SAFETY OF TOYS REGULATIONS

SUBSIDIARY LEGISLATION 427.40

SAFETY OF TOYS REGULATIONS

20th July, 2011

LEGAL NOTICE 50 of 2011, as amended by Legal Notices 341 of 2012,

188 of 2014, 191 of 2015, 106 of 2017, 359 of 2018, 215 of 2019 and 267 of

2021 and 212 of 2022.

(1) The title of these regulations is the Safety of Toys

Regulations.

(2) These regulations lay down rules on the safety of toys and

on their free movement in the Community and transpose the

following

(a) Directives 88/378/EEC, 2008/112/EC, 2009/48/ EC,

and 2012/7/EU;

(b) Commission Directive (EU) 2015/2115 of 23

November 2015 amending, for the purpose of adopting

specific limit values for chemicals used in toys,

Appendix C to Annex II to Directive 2009/48/EC of

the European Parliament and of the Council on the

safety of toys, as regards formamide;

(c) Commission Directive (EU) 2015/2116 of 23

November 2015 amending, for the purpose of adopting

specific limit values for chemicals used in toys,

Appendix C to Annex II to Directive 2009/48/EC of

the European Parliament and of the Council on the

safety of toys, as regards benzisothiazolinone;

(d) Commission Directive (EU) 2015/2117 of 23

November 2015 amending, for the purpose of adopting

specific limit values for chemicals used in toys,

Appendix C to Annex II to Directive 2009/48/EC of

the European Parliament and of the Council on the

safety of toys, as regards chloromethylisothiazolinone

and methylisothiazolinone, both individually and in a

ratio of 3:1;

(e) Council Directive (EU) 2017/738 of 27 March 2017

amending, for the purpose of adapting to technical

progress, Annex II to Directive 2009/48/EC of the

European Parliament and of the Council on the safety

of toys, as regards lead;

(f)

Commission Directive (EU) 2017/774 of 3 May 2017

amending, for the purpose of adopting specific limit

values for chemicals used in toys, Appendix C to

Annex II to Directive 2009/48/EC of the European

Parliament and of the Council on the safety of toys, as

regards phenol;

(g) Commission Directive (EU) 2017/898 of 24 May 2017

amending, for the purpose of adopting specific limit

values for chemicals used in toys, Appendix C to

SAFETY OF TOYS

Annex II to Directive 2009/48/EC of the European

Parliament and of the Council on the safety of toys, as

regards bisphenol A;

(h) * Commission Directive (EU) 2018/725 of 16 May 2018

amending, for the purpose of adaptation to technical

and scientific developments, point 13 of part III of

Annex II to Directive 2009/48/EC of the European

Parliament and of the Council on the safety of toys, as

regards chromium VI;

(i)

Commission Directive (EU) 2019/1922 of 18

November 2019 amending, for the purposes of

adaptation to technical and scientific developments,

point 13 of part III of Annex II to Directive 2009/48/

EC of the European Parliament and of the Council on

the safety of toys, as regards aluminium;

(j)

Commission Directive (EU) 2019/1929 of 19 November

2019 amending Appendix C to Annex II to Directive

2009/48/EC of the European Parliament and of the

Council for the purpose of adopting specific limit values

for chemicals used in certain toys, formaldehyde;

(k) Commission Directive (EU) 2020/2088 of 11 December

2020 amending Annex II to Directive 2009/48/EC of the

European Parliament and of the Council as regards the

labelling of allergenic fragrances in toys;

(l)

Commission Directive (EU) 2020/2089 of 11 December

2020 amending Annex II to Directive 2009/48/EC of the

European Parliament and of the Council as regards the

prohibition of allergenic fragrances in toys; and

(m) Commission Directive (EU) 2021/903 of 3 June 2021

amending Directive 2009/48/EC of the European

Parliament and of the Council as regards specific limit

values for aniline in certain toys.

(3) These regulations shall apply to toys falling under the

scope of the principal regulations.

(4) Regulation 1(2)(h) shall come into force on the 18th

November 2019.

Amended by

L.N. 341 of 2012;

Particular Safety Requirements

L.N. 191 of 2015;

L.N. 359 of 2018;

(Regulation 9)

L.N. 215 of 2019;

L.N. 267 of 2021;

L.N. 212 of 2022.

Physical and Mechanical Properties

(1) Toys and their parts and, in the case of fixed toys, their anchorages, must

have the requisite mechanical strength and, where appropriate, stability to withstand

the stresses to which they are subjected during use without breaking or becoming

liable to distortion at the risk of causing physical injury.

(2) Accessible edges, protrusions, cords, cables and fastenings on toys must be

designed and manufactured in such a way that the risks of physical injury from

contact with them are reduced as far as possible.

(3) Toys must be designed and manufactured in such a way as not to present any

risk or only the minimum risk inherent to their use which could be caused by the

movement of their parts.

(4)

(a) Toys and their parts must not present a risk of strangulation.

(b) Toys and their parts must not present a risk of asphyxiation by closing

off the flow of air as a result of airway obstruction external to the mouth

and nose.

(c) Toys and their parts must be of such dimensions as to not present a risk

of asphyxiation by closing off the flow of air as a result of internal

airway obstruction by objects wedged in the mouth or pharynx or

lodged over the entrance to the lower airways.

(d) Toys, which are clearly intended for use by children under thirty-six

months, and their component parts and any of their detachable parts

must be of such dimensions as to prevent their being swallowed or

inhaled. This also applies to other toys which are intended to be put in

the mouth, and to their component parts and any of their detachable

parts.

(e) The packaging in which toys are contained for retail sale must not

present a risk of strangulation or asphyxiation caused by airway

obstruction external to the mouth and nose.

(f)

Toys contained within food or co-mingled with food must have their

own packaging. This packaging, as it is supplied, must be of such

dimensions as to prevent its being swallowed or inhaled.

(g) Toy packaging, as referred to in paragraphs (e) and (f), which is

spherical, eggshaped or ellipsoidal, and any detachable parts of this or

of cylindrical toy packaging with rounded ends, must be of such

dimensions as to prevent it from causing airway obstruction by being

wedged in the mouth or pharynx or lodged over the entrance to the

lower airways.

(h) Toys firmly attached to a food product at the moment of consumption,

in such a way that the food product needs to be consumed in order to get

direct access to the toy, shall be prohibited. Parts of toys otherwise

directly attached to a food product shall fulfil the requirements set out

in paragraphs (c) and (d).

(5) Aquatic toys must be designed and manufactured so as to reduce as far as

possible, taking into account the recommended use of the toy, any risk of loss of

buoyancy of the toy and loss of support afforded to the child.

(6) Toys which it is possible to get inside and which thereby constitute an

enclosed space for occupants must have a means of exit which the intended user can

open easily from the inside.

(7) Toys conferring mobility on their users must, as far as possible, incorporate

a braking system which is suited to the type of toy and is commensurate with the

kinetic energy generated by it. Such a system must be easy for the user to operate

without risk of ejection or physical injury for the user or for third parties. The

maximum design speed of electrically driven ride-on toys must be limited so as to

minimise the risk of injury.

(8) The form and composition of projectiles and the kinetic energy they may

generate when fired from a toy designed for that purpose must be such that, taking

into account the nature of the toy, there is no risk of physical injury to the user or to

third parties.

(9)

Toys must be manufactured so as to ensure that

(a) the maximum and minimum temperature of any accessible surfaces does

not cause injury when touched; and

(b) liquids and gases contained within the toy do not reach temperatures or

pressures which are such that their escape from the toy, other than for

reasons essential to the proper functioning of the toy, might cause burns,

scalds or other physical injury.

(10) Toys which are designed to emit a sound shall be designed and manufactured

in such a way in terms of the maximum values for impulse noise and continuous

noise that the sound from them is not able to impair children’s hearing.

(11) Activity toys shall be manufactured so as to reduce the risk of crushing or

trapping of body parts or trapping of clothing and of falls, impacts and drowning as

far as possible. In particular, any surface of such a toy accessible for one or more

children to play on shall be designed to bear their load.

II.

Flammability

(1) Toys must not constitute a dangerous flammable element in the child’s

environment. They must therefore be composed of materials which fulfil one or

more of the following conditions

(a) they do not burn if directly exposed to a flame or spark or other

potential source of fire;

(b) they are not readily flammable (the flame goes out as soon as the fire

cause disappears);

(c) if they do ignite, they burn slowly and present a low rate of spread of

the flame;

(d) irrespective of the toy’s chemical composition, they are designed so as

to mechanically delay the combustion process.

Such combustible materials must not constitute a risk of ignition for other

materials used in the toy.

(2) Toys which, for reasons essential to their functioning, contain substances or

mixtures that meet the classification criteria laid down below, in particular materials

and equipment for chemistry experiments, model assembly, plastic or ceramic

moulding, enamelling, photography or similar activities, must not contain, as such,

substances or mixtures which may become flammable due to the loss of non-

flammable volatile components.

As a result of the timing of the application of Regulation (EC) No 1272/2008,

there are equivalent ways of referring to a given classification that should be used at

different points in time, as shown below

(a) Criteria for classifying substances and mixtures for the purposes above

applicable as from the 20th July 2011 until the 31st May 2015

Substances

The substance fulfils the criteria for any of the following hazard classes

or categories set out in Annex I to Regulation (EC) No 1272/2008

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10,

2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types

A to F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function

and fertility or on development, 3.8 effects other than narcotic

effects, 3.9 and 3.10;

(iii) hazard class 4.1;

(iv) hazard class 5.1.

Mixtures

The mixture is dangerous within the meaning of the Classification,

Labelling and Packaging of Substances and Mixtures (CLP)

(Implementation) Regulations.

(b) Criteria to be applied as from the 1st June 2015

The substance or mixture fulfils the criteria for any of the following

hazard classes or categories set out in Annex I to Regulation (EC) No

1272/2008

(i)

hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10,

2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types

A to F;

(ii) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function

and fertility or on development, 3.8 effects other than narcotic

effects, 3.9 and 3.10;

(iii) hazard class 4.1;

(iv) hazard class 5.1.

(3) Toys other than toy percussion caps must not be explosive or contain

elements or substances likely to explode when used as specified in regulation 9(5).

(4) Toys and, in particular, chemical games and toys, must not contain as such

substances or mixtures

(a) which, when mixed together, may explode through chemical reaction or

through heating;

(b) which may explode when mixed with oxidizing substances; or

(c) which contain volatile components which are flammable in air and

liable to form a flammable or explosive vapour/air mixture.

III. Chemical Properties applicable as from the 20th July 2011 until the 19th

(1) Toys must be so designed and constructed that, when used as specified in

regulation 9(5), they do not present health hazards or risks of physical injury by

ingestion, inhalation or contact with the skin, mucous tissues or eyes. They must in

all cases comply with the relevant local or Community legislation relating to certain

categories of products or to the prohibition, restriction of use or labelling of certain

dangerous substances and mixtures.

