Regulations, 2003

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,503, 14 ta’ Novembru, 2003

L.N. 346 of 2003

PRODUCT SAFETY ACT, 2001

(ACT NO. V OF 2001)

Dangerous Substances and Preparations (Restrictions)

Regulations, 2003

IN exercise of the powers conferred by article 38 of the Product

Safety Act, the Minister of Finance and Economic Affairs, on the advice

of the Malta Standards Authority, has made the following regulations

The title of these regulations is the Dangerous Substances and Citation.

Preparations (Restrictions) Regulations, 2003.

Restrictions on Dangerous Substances and Preparations

Designation of the substance, of the

Conditions of restriction

groups of substances or of the

preparation

1. - Polychlorinated biphenyls (PCB)

May not be used.

except mono- and dichlorinated

biphenyls

- Polychlorinated terphenyls (PCTs)

- Preparations, including waste oils,

with a PCB or PCT content higher

than 0.005 % by weight

2. Chloro-1-ethylene (monomer vinyl

May not be used as aerosol propellant

chloride)

for any use whatsoever.

3. Liquid substances or preparations,

May not be used in

which are regarded as dangerous

according to the definitions in Article

-

ornamental objects intended to

2(2) and the criteria in Annex VI, Part

produce light or colour effects by

II.D to Council Directive 67/548/EEC

means of different phases, for

of 27 June 1967 on the approximation

example in ornamental lamps and

of laws, regulations and administrative

ashtrays.

provisions relating to the classification,

-

tricks, jokes.

packaging and labelling of dangerous

-

games for one or more participants,

substances ( 1 ), as adapted to technical

or any object intended to be used as

progress by Commission Directives

such, even with ornamental aspects.

93/21/EEC ( 2 ) and 96/54/EC ( 3 )

2. Without prejudice to the above,

substances and preparations which

- present an aspiration hazard and are

labelled with R65, and

- can be used as fuel in decorative

lamps, and

- are placed on the market in

packaging of a capacity of 15 litres

or less,

may not contain a colouring agent,

unless required for fiscal reasons, or

perfume or both.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of substances and

preparations covered by paragraph 2,

OJ No L 196, 16.8.1967, p.1

OJ No L 110, 4.5.1993, p.20

OJ L 248, 30.9.1996, p.1

preparation

where intended for use in lamps, must

be marked legibly and indelibly as

follows

“Keep lamps filled with this liquid out

of the reach of children.”

4. Tris (2,3 dibromopropyl) phosphate,

May not be used in textile articles, such

CAS No (Chemical Abstract Service

as garments, undergarments and linen,

Number) 126-72-7

intended to come into contact with the

skin.

5. Benzene

Not permitted in toys or parts of toys as

CAS No. (Chemical Abstract Service

placed in the market where the

Number) 71-43-2

concentration of benzene in the free

state is in excess of 5 mg/kg of the

weight of the toy or part of toy.

May not be used in concentrations

equal to, or greater than, 0.1 % by mass

in substances or preparations placed on

the market.

However, this provision shall not apply

to

(a) motor fuels which are covered by

Directive 85/210/EEC;

(b) substances and preparations for use

in industrial processes not allowing

for the emission of benzene in

quantities in excess of those laid

down in existing legislation;

(c) waste covered by Directives

75/442/EEC ( 4 ) and 78/319/EEC ( 5 )

6. Asbestos fibres

6.1

Crocidolite, CAS No 12001-28-4

6.1. The placing on the market and use

Amosite, CAS No 12172-73-5

of these fibres and of products

Anthophyllite asbestos, CAS No

containing

these

fibres

added

77536-67-5

intentionally shall be prohibited.

Actinolite asbestos, CAS No 77536-66-

Tremolite asbestos, CAS No 77536-68-

6.2. As from 1 st January 2005, the

6.2

Chrysotile, CAS No 12001-29-5

placing on the market and use of this

fibre and of products containing this

OJ No L 194, 25.7.1975, p.39

OJ No L 84, 31.3.1978, p.43

preparation

fibre added intentionally shall be

prohibited with the exception of

diaphragms for existing electrolysis

installations until they reach the end of

their service life, or until suitable

asbestos-free

substitutes

become

available, whichever is the sooner.

The use of products containing asbestos

fibres referred to in points 6.1 and 6.2

which were already installed and/or in

service before 1 st January 2005 shall

continue to be authorised until they are

disposed of or reach the end of their

service life.

The provisions of points 6.1 and 6.2 of

the First Schedule of the Dangerous

Substances

and

Preparations

(Restrictions) Regulations 2001 (L.N.

152 of 2001) shall continue to apply

between 1 st July 2002 and 1 st January

2005. Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

placing on the market and use of these

fibres and of products containing these

fibres, as authorised according to the

preceeding derogations, may be

permitted only if the products bear a

label in accordance with the provisions

of the Schedule of the Asbestos

Products (Labelling) Regulations, 2001

(L.N. 60 of 2001).

1 These regulations shall apply to the marketing and use of the Applicability.

dangerous substances and preparations listed in the Schedules hereto.

2.2

These regulations shall not apply to:-

(a) the carriage of dangerous substances and preparations

by rail, road, inland waterway, sea or air;

(b)

dangerous substances and preparations intended for

export;

(c) substances and preparations in transit and subject to

customs inspection, provided that they undergo no processing.

