Infant Foods Foods... · 2020-05-30 · from protein hydrolysates Commission Directive 2006/141/EC....

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


Introduction

Legal framework


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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Introduction

Legal framework


Labelling


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


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


Introduction

Legal framework


Labelling


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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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Introduction

Legal framework


Labelling


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.


Introduction

Legal framework


Labelling


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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


Labelling

Residues, Microbiological and contaminantstandards

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Dr Andy Bowles

[email protected]

www.abcfoodlaw.co.uk@abcfoodlaw

01603 319863

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Infant formula &

follow on

Regulation 127

Processed cereal-based

foods

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Compositional Requirements for mf.vit formula

Composibonal Requirements !Of follow on fomiula

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Infant Foods Foods... · 2020-05-30 · from protein hydrolysates Commission Directive 2006/141/EC....

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Transcript of Infant Foods Foods... · 2020-05-30 · from protein hydrolysates Commission Directive 2006/141/EC....