Circ FEDALIM 44 12 tolerances declaration nutritionnelledoc.fedalim.com/FEDALIM/Circ_FEDALIM_44_12_tolerances_declaration... · l’ERNA2 et de l’AESGP3 sur les tolérances, qui

______________________________ F E D A L I M

F E D A L I M

8, RUE DE L’ISLY – 75008 PARIS - TELEPHONE 01 53 42 33 80 – TELECOPIEUR 01 53 42 33 81

E-Mail : [email protected]

Site : http://www.fedalim.com

Paris, le 16 novembre 2012

44/12 INFORMATION DU CONSOMMATEUR : PROJET DE TOLERANCES APPLICABLES A L’ETIQUETAGE NUTRITIONNEL

Madame, Monsieur, Pour mémoire, l’ANIA a publié, le 9 juillet 2009, un guide intitulé « recommandations pratiques sur l’étiquetage nutritionnel », pour aider les industriels de l’agroalimentaire à mettre en place un étiquetage nutritionnel. Ce guide a été amendé, le 2 avril 2012, à la suite des dernières remarques faites par la DGCCRF (ANNEXE I). Cependant, il n’a pas pu être validé par la DGCCRF du fait des discussions actuelles entre la Commission européenne et les Etats membres, dans le cadre du règlement INCO. En effet, conformément à l’article 31 du règlement (UE) n° 1169/2011, « la Commission peut adopter des actes d’exécution fixant les modalités pour l’application uniforme […] en ce qui concerne la précision des valeurs déclarées et notamment les écarts entre les valeurs déclarées et celles constatées lors des contrôles officiels. » Veuillez trouver, ci-joint, la cinquième version du document de travail proposé par la Commission aux Etats membres, qui devrait être soumise au CPCASA, le 10 décembre prochain (ANNEXE II). Vous constaterez que le projet de la Commission est plus restrictif que la position française actuelle.

Les principales différences sont surlignées dans le tableau, ci-après.

De ce fait, l’ANIA a insisté auprès de la DGCCRF pour considérer le document de la Commission comme un document « test » afin d’évaluer les pourcentages de dépassements avec les valeurs proposées par la Commission. L’ANIA souhaite que, pendant cette période de « test », les contrôles officiels pour déterminer toute non-conformité se réfèrent encore à la position française. La Commission européenne propose une période de transition d’un an alors que FoodDrinkEurope, pour sa part, souhaiterait deux ans de période de test.

______________________________ F E D A L I M

2

Draft guidance of European Commission (version Nov 2012)

Projet position ANIA-FCD (02.04.2012)

Vitamins

Vitamin C

+50 -35 %

+80 -35 %

+100 -30 %

+200 -30 %

Minerals

+45 -35 % Majeurs (Na, K, Ca, Mg, P, Cl) : <30 mg : ±9 mg ≥30 mg : ±30 %

Mineurs (Cu, Zn, Mn, Fe, F, Se, Cr, Mo, I) : <0,5 mg : ±60 % ≥0,5 mg <1 mg : ±0,3 mg ≥1 mg : ±30 %

Carbohydrate Sugars Protein Fibre Fat

<10 g per 100 g: ±2 g 10-40 g per 100 g: ±20 % >40 g per 100 g: ±8 g

Sauf fat : <10 g per 100 g: ±1,5 g 10-40 g per 100 g: ±20 % >40 g per 100 g: ±8 g

< 4 g pour 100 g: ±1 g ≥ 4 g pour 100 g : ±25 %

Sauf fibres : < 3g/100 g : ±1,2 g ≥ 3 g/100 g : ±40 %

Saturates Mono-unsaturates Polyunsaturates

< 4 g per 100 g: ±0,8 g ≥ 4 g per 100 g: ±20 %

< 4 g pour 100 g : ±1 g ≥ 4 g pour 100 g : ±25 %

Sauf Oméga 3 et 6, ALA, DHA, LA : ± 45%

Sodium < 0,5 g per 100 g: ±0,15 g ≥ 0,5 g per 100 g: ±20 %

<30 mg pour 100 g : ±9 mg ≥30 mg pour 100 g : ±30 %

Salt < 1,25 g per 100 g: ±0,375 g ≥ 1,25 g per 100 g: ±20 %

pour le « sel » le résultat analytique sera en sodium. Cela ne changera pas la position puisque la masse atomique du sodium est 23 et la masse moléculaire du NaCl est 58,5. Ce qui est de l’ordre d’un facteur 2.

En complément, vous trouverez, ci-joint, la position commune de FoodDrinkEurope, de l’EHPM1, l’ERNA2 et de l’AESGP3 sur les tolérances, qui a été présentée, le 6 novembre dernier, à la DG Entreprises (ANNEXE III). Nous restons à votre disposition pour tout renseignement complémentaire et vous prions d'agréer, Madame, Monsieur, l'expression de nos sentiments distingués.

Jeanne SIMONEAU Chargée de mission

1 EHPM : European Federation of Associations of Health Product Manufacturers. 2 ERNA : European Responsible Nutrition Alliance. 3 AESGP : Association of the European Self-Medication Industry.

1 ANIA - 21, rue Leblanc – 75015 PARIS FCD - 12, rue Euler – 75008 PARIS

Té. / 01.53.83.86.00 / Fax : 01.53.83.92.39 Té : 01.44.43.99.00 – Fax : 01.47.20.53.53 http ://www.ania.net http: www.fcd.asso.fr

Position relative aux tolérances et arrondis

dans l’étiquetage nutritionnel :

2 avril 2012 ETIQ 12-0402 – Version modifiée suite au courrier de la DGCCRF du 30.03.12.

Préambule Les tolérances fixées ci-après ont pour objet de déterminer les écarts admis entre les valeurs déclarées sur l’étiquetage nutritionnel des produits tels que vendus destinés au consommateur final et celles constatées lors des contrôles officiels. Ces tolérances englobent l’ensemble des facteurs de variabilité dont les incertitudes analytiques. Cette position prévoit qu’au-delà des limites indiquées, les produits sont susceptibles d’être jugés comme non conformes. Des dépassements sont possibles mais l’opérateur doit être en mesure de les justifier. In fine, les valeurs affichées ne doivent pas être de nature à induire le consommateur en erreur

1- Les valeurs déclarées sont des valeurs moyennes Il est nécessaire de rappeler que les valeurs déclarées sont des valeurs moyennes conformément aux textes réglementaires (Directive 90/496/CEE transcrite en droit français par le décret 93-1130 du 27 septembre 1993 et l’arrêté d’application du 3 décembre 1993) qui prévoit un étiquetage volontaire de la composition nutritionnelle des produits alimentaires. Cet étiquetage nutritionnel peut se faire sur la base :

- de l’analyse de l’aliment effectuée par le fabricant ; - et/ou du calcul effectué à partir des valeurs moyennes connues ou effectives relatives

aux ingrédients utilisés ; - et/ou du calcul effectué à partir de données généralement établies et acceptées.

En pratique, il appartient au fabricant de décider de la meilleure façon d’établir les valeurs nutritionnelles, au cas par cas, sachant qu’il est toujours possible de recourir à une synthèse des résultats obtenus par analyses et par calcul, pourvu que les valeurs étiquetées soient cohérentes et justifiables. Les valeurs retenues devront être choisies de manière pertinente, au cas par cas, selon le type de produits. Les tolérances entre valeurs affichées sur l’emballage et analyses éventuellement réalisées a posteriori, incertitudes analytiques incluses, sont nécessaires pour tenir compte à la fois : � de la nature des nutriments et de leurs sensibilités (ex : vitamine C, etc.) � de la variabilité de la matière première et de la fluctuation des teneurs naturelles

notamment :

Technique

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ANNEXE I



o dans le cas des denrées animales : liée à l’espèce, à l’alimentation des animaux, cette alimentation pouvant elle-même varier selon les saisons, au cycle physiologique, au prélèvement, à la variation naturelle de certains nutriments dans la matière première (Ex : sodium dans les produits de la mer).

o dans le cas des denrées végétales : liée à la variété, à la saison, au temps, au sol, au mode de culture…

� du procédé o de fabrication utilisé : par exemple types de mélange (à sec, humide, etc.),

assemblage, transport pneumatique, traitement thermique, incidence de l’eau, pH, lumière, etc. et autres facteurs de dégradation potentielle des vitamines, fermentation (facteur temps), aspect granulométrie des matières premières et des substances ajoutées (ex. : vitamine A encapsulée / vitamine C), utilisation de prémélanges, moment d'incorporation, moyen d'adjonction, etc.

o du type d’emballage et du mode de conservation (opacité, étanchéité (air, oxygène,…), températures, pertes d’eau par évaporation, etc.) des conditions de transport et de stockage, de la durée de vie du produit, etc.

