European Union residue limits

A unique feature of the development of veterinary medicines for food-producing species is the need to consider the establishment of Maximum Residue Limits (M RLs) for the drug or its metabolites in food produce. A MRL is defined in the European Union as ... 

The Community procedure for establishing MRLs of veterinary medicines in foodstuffs of animal origin is set down in Council Regulation (EEC) No. 2377/90 as amended by Council Regulation (EC) No. 1308/1999. The regulations are supported by detailed guidance contained in The Rules Governing Medicinal Products in the European Union, Volume 8 - Maximum Residue Limits. 

The Rules Governing Medicinal Products in the European Union, Volume 8 -Maximum Residue Limits... 

For example, in order to meet the demanding requirements of legislation such as the European Union (EU) Baby Food Directive (Directive 95/5/EC and subsequent revisions), analysts must improve on the scope and sensitivity of multiresidue methods of analysis. This Baby Food Directive, which became effective on 1 July 2002, limits residues of all pesticides to a maximum level of 0.01 mgkg There will also be a banned list of pesticides, annexed to the Directive, which will not permit the use of certain pesticides on crops intended for use in baby food production. As a consequence, food manufacturers often require residue results for raw or primary ingredients within 24 8 h of sample receipt at the laboratory. 

Oxytetracycline is a broad-spectrum antibiotic, which has been used worldwide in veterinary medicine and in aquaculture for the prevention and treatment of disease and as feed additives to promote growth. The maximum residue limits (MRLs) of OTC and relative substances as described by the US Food and Drug Administration [66] and European Union [67] are presented in Table 4. 

To safeguard human health, the European Union (EU) has established safe maximum residue limits (MRLs) for residues of veterinary drugs in animal and food samples (2,3). The Council Directive 96/23/EU has established numbers of samples to be tested for each compound group (4). 

European Union regulation foresees a maximum residue limit (MRL) for dichlorvos in durum wheat at 2.0 pg/g [4], Dichlorvos is also classified as a probable human carcinogen on the basis of the effects observed in mice and rats. Therefore, the U.S. Environmental Protection Agency (EPA) proposed cancellation of most uses of dichlorvos and proposed... 

There are many chemical contaminants that may be present in a vast array of different foodstuffs. This highlights the need for an extremely flexible, sensitive, and rapid analytical methodology capable of detection of multianalyte in various food samples. Such systems should be capable of detecting the residues of the parent compound and its metabolites in various sample matrices. This may be facilitated in the future by multiplex antibody microarrays, possibly integrated with label-free methods. Flowever, within the European Union (EU) there is no obligation to use standardized methods in residue control studies on food-producing animals. Techniques are required to satisfy new performance characteristics, limits, and other criteria, opening the door for modern analytical approaches such as antibody microarrays [42]. 

European Union Maximum Residue Limits Reports, (available at http //www.ema.europa.eu/ema/index.jsp curl=pages/medicines/landing/vet mrl search. jsp murl=menus/regulations/regulations.jsp mid=WC0b01ac058006488e accessed 11/29/10). 

The LOD was calculated by multiplying the average value of the noise sampled at the retention time of each analyte by and the limit of quantification was ten times the average value of the noise in this same region. The detection limit found was 0.1 p.g/L, and the quantification limit was 0.3 p.g/L. It is possible to determine fipronil residues in water at a concentration similar to the European Union maximum admissible, 0.1 Rg/L.t i ... 

With the extensive use of drugs in animal production, violative residues of the parent drugs and/or metabolites have a high potential to be present in meat, milk, eggs, and honey. The level of residues and the individual drugs they originate from determine the public health significance of such an adulteration of the food supply. The European Union (EU) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) have established maximum residue limits (MRLs) for several quinolones. 

Finally, even if most of the pesticides worldwide are used in fruit and vegetable crops, data on pesticide residues in animal products are also essential, taking into account that livestock can be easily exposed to pesticides directly or through residues in their feed. For instance, the 2009 European Union Report revealed the presence of 34 different pesticides in animal products [115]. Garcfa de Llasera et al. [128] revealed the presence of chlofenvinphos and chlorpyrifos in liver samples, whereas a-endosnlfan, endosulfan sulfate, and dichloran have been reported in pork and lamb samples (<10 pg/kg) [129]. Bolafios et al. [130] studied the occurrence of organochlorine pesticides and polychlorinated biphenyls in chicken eggs. Benzene hexachloride and 28 polychlorinated biphenyl were detected in only one of the 30 samples at concentrations of 15 and 10 ng/g, respectively. However, five samples also contained traces of OC and PCB residues, even if at concentration levels below the limit of quantification. Einally, a-endosulfan and P-endosulfan were found in commercial milk-based infant formulas at concentration levels from 1.18 to 5.03 pg/kg [35]. The same study also showed the presence of fenitrothion, chlorpyrifos ethyl, and bifenthrin at maximum concentrations of 0.23,1.30, and 0.68 pg/kg, respectively. 

In veterinary medicine, the main tetrahydropyrimidine drugs are pyrantel and morantel. Pyrantel is used widely in horses as the pamoate (embonate a naphthoic acid derivative) salt and it is active against a range of roundworms. As the tartrate and citrate, it is used in cattle, sheep and pigs in some countries. However, in the European Union (EU), the maximum residue limit (MRL) only covers the use in horses. Morantel, usually as the citrate or tartrate is used to treat parasitic infestations in a number of species. Pyrantel, in combination with ivermectin is used to treat susceptible parasites in dogs and in combination with praziquantel (see section 12.2.7), parasites in cats and dogs. Oxantel, in combination with pyrantel and praziquantel is used to treat parasitic disease in... 

Chlorpromazine was used in food animals in the European Union (EU). When the information was reviewed in order to establish maximum residue limits (MRLs) for the drug, it was concluded that there were insufficient data to allow the identification of a no-observed effect level and no acceptable daily intake could be calculated. Hence, the drug was prohibited for use in food animals in the EU. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) considered MRLs for chlorpromazine and another phenothiazine drug propionylpromazine. It too considered the available data to be inadequate and was unable to establish MRLs for either compound. 

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