Consumers

Regulation No 408/1994 on the Safety of Toys and Dangerous Imitations





Translated from the Icelandic

REGULATION

on the Safety of Toys
and Dangerous Imitations


(A consolidated version of regulation No. 408/1994
of 12 July 1994 and regulation No. 293/1995 of 15 may 1995
amending regulation No. 408/1994)


CHAPTER I
Scope
Article 1

This Regulation applies to toys which are clearly designed for use in play by children of less than 14 years of age. It also applies to products which, although not foodstuffs, possess a form, odour, colour, appearance, packaging, labelling, volume or size, such that it is likely that consumers, especially children, will confuse them with foodstuffs and in consequence place them in their mouths, or suck or ingest them.
For the purposes of this Regulation the products listed in Annex I to this Regulation are not considered toys.

CHAPTER II
Definitions
Article 2

Party responsible shall mean a party responsible for marketing toys and/or imitations in this country. The party responsible can be a producer or an importer. The party responsible has certain obligations beyond other suppliers.
A CE marking symbolizes that a product conforms to all defined essential requirements in regulations and harmonized standards. Council Decision 93/465/EEC provides for the type and usage of the marking.
Chemical toys shall mean toys such as chemistry sets or plastic embedding sets, miniature workshops for ceramics, enamelling or photography and similar toys.
Imitation shall mean a product likely to be confused with foodstuffs because it
seems to differ from what it is.
Accreditation shall mean a method applied by the certification department of the Icelandic Metrology and Accreditation Secvice to grant a formal approval to parties when they are qualified to do certain undertakings in accordance with rules in force.
Producer shall mean the manufacturer of the product and any other person presenting himself as the manufacturer by affixing to the product his name, trade mark or other distinctive mark. A producer can also be a person who reconditions the product or acts as the manufacturer's representative established in the European Economic Area, when the manufacturer is not established in this area. Pcoducer can also mean other parties in the supply chain of a product who have manufactured components which may affect safety properties of a product.
Market surveillance shall mean an effective and organized supervision of products on the macket. Market surveillance is divided into market inspection on the one hand and indirect surveillance through sources of information and complaints on the other hand, inter alia by receiving notifications concerning products which are considered dangerous. The market surveillance shall be carried out by an accredited inspection body.
Market inspection shall mean an examination of a product and determination as to whether it meets the special or general requirements. The conformity of a product is assessed according to fixed and defined operating procedures.
Consumer shall mean a person who purchases a product and uses it.
Functional toys shall mean toys which are used in the same way as appliances or installations intended for adults.
Harmonized standard shall mean a standard drawn up in accordance with essential requirements and approved by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), on mandates given by the European Union and the European Free Trade Association.
Declaration of conformity shall mean a declaration by the producer that he certifies that a product, process or service complies with standards and other required documents.
Cooperation committee shall mean the body for cooperation between the Icelandic Metrology and Accreditation. Service and an accredited inspection body responsible for the implementation of the market inspection.
Supplier shall mean the manufacturer of the product, the manufacturer's representative, importer, intermediary at later stages, distributor and retailer.
Notified body shall mean a testing laboratory, certification body or accredited inspection body appointed by competent authorities to supervise conformity assessment according to a European Union directive and an agreement between the member states of the European Free Trade Association on Mutual approval of test results and verification of conformity from 15 June 1988 (The Tampere Agreement).
Product shall mean any product offered to consumers for consideration or not, in the course of a commercial activity of a supplier, whether new, used or reconditioned. However, this shall not apply to second-hand products supplied as antiques or products to be repaired or reconditioned prior to being used, provided that the supplier clearly informs the person to whom he supplies the product to that effect before the business transaction takes place or the purchaser becomes aware of this.
Safe product shall mean any product which, under normal or reasonably foreseeable conditions of use, meets the requirements made in public interest in respect of safety, protection of health and the environment.

CHAPTER III
Safety of Toys and Imitations
Article 3

Toys may not be placed on the market in Iceland neither as a present or as a purchase, if they jeopardize the safety and/or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the normal behaviour of children. Furthermore, parties established in Iceland may not place such toys on the market in other states within the European Economic Area.
In the condition in which they are placed on the market, taking account of the period of foreseeable and normal use, toys must meet the safety and health conditions laid down in Annex II to this Regulation.

