Codesoft Nutrition Labelling Software For Sandwiches

Nutrition Labelling Software

£465.00

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Product Description

Nutrition Labelling Software

Nutrition Labelling Software will work with any labelling package that can use a database for label printing. The main software labelling programs it works with are LabelDirect Pro, Bartender, Nicelabel and EnLabel. 

We can provide these programs either in their own right as individual programs or bundled together with Nutrition Manager.  Nutrition Manager is a Plugin Program for use alongside the labelling software mentioned allowing users to easily create and maintain a database of ingredients, products and all associated data. It includes full Nutritional and Allergen features to meet the requirements of EU legislation. Allergens must be put onto labels now (from Dec 15) and Nutritional data requirements comes into legislation this year, 13 December 2016.

A Government researched list of nutrition information is provided with this application, but the responsibility of maintaining this list and the data created with it lies solely with the user of this application. It is very easy to use and it performs Nutitional calculations and once a food ingredient is added to the database it is there for ongoing use for all products that will contain it.

Ingredients and Products List

Nutrition Manager meets all EU legislation requirements.

QUID

The EU 1169/2011 regulations require that the ingredients are posted on your product in quantitative order (Quantitative Ingredient Declaration – QUID). This information is dependent upon your recipe and Nutrition Manager is designed to deal with this automatically. Nutrition Labelling Software will perform this task for you once the product ‘recipe’ has been created.

When you prepare your recipe, Nutrition Manager calculates and re-orders the constituent ingredients into weight order and assigns a percentage for you. There is no effort on your part and the exported data comes in that sequence for use with your labelling software.

 

Easily add, edit and delete ingredients in Nutrition Manager and then compile multiple ingredients together to create individual ‘recipes’ for your products.

Ingredient Editor

 

Products will show the full breakdown of ingredients, allergens and nutritional information.

Product Editor

 

The full product information can then be exported to the labelling software LabelDirect etc. to be printed.

Label Data

 

If you have any questions about Nutrition Manager please contact us and we will do our best to get an answer for you. Our number is 01634 369027 and our email address is sales@printonlabels.co.uk.

NB: The following information is provided for guidance only and although copied direct from the UK Government website, Print On Labels Ltd cannot be held responsible for any errors whatsoever regarding the information provided. Clicking on certain links below will take you to the UK Government website for Food Safety etc.

Producing and distributing food – guidance

Food labelling: giving food information to consumers

Find out the information you must give to customers on food products and how to give it.

This guidance tells you the information you must provide with food products to comply with the European Food Information to Consumers Regulation No 1169/2011 (FIC) and the Food Information Regulations 2014 (FIR).

These rules apply to you if you operate a food business, even if you give food to consumers for free. You don’t need to give food information to customers if you’re not a food business and you’re providing food for an occasional event, like a village fair.

Labelling loose foods and foods pre-packed for direct sale

Loose (also called non pre-packed) foods are:

  • foods served at restaurants and canteens
  • takeaway foods that are placed into containers and sold at the same premises
  • any foods sold loose, eg meat or cheese at a deli counter, unpackaged bread or pick and mix sweets (including individually wrapped sweets)

Foods ‘pre-packed for direct sale’ are foods that you package and then sell on the same premises or local sites trading under the same name (eg sandwiches or salad boxes).

Information you must give

You must show the following information on a label on the food or display it clearly where the food is put on sale:

  • the name of the food
  • any allergenic ingredients in the food
  • the quantitative ingredients declaration (QUID) on products containing meat

If you’re a mass caterer, providing the information on a menu, you only need to provide allergen information.

You don’t need to provide further information on loose food or food that is pre-packed for direct sale. However, you must follow the rules for pre-packed foods for any information you give voluntarily (eg an ingredients list or a ‘use by’ date).

Labelling pre-packed food

Pre-packed food is any food that’s put into packaging before being put on sale and that cannot be altered without opening or changing the packaging.

Information to display on labels or packaging

You must display the following information (mandatory information) on the product packaging or on a label attached to the packaging:

  • the name of the food
  • the quantitative ingredients declaration (QUID) (where needed)
  • a list of ingredients (including allergens)
  • the weight or volume of the food (net quantity)
  • a ‘best before’ or ‘use by’ date
  • the name and address of the food business operator (FBO) responsible for the food information
  • the alcoholic strength by volume (as a percentage) on drinks containing over 1.2% alcohol by volume

How to display information on labels or packaging

Information on labels must be difficult to remove (indelible).

