The relationships betweenCodex StandardsandEuropean, nationalFood safety and labelling RegulationsDario Dongo © 2013Food l...
Premise• The Codex Alimentarius Commission (FAO & WHO, 1963)was builtwith the aim of protecting consumers’ health,by means...
Codex & WTO, SPS Agreement• Under the SPS agreement, WTO, Codex provides worlwidecriteria for risk assessment (RA)Since th...
SPS, exceptions• WTO members can adopt temporary SPS measureswhere the relevant scientific evidence is insufficient*Althou...
Codex Alimentarius & EU• The EC has EXCLUSIVE COMPETENCE for matters on which the ruleshave already been harmonised – full...
Codex – EU, common groundsFood, notion‘Food’ means any substance,whether processed, semi-processedor raw, which is intende...
Codex – EU, common groundsConsumer, definition‘Consumer’ means persons andfamilies purchasing andreceiving food in order t...
Codex – EU, common groundsLabelling, concept‘Labelling’ includes any written,printed or graphic matter that ispresent on t...
Codex – EU, common groundsLabelling, the golden rule3.1 Prepackaged food shall notbe described or presented onany label or...
Codex – EU, common groundsLabelling, legibility8.1.2 Statements required to appear on thelabel by virtue of this standard ...
Codex – EU, common groundsNutrition labelling2.1 Nutrition labelling is a descriptionintended to inform the consumer ofnut...
Codex – EU, common groundsNutrition labelling2.1 Nutrition labelling is a descriptionintended to inform the consumer ofnut...
Codex – EU, common groundsNutrition labelling, application3.1.1. Nutrient declaration should bemandatory for all prepackag...
Codex – EU, common groundsNutrition labelling, presentation & legibility4.2.2 Format – Nutrient content should bedeclared ...
Codex – EU, common groundsNutrition labelling, thresholdsThere’s no Codex provision about“Contains negligible amounts of.....
Codex – EU, common groundsNutrition claims (1)Low Energy40kcal per 100g, or20kcal per 100mlFree Energy4 kcal per 100 ml (l...
Codex – EU, common groundsNutrition claims (2)NON-ADDITION OF SUGARSClaims regarding the non-addition of sugars to afood m...
EU, health claims, sugar replacers (1)• INGREDIENTS: sugar replacers, i.e. intense sweeteners. Xylitol, sorbitol, mannitol...
EU, health claims, sugar replacers (2)• CLAIM: “CONSUMPTION OF FOODS/ DRINKS CONTAINING <NAME OF SUGARREPLACER> INSTEAD OF...
EU – MS - Codex Alimentarius• Language requirements -> 24 is TOO much!*• National provisions* -> discrimination, TBT vs. f...
EU regulatory frameworkis uncertainty raising?• ANSES (F) takes the lead on RA on energy drinks, bisphenol A, aspartame,GM...
DRV’s for sugars• EFSA scientific opinion on Dietary Reference Values forcarbohydrates and dietary fibre*• Frequency of co...
The aspartame dossier• EFSA has repeatedly confirmed its first TDI (40mg/kg/body weight, 2006)• Latest Call for Data (2011...
Stevia rebaudiana• Approval from the EC in 2011• Consumers may still lack the adequate knowledge to give apositive value a...
Bisphenol A• Plastic boxes of chewing gum may be considered as ahypotetical source of BPA• More than the overall contribut...
‘Post-Normal science’• Under conditions of scientific uncertainty and in the presenceof conflicting opinions - but with a ...
CONCLUSIONS• EFSA is still ‘under attack’. From other scientific bodies at national andinternational level (which paradoxi...
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The relationship between codex standards and European, national Food safety and labbeling Regulation, Dario Dongo, FARE.

  1. 1. The relationships betweenCodex StandardsandEuropean, nationalFood safety and labelling RegulationsDario Dongo © 2013Food law expertBruxelles – Milan – Romedario.dongo@me.com, (+39) 335 7313 726
  2. 2. Premise• The Codex Alimentarius Commission (FAO & WHO, 1963)was builtwith the aim of protecting consumers’ health,by means of science-based common grounds.• ‘The guidelines on food standards and other recommendationsof Codex Alimentarius should be based on the principle of astrict scientific analysis and evidence, with a thoroughreview of all relevant information...’ *• Yet ‘Codex Alimentarius, at the time of the drafting and adoptionof food standards, will also consider, when appropriate, otherlegitimate factors relevant for the health protection ofconsumers and for the promotion of fair practices in foodtrade.’*2(*) FAO, 2002
  3. 3. Codex & WTO, SPS Agreement• Under the SPS agreement, WTO, Codex provides worlwidecriteria for risk assessment (RA)Since the Uruguay Round (1994), Codex Alimentarius is recognised asthe only authoritative body to solve divergencies in RA,* by settingCodex Guidelines• In absence of specific Codex guidelines – or in case of national authoritieswishing to improve the health protection level – Member States must rely onthe risk assessment proceduresThe appropriate level of public health to be pursued by MS, however,should not be discriminatory, but proportionate to the need of free trade,and applied in a responsible manner**3(*) SPS - Sanitary and Phyto-Sanitary measures agreement, Art. 3.1(**) SPS, Art. 5.1
  4. 4. SPS, exceptions• WTO members can adopt temporary SPS measureswhere the relevant scientific evidence is insufficient*Although this step has been regarded as a reflection of theprecautionary principle, the SPS Agreement does not referexplicitly to it. Rather, to the search for an objective riskassessment in due time• Members shall accept the sanitary or phytosanitary measures ofother Members as equivalent, even if these measures differ fromtheir own or from those used by other Members trading in thesame product, if the exporting Member objectively demonstratesto the importing Member that its measures achieve the importingMembers appropriate level of sanitary or phytosanitaryprotection**4(*) SPS, Art. 5.7(**) SPS, Art. 4
  5. 5. Codex Alimentarius & EU• The EC has EXCLUSIVE COMPETENCE for matters on which the ruleshave already been harmonised – fully, or to a large extent - at EU levelIn such cases, the Commission speaks and votes in the name of the EU,although Member States have the right to speak in favour of the Communityposition and to react to contributions from other countries• COMPETENCE is SHARED where rules have been only partiallyharmonizedthe vote is exercised either by the Member States or the Community (i.e.political agriculture, environmental policy, harmonization of human, animal &veg health)• MEMBER STATES have EXCLUSIVE COMPETENCE for allorganisational matters (e.g. legal or budgetary questions) and for proceduralmatters (e.g. election of chairpersons, adoption of agendas, approval of minutes)5Council Decision 2003/822
  6. 6. Codex – EU, common groundsFood, notion‘Food’ means any substance,whether processed, semi-processedor raw, which is intended for humanconsumption, and includes drinks,chewing gum and any substancewhich has been used in themanufacture, preparation ortreatment of ‘food’ but does notinclude cosmetics or tobacco orsubstances used only as drugs.`food’ (or ‘foodstuff’) means anysubstance or product, whetherprocessed, partially processed orunprocessed, intended to be, orreasonably expected to be ingested byhumans. ‘Food’ includes drink, chewinggum and any substance, includingwater, intentionally incorporated intothe food during its manufacture,preparation or treatment.Codex - General Standard for labelling ofpre-packed foods (1985)EU General Food Law(Reg. EC 178/2002 Article 2)6
  7. 7. Codex – EU, common groundsConsumer, definition‘Consumer’ means persons andfamilies purchasing andreceiving food in order to meettheir personal needs‘final consumer’ means theultimate consumer of a foodstuffwho will not use the food as part ofany food business operation oractivity.Codex - General Standard for labelling ofpre-packed foods (1985)General Food Law(Reg. EC 178/02, Article 3)7
  8. 8. Codex – EU, common groundsLabelling, concept‘Labelling’ includes any written,printed or graphic matter that ispresent on the label,accompanies the food, or isdisplayed near the food,including that for the purpose ofpromoting its sale or disposal- ‘labelling’ means any words,particulars, trade marks, brand name,pictorial matter or symbol relating to afood and placed on any packaging,document, notice, label, ring or collaraccompanying or referring to such food+- ‘food information’ means informationconcerning a food and made available tothe final consumer by means of a label,other accompanying material, or anyother means including moderntechnology tools or verbalcommunication (…)Codex - General Standard forlabelling of pre-packed foods (1985)Food Information to Consumer(Reg. EU 1169/2011, Article 2)8
