EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION REGULATION (EU) .../... of XXX  
amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of 
the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH)    
EN 1  EN ANNEX  
ANNEX II 
REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS   
PART A  
0.1. Introduction  
0.1.1.  This Annex sets out the requirements that the supplier shall fulfil for the compilation 
of a safety data sheet that is provided for a substance or a mixture in accordance with Article 
31. 
0.1.2.  The information on substances provided in the safety data she et shall be consistent 
with the information in the registration and in the chemical safety report, where required. 
Where a chemical safety report has been completed, the relevant exposure scenario(s) shall be 
placed in an annex to the safety data sheet.  
0.1.3 The safety data sheet shall mention in each relevant section whether and which 
different nanoforms it covers and link the relevant safety information  to each of those 
nanoforms . As provided for  in Annex VI, t he term ‘nanoform’  in this Annex  refers to  a 
nanoform or a set of similar nanoforms.   
0.2. General requirements for compiling a safety data sheet  
0.2.1.  The safety data sheet shall enable users to take the necessary measures relating to 
protection of human health and safety at the workplace, and protection of the environment. 
The writer of the safety data sheet shall take into account that a safety data sheet must inform 
its audience of the hazards of a substance or a mixture and provide information on the safe 
storage, handling and disposal of th e substance or the mixture.  
0.2.2.  The information provided by safety data sheets shall also meet the requirements set 
out in Directive 98/24/EC. In particular, the safety data sheet shall enable employers to 
determine whether any hazardous chemical agents  are present in the workplace and to assess 
any risk to the health and safety of workers arising from their use.  
0.2.3.  The information in the safety data sheet shall be written in a clear and concise manner. 
The safety data sheet shall be prepared by a co mpetent person who shall take into account the 
specific needs and knowledge of the user audience, as far as they are known. Suppliers of 
substances and mixtures shall ensure that such competent persons have received appropriate 
training, including refreshe r training.  
0.2.4.  The language used in the safety data sheet shall be simple, clear and precise, avoiding 
jargon, acronyms and abbreviations. Statements such as “may be dangerous”, “no health 
effects”, “safe under most conditions of use” or “harmless” or any other statements indicating 
that the substance or mixture is not hazardous or any other statements that are inconsistent 
with the classification of that substance or mixture shall not be used.  
0.2.5.  The date of compilation of the safety data sheet sha ll be given on the first page. When 
a safety data sheet has been revised and the new, revised version is provided to recipients, the 
changes shall be brought to the attention of the recipients in Section 16 of the safety data 
sheet, unless the changes have  been indicated elsewhere. For the revised safety data sheets, 
the date of compilation, identified as ‘Revision: (date)’, shall appear on the first page, as well 
as one or more indications of which version is replaced, such as version number, revision 
numb er, or supersedes date.  
0.3. Safety data sheet format   
EN 2  EN 0.3.1.  A safety data sheet is not a fixed length document. The length of the safety data sheet 
shall be commensurate with the hazard of the substance or mixture and the information 
available.  
0.3.2.  All pages of a safety data sheet, including any annexes, shall be numbered and shall 
bear either an indication of the length of the safety data sheet (such as “page 1 of 3”) or an 
indication whether there is a page following (such as “Continued on next page” or “End of 
safety data sheet”).  
0.4. Safet y data sheet content  
The information required by this Annex shall be included in the safety data sheet, where 
applicable and available, in the relevant subsections set out in Part  B. The safety data sheet 
shall not  contain blank subsections.  
0.5. Other information requirements  
The inclusion of additional relevant and available information in the relevant subsections may 
be necessary in some cases in view of the wide range of properties of substances and 
mixtures.  
Additional safety and environmental information is required to address the needs of seafarers 
and other transport workers in the bulk transport of dangerous goods in sea -going or inland 
navigation bulk carriers or tank -vessels subject to International Mariti me Organisation (IMO) 
or national regulations. Subsection 14.7. recommends the inclusion of basic classification 
information when such cargoes are transported in bulk according to the relevant IMO 
instruments. In addition, ships carrying oil or oil fuel, a s defined in Annex I of MARPOL  (1), 
in bulk or bunkering oil fuel are required, before loading, to be provided with a “material 
safety data sheet” in accordance with the IMO’s Maritime Safety Committee (MSC) 
resolution “Recommendations for Material Safety Data Sheets (MSDS) for MARPOL Annex 
I Oil Cargo and Oil Fuel” (MSC.286(86)). Therefore, in order to have one harmonised safety 
data sheet for maritime and non -maritime use, the additional provisions of Resolution 
MSC.286(86) may be included in the safety d ata sheets, where appropriate, for marine 
transport of MARPOL Annex I cargoes and marine fuel oils.  
0.6. Units  
The units of measurement as set out in Council Directive 80/181/EEC (2) shall be used.  
0.7. Special cases  
Safety data sheets shall also be required for the special cases listed in paragraph 1.3 of Annex 
I to Regulation (EC) No 1272/2008 for which there are labelling derogations.  
 
1. SECTION 1: Identification of the substance/mixture and of the company/undertaking  
This section of the safety da ta sheet shall prescribe how the substance or mixture shall be 
identified and how the identified relevant uses, the name of the supplier of the substance or 
mixture and the contact detail information of the supplier of the substance or mixture, 
including a n emergency contact, shall be provided in the safety data sheet.  
1.1. Product identifier  
                                                 
1 Marpol – Consolidated edition 2006, London, IMO 2007, ISBN 978 -92-801-4216 -7. 
2 OJ L 39, 15.2.1980, p.  40.  
EN 3  EN The product identifier shall be provided in accordance with Article 18(2) of Regulation (EC) 
No 1272/2008 in the case of a substance and in accordance with Article 18( 3)(a) of 
Regulation (EC) No 1272/2008 in the case of a mixture, and as provided on the label in the 
official language(s) of the Member State(s) where the substance or mixture is placed on the 
market, unless the Member State(s) concerned provide(s) otherwis e. 
For substances subject to registration, the product identifier shall be consistent with that 
provided in the registration and the registration number assigned under Article  20(3) of this 
Regulation shall also be indicated. Additional identifiers may be provided even if they have 
not been  used in the registration.  
Without affecting the obligations of downstream users laid down in Article  39 of this 
Regulation, the part of the registration number referring to the individual registrant of a joint 
submission  may be omitted by a supplier who is a distributor or a downstream user provided 
that: 
(a) this supplier assumes the responsibility to provide the full registration number upon 
request for enforcement purposes or, if the full registration number is not ava ilable to 
him, to forward the request to his supplier, in line with point (b); and  
(b) this supplier provides the full registration number to the Member State authority 
responsible for enforcement (the enforcement authority) within 7 days upon request, 
received either directly from the enforcement authority or forwarded by his recipient, 
or, if the full registration number is not available to him, this supplier shall forward the 
request to his supplier within 7 days upon request and at the same time info rm the 
enforcement authority thereof.  
A single safety data sheet may be provided to cover more than one substance or mixture 
where the information in that safety data sheet fulfils the requirements of this Annex for each 
of those substances or mixtures.  
Where different forms of a substance  are covered by one safety data sheet , relevant  
information shall be included, clearly indicating which information is related to which form. 
Alternatively, a separate safety data sheet may be prepared per form or group o f forms.  
If the safety data sheet pertains to one or more nanoform s, or substances that include 
nanoforms, this shall be indicated  by using the word “nanoform”.  
Other means of identification  
Other names or synonyms by which the substance or mixture is labe lled or commonly known 
may be provided.  
If the mixture has a unique formula identifier (UFI) in accordance with section  5 of Part A  of 
Annex  VIII to Regulation (EC) No  1272/2008 and if a derogation from section  5.2 of Part A  
of that Annex  is applied in accorda nce with section  5.3 of Part A  of that Annex  as a result of 
which the UFI needs to  be indicated in the safety data sheet , then the UFI shall be provided  in 
this subsection . 
1.2. Relevant identified uses of the substance or mixture and  uses advised against  
At least a brief description of the identified uses ( for example , floor cleaning, or industrial use 
in polymer production, or professional use in cleaning agents ) relevant for the recipient(s) of 
the substance or mixtu re shall be indi cated.  
The uses which the supplier advises against and the reasons why shall, where applicable, be 
stated. This need not be an exhaustive list.   
EN 4  EN Where a chemical safety report is required, the information in this subsection of the safety 
data sheet shall be  consistent with the identified uses in the chemical safety report and the 
exposure scenarios from the chemical safety report set out in the annex to the safety data 
sheet.  
1.3. Details of the supplier of the safety data sheet  
The supplier of the safety da ta sheet, whether it is the manufacturer, importer, only 
representative, downstream user or distributor, shall be identified. The full address and 
telephone number of the supplier shall be given as well as an e -mail address for a competent 
person responsib le for the safety data sheet.  
In addition, if the supplier is not located in the Member State where the substance or mixture 
is placed on the market and he has nominated a responsible person for that Member State, a 
full address and telephone number for th at responsible person shall be given.  
Where an only representative has been appointed, details of the non -Union manufacturer or 
formulator may also be provided.  
For registrants, the information provided in this subsection on the supplier of the safety data  
sheet and, if provided, the information on the supplier of the substance or mixture, shall be 
consistent with the information on the identity of the manufacturer, importer or only 
representative provided in the registration.  
1.4. Emergency telephone numbe r 
References to emergency information services shall be provided. If an official advisory body 
exists in the Member State where the substance or mixture is placed on the market (this may 
be the body responsible for receiving information relating to health referred to in Article  45 of 
Regulation (EC) No  1272/2008), its telephone number shall be given and can suffice. If 
availability of such services is limited for any reasons, such as hours of operation, or if there 
are limits on specific types of informatio n provided, this shall be clearly stated.  
 
