Report for 2013 on the results from the monitoring of veterinary medicinal product residues and other substances in live animals and animal products

Question Number
EFSA-Q-2014-00018
Issued
16. Dezember 2014
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Abstract

The present report summarises the monitoring data collected in 2013 on the presence of residues of veterinary medicinal products and certain substances in live animals and animal products in the European Union. A total of 1,005,835 samples were reported to the European Commission by the 28 EU Member States. They consisted of 419,528 targeted samples and 17,561 suspect samples reported under Council Directive 96/23/EC, 3,329 samples collected at import and 565,417 samples collected in the framework of programmes developed under the national legislation. The majority of Member States fulfilled the minimum requirements for sampling frequency laid down in Council Directive 96/23/EC and in Commission Decision 97/74/EC. The percentage of non-compliant targeted samples (0.31 %) was comparable to the previous six years (0.25–0.34 %). A higher frequency of non‑compliant samples was reported in 2013 for stilbenes, antithyroid agents, beta‑agonists, carbamates and pyrethyroids, chemical elements (mainly metals) and mycotoxins, compared to the previous six years. Resorcyclic acid lactones had increased in 2013 compared to the previous three years. The frequency of non‑compliant samples was lower compared to previous years, for anthelmintics and dyes. No non‑compliant samples were reported in 2013 for ‘other substances’. In 2012 and 2013, the frequency of non‑compliant samples for steroids and anticoccidials was comparable, however, lower compared to previous years. Compared to 2012, lower frequencies of non‑compliant samples were noted for sedatives and ‘other pharmacologically active substances’. For the other substance groups, there were no notable variations over the seven years. This analysis should be regarded as having a certain degree of uncertainty, as it is based on partially aggregated data and the sampling plans and the spectrum of substances analysed are not necessarily the same every year. 

Summary

The present report summarises the monitoring data from 2013 on the presence of residues of veterinary medicinal products and certain substances in live animals and animal products in the European Union (EU).

The presence of unauthorised substances, residues of veterinary medicinal products or chemical contaminants in food may pose a risk factor for public health. The EU legislative framework defines maximum limits permitted in food and monitoring programmes for the control of the presence of these substances in the food chain. Regulation (EU) No 37/2010 establishes maximum limits for residues of veterinary medicinal products in food-producing animals and animal products. Maximum residue levels for pesticides in or on food and feed of plant and animal origin are laid down in Regulation (EC) No 396/2005. Commission Regulation (EC) 1881/2006 lays down the maximum limits for the presence of certain contaminants in animal products. Council Directive 96/23/EC lays down measures to monitor certain substances and residues thereof, mainly veterinary medicinal products, in live animals and animal products. Additionally, Commission Decision 97/747/EC lays down levels and frequencies of sampling for certain animal products.

In the framework of Article 31 of Regulation EC 178/2002, the European Commission (EC) asked the European Food Safety Authority (EFSA) to produce an annual compilation of the monitoring results obtained under the provision of Council Directive 96/23/EC. Animal categories and animal products covered in the monitoring are: bovines, pigs, sheep and goats, horses, poultry, rabbit, farmed game, wild game, aquaculture, milk, eggs and honey.

Data were collected in aggregated form in a database managed by the European Commission (EC). Data collected in this form do not allow for an in-depth analysis. The limitations described in the previous EFSA reports (EFSA, 2010a, b, 2011, 2012, 2013, 2014) were still applicable in the present analysis. Therefore, the recommendations made with regard to the collection of data in the EFSA format similar to pesticides and contaminants data remain valid.

 

Altogether, 1,005,835 samples were reported by the 28 EU Member States in the framework of the residue monitoring in 2013. They consisted of 419,528 targeted samples and 17,561 suspect samples reported under Council Directive 96/23/EC, 565,417 samples collected in the framework of other programmes developed under the national legislation and 3,329 samples checked at import. The data analysis presented in this report was focused on the targeted samples reported under Council Directive 96/23/EC. Samples collected through other sampling strategies (suspect, import or ‘other’) do not follow a designed monitoring plan; therefore results on those samples were reported separately from the results on targeted samples.

The majority of the 28 EU Member States fulfilled the minimum requirements for sampling frequency laid down in Council Directive 96/23/EC and in Commission Decision 97/747/EC.

Of the total targeted samples, 1,299 samples (0.31 %) out of the 419,528 target samples were non‑compliant in 2013.

Non‑compliant samples were reported for stilbenes and derivatives (A1) in bovines and pigs (both 0.01 %). For antithyroid agents (A2), there were 0.77 % non-compliant samples, all for thiouracil, most likely due to feeding diets rich in cruciferous plants. In the group of steroids (A3), non‑compliant samples (all for anabolic steroids) were found in bovines (0.04 %), pigs (0.18 %), sheep and goats (0.35 %) and horses (1.73 %).The relatively high percentage of non-compliant results in pigs was most likely the endogenous production. For corticosteroids, non‑compliant results for authorised substances were reported under ‘other pharmacologically active substances’ (B2f) in 2013. In the group of resorcyclic acid lactones (A4), 0.14 % of the samples were non-compliant for zearalanone and derivatives. For beta-agonists (A5), there were 0.05 % non-compliant samples. Prohibited substances (A6) were found in 0.05 % of samples. Substances identified were chloramphenicol (n = 23), nitroimidazoles (n = 9), nitrofurans (n = 6) and chloroform (n = 2).

For antibacterials (B1), 0.21 % of the samples analysed under the Directive 96/23/EC monitoring were non-compliant. The highest frequency of non-compliant samples for antibacterials was found in honey (0.88 %).

In group B2 (other veterinary drugs), the highest proportion of non-compliant samples was found for anticoccidials (B2b) and ‘other pharmacologically active substances’ (B2f) (both 0.16 %). For anticoccidials across the different species, the non‑compliant results were reported as follows; bovines (0.05 %), pigs (0.02 %), sheep and goats (0.11 %), poultry (0.15 %), eggs (0.40 %), rabbits (0.34 %) and farmed game (1.05 %). An important decrease has been observed in the frequency of non‑compliant samples for anticoccidials in poultry (0.16 % in 2013 and 0.15 % in 2012, compared to 0.22 % in 2011, 0.96 % in 2010 and 2.05 % in 2009). Non‑compliant samples were observed for ‘other pharmacologically active substances’ (B2f), in bovines (0.26 %), pigs (0.03 %) and poultry (0.14 %).

Instances of non-compliance for anthelmintics (B2a) were reported in bovines (0.04 %), pigs (0.07 %), sheep and goats (0.13 %) and milk (0.08 %). For pyrethroids (B2c), non‑compliant samples were for reported in pigs (0.04 %), aquaculture (0.29 %) and honey (0.12 %). Non‑compliant samples were reported for sedatives (B2d) in pigs (0.03 %). For non-steroidal anti-inflammatory drugs (B2e), non‑compliant samples were found in bovines (0.16 %), pigs (0.16 %), sheep and goats (0.63 %), horses (0.11 %), poultry (0.27 %) and milk (0.03 %).

In the group B3 (other substances and environmental contaminants), the chemical elements (B3c) had the highest overall percentage of non-compliant samples (3.9 %), with cadmium, lead, mercury and copper being most frequently identified. Non-compliant samples were reported for organochlorine compounds (B3a) and organophosphorus compounds (B3b); 0.16 % and 0.04 %, respectively. For mycotoxins (B3d), there were non‑compliant samples in bovines (4.0 %), pigs (0.96 %), horses (2.6 %) and milk (1.33 %). Those identified being, zearalenone and derivatives, ochratoxin A, aflatoxin B1 and aflatoxin M1. Prevalence of dyes (B3e) in aquaculture samples was lower in 2013 (1.14 %) compared to the previous six years (1.5 %–2.2 %). Substances found were brilliant green, malachite green, malachite green‑leuco, crystal violet and crystal violet‑leuco. No non‑compliant samples were noted for ‘other substances’ (B3f).

The overall frequency of non‑compliant samples in 2013 (0.31 %), was comparable to the previous six years (0.25 %–0.34 %). The frequency of non-compliant samples in 2013 was higher for stilbenes (A1), antithyroid agents (A2), beta‑agonists (A5), carbamates and pyrethyroids (B2c), chemical elements (B3c; mainly metals) and mycotoxins (B3d), compared to the previous six years. For resorcyclic acid lactones (A4) the number of non‑compliant samples had increased in 2013 compared to the previous 3 years. Non­compliant samples for anthelmintics (B2a) and dyes (B3e) were lower compared to previous years. No non‑compliant samples were reported in 2013 for ‘other substances’, however in the previous six years, non‑compliant sample frequencies ranged from 0.03 % to 0.21 %. In 2012 and 2013, the frequency of non‑compliant samples for steroids (A3) and anticoccidials (B2b) were comparable, however, lower compared previous years. Compared to 2012, lower frequencies of non‑compliant samples were noted for sedatives (B2d) and ‘other pharmacologically active substances’ (B2f). For the other substance groups, there were no notable variations over the seven years. The decrease in the frequency of non-compliant samples for anticoccidials is most likely the result of the awareness and the measures that followed the implementation of the Commission Directive 2009/8/EC setting up maximum levels of unavoidable carry-over of coccidiostats in non-target feed.

The sampling plans and the pattern of substances analysed are not necessarily the same every year and the prescribing patterns of veterinary medicines vary between species. Therefore, the outcome of the data analysis at EU level may not accurately reflect the residue situation in each individual EU Member State and for each species or product category.

Published
18. November 2015