RECREATIONAL CRAFT REGULATIONS

RECREATIONAL CRAFT

SUBSIDIARY LEGISLATION 427.61

RECREATIONAL CRAFT REGULATIONS

18th January, 2015 *

LEGAL NOTICE 387 of 2015.

(1) The title of these regulations is the Recreational Craft

Regulations.

(2) These regulations transpose Directive 2013/53/EU of the

European Parliament and of the Council of 20 November 2013 on

recreational craft and personal watercraft and repealing Directive

94/25/EC.

(3) These regulations lay down requirements for the design and

manufacture of products referred to in regulation 3(1) and rules on

their free movement in the Union.

ESSENTIAL REQUIREMENTS

A.

Essential requirements for the design and construction of products referred

to in regulation 3(1)

1. WATERCRAFT DESIGN CATEGORIES

Design category

Wind force

Significant wave height

(Beaufort scale)

(H ⅓, metres)

A

exceeding 8

exceeding 4

B

up to, and including, 8

up to, and including, 4

C

up to, and including, 6

up to, and including, 2

D

up to, and including, 4

up to, and including, 0,3

Explanatory notes

A.

A recreational craft given design category A is considered to be designed for

winds that may exceed wind force 8 (Beaufort scale) and significant wave height of

4 m and above but excluding abnormal conditions, such as storm, violent storm,

hurricane, tornado and extreme sea conditions or rogue waves.

B.

A recreational craft given design category B is considered to be designed for

a wind force up to, and including, 8 and significant wave height up to, and including,

4 m.

C.

A watercraft given design category C is considered to be designed for a wind

force up to, and including, 6 and significant wave height up to, and including, 2 m.

D. A watercraft given design category D is considered to be designed for a

wind force up to, and including, 4 and significant wave height up to, and including,

0,3 m, with occasional waves of 0,5 m maximum height.

Watercraft in each design category must be designed and constructed to withstand

the parameters in respect of stability, buoyancy, and other relevant essential

requirements listed in this Schedule, and to have good handling characteristics.

2. GENERAL REQUIREMENTS

2.1. Watercraft identification

Each watercraft shall be marked with an identification number including the

following information

(1) country code of the manufacturer,

(2) unique code of the manufacturer assigned by the authority for transport

in Malta,

(3) unique serial number,

(4) month and year of production,

(5) model year.

Detailed requirements for the identification number referred to in the first

paragraph are set out in the relevant harmonised standard.

2.2. Watercraft builder’s plate

Each watercraft shall carry a permanently affixed plate mounted separately from

the watercraft identification number, containing at least the following information

(a) manufacturer’s name, registered trade name or registered trade mark, as

well as contact address;

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(b) CE marking, as provided for in regulation 17;

(c) watercraft design category in accordance with Section 1;

(d) manufacturer’s maximum recommended load derived from point 3.6

excluding the weight of the contents of the fixed tanks when full;

(e) number of persons recommended by the manufacturer for which the

watercraft was designed.

In the case of post-construction assessment, the contact details and the

requirements referred to in point (a) shall include those of the notified body which

has carried out the conformity assessment.

2.3. Protection from falling overboard and means of reboarding

Watercraft shall be designed to minimise the risks of falling overboard and to

facilitate reboarding. Means of reboarding shall be accessible to or deployable by a

person in the water unaided.

2.4. Visibility from the main steering position

For recreational craft, the main steering position shall give the operator, under

normal conditions of use (speed and load), good all-round visibility.

2.5. Owner’s manual

Each product shall be provided with an owner ’s manual in accordance with

regulation 8(7) and regulation 10(4). That manual shall provide all the information

necessary for safe use of the product drawing particular attention to set up,

maintenance, regular operation, prevention of risks and risk management.

3. INTEGRITY AND STRUCTURAL REQUIREMENTS

3.1. Structure

The choice and combination of materials and its construction shall ensure that the

watercraft is strong enough in all respects. Special attention shall be paid to the

design category in accordance with Section 1, and the manufacturer’s maximum

recommended load in accordance with point 3.6.

3.2. Stability and freeboard

The watercraft shall have sufficient stability and freeboard considering its design

c a t e g o r y i n a c c o r d a n c e w i t h S e c t i o n 1 a n d t h e m a n u f a c t u r e r ’s m a x i m u m

recommended load in accordance with point 3.6.

3.3. Buoyancy and flotation

The watercraft shall be constructed as to ensure that it has buoyancy

characteristics appropriate to its design category in accordance with Section 1 and

the manufacturer’s maximum recommended load in accordance with point 3.6. All

habitable multihull recreational craft susceptible of inversion shall have sufficient

buoyancy to remain afloat in the inverted position.

Watercraft of less than 6 metres in length that are susceptible to swamping when

used in their design category shall be provided with appropriate means of flotation in

the swamped condition.

3.4. Openings in hull, deck and superstructure

Openings in hull, deck(s) and superstructure shall not impair the structural

integrity of the watercraft or its weather tight integrity when closed.

Windows, port lights, doors and hatch covers shall withstand the water pressure

likely to be encountered in their specific position, as well as point loads applied by

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the weight of persons moving on deck.

Through hull fittings designed to allow water passage into the hull or out of the

h u l l , b e l o w t h e w a t e r l i n e c o r r e s p o n d i n g t o t h e m a n u f a c t u r e r ’s ma x i m u m

recommended load in accordance with point 3.6, shall be fitted with a means of

shutoff which shall be readily accessible.

3.5. Flooding

All watercraft shall be designed so as to minimise the risk of sinking.

Where appropriate, particular attention shall be paid to

(a) cockpits and wells, which should be self-draining or have other means

of keeping water out of the watercraft interior;

(b) ventilation fittings;

(c) removal of water by pumps or other means.

3.6. Manufacturer’s maximum recommended load

The manufacturer ’s maximum recommended load (fuel, water, provisions,

miscellaneous equipment and people (in kilograms)) for which the watercraft was

designed, shall be determined in accordance with the design category (Section 1),

stability and freeboard (point 3.2) and buoyancy and flotation (point 3.3).

3.7. Life raft stowage

All recreational craft of design categories A and B, and recreational craft of design

categories C and D longer than 6 metres shall be provided with one or more stowage

points for a life raft (life rafts) large enough to hold the number of persons the

recreational craft was designed to carry as recommended by the manufacturer. Life

raft stowage point(s) shall be readily accessible at all times.

3.8. Escape

All habitable multihull recreational craft susceptible of inversion shall be

provided with viable means of escape in the event of inversion. Where there is a

means of escape provided for use in the inverted position, it shall not compromise

the structure (point 3.1), the stability (point 3.2) or buoyancy (point 3.3) whether the

recreational craft is upright or inverted.

Every habitable recreational craft shall be provided with viable means of escape in

the event of fire.

3.9. Anchoring, mooring and towing

All watercraft, taking into account their design category and their characteristics,

shall be fitted with one or more strong points or other means capable of safely

accepting anchoring, mooring and towing loads.

4. HANDLING CHARACTERISTICS

The manufacturer shall ensure that the handling characteristics of the watercraft

are satisfactory with the most powerful propulsion engine for which the watercraft is

designed and constructed. For all propulsion engines, the maximum rated engine

power shall be declared in the owner’s manual.

5. INSTALLATION REQUIREMENTS

5.1. Engines and engine compartments

5.1.1. Inboard engine

All inboard mounted engines shall be placed within an enclosure separated from

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living quarters and installed so as to minimise the risk of fires or spread of fires as

well as hazards from toxic fumes, heat, noise or vibrations in the living quarters.

Engine parts and accessories that require frequent inspection and/or servicing

shall be readily accessible.

The insulating materials inside the engine compartment shall not sustain

combustion.

5.1.2. Ventilation

The engine compartment shall be ventilated. The ingress of water into the engine

compartment through openings must be minimised.

5.1.3. Exposed parts

Unless the engine is protected by a cover or its own enclosure, exposed moving or

hot parts of the engine that could cause personal injury shall be effectively shielded.

5.1.4. Outboard propulsion engine starting

Every outboard propulsion engine fitted on any watercraft shall have a device to

prevent the engine being started in gear, except

(a) when the engine produces less than 500 Newton’s (N) of static thrust;

(b) when the engine has a throttle limiting device to limit thrust to 500 N at

the time of starting the engine.

5.1.5. Personal watercraft running without driver

Personal watercraft shall be designed either with an automatic propulsion engine

cut-off or with an automatic device to provide reduced speed, circular, forward

movement when the driver dismounts deliberately or falls overboard.

5.1.6. Tiller-controlled outboard propulsion engines shall be equipped with an

emergency stopping device which can be linked to the helmsman.

5.2. Fuel system

5.2.1. General

The filling, storage, venting and fuel-supply arrangements and installations shall

be designed and installed so as to minimise the risk of fire and explosion.

5.2.2. Fuel tanks

Fuel tanks, lines and hoses shall be secured and separated or protected from any

source of significant heat. The material the tanks are made of and their method of

construction shall be in accordance with their capacity and the type of fuel.

Petrol fuel tank spaces shall be ventilated.

Petrol fuel tanks shall not form part of the hull and shall be

(a) protected against fire from any engine and from all other sources of

ignition;

(b) separated from living quarters.

Diesel fuel tanks may be integral with the hull.

5.3. Electrical system

Electrical systems shall be designed and installed so as to ensure proper operation

of the watercraft under normal conditions of use and shall be such as to minimise

risk of fire and electric shock.

All electrical circuits, except engine starting circuits supplied from batteries, shall

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remain safe when exposed to overload.

Electric propulsion circuits shall not interact with other circuits in such a way that

either would fail to operate as intended.

Ventilation shall be provided to prevent the accumulation of explosive gases

which might be emitted from batteries. Batteries shall be firmly secured and

protected from ingress of water.

5.4. Steering system

5.4.1. General

Steering and propulsion control systems shall be designed, constructed and

installed in order to allow the transmission of steering loads under foreseeable

operating conditions.

5.4.2. Emergency arrangements

Every sailing recreational craft and single-propulsion engine non-sailing

recreational craft with remote-controlled rudder steering systems shall be provided

with emergency means of steering the recreational craft at reduced speed.