(2) In particular, for the protection of children’s health, bioavailability resulting

from the use of toys must not, as an objective, exceed the following levels per day

(a) 0.2 µg for antimony,

(b) 0.1 µg for arsenic,

(c) 25.0 µg for barium,

(d) 0.6 µg for cadmium,

(e) 0.3 µg for chromium,

(f)

0.7 µg for lead,

(g) 0.5 µg for mercury,

(h) 5.0 µg for selenium,

or such other values as may be laid down for these or other substances in Community

legislation based on scientific evidence. The bioavailability of these substances

means the soluble extract having toxicological significance.

(3)

(a) Toys must not contain mixtures which are dangerous within the meaning

of the Dangerous Substances and Preparations Regulations, or

substances fulfilling the criteria for any of the following hazard classes

or categories set out in the Classification, Labelling and Packaging of

Substances and Mixtures (CLP) (Implementation) Regulations, and

Annex I to Regulation (EC) No 1272/2008

(i)

Hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9,

2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15

types A to F;

(ii) Hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function

and fertility or on development, 3.8 effects other than narcotic

effects, 3.9 and 3.10;

(iii) Hazard class 4.1;

(iv) Hazard class 5.1,

in amounts which may harm the health of children using them. In any

event it is strictly forbidden to include, in a toy, such substances or

mixtures if they are intended to be used as such while the toy is being

used.

(b) However, where a limited number of substances or mixtures are

essential to the functioning of certain toys, in particular materials and

equipment for chemistry experiments, model assembly, plastic or

ceramic moulding, enamelling, photography or similar activities, they

are permitted up to a maximum concentration level as may be defined

for each substance or mixture by the European Committee for

Standardisation (CEN), provided the permitted substances and mixtures

comply with the local or Community classification rules in respect of

labelling, without prejudice to Schedule VI, part B, section 4.

Chemical Properties applicable as from the 20th July 2013

(1)

(a) Toys shall be designed and manufactured in such a way that there are no

risks of adverse effects on human health due to exposure to the chemical

substances or mixtures of which the toys are composed or which they

contain when the toys are used as specified in regulation 9(5).

(b) Toys shall comply with the relevant local or Community legislation

relating to certain categories of products or to restrictions for certain

substances and mixtures.

(2) Toys that are themselves substances or mixtures must comply also with the

Classification, Labelling and Packaging of Substances and Mixtures (CLP)

(Implementation) Regulations, the Dangerous Substances and Preparations

Regulations, and Regulation (EC) No 1272/2008 as applicable, relating to the

classification, packaging and labelling of certain substances and mixtures.

(3) Without prejudice to the restrictions referred to in the second paragraph of

point 1, substances that are classified as carcinogenic, mutagenic or toxic for

reproduction (CMR) of category 1A, 1B or 2 under Regulation (EC) No 1272/2008

shall not be used in toys, in components of toys or in micro-structurally distinct parts

(4) By way of derogation from point 3, substances or mixtures classified as

CMR of the categories laid down in point 7 below may be used in toys, in

components of toys or micro-structurally distinct parts of toys provided that one or

more of the following conditions is met

(a) these substances and mixtures are contained in individual

concentrations equal to or smaller than the relevant concentrations

established in the local or Community legal acts referred to in point 6

below for the classification of mixtures containing these substances;

(b) these substances and mixtures are inaccessible to children in any form,

including inhalation, when the toy is used as specified in the regulation

9(5);

(c) a decision in accordance with Article 46(3) of Directive 2009/48/EC has

been taken to permit the substance or mixture and its use, and the

substance or mixture and its permitted uses have been listed in Schedule

II. That decision may be taken if the following conditions are met

(i)

the use of the substance or mixture has been evaluated by the

relevant Scientific Committee and found to be safe, in particular

in view of exposure;

(ii) there are no suitable alternative substances or mixtures available,

as documented in an analysis of alternatives; and

(iii) the substance or mixture is not prohibited for use in consumer

articles under Regulation (EC) No 1907/2006.

(5) By way of derogation from point 3, substances or mixtures classified as

CMR of the categories laid down in point 8 below may be used in toys, in

components of toys or micro-structurally distinct parts of toys provided that one of

the following conditions is met

(a) these substances and mixtures are contained in individual

concentrations equal to or smaller than the relevant concentrations

established in the local or Community legal acts referred to in point 6

below for the classification of mixtures containing these substances;

(b) these substances and mixtures are inaccessible to children in any form,

including inhalation, when the toy is used as specified in regulation

9(5); or

(c) a decision in accordance with Article 46(3) of Directive 2009/48/EC has

been taken to permit the substance or mixture and its use, and the

substance or mixture and its permitted uses have been listed in Schedule

II. That decision may be taken if the following conditions are met

(i)

the use of the substance or mixture has been evaluated by the

relevant Scientific Committee and found to be safe, in particular

in view of exposure;

(ii) the substance or mixture is not prohibited for use in consumer

articles under Regulation (EC) No 1907/2006.

(6) Local and Community legal acts governing the use of certain substances for

the purposes of points 4(a) and 5(a) above

(a) as from the 20th July 2011 until the 31st May 2015, the relevant

concentrations for the classification of mixtures containing the

substances shall be those established in accordance with the Dangerous

Substances and Preparations Regulations;

(b) as from the 1st June 2015, the relevant concentrations for the

classification of mixtures containing the substances shall be those

established in accordance with Regulation (EC) No 1272/2008.

(7) Categories of substances and mixtures classified as carcinogenic, mutagenic

or toxic for reproduction (CMR) for the purposes of point 4 above

(a) Substances

Point 4 concerns substances classified as CMR category 1A and 1B

under Regulation (EC) No 1272/2008.

(b) Mixtures

As from the 20st July 2011 until the 31st May 2015, point 4 concerns

mixtures classified as CMR category 1 and 2 under the Classification,

Labelling and Packaging of Substances and Mixtures (CLP)

(Implementation) Regulations, and the Dangerous Substances and

Preparations Regulations, as applicable.

As from the 1st June 2015, point 4 concerns mixtures classified as CMR

category 1A and 1B under Regulation (EC) No 1272/2008.

(8) Categories of substances and mixtures classified as carcinogenic, mutagenic

or toxic for reproduction (CMR) for the purposes of point 5

(a) Substances

Point 5 concerns substances classified as CMR category 2 under

Regulation (EC) No 1272/2008.

(b) Mixtures

As from the 20th July 2011 until the 31st May 2015, point 5 concerns

mixtures classified as CMR category 3 under the Classification,

Labelling and Packaging of Substances and Mixtures (CLP)

(Implementation) Regulations, and the Dangerous Substances and

Preparations Regulations, as applicable.

As from the 1st June 2015, point 5 concerns mixtures classified as CMR

category 2 under Regulation (EC) No 1272/2008.

(9)

Points 3, 4 and 5 shall not apply to nickel in stainless steel.

(10) Points 3, 4 and 5 shall not apply to materials that comply with the specific

limit values set out in Schedule III, or, until such provisions have been laid down,

but not later than the 20th July 2017, to materials covered by and complying with the

provisions for food contact materials set out in Regulation (EC) No 1935/2004 and

the related specific measures for particular materials.

(11) Without prejudice to the application of points 3 and 4, nitrosamines and

nitrosable substances shall be prohibited for use in toys intended for use by children

under 36 months or in other toys intended to be placed in the mouth if the migration

of the substances is equal to or higher than 0.05 mg/kg for nitrosamines and 1 mg/kg

for nitrosable substances.

(12) Cosmetic toys, such as play cosmetics for dolls, shall comply with the

compositional and labelling requirements laid down in the Cosmetic Products

Regulations.

(13) Toys shall not contain the following allergenic fragrances

No

Name of the allergenic fragrance

CAS Number

1 Alanroot oil (Inula helenium)

97676-35-2

2 Allylisothiocyanate

57-06-7

3 Benzyl Cyanide

140-29-4

4 4 tert-Butylphenol

98-54-4

5 Chenopodium oil

8006-99-3

6 Cyclamen alcohol

4756-19-8

7 Diethyl maleate

141-05-9

8 Dihydrocoumarin

119-84-6

9 2,4-Dihydroxy-3-methylbenzaldehyde

6248-20-0

10 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)

40607-48-5

11 4,6-Dimethyl-8-tert-butylcoumarin

17874-34-9

12 Dimethyl citraconate

617-54-9

13 7,11-Dimethyl-4.6,10-dodecatrien-3-one

26651-96-7

14 6,10-Dimethyl-3.5,9-undecatrien-2-one

141-10-6

15 Diphenylamine

122-39-4

16 Ethyl acrylate

140-88-5

17 Fig leaf, fresh and preparations

68916-52-9

18 trans-2-Heptenal

18829-55-5

19 trans-2-Hexenal diethyl acetal

67746-30-9

20 trans-2-Hexenal dimethyl acetal

18318-83-7

21 Hydroabietyl alcohol

13393-93-6

22 4-Ethoxy-phenol

622-62-8

23 6-lsopropyl-2-decahydronaphthalenol

34131-99-2

24 7-Methoxycoumarin

531-59-9

25 4-Methoxyphenol

150-76-5

26 4-(p-Methoxyphenyl)-3-butene-2-one

943-88-4

27 1-(p-Methoxyphenyl)-1-penten-3-one

104-27-8

28 Methyl trans-2-butenoate

623-43-8

29 6-Methylcoumarin

92-48-8

7-Methylcoumarin

2445-83-2

5-Methyl-2,3-hexanedione

13706-86-0

Costus root oil (Saussurea lappa Clarke)

8023-88-9

7-Ethoxy-4-methylcoumarin

87-05-8

Hexahydrocoumarin

700-82-3

Peru balsam, crude (Exudation of Myroxylon pereirae (Royle)

8007-00-9

Klotzsch)

2-Pentylidene-cyclohexanone

25677-40-1

3.6,10-Trimethyl-3.5,9-undecatrien-2-one

1117-41-5

Verbena oil (Lippia citriodora Kunth)

8024-12-2

Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)

83-66-9

4-Phenyl-3-buten-2-one

122-57-6

Amyl cinnamal

122-40-7

Amylcinnamyl alcohol

101-85-9

Benzyl alcohol

100-51-6

Benzyl salicylate

118-58-1

Cinnamyl alcohol

104-54-1

Cinnamal

104-55-2

Citral

5392-40-5

Coumarin

91-64-5

Eugenol

97-53-0

Geraniol

106-24-1

Hydroxy-citronellal

107-75-5

Hydroxy-methylpentylcyclohexenecarboxaldehyde

31906-04-4

Isoeugenol

97-54-1

Oakmoss extracts

90028-68-5

Treemoss extracts

90028-67-4

Nº

Name of the allergenic fragrance

CAS number

Atranol (2,6-Dihydroxy-4-methyl-benzaldehyde)

526-37-4

Chloroatranol (3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde)

57074-21-2

Methyl heptine carbonate

111-12-6

However, the presence of traces of these fragrances shall be allowed provided that

such presence is technically unavoidable under good manufacturing practice and

does not exceed 100 mg/kg.

