Directive 2003/105/EC of the European Parliament and of the Council of 16 December 2003 amending Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances
Date: 2003-12-16
Institutions: Council of the European Union, European Parliament
Subjects: dangerous substance, environmental risk prevention, exchange of information, industrial hazard, public health, safety standard

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DIRECTIVE 2003/105/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 16 December 2003

amending Council Directive 96/82/EC on the control of major-accident hazards involving
dangerous substances

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Economic and
Social Committee (2),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty in the light of the joint text approved by the
Conciliation Committee on 22 October 2003 (3),

Whereas:

(1)

(2)

(3)

Directive 96/82/EC (4) aims at the prevention of major
accidents which involve dangerous substances and the
limitation of their consequences for man and the envir-
onment, with a view to ensuring high levels of protec-
tion throughout the Community in a consistent and
effective manner.

In the light of recent industrial accidents and studies on
carcinogens and substances dangerous for the environ-
ment carried out by the Commission at the Council's
request,
the scope of Directive 96/82/EC should be
extended.

The cyanide spill that polluted the Danube following the
accident at Baia Mare in Romania in January 2000 has
demonstrated that certain storage and processing activ-
facilities,
ities in mining, especially tailings disposal
including tailing ponds or dams, have potential
to
produce very serious consequences. The Commission
communications on the safe operation of mining activ-
ities and on the sixth environment action programme of
the European Community have therefore highlighted the
need for an extension of the scope of Directive 96/82/
EC. In its resolution of 5 July 2001 (5) on the Commis-
sion Communication on the safe operation of mining
activities, the European Parliament also welcomed the
extension of the scope of that Directive to cover risks
arising from storage and processing activities in mining.

(1) OJ C 75 E, 26.3.2002, p. 357 and OJ C 20 E, 28.1.2003, p. 255.
(2) OJ C 149, 21.6.2002, p. 13.
(3) Opinion of the European Parliament of 3 July 2002 (OJ C 271 E,
12.11.2003, p. 315), Council common position of 20 February
2003 (OJ C 102 E, 29.4.2003, p. 1) and position of the European
Parliament of 19 June 2003 (not yet published in the Official
Journal). Legislative resolution of the European Parliament of 19
November 2003 (not yet published in the Official Journal) and deci-
sion of the Council of 1 December 2003.

(4) OJ L 10, 14.1.1997, p. 13.
(5) OJ C 65 E, 14.3.2002, p. 382.

(4)

(5)

(6)

(7)

(8)

(9)

The proposal
for a directive on the management of
waste from the extractive industries may be a relevant
framework for measures relating to those waste manage-
ment facilities which present an accident risk but which
are not covered by the present Directive.

The ‘fireworks accident’ at Enschede in the Netherlands
in May 2000 has demonstrated the major accident
potential arising from storage and manufacture of pyro-
technic and explosive substances. The definition of such
substances in Directive 96/82/EC should therefore be
clarified and simplified.

The explosion at a fertiliser plant
in Toulouse in
September 2001 has raised awareness of the accident
potential arising from the storage of ammonium nitrate
and ammonium nitrate-based fertilisers, in particular of
material rejected during the manufacturing process or
returned to the manufacturer (off-specs). The existing
categories of ammonium nitrate and ammonium nitrate-
based fertilisers in Directive 96/82/EC should therefore
be reviewed with a view to include ‘off-specs’ material.

Directive 96/82/EC should not be applied to sites of
end-users where ammonium nitrate and ammonium
nitrate-based fertilisers, which on delivery conformed to
the specification in that Directive but subsequently have
become degraded or contaminated, are temporarily
present prior to removal for reprocessing or destruction.

Studies carried out by the Commission in close coopera-
tion with the Member States support extending the list
of carcinogens with appropriate qualifying quantities
and significantly lowering the qualifying quantities
assigned to substances dangerous for the environment in
Directive 96/82/EC.

For establishments which subsequently fall within the
scope of Directive 96/82/EC, it has been shown neces-
sary to introduce minimum periods for notifications and
the establishment of major accident prevention policies,
safety reports and emergency plans.

(10)

The experience and knowledge of relevant staff in the
establishment can greatly assist in the drawing up of
emergency plans, and all staff in an establishment and
persons likely to be affected should be appropriately
informed on safety measures and actions.

