EN    EN EN EN    EN  EUROPEAN COMMISSION 
Brussels,  
. 
Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending, for the purposes of its adaptation  to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the Europe an Parliament and of the Council on 
classification, labelling and packagi ng of substances and mixtures EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of […] 
amending, for the purposes of its adaptation  to technical and scientific progress, 
Regulation (EC) No 1272/2008 of the Europe an Parliament and of the Council on 
classification, labelling and packagi ng of substances and mixtures 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council of 16 December 2008 on classification, labe lling and packaging of substances and 
mixtures, amending and repealing Directiv es 67/548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006
1, and in particular Article 53 thereof, 
Whereas: (1) Regulation (EC) No 1272/2008 harmonises the provisions and criteria for the 
classification and labelling of substances, mi xtures and certain specific articles within 
the European Union.  
(2) That Regulation takes into account the Globa lly Harmonised System of Classification 
and Labelling of Chemicals (hereinafter referred to as ‘the GHS’) of the United 
Nations (UN). 
(3) The classification criteria and labelling rule s of the GHS are periodically reviewed at 
UN level. The third revised edition of the GHS was adopted in December 2008 by the 
United Nations Committee of Experts on th e Transport of Dangerous Goods and on 
the Globally Harmonised System of Cla ssification and Labelling of Chemicals 
(UNCETDG/GHS). It contains amendments concerning, inter alia, the provisions for 
the allocation of hazar d statements and for the labell ing of small packaging, new sub-
categories for respiratory and skin sensiti sation, the revision of the classification 
criteria for long-term hazards (chronic toxi city) to the aquatic environment and a new 
hazard class for substances and mixtures haza rdous to the ozone layer. It is therefore 
necessary to adapt the techni cal provisions and criteria in the Annexes to Regulation 
(EC) No 1272/2008 to the third revised edition of the GHS. 
(4) The GHS allows authorities to adopt supplemental labelling provisions to protect 
individuals already sensitised to a specific ch emical that may elicit a response at very 
                                                
 
1 OJ L 353, 31.12.2008, p. 1.  EN 3   EN low concentration. Requirements should be  introduced to add the name of such 
chemical on the label even if present at  very low concentration in a mixture. 
(5) The terminology of different provisions in the Annexes and certain  technical criteria 
should also be amended to facilitate im plementation by operators and enforcement 
authorities, to improve consistency of the legal text and to enhance clarity. 
(6) To ensure that suppliers of  substances can adapt to th e new classification, labelling 
and packaging provisions introduced by this Regulation, a transitional period should be foreseen and the application of this Regulation should be deferred. This should 
allow for the possibility to apply the pr ovisions laid down in this regulation on a 
voluntary basis before the tr ansitional period is over. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 1272/2008 is amended as follows: 
(1) Article 25(5) is deleted;  
(2) Annex I is amended in accordance with Annex I to this Regulation; 
(3) Annex II is amended in accordance w ith Annex II to this Regulation; 
(4) Annex III is amended in accordance w ith Annex III to this Regulation; 
(5) Annex IV is amended in accordance w ith Annex IV to this Regulation; 
(6) Annex V is amended in accordance w ith Annex V to this Regulation; 
(7) Annex VI is amended in accordance with Annex VI to this Regulation; 
(8) Annex VII is amended in accordance with Annex VII to this Regulation. 
Article 2 
Transitional provisions 
1. By way of derogation from the second paragr aph of Article 3, substances and mixtures 
may, before 1 December 2012 and 1 June 2015 respectively, be classified, labelled and 
packaged in accordance with Regulation (EC)  No 1272/2008 as amended by this Regulation.  
 2. Suppliers who do not make use of the possi bility set out in paragraph 1, shall by 1 
December 2014 relabel and repackage in acco rdance with Regulation (EC) No 1272/2008 as 
amended by this Regulation substances plac ed on the market before 1 December 2012.  EN 4   EN  
Suppliers who do not make use of the possibility set out in paragraph 1, shall by 1 June 2017 
relabel and repackage in accordance with Regul ation (EC) No 1272/2008 as amended by this 
Regulation mixtures placed on the ma rket before 1 June 2015. Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply in respect of substances from 1 December 2012 and in respect to mixtures from 
1 June 2015.  
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
 
 
 
Done at Brussels, […] 
 For the Commission 
 […]  The President EN 5   EN ANNEX I  
A. Part 1 of Annex I to Regulation (E C) No 1272/2008 is amended as follows: 
(1) In section 1.1.2.2.2, the Note under Tabl e 1.1 is replaced by the following: 
“Note:  
Generic cut-off values are in weight per centages except for gaseous mixtures where 
they may be best described in volume percentages.”; 
(1) In section 1.1.3.1, the beginning of the firs t sentence is replaced by “If a tested 
mixture”; 
(2) Sections 1.1.3.2, 1.1.3.3 and 1.1.3.4 are replaced by the following: 
“1.1.3.2. Batching  
The hazard category of a tested production ba tch of a mixture can be assumed to be 
substantially equivalent to that of another untested pr oduction batch of the same 
commercial product, when produced by or unde r the control of the same supplier, 
unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has cha nged. If the latter occu rs, a new evaluation 
is necessary. 
1.1.3.3. Concentration of highly hazardous mixtures  
In the case of the classification of mi xtures covered by sect ions 3.1, 3.2, 3.3, 3.8, 3.9, 
3.10 and 4.1, if a tested mixture is classifi ed in the highest hazard category or sub-
category, and the concentration of the compone nts of the tested mixture that are in 
that category or sub-category is increased, the resulting untested  mixture shall be 
classified in that category or s ub-category without additional testing. 
1.1.3.4 Interpolation within one toxicity category  
In the case of the classification of mi xtures covered by sect ions 3.1, 3.2, 3.3, 3.8, 3.9, 
3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and ar e in the same hazard category, and where 
untested mixture C has the same hazardous components as mixture A and B but has 
concentrations of those hazardous components intermediate to the concentrations in 
mixtures A and B, then mixture C is assume d to be in the same hazard category as A 
and B.”; 
(3) In section 1.1.3.5, the last sentence is replaced by the following: 
“If mixture (i) or (ii) is al ready classified in a particul ar hazard class based on test 
data, then the other of the two mixtures sh all be assigned the same hazard category.”;  
(4) Sections 1.2, 1.2.1, 1.2.1.1, 1.2.1.2 and 1.2.1.3 are replaced by the following: 
“1.2. LABELLING  
1.2.1. Dimensions and make-up of the labe l elements required by Article 17 EN 6   EN 1.2.1.1. Hazard pictograms as laid down in Annex V shall have a black symbol 
on a white background with a red frame suffi ciently wide to be clearly visible. 
1.2.1.2. Hazard pictograms shall be in the shap e of a square set at a point. Each 
hazard pictogram shall cover at least one fifteenth  of the surface area of the label 
dedicated to the information required by Article 17 but the minimum area shall not 
be less than 1 cm2. 
1.2.1.3. The dimensions of the label and of each pictogram shall be as follows: 
Table 1.3 
Dimensions of labels and pictograms 
Capacity of the package Dimensions of the label (in 
millimetres) Dimensions of each 
pictogram (in millimetres) 
Not exceeding 3 litres: If possible, at least 52 x 74 Not smaller than 10 x 10 
If possible, at least 16 x 16  
Greater than 3 litres but, not exceeding 50 litres: At least 74 x 105 At least 23 x 23 
Greater than 50 litres but 
not exceeding 500 litres: At least 105 x 148 At least 32 x 32 
Greater than 500 litres: At least 148 x 210 At least 46 x 46 
”; 
(5) In section 1.5.2.2, point (b) is replaced by the following: 
“(b) The classification of the contents of the soluble packaging is exclusively one or 
more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and”. EN 7   EN B. Part 2 of Annex I to Regulation (E C) No 1272/2008 is amended as follows: 
(1) Section 2.1.4.1 is amended as follows: 
(a) The footnote under Figure 2.1.1 is  replaced by the following: 
“(*) see UN Recommendations on the Transport of Dangerous Goods, Model 
Regulations, 16th rev. ed, sub-section 2.1.2”; 
(b) Figure 2.1.3 is replaced by the following: EN 8   EN "Figure 2.1.3 
Procedure for assignment to a division in th e class of explosives (Class 1 for transport) 
 
No 
No ARTICLE OR SUBSTANCE PROVISIONALLY ACCEPTED IN THIS CLASS (from 
figure 2.1.2)  
Yes 
TEST SERIES 5 Yes
YesNo 
No 
No 
No  
Is the article a candidate 
for Division 1.6? 
 
TEST SERIES 7 
Is it an 
extremely insensitive  
article? Is the 
substance a candidate 
for Division 1.5? 
Is it a 
very insensitive 
explosive substance with 
a mass explosion 
hazard? Package the 
substanceTEST SERIES 6 
Is the 
result a mass 
explosion? 
Is the 
major hazard that 
from dangerous 
projections? 
Is 
the major 
hazard radiant heat 
and/or violent burning 
but with no dangerous blast or 
projection hazard? 
Would 
the hazard hinder 
fire-fighting in the 
immediate 
vicinity? 
Are there 
hazardous effects 
outside the 
package? 
Is the 
substance or article 
 manufactured with the view of 
  producing a practical explosive 
or pyrotechnic 
effect? 
Is the 
product an article 
excluded by definition? 
(see 2.1.1.2 (b)) 
NOT AN 
EXPLOSIVE DIVISION
1.6 DIVISION 
1.5 DIVISION 1.4 
Compatibility 
group S DIVISION 1.4 
Compatibility groups other 
than S DIVISION
1.3 DIVISION 
1.2 DIVISION
1.1 Yes 
YesYesYes Yes 
No 
No 
Yes Yes Yes No 
No No 
 
"; EN 9   EN (c) Figure 2.1.4, is replaced by the following: 
"Figure 2.1.4  
Procedure for the classification of ammonium  nitrate emulsion, susp ension or gel (ANE) 
 