1 For the purposes of this Order, the following definitions shall Definitions.

apply, unless the context otherwise requires:-

‘substances’ means chemical elements and their compounds

as they occur in the natural state or as produced by industry;

‘preparations’ means mixtures or solutions composed of two

or more substances.

1 The dangerous substances and preparations listed in the Restrictions on

marketing.

Schedules to these regulations may only be placed on the market or

used subject to the conditions specified therein.

4.2 The provisions of sub-regulation 4.1 shall not apply to

marketing or use for Research and Development or analysis purposes.

1 The Foodstuffs, Chemicals and Cosmetics Directorate of the

Malta standards Authority shall make available to the general public an

updated copy of the Appendix to Council Directive 76/769/EEC

containing substances classified as carcinogenic, mutagenic or toxi to

reproduction of category 1 or 2 as referred to in points 29, 30 and 31 of

the First Schedule to these regulations.

1 The Dangerious Substances and Preparations (Restrictions)

Regulations, 2002 are hereby repealed insofar as certain provisions

thereof and of the Dangerious Substances adn Preparations (Restrictions)

Regulations, 2001 shall continue to apply as indicated in the First

Schedule to these regulations.

di-isononyl phthalate (DINP)

Not permitted in toys and childcare

CAS No.: 28553-12-0

articles as placed on the market and

Einecs No.: 249-079-5

intended to be placed in the mouth by

children of less than three years of age,

di(2-ethylhexyl) phthalate (DEHP)

and made of, or in part made of, soft

CAS No.: 117-81-7

PVC, where the concentration of these

Einecs No.: 204-211-0

substances is in excess of 0.1 % by

weight.

di-n-octyl phthalate (DNOP)

Designation of the substance, of the

Conditions of restriction

groups of substances or of the

preparation

CAS No.: 117-84-0

For the purposes of this point, the

Einecs No.: 204-214-7

following definitions shall apply

di-iso-decyl phthalate (DIDP)

‘toy’ shall mean any product designed

CAS No.: 26761-40-0

or clearly intended for use in play by

Einecs No.: 247-977-1

children,

butyl benzyl phthalate (BBP)

‘childcare article’ shall mean any

CAS No.: 85-68-7

product intended to facilitate sleep,

Einecs No.: 201-622-7

relaxation, the feeding of children, or

sucking on the part of children.

dibutyl phthalate (DBP)

CAS No.: 84-74-2

Einecs No.: 201-557-4

Tris-aziridinyl)-phosphinoxide

May not be used in textile articles, such

CAS No 5455-55-1

as garments, undergarments and linen,

intended to come into contact with the

skin.

Polybromobiphenyls (PBB)

May not be used in textile articles, such

CAS No 59536-65-1

as garments, undergarments and linen,

intended to come into contact with the

skin.

Soap bark powder (Quillaja saponaria) May not be used in jokes and hoaxes or

and its derivatives containing saponines in objects intended to be used as such,

for instance as a constituent of sneezing

Powder of the roots of Helleborus

powder and stink bombs

viridis and Helleborus niger

Powder of the roots of Veratrum album

and Veratrum nigrum

Benzidine and/or its derivatives

o-nitrobenzaldehyde

CAS No 552-89-6

Wood powder

Ammonium sulphide and ammonium

May not be used in jokes and hoaxes or

hydrogen sulphide

in objects intended to be used as such,

CAS No 12135-76-1

for instance as a constituent of sneezing

CAS No 12124-99-1

powder and stink bombs

Ammonium polysulphide

CAS No 12259-92-6

Volatile esters of bromoacetic acids

May not be used in jokes and hoaxes or

in objects intended to be used as such,

Methyl bromoacetate

for instance as a constituent of sneezing

preparation

CAS No 96-32-2

powder and stink bombs .

Ethyl bromoacetate

CAS No 105-36-2

Propyl bromoacetate

Butyl bromoacetate

2-naphthylamine

May not be used in concentrations

CAS No 91-59-8 and its salts

equal to or greater than 0.1 % by

weight in substances and preparations

placed on the market.

However, this provision shall not apply

to waste containing one or more of

these substances and covered by

Directives 75/442/EEC and

78/319/EEC.

Such substances and preparations may

not be sold to the general public.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of such preparations shall be

legibly and indelibly marked as

follows

“Restricted to professional users”.

Benzidine

May not be used in concentrations

CAS No 92-87-5 and its salts

equal to or greater than 0.1 % by

weight in substances and preparations

placed on the market.

However, this provision shall not apply

to waste containing one or more of

these substances and covered by

Directives 75/442/EEC and

78/319/EEC.

Such substances and preparations may

not be sold to the general public.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of such preparations shall be

legibly and indelibly marked as

follows

preparation

“Restricted to professional users”.

4-nitrobiphenyl

May not be used in concentrations

CAS No 92-93-3

equal to or greater than 0.1 % by

weight in substances and preparations

placed on the market.

However, this provision shall not apply

to waste containing one or more of

these substances and covered by

Directives 75/442/EEC and

78/319/EEC.

Such substances and preparations may

not be sold to the general public.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of such preparations shall be

legibly and indelibly marked as

follows

“Restricted to professional users”.

4-aminobiphenyl

May not be used in concentrations

CAS No 92-67-1 and its salts

equal to or greater than 0.1 % by

weight in substances and preparations

placed on the market.

However, this provision shall not apply

to waste containing one or more of

these substances and covered by

Directives 75/442/EEC and

78/319/EEC.

