1991L0155 — EN — 19.12.1993 — 001.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE
of5March1991
definingandlayingdownthedetailedarrangementsforthesystemofspecificinformationrelating
todangerouspreparationsinimplementation ofArticle 10ofDirective 88/379/EEC
(91/155/EEC)
(OJ L 76, 22.3.1991, p. 35)
Amended by:
Official Journal
No page date
►M1Commission Directive 93/112/EC of 10 December 1993 L 314 38 16.12.1993
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COMMISSIONDIRECTIVE
of5March1991
definingandlayingdownthedetailedarrangementsforthesystem
ofspecificinformationrelatingtodangerouspreparationsinimple-
mentationofArticle 10ofDirective 88/379/EEC
(91/155/EEC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic
Community,
Having regard to Council Directive 88/379/EEC of 7 June 1988 on the
approximation of the laws, regulations and administrative provisions ofthe Member States relating to the classification, packaging and label-ling of dangerous preparations(
1), as last amended by Commission
Directive 90/492/EEC(2), and in particular Article 10 (2) thereof,
Whereas the labelling required by Directive 88/379/EEC constitutes a
basic source of information for users of dangerous preparations bygiving them a clear, concise indication of the potential dangers;whereas that labelling needs to be supplemented by a more detailedinformation system for industrial users;
Whereas Article 10 of Directive 88/379/EEC provides for the setting
upof an information system in the form of safety data sheets relating
to dangerous preparations; whereas, moreover, this Article specifiesthat such information is principally intended for industrial users andmust enable them to take the measures necessary to ensure the protec-tion of health and safety at the workplace;
Whereas there are close links between Directive 88/379/EEC and
Council Directive 67/548/EEC of 27 June 1967, on the approximation
of laws, regulations and administrative provisions relating to the classi-fication, packaging and labelling of dangerous substances(
3), as last
amended by Directive 79/831/EEC(4); whereas it is therefore desirable
to establish a system of safety data sheets which is applicable to both
dangerous substances and dangerous preparations; whereas the imple-
menting provisions for dangerous substances will be laid down in duecourse;
Whereas the advisory committee on safety, hygiene and health protec-
tion at the workplace set up by Council Decision 74/325/EEC(
5), as
last amended by the Act of Accession of Spain and Portugal, has been
consulted;
Whereas the provisions of this Directive are in accordance with the
opinion of the committee for the adaptation to technical progress ofthe Directives on the removal of technical barriers to trade indangerous substances and preparations,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. Any person established within the Community who is responsible
for placing a dangerous substance or preparation on the market,
whether the manufacturer, importer or distributor, shall supply the reci-pient who is an industrial user of the substance or preparation with asafety date sheet containing the information set out in Article 3.
2. The information shall be provided free of charge at the latest
when the substance or preparation is first supplied and thereafter1991L0155 — EN — 19.12.1993 — 001.001 — 2
(1) OJ No L 187, 16. 7. 1988, p. 14.
(2) OJ No L 275, 5. 10. 1990, p. 35.
(3) OJ No 196, 16. 8. 1967, p. 1.
(4) OJ No L 287, 19. 10. 1990, p. 37.
(5) OJ No L 185, 9. 7. 1974, p. 15.
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following any revision due to any significant new information
regarding safety and protection of health and the environment.
The new dated version, identified as ‘Revision: … (date)’ shall be
provided free of charge to all former recipients who received thesubstance or preparation within the preceding 12 months.
3. The safety data sheet need not be supplied where dangerous
substances or preparations offered or sold to the general public are
furnished with sufficient information to enable users to take the neces-
sary measures as regards the protection of health and safety. However,a safety data sheet must be supplied at the request of an industrial user.
Article 2
Member States may make the placing of dangerous substances or
preparations on the market in their territory subject to the use of their
official language or languages for the compilation of the safety datasheet referred to in Article 1.
Article 3
The safety data sheet referred to in Article 1 shall contain the following
obligatory headings:
1. identification of the substance/preparation and of the company/
undertaking;
2. composition/information on ingredients;3. hazards identification;
4. first-aid measures;
5. fire-fighting measures;6. accidental release measures;
7. handling and storage;
8. exposure controls/personal protection;9. physical and chemical properties;
10. stability and reactivity;
11. toxicological information;12. ecological information;13. disposal considerations;
14. transport information;
15. regulatory information;16. other information.
