MT
DANGEROUS SUBSTANCES AND PREPARATIONS REGULATIONS
Table of Provisions (27)
Statutory Text (27 Articles)
SUBSIDIARY LEGISLATION 427.28
DANGEROUS SUBSTANCES AND PREPARATIONS
REGULATIONS
16th January, 2007
LEGAL NOTICE 10 of 2007, as amended by Legal Notices 221 and 309
of 2007, 267 of 2009 and 337 of 2013.
The title of these regulations is the Dangerous Substances
and Preparations Regulations.
Methods for the evaluation of physico-chemical properties of preparations
in accordance with regulation 8
PART A
Exemptions to test methods of Annex V - Part A to Directive 67/548/EEC
See point 2.2.5 of Annex VI to Dircctivc 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 Dircctive 67/548/EEC.
B.2. Gaseous preparations
1. Method for the determination of oxidising properties
See point 9.1.1.2 of Annex VI to Directive 67/548/EEC.
2. Method for the determination of flammability properties
See point 9.1.1.1 of Annex VI to Directive 67/548/EEC.
Preparations that fail to comply with the provisions of
these regulations shall not be placed on the market by
manufacturers or importers.
Amended by
L.N. 267 of 2009.
Methods for the evaluation of health hazards of
preparations in accordance with regulation 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
7.1(a) by the conventional method described in Parts A and B of this Schedule using
indvidual concentration limits.
(a) where the dangerous substances listed in Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures 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 Part 3 of Annex VI to Regulation (EC) No 1272/2008
of the European Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures, 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures 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
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 height 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures for the substance or substances under
consideration, or
(b) the concentration specified at point 2 in Part B of this Schcdule (Table II
and II A) where the substance or substances do not appear in Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures 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
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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures 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
Σ ( P L Xn T+ + L P Xn T + P L Xn Xn ) > 1
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
R65/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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures or appear in it without
concentration limits;
3.4. 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
(a) either the concentration specified in Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits.
4. The following preparations are to be classified as corrosive
4.1. and assigned the symbol "C", the indication of danger "corrosive" and the
risk phrase R35;
4.1.1. preparations containing one or more substances classfied as corrosive to
which is assigned the phrase R35 in individual concentrations equal to or greater
(a) either the concentration specified in Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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
Σ ( P L C,R35
) > 1
C,R35
where
P C,R35 is the pcrccnt:lgc 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;
4.2. and assigned the symbol "C", the indication of danger "corrosive" and the
risk phrase R34;
4.2.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
4.2.2. preparations containing more than one of the substances classified as
cor r os ive to wh ich is ass ign ed the p h rase R 3 5 o r R3 4 i n lo wer ind iv idu al
concentrations than the limits specified under 4.2.1(a) or (b) if
Σ ( P L C,R34
+ C,R34 ) > 1
P
C,R35
L C,R34
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
5.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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 classificd 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
Σ ( L P Xi,R41
+ C,R34 + Xi,R41 ) > 1
P
P
C,R35
L Xi,R41
L Xi,R41
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 preparrtion,
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;
5.2. irritant to eyes and assigned the symbol "X i ", the indication of danger
"irritant" and the risk phrase R36;
5.2.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
5.2.2. 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
Σ ( L P Xi,R36
+ C,R34 + Xi,R41 + Xi,R36 ) > 1
P
P
P
C,R35
L Xi,R36
L Xi,R36
L Xi,R36
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;
5.3. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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
Σ ( L P Xi,R38
+ C,R34 + Xi,R38 ) > 1
P
P
C,R35
L Xi,R38
L Xi,R38
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;
5.4. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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
Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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
Σ ( P L Xi,R37
) > 1
Xi,R37
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
Σ ( L P Xi,R37
+ C,R34 + Xi,R37 ) > 1
P
P
C,R35
L Xi,R37
L Xi,R37
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
6.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures or appear in it without
concentration limits;
6.2. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament
and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures or appear in it without
concentration limits.
7. The following preparattions are to be classified as carcinogenic
7.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
7.2. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits.
8. The following preparations are to be classified as mutagenic
8.1. those of category 1 or 2 which are assigned the symbol "T" and the phrase
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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
8.2. 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
(a) either the concentration specified in Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits.
9. The following preparations are to be classified as toxic for reproduction
9.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
9.2. those of category 3 which are assigned the symbol "X n " and the phrase R62
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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
9.3. those of category 1 or 2 which are assigned the symbol "T" and the phrase
R61 (development).
preparations contaning 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures for the substance or substances under
consideration, or
(b) the concentration specified at point 6 in Part B of this Schedule (Table
VI arnd VI A) where the substance or substances do not appear in Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures or
appear in it without concentration limits;
9.4. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the
classification, labelling and packaging of substances and mixtures 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
li m its ( ex p re ss ed as a v o lu m e/v o lu m e p er cen tag e) to be us ed f o r g aseo u s
preparations. These concentrauon limits are used in the absence of specific
concentration limits for the substance under consideration in Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16
December 2008 on the classification, labelling and packaging of substances and
mixtures.
1. Acute lethal effects
1.1. Non-gaseous preparations
The concentration limits fixed in Table 1, expressed as a weight/weight
percentage, determine the classification of the preparation in relation to the
individual concentration of the substancc(s) present whose classification is also
shown.
Table I
Classification of the preparation
Classification of the
T +
substance
T
X n
T + with R26, R27, R28 concentration > 7%
1%
1%
< concentration < 7% < concentration < 1%
T with R23, R24, R25
concentration > 25%
3%
< concentration < 25%
X n with R20, R21, R22
concentration > 25%
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.
DANGEROUS SUBSTANCES AND PREPARATIONS
Table I A
Classification of the gaseous preparation
Classification of the
T +
substance (gas)
T
X n
+
T with R26, R27, R28 concentration > 1%
0.2%
0.02%
< concentration < 1% < concentration < 0.2%
T with R23, R24, R25
concentration > 5%
0.5%
< concentration < 5%
X n with R20, R21, R22
concentration > 5%
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
2.1. Non-gaseous preparations
For substances that produce non-lethal irreversible effects after a single
ex p o su r e ( R 3 9 / r o u t e o f ex p o su r e, R 6 8 / r o u t e o f ex p o su r e) , t h e i n d i v id u a l
concentration limits specified in Table II, expressed as a weight/weight percentage,
determine, when appropriate, the classification of the preparation.
Table II
Classification of the preparation
Classification of the
T +
substance
T
X n
+
T with R39/rou te concentration > 10%
1%
0.1%
of exposure
R39(*) obligatory < concentration < 10% < concentration < 1%
R39(*) obligatory
R68(*) obligatory
T with R39/route of
concentration > 10%
1%
exposure
R39(*) obligatory
< concentration < 10%
R68(*) obligatory
X n with R68/route
concentration > 10%
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.
2.2. 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 the gaseous preparation
Classification of the
T +
substance (gas)
T
X n
+
T with R39/rou te concentration > 1%
0.2%
0.02%
of exposure
R39(*) obligatory < concentration < 1% < concentration < 0.2%
R39(*) obligatory
R68(*) obligatory
T with R39/route of
concentration > 5%
0.5%
exposure
R39(*) obligatory
< concentration < 5%
R68(*) obligatory
X n with R68/route
concentration > 5%
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
3.1. 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 preparation
Classification of the substance
T
X n
T with R48/route of exposure
concentration > 10%
1% < concentration < 10%
R48(*) obligatory
R48(*) obligatory
X n with R48/route of exposure
concentration > 10%
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.
3.2. 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 preparation
Classification of the substance
T
X n
T with R48/route of exposure
concentration > 5%
0.5% < concentration < 5%
R48(*) obligatory
R48(*) obligatory
X n with R48/route of exposure
concentration > 5%
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
4.1. 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.
DANGEROUS SUBSTANCES AND PREPARATIONS
Table IV
Classification of the preparation
Classification of
C with R35
C with R 34
X i with R41
X i with R36,
the substance
R37, R38
C with R35
concentration >
5% <
5% (*)
1% <
10%
concentration <
concentration <
R35 obligatory
10%
5%
R34 obligatory
R36/38
obligatory
C with R 34
concentration >
10% (*)
5% <
10%
concentration <
R34 obligatory
10%
R36/38
obligatory
X i with R41
concentration >
5% <
10%
concentration <
R41 obligatory
10%
R36 obligatory
X i with R36, R37,
concentration >
20%
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.
