DANGEROUS SUBSTANCES REGULATIONS

SUBSIDIARY LEGISLATION 427.14

DANGEROUS SUBSTANCES REGULATIONS

21st November, 2008

LEGAL NOTICE 306 of 2008, as amended by Legal Notices 92 and 215

of 2009, and 335 of 2013.

The title of these regulations is the Dangerous Substances

Regulations.

(1) These regulations concern the classification, packaging

and labelling of substances dangerous to man or the environment,

where such substances are placed on the market.

(2) 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 Directive 65/65/EEC, as last amended by

Directive 87/21/EEC;

(b) cosmetic products defined by Directive 76/768/EEC,

as last amended by Directive 86/199/EEC;

(c) mixtures of substances which, in the form of waste, are

covered by Directives 75/442/EEC and 78/319/EEC;

(d) foodstuffs;

(e) animal feedingstuffs;

(f)

pesticides;

(g) radioactive substances as defined by Directive 80/836/

EEC;

(h) other substances or preparations for which a European

Community notification or approval procedures exist

and for which requirements are equivalent to those laid

down in these regulations.

(3)

In addition, these regulations shall not apply to

(a) the carriage of dangerous substances by rail, road,

inland waterway, sea or air; and

(b) substances in transit which are under customs

supervision, provided they do not undergo any

treatment or processing.

(1) In these regulations, the following definitions shall

apply, unless the context otherwise requires

"the Directive" shall mean Council Directive 67/548/EEC * on

the approximation of the laws, regulations and administrative

provisions relating to the classification, packaging and labelling of

dangerous substances, as amended by the following Directives

*OJ No L 196, 16.8.1967, p.1

(i)

Directive 71/144/EEC (OJ L 074, 29.3.1971, p.15)

(ii)

Directive 73/146/EEC (OJ L 167, 25.6.1973, p.1)

(iii)

Directive 75/409/EEC (OJ L 183, 14.7.1975, p.22)

(iv) Directive 76/907/EEC (OJ L 360, 30.12.1976, p.1)

(v) Directive 79/370/EEC (OJ L 088, 7.4.1979, p.1)

(vi) Directive 79/831/EEC (OJ L 259, 15.10.1979, p.10)

(vii) Directive 80/1189/EEC (OJ L 366, 31.12.1980, p.1)

(viii) Directive 81/957/EEC (OJ L 351, 7.12.1981, p.5)

(ix) Directive 82/232/EEC (OJ L 106, 21.4.1982, p.18)

(x) Directive 83/467/EEC (OJ L 257, 16.9.1983, p.1)

(xi) Directive 84/449/EEC (OJ L 251, 19.9.1984, p.1)

(xii) Directive 86/431/EEC (OJ L 247, 1.9.1986, p.1)

(xiii) Directive 87/432/EEC (OJ L 239, 21.8.1987, p.1)

(xiv) Directive 88/490/EEC (OJ L 259, 19.9.1988, p.1)

(xv) Directive 90/517/EEC (OJ L 287, 19.10.1990, p.37)

(xvi) Directive 91/410/EEC (OJ L 228, 17.8.1991, p.67)

(xvii) Directive 91/632/EEC (OJ L 338, 10.12.1991, p.23)

(xviii) Directive 92/32/EEC (OJ L 154, 5.6.1992, p.1)

(xix) Directive 92/37/EEC (OJ L 154, 5.6.1992, p.30)

(xx) Directive 93/21/EEC (OJ L 110, 4.5.1993, p.20)

(xxi) Directive 93/72/EEC (OJ L 258, 5.6.1992, p.30)

(xxii) Directive 92/37/EEC (OJ L 154, 16.10.1993, p.29)

(xxiii) Directive 93/101/EEC (OJ L 013, 15.1.1993, p.1)

(xxiv) Directive 92/105/EEC (OJ L 294, 30.11.1993, p.21)

(xxv) Directive 94/69/EC (OJ L 381, 31.12.1994, p.1)

(xxvi) Directive 96/54/EC (OJ L 248, 30.9.1996, p.1)