TEST 8 (b) 
ANE Large scale gap test Is the 
substance/mixture too  sensitive to 
shock to be accepted as an oxidising 
liquid or an oxidising solid? TEST SERIES 8 
TEST 8(a)  
Thermal stability test. Is the 
substance/mixture thermally 
stable ? 
TEST 8 (c) 
Koenen test  
Is the substance/mixture too  
sensitive to the effect of intensive 
heat under confinement? 
ANE substance/mixture shall be classified as a 
Category 2 oxidising liquid or a Category 2 
oxidising solid (sections 2.13 and 2.14) No Yes 
No Classify as unstable explosive 
Substance/mixture to be considered for 
classification as an explosive other than as an 
unstable explosive; 
If the answer to the question “is it a very 
insensitive explosive substance/mixture with 
a mass explosion hazard?” in figure 2.1.3 is 
“no”, the substance/mixture shall be 
classified in Division 1.1  
Substance/mixture to be considered for 
classification as an explosive of Division 1.5, 
proceed with Test Series 5.  
If the answer to the question “is it a very 
insensitive explosive substance/mixture with a 
mass explosion hazard?” in figure 2.1.3 is 
“yes”, the substance/mixture shall be classified 
in Division 1.5; if th e answer is “no” the 
substance/mixture shall be classified in 
Division 1.1 No 
Yes 
Yes 
"; 
(2) In section 2.1.4.2, the Note is replaced by the following: 
“Note EN 10   EN Neither a Series 1 type (a) propagation of de tonation test nor a Seri es 2 type (a) test 
of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic su bstances and mixtures of 
organic substances with a decomposition en ergy of 800 J/g or more, tests 1 (a) and 2 
(a) need not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or 
the ballistic mortar test (F.2) or the BA M Trauzl test (F.3) with initiation by a 
standard No.8 detonator (see Appendix 1 to the UN RTDG, Manual of Tests and 
Criteria) is ‘no’. In this case, the results of  test 1 (a) and 2 (a) are deemed to be ‘-‘.”; 
(3) In section 2.2.2.1, the Note under Table 2.2.1 is replaced by the following: 
“Aerosols shall not be classified as  flammable gases; see section 2.3.”; 
(4) In section 2.3.2.1, the Note is re placed by the following notes:  
“Note 1 
Flammable components do not cover pyroph oric, self-heating or water-reactive 
substances and mixtures because such components are never used as aerosol 
contents.  
Note 2  
Flammable aerosols do not fall additiona lly within the scope of sections 2.2 
(flammable gases), 2.6 (flammable liqui ds) or 2.7 (flammable solids).”; 
(5) In section 2.3.2.2, the following Note is in serted at the end of the paragraph: 
“Note 
Aerosols not submitted to the flammability classification procedures in this section 
shall be classified as flammable aerosols, Category 1.”; 
(6) In section 2.4.2.1, the Note under Table 2.4.1 is replaced by the following: 
“Note 
‘"Gases which cause or contribute to the co mbustion of other material more than air 
does" mean pure gases or gas mixtures w ith an oxidising power greater than 23,5% 
as determined by a method specified in ISO 10156 as amended or 10156-2 as 
amended.”; 
(7) In section 2.5.3, the following Note is inserted under Table 2.5.2: 
“Note: Pictogram GHS04 is not required for gases under pressure where pictogram 
GHS02 or pictogram GHS06 appears.”; 
(8) In section 2.6.2.1 the following Note  is inserted under Table 2.6.1: 
“Note 
Aerosols shall not be classified as  flammable liquids; see section 2.3.”; EN 11   EN (9) Section 2.6.4.2 is amended as follows 
(a)  The first paragraph is replaced by the following:  
“In the case of mixtures (1) contai ning known flammable liquids in defined 
concentrations, although they may contain non-volatile components e.g. 
polymers, additives, the flash point need not be determined experimentally if 
the calculated flash point of the mixt ure, using the method given in 2.6.4.3, is 
at least 5 °C (*) greater than the releva nt classification criterion (23 °C and 60 
°C, respectively) and provided that: 
_____________ (*) If the calculated flash point is less than  5°C greater than the relevant classification 
criterion, the calcula tion method may not be used a nd the flash point should be 
determined experimentally.”; 
”; (b) In point (b), the words “of the mixture” shall be added. 
(10) In section 2.6.4.4, Table 2.6.3, the complete row “British Standard Institute, BS 2000 
Part 170 as amended (identical to EN ISO 13736)” is deleted; 
(11) Section 2.6.4.5 is replaced by the following: 
“Liquids with a flash point of more than 35°C and not more than 60 °C need not be 
classified in Category 3 if negative resu lts have been obtained in the sustained 
combustibility test L.2, Part  III, section 32 of the UN RTDG, Manual of Tests and 
Criteria.”; 
(12) The following new section 2.6.4.6 is inserted:  
“2.6.4.6. Possible test methods for determini ng the initial boiling point of flammable 
liquids are listed in Table 2.6.4. 
Table 2.6.4 
Methods for determining the initial bo iling point of flammable liquids  
EN ISO 3405 as amended 
Petroleum products -- Dete rmination of distillation 
characteristics at atmospheric pressure 
EN ISO 3924 as amended  Petroleum products -- Dete rmination of boiling range 
distribution -- Gas chromatography method European standards:  
EN ISO 4626 as amended  
Volatile organic liquids -- Determination of boiling range of organic solvents used as raw materials  
Regulation (EC) No 440/2008(*) Method A.2 as described in Part A of the Annex to 
Regulation (EC) No 440/2008 
________________ EN 12   EN (*) OJ L 142, 31.5.2008, p. 1.” 
(13) In section 2.7.2.3, the Note under Table 2.7.1 is replaced by the following:  
“Note 1  
The test shall be performed on the substa nce or mixture in its physical form as 
presented. If, for example, for the purposes of  supply or transport, the same chemical 
is to be presented in a physical form different from that which was tested and which is considered likely to materially alter it s performance in a cl assification test, the 
substance shall also be tested in the new form. 
Note 2  
Aerosols shall not be classified as  flammable solids; see section 2.3.”; 
(14) In section 2.8.4.2, Figure 2.8.1, points 7.4, 8.4 and 9.4, the word “No” is replaced by 
“None”; 
(15) Section 2.11.1.2 is replaced by the following: 
“2.11.1.2. Self-heating of a substances or mi xtures is a process where the gradual 
reaction of that substance or mixture with  oxygen (in the air) generates heat. If the 
rate of heat production exceeds the rate of heat loss, then the temperature of the 
substance or mixture will rise which, afte r an induction time, may lead to self-
ignition and combustion.”; 
(16) In section 2.15.4.2, Figure 2.15.1, points 7.4, 8.4 and 9.4, the word “No” is replaced 
by “None”. EN 13   EN C. Part 3 of Annex I to Regulation (E C) No 1272/2008 is amended as follows: 
(1) Section 3.1.2.1 is replaced by the following: 
“3.1.2.1. Substances can be allo cated to one of four toxi city categories based on 
acute toxicity by the oral, dermal or inhala tion route according to the numeric criteria 
shown in Table 3.1.1. Acute toxicity values  are expressed as (approximate) LD50 
(oral, dermal) or LC50 (inha lation) values or as acute toxicity estimates (ATE). 
Explanatory notes are shown following Table 3.1.1. EN 14   EN Table 3.1.1 
Acute toxicity hazard categories and 
acute toxicity estimates (ATE) de fining the respective categories 
Exposure 
Route  Category 1 Category 2 Category 3  Category 4 
Oral (mg/kg  bodyweight) 
See: Note (a)  Note (b) ATE <
 5 5 < ATE <  50 50 < ATE <  300 300 < ATE <  2000
Dermal (mg/kg 
bodyweight) See: Note (a)  Note (b) ATE ≤ 50 50 < ATE <
 200200 < ATE 
< 1000 1000 < ATE 
< 2000 
Gases (ppmV*) 
see: Note (a)  Note (b)  Note (c) ATE <
 100 100 < ATE 
< 500 500 < ATE 
< 2500 2500 < ATE 
< 20000 
Vapours (mg/l) 
see: Note (a)  Note (b)  Note (c)  Note (d) ATE <
 0.5 0.5 < ATE <  2.02.0 < ATE 
< 10.0 10.0 < ATE <  20.0
Dusts and Mists 
(mg/l) 
see: Note (a)  Note (b)  Note (c) ATE <
 0.05 0.05 < ATE 
< 0.5 0.5 < ATE <  1.0 1.0 < ATE <  5.0 
 
Notes  to Table 3.1.1: EN 15   EN (a) The acute toxicity estimate (ATE) for th e classification of a substance is derived 
using the LD50/LC50 where available; 
(b) The acute toxicity estimate (ATE) for the classification of a substance in a mixture is 
derived using: 
– the LD50/LC50 where available, 
– the appropriate conversion value from Tabl e 3.1.2 that relates to the results of a 
range test, or 
– the appropriate conversion value fr om Table 3.1.2 that relates to a 
classification category. 
(c) Generic concentration limits for inhalati on toxicity in the table are based on 4 hour 
testing exposures. Conversion of existing inhalation toxicity data which have been 
generated using a 1 hour expos ure can be carried out by di viding by a factor of 2 for 
gases and vapours and 4 for dusts and mists. 
(d) For some substances the test atmosphere will not just be a vapour but will consist of 
a mixture of liquid and vapour phases. For ot her substances the test atmosphere may 
consist of a vapour which is near the gaseous phase. In these latter cases, 
classification shall be based on ppm V as follows: Category 1 (100 ppmV), 
Category 2 (500 ppmV), Category 3 (2500 ppmV), Category 4 (20000 ppmV). 
The terms “dust”, “mist” and “vapour” are defined as follows: – Dust
: solid particles of a substance or mixt ure suspended in a gas (usually air); 
– Mist: liquid droplets of a substance or mixt ure suspended in a gas (usually air); 
– Vapour : the gaseous form of a substance or mixture released from its liquid or 
solid state. 
Dust is generally formed by mechanical pr ocesses. Mist is generally formed by 
condensation of supersatured vapours or by physical shearing of liquids. Dusts and 
mists generally have sizes ranging fr om less than 1 to about 100 µm. 
__________ 
(*) Gas concentrations are expressed in parts per million per volume (ppmV) 
”; 
(2) Section 3.1.3.2 is replaced by the following: 
“For acute toxicity each route of exposure sh all be considered for the classification of 
mixtures, but only one route of exposure is needed as long as th is route is followed 
(estimated or tested) for a ll components and there is no re levant evidence to suggest 
acute toxicity by multiple routes. When there is relevant evidence of toxicity by multiple routes of exposure, classificati on is to be conducted for all appropriate 
routes of exposure. All available informa tion shall be considered. The pictogram and EN 16   EN signal word used shall reflect the most seve re hazard category and all relevant hazard 
statements shall be used.”; 
(3) In section 3.1.3.3, points (c ) and (d) are added:  
“(c) If the converted acute toxicity point estimates for all components of a mixture 
are within the same categor y, then the mixture should be classified in that 
category. 
(d) When only range data (or acute toxi city hazard category information) are 
available for components in a mixture,  they may be c onverted to point 
estimates in accordance with Table 3.1.2 wh en calculating the classification of 
the new mixture using the formulas in sections 3.1.3.6.1 and 3.1.3.6.2.3. 
(4) Section 3.1.3.5.2 is replaced by the following: 
“3.1.3.5.2. If a tested mixture is  diluted with a diluent th at has an equivalent or 
lower toxicity classification than the least toxic original  components, and which is 
not expected to affect the t oxicity of other components, then the new diluted mixture 
may be classified as equivalent to the original tested mixture. Alternatively, the formula explained in sec tion 3.1.3.6.1 can be applied.”; 
(5) Section 3.1.3.6.1, is amended as follows: 
(a) point (c) is replaced by the following: 
“(c) ignore components if the data avai lable are from a limit dose test (at the 
upper threshold for Category 4 for the appropriate route of exposure as 
provided in Table 3.1.1) and do not show acute toxicity.”; 
(b) The first sentence beneath point  (c) is replaced by the following: 
“Components that fall within the scope of this sectio n are considered to be 
components with a known acute toxicity es timate (ATE). See note (b) to Table 3.1.1 
and section 3.1.3.3 for appropriate application of available data to the equation below, and section 3.1.3.6.2.3.”; 
(6) In section 3.1.3.6.2.1, point (a), the f ootnote is replaced by the following: 
“When mixtures contain components that do not have acute toxi city data for each 
route of exposure, acute toxicity estimate s may be extrapolated  from the available 
data and applied to the appropriate rout es (see section 3.1.3.2). However, competent 
authorities may require testing for a specific route. In those cases, classification shall 
be performed for that route based upon the competent authority's requirement.”; 
(7) Section 3.1.3.6.2.2 is replaced by the following: 
“3.1.3.6.2.2. In the event that a component without any useable information for 
classification is used in a mixture at a concen tration of 1 % or grea ter, it is concluded 
that the mixture cannot be attributed a defi nitive acute toxicity estimate. In this 
situation the mixture shall be classified  based on the known components only, with EN 17   EN the additional statement in the label and the SDS that: ‘x percent of the mixture 
consists of component(s) of unknown toxicity’.”; 
(8) In section 3.1.3.6.2.3, the title of Tabl e 3.1.2 is replaced by the following: 
“Conversion from experimentally obtained acute toxicity range  values (or acute 
toxicity hazard categories) to acute toxici ty point estimates for use in the formulas 
for the classification of mixtures”; 
(9) In section 3.4.1.5 the words “at section 3.4.4.”  are replaced by “i n Annex II, section 
2.8.”; 
(10) In section 3.4.1.6 the word “and” is insert ed after “Respiratory Sensitisation;”; 
(11) Sections from 3.4.2 to 3.4.2.2.4.1 are replaced by the following: 
“3.4.2. Classification criteria for substances  
3.4.2.1. Respiratory sensitisers 
3.4.2.1.1. Hazard categories 3.4.2.1.1.1. Respiratory sensitisers shall be clas sified in Category 1 where data are 
not sufficient for sub-categorisation. 
3.4.2.1.1.2. Where data are sufficient a refi ned evaluation according to 3.4.2.1.1.3 
shall allow the allocation of respiratory sensitisers into sub- category 1A, strong 
sensitisers, or sub-category 1B for other respiratory sensitisers. 
3.4.2.1.1.3. Effects seen in either humans or animals will normally justify 
classification in a weight of evidence approa ch for respiratory sensitisers. Substances 
may be allocated to one of the two sub-ca tegories 1A or 1B using a weight of 
evidence approach in accord ance with the criteria give n in Table 3.4.1 and on the 
basis of reliable and good quality eviden ce from human cases or epidemiological 
studies and/or observations from appropria te studies in experimental animals. 
3.4.2.1.1.4. Substances shall be classified as respiratory sensitisers in accordance 
with the criteria in Table 3.4.1: 
Table 3.4.1  
Hazard category and sub-categories for respiratory sensitisers 
Category Criteria 
 
  Category 1 
 Substances shall be classified as respiratory sensitisers 
(Category 1) 
where data are not sufficient for sub-categorisation  
in accordance with the following criteria: 
 
(a) if there is evidence in humans that the substance can 
lead to specific respiratory hypersensitivity and/or 
 
(b) if there are positive results from an appropriate animal 
test. EN 18   EN Sub-category 1A: Substances showing a high frequency of occurrence in 
humans; or a probability of occurrence of a high 
sensitisation rate in humans base d on animal or other tests*. 
Severity of reaction may also be considered. 
Sub-category 1B: Substances showing a low to moderate frequency of 
occurrence in humans; or a pr obability of occurrence of a 
low to moderate sensitisati on rate in humans based on 
animal or other tests1. Severi ty of reaction may also be 
considered. 
 