� des incertitudes des matériels de dosage de l’outil industriel (pesons, pompes, doseuses, etc.)

� des méthodes d’analyses utilisées o échantillonnage, prélèvement, etc. o des incertitudes des mesures : fiabilité et reproductibilité de la méthode,

reproductibilité inter-laboratoire � des incertitudes induites par la méthodologie d’obtention des tables de valeurs de

référence � des arrondis puisque les teneurs affichées incluent les arrondis.

2- Les tolérances sont des repères Les tolérances constituent des repères pour les opé rateurs. � Ces repères ne dispensent pas l’opérateur d’avoir à disposition les éléments justificatifs

de l’établissement des valeurs déclarées et des écarts constatés. Ils ne doivent pas constituer un biais pour des adjonctions excessives ou trop faibles injustifiées, ni pour des déviations systématiques.

� Les dépassements par rapport à ces repères sont possibles. Dans ce cas, l’opérateur doit pouvoir justifier de ses bonnes pratiques de fabrication. Exemples :

- Cas de lipides dans les poissons gras, qui nécessitent une tolérance plus importante que celle prise en compte ci-dessous (Position AIPCE-CEP sur les tolérances nécessaires pour les produits à base de poisson). C’est en particulier le cas pour les Oméga 3 dans les poissons gras (ou les produits en contenant et dont l’apport en oméga 3 vient quasiment de manière exclusive du poisson) pour lesquels les fluctuations naturelles observées conduisent au dépassement des fourchettes proposées.)

- Cas des vitamines B dans les produits laitiers frais ; - Cas des minéraux, de la vitamine A et des vitamines du groupe B pour les jus et

nectars de fruits. � Au-delà des valeurs des limites indiquées, les produits sont susceptibles d’être jugés non

conformes, sous réserve de justification. � Le produit doit rester conforme aux tolérances définies ci-après tout au long de sa durée

de vie. � In fine, les valeurs affichées ne doivent pas être de nature à induire le consommateur en

erreur.



3- Tolérances dans le cadre de l’étiquetage nutriti onnel

Les tolérances admises dans le cadre de l’étiquetage nutritionnel sont ceux indiqués dans le tableau ci-dessous exceptés si ces tolérances sont définies par la réglementation (Ex réglementation concernant la matière grasse dans la viande hachée) ou dans les cas particuliers listés au paragraphe 4.

Elément / Catégorie/ Nutriment tel qu’étiqueté

Tolérances acceptées (pour 100g ou 100 ml)

Energie* ± 25%

Protéines , Glucides, Amidon, Sucres, Lipides, AGS, AGMI et AGPI

± 25% si ≥ 4 g ± 1 g si < 4 g

Omégas 3 /ALA/DHA Omégas 6/ LA ± 45%

Vitamines - 30% + 100% Exception : Vitamine C - 30% + 200%

Minéraux éléments majeurs : Na**, K, Ca, Mg, P, Cl ± 30% si ≥ 30 mg ± 9 mg si < 30 mg

Minéraux éléments mineurs ou traces : Cu, Zn, Mn, Fe, F, Se, Cr, Mo, I

± 30% si ≥ 1 mg ± 0,3 mg si < 1 mg et ≥ 0,5 mg ± 60% si < 0,5 mg

* Cette teneur s’obtient par calcul à partir des valeurs arrondies auxquelles on applique les facteurs de

conversion de la directive 90/496/CEE et ses modifications (directive 2008/100), quelle que soit l’unité (kcal ou kJ), sans recours au facteur 4,18.

** Concernant le « sel », en première approche, pour le sel le résultat analytique sera en sodium. Cela ne changera pas la position puisque la masse atomique du sodium est 23 et la masse moléculaire du NaCl est 58,5. Ce qui est de l’ordre d’un facteur 2.

Fibres alimentaires : � il s’agit d’un cas particulièrement complexe. Il est difficile de déterminer des tolérances

pour les fibres alimentaires, compte-tenu des discussions en cours sur les méthodes d’analyses à prendre en compte.

� A titre d’information, une estimation des tolérances à appliquer pourrait être la suivante : - ± 40% si > 3 g/100 g ou 100 ml - ± 1,2 g pour 100 g si < 3 g/100 g ou 100 ml

Remarque : Dans le cas d’un étiquetage du groupe 1, la prise en compte des fibres dans le calcul de l’énergie n’est pas nécessaire s’il a été vérifié au préalable, dans la littérature ou par analyse, qu’elle ne dépasse pas 1 g/100 kcal1.

1Ceci permet de ne pas dépasser une erreur induite de plus de 2% sur le calcul de la valeur énergétique.



4- Tolérances spécifiques sur l’étiquetage nutritio nnel en cas d’emploi

d’allégations nutritionnelles ou de santé, en cas d es critères nutritionnels fixés par la réglementation et pour l es compléments alimentaires

Les valeurs de tolérances proposées dans le chapitre 3 ne visent que la mise en œuvre des dispositions relatives à l’étiquetage nutritionnel. Elles ne sont donc pas applicables lors du contrôle des allégations nutritionnelles ou de santé sur l’étiquetage ou dans la publicité des denrées alimentaires, ni lors du contrôle des critères nutritionnels fixés par la réglementation (exemple des aliments de l’enfance et des aliments destinés à des fins médicales spéciales) ou du contrôle des compléments alimentaires. En cas d’allégations, de critères nutritionnels fixés par la réglementation, les facteurs de variations listés au paragraphe 1 restent les mêmes (Sensibilités des nutriments à la chaleur, oxydation, variabilité de la matière première et de la fluctuation des teneurs naturelles, du procédé de fabrication utilisé, du type d’emballage et du mode de conservation, des incertitudes des matériels de dosage de l’outil industriel, des méthodes d’analyses utilisées, des incertitudes des mesures, etc.). Les tolérances applicables dans ces cas de figure sont, par nature plus restrictives que celles retenues pour l’étiquetage nutritionnel pour lesquels, uniquement, la réglementation prévoit qu’il soit basé sur une valeur moyenne des teneurs. Des tolérances spécifiques ont été proposées par la DGCCRF.

a) Cas des produits règlementés ou des allégations La proposition suivante est effectuée pour ce qui concerne les tolérances analytiques des produits réglementés ou des allégations

Elément / Catégorie/ Nutriment tel qu’étiqueté

Tolérances acceptées (pour 100g ou 100 ml)

Energie* ± 15%

Protéines , Glucides, Amidon, Sucres, Lipides, AGS, AGMI et AGPI

± 15% si ≥ 4 g ± 0,6 g si < 4 g

Omégas 3 /ALA/DHA Omégas 6/ LA ± 30%

Vitamines - 25% + 75% Exception : Vitamine C - 25% + 150%

Minéraux éléments majeurs : Na**, K, Ca, Mg, P, Cl ± 20% si ≥ 40 mg ± 8 mg si < 40 mg

Minéraux éléments mineurs ou traces : Cu, Zn, Mn, Fe, F, Se, Cr, Mo, I

± 20% si ≥ 1 mg ± 0,2 mg si < 1 mg et ≥ 0,5 mg ± 40% si < 0,5 mg

La justification des écarts observés (tolérances) est sous la responsabilité de l’opérateur. In fine, les valeurs affichées ne doivent pas être de nature à induire le consommateur en erreur.

b) Cas des compléments alimentaires Pour les compléments alimentaires il apparaît logique que les tolérances pour les vitamines et minéraux soient pratiquement égales aux incertitudes d’analyses. Pour les compléments alimentaires, il ne semble pas possible d’accepter des tolérances non symétriques dans la mesure où les teneurs en vitamines restent relativement constantes dans le temps dans ce type d’échantillon.