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(11)

(12)

(13)

(14)

(15)

adoption of Council Decision 2001/792/EC,
The
Euratom of 23 October 2001 establishing a Community
mechanism to facilitate reinforced cooperation in civil
protection assistance interventions (1) highlights the need
to facilitate reinforced cooperation in civil protection
assistance interventions.

It is useful, in order to facilitate land-use planning, to
draw up guidelines defining a database to be used for
assessing the compatibility between the establishments
covered by Directive 96/82/EC and the areas described
in Article 12(1) of that Directive.

There should be an obligation on Member States to
supply the Commission with minimum information
concerning the establishments covered by Directive 96/
82/EC.

is appropriate at

It
passages in Directive 96/82/EC.

the same time to clarify certain

The measures provided for in this Directive have been
the subject of a public consultation process involving
interested parties.

(16) Directive 96/82/EC should therefore be amended accord-

ingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/82/EC is hereby amended as follows:

1. Article 4 is amended as follows:

(a) Points (e) and (f) are replaced by the following:

‘(e) the

exploitation (exploration,

extraction and
processing) of minerals in mines, quarries, or by
means of boreholes, with the
exception of
chemical and thermal processing operations and
storage related to those operations which involve
dangerous substances, as defined in Annex I;

(f) the offshore

exploration and exploitation of

minerals, including hydrocarbons;’

(b) The following point shall be added:

‘(g) waste land-fill sites, with the exception of opera-
including tailing
tional tailings disposal facilities,
ponds or dams, containing dangerous substances
as defined in Annex I, in particular when used in
connection with the chemical and thermal proces-
sing of minerals.’

2. Article 6 is amended as follows:

(a) The following indent is added in paragraph 1:

‘— for establishments which subsequently fall within
the scope of this Directive, within three months
after the date on which this Directive applies to
the establishment concerned, as laid down in the
first subparagraph of Article 2(1).’

(1) OJ L 297, 15.11.2001, p. 7.

(b) The following indent is inserted after the first indent of

Article 6(4):

‘— modification of an establishment or an installation
repercussions on

which could have significant
major accident hazards, or’.

3. The following paragraph is inserted in Article 7:

For establishments which subsequently fall within
‘1a.
the scope of this Directive, the document referred to in
paragraph 1 shall be drawn up without delay, but at all
events within three months after the date on which this
Directive applies to the establishment concerned, as laid
down in the first subparagraph of Article 2(1).’

4. Article 8(2)(b) is replaced by the following:

‘(b) provision is made for cooperation in informing the
public and in supplying information to the authority
responsible for the preparation of external emergency
plans.’

5. Article 9 is amended as follows:

(a) The first subparagraph of paragraph 2 is replaced by

the following:

‘2.
The safety report shall contain at least the data
and information listed in Annex II. It shall name the
relevant organisations involved in the drawing up of
the report. It shall also contain an updated inventory
of the dangerous substances present in the establish-
ment.’

(b) The following indent is inserted between the third and

fourth indents of paragraph 3:

‘— for establishments which subsequently fall within
the scope of this Directive, without delay, but at all
events within one year after the date on which this
Directive applies to the establishment concerned,
as laid down in the first subparagraph of Article
2(1).’

(c) In paragraph 4, the reference to ‘the second, third, and
fourth indents’ becomes ‘the second, third, fourth and
fifth indents’ respectively.

(d) The following point is added to Article 9(6):

‘(d) The Commission is

invited to review by 31
December 2006 in close cooperation with the
Member States,
the existing “Guidance on the
Preparation of a Safety Report”.’

6. Article 11 is amended as follows:

(a) The following indent is added to points (a) and (b) of

paragraph 1:

‘— for establishments which subsequently fall within
the scope of this Directive, without delay, but at all
events within one year after the date on which this
Directive applies to the establishment concerned,
as laid down in the first subparagraph of Article
2(1).’

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(b) Paragraph 3 is replaced by the following:

‘3. Without prejudice to the obligations of
the
competent authorities, Member States shall ensure that
the internal emergency plans provided for in this
Directive are drawn up in consultation with the
personnel working inside the establishment, including
long-term relevant subcontracted personnel, and that
the public is consulted on external emergency plans
when they are established or updated.’