Such substances and preparations may

not be sold to the general public.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of such preparations shall be

legibly and indelibly marked as

follows

“Restricted to professional users”.

Lead carbons

May not be used as substances and

constituents of preparations intended

-

neutral anhydrous carbonate

for use as paints, except for the

preparation

PbCO 3 , CAS No 598-63-0

restoration and maintenance of works

- lead hydrocarbonate

of art and historic buildings and their

PbCO 3 .Pb(OH) 2 , CAS No 1319-46-

interiors, authorized in accordance with

the provision of ILO Convention 13 on

the use of white lead in paint.

Lead sulphates

May not be used as substances and

constituents of preparations intended

PbSO 4 (1:1)

for use as paints, except for the

CAS No 7446-14-2

restoration and maintenance of works

Pb x SO 4

of art and historic buildings and their

CAS No 15739-80-7

interiors, authorized in accordance with

the provision of ILO Convention 13 on

the use of sulphates of lead in paint.

Mercury compound

May not be used as substances and

constituents of preparations intended

for use

(a) to prevent the fouling by micro-

organisms, plants or animals of

- the hulls of boats,

- cages, floats, nets and any other

appliances or equipment used for

fish or shellfish farming,

- any totally or partly submerged

appliances or equipment;

(b) in the preservation of wood;

(c) in the impregnation of heavy-duty

industrial textiles and yarn intended

for their manufacture;

(d) in the treatment of industrial waters,

irrespective of their use.

Arsenic compounds

1. May not be used as substances and

constituents of preparations intended

for use

(a) To prevent the fouling by micro-

organisms, plants or animals of

— the hulls of boats,

— cages, floats, nets and any other

appliances or equipment used for fish

or shellfish farming,

— any totally or partly submerged

appliances or equipment;

(b) in the preservation of wood.

Furthermore, wood so treated may not

be placed on the market;

preparation

(c) however, by way of derogation

(i) Relating to the substances and

preparations in the preservation of

wood: these may only be used in

industrial installations using vacuum or

pressure to impregnate wood if they are

solutions of inorganic compounds of

the copper, chromium, arsenic (CCA)

type C. Wood so treated may not be

placed on the market before fixation of

the preservative is completed.

(ii) Relating to wood treated with CCA

solutions in industrial installations

according to point (i): this may be

placed on the market for professional

and industrial use provided that the

structural integrity of the wood is

required for human or livestock safety

and skin contact by the general public

during its service life is unlikely

— as structural timber in public and

agricultural buildings, office buildings,

and industrial premises,

— in bridges and bridgework,

— as constructional timber in

freshwater areas and brackish waters

e.g.jetties and bridges,

— as noise barriers,

— in avalanche control,

— in highway safety fencing and

barriers,

— as debarked round conifer livestock

fence posts,

— in earth retaining structures,

— as electric power transmission and

telecommunications poles,

— as underground railway sleepers.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, all treated

wood placed on the market shall be

individually labelled “Forprofessional

and industrial installation and use only,

preparation

contains arsenic”. In addition, all wood

placed on the market in packs shall also

bear a label stating “Wear gloves when

handling this wood. Wear a dust mask

and eye protection when cutting or

otherwise crafting this wood. Waste

from this wood shall be treated as

hazardous

by

an

authorised

undertaking”.

(iii) Treated wood referred to under

points (i) and (ii) may not be used

— in residential or domestic

constructions, whatever the purpose,

— in any application where there is a

risk of repeated skin contact,

— in marine waters,

— for agricultural purposes other than

for livestock fence posts and structural

uses in accordance with point (ii),

— in any application where the treated

wood may come into contact with

intermediate or finished products

intended for human and/or animal

consumption.

2. May not be used as substances and

constituents of preparations intended

for use in the treatment of industrial

waters, irrespective of their use.

Organostannic compounds

1. May not be placed on the market for

use

as

substances

and

constituents of preparations

when acting as biocides in free

association paint.

2. May not be placed on the market or

used

as

substances

and

constituents of preparations

which act as biocides to prevent

the fouling by microorganisms,

plants and animals of

(a)

tall craft irrespective of

their length intended for

use in marine, coastal,

estuarine and inland

waterways and lakes;

(b)

cages, floats, nets and

preparation

any other appliances or

equipment used for fish

or shellfish farming;

(c)

any totally or partly

submerged appliance or

equipment.

3. May not be used as substances and

constituents of preparations

intended for use in the treatment

of industrial waters.

Shall be prohibited in a concentration

di-µ-oxo-di-n-

equal to or greater than 0.1 % in

butylstanniohydroxyborane (DBB)

substances and constituents of

(C 8 H 19 BO 3 Sn),

preparations placed on the market.

CAS No 75113-37-0

However, this provision shall not apply

to this substance (DBB) or preparations

containing it if these are intended solely

for conversion into finished products,

among which this substance will no

longer feature in a concentration equal

to or greater than 0.1 %.

Pentachlorophenol

Shall not be used in a concentration

(CAS No 87-86-5)

equal to or greater than 0,1 % by mass

and its salts and esters

in substances or preparations placed on

the market.

By way of special exception, the

competent authority may on a case-by-

case basis, authorise specialised

professionals to carry out in situ and for

buildings of cultural, artistic and

historical interest, or in emergencies, a

remedial treatment of timber and

measonry infected by dry rot fungus

(Serpula lacrymans) and cubic rot

fungi.

In any case

(a) Pentachlorophenol used alone or as

a component of preparations employed

within the framework of the above

exception

must

have

a

total

hexachlorodibenzoparadioxin (HCDD)

content of not more than two parts per

million (ppm);

(b) these substances and preparations

preparation

may not

. be placed on the market except in

packages of 20 litres or more;

. be sold to the general public.

Without

prejudice

to

the

implementation of other provisions

concerning the classification, packaging

and labelling of dangerous substances

and preparations, the packaging of such

preparations should be marked clearly

and indelibly

“Reserved

for

industrial

and

professional use”

In addition, this provision shall not

apply to waste covered by Directives

75/442/EEC ( 6 ) and 91/689/EEC ( 7 ).

1.1 May not be used to give colour to finished

Cadmium (CAS No 7440-43-9) and its

products manufactured from the substances

compounds

and preparations listed below

-

polyvinyl chloride (PVC) [3904 10] [3904

21] [3904 22] ( 8 )

-

polyurethane (PUR) [3909 50]

-

low density polyethylene (ld PE), with the

exception of low-density polyethylene used

for the production of coloured masterbatch

[3901 10]

-

cellulose acetate (CA) [3912 11] [3912 12]

-

cellulose acetate butyrate (CAB) [3912 11]

[3912 12]

-

epoxy resins [3907 30]

In any case, whatever their use or intended final

purpose, finished products or components of

products manufactured from the substances and

preparations listed above coloured with

cadmium may not be placed on the market if

their cadmium content (expressed as Cd metal)

exceeds 0.01 % by mass of the plastic material.

1.2 Section 1.1 also applies for

(a) finished products manufactured from the

following substances and preparations

- melamine-formaldehyde (MF) [3909 20]

- urea-formaldehyde (UF) [3909 10]

- unsaturated polyesters (UP) [3907 91]

- polyethylene terephthalate (PET) [3907 60]

OJ L 194, 25.7.1975, p. 39.

OJ L 377, 31.12.1991, p. 20.

Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and

on the Common Customs Tariff (OJ No L 256, 7.9.1987).

preparation

-

polybutylene terephthalate (PBT)

-

transparent/general-purpose polystyrene

[3903 11] [3903 19]

- acrylonitrile methylmethacrylate (AMMA)

- cross-linked polyethylene (VPE)

- high-impact polystyrene

- polypropylene (PP) [3902 10]

(b) paints [3208] [3209]

However, if the paints have a high zinc content,

their residual concentration of cadmium must

be as low as possible and at all events not

exceed 0.1 % by mass.

1.3 However, Sections 1.1 and 1.2 do not

apply to products to be coloured for safety

reasons.

2.1 May not be used to stabilize the finished

products listed below manufactured from

polymers or copolymers of vinyl chloride

- packaging materials (bags, containers,

bottles, lids) [3923 29 10] [3920 41] [3920

42]

- office or school supplies [3926 10]

- fittings for furniture, coachwork or the like

[3926 30]

- articles of apparel and clothing accessories

(including gloves) [3926 20]

- floor and wall coverings [3918 10]

- impregnated, coated, covered or laminated

textile fabrics [5903 10]

- imitation leather [4202]

- gramophone records [8524 10]

- tubes and pipes and their fittings [3917 23]

- swing doors

- vehicles for road transport (interior,

exterior, underbody)

- coating of steel sheet used in construction

or in industry

- insulation for electrical wiring

In any case, whatever their use or intended final

purpose, the placing on the market of the above

finished products or components of products

manufactured from polymers or copolymers of

vinyl chloride, stablized by substances

containing cadmium is prohibited, if their

cadmium content (expressed as Cd metal)

exceeds 0.01 % by mass of the polymer.

2.2 However, Section 2.1 does not apply to

finished products using cadmium-based

stablizers for safety reasons.

3. Within the meaning of these Regulations,

“cadmium plating” means any deposit or

preparation

coating of metallic cadmium on a metallic

surface.

3.1 May not be used for cadmium plating

metallic products or components of the

products used in the sectors/applications

listed below.

(a) equipment and machinery for

- food production: [8210] [8417 20] [8419

81] [8421 11] [8421 22] [8422] [8435]

[8437] [8438] [8476 11]

- agriculture: [8419 31] [8424 81] [8432]

[8433] [8434] [8436]

- cooling and freezing: [8418]

- printing and book-binding: [8440] [8442]

[8443]

(b) equipment and machinery for the

production of

- household goods [7321] [8421 12] [8450]

[8509] [8516]

- furniture [8465] [8466] [9401] [9402]

[9403] [9404]

- sanitary ware [7324]

- central heating and air conditioning plant

[7322] [8403] [8404] [8415]

In any case, whatever their use or intended final

purpose, the placing on the market of cadmium-

plated products or components of such products

used in the sectors/applications listed in (a) and

(b) above and of products manufactured in the

sectors listed in (b) above is prohibited.

3.2 The provisions referred to in section 3.1

are also applicable to cadmium-plated

products or components of such products

when used in the sectors/applications listed

in (a) and (b) below and to products

manufactured in the sectors listed in (b)

below

(a) equipment and machinery for the

production of

- paper and board [8419 32] [8439] [8441]

- textiles and clothing [8444] [8445] [8447]

[8448] [8449] [8451] [8452]

(b) equipment and machinery for the

production of

- industrial handling equipment and

machinery [8425] [8426] [8427] [8428]

[8429] [8430] [8431]

- road and agricultural vehicles [chapter 87]

- rolling stock [chapter 86]

- vessels [chapter 89]

preparation

3.3 However, Sections 3.1 and 3.2 do not

apply to

- products and components of the products

used in the aeronautical, aerospace,

mining, offshore and nuclear sectors whose

applications require high safety standards

and in safety devices in road and

agricultural vehicles, rolling stock and

vessels,

- electrical contacts in any sector of use, on

account of the reliability required of the

apparatus on which they are installed.

