The Dangerous Substances Regulations, 2008

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,344, 21 ta’ Novembru, 2008

L.N. 306 of 2008

PRODUCT SAFETY ACT

(CAP. 427)

The Dangerous Substances Regulations, 2008

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister of Finance, the Economy and

Investment has, on the advice of the Malta Standards Authority, made

the following regulations>-

The title of these regulations is the Dangerous Substances Title.

Regulations, 2008.

(1) These regulations concern the classification, packaging Applicability.

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 1

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>

(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)

OJ No L 196, 16.8.1967, 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 L 396, 30.12.2006, p. 850)<

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 market for the purposes of this

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 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 Testing and

regulations shall be conducted according to the requirements of Article assessment

properties of

13 of Regulation (EC) No 1907#2006 of the European Parliament and substances.

of the Council of 18 December 2006 concerning the Registration,

Evaluation, Authorisation and Restriction of Chemicals (REACH) and

establishing a European Chemicals Agency 2 and according to the

requirements set in Regulation (EC) No 440#2008 3 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 Classification.

properties according to the categories laid down in regulation 4(2) of

these regulations. 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 regulation 6(4) of these regulations

and in regulation 7 of the Dangerous Substances and Preparations

Regulations of 2007 (L.N. 10 of 2007).

OJ L 396, 30.12.2006, p. 1

OJ L142, 31.05.2008, p. 1

(2) The general principles of the classification and labelling

of substances and preparations shall be applied according to the criteria

in Annex VI of the Directive, save where contrary requirements for

dangerous preparations are specified in separate provisions.

(3) Annex I of the Directive contains the list of substances

classified in accordance with the principles outlined in regulations 6(1)

and 6(2), together with their harmonized classification and labelling.

(4) The dangerous substances listed in Annex I of the

Directive shall, where appropriate, be characterized by concentration

limits or any other parameter enabling an assessment to be made of the

health or environmental hazard of preparations containing the said

dangerous substances or substances containing other dangerous

substances as impurities.

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 of these regulations 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 dangerous

substances which appear in the EINECS but which have not yet been

introduced into Annex I of the Directive shall be obliged to 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

these substances according to the rules laid down in regulations 9 to 12

of these regulations and the criteria in Annex VI of the Directive.

(1) 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.

(2) The technical specifications relating to the devices

referred to in regulations 9(1)(e) and 9(1)(f) are to be found in points A

and B of Annex IX to the Directive.

(1) Dangerous substances cannot be placed on the market Labelling.

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 Annex I of the Directive. If the substance is not yet listed

in Annex I of the Directive, 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 Annex I of the Directive

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 Annex I 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 Annex I of the Directive. For

dangerous substances not yet appearing in Annex I of the Directive

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 Annex I of the

Directive. For dangerous substances not yet appearing in Annex I

of the Directive, 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 Annex I of the Directive, 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 10 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 regulation 11(1).

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

of regulation 11(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. Specific provisions regarding the

presentation and dimensions of this information laid down in Annex VI

of the Directive shall be observed.

(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 10(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 4(2) shall be prohibited

if no mention 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 has

been accepted as satisfying the requirements of these 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.

The Dangerous Substances (Notification) Regulations, 2001

are hereby revoked.

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