5.5. Gas system

Gas systems for domestic use shall be of the vapour-withdrawal type and shall be

designed and installed so as to avoid leaks and the risk of explosion and be capable

of being tested for leaks. Materials and components shall be suitable for the specific

gas used to withstand the stresses and exposures found in the marine environment.

Each gas appliance intended by the manufacturer for the application for which it is

used shall be so installed in accordance with the manufacturer’s instructions. Each

gas-consuming appliance must be supplied by a separate branch of the distribution

system, and each appliance must be controlled by a separate closing device.

Adequate ventilation must be provided to prevent hazards from leaks and products of

combustion.

All watercraft with a permanently installed gas system shall be fitted with an

enclosure to contain all gas cylinders. The enclosure shall be separated from the

living quarters, accessible only from the outside and ventilated to the outside so that

any escaping gas drains overboard.

In particular, any permanently installed gas system shall be tested after

installation.

5.6. Fire protection

5.6.1. General

The type of equipment installed and the layout of the watercraft shall take account

of the risk and spread of fire. Special attention shall be paid to the surroundings of

open flame devices, hot areas or engines and auxiliary machines, oil and fuel

overflows, uncovered oil and fuel pipes and routing of electrical wiring in particular

away from heat sources and hot areas.

5.6.2. Fire-fighting equipment

Recreational craft shall be supplied with fire-fighting equipment appropriate to

the fire hazard, or the position and capacity of fire-fighting equipment appropriate to

the fire hazard shall be indicated. The craft shall not be put into service until the

appropriate fire-fighting equipment is in place. Petrol engine compartments shall be

protected by a fire extinguishing system that avoids the need to open the

compartment in the event of fire. Where fitted, portable fire extinguishers shall be

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readily accessible and one shall be so positioned that it can easily be reached from

the main steering position of the recreational craft.

5.7. Navigation lights, shapes and sound signals

Where navigation lights, shapes and sound signals are fitted, they shall comply

with the 1972 COLREG (The International Regulations for Preventing Collisions at

Sea) or CEVNI (European Code for Interior Navigations for inland waterways)

Regulations as appropriate.

5.8. Discharge prevention and installations facilitating the delivery ashore of

waste

Watercraft shall be constructed so as to prevent the accidental discharge of

pollutants (oil, fuel, etc.) overboard.

Any toilet fitted in a recreational craft shall be connected solely to a holding tank

system or water treatment system.

Recreational craft with installed holding tanks shall be fitted with a standard

discharge connection to enable pipes of reception facilities to be connected with the

recreational craft discharge pipeline.

In addition, any through-the-hull pipes for human waste shall be fitted with valves

which are capable of being secured in the closed position.

B.

Essential requirements for exhaust emissions from propulsion engines

Propulsion engines shall comply with the essential requirements for exhaust

emissions set out in this Part.

1. PROPULSION ENGINE IDENTIFICATION

1.1. Each engine shall be clearly marked with the following information

(a) engine manufacturer’s name, registered trade name or registered trade

mark and contact address; and, if applicable, the name and contact

address of the person adapting the engine;

(b) engine type, engine family, if applicable;

(c) a unique engine serial number;

(d) CE marking, as provided for in regulation 17.

1.2. The marks referred to in point 1.1 must be durable for the normal life of the

engine and must be clearly legible and indelible. If labels or plates are used, they

must be attached in such a manner that the fixing is durable for the normal life of the

engine, and the labels/plates cannot be removed without destroying or defacing

them.

1.3. The marks must be secured to an engine part necessary for normal engine

operation and not normally requiring replacement during the engine life.

1.4. The marks must be located so as to be readily visible after the engine has

been assembled with all the components necessary for engine operation.

2. EXHAUST EMISSION REQUIREMENTS

Propulsion engines shall be designed, constructed and assembled so that when

correctly installed and in normal use, emissions shall not exceed the limit values

obtained from point 2.1, Table 1 and point 2.2, Tables 2 and 3

2.1. Values applying for the purposes of regulation 2(3) and Table 2 of point 2.2

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Table 1

(g/kWh)

Type

Carbon monoxide

Hydrocarbons

N i t r o g e n Particulates

oxides

PT

NO x

CO = A + B/P

n

HC = A + B/P n

N

N

A

B

n

A

B

n

Tw o -

150,0

600,0

1,0

30,0

100,0 0,75

10,0

Not

stroke

applicable

spark

ignition

Four-

150,0

600,0

1,0

6,0

50,0

0,75

15,0

Not

stroke

applicable

spark

ignition

C o m p r e s - 5,0

1,5

2,0

0,5

9,8

1,0

sion

ignition

Where A, B and n are constants in accordance with the table, PN is the rated

engine power in kW.

2.2. Values applying from 18 January 2016

Table 2

Exhaust emission limits for compression ignition (CI) engines 1

Swept Volume SV Rated Engine Power Particulates

Hydrocarbons

+

(L/cyl)

P N

PT

Nitrogen Oxides

(kW)

(g/kWh)

HC + NO x

(g/kWh)

SV < 0,9

P N < 37

The values referred to in table 1

37 < P N < 75 2

0,30

4,7

75 < P N < 3 700

0,15

5,8

0,9 < SV < 1,2

P N < 3 700

0,14

5,8

1,2 < SV < 2,5

0,12

5,8

2,5 < SV < 3,5

0,12

5,8

3,5 < SV < 7,0

0,11

5,8

1. Any compression-ignition engine shall not exceed a Carbon monoxide (CO) emission limit of 5,0 g/

kWh

2. Alternatively, compression-ignition engines with rated engine power at or above 37 kW and below 75

kW and with a swept volume below 0,9 L/cyl shall not exceed a PT emission limit of 0,20 g/kWh and a

combined emission limit of 5,8 g/kWh.

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Table 3

Exhaust emission limits for spark ignition (SI) engines

Type of engine

Rated

E n g i n e Carbon monoxide H y d r o c a r b o n s +

Power P N (kW)

CO

Nitrogen Oxides

(g/kWh)

HC + NO x

(g/kWh)

S t e r n - d r i v e a n d P N < 373

inboard engines

373 < P N < 485

P N > 485

Outboard engines P N < 4.3

500 - (5.0 x P N )

and PWC engines

4,3 < P N < 40

500 - (5.0 x P N )

(

)

15,7 +

P 0,9

N

P N > 40

15,7 + (

)

P 0,9

N

2.3. Test cycles

Test cycles and weighting factors to be applied

The following requirements of ISO standard 8178-4:2007 shall be used, taking

into account the values set out in the table below.

For variable speed CI engines test cycle E1 or E5 shall be applied or alternatively,

above 130 kW, test cycle E3 may be applied. For variable speed SI engines test cycle

E4 shall be applied.

Cycle E1, Mode number

Speed

Rated speed

Intermediate speed

Low-idle speed

Torque, %

Weighting factor

0,08

0,11

0,19

0,32

0,3

Speed

Rated speed

Intermediate speed

Low-idle speed

Cycle E3, Mode number

Speed, %

Power, %

Weighting factor

0,2

0,5

0,15

0,15

Cycle E4, Mode number

Speed, %

Idle

Torque, %

71,6

46,5

25,3

Weighting factor

0,06

0,14

0,15

0,25

0,40

Cycle E5, Mode number

Speed, %

Idle

Power, %

Weighting factor

0,08

0,13

0,17

0,32

0,3

Notified bodies may accept tests carried out on the basis of other tests cycles as

specified in a harmonised standard and as applicable for the engine duty cycle.

2.4. Application of the propulsion engine family and choice of parent propulsion

engine

The engine manufacturer shall be responsible for defining those engines from his

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range which are to be included in an engine family.

A parent engine shall be selected from an engine family in such a way that its

emissions characteristics are representative for all engines in that engine family. The

engine incorporating those features that are expected to result in the highest specific

emissions (expressed in g/kWh), when measured on the applicable test cycle, should

normally be selected as the parent engine of the family.

2.5. Test fuels

The test fuel used for exhaust emission testing shall meet the following

characteristics

Petrol Fuels

Property

RF-02-99

RF-02-03

Unleaded

Unleaded

min

max

min

max

Research Octane Number (RON)

-

-

Motor Octane Number (MON)

-

-

Density at 15ºC (kg/m 3 )

Initial boiling point (ºC)

Mass fraction of sulphur (mg/kg)

-

-

Lead content (mg/l)

-

-

Reid vapour pressure (kPa)

-

-

Vapour pressure (DVPE) (kPa)

-

-

Diesel Fuels

Property

RF-06-99

RF-06-03

min

max

min

max

Cetane number

Density at 15ºC (kg/m 3 )

Final boiling point (ºC)

-

-

Flash point (ºC)

-

-

Mass fraction of sulphur (mg/kg)

To

b e 300 (50)

-

reported

Mass fraction of ash (%)

To

b e 0,01

-

0,01

reported

Notified bodies may accept tests carried out on the basis of other tests fuel as

specified in a harmonised standard.

3. DURABILITY

The manufacturer of the engine shall supply engine installation and maintenance

instructions, which if applied should mean that the engine in normal use will

continue to comply with the limits set out in points 2.1 and 2.2 throughout the

normal life of the engine and under normal conditions of use.

This information shall be obtained by the engine manufacturer by use of prior

endurance testing, based on normal operating cycles, and by calculation of

component fatigue so that the necessary maintenance instructions may be prepared

by the manufacturer and issued with all new engines when first placed on the market.

The normal life of the engine is as follows

(a) For CI engines: 480 hours of operation or 10 years, whichever occurs

first;

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(b) For SI inboard or stern drive engines with or without integral exhaust

(i) for the engine category P N < 373 kW

: 480 hours of operation or 10 years, whichever occurs first,

(ii) for engines in the category 373 < P N < 485 kW

: 150 hours of operation or three years, whichever occurs first,

(iii) for the engine category P N < 485 kW

: 50 hours of operation or one year, whichever occurs first;

(c) personal watercraft engines: 350 hours of operation or five years,

whichever occurs first;

(d) outboard engines: 350 hours of operation or 10 years, whichever occurs

first

4. OWNER’S MANUAL

Each engine shall be provided with an owner’s manual in a language or languages

which can be easily understood by consumers and other end-users, as determined by

the Member State in which the engine is to be marketed.

