Infant Foods
A webinar presented by:
Dr Andy Bowles
Attendee Notes
27/05/2020
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Infant Foods
Dr Andy Bowles
This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues, microbiological and contaminantstandards
This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues,microbiological and contaminantstandards
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Introduction
Infants Children under the age of 12 months
Young children Children aged between 1 and 3 years
Introduction
Infant formulae Food used by infants during the first months of life and
satisfying by themselves thenutritional requirements of suchinfants
until the introduction of appropriatecomplementary feeding
Introduction
Follow-on formulae Food used by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively
diversified diet of such infants
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Introduction
Processed cereal-based foods Food intended for use by infants when they are weaned and by young children as a supplement
to their diet and/or for their progressive adaptation
to ordinary food
Includes …
Processed cereal-based foods Simple cereals
which are or have to be reconstituted with milk or otherappropriate nutritious liquids,
Cereals with an added high protein food which are or have to be reconstituted with water or other
protein-free liquid, Pastas
which are to be used after cooking in boiling water or otherappropriate liquids,
Rusks and biscuits which are to be used either directly or, after pulverisation,
with the addition of water, milk or other suitable liquids;
Introduction ‘baby food’ means food intended to fulfil the particular
requirements of infants in good health while theyare being weaned, and of young children in goodhealth as a supplement to their diet and/or fortheir progressive adaptation to ordinary food, excluding: (i) processed cereal-based food; and (ii) milk-
based drinks and similar products intended for youngchildren;
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This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues, microbiological and contaminantstandards
Legal framework
Transition from Directive to Regulation Old “PARNUTS” Directive 2009/39/EC
New Foods for Specific Groups (FSG) Regulation Regulation 609/2013 Supplementing Regulations
Legal framework
Three separate requirements: Infant formula and follow on Processed cereal-based foods and baby foods for
infants and young children Infant food for special medical purposes
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Legal Framework
Infant formula &follow on
Regulation 127
Food for Specific Groups (Foodfor Special Medical Purposesfor Infants, Infant Formula and
Follow-on Formula) (Informationand Compositional
Requirements) (Amendmentetc.) (England) Regulations
2020
Processedcereal-based
foods
Directive 2006/125
Processed Cereal-based Foodsand Baby Foods for Infants and
Young Children (England)Regulations 2003 (as
amended).
Infant food forspecial medical
purposes
Regulation 128
Food for Specific Groups(Information and Compositional
Requirements) (England)Regulations 2016 (as amended)
Legal framework Infant formula and follow on
Regulation (EU) 609/2013 as supplemented by: Regulation 2016/127 “Regulation 127”.
Composition and labelling for infant formula and follow-on formulaand as regards requirements on information relating to infant andyoung child feeding Food for Specific Groups (Food for Special Medical Purposes for
Infants, Infant Formula and Follow-on Formula) (Information andCompositional Requirements) (Amendment etc.) (England)Regulations 2020
Regulation 2016/128 “Regulation 128” compositional and information requirements for food for special
medical purposes developed to satisfy the nutritional requirements ofinfants. Food for Specific Groups (Information and Compositional
Requirements) (England) Regulations 2016 (as amended)
Legal framework
Processed cereal-based foods and otherbaby foods. Commission Directive 2006/125/EC Processed Cereal-based Foods and Baby Foods for
Infants and Young Children (England) Regulations 2003(as amended).
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Hydrolysates
Hydrolysates are produced by enzymatichydrolysis of proteins, Suitable for babies with allergies
Hydrolysates
Infant and follow-on formula manufacturedfrom protein hydrolysates Commission Directive 2006/141/EC. The Infant and Follow-on Formula (England)
Regulations 2007. From 21 February 2021 Regulation 2016/127.
