S.L. 427.40 Art. 3Definitions. Cap. 427. S.L. 427.45 S.L. 419.06 S.L. 419.03 S.L. 419.07 S.L. 419.03

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, that performs conformity assessment activities, including calibration, testing, certification and inspection;

"cosmetic kit" means a toy the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners; "design speed" means representative potential operating speed that is determined by the design of the toy; "distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market;

"economic operators" means the manufacturer, the authorised representative, the importer and the distributor;

"functional product" means a product which performs and is used in the same way as a product, appliance or installation intended for use by adults and which may be a scale model of such product, appliance or installation; "functional toy" means a toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation; "gustative game" means a toy the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas; "harm" means physical injury or any other damage to health, including long-term health effects; "harmonised standard" means a standard adopted by the Malta Standards Authority or one of the European Standardisation bodies listed in Schedule I to the Notification Procedure Regulations, on the basis of a request made by the Commission in accordance with Article 6 of Directive 98/34/EC; "hazard" means a potential source of harm; "importer" means any natural or legal person established in Malta or within the Community who places a toy from a third country on the local or Community market; "intended for use by" means that a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group; "making available on the market" means any supply of a toy for distribution, consumption or use on the local or Community market in the course of a commercial activity, whether in return for payment or free of charge; "manufacturer" means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark; "Market Surveillance Directorate" means the Market Surveillance Directorate of the Malta Standards Authority as described in the Malta Standards Authority (Establishment of

Directorates) Order; "market surveillance" means the activities carried out and measures taken by the Market Surveillance Directorate to ensure that toys comply with the applicable requirements set out in Community harmonisation legislation and do not endanger health or any other aspect of public interest protection; "National Accreditation Board (Malta)" means the National Accreditation Board (Malta) established in terms of regulation 3 of the National Accreditation Board (Malta) (Establishment) Regulations;

"olfactory board game" means a toy the purpose of which is to assist a child to learn to recognise different odours or flavours;

"placing on the market" means the first making available of a toy on the local or Community market;

"recall" means any measure aimed at achieving the return of a toy that has already been made available to the end user; "Regulatory Affairs Directorate" means the Regulatory Affairs Directorate of the Malta Standards Authority as described in the Malta Standards Authority (Establishment of Directorates) Order; "risk" means the probable rate of occurrence of a hazard causing harm and the degree of severity of the harm; "withdrawal" means any measure aimed at preventing a toy in the supply chain from being made available on the market;