It shall be incumbent on the person responsible for placing the
substance or preparation on the market to supply the information speci-fied under these headings. This information shall be compiled inaccordance with the Explanatory Notes in the Annex. The safety data
sheet shall be dated.
Article 5
1. Member States shall adopt and publish the provisions necessary
to comply with this Directive by 30 May 1991 at the latest and shallforthwith inform the Commission thereof.
2. These provisions shall take effect from 8 June 1991.
However, existing information systems of the safety data sheet type in
use in some Member States may continue to be used until 30 June1993.
3. When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such reference at1991L0155 — EN — 19.12.1993 — 001.001 — 3
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the time of their official publication. The procedure for such reference
shall be adopted by Member States.
Article 6
This Directive is addressed to the Member States.1991L0155 — EN — 19.12.1993 — 001.001 — 4
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ANNEX
GUIDETOTHECOMPILATIONOFSAFETYDATASHEETS
The following explanatory notes are intended as a guide. Their purpose is to
ensure that the content of each of the mandatory headings listed in Article 3
will enable professional users to take the necessary measures relating to protec-
tion of health and safety at the workplace, and to protect the environment.
The information must be written in a clear and concise manner.
Additional information may prove necessary in some cases in view of the wide
range of properties of the substances and preparations. If in other cases it
emerges that information from certain properties is of no significance or that it
is technically impossible to provide the reasons for this must be clearly stated.
Although the order of headings is not obligatory, the sequence given in Article 3
is recommended.
When a safety data sheet has been revised, the changes should be brought to the
attention of the recipient.
1.Identification of the substance/preparation and of the company/under-
taking
1.1.Identification of the substance or preparation:
The term used for identification must be identical to that provided on the
label as set out in Annex VI to Directive 67/548/EEC.
Other means of identification available may also be indicated.
1.2.Company/undertaking identification:
— identification of the person established within the Community respon-
sible for placing the substance or preparation on the market whether it
be the manufacturer, importer or distributor,
— full address and telephone number of this person.
1.3. In addition to the abovementioned information, supply the emergency tele-
phone number of the company and/or official advisory body in accordance
with Article 12 of Directive 88/379/EEC.
2.Composition/informationoningredients
The information given should enable the recipient to identify readily the
risks attached to the substance or preparation.
In the case of a preparation:
(a) it is not necessary to give the full composition (nature of the ingredi-
ents and their concentration);
(b) however, the following substances shall be indicated, together with
their concentration or concentration range, if they are present in
concentrations equal to or greater than those laid down in Article 3
(6) (a) of Directive 88/379/EEC (unless a lower limit is considered
more appropriate):
— substances presenting a health hazard within the meaning of Direc-
tive 67/548/EEC,
and
— at least substances subject to recognized exposure limit values
pursuant to Community provisions but which are not covered by
the above Directive;
(c) the classification (either from Article 6 of or Annex I to Directive 67/
548/EEC) of the above substances shall be given in the form of the
symbols and R phrases which are assigned in accordance with their
health hazards;
(d) if, in accordance with the provisions of Article 7 (1) of Directive 88/
379/EEC, the identity of certain substances is to be kept confidential,
their chemical nature shall be described in order to ensure safe hand-
ling. The name must be the same as that which derives from the
above procedure.1991L0155 — EN — 19.12.1993 — 001.001 — 5
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3.Hazardsidentification
Indicate clearly and briefly the most important hazards the substance or
preparation presents, in particular the critical hazards to man and the envir-
onment.
Describe the most important adverse human health effects and symptoms
relating to the uses and possible misuses of the substance or preparation
that can be reasonably foreseen.
The information should be compatible with that shown on the product label
but need not repeat it.
4.First-aidmeasures
Describe the first-aid measures; however, it is important to specify whether
immediate medical attention is required.
The information on first aid must be brief and easy to understand by the
victim, bystanders and first aiders. The symptoms and effects should be
briefly summarized. The instructions should indicate what is to be done
on the spot in the case of an accident and whether delayed effects can be
expected after exposure.
Subdivide the information according to the different routes of exposure, i.
e. inhalation, skin and eye contact and ingestion, under different subhead-
ings.
Indicate whether professional assistance by a doctor is needed or advisable.
For some substances or preparations it may be important to emphasize that
special means to provide specific and immediate treatment must be avail-
able at the workplace.
