MT
Safety of Toys Regulations, 2011
Table of Provisions (26)
Statutory Text (26 Articles)
Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,707, 11 ta’ Frar, 2011
L.N. 50 of 2011
PRODUCT SAFETY ACT
(CAP. 427)
Safety of Toys Regulations, 2011
IN exercise of the powers conferred by article 38 of the
Product Safety Act, the Prime Minister, on the advice of the Malta
Standards Authority, has made the following regulations:-
(1) The title of these regulations is the Safety of Toys
Regulations, 2011.
(2) These regulations transpose Directives 88/378/
EEC, 2008/112/EC and 2009/48/EC and lay down rules on the
safety of toys and on their free movement in the Community.
(3) These regulations shall enter into force on the 20th
July 2011.
(4) The Act shall apply to toys in accordance with
article 5 thereof.
(5) The making available on the local or Community
market of toys which are in accordance with the Safety of
Toys Regulations, 2002, and which were placed on the local
or Community market before the 20th July 2011, shall not be
restricted.
(1) These regulations shall apply to products designed
or intended, whether or not exclusively, for use in play by children
under 14 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;
(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 14 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, public highways, or the pavement thereof;
(k) Aquatic equipment intended to be used in deep
water, and swimming learning devices for children, such as
swim seats and swimming aids;
(l) Puzzles with more than 500 pieces;
(m) Guns and pistols using compressed gas, with
the exception of water guns and water pistols, and bows for
archery over 120cm long;
(n) Fireworks, including percussion caps, which are
not specifically designed for toys;
(o) Products and games using sharp-pointed missiles,
such as sets of darts with metallic points;
(p) 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;
(q) Products intended for use for educational
purposes in schools and other pedagogical contexts under the
surveillance of an adult instructor, such as science equipment;
(r) 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;
(s) Interactive software, intended for leisure and
entertainment, such as computer games, and their storage
media, such as CDs;
(t) Babies’ soothers;
(u) Child-appealing luminaries;
(v) Electrical transformers for toys;
(w) Fashion accessories for children which are not for
use in play.
For the purposes of these regulations, the following
definitions shall apply
“accreditation” shall have the meaning assigned to it by
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, 2003, 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, 2003, 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 Establishment of Directorates of the Malta
Standards Authority Order, 2008;
“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, 2007;
“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 Establishment of Directorates of the Malta
Standards Authority Order, 2008;
“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;
(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 13.
(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.
(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 10 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) Cooperate with the Market Surveillance
Directorate, at its request, as regards any action taken to
eliminate the risks posed by toys covered by the mandate.
(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.
(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 regulations 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.
(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.
(1) Only toys complying with the essential safety
requirements set out, as far as the general safety requirement is
concerned, in regulation 9(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 36 months or by
other specified age groups.
(7) Labels affixed in accordance with regulations 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.
(1) Where appropriate for safe use, warnings made Warnings.
for the purposes of regulations 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 to these regulations, 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.
(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 manufacturer indicates that he takes responsibility for the
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 packaging, if any, it shall as a minimum be affixed to the
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.
(1) The EC declaration of conformity shall state EC declaration of
that the fulfilment of the requirements set out in regulation 9 and conformity.
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.
(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
(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 30 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’s 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, 2003.
(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. This shall not preclude the 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 remuneration of the top level management and
assessment 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 ) W h e r e a c o n f o r m i t y a s s e s s m e n t b o d y
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 with the requirements
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 Affairs Directorate the relevant documents concerning
the 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, 2003.
(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, 2003.
(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 requirements laid down in regulation 16 or the Method
for Designating Conformity Assessment Bodies Regulations, 2003,
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 examination certificate as referred
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, sub-regulation (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 sub-
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 regulation 20(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 either a Member State or the Commission in
respect of 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 and of the effectiveness of these regulations, as well
as 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.
The Safety of Toys Regulations, 2002, are being
2002. revoked.
References to the revoked regulations shall be construed
as references to these regulations.
B
Schedule I
PARTICULAR SAFETY REQUIREMENTS
(Regulation 9)
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 36 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 points (e) and (f), which is spherical, egg-
shaped 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 points (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.
Flammability
B
(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 20 th July 2011 until the 31 st 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, 2009.
Criteria to be applied as from the 1 st June 2015
(b)
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.
Chemical Properties applicable as from the 20 th July 2011 until the 19 th July
(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
B
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)
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, 2007, 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, 2009, 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 20 th 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, 2009, the Dangerous Substances and Preparations
Regulations, 2007, 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 of toys.