3.4.2.1.2. Human evidence 3.4.2.1.2.1. Evidence that a substance can lead to specific respiratory 
hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such 
as rhinitis/conjunctivitis and alveolitis are also consider ed. The condition will have 
the clinical character of an allergic reaction. Howeve r, immunological mechanisms 
do not have to be demonstrated. 
3.4.2.1.2.2. When considering the human eviden ce, it is necessary for a decision on 
classification to take into account, in a ddition to the evidence from the cases: 
(a) the size of the population exposed; (b) the extent of exposure. The use of human data is disc ussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. 
3.4.2.1.2.3. The evidence referred to above could be (a) clinical history and data from a ppropriate lung function tests related to 
exposure to the substance, confirmed by other supportive evidence which may 
include: 
(i) in vivo immunological test  (e.g. skin prick test); 
(ii) in vitro immunological test  (e.g. serological analysis); 
(iii) studies that indicate other specific hypersensitivity reactions where 
immunological mechanisms of action have not  been proven, e.g. repeated low-level 
irritation, pharmacologically mediated effects; 
(iv) a chemical structure related to substances known to cause respiratory 
hypersensitivity; 
(b) data from one or more positive bronchial challenge tests with the substance 
conducted according to accepted guidelines  for the determination of a specific 
hypersensitivity reaction. EN 19   EN 3.4.2.1.2.4. Clinical history shall include both medical and occupational history to 
determine a relationship between exposure to a specific substance and development 
of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset a nd progress of the disease, family history 
and medical history of the pa tient in question. The medical history shall also include 
a note of other allergic or airway di sorders from childhood, and smoking history. 
3.4.2.1.2.5. The results of positive bronchial challenge tests are considered to 
provide sufficient evidence for classificati on on their own. It is however recognised 
that in practice many of the examinations listed above will  already have been carried 
out. 
3.4.2.1.3 Animal studies 3.4.2.1.3.1. Data from appropriate animal studi es** which may be indicative of the 
potential of a substance to cause sens itisation by inhalation in humans*** may 
include: 
(i) measurements of Immunoglobulin E (IgE) and other specific immunological 
parameters in mice; 
(ii) specific pulmonary responses in guinea pigs. 3.4.2.2. Skin sensitisers  
3.4.2.2.1. Hazard categories 3.4.2.2.1.1 Skin sensitisers shall be classifi ed in Category 1 where data are not 
sufficient for sub-categorization.  
3.4.2.2.1.2 Where data are sufficient a refi ned evaluation according to section 
3.4.2.2.1.3 allows the allocation of skin sens itisers into sub-category 1A, strong 
sensitisers, or sub-category 1B for other skin sensitisers. 
3.4.2.2.1.3 Effects seen in either humans or animals will normally justify 
classification in a weight of evidence appr oach for skin sensitisers as described 
in section 3.4.2.2.2. Substances may be allocated to one of  the two sub-categories 1A 
or 1B using a weight of evidence approach  in accordance with th e criteria given in 
Table 3.4.2 and on the basis of reliable a nd good quality evidence from human cases 
or epidemiological studies and/or obser vations from appropriate studies in 
experimental animals according to the guidance values provided in sections 3.4.2.2.2.1 and 3.4.2.2.3.2 for sub-category 1A  and in sections 3.4.2.2.2.2 and 
3.4.2.2.3.3 for sub-category 1B 
Table 3.4.2  
Hazard category and sub-categories for skin sensitisers 
Category Criteria 
 
 Substances shall be classified as skin sensitisers 
(Category 1) where data are not sufficient for sub-categorisation  
in accordance with the following criteria: EN 20   EN Category 1 
 (a) if there is evidence in humans that the substance can 
lead to sensitisation by skin contact in a substantial number of persons, or 
(b) if there are positive results from an appropriate 
animal test (see specific criteria in section 3.4.2.2.4.1). 
Sub-category 1A: Substances showing a high frequency of occurrence in 
humans and/or a high potency in animals can be presumed 
to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered. 
Sub-category 1B: Substances showing a low to moderate frequency of 
occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.  
3.4.2.2.2. Human evidence 
3.4.2.2.2.1 Human evidence for sub-category 1A can include: (a) positive responses at ≤ 500 µg/cm
2 (HRIPT, HMT – induction threshold);  
(b) diagnostic patch test data where ther e is a relatively high and substantial 
incidence of reactions in a defined populati on in relation to relatively low exposure; 
(c) other epidemiological evidence where there is a relatively high and substantial 
incidence of allergic contact  dermatitis in relation to relatively low exposure. 
3.4.2.2.2.2 Human evidence for sub-category 1B can include: (a) positive responses at > 500 µg/cm2 (HRIPT, HMT – induction threshold);  (b) diagnostic patch test data where ther e is a relatively low but substantial 
incidence of reactions in a defined population in relation to relati vely high exposure; 
(c) other epidemiological evidence where there is a relatively low but substantial 
incidence of allergic contact  dermatitis in relation to relatively high exposure. 
The use of human data is disc ussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. 
3.4.2.2..3. Animal studies 3.4.2.2.3.1 For Category 1, when an adjuvant type test method for skin 
sensitisation is used, a res ponse of at least 30% of the animals is considered as 
positive. For a non-adjuvant Guinea pig test method a response of at least 15% of the animals is considered positive. For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Test methods for skin sensitisation are described in th e OECD Guideline 406 (the Guinea Pig 
Maximisation test and the Buehler guinea pig test) and Guideline 429 (Local Lymph EN 21   EN Node Assay). Other methods may be used provided that they are well-validated and 
scientific justification is given. The Mouse Ear Swelling Test (MEST), appears to be a reliable screening test to de tect moderate to strong sensi tisers, and can be used as a 
first stage in the assessment of skin sensitisation potential.  
3.4.2.2.3.2 Animal test results for sub-categor y 1A can include data with values 
indicated in Table 3.4.3 
Table 3.4.3: 
Animal test results for sub-category 1A  
Assay Criteria 
Local lymph node assay EC3 value ≤ 2% 
Guinea pig maximisation 
test ≥ 30% responding at ≤ 0,1% intradermal induction dose or  
≥ 60% responding at > 0,1% to ≤ 1% intradermal induction 
dose 
Buehler assay ≥15% responding at ≤ 0,2% topical induction dose or  
≥ 60% responding at > 0,2% to ≤ 20% topical induction dose 
3.4.2.2.3.3 Animal test results for sub-category 1B can include data with values 
indicated in Table 3.4.4 below: 
Table 3.4.4: 
Animal test results for sub-category 1B  
Assay Criteria 
Local lymph node 
assay EC3 value > 2% 
Guinea pig 
maximisation test ≥ 30% to < 60% responding at > 0,1% to ≤ 1% intradermal 
induction dose or 
≥ 30% responding at > 1% intradermal induction dose 
Buehler assay ≥ 15% to < 60% responding at > 0,2% to ≤ 20% topical induction 
dose or 
≥ 15% responding at > 20 % topical induction dose 
 
3.4.2.2.4 Specific considerations 
3.4.2.2.4.1 For classification of a substance, ev idence should include any or all of 
the following using a weight of evidence approach: 
(a) Positive data from patch testing, normally obtained in more than one 
dermatology clinic; 
(b) Epidemiological studies showing allergic contact dermatitis caused by the 
substance. Situations in which a hi gh proportion of those exposed exhibit 
characteristic symptoms are to be looked at  with special concern, even if the number 
of cases is small; EN 22   EN (c) Positive data from appropriate animal studies; 
(d) Positive data from experimental studies in man (see section 1.3.2.4.7); (e) Well documented episodes of allergic contact dermatitis, normally obtained in 
more than one dermatology clinic; 
(f) Severity of reaction may also be considered. 3.4.2.2.4.2 Evidence from animal studies is usually much more reliable than 
evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of 
the evidence from both sources must be a ssessed in order to resolve the question of 
classification on a case-by-case basis. Norm ally, human data are not generated in 
controlled experiments with volunteers for the purpose of hazard classification but 
rather as part of risk asse ssment to confirm lack of eff ects seen in animal tests. 
Consequently, positive human data on skin  sensitisation are usually derived from 
case-control or other, less de fined studies. Evaluation of human data must therefore 
be carried out with caution as the freque ncy of cases reflect, in addition to the 
inherent properties of the substances, f actors such as the exposure situation, 
bioavailability, individual predisposition and preventive measures taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, cons ideration should be given to the impact 
of vehicle. 
3.4.2.2.4.3 If none of the above mentioned conditions are met, the substance need 
not be classified as a skin sensitiser. However, a combination of two or more 
indicators of skin sensitisation as listed below may alter the decision. This shall be 
considered on a case-by-case basis. 
(a) Isolated episodes of allergic contact dermatitis; (b) Epidemiological studies of limite d power, e.g. where chance, bias or 
confounders have not been ruled out fully with reasona ble confidence; 
(c) Data from animal tests, performed according to existing guidelines, which do 
not meet the criteria for a positive resu lt described in section 3.4.2.2.3, but which are 
sufficiently close to the limit to  be considered significant; 
(d) Positive data from non-standard methods; (e) Positive results from close structural analogues.  3.4.2.2.4.4 Immunological contact urticaria Substances meeting the criteria for classifi cation as respiratory sensitisers may in 
addition cause immunological contact urticar ia. Consideration should be given to 
classifying these substances also as sk in sensitisers. Substances which cause 
immunological contact urticaria without meeting the criteria for respiratory 
sensitisers should also be considered fo r classification as skin sensitisers. EN 23   EN There is no recognized animal model avai lable to identify substances which cause 
immunological contact urticaria . Therefore, classification will normally be based on 
human evidence which will be similar to that for skin sensitisation. 
________ (*) At present, recognised and validated animal models for the testing of respiratory 
hypersensitivity are not available. Under cer tain circumstances, data from animal 
studies may provide valuable informati on in a weight of evidence assessment. 
(**)At present, recognized and validated an imal models for the testing of respiratory 
hypersensitivity are not available. Under cer tain circumstances, data from animal 
studies may provide valuable informati on in a weight of evidence assessment. 
(***)The mechanisms by which substances induce symptoms of asthma are not yet 
fully known. For preventative measures, thes e substances are considered respiratory 
sensitisers. However, if on the basis of th e evidence, it can be demonstrated that 
these substances induce symptoms of as thma by irritation only in people with 
bronchial hyper reactivity, they should not be considered as  respiratory sensitisers. ”; 
(12) In section 3.4.3.3.1 the reference to “Tab le 3.4.3” is replaced by “Table 3.4.5”; 
(13) Section 3.4.3.3.2 is amended as follows: 
(a) the reference to “Table 3.4.1” is replaced by “Table 3.4.5”; 
(b) the reference to “Table 3.4.3” is replaced by “Table 3.4.6”; 
(c) Table 3.4.3 and Notes 1, 2 and 3 are replaced by the following: 
“Table 3.4.5   
Generic concentration limits of components of a mixture classified as  either respiratory 
sensitisers or skin sensitisers that trigger classification of the mixture 
Generic concentration limits  
triggering classification of a mixture as: 
Respiratory sensitiser  
Category 1 Skin sensitiser  
Category 1  
Component classified as: 
Solid/Liquid Gas All physical states 
Respiratory sensitiser 
Category 1 ≥ 1,0 % ≥ 0,2%  
Respiratory sensitiser 
Sub-category 1A ≥ 0,1% ≥ 0,1%  
Respiratory sensitiser 
Sub-category 1B ≥ 1,0% ≥ 0,2%  
Skin sensitiser  
Category 1   ≥ 1,0%  EN 24   EN Generic concentration limits  
triggering classification of a mixture as: 
Respiratory sensitiser  
Category 1 Skin sensitiser  
Category 1  
Component classified as: 
Solid/Liquid Gas All physical states 
Skin sensitiser  
Sub-category 1A   ≥ 0,1%  
Skin sensitiser  
Sub-category 1B   ≥ 1,0%  
”; 
(d) A new Table 3.4.6 is inserted  after the new Table 3.4.5: EN 25   EN  
“Table 3.4.6   
Concentration limits for elicitation of components of a mixture 
Concentration limits for elicitation 
Respiratory sensitiser  
Category 1 Skin sensitiser  
Category 1  
Component classified as: 
Solid/Liquid  Gas All physical states  
Respiratory sensitiser 
Category 1 ≥ 0,1% (Note 1) ≥ 0,1% (Note 1)  
Respiratory sensitiser 
Sub-category 1A ≥ 0,01% (Note 1) ≥ 0,01% (Note 1)  
Respiratory sensitiser 
Sub-category 1B ≥ 0,1% (Note 1) ≥ 0,1% (Note 1)  
Skin sensitiser  
Category 1   ≥ 0,1% (Note 1)  
Skin sensitiser  
Sub-category 1A   ≥ 0,01% (Note 1) 
Skin sensitiser  
Sub-category 1B    
≥ 0,1% (Note 1) 
Note 1: This concentration limit for elicitation is used for the application of the 
special labelling requirements of Annex II section 2.8 to protect already sensitised 
individuals. A SDS is required for the mi xture containing a component above this 
concentration. For sensitising substances w ith specific concentration limit lower than 
0,1%, the concentration limit for elicitation s hould be set at one tenth of the specific 
concentration limit.”; 
(14) Section 3.4.4.1 is replaced by the following: 
“3.4.4.1. Label elements shall be used for substances or mixtures meeting the 
criteria for classification in this haza rd class in accordance with Table 3.4.7 
Table 3.4.7  
Respiratory or skin sensitisation label elements 
Classification  Respiratory sensitisation 
Category 1 and sub-
categories 1A and 1B Skin sensitisation 
Category 1 and sub-categories 
1A and 1B EN 26   EN Classification  Respiratory sensitisation 
Category 1 and sub-
categories 1A and 1B Skin sensitisation 
Category 1 and sub-categories 
1A and 1B 
GHS Pictograms 
  
