Framework for the Setting of Ecodesign Requirements for Energy-Using Products Regulations, 2007 (L.N. 347 of 2007)

1. (1) The title of these regulations is Framework for the Setting Citation and commencement. of Ecodesign Requirements for Energy-Using Products Regulations, 2007. (2) These regulations implement the requirements of Directive 2005#32#EC1 of the European Parliament and of the Council of 6th July 2005 Establishing a Framework for the Setting of Ecodesign Requirements for Energy-Using Products and Amending Council Directive 92#42#EEC2 and Directives 96#57#EC3 and 2000#55#EC4 of the European Parliament and of the Council, hereinafter referred to as “the Directive”. (3) These regulations shall be read and construed with each of the regulations listed in regulation 2(2) of these regulations but separately from the other regulations in the said list. (4) These regulations shall come into force on the 11th August, 2007. (5) These regulations and the implementing measures shall be without prejudice to Community waste management legislation and Community chemicals legislation, including Community legislation on fluorinated greenhouse gases. ______________________________ 1 OJ No. L 191, 22-07-2005, p. 1 2 OJ No. L 167, 22-06-1992, p. 17-28. 3 OJ No. L 236, 18-09-1996, p. 36-43. 4 OJ No L 279, 01-11-2000, p. 33-39. B 4278 (6) A product which does not comply with these regulations shall be deemed an unsafe product within the meaning of the Product Cap. 427. Safety Act. (7) The Directorate shall be the competent authority as regards Articles 3(4), 7(7) and 13(2) of the Directive. Scope and 2. (1) These regulations provide for the setting of requirements application. which energy using products covered by implementing measures must fulfil in order for them to be placed on the market or put into service. They contribute to sustainable development by increasing energy efficiency and the level of protection of the environment, while at the same time increasing the security of the energy supply. (2) These regulations shall apply to the following energy using products> – Hot water boilers within the meaning of the Efficiency Requirements for New Hot-Water Boilers Fired with Liquid or Gaseous Fuels (Implementing Measures) Regulations, 2007. – Household refrigerators within the meaning of the Energy Efficiency Requirements for Household Electric Refrigerators, Freezers and Combinations thereof (Implementing Measures) Regulations, 2007. – Ballast for fluorescent lighting within the meaning of the Efficiency Requirements for Ballasts for Fluorescent Lighting (Implementing Measures) Regulations, 2007. (3) These regulations shall not apply to means of transport for persons and goods. Definitions. 3. For the purposes of these regulations, the following definitions shall apply> “authorised representative” means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with these regulations or the Directive< “the Community” means the European Community< “components and sub assemblies” means parts intended to be incorporated into energy-using products, and which are not placed on the market and#or put into service as individual parts for B 4279 end users or the environmental performance of which cannot be assessed independently< “the Directorate” means the Consumer and Industrial Goods Directorate of the Malta Standards Authority, as established by L.N. 213 of 2000. virtue of the Malta Standards Authority (Establishment of Directorates) Order, 2000 – published in the Government Gazette No. 17,002 of 20th October, 2000< “ecodesign” means the integration of environmental aspects into product design with the aim of improving the environmental performance of the energy-using product throughout its whole life cycle< “ecodesign requirement” means any requirement in relation to an energy-using product, or the design of an energy-using product, intended to improve its environmental performance, or any requirement for the supply of information with regard to the environmental aspects of an energy-using product< “ecological profile” means a description, in accordance with the implementing measure applicable to the energy-using product, of the inputs and outputs (such as materials, emissions and waste) associated with an energy-using product throughout its life cycle which are significant from the point of view of its environmental impact and are expressed in physical quantities that can be measured< “energy recovery” means the use of combustible waste as a means to generate energy through direct incineration with or without other waste but with recovery of the heat< “energy-using product” means a product which, once placed on the market and#or put into service, is dependent on energy input (electricity, fossil fuels and renewable energy sources) to work as intended, or a product for the generation, transfer and measurement of such energy, including parts dependent on energy input and intended to be incorporated into an energy-using product covered by these regulations which are placed on the market or put into service as individual parts for end users and of which the environmental performance can be assessed independently. For the purpose of these regulations “energy-using product” shall have the meaning given in regulation 2(2) of these regulations< B 4280 “environmental aspect” means an element or function of an energy-using product that can interact with the environment during its life cycle< “environmental impact” means any change to the environment wholly or partially resulting from an energy-using product during its life cycle< “environmental performance” of an energy-using product means the results of the manufacturer’s management of the environmental aspects of the energy-using product, as reflected in its technical documentation file< “generic ecodesign requirement” means any ecodesign requirement based on the ecological profile as a whole of an energy- using product without set limit values for particular environmental aspects< “harmonised standard” means a technical specification adopted by a recognised standards body under a mandate from the Commission, in accordance with the