Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (Text with EEA relevance)
- (1) Article 8 is amended as follows:
- (a) paragraph 1 is deleted;
- (b) paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of these reports to the Member States.’;
- (c) in paragraph 3, point (a) is deleted;
- (2) Article 9 is deleted.
Article 153
Amendments to Regulation (EC) No 999/2001
Regulation (EC) No 999/2001 is amended as follows:
- (1) Articles 19 and 21 are deleted;
- (2) in Annex X, Chapters A and B are deleted.
Article 154
Amendments to Regulation (EC) No 1/2005 and related transitional measures
Regulation (EC) No 1/2005 is amended as follows:
- (1) Article 2 is amended as follows:
- (a) point (d) is replaced by the following:
- ‘(d) “border inspection post” means a border control post as defined in Article 3(38) of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0019]);
- (b) point (f) is replaced the following:
- ‘(f) “competent authority” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625’;
- (c) point (i) is replaced by the following:
- ‘(i) “exit point” means an exit point as defined in Article 3(39) of Regulation (EU) 2017/625’;
- (d) point (p) is replaced by the following:
- ‘(p) “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625’.
- (2) Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 are deleted.
- (3) Article 27 is amended as follows:
- (a) paragraph 1 is deleted;
- (b) paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried by the competent authority to verify compliance with the requirements of this Regulation. The report shall be accompanied by an analysis of the major deficiencies detected and an action plan to address them.’;
- (4) Article 28 is deleted.
Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 of Regulation (EC) No 1/2005 shall continue to apply, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.
The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 21.
Article 155
Amendments to Regulation (EC) No 396/2005 and related transitional measures
Articles 26 and 27, Article 28(1) and (2) and Article 30 of Regulation (EC) No 396/2005 are deleted.
Article 26, Article 27(1) and Article 30 of Regulation (EC) No 396/2005 shall continue to apply instead of the corresponding provisions of this Regulation until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article.
The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 19.
Article 156
Amendments to Directive 2007/43/EC
Directive 2007/43/EC is amended as follows:
- (1) In Article 2(1), points (c) and (d) are replaced by the following:
- ‘(c) “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0020]);
- (d) “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625;
- (2) Article 7 is amended as follows:
- (a) paragraph 1 is deleted;
- (b) paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’.
Article 157
Amendments to Directive 2008/119/EC
Directive 2008/119/EC is amended as follows:
- (1) In Article 2, point (2) is replaced by the following:
- ‘2. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0021]).
- (2) Article 7 is amended as follows:
- (a) paragraphs 1 and 2 are deleted;
- (b) paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’;
- (3) Article 9 is deleted.
Article 158
Amendments to Directive 2008/120/EC
Directive 2008/120/EC is amended as follows:
- (1) In Article 2, point (10) is replaced by the following:
- ‘10. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0022]).
- (2) Article 8 is amended as follows:
- (a) paragraphs 1 and 2 are deleted;
- (b) paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’;
- (3) Article 10 is deleted.
Article 159
Amendments to Regulation (EC) No 1099/2009
Regulation (EC) No 1099/2009 is amended as follows:
- (1) In Article 2, point (q) is replaced by the following:
- ‘(q) “competent authorities” means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0023]).
- (2) Article 22 is deleted.
Article 160
Amendments to Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009 is amended as follows:
- (1) Article 3 is amended as follows:
- (a) point (10) is replaced by the following:
- ‘10. “competent authority” means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0024]).
- (b) point (15) is replaced by the following:
- ‘15. “transit” means transit as defined in Article 3(44) of Regulation (EU) 2017/625.’;
- (2) Articles 45, 49 and 50 are deleted.
Article 161
Amendments to Regulation (EC) No 1107/2009
Regulation (EC) No 1107/2009 is amended as follows:
- (1) Article 68 is amended as follows:
- (a) the first paragraph is replaced by the following: ‘Member States shall submit to the Commission by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation’;
- (b) the second and third paragraphs are deleted.
- (2) point (n) of Article 78(1) is deleted.
Article 162
Amendments to Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is amended as follows:
- (1) Article 36 is amended as follows:
- (a) the heading is replaced by the following: ‘Content of official controls’;
- (b) paragraphs 1 and 2 are deleted;
- (c) in paragraph 3, the introductory phrase is replaced by the following: ‘3. Official controls performed in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0025]) shall cover:
- (2) Article 37 is amended as follows:
- (a) in paragraph 1, the first subparagraph is replaced by the following: ‘1. In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by: (a) the competent authorities designated in accordance with Article 4 of Regulation (EU) 2017/625; or (b) delegated bodies as defined in Article 3(5) of Regulation (EU) 2017/625.’;
- (b) in paragraph 3, the first subparagraph is deleted;
- (c) in paragraph 4, the words ‘paragraphs 1 and 2’ are replaced by the words: ‘paragraph 2’;
- (3) Article 38 is deleted;
- (4) Article 39 is replaced by the following: ‘Article 39 Delegated bodies performing controls in third countries The delegated bodies performing controls in the third countries referred to in paragraph 2(b) of Article 37 shall be accredited to the relevant harmonised standard for “Conformity assessment- Requirements for bodies certifying products, processes and services”. These delegated bodies may be accredited either by a national accreditation body outside the Union, in accordance with Regulation (EC) No 765/2008, or by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.’.
Article 163
Amendments to Regulation (EU) No 652/2014
Regulation (EU) No 652/2014 is amended as follows:
- (1) Article 30(1) is replaced by the following: ‘1. To cover the costs they incur to implement the work programmes approved by the Commission, grants may be awarded to: (a) the European Union reference laboratories referred to in Article 93 of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0026]) and to the European Union reference centres referred to in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council ([^E0027]); (b) the European Union reference centres for animal welfare referred to in Article 95 of Regulation (EU) 2017/625; (c) the European Union reference centres for the authenticity and integrity of the agri-food chain referred to in Article 97 of Regulation (EU) 2017/625.
- (2) the following Article is inserted: ‘Article 30a Accreditation of national reference laboratories for plant health
Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants.
Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’.
Article 164
Amendments to Regulation (EU) 2016/429 and related transitional provisions
Regulation (EU) 2016/429 is amended as follows:
- (1) Article 4 is amended as follows:
- (a) point (33) is replaced by the following:
- ‘(33) “official control” means any form of control performed in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0028]);
- (b) point (51) is replaced by the following:
- ‘(51) “Traces” means a system component integrated into the IMSOC as referred to in Articles 131 to 136 of Regulation (EU) 2017/625;’;
- (c) point (53) is replaced by the following:
- ‘(53) “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625;’;
- (d) point (55) is replaced by the following:
- ‘(55) “competent authority” means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation and Regulation (EU) 2017/625, or any other authority to which that responsibility has been delegated;’;
- (2) in Article 229, paragraph (2) is replaced by the following: ‘2. The operators responsible for the consignment in question shall present consignments of animals, germinal products and products of animal origin from third countries or territories for the purposes of official control as provided for in Article 47 of Regulation (EU) 2017/625.’;
- (3) Article 281 is deleted.
The following provisions shall continue to apply in relation to the matters governed by Regulation (EU) 2016/429, until the date of application of that Regulation:
- (a) Article 9 of Directive 89/662/EEC;
- (b) Article 10 of Directive 90/425/EEC;
- (c) Article 18(1), (3), (4), (5), (6), (7) and (8) of Directive 91/496/EEC;
- (d) Article 22(1), (3), (4), (5), (6) and (7) of Directive 97/78/EC.
Having regard to Article 14 of Regulation (EU) 2016/429 and notwithstanding the date of application provided for in that Regulation, for the purpose of Article 31(2) of this Regulation, the condition for its application shall be considered to be fulfilled already from 14 December 2019.
