---

(k) instructions for the putting into service and use of the machinery and, if necessary, instructions for the training of operators;

(l) information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted;

(m) instructions on the protective measures to be taken by the user, including, where appropriate, the personal protective equipment to be provided;

(n) the essential characteristics of tools which may be fitted to the machinery;

(o) the conditions in which the machinery meets the requirement of stability during use, transportation, assembly, dismantling when out of service, testing or foreseeable breakdowns;

(p) instructions with a view to ensuring that transport, handling and storage operations can be made safely, giving the mass of the machinery and of its various parts where these are regularly to be transported separately;

(q) the operating method to be followed in the event of accident or breakdown; if a blockage is likely to occur, the operating method to be followed so as to enable the equipment to be safely unblocked;

(r) the description of the adjustment and maintenance operations that should be carried out by the user and the preventive maintenance measures that should be observed;

(s) instructions designed to enable adjustment and maintenance to be carried out safely, including the protective measures that should be taken during these operations;

(t) the specifications of the spare parts to be used, when these affect the health and safety of operators;

(u) the following information on airborne noise emissions:

- the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,

- the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 muPa),

- the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

In the case of very large machinery, instead of the A-weighted sound power level, the A-weighted emission sound pressure levels at specified positions around the machinery may be indicated.

Where the harmonised standards are not applied, sound levels must be measured using the most appropriate method for the machinery. Whenever sound emission values are indicated the uncertainties surrounding these values must be specified. The operating conditions of the machinery during measurement and the measuring methods used must be described.

Where the workstation(s) are undefined or cannot be defined, A-weighted sound pressure levels must be measured at a distance of from the surface of the machinery and at a height of from the floor or access platform. The position and value of the maximum sound pressure must be indicated.

Where specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels, those Directives must be applied and the corresponding provisions of this section shall not apply;

(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons, in particular persons with active or non-active implantable medical devices, information concerning the radiation emitted for the operator and exposed persons.

1.7.4.3. Sales literature

Sales literature describing the machinery must not contradict the instructions as regards health and safety aspects. Sales literature describing the performance characteristics of machinery must contain the same information on emissions as is contained in the instructions.

2. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY

REQUIREMENTS FOR CERTAIN CATEGORIES OF MACHINERY

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).

2.1. Foodstuffs machinery and machinery for

cosmetics or pharmaceutical products

2.1.1. General

Machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products must be designed and constructed in such a way as to avoid any risk of infection, sickness or contagion.

The following requirements must be observed:

(a) materials in contact with, or intended to come into contact with, foodstuffs or cosmetics or pharmaceutical products must satisfy the conditions set down in the relevant Directives. The machinery must be designed and constructed in such a way that these materials can be cleaned before each use. Where this is not possible disposable parts must be used;

(b) all surfaces in contact with foodstuffs or cosmetics or pharmaceutical products, other than surfaces of disposable parts, must:

- be smooth and have neither ridges nor crevices which could harbour organic materials. The same applies to their joinings,

- be designed and constructed in such a way as to reduce the projections, edges and recesses of assemblies to a minimum,

- be easily cleaned and disinfected, where necessary after removing easily dismantled parts; the inside surfaces must have curves with a radius sufficient to allow thorough cleaning;

(c) it must be possible for liquids, gases and aerosols deriving from foodstuffs, cosmetics or pharmaceutical products as well as from cleaning, disinfecting and rinsing fluids to be completely discharged from the machinery (if possible, in a "cleaning" position);

(d) machinery must be designed and constructed in such a way as to prevent any substances or living creatures, in particular insects, from entering, or any organic matter from accumulating in, areas that cannot be cleaned;

(e) machinery must be designed and constructed in such a way that no ancillary substances hazardous to health, including the lubricants used, can come into contact with foodstuffs, cosmetics or pharmaceutical products. Where necessary, machinery must be designed and constructed in such a way that continuing compliance with this requirement can be checked.

2.1.2. Instructions

The instructions for foodstuffs machinery and machinery for use with cosmetics or pharmaceutical products must indicate recommended products and methods for cleaning, disinfecting and rinsing, not only for easily accessible areas but also for areas to which access is impossible or inadvisable.

2.2. Portable hand-held and/or hand-guided

machinery

2.2.1. General

Portable hand-held and/or hand-guided machinery must:

- depending on the type of machinery, have a supporting surface of sufficient size and have a sufficient number of handles and supports of an appropriate size, arranged in such a way as to ensure the stability of the machinery under the intended operating conditions,

- except where technically impossible, or where there is an independent control device, in the case of handles which cannot be released in complete safety, be fitted with manual start and stop control devices arranged in such a way that the operator can operate them without releasing the handles,

- present no risks of accidental starting and/or continued operation after the operator has released the handles. Equivalent steps must be taken if this requirement is not technically feasible,

- permit, where necessary, visual observation of the danger zone and of the action of the tool with the material being processed.

