germ cell mutagenic ( Category 1A or 1B), or toxic for reproduction ( Category 
1A, 1B, or 2) according to sections 3.5. , 3.6 or 3.7;  
(c) there is other evidence of chronic toxicity, as identified by the substance meeting the 
criteria for classification  as specific target organ toxicity after repeated exposure 
(STOT RE category 1 or 2) according to section 4.1;    
(d) the substance meets the criteria for classification as endocrine disruptor ( Category 1) 
for human health or the environment according to sections 3.11 or 4.2.   
 
4.4.2.2 . Classification criteria for vPvM   
 
A substance that fulfils the persistence and mobility criteria set out  in sections 4.4.2.2.1. and 
4.4.2.2.2   shall be considered a vPvM substance.   
 
4.4.2.2.1.  Persistence   
 
A substance shall be considered to fulfil the ‘very persistent’ criterion (vP) in any of the 
following situations:   
(a) the degradation half -life in marine, fresh or estuarine water is higher than 60 days ;  
(b) the degradation half -life in marine, fresh or estuarine water sediment is higher than 
180 days;   
(c) the degradation half -life in soil is higher than 180 days.   
 
4.4.2.2.2.  Mobility   
 
A substance shall be considered to fulfil the ‘very mobile’ criterion (vM) when the log K oc is 
less than 2.  For an ionisable substance, the mobility criterion shall be considered fulfilled 
when the lowest log K oc value for pH between 4 and 9 is less than 2 .  
  
4.4.2.3 . Basis of classification   
 
For the classification of  PMT  substances and  vPvM  substances , a weight  of evidence 
determination using expert judgment shall be applied, by comparing all relevant and available 
information listed in section 4.4.2.3 with the criteria set out in section s 4.4.2.1 . and 4.4.2.2. 
That weight of evidence  shall be applied in particular where the criteria set out in 
section s 4.4.2.1 . and 4.4.2.2 . cannot be applied directly to the available information.    
 
The information used for the purposes of assessment of the  PMT /vPvM  properties  shall be 
based on data obtained under relevant conditions.   
 
The identification shall also take account of the  PMT/vPvM  properties of relevant 
constituents or impurities of a   substance   and relevant transformation 
and/or  degradation  products.    
EN 20  EN  
This hazard class (PMT  and vPvM properties)  shall apply to all organic substances, including 
organo -metals.   
 
The information set out in sections 4.4.2.3.1 , 4.4.2.3.2. and  4.4.2.3.3.  shall be considered for 
the assessment of P, vP, M, vM and T properties.   
 
4.4.2.3.1 . Assessment of P or vP properties   
 
The following information shall be considered for the assessment of P properties:  
 
(a) results from simulation testing on degradation in surface water;   
(b) results from simulation testing on degradation in soil;  
(c) results from simulation testing on degradation in sediment;   
(d) other information, such as information from field studies or monitoring studies, 
provided that its suitability and reliability can be reasonably demonstrated.   
 
4.4.2.3.1 . Assessment of M or vM properties   
 
The following information shall be considered for the assessment of M or vM properties:  
 
(a) results from adsorption/desorption testing ;  
(b) other information, such as information from leaching studies, provided that its 
suitability and reliability can be reasonably demonstrated.   
 
4.4.2.3. 2. Assessment of T properties   
 
The following information shall be considered for the assessment of T properties:  
 
(a) results from long -term toxicity testing on aquatic invertebrates;   
(b) results from long -term toxicity testing on fish;    
(c) results from growth inhibition study on aquatic plants;    
(d) the substance meeting the criteria for classification as carcinogenic in Category 1A 
or 1B (assigned hazard phrases: H350 or H350i), ge rm cell mutagenic in Category 
1A or 1B (assigned hazard phrase: H340), toxic for reproduction in Category 1A, 1B 
and/or 2 (assigned hazard phrases: H360, H360F, H360D, H360FD, H360Fd, 
H360fD, H361, H361f, H361d or H361fd), specific target organ toxic after  repeated 
dose in Category 1 or 2 (assigned hazard phrase: H372 or H373);   
(e) the substance meeting the criteria for classification as endocrine disruptor ( Category 
1) for human health or the environment (assigned hazard phrases: EUH380 or 
EUH430);  
(f) results from long-term toxicity testing on terrestrial organisms; invertebrates and 
plants;  
(g) results from long-term toxicity testing on sediment organisms;  
(h) results from long -term or reproductive toxicity testing on birds;     
EN 21  EN (i) other information provided that its suitability and reliability can be reasonably 
demonstrated.  
 
