EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
  
Brussels, …. 
xxx 
Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
on the Registration, Evaluation, Authorisat ion and Restriction of Chemicals (REACH) EN 2   EN Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council 
on the Registration, Evaluation, Authorisat ion and Restriction of Chemicals (REACH) 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council  Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as  well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
131 thereof, 
Whereas: (1) Safety data sheets have been a well-accepted and effective method for the provision of 
information on substances and mixtures in  the Community and have been made an 
integral part of the system  of Regulation (EC) No 1907/2006. 
(2) With a view to facilitating worldwide tr ade while protecting human health and the 
environment, harmonised criteria for classi fication and labelling and rules for safety 
data sheets have been carefu lly developed over a period of more than 10 years within 
the United Nations (UN) structure, resultin g in the Globally Harmonised System of 
Classification and Labelling of Chemicals (h ereinafter referred to as ‘the GHS’). 
(3) Regulation (EC) No 1272/2008 of the European  Parliament and of the Council of 16 
December 2008 on classification, labelling and packaging of substances and mixtures, 
amending and repealing Directives 67/ 548/EEC and 1999/45/EC, and amending 
Regulation (EC) No 1907/2006
2 harmonises the provisions and criteria for the 
classification and labelling of substances, mi xtures and certain specific articles within 
the Community, taking into accoun t the classification criteria and labelling rules of the 
GHS. 
                                                 
1 OJ L 396, 30.12.2006, p. 1; corrected by OJ L 136, 29.5.2007, p. 3.  
2 OJ L 353, 31.12.2008, p. 1. EN 3   EN (4) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, 
regulations and administrative provisions re lating to the classification, packaging and 
labelling of dangerous substances3 and Directive 1999/45/EC of the European 
Parliament and of the Council of 31 May 1999 concerning the approximation of the 
laws, regulations and administ rative provisions of the Memb er States relating to the 
classification, packaging and labe lling of dangerous preparations4 were amended 
several times and will be repealed and replaced by Regulation (EC) No 1272/2008 with effect from 1 December 2010 and 1 June 2015, respectively. 
(5) Therefore Annex II to Regulation (EC) No  1907/2006 should be amended to adapt it 
to the criteria for classification and other relevant provisions laid down in Regulation 
(EC) No 1272/2008. 
(6) The requirements for safety data sheets laid  down in Annex II to Regulation (EC) No 
1907/2006 should moreover be adapted taking in to account the rules for safety data 
sheets of the GHS, in order to allow th e threefold mechanism of classification, 
labelling and safety data shee ts to fulfil its role  through interaction of its component 
parts. 
(7) Safety data sheets thus amended should con tinue to be an important element of hazard 
communication and provide a mechanism for transmitting appropriate safety information on substances and mixtures m eeting the criteria for classification in 
accordance with applicable Community legisl ation, as well as certa in substances and 
mixtures not meeting those criteria, taking in to account informati on from any relevant 
chemical safety report, down the supply chain to the immediate downstream user. 
(8) The application of the safety data sheet re quirements for substan ces and mixtures, as 
amended by this Regulation, should follo w the staggered application of the 
classification and labelling provi sions for substances and mixtures in accordance with 
Regulation (EC) No 1272/2008. Th erefore, and because the classification and hazard 
communication for mixtures depends on the classification and h azard communication 
for substances, the safety data sheet require ments for mixtures should only be applied 
after the safety data sheet requirements for substances. 
(9) Suppliers of mixtures choosing to rely on the possibility to  apply, on a vol untary basis, 
both the classification and the labelling in accordance with Regulation (EC) No 1272/2008 earlier than 1 June 2015 should provide in the relevant safety data sheet the 
classification in accordance with Regulati on (EC) No 1272/2008 together with the 
classification in accordance with Directive 1999/45/EC. 
(10) Safety data sheets for substances providing classification and labelling information in 
accordance with Regulation (EC) No 1272/2008 should, before 1 June 2015, be required to provide classi fication information in accordance with Directive 
67/548/EEC as well, in order to allow s uppliers of mixtures  not relying on the 
possibility to apply both the classificat ion and the labelling in accordance with 
Regulation (EC) No 1272/2008 ear lier, to classify and label those mixtures correctly. 
                                                
 
3 OJ 196, 16.8.1967, p. 1. 
4 OJ L 200, 30.7.1999, p. 1. EN 4   EN (11) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Regulation (EC) No 1907/2006 is amended as follows: 
(1) with effect from 1 December 2010: 
(a) Annex II is replaced by A nnex I to this Regulation; 
(b) in Section 3.7 of Annex VI, in the title, the words “(see Safety Data Sheet 
heading 16)” are replaced by “(see Sec tion 1 of the safety data sheet)”; 
(2) with effect from 1 June 2015, Annex II to  Regulation (EC) No  1907/2006 is replaced 
by Annex II to this Regulation. 
Article 2 
1. Until 1 December 2010, suppliers of substanc es applying Article 61(2) of Regulation 
(EC) No 1272/2008 may apply Annex II to Regulation (EC) No 1907/2006, as amended by point 1 of Arti cle 1 of this Regulation. 
2. Until 1 June 2015, suppliers of mixtures a pplying Article 61(2) of Regulation (EC) 
No 1272/2008 may apply Annex II to Regulation (EC) No 1907/2006, as amended by point 2 of Article 1 of this Regulation. 
3. Until 1 June 2015, suppliers of mixtures applying paragraph 2 shall provide in 
Subsection 3.2 of the relevant safety data sheets the cla ssification of the substances 
indicated in that subsecti on in accordance with Dire ctive 67/548/EEC, including 
indication of danger, symbol letter(s) and R phrases, in addition to the classification 
and labelling in accordance with Regulation (EC) No 1272/2008. 
4. Until 1 June 2015, suppliers of mixtures applying paragraph 2 shall provide in 
Subsection 2.1 of the relevant safety data sh eets the classificati on of the mixture in 
accordance with Directive 1999/45/EC in additi on to the classification in accordance 
with Regulation (EC) No 1272/2008. 
Until 1 June 2015, suppliers of mixtures meet ing the criteria for classification in 
accordance with Regulation (EC) No 1272/2008 shall, when applying paragraph 2, 
indicate the substances presenting a heal th or environmental hazard within the 
meaning of Directive 67/548/EEC  in subsection 3.2 of the rele vant safety data sheets 
if those substances are present in concentratio ns equal to or greater than the lowest of 
the values listed in point 3.2.1.(a) of Anne x II to this Regulation in addition to the 
substances mentioned in point 3.2.1. of that Annex. 
Until 1 June 2015, suppliers of mixtures not meeting the criteria for classification in 
accordance with Regulation (EC) No 1272/2008 shall, when applying paragraph 2, 
indicate the substances presenting a heal th or environmental hazard within the EN 5   EN meaning of Directive 67/548/EEC  in subsection 3.2 of the rele vant safety data sheets 
if those substances are present in an indivi dual concentration equal to or greater than 
1% by weight in non-gaseous mixtures a nd 0,2% by volume in gaseous mixtures in 
addition to the substances mentioned in point 3.2.2 of Annex II to this Regulation. 
Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, […] 
 For the Commission 
 Member of the Commission EN 6   EN ANNEX I   
'ANNEX II  
REQUIREMENTS FOR THE COMPILAT ION 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 mixtur e in accordance with 
Article 31. 
0.1.2. The information provided in the safety data sheet shall be consistent with the 
information in the chemical safety report,  where one is 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. 
0.2. General requirements for comp iling 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, handl ing and disposal of the substance or the 
mixture. 
0.2.2. The information provided by safety data sh eets shall also meet the requirements set 
out in Council Directive 98/24/ EC. In particular, the safety data sheet shall enable 
employers to determine whether any hazardou s chemical agents are present in the 
workplace, and to assess any risk to the he alth 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 competent person who shall take into account the specific needs and know ledge of the user audience, as far as 
they are known. Suppliers of  substances and mixtures shall ensure that such 
competent persons have received appropr iate training, includi ng refresher training. 
0.2.4. The language used in the sa fety data sheet shall be simple, clear and precise, 
avoiding jargon, acronyms a nd 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 subs tance 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 da ta sheet shall be given on the first page. 
When a safety data sheet has been revised and the new, revised ve rsion is provided to 
recipients, the changes shall be brought to th e attention of the reci pient in Section 16 
of the safety data sheet, unl ess they have been indicated elsewhere. In that case, the 
date of compilation identified as “Revision: (date)” as well as a version number, EN 7   EN revision number, supersedes date or other i ndication of what version is replaced shall 
appear on the first page. 
0.3. Safety data sheet format 
0.3.1. A safety data sheet is not a fixed length doc ument. 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 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 “Continue d on next page” or “End of safety data 
sheet”). 
0.4. Safety data sheet content 
The information required by this  Annex shall be included in the safety data sheet, 
where applicable and available, under the re levant subsections set out in Part B. The 
safety data sheet shall no t contain blank subsections. 
0.5. Other information requirements 
The inclusion of additional relevant and available information under the relevant 
subsections may be necessary in some cases in view of the wide  range of properties 
of substances and mixtures. 
0.6. Units 
The units of measurement as set out in Council Directive 80/181/EEC5 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 prescribes 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 substa nce or mixture including an 
emergency contact shall be provide d in the safety data sheet. 
1.1. Product identifier 
In the case of a substance, the product identifier shall be provided in accordance with 
Article 18(2) of Regulati on (EC) No 1272/2008 and as pr ovided on the label in the 
official language(s) of the Member Stat e(s) where the substance is placed on the 
market, unless the Member State(s)  concerned provide(s) otherwise. 
                                                 
