T.C.
TARIM ve KÖYİŞLERİ BAKANLIĞI
Koruma ve Kontrol Genel Müdürlüğü
Regulation regarding the measures to be taken for monitoring certain substances and the residues thereof in live animals and animal products
PART ONE
General Provisions
CHAPTER ONE
Objective, Scope, Legal basis and Definitions
Objective
Article 1- The objective of this Regulation is to determine the procedures and principles regarding the monitoring of certain substances and the residues thereof in live animals and primary animal products in order to protect consumer health by ensuring food safety.
Scope
Article 2- This Regulation covers certain substances and searching for the residues of such substances in live animals and primary animal products, the responsibilities of related institutions, establishments and persons as well as the proceedings in case of non-compliance to the provisions of this Regulation.
Legal basis
Article 3- This Regulation has been prepared on the basis of; Decree Law No. 441 dated 7/8/1991 on the Establishment and Responsibilities of the Ministry of Agriculture and Rural Affairs, Law No. 3285 dated 8/5/1986 on Animal Health and Surveillance, Law on the adoption of the amendment to the Decree Law No. 5179 dated 27/5/2004 on the Production, Consumption and Inspection of Food, Law No. 1380 dated 22/03/1971 on Fishery Products, Law No. 1734 dated 29/5/1973 on Animal Feed, and Law No. 1262 on Pharmaceutics and Medicinal Products.
This Regulation “has been prepared according to the measures for the monitoring of certain substances and the residues thereof in live animals and animal products and EU Directive No. 96/23/EC dated April 26 1996 repealing Directives no. 85/358/EEC and 86/469/EEC and Decisions no. 89/187/EEC and 91/664/EEC.
Article 4- For the purposes of this Regulation the following definitions shall apply;
a) Ministry: the Ministry of Agriculture and Rural Affairs,
b) Unauthorized substances or products: substances or products the administering of which to animals is prohibited according to the relevant legislation,
c) Illegal treatment: the use of unauthorized substances or products or the use of substances or products authorized under relevant legislation for purposes or under conditions other than those laid down in relevant legislation,
d) Residue: a residue of substances having a pharmacological action, of their metabolites and of other substances transmitted to primary animal products and likely to be harmful to human health,
e) Competent authority: the central authority and local establishments to be assigned by the Ministry for the implementation of the provisions of this Regulation,
f) Competent central authority: the General Directorate authorized by the Ministry for the implementation of this Regulation,
g) Competent local authority: Provincial directorates of the Ministry,
h) Official sample: a sample taken by the competent authority which bears, for the purpose of analyzing the residues or substances listed in Annex I, a reference to the species, the quantity of the sample, the method of collection and the sex of the animal as well as the origin of the animal or of the primary animal product,
ı) Authorized laboratory: a laboratory authorized by the Ministry for the analysis of an official sample in order to detect the presence of residues,
j) Reference laboratory: laboratories, assigned by the Ministry, responsible for determining the methods of analysis and standards, setting them up at the laboratories, controlling them and if necessary verifying the analysis performed by the authorized laboratories,
k) Animal: Bovine, ovine, caprine, porcine, soliped, bee, poultry, aquaculture animals and rabbits and wild game animals,
l) Batch of animals: a group of animals of the same species, in the same age range, reared on the same holding, at the same time and under the same conditions of rearing,
m) Primary animal product: unprocessed products such as meat, milk, eggs, honey directly obtained from animals,
n) Beta-agonist: a beta adrenoceptor agonist.
CHAPTER TWO
Residue Monitoring Plan to be implemented for the Detection of Certain Substances and the Residues Thereof
Substances to be monitored within the scope of the residue monitoring plan
Article 5- The production process of animals and primary products of animal origin shall be monitored in accordance with the provision laid out in this Chapter for the purpose of detecting the presence of the residues and substances listed in Annex I in live animals, their excrement and body fluids and in tissue, animal products, animal feed and drinking water.
Responsibilities of the Central Competent Authority
Article 6- The Central Competent Authority shall be responsible for:
a) Drawing up the plans provided for in Article 7 to ensure that the required inspections are carried out,
b) Coordinating the activities of the Ministerial institutions responsible for the monitoring of residues; ensuring that such coordination is extended to cover all units working to prevent the fraudulent use of substances or products on stock farms,
c) Collecting the data necessary for evaluating the methods used and results obtained in carrying out the measures provided for in this Chapter,
d) Sending to all related places at the latest by March 31 of each year, the data and results referred to in paragraph (c), including the results of any research carried out, as well as the annual plans drawn up according to Article 7 and amended according to Article 10.
Drawing up the residue monitoring plan and its framework
Article 7- The central competent authority sets out the national measures, prepares an updated plan according to the results of the measures implemented during the previous years and submits it to related places.
This plan shall:
a) Provide the detection of groups of residues or substances according to type of animal, in accordance with Annex II,
b) Specify in particular the measures for detection of the presence of the following:
1) The substances referred to in paragraph (a) of this Article, in the animals, in the drinking water of the animals and in all places where animals are bred or kept,
2) Residues of substances referred to in paragraph (a) of this Article, in live animals, their excrement and body fluids and in animal tissues and primary animal products such as meat, milk, eggs and honey,
c) Comply with the sampling rules and levels laid down in Annexes III and IV.
The sampling level and frequency of the residue monitoring plan
Article 8 – The plan must conform to the sampling levels and frequencies laid down in Annex IV. However, the plan may include disparities provided that it is clearly established that such disparities increase the overall effectiveness of the plan and do no reduce the ability to identify residues of substances listed in Annex I, or cases of illegal treatment with the said substances.
Issues provided for in the residue monitoring plan
Article 9- The plan shall be drawn up by taking into account the national conditions and shall cover the following:
a) Legislation on the use of the substances listed in Annex I and, in particular, provisions on their prohibition or authorization, distribution and placing on the market and the rules governing their market inspection.
b) The infrastructure of the relevant organizations and institutions, particularly the details regarding legal status and capacity,
c) A list of authorized laboratories including the details of their capacity for processing samples,
d) The national tolerance level to be determined for an authorized product, in cases where the maximum residue levels have not been specified,
e) A list of the substances to be detected, methods of analysis, standards for interpreting the findings and in the case of detection of the presence of substances listed in Annex I, the number of samples to be taken, giving the reasons for this number,
f) The number of official samples to be taken in relation to the number of animals of the species concerned slaughtered in preceding years in accordance with the sampling levels and frequencies laid down in Annex IV,
g) Details of the rules governing the collection of official samples, and in particular the rules concerning the particulars to appear on such official samples,
h) The type of measures laid down by the competent authority with regard to animals or products in which residues have been detected.
Amendments in the residue monitoring plans
Article 10- In order to take account of situational changes of the results of national surveys or researches carried out in the framework of Article 18 and 19, amendments can be made by the central competent authority in the plan prepared according to the first paragraph of Article 7.
The central competent authority announces the results of the implementation to relevant institutions and to the public once every six months.
PART TWO
Special Provisions
CHAPTER ONE
Self-inspection and responsibilities of operators
Conditions to be guaranteed by operators
Article 11- The following conditions must be ensured:
a) Any farms which place farm animals on the market and any natural or legal person engaged in trade in such animals shall be registered beforehand by the Ministry.
b) The owners or persons in charge of the establishment of initial processing of primary products of animal origin shall take all necessary measures, in particular by carrying out their own checks in the framework of the following issues:
1) The producer of animals distributed by direct delivery of through an intermediary shall guarantee that withdrawal time has been observed in these animals.
Satisfy themselves that the farm animals or products brought into the establishment
aa) Do not contain residue levels which exceed the maximum permitted limits,
İzin verilmiş olan maksimum limitleri aşan miktarda kalıntı seviyelerini içermemesi,
ab) Do not contain any trace of prohibited substances or products,
c-1) The producers or persons in charge referred to in paragraphs (a) and (b) of this Article may place on the market only provided that they ensure the following conditions:
aa) Unauthorized substances and products have not been administered to animals, or animals have not been subjected to illegal treatment,
İzinsiz maddelerin veya ürünlerin hayvanlara tatbik edilmediğini veya bu Yönetmelik kapsamında hayvanların izin verilmeyen uygulamaya tabii tutulmadığı;
ab) in case authorized substances or products have been administered to animals, prescribed withdrawal periods must have been observed,
ac) products derived from the animals referred to in (aa) and (ab),
c-2) Where an animal is presented at a first-stage processing establishment by a natural or legal person other than the producer, the obligations laid down in point 1 of this Article are imposed on the natural or legal person presenting the animal at the establishment
d) For the purposes of applying the issues laid down in paragraphs (a), (b) and (c) of this Article, the requirements specified below must be met without prejudice to compliance with the rules laid down in the regulations governing the placing on the market of the products.
1) The principles of quality monitoring laid down in relevant legislation concerning the different stages of the production chain must be met.
2) The self-inspection measures to be included in the specifications for trade mark or labels must be fortified.
Records to be kept on farms
Article 12- The terms of reference and responsibilities of veterinarians monitoring farms may be extended to monitoring the rearing conditions and forms of treatment referred to in this Regulation.
Within this framework, the veterinarian shall enter in a register kept on the farm, the date and nature of any treatment prescribed or administered, the identification of the animals treated and the corresponding withdrawal periods.
The stockfarmer shall enter in the register, if provided in the legislation regarding the usage of veterinary medicinal products, the date and nature of the treatment administered. The stockfarmer shall keep for five years the records showing that the withdrawal periods have been observed and the prescriptions to prove it.
The stockfarmer and veterinarian shall supply any information, at their request, to the Ministry’s official veterinarian and particularly the veterinarian of the slaughterhouse, regarding the farm’s compliance with this Regulation.
CHAPTER TWO
Official Control Measures
The scope of the controls to be carried out by the competent authority
Article 13 – Without prejudice to the controls carried out in connection with implementation of the monitoring plans referred to in Article 7 or to the obligations regarding the control provided for in other legislation, the competent authority may conduct official random controls as specified below:
During all stages involving the processing, storage, transportation, sale or acquisition of the substances in Group A of Annex I,
At any point in the animal feedstuff production and distribution chain,
Throughout the production chain of animals and raw materials of animal origin covered by this Regulation.
The controls provided for in paragraph 1 must be carried out particularly in order to detect the usage of prohibited substances or products administered to animals for the purposes of fattening or illegal treatment.
Where fraud is suspected, and in the case of a positive result from any of the controls referred to in paragraph 1, Articles 18, 19, 20 and 21 as well as the measures provided for in Chapter Three shall apply.
The controls provided for at the slaughterhouse or on the first sale of aquaculture animals and fishery products can be reduced, taking into account the fact that the farm of origin or departure belongs to a quality monitoring system or an epidemiological monitoring network as referred to in paragraph (d) of Article 11.
Obligations during the controls
Article 14 – The controls provided for in this Regulation are carried out by the competent authorities without any need for prior notice.
The owner, the person empowered to dispose of the animals or their representative shall be obliged to facilitate pre-slaughter inspection operations, and in particular to assist the official veterinarian or the authorized staff in any manipulation judged necessary.
Controls to be carried out by the competent authority
Article 15 – The competent authority shall:
Where illegal treatment is suspected, ask the owner or person in charge of the animals or the veterinarian in charge of the farm to provide any documentation justifying the nature of the treatment.
Where this investigation confirms illegal treatment or where unauthorized substances or products have been used, or where there are grounds for suspecting their use, carry out the following:
On site controls on animals on their farms of origin or departure, particularly in order to detect such usage and any traces of implants; these controls may include official sampling.
Controls to detect substances the use of which is prohibited or of unauthorized substances or products on the farms where the animals are being reared, kept or fattened, including holdings administratively connected with such farms, or on the animals’ farms of origin or departure. The competent authority shall take official samples of drinking water and feedstuff for this purpose.
On site controls on animals’ feedstuff on their farms of origin or departure, and on their drinking water or from the waters in which aquaculture animals are caught.
Controls provided for in sub-paragraph (a) of the first paragraph of Article 13.
Any control required for clarifying the origin of the unauthorized substances or products or the origin of the treated animals.
Where maximum residue levels have not been determined and tolerance levels have been exceeded, carry out any measure or research considered appropriate regarding the finding in question.
Designating national reference laboratories and their responsibilities
Article 16 – The Ministry shall designate one national reference laboratory for each residue or residue group. One residue or residue group shall not be assigned to more than one national reference laboratory. A list of designated laboratories shall be communicated in written form to the relevant units.
The responsibilities of the National Reference Laboratories are stated below:
Coordinating the work of other national laboratories responsible for residue analysis, particularly by coordinating the standards and methods of analysis for each residue or residue group concerned.
Assisting the competent authority in organizing the residue monitoring plan.
Periodically organizing comparative tests for each residue or residue group assigned to them.
Ensuring that national laboratories observe the limits determined.
Disseminating all kinds of information obtained.
Making a proposal for their personnel to participate further training courses organized by national and international institutions or laboratories
Authorized laboratories
Article 17 – During the analysis carried out by the authorized laboratories:
Official samples must be taken in accordance with Annex III and IV in order to be examined in authorized laboratories. The detailed rules for official sampling and the routine and reference methods of analysis to be employed shall be specified in accordance with international rules.
Whenever an authorization is issued for the placing on the market of a veterinary medicinal product intended for administration to a species the meat or product of which is intended for human consumption, the Ministry shall forward the methods employed for the analysis of residues to the national reference laboratories and to all concerned parties.
For substances included in Group A of Annex I, all positive findings recorded following the application of a routine method instead of a reference method must be confirmed by an authorized laboratory using the reference methods laid down in accordance with paragraph (a) of this Article.
For all substances, if there is a case of objection to the result of the analysis, those results must be confirmed by the national reference laboratory designated in accordance with paragraph 1 of Article 16 for the substance or residue in question and all costs must be covered by the plaintiff.
Where examination of an official sample reveals illegal treatment, in addition to those specified in Chapter Three, Article 18, 19, 20 and 21 shall apply.
Where the examination reveals the presence of residues of authorized substances or contaminants exceeding the levels set, Articles 20 and 21 shall apply.
Where the examination in question covers animals or products that are of an origin other than Turkey, the Ministry shall inform the competent authority of the country of origin of the request for the measures to be taken. Application of the measures provided for in paragraph (b) of Article 18, Article 19, 20 and 21 and Chapter Three, to the farm or establishment of origin or departure may be requested from the competent authority of the country of origin.
Positive samples
Article 18 – Where positive results are obtained as described in Article 17, the following provisions shall apply.
The competent authority shall provide without delay all the necessary information and all details of the result of the examination required to identify the animal and farm of departure or origin. If the controls carried out in Turkey reveal the need for an investigation or other action in one or more other countries, the Ministry shall inform the parties concerned. Where an investigation or other action proves necessary, the measures to be taken shall be carried out in the framework of the agreements met with the states concerned.
Where the competent authority has to carry out an investigation on the farm of origin or departure to determine the reasons for presence of residues and in the case of illegal treatment; a detailed investigation aimed at finding the source or sources of the substances or products concerned at the stage of production, processing, storage, transportation, administration, distribution or sale.
Animals from which samples have been taken are identified and the animals are under no circumstances allowed to leave the farm until the results of the controls are obtained.
Detection of illegal treatment
Article 19 – Where illegal treatment is established as a result of the investigations specified in paragraph (b) of Article 15, the competent authority shall place the animals under official control. The competent authority must ensure that all the animals concerned bear an official mark or identification and that, as a first step, an official sample is taken from a statistically representative sample, on internationally recognized scientific bases.
Exceeding the maximum residue limits
Article 20 – If it is established that the maximum residue limits are exceeded;
Where there is evidence that residues of authorized substances or of products exceed the maximum residue limits, the competent authority shall carry out an investigation in the farm of origin or departure in order to determine why the limits were exceeded.
In compliance with the results of that investigation, the competent authority shall take all necessary measures to safeguard public health, which includes prohibiting animals from leaving the farm concerned or products from leaving the farm or establishment concerned for a specific period.
In the event of repeated infringements of maximum residue limits when animals are placed on the market by a farmer, or products are placed on the market by a farmer or a processing establishment, intensified controls on the animals and products from the farm and/or establishment in question must be carried out by the competent authority for a period of at least six months, products or carcasses being impounded pending the results of analysis of the samples.
Any results showing that the maximum residue limit has been exceeded must lead to the carcasses or products concerned being declared unfit for human consumption.
Bearing the costs
Article 21 – The costs of the investigations and controls referred to in Article 18 shall be borne by the owner or person in charge of the animals.
Where the investigation justifies the suspicion, the costs of analysis conducted according to Articles 19 and 20 shall be borne by the owner or the person in charge of the animals.
Without prejudice to criminal or administrative penalties, the cost for the destruction of animals, which gave positive result, or animals that are accepted as positive according to Article 25 shall be borne, without indemnity or compensation, by the owner or person in charge of the animals.
Informing the countries to which exportation is made
Article 22 – Where a country of exportation informs the competent authority of Turkey that the controls provided for in this Regulation are not, or have ceased to be, carried out, the competent authority shall, subsequent to an investigation conducted in accordance with paragraph (b) of Article 18, take all measures and inform as soon as possible the competent authority of the country of exportation the reasons for those measures.