Your labelling must allow the customer to see all the following information at the same time (it must be on one side of the packaging):

  • the name of the food
  • the net quantity of the food
  • alcoholic strength by volume (for drinks containing over 1.2% alcohol)

You must print all the mandatory information using a font with a minimum x-height of 1.2 millimetres.

picture showing the x-height of a font
The x-height (6) must be 1.2 millimetres

If the largest surface area of packaging is less than 80cm squared, you can use a minimum x-height of 0.9mm.

Naming the food product

You must display a legal name for your food product. The legal name is different to the marketing name. It must not mislead the consumer.

Foods names that are laid down by law

Some types of food product have legal names that you must use if the product meets certain standards (for example, jam).

Some food names are registered on the EU protected food name register. You can’t use these names unless your product meets the specifications for the name.

Customary and descriptive food names

For a food product that doesn’t already have a legal name, you can use a customary name or a descriptive name.

A customary name is one that consumers in the UK generally accept as the name of the food without it needing further explanation (eg ‘toad-in-the-hole’ or ‘bakewell tart’).

A descriptive name says what the product is (eg ‘macaroni in a cheese sauce’).

If you’ve used a different ingredient to those that consumers expect to be in a product, you must state this as part of the name or close to the name on any label.

For example, the food could be called ‘parsley pesto sauce’ or ‘made with parsley’ could appear next to or directly under the name, where parsley has been used instead of the traditional basil.

You must give this information using a font that is at least 75% of the height of the food name and has an x-height of at least 1.2 mm.

Freezing and other treatments

You must tell the consumer if a food has been treated or is in a physical form that they should know about when buying it, so that they are not likely to be mislead (eg if it is ground, powdered, refrozen, freeze-dried, quick-frozen, concentrated or smoked).

If a food has been frozen, defrosted and then put on sale, you may need to tell consumers this by using the word ‘defrosted’.

You don’t need to tell the consumer if the food had to be frozen as part of a production process. For example, you don’t need to say when food has been temporarily frozen either:

  • to control parasites (in complying with food hygiene regulations)
  • so that it can be sliced very thinly

You don’t need to label a product as ‘defrosted’ if only certain ingredients in the final product were frozen or if the defrosting doesn’t have a negative effect on the safety or quality of the food.

Give information of freezing and other treatments either:

  • as part of the name
  • close to the name on the label (eg next to or directly underneath it)

Label foods treated with ionising radiation with the words ‘irradiated’ or ‘treated with ionising radiation’.

When you must add further information on some pre-packed products

State a product’s country of origin or place of provenance on the label if the words or pictures on the packaging imply that it comes from somewhere else. For example, if a food has a tartan wrapper but wasn’t made in Scotland, you need to put the actual country of origin on the label.

The ‘country of origin’ tells the consumer the country in which the food was produced. The ‘place of provenance’ may be a group of countries or a region within a country.

Describe on the label any special storage conditions or instructions if consumers will need them to use the food appropriately. For example, a product may need the words ‘keep refrigerated and use within 3 days of opening’ or ‘do not reheat’.

If a product has been packaged in a protective atmosphere, include the words ‘packaged in a protective atmosphere’ on the label or packaging.

Allergen labelling

You must provide information on allergens in food. This includes substances produced or derived from allergens or used in processing the food.

Allergens are:

  • cereals containing gluten, eg wheat (including spelt and khorasan wheat), rye, barley and oats
  • crustaceans, eg prawns, crabs, lobster, crayfish
  • eggs
  • fish
  • peanuts
  • soybeans
  • milk (including lactose)
  • nuts (ie almonds, hazelnuts, pistachio nuts, pecan nuts, walnuts, Brazil nuts and macadamia or Queensland nuts)
  • celery (including celeriac)
  • mustard
  • sesame seeds
  • sulphur dioxide/sulphites, if they are more than 10 milligrams per kilogram or 10 milligrams per litre in the finished product
  • lupin, including lupin seeds and flour
  • molluscs, eg mussels, oysters, snails and squid

Read the full guidance on food allergen labelling.

Listing the ingredients

You must put a list of ingredients (including information on additives) on the packaging of all pre-packed products except:

  • fresh fruit and vegetables that haven’t been peeled, cut or similarly treated
  • carbonated water that is labelled as ‘carbonated water’
  • fermented vinegars derived from single, basic product (eg white wine) with no added ingredients
  • cheese, butter, fermented milk or cream if its only ingredients are lactic products, food enzymes and micro-organism cultures essential to its manufacture
  • products consisting of a single ingredient where the name of the food is the same as the name of the ingredient or clearly identifies what the ingredient is (eg peanuts or eggs)
  • products on which no side of the packaging or container has a surface area larger than 10cm squared
  • products in glass bottles for reuse that have food information indelibly marked on them and have no other labelling (eg milk bottles)
  • any alcoholic drink containing over 1.2% alcohol by volume

You must put the ingredients list under a heading that contains the word ‘ingredients’.

If you’re not sure whether your particular food product is exempt from needing an ingredients list, contact your local trading standards office.

The name of ingredients should follow the rules set out for the name of the food. For example, you must only call an ingredient ‘jam’ if it meets the compositional standards for jam.

You must list the ingredients by weight from the most to the least that your product contains (based on the ingredient weights at the time of manufacture).

Other information in the ingredients list

Put ‘(nano)’ after the name of any engineered nanomaterial used as an ingredient.

Label foods treated with ionising radiation with the words ‘irradiated’ or ‘treated with ionising radiation’.

You must also show if an ingredient has been irradiated, even if it’s a compound ingredient (eg cheese) which has had one of its constituent parts irradiated (eg the milk used to make the cheese).

Giving a quantitative ingredients declaration (QUID)

The QUID tells a customer the percentage of particular ingredients contained in a food product.

When to display the QUID

You must show a QUID if the ingredient:

  • is in the name of the food (eg the ‘blackberry’ and ‘apple’ in a blackberry and apple pie)
  • is usually associated with that name by the consumer (‘mutton’ in a Lancashire hotpot)
  • is emphasised by words, pictures or graphics on the label (eg if there is a picture of blackberries on the label)
  • characterises a food and distinguishes it from products with a similar name or appearance

For example, lasagne made with pork must show the QUID for the pork because it characterises the product and distinguishes it from a lasagne (usually made with beef).

However, you don’t need to give a QUID if the ingredients:

  • have only been used in small quantities as flavouring
  • are used in varying proportions and can be labelled as fruit, vegetables, mushrooms, herbs or spices (eg in a vegetable soup)
  • already have a quantity shown on the label as a ‘drained net weight’

You don’t need a QUID for ingredients that can vary in quantity without altering the character of the food or distinguishing it from similar foods. For example, you don’t need to show a QUID for flour in a flour tortilla.

You must give the meat QUID when you sell loose or pre-packed-for-direct-sale products that contain meat and other ingredients (except in a catering environment). You must display the QUID on a label on the food or display it clearly where the customer can see it when they are choosing the product.

On pre-packed food, you must give this information either:

  • as a percentage in brackets in the ingredients list after the name of the ingredient, eg ‘pork (80%)’
  • in or next to the name of the food, eg ‘containing 80% pork’

Showing the ‘best before’ or ‘use by’ date

You must usually show either a ‘best before’ or a ‘use by’ date on the packaging or label of pre-packed food products.

Only show a ‘use by’ date where there is a safety issue with eating the food after this date. It’s a criminal offence to sell food that’s past its ‘use by’ date.

Read further guidance on date marking

You don’t need to show a ‘best before’ or ‘use by’ date, but you must include a lot number on:

  • fresh fruit and vegetables which haven’t been peeled, cut or similarly treated (except for sprouting seeds and similar products, like legume sprouts)
  • wines, liqueur wines, sparkling wines, aromatised wines and similar products made from fruit other than grapes
  • drinks made from fermented grapes or grape musts
  • drinks containing 10% or more alcohol by volume
  • baked or pastry goods which are normally consumed within 24 hours of being made
  • vinegar
  • cooking salt
  • solid sugar
  • confectionery made almost solely of flavoured or coloured sugars
  • chewing gums and similar chewing products

If you’re not sure whether your particular food product is exempt from showing a date of minimum durability, contact your local trading standards office.

Showing the name and address of the food business operator

You must include a business name and address on the packaging or food label of pre-packed food products. This must be either:

  • the name of the business whose name the food is marketed under, if based in the EU
  • the address in the EU of the business that has imported the food from outside the EU

The address needs to be a physical address within the EU where your business can be contacted by mail. You can’t use an e-mail address or phone number.

Nutritional labelling

You must label pre-packed food products with nutritional information if:

  • you make a nutritional or health claim on the packaging (eg ‘high in fibre’ or ‘good source of calcium’)
  • vitamins or minerals have been added to the food

You can choose to provide nutrition information on other food products.

When you provide nutrition information, you must follow the guidance on nutrition labelling.

Nutrition labelling will be compulsory on most pre-packed foods from December 2016.

Labelling meat and fish products

Types of meat and fish products

‘Fresh meat’ is meat that has not undergone any preserving process other than chilling or freezing. It includes meat that is vacuum wrapped or wrapped in a controlled atmosphere.

‘Meat preparations’ are foods made from fresh meat without changing the structure of the muscle fibre that characterises fresh meat. Other foods, seasonings and additives may have been added to them.

Meat is considered a ‘meat product’ if it’s made from meat or processed meat and no longer shows the structure of muscle fibre when cut.

‘Fishery products’ are food products that contain animals or products of animals (eg fish eggs) taken from freshwater or seawater. They don’t include products containing mammals, frogs or reptiles.

Products with added water

You must tell the consumer if your product contains added water that makes up more than 5% of its weight and it’s either:

  • a meat product or preparation that looks like a cut, joint, slice, portion or carcase
  • a fishery product that looks like a cut, joint, slice, portion, fillet or whole fishery product

This doesn’t apply to products like sausages or fish fingers because they don’t look like cuts or joints.

You must include the information with the name of the food (eg ‘ham with added water’).

Formed foods

You must put the words ‘formed meat’ or ‘formed fish’ next to the name of your product if it looks like a whole piece of meat or fish but is made up of 2 or more separate pieces.

Added proteins

You must include in the name of the food the name and origin of any protein you add to meat products, meat preparations and fishery products if the protein comes from a different species.

You need to do this wherever the protein is used as an ingredient including if you add hydrolysed proteins like:

  • albumin
  • collagen
  • casein
  • milk protein
  • egg protein

For example, your product could be named ‘chicken breast with added pork protein’, or ‘pork escalope with chicken protein’.

Minced meat

Minced meat should meet certain standards for fat content and the ratio of collagen to meat protein that it contains.

fat content must be the same or less than collagen to meat protein ratio must be the same or less than
Lean minced meat 7% 12%
Minced pure beef 20% 15%
Minced meat containing pork 30% 18%
Other minced meats 25% 15%

You can sell minced meat that doesn’t meet these criteria if the label includes a national mark, which is a printed square (□) followed by the words ‘For UK market only’.

Your label must always show the maximum percentage of fat and the collagen to meat protein ratio. Use the words ‘percentage of fat content under …’ and ‘collagen/meat protein ratio under …’.

Date of freezing

You must show the date of freezing or first freezing (for products that have been frozen more than once) on:

  • frozen meat
  • frozen meat preparations
  • frozen, unprocessed fisheries products

Use the words ‘frozen on’ and give the date on which the food was first frozen.

Country of origin

Any fresh, frozen or unprocessed meat from pigs, sheep, goats and poultry must show:

  • the country in which the meat was reared, using the words ‘reared in …’
  • the country in which the meat was slaughtered, using the words ‘slaughtered in …’

This meat must also have a batch code on the label to identify it.

Informing the consumer about certain ingredients

Sweeteners and sugars

You must put the words, ‘with sweetener(s)’ by the name of food products containing sweeteners

You must put the words, ‘with sugar(s) and sweetener(s)’ by the name of food products containing both sugars and sweeteners.

Aspartame and colourings

To comply with the rules on labelling additives, you must put the following warnings on the label if the product contains aspartame:

  • ‘contains a source of phenylalanine’, if aspartame is named in the ingredients list
  • ‘contains aspartame (a source of phenylalanine)’ if you use the E number (E951) instead of the name in the ingredients list

Liquorice

You must tell the consumer if a product contains glycyrrhizinic acid, its ammonium salt or the liquorice plant (Glycyrrhiza glabra). Put the following words immediately after the ingredients list (or by the name of the food if there is no ingredients list):

  • ‘contains liquorice’ on confectionary or drinks that contain 100 milligrams per kilogram or 10 milligrams per litre or more (unless you have named liquorice as an ingredient)
  • ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’ on confectionery that contains 4 grams per kilogram or more
  • ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’ on drinks that contain 50 milligrams per litre or more (or 300 milligrams per litre if it also contains more than 1.2% alcohol by volume)

Caffeine

You must label drinks that contain more than 150 milligrams per litre of caffeine with the words ‘High caffeine content. Not recommended for children or pregnant or breast-feeding women’.

This also applies to concentrated or dried drinks that will contain more than 150 milligrams per litre of caffeine when reconstituted. It doesn’t apply to tea and coffee drinks if ‘tea’ or ‘coffee’ are in the name of the food.

Where caffeine has been added to a food product (other than a drink) for a physiological purpose, you must put the words ‘Contains caffeine. Not recommended for children or pregnant women’ on the label.

You must put these warnings in the same field of vision as the name of the food and include the caffeine content in milligrams per 100 grams or per 100 millilitres in brackets after the warning.

Polyols

You must label foods that contain more than 10% added polyols with the words ‘excessive consumption may produce laxative effects’.

Plant sterols and stanols

You must label foods with added phytosterols, phytosterol esters, phytostanols or phytostanol esters with all of the following:

  • ‘with added plant sterols’ or ‘with added plant stanols’ (in the same field of vision as the name of the food)
  • a statement that the food is intended exclusively for people who want to lower their blood cholesterol level, and a statement that the consumption of more than 3 g/day of added plant sterols/plant stanols should be avoided (both in the same field of vision on the packaging)
  • a statement that patients on cholesterol lowering medication should only consume the product under medical supervision
  • an easily visible statement that the food may not be nutritionally appropriate for pregnant or breastfeeding women and children under the age of 5
  • advice that the food is to be used as part of a balanced and varied diet, including regular consumption of fruit and vegetables to help maintain carotenoid levels
  • a definition of a portion of the food or food ingredient along with with the amount of the plant sterol/plant stanol that each portion contains

You must put the amount of added phytosterols, phytosterol esters, phytostanols or phytostanol esters the food contains in the list of ingredients (as a percentage or the number of grams of free plant sterols/plant stanols per 100 g or 100 ml).

Distance selling

If you sell food products online or by phone or mail order, you must make the required information available for free to the customer before they buy (except the durability and freezing dates) and when it is delivered to them.

Selling food products to other businesses

You must pass on certain information about products if you are an FBO selling food products to other businesses, not to the final consumer. At the end of the supply chain, whoever is selling a food product to the final consumer must have all the information they need to provide.

Information you must provide

If the food will be sold non pre-packed to the final consumer, you must provide all the information required for non pre-packed foods.

If the food will be sold pre-packed to the final consumer, you must provide all information required for pre-packed food. This applies even if the pre-packing will be done by someone else after you sell it.

If you don’t know how the food will be sold to the final consumer, you should assume that it will be pre-packed.

How to provide information

You must provide the information on the pre-packaging if the packaging will not be changed before the product is sold to the final consumer.

If you’re not responsible for the final pre-packaging of the product or it is non pre-packed, you must provide the information either:

  • on pre-packaging
  • on a label attached to the pre-packaging
  • in the commercial documents associated with the food

You must send your customer the commercial documents before or at the same time as you send them the food.

Food in external packaging

You must also put extra information on any external packaging that you use to supply food that meets either of the following conditions:

  • it’ll be taken out of your external packaging and sold in its own packaging (eg a large box containing bags of potato crisps)
  • it’ll be used by a mass caterer to prepare food or it’ll be split or cut up

You must label your external packaging with:

  • the name of the food
  • the ‘best before’ or ‘use by’ date
  • any special storage conditions
  • the name and address of your business

Voluntary information

Some businesses that you sell to may ask you for additional, voluntary labelling information.

Improvement notices

In most cases, an officer from your local authority may issue you with an improvement notice if you haven’t complied with food regulations.Improvement notices can’t be issued in relation to net weight contraventions, but you can be prosecuted if you break net weight rules.

You’re committing an offence and may be prosecuted if you don’t comply with an improvement notice.

You may be prosecuted (without first being given an improvement notice) if you break the rules on allergens.

An improvement notice will tell you what your business is doing wrong, what rules have been broken, how to comply and by when. It will also tell you how to appeal against an improvement notice.

You can continue to operate if you get an improvement notice, but you must do what it tells you to do within the time it specifies.

Further information

If you’re a business and want advice on labelling, contact your local trading standards office.

This guidance is for the rules in the FIC and FIR. Other rules also apply to food labelling and composition.

You can learn about how to label your food products by completing a free online food labelling e-training course

Legislation

European Food Information to Consumers Regulation No 1169/2011     See below

Food Information Regulations 2014

Food information to consumers – EU legislation

New EU law on food information to consumers

The new Regulation (EU) No 1169/2011 on the provision of food information to consumers entered into application on 13 December 2014. The obligation to provide nutrition information will apply from 13 December 2016.

The new law combines 2 Directives into one legislation:

EUROPEAN COMMISSION

HEALTH AND CONSUMERS DIRECTORATE-GENERAL

December 2012

 

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

 

  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 services 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 authorities, 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 rules1 (hereinafter: Regulation (EC) No 882/2004). 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. 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 future modifications of the guidance document. Stakeholders will be consulted accordingly.

 

The Commission recommends that a pragmatic and proportionate 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 a smooth transition applies which should end at the latest on 13 December 2014. Economic operators should be informed 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 consumers2; Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs3; 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 supplements4.

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 and minerals and of certain other substances to foods5 and No 1924/2006 of the European Parliament and of the Council of 20

 

 

 

 

 

1  OJ L 165, 30.4.2004, p. 1–141

2  OJ L 304, 22.11.2011, p. 18

3  OJ L 276, 6.10.1990, p. 40

4  OJ L 183, 12.7.2002, p. 51

 

December 2006 on nutrition and health claims made on foods6. 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 uses7

 

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

 

Article 17 of 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 safety8 (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 Regulation (EC) No 882/2004 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 that 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;
  • 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.

 

 

 

 

OJ L 404, 30.12.2006, p. 9

7  OJ L 124, 20.5.2009, p. 21

 

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:

  1. the manufacturer’s analysis of the food;
  2. a calculation from the known or actual average values of the ingredients used;
  3. a calculation from generally established and accepted

 

  1. 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 is to 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.

 

As soon as harmonised rules on maximum amounts in foods and food supplements for vitamins and  minerals have been established in the EU legislation, it should be considered whether this guidance document needs to be revised.

 

 

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 of this guidance

 

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

 

  1. the manufacturer’s analysis of the food;
  2. a calculation from the known or actual average values of the ingredients used; or
  3. a calculation from generally established and accepted

 

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 should 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:

  1. the nutrient in question
  2. the extent of the deviation
  3. the nature of the deviation (overestimation or underestimation) in relation to the nutrient concerned
  4. natural high variation of the nutrient, including seasonality
  5. particular high degradation rates of nutrients in some food matrices
  6. particular high analytical variability of nutrients in a specific food matrix
  7. 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
  8. compliance of the majority of samples from the lot with the tolerance range, if such data is available
  9. validity of the manufacturer’s process for establishing the declared nutrient value
  10. how the self-monitoring of the company functions in general
  11. 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.

 

  1. TOLERANCES FOR THE NUTRITION DECLARATION ON FOODS OTHER THAN FOOD SUPPLEMENTS

For the nutrition declaration of nutrients for which a nutrition or health claim is made according to Regulation 1924/2006/EC, as well as for added vitamins and minerals according to Regulation 1925/2006/EC different tolerances may apply which are specified in section 5.

 

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 other than food supplements including measurement uncertainty

 

Tolerances for foods

(includes uncertainty of measurement)

Vitamins +50%**            -35%
Minerals +45%               -35%
Carbohydrate, Sugars, Protein,

Fibre

<10 g per 100 g:

10-40 g per 100 g:

>40 g per 100 g:

±2 g

±20%

±8 g

Fat <10 g per 100 g:

10-40 g per 100 g:

>40 g per 100 g:

±1.5 g

±20%

±8 g

Saturates,

Mono-unsaturates, Polyunsaturates

<4 g per 100 g:

≥4g per 100 g:

±0.8 g

±20%

Sodium <0.5 g per 100 g:

≥0.5 g per 100 g:

±0.15 g

±20%

Salt  

<1.25 g per 100 g:

≥1.25 g per 100 g:

 

±0.375 g

±20%

** for vitamin C in liquids, higher upper tolerance values could be accepted

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 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;
    • 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

 

 

 

  1. 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)

Vitamins +50%**            -20%
Minerals +45%               -20%

** for vitamin C in liquids, higher upper tolerance values could be accepted

 

 

Example 2:

  • 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 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.

