Energy-Using Products (Amendment) (No.2) Regulations, 2010

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,645, 14 ta’ Settembru, 2010

Taqsima B

L.N. 433 of 2010

PRODUCT SAFETY ACT

(CAP. 427)

Framework for the Setting of Ecodesign Requirements for

Energy-Using Products (Amendment) (No.2) Regulations, 2010

IN exercise of the powers conferred by articles 38 to 40 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 Framework for

the Setting of Ecodesign Requirements for Energy-Using Products

(Amendment) (No.2) Regulations, 2010 and they shall be read and

construed as one with Framework for the Setting of Ecodesign

Requirements for Energy-Using Products Regulations, 2007

hereinafter referred to as “the principal regulations”.

(2) These regulations implement the requirements

of Directive 2009/125/EC of the European Parliament and of the

Council of 21 October 2009 establishing a framework for the

setting of eco design requirements for energy related products.

Regulation 1 of the principle regulations shall be

amended as

a) for sub-regulation (1) thereof, for the words

“Energy-Using” in the title to the principle regulations, there

shall be substituted the words “Energy-Related”;

b) for sub-regulation (2) thereof , there shall be

substituted the following

“(2) These regulations implements to the

requirements of Directive 2009/125/EC of the European

Parliament and of the Council of 21 October 2009

establishing a framework for the setting of eco design

requirements for energy related products, hereinafter

referred to as “the Directive.””;

c) sub-regulation (7) thereof shall be deleted; and

d) immediately after sub-regulation (5) thereof, shall

be added the following

“(6) The Directorate shall be the competent

authority as regards Articles 3(4), 7(7) and 13(3) of the

Directive.”.

In sub-regulation (1) of regulation 2 of the principal

regulations, for the words “energy using products” shall there be

substituted with the words “energy related products”.

Regulation 3 of the principal regulations shall be

amended as follows

a) For the definition “energy using product” there shall

be substituted the following

“ “energy-related product’, herein after referred

to as a ”product”, means any good that has an impact

on energy consumption during use which is placed on

the market and, or put into service, and includes parts

intended to be incorporated into energy-related products

covered by this Directive which are placed on the market

and, or put into service as individual parts for end-users

and of which the environmental performance can be

assessed independently;”;

b) for the definition “manufacturer” there shall be

substituted the following

“ “manufacturer” means the natural or legal

person who manufactures 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 m nufacturer’s own

name or t rademark or for the manufacturer’s own use.

In the absence of a manufacturer as defined herein or of

an importer as defined in this regulation, any natural or

legal person who places on the market and, or puts into

service products covered by these regulations shall be

considered a manufacturer;” and

c) for the definition of “recovery” there shall be

substituted by the following

“ “recovery” means any of the applicable

operations provided for in Annex II B to Directive

2006/12/EC of the European Parliament and of the

Council of 5 April 2006 on waste 1 ;

In regulations 3, 4, 5, 6, 7, 8, and 10 and in Schedule II

of the principal regulations , for the words “energy using product”

there shall be substituted the word “product” and for the words

“energy using products” there shall be substituted the word

“products” wherever they occur.

Sub-regulation (5) of regulation 4 shall be substituted as

“(5) Where the manufacturer is not established

in the Community and in the absence of an authorised

representative, the importer shall have the following

obligations –

(a) to ensure that the product placed on the

market and, or put into service complies with this

Directive and the applicable implementing measure; and

(b) to keep and make available the EC declaration

of conformity and the technical documentation.”.

In sub-regulations (1) and (3) of regulation 5 of the

principal regulations, for the words “declaration of conformity”

wherever they occur, there shall be substituted the words “EC type

declaration of conformity”.

Sub-regulation (2) of regulation 6 of the principal

regulations shall be substituted as follows

“(2) (a) The conformity assessment procedures shall

be specified by the corresponding implementing measures.

O.J L 396. 30-12-2006, p1

(b) Implementing measures may refer to the following

conformity assessment modules

(i) the internal design control set out in Schedule

IV, and the management system set out in Schedule V;

or

(ii) or a module described in Annex II to Decision

768/2008/EC 2 .

(c) Where the Director of Market Surveillance has

strong indications of probable non-compliance of a product,

he shall immediately inform the Directorate who shall as soon

as possible publish a substantiated assessment of the product’s

compliance which may be conducted by a notified body, in

order to allow, if appropriate, timely corrective action, if any.

(d) Where a 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) 3

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.

(e) If a 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.”.

(3) In sub-regulation 6(4) of the principal regulations

the word “Community” shall be substituted by the words

“institutions of the European Union”

Immediately after regulation 11 of the principal

regulations there shall be added the following new regulation

O.J. No. L 218, 13-08-2008, p 82

O.J. No. L 114, 24-04-2001, p 1

The penalties as provided by the Product Safety

“Penalties 12.

Act shall apply in respect of the infringement of these

regulations.”

Schedule I to the principal regulations shall be

substituted as follows

“ 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 products, focusing on significant

environmental aspects thereof without setting limit values. The

method referred to in this Schedule must be applied when it is

not appropriate to set limit values for the product group under

examination. The Commission must, when preparing a draft

implementing measure to be submitted to the Committee referred to

in Article 19(1) of the Directive, identify significant environmental

aspects which must 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 must identify, as

appropriate to the product 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 must be 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; and

(f) end of life, meaning the state of a product having

reached the end of its first use until its final disposal.

1.2. For each phase, the following environmental aspects

must 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; and

(e) possibilities for reuse, recycling and recovery of

materials and/or of energy, taking into account Directive

2002/96/EC 4 .

1.3. In particular, the following parameters must be used,

as appropriate, and supplemented by others, where necessary, for

evaluating the potential for improving the environmental aspects

referred to in point 1.2

(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 substances 5

and taking into account legislation on the marketing and use

O.J. No. L 218, 13-08-2008, p 82

O.J. No. L 114, 24-04-2001, p 1

of specific substances, such as Council Directives 76/769/

EEC 6 of 27 July 1976 on the approximation of the laws,

regulations and administrative provisions of the Member

States relating to restrictions on the marketing and use of

certain dangerous substances and preparations or Directive

2002/95/EC 7 ;

(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

OJ No. L262, 27-09-1976, p. 201-203.

OJ No. L037, 13-02-2003, p. 19-23.

measures against the emission of gaseous and particulate

pollutants from internal combustion engines to be installed in

non road mobile machinery 8 ;

(l) emissions to water (heavy metals, substances with

an adverse effect on the oxygen balance, persistent organic

pollutants); and

(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).

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

product is handled, used or recycled by parties other than the

manufacturer. This information may include, where applicable

(a) information from the designer relating to the

manufacturing process;

(b) 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;

(c) 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; and

(d) 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 must take into account the obligations under

the other Community legislation, such as Directive 2002/96/EC.

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).

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

products must perform an assessment of the product 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 product’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 must make use of this assessment

to evaluate alternative design solutions and the achieved

environmental performance of the product against benchmarks.

The benchmarks must 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.”.

11. Schedule IV to the principal regulations shall be

substituted as follows

“ 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 product 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 product with the requirements

of the applicable implementing measure will be compiled by the

manufacturer.

The documentation must contain, 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, where 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 those 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; and

(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.”.

Schedule V to the principal regulations shall be

substituted as follows

“ 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 product 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 a product 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 a product, 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

(a) the list of documents that must be prepared to

demonstrate the product’s conformity, and, if relevant, that

have to be made available;

(b) 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;

(c) the checks and tests to be carried out after

manufacture to verify product performance against

environmental performance indicators;

(d) the procedures for controlling the required

documentation and ensuring that it is kept up to date; and

(e) the method of verifying the implementation

and effectiveness of the environmental elements of the

management system.

3.2.

Planning

The manufacturer must 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 options and economic requirements; and

(c) a programme for achieving these objectives.

3.3.

Implementation and documentation

3.3.1. The documentation concerning the management

system must in particular, comply with the following

(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 must be established indicating the

design control and verification techniques implemented and

processes and systematic measures used when designing the

product; and

(c) the manufacturer must 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 must contain, in

particular

(a) a general description of the product 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, where 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 must 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; and

(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.

3.4.

Checking and corrective action

3.4.1 The manufacturer must

(a) take all measures necessary to ensure that the

product is manufactured in compliance with its design

specification and with the requirements of the implementing

measure which applies to it;

(b) establish and maintain procedures to investigate

and respond to non conformity, and implement changes in the

documented procedures resulting from corrective action; and

(c) carry out at least every three years a full

internal audit of the management system with regard to its

environmental elements.”.