5.Fire-fighting measures
Refer to requirements for fighting a fire caused by the substance or
preparation, or arising in its vicinity by indicating:
— suitable extinguishing media,
— extinguishing media which must not be used for safety reasons,
— special exposure hazards arising from the substance or preparation
itself, combustion products, resulting gases,
— special protective equipment for fire-fighters.
6.Accidentalreleasemeasures
Depending on the substance or preparation involved, information may be
needed on:
—personal precautions such as:
removal of ignition sources, provision for sufficient ventilation/respira-
tory protection, control of dust, prevention of skin and eye contact,
—environmental precautions such as:
keeping away from drains, surface- and ground-water and soil, possible
need to alert the neighbourhood,
—methods for cleaning up such as:
use of absorbant material (e. g. sand, diatonic soil, acid binder,
universal binder, sawdust …) reduction of gases/fumes with water, dilu-
tion.
Also consider the need for indications such as: ‘never use, neutralize
with, …’.
NB:If appropriate refer to points 8 and 13.
7.Handlingandstorage
7.1.Handling
Consider precautions for safe handling including advice on technical
measures such as: local and general ventilation, measures to prevent aerosol
and dust generation and fire, and any specific requirement or rules relating
to the substance or preparation (e. g. procedures or equipment which are
prohibited or recommended) and if possible give a brief description.
7.2.Storage
Consider the conditions for safe storage such as: specific design for storage
rooms or vessels (including retention walls and ventilation), incompatible1991L0155 — EN — 19.12.1993 — 001.001 — 6
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materials, conditions of storage (temperature and humidity limit/range,
light, inert gas …), special electrical equipment and prevention of static
electricity.
Give advice if relevant on quantity limits under storage conditions. In parti-
cular indicate any special requirements such as the type of material used in
the packaging/containers of the substance or preparation.
8.Exposurecontrols/personalprotection
For the purposes of this document exposure control means the full range of
precautionary measures to be taken during use in order to minimize worker
exposure.
Engineering measures should be taken before personal protection equip-
ment is necessary. Therefore give information on the system design, e. g.
enclosure. This information should complement that already given to point
7.1.
Indicate, with their reference, any specific control parameters such as limit
values or biological standards. Give information on the recommended
monitoring procedures and indicate the reference.
Where personal protection is needed, specify the type of equipment to
provide adequate and suitable protection:
—respiratoryprotection:
in the case of dangerous gases, vapours or dust, consider the need for
appropriate protectice equipment, such as self-contained breathing appa-
ratus, adequate masks and filters,
—hand protection:
specify the type of gloves to be worn when handling the substance or
preparation. If necessary indicate any additional skin and hand protec-
tion measures,
—eye protection:
specify the tpye of eye protection equipment required such as: safety
glasses, safety goggles, face shield,
—skin protection:
If it is necessary to protect a part or the body other than the hands,
specify the type and quality of protection equipment required, such as:
apron, boots and full protective suit. If necessary, indicate specific
hygiene measures.
Reference shall be made where appropriate to the relevant CEN standards.
9.Physicalandchemical properties
This section includes the following information, where applicable, on the
substances or preparation.
Appearance: indicate the physical state (solid, liquid,
gas) and the colour of the substance ofpreparation as supplied.
Odour: if odour is perceptible, give a brief
description of it.
pH: indicate the pH of the substance or
preparation as supplied or of an
aqueous solution; in the latter case,
indicate the concentration.
Boiling point/boiling range:
Within the meaning of Directive 67/
548/EEC/C148/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C147/C150Melting point/melting range:
Flash point:Flammability(solid, gas):Autoflammability:Explosive properties:Oxidizing properties:Vapour pressure:Relative density:Solubility: —water solubility
—fat solubility(solvent-oil to
be specified):
Partition coefficient: n-octanol/water:1991L0155 — EN — 19.12.1993 — 001.001 — 7
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Other data: indicate important safety parameters,
such as vapour density, miscibility,
evaporation rate, conductivity, visc-osity, etc.
The above properties should be determined in accordance with the specifi-
cations of Part A of Annex V to Directive 67/548/EEC or any other
comparable method.
10.Stabilityandreactivity
State the stability of the substance or preparation and the possibility of
hazardous reactions occurring under certain conditions.
Conditions to avoid:List those conditions such as temperature, pressure, light, shock, etc., which
may cause a dangerous reaction and if possible give a brief description.