2. SECTION 2: Hazards identification  
This section of the safety data sheet shall describe the hazards of the substance or mixture and 
the appropriate warning information associated with those hazards.  
2.1. Classif ication of the substance or mixture  
The classification of the substance or the mixture which results from the application of the 
classification criteria in Regulation (EC) No  1272/2008 shall be given. Where the supplier has 
notified information regarding t he substance to the classification and labelling inventory in 
accordance with A rticle  40 of Regulation (EC) No  1272/2008, or has provided that 
information as part of a registration pursuant to this Regulation , the classification given in the 
safety data sheet shall be the same as the classification provided in that notification or 
registration.  
If the mixture does not meet the criteria for classification in accordance with Regulation (EC) 
No 1272/2008, this shall b e clearly stated.  
Information on the substances in the mixture is provided under subsection 3.2.  
If the classification, including the hazard statements, is not written out in full, reference shall 
be made to section  16 where the full text of each classific ation, including each hazard 
statement, shall be given.   
EN 5  EN The most important adverse physical, human health and environmental effects shall be listed 
in accordance with sections  9 to 12 of the safety data sheet, in such a way as to allow non -
experts to ident ify the hazards of the substance or mixture.  
2.2. Label elements  
Based on the classification, at least the following elements appearing on the label in 
accordance with Regulation (EC) No  1272/2008 shall be provided : hazard pictogram(s), 
signal word(s), hazard statement(s) and precautionary statement(s). A graphical reproduction 
of the full hazard pictogram in black and white or a graphical reproduction of the symbol only 
may be substituted for the colour pictogram p rovided in Regulation (EC) No 1272/2008.  
The applicable label elements in accordance with Article  25(1) to (6) and Article  32(6) of 
Regulation (EC) No  1272/2008 shall be provided.  
2.3. Other hazards  
Information shall be provided on whether the substance or  mixture meets the criteria for 
persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in 
accordance with Annex  XIII, whether the substance was included in the list established in 
accordance with Article  59(1) for having endocrin e disrupting properties, and whether the 
substance is a substance identified as having endocrine disrupting properties in accordance 
with the criteria set out in Commission Delegated Regulation (EU)  2017/21003 or 
Commission Regulation (EU)  2018/6054 . 
Information shall be provided on other hazards which do not result in classification but which 
may contribute to the overall hazards of the substance or mixture, such as formation of air 
contaminants during hardening or processing, dustiness, explosive propert ies which do not 
fulfil the classification criteria of part 2 Section 2.1. of Annex I to Regulation (EC) No 
1272/2008, dust explosion hazards, cross -sensitisation, suffocation, freezing, high potency for 
odour or taste, or environmental effects like hazard s to soil -dwelling organisms, or 
photochemical ozone creation potential. The statement “May form explosible dust -air mixture 
if dispersed” is appropriate in the case of a dust explosion hazard.  
 
3. SECTION 3: Composition/information on ingredients  
This sec tion of the safety data sheet shall describe the chemical identity of the ingredient(s) of 
the substance or mixture, including impurities and stabilising additives as set out below. 
Appropriate and available safety information on surface chemistry shall be  indicated.  
3.1. Substances  
The chemical identity of the main constituent of the substance shall be provided by providing 
at least the product identifier or one of the other means of identif ication given in subsection 
1.1. 
The chemical identity of any impu rity, stabilising additive, or individual constituent other 
than the main constituent, which is itself classified and which contributes to the classification 
of the substance shall be provided as follows:  
                                                 
3 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria 
for the determination of endocrine -disrupting properties pursuant to Regulation (EU) No 528/2012 of 
the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).  
4 Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ 
L 101, 20.4.2018, p. 33).   
EN 6  EN (a) the product identifier in accordance with Artic le 18(2) of Regulation (EC) 
No 1272/2008;  
(b) if the product identifier is not available, one of the other names (usual name, trade 
name, abbreviation) or identification numbers.  
Suppliers of substances may choose to list in addition all constituents inclu ding non -classified 
ones.  
This subsection may also be used to provide information on multi -constituent substances.  
The s pecific concentration limit and M-factor for substance s included  in Part  3 of Annex  VI 
to Regulation (EC) No  1272/2008 or provided to th e classification and labelling inventory 
established under that Regulation shall be indicated, if available . The a cute toxicity estimate 
for substance s included  in Part 3 of Annex  VI to Regulation (EC) No  1272/2008 or 
determined  in accordance  with Annex  I to that Regulation shall be indicated , if available . 
If the substance is registered and it covers a nanoform , the particle characteristics that specify 
the nanoform , as described in Annex VI, shall be indicated . 
If the substance is not registered, but the safety data sheet covers nanoform s, the particle 
characteristics of which have impact  on the safety of the substance, th ose characteristics shall 
be indicated . 
3.2. Mixtures  
The product identifier, the concentrat ion or concentration ranges and the classifications shall 
be provided for at least all substances referred to in points 3.2.1 or 3.2.2. Suppliers of 
mixtures may choose to list in addition all substances in the mixture, including substances not 
meeting the  criteria for classification. This information shall enable the recipient to identify 
readily the hazards of the substances in the mixture. The hazards of the mixture itself shall be 
given in section 2.  
The concentrations of the substances in a mixture sha ll be described as either of the following:  
(a) exact percentages in descending order by mass or volume, if technically possible;  
(b) ranges of percentages in descending order by mass or volume, if technically possible.  
When using a range of percentages, if the effects of the mixture as a whole are not available , 
the health and environmental hazards shall describe the effects of the highest concentration of 
each ingredient.  
If the effects of the mixture as a whole are available, this information shall be included under 
section 2.  
Where the use of an alternative chemical name is permitted in accordance with Article  24 of 
Regulation (EC) No  1272/2008, that name can be used.  
3.2.1 For a mixture meeting the criteria for classification in accordance with Regulation 
(EC) No  1272/2008, the following substances shall be indicated, together with their 
concentration or concentration range in the mixture:  
(a) substances presenting a heal th or environmental hazard within the meaning of 
Regulation (EC) No  1272/2008, if those substances are present in 
concentrations equal to or greater than the lowest of any of the following:  
(i) the generic cut -off values set out in Table  1.1 of Annex  I to Regulation 
(EC) No  1272/2008;   
EN 7  EN (ii) the generic concentration limits given in parts  3 to 5 of Annex  I to 
Regulation (EC) No  1272/2008, taking into account the concentrations 
specified in the notes to certa in tables in part  3 in relation to the 
obligation to  make available a safety data sheet for the mixture upon 
request, and for aspiration hazard (Section  3.10 of Annex  I to 
Regulation (EC) No  1272/2008) ≥ 1  %; 
(iii) the specific concentration limits given in Part  3 of Annex  VI to 
Regulation (EC) No  1272/2008 ; 
(iv) if a M -factor has been given in Part  3 of Annex  VI to Regulation (EC) 
No 1272/2008, the generic cut -off value in Table  1.1 of Annex  I to that 
Regulation, adjusted using the calculation set out in Section  4.1 of 
Annex  I to that Regulation;  
(v)  the s pecific concentration limits provided to the classification and 
labelling inventory established under Regulation (EC) No  1272/2008;  
(vi) one tenth of the specific concentration limit for a substance classified as 
skin sensitiser or respiratory sensitiser w ith a specific concentration 
limit;  
(vii) the concentration limits set out in Annex  II to Regulation (EC) 
No 1272/2008;  
(viii) if an M -factor has been provided to the classification and labelling 
inventory established under Regulation (EC) No  1272/2008, the generic 
cut-off value in Table  1.1 of Annex  I to that Regulation, adjusted using 
the calculation set out in Section  4.1 of Annex  I to that Regulation.  
(b) substances for which there are Union workplace exposure limits which are not 
already included und er point (a);  
(c) provided that the concentration of an individual substance is equal to or greater 
than 0,1  %, substances that meet any of the following criteria:   
- substances that are persistent, bioaccumulative and toxic or very persistent 
and very bio accumulative in accordance with the criteria set out in Annex  XIII,  
- substances included in the list established in accordance with Article  59(1) 
for reasons other than the hazards referred to in point (a)  of this subsection 
[such as endocrine disrupting  properties ],  
- substances identified as having endocrine disrupting properties in accordance 
with the criteria set out in Delegated Regulation (EU)  2017/2100 or Regulation 
(EU)  2018/605.  
 
 
 
Table 1.1  
List of hazard classes, hazard categories and concentration limits for which a substance shall 
be listed as a subst ance in a mixture in subsection  3.2.1.  
Hazard class and category  Concentration limit   
EN 8  EN (%) 
Acute toxicity, category 1, 2 and 3  ≥ 0,1  
Acute to xicity, category 4  ≥ 1 
Skin corrosion/irritation, category 1, categories 1A, 1B , 1C and 
category 2  ≥ 1 
Serious damage to eyes/eye irritation, category 1 and 2  ≥ 1 
Respiratory sensitiser category 1 or category 1B  ≥ 0,1  
Respiratory sensitiser category 1A  ≥ 0,01  
Skin sensitiser category 1 or category 1B  ≥ 0,1  
Skin sensitiser category 1A  ≥ 0,01  
Germ cell mutagenicity category 1A and 1B  ≥ 0,1  
Germ cell mutagenicity category 2  ≥ 1 
Carcinogenicity category 1A, 1B and 2  ≥ 0,1  
Reproductive toxicity, category 1A, 1B, 2 and effects on or via 
lactation  ≥ 0,1  
Specific target organ toxicity (STOT) — single exposure, category 1, 
2 and 3  ≥ 1 
Specific target organ toxicity (STOT) — repeated exposure, category 
1 and 2  ≥ 1 
Aspiration toxicity  ≥ 1 
Hazardous to the aquatic environment — Acute, category 1  ≥ 0,1  
Hazardous to the aquatic environment — Chronic, category 1  ≥ 0,1  
Hazardous to the aquatic environment — Chronic, category 2, 3 and 
4 ≥ 1 
Hazardous for the ozone layer  ≥ 0,1  
 
