directive that
apply to them. The manufacturer or his authorised representative established
within the Community must affix the CE mark to each product and draw up a
written declaration of conformity.

The CE mark must be accompanied by the identification symbol of the
notified body responsible for surveillance as specified in point 4.

2. The manufacturer must operate an approved quality system for final
product inspection and testing as specified in point 3 and must be subject to
surveillance as specified in point 4.

3. Quality system

3.1. The manufacturer must lodge an application for assessment of his
quality system for the products concerned, with a notified body of his choice.

The application must include:

— all relevant information for the product category envisaged,

— the quality system's documentation,

— if applicable, the technical documentation of the approved type and a
copy of the EC typeexamination certificate.

3.2. Under the quality system, each product must be examined and
appropriate tests as set out in the relevant standard(s) referred to in Article
5 or equivalent tests shall be carried out in order to ensure its conformity
with the relevant requirements of the directive. All the elements, requirements
and provisions adopted by the manufacturer must be documented in a systematic
and orderly manner in the form of written policies, procedures and
instructions. This quality system documentation must ensure a common
understanding of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

— the quality objectives and the organisational structure,
responsibilities and powers of the management with regard to product quality,

— the examinations and tests that will be carried out after manufacture,

— the means to monitor the effective operation of the quality system,

— quality records, such as inspection reports and test data, calibration
data, qualification reports of the personnel concerned, etc.

3.3. The notified body must assess the quality system to determine
whether it satisfies the requirements

referred to in point 3.2.

It presumes conformity with these requirements in respect of quality
systems that implement the relevant harmonised standard.

The auditing team must have at least one member experienced as an
assessor in the product technology concerned. The assessment procedure must
include an assessment visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must
contain the conclusions of the examination and the reasoned assessment
decision.

3.4. The manufacturer must undertake to fulfil the obligations arising
from the quality system as approved and to maintain it in an appropriate and
efficient manner.

The manufacturer or his authorised representative must keep the notified
body which has approved the quality system informed of any intended updating of
the quality system.

The notified body must evaluate the modifications proposed and decide
whether the modified quality system will still satisfy the requirements
referred to in point 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must
contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body

4.1. The purpose of surveillance is to make sure that the manufacturer
duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer must allow the notified body entrance for
inspection purposes to the locations of inspection, testing and storage and
shall provide it with all necessary information, in particular:

— the quality system documentation,

— the technical documentation,

— the quality records, such as inspection reports and test data,
calibration data, qualification reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out audits to ensure that
the manufacturer maintains and applies the quality system and must provide an
audit report to the manufacturer.

4.4. Additionally, the notified body may pay unexpected visits to the
manufacturer. At the time of such visits, the notified body may carry out tests
or have them carried out in order to check the proper functioning of the
quality system where necessary; it must provide the manufacturer with a visit
report and, if a test has been carried out, with a test report.

5. The manufacturer must, for a period ending at least 10 years after
the last product has been manufactured, keep at the disposal of the national
authorities:

— the documentation referred to in the third indent of the second
subparagraph of point 3.1,

— the updating referred to in the second subparagraph of point 3.4,

— the decisions and reports from the notified body which are referred to
in the final subparagraph of point 3.4, points 4.3 and 4.4.

6. Each notified body must forward to the other notified bodies the
relevant information concerning the quality system approvals issued and
withdrawn.

ANNEX XVII

CONFORMITY OF PRODUCTION ASSESSMENT FOR EXHAUST AND NOISE EMISSIONS

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



X = the arithmetical mean of the results

x = the individual results of the sample

L = the appropriate limit value

n = the number of engines in the sample

k = statistical factor depending on n (see table)




n


2


3


4


5


6


7


8


9


10




k


0,973


0,613


0,489


0,421


0,376


0,342


0,317


0,296


0,279




n


11


12


13


14


15


16


17


18


19




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/√n. k =0,860 /√n’.

Article 2

By 31 December 2006 the Commission shall submit a report on the
possibilities of further improving the environmental characteristics of engines
and consider inter alia the need to revise the boat design categories. If deemed appropriate, in
the light of this report, the Commission shall by 31 December 2007 submit
appropriate proposals to the European Parliament and the Council. The
Commission shall in the light of the experience gained take account of:

(a) the need to further reduce emissions of air pollutants and noise in
order to meet environment protection requirements;

(b) the possible benefits of a system for ‘in-use compliance’;

(c) the availability of cost efficient techniques for controlling
emissions;

(d) the need to reduce evaporation and spill of fuel;

(e) the possibility of agreeing on international standards for exhaust
and noise emissions;

(f) possible simplifications of the system for conformity assessment
procedures.

Article 3

1. Member States shall adopt and publish the laws, regulations and
administrative provisions necessary to comply with the requirements of this
Directive by 30 June 2004. They shall immediately inform the Commission
thereof.

Member States shall apply such measures as from 1 January 2005.

2. Member States shall permit the placing on the market and/or putting
into service of products which comply with the rules in force in their
territory on the date of entry into force of this Directive, as follows:

(a) until 31 December 2005 for the products falling under Article
1(1)(a);

(b) until 31 December 2005 for compression ignition and four-stroke
spark ignition engines; and,

(c) until 31 December 2006 for two-stroke spark ignition engines.

3. When Member States adopt the measures referred to in paragraph 1,
they shall contain a reference to this Directive or shall be accompanied by
such reference on the occasion of their official publication. The methods of
making such reference shall be laid down by Member States.

4. Member States shall communicate to the Commission the text of the
provisions of national law which they adopt in the field governed by this
Directive.

Article 4

Member States shall determine the penalties applicable to breaches of
the national provisions adopted pursuant to this Directive. The penalties shall
be effective, proportionate and dissuasive.

Article 5

This Directive shall enter into forc