In addition, the names of the following allergenic fragrances shall be listed on the

toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to

a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components

thereof

No

Name of the allergenic fragrance

CAS Number

1 Anisyl alcohol

105-13-5

2 Benzyl benzoate

120-51-4

3 Benzyl cinnamate

103-41-3

(4)

Citronellol

5 Farnesol

6 Hexyl cinnamaldehyde

7 Lilial

8 d-Limonene

9 Linalool

10 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

Acetylcedrene

Amyl salicylate

trans-Anethole

Benzaldehyde

Camphor

Carvone

beta-Caryophyllene (ox.)

Rose ketone-4 (Damascenone)

alpha-Damascone (TMCHB)

cis-beta-Damascone

delta-Damascone

Dimethylbenzyl carbinyl acetate (DMBCA)

Hexadecanolactone

Hexamethylindanopyran

(DL)-Limonene

Linalyl acetate

Menthol

Methyl salicylate

3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl) pent-4-en-2-ol

alpha-Pinene

beta-Pinene

Propylidene phthalide

Salicylaldehyde

alpha-Santalol

beta-Santalol

Sclareol

alpha-Terpineol

10482-56-1;

98-55-5

Terpineol (mixture of isomers)

8000-41-7

Terpinolene

586-62-9

Tetramethyl acetyloctahydro naphthalenes

54464-57-2;

54464-59-4;

68155-66-8;

68155-67-9

Trimethyl benzenepropanol (Majantol)

103694-68-4

Vanillin

121-33-5

Cananga odorata and Ylang-ylang oil

83863-30-3;

8006-81-3

Cedrus atlantica bark oil

92201-55-3;

8000-27-9

Cinnamomum cassia leaf oil

8007-80-5

Cinnamomum zeylanicum bark oil

84649-98-9

Citrus aurantium amara flower oil

8016-38-4

Citrus aurantium amara peel oil

72968-50-4

Citrus bergamia peel oil expressed

89957-91-5

Citrus limonum peel oil expressed

84929-31-7

Citrus sinensis (syn.: Aurantium dulcis) peel oild expressed

97766-30-8;

8028-48-6

Cymbopogon citratus/schoenanthus oils

89998-14-1;

8007-02-01;

89998-16-3

Eucalyptus spp. leaf oil

92502-70-0;

8000-48-4

Eugenia caryophyllus leaf/flower oild

8000-34-8

Jasminum grandiflorum/officinale

84776-64-7;

90045-94-6;

8022-96-6

Juniperus virginiana

8000-27-9;

85085-41-2

Laurus nobilis fruit oil

8007-48-5

Laurus nobilis leaf oil

8002-41-3

Laurus nobilis seed oil

84603-73-6

Lavandula hybrida

91722-69-9

Lavandula officinalis

84776-65-8

Mentha piperita

8006-90-4;

84082-70-2

Mentha spicata

84696-51-5

Narcissus spp.

Diverse,

including

90064-25-8

Pelargonium graveolens

90082-51-2;

8000-46-2

Pinus mugo

90082-72-7

Pinus pumila

97676-05-6

Pogostemon cablin

8014-09-3;

84238-39-1

Rose flower oil (Rosa spp.)

Diverse,

including

8007-01-0,

93334-48-6,

84696-47-9,

84604-12-6,

90106-38-0,

84604-13-7,

92347-25-6

Santalum album

84787-70-2;

8006-87-9

8006-64-2;

Turpentine (oil)

9005-90-7;

8052-14-0

(14) The use of the fragrances set out in points 41 to 55 of the list set out in the

first paragraph of point 13 and of the fragrances set out in points 1 to 11 of the list

set out in the third paragraph of that point shall be allowed in olfactory board games,

33 cosmetic kits and gustative games, provided that

(i)

those fragrances are clearly labelled on the packaging, and the

packaging contains the warning set out in point 10 of Part B of

Schedule VI;

(ii) if applicable, the resulting products made by the child in

accordance with the instructions comply with the requirements of

the Cosmetic Products Regulations; and

(iii) if applicable, those fragrances comply with the relevant

legislation on food.

Such olfactory board games, cosmetic kits and gustative games shall not be used

by children under 36 months and shall comply with point 1 of Part B of Schedule VI.

(15) Without prejudice to points 3, 4 and 5, the following migration limits, from

toys or components of toys, shall not be exceeded

Element

mg/kg in dry,

mg/kg in

mg/kg in

brittle,

liquid or

scraped-off

powder-like

sticky toy

toy

or pliable toy

material

material

material

Aluminium

28130

Antimony

11.3

Arsenic

3.8

0.9

Barium

18750

Boron

15000

Cadmium

1.3

0.3

Chromium (III)

(1) These regulations shall apply to products designed or

intended, whether or not exclusively, for use in play by children

under fourteen years of age, hereinafter referred to as "toys".

(2) These regulations shall not apply, in particular, to the

following products

(a) playground equipment intended for public use;

(b) automatic playing machines, whether coin operated or

not, intended for public use;

(c) toy vehicles equipped with combustion engines;

(d) toy steam engines;

*Comes into Force on 18th November 2019.

(e) slings and catapults;

(f)

decorative objects for festivities and celebrations;

(g) products for collectors, provided that the product or its

packaging bears a visible and legible indication that it

is intended for collectors of fourteen years of age and

above. Examples of this category are

(i) detailed and faithful scale models,

(ii) kits for the assembly of detailed scale models,

(iii) folk dolls and decorative dolls and other similar

articles,

(iv) historical replicas of toys, and

(v) reproductions of real fire arms;

(h) sports equipment, including roller skates, inline skates

and skateboards, intended for children with a body

mass of more than 20kg;

(i)

bicycles with a maximum saddle height of more than

435mm, measured as the vertical distance from the

ground to the top of the seat surface, with the seat in a

horizontal position and with the seat pillar set to the

minimum insertion mark;

(j)

scooters and other means of transport designed for

sport or which are intended to be used for travel on

public roads or public pathways;

(k) electrically driven vehicles which are intended to be

used for travel on public roads, public pathways, or the

pavement thereof;

(l)

aquatic equipment intended to be used in deep water,

and swimming learning devices for children, such as

swim seats and swimming aids;

(m) puzzles with more than 500 pieces;

(n) guns and pistols using compressed gas, with the

exception of water guns and water pistols, and bows

for archery over 120cm long;

(o) fireworks, including percussion caps, which are not

specifically designed for toys;

(p) products and games using sharp-pointed missiles, such

as sets of darts with metallic points;

(q) functional educational products, such as electric

ovens, irons or other functional products operated at a

nominal voltage exceeding 24 volts which are sold

exclusively for teaching purposes under adult

supervision;

(r) products intended for use for educational purposes in

schools and other pedagogical contexts under the

surveillance of an adult instructor, such as science

equipment;

(s) electronic equipment, such as personal computers and

game consoles, used to access interactive software and

their associated peripherals, unless the electronic

equipment or the associated peripherals are

specifically designed for an targeted at children and

have a play value on their own, such as specially

designed personal computers, keyboards, joy sticks or

steering wheels;

(t)

interactive software, intended for leisure and

entertainment, such as computer games, and their

storage media, such as CDs;

(u) babies’ soothers;

(v) child-appealing luminaries;

(w) electrical transformers for toys;

(x) fashion accessories for children which are not for use

in play.

Substituted by

L.N. 191 of 2015.

List of Cmr Substances and their Permitted Uses in accordance with

(Points 4, 5 and 9 of Part IV of Schedule I)

Substance

Classification

Permitted use

Nickel

CMR 2

In toys and toy components

made of stainless steel

In toy components which are

intended to conduct an electric

current

For the purposes of these regulations, the following

definitions shall apply

" a c c r e d i ta t i o n" sh a l l h a v e th e m e a n i ng a s s i g n e d t o i t b y

Regulation (EC) No 765/2008;

"the Act" means the Product Safety Act;

"activity toy" means a toy for domestic use in which the support

structure remains stationary while the activity is taking place and

which is intended for the performance by a child of any of the

following activities: climbing, jumping, swinging, sliding, rocking,

spinning, crawling and creeping, or any combination thereof;

"aquatic toy" means a toy intended for use in shallow water

which is capable of carrying or supporting a child on the water;

"authorised representative" means any natural or legal person

established in Malta or within the Community who has received a

written mandate from a manufacturer to act on his behalf in relation

to specified tasks;

"CE marking" means the marking by which the manufacturer

indicates that the toy is in conformity with the applicable

requirements set out in Community harmonisation legislation

providing for its affixing;

"chemical toy" means a toy intended for the direct handling of

chemical substances and mixtures and which is used in a manner

appropriate to a given age-group and under the supervision of an

adult;

"the Community" means the European Community;

"Community harmonisation legislation" means any Community

legislation harmonising the conditions for marketing of products;

"conformity assessment" means the process demonstrating

whether specified requirements relating to a toy have been

fulfilled;

"conformity assessment body" means a body designated in

accordance with the Method for Designating Conformity

Assessment Bodies Regulations, that performs conformity

assessment activities, including calibration, testing, certification

and inspection;

"cosmetic kit" means a toy the purpose of which is to assist a

child to learn to make products such as fragrances, soaps, creams,

shampoos, bath foams, glosses, lipsticks, other make-up, tooth-

paste and conditioners;

"design speed" means representative potential operating speed

that is determined by the design of the toy;

"distributor" means any natural or legal person in the supply

chain, other than the manufacturer or the importer, who makes a toy

available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"functional product" means a product which performs and is used

in the same way as a product, appliance or installation intended for

use by adults and which may be a scale model of such product,

appliance or installation;

"functional toy" means a toy which performs and is used in the

same way as a product, appliance or installation intended for use by

adults, and which may be a scale model of such product, appliance

or installation;

"gustative game" means a toy the purpose of which is to allow

children to make sweets or dishes which involve the use of food

ingredients such as sweets, liquids, powders and aromas;

"harm" means physical injury or any other damage to health,

including long-term health effects;

"harmonised standard" means a standard adopted by the Malta

Standards Authority or one of the European Standardisation bodies

listed in Schedule I to the Notification Procedure Regulations, on

the basis of a request made by the Commission in accordance with

Article 6 of Directive 98/34/EC;

"hazard" means a potential source of harm;

"importer" means any natural or legal person established in

Malta or within the Community who places a toy from a third

country on the local or Community market;

"intended for use by" means that a parent or supervisor shall

reasonably be able to assume by virtue of the functions, dimensions

and characteristics of a toy that it is intended for use by children of

the stated age group;

"making available on the market" means any supply of a toy for

distribution, consumption or use on the local or Community market

in the course of a commercial activity, whether in return for

payment or free of charge;

"manufacturer" means any natural or legal person who

manufactures a toy or has a toy designed or manufactured, and

markets that toy under his name or trademark;

"Market Surveillance Directorate" means the Market

Surveillance Directorate of the Malta Standards Authority as

described in the Malta Standards Authority (Establishment of

Directorates) Order;

"market surveillance" means the activities carried out and

measures taken by the Market Surveillance Directorate to ensure

that toys comply with the applicable requirements set out in

Community harmonisation legislation and do not endanger health

or any other aspect of public interest protection;

"National Accreditation Board (Malta)" means the National

Accreditation Board (Malta) established in terms of regulation 3 of

the National Accreditation Board (Malta) (Establishment)

Regulations;

"olfactory board game" means a toy the purpose of which is to

assist a child to learn to recognise different odours or flavours;

"placing on the market" means the first making available of a toy

on the local or Community market;

"recall" means any measure aimed at achieving the return of a

toy that has already been made available to the end user;

"Regulatory Affairs Directorate" means the Regulatory Affairs

Directorate of the Malta Standards Authority as described in the

Malta Standards Authority (Establishment of Directorates) Order;

"risk" means the probable rate of occurrence of a hazard causing

harm and the degree of severity of the harm;

"withdrawal" means any measure aimed at preventing a toy in

the supply chain from being made available on the market;

Amended by

L.N. 191 of 2015;

L.N. 106 of 2017;

L.N. 359 of 2018;

L.N. 267 of 2021;

L.N. 212 of 2022.