5- Arrondis dans le cadre de l’étiquetage nutrition nel, de l’emploi

d’allégations nutritionnelles ou de santé, ou en ca s de critères nutritionnels fixés par la réglementation

Les arrondis admis par la DGCCRF dans le cadre de l’étiquetage nutritionnel sont les suivants :

• Energie : arrondir à l’unité près (sans décimales) dans tous les cas • Protéines, glucides, lipides, amidon, sucres, polyo ls et fibres :

o Si valeur < 0,5g par 100 ml ou par 100 g : « contient des quantités négligeables de … »2, ou « traces » ou <0,5 g

o Si valeur ≥ 0,5 g par 100 ml ou par 100 g : arrondir à 0,1g dans tous les cas

• Vitamines et minéraux (y compris le sodium) : o Arrondir à 3 chiffres significatifs

� 2 chiffres après le zéro et la virgule. Ex : 0,12 � 3 chiffres s’il y a un chiffre non nul avant la virgule. Ex : 1,24 et 12,4

o 3 chiffres au dessus de la virgule. Ex : 124 et 1240 et 12400. Exprimer les teneurs sur la base des unités figurant dans l’arrêté modifié de 1993.

� mg pour les vitamines B, B2, B3, B5, B6, C, E, béta-carotène, ainsi que : chlorure, calcium, phosphore, magnésium, fer, zinc, cuivre, manganèse et fluorure ;

� µg pour les vitamines A, B8, B9, B12, D, K, ainsi que sélénium, chrome, molybdène, iode ;

� g pour le sodium. Ces propositions permettent de ne pas augmenter artificiellement l’écart entre la valeur étiquetée (si elle est calculée et/ou déterminée par l’analyse) et le résultat retrouvé à l’analyse effectuée dans le cadre du contrôle officiel.

2Dans le texte original du règlement n° 1169/2011 co ncernant l’information des consommateurs sur les denrées alimentaires, les dispositions de l’article 34.5 prévoient que « In cases where the energy value or the amount of nutrient(s) in a product is negligible, the information on those elements may be replaced by a statement such as ‘Contains negligible amounts of …’ and shall be indicated in close proximity to the nutrition declaration when present. ».

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EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL

NovemberOctober 2012

DRAFT GUIDANCE DOCUMENT FOR COMPETENT AUTHORITIES FOR THE CONTROL OF COMPLIANCE WITH EU

LEGISLATION ON:

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 and Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling of foodstuffs and Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

with regard to the setting of tolerances for nutrient values

declared on a label

IMPORTANT DISCLAIMER

"This Document has no formal legal status and, in the event of a dispute, ultimate responsibility for the interpretation of the law lies with the Court of Justice

of the European Union"

Note

This document is an evolving document and will be updated to take account of the experience of the competent authorities or of information provided

Technique

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ANNEXE II

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1. INTRODUCTION

Tolerances for nutrition labelling purposes are important as it is not possible for foods to always contain the exact nutrient levels labelled, due to natural variations and variations from production and during storage. However, the nutrient content of foods should not deviate substantially from labelled values to the extent that such deviations could lead to consumers being misled.

This document has been drawn up by mutual agreement between the Commission departments and the representatives of the Member States. The guidelines given in this document cannot be regarded as official interpretation of the legislation, this being the exclusive reserve of the judicial powers, i.e. the national courts and the Court of Justice of the European Union.

After reaching agreement on this guidance document, Member States are reminded that all controls carried out to verify the compliance with the relevant labelling requirements, taking into account the described tolerances, shall be accounted for in the Multi-annual national control plans, as required by Article 41 of Regulation (EC) No 882/2004 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. Member States also have to report back yearly to the Commission on the results of such controls according to Article 44 of Regulation (EC) No 882/2004 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. In the latter context, Member States are encouraged to provide the Commission with the number of tests performed, the food categories tested, the results of the tests compared with the values that were controlled and the decisions taken, e.g. measures taken in case the measured value was outside the tolerance of the declared value. Based on the experiences gained the Commission and the Member States can discuss and agree on modifications of the guidance document. The Commission recommends that a pragmatic approach should be followed for the adaptation of official controls on the basis of this EU guidance on tolerances. Therefore, it could be accepted that for a certain period of time apply a smooth transition, which should end at the latest on 13 December 2014, and inform economic operators accordingly. Also, Member States that had already national provisions on tolerances in place before this guidance was published may consider to apply a smooth transition to controls of products labelled prior to and during such a transition period 1.1 Scope of this guidance

This document (hereinafter: 'this guidance') has been prepared to provide guidance to Member States' control authorities and food business operators on the tolerances for nutrition labelling purposes. Tolerances mean the acceptable differences between the nutrient values declared on a label and those established in the course of official controls, in relation to the 'nutrition declaration' or 'nutrition labelling' as described in Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers1; Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs2; and in relation to the nutrition labelling of food supplements, as described in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements3.

1 OJ L 304, 22.11.2011, p. 18 2 OJ L 276, 6.10.1990, p. 40 3 OJ L 183, 12.7.202, p. 51

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This guidance is, in general, also applicable for the nutrition labelling of foods under Regulations (EC) No 1925/2006/EC of the European Parliament and the Council on the addition of vitamins minerals and of certain other substances to foods4 and No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods5. Guidance on such tolerances is given in sections 3 and 4 of this document. Levels of nutrients and other substances in foods are measured by Member States' control authorities in order to control the compliance with levels of nutrients and other substances specified in the conditions of use for nutrition claims as listed in the Annex to Regulation (EC) No 1924/2006 and for health claims as authorised via implementing measures of the Regulation. Tolerances for such controls are specified in section 5 of this document. Levels of vitamins and minerals added to foods as regulated by Regulation (EC) No 1925/2006/EC are measured by Member States' control authorities in order to control the compliance with levels of nutrients declared in the nutrition labelling. Tolerances for such controls are specified in section 5 of this document. This guidance does not cover tolerances around the declared value for levels of vitamins and minerals added to foods when the addition is mandatory according to national provisions as described in Article 11 of Regulation (EC) No 1925/2006. Furthermore, this guidance does not cover tolerances around the declared values for foods regulated by Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses6

1.2 The legislative framework related to control of nutrient values declared on a label

Article 17 of the Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety7 (General Food Law) provides that Member States have the responsibility to enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by feed and food business operators at all stages of production, processing and distribution. For that purpose, Member States shall maintain a system of official controls and other activities as appropriate to the circumstances. Article 3 of the official Feed and Food Control Regulation (EC) No 882/2004 on the general obligations with regard to the organisation of official controls provides that Member States shall ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency, so as to achieve the objectives of the Regulation taking into account:

• identified risks associated with animals, feed or food, feed or food businesses, the use of feed or food or any process, material, substance, activity or operation that may influence feed or food safety, animal health or animal welfare;

• feed or food business operators' past record as regards compliance with feed or food law or with animal health and animal welfare rules;

4 OJ L 404, 30.12.2006, p. 26 5 OJ L 404, 30.12.2006, p. 9 6 OJ L 124, 20.5.2009, p. 21

7 OJ L 31, 1.2.2002, p. 1

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• the reliability of any own checks that have already been carried out; and

• any information that might indicate non-compliance.

Official controls shall be applied, with the same care, to exports outside the Union, to the placing on the market within the Union and to introduction from third countries. Member States shall also take the necessary measures to ensure that products intended for dispatch to another Member State are controlled with the same care as those intended to be placed on the market in their own territory. As regards the control of nutrient values declared on a label, in addition to the above mentioned general control provisions, three legislative texts are concerned:

• Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers

• Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs

• Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements

Regulation (EU) No 1169/2011 will apply from 13 December 2014 and at the same time Directive 90/496/EEC will be repealed.

Without prejudice to specific provisions in the different pieces of legislation, rules about nutrition labelling of one or more of the three pieces of legislations mentioned above apply also to Regulation (EC) No 1924/2006/EC, Regulation (EC) No 1925/2006 and to Directive 2009/39/EC. Directive 90/496/EEC and Regulation (EU) No 1169/2011 indicate that the energy and nutrient content should be labelled as the 'average value', which means the value that best represents the amount of the nutrient which a given food contains, and allows for natural variability of foodstuffs, seasonal variability, patterns of consumption and other factors which may cause the actual value to vary. The declared values shall, according to the individual case, be average values based on:

a) the manufacturer's analysis of the food;

b) a calculation from the known or actual average values of the ingredients used;

c) a calculation from generally established and accepted data.

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2. GENERAL PRINCIPLES

The actual amount of a nutrient in a product may vary compared to the value declared on a label due to factors such as the source of values (values derived from literature and calculated by recipe instead of analysis), the accuracy of analysis, the variation in the raw materials, the effect of processing, nutrient stability and storage conditions and storage time.