Specific compositional andinformation requirements for infant
formula etc
Article 1
Placing on the marketArticle 2
Compositional requirements
Article 3Suitability of ingredients
Article 4Requirements on pesticides
Article 5Name of the food
Article 6Specific requirements on
food information
Article 7Specific requirements on the
nutrition declaration
Article 8Nutrition and health claims
on infant formula
Article 9Statements related to lactose
and DHA
Article 10Requirements for promotionand commercial practices for
infant formula
Article 11Requirements on informationrelating to infant and young
children feeding
Delegated Regulation 2016/127(Infant formula and follow on)
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Reg 127 Annexes(Infant formula & follow on)
Annex I Compositional Requirements for infant formulaAnnex II Compositional Requirements for follow on formulaAnnex III Indispensable & conditionally indispensable amino acids in
breast milk.Annex IV Active substances referred to in Article 4(3)Annex V Active substances referred to in Article 4(4)Annex VI Names referred to in Article 5Annex VII Reference Intakes referred to in Article 7 (7)
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Processed Cereal-based Foodsand Baby Foods for Infants and
Young Children (England)Regulations 2003
Regulation 1Title
Regulation 2Interpretation
Regulation 3Exemption
Regulation 4Restrictions on the sale ofprocessed cereal-based
foods and baby foods
Regulation 5General requirements as to
manufacture andcomposition
Regulation 6Added nutritional
substances and nutrients
Regulation 7Pesticide residues
Regulation 8Labelling
Processed Cereal-based Foods & Baby Foods forInfants & Young Children (England) Regulations 2003(as amended)
Processed Cereal-based Foods and Baby Foods forInfants and Young Children (England) Regulations 2003
1 Processed cereal based foods2 Amino acid composition of casein3 Essential composition of baby food4 Nutritional substances5 Maximum levels of vitamins, minerals and trace elements if
added in processed cereal based foods and baby foods.6 Specific max pesticide levels of certain pesticide levels8 Reference levels for nutrition labelling
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9 Modification of the improvement notice provisions of the Act
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Notification
Regulation 609/2013 Requirement to notify the relevant authority when
infant formula are first put on the market in amember state.
Notification forms available .Gov.uk website.
Other relevant legislation
Hygiene Regulation (EC) 852/2004 &
853/2004 Regulation 2073/2005
Food Information Regulation (EU) 1169/2011
General Food Regulation (EC) 178/2002
Materials and articles
This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues, microbiological and contaminantstandards
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Compositional standards
Infant formula – Reg 127 Annex I Follow on formula – Reg 127 Annex II
Processed Cereal-based Foods – Sched 1 Baby food – Sched 3 Processed Cereal-based Foods & Baby Foods for
Infants & Young Children (England) Regulations2003 (as amended)
Suitability of ingredients:
Infant formula and follow on “…shall be demonstrated by the food business
operator through a systematic review of theavailable data relating to the expected benefitsand to safety considerations as well as, wherenecessary, appropriate studies, performedfollowing generally accepted expert guidance onthe design and conduct of such studies”.
Suitability of ingredient
Processed cereal based food and baby food “No processed cereal-based food or baby food
shall be manufactured from any ingredient otherthan those whose suitability for particularnutritional use by infants and young children hasbeen established by generally accepted scientificdata.”
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This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues, microbiological and contaminantstandards
Labelling: Infant formula & follow on
Food Information for Consumers applies Nutrition and health claims shall not be made on infant formula.
Statements “Lactose only”, “Lactose free” “not suitable for infants with galactosaemia”
Labelling: Infant formula & follow on
Label must include all vitamins and minerals set out in Annex 1
(formula) Annex II (follow on) amount of choline, inositol and carnitine (formula)
No requirement to declare salt content May also include the amounts of components of protein,
carbohydrate or fat the whey protein/casein ratio Added ingredients
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Labelling: Processed Cereal-based Foodsand baby food Food Information for Consumers applies In addition a statement as to the appropriate age (which shall
be not less than four months) from which the foodmay be used, regard being had to its composition, texture or other
particular properties; information as to the presence or absence of
gluten if the age stated is less than six months;
Labelling: Processed Cereal-based Foodsand baby food Energy value expressed in kJ and kcal, and
Protein, carbohydrate and fat content, expressed in numerical form, per 100 g or 100 ml of the
food as sold and, where appropriate, per specifiedquantity of the food as proposed for consumption;
Average quantity of minerals and vitamins as specified in Schedule 1 or 3
Appropriate instructions for preparation if preparation of the food is necessary, and a statement as to the importance of following those
instructions.
