Polyols and food additives in general can only be used provided that they do not present a hazard to health, there is reasonable technological need, their use does not mislead the consumer, and their use benefits the consumer.
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)
As all food additives, the safety of polyols is being re-evaluated by EFSA according to a programme established in Commission Regulation (EU) 257/2010. For this purpose EFSA has launched in June 2017 a call for technical and toxicological data on sweeteners authorised as food additive in the EU (deadline: 30/06/18) and in January 2018 a call for usage level and/or concentration data in food and beverages intended for human consumption.
On 27 June 2018 EPA has provided to EFSA the information requested in the call for technical and toxicological data for the following polyols:
- E 420i – Sorbitol
- E 420ii – Sorbitol syrup
- E 421i – Mannitol
- E 953 – Isomalt
- E 965i – Maltitol
- E 965ii – Maltitol syrup
- E 966 – Lactitol
- E 967 – Xylitol
- E 968 – Erythritol.
EPA is committed to liaise with the associations representing the main users of polyols for the preparation of their submission on usage level data as required.
The re-evaluation of polyols by EFSA shall be completed by end 2020.
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”. At its 86th meeting (June 2018), the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded that based on the similarity of the chemical constituents of sorbitol syrup to the previoulsy evaluated sorbitol, maltitol syrup and polyglycitol syrup, there is no need for a separate evaluation of sorbitol syrup and estabished an ADI “not specified” for sorbitol syrup. 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, according to the authorisation procedure laid down in Regulation (EC) 1331/2008. The use of polyols in food applications is regulated Regulation (EC) 1333/2008 on food additives, which entered into force on 20 January 2009: its Annex II that provides the Union list of approved food additives and their conditions of use is established by Regulation (EU) 1129/2011 that applies since 1 June 2013. As soon as a new polyol has been positively evaluated by EFSA, the European Commission will propose an amendment to the existing Regulations with the aim to authorise the new polyol together with the polyols already existing on the market (currently isomalt, lactitol, maltitol, mannitol, sorbitol, xylitol, erythritol and polyglycitol syrup). The polyols may only be used in the food applications as laid down in Regulation 1129/2011 at “quantum satis” (with the exception of polyglycitol syrup, the use of which is submitted to numerical limits). “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. 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 (exception: erythritol is permitted in flavoured drinks energy-reduced or with no added sugars, as flavour enhancer only, with a maximum limit of 16000 mg/l). They may also be used as food additives, enzymes and flavour carriers. Regulation (EU)1129/2011 regroups the authorisations for food additives that were formerly spread over four Directives. Hence, polyols that were permitted for use in food under the former Directive 94/35/EC and Directive 95/2/EC have been transferred in the Union list, which 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:
- for sweetening purposes
- 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.
Salads and savoury based sandwich spreads
Polyols are permitted at quantum satis for purposes other than sweetening purposes.
Extra jam and extra jelly as defined by Directive 2001/113/EEC
Polyols are permitted at quantum satis for sweetening purposes in energy-reduced or with no added sugar jams, jellies, marmalades.
Only energy-reduced jams, jellies, marmalades or with no added sugar
Polyols are permitted at quantum satis for sweetening and non sweetening purposes (e.g. humectant) in chewing gums. However, if they are used for sweetening purposes, it can be only in chewing gums with no added sugars.
Only with no added sugars
Fruit nectars as defined by Council Directive 2001/112/EC and vegetable nectars and similar products
All food additives of Group I can be used in vegetable nectars, except polyols
Only vegetable nectars – E 420, E 421, E 953, E 965, E 966, E 967 and E 968 may not be used
Spirit drinks as defined in Regulation(EC) 110/2008
All food additives of Group I can be used in spirit drinks, except polyols.
However polyols can be used in liqueurs at quantum satis for purpose other than sweetening.
None of the additives of Group I can be used in whisky or whiskey.
Except whisky or whiskey;
E 420, E 421, E 953, E 965, E 966, E 967 and E 968 may not be used except in liqueurs
Polyols are permitted at quantum satis for purposes other than sweetening ( the other Group I additives are not permitted in this category).
Only frozen and deep-frozen unprocessed fish for purposes other than sweetening
Polyols are permitted at quantum satis for sweetening and non-sweetening purposes.
Food categories are described in a non-legally binding Guidance document published by the European Commission in December 2013, with the aim to help Member State control authorities and food industry to assure correct implementation of the food additives legislation. “Regulation (EU) 1130/2011, which entered 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 former 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). The authorisations for polyols in food flavourings and as carriers in food additives are strictly the same in this Regulation as in the former 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.”
Polyols are labelled on the food packages. Detailed rules on labelling of additives in foodstuffs and on additives sold as such to food producers and consumers are laid down in Regulation (EC) 1333/2008 on food additives and in Regulation (EU) 1169/2011 on the provision of food information to consumers that applies from 13 December 2014. The labelling provisions for polyols are unchanged compared to former legislation. Polyols are designated by their functional class (for example sweetener, bulking agent, humectant…) with either their specific name or E-number. In addition, a foodstuff containing polyols is labelled “with sweetener(s)” in addition to the listing of the given polyols in the ingredient list; 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 II of in Regulation (EU) 1169/2011 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:
- 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 in Annex XIV of Regulation (EU) 1169/2011. The only exception is erythritol, which is given the energy value of 0 kcal/g.
Nutrition and 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). Based on the EFSA opinion on the substantiation of health claims related to the sugar replacers xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose and polydextrose and maintenance of tooth mineralisation by decreasing tooth demineralisation and reduction of post-prandial glycaemic responses pursuant to Article 13.(1) of Regulation (EC) 1924/2006, the European Commission has included the following provisions in the Regulation (EU) 234/2012 establishing a Community list of permitted claims in foods, other than those referring to the reduction of disease risk and to children’s development and health:
Nutrient, substance, food or food category
Conditions of use of the claim
Conditions and/or restrictions of use of the food and/or additional statement or warning
EFSA Journal number
|Sugar replacers, i.e. intense sweeteners; xylitol,sorbitol, mannitol, maltitol, lactitol,isomalt, erythritol, sucralose and polydextrose; D-tagatose and isomaltulose||Consumption of foods/drinks containing “name of sugar replacer” instead of sugar (**) contributes to the maintenance of tooth mineralisation.|
**In the case of D-tagatose and isomaltulose this should read “other sugars”
|In order to bear the claim, sugars should be replaced in foods and drinks (which reduce plaque pH below 5.7) by sugar replacers, i.e. intense sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, in amounts such that consumption of such foods or drinks does not lower plaque pH below 5.7 during and up to 30 minutes after consumption||/||2011; 9(4):2076|
2011; 9(6): 2229
|Sugar replacers, i.e. intense sweeteners; xylitol,sorbitol, mannitol, maltitol, lactitol,isomalt, erythritol, sucralose and polydextrose; D-tagatose and isomaltulose||Consumption of foods/drinks containing <name of sugar replacer> instead of sugar (*) induces a lower blood glucose rise after their consumption compared to sugar- containing foods/drinks|
*In the case of D-tagatose and isomaltulose this should read “other sugars”
|In order to bear the claim, sugars should be replaced in foods or drinks by sugar replacers, i.e. intense sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose or polydextrose, or a combination of them, so that foods or drinks contain reduced amounts of sugars by at least the amount referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.|
In the case of D-tagatose and isomaltulose, they should replace equivalent amounts of other sugars in the same proportion as that referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006.
|/||2011; 9(4):2076 2011; 9(6): 2229|
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, notably sugar-free chewing gums. The permitted health claims based on these opinions are regulated:
- either by Regulation (EU) 234/2012 for health claims other than those referring to the reduction of disease risk and to children’s development and health
- or by separate Regulations for health claims made on foods and referring to the reduction of disease risk or to children’s development and health, e.g. Regulation (EU) 665/2011 which reflects the positive EFSA opinion on sugar-free chewing gum and reduction of tooth demineralisation.
All claims are regrouped in the EU Register of nutrition and health claims made on foods.
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. 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 a similar product (Regulation (EU) 1047/2012).
- “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”
The EPA commissioned a legal opinion from a specialist Food Law Firm in Brussels which concludes that there are strong legal grounds to back up the continued lawful use of the nutrition claim “with no added sugars” in foods in which sugars have been replaced with polyols. You will find here the EPA statement. Please find here the Summary legal opinion.
NOVEL FOOD INGREDIENT
Commission implementing Regulation (EU) 2017/450 amended by Commission implementing Regulation (EU) 2018/1293 has authorised lactitol to be placed on the EU market as a novel food ingredient to be used in food supplements in capsules, tablet or powder form intended for the adult population with a maximum dose of 20 g lactitol per day. In such case the labelling of the food supplements containing it shall be “lactitol” only (no reference to a class of additive or to E number). A related health claim “Lactitol contributes to normal bowel function by increasing stool frequency” was granted for this application by Commission Implementing Regulation (EU) 2017/676.