2.1 Tolerances and food safety issues

The factor of food safety should be taken into account when setting tolerances for added vitamins and minerals to food including food supplements. Excessive intakes of vitamins and minerals may result in adverse effects and it is therefore necessary to set maximum amounts for them when they are added to foods or present in food supplements. Provisions for establishing maximum amounts for vitamins and minerals are included in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and in Directive 2002/46/EC on food supplements. The tolerance range around a declared value may extend above the maximum amount of vitamins or minerals added to foods or present in food supplements harmonised at EU level according to the provisions in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and according to the provisions in Directive 2002/46/EC on food supplements. In this case, the maximum amount has priority over the tolerance range around the declared value and would therefore limit the upper end of the tolerance around the declared value. In the absence of harmonised rules on maximum amounts in foods and food supplements Member States may establish national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union. However, in doing so, they should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC. In case the tolerance range around a declared value extends above the maximum amount established by Member States as national rules, in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union, for which Member States should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC, the current practice of handling such issues before this guidance document was agreed may be maintained.

2.2 Compliance over shelf life

The measured value should be within the tolerances around the declared value during the entire shelf life.

2.3 Application of tolerance ranges of section 3 and section 5.2

Tolerances for nutrition labelling purposes are important as it is not possible for foods to always contain the exact levels of energy and nutrients that are labelled, due to natural variations and variations from production and during storage. However, the nutrient content of foods should not deviate substantially from labelled values to the extent that such deviations could lead to consumers being misled.

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The declared valuesnutrition declarations should, according to the individual case, be average values and based on

a) the manufacturer's analysis of the foodaverage nutrition content of a food over a number of samples with different batch codes / lot numbers, within a defined period of time or;

b) a calculation from the known or actual average values of the ingredients used; or the values calculated from the known or actual average values of the ingredients used or

c) a calculation the values calculated from generally established and accepted data.

Regardless of how nutrition declarations are derived, food business operators should act in good faith to ensure a high degree of accuracy of those nutrition declarations. In particular, declared values should approximate to the average values across multiple batches of food and should not be established at either extreme of a defined tolerance range. For nutrients where consumers are generally interested in reducing their intakes (such as fats, sugars and salt/sodium), the declared values should not be established at the lower tolerance range whilst the measured or calculated average value would be higher than this declared value. Also, for nutrients where consumers are generally interested in higher levels, the declared values should not be established at the higher tolerance range whilst the measured or calculated average value would be lower than this declared value.

2.4 Aspects to be taken into account when the measured value is outside the tolerance for the declared value

If the value measured is outside the tolerance for the declared value this will always be subject to a specific assessment to decide whether some action/measures should be taken. The following aspects should, for example, be taken into account in this consideration:

a) the nutrient in question

b) the extentsize of the deviation

c) the nature of the deviation (overestimation or underestimation) in relation to the nutrient concerned

d) natural high variation of the nutrient, including seasonality

e) particular high degradation rates of nutrients in some food matrices

f) particular high analytical variability of nutrients in a specific food matrix

g) particular low homogeneity of a product leading to particular high variation of nutrient content in a product that is not offset by the sampling procedure

h) compliance of the majority of samples from the lot with the tolerance range, if such data is available

i) validity of the manufacturer's process for establishing the declared nutrient value

j) how the self-monitoring of the company functions in general

k) previous problems or previous sanctions against the company

These aspects will also influence the degree of sanctions if they are considered necessary, whether it should be, for example, extended guidelines, warnings, enforcement notice or fines.

Manufacturers may be asked to provide the rationale justifying deviation from tolerances and details on the particular reasons appearing.

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3. TOLERANCES FOR NUTRIENT DECLARATION ON FOODS

The tolerance values listed include the uncertainty of measurement associated with a measured value. Therefore, no further allowance for uncertainty of measurement has to be made when deciding whether a measured value is compliant with the declared value.

Table 1: tolerances for foods including measurement uncertainty Tolerances for foods

(includes uncertainty of measurement) Vitamin C Other vitamins Minerals (for vitamins or minerals in food supplements according to 2002/46/EC see section 4; for vitamins or minerals added to foods according to 1925/2006/EC see section 5)

+80 -35% +50 -35% +45 -35%

Carbohydrate Sugars Protein Fibre Fat

<10 g per 100 g: ±2 g 10-40 g per 100 g: ±20% >40 g per 100 g: ±8 g <10 g per 100 g: ±1.5 g 10-40 g per 100 g: ±20% >40 g per 100 g: ±8 g

Saturates Mono-unsaturates Polyunsaturates

<4 g per 100 g: ±0.8 g ≥4g per 100 g: ±20%

Sodium Salt

<0.5 g per 100 g: ±0.15 g ≥0.5 g per 100 g: ±20% <1.25 g per 100 g: ±0.375 g ≥1.25 g per 100 g: ±20%

Example 1:

• A food product with a nutrition declaration of sugars of 8.5 g and no claim made about its sugar content

• According to the rounding guidelines of section 6 this equals to 8.45 to 8.54 g sugars /100 g • Lower tolerance: lower value (8.45) minus lower tolerance for sugars from section 3 which

is 2 g; 8.45 – 2 = 6.45 g/100 g; according to the rounding guidelines of section 6 the lower bound tolerance will be 6.5 g/100 g

• Upper tolerance: upper value (8.54) plus the upper tolerance for sugars from section 3 which is 2 g; 8.54 + 2 = 10.54 g/100 g; according to the rounding guidelines of section 6 the upper bound tolerance will be 11 g/100 g

• If official control finds a sugar content: - within the range of 6.5 to 11 g/100 g this product is found to be within the tolerance range according to the criteria laid down in section 3;

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- between the declared value (8.5 g) and the upper tolerance limit, control of compliance with section 2.3 should be considered - that is outside the range of 6.5 to 11 g/100 g, section 2.4 should be considered which gives examples of aspects to be taken into account when the measured value is outside the tolerance for the declared value

Example 2:

• A beverage with naturally occurring vitamin C and no claim about the vitamin C content • Nutrition declaration of the product: vitamin C: 12 mg/100 ml • According to the rounding rules of section 6 this equals to 11.5 to 12.4 mg vitamin C

/100ml • Lower tolerance: lower value (11.5) minus lower tolerance for vitamin C from section 3 which is 35%; (35% of 11.5 = 4.025 mg) = 7.475 mg/100 ml and according to the rounding guidelines of section 6 the lower bound tolerance will be 7.5 mg/100 ml

• Upper tolerance: upper value (12.4) plus the upper tolerance for vitamin C from section 3 which is 80% (80% of 12.4 = 9.92 mg) = 22.32 mg/100 ml and according to the rounding guidelines of section 6 the upper bound tolerance will be 22 mg/100 ml

• If official control finds a vitamin C content: - in the range of 7.5 to 22 mg/100 ml this product is found to be within the tolerance range according to the criteria laid down in section 3; - between the declared value and the lower tolerance range, control of compliance with section 2.3 should be considered;

• - that is outside the range of 7.5 to 22 mg/100 ml, section 2.4 should be considered which gives examples of aspects to be taken into account when the measured value is outside the tolerance for the declared value, such as particular high degradation rates of nutrients in some food matrices.

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4. TOLERANCES FOR VITAMINS AND MINERALS IN FOOD SUPPLEMENTS

Tolerance for vitamins and minerals in food supplements are set including all factors for variation: tolerance values listed include the uncertainty of measurement associated with a measured value. Therefore, no further allowance for measurement uncertainty has to be made when deciding whether a measured value is compliant with the declared value.

Table 2: Tolerances for food supplements including measurement uncertainty

Tolerances for supplements (includes uncertainty of measurement)

Vitamin C Other vitamins Minerals

+80 -20% +50 -20% +45 -20%

Example 3:

• A food supplement with a nutrition declaration of folic acid of 125 µg per unit and no claim made about its folic acid content

• According to the rounding guidelines of section 6 this equals to 124.5 to 125.4 µg folic acid per unit

• Lower tolerance: lower value (124.5) minus lower tolerance for vitamins from section 4 which is 20% (20 % of 124.5 = 24.9); 124.5 – 24.9 = 99.6 µg per unit and according to the rounding guidelines of section 6 the lower bound tolerance will be 99.6 µg per unit

• Upper tolerance: upper value (125.4) plus the upper tolerance for vitamins from section 4 which is 50% (50% of 125.4 = 62.7); 125.4 + 62.7 = 188.1 µg per unit and according to the rounding guidelines of section 6 the upper bound tolerance will be 188 µg per unit

• If official control finds a folic acid content: - in the range of 99.6 to 188 µg per unit, this product is found to be within the tolerance range according to the criteria laid down in section 4; - that is outside the range of 99.6 to 188 µg per unit, section 2.4 should be considered which gives examples of aspects to be taken into account when the measured value is outside the tolerance for the declared value.

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5. TOLERANCES FOR CONTROLLING THE COMPLIANCE OF LEVELS OF NUTRIENTS

AND OTHER SUBSTANCES WITH LEVELS SPECIFIED IN REGULATION 1924/2006/EC

AND FOR CONTROLLING THE LEVELS OF VITAMINS AND MINERALS WHEN ADDED TO

FOODS ACCORDING TO REGULATION 1925/2006/EC

This section applies to nutrients and other substances for which a nutrition or health claim is made according to Regulation 1924/2006/EC, and it applies to added vitamins and minerals according to Regulation 1925/2006/EC.

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OPTION A: Member States' control authorities measure the levels of nutrients and other substances in foods in order to control the compliance of products using nutrition or health claims with the levels of nutrients and other substances specified in the conditions of use for such claims. The conditions of use of nutrition claims are set in the Annex to Regulation (EC) No 1924/2006 on nutrition and health claims and the conditions of use of health claims are set in the implementing measures authorising health claims. Examples of such nutrient levels specified in the conditions of use of Regulation (EC) No 1924/2006 are the fat level for a 'low fat' claim, the vitamin or mineral level for a 'source of' claim or the levels specified for different substances in the conditions of use for health claims. In order to ensure that consumers are not misled by nutrition and health claims, especially when the claimed nutritional and/or physiological effect is achieved with a certain amount of a nutrient or other substance for which the claim is made, a tolerance that includes only the measurement uncertainty8 is applied to one side of the declared level of the nutrients or other substances in the conditions of use of the claim. To the other side of the declared levels a tolerance that is wider than the analytical uncertainty can be accepted. The levels of nutrients and other substances for the use of nutrition and health claims can be minimum or maximum levels. In case only a maximum but no minimum level is specified, for deviations to the maximum side only the measurement uncertainty is applied while deviations to the minimum side can be accepted within the tolerance range indicated in table 3.In case only a minimum but no maximum level is specified, for deviations to the minimum side only the measurement uncertainty is applied while deviations to the maximum side can be accepted within the upper tolerance range indicated in table 3. For vitamins and minerals, for deviations to the minimum side only the measurement uncertainty is applied, while deviations to the maximum side can be accepted within the upper tolerance range indicated in table 3; however, levels should not exceed maximum amounts for vitamins and minerals harmonised at EU level, according to the provisions in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and in Directive 2002/46/EC on food supplements. In the absence of harmonised rules on maximum amounts in foods and food supplements Member States may establish national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union. However, in doing so, they should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC. In case the tolerance range around a declared value extends above the maximum amount established by Member States as national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union, for which Member States should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC, the current practice of handling such issues before this guidance document was agreed may be maintained. All permitted nutrition and health claims with the conditions for their use are published in the Union Register of nutrition and health claims9. Furthermore, levels of vitamins and minerals added to foods as regulated by Regulation (EC) No 1925/2006/EC are measured by Member States' control authorities in order to control the compliance with levels of vitamins and minerals declared in the nutrition declaration. To the lower

8 Measurement uncertainty is determined for each analysed value.

9 http://ec.europa.eu/nuhclaims/ Mis en forme : Police :10 pt, Anglais(Royaume-Uni)

Mis en forme : Anglais (Royaume-Uni)

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side, meaning below the declared values of the vitamins or minerals added to foods, a tolerance that only includes the measurement uncertainty is applied, while above the declared values deviations from the declared value can be accepted within the upper tolerance indicated in table 3, but levels should not exceed maximum amounts for vitamins and minerals harmonised at EU level according to the provisions in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. In the absence of harmonised rules on maximum amounts in foods Member States may establish national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union. However, in doing so, they should also follow the criteria laid down in Regulation (EC) No 1925/2006. In case the tolerance range around a declared value extends above the maximum amount established by Member States as national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union, for which Member States should also follow the criteria laid down in Regulation (EC) No 1925/2006, the current practice of handling such issues before this guidance document was agreed may be maintained.

Table 3: tolerances for foods and food supplements for controlling the compliance of levels of nutrients and other substances with levels specified in Regulation 1924/2006/EC and for controlling the levels of vitamins and minerals when added to foods according to Regulation 1925/2006/EC Tolerances for foods and food supplements Vitamin C Other vitamins

Minerals

+80% – measurement uncertainty +50% – measurement uncertainty

+45% – measurement uncertainty Carbohydrate* Protein* Fibre*

Sugars*

Fat*

<10 g per 100 g: +4g – measurement uncertainty 10-40 g per 100 g: +40% – measurement uncertainty >40 g per 100 g: +16g – measurement uncertainty

<10 g per 100 g: -4g + measurement uncertainty 10-40 g per 100 g: -40% + measurement uncertainty >40 g per 100 g: -16g + measurement uncertainty

<10 g per 100 g: -3g + measurement uncertainty 10-40 g per 100 g: -40% + measurement uncertainty >40 g per 100 g: -16g + measurement uncertainty

Saturates* Mono-unsaturates* Polyunsaturates*

<4 g per 100 g: -1.6 g + measurement uncertainty ≥4g per 100 g: -40% + measurement uncertainty <4 g per 100 g: +1.6 g - measurement uncertainty ≥4g per 100 g: +40% - measurement uncertainty

Sodium

Salt

< 0.5 g per 100 g: -0.3 g + measurement uncertainty ≥0.5 g per 100 g: -40% + measurement uncertainty

<1.25 g per 100 g: -0.75 g + measurement uncertainty ≥1.25 g per 100 g: -40% + measurement uncertainty

*Not applicable to sub-categories

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Example 4: • A food product with added vitamin C and a claim 'source of vitamin C' that does not contain

naturally occurring vitamin C • Conditions of use for the claim: 15% of daily reference intake (80 mg) per 100 g

= 12 mg vitamin C/100 g • Nutrition declaration of the product: vitamin C: 12 mg/100 g • According to the rounding rules of section 6 this equals to 11.5 to 12.4 mg vitamin C /100g Case 1) Official control finds a vitamin C content of 9.6 mg/100 g, the associated measurement uncertainty is ± 1.92 mg/100 g (a specific measurement uncertainty of 20% is assumed for this analysis): this product is found to be within the tolerance range according to the criteria laid down in section 5 Case 2) Official control finds a vitamin C content of 9.5 mg ± 1.9 mg/100 g (a specific measurement uncertainty of 20 % is assumed for this analysis): the nutrient declaration is outside the lower tolerance range according to the criteria laid down in section 5 and section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value Case 3) Official control finds a vitamin C content of 18 mg/100 g which is within the upper tolerance range according to the criteria laid down in section 5; the upper tolerance equals the upper value (here 12.4 mg) plus the upper tolerance for vitamin C from table 3 which is 80%; 80 % of 12.4 = 9.92); 12.4 + 9.92 = 22.32 mg/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 22 mg/100 g Case 4) Official control finds a vitamin C content of 23 mg/100 g which is outside the upper tolerance range according to the criteria laid down in section 5 (see case 3); section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value

Example 5: • A food product with a 'reduced fat' claim, the fat content of the similar product is 40 g • Conditions of use for the claim: at least a 30% reduction of fat compared to a similar

product • Nutrition declaration of the product: fat: 28 g/100 g • According to the rounding rules of section 6 this equals to 27.5 to 28.4 g fat /100 g Case 1) Official control finds a fat content of 29 g/100 g, the associated measurement uncertainty is ± 0.87 g/100 g (a specific measurement uncertainty of ± 3 % is assumed for this analysis); this product is found to be within the tolerance range according to the criteria laid down in section 5 since the found value minus the associated measurement uncertainty is within the acceptable range of the declared value; 29 - 0.87 = 28.13 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 28 g/100 g Case 2) Official control finds a fat content of 30 ± 0.9 g/100 g (a specific measurement uncertainty of ± 3 % is assumed for this analysis); the nutrient declaration is outside the upper tolerance since the found value minus the associated measurement uncertainty is outside the acceptable range of the declared value: 30 – 0.9 = 29.1 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 29 g/100 g and section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value. Case 3) Official control finds a fat content of 20 g/100 g which is within the lower tolerance range according to the criteria laid down in section 5; the lower tolerance equals the lower value (here 27.5 g) minus (according to information provided in Table 3) 40 % of 27.5 which equals 11 g; 27.5 – 11 = 16.5 g/100 g, rounded to 17 g/100 g; Case 4) Official control finds a fat content of 16 g/100 g which is outside the lower tolerance range according to the criteria laid down in section 5 (see case 3); section 2.4 should be

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considered which gives examples of factors to be taken into account when the measured value outside the tolerance for the declared value.

