Machinery (Amendment) Regulations, 2011

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,733, 12 ta’ April, 2011

L.N. 131 of 2011

PRODUCT SAFETY ACT

(CAP. 427)

Machinery (Amendment) Regulations, 2011

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 Machinery Citation, and scope.

(Amendment) Regulations, 2011 and they shall be read and

construed as one with the Machinery Regulations, 2009 hereinafter L.N. 147 of 2009.

referred to as “the principal regulations”.

(2) These regulations shall come into force on 15th

December, 2011.

(3) These regulations implement the requirements

of Directive 2009/127/EC of the European Parliament and of the

Council of 21 October 2009 amending Directive 2006/42/EC with

regard to machinery for pesticide application.

Immediately after the definition “the Community” in

regulation 3 of the principal regulations, there shall be added the

following new definition

“ “essential health and safety requirements” means

mandatory provisions relating to the design and construction

of the products subject to this Directive to ensure a high level

of protection of the health and safety of persons and, where

appropriate, of domestic animals and property and, where

applicable, of the environment. The essential health and

safety requirements are set out in Schedule I. Essential health

and safety requirements for the protection of the environment

are applicable only to the machinery referred to in section 2.4

of that Schedule;”.

For sub-regulation (1) of regulation 5 of the principal

regulations, there shall be substituted the following

“(1) The Market Surveillance Directorate shall take all

appropriate measures to ensure that machinery may be placed

on the market and, or put into service only if it satisfies the

relevant provisions of this Directive and does not endanger the

health and safety of persons and, where appropriate, domestic

animals and property and, where applicable, the environment,

when such machinery is properly installed and maintained and

used for its intended purpose or under reasonably foreseeable

conditions.”.

For sub-regulation (1) of regulation 10 of the principal

regulations there shall be substituted the following

“(1) Where it is ascertained that machinery covered

by these Regulation, bearing the CE marking, accompanied

by the EC declaration of conformity and used in accordance

with its intended purpose or under reasonably foreseeable

conditions, is liable to endanger the health or safety of persons

or, where appropriate, domestic animals or property or, where

applicable, the environment, it shall take all appropriate

measures to withdraw such machinery from the market, to

prohibit the placing on the market and or putting into service

of such machinery or to restrict the free movement thereof.”.

Schedule I to the principal regulations shall be amended

as follows

(a) in the General Principles, point 4 thereof shall be

substituted as follows

“4. This Schedule is organised in several parts.

The first one is of general scope and applicable to all

kinds of machinery. The other parts refer to certain kinds

of more specific hazards. Nevertheless, it is essential to

examine the whole of this Schedule in order to be sure

of meeting all the relevant essential requirements. When

machinery is being designed, the requirements of the

general part and the requirements of one or more of the

other parts shall be taken into account, depending on the

results of the risk assessment carried out in accordance

with point 1 of these General Principles. Essential

health and safety requirements for the protection of

the environment are applicable only to the machinery

referred to in section 2.4.”; and

(b) section 2 thereof, headed “Supplementary Essential

Health and Safety Requirements for Certain Categories of

Machinery”, shall be amended as follows

(i) for the first paragraph thereof, there shall be

substituted the following

“Foodstuffs machinery, machinery for

cosmetics or pharmaceutical products, hand-

held and/or hand-guided machinery, portable

fixing and other impact machinery, machinery for

working wood and material with similar physical

characteristics and machinery for pesticide

application must meet all the essential health and

safety requirements set out in this chapter (see

General Principles, point 4).”; and

(ii) immediately after section 2.3 there shall be

added the following new section

“2.4. MACHINERY FOR PESTICIDE

APPLICATION

Definition

2.4.1.

“Machinery for pesticide application” means

machinery specifically intended for the application

of plant protection products within the meaning

of Article 2(1) of Regulation (EC) No 1107/2009

of the European Parliament and of the Council of

21 October 2009 concerning the placing of plant

protection products on the market (*).

General

2.4.2.