(c) The following paragraph is inserted:

emergency plans,
‘4a. With regard to external
Member States should take into account the need to
facilitate enhanced cooperation in civil protection assis-
tance in major emergencies.’

7. Article 12 is amended as follows:

(a) The second subparagraph of paragraph 1 is replaced

by the following:

‘Member States shall ensure that their land-use and/or
other relevant policies and the procedures for imple-
menting those policies take account of the need, in the
long term, to maintain appropriate distances between
establishments covered by this Directive and residential
areas, buildings and areas of public use, major trans-
port routes as far as possible, recreational areas and
areas of particular natural sensitivity or interest and, in
the case of existing establishments, of the need for
additional
in accordance with
Article 5 so as not to increase the risks to people.’

technical measures

(b) The following paragraph is inserted:

The Commission is invited by 31 December
‘1a.
2006, in close cooperation with the Member States, to
draw up guidelines defining a technical database
including risk data and risk scenarios, to be used for
assessing the compatibility between the establishments
covered by this Directive and the areas described in
paragraph 1. The definition of this database shall as far
as possible take account of the evaluations made by
the competent authorities, the information obtained
from operators and all other relevant information such
as the socioeconomic benefits of development and the
mitigating effects of emergency plans.’

8. Article 13 is amended as follows:

(a) The first subparagraph of paragraph 1 is replaced by

the following:

‘1. Member States shall ensure that information on
safety measures and on the requisite behaviour in the
event of an accident is supplied regularly and in the
most appropriate form, without their having to request
it, to all persons and all establishments serving the

liable to be
public (such as schools and hospitals)
affected by a major accident originating in an establish-
ment covered by Article 9.’

(b) Paragraph 6 is replaced by the following:

‘6.
to the
In the case of establishments subject
provisions of Article 9, Member States shall ensure that
the inventory of dangerous substances provided for in
Article 9(2) is made available to the public subject to
this Article and
the provisions of paragraph 4 of
Article 20.’

9. The following paragraph is inserted in Article 19:

For

establishments

‘1a.
covered by this Directive,
Member States shall supply the Commission with at least
the following information:

(a) the name or trade name of the operator and the full

address of the establishment concerned; and

(b) the activity or activities of the establishment.

The Commission shall set up and keep up to date a data-
base containing the information supplied by the Member
States. Access to the database shall be reserved to persons
authorised by the Commission or the competent authori-
ties of the Member States.’

10. Annex I is amended as set out in the Annex.

11. In Annex II, point IV part B is replaced by the following:

‘B. Assessment of the extent and severity of the conse-
quences of identified major accidents including maps,
images or, as appropriate, equivalent descriptions,
showing areas which are liable to be affected by such
accidents arising from the establishment, subject to the
provisions of Articles 13(4) and 20.’

12. In Annex III, point (c) is amended as follows:

(a) point (i) is replaced by the following:

‘(i) organisation and personnel — the

roles and
responsibilities of personnel
involved in the
management of major hazards at all levels in the
organisation. The identification of training needs of
such personnel and the provision of the training so
identified. The involvement of employees and of
subcontracted personnel working in the establish-
ment.’

(b) point (v) is replaced by the following:

‘(v) Planning for emergencies — adoption and imple-
mentation of procedures to identify foreseeable
emergencies by systematic analysis, to prepare, test
and review emergency plans to respond to such
emergencies and to provide specific training for
the staff concerned. Such training shall be given to
establishment,
all personnel working
including relevant subcontracted personnel.’

in the

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Article 2

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive before 1 July 2005. They shall forthwith inform the
Commission thereof.

When Member States adopt these measures, they shall contain
a reference to this Directive or shall be accompanied by such a
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

This Directive shall enter into force on the day of its publica-
tion in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 16 December 2003.

For the European Parliament

The President

P. COX

For the Council

The President

G. ALEMANNO

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Annex I to Directive 96/82/EC is hereby amended as follows:

1. The following points are added to the introduction:

ANNEX

‘6. For the purposes of this Directive, a gas is any substance that has an absolute vapour pressure equal to or greater

than 101,3 kPa at a temperature of 20 ° C.

7. For the purposes of this Directive, a liquid is any substance that is not defined as a gas and that is not in the solid

state at a temperature of 20 ° C and at a standard pressure of 101,3 kPa.’