5 OJ L 39, 15.2.1980, p. 40. EN 8   EN For substances subject to registration, the pr oduct 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 indi cated. 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) that supplier assumes the responsibil ity to provide the fu ll registration number 
upon request to the recipient and any furthe r recipients down the supply chain within 
7 calendar days of the receipt of the request , or, if the full registration number is not 
available to him, a copy of the request to his supplier to provide the full registration 
number within 7 calendar days of the receipt of the request; and  
(b) that supplier provides the full registra tion number to the Member State authorities 
responsible for enforcement upon request w ithin 7 calendar days . This deadline is 
prolonged by further 7 calendar days for each additional actor in the supply chain 
who needs to be consulted. In case an actor in the supply chain fails  to answer within 
this deadline, this supplie r provides the relevant corre spondence, including the name 
and contact details of the actor in the supply chain who failed to answer the 
correspondence, to the Member State auth orities responsible for enforcement. 
In the case of a mixture, the trade name  or designation shall be provided in 
accordance with Article 10(2.1) of Directive 1999/45/EC and of the substances in the 
mixture in accordance with Article 10(2.3) of that Directive. 
If one generic safety data sheet is used to  cover several minor variants of a substance 
or mixture, the safety data sheet shall list  all names and variants or clearly describe 
the range of substances or mixtures covered. 
Other means of identification 
Other names or synonyms by which the su bstance or mixture is labelled or 
commonly known, such as alternative names, numbers, company product codes, or 
other unique identifiers shall be provided. 
1.2. Relevant identified uses of the substa nce or mixture and uses advised against 
At least the identified uses relevant for th e recipient(s) of the substance or mixture 
shall be indicated. This shall be a brief de scription of what the substance or mixture 
is intended to actually do, such as  “flame retardant”, “anti-oxidant”. 
The uses which the supplier advises agains t and why shall, where applicable, be 
stated. This need not be  an exhaustive list. 
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 scenario s from the chemical safety report set out in the annex 
to the safety data sheet. EN 9   EN 1.3. Details of the supplier of the substance or mixture 
The supplier, whether it is the manufact urer, importer, downstream user or 
distributor shall be identifi ed. The full address and tele phone number of the supplier 
shall be given as well as an  e-mail address for a competen t person responsible 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 addr ess and telephone number for th at responsible  person shall 
be given. 
For registrants, the information shall be consistent with the information on the 
identity of the manufacturer or im porter provided in the registration. 
1.4. Emergency telephone number 
References to emergency information serv ices shall be provide d. If an official 
advisory body exists (this may be the body  responsible for receiving information 
relating to health referred to in Arti cle 45 of Regulation (EC) No 1272/2008 and 
Article 17 of Directive 1999/45/EC), its te lephone number shall be given and can 
suffice. If any restrictions a pply, such as hours of operation,  or if there are limits on 
specific types of information provid ed, this shall be clearly stated. 
2. SECTION 2: Hazards identification 
This section of the safety data sheet shal l describe the hazards of the substance or 
mixture and the appropriate warning inform ation associated with those hazards. 
2.1. Classification of the substance or mixture  
In the case of a substance, the classificati on which arises from the application of the 
classification rules in Regulation (EC) No 1272/2008 shall be given. This 
classification shall be the same as the cla ssification provided to the classification and 
labelling inventory in accordance with Article 40 of Regulation (EC) No 1272/2008. 
The classification of the substance accord ing to Council Direc tive 67/548/EEC shall 
also be given. 
In the case of a mixture, the classificati on which arises from th e application of the 
classification rules in Dire ctive 1999/45/EC shall be gi ven. If the mixture does not 
meet the criteria for classification in accordance with Directive 1999/45/EC, this 
shall be clearly stated. Information on th e substances in the mixture is provided 
under Subsection 3.2. 
If the classification, including the hazard statements and R ph rases, is not written out 
in full, reference shall be made to Section 16 where the full text of each classification, including each hazard st atement and R phrase, shall be given. 
The most important adverse physicochem ical, human health and environmental 
effects shall be listed consistent with Sections 9 to 12 of the safety data sheet, in a EN 10   EN way as to allow even non-experts in the fiel d to identify the hazards for the substance 
or mixture. 
2.2. Label elements 
In the case of a substance, based on the classification, at least the following label 
elements appearing on the label in acco rdance with Regulation (EC) No 1272/2008 
shall be provided: hazard pictogram(s), signal word(s), hazard statement(s) and 
precautionary statement(s). The hazard pi ctogram may be provided as a graphical 
reproduction of the full hazard pictogram in black and white or as a graphical 
reproduction of the symbol only. 
In the case of a mixture, based on the classification, at least the appropriate 
symbol(s), indication(s) of danger, risk phr ase(s) and safety advice appearing on the 
label in accordance with Directive 1999/45/ EC shall be provided. The symbol may 
be provided as a graphical reproduction of th e symbol in black a nd white or using the 
name of the symbol as provided in Artic le 10(2.4) of Directive 1999/45/EC and 
Annex II to Council Di rective 67/548/EEC. 
The applicable label elements in accordan ce with Article 25 and Article 32(6) of 
Regulation (EC) No 1272/2008, in the case of a substance, or Annex V to Directive 
1999/45/EC, in the case of a mixture, shall be provided. 
2.3. Other hazards  
Information whether the substance or mixtur e meets the criteria fo r PBT or vPvB in 
accordance with Annex XIII shall be provided. 
Information shall be provided on other ha zards which do not resu lt 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, dust 
explosion hazards, cross-sensitisation, su ffocation, freezing, high potency for odour 
or taste, or environmental effects like hazards to soil-dwelling organisms, or 
photochemical ozone cr eation potential. 
3. SECTION 3: Composition/in formation on ingredients 
This section of the safety data sheet sh all describe the chemical identity of the 
ingredient(s) of the substance or mixt ure, including impurities and stabilising 
additives, which themselves meet the crite ria for classification and which contribute 
to the classification of th e substance or mixture. 
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 identification 
given in Subsection 1.1. 
The chemical identity of any impurity, stabi lising 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: EN 11   EN (a) the product identifier in accordance with  Article 18(2) of Regulation (EC) No 
1272/2008; 
(b) if the product identifier is not availa ble, one of the other names (usual name, 
trade name, abbreviation) or identification numbers. 
Suppliers of substances may choose to lis t in addition all constituents including non-
classified ones. 
This subsection may also be used to provide information on multi-constituent 
substances. 
3.2. Mixtures 
The product identifier when available, c oncentration or con centration ranges and 
classifications shall be provide d of at least all su bstances referred to in points 3.2.1 or 
3.2.2. Suppliers of mixtures may choose to lis t in addition all substances in the 
mixture, including substances not meeti ng the criteria for classification. This 
information shall enable the recipient to id entify readily the hazards  of the substances 
in the mixture. The hazards of the mixt ure itself shall be given in Section 2. 
The concentrations of the substances in a mi xture shall be describe d as either of the 
following: 
(a) exact percentages in descending or der by mass or volume, if technically 
possible; 
(b) ranges of percentages in descending order by mass or volum e, if technically 
possible. 
When using a range of percentages, 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 has been allowed under Article 15 of 
Directive 1999/45/EC or under Article 24 of Regulation (EC) No 1272/2008, that 
name can be used. 
3.2.1. For a mixture meeting the criteria for cl assification in accordance with Directive 
1999/45/EC, the following substances shall be indicated, together with their 
concentration or concentrat ion range in the mixture: 
(a) substances presenting a health or en vironmental hazard within the meaning of 
Council Directive 67/548/EEC and substances  presenting a health or environmental 
hazard within the meaning of Regulation (EC) No 1272/2008, provided that information complying with the classificati on criteria of that Regulation has been 
made available to the supplie r of the mixture, if those substances are present in 
concentrations equal to or greater than  the lowest of any of the following: EN 12   EN (i) the applicable concentrations defined in the table of Article 3 (3) of 
Directive 1999/45/EC; 
(ii) the specific concentration limits  given in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008; 
(iii) if an 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 calcula tion set out in section 4.1 of Annex 
I to that Regulation; 
(iv) the concentration limits given in  Part B of Annex II to Directive 
1999/45/EC; 
(v) the concentration limits given in Part B of Annex III Directive 
1999/45/EC; 
(vi) the concentration limits given in Annex V to Directive 1999/45/EC; 
(vii) the specific concentration limits  provided to the classification and 
labelling inventory established under Regulation (EC) No 1272/2008; 
(viii) if an M-factor has been provi ded to the classification and labelling 
inventory established under Regula tion (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 Comm unity workplace exposure limits, which 
are not already incl uded under point (a); 
(c) substances that are pers istent, bioaccumulative and t oxic or very persistent and 
very bioaccumulative in accordance with th e criteria set out in Annex XIII, or 
substances included in the list established in accordance with Article 59(1), for reasons other than the hazards referred to in  point (a), if the concentration of an 
individual substance is equal to or greater than 0,1 %. 
3.2.2. For a mixture not meeting the criteria for classification in acco rdance with Directive 
1999/45/EC, substances present in an indivi dual concentration e qual to or greater 
than the following concentrations shall be indicated, together with their concentration or concentration range: 
(a) 1% by weight in non-gaseous mixt ures and 0,2% by volume in gaseous 
mixtures for 
(i) substances which present a health or environmental h azard within the 
meaning of Council Direc tive 67/548/EEC and substances which present 
a health or environmental hazard wi thin the meaning of Regulation (EC) 
No 1272/2008, provided that information complying with the classification criteria of that Regula tion has been made available to the 
supplier of the mixture; or 
(ii) substances which are assigned Community workplace exposure limits; EN 13   EN (b) 0,1% by weight for substances which ar e persistent, bioaccumulative and toxic 
in accordance with the criteria set out in Annex XIII, very persistent and very bioaccumulative in accordance with the criteri a set out in Annex XIII, or included in 
the list established in accordance with Ar ticle 59(1) for reasons other than the 
hazards referred to in point (a). 
3.2.3. For the substances indicated  in Subsection 3.2, the clas sification of the substance 
according to Council Directive 67/548/EEC, including indication of danger, symbol letter(s) and R phrases, shall be provide d. 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 assigned in accordance with their physical, human 
health and environmental hazards, shall al so be provided, provided that information 
complying with the classification criteria of  that Regulation has been made available 
to the supplier of the mixture. The hazard statements and R phrases do not need to be written out in full in this section; their c odes shall be sufficient. In cases where they 
are not written out in full, re ference shall be made to Section 16, where the full text 
of each relevant hazard statement and R phr ase shall be listed. If the substance does 
not meet the classification criteria, th e reason for indicating the substance in 
Subsection 3.2 shall be described, such as  “non-classified vPvB substance" or 
"substance with a Community workplace exposure limit". 
3.2.4. For the substances indicated in Subsect ion 3.2 the name and, if available, the 
registration number, as assigned under Artic le 20(3) of this Regulation shall be 
given. The part of the regist ration number referring to th e 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 re gistration numbers of 
the substances contained in the mixture upon request to the recipi ent and any further 
recipients down the supply chain within 7 cale ndar days of the receipt of the request, 
or, if the full registration num bers are not available to hi m, a copy of th e request to 
his supplier(s) to provide the full registra tion numbers within 7 calendar days of the 
receipt of the request.  
(b) this supplier provides the full registrati on numbers of the substances contained in 
the mixture to the Member State author ities responsible for enforcement upon 
request within 7 calendar days. This dead line is prolonged by further 7 calendar days 
for each additional actor in the supply chain who needs to be consulted. In case an actor in the supply chain fails  to answer within this de adline, this supplier provides 
the relevant correspondence, including the na me and contact details of the actor in 
the supply chain who failed to answer th e correspondence, to the Member State 
authorities responsible for enforcement.  
The EC number, if available, shall be gi ven in accordance with Regulation (EC) No 
1272/2008. The CAS number, if available, and IUPAC name, if available, may also 
be given.  
4. SECTION 4: First aid measures 
This section of the safety data sheet shall describe the initial care in such a way that it 
can be understood and given by an un trained responder without the use of EN 14   EN sophisticated equipment and without the availability of a wide selection of 
medications. If medical attention is requi red, 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 effe cts can be expected 
after exposure; 
(b) movement of 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 symptoms and effects, both acute and delayed 
Briefly summarised information shall be provided on the most important symptoms 
and effects, both acute and delayed, from exposure. 
4.3. Indication of the immediate medical attention and special treatment needed 
Where appropriate, information shall be provided on clinical testing and medical 
monitoring for delayed effects, specific deta ils on antidotes (where they are known) 
and contraindications. 
For some substances or mixtures, it may be important to emphasise that special 
means to provide specific and immediate treatment shall be available at the workplace. 
5. SECTION 5: Fire-fighting 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 th e appropriate extinguishing media. 
Unsuitable extinguishing media: Indications shall be given whether any extinguishing medi a are inappropriate for a 
particular situation involving the substance or mixture. EN 15   EN 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 monoxi de if burning”; or 
“produces oxides of sulphur and nitrogen on combustion”. 
5.3. Special protective actions for fire-fighters 
Advice shall be provided on any protective ac tions to be taken during fire-fighting, 
such as “keep containers cool with water spray”. 
In addition, advice shall be provided on special protec tive equipment for fire-
fighters, such as boots, overalls, glove s, 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 betw een responses to large and 
small spills, in cases where the spill volume  has a significant imp act on the hazard. If 
the procedures for containment and recovery  indicate that diffe rent practices are 
required, these shall be indicated in the safety data sheet. 
6.1. Personal precautions, protective equipment and emergency procedures 
6.1.1. For non-emergency personnel 
Advice shall be provided related to accident al spills and release of the substance or 
mixture such as: 
(a) the wearing of suitable protective equipment (including personal protective 
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 ventila tion, control of dust; 
and 
(c) emergency procedures such as the n eed 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 environmenta l 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. EN 16   EN 6.3. Methods and material for containment and 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) neutralisatio n techniques; 
(b) decontamination techniques; (c) adsorbent materials; (d) cleaning techniques; (e) vacuuming techniques; (f) equipment required for containment/cle an 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 a nd 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 uses referred to under Subsection 1.2 and to the unique prope rties of the substance or mixture. 
Information in this section of the safety data sheet shall relate to the protection of 
human health, safety and the environment. It shall assist  the employer in devising 
suitable working procedures and organisati onal measures according to Article 5 of 
Directive 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 exposur e scenarios showing control of risk from 
the chemical safety report set out in the annex to the safety data sheet. 
In addition to information gi ven in this section, releva nt information may also be 
found in Section 8. EN 17   EN 7.1. Precautions for safe handling 
7.1.1. Recommendations shall be specified that: 
(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 incompatib le substances or mixtures; and 
(c) reduce the release of the substance or  mixture to the environment, such as 
avoiding spills or keep ing away from drains. 
7.1.2. Advice on general hygiene shall be provided, such as: 
(a) not to eat, drink and smoke in work areas; (b) to wash hands after use; and (c) to remove contaminated clothing a nd protective equipment before entering 
eating areas. 
7.2. Conditions for safe storage, in cluding any incompatibilities 
It shall be ensured that th e advice provided is 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 avoid: 
(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; (v) humidity; and (vi) vibration. EN 18   EN (c) How to maintain the integrity of the substance or mixture by the use of: 
(i) stabilisers; and (ii) anti-oxidants. 
(d) Other advice including: 
(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 identif ied use(s) referred to in Subs ection 1.2 and be detailed and 
operational. If an exposure scenario is atta ched, reference to it may be made or the 
information 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 scenar ios are consistent with the 
chemical safety report for the mixture instead of with the chemical safety reports for each substance in the mixture. If industry or  sector specific guidance is available, 
reference to it may be made. 
8. SECTION 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 exposur e scenarios showing control of risk from 
the chemical safety report set out in the annex to the safety data sheet. 
8.1. Control parameters 
Currently applicable specific control parame ters shall be specified, including national 
occupational exposure limit values that correspond to Community occupational exposure limit values or biological limit values in accordance with Directive 98/24/EC or Community limit values in accordance with Directive 2004/37/EC, and 
any other national occupational exposure limit values, as well as notations referred to 
in Article 2(1) of Co mmission Decision 95/320/EC
6 for the substance and for each of 
the substances in the mixture. Give  information on currently recommended 
monitoring procedures. 
                                                 
6 OJ L 188, 9.8.1995, p. 14. EN 19   EN 8.1.1. Where available, the national occupational exposure limit values that correspond to 
Community occupational exposure limit valu es or Community limit values, and any 
other national occupational exposure limit valu es, including notati ons, applicable for 
the Member State in which the safety data  sheet is being provided for the substance 
or for each of the substances in the mixture shall be listed. The legal basis of the occupational exposure limit shall be stated on the safety data sheet. When listing 
occupational exposure limit values, the chemical identity as specified in Section 3 shall be used. 
8.1.2. Where available, the national biological  limit values that correspond to Community 
biological limit values, and any other nati onal occupational biological limit values, 
including notations, applicable for the Member State in which the safety data sheet is being provided for the substance or for each of the substances in the mixture shall be listed. The legal basis of the biological limit value shall be stated on the safety data 
sheet. When listing biological limit values, the chemical identity as specified in 
Section 3 shall be used. 
8.1.3. If air contaminants are formed when us ing the substance or mixture as intended, 
applicable occupational exposure limit values and/or biological limit values for these 
shall also be listed. 
8.1.4. Where a chemical safety report is require d, the relevant DNELs as referred to in 
section 1.4 of Annex I and PNECs as referr ed to in Section 3.3 of Annex I 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 recommended for provi ding protection in 
relation to specific uses, sufficient detail  shall be given to enable effective 
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 the present subsection shall be provided, unless an 
exposure scenario containing that informati on 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 re lied on to justify the waiving. 
8.2.1. Appropriate engineering controls 
The description of appropriate exposure contro l measures shall relate to the identified 
use(s) of the substance or mixture as re ferred 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 
accordance with Articles 4 to 6 of Directive 98/24/EC as well as in accordance with 
Articles 3 to 5 of Directiv e 2004/37/EC, where appropriate. 
This information shall complement that already given under Section 7. 
8.2.2. Individual protection measures, su ch as personal protective equipment EN 20   EN 8.2.2.1. The use of personal protective equipment shall be consistent with good occupational 
hygiene practices and in conjunction w ith other control measures, including 
engineering controls, ventila tion and isolation. Where appr opriate, Section 5 shall be 
referred to for specific fire/chemical personal protective equipment advice. 
8.2.2.2. Taking into account Council Directive 89/686/EEC7 and referring to the appropriate 
CEN standards, detailed specifications sh all be given on which equipment will 
provide adequate and suita ble 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 poten tial for contact, such as safety glasses, 
safety goggles, face shield. 
(b) Skin protection 
(i) Hand protection 
The type of gloves to be worn when ha ndling the substance or mixture shall be 
clearly specified, including: 
– the type of material and its thickness, 
– the typical or minimum breakthroug h times of the glove material. 
If necessary any additional hand prot ection measures shall be indicated. 
(ii) Other 
If it is necessary to protect  a part of the body other th an the hands, the type and 
quality of protection equipment required sha ll 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 protecti on 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 proper purifyi ng element (cartridge or canister), the 
adequate particulate filters and the adequate masks, or  self contained breathing 
apparatus. 
(d) Thermal hazards 
                                                
