The report summarises the data collected from the monitoring on the presence of residues of veterinary medicinal products and certain substances in live animals and animal products in the European Union, in 2011. Altogether, 742,902 samples were reported to the European Commission. They included 415,909 targeted samples and 23,236 suspect samples reported under Council Directive 96/23/EC, 4,329 samples checked at import and 299,428 samples collected in the framework of programmes developed under the national legislation. The minimum requirements for sampling frequency laid down in Council Directive 96/23/EC and in Commission Decision 97/747/EC were fulfilled by the vast majority of Member States. The percentage of non-compliant targeted samples (0.28 %) was slightly lower compared to the previous four years (0.32 % – 0.34 %). The difference was triggered by the lower frequency of non-compliant samples for steroids, resorcyclic acid lactones, prohibited substances, antimicrobials, anthelmintics and anticoccidials. Conversely, the proportion of non-compliant samples for chemical elements (mainly metals) was similar to 2010 and higher compared to the period 2007 - 2009. This development is explained by the application since 2010 of a stricter legal basis in the evaluation of compliance for mercury and copper thus resulting in more non-compliant samples. For other substance groups, there were no notable variations in the overall frequency of non-compliant samples over the past five years.
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. Maximum limits for residues of veterinary medicinal products in food-producing animals and animal products are established in Regulation (EU) No 37/2010. Maximum limits for the presence of certain contaminants in animal products are laid down in Commission Regulation (EC) 1881/2006. 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. The present report summarises the monitoring data from 2011 on the presence of residues of veterinary medicinal products and certain substances in live animals and animal products in the European Union (EU). Data were collected in aggregated form in a database managed by the European Commission (EC).
In the framework of Article 31 of Regulation EC 178/2002, the European Commission 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. 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 collected in aggregated form do not allow for an in-depth analysis. The limitations described in the previous EFSA reports (EFSA, 2010a; EFSA, 2010b; EFSA, 2011; EFSA, 2012) 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, 742,902 samples were reported by the 27 EU Member States in the framework of the residue monitoring in 2011. They included 415,909 targeted samples and 23,236 suspect samples reported under Council Directive 96/23/EC, 299,428 samples collected in the framework of other programmes developed under the national legislation and 4,329 samples checked at import. Considering all animal species and product categories included in the 2011 monitoring plans, 779 substances were listed to be checked for. The frequency of analyses for a certain substance is highly variable depending on the targeted animal/product category. 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, thus results on those samples were not pooled together with the results on targeted samples.
With regard to the minimum requirements for sampling frequency laid down in Council Directive 96/23/EC and in Commission Decision 97/747/EC, they were fulfilled by the vast majority of EU Member States.
Overall, 1,178 samples or 0.28 % of the 415,909 targeted samples were non-compliant in 2011. Similar to the previous four years, there were no non-compliant samples for stilbenes and derivatives (A1). For antithyroid agents (A2), there were 0.63 % non-compliant samples, all for thiouracil, most likely due to feeding diets rich in cruciferous plants. In the group of steroids (A3), there were 0.11 % non-compliant samples in all animal and product categories but only about half of them were non-compliant for anabolic steroids. The others were non-compliant for corticosteroids reported in the group A3. The non-compliant results for anabolic steroids (n = 32) were found in bovines (n = 17), pigs (n = 6), poultry (n = 6) and aquaculture (n = 3). For 80 % of the non-compliant results on anabolic steroids, Member States indicated that the source was most likely the endogenous production. Non-compliant results for corticosteroids were reported in group A3 (n = 29) and in B2f (n = 10). All but one of non-compliant results for corticosteroids (A3 and B2f) were reported in bovines (n = 38). In the group of resorcyclic acid lactones (A4), 0.08 % of the samples were non-compliant for zearalenone and derivatives. For beta-agonists (A5), there were 0.03 % non-compliant samples. Prohibited substances were found in 0.04 % of samples. Substances identified were chloramphenicol (n = 12), nitrofurans (n = 15) and nitroimidazoles (n = 2).