2. In the table in Part 1:

(a) the entries relating to ‘Ammonium nitrate’ are replaced by the following:

‘Ammonium nitrate (see note 1)

Ammonium nitrate (see note 2)

Ammonium nitrate (see note 3)

Ammonium nitrate (see note 4)

5 000

1 250

350

10

(b) the following entries are inserted after the entries relating to ‘Ammonium nitrate’:

‘Potassium nitrate (see note 5)

Potassium nitrate (see note 6)

5 000

1 250

(c) the entry relating to ‘The following CARCINOGENS’ is replaced by the following:

10 000

5 000

2 500

50’

10 000

5 000’

0,5

2’

‘The following CARCINOGENS at concentrations above
5 % by weight:
4-Aminobiphenyl and/or
salts, Benzotrichloride,
its
Benzidine and/or salts, Bis (chloromethyl) ether, Chlor-
omethyl methyl ether, 1,2-Dibromoethane, Diethyl
sulphate, Dimethyl
sulphate, Dimethylcarbamoyl
chloride, 1,2-Dibromo-3-chloropropane, 1,2-Dimethyl-
hydrazine,
Hexamethylpho-
sphoric triamide, Hydrazine, 2- Naphthylamine and/or
salts, 4-Nitrodiphenyl, and 1,3 Propanesultone

Dimethylnitrosamine,

(d) the entry relating to ‘Automotive petrol and other petroleum spirits’ is replaced by the following:

‘Petroleum products:
(a) gasolines and naphthas,
(b) kerosenes (including jet fuels),
(c) gas oils (including diesel fuels, home heating oils

and gas oil blending streams)

(e)

(i) Notes 1 and 2 are replaced by the following:

2 500

25 000’

‘1. Ammonium nitrate (5 000/10 000): fertilisers capable of self-sustaining decomposition

This applies to ammonium nitrate-based compound/composite fertilisers (compound/composite fertilisers
containing ammonium nitrate with phosphate and/or potash) in which the nitrogen content as a result of
ammonium nitrate is

— between 15,75 % (1) and 24,5 % (2) by weight, and either with not more than 0,4 % total combus-

tible/organic materials or which fulfil the requirements of Annex II of Directive 80/876/EEC,

— 15,75 % (3) by weight or less and unrestricted combustible materials,

and which are capable of self-sustaining decomposition according to the UN Trough Test (see United
Nations Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, Part III,
subsection 38.2).

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2. Ammonium nitrate (1 250/5 000): fertiliser grade

This applies to straight ammonium nitrate-based fertilisers and to ammonium nitrate-based compound/
composite fertilisers in which the nitrogen content as a result of ammonium nitrate is

— more than 24,5 % by weight, except for mixtures of ammonium nitrate with dolomite, limestone

and/or calcium carbonate with a purity of at least 90 %,

— more than 15,75 % by weight for mixtures of ammonium nitrate and ammonium sulphate,

— more than 28 % (4) by weight for mixtures of ammonium nitrate with dolomite, limestone and/or

calcium carbonate with a purity of at least 90 %,

and which fulfil the requirements of Annex II of Directive 80/876/EEC.

3. Ammonium nitrate (350/2500): technical grade

This applies to:

— ammonium nitrate and preparations of ammonium nitrate in which the nitrogen content as a result

of the ammonium nitrate is

— between 24,5 % and 28 % by weight, and which contain not more than 0,4 % combustible

substances,

— more than 28 % by weight, and which contain not more than 0,2 % combustible substances,

— aqueous ammonium nitrate solutions in which the concentration of ammonium nitrate is more than

80 % by weight.

4. Ammonium nitrate (10/50): “off-specs” material and fertilisers not fulfilling the detonation test

This applies to:

— material rejected during the manufacturing process and to ammonium nitrate and preparations of
ammonium nitrate, straight ammonium nitrate-based fertilisers and ammonium nitrate-based
compound/composite fertilisers referred to in notes 2 and 3, that are being or have been returned
from the final user to a manufacturer, temporary storage or reprocessing plant for reworking, recy-
cling or treatment for safe use, because they no longer comply with the specifications of Notes 2
and 3;

— fertilisers referred to in note 1, first indent, and Note 2 which do not fulfil the requirements of

Annex II of Directive 80/876/EEC.