  9. 9. Codex – EU, common groundsLabelling, the golden rule3.1 Prepackaged food shall notbe described or presented onany label or in any labelling in amanner that is false, misleadingor deceptive or is likely tocreate an erroneous impressionregarding its character in anyrespect.Without prejudice to more specificprovisions of food law, the labelling,advertising and presentation offood (…), including their shape,appearance or packaging, thepackaging materials used, themanner in which they are arrangedand the setting in which they aredisplayed, and the informationwhich is made available about themthrough whatever medium, shallnot mislead consumers.Codex - General Standard forlabelling of pre-packed foods (1985)General Food Law(Reg. EC 178/02, Article 16)9
  10. 10. Codex – EU, common groundsLabelling, legibility8.1.2 Statements required to appear on thelabel by virtue of this standard or any otherCodex standards shall be clear, prominent,indelible and readily legible by theconsumer under normal conditions ofpurchase and use.8.1.3 Where the container is covered by awrapper, the wrapper shall carry thenecessary information or the label on thecontainer shall be readily legible throughthe outer wrapper or not obscured by it.+8.1.4 The name and net contents of thefood shall appear in a prominent positionand in the same field of vision‘legibility’ means the physicalappearance of information, by means ofwhich the information is visuallyaccessible to the general populationand which is determined by variouselements, inter alia, font size, letterspacing, spacing between lines, strokewidth, type colour, typeface, width-height ratio of the letters, the surface ofthe material and significant contrastbetween the print and the background+Minimum font size+Name and quantity in the same field ofvisionCodex - General Standard for labellingof pre-packed foods (1985)Food Information to Consumer(Reg. EU 1169/2011, Article 2)10
  11. 11. Codex – EU, common groundsNutrition labelling2.1 Nutrition labelling is a descriptionintended to inform the consumer ofnutritional properties of a food.2.2 Nutrition labelling consists of twocomponents: (a) nutrient declaration;(b) supplementary nutritioninformation.2.3 Nutrient declaration means astandardized statement or listing ofthe nutrient content of a food.‘nutrition declaration’ or ‘nutritionlabelling’ means information statingthe:(a)energy value; or(b) energy value and one or more of thefollowing nutrients only: fat (saturates,mono-unsaturated, polyunsaturated),carbohydrate (sugars, polyols, starch),salt, fibre, protein, any of the vitamins orminerals listed in point 1 of Part A ofAnnex XIII (…)Codex - General Guide onNutrition labelling (1985)Food Information to Consumer(Reg. EU 1169/2011, Annex I)11
  12. 12. Codex – EU, common groundsNutrition labelling2.1 Nutrition labelling is a descriptionintended to inform the consumer ofnutritional properties of a food.2.2 Nutrition labelling consists of twocomponents: (a) nutrient declaration;(b) supplementary nutritioninformation.2.3 Nutrient declaration means astandardized statement or listing ofthe nutrient content of a food.‘nutrition declaration’ or ‘nutritionlabelling’ means information statingthe:(a)energy value; or(b) energy value and one or more of thefollowing nutrients only: fat (saturates,mono-unsaturated, polyunsaturated),carbohydrate (sugars, polyols, starch),salt, fibre, protein, any of the vitamins orminerals listed in point 1 of Part A ofAnnex XIII (…)Codex - General Guide onNutrition labelling (1985)Food Information to Consumer(Reg. EU 1169/2011, Annex I)12
  13. 13. Codex – EU, common groundsNutrition labelling, application3.1.1. Nutrient declaration should bemandatory for all prepackaged foodsfor which nutrition or health claims(…) are made.3.1.2 Nutrient declaration should bemandatory for all other prepackagedfoods except where nationalcircumstances would not supportsuch declarations. Certain foods maybe exempted for example, on thebasis of nutritional or dietaryinsignificance or small packaging.Compulsory nutritiondeclaration for all food items(Article 9, “l”).Exceptions: Chewing gums, amidothers, are EXEMPTED (Annex V)Codex - General Guide onNutrition labelling (1985)Food Information to Consumer(Reg. EU 1169/2011, Annex I)13
  14. 14. Codex – EU, common groundsNutrition labelling, presentation & legibility4.2.2 Format – Nutrient content should bedeclared in a numerical, tabular format.Where there is insufficient space for a tabularformat, nutrient declaration may be presentedin a linear format.4.2.3 Nutrients should be declared in a specificorder developed by competent authorities andshould be consistent across food products.4.2.4 Font – The font type, style and a minimumfont size as well as the use of upper and lowercase letters should be considered by competentauthorities to ensure legibility of nutritionlabelling.4.2.5 Contrast – A significant contrast shouldbe maintained between the text andbackground so as to be that the nutritioninformation is clearly legible.1. The particulars referred to in Article 30(1)and (2) shall be in the same field of vision. Theyshall be presented together in a clear formatand, where appropriate, in the order ofpresentation provided for in Annex XV.2. The particulars referred to in Article 30(1)and (2) shall be presented, if space permits, intabular format with the numbers aligned.Where space does not permit, the declarationshall appear in linear format.3. The particulars referred to in Article 30(3)shall be presented:(a) in the principal field of vision; and(b) using a font size in accordance with Article13(2).Codex - General Guide onNutrition labelling (1985)Food Information to Consumer(Reg. EU 1169/2011, Article 34)14
  15. 15. Codex – EU, common groundsNutrition labelling, thresholdsThere’s no Codex provision about“Contains negligible amounts of...”5. In cases where the energyvalue or the amount ofnutrient(s) in a product isnegligible, the information onthose elements may bereplaced by a statement suchas ‘Contains negligibleamounts of …’ and shall beindicated in close proximity tothe nutrition declaration whenpresent.Codex - General Guide onNutrition labelling (1985)Food Information to Consumer(Reg. EU 1169/2011, Art. 34)15
  16. 16. Codex – EU, common groundsNutrition claims (1)Low Energy40kcal per 100g, or20kcal per 100mlFree Energy4 kcal per 100 ml (liquids)Sugars Free 0.5g per 100 g/mlLow energySame conditions as Codex+-> Table-top sweeteners, 4kcal/portion, withequivalent sweetening properties to 6g of sugarFree energy (‘0 calories’)Same as Codex+-> Table-top sweeteners, 0,4kcal/portion,with equivalent sweetening properties to 6g ofsugarSugars free, same asCodex Guidelines for the use ofNutrition & Health ClaimsNHC Regulation(Reg. EC 1924/06, Annex)16
  17. 17. Codex – EU, common groundsNutrition claims (2)NON-ADDITION OF SUGARSClaims regarding the non-addition of sugars to afood may be made provided the followingconditions are met.(a) No sugars of any type have been added tothe food (Examples: sucrose, glucose, honey,molasses, corn syrup, etc.);(b) The food contains no ingredients that containsugars as an ingredient (Examples: jams, jellies,sweetened chocolate, sweetened fruit pieces,etc.);(c) The food contains no ingredients containingsugars that substitute for added sugars(Examples: non-reconstituted concentrated fruitjuice, dried fruit paste, etc.); and(d) The sugars content of the food itself has notbeen increased above the amount contributed bythe ingredients by some other means (Example:the use of enzymes to hydrolyse starches torelease sugars)WITH NO ADDED SUGARSA claim may only be made where theproduct does not contain any addedmono- or disaccharides or any other foodused for its sweetening properties. Ifsugars are naturally present in the food, thefollowing indication should also appear onthe label: ‘CONTAINS NATURALLYOCCURRING SUGARS’.Diverging interpretations amid MSauthorities -> enforcement troublesCodex Guidelines for the use ofNutrition & Health ClaimsNHC Regulation(Reg. EC 1924/06, Annex)17
  18. 18. EU, health claims, sugar replacers (1)• INGREDIENTS: sugar replacers, i.e. intense sweeteners. Xylitol, sorbitol, mannitol,maltitol, lactitol, isomalt, erythritol, sucralose and polydextrose; D-tagatose andisomaltulose• CLAIM: “CONSUMPTION OF FOODS/ DRINKS CONTAINING <NAME OF SUGARREPLACER> INSTEAD OF SUGAR (*) INDUCES A LOWER BLOOD GLUCOSE RISE AFTERTHEIR CONSUMPTION COMPARED TO SUGAR- CONTAINING FOODS/DRINKS”• CONDITIONS OF USE: In order to bear the claim, sugars should be replaced in foods ordrinks by sugar replacers, i.e. intense sweeteners, xylitol, sorbitol, mannitol, maltitol,lactitol, isomalt, erythritol, sucralose or polydextrose, or a combination of them, so thatfoods or drinks contain reduced amounts of sugars by at least the amount referred to inthe claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No1924/2006. In the case of D-tagatose and isomaltulose, they should replace equivalentamounts of other sugars in the same proportion as that referred to in the claimREDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/200618Reg.(EU) 432/2012