Materials to avoid:List materials such as water, air, acids, bases, oxidizing agents or any other
specific substance which may cause a dangerous reaction and if possible
give a brief description.
Hazardous decomposition products:List hazardous materials produced in dangerous amounts upon decomposi-
tion.
N.B.Address specifically:
— the need for and the presence of stabilizers,
— the possibility of a hazardous exothermic reaction,
— safety significance, if any, of a change in physical appearance of
the substance or preparation,
— hazardous decomposition products, if any, formed upon contact
with water,
— possibility of degradation to unstable products.
11.Toxicological information
This section deals with the need for a concise but complete and compre-
hensible description of the various toxicological (health) effects which can
arise if the user comes into contact with the substance or preparation.
Include dangerous-to-health effects from exposure to the substance or
preparation, based on both experiences and conclusions from scientific
experiments. Include information on the different routes of exposure (inha-
lation, ingestion, skin and eye contact), and describe the symptoms related
to the physical, chemical and toxicological characteristics.
Include known delayed and immediate effects and also chronic effects from
short- and long-term exposure: for example sensitization, carcinogenicity,
mutagenicity and reproductive toxicity including teratogenicity and
narcosis.
Taking account of the information already provided under point 2, ‘Compo-
sition/information on ingredients’, it may be necessary to make reference to
specific health effects of certain components in preparations.
12.Ecological information
Identify effects, behaviour and environmental fate owing to the nature of
the substance or preparation and its reasonably foreseeable uses. Informa-
tion of the same kind shall be supplied for dangerous products arising
from the degradation of substances and preparations.
Examples of relevant ecological information are listed below:
mobility: — known or predicted distribution to
environmental compartments,
— surface tension,— absorption/desorption,
— other physical-chemical properties, see
section 9;1991L0155 — EN — 19.12.1993 — 001.001 — 8
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degradability: — biotic and abiotic degradation,
— aerobic and anaerobic degradation,— persistence;
accumulation: — bioaccumulation potential,
— biomagnification;
Short and long term effects on:
ecotoxicity: — aquatic organisms,
— soil organisms,— plants and terrestrial animals;
other adverse effects: — ozone depletion potential,
— photochemical ozone creation potential,
— global warming potential,— effects on waste water treatment plants;
Remarks
Ensure that information relevant to the environment is provided in other
sections of the safety data sheet, especially advice for controlled release,
accidental release measures and disposal considerations in points 6, 7, 13
and 15.
Pending criteria for evaluation of the environmental impact of a prepara-
tion, information relating to the factors above shall be given for
substances classified as dangerous for the environment which are present
in the preparation.
13.Disposalconsiderations
If the disposal of the substance or preparation (surplus or waste resulting
from the foreseeable use) presents a danger, a description of these residues
and information on their safe handling shall be given.
Indicate the appropriate methods of disposal of both the substance or
preparation and any contaminated packaging (incineration, recycling, land-
filling, etc.).
Comment
Refer to any Community provisions relating to waste. In their absence, it is
useful to remind the user that national or regional provisions may be in
force.
14.Transportinformation
Indicate any special precautions which a user needs to be aware of or needs
to comply with in connection with transport or conveyance either within or
outside his premises.
Additional information provided for by the United Nations recommendation
and other international agreements on the transport and packaging of
dangerous goods may also be given.
15.Regulatoryinformation
Give the information on the label according to the Directives relating to the
classification, packaging and labelling of dangerous substances and
preparations.
If the substance or preparation covered by this safety data sheet is the
subject of specific provisions in relation to protection of man or the envir-
onment at Community level (e.g. restrictions on marketing and use, limit
values for exposure at the place of work) these provisions should, as far
as possible, be stated. The attention of recipients should also be drawn to
the existence of national laws that implement these provisions.
It is also recommended that the data sheet should remind recipients to refer
to any other national measures that may be relevant.1991L0155 — EN — 19.12.1993 — 001.001 — 9
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16.Otherinformation
Indicate any other information which might be of importance for safety and
health and for the protection of the environment, for example:
— training advice,
— recommended uses and restrictions,— further information (written reference and/or technical contact point),— sources of key data used to compile the data sheet.
Also give the date of issue of the data sheet, if not stated elsewhere.1991L0155 — EN — 19.12.1993 — 001.001 — 10