5. Potassium nitrate (5 000/10 000): composite potassium-nitrate based fertilisers composed of potassium

nitrate in prilled/granular form.

6. Potassium nitrate (1 250/5 000): composite potassium-nitrate based fertilisers composed of potassium

nitrate in crystalline form.’

(ii) the note relating to polychlorodibenzofurans and polychlorodibenzodioxins becomes note 7.

(iii) the following footnotes appear below the table entitled ‘International Toxic Equivalent Factors (ITEF) for the

congeners of concern (NATO/CCMS)’:

‘(1) 15,75 % nitrogen content by weight as a result of ammonium nitrate corresponds to 45 % ammonium

nitrate.

(2) 24,5 % nitrogen content by weight as a result of ammonium nitrate corresponds to 70 % ammonium

nitrate.

(3) 15,75 % nitrogen content by weight as a result of ammonium nitrate corresponds to 45 % ammonium

nitrate.

(4) 28 % nitrogen content by weight as a result of ammonium nitrate corresponds to 80 % ammonium

nitrate.’

3. In Part 2:

(a) entries 4 and 5 are replaced by the following:

‘4. EXPLOSIVE (see note 2)

where the substance, preparation or article falls
under UN/ADR Division 1.4

5. EXPLOSIVE (see note 2)

where the substance, preparation or article falls
under any of: UN/ADR Divisions 1.1, 1.2, 1.3, 1.5
or 1.6 or risk phrase R2 or R3

50

10

200

50’

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(b) entry 9 is replaced by the following:

‘9. DANGEROUS FOR THE ENVIRONMENT risk

phrases:

i) R50:

toxic
“Very
(including R50/53)

to aquatic

organisms”

ii) R51/53:

“Toxic to aquatic organisms; may
cause long term adverse effects in the aquatic
environment”

100

200

200

500’

(c) In the notes:

(i) Note 1 is replaced by the following:

‘1. Substances and preparations are classified according to the following Directives and their current adapta-

tion to technical progress:

Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and
administrative provisions
classification, packaging and labelling of dangerous
substances(1),

relating to the

Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the
approximation of laws, regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations (2).

In the case of substances and preparations which are not classified as dangerous according to either of
the above directives, for example waste, but which nevertheless are present, or are likely to be present,
in an establishment and which possess or are likely to possess, under the conditions found at the estab-
lishment, equivalent properties in terms of major-accident potential, the procedures for provisional classi-
fication shall be followed in accordance with the relevant article of the appropriate Directive.

In the case of substances and preparations with properties giving rise to more than one classification, for
the purposes of this Directive the lowest qualifying quantities shall apply. However, for the application
of the rule in Note 4, the qualifying quantity used shall always be the one corresponding to the classifica-
tion concerned.

For the purposes of this Directive, the Commission shall establish and keep up to date a list of substances
which have been classified into the above categories by a harmonised Decision in accordance with Direc-
tive 67/548/EEC.’

(ii) Note 2 is replaced by the following:

‘2. An “explosive” means:

— a substance or preparation which creates the risk of an explosion by shock, friction, fire or other

sources of ignition (risk phrase R2),

— a substance or preparation which creates extreme risks of explosion by shock, friction, fire or other

sources of ignition (risk phrase R3), or

— a substance, preparation or article covered by Class 1 of the European Agreement concerning the
International Carriage of Dangerous Goods by Road (UN/ADR), concluded on 30 September 1957,
as amended, as transposed by Council Directive 94/55/EC of 21 November 1994 on the approxima-
tion of the laws of the Member States with regard to the transport of dangerous goods by road (3).

Included in this definition are pyrotechnics, which for the purposes of this Directive are defined as
substances (or mixtures of substances) designated to produce heat, light, sound, gas or smoke or a
combination of such effects through self-sustained exothermic chemical reactions. Where a substance or
preparation is classified by both UN/ADR and risk phase R2 or R3, the UN/ADR classification shall take
precedence over assignment of risk phrases.

Substances and articles of Class 1 are classified in any of the divisions 1.1 to 1.6 in accordance with the
UN/ADR classification scheme. The divisions concerned are:

Division 1.1: “Substances and articles which have a mass explosion hazard (a mass explosion is an
explosion which affects almost the entire load virtually instantaneously).”

