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Animal Owners ' Use Of Medicines For Animals As Well As Official Controls And Food Companies ' Own Checks With Residues

Original Language Title: Bekendtgørelse om dyreejeres anvendelse af lægemidler til dyr samt offentlig kontrol og fødevarevirksomheders egenkontrol med restkoncentrationer

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Table of Contents
Chapter 1 Scope and definitions
Chapter 2 Storage and labelling of medicinal products for animals
Chapter 3 Submission of medicinal products for animals
Chapter 4 Use of medicinal products and so on to animals
Chapter 5 The records and documentation of the crew responsible
Chapter 6 Revenue and Retention times
Chapter 7 Products of treated animals
Chapter 8 Inspection
Chapter 9 Penalty and entry into force

Publication of the use of medicinal products for animals for animals and the self-control of food-establishments and the self-determination of food business operators 1)

Purline Section 47, paragraph. Paragraph 1, section 48, paragraph. 1, § 50-52, § 53 (3). Paragraph 1, section 56, paragraph. 2, 3 and 5, § 61, § 66 a, paragraph. One and two, section 67 and section 70 (4). 3, in the law on animals of animals, cf. Law Order no. 466 of 15. In May 2014, the order shall be determined according to the order of the Commission. 558 of 28. May 2014 on the duties and powers of the Food Board :

Chapter 1

Scope and definitions

§ 1. The announcement concerns the use and storage of medicinal products for animals to be used for animals. The notice also provides for the illegal treatment and residues in products of animal origin, control and the self-control of food business operators in products of animal origin.

§ 2. For the purposes of this notice :

1) Crew : One or a collection of food-producing animals or fur animals of the same animal species used for a particular purpose linked to a particular geographical location and which has an owner in the form of a legal or physical person. By means of a herd, the same species or the herd of the same species recorded on a CHR number is defined as a herd.

2) Animals that are in human care.

3) Animal owner : anyone who has animals in their care.

4) Food-producing animals : bovine animals, swine, sheep, goats, animals of the herder (hereafter referred to as horses), excluding horses excluded from human consumption, cf. section 20, farmed deer and farmed birds, ostries, rabbits, poultry, including pigeons, aquaculture animals, honey bees and other animals whose meat or products are intended for human consumption.

5) Raw animals raised in accordance with the proverb of foxes and mink, ferret (ferret), matron, nutria, chinchilla and other animals to be raised in agricultural terms with a view to the exploitation of the fur.

6) Manufacturing animals : food-producing animals and fur animals.

7) Food business operators : food-producing animals and establishments receiving animals or products from herds of food-producing animals.

8) ' medicinal product ' means an item being presented as a suitable means for the treatment or prevention of animal diseases, or which may be used in or administered to animals, either in order to restore, alter or influence physiological functions by carrying out one ; pharmacologically, immunological or metabolic effect, or in order to provide a medical diagnosis.

9) Ordination period : The number of days in which the crew responsible for the crew must keep medicine.

10) Processing Period : The exact number of days within the period of the period during which the animals are treated for the diagnosed disease.

11) Statement : One of the veterinarian issued a unique written instruction for the use of the medicinal product in relation to a statement diagnosis.

12) Disease diagnosis : Diagnosis of a disease that occurs on a regular basis in the crew and characterized by the symptoms described by the veterinarian.

13) Illegal treatment : the use of non-authorised substances and the use of medicinal products for other purposes or in conditions other than those laid down in accordance with the applicable rules.

14) Not permitted substances : substances whose introduction into animals is prohibited in accordance with applicable rules.

15) Maximum residue limit (MRLs) : the maximum residue concentration of a pharmacological active substance (expressed as mg / kg or micrograms of wet weight) which may be permitted in animal food, cf. Article 1 (1). The provisions of paragraph 1 (a) of Regulation (EC) No (EC) No (EC) 470/2009 of 6. May 2009 laying down Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2 ; Council Regulation (EC) No 2377/90 and amending Parliament and Council Directive 2001 /82/EC and of the European Parliament and of the Council. 726/2004.

16) Residues : residues of substances with pharmacological effects and their transformation products and other substances transmitted to animal products and which may harm human health.

17) Application : The written records of the veterinarian :

a) the name and approval number of the veterinarian,

b) the name and address of the crew responsible ;

c) the CHR number in which the animals are located ;

d) the and the number of animals treated / treated (unique identification or, if this is not possible, number, estimated weight and subdivision or equivalent division),

(e) the prescribed medicinal products and the amount of medicinal products used, provided or prescribed,

(f) date of use, extradition or coordination ;

g) the exact indication of the dosage, administration and processing period of the medicinal products,

(h) the diagnosis made, and

i) they announced the withdrawal times.

Chapter 2

Storage and labelling of medicinal products for animals

§ 3. The animal owner may only store prescription-only medicinal products acquired by the animal by veterinarian, pharmacies or other operations approved by the Health Care Board for the negotiation of medicinal products.

Paragraph 2. Medicinal products for animals must be kept under clean and decent conditions and inaccessible to them.

§ 4. The person responsible for the crew must retain only prescription medicinal products for production animals for which the veterinarian has issued a written instructions.

Paragraph 2. For medicinal products prescribed by the veterinarian on the basis of a telephone consultation, the instruction from the last consultative visit shall apply.

Paragraph 3. In the milk-bearing herds of convalestion2 and with at least 50 cows to which the veterinarian prescribed medicinal products on the basis of a telephone consultation, the instruction from the last consulting time / operator visits shall apply.

§ 5. The person responsible for the crew must retain only prescription medicinal products for production animals within the period of the prescribed period, unless the medicinal products are represcribed before the end of the ordinal period.

Paragraph 2. Receptionable medicinal products for production animals must be kept on the CHR number to which they are provided or prescribed, cf. however, paragraph 1 3.

Paragraph 3. In bovine herds that are granted a derogation for the same operation, cf. Whereas the publication of the marking, registration and movement of bovine animals, pigs, sheep or goats, and for which a single health advisory agreement has been concluded, prescription-only medicines must be kept on the CHR number in which the animals are located.

§ 6. The animal owner may only keep prescription-only medicinal products which, by veterinary medicine, pharmacies or other operations approved by the Health Care Board for the negotiation of medicinal products, are provided with a label.

Paragraph 2. If the label of a medicinal product is placed on an outer packaging, the medicinal product and the outer wrappings must be stored together. The label shall not be destroyed or removed.

Chapter 3

Submission of medicinal products for animals

§ 7. The person responsible for the crew may only submit medicinal products to its production animals if the person concerned has undergone a course in the use of medicinal products approved by the Food and FSA, and may substantiate this.

Paragraph 2. Except for the requirement set out in paragraph 1. 1 on the participation of the courier shall be the crew responsible for each ; 1. February 2007 :

1) have more than six months of cohesive practical experience of the production of animals, including the submission of medicinal products to animals, and

2) have obtained it in paragraph 1. Paragraph 1 mentioned the experience of full-time employment in a herd.

Paragraph 3. In addition, people who treat horses who live in zoos, animal parks and the like are excluded from the call for Kurdish attendance, cf. paragraph 1.

Paragraph 4. The Food Authority may invite the crew responsible for taking part in the course referred to in paragraph 1. 1 if the Agency for Control activities considers that the crew responsible does not comply with the requirements for the submission of medicinal products to animals. The Food Authority may also offer a crew responsible for the persons referred to in section 9 (4). 1, participate in a course.

Paragraph 5. The Food Authority may, on application, grant a derogation from the requirement referred to in paragraph 1 1, above all, if the applicant may prove to have the acquired qualifications otherwise than mentioned in paragraph 1. One and two.

§ 8. Injection under the skin (subcutaneous) and injection of the musculature (intramucous) must be carried out as closely as possible to the ears of sheep and goats in the middle of the neck, in the middle of the neck, or in the middle of the bow and on the horses in the middle of the neck or in the middle of the neck or the neck. The bringen. In pigs, vaccination by means of particular equipment which does not involve the use of needles shall also be carried out at the carrot. Injections under the skin of iron and vitamin preparations may be carried out in the light-keepers of piglets.

Paragraph 2. The crew responsible shall not inject blood vessels in the arghul in the abdomen, in the seals and the spinal cord or the spinal cord or affixed medicinal products in the uterus (stock market), cf. however, paragraph 1 3 and 4.

Paragraph 3. Exempted from paragraph 1. 2 are crew responsible who have received authority from the Food Authority to treat cows suffering from sleepovers and / or withheld bacterial infection if a stock diagnosis is available for the disease in question.

Paragraph 4. A crew responsible for a herd of aquaculture animals may, upon arrival of a veterinarian, carry out the inoculation of fish at injections in the bughul.

§ 9. The crew responsible must allow other persons to submit medicinal products to their production animals only if the persons concerned are concerned ;

1) is more than 18 years old,

2) meet the conditions laid down in section 7 (3). 1 and 2, and

3) have been made aware of the content of the veterinarian's instructions.

Paragraph 2. The crew responsible must allow other workers to treat cows suffering from sleepovers and / or withheld bacterial infection if the authority concerned has received authorization from the Food Authority.

Paragraph 3. The Food Authority may, on application, grant a derogation from the requirement referred to in paragraph 1 1, above all, if the applicant may prove to have the acquired qualifications otherwise than mentioned in paragraph 1. 1, no. 2.

Chapter 4

Use of medicinal products and so on to animals

§ 10. The animal owner may only use medicinal products for the treatment of animals whose storage is permitted under section 3 to 6.

§ 11. Receptionable medicinal products shall be used in accordance with the veterinarian's instructions.

Paragraph 2. In bovine herds, for which an agreement on health advice is concluded with the addition of 2, the responsible person shall use the medicinal products in accordance with the veterinarian's transcript for the marketing diagnoses.

§ 12. When the veterinarian is supplying or prescribing other antibiotics other than simple penicillin treatment for infections in bovine herds, for which an agreement on health advice is concluded with the option 2, the person responsible for the herd must take the responsibility of the herd ; the milk sample for bacteriological examination and resistant examination before treatment is opened. The milk sample must be analysed by the veterinary surgeon or a laboratory with an accredited method.

§ 13. In the case of delivery or prescribing of prescription-only medicinal products for production animals, the person responsible for the veterinarian must sign the veterinarian ' s instructions at the visit of the veterinarian.

§ 14. The crew responsible shall store the instructions given by the veterinarian in the crew for at least five years after the date of the visit of the veterinarian. The instructions must be stored in the date order and required for or be handed over to the inspection authority.

Chapter 5

The records and documentation of the crew responsible

§ 15. When the undertaking responsible uses prescription-only medicines, this means that the inline of the processing equipment must perform legible records :

1) Date of the initiation and completion of the treatment.

2) The and the number of animals processed (unique identification or, if this is not possible, quantity, estimated weight, or the number or the corresponding split (s).

3) Reason for processing.

4) What medicinal product has been used.

5) Dosage of the medicinal product (used quantity per year. the charge and number of operations per capbe ; today) and how this has been submitted.

Paragraph 2. The records shall be kept in the crew, cf. however, paragraph 1 3, no. 1, for at least five years after the initiation of the treatment. The records shall be kept together, transparent and in the date order and shall be presented to the inspection authority or be presented to the inspection authority as required.

Paragraph 3. In bovine herds that are granted a derogation for the same operation, cf. the notification of the marking, registration and movement of bovine animals, swine, sheep or goats, and for which a single health advisory agreement has been concluded and in bovine herds where agreement on health advice has been concluded with the option 2, and where : The period of coordination shall be fulfilled until nine months :

1) The people in paragraph 3. 1 mentioned records shall be carried out by electronic transmission to Animal registration during the opening of the treatment.

2) The crew responsible has announced to the Agriculture and Scientific Centre for Agriculture, Cattle, that the use of medicinal products is registered in Animal Registration.

3) The crew responsible has notified the Scientific Centre for Agriculture, the Bovine that the reported information shall be available to the crew veterinarian and for the inspection authority for at least five years.

Paragraph 4. Requirement of records, cf. paragraph However, 1 shall not apply to sera, vaccines and V-labelled irons and vitamin preparations.

Chapter 6

Revenue and Retention times

§ 16. Any person who markets, sells or overdragons food-producing animals is required to supply only animals or products from animals :

1) which has not been administered by the substance of the substance,

2) which has not been subject to illegal treatment, and

3) in respect of which the retention time has been complied with.

Paragraph 2. Food-producing animals containing residues of a permitted medicinal product which exceeds the maximum levels fixed may not be delivered to slaughter or to the market for slaughter animals.

Paragraph 3. Food-producing animals which are subject to a detention period must not be forced to have to be slaughtered.

Paragraph 4. Notwithstanding paragraph 1 1 may be transferred by the race, competition or circulation and horses intended for breeding or exhibition, before the end of the withdrawal period, if the animal is accompanied by a veterinary certificate, the nature and date of which the treatment is apparent.

§ 17. Food-producing animals which have been administered not-authorised substances listed in Annexes II and III to Council Directive 96 /22/EC of 29. April 1996 banning the use of certain substances having a hormonal and thyrostatic action and of beta-agonists in livestock farming and repealing Directives 81 / 6 0 2 / EEC, 88 /146/EEC and 88 /299/EEC shall not have a stay in a herd unless the animals are below ; official controls, and the animals must not be placed on the market, sold or transferred to others.

Paragraph 2. Exempted from paragraph 1. However, 1, however, is food-producing animals treated with the substances referred to in paragraph 1. 1, under the veterinarian's direct personal responsibility, and in accordance with Community legislation.

Paragraph 3. Aquaculture animals treated with the androgenic effects of medicinal products for the purposes of gender conversion shall not be sold for human consumption. After authorisation from the Food Authority, animals may be moved or negotiated with a view to the taking of semen elsewhere.

Chapter 7

Products of treated animals

§ 18. Products derived from food-producing animals, including meat, milk, eggs, fish and honey, may not be marketed, sold, transferred, processed or used for human consumption if they contain residues of a permitted medicinal product for animals ; the maximum residue limit or if they contain residues of substances originating from unlawful treatment.

§ 19. Products derived from food-producing animals which have been treated in breach of section 16 (3). 1, no. The placing on the market of 1 shall not be marketed, sold, transferred or processed for human consumption.

20. Horses that are treated with medicinal products that exclude the animal from human consumption may not be delivered to slaughter.

Paragraph 2. The animal owner shall, in accordance with ' Animal and Equity ' s certificate of equidae treated with medicinal products excluding the animal from human consumption ', leave the declaration following the horse of any relocation and inform the new owner that the horse must not be allowed to : be used for human consumption unless the horse is accompanied by a passport containing Title IX and where the exclusion of the horse from human consumption is contained, cf. Article 5 of Commission Regulation (EC) No, 504/2008 of 6. June 2008 on the implementation of Council Directive 90 /426/EEC and 90 /427/EEC in respect of methods for the identification of equidae.

Paragraph 3. In the death of the animal, it must be destroyed on one of the Food Authority ' s processing plant for Category 1 material or disposed of in a second legal manner.

Chapter 8

Inspection

Check-check

§ 21. Food business operators, seller or processed products of animal origin shall carry out any self-control that ensures that only :

1) animals by direct delivery or via intermedimand, for which the producer can guarantee that the retention time is complied with ;

2) animals or products which conform to the maximum residue limits ; and

3) animals or products without any content of prohibited substances or of products derived thermals.

Paragraph 2. Food business operators must also ensure that products derived from animals that satisfy the requirements of paragraph 1 are placed on the market only. 1, no. 1-3.

Paragraph 3. Food business operators shall notify the Food Authority by exceeding the permitted limit values for residues and for the content of prohibited substances or of the conversion products thereof.

Official controls on illegal treatment

§ 22. If the analysis of a publicly tested test shows a positive result, the Food Authority may perform the following :

1) The check of the herd of origin or the herd from which the animal or product originate in order to determine the cause of the presence of residues.

2) A study on the source or source of the residues concerned.

3) All other studies that are deemed necessary.

-23. In case of suspicion of illegal treatment, the Food Board shall carry out a study of the crew responsible and / or the veterinarian's documentation for processing.

Paragraph 2. Where the documentation referred to in paragraph 1 is referred to in paragraph 1. 1, contests the suspected or corrodication of the unauthorized treatment or submission of non-authorised substances, shall carry out checks on the FDA, which may include :

1) Samples control of the animals in the herd of origin or the herd from which the animals come from, to determine the illicit treatment or use of non-authorised substances, including whether implantation has been carried out.

2) Controls to establish whether or not to store non-authorised substances in the herd of origin, the herd from which animals come from or herds belonging to the same owner and where animals are reared, kept or fattened.

3) Samples of feed and potable water in the herd of origin or the herd from which animals come from or for the aquatic species of the water in which they are residing.

4) Any checks necessary to clarify the origin of non-authorised substances, and of the animals treated.

§ 24. The animals from which samples are taken, cf. section 22-23, must be uniquely identified and must not leave the crew until the results of the tests are available.

§ 25. If, based on the tests referred to in Section 22-23, the herd must be subject to official controls, the crew shall be subject to official controls which cause all animals to be supplied with a mark or an official identification and must not leave the herd ; unless it is subject to official controls.

Paragraph 2. The Food Management Board shall ensure that further tests are taken on a statistical representative basis based on internationally recognised scientific information.

SECTION 26. If the results of the tests that are taken pursuant to section 25 (2) shall be taken into account. 2, demonstrating illegal treatment, the animals for which the results are positive must be carried out.

Paragraph 2. The derived animals must be sent to the destruction of a processing plant in respect of Category 1 material approved by the Food Authority.

§ 27. In addition, the FDA shall also take samples of the whole lot of animals belonging to the controlled crew and are suspected.

Paragraph 2. If half or more of the samples taken in accordance with section 25 (2) shall be taken. 2 is positive, the person responsible for the crew, regardless of the provision set out in paragraph 1. 1, however, to choose between the checks on all animals of the crew under suspicion or animation of the animals in question.

Paragraph 3. The FDA shall submit to other herds belonging to the crew responsible for the crew, increased control over a period of not less than 12 months.

Paragraph 4. The Food Management Board shall submit the necessary additional checks to identify the origin of non-authorised substances in order to identify the origin of the products concerned. The additional checks shall also include crews whose supplies of animals and feedingstuffs come from the same source as the herd of origin or the crew from which the animals come from.

Official controls on residues of authorized medicinal products in food-producing animals

§ 28. When detecting residues of a medicinal product of the maximum limit of a public sample taken from a food-producing animal or products thereof, the Food Management Board shall check the herd of origin or the herd which, the animals or products come from.

Paragraph 2. The Food Authority may take the necessary measures to ensure public health, including the prohibition of the removal of the animals from the crew or removing the products from the food business concerned in a specified period.

Paragraph 3. In the event that a food business is repeatedly exceeded the maximum residue levels in the marketing, sale or transfer of animals or products of animals, the Food and Food Management Board shall submit to the animals or products in it ; for a period of not less than 6 months in question, the food industry has increased control. During this period, animals or products from the food establishment shall be withheld until the results of the samples taken are available.

Paragraph 4. If the results of the tests carried out in accordance with paragraph 1 shall be taken. In the case of residues above the maximum fixed threshold, the animals or products concerned shall not be used for human consumption.

Official controls on slaughterhouses

§ 29. In the case of suspicion of unlawful treatment, there must be separate slaughter, the retention of all parts of the animal and the taking of necessary samples.

Paragraph 2. If the results of the tests carried out in accordance with paragraph 1 shall be taken. 1, detect illicit treatment using not permitted substances shall be sent to the destruction of all parts of the animal to the processing plant for category 1 material approved by the Food Authority.

Paragraph 3. If the results of the tests carried out in accordance with paragraph 1 shall be taken. 1, proof of unauthorized handling of substances, the Food Authority may take all necessary measures to ensure public health.

-$30. If an animal covered by a detention period is delivered for slaughter, the animal must not be slaughtered for human consumption before the expiry time has expired.

Paragraph 2. If the animal is slaughtered before the withdrawal period has expired, for example, in the case of animal welfare, or where the slaughterhouse has no infrastructure or equipment that makes it possible to defer the slaughter of the animal, all parts of the animal shall be sent to : destruction of a processing plant for Category 2 approved by the Food Authority.

§ 31. Where residues are shown in a slaughterhouse against maximum residue limits, all parts of the animal shall be sent to the destruction of a processing plant in respect of Category 2 approved by the Food Service.

§ 32. If the owner or person responsible for a slaughterhouse is proved to conceal the use of non-authorised substances, the person responsible shall be excluded from receiving and applying for Community aid for a 12-month period.

Cost

§ 33. Costs resulting from measures taken in connection with suspicion of illegal treatment or of non-compliance with the rules on the use of medicinal products for animals and which lead to the detection of unauthorised residues ; or not authorized, the owner of the animal.

Paragraph 2. The cost of the destruction of food-producing animals, which is to be treated with non-authorised or prohibited substances, is public inexcures.

Chapter 9

Penalty and entry into force

§ 34. With fine punishment, the one who :

1) is in violation of section 3, section 4 (4). 1, sections 5 and 6, section 7 (4). Paragraph 1, section 8, section 9, paragraph 9. 1 and 2, section 10-14, section 15, paragraph 1. One-three, paragraph 16, paragraph 16. 1-3, section 17, paragraph 17. 1 and 3, section 18-21, section 24, section 25 (4). Paragraph 1, section 26, section 28, paragraph 28. 4, section 29, paragraph. 1 and 2, and sections 30 and 31,

2) infringe Article 16 of Regulation (EC) No, 470/2009 on Community procedures for the establishment of limit values for residues of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2 ; Council Regulation (EC) No 2377/90 and amending Parliament and Council Directive 2001 /82/EC and of the European Parliament and of the Council. 726/2004,

3) omits to comply with the provisions and prohibitions issued in accordance with section 7 (2) ; 4, and section 28 (3). Article 29 (2) and Section 29 (2). 3, or

4) shall not comply with the conditions laid down in Article 7 (1). 5, section 9, paragraph. 3, or Section 17 (3). THREE, TWO. Act.

Paragraph 2. For the infringement of the provisions referred to in paragraph 1. The penalty shall be 1 in accordance with section 70 (3). 3, in the Act of Crew of Animals, for up to 2 years, if by the action or omission, the offence has been committed with a set of or gross negligence and there is a breach in the infringement proceedings ;

1) any injury to human or animal health or induced danger ; or

2) obtained or intended for the economic benefit of the person concerned itself or others, including in savings.

Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.

$35. The announcement shall enter into force on 1. January 2015.

Paragraph 2. At the same time, notice No 780 of 24. June 2010 on the use of medicinal products for the animal owners of animals and the self-control of food establishments.

The FDA, the 171. December 2014

P.V.V.
John Larsen

/ Mette Hulcurrent

Official notes

1) The announcement contains provisions which implement parts of Council Directive no. 96 /22/EEC of 29. April 1996 banning the use of certain substances having a hormonal and thyreostatic action and of beta-agonists in livestock farming and repealing Directive No 1. Article 81 /602/EEC, nr. Amendments Nos 88 /146/EEC and nr. OJ 88 /299/EEC, OJ 1996, L125, p. Three, as last amended by Directive 7 of the European Parliament and the Council. 2008 /97/EC of 19. This is November 2008, EUT 2008, L318, p. 9, Council Directive no. 96 /23/EC of 29. April 1996 on the control measures to be carried out for certain substances and residues thereof in live animals and their products and repealing Directive No 1 ; 85 /358/EEC and no. 86 /469/EEC and Decision no. 89 /187/EEC and nr. 91 /664/EEC, OJ 1996, L 125, p. Amendment No 10, as last amended by Council Directive no. 2013/20 of 13. May 2013, EUT 2013, L158, s. Directive 234, Parliament and the Council directive no. 2001 /82/EC of 6. November 2001 establishing a Community Code of Veterinary Medicinal Products, OJ 2001, L311, p. Regulation 1, as last amended by Regulation (EC) No 2 of the European Parliament and of the Council 596/2009 of 18. June 2009, EUT 2009, L188, p. 14.