Monomethyl-tetrachlorodiphenyl

The marketing and use of this

methane

substance and of preparations and

Trade name: Ugilec 141

products containing it shall be

CAS No 76253-60-6

prohibited.

By way of exception, this provision

shall not apply

1) in the case of plant and machinery

already in service on 18 June 1994

until such plant and machinery is

disposed of;

2) in the case of the maintenance of

plant and machinery already in

service on 18 June 1994.

The placing on the second hand market

of this substance, preparations

containing this substance and

plant/machinery containing this

substance, is prohibited.

Monomethyl-dichloro-

The marketing and use of this

diphenylmethane

substance and of preparations and

Trade name: Ugilec 121, Ugilec 21

products containing it shall be

CAS No – unknown

prohibited.

Monomethyl-dibromo-

The marketing and use of this

diphenylmethane

substance and of preparations and

Trade name: DBBT

products containing it shall be

CAS No 99688-47-8

prohibited.

Nickel

May not be used

CAS No 7440-02-0

1) in post assemblies which are

EINECS No 2311114

inserted into pierced ears and other

and its compounds

pierced parts of the human body

during epithelization of the wound

caused by piercing, whether

subsequently removed or not,

unless such post assemblies are

homogenous and the concentration

preparation

of nickel – expressed as mass of

nickel to total mass – is less than

0.05 %;

2) in products intended to come into

direct and prolonged contact with

the skin such as

- earrings,

- necklaces, bracelets and chains,

anklets, finger rings,

- wrist-watch cases, watch straps and

tighteners,

- rivet buttons, tighteners, rivets,

zippers and metal marks, when

these are used in garments

if the rate of nickel release from the

parts of these products coming into

direct and prolonged contact with the

skin is greater than 0.5 µg/cm 2 /week;

3) in products such as those listed in

point 2 where these have a non-

nickel coating unless such coating

is sufficient to ensure that the rate

of nickel release from those parts of

such products coming into direct

and prolonged contact with the skin

will not exceed 0.5 µg/cm 2 /week

for a period of at least two years of

normal use of the product.

Furthermore, products which are the

subject of points 1, 2 and 3 may not be

placed on the market unless they

conform to the requirements set out in

those points.

Substances which appear in Annex I to Without prejudice to the other points of

Directive 67/548/EEC classified as

this Schedule

carcinogen category 1 or carcinogen

May not be used in substances and

category 2 and labelled at least as

preparations placed on the market for

“Toxic (T)” with risk phrase R45

sale to the general public in individual

“May cause cancer” or risk phrase R49: concentration equal to or greater than

“may cause cancer by inhalation”, and - either the concentration specified in

listed as follows

Annex I to Council Directive

67/548/EEC, or

Carcinogen category 1

- the concentration specified in point

preparation

See List 1 in the Appendix to Council

6, Table VI, of Annex I to Council

Directive 88/379/EEC( 9 ), where no

Directive 76/769/EEC

Carcinogen category 2

concentration limit appears in

See List 2 in the Appendix to Council

Annex I to Directive 67/548/EEC.

Directive 76/769/EEC

Without prejudice to the

implementation of other provisions

relating to the classification, packaging

and labelling of dangerous substances

and preparations, the packaging of such

substances and preparations must be

marked legibly and indelibly as

follows

“Restricted to professional users.

Attention – Avoid exposure – obtain

special instructions before use”.

By way of derogation, this provision

shall not apply to

(a) medicinal or veterinary products

as defined by Council Directive

65/65/EEC;

(b) cosmetic products as defined by

the Cosmetic Products Order,

2000;

(c) motor fuels which are covered

by Council Directive

85/210/EEC ( 10 ),

- mineral oil products intended for

use as fuel in mobile or fixed

combustion plants,

- fuels sold in closed systems (e.g.

liquid gas bottles);

(d) artists’ paints covered by

Council Directive 88/379/EEC.

Substances which appear in Annex I to

Without prejudice to the other points of

Directive 67/548/EEC classified as

this Schedule

mutagen category 1 or mutagen

category 2 and labelled with risk phrase

May not be used in substances and

R46: “May cause heritable genetic

preparations placed on the market for

damage”, and listed as follows

sale to the general public in individual

concentration equal to or greater than

Mutagen category 1

- either the concentration specified in

See List 3 in the Appendix to Council

Annex 1 to Directive 67/548/EEC,

OJ No L 187, 16.7.1988, p.14

OJ No L 96, 3.4.1985, p.25

preparation

Directive 76/769/EEC

or

-

the concentration specified in point

Mutagen category 2

6, Table VI, of Annex I to Directive

See List 4 in the Appendix to Council

88/379/EEC where no

Directive 76/769/EEC

concentration limit appears in

Annex 1 to Directive 67/548/EEC.

Without prejudice to the

implementation of other provisions

relating to the classification, packaging

and labelling of dangerous substances

and preparations, the packaging of such

substances and preparations must be

marked legibly and indelibly as

follows: “Restricted to professional

users. Attention – Avoid exposure –

obtain special instructions before use”.

This provision shall not apply to

(a) medicinal or veterinary products as

defined by Directive 65/65/EEC

( 11 );

(b) cosmetic products as defined by the

Cosmetic Products Order 2000

(L.N. 204 of 2000);

(c) motor fuels which are covered by

Directive 85/210/EEC ( 12 ),

(d) mineral oil products intended for

use as fuel in mobile or fixed

combustion plants,

(e) fuels sold in closed systems (e.g.

liquid gas bottles),

(f) artists’ paints covered by Directive

88/379/EEC ( 13 )

Substances which appear in Annex I to

Without prejudice to the other points of

Directive 67/548/EEC classified as

this Schedule

toxic for reproductive purposes

May not be used in substances and

category 1 or toxic for reproductive

preparations placed on the market for

purposes category 2 and labelled with

sale to the general public in individual

risk phrase R60: “May impair fertility”

concentration equal to or greater than

and/or R61: “May cause harm to the

- either the concentration specified in

unborn child”, and listed as follows

Annex 1 to Directive 67/548/EEC,

or

OJ No L 22, 9.2.1965, p.369/65.

OJ No L 96, 3.4.1985, p.25

OJ No L 187, 16.7.1988, p.14.

preparation

Toxic for reproductive purposes

-

the concentration specified in point

category 1

6, Table VI, of Annex I to Directive

See List 5 in the Appendix to Council

88/379/EEC where no

Directive 76/769/EEC

concentration limit appears in

Annex 1 to Directive 67/548/EEC.

Toxic for reproductive purposes

Without prejudice to the

category 2

implementation of other provisions

See List 6 in the Appendix to Council

relating to the classification, packaging

Directive 76/769/EEC

and labelling of dangerous substances

and preparations, the packaging of such

substances and preparations must be

marked legibly and indelibly as

follows: “Restricted to professional

users. Attention – Avoid exposure –

obtain special instructions before use”.

This provision shall not apply to

(a) medicinal or veterinary products as

defined by Directive 65/65/EEC

( 14 );

(b) cosmetic products as defined by the

Cosmetic Products Order 2000

(L.N. 204 of 2000);

(c) motor fuels which are covered by

Directive 85/210/EEC ( 15 ),

(d) mineral oil products intended for

use as fuel in mobile or fixed

combustion plants,

(e) fuels sold in closed systems (e.g.

liquid gas bottles),

(f) artists’ paints covered by Directive

88/379/EEC ( 16 )

As from 30 th June 2003, the substances

Substances and preparations containing

one or more of the following

and preparations listed in point 32

substances

(a) Creosote, Einecs No 232-287-5,

1. May not be used in the treatment of

CAS No 8001-58-9

wood. Furthermore, wood so treated

(b) Creosote oil, Einecs No 263-047-8,

may not be placed on the market

CAS No 61789-28-4

(c) Distillates (coal tar), naphthalene

2. However by way of derogation

oils, Einecs No 283-484-8, CAS No

(i) Relating to the substances and

84650-04-4

preparations: these may be used for

OJ No 22, 9.2.1965, p.369/65.

OJ No L 96, 3.4.1985, p.25

OJ No L 187, 16.7.1988, p.14.

preparation

(d) Creosote oil, acenaphthalene

wood

treatment

in

industrial

fraction, Einecs No 292-605-3,

installations or by professionals

CAS No 90640-84-9

covered by legislation on the protection

(e) Distillates (coal tar), upper, Einecs

of workers for in situ retreatment only

No. 266-026-1, CAS No 65996-91-

if they contain

(a) benzo-a-pyrene at a concentration of

(f) Anthracene oil, Einecs No. 292-

less than 0,005 % by mass

602-7, CAS No 90640-80-5

(b) and water extractable phenols at a

(g) Tar Acids, Coal, Crude, Einecs No

concentration of less than 3 % by mass.

266-019-3, CAS No 65996-85-2

Such substances and preparations for

(h) Creosote, wood, Einecs No 232-

use in wood treatment in industrial

419-1, CAS No 8021-39-4

installations or by professionals

(i) Low temperature tar oil, alkaline,

— may be placed on the market only in

Einecs No 310-191-5, CAS No

packaging of a capacity equal to or

122384-78-5

greater than 20 litres,

— may not be sold to consumers.

Without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of such substances and

preparations shall be legibly and

indelibly marked “For use in industrial

installations or professional treatment

only”.

(ii) Relating to wood treated in

industrial

installations

or

by

professionals according to (i) which is

placed on the market for the first time

or retreated in-situ: this is permitted for

professional and industrial use only,

e.g. on railways, in electric power

transmission and telecommunications,

for fencing, for agricultural purposes

(e.g. stakes for tree support) and in

harbours and waterways.

(iii) Relating to wood having been

treated with substances listed in point

32(a) to (i) before 30 th June 2003: the

prohibition in point 1 on the placing on

the market shall not apply where this is

placed on the second-hand market for

re-use.

3. However, treated wood referred to

preparation

under point 2(ii) and (iii) may not be

used

— inside buildings, whatever their

purpose,

— in toys,

— in playgrounds,

— in parks, gardens, and outdoor

recreational and leisure facilities where

there is a risk of frequent skin contact,

— in the manufacture of garden

furniture such as picnic tables,

— for the manufacture and use and any

re-treatment of

— containers intended for growing

purposes,

— packaging that may may come into

contact

with

raw

materials,

intermediate or finished products

destined for human and/or animal

consumption,

— other materials which may

contaminate the products mentioned

above.

Provided further that the provisions of

point 32 of the First Schedule of the

Dangerous Substances and Preparations

(Restrictions) Regulations 2001 (L.N.

152 of 2001) shall continue to apply

between 1 st July 2002 and 30 th June

2003.

Chloroform

May not be used in concentrations

CAS No 67-66-3

equal to or greater than 0.1 % by

Carbon tetrachloride

weight in substances and preparations

CAS No 56-23-5

placed on the market for sale to the

1,1,2-Trichloroethane

general public and/or in diffusive

CAS No 79-00-5

applications such as in surface cleaning

1,1,2,2-Tetrachloroethane

and cleaning of fabrics.

CAS No 79-34-5

1,1,1,2-Tetrachloroethane

Without prejudice to the

CAS No 630-20-6

implementation of other provisions

Pentachloroethane

relating to the classification, packaging

CAS No 76-01-7

and labelling of dangerous substances

1,1-Dichloroethylene

and preparations, the packaging of such

CAS No 75-35-4

substances and preparations containing

preparation

1,1,1-Trichloroethane

them in concentrations equal to or

CAS No 71-55-6

greater than 0.1 % shall be marked

legibly and indelibly as follows: “For

use in industrial installations only”.

This provision shall not apply to

(a) medicinal or veterinary products as

defined by Directive 65/65/EEC

( 17 );

(b) cosmetic products as defined by the

Cosmetic Products Order 2000

(L.N. 204 of 2000);

Substances

1. May not be used as such or in the

either

form of preparations in aerosol

- appearing in Annex I to Directive

generators marketed and intended

67/548/EEC which are classified as

for sale to the general public for

flammable or extremely flammable

entertainment and decorative

and labelled as such,

purposes such as the following

or

- metallic glitter intended mainly for

- not yet appearing in Annex I to

decorations,

Directive 67/548/EEC but

- artificial snow and frost,

conforming to the criteria of

- ‘whoopee’ cushions,

flammability of Annex VI to

- silly string aerosols,

Directive 67/548/EEC and being

- imitation excrement,

provisionally classified and labelled

- horn for parties,

as flammable, highly flammable or

- decorative flakes and foams,

extremely flammable according to

- artificial cobwebs,

Article 5(2) of Directive

- stink bombs,

67/548/EEC.

- etc.

2. Without prejudice to the

implementation of other provisions

relating to the classification,

packaging and labelling of

dangerous substances, the following

words must appear legibly and

indelibly on the packaging of

aerosol generators referred to

above: “For professional users

only”.

3. Paragraphs 1 and 2 shall not apply

to the aerosol generators referred to

in Article 9a of Directive

OJ No 22, 9.2.1965, p.369/65.

preparation

75/324/EEC.

4. The products referred to above may

not be placed on the market unless

they conform to the requirements

indicated.

xx Hexachloroethane

May not be used in the manufacturing

CAS No 67-72-1

or processing of non-ferrous metals.

EINECS No 2006664

Alkanes, C 10 -C 13 , chloro (short-chain

May not be placed on the market for

chlorinated paraffins)

use as substances or as constituents of

other substances or preparations in

concentrations higher than 1 %

— in metalworking;

— for fat liquoring of leather.

Azocolourants

As from 30 June 2004

1. Azodyes which, by reductive

cleavage of one or more azo groups,

may release one or more of the

aromatic amines listed in the Second

Schedule, in detectable concentrations,

i.e. above 30 ppm in the finished

articles or in the dyed parts thereof,

according to the testing method

established in accordance with Article

2(a) of Council Directive 76/769/EEC,

may not be used in textile and leather

articles which may come into direct and

prolonged contact with the human skin

or oral cavity, such as

—

clothing,

bedding,

towels,

hairpieces, wigs, hats, nappies and

other sanitary items, sleeping bags,

— footwear, gloves, wristwatch straps,

handbags, purses/wallets, briefcases,

chaircovers, purses worn round the

neck,

— textile or leather toys and toys which

include textile or leather garments,

— yarn and fabrics intended for use by

the final consumer.

2. Furthermore, the textile and leather

Articles referred to in point 1 above

may not be placed on the market unless

preparation

they conform to the requirements set

out in that point;

provided that, until 1 January 2005, this

provision shall not apply to textile

articles made of recycled fibres if the

amines are released by residues

deriving from previous dyeing of the

same fibres and if the listed amines are

released in concentrations

below 70 ppm.

3. Azodyes, which are contained in the

“List of azodyes” that is hereby added

to the Second Schedule, may not be

placed on the market or used for

colouring textile and leather articles as

a substance or constituent of

preparations in concentrations higher

than 0,1 % by mass.

provided that the provisions of point 44

of the Dangerous Substances and

Preparations (Restrictions) Regulations

2002 (L.N. 142/2002), as amended by

L.N. 394/2002, shall continue to apply

until 30 June 2004.

Diphenyl ether, pentabromo derivative

As from 15 August 2004

C 12 H 5 Br 5 O

1. May not be placed on the market or

used as a substance or as a constituent

of substances or of preparations in

concentrations higher than 0.1 % by

mass.

2. Articles may not be placed on the

market if they, or flame-retarded parts

thereof, contain this substance in

concentrations higher than 0.1 % by

mass.