(xxvii) Directive 96/56/EC (OJ L 236, 18.9.1996, p.35)

(xxviii) Directive 97/69/EC (OJ L 343, 13.12.1997, p.19)

(xxix) Directive 98/73/EC (OJ L 325, 16.11.1998, p.1)

(xxx) Directive 98/98/EC (OJ L 335, 30.12.1998, p.1)

(xxxi) Directive 99/33/EC (OJ L 199, 30.7.1999, p.57)

(xxxii) Directive 2000/32/EC (OJ L 136, 8.6.2000, p.1)

(xxxiii) Directive 2000/33/EC (OJ L 136, 8.6.2000, p.90)

(xxxiv) Directive 2001/59/EC (OJ L 225, 21.8.2001, p.1)

(xxxv) Directive 2004/73/EC (OJ L 152, 29.04.2004, p. 1)

(xxxvi) Directive 2006/102/EC (OJ L 363, 20.12.2006)

(xxxvii) Directive 2006/121/EC (OJ L396, 30.12.2006,p. 850)

(xxxviii) Directive 2008/58/EC (OJ L246, 15.9.2008, p.1-191)

(xxxix) Article 55(11) of Regulation (EC) 1272/2008 (OJ L

353, 31.12.2008, p. 1–1355)

(xl) Directive 2013/21/EC (OJ L 158, 10.6.2013, p. 240-355)

Provided that references to Annexes VII A, VII B, VII C, VII D

and VIII in the Directive shall be construed as references to the

corresponding Annexes VI, VII, VIII, IX, X and XI of Regulation

(EC) No 1907/2006;

"EINECS" means the European Inventory of Existing

Commercial Substances. This inventory contains the definitive list

of all substances deemed to be on the Community market on 18

September 1981;

"placing on the market" means the making available to third

parties. Importation into the Community customs territory shall be

deemed to be placing on the mar ket for the purposes of the

Directive;

"preparations" means mixtures or solutions composed of two or

more substances;

"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.

(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) oxidizing 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

(i)

substances and preparations which may become

hot and finally catch fire in contact with air at

ambient temperature without any application of

energy, or

(ii) solid substances and preparations which may

readily catch fire after brief contact with a

source of ignition and which continue to burn or

to be consumed after removal of the source of

DANGEROUS SUBSTANCES

ignition, or

(iii) liquid substances and preparations having a very

low flash-point, or

(iv) substances and preparations which, in contact

with water or damp air, evolve highly 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 the skin

or mucous membrane, may cause inflammation;

(k) sensitizing substances and preparations: substances

and preparations which, if they are inhaled or if they

penetrate the skin, are capable of eliciting a reaction of

hypersensitization 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 present or

may present an immediate or delayed danger for one or

more components of the environment.

Tests on substances carried out within the framework of

these regulations shall be conducted according to the requirements

of Article 13 of Regulation (EC) No 1907/2006 of the European

Parliament and of the Council of 18 December 2006 concerning the

R eg is tr at io n , E v a lu ati o n, Au th o r is at io n an d R es tr i cti on of

Chemicals (REACH) and establishing a European Chemicals

Agency * and according to the requirements set in Regulation (EC)

No 440/2008 † of 30 May 2008 laying down test methods pursuant

to Regulation (EC) No 1907/2006.

(1) Substances shall be classified on the basis of their

intrinsic properties according to the categories laid down in

regulation 3(2). In the classification of substances, impurities shall

be taken into account as far as any concentration of the latter

exceeds the concentration limits specified in sub-regulation (4) and

in regulation 7 of the Dangerous Substances and Preparations

Regulations.

(2) The general principles of the classification and labelling of

substances and preparations shall be applied according to the

cr iter ia i n An n ex V I o f th e Dir ective, s ave wh er e con tr ar y

requirements for dangerous preparations are specified in separate

provisions.

(3) Where an entry containing the harmonized classification

and labelling for a particular substance has been included 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

classification, labelling and packaging of substances and mixtures,

the substance shall be classified in accordance with that entry and

sub-regulations (1) and (2) shall not apply to the danger categories

covered by that entry.

