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Statutory
Instrument |
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S.I. No.
141 of 2000 |
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European
Communities (Extraction Solvents in Foodstuffs and Food Ingredients)
Regulations, 2000 |
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Dublin |
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Published by the Stationery Office |
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S.I. No. 141 of
2000 |
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European
Communities (Extraction Solvents in Foodstuffs and Food Ingredients)
Regulations, 2000 |
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I, Micheál Martin,
Minister for Health and Children, in exercise of the powers conferred on
me by section 3 of the European Communities Act, 1972 ( No 27 of 1972 ),
and for the purpose of giving effect to Council Directive
88/344/EEC1 of 13 June 1988 on
the approximation of the laws of the Member States on extraction solvents
used in the production of foodstuffs and food ingredients, as amended by
Council Directive 92/115/EEC2 of 17 December 1992, Directive 94/52/EC3 of the European Parliament and of the
Council of 7 December 1994 and Directive 97/60/EC4 of the European Parliament and of the
Council of 27 October 1997, hereby make the following
Regulations: |
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1.
These Regulations may be cited as the European
Communities (Extraction Solvents in Foodstuffs and Food Ingredients)
Regulations, 2000. |
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2. (1)
In these Regulations - |
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“the Act of 1998” means the Food
Safety Authority of Ireland Act, 1998 (No.29 of 1998) ; |
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“Annex” means the Annex to the
Directive; |
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“authorised officer” means a person
appointed as an authorised officer under Regulation 15; |
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“the Directive” means Council
Directive 88/344/EEC1 of 13
June, 1988 on the approximation of the laws of the Member States on
extraction solvents used in the production of foodstuffs and food
ingredients, as amended by Council Directive 92/115/EEC2 of 17 December 1992, Directive
94/52/EC3 of the European
Parliament and of the Council of 7 December 1994 and Directive
97/60/EC4 of the European
Parliament and of the Council of 27 October 1997; |
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“extraction solvent” means a solvent
which is used in an extraction procedure during the processing of raw
materials, of foodstuffs, or of components or ingredients of these
products and which is removed but which may result in the unintentional,
but technically unavoidable presence of residues or derivatives in the
foodstuff or food ingredient; |
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“functional area” in relation to a
health board established under section 4 (1) of the Health Act, 1970 (No.
1 of 1970) , means the functional area of the health board as specified in
the Health Board Regulations, 1970 ( S.I. No. 170 of 1970 ) and in
relation to the Eastern Regional Health Authority established under
section 7 of the Health (Eastern Regional Health Authority) Act, 1999 (
No. 13 of 1999 ) (“the Act of 1999”), means the functional area of the
Authority as specified in section 7(4) of the Act of 1999; |
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“health board” means a health board
established under section 4 (1) of the Health Act, 1970 (No. 1 of 1970)
and the Eastern Regional Health Authority established under section 7 of
the Act of 1999; |
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“solvent” means any substance for
dissolving a foodstuff or any component thereof, including any contaminant
present in or on that foodstuff; |
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“to market”
includes to supply (whether or not for profit), offer for sale, expose for
sale and have in possession for sale, and cognate words shall be construed
accordingly. |
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(2) A
word or expression that is used in these Regulations and that is also used
in the Directive, has, unless the context otherwise requires, the same
meaning in these Regulations that it has in the Directive. |
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(3)
(a) A
reference in these Regulations to a Regulation is to a Regulation of these
Regulations, unless it is indicated that reference to some other
Regulation is intended. |
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(b) A
reference in these Regulations to a paragraph or subparagraph is to the
paragraph or subparagraph of the provision in which the reference occurs,
unless it is indicated that reference to some other provision is
intended. |
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3.
(1) Subject to paragraph (2), the
extraction solvents to which these Regulations apply and any foodstuffs
containing any such extraction solvent may be marketed only if they comply
with the provisions laid down in these Regulations and the
Directive. |
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(2) Extraction
solvents to which these Regulations apply and any foodstuffs containing
any such extraction solvents placed on the market or labelled before the
27th April, 1999, and not complying with these Regulations and the
Directive may be marketed until stocks are used up. |
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4.
