The Use of
Fatty Acids
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- Introduction
- A.P.A.G.
- Responsible Care
- Raw materials for the production of fatty acids
- Typical Ingredients supplied for compounding feedingstuffs
- Background to the proposed Amendment to existing legislation
- Nickel in animal feed supplements
- Environmental consideration
- Summary and Conclusions
- Literature references
1. Introduction
This document is presented by APAG to both the Directorate-General for Agriculture (DG VI.B.II.1 - Legislation relating to crop products and animal nutrition) and the Directorate-General for Industry (DG III. Directorate C - Industrial Affairs I: Basic Industries) of the European Commission for consideration and distribution to all interested parties and relevant Government Authorities.
It seeks to clarify in regard to the proposal for amendments to legislation establishing a list of ingredients whose use is prohibited in compound feedingstuffs (Directive 91/516/EEC), the safe use of fatty acids and its co-products in animal nutrition. This safe use is achieved and will continue to be achieved by proper quality control measures as applied in the laboratories of APAG members. [ back to the top ]
2. A.P.A.G.
The European Oleochemicals & Allied Products group (Groupement Européen des Produits Oléochimiques & Associés) is a non profit-making Association which represents European producers and suppliers of fatty acids, glycerine, alcohols, nitriles and metallic soaps. APAG is affiliated to CEFIC (European Chemical Industry Council). CEFIC too is a non-profit making Association. [ back to the top ]
3. Responsible Care
Both in its own right and as an affiliate of CEFIC, APAG is fully committed to the principles of Responsible Care and Good Manufacturing Practices. This commitment to maintain and improve performance in health, safety and the environment is taken fully into consideration in the preparation of this document alongwith the recommendations and undertakings given. [ back to the top ]
4. Raw materials for the production of fatty acids
Fatty acids are derived from renewable oils and fats of vegetable and animal origin. They are non-toxic and readily biodegradable. [ back to the top ]
5. Typical Ingredients supplied for compounding feedingstuffs
5.1 Hydrogenated triglycerides (hardened tallow)
This product is a neutral fat with the melting point, typically 60 °C, being its most characteristic analytical parameter. Nickel content approximately 1-2 ppm.
5.2 Dairy fat prills
Commercial tallow derived stearine, a mixture of palmitic (C16) and stearic (C18) acid with a melting point of about 50°C. A small amount of nickel (1 to 10 ppm) is possible dependent on the content in the original raw material being processed.
5.3 Palmstearin
Derived from palm oil products (mainly C16) with a melting point ranging between 40-50°C. Nickel as 5.2 above.
5.4 Fatty acid co-product
Results from the distillation of fatty acids of both animal and vegetable origin. Key analytical parameters are, acid value, saponification value and degree of unsaturation. The nickel content can vary up to a maximum of 200 ppm (0.02%) depending on the processes used. [ back to the top ]
6. Background to the proposed Amendment to existing legislation
The European fatty acid industry has for many years without question or known complaint supplied a number of products to manufacturers of animal feedingstuffs. These products are used as ingredients only in feed compounds normally as part of the fat component in various amounts ranging as the total fat content from 2.5%-4.0% in cattle feeds, with up to 10% in poultry feed. None of our products are fed directly to animals.
It has been reported that the Danes have been experiencing problems relating to allegedly high amounts of nickel in hydrogenated palm acid oil. Figures of 600 ppm (0.06%) and higher have been quoted. These are for materials which it is believed have been imported from third countries, as European producers would not normally offer products containing nickel at this level. A European sourced product as illustrated in 5.4 above should never exceed an absolute maximum 200 ppm (0.02%) nickel which, when incorporated as the only fat component of the animal feedingstuff at the additions quoted, would amount at its maximum to only 5 to 20 ppm (0.0005%-0.002%) in the final feed. Since the other ingredients would normally be free of nickel, this is far below the lowest observed effect level (LOEL) (i) of nickel in animal feeding studies, as will be documented later. [ back to the top ]
7. Nickel in animal feed supplements
It has been alleged that nickel containing materials at any level are detrimental to animal and human health. Such statements which although profoundly expressed do not, to the best of our knowledge, bear evidence to support such claims. It is in this regard that APAG Members who supply a considerable tonnage of product to the animal feed manufacturing industry challenge the basis of these allegations and present argument and refutal evidence accordingly.
