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Document 02019R2090-20221019
Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (Text with EEA relevance)Text with EEA relevance
Consolidated text: Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (Text with EEA relevance)Text with EEA relevance
Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (Text with EEA relevance)Text with EEA relevance
02019R2090 — EN — 19.10.2022 — 001.001
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COMMISSION DELEGATED REGULATION (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317 9.12.2019, p. 28) |
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COMMISSION DELEGATED REGULATION (EU) 2022/1667 of 19 July 2022 |
L 251 |
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29.9.2022 |
COMMISSION DELEGATED REGULATION (EU) 2019/2090
of 19 June 2019
supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances
(Text with EEA relevance)
Article 1
Subject matter
This Regulation lays down rules on specific requirements for official controls and applicable measures for cases of non-compliance or suspected non-compliance with Union rules applicable to the use of authorised, unauthorised or prohibited pharmacologically active substances on food-producing animals and to their residues.
Article 2
Definitions
For the purposes of this Regulation, the definitions in Regulation (EU) 2017/625, Directive 2001/82/EC and Regulation (EC) No 470/2009 shall apply. The following definitions shall also apply:
‘pharmacologically active substance’ means any substance or mixture of substances intended to be used in the manufacture of a veterinary medicinal product that, when used in its production, becomes an active ingredient of that product;
‘unauthorised substances’ means pharmacologically active substances, which are not included in Table 1 of the Annex to Regulation (EU) No 37/2010 or substances that are not authorised as a feed additive under Regulation (EC) No 1831/2003, with the exception of substances essential for the treatment of equidae and substances bringing added clinical benefit compared to other treatment options available for equidae, as laid down in Regulation (EC) No 1950/2006.
‘illegal treatment’ means the use in food producing animals of
For the purpose of this Regulation for substances or veterinary medicinal products authorised under Union legislation, non-compliance with the withdrawal period or residues of pharmacologically active substances exceeding the maximum residue limit or maximum level shall not be considered as an illegal treatment, provided that all other conditions on the use of the substance or veterinary medicinal product, laid down in Union or national legislation, are complied with.
‘residues of pharmacologically active substances exceeding the maximum residue limit’ means the presence of residues of authorised pharmacologically active substances in products of animal origin in a concentration, exceeding the maximum residue limits set under Union legislation;
‘residues of pharmacologically active substances exceeding the maximum level’ means the presence of residues of pharmacologically active substances in products of animal origin, resulting from the unavoidable carry-over of these substances in non-target feed, in a concentration, exceeding the maximum levels set under Union legislation;
‘batch of animals’ means 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.
Article 3
Actions to be taken at the slaughterhouse in case of non-compliance or suspected non-compliance
If the official veterinarian performing official controls in a slaughterhouse or the official auxiliary performing certain tasks in the framework of these controls suspect or has evidence that animals have been subject to illegal treatment, the official veterinarian shall ensure that the following actions are taken:
order that the operator keeps the concerned animals separated from other batches of animals present or arriving at the slaughterhouse under the conditions to be established by the competent authority;
arrange for the animals to be slaughtered separately from other batches of animals present at the slaughterhouse;
order that the operator separates the carcases, meat, offal and by-products from the concerned animals, to be immediately identified and kept separated from other products of animal origin, and order such products not to be moved, processed or disposed without prior authorisation by the competent authority;
order that samples necessary to detect the presence of prohibited or unauthorised substances or of authorised substances, in case of a suspected or established use under conditions other than those laid down in the legislation, are taken.
If the official veterinarian performing official controls in a slaughterhouse or the official auxiliary performing certain tasks in the framework of these controls suspects that the animals present in the slaughterhouse have been treated with an authorised veterinary medicinal product, but that the withdrawal period referred to in Directive 2001/82/EC has not been respected, the official veterinarian shall order that the concerned animals are separated from other batches of animals present or arriving at the slaughterhouse, under conditions to be established by the competent authority. The official veterinarian shall also:
The slaughter may only be postponed temporarily, provided that the official veterinarian has verified that the Union legislation on animal welfare is respected and that the concerned animals can be kept separated from the other animals.
When the slaughter is postponed in accordance with paragraph (3), the withdrawal period shall in no circumstances be shorter than:
Following the postponement of the slaughter, the competent authority may take samples at the expense of the operator to verify compliance with the maximum residue limits once the animals have been slaughtered after the expiry of the withdrawal period.
If the official veterinarian performing official controls in a slaughterhouse or the official auxiliary performing certain tasks in the framework of these controls has evidence that the animals present in the slaughterhouse have been treated with an authorised veterinary medicinal product, but that the withdrawal period referred to in Directive 2001/82/EC has not been respected, the official veterinarian shall order that the concerned animals are separated from other batches of animals present or arriving at the slaughterhouse, under conditions to be established by the competent authority. The official veterinarian shall also:
Article 4
Investigation
Where the maximum residue limits for pharmacologically active substances authorised in veterinary medicinal products or as feed additives, set on the basis of Regulation (EC) No 470/2009 and Regulation (EC) No 1831/2003, or, where the maximum levels for residues of pharmacologically active substances resulting from the unavoidable carry-over of these substances in non-target feed, set on the basis of Regulation (EC) No 315/93, have been exceeded, thereby establishing non-compliance, the competent authority, shall:
carry out any necessary measure or investigation, which it deems appropriate in relation to the finding in question. This may include any investigation in the farm of origin or departure of the animals, including controls on animals or batches of animals on their farms of origin or place of departure, to determine the extent and origin of non-compliance and to establish the extent of the operator’s responsibilities;
request the animal keeper or the responsible veterinarian to provide the prescription and treatment records and any documentation, justifying the nature of the treatment.
Where illegal treatment is suspected or established, or where substances falling under the scope of Directive 96/22/EC are discovered in the possession of non-authorised persons or operators, or where prohibited or unauthorised substances or products are discovered in the possession of non-authorised persons or operators, the competent authority shall:
immediately place the livestock and products concerned by the investigation under official detention.
during official detention the competent authority shall:
request the animal keeper and the responsible veterinarian to provide any documentation justifying the nature of the treatment;
carry out any other official controls on animals or batches of animals at the farm of origin or place of departure of the animals, necessary to ascertain such use;
carry out any other official controls necessary to ascertain the acquisition and presence of unauthorised or prohibited substances;
carry out any other official controls deemed necessary to clarify the origin of the prohibited or unauthorised substances or products or of the treated animals.
Article 5
Follow-up on residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives, exceeding the applicable maximum residue limits or maximum levels
Where the maximum residue limits for pharmacologically active substances authorised in veterinary medicinal products or as feed additives, set on the basis of Regulation (EC) No 470/2009 and Regulation (EC) No 1831/2003 have been exceeded or, where the maximum levels for residues of pharmacologically active substances resulting from the unavoidable carry-over of these substances in non-target feed, set on the basis of Regulation (EEC) No 315/93, have been exceeded, the competent authority shall:
Article 6
Follow-up of illegal treatments and the possession of prohibited or unauthorised substances or products
Where illegal treatment is established or where substances falling under the scope of Directive 96/22/EC, prohibited or unauthorised substances or products are discovered in the possession of non-authorised operators or persons, the competent authority shall:
For the purposes of paragraph 2:
The farms or establishments, supplying the holding concerned by the non-compliance, as well as all farms in the same supply chain of animals and animal feed as the farm of origin or departure may be subject to official controls to determine the origin of the substance in question:
Article 7
Requirements for analytical methods and sampling
All samples referred to in this Regulation shall be taken and analysed in accordance with Regulation (EU) 2017/625, Commission Decision 1998/179/EC ( 2 ) and Commission Decision 2002/657/EC ( 3 ).
Article 8
Actions on registration, authorisation and official approval arrangements
Where the possession, use or manufacture of unauthorised substances or products is confirmed, all registration, authorisation or official approval arrangements enjoyed by the establishment or the operator concerned shall be suspended for a period established by the competent authority.
In case of a repeat offence, such arrangements shall be withdrawn by the competent authority. In case of withdrawal, the operator shall be required to re-apply for the concerned registration, authorization or official approval arrangements and demonstrate its compliance with relevant requirements in this regard.
Article 9
Administrative assistance
Where the non-compliance referred to in Articles 5 and 6 is ascertained in relation to animals or products of animal origin originating from another Member State, the competent authority carrying out the investigation shall send a notification of the established non-compliance in accordance with Articles 105 and 106 of Regulation (EU) 2017/625 and, if required, it shall issue a request for administrative assistance from the competent authority of the Member State of origin in accordance with Article 104 of that Regulation. The competent authority of the Member State of origin shall apply Articles 5 and 6 of this Regulation to the farm or establishment of origin or departure.
Article 10
References
References to Article 13, Article 15(3), Article 16(2), Article 16(3), Article 17, Article 18, and Articles 22 to 25 of Directive 96/23/EC shall be construed as references to this Regulation and read in accordance with the correlation table in the Annex.
Article 11
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 14 December 2019 onwards.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX
CORRELATION TABLE REFERRED TO IN ARTICLE 10
Directive 96/23/EC |
This Regulation |
Article 13 |
Article 4 |
Article 15(3) |
Article 4, 5, 6 and 9 |
Article 16(2) |
Article 4, 5 and 6 |
Article 17 |
Article 6 |
Article 18 |
Article 5 |
Article 22 |
Article 6(1) |
Article 23(1) |
Article 4(4) |
Article 23(2), 23 (3), 23 (4) and 23 (5) |
Article 6 |
Article 24 |
Article 3 |
Article 25 |
Article 8 |
( 1 ) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).
( 2 ) Commission Decision 1998/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products (OJ L 65, 5.3.1998, p. 31).
( 3 ) Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8)