(1) Subject to paragraph (2) these
Regulations shall apply to extraction solvents used or intended for use in
the production of foodstuffs or food ingredients. |
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(2) These
Regulations shall not apply to extraction solvents used in the production
of food additives, vitamins and other nutritional additives, unless such
food additives, vitamins or nutritional additives are listed in the
Annex. |
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(3) Notwithstanding
paragraph (2), the use of food additives, vitamins and other nutritional
additives shall not result in foodstuffs containing extraction solvent
residue levels dangerous to human health. |
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5.
Only those substances and materials listed in the
Annex may be used as extraction solvents in the manufacture of foodstuffs
or food ingredients, under the conditions of use and where appropriate
within the maximum residue limits therein specified. |
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6.
Without prejudice to Regulation 5, the Food Safety
Authority of Ireland may, on application made to it in writing in that
behalf, authorise the use of substances used for
diluting or dissolving flavourings as solvents for the extraction of
flavourings from natural flavouring materials. |
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7.
Without prejudice to Regulation 5, water, to which
substances regulating acidity or alkalinity may have been added, other
food substances which possess solvent properties and ethanol may be used
as extraction solvents in the manufacture of foodstuffs or food
ingredients. |
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8.
The substances and materials listed as extraction
solvents in the Annex shall satisfy the following purity
criteria: |
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(a)
they shall not contain a toxicologically dangerous
amount of any element or substance; |
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(b)
subject to any exceptions deriving from the specific
purity criteria referred to in paragraph (c), they shall not contain more
than 1 mg/kg of arsenic or more than 1 mg/kg of lead; |
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(c)
they shall satisfy the specific
purity criteria determined in accordance with Article 4 of the
Directive. |
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9.
Where the Food Safety Authority of Ireland
considers that the use in foodstuffs of any extraction solvent listed in
the Annex, or the level of one or more of the components referred to in
Article 3 of the Directive contained in such extraction solvent, may
endanger human health (notwithstanding that it complies with the
conditions prescribed in these Regulations), it may take such measures as
it considers appropriate, including the temporary suspension or
restriction of trade in that extraction solvent or in any foodstuff
containing that extraction solvent or component. |
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10.
(1) The substances listed in the Annex and
intended for use as extraction solvents in foodstuffs shall not be
marketed unless their packaging, containers or labels carry the following
information in such a way as to be easily visible, clearly legible and
indelible: |
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(a)
the commercial name as given in the Annex; |
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(b)
a clear indication that the material is of a quality
suitable for use for the extraction of food or food ingredients; |
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(c)
a reference by which the batch or lot may be
identified; |
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(d)
the name or business name and address of the
manufacturer or packer or of a seller established within the
Community; |
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(e)
the net quantity given as units of volume; |
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(f)
if necessary, the special
storage conditions or conditions of use. |
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(2)
Notwithstanding paragraph (1), the information specified in
sub- paragraphs (c), (d), (e) and (f) of that paragraph may appear merely
on the trade documents relating to the batch or lot which are to be
supplied with or prior to the delivery. |
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(3)
This Regulation is without prejudice to more precise or more
extensive Community provisions regarding weights and measures or
provisions applying to the classification, packaging and labelling of
dangerous substances and preparations. |
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(4)
The information required in this Regulation shall be given in
the English language (unless other measures have been taken to ensure that
the purchaser is informed) and may, in addition, be given in the Irish
language or any other language. |
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11.
(1) These Regulations shall apply equally to
extraction solvents used or intended for use in the production of
foodstuffs or ingredients imported into the Community. |
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(2)
These Regulations shall not apply to extraction solvents or
foodstuffs intended for export outside the Community. |
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12.
These Regulations shall be deemed to be food legislation for
the purposes of the Act of 1998 and the enforcement provisions contained
in that Act shall accordingly apply for the purpose of ensuring compliance
with these Regulations. |
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13.
(1) Without prejudice to Regulation 12, the powers
contained in the European Communities (Official Control of Foodstuffs)
Regulations, 1998 ( S.I. No. 85 of 1998 ), as amended, may be exercised
for the purpose of ensuring compliance with these Regulations. |
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(2) An
official certificate given in accordance with sub-article (1) of article
14 of the said Regulations of 1998, as amended, may be adduced in evidence
in a prosecution under these Regulations and shall be prima facie evidence
of the matters contained therein, until the contrary is proved. |
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14.