Article 165
Amendments to Regulation (EU) 2016/2031 and related transitional provisions
Regulation (EU) 2016/2031 is amended as follows:
- (1) Article 2, point (6) is replaced by the following:
- ‘(6) “competent authority” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ([^E0029]);
- (2) Article 10 is replaced by the following: ‘Article 10 Official confirmation by the competent authorities of the presence of a Union quarantine pest Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (“to officially confirm”), whether that pest is present or not. Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest. The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’;
- (3) in Article 11, the second paragraph is replaced by the following: ‘Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation (EU) 2017/625, of the Member State concerned and through the electronic notification system referred to in Article 103.’;
- (4) in Article 25(2), point (a) is replaced by the following: ‘(a)the roles and responsibilities of the bodies involved in the execution of the plan, in case of a confirmed or suspected presence of the priority pest concerned, as well as the chain of command and procedures for the co-ordination of actions to be taken by competent authorities, other public authorities, as referred to in Article 4(2) of Regulation (EU) 2017/625, delegated bodies or natural persons involved, as referred to in Article 28(1) of that Regulation, laboratories and professional operators, including the co-ordination with neighbouring Member States and neighbouring third countries, where appropriate;’;
- (5) in Article 41, paragraph 4 is replaced by the following: ‘4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation (EU) 2017/625, and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’;
- (6) in Article 44, paragraph 2 is replaced by the following: ‘2. Where appropriate, the Commission shall carry out investigations in the third country concerned and in accordance with Article 120 of Regulation (EU) 2017/625, to verify whether the conditions referred to in points (a) and (b) of the first subparagraph of paragraph 1 of this Article are fulfilled.’;
- (7) in Article 49(6), the third subparagraph is replaced by the following: ‘Member States shall notify, through the electronic notification system referred to in Article 103 of this Regulation, the Commission and the other Member States of any case where the introduction of a plant, plant product or other object into the Union territory was refused, or its movement within the Union territory prohibited, because the Member State concerned considered that the prohibition referred to in point (c) of the second subparagraph of paragraph 2 of this Article was violated. Where applicable, that notification shall include the measures taken by that Member State on the plants, plant products or other objects concerned pursuant to Article 66(3) of Regulation (EU) 2017/625.’;
- (8) in Article 76, paragraphs 4 and 5 are replaced by the following: ‘4. In the case of a third country which is not a contracting party to the IPPC, the competent authority shall only accept the phytosanitary certificates issued by the authorities which are competent in accordance with the national rules of that third country and notified to the Commission. The Commission shall inform the Member States and the operators, through the electronic notification system referred to in Article 103, in accordance with point (a) of Article 132 of Regulation (EU) 2017/625, of the notifications received. The Commission is empowered to adopt delegated acts, in accordance with Article 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph, to ensure the reliability of those certificates.
Electronic phytosanitary certificates shall only be accepted when provided through, or in electronic exchange with, the IMSOC referred to in Article 131(1) of Regulation (EU) 2017/625.’;
- (9) in Article 77(1), the first subparagraph is replaced by the following: ‘1. Where a phytosanitary certificate has been issued in accordance with Article 71(1), (2) and (3), and the competent authority concerned concludes that the conditions referred to in Article 76 are not fulfilled, it shall invalidate that phytosanitary certificate and ensure that it does not accompany any longer those plants, plant products or other objects concerned. In that case, and in respect of the plants, plant products or other objects concerned, the competent authority shall take one of the measures set out in Article 66(3) of Regulation (EU) 2017/625.’;
- (10) in Article 91(1), the second subparagraph is replaced by the following: ‘Authorised operators implementing an approved pest risk management plan may be subject to inspections with a reduced frequency, as referred to in point (b) of Article 22(3) of Regulation (EU) 2017/625.’;
- (11) in Article 94(1), the first subparagraph is replaced by the following: ‘1. By way of derogation from Article 87 of this Regulation, where a plant, plant product or other object, introduced into the Union territory from a third country which, for movement within the Union territory, requires a plant passport pursuant to Article 79(1) and 80(1) of this Regulation, the passport shall be issued if the checks under Article 49(1) of Regulation (EU) 2017/625 concerning its introduction have been completed satisfactorily and have led to the conclusion that the plant, plant product or other object concerned fulfils the substantive requirements for issuance of a plant passport in accordance with to Article 85 of this Regulation and, where appropriate, Article 86 of this Regulation.’;
- (12) in Article 100, paragraph 5 is replaced by the following: ‘5. Electronic phytosanitary certificates for export shall be provided through, or in electronic exchange with, the IMSOC.’;
- (13) in Article 101, paragraph 6 is replaced by the following: ‘6. Electronic phytosanitary certificates for re-export shall be provided through, or in electronic exchange with, the IMSOC.’;
- (14) in Article 102, paragraph 4 is replaced by the following: ‘4. The pre-export certificate shall accompany the plants, plant products and other objects concerned during their movement within the Union territory, unless the information contained in it is exchanged between the Member States concerned through, or in electronic exchange with, the IMSOC.’;
- (15) Article 103 is replaced by the following: ‘Article 103 Establishment of electronic notification system The Commission shall establish an electronic system for the submission of notifications by the Member States. That system shall be connected to, and compatible with, the IMSOC.’;
- (16) in Article 109, paragraph 1 is replaced by the following: ‘Directive 2000/29/EC is repealed, without prejudice to Article 165(2), (3) and (4) of Regulation (EU) 2017/625.’.
In relation to matters governed by Directive 2000/29/EC, Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), and point (a) of Article 58 of this Regulation shall apply from 15 December 2019 instead of the relevant provisions of that Directive, which shall cease to be applicable as of the same date.
The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by points (a) of Article 53(1) of this Regulation instead of that latter provision until 13 December 2020.
The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by Article 54(1) and (3) of this Regulation instead of these latter provisions until 13 December 2022.
The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article.
Without prejudice to paragraphs 2 and 3 of this Article and the date of application provided for in Article 167(1), the Commission shall adopt the delegated acts referred to in points (a) and (e) of Article 53(1), as regards goods referred to in point (c) of Article 47(1), at the latest 12 months before their date of application.
Article 166
Transitional measures for the adoption of delegated and implementing acts
Without prejudice to the dates of application referred to in Article 167 and transitional provisions provided for in this Chapter, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 28 April 2017. Such acts shall apply from the date of application in accordance with Article 167, without prejudice to any transitional rules provided for in this Chapter.
Article 167
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.
Unless otherwise provided for in paragraphs 2 to 4, it shall apply from 14 December 2019.
In the area governed by the rules referred to in point (g) of Article 1(2), Article 34(1), (2) and (3), point (e) of Article 37(4) and Article 37(5) shall apply from 29 April 2022.
Articles 92 to 101 of this Regulation shall apply from 29 April 2018, instead of Articles 32 and 33 of Regulation (EC) No 882/2004, which is repealed by this Regulation.
