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S.I. No. 776 of
2007
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EUROPEAN
COMMUNITIES (PROCESSED CEREAL-BASED FOODS AND BABY FOODS FOR INFANTS AND
YOUNG CHILDREN) REGULATIONS 2007
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Notice of the
making of this Statutory Instrument was published in
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“Iris Oifigiúil”
of 30th November, 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 effect to Commission Directive 2006/125/EC 1
of 5 December 2006 on processed
cereal-based foods and baby foods for infants and young children, 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 (Processed Cereal-Based
Foods and Baby Foods for Infants and Young Children) 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 15;
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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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“baby foods” means foodstuffs, other than processed cereal-based foods,
for particular nutritional use fulfilling the particular requirements of infants
and young children in good health and intended for use by infants while they
are being weaned, and by young children as a supplement to their diet or for
their progressive adaptation to ordinary food, or both;
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“Directive” means Commission Directive 2006/125/EC 1 of 5 December 2006
on processed cereal-based foods and baby foods for infants and young
children;
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“General Food Law Regulation” means Regulation (EC) No. 178/2002 2
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” (HSE) means the
Health Service Executive, established under section 6 of the Health Act 2004
(No. 42 of 2004);
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“infants” means children under the age of 12 months;
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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 3
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” in these Regulations 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 15;
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“pesticide residue” means the residue in processed cereal-based foods and
baby foods of a plant protection product, as defined in point 1 of Article 2
of Council Directive 91/414/EEC 4 ,
including its metabolites and products resulting from its degradation or
reaction, and cognate words shall be construed accordingly;
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“processed cereal-based foods” means foodstuffs for particular
nutritional use fulfilling the particular requirements of infants and young
children in good health and intended for use by infants while they are being
weaned, and by young children as a supplement to their diet or for their
progressive adaptation to ordinary food, or both, and divided into the
following four categories—
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(a) simple cereals
which are, or have to be, reconstituted with milk or other appropriate
nutritious liquids,
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(b) cereals with an
added high protein food which are, or have to be, reconstituted with water
or other protein-free liquid,
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(c) pastas which are to
be used after cooking in boiling water or other appropriate liquids, and
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(d) rusks
and biscuits which are to be used either directly, or, after pulverisation,
with the addition of water, milk or other suitable liquids;
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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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“young children” means children aged between 1 and 3 years.
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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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(d) A reference in
these Regulations to an Article is to an Article of the Directive, unless it
is indicated that reference to some other instrument is intended.
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PART 2 General
Provisions
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3. (1)
These Regulations apply to foodstuffs for particular nutritional use
fulfilling the particular requirements of infants and young children in good
health and intended for use by infants while they are being weaned, and by
young children, as a supplement to their diet, or for their progressive
adaptation to ordinary food, or both.
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(2) The
foodstuffs referred to at paragraph (1) comprise processed cereal-based
foods and baby foods.
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(3) These
Regulations shall not apply to milks intended for young children.
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(4) A
person shall not manufacture or place on the market processed cereal-based
foods or baby foods, or products presented as such, unless that person
complies with the provisions laid down in these Regulations and in the
Directive.
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(5)
Agricultural products intended for the production of processed cereal-based
foods or baby foods shall be treated in accordance with the requirements of
these Regulations.
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4. (1)
Processed cereal-based foods and baby foods shall be manufactured from
ingredients whose suitability for particular nutritional use by infants and
young children has been established by generally accepted scientific data.
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(2)
Processed cereal-based foods shall comply with the compositional criteria
specified in Schedule 1.
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(3) Baby
foods which are described in Schedule 2 shall comply with the compositional
criteria specified therein.
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(4) Only
the nutritional substances listed in Schedule 4 may be added in the
manufacture of processed cereal-based foods and baby foods.
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(5)
Processed cereal-based foods and baby foods shall not contain any substance
in such quantity as to endanger the health of infants and young children.
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(6)
Processed cereal-based foods and baby foods shall not contain residues of
individual pesticides at levels exceeding 0.01mg per kg, except for those
substances for which specific levels have been set in Schedule 6, in which
case those specific levels shall apply.
