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)

Type Regulation
Publication 2017-04-07
Last updated 2025-01-05
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 167
Reform history JSON API
6.

In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for:

  • (a) the requests for assistance provided for in Article 104(1); and
  • (b) the communication of common and recurrent notifications and responses.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 103
Liaison bodies
1.

Each Member State shall designate one or more liaison bodies acting as contact points responsible for facilitating the exchange of communications between competent authorities in accordance with Articles 104 to 107.

2.

The designation of liaison bodies shall not preclude direct contacts, exchange of information or cooperation between the staff of competent authorities in different Member States.

3.

Member States shall communicate to the Commission and other Member States the contact details of their liaison bodies designated in accordance with paragraph 1, and any subsequent modification of those details.

4.

The Commission shall publish and update on its website the list of liaison bodies communicated to it by the Member States in accordance with paragraph 3.

5.

All requests for assistance pursuant to Article 104(1), and notifications and communications pursuant to Articles 105, 106 and 107 shall be transmitted by a liaison body to its correspondent in the Member State to which the request or the notification is addressed.

6.

The Commission shall, by means of implementing acts, establish the specifications of the technical tools and the procedures for communication between liaison bodies designated in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 104
Assistance on request
1.

Where the competent authorities in a Member State consider that, for the performance of official controls or for the effective follow-up to such controls in their territory, they require data or information from the competent authorities of another Member State, they shall issue a reasoned request for administrative assistance to the competent authorities of that Member State. The requested competent authorities shall:

  • (a) acknowledge receipt of the request without delay;
  • (b) where the requesting competent authority so specifies, indicate within ten working days from the date of receipt of the request, the estimated time necessary to provide an informed response to the request; and
  • (c) perform official controls or investigations necessary to provide the requesting competent authorities without delay with all necessary information and documents to enable them to take informed decisions and verify compliance with Union rules within their jurisdiction.
2.

Documents may be transmitted in their original form or copies may be provided.

3.

By agreement between the requesting competent authorities and the requested competent authorities, staff designated by the former may be present during the official controls and investigations referred to in point (c) of paragraph 1 performed by the requested competent authorities.

In such cases the staff of the requesting competent authorities shall:

  • (a) at all times be able to produce written authority stating their identity and their official capacity;
  • (b) be granted access by the operator to the same premises and documents as the staff of the requested competent authorities, through their intermediary, and for the sole purpose of the administrative enquiry being carried out; and
  • (c) not, on their own initiative, exercise the powers of enquiry conferred on officials of the requested competent authorities.
Article 105
Assistance without request in the event of non-compliance
1.

When the competent authorities in a Member State become aware of a case of non-compliance, and if such non-compliance may have implications for another Member State, they shall notify such information to the competent authorities of that other Member State without being requested to do so and without undue delay.

2.

The competent authorities notified in accordance with paragraph 1 shall:

  • (a) acknowledge receipt of the notification without undue delay;
  • (b) where the notifying competent authority so specifies, indicate within ten working days from the date of receipt of the notification:
  • (i) what investigations they intend to carry out; or
  • (ii) the reasons why they consider that no investigations are necessary; and
  • (c) where investigations referred to in point (b) are considered necessary, investigate the matter and inform the notifying competent authorities without delay of the results and, where appropriate, of any measures taken.
Article 106
Assistance in the event of non-compliance creating a risk or a repeated or potentially serious infringement
1.

Where, during official controls performed on animals or goods originating in another Member State, the competent authorities establish that such animals or goods do not comply with the rules referred to in Article 1(2) in such a way as to create a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or to constitute a potentially serious infringement of those rules, they shall, without delay, notify the competent authorities of the Member State of dispatch and of any other concerned Member State in order to enable those competent authorities to undertake appropriate investigations.

2.

The notified competent authorities shall without delay:

  • (a) acknowledge receipt of the notification;
  • (b) where the notifying competent authority so specifies, indicate what investigations they intend to carry out; and
  • (c) investigate the matter, take all necessary measures and inform the notifying competent authorities of the nature of the investigations and official controls performed, of the decisions taken and of the reasons for such decisions.
3.