3.2.2  For a mixture not meeting the criteria for classification in accordance with Regulation 
(EC) No  1272/2008, substances present in an individual concentration equal to or 
greater than the following concentrations shall be indicated, together with their 
concentration or concen tration range:  
(a) 1 % by weight in non -gaseous mixtures and 0,2  % by volume in gaseous 
mixtures for:   
EN 9  EN (i) substances which present a health or environmental hazard within the 
meaning of Regulation (EC) No  1272/2008; or  
(ii) substances for which Union workp lace exposure limits have been 
assigned;  
(b) 0,1 % by weight for substances that meet any of the following criteria : 
- substances that are persistent, bioaccumulative and toxic in accordance wit h 
the criteria set out in Annex  XIII,  
- substances that are very persistent and very bioaccumulative in accordance 
with the criteria set out in Annex  XIII,  
- substances included in the list establi shed in accordance with Article  59(1) 
for reasons other than the hazards referred to in point (a)  of this subsection 
such as endocrine disrupting properties ; 
- identified as having endocrine disrupting properties in accordance with the 
criteria set out in Delegated Regulation (EU) 2017/2100 or Regulation (EU) 
2018/605;  
(c) 0,1 % of a substance classified as skin sensitiser  category 1  or 1B, respiratory 
sensitiser category 1  or 1B, or carcinogenic category 2;  
(d) 0,01 % of a substance classified as skin sensitiser category 1A  or respiratory 
sensitiser category 1A;  
(e) one tenth of the specific concentration limit for a subst ance classified as skin 
sensitiser or respiratory sensitiser with a specific concentration limit;  
(f) 0,1 % of a substance classified as toxic to reproduction categories 1A, 1B or 2, 
or with effects on or via lactation.  
3.2.3  For the substances indicated i n subsection  3.2.: 
- the classification of the substance according to Regulation (EC) No  1272/2008, 
including the hazard class(es) and category code(s) as provided in Table  1.1 of 
Annex  VI to that Regulation as well as the hazard statements which are assig ned in 
accordance with their physical, human health and environmental hazards, shall be 
provided. The hazard statements and the supplemental hazard information do not need 
to be written out in full in this subsection; their codes shall be sufficient. In ca ses 
where they are not written out in full, ref erence shall be made to section  16, where the 
full text of each relevant hazard statement shall be listed. If the substance does not 
meet the classification criteria, the reason for indicating the substance in  subsection 
3.2. shall be described, such as “non -classified vPvB substance” or “substance with a 
Union workplace exposure limit”.  
- the specific concentration limit and the M-factor for the substance s included in Part  3 
of Annex  VI to Regulation (EC) No  1272/2008, or provided to the classification and 
labelling inventory established under that Regulation  shall be indicated, if available . 
The a cute toxicity estimate for the substance in Part  3 of Annex  VI to Regulation (EC) 
No 1272/2008 or as determined  in accordance with An nex I to that Regulation  shall be 
indicated , if available . 
- if the substance is registered and it covers a nanoform , the particle characteristics that 
specify the nanoform , as described in Annex  VI, shall be indicated . If the substance is  
EN 10  EN not registered, but includes a nanoform , the particle characteristics of which  have  
impact on the safety of the mixture, these characteristics shall be provided.  
3.2.4.  For the sub stances indicated in subsection  3.2. the name a nd, if available, the 
registration number, as assigned under Article  20(3) of this Regulation, shall be given.  
Without affecting the obligations of downstream users  laid down in Article  39 of this 
Regulation, the part of the registration number referring t o the individual registrant of 
a joint submission may be omitted by the supplier of the mixture provided that:  
(a) this supplier assumes the responsibility to provide the full registration number 
upon request for enforcement purposes or, if the full regist ration number is not 
available to him, to forward the request to his supplier, in line with point (b); 
and 
(b) this supplier provides the full registration number to the Member State 
authority responsible for enforcement (hereinafter referred to as the 
enforcement authority) within seven  days upon request, received either directly 
from the enforcement authority or forwarded by his recipient, or, if the full 
registration number is not available to him, this supplier shall forward the 
request to his supplier within seven  days upon request and at the same time 
inform the enforcement authority thereof.  
The EC number, if available, shall be given in accordance with Regulation (EC) 
No 1272/2008. The CAS number, if available, and the IUPAC name, if available, may 
also be given.  
For substances indicated in this subsection by means of an alternative chemical name 
in accordance with A rticle  24 of Regulation (EC) No  1272/2008, the registration 
number, EC number and other precise chemical identifiers are not necessary.  
 
4. SECTION 4: First aid measures  
This section of the safety data sheet shall describe the initial care in such a way that an 
untrained responder can understand and provide it without the use of sophisticated equipment 
and without the availability of a wide  selection of medications. If medical attention is 
required, the instructions shall state this, including its urgency.  
4.1. Description of first aid measures  
4.1.1.  First aid instructions shall be provided by relevant routes of exposure. Subdivisions 
shall  be used to indicate the procedure for each route, such as inhalation, skin, eye and 
ingestion.  
4.1.2.  Advice shall be provided as to whether:  
(a) immediate medical attention is required and if delayed effects can be expected 
after exposure;  
(b) movement o f the exposed individual from the area to fresh air is 
recommended;  
(c) removal and handling of clothing and shoes from the individual is 
recommended; and  
(d) personal protective equipment for first  aid responders is recommended.  
4.2. Most important sympto ms and effects, both acute and delayed   
EN 11  EN Briefly summarised information shall be provided on the most important symptoms and 
effects, both acute and delayed, from exposure.  
4.3. Indication of any immediate medical attention and special treatment needed  
Where  appropriate, information shall be provided on clinical testing and medical monitoring 
for delayed effects, specific details on antidotes (where they are known) and 
contraindications.  
For some substances or mixtures, it may be important to emphasise that s pecial means to 
provide specific and immediate treatment shall be available at the workplace.  
 
5. SECTION 5: Firefighting measures  
This section of the safety data sheet shall describe the requirements for fighting a fire caused 
by the substance or mixture,  or arising in its vicinity.  
5.1. Extinguishing media  
Suitable extinguishing media:  
Information shall be provided on the appropriate extinguishing media.  
Unsuitable extinguishing media:  
Indications shall be given whether any extinguishing media are inappro priate for a particular 
situation involving the substance or mixture (e.g. avoid high pressure media which could 
cause the formation of a potentially explosible dust -air mixture).  
5.2. Special hazards arising from the substance or mixture  
Information shall  be provided on hazards that may arise from the substance or mixture, like 
hazardous combustion products that form when the substance or mixture burns, such as “may 
produce toxic fumes of carbon monoxide if burning” or “produces oxides of sulphur and 
nitro gen on combustion”.  
5.3. Advice for firefighters  
Advice shall be provided on any protective actions to be taken during firefighting, such as 
“keep containers cool with water spray”, and on special protective equipment for firefighters, 
such as boots, overa lls, gloves, eye and face protection and breathing apparatus.  
 
6. SECTION 6: Accidental release measures  
This section of the safety data sheet shall recommend the appropriate response to spills, leaks, 
or releases, to prevent or minimise the adverse effects on persons, property and the 
environment. It shall distinguish between responses to large and small spi lls, in cases where 
the spill volume has a significant impact on the hazard. If the procedures for containment and 
recovery indicate that different practices are required, these shall be indicated in the safety 
data sheet.  
6.1. Personal precautions, protec tive equipment and emergency procedures  
6.1.1. For non -emergency personnel  
Advice shall be provided related to accidental spills and release of the substance or mixture 
such as:   
EN 12  EN (a) the wearing of suitable protective equipment (including personal protectiv e equipment 
referred to under section 8 of the safety data sheet) to prevent any contamination of 
skin, eyes and personal clothing;  
(b) removal of ignition sources, provision of sufficient ventilation, control of dust; and  
(c) emergency procedures such as the need to evacuate the danger area or to consult an 
expert.  
6.1.2. For emergency responders  
Advice shall be provided related to suitable fabric for personal protective clothing (such as 
“appropriate: Butylene”; “not appropriate: PVC”).  
6.2. Environmental  precautions  
Advice shall be provided on any environmental precautions to be taken related to accidental 
spills and release of the substance or mixture, such as keeping away from drains, surface and 
ground water.  
6.3. Methods and material for containment a nd cleaning up  
6.3.1.  Appropriate advice shall be provided on how to contain a spill. Appropriate 
containment techniques may include any of the following:  
(a) bunding, covering of drains;  
 (b) capping procedures.  
6.3.2.  Appropriate advice shall be provided  on how to clean -up a spill. Appropriate clean -up 
procedures may include any of the following:  
(a) neutralisation techniques;  
(b) decontamination techniques;  
(c) adsorbent materials;  
(d) cleaning techniques;  
(e) vacuuming techniques;  
(f) equipment required  for containment/clean -up (include the use of non -sparking 
tools and equipment where applicable).  
6.3.3.  Any other information shall be provided relating to spills and releases, including 
advice on inappropriate containment or clean -up techniques, such as by indications 
like “never use …”.  
6.4. Reference to other sections  
If appropriate sections  8 and 13 shall be referred to.  
 
7. SECTION 7: Handling and storage  
This section of the safety data sheet shall provide advice on safe handling practices. It shall 
emphasise precautions that are appropriate to the identified us es referred to under 
subsection  1.2. and to the unique properties of the substance or mixture.  
Information in this section of the safety data sheet shall relate to the protection of human 
healt h, safety and the environment. It shall assist the employer in devising suitable working  
EN 13  EN procedures and organisational measures according to Article  5 of D irective  98/24/EC and 
Article  5 of Directive  2004/37/EC.  
Where a chemical safety report is required, the information in this section of the safety data 
sheet shall be consistent with the information given for the identified uses in the chemical 
safety report and the exposure scenarios showing control of risk from the chemical safety 
report set out in the annex to the safety data sheet.  
In addition to information given in this section, relevant information may also be found in 
section  8. 
7.1. Precautions for safe handling  
7.1.1.  Recommendations shall be specified to:  
(a) allow safe handling of the substance  or mixture, such as containment and 
measures to prevent fire as well as aerosol and dust generation;  
(b) prevent handling of incompatible substances or mixtures;  
(c) draw attention to operations and conditions which create new risks by altering 
the proper ties of the substance or mixture, and to appropriate countermeasures; 
and 
(d) reduce the release of the substance or mixture to the environment, such as 
avoiding spills or keeping away from drains.  
7.1.2.  Advice on general occupational hygiene shall be pro vided, such as:  
(a) not to eat, drink and smoke in work areas;  
(b) to wash hands after use; and  
(c) to remove contaminated clothing and protective equipment before entering 
eating areas.  
7.2. Conditions for safe storage, including any incompatibilities  
The advice provided shall be consistent with the physical and chemical properties described in 
section  9 of the safety data sheet. If relevant, advice shall be provided on specific storage 
requirements including:  
(a) how to manage risks associated with:  
(i) explosive atmospheres;  
(ii) corrosive conditions;  
(iii) flammability hazards;  
(iv) incompatible substances or mixtures;  
(v) evaporative conditions; and  
(vi) potential ignition sources (including electrical equipment);  
(b) how to control the effects of:  
(i) weather conditions;  
(ii) ambient pressure;  
(iii) temperature;  
(iv) sunlight;   
EN 14  EN (v) humidity; and  
(vi) vibration;  
(c) how to maintain the integrity of the substance or mixture by the use of:  
(i) stabilisers; and  
(ii) antioxidants;  
(d) other advice includi ng: 
(i) ventilation requirements;  
(ii) specific designs for storage rooms or vessels (including retention walls and 
ventilation);  
(iii) quantity limits under storage conditions (if relevant); and  
(iv) packaging compatibilities.  
7.3. Specific end use(s)  
For substances and mixtures designed for specific end use(s), recommendations shall relate to 
the identified use(s) referred to in subsection  1.2. and be detailed and operational. If an 
exposure scenario is attached, reference to it may be made or the informa tion as required in 
subsections  7.1. and 7.2. shall be provided. If an actor in the supply chain has carried out a 
chemical safety assessment for the mixture, it is sufficient that the safety data sheet and the 
exposure scenarios are consistent with the ch emical safety report for the mixture, rather than 
with the chemical safety reports for each substance in the mixture. If industry or sector 
specific guidance is available, detailed reference to it (including source and issuing date) may 
be made.  
 