 
7 OJ L 399, 30.12.1989, p. 18. EN 21   EN When specifying protective equipment to be  worn for materials that represent a 
thermal hazard, special consideration shal l be given to the construction of the 
personal protective equipment. 
8.2.3. Environmental exposure controls 
The information required by the empl oyer to fulfil his commitments under 
Community environmental protection legislation shall be specified. 
9. SECTION 9: Physical and chemical properties 
This section of the safety data sheet shall describe the empirical data of the substance 
or mixture, if relevant. The information in this section shall be consistent with the information provided in a registration and/ or in a chemical safety report where 
required, and with the classificati on of the substance or mixture. 
9.1. Information on basic physi cal and chemical properties 
The following properties shall be clearly identified including, where appropriate, a 
reference to the test methods used and specify appropriate units of measurement 
and/or reference conditions where appropriate . If relevant for the interpretation of the 
numerical value, the method of determinati on shall also be provided (for example the 
method for flash point, the ope n-cup/closed cup method): 
(a) Appearance:  The physical state (solid (including, if appropriate, information on granulometry), 
liquid, gas) and the colour of the substance or mixture as supplied shall be indicated; 
(b) Odour: If odour is perceptible, a brief de scription of it shall be given; 
(c) Odour threshold; (d) pH: The pH shall be indicated of the substance or mixture as supplied or of an aqueous 
solution; in the latter case, the concentration shall be indicated; 
(e) Melting point / freezing point; 
(f) Initial boiling poi nt and boiling range; 
(g) Flash point; (h) Evaporation rate; (i) Flammability (solid, gas); (j) Upper/lower flammability or explosive limits; (k) Vapour pressure; EN 22   EN (l) Vapour density; 
(m) Relative density; (n) Solubility(ies); (o) Partition coefficient: n-octanol/water; (p) Auto-ignition temperature; (q) Decomposition temperature; (r) Viscosity; (s) Explosive properties; (t) Oxidising properties. If it is stated that a partic ular property does not apply or if information on a particular 
property is not available, th e reasons shall be indicated. 
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 a registration where one is required. 
In the case of a mixture, the entries shall clearly indicate to which substance in the 
mixture the data apply, unless it is valid fo r the whole mixture. The data included in 
this subsection shall apply to  the substance or mixture. 
9.2. Other information 
Other physical and chemical parameters sh all be indicated as necessary, such as 
miscibility, fat solubility (solvent – oil to be specified), conductivity, or gas group. 
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 hazardous re actions occurring under certain conditions 
of use and also if released into the e nvironment, 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 prope rty is not available, the reasons shall be 
indicated. 
10.1. Reactivity 
10.1.1. The reactivity hazards of the substance or mixture shall be desc ribed. 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 ade quately represent the anticipated hazard of 
the substance or mixture. 
10.1.2. If data for mixtures are not available, da ta on substances in the mixture shall be 
provided. In determining incompatibil ity, the substances, containers and EN 23   EN 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 handlin g conditions of temper ature and pressure. 
Any stabilisers which are, or may need to be, used to maintain the product shall be described. The safety significance of any change in the physica l appearance of the 
product shall be indicated. 
10.3. Possibility of hazardous reactions 
If relevant, it shall be stated if the subs tance or mixture will react or polymerise, 
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, li ght, shock, static discha rge, vibrations or 
other physical stresses that mi ght result in a hazardous situ ation shall be listed and if 
appropriate a brief desc ription shall be given. 
10.5. Incompatible materials 
Families of substances or mixtures or specific substances, such as water, air, acids, 
bases, oxidising agents, with which the subs tance or mixture could react to produce a 
hazardous situation (like an e xplosion, a release of  toxic or flammable materials, or a 
liberation of excessive heat) shall be listed and if appropriate a br ief description shall 
be given. 
10.6. Hazardous decomposition products 
Known and reasonably anticipated hazardous decomposition products produced as a 
result of use, storage a nd heating shall be listed. H azardous combustion products 
shall be included in Section 5 of the safety data sheet. 
11. SECTION 11: Toxicological information 
This section of the safety data sheet is meant for use primarily by medical 
professionals, occupational he alth and safety professiona ls and toxicologists. A 
concise but complete and comprehensible description of the various toxicological 
(health) effects and the available data used to identify those effects shall be provided, 
including where appropriate informa tion on toxicokinetics, metabolism and 
distribution. The information in this secti on shall be consistent with the information 
provided in a registration and/or in a chem ical safety report where required, and with 
the classification of the substance or mixture. 
11.1. Information on t oxicological effects 
For substances, the relevant hazard classes or differentiations, for which information 
shall be provided, are: EN 24   EN (a) acute toxicity; 
(b) skin corrosion/irritation; (c) serious eye damage/irritation; (d) respiratory or skin sensitization; (e) germ cell mutagenicity; (f) carcinogenicity; (g) reproductive toxicity; (h) STOT-single exposure; (i) STOT-repeated exposure; (j) aspiration hazard. For mixtures, the relevant effects, for wh ich information shall be provided, are: 
(a) acute toxicity; (b) irritation; (c) corrosivity; (d) sensitisation; (e) repeated dose toxicity; (f) carcinogenicity; (g) mutagenicity; (h) toxicity for reproduction. For substances subject to registration, br ief summaries of the information derived 
from the application of Annexes VII to  XI shall be given, including, where 
appropriate, a reference to the test me thods used. For substances subject to 
registration, the information shall also in clude the result of the comparison of the 
available data with the criteria give n 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, differentiation or effect. If it is 
stated that the substance or mixture is not  classified for a particular hazard class, 
differentation or effect, the safety data shee t shall clearly state whether this is due to 
lack of data, technical impo ssibility 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 avai lable data, the classification criteria are 
not met.” EN 25   EN 11.1.2. The data included in this subsection shall a pply to the substance or mixture as placed 
on the market. If available, the relevant toxicological properties of the hazardous 
substances in a mixture shall also be pr ovided, such as the LD50, Acute 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 cr itical studies used, for example by route of 
exposure. 
11.1.4. Information shall be provided to support relevant negative data. 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 expos ure. If health effects are not known, this 
shall be stated. 
11.1.6. Symptoms related to the physical, chem ical and toxicological characteristics 
The potential adverse health effects and sy mptoms 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 related to the intended uses spec ified in Subsection 1.2. The first symptoms 
at the lowest exposures through to the cons equences of severe exposure shall be 
described, such as “headaches and dizzine ss 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 whether 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 subs tance or mixture shal l also be provided. 
Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicat ed whether toxicological data is based on 
human or animal data. 
11.1.8. Interactive effects 
Information on interactions shall be incl uded if relevant and readily available. 
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 specifi c substance or mixtur e are not available, 
data on similar substances or mixtures if  appropriate, may be used. Where specific 
data is not used, or where data are not available, this shal l be clearly stated. 
11.1.10. Mixtures EN 26   EN For a given health effect, if a mixture has not been tested for its health effects as a 
whole, relevant information on relevant s ubstances listed under Section 3 shall be 
provided and the mixture shall be classified  for that effect according to Directive 
1999/45/EC. 
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 different rates of absorption, metabolis m and excretion. As a result, the toxic 
actions may be altered and the overall toxic ity of the mixture may be different from 
that of the substances in it. 
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 presented 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 will occur at the concentrations present, such 
as when a mild irritant is diluted at a cer tain concentration in a non-irritant solution; 
(c) where information on interactions between substances in a mixture is not 
available, assumptions shall not be made and instead the health effects of each 
substance shall be listed separately. 
11.1.12. Other information 
Other relevant information on adverse health  effects shall be included even when not 
required by the classi fication criteria. 
12. SECTION 12: Ecological information 
This section of the safety data sheet sh all describe the information provided to 
evaluate the environmental imp act of the substance or mixture where it is released to 
the environment. Under Subsections 12.1 to  12.6 of the safety data sheet a short 
summary of the data shall be provided incl uding, where available, relevant test data 
and clearly indicating species , media, units, test duratio n and test conditions. This 
information may assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measur es and transport. If it is stated that a 
particular property does not a pply or if information on a pa rticular property is not 
available, the reasons shall be indicated. 
Information on bioaccumulation, persistence and degradability shall be given, where 
available and appropriate, for each relevant substance in the mixture. Information shall also be provided fo r hazardous transformation products arising from the 
degradation of substances and mixtures. 
The information in this section shall be c onsistent with the information provided in a 
registration and/or in a chemical safe ty report where required, and with the 
classification of the substance or mixture. EN 27   EN 12.1. Toxicity 
Information on toxicity using data from te sts performed on aquatic and/or terrestrial 
organisms shall be provided when availabl e. This shall include relevant available 
data on aquatic toxicity, both acute and chronic for fish, cr ustaceans, algae and other 
aquatic plants. In addition, toxicity data on soil micr o and macro-organisms and 
other environmentally relevant organisms, su ch as birds, bees and plants, shall be 
included when available. Where the substa nce or mixture has inhibitory effects on 
the activity of micro-organism s, the possible impact on sewage treatment plants shall 
be mentioned. 
For substances subject to re gistration, summaries of the information derived from the 
application of Annexes VII to XI shall be included. 
12.2. Persistence and degradability 
Persistence and degradability is the potenti al for the substance or the appropriate 
substances in a mixture to degrade in th e environment, either  through biodegradation 
or other processes such as ox idation or hydrolysis. Test results relevant to assess 
persistence and degradab ility shall be given where availa ble. If degrada tion half-lives 
are quoted it must be indicated whether thes e half lives refer to mineralisation or to 
primary degradation. The poten tial of the substance or certain substances in a 
mixture to degrade in sewage treatm ent plants shall also be mentioned. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. 
12.3. Bioaccumulative potential 
Bioaccumulative potential is the potential of the substance or certain substances in a 
mixture to accumulate in biota and, eventu ally, to pass through the food chain. Test 
results relevant to assess the bioaccumulative potential shall be given. This shall include reference to the octanol-wat er partition coefficient (Kow) and 
bioconcentration factor (BCF), if available. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. 
12.4. Mobility in soil 
Mobility in soil is the potential of the substance or the constituents 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 can  be determined from relevant mobility 
data such as adsorption studies or leachi ng studies, known or pred icted distribution to 
environmental compartments, or surface te nsion. For example, Koc values can be 
predicted from octanol/water partition coe fficients (Kow). Leaching and mobility can 
be predicted from models. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. EN 28   EN Where experimental data is available, that  data shall, in general, take precedence 
over models and predictions. 
12.5. Results of PBT and vPvB assessment 
Where a chemical safety report is requ ired, the results of the PBT and vPvB 
assessment as set out in the chemi cal safety report shall be given. 
12.6. Other adverse effects 
Information on any other adverse effects on the environment shall be included where 
available, such as environmental fate  (exposure), photoche mical ozone creation 
potential, ozone depletion pot ential, endocrine disruptin g potential and/or global 
warming potential.  
13. SECTION 13: Disposal considerations 
This section of the safety data sheet shall describe information for proper waste 
management of the substance or mixture and/or its container to assist in the 
determination of safe and environmenta lly preferred waste management options, 
consistent with the requirements in acco rdance with Directive 2008/98/EC of the 
European Parliament and of the Council8 of the Member State in which the safety 
data sheet is bei ng supplied. Information relevant  for the safety of persons 
conducting waste management activities sha ll complement the information given in 
Section 8. 
Where a chemical safety report is required, the information on the waste 
management measures 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. 
13.1. Waste treatment methods 
(a) Waste treatment containers and met hods shall be specified including the 
appropriate methods of waste treatment of  both the substance or mixture and any 
contaminated packaging (for example incineration, recycling, landfilling); 
(b) Physical/chemical properties that may affect waste treatment options shall be 
specified; 
(c) Sewage disposal shall be discouraged; 
(d) Where appropriate, any special precau tions for the chosen waste treatment 
option shall be identified. 
Any relevant Community provisions relating to waste shall be referred to. In their 
absence any relevant national or regional pr ovisions in force shall be referred to. 
                                                
 
8 OJ L 312, 22.11.2008, p. 3.  EN 29   EN 14. SECTION 14: Transport information 
This section of the safety data sheet shall provide basic classification information for 
transporting/shipment of substances or mi xtures mentioned under Section 1 by road, 
rail, sea, inland waterways or air. Where information is not available or relevant this shall be stated. 
Where relevant, it shall provide information on the transport classification for each of 
the UN Model Regulations: European Ag reement concerning the International 
Carriage of Dangerous Goods by Road (ADR)
9, Regulations concerning the 
International Carriage of Da ngerous Goods by Rail (RID)10, European Agreement 
concerning the Internationa l Carriage of Dangerous Goods by Inland  Waterways 
(ADN)11, all three of which have  been implemented by Di rective 2008/68/EC of the 
European Parliament and of the Council on the inland tran sport of dangerous 
goods12, International Maritime Da ngerous Goods (IMDG) Code13 (sea), and 
Technical Instructions fo r the Safe Transport of Dangerous Goods by Air (ICAO)14 
(air). 
14.1. UN number 
The UN number (i.e. the four-figure identifi cation number of the substance, mixture 
or article) from the UN Model Re gulations shall be provided. 
14.2. UN proper shipping name 
The UN proper shipping name from the UN Model Regulations shall be provided, 
unless it has appeared as the pr oduct identifier in Subsection 1.1. 
14.3. Transport hazard class(es) 
The transport hazard class (and subsidiary  risks) assigned to the substances or 
mixtures according to the predominant hazard  that they present in accordance with 
the UN Model Regulations shall be provided. 
14.4. Packing group 
The packing group number from the UN M odel Regulations shal l be provided, if 
applicable. The packing group number is  assigned to certain  substances in 
accordance with their degree of hazard. 
                                                 
9 United Nations, Economic Commission for Europe, version applicable as from 1 January 2009, ISBN-
978-92-1-139131-2. 
10 Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods by 
Rail) of the Convention concerning International Carr iage by Rail, version with effect from 1 January 
2009. 
11 Version as revised as of 1 January 2007. 
12 OJ L 260, 30.09.2008, p. 13. 
13 International Maritime Organisation, 2006 edition, ISBN 978-92-8001-4214-3. 
14 IATA, 2007-2008 edition. EN 30   EN 14.5. Environmental hazards 
It shall be indicated whether the substanc e or mixture is environmentally hazardous 
according to the criteria of the UN Model Regulations (as reflected in the IMDG Code, ADR, RID and ADN) and /or a marine pollutant according to the IMDG Code. If authorized for, or intende d to, carriage by inland waterw ays in tank-vessels, it shall 
be indicated whether the substance or mixt ure is environmentally  hazardous in tank-
vessels only according to ADN. 
14.6. Special precautions for user 
Information shall be provided on any speci al precautions, which a user must be 
aware of, or must comply with, in connect ion with transport or conveyance either 
within or outside his premises. 
14.7. Transport in bulk according to Annex II of MARPOL 73/78
 and the IBC Code  
This subsection only applies when cargoes are intended to be  carried in bulk 
according to the following International Ma ritime Organisation (IMO) instruments: 
Annex II of the Intern ational Convention for the Preven tion of Pollution from Ships, 
1973, as modified by the Protocol of  1978 relating thereto (MARPOL 73/78)15 and 
the International Code for the Constr uction and Equipment of Ships carrying 
Dangerous Chemicals in Bulk (Internat ional Bulk Chemical Code) (IBC Code)16. 
The product name shall be provided (if name is different to 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 Marine Environment Protection Committee (MEPC).2/Circular
17. Ship type required and pollu tion category shall be indicated. 
15. SECTION 15: Regulatory information 
This section of the safety data sheet sha ll describe the other regulatory information 
on the substance or mixture that is not alre ady provided in the safety data sheet (such 
as whether the substance or mixture is subject to Regulation (EC) No 2037/2000 of 
the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer
18, Regulation (EC) No 850/2004 of  the European Parliament 
and of the Council of 29 April 2004 on pers istent organic pollutants and amending 
Directive 79/117/EEC19 or Regulation (EC) No 689/2008 of the European Parliament 
and of the Council of 17 June 2008 concer ning the export and import of dangerous 
chemicals20). 
                                                 