Without prejudice to Regulations 12 and 13, before entry into
a service contract by a health board with the Food Safety Authority of
Ireland under the Act of 1998, the powers contained in Regulations 15 to
19 may be exercised for the purpose of ensuring compliance with these
Regulations. |
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15.
(1) The Chief Executive Officer of a health board
may appoint in writing such and so many officers of the health board as he
or she thinks fit to be authorised officers for the purposes of ensuring
compliance with these Regulations in the functional area of the health
board. |
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(2) A
person appointed as an authorised officer under the Health (Extraction
Solvents in Foodstuffs) Regulation, 1995 ( S.I. No. 283 of 1995 ) and
holding office as an authorised officer immediately before the making of
these Regulations shall continue in office as if appointed under this
Regulation. |
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(3) An
authorised officer shall be furnished with a certificate of his
appointment as an authorised officer and, when exercising any power
conferred on an authorised officer under these Regulations, shall, if
requested by any person affected, produce the certificate to that
person. |
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16.
(1) An authorised officer may for the purpose of
ensuring that these Regulations are being complied with - |
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(a)
require any employee of the health board, a former
employee of the health board or any person otherwise currently or
previously retained by the health board, or any person who carries or has
carried on any trade, business or activity to which these Regulations
relate or any person currently or previously employed in connection with
that trade, business or activity to produce to him or her such records,
and in the case of such information in a non-legible form to reproduce it
in a permanent legible form, or to give him or her such information, as
the officer may reasonably require in relation to any entries in such
records, |
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(b) at
all reasonable times enter any premises, subject to paragraph (2), at
which there are reasonable grounds to believe that any trade, business or
activity in connection with the production, processing, disposal,
manufacture, exportation, importation, storage, distribution, sale,
marketing or labelling for the purposes of marketing of any extraction
solvent or foodstuff to which these Regulations apply is or has been
carried on, or that records in relation to such trade, business or
activity are kept, and search and inspect the premises and any extraction
solvent, foodstuff, label or records found in or on the
premises, |
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(c)
secure for later inspection any premises or any part thereof
in which such extraction solvent, foofstuff,
label or records are kept or there are reasonable grounds for believing
that such extraction solvent, foodstuff, label or records are
kept, |
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(d)
require any person in charge thereof or so employed therein,
to produce to the officer such records and to give to the officer such
information as the officer may reasonably require in relation to any
entries in such records, |
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(e)
inspect and take copies of or extracts from any such
records (including in the case of information in a non-legible form a copy
of or extract from such information in a permanent legible
form), |
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(f)
remove and retain the said extraction solvent,
foodstuff, labels or records for such period as may be reasonable for
further examination or until the conclusion of any legal
proceedings, |
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(g)
as regards any extraction solvent or foodstuff or any
article or substance used in the manufacture or preparation of a
extraction solvent or foodstuff the officer finds at or in a premises,
require any person in charge thereof or any person who appears to the
officer to be in possession of the extraction solvent or foodstuff or the
article or substance, to supply without payment, for test, examination or
analysis sufficient samples thereof, |
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(h)
require any person to afford the officer such facilities
and assistance within his or her control or responsibilities as are
reasonably necessary to enable the officer to exercise any of the powers
conferred on an authorised officer under this Regulation, |
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(i) require a person referred
to in subparagraph (a) to give to the officer any information which the
officer may reasonably require in regard to the trade, business or
activity or in regard to the persons carrying on such trade, business or
activity or employed in connection with that trade, business or
activity, |
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(j)
require any person referred to in subparagraph (a)
by or on whose behalf data equipment is or has been used in relation to a
business within the meaning of subparagraph (b) or any person having
charge of, or otherwise concerned with the operation of, the data
equipment or any associated apparatus or material, to afford the officer
all reasonable assistance in relation to its use thereto, |
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(k)
summon, at any reasonable time, any other person being or
having been an employee of the health board or retained or having been
retained by the health board or employed in connection with the trade,
business or activity under examination by the health board to give to the
officer any information which the officer may reasonably require in regard
to that trade, business or activity and to produce to the officer any
records which are in that person's power or control; |
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(l)
examine any procedure connected with the
manufacture of an extraction solvent or foodstuff, and |
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(m)
exercise such other powers as may be
necessary to ensure that these Regulations are being complied
with. |