8. SECTIO N 8: Exposure controls/personal protection  
This section of the safety data sheet shall describe the applicable occupational exposure limits 
and necessary risk management measures.  
Where a chemical safety report is required, the information in this section of the safety data 
sheet shall be consistent with the information given for the identified uses in the chemical 
safety report and the exposure scenarios showing control of risk from the chemical safety 
report set out in the annex to the safety data sheet.  
8.1. Control parameters  
8.1.1.  Where available, the following national limit values, including the legal basis of each 
of them, which are currently applicable in the Member State in which the safety data 
sheet is being provided shall be listed for the subs tance or for each of the substances in 
the mixture. When listing occupational exposure limit values, the chemical identity as 
specified in section  3 shall be used.  
8.1.1.1.  the national occupational exposure limit values that correspond to 
Union occupation al exposure limit valu es in accordance with 
Directive  98/24/EC, including any notations as referred to in 
Article  2(3) of Commission Decision  2014/113/EU (5); 
                                                 
5 OJ L 62, 4.3.2014 p.  18.  
EN 15  EN 8.1.1.2.  the national occupational exposure limit values that correspond to 
Union limit values in  accordance with Directive  2004/37/EC, including 
any nota tions as referred to in Article  2(3) of Decis ion 2014/113/EU;  
8.1.1.3.  any other national occupational exposure limit values;  
8.1.1.4.  the national biological limit values that correspond to Union bi ological 
limit valu es in accordance with Directive  98/24/EC, including any 
notations as referred to in  Article  2(3) of Decision  2014/113/EU;  
8.1.1.5.  any other national biological limit values.  
 
8.1.2.  Information on currently recommended monitoring proced ures shall be provided at 
least for the most relevant substances.  
8.1.3.  If air contaminants are formed when using the substance or mixture as intended, 
applicable occupational exposure limit values and/or biological limit values for these 
shall also be li sted. 
8.1.4.  Where a chemical safety report is required or where a DNEL as referred to in 
Section  1.4 of Annex  I or a  PNEC as referred to in Section  3.3 of Annex  I is available, 
the relevant DNELs and PNECs for the substance shall be given for the exposure  
scenarios from the chemical safety report set out in the annex to the safety data sheet.  
8.1.5.  Where a control banding approach is used to decide on risk management measures in 
relation to specific uses, sufficient detail shall be given to enable effecti ve 
management of the risk. The context and limitations of the specific control banding 
recommendation shall be made clear.  
8.2. Exposure controls  
The information required in this subsection shall be provided, unless an exposure scenario 
containing that inf ormation is attached to the safety data sheet.  
Where the supplier has waived a test  under Section  3 of Annex  XI, he shall indicate the 
specific conditions of use relied on to justify the waiving.  
Where a substance has been registered as an isolated interme diate (on -site or transported), the 
supplier shall indicate that this safety data sheet is consistent with the specific conditions 
relied on to justify the registra tion in accordance with Article  17 or 18.  
8.2.1. Appropriate engineering controls  
The descri ption of appropriate exposure control measures shall relate to the identified use(s) 
of the substance or mixtu re as referred to in subsection  1.2. This information shall be 
sufficient to enable the employer to carry out an assessment of risk to the safety and health of 
workers arising from the presence of the substance or mixture in acc ordance with Articles  4 to 
6 of Directive  98/24/EC and Articles  3 to 5 of Directive  2004/37/EC, where appropriate.  
This information shall complement t hat already given under section  7. 
8.2.2. Individual protection measures, such as personal protective equipment  
8.2.2.1.  The information on use of personal protective equipment shall be consistent 
with good occupational hygiene practices and in conjunction with other control 
measures, including engineering controls, ventilation and isolation. Where 
appropriate,  section  5 shall be referred to for specific fire/chemical personal 
protective equipment advice.   
EN 16  EN 8.2.2.2.  Taking into account Regulation (EU)  2016/425  of the European Pa rliament 
and of the Council6 and referring to the appropriate CEN standa rds, detailed 
specifications shall be given on which equipment will provide adequate and 
suitable protection , including:  
(a) Eye/face protection  
The type of eye/face protection equipment required shall be specified 
based on the hazard of the substance or mixture and potential for 
contact, such as safety glasses, safety goggles, face -shield.  
(b) Skin protection  
(i) Hand protection  
The type of gloves  to be worn when handling the substance or 
mixture shall be clearly specified based on the hazard of the 
substance or mixture and potential for contact and with regard 
to the amount and duration of dermal exposure, including:  
— the type of material and its  thickness,  
— the typical or minimum breakthrough times of the glove 
material,  
If necessary, any additional hand protection measures shall be 
indicated.  
(ii) Other  
If it is necessary to protect a part of the body other than the 
hands, the type and quality of protection equipment required 
shall be specified, such as gauntlets, boots, bodysuit based on 
the hazards associated with the substance or mixture and the 
potential for contact.  
If necessary, any additional skin protection measures and specific 
hygiene measures shall be indicated.  
(c) Respiratory protection  
For gases, vapours, mist or dust, the type of protective equipment to be 
used shall be specified based on the hazard and potential for exposure, 
including air -purifying respirators, specifying the pro per purifying 
element (cartridge or canister), the adequate particulate filters and the 
adequate masks, or self -contained breathing apparatus.  
(d) Thermal hazards  
When specifying protective equipment to be worn for materials that 
represent a thermal hazard , special consideration shall be given to the 
construction of the  personal protective equipment.  
8.2.3. Environmental exposure controls  
The information required by the employer to fulfil his commitments under Union 
environmental protection legislation shal l be specified.  
                                                 
6 Regulation (EU) 2016/425 of the European Parliament and of the C ouncil of 9 March 2016 on personal 
protective equipment and repealing Council Directive 89/686/EEC  (OJ L 81, 31.3.2016, p.  51).  
EN 17  EN Where a chemical safety report is required, a summary of the risk management measures that 
adequately control exposure of the environment to the substance shall be given for the 
exposure scenarios set out in the annex to the safety data she et. 
 
9. SECTION 9: Physical and chemical properties  
This section of the safety data sheet shall describe the empirical data relating to the substance 
or mixture, if relevant. Article  8(2) of Regulation (EC) No  1272/2008 shall apply.  
To enable proper control measures to be taken, all relevant information on the substance or 
mixture shall be provided. The information in this section shall be consistent with the 
information provided in the registration or in the chemical safety report , where required, and 
with the classification of the substance or mixture.  
In the case of a mixture, the entries shall clearly indicate to which substance in the mixture the 
data apply, unless it is valid for the whole mixture.  
Reported properties shall be cl early identified and reported in the appropriate measurement 
units. The method of determination shall be provided, including measurement and reference 
conditions, if relevant for the interpretation of the numerical value. Unless specified 
otherwise, standa rd conditions of temperature and pressure are 20  °C and 101,3  kPa, 
respectively.  
The properties listed  in subsections  9.1 and 9.2 may be presented in a form of  a list. The order 
of listing  the properties may be different  if deemed appropriate.  
9.1. Information on basic physical and chemical properties  
Each safety data sheet shall include t he properties mentioned below . If it is stated that a 
particular property does not apply or if information on a particular property is not available, 
this shall be clearly indicated, giving the reasons where possible.  
(a) Physical state   
The physical state (gas, liquid or solid) shall generally be indicated  at standard 
conditions of temperature and pressure.  
The definitions of the terms gas, liquid and solid, as prov ided in Section  1.0 of 
Annex  I to Regulation (EC) No  1272/2008, shall apply.  
(b) Colour  
The colour of the substance or mixture as supplied shall be indicated.  
In cases where one safety data sheet is used to cover variants of a mixture which may 
have differ ent colours, the term 'various' can be used to describe the colour.  
(c) Odour  
A qualitative description of the odour shall be given if it is well -known or describ ed in 
the literature.  
If available, the odour threshold shall be indicated (qualitatively or q uantitatively).  
(d) Melting point/freezing point  
Does not apply  to gases.  
Melting point  and freezing point  shall be indicated at standard pressure.   
EN 18  EN In case the melting point is above the measuring range of the method, it shall be 
indicated up to which temp erature  no melting point was observed.  
If decomposition or sublimation occur prior to or during melting , it shall be indicated . 
As regards  waxes and pastes, the softening point/range may be indicated instead  of the 
melting point  and freezing point . 
As rega rds mixtures, if it is technically not possible to determine the melting 
point/freezing point , this shall be indicated . 
(e) Boiling point or initial boiling point and boiling range  
These properties shall be  indicated at standard pressure. A boiling point a t lower 
pressure might however be indicated, in case the boiling point is very high or in case 
decomposition occurs before boiling at standard pressure.  
If the boiling point is above the measuring range of the method, the temperature up to 
which no boiling point w as observed shall be indicated.  
If decomposition occurs prior to or during boiling , this shall be indicated . 
As regards  mixtures, if it is technically not possible to determine the ir boiling point or 
range, this shall be indicated; in that case, the boiling point of the lowest boiling 
ingredient shall also be indicated.  
(f) Flammability  
Applies to gases, liquids and solids . 
It shall be indicated whether the substance or mixture is ignitable , i.e.  capable of 
catching fire or being set on fire, even if no t classified for flammability.  
If available and appropriate, further information may be indicated, such as wheth er the 
effect of ignition is other than a normal combustion (e.g. an explosion) and the 
ignitability under non -standard conditions.  
More specific  information on the flammability may be indicated based on the 
respective hazard classificatio n. The information provided in subsection 9.2 .1 shall not 
be provide d in this point.  
(g) Lower and upp er explosion limit7 
Do not apply  to solids.  
As regards  flammable liquids, at least the lower explosion limit shall be indicated . If 
the flash point is approximately  -25 °C or higher , it may not be possible to determine 
the upper explosion limit at standard temperature; in that case, it is recommended to 
indicate the upper explosion limit at a higher temperature.  If the flash point is higher 
than 20  °C, it may not be possible to determ ine the lower or the upper explosion limit 
at standard temperature; in that case, it is recommended to indicate both the lower and 
the upper explosion limit s at a higher temperature . 
(h) Flash point  
Does not apply  to gases, aerosols and solids.  
For mixture s, a value for the mixture shall be indicated , if available . Otherwise, the 
flash point(s) of the substance(s) with the lowest flash point(s) shall be indicated . 
                                                 