15 MARPOL 73/78 – Consolidated edition 2006, London, IMO 2007, ISBN 978-92-801-4216-7. 
16 IBC Code, 2007 edition, London, IMO 2007, ISBN 978-92-801-4226-6. 
17 MEPC.2/Circular, Provisional categ orization of liquid substances, version 14, effective 1 January 2009. 
18 OJ L 244, 29.9.2000, p. 1. 
19 OJ L 229, 30.4.2004, p. 5. 
20 OJ L 204, 31.7.2008, p. 1. EN 31   EN 15.1. Safety, health and environmental reg ulations/legislation specific for the 
substance or mixture 
Relevant Community safety, health and e nvironmental provisions (for example the 
SEVESO-category) or national information on the regulatory status of the substance 
or mixture (including the substances in the mixture) shall be provided. Where 
relevant the national laws of the relevant Member States which implement these provisions and any other national measures th at may be relevant shall be mentioned. 
If the substance or mixture covered by this sa fety data sheet is the subject of specific 
provisions in relation to protection of human health or the environment at 
Community level (such as aut horisations given under Titl e VII or restrictions under 
Title VIII) these provisions shall be mentioned and any authorisation number shall be 
provided. 
15.2. Chemical Safety Assessment 
It shall be indicated if a chemical safety  assessment has been carried out for the 
substance or the mixture by the supplier. 
16. SECTION 16: Other information 
This section of the safety data sheet shal l describe the informa tion relevant to the 
compilation of the safety data sheet. It shall incorporate other information that does not belong in Sections 1 to 15, including in formation on revision of the safety data 
sheet such as: 
(a) in case of a revised safety data sheet,  a clear indication of where changes have 
been made to the previous version of the sa fety 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 s ubstance or mixture shall main tain an explanation of the 
changes and provide it upon request; 
(b) a key or legend to abbreviations and acronyms used in the safety data sheet; 
(c) key literature references and sources for data; 
(d) list of relevant R phrases, hazard statem ents, safety advice and/or precautionary 
statements. Write out the full text of any st atements which are not written out in full 
under Sections 2 and 3; 
(e) training advice. If a supplier of a substance or mixture chooses to identify the classification in 
accordance with Article 31(10) in advance of applying it fully, the supplier of a 
substance or mixture may include th is classification in this section. 
PART B The safety data sheet shall include th e following 16 headings in accordance with 
Article 31(6) and in addition the subheadings also listed: EN 32   EN 1. SECTION 1: Identification of the substance/mixture and of the 
company/undertaking 
1.1. Product identifier 1.2. Relevant identified uses of the substa nce or mixture and uses advised against 
1.3. Details of the supplier of the substance or mixture 1.4. Emergency telephone number 2. SECTION 2: Hazards identification 2.1. Classification of the substance or mixture 2.2. Label elements 2.3. Other hazards 3. SECTION 3: Composition/information on ingredients 3.1. Substances 3.2. Mixtures 4. SECTION 4: First aid measures 4.1. Description of first aid measures 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of immediate medical atte ntion and special treatment needed 
5. SECTION 5: Fire-fighting measures 5.1. Extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Special protective actio ns for fire-fighters 
6. 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 7. SECTION 7: Handling and storage 
7.1. Precautions for safe handling 
7.2. Conditions for safe storage, including any incompatibilities EN 33   EN 7.3. Specific end use(s) 
8. SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls 9. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties 9.2. Other information 10. 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 11. SECTION 11: Toxicological information 11.1. Information on toxicological effects 12. 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. Other adverse effects 13. SECTION 13: Disposal considerations 13.1. Waste treatment methods 14. SECTION 14: Transport information 
14.1. UN number EN 34   EN 14.2. UN proper shipping name 
14.3. Transport hazard class(es) 14.4. Packing group 14.5. Environmental hazards 14.6. Special precautions for user 14.7. Transport in bulk according to Anne x II of MARPOL73/78 and the IBC Code 
15. SECTION 15: Regulatory information 15.1. Safety, health and environmental re gulations/legislation specific for the 
substance or mixture 
15.2. Chemical Safety Assessment 
16. SECTION 16: Other information ' EN 35   EN ANNEX II  
'ANNEX II  
REQUIREMENTS FOR THE COMPILAT ION 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 mixtur e in accordance with 
Article 31. 
0.1.2. The information provided in the safety data sheet shall be consistent with the 
information in the chemical safety report,  where one is 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. 
0.2. General requirements for comp iling 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, handl ing and disposal of the substance or the 
mixture. 
0.2.2. The information provided by safety data sh eets shall also meet the requirements set 
out in Council Directive 98/24/ EC. In particular, the safety data sheet shall enable 
employers to determine whether any hazardou s chemical agents are present in the 
workplace, and to assess any risk to the he alth 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 competent person who shall take into account the specific needs and know ledge of the user audience, as far as 
they are known. Suppliers of  substances and mixtures shall ensure that such 
competent persons have received appropr iate training, includi ng refresher training. 
0.2.4. The language used in the sa fety data sheet shall be simple, clear and precise, 
avoiding jargon, acronyms a nd 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 subs tance 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 da ta sheet shall be given on the first page. 
When a safety data sheet has been revised and the new, revised ve rsion is provided to 
recipients, the changes shall be brought to th e attention of the recipient in Section 16 
of the safety data sheet, unl ess they have been indicated elsewhere. In that case, the 
date of compilation identified as “Revision: (date)” as well as a version number, EN 36   EN revision number, supersedes date or other i ndication of what version is replaced shall 
appear on the first page. 
0.3. Safety data sheet format 
0.3.1. A safety data sheet is not a fixed length doc ument. 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 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 “Continue d on next page” or “End of safety data 
sheet”). 
0.4. Safety data sheet content 
The information required by this  Annex shall be included in the safety data sheet, 
where applicable and available, under the re levant subsections set out in Part B. The 
safety data sheet shall no t contain blank subsections. 
0.5. Other information requirements 
The inclusion of additional relevant and available information under the relevant 
subsections may be necessary in some cases in view of the wide  range of properties 
of substances and mixtures. 
0.6. Units 
The units of measurement as set out in Council Directive 80/181/EEC21 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 prescribes 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 substa nce or mixture including an 
emergency contact shall be provide d in the safety data sheet. 
1.1. Product identifier 
The product identifier shall be provided in accordance with Article 18(2) of 
Regulation (EC) No 1272/2008 and as prov ided on the label in the official 
                                                 
21 OJ L 39, 15.2.1980, p. 40. EN 37   EN 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) otherwise. 
For substances subject to registration, the pr oduct 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 indi cated. 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) that supplier assumes the responsibil ity to provide the fu ll registration number 
upon request to the recipient and any furthe r recipients down the supply chain within 
7 calendar days of the receipt of the request , or, if the full registration number is not 
available to him, a copy of the request to his supplier to provide the full registration 
number within 7 calendar days of the receipt of the request; and  
(b) that supplier provides the full registra tion number to the Member State authorities 
responsible for enforcement upon request w ithin 7 calendar days . This deadline is 
prolonged by further 7 calendar days for each additional actor in the supply chain 
who needs to be consulted. In case an actor in the supply chain fails  to answer within 
this deadline, this supplie r provides the relevant corre spondence, including the name 
and contact details of the actor in the supply chain who failed to answer the 
correspondence, to the Member State auth orities responsible for enforcement. 
If one generic safety data sheet is used to  cover several minor variants of a substance 
or mixture, the safety data sheet shall list  all names and variants or clearly describe 
the range of substances or mixtures covered. 
Other means of identification 
Other names or synonyms by which the su bstance or mixture is labelled or 
commonly known, such as alternative names, numbers, company product codes, or 
other unique identifiers shall be provided. 
1.2. Relevant identified uses of the substa nce or mixture and uses advised against 
At least the identified uses relevant for th e recipient(s) of the substance or mixture 
shall be indicated. This shall be a brief de scription of what the substance or mixture 
is intended to actually do, such as  “flame retardant”, “anti-oxidant”. 
The uses which the supplier advises agains t and why shall, where applicable, be 
stated. This need not be  an exhaustive list. 
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 scenario s from the chemical safety report set out in the annex 
to the safety data sheet. 
1.3. Details of the supplier of the substance or mixture 
The supplier, whether it is the manufact urer, importer, downstream user or 
distributor shall be identifi ed. The full address and tele phone number of the supplier EN 38   EN shall be given as well as an  e-mail address for a competen t person responsible 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 addr ess and telephone number for th at responsible  person shall 
be given. 
For registrants, the information shall be consistent with the information on the 
identity of the manufacturer or im porter provided in the registration. 
1.4. Emergency telephone number 
References to emergency information serv ices shall be provide d. If an official 
advisory body exists (this may be the body  responsible for receiving information 
relating to health referred to in Article 45 of Regul ation (EC) No 1272/2008, its 
telephone number shall be given and can suffi ce. If any restrictions apply, such as 
hours of operation, or if ther e are limits on specific ty pes of information provided, 
this shall be clearly stated. 
2. SECTION 2: Hazards identification 
This section of the safety data sheet shal l describe the hazards of the substance or 
mixture and the appropriate warning inform ation associated with those hazards. 
2.1. Classification of the substance or mixture  
The classification of the subs tance or the mixture which ar ises from the application 
of the classification rules in Regula tion (EC) No 1272/2008 shall be given. The 
classification given for a substance shall be the same as the classification provided to 
the classification and labelling inventory in  accordance with Article 40 of Regulation 
(EC) No 1272/2008. 
If the mixture does not meet the criteria  for classification in accordance with 
Regulation (EC) No 1272/2008, this  shall be clearly stated. 
Information on the substances in the mixture is provided under Subsection 3.2. 
If the classification, including the hazard statements and R ph rases, is not written out 
in full, reference shall be made to Section 16 where the full text of each classification, including each hazard st atement and R phrase, shall be given. 
The most important adverse physicochem ical, human health and environmental 
effects shall be listed consistent with Sections 9 to 12 of the safety data sheet, in a way as to allow even non-experts in the fiel d to identify the hazards for the substance 
or mixture. 
2.2. Label elements 
Based on the classification, at least the fo llowing label elements appearing on the 
label in accordance with Regulation (EC)  No 1272/2008 shall be provided: hazard 
pictogram(s), signal word(s), hazard stat ement(s) and precautionary statement(s). EN 39   EN The hazard pictogram may be provided as a graphical reproduction of the full hazard 
pictogram in black and white or as a gr aphical reproduction of the symbol only. 
The applicable label elements in accordan ce with Article 25 and Article 32(6) of 
Regulation (EC) No 1272/ 2008 shall be provided. 
2.3. Other hazards  
Information whether the substance or mixtur e meets the criteria fo r PBT or vPvB in 
accordance with Annex XIII shall be provided. 
Information shall be provided on other ha zards which do not resu lt 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, dust 
explosion hazards, cross-sensitisation, su ffocation, freezing, high potency for odour 
or taste, or environmental effects like hazards to soil-dwelling organisms, or 
photochemical ozone cr eation potential. 
3. SECTION 3: Composition/in formation on ingredients 
This section of the safety data sheet sh all describe the chemical identity of the 
ingredient(s) of the substance or mixt ure, including impurities and stabilising 
additives, which themselves meet the crite ria for classification and which contribute 
to the classification of th e substance or mixture. 
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 identification 
given in Subsection 1.1. 
The chemical identity of any impurity, stabi lising 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: 
(a) the product identifier in accordance with  Article 18(2) of Regulation (EC) No 
1272/2008; 
(b) if the product identifier is not availa ble, one of the other names (usual name, 
trade name, abbreviation) or identification numbers. 
Suppliers of substances may choose to lis t in addition all constituents including non-
classified ones. 
This subsection may also be used to provide information on multi-constituent 
substances. 
3.2. Mixtures 
The product identifier, concentration or con centration ranges and classifications shall 
be provided of at least all substances referred to in poi nts 3.2.1 or 3.2.2. Suppliers of 
mixtures may choose to list in addition all substances in the mixture, including EN 40   EN substances not meeting the criteria for cl assification. 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 mi xture shall be describe d as either of the 
following: 
(a) exact percentages in descending or der by mass or volume, if technically 
possible; 
(b) ranges of percentages in descending order by mass or volum e, if technically 
possible. 
When using a range of percentages, 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 has been allowed under Article 15 of 
Directive 1999/45/EC or under Article 24 of Regulation (EC) No 1272/2008, that 
name can be used.  
3.2.1. For a mixture meeting the criteria for cl assification in accord ance with Regulation 
(EC) No 1272/2008, the following substances sh all be indicated, together with their 
concentration or concentrat ion range in the mixture: 
(a) substances presenting a health or en vironmental hazard within the meaning of 
Regulation (EC) No 1272/2008, if those subs tances are present in concentrations 
equal to or greater than the lowest of any of the following: 
(ia) the generic cut-off values set out  in Table 1.1 of Regulation (EC) No 
1272/2008; 
(ib) the generic concentration limits given in parts 3 to 5 of Annex I to 
Regulation (EC) No 1272/2008; 
List of substance hazards and concentrati on limits for which a substance shall be 
listed as a substance in a mixture in Section 3. 
1.1. Hazard class and category 
Concentration limit % 
Acute toxicity, category 1,2 and 3 > 0,1  
Acute toxicity, category 4 > 1  
Skin corrosion/irritation, category 1A, 1B, 1C and 2 > 1  
Serious damage to eyes/eye irritation, category 1 and 2 > 1  
Respiratory/skin sensitisation > 0,1  
Germ cell mutagenicity category 1A and 1B > 0,1 EN 41   EN 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 and 2  > 1  
Specific target organ toxicity (STOT) – repeated exposure, 
category 1 and 2 > 1  
Aspiration hazard > 1 
Hazardous to the aquatic environm ent – Acute, category 1  > 0,1  
Hazardous to the aquatic envi ronment – Chronic, category 
1  > 0,1 
Hazardous to the aquatic envi ronment – Chronic, category 
2, 3 and 4 > 1 
Hazardous for the ozone layer > 0,1  
(ii) the specific concentration limits  given in Part 3 of Annex VI to 
Regulation (EC) No 1272/2008; 
(iii) if an 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 calcula tion set out in section 4.1 of Annex 
I to that Regulation; 
(vii) the specific concentration limits  provided to the classification and 
labelling inventory established under Regulation (EC) No 1272/2008; 
(viia) the concentration limits set ou t in Annex II of Regulation (EC) No 
1272/2008; 
(viii) if an M-factor has been provi ded to the classification and labelling 
inventory established under Regula tion (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 Comm unity workplace exposure limits, which 
are not already incl uded under point (a); 
(c) substances that are pers istent, bioaccumulative and t oxic or very persistent and 
very bioaccumulative in accordance with th e criteria set out in Annex XIII, or 
substances included in the list established in accordance with Article 59(1), for reasons other than the hazards referred to in  point (a), if the concentration of an 
individual substance is equal to or greater than 0,1 %. EN 42   EN 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  concentration range: 
(a) 1% by weight in non-gaseous mixt ures and 0,2% by volume in gaseous 
mixtures for 
(i) substances which present a health or environmental h azard within the 
meaning of Regulation (EC) No 1272/2008; or 
(ii) substances which are assigned Community workplace exposure limits; 
(b) 0,1% by weight for substances which ar e persistent, bioaccumulative and toxic 
in accordance with the criteria set out in Annex XIII, very persistent and very bioaccumulative in accordance with the criteri a set out in Annex XIII, or included in 
the list established in accordance with Ar ticle 59(1) for reasons other than the 
hazards referred to in point (a). 
3.2.3. For the substances indicated  in Subsection 3.2, the clas sification 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 assigned in accordance with their physical, human 
health and environmental hazards, shall be provided, provided that information 
complying with the classification criteria of  that Regulation has been made available 
to the supplier of the mixture. The hazard statements and R phrases do not need to be written out in full in this section; their c odes shall be sufficient. In cases where they 
are not written out in full, re ference shall be made to Section 16, where the full text 
of each relevant hazard statement and R phr ase shall be listed. If the substance does 
not meet the classification criteria, th e reason for indicating the substance in 
Subsection 3.2 shall be described, such as  “non-classified vPvB substance" or 
"substance with a Community workplace exposure limit". 
3.2.4. For the substances indicated in Subsect ion 3.2 the name and, if available, the 
registration number, as assigned under Artic le 20(3) of this Regulation shall be 
given. The part of the regist ration number referring to th e 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 re gistration numbers of 
the substances contained in the mixture upon request to the recipi ent and any further 
recipients down the supply chain within 7 cale ndar days of the receipt of the request, 
or, if the full registration num bers are not available to hi m, a copy of th e request to 
his supplier(s) to provide the full registra tion numbers within 7 calendar days of the 
receipt of the request.  
(b) this supplier provides the full registrati on numbers of the substances contained in 
the mixture to the Member State author ities responsible for enforcement upon 
request within 7 calendar days. This dead line is prolonged by further 7 calendar days 
for each additional actor in the supply chain who needs to be consulted. In case an actor in the supply chain fails  to answer within this de adline, this supplier provides 
the relevant correspondence, including the na me and contact details of the actor in EN 43   EN the supply chain who failed to answer th e correspondence, to the Member State 
authorities responsible for enforcement.  
The EC number, if available, shall be gi ven in accordance with Regulation (EC) No 
1272/2008. The CAS number, if available, and IUPAC name, if available, may also 
be given.  
4. SECTION 4: First aid measures 
This section of the safety data sheet shall describe the initial care in such a way that it 
can be understood and given by an un trained responder without the use of 
sophisticated equipment and without the availability of a wide selection of 
medications. If medical attention is requi red, 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 effe cts can be expected 
after exposure; 
(b) movement of 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 symptoms and effects, both acute and delayed 
Briefly summarised information shall be provided on the most important symptoms 
and effects, both acute and delayed, from exposure. 
4.3. Indication of the immediate medical attention and special treatment needed 
Where appropriate, information shall be provided on clinical testing and medical 
monitoring for delayed effects, specific deta ils on antidotes (where they are known) 
and contraindications. 
For some substances or mixtures, it may be important to emphasise that special 
means to provide specific and immediate treatment shall be available at the workplace. 
5. SECTION 5: Fire-fighting 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. EN 44   EN 5.1. Extinguishing media 
Suitable extinguishing media: 
Information shall be provided on th e appropriate extinguishing media. 
Unsuitable extinguishing media: Indications shall be given whether any extinguishing medi a are inappropriate for a 
particular situation involving the substance or 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 monoxi de if burning”; or 
“produces oxides of sulphur and nitrogen on combustion”. 
5.3. Special protective actions for fire-fighters 
Advice shall be provided on any protective ac tions to be taken during fire-fighting, 
such as “keep containers cool with water spray”. 
In addition, advice shall be provided on special protec tive equipment for fire-
fighters, such as boots, overalls, glove s, 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 betw een responses to large and 
small spills, in cases where the spill volu me has a significant impact on the hazard. If 
the procedures for containment and recovery  indicate that diffe rent practices are 
required, these shall be indicated in the safety data sheet. 
6.1. Personal precautions, protective equipment and emergency procedures 
6.1.1. For non-emergency personnel 
Advice shall be provided related to accident al spills and release of the substance or 
mixture such as: 
(a) the wearing of suitable protective equipment (including personal protective 
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 ventila tion, control of dust; 
and 
(c) emergency procedures such as the n eed to evacuate the danger area or to 
consult an expert. EN 45   EN 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 environmenta l 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 and 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) neutralisatio n techniques; 
(b) decontamination techniques; (c) adsorbent materials; (d) cleaning techniques; (e) vacuuming techniques; (f) equipment required for containment/cle an 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 a nd 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 uses referred to under Subsection 1.2 and to the unique prope rties of the substance or mixture. 
Information in this section of the safety data sheet shall relate to the protection of 
human health, safety and the environment. It shall assist  the employer in devising EN 46   EN suitable working procedures and organisati onal measures according to Article 5 of 
Directive 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 exposur e scenarios showing control of risk from 
the chemical safety report set out in the annex to the safety data sheet. 
In addition to information gi ven in this section, releva nt information may also be 
found in Section 8. 
7.1. Precautions for safe handling 
7.1.1. Recommendations shall be specified that: 
(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 incompatib le substances or mixtures; and 
(c) reduce the release of the substance or  mixture to the environment, such as 
avoiding spills or keep ing away from drains. 
7.1.2. Advice on general hygiene shall be provided, such as: 
(a) not to eat, drink and smoke in work areas; (b) to wash hands after use; and (c) to remove contaminated clothing a nd protective equipment before entering 
eating areas. 
7.2. Conditions for safe storage, in cluding any incompatibilities 
It shall be ensured that th e advice provided is 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 avoid: 
(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: EN 47   EN (i) weather conditions; 
(ii) ambient pressure; (iii) temperature; (iv) sunlight; (v) humidity; and (vi) vibration. 
(c) How to maintain the integrity of the substance or mixture by the use of: 
(i) stabilisers; and (ii) anti-oxidants. 
(d) Other advice including: 
(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 identif ied use(s) referred to in Subs ection 1.2 and be detailed and 
operational. If an exposure scenario is atta ched, reference to it may be made or the 
information 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 scenar ios are consistent with the 
chemical safety report for the mixture instead of with the chemical safety reports for each substance in the mixture. If industry or  sector specific guidance is available, 
reference to it may be made. 
8. SECTION 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 exposur e scenarios showing control of risk from 
the chemical safety report set out in the annex to the safety data sheet. EN 48   EN 8.1. Control parameters 
Currently applicable specific control parame ters shall be specified, including national 
occupational exposure limit values that correspond to Community occupational exposure limit values or biological limit values in accordance with Directive 98/24/EC or Community limit values in accordance with Directive 2004/37/EC, and 
any other national occupational exposure limit values, as well as notations referred to 
in Article 2(1) of Co mmission Decision 95/320/EC
22 for the substance and for each 
of the substances in th e mixture. Give informa tion on currently recommended 
monitoring procedures. 
8.1.1. Where available, the national occupational exposure limit values that correspond to 
Community occupational exposure limit valu es or Community limit values, and any 
other national occupational exposure limit valu es, including notati ons, applicable for 
the Member State in which the safety data  sheet is being provided for the substance 
or for each of the substances in the mixture shall be listed. The legal basis of the occupational exposure limit shall be stated on the safety data sheet. When listing 
occupational exposure limit values, the chemical identity as specified in Section 3 shall be used. 
8.1.2. Where available, the national biological  limit values that correspond to Community 
biological limit values, and any other nati onal occupational biological limit values, 
including notations, applicable for the Member State in which the safety data sheet is being provided for the substance or for each of the substances in the mixture shall be listed. The legal basis of the biological limit value shall be stated on the safety data 
sheet. When listing biological limit values, the chemical identity as specified in 
Section 3 shall be used. 
8.1.3. If air contaminants are formed when us ing the substance or mixture as intended, 
applicable occupational exposure limit values and/or biological limit values for these 
shall also be listed. 
8.1.4. Where a chemical safety report is require d, the relevant DNELs as referred to in 
section 1.4 of Annex I and PNECs as referr ed to in Section 3.3 of Annex I 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 recommended for provi ding protection in 
relation to specific uses, sufficient detail  shall be given to enable effective 
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 the present subsection shall be provided, unless an 
exposure scenario containing that informati on is attached to the safety data sheet. 
Where the supplier has waived a test under se ction 3 of Annex XI, he shall indicate 
the specific conditions of use re lied on to justify the waiving. 
                                                