(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
B
(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
As from the 20 th July 2011 until the 31 st May 2015, the relevant
(a)
concentrations for the classification of mixtures containing the substances
shall be those established in accordance with the Dangerous Substances
and Preparations Regulations, 2007.
As from the 1 st June 2015, the relevant concentrations for the classification
(b)
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 20 st July 2011 until the 31 st 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, 2009, and the Dangerous Substances and
Preparations Regulations, 2007, as applicable.
As from the 1 st 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 20 th July 2011 until the 31 st May 2015, point 5 concerns
mixtures classified as CMR category 3 under the Classification, Labelling
and Packaging of Substances and Mixtures (CLP) (Implementation)
Regulations, 2009, and the Dangerous Substances and Preparations
Regulations, 2007, as applicable.
As from the 1 st 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 20 th 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
B
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, 2004.
(13)
Toys shall not contain the following allergenic fragrances
Name of the allergenic fragrance
CAS Number
Alanroot oil (Inula helenium)
97676-35-2
Allylisothiocyanate
57-06-7
Benzyl Cyanide
140-29-4
4 tert-Butylphenol
98-54-4
Chenopodium oil
8006-99-3
Cyclamen alcohol
4756-19-8
Diethyl maleate
141-05-9
Dihydrocoumarin
119-84-6
2,4-Dihydroxy-3-methylbenzaldehyde
6248-20-0
3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)
40607-48-5
4,6-Dimethyl-8-tert-butylcoumarin
17874-34-9
Dimethyl citraconate
617-54-9
7,11-Dimethyl-4.6,10-dodecatrien-3-one
26651-96-7
6,10-Dimethyl-3.5,9-undecatrien-2-one
141-10-6
Diphenylamine
122-39-4
Ethyl acrylate
140-88-5
Fig leaf, fresh and preparations
68916-52-9
trans-2-Heptenal
18829-55-5
trans-2-Hexenal diethyl acetal
67746-30-9
trans-2-Hexenal dimethyl acetal
18318-83-7
Hydroabietyl alcohol
13393-93-6
4-Ethoxy-phenol
622-62-8
6-lsopropyl-2-decahydronaphthalenol
34131-99-2
7-Methoxycoumarin
531-59-9
4-Methoxyphenol
150-76-5
4-(p-Methoxyphenyl)-3-butene-2-one
943-88-4
1-(p-Methoxyphenyl)-1-penten-3-one
104-27-8
Methyl trans-2-butenoate
623-43-8
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
8007-00-9
pereirae (Royle) 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-
83-66-9
dinitrotoluene)
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-
31906-04-4
methylpentylcyclohexenecarboxaldehyde
Isoeugenol
97-54-1
Oakmoss extracts
90028-68-5
Treemoss extracts
90028-67-4
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
Name of the allergenic fragrance
CAS Number
Anisyl alcohol
105-13-5
Benzyl benzoate
120-51-4
Benzyl cinnamate
103-41-3
Citronellol
106-22-9
Farnesol
4602-84-0
Hexyl cinnamaldehyde
101-86-0
Lilial
80-54-6
d-Limonene
5989-27-5
Linalool
78-70-6
Methyl heptine carbonate
111-12-6
3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-
127-51-5
3-buten-2-one
(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,
B
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, 2004; 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 liquid or
mg/kg in scraped-
brittle, powder-
sticky toy
off toy material
like or pliable toy
material
material
Aluminium
70000
Antimony
11.3
3.8
0.9
56000
15000
Cadmium
1.9
0.5
Chromium (III)
5
9.4
Chromium (VI)
0.02
0.005
0.2
10.5
2.6
622.5
13.5
3.4
Manganese
15000
7.5
1.9
18.8
Selenium
37.5
9.4
Strontium
56000
15000
180000
Organic tin
0.9
0.2
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).
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.
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.
B
(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.
Radioactivity
Toys shall comply with all relevant measures adopted under Chapter III of the
Treaty establishing the European Atomic Community.
B
Schedule II
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 stainless steel
B
Schedule III
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)
Schedule IV
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’s 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.
B
Schedule V
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).
Schedule VI
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.
B
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 ( 1 ) 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
1 Age to be specified by the manufacturer.
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’.
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’.
B
Schedule VII
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 responsibility 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
legislative instrument to each individual toy that 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 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.
B
Schedule VIII
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’s 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;
b) 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;
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
B
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-à 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.
B
Schedule IX
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.
Schedule X
CE-MARKING
(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.
€2.61