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QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

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Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

SUBSIDIARY LEGISLATION 549.23

QUALITY REQUIRED OF SHELLFISH WATERS

REGULATIONS

1st March, 2002

LEGAL NOTICE 341 of 2001, as amended by Legal Notice 426 of 2007.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The title of these regulations is the Quality required of

Shellfish Waters Regulations.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1) These regulations concern the quality of shellfish

waters and apply to the coastal and brackish waters designated by

the competent authority as needing protection or improvement in

order to support shellfish (bivalve and gastropod molluscs) life and

growth and thus to contribute to the high quality of shellfish

products directly edible by man.

(2) The parameters applicable to the waters designated by the

competent authority are listed in Annex I.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1) The competent authority shall for the designated

waters, set values for the parameters listed in Annex I, in so far as

values are given in column G or column I. The competent authority

shall comply with the comments contained in both columns.

(2) The competent authority shall not set values less stringent

than those given in column I of Annex I and shall endeavour to

observe the values in column G, while taking into account the

principle set out in regulation 8.

(3) For discharges of effluents falling within parameters

"organohalogenated substances" and "metals", the emission

standards laid down by the competent authority pursuant to the

Pollution Caused by Certain Dangerous Substances Discharged into

the Aquatic Environment Regulations shall be applied at the same

time as the quality objectives and the other obligations arising from

these regulations, in particular those relating to sampling.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1)

The competent authority shall designate shellfish

waters.

(2) The competent authority may subsequently make additional

designations.

(3) The competent authority may revise the designation of

certain waters owing in particular to factors unforeseen at the time

of desi gnation, t akin g into acco unt the principl e set out in

regulation 8.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The competent authority shall establish programmes in

order to reduce pollution and to ensure that designated waters

conform, within six years following designation in accordance with

regulation 4, to both the values set by the competent authority in

accordance with regulation 3 and the comments contained in

columns G and I of Annex I.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1) For the purpose of implementing regulation 5, the

designated waters shall be deemed to conform to the provisions of

these regulations if samples of such waters, taken at the minimum

frequency specified in Annex I, at the same sampling point and

over a period of twelve months, show that they conform to both the

values set by the competent authority in accordance with regulation

3 and the comments contained in columns G and I of Annex I as

regards

-

100% of the samples for the parameters

"organohalogenated substances" and "metals"

-

95% of the samples for the parameters "salinity" and

"dissolved oxygen"

-

75% of the samples for the other parameters listed in

Annex I.

If, in accordance with subregulation (2), the sampling

frequency for all the parameters in Annex I except "organo-

halogenated substances" and "metals" is lower than that indicated

in Annex I, the above mentioned values and comments shall be

complied with in the case of all the samples.

(2) Instances in which the values set by the competent authority

in accordance with regulation 3 or the comments contained in

columns G and I of Annex I are not respected shall not be taken

into consideration in the calculation of the percentages provided for

in subregulation (1) when it is the result of a disaster or an

emergency.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1) The competent authority shall carry out sampling

operations, the minimum frequency of which is laid down in Annex

I.

(2) Where the competent authority records that the quality of

designated waters is appreciably higher than that which would

result from the application of the values set in accordance with

regulation 3 and the comments contained in Columns G and I of

Annex I, the frequency of the sampling may be reduced. Where

there is no pollution and no risk of deterioration in the quality of

the waters, the competent authority may decide that no sampling is

necessary.

(3) If sampling shows that a value set in accordance with

regulation 3 or a comment contained in columns G and I of Annex I

is not respected, the competent authority shall establish whether

this is the result of chance, a natural phenomenon or pollution, and

shall adopt appropriate measures.

(4) The exact sampling point, the distance from this point to

the nearest point where pollutants are discharged and the depth at

which the samples are to be taken shall be fixed by the competent

authority on the basis of local environmental conditions in

particular.

(5) The reference methods of analysis to be used for calculating

the value of the parameters concerned are set out in Annex I.

Laboratories that employ other methods shall ensure that the results

obtained are equivalent or comparable to those specified in Annex

I.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

Implementation of the measures taken pursuant to these

regulations may on no account lead, either directly or indirectly, to

increased pollution of coastal and brackish waters.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The competent authority may at any time set more

stringent values for the designated waters than those laid down in

these regulations. The competent authority may also lay down

provisions relating to other parameters than those provided for in

these regulations.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The competent authority may derogate from these

regulations in the event of exceptional weather or geographical

condition

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

Such amendments as are necessary for adapting to

technical and scientific progress the G values for the parameters

and the methods of analysis contained in Annex I shall be adopted

by the competent authority.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The competent authority shall publish by notice in the

Gazette on a periodic basis information concerning

-

the waters designated in accordance with regulation

4(1) and (2) in summary form,

-

the revision of the designation of certain waters in

accordance with regulation 4(3),

-

the provisions laid down in order to establish new

parameters in accordance with regulation 9.

Where the competent authority applies the provisions of

regulation 11, it shall forthwith publish by notice in the Gazette

reasons and the periods anticipated.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

Any person shall be guilty of an offence under these

offences under these regulations if

(a) he fails to comply with any provision of these

regulations or with any order lawfully given in terms

of any provision of these regulations; or

(b) he contravenes any restriction, prohibition or

requirement imposed by or under these regulations; or

(c) he acts in contravention of any of the provisions of

these regulations; or

(d) he conspires or attempts, or aids, or abets, any other

person by whatever means, including advertising,

counselling or procurement to contravene the

provisions of these regulations or to fail to comply

with any such provisions, including any order lawfully

given in terms of any of the provisions of these

regulations, or to contravene any restriction,

prohibition or requirement imposed by or under the

said regulations.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

Any person who commits an offence against these

regulations shall, on conviction, be liable

(a) on a first conviction to a fine (multa) of not less than

twenty-three thousand and two hundred and ninety-

three euro and seventy-three cents (€23,293.73) but

not exceeding two hundred and thirty-two thousand

and nine hundred and thirty-seven euro and thirty-four

cents (€232,937.34);

(b) on a second or subsequent convictions, to a fine

(multa) of not less than one hundred and sixteen

thousand and four hundred and sixty-eight euro and

sixty-seven cents (€116,468.67), but not exceeding

four hundred and sixty-five thousand and eight

hundred and seventy-four euro and sixty-eight cents

(€465,874.68) or to imprisonment for a term not

exceeding two years, or to both such fine and

imprisonment

Provided that whenever any person is found guilty of

committing an offence under these regulations by means of a

vehicle or ship, the owner of the said vehicle or ship, where

applicable, is held liable in the same manner and degree

Provided further that the court shall order any person who

has been found guilty of committing an offence against these

regulations to pay for the expenses incurred by the competent

authority or any public entity or any other persons acting on their

behalf involved in the implementation of these regulations, and

restitution of the environment as a result of the said offence, and

the confiscation of the corpus delicti.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

(1) The provisions of articles 23 and 30(1) of the Criminal

Code shall, mutatis mutandis, apply to proceedings, in respect of

offences against these regulations, so however that the

disqualification from holding or obtain a licence, permit or

authority shall in no case be for less than one year.

(2) Notwithstanding the provisions of article 370 of the

Criminal Code, proceedings for an offence against these

regulations shall be taken before the Court of Magistrates (Malta)

or the Court of Magistrates (Gozo), as the case may be, and shall be

in accordance with the provisions of the Criminal Code regulating

the procedure before the said courts as courts of criminal

judicature.

(3) Notwithstanding the provisions of the Criminal Code, the

Attorney General shall always have a right of appeal to the Court of

Criminal Appeal from any judgement given by the Court of

Magistrates (Malta) or the Court of Magistrates (Gozo) in respect

of proceedings for any offence against these regulations.

Laws of Malta — Subsidiary Legislation 549.23 — QUALITY REQUIRED OF SHELLFISH WATERS REGULATIONS

The Annexes to these regulations are being published in

the English language with the English text of these regulations.

ANNEX 1

QUALITY OF SHELLFISH WATERS

Minimum

Reference

sampling and

Parameter

G

I

methods of

measuring

analysis

frequency

- Electrometry

1. pH

7 - 9

Quarterly

pH unit

Measured

in

situ at the time

of sampling

2. Temperature ºC A

discharge

- Thermometry

Quarterly

affecting

Measured

in

shellfish waters

at

the

time

situ

must not cause

of sampling

t he t em pe ra tu r e

of the waters to

ex cee d by m or e

than 2ºC the

temperature of

waters not so

affected

3. Coloration

A

d i s c h a r g e - Filter through a Quarterly

(after filtration)

affecting shellfish 0 · 4 5

µm

mg Pt/l

wa te rs must not membrane

cause the colour

of the waters after Photometric

t o m e t h o d , us i n g

filtration

deviate by more t h e p l a t i n u m /

t h a n 1 0 m g P t / l cobalt scale

from the colour of

waters not so

affected

4. Suspended

A

d i s c h a r g e - Filtration

Quarterly

solids mg/l

affecting shellfish through a 0·45

wa te rs must not µm membrane,

cause

t h e drying at 105ºC

suspended solid and weighing

c o n t e n t o f t h e - Centrifuging

waters to exceed (for at least five

by more than 30% m i n u t e s , w i t h

the content of mean

w a t e r s n o t s o a cc el e ra t io n 2

affected

800 to 3 200g).

