EFSA advises on the safety of paraben usage in food

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 An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. (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 The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem. in male juvenile rats. The Panel was unable to recommend an ADI for propyl paraben because of the lack of a clear NOAEL The no observed adverse effect level (NOAEL) is the greatest concentration or amount of a substance at which no detectable adverse effects occur in an exposed population. (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 The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment., 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 An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs., 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.”

• Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to para hydroxybenzoates (E 214-219)

Background note to the AFC Opinion on parabens

In carrying out its risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. concerning the usage of parabens in foods, EFSA’s AFC Panel evaluated newly available studies on the developmental toxicity Any adverse effect on the development of the unborn, babies, infants or children when exposed to a toxic substance. of methyl paraben in rats, mice, hamsters and rabbits. No evidence of developmental toxicity The potential of a substance to cause harm to a living organism. 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 A dose or exposure below which adverse effects are not detected. level and that human exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. 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 An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health. It is usually expressed as milligrams of the substance per kilogram of body weight per day and applies to chemical substances such as food additives, pesticide residues and veterinary drugs. 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 Any practice regarding the conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain. 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).