procedure laid down in Directive 98#34#EC of the European Parliament and of the Council of 22nd June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations5, for the purpose of establishing a European requirement, compliance with which is not compulsory< “hazardous waste” means any waste which is covered by Article 1(4) of Council Directive 91#689#EEC of 12th December 1991 on hazardous waste6< “implementing measures” are measures adopted pursuant to the Directive laying down eco-design requirements for defined energy-using products or for environmental aspects thereof.. For the purpose of these regulations “implementing measures” are listed in regulation 2(2) hereto< “importer” means any natural or legal person established in the Community who places a product from a third country on the Community market in the course of his business< “improvement of the environmental performance” means the process of enhancing the environmental performance of an energy- using product over successive generations, although not necessarily in respect of all environmental aspects of the product simultaneously< _____________________________ 5 OJ No. L 204, 21-07-1998, p. 37. As last amended by the 2003 Act of Accession. 6 OJ No. L 377, 31-12-1991, p. 20. Directive as amended by Directive 94#31#EC (OJ No. L 168, 02-07-1994, p. 28). B 4281 “life cycle” means the consecutive and interlinked stages of an energy-using product from raw material use to final disposal< “manufacturer” means the natural or legal person who manufactures energy-using products covered by these regulations and is responsible for their conformity with these regulations in view of their being placed on the market or put into service under the manufacturer’s own name or trademark or for the manufacturer’s own use. In the absence of a manufacturer as defined in the first sentence or of an importer as defined below, any natural or legal person who places on the market or puts into service energy-using products covered by these regulations shall be considered a manufacturer< “materials” means all materials used during the life cycle of an energy-using product< “notified body” means a body designated by the competent national administration of a Member State in accordance with these regulations and the respective implementing measure< “OJ” means the Official Journal of the European Communities< “placing on the market” means making an energy-using product available for the first time on the Community market with a view to its distribution or use within the Community whether for reward or free of charge and irrespective of the selling technique< “product design” means the set of processes that transform legal, technical, safety, functional, market or other requirements to be met by an energy-using product into the technical specification for that energy-using product< “putting into service” means the first use of an energy-using product for its intended purpose by an end user in the Community< “recovery” means any of the applicable operations provided for in Annex II B to Council Directive 75#442#EEC of 15th July 1975 on waste7< “recycling” means the reprocessing in a production process of waste materials for the original purpose or for other purposes but excluding energy recovery< _____________________________ 7 OJ No. L 194, 25-07-1975, p. 39. Directive as last amended by Regulation (EC) No. 1882#2003. B 4282 “reuse” means any operation by which an energy-using product or its components, having reached the end of their first use, are used for the same purpose for which they were conceived, including the continued use of an energy-using product which is returned to a collection point, distributor, recycler or manufacturer, as well as reuse of an energy-using product following refurbishment< “specific ecodesign requirement” means a quantified and measurable ecodesign requirement relating to a particular environmental aspect of an energy-using product, such as energy consumption during use, calculated for a given unit of output performance< “waste” means any substance or object in the categories set out in Schedule I to the Waste Management (Permit and Control) L.N. 337 of 2001. Regulations, 2001 which the holder discards or intends or is required to discard. Placing on the 4. (1) Energy-using products may be placed on the market or market and putting into service. put into service only if they comply with the corresponding implementing measures and bear the CE marking in accordance with regulation 5 of these regulations. (2) The placing on the market and#or putting into service of an energy-using product that complies with all the relevant provisions of the applicable implementing measure and bears the CE marking in accordance with regulation 5 of these regulations shall not be prohibited, restricted or impeded, on grounds of eco-design requirements relating to those eco-design parameters referred to Schedule I, Part 1 of these regulations. (3) The placing on the market or putting into service of an Energy-using product bearing the CE marking in accordance with regulation 5 of these regulations shall not be prohibited, restricted or impeded, on grounds of eco-design requirements relating to those eco- design parameters referred to in Schedule I, Part 1 of these regulations, for which the applicable implementing measure provides that no eco- design requirement is necessary. (4) The display of energy-using products which are not in conformity with the provisions of the applicable implementing measure, for example at trade fairs, exhibitions and demonstrations, shall not be prevented, provided that there is a visible indication that they may not be placed on the market or put into service until brought into conformity. B 4283 (5) Where the manufacturer is not established in the Community and in the absence of an authorised representative, the obligation> (a) to ensure that the energy-using product placed on the market or put into service complies with these regulations and the applicable implementing measure and, (b) to keep the declaration of conformity and the technical documentation available, shall lie with the importer.

5. (1) Before an energy-using product covered by implementing Marking and measures is placed on the market or put into service, a CE conformity declaration conformity. of marking shall be affixed and a declaration of conformity issued whereby the manufacturer or its authorised representative ensures and declares that the energy-using product complies with all relevant provisions of the applicable implementing measure. (2) The CE conformity marking consists of the initials “CE” as shown in Schedule II to these regulations. (3) The declaration of conformity shall contain the elements specified in Schedule III to these regulations, and shall refer to the appropriate implementing measure. (4) The affixing of markings on an energy-using product which are likely to mislead users as to the meaning or form of the CE marking shall be prohibited.

6. (1) Before placing an energy-using product covered by Conformity assessment. implementing measures on the market or putting such an energy-using product into service, the manufacturer or its authorised representative shall ensure that an assessment of the energy-using product’s conformity with all the relevant requirements of the applicable implementing measure is carried out. (2) (a) The conformity assessment procedures shall be specified by the corresponding implementing measures. (i) Implementing measures may refer to the following conformity assessment modules> - the internal design control set out in Schedule IV to these regulations, and the management system set out in Schedule V to these regulations< B 4284 - or a module described in Decision 93#465#EEC8 (b) If the Director of Consumer Affairs has strong indications of probable non-compliance of an energy-using product, he shall immediately inform the Directorate who shall as soon as possible publish a substantiated assessment of the energy-using product’s compliance which may be conducted by a notified body, in order to allow timely corrective action, if any. (c) If an energy-using product covered by implementing measures is designed by an organisation registered in accordance with Regulation (EC) No. 761#2001 of the European Parliament and of the Council of 19th March 2001 allowing voluntary participation by organisations in a Community Eco Management and Audit Scheme (EMAS)9 and the design function is included within the scope of that registration, the management system of that organisation shall be presumed to comply with the requirements of Schedule V to these regulations. (d) If an energy-using product covered by implementing measures is designed by an organisation having a management system which includes the product design function and which is implemented in accordance with harmonised standards the reference numbers of which have been published in the OJ, that management system shall be presumed to comply with the corresponding requirements of Schedule V to these regulations. (3) (a) After placing an energy-using product covered by implementing measures on the market or putting it into service, the manufacturer or its authorised representative shall keep relevant documents relating to the conformity assessment performed and declarations of conformity issued available for inspection for a period of 10 years after the last of that energy-using product has been manufactured. (b) The relevant documents shall be made available within 10 days upon receipt of a request by the Director of Consumer Affairs. (4) Documents relating to the conformity assessment and declaration of conformity referred to in regulation 5 of these regulations shall be drawn up in one of the official languages of the Community. ______________________________ 8 OJ No. L 220, 30-08-1993, p. 23. 9 OJ No. L 114, 24-04-2001, p. 1. B 4285

