MT
Dangerous Substances and Preparations Regulations, 2007
Table of Provisions (28)
Statutory Text (28 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,019, 16 ta’ Jannar, 2007
L.N. 10 of 2007
PRODUCT SAFETY ACT
(ACT NO. V OF 2001)
Dangerous Substances and Preparations Regulations, 2007
IN exercise of the powers conferred by article 39 of the Product
Safety Act, the Minister for Competitiveness and Communications has,
on the advice of the Malta Standards Authority, made the following
regulations>-
The title of these regulations is the Dangerous Substances and Citation.
Preparations Regulations, 2007.
Methods for the evaluation of physico-chemical properties of preparations in
accordance with paragraph 8
PART A
Exemptions to test methods of Annex V - Part A to Directive 67/548/EEC
See 2.2.5 of Annex VI to Directive 67/548/EEC.
PART B
Alternative calculation methods
B.1. Non-gaseous preparations
1. Method for the determination of oxidising properties of preparations
containing organic peroxides.
See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.
B.2. Gaseous preparations
1. Method for the determination of oxidising properties
See 9.1.1.2 of Annex VI to Directive 67/548/EEC.
2. Method for the determination of flammability properties
See 9.1.1.1 of Annex VI to Directive 67/548/EEC.
Preparations that fail to comply with the provisions of these General Provision.
regulations shall not be placed on the market by manufacturers or
importers.
Methods for the evaluation of health hazards of preparations in accordance with
paragraph 9
Introduction
An assessment must be made for all the health effects corresponding to the health effects
of substances contained in a preparation. This conventional method described in Parts A
and B of this Schedule is a calculation method which is applicable to all preparations and
which takes into consideration all the health hazards of substances contained in the
preparation. For that purpose the dangerous health effects have been subdivided into
1. acute lethal effects;
2. non-lethal irreversible effects after a single exposure;
3. severe effects after repeated or prolonged exposure;
4. corrosive effects, irritant effects;
5. sensitising effects;
6. carcinogenic effects, mutagenic effects, toxic effects for reproduction.
The health effects of a preparation are to be assessed in accordance with paragraph 9.1(a)
by the conventional method described in parts A and B of this Schedule using individual
concentration limits.
(a) where the dangerous substances listed in Annex I to Directive 67/548/EEC are
assigned concentration limits necessary for the application of the method of
assessment described in part A of this Schedule, these concentration limits must be
used;
(b) where the dangerous substances do not appear in Annex I to Directive 67/548/EEC or
appear there without the concentration limits necessary for the application of the
method of evaluation described in part A of this Schedule, the concentration limits
must be assigned in accordance with the specifications in part B of this Schedule.
The procedure for classification is set out in Part A of this Schedule.
The classification of the substance(s) and the resulting classification of the preparation
are expressed
-
either by a symbol and one or more risk phrases, or
-
by categories (category 1, category 2 or category 3) also assigned risk phrases
when substances and preparations are shown to be carcinogenic, mutagenic or
toxic for reproduction. Therefore it is important to consider, in addition to the
symbol, all the phrases denoting specific risks which are assigned to each
substance under consideration.
The systematic assessment of all the dangerous health effects is expressed by means of
concentration limits, expressed as a weight/weight percentage except for gaseous
preparations where they are expressed as a volume/volume percentage and in conjunction
with the classification of the substance.
Where they are not given in Annex I to Directive 67/548/EEC, the concentration limits to
be taken into account for the application of this conventional method are those set out in
Part B of this Schedule.
PART A
Procedure for evaluation of health hazards
The evaluation proceeds stepwise as follows
1. The following preparations are to be classified as very toxic
1.1. owing to their acute lethal effects and assigned the symbol "T + ", the indication of
danger "very toxic" and the risk phrases R26, R27 or R28;
1.1.1
preparations containing one or more substances classified as very toxic
that produce such effects, in individual concentrations equal to or greater
than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 1 in Part B of this Schedule (Table I and I
A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
1.1.2. preparations containing more than one substance classified as very toxic in lower
individual concentrations than the limits specified under 1.1.1(a) or (b) if
T +
where
P T+ is the percentage by weight or by volume of each very toxic substance in the
preparation,
L T+ is the very toxic limit specified for each very toxic substance, expressed as a
percentage by weight or by volume;
1.2. owing to their non-lethal irreversible effects after a single exposure and assigned the
symbol "T + ", the indication of danger "very toxic" and the risk phrase R39/route of
exposure.
Preparations containing at least one dangerous substance that produces such
effects in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 2 in Part B of this Schedule (Table II and
II A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
2. The following preparations shall be classified as toxic
2.1. owing to their acute lethal effects and assigned the symbol "T", the indication of
danger "toxic" and the risk phrases R23, R24 or R25;
2.1.1
preparations containing one or more substances classified as very toxic or
toxic that produce such effects in individual concentrations equal to or
greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 1 in Part B of this Schedule (Table I and I
A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
2.1.2 preparations containing more than one substance classified as very toxic or
toxic in lower individual concentrations than the limits specified under
2.1.1(a) or (b) if
P T +
P T
T
T
where
P T+ is the percentage by weight or by volume of each very toxic substance in the
preparation,
P T is the percentage by weight or by volume of each toxic substance in the
preparation,
L T is the respective toxic limit specified for each very toxic or toxic substance,
expressed as a percentage by weight or by volume;
2.2. owing to their non-lethal irreversible effects after a single exposure and assigned the
symbol "T", the indication of danger "toxic" and the risk phrase R39/route of
exposure.
Preparations containing at least one dangerous substance classified as very toxic
or toxic that produce such effects in individual concentrations equal to or greater
than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 2 in Part B of this Schedule (Table II and
II A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC
or
appear
in
it
without
concentration
limits;
2.3. owing to their long-term effects and assigned the symbol "T", the indication of
danger "toxic" and the risk phrase R48/route of exposure.
Preparations containing at least one dangerous substance that produces such
effects in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 3 in Part B of this Schedule (Table III and
III A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
3. The following preparations shall be classified as harmful
3.1. owing to their acute lethal effects and assigned the symbol "X n " and the indication of
danger "harmful" and the risk phrases R20, R21 or R22;
3.1.1. preparations containing one or more substances classified as very toxic, toxic or
harmful and that produce such effects in individual concentrations equal to or
greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 1 in Part B of this Schedule (Table I and I
A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
3.1.2 preparations containing more than one substance classified as very toxic, toxic or
harmful in lower individual concentrations than the limits specified under 3.1.1(a)
or (b) if
P T +
P
P T
∑ L
+ Xn ≥ 1
+
L Xn L Xn
Xn
where
P T+ is the percentage by weight or by volume of each very toxic substance in the
preparation,
P T is the percentage by weight or by volume of each toxic substance in the
preparation,
P Xn is the percentage by weight or by volume of each harmful substance in the
preparation,
L Xn is the respective harmful limit specified for each very toxic, toxic or harmful
substance, expressed as percentage by weight or by volume;
3.2. owing to their acute effects to the lungs if swallowed and assigned the symbol "X n ",
and the indication of danger "harmful" and the risk phrase R65.
Preparations classified as harmful according to the criteria specified in paragraph
3.2.3 of Annex VI to Directive 67/548/EEC. In applying the conventional method
according to the above paragraph 3.1 no account shall be taken of the
classification of a substance as R65;
3.3. owing to their non-lethal irreversible effects after a single exposure and assigned the
symbol "X n ", the indication of danger "harmful" and the risk phrase R68/route of
exposure.
Preparations containing at least one dangerous substance classified as very toxic,
toxic or harmful that produces such effects in individual concentrations equal to
or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 2 in Part B of this Schedule (Table II and
II A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
owing to their long-term effects and assigned the symbol "X n ", the indication of
danger "harmful" and the risk phrase R48/route of exposure.
Preparations containing at least one dangerous substance classified as toxic or
harmful that produces such effects in individual concentrations equal to or greater
than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 3 in Part B of this Schedule (Table III and
III A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
4. The following preparations are to be classified as corrosive
and assigned the symbol "C", the indication of danger "corrosive" and the risk
phrase R35;
4.1.1 preparations containing one or more substances classified as corrosive to which is
assigned the phrase R35 in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
4.1.2 preparations containing more than one substance classified as corrosive to which
is assigned phrase R35 in lower individual concentrations than the limits specified
under 4.1.1(a) or (b) if
∑ L
≥ 1
where
P C,R35 is the percentage by weight or by volume of each corrosive substance
which is assigned phrase R35 in the preparation,
L C,R35 is the corrosive limit R35 specified for each corrosive substance to which
is assigned phrase R35, expressed as a percentage by weight or by volume;
and assigned the symbol "C", the indication of danger "corrosive" and the risk
phrase R34;
4.1.1 preparations containing one or more substances classified as corrosive to which is
assigned the phrase R35 or R34 in individual concentrations equal to or greater
than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
4.1.2 preparations containing more than one of the substances classified as corrosive to
which is assigned the phrase R35 or R34 in lower individual concentrations than
the limits specified under 4.2.1(a) or (b) if
∑ L
≥ 1
+
C , R 34
where
P C,R35 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R35 in the preparation,
P C,R34 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R34 in the preparation,
L C,R34 is the respective corrosive limit R34 specified for each corrosive substance
to which is assigned phrase R35 or R34, expressed as a percentage by weight or
by volume.
5. The following preparations are to be classified as irritants
liable to cause serious eye damage and assigned the symbol "X i ", the indication of
danger "irritant" and the risk phrase R41;
5.1.1. preparations containing one or more substances classified as irritant to which is
assigned phrase R41 in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
5.1.2 preparations containing more than one of the substances classified as irritant and
to which is assigned phrase R41, or classified as corrosive and to which is
assigned phrase R35 or R34, in lower individual concentrations than the limits
specified under 5.1.1(a) or (b) if
P Xi , R 41
P C , R 34
∑ L
≥ 1
+
+
L Xi , R 41
L Xi , R 41
Xi , R 41
where
P C,R35 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R35 in the preparation,
P C,R34 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R34 in the preparation,
P Xi,R41 is the percentage by weight or by volume of each irritant substance to
which is assigned phrase R41 in the preparation,
L Xi,R41 is the respective irritant limit R41 specified for each corrosive substance to
which is assigned phrase R35 or R34 or irritant substance to which is assigned
phrase R41, expressed as percentage by weight or by volume;
irritant to eyes and assigned the symbol "X i ", the indication of danger "irritant"
and the risk phrase R36;
5.1.1 preparations containing one or more substances classified as corrosive to which is
assigned phrase R35 or R34 or as irritant and to which is assigned phrase R41 or
R36 in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
5.1.2 preparations containing more than one substance classified as irritant to which is
assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35
or R34, in lower individual concentrations than the limits specified under 5.2.1(a)
or (b) if
P Xi , R 36
P C , R 34
P Xi , R 41
∑ L
≥ 1
+
+
+
L Xi , R 36
L Xi , R 36
L Xi , R 36
Xi , R 36
where
P C,R35 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R35 in the preparation,
P C,R34 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R34 in the preparation,
P Xi,R41 is the percentage by weight or by volume of each irritant substance to
which is assigned phrase R41 in the preparation,
P Xi,R36 is the percentage by weight or by volume of each irritant substance to
which is assigned phrase R36 in the preparation,
L Xi,R36 is the respective irritant limit R36 specified for each corrosive substance to
which is assigned phrase R35 or R34 or irritant substance to which is assigned
phrase R41, or R36 expressed as percentage by weight or by volume;
irritant to skin and assigned the symbol "X i ", the indication of danger "irritant"
and the risk phrase R38;
5.3.1 preparations containing one or more substances classified as irritant and to which
is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or
R34 in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
5.3.2 preparations containing more than one of the substances classified as irritant and
to which is assigned phrase R38, or as corrosive and to which is assigned phrase
R35 or R34 in lower individual concentrations than the limits specified under
5.3.1(a) or (b) if
P Xi , R 38
P C , R 34
∑ L
≥ 1
+
+
L Xi , R 38
L Xi , R 38
Xi , R 38
where
P C,R35 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R35 in the preparation,
P C,R34 is the percentage by weight or by volume of each corrosive substance to
which is assigned phrase R34 in the preparation,
P Xi,R38 is the percentage by weight or by volume of each irritant substance to
which is assigned phrase R38 in the preparation,
L Xi,R38 is the respective irritant limit R38 specified for each corrosive substance to
which is assigned phrase R35 or R34 or irritant substance to which is assigned
phrase R38, expressed as percentage by weight or by volume;
irritant to respiratory system and assigned the symbol "X i ", the indication of
danger "irritant" and the risk phrase R37;
5.4.1 preparations containing one or more substances classified as irritant and to which
is assigned phrase R37 in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 4 in Part B of this Schedule (Table IV and
IV A) where the substance or the substances do not appear in Annex I to
Directive 67/548/EEC or appear in it without concentration limits;
5.4.2 preparations containing more than one substance classified as irritant and to
which is assigned phrase R37 in lower individual concentrations than the limits
specified under 5.4.1(a) or (b) if
P Xi , R 37
∑ L
≥ 1
Xi
,
R
where
P Xi,R37 is the percentage by weight or by volume of each irritant substance to
which is assigned phrase R37 in the preparation,
L Xi,R37 is the irritant limit R37 specified for each irritant substance to which is
assigned phrase R37, expressed as percentage by weight or by volume;
5.4.3. gaseous preparations containing more than one of the substances classified as
irritant to which is assigned phrase R37 or as corrosive and to which is assigned
phrase R35 or R34 in lower individual concentrations than the limits specified
under 5.4.1(a) or (b) if
P Xi , R 37
P C , R 34
∑ L
≥ 1
+
+
L Xi , R 37
L Xi , R 37
Xi , R 37
where
P C,R35 is the percentage by volume of each corrosive substance to which is
assigned phrase R35 in the preparation,
P C,R34 is the percentage by volume of each corrosive substance to which is
assigned phrase R34 in the preparation,
P C,R37 is the percentage by volume of each irritant substance to which is assigned
phrase R37 in the preparation,
L Xi,R37 is the respective irritant limit R37 specified for each gaseous corrosive
substance to which is assigned phrase R35 or R34 or gaseous irritant substance to
which is assigned phrase R37, expressed as percentage by weight or by volume.