The owner’s manual shall

(a) provide instructions for the installation, use and maintenance needed to

assure the proper functioning of the engine to meet the requirements of

Section 3 (Durability);

(b) specify the power of the engine when measured in accordance with the

harmonised standard.

C.

Essential requirements for noise emissions

Recreational craft with inboard or stern drive engines without integral exhaust,

personal watercraft and outboard engines and stern drive engines with integral

exhaust shall comply with the essential requirements for noise emissions set out in

this Part.

1. NOISE EMISSION LEVELS

1.1. Recreational craft with inboard or stern drive engines without integral

exhaust, personal watercraft and outboard engines and stern drive engines with

integral exhaust shall be designed, constructed and assembled so that noise

emissions shall not exceed the limit values in the following table

Rated Engine Power

Maximum Sound Pressure Level = L pASmax

(single engine)

In dB

In kW

P N < 10

10 < P N < 40

P N > 40

where P N = rated engine power in kW of a single engine at rated speed and

L pASmax = maximum sound pressure level in dB.

For twin-engine and multiple-engine units of all engine types an allowance of 3

dB may be applied.

1.2. As an alternative to sound measurement tests, recreational craft with inboard

engine configuration or stern drive engine configuration, without integral exhaust,

shall be deemed to comply with the noise requirements set out in point 1.1 if they

have a Froude number of ≤ 1,1 and a Power to Displacement ratio of ≤ 40 and where

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the engine and exhaust system are installed in accordance with the engine

manufacturer’s specifications.

1.3. ‘Froude number’ F n shall be calculated by dividing the maximum

recreational craft speed V (m/s) by the square root of the waterline length lwl (m)

multiplied by a given gravitational acceleration constant, g, of 9,8 m/s 2 .

V

F n =

√ g.lwl

‘Power to Displacement ratio’ shall be calculated by dividing the rated engine

power P N (in kW) by the recreational craft’s displacement D (in tonnes)

P N

Power to Displacement ratio =

D

2. OWNER’S MANUAL

For recreational craft with inboard engine or stern drive engines without integral

exhaust and personal watercraft, the owner’s manual required under point 2.5 of Part

A, shall include information necessary to maintain the recreational craft and exhaust

system in a condition that, insofar as is practicable, will ensure compliance with the

specified noise limit values when in normal use.

For outboard engines and stern drive engines with integral exhaust, the owner’s

manual required under Section 4 of Part B shall provide the instructions necessary to

maintain the engine in a condition, that insofar as is practicable, will ensure

compliance with the specified noise limit values when in normal use.

3. DURABILITY

The provisions on the durability in Section 3 of Part B shall apply mutatis

mutandis to the compliance with the requirements on noise emissions set out in

Section 1 of this part.

Schedule II

COMPONENTS OF WATERCRAFT

(1) Ignition-protected equipment for inboard and stern drive petrol engines and

petrol tank spaces;

(2)

Start-in-gear protection devices for outboard engines;

(3)

Steering wheels, steering mechanisms and cable assemblies;

(4)

Fuel tanks intended for fixed installations and fuel hoses;

(5)

Prefabricated hatches, and port lights.

Schedule III

DECLARATION BY THE MANUFACTURER OR THE IMPORTER OF THE

PARTLY COMPLETED WATERCRAFT (REGULATION 7(2))

The declaration by the manufacturer or the importer established in the European

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Union referred to in regulation 7(2) shall contain the following

(a) the name and address of the manufacturer;

(b) the name and address of the representative of the manufacturer

established in the Union or, if appropriate, of the person responsible for

the placing on the market;

(c) a description of the partly completed watercraft;

(d) a statement that the partly completed watercraft complies with the

essential requirements that apply at this stage of construction; this shall

include references to the relevant harmonised standards used, or

references to the specifications in relation to which compliance is

declared at this stage of construction; furthermore, it is intended to be

completed by other legal or natural persons in full compliance with

these regulations.

Schedule IV

EU DECLARATION OF CONFORMITY No xxxxx *

1. No xxxxx (Product: product, batch, type, or serial number)

2. Name and address of the manufacturer or his authorised representative [The

authorised representative must also give the business name and address of the

manufacturer] or the private importer.

3. This declaration of conformity is issued under the sole responsibility of the

manufacturer or the private importer or the person referred to in Article 19(3) or (4)

of Directive 2013/53/EU.

4. Object of the declaration (identification of product allowing traceability. It

may include a photograph, where appropriate)

5. The object of the declaration described in point 4 is in conformity with the

relevant Union harmonisation legislation

6. References to the relevant harmonised standards used or references to the

other technical specifications in relation to which conformity is declared

7. Where applicable, the notified body ................. (name, number) performed

........................ (description of intervention) and issued the certificate

8. Identification of the person empowered to sign on behalf of the

manufacturer or his authorised representative

9. Additional information

The EU declaration of conformity shall include a statement of the propulsion

engine manufacturer and that of the person adapting an engine in accordance with

points (b) and (c) of regulation 7(4) that

(a) when installed in a watercraft, in accordance with the installation

instructions accompanying the engine, the engine will meet

(i) the exhaust emission requirements of these regulations;

(ii) the limits of Directive 97/68/EC as regards engines type-approved

in accordance with Directive 97/68/EC which are in compliance

* It is optional to assign a number to the declaration of conformity.

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with stage III A, stage III B or stage IV emission limits for CI

engines used in other applications than propulsion of inland

waterway vessels, locomotives and railcars, as provided for in

point 4.1.2 of Annex I to that Directive; or

(iii) the limits of Regulation (EC) No 595/2009 as regards engines

type-approved in accordance with that Regulation.

The engine must not be put into service until the watercraft into which it is to be

installed has been declared in conformity, if so required, with the relevant provision

of this Directive.

If the engine has been placed on the market during the additional transitional

period provided for in regulation 2(3), the EU declaration of conformity shall

contain an indication thereof.

Signed for and on behalf of

(place and date of issue)

(name, function) (signature)

Schedule V

EQUIVALENT CONFORMITY BASED ON POST-CONSTRUCTION

ASSESSMENT (MODULE PCA)

1. Conformity based on post-construction assessment is the procedure to assess

the equivalent conformity of a product for which the manufacturer has not assumed

the responsibility for the product’s conformity with these regulations, and whereby a

natural or legal person referred to in regulation 18(2), (3) or (4) who is placing the

product on the market or putting it into service under his own responsibility is

assuming the responsibility for the equivalent conformity of the product. This person

shall fulfill the obligations laid down in points 2 and 4 and ensure and declare on his

sole responsibility that the product concerned, which has been subject to the

provisions of point 3, is in conformity with the applicable requirements of these

regulations.

2. The person who is placing the product on the market or putting it into

service shall lodge an application for a post- construction assessment of the product

with a notified body and must provide the notified body with the documents and

technical file enabling the notified body to assess the conformity of the product with

the requirements of these regulations and any available information on the use of the

product after its first putting into service.

The person who is placing such a product on the market or putting it into service

shall keep these documents and information at the disposal of the relevant national

authorities for 10 years after the product has been assessed on its equivalent

conformity in accordance with the post-construction assessment procedure.

3. The notified body shall examine the individual product and carry out

calculations, tests and other assessments, to the extent necessary to ensure that the

equivalent conformity of the product with the relevant requirements of these

regulations is demonstrated.

The notified body shall draw up and issue a certificate and a related report of

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conformity concerning the assessment carried out and shall keep a copy of the

certificate and related report of conformity at the disposal of the national authorities

for 10 years after it has issued these documents.

The notified body shall affix its identification number next to the CE marking on

the approved product or have it affixed under its responsibility.

In case the assessed product is a watercraft, the notified body shall also have

affixed, under his responsibility, the watercraft identification number as referred to

in point 2.1 of Part A of Schedule I, whereby the field for the country code of the

manufacturer shall be used to indicate the country of establishment of the notified

body and the fields for the unique code of the manufacturer assigned by the

Authority for Transport in Malta to indicate the post- construction assessment

identification code assigned to the notified body, followed by the serial number of

the post- construction assessment certificate. The fields in the watercraft

identification number for the month and year of production and for the model year

shall be used to indicate the month and year of the post-construction assessment.

4. CE marking and EU declaration of conformity

4.1. The person who is placing the product on the market or putting it into

service shall affix the CE marking and, under the responsibility of the notified body

referred to in Section 3, the latter’s identification number to the product for which

the notified body has assessed and certified its equivalent conformity with the

relevant requirements of these regulations.

4.2. The person who is placing the product on the market or putting it into

service shall draw up an EU declaration of conformity and keep it at the disposal of

the national authorities for 10 years after the date the post-construction assessment

certificate has been issued. The declaration of conformity shall identify the product

for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant

authorities upon request.

4.3. In the case the assessed product is a watercraft, the person who is placing

the watercraft on the market or putting it into service shall affix to the watercraft the

builder’s plate described in point 2.2 of Part A of Schedule I, which shall include the

words ‘post-construction assessment’, and the watercraft identification number

described in point 2.1 of Part A of Schedule I, in accordance with the provisions set

out in Section 3.

5. The notified body shall inform the person who is placing the product on the

market or putting it into service of his obligations under this post-construction

assessment procedure.

Schedule VI

SUPPLEMENTARY REQUIREMENTS WHEN INTERNAL PRODUCTION

CONTROL PLUS SUPERVISED PRODUCTION TESTS SET OUT IN MODULE

A1 IS USED (REGULATION 23(2))

Design and construction

On one or several watercrafts representing the production of the manufacturer one

or more of the following tests, equivalent calculation or control shall be carried out

by the manufacturer or on his behalf

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(a) test of stability in accordance with point 3.2 of Part A of Schedule I;

(b) test of buoyancy characteristics in accordance with point 3.3 of Part A

of Schedule I.

Noise emissions

For recreational craft fitted with inboard or stern drive engines without integral

exhaust and for personal watercraft, on one or several watercraft representing the

production of the watercraft manufacturer, the sound emission tests defined in Part C

of Annex I shall be carried out by the watercraft manufacturer, or on his behalf,

under the responsibility of a notified body chosen by the manufacturer.