Specific Limit Values for Chemicals used in Toys intended for use by Children under

36 months or in Toys intended to be placed in the mouth

(Article 46(2) of Directive 2009/48/EC)

Substance

CAS Number

Limit value

TCEP

115-96-8

5 mg/kg (content limit)

TCPP

13674-84-5

5 mg/kg (content limit)

TDCP

13674-87-8

5 mg/kg (content limit)

Bisphenol A

80-05-7

0,04 mg/l (migration limit) in accordance with the

methods laid down in EN 71-10:2005 and EN 71-

11:2005

20 μg/m 3 (emission limit) after a maximum of 28

Formamide

75-12-7

days from commencement of the emission testing

of foam toy materials containing more than 200

mg/kg (cut-off limit based on content).

Aniline

62-53-3

30 mg/kg after reductive cleavage in textile toy

material

10 mg/kg and leather toy material

30mg/kg as free aniline in finger paints after

reductive cleavage in finger paints

Phenol

108-95-2

5 mg/l (migration limit) in polymeric materials

in accordance with the methods laid down in EN

71-10:2005 and EN 71-11:2005

10mg/kg (content limit) as a preservative in

accordance with the methods laid down in EN

71-10:2005 and EN 71-11:2005

1,2-benzisothiazol-

2634-33-5

5 mg/kg (content limit) in aqueous toy materials,

3(2H)-one

in accordance with the methods laid down in EN

71-10:2005 and EN 71-11:2005

reaction mass of: 5-

55965-84-9

1 mg/kg (content limit) in aqueous toy materials

chloro-2- methyl-4-

isothiazolin- 3-one [EC

no. 247-500-7] and 2-

methyl-2H -isothiazol-

3-one [EC no. 220-239-

6] (3:1)

5-Chloro-2-methyl-

26172-55-4

0,75 mg/kg (content limit) in aqueous toy

isothiazolin-3(2H)-one

materials

2-methylisothiazolin-

2682-20-4

0,25 mg/kg (content limit) in aqueous toy

3(2H)-one

materials

Formaldehyde

50-00-0

1,5 mg/l (migration limit) in polymeric toy

material

0,1 ml/m3 (emission limit) in resin-bonded

wood toy material

30 mg/kg (content limit) in textile toy material

30 mg/kg (content limit) in leather toy material

30 mg/kg (content limit) in paper toy material

10 mg/kg (content limit) in water-based toy

material

(1) When placing their toys on the market, manufacturers

shall ensure that the toys have been designed and manufactured in

accordance with the requirements set out in regulation 9 and

Schedule I.

(2)

(a) Manufacturers shall draw up the required technical

documentation in accordance with regulation 14 and

carry out or have carried out the applicable conformity

assessment procedure in accordance with regulation

EC Declaration of Conformity

(Regulation 12)

1. Unique identification of the toy;

2. Name and address of the manufacturer or his authorised representative;

3. A statement that the declaration of conformity is issued under the sole

responsibility of the manufacturer;

4. Object of the declaration (identification of toy allowing traceability). It shall

include a colour image of sufficient clarity to enable the identification of the toy;

5. A statement that the object of the declaration described in point 4 is in

conformity with the relevant local or Community harmonisation legislation;

6. References to the relevant harmonised standards used, or references to the

specifications in relation to which conformity is declared;

7. Where applicable, the notified body?fs name and number, together with a

description of its intervention with respect to the conformity assessment of the toy,

including the reference of the certificate issued;

8. Signature of person acting for and on behalf of the manufacturer or the

authorised representative. This shall include the name and function of such person;

9. Place and date of issue.

Technical Documentation

(Regulation 14)

The technical documentation referred to in regulations 14(1) to (4) shall contain,

in particular, so far as relevant for assessment

(a) a detailed description of the design and manufacture, including a list of

components and materials used in the toy as well as the safety data

sheets on chemicals used, to be obtained from the chemical suppliers;

(b) the safety assessment carried out in accordance with regulation 13(2);

(c) a description of the conformity assessment procedure followed;

(d) a copy of the EC declaration of conformity;

(e) the addresses of the places of manufacture and storage;

(f)

copies of documents that the manufacturer has submitted to a notified

body, if involved;

(g) test reports and description of the means whereby the manufacturer

ensured conformity of production with the harmonised standards, if the

manufacturer followed the internal production control procedure

referred to in regulation 13(4); and

(h) a copy of the EC-type examination certificate, a description of the

means whereby the manufacturer ensured conformity of the production

with the product type as described in the EC-type examination

certificate, and copies of the documents that the manufacturer submitted

to the notified body, if the manufacturer submitted the toy to EC-type

examination and followed the conformity to type procedure referred to

in regulation 13(5).

Warnings

(Regulation 10)

PART A - General warnings

The user limitations referred to in regulation 10(1) shall include at least the

minimum or maximum age of the user and, where appropriate, the abilities of the

user, the maximum or minimum weight of the user and the need to ensure that the

toy is used only under adult supervision.

PART B - Specific warnings and indications of precautions to be taken when using

certain categories of toys

1. Toys not intended for use by children under 36 months

Toys which might be dangerous for children under 36 months of age shall bear a

warning such as "Not suitable for children under 36 months" or "Not suitable for

children under three years" or a warning in the form of the following graphic

These warnings shall be accompanied by a brief indication, which may appear in

the instructions for use, of the specific hazard calling for this precaution.

This point shall not apply to toys which, on account of their function, dimensions,

characteristics or properties, or on other cogent grounds, are manifestly unsuitable

for children under 36 months.

2. Activity toys

Activity toys shall bear the following warning: "Only for domestic use".

Activity toys attached to a crossbeam as well as other activity toys, where

appropriate, shall be accompanied by instructions drawing attention to the need to

carry out checks and maintenance of the main parts (suspensions, fixings,

anchorages, etc.) at intervals, and pointing out that, if these checks are not carried

out, the toy may cause a fall or overturn.

Instructions must also be given as to the correct assembly of the toy, indicating

those parts which can present a danger if incorrectly assembled. Specific information

regarding a suitable surface on which to place the toy shall be given.

3. Functional toys

Functional toys shall bear the following warning: "To be used under the direct

supervision of an adult".

In addition, these toys shall be accompanied by directions giving working

instructions as well as the precautions to be taken by the user, with the warning that

failure to take these precautions will expose the user to the hazards - to be specified .

normally associated with the appliance or product of which the toy is a scale model

or imitation. It shall also be indicated that the toy must be kept out of the reach of

children under a certain age, which shall be specified by the manufacturer.

4. Chemical toys

Without prejudice to the application of the provisions laid down in applicable

local or Community legislation on the classification, packaging and labelling of

certain substances or mixtures, the instructions for use of toys containing inherently

dangerous substances or mixtures shall bear a warning of the dangerous nature of

these substances or mixtures and an indication of the precautions to be taken by the

user in order to avoid hazards associated with them, which shall be specified

concisely according to the type of toy. The first aid to be given in the event of

serious accidents resulting from the use of this type of toy shall also be mentioned. It

shall also be stated that the toy must be kept out of reach of children under a certain

age, which shall be specified by the manufacturer.

In addition to the instructions provided for in the first subparagraph, chemical toys

shall bear the following warning on their packaging

"Not suitable for children under ( * ) years. For use under adult supervision".

In particular, the following are regarded as chemical toys: chemistry sets, plastic

embedding sets, miniature workshops for ceramics, enamelling or photography and

similar toys which lead to a chemical reaction or similar substance alteration during

use.

5. Skates, roller skates, online skates, skateboards, scooters and toy bicycles

for children

Where these toys are offered for sale as toys, they shall bear the following

warning: "Protective equipment should be worn. Not to be used in traffic".

Moreover, the instructions for use shall contain a reminder that the toy must be

used with caution, since it requires great skill, so as to avoid falls or collisions

causing injury to the user or third parties. Some indication shall also be given as to

recommended protective equipment (helmets, gloves, knee-pads, elbow-pads, etc.).

6. Aquatic toys

Aquatic toys shall bear the following warning: "Only to be used in water in which

the child is within its depth and under adult supervision".

7. Toys in food

Toys contained in food or co-mingled with food shall bear the following warning

"Toy inside. Adult supervision recommended".

*Age to be specified by the manufacturer.

8. Imitations of protective masks and helmets

Imitations of protective masks and helmets shall bear the following warning

"This toy does not provide protection".

9. Toys intended to be strung across a cradle, cot or perambulator by means of

strings, cords, elastics or straps

Toys intended to be strung across a cradle, cot or perambulator by means of

strings, cords, elastics or straps shall carry the following warning on the packaging,

which shall also be permanently marked on the toy: "To prevent possible injury by

entanglement, remove this toy when the child starts trying to get up on its hands and

knees in a crawling position".

10. Packaging for fragrances in olfactory board games, cosmetic kits and

gustative games

Packaging for fragrances in olfactory board games, cosmetic kits and gustative

games that contain the fragrances set out in points 41 to 55 of the list set out in the

first paragraph of point 13 of Part IV of Schedule I and of the fragrances set out in

points 1 to 11 of the list set out in third paragraph of that point shall contain the

following warning: "Contains fragrances that may cause allergies".

Internal Production Control

(Regulation 13)

(1) Internal production control is the conformity assessment procedure whereby

the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures

and declares on his sole r esponsibility that the toys concerned satisfy the

requirements of the legislative instrument that apply to them.

(2)

Technical Documentation

The manufacturer shall establish the technical documentation. The documentation

shall make it possible to assess the toy’s conformity to the relevant requirements,

and shall include an adequate analysis and assessment of any risk. The technical

documentation shall specify the applicable requirements and cover, as far as relevant

for the assessment, the design, manufacture and operation of the toy. The technical

documentation shall, wherever applicable, contain at least the following elements

-

a general description of the toy,

-

conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.,

-

descriptions and explanations necessary for the understanding of those

drawings and schemes and the operation of the toy,

-

a list of the harmonised standards or other relevant technical

specifications the references of which have been published in the

Official Journal of the European Union, applied in full or in part, and

descriptions of the solutions adopted to meet the essential requirements

of the legislative instrument where those harmonised standards have not

been applied. In the event of partly applied harmonised standards, the

technical documentation shall specify the parts which have been

applied,

-

results of design calculations made, examinations carried out, etc., and

-

test reports.

