The EFSA Journal (2004) 96, 1-5 Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a request from the Commission on safety of formaldehyde for poultry as feed additive in accordance with Council Directive 70/524/EEC (Question N o EFSA-Q-2004-032) Adopted on 14 September 2004 SUMMARY Formaldehyde is used in animal feed as a preservative or as a decontamination treatment. This product is authorised at Community level for skimmed milk for piglets up to the age of six months and for all species or categories of animals for silage only and without time limit. The Notifier is now seeking authorisation for an extension of use for poultry of all categories. The Commission requests the European Food Safety Authority to issue an opinion on the safety of formaldehyde for poultry. Previously the efficacy and safety of this product have been addressed by the Scientific Committee on Animal Nutrition. This opinion reviews the additional data presented by the Notifier. Only one new tolerance study carried out on chickens for fattening has been submitted, no other studies on other poultry categories were presented. In this four-week study with 192 broilers (six replicates per treatment, 8 broilers per replicate) a control mash feed was compared to a mash feed treated with 330 mg, 660 mg and 990 mg kg -1 feed of formaldehyde. Formaldehyde had no significant effect on feed intake and body weight at all ages. Feed conversion was not significantly affected by 660 mg kg -1 feed, the dose considered as the maximum recommended dose. However at 990 mg kg -1, feed conversion was significantly worse than that of control birds and those given 330 mg. The safety margin could not be defined but it is likely to be in the region of 1.5 times the recommended dose. The FEEDAP Panel concludes that formaldehyde appears safe for chickens for fattening at the recommended dose; however there was little margin for error before adverse effects were apparent. No conclusion can be reached concerning safety for other categories of poultry. KEY WORDS Formaldehyde, poultry, chickens for fattening, safety, tolerance
Opinion on Formaldehyde for poultry p. 2/5 BACKGROUND Council Directive 70/524/EEC 1 establishes rules governing the Community authorisation of additives for animal nutrition and in particular defines the conditions that a substance/product should meet to be granted authorisation. Formaldehyde is a natural component in living organisms and is used in animal feed with the purpose to preserve them. It is authorised at Community level by Commission Directive 83/466/EEC 2 of 28 July 1983 for skimmed milk for piglets up to the age of six months and by Commission Directive 86/403/EEC of 28 July 1986 3 for all species or categories of animals for silage only and without time limit. The company asked to extend the use for poultry and pigs. Table 1. Condition of use of formaldehyde EC No Additive Chemical formula and description Species or category of animal Maximum age Minimum content Maximum content mg kg -1 of complete feed Other provisions E240 Formaldehyde CH2O Poultry - 660 As an aqueous spray using air atomization apparatus in a purpose designed application system equipped with suitable facilities for containing any possible emission and venting those emission to a safe place. TERMS OF REFERENCE The Commission requests the European Food Safety Authority to issue an opinion on the safety for target species (poultry) of the additive formaldehyde, when this product is used under the above mentioned conditions. 1 O.J. n L 270 of 14.12.1970, p.1 2 O.J. n L 255 of 15.09.1983, p.28 3 O.J. n L 233 of 20.08.1986, p.16
Opinion on Formaldehyde for poultry p. 3/5 ASSESSMENT 1. Introduction Formaldehyde (HCHO) is a colourless gas, soluble in water. Aqueous solutions with a concentration of formaldehyde between 30 and 50 % are commonly referred as formol or formalin. Formaldehyde is widely used in industry. It is also used in agriculture as a single decontamination treatment, as a preservative (silage additives) and to protect proteins in feed. The Scientific Committee of Animal Nutrition issued an opinion in June 1999 on the use of formaldehyde as a preserving agent for animal feedingstuff. This opinion updated a previous report of October 1995. The Scientific Committee identified a number of shortcomings in the dossier presented and could not therefore conclude on the safety or the efficacy of the product when used in animal feedingstuffs. In August 2000, the company submitted a supplementary dossier in reply to the SCAN opinion. The SCAN updated its previous opinion in October 2002 on the safety for target species (piglets and poultry) and users and consumer safety and environmental safety 4. SCAN pointed out that although chickens were able to tolerate feed treated with formaldehyde at the recommended application rate there was little margin for error before adverse effects were apparent. The applicant submitted a new dossier in July 2003, including a new tolerance study with chickens for fattening was presented. 