Article 163 shall apply from 28 April 2017.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
TERRITORIES REFERRED TO IN POINT 40 OF ARTICLE 3, EXCEPT FOR THE APPLICATION OF POINT (G) OF ARTICLE 1(2)
-
- The territory of the Kingdom of Belgium
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- The territory of the Republic of Bulgaria
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- The territory of the Czech Republic
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- The territory of the Kingdom of Denmark with the exception of the Faroe Islands and Greenland
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- The territory of the Federal Republic of Germany
-
- The territory of the Republic of Estonia
-
- The territory of Ireland
-
- The territory of the Hellenic Republic
-
- The territory of the Kingdom of Spain with the exception of Ceuta and Melilla
-
- The territory of the French Republic
-
- The territory of the Republic of Croatia
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- The territory of the Italian Republic
-
- The territory of the Republic of Cyprus
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- The territory of the Republic of Latvia
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- The territory of the Republic of Lithuania
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- The territory of the Grand Duchy of Luxembourg
-
- The territory of Hungary
-
- The territory of the Republic of Malta
-
- The territory of the Kingdom of the Netherlands in Europe
-
- The territory of the Republic of Austria
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- The territory of the Republic of Poland
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- The territory of the Portuguese Republic
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- The territory of Romania
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- The territory of the Republic of Slovenia
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- The territory of the Slovak Republic
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- The territory of the Republic of Finland
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- The territory of the Kingdom of Sweden
-
- The territory of the United Kingdom of Great Britain and Northern Ireland
ANNEX II
TRAINING OF STAFF OF THE COMPETENT AUTHORITIES
CHAPTER I
Subject matter for the training of staff performing official controls and other official activities
-
- Different control methods and techniques, such as inspection, verification, screening, targeted screening, sampling, and laboratory analysis, testing and diagnosis
-
- Control procedures
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- The rules referred to in Article 1(2)
-
- Assessment of non-compliance with the rules referred to in Article 1(2)
-
- The hazards in the production, processing and distribution of animals and goods
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- The different stages of production, processing and distribution, and the possible risks to human health, and where appropriate to the health of animals and plants, to the welfare of animals, to the environment
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- The evaluation of the application of HACCP procedures and of good agricultural practices
-
- Management systems such as quality assurance programmes that the operators manage and their assessment in so far as these are relevant for the requirements set out in the rules referred to in Article 1(2)
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- Official certification systems
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- Contingency arrangements for emergencies, including communication between Member States and the Commission
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- Legal proceedings and implications of official controls
-
- Examination of written, documentary material and other records, including those related to inter-laboratory comparative testing, accreditation and risk assessment, which may be relevant to the assessment of compliance with the rules referred to in Article 1(2); this may include financial and commercial aspects
-
- Control procedures and requirements for entry into the Union of animals and goods arriving from third countries
-
- Any other area necessary to ensure that official controls are performed in accordance with this Regulation
CHAPTER II
Subject areas for control procedures
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- The organisation of the competent authorities and the relationship between central competent authorities and authorities to which they have conferred tasks to perform official controls or other official activities
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- The relationship between competent authorities and delegated bodies or natural persons to which they have delegated tasks related to official controls or other official activities
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- A statement on the objectives to be achieved
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- Tasks, responsibilities and duties of staff
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- Sampling procedures, control methods and techniques, including laboratory analysis, testing and diagnosis, interpretation of results and consequent decisions
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- Screening and targeted screening programmes
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- Mutual assistance in the event that official controls require more than one Member State to take action
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- Action to be taken following official controls
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- Cooperation with other services and departments that may have relevant responsibilities or with operators
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- Verification of the appropriateness of methods of sampling and of laboratory analysis, testing and diagnosis
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- Any other activity or information required for the effective functioning of the official controls
ANNEX III
CHARACTERISATION OF METHODS OF ANALYSIS
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- Methods of analysis and measurement results should be characterised by the following criteria:
- (a) accuracy (trueness and precision),
- (b) applicability (matrix and concentration range),
- (c) limit of detection,
- (d) limit of quantification,
- (e) precision,
- (f) repeatability,
- (g) reproducibility,
- (h) recovery,
- (i) selectivity,
- (j) sensitivity,
- (k) linearity,
- (l) measurement uncertainty,
- (m) other criteria that may be selected as required.
-
- The precision values referred to in point 1(e) shall either be obtained from a collaborative trial which has been conducted in accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’) or, where performance criteria for analytical methods have been established, be based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally recognised form (e.g. the 95 % confidence intervals as defined by ISO 5725 ‘Accuracy (trueness and precision) of measurement methods and results’). The results from the collaborative trial shall be published or freely available.
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- Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities.
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- In situations where methods of analysis can only be validated within a single laboratory, those methods should be validated in accordance with internationally accepted scientific protocols or guidelines or, where performance criteria for analytical methods have been established, be based on criteria compliance tests.
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- Methods of analysis adopted under this Regulation should be edited in the standard layout for methods of analysis recommended by the ISO.
ANNEX IV
CHAPTER I
Fees or charges for the official controls on consignments of animals and goods entering the Union
I. CONSIGNMENTS OF LIVE ANIMALS
- (a) Bovine animals, equidae, pigs, sheep, goats, poultry, rabbits and small game birds or ground game, wild boar and wild ruminants:
- — EUR 55 per consignment, up to 6 tonnes, and
- — EUR 9 per tonne, over 6 and up to 46 tonnes, or
- — EUR 420 per consignment, over 46 tonnes.
- (b) Animals of other species:
- — EUR 55 per consignment, up to 46 tonnes, or
- — EUR 420 per consignment, over 46 tonnes.
II. CONSIGNMENTS OF MEAT
- — EUR 55 per consignment, up to 6 tonnes, and
- — EUR 9 per tonne, over 6 and up to 46 tonnes, or
- — EUR 420 per consignment, over 46 tonnes.
III. CONSIGNMENTS OF FISHERY PRODUCTS
- (a) Fishery products not in bulk:
- (i) EUR 55 per consignment, up to 6 tonnes, and
- (ii) EUR 9 per tonne, over 6 and up to 46 tonnes, or
- (iii) EUR 420 per consignment, over 46 tonnes.
- (b) Fishery products, transported as break bulk shipment:
- (i) EUR 600 per vessel, with a cargo of fishery products up to 500 tonnes,
- (ii) EUR 1 200 per vessel, with a cargo of fishery products over 500 and up to 1 000 tonnes,
- (iii) EUR 2 400 per vessel, with a cargo of fishery products over 1 000 and up to 2 000 tonnes,
- (iv) EUR 3 600 per vessel, with a cargo of fishery products of more than 2 000 tonnes.
IV. CONSIGNMENTS OF MEAT PRODUCTS, POULTRY MEAT, WILD GAME MEAT, RABBIT MEAT OR FARMED GAME MEAT
- (a) EUR 55 per consignment, up to 6 tonnes, and
- (b) EUR 9 per tonne, over 6 and up to 46 tonnes, or
- (c) EUR 420 per consignment, over 46 tonnes.
V. CONSIGNMENTS OF OTHER PRODUCTS OF ANIMAL ORIGIN DIFFERENT FROM MEAT PRODUCTS FOR HUMAN CONSUMPTION
- (a) Other products of animal origin for human consumption not in bulk;
- (i) EUR 55 per consignment, up to 6 tonnes, and
- (ii) EUR 9 per tonne, over 6 and up to 46 tonnes, or
- (iii) EUR 420 per consignment, over 46 tonnes.
- (b) Other products of animal origin for human consumption transported as break bulk shipment:
- (i) EUR 600 per vessel, with a cargo of products up to 500 tonnes,
- (ii) EUR 1 200 per vessel, with a cargo of products over 500 and up to 1 000 tonnes,
- (iii) EUR 2 400 per vessel, with a cargo of products over 1 000 and up to 2 000 tonnes,
- (iv) EUR 3 600 per vessel, with a cargo products of more than 2 000 tonnes.
VI. CONSIGNMENTS OF ANIMAL BY-PRODUCTS AND FEED OF ANIMAL ORIGIN
- (a) Consignment of animal by-product and feed of animal origin transported not in bulk:
- (i) EUR 55 per consignment, up to 6 tonnes, and
- (ii) EUR 9 per tonne, over 6 and up to 46 tonnes, or
- (iii) EUR 420 per consignment, over 46 tonnes.
- (b) Animal by-products and feed of animal origin, transported as break bulk shipment:
- (i) EUR 600 per vessel, with a cargo of products up to 500 tonnes,
- (ii) EUR 1 200 per vessel, with a cargo of products over 500 and up to 1 000 tonnes,
- (iii) EUR 2 400 per vessel, with a cargo of products over 1 000 and up to 2 000 tonnes,
- (iv) EUR 3 600 per vessel, with a cargo products of more than 2 000 tonnes.
VII. CONSIGNMENTS OF ANIMALS AND GOODS FROM THIRD COUNTRIES TRANSITING OR TRANSHIPPED
EUR 30 for consignment increased by EUR 20 per quarter of an hour for every member of staff involved in the controls.
VIII. CONSIGNMENTS OF PLANTS, PLANT PRODUCTS AND OTHER PRODUCTS, OBJECTS AND MATERIALS CAPABLE OF HARBOURING OR SPREADING PESTS OF PLANTS
- (a) For documentary checks: EUR 7 per consignment.
- (b) For identity checks:
- (i) EUR 7 per consignment up to a size of a truck load, a railway wagon load or the load of a container of comparable size,
- (ii) EUR 14 per consignment bigger than the above size.
- (c) For plant health checks, in accordance with the following specifications:
- (i) cuttings, seedlings (except forestry reproductive material), young plants of strawberries or of vegetables:
- — EUR 17,5 per consignment up to 10 000 in number,
- — EUR 0,70 per consignment for each additional 1 000 units,
- — EUR 140 per consignment maximum fee,
- (ii) shrubs, trees (other than cut Christmas trees), other woody nursery plants including forest reproductive material (other than seed):
- — EUR 17,5 per consignment up to 10 000 in number,
- — EUR 0,44 per consignment for each additional 1 000 units,
- — EUR 140 per consignment maximum fee,
- (iii) bulbs, corms, rhizomes, tubers, intended for planting (other than tubers of potatoes):
- — EUR 17,5 per consignment up to 200 kg of weight,
- — EUR 0,16 per consignment for each additional 10 kg,
- — EUR 140 per consignment maximum fee,
- (iv) seeds, tissue cultures:
- — EUR 7,5 per consignment up to 100 kg of weight,
- — EUR 0,175 per consignment for each additional 10 kg,
- — EUR 140 per consignment maximum fee,
- (v) other plants intended for planting, not specified elsewhere in this point:
- — EUR 17,5 per consignment up to 5 000 in number,
- — EUR 0,18 per consignment for each additional 100 units,
- — EUR 140 per consignment maximum fee,
- (vi) cut flowers:
- — EUR 17,5 per consignment up to 20 000 in number,
- — EUR 0,14 per consignment for each additional 1 000 units,
- — EUR 140 per consignment maximum fee,
- (vii) branches with foliage, parts of conifers (other than cut Christmas trees):
- — EUR 17,5 per consignment up to 100 kg of weight,
- — EUR 1,75 per consignment for each additional 100 kg,
- — EUR 140 per consignment maximum fee,
- (viii) cut Christmas trees:
- — EUR 17,5 per consignment up to 1 000 in number,
- — EUR 1,75 per consignment for each additional 100 units,
- — EUR 140 per consignment maximum fee,
- (ix) leaves of plants, such as herbs, spices and leafy vegetables:
- — EUR 17,5 per consignment up to 100 kg of weight,
- — EUR 1,75 per consignment for each additional 10 kg,
- — EUR 140 per consignment maximum fee,
- (x) fruits, vegetables (other than leafy vegetables):
- — EUR 17,5 per consignment up to 25 000 kg of weight,
- — EUR 0,7 per consignment for each additional 1 000 kg,
- (xi) tubers of potatoes:
- — EUR 52,5 per lot up to 25 000 kg of weight,
- — EUR 52,5 per lot for each additional 25 000 kg,
- (xii) wood (other than bark):
- — EUR 17,5 per consignment up to 1 000 m3 of volume,
- — EUR 0,175 per consignment for each additional 10 m3,
- (xiii) soil and growing medium, bark:
- — EUR 17,5 per consignment up to 25 000 kg of weight,
- — EUR 0,7 per consignment for each additional 1 000 kg,
- — EUR 140 per consignment maximum fee,
- (xiv) grain:
- — EUR 17,5 per consignment up to 25 000 kg of weight,
- — EUR 0,7 per consignment for each additional 1 000 kg,
- — EUR 700 per consignment maximum fee,
- (xv) other plants or plant products not specified elsewhere in this point:
- — EUR 17,5 per consignment.
Where a consignment does not consist exclusively of products coming under the description of the relevant indent, those parts thereof consisting of products coming under the description of the relevant indent (lot or lots) shall be treated as a separate consignment.
CHAPTER II
Fees or charges for the official controls in slaughterhouses, cutting plants, game-processing plants, milk production and producing and placing on the market fishery products and aquaculture products
I. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN SLAUGHTERHOUSES
- (a) Beef meat:
- (i) adult bovine animals: 5 EUR/animal,
- (ii) young bovine animals: 2 EUR/animal,
- (b) solipeds/equidae meat: 3 EUR/animal,
- (c) pigmeat: animals of a carcass weight:
- (i) of less than 25 kg: 0,5 EUR/animal,
- (ii) equal to or greater than 25 kg: 1 EUR/animal,
- (d) sheepmeat and goatmeat: animals of a carcass weight:
- (i) of less than 12 kg: 0,15 EUR/animal,
- (ii) equal to or greater than 12 kg: 0,25 EUR/animal,
- (e) poultry meat:
- (i) poultry of genus Gallus and guinea fowl: 0,005 EUR/animal,
- (ii) ducks and geese: 0,01 EUR/animal,
- (iii) turkeys: 0,025 EUR/animal,
- (iv) farmed rabbit meat: 0,005 EUR/animal,
- (v) quails and partridges: 0,002 EUR/animal.
II. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN CUTTING PLANTS
Per tonne of meat:
- (a) beef, veal, pig, solipeds/equidae, sheep and goatmeat: 2 EUR,
- (b) poultry and farmed rabbit meat: 1,5 EUR,
- (c) farmed and wild game meat:
- — small game birds and ground game: 1,5 EUR,
- — ratites (ostrich, emu, nandou): 3 EUR,
- — boar and ruminants: 2 EUR.
III. FEES OR CHARGES FOR THE OFFICIAL CONTROLS IN GAME-PROCESSING PLANTS
- (a) small game birds: 0,005 EUR/animal,
- (b) small ground game: 0,01 EUR/animal,
- (c) ratites: 0,5 EUR/animal,
- (d) land mammals:
- (i) boar: 1,5 EUR/animal,
- (ii) ruminants: 0,5 EUR/animal.
IV. FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON MILK PRODUCTION
- (a) 1 EUR per 30 tonnes and
- (b) 0,5 EUR/tonne thereafter.
V. FEES OR CHARGES FOR THE OFFICIAL CONTROLS ON PRODUCING AND PLACING ON THE MARKET FISHERY PRODUCTS AND AQUACULTURE PRODUCTS
- (a) First placing on the market of fishery and aquaculture products:
- (i) 1 EUR/tonne for the first 50 tonnes in the month;
- (ii) 0,5 EUR/tonne thereafter.
- (b) First sale in fish market
- (i) 0,5 EUR/tonne for the first 50 tonnes in the month;
- (ii) 0,25 EUR/tonne thereafter;
- (c) First sale in case of lack of or insufficient gradation for freshness and/or size:
- (i) 1 EUR/tonne for the first 50 tonnes in the month;
- (ii) 0,5 EUR/tonne thereafter.
ANNEX V
CORRELATION TABLES REFERRED TO IN ARTICLE 146(2)
1. Regulation (EC) No 882/2004
| Regulation (EC) No 882/2004 | This Regulation |
|---|---|
| Article 1(1), first subparagraph | Article 1(1) |
| Article 1(1), second subparagraph | Article 1(2) |
| Article 1(2) | Article 1(4) |
| Article 1(3) | — |
| Article 1(4) | — |
| Article 2 | Article 3 |
| Article 3(1) | Article 9(1) |
| Article 3(2) | Article 9(4) |
| Article 3(3) | Article 10 |
| Article 3(4) | Article 9(6) |
| Article 3(5) | Article 9(6) |
| Article 3(6) | Article 9(7) |
| Article 3(7) | — |
| Article 4(1) | Article 4(1) |
| Article 4(2) | Article 5(1)(a), (c), (d), (e), (f), (g) and (i) |
| Article 4(3) | Article 4(2) |
| Article 4(4) | Article 5(1)(b) |
| Article 4(5) | Article 5(5) |
| Article 4(6) | Article 6(1) |
| Article 4(7) | — |
| Article 5(1), first subparagraph | Article 28(1) |
| Article 5(1), second subparagraph | — |
| Article 5(1), third subparagraph | Article 31(3) |
| Article 5(2)(a), (b), (c) and (f) | Article 29 |
| Article 5(2)(d) | — |
| Article 5(2)(e) | Article 32 |
| Article 5(3) | Article 33 |
| Article 5(4) | — |
| Article 6 | Article 5(4) |
| Article 7(1), first subparagraph | Article 11(1), first subparagraph |
| Article 7(1), second subparagraph, point (a) | Article 11(1), second subparagraph |
| Article 7(1), second subparagraph, point (b) | — |
| Article 7(2), first sentence | Article 8(1) |
| Article 7(2), second sentence | — |
| Article 7(2), third sentence | — |
| Article 7(3) | Article 8 (3) |
| Article 8(1) | Article 12(1) |
| Article 8(2) | Article 5(1)(h) |
| Article 8(3)(a) | Article 12(2) |
| Article 8(3)(b) | Article 12(3) |
| Article 8(4) | — |
| Article 9(1) | Article 13(1), first subparagraph |
| Article 9(2) | Article 13(1), second subparagraph |
| Article 9(3) | Article 13(2) |
| Article 10 | Article 14 |
| Article 11(1) | Article 34(1) and (2) |
| Article 11(2) | — |
| Article 11(3) | Article 34(4) |
| Article 11(4) | Article 34(6) |
| Article 11(5) | Article 35(1) |
| Article 11(6) | Article 35(2) |
| Article 11(7) | Article 34(5) |
| Article 12(1) | Article 37(1) |
| Article 12(2) | Article 37(4)(e) |
| Article 12(3) | Article 37(5)(c) |
| Article 12(4) | Article 39(2) |
| Article 13 | Article 115 |
| Article 14(1) | — |
| Article 14(2) | Article 45(3) |
| Article 14(3) | — |
| Article 15(1) | Article 44(1), first sentence |
| Article 15(2) | Article 44(3) and (5) |
| Article 15(3) | Article 44(3) and (5) |
| Article 15(4) | — |
| Article 15(5) | Article 47(1)(d) and (2)(b) and Article 54(4), first sentence |
| Article 16(1) | Article 45(1) |
| Article 16(2) | Article 44(2) |
| Article 16(3), first sentence | Article 45(2) |
| Article 16(3), second sentence | Article 34(5) |
| Article 17(1), first indent | Article 59(1) |
| Article 17(1), second indent | Article 56(1), (3)(a) and (4) and Article 58 |
| Article 17(2) | — |
| Article 18 | Article 65(1), (2) and (3) |
| Article 19(1) | Article 66(1) and (3) |
| Article 19(2)(a) | Article 67 |
| Article 19(2)(b) | Article 66(6) |
| Article 19(3) | Article 66(5) |
| Article 19(4) | Article 7 |
| Article 20 | Article 71 |
| Article 21(1) | Article 72(1) |
| Article 21(2) | Article 69 |
| Article 21(3) | Article 66(1) |
| Article 21(4) | Article 66(5) |
| Article 22 | Article 66(7), 67, last sentence, and Article 69(4) |
| Article 23(1) | Article 73(1) |
| Article 23(2) | Article 73(2) and 74 |
| Article 23(3) | Article 73(3) |
| Article 23(4) | Article 73(2) |
| Article 23(5) | Article 73(4)(a) |
| Article 23(6) | Article 73(2)(c) and (4)(b) |
| Article 23(7) | Article 74 |
| Article 23(8) | Article 74 |
| Article 24(1) | Article 75(1) |
| Article 24(2) | Article 57 |
| Article 24(3) | Article 46 |
| Article 24(4) | Article 76 |
| Article 25(1) | — |
| Article 25(2)(a) | — |
| Article 25(2)(b) | Article 77(1)(c) |
| Article 25(2)(c) | Article 77(1)(f) |
| Article 25(2)(d) | Article 48(c) and (d) and Article 77(1)(e) and (k) |
| Article 25(2)(e) | — |
| Article 25(2)(f) | Article 70 |
| Article 25(2)(g) | Article 77(1)(h) |
| Article 25(2)(h) | Article 46(2)(b) |
| Article 26 | Article 78(1) |
| Article 27(1) | Article 80 |
| Article 27(2) | Article 79 |
| Article 27(3) | — |
| Article 27(4) | Article 79(1) |
| Article 27(5) | — |
| Article 27(6) | — |
| Article 27(7) | — |
| Article 27(8) | Article 84(2) |
| Article 27(9) | Article 83(2) |
| Article 27(10) | — |
| Article 27(11) | Article 84(1) |
| Article 27(12), first sentence | Article 85 |
| Article 27(12), second sentence | — |
| Article 28 | — |
| Article 29 | — |
| Article 30(1)(a) | Article 87 |
| Article 30(1)(b) | Article 90(a) |
| Article 30(1) (c) | Article 88(2) |
| Article 30(1)(d) | Article 90(b) and (f) |
| Article 30(1)(e) | Article 90(c) |
| Article 30(1)(f) | Article 90(d) |
| Article 30(1)(g) | Article 90(e) |
| Article 30(2)(a) | Article 89(1)(f) |
| Article 30(2)(b) | Article 89(1)(d) |
| Article 30(3) | — |
| Article 31 | — |
| Article 32(1)(a) | Article 94(2)(a) |
| Article 32(1)(b) | Article 94(2)(c) |
| Article 32(1)(c) | Article 94(2)(d) |
| Article 32(1)(d) | Article 94(2)(e) |
| Article 32(1)(e) | Article 94(2)(f) |
| Article 32(1)(f) | Article 94(2)(h) |
| Article 32(2)(a) | Article 94(2)(a), (c) and (d) |
| Article 32(2)(b) | Article 94(2)(i) |
| Article 32(2)(c) | Article 94(2)(e) |
| Article 32(2)(d) | Article 94(2)(h) |
| Article 32(2)(e) | Article 94(2)(e) |
| Article 32(3) | Article 93(3)(a) |
| Article 32(4)(a) | Article 93(3)(c) |
| Article 32(4)(b) | Article 93(3)(d) |
| Article 32(4)(c) | Article 93(3)(d) |
| Article 32(4)(d) | Article 8 |
| Article 32(4)(e) | Article 93(3)(e) |
| Article 32(4)(f) | Article 94(2)(k)(iii) |
| Article 32(4)(g) | Article 93(3)(e) |
| Article 32(4)(h) | Article 93(3)(f) |
| Article 32(5) | Article 99(1) |
| Article 32(6) | Article 99(2) |
| Article 32(7) | — |
| Article 32(8), first sentence | Article 99(3) |
| Article 32(8), second sentence | Article 99(4) |
| Article 32(9) | — |
| Article 33(1) | Article 100(1) |
| Article 33(2) | Article 101(1) |
| Article 33(3) | Article 100(2) |
| Article 33(4) | Article 100(4) |
| Article 33(5) | Article 100(5) |
| Article 33(6) | Article 101(2) |
| Article 33(7) | — |
| Article 34(1) | Article 102(1) |
| Article 34(2) | Article 102(1) and (2) |
| Article 34(3) | Article 102(3) |
| Article 35(1) | Article 103(1) |
| Article 35(2) | Article 103(3) |
| Article 35(3) | Article 103(2) |
| Article 35(4) | — |
| Article 36(1) | Article 104(1)(c) |
| Article 36(2), first sentence | — |
| Article 36(2), second sentence | Article 104(2) |
| Article 36(3), first subparagraph | Article 104(3), first sentence |
| Article 36(3), second subparagraph | — |
| Article 36(3), third subparagraph, first sentence | Article 104(3)(c) |
| Article 36(3), third subparagraph, second sentence | Article 104(3)(b) |
| Article 36(4) | Article 104(3)(a) |
| Article 37(1) | Article 105(1) |
| Article 37(2) | Article 105(2) |
| Article 38(1) | Article 106(1) |
| Article 38(2) | Article 106(2)(c) |
| Article 38(3) | Article 106(3) |
| Article 39(1) | Article 107(1) |
| Article 39(2) | Article 107(2) |
| Article 40(1) | Article 108(1) |
| Article 40(2) | — |
| Article 40(3) | Article 108(2) |
| Article 40(4) | — |
| Article 41 | Article 109(1) |
| Article 42(1)(a) | — |
| Article 42(1)(b) | Article 111(2) |
| Article 42(1)(c) | Article 111(3) |
| Article 42(2) | Article 110(2) |
| Article 42(3) | Article 111(2) |
| Article 43(1), first sentence | — |
| Article 43(1), second sentence | — |
| Article 43(1)(a) | — |
| Article 43(1)(b) | — |
| Article 43(1)(c) | — |
| Article 43(1)(d) to (j) | — |
| Article 43(1)(k) | — |
| Article 43(2) | — |
| Article 44(1) | Article 113(1) |
| Article 44(2) | — |
| Article 44(3) | Article 113(1) |
| Article 44(4), first subparagraph, first sentence | Article 114(1) |
| Article 44(4), first subparagraph, second sentence | Article 114(2) |
| Article 44(5) | — |
| Article 44(6) | Article 114(1) |
| Article 45(1) | Article 116(1)(2) and (4) |
| Article 45(2) | Article 116(3) |
| Article 45(3) | Article 117 |
| Article 45(4) | Article 118 |
| Article 45(5) | Article 119 |
| Article 45(6) | — |
| Article 46(1), first sentence | Article 120(1) |
| Article 46(1), second sentence | Article 120(4) |
| Article 46(1), third sentence | Article 120(2) |
| Article 46(2) | Article 120(3) |
| Article 46(3) | Article 121 |
| Article 46(4) | — |
| Article 46(5) | — |
| Article 46(6) | Article 122 |
| Article 46(7) | Article 123 |
| Article 47(1) | Article 125(1)(a) to (e) |
| Article 47(2) | Article 125(2) |
| Article 47(3) | Article 125(1)(f) and (g) |
| Article 47(4) | — |
| Article 47(5) | — |
| Article 48(1) | Article 126(1) |
| Article 48(2) | Article 126(2) |
| Article 48(3) | Article 127(1) and (2) |
| Article 48(4) | Article 127(3) |
| Article 48(5), first sentence | Article 127(3)(f) |
| Article 48(5), second and third sentence | — |
| Article 49 | Article 129 |
| Article 50 | — |
| Article 51(1) | Article 130(1) and (2) |
| Article 51(2) | Article 130(3) |
| Article 51(3) | — |
| Article 52 | Article 124 |
| Article 53 | Article 112 |
| Article 54(1) | Article 138(1) |
| Article 54(2) | Article 138(2) |
| Article 54(3) | Article 138(3) |
| Article 54(4) | Article 105(1) |
| Article 54(5) | Article 138(4) |
| Article 55(1) | Article 139(1) |
| Article 55(2) | Article 139(1) |
| Article 56(1) | Article 141(1) |
| Article 56(2)(a) | — |
| Article 56(2)(b) | Article 141(2) |
| Articles 57 to 61 | — |
| Article 62 | Article 145 |
| Article 63(1) | — |
| Article 63(2) | Article 25 |
| Article 64, first subparagraph | Article 142(1) |
| Article 64, point (1) | Article 142(1) |
| Article 64, point (2) | Article 142(2) |
| Article 65 | — |
| Article 66 | — |
| Article 67 | — |
| Annex I | Annex I |
| Annex II | Annex II |
| Annex III | Annex III |
| Annex IV | — |
| Annex V | — |
| Annex VI | Article 81 and 82(2) |
| Annex VII | — |
| Annex VIII | — |
2. Directive 96/23/EC
| Directive 96/23/EC | This Regulation |
|---|---|
| Article 1 | — |
| Article 2(a) | Article 19 |
| Article 2(b) | — |
| Article 2(c) | Article 19 |
| Article 2(d) | Article 3(3) |
| Article 2(e) | Article 19 |
| Article 2(f) | Article 37(1) |
| Article 2(g) | — |
| Article 2(h) | Article 19 |
| Article 2(i) | — |
| Article 3 | Article 9(1) and (2), Article 19, Article 109(1) and Article 112 |
| Article 4(1) | Article 4(1) |
| Article 4(2) | Article 4(2)(a), Article 109(2) and Article 113 |
| Article 4(3) | — |
| Article 5 | Article 111(2) and (3), Article 113(1)(a) and Article 110(2) |
| Article 6 | Article 19(2)(a) and (b) |
| Article 7 | Article 110(2) |
| Article 8(1) | — |
| Article 8(2) | — |
| Article 8(3), (4) and (5) | Articles 11, 113 and 114 |
| Article 9(A) | — |
| Article 9(B) | — |
| Article 10 | Article 15 |
| Article 11(1) and (2) | Articles 9 and 10 |
| Article 11(3) | Article 19(2)(c) and Articles 137 and 138 |
| Article 12, first paragraph | Article 9(4) |
| Article 12, second paragraph | Article 15 |
| Article 13 | Article 19(2)(c) and Articles 137 and 138 |
| Article 14(1) | Articles 100 and 101 |
| Article 14(2) | Article 93 |
| Article 15(1), first subparagraph | Article 19(2)(a) and (b) |
| Article 15(1), second subparagraph | Article 34(6) |
| Article 15(1), third subparagraph | — |
| Article 15(2), first subparagraph | Article 34(6) |
| Article 15(2), second subparagraph | Article 35(3) |
| Article 15(3) first, second and third subparagraphs | Article 19(2)(c) and Article 138 |
| Article 15(3), fourth subparagraph | Articles 65 to 72 |
| Article 16(1) | Articles 105(1) and 108(1) and Article 138 |
| Article 16(2) and (3) | Article 19(2)(c) and Article 138 |
| Article 17 | Article 19(2)(c) and Article 138 |
| Article 18 | Article 19(2)(c) and Article 138 |
| Article 19 | Article 138(4) |
| Article 20(1) | Articles 102 to 108 |
| Article 20(2), first subparagraph | Article 106(1) and (2) |
| Article 20(2), second subparagraph | Article 106(3) |
| Article 20(2), third and fourth subparagraphs | Article 108(1) |
| Article 20(2), fifth and sixth subparagraphs | Article 108(2) |
| Article 21 | Articles 116, 117 and 119 |
| Article 22 | Article 137 |
| Article 23 | Article 19(2)(c) and Article 138 |
| Article 24(1) and (2) | Articles 18(2)(d) and 19(2)(c) and Articles 137 and 138 |
| Article 24(3) | Articles 18(2)(d) and 19(2)(c) and Article 138 |
| Article 25 | Article 19(2)(c) and Article 138(2) |
| Article 26 | Article 7 |
| Article 27 | Article 139 |
| Article 28 | Article 139 |
| Article 29(1) and (2) | Articles 125, 126, 127 and 129 |
| Article 29(3) | Articles 47 to 64 |
| Article 29(4) | Article 113(1) |
| Article 30(1) and (2) | Articles 65 to 72 |
| Article 30(3) | Article 129(3) |
| Article 31 | Articles 78 to 85 |
| Article 33 | Article 145 |
| Article 34 | Article 19(2)(a) and (b) |
| Article 35 | — |
| Article 36 | — |
| Article 37 | — |
| Article 38 | — |
| Article 39 | — |
| Annex I | Article 19(2)(a) and (b) |
| Annex II | Article 19(2)(a) and (b) |
| Annex III | Article 19(2)(a) and (b) |
| Annex IV | Article 19(2)(a) and (b) |
3. Directives 89/662/EEC and 90/425/EEC
| Directive 89/662/EEC | This Regulation |
|---|---|
| Article 1 | — |
| Article 2(1), (2) and (3) | — |
| Article 2(4) | Article 3(3) |
| Article 2(5) | Article 3(32) |
| Article 3(1), first and second subparagraphs | — |
| Article 3(1), third subparagraph | Article 9(1) |
| Article 3(1), fourth subparagraph | Article 137(2) and (3) and Article 138 |
| Article 3(2) | — |
| Article 3(3) | — |
| Article 4(1), first sentence | Article 9(1), Articles 10, 137 and 138 |
| Article 4(1), first indent | Article 9(6)(a) |
| Article 4(1), second indent | — |
| Article 4(2) | Article 139 |
| Article 5(1)(a), first subparagraph | Article 9 |
| Article 5(1)(a), second subparagraph | Article 137(2) and (3) |
| Article 5(1)(b) | — |
| Article 5(2) | — |
| Article 5(3)(a), (b) and (d) | — |
| Article 5(3)(c) | Article 9(7) |
| Article 5(4) and (5) | — |
| Article 6(1) | Article 49 |
| Article 6(2) | — |
| Article 7(1) | Articles 102 to 108 and Article 138 |
| Article 7(2) | — |
| Article 8(1) | Articles 102 to 108 |
| Article 8(2) | Article 7 and Article 138(3) |
| Article 8(3) | Article 138(4) |
| Article 9 | — |
| Article 10 | Article 4(1) |
| Article 11 | Articles 10, 14 and 15 |
| Article 12 | — |
| Article 13 | — |
| Article 14 | — |
| Article 15 | — |
| Article 16(1) | Article 113(1) |
| Article 16(2) | — |
| Article 16(3) | Article 113(2) |
| Article 17 | Article 145 |
| Article 18 | Article 145 |
| Article 19 | — |
| Article 20 | — |
| Article 22 | — |
| Article 23 | — |
| Annex A | — |
| Annex B | — |
| Directive 90/425/EEC | This Regulation |
| --- | --- |
| Article 1 | — |
| Article 2(1) to (5) | — |
| Article 2(6) | Article 3(3) |
| Article 2(7) | Article 3(32) |
| Article 3(1) and (2) | — |
| Article 3(3) | Article 9, Article 137(2) and (3) and Article 138 |
| Article 3(4) | — |
| Article 4(1) | Article 9 |
| Article 4(2) | — |
| Article 4(3) | Article 139 |
| Article 5(1)(a), first subparagraph | Article 9 |
| Article 5(1)(a), second subparagraph | Article 137(2) and (3) |
| Article 5(1)b(i), first subparagraph | — |
| Article 5(1)(b)(i), second subparagraph | Article 9 |
| Article 5(1)(b)(ii), (iii) and (iv) | — |
| Article 5(2)(a), first subparagraph | Article 9(7) |
| Article 5(2)(a), second and third subparagraphs | — |
| Article 5(2)(b) | — |
| Article 5(3) | — |
| Article 6 | — |
| Article 7(1) | Article 49 |
| Article 7(2) | — |
| Article 8(1) | Articles 102 to 108 and Article 138 |
| Article 8(2) | — |
| Article 9(1) | Articles 102 to 108 |
| Article 9(2) | Articles 7 and 138(3) |
| Article 9(3) | Article 138(4) |
| Article 9(4) | — |
| Article 10 | — |
| Article 11 | Article 4(1) |
| Article 12 | — |
| Article 13 | Articles 10, 14 and 15 |
| Article 14 | — |
| Article 15 | — |
| Article 16 | — |
| Article 17 | Article 145 |
| Article 18 | Article 145 |
| Article 19 | Article 145 |
| Article 20 | Articles 131, 132, 133 and 134 |
| Article 21 | — |
| Article 22(1) | Article 113(1) |
| Article 22(2) | — |
| Article 22(3) | Article 113(2) |
| Article 23 | — |
| Article 24 | — |
| Article 26 | — |
| Article 27 | — |
| Annex A | — |
| Annex B | — |
| Annex C | — |
4. Directives 97/78/EC and 91/496/EEC
| Directive 97/78/EC | This Regulation |
|---|---|
| Article 1 | — |
| Article 2 | Article 3 |
| Article 2(2)(a) | Article 3(19) |
| Article 2(2)(b) | Article 3(41) |
| Article 2(2)(c) | Article 3(42) |
| Article 2(2)(d) | Article 3(43) |
| Article 2(2)(e) | — |
| Article 2(2)(f) | Article 3(37) |
| Article 2(2)(g) | Article 3(38) |
| Article 2(2)(h) | — |
| Article 2(2)(i) | — |
| Article 2(2)(j) | — |
| Article 2(2)(k) | Article 3(3) |
| Article 3(1) and (2) | Article 47(1) |
| Article 3(3) | Article 15 and Article 56(1) and (3) |
| Article 3(4) | Article 57 |
| Article 3(5) | Article 47(2) and (3) and Article 58 |
| Article 4(1) | Article 49(2) |
| Article 4(2) | — |
| Article 4(3) and (4) | Article 49(1), (2) and (3) and Article 52 |
| Article 4(5) | Article 52 |
| Article 5(1) | Article 56(3)(b) and (4) |
| Article 5(2) | Article 50(4) |
| Article 5(3) | Article 50(2) and (3) |
| Article 5(4) | Article 58 |
| Article 6(1)(a), first paragraph | Article 64(1) |
| Article 6(1)(a), second paragraph | Article 64(2) |
| Article 6(1)(b) | — |
| Article 6(2) | Articles 59 and 62 |
| Article 6(3) | Article 63 |
| Article 6(4) | Article 60(1) and Article 63(3) |
| Article 6(5) | — |
| Article 6(6) | Articles 60(2), 62(3), 63(5) and Article 64(2) and(4) |
| Article 7(1) | Article 50(1) |
| Article 7(2) | Article 49(1), (2) and (3) and Article 52 |
| Article 7(3) | Article 57 |
| Article 7(4) | Article 50(2), Article 55 and Article 56(4) |
| Article 7(5) | — |
| Article 7(6) | Articles 52 and 58 |
| Article 8(1) | — |
| Article 8(2) | Article 77(1)(b) |
| Article 8(3), (4), (5), (6), (7) | Article 77(2) |
| Article 9 | Article 51(1)(b) and (c) |
| Article 10(1), (2), (4) | Article 54(2) |
| Article 10(3) | — |
| Article 11 | Article 51(1)(d) |
| Article 12 | Articles 48(h) and 77(1)(k) |
| Article 13 | Article 77(1)(c) |
| Article 14 | — |
| Article 15 | Article 77(1)(h) |
| Article 16(1)(a) | Article 48(d) |
| Article 16(1)(b) | Article 48(e) |
| Article 16(1)(c) | Article 48(c) |
| Article 16(1)(d) | Article 48(g) |
| Article 16(1)(e) | Article 48(a) |
| Article 16(1)(f) | Article 48(b) |
| Article 16(2) | — |
| Article 16(3) | — |
| Article 16(4) | Article 77(1)(c) and (f) |
| Article 17(1) | Article 66(3) |
| Article 17(2) | Article 66(1), (2) and (3) |
| Article 17(2)(a) | Article 66(3)(b) and Articles 69 and 72 |
| Article 17(2)(a), first indent | — |
| Article 17(2)(a), second indent | Article 68(1)(a) |
| Article 17(2)(b) | Article 69 |
| Article 17(3) | Article 65(4), (5) and (6) |
| Article 17(4) | — |
| Article 17(5) | Articles 66(7) and 69(4) |
| Article 17(6) | — |
| Article 17(7) | Article 65(6), Article 70 and Article 71(3) |
| Article 18 | Article 64(2) |
| Article 19(1) | Article 77(1)(g) |
| Article 19(2) | Article 77(1)(a) |
| Article 19(3) | Article 64(3)(a) and (4) |
| Article 20(1) | Article 65 |
| Article 20(2) | — |
| Article 22(1) | — |
| Article 22(2) | Article 67 |
| Article 22(3) | — |
| Article 22(4) | — |
| Article 22(5) | — |
| Article 22(6) | — |
| Article 22(7) | — |
| Article 24 | Article 65(4), (5) and (6) |
| Article 24(3) | Articles 73 and 129 |
| Article 25(1) | Articles 102 to 108 |
| Article 25(2) | Article 7 |
| Article 25(3) | — |
| Article 26 | Article 130(5) and (6) |
| Article 27 | Article 5(4) and Article 130(1) and (6) |
| Article 28 | — |
| Article 29 | — |
| Article 30 | — |
| Article 31 | — |
| Article 32 | — |
| Article 33 | — |
| Article 34 | — |
| Article 35 | — |
| Article 36 | — |
| Annex I | Annex I |
| Annex II | Article 64 |
| Annex III | Article 52 |
| Directive 91/496/EEC | This Regulation |
| --- | --- |
| Article 1 | — |
| Article 2(1) | — |
| Article 2(2)(a) | Article 3(41) |
| Article 2(2)(b) | Article 3(42) |
| Article 2(2)(c) | Article 3(43) |
| Article 2(2)(d) | — |
| Article 2(2)(e) | Article 3(37) |
| Article 2(2)(f) | Article 3(38) |
| Article 3(1)(a) | Article 56(1) and (3)(a) and Article 58(b) |
| Article 3(1)(b) | Articles 47(1) and 66(2) |
| Article 3(1)(c)(i) | Article 56(3)(b) and (5) and Article 57 |
| Article 3(1)(c)(ii) | Article 79(1) |
| Article 3(1)(d) | Article 57 |
| Article 3(2) | — |
| Article 4(1) | Article 49(1) and Article 52 |
| Article 4(2) | Articles 49(1), (2) and (3) and Article 52 |
| Article 4(3) | Article 51(1)(c) |
| Article 4(4) | Article 79(1) |
| Article 4(5) | Articles 5(4) and 51(1)(c) and Article 52 |
| Article 5 | Article 55, Article 56(3)(b) and (5), Article 57, Article 58(a) and Article 66(1) |
| Article 6(1) | — |
| Article 6(2)(a) | Article 64(1) and (2) |
| Article 6(2)(b) | Article 64(1) |
| Article 6(2)(c) | Article 59 |
| Article 6(2)(d) | Article 64(3)(a) and (4) |
| Article 6(3) | Article 60 |
| Article 6(3)(a) | Article 60(1)(c) |
| Article 6(3)(b) | Article 60(1)(c) |
| Article 6(3)(c) | Articles 59(2) and 64(3) |
| Article 6(3)(d) | — |
| Article 6(3)(e) | Articles 59(2) and 64(3) |
| Article 6(3)(f) | Articles 59(2) and 64(3) |
| Article 6(3)(g) | — |
| Article 6(4) | Article 59 and Article 60(1) |
| Article 6(5) | Article 60(2) |
| Article 7(1), first indent | Article 50(2) |
| Article 7(1), second indent | Article 56(3)(b) and (5) and Article 58 |
| Article 7(1), third indent | Article 50(1) |
| Article 7(2) | Article 58 |
| Article 7(3) | — |
| Article 8 | Article 53(1)(b) |
| Article 9 | Article 51(1)(d) |
| Article 10 | Article 66(2) |
| Article 11(1) | Article 65 |
| Article 11(2) | — |
| Article 12(1) | Articles 66, 68 and 69 |
| Article 12(2) | Article 66(3) and Article 9 |
| Article 12(3) | Articles 70 and Articles 71(3) and 72(3) |
| Article 12(4) | — |
| Article 12(5) | — |
| Article 13 | Article 64(2) |
| Article 14 | — |
| Article 15 | Article 79(1) |
| Article 16 | Article 54 |
| Article 17 | Article 7 |
| Article 17a | — |
| Article 18(1) | — |
| Article 18(2) | Article 67 |
| Article 18(3) | — |
| Article 18(4) | — |
| Article 18(5) | — |
| Article 18(6) | — |
| Article 18(7) | — |
| Article 18(8) | — |
| Article 19 | Articles 116 and 117 |
| Article 20 | Articles 102 to 108 |
| Article 21 | Article 130(5) and (6) |
| Article 22 | — |
| Article 23 | — |
| Article 24 | — |
| Article 25 | — |
| Article 26 | — |
| Article 27 | — |
| Article 28 | — |
| Article 29 | — |
| Article 30 | — |
| Article 31 | — |
| Annex A | Article 64 |
| Annex B | Article 66(2) |
5. Directive 96/93/EC
| Directive 96/93/EC | This Regulation |
|---|---|
| Article 1 | — |
| Article 2(1), first subparagraph | — |
| Article 2(1), second subparagraph | Article 3(26) |
| Article 2(2) | Article 3 |
| Article 3(1) | Article 88(2)(b) |
| Article 3(2) | Article 88(3)(a) and (b) |
| Article 3(3) | Article 89(1)(b) |
| Article 3(4) | Article 88(3)(b) |
| Article 3(5) | Article 90 |
| Article 4(1) | Articles 88(2)(a) and 89(2) |
| Article 4(2) | Article 89(1)(c) |
| Article 4(3) | Article 89(1)(e) |
| Article 5 | Article 89(2) |
| Article 6 | Article 129 |
| Article 7 | Article 145 |
| Article 8 | — |
| Article 9 | — |
| Article 10 | — |
6. Directive 89/608/EEC
| Directive 89/608/EEC | This Regulation |
|---|---|
| Article 1 | — |
| Article 2 | — |
| Article 3 | Articles 102 to 108 |
| Article 4 | Articles 102 to 108 |
| Article 5 | Articles 102 to 108 |
| Article 6 | Articles 102 to 108 |
| Article 7 | Articles 102 to 108 |
| Article 8 | Articles 102 to 108 |
| Article 9 | Articles 102 to 108 |
| Article 10 | Article 8 and Articles 102 to 108 |
| Article 11 | — |
| Article 12 | Articles 102 to 108 |
| Article 13 | — |
| Article 14 | — |
| Article 15 | Article 8 and Articles 102 to 108 |
| Article 16 | — |
| Article 17 | — |
| Article 18 | — |
| Article 19 | — |
| Article 20 | — |
7. Decision 92/438/EEC
| Decision 92/438/EEC | This Regulation |
|---|---|
| Article 1 | Articles 131 to 136 |
| Article 2 | — |
| Article 3 | Articles 131 to 136 |
| Article 4 | Articles 131 to 136 |
| Article 5 | Articles 131 to 136 |
| Article 6 | Article 64(3)(f) |
| Article 7 | — |
| Article 8 | — |
| Article 9 | — |
| Article 10 | — |
| Article 11 | — |
| Article 12 | — |
| Article 13 | — |
| Article 14 | — |
| Article 15 | — |
| Annex I | Articles 131 to 136 |
| Annex II | Articles 131 to 136 |
| Annex III | Articles 131 to 136 |
8. Regulation (EC) No 854/2004
| Regulation (EC) No 854/2004 | This Regulation |
|---|---|
| Article 1(1) | Article 1(2)(a) |
| Article 1(1a) | — |
| Article 1(2) | — |
| Article 1(3) | — |
| Article 2(1)(c) | Article 3(3) |
| Article 2(1)(f) | Article 3(32) |
| Article 2(1)(g) | — |
| Article 2(1)(h) | Article 3(49) |
| Article 2(1)(i) | — |
| Article 2(2) | — |
| Article 3 | Article 148 |
| Article 4(1) | Article 15(1) and (2) |
| Article 4(2) | Article 18(1) |
| Article 4(3) | Article 18 |
| Article 4(4) | Article 18(2)(d) and (8)(a) |
| Article 4(5) | Article 18(2)(d) and (8)(a) |
| Article 4(6) | — |
| Article 4(7) | Article 17(a) and (b) and Article 18(2)(d) and (5) |
| Article 4(8) | Article 9(1) and Article 18(8)(a) |
| Article 4(9) | Article 9(1) and Article 18(8)(a) |
| Article 5 (1) | Article 17, Article 18(1) and (2), Article 18(7)(a) and (b) and Article 18(8)(a) and (d) |
| Article 5(2) | Article 17(a) and (b), Article 18(4), (5) and (8)(e) |
| Article 5(3) | Article 18(8)(c) and Article 138 |
| Article 5(4) | Article 17(a) and (b) and Article 18(5), (7)(a), (b), (e) and (j) and (8)(a) and (d) |
| Article 5(5) | Article 5(1)(e), (g) and (h) |
| Article 5(6) | Article 18(3), (4) and (7)(k) |
| Article 5(7) | Article 18(7)(j) |
| Article 6 | Article 18(6), (7)(g) and (8)(b) |
| Article 7 | Article 18(8)(a) |
| Article 8 | Article 18(8)(a) |
| Article 10 | — |
| Article 11 | Articles 126 and 127 |
| Article 12 | Article 126 |
| Article 13 | Article 126 and 127 |
| Article 14 | Article 126 |
| Article 15(1) | Article 18(1) and (8)(a) |
| Article 15(2) | Article 126 |
| Article 15(3) | Article 18(8)(a) |
| Article 15(4) | Article 18(8)(a) |
| Article 16, first paragraph | Article 18(7) |
| Article 16, second paragraph | Article 18(8) |
| Article 17(1) | Article 18(7) and (8) |
| Article 17(2) | Article 18(7) |
| Article 17(3) to (7), with the exception of cases referred to in (4)(a)(iii) | — |
| Article 17(3) to (8) applicable to cases referred to in (4)(a)(iii) | Article 18(9) |
| Article 18 | Article 18(7) and (8) |
| Article 19 | Article 145 |
| Article 20 | — |
| Article 21(1) | Article 114 |
| Article 22 | Article 167 |
| Annex I | Article 17, Article 18(1), (2), (3), (4), (7)(a), (b), (c), (d), (f), (k) and (j); (8)(a), (c), (d) and (e) |
| Annex II | Article 18(1), (6), (7)(g), (8)(a) and (b) |
| Annex III | Article 18(1) and (8)(a) |
| Annex IV | Article 18(1) and (8)(a) and (f) |
| Annex V | Article 126 |
| Annex VI | Article 126 |
[^E0001]: Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
[^E0002]: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
[^E0003]: Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).
[^E0004]: Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55).
[^E0005]: Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).
[^E0006]: Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).
[^E0007]: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
[^E0008]: Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (OJ L 35, 8.2.2005, p. 1).
[^E0009]: Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).
[^E0010]: Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
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