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(2) An
authorised officer shall not, other than with the consent of the occupier,
enter a private dwelling unless he or she has obtained a warrant from the
District Court under paragraph (5) authorising such entry. |
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(3)
Where an authorised officer in the exercise of the officer's
powers under this Regulation is prevented from entering any premises an
application may be made to the District Court under paragraph (5) for a
warrant authorising such entry. |
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(4) An
authorised officer where he considers is necessary, may be accompanied by
a member of the Garda Síochána when performing any powers conferred on an
authorised officer under this Regulation. |
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(5) If
a judge of the District Court is satisfied on the sworn information of an
authorised officer that there are reasonable grounds for suspecting that
there is information required by an authorised officer under this
Regulation held on or in any premises [or any part of any premises or
there is a product which an authorised officer requires to inspect for
purposes of these Regulations or that such inspection is likely to
disclose evidence of a contravention of these Regulations], the judge may
issue a warrant authorising an authorised officer, accompanied, if
appropriate, by other authorised officers or by a member of the Garda Síochána, at any time
or times within one month from the date of issue of the warrant, on
production, if so requested, of the warrant, to enter, if need be by
reasonable force, the premises and exercise all or any of the powers
conferred on an authorised officer under this Regulation. |
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(6) An
application under paragraph (5) shall be made to the judge of the District
Court in whose district court district the premises is situated. |
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17.
(1) Where a sample of any product, article or
substance is supplied pursuant to paragraph (1)(g) of Regulation 16 and where the division of the
sample is reasonably practicable, the authorised officer concerned may
divide the sample into not more than three approximately equal parts each
of which he shall mark in such a way as to identify it as a part of the
sample taken by the officer. The authorised officer shall mark, seal and
fasten each part in such a manner as its nature will permit, forward one
part to a laboratory approved under the European Communities (Official
Control of Foodstuffs) (Approved Laboratories) Order, 1998 ( S.I. No. 95
of 1998 ), where it may be tested, examined or analysed for the purposes
of these Regulations by an approved examiner, within the meaning of the
European Communities (Official Control of Foodstuffs) Regulations, 1998,
as amended, give or send one part to the seller, owner or person in
apparent charge or control of the product, article or substance and retain
the third part. |
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(2)
Where an authorised officer takes a sample consisting of a
product, article or substance contained in unopened containers and its
division into parts— |
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(a) is
not reasonably practicable, or |
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(b)
might affect the composition or impede the proper analysis of
the sample, |
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the provision
of paragraph (1) as regards the division of samples into parts shall be
deemed to be complied with if the authorised officer divides the
containers into three lots and deals with each lot as if it were a sample
as specified under paragraph (1). |
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18.
(1) The approved examiner within the meaning of
Regulation 17(1) or a person under his direction shall analyse as soon as
possible any sample of a product, article or substance submitted to him in
pursuance of these Regulations and the approved examiner shall certify to
the person who submitted the sample to him the result of such analysis. If
the sample is found to be diseased, contaminated or otherwise unfit for
human consumption, the form of certificate set out in the Schedule to
these Regulations or a certificate in like form shall be used. |
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(2) An
official certificate given in accordance with paragraph (1) may be adduced
in evidence in a prosecution under these Regulations and shall be prima
facie evidence of the matters contained therein, until the contrary is
proved. |
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19.
Where a sample of a product, article or substance is taken by
an authorised officer in pursuance of these Regulations for analysis by an
approved examiner, and where the seller, owner or person in apparent
charge or control of such item requests in writing the results of such
analysis, the request shall be made to the health board in whose area the
sample was taken and the health board shall comply with such
request. |
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20.
(1) A person who fails to comply with Regulation 3
shall be guilty of an offence. |
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(2)
A person who falsely represent
himself to be an authorised officer shall be guilty of an
offence. |
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(3)
A person who - |
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(a)
obstructs or interferes with an authorised officer in the
exercise of the officer's powers under Regulation 16, or |
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(b)
fails to comply with a request from an authorised officer
under Regulation 16, or |
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(c)
makes a statement to an authorised officer which the person
knows is false or misleading, |
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shall be
guilty of an offence. |
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(4) A
person who is guilty of an offence under these Regulations shall be liable
on summary conviction to a fine not exceeding £1,500 or at the discretion
of the Court to imprisonment for a term not exceeding six months, or
both. |
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21.