The manufacturer of machinery for pesticide

application or his authorised representative must

ensure that an assessment is carried out of the risks

of unintended exposure of the environment to

pesticides, in accordance with the process of risk

assessment and risk reduction referred to in the

General Principles, point 1.

B

Machinery for pesticide application must be

designed and constructed taking into account the

results of the risk assessment referred to in the first

paragraph so that the machinery can be operated,

adjusted and maintained without unintended

exposure of the environment to pesticides.

Leakage must be prevented at all times.

Controls and monitoring

2.4.3.

It must be possible to easily and accurately

control, monitor and immediately stop the pesticide

application from the operating positions.

Filling and emptying

2.4.4.

The machinery must be designed and

constructed to facilitate precise filling with the

necessary quantity of pesticide and to ensure easy

and complete emptying, while preventing spillage

of pesticide and avoiding the contamination of the

water source during such operations.

Application of pesticides

2.4.5.

Application rate

2.4.5.1.

The machinery must be fitted with means of

adjusting the application rate easily, accurately and

reliably.

Distribution, deposition and drift

2.4.5.2.

of pesticide

The machinery must be designed and

constructed to ensure that pesticide is deposited on

target areas, to minimise losses to other areas and

to prevent drift of pesticide to the environment.

Where appropriate, an even distribution and

homogeneous deposition must be ensured.

Tests

2.4.5.3.

In order to verify that the relevant parts of the

B

machinery comply with the requirements set out

in sections 2.4.5.1 and 2.4.5.2 the manufacturer or

his authorised representative must, for each type of

machinery concerned, perform appropriate tests, or

have such tests performed.

Losses during stoppage

2.4.5.4.

The machinery must be designed and

constructed to prevent losses while the pesticide

application function is stopped.

Maintenance

2.4.6.

Cleaning

2.4.6.1.

The machinery must be designed and

constructed to allow its easy and thorough cleaning

without contamination of the environment.

Servicing

2.4.6.2.

The machinery must be designed and

constructed to facilitate the changing of worn parts

without contamination of the environment.

Inspections

2.4.7.

It must be possible to easily connect the

necessary measuring instruments to the machinery

to check the correct functioning of the machinery.

Marking of nozzles, strainers and

2.4.8.

filters

Nozzles, strainers and filters must be marked

so that their type and size can be clearly identified.

Indication of pesticide in use

2.4.9.

Where appropriate, the machinery must

be fitted with a specific mounting on which the

operator can place the name of the pesticide in use.

B

Instructions

2.4.10.

The instructions must provide the following

information

(a) precautions to be taken during

mixing, loading, application, emptying,

cleaning, servicing and transport operations

in order to avoid contamination of the

environment;

(b) detailed conditions of use for the

different operating environments envisaged,

including the corresponding preparation and

adjustments required to ensure the deposition

of pesticide on target areas while minimising

losses to other areas, to prevent drift to the

environment and, where appropriate, to

ensure an even distribution and homogeneous

deposition of pesticide;

(c) the range of types and sizes of

nozzles, strainers and filters that can be used

with the machinery;

(d) the frequency of checks and the

criteria and method for the replacement of

parts subject to wear that affect the correct

functioning of the machinery, such as nozzles,

strainers and filters;

(e) specification of calibration, daily

maintenance, winter preparation and other

checks necessary to ensure the correct

functioning of the machinery;

(f) types of pesticides that may cause

incorrect functioning of the machinery;

(g) an indication that the operator

should keep updated the name of the pesticide

in use on the specific mounting referred to in

section 2.4.9;

(h)

the connexion and use of any

B

special equipment or accessories, and the

necessary precautions to be taken;

(i) an indication that the machinery

may be subject to national requirements for

regular inspection by designated bodies, as

provided for in Directive 2009/128/EC of the

European Parliament and of the Council of 21

October 2009 establishing a framework for

Community action to achieve the sustainable

use of pesticides (**);

(j) the features of the machinery

which must be inspected to ensure its correct

functioning;

(k) instructions for connecting the

necessary measuring instruments.”

(*) OJ L 309, 24.11.2009, p. 1.

(**) OJ L 309, 24.11.2009, p. 71.’