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OPTION B: Member States' control authorities measure the levels of nutrients and other substances in foods in order to control the compliance of products using nutrition or health claims with the levels of nutrients and other substances specified in the conditions of use for such claims. The conditions of use of nutrition claims are set in the Annex to Regulation (EC) No 1924/2006 on nutrition and health claims and the conditions of use of health claims are set in the implementing measures authorising health claims. Examples of such nutrient levels specified in the conditions of use of Regulation (EC) No 1924/2006 are the fat level for a 'low fat' claim, the vitamin or mineral level for a 'source of' claim or the levels specified for different substances in the conditions of use for health claims. All permitted nutrition and health claims with the conditions for their use are published in the Union Register of nutrition and health claims10. Furthermore, levels of vitamins and minerals added to foods as regulated by Regulation (EC) No 1925/2006/EC are measured by Member States' control authorities in order to control the compliance with levels of vitamins and minerals declared in the nutrition declaration. Irrespective of whether the provisions under 5.1, 5.2, 5.3 or 5.4 are applied, levels should not exceed maximum amounts for vitamins and minerals harmonised at EU level, according to the provisions in Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods and in Directive 2002/46/EC on food supplements. In the absence of harmonised rules on maximum amounts in foods and food supplements Member States may establish national rules in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union. However, in doing so, they should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC. In case the tolerance range around a declared value extends above the maximum amount established by Member States as national rules, in compliance with Articles 34 and 36 of the Treaty on the Functioning of the European Union for which Member States should also follow the criteria laid down in Regulation (EC) No 1925/2006 and Directive 2002/46/EC, the current practice of handling such issues before this guidance document was agreed may be maintained. 5.1 The declared values for the nutrients or other substances for which claims are made are the same as the level of nutrients or other substances specified in the conditions of use for such claims or the declared values for the vitamins and minerals added to foods are the same as the minimum levels of the vitamins and minerals that are required to be present in the food according to the provisions in Regulation (EC) No 1925/2006 In order to ensure that consumers are not misled by nutrition and health claims, especially when the claimed nutritional and/or physiological effect is achieved with a certain amount of a nutrient or other substance for which the claim is made, a tolerance that includes only the measurement uncertainty11 is applied to one side of the declared level of the nutrients or other substances

10 http://ec.europa.eu/nuhclaims/

11 Measurement uncertainty is determined for each analysed value.

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specified in the conditions of use of the claim. To the other side of the declared levels a tolerance that is wider than the analytical uncertainty can be accepted. The levels of nutrients and other substances for the use of nutrition and health claims can be minimum or maximum levels. In case only a maximum but no minimum level is specified, for deviations to the maximum side only the measurement uncertainty is applied while deviations to the minimum side can be accepted within the tolerance range indicated in table 3 ('side 1 of tolerance' or 'side 2 of tolerance' respectively). In case only a minimum but no maximum level is specified, for deviations to the minimum side only the measurement uncertainty is applied while deviations to the maximum side can be accepted within the upper tolerance range indicated in table 3 ('side 1 of tolerance' or 'side 2 of tolerance' respectively). For vitamins and minerals, for deviations to the minimum side only the measurement uncertainty is applied, while deviations to the maximum side can be accepted within the upper tolerance range indicated in table 3 ('side 1 of tolerance' or 'side 2 of tolerance' respectively); Furthermore, levels of vitamins and minerals added to foods as regulated by Regulation (EC) No 1925/2006/EC are measured by Member States' control authorities in order to control the compliance with levels of vitamins and minerals declared in the nutrition declaration. To the lower side, meaning below the declared values of the vitamins or minerals added to foods, a tolerance that only includes the measurement uncertainty is applied, while above the declared values deviations from the declared value can be accepted within the upper tolerance indicated in table 3 ('side 1 of tolerance' or 'side 2 of tolerance' respectively).

Table 3: tolerances for foods and food supplements for controlling the compliance of levels of nutrients and other substances with levels specified in Regulation 1924/2006/EC and for controlling the levels of vitamins and minerals when added to foods according to Regulation 1925/2006/EC Tolerances for foods and food supplements

Side 1 of tolerance Side 2 of tolerance Vitamin C Other vitamins Minerals

+80% +50% +45%

– measurement uncertainty – measurement uncertainty – measurement uncertainty

Carbohydrate* Protein* Fibre* Sugars* Fat*

<10 g per 100 g: +4g 10-40 g per 100 g: +40% >40 g per 100 g: +16g <10 g per 100 g: -4g 10-40 g per 100 g: -40% >40 g per 100 g: -16g <10 g per 100 g: -3g 10-40 g per 100 g: -40% >40 g per 100 g: -16g

– measurement uncertainty – measurement uncertainty – measurement uncertainty + measurement uncertainty + measurement uncertainty + measurement uncertainty + measurement uncertainty + measurement uncertainty + measurement uncertainty

Saturates* Mono-unsaturates* Polyunsaturates*

<4 g per 100 g: -1.6 g ≥4g per 100 g: -40% <4 g per 100 g: +1.6 g ≥4g per 100 g: +40%

+ measurement uncertainty + measurement uncertainty - measurement uncertainty - measurement uncertainty

Sodium Salt

< 0.5 g per 100 g: -0.3 g ≥0.5 g per 100 g: -40% <1.25 g per 100 g: -0.75 g ≥1.25 g per 100 g: -40%

+ measurement uncertainty + measurement uncertainty + measurement uncertainty + measurement uncertainty


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Example 4:

• A food product with added vitamin C and a claim 'source of vitamin C' that does not contain naturally occurring vitamin C

• Conditions of use for the claim: 15% of daily reference intake (80 mg) per 100 g = 12 mg vitamin C/100 g

• Nutrition declaration of the product: vitamin C: 12 mg/100 g • According to the rounding rules of section 6 this equals to 11.5 to 12.4 mg vitamin C /100g Case 1) Official control finds a vitamin C content of 9.6 mg/100 g, the associated measurement uncertainty is ± 1.92 mg/100 g (a specific measurement uncertainty of 20% is assumed for this analysis): 9.6 + 1.92 = 11.52, the measurement uncertainty can explain that the value found is below the value declared; this product is found to be within the tolerance range according to the criteria laid down in section 5.1 Case 2) Official control finds a vitamin C content of 9.5 mg ± 1.9 mg/100 g (a specific measurement uncertainty of 20 % is assumed for this analysis): the nutrient declaration is outside the lower tolerance range according to the criteria laid down in section 5.1 and section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value. Case 3) Official control finds a vitamin C content of 18 mg/100 g which is within the upper tolerance range according to the criteria laid down in section 5.1; the upper tolerance equals the upper value (here 12.4 mg) plus the upper tolerance for vitamin C from table 3 which is 80%; 80 % of 12.4 = 9.92); 12.4 + 9.92 = 22.32 mg/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 22 mg/100 g Case 4) Official control finds a vitamin C content of 23 mg/100 g which is outside the upper tolerance range according to the criteria laid down in section 5.1 (see case 3); section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value

Example 5: • A food product with a 'reduced fat' claim, the fat content of the similar product is 40 g • Conditions of use for the claim: at least a 30% reduction of fat compared to a similar

product • Nutrition declaration of the product: fat: 28 g/100 g • According to the rounding rules of section 6 this equals to 27.5 to 28.4 g fat /100 g Case 1) Official control finds a fat content of 29 g/100 g, the associated measurement uncertainty is ± 0.87 g/100 g (a specific measurement uncertainty of ± 3 % is assumed for this analysis); this product is found to be within the tolerance range according to the criteria laid down in section 5 since the found value minus the associated measurement uncertainty is within the acceptable range of the declared value; 29 - 0.87 = 28.13 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 28 g/100 g Case 2) Official control finds a fat content of 30 ± 0.9 g/100 g (a specific measurement uncertainty of ± 3 % is assumed for this analysis); the nutrient declaration is outside the upper tolerance since the found value minus the associated measurement uncertainty is outside the acceptable range of the declared value: 30 – 0.9 = 29.1 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 29 g/100 g and section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value. Case 3) Official control finds a fat content of 20 g/100 g which is within the lower tolerance range according to the criteria laid down in section 5; the lower tolerance equals the lower value (here 27.5 g) minus (according to information provided in Table 3) 40 % of 27.5 which equals 11 g; 27.5 – 11 = 16.5 g/100 g, rounded to 17 g/100 g;

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Case 4) Official control finds a fat content of 16 g/100 g which is outside the lower tolerance range according to the criteria laid down in section 5 (see case 3); section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value.