Signal Word Danger Warning 
Hazard Statement H334: May cause allergy or 
asthma symptoms or breathing difficulties if inhaled H317: May cause an allergic 
skin reaction 
Precautionary Statement Prevention P261 
P285 P261 
P272 P280 
Precautionary Statement Response P304 + P341 
P342+ P311 P302 + P352 
P333 + P313 
P321 P363 
Precautionary Statement Storage   
Precautionary 
Statement Disposal P501 P501 
”; 
(15) In section 3.8.3.4.5, the following se ntence is added at the end: 
“Respiratory tract irritation and narcotic e ffects are to be evaluated separately in 
accordance with the criteria given in s ection 3.8.2.2. When conducting classifications 
for these hazards, the contribution of each component should be considered additive, 
unless there is evidence that the effects are not additive.”; 
(16) In section 3.9.1.2, the words “or mixture” are added after the word “substance”; 
(17) The following section 3.10.1.6.2a. is inserted: 
“3.10.1.6.3 Although the definition of aspi ration in sectio n 3.10.1.2 includes the 
entry of solids into the respiratory system , classification accord ing to point (b) in 
Table 3.10.1 for Category 1 is  intended to apply to liqui d substances and mixtures 
only.”; EN 27   EN D. Part 4 of Annex I to Regulation (EC) No 1272/2008 is replaced by the following text: 
“ 
4. PART 4: ENVIRONMENTAL HAZARDS 
4.1. Hazardous to the aquatic environment 
4.1.1.  Definitions and General Considerations 
4.1.1.1.  Definitions  
(a) 'Acute aquatic toxicity' means the intrinsic property of a substance to be 
injurious to an aquatic organism in a short-term aquatic  exposure to that 
substance. 
(b) 'Acute (short-term ) hazard' means for classificati on purposes the hazard of a 
substance or mixture caused by its acute toxicity to an organism during short-
term aquatic exposure to th at substance or mixture. 
(c) 'Availability of a substance' means the extent to which this substance 
becomes a soluble or disaggregate species . For metal availability, the extent 
to which the metal ion portion of a metal (M°) compound can disaggregate 
from the rest of the compound (molecule). 
(d) 'Bioavailability' or 'biological availa bility' means the extent to which a 
substance is taken up by an organism, a nd distributed to an  area within the 
organism. It is dependent upon physico-chemical properties of the substance, anatomy and physiology of the organism, pharmacokinetics, and route of exposure. Availability is not a prerequisite for bioavailability. 
(e) 'Bioaccumulation' means the net result of uptake, transformation and 
elimination of a substance in an organi sm due to all routes of exposure (i.e. 
air, water, sediment/soil and food). 
(f) 'Bioconcentration' means the net re sult of uptake, transformation and 
elimination of a substance in an or ganism due to waterborne exposure. 
(g) 'Chronic aquatic toxicity' means the intr insic property of a substance to cause 
adverse effects to aquatic organism s during aquatic exposures which are 
determined in relation to the life-cycle of the organism. 
(h) 'Degradation' means the decomposition of organic molecules to smaller 
molecules and eventually to carbon dioxide, water and salts. 
(i) 'ECx' means the effect concentratio n associated with x% response.  
(j) 'Long-term hazard' means for classi fication purposes the hazard of a 
substance or mixture caused by its chronic toxicity following long-term 
exposure in the aquatic environment.  EN 28   EN (k) 'No Observed Effect Concentration ( NOEC)' means the test concentration 
immediately below the lowest tested  concentration with statistically 
significant adverse effect. The NOEC ha s no statistically significant adverse 
effect compared to the control.  
4.1.1.2.  Basic elements  
4.1.1.2.0 Hazardous to the Aquatic Envir onment is differentiated into: 
– Acute aquatic hazard; 
– Long-term aquatic hazard. 
4.1.1.2.1 The basic elements used for classificatio n for aquatic environmental hazards are: 
– Acute aquatic toxicity; 
– Chronic aquatic toxicity; 
– Potential for or actual bioaccumulation; and 
– Degradation (biotic or abiotic) for organic chemicals 
4.1.1.2.2 Preferably data shall be derived using the standardised test methods referred to in 
Article 8(3). In practice data from other st andardised test methods such as national 
methods shall also be used where they are considered as equivalent. Where valid data 
are available from non-standard testing a nd from non-testing methods, these shall be 
considered in classification provided they fulfil the requirements specified in section 1 of Annex XI to Regulation (EC) No 1907/2006. In general, both freshwater and 
marine species toxicity data are considered  suitable for use in classification provided 
the test methods used are equivalent. Where such data are not available classification 
shall be based on the best available data. See also Part 1.  
4.1.1.3.  Other considerations  
4.1.1.3.1 Classification of substances and mixtur es for environmental hazards requires the 
identification of the hazards they present to the aquatic environment. The aquatic 
environment is considered in terms of the aquatic organisms that live in the water, 
and the aquatic ecosystem of which they are part. The basis, therefore, of the 
identification of acute (short-term) and long- term hazards is the aquatic toxicity of 
the substance or mixture, although this sha ll be modified by taking account of further 
information on the degradation and bioaccumulation behaviour, if appropriate. 
4.1.1.3.2 While the classification system applies to all substances and mixtures, it is 
recognised that for special cases the Eu ropean Chemicals Agency has issued 
guidance. 
4.1.2.  Classification criteria for substances 
4.1.2.1. The system for classification recognises that  the intrinsic hazard to aquatic organisms 
is represented by both the acute and long-term  hazard of a substance. Separate hazard 
categories are defined for both properties representing a gradation in the level of EN 29   EN hazard identified. The lowest of the availabl e toxicity values be tween and within the 
different trophic levels (fish, crustacean, algae/aquatic plan ts) shall normally be used 
to define the appropriate hazard category( ies). There are circumstances, however, 
when a weight of evidence approach is appropriate. 
4.1.2.2. The core classification system for subs tances consists of one acute hazard 
classification category and three long-term hazard classification categories. The acute 
and the long-term hazard classification categories are applied independently.  
4.1.2.3. The criteria for classifica tion of a substance in categor y Acute 1 are defined on the 
basis of acute aquatic toxicity data only (EC50 or LC50). The criteria for 
classification of a substance into the categories Chronic 1 to 3 follow a tiered 
approach where the first step is to see if  available information on chronic toxicity 
merits long-term hazard classification. In ab sence of adequate chronic toxicity data, 
the subsequent step is to combine two types of information, i.e. acute aquatic toxicity 
data and environmental fate  data (degradability and bioaccumulation data) (see 
figure 4.1.1).  
Figure 4.1.1 
Categories for substances long-term ha zardous to the aquatic environment 
 
Classify according to the criteria given in Table 4.1.0(b) (iii)  Are there  
adequate acute  
toxicity data  
available? 
 Are there  
adequate chronic  
toxicity data available  
for one or two  
trophic levels?  Classify according to the criteria given in Table 4.1.0(b) (i) 
or 4.1.0(b)(ii) depending on information on rapid degradation 
Assess both: 
(a) according to the criteria given in Table 4.1.0(b)(i) or 4.1.0(b)(ii) 
(depending on information on rapid degradation), and 
(b) (if for the other trophic level(s) adequate acute toxicity data are 
available) according to the criteria given in Table 4.1.0(b) (iii), 
and classify according to the most stringent outcome Are there  
adequate chronic  
toxicity data available  
for all three trophic levels?  
 
 Yes 
Yes 
Yes No 
No EN 30   EN 4.1.2.4. The system also introduces a "safety net" classification (referred to as 
category Chronic 4) for use when the data available do not allow classification under 
the formal criteria for acute 1 or chroni c 1 to 3 but there are nevertheless some 
grounds for concern (see example in Table 4.1.0). 
4.1.2.5. Substances with acute toxicities below 1 mg/l or chronic toxici ties below 0.1 mg/l (if 
non-rapidly degradable) and 0.01 mg/l (if rapidly degradable) contribute as 
components of a mixture to the toxicity of  the mixture even at a low concentration 
and shall normally be given increased weight in applying the summation of classification approach (see note 1 of Table 4.1.0 and section 4.1.3.5.5). 
4.1.2.6. The criteria for classifying and categoris ing substances as "hazardous to the aquatic 
environment" are summarised in Table 4.1.0. 
Table 4.1.0   
Classification categories for haza rdous to the aquatic environment 
 
(a) Acute (short-term) aquatic hazard 
Category Acute 1
: (Note 1) 
96 hr LC 50 (for fish) ≤1 mg/l and/or 
48 hr EC 50 (for crustacea) ≤1 mg/l and/or 
72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤1 mg/l. (Note 2) 
(b) Long-term aquatic hazard 
(i) Non-rapidly degradable substances (Not e 3) for which there are adequate chronic 
toxicity data available   
Category Chronic 1:  (Note 1) 
Chronic NOEC or EC x (for fish) ≤0.1 mg/l and/or 
Chronic NOEC or EC x (for crustacea) ≤0.1 mg/l and/or 
Chronic NOEC or EC x (for algae or other aquatic plants) ≤0.1 mg/l.  
Category Chronic 2:  
Chronic NOEC or EC x (for fish) ≤1 mg/l and/or 
Chronic NOEC or EC x (for crustacea) ≤1 mg/l and/or 
Chronic NOEC or EC x (for algae or other aquatic plants) ≤1 mg/l. 
(ii) Rapidly degradable substa nces (Note 3) for which there are adequate chronic toxicity 
data available  EN 31   EN Category Chronic 1: (Note 1) 
Chronic NOEC or EC x (for fish) ≤0.01 mg/l and/or 
Chronic NOEC or EC x (for crustacea) ≤0.01 mg/l and/or 
Chronic NOEC or EC x (for algae or other aquatic plants) ≤0.01 mg/l.  
Category Chronic 2:  
Chronic NOEC or EC x (for fish) ≤0.1 mg/l and/or 
Chronic NOEC or EC x (for crustacea) ≤0.1 mg/l and/or 
Chronic NOEC or EC x (for algae or other aquatic plants) ≤0.1 mg/l. 
Category Chronic 3:  
Chronic NOEC or EC x (for fish) ≤1 mg/l and/or 
Chronic NOEC or EC x (for crustacea) ≤1 mg/l and/or 
Chronic NOEC or EC x (for algae or other aquatic plants) ≤1 mg/l. 
(iii) Substances for which adequate ch ronic toxicity data are not available  
Category Chronic 1: (Note 1) 
96 hr LC 50 (for fish) ≤1 mg/l and/or 
48 hr EC 50 (for crustacea) ≤1 mg/l and/or 
72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤1 mg/l. (Note 2) 
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 
(or, if absent, the log K ow ≥ 4). (Note 3). 
Category Chronic 2:  
96 hr LC 50 (for fish) >1 to ≤10 mg/l and/or 
48 hr EC 50 (for crustacea) >1 to ≤10 mg/l and/or 
72 or 96 hr ErC 50 (for algae or other aquatic plants) >1 to ≤10 mg/l (Note 2) 
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 
(or, if absent, the log K ow ≥ 4). (Note 3). 
Category Chronic 3:  EN 32   EN 96 hr LC 50 (for fish) > 10 to ≤ 100 mg/l and/or 
48 hr EC 50 (for crustacea) > 10 to ≤ 100 mg/l and/or 
72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l.
 (Note 2) 
and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 
(or, if absent, the log K ow ≥ 4). (Note 3). EN 33   EN "Safety net" classification 
Category Chronic 4  
Cases when data do not allow classification under the above criteria but there are nevertheless 
some grounds for concern. This includes, for ex ample, poorly soluble substances for which no 
acute toxicity is recorded at levels up to the water solubility (note 4), and which are not 
rapidly degradable in accordance with se ction 4.1.2.9.5 and have an experimentally 
determined BCF ≥ 500 (or, if absent, a log K ow ≥ 4), indicating a potenti al to bioaccumulate, 
which will be classified in this category unl ess other scientific evidence exists showing 
classification to be unnecessary. Such eviden ce includes chronic toxi city NOECs > water 
solubility or > 1 mg/l, or othe r evidence of rapid degradation in  the environment than the ones 
provided by any of the methods  listed in section 4.1.2.9.5. 
Note 1 
When classifying substances as Acute Category 1 and/or Chronic Category 1 it is necessary at 
the same time to indicate the appropriate M-factor(s)  (see Table 4.1.3). 
Note 2 
Classification shall be based on the ErC 50 [= EC 50 (growth rate)]. In circumstances where the 
basis of the EC 50 is not specified or no ErC 50 is recorded, classification shall be based on the 
lowest EC 50 available. 
Note 3 
When no useful data on degradability are ava ilable, either experimentally determined or 
estimated data, the substance should be regarded as not rapidly degradable. 
Note 4 
"No acute toxicity" is taken to mean that the L(E)C 50(s) is/are above the water solubility. Also 
for poorly soluble substances, (water solubility < 1 mg/l), where there is evidence that the 
acute test does not provide a true measure of the intrinsic toxicity. 
4.1.2.7 Aquatic toxicity  
4.1.2.7.1 Acute aquatic toxicity is normally determined using a fish 96 hour LC50, a crustacea 
species 48 hour EC50 and/or an algal sp ecies 72 or 96 hour EC50. These species 
cover a range of trophic leve ls and taxa and are consid ered as surrogate for all 
aquatic organisms. Data on other species (e.g. Lemna spp.) shall also be considered if 
the test methodology is suitable. The aqua tic plant growth inhibition tests are 
normally considered as chronic tests but th e EC50s are treated as acute values for 
classification purposes (see note 2). 
4.1.2.7.2 For determining chronic aquatic toxicity for classification purposes data generated 
according to the standardised test methods  referred to in Article 8(3) shall be 
accepted, as well as results obtained from  other validated and internationally 
accepted test methods. The NOECs or other equivalent ECx (e.g. EC10) shall be used. EN 34   EN 4.1.2.8 Bioaccumulation  
4.1.2.8.1 Bioaccumulation of substances within a quatic organisms can gi ve rise to toxic 
effects over longer time scales even when actual water concentra tions are low. For 
organic substances the potential for bio accumulation shall normally be determined 
by using the octanol/water partition coefficien t, usually reported as a log Kow. The 
relationship between the log Ko w of an organic substance and its bioconcentration as 
measured by the bioconcentration factor ( BCF) in fish has considerable scientific 
literature support. Using a cut-off value of log Kow ≥ 4 is intended to identify only 
those substances with a real potential to  bioconcentrate. While this represents a 
potential to bioaccumulate, an experiment ally determined BCF provides a better 
measure and shall be used in preferen ce if available. A BCF in fish of ≥ 500 is 
indicative of the potential to bioconcentr ate for classification purposes. Some 
relationships can be observed between chronic toxicity and bioaccumulation 
potential, as toxicity is related to the body burden. 
4.1.2.9 Rapid degradability of organic substances  
4.1.2.9.1 Substances that rapidly degrade can be  quickly removed from the environment. 
While effects of such substances can occur, particularly in the event of a spillage or accident, they are localised and of short durat ion. In the absence of rapid degradation 
in the environment a substance in the water has the potential to exert toxicity over a 
wide temporal and spatial scale. 
4.1.2.9.2 One way of demonstrating rapid degrada tion utilises the biode gradation screening 
tests designed to determine whether an or ganic substance is "r eadily biodegradable". 
Where such data are not available, a BOD(5 days)/COD ratio ≥ 0,5 is considered as 
indicative of rapid degradation. Thus, a substa nce which passes this screening test is 
considered likely to biodegrade "rapidly" in the aquatic environment, and is thus 
unlikely to be persistent. However, a fail in the screening test does not necessarily mean that the substance will not degrade ra pidly in the environment. Other evidence 
of rapid degradation in the environment may therefore also be considered and are of 
particular importance where the substances are inhibitory to microbial activity at the 
concentration levels used in standard tes ting. Thus, a further classification criterion is 
included which allows the use of data to s how that the s ubstance did actually degrade 
biotically or abiotically in the aquatic environment by > 70 % in 28 days. Thus, if 
degradation is demonstrated under envir onmentally realistic conditions, then the 
criterion of "rapid degradability" is met. 
4.1.2.9.3 Many degradation data are available in the form of degradation half-lives and these 
can be used in defining rapid degradati on provided that ultimate biodegradation of 
the substance, i.e. full mineralisation, is  achieved. Primary biodegradation does not 
normally suffice in the assessment of rapid degradability unless it can be demonstrated that the degradation products do  not fulfil the criteria for classification 
as hazardous to the aquatic environment. 
4.1.2.9.4 The criteria used reflect th e fact that environmental de gradation may be biotic or 
abiotic. Hydrolysis can be considered if the hydrolysis products do not fulfil the 
criteria for classification as haza rdous to the aquatic environment. 
4.1.2.9.5 Substances are considered rapidly degrad able in the environment if one of the EN 35   EN following criteria holds true: 
(a) if, in 28-day ready biodegradation st udies, at least the following levels of 
degradation are achieved: 
(i) tests based on dissolv ed organic carbon: 70 %; 
(ii) tests based on oxygen depletion or  carbon dioxide generation: 60 % of 
theoretical maximum. 
These levels of biodegradation must be achieved within 10 days  of the start of 
degradation which point is taken as the ti me when 10 % of the substance has been 
degraded, unless the substance is identified as an UVCB or as a complex, multi-constituent substance with structurally si milar constituents. In this case, and where 
there is sufficient justifica tion, the 10-day window condi tion may be waived and the 
pass level applied at 28 days, or 
(b) if, in those cases where only BOD a nd COD data are available, when the 
ratio of BOD5/COD is ≥ 0,5; or 
(c) if other convincing scientific evidence is available to demonstrate that the 
substance can be degraded (biotically and/or abiotically) in the aquatic environment to a level > 70 % within a 28-day period. 
4.1.2.10 Inorganic compounds and metals 
4.1.2.10.1 For inorganic compounds and metals, the co ncept of degradabili ty as applied to 
organic compounds has limited or no meaning. Rather, such substances may be transformed by normal environmental processe s to either increase or decrease the 
bioavailability of the toxic species. Equally the use of bioaccumul ation data shall be 
treated with care*. 
4.1.2.10.2 Poorly soluble inorganic compounds and metals may be acute ly or chronically 
toxic in the aquatic environment dependi ng on the intrinsic toxicity of the 
bioavailable inorganic species  and the rate and amount of  this species which enter 
solution. All evidence must be weighed in a classification decision. This would be 
especially true for metals showing borderline results in the 
Transformation/Dissolution Protocol. 
4.1.3.  Classification criteria for mixtures 
4.1.3.1. The classification system for mixtures co vers all classificati on categories which are 
used for used for substances, i.e. categories Acute 1 and Ch ronic 1 to 4. In order to 
make use of all available data for purposes  of classifying the aquatic environmental 
hazards of the mixture, the following is applied where appropriate:  The "relevant components" of a mixture are those which are classified "Acute 1"or 
"Chronic 1" and present in a concentration of 0,1 % (w /w) or greater, and those 
which are classified "Chroni c 2", "Chronic 3" or "Chr onic 4" and present in a 
concentration of 1 % (w/w) or greater, unles s there is a presumption (such as in the 
case of highly toxic com ponents (see section 4.1.3.5.5.5)) th at a component present 
in a lower concentration can still be relevant for classifying the mixture for aquatic EN 36   EN environmental hazards. Generally, for substanc es classified as "Acute 1" or "Chronic 
1" the concentration to be taken into account  is (0,1/M) %. (For explanation M-factor 
see section 4.1.3.5.5.5). 
4.1.3.2. The approach for classification of aquati c environmental hazards is tiered, and is 
dependent upon the type of information av ailable for the mixture itself and for its 
components. Figure 4.1.2 outlines the process to be followed. 
Elements of the tiered approach include: – classification based on tested mixtures; 
– classification based on bridging principles; 
– the use of "summation of classified com ponents" and/or an "additivity formula. 
_________ (*) Specific guidance has been issued by the Ag ency on how these data for such substances 
may be used in meeting the requireme nts of the classification criteria.". EN 37   EN Figure 4.1.2  
Tiered approach to classification of mixtures 
for acute and long-term aqua tic environmental hazards 
 
4.1.3.3. Classification of mixtures when toxicity data are available for the complete mixture  
4.1.3.3.1 When the mixture as a whole has been test ed to determine its a quatic toxicity, this 
information can be used for classifying the mixture according to the criteria that have 
been agreed for substances. The classifica tion is normally based on the data for fish, 
crustacea and algae/plants (see sec tions 4.1.2.7.1 and 4.1.2.7.2). When adequate 
acute or chronic toxicity data for the mixture as a whole are lacking, “bridging principles” or “summation method” s hould be applied (see sections 4.1.3.4 and 
4.1.3.5). 
4.1.3.3.2 The long-term hazard classification of mi xtures requires additional information on 
degradability and in certain cases  bioaccumulation. Degradability and 
bioaccumulation tests for mixtures are not used as they are usually difficult to 
interpret, and such tests may be me aningful only for single substances. 
4.1.3.3.3 Classification fo r category Acute 1 Aquatic toxicity test data available on the mixture as a whole
Sufficient data available on 
similar mixtures to estimate hazardsYes No 
Yes 
Apply bridging principles
(see 4.1.3.4.)CLASSIFY
for acute/long-term aquatic hazard 
(see 4.1.3.3)
CLASSIFY
for acute/long-term aquatic hazard 
 No
Either aquatic toxicity o r 
classification data 
available for all relevant 
componentsYes Apply summation Method (see 
4.1.3.5.5) using:
• Percentage of all 
  components classified as  "Chronic"
• Percentage o
f 
 components classified as 
  "Acute"
• Percentage of components with 
 acute or chronic toxicity data: apply  addititivity formulas (see 
  4.1.3.5.2) and convert the
  derived L(E)C
50or EqNOECm 
to the appropriate "Acute"    o r 
"Chronic" Category CLASSIFY
for acute/long-term aquatic hazard 
 
Use available hazard data 
of known components.No
Apply Summation Method and/o r 
Additivity Formula (see 4.1.3.5) 
and apply 4.1.3.6CLASSIFY  
for acute/long-term aquatic hazard 
 EN 38   EN (a) When there are adequate acu te toxicity test data (LC 50 or EC 50) available for 
the mixture as a whole showing L(E)C 50 ≤ 1 mg/l: 
Classify mixture as Acute 1 in accordance with point (a) of Table 4.1.0. 
(b) When there are acute toxicity test da ta (LC50(s) or EC50(s)) available for the 
mixture as a whole showing L(E)C50(s) >1 mg/l for normally all trophic 
levels: 
No need to classify for acute hazard. 
4.1.3.3.4 Classification for cate gories Chronic 1, 2 and 3 
(a) When there are adequate chronic toxic ity data (ECx or NOEC) available for the 
mixture as a whole showing ECx or NOEC of the tested mixture ≤ 1mg/l: 
(i) Classify the mixture as Chronic 1, 2 or 3 in accordance with point (b)(ii) 
of Table 4.1.0. as rapidly degradable if  the available information allows 
the conclusion that all relevant co mponents of the mixture are rapidly 
degradable;  
(ii) Classify the mixture as Chronic 1, 2 or 3 in all other cases in accordance 
with point (b)(i) of Table 4.1.0. as non-rapidly degradable; 
(b) When there are adequate chronic toxic ity data (ECx or NOEC) available for the 
mixture as a whole showing ECx(s) or NOEC(s) of the tested mixture > 1 mg/l 
for normally all trophic levels:  
No need to classify for long-term hazard in categories Chronic 1, 2 or 3. 
4.1.3.3.5 Classification for category Chronic 4 
If there are nevertheless reasons for concern: Classify the mixture as Chr onic 4 (safety net classificati on) in accordance with Table 
4.1.0. 
4.1.3.4. Classification of mixtures when toxicity  data are not available for the complete 
mixture: Bridging principles  
4.1.3.4.1 Where the mixture itself has not been test ed to determine its aquatic environmental 
hazard, but there are sufficient data on the individual components and similar tested mixtures to adequately characte rise the hazards of the mixtur e, this data shall be used 
in accordance with the bridging rules set out  in section 4.1.3. However, in relation to 
application of the bridging rule for d ilution, sections 4.1.3.4.2 and 4.1.3.4.3 shall be 
used. 
4.1.3.4.2 Dilution: if a mixture is formed by dilu ting another tested mixture or a substance 
classified for its aquatic environmental haza rd with a diluent whic h has an equivalent 
or lower aquatic hazard clas sification than the least to xic original component and 
which is not expected to affect the aqua tic hazards of other components, then the 
resulting mixture may be classified as equi valent to the original tested mixture or EN 39   EN substance. Alternatively, the method expl ained in section 4.1.3.5 may be applied. 
4.1.3.4.3 If a mixture is formed by d iluting another classified mixture or substance with water 
or other totally non-toxi c material, the toxicity of the mixture can be calculated from 
the original mixture or substance. 
4.1.3.5. Classification of mixtures when toxici ty data are available for some or all 
components of the mixture 
4.1.3.5.1 The classification of a mixture is based on summation of the concentration of its 
classified components. The percentage of  components classified as "Acute" or 
"Chronic" is fed straight in to the su mmation method. Details of the summation 
method are described in section 4.1.3.5.5. 
4.1.3.5.2 Mixtures can be made of a combination of both components that are classified (as 
Acute 1 and/or Chronic 1, 2, 3, 4) and others for which adequate toxicity test data is 
available. When adequate toxicity data ar e available for more th an one component in 
the mixture, the combined toxicity of those components is calculated using the 
following additivity formulas (a) or (b), depe nding on the nature of the toxicity data:  
(a) Based on acute aquatic toxicity: 
∑∑
η=
i50 m50 C)E(LCi  C)E(LCi
 
where: 
Ci = concentration of compone nt i (weight percentage) 
L(E)C 50 i = (mg/l) LC 50 or EC 50 for component i 
η = number of components 
L(E)C 50 m = L(E) C 50 of the part of the mixture with test data 
The calculated toxicity may be used to assi gn that portion of the mixture an acute 
hazard category which is then subsequently  used in applying the summation method; 
(b) Based on chronic aquatic toxicity: 
∑ ∑∑ ∑
×+ =+
n nm NOECj1.0Cj
NOECiCi
EqNOECCj Ci
 
where: 
Ci = concentration of com ponent i (weight percentage ) covering the rapidly 
degradable components; 
Cj = concentration of component j (weight  percentage) coveri ng the non- rapidly 
degradable components; EN 40   EN NOECi = NOEC (or other recognized measures  for chronic toxicity) for component i 
covering the rapidly degradable components, in mg/l; 
NOECj = NOEC (or other recognized measures  for chronic toxicity) for component j 
covering the non-rapidly degradable components, in mg/l; 
n = number of components, and i and j are running from 1 ton; 
EqNOECm = Equivalent NOEC of the part  of the mixture with test data; 
The equivalent toxicity thus reflects the fact that non-rapidly degrading substances 
are classified one hazard category level more “severe” than rapidly degrading substances. 
The calculated equivalent toxicity may be us ed to assign that portion of the mixture a 
long-term hazard category, in accordance with  the criteria for rapidly degradable 
substances (point (b)(ii) of Table 4.1.0.), which is then s ubsequently used in applying 
the summation method.  EN 41   EN 4.1.3.5.3 When applying the additivity formula for pa rt of the mixture, it is preferable to 
calculate the toxicity of this part of th e mixture using for each substance toxicity 
values that relate to the same taxonomi c group (i.e. fish, crustacean, algae or 
equivalent) and then to use th e highest toxicity (lowest value) obta ined (i.e. use the 
most sensitive of the three taxonomic groups). However, when toxicity data for each component are not available in the same taxonomic group, the toxicity value of each 
component is selected in the same manner th at toxicity values are selected for the 
classification of substances, i.e. the highe r toxicity (from the most sensitive test 
organism) is used. The calculated acute and chronic toxicity is then used to assess 
whether this part of the mixt ure shall be classified as Ac ute 1 and/or Chronic 1, 2 or 
3 using the same criteria described for substances. 
4.1.3.5.4 If a mixture is classified in more th an one way, the method yielding the more 
conservative result shall be used 
4.1.3.5.5 Summation method 4.1.3.5.6 Rationale 4.1.3.5.5.1.1. In case of the substance classificati on categories Chronic 1 to Chronic 3, the 
underlying toxicity criteria differ by a fact or of 10 in moving from one category to 
another. Substances with a classification in  a high toxicity band therefore contribute 
to the classification of a mixture in a lower band. The calculation of these 
classification categories theref ore needs to consider the contribution of any substance 
classified as Chronic 1, 2 or 3. 
4.1.3.5.5.1.2. When a mixture contains components cl assified as Acute 1 or Chronic 1, 
attention must be paid to th e fact that such components, when their acute toxicity is 
below 1 mg/l and/or chronic toxicity is  below 0.1 mg/l (if non rapidly degradable) 
and 0.01 mg/l (if rapidly degradable) contribute to the toxicity of the mixture even at 
a low concentration. Active ingredients in pesticides often possess such high aquatic 
toxicity but also some other substances  like organometallic compounds. Under these 
circumstances the application of the normal generic concentration limits leads to an 
"under-classification" of the mixture. Ther efore, multiplying factors shall be applied 
to account for highly toxic componen ts, as described in section 4.1.3.5.5.5. 
4.1.3.5.5.2. Classification procedure 4.1.3.5.5.2.1. In general a more severe classificat ion for mixtures overrides a less severe 
classification, e.g. a classifi cation with Chronic 1 overrid es a classification with 
Chronic 2. As a consequence, in this exampl e, the classification procedure is already 
completed if the result of the classificati on is Chronic 1. A more severe classification 
than Chronic 1 is not possible. Therefore it is not necessary to undergo the further 
classification procedure. 
4.1.3.5.5.3. Classification for category Acute 1 4.1.3.5.5.3.1. First all components classi fied as Acute 1 are considered. If the sum of the 
concentrations (in %) of these com ponents multiplied by their corresponding M-
factors is greater than 25 % the whole mixture is classified as Acute 1. EN 42   EN 4.1.3.5.5.3.2. The classification of mixtures for acu te hazards based on this summation of 
classified components is summarised in Table 4.1.1. 
Table 4.1.1  
Classification of a mixture for acute hazards, 
based on summation of classified components 
Sum of components classified as : Mixture is classified as: 
Acute 1 x Ma ≥ 25 % Acute 1 
a For explanation of the M-factor, see 4.1.3.5.5.5 
4.1.3.5.5.4. Classification for the cate gories Chronic 1, 2, 3 and 4 
4.1.3.5.5.4.1. First all components classi fied as Chronic 1 are cons idered. If the sum of the 
concentrations (in %) of these com ponents multiplied by their corresponding M-
factors is equal to or greater than 25 % the mixture is classified as Chronic 1. If the 
result of the calculation is a classification of the mixture as Chronic 1 the classification procedure is completed. 
4.1.3.5.5.4.2. In cases where the mixture is not classi fied as Chronic 1, classification of the 
mixture as Chronic 2 is considered. A mixtur e is classified as Chronic 2 if 10 times 
the sum of the concentrati ons (in %) of all components classified as Chronic 1 
multiplied by their corresponding M-factors pl us the sum of the concentrations (in 
%) of all components classified as Chronic 2 is equal to or  greater than 25 %. If the 
result of the calculation is classification of the mixture as Chronic 2, the classification process is completed. 
4.1.3.5.5.4.3. In cases where the mixture is not classi fied either as Chro nic 1 or Chronic 2, 
classification of the mixture as Chronic 3 is considered. A mixture is classified as 
Chronic 3 if 100 times the sum of the c oncentrations (in %) of all components 
classified as Chronic 1 multiplied by their corresponding M-factors plus 10 times the sum of the concentrations (in %) of all com ponents classified with Chronic 2 plus the 
sum of the concentrations (in %) of a ll components classified as Chronic 3 is ≥ 25 %. 
4.1.3.5.5.4.4. If the mixture is still no t classified in Chronic 1, 2 or 3, classification of the 
mixture as Chronic 4 shall be considered. A mixture is classified as Chronic 4 if the 
sum of the concentrations (in %) of compone nts classified as Chronic 1, 2, 3 and 4 is 
equal to or greater than 25 %. EN 43   EN 4.1.3.5.5.4.5. The classification of mixtures for -lo ng-term hazards, based on this summation 
of the concentrations of classified components, is summarised in Table 4.1.2. 
Table 4.1.2  
Classification of a mixture for long-term hazards, 
based on summation of the concentr ations of classified components 
Sum of components classified as : Mixture is classified as: 
Chronic 1 x Ma ≥ 25 % Chronic 1 
(M x 10 x Chronic 1) + Chronic 2 ≥ 25 % Chronic 2 
(M x 100 x Chronic 1) + (10 x Chronic 2) 
+ Chronic 3 ≥ 25 % Chronic 3 
Chronic 1 + Chronic 2 + Chronic 3 
+ Chronic 4 ≥ 25 % Chronic 4 
a For explanation of the M-factor, see 4.1.3.5.5.5 
4.1.3.5.5.5. Mixtures with highly toxic components 4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg /l and/or chronic 
toxicities below 0.1 mg/l (if non-rapidly degradable) and 0.01 mg/l (if rapidly 
degradable) contribute to the toxicity of th e mixture even at a low concentration and 
shall normally be given increased weight in  applying the summation of classification 
approach. When a mixture contains compone nts classified as Ac ute or Chronic 1, 
one of the following shall be applied: 
– The tiered approach described in  sections 4.1.3.5.5.3 and 4.1.3.5.5.4 using a 
weighted sum by multiplying the concen trations of Acute 1 and Chronic 1 
components by a factor, instead of mere ly adding up the percentages. This 
means that the concentration of "Acute 1" in the left column of Table 4.1.1 and 
the concentration of "Chronic 1" in the left column of Table 4.1.2 are multiplied by the appropriate multiplying factor. The multiplying factors to be applied to these components are defi ned using the toxicity value, as 
summarised in Table 4.1.3. Therefore, in order to classify a mixture containing 
Acute/Chronic 1 components, the classifier  needs to be info rmed of the value 
of the M-factor in order to  apply the summation method; 
– The additivity formula (see section 4.1.3.5.2)  provided that toxicity data are 
available for all highly toxic components in the mixture and there is convincing 
evidence that all other components, in cluding those for which specific acute 
and/or chronic toxicity data  are not available, are of low or no toxi city and do 
not significantly contribute to the environmental hazard of the mixture. EN 44   EN Table 4.1.3  
Multiplying factors for highly toxic components of mixtures 
 
Acute toxicity M factor Ch ronic toxicity M factor 
L(E)C 50 value  NOEC value NRDa 
components RDb 
components 
0,1 < L(E)C 50 ≤ 1 1 0,01 < NOEC ≤ 0,1 1 - 
0,01 < L(E)C 50 ≤ 0,1 10 0,001 < NOEC ≤ 0,01 10 1  
0,001 < L(E)C 50 ≤ 0,01 100 0,0001 < NOEC ≤ 0,001 100 10  
0,0001 < L(E)C 50 ≤ 0,001 1000 0,00001 < NOEC ≤ 0,0001 1000 100  
0,00001 < L(E)C 50 ≤ 0,0001 10000 0,000001 < NOEC ≤ 0,00001 10000 1000  
(continue in factor 10 intervals) (continue in factor 10 intervals)  
a Non-rapidly degradable 
b Rapidly degradable 
4.1.3.6. Classification of mixtures with com ponents without any useable information 
4.1.3.6.1. In the event that no useable informa tion on acute and/or long-term aquatic 
hazard is available for one or more relevant components, it is concluded that the mixture cannot be attributed to one or more  definitive hazard category(ies). In this 
situation the mixture shall be classified  based on the known components only, with 
the additional statement in the label and the SDS that: "Contains x % of components 
with unknown hazards to the aquatic environment". EN 45   EN 4.1.4.  Hazard Communication 
4.1.4.1. Label elements shall be used for substa nces or mixtures m eeting the criteria for 
classification in this hazard cl ass in accordance with Table 4.1.4. 
Table 4.1.4  
Label elements for hazardous to the aquatic environment 
 
ACUTE AQUATIC HAZARD 
 Acute1 
GHS Pictogram 
 
Signal Word Warning 
Hazard Statement H400: Very toxic to 
aquatic life 
Precautionary Statement Prevention P273 
Precautionary 
Statement 
Response P391 
Precautionary 
Statement Storage  
Precautionary 
Statement Disposal P501 
 EN 46   EN LONG-TERM AQUATIC HAZARD 
 Chronic 1 Chronic 2 Chronic 3 Chronic 4 
GHS Pictograms 
 