For outboard engines and stern drive engines with integral exhaust, on one or

several engines of each engine family representing the production of the engine

manufacturer, the sound emission tests defined in Part C of Schedule I shall be

carried out by the engine manufacturer, or on his behalf, under the responsibility of a

notified body chosen by the manufacturer.

Where more than one engine of an engine family is tested, the statistical method

described in Schedule VII shall be applied to ensure conformity of the sample.

Schedule VII

CONFORMITY OF PRODUCTION ASSESSMENT FOR EXHAUST

AND NOISE EMISSIONS

1. For verifying the conformity of an engine family, a sample of engines shall

be taken from the series. The manufacturer shall decide the size (n) of the sample, in

agreement with the notified body.

2. The arithmetical mean X of the results obtained from the sample shall be

calculated for each regulated component of the exhaust and noise emission. The

production of the series shall be deemed to conform to the requirements (‘pass

decision’) if the following condition is met

X + k.S < L

S is standard deviation, where

Σ

S 2 =

(x - X) 2 / (n - 1)

X = the arithmetical mean of the results obtained from the sample

x = the individual results obtained from the sample

L = the appropriate limit value

n = the number of engines in the sample

k = statistical factor depending on n (see table below)

n

k

0,973

0,613

0,489

0,421

0,376

0,342

0,317

0,296

0,279

n

k

0,265

0,253

0,242

0,233

0,224

0,216

0,210

0,203

0,198

If n > 20 then k = 0,860 /

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Schedule VIII

SUPPLEMENTARY PROCEDURE TO BE APPLIED UNDER CONFORMITY TO

TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)

In the cases referred to in regulation 23(5) when the quality level appears

unsatisfactory, the following procedure shall apply

An engine is taken from the series and subjected to the test described in Part B of

Schedule I. Test engines shall have been run in, partially or completely, in

accordance with the manufacturer’s specifications. If the specific exhaust emissions

of the engine taken from the series exceed the limit values in accordance with Part B

of Schedule I, the manufacturer may ask for measurements to be done on a sample of

engines taken from the series and including the engine originally taken. To ensure

the conformity of the sample of engines with the requirements of these regulations,

the statistical method described in Schedule VII shall be applied.

Schedule IX

SUPPLEMENTARY PROCEDURE TO BE APPLIED UNDER CONFORMITY TO

TYPE BASED ON INTERNAL PRODUCTION CONTROL (MODULE C)

The technical documentation referred to in regulation 8(2) and regulation 24 shall,

as far as it is relevant for the assessment, contain the following

(a) A general description of the type;

(b) Conceptual design and manufacturing drawings and schemes of

components, sub-assemblies, circuits, and other relevant data;

(c) Descriptions and explanations necessary for the understanding of said

drawings and schemes and the operation of the product;

(d) A list of the standards referred to in regulation 15, applied in full or in

part, and descriptions of the solutions adopted to fulfil the essential

requirements when the standards referred to in regulation 15 have not

been applied;

(e) Results of design calculations made, examinations carried out and other

relevant data;

(f) Test reports, or calculations namely on stability in accordance with

point 3.2 of Part A of Schedule I and on buoyancy in accordance with

point 3.3 of Part A of Schedule I;

(g) Exhaust emissions test reports demonstrating compliance with Section 2

of Part B of Schedule I;

(h) Sound emissions test reports demonstrating compliance with Section 1

of Part C of Schedule I.

(1) These regulations shall apply as from 18th January

2016. (2) The making available on the market or the putting into

service of products covered by the Recreational Craft Regulations,

2005, which are in conformity with these regulations and which

were placed on the market or put into service before 18 January

2017 shall not be impeded.

(3) The making available on the market or the putting into

service of outboard SI propulsion engines with power equal to or

less than 15 kW which comply with the stage I exhaust emission

limits laid down in point 2.1 of Part B of Schedule I and which

were manufactured by small and medium-sized enterprises as

defined in Commission Recommendation 2003/361/EC and placed

on the market before 18 January 2020 shall not be impeded.

(1)

These regulations shall apply to the following

products

(a) recreational craft and partly completed recreational

craft;

(b) personal watercraft and partly completed personal

watercraft;

(c) components listed in Schedule II when placed on the

Union market separately, hereinafter referred to as

"components";

(d) propulsion engines which are installed or specifically

intended for installation on or in watercraft;

(e) propulsion engines installed on or in watercraft that

are subject to a major engine modification;

(f) watercraft that are subject to major craft conversion.

*see regulation 2(1).

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(2)

These regulations shall not apply to the following products

(a) with regard to the design and construction

requirements set out in Part A of Schedule I

(i) watercraft intended solely for racing, including

rowing racing boats and training rowing boats,

labelled as such by the manufacturer;

(ii) canoes and kayaks designed to be propelled

solely by human power, gondolas and pedalos;

(iii) surfboards designed solely to be propelled by

wind and to be operated by a person or persons

standing;

(iv) surfboards;

(v) original historical watercraft and individual

replicas thereof designed before 1950, built

predominantly with the original materials and

labelled as such by the manufacturer;

(vi) experimental watercraft, provided that they are

not placed on the Union market;

(vii) watercraft built for own use, provided that they

are not subsequently placed on the Union market

during a period of five years from the putting

into service of the watercraft;

(viii) watercraft specifically intended to be crewed

and to carry passengers for commercial

purposes, without prejudice to sub-regulation

(3), regardless of the number of passengers;

(ix) submersibles;

(x) air cushion vehicles;

(xi) hydrofoils;

(xii) external combustion steam powered watercraft,

fuelled by coal, coke, wood, oil or gas;

(xiii)

amphibious vehicles, i.e. wheeled or track-

laying motor vehicles, which are able to operate

both on water and on solid land;

(b) with regard to exhaust emission requirements set out

in Part B of Schedule I

(i) propulsion engines installed or specifically

intended for installation on the following

products

•

watercraft intended solely for racing and

labelled as such by the manufacturer;

•

experimental watercraft, provided that

they are not placed on the Union market;

•

watercraft specifically intended to be

crewed and to carry passengers for

commercial purposes, without prejudice to

sub-regulation (3), regardless of the

number of passengers;

•

submersibles;

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•

air cushion vehicles;

•

hydrofoils;

•

amphibious vehicles, i.e. wheeled or track-

laying motor vehicles, which are able to

operate both on water and on solid land;

(ii) original and individual replicas of historical

propulsion engines, which are based on a pre-

1950 design, not produced in series and fitted on

watercraft referred to in paragraph (a)(v) or

(vii);

(iii) propulsion engines built for own use provided

that they are not subsequently placed on the

Union market during a period of five years from

the putting into service of the watercraft;

(c) with regard to noise emission requirements referred to

in Part C of Schedule I

(i) all watercraft referred in paragraph (b);

(ii) watercraft built for own use, provided that they

are not subsequently placed on the Union market

during a period of five years from the putting

into service of the watercraft.

(3) The fact that the same watercraft could also be used for

charter or for sports and leisure training shall not prevent it being

covered by these regulations when it is placed on the Union market

for recreational purposes.

For the purpose of these regulations, the following

definitions shall apply

"accreditation" means accreditation as defined in point 10 of

Article 2 of Regulation (EC) No 765/2008;

"authorised representative" means any natural or legal person

established within the Union who has received a written mandate

from the manufacturer to act on his behalf in relation to specified

tasks;

"CE marking" means a marking by which the manufacturer

indicates that the product is in conformity with the applicable

requirements set out in Union harmonisation legislation providing

for its affixing;

"conformity assessment" means the process demonstrating

whether the requirements of this Directive relating to a product

have been fulfilled;

"conformity assessment body" means a body that performs

conformity assessment activities including calibration, testing,

certification and inspection;

"the Directive" means Directive 2013/53/EU of the European

Parliament and of the Council of 20 November 2013 on

recreational craft and personal watercraft and repealing Directive

94/25/EC;

"distributor" means any natural or legal person in the supply

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chain, other than the manufacturer or the importer, who makes a

product available on the market;

"economic operators" means the manufacturer, the authorised

representative, the importer and the distributor;

"engine family" means the manufacturer’s grouping of engines

which, through their design, have similar exhaust or noise emission

characteristics;

"essential requirements" means the requirements in Annex I of

the Directive, which is set out in Schedule I;

"harmonised standard" means harmonised standard as defined in

point (c) of Article 2(1) of Regulation (EU) No 1025/2012;

"hull length" means the length of the hull measured in

accordance with the harmonised standard;

"importer" means any natural or legal person established within

the Union who places a product from a third country on the Union

market;

"major craft conversion" means a conversion of a watercraft

which changes the means of propulsion of the watercraft, involves

a major engine modification, or alters the watercraft to such an

extent that it may not meet the applicable essential safety and

environmental requirements laid down in these regulations;

"major engine modification" means the modification of a

propulsion engine which could potentially cause the engine to

exceed the emission limits set out in Part B of Schedule I or

increases the rated power of the engine by more than 15%;

"making available on the market" means any supply of a product

for distribution, consumption or use on the Union market in the

course of a commercial activity, whether in return for payment or

free of charge;

"manufacturer" means any natural or legal person who

manufactures a product or has such a product designed or

manufactured, and markets that product under his name or

trademark;

"market surveillance" means the activities carried out and

measures taken by public authorities to ensure that products

comply with the applicable requirements set out in Union

harmonisation legislation and do not endanger health, safety or any

other aspect of public interest protection;

"means of propulsion" means the method by which the watercraft

is propelled;

"the National Accreditation Board (Malta)" means the National

Accreditation Board (Malta) established in terms of regulation 3 of

the National Accreditation Board (Malta) (Establishment)

Regulations;

"personal watercraft" means a watercraft intended for sports and

leisure purposes of less than 4m in hull length which uses a

propulsion engine having a water jet pump as its primary source of

propulsion and designed to be operated by a person or persons

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sitting, standing or kneeling on, rather than within the confines of,

a hull;

"placing on the market" means the first making available of a

product on the Union market;

"private importer" means any natural or legal person established

within the Union who imports in the course of a non-commercial

activity a product from a third country into the Union with the

intention of putting it into service for his own use;

"propulsion engine" means any spark or compression ignition,

internal combustion engine used directly or indirectly for

propulsion purposes;

"putting into service" means the first use of a product covered by

this Directive in the Union by its end-user;

"recall" means any measure aimed at achieving the return of a

product that has already been made available to the end-user;

"recreational craft" means any watercraft of any type, excluding

personal watercraft, intended for sports and leisure purposes of hull

length from 2,5m to 24m, regardless of the means of propulsion;

"the Technical Regulations Division" means the Technical

Regulations Division within the Malta Competition and Consumer

Affairs Authority as established by the Malta Competition and

Consumer Affairs Authority Act;

"Union harmonisation legislation" means any Union legislation

harmonising the conditions for the marketing of products;

"watercraft" means any recreational craft or personal watercraft;

"watercraft built for own use’ means a watercraft predominantly

built by its future user for his own use.

A boat built by a professional company for a private person

under a contracted agreement, is deemed to fall under these

regulations and will have to comply with the essential requirements

of the regulations and the applicable conformity assessment

procedures;

"withdrawal" means any measure aimed at preventing a product

in the supply chain from being made available on the market.

(1) The products referred to in regulation 3(1) may be

made available or put into service only if they do not endanger the

health and safety of persons, property or the environment when

correctly maintained and used in accordance with their intended

purpose, and only on the condition that they meet the applicable

essential requirements set out in Schedule I.

(2) Products referred to in regulation 3(1) shall not be made

available on the market or put into service unless they comply with

the requirements of sub-regulation (1).

The provisions of these regulations shall not prevent from

adopting provisions concerning navigation on certain waters for the

purpose of protection of the environment, the fabric of waterways,

and ensuring safety of waterways, provided that those provisions

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do not require modification to watercraft conforming to these

regulations and that those provisions are justified and

proportionate.

(1) Without prejudice to regulation 6, the making available

on the Maltese market or the putting into service in the Maltese

territory of watercrafts complying with these regulations shall not

be impeded.

(2) The making available on the market of partly-completed

watercraft where the manufacturer or the importer declares, in

accordance with Schedule III, that they are intended to be

completed by others, shall not be impeded.

(3) The making available on the market or putting into service

of components complying with these regulations which are

intended to be incorporated into watercraft, in accordance with the

declaration of the manufacturer or the importer, as referred to in

regulation 16, shall not be impeded.

(4) The making available on the market or putting into service

of any of the following propulsion engines shall not be impeded

(a) engines, whether or not installed in watercraft,

complying with these regulations;

(b) engines installed in watercraft and type-approved in

accordance with Directive 97/68/EC which are in

compliance with stage III A, stage III B or stage IV

emission limits for CI engines used in other

applications than propulsion of inland waterway

vessels, locomotives and railcars, as provided for in

point 4.1.2. of Annex I to that Directive, complying

with these regulations, with the exclusion of the

exhaust emission requirements set out in Part B of

Schedule I;

(c) engines installed in watercraft and type-approved in

accordance with Regulation (EC) No 595/2009,

complying with these regulations, with the exclusion

of the exhaust emission requirements set out in Part B

of Schedule I.

(5) Sub-regulation (4)(b) and (c) shall apply subject to the

condition that where an engine is adapted for installation in a

watercraft, the person undertaking the adaptation shall ensure that

full account is taken of the data and other information available

from the engine manufacturer in order to ensure that, when

installed in accordance with the installation instructions provided

by the person adapting the engine, that engine will continue to meet

the exhaust emission requirements of either Directive 97/68/EC or

of Regulation (EC) No 595/2009, as declared by the engine

manufacturer. The person adapting the engine shall declare, as

referred to in regulation 16, that the engine will continue to meet

the exhaust emission requirements of either Directive 97/68/EC or

of Regulation (EC) No 595/2009, as declared by the engine

manufacturer, when installed in accordance with the installation

instructions supplied by the person adapting the engine.

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(6) At trade fairs, exhibitions, demonstrations and other similar

events, the showing of products referred to in regulation 3(1) which

do not comply with these regulations, provided that a visible sign

clearly indicates that such products do not comply with these

regulations and will not be made available or put into service in the

Union until they have been made to comply, shall not be impeded.

(1) When placing their products on the market,

manufacturers shall ensure that they have been designed and

manufactured in accordance with the requirements set out in

regulation 5(1) and in Schedule I.

(2) Manufacturers shall draw up the technical documentation in

accordance with regulation 24 and carry out the conformity

assessment procedure applicable or have it carried out in

accordance with regulations 18 to 21 and regulation 23.

Where compliance of a product with the applicable

requirements has been demonstrated by that procedure,

manufacturers shall draw up a declaration, as referred to in

regulation 16 and mark and affix the CE marking, as set out in

regulation 17.

(3) Manufacturers shall keep the technical documentation and a

copy of the declaration, as referred to in regulation 16, for ten years

after the product has been placed on the market.

(4) Manufacturers shall ensure that procedures are in place for

series production to remain in conformity with these regulations.

Changes in product design or characteristics and changes in the

harmonised standards by reference to which conformity of a

product is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented

by a product, manufacturers shall, to protect the health and safety

of consumers, carry out sample testing of products made available

on the market, investigate, and, if necessary, keep a register of

complaints, of non-conforming products and product recalls, and

shall keep distributors informed of any such monitoring.

(5) Manufacturers shall ensure that their products bear a type,

batch or serial number or other element allowing their

identification, or, where the size or nature of the components does

not allow it, that the required information is provided on the

packaging or in a document accompanying the product.

(6) Manufacturers shall indicate their name, registered trade

name or registered trade mark and the address at which they can be

contacted on the product or, where that is not possible, on its

packaging or in a document accompanying the product. The

address shall indicate a single point at which the manufacturer can

be contacted.

(7) Manufacturers shall ensure that the product is accompanied

by instructions and safety information in the owner’s manual in at

least the Maltese or the English language.

(8) Manufacturers who consider or have reason to believe that

a product which they have placed on the market is not in

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conformity with these regulations shall immediately take the

necessary corrective measures to bring that product into

conformity, to withdraw it or recall it, if appropriate. Furthermore,

where the product presents a risk, manufacturers shall immediately

inform the competent national authorities of the Member States in

which they made the product available to that effect, giving details,

in particular, of the non-compliance and of any corrective measures

taken.

(9) Manufacturers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of the

product, in at least the Maltese or the English language. They shall

cooperate with that authority, at its request, on any action taken to

eliminate the risks posed by products which they have placed on

the market.

(1) A manufacturer may, by a written mandate, appoint an

authorised representative.

(2) The obligations laid down in regulation 8(1) and the

drawing up of technical documentation shall not form part of the

authorised representative’s mandate.

(3) An authorised representative shall perform the tasks

specified in the mandate received from the manufacturer. The

mandate shall allow the authorised representative to do at least the

following

(a) keep a copy of the declaration, as referred to in

regulation 16, and the technical documentation at the

disposal of national surveillance authorities for ten

years after the product has been placed on the market;

(b) further to a reasoned request from a competent

national authority, provide that authority with all the

information and documentation necessary to

demonstrate the conformity of a product;

(c) cooperate with the competent national authorities, at

their request, on any action taken to eliminate the risks

posed by products covered by their mandate.

(1)

Importers shall place only compliant

products on the market.

(2) Before placing a product on the market, importers shall

ensure that the appropriate conformity assessment procedure has

been carried out by the manufacturer. They shall ensure that the

manufacturer has drawn up the technical documentation, that the

product bears the CE marking, as referred to in regulation 17, and

is accompanied by the documents required in accordance with

regulation 16 and point 2.5 of Part A of Schedule I, point 4 of Part

B of Schedule I and point 2 of Part C of Schedule I and that the

manufacturer has complied with the requirements set out in

regulation 8(5) and (6).

Where an importer considers or has reason to believe that a

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product is not in conformity with the requirements set out in

regulation 5(1), he shall not place the product on the market until it

has been brought into conformity. Furthermore, where the product

presents a risk, the importer shall inform the manufacturer and the

market surveillance authorities to that effect.

(3) Importers shall indicate their name, registered trade name

or registered trade mark and the address at which they can be

contacted on the product or, in the case of components where that is

not possible, on the packaging or in a document accompanying the

product.

(4) Importers shall ensure that the product is accompanied by

instructions and safety information in the owner’s manual in at

least the English or Maltese language.

(5) Importers shall ensure that, while a product is under their

responsibility, storage or transport conditions do not jeopardise its

compliance with the requirements set out in regulation 5(1) and in

Schedule I.

(6) When deemed appropriate with regard to the risks presented

by a product, importers shall, to protect the health and safety of

consumers, carry out sample testing of products made available on

the market, investigate, and, if necessary, keep a register of

complaints, of non-conforming products and product recalls, and

shall keep distributors informed of such monitoring.

(7) Importers who consider or have reason to believe that a

product which they have placed on the market is not in conformity

with these regulations shall immediately take the corrective

measures necessary to bring that product into conformity, to

withdraw it or recall it, if appropriate. Furthermore, where the

product presents a risk, importers shall immediately inform the

competent national authorities of the Member States in which they

made the product available to that effect, giving details, in

particular, of the non-compliance and of any corrective measures

taken. The competent authority in the case of products imported

into Malta, shall be the Technical Regulations Division.

(8) Importers shall, for a period of ten years after the product

has been placed on the market, keep a copy of the declaration, as

referred to in regulation 16, at the disposal of the market

surveillance authorities and ensure that the technical

documentation can be made available to those authorities, upon

request.

(9) Importers shall, further to a reasoned request from the

Technical Regulations Division, provide it with all the information

and documentation necessary to demonstrate the conformity of a

product in at least the Maltese or the English language. They shall

cooperate with that authority, at its request, on any action taken to

eliminate the risks posed by products which they have placed on

the market.

(1) When making a product available on the market

distributors shall act with due care in relation to the requirements

of these regulations.

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(2) Before making a product available on the market

distributors shall verify that the product bears the CE marking, as

referred to in regulation 17, that it is accompanied by the

documents required in regulation 8(7), regulation 16 and point 2.5

of Part A of Schedule I, point 4 of Part B of Schedule I and point 2

of Part C of Schedule I and by instructions and safety information

in at least the English or Maltese language, and that the

manufacturer and the importer have complied with the

requirements set out in regulation 8(5) and (6) and in regulation

10(3).