5.2 The declared values for the nutrients or other substances for which claims are made are exceeding the minimum levels or are below the maximum levels specified in the conditions of use for such claims to an extent, that if the tolerances from table 1 are applied around these declared values, the overall tolerance range would not overlap with the levels of nutrients or other substances specified in the conditions of use for such claims or the declared values for the vitamins and minerals added to foods are exceeding the minimum levels of vitamins and minerals that are required to be present in the food according to the provisions in Regulation (EC) No 1925/2006 to an extent, that if the tolerances from table 1 are applied around these declared values, the overall tolerance range would not overlap with the minimum levels of vitamins and minerals that are required to be present in the food according to the provisions in Regulation (EC) No 1925/2006 In this case, the tolerance values from table 1 apply. Example 6:

• A food product with added vitamin C and no claim • Minimum amount of vitamin C to be provided in 100 g of the product: 15% of daily

reference intake (80 mg) per 100 g = 12 mg vitamin C/100 g • Nutrition declaration of the product: vitamin C: 24 mg/100 g • According to the rounding rules of section 6 this equals to 23.5 to 24.4 mg vitamin C /100g • If the tolerances for vitamin C from table 1 are applied (-35% +80%), this would lead to a

lower tolerance: lower value (23.5) minus 35%; (35% of 23.5 = 8.225 mg) = 15.275 mg/100 ml and according to the rounding guidelines of section 6 the lower bound tolerance will be 15 mg/100 ml; this value is above the minimum level required in the product (12 mg/100 g), therefore the provisions explained in 5.2 apply, the tolerances from table 1 are applied.

• Upper tolerance: upper value (24.4) plus the upper tolerance for vitamin C from table 1, section 3 which is 80% (80% of 24.4 = 19.52 mg) = 43.92 mg/100 ml and according to the rounding guidelines of section 6 the upper bound tolerance will be 44 mg/100 g

• If official control finds a vitamin C content: - in the range of 15 to 44 mg/100 g this product is found to be within the tolerance range according to the criteria laid down in 5.2; - between the declared value and the lower tolerance range, control of compliance with section 2.3 should be considered;

• - that is outside the range of 15 to 44 mg/100 ml, section 2.4 should be considered which gives examples of aspects to be taken into account when the measured value is outside the tolerance for the declared value.

5.3 The declared values for the nutrients or other substances for which claims are made are exceeding the minimum levels or are below the maximum levels specified in the conditions of use for such claims to an extent, that if the tolerances from table 1 are applied around these declared values, the overall tolerance range would overlap with the levels of nutrients or other substances specified in the conditions of use for such claims or

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the declared values for the vitamins and minerals added to foods are exceeding the minimum levels of vitamins and minerals that are required to be present in the food according to the provisions in Regulation (EC) No 1925/2006 to an extent, that if the tolerances from table 1 are applied around these declared values, the overall tolerance range would overlap with the minimum levels of vitamins and minerals that are required to be present in the food according to the provisions in Regulation (EC) No 1925/2006 In this case, if a nutrition and health claim is made for nutrients or other substances, a tolerance range of the overall magnitude specified under 'side 1 of tolerance' in table 3 is applied to the minimum levels or the maximum levels of the nutrients or other substances for which claims are made as specified in the conditions of use for such claims. For vitamins and minerals added to foods as regulated by Regulation (EC) No 1925/2006/EC, a tolerance range of the overall magnitude specified under 'side 1 of tolerance' in table 3 is applied to the minimum levels of the vitamins and minerals required to be present in the food according to the provisions in Regulation (EC) No 1925/2006, Example 7:

• A solid food product with a 'low in sugars' claim • Conditions of use for the claim: maximum 5 g of sugars per 100 g • Nutrition declaration of the product: sugars: 4.1 g/100 g • According to the rounding rules of section 6 this equals to 4.05 to 4.14 g sugars /100 g • If the tolerances for sugars from table 1 are applied (± 2 g), this would lead to an upper

tolerance: upper value (4.14) plus 2 g = 6.14 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 6.1 g/100 g; the tolerance range from table 1 would overlap with the maximum level of 5 g sugars per 100 g according to the conditions for the claim made. Therefore, the provisions explained in 5.3 apply, the overall magnitude specified in side 1 of tolerance table in table 3 (-4 g) is applied to the maximum level of sugars specified in the conditions for the claim (5 g). According to the rounding guidelines of section 6 the upper bound tolerance will be 5.0 g and the lower bound tolerance will be 1.0 g.

• If official control finds sugars content: • - in the range of 1.0 to 5.0 g/100 g this product is found to be within the tolerance range

according to the criteria laid down in 5.3; • - that is outside the range of 1.0 to 5.0 g/100 g, section 2.4 should be considered which

gives examples of aspects to be taken into account when the measured value is outside the tolerance for the declared value.

5.4 A claim is made for nutrients or other substances with specifying a level that exceeds the minimum levels or is below the maximum levels specified in the conditions of use for such claims In order to ensure that consumers are not misled by nutrition and health claims, in this case, the provisions of 5.1 apply.

Example 8:

• A food product with a claim 'high in fibre, contains 12 g of fibre per 100g', it contains only 2 g of fibre per 100 kcal

• Conditions of use for the claim: minimum 6 g of fibre / 100 g

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• Nutrition declaration of the product: fibre: 12 g/100 g • According to the rounding rules of section 6 this equals to 11.5 to 12.4 g fibre /100g • In the claim a level of fibre is specified that exceeds the minimum level specified in the

conditions of use for such a claim (6 g/100 g). Therefore, the provisions explained in 5.4 apply, which means 5.1 applies.

Case 1) Official control finds a fibre content of 9.6 g/100 g, the associated measurement uncertainty is ± 1.92 g/100 g (a specific measurement uncertainty of 20% is assumed for this analysis), 9.6 + 1.92 = 11.52 g, the measurement uncertainty can explain that the value found is below the value declared; this product is found to be within the tolerance range according to the criteria laid down in section 5.1 Case 2) Official control finds a fibre content of 8.1 g ± 1.62 g/100 g (a specific measurement uncertainty of 20 % is assumed for this analysis), 8.1 + 1.62 = 9.72 g: the nutrient declaration is outside the lower tolerance range according to the criteria laid down in section 5.1 and section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value. Case 3) Official control finds a fibre content of 14.5 g/100 g which is within the upper tolerance range according to the criteria laid down in section 5.1; the upper tolerance equals the upper value (here 12.4 mg) plus the upper tolerance for fibre from table 3 which is + 40% g; 40 % of 12.4 = 2.48); 12.4 + 2.48 = 14.88 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 15 g/100 g Case 4) Official control finds a fibre content of 18.1 g/100 g which is outside the upper tolerance range according to the criteria laid down in section 5.1 (see case 3); section 2.4 should be considered which gives examples of factors to be taken into account when the measured value is outside the tolerance for the declared value

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6. ROUNDING GUIDELINES FOR NUTRITION DECLARATIONS FOR FOODS Rounding guidelines are among the factors that influence the setting of tolerances, including the number of significant figures or decimal places in order not to imply a level of precision which is not true. The guidance on the rounding of the declared values should be taken into account when estimating whether the value that was determined during the analysis of the control authority is within tolerance limits.

For example, based on the rounding guidance, a declared value for protein of 12 g (no claim about protein made) could represent a value derived from calculation or analysis of between 13.4 g and 11.5g.

• The margins of tolerance should be applied to the upper and lower bounds of the values that could be rounded to the declared value, in this example 13.4g and 101.5 g.

• In this case the tolerance identified in section 3 would be ±20%, this gives a tolerance on the upper side calculated from 13.4g plus 20% making a total of 16.08g, rounded to 16g.

• If the analysed amount is found to be 16 g, this would be regarded as being within the tolerance, 17 g is not.