 
22 OJ L 188, 9.8.1995, p. 14. EN 49   EN 8.2.1. Appropriate engineering controls 
The description of appropriate exposure contro l measures shall relate to the identified 
use(s) of the substance or mixture as re ferred 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 
accordance with Articles 4 to 6 of Directive 98/24/EC as well as in accordance with 
Articles 3 to 5 of Directiv e 2004/37/EC, where appropriate. 
This information shall complement that already given under Section 7. 
8.2.2. Individual protection measures, su ch as personal protective equipment 
8.2.2.1. The use of personal protective equipment shall be consistent with good occupational 
hygiene practices and in conjunction w ith other control measures, including 
engineering controls, ventila tion and isolation. Where appr opriate, Section 5 shall be 
referred to for specific fire/chemical personal protective equipment advice. 
8.2.2.2. Taking into account Council Directive 89/686/EEC23 and referring to the appropriate 
CEN standards, detailed specifications sh all be given on which equipment will 
provide adequate and suita ble 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 poten tial for contact, such as safety glasses, 
safety goggles, face shield. 
(b) Skin protection 
(i) Hand protection 
The type of gloves to be worn when ha ndling the substance or mixture shall be 
clearly specified, including: 
– the type of material and its thickness, 
– the typical or minimum breakthroug h times of the glove material. 
If necessary any additional hand prot ection measures shall be indicated. 
(ii) Other 
If it is necessary to protect  a part of the body other th an the hands, the type and 
quality of protection equipment required sha ll 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 protecti on measures and specific hygiene measures 
shall be indicated. 
                                                
 
23 OJ L 399, 30.12.1989, p. 18. EN 50   EN (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 proper purifyi ng 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 shal l be given to the construction of the 
personal protective equipment. 
8.2.3. Environmental exposure controls 
The information required by the empl oyer to fulfil his commitments under 
Community environmental protection legislation shall be specified. 
9. SECTION 9: Physical and chemical properties 
This section of the safety data sheet shall describe the empirical data of the substance 
or mixture, if relevant. Article 8(2) of Regulation (EC) No 1272/2008 shall apply. 
The information in this section shall be c onsistent with the information provided in a 
registration and/or in a chemical safe ty report where required, and with the 
classification of the substance or mixture. 
9.1. Information on basic physi cal and chemical properties 
The following properties shall be clearly identified including, where appropriate, a 
reference to the test methods used and specify appropriate units of measurement 
and/or reference conditions where appropriate . If relevant for the interpretation of the 
numerical value, the method of determinati on shall also be provided (for example the 
method for flash point, the ope n-cup/closed cup method): 
(a) Appearance:  
The physical state (solid (including, if appropriate, information on granulometry), 
liquid, gas) and the colour of the substance or mixture as supplied shall be indicated; 
(b) Odour: If odour is perceptible, a brief de scription of it shall be given; 
(c) Odour threshold; (d) pH: The pH shall be indicated of the substance or mixture as supplied or of an aqueous 
solution; in the latter case, the concentration shall be indicated; 
(e) Melting point / freezing point; EN 51   EN (f) Initial boiling poi nt and boiling range; 
(g) Flash point; (h) Evaporation rate; (i) Flammability (solid, gas); (j) Upper/lower flammability or explosive limits; (k) Vapour pressure; (l) Vapour density; (m) Relative density; (n) Solubility(ies); (o) Partition coefficient: n-octanol/water; (p) Auto-ignition temperature; (q) Decomposition temperature; (r) Viscosity; (s) Explosive properties; (t) Oxidising properties. If it is stated that a partic ular property does not apply or if information on a particular 
property is not available, th e reasons shall be indicated. 
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 a registration where one is required. 
In the case of a mixture, the entries shall clearly indicate to which substance in the 
mixture the data apply, unless it is valid fo r the whole mixture. The data included in 
this subsection shall apply to  the substance or mixture. 
9.2. Other information 
Other physical and chemical parameters sh all be indicated as necessary, such as 
miscibility, fat solubility (solvent – oil to be specified), conductivity, or gas group. 
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 hazardous re actions occurring under certain conditions 
of use and also if released into the e nvironment, including, where appropriate, a 
reference to the test methods used. If it is  stated that a particular property does not EN 52   EN apply or if information on a particular prope rty is not available, the reasons shall be 
indicated. 
10.1. Reactivity 
10.1.1. The reactivity hazards of the substance or mixture shall be descri bed. 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 ade quately represent the anticipated hazard of 
the substance or mixture. 
10.1.2. If data for mixtures are not available, da ta on substances in the mixture shall be 
provided. In determining incompatibil ity, 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 handlin g conditions of temper ature and pressure. 
Any stabilisers which are, or may need to be, used to maintain the product shall be described. The safety significance of any change in the physica l appearance of the 
product shall be indicated. 
10.3. Possibility of hazardous reactions 
If relevant, it shall be stated if the subs tance or mixture will react or polymerise, 
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, li ght, shock, static discha rge, vibrations or 
other physical stresses that mi ght result in a hazardous situ ation shall be listed and if 
appropriate a brief desc ription shall be given. 
10.5. Incompatible materials 
Families of substances or mixtures or specific substances, such as water, air, acids, 
bases, oxidising agents, with which the subs tance or mixture could react to produce a 
hazardous situation (like an e xplosion, a release of  toxic or flammable materials, or a 
liberation of excessive heat) shall be listed and if appropriate a br ief description shall 
be given. 
10.6. Hazardous decomposition products 
Known and reasonably anticipated hazardous decomposition products produced as a 
result of use, storage a nd heating shall be listed. H azardous combustion products 
shall be included in Section 5 of the safety data sheet. EN 53   EN 11. SECTION 11: Toxicological information 
This section of the safety data sheet is meant for use primarily by medical 
professionals, occupational he alth and safety professiona ls and toxicologists. A 
concise but complete and comprehensible description of the various toxicological 
(health) effects and the available data used to identify those effects shall be provided, 
including where appropriate informa tion on toxicokinetics, metabolism and 
distribution. The information in this secti on shall be consistent with the information 
provided in a registration and/or in a chem ical safety report where required, and with 
the classification of the substance or mixture. 
11.1. Information on t oxicological effects 
The relevant hazard classes or differen tiations, for which information shall be 
provided, are: 
(a) acute toxicity; (b) skin corrosion/irritation; (c) serious eye damage/irritation; (d) respiratory or skin sensitization; (e) germ cell mutagenicity; (f) carcinogenicity; (g) reproductive toxicity; (h) STOT-single exposure; (i) STOT-repeated exposure; (j) aspiration hazard. For substances subject to registration, br ief summaries of the information derived 
from the application of Annexes VII to  XI shall be given, including, where 
appropriate, a reference to the test me thods used. For substances subject to 
registration, the information shall also in clude the result of the comparison of the 
available data with the criteria give n 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, differentiation or effect. If it is 
stated that the substance or mixture is not  classified for a particular hazard class, 
differentation or effect, the safety data shee t shall clearly state whether this is due to 
lack of data, technical impo ssibility 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 avai lable data, the classification criteria are 
not met.” 
11.1.2. The data included in this subsection shall a pply to the substance or mixture as placed 
on the market. In the case of a mixture, the data should describe the toxicological EN 54   EN properties of the mixture as a whole, excep t 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 pr ovided, such as the LD50, Acute 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 cr itical studies used, for example by route of 
exposure. 
11.1.4. Information shall be provided to support relevant negative data. 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 expos ure. If health effects are not known, this 
shall be stated. 
11.1.6. Symptoms related to the physical, chem ical and toxicological characteristics 
The potential adverse health effects and sy mptoms 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 related to the intended uses spec ified in Subsection 1.2. The first symptoms 
at the lowest exposures through to the cons equences of severe exposure shall be 
described, such as “headaches and dizzine ss 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 whether 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 subs tance or mixture shal l also be provided. 
Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicat ed whether toxicological  data is based on 
human or animal data. 
11.1.8. Interactive effects 
Information on interactions shall be incl uded if relevant and readily available. 
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 specifi c substance or mixtur e are not available, 
data on similar substances or mixtures if  appropriate, may be used. Where specific 
data is not used, or where data are not available, this shal l be clearly stated. 
11.1.10. Mixtures EN 55   EN For a given health effect, if a mixture has not been tested for its health effects as a 
whole, relevant information on relevant s ubstances listed under Section 3 shall be 
provided and the mixture shall be classified  for that effect according to Title II of 
Regulation (EC) No 1272/2008. 
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 different rates of absorption, metabolis m and excretion. As a result, the toxic 
actions may be altered and the overall toxic ity of the mixture may be different from 
that of the substances in it. 
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 presented 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 will occur at the concentrations present, such 
as when a mild irritant is diluted at a cer tain concentration in a non-irritant solution; 
(c) where information on interactions between substances in a mixture is not 
available, assumptions shall not be made and instead the health effects of each 
substance shall be listed separately. 
11.1.12. Other information 
Other relevant information on adverse health  effects shall be included even when not 
required by the classi fication criteria. 
12. SECTION 12: Ecological information 
This section of the safety data sheet sh all describe the information provided to 
evaluate the environmental imp act of the substance or mixture where it is released to 
the environment. Under Subsections 12.1 to  12.6 of the safety data sheet a short 
summary of the data shall be provided incl uding, where available, relevant test data 
and clearly indicating species , media, units, test duratio n and test conditions. This 
information may assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measur es and transport. If it is stated that a 
particular property does not a pply or if information on a pa rticular property is not 
available, the reasons shall be indicated. 
Information on bioaccumulation, persistence and degradability shall be given, where 
available and appropriate, for each relevant substance in the mixture. Information shall also be provided fo r hazardous transformation products arising from the 
degradation of substances and mixtures. 
The information in this section shall be c onsistent with the information provided in a 
registration and/or in a chemical safe ty report where required, and with the 
classification of the substance or mixture. EN 56   EN 12.1. Toxicity 
Information on toxicity using data from te sts performed on aquatic and/or terrestrial 
organisms shall be provided when availabl e. This shall include relevant available 
data on aquatic toxicity, both acute and chronic for fish, cr ustaceans, algae and other 
aquatic plants. In addition, toxicity data on soil micr o and macro-organisms and 
other environmentally relevant organisms, su ch as birds, bees and plants, shall be 
included when available. Where the substa nce or mixture has inhibitory effects on 
the activity of micro-organism s, the possible impact on sewage treatment plants shall 
be mentioned. 
For substances subject to re gistration, summaries of the information derived from the 
application of Annexes VII to XI shall be included. 
12.2. Persistence and degradability 
Persistence and degradability is the potenti al for the substance or the appropriate 
substances in a mixture to degrade in th e environment, either  through biodegradation 
or other processes such as ox idation or hydrolysis. Test results relevant to assess 
persistence and degradab ility shall be given where availa ble. If degrada tion half-lives 
are quoted it must be indicated whether thes e half lives refer to mineralisation or to 
primary degradation. The poten tial of the substance or certain substances in a 
mixture to degrade in sewage treatm ent plants shall also be mentioned. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. 
12.3. Bioaccumulative potential 
Bioaccumulative potential is the potential of the substance or certain substances in a 
mixture to accumulate in biota and, eventu ally, to pass through the food chain. Test 
results relevant to assess the bioaccumulative potential shall be given. This shall include reference to the octanol-wat er partition coefficient (Kow) and 
bioconcentration factor (BCF), if available. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. 
12.4. Mobility in soil 
Mobility in soil is the potential of the substance or the constituents 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 can  be determined from relevant mobility 
data such as adsorption studies or leachi ng studies, known or pred icted distribution to 
environmental compartments, or surface te nsion. For example, Koc values can be 
predicted from octanol/water partition coe fficients (Kow). Leaching and mobility can 
be predicted from models. 
This information shall be given where avai lable and appropriate, for each individual 
substance in the mixture which is required to be listed in Section 3 of this Annex. EN 57   EN Where experimental data is available, that  data shall, in general, take precedence 
over models and predictions. 
12.5. Results of PBT and vPvB assessment 
Where a chemical safety report is requ ired, the results of the PBT and vPvB 
assessment as set out in the chemi cal safety report shall be given. 
12.6. Other adverse effects 
Information on any other adverse effects on the environment shall be included where 
available, such as environmental fate  (exposure), photoche mical ozone creation 
potential, ozone depletion pot ential, endocrine disruptin g potential and/or global 
warming potential.  
13. SECTION 13: Disposal considerations 
This section of the safety data sheet shall describe information for proper waste 
management of the substance or mixture and/or its container to assist in the 
determination of safe and environmenta lly preferred waste management options, 
consistent with the requirements in acco rdance with Directive 2008/98/EC of the 
European Parliament and of the Council24 of the Member State in which the safety 
data sheet is bei ng supplied. Information relevant  for the safety of persons 
conducting waste management activities sha ll complement the information given in 
Section 8. 
Where a chemical safety report is required, the information on the waste 
management measures 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. 
13.1. Waste treatment methods 
(a) Waste treatment containers and met hods shall be specified including the 
appropriate methods of waste treatment of  both the substance or mixture and any 
contaminated packaging (for example incineration, recycling, landfilling); 
(b) Physical/chemical properties that may affect waste treatment options shall be 
specified; 
(c) Sewage disposal shall be discouraged; 
(d) Where appropriate, any special precau tions for the chosen waste treatment 
option shall be identified. 
Any relevant Community provisions relating to waste shall be referred to. In their 
absence any relevant national or regional pr ovisions in force shall be referred to. 
                                                