7 Note: The term “explosion limit” is synonymous to “flammability limit”, used outside the Union.   
EN 19  EN (i) Auto -ignition temperature  
Only applies  to gases and liquids.  
As regards  mixtures the auto -ignition temperature for the mixture shall be indicated , if 
available . If the value for the mixture is not available, the auto -ignition temperature(s) 
of the ingredients with the lowest auto -ignition temperature(s) shall be indicated.  
(j) Decomposition tem perature  
Only  appli es to self -reactive substances and mixtures, organic peroxides, and other 
substances and mixtures that may decompose.  
The self -accelerating decomposition temperature (SADT)  and the volume to which it 
applies, or the decomposition onset temperature shall be indicated.  
It shall be indicated whether the temperature given is the SADT or the decomposition 
onset temperature.  
If no decomposition was observed, it shall be indicated up to which temperature no 
decomposition was observed, e.g. “no decomposition observed up to x  °C”. 
(k) pH 
Does  not appl y to gases.  
The pH of the substance or mixture as supplied, or where the product is a solid, the pH 
of an aqueous liquid or solution at a given concentration, shall be indicated.  
The concentration of the test substance or mixture in water shall be indicated.  
(l) Kinematic viscosity  
Only applies  to liquids.  
The measurement unit shall be mm2/s. 
For non -Newtonian liquids, the thixotropic or rheopexic behaviour shall be indicated.  
(m) Solubility  
Solubility  shall generally  be indicated at standard temperature.  
The solubility in water shall be indicated.  
The solubility in other polar and non -polar solvents may also be included.  
As regards  mixtures, it shall be indicated if the mixture  is fully or only partially 
soluble in or miscible with water or other solvent.  
As regards  nanoforms, the dissolution rate in water or in other relevant biological or 
environmental media shall be indicated.  
(n) Partition coefficient n -octanol/water (log valu e) 
Does not appl y to inorganic and ionic liquids and does not  generally  apply to mixtures.  
It shall be indicated whether the reported value is based on testing or on calculation.  
As regards  nanoforms of a substance for which the n -octanol/water partition 
coefficient does not appl y, the dispersion stability in different media shall be 
indicated.  
(o) Vapour pressure  
Vapour pressure shall generally  be indicated at standard temperature.   
EN 20  EN As regards  volatile fl uids, the vapour pressure at 50  °C shall also be indi cated.  
In cases where one safety data sheet is used to cover variants of a liquid mixture or 
liquefied gas mixture, a range for the vapour pressure shall be indicated.  
As regards  liquid mixtures or liquefied gas mixtures, a range for the vapour pressure 
or at least the vapour pressure of the most volatile ingredient(s), where the vapour 
pressure of the mixture is predominantly determined by th at or those  ingredient(s), 
shall be in dicated.  
The saturated vapour concentration may  also be indicated.  
(p) Density and/or relative density  
Only apply to liquids and solids.  
Density and relative density  shall generally  be indicated at standard conditions of 
temperature and pressure.  
The absolute density and/or the relative density based on water at 4  °C as reference 
(also referred to as the specific gravity) shall be indicated.  
In cases where variations in density are possible, e.g. due to batch manufacture, or 
where one safety data s heet is used to cover several variants of a substance or mixture, 
a range may be indicated.  
The safety data sheet shall indicate whether the absolute density (units e.g. g/cm3 or 
kg/m3) and/or the relative  density (dimensionless) is being reported.  
(q) Relative vapour density  
Only applies  to gases and liquids.  
As regards  gases, the relative density of the gas based on air at 20  °C as reference shall 
be indicated.  
As regards  liquids, the relative vapour density based on air at 20  °C as reference shall 
be indicated.  
As regards liquids, the relative density Dm of the vapour/air -mixture at 20  °C may also 
be indicated.  
(r) Particle characteristics  
Only apply  to solids.  
The particle size (median equivalent diameter, method of calculation of the diameter 
(numbe r-, surface - or volume -based) and the range in which this median value varies), 
shall be indicated. Other  properties may also be indicated, such as size distribution 
(e.g. as a range), shape and aspect ratio, aggregation and agglomeration state, specific 
surface area and dustiness. If the substance is in nanoform or if the mixture supplied 
contains a nanoform,  th ose characteristics shall be indicated in this subsection, if not 
already specified elsewhere in th e safety data sheet.  
9.2. Other information  
In addition to the properties mentioned in subsection  9.1, other physical and chemical 
parameters shall be indicated, such as  the properties listed in subsections  9.2.1 . and 9.2.2 ., if 
their indication is relevant  for the safe use of the substance or mixtu re.  
9.2.1. Information with regard to physical hazard classes   
EN 21  EN This subsection lists properties, safety characteristics and test results , which may be use ful to 
include in the safety data sheet  when a substance or mixture is classified in the respective 
physical hazard class. Data deemed relevant with regard to a specific physical hazard but not 
resulting in classification (e.g. negative test results close to the criterion) , may also be 
appropriate to indicate .  
The name of the hazard class to which the dat a relate may be indicated together with the data.  
(a) Explosives  
This point  also appli es to substances and mixtures referred to in Note  2 of 
section  2.1.3 . of Annex  I of Regulation (EC) No  1272/2008, and to other substances 
and mixtures which show a positi ve effect if heated under confinement.  
The following information may be provided:  
(i) sensitivity to shock;  
(ii) effect of heating under confinement;  
(iii) effect of ignition under confinement;  
(iv) sensitivity  to impact;  
(v) sensitivity  to friction;  
(vi) thermal stability;  
(vii) package (type, size, net mass of substance or mixture), based on which the 
‘division ’ within the explosive class  was assigned, or based on which  the 
substance or mixture was exempted  from classification as explosive . 
(b) Flammable gases  
As regards  pure flammable gas, the following information may be provided in addition 
to data on the explosion limits referred to in point ( g) of  subsection  9.1.: 
(i) the TCi (maximum content of flammable gas which, when mixed with nitrogen, 
is not flammable in air, in mol.  %); 
(ii) the fundamental burning velocity if th e gas is classified as Category  1B based 
on fundamental burning velocity.  
As regards  a flammable gas mixture, the following information may be provided  in 
addition to data on the explosion limits referred to in point ( g) of subsection  9.1.: 
(i) explosion limits, if tested, or an indication of whether the classification and 
category assignment is based on calculation ; 
(ii) fundamental burning velocity if the gas mi xture is classifie d as Category  1B 
based on fundamental burning velocity.  
(c) Aerosols  
The following total percentage (by mass) of flammable components  may be provided , 
unless the aerosol is classified as Aeroso l category  1 because it contains more than 
1 % (by mass) flamma ble components or has a heat of combustion of at least 20 kJ/g 
and is not submitted to the flammability classification procedures (see the Note in 
Paragraph 2.3.2.2 of Annex I to Regulation (EC) No 1272/2008) ; 
(d) Oxidising gases   
EN 22  EN As regards  pure gas, the Ci (coefficient of oxygen equivalency)  as per ISO  10156  
‘Gases and gas mixtures - Determination of fire potential and oxidizing ability for the 
selection of cylinder valve outlets’ , or as per an equivalent method,  may be provided ; 
As regards  a gas mixture, the words "oxidising gas Category  1 (tested as per 
ISO 10156  (or as per an equivalent method) )" may be indicated as regards  tested 
mixtures, or the calculated oxidising power  as per ISO 10156  or as per ab equivalent 
method ; 
(e) Gases under pressure  
As rega rds pure gas, critical temperature may be provided.  
As regards  gas mixture, pseudo -critical temperature may be provided;  
(f) Flammable liquids  
When the substance or mixture is classified as flammable liquid, data on the boiling 
point and flash point do not need  to be provided under this point  as that data  are to be  
indicated in accordance with the  subsection  9.1. Information on sustained 
combustibility may be provided.  
(g) Flammable solids  
The following information may be provided:  
(i) burning rate , or burning time as regards  metal powders,  
(ii) statement on w hether the wetted zone has been passed;  
(h) Self-reactive substances and mixtures  
In addition to the indication of the SADT as specified in point (j) of subsection 9.1, the 
following information  may be provided:  
(i) decomposition temperature , 
(ii) detonation properties,  
(iii) deflagration properties,  
(iv) effect of heating under confinement,  
(v) explosive power, if applicable;  
(i) Pyrophoric liquids  
Information  on whether spontaneous ignition or charring of filter paper occurs may be 
provided . 
(j) Pyrophoric solids  
The following information may be provided:  
(i) statement on whether spontaneous ignition occurs when poured or within five 
minutes thereafter , as regards solids in powder form , 
(ii) statement on w hether pyrophoric properties could change  over time.  
(k) Self-heating substances and mixtures  
The following information may be provided:  
(i) statement on w hether spontaneous ignition occurs  and the maximum 
temperature rise obtained,   
EN 23  EN (ii) results of screenin g tests referred  to in section  2.11.4.2 of Annex  I to 
Regulation (EC) No  1272/2008, if relevant and available;  
(l) Substances and mixtures , which emit flammable gases  in contact with water  
The following information may be provided:  
(i) identity of the emitted gas, if known,  
(ii) statement on w hether the emitted gas ignites spontaneously,  
(iii) gas evolution rate ; 
(m) Oxidising liquids  
Information  on whether spontaneous ignition occurs when mixed with cellulose may 
be provided . 
(n) Oxidizi ng solids  
Information  on whether spontaneous ignition occurs when mixed with cellulose may 
be provided.  
(o) Organic peroxides  
In addition to the indication of the SADT as specified in point (j) of subsection 9.1, the 
following information  may be provided:  
(i) decomposition temperature , 
(ii) detonation properties,  
(iii) deflagration properties,  
(iv) effect of heating under confinement , 
(v) explosive power;  
(p) Corrosive to metals  
The following information may be provided:  
(i) metals  that are corroded by the substance or mixture,  
(ii.) corrosion rate and statement on whether it refers to steel or aluminium , 
(iii.) reference to other sections of the safety data sheet  with regard to compatible or 
incompatible materials.  
(q) Desensitised explosives  
The following information may be provided:  
(i) desensitising agent used,  
(ii) exothermic decomposition energy,  
(iii) corrected burning rate (Ac); 
(iv) explosive properties of the desensit ised explosive in that state . 
9.2.2. Other  safety characteristics  
Properties, safety characteristics and test results listed below may be useful to indicate  as 
regards  a substance or a mixture : 
(a) mechanical sensitivity ;  
EN 24  EN (b) self-accelerating polymerisation temperature ; 
(c) formation of explosible dust/air mixtures ; 
(d) acid/alkaline reserve ; 
(e) evaporation rate ; 
(f) miscibility;  
(g) conductivity;  
(h) corrosiveness;  
(i) gas group ; 
(j) redox potential;  
(k) radical formation potential;  
(l) photocatalytic properties . 
 
