food regulations on confectionery products

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    Foo d Regu la t ion

    onCon fect i oner y Pr odu ct s i n I n d ia

    ( Chew ing Gu m , Bub b le Gum , Su gar an d Sug ar f r ee

    Con fec t ion er y , Cocoa and Cocoa Pr od u ct s)

    Sh a sh i B M ish r a

    Fo o d w o r l d I n d i a- 2 0 1 1 M u m b a i 1 7 t h N ovember1

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    Introduction

    Overview of current FSSAI Standards - impact on industry

    Benefits of harmonizing Indian Food Laws with Codex and

    other International Standards

    Specific areas to consider:

    Removal of Vertical standards

    Food Additives (Sweeteners, Talc and other additives)

    General recommendations for gum and confectionery products

    QA& Discussion

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    Introduction

    Food sector is one of the most rapidly evolving sectors in Indiaand in the world. The market size of confectionery in India is estimated at

    US$ 1 12 7 m i l l i on & growing at the rate of11 .9 % perannum

    Market Forecast to have value ofUS$2005m i l l i on by 2014(Source: Datamonitor Sept-2010 report).

    Food safety and consumer protection is becoming increasingly

    important owing to advancement of food science.

    There is requirement for a regulatory regime which facilitatesnovel, nutritious and healthy product development while at thesame time protecting consumers health.

    PFA enacted in 1955, with > 200 amendments to date.

    Modernizing and harmonizing Indian food regulations is

    important for Indian industrys future growth and internationaltrade.

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    CurrentFSSAIStandards

    Emphasis on vertical compositional standards (finished

    products)

    Chewing gum and Bubble gum are regulated as Reg

    2.7.3 in FSSAI 1st Aug 2011

    Other confectionery is regulated Under Reg.2.7.1:

    Sugar Boiled Confectionery; Reg 2.7.2: Lozenges

    Parameters in existing standards are overly restrictive to

    Innovation and are generally unique to India.

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    Ver t i ca l St and ar dsCurrent Chewing gum and Bubble gum standards

    Par am et er Ch ew in ggu m

    Bubb leg u m

    Gum content, Min., percent by wt. 12.5 14

    Moisture, Max., percent by wt 3.5 3.5

    Sulphated ash, Max., percent by wt. 9.5 11.5

    Acid insoluble ash, Max., percent by wt. 2.0 3.5

    Reducing sugar calculated as dextrose,Min., percent by wt. 4.5 5.5

    Sucrose, Max., percent by wt. 70 60

    CurrentFSSAIStandards

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    Existing standards are not comprehensive - manyfinished products do not fall into any of the currentvertical standards: Example: Center filled gum

    SPOUTCENTERFRESHDOUBLEMINTSPLASH

    A Pr op r ie ta ryProduc t

    BUBBALOO

    CurrentFSSAIStandards

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    Few add i t i ves a re i ncl uded i n ex i st i ng st anda rds many globally approved additives used in gums andconfectionery are not approved in current standards

    Cer t a in st anda rds - Con f l i ct i ng and con t rad i ct o r y

    Ex am ple NO -1

    As per (*GSR. 184E), usage of Acidulants in chewing gumand bubble gum was omitted from main ingredients list andput to the Table 13(G).However, regulation 3.1.12 allowsdifferent limits of acidulants for miscellaneous foods. E.g. innew table 13(G) L(+)Lactic acid is not incorporated, while in

    regulation 3.1.12 L(+)Lactic acid is allows as As Acidulant inmiscellaneous foods at GMP* level and Miscellaneous foodis not specifically defined (grey area).

    Affect: Both the above rules contradicts each other, therefore

    which rule is to be followed, although the ingredient is thesame.

    CurrentFSSAIStandards

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    Ex am ple No.2

    As per latest notification amendments of (*GSR. 184E),GLYCERI N is now in the category of lubricants and earlier itwas allowed as the main ingredients of Bubble gum Chewing

    gum. As per new amendment of Food safety and standards(packaging and labeling ) Regulation 2.2.2 (5), we write it asHumectants because there is no category of lubricants forlabeling. What should be its class title?

    Affect:-we are declaring glycerin, as humectants, which is not theclass title of glycerin.

    CurrentFSSAIStandards

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    Suga r Bo i led / Suga r Free

    con fec t i one ry

    Ch ew in g g u m / b u bb le gu m

    Enzy m es, , edib lefood g ra ins & ed ib leseeds and pr o te iniso la tes are a l low edat GMP level

    Enzy m es, , edib lefood g ra ins & ed ib leseeds and pr o te iniso la tes are a l low ed

    at GMP level

    A l l t y pe o f ed ib les tarches a l lowed

    for Sugarb o i le d / Su g a r f r e econ fect i onery asGMP

    Al l t y pe o f ed ib les tarches a l lowed

    for Sugarb o i le d / Su g a r f r e econ fect i onery asGMP

    Sod ium b i carbona tei s al l ow ed fo r sugarb o i le d / su g ar f r e econ fect i onery andlozeng es at GMPleve l .