6. The following preparations are to be classified as sensitising
by skin contact and assigned the symbol "X i ", the indication of danger "irritant"
and the risk phrase R43.
Preparations containing at least one substance classified as sensitising and to
which is assigned phrase R43 that produces such effects in individual
concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 5 in Part B of this Schedule (Table V and
V A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
by inhalation and assigned the symbol "X n ", the indication of danger "harmful"
and the risk phrase R42.
preparations containing at least one substance classified as sensitising to which is
assigned phrase R42 that produces such effects in individual concentrations equal
to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 5 in Part B of this Schedule (Table V and
V A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
7. The following preparations are to be classified as carcinogenic
those of category 1 or 2 which are assigned the symbol "T" and the phrase R45 or
R49.
preparations containing at least one substance producing such effects, classified as
carcinogenic and to which is assigned phrase R45 or R49 which denotes
carcinogenic substances in category 1 and category 2, in individual concentrations
equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
those of category 3 which are assigned the symbol "X n " and the phrase R40.
preparations containing at least one substance producing such effects classified as
carcinogenic and to which is assigned phrase R40 which denotes carcinogenic
substances in category 3, in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
8. The following preparations are to be classified as mutagenic
those of category 1 or 2 which are assigned the symbol "T" and the phrase R46.
preparations containing at least one substance producing such effects, classified as
mutagenic and to which is assigned phrase R46 which denotes mutagenic
substances in category 1 and category 2, in individual concentrations equal to or
greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
those of category 3 which are assigned the symbol "X n " and the phrase R68.
preparations containing at least one substance, producing such effects, classified
as mutagenic and to which is assigned phrase R68 which denotes mutagenic
substances in category 3, in individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
9. The following preparations are to be classified as toxic for reproduction
those of category 1 or 2 which are assigned the symbol "T" and the phrase R60
(fertility).
preparations containing at least one substance producing such effects, classified as
toxic for reproduction and to which is assigned phrase R60 which denotes
substances toxic for reproduction of category 1 and category 2, in individual
concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
those of category 3 which are assigned the symbol "X n " and the phrase R62
(fertility).
preparations containing at least one substance producing such effects, classified as
toxic for reproduction and to which is assigned phrase R62 which denotes
substances toxic for reproduction of category 3, in individual concentrations equal
to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI
and VI A) where the substance or substances do not appear in Annex I to
Directive 67/548/EEC or appear in it without concentration limits;
those of category 1 or 2 which are assigned the symbol "T" and the phrase R61
(development).
preparations containing at least one substance producing such effects, classified as
toxic for reproduction and to which is assigned phrase R61 which denotes
substances toxic for reproduction of category 1 and category 2, in individual
concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits;
those of category 3 which are assigned the symbol "X n " and the phrase R63
(development).
preparations containing at least one substance producing such effects, classified as
toxic for reproduction and to which is assigned phrase R63 which denotes
substances toxic for reproduction of category 3, in individual concentrations equal
to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table VI and
VI A) where the substance or substances do not appear in Annex I to Directive
67/548/EEC or appear in it without concentration limits.
PART B
Concentration limits to be used in evaluation of health hazards
For each health effect, the first table (Tables I to VI) sets out the concentration limits
(expressed as a weight/weight percentage) to be used for non-gaseous preparations and
the second table (Tables I A to VI A) sets out the concentration limits (expressed as a
volume/volume percentage) to be used for gaseous preparations. These concentration
limits are used in the absence of specific concentration limits for the substance under
consideration in Annex I to Directive 67/548/EEC.
1. Acute lethal effects
1.1
Non-gaseous preparations
The concentration limits fixed in Table I, expressed as a weight/weight
percentage, determine the classification of the preparation in relation to the
individual concentration of the substance(s) present whose classification is also
shown.
Table I
Classification of
Classification of the preparation
+
the substance
T
T
X n
T + with R26, R27,
concentration ≥ 7
1 %
0.1 %
≤ concentration < 7 ≤ concentration < 1
%
%
%
concentration ≥ 25
T with R23, R24,
3 %
≤ concentration ≤
%
25 %
concentration ≥ 25
X n with R20, R21,
%
The R phrases denoting risk are to be assigned to the preparation in accordance
with the following criteria
-
the label shall include one or more of the abovementioned R phrases
according to the classification used,
-
in general, the R phrases selected should be those applicable to the
substance(s) present in the concentration which gives rise to the most severe
classification.
1.2
Gaseous preparations
The concentration limits expressed as a volume/volume percentage in Table I A
below determine the classification of the gaseous preparations in relation to the
individual concentration of the gas(es) present whose classification is also shown.
Table I A
Classification of
Classification of the gaseous preparation
T +
the substance
T
X n
(gas)
T + with R26, R27,
concentration ≥ 1
0.2 %
0.02 %
≤ concentration < 1
≤ concentration <
%
%
0.2 %
concentration ≥ 5
T with R23, R24,
0.5 %
≤ concentration ≤ 5
%
%
concentration ≥ 5
X n with R20, R21,
%
The R phrases denoting risk shall be assigned to the preparation in accordance
with the following criteria
-
the label shall include one or more of the abovementioned R phrases
according to the classification used,
-
in general, the R phrases selected should be those applicable to the
substance(s) present in the concentration which gives rise to the most severe
classification.
2. Non-lethal irreversible effects after a single exposure
Non-gaseous preparations
For substances that produce non-lethal irreversible effects after a single exposure
(R39/route of exposure, R68/route of exposure), the individual concentration
limits specified in Table II, expressed as a weight/weight percentage, determine,
when appropriate, the classification of the preparation.
Table II
Classification of
Classification of the preparation
T +
the substance
T
X n
concentration ≥ 10
T with R39/route
1 %
0.1 %
≤ concentration < ≤ concentration < 1
of exposure
%
R39 (*) obligatory
10 %
%
R39 (*) obligatory R68 (*) obligatory
concentration ≥ 10
T with R39/route of
1 %
≤ concentration ≤
exposure
%
R39 (*) obligatory
10 %
R68 (*) obligatory
concentration ≥ 10
X n with R68/route
of exposure
%
R68 (*) obligatory
(*) In order to indicate the route of administration/exposure (route of exposure) the
combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide
(Annex VI to Directive 67/548/EEC) are to be used.
Gaseous preparations
For gases that produce non-lethal irreversible effects after a single exposure
(R39/route of exposure, R68/route of exposure), the individual concentration
limits specified in Table II A, expressed as a volume/volume percentage,
determine, when appropriate, the classification of the preparation.
Table II A
Classification of
Classification of the gaseous preparation
+
the substance (gas)
T
T
X n
T + with R39/route
concentration ≥ 1
0.2 %
0.02 %
≤ concentration < 1 ≤ concentration <
of exposure
%
R39 (*) obligatory
%
0.2 %
R39 (*) obligatory R68 (*) obligatory
concentration ≥ 5
T with R39/route of
0.5 %
exposure
%
≤ concentration ≤ 5
R39 (*) obligatory
%
R68 (*) obligatory
concentration ≥ 5
X n with R68/route
of exposure
%
R68 (*) obligatory
(*) In order to indicate the route of administration/exposure (route of exposure) the
combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide
(Annex VI to Directive 67/548/EEC) are to be used.
3. Severe effects after repeated or prolonged exposure
Non-gaseous preparations
For substances that produce severe effects after repeated or prolonged exposure
(R 48/route of exposure), the individual concentration limits specified in Table
III, expressed as a weight/weight percentage, determine, when appropriate, the
classification of the preparation.
Table III
Classification of the substance
Classification of the preparation
T
X n
concentration ≥ 10 %
1 % ≤ concentration < 10 %
T with R48/route of exposure
R48 (*) obligatory
R48 (*) obligatory
concentration ≥ 10 %
X n with R48/route of exposure
R48 (*) obligatory
(*) In order to indicate the route of administration/exposure (route of exposure) the
combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide
(Annex VI to Directive 67/548/EEC) are to be used.
Gaseous preparations
For gases that produce severe effects after repeated or prolonged exposure
(R48/route of exposure), the individual concentration limits specified in Table III
A below, expressed as a volume/volume percentage, determine, when appropriate,
the classification of the preparation.
Table III A
Classification of the substance
Classification of the preparation
T
X n
concentration ≥ 5 %
0.5 % ≤ concentration < 5 %
T with R48/route of exposure
R48 (*) obligatory
R48 (*) obligatory
concentration ≥ 5 %
X n with R48/route of exposure
R48 (*) obligatory
(*) In order to indicate the route of administration/exposure (route of exposure) the
combined R phrases listed under points 3.2.1, 3.2.2 and 3.2.3 of the labelling guide
(Annex VI to Directive 67/548/EEC) are to be used.
4. Corrosive and irritant effects including serious damage to the eye
Non-gaseous preparations
For substances that produce corrosive effects (R34, R35) or irritant effects (R36,
R37, R38, R41), the individual concentration limits specified in Table IV,
expressed as a weight/weight percentage, determine, when appropriate, the
classification of the preparation.
Table IV
Classification
Classification of the preparation
of the
C with R35
C with R34
X i with R41
X i with R36,
substance
R37, R38
5% ≤
1 % ≤
C with R35
concentration
5 % (*)
≥ 10 %
concentration
concentration
R35 obligatory
< 10 %
< 5 %
R34 obligatory
R36/38
obligatory
5 % ≤
C with R34
concentration
10 % (*)
≥ 10 %
concentration
R34 obligatory
< 10 %
R36/38
obligatory
5 % ≤
X i with R41
concentration
≥ 10 %
concentration
R41 obligatory
< 10 %
R36 obligatory
X i with R36,
concentration
≥ 20 %
R37, R38
R36, R37, R38
are obligatory
in the light of
the
concentration
present if they
apply to the
substances
under
consideration
(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive
substances assigned risk phrases R35 or R34 must also be considered as being
assigned phrase R41. Consequently, if the preparation contains corrosive substances
with R35 or R34 below the concentration limits for a classification of the preparation
as corrosive, such substances can contribute to a classification of the preparation as
irritant with R41 or irritant with R36.
NB: Simple application of the conventional method to preparations containing
substances classified as corrosive or irritant may result in under-classification or over-
classification of the hazard, if other relevant factors (e.g. pH of the preparation) are
not taken into account. Therefore, in classifying for corrosivity, consider the advice
given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and
third indents of regulation 7.3 of these Regulations.
4.2.
Gaseous preparations
For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the
individual concentration limits specified in Table IV A below, expressed as a
volume/volume percentage determine, when appropriate, the classification of the
preparation.
Table IV A
Classification
Classification of the gaseous preparation
of the
C with R35
C with R34
X i with R41
X i with R36,
substance
R37, R38
(gas)
0.2 % ≤
0.02 % ≤
C with R35
concentration
0.2 % (*)
≥ 1 %
concentration
concentration
R35 obligatory
< 1 %
< 0.2 %
R34 obligatory
R36/38
obligatory
0.5 % ≤
C with R34
concentration
5 % (*)
≥ 5 %
concentration
R34 obligatory
< 5 %
R36/38
obligatory
0.5 % ≤
X i with R41
concentration
≥ 5 %
concentration
R41 obligatory
< 5 %
R36 obligatory
X i with R36,
concentration
≥ 5 %
R37, R38
R36, R37, R38
obligatory as
appropriate
(*) According to the labelling guide (Annex VI to Directive 67/548/EEC), corrosive
substances assigned risk phrases R35 or R34 must also be considered as being
assigned phrase R41. Consequently, if the preparation contains corrosive substances
with R35 or R34 below the concentration limits for a classification of the preparation
as corrosive, such substances can contribute to a classification of the preparation as
irritant with R41 or irritant with R36.
NB: Simple application of the conventional method to preparations containing
substances classified as corrosive or irritant may result in under-classification or over-
classification of the hazard, if other relevant factors (e.g. pH of the preparation) are
not taken into account. Therefore, in classifying for corrosivity, consider the advice
given in paragraph 3.2.5 of Annex VI to Directive 67/548/EEC and in the second and
third indents of regulation 7.3 of these Regulations.
5. Sensitising effects
Non-gaseous preparations
preparations that produce such effects are classified as sensitising and assigned
-
the symbol X n and phrase R42 if this effect can be produced by inhalation,
-
the symbol X i and phrase R43 if this effect can be produced through contact
with the skin.
The individual concentration limits specified in Table V, expressed as a
weight/weight percentage, determine, when appropriate, the classification of the
preparation.
Table V
Classification of the substance
Classification of the preparation
Sensitising with R42
Sensitising with R43
concentration ≥ 1 %
Sensitising with R42
R42 obligatory
concentration ≥ 1 %
Sensitising with R43
R43 obligatory
Gaseous preparations
Gaseous preparations that produce such effects are classified as sensitising and
assigned
-
the symbol X n and phrase R42 if this effect can be produced by inhalation,
-
the symbol X i and phrase R43 if this effect can be produced through contact
with the skin.
The individual concentration limits specified in Table V A below, expressed as a
volume/volume percentage, determine, when appropriate, the classification of the
preparation.
Table V A
Classification of the substance
Classification of the gaseous preparation
(gas)
Sensitising with R42
Sensitising with R43
concentration ≥ 0.2 %
Sensitising with R42
R42 obligatory
concentration ≥ 0.2 %
Sensitising with R43
R43 obligatory
6. Carcinogenic/mutagenic/toxic effects for reproduction
Non-gaseous preparations
For substances which produce such effects, the concentration limits laid down in
Table VI, expressed as a weight/weight percentage, shall determine, where
appropriate, the classification of the preparation. The following symbol and risk
phrases are assigned
Carcinogenic categories 1 and 2
T; R45 or R49
Carcinogenic category 3
X n ; R40
Mutagenic categories 1 and 2
T; R46
Mutagenic category 3
X n ; R68
Toxic for reproduction fertility categories 1 and 2
T; R60
Toxic for reproduction development categories 1 and 2
T; R61
Toxic for reproduction fertility category 3
X n ; R62
Toxic for reproduction development category 3
X n ; R63
Table VI
Classification of the
Classification of the preparation
substance
Categories 1 and 2
Category 3
concentration ≥ 0.1 %
carcinogenic substances of
category 1 or 2 with R45
carcinogenic
or R49
R45, R49 obligatory as
appropriate
concentration ≥ 1 %
carcinogenic substances of
category 3 with R40
carcinogenic
R40 obligatory (unless
already assigned R45(*))
concentration ≥ 0.1 %
mutagenic substances of
category 1 or 2 with R46
mutagenic
R46 obligatory
concentration ≥ 1 %
mutagenic substances of
category 3 with R68
mutagenic
R68 obligatory (unless
already assigned R46)
concentration ≥ 0.5 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
1 or 2 with R60 (fertility)
(fertility)
R60 obligatory
concentration ≥ 5 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
3 with R62 (fertility)
(fertility) R62 obligatory
(unless already assigned
R60)
concentration ≥ 0.5 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
1 or 2 with R61
(development)
(development)
R61 obligatory
concentration ≥ 5 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
3 with R63 (development)
(development) R63
obligatory (unless already
assigned R61)
(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be
kept, because R40 does not distinguish between the exposure routes, whereas R49 is
only assigned for the inhalation route.
Gaseous preparations
For gases which produce such effects, the concentration limits laid down in Table
VI A, expressed as a volume/volume percentage, shall determine, where
appropriate, the classification of the preparation. The following symbol and risk
phrases are assigned
Carcinogenic categories 1 and 2
T; R45 or R49
Carcinogenic category 3
X n ; R40
Mutagenic categories 1 and 2
T; R46
Mutagenic category 3
X n ; R68
Toxic for reproduction fertility categories 1 and 2
T; R60
Toxic for reproduction development categories 1 and 2
T; R61
Toxic for reproduction fertility category 3
X n ; R62
Toxic for reproduction development category 3
X n ; R63
Table VI A
Classification of the
Classification of the preparation
substance
Categories 1 and 2
Category 3
concentration ≥ 0.1 %
carcinogenic substances of
category 1 or 2 with R45
carcinogenic
or R49
R45, R49 obligatory as
appropriate
concentration ≥ 1 %
carcinogenic substances of
category 3 with R40
carcinogenic
R40 obligatory (unless
already assigned R45(*))
concentration ≥ 0.1 %
mutagenic substances of
category 1 or 2 with R46
mutagenic
R46 obligatory
concentration ≥ 1 %
mutagenic substances of
category 3 with R68
mutagenic
R68 obligatory (unless
already assigned R46)
concentration ≥ 0.2 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
1 or 2 with R60 (fertility)
(fertility)
R60 obligatory
Classification of the
Classification of the preparation
substance
Categories 1 and 2
Category 3
concentration ≥ 1 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
3 with R62 (fertility)
(fertility)
R62 obligatory (unless
already assigned R60)
concentration ≥ 0.2 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
1 or 2 with R61
(development)
(development)
R61 obligatory
concentration ≥ 1 %
substances ‘toxic for
reproduction’ of category
toxic for reproduction
3 with R63 (development)
(development)
R63 obligatory (unless
already assigned R61)
(*) In cases where the preparation is assigned R49 and R40, both R phrases shall be
kept, because R40 does not distinguish between the exposure routes, whereas R49 is
only assigned for the inhalation route.
These regulations implement the provisions of Commission Scope.
Directive 1999#45#EC of the 31 st May, 1991 as amended by Commission
Directive 2001#60#EC of the 7 th August, 2001.
Applicability.
These regulations shall apply to>
Methods for the evaluation of the environmental hazards of preparations in
accordance with paragraph 10
Introduction
The systematic assessment of all the dangerous properties for the environment is
expressed by means of concentration limits, expressed as a weight/weight percentage
except for gaseous preparations where they are expressed as a volume/volume percentage
and in conjunction with the classification of a substance.
Part A gives the calculation procedure according to paragraph 10.1(a) and gives the R
phrases to be assigned to the classification of the preparation.
Part B gives the concentration limits to be used when applying the conventional method
and relevant symbols and R phrases for classification.
In accordance with paragraph 10.1 (a) the environmental hazards of a preparation shall be
assessed by the conventional method described in parts A and B of this Schedule, using
individual concentration limits.
(a) Where the dangerous substances listed in Annex 1 to Directive 67/548/EEC are
assigned concentration limits necessary for the application of the method of
assessment described in Part A of this Schedule, these concentration limits must be
used.
(b) Where the dangerous substances do not appear in Annex I to Directive 67/548/EEC
or appear there without the concentration limits necessary for the application of the
method of evaluation described in Part A of this Schedule, the concentration limits
shall be assigned in accordance with the specification in Part B of this Schedule.
Part C gives the test methods for the evaluation of the hazards for the aquatic
environment.
PART A
Procedure for the evaluation of environmental hazards
(a)
Aquatic environment
I.
Conventional method for the evaluation of hazards to the aquatic environment
The conventional method for the evaluation of hazards to the aquatic environment
takes into account all the hazards that a preparation may entail for this medium
according to the following specifications.
The following preparations are to be classified as dangerous for the
environment
1. and assigned the symbol "N", the indication of danger "dangerous for the
environment" and the risk phrases R50 and R53 (R50-53)
preparations containing one or more substances classified as dangerous to the
environment and to which is assigned phrases R50-53 in individual concentrations
equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 1) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one substance classified as dangerous for the
environment and to which is assigned phrases R50-53 in lower individual
concentrations than the limits specified under I.1.1(a) or (b) if
∑ L
≥ 1
where
P N,R50-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R50-53 in the preparation,
L N,R50-53 is the limit R50-53 for each substance dangerous for the environment to
which is assigned the phrases R50-53, expressed as percentage by weight
2. and assigned the symbol "N", the indication of danger "dangerous for the
environment" and the risk phrases R51 and R53 (R51-53) unless the preparation
is already classified according to I.1 above;
preparations containing one or more than one substance classified as dangerous to
the environment and to which is assigned phrases R50-53 or R51-53 in individual
concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 1) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one of the substances classified as dangerous
for the environment and to which is assigned phrases R50-53 or R51-53 in lower
individual concentrations than the limits specified under I.2. (a) or (b) if
∑ L
≥ 1
+
N , R 51 − 53
where
P N,R50-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R50-53 in the preparation,
P N,R51-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R51-53 in the preparation,
L N,R51-53 is the respective limit R51-53 for each substance dangerous for the
environment to which is assigned phrases R50-53 or R51-53, expressed as
percentage by weight
3. and assigned the risk phrases R52 and R53 (R52-53) unless the preparation is
already classified according to I.1 or I.2 above;
preparations containing one or more than one substance classified as dangerous to
the environment and to which is assigned phrases R50-53 or R51-53 or R52-53 in
individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 1) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one of the substances classified as dangerous
for the environment and to which is assigned phrases R51-53 or R50-53 or R52-
53 in lower individual concentrations than the limits specified under I.3.1(a) or (b)
if
P R 52 − 53
P N , R 51 − 53
∑ L
≥ 1
+
+
L R 52 − 53
L R 52 − 53
R 52 − 53
where
P N,R50-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R50-53 in the preparation,
P N,R51-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R51-53 in the preparation,
P R52-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R52-53 in the preparation,
L R52-53 is the respective limit R52-53 for each substance dangerous for the
environment to which is assigned phrases R50-53 or R51-53 or R52-53, expressed
as percentage by weight;
4. and assigned the symbol "N", the indication of danger "dangerous for the
environment" and the risk phrase R50 unless the preparation is already classified
according to I.1 above
preparations containing one or more than one substance classified as dangerous to
the environment and to which is assigned phrase R50 in individual concentrations
equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 2) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one substance classified as dangerous for the
environment and to which is assigned phrase R50 in lower individual
concentrations than the limits specified under I.4.1(a) or (b) if
∑ L
≥ 1
N
,
R
where
P N,R50 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrase R50 in the preparation,
L N,R50 is the limit R50 for each substance dangerous for the environment to which
is assigned phrase R50, expressed as percentage by weight.
preparations containing one or more than one of the substances classified as
dangerous for the environment and to which is assigned phrase R50 not meeting
the criteria under I.4.1 or I.4.2 and containing one or more than one substance
classified as dangerous for the environment and to which is assigned phrases R50-
53 if
∑ L
≥ 1
+
N , R 50
where
P N,R50 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrase R50 in the preparation,
P N,R50-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrases R50-53 in the preparation,
L N,R50 is the perspective limit R50 for each substance dangerous for the
environment to which is assigned phrases R50 or R50-53, expressed as percentage
by weight;
5. and assigned the risk phrase R52 unless the preparation is already classified
according to I.1, I.2, I.3, or I.4 above
preparations containing one or more than one substance classified as dangerous to
the environment and to which is assigned phrase R52 in individual concentrations
equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 3) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one substance classified as dangerous for the
environment and to which is assigned phrase R52 in lower individual
concentrations than the limits specified under I.5.1 (a) or (b) if
P R 52
∑ L
≥ 1
R 52
where
P R52 is the percentage by weight of each substance dangerous for the environment
to which is assigned phrase R52 in the preparation,
L R52 is the limit R52 for each substance dangerous for the environment to which is
assigned phrase R52, expressed as percentage by weight;
6. and assigned the risk phrase R53 unless the preparation is already classified
according to I.1, I.2, or I.3 above
preparations containing one or more than one substance classified as dangerous to
the environment and to which is assigned phrase R53 in individual concentrations
equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 4) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
preparations containing more than one substance classified as dangerous for the
environment and to which is assigned phrase R53 in lower individual
concentrations than the limits specified under I.6.1(a) or (b) if
P R 53
∑ L
≥ 1
R 53
where
P R53 is the percentage by weight of each substance dangerous for the environment
to which is assigned phrase R53 in the preparation,
L R53 is the limit R53 for each substance dangerous for the environment to which is
assigned phrase R53, expressed as percentage by weight;
preparations containing one or more than one of the substances classified as
dangerous for the environment and to which is assigned phrase R53 not meeting
the criteria under I.6.2 and containing one or more than one substance classified
as dangerous for the environment and to which is assigned phrases R50-53 or
R51-53 or R52-53 if
P R 53
P R 52 − 53
P N , R 50 − 53
P N , R 51 − 53
∑ L
≥ 1
+
+
+
L R 53
L R 53
L R 53
where
P R53 is the percentage by weight of each substance dangerous for the environment
to which is assigned phrase R53 in the preparation,
P N,R50-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrase R50-53 in the preparation,
P N,R51-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrase R51-53 in the preparation,
P R52-53 is the percentage by weight of each substance dangerous for the
environment to which is assigned phrase R52-53 in the preparation,
L R53 is the respective limit R53 for each substance dangerous for the environment
to which is assigned phrase R53 or R50-53 or R51-53 or R52-53, expressed as
percentage by weight.
