POLYOLS / FOOD APPLICATIONS / LEGISLATION

Safety

Like all additives, polyols need to be evaluated for their safety by an independent scientific body (risk assessor) before being considered for authorisation in a given market. At international level, the risk assessor is the Joint WHO/FAO Expert Committee, at European level the European Food Safety Authority (EFSA) - previously the Scientific Committee on Food (SCF). The independence of these scientific bodies is crucial to regulators, consumers and industry alike.

Once an additive has been found safe by an independent scientific body it is given an Acceptable Daily Intake (ADI). The ADI is the amount of a food additive that can be consumed in the diet every day throughout life without health risks. The granting of an ADI and the approval of a substance signifies that a product is safe. Both JECFA and SCF (now EFSA) has given the polyols an ADI “not specified” which is the highest safety rating that can be given to any food additive and which translates into provisions for use of GMP (Good Manufacturing Practice) and “quantum satis” (no maximum level indicated).

Safety evaluations by JECFA and SCF (now EFSA) are available from the relevant websites:

• JECFA monographs and evaluations (key in the name of the polyol)
• SCF report on sweeteners: 16 th Series, 1985; and 21 st Series, 1989
• SCF report on erythritol (2003)

Legislation – provisions for use

After the risk assessor has given its opinion on the safety of a food additive, it is up to the risk manager to propose relevant provisions for use. At international level, the risk manager is the Codex Committee on Food Additives (CCFA) whose role it is to forward draft food additives provisions in the General Standard for Food Additives (GSFA) for adoption by the Codex Alimentarius Commission. With an ADI “not specified”, all the polyols in the GSFA (erythritol, isomalt, lactitol, maltitol, mannitol, sorbitol, and xylitol) have been adopted as additives “permitted for use in food in general, unless otherwise specified, in accordance with GMP”. The adopted provisions in the GSFA serve as a basis for several Member States’ legislation on polyols.

In the EU, the risk manager is the European Commission. The European Commission is responsible for proposing the authorisation of a new food additive on the basis of a positive EFSA opinion. Due to the many technical functions of a polyol (bulk sweetener, bulking agent, flavour enhancer, humectant, stabiliser, sequestrant, or thickener), its use in food applications is regulated by two directives: Directive 94/35/EC of the European Parliament and Council on sweeteners for use in foodstuffs (polyol used as bulk sweetener) and by Directive 95/2/EC of the European Parliament and Council on food additives other than colours and sweeteners (polyol used as miscellaneous additive). As soon as a new polyol has been positively evaluated by EFSA, the European Commission will propose an amendment to the existing Directives with the aim to authorise the new polyol together with the polyols already existing on the market (currently isomalt, lactitol, maltitol, mannitol, sorbitol, xylitol and erythritol).

The polyols may only be used in the food applications as laid down in the Annexes to these Directives at “quantum satis” (see the Annex of the Directive on sweeteners and Annex IV and V of the Directive on miscellaneous additives). “Quantum satis” means that no maximum level is specified. Polyols shall be used in accordance with Good Manufacturing Practice (GMP), at a level not higher than is necessary to achieve the intended purpose and provided that they do not mislead the consumer.

The legislation allows for a wide range of applications. When used for sweetening purposes, a wide range of preparations for desserts and confectionery products are allowed and when used for purposes other than sweetening, polyols may be used in foodstuffs in general, except drinks and other foods such as unprocessed foodstuffs, foods for infants and young children. They may also be used as food additives, enzymes and flavour carriers.

Regulation (EC) 1333/2008 on food additives entered into force on 20 January 2009, along with the Regulation (EC) 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. The new legislation on food additives regroups in a single Regulation the existing authorisations for food additives that are currently spread over four Directives, and the Directive 89/107/EEC on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption. Polyols that are permitted for use in food under Directive 94/35/EC and Directive 95/2/EC have been transferred in a single “Community list of food additives approved for use in foods and conditions of use” that is established by Regulation (EU) 1129/2011, which shall apply from 1 June 2013. Until application of the new Regulation, conditions of use of polyols are still laid down by Directive 94/35/EC and Directive 95/2/EC.

The Community list is included in Annex II of Regulation (EC) 1333/2008; it presents all food additives permitted per food category, according to a new Food Categorisation System.

The authorisations for polyols are strictly the same in this new Regulation as in the Directives, only the presentation is different:

• The general denomination “Group I – additives” covers food additives other than colours, which are generally permitted for use at quantum satis in a wide range of foodstuffs. In practice it covers polyols that are used for purposes other than sweetening purposes.
• The specific denomination “Group IV – polyols” appear where polyols are permitted:
  o for sweetening purposes
  o for purposes other than sweetening in the few applications where the other additives in Group I are not authorised.

Particular restrictions of use, for example in beverages, are specifically mentioned. For certain food categories polyols may appear twice, i.e. as “Group I – additives” for use as e.g. bulking agents and as “Group IV - polyols” for use as sweeteners.

Regulation (EU) 1130/2011, which enters into force on 2 December 2011 and applies from the same date, establishes the Annex III to Regulation (EC) 1333/2008, i.e. the Union list of food additives approved for use in food additives, food enzymes, food flavourings and nutrients. This Annex combines existing legislation (e.g. the list of permitted carriers in food additives) and new legislation (e.g. additives in enzymes, or additives other than carriers in additives). A transition period is set for situations not regulated so far at EU level, regarding ingredients which were placed legally on the market before.

The authorisations for polyols in food flavourings and as carriers in food additives are strictly the same in this new Regulation as in the current legislation. In addition, the list of polyols permitted in enzymes and all nutrients is now defined. On the other way round, the anti-caking agents that may be added to powdered polyols are listed too.

Legislation – purity criteria

All authorised food additives have to fulfil purity criteria which are set out in detail in three Commission Directives. The purity criteria for polyols are covered by Directive 95/31/EC lying down specific criteria of purity concerning sweeteners for the use in foodstuffs.

Legislation – labelling

Polyols are labelled on the food packages. They are designated by their functional class (for example sweetener, bulking agent, humectant…) with either their specific name or E-number. Detailed rules on labelling of additives in foodstuffs and on additives sold as such to food producers and consumers are laid down in two EU Directives: Directive 2000/13/EC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (see specifically article 6,4(a) and article 6(6)) and Regulation (EC) 1333/2008 on food additives.

In addition, the so-called “double labelling Directive” – Commission Directive 2008/5/EC concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Directive 2000/13/EC - requires that a foodstuff containing polyols is labelled “with sweetener(s)” in addition to the listing of the given polyols in the ingredient list; and that a foodstuff containing polyols and sugars is labelled “with sugar(s) and sweetener(s)” in addition to the ingredient listing. Foods containing more than 10% added polyols should also bear the following statement: “excessive consumption may produce laxative effects”.

Annex IIIa of Directive 2000/13/EC establishes a list of food ingredients which must be indicated on the label of foodstuffs as they are likely to cause adverse reactions in susceptible individuals. The Commission Directive 2007/68/EC amends this Annex and lays down that:

• lactitol does not have to be labelled with reference to its milk origin.
• polyols obtained from wheat-based glucose syrups do not have to be labelled with reference to their wheat origin, because wheat based glucose-syrups and products thereof are also excluded from allergen labelling.

Hence, all polyols are excluded from allergen labelling in the EU.

The energy value used in current EU law for labelling purposes gives polyols the energy value of 2.4 kcal/g, as laid down by Directive 90/496/EEC on nutrition labelling The only exception is erythritol, which is given the energy value of 0 kcal/g in Commission Directive 2008/100/EC.

All these Directives are now consolidated in a single Regulation (EU) 1169/2011 on the provision of food information to consumers that shall apply from 13 December 2014. The labelling provisions for polyols are unchanged.

Nutrition and Health Claims

Health claims

The use of nutrition and health claims for foods is regulated in the EU by Regulation EC/1924/2006, which entered into force on 19 January 2007.

Article 13 of the Regulation lays down that the European Commission shall adopt a Community list of permitted health claims other than those referring to the reduction of disease risk and to children's development and health. This Community list shall be adopted following consultation of the European Food Safety Authority (EFSA).

In July 2008, the European Commission sent to the EFSA a list of health claims accompanied by the conditions applying to them and by references to the relevant scientific justification, so that the Authority reviews the proposed claims. Armed with the long-lasting recognition by international authorities of the important role played by polyols in dental health (non cariogenicity and remineralisation of teeth) and in reduction of post-prandial glycaemic responses, EPA has submitted several claims that were assessed by the EFSA, which subsequently delivered its positive opinion on 8th April 2011.

The opinion concludes that:

• Regarding maintenance of tooth mineralisation by decreasing tooth demineralisation: ‘in order to bear the claim, sugars should be replaced in foods or drinks (which reduce plaque pH below 5.7) by xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, so that consumption of such foods or drinks does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion.’
• Regarding reduction of post-prandial glycaemic responses: “in order to bear the claim, sugars should be replaced in foods or drinks by xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, so that foods or drinks contain reduced amounts of sugars as per Annex of Regulation (EC) 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) 1924/2006 of the SCFCAH for comparative nutrition claims made on foods (section 2.3.3.)””.

In addition, a number of other positive assessments were delivered by EFSA for health claims related to foodstuffs in which sugars are replaced with polyols. For example:

Sugar-free chewing gum and reduction of tooth demineralisation
Sugar-free chewing gum and neutralisation of plaque acids
Xylitol chewing-gum reduces the risk of caries in children
Sugar-free chewing gum and plaque acid neutralisation, maintenance of tooth mineralisation, reduction of oral dryness
Sugar-free chewing gum with carbamide and plaque acid neutralisation
Sugar-free chewing gum with fluoride and maintenance of tooth mineralisation
Sugar-free chewing gum sweetened with xylitol and plaque acid neutralisation, maintenance of tooth mineralisation

Based on all EFSA opinions, the European Commission will publish the list of permitted health claims, including those which relate to polyols, likely by end 2011. Some of them are already published, e.g. Regulation (EU) 665/2011 which reflects the positive EFSA opinion on sugar-free chewing gum and reduction of tooth demineralisation.

Nutrition claims
Nutrition claims that are permitted in the EU are defined in the Annex to Regulation (EC) 1924/2006, along with the conditions applying to them. A number of these nutrition claims may be interesting for foodstuffs, in which sugars are replaced by polyols, e.g.:

• “sugars-free”: a claims that a food is sugars-free, and any claim likely to have the same meaning for the consumer, may only be made where the product contains no more than 0.5 g of sugars per 100 g or 100 ml.
• “reduced sugars”: a claim stating that the content in sugars has been reduced, and any claim likely to have the same meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar product.
• “energy-reduced”: a claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be made where the energy is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.
• “ with no added sugars”: a claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: “contains naturally occurring sugars”.
  Of course sweeteners as defined by Regulation (EC) N° 1333/2008 are not considered “food used for its sweetening properties”.

An amendment to this Annex is under preparation:

• It will clarify that the claim “reduced sugars”, and any claim likely to have the same meaning for the consumer, may only be made if the amount of energy of the product bearing the claim is equal to or less than the amount of energy in a similar product.
• It will permit a new claim “now contains x % less of sugars”, or any claim likely to have the same meaning for the consumer, for reformulated products where the reduction in content is at least 15 % for sugars. This claim shall be followed by a statement indicating the content of sugars, prior to reformulation, expressed per 100 g or 100 ml. Such claim may be used for a maximum of one year following the placing on the market of the reformulated product. It may only be made if the amount of energy of the product bearing the claim is equal to or less than the amount of energy in the original product.