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Euro legislation on contaminants - an emerging crisis for industry

Nutraceuticals International
Peter Berry Ottaway
February 2003
SECTION: Vol 8, No 2

1 of 22 During the past year, the major cause of supplement product recalls and withdrawals from the European market was non-compliance with general food legislation, and not related to issues specific to supplements and herbal products.

As predicted (NI vol 7, no 4), the mass of European food law relating to contaminants has begun to bite. The European Union has adopted a number of principles in relation to food safety. These are laid down in the Regulation on General Food Law, published in February 2002, and include the requirement for a high level of protection of human health and life with the control of food "from farm to table."

PCBs and PAHs next on the action list? One aspect of this legislation is the control of a wide range of chemical contaminants that can be found in the food chain and, to this end, the European Regulation on Contaminants in Food (EC No466/2002) came into effect in April 2002. This has already been amended a number of times and now includes heavy metals (lead, cadmium, and mercury), dioxins, 3-monochloropropane-1,2-diol and certain mycotoxins. It is almost certain that polychlorinated biphenyls and polycyclic aromatic hydrocarbons will be added to the list of controlled contaminants in the near future.

The controls, in general, are applied to food commodities and not to the final products. For example, there is a 0.1 mg/kg (parts per million) limit for lead in all fats and oils. There are very low limits for cadmium in soybeans, bran, wheatgerm and rice, and there is a distinct possibility that the Commission will increase the cadmium requirements to include some oil seeds (sunflower, ground nuts and linseed) in the near future. Most fishery products, including fish oils, have a 1.0mg/kg (ppm) limit for mercury content.

Since July 1, 2002, there have been controls on the level of dioxins and furans in both fish and vegetable oils. Fish oils have an upper limit of 2pg per gram of oil (according to the World Health Organization's WHO-PCDD/F TEQ criteria; see later). Since this limit was introduced, both the UK and Irish authorities have carried out surveys of dioxin levels in fish oil supplements. In both cases, it was found that a high percentage of products did not meet the 2pg limit, with values four to five times the legal maximum being reported (NI vol 7, nos 4 and 7).

Within the next two years, the Commission intends to add maximum levels for the dioxin-like PCBs to the legislation. Due to their position in the food chain, and biomagnification effects, fish accumulate much higher levels of PCBs in their oil and liver than land animals. High dioxin-like PCB levels are found in fish oils, and particularly fish liver oils, which have not been subjected to expensive processing to remove them.

Although upper limits for the dioxin-like PCBs have not yet been set by the Commission, the indications are that they will not be very generous. In order to stay in the European market, fish oil processors will have to ensure that they have operations capable of reducing PCBs in the oil to below the legal limits. In some cases, this may require a significant capital investment. The official surveys carried out on fish oils in 2002 showed dioxin-like PCB levels up to 41pg/g oil and it is likely that any legal limit will be in single figures.

In addition to the dioxin-like PCBs, the Commission is also considering whether non-dioxin-like PCBs should be controlled by legislation. Some European countries, such as Germany, Denmark and the Netherlands, already have internal legislation limiting levels of this group of contaminants in fish oils, and they are pressing for control on a pan-European basis.

Non-dioxin PCBs pose a complex problem

Introduction of the non-dioxin-like PCBs into the law will introduce a complex situation. The limits for dioxins, furans and dioxin-like PCBs are all based on a toxic equivalent value, which is derived by multiplying the measured weight of the individual congeners by a WHO toxic equivalency factor to give a TEQ. The TEQs for all the relevant congeners are added together to give a total value, and the law is based on this value. The non-dioxin-like PCBs have not been assigned toxic equivalency factors by the WHO, so values reported are the measured weights as individual congeners. Potential legislation will require two sets of values, one based on TEQs and one on empirical measurement.

In addition to fish oils, the law on dioxins and furans applies to all vegetable oils with the upper limit set at 0.75pg WHO-TEQ/g oil.

Copyright 2003 Marketletter Publications Ltd.


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