    Sod ium b i carbona tei s al l ow ed fo r sugarb o i le d / su g ar f r e econ fect i onery andlozeng es at GMPleve l .

    Enzym es, bak in gpow der , ed ib lefood g ra ins &edib le seeds andpro t e in i so latesare NOTALLOWED.

    Enzym es, bak in gpow der , ed ib lefood g ra ins &edib le seeds andpro t e in i so lates

    ar e NOTALLOWED.

    Only Modi f ied

    Star ch @ 0.5%l im i t ed f o rCh e w i n g g u m a n dBubb le gum .

    Only Modi f iedStar ch @ 0.5%l im i t ed f o rCh e w i n g g u m a n dBubb le gum .

    Sodiumbicarbonat e i s nota l low ed fo rch ew i n g g u m a n db u b b l e g u m .

    Sodiumbicarbonat e i s n ota l l owed f orch ew i n g g u m a n db u b b l e g u m .

    CurrentFSSAIStandards

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    GlobalRegulatoryFramework

    CODEX Modern additive regulatory frameworks, like CODEX,are based on creation of horizontal standards

    Safety and intake assessments, and establishment ofAcceptable Daily Intakes (ADI) are based onthorough scientific review and consultation by bodies

    of international experts - Joint FAO/WHO ExpertCommittee on Food Additives (JECFA)

    Science-based

    Safety reviewed periodically by JECFA as newinformation becomes available

    Transparency in review process

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    Ingrdients other than gum base are regulatedinternationally within the Codex General Standard for FoodAdditives (Codex Stan 192)

    Food classification in GSFA is hierarchical

    Chewing gum is identified as Food Category 5.3; Hardand soft Candy Under 5.1 and 5.2, respectively, allwithin the broader category Confectionery (5.0)

    GSFA covers many classes offunctional foodadditives, such as colours, sweeteners (HIS, polyols),antioxydants, etc.

    In addition to the specific provisions authorised ineach food category, the Codex GSFA has anAnnex.(Table 3) that allows the use of additives(those judged by JECFA to have no safety concern) in

    accordance with GMP

    GlobalRegulatoryFramework

    CODEX

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    B fi Ali i i h C d d I i l

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    BenefitstoAligningwithCodexandInternational

    Norms

    Recognised International standards, which are accepted by alarge number of export countries and trade partners

    Scientifically sound and independent

    Consistency with other global regulations promotes andfacilitates international trade to ensure Indian companies are

    internationally competitive

    CODEX standards are basis for resolution ofWTO tradedisputes

    Wider choice and better quality of products for consumer:Systems of regulation that allows for industry to develop tothe evolving nature of food and consumer requirements.

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    FOOD ADDI TI VES

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    Sweeteners

    India permits use ofAspar t am e, Acesu l fam e po t assium ,Su cra lo se, Sod iu m Sacch ar in with restrictions for various products;these levels should be aligned with CODEX

    New sweeteners like Neotame, Stevia, Thaumatin, Aspartame-Acesulfame salt and Erythritolneed consideration

    Different sweeteners are suitable for different kinds of product

    Safety of these sweeteners is already established and are permitted byCodex, EU etc.

    Use of these sweeteners would provide better quality products andhealth benefits to Indian consumer (sweeteners are tooth friendly andnon-cariogenic)

    Neo t am e Th au m at in St ev ia Er y t h r i t o l Asp ar t am e-Acesu l fam e sa l t

    Highsweetnesspotency

    Goodcompatibility

    Goodstability

    Synergy

    Longlastingsweetness

    Readilysoluble

    Good qualitysweetness

    Natural

    Good qualitysweetness

    Good stability

    Natural

    Good qualitysweetness

    Good stability

    Synergisticcombination

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    C bi ti Of S t

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    CombinationOfSweeteners Use of combination of Aspartame and Acesulfame potassium permitted

    only for carbonated water, soft drink concentrate and synthetic drinksfor dispensers Combination of sweeteners is not permitted for other food products

    including Confectionery and Chewing gum Use of sweetener blends is permitted globally including EU, US,

    Australia-New Zealand.

    ca r b o n a t e d w a t e r , so f t d r i n kconcen t ra te

    Con fect i one ry and Chew ing gum

    Combination ofSweetenerPermitted

    Combination ofSweetener NotPermitted

    Benef i t s : Var i e t y o f p r oduc ts are poss ib l e , w i th ou t im pact i ng consum er heal th I m p r o ved t ast e Grea t e r st ab i l i t y

    Enh ances sw eet ness w h ich can r educe ove ra l l l eve ls

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    T l (H d t d M i Sili t )

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    Talc(HydratedMagnesiumSilicate)

    Natural compound

    Safety established.