Other physical and chemical parameters shall be indicated if their indication is relevant for the 
safe use of the substance or mixture.  
 
10. SECTION 10: Stability and reactivity  
This section of the safety data sheet shall describe the stability of the substance or mixture and 
the possibility of hazardou s reactions occurring under certain conditions of use and also if 
released into the environment, including, where appropriate, a reference to the test methods 
used. If it is stated that a particular property does not apply or if information on a particular  
property is not available, the reasons shall be given.  
10.1. Reactivity  
10.1.1.  The reactivity hazards of the substance or mixture shall be described. Specific test data 
shall be provided for the substance or mixture as a whole, where available. However, 
the information may also be based on general data for the class or family of substance 
or mixture if such data adequately represent the anticipated hazard of the substance or 
mixture.  
10.1.2.  If data for mixtures are not available, data on substances in th e mixture shall be 
provided. In determining incompatibility, the substances, containers and contaminants 
that the substance or mixture might be exposed to during transportation, storage and 
use shall be considered.  
10.2. Chemical stability  
It shall be indicated if the substance or mixture is stable or unstable under normal ambient and 
anticipated storage and handling conditions of temperature and pressure. Any stabilisers 
which are, or may need to be, used to maintain the chemical stability of the subst ance or 
mixture shall be described. The safety significance of any change in the physical appearance 
of the substance or mixture shall be indicated . As regards  desensitised explosives, information 
on the shelf life and instructions on how to verify desensi tisation shall be provided, and it 
shall be indicated that removal of the desensitising agent will turn the product into an 
explosive.  
10.3. Possibility of hazardous reactions   
EN 25  EN If relevant, it shall be stated if the substance or mixture may react or polymer ise, releasing 
excess pressure or heat, or creating other hazardous conditions. The conditions under which 
the hazardous reactions may occur shall be described.  
10.4. Conditions to avoid  
Conditions such as temperature, pressure, light, shock, static discha rge, vibrations or other 
physical stresses that might result in a hazardous situation shall be listed (‘conditions to 
avoid’) and if appropriate a brief description of measures to be taken to manage risks 
associated with such hazards shall be given. As reg ards desensitised explosives, information 
on measures to be taken in order to avoid the unintentional removal of the desensitising agent 
shall be provided, and conditions to avoid shall be listed if the substance or mixture is not 
sufficiently desensitised.  
10.5. Incompatible materials  
Families of substances or mixtures or specific substances, such as water, air, acids, bases, 
oxidising agents, with which the substance or mixture could react to produce a hazardous 
situation (like an explosion, a  release of toxic or flammable materials, or a liberation of 
excessive heat), shall be listed and if appropriate a brief description of measures to be taken to 
manage risks associated with such hazards shall be given.  
10.6. Hazardous decomposition products  
Known and reasonably anticipated hazardous decomposition products produced as a result of 
use, storage, spill and heating shall be listed. Hazardous combustion products shall be 
included in section  5 of the safety data sheet.  
 
11. SECTION 11: Toxicologica l information  
This section of the safety data sheet is meant for use primarily by medical professionals, 
occupational health and safety professionals and toxicologists. A concise but complete and 
comprehensible description of the various toxicological (hea lth) effects and the available data 
used to identify those effects shall be provided, including where appropriate information on 
toxicokinetics, metabolism and distribution. The information in this section shall be consistent 
with the information provided in the registration and/or in the chemical safety report where 
required, and with the classification of the substance or mixture.  
11.1. Information on hazard  class es as defined  in Regulation (EC) No 1272/2008  
The relevant hazard classes, for which informat ion shall be provided, are:  
(a) acute toxicity;  
(b) skin corrosion/irritation;  
(c) serious eye damage/irritation;  
(d) respiratory or skin sensitisation;  
(e) germ cell mutagenicity;  
(f) carcinogenicity;  
(g) reproductive toxicity;  
(h) STOT -single exposure;  
(i) STOT -repeated exposure;   
EN 26  EN (j) aspiration hazard.  
These hazards shall always be listed on the safety data sheet.  
For substances subject to registration, brief summaries of the information derived from the 
application of Annexes  VII to XI shall be given, in cluding, where appropriate, a reference to 
the test methods used. For substances subject to registration, the information shall also include 
the result of the comparison of the available data with the criteria given in Regulation (EC) 
No 1272/2008 for CMR,  categories  1A and 1B, following point  1.3.1 of Annex  I to this 
Regulation.  
11.1.1. Information shall be provided for each hazard class or differentiation. If it is stated that 
the substance or mixture is not classified for a particular hazard class or dif ferentiation, the 
safety data sheet shall clearly state whether this is due to lack of data, technical impossibility 
to obtain the data, inconclusive data or data which are conclusive although insufficient for 
classification; in the latter case the safety data sheet shall specify “based on available data, the 
classification criteria are not met”.  
11.1.2. The data included in this subsection shall apply to the substance or mixture as placed 
on the market. In the case of a mixture, the data should describe the toxicological properties 
of the mixtur e as a whole, except if Article  6(3) of Regulation (EC) No  1272/2008 applies. If 
available, the relevant toxicological properties of the hazardous substances in a mixture shall 
also be provided, such as the LD50, a cute toxicity estimates or LC50.  
11.1.3. Where there is a substantial amount of test data on the substance or mixture, it may be 
necessary to summarise results of the critical studies used, for example, by route of exposure.  
11.1.4. Where the classificatio n criteria for a particular hazard class are not met, information 
supporting this conclusion shall be provided.  
11.1.5. Information on likely routes of exposure  
Information shall be provided  on likely routes of exposure and the effects of the substance or 
mixture via each possible route of exposure, that is, through ingestion (swallowing), 
inhalation or skin/eye exposure. If health effects are not known, this shall be stated.  
11.1.6. Symptoms  related to the physical, chemical and toxicological characteristics  
Potential adverse health effects and symptoms associated with exposure to the substance or 
mixture and its ingredients or known by -products shall be described. Available information 
shall  be provided on the symptoms related to the physical, chemical, and toxicological 
characteristics of the substance or mixture following exposure. The first symptoms at low 
exposures through to the consequences of severe exposure shall be described, such as  
“headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses 
may result in coma and death”.  
11.1.7. Delayed and immediate effects as well as chronic effects from short and long -term 
exposure  
Information shall be provided on w hether delayed or immediate effects can be expected after 
short or long -term exposure. Information on acute and chronic health effects relating to 
human exposure to the substance or mixture shall also be provided. Where human data are not 
available, animal  data shall be summarised and the species clearly identified. It shall be 
indicated whether toxicological data is based on human or animal data.  
11.1.8. Interactive effects  
Information on interactions shall be included if relevant and available.   
EN 27  EN 11.1.9. Absence of specific data  
It may not always be possible to obtain information on the hazards of a substance or mixture. 
In cases where data on the specific substance or mixture are not available, data on similar 
substances or mixtures, if appropriate, may be used, provided the relevant similar substance or 
mixture is identified. Where specific data are not used, or where data are not available, this 
shall be clearly stated.  
11.1.10. Mixtures  
For a given health effect, if a mixture has not been tested for its h ealth effects as a whole, 
relevant information on relevant substances listed under section  3 shall be provided.  
11.1.11. Mixture versus substance information  
11.1.11.1.  The substances in a mixture may interact with each other in the body, resulting 
in diff erent rates of absorption, metabolism and excretion. As a result, the toxic 
actions may be altered and the overall toxicity of the mixture may be different 
from that of the substances in it. This shall be taken into account when 
providing toxicological inf ormation in this subsection of the safety data sheet.  
11.1.11.2.  It is necessary to consider whether the concentration of each substance is 
sufficient to contribute to the overall health effects of the mixture. The 
information on toxic effects shall be pre sented for each substance, except for 
the following cases:  
(a) if the information is duplicated, it shall be listed only once for the 
mixture overall, such as when two substances both cause vomiting and 
diarrhoea;  
(b) if it is unlikely that these effects w ill occur at the concentrations 
present, such as when a mild irritant is diluted to below a certain 
concentration in a non -irritant solution;  
(c) where information on interactions between substances in a mixture is 
not available, assumptions shall not be m ade and instead the health 
effects of each substance shall be listed separately.  
11.2 Information on other hazards   
11.2.1. Endocrine disrupting properties  
Information on adverse health effects caused by endocrine disrupting properties  shall be 
provided , where available , for the substances identified as having endocrine disrupting 
properties in Subs ection 2.3 . This information shall consist of  brief summaries of the 
information derived from application of the assessment criteria laid down in the  
corresponding Regulation s ((EC)  No 1907/2006, (EU)  2017/2100, (EU)  2018/605) , that is  
relevant to assess endocrine disrupting properties  for human health . 
11.2.2. Other information  
Other relevant information on adverse health effects shall be included even  when not required 
by the  classification criteria.  
 
