Published on September 13, 2007
La Legislación de EU en el tema residuos EU legislation on residues: La Legislación de EU en el tema residuos EU legislation on residues Dr. Roberto Piro Istituto Zooprofilattico Sperimentale delle Lombardia e dell’Emilia Romagna [email protected] Introduction: Introduction Residues Limits Official Control EU Rapid Alert System Conclusion Background: Background The presence of the residues in the honey is an actual problem, The consumers and the beekeepers susceptibility on this subject increase rapidly, The legislation is complex and is not always complete, clear and homogeneous. Few specific laws for honey Residue Definition: Residue Definition Residues of veterinary medicinal products means all pharmacologically active substances, whether active principles, excipients or degradation products, and their metabolites which remain in foodstuffs obtained from animals to which the veterinary medicinal product in question has been administered; Regulation EEC 2377/90 Maximum Residue Limit: Maximum Residue Limit means the maximum concentration of residue resulting from the use of an approved veterinary medicinal product which may be accepted by the Community to be legally permitted or recognized as acceptable in or on a food Regulation EEC 2377/90 The Limits : The Limits Regulation CEE 2377/90: Regulation CEE 2377/90 define the European procedure for the determination of the Maximum Residue Limit (MRL) of veterinary drugs in animal origin foods (included honey) to introduce on the market a new veterinary drug is necessary to know the fate in the final food. Slide8: ANNEX I List of pharmacologically active substances for which maximum residue levels have been fixed ANNEX II List of substances not subject to maximum residue levels Slide9: ANNEX III List of pharmacologically active substances used in veterinary medicinal products for which maximum residue levels have been fixed ANNEX IV Lists of pharmacologically active substances for which no maximum levels can be fixed Council Regulation EEC 2377/90: Council Regulation EEC 2377/90 EMEA CVMP ANNEX II: ANNEX II Annex II includes not only safe and non toxic compounds, but also some combination (drug + device/formulation) that do not produce residues and risk for the consumer: tau-Fluvalinate (Apistan) Reg. 2034/96 Flumetrine (Bayvarol) Reg. 2686/98 (Bovine and ovine Annex I) Strychnine Reg. 804/99 Annex II - no MRL Thymol: Annex II - no MRL Thymol is natural component of the diet; is widely used as food additive; is rapidly metabolized and eliminated; the residues of thymol in animal products are not likely to be of toxicological concern to humans. Annex II - no MRL tau Fluvalinate: Annex II - no MRL tau Fluvalinate NOEL 0.5 mg/kg bw/day - ADI 0.5 mg/kg bw LoD 10 ppb tau Fluvalinate is stable in honey and wax; Considerable accumulation of tau Fluvalinate was observed in wax 0.2 -5.5 ppm (max 26.9 ppm near the strip); ...... residues in wax increase exponentially when wax was reused over the years; Transfert of tau Fluvalinate residues from wax to honey was shown to be negligible; Considering that following treatment of bees with the intended pharmaceutical formulation and dose as well 4 time the intended dose at prolonged treatment period residues of tau Fluvalinate in honey were always below the LoD of analytical method, it is concluded that it is not necessary to establish a MRL for tau Fluvalinate . ANNEX IV: ANNEX IV Aristolochia spp. and its preparation Chloramphenicol Chloroform Chloropromazine Colchicine Dapsone Dimetridazole Metronidazole Nitrofurans (furazolidone included) Ronidazole Veterinary drugEvaluated by EMEA : Veterinary drug Evaluated by EMEA Slide16: AUTHORISED DRUGS Authorisation FORBIDDEN SUBSTANCES MLR NOT AUTHORISED DRUGS Official Control: Official Control Council Directive 96/23/EC : Council Directive 96/23/EC 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 + Council Decision 97/747/ CE Council Directive 96/23/EC: Council Directive 96/23/EC Guidelines for residues control in animals and in their products (included honey). detailed procedures to set up a National monitoring plan; detail on sampling procedures; any type of animal or food have a definite set of categories substance that must be monitored. Definitions Directive 96/23/EC: Definitions Directive 96/23/EC unauthorized substances or products: shall mean substances or products the administering of which to animals is prohibited under Community legislation; illegal treatment: shall mean: the use of unauthorized substances or products or the use of substances or products authorized under Community legislation for purposes or under conditions other than those laid down in Community legislation or, where appropriate, in the various national legislations Slide21: Veterinary drugs and Environmental contaminants GROUP A Substances having anabolic effect and unauthorized substances: GROUP A Substances having anabolic effect and unauthorized substances (1) Stilbenes, stilbene derivatives, and their salts and esters (2) Antithyroid agents (3) Steroids (4) Resorcylic acid lactones including zeranol (5) Beta-agonists (6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 Hormones and grow promoters GROUP BVeterinary drugs and contaminants: GROUP B Veterinary drugs and contaminants Antibacterial substances, including sulphonomides, quinolones Other veterinary drugs (a) Anthelmintics (b) Anticoccidials, including nitroimidazoles (c) Carbamates and pyrethroids (d) Sedatives (e) Non-steroidal anti-inflammatory drugs (NSAIDs) (f) Other pharmacologically active substances Other substances and environmental contaminants (a) Organochlorine compounds including PCBs (b) Organophosphorus compounds (d) Chemical elements (d) Mycotoxins (e) Dyes (f) Others Group A / B Two Different Worlds: Group A / B Two Different Worlds Different sampling procedures Different analytical methods (LC-MS/MS) Different tolerance (zero tolerance) Different penalties c Group A Group B Chloramphenicol Nitrofurans Approved Vet Drugs Environment contaminants Residue of authorised drugs: Residue of authorised drugs Evaluation of the observance of the Maximum Residue Limit (MRL) Definition of Action Limit: Definition of Action Limit Safety for the consumer Reliability of analytical techniques used. Knowledge of metabolism or distribution kinetics. Slide27: For the forbidden drugs or not authorised substances a limit of action doesn't correspond in any case to authorise its use General limits: General limits In many countries a general limit exist (I, D), and is used when no limits are defined. This limit is generally 0,01 mg/kg (10 ppb), close to a generic (old) instrumental detection limits. Slide29: Residue of not authorised drugs (Group B - no toxic) These limits are specified in the National Residues Monitoring Plan. There aren’t a uniform criteria for to define limits for this type of residue. The limit of detection of the analytical methods are often used. Residue of forbidden drugs(Group A): Residue of forbidden drugs (Group A) Zero tolerance The action limit is generally fixed at 1 ppb, Recently the EC request a very low limit of detection (MRPL = 0,3 ppb for chloramphenicol), Slide31: The limit in this context is indicative, if a laboratory have best performances in terms of LoD, the sample must be to considered positive Commission Decision 2002/657/EC: Commission Decision 2002/657/EC (12 August 2002) Implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results Commission Decision 2002/657/EC (1): Commission Decision 2002/657/EC (1) It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control. Commission Decision 2002/657/EC (2): Commission Decision 2002/657/EC (2) It is necessary to determine common criteria for the interpretation of test results of official control laboratories in order to ensure a harmonised implementation of Directive 96/23/EC. Minimum Required Performance Limits: Minimum Required Performance Limits It is necessary to provide for the progressive establishment of Minimum Required Performance Limits (MRPL) of analytical method for substances for which no permitted limit has been established and in particular for those substances whose use is not authorised, or is specifically prohibited in the Community, in order to ensure harmonised implementation of Directive 96/23/EC. Situation before Dec. 2002/657No - MRPL: Situation before Dec. 2002/657 No - MRPL Laboratories LoD - ppb Definition of MPRL: Definition of MPRL MRPL LoD - ppb Laboratories Situation after Dec. 2002/657: Situation after Dec. 2002/657 MRPL LoD - ppb Laboratories Situation after Dec. 2002/657: Situation after Dec. 2002/657 MRPL LoD - ppb Laboratories Rapid Alert System: Rapid Alert System Slide41: Notification of a direct or indirect risk to human health from food or feed. Network involving member states, the Commission and the European Food Safety Authority (EFSA). The information from a member of the network shall be immediately notified to the Commission and then through the network. The EFSA may supplement the notification with any scientific or technical information. Regulation EC/178/2002 Rapid Alert System Slide42: Exist three levels of information: Alert Notification Information Notification News Levels of Information Slide43: Conditions - Food on the market - More than one Member State (MS) - Immediate action is required (real risk) Actions Triggered by MS/EFSA (receive from Contact Points and evaluated by RASFF team in SANCO) - Withdrawal of product from the market Alert Notification Slide44: Conditions: - Not immediate action required - Provide useful information Actions No Actions is required Information Notification Slide45: Conditions: - Neither Alert nor Information Actions No Actions is required News Slide46: FLOW-CHART OF ACTIVITIES CARRIED OUT BY SANCO-RASFF NEWS MEMBER STATE NOTIFICATION RASFF ASSESSMENT FEEDBACK FROM MEMBER STATES TRANSMISSION VIA CIRCA/E-MAIL ELABORATION OF THE NOTIFICATION INFORMATION ALERT TRANSMISSION OF NOTIFICATIONS TO THE THIRD COUNTRIES CONCERNED MEMBER STATES COMMISSION SERVICES E-MAIL FAX REPORTS/ STATISTICS Slide47: Alarm and Information 4-12 / 2003 Slide48: Alarm and Information 1- 3 / 2004 Slide49: Conclusions: Conclusions Residues is the greatest problem for beekeeping, The rules and the legislation for residues change continuously and rapidly, The authorisation of new veterinary products will be subjected to more restrictive rules Conclusions: Conclusions Residues of forbidden substances in honey (CAP, Nitrofurans) has broke down irremediably the confidence in honey as safe and natural product. Analytical methods and limits of action need to be harmonized.