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(7) The
levels referred to at paragraph (6) shall apply to the products as proposed
ready for consumption or as reconstituted according to the instructions of
the manufacturer.
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(8)
Analytical methods for determining the levels of pesticide residues shall be
generally acceptable standardised methods.
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(9) Those
pesticides listed in Schedule 7 shall not be used in agricultural products
intended for the production of processed cereal-based foods and baby foods.
However, for the purpose of control, pesticides listed in Tables 1 and 2 of
Schedule 7 are considered not to have been used if their residues do not
exceed a level of 0.003mg per kg.
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(10) The
levels referred to in paragraph (9) shall apply to the products as proposed
ready for consumption or as reconstituted according to the instructions of
the manufacturers.
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5. (1) The
labelling of processed cereal-based foods and baby foods shall bear in
addition to the particulars provided for in Article 3 of Directive
2000/13/EC 5 of the European
Parliament and of the Council of 20 March 2000 on the approximation of the
laws of the Member States relating to the labelling, presentation and
advertising of foodstuffs, the following mandatory particulars—
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(a) a statement as to
the appropriate age from which the product may be used, with regard to its
composition, texture or other particular properties. The stated age shall
not be less than 4 months for any product. Products recommended for use from
the age of 4 months may indicate that they are suitable from that age unless
independent persons having qualifications in medicine, nutrition or
pharmacy, or other professionals responsible for maternal and child care,
advise otherwise,
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(b) information as to
the presence or absence of gluten if the indicated age from which the
product may be used is below 6 months,
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(c) the available
energy value expressed in kJ and kcal, and the protein, carbohydrate and
lipid content, expressed in numerical form, per 100g or 100ml of the product
as sold and, where appropriate, per specified quantity of the product as
proposed for consumption,
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(d) the average
quantity of each mineral substance and of each vitamin governed by a
specific level as specified in Schedules 1 and 2 respectively, expressed in
numerical form, per 100g or 100ml of the product as sold and, where
appropriate, per specified quantity of the product as proposed for
consumption, and
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(e) instructions for
appropriate preparation, when necessary, and a statement as to the
importance of following those instructions.
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(2) The
labelling of processed cereal-based foods and baby foods may bear—
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(a) the average
quantity of the nutrients set out in Schedule 4 when such declaration is not
covered by the provisions of paragraph (1)(d), expressed in numerical
form, per 100g or 100ml of the product as sold and, where appropriate, per
specified quantity of the product as proposed for consumption, and
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(b) in addition to
numerical information, information on vitamins and minerals shown in
Schedule 5, expressed as a percentage of the reference values given therein,
per 100g or 100ml of the product as sold, and where appropriate, per
specified quantity of the product as proposed for consumption, provided that
the quantities present are at least equal to 15% of the reference values.
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PART 3
Enforcement
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6. (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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7. (1) An
authorised officer may, for the purposes of these Regulations, purchase or
take without payment a sample of processed cereal-based foods, baby foods or
other relevant substance.
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(2) An
authorised officer may, for the purpose of taking a sample of processed
cereal-based foods, baby foods or other relevant substance, open any
receptacle.
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(3) Where
an authorised officer purchases or takes without payment a sample of
processed cereal-based foods, baby foods 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 processed cereal-based foods, baby
foods or other relevant 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 processed cereal-based foods or baby
foods 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 processed cereal-based foods or baby foods or other
relevant substance, prohibit the removal of the processed cereal-based
foods, baby foods or other relevant substance 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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8. (1)
Where a sample of processed cereal-based foods, baby foods 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 not
more than 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 processed cereal based
foods, baby foods 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 processed cereal-based
foods, baby foods 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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9. (1) The
approved examiner or a person under his or her direction shall analyse as
soon as possible any sample of processed cereal-based foods, baby foods 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 8 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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10. Where a
sample of processed cereal-based foods, baby foods 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 9 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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11. An
authorised officer may, for the purposes of these Regulations, inspect and
take copies, or samples, of labels used on processed cereal-based foods,
baby foods or other relevant substance.
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12. The
provisions of Regulations 7, 8, 9, 10 and 11 shall also apply in respect of—
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(a) products which are
not baby foods or processed cereal-based foods, 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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13. (1) An
authorised officer may, for the purposes of these Regulations, seize,
remove, detain or direct the withdrawal from the market of any processed
cereal-based foods, baby foods 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 processed
cereal-based foods, baby foods 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 processed cereal-based foods, baby foods 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 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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14. 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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15. 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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16. (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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17. 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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18. (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 in this Regulation 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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19. (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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20.
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
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or both.
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PART 4 Revocation
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21. (1) The
European Communities (Processed Cereal-Based Foods and Baby Foods for
Infants and Young Children) Regulations 2004 ( S.I. No. 433 of 2004 ) 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 PROCESSED CEREAL-BASED FOODS FOR INFANTS AND YOUNG
CHILDREN
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The requirements concerning nutrients refer to
the products ready for use marketed as such or reconstituted as instructed
by the manufacturer.
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1. Cereal Content
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Processed cereal-based foods are prepared primarily from one or more
milled cereals and/or starchy root products.
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The amount of cereal and/or starchy root shall not be less than 25% of
the final mixture on a dry weight for weight basis.
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2. Protein
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2.1 For products mentioned in
Article 1(2)(a)(ii) and (iv), the protein content shall not exceed
1.3g/100 kJ (5.5g/100 kcal).
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2.2 For products mentioned in
Article 1(2)(a)(ii), the added protein shall not be less than
0.48g/100 kJ (2g/100 kcal).
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2.3 For biscuits mentioned in
Article 1(2)(a)(ii) and (iv), made with the addition of a high
protein food, and presented as such, the added protein shall not be less
than 0.36g/100 kJ (1.5g/100 kcal).
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2.4 The chemical index of the
added protein shall be equal to at least 80% of that of the reference
protein (casein as defined in Schedule 3), or the protein efficiency ratio
(PER) of the protein in the mixture shall be equal to at least 70% of that
of the reference protein. In all cases, the addition of amino acids shall be
permitted solely for the purpose of improving the nutritional value of the
protein mixture, and only in the proportions necessary for that purpose.
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3. Carbohydrates
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3.1 If sucrose, fructose,
glucose, glucose syrups or honey are added to products mentioned in Article
1(2)(a)(i) and (iv):
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—the amount of added carbohydrates from these
sources shall not exceed 1.8g/100 kJ (7.5g/100 kcal).
|
|
|
|
—the amount of added fructose shall not exceed
0.9g/100 kJ (3.75g/100 kcal).
|
|
|
|
3.2 If sucrose, fructose,
glucose syrups or honey are added to products mentioned in Article 1(2)(a)(ii):
|
|
|
|
—the amount of added carbohydrates from these
sources shall not exceed 1.2g/100 kJ (5g/100 kcal).
|
|
|
|
—the amount of added fructose shall not exceed
0.6g/100 kJ (2.5g/100 kcal).
|
|
|
|
4. Lipids
|
|
|
|
4.1 For products mentioned in
Article 1(2)(a)(i) and (iv): the lipid
content shall not exceed 0.8g/100 kJ (3.3g/100 kcal).
|
|
|
|
4.2 For products mentioned in
Article 1(2)(a)(ii): the lipid content shall not exceed 1.1g/100 kJ
(4.5g/100 kcal). If the lipid content exceeds 0.8g/100 kJ (3.3g/100 kcal):
|
|
|
|
—the amount of lauric
acid shall not exceed 15% of the total lipid content,
|
|
|
|
—the amount of myristic
acid shall not exceed 15% of the total lipid content,
|
|
|
|
—the amount of linoleic
acid (in the form of glycerides = linoleates) shall not be less than 70mg/100 kJ
(300mg/100 kcal) and shall not exceed 285mg/100 kJ (1200mg/100 kcal).
|
|
|
|
5. Minerals
|
|
|
|
5.1 Sodium
|
|
|
|
—Sodium salts may only be added to processed
cereal-based foods for technological purposes,
|
|
|
|
—the sodium content of processed cereal-based
foods shall not exceed 25mg/100 kJ (100mg/100 kcal).
|
|
|
|
5.2. Calcium
|
|
|
|
5.2.1 For products mentioned
in Article 1(2)(a)(ii), the amount of calcium shall not be less than
20mg/100 kJ (80mg/100 kcal).
|
|
|
|
5.2.2 For products mentioned
in, Article 1(2)(a) and (iv), manufactured with the addition of milk
(milk biscuits) and presented as such, the amount of calcium shall not be
less than 12mg/100 kJ (50mg/100 kcal).
|
|
|
|
6. Vitamins
|
|
|
|
6.1 For processed cereal-based
foods, the amount of thiamin shall not be less
than 25g/100 kJ (100g/100 kcal).
|
|
|
|
6.2 For products mentioned in
Article 1(2)(a)(ii):
|
|
|
|
|
|
|
Per 100 kJ
|
|
Per 100 kcal
|
|
|
Minimum
|
Maximum
|
Minimum
|
Maximum
|
|
Vitamin A (g RE) ( 1 )
|
14
|
43
|
60
|
180
|
|
Vitamin D (g) ( 2 )
|
0.25
|
0.75
|
1
|
3
|
|
(1) RE = all trans retinol equivalents
|
|
(2) In the form of cholecalciferol, of which
10g = 400 i.u. of vitamin D.
|
|
|
|
|
These limits shall be applicable if vitamins A and D are added to other
processed cereal-based foods.
|
|
|
|
7. Maximum limits for
vitamins, minerals and trace elements, if added
|
|
|
|
The requirements concerning
nutrients refer to the products ready for use, marketed as such or
reconstituted as instructed by the manufacturer, except for potassium and
calcium for which the requirements refer to the product as sold.
|
|
|
|
|
Nutrient
|
Maximum per 100 kcal
|
|
Vitamin A (g RE)Vitamin E (mg a —TE)( 1 )Vitamin D (g)Vitamin C (mg)Thiamin (mg)Riboflavin (mg)Niacin (mg NE)Vitamin B6
(mg)( 3 )Folic acid (g)Vitamin B12 (g) Pantothenic
acid (mg)Biotin (g)Potassium (mg)Calcium (mg)Magnesium (mg)Iron (mg)Zinc
(mg)Copper (g)Iodine (g)Manganese (mg)
|
1803312.5/25 ( 2 )0.50.44.50.35500.351.51016080/180 ( 4 )/100 ( 5
)403240350.6
|
|
|
|
|
( 1 ) -TE = d--tocopherol equivalent.
|
|
|
|
( 2 ) Limit applicable to products fortified with iron.
|
|
|
|
( 3 ) NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60.
|
|
|
|
( 4 ) Limit applicable to products mentioned in Article 1(2)(a)(i) and (ii).
|
|
|
|
( 5 ) Limit applicable to products mentioned in Article 1(2)(a)(iv).
|
|
|
|
SCHEDULE 2
ESSENTIAL COMPOSITION OF BABY FOODS FOR INFANTS AND YOUNG CHILDREN
|
|
|
|
The requirements concerning
nutrients refer to the products ready for use, marketed as such or
reconstituted as instructed by the manufacturer.
|
|
|
|
1. Protein
|
|
|
|
1.1 If meat, poultry, fish,
offal or other traditional source of protein, are the only ingredients
mentioned in the name of the product, then:
|
|
|
|
—the named meat, poultry, fish, offal or other
traditional protein source, in total, shall constitute not less than 40% by
weight of the total product,
|
|
|
|
—each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less than 25%, by weight,
of total named protein sources,
|
|
|
|
—the total protein from the named sources shall
not be less than 1.7g/100 kJ (7g/100 kcal).
|
|
|
|
1.2 If meat, poultry, fish,
offal or other traditional source of protein, singularly or in combination,
are mentioned first in the name of the product, whether or not the product
is presented as a meal, then:
|
|
|
|
—the named meat, poultry, fish, offal or other
traditional protein source, in total, shall constitute not less than 10% by
weight of the total product,
|
|
|
|
—each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less than 25% by weight,
of total named protein sources,
|
|
|
|
—the protein from the named sources shall not be
less than 1g/100 kJ (4g /100 kcal).
|
|
|
|
1.3 If meat, poultry, fish,
offal or other traditional source of protein singularly or in combination
are mentioned, but not first, in the name of the product, whether or not the
product is presented as a meal, then:
|
|
|
|
—the named meat, poultry, fish, offal or other
traditional protein source, in total, shall constitute not less than 8% by
weight of the total product,
|
|
|
|
—each named meat, poultry, fish, offal or other
traditional source of protein shall constitute not less than 25%, by weight,
of total named protein sources,
|
|
|
|
—the protein from the named sources shall not be
less than 0.5g/100 kJ (2.2g/100 kcal),
|
|
|
|
—the total protein in the product from all
sources shall not be less than 0.7g/100 kJ (3g/100 kcal).
|
|
|
|
1.4 If cheese is mentioned
together with other ingredients in the name of a savoury product, whether or
not the product is presented as a meal, then:
|
|
|
|
—the protein from the dairy sources shall not be
less than 0.5g/100kJ (2.2g/100 kcal)
|
|
|
|
—the total protein in the product from all
sources shall not be less than 0.7g/100kJ (3g/100 kcal)
|
|
|
|
1.5 If the product is
designated on the label as a meal, but does not mention meat, poultry, fish,
offal or other traditional source of protein in the name of the product, the
total protein in the product from all sources shall not be less than
0.7g/100 kJ (3g/100 kcal).
|
|
|
|
1.6 Sauces presented as an
accompaniment to a meal shall be exempt from the requirements of points 1.1
to 1.5 inclusive.
|
|
|
|
1.7 Sweet dishes that mention
dairy products as the first or only ingredient in the name shall contain not
less than 2.2g dairy protein/100 kcal. All other sweet dishes shall be
exempt from the requirements in 1.1 to 1.5.
|
|
|
|
1.8 The addition of amino
acids shall be permitted solely for the purpose of improving the nutritional
value of the protein present, and only in the proportions necessary for that
purpose.
|
|
|
|
2. Carbohydrates
|
|
|
|
The quantities of total carbohydrates present in fruit and vegetable
juices and nectars, fruit-only dishes, and desserts or puddings shall not
exceed:
|
|
|
|
—10g/100ml for vegetable juices and drinks based
on them,
|
|
|
|
—15g/100ml for fruit juices and nectars and
drinks based on them,
|
|
|
|
—20g/100g for fruit-only dishes,
|
|
|
|
—25g/100g for desserts and puddings,
|
|
|
|
—5g/100g for other non-milk-based drinks.
|
|
|
|
3. Fat
|
|
|
|
3.1 For products referred to
in point 1.1:
|
|
|
|
if meat or cheese are the only ingredients or are mentioned first in the
name of a product, the total fat in the product from all sources shall not
exceed 1.4g/100 kJ (6g/100 kcal).
|
|
|
|
3.2 For all other products,
the total fat in the product from all sources shall not exceed 1.1g/100 kJ
(4.5g/100 kcal).
|
|
|
|
4. Sodium
|
|
|
|
4.1 The final sodium content
in the product shall be either not more than 48mg/100 kJ (200mg/100 kcal) or
not more than 200mg per 100g. However, if cheese is the only ingredient
mentioned in the name of the product, the final sodium content in the
product shall not be more than 70mg/100 kJ (300mg/100 kcal).
|
|
|
|
4.2 Sodium salts may not be
added to products based on fruit, nor to desserts, puddings except for
technological purposes.
|
|
|
|
5. Vitamins
|
|
|
|
Vitamin C
|
|
|
|
In a fruit juice, nectar, or vegetable juice the final content of vitamin
C in the product shall be either not less than 6mg/100 kJ (25mg/100 kcal) or
not less than 25mg per 100g.
|
|
|
|
Vitamin A
|
|
|
|
In vegetable juices, the final content of vitamin A in the product shall
be not less than 25g RE/100 kJ (100g RE/100 kcal).
|
|
|
|
Vitamin A shall not be added to other baby foods.
|
|
|
|
Vitamin D
|
|
|
|
Vitamin D shall not be added to baby foods.
|
|
|
|
6. Maximum limits for
vitamins, minerals and trace elements, if added
|
|
|
|
The requirements concerning nutrients refer to the products ready for
use, marketed as such or reconstituted as instructed by the manufacturer,
except for potassium and calcium for which the requirements refer to the
product as sold.
|
|
|
|
|
Nutrient
|
Maximum per 100 kcal
|
|
Vitamin A (g RE)Vitamin E (mg a —TE)Vitamin C (mg)Thiamin
(mg)Riboflavin (mg)Niacin (mg NE)Vitamin B6 (mg)Folic acid (g)Vitamin B12
(g) Pantothenic acid (mg)Biotin (g)Potassium
(mg)Calcium (mg)Magnesium (mg)Iron (mg)Zinc (mg)Copper (g)Iodine
(g)Manganese (mg)
|
180( 1 )312.5/25 ( 2 )/125( 3
)0.250.44.50.35500.351.51016080403240350.6
|
|
|
|
|
( 1 ) In accordance with the
provisions of point 5.
|
|
|
|
( 2 ) Limit applicable to
products fortified with iron.
|
|
|
|
( 3 ) Limit applicable to
fruit-based dishes, fruit juices, nectars and vegetable juices.
|
|
|
|
SCHEDULE 3 AMINO
ACID COMPOSITION OF CASEIN
|
|
|
|
(g) per 100 g of protein)
|
|
|
|
|
Arginine
|
3.7
|
|
Cystine
|
0.3
|
|
Histidine
|
2.9
|
|
Isoleucine
|
5.4
|
|
Leucine
|
9.5
|
|
Lysine
|
8.1
|
|
Methionine
|
2.8
|
|
Phenylalanine
|
5.2
|
|
Threonine
|
4.7
|
|
Tryptophan
|
1.6
|
|
Tyrosine
|
5.8
|
|
Valine
|
6.7
|
|
|
|
|
SCHEDULE 4
NUTRITIONAL SUBSTANCES
|
|
|
|
1. Vitamins
|
|
|
|
Vitamin A
|
|
|
|
Retinol
|
|
|
|
Retinyl acetate
|
|
|
|
Retinyl palmitate
|
|
|
|
beta carotene
|
|
|
|
Vitamin D
|
|
|
|
Vitamin D2 (= ergocalciferol)
|
|
|
|
Vitamin D3 (= cholecalciferol)
|
|
|
|
Vitamin B1
|
|
|
|
Thiamin hydrochloride
|
|
|
|
Thiamin mononitrate
|
|
|
|
Vitamin B2
|
|
|
|
Riboflavin
|
|
|
|
Riboflavin-5’-phosphate, sodium
|
|
|
|
Niacin
|
|
|
|
Nicotinamide
|
|
|
|
Nicotinic acid
|
|
|
|
Vitamin B6
|
|
|
|
Pyridoxine hydrochloride
|
|
|
|
Pyridoxine-5-phosphate
|
|
|
|
Pyridoxine dipalmitate
|
|
|
|
Pantothenic Acid
|
|
|
|
D-pantothenate, calcium
|
|
|
|
D-pantothenate, sodium
|
|
|
|
Dexpanthenol
|
|
|
|
Folate
|
|
|
|
Folic acid
|
|
|
|
Vitamin B12
|
|
|
|
Cyanocobalamin
|
|
|
|
Hydroxocobalamin
|
|
|
|
Biotin
|
|
|
|
D-biotin
|
|
|
|
Vitamin C
|
|
|
|
L-Ascorbic acid
|
|
|
|
Sodium L-ascorbate
|
|
|
|
Calcium L-ascorbate
|
|
|
|
6-Palmityl-L-ascorbic acid (ascorbyl palmitate)
|
|
|
|
potassium ascorbate
|
|
|
|
Vitamin K
|
|
|
|
Phylloquinone (Phytomenadione)
|
|
|
|
Vitamin E
|
|
|
|
D-alpha tocopherol
|
|
|
|
DL-alpha tocopherol
|
|
|
|
D-alpha tocopherol acetate
|
|
|
|
DL-alpha tocopherol acetate
|
|
|
|
2. Amino acids
|
|
|
|
L-arginine)
|
|
|
|
L-cystine)
|
|
|
|
L-histidine)
|
|
|
|
L-isoleucine)and their hydrochlorides
|
|
|
|
L-leucine)
|
|
|
|
L-lysine)
|
|
|
|
L-cysteine)
|
|
|
|
L-methionine
|
|
|
|
L-phenylalanine
|
|
|
|
L-threonine
|
|
|
|
L-tryptophan
|
|
|
|
L-tyrosine
|
|
|
|
L-valine
|
|
|
|
3. Others
|
|
|
|
Choline
|
|
|
|
Choline chloride
|
|
|
|
Choline citrate
|
|
|
|
Choline bitartrate
|
|
|
|
Inositol
|
|
|
|
L-Carnitine
|
|
|
|
L-carnitine hydrochloride
|
|
|
|
4. Salts of minerals and
trace elements
|
|
|
|
Calcium
|
|
|
|
Calcium carbonate
|
|
|
|
Calcium chloride
|
|
|
|
Calcium salts of citric acid
|
|
|
|
Calcium gluconate
|
|
|
|
Calcium glycerophosphate
|
|
|
|
Calcium lactate
|
|
|
|
Calcium oxide
|
|
|
|
Calcium hydroxide
|
|
|
|
Calcium salts of orthophosphoric acid
|
|
|
|
Magnesium
|
|
|
|
Magnesium carbonate
|
|
|
|
Magnesium chloride
|
|
|
|
Magnesium salts of citric acid
|
|
|
|
Magnesium gluconate
|
|
|
|
Magnesium oxide
|
|
|
|
Magnesium hydroxide
|
|
|
|
Magnesium salts of orthophosphoric acid
|
|
|
|
Magnesium sulphate
|
|
|
|
Magnesium lactate
|
|
|
|
Magnesium glycerophosphate
|
|
|
|
Potassium
|
|
|
|
Potassium chloride
|
|
|
|
Potassium salts of citric acid
|
|
|
|
Potassium gluconate
|
|
|
|
Potassium lactate
|
|
|
|
Potassium glycerophosphate
|
|
|
|
Iron
|
|
|
|
Ferrous citrate
|
|
|
|
Ferric ammonium citrate
|
|
|
|
Ferrous gluconate
|
|
|
|
Ferrous lactate
|
|
|
|
Ferrous sulphate
|
|
|
|
Ferrous fumarate
|
|
|
|
Ferric diphosphate (Ferric pyrophosphate)
|
|
|
|
Elemental iron (carbonyl + electrolytic + hydrogen-reduced)
|
|
|
|
Ferric saccharate
|
|
|
|
Sodium ferric diphosphate
|
|
|
|
Ferrous carbonate
|
|
|
|
Copper
|
|
|
|
Copper-lysine complex
|
|
|
|
Cupric carbonate
|
|
|
|
Cupric citrate
|
|
|
|
Cupric gluconate
|
|
|
|
Cupric sulphate
|
|
|
|
Zinc
|
|
|
|
Zinc acetate
|
|
|
|
Zinc chloride
|
|
|
|
Zinc citrate
|
|
|
|
Zinc lactate
|
|
|
|
Zinc sulphate
|
|
|
|
Zinc oxide
|
|
|
|
Zinc gluconate
|
|
|
|
Manganese
|
|
|
|
Manganese carbonate
|
|
|
|
Manganese chloride
|
|
|
|
Manganese citrate
|
|
|
|
Manganese gluconate
|
|
|
|
Manganese sulphate
|
|
|
|
Manganese glycerophosphate
|
|
|
|
Iodine
|
|
|
|
Sodium iodide
|
|
|
|
Potassium iodide
|
|
|
|
Potassium iodate
|
|
|
|
Sodium iodate
|
|
|
|
SCHEDULE 5
REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND
YOUNG CHILDREN
|
|
|
|
|
Nutrient
|
Labelling Reference Value
|
|
Vitamin AVitamin DVitamin
CThiaminRiboflavinNiacin equivalentsVitamin
B6FolateVitamin B12CalciumIronZincIodineSeleniumCopper
|
(g) 400(g) 10(mg) 25(mg) 0.5(mg) 0.8(mg) 9(mg) 0.7(g) 100(g) 0.7(mg)
400(mg) 6(mg) 4(g) 70(g) 10(mg) 0.4
|
|
|
|
|
SCHEDULE 6
SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES
IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS
|
|
|
|
|
Chemical name of the substance
|
Maximum residuelevel (mg/kg)
|
|
Cadusafos
|
0.006
|
|
Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined,
expressed as demeton-S-methyl)
|
0.006
|
|
Ethoprophos
|
0.008
|
|
Fipronil (sum of fipronil
and fipronil-desulfinyl, expressed as fipronil)
|
0.004
|
|
Propineb/propylenethiourea (sum of propineb and propylenethiourea)
|
0.006
|
|
|
|
|
SCHEDULE 7
PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR
THE PRODUCTION OF PROCESSED CEREAL-BASED FOODS AND BABY FOODS
|
|
|
|
Table 1
|
|
|
|
|
Chemical name of the substance (residue definition)
|
|
Disulfoton (sum of disulfoton,
disulfoton sulfoxide
and disulfoton sulfone
expressed as disulfoton)
|
|
Fensulfothion (sum of fensulfothion,
its oxygen analogue and their sulfones,
expressed as fensulfothion)
|
|
Fentin, expressed as triphenyltin
cation
|
|
Haloxyfop (sum of haloxyfop,
its salts and esters including conjugates, expressed as haloxyfop)
|
|
Heptachlor and trans-heptachlor epoxide,
expressed as heptachlor
|
|
Hexachlorobenzene
|
|
Nitrofen
|
|
Omethoate
|
|
Terbufos (sum of terbufos,
its sulfoxide and sulfone,
expressed as terbufos)
|
|
|
|
|
Table 2
|
|
|
|
|
Chemical name of the substance
|
|
Aldrin and dieldrin,
expressed as dieldrin
|
|
Endrin
|
|
|
|
|
SCHEDULE 8
|
|
|
|
Form of offical
certificate to be given by an approved examiner to an authorised officer.
|
|
|
|
EUROPEAN
COMMUNITIES (PROCESSED CEREAL-BASED FOODS AND BABY FOODS FOR INFANTS AND
YOUNG CHILDREN) REGULATIONS 2007
|
|
|
|
Certificate of
Analysis
|
|
|
|
To (1)
..............................
|
|
|
|
I, the undersigned (2)
................................................
|
|
|
|
being an approved examiner
for the purpose of the above Regulations certify that on
|
|
|
|
the
................................ day of ..................................
20........
|
|
|
|
a sample marked (3)
.........................................
|
|
|
|
Date
................................................
|
|
|
|
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
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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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28 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 effect to Commission
Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and
baby foods for infants and young children.
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These Regulations revoke the European
Communities (Processed Cereal-Based Foods and Baby Foods for Infants and
Young Children) Regulations 2004 ( S.I. No. 433 of 2004 ).
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These Regulations may be cited as the European
Communities (Processed Cereal-Based Foods and Baby Foods for Infants and
Young Children) Regulations 2007.
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1 OJ L 339,
6.12.2006, p. 16.
2 OJ L 31,
1.2.2002, p. 1.
3 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.
4 OJ L 230,
19.8.1991, p. 1.
5 OJ L 109,
6.5.2000, p. 29.
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