7. (1) An energy-using product bearing the CE marking referred Presumption of conformity and to in regulation 5 of these regulations shall be regarded as conforming Harmonised Standards. to the relevant provisions of the applicable implementing measure. (2) An energy-using product for which harmonised standards have been applied, the reference numbers of which have been published in the OJ, shall be regarded as conforming to all the relevant requirements of the applicable implementing measure to which such standards relate. (3) Energy-using products which have been awarded the Community eco-label pursuant to Regulation (EC) No. 1980#2000 shall be presumed to comply with the ecodesign requirements of the applicable implementing measure insofar as those requirements are met by the eco-label.

8. (1) When required by an implementing measure, Information manufacturers or their authorised representatives who place components requirements. and sub-assemblies on the market or put them into service shall provide the manufacturer of an energy-using product covered by implementing measures with relevant information on the material composition and the consumption of energy, materials or resources of the components or sub-assemblies. (2) In accordance with the applicable implementing measure, manufacturers of energy-using products shall ensure, in the form they deem appropriate, that consumers of energy-using products are provided with> (a) the requisite information on the roles that they can play in the sustainable use of the product and (b) when required by the implementing measures, the ecological profile of the product and the benefits of ecodesign.

9. Where implementing measures require the supply of Confidentiality. information, as referred to in regulation 8(1) of these regulations or Schedule I Part 2 to these regulations, by the manufacturer or its authorised representative, such requirements shall be proportionate and shall take into account the legitimate confidentiality of commercially sensitive information.

10. (1) Where it is ascertained that an energy-using product Withdrawal and prohibition from bearing the CE marking referred to in regulation 5 of these regulations market. and used in accordance with its intended use does not comply with all the relevant provisions of the applicable implementing measure, the B 4286 manufacturer or its authorised representative shall be obliged to make the energy-using product comply with the provisions of the applicable implementing measure or with the CE marking and to end the infringement under conditions imposed by the Director of Consumer Affairs. (2) Where there is sufficient evidence that an energy-using product might be non-compliant, the Director of Consumer Affairs shall take the necessary measures which, depending on the gravity of the non-compliance, can go as far as the prohibition of the placing on the market of the energy-using product until compliance is established. (3) Where non-compliance continues, the Director of Consumer Affairs shall take a decision restricting or prohibiting the placing on the market or putting into service of the energy-using product in question or ensure that it is withdrawn from the market. (4) (a) Any decision by the Director of Consumer Affairs pursuant to these regulations which restricts or prohibits the placing on the market or putting into service of an energy-using product shall state the exact grounds on which it is based and the Director of Consumer Affairs shall so inform the Directorate thereof. (b) The Director of Consumer Affairs shall forthwith notify the decision to the party concerned, who shall at the same time be informed of the legal remedies available under the laws in force in Malta concerned and of the time limits to which such remedies are subject. (5) The Director of Consumer Affairs shall immediately inform the Directorate of any decision taken pursuant to regulation 10(1) of these regulations, and in particular, whether non-compliance is due to> (a) failure to satisfy the requirements of the applicable implementing measure< (b) incorrect application of harmonised standards< (c) shortcomings in the harmonised standards. (6) The Directorate shall immediately inform the Commission of any measures taken in pursuance of sub-regulations 10(1) to 10(5) of these regulations. B 4287

11. The Method for Designating Conformity Assessment Bodies Notified Bodies. Regulations, 2003, as applied to these regulations and the corresponding L.N. 136 of 2003. implementing measure, shall set out the conditions for the recognition of competence and the subsequent approval of notified bodies. B 4288 Schedule I Based on Annex I of the Directive METHOD FOR SETTING GENERIC ECODESIGN REQUIREMENTS (Referred to in regulations 4 and 9 to these regulations) Generic ecodesign requirements aim at improving the environmental performance of s, focusing on significant environmental aspects thereof without setting limit values. The method according to this Schedule will be applied when it is not appropriate to set limit values for the product group under examination. The Commission shall, when preparing a draft implementing measure to be submitted to the Committee referred to in Article 19 of the Directive, identify significant environmental aspects which shall be specified in the implementing measure. In preparing implementing measures laying down generic ecodesign requirements pursuant to Article 15 of the Directive and Schedule I to these regulations, the Commission will identify, as appropriate to the covered by the implementing measure, the relevant ecodesign parameters from among those listed in Part 1, the information supply requirements from among those listed in Part 2 and the requirements for the manufacturer listed in Part 3. Part 1. Ecodesign parameters for energy-using products 1.1. In so far as they relate to product design, significant environmental aspects are identified with reference to the following phases of the lifecycle of the product: (a) raw material selection and use; (b) manufacturing; (c) packaging, transport, and distribution; (d) installation and maintenance; (e) use; (f) end-of-life, meaning the state of an having reached the end of its first use until its final disposal. 1.2. For each phase, the following environmental aspects are to be assessed where relevant: (a) predicted consumption of materials, of energy and of other resources such as fresh water; (b) anticipated emissions to air, water or soil; (c) anticipated pollution through physical effects such as noise, vibration, radiation, electromagnetic fields; (d) expected generation of waste material; (e) possibilities for reuse, recycling and recovery of materials and/or of energy, taking into account 10/18 B 4289 Directive 2002/96/EC10. 1.3. In particular, the following parameters will be used, as appropriate, and supplemented by others, where necessary, for evaluating the potential for improving the environmental aspects mentioned in the previous paragraph: (a) weight and volume of the product; (b) use of materials issued from recycling activities; (c) consumption of energy, water and other resources throughout the life cycle; (d) use of substances classified as hazardous to health and/or the environment according to Council Directive 67/548/EEC of 27th June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packing and labelling of dangerous substances11 and taking into account legislation on the marketing and use of specific substances, such as Directives 76/769/EEC12 or 2002/95/EC13; (e) quantity and nature of consumables needed for proper use and maintenance; (f) ease for reuse and recycling as expressed through: number of materials and components used, use of standard components, time necessary for disassembly, complexity of tools necessary for disassembly, use of component and material coding standards for the identification of components and materials suitable for reuse and recycling (including marking of plastic parts in accordance with ISO standards), use of easily recyclable materials, easy access to valuable and other recyclable components and materials; easy access to components and materials containing hazardous substances; (g) incorporation of used components; (h) avoidance of technical solutions detrimental to reuse and recycling of components and whole appliances; (i) extension of lifetime as expressed through: minimum guaranteed lifetime, minimum time for availability of spare parts, modularity, upgradeability, reparability; (j) amounts of waste generated and amounts of hazardous waste generated; (k) emissions to air (greenhouse gases, acidifying agents, volatile organic compounds, ozone depleting substances, persistent organic pollutants, heavy metals, fine particulate and suspended particulate matter) without prejudice to Directive 97/68/EC of the European Parliament and of the Council of 16th December 1997 relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery14; (l) emissions to water (heavy metals, substances with an adverse effect on the oxygen balance, persistent organic pollutants); (m) emissions to soil (especially leakage and spills of dangerous substances during the use phase of the product, and the potential for leaching upon its disposal as waste). 10 OJ NO. L037, 13-02-2003, p. 24-39. 11 OJ No. L196, 16-08-1967, p. 1. Directive as last amended by Commission Directive 2004/73/EC (OJ No. L152, 30-04-2004, p. 1). 12 OJ No. L262, 27-09-1976, p. 201-203. 13 OJ No. L037, 13-02-2003, p. 19-23. 14 OJ No. L59, 27-02-1998, p. 1. Directive as last amended by Directive 2004/26/EC (OJ NO. L146, 30-04-2004, p. 1). 11/18 B 4290 Part 2. Requirements relating to the supply of information Implementing measures may require information to be supplied by the manufacturer that may influence the way the is handled, used or recycled by parties other than the manufacturer. This information may include, where applicable: − information from the designer relating to the manufacturing process; − information for consumers on the significant environmental characteristics and performance of a product, accompanying the product when it is placed on the market to allow consumers to compare these aspects of the products; − information for consumers on how to install, use and maintain the product in order to minimise its impact on the environment and to ensure optimal life-expectancy, as well as on how to return the product at end-of-life, and, where appropriate, information on the period of availability of spare parts and the possibilities of upgrading products; − information for treatment facilities concerning disassembly, recycling, or disposal at end-of-life. Information should be given on the product itself wherever possible. This information will take into account obligations under other Community legislation, such as Directive 2002/96/EC. Part 3. Requirements for the manufacturer

1. Addressing the environmental aspects identified in the implementing measure as capable of being influenced in a substantial manner through product design, manufacturers of s will be required to perform an assessment of the model throughout its lifecycle, based upon realistic assumptions about normal conditions and purposes of use. Other environmental aspects may be examined on a voluntary basis. On the basis of this assessment manufacturers will establish the 's ecological profile. It will be based on environmentally relevant product characteristics and inputs/outputs throughout the product life cycle expressed in physical quantities that can be measured.

2. Manufacturers will make use of this assessment to evaluate alternative design solutions and the achieved environmental performance of the product against benchmarks. The benchmarks will be identified by the Commission in the implementing measure on the basis of information gathered during the preparation of the measure. The choice of a specific design solution will achieve a reasonable balance between the various environmental aspects and between environmental aspects and other relevant considerations, such as safety and health, technical requirements for functionality, quality, and performance, and economic aspects, including manufacturing costs and marketability, while complying with all relevant legislation 12/18 B 4291

Schedule II Based on Annex III of the Directive CE MARKING (Referred to in regulation 5 of these regulations) The CE conformity marking shall consist of the initials ‘CE’ taking the following form: The CE marking must have a height of at least 5 mm. If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. The CE marking must be affixed visibly, legibly and indelibly to the energy using product. Where this is not possible, it must be affixed to the packaging and to the accompanying documents. 13/18 B 4292

Schedule III Based on Annex VI of the Directive DECLARATION OF CONFORMITY (Referred to in regulation 5.(3) of these regulations) The EC declaration of conformity must contain the following elements: 1. the name and address of the manufacturer or of its authorised representative; 2. a description of the model sufficient for unambiguous identification; 3. where appropriate, the references of the harmonised standards applied; 4. where appropriate, the other technical standards and specifications used; 5. where appropriate, the reference to other Community legislation providing for the affixing of the CE mark that is applied; 6. identification and signature of the person empowered to bind the manufacturer or its authorised representative. 14/18 B 4293

Schedule IV Based on Annex IV of the Directive INTERNAL DESIGN CONTROL (Referred to in regulation 6 of these regulations) 1. This Schedule describes the procedure whereby the manufacturer or its authorised representative who carries out the obligations laid down in section 2 of this Schedule ensures and declares that the satisfies the relevant requirements of the applicable implementing measure. The declaration of conformity may cover one or more products and must be kept by the manufacturer. 2. A technical documentation file making possible an assessment of the conformity of the with the requirements of the applicable implementing measure will be compiled by the manufacturer. The documentation will specify, in particular: (a) a general description of the and of its intended use; (b) the results of relevant environmental assessment studies carried out by the manufacturer, and/or references to environmental assessment literature or case studies, which are used by the manufacturer in evaluating, documenting and determining product design solutions; (c) the ecological profile, if required by the implementing measure; (d) elements of the product design specification relating to environmental design aspects of the product; (e) a list of the appropriate standards referred to in regulation 7.(2) of these regulations, applied in full or in part, and a description of the solutions adopted to meet the requirements of the applicable implementing measure where the standards referred to in regulation 7.(2) of these regulations have not been applied or where these standards do not cover entirely the requirements of the applicable implementing measure; (f) a copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements specified in Annex I, Part 2 of the Directive, which is set out in Schedule I, Part 2 to these regulations; (g) the results of measurements on the ecodesign requirements carried out, including details of the conformity of these measurements as compared with the ecodesign requirements set out in the applicable implementing measure. 3. The manufacturer must take all measures necessary to ensure that the product will be manufactured in compliance with the design specifications referred to in section 2 and with the requirements of the measure which apply to it. 15/18 B 4294

Schedule V Based on Annex V of the Directive MANAGEMENT SYSTEM FOR ASSESSING CONFORMITY (Referred to in regulation 6 of these regulations) 1. This Schedule describes the procedure whereby the manufacturer who satisfies the obligations of section 2 of this Schedule ensures and declares that the satisfies the requirements of the applicable implementing measure. The declaration of conformity may cover one or more products and must be kept by the manufacturer. 2. A management system may be used for the conformity assessment of an provided that the manufacturer implements the environmental elements specified in section 3 of this Schedule. 3. Environmental elements of the management system This section specifies the elements of a management system and the procedures by which the manufacturer can demonstrate that the complies with the requirements of the applicable implementing measure. 3.1. The environmental product performance policy The manufacturer must be able to demonstrate conformity with the requirements of the applicable implementing measure. The manufacturer must also be able to provide a framework for setting and reviewing environmental product performance objectives and indicators with a view to improving the overall environmental product performance. All the measures adopted by the manufacturer to improve the overall environmental performance of and to establish the ecological profile of an , if required by the implementing measure, through design and manufacturing, must be documented in a systematic and orderly manner in the form of written procedures and instructions. These procedures and instructions must contain, in particular, an adequate description of: – the list of documents that must be prepared to demonstrate the 's conformity, And – if relevant – that have to be made available; – the environmental product performance objectives and indicators and the organisational structure, responsibilities, powers of the management and allocation of resources with regard to their implementation and maintenance; – the checks and tests to be carried out after manufacture to verify product performance against environmental performance indicators; – procedures for controlling the required documentation and ensuring that it is kept up to date; the method of verifying the implementation and effectiveness of the environmental elements of the management system. 16/18 B 4295 3.2. Planning The manufacturer will establish and maintain (a) procedures for establishing the ecological profile of the product; (b) environmental product performance objectives and indicators, which consider technological options taking into account technical and economic requirements; (c) a programme for achieving these objectives. 3.3. Implementation and documentation 3.3.1. The documentation concerning the management system should cover the following, in particular: (a) responsibilities and authorities will be defined and documented in order to ensure effective environmental product performance and reporting on its operation for review and improvement; (b) documents will be established indicating the design control and verification techniques implemented and processes and systematic measures used when designing the product; (c) the manufacturer will establish and maintain information to describe the core environmental elements of the management system and the procedures for controlling all documents required. 3.3.2. The documentation concerning the will specify, in particular: (a) a general description of the and of its intended use; (b) the results of relevant environmental assessment studies carried out by the manufacturer, and/or references to environmental assessment literature or case studies, which are used by the manufacturer in evaluating, documenting and determining product design solutions; (c) the ecological profile, if required by the implementing measure; (d) documents describing the results of measurements on the ecodesign requirements carried out including details of the conformity of these measurements as compared with the ecodesign requirements set out in the applicable implementing measure; (e) the manufacturer will establish specifications indicating, in particular, standards which have been applied; where standards referred to in regulation 8.(5) of these regulations are not applied or where they do not cover entirely the requirements of the relevant implementing measure, the means used to ensure compliance; (f) a copy of the information concerning the environmental design aspects of the product provided in accordance with the requirements specified in Annex I, Part 2 of the Directive, which is set out in

Schedule I, Part 2 to these regulations. 17/18 B 4296 3.4. Checking and corrective action (a) the manufacturer must take all measures necessary to ensure that the is manufactured in compliance with its design specification and with the requirements of the implementing measure which applies to it; (b) the manufacturer will establish and maintain procedures to investigate and respond to non-conformity, and implement changes in the documented procedures resulting from corrective action; (c) the manufacturer will carry out at least every three years a full internal audit of the management system with regard to its environmental elements. _______________________________________________________________________________________________________________________ Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press Prezz#Price Lm0.40 (€0.93) 18/18