    Functions as a texturizing agent in chewing gum and bubblegum

    Inert and insoluble material

    Does not react adversely with flavours containing fruit acidsunlike Calcium carbonate

    Approved globally at GMP levels (EU, China, Russia, Australia,US, CODEX)

    Typical gums have up to 15% talc India approves only up to2% in gum and 3.5% in bubble gum

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    W i & Ad i St t t

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    Warning&AdvisoryStatements Artificial sweeteners Aspartame, Acesulfame potassium, Sucralose,

    Sodium Saccharine require warning & advisory statements for

    various products Review of warning & advisory statements is required Most countries do not require all of these statements e.g., Not

    recommended for children The proposed rule also would require:

    a warning on product labels if polyols are present: polyols mayhave laxative effect

    no regard to possible intake of polyol in food warning should be restricted to situations where laxation is likely

    from excessive consumption, which will not apply to mostchewing gums

    These statement gives negative signal about sugar free products inspite of having established benefits such as improved dental healthand oral hygiene as confirmed by the FDI World Dental Federation

    CURRENT WARNING & ADVISORY STATEMENTS

    THIS CONTAINS (NAME OF THE SWEETENER)

    NOT RECOMMENDED FOR CHILDREN

    NO SUGAR ADDED IN THE PRODUCT

    NOT FOR PHENYLKETONURICS (IF ASPARTAME IS USED)

    CONTAINS ARTIFICIAL SWEETENER AND FOR CALORIE CONSCIOUS17

    Chewing gum Additives Comparison

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    ChewinggumAdditivesComparison

    Codex Standard FSSAI Status Comments

    Colors

    Sunset yellow FCF 300 mg/kg Permitted at 100pppm Limit should be aligned with Codex

    Carmines 500 mg/kg Not mentioned Should be permitted at Codex levels

    Ponceau 4R (Cochineal red A) 300mg/kg Permitted at 100ppm Limit should be aligned with Codex

    Allura Red AC 300 ppm Not mentioned Should be permitted at Codex levels

    Indigotine/indigo carmine 300 ppm Permitted t 100ppm Limit should be aligned with Codex

    Brilliant blue FCF 300 mg/kg Permitted at 100ppm Limit should be aligned with Codex

    Chlorophylls and Chlorophyllins,Copper Complex 700 ppm

    Chlorophyll permitted at GMP ;Chlorophyllins and Coppercomplex not mentioned

    Chlorophyllins and Copper complex should bepermitted at Codex levels

    Fast green FCF 300 mg/kg Permitted at 100ppm Limit should be aligned with Codex

    Grape Skin Extracts 500 ppm Not mentioned Should be permitted at Codex levels

    Iron Oxides 10.000 ppm Not mentioned Should be permitted at Codex levels

    Source: Codex General Standards for Food Additives, CODEX STAN 192-1995

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    Chewing gum additive comparison

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    ChewinggumadditivecomparisonCodex StandardCodex Standard FSSAI StatusFSSAI Status CommentsComments

    Antioxidant

    Butylated hydroxytoluene400mg/kg Not mentioned

    Should be permitted at Codex levels

    Butylated hydroxyanisole400mg/kg Permitted at 250ppm Limit should be aligned with Codex

    Sequesterant

    Sodium hexameta phosphate3000ppm Not permitted Should be permitted at Codex levels

    Sodium bicarbonate GMP Not permitted Should be permitted at Codex levels

    Source: Codex General Standards for Food Additives, CODEX STAN 192-1995

    In addition few more additives needs consideration, Hydrogenated Vegetable Fat, high MP 75degC needs to be permitted in Gums

    Glazing agent like Carnauba wax, Candellila wax, Bees wax and Shellac which arepermitted for Confectionery products needs to be permitted at GMP levels for chewinggum also

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    CHOCOLATE STANDARDS

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    Ch l t St d d C i (C d FSSAI)

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    ChocolateStandardComparison(Codexvs.FSSAI)

    Codex Standards FSSAI Standards Comments

    Emulsifier

    Acid /alkali/oxidised starches-GMPCODEX Table -3

    Permitted at 5% Need to be permitted atGMP

    Carageenan and its salts GMPCodex table -3

    Permitted under Regulation3.1.6

    Need to be mentioned inChocolate Standard aswell

    Glazing agent

    Carnauba Wax Carnauba Wax - 500ppm Need to be permitted at

    500ppm in alignment withCodex

    Colors

    COCHINEAL RED and ALLURA RED

    Cocoa and chocolate products -300ppm

    NOT PERMITTED Need to be permitted at

    300ppm in alignment withCodex

    Sweeteners

    Cyclamic acids & its Na & Ca Salts -

    500ppm Not Permitted

    Need to be permitted at

    500ppm

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    Ch l t St d d C i (C d FSSAI)