Division 1.2: “Substances and articles which have a projection hazard but not a mass explosion
hazard.”

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Division 1.3: “Substances and articles which have a fire hazard and either a minor blast hazard or a
minor projection hazard or both, but not a mass explosion hazard:

(a) combustion of which gives rise to considerable radiant heat; or

(b) which burn one after another, producing minor blast or projection effects or both.”

Division 1.4: “Substances and articles which present only a slight risk in the event of ignition or initia-
tion during carriage. The effects are largely confined to the package and no projection of fragments of
appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous
explosion of virtually the entire contents of the package.”

Division 1.5: “Very insensitive substances having a mass explosion hazard which are so insensitive that
there is very little probability of initiation or of transition from burning to detonation under normal
conditions of carriage. As a minimum requirement they shall not explode in the external fire test.”

Division 1.6: “Extremely insensitive articles which do not have a mass explosion hazard. The articles
contain only extremely insensitive detonating substances and demonstrate a negligible probability of
accidental initiation or propagation. The risk is limited to the explosion of a single article.”

Included in this definition are also explosive or pyrotechnic substances or preparations contained in arti-
cles. In the case of articles containing explosive or pyrotechnic substances or preparations, if the quan-
tity of the substance or preparation contained is known, that quantity shall be considered for the
purposes of this Directive. If the quantity is not known, then, for the purposes of this Directive, the
whole article shall be treated as explosive.’

(iii) in note 3(b)(1), the second indent shall be replaced by the following:

‘— substances and preparations which have a flash point lower than 55 ° C and which remain liquid under
pressure, where particular processing conditions, such as high pressure or high temperature, may create
major-accident hazards;’

(iv) note 3(c)(2) is replaced by the following:

‘2. gases which are flammable in contact with air at ambient temperature and pressure (risk phrase R12,

second indent), which are in a gaseous or supercritical state, and’

(v) note 3(c)3 is replaced by the following:

‘3. flammable and highly flammable liquid substances and preparations maintained at a temperature above

their boiling point.’

(vi) note 4 is replaced by the following:

‘4. In the case of an establishment where no individual substance or preparation is present in a quantity
above or equal to the relevant qualifying quantities, the following rule shall be applied to determine
whether the establishment is covered by the relevant requirements of this Directive.

This Directive shall apply if the sum

q1/QU1 + q2/QU2 + q3/QU3 + q4/QU4 + q5/QU5 +... is greater than or equal to 1,

where qx = the quantity of dangerous substance x (or category of dangerous substances) falling within
Parts 1 or 2 of this Annex,

and QUX = the relevant qualifying quantity for substance or category x from column 3 of Parts 1 or 2.

This Directive shall apply, with the exception of Articles 9, 11 and 13, if the sum

q1/QL1 + q2/QL2 + q3/QL3 + q4/QL4 + q5/QL5 +... is greater than or equal to 1,

where qx = the quantity of dangerous substance x (or category of dangerous substances) falling within
Parts 1 or 2 of this Annex,

and QLX = the relevant qualifying quantity for substance or category x from column 2 of Parts 1 or 2.

This rule shall be used to assess the overall hazards associated with toxicity, flammability, and eco-toxi-
city. It must therefore be applied three times:

(a) for the addition of substances and preparations named in Part 1 and classified as toxic or very toxic,

together with substances and preparations falling into categories 1 or 2;

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(b) for the addition of substances and preparations named in Part 1 and classified as oxidising, explosive,
flammable, highly flammable, or extremely flammable, together with substances and preparations
falling into categories 3, 4, 5, 6, 7a, 7b or 8;

(c) for the addition of substances and preparations named in Part 1 and classified as dangerous for the
environment (R50 (including R50/53) or R51/53), together with substances and preparations falling
into categories 9(i) or 9(ii);

The relevant provisions of this Directive apply if any of the sums obtained by (a), (b) or (c) is greater than
or equal to 1.’

(vii) the following footnotes appear at the end of the notes:

‘(1) OJ 196, 16.8.1967, p.
16.5.2003, p. 36).

l. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122,

(2) OJ L 200, 30.7.1999, p. 1. Directive as amended by Commission Directive 2001/60/EC (OJ L 226,

22.8.2001, p. 5).

(3) OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2003/28/EC (OJ L 90,

8.4.2003, p. 45).’