Where a distributor considers or has reason to believe that a

product is not in conformity with the requirements set out in

regulation 5(1) and Schedule I, he shall not make the product

available on the market until it has been brought into conformity.

Furthermore, where the product presents a risk, the distributor shall

inform the manufacturer or the importer, as well as the market

surveillance authorities, to that effect.

(3) Distributors shall ensure that, while a product is under their

responsibility, storage or transport conditions do not jeopardise its

compliance with the requirements set out in regulation 5(1) and

Schedule I.

(4) Distributors who consider or have reason to believe that a

product which they have made available on the market is not in

conformity with these regulations shall make sure that the

corrective measures necessary to bring that product into

conformity, to withdraw it or recall it, if appropriate, are taken.

Furthermore, where the product presents a risk, distributors shall

immediately inform the competent national authorities of the

Member States in which they made the product available on the

market to that effect, giving details, in particular, of the non-

compliance and of any corrective measures taken.

(5) Distributors shall, further to a reasoned request from the

Technical Regulations Division, provide that authority with all the

information and documentation necessary to demonstrate the

conformity of the product. They shall cooperate with that authority,

at its request, on any action taken to eliminate the risks posed by

products which they have made available on the market.

An importer or distributor shall be considered a

manufacturer for the purposes of these regulations and he shall be

subject to the obligations of the manufacturer under regulation 8,

where he places a product on the market under his name or

trademark or modifies a product already placed on the market in

such a way that compliance with the requirements of these

regulations may be affected.

(1) If the manufacturer does not fulfil the responsibilities

for the conformity of the product with these regulations, a private

importer, before putting the product into service, shall ensure that it

has been designed and manufactured in accordance with the

requirements set out in regulation 5(1) and Schedule I and carry out

or have carried out the obligations of the manufacturer set out in

regulation 8(2), (3), (7) and (9).

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(2) If the required technical documentation is not available

from the manufacturer, the private importer shall have it drawn up

using appropriate expertise.

(3) The private importer shall ensure that the name and address

of the notified body which has carried out the conformity

assessment of the product is marked on the product.

(1) Economic operators shall, on request, identify the

following to the Technical Regulations Division

(a) any economic operator who has supplied them with a

product;

(b) any economic operator to whom they have supplied a

product.

(2) Economic operators shall be able to present the information

referred to in sub-regulation (1) for a period of ten years after they

have been supplied with the product and for a period of ten years

after they have supplied the product.

(3) Private importers shall, on request, identify to the

Technical Regulations Division the economic operator who has

supplied them with the product.

(4) Private importers shall be able to present the information

referred to in sub-regulation (3) for a period of ten years after they

have been supplied with the product.

Products which are in conformity with harmonised

standards or parts thereof the references of which have been

published in the Official Journal of the European Union shall be

presumed to be in conformity with the requirements covered by

those standards or parts thereof, set out in regulation 5(1) and

Schedule I.

(1) The EU declaration of conformity shall state that the

fulfilment of requirements specified in regulation 5(1) and

Schedule I or those referred to in regulation 7(4)(b) or (c) has been

demonstrated.

(2) The EU declaration of conformity, that shall have the model

structure set out in Schedule IV, shall contain the elements

specified in the relevant modules set out in Annex II to Decision

N o 7 6 8 / 2 0 0 8 / E C a s w e l l a s i n S c h e d u l e V, a n d s h a l l b e

continuously updated. It shall be translated into the language or

languages required by the Member State on whose market the

product is made available or put into service. For products made

available or put into service in the Maltese market, the EU

Declaration of Conformity shall be translated into at least the

Maltese or the English language.

(3) By drawing up the EU declaration of conformity, the

manufacturer, private importer or the person adapting the engine

referred to in regulation 7(4)(b) and (c) shall assume responsibility

for the compliance of the product.

(4) The EU declaration of conformity referred to in sub-

regulation (3) shall accompany the following products when they

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are made available on the market or put into service

(a) watercraft;

(b) components when placed on the market separately;

(c) propulsion engines.

(5) The declaration by the manufacturer or the importer set out

in Schedule III for partly completed watercraft shall contain the

elements specified in that Schedule and shall accompany partly

completed watercraft. It shall be translated into the language or

languages required by the Member State on whose market the

product is made available. For such products that are made

available on the Maltese market, this declaration shall be translated

into at least the Maltese or the English language.

(1) The CE marking shall be subject to the general

principles set out in Article 30 of Regulation (EC) No 765/2008.

(2) The following products are subject to CE marking when

they are made available on the market or put into service

(a) watercraft;

(b) components;

(c) propulsion engines.

(3) Products referred to in sub-regulation (2) and bearing the

CE marking shall be presumed to comply with these regulations.

(4) The CE marking shall be affixed visibly, legibly and

indelibly to the products referred to in sub-regulation (2). In case of

components, where that is not possible or not warranted on account

of the size or nature of that product, it shall be affixed to the

packaging and to the accompanying documents. In the case of

watercraft, the CE marking shall be affixed on the watercraft

b u i l d e r ’s p l a t e m o u n t e d s e p a r a t e l y f r o m t h e w a t e r c r a f t

identification number. In the case of a propulsion engine, the CE

marking shall be affixed on the engine.

(5) The CE marking shall be affixed before the product is

placed on the market or put into service. The CE marking, and the

identification number referred to in sub-regulation (6), may be

followed by a pictogram or any other mark indicating a special risk

or use.

(6) The CE marking shall be followed by the identification

number of the notified body, where that body is involved in the

production control phase or in the post-construction assessment.

(7) The identification number of the notified body shall be

affixed by the body itself or, under its instructions, by the

manufacturer or his authorised representative, or by the person

referred to in regulation 18(2), (3) or (4).

(1) The manufacturer shall apply the procedures set out in

the modules referred to in regulations 19, 20 and 21 before placing

on the market products referred to in regulation 3(1).

(2)

The private importer shall apply the procedure referred to

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in regulation 22 before putting into service a product referred to in

regulation 3(1) if the manufacturer has not carried out the

conformity assessment for the product concerned.

(3) Any person placing on the market or putting into service a

propulsion engine or a watercraft after a major modification or

conversion thereof, or any person changing the intended purpose of

a watercraft not covered by these regulations in a way that it falls

under its scope, shall apply the procedure referred to in regulation

22 before placing the product on the market or putting it into

service.

(4) Any person placing on the market a watercraft built for own

use before the end of the five-year period referred to in regulation

3(2)(a)(vii) shall apply the procedure referred to in regulation 22

before placing the product on the market.

(1) With regard to design and construction of recreational

craft the following procedures set out in Annex II to Decision No

768/2008/EC shall apply

(a) for design categories A and B referred to in point 1 of

Part A of Schedule I

(i) for recreational craft of hull length from 2,5m to

less than 12m, any of the following modules

• Module A1 (internal production control plus

supervised product testing);

• Module B (EU type-examination) together

with Module C, D, E or F;

• Module G (conformity based on unit

verification);

• Module H (conformity based on full quality

assurance);

(ii) for recreational craft of hull length from 12m to

24m, any of the following modules

• Module B (EU type-examination) together

with Module C, D, E or F;

• Module G (conformity based on unit

verification);

• Module H (conformity based on full quality

assurance);

(b) for design category C referred to in point 1 of Part A

of Schedule I

(i) for recreational craft of hull length from 2,5m to

less than 12m, any of the following modules

• where the harmonised standards relating to

points 3.2 and 3.3 of Part A of Schedule I are

complied with: Module A (internal

production control), Module A1 (internal

production control plus supervised product

testing), Module B (EU type-examination)

together with Module C, D, E or F, Module G

(conformity based on unit verification) or

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Module H (conformity based on full quality

assurance);

• where the harmonised standards relating to

points 3.2 and 3.3 of Part A of Schedule I are

not complied with: Module A1 (internal

production control plus supervised product

testing), Module B (EU type-examination)

together with Module C, D, E or F, Module G

(conformity based on unit verification) or

Module H (conformity based on full quality

assurance);

(ii) for recreational craft of hull length from 12m to

24m, any of the following modules

• Module B (EU type-examination) together

with Module C, D, E or F;

• Module G (conformity based on unit

verification);

• Module H (conformity based on full quality

assurance);

(c) for design category D referred to in point 1 of Part A

of Schedule I

for recreational craft of hull length from 2,5m to

24m, any of the following modules

• Module A (internal production control);

• Module A1 (internal production control plus

supervised product testing);

• Module B (EU type-examination) together

with Module C, D, E or F;

• Module G (conformity based on unit

verification);

• Module H (conformity based on full quality

assurance).

(2) With regard to design and construction of personal

watercraft any of the following procedures set out in Annex II to

Decision No 768/2008/EC shall apply

(a) Module A (internal production control);

(b) Module A1 (internal production control plus

supervised product testing);

(c) Module B (EU type-examination) together with

Module C, D, E or F;

(d) Module G (conformity based on unit verification);

(e) Module H (conformity based on full quality

assurance).

(3) With regard to design and construction of components any

of the following procedures set out in Annex II to Decision No 768/

2008/EC shall apply

(a) Module B (EU type-examination) together with

Module C, D, E or F;

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(b) Module G (conformity based on unit verification);

(c) Module H (conformity based on full quality

assurance).

With regard to exhaust emissions, for products referred to

in regulation 3(1)(d) and (e), the engine manufacturer shall apply

the following procedures set out in Annex II to Decision No 768/

2008/EC

(a) where tests are conducted using the harmonised

standard, any of the following modules

(i) Module B (the EU type-examination) together

with Module C, D, E or F;

(ii) Module G (conformity based on unit

verification);

(iii) Module H (conformity based on full quality

assurance);

(b) where tests are conducted without using the

harmonised standard, any of the following modules

(i) Module B (the EU type-examination) together

with Module C 1;

(ii) Module G (conformity based on unit

verification).