This webinar will consider
Introduction
Legal framework
Compositional requirements
Labelling
Residues, microbiological and contaminantstandards
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Pesticides
Provisions set out: Infant and follow on formula Article 4, Annexes IV and V
Processed Cereal-based Foods and baby food Regulation 7 Schedule 7
Pesticides: Infant formula & follow on Infant formula and follow-on formula shall not contain residues at levels exceeding 0.01
mg/kg per active substance. shall only be produced from agricultural products for the production of which plant protection products
containing the active substances listed in Annex V havenot been used.
Pesticides: Processed Cereal-based Foodsand baby food Maximum levels specified Schedule 7
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Microbiological standards
Food business operators manufacturing dried infant formulae or dried foods
for special medical purposes intended for infants below six months, which pose a Cronobacter spp. risk shall monitor the processing areas and equipment for
Enterobacteriaceae as part of their sampling scheme Article 5 (2)
Food safety criteria
Process Hygiene Criteria
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Contaminants
Processed cereal-based foods & baby foods for infants & young children Nitrates
: 200 mg NO3/kg Mycotoxins
Aflatoxin B1 0.10 μg/kg Ochratoxin A 0.5 μg/kg Deoxynivalenol 200 μg/kg Zearalenone 20 μg/kg
Metals Lead 0.050 mg/kg Cadmium 0.04 mg/kg Tin 50 mg/kg
Glycidyl fatty acid esters expressed as glycidol Vegetable oils and fats destined for the production of baby food and processed cereal-based
food for infants and young children 500 μg/kg Polycyclic aromatic hydrocarbons 1.0 μg/kg Tropane alkaloids
Atropine, Scopolamine 1.0 μg/kg
Contaminants
Aflatoxin M1 0.025 μg/kg Infant formulae and follow-on formulae, including
infant milk and follow-on milk:
Patulin Apple juice and solid apple products, including
apple compote and apple puree, for infants andyoung children and labelled and sold as such
Contaminants
Lead Infant formulae and follow-on formulae marketed as powder 0.050 mg/kg marketed as liquid 0.010 mg/kg
Drinks for infants and young children labelled andsold as such, marketed as liquids or to be reconstituted following
instructions of the manufacturer including fruit juices to be prepared by infusion or decoction
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Contaminants
Cadmium Infant formulae and follow on-formulae
Tin Canned infant formulae and follow-on formulae
(including infant milk and follow-on milk),excluding dried and powdered products
Arsenic Rice destined for the production of food for infants
and young children
Contaminants
Glycidyl fatty acid esters expressed asglycidol Infant formula, follow-on formula and foods for
special medical purposes intended for infants andyoung children
Dioxins and PCBs Foods for infants and young children
Polycyclic aromatic hydrocarbons Melamine
Permitted additives: Infant formulae
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Permitted additives: Follow on formulae
Food additives: Processed cereal-based foods
Summary
Introduction
Legal framework
Compositional requirements
Labelling
Residues, Microbiological and contaminantstandards
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Infant formula &
follow on
Regulation 127
Processed cereal-based
foods
O,recbYe2006l125
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purposes
Regulation 128
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Reg 127 Annexes (Infant formula & follow on)
Annex m
Annex N
Annex V
Annex VI
Annex VII
Compositional Requirements for mf.vit formula
Composibonal Requirements !Of follow on fomiula
Indispensable & conditionally indispensable amino ecds in breast milk
Active substances referred to In Article 4(3)
Active substances referred to in Article 4(4)
Names referred tom Miele 5
Reference Intakes referred to in Article 7 {7)
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Processed Cereal-based Foods & Baby Foods for
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(as amended)
Processed Cereal-based roods and Baby Foods for
Infants and Young Chiklrcn (England) Regulations 2003
1 Processed cereal based foods
2 Ammo acid composition of casein
a Essential oompos1tlon of baby food
• _J Nutribonal substances
s Maximum levels of v1tamms, minerals and trace elemenlS 11 added in processed cereal based foods and baby foods.
6 Specific max pesticide levels of certain pesticide levels
8 Reference levels for nutnbon labelling
9 Modtli<:abon of the improvement notice prcvrsrcns of the Act I
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Pesticides: Processed Cereal-based Foods
and baby food
• Maximum levels specified Schedule 7
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