La Legislacin de EU en el tema residuos EU legislation on residues

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La Legislación de EU en el tema residuos EU
legislation on residues

• Dr. Roberto Piro
• Istituto Zooprofilattico Sperimentale delle
  Lombardia e dellEmilia Romagna
• rpiro_at_bs.izs.it

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Introduction

• Residues
• Limits
• Official Control
• EU Rapid Alert System
• Conclusion

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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

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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

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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

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The Limits
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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.

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• 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

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• 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

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Council Regulation EEC 2377/90
EMEA
CVMP
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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

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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.

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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 .

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ANNEX IV

• Aristolochia spp. and its preparation
• Chloramphenicol
• Chloroform
• Chloropromazine
• Colchicine
• Dapsone
• Dimetridazole
• Metronidazole
• Nitrofurans (furazolidone included)
• Ronidazole

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Veterinary drugEvaluated by EMEA
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AUTHORISED DRUGS
MLR
Authorisation
FORBIDDEN SUBSTANCES
NOT AUTHORISED DRUGS
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Official Control
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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

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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.

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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

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Veterinary drugs and Environmental contaminants
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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
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GROUP BVeterinary 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

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Group A / B Two Different Worlds
c
Group A
Group B
Approved Vet Drugs Environment contaminants
Chloramphenicol Nitrofurans

• Different sampling procedures
• Different analytical methods (LC-MS/MS)
• Different tolerance (zero tolerance)
• Different penalties

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Residue of authorised drugs

• Evaluation of the observance of the Maximum
  Residue Limit (MRL)

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Definition of Action Limit

• Safety for the consumer
• Reliability of analytical techniques used.
• Knowledge of metabolism or distribution kinetics.
  

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• For the forbidden drugs or not authorised
  substances a limit of action doesn't correspond
  in any case to authorise its use

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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.

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Residue of not authorised drugs (Group B - no
toxic)

• These limits are specified in the National
  Residues Monitoring Plan.
• There arent a uniform criteria for to define
  limits for this type of residue.
• The limit of detection of the analytical methods
  are often used.

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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),

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• The limit in this context is indicative, if a
  laboratory have best performances in terms of
  LoD, the sample must be to considered positive

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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

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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.

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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.

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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.

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Situation before Dec. 2002/657No - MRPL
LoD - ppb
Laboratories
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Definition of MPRL
LoD - ppb
MRPL
Laboratories
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Situation after Dec. 2002/657
LoD - ppb
MRPL
Laboratories
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Situation after Dec. 2002/657
MRPL
LoD - ppb
Laboratories
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Rapid Alert System
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Regulation EC/178/2002Rapid Alert System

• 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.

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Levels of Information

• Exist three levels of information
• Alert Notification
• Information Notification
• News

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Alert Notification

• 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

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Information Notification

• Conditions
• - Not immediate action required
• - Provide useful information
• Actions
• No Actions is required

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News

• Conditions
• - Neither Alert nor Information
• Actions
• No Actions is required

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FLOW-CHART OF ACTIVITIES CARRIED OUT BY
SANCO-RASFF
MEMBER STATE NOTIFICATION
E-MAIL
FAX
RASFF ASSESSMENT
NEWS
INFORMATION
ALERT
ELABORATION OF THE NOTIFICATION
TRANSMISSION VIA CIRCA/E-MAIL
TRANSMISSION OF NOTIFICATIONS TO THE THIRD
COUNTRIES CONCERNED
FEEDBACK FROM MEMBER STATES
REPORTS/ STATISTICS
COMMISSION SERVICES
MEMBER STATES
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• Alarm and Information
• 4-12 / 2003

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• Alarm and Information
• 1- 3 / 2004

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(No Transcript)
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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

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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.