(1) With regard to noise emissions for recreational craft

with stern drive propulsion engines without integral exhausts or

inboard propulsion engine installations and for recreational craft

with stern drive propulsion engines without integral exhausts or

with inboard propulsion engine installations which are subject to

major craft conversion and subsequently placed on the market

within five years following conversion, the manufacturer shall

apply the following procedures set out in Annex II to Decision No

768/2008/EC

(a) where tests are conducted using the harmonised

standard for noise measurement, any of the following

modules

(i) Module A1 (internal production control plus

supervised product testing);

(ii) Module G (conformity based on unit

verification);

(iii) Module H (conformity based on full quality

assurance);

(b) where tests are conducted without using the

harmonised standard for noise measurement, Module

G (conformity based on unit verification);

(c) where the Froude number and power displacement

ratio method is used for assessment, any of the

following modules

(i) Module A (internal production control);

(ii) Module G (conformity based on unit

verification);

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(iii) Module H (conformity based on full quality

assurance).

(2) With regard to noise emissions for personal watercraft and

outboard propulsion engines and stern drive propulsion engines

with integral exhausts intended for installation on recreational

craft, the personal watercraft or engine manufacturer shall apply

the following procedures set out in Annex II to Decision No 768/

2008/EC

(a) where tests are conducted using the harmonised

standard for noise measurement, any of the following

modules

(i) Module A1 (internal production control plus

supervised product testing);

(ii) Module G (conformity based on unit

verification);

(iii) Module H (conformity based on full quality

assurance);

(b) where tests are conducted without using the

harmonised standard for noise measurement, Module

G (conformity based on unit verification).

The post-construction assessment referred to in regulation

18(2), (3) and (4) shall be carried out as set out in Schedule V.

(1) When Module B of Annex II to Decision No 768/2008/

EC is used, the EU type examination shall be carried out in the

manner specified in the second indent of point 2 of that module.

A production type referred to in Module B may cover

several versions of the product provided that

(a) the differences between the versions do not affect the

level of safety and the other requirements concerning

the performance of the product; and

(b) versions of the product are referred to in the

corresponding EU-type examination certificate, if

necessary through amendments to the original

certificate.

(2) When Module A1 of Annex II to Decision No 768/2008/EC

is used, the product checks shall be carried out on one or several

watercraft representing the production of the manufacturer and the

supplementary requirements set out in Schedule VI shall apply.

(3) The possibility of using accredited in-house bodies referred

to in Modules A1 and C1 of Annex II to Decision No 768/2008/EC

shall not be applicable.

(4) When Module F of Annex II to Decision No 768/2008/EC

is used, the procedure described in Schedule VII shall apply for the

assessment of conformity with the exhaust emission requirements.

(5) When Module C of Annex II to Decision No 768/2008/EC

is used, with regard to the assessment of conformity with the

exhaust emission requirements of these regulations and if the

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manufacturer is not working under a relevant quality system as

described in Module H of Annex II to Decision No 768/2008/EC, a

notified body chosen by the manufacturer shall carry out product

checks or have them carried out at random intervals determined by

that body, in order to verify the quality of the internal checks on the

product. When the quality level appears unsatisfactory or when it

seems necessary to verify the validity of the data presented by the

manufacturer, the procedure set out in Schedule VIII shall apply.

(1) The technical documentation referred to in regulation

8(2) shall contain all relevant data and details of the means used by

the manufacturer to ensure that the product complies with the

requirements set out in regulation 5(1) and Schedule I. It shall, in

particular, contain the relevant documents listed in Schedule IX.

(2) The technical documentation shall ensure that the design,

construction, operation and assessment of conformity may be

clearly understood.

(1) The Technical Regulations Division shall notify the

European Commission and the other Member States of bodies

authorised to carry out third-party conformity assessment under

these regulations.

(2) The Technical Regulations Division shall be responsible for

setting up and carrying out the necessary procedures for the

assessment and notification of conformity assessment bodies for

the purposes of these regulations, and for the monitoring of notified

bodies, including compliance with the provisions of regulation

26(13) to (16).

(3) The assessment and monitoring referred to in sub-

regulation (2) shall be carried out by the National Accreditation

Board (Malta).

(4) The Technical Regulations Division shall take full

responsibility for the tasks performed by National Accreditation

Board (Malta) referred to in sub-regulation (3).

(4) The Technical Regulations Division shall inform the

European Commission of its procedures for the assessment and

notification of conformity assessment bodies and the monitoring of

notified bodies, and of any changes thereto.

(1) For the purposes of notification under these

regulations, a conformity assessment body shall meet the

requirements laid down in sub-regulations (2) to (16) and in the

Method for Designating Conformity Assessment Bodies

Regulations.

(2) A conformity assessment body shall be established under

Maltese law of and have legal personality.

(3) A conformity assessment body shall be a third-party body

independent of the organisation or the product it assesses. A body

belonging to a business association or professional federation

representing undertakings involved in the design, manufacturing,

provision, assembly, use or maintenance of products which it

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assesses, may, on condition that its independence and the absence

of any conflict of interest are demonstrated, be considered such a

(4)

(a) A conformity assessment body, its top level

management and the personnel responsible for carrying

out the conformity assessment tasks shall not be the

designer, manufacturer, supplier, installer, purchaser,

owner, user or maintainer of the products which they

assess, nor the representative of any of those parties.

This shall not preclude the use of assessed products

that are necessary for the operations of the conformity

assessment body or the use of such products for

personal purposes.

(b) A conformity assessment body, its top level

management and the personnel responsible for

carrying out the conformity assessment tasks shall not

be directly involved in the design or manufacture, the

marketing, installation, use or maintenance of those

products, or represent the parties engaged in those

activities. They shall not engage in any activity that

may conflict with their independence of judgement or

integrity in relation to conformity assessment

activities for which they are notified. This shall in

particular apply to consultancy services.

(c) Conformity assessment bodies shall ensure that the

activities of their subsidiaries or subcontractors do not

affect the confidentiality, objectivity or impartiality of

their conformity assessment activities.

(5) Conformity assessment bodies and their personnel shall

carry out the conformity assessment activities with the highest

degree of professional integrity and the requisite technical

competence in the specific field and shall be free from all pressures

and inducements, particularly financial, which might influence

their judgement or the results of their conformity assessment

activities, especially as regards persons or groups of persons with

an interest in the results of those activities.

(6)

(a) A conformity assessment body shall be capable of

carrying out all the conformity assessment tasks

assigned to it by the provisions of regulations 18 to 23

and in relation to which it has been notified, whether

those tasks are carried out by the conformity

assessment body itself or on its behalf and under its

responsibility.

(b) At all times and for each conformity assessment

procedure and each kind or category of products in

relation to which it has been notified, a conformity

assessment body shall have at its disposal the

necessary

(i) personnel with technical knowledge and

sufficient and appropriate experience to perform

the conformity assessment tasks;

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(ii) descriptions of procedures in accordance with

which conformity assessment is carried out,

ensuring the transparency and the ability of

reproduction of those procedures. It shall have

appropriate policies and procedures in place that

distinguish between tasks it carries out as a

notified body and other activities;

(iii) procedures for the performance of activities

which take due account of the size of an

undertaking, the sector in which it operates, its

structure, the degree of complexity of the

product technology in question and the mass or

serial nature of the production process.

(c) A conformity assessment body shall have the means

necessary to perform the technical and administrative

tasks connected with the conformity assessment

activities in an appropriate manner and shall have

access to all necessary equipment or facilities.

(7) The personnel responsible for carrying out conformity

assessment tasks shall have the following

(a) sound technical and vocational training covering all

the conformity assessment activities in relation to

which the conformity assessment body has been

notified;

(b) satisfactory knowledge of the requirements of the

assessments they carry out and adequate authority to

carry out those assessments;

(c) appropriate knowledge and understanding of the

essential requirements, of the applicable harmonised

standards and of the relevant provisions of Union

harmonisation legislation and of the relevant national

legislation;

(d) the ability to draw up certificates, records and reports

demonstrating that assessments have been carried out.

(8) The impartiality of conformity assessment bodies, their top

level management and of the assessment personnel shall be

ensured. The remuneration of the top level management and

assessment personnel of a conformity assessment body shall not

depend on the number of assessments carried out or on the results

of those assessments.

(9) Conformity assessment bodies shall take out liability

insurance unless liability is assumed by the State in accordance

with national law, or the State itself is directly responsible for the

conformity assessment.

(10) The personnel of a conformity assessment body shall

observe professional secrecy with regard to all information

obtained in carrying out their tasks under regulations 18 to 23 or

any provision of national law giving effect to it, except in relation

to the competent authorities of the Member State in which its

activities are carried out. Proprietary rights shall be protected.

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(11) Conformity assessment bodies shall participate in, or

ensure that their personnel responsible for carrying out the

conformity assessment tasks are informed of, the relevant

standardisation activities and the activities of the notified body

coordination group established under Article 42 of the Directive

and shall apply as general guidance the administrative decisions

and documents produced as a result of the work of that group.

(12) Where a conformity assessment body demonstrates its

conformity with the criteria laid down in the relevant harmonised

standards or parts thereof, the references of which have been

published in the Official Journal of the European Union, it shall be

presumed to comply with the requirements set out in these

regulations insofar as the applicable harmonised standards cover

those requirements.

(13) Where a notified body subcontracts specific tasks

connected with conformity assessment or has recourse to a

subsidiary, it shall ensure that the subcontractor or the subsidiary

meets the requirements set out in these regulations, and shall

inform the Technical Regulations Division accordingly.

(14) Notified bodies shall take full responsibility for the tasks

performed by subcontractors or subsidiaries, wherever these are

established.

(15) Activities may be subcontracted or carried out by a

subsidiary only with the agreement of the client.

(16) Notified bodies shall keep at the disposal of the Technical

Regulations Division the relevant documents concerning the

assessment of the qualifications of the subcontractor or the

subsidiary and the work carried out by them under regulations 18 to

23.

(1) A conformity assessment body established in Malta

shall submit an application for notification under these regulations

to the Technical Regulations Division.

(2) The application referred to in sub-regulation (1) shall be

accompanied by a description of the conformity assessment

activities, the conformity assessment module or modules and the

product or products for which that body claims to be competent, as

well as by an accreditation certificate issued by the National

Accreditation Board (Malta) attesting that the conformity

assessment body fulfils the requirements laid down in regulation 26

and the Method for Designating Conformity Assessment Bodies

Regulations.

(3) The Technical Regulations Division may only notify

conformity assessment bodies which have satisfied the

requirements laid down in regulation 26 and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify conformity

assessment bodies to the European Commission and the other

Member States using the electronic notification tool developed and

managed by the Commission.