Controls to be conducted by the European Union
Article 23 – To the extent necessary to ensure uniform application of Directive Number 96/23/EC and in cooperation with the competent authority, the veterinary experts of the European Commission may verify on site that the plans and the implementation of these plans as well as the system for controlling them are in place.
The competent authority shall provide the experts all necessary facilities enabling them to carry out their duties.
The competent authority takes the necessary measures taking into account the results of the control and notifies the European Commission of the measures taken.
CHAPTER THREE
Measures to be taken in the event of infringement
Detection of unauthorized substances
Article 24 – Where unauthorized substances or products or substances listed in Group A and Group B (1) and (2) of Annex I are discovered in the possession of non-authorized persons, those unauthorized substances or products must be placed under official control until appropriate measures are taken by the competent authority, without prejudice to the possible imposition of penalties on the offenders.
Detection of illegal treatment
Article 25 – In the case of detection of illegal treatment, the competent authority shall do the following.
During the period in which animals are impounded as provided for in Article 19, animals from the farm in question may not leave the farm of origin or be handed over to any other person except under official control. The competent authority shall take preventive measures according to the nature of the substance or substances identified.
After sampling has been carried out in accordance with Article 19, if illegal treatment is detected, the animals found to be positive shall be slaughtered on the spot or taken to the designated slaughterhouse, accompanied by a veterinary certificate, to be slaughtered there. The slaughtered animals are sent to a high-risk processing plant.
In addition to these steps, samples must be taken at the expense of the farm’s owner from the entire batch of animals belonging to the farm at which controls were carried out and which may be suspect.
However, if half or more of the samples taken by representative sampling in accordance with Article 19 are positive, the farmer is left to make a choice between a control on all the animals present on the farm, which may be suspect or slaughter of these animals.
For a further period of at least 12 months or more, the farm/farms belonging to the same owner shall be subject to more stringent controls for the residues in question. Where an organized system of self-monitoring has been set up, this period may be reduced.
According to the state of the infringement detected, farms or establishments supplying the holding concerned shall be subject to controls in addition to those provided for in paragraph (a) of Article 13 to determine the origin of the substance in question. The same shall apply to all farms and establishments in the same supply chain of animals and animal feed as the farm of origin or departure.
Controls to be carried out at slaughterhouses and measures to be taken
Article 26 – The official veterinarian of a slaughterhouse must:
If he suspects or finds evidence that the animals concerned have been subjected to illegal treatment or that unauthorized substances or products have been administered to them:
Arrange for the animals to be slaughtered separately from other batches of animals arriving at the slaughterhouse.
Impound the carcasses and offal and carry out all sampling procedures necessary to detect the substances in question.
If positive results are obtained, without indemnity or compensation, send the meat and offal to a high-risk processing plant. In this case, Articles 22 and 25 shall apply.
If he suspects or has evidence that the animals concerned have been subjected to an authorized treatment but that the withdrawal periods have not been complied with, postpone slaughter of the animal until he is sure that the quantity of residue does not exceed the permitted level. This period may under no circumstances be less than the withdrawal period determined by the Ministry for the substances in question.
However, in a state of emergency or where the health status of animals requires so, or if the infrastructure or equipment of the slaughterhouse is not appropriate for postponing the slaughter, the animals may be slaughtered before the end of the said period. The meat and offal shall be impounded pending the outcome of the official controls carried out by the slaughterhouse’s official veterinarian. Only meat and offal containing a quantity of residues not exceeding the permitted levels shall be offered to human consumption.
Declare carcasses and products in which the residue level exceeds the levels permitted by legislation as unfit for human consumption.
Suspension or cancellation of authorization or approval of holdings
Article 27 – Without prejudice to criminal penalties, where the holding, use or manufacture of unauthorized substances or products in a manufacturing establishment is confirmed, any authorizations or official approvals granted to the establishment in question shall be suspended for a period during which the establishment shall be subjected to more stringent controls.
In the case of repeated behavior contrary to the legislation, such authorizations or approvals shall be cancelled.
Application of penalties
Article 28 – Without prejudice to criminal penalties or penalties imposed by professional bodies, appropriate administrative measures must be taken against any person where he is responsible for the transfer or administering of prohibited substances or products or for the administering of authorized substances or products for purposes other than those laid down in the current laws.
Action in case of obstructions
Article 29 – Any failure to cooperate with the competent authority and any obstruction by slaughterhouse personnel or the slaughterhouse supervisor or in the case of a private enterprise, by the slaughterhouse owner or owners, or by the owner of the animals or person in charge of them, during inspection and sampling as required for the implementation of the national residue-monitoring plan and during the investigations and controls conducted according to the provisions of this Regulation, shall result in appropriate criminal and/or administrative penalties being imposed by the competent authority.
CHAPTER FOUR
Imports
Submitting information for imports
Article 30 – The Ministry informs the importers regarding the countries they may import animals and animal products covered by this Regulation.
The Ministry, each year, makes a report of the results obtained from the residue controls conducted on imported animals and animal products.
Border inspections
Article 31 – Where border inspections reveal the use of unauthorized substances or products for the treatment of the animals in a given flock, or the presence of such substances or products in all or part of a batch originating from the same establishment, the competent authority shall take the following measures regarding these animals or products:
It shall inform the competent authority of the country of origin of the batch concerned and the products used.
It shall conduct more stringent controls on all batches of animals and products coming from the same origin. In particular, the next 10 batches from the same source must be impounded – and a deposit lodged against inspection costs – at the border inspection post for a control on residues by taking a representative sample of each batch.
Where such additional controls demonstrate the presence of unauthorized substances or products or of residues of such substances or products:
The batch or the part of the batch concerned must be returned to the country of origin at the expense of the consignor or his agent with a clear indication on the certificate of the reasons for rejecting the batch.
Depending on the nature of the infringement found and the risk associated with such an infringement, it must be left to the consignor to decide, without any compensation, whether to send back the batch or part of the batch concerned, to destroy it or to use it for other purposes laid down in legislation.
Where the controls at the border inspection post of imported animal products reveal that maximum residue limits have been exceeded, the controls referred to in sub-paragraph (b) of paragraph 1 are carried out.
The Ministry shall inform the competent authority of the country concerned on the results of the control.
CHAPTER FIVE
Penal procedures
Penal procedures to be applied in case of infringement
Article 32 – In the case of infringement of this Regulation, penal procedures shall apply according to Law No. 3285 on Animal Health and Surveillance, Law on the Adoption of the Amendment to the Law No. 5179 on the Production, Consumption and Inspection of Food, Law No. 1380 on Fishery Products, Law No. 1734 on Animal Feed and Law No. 1262 on Pharmaceuticals and Medicinal Products.
CHAPTER SIX
Final Provisions
Provisional Article 1 – Rules regarding animals slaughtered according to paragraph (b) of Article 25 and the high-risk processing plant to which meat and offal identified as positive as a result of the examination conducted according to paragraph (a) of Article 26 shall be sent to are re-established.
Enforcement
Article 33 – This Regulation enters into force on the date of its publication.
Execution
Article 34 – The provisions of this Regulation are executed by the Minister of Agriculture and Rural Affairs.
ANNEX I
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)“Pharmacologically active ingredients, the maximum level of which cannot be detected and that may not be found in foods at any level”.
GROUP B – Veterinary drugs(1) and contaminants
(1)Antibacterial substances, including sulphonomides, quinolones,
(2)Other veterinary drugs
(a)Anthelmintics
(b)Anticoccidials, including nitroimidazoles
(c)Carbamates and pyrethroids
(d)Sedatives
(e)Non-steroidal anti-inflammatory drugs
(f)Other pharmacologically active substances
(3)Other substances and environmental contaminants
(a)Organochlorine compounds including PcBs
(b)Organophosphorus compounds
(c)Chemical elements
(d)Mycotoxins
(e)Dyes
(f)Others
(1)Including unlicensed substances that could be used for veterinary purposes.
ANNEX II
Substance groups for Type of Animal, Feedstuff or Animal Product |
Bovine, sheep / goats, Porcine, equine animals |
Poultry |
Aquaculture animals |
Milk |
Eggs |
Rabbit meat, wild game animals and farmed game animals |
Honey |
A 1 |
X |
X |
X |
|
|
x |
|
2 |
X |
X |
|
|
|
x |
|
3 |
X |
X |
X |
|
|
x |
|
4 |
X |
X |
|
|
|
x |
|
5 |
X |
X |
|
|
|
x |
|
6 |
X |
X |
X |
X |
X |
X |
|
B 1 |
X |
X |
X |
X |
X |
X |
X |
2a |
X |
X |
X |
X |
|
x |
|
b |
X |
X |
|
|
x |
x |
|
c |
X |
X |
|
|
|
x |
x |
d |
X |
|
|
|
|
|
|
e |
X |
X |
|
x |
|
x |
|
f |
|
|
|
|
|
|
|
3a |
X |
X |
X |
x |
x |
x |
x |
b |
X |
|
|
x |
|
|
x |
c |
X |
X |
X |
X |
|
x |
x |
d |
X |
X |
X |
X |
|
|
|
e |
|
|
X |
|
|
|
|
f |
|
|
|
|
|
|
|
ANNEX III
SAMPLING STRATEGY
1) The residue control plan is aimed at surveying and revealing the reasons for residue hazards in primary animal products on farms, slaughterhouses, dairies, fish processing plants, and egg collecting and packing stations.
Official samples are to be taken in accordance with Annex IV.
Wherever official samples are taken, sampling must be unforeseen, unexpected and effected at no fixed time and on no particular day of the week. The competent authority must take all necessary measures to ensure that the element of surprise in the controls is constantly maintained.
2) For Group A substances, monitoring should be aimed at detecting the illegal administration of authorized substances and the administration of prohibited substances. The efficiency of this kind of sampling shall be intensified according to the relevant chapter of Annex IV.
The samples must be specified by taking into account sex, age, species, fattening system, all background information as well as all the evidence of misuse or abuse of substances in this group. The Ministry shall lay down details of these criteria separately.
3) For Group B substances, monitoring should be aimed particularly at controlling the compliance with MRLs for residues of veterinary medicinal products and pesticides laid down in relevant legislation, as well as monitoring the presence of environmental contaminants.
ANNEX IV
SAMPLING LEVELS AND FREQUENCY
The purpose of this Annex is to define the minimum number of animals from which samples are to be taken. Each sample can be analyzed for detecting the presence of one or more than one substance.
CHAPTER 1
Bovine, porcine, ovine, caprine and equine animals
1) Bovine animals
The minimum number of animals to be controlled each year for all kinds of residues and substances must at least equal 0,4% of bovine animals slaughtered the previous year.
The breakdown of the samples into groups should be as follows.
Annex I Group A: 0,25% divided as follows:
- Half of the samples shall be taken from live animals on the holding. 25% of the samples to be taken for the research of Group A(5) substances may be taken from feedstuff, drinking water etc.
- Half of the samples shall be taken from the slaughterhouse.
Each sub-group in Annex I Group A, must be controlled each year using a minimum of 5% of the total number of samples to be collected for Group A.
The balance in the breakdown of the samples must be allocated according to the results obtained in previous years and experience of the competent authority.
Annex I Group B: 0,15%
30% of the samples must be checked for Group B(1) substances.
30% of the samples must be checked for Group B(2) substances.
10% of the samples must be checked for Group B(3) substances.
The balance must be allocated according to the situation of the country.
2) Sheep and goats
The minimum number of animals to be controlled for all kinds of residues and substances must at least equal 0,05% of sheep and goats over three months of age slaughtered the previous year.
The breakdown of the samples into groups should be as follows.
Annex I Group A: 0,01%, this number must not be less than 20 animals.
Each sub-group of Group A must be checked each year using a minimum of 5% of the total number of samples to be collected for Group A.
The balance in the breakdown of the samples must be allocated according to the results obtained in previous years and experience of the competent authority.
Annex I Group B: 0,04%, this number must not be less than 80 animals.
The same breakdown per each sub-group for bovine animals has to be respected. The balance must be allocated according to the situation of the country.
3) Porcine animals
The minimum number of animals to be checked each year for all kinds of substances and residues must at least be equal to 0,05% of the pigs slaughtered the previous year. The breakdown of the samples into groups should be as follows.
Annex I Group A: 0,02%
Where sampling is being made at the slaughterhouse, drinking water, feedstuff, excrement or all other appropriate samples must be taken at the farm. In that case, the minimum number of farms to be visited annually must represent at least one farm per 100 000 pigs slaughtered the previous year, this number must not be less than ten farms.
Each sub-group in Group A must be checked each year using a minimum of 5% of the total number of samples to be collected for Group A.
The balance in the breakdown of the samples must be allocated according to the results obtained in previous years and experience of the competent authority.
Annex I Group B: 0,03%, this number must not be less than 60 pigs.
The breakdown per sub-group made for bovine animals must be taken into account. The balance must be allocated according to the situation of the country.
4) Equine animals
The number of samples is to be determined by the competent authority in relation to the problems identified.
CHAPTER 2
Broiler chickens, spent hens, turkeys and other poultry
Depending on the analytical method used, samples consist of one or more animals.
For each poultry species the minimum number of samples taken each year must at least equal one sample per 200 tons of annual meat production.
If the annual production of the species concerned exceeds 5000 tons, a minimum of 100 samples for each group of substances shall be taken.
The breakdown of the samples into groups should be as follows.
Annex I Group A: 50% of the total samples
One fifth of these samples must be taken at the farm.
Each sub-group of Group A must be checked each year using a minimum of 5% of the total number of samples collected for Group A.
The balance in the breakdown of the samples must be allocated according to the results obtained in previous years and experience of the competent authority.
Annex I Group B: 50% of the total samples,
30% of the samples must be checked for Group B(1) substances,
30% of the samples must be checked for Group B(2) substances,
10% of the samples must be checked for Group B(3) substances,
The balance must be allocated according to the situation of the country.
CHAPTER 3
Milk
1) Cow milk
A – Sampling requirements:
- Official samples must always be taken so as to provide traceability to the farm of origin where the samples milk was obtained from.
- The samples shall be taken from the places stated below:
a) Collecting tanks in milk farms,
b) Before the tanks in milk facilities have been emptied out.
- The monitoring principles specified above are not constantly applied in order to find the farm of origin for substances or residues stated in Annex I Group B3 (a), (b) and (c).
- Samples must be taken only from raw milk.
The number of samples shall depend on the analytical method used.
B – Sampling level and frequency:
The number of samples, which must not be less than 300 units, each year is determined by taking one sample per 15 000 tons of the annual milk production.
The breakdown laid down below shall be complied with:
- 70% of the samples shall be examined for the residues of veterinary medicines. In this case, each sample shall be tested for at least four different compounds and at least three groups from among groups A(6), B(1), B(2/a), and B(2/e) specified in Annex I .
- 15% of the samples shall be tested for the residues given in group B(3) of Annex I.
- 15% of the samples shall be tested depending on national facts.
2) Milk of other species such as sheep, goat, buffalo
The number of samples for these milks is determined according to the quantity produced and the problems identified. The samples to be taken from the said milks shall be included in the sampling plan as additional samples to cow milk samples.
- 50% of the total number of samples shall be tested for substances stated in group B1 and B2 of Annex I.
- 40% of the total number of samples shall be tested for substances stated in group B3(a) and (c).
10% of the total number of samples shall be tested depending on national facts.
CHAPTER 4
Honey
A – Sampling requirements:
The number of samples shall depend on the analytical method used.
The samples must be taken so as to provide traceability back to the original producer from any point in the production chain.
B – Sampling level and frequency:
The number of samples shall be at least 10 samples per 3000 tons of national production, and in addition to this number, one sample per 300 tons of production.
CHAPTER 5
Aquaculture products
1) Finfish farming products
A sample consists of one or more fish depending on the requirements of the analytical method and the size of the fish in question.
The competent authority must take into account the minimum sampling level and frequency given below, depending on the quantity of fish produced on the farm (in tons).
The minimum number of samples to be collected each year must be at least 1 per 100 tons of annual production.
The compounds sought and the samples selected for analysis should be selected according to the likely use of these substances.
The following breakdown must be respected:
Annex I Group A: one third of the total samples:
All the samples must be taken on the farm, on fish at all stages of farming, including fish which is ready to be placed on the market for consumption. (1)
Annex I Group B: two thirds of total samples:
Sampling should be carried out as stated below.
Preferably at the farm, on fish ready to be placed on the market for consumption,
At the processing plant or wholesale level, in the event of positive results, on fresh fish provided that traceability to the farm of origin is enabled.
In all cases, samples taken at farm level should be taken from at least 10% of registered sites of production.
2) Other aquaculture products
Where the competent authority has reason to believe that veterinary medicine or chemicals are being applied to other aquaculture products, or where it suspect environmental contamination, then these species must be included in the sampling plan in proportion to their production as additional samples to those taken from finfish farming products.
(1) For sea-farming, where sampling conditions are particularly difficult, samples may be taken from feed instead of from fish.