(3)

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure compliance of the manufactured toys with the

technical documentation referred to in point 2 and with the requirements of the

legislative instruments that apply to them.

(4)

Conformity marking and declaration of conformity

The manufacturer shall affix the required conformity marking set out in the

l e g i s l a t i v e i n s t r u m e nt t o e a c h i n di v i d u a l t o y t h a t s a t i s f i e s t he a p p li c a bl e

requirements of the legislative instrument.

The manufacturer shall draw up a written declaration of conformity for a toy

model and keep it together with the technical documentation at the disposal of the

Market Surveillance Directorate for 10 years after the toy has been placed on the

market. The declaration of conformity shall identify the toy for which it has been

drawn up.

A copy of the declaration of conformity shall be made available to the Market

Surveillance Directorate upon request.

(5)

Authorised representative

The manufacturer ’s obligations set out in point 4 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

EC-Type Examination

(Regulation 13)

(1) EC-type examination is the part of a conformity assessment procedure in

which a notified body examines the technical design of a toy and verifies and attests

that the technical design of the toy meets the requirements of the legislative

instrument that apply to it.

(2)

EC-type examination may be carried out in either of the following manners

-

examination of a specimen, representative of the production envisaged,

of the complete toy (production type),

-

assessment of the adequacy of the technical design of the toy through

examination of the technical documentation and supporting evidence

referred to in point 3, plus examination of specimens, representative of

the production envisaged, of one or more critical parts of the toy

(combination of production type and design type),

-

assessment of the adequacy of the technical design of the toy through

examination of the technical documentation and supporting evidence

referred to in point 3, without examination of a specimen (design type).

(3) The manufacturer shall lodge an application for EC-type examination with a

single notified body of his choice. The application shall include

-

the name and address of the manufacturer and, if the application is

lodged by the authorised representative, his name and address as well,

a written declaration that the same application has not been lodged with

any other notified body,

the technical documentation. The technical documentation shall make it

possible to assess the toy?fs conformity with the applicable

requirements of the legislative instrument and shall include an adequate

analysis and assessment of the risks. The technical documentation shall

specify the applicable requirements and cover, as far as relevant for the

assessment, the design, manufacture and operation of the toy. The

technical documentation shall contain, wherever applicable, at least the

following elements

i.

a general description of the toy,

ii.

conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, etc.,

iii.

descriptions and explanations necessary for the understanding of

those drawings and schemes and the operation of the toy,

iv.

a list of the harmonised standards or other relevant technical

specifications the references of which have been published in the

Official Journal of the European Union, applied in full or in part,

and descriptions of the solutions adopted to meet the essential

requirements of the legislative instrument where those

harmonised standards have not been applied. In the event of partly

applied harmonised standards, the technical documentation shall

specify the parts which have been applied,

v.

results of design calculations made, examinations carried out,

etc., and

vi.

test reports,

the specimens representative of the production envisaged. The notified

body may request further specimens if needed for carrying out the test

programme,

the supporting evidence for the adequacy of the technical design

solution. This supporting evidence shall mention any documents that

have been used, in particular where the relevant harmonised standards

or technical specifications have not been applied in full. The supporting

evidence shall include, where necessary, the results of tests carried out

by the appropriate laboratory of the manufacturer, or by another testing

laboratory on his behalf and under his responsibility.

(4)

The notified body shall

For the product

examine the technical documentation and supporting evidence to assess

the adequacy of the technical design of the toy;

For the specimen

verify that the specimen has been manufactured in conformity with the

technical documentation, and identify the elements which have been

designed in accordance with the applicable provisions of the relevant

harmonised standards or technical specifications, as well as the

elements which have been designed without applying the relevant

provisions of those standards;

carry out appropriate examinations and tests, or have them carried out,

to check whether, where the manufacturer has chosen to apply the

solutions in the relevant harmonised standards

or

technical

specifications, these have been applied correctly;

c)

carry out appropriate examinations and tests, or have them carried out,

to check whether, where the solutions in the relevant harmonised

standards or technical specifications have not been applied, the

solutions adopted by the manufacturer meet the corresponding essential

requirements of the legislative instrument;

d)

agree with the manufacturer on a location where the examinations and

tests will be carried out.

(5) The notified body shall draw up an evaluation report that records the

activities undertaken in accordance with point 4 and their outcomes. Without

prejudice to its obligations vis-a vis the notifying authorities, the notified body shall

release the content of that report, in full or in part, only with the agreement of the

manufacturer.

(6) Where the type meets the requirements of the specific legislative instrument

that apply to the product concerned, the notified body shall issue an EC-type

examination certificate to the manufacturer. The certificate shall contain the name

and address of the manufacturer, the conclusions of the examination, the conditions

(if any) for its validity and the necessary data for identification of the approved type.

The certificate may have one or more annexes attached.

The certificate and its annexes shall contain all relevant information to allow the

conformity of manufactured products with the examined type to be evaluated and to

allow for in-service control.

Where the type does not satisfy the applicable requirements of the legislative

instrument, the notified body shall refuse to issue an EC-type examination certificate

and shall inform the applicant accordingly, giving detailed reasons for its refusal.

(7) The notified body shall keep itself apprised of any changes in the generally

acknowledged state of the art which indicate that the approved type may no longer

comply with the applicable requirements of the legislative instrument, and shall

determine whether such changes require further investigation. If so, the notified

body shall inform the manufacturer accordingly.

The manufacturer shall inform the notified body that holds the technical

documentation relating to the EC-type examination certificate of all modifications to

the approved type that may affect the conformity of the product with the essential

requirements of the legislative instrument or the conditions for validity of the

certificate. Such modifications shall require additional approval in the form of an

addition to the original EC-type examination certificate.

(8) Each notified body shall inform its notifying authority concerning the EC-

type examination certificates or any additions thereto which it has issued or

withdrawn, and shall, periodically or upon request, make available to its notifying

authority the list of certificates or any additions thereto refused, suspended or

otherwise restricted.

Each notified body shall inform the other notified bodies concerning the EC-type

examination certificates or any additions thereto which it has refused, withdrawn,

suspended or otherwise restricted, and, upon request, concerning the certificates or

additions thereto which it has issued.

The Regulatory Affairs Directorate and the other notified bodies may, on request,

obtain a copy of the EC-type examination certificates or additions thereto. On

request, the Regulatory Affairs Directorate may obtain a copy of the technical

documentation and the results of the examinations carried out by the notified body.

The notified body shall keep a copy of the EC-type examination certificate, its

annexes and additions, as well as the technical file including the documentation

submitted by the manufacturer, until the expiry of the validity of the certificate.

(9) The manufacturer shall keep a copy of the EC-type examination certificate,

its annexes and additions together with the technical documentation at the disposal

of the Market Surveillance Directorate for 10 years after the toy has been placed on

the market.

(10) The manufacturer’s authorised representative may lodge the application

referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that

they are specified in the mandate.

Conformity to Type based on Internal Production Control

(Regulation 13)

(1) Conformity to type based on internal production control is the part of a

conformity assessment procedure whereby the manufacturer fulfils the obligations

laid down in points 2 and 3, and ensures and declares that the toys concerned are in

conformity with the type described in the EC-type examination certificate and

satisfy the requirements of the legislative instrument that apply to them.

(2)

Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing

process and its monitoring ensure conformity of the manufactured toys with the

approved type described in the EC-type examination certificate and with the

requirements of the legislative instrument that apply to them.

(3) Conformity marking and declaration of conformity The manufacturer shall

affix the required conformity marking set out in the legislative instrument to each

individual toy that is in conformity with the type described in the EC-type

examination certificate and satisfies the applicable requirements of the legislative

instrument.

The manufacturer shall draw up a written declaration of conformity for a toy

model and keep it at the disposal of the Market Surveillance Directorate for 10 years

after the toy has been placed on the market. The declaration of conformity shall

identify the toy model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the Market

Surveillance Directorate upon request.

(4) Authorised representative

The manufacturer ’s obligations set out in point 3 may be fulfilled by his

authorised representative, on his behalf and under his responsibility, provided that

they are specified in the mandate.

CE-Marrking

(Regulation 11)

1. The CE marking shall consist of the initials "CE" taking the following form

2. If the CE marking is reduced or enlarged, the proportions given in the

graduated drawing in paragraph 1 shall be respected.

3. Where specific legislation does not impose specific dimensions, the CE

marking shall be at least 5 mm high.

(b) Where compliance of a toy with the applicable

requirements has been demonstrated by that procedure,

manufacturers shall draw up an EC declaration of

conformity, as referred to in regulation 12, and affix

the CE marking, as set out in regulation 11.

(3) Manufacturers shall keep the technical documentation and

the EC declaration of conformity at the disposal of the Market

Surveillance Directorate for a period of ten years after the toy has

been placed on the market.

(4) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity. Changes in toy design or

characteristics and changes in the harmonised standards by

reference to which conformity of a toy is declared shall be

adequately taken into account.

(5) When deemed appropriate with regard to the risks presented

by a toy, manufacturers shall, to protect the health and safety of

consumers, carry out sample testing of marketed toys, investigate

and keep a register of complaints, of non-conforming toys and toy

recalls, and shall keep distributors informed of any such

monitoring. They shall keep such register at the disposal of the

Market Surveillance Directorate.

(6) Manufacturers shall ensure that their toys bear a type,

batch, serial or model number or other element allowing their

identification, or, where the size or nature of the toy does not allow

it, that the required information is provided on the packaging or in

a document accompanying the toy.

(7) Manufacturers shall indicate their name, registered trade

name or registered trade mark and the address at which they can be

contacted on the toy or, where that is not possible, on its packaging

or in a document accompanying the toy. The address shall indicate

a single point at which the manufacturer can be contacted.

(8) Manufacturers shall ensure that the toy is accompanied by

instructions and safety information. All information accompanying

the toy and on the toy itself must be in, at least, the English or

Maltese language.

(9) Manufacturers who consider or have reason to believe that

a toy which they have placed on the market is not in conformity

with the relevant Community harmonisation legislation shall

immediately take the corrective measures necessary to bring that

toy into conformity, to withdraw it or recall it, if appropriate.

Furthermore, where the toy presents a risk, manufacturers shall

immediately inform the Market Surveillance Directorate giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(10) Manufacturers shall, further to a reasoned request from the

Market Surveillance Directorate, provide that Directorate with all

the information and documentation necessary to demonstrate the

conformity of the toy, in the English or Maltese language. They

shall cooperate with that Directorate, at its request, as regards any

action taken to eliminate the risks posed by toys which they have

placed on the market.

5. (1) A manufacturer established outside the Community

may, by a written mandate, appoint an authorised representative

established in Malta or within the Community.

(2) The obligations laid down in regulation 4(1) and the

drawing up of technical documentation shall not form part of the

authorised representative’s mandate.