 
24 OJ L 312, 22.11.2008, p. 3.  EN 58   EN 14. SECTION 14: Transport information 
This section of the safety data sheet shall provide basic classification information for 
transporting/shipment of substances or mi xtures mentioned under Section 1 by road, 
rail, sea, inland waterways or air. Where information is not available or relevant this shall be stated. 
Where relevant, it shall provide information on the transport classification for each of 
the UN Model Regulations: European Ag reement concerning the International 
Carriage of Dangerous Goods by Road (ADR)
25, Regulations concerning the 
International Carriage of Da ngerous Goods by Rail (RID)26, European Agreement 
concerning the Internationa l Carriage of Dangerous Goods by Inland  Waterways 
(ADN)27, all three of which have been implemented by Directive 2008/68/ECof the 
European Parliament and of the Council on the inland tran sport of dangerous 
goods28, International Maritime Da ngerous Goods (IMDG) Code29 (sea), and 
Technical Instructions fo r the Safe Transport of Dangerous Goods by Air (ICAO)30 
(air). 
14.1. UN number 
The UN number (i.e. the four-figure identifi cation number of the substance, mixture 
or article) from the UN Model Re gulations shall be provided. 
14.2. UN proper shipping name 
The UN proper shipping name from the UN Model Regulations shall be provided, 
unless it has appeared as the pr oduct identifier in Subsection 1.1. 
14.3. Transport hazard class(es) 
The transport hazard class (and subsidiary  risks) assigned to the substances or 
mixtures according to the predominant haza rd that they present in accordance with 
the UN Model Regulations shall be provided. 
14.4. Packing group 
The packing group number from the UN M odel Regulations shal l be provided, if 
applicable. The packing group number is  assigned to certain  substances in 
accordance with their degree of hazard. 
                                                 
25 United Nations, Economic Commission for Europe, version applicable as from 1 January 2009, ISBN-
978-92-1-139131-2. 
26 Annex 1 to Appendix B (Uniform Rules concerning the Contract for International Carriage of Goods by 
Rail) of the Convention concerning International Carr iage by Rail, version with effect from 1 January 
2009. 
27 Version as revised as of 1 January 2007. 
28 OJ L 260, 30.09.2008, p. 13. 
29 International Maritime Organisation, 2006 edition, ISBN 978-92-8001-4214-3. 
30 IATA, 2007-2008 edition. EN 59   EN 14.5. Environmental hazards 
It shall be indicated whether the substanc e or mixture is environmentally hazardous 
according to the criteria of the UN Model Regulations (as reflected in the IMDG Code, ADR, RID and ADN) and /or a marine pollutant according to the IMDG Code. If authorized for, or intende d to, carriage by inland waterw ays in tank-vessels, it shall 
be indicated whether the substance or mixt ure is environmentally  hazardous in tank-
vessels only according to ADN. 
14.6. Special precautions for user 
Information shall be provided on any speci al precautions, which a user must be 
aware of, or must comply with, in connect ion with transport or conveyance either 
within or outside his premises. 
14.7. Transport in bulk according to Annex II of MARPOL 73/78
 and the IBC Code  
This subsection only applies when cargoes are intended to be  carried in bulk 
according to the following International Ma ritime Organisation (IMO) instruments: 
Annex II of the Intern ational Convention for the Preven tion of Pollution from Ships, 
1973, as modified by the Protocol of  1978 relating thereto (MARPOL 73/78)31 and 
the International Code for the Constr uction and Equipment of Ships carrying 
Dangerous Chemicals in Bulk (Internat ional Bulk Chemical Code) (IBC Code)32. 
The product name shall be provided (if name is different to 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 Environment Protection Committee 
(MEPC).2/Circular
33. Ship type required and pollu tion category shall be indicated. 
15. SECTION 15: Regulatory information 
This section of the safety data sheet sha ll describe the other regulatory information 
on the substance or mixture that is not alre ady provided in the safety data sheet (such 
as whether the substance or mixture is subject to Regulation (EC) No 2037/2000 of 
the European Parliament and of the Council of 29 June 2000 on substances that deplete the ozone layer
34, Regulation (EC) No 850/2004 of  the European Parliament 
and of the Council of 29 April 2004 on pers istent organic pollutants and amending 
Directive 79/117/EEC35 or Regulation (EC) No 689/2008 of the European Parliament 
and of the Council of 17 June 2008 concer ning the export and import of dangerous 
chemicals36). 
                                                 
31 MARPOL 73/78 – Consolidated edition 2006, London, IMO 2007, ISBN 978-92-801-4216-7. 
32 IBC Code, 2007 edition, London, IMO 2007, ISBN 978-92-801-4226-6. 
33 OJ L 244, 29.9.2000, p. 1. 
34 OJ L 244, 29.9.2000, p. 1. 
35 OJ L 229, 30.4.2004, p. 5. 
36 OJ L 204, 31.7.2008, p. 1. EN 60   EN 15.1. Safety, health and environmental reg ulations/legislation specific for the 
substance or mixture 
Relevant Community safety, health and e nvironmental provisions (for example the 
SEVESO-category) or national information on the regulatory status of the substance 
or mixture (including the substances in the mixture) shall be provided. Where 
relevant the national laws of the relevant Member States which implement these provisions and any other national measures th at may be relevant shall be mentioned. 
If the substance or mixture covered by this sa fety data sheet is the subject of specific 
provisions in relation to protection of human health or the environment at 
Community level (such as aut horisations given under Titl e VII or restrictions under 
Title VIII) these provisions shall be mentioned and any authorisation number shall be 
provided. 
15.2. Chemical Safety Assessment 
It shall be indicated if a chemical safety  assessment has been carried out for the 
substance or the mixture by the supplier. 
16. SECTION 16: Other information 
This section of the safety data sheet shal l describe the informa tion relevant to the 
compilation of the safety data sheet. It shall incorporate other information that does not belong in Sections 1 to 15, including in formation on revision of the safety data 
sheet such as: 
(a) in case of a revised safety data sheet,  a clear indication of where changes have 
been made to the previous version of the sa fety 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 s ubstance or mixture shall main tain an explanation of the 
changes and provide it upon request; 
(b) a key or legend to abbreviations and acronyms used in the safety data sheet; 
(c) key literature references and sources for data; 
(d) list of relevant R phrases, hazard statem ents, safety advice and/or precautionary 
statements. Write out the full text of any st atements which are not written out in full 
under Sections 2 and 3; 
(e) training advice. If a supplier of a substance or mixture chooses to identify the classification in 
accordance with Article 31(10) in advance of applying it fully, the supplier of a 
substance or mixture may include th is classification in this section. 
PART B The safety data sheet shall include th e following 16 headings in accordance with 
Article 31(6) and in addition the subheadings also listed: EN 61   EN 1. SECTION 1: Identification of the substance/mixture and of the 
company/undertaking 
1.1. Product identifier 1.2. Relevant identified uses of the substa nce or mixture and uses advised against 
1.3. Details of the supplier of the substance or mixture 1.4. Emergency telephone number 2. SECTION 2: Hazards identification 2.1. Classification of the substance or mixture 2.2. Label elements 2.3. Other hazards 3. SECTION 3: Composition/information on ingredients 3.1. Substances 3.2. Mixtures 4. SECTION 4: First aid measures 4.1. Description of first aid measures 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of immediate medical atte ntion and special treatment needed 
5. SECTION 5: Fire-fighting measures 5.1. Extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Special protective actio ns for fire-fighters 
6. 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 7. SECTION 7: Handling and storage 
7.1. Precautions for safe handling 
7.2. Conditions for safe storage, including any incompatibilities EN 62   EN 7.3. Specific end use(s) 
8. SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls 9. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties 9.2. Other information 10. 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 11. SECTION 11: Toxicological information 11.1. Information on toxicological effects 12. 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. Other adverse effects 13. SECTION 13: Disposal considerations 13.1. Waste treatment methods 14. SECTION 14: Transport information 
14.1. UN number EN 63   EN 14.2. UN proper shipping name 
14.3. Transport hazard class(es) 14.4. Packing group 14.5. Environmental hazards 14.6. Special precautions for user 14.7. Transport in bulk according to Anne x II of MARPOL73/78 and the IBC Code 
15. SECTION 15: Regulatory information 15.1. Safety, health and environmental re gulations/legislation specific for the 
substance or mixture 
15.2. Chemical Safety Assessment 
16. SECTION 16: Other information '