Another aspect of rounding rules are the amounts of nutrients which can be regarded as negligible and can be therefore declared as '0' or as '<x g' as indicated in table 4 giving values for 'x' for the specific nutrients. Alternatively, 'contains negligible amounts of …' could be labelled.

Table 4: Rounding guidelines for the nutrient declaration in nutrition labelling of foods

Nutritional element Amount Rounding Energy

to nearest 1 kJ/kcal (no decimals)

Fat*, Carbohydrate*, sugars*, Protein*, fibre*, polyols*, starch*

≥10 g per100 g or ml to nearest 1 g (no decimals) <10 g and > 0.5 g per 100 g or ml to nearest 0.1 g no detectable amounts is present or concentration is ≤ 0.5 g per 100 g or ml

“0 g” or "<0.5 g" may be declared

Saturates*, Mono-unsaturates* Polyunsaturates*

≥10 g per 100 g or ml to nearest 1 g (no decimals) <10 and > 0.1 g per 100 g or ml to nearest 0.1 g no detectable amounts is present or concentration is ≤ 0.1 g per 100 g or ml


Sodium ≥1 g per 100 g or ml to nearest 0.1 g <1 g and > 0.005 g per 100 g or ml to nearest to nearest 0.01 g no detectable amounts is present or concentration is ≤ 0.005 g per 100 g or ml


Salt ≥1 g per 100 g or ml to nearest 0.1 g <1 g and > 0.0125 g per 100 g or ml to nearest 0.01 g no detectable amounts is present or concentration is ≤ 0.0125 g per 100 g or ml

“0 g” or <0.01 g" may be declared

Vitamins and minerals vitamin A, folic acid, chloride, calcium, phosphorus, magnesium, iodine, potassium

3 significant figures

All other vitamins and minerals 2 significant figures


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7. TABLE 5: SUMMARY TABLE (ONLY OPTION A INCLUDED)

Tolerances for foods

including MU Tolerances

for supplements

including MU

Tolerances for Controlling Compliance of nutrients with Reg.

1924/2006/EC Reg. 1925/2006/EC in food or food

supplements

Rounding

Vitamin C Other vitamins Minerals

+80% -35% +50% -35% +45% -35%

+80% -20% +50% -20 % +45% -35%

+ 80% - MU + 50% - MU + 45% - MU

vitamin A, folic acid all other vitamins Cl, Ca, P, Mg, I, K all other minerals

2 significant figures 3 significant figures 2 significant figures 3 significant figures 2 significant figures

Protein* Carbohydrate* Fibre*

<10 g per 100 g: 10-40 g per 100 g: >40 g per 100 g: <10 g per 100 g:

(fat: 10-40 g per 100 g: >40 g per 100 g:

±2 g ±20% ±8 g ±2 g ±1.5 g) ±20% ±8 g

<10 g per 100 g: +4 g - MU 10-40 g per 100 g: +40% - MU >40 g per 100 g: +16 g - MU

≥10g /100g or ml <10g and > 0.5g /100g or ml no detectable amounts or ≤ 0.5 g /100 g or ml

to nearest 1 g to nearest 0.1 g “0 g” or "<0.5 g" may be declared

Sugars* Fat*

+ MU <10 g per 100 g: -4g (fat: -3 g) + MU 10-40 g per 100 g: -40% + MU >40 g per 100 g: -16 g

Saturates* <4 g per 100 g: ≥4g per 100 g:

±0.8 g ±20%

+ MU <4 g per 100 g: -1.6g + MU ≥4g per 100 g: -40%

≥10g/100g or ml <10 and > 0.1g /100g or ml no detectable amounts or ≤ 0.1 g /100 g or ml

to nearest 1 g to nearest 0.1 g “0 g” or "<0.1 g" may be declared

Monounsaturates*

Polyunsaturates* <4 g per 100 g: +1.6g - MU ≥4g per 100 g: +40% - MU

Sodium

< 0.5 g per 100 g: ≥0.5 g per 100 g:

±0.15 g ±20%

+ MU < 0.5 g per 100 g: -0.3g + MU ≥0.5 g per 100 g: -40%

≥1 g per 100 g or ml <1g and > 0.005 g /100 gorml no detectable amounts or ≤ 0.005 g /100 g or ml

to nearest 0.1 g to nearest 0.01 g “0 g” or "<0.01 g" may be declared

Salt <1.25 g per 100 g: ≥1.25 g per 100 g:

±0.375 g ±20%

+ MU <1.25 g per 100 g: -0.75g + MU ≥1.25 g per 100 g: -40%

≥1 g / 100 g or ml < 1 g and > 0.0125 g / 100 g or ml no detectable amounts or ≤ 0.0125 g /100 g or ml

to nearest 0.1 g to nearest 0.01 g “0 g” or <0.01 g" may be declared

Energy to nearest 1 kJ/kcal * not applicable to sub-categories MU: measurement uncertainty

1

Key Points relating to the third version of the Draft Commission Guidance on Setting of Tolerances for Nutrient Values Declared on a Label

On behalf of FoodDrinkEurope, AESGP, EHPM, ERNA

The organizations listed above in principle support the development of co-regulation as an effective way for addressing complex issues that require case-by-case interpretation, which is not feasible with prescriptive legislation. The guidance on the setting of tolerances and rounding rules is a good example of an area where guidance is more appropriate than legislation.

While we welcome the guidance we consider that the application of this document is also intrinsically linked to the proposal for the setting of maximum levels for foods and food supplements. Industry would therefore appreciate that both would enter into application at the same moment in order to avoid duplication of product reformulation and consequent important costs.

The third version of the guidance presents a number of improvements, in particular listing a number of elements to be considered by enforcement authorities as a basis for discussion in case the proposed values are not met.

However, the draft document as it currently stands is complex and will result into higher economic costs, both for food operators as well as for enforcement authorities. In this respect, we would ask that the following 3 key points are carefully considered by EU decision-makers before this guidance document is finalized and adopted by the Standing Committee still this year:

Transition period and need for testing the proposed approach

The aim of the transition period is to allow food operators and enforcement authorities to prepare to apply the new values.

- This transition period should be sufficiently long to enable product adaptation and stability testing to be carried out where required. This is justified since the tight values proposed are new and may require additional product development work.

- Stocks of non-conforming products produced before the end of this transition period should be able to continue to be sold until the end of their shelf life. This is justified because such products are in conformity with current applicable legislation.

- The transition period should be preceded by a testing phase, during which the proposal can be properly assessed. In particular testing phase is crucial in order to identify particular situations where the measured value is recurrently outside the proposed tolerance range. This is justified because the values proposed deviate from current practice and have not been tested as to their feasibility. A testing period of 2 years seems adequate.

Technique

Zone de texte

ANNEXE III

2

The guidance should include a commitment for a regular review of the guidance, taking into consideration progressive experience gained by national enforcement authorities and food operators.

The recognition of specific nutrient cases

This version of the guidance has only recognized that a broader range is necessary for Vitamin C because of its inherent instability. This is required also for other nutrients that are less stable, including Vitamin B12, Vitamin D, Folic Acid, Vitamin B1, Pantothenic acid, Vitamin A and for the use of trace elements added in low quantities to foods. Therefore, we think it is important to revert back to the proposals for tolerances made by our organisations (see attached), which are based on practical experience. We also stress the importance of strengthening paragraph 2.4 of the guidance to avoid strict enforcement and ultimately fines from control authorities in case of unconformities.

One simple set of tolerances for all application

The proposal foresees two sets of requirements, depending on whether a claim is being made or not. We believe that this is needlessly complicated as the factors affecting tolerances are identical in both situations. Most fortified foods and food supplements are bearing a nutrition or health claim, which means that restrictive tolerances would apply, making compliance more difficult to be achieved.

A pragmatic approach would be to have one single set of tolerances for any nutrient or substance present in the food, whether naturally present, voluntarily or mandatorily added, and irrespective of claims made. These tolerances would need to be based on the legal concept of ‘average’ value and be simple and able to be handled by software currently applied.

We feel the above elements are critical to help food operators, in particular SMEs to apply this guidance and avoid unnecessary burden of cost in the current economic context.

October 2012

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Circ FEDALIM 44 12 tolerances declaration nutritionnelledoc.fedalim.com/FEDALIM/Circ_FEDALIM_44_12_tolerances_declaration... · l’ERNA2 et de l’AESGP3 sur les tolérances, qui