Substances cannot be placed on the market on their own or

in preparations unless they have been packaged and labelled in

accordance with regulations 9 to 12 and with the criteria in Annex

VI of the Directive, and, for registered substances, in accordance

with the information obtained through the application of Articles

12 and 13 of Regulation (EC) No 1907/2006, save in the case of

preparations where provisions exist in other Directives.

Manufacturers, distributors and importers of substances

which appear in the EINECS but for which no entry has been

included in Part 3 of Annex VI to Regulation (EC) No 1272/2008

shall carry out an investigation to make themselves aware of the

relevant and accessible data which exist concerning the properties

of such substances. On the basis of this information, they shall

package and provisionally label dangerous substances according to

the rules laid down in Articles 22 to 25 of the Directive Directive

and the criteria in Annex VI to the Directive.

*OJ L 396, 30.12.2006, p. 1

†OJ L 142, 31.05.2008, p. 1

DANGEROUS SUBSTANCES

Dangerous substances cannot be placed on the market

unless their packaging satisfies the following requirements

(a) it shall be so designed and constructed that its contents

cannot escape; this requirement shall not apply where

special safety devices are prescribed;

(b) the materials constituting the packaging and fastenings

must not be susceptible to adverse attack by the

contents, or liable to form dangerous compounds with

the contents;

(c) 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;

(d) containers fitted with replaceable fastening devices

shall be so designed that the packaging can be

refastened repeatedly without the contents escaping;

(e) every container of whatever capacity, containing

substances sold or made available to the general public

and labelled "very toxic", "toxic" or "corrosive", as

defined in these regulations, must have a child-

resistant fastening and a tactile warning of danger;

(f)

every container, of whatever capacity, containing

substances sold or made available to the general public

and labelled "harmful", "extremely flammable" or

"highly flammable" as defined in these regulations

must bear a tactile warning of danger.

(1) Dangerous substances cannot be placed on the market

unless the labelling on their packaging satisfies the following

requirements.

(2) Every package shall show clearly and indelibly the

following

(a) the name of the substance under one of the

designations given in Part 3 of Annex VI to Regulation

(EC) No. 1272/2008. If the substance is not yet listed

in Part 3 of Annex VI to Regulation (EC) No. 1272/

2008, the name shall be given using an internationally

recognized designation;

(b) the name and full address including the telephone

number of the person established in the European

Community who is responsible for placing the

substance on the market whether it be the

manufacturer, the importer or the distributor;

(c) danger symbols, when laid down, and indication of the

danger involved in the use of the substance. The

design of the danger symbols and the wording of the

indications of danger shall comply with those laid

down in Annex II of the Directive. The symbol shall

be printed in black on an orange-yellow background.

The danger symbols and indications of danger to be

used for each substance shall be those indicated in

Annex I of the directive. For dangerous substances not

yet appearing in Part 3 of Annex VI to Regulation

(EC) No. 1272/2008 the danger symbols and

indications of danger shall be assigned according to

the rules laid down in Annex VI of the Directive.

When more than one danger symbol is assigned to a

substance

(i)

the obligation to indicate the symbol T makes

the symbols X and C optional, unless Part 3 of

Annex VI to Regulation (EC) No. 1272/2008

provides otherwise,

(ii) the obligation to indicate the symbol C makes

the symbol X optional,

(iii) the obligation to indicate the symbol E makes

the symbol F and O optional;

(d) standard phrases (R-phrases) indicating the special

risks arising from the dangers involved in using the

substance. The wording of those R-phrases shall

comply with that laid down in Annex III of the

Directive. The R-phrases to be used for each substance

shall be as indicated in Part 3 of Annex VI to

Regulation (EC) No. 1272/2008. For dangerous

substances not yet appearing in Part 3 of Annex VI to

Regulation (EC) No. 1272/2008 the R-phrases to be

used shall be assigned according to the rules laid down

in Annex VI of the Directive;