(3) The authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a) keep the EC declaration of conformity and the

technical documentation at the disposal of the Market

Surveillance Directorate for a period of ten years after

the toy has been placed on the market;

(b) further to a reasoned request from the Market

Surveillance Directorate, provide that Directorate with

all the information and documentation necessary to

demonstrate the conformity of the toy, in the English

or Maltese language;

(c) co-operate with the Market Surveillance Directorate,

at its request, as regards any action taken to eliminate

the risks posed by toys covered by the mandate.

6. (1) Importers shall only place toys that comply to these

regulations on the local or Community market.

(2) Before placing a toy on the market, importers shall ensure

that the appropriate conformity assessment procedure has been

carried out by the manufacturer. They shall ensure that the

manufacturer has drawn up the technical documentation, that the

toy bears the required conformity marking and is accompanied by

the required documents, and that the manufacturer has complied

with the requirements set out in regulation 4.

(3) Where an importer considers or has reason to believe that a

toy is not in conformity with the requirements set out in regulation

9 and Schedule I, it shall not place the toy on the market until the

toy has been brought into conformity. Furthermore, where the toy

presents a risk, the importer shall inform the manufacturer and the

Market Surveillance Directorate to that effect.

(4) Importers shall indicate their name, registered trade name

or registered trade mark and the address at which they can be

contacted on the toy itself or, where that is not possible, on its

packaging or in a document accompanying the toy.

(5) Importers shall ensure that the toy is accompanied by

instructions and safety information. All information accompanying

the toy and on the toy itself must be in, at least, the English or

Maltese language.

(6) Importers shall ensure that, while a toy is under their

responsibility, storage or transport conditions do not jeopardise its

compliance with the requirements set out in regulation 9 and

Schedule I.

(7) When deemed appropriate with regard to the risks presented

by a toy, importers shall, to protect the health and safety of

consumers, carry out sample testing of marketed toys, investigate

and keep a register of complaints, of non-conforming toys and toy

recalls, and shall keep distributors informed of any such

monitoring. They shall keep such register at the disposal of the

Market Surveillance Directorate.

(8) Importers who consider or have reason to believe that a toy

which they have placed on the market is not in conformity with the

relevant Community harmonisation legislation shall immediately

take the corrective measures necessary to bring that toy into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the toy presents a risk, manufacturers shall immediately

inform the Market Surveillance Directorate giving details, in

particular, of the non-compliance and of any corrective measures

taken.

(9) Importers shall, for a period of ten years after the toy has

been placed on the market, keep a copy of the EC declaration of

conformity at the disposal of the Market Surveillance Directorate

and ensure that the technical documentation can be made available

to the Directorate upon request.

(10) Importers shall, further to a reasoned request from the

Market Surveillance Directorate, provide that Directorate with all

the information and documentation necessary to demonstrate the

conformity of the toy, in the English or Maltese language. They

shall cooperate with that Directorate, at its request, as regards any

action taken to eliminate the risks posed by toys which they have

placed on the market.

(11) An importer shall be considered as a manufacturer for the

purposes of these regulations and be subject to the obligations of

the manufacturer under regulation 4 when it places a toy on the

market under its name or trademark or modifies a toy already

placed on the market in such a way that compliance with

the applicable requirements may be affected.

7. (1) When making a toy available on the local or

Community market, distributors shall act with due care in relation

to the applicable requirements.

(2) Before making a toy available on the market, distributors

shall verify that the toy bears the required conformity marking, that

it is accompanied by the required documents and by instructions

and safety information in, at least, the English or Maltese language,

and that the manufacturer and the importer have complied with

requirements set out in regulation 4 and regulation 6(4).

(3) Where a distributor considers or has reason to believe that a

toy is not in conformity with the requirements set out in regulation

9 and Schedule I, it shall not make the toy available on the market

until the toy has been brought into conformity. Furthermore, where

the toy presents a risk, the distributor shall inform the manufacturer

or the importer, as well as the Market Surveillance Directorate, to

that effect.

(4) Distributors shall ensure that, while a toy is under their

responsibility, storage or transport conditions do not jeopardise its

compliance with the requirements set out in regulation 9 and

Schedule I.

(5) Distributors who consider or have reason to believe that a

toy which they have made available on the market is not in

conformity with the relevant Community harmonisation legislation,

shall make sure that the corrective measures necessary to bring that

toy into conformity, to withdraw it or recall it, if appropriate, are

taken. Furthermore, where the toy presents a risk, distributors shall

immediately inform the Market Surveillance Directorate giving

details, in particular, of the non-compliance and of any corrective

measures taken.

(6) Distributors shall, further to a reasoned request from the

Market Surveillance Directorate, provide that Directorate with all

the information and documentation necessary to demonstrate the

conformity of the toy. They shall cooperate with that Directorate, at

its request, as regards any action taken to eliminate the risks posed

by toys which they have made available on the market.

(7) A distributor shall be considered as a manufacturer for the

purposes of these regulations and be subject to the obligations of

the manufacturer under regulation 4(1) to (10) when it places a toy

on the market under its name or trademark or modifies a toy

already placed on the market in such a way that compliance with

the applicable requirements may be affected.

8. (1) In addition to the preceding regulations, the economic

operator shall, on request from the Market Surveillance

Directorate, identify

(a) any economic operator who has supplied them with a

toy;

(b) any economic operator to whom they have supplied a

toy.

(2) Manufacturers must be able to present the information

referred to in the preceding sub-regulation for a period of ten years

after the toy has been placed on the market. In the case of other

economic operators, they must be able to present this information

for a period of ten years after they have been supplied with the toy.

9. (1) Only toys complying with the essential safety

requirements set out, as far as the general safety requirement is

concerned, in sub-regulation (5) and, as far as the particular safety

requirements are concerned, in Schedule I and bearing the CE

marking shall be placed on the local or Community market.

(2) Toys placed on the market shall comply with the essential

safety requirements during their foreseeable and normal period of

use.

(3) The making available on the market of toys complying with

these regulations shall not be restricted. Toys bearing the CE

marking shall be presumed to comply with these regulations.

(4) Toys not bearing the CE marking or which do not otherwise

comply with these regulations may be displayed at trade fairs and

exhibitions, provided that they are accompanied by a sign which

clearly indicates that they do not comply with these regulations and

that they will not be made available on the local or Community

market before being brought into conformity.

(5) Toys, including the chemicals they contain, shall not

jeopardise the safety of health of users or third parties when they

are used as intended or in a foreseeable way, bearing in mind the

behaviour of children.

(6) The ability of users and, where appropriate, their

supervisors shall be taken into account, in particular, in the case of

toys which are intended for use by children under thirty-six months

or by other specified age groups.

(7) Labels affixed in accordance with regulation 10(4) to (6)

and instructions for use which accompany toys shall draw the

attention of users or their supervisors to the inherent hazards and

risks of harm involved in using the toys, and to the ways of

avoiding such hazards and risks.

10. (1) Where appropriate for safe use, warnings made for the

purposes of regulation 9(5) to (7) shall specify appropriate user

limitations in accordance with Part A of Schedule VI.

(2) As regards the categories of toys listed in Part B of

Schedule VI, the warnings set out therein shall be used. The

warnings set out in points 2 to 10 of Part B of Schedule VI shall be

used as worded therein.

(3) Toys shall not bear one or more of the specific warnings set

out in Part B of Schedule VI where that warning conflicts with the

intended use of the toy, as determined by virtue of its function,

dimension and characteristics.

(4) The manufacturer shall mark the warnings in a clearly

visible, easily legible and understandable and accurate manner on

the toy, on an affixed label or on the packaging and, if appropriate,

on the instructions for use which accompany the toy. Small toys

which are sold without packaging shall have appropriate warnings

affixed to them.

(5) The warnings shall be preceded by the words "Warning" or

"Warnings", as the case may be.

(6) Warnings which determine the decision to purchase the toy,

such as those specifying the minimum and maximum ages for users

and the other applicable warnings set out in Schedule VI, shall

appear on the consumer packaging or be otherwise clearly visible

to the consumer before the purchase, including in cases where the

purchase is made on-line.

(7) In accordance with regulation 4(8), all warnings and safety

instructions shall be in, at least, the English or Maltese language.

11. (1) The CE marking shall be affixed only by the

manufacturer or his authorised representative.

(2) The CE marking as presented in Schedule X shall be affixed

only to products that fall within the scope of these regulations.

(3) By affixing or having affixed the CE marking, the

m a n u f a c t u r e r i n di c a t e s t h a t h e t a k e s r e s p on s ib i l it y f or t h e

conformity of the toy with all applicable requirements set out in

these regulations and, where applicable, other relevant Community

harmonisation legislation providing for its affixing.

(4) The CE marking shall be the only marking which attests the

conformity of the toy with the applicable requirements of these

regulations.

(5) The affixing to a toy of markings, signs or inscriptions

which are likely to mislead third parties regarding the meaning or

form of the CE marking shall be prohibited. Any other marking

may be affixed to the toy provided that the visibility, legibility and

meaning of the CE marking is not thereby impaired.

(6) The CE marking shall be affixed visibly, legible and

indelibly to the toy, to an affixed label or to the packaging. In case

of small toys and toys consisting of small parts, the CE marking

may alternatively be affixed to a label or an accompanying leaflet.

(7) In the case of toys sold in counter displays, the CE marking

may be affixed to counter displays only when it is not technically

possible to affix the CE marking on the toy itself or on a label or

accompanying leaflet, and on condition that the counter display

was originally used as packaging for the toy.

(8) Where the CE marking is not visible from outside the

p a c k a g i n g , i f a n y, i t s h a l l a s a m i n i m u m b e a ff i x e d t o t h e

packaging.

(9) The CE marking shall be affixed before the toy is placed on

the market. It may be followed by a pictogram or any other mark

indicating a special risk or use.

12. (1) The EC declaration of conformity shall state that the

fulfilment of the requirements set out in regulation 9 and Schedule

I has been demonstrated.

(2) The EC declaration of conformity shall as a minimum

contain the elements specified in Schedule IV and the relevant

modules set out in Schedules VIII to IX and shall be continuously

updated. It shall have the model structure set out in Schedule IV

and shall be in, at least the English or Maltese language.

(3) By drawing up the EC declaration of conformity, the

manufacturer shall assume responsibility for the compliance of the

toy.

13. (1) Toys which are in conformity with harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, shall be

presumed to be in conformity with the requirements covered by

those standards or parts thereof set out in regulation 9 and Schedule

I.

(2) Manufacturers shall, before placing a toy on the local or

Community market, carry out an analysis of the chemical, physical,

mechanical, electrical, flammability, hygiene and radioactivity

hazards that the toy may present, as well as an assessment of the

potential exposure to such hazards.

(3) Before placing a toy on the local or Community market,

manufacturers shall use the conformity assessment procedures

referred to in sub-regulations (4) and (5) to demonstrate that the toy

complies with the requirements set out in regulation 9 and Schedule

I.

(4) If the manufacturer has applied harmonised standards, the

reference number of which has been published in the Official

Journal of the European Union, covering all relevant safety

requirements for the toy, it shall use the internal production control

procedure set out in Schedule VII.

(5) In the following cases, the toy shall be submitted to EC-

type examination, as referred to in sub-regulations (6) to (15),

together with the conformity to type procedure set out in Schedule

IX

(a) where harmonised standards, the reference number of

which has been published in the Official Journal of the

European Union, covering all relevant safety

requirements for the toy, do not exist;

(b) where the harmonised standards referred to in

paragraph (a) exist but the manufacturer has not

applied them or has applied them only in part;

(c) where one or more of the harmonised standards

referred to in paragraph (a) has been published with a

restriction;

(d) when the manufacturer considers that the nature,

design, construction or purpose of the toy necessitate

third party verification.

(6) An application for EC-type examination, performance of

that examination and issue of the EC-type examination certificate

shall be carried out in accordance with the procedures set out in

Schedule VIII.

(7) EC-type examination shall be carried out in the manner

specified in the second indent of point 2 of Schedule VIII.

(8) In addition to those provisions, the requirements laid down

in sub-regulations (9) to (15) shall apply.

(9) The application for an EC-type examination shall include a

description of the toy and an indication of the place of manufacture,

including the address.

(10) When a conformity assessment body notified under

regulation 15 (hereinafter referred to as "notified body") carries out

the EC-type examination, it shall evaluate, if necessary together

with the manufacturer, the analysis of the hazards that toy may

present carried out by the manufacturer in accordance with sub-

regulation (2).

(11) The EC-type examination certificate shall include a

reference to these regulations, a colour image, a clear description of

the toy, including its dimensions, and a list of the tests performed,

together with a reference to the relevant test report.

(12) The EC-type examination certificate shall be reviewed

whenever necessary, in particular in case of a change to the

manufacturing process, the raw materials or the components of the

toy, and, in any case, every five years.

(13) The EC-type examination certificate shall be withdrawn if

the toy fails to comply with the requirements set out in regulation 9

and Schedule I.

(14) Notified bodies shall not grant an EC-type examination

certificate for a toy in respect of which a certificate has been

refused or withdrawn.

(15) When the notified body is established in Malta, the

technical documentation and correspondence relating to the EC-

type examination procedures shall be drawn up in at least, the

English or Maltese language.

(1) The technical documentation referred to in regulation

4(2) shall contain all relevant data or details of the means used by

the manufacturer to ensure that toys comply with the requirements

set out in regulation 9 and Schedule I. It shall, in particular, contain

the documents listed in Schedule V.

(2) The technical documentation shall be drawn up in one of

the official languages of the Community, subject to the requirement

set out in regulation 13(15).

(3) Following a reasoned request from the Market Surveillance

Directorate, the manufacturer shall provide a translation of the

relevant parts of the technical documentation into the English or

Maltese language. When making such a request, the Market

Surveillance Directorate may fix a deadline for receipt of such file

or translation, which shall be thirty calendar days, unless a shorter

deadline is justified in the case of serious and immediate risk.

(4) If the manufacturer does not comply with the requirements

of sub-regulations (1) to (3), the Market Surveillance Directorate

may require it to have a test performed by a notified body at the

manufacturer?fs own expense within a specified period in order to

verify compliance with the harmonised standards and essential

safety requirements.

(1) The Regulatory Affairs Directorate shall notify the

Commission and the other Member States of bodies authorised to

carry out third-party conformity assessment under regulation 13.

(2) The Regulatory Affairs Directorate shall be responsible for

setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies for

the purposes of these regulations, and for the monitoring of notified

bodies, including compliance with regulation 16.

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Regulatory Affairs Directorate shall inform the

Commission of its procedures for the assessment and notification

of conformity assessment bodies and the monitoring of notified

bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (15) and the

Method for Designating Conformity Assessment Bodies

Regulations.

(2)

A conformity assessment body shall be a third party body

independent of the organisation or the toy it assesses. A body

belonging to a business association or professional federation

representing undertakings involved in the design, manufacturing,

provision, assembly, use or maintenance of toys which it assesses,

may, on condition that its independent and the absence of any

conflict of interest are demonstrated, be considered such a body.

(3)

(a) A conformity assessment body, its top level

management and the personnel responsible for carrying

out the conformity assessment tasks shall not be the

designer, manufacturer, supplier, installer, purchaser,

owner, user or maintainer of the toys which they

assess, nor the authorised representative of any of

those parties. Thi s sh al l no t preclude t he use of

assessed toys that are necessary for the operations of

the conformity assessment body or the use of such toys

for personal purposes.

(b) A conformity assessment body, its top level

management and the personnel responsible for

carrying out the conformity assessment tasks shall not

be directly involved in the design or manufacture, the

marketing, installation, use or maintenance of those

toys, or represent the parties engaged in those

activities. They shall not engage in any activity that

may conflict with their independence of judgement or

integrity in relation to conformity assessment

activities for which they are notified. This shall in

particular apply to consultancy services.

(c) Conformity assessment bodies shall ensure that the

activities of their subsidiaries or subcontractors do not

affect the confidentiality, objectivity or impartiality of

their conformity assessment activities.

(4) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest

degree of professional integrity and the requisite technical

competence in the specific field and shall be free from all pressures

and inducements, particularly financial, which might influence

their judgement or the results of their conformity assessment

activities, especially as regards persons or groups of persons with

an interest in the results of those activities.

(5)

(a) Conformity assessment bodies shall be capable of

carrying out the conformity assessment tasks assigned

to them by the provisions of regulation 13 and in

relation to which they have been notified, whether

those tasks are carried out by the conformity

assessment body itself or on its behalf and under its

responsibility.

(b) At all times and for each conformity assessment

procedure and each kind or category of toy in relation

to which it has been notified, a conformity assessment

body shall have at its disposal the necessary

(i)

personnel

with

technical

knowledge

and

sufficient and appropriate experience to perform

the conformity assessment tasks;

(ii) descriptions of procedures in accordance with

which conformity assessment is carried out

ensuring the transparency and ability of

reproduction of those procedures. It shall have

appropriate policies and procedures in place that

distinguish between tasks it carries out as a

notified body and other activities;

(iii) procedures for the performance of activities

which take due account of the size of an

undertaking, the sector in which it operates, its

structure, the degree of complexity of the

technology of the toy in question and the mass or

serial nature of the production process.

(c) A conformity assessment body shall have the means

necessary to perform the technical and administrative

tasks connected with the conformity assessment

activities in an appropriate manner and shall have

access to all necessary equipment or facilities.

(6) The personnel responsible for carrying out the conformity

assessment activities shall have

(a) sound technical and vocational training covering all

the conformity assessment activities in relation to

which the conformity assessment body has been

notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to

carry out those assessments;

(c) appropriate knowledge and understanding of the

essential requirements, of the applicable harmonised

standards and of the relevant Community

harmonisation legislation and of its implementing

regulations;

(d) the ability to draw up certificates, records and reports

demonstrating that assessments have been carried out.

(7) The impartiality of conformity assessment bodies, their top

level management and assessment personnel shall be ensured. The

r e m u ne r a t i o n o f t he to p l e v el m a n a ge m e n t an d a s s e s s m e n t

personnel of a conformity assessment body shall not depend on the

number of assessments carried out or on the results of those

assessments.

(8) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance

with its national law, or the State itself is directly responsible for

the conformity assessment.

(9) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information

obtained in carrying out their tasks under regulation 13 or any

provision of national law, except in relation to the Regulatory

Affairs in which its activities are carried out. Proprietary rights

shall be protected.

(10) Conformity assessment bodies shall participate in, or

ensure that their assessment personnel are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under regulation 18(8), and shall

apply as general guidance the administrative decisions and

documents produced as a result of the work of that group.

(11) Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, it shall be

presumed to comply wit h the requirem ents set out in these

regulations insofar as the applicable harmonised standards cover

those requirements.

(12) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a

subsidiary, it shall ensure that the subcontractor or the subsidiary

meets the requirements set out in these regulations, and shall

inform the Regulatory Affairs Directorate accordingly.

(13) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries, wherever these are

established.

(14) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(15) Notified bodies shall keep at the disposal of the Regulatory

Aff a i rs D ir e c t o ra te t he r e l e v a n t do c u m e n ts co nc e r ni ng th e

assessment of the qualifications of the subcontractor or the

subsidiary and the work carried out by them under regulation 13.

(1) A conformity assessment body established in Malta

shall submit an application for notification under these regulations

to the Regulatory Affairs Directorate.

(2) The application referred to in the preceding sub-regulation

shall be accompanied by a description of the conformity assessment

activities, the conformity assessment module or modules and the

toy or toys for which that body claims to be competent, as well as

by an accreditation certificate, where one exists, issued by the

National Accreditation Board (Malta) attesting that the conformity

assessment body fulfils the requirements laid down in regulation 16

and the Method for Designating Conformity Assessment Bodies

Regulations.

(3) Where the conformity assessment body concerned cannot

provide an accreditation certificate, it shall provide the Regulatory

Affairs Directorate with the documentary evidence necessary for

the verification, recognition and regular monitoring of its

compliance with the requirements laid down in regulation 16.

(4) The Regulatory Affairs Directorate may only notify

conformity assessment bodies which have satisfied the

requirements laid down in regulation 16 and the Method for

Designating Conformity Assessment Bodies Regulations.

(5) The Regulatory Affairs Directorate shall notify conformity

assessment bodies to the Commission and the other Member States

using the electronic notification tool developed and managed by the

Commission.

(6) The notification shall include full details of the conformity

assessment activities, the conformity assessment module or

modules, toy or toys concerned and the relevant attestation of

competence.

(7) The body concerned may perform the activities of a notified

body only where no objections are raised by the Commission or the

other Member States within two weeks of a notification. Only such

a body shall be considered a notified body for the purposes of these

regulations.

(8) The Regulatory Affairs Directorate shall notify the

Commission and the other Member States of any subsequent

relevant changes to the notification.

(9) Where the Regulatory Affairs Directorate has ascertained

or has been informed that a notified body no longer meets the

requirem ents laid down in regulation 16 or the Met hod for

Designating Conformity Assessment Bodies Regulations, or that it

is failing to fulfil its obligations, the Regulatory Affairs Directorate

shall restrict, suspend or withdraw notification as appropriate,

depending on the seriousness of the failure to meet those

requirements or fulfil those obligations. It shall immediately inform

the Commission and the other Member States accordingly.

(10) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Regulatory Affairs Directorate shall take appropriate steps to

ensure that the files of that body are either processed by another

notified body or kept available to the responsible notifying and

market surveillance authorities, at their request.

(11) The Regulatory Affairs Directorate shall provide the

Commission, on request, with all information relating to the basis

for the notification or the maintenance of the competence of the

body concerned.

(1) Notified bodies shall carry out conformity assessments

in accordance with the conformity assessment procedure provided

for in regulation 13.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators. Conformity assessment bodies shall perform their

activities taking due account of the size of an undertaking, the

sector in which it operates, its structure, the degree of complexity

of the technology of the toy in question and the mass or serial

nature of the production process. In so doing, they shall

nevertheless respect the degree of rigour and the level of protection

required for the compliance of the toy with these regulations.

(3)

Where a notified body finds that the requirements set out in

regulation 9 and Schedule I or in corresponding harmonised

standards have not been met by a manufacturer, it shall require that

manufacturer to take appropriate corrective measures and shall not

issue the EC -type ex amination certificate as re ferred to in

regulation 13.

(4) Where, in the course of the monitoring of conformity

following the issue of a EC-type examination certificate, a notified

body finds that a toy is no longer in compliance, it shall require the

manufacturer to take appropriate corrective measures, and shall

suspend or withdraw the EC-type examination certificate if

necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or

withdraw any EC-type examination certificates, as appropriate.

(6) Notified bodies shall inform the Regulatory Affairs

Directorate of the following

(a) any refusal, restriction, suspension or withdrawal of an

EC-type examination certificate;

(b) any circumstances affecting

the

scope

of

and

conditions for notification;

(c) any request for information which they have received

from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification, and

any other activity performed, including cross-border

activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified

under these regulations or under Directive 2009/48/EC which carry

out similar conformity assessment activities covering the same toys

with relevant information on issues relating to negative and, on

request, positive conformity assessment results.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the

Commission.

(1) Where the Regulatory Affairs Directorate considers

that a harmonised standard does not entirely satisfy the

requirements which it covers and which are set out in regulation 9

and Schedule I, it shall bring the matter before the Committee set

up by Article 5 of Directive 98/34/EC, giving its arguments.

(2) Where the Regulatory Affairs Directorate has a formal

objection to the harmonised standards referred to in regulation

16(1) shall apply.

(1) When the Market Surveillance Directorate takes

measures as provided for in these regulations, and in particular

those referred to in sub-regulation (2), it shall take due account of

the precautionary principle.

(2) The Market Surveillance Directorate shall organise and

perform surveillance of toys placed on the market in accordance

with Articles 15 to 29 of Regulation (EC) No 765/2008. In addition

to those Articles, sub-regulations (3) to (5) shall apply.

(3) The Market Surveillance Directorate may request a notified

body to provide information relating to any EC-type examination

certificate which that body has issued or withdrawn, or which

relates to any refusal to issue such a certificate, including the test

reports and technical documentation.

(4) Where the Market Surveillance Directorate finds that a toy

is not in conformity with the requirements set out in regulation 9

and Schedule I, it shall, where appropriate, instruct the notified

body to withdraw the EC-type examination certificate in respect of

that toy.

(5) Where necessary, and in particular in the cases specified in

the regulation 13(12), the Market Surveillance Directorate shall

instruct the notified body to review the EC-type examination

certificate.

(6) Where the Market Surveillance Directorate has taken action

pursuant to Article 20 of Regulation (EC) No 765/2008, or where it

has sufficient reason to believe that a toy covered by these

regulations presents a risk to the health or safety of persons, it shall

carry out an evaluation in relation to the toy concerned covering all

the requirements laid down in these regulations. The relevant

economic operators shall cooperate as necessary with the Market

Surveillance Directorate.

(7)

(a) Where, in the course of that evaluation, the Market

Surveillance Directorate finds that the toy does not

comply with the requirements laid down in these

regulations, it shall without delay require the relevant

economic operator to take appropriate corrective action

to bring the toy into compliance with those

requirements, to withdraw the toy from the market, or

to recall it within a reasonable period, commensurate

with the nature of the risk, as they may prescribe.

(b) The Market Surveillance Directorate shall inform the

relevant notified body accordingly.

(c) Article 21 of Regulation (EC) No 765/2008 shall apply

to the measures referred in the preceding paragraph.

(8) Where the Market Surveillance Directorate considers that

non-compliance is not restricted to the local territory, it shall

inform the Commission and the other Member States of the results

of the evaluation and of the actions which they have required the

relevant economic operator to take.

(9) The relevant economic operator shall ensure that

appropriate corrective action is taken in respect of toys which that

operator has made available on the local or Community market.

(10) (a) Where the relevant economic operator does not take

adequate corrective action within the period referred to

in the second sub-paragraph of sub-regulation (7), the

Market Surveillance Directorate shall take appropriate

provisional measures to prohibit or restrict the toy

being made available on the local market, to withdraw

the toy from that market or to recall it.

(b) The Market Surveillance Directorate shall inform the

Commission and the other Member States, without

delay, of those measures.

(11) The information referred to in sub-regulation (10) shall

include all available details, in particular the data necessary for the

identification of the non-compliant toy, the origin of the toy, the

nature of the alleged non-compliance and the risk involved, the

nature and duration of the national measures taken and the

arguments put forward by the relevant economic operator. In

particular, the Market Surveillance Directorate shall indicate

whether the non-compliance is due to either

(a) failure of the toy to meet requirements relating to the

health or safety of persons; or

(b) shortcomings in the harmonised standards referred to

in regulation 13(1) conferring a presumption of

conformity.

(12) Where market surveillance procedures are initiated in

another Member State other than Malta, the Market Surveillance

Directorate shall without delay inform the Commission and the

other Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of the

toy concerned, and, in the event of disagreement with the notified

national measure, of their objections.

(13) Where, within three months of receipt of the information

referred to in sub-regulation (10), no objection has been raised by

e i t h e r a M e m b e r St a t e o r t h e C o m m i s s i o n i n r e s p e c t o f a

provisional measure taken by the Market Surveillance Directorate,

that measure shall be deemed to be justified.

(14) The Market Surveillance Directorate shall take appropriate

restrictive measures in respect of the toy concerned, such as

withdrawal of the toy from their market, without delay.

(15) Where, on completion of the procedure set out in sub-

regulations (9) and (10), the national measure is considered

justified, irrespective of whether the national measure was initiated

in Malta or in another Member State, the Market Surveillance

Directorate shall take the measures necessary to ensure that the

non-compliant toy is withdrawn from their market, and shall inform

the Commission accordingly.

(16) Where the national measure is considered unjustified by the

Commission, the Market Surveillance Directorate shall withdraw it.

(17) If a measure referred to in sub-regulation (10) is a type of

measure which is required under Article 22 of Regulation (EC) No

765/2008 to be notified through the Community Rapid Information

Exchange System, it shall not be necessary to make a separate

notification under sub-regulation (10), provided that the following

conditions are met

(a) the Community Rapid Information Exchange

notification indicates that the notification of the

measure is also required by these regulations;

(b) the supporting evidence referred to in sub-regulation

(11) is enclosed with the Community Rapid

Information Exchange notification.

(18) Without prejudice to sub-regulations (6) to (14), where the

Market Surveillance Directorate makes one of the following

findings, it shall require the relevant economic operator to put an

end to the non-compliance concerned

(a) that the CE marking has been affixed in violation of

regulations 9 or 11;

(b) that the CE marking has not been affixed;

(c) that the EC declaration of conformity has not been

drawn up;

(d) that the EC declaration of conformity has not been

drawn up correctly;

(e) that technical documentation is either not available or

not complete.

(19) Where the non-compliance referred to in sub-regulation

(18) persists, the Market Surveillance Directorate shall take

appropriate measures to restrict or prohibit the toy being made

available on the market, or shall ensure that it is recalled or

withdrawn from the market.

(20) By the 20th July 2014 and every five years thereafter, the

Market Surveillance Directorate shall send the Commission a

report on the application of these regulations. That report shall

contain an evaluation of the situation concerning the safety of toys

a n d o f t h e e ff e c t i v e n e s s o f t h e s e r e g u l a t i o n s , a s w e l l a s a

presentation of the market surveillance activities performed by the

Market Surveillance Directorate.

(21) When the Market Surveillance Directorate adopts measures

under these regulations, the requirements of transparency and

confidentiality provided for in article 22 of the Act shall apply.

(22) (a) Any measure taken pursuant to these regulations to

prohibit or restrict the placing on the market of a toy,

to withdraw a toy or to recall a toy from the market

shall state the exact grounds on which it is based.

(b) Such a measure shall be notified without delay to the

party concerned, which shall at the same time be

informed of the remedies available to it under local

laws and of the time limits applicable to them.

The penalties applicable for the infringement of any of the

provisions above shall be those provided for in Part IV of the Act.

References to the Safety of Toys Regulations, 2002, * shall

be construed as references to these regulations.

*Revoked by these regulations.

5

9.4

Chromium (VI)

0.02

0.005

0.053

Cobalt

10.5

2.6

Copper

622.5

Lead

2,0

0,5

Manganese

15000

Mercury

7.5

1.9

Nickel

18.8

Selenium

37.5

9.4

Strontium

56000

Tin

15000

180000

Organic tin

0.9

0.2

Zinc

46000

These limit values shall not apply to toys or components of toys which, due to

their accessibility, function, volume or mass, clearly exclude any hazard due to

sucking, licking, swallowing or prolonged contact with skin when used as specified

in regulation 9(5).

V.

Electrical Properties

(1)

(a) Toys shall not be powered by electricity of a nominal voltage exceeding

24 volts direct current (DC) or the equivalent alternating current (AC)

voltage, and their accessible parts shall not exceed 24 volts DC or the

equivalent AC voltage.

(b) Internal voltages shall not exceed 24 volts DC or the equivalent AC

voltage unless it is ensured that the voltage and the current combination

generated do not lead to any risk or harmful electric shock, even when

the toy is broken.

(2) Parts of toys which are connected to, or liable to come into contact with, a

source of electricity capable of causing electric shock, together with the cables or

other conductors through which electricity is conveyed to such parts, must be

properly insulated and mechanically protected so as to prevent the risk of such

shock.

(3) Electric toys must be designed and manufactured in such a way as to ensure

that the maximum temperatures reached by all directly accessible surfaces are not

such as to cause burns when touched.

(4) Under foreseeable fault conditions, toys must provide protection against

electrical hazards arising from an electrical power source.

(5)

Electric toys must provide adequate protection against fire hazards.

(6) Electric toys must be designed and manufactured in such a way that electric,

magnetic and electromagnetic fields and other radiations generated by the equipment

are limited to the extent necessary for the operation of the toy, and must operate at a

safe level in compliance with the generally acknowledged state of the art, taking

account of specific local or Community measures.

(7) Toys which have an electronic control system must be designed and

manufactured in such a way that the toy operates safely even when the electronic

system starts malfunctioning or fails due to failure of the system itself or an outside

factor.

(8) Toys must be designed and manufactured in such a way that they do not

present any health hazards or risk of injury to eyes or skin from lasers, light-emitting

diodes (LEDs) or any other type of radiation.

(9)

The electrical transformer of a toy shall not be an integral part of the toy.

VI.

Hygiene

(1) Toys must be designed and manufactured in such a way as to meet hygiene

and cleanliness requirements in order to avoid any risk of infection, sickness or

contamination.

(2) A toy intended for use by children under 36 months must be designed and

manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be

washable, except if it contains a mechanism that may be damaged if soak washed.

The toy shall fulfil the safety requirements also after having been cleaned in

accordance with this point and the manufacturer’s instructions.

VII. Radioactivity

Toys shall comply with all relevant measures adopted under Chapter III of the

Treaty establishing the European Atomic Community.