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(5) The notification shall include full details of the conformity

assessment activities, the conformity assessment module or

modules, product or products concerned and the relevant attestation

of competence.

(6) The body concerned may perform the activities of a notified

body only where no objections are raised by the European

Commission or the other Member States within two weeks of a

notification. Only such a body shall be considered a notified body

for the purposes of these regulations.

(7) The Technical Regulations Division shall notify the

European Commission and the other Member States of any

subsequent relevant changes to the notification.

(8) The Technical Regulations Division shall assign an

identification code to a notified body that it has authorised to

undertake the post-construction conformity assessments.

(9) Where the Technical Regulations Division has ascertained

or has been informed that a notified body no longer meets the

requirements laid down in regulation 26 or the Method for

Designating Conformity Assessment Bodies Regulations, or that it

is failing to fulfil its obligations, the Technical Regulations

Division shall restrict, suspend or withdraw notification as

appropriate, depending on the seriousness of the failure to meet

those requirements or fulfil those obligations. It shall immediately

inform the European Commission and the other Member States

accordingly.

(10) In the event of restriction, suspension or withdrawal of

notification, or where the notified body has ceased its activity, the

Technical Regulations Division shall take appropriate steps to

ensure that the files of that body are either processed by another

notified body or kept available to the responsible notifying and

market surveillance authorities, at their request.

(11) The Technical Regulations Division shall provide the

Commission, on request, with all information relating to the basis

for the notification or the maintenance of the competence of the

body concerned.

(1) Notified bodies shall carry out conformity assessments

in accordance with the conformity assessment procedures provided

for in regulations 18 to 23.

(2) Conformity assessments shall be carried out in a

proportionate manner, avoiding unnecessary burdens for economic

operators and private importers. Conformity assessment bodies

shall perform their activities taking due account of the size of an

undertaking, the sector in which it operates, its structure, the degree

of complexity of the product technology in question and the mass

or serial nature of the production process. In so doing, they shall

nevertheless respect the degree of rigour and the level of protection

required for the compliance of the product with these regulations.

(3) Where a notified body finds that requirements laid down in

regulation 5(1) and Schedule I or in corresponding harmonised

standards have not been met by a manufacturer or a private

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importer, it shall require that manufacturer or private importer to

take appropriate c orrective measures and shall not issue a

certificate of conformity.

(4) Where, in the course of the monitoring of conformity

following the issue of a certificate, a notified body finds that a

product is no longer in compliance; it shall require the

manufacturer to take appropriate corrective measures and shall

suspend or withdraw the certificate if necessary.

(5) Where corrective measures are not taken or do not have the

required effect, the notified body shall restrict, suspend or

withdraw any certificates, as appropriate.

(6) Notified bodies shall inform the Technical Regulations

Division of the following

(a) any refusal, restriction, suspension or withdrawal of a

certificate;

(b) any circumstances affecting the scope of or conditions

for notification;

(c) any request for information which they have received

from market surveillance authorities regarding

conformity assessment activities;

(d) on request, conformity assessment activities

performed within the scope of their notification and

any other activity performed, including cross-border

activities and subcontracting.

(7) Notified bodies shall provide the other bodies notified

under the Directive carrying out similar conformity assessment

activities covering the same products with relevant information on

issues relating to negative and, on request, positive conformity

assessment results.

(8) Notified bodies shall participate, directly or by means of

designated representatives, in the appropriate coordination and

cooperation groups for notified bodies organised by the European

Commission.

(1) The Technical Regulations Division shall take

appropriate measures to ensure that products referred to in

regulation 3(1) may be made available or put into service only if

they do not endanger the health and safety of persons, property or

the environment when correctly maintained and used in accordance

with their intended purpose, and only on the condition that they

meet the applicable essential requirements set out in Schedule I.

(2) Article 15(3) and Articles 16 to 29 of Regulation (EC) No

765/2008 shall apply to products covered by these regulations.

(3) Where the Technical Regulations Division has sufficient

reasons to believe that a product covered by these regulations

presents a risk to the health or safety of persons, to property or to

the environment, they shall carry out an evaluation in relation to

the product concerned covering all relevant requirements laid down

in these regulations. The relevant economic operators or the private

i m p o r t e r s h a l l c o o p e r a t e a s n e c e s s a r y w i t h t h e Te c h n i c a l

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Regulations Division.

(4)

(a) In the case of an economic operator, where, in the

course of that evaluation, the Technical Regulations

Division finds that the product does not comply with

the requirements laid down in these regulations, it shall

without delay require the relevant economic operator

to take the appropriate corrective action to bring the

product into compliance with those requirements, to

withdraw the product from the market, or to recall it

within a reasonable period, commensurate with the

nature of the risk, as it may prescribe. It shall also

inform the Notified Body accordingly.

(b) In the case of a private importer, where, in the course

of that evaluation, the Technical Regulations Division

finds that the product does not comply with the

requirements laid down in these regulations, the

private importer shall be informed without delay of the

appropriate corrective action to be taken to bring the

product into compliance with those requirements, to

suspend the putting into service of the product or to

suspend the use of the product, commensurate with the

nature of the risk. It shall also inform the Notified

Body accordingly.

(5) Article 21 of Regulation (EC) No 765/2008 shall apply to

the measures referred to in sub-regulation (4)(a) and (b).

(6) Where the Technical Regulations Division considers that

non-compliance is not restricted to the Maltese territory, it shall

inform the European Commission and the other Member States of

the results of the evaluation and of the actions which it has required

the economic operator to take.

(7)

(a) The economic operator shall ensure that all appropriate

corrective action is taken in respect of all the products

concerned that it has made available on the market

throughout the European Union.

(b) The private importer shall ensure that the appropriate

corrective action is taken in respect of the product that

he has imported in the European Union for his own

use.

(8)

(a) Where the relevant economic operator does not take

adequate corrective action within the period referred to

in sub-regulation (4)(a), the Technical Regulations

Division shall take all appropriate provisional

measures to prohibit or restrict the product being made

available on the Maltese market, to withdraw the

product from this market or to recall it.

(b) Where the private importer does not take adequate

corrective action, the Technical Regulations Division

shall take all appropriate provisional measures to

prohibit the putting into service of the product, or

prohibit or restrict the use of the product in the

Maltese territory.

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(9) The Technical Regulations Division shall inform the

European Commission and the other Member States, without delay,

of those measures referred to in sub-regulation (8).

(10) The information referred to in sub-regulation (9) shall

include all available details, in particular the data necessary for the

identification of the non-compliant product, the origin of the

product, the nature of the non-compliance alleged and the risk

involved, the nature and duration of the national measures taken

and the arguments put forward by the relevant economic operator

or the private importer. In particular, the Technical Regulations

Division shall indicate whether the non-compliance is due to either

of the following

(a) failure of the product to meet requirements relating to

the health or safety of persons, the protection of

property or the environment laid down in these

regulations; or

(b) shortcomings in the harmonised standards referred to

in regulation 15 conferring a presumption of

conformity.

(11) When the procedure under this regulation is initiated by

another Member State, the Technical Regulations Division shall

without delay inform the European Commission and the other

Member States of any measures adopted and of any additional

information at their disposal relating to the non-compliance of the

product concerned, and, in the event of disagreement with the

adopted national measure, of their objections.

(12) Where, within three months of receipt of the information

referred to in sub-regulation (9), no objection has been raised by

either a Member State or the European Commission in respect of a

provisional measure taken by a Member State, that measure shall

be deemed justified.

In such cases, the Technical Regulations Division shall

ensure that appropriate restrictive measures are taken in respect of

the product concerned, such as withdrawal of the product from the

Maltese market, without delay.

(13) Where on completion of the procedure set out in sub-

regulations (7) to (9), objections are raised against a measure taken

by Technical Regulations Division, or where the European

Commission considers a national measure to be contrary to

European Union legislation, the European Commission shall

without delay enter into consultation with the Member States and

the relevant economic operator or operators or the private importer

and shall evaluate the national measure. On the basis of the results

of that evaluation, the Commission shall adopt an implementing act

determining whether the national measure is justified or not.

If, on the basis of this evaluation, the national measure is

considered justified, the Technical Regulations Division shall

ensure that the non-compliant product is withdrawn from the

Maltese market and shall inform the European Commission

accordingly.

RECREATIONAL CRAFT

If, on the basis of this evaluation, the national measure is

considered unjustified, the national measure shall be withdrawn.

(14) Without prejudice to sub-regulations (3) to (13), where the

Technical Regulations Division make one of the following

findings, it shall require the relevant economic operator or the

private importer to put an end to the non-compliance concerned

(a) the CE marking has been affixed in violation of

regulation 17;

(b) the CE marking has not been affixed;

(c) the EU declaration of conformity or the declaration

referred to in Schedule III has not been drawn up;

(d) the EU declaration of conformity or the declaration

referred to in Schedule III has not been drawn up

correctly;

(e) the technical documentation is either not available or

not complete;

(f) the information referred to in regulation 8(6) or

regulation 10(3) is absent, false or incomplete;

(g) any other administrative requirement provided for in

regulation 8 or regulation 10 is not fulfilled.

(15) Where the non-compliance referred to in sub-regulation

(14) persists, the Technical Regulations Division shall take all

appropriate measures to restrict or prohibit the product being made

available on the Maltese market or ensure that it is recalled or

withdrawn from the Maltese market, or in the case of a product

imported by a private importer for his own use, that its use is

prohibited or restricted.

The Authority for Transport in Malta shall be the

designated competent authority in Malta responsible for assigning

the unique code of the manufacturer referred to in point 2.1 of Part

A of Schedule I.

The penalties applicable for the infringement of any of the

provisions of these regulations shall be those provided for in Part

IV of the Product Safety Act.

(Omitted under the Statute Law Revision Act, 1980).

(1) Any references to the Recreational Craft Regulations,

2005 * , hereinafter referred to as "the revoked regulations" shall be

construed as references to these regulations.

(2) Any references in existing laws, regulations and

administrative provisions to Directive 94/25/EC shall be construed

as references to Directive 2013/53/EU.

*Revoked by these Regulations.

RECREATIONAL CRAFT