Article 4

Toys may not be placed on the market unless they are either designed or produced according to harmonized European standards or designed or produced in accordance with a model which has been granted type approval by the notified body within the European Economic Area. The producer shall declare that a toy has fulfilled all the requirements of the Regulation with a declaration of conformity. If a toy is marked with a CE-mark it shall be regarded as fulfilling the requirements of this regulation.
Annex III to this Regulation includes references to the relevant standards.

Article 5

The Minister of Commerce can nominate one or more testing laboratories as notified bodies in the field of toys and give them a mandate to grant type approvals for toys according to the provisions of the Regulation. The appointment can be subject to conditions and restrictions.
A notified body must have been granted an accreditation in accordance with relevant standards in the standard series ÍST EN 450 XX. Annex VII to this Regulation includes further conditions to be fulfilled by the notified body.
Annex IV to this Regulation includes the methods used by the producer to prepare the declaration of conformity.

Article 6

The party responsible for the manufacture of toys in accordance with European harmonized standards must be able to submit the information referred to in Annex V to this Regulation.
The party responsible for type approved toys must be able to submit the information referred to in Annex VI to this Regulation.
The party responsible is required to keep a record on the parties responsible for the products he has on offer as well as having at hand copies of certificates, technical documents and declarations of conformity as appropriated. These documents shall be kept for at least ten years after the last model of the production has been put on the market.

Article 7

Toys may be placed on the market only if the CE-mark is affixed to them. A warning shall be placed on the toy itself or in the instructions for use on the dangers that particular toys may entail as well as information on how to respond to such dangers. The toy must also be marked with the name of the producer and his trade name or mark as well as his address or the name and trade name or trade mark of a party responsible as well as his address. These particulars shall be affixed either to the toy or on the packaging in a visible, easily legible and indelible form. In the case of small toys and toys consisting of small parts these particulars may appear in the same way on the label or in the instructions for use. The affixing to toys of marks or inscriptions that are likely to be confused with the CE-mark shall be prohibited.
The particulars referred to in paragraph 1 may be abbreviated provided that the abbreviation enables the manufacturer or party responsible to be identified.
In addition to the particulars referred to in paragraph l, warnings and indications of precautions to be taken during use shall be accompanied by the following toys:
l. Toys which can be dangerous to children younger than three years old shall be marcked with a warning as well as an indication of the particular danger involved. This provision does not apply to toys which, on account of their function, dimensions, characteristics, properties or other apparent grounds, are manifestly unsuitable for children under three years of age.
2. Slides, suspended swings and rings, trapezes, ropes and similar toys attached to a crossbeam shall be accompanied by instructions on their correct assembly, indicating those parts which can present dangers if it is incorrectly assembled. In addition, it shall be accompanied by information on necessary checks and maintenance of the main parts and pointing out that if these checks are not carried out, the toy may cause a fall or overturn.
3. The packaging of functional toys shall bear warnings indicating that they shall be used under the direct supervision of an adult. In addition they shall be accompanied by precautions to be taken by the user, with the warning that failure to take these precautions would expose the user to hazards. It will also be indicated that the toy must be kept out of the reach of children younger than three years of age.
4. Toys containing dangerous substances or preparations and chemical toys shall be accompanied by precautions, indication of a special risks and an indication of first aid to be given in the event of accident as well as marking in accordance with a regulation on the classification, marking and handling of toxic and dangerous substances. In addition, it shall also be pointed out that the toy must be kept out of reach of children younger than three years of age. In addition, the packaging of chemical toys shall bear a warning stating that the toy is only meant for children belonging to an age group which will be more accurately provided for in relevant standards and that it shall be used under supervision of adults
5. Skateboards and roller skates for children shall bear a marking warning users that a protective equipment should be worn. The instructions for use shall contain a reminder that the toy must be used with caution and some indications shall be given as to recommended protective equipment. The party responsible is required to inform the buyer of a toy of the importance of keeping such instructions if they are not attached to the toy.
6. Toys intended for use in water, cf. Annex II Chapter II.1 item f to this regulation, shall, according to harmonized European standards, bear a warning stating that they may only be used in water in which the child is within its depth and under supervision.
All warnings shall be in the Icelandic language.

Article 8

It is prohibited to import, produce or market products in Iceland which, appearing to be other than they are, can be confused with foodstuffs and thus jeopardize the health or safety of consumers and, although not foodstuffs, possess a form, odour, colour, appearance, packaging, labelling, volume or size, such that it is likely that consumers, especially children, will confuse them with foodstuffs and in consequence place them in their mouths, or suck or ingest them, which might be dangerous and cause, for example, suffocation, poisoning, or the perforation or obstruction of the digestive tract. In addition, parties established in Iceland are prohibited to place such products on the market in other states within the European Economic Area.

CHAPTER IV
Official Market Control of Toys and Imitations
Article 9

With official market control an effort shall be made to ascertain that toys and imitations on the market meet the rules in.force and do not entail danger.
The Icelandic Metrology and Accreditation Service exercises the administrative part of market control and the inspection body is in charge of the market control. The cooperation between the Icelandic Metrology and Accreditation Service and the inspection body takes place within a cooperation committee.

Article 10

The function of the Icelandic Metrology and Accreditation Service in official market control of toys and imitations is as follows:
1. To formalize a general policy on priorities in market surveillance and on the extent of the monitoring of the market and to lay down procedures.
2. To manage the contracting of inspection laboratories and to cover costs pertaining to such contracts.
3. To give rulings in individual cases once a cooperation committee has dealt with them and submitted its proposal.

Article 11

Market surveillance shall be carried out by an inspection body which has been accredited according to Regulation No. 346/1993 on the Operations of Accredited and Independent Inspection Bodies. The inspection body is responsible for market inspection, seeks in an organized manner information on products on the market and receives complaints and indications from consumers and other parties. One or more inspection bodies shall be contcacted to implement the market surveillance.

Article 12

A cooperation committee discusses programs of operation in market surveillance, remarks made on particular products and product categories and submits proposals on administrative action to a surveillance authority, which then takes the final decision.
The Minister of Commerce appoints a cooperation committee consisting of three members. One of the members of the committee shall be a representative from the Icelandic Metrology and Accreditation Service, one from the inspection body. Representatives from the Environmental and Food Agency of Iceland and The State Electrical Inspection shall be called to attend the committee's meetings when dealing with specialized subjects in the field of work of these institutions.

CHAPTER V
Market Surveillance
Article 13

An inspection body is authorized to inspect products located at supplier's premises and to require relevant information on the party responsible, as well as to take product samples for examination. The inspection body can require that the party responsible submit a certificate, declaration of conformity to rules and standards, test report, technical data and other relevant information to prove the safety of a product.
The employees of the Icelandic Metrology and Accreditation Service, the inspection body and the representatives in the cooperation committee are sworn to professional secrecy on matters revealed in the course of the examination which are protected by commercial secrecy. However, in case of urgency this shall not hinder the public disclosure of information on dangerous toys and dangerous imitations if the product endangers the safety and health of users and the environment.

CHAPTER VI
Administrative Action
Article 14

If toys or imitations do not meet the formal requirements on labelling, instructions, certificates, declarations of conformity, test reports, etc., the Icelandic Metrology and Accreditation Service can prohibit its sale.
If a party responsible inhibits the inspection or examination of toys or imitations or fails to have satisfactory documentation on its safety available, the Icelandic Metrology and Accreditation Service can prohibit its sale.
In case of suspicion that toys or imitations do not meet relevant safety requirements, the surveillance authority can limit their sale and prohibit their distribution temporarily while the matter is being investigated.
If it is established that toys or imitations fail to meet relevant safety requirements the Icelandic Metrology and Accreditation Secvice can prohibit their distribution.
In case toys or imitations are considered extremely dangerous the Icelandic Metrology and Accreditation Service can require an immediate withdrawal of all the product units. The party responsible shall modify the product in order to ensure its conformity with the rules in force, deliver to the purchasers an identical but safe pcoduct or repay the value of the products to the purchasers. However, the Icelandic Metrology and Accreditation Service can decide that any modification or re-use of a product in another way is prohibited if it considers it dangerous or risky. The party responsible can be required to destroy all the product units in a safe way if it is considered necessary under the circumstances.

Article 15

The Icelandic Metrology and Accreditation Service shall, insofar as possible, cooperate with the party responsible on procedures, for example concerning the acquisition of documents, inspection and testing of a product and on measures such as the termination of a sale of a product and withdrawal from the market.
The Icelandic Metrology and Accreditation Service shall, as soon as possible, notify its justified decision to the party responsible along with information on appeal procedures and time limits. The decision shall be supported by the necessary data which, according to circumstances, can be an inspection report, a test report or other relevant data.
The party responsible shall, within normal time limits, have an opportunity to express his views but a derogation from this clause is permitted if a product is considered extremely dangerous.
If the Icelandic Metrology and Accreditation Service has prohibited the sale of a product on the grounds that the product does not fulfill safety requirements the party responsible is authorized to require that the pcoduct is tested by a accredited testing laboratory. Such a test does not postpone the implementation of the Icelandic Metrology and Accreditation Service's decision. .
The Icelandic Metrology and Accreditation Service is authorized to review its decision in case circumstances change.
The decision of the Icelandic Metrology and Accreditation Service may be appealed to the Minister of Commerce but such an appeal shall not postpone the implementation of the decision.

Article 16

The party responsible shall pay any expenses arising in connection with the product samples taken for examination. After the examination the samples shall be returned or destroyed in a safe way, as appropriate.
The party responsible shall pay any expenses arising in connection with withdrawal of products. If the product fails to conform to the rules in force, the party responsible pays the expenses arising from inspection, examination, testing as well as other costs.

CHAPTER VII
Application
Article 17

This Regulation is adopted in accordance with provisions in Act No.100/1992 on Weighing, Measurements and Accreditation, cf. Act No. 102/1994 on Amendments thereof.
This Regulation is adopted in accordance with the following provisions in the EEA Agreement:
l. Council Decision 93/465/EEC concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which ace intended to be used in the technical harmonization directives, cf. item 3 d in Chapter XIX of Annex II. This Decision is published in Book 3 of a special publication of the EEA Supplement to the Official Journal of the European Communities, cf. Act No. 91/1994 on Amendments to the Act on the European Economic Area No. 2/1993, cf. Act No. 66/1993.
2. Directive 88/378/EEC on the approximation of the laws of the member states concerning the safety of toys, cf. point l, Chapter XXIII Annex II, as amended by Directive 93/68/EEC. The former Directive is published in the 25th edition of the special publication EEA-Acts, cf. the Announcement in the C series of the Official Journal No. 31/1993. The latter is published in Book 3 a special publication of the EEA Supplement to the Official Journal of the European Communities, cf. Act No. 91/1994 3.
3. Directive 87/357/EEC on the approximation of the laws of the member states concerning products which, appearing to be other than they are, endanger the health or safety of consumers, cf. point 5, Annex XIX. This Directive is published in 46th edition of the special publication EEA-Acts, cf. the Announcement in the C series of the Official Journal No. 31/1993.

This Regulation shall enter into force immediately.

Ministry of Commerce,12 July 1994.

(Sighvatur Björgvinsson)

(Þorkell Helgason)

 

ANNEX I


Products not regarded as toys for the purpose of this Regulation

1. Christmas decoration.
2. Detailed scale models for adult collectors.
3. Equipment to be used collectively in playgrounds.
4. Sports equipment.
5. Aquatic equipment intended to be used in deep water.
6. Folk dolls and decorative dolls and other similar articles for adult collectors.
7. Professional toys installed in public places (shopping centres, stations, etc.).
8. Puzzles with more than 500 pieces or without picture, intended for specialists.
9. Air guns and air pistols.
10. Fireworks, including percussion caps, excluding percussion caps specially designed for toys.
11. Slings and catapults.
12. Sets of darts with metallic points.
13. Electronic ovens, irons or other functional products operated at nominal voltage exceeding 24 volts.
14. Products containing heating elements intended for use under the supervision of adults in teaching context.
15. Vehicles with combustion engines.
16. Toy steam engines.
17. Bicycles designed for sport or for travel on the public highway, i.e. bicycles where the hight of the saddle exceeds 635 mm.
18. Video toys that can be connected to a video screen, operated at a nominal voltage exceeding 24 volts.
19. Babies' dummies.
20. Faithful reproductions of real fire arms.
21. Fashion jewellry for children.

ANNEX II

 

Essential safety requirements for toys


I. General principles

l. In compliance with the provisions of Article 3 of this Regulation the users of toys as well as third parties must be protected against health hazards and risk of physical injury when toys are used as intended or in a foreseeable way, bearing in mind the normal behaviour of children. Such risks are:

(a) which are connected with the design, construction or composition of the toy,
(b) which are inherent in the use of the toy and cannot be completely eliminated by modifying the toy's construction and composition without altering its function or depriving it of its essential properties.

2. The degree of risk present in the use of a toy must be commensurate with the ability of the users, and where appropriate their supervisors, to cope with it. This applies in particular to toys which, by virtue of their functions, dimensions and characteristics, are intended for use by children of under 3 years.

To observe this principle, a minimum age for users of toys and the need to ensure that they are used only under adult supervision must be specified where appropriate.

3. Labels on toys and their packaging and the instructions for use which accompany them must draw the attention of users or their supervisors fully and effectively to the risks involved in using them and to the ways of avoiding such risks.


II. Particular risks


1. Physical and mechanical properties

(a) 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.
(b) Accessible edges, protrusions, cords, cables and fastenings on toys must be so designed and constructed that the risks of physical injury from contact with them are reduced as far as possible.
(c) Toys must be so designed and constructed as to minimize the risk of physical injury which could be caused by the movement of their parts.
(d) Toys, and their component patts, and any detachable parts of toys which are clearly intended for use of toys which are clearly intended for use by children under 3 years must be of such dimensions as to prevent their being swallowed and inhaled.
(e) Toys, and their parts and the packaging in which they are contained for retail sale must not present risk of strangulation or suffication.
(f) Toys intended for use in shallow water which are capable of carrying or supporting a child on the water must be designed and constructed 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.
(g) 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 latter can open easily from the inside.
(h) 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 developed 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.
(i) The form and composition of projectiles and the kinetic energy they may develop when fired from a toy designed for that purpose must be such that, taking into account the nature of the toy, there is no unreasonable risk of physical injury to the user or to third parties.
(j) Toys containing heating elements must be so constructed as to ensure that:
(i) the maximum temperature of any accessible surfaces does not cause burns when touched,
(ii) liquids and gases contained within toys do not reach temperatures or pressures which are such that their escape from a toy, other than for reasons essential to the proper functioning of the toy, might cause burns, scalds or other physical injury.

2. Flammability

(a) Toys must not constitute a dangerous flammable element in the child's environment. They must therefore be composed of materials which:
(i.) do not burn if directly exposed to a f1ame or spark or other potential seat of fire,
(ii.) are not readily flammable (the f1ame goes out as soon as the fire cause disappears),
(iii.) if they do ignite,burn slowly and present a low cate of spread of the flame
(iv.) irrespective of the toy's chemical composition, are treated so as to delay the combustion process.

Such combustible materials must not constitute a risk of ignition for other materials used in the toy.

(b) Toys which, for reasons essential to their functioning, contain dangerous substances as defined in special regulations, 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 preparations which may become flammable due to the loss of non-flammable volatile components.
(c) Toys must not be explosive or contain elements or substances likely to explode when used as intended according to the provisions of this Regulation. This provision does not apply to toy percussion caps, for which reference should be made to in point 10 of Annex I.
(d) Toys and, in particular, chemical games and toys, must not contain as such substances which may explode:
(i.) when mixed, through chemical reaction, or through heating,
(ii.) when mixed with oxidizing substances which contain volatile components which are flammable in air and liable to form flammable or explosive vapour and air mixture.

3. Chemical properties

(a) Toys must be so designed and constructed that, when used, 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 legislation relating to certain categories of products or to the prohibition, restriction of use or labelling of certain dangerous substances.
(b) For the protection of children's health, bioavailability resulting from the use of toys must not, as an objective, exceed the following levels per day:
0,2 æg for antimony,
0,1 æg for arsenic,
25,0 æg for barium,
0,6 æg for cadmium,
0,3 æg for chromium,
0,7 æg for lead,
0,5 æg for mercury,
5,0 æg for selenium,

or such other values as may be laid down for these or other substances in other law, regulation and administrative action.

The bioavailability of these substances means the soluble extract having toxicological significance.

(c) Toys must not contain toxic or dangerous substances within the meaning of law, regulation and administrative action in amounts which may harm the health of children using them. At all events it is strictly forbidden to include, in a toy, toxic or dangerous substances if they are intended to be used as such while the toy is being used.

However, where a limited number of dangerous substances 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 to be defined for each substance by mandate to the European Committee for Standardization (CEN) according to the procedure of the committee, provided the permitted substances comply with law, regulation and administrative action.

4. Electrical properties

(a) Electric toys must not be powered by electricity of a nominal voltage exceeding 24 volts and no part of the toy may exceed 24volts.
(b) 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.
(c) Electric toys must be so designed and constructed as to ensure that the maximum temperatures reached by all directly accessible surfaces are not such as to cause burns when touched.

5. Hygiene

Toys must be so designed and manufactured as to meet the requirements laid down in law, regulation and administrative action on health, hygiene and cleanliness in order to avoid any risk of infection, sickness and contamination.

6. Radioactivity

Toys must not contain radioactive elements or substances in forms or proportions likely to be detrimental to a child's health. During the manufacture of toys law, regulation and administrative action on radioactivity shall be complied to.

ANNEX III

Harmonized European Standards for Toys

 

The following standards apply to the manufacture of toys:
ÍST EN71-1. Toys. Safety requirement, part 1: Mechanical and physical properties.
ÍST EN71-2. Toys. Safety requirement, part 2: Flammability properties.
ÍST EN71-3. Toys. Safety requirement, part 3: The migration of certain elements.
ÍST EN71-4. Toys. Safety requirement, part 4: Experimental sets for chemistry and related activities.
ÍST EN71-5. Toys. Safety requirement, part 5: Chemical toys other than experimental sets.

CENELEC, HD 271 S1, Regulation on high voltage, C series, Chapter 134 222, part 2. Particular requirements for electric toys supplied at extra low voltage.

Amendment 1: HD 271 S 1,
Amendment 2: HD 271 S1 and
Amendment 3: HD 271 Sl.

ANNEX IV

The Preparation of Declarations of Conformity and Type-approvals

 

1. General aspects

The producer of toys shall apply the relevant modules as described in Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment proceduces and the rules foc the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonization directives.

The party responsible shall lodge a written application for a type-examination to a notified body in the field of toys accompanied by the following:
(a) The name and address of the manufacturer and/or party responsible.
(b) A declaration that the same applicant has not lodged an application with any other notified bodies within the European Economic Area.
(c) The technical documentation shall contain so far as relevant for assessment:
(i.) A general description of the product type.
(ii.) A conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.
(iii.) Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product.
(iv.) A list of the standards applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Regulation where standards have not been applied.
(v.) Results of design calculations made, examinations carried out, etc.
(vi.) If relevant, test reports.

2. The type-approval of toys

The applicant sends to the notified body, according to an agreement, one or more specimens representative of the product envisaged, i.e. so called type or types.

The notified body:

(a) must examine the technical documentation and verify that the type has been manufactured in conformity with them and identify the elements which have been designed in accordance with the relevant standards and which of them not,
(b) must perform or have performed the appropriate examinations and necessary tests to check whether, where the standards have not been applied,the solutions adopted by the manufacturer meet the essential requirements of the Regulation,
(c) must perform or have performed the appropriate examinations and necessary tests to check whether,where the manufacturer has chosen to apply the relevant standards,these have actually been applied,
(d) must agree with the applicant whether the examinations and necessary tests will be carried out,
(e) can decide to have another testing laboratory perform the testing.In that case a consent for that shall be acquired from the applicant.
(f) must issue a CE type - approval certificate.

ANNEX V

A Declaration of Conformity of the Party Responsible for Toys Manufactured in
accordance with Harmonized European Standards

 

The party responsible must affix the CE marking to each product to ensure that the product complies with the requirements of Article 4, paragraph 1 of the Regulation and will thus ensure conformity with the harmonized requirements for toys within the European Economic Area.

To certify this the party responsible shall hold a technical document which enables the design, manufacture and operation of the product to be understood and to assess conformity with the Regulation and thus to assess conformity with the harmonized requirements for toys within the Eucopean Economic Area.

The documentation to be presented at the request of the monitoring party shall contain:

l. The name and address of the party responsible.

2. General description of the product.

3. Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.

4. Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product.

5. A list of the standards applied.

6. A description on how to ensure the conformity of the product to the standards, including the results of design calculations made, examinations carried out, etc.

7. Test reports if relevant.

ANNEX VI

A Declaration of Conformity of the Party Responsible for Type-approved Toys

 

The party responsible must affix the CE marking to each pcoduct to ensure that the product complies with the type described in the type-approval certificate and will thus comply with the requirements of Article 4, paragraph 2 of the Regulation.

If the Icelandic Metrology and Accreditation Secvice or accredited inspection body requests so the following information and documentation shall be submitted:

l. The address of the party responsible.
2. A type-approval certificate and the relevant part of the technical documentation.
3. A copy of the documents submitted to the notified body.
4. A description on how to ensure the conformity of the product to the standards, including the results of design calculations made, examinations carried out, etc.

ANNEX VII

Requirements to be fulfilled by the Notified Body

 

The notified bodies in the field of toys shall fulfill the following requirements in addition to the requirements laid down in Article 4 of the Regulation:

l. They must have available the necessary equipment, funds and employees.

2. Employees shall possess necessary technical knowledge and carry out their profession with utmost honesty.

3. Manager and technicians, who are in charge of tests, report making, issuance of certificates and monitoring operations according to the Regulation must be independent of all interest groups and parties who are involved with toys directly or indirectly.

4. Employees are sworn to professional secrecy.

5. An agreement on liability insurance must be signed except if the state or another public body is liable for damage on behalf of the notified body, according to law.