Where an offence under these Regulations is committed by a
body corporate or by a person acting on behalf of a body corporate and is
proved to have been so committed with the consent, connivance or approval
of, or to be attributable to any neglect on the part of any director,
manager, secretary or any other officer of such body or a person who was
purporting to act in any such capacity, such person shall also be guilty
of an offence and shall be liable to be proceeded against and punished as
if he were guilty of the first-mentioned offence. |
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22. An
offence under these Regulations may be prosecuted by the health board in
whose functional area the offence was committed. |
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23.
(1) The Health (Extraction Solvents in Foodstuffs)
Regulation, 1995 ( S.I. No. 283 of 1995 ) are
hereby revoked. |
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(2)
References in any other instrument to the Regulations revoked
under paragraph (1) shall be construed as references to these Regulations,
as appropriate. |
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Schedule |
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Form of official certificate to be given by
an approved examiner to an authorised officer. |
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European
Communities |
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(Extraction Solvents in
Foodstuffs and Food Ingredients) |
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Regulations, 2000 |
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Certificate of Analysis |
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To (1) .............................. |
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I, the undersigned (2) ................................... |
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being the Approved Examiner for the purpose
of Regulations 17 and 18 of the above Regulations certify that
on |
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the
.......................... day of
..........................20.......... |
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a sample marked (3)
................................ |
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Date
......................................... |
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Number
....................................... |
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Weight or Measure (4) ...................... |
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was submitted to me by you and I certify
that the sample has been analysed/examined by me or under my direction (5)
and as a result I am of the opinion
that (6) |
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Observations : (7) |
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I further certify that the sample has
undergone no change which would affect my opinion/observations expressed
above. |
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Certified by me this
....................... day of
..................... 20.............. |
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at (8) .................................. |
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Name in BLOCK LETTERS
........................ Status ......................... |
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Signature
................................ |
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________________________ |
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Official Stamp |
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NOTES |
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GIVEN under my official seal this 25th
day of May, 2000 |
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Micheál Martin |
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________________________ |
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Minister for Health and
Children |
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Explanatory
Note |
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(This note is not part of the Instrument and
does not purport to be a legal interpretation). |
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These Regulations give effect to Council
Directive 88/344/EEC of 13 June 1988 as amended by Council Directive
92/115/EEC, Directive 94/52/EC and Directive 97/60/EC which lay down
specific provisions for extraction solvents used or intended for use in
the production of foodstuffs or food ingredients. |
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These Regulations revoke the Health
(Extraction Solvents in Foodstuffs) Regulation, 1995 (
S.I. No. 283 of 1995 ). |
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1 1 OJ No. L157, 24.6.88, p.28
2 2 OJ No. L409, 31.12.92, p.31
3 3 OJ No. L331, 21.12.94, p.10
4 4 OJ No. L331, 3.12.97, p.7
1 1 OJ No. L157, 24.6.88, p.28
2 2 OJ No. L409, 31.12.92, p.31
3 3 OJ No. L331, 21.12.94, p.10
4 4 OJ No. L331, 3.12.97, p.7
(1) Insert the name and address of the person
submitting the sample for analysis.
(2) Insert description (i.e. officer of Health
Board etc.)
(3) Insert particulars of marking (e.g. name,
date etc.)
(4) This may be left unanswered if the sample
cannot be conveniently weighed or measured or the weight or measurement is
not material to the result of analysis.
(5) State whether the analysis was carried out
by an approved examiner or under his direction by deleting appropriate
words (“by me” or “under my direction”).
(6) Here the approved examiner should specify
the result of the analysis having regard to the provision of relevant
legislation.
(7) Here the approved examiner may insert, at
his discretion, his opinion whether the analysis indicates any addition,
abstraction, deficiency or the presence of foreign matter or other defect
and whether the composition or quality is thereby affected; any physical,
chemical or other properties bearing on the composition or quality of the
article; whether the article is injurious to health or unfit for human
consumption; whether and in what respect a label and description relating
to the sample is incorrect or misleading; and he may add any other
observations as he may consider relevant.
(8) Insert the name and address of the
laboratory carrying out the
analysis/examination. |