EFSA panel says PEGs are safe for supplements
glycol as film coating for food supplements at six grades would not
present a risk at proposed levels, which will be used to inform the
EC's decision on whether to modify the relevant directive.
Polyethylene glycols (PEGs) are described by EFSA as addition polymers of ethylene oxide and water identified by a number approximating to their molecular weight - that is, their grade.
The panel reviewed the available toxicity studies, mutagenicity tests and human clinical trials on PEGs at the request of the European Commission, which received a request from US-based Colorcon to use PEGs as plasticizers for aqueous coatings for food supplements in the EU in six grades: 400, 3000, 3350, 4000, 6000, and 8000.
The EC will now make a decision as to whether to modify Directive 95/2/EC on food additives other than colours and sweeteners to allow for PEG to be used in supplements. If it decides to do so, this would mark an addition to the armoury of stable coating technology available to European supplement-makers.
Since 1998 polyethylene glycol the EC has allowed the use PEG as a carrier for sweeteners at 6000 grade, but no other grade or use is currently permitted in foods. However a coating with PEG-containing films is allowed for pharmaceutical tablets and capsules.
There is no guarantee, however, that the EC will opt to modify the directive on the basis of the EFSA panel's decision.
One of the key factors weighed up by the panel is PEG consumption levels from supplements. In 1979 PEGs 200 and 9500 were assessed by the Joint FAO/WHO Expert Committee on Food Additives as carriers and excipients, and an acceptable daily intake (ADI) of 10mg per kg of body weight was set.
The EFSA panel estimated that the proposed use of PEG in food supplements would lead to a calculated intake estimate up to 120mg/day - that is, for a person of 60kg body weight, 2mg per kg of body weight per day.
PEG intake from pharmaceutical products was estimated to be around the same level, and exposure from their use as carriers for sweeteners was said to be "limited". This, the panel said, would mean that estimated daily intakes would still be way below the FAO/WHO ADI.
In the US, however, PEGs are permitted for a much broader range of uses: 200 to 9500 PEGs are permitted as a direct, multipurpose food additive, and they can be used in many pharmaceutical and dietary supplement products for oral use.
PEGs have an excellent record on stability in air, solutions and during storage. Colorcon has said it knows of no known incompatibilities between PEGs and typical active ingredients in supplements, and that PEG is not expected to react with other components in products or in the gastrointestinal tract.
