EFSA advises on the safety of paraben usage in food

Comunicato stampa
29 settembre 2004

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) published today an opinion on the safety of using parabens (additives E 214-219) in foods. The Panel concluded that a group ADI (Acceptable Daily Intake) of 0-10 mg/kg body weight per day could now be established for methyl and ethyl parabens and their sodium salts. However, the panel considered that propyl paraben could not be included in this group ADI due to recent research demonstrating its effects on certain reproductive parameters in rats. While the presence of propyl paraben in the diet is limited and unlikely to represent a risk to consumers, the panel was unable to recommend a specific ADI for propyl paraben based on current evidence. It is now up to the European Commission to decide on any measures to be taken with regards to parabens following the advice of the AFC Panel.

Parabens are antimicrobial preservatives allowed for use in foods, drugs, cosmetics and toiletries. The former EC Scientific Committee for Food (SCF) evaluated the parabens in 1994 and allocated a temporary group ADI (Acceptable Daily Intake) of 0-10 mg/kg bw (milligrams/kilogram body weight), for the sum of methyl, ethyl and propyl p-hydroxybenzoic acid esters and their sodium salts. Following a request from the European Commission (EC), EFSA’s AFC Panel reevaluated the toxicology of these substances and the safety of their usage in foods taking into account findings from recent studies. The panel concluded that a group ADI of 0-10 mg/kg bw could now be established for methyl and ethyl parabens and their sodium salts. However, the panel considered that propyl paraben should not be included in this group ADI because this specific paraben, unlike the methyl and ethyl forms, had effects on sperm production at a relatively low dose in male juvenile rats. The Panel was unable to recommend an ADI for propyl paraben because of the lack of a clear NOAEL (No Observed Adverse Effect Level) for this effect.

Commenting on the conclusions of the opinion on parabens, Dr. Sue Barlow, Chair of EFSA’s AFC Panel explained: “The implications of this opinion for risk management, and in particular the ongoing revision of European legislation on food additives, is of course a matter which will be dealt with by the European Commission. We would agree that there is very unlikely to be any immediate or long term danger to health from the presence of propyl paraben in the diet, particularly given – as far as we are aware-- its very limited use by the food industry in the European Union. The new data examined by the panel indicates that the ADI, which applies to one or any mixture of parabens was not appropriate for propyl paraben. It was not possible for the panel to recommend a specific ADI for this substance based on the current evidence. This issue could be reconsidered if further evidence becomes available.”

Background note to the AFC Opinion on parabens

In carrying out its risk assessment concerning the usage of parabens in foods, EFSA’s AFC Panel evaluated newly available studies on the developmental toxicity of methyl paraben in rats, mice, hamsters and rabbits. No evidence of developmental toxicity was observed even at the highest doses tested and the panel concluded that no further data were required to assess developmental toxicity.

The panel also reevaluated the proliferative effects of parabens on rodent forestomach cells. The experts concluded that such effects will only occur above a certain threshold level and that human exposure resulting from the use of parabens as preservatives will be much below such doses.

In addition, the panel reviewed findings from new studies on the oestrogenic effects of parabens and their effects on reproductive parameters in juvenile male rats. Methyl and ethyl paraben showed no effects on sex hormones and the male reproductive organs in juvenile rats at dose levels up to 1000 mg/kg body weight per day which could therefore be considered a NOAEL (No Observed Adverse Effect Level). However, dietary administration of propyl paraben affected several parameters including the reduction of daily sperm production at the lowest dose level tested of 10 mg/kg body weight per day.

Following review of the findings from long term toxicity studies and studies on sex hormones and the male reproductive organs in juvenile rats, the panel concluded that a group ADI of 0 – 10 mg/kg bw could be set for methyl and ethyl parabens and their sodium salts. However, the panel considered that propyl paraben should not be included in the group ADI and was unable to recommend a specific ADI for this additive due to the lack of a clear NOAEL.

Methyl-, ethyl-, and propyl parabens are permitted in the European Union as food additives in four categories of processed foods by Directive 95/2/EC. They are authorised for use quantum satis (ie according to good manufacturing practice based on the level required to achieve the desired technological effect) for the surface treatment of dried meat products; with a Maximum Permitted Level of 1g/kg in jelly coatings of meat products such as paté; in confectionery, excluding chocolate, at levels of 0.3g/kg; and in liquid dietary food supplements (2 g/kg).  

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