If the notifying competent authorities have reason to believe that the investigations performed or the measures taken by the notified competent authorities do not adequately address the non-compliance established, they shall request the notified competent authorities to complement the official controls performed or the measures taken. In such cases the competent authorities from the two Member States shall:

  • (a) seek an agreed approach with the aim of appropriately addressing the non-compliance, including through joint official controls and investigations performed in accordance with Article 104(3); and
  • (b) inform the Commission without delay where they are not able to agree on appropriate measures.
4.

When official controls performed on animals or goods originating in another Member State show repeated cases of non-compliance as referred to in paragraph 1, the competent authorities of the Member State of destination shall inform the Commission and the competent authorities of the other Member States without delay.

Article 107
Assistance on the basis of information provided by third countries
1.

When competent authorities receive information from a third country indicating non-compliance with rules referred to in Article 1(2) or a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, they shall, without delay:

  • (a) notify such information to the competent authorities in other concerned Member States; and
  • (b) communicate such information to the Commission where it is or may be relevant at Union level.
2.

Information obtained through official controls and investigations performed in accordance with this Regulation may be communicated to the third country referred to in paragraph 1, provided that:

  • (a) the competent authorities which have provided the information consent to such communication;
  • (b) the third country has undertaken to provide the assistance necessary to gather evidence of practices that are or appear to be non-compliant with Union rules or that pose a risk to humans, animals or plants or the environment; and
  • (c) relevant Union and national rules applicable to the communication of personal data to third countries are complied with.
Article 108
Coordinated assistance and follow-up by the Commission
1.

Where the competent authorities in the Member States concerned are unable to agree on appropriate action to address the non-compliance with the rules referred to in Article 1(2), the Commission shall coordinate without delay the measures and actions undertaken by competent authorities in accordance with this Title where information available to the Commission either:

  • (a) reports activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2), and such activities have, or might have, ramifications in more than one Member State; or
  • (b) indicates that the same, or similar, activities that are, or appear to be, non-compliant with the rules referred to in Article 1(2) might be taking place in more than one Member State.
2.

In the cases referred to in paragraph 1, the Commission may:

  • (a) in collaboration with the Member State concerned, send an inspection team to perform an on-the-spot official control;
  • (b) request, by means of implementing acts, that the competent authorities in the Member State of dispatch and, where appropriate, in other Member States concerned, appropriately intensify official controls and report to it on the measures taken by them;
  • (c) take any other appropriate measure in accordance with the rules referred to in Article 1(2).
3.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by establishing rules for the rapid exchange of information in the cases referred to in paragraph 1.

TITLE V PLANNING AND REPORTING

Article 109
Multi-annual national control plans (MANCP) and a single body for the MANCP
1.

Member States shall ensure that official controls governed by this Regulation are performed by the competent authorities on the basis of a MANCP, the preparation and implementation of which are coordinated across their territory.

2.

Member States shall designate a single body tasked with:

  • (a) coordinating the preparation of the MANCP across all competent authorities responsible for the official controls;
  • (b) ensuring that the MANCP is coherent;
  • (c) collecting the information on the implementation of the MANCP in view of submitting the annual reporting referred to in Article 113 and of its review and update as necessary in accordance with Article 111(2).
Article 110
Content of the MANCPs
1.

MANCPs shall be prepared so as to ensure that official controls are planned in all the areas governed by the rules referred to in Article 1(2) and in accordance with the criteria laid down in Article 9 and with the rules provided for in Articles 18 to 27.

2.

MANCPs shall contain general information on the structure and organisation of the systems of official control in the Member State concerned in each of the areas covered, and shall contain information on at least the following:

  • (a) the strategic objectives of the MANCP and on how the prioritisation of official controls and allocation of resources reflect these objectives;
  • (b) the risk categorisation of the official controls;
  • (c) the designation of competent authorities and their tasks at central, regional and local level, and on resources available to those authorities;
  • (d) where appropriate, the delegation of tasks to delegated bodies;
  • (e) the general organisation and management of official controls at national, regional and local level, including official controls in individual establishments;
  • (f) control systems applied to different sectors and coordination between the different services of competent authorities responsible for official controls in those sectors;
  • (g) procedures and arrangements in place to ensure compliance with the obligations of the competent authorities provided for in Article 5(1);
  • (h) the training of staff of the competent authorities;
  • (i) the documented procedures provided for in Article 12(1);
  • (j) the general organisation and operation of contingency plans in accordance with the rules referred to in Article 1(2); and
  • (k) the general organisation of cooperation and mutual assistance between competent authorities in the Member States.
Article 111
Preparation, update and review of MANCPs
1.