Note: 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 of the gaseous preparation
Classification of
C with R35
C with R 34
X i with R41
X i with R36,
the substance (gas)
R37, R38
C with R35
concentration >
0.2% <
0.2% (*)
0.02% <
1%
concentration <
concentration <
R35 obligatory
1%
0.2%
R34 obligatory
R36/38
obligatory
C with R 34
concentration >
5% (*)
0.5% <
5%
concentration <
R34 obligatory
5%
R36/38
obligatory
X i with R41
concentration >
0.5% <
5%
concentration <
R41 obligatory
5%
R36 obligatory
X i with R36, R37,
concentration >
5%
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.
Note: 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
5.1. 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 preparation
Classification of the substance
Sensitising with R42
Sensitising with R43
Sensitising with R42
concentration > 1%
R42 obligatory
Sensitising with R43
concentration > 1%
R43 obligatory
5.2. 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 phrse 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.
DANGEROUS SUBSTANCES AND PREPARATIONS
Table V A
Classification of the gaseous preparation
Classification of the substance
(gas)
Sensitising with R42
Sensitising with R43
Sensitising with R42
concentration > 0.2%
R42 obligatory
Sensitising with R43
concentration > 0.2%
R43 obligatory
6. Carcinogenic/mutagenic/toxic effects for reproduction
6.1. Non-gaseous preparations
For substances which produce such effects, the concentration limits laid
down in Tatble 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
Catrcinogenic category 3
X n ; R40
Mutagcnic 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 preparation
Classification of the substance
Categories 1 and 2
Category 3
c arcinog enic su bstanc es of
concentration > 0.1%
category 1 or 2 with R45 or
carcinogenic
R45, R49 obligatory as
appropriate
c arcinog enic su bstanc es of
concentration > 1%
category 3 with R40
carcinogenic
R40 obligatory (unless
already assigned R45(*))
mutagenic substances of
concentration > 0.1%
category 1 or 2 with R46
mutagenic
R46 obligatory
mutagenic substances of
concentration > 1%
category 3 with R68
mutagenic
R68 obligatory (unless
already assigned R46)
substances 'toxic for
concentration > 0.5%
reproduction' of category 1 or
toxic for reproduction
2 with R60 (fertility)
(fertility)
R60 obligatory
substances 'toxic for
concentration > 5%
reproduction' of category 3
toxic for reproduction
with R62 (fertility)
(fertility)
R62 obligatory (unless
already assigned R60)
substances 'toxic for
concentration > 0.5%
reproduction' of category 1 or
toxic for reproduction
2 with R61 (development)
(development)
R61 obligatory
substances 'toxic for
concentration > 5%
reproduction' of category 3
toxic for reproduction
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.
6.2. 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
Catrcinogenic category 3
X n ; R40
Mutagcnic 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 preparation
Classification of the substance
Categories 1 and 2
Category 3
carcino gen ic substan ces of
concentration > 0.1%
category 1 or 2 with R45 or
carcinogenic
R45, R49 obligatory as
appropriate
carcino gen ic substan ces of
concentration > 1%
category 3 with R40
carcinogenic
R40 obligatory (unless
already assigned R45(*))
mutagenic substances of
concentration > 0.1%
category 1 or 2 with R46
mutagenic
R46 obligatory
mutagenic substances of
concentration > 1%
category 3 with R68
mutagenic
R68 obligatory (unless
already assigned R46)
substances 'toxic for
concentration > 0.2%
reproduction' of category 1 or
toxic for reproduction
2 with R60 (fertility)
(fertility)
R60 obligatory
substances 'toxic for
concentration > 1%
reproduction' of category 3
toxic for reproduction
with R62 (fertility)
(fertility)
R62 obligatory (unless
already assigned R60)
substances 'toxic for
concentration > 0.2%
reproduction' of category 1 or
toxic for reproduction
2 with R61 (development)
(development)
R61 obligatory
substances 'toxic for
concentration > 1%
reproduction' of category 3
toxic for reproduction
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 Directive 1999/45/EC of the 31st May, 1991 as
amended by Commission Directive 2001/60/EC of the 7th August,
2001.
L.N. 267 of 2009.
Methods for the evaluation of the environmental
hazards of preparations in accordance with
regulation 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 regulation 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 regulation 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures 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
1. 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)
1.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
1.2. 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 1.1.1(a) or (b) if
Σ ( P L N,R50-53
) > 1
N,R50-53
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,
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
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 1.1 above;
2.1 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
2.2. 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 1.2.(a) or (b) if
Σ ( P L N,R51-53
L N,R51-53 )
P N,R51-53
N,R50-53
+
> 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,
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
environm ent to which is assig ned phrases R50-5 3 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 1.1 or 1.2 above;
3.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
3.2. 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 1.3.1(a)
Σ ( P L N,R50-53
) > 1
P N,R51-53
P R52-53
+
+
L R52-53
L R52-53
R52-53
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 1.1 above
4.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
4.2. preparations containing more than one substance classified as dangerous for
th e en v ir o nm en t an d to wh ich is as sig n ed ph r ase R5 0 in lo wer in d iv id ual
concentrations than the limits specified under 1.4.1(a) or (b) if
Σ ( P L N,R50
) > 1
N,R50
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.
4.3. 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 1.4.1 or 1.4.2 and containing one or more than one substance classified
as dangerous for the environment and to which is assigned phrases R50-53 if
Σ (
) > 1
P N,R50
P N,R50-53
+
L N,R50
L N,R50
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
5. and assigned the risk phrase R52 unless the preparation is already classified
according to 1.1, 1.2, 1.3, or 1.4 above
5.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
5.2. preparations containing more than one substance classified as dangerous for
th e en vi ro n m ent an d to wh ich is ass ig ned p h ras e R 52 i n low er in di vid u al
concentrations than the limits specified under 1.5.1(a) or (b) if
Σ ( P L R52
) > 1
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 1.1, 1.2 or 1.3 above
6.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
6.2. preparations containing more than one substance classified as dangerous for
th e en vi ro n m ent an d to wh ich is ass ig ned p h ras e R 53 i n low er in di vid u al
concentrations than the limits specified under 1.6.1(a) or (b) if
Σ ( P L R53
) > 1
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;
6.3. 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 1.6.2 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
Σ ( P L R53
) > 1
P
P
P R52-53
+ N,R50-53 + N,R51-53 +
L R53
L R53
L R53
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
1. Conventional method for the evaluation of preparations dangerous for the
ozone layer
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 phrase R59;
1.1. 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 Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of
16 December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and
packaging of substances and mixtures or appear in it without
concentration limits;
(2)
TERRESTRIAL ENVIRONMENT
1. 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-temp adverse effects in the environment.
PART B
Concentration limits to be used for the evaluation of environmental hazards
1. 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 preparation
Classification of the
substance
N,R50-53
N,R51-53
R52-53
N,R50-53
See Table 1b
See Table 1b
See Table 1b
N,R51-53
C n > 25%
2.5% < C n < 25%
C n > 25%
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
LC 50 or EC 50 value
Classification of the preparation
("L(E)C 50 ") of substance
N,R50-53
N,R51-53
R52-53
classified as N,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 subdstances 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
Classification of the preparation
LC 50 or EC 50 value ("L(E)C 50 ") of substance
classified as N,R50-53 (mg/l)
N,R50-53
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 subdstances 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%
N,R50-53
C n > 25%
N,R51-53
C n > 25%
R52-53
C n > 25%
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
N with R59
C > 0.1%
PART C
Test methods for the evaluation of the hazards for the aquatic environment
Normally, th e classification of a preparation is m ade 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
DANGEROUS SUBSTANCES AND PREPARATIONS
Dircctive 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. These regulations shall apply to
-
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, 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, the regulations on
classification, packaging, labelling and safety datasheets of these
regulations shall apply to biocide products.
DANGEROUS SUBSTANCES AND PREPARATIONS
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;
(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;
(d) foodstuffs;
(e) animal feedingstuffs;
(f)
preparations containing radioactive substances as
defined by the Nuclear Safety and Radiation
Protection Regulations;
(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
regulation 11 and under the conditions laid down in regulation 7, 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.
Identification of the substance
No
Concentration limit
CAS Re No
Name
Einecs No
67-56-1
Methanol
2006596
> 3%
75-09-2
Dichloromethane
2008389
> 1%
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 regulation 11 and under the
conditions laid down in regulations 6 and 7, 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,
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
DANGEROUS SUBSTANCES AND PREPARATIONS
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.
Amended by
L.N. 267 of 2009.
Special provisions concerning the labelling
of certain preparations
A.
For preparations classified as dangerous within the meaning of regulations
8, 9 and 10
1. Preparations sold to the general public
1.1. The labels on packages 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.
1.2. 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 package label 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
cumulutive 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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the
European Parliament and of the Council of 16 December 2008 on the classification,
labelling and packaging of substances and mixtures.
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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on the classification, labelling
and packaging of substances and mixtures.
B.
For preparations irrespective of their classification within the meaning of
regulations 8, 9 and 10
1. Preparations containing lead
1.1. 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
2.1. 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."
4. Preparations containing epoxy constituents with an average molecular
weight < 700
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 abovementioned 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 of the preparation must bear the
inscrip tio n "C aution - this preparation contains a su bstan ce no t 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 Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the
European Parliament and of the Council of 16 December 2008 on the classification,
labelling and packaging of substances and mixtures 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
55ºC and contain a halogenated hydrocarbon and more than 5% flammable or highly
flammable substances, the label on the packag in g m ust bear the f ollowing
inscription as appropriate
"Can become highly flammable in use" or "Can become flammable in use".
11. Preparatious 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 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
For preparations not classified within the meaning of regulations 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 regulation 17.3
must bear the following inscription
DANGEROUS SUBSTANCES AND PREPARATIONS
"Safety data sheet available for professional user on request".
Amended by
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 Part 3 of Annex VI to Regulation (EC)
No. 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification,
labelling and packaging of substances and mixtures,
-
are listed in ELINCS in accordance with the
Dangerous Substances (Notification) Regulations,
-
are classified and labelled provisionally by the person
responsible for the placing on the market in
accordance
with
the
Dangerous
Substances
(Notification) Regulations,
-
are classified and labelled in accordance with the
Dangerous Substances (Notification) Regulations, and
are not yet included in ELINCS,
-
are covered by the
Dangerous
Substances
(Notification) Regulations,
-
are classified and labelled in accordance with the
Dangerous Substances (Notification) Regulations,
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 Part 3 of Annex VI to Regulation (EC) No 1272/
2 0 08 o f t he E u r o p ean Par l iam en t an d o f t he Co u n cil of 16
December 2008 on the classification, labelling and packaging of
substances and mixtures, or in Part B of the Second Schedule or in
Part B of the Third Schedule, unless otherwise specified in the Fifth
Schedule.
Category of danger of the substance
Concentration to take 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
L.N. 309 of 2007;
Confidentiality for the chemical identity
L.N. 267 of 2009;
L.N. 337 of 2013.
of a substance
PART A
Information to be communicated in the request for confidentiality
Introductory notes
A.
Regulation 18 indicates the conditions in which the person responsible for
placing a preparation on the market may avail himself of the confidentiality.
B.
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.
C.
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.
D.
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 regulation 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 designation
international nomenclature and
classification (Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the
European Parliament and of the Council
of 16 December 2008 on the
classification, labelling and packaging of
substances and mixtures or provisional
classification)
(a)
(b)
(c)
N.B: 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 (probabiliy - 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 namc(s) used in the different
Member States
Belgium
Bulgaria
Czech Republic
Denmark
Germany
Estonia
Ireland
Greece
Spain
France
Croatia
Italy
Cyprus
Latvia
Lithuania
Luxembourg
Hungary
Malta
Netherlands
Austria
DANGEROUS SUBSTANCES AND PREPARATIONS
Poland
Portugal
Romania
Slovenia
Slovakia
Finland
Sweden
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 regulation 7.
8. Labelling of the preparation(s) according to regulation 11.
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 Part 3
of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of
the Council of 16 December 2008 on the classification, labelling and packaging of
substances and mixtures.
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 Part 3 of Annex VI to Regulation (EC) No
1272/2008 of the European Parliament and of the Council of 16
December 2008 on the classification, labelling and packaging of
substances and mixtures 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 Part 3 of
Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on the classification, labelling and packaging of
substances and mixtures (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 abd 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
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
Hydrogen compounds
Hydrides
Helium compounds
Lithium compounds
Beryllium compounds
Boron compounds
- Boranes
- Borates
Carbon compounds
- Carbantates
- 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
DANGEROUS SUBSTANCES AND PREPARATIONS
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
Sodium compounds
Magnesium compounds
- Organometallic magnesium derivatives
Aluminium compounds
- Organometallic aluminium derivatives
Silicon compounds
- Silicones
- Silicates
Phosphorus compounds
- 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
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
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
Tellurium compounds
Iodine compounds
Xenon compounds
Caesium compounds
Barium compounds
Lanthanum compounds
Cerium compounds
Praseodymium compounds
Neodymium compounds
Promethium compounds
Samarium compounds
Europium compounds
DANGEROUS SUBSTANCES AND PREPARATIONS
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
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
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
Californium compounds
Einsteinium compounds
Fermium compounds
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
DANGEROUS SUBSTANCES AND PREPARATIONS
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
- 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 (*)
- 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
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
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
- Pyretbrinoids
- 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
- Coal liquids, liquid solvent extraction
DANGEROUS SUBSTANCES AND PREPARATIONS
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
- 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
- Dis tilla te s (co al), so lven t ex tractio n, hy d rocra ck ed
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
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
- 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
- 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
DANGEROUS SUBSTANCES AND PREPARATIONS
Family No
Part 3 of Annex VI
to Regulation (EC)
No 1272/2008 of the
European
Parliament and of
the Council of 16
Families & Sub-families
December 2008 on
the classification,
labelling and
packaging of
substances and
mixtures
- Unrefined or mildly refined base oil
- Base oil - unspecified
- Distillate aromatic extract
- Distillate aromatic extract (treated)
- Foots oil
- Slack wax
- Petrolatum
Various substances
- Do no t us e this fa mily. In ste ad, u se th e fam ilie s o r
subfamilies 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
4.1. 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: glycotethers
generic name: glycolether
-
methacrylate
family 607: organic acids and derivatives
sub-family: acrylates
generic name: acrylate
4.2 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
DANGEROUS SUBSTANCES AND PREPARATIONS
-
sodium hydrosulphite
family 016: sulphur compounds
generic name: inorganic sulphur compound
(The examples cited are substances taken from Part 3 of Annex VI to Regulation
(EC) No 1272/2008 of the European Parliament and of the Council of 16 December
2008 on the classification, labelling and packaging of substances and mixtures 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 regulation 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 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
T he deter mination of the exp lo sive, ox id ising, 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 Aerosol
Dispensers Regulations.
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.
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.
8.5. The hazards deriving from the physico-chemical properties
o f a p r ep a r a t io n co v er ed b y th e P l an t P r o te c ti o n P r o d u c t s
R eg ul atio n s, o r eq u iv alen t p r o vi sio n s sh all be ass ess ed b y
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.
1. The health hazards of a preparation shall be assessed by
one 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 67/548/EEC, 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.
9.2. Without prejudice to the requirements of the Plant
Protection Products Regulations, or equivalent provisions, only
w h e r e i t c a n b e s c i e n t i f ic a l l y d em o n s t r a t e d b y t h e p er s o n
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 9.1.(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, 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, 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
Permitted variation in initial
range of 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
regulation 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
assessed by one or more of the following procedures
(a) by a conventional method described in the Third
Schedule;
(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
Products Regulations. Without prejudice to the testing
requirements set out in the Plant Protection Products
Regulations, the conditions for application of the test
methods are described in Part C of the Third Schedule.
10.2. When an ecotoxicological property is established by one of
the methods outlined in regulation 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 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 regulation 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 regulation 10.1.(b), a new evaluation of
environmental hazard either by the method outlined in regulation
8.1.(a) or that outlined in regulation 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
Permitted variation in initial
range of the constituent concentration of the constituent
< 2.5%
± 30 %
> 2.5 < 10%
± 20%
> 10 < 25%
± 10%
> 25 < 100%
± 5%
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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
regulation 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 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
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the data used for the classification and labelling of the
preparation,
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any pertinent information relating to packaging
requirements in accordance with regulation 12.1.3,
including the test certificate issued in accordance with
Part A of Annex IX to Directive 67/548/EEC,
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the data used for establishing the safety data sheet, in
accordance with regulation 15.
1. Preparations within the meaning of regulation 4.2. and
preparations covered by the Fourth Schedule pursuant to regulation
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,
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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,
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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 regulation 4.2. and preparations covered by the Fourth Schedule
pursuant to regulation 4.3. offered or sold to the general public
must not have
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either a shape and, or graphic decoration likely to
attract or arouse the active curiosity of children or to
mislead consumers, or
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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 must
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be fitted with child-resistant fastenings, and, or
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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 regulations 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 regulation 4.2. cannot
be placed on the market unless the labelling on their packaging
satisfies all the requirements of regulation 13.2. and the specific
provisions of Part A and B of the Fifth Schedule.
Preparations within the meaning of regulation 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
regulations 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, 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.
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
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for preparations classified as T+, T, Xn in accordance
with regulation 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
Part 3 of Annex VI to Regulation (EC) No 1272/2008
of the European Parliament and of the Council of 16
December 2008 on the classification, labelling and
packaging of substances and mixtures or, failing that,
Part B of the Second Schedule have to be taken into
consideration;
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for preparations classified C in accordance with
regulation 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
have to be taken into consideration;
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the name of the substances which have given rise to
the classification of the preparation in one or more of
the following hazard categories
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carcinogen category 1, 2 or 3,
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mutagen category 1, 2 or 3,
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toxic for reproduction category 1, 2 or 3,
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very toxic, toxic or harmful due to non-lethal
effects after a single exposure,
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toxic or harmful due to severe effects after
repeated or prolonged exposure,
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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.
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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
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explosive,
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oxidising,
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extremely flammable,
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highly flammable,
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flammable,
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irritant,
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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 regulation 13.2.3.
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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.
Where more that one danger symbol must be assigned to a
preparation the obligation to apply the symbol
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T shall make the symbols C and Xn optional unless
otherwise specified in Part 3 of Annex VI to
Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008
on the classification, labelling and packaging of
substances and mixtures,
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C shall make the symbol Xi optional,
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E shall make the symbol F and O optional,
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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.
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.
T h e s t a n d a r d p h r a s e s " e x t r e m e l y f l am m a b l e " o r "h i g h l y
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.
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 regulation 10, by way of derogation from regulations
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
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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,
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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 regulation 43(3) of the Plant
Protection Products Regulations, indications such as "non-toxic",
"n o n - h ar m f u l ", "n o n - p o l lu t in g ", "e co l o g i cal " o r an y o t h er
statement indicating that the preparation is not dangerous or likely
to lead to under-estimation 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 regulation 13 appear on
a label, that label shall be firmly affixed to one or more surfaces of
the 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 regulation 14.1.
14.3. The colour and presentation of the label - or, in the case of
regulation 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 regulation 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 regulations 13.2.1, 13.2.2,
13.2.3, 13.2.5 and 13.2.6; for preparations
classified according to regulation 10, the
provisions of regulation 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. Regulations 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
regulations 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,
regulations 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 regulation 13 to be
applied in some other appropriate manner on packages
which are either too small or otherwise unsuitable for
labelling in accordance with regulation 14.1 and 14.2;
(b) by way of derogation from regulations 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 regulations 13 and 14, for
preparations classified according to regulation 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 regulations 13 and 14
permit the packaging of dangerous preparations which
are not mentioned in paragraphs (b) or (c) 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 regulation 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 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.
17. (Deleted by: L.N. 221 of 2007)
1. Where the person responsible for placing the preparation
on the market can demonstrate that the disclosure on the label or
safety 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 regulation
13.2.3, or
-
harmful or harmful in combination with one or more of
the properties mentioned in the fourth indent of
regulation 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
r eq u ir em e nt s de em ed n eces s ar y to e ns u r e t ha t w or k er s ar e
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, 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.
DANGEROUS SUBSTANCES AND PREPARATIONS