  No pictogram is 
used No pictogram is 
used 
Signal Word Warning No signal word 
is used No signal word is 
used No signal word is 
used 
Hazard Statement H410: Very toxic 
to aquatic life 
with long lasting 
effects H411: Toxic to 
aquatic life with 
long lasting 
effects H412: Harmful to 
aquatic life with 
long lasting 
effects H413: May cause 
long lasting 
harmful effects to 
aquatic life 
Precautionary  
Statement  
Prevention P273 P273 P273 P273 
Precautionary 
Statement 
Response P391 P391   
Precautionary 
Statement 
Storage     
Precautionary 
Statement Disposal P501 P501 P501 P501 
” EN 47   EN E. Part 5 of Annex I to Regulation (EC) No 1272/2008 is replaced by the following text: 
“5. PART 5: ADDITIONAL HAZARDS  
5.1. Hazardous to the ozone layer 5.1.1. Definitions and general considerations 
5.1.1.1. Ozone depleting potential (ODP) is an integrative quantity, distinct for each 
halocarbon source species, th at represents the extent of ozone depletion in the 
stratosphere expected from the halocarbon on a mass-for-mass basis relative to CFC-11. The formal definition of ODP is the ratio  of integrated perturbations to total 
ozone, for a differential mass emission of a pa rticular compound relative to an equal 
emission of CFC-11. 
Substance Hazardous to the Ozone Layer m eans a substance which, on the basis of 
the available evidence concerning its properties and its predicted or observed 
environmental fate and behaviour may pres ent a danger to the structure and/or the 
functioning of the stratospheric ozone laye r. This includes substances which are 
listed in Annex I to Regulation (EC) No  1005/2009 of the European Parliament and 
of the Council of 16 September 2009 on substa nces that deplete the ozone layer*. 
5.1.2. Classification criteria for substances  
5.1.2.1. A substance shall be classified as Hazardous  to the Ozone Layer (Category 1) if the 
available evidence concerning its prope rties and its predicted or observed 
environmental fate and behaviour indicate  that it may present a danger to the 
structure and/or the functioning of  the stratospheric ozone layer. 
5.1.3. Classification criteria for mixtures  
5.1.3.1. Mixtures shall be classified as Hazar dous to the Ozone Layer (Category 1) on the 
basis of the individual concen tration of the substance(s) contained therein that are 
also classified as Hazardous to the Ozone  Layer (Category 1), in accordance with 
Table 5.1. EN 48   EN Table 5.1  
Generic concentration limits fo r substances (in a mixture), 
classified as Hazardous  to the Ozone Layer (Category 1) , that trigger classification 
of the mixture as Hazardous  to the Ozone Layer (Category 1) 
Classification of the substance Classification of the mixture 
Hazardous to the ozone layer (Category 1) C ≥ 0,1 % 
 
5.1.4. Hazard Communication  
5.1.4.1. Label elements shall be used for substa nces or mixtures m eeting the criteria for 
classification in this hazard cl ass in accordance with Table 5.2 
Table 5.2  
Label elements for Hazardous  to the Ozone Layer 
Symbol/pictogram 
 
Signal Word Warning 
Hazard Statement  
H420: Harms public health and the 
environment by destroying ozone in the 
upper atmosphere 
Precautionary Statements  
P502 
_____________ 
(*) OJ L 286, 31.10.2009, p. 1.” EN 49   EN ANNEX II  
Annex II to Regulation (EC) No 1272/2008 is amended as follows: 
(1) Part 2, section 2.8. is replaced by the following: 
“2.8 Mixtures containing at le ast one sensitising substance 
The label on the packaging of mixtures not classified as sensitising but containing at 
least one substance classified as sensitising and present in a concentration equal to or 
greater than that specified in Table 3. 4.6 of Annex I shall bear the statement: 
EUH208 — ‘Contains (name of sensitisi ng substance). May pr oduce an allergic 
reaction’. 
Mixtures classified as sens itising containing other su bstance(s) classified as 
sensitising (in addition to the one that lead s to the classification of the mixture) and 
present in a concentration equal to or gr eater than that specified in Table 3.4.6 of 
Annex I shall bear the name(s) of th at/those substance(s) on the label.”; 
(2) In Part 3, section 3.2.2.1, is replaced by the following: 
“This provision does not apply to aerosols which are only classified and labelled as 
‘flammable aerosols, Category 1’ or ‘fla mmable aerosols, Category 2’. It does not 
apply either to transpor table gas receptacles.” EN 50   EN ANNEX III  
Annex III to Regulation (EC) No 1272/2008 is amended as follows: 
(1) Part 1 shall be amended as follows: 
(a) The introductory sentence is replaced by the following: “The hazard statements shall be applied in  accordance with Parts 2, 3 and 4 of Annex 
I. 
In accordance with Article 27 the following principles of precedence for hazard 
statements may apply to labelling: 
(a) If the hazard statement H410 “Very t oxic to aquatic life with long lasting 
effects” is assigned, the statement H400 “Very toxic to aquatic life” may 
be omitted; 
(b) If the statement H314 “Causes seve re skin burns and eye damage” is 
assigned, the statement H318 “Cause s serious eye damage” may be 
omitted. 
In order to indicate the r oute of administration or e xposure the combined hazard 
statements in Table 1.2 may be used.”; 
(b) In Table 1.1, the footnote to code H200 is deleted; (c) Table 1.2 is amended as follows: 
(i) in Code H317, th e title of the 3
rd column is replaced by the following: 
“3.4 – Sensitisation – Skin, Hazard Category 1, 1A, 1B”; 
(ii) in Code H334, the title of the 3rd column is replaced by the following: 
“3.4 – Sensitisation – Respiratory, Hazard Category 1, 1A, 1B”; 
(iii) the following combined hazard stat ements are added to the Table after 
Code H373: EN 51   EN “ 
H300 
+ 
H310 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 1, 2 
 BG  
 ES Mortal en caso de ingestión o en contacto con la piel 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Fatal if swallowed or in contact with skin  
 FR Mortel par ingestion ou par contact cutané  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  EN 52   EN H300 
+ 
H310 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 1, 2 
 SV  
 
H300 
+ 
H330 Language 3.1 – Acute toxicity (oral) and acute  toxicity (inhal ation), Hazard 
Category 1, 2 
 BG  
 ES Mortal en caso de ingestión o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Fatal if swallowed or if inhaled  
 FR Mortel par ingestion ou par inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  EN 53   EN H300 
+ 
H330 Language 3.1 – Acute toxicity (oral) and acute  toxicity (inhal ation), Hazard 
Category 1, 2 
 SL  
 FI  
 SV  
 
H310 
+ 
H330 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 1, 2 
 BG  
 ES Mortal en contacto con la  piel o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Fatal in contact with skin or if inhaled  
 FR Mortel par contact cutané ou par inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  EN 54   EN H310 
+ 
H330 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 1, 2 
 RO  
 SK  
 SL  
 FI  
 SV  
 
H300 + H310 + H330 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 1, 2 
 BG  
 ES Mortal en caso de ingestión, en contacto con la piel o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Fatal if swallowed, in contact with skin or if inhaled  
 FR Mortel par ingestion, par contact cutané ou par inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  EN 55   EN H300 + 
H310 + H330 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 1, 2 
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H301 
+ 
H311 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 3 
 BG  
 ES Tóxico en caso de ingestión o en contacto con la piel 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Toxic if swallowed or in contact with skin  
 FR Toxique par ingestion ou par contact cutané  
 GA  
 IT  
 LV  
 LT  
 HU  EN 56   EN H301 
+ 
H311 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 3 
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H301 
+ 
H331 Language 3.1 – Acute toxicity (oral) and acu te toxicity (inh alation), Hazard 
Category 3 
 BG  
 ES Tóxico en caso de ingestión o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Toxic if swallowed or if inhaled  
 FR Toxique par ingestion ou par inhalation  
 GA  
 IT  
 LV  EN 57   EN H301 
+ 
H331 Language 3.1 – Acute toxicity (oral) and acu te toxicity (inh alation), Hazard 
Category 3 
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H311 
+ 
H331 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 3 
 BG  
 ES Tóxico en contacto con la piel o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Toxic in contact with skin or if inhaled  
 FR Toxique par contact cutané ou par inhalation  
 GA  EN 58   EN H311 
+ 
H331 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 3 
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H301 + H311 + H331 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 3 
 BG  
 ES Tóxico en caso de ingestión, en contacto con la piel o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Toxic if swallowed, in contact with skin or if inhaled  EN 59   EN H301 + 
H311 + H331 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 3 
 FR Toxique par ingestion, par contact cutané ou par inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H302 
+ 
H312 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 4 
 BG  
 ES Nocivo en caso de ingestión o en contacto con la piel 
 CS  
 DA  
 DE  
 ET  EN 60   EN H302 
+ 
H312 Language 3.1 – Acute toxicity (oral) and ac ute toxicity (dermal), Hazard 
Category 4 
 EL  
 EN Harmful if swallowed or in contact with skin  
 FR Nocif en cas d’ingestion ou de contact cutané  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H302 
+ 
H332 Language 3.1 – Acute toxicity (oral) and acu te toxicity (inh alation), Hazard 
Category 4 
 BG  
 ES Nocivo en caso de ingestión o si se inhala 
 CS  
 DA  EN 61   EN H302 
+ 
H332 Language 3.1 – Acute toxicity (oral) and acu te toxicity (inh alation), Hazard 
Category 4 
 DE  
 ET  
 EL  
 EN Harmful if swallowed or if inhaled  
 FR Nocif en cas d’ingestion ou d’inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H312 
+ 
H332 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 4 
 BG  
 ES Nocivo en contacto con la piel o si se inhala EN 62   EN H312 
+ 
H332 Language 3.1 – Acute toxicity (dermal) an d acute toxicity (inhalation), 
Hazard Category 4 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Harmful in contact with skin or if inhaled  
 FR Nocif en cas de contact cutané ou d’inhalation 
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 
H302 + H312 + H332 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 4 EN 63   EN H302 + 
H312 + H332 Language 3.1 – Acute toxicity (oral), acute  toxicity (dermal) and acute 
toxicity (inhalation) , Hazard Category 4 
 BG  
 ES Nocivo en caso de ingestión, en contacto con la piel o si se inhala 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Harmful if swallowed, in contact with skin or if inhaled  
 FR Nocif en cas d’ingestion, de contact cutané ou d’inhalation  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  
 SV  
 (d) Table 1.3 is amended as follows: EN 64   EN (i) the following new hazard statement is added to the Table after Code H413: 
H420 Language 5.1– Hazardous to the ozone layer – Hazard Category 1 
 BG  
 ES Causa daños a la salud pública y el medio ambiente al destruir el ozono en la atmósfera 
superior 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Harms public health and the environment by destroying ozone in the upper atmosphere  
 FR Nuit à la santé publique et à l’environnement en détruisant l’ozone dans la haute 
atmosphère  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  EN 65   EN H420 Language 5.1– Hazardous to the ozone layer – Hazard Category 1 
 SV  
” 
(2) In Part 2, Table 2.3 is deleted; 
(3) Part 3 is amended as follows: 
(a) In the title the words 'substances and' are deleted;  
(b) In Code EUH201/201A, first column, all references to '201/201A' are deleted; 
(c) In Code EUH209/209A, first column, all references to '209/209A' are deleted. EN 66   EN ANNEX IV  
Annex IV to Regulation (EC) No 1272/2008 is amended as follows: 
(1) Part 1 is amended as follows: 
(a)  Table 6.2 is amended as follows:  
(i) Code P261 is replaced by the following: “ 
Acute toxicity – inhalation 
(section 3.1) 3, 4 
Respiratory sensitisation 
(section 3.4) 1, 1A, 1B
Skin sensitisation (section 3.4) 1, 1A, 1B
Specific target organ toxicity – 
single exposure; respiratory tract irritation (section 3.8) 3 P261 Avoid breathing 
dust/fume/gas/mist/vapours/spray. 
Specific target organ toxicity – 
single exposure; narcosis (section 3.8) 3 Manufacturer/supplier 
to specify applicable conditions. 
” 
(ii) Code P272 is replaced by the following: “ 
P272 Contaminated work 
clothing should not be allowed out of the workplace. Skin sensitisation (section 3.4) 1, 1A, 1B  
” 
(iii) Code P280 is replaced by the following: “ 
P280 Wear protective 
gloves/protective clothing/eye protection/face protection . Explosives (section 2.1) Divisions 
1.1, 1.2, 1.3, 1.4, 
1.5 Manufacturer/supplier 
to specify type of equipment. 
- Specify face 
protection. EN 67   EN Flammable liquids (section 
2.6) 1, 2, 3 
Flammable solids (section 2.7) 1, 2 
Self-reactive substances and 
mixtures (section 2.8) Types A, 
B, C, D, 
E, F 
Pyrophoric liquids (section 2.9) 1 
Pyrophoric solids (section 
2.10) 1 
Self-heating substances and 
mixtures (section 2.11) 1, 2 
Substances and mixtures 
which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 
Oxidising liquids (section 
2.13) 1, 2, 3 
Oxidising solids (section 2.14) 1, 2, 3 
Organic peroxides (section 
2.15) Types A, 
B, C, D, 
E, F Manufacturer/supplier 
to specify type of equipment. 
- Specify protective 
gloves and eye/face protection. 
Acute toxicity – dermal (section 3.1) 1, 2, 3, 4 Manufacturer/supplier 
to specify type of equipment. 
- Specify protective 
gloves/clothing. 
Skin corrosion (section 3.2) 1A, 1B, 
1C Manufacturer/supplier 
to specify type of equipment. 
- Specify protective 
gloves/clothing and eye/face protection. 
  Skin irritation (section 3. 2) 2 Manufacturer/supplier EN 68   EN Skin sensitisation (section 3.4) 1, 1A, 1Bto specify type of 
equipment. 
- Specify protective 
gloves. 
Severe eye damage (section 3.3) 1 
Eye irritation (s ection 3.3) 2 Manufacturer/supplier 
to specify type of equipment. 
- Specify eye/face 
protection. 
” 
 (iv) Code P285 is replaced by the following: “ 
P285 In case of 
inadequate ventilation wear respiratory protection. Respiratory sensitisation 
(section 3.4) 1, 1A, 1B Manufacturer/supplier 
to specify equipment. 
” 
 (v) Code P273 is amended as follows:  
 - in column 3, row 2, the words “ch ronic aquatic hazar d (section 4.1)” are 
replaced by “long-term aquatic hazard (section 4.1)”; 
 - the last row is deleted; 
(b) Table 6.3 is amended as follows: 
 (i) Code P302 is replaced by the following: “ 
Pyrophoric liquids (section 
2.9) 1 
Acute toxicity – dermal 
(section 3.1)  1, 2, 3, 4
Skin irritation (section 3.2) 2 P302 IF ON SKIN: 
Skin sensitisation (section 3.4) 1, 1A, 1B 
” 
 (ii) Code P304 is amended as follows:  EN 69   EN “ 
Acute toxicity – inhalation 
(section 3.1)  1, 2, 3, 4
Skin corrosion (section 3.2)  1A, 1B, 
1C 
Respiratory sensitisation (section 3.4) 1, 1A, 1B
Specific target organ toxicity –
single exposure; respiratory tract irritation (section 3.8) 3 P304  IF INHALED: 
Specific target organ toxicity –
single exposure; narcosis (section 3.8) 3  
” 
(iii) Code P311 is amended as follows:  “ 
Acute toxicity – inhalation 
(section 3.1)  3 
Respiratory sensitisation 
(section 3.4) 1, 1A, 1BP311 Call a POISON 
CENTER or 
doctor/physician. 
Specific target organ toxicity –
single exposure (section 3.8)  1, 2  
” 
(iv) Code P313 is amended as follows:  “ 
Skin irritation (section 3.2)  2, 3 
Eye irritation (section 3.3)  2 
Skin sensitisation (section 3.4) 1, 1A, 1B 
Germ cell mutagenicity 
(section 3.5) 1A, 1B, 2 P313 Get medical 
advice/attention.  
Carcinogenicity (section 3.6) 1A, 1B, 2  EN 70   EN Reproductive toxicity (section 
3.7) 1A, 1B, 2 
Reproductive toxicity – effects 
on or via lactation (section 3.7)Additional 
category 
” 
(v) Code P321 is amended as follows:  “ 
Acute toxicity – oral (section 
3.1) 1, 2, 3 … Reference to 
supplemental first aid instruction. 
- if immediate 
administration of antidote is 
required . 
Acute toxicity – inhalation 
(section 3.1)  3 ... Reference to 
supplemental first aid instruction. 
- if immediate 
specific measures 
are required . 
Specific target organ toxicity –
single exposure (section 3.8)  1 ... Reference to 
supplemental first aid instruction. 
- if immediate 
measures are 
required . 
Skin sensitisation (section 3.4) 1, 1A, 1B 
Skin corrosion (section 3.2) 1A, 1B, 
1C P321 Specific treatment 
(see ... on this label). 
Skin irritation (section 3.2) 2 ... Reference to 
supplemental first aid instruction. 
-
 manufacturer/supplier may specify a cleansing agent if appropriate. EN 71   EN ” 
(vi) Code P333 is amended as follows:  “ 
P333 If skin irritation or 
rash occurs: Skin sensitisation (section 3.4) 1, 1A, 1B  
” 
(vii) Code P341 is amended as follows:  “ 
P341 If breathing is 
difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. Respiratory sensitisation 
(section 3.4) 1, 1A, 1B 
 