Member States shall ensure that the MANCP provided for in Article 109(1) is made available to the public, with the exception of those parts of the plan the disclosure of which could undermine the effectiveness of official controls.

2.

The MANCP shall be regularly updated to adjust it to changes to the rules referred to in Article 1(2), and reviewed to take account at least of the following factors:

  • (a) the emergence of new diseases, pests of plants or other risks to human, animal or plant health, animal welfare or, in the case of GMOs and plant protection products, also to the environment;
  • (b) significant changes to the structure, management or operation of the competent authorities in the Member State;
  • (c) the outcome of Member States’ official controls;
  • (d) the outcome of Commission controls performed in the Member State in accordance with Article 116(1);
  • (e) scientific findings; and
  • (f) the outcome of official controls performed by the competent authorities of a third country in a Member State.
3.

Member States shall provide the Commission, upon request, with the latest up-to-date version of their respective MANCP.

Article 112
Coordinated control programmes and information and data collection

With a view to conducting Union-wide targeted assessment of the state of application of the rules referred to in Article 1(2) or establishing the prevalence of certain hazards across the Union, the Commission may adopt implementing acts concerning:

  • (a) the implementation of coordinated control programmes of limited duration in one of the areas governed by the rules referred to in Article 1(2);
  • (b) the organisation, on an ad hoc basis, of the collection of data and information in relation to the application of a specific set of the rules referred to in Article 1(2) or regarding the prevalence of certain hazards.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 113
Annual reports by the Member States
1.

By 31 August every year, each Member State shall submit to the Commission a report setting out:

  • (a) any amendments made to its MANCP to take account of the factors referred to in Article 111(2);
  • (b) the outcome of official controls performed in the previous year under its MANCP;
  • (c) the type and number of cases of non-compliance with the rules referred to in Article 1(2), per area, detected in the previous year by the competent authorities;
  • (d) the measures taken to ensure the effective operation of its MANCP, including enforcement action and the results of such measures, and
  • (e) a link to the web page of the competent authority containing the public information on fees or charges referred to in Article 85(2).
2.

In order to ensure the uniform presentation of the annual reports provided for in paragraph 1, the Commission shall, by means of implementing acts, adopt and update as necessary standard model forms for the submission of the information and data referred to in that paragraph.

Those implementing acts shall, whenever possible, allow the use of the standard model forms adopted by the Commission for the submission of other reports on official controls that the competent authorities are required to submit to the Commission in accordance with the rules referred to in Article 1(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 114
Annual reports by the Commission
1.

By 31 January every year, the Commission shall make available to the public an annual report on the operation of official controls in the Member States, taking into account:

  • (a) the annual reports submitted by the Member States in accordance with Article 113; and
  • (b) the results of Commission controls performed in accordance with Article 116(1).
2.

The annual report provided for in paragraph 1 may, where appropriate, include recommendations on possible improvements to official control systems in Member States and to certain official controls in certain areas.

Article 115
Contingency plans for food and feed
1.

For the application of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002, Member States shall draw up contingency plans for food and feed setting out measures to be applied without delay when food or feed is found to pose a serious risk to human or animal health either directly or through the environment.

2.

The contingency plans for food and feed provided for in paragraph 1 shall specify:

  • (a) the competent authorities to be involved;
  • (b) the powers and responsibilities of the authorities referred to in point (a); and
  • (c) channels and procedures for sharing information between competent authorities and other parties concerned as appropriate.
3.

Member States shall review regularly their contingency plans for food and feed to take into account changes in the organisation of the competent authorities and experience gained from implementing the plan and simulation exercises.

4.

The Commission may adopt implementing acts concerning:

  • (a) rules for the establishment of the contingency plans provided for in paragraph 1 of this Article to the extent necessary to ensure the consistent and effective use of the general plan for crisis management provided for in Article 55(1) of Regulation (EC) No 178/2002; and
  • (b) the role of stakeholders in the establishment and operation of those contingency plans.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

TITLE VI UNION ACTIVITIES

CHAPTER I Commission controls

Article 116
Commission controls in Member States
1.