(e) standard phrases relating to the safe use of the

substance (S-phrases). The wording of these S-phrases

shall comply with that laid down in Annex IV of the

Directive. The S-phrases to be used for each substance

shall be as indicated in Part 3 of Annex VI to

Regulation (EC) No. 1272/2008. For dangerous

substances not yet appearing in Part 3 of Annex VI to

Regulation (EC) No. 1272/2008, the S-phrase to be

used shall be assigned according to the rules laid down

in Annex VI of the Directive;

(f)

the EC number, when allocated. The EEC number shall

be obtained from the EINECS or from the list referred

to in Article 21(1) of the Directive. In addition, as

regards substances appearing in Part 3 of Annex VI to

Regulation (EC) No. 1272/2008, the label shall also

include the words "EC label".

(3) In the case of irritant, highly flammable, flammable and

oxidizing substances, an indication of R-phrases and S-phrases

need not be given where the package does not contain more than

125 ml. This shall also apply in the case of the same volume of

harmful substances not retailed to the general public.

(4) Indications such as "non-toxic", "non-harmful" or any other

similar indications must not appear on the label or packaging of

substances subject to these regulations.

(1) Where the particulars required by regulation 9 appear

on a label, that label shall be firmly affixed to one or more surfaces

of the packaging so that these particulars can be read horizontally

when the package is set down normally. The dimensions of the

label shall be as follows

Capacity of the package

Dimension

(in millimetres)

not exceeding 3 litres

at least 52 _ 74

greater than 3 litres but not exceeding 50 litres

at least 74 _ 105

greater than 50 litres but not exceeding 500 litres

at least 105 _ 148

greater than 500 litres

at least 148 _ 210

Each symbol shall cover at least one-tenth of the surface area of

the label but not be less than 1 cm 2 . The entire surface of the label

shall adhere to the package immediately containing the substance.

These dimensions are intended solely for provisions of the

information required by these regulations and if necessary of any

supplementary health or safety indications.

(2) A label is not required where the particulars are clearly

shown on the package itself, as specified in sub-regulation (1).

(3) The colour and presentation of the label - or, in the case of

sub-regulation (2), of the package - shall be such that the danger

symbol and its background stand out clearly.

(4) The information required on the label under regulation 11

shall stand out clearly from its background and shall be of such size

and spacing as to be easily read.

(5) Dangerous substances may only be placed on the market if

they are labelled in at least one of the official languages of Malta.

(6) For the purpose 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 substances and the inner package or

packages are labelled in accordance with these

regulations;

(b) in the case of a single package

(i)

if such a package is labelled in accordance with

international rules on the transport of dangerous

substances and with regulations 9(2)(a), (b), (d),

(e) and (f), and

(ii) where appropriate, for particular types of

packaging such as mobile gas cylinders, in

accordance with the specific requirements

referred to in Annex VI of the Directive.

Where dangerous substances do not leave the territory of Malta,

labelling which complies with national rules instead of with

international rules on the transport of dangerous substances may be

permitted.

Regulations 9, 10 and 11 shall not apply to the provisions

governing munitions and explosives placed on the market with a

view to producing a practical effect by explosion or a pyrotechnic

effect.

Any advertisement for a substance which belongs to one or

more of the categories referred to in regulation 3(2) shall be

prohibited if no m ention is made therein of the category or

categories concerned.

Substances which comply with the requirements of these

regulations, on grounds relating to notification, classification,

packaging or labelling within the meaning of the Directive, may

not be prohibited, restricted or impeded from being placed on the

market.

Where, in the light of new information, the competent

authority has justifiable reasons to consider that a substance, which

h as b e e n a cc e p t e d a s s a ti s f y i n g t h e r e q u i r e m e n t s o f t h e s e

regulations, nevertheless constitutes a danger for man or the

environment, by reason of classification, packaging or labelling

which is no longer appropriate, it may temporarily reclassify or, if

necessary, prohibit the placing on the market of that substance or

subject it to special conditions.

Regulations 8 to 11 shall not apply to substances from the

1st of December, 2010.