(b)
Non-aquatic environment
(1)
OZONE LAYER
Conventional method for the evaluation of preparations dangerous for the ozone
layer
The following preparations are to classified as dangerous for the environment
1. and assigned the symbol "N", the indication of danger "dangerous for the
environment" and the risk phrase R59;
preparations containing one or more substances classified as dangerous to the
environment and to which is assigned the symbol "N" and the risk phrase R59 in
individual concentrations equal to or greater than
(a) either the concentration specified in Annex I to Directive 67/548/EEC for the
substance or substances under consideration, or
(b) the concentration specified in Part B of this Schedule (Table 5) where the
substance or substances do not appear in Annex I to Directive 67/548/EEC or
appear in it without concentration limits;
(2)
TERRESTRIAL ENVIRONMENT
Evaluation of preparations dangerous for the terrestrial environment
Classification of preparations using the risk phrases below will follow after the
detailed criteria for use of the phrases have been incorporated in Annex VI to
Directive 67/548/EEC.
Toxic to flora
Toxic to fauna
Toxic to soil organisms
Toxic to bees
May cause long-term adverse effects in the environment.
PART B
Concentration limits to be used for the evaluation of environmental hazards
For the aquatic environment
The concentration limits fixed in the following tables, expressed as a
weight/weight percentage, determine the classification of the preparation in
relation to the individual concentration of the substance(s) present whose
classification is also shown.
Table 1a
Acute aquatic toxicity and long-term adverse effects
Classification of the
Classification of the preparation
substance
N,R50-53
N,R51-53
R52-53
N,R50-53
See Table 1b
See Table 1b
See Table 1b
C n ≥ 25 %
2.5 % ≤ C n < 25 %
N,R51-53
C n ≥ 25 %
R52-53
Preparations containing a substance classified with N, R50-53, the concentration limits
and the resulting classification given in table 1b are applicable
Table 1b
Acute aquatic toxicity and long-term adverse effects of substances very toxic to the
aquatic environment
LC 50 or EC 50 value (“L(E)C 50 ”)
Classification of the preparation
of substance classified as N,
N, R50-53
N, R51-53
R52-53
R50-53 (mg/l)
0.1 < L(E)C 50 ≤ 1
C n ≥ 25 %
2.5 % ≤ C n < 25 %
0.25 % ≤ C n < 2.5 %
0.01 < L(E)C 50 ≤ 0.1
C n ≥ 2.5 %
0.25 % ≤ C n < 2.5 %
0.025 % ≤ C n < 0.25 %
0.001 < L(E)C 50 ≤ 0.01
C n ≥ 0.25 %
0.025 % ≤ C n < 0.25 %
0.0025 % ≤ C n < 0.025 %
0.0001 < L(E)C 50 ≤ 0.001
C n ≥ 0.025 %
0.0025 % ≤ C n < 0.025 %
0.00025 % ≤ C n <
0.0025 %
0.00001 < L(E)C 50 ≤ 0.0001
C n ≥ 0.0025 %
0.00025 % ≤ C n < 0.0025 %
0.000025 % ≤ C n <
0.00025 %
For preparations containing substances with a lower LC 50 or EC 50 value than 0.00001 mg/l, the
corresponding concentration limits are calculated accordingly ( in factor 10 intervals).
Table 2
Acute aquatic toxicity
LC 50 or EC 50 value (“L(E)C 50 ”) of substance
Classification of the preparation
classified as N, R50-53 (mg/l)
N,R50
0.1 < L(E)C 50 ≤ 1
C n ≥ 25 %
0.01 < L(E)C 50 ≤ 0.1
C n ≥ 2.5 %
0.001 < L(E)C 50 ≤ 0.01
C n ≥ 0.25 %
0.0001 < L(E)C 50 ≤ 0.001
C n ≥ 0.025 %
0.00001 < L(E)C 50 ≤ 0.0001
C n ≥ 0.0025 %
For preparations containing substances with a lower LC 50 or EC 50 value than 0.00001
mg/l, the corresponding concentration limits are calculated accordingly ( in factor 10
intervals).
Table 3
Aquatic toxicity
Classification of the substance
Classification of the preparation R52
C n ≥ 25 %
Table 4
Long-term adverse effects
Classification of the substance
Classification of the preparation R53
C n ≥ 25 %
C n ≥ 25 %
N, R50-53
C n ≥ 25 %
N, R51-53
C n ≥ 25 %
R52-53
II.
For the non-aquatic environment
The concentration limits fixed in the following tables, expressed as weight/weight
percentage or, for gaseous preparations as a volume/volume percentage,
determine the classification of the preparation in relation to the individual
concentration of the substance(s) present whose classification is also shown.
Table 5
Dangerous for the ozone layer
Classification of the substance
Classification of the preparation
N, R59
C n ≥ 0.1 %
N with R59
PART C
Test methods for the evaluation of the hazards for the aquatic environment
Normally, the classification of a preparation is made on the basis of the conventional
method. However, for the determination of the acute aquatic toxicity, there may be cases
for which it is appropriate to carry out tests on the preparation.
The result of these tests on the preparation may only modify the classification concerning
acute aquatic toxicity which would have been obtained by the application of the
conventional method.
If such tests are chosen by the person responsible for the placing on the market, it must be
ensured that the quality criteria of the test methods in Part C of Annex V to Directive
67/548/EEC have been complied with.
Furthermore, the tests are to be carried out on all three species in conformity with the
criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the
highest hazard classification relating to acute aquatic toxicity has been assigned to the
preparation after testing on one of the species or a test result was already available before
Directive 1999/45/EC entered into force.
1.
– the classification, packaging and labelling of dangerous
preparations, and to
– those preparations which may present hazards, whether
or not they are classified as dangerous within the meaning of those
regulations, when such preparations are placed on the market.
4.2. These regulation shall apply to preparations which>
– contain at least one dangerous substance within the
meaning of regulation 5, and
– are considered dangerous within the meaning of
regulations 8, 9 or 10.
4.3. The specific provisions set out>
–
in regulation 11 and defined in the Fourth Schedule,
–
in regulation 12 and defined in the Fifth Schedule, and
–
in regulation 16
shall also apply to preparations which are not considered dangerous
within the meaning of regulations 8, 9 or 10 but may nevertheless present
a specific hazard.
4.4.1 Without prejudice to other provisions implementing the
requirements of the Plant Protection Products Regulations, 2004, the
regulations on classification, packaging, labelling and safety datasheets
of these Regulations shall apply to plant protection products.
4.4.2 Without prejudice to other provisions implementing the
requirements of the Biocides Regulations, 2004, the regulations on
classification, packaging, labelling and safety datasheets of these
Regulations shall apply to Biocide products.
4.5. These regulations shall not apply to the following
preparations in the finished state, intended for the final user>
(a) medicinal products for human or veterinary use, as
defined in the Act<
(b) cosmetic products as defined in the Cosmetic Products
Regulations, 2004<
(c) mixtures of substances which, in the form of waste, are
covered by provisions implementing the requirements of the Waste
Management (Permit and Control) Regulations, 2001<
(d) foodstuffs<
(e)
animal feedingstuffs<
(f) preparations containing radioactive substances as defined
by the Nuclear Safety and Radiation Protection Regulations, 2002<
(g) medical devices which are invasive or used in direct
physical contact with the human body in so far as other measures
lay down provisions for the classification and labelling of dangerous
substances and preparations which ensure the same level of
information provision and protection as these Regulations.
4.6. These Regulations shall not apply to>
– the carriage of dangerous preparations by rail, road, inland
waterway, sea or air,
– preparations in transit which are under customs
supervision, provided they do not undergo any treatment or
processing.
Special provisions for containers containing preparations offered or sold to the
general public
PART A
Containers to be fitted with child-resistant fastenings
1. Containers of whatever capacity, containing preparations offered or sold to the
general public and labelled as very toxic, toxic or corrosive in accordance with
paragraph 11 and under the conditions laid down in paragraph 7 of these Regulations,
are to fitted with child-resistant fastenings.
2. Containers of whatever capacity containing preparations presenting an aspiration
hazard (X n , R65) and classified and labelled according to paragraph 3.2.3 of Annex
VI to Directive 67/548/EEC with the exception of preparations placed on the market
in the form of aerosols or in a container fitted with a sealed spray attachment.
3. Containers of whatever capacity, having at least one of the substances mentioned
below in a concentration equal to or greater than the maximum individual
concentration specified.
No
Identification of the substance
Concentration
limit
CAS Reg No
Name
Einecs No
≥ 3 %
67-56-1
Methanol
2006596
≥ 1 %
75-09-2
Dichloromethane
2008389
which are offered or sold to the general public are to be fitted with child-resistant
fastenings.
PART B
Containers to be fitted with a tactile warning of danger
Containers of whatever capacity, containing preparations offered or sold to the general
public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or
highly flammable in accordance with paragraph 11 and under the conditions laid down in
paragraphs 6 and 7 of these Regulations, are to carry a tactile warning of danger.
This provision does not apply to aerosols classified and labelled only as extremely
flammable or highly flammable.
1. In these Regulations, the following definitions shall apply, Definitions.
unless the context otherwise requires>
(a) “substances” means chemical elements and their
compounds in the natural state or obtained by any production
process, including any additive necessary to preserve the stability
of the products and any impurity deriving from the process used,
but excluding any solvent which may be separated without affecting
the stability of the substance or changing its composition<
(b) “preparations” means mixtures or solutions composed
of two or more substances<
(c) “polymer” means a substance consisting of molecules
characterised by the sequence of one or more types of monomer
units and comprising a simple weight majority of molecules
containing at least three monomer units which are covalently bound
to at least one other monomer unit or other reactant and consists of
less than a simple weight majority of molecules of the same
molecular weight. Such molecules must be distributed over a range
of molecular weights wherein differences in the number of
monomer units. In the context of this definition a “monomer unit”
means the reacted form of a monomer in a polymer<
(d) “placing on the market” means making available to third
parties. Importation into customs territory shall be deemed to be
placing on the market for the purposes of these regulations<
(e) “scientific research and development” means scientific
experimentation, analysis or chemical research carried out under
controlled conditions< it includes the determination of intrinsic
properties, performance and efficacy as well as scientific
investigation related to product development<
(f) “process-orientated research and development” means
the further development of a substance in the course of which pilot
plant or production trials are used to test the fields of application
of the substance<
(g) “Einecs” means the European Inventory of Existing
Commercial Chemical Substances. This inventory contain the
definitive list of all chemical substances deemed to on the market
within the European Community on 18 September 1981.
