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S.I. No. 784 of
2007
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EUROPEAN
COMMUNITIES (FOODS INTENDED FOR USE IN ENERGY-RESTRICTED DIETS FOR WEIGHT
REDUCTION) REGULATIONS 2007
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Notice of the
making of this Statutory Instrument was published in
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“Iris Oifigiúil”
of 7th December, 2007.
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I, MARY HARNEY,
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 further effect to Commission Directive 96/8/EC 1
of 26 February 1996 on foods intended
for use in energy-restricted diets for weight reduction, and for the purpose
of giving effect to Commission Directive 2007/29/EC 2 of 30 May 2007, amending Directive 96/8/EC
1 as regards labelling, advertising or presenting foods intended for use in
energy-restricted diets for weight reduction, hereby make the following
regulations:—
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PART 1
Preliminary
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1. These
Regulations may be cited as the European Communities (Foods Intended for Use
in Energy-Restricted Diets for Weight Reduction) Regulations 2007.
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2. (1) In
these Regulations—
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“Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29
of 1998);
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“approved examiner” means—
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(a) a Chief Medical
Scientist located at an official laboratory,
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(b) a Consultant
Microbiologist located at an official laboratory,
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(c) a Deputy Public
Analyst located at a Public Analyst’s Laboratory,
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(d) an Executive
Analytical Chemist located at a Public Analyst’s Laboratory,
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(e) a Public Analyst
located at a Public Analyst’s Laboratory,
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(f) a person designated
by the Minister pursuant to Regulation 17;
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“authorised officer” means an authorised officer appointed under section
49 of the Act of 1998;
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“Authority” means the Food Safety Authority of Ireland established under
section 9 of the Act of 1998;
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“Directive” means Commission Directive 96/8/EC 1 of 26 February 1996 on
foods intended for use in energy-restricted diets for weight reduction, as
amended by Commission Directive 2007/29/EC2 of 30 May 2007 as regards
labelling, advertising or presenting foods intended for use in
energy-restricted diets for weight reduction;
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“foods for use in energy-restricted diets for weight reduction” means
specially formulated foods which, when used as instructed by the
manufacturer, replace the whole or part of the total daily diet;
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“General Food Law Regulation” means Regulation (EC) No 178/2002 3
of the European Parliament and of the
Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority,
and laying down procedures in matters of food safety;
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“Health Service Executive” or “HSE” means the
Health Service Executive established under section 6 of the Health Act 2004
(No. 42 of 2004);
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“Minister” means the Minister for Health and Children;
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“official agency” means an official agency carrying out functions under a
service contract and acting on behalf of the Authority pursuant to section
48 of the Act of 1998;
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“Official Controls Regulation” means Regulation (EC) No 882/2004 4
of the European Parliament and of the
Council of 29 April 2004 on official controls performed to ensure the
verification of compliance with feed and food law, animal health and animal
welfare rules;
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“official laboratory” means—
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(a) the Public
Analyst’s Laboratory, Cork,
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(b) the Public
Analyst’s Laboratory, Dublin,
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(c) the Public
Analyst’s Laboratory, Galway,
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(d) the Public Health
Laboratory, HSE, Dublin Mid-Leinster,
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(e) the Public Health
Laboratory, Sligo,
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(f) the Public Health
Laboratory, Waterford,
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(g) the Public Health
Microbiology Laboratory, Cork,
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(h) the Public Health
Microbiology Laboratory, Galway,
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(i)
the Public Heath Microbiology Laboratory, Limerick, or
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(j) a laboratory
designated by the Minister pursuant to Regulation 17;
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“service contract” means a contract entered into between the Authority
and an official agency pursuant to section 48 of the Act of 1998.
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(2) A word
or expression which is used in these Regulations and which is also used in
the Directive or in the General Food Law Regulation has, unless the context
otherwise requires, the same meaning in these Regulations as it has in the
Directive or in the General Food Law Regulation.
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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 Regulations 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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(c) A reference in
these Regulations to a Schedule is to a Schedule to these Regulations,
unless it is indicated that reference to some other Regulations is intended.
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PART 2 General
Provisions
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3. For the
purposes of these Regulations, foods for use in energy-restricted diets for
weight reduction are divided into two categories:
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(a) products presented
as a replacement for the whole of the daily diet;
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(b) products presented
as a replacement for one or more meals of the daily diet.
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4. Foods
for use in energy-restricted diets for weight reduction shall comply with
the compositional criteria specified in Schedule 1.
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5. (1)
Foods for use in energy-restricted diets for weight reduction may be
marketed only if they conform to the provisions of these Regulations.