Diphenyl ether, octabromo derivative

As from 15 August 2004

C 12 H 2 Br 8 O

1. May not be placed on the market or

used as a substance or as a constituent

of substances or of preparations in

concentrations higher than 0.1 % by

mass.

preparation

2. Articles may not be placed on the

market if they, or flame-retarded parts

thereof, contain this substance in

concentrations higher than 0.1 % by

mass.

(1) Nonylphenol C 6 H 4 (OH)C 9 H 19

As from 17 January 2005

May not be placed on the market or

(2) Nonylphenol ethoxylate

used as a substance or constituent of

(C 2 H 4 O) n C 15 H 24 O

preparations in concentrations equal or

higher than 0,1 % by mass for the

following purposes

(1) industrial and institutional cleaning

except

— controlled closed dry cleaning

systems where the washing liquid is

recycled or incinerated,

— cleaning systems with special

treatment where the washing liquid is

recycled or incinerated;

(2) domestic cleaning;

(3) textiles and leather processing

except

— processing with no release into

waste water,

— systems with special treatment

where the process water is pretreated to

remove the organic fraction completely

prior to biological waste water

treatment (degreasing of sheepskin);

(4) emulsifier in agricultural teat dips;

(5) metal working except

— uses in controlled closed systems

where the washing liquid is recycled or

incinerated;

(6) manufacturing of pulp and paper;

(7) cosmetic products;

(8) other personal care products except

— spermicides;

preparation

(9) co-formulants in pesticides and

biocides.

Cement

As from 17 January 2005

(1) Cement and cement-containing

preparations may not be used or placed

on the market, if they contain, when

hydrated, more than 0,0002 % soluble

chromium VI of the total dry weight of

the cement.

(2) If reducing agents are used, then

without prejudice to the application of

other provisions on the classification,

packaging and labelling of dangerous

substances and preparations, the

packaging of cement or cement-

containing preparations shall be legibly

and indelibly marked with information

on the packing date, as well as on the

storage conditions and the storage

period appropriate to maintaining the

activity of the reducing agent and to

keeping the content of soluble

chromium VI below the limit indicated

in paragraph 1.

(3) By way of derogation, paragraphs 1

and 2 shall not apply to the placing on

the market for, and use in, controlled

closed and totally automated processes

in which cement and cement-containing

preparations are handled solely by

machines and in which there is no

possibility of contact with the skin.

B

Second Schedule

List of aromatic amines

CAS number

Index

EC number

Substances

number

92-67-1

612-072-00-6

202-177-1

biphenyl-4-ylamine

4-aminobiphenyl

xenylamine

92-87-5

612-042-00-2

202-199-1

Benzidine

95-69-2

202-441-6

4-chloro-o-toluidine

91-59-8

612-022-00-3

202-080-4

2-naphthylamine

97-56-3

611-006-00-3

202-591-2

o-aminoazotoluene

4-amino-2’,3-

dimethylazobenzene

4-o-tolylazo-o-toluidine

99-55-8

202-765-8

5-nitro-o-toluidine

106-47-8

612-137-00-9

203-401-0

4-chloroaniline

615-05-4

210-406-1

4-methoxy-m-

phenylenediamine

101-77-9

612-051-00-1

202-974-4

4,4’-methylenedianiline

4,4’-

diaminodiphenylmethane

91-94-1

612-068-00-4

202-109-0

3,3’-dichlorobenzidine

3,3’-dichlorobiphenyl-

4,4’-ylenediamine

119-90-4

612-036-00-X

204-355-4

3,3’-dimethoxybenzidine

o-dianisidine

119-93-7

612-041-00-7

204-358-0

3,3’-dimethylbenzidine

4,4’-bi-o-toluidine

838-88-0

612-085-00-7

212-658-8

4,4’-methylenedi-o-

toluidine

120-71-8

204-419-1

6-methoxy-m-toluidine p-

cresidine

101-14-4

612-078-00-9

202-918-9

4,4’-methylene-bis-(2-

chloro-aniline)

2,2’-dichloro-4,4’-

methylene-dianiline

101-80-4

202-977-0

4,4’-oxydianiline

139-65-1

205-370-9

4,4’-thiodianiline

95-53-4

612-091-00-X

202-429-0

o-toluidine

2-aminotoluene

95-80-7

612-099-00-3

202-453-1

4-methyl-m-

phenylenediamine

137-17-7

205-282-0

2,4,5-trimethylaniline

90-04-0

612-035-00-4

201-963-1

o-anisidine 2-

methoxyaniline

60-09-3

611-008-00-4

200-453-6

4-amino azobenzene

List of azodyes

CAS Number

Index

EC number

Substances

number

Not allocated

611-070-00-

405-665-4

A mixture of: disodium

(6-(4-anisidino)-3-

Component 1

sulfonato-2-(3,5-dinitro-

CAS-No: 118685-33-9

2-oxidophenylazo)-

C 39 H 30 ClCrN 7 O 12 S.2Na

1-naphtholato)(1-(5-

Component 2

chloro-2-

C 46 H 30 CrN 10 O 20 S 2 .3Na

oxidophenylazo)-2-

naphtholato)chromate(1-

);

trisodium bis(6-(4-

anisidino)-3-sulfonato-

2-(3,5-dinitro-2-

oxidophenylazo)-1-

naphtholato)chromate(1-

)

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press