5.2. The following are “dangerous” within the meaning of these
regulations>
(a)
explosive substances and preparations>
– solid, liquid, pasty or gelatinous substances and
preparations which may also react exothermically without
atmospheric oxygen thereby quickly evolving gases, and
which, under defined test conditions, detonate, quickly
deflagrate or upon heating explode when partially confined<
(b) oxidising substances and preparations>
– substances and preparations which give rise to a
highly exothermic reaction in contact with other substances,
particularly flammable substances<
(c)
extremely flammable substances and preparations>
– liquid substances and preparations having an
extremely low flash-point and a low boiling-point and gaseous
substances and preparations which are flammable in contact
with air at ambient temperature and pressure<
(d) highly flammable substances and preparations>
– substances and preparations which may become hot
and finally catch fire in contact with air at ambient temperature
without any application of energy, or
– solid substances and preparations which may readily
catch fire after brief contact with a source of ignition and
which continue to burn or to be consumed after removal of
the source of ignition, or
– liquid substances and preparations having a very low
flash-point, or
– substances and preparations which, in contact with
water or damp air, evolve extremely flammable gases in
dangerous quantities<
(e)
flammable substances and preparations>
– liquid substances and preparations having a low
flash-point<
(f)
very toxic substances and preparations>
– substances and preparations which in very low
quantities cause death or acute or chronic damage to health
when inhaled, swallowed or absorbed via the skin<
(g) toxic substances and preparations>
– substances and preparations which in low quantities
cause death or acute or chronic damage to health when inhaled,
swallowed or absorbed via the skin<
(h) harmful substances and preparations>
– substances and preparations which may cause death
or acute or chronic damage to health when inhaled, swallowed
or absorbed via the skin<
(i) corrosive substances and preparations>
– substances and preparations which may, on contact
with living tissues, destroy them<
(j) irritant substances and preparations>
– non-corrosive substances and preparations which,
through immediate, prolonged or repeated contact with skin
or mucous membrane, may cause inflammation<
(k) sensitising substances and preparations>
– substances and preparations which, if they are inhaled
or if they penetrate the skin, are capable of eliciting a reaction
of hypersensitisation such that on further exposure to the
substance or preparation, characteristic adverse effects are
produced<
(l) carcinogenic substances and preparations>
– substances or preparations which, if they are inhaled
or ingested or if they penetrate the skin, may induce cancer
or increase its incidence<
(m) mutagenic substances and preparations>
– substances and preparations which, if they are inhaled
or ingested or if they penetrate the skin, may induce heritable
genetic defects or increase their incidence<
(n) substances and preparations which are toxic for
reproduction>
– substances and preparations which, if they are inhaled
or ingested or if they penetrate the skin, may produce, or
increase the incidence of, non-heritable adverse effects in the
progeny and,or an impairment of male or female reproductive
functions or capacity<
(o) substances and preparations which are dangerous for
the environment>
– substances and preparations which, were they to enter
the environment, would or could present an immediate or
delayed danger for one or more components of the
environment.
5.3. “Directive 67#548#EEC” shall mean Directive 67#548#EEC
of the European Community or equivalent provisions.
Special provisions concerning the labelling of certain preparations
For preparations classified as dangerous within the meaning of paragraphs 8, 9
and 10
1. Preparations sold to the general public
The labels on packaging containing such preparations, in addition to the specific
safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in
accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.
When such preparations are classified as very toxic (T + ), toxic (T) or corrosive
(C) and where it is physically impossible to give such information on the package
itself, packages containing such preparations must be accompanied by precise
and easily understandable instructions for use including, where appropriate,
instructions for the destruction of the empty package.
2. Preparations intended for use by spraying
The label on the packaging containing such preparations must compulsorily bear
the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in
accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.
3. Preparations containing a substance assigned phrase R33: Danger of cumulative
effects
When a preparation contains at least one substance assigned the phrase R33, the
label on the packaging of the preparation must carry the wording of this phrase as
set out in Annex III to Directive 67/548/EEC, when the concentration of this
substance present in the preparation is equal to or higher than 1 %, unless
different values are set in Annex I to Directive 67/548/EEC.
4. Preparations containing a substance assigned phrase R64: May cause harm to
breastfed babies
When a preparation contains at least one substance assigned phrase R64, the label
on the packaging of the preparation must carry the wording of this phrase as set
out in Annex III to Directive 67/548/EEC, when the concentration of this
substance present in the preparation is equal to or higher than 1 %, unless
different values are set in Annex I to Directive 67/548/EEC.
For preparations irrespective of their classification within the meaning of
Paragraphs 8, 9 and 10
1. Preparations containing lead
Paint and varnishes
The label on the packaging of paints and varnishes containing lead in quantities
exceeding 0.15 % (expressed as weight of metal) of the total weight of the
preparation, as determined in accordance with ISO standard 6503/1984, must
show the following particulars
"Contains lead. Should not be used on surfaces liable to be chewed or sucked by
children".
In the case of packages the contents of which are less than 125 millilitres, the
particulars may be as follows
"Warning! Contains lead".
2. Preparations containing cyanoacrylates
Adhesives
The label on the immediate packaging of adhesives based on cyanoacrylate must
bear the following inscriptions
"Cyanoacrylate
Danger
Bonds skin and eyes in seconds
Keep out of the reach of children."
Appropriate advice on safety must accompany the package.
3. Preparations containing isocyanates
The label on the packaging of preparations containing isocyanates (as monomers,
oligomers, prepolymers, etc., or as mixtures thereof) must bear the following
inscriptions
"Contains isocyanates.
See information supplied by the manufacturer."
Preparations containing epoxy constituents with an average molecular weight ≤
4. The label on the packaging of preparations containing epoxy constituents with an
average molecular weight ≤ 700 must bear the following inscriptions
"Contains epoxy constituents.
See information supplied by the manufacturer."
5. Preparations sold to the general public which contain active chlorine
The label on the packaging of preparations containing more than 1 % of active
chlorine must bear the following particular inscriptions
"Warning! Do not use together with other products. May release dangerous gases
(chlorine)."
6. Preparations containing cadmium (alloys) and intended to be used for brazing or
soldering
The label on the packaging of the above mentioned preparations must bear the
following inscription printed in clearly legible and indelible characters
"Warning! Contains cadmium.
Dangerous fumes are formed during use.
See information supplied by the manufacturer.
Comply with the safety instructions."
7. Preparations available as aerosols
Without prejudice to the provisions of these Regulations, preparations available as
aerosols are also subject to the labelling provisions in accordance with points 2.2
and 2.3 of the Annex to Directive 75/324/EEC as last amended by Directive
94/1/EC.
8. Preparations containing substances not yet tested completely
Where a preparation contains at least one substance which, in accordance with
Article 13.3 of Directive 67/548/EEC, bears the inscription "Caution - substance
not yet tested completely", the label on the packaging of the preparation must bear
the inscription "Caution - this preparation contains a substance not yet tested
completely" if this substance is present in a concentration ≥1 %.
9. Preparations not classified as sensitising but containing at least one sensitising
substance
The label on the packaging of preparations containing at least one substance
classified as sensitising and being present in a concentration equal to or greater
than 0.1 % or in a concentration equal to or greater than that specified under a
specific note for the substance in Annex I to Directive 67/548/EEC must bear the
inscription
"Contains (name of sensitising substance). May produce an allergic reaction."
10. Liquid preparations containing halogenated hydrocarbons
For liquid preparations which show no flashpoint or a flashpoint higher than 55
°C and contain a halogenated hydrocarbon and more than 5 % flammable or
highly flammable substances, the label on the packaging must bear the following
inscription as appropriate
"Can become highly flammable in use" or "Can become flammable in use".
11. Preparations containing a substance assigned phrase R67: vapours may cause
drowsiness and dizziness
When a preparation contains one or more substances assigned the phrase R67, the
label on the packaging of the preparation must carry the wording of this phrase as
set out in Annex III to Directive 67/548/EEC, when the total concentration of
these substances present in the preparation is equal to or higher than 15 %, unless
—
the preparation is already classified with phrases R20, R23, R26,
R68/20, R39/23 or R39/26,
—
or the preparation is in a package not exceeding 125 ml.
12. Cements and cement preparations
The label on the packaging of cements and cement preparations containing more
than 0.0002 % soluble chromium (VI) of the total dry weight of the cement must
bear the inscription
“Contains chromium (VI). May produce an allergic reaction”
unless the preparation is already classified and labelled as a sensitiser with phrase
R43.
For preparations not classified within the meaning of Paragraphs 8, 9 and 10
but containing at least one dangerous substance
1. Preparations not intended for the general public
The label on the packaging of the preparations referred to in paragraph 17.3 must
bear the following inscription
"Safety data sheet available for professional user on request".
1. The evaluation of the hazards of a preparation shall be based
on the determination of >
–
physico-chemical properties,
–
properties affecting health,
–
environmental properties.
These different properties shall be determined in accordance with
the provisions laid down in regulations 8, 9 and 10. Where laboratory
tests are conducted, they shall be carried out on the preparation as placed
on the market.
6.2. Where the determination of dangerous properties is carried
out in accordance with regulations 8, 9 and 10, all dangerous substances
within the meaning of regulation 5.2. and in particular those which>
–
are listed in Annex I to Directive 67#548#EEC,
– are listed in ELINCS in accordance with the Dangerous
Substances (Notification) Regulations, 2001,
– are classified and labelled provisionally by the person
responsible for the placing on the market in accordance with the
Dangerous Substances (Notification) Regulations, 2001,
– are classified and labelled in accordance with the
Dangerous Substances (Notification) Regulations, 2001 and are
not yet included in ELINCS,
– are covered by the Dangerous Substances (Notification)
Regulations, 2001,
– are classified and labelled in accordance with the
Dangerous Substances (Notification) Regulations, 2001,
shall be taken into consideration in accordance with the provisions laid
down in the method used.
6.3. For preparations covered by these regulations, dangerous
substances as referred to in regulation 5.2. which are classified as
dangerous on the basis of their health and#or environmental effects,
whether they are present as impurities or additives, shall be taken into
consideration when their concentration are equal to, or greater than,
those defined in the following table unless lower values are given in
Annex I to Directive 67#548#EEC, or in part B of the Second Schedule
to these Regulations or in Part B of the Third Schedule thereto, unless
otherwise specified in the Fifth Schedule to the Regulations.
Category of danger of the
Concentration to take
substance
into consideration for
Gaseous
Other
preparations
preparations
% vol#vol
% w#w
Very toxic
≥ 0.02
≥ 0.1
Toxic
≥ 0.02
≥ 0.1
Carcinogenic Category 1 or 2
≥ 0.02
≥ 0.1
Mutagenic 1 or 2
≥ 0.02
≥ 0.1
Toxic for reproduction Category 1 or 2
≥ 0.02
≥ 0.1
Harmful
≥ 0.2
≥ 1
Corrosive
≥ 0.02
≥ 1
Irritant
≥ 0.2
≥ 1
Sensitising
≥ 0.2
≥ 1
Carcinogenic Category 3
≥ 0.2
≥ 1
Mutagenic Category 3
≥ 0.2
≥ 1
Toxic for reproduction Category 3
≥ 0.2
≥ 1
Dangerous for the environment N
≥ 0.1
Dangerous for the environment ozone
≥ 0.1
≥ 0.1
Dangerous for the environment
≥ 1
Confidentiality for the chemical identity of a substance
PART A
Information to be communicated in the request for confidentiality
Introductory notes
Paragraph 18 indicates the conditions in which the person responsible for placing
a preparation on the market may avail himself of the confidentiality.
To avoid multiple requests for confidentiality relating to the same substance used
in different preparations, a single request for confidentiality may suffice if a certain
number of preparations have
-
the same dangerous constituents present in the same concentration range,
-
the same classification and labelling,
-
the same expected uses.
A single alternative denomination must be used to mask the chemical identity of
the same substance in the preparations concerned. Furthermore, the request for
confidentiality must contain all information indicated in the following request,
without forgetting the name or the trade name of each preparation.
The alternative designation used on the label must be the same as that given under
heading 2 "Composition/information on ingredients" of the Annex to Directive
91/155/EEC as last amended by Directive 93/112/EEC.
This implies that the alternative designation used will contain enough information
about the substance to ensure risk-free handling.
In making the request to use an alternative designation the person responsible for
placing on the market must take into account the need to provide enough information
for necessary health and safety precautions to be taken in the workplace and to ensure
that risks from handling the preparation can be minimised.
Request for confidentiality
In accordance with paragraph 18 the request for confidentiality must obligatorily contain
the following information
1. Name and full address (including telephone number) of the person established in
Malta or within the European Community who is responsible for placing the
preparation on the market (manufacturer, importer or distributor).
2. Precise identification of the substance(s) for which confidentiality is proposed and
the alternative designation.
CAS No
Einecs No
Chemical name according to
Alternative
international nomenclature
designation
and classification (Annex I to
Council Directive
67/548/EEC or provisional
classification)
(a)
(b)
(c)
NB: Where substances are classified provisionally, accompanying information
(bibliographical references) should be provided as evidence that the provisional
classification takes account of all existing pertinent information available on the
properties of the substance.
3. Justification for confidentiality (probability - plausibility).
4. Designation(s) or commercial name(s) of the preparation(s).
5. Is the designation or commercial name the same for all of the European
Community?
YES
NO
If no, specify the designation(s) or commercial name(s) used in the different
Member States
Austria
Belgium
Denmark
Germany
Greece
Finland
France
Spain
Sweden
Ireland
Italy
Luxembourg
Netherlands
Portugal
United Kingdom
6. Composition of the preparation(s) defined in point 2 of the Annex to Directive
91/155/EEC as last amended by Directive 93/112/EEC.
7. Classification of the preparation(s) according to paragraph 7 of these Regulations.
8. Labelling of the preparation(s) according to paragraph 11 of these Regulations.
9. Intended uses for the preparation(s).
10. Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by
Directive 93/112/EEC.
PART B
Lexicon guide for establishing the alternative designations (generic names)
1. Introductory note
The lexicon guide is based on the procedure for the classification of dangerous
substances (division of substances into families) which appears in Annex I to
Directive 67/548/EEC.
Alternative designations to those based on this guide may be used. However, in
all cases the names chosen must provide enough information to ensure the
preparation can be handled without risk and that necessary health and safety
precautions can be taken in the workplace.
The families are defined in the following manner
-
inorganic or organic substances whose properties are identified by having a
common chemical element as their chief characteristic. The family name is
derived from the name of the chemical element. These families are identified
as in Annex I by the atomic number of the chemical element (001 to 103),
-
organic substances whose properties are identified by having a common
-
functional group as their chief characteristics.
The family name is derived from the functional group name.
These families are identified by the conventional number found in Annex I (601-
650).
Sub-families bringing together substances with a common specific character have
been added in certain cases.
2. Establishing the generic name
General principles
For the purposes of establishing the generic name, the following general
approach, involving two successive stages, is adopted
(i) identification of the functional groups and chemical elements present in
the molecule;
(ii) determination of the extent to which account should be taken of the most
important functional groups and chemical elements.
The identified functional groups and elements taken into account are the names of
the families and sub-families set out in point 3 in the form of a non-restrictive list.
3. Division of substances into families and sub-families
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
Hydrogen compounds
- Hydrides
Helium compounds
Lithium compounds
Beryllium compounds
Boron compounds
- Boranes
- Borates
Carbon compounds
- Carbamates
- Inorganic carbon compounds
- Salts of hydrogen cyanide
- Urea and derivatives
Nitrogen compounds
- Quaternary ammonium compounds
- Acid nitrogen compounds
- Nitrates
- Nitrites
Oxygen compounds
Fluorine compounds
- Inorganic fluorides
Neon compounds
Sodium compounds
Magnesium compounds
- Organometallic magnesium derivatives
Aluminium compounds
- Organometallic aluminium derivatives
Silicon compounds
- Silicones
- Silicates
Phosphorus compounds
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
- Acid phosphorus compounds
- Phosphonium compounds
- Phosphoric esters
- Phosphates
- Phosphites
- Phosphoramides and derivatives
Sulphur compounds
- Acid sulphur compounds
- Mercaptans
- Sulphates
- Sulphites
Chlorine compounds
- Chlorates
- Perchlorates
Argon compounds
Potassium compounds
Calcium compounds
Scandium compounds
Titanium compounds
Vanadium compounds
Chromium compounds
- Chromium VI compounds
Manganese compounds
Iron compounds
Cobalt compounds
Nickel compounds
Copper compounds
Zinc compounds
- Organometallic zinc derivatives
Gallium compounds
Germanium compounds
Arsenic compounds
Selenium compounds
Bromine compounds
Krypton compounds
Rubidium compounds
Strontium compounds
Yttrium compounds
Zirconium compounds
Niobium compounds
Molybdenum compounds
Technetium compounds
Ruthenium compounds
Rhodium compounds
Palladium compounds
Silver compounds
Cadmium compounds
Indium compounds
Tin compounds
- Organometallic tin derivatives
Antimony compounds
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
Tellurium compounds
Iodine compounds
Xenon compounds
Caesium compounds
Barium compounds
Lanthanum compounds
Cerium compounds
Praseodymium compounds
Neodymium compounds
Promethium compounds
Samarium compounds
Europium compounds
Gadolinium compounds
Terbium compounds
Dysprosium compounds
Holmium compounds
Erbium compounds
Thulium compounds
Ytterbium compounds
Lutetium compounds
Hafnium compounds
Tantalum compounds
Tungsten compounds
Rhenium compounds
Osmium compounds
Iridium compounds
Platinum compounds
Gold compounds
Mercury compounds
- Organometallic mercury derivatives
Thallium compounds
Lead compounds
- Organometallic lead derivatives
Bismuth compounds
Polonium compounds
Astatine compounds
Radon compounds
Francium compounds
Radium compounds
Actinium compounds
Thorium compounds
Protactinium compounds
Uranium compounds
Neptunium compounds
Plutonium compounds
Americium compounds
Curium compounds
Berkelium compounds
Californium compounds
Einsteinium compounds
Fermium compounds
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
Mendelevium compounds
Nobelium compounds
Lawrencium compounds
Hydrocarbons
- Aliphatic hydrocarbons
- Aromatic hydrocarbons
- Alicyclic hydrocarbons
- Polycyclic aromatic hydrocarbons (PAH)
Halogenated hydrocarbons (*)
- Halogenated aliphatic hydrocarbons (*)
- Halogenated aromatic hydrocarbons (*)
- Halogenated alicyclic hydrocarbons (*)
(*) Specify according to the family corresponding to halogen.
Alcohols and derivatives
- Aliphatic alcohols
- Aromatic alcohols
- Alicyclic alcohols
- Alcanolamines
- Epoxy derivatives
- Ethers
- Glycolethers
- Glycols and polyols
Phenols and derivatives (*)
- Halogenated phenol derivatives (*)
(*) Specify according to the family corresponding to halogen.
Aldehydes and derivatives
- Aliphatic aldehydes
- Aromatic aldehydes
- Alicyclic aldehydes
- Aliphatic acetals
- Aromatic acetals
- Alicyclic acetals
Ketones and derivatives
- Aliphatic ketones
- Aromatic ketones (*)
- Alicyclic ketones
(*) Quinones included
Organic acids and derivatives
- Aliphatic acids
- Halogenated aliphatic acids (*)
- Aromatic acids
- Halogenated aromatic acids (*)
- Alicyclic acids
- Halogenated alicyclic acids (*)
- Aliphatic acid anhydrides
- Halogenated aliphatic acid anhydrides (*)
- Aromatic acid anhydrides
- Halogenated aromatic acid anhydrides (*)
- Alicyclic acid anhydrides
- Halogenated alicyclic acid anhydrides (*)
- Salts of aliphatic acid
- Salts of halogenated aliphatic acid (*)
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
- Salts of aromatic acid
- Salts of halogenated aromatic acid (*)
- Salts of alicyclic acid
- Salts of halogenated alicyclic acid (*)
- Esters of aliphatic acid
- Esters of halogenated aliphatic acid (*)
- Esters of aromatic acid
- Esters of halogenated aromatic acid (*)
- Esters of alicyclic acid (*)
- Esters of halogenated alicyclic acid (*)
- Esters of glycol ether
- Acrylates
- Methacrylates
- Lactones
- Acyl halogenides
(*) Specify according to the family corresponding to halogen.
Nitriles and derivatives
Nitro compounds
Chlornitrated compounds
Azoxy and azo compounds
Amine compounds
- Aliphatic amines and derivatives
- Alicyclic amines and derivatives
- Aromatic amines and derivatives
- Aniline and its derivatives
- Benzidine and its derivatives
Heterocyclic bases and derivatives
- Benzimidazole and derivatives
- Imidazol and derivatives
- Pyrethrinoids
- Quinoline and derivatives
- Triazine and derivatives
- Triazole and derivatives
Glycosides and alkaloids
- Alkaloid and derivatives
- Glycosides and derivatives
Cyanates and isocyanates
- cyanates
- isocyanates
Amides and derivatives
- Acetamide and derivatives
- Anilides
Organic peroxides
Enzymes
Complex coal derivatives
- Acid extract
- Alkaline extract
- Anthracene oil
- Anthracene oil extract residue
- Anthracene oil fraction
- Carbolic oil
- Carbolic oil extract residue
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
-
Coal liquids, liquid solvent extraction
-
Coal liquids, liquid solvent extraction solvents
-
Coal oil
-
Coal tar
-
Coal tar extract
-
Coal tar solids residue
-
Coke (coal tar) low temperature, high temperature pitch
-
Coke (coal tar) high temperature pitch
-
Coke (coal tar) mixed coal high temperature pitch
-
Crude benzole
-
Crude phenols
-
Crude tar bases
-
Distillate bases
-
Distillate phenols
-
Distillates
-
Distillates (coal), liquid solvent extraction, primary
-
Distillates (coal), solvent extraction, hydrocracked
-
Distillates (coal), solvent extraction, hydrocracked
hydrogenated middle
-
Distillates (coal), solvent extraction, hydrocracked middle
-
Extract residues (coal), low temperature coal tar alkaline
-
Fresh oil
-
Fuels, diesel, coal solvent extraction, hydrocracked,
hydrogenated
-
Fuels, jet aircraft, coal solvent extraction, hydrocracked,
hydrogenated
-
Gasoline, coal solvent extraction, hydrocracked naphtha
-
Heat treatment products
-
Heavy anthracene oil
-
Heavy anthracene oil redistillate
-
Light oil
-
Light oil extract residues, high boiling
-
Light oil extract residues, intermediate boiling
-
Light oil extract residues, low boiling
-
Light oil redistillate, high boiling
-
Light oil redistillate, intermediate boiling
-
Light oil redistillate, low boiling
-
Methylnaphthalene oil
-
Methylnaphthalene oil extract residue
-
Naphtha (coal), solvent extraction, hydrocracked
-
Naphthalene oil
-
Naphthalene oil extract residue
-
Naphthalene oil redistillate
-
Pitch
-
Pitch redistillate
-
Pitch residue
-
Pitch residue, heat treated
-
Pitch residue, oxidised
-
Pyrolysis products
-
Redistillates
-
Residues (coal), liquid solvent extractions
-
Tar brown coal
-
Tar brown coal, low temperature
Family No
Families & Sub-families
Annex I to Directive
67/548/EEC
- Tar oil, high boiling
- Tar oil, intermediate boiling
- Wash oil
- Wash oil extract residue
- Wash oil redistillate
Complex oil derivatives
- Crude oil
- Petroleum gas
- Low boiling point naphtha
- Low boiling point modified naphtha
- Low boiling point cat-cracked naphtha
- Low boiling point cat-reformed naphtha
- Low boiling point thermally cracked naphtha
- Low boiling point hydrogen treated naphtha
- Low boiling point naphtha – unspecified
- Straight-run kerosene
- Kerosene – unspecified
- Cracked gas oil
- Gas oil – unspecified
- Heavy fuel oil
- Grease
- Unrefined or mildly refined base oil
- Base oil – unspecified
- Distillate aromatic extract
- Distillate aromatic extract (treated)
- Foots oil
- Slack wax
- Petrolatum
Various substances
- Do not use this family. Instead, use the families or sub-
families mentioned above.
4. Practical application
After having conducted a search to see if the substance belongs to one or more
families or sub-families on the list, the generic name can be established in the
following way
If the name of a family or sub-family is sufficient to characterise the chemical
elements or important functional groups, this name will be chosen as the generic
name.
Examples
-
1,4 dihydroxybenzene
family 604: phenols and derivatives
generic name: phenol derivatives
-
butanol
family 603: alcohols and derivatives
sub-family: aliphatic alcohols
generic name: aliphatic alcohol
-
2-Isopropoxyethanol
family 603: alcohols and derivatives
sub-family: glycolethers
generic name: glycolether
-
methacrylate
family 607: organic acids and derivatives
sub-family: acrylates
generic name: acrylate
If the name of a family or sub-family is not sufficient to characterise the chemical
elements of important functional groups, the generic name will be a combination
of the corresponding different family or sub-family names
Examples
-
chlorobenzene
family 602: halogenated hydrocarbons
sub-family: halogenated aromatic hydrocarbons
family 017: chlorine compounds
generic name: chlorinated aromatic hydrocarbon
-
2,3,6-trichlorophenylacetic acid
family 607: organic acids
sub-family: halogenated aromatic acids
family 017: chlorine compounds
generic name: chlorinated aromatic acid
-
1-chloro-1-nitropropane
family 610: chloronitrated derivatives
family 601: hydrocarbons
sub-family: aliphatic hydrocarbons
generic name: chlorinated aliphatic hydrocarbon
-
tetrapropyl dithiopyrophosphate
family 015: phosphorus compounds
sub-family: phosphoric esters
family 016: sulphur compounds
generic name: thiophosphoric ester
NB: In the case of certain elements, notably metals, the name of the family or
sub-family may be indicated by the words "organic" or "inorganic".