” 
(viii) Code P342 is amended as follows:  “ 
P342 If experiencing 
respiratory symptoms: Respiratory sensitisation 
(section 3.4) 1, 1A, 1B 
 
” 
(ix) Code P352 is amended as follows:  “ 
Acute toxicity – dermal 
(section 3.1)  3, 4 
Skin irritation (section 3.2)  2 P352 Wash with plenty 
of soap and water. 
Skin sensitisation (section 3.4) 1, 1A, 1B  
” 
(x) Code P363 is amended as follows:  “ EN 72   EN Acute toxicity – dermal 
(section 3.1)  1, 2, 3,4  
Skin corrosion (section 3.2)  1A, 1B, 
1C P363 Wash contaminated 
clothing before reuse. 
Skin sensitisation (section 3.4) 1, 1A, 1B  
” 
(xi) Code P302+P352 is amended as follows:  “ 
Acute toxicity – dermal 
(Chapter 3.1)  3, 4 
Skin irritation (Chapter 3.2) 2 P302 
+ 
P352 IF ON SKIN: Wash 
with plenty of soap and water. 
Skin sensitisation (Chapter 
3.4) 1, 1A, 1B  
” 
(xii) Code P304+P341 is amended as follows:  “ 
P304 
+ P341 IF INHALED: If 
breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing. Respiratory sensitisation 
(section 3.4) 1, 1A, 1B 
 
” 
(xiii) Code P333+P313 is amended as follows:  
“ 
P333 
+ 
P313 If skin irritation or 
rash occurs: Get medical advice/attention. Skin sensitisation (section 3.4) 1, 1A, 1B 
 
” 
(xiv) Code P342+P311 is amended as follows:  EN 73   EN “ 
P342 
+ 
P311 If experiencing 
respiratory symptoms: Call a POISON CENTER or doctor/physician. Respiratory sensitisation 
(section 3.4) 1, 1A, 1B 
 
” 
(xv) in Code P391, column 3, row 2, the words “chronic aquatic hazard 
(section 4.1)” are replaced by “long-te rm aquatic hazard (section 4.1)”; 
(c) Table 6.5 is replaced by the following: 
 EN 74   EN  
“Table 6.5  
Precautionary statements – Disposal 
Code 
(1) Disposal 
precautionary 
statements 
(2) Hazard class 
(3) Hazard 
category 
(4) Conditions for use 
(5) 
Explosives (section 2.1) Unstable 
explosives 
and 
Divisions 
1.1, 1.2, 1.3, 1.4, 
1.5 
Flammable liquids (section 2.6)  1, 2, 3 
Self-reactive substances 
and mixtures  (section 2.8)  Types  
A, B, C, 
D, E, F 
Substances and mixtures which, in contact with water, emit flammable gases (section 2.12) 1, 2, 3 
Oxidising liquids 
(section 2.13) 1, 2, 3 
Oxidising solids 
(section 2.14) 1, 2, 3 
Organic peroxides 
(section 2.15) Types  
A, B, C, 
D, E, F 
Acute toxicity – oral (section 3.1)  1, 2, 3, 4 
Acute toxicity – dermal 
(section 3.1)  1, 2, 3, 4 
Acute toxicity – 
inhalation (section 3.1)  1, 2 P501 Dispose of 
contents/container to ... 
Skin corrosion (section 
3.2) 1A, 1B, 
1C ... in accordance 
with local/regional/ national/international regulation (to be specified).  EN 75   EN Code 
(1) Disposal 
precautionary 
statements 
(2) Hazard class 
(3) Hazard 
category 
(4) Conditions for use 
(5) 
Respiratory sensitisation 
(section 3.4) 1, 1A, 1B
Skin sensitisation 
(section 3.4) 1, 1A, 1B
Germ cell mutagenicity 
(section 3.5) 1A, 1B, 2
Carcinogenicity (section 
3.6) 1A, 1B, 2
Reproductive toxicity 
(section 3.7) 1A, 1B, 2
Specific target organ 
toxicity – single exposure (section 3.8)  1, 2 
Specific target organ 
toxicity – single exposure; respiratory tract irritation (section 3.8) 3 
Specific target organ 
toxicity – single exposure; narcosis (section 3.8) 3 
Specific target organ 
toxicity – repeated exposure (section 3.9) 1, 2 
Aspiration hazard 
(section 3.10)  1 
Hazardous to the aquatic 
environment – acute aquatic hazard(section 
4.1)  1 P501 (cont'd)   
Hazardous to the aquatic 
environment – long-term aquatic hazard (section 4.1)  1, 2, 3, 4 
P502 Refer to 
manufacturer/supplier for information on recovery/recycling  Hazardous to the ozone 
layer (section 5.1) 
1  
“ EN 76   EN (2) In Part 2, Table 1.5, the following precautiona ry statement is added after Code P501: 
“ 
P502 Language  
 BG  
 ES Pedir información al fabricante/proveedor sobre la recuperación/reciclado 
 CS  
 DA  
 DE  
 ET  
 EL  
 EN Refer to manufacturer/supplier for information on recovery/recycling  
 FR Se reporter au fabricant/fournisseur pour des informations concernant la 
récupération/le recyclage  
 GA  
 IT  
 LV  
 LT  
 HU  
 MT  
 NL  
 PL  
 PT  
 RO  
 SK  
 SL  
 FI  EN 77   EN P502 Language  
 SV  
“ 
 EN 78   EN ANNEX V  
Annex V to Regulation (EC) No 1272/2008 is amended as follows: 
(1) The first sentence is replaced by the following:  
“The hazard pictograms for each hazard cla ss, differentiation of a hazard class and 
hazard category shall satisfy the provisions of this Annex and A nnex I, section 1.2 
and conform in terms of symbols and gene ral format, to the specimens shown.”;  
(2) In Part 2, section 2.3, column 2 the words “Skin sensitisation, hazard category 1” are 
replaced by “Skin sensitisati on, hazard categories 1, 1A, 1B”; 
(3) In Part 2, section 2.4, column 2, the word s “Respiratory sensiti sation, hazard category 
1” are replaced by “Skin sensitisa tion, hazard categories 1, 1A, 1B”; 
(4) In Part 3, the pictogram GHS09 is replaced by the following pictogram: 
“GHS09 
”; 
(5) The following new Part 4 is added: 
“4. PART 4: ADDITIONAL HAZARDS 4.1. Symbol: exclamation mark 
Pictogram 
(1) Hazard class and hazard category 
(2) 
GHS07 
 Section 5.1  
Hazardous to the ozone layer, hazard category 1 
” EN 79   EN ANNEX VI  
Annex VI to Regulation (EC) No 1272/2008 is amended as follows: 
(1) Part 1 is amended as follows: 
(a) In Table 1.1, in the Hazar d Class respiratory/skin sensitisation, the Category 
Code 'Resp. Sens. 1' is replaced by 'Resp. Sens. 1, 1A, 1B' and the Category 
Code 'Skin Sens. 1' is replaced by 'Skin. Sens. 1, 1A, 1B'; 
(b) In section 1.1.2.3, the last paragraph is replaced by the following: 
“In case an M-factor has b een harmonised for substances classified as hazardous to 
the aquatic environment in the categories Aquatic Acute 1 or Aquatic Chronic 1, this 
M-factor is given in Table 3.1 in the sa me column as the specific concentration 
limits.  In case an M-factor for Aquatic Acute 1 and an M-factor for Aquatic Chronic 
1 have been harmonised, each M-factor shall be listed in the same line as its corresponding differentiation.  Where a single M-factor is given in Table 3.1 and the 
substance is classified as Aquatic Acute 1 and Aquatic Chronic 1, this M-factor shall 
be used for the classification for aquatic acute and long-term hazards  when a mixture 
including the substance is classified by the manufacturer, importer or downstream 
user using the summation method.  Where no M-factor is  given in Table  3.1, M-
factor(s) based on available data for the substance shall be set by the manufacturer, 
importer or downstream user. For the sett ing and use of M-factors, see section 
4.1.2.5.5.5 of Annex I.”; 
(c) In section 1.1.3.1, ‘Note H (T able 3.1)’ and ‘Note H (Table 3.2)’ are deleted;  
(d) Section 1.1.4.4 is deleted; 
(2) Part 3, is amended as follows: 
(a) The first two paragraphs are replaced by the following: 
“Table 3.1: List of harmonised classifica tion and labelling of hazardous substances. 
Table 3.2: The list of harmonised classifica tion and labelling of hazardous substances 
from Annex I to Di rective 67/548/EEC.”; 
(b) In Tables 3.1 and 3.2, last column, all th e references to Note ‘H’ are deleted. EN 80   EN ANNEX VII  
Annex VII to Regulation (EC) No 1272/2008 is amended as follows: 
In Table 1.1, last row, the hazard statement “EUH059” is replaced by “H420”.