12. SECTION 12: Ecological information  
This section of the safety data sheet shall provide information to enable evaluation of the 
environmental impact of the substance or mixture where it is released to the environment.  
EN 28  EN Subsections  12.1. to 12.6. of the safety data sheet shall provide a short summary of the data 
including, where available, relevant test data and clearly indicating species, media, units, test 
duration and test conditions. This information may assist in handling spills, and evaluating 
waste treatment practices, control of release, accidental release measures and transport. If it is 
stated that a particular property does not apply (because the available data shows that the 
substance or mixtur e does not meet the criteria for classification) or if information on a 
particular property is not available, the reasons shall be indicated. Additionally, if a substance 
or mixture is not classified for other reasons (for example, due to the technical imp ossibility 
of obtaining the data or to inconclusive data) this should be clearly stated on the safety data 
sheet.  
Some properties are substance specific, i.e. bioaccumulation, persistence and degradability, 
and that information shall be given, where availa ble and appropriate, for each relevant 
substance in the mixture (i.e. those which are required to be listed in section  3 of the safety 
data sheet and are hazardous to the environment or PBT/vPvB - substances). Information shall 
also be provided for hazardo us transformation products arising from the degradation of 
substances and mixtures.  
The information in this section shall be consistent with the information provided in the 
registration and/or in the chemical safety report where required, and with the clas sification of 
the substance or mixture.  
Where reliable and relevant experimental data are available, that data shall be provided and 
take precedence  over information obtained from models.  
12.1. Toxicity  
Information on toxicity using data from tests perform ed on aquatic and/or terrestrial 
organisms shall be provided when available. This shall include relevant available data on 
aquatic toxicity, both acute and chronic for fish, crustaceans, algae and other aquatic plants. In 
addition, toxicity data on soil mi cro- and macroorganisms and other environmentally relevant 
organisms, such as birds, bees and plants, shall be included when available. Where the 
substance or mixture has inhibitory effects on the activity of microorganisms, the possible 
impact on sewage t reatment plants shall be mentioned.  
Where experimental data are not available, the supplier  shall consider whether reliable and 
relevant information obtained from model s can be provided.  
For substances subject to registration, summaries of the information derived from the 
application of Annexes  VII to XI of this Regulation shall be included.  
12.2. Persistence and degradability  
Degradability is the potential for the substance or the appropr iate substances in a mixture to 
degrade in the environment, either through biodegradation or other processes, such as 
oxidation or hydrolysis. Persistence is the lack of demonstration of degradation in the 
situations  defined in  Sections 1.1.1 and 1.2.1  of Annex  XIII. Test results relevant to assess 
persistence and degradability shall be given where available. If degradation half -lives are 
quoted it must be indicated whether these half -lives refer to mineralisation or to primary 
degradation. The potential of  the substance or certain substances in a mixture to degrade in 
sewage treatment plants shall also be mentioned.  
Where experimental data are not available, the supplier shall consider whether reliable and 
relevant information obtained from model s can be pr ovided.  
This information shall be given where available and appropriate, for each individual substance 
in the mixture , which is required to be listed in section  3 of the safety data sheet.   
EN 29  EN 12.3. Bioaccumulative potential  
Bioaccumulative potential is the po tential of the substance or certain substances in a mixture 
to accumulate in biota and, eventually, to pass through the food chain. Test results relevant to 
assess the bioaccumulative potential shall be given. This shall include reference to the 
octanol -water partition coefficient (K ow) and bioconcentration factor (BCF), or other re levant  
parameters  related to bioaccumulation , if available.  
Where experimental data are not available, it shall be considered whether model predictions 
can be provided.  
This info rmation shall be given where available and appropriate, for each individual substance 
in the mixture which is required to be listed in section 3 of the safety data sheet.  
12.4. Mobility in soil  
Mobility in soil is the potential of the substance or the comp onents of a mixture, if released to 
the environment, to move under natural forces to the groundwater or to a distance from the 
site of release. The potential for mobility in soil shall be given where available. Information 
on mobility in soil can be determ ined from relevant mobility data such as adsorption studies 
or leaching studies, known or predicted distribution to environmental compartments, or 
surface tension. For example, soil adsorption coefficient (Koc) values can be predicted from 
Kow. Leaching an d mobility can be predicted from models.  
This information shall be given where available and appropriate, for each individual substance 
in the mixture which is required to be listed in section 3 of the safety data sheet.  
12.5. Results of PBT and vPvB  assessment  
Where a chemical safety report is required, the results of the PBT and vPvB assessment as set 
out in the chemical safety report shall be given.  
12.6. Endocrine disrupting properties  
Information on adverse effects on the environment caused by endocrine disrupting properties 
shall be provided where available , for the substances identified as having endocrine disrupting 
properties in subsection 2.3 . This information shall consist of  brief summaries of the 
information derived from application of the assessment criteria laid down in the 
corresponding Regulation s ((EC)  No 1907/2006, (EU)  2017/2100, (EU)  2018/605),  that is  
relevant to assess endocrine disrupting properties  for the environment . 
12.7. Other adverse effects  
Information on any other adverse effects on the environment shall be included where 
available, such as environmental fate (exposure), photochemical ozone creation potential, 
ozone depletion potential or global warming potentia l. 
 
13. SECTION 13: Disposal considerations  
This section of the safety data sheet shall provide information for proper waste management 
of the substance or mixture and/or its container to assist in the determination of safe and 
environmentally preferred wa ste management options, consistent with the requirements of 
Directive  2008/98/EC of the European Parliament and of the Council (8) by the Member State 
in which the safety data sheet is being supplied. Information relevant for the safety of persons 
conducti ng waste management activities shall complement the information given in section  8. 
                                                 
8 OJ L 312, 22.11.2008, p.  3.  
EN 30  EN Where a chemical safety report is required and where a waste stage analysis has been 
performed, the information on the waste management measures shall be consistent with th e 
identified uses in the chemical safety report and the exposure scenarios from the chemical 
safety report set out in the annex to the safety data sheet.  
13.1. Waste treatment methods  
This subsection of the safety data sheet shall:  
(a) specify  waste treatment containers and methods including the appropriate methods of 
waste treatment of both the substance or mixture and any contaminated packaging (for 
example, incineration, recycling, landfilling);  
(b) specify the physical/chemical properties t hat may affect waste treatment options;  
(c) discourage sewage disposal;  
(d) identify, where appropriate, any special precautions for any recommended waste 
treatment option.  
Any relevant Union provisions relating to waste or, in their absence, any relevant national or 
regional provisions in force shall be referred to.  
 
14. SECTION 14: Transport information  
This section of the safety data sheet shall provide basic classification information for the 
transport/shipment of substances o r mixtures mentioned in section 1 by road, rail, sea, inland 
waterways or air. Where such information is not available or relevant this shall be stated.  
Where relevant, this section shall provide information on the transport classification for each 
of the following international agr eements which are transposing the UN Model Regulations 
for specific transport modes: the European Agreement concerning the International Carriage 
of Dangerous Goods by Road (ADR), the Regulations concerning the International Carriage 
of Dangerous Goods by Rail (RID) and the European Agreement concerning the International 
Carriage of Dangerous Goods by Inland Waterways (ADN), all three of which hav e been 
implemented by Directive  2008/68/EC of the European Parliament and of the Council (9), as 
well as the Int ernational Maritime Dangerous Goods (IMDG)  Code (10) for the transport of 
packaged goods and the relevant IMO codes for the transport of bulk cargo by sea (11) and the 
Technical Instructions for the Safe Transport of Danger ous Goods by Air (ICAO TI) (12). 
14.1. UN number  
The UN number (i.e. the four -figure identification number of the substance, mixture or article 
preceded by the letters “UN”) from the UN Model Regulations shall be provided.  
                                                 