  19. 19. EU, health claims, sugar replacers (2)• CLAIM: “CONSUMPTION OF FOODS/ DRINKS CONTAINING <NAME OF SUGARREPLACER> INSTEAD OF SUGAR (**) CONTRIBUTES TO THE MAINTENANCE OF TOOTHMINERALISATION”• CONDITIONS: in order to bear the claim, sugars should be replaced in foods or drinks(which reduce plaque pH below 5.7) by sugar replacers, i.e. intense sweeteners, xylitol,sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose,sucralose or polydextrose, or a combination of them, in amounts such that consumptionof such foods or drinks does not lower plaque pH below 5.7 during and up to 30 minutesafter consumption19Reg.(EU) 432/2012
  20. 20. EU – MS - Codex Alimentarius• Language requirements -> 24 is TOO much!*• National provisions* -> discrimination, TBT vs. free circulation of goods• Nutrition declaration –> Sodium* vs. Salt (as Sodium equivalent)• Comparative claims –> 30** vs. 25%. Terms of reference• Health claims -> clinical data based on double blind tests on healthyindividuals*** vs. generally accepted scientific evidence20Labelling, space for improvement(*) Reg. EU 1169/11(**) Reg. EC 1924/06(***) Reg. EC 353/08
  21. 21. EU regulatory frameworkis uncertainty raising?• ANSES (F) takes the lead on RA on energy drinks, bisphenol A, aspartame,GMOs ... BEFORE AND BESIDE EFSA!• BfR (D) also• UK runs ahead (i.e. traffic light hybrid system and Reg. UE 1169/11)• Both issues - food safety and labelling – are under the focus of many21
  22. 22. DRV’s for sugars• EFSA scientific opinion on Dietary Reference Values forcarbohydrates and dietary fibre*• Frequency of consumption of sugars seems morerelevant than overall quantity -> clear understandingthat candies and chewing gum have a great potentialfor a negative impact• However, not intervening on sugars daily DRVs leftconsumers and NGOs with suspects of industry-drivenrisk assessment -> (see EFSA’s page on scientific controversieshttp://www.efsa.europa.eu/en/faqs/faqdrv.htm)22(*) EFSA Journal 2010; 8(3):1462 [77 pp.]
  23. 23. The aspartame dossier• EFSA has repeatedly confirmed its first TDI (40mg/kg/body weight, 2006)• Latest Call for Data (2011) led EFSA to retrive 112unpublished scientific works and data used to approve it• Rumors and conditioning factors. No other EU MemberState has ever banned nor restricted aspartame usefrom 1971 to date• Final opinion (re-evaluation) is expected from EFSA byNovember 201323
  24. 24. Stevia rebaudiana• Approval from the EC in 2011• Consumers may still lack the adequate knowledge to give apositive value and a prominent role to Stevia in the ‘nocalories sweeteners’ list• Costs. Aspartame 30 US$/kg, Stevia drops >100 $/kgAre there new chances for its extensive use?24Commission Reg. (EU) No 1131/2011
  25. 25. Bisphenol A• Plastic boxes of chewing gum may be considered as ahypotetical source of BPA• More than the overall contribution to Tolerable WeeklyIntake/Tolerable Daily Intake, which could be a minor/ of noconcern, attention should be paid to the consumers’ response• Steady adoption of ‘BPA-free’ regulatory environments at theMS level could foster industry to adopt new BPA-free technologyeven in countries where it is still allowed25
  26. 26. ‘Post-Normal science’• Under conditions of scientific uncertainty and in the presenceof conflicting opinions - but with a social urgency of theintroduction of technology (market demand) - science cannotproceed for successive ‘jumps’ from one paradigm to another[Kuhn , 1962], with phases of standardization in the middle(‘normal science’)• This is the ‘post-normal science’ [Funtowicz, 1992, 1993], a‘post-modernist’ interpretation of the scientific method• Science would no longer explain reality. RISK ASSESSMENT isplural, controversial, relative, path dependent, society &stakeholders sensitive*• More room is left to the Science-Policy making-Regulatoryaffairs-Media INTERPLAY26See FAO (2002), ‘other legitimate factor’, in addition to science
  27. 27. CONCLUSIONS• EFSA is still ‘under attack’. From other scientific bodies at national andinternational level (which paradoxically form the network EFSA is builton!) and the (sometimes interested) stakeolders• The consequent lack of scientific clarity and/or its recognition may- DELAY INNOVATION and public acceptance of new technologies andsubstances- PROVIDE OPPORTUNITIES for those who wish to set any kind of rules- DECREASE HARMONIZATION OF FOOD SAFETY STANDARDS, by leavingground to SAFEGUARDS CLAUSES AT NATIONAL LEVEL. This holdsparticularly true for those Member States having powerful food safetyassessment bodies (F, D, UK), and generally speaking, more politicalstrenght27

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