For antibacterials (B1), 0.19 % of the samples analysed under the Directive 96/23 monitoring were non-compliant. The highest frequency of non-compliant samples for antibacterials was found in honey (1.0 %).
In the group B2 (other veterinary drugs), the highest proportion of non-compliant samples was found for anticoccidials (0.26 %; B2b). Across animal species and product categories, the non-compliant samples for anticoccidials accounted for 0.22 % in poultry, 0.06 % in pigs, 0.12 % in sheep and goats, 1.1 % in rabbit meat, 2.5 % in farmed game and 0.72 % in eggs. An important decrease has been observed in the frequency of non-compliant samples for anticoccidials in poultry (0.22 % in 2011 compared to 0.96 % in 2010 and 2.05 % in 2009). Instances of non-compliance for anthelmintics (B2a) were reported in bovines (0.1 %), sheep and goats (0.21 %), poultry (0.03 %) and milk (0.18 %). There was one non-compliant sample for pyrethroids (B2c) and one for sedatives (B2d). For non-steroidal anti-inflammatory drugs (B2e), non-compliant samples were found in bovines (0.15 %), pigs (0.02 %), horses (0.66 %), poultry (0.34 %) and milk (0.09 %). Non-compliant samples for “other pharmacologically active substances” (B2f) were reported in bovines (0.1 %), sheep and goats (0.18 %), poultry (0.14 %) and rabbit (1.9 %).
Similar to previous years, in the group B3 (other substances and environmental contaminants), the chemical elements (B3c) had the highest overall percentage of non-compliant samples (3.4 %). Cadmium, lead, mercury and copper were the most frequent elements identified. Instances of non-compliance for organochlorine compounds (B3a) and organophosphorus compounds (B3b) were much lower: 0.17 % and 0.03 %, respectively. For mycotoxins (B3d), there were non-compliant samples for zearalenone and derivatives, ochratoxin A, aflatoxin B1 and aflatoxin M1 in milk. Important to highlight that by a relatively constant sampling frequency over time, the number of non-compliant milk samples for aflatoxin M1 (n = 13) was higher compared to the period 2008 to 2010 (n = 4 to 7). Prevalence of dyes (B3e) in aquaculture samples remained relatively high in 2011 (1.8 %), a value similar to those reported in the previous years. Substances found were malachite green, leuco malachite green, crystal violet and leuco crystal violet.
A comparison of the data from the period 2007 to 2011 highlighted that the overall frequency of non-compliant samples in 2011 was slightly lower compared to the previous four years (0.32 % – 0.34 %). For several substance groups, there were no notable variations in the frequency of non-compliant samples in 2011 compared to previous years but a decrease was observed for steroids, resorcyclic acid lactones, prohibited substances, antimicrobials, anthelmintics and anticoccidials. 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. In contrast, the proportion of non-compliant samples for chemical elements (mainly metals) was similar to 2010 but higher compared to the period 2007 to 2009. This development is explained by the application since 2010 of a stricter legal basis in the evaluation of compliance for mercury and copper.
The national sampling plans and the pattern of substances analysed were likely not the same over the years and the prescribing patterns of veterinary medicines vary between species. Therefore, the outcome of the data analysis at EU level may not reflect accurately the residue situation in each individual EU Member State and for each species or product category.
 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. OJ L 15/1, 20.1.2010, p. 1-72.
 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. OJ L 364/5, 20.12.2006, p. 5 – 24.
 Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC. OJ L 125, 23/05/1996, p. 10 – 32.
 Commission Decision 97/747/EC fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products. OJ L 303, 6.11.1997, p. 12–15.
 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31/1, 1.2.2002, p. 1-24.
 The number of substances included in the monitoring plan might be slightly different from the true number of substances analysed. Due to the structure of the data collection, it was not possible to extract the exact number of substances analysed.
 Commission Directive 2009/8/EC of 10 February 2009 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels of unavoidable carry-over of coccidiostats or histomonostats in non-target feed. OJ L 40/19, 11.2.2009, p. 19-25.