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(2) The
individual components which make up the products referred to in Regulation
3(a), as sold, shall be contained in the same package.
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(3) The
name under which the product is sold shall be—
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(a) for products
presented as a replacement for the whole of the daily diet: “Total diet
replacement for weight control”, and
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(b) for products
presented as a replacement for one or more meals of the daily diet: “Meal
replacement for weight control”.
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6. The
labelling of foods for use in energy-restricted diets for weight reduction
shall bear the following particulars, in addition to general Community and
national food labelling requirements:
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(a) the available
energy value expressed in kJ and kcal, and the content of proteins,
carbohydrates and fat, expressed in numerical form, per specified quantity
of the product ready for use as proposed for consumption;
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(b) the average
quantity of each mineral and each vitamin for which mandatory requirements
are stipulated in paragraph 5 of Schedule 1, expressed in numerical form,
per specified quantity of the product ready for use as proposed for
consumption;
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(c) instructions for
appropriate preparation, when necessary and a statement as to the importance
of following those instructions;
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(d) if a product, when
used as instructed by the manufacturer, provides a daily intake of polyols in excess of 20g per day, a statement to the
effect that the food may have a laxative effect;
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(e) a statement on the
importance of maintaining an adequate daily fluid intake;
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(f) for products
presented as a replacement for the whole of the daily diet:
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(i)
a statement that the product provides adequate amounts of all essential
nutrients for the day,
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(ii) a statement that the
product should not be used for more than three weeks without medical advice;
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(g) for products
presented as a replacement for one or more meals of the daily diet:
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(i)
a statement to the effect that the products are useful for the intended use
only as part of an energy-restricted diet and that other foodstuffs should
be a necessary part of such diet,
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(ii) in addition to the
information required in paragraph (b) above, information on vitamins
and minerals listed in the Table in Schedule 1, expressed as a percentage of
the values as defined in the Annex to Council Directive 90/496/EEC 5
of 24 September 1990 on nutrition
labelling for foodstuffs.
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7. The
labelling, advertising and presentation of foods for use in
energy-restricted diets for weight reduction shall not make any reference to
the rate or amount of weight loss which may result from their use.
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PART 3
Enforcement
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8. (1) The
enforcement of these Regulations and of the Directive shall be carried out
in accordance with the provisions of these Regulations.
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(2) These
Regulations shall be deemed to be food legislation for the purposes of the
Act of 1998.
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(3) These
Regulations shall be enforced by the Authority or by an official agency
acting pursuant to a service contract with the Authority, or by both, and,
without prejudice to paragraph (1), the enforcement provisions contained in
the Act of 1998 shall apply for the purposes of ensuring compliance with the
requirements of these Regulations.
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9. (1) An
authorised officer may, for the purposes of these Regulations, purchase or
take without payment a sample of foods for use in energy-restricted diets for
weight reduction or other relevant substance.
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(2) An
authorised officer may, for the purpose of taking a sample of foods for use
in energy-restricted diets for weight reduction or other relevant substance,
open any receptacle.
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(3) Where
an authorised officer purchases or takes without payment a sample of foods
for use in energy-restricted diets for weight reduction or other relevant
substance with the intention of having it analysed, he or she shall after
purchasing or taking the sample forthwith notify the food business operator,
or the person in apparent charge or control of the foods for use in
energy-restricted diets for weight reduction or other substance of his or
her intention of having the sample analysed.
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(4) Where
an authorised officer purchases or takes without payment, with the intention
of having it analysed, a sample of foods for use in energy-restricted diets
for weight reduction or other relevant substance which is suspected by him
or her to fail to comply with the provisions of these Regulations, he or she
may, by notice in writing to the food business operator, or the person in
apparent charge or control of such foods or other substances, prohibit their
removal except to any place which may be specified in the notice, during
such period as may be specified in the notice, but not exceeding 15 days
from the date of the taking of the sample.
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10. (1)
Where a sample of foods for use in energy-restricted diets for weight
reduction or other relevant substance is taken pursuant to these
Regulations, for the purposes of official analysis and where the division of
the sample is reasonably practicable, the authorised officer concerned may
divide the sample into three approximately equal parts, (enforcement, trade
(defence) and referee), each of which he or she shall mark in such a way as
to identify it as a part of the sample taken by the officer. The authorised
officer shall, in the presence of the food business operator, or the person
in apparent charge or control of such food—
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(a) mark, seal and
fasten each part in such a manner as its nature will permit, and in such a
way that the integrity of the sample is not compromised;
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(b) forward one part to
the approved examiner in an official laboratory for analysis;
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(c) give or send one
part to the food business operator, and
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(d) retain the third
part.