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    Cod ex St an d ar d s FSSAI St an d ar d s Com m en t s

    Anti oxidants

    Butylated hydroxytoluene - 200ppm Not mentioned Need to be permitted at200ppm in alignment withCodex

    OTHERS

    Codex permits usage of 5%Vegetablefat in Chocolates

    FSSAI doesn't permit usage ofVegetable Fat in Chocolates

    Vegetable Fat needs to bepermitted at 5% levels in

    Chocolate

    Acid Insoluble Ash is not Chocolatecharacteristics as per Codex.

    Acid Insoluble Ash - NMT 0.2%in Chocolate

    Acid Insoluble Ash neednot be Chocolatecharacteristics inalignment with Codex

    Ammonium Hydrogen Carbonate(acidity regulators) GMP-

    Ammonium Carbonate GMP Ammonium Carbonate -Need to be permitted atGMP

    Magnesium Oxide (acidity regulators-GMP

    Magnesium Hydroxide GMP Magnesium oxide - Needto be permitted at GMP

    ChocolateStandardComparison(Codexvs.FSSAI)

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    Cocoa Powder Standard comparison (Codex vs. FSSAI)

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    CocoaPowderStandardcomparison(Codexvs.FSSAI)

    Co d ex St an d ar d s FSSAI St an d ar d s Com m en t s

    Mo ist u r e Co n t en t - NMT 7 % m / m No t m en t ion ed Introduce Moisture Content -

    NMT 7%m/m- in line with CodexStandards

    To t al Ash - N MT 1 4 % ( o n m o ist u r e &fa t f r ee bas is)

    Total Ash shall be omitted fromthe standard in line with CodexStandards

    Ash i n s o lu b le i n d i l u t e HCl - NM T

    1 . 0 % ( o n m o i st u r e & f a t f r e e b a si s)

    Acid Insoluble Ash shall be

    omitted from the standard in linewith Codex Standards

    Co co a B u t t e r - ( i ) f o r lo w f a t = N LT1 0 % ( o n m o i s t u r e f r e e b a si s) ( i i ) f o rh i g h fa t = N LT 2 0 % ( o n m o ist u r ef r ee bas is)

    Cocoa Butter content shall beomitted from the standard in linewith Codex Standards

    Un sa po n if i ab l e m a t t e r - N MT 0 .7 % m / mexcep t i n case o f p r ess cocoa bu t t e rw h i ch sh a ll n ot b e m o r e t h an 0 .3 5 % m / m

    Un sa po n if ia bl e M at t e r - n o tm en t ion ed in FSSAI

    Introduce Unsaponifiable matter- NMT 0.7%m/m except in caseof press cocoa butter which shallnot be more than 0.35%m/m -in line with Codex

    I o d i n e V al u e = 3 2 - 4 2 Iodine Value shall be omittedfrom the standard

    M el t i ng Po in t = 2 9 C - 3 4 C Melting point shall be omittedfrom the standard

    Bu t y r o - r e f r a c t o m e t e r r e ad in g a t 4 0 C= 4 0 . 9 - 4 8 .0 / OR Re f r act i v e I n d e x a t4 0 C = 1 .4 5 3 0 - 1 .4 5 8 0

    Butyro-refractometer readingshall be ommitted from thestandard

    Sa p o n i f i ca t i o n Va lu e = 1 8 8 - 2 0 0 Saponification Value shall beomitted from the standard

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    General Recommendations

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    For Sugar Confectionery, lozenges, Chewing gum & Bubble gum

    Vertical standards and compositional requirements to be removed Horizontal controls on additives should be expanded in line with codex & EU

    Combination of sweeteners should be allowed

    Use of aluminum and calcium lakes should be allowed

    To expand the list of permitted additives in line with Codex (JEFCA) and EU. All the Food, Feeds, Fruits and Vegetables and its extracts, Spices,

    Condiments etc are to be permitted at GMP level

    Talc should be permitted at GMP level in Chewing Gum and Bubble Gum

    Certain labelling requirements, specifically use of advisory and warningstatements, need to be reviewed e.g. sweeteners & ployols

    Permission of all color like Allura red, Cochineal red, Anthocyanins etc. in thechocolate should be as per CODEX.

    Statement to be removed from the definition of Chocolate The chocolate shall notcontain any Vegetable fat other than cocoa butter.

    Permission of Vegetable fat for chocolate products up to 5% in line with CODEX.

    General Recommendations

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