4.4.2.4 . Weight of evidence   
 
4.4.2.4.1 . In applying the weight of evidence determination using expert judgment as referred 
to in section 1.1.1., all available relevant scientif ic data shall be considered together, such as:  
(a) suitable in vivo tests or adequately validated alternative test systems (in vitro, in 
silico studies) in humans or animals;  
(b) information from the application of the category approach (grouping, read -across);  
(c) (Q)SAR results informing about P, vP, M, vM and T properties;  
(d) results of monitoring and modelling;  
(e) human experience such as occupational data and data from accident databases;  
(f) epidemiological and clinical studies;  
(g) well documented case reports, peer -reviewed published studies and observations;  
(h) any additional acceptable data.    
The quality and consistency of the data shall be given appropriate weight. The available 
results regardless of their individual conclusions sha ll be assembled together in a single 
weight  of evidence determination.  
 
4.4.2.4.2 . In addition to the information referred to in sections 4.4.2.3.1., 4.4.2.3.2. and 
4.4.2.3.3., in applying weight of evidence determination, the following information  shall b e 
considered as part of the scientific assessment :   
 
(a) Indication of P or vP properties :   
(i) Results from tests on ready biodegradation;   
(ii) results from other degradation screening tests (e.g. enhanced ready test, 
tests on inherent biodegradability);   
(iii) results obtained from biodegradation (Q)SAR models in accordance with 
Section 1.3 of Annex XI to Regulation (EC) No 1907/2006;   
(iv) other information , provided that its suitability and reliability can be 
reasonably demonstrated . 
  
(b) Information relevant for the M or vM properties :  
(i) organic carbon to water partition coefficient (K oc) estimated by (Q)SAR 
models in accordance with Section 1.3 of Annex XI  to Regulation (EC) 
No 1907/2006 ;  
(ii) other information , provided that it s suitability and reliability can be 
reasonably demonstrated.   
  
EN 22  EN (c) Information relevant for the  T properties :  
(i) short-term aquatic toxicity  (e.g. results from acute toxicity testing on 
invertebrates, aquatic plants or fish, in vitro acute toxicity testing on fish 
cell line) ;  
(ii) other information provided that its suitability and reliability can be 
reasonably demonstrated.   
 
4.4.2.5. Application in time  
 
From  … [OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation] at the latest , substances shall be classified in 
accordance with the criteria lai d down in sections 4.4.2.1 to 4.4.2.4.  
 
Howe ver, substances which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date = the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.4.2.1 to 
4.4.2.4  until … [OP please insert the date = the first day of the month following 42 months 
after the date of entry into force of this Regulation] .  
  
4.4.3 . Classification criteria for mixtures   
 
A mixture shall be classified as a PMT or vPvM whe re at least one of its  components  has 
been classified as a  PMT or vPvM and is present at or above 0 ,1% (weight/weight).   
  
From  … [OP please insert the date = the first day of the month following 36 months after the 
date of entry into force of this Regulation] at the latest , mixtures shall be classified in 
accord ance with the criteria lai d down in sections 4.4.2.1 to 4.4.2.4.  
 
However, mixtures which are classified  in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Regulation]  
and which were placed on the market before … [OP please insert the date = the first day of 
the month following 36 months after the date of entry into force of this Regulation]  are not 
required to be reclassified in accordance with the criteria laid down in sections 4.4.2.1 to 
4.4.2.4  until … [OP please insert the date = the first day of the month following 60 months 
after the date of entry into force of this Regulation] . 
 
4.4.4 . Hazard communication  
 
4.4.4.1.  Label elements shall be used in accordance with Tabl e 4.4.1. for substances or 
mixtures meeting the criteria for classification in this hazard class  (PMT  and vPvM 
properties ).  
 
 
Table 4. 4.1.  
Label elements for PMT and vPvM properties   
 
  PMT   vPvM   
Symbol/pictogram      
EN 23  EN Signal word   Danger   Danger   
Hazard Statement   EUH450: Persistent 
substance which can pollute 
water resources   EUH451: Very persistent 
substance which can pollute 
water resources   
Precautionary Statement 
Prevention   P201   
P202   
P273   P201   
P202   
P273   
Precautionary Statement 
Response   P391   P391   
Precautionary Statement 
Disposal   P501   P501 ’ 
 
4.4.4.2. Application in time for substances  
 
From … [ OP please insert the date = the first day of the month following 18 months after the 
date of entry into force of this Regulation]  at the latest, substances shall be labelled in 
accordance with section 4.4.4.  
 
However, substances which are labelled in accordance with this Regulation as applicable on 
… [OP please insert the date = the day before the date of entry into force of this Re gulation] 
and which were placed on the market before … [OP please insert the date = the first day of 
the month following 18 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accordance with section 4.4.4 unt il … [OP please insert the date 
= the first day of the month following 42 months after the date of entry into force of this 
Regulation] . 
 
4.4.4.3. Application in time for mixtures  
 
From … [OP please insert the date = the first day of the month following 36  months after the 
date of entry into force of this Regulation]  at the latest, mixtures shall be labelled in 
accordance with section 4.4.4.  
 
However , mixtures which are labelled in accordance with this Regulation as applicable on … 
[OP please insert the date = the day before the date of entry into force of this Regulation]  and 
which were placed on the market before … [OP please insert the date = the first day of the 
month following 36 months after the date of entry into force of this Regulation]  are not 
required to be relabelled in accordance with section 4.4.4 until … [OP please insert the date 
= the first day of the month following 60 months after the date of entry into force of this 
Regulation] .’ 
 
 
ANNEX II 
 
Part 1  of Annex III to Regulation (EC) No 127 2/2008  is amended as follows:   
 
(1) in Table 1.2, the following rows are added:    
 
‘EUH 380   Language      
EN 24  EN   BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  May cause endocrine disruption in humans   
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 381   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  Suspected of causing endocrine disruption in 
humans   
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK     
EN 25  EN   SL    
  FI    
  SV’;    
 
  
(2) in Table 1.3, the following rows are added:    
 
‘EUH 430   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  May cause endocrine disruption in the 
environment   
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 431   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  Suspected of causing endocrine disruption in 
the environment   
  FR    
  GA    
  HR    
  IT     
EN 26  EN   LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 440   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  Accumulates in living organisms including in 
humans with long lasting effects    
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 441   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL     
EN 27  EN   EN  Strongly accumulates in living organisms 
including in humans with possible long lasting 
effects   
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 450   Language     
  BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  Persistent substance which can pollute water 
resources    
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV    
  
EUH 451   Language      
EN 28  EN   BG    
  ES    
  CS    
  DA    
  DE    
  ET    
  EL    
  EN  Very persistent substance which can pollute  
water resources   
  FR    
  GA    
  HR    
  IT    
  LV    
  LT    
  HU    
  MT    
  NL    
  PL    
  PT    
  RO    
  SK    
  SL    
  FI    
  SV’.    
  
  
  
EN 29  EN ANNEX III 
 
In Part 1, section 1.1.2.1.1., of Annex VI to Regulation (EC) No 1272/2008 , Table 1.1  is 
amended as follows:  
 
(1) the following row is inserted after the row for hazard class ‘Aspiration hazard ’:  
‘  
‘Endocrine disruptor for human health  ED HH 1  
ED HH 2 ’; 
’. 
 
(2) the following rows are inserted after the row for hazard class ‘ Hazardous to the aquatic 
environment ’:  
 
‘Endocrine disruptor for the environment  ED ENV 1  
ED ENV 2  
Persistent, bioaccumulative and toxic  
Very persistent and very bioaccumulative  PBT 
vPvB  
Persistent, mobile and toxic  
Very persistent and very mobile  PMT  
vPvM ’. 
’.