The handles of portable machinery must be designed and constructed in such a way as to make starting and stopping straightforward.

2.2.1.1. Instructions

The instructions must give the following information concerning vibrations transmitted by portable hand-held and hand-guided machinery:

- the vibration total value to which the hand-arm system is subjected,

2 2

if it exceeds 2,5 m/s . Where this value does not exceed 2,5 m/s , this

must be mentioned,

- the uncertainty of measurement.

These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.

If harmonised standards are not applied, the vibration data must be measured using the most appropriate measurement code for the machinery.

The operating conditions during measurement and the methods used for measurement, or the reference of the harmonised standard applied, must be specified.

2.2.2. Portable fixing and other impact machinery

2.2.2.1. General

Portable fixing and other impact machinery must be designed and constructed in such a way that:

- energy is transmitted to the impacted element by the intermediary component that does not leave the device,

- an enabling device prevents impact unless the machinery is positioned correctly with adequate pressure on the base material,

- involuntary triggering is prevented; where necessary, an appropriate sequence of actions on the enabling device and the control device must be required to trigger an impact,

- accidental triggering is prevented during handling or in case of shock,

- loading and unloading operations can be carried out easily and safely.

Where necessary, it must be possible to fit the device with splinter guard(s) and the appropriate guard(s) must be provided by the manufacturer of the machinery.

2.2.2.2. Instructions

The instructions must give the necessary information regarding:

- the accessories and interchangeable equipment that can be used with the machinery,

- the suitable fixing or other impacted elements to be used with the machinery,

- where appropriate, the suitable cartridges to be used.

2.3. Machinery for working wood and material with

similar physical characteristics

Machinery for working wood and materials with similar physical characteristics must comply with the following requirements:

(a) the machinery must be designed, constructed or equipped in such a way that the piece being machined can be placed and guided in safety; where the piece is hand-held on a work-bench, the latter must be sufficiently stable during the work and must not impede the movement of the piece;

(b) where the machinery is likely to be used in conditions involving the risk of ejection of workpieces or parts of them, it must be designed, constructed, or equipped in such a way as to prevent such ejection, or, if this is not possible, so that the ejection does not engender risks for the operator and/or exposed persons;

(c) the machinery must be equipped with an automatic brake that stops the tool in a sufficiently short time if there is a risk of contact with the tool whilst it runs down;

(d) where the tool is incorporated into a non-fully automated machine, the latter must be designed and constructed in such a way as to eliminate or reduce the risk of accidental injury.

2.4. Machinery for pesticide application

2.4.1. Definition

"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 <*>.

--------------------------------

<*> OJ L 309, 24.11.2009, p. 1.

2.4.2. General

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.

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.

2.4.3. Controls and monitoring

It must be possible to easily and accurately control, monitor and immediately stop the pesticide application from the operating positions.

2.4.4. Filling and emptying

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.

2.4.5. Application of pesticides

2.4.5.1. Application rate

The machinery must be fitted with means of adjusting the application rate easily, accurately and reliably.

2.4.5.2. Distribution, deposition and drift 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.

2.4.5.3. Tests

In order to verify that the relevant parts of the 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.

2.4.5.4. Losses during stoppage

The machinery must be designed and constructed to prevent losses while the pesticide application function is stopped.

2.4.6. Maintenance

2.4.6.1. Cleaning

The machinery must be designed and constructed to allow its easy and thorough cleaning without contamination of the environment.

2.4.6.2. Servicing

The machinery must be designed and constructed to facilitate the changing of worn parts without contamination of the environment.

2.4.7. Inspections

It must be possible to easily connect the necessary measuring instruments to the machinery to check the correct functioning of the machinery.

2.4.8. Marking of nozzles, strainers and filters

Nozzles, strainers and filters must be marked so that their type and size can be clearly identified.

2.4.9. Indication of pesticide in use

Where appropriate, the machinery must be fitted with a specific mounting on which the operator can place the name of the pesticide in use.

2.4.10. Instructions

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 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 <*>;

--------------------------------

<*> OJ L 309, 24.11.2009, p. 71.

(j) the features of the machinery which must be inspected to ensure its correct functioning;

(k) instructions for connecting the necessary measuring instruments.

3. SUPPLEMENTARY ESSENTIAL HEALTH AND SAFETY

REQUIREMENTS TO OFFSET HAZARDS DUE TO THE MOBILITY

OF MACHINERY

Machinery presenting hazards due to its mobility must meet all the essential health and safety requirements described in this chapter (see General Principles, point 4).