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(2) Where
an authorised officer takes a sample consisting of foods for use in
energy-restricted diets for weight reduction or other relevant 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 provisions 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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(3) In
proceedings for an offence under these Regulations, the result of any test,
examination or analysis of, or report on a sample of foods for use in
energy-restricted diets for weight reduction or other relevant substance
taken pursuant to these Regulations, shall not be adduced unless before the
proceedings were instituted the sample was divided as specified in
paragraphs (1) and (2) of this Regulation. The part, package or container
retained by the authorised officer shall be produced at the hearing.
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11. (1) The
approved examiner or a person under his or her direction shall analyse as
soon as possible any sample of foods for use in energy-restricted diets for
weight reduction or other relevant substance submitted to him or her in pursuance
of these Regulations and the approved examiner shall certify to the person
who submitted the sample to him or her the result of such analysis. The form
of certificate set out in Schedule 3 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) shall be prima
facie evidence of the matters contained therein until the contrary is
proved.
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12. Where a
sample of foods for use in energy-restricted diets for weight reduction or
other relevant substance is taken by an authorised officer in pursuance of
these Regulations for analysis by an approved examiner, the Authority, or an
official agency as the case may be, shall draw up a report in accordance
with Article 9 of the Official Controls Regulation, where the certificate
given in accordance with Regulation 11 indicates that there has been
non-compliance with these Regulations, the Authority, or the official
agency, as the case may be, shall provide the food business operator with a
copy of the report.
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13. An
authorised officer may, for the purposes of these Regulations, inspect and
take copies, or samples, of labels used on foods for use in
energy-restricted diets for weight reduction or other relevant substance.
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14. The
provisions of Regulations 9, 10, 11, 12 and 13 shall also apply in respect
of—
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(a) products which are
not foods for use in energy-restricted diets for weight reduction, as
defined in Regulation 2(1), but which are being placed on the market as
such, and
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(b) any other products
which the authorised officer suspects are being treated, manufactured or
placed on the market in contravention of these Regulations.
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15. (1) An
authorised officer may, for the purposes of these Regulations, seize,
remove, detain or direct the withdrawal from the market of any foods for use
in energy-restricted diets for weight reduction, or other products, which
are suspected by him or her to fail to comply with the provisions of these
Regulations.
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(2) An
authorised officer may, with the consent in writing of the food business
operator, or the person in apparent charge or control of such foods for use
in energy-restricted diets for weight reduction or other products or in
accordance with an order of a judge of the District Court under paragraph
(4) of this Regulation, destroy or otherwise dispose of same so as to
prevent them being used for human consumption.
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(3) An
authorised officer who has seized, removed, detained or directed the
withdrawal from the market of foods for use in energy-restricted diets for
weight reduction or other products in pursuance of the provisions of this
Regulation may, on giving notice in writing to the food business operator of
his or her intention to do so, apply to a judge of the District Court for an
order directing that such products be destroyed or otherwise disposed of.
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(4) A judge
of the District Court, to whom an application is made for an order under
paragraph (3), may, if satisfied that such foods or products fail to comply
with these Regulations, order that they be destroyed or otherwise disposed
of, after such period, not exceeding 14 days, as may be specified in such
order, and an authorised officer shall destroy or dispose of them
accordingly.
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16. Where
an authorised officer has reasonable grounds for believing that a person has
contravened any provision of these Regulations and so informs that person,
the authorised officer may require that person to state his or her name and
address and, if the authorised officer thinks it necessary, to produce
corroborative evidence of same.
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17. The
Minister may, for the purposes of these Regulations designate, by notice in
writing published in Iris Oifigiúil—
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(a) a laboratory as a
laboratory at which samples taken under these Regulations may be analysed,
and testing and verification may be carried out, and
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(b) a person as being a
person who, or a class of persons the members of which, may, at a designated
laboratory, engage in analysis, testing and verification for the purposes of
these Regulations.
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18. (1) A
person is guilty of an offence if he or she fails to comply with these
Regulations.
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(2)
Paragraph (1) shall not apply to an authorised officer or an approved
examiner acting in the course of his or her duties pursuant to these
Regulations.
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(3) A
person is guilty of an offence if he or she—
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(a) obstructs or
interferes with an authorised officer in the exercise of the officer’s
powers under these Regulations,
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(b) fails or refuses to
state his or her name or address in compliance with a request under these
Regulations,
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(c) fails to comply
with a request or notice from an authorised officer under these Regulations,
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(d) makes a statement
to an authorised officer which the person knows is false or misleading, or
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(e) gives in purported
compliance with a request under these Regulations a name, address or
corroborative evidence which is false or misleading.
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19. 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 attributed
to any neglect or default 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 is also guilty of an offence and is liable to
be proceeded against and punished as if he or she were guilty of the
first-mentioned offence.
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20. (1) A
person is guilty of an offence if he or she forges, or utters knowing it to
be forged, a certificate of analysis or other document purporting to be
issued, granted or given under these Regulations or required for the
purposes of these Regulations, (hereafter referred to as “a forged
document”).
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(2) A
person is guilty of an offence if he or she alters with intent to defraud or
deceive, or who utters knowing it to be so altered, a certificate of
analysis or other document issued, granted or given under these Regulations,
or required for the purposes of these Regulations (hereafter referred to as
“an altered document”).
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(3) A
person is guilty of an offence if he or she without lawful authority, has in
his or her possession a forged document or an altered document, knowing it
to be a forged or altered document as the case may be.
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(4) A
person is guilty of an offence if he or she with the intent to defraud or
deceive—
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(a) tampers with any
substance or thing with the result that a sample taken pursuant to these
Regulations does not correctly represent the substance sampled, or
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(b) tampers or
interferes with any sample taken under these Regulations.
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(5) A person
is guilty of an offence if he or she falsely represents himself or herself
to be an authorised officer.
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21. (1) For
the purposes of these Regulations, every contravention of a Regulation shall
be deemed a separate contravention and every contravention of a paragraph or
a subparagraph shall also be deemed to be a separate contravention and shall
carry the same penalty as for a single contravention of any Regulation.
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(2) A
person who is guilty of an offence under these Regulations is liable—
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(a) on summary
conviction to a fine not exceeding €5,000 or at the discretion of the Court
to imprisonment for a term not exceeding 3 months or both, or,
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(b) on conviction on
indictment, to a fine not exceeding €500,000, or imprisonment for a term not
exceeding 3 years, or both.
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22.
Notwithstanding section 57 of the Act of 1998, a summary offence under these
Regulations may be prosecuted by—
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(a) the Authority, or
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(b) an official agency
or both.
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PART 4 Revocation
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23. (1) The
European Communities (Foods Intended for Use in Energy-Restricted Diets for
Weight Reduction) Regulations 1998 ( S.I. No. 242 of 1998 ) are 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 1
ESSENTIAL COMPOSITION OF FOODS FOR ENERGY RESTRICTED DIETS
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The specifications refer to
the products ready for use, marketed as such or reconstituted as instructed
by the manufacturer.
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1. Energy
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1.1 The energy provided by a product mentioned in Regulation 3(a)
shall not be less than 3,360 kJ (800 kcal) and shall not exceed 5,040 kJ
(1,200 kcal) for the total daily ration.
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1.2 The energy provided by a product mentioned in Regulation 3(b)
shall not be less than 840 kJ (200 kcal) and shall not exceed 1,680 kJ (400
kcal) per meal.
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2. Protein
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2.1 The protein contained in products mentioned in Regulation 3(a)
and (b) shall provide not less than 25% and not more than 50% of the
total energy of the product. In any case the amount of protein of products
mentioned in Regulation 3(a) shall not exceed 125g.
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2.2 The abovementioned provisions on protein refer to a protein the
chemical index of which is equal to that of the FAO/WHO (1985) reference
protein given in Schedule 2. If the chemical index is lower than 100% of the
reference protein, the minimum protein levels shall be correspondingly
increased. In any case the chemical index of the protein shall at least be
equal to 80% of that of the reference protein.
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2.3 The ‘chemical index’ shall mean the lowest of the ratios between the
quantity of each essential amino acid of the test protein in and the
quantity of each corresponding amino acid of the reference protein.
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2.4 In all cases, the addition of amino acids is permitted solely for the
purpose of improving the nutritional value of the proteins, and only in the
proportions necessary for that purpose.
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3. Fat
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3.1 The energy derived from fat shall not exceed 30% of the total
available energy of the product.
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3.2 For products mentioned in Regulation 3(a), the linoleic acid (in the form of glycerides)
shall not be less than 4.5g.
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3.3 For products mentioned in Regulation 3(b), the linoleic acid (in the form of glycerides)
shall not be less than 1g.
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4. Dietary fibre
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The dietary fibre content of products mentioned in Regulation 3(a)
shall not be less than 10g and shall not exceed 30g for the daily ration.
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5. Vitamins and minerals
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5.1 The products mentioned in Regulation 3(a) shall provide for
the whole of the daily diet at least: 100% of the amounts of vitamins and
minerals specified in the Table.
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5.2 The products mentioned in Regulation 3(b) shall provide at
least 30% of the amounts of vitamins and minerals specified in the Table per
meal; however, the amount of potassium per meal provided by these products
shall be at least 500mg.
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TABLE
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Vitamin A
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(g RE)
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700
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Vitamin D
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(g)
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5
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Vitamin E
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(mg-TE)
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10
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Vitamin C
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(mg)
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45
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Thiamin
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(mg)
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1.1
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Riboflavin
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(mg)
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1.6
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Niacin
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(mg-NE)
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18
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Vitamin B 6
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(mg)
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1.5
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Folate
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(g)
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200
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Vitamin B 12
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(g)
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1.4
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Biotin
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(g)
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15
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Pantothenic acid
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(mg)
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3
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Calcium
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(mg)
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700
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Phosphorus
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(mg)
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550
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Potassium
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(mg)
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3,100
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Iron
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(mg)
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16
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Zinc
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(mg)
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9.5
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Copper
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(mg)
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1.1
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Iodine
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(g)
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130
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Selenium
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(g)
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55
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Sodium
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(mg)
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575
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Magnesium
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(mg)
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150
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Manganese
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(mg)
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1
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SCHEDULE 2 AMINO
ACID REQUIREMENT PATTERN(1)
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g/100g protein
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|
Cystine + methionine
|
1.7
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|
Histidine
|
1.6
|
|
Isoleucine
|
1.3
|
|
Leucine
|
1.9
|
|
Lysine
|
1.6
|
|
Phenylalanine + tyrosine
|
1.9
|
|
Threonine
|
0.9
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|
Tryptophan
|
0.5
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|
Valine
|
1.3
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|
|
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(1) World Health
Organisation. Energy and protein requirements. Report of a Joint FAO/WHO/UNU Meeting. Geneva: World Health Organisation, 1985.
(WHO Technical Report Series, 724).
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SCHEDULE 3 Form of
official certificate to be given by an approved examiner to anauthorised officer.
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European
Communities
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(Foods Intended for Use in
Energy-Restricted Diets for Weight Reduction) Regulations 2007
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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 an Approved Examiner
for the purpose of the above Regulations certify that on
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..................................
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was submitted to me by you
and I certify that the sample was prepared and analysed/examined by me or
under my direction (4)
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and as a result I am of the
opinion that (5)
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Observations: (6)
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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 (7)
.....................................
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Name in BLOCK
LETTERS...............................................................
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Status...........................................................
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Signature.........................................................
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Official Stamp
999999999999
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NOTES
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(1) Insert the name and
address of the person submitting the sample for analysis.
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(2) Insert description (e.g.
Executive Analytical Chemist located at a Public Analyst Laboratory).
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(3) Insert particulars of
marking (e.g. name, date etc.) and the weight or measure (this may be left
unanswered if the sample cannot be conveniently weighed or measured or if
the weight or measurement is not material to the result of analysis).
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(4) Indicate whether the
approved examiner carried out the analysis himself or herself or whether it
was carried out by another under the direction of the approved examiner.
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(5) Here the approved
examiner should specify the result of the analysis having regard to the
provisions of the relevant legislation.
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(6) Here the approved
examiner may insert, at his or her discretion, his or her 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 or
she may add any other observations as he or she may consider relevant.
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(7) Insert the name and
address of the laboratory carrying out the analysis/examination.
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GIVEN under my Official Seal,
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29 November 2007
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MARY HARNEY.
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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
further effect to Commission Directive 96/8/EC of 26 February 1996 on foods
intended for use in energy-restricted diets for weight reduction. These
Regulations also give effect to Commission Directive 2007/29/EC of 30 May
2007 amending Directive 96/8/EC as regards labelling, advertising or
presenting foods intended for use in energy-restricted diets for weight
reduction.
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These Regulations revoke the
European Communities (Foods Intended for Use in Energy-Restricted Diets for
Weight Reduction) Regulations 1998 ( S.I. No. 242 of 1998 ).
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These Regulations may be
cited as the European Communities (Foods Intended for Use in
Energy-Restricted Diets for Weight Reduction) Regulations 2007.
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1 OJ L 55,
6.3.1996, p. 22.
2 OJ L 139,
31.5.2007, p. 22.
3 OJ L 31,
1.2.2002, p. 1, as amended.
4 OJ L 165,
30.4.2004, p. 1, as affected by the Corrigendum to Regulation (EC) No
882/2004, OJ L 191, 28.5.2004, p. 1.
5 OJ L 276,
6.10.1990, p. 40.
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