Examples
-
dimercury chloride
family 080: mercury compounds
generic name: inorganic mercury compound
-
barium acetate
family 056: barium compounds
generic name: organic barium compound
-
ethyl nitrite
family 007: nitrogen compounds
sub-family: nitrites
generic name: organic nitrite
-
sodium hydrosulphite
family 016: sulphur compounds
generic name: inorganic sulphur compound
(The examples cited are substances taken from Annex I to Directive 67/548/EEC
(19th adaptation) in respect of which requests for confidentiality may be
submitted).
1. The classification of dangerous preparations according to
the degree and specific nature of the hazards involved shall be based on
the definitions of categories of danger laid down in regulation 5.2.
7.2. The general principles of the classification and labelling of
preparations shall be applied in accordance with the criteria laid down
in Annex VI to Directive 67#548#EEC, save where alternative criteria
referred to in regulations 8, 9, 10 or 13 and the relevant Schedules of
these Regulations are applied.
Preparations covered by paragraph 15.2
Preparations as specified by paragraph 9.3 of Annex VI to Directive 67/548/EEC.
1. The hazards of a preparation deriving from its physico-
chemical properties shall be assessed by determining, by means of the
chemical properties.
methods specified in Part A of Annex V to Directive 67#548#EEC, the
physico-chemical properties of the preparation necessary for appropriate
classification and labelling in accordance with the criteria laid down in
Annex VI to that Directive.
8.2. By way of derogation from regulation 8.1>
The determination of the explosive, oxidising, extremely
flammable, highly flammable, or flammable properties is not necessary
provided that>
– none of the constituents possesses such properties and
that, on the basis of the information available to the manufacturer,
the preparation is unlikely to present hazards of this kind,
– in the event of a change in the composition of a preparation
of known composition, scientific evidence indicates that a
reassessment of the hazards will not lead to a change in
classification,
– preparation placed on the market in the form of aerosols
satisfy the provisions of the Aerosols Dispensers Regulations, 2002.
8.3. For certain cases for which the methods laid down in Part A
of Annex V to Directive 67#548#EEC are not appropriate, alternative
calculation methods are laid down in Part B of the First Schedule to
these regulations.
8.4. Certain exemptions from the application of the methods laid
down in Part A of Annex V to Directive 67#548#EEC are referred to in
Part A of the First Schedule to these regulations.
8.5. The hazards deriving from the physico-chemical properties
of a preparation covered by the Plant Protection Products Regulations,
2004 or equivalent provisions shall be assessed by determining the
physcio-chemical properties of the preparation necessary for appropriate
classification in accordance with the criteria set out in Annex VI to
Directive 67#548#EEC. These properties shall be determined by means
of the methods laid down in Part A of Annex V to Directive 67#548#EEC
unless other internationally recognised methods are acceptable in
accordance with the provisions of the Second and Third Schedules to
the Plant Protection Products Regulations, 2004.
1. The health hazards of a preparation shall be assessed by one Evaluation of health
hazards.
or more of the following procedures>
(a) by a conventional method described in the Second
Schedule<
(b) by determining the toxicological properties of the
preparation necessary for appropriate classification in accordance
with the criteria in Annex VI to Directive 67#548#EEC. These
properties shall be determined by means of the methods laid down
in Part B of Annex V to Directive 67#548EEC, unless, in the case
of plant protection products, other internationally recognised
methods are acceptable in accordance with the provisions of the
First and Second Schedules to the Plant Protection Products
Regulations, 2004.
9.2. Without prejudice to the requirements of the Plant Protection
Products Regulations 2004, or equivalent provisions, only where it can
be scientifically demonstrated by the person responsible for placing the
preparation on the market that the toxicological properties of the
preparation cannot correctly be determined by the method outlined in
regulation 9.1. (a), or on the basis of existing test results on animals, the
methods outlined in regulation 9.2. (b) may be used, provided they are
justified or specifically authorised under the Animal Welfare Act.
9.2.1. When a toxicological property is established by the
methods outlined in regulation 7.1. (b) to obtain new data, the test shall
be conducted in compliance with the principles of good laboratory
practice provided for in the Good Laboratory Practice Regulations, 2004
and the provisions in the Animal Welfare Act.
9.2.2. Subject to the provisions of regulation 9.3., where a
toxicological property has been established on the basis of both the
methods outlined in regulations 9.1. (a) and (b), the results from the
methods outlined in regulation 9.1. (b) shall be used for classifying the
preparation, except in the case of carcinogenic, mutagenic or toxic effects
for reproduction for which only the method outlined in 9.1. (a) shall be
used.
9.2.3. Any of the toxicological properties of the preparation which
are not assessed by the method outlined in regulation 9.1. (b) shall be
assessed in accordance with the method outlined in regulation 9.1. (a).
9.3. Furthermore, where it can be demonstrated>
– by epidemiological studies, by scientifically valid case
studies as specified by Annex VI to Directive 67#548#EEC or by
statistically backed experience, such as the assessment of data from
poison information units or concerning occupational diseases, that
toxicological effects on man differ from those suggested by the
application of methods outlined in regulation 9.1., then the
preparation shall be classified according to its effects on man,
– that, owing to effects such as potentiation, a conventional
assessment would underestimate the toxicological hazard, those
effects shall be taken into account in classifying the preparation,
– that, owing to effects such as antagonism, a conventional
assessment would overestimate the toxicological hazard, those
effects shall be taken into account in classifying the preparation.
9.4. For preparations of a known composition, with the exception
of those covered by the Plant Protection Products Regulations, 2004 or
equivalent provisions, classified in accordance with regulation 9.1. (b),
a new evaluation of health hazard by the methods outlined in either
regulation 9.1. (a) or (b) shall be performed whenever>
– changes of composition of the initial concentration, as a
weight#weight or volume#volume percentage, of one or more of
the dangerous constituents are introduced by the manufacturer, in
accordance with following table>
Initial concentration range of
Permitted variation in initial
the constituent
concentration of the constituent
≤ 2.5 %
± 30 %
› 2.5 ≤ 10 %
± 20 %
› 10 ≤ 25 %
± 10 %
› 25 ≤ 100 %
± 5 %
– changes of composition involving the substitution or
addition of one or more constituents, which may or may not be
dangerous within the definitions set out in paragraph 5.2, are
introduced by the manufacturer.
This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard will not
result in a change of classification.
1. The hazards of a preparation for the environment shall be Evaluation of
environmental
assessed by one or more of the following procedures>
hazards.
(a) by a conventional method described in the Third
Schedule to these regulations<
(b) by determining the hazardous properties of the
preparation for the environment necessary for appropriate
classification in accordance with the criteria set out in Annex VI
to Directive 67#548#EEC. These properties shall be determined by
means of the methods laid down in Part C of Annex V to Directive
67#548#EEC unless, in the case of plant protection products, other
internationally recognised methods are acceptable in accordance
with provisions of the Second and Third Schedule of the Plant
Protection Regulations. Without prejudice to the testing
requirements set out in the Plant Protection Regulations 2004, the
conditions for application of the test methods are described in Part
C of the Third Schedule to these regulations.
10.2. When an Ecotoxicological property is established by one
of the methods outlined in paragraph 10.1. (b) to obtain new data, the
test shall be conducted in compliance with the principles of good
laboratory practice provided for in the Good Laboratory Practice
Regulations, 2004 and the provisions in the Animal Welfare Act. Where
the environmental hazards have been assessed in compliance with both
the procedures mentioned above, the results of the methods referred to
in paragraph 10.1. (b) shall be used for classifying the preparation.
10.3. For preparations of a known composition, with the
exception of those covered by the Plant Protection Products Regulations
or equivalent provisions, classified in accordance with method outlined
in paragraph 10.1.(b), a new evaluation of environmental hazard either
by the method outlined in paragraph 8.1.(a) or that outlined in paragraph
8.1.(b) shall be performed whenever>
– changes of composition of the initial concentration, as a
weight#weight or volume#volume percentage, of one or more of
the dangerous constituents are introduced by the manufacturer, in
accordance with following table>
Initial concentration range of
Permitted variation in initial
the constituent
concentration of the constituent
≤ 2.5 %
± 30 %
› 2.5 ≤ 10 %
± 20 %
› 10 ≤ 25 %
± 10 %
› 25 ≤ 100 %
± 5 %
– changes of composition involving the substitution or
addition of one or more constituents, which may or may not be
dangerous within the definitions set out in paragraph 5.2, are
introduced by the manufacturer.
This new evaluation will apply unless there is valid scientific
justification for considering that a re-evaluation of the hazard will not
result in a change of classification.
1. Preparations covered by these regulations cannot be placed Prohibition of
marketing.
on the market unless they comply with it.
11.2. In order to ensure compliance with these regulations, the
Director may request information on the composition of the preparation
and any other pertinent information from any person responsible for
placing the preparation on the market.
11.3. The Director shall take all necessary measures to ensure
that those responsible for placing the preparation on the market hold at
his disposal>
– the data used for the classification and labelling of the
preparation,
– any pertinent information relating to packaging
requirements in accordance with paragraph 12.1.3, including the
test certificate issued in accordance with Part A of Annex IX to
Directive 67#548#EEC,
– the data used for establishing the safety data sheet, in
accordance with paragraph 15.
1. Preparations within the meaning of paragraph 4.2. and Packaging.
preparations covered by the Fourth Schedule pursuant to paragraph 4.3.
cannot be placed on the market unless their packaging satisfies the
following requirements>
– it shall be so designed and constructed that its contents
cannot escape< this requirement shall not apply where special
devices are prescribed,
– the materials constituting the packaging and fastening
must not be susceptible to adverse attack by the contents, or liable
to form dangerous compounds with the contents,
– packaging and fastenings must be strong and solid
throughout to ensure that they will not loosen and will safely meet
the normal stresses and strains of handling,
– containers fitted with replaceable fastening devices shall
be so designed that the packaging can be fastened repeatedly
without the contents escaping<
12.2. Containers which contain preparations within the meaning
of paragraph 4.2. and preparations covered by the Fourth Schedule
pursuant to paragraph 4.3. offered or sold to the general public must
not have>
– either a shape and#or graphic decoration likely to attract
or arouse the active curiosity of children or to mislead consumers,
or
– a presentation and#or a designation used for foodstuffs or
animal feedingstuffs or medicinal or cosmetic products.
12.3. Containers which contain certain preparations offered or
sold to the general public covered by the Fourth Schedule to these
regulations must>
–
be fitted with child-resistant fastenings, and#or
–
carry a tactile warning of danger.
The devices must conform to the technical specifications given in
Parts A and B of Annex IX to Directive 67#548#EEC.
12.4. The packaging of preparations shall be deemed to satisfy
the requirements of paragraphs 12.1. to 12.3. if it complies with the
requirements for carriage of dangerous goods by rail, road, inland,
waterway, sea or air.
1. Preparations within the meaning of paragraph 4.2. cannot
be placed on the market unless the labelling on their packaging satisfies
all the requirements of paragraph 13.2. and the specific provisions of
Part A and B of the Fifth Schedule<
Preparations within the meaning of paragraph 4.3. as defined in
Parts B and C of the Fifth Schedule cannot be placed on the market
unless the labelling on their packaging satisfies the requirements of
paragraphs 13.2.1. and 13.2.2. and the specific provisions of Parts B
and C of the Fifth Schedule.
13.1.1. With respect to plant protection products subject to the
Plant Protection Products Regulations 2004, or equivalent provisions,
the labelling requirements in accordance with these Regulations shall
be accompanied by the following wording>
“To avoid risks to man and the environment, comply with
the instructions for use.”
This labelling shall be without prejudice to the information required
by the Plant Protection Products Regulations 2004.