3.1. General

3.1.1. Definitions

(a) "Machinery presenting hazards due to its mobility" means

- machinery the operation of which requires either mobility while working, or continuous or semi-continuous movement between a succession of fixed working locations, or

- machinery which is operated without being moved, but which may be equipped in such a way as to enable it to be moved more easily from one place to another.

(b) "Driver" means an operator responsible for the movement of a machine. The driver may be transported by the machinery or may be on foot, accompanying the machinery, or may guide the machinery by remote control.

3.2. Work positions

3.2.1. Driving position

Visibility from the driving position must be such that the driver can, in complete safety for himself and the exposed persons, operate the machinery and its tools in their foreseeable conditions of use. Where necessary, appropriate devices must be provided to remedy hazards due to inadequate direct vision.

Machinery on which the driver is transported must be designed and constructed in such a way that, from the driving positions, there is no risk to the driver from inadvertent contact with the wheels and tracks.

The driving position of ride-on drivers must be designed and constructed in such a way that a driver's cab may be fitted, provided this does not increase the risk and there is room for it. The cab must incorporate a place for the instructions needed for the driver.

3.2.2. Seating

Where there is a risk that operators or other persons transported by the machinery may be crushed between parts of the machinery and the ground should the machinery roll or tip over, in particular for machinery equipped with a protective structure referred to in section 3.4.3 or 3.4.4, their seats must be designed or equipped with a restraint system so as to keep the persons in their seats, without restricting movements necessary for operations or movements relative to the structure caused by the suspension of the seats. Such restraint systems should not be fitted if they increase the risk.

3.2.3. Positions for other persons

If the conditions of use provide that persons other than the driver may occasionally or regularly be transported by the machinery or work on it, appropriate positions must be provided which enable them to be transported or to work on it without risk.

The second and third paragraphs of section 3.2.1 also apply to the places provided for persons other than the driver.

3.3. Control systems

If necessary, steps must be taken to prevent unauthorised use of controls.

In the case of remote controls, each control unit must clearly identify the machinery to be controlled from that unit.

The remote control system must be designed and constructed in such a way as to affect only:

- the machinery in question,

- the functions in question.

Remote controlled machinery must be designed and constructed in such a way that it will respond only to signals from the intended control units.

3.3.1. Control devices

The driver must be able to actuate all control devices required to operate the machinery from the driving position, except for functions which can be safely actuated only by using control devices located elsewhere. These functions include, in particular, those for which operators other than the driver are responsible or for which the driver has to leave the driving position in order to control them safely.

Where there are pedals, they must be so designed, constructed and fitted as to allow safe operation by the driver with the minimum risk of incorrect operation. They must have a slip-resistant surface and be easy to clean.

Where their operation can lead to hazards, notably dangerous movements, the control devices, except for those with preset positions, must return to the neutral position as soon as they are released by the operator.

In the case of wheeled machinery, the steering system must be designed and constructed in such a way as to reduce the force of sudden movements of the steering wheel or the steering lever caused by shocks to the guide wheels.

Any control that locks the differential must be so designed and arranged that it allows the differential to be unlocked when the machinery is moving.

The sixth paragraph of section 1.2.2, concerning acoustic and/or visual warning signals, applies only in the case of reversing.

3.3.2. Starting/moving

All travel movements of self-propelled machinery with a ride-on driver must be possible only if the driver is at the controls.

Where, for operating purposes, machinery is fitted with devices which exceed its normal clearance zone (e.g. stabilisers, jib, etc.), the driver must be provided with the means of checking easily, before moving the machinery, that such devices are in a particular position which allows safe movement.

This also applies to all other parts which, to allow safe movement, have to be in particular positions, locked if necessary.

Where it does not give rise to other risks, movement of the machinery must depend on safe positioning of the aforementioned parts.

It must not be possible for unintentional movement of the machinery to occur while the engine is being started.

3.3.3. Travelling function

Without prejudice to road traffic regulations, self-propelled machinery and its trailers must meet the requirements for slowing down, stopping, braking and immobilisation so as to ensure safety under all the operating, load, speed, ground and gradient conditions allowed for.

The driver must be able to slow down and stop self-propelled machinery by means of a main device. Where safety so requires, in the event of a failure of the main device, or in the absence of the energy supply needed to actuate the main device, an emergency device with a fully independent and easily accessible control device must be provided for slowing down and stopping.

Where safety so requires, a parking device must be provided to render stationary machinery immobile. This device may be combined with one of the devices referred to in the second paragraph, provided that it is purely mechanical.

Remote-controlled machinery must be equipped with devices for stopping operation automatically and immediately and for preventing potentially dangerous operation in the following situations: