The present report summarises the monitoring data collected in 2012 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 772,540 samples were reported to the European Commission by the 27 EU Member States. They consisted of 427,193 targeted samples and 23,102 suspect samples reported under council Directive 96/23/EC, 4,164 samples collected at import and 318,081 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 (0.25 %) was slightly lower compared to the previous five years (0.28 – 0.34 %). A lower frequency of non compliant samples was reported in 2012 for antithyroid agents, steroids, resorcyclic acid lactones, antibacterials, anticoccidials and carbamates and pyrethroids compared to the previous five years. The proportion of non compliant samples for chemical elements (mainly metals) in 2012 was higher compared to 2007, 2008 and 2009, but lower compared to 2010 and 2011. For the other substance groups, there were no notable variations over the six 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.
The present report summarises the monitoring data from 2012 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.
ommission 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) 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, 772,540 samples were reported by the 27 EU Member States in the framework of the residue monitoring in 2012. They consisted of 427,193 targeted samples and 23,102 suspect samples reported under Council Directive 96/23/EC, 318,081 samples collected in the framework of other programmes developed under the national legislation and 4,164 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 27 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 1,071 samples (0.25 %) out of the 427,193 target samples were non-compliant in 2012.
Similarly to the previous five years, there were no non-compliant samples for stilbenes and derivatives (A1). For antithyroid agents (A2), there were 0.33 % non-compliant samples, all for thiouracil, most likely due to feeding diets rich in cruciferous plants. In the group of steroids (A3), there were 0.09 % non-compliant samples in all animal and product categories. The non-compliant results for steroids (n = 40) were found in bovines (n = 4), pigs (n = 31), aquaculture (n = 4) and farmed game (n = 1). 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 2012. In the group of resorcyclic acid lactones (A4), 0.07 % of the samples were non-compliant for zearalanone and derivatives. For beta-agonists (A5), there were 0.01 % non-compliant samples. Prohibited substances (A6) were found in 0.05 % of samples. Substances identified were chloramphenicol (n = 16), nitrofurans (n = 11) and nitroimidazoles (n = 8).
For antibacterials (B1), 0.18 % 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 (1.5 %).
In group B2 (other veterinary drugs), the highest proportion of non-compliant samples was found for “other pharmacologically active substances” (0.26 %; B2f), this value is higher than previous years and is considered to be due to the Member States reporting authorised corticosteroids under this group only, in 2012.
For anticoccidials (B2b), the percentage of non-compliant samples was lower in 2012 (0.15 %) compared to the previous five years (0.26 % - 1.6 %). Across the different species, the non-compliant results were reported as follows; in pigs (0.03 %), horses (1.25 %), poultry (0.16 %), eggs (0.35 %), rabbits (0.34 %) and farmed game (1.18 %). An important decrease has been observed in the frequency of non-compliant samples for anticoccidials in poultry (0.15 % in 2012 compared to 0.22 % in 2011, 0.96 % in 2010 and 2.05 % in 2009). Instances of non-compliance for anthelmintics (B2a) were reported in bovines (0.02 %), pigs (0.04 %), sheep and goats (0.36 %), horses (0.40 %), aquaculture (0.29 %), milk (0.09 %), rabbits (0.64 %) and farmed game (0.39 %). There were no non-compliant samples for pyrethroids (B2c). Non-compliant samples (0.05 %) were reported for sedatives (B2d) in bovines, pigs and horses. For non-steroidal anti-inflammatory drugs (B2e), non-compliant samples were found in bovines (0.11 %), pigs (0.05 %), horses (1.58 %), poultry (0.34 %), milk (0.09 %) and rabbits (1.08 %).
In the group B3 (other substances and environmental contaminants), the chemical elements (B3c) had the highest overall percentage of non-compliant samples (2.9 %), with cadmium, lead, mercury and copper being most frequently identified. Non-compliant samples were reported for organochlorine compounds (B3a) and organophosphorus compounds (B3b); 0.21 % and 0.04 %, respectively. For mycotoxins (B3d), there were non-compliant samples for zearalenone and derivatives in bovine and pigs, ochratoxin A in pigs, aflatoxin B1 in bovines and pigs and aflatoxin M1 in milk. Prevalence of dyes (B3e) in aquaculture samples remained relatively high in 2012 (1.95 %), a value slightly higher compared to the previous four years. Substances found were malachite green, leuco malachite green, crystal violet and leuco crystal violet.
The overall frequency of non-compliant samples in 2012, was slightly lower (0.25 %) compared to the previous five years (0.28 % - 0.34 %). For several substance groups there were no notable variations in the frequency of non-compliant samples in 2012 compared to previous years. However, a decrease was observed for antithyroid agents (A2), steroids (A3), resorcyclic acid lactones (A4), antibacterials (B1), anticoccidials (B2b) and carbamates and pyrethroids (B2c). The proportion of non-compliant samples for chemical elements (mainly metals) in 2012 was higher compared to 2007, 2008 and 2009, but lower compared to 2010 and 2011. 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.