drying at 105ºC

and weighing

- < 40 ‰

5. Salinity ‰

12 to 38‰

Conductimetry

Monthly

- Discharge

affecting

shellfish waters

must not cause

their salinity to

exceed by more

than 10% the

salinity

of

waters not so

affected

Minimum

Reference

sampling and

Parameter

G

I

methods of

measuring

analysis

frequency

6. Dissolved

> 80%

- > 70% (average - Winkler’s

M o n t h l y,

oxygen

value)

method

with

a

Saturation %

minimum of

- Should

an - Electro-

one sample

individual

chemical

representa-

m e a s u r e m e n t method

tive of low

indicate a value

oxygen

lower

than

conditions on

70%, measure-

the day of

ments shall be

sampling.

repeated

H o w e v e r,

- An individual

where major

measurement

daily

may

not

variations are

indicate a value

suspected, a

of less than

minimum of

60% unless

two samples

there are no

in one day

harmful

shall

be

consequences

taken

for

the

development of

shellfish

colonies

7. Petroleum

H y d r o c a r b o n s Vi s u a l

Quarterly

hydrocarbons

m u s t n o t b e examination

present in the

shellfish water in

such quantities as

to

- produce

a

visible film on

the surface of

the water and/or

a deposit on the

shellfish,

- have

harmful

e ff e c t s o n t h e

shellfish

8. Organohalo- The

The concentration G a s

Half-yearly

genated

concentration of of each substance chromatography

substances

each substance in i n t h e s h e l l f i s h a f t e r e x t r a c t i o n

shellfish flesh water

or

in with suitable

must

be

so shellfish flesh solvents

and

l i m i t e d t h a t i t must not reach or purification

contributes, in exceed a level

accordance with w h i c h

has

Article 1, to the harmful effects on

h i g h q u a l i t y o f the shellfish and

shellfish products larvae

Minimum

Reference

sampling

and

Parameter

G

I

methods of

measuring

analysis

frequency

9. Metals

The

The concentration Spectrometry of Half-yearly

Ag concentration of of each substance atomic absorption

Silver

As each substance in i n t h e s h e l l f i s h p r e c e d e d w h e r e

Arsenic

Cadmium Cd s h e l l f i s h f l e s h w a t e r o r i n t h e a p p r o p r i a t e , b y

Chromium Cr m u s t

be

so shellfish flesh concentration

l

i

m

i

t

e

d

t

h

a

t

i t must not exceed a and/or extraction

Copper

Cu

Hg c o n t r i b u t e s i n level which gives

Mercury

Ni accordance with r i s e t o h a r m f u l

Nickel

Pb Article 1, to the e f f e c t s o n t h e

Lead

Zn h i g h q u a l i t y o f shellfish and their

Zinc

shellfish products larvae

mg/l

The synergic

e ff e c t s o f t h e s e

metals must be

taken

into

consideration

10. F a e c a l

< 300 in the

Method

o f Quarterly

coliforms/

shellfish flesh

dilution with

100 ml

and intervalvular

fermentation in

liquid (1)

liquid substrates

i n a t l e ast t hr e e

tubes in three

dilutions.

Subculturing of

the positive tubes

on a confirmation

medium. Count

according

to

MPN

(most

probable

number).

Incubation

temperature 44ºC

± 0·5ºC

11. S u b s t a n c e s

C o n c e n t r a t i o n Examination of

affecting the

lower than that the shellfish by

taste of the

l i a b l e t o i m p a i r tasting where the

shellfish

t h e t a s t e o f t h e p r e se n c e o f o n e

shellfish

of

these

substances is

presumed

12. S a x i t o x i n

(produced by

dinoflagellates)

Abbreviations

G = guide

I = mandatory

(1) However, pending the adoption of a Dirrctire on the protection of consumers of shelllish products, it

is essential that this value be observed in waters in which live shelllish directly edible by man.

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