
TITLE I
Article 1 

1. For the purposes of ensuring food safety, this Regulation lays down rules and procedures in order to establish:
(a) the maximum concentration of a residue of a pharmacologically active substance which may be permitted in food of animal origin (maximum residue limit);
(b) the level of a residue of a pharmacologically active substance established for control reasons in the case of certain substances for which a maximum residue limit has not been laid down in accordance with this Regulation (reference point for action).
2. This Regulation shall not apply:
(a) to active principles of biological origin intended to produce active or passive immunity or to diagnose a state of immunity, used in immunological veterinary medicinal products;
(b) to substances falling within the scope of Regulation (EEC) No 315/93.
3. This Regulation shall apply without prejudice to ... legislation prohibiting the use in food-producing animals of certain substances having a hormonal or thyrostatic action and of beta-agonists, as provided for by the  assimilated  law which transposed  Directive 96/22/EC.
Article 2 
In addition to the definitions laid down in Article 1 of Directive 2001/82/EC, Article 2 of Regulation (EC) No 882/2004 and Articles 2 and 3 of Regulation (EC) No 178/2002, the following definitions shall apply for the purposes of this Regulation:

((a)) ‘residues of pharmacologically active substances’ means all pharmacologically active substances, expressed in mg/kg or μg/kg on a fresh weight basis, whether active substances, excipients or degradation products, and their metabolites which remain in food obtained from animals;
((b)) ‘food-producing animals’ means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.
TITLE II
CHAPTER I
Section 1
Article 3 
This  Regulation applies to any pharmacologically active substance intended for use in  Great Britain  in veterinary medicinal products which are to be administered to food producing animals.
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Article 4 

1. Where an application for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product is made under Article 8, the  Secretary of State  must produce an assessment report which includes a scientific risk assessment and risk management recommendations for the purposes of establishing maximum residue limits for the substance in question.
2. The scientific risk assessment and the risk management recommendations shall aim to ensure a high level of human health protection, whilst also ensuring that human health, animal health and animal welfare are not negatively affected by the lack of availability of appropriate veterinary medicinal products.  The assessment report must take account of any relevant findings of internationally recognised scientific bodies.
Article 5 
 With a view to ensuring the availability of authorised veterinary medicinal products for conditions affecting food-producing animals whilst ensuring a high level of protection of human health, the  Secretary of State  must consider extrapolating maximum residue limits from one species to another or from one foodstuff to another when drafting risk management recommendations
Article 6 

1. The scientific risk assessment shall consider the metabolism and depletion of pharmacologically active substances in relevant animal species, the type of residues and the amount thereof, that may be ingested by human beings over a lifetime without an appreciable health risk ....
2. The scientific risk assessment shall concern the following:
(a) the type and amount of residue considered not to present a safety concern for human health;
(b) the risk of toxicological, pharmacological or microbiological effects in human beings;
(c) residues that occur in food of plant origin or that come from the environment.
3. If the metabolism and depletion of the substance cannot be assessed, the scientific risk assessment may take into account monitoring data or exposure data.
Article 7 
The risk management recommendations shall be based on the scientific risk assessment performed in accordance with Article 6 and shall consist of an assessment of the following:

((a)) the availability of alternative substances for the treatment of the relevant species or the necessity of the substance evaluated in order to avoid unnecessary suffering for animals or to ensure the safety of those treating them;
((b)) other legitimate factors, such as the technological aspects of food and feed production, the feasibility of controls, conditions of use and application of the substances in veterinary medicinal products, good practice in the use of veterinary medicinal and biocidal products and the likelihood of misuse or illegal use;
((c)) whether or not a maximum residue limit or a provisional maximum residue limit should be established for a pharmacologically active substance in veterinary medicinal products, the level of that maximum residue limit and, where appropriate, any conditions or restrictions for the use of the substance concerned;
((d)) whether the data provided are not sufficient to allow a safe limit to be identified, or whether a final conclusion concerning human health with regard to residues of a substance cannot be established given the lack of scientific information. In either case, no maximum residue limit may be recommended.
Article 8 

1. An application under these Regulations for a new or amended maximum residue limit for a substance intended for use in a veterinary medicinal product must be made to the Secretary of State.
2. An application must include all necessary administrative information, and all scientific documentation necessary for demonstrating the safety of the substance.
3. The applicant must pay to the  Secretary of State  the application fee, which is—
(a) for a new maximum residue limit in respect of a substance, £62,300;
(b) for an amended maximum residue limit in respect of a substance, £18,850.
4. The Secretary of State must ensure that where a valid application is received, the substance is classified under Article 14 within 210 days.
5. For the purposes of paragraph 4 an application is valid when both the requirements in paragraphs 2 and 3 have been complied with.
6. As soon as practicable after the substance is classified under Article 14, the Secretary of State must publish—
(a) a notice setting out the classification;
(b) the assessment report that has been prepared, with any commercially confidential or personal information deleted.
7. If the Secretary of State classifies a substance under Article 14(2)(b) or (d), the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee under regulation 29 of the Veterinary Medicines Regulations 2013.
Section 2
Article 9 

1. The  Secretary of State  may classify a substance intended for use in a veterinary medicinal product which is to be administered to food-producing animals under Article 14 without an application having been made under these Regulations.
2. The power in paragraph 1 includes power to classify a substance which has previously been classified under Article 14.
Article 10 

1. An application for the classification of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry pursuant to Article 19(7) of Regulation (EU) 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products must be made under Article 8, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals.
(1A.) The power to classify a substance under Article 9 may be exercised in respect of a pharmacologically active substance intended to be used in a biocidal product used in animal husbandry, notwithstanding that it is not a substance intended for use in a veterinary medicinal product to be administered to food-producing animals, where the Secretary of State considers it appropriate to do so for the purposes of Article 19(1)(e) of Regulation (EU) 528/2012.
(1B.) Where proposals are made for the classification of a substance under Article 9 in the circumstances described in paragraph 1A by a devolved authority, the Secretary of State must have regard to such proposals when exercising functions under that paragraph.
(1C.) In this Article, “devolved authority”  means the Scottish Ministers or the Welsh Ministers.
2. The   Secretary of State   shall classify the pharmacologically active substances referred to in  paragraphs 1 and 1A  in accordance with Article 14 , subject to the consent requirement in Article 83B of Regulation (EU) 528/2012 (treating this Article as a provision of that Regulation for the purposes of construing Article 83B(1)). ...However, any specific provisions relating to the conditions of use of the substances classified in accordance with the first subparagraph of this paragraph shall be laid down pursuant to  Article 19(7) of Regulation (EU) No 528/2012.
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Section 3
Article 11 
Where  the  Secretary of State  considers that a review of the maximum residue limit for a substance is necessary in order to protect human or public health and issues a notice to that effect to the Veterinary Products Committee, that Committee must review the substance in question and report its findings to the  Secretary of State, together with any recommendations.
Article 12 
 The Secretary of State  must publish the assessment report referred to in Article 4  after deleting any information of a commercially confidential nature.
Article 13 
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CHAPTER II
Article 14 

1. The  Secretary of State  must classify pharmacologically active substances in accordance with this Article.
2. The classification shall include a list of pharmacologically active substances and the therapeutic classes to which they belong. The classification shall also establish, in relation to each such substance, and, where appropriate, specific foodstuffs or species, one of the following:
(a) a maximum residue limit;
(b) a provisional maximum residue limit;
(c) the absence of the need to establish a maximum residue limit;
(d) a prohibition on the administration of a substance.
3. A maximum residue limit shall be laid down where it appears necessary for the protection of human health , and when laying down a limit regard may be had to any international decisions in respect of that substance.
4. A provisional maximum residue limit may be established in cases where scientific data are incomplete, provided that there are no grounds for supposing that residues of that substance at the level proposed constitute a hazard to human health.The provisional maximum residue limit shall apply for a defined period of time, which shall not exceed five years. That period may be extended once for a period not exceeding two years where it is demonstrated that such an extension would allow completion of scientific studies in progress.
5. No maximum residue limit shall be established where ... it is not necessary for the protection of human health.
6. The administration of a substance to food-producing animals shall be prohibited ... in either of the following circumstances:
(a) where any presence of a pharmacologically active substance or residues thereof in foods of animal origin may constitute a hazard to human health;
(b) where no final conclusion concerning the effect on human health of residues of a substance can be drawn.
7. Where it appears necessary for the protection of human health, the classification shall include conditions and restrictions for the use or application of a pharmacologically active substance used in veterinary medicinal products which is subject to a maximum residue limit, or for which no maximum residue limit has been set.
Article 14A 

(1. The  Secretary of State  must maintain a register (“the MRL register”) in accordance with this Article.
(2. The MRL register must contain—
(a) a list of substances which have been classified under Article 14;
(b) in respect of each such substance—
(i) any maximum residue limit or other matter established under paragraph 2 of Article 14;
(ii) any conditions or restrictions included in the classification pursuant to paragraph 7 of Article 14.
(3. The MRL register must be kept up to date.
(4. The MRL register must contain a search facility.
(5. The  Secretary of State  must make the MRL register available for inspection by the public on a website maintained by the Secretary of State.
Article 15 
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Article 16 

1. Only pharmacologically active substances which are classified in accordance with Article 14(2)(a), (b) or (c) may be administered to food-producing animals ....
2. Paragraph 1 does not apply in the case of clinical trials which are authorised under an Animal Test Certificate.
Article 17 
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TITLE III
Article 18 
When it is deemed necessary in order to ensure the functioning of controls of food of animal origin imported or placed on the market in accordance with Regulation (EC) No 882/2004, the  Secretary of State may establish reference points for action for residues from pharmacologically active substances which are not subject to a classification in accordance with Article 14(2)(a), (b) or (c).
The reference points for action shall be reviewed regularly in the light of new scientific data relating to food safety, the outcome of the investigations and analytical tests referred to in  relevant international decisions and technological progress.
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Article 19 

1. The reference point for action must be set having taken into account the lowest residue concentration which can be quantified with an analytical method validated in accordance with the Annex to Commission Decision 2002/657/EC. The relevant national reference laboratory must advise the appropriate authority on the performance of analytical methods.
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Article 20 
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TITLE IV
Article 21 
The   Secretary of State  must consult relevant national reference laboratories on appropriate analytical methods for detecting residues of pharmacologically active substances for which maximum residue limits have been determined in accordance with Article 14.
Article 22 
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Article 23 
Food of animal origin containing residues of a pharmacologically active substance:

((a)) classified in accordance with Article 14(2)(a), (b) or (c) at a level exceeding the maximum residue limit established pursuant to this Regulation; or
((b)) not classified in accordance with Article 14(2)(a), (b) or (c), except where a reference point for action has been set for that substance pursuant to this Regulation and the level of residues does not equal or exceed that reference point for action;
shall be considered not to comply with   assimilated law.
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Article 24 
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TITLE V
Article 25 
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Article 26 
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Article 27 
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Article 28 
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Article 29 
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References to the repealed Regulation shall be construed as references to this Regulation or, as appropriate, to the regulation referred to in Article 27(1) of this Regulation.
Article 30 
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Article 31 
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Article 32 
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...Done at Strasbourg, 6 May 2009.
For the European Parliament
The President
H.-G. PÖTTERING
For the Council
The President
J. KOHOUT