7.1 Oral toxicity of nickel.
The toxicity of nickel and its salts through oral intake is low. Elemental nickel (in which form nickel is mainly present in fatty acids for animal feed supplements) is not acute toxic (i). Many studies on animals with Nickel in the feed have been done with no apparent effect at several hundred ppm. The lowest effect level observed in feeding studies with calves are around 400 ppm (0.04%) nickel with only one isolated instance of 100 ppm (0.01%)nickel in the complete feed (i).
Nickel and their salts exert their action mainly by gastrointestinal irritation and not by inherent toxicity.
7.2 Absorption in tissue by oral administration.
Elemental nickel and poorly soluble nickel salts are very poorly absorbed from ordinary diets and are eliminated in the faeces. With human volunteers who ingested 300 mg nickel per day faecal elimination was 90% (ii).
All studies suggest that there appears to be a mechanism in mammals that limits intestinal absorbtion of nickel. Large doses of nickel are necessary to disrupt homeostatic mechanisms controlling nickel metabolism, thus increasing the tissue levels of nickel. Soluble nickel salts are more readily absorbed than insoluble forms of nickel.
7.3 Toxicology study by ECETOC.
The European Chemical Industry Ecology and Toxicology Centre (ECETOC) has prepared for the European Catalyst Manufacturers Association (ECMA) a profound study on the toxicology and epidemiology of nickel and nickel compounds (iii). ECETOC reviewed the data available with particular reference to metabolism, animal carcinogenicity, mutagenicity and epidemiology. One of the important conclusions is that the relevant data available do not justify the classification of metallic nickel and nickel oxide as proven toxic or carcinogenic substances. Most concerns related to nickel and its compounds is the respiratory intake of certain forms of nickel.
7.4 Nickel policy in the animal feed industry in the USA.
It is reported that the American Feed Control Official guidelines classifies nickel as moderately toxic and suggests a maximum tolerance level in the complete feed of 50 ppm (0.05%) nickel as a self imposed limit (= up to 500 ppm nickel in a compound feed ingredient). [ back to the top ]
8. Environmental considerations
It has also been alleged, again without supporting evidence, that the real danger of nickel in animal feed and likely to effect the human element, arises from animal excretion of urine and/or faeces. This, it is said, could occur from the subsequent human consumption of crops grown on land which has been fertilized by the said excrement.
We have searched for evidence to corroborate this claim and in the absence of literature known to us we can only quote the opinion of a reputable environmental safety laboratory.
"Assuming a daily consumption per cow of 1 kg of animal feed supplement containing 25 ppm nickel with 100 grazing cows per hectare during a whole year, the maximum total annual addition of nickel to permanent pasture is only negligible at 0.9 kg/hectare/year". This is well below the allowable limit of nickel in sludge at 3.0 kg/hectare/year when applied to land as a fertilizer.
Once again, the concerns being expressed in this regard would appear to be rather excessive. [ back to the top ]
9. Summary and Conclusions
APAG entirely agrees that animals should not be exposed to heavy metal levels that could harm their health. The current proposal to set the nickel limit at zero for animal feed ingredients is however excessive and is by no means justified by the relevant information available on the health effects of nickel by oral intake.
In view of the overwhelming evidence that toxicological effects of nickel are due to overexposure (see 7.2) APAG, the Oleochemical Industry, undertakes in accordance with Good Manufacturing Practices to limit the presence of nickel in fatty acids and its co-products as supplied to animal feed manufacturers to an absolute maximum of 200 ppm (0.02%). We believe that these measures should be integrated within an overall feedingstuffs policy so as to include imports from third countries, and other ingredients, over which APAG has no control and can give no guarantee.
It is then the responsibility of the animal feed industry to take all necessary measures to control the quality of the ultimate feed. To assist them in this process, APAG members are prepared to supply with each delivery a Certificate of Analysis or a Certificate of Conformity to include the content of nickel present.
The Oleochemical Industry is confident in accordance with all the published evidence available, that the controls undertaken as above to limit the nickel content in its products will eliminate the need for the proposed legislation in regard to the ingredients supplied for animal feeds. [ back to the top ]
10. Literature references
(i) Advances in Modern Toxicology, published by John Wiley & Sons, Vol 2 Toxicology of trace elements - Chapter V, Nickel Toxicity.
(ii) Environmental Health Criteria 108, Nickel. Report published by the World Health Organization, Geneva (1991).
(iii) ECETOC Technical Report 33 - Nickel and Nickel Compounds: Review of Toxicology and Epidemiology with special reference to Carcinogenesis.
T.A. WINNEY
Secretary General APAG
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