9 Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the 
inland transport of dangerous goods  (OJ L  260, 30.9.2008, p.  1). 
10 Compliance with the IMDG Code is mandatory for the carriage of packaged dangerous goods by s ea as 
provided for in  Chapter VII/ Reg. 3 of SOLAS and MARPOL Annex III Prevention of Pollution by 
Harmful Substances Carried by Sea in Packaged Form.  
11 The IMO has developed various legal instruments related to dangerous and polluting goods 
differentiatin g between how the goods are carried (packaged and bulk) and by type of cargo (solid, 
liquid and liquefied gases). Rules on  the carriage of dangerous cargoes and the ships that carry these 
cargoes are found in the International Convention for the Safety of Life at Sea (SOLAS, 1974), as 
amended, and the International Convention on Maritime Pollution (MARPOL 73/78), as amended. 
These conventions are supplemented by the following codes: IMDG, IMSBC, IBC and IGC.  
12 IATA, 2007 -2008 edition.   
EN 31  EN 14.2. UN proper shipping name  
The UN proper ship ping name as provided in column  2, ‘Name and description’, of Table  A 
of Chapter  3.2 Dangerous Goods List of the UN Model Regulations shall be provided, unless 
it was used as the product identifier in subsection  1.1. As regards  inland transport, the UN 
proper shipping name entr y shall contain the name and description of the substance to be  
transport ed, as provided in column  2 ‘Name and description’ of  Table A of Chapter  3.2 
Dangerous Goods List of ADR, RID and ADN. As regards  maritime transport , in addition to 
the UN proper ship ping name, the technical name for goods to be transported covered by the  
IMDG Code  shall be indicated, where appropriate . 
14.3. Transport hazard class(es)  
The transport hazard class (and subsidiary risks) assigned to the substances or mixtures on the 
basis  of the predominant hazard that they present according to the UN Model Regulations 
shall be provided. As regards  inland transport, the transport hazard class (and subsidiary risks) 
assigned to the substances or mixtures on the basis of the predominant haza rd that they 
present according to ADR, RID and ADN shall be provided . 
14.4. Packing group  
The packing group number from the UN Model Regulations shall be provided, if applicable. 
The packing group number is assigned to certain substances in accordance with  their degree 
of hazard.  
14.5. Environmental hazards  
It shall be indicated whether the substance or mixture is environmentally hazardous according 
to the criteria of the UN Model Regulations  (as reflected  ADR, RID and ADN), and  whether 
it is a marine pollutant according to the IMDG Code and the Emergency Response Procedures 
for Ships Carrying Dangerous Goods. If the substance or mixture is authorised or intended for 
carriage by inland waterways in tank -vessels, it shall be indicated  whether th e substance or 
mixture is environmentally hazardous in tan k-vessels only according to ADN.  
14.6. Special precautions for user  
Information shall be provided on any special precautions, which a user should or must take or 
be aware of in connection with trans port or conveyance either within or outside his premises , 
for all relevant modes of transport.   
14.7. Maritime transport in bulk according to IMO instruments  
This subsection only applies when cargoes are intended to be carried in bulk according to 
IMO inst ruments: Chapter  VI or Chapter VII of SOLAS (13), Annex  II or Annex  V of 
MARPOL, the IBC Code (14), the IMSBC Code (15), and the IGC Code (16) or its earlier 
versions, namely  EGC Code (17) or GC Code (18)). 
                                                 
13 SOLAS means the Inte rnational Convention for the Safety of Life at Sea, 1974, as amended.  
14 IBC Code means the International Code for the Construction and Equipment of Ships carrying 
dangerous Chemicals in Bulk , as amended.  
15 IMSBC Code means the International Maritime Solid Bulk Cargoes Code, as amended.  
16 IGC Code means the International Code for the Construction and Equipment of Ships Carrying 
Liquefied Gases in Bulk, including applicable amendments in accordance with which  the vessel has 
been certified.  
17 EGC Code means th e Code for Existing Ships Carrying Liquefied Gases in Bulk , as amended . 
18 GC Code means the Code for the Construction and Equipment of Ships Carrying Liquefied Gases in 
Bulk (Gas Carrier Code) , as amended .  
EN 32  EN As regards  liquid bulk cargoes, the product name shall be provided (if differen t from that 
given in subsection  1.1.) as required by the shipment document and in accordance with the 
name used in the lists of product names given in chapters  17 or 18 of the IBC Code or the 
latest edition of the IMO’s Maritime Env ironment Protection Committee (MEPC).2/Circular 
(19). Ship type required and pollution category shall be indicated , as well as the IMO hazard 
class, in accordance with Annex I  (3) B (a)  of D irective 2002 /59/EC of the European 
Parliament and of the Council20. 
As regards  solid bulk cargoes, the bulk cargo shipping name shall be provided. It shall be 
indicated whether or not the cargo is considered  harmful to the marine environment (HME) 
according to Annex  V of MARPOL , whether it is a material hazardous only in bulk (MHB) 
(21) according to the IMSBC Code, and as which cargo group it should be considered 
according to the IMSBC.  
As regards  liquefied gas cargoes in bulk, the product name and the ship type required 
according to the IGC Code or  its earlier versions , namely  EGC Code or GC Code shall be 
provided.  
 
15. SECTION 15: Regulatory information  
This section of the safety data sheet shall describe the other regulatory information on the 
substance or mixture that is not already provided in the safety data sheet (suc h as whether the 
substance or mixture i s subject to Regulation (EC) No  1005/2009 of the European Parliament 
and of the Council of 16 September 2009 on substances  that deplete the ozone layer (22), 
Regulation (EC) No  850/2004 of the European Parliament and o f the Council of 29 April 
2004 on persistent organic pollutants and amending Directive  79/117/EE C (23) or Regulation 
(EC) No  649/2012 of the European Parliament and of the Council of 4 July 2012 concerning 
the export and import of dangerous chemicals (24)). 
15.1. Safety, health and environmental regulations/legislation specific for the substance 
or mixture  
Information shall be provided regarding relevant Union safety, health and environmental 
provisions (for example, Seveso category/named substances in Annex  I to Council 
Directive  96/82/EC (25)) or regarding the national regulatory status of the substance or 
mixture (including the substances in the mixture), including advice on action that should be 
taken by the recipient as a result of these provisions. Where  relevant the national laws of the 
relevant Member States which implement these provisions and any other national measures 
that may be relevant shall be mentioned.   
If the substance or mixture covered by this safety data sheet is the subject of specific 
provisions in relation to the protection of human health or the environment at Union level 
(such as a uthorisations given under Title  VII or restrictions under Title  VIII) these provisions 
                                                 
19 MEPC.2/Circular, Provisional categorisation of l iquid substances, version 19, effective 17 December 
2013.  
20 Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a 
Community vessel traffic monitoring and information system and repealing Council Directive 
93/75/E EC (OJ L 208, 5.8.2002, p. 10 ). 
21 Materials hazardous only in bulk (MHB) means materials which may possess chemical hazards when 
carried in bulk other than materials classified as dangerous goods in the IMDG Code.  
22 OJ L 286, 31.10.2009, p. 1.  
23 OJ L  158, 30.4.2004, p.  7 
24 OJ L  201, 27.7.2012, p.  60. 
25 OK L  10, 14.1.1997, p.  13.  
EN 33  EN shall be mentioned.  Where an authorisation granted under Title  VII imp oses conditions or 
monitoring arrangements to a downstream user of the substance or mixture, they shall be 
provided.  
15.2. Chemical safety assessment  
This subsection of the safety data sheet shall indicate whether the supplier has carried out a 
chemical sa fety assessment for the substance or the mixture.  
 
16. SECTION 16: Other information  
This section of the safety data sheet shall contain other information that is not included in 
sections  1 to 15, including information on the revision of the safety data sh eet such as:  
(a) in the case of a revised safety data sheet, a clear indication of where changes have 
been made to the previous version of the safety data sheet, unless such indication is 
given elsewhere in the safety data sheet, with an explanation of the  changes, if 
appropriate. A supplier of a substance or mixture shall be able to provide an 
explanation of the changes upon request;  
(b) a key or legend to abbreviations and acronyms used in the safety data sheet;  
(c) key literature references and sources f or data;  
(d) in the case of mixtures, an indication of which of the methods of evaluating 
information referred to in Article  9 of Regulation (EC) No  1272/2008 was used for the 
purpose of classification;  
(e) a list of relevant hazard statements and/or preca utionary statements. Write out the full 
text of any statements , which are not written out in full under sections  2 to 15;  
(f) advice on any training appropriate for workers to ensure protection of human health 
and the environment.  
 
PART B  
 
The safety data sheet shall include the following 16 headings in accordance with Article  31(6) 
and in addition the subheadings also listed except section  3, where only subsection  3.1. or 
subsection 3.2. need s to be included as appropriate:  
SECTION 1: Ident ification of the substance/mixture and of the company/undertaking  
1.1. Product identifier  
1.2. Relevant identified uses of the substance or mixture and uses advised against  
1.3. Details of the supplier of the safety data sheet  
1.4. Emergency telephone numb er 
SECTION 2: Hazards identification  
2.1. Classification of the substance or mixture  
2.2. Label elements  
2.3. Other hazards  
SECTION 3: Composition/information on ingredients   
EN 34  EN 3.1. Substances  
3.2. Mixtures  
SECTION 4: First aid measures  
4.1. Description of fi rst aid measures  
4.2. Most important symptoms and effects, both acute and delayed  
4.3. Indication of any immediate medical attention and special treatment needed  
SECTION 5: Firefighting measures  
5.1. Extinguishing media  
5.2. Special hazards arising from th e substance or mixture  
5.3. Advice for firefighters  
SECTION 6: Accidental release measures  
6.1. Personal precautions, protective equipment and emergency procedures  
6.2. Environmental precautions  
6.3. Methods and material for containment and cleaning up  
6.4. Reference to other sections  
SECTION 7: Handling and storage  
7.1. Precautions for safe handling  
7.2. Conditions for safe storage, including any incompatibilities  
7.3. Specific end use(s)  
SECTION 8: Exposure controls/personal protection  
8.1. Control par ameters  
8.2. Exposure controls  
SECTION 9: Physical and chemical properties  
9.1. Information on basic physical and chemical properties  
9.2. Other information  
SECTION 10: Stability and reactivity  
10.1.  Reactivity  
10.2.  Chemical stability  
10.3.  Possibility of  hazardous reactions  
10.4.  Conditions to avoid  
10.5.  Incompatible materials  
10.6.  Hazardous decomposition products  
SECTION 11: Toxicological information  
11.1.  Information on hazard classes as defined in  Regulation (EC) No 1272/2008  
11.2  Information on ot her hazards   
EN 35  EN SECTION 12: Ecological information  
12.1.  Toxicity  
12.2.  Persistence and degradability  
12.3.  Bioaccumulative potential  
12.4.  Mobility in soil  
12.5.  Results of PBT and vPvB assessment  
12.6.  Endocrine disrupting properties  
12.7. Other  adverse effects  
SECTION 13: Disposal considerations  
13.1.  Waste treatment methods  
SECTION 14: Transport information  
14.1.  UN number  
14.2.  UN proper shipping name  
14.3.  Transport hazard class(es)  
14.4.  Packing group  
14.5.  Environmental hazards  
14.6.  Specia l precautions for user  
14.7.  Maritime t ransport in bulk according to IMO instruments  
SECTION 15: Regulatory information  
15.1.  Safety, health and environmental regulations/legislation specific for the substance or 
mixture  
15.2.  Chemical safety assessment  
SECTION 16: Other information’