13.2. The following information shall be clearly and indelibly
marked on any package>
13.2.1. the trade name or designation of the preparation<
13.2.2. the name, full address and telephone number of the person
established in the European Community who is responsible for placing
the preparation on the market, whether it be the manufacturer, the
importer or the distributor<
13.2.3. the chemical name of the substance or substances present
in the preparation in accordance with the following detailed rules>
– for preparations classified as T+, T, Xn in accordance with
paragraph 9, only the substances T+, T, Xn present in
concentrations equal to, or greater than, the lowest limit (limit Xn)
for each of them laid down in Annex I to Directive 67#548#EEC
or, failing that, Part B of the Second Schedule to these regulations
have to be taken into consideration<
– for preparations classified C in accordance with paragraph
9, only C substances present in concentrations equal to, or greater
than, the lowest limit (limit Xi) laid down in Annex I to Directive
67#548#EEC or failing that, Part B of the Second Schedule to these
regulations have to be taken into consideration<
– the name of the substances which have given rise to the
classification of the preparation in one or more of the following
hazard categories>
–
carcinogen category 1, 2 or 3,
–
mutagen category 1, 2 or 3,
–
toxic for reproduction category 1, 2 or 3,
– very toxic, toxic or harmful due to non-lethal effects
after a single exposure,
– toxic or harmful due to severe effects after repeated
or prolonged exposure,
–
sensitising<
shall be mentioned on the label.
The chemical name shall be one of the designations listed in Annex
I to Directive 67#548#EEC or an internationally recognised chemical
nomenclature if no corresponding designation is yet listed in that Annex.
– As a consequence of the above provisions the name of
any substance which led to the classification of the preparation in
the following hazard categories>
–
explosive,
–
oxidising,
–
extremely flammable,
–
highly flammable,
–
flammable,
–
irritant,
–
dangerous for the environment<
need not be mentioned on the label unless the substance has to be
mentioned pursuant to the first, second or third indents of paragraph
13.2.3.
– As a general rule, a maximum of four chemical names
shall suffice to identify the substances primarily responsible for
the major health hazards which have given rise to the classification
and the choice of the corresponding phrases referring to the risk
involved. In some cases, more than four chemical names may be
necessary.
13.2.4. The danger symbol(s), where specified in these
regulations, and indication(s) of hazards involved in the use of the
preparation, shall be in accordance with the wording of Annexes II and
VI to Directive 67#548#EEC and shall be applied in accordance with
the evaluation of the hazards carried out in accordance with the First,
Second and Third Schedules to these Regulations.
Where more that one danger symbol must be assigned to a
preparation the obligation to apply the symbol>
– T shall make the symbols C and Xn optional unless
otherwise specified in Annex I to Directive 67#548#EEC,
–
C shall make the symbol Xi optional,
–
E shall make the symbol F and O optional,
–
Xn shall make the symbol Xi optional.
The symbol(s) shall be printed in black on an orange-yellow
background.
13.2.5. The indications concerning special risks (R phrases) shall
comply with the wording in Annexes III and VI to Directive 67#548#EEC
and shall be assigned in accordance with results of the hazard evaluation
carried out in accordance with the First, Second and Third Schedules to
these regulations.
As a general rule, a maximum of six R phrases shall suffice to
describe the risks< for this purpose, the combined phrases listed in Annex
III to Directive 67#548#EEC shall be regarded as single phrases.
However, if the preparation falls within more than one danger category,
those standard phrases shall cover all the principal hazards associated
with the preparation. In some cases more than six R phrases may be
necessary.
The standard phrases “extremely flammable” or “highly
flammable” need not be used where they describe an indication of danger
used in accordance with paragraph 13.2.4.
13.2.6. The indications giving safety advice (S phrases) shall
comply with the wording in the Fourth Schedule and with Annex VI to
Directive 67#548#EEC and shall be assigned in accordance with the
results of the hazard evaluation carried out in accordance with the First,
Second and Third Schedules to these regulations.
As a general rule, a maximum of six S phrases shall suffice to
formulate the most appropriate safety advice< for this purpose the
combined phrases listed in Annex IV to Directive 67#548#EEC shall be
regarded as single phrases. However, in some cases more than six S
phrases may be necessary.
Where it is physically impossible to include the advice on the label
or package itself, the package shall be accompanied by safety advice
on the use of the preparation.
13.2.7. The nominal quantity (nominal mass or nominal volume)
of the contents in the case of preparations offered or sold to the general
public.
13.3. For certain preparations classified as dangerous within the
meaning of paragraph 10, by way of derogation from paragraphs 13.2.4.,
13.2.5., and 13.2.6., exemptions to certain provisions on the
environmental labelling or specific provisions in relation to the
environmental labelling may be determined in accordance with the
procedure referred to in Article 20 of Directive 1999#45#EC, where it
can be demonstrated that there would be a reduction in the environmental
impact. These exemptions or specific provisions are defined and laid
down in Part A or B of the Fifth Schedule.
13.4. If the contents of the package do not exceed 125ml>
– in the case of preparations that are classified as highly
flammable, oxidising, irritant, with the exception of those assigned
R41, or dangerous for the environment and assigned the N symbol
it shall not be necessary to indicate the R phrases or the S phrases,
– in the case of preparations that are classified as flammable
or dangerous for the environment and not assigned the N symbol
it shall be necessary to indicate the R phrases but it shall not be
necessary to indicate the S phrases.
13.5. Without prejudice to Article 16.4. of the Plant
Protection Products Regulations 2004, indications such as “non-
toxic”, “non-harmful”, “non-polluting”, “ecological” or any other
statement indicating that the preparation is not dangerous or likely
to lead to underestimation of the dangers of the preparation in
question shall not appear on the packaging or labelling of any
preparation subject to these Regulations.
1. Where the particulars required by paragraph 13 appear on Implementation of
the Labelling
a label, that label shall be firmly affixed to one or more surfaces of the Requirements.
packaging so that those particulars can be read horizontally when the
package is set down normally. The dimensions of the label are laid
down in Annex VI to Directive 67#548#EEC and the label is intended
solely for provision of the information required by this Directive and if
necessary of any supplementary health or safety information.
14.2. A label shall not be required when the particulars are clearly
shown on the package itself, as specified in paragraph 14.1.
14.3. The colour and presentation of the label - or, in the case of
paragraph 14.2, of the package - shall be such that the danger symbol
and its background stand out clearly from it.
14.4. The information required on the label under paragraph 13
shall stand out clearly from its background and shall be of such size and
spacing as to be easily read.
Any specific provisions regarding the presentation and format of
this information laid down in Annex VI to Directive 67#548#EEC shall
be applicable.
14.5. Preparations covered by these Regulations must be labelled
in at least one of the official languages of Malta.
14.6. For the purposes of these Regulations, labelling
requirements shall be deemed to be satisfied>
(a) in the case of an outer package containing one or more
inner packages, if the outer package is labelled in accordance with
international rules on the transport of dangerous goods and the
inner package or packages are labelled in accordance with these
Regulations<
(b) in the case of a single package>
– if such a package is labelled in accordance with
international rules on the transport of dangerous goods and
with paragraphs 13.2.1, 13.2.2, 13.2.3, 13.2.5 and 13.2.6< for
preparations classified according to paragraph 10, the
provisions of paragraph 13.2.4 shall additionally apply with
respect to the property in question when it has not been so
identified on the label, or
– where appropriate, for particular types of packaging
such as mobile gas cylinders, if the specific requirements
referred to in Annex VI to Directive 67#548#EEC are complied
with.
1 Paragraphs 12, 13 and 14 shall not apply to explosives placed
on the market with a view to obtaining an explosive or pyrotechnic
effect.
15.2 For certain dangerous preparations within the meaning of
paragraphs 8, 9 or 10 defined in the Seventh Schedule which, in the
form in which they are placed on the market, do not present any physico-
chemical risk, or risk to health or to the environment, paragraphs 12, 13
and 14 shall not apply.
15.3 The Director may also, on the advice of the Malta Standards
Authority>
(a) permit the labelling required by paragraph 13 to be
applied in some other appropriate manner on packages which are
either too small or otherwise unsuitable for labelling in accordance
with Article 14.1 and 14.2<
(b) by way of derogation from paragraphs 13 and 14 permit
the packaging of dangerous preparations which are classified as
harmful, extremely flammable, highly flammable, flammable,
irritant or oxidising to be unlabelled or to be labelled in some other
way, if they contain such small quantities that there is no reason to
fear any danger to persons handling such preparations or to other
persons<
(c) by way of derogation from paragraphs 13 and 14, for
preparations classified according to paragraph 10, permit the
packaging of dangerous preparations to be unlabelled or labelled
in some other way if they contain such small quantities that there
is no reason to fear any dangers to the environment<
(d) by way of derogation from paragraphs 13 and 14 permit
the packaging of dangerous preparations which are not mentioned
in (b) or (c) above to be labelled in some other appropriate way, if
the packages are too small for the labelling provided for in
paragraphs 13 and 14 and there is no reason to fear any danger to
persons handling such preparations or to other persons.
Where this paragraph is applied, the use of symbols, indications
of danger, risk (R) phrases or safety (S) phrases different to those laid
down in these Regulations shall not be permitted.
1. Any advertisement for a preparation within the meaning Distance Selling.
of these Regulations which enables a member of the general public to
conclude a contract for purchase without first having sight of the label
for that preparation must make mention of the type or types of hazard
indicated on the label. This requirement is without prejudice to the
provisions of the Consumer Affairs Act on the protection of consumers
in respect of distance contracts.
1 The safety data sheet information is principally intended Safety Data Sheet.
for use by professional users and must enable them to take the necessary
measures as regards the protection of health, safety and the environment
at the place of work.
17.2 The person responsible for placing on the market a
preparation within the meaning of paragraph 4.2 shall provide a safety
data sheet.
17.3 The person responsible for placing on the market a
preparation shall provide on request of a professional user a safety data
sheet providing proportionate information for preparations not classified
as dangerous within the meaning of paragraphs 8, 9 and 10 but containing
in an individual concentration of ≤ 1 % by weight for non-gaseous
preparations and ≤ 0,2 % by volume for gaseous preparations at least>
–
one substance posing health or environmental hazards, or
– one substance for which there are workplace exposure
limits established by the European Community.
17.4 The safety data sheet and its supply must comply with the
provisions of the Dangerous Substances and Preparations (Safety Data
Sheets) Regulations 2002 or equivalent provisions.
17.5 The safety data sheet may be supplied on paper or
electronically, provided that the addressee has the necessary means of
receiving it.
1 Where the person responsible for placing the preparation Confidentiality of
on the market can demonstrate that the disclosure on the label or safety Chemical Names.
data sheet of the chemical identity of a substance which is exclusively
classified as>
– irritant with the exception of those assigned R41 or irritant
in combination with one or more of the other properties mentioned
in the fourth indent of paragraph 13.2.3, or
– harmful or harmful in combination with one or more of
the properties mentioned in the fourth indent of paragraph 13.2.3
presenting acute lethal effects alone
will put at risk the confidential nature of his intellectual property, he
may, in accordance with the provisions of the Sixth Schedule be
permitted to refer to that substance either by means of a name that
identifies the most important functional chemical groups or by means
of an alternative name. This procedure may not be applied where the
substance concerned has been assigned an exposure limit by the
European Community.
Where the person responsible for placing a preparation on the
market wishes to take advantage of confidentiality provisions, he shall
make a request to the Director.
This request must be made in accordance with the provisions of
the Sixth Schedule and must provide the information required in the
form in Part A of that Schedule. The Director may nevertheless request
further information from the person responsible for placing the
preparation on the market if such information appears necessary in order
to evaluate the validity of the request.
The Director, when receiving a request for confidentiality shall
notify the applicant of his decision.
The Director shall recognise a decision pursuant to a request for
confidentiality taken by the competent authority of a Member State of
the European Community, provided that a copy of such decision has
been duly forwarded to him by the person responsible for placing the
preparation on the Maltese market.
Confidential information brought to the attention of the Director
shall be treated in accordance with the Provisions of the Dangerous
Substances (Notification) Regulations.
1 These Regulations shall apply without prejudice to other
requirements deemed necessary to ensure that workers are protected
when using the dangerous preparations in question, provided that this
does not mean that the classification, packaging, and labelling of
dangerous preparations are modified in a way not provided for in these
Regulations.
1 Where the Director has detailed evidence that a preparation, Safeguard Clause.
although satisfying the provisions of these Regulations, constitutes a
hazard for man or the environment on grounds relating to the provisions
of these Regulations, he may, on the advice of the Directorate responsible
for chemicals within the Malta Standards Authority, provisionally
prohibit the placing on the market of that preparation or subject it to
special conditions.
19.1 The Dangerous Substances and Preparations Regulations, Repeal of L.N. 221
2002 are hereby repealed and any reference to those regulations shall of 2002.
be construed as a reference to these regulations.