2. Tolerance test on chickens for fattening A study was carried out with 192 broilers offered untreated mash feed or mash feed treated with formaldehyde (330 mg, 660 mg and 990 mg kg -1 feed) for a period of 28 days. There were six replicates per treatment group and a replicate comprised eight broilers. The broilers were housed in a battery. The mash feed was treated with formalin (37 % formaldehyde content). The formaldehyde content of the feed was confirmed by laboratory analysis. The experimental rations were fed from day-old until 28 days of age. Body weight and feed intake were recorded at 0, 7, 14, 21 and 28 days of age. Each week, one bird per replicate was killed and a detailed post-mortem examination was carried out on the tissues. Tissues examined were gizzard, duodenal loop with pancreas, small intestine at Merkel s diverticulum, ileum, both ceca, kidney, liver and sections of any oral/oesophageal lesions/erosions and ulcers if these were seen during examination. Organ weights were not measured during examination. No haematology and clinical chemistry were undertaken. Supplementing the diet with 330 mg, 660 mg or 990 mg formaldehyde had no effect on feed intake and body weight at all ages (0, 7, 14, 21 and 28 days of age). The feed conversion ratio was significantly higher in the 990 mg formaldehyde group compared with the control group over the whole period 0-28 days (Table 2). 4 http://europa.eu.int/comm/food/fs/sc/scan/out95_en.pdf
Opinion on Formaldehyde for poultry p. 4/5 Table 2. Effect of formaldehyde on body weight, feed intake and feed conversion (mean + standard error) Group Dose Formaldehyde mg kg -1 Body weight 28 days g/broiler Feed intake 0-28 days g/broiler Feed conversion 0-28 days kg kg -1 1 0 1432 ± 17 1898 ± 35 1.49 ± 0.01 a 2 330 1451 ± 14 1941 ± 26 1.48 ± 0.00 a 3 660 1447 ± 19 1949 ± 20 1.51 ± 0.01 ab 4 990 1420 ± 19 1968 ± 22 1.53 ± 0.01 b a, b - Values in columns with different superscripts differ significantly (p<0.05) During the post-mortem examination, no oral or esophageal lesions were observed. There was no evidence of toxicological effects in any of the tissues examined. The dose levels used in this tolerance study (using a maximum of 1.5 times the maximum recommended dose) were selected in the light of the results of the three previous tolerance studies reviewed by SCAN. In these studies, doses up to ten times the recommended dose were included. In these earlier tolerance studies on growing chickens a dose dependent decrease in feed intake and body weight gain was noted when formaldehyde was added at levels of 1980 mg, 3300 mg and 6600 mg. In trial 2 an indication of reduced feed intake and body weight gain during the first trial weeks could be seen even at the recommended dose level of 660 mg kg -1 feed. In tests 2 and 3 there was a general decrease in the absolute weights of the organs that were weighed. Relative weights of most of the organs increased due to the reduced body weight. The exception to this was a decrease in relative weights of spleen and bursa at 6600 mg kg -1 only. This observation may reflect toxicity. Although chickens for fattening were able to tolerate feed treated with formaldehyde at the recommended application rate there was little margin for error before adverse effects were apparent. No tolerance tests on laying hens or other poultry categories were presented. CONCLUSIONS One new tolerance test carried out with broilers over a 4 week period with half the recommended dose (330 mg), the recommended dose (660 mg) and a 1.5 x overdose (990 mg) of formaldehyde produced no evidence of any adverse effect on body weight and feed consumption, gross pathology and histopathology. The feed conversion ratio was significantly higher in the 990 mg formaldehyde group compared with the control group. By considering the one new test and the three previous tests the FEEDAP Panel concludes that formaldehyde is safe for chickens for fattening at the recommended dose. The margin of safety could not be accurately determined, it is however likely to be in the region of 1.5 times the recommended dose. The Panel considers it impossible to extrapolate the results obtained to other poultry species. DOCUMENTATION PROVIDED TO EFSA
Opinion on Formaldehyde for poultry p. 5/5 1. A response to the SCAN Opinion on formaldehyde, dated July 2003 and submitted by Anitox Ltd 2. Addendum to the Anitox Response (July 2003) to the SCAN opinion on formaldehyde, dated November 2003 3. Anitox submission to EFSA, dated May 2004, containing the documents under 1) and 2) and documents dated November 2001 and May 2002 as responses and clarification to questions raised by SCAN. SCIENTIFIC PANEL MEMBERS Arturo Anadón, Margarita Arboix Arzo, Georges Bories, Paul Brantom, Joaquim Brufau de Barbera, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Dierick, Gerhard Flachowsky, Anders Franklin, Jürgen Gropp, Anne-Katrine Haldorsen, Ingrid Halle, Alberto Mantovani, Kimmo Peltonen, Guido Rychen, Pascal Sanders, Amadeu Soares, Pieter Wester and Wilhelm Windisch ACKNOWLEDGEMENT The Scientific Panel on Additives and Products or Substances used in Animal Feed wishes to thank professor Atte von Wright for the contribution to the draft opinion.