 

  1. 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.

 

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 Annex to 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 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.

 

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 uncertainty10 is applied to one side of the declared level of the nutrients or other substances specified in the conditions of use of the claim. To the other side of the declared levels a tolerance that is wider than the measurement uncertainty can be

 

 

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

 

10     Measurement uncertainty is determined for each analysed value

 

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), below. 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’); 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’).

 

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

(includes uncertainty of measurement to the side  specified, + or -)

Side 2 of tolerance
Vitamins +50%** – measurement uncertainty
Minerals +45% – measurement uncertainty
Carbohydrate*, Protein*, Fibre* <10 g per 100 g:          +4g

10-40 g per 100 g:        +40%

>40 g per 100 g:          +16g

–  measurement uncertainty

–  measurement uncertainty

–  measurement uncertainty

Sugars* <10 g per 100 g:          -4g

10-40 g per 100 g:        -40%

>40 g per 100 g:          -16g

+ measurement uncertainty

+ measurement uncertainty

+ measurement uncertainty

Fat* <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

Saturates* <4 g per 100 g:            -1.6 g

≥4g per 100 g:             -40%

+ measurement uncertainty

+ measurement uncertainty

Mono-unsaturates*, Polyunsaturates* <4 g per 100 g:            +1.6 g

≥4g per 100 g:             +40%

–  measurement uncertainty

–  measurement uncertainty

Sodium < 0.5 g per 100 g:        -0.3 g

≥0.5 g per 100 g:         -40%

+ measurement uncertainty

+ measurement uncertainty

Salt <1.25 g per 100 g:        -0.75 g

≥1.25 g per 100 g:        -40%

+ measurement uncertainty

+ measurement uncertainty

*Not applicable to sub-categories

** for vitamin C in liquids, higher upper tolerance values could be accepted

 

Example 3:

  • 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 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; 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 value 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 17 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 50%; (50 % of 12.4 = 6.2); 12.4  +

 

6.2 = 18.6 mg/100 g and according to the rounding guidelines of section 6 the upper bound tolerance  will be 19 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 4:

  • 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 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 value 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 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 exceed 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 (for foods other than food supplements) or table 2 (for food supplements) 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 exceed 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 for foods other than food supplements and the tolerance values from table 2 for food supplements apply.

 

Example 5:

  • 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 5 to 24.4 mg vitamin C /100g
  • If the tolerances for vitamin C from table 1 are applied (-35% +50%), this would lead to a lower tolerance: lower value (23.5) minus 35%; (35% of 23.5 = 8.225 mg) = 15.275 mg/100 g and according to the rounding guidelines of section 6 the lower bound tolerance will be 15 mg/100 g; 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
  • Upper tolerance: upper value (24.4) plus the upper tolerance for vitamin C from table 1, section 3 which is 50% (50% of 24.4 = 12.2 mg) = 36.6 mg/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 37 mg/100 g
  • If official control finds a vitamin C content:
    • in the range of 15 to 37 mg/100 g this product is found to be within the tolerance range according to the criteria laid down in 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 37 mg/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.

 

 

5.3   The declared values for the nutrients or other substances for which claims are made exceed 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 (for foods other than food supplements) or table 2 (for food supplements) 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

the declared values for the vitamins and minerals added to foods exceed 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.

 

The tolerance range described in 5.3 includes 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.

 

Example 6:

  • 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 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
  • 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 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 which specifies 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 7:

  • 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
  • Nutrition declaration of the product: fibre: 12 g/100 g
  • According to the rounding rules of section 6 this equals to 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 value 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

  1. g) plus the upper tolerance for fibre from table 3 which is + 40% ; (40 % of 4 = 4.96); 12.4 + 4.96 =

17.36 g/100 g and according to the rounding guidelines of section 6 the upper bound tolerance will be 17 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.

 

  1. 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 12.4 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 12.4g and 11.5
  • In this case the tolerance identified in section 3 would be ±20%, this gives a tolerance on the upper side calculated from 12.4g plus 20% making a total of 14.88g, rounded to
  • If the analysed amount is found to be 15 g, this would be regarded as being within the tolerance, 16 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 “0 g” or “<0.1 g” may be declared
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 0.01 g
no detectable amounts is present or concentration is ≤ 0.005 g per 100 g or ml “0 g” or “<0.005 g”

may be declared

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

 

*Not applicable to sub-categories

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