Commission experts shall perform controls, including audits, in each Member State to:

  • (a) verify the application of the rules referred to in Article 1(2) and those provided for in this Regulation;
  • (b) verify the functioning of national control systems in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation, and of the competent authorities which operate them;
  • (c) investigate and collect information:
  • (i) on official controls and enforcement practices in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation;
  • (ii) on important or recurring problems with the application or enforcement of the rules referred to in Article 1(2);
  • (iii) in relation to emergency situations, emerging problems or new developments in the Member States in the areas governed by the rules referred to in Article 1(2) and those provided for in this Regulation.
2.

The controls provided for in paragraph 1 shall be organised in cooperation with the competent authorities of the Member States and shall be performed on a regular basis.

3.

The controls provided for in paragraph 1 may include on-the-spot verifications. The Commission experts may accompany the staff of the competent authorities performing official controls.

4.

Experts from the Member States may assist the Commission experts. National experts accompanying Commission experts shall be given the same rights of access as the Commission experts.

Article 117
Reports by the Commission on controls in Member States

The Commission shall:

  • (a) prepare a draft report on the findings and on recommendations addressing the shortcomings identified by its experts during controls performed in accordance with Article 116(1);
  • (b) send to the Member State where those controls have been performed a copy of the draft report provided for in point (a) for its comments;
  • (c) take the comments of the Member State referred to in point (b) into account in preparing the final report on the findings of the controls performed by its experts in the Member States as provided for in Article 116(1); and
  • (d) make publicly available the final report referred to in point (c) and the comments of the Member State referred to in point (b).
Article 118
Programme of the Commission controls in Member States
1.

The Commission shall, by means of implementing acts:

  • (a) establish an annual or multiannual control programme for the controls to be performed by its experts in the Member States as provided for in Article 116(1); and
  • (b) by the end of each year, communicate to the Member States the annual control programme or any update to the multiannual control programme for the following year.
2.

The Commission may, by means of implementing acts, amend its control programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated without delay to the Member States.

Article 119
Obligations of the Member States as regards Commission controls

Member States shall:

  • (a) take appropriate follow-up measures to remedy any specific or systemic shortcomings identified through the controls performed by the Commission experts in accordance with Article 116(1);
  • (b) give the necessary technical assistance and provide the available documentation, including the results of the audits referred to in Article 6, upon justified request, and other technical support that Commission experts request to enable them to perform controls efficiently and effectively; and
  • (c) give the necessary assistance to ensure that the Commission experts have access to all premises or parts of premises, animals and goods, and to information, including computing systems, relevant for the execution of their duties.
Article 120
Commission controls in third countries
1.

Commission experts may perform controls in third countries in order to:

  • (a) verify the compliance or equivalence of third-country legislation and systems, including official certification and the issuance of official certificates, official labels, official marks and other official attestations, with the requirements laid down in the rules referred to in Article 1(2);
  • (b) verify the capacity of the third country control system to ensure that consignments of animals and goods exported to the Union comply with relevant requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;
  • (c) collect information and data to elucidate the causes of recurring or emerging problems in relation to exports of animals and goods from a third country.
2.

The controls provided for in paragraph 1 shall have particular regard to:

  • (a) the legislation of the third country;
  • (b) the organisation of the third country’s competent authorities, their powers and independence, the supervision to which they are subject and the authority they have to enforce the applicable legislation effectively;
  • (c) the training of staff of the competent authority of the third country in the performance of official controls;
  • (d) the resources including analytical, testing and diagnostic facilities available to competent authorities;
  • (e) the existence and operation of documented control procedures and control systems based on priorities;
  • (f) where applicable, the situation regarding animal health, animal welfare, zoonoses and plant health, and procedures for notifying the Commission and relevant international bodies of outbreaks of animal diseases and pests of plants;
  • (g) the extent and operation of controls performed by the competent authority of the third country on animals, plants and their products arriving from other third countries; and
  • (h) the assurances which the third country can give regarding compliance with, or equivalence to, the requirements laid down in the rules referred to in Article 1(2).
3.

In order to facilitate the efficiency and effectiveness of the controls provided for in paragraph 1, the Commission may, prior to performing such controls, request that the third country concerned provide:

  • (a) the necessary information referred to in Article 125(1); and
  • (b) where appropriate and necessary, the written records on the controls its competent authorities perform.
4.

The Commission may appoint experts from Member States to assist its own experts during the controls provided for in paragraph 1.

Article 121
Frequency of Commission controls in third countries

The frequency of Commission controls in third countries referred to in Article 120 shall be determined on the basis of the following criteria:

  • (a) a risk assessment of the animals and goods exported to the Union from the third country concerned;
  • (b) the rules referred to in Article 1(2);
  • (c) the volume and nature of animals and goods entering the Union from the third country concerned;
  • (d) the outcome of controls already performed by the Commission experts or by other inspection bodies;
  • (e) the outcome of official controls on animals and goods entering the Union from the third country concerned and of any other official controls that competent authorities of Member States have performed;
  • (f) information received from the EFSA or similar bodies;
  • (g) information received from internationally recognised bodies such as:
  • (i) the World Health Organization;
  • (ii) the Codex Alimentarius Commission;
  • (iii) the World Organization for Animal Health (OIE);
  • (iv) European and Mediterranean Plant Protection Organization and any other regional plant protection organisations established under the International Plant Protection Convention (IPPC);
  • (v) the secretariat of the IPPC;
  • (vi) Organisation for Economic Co-operation and Development;
  • (vii) United Nations Economic Commission for Europe;
  • (viii) the secretariat of the Cartagena Protocol on Biosafety to the Convention on Biological Biodiversity;
  • (h) evidence of emerging disease situations or other circumstances that might result in animals and goods entering the Union from a third country presenting health or environmental risks or a risk of fraudulent or deceptive practices;
  • (i) the need to investigate or respond to emergency situations in individual third countries.
Article 122
Reports by the Commission on controls in third countries

The Commission shall report on the findings of each control performed in accordance with Articles 120 and 121. Its report shall, where appropriate, contain recommendations.

The Commission shall make its reports publicly available.

Article 123
Programme of the Commission controls in third countries

The Commission shall communicate its programme of controls in third countries to Member States in advance and shall report on the results. The Commission may amend that programme to take account of developments in the areas governed by the rules referred to in Article 1(2). Any such amendment shall be communicated to the Member States in advance.

Article 124
Third-country controls in Member States
1.

Member States shall inform the Commission of planned controls in the areas governed by the rules referred to in Article 1(2) on their territory, by the competent authorities of third countries.

2.

Commission experts may participate in the controls referred to in paragraph 1, at the request of the competent authorities of Member States where those controls are being performed.

3.

The participation by Commission experts in the controls referred to in paragraph 1 shall serve in particular to:

  • (a) provide advice on the rules referred to in Article 1(2);
  • (b) provide information and data available at Union level that may be useful for the control performed by the competent authorities of the third country;
  • (c) facilitate consistency and uniformity with regard to controls performed by the competent authorities of third countries in different Member States.

CHAPTER II Conditions for the entry into the Union of animals and goods

Article 125
Information on third countries' control systems
1.

The Commission shall request third countries which intend to export animals and goods to the Union to provide the following accurate and up-to-date information on the general organisation and management of sanitary and phytosanitary control systems in their territory:

  • (a) any sanitary or phytosanitary rules adopted or proposed within their territory;
  • (b) risk-assessment procedures and factors taken into consideration for the assessment of risks and for the determination of the appropriate level of sanitary or phytosanitary protection;
  • (c) any control and inspection procedures and mechanisms, including, where relevant, on animals or goods arriving from other third countries;
  • (d) official certification mechanisms;
  • (e) where appropriate, any measures taken following recommendations provided for in the first paragraph of Article 122;
  • (f) where relevant, results of controls performed on animals and goods intended to be exported to the Union; and
  • (g) where relevant, information on changes made to the structure and functioning of control systems adopted to meet Union sanitary or phytosanitary requirements or recommendations provided for in the first paragraph of Article 122.
2.

The request for information referred to in paragraph 1 shall be proportionate, taking account of the nature of the animals and goods to be exported to the Union and of the specific situation in, and structure of, the third country.

Article 126
Establishment of additional conditions for entry into the Union of animals and goods
1.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions to be respected by animals and goods entering the Union from third countries which are necessary to ensure that the animals and goods comply with the relevant requirements established by the rules referred to in Article 1(2), with the exception of points (d), (e), (g) and (h) of Article 1(2), or with requirements recognised to be at least equivalent thereto.

2.

The conditions laid down in the delegated acts referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature and may include:

  • (a) the requirement that certain animals and goods shall only enter the Union from a third country or region of a third country which appears on a list drawn up by the Commission for that purpose;
  • (b) the requirement that consignments of certain animals and goods from third countries be dispatched from, and obtained or prepared in, establishments which comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto;
  • (c) the requirement that consignments of certain animals and goods be accompanied by an official certificate, an official attestation, or by any other evidence that the consignments comply with the relevant requirements referred to in paragraph 1 or with requirements recognised to be at least equivalent thereto, including the results of the analysis performed by an accredited laboratory;
  • (d) the obligation to provide the evidence referred to in point (c) in accordance with a specific format;
  • (e) any other requirement necessary to ensure that certain animals and goods offer a level of protection of health and, as regards GMOs, also of the environment, equivalent to that ensured by the requirements referred to in paragraph 1.
3.

The Commission may, by means of implementing acts, lay down rules on the format and type of official certificates, official attestations, or evidence required in accordance with the rules provided for in point (c) of paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 127
Inclusion in the list of third countries referred to in point (a) of Article 126(2)
1.

The inclusion of a third country or region thereof in the list referred to in point (a) of Article 126(2) shall be made in accordance with paragraphs 2 and 3 of this Article.

2.

The Commission shall approve, by means of implementing acts, the request transmitted to it for the purpose referred to in paragraph 1 of this Article by the third country concerned, accompanied by appropriate evidence and guarantees that the animals and goods concerned from that third country comply with the relevant requirements referred to in Article 126(1) or with requirements equivalent thereto. Those implementing acts shall be adopted and updated in accordance with the examination procedure referred to in Article 145(2).

3.

The Commission shall decide on the request referred to in paragraph 2 taking into account, as appropriate:

  • (a) the third country’s legislation in the sector concerned;
  • (b) the structure and organisation of the competent authorities of the third country and its control services, the powers available to them, the guarantees that can be provided with regard to the application and enforcement of the legislation of the third country applicable to the sector concerned, and the reliability of the official certification procedures;
  • (c) the performance by the competent authorities of the third country of adequate official controls and other activities to assess the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;
  • (d) the regularity and rapidity of information supplied by the third country on the presence of hazards for human, animal or plant health, for animal welfare or, in relation to GMOs and plant protection products, also for the environment;
  • (e) the guarantees given by the third country that:
  • (i) conditions applied to the establishments from which animals or goods are exported to the Union comply with requirements that are equivalent to those referred to in Article 126(1);
  • (ii) a list of the establishments referred to in point (i) is drawn up and kept up to date;
  • (iii) the list of establishments referred to in point (i) and updates thereof are communicated to the Commission without delay;
  • (iv) the establishments referred to in point (i) are the subject of regular and effective controls by the competent authorities of the third country;
  • (f) the findings of controls performed by the Commission in the third country in accordance with Article 120(1);
  • (g) any other information or data on the capability of the third country to ensure that only animals or goods which provide the same or an equivalent level of protection as that afforded by the relevant requirements referred to in Article 126(1) enter the Union.
4.

The Commission shall delete the reference to a third country or a region of a third country from the list referred to in point (a) of Article 126(2) where the conditions for inclusion on the list cease to be met. The procedure referred to in paragraph 2 of this Article shall apply.

Article 128
Special measures regarding the entry into the Union of certain animals and goods
1.

Where, in cases other than those referred to in Article 53 of Regulation (EC) No 178/2002 and Article 249 of Regulation (EU) 2016/429, there is evidence that the entry into the Union of certain animals or goods originating from a third country, a region thereof or a group of third countries, pose a risk to human, animal or plant health or, as regards GMOs, also to the environment, or where there is evidence that widespread serious non-compliance with the rules referred to in Article 1(2) of this Regulation is taking place, the Commission shall adopt, by means of implementing acts, the measures necessary to contain such risk or put an end to the identified non-compliance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2) of this Regulation.

2.

The measures referred to in paragraph 1 shall identify animals and goods by referring to their codes from the Combined Nomenclature, and may include:

  • (a) the prohibition of entry into the Union of the animals and goods referred to in paragraph 1 originating in or dispatched from the third countries concerned or regions thereof;
  • (b) the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, prior to dispatch, to specific treatment or controls;
  • (c) the requirement that the animals and goods referred to in paragraph 1 originating in or dispatched from certain third countries or regions thereof be subject, upon entry into the Union, to specific treatment or controls;
  • (d) the requirement that consignments of the animals and goods referred to in paragraph 1 of this Article originating in or dispatched from certain third countries or regions thereof, be accompanied by an official certificate, an official attestation, or by any other evidence that the consignment complies with requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto;
  • (e) the requirement that the evidence referred to in point (d) be provided in accordance with a specific format;
  • (f) other measures necessary to contain the risk.
3.

When adopting the measures referred to in paragraph 2, account shall be taken of:

  • (a) the information collected in accordance with Article 125;
  • (b) any other information that the third countries concerned have provided; and
  • (c) where necessary, the results of Commission controls provided for in Article 120(1).
4.

On duly justified imperative grounds of urgency relating to human health and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).

Article 129
Equivalence
1.

In the areas governed by the rules referred to in Article 1(2), with the exclusion of points (d), (e), (g), and (h) of Article 1(2), the Commission may, by means of implementing acts, recognise that measures applied in a third country, or regions thereof, are equivalent to the requirements laid down in those rules, on the basis of:

  • (a) a thorough examination of information and data provided by the third country concerned pursuant to Article 125(1); and
  • (b) where appropriate, the satisfactory outcome of a control performed in accordance with Article 120(1).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2.

The implementing acts referred to in paragraph 1 shall set out the practical arrangements for the entry of animals and goods into the Union from the third country concerned, or regions thereof, and may include:

  • (a) the nature and content of the official certificates or attestations that have to accompany the animals or goods;
  • (b) specific requirements applicable to the entry into the Union of the animals or goods and the official controls to be performed at entry into the Union;
  • (c) where necessary, procedures for drawing up and amending lists of regions or establishments in the third country concerned from which the entry of animals and goods into the Union is permitted.
3.

The Commission shall, by means of implementing acts, repeal without delay the implementing acts provided for in paragraph 1 of this Article where any of the conditions for the recognition of equivalence cease to be fulfilled. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

CHAPTER III Training of staff of the competent authorities and of other authorities

Article 130
Training and exchange of staff
1.

The Commission may organise training activities for the staff of the competent authorities and, where appropriate, for staff of other authorities of the Member States involved in investigations of possible infringements of this Regulation and of the rules referred to in Article 1(2).

The Commission shall organise those activities in cooperation with the Member States concerned.

2.

The training activities referred to in paragraph 1 shall facilitate the development of a harmonised approach to official controls and other official activities in Member States. They shall include, as appropriate, training on:

  • (a) this Regulation and the rules referred to in Article 1(2);
  • (b) control methods and techniques relevant for the official controls and for the other official activities of the competent authorities;
  • (c) production, processing and marketing methods and techniques.
3.

The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union.

4.

Competent authorities shall ensure that the knowledge acquired through the training activities referred to in paragraph 1 of this Article is disseminated as necessary and appropriately used in the staff training activities referred to in Article 5(4).

Training activities aimed at disseminating such knowledge shall be included in the training programmes referred to in Article 5(4).

5.

The Commission may organise, in cooperation with the Member States, programmes for the exchange of staff of the competent authorities performing official controls or other official activities between two or more Member States.

Such exchange may take place through the temporary secondment of staff of the competent authorities from one Member State to the other or through the exchange of such staff between the relevant competent authorities.

6.

The Commission may, by means of implementing acts, lay down rules on the organisation of the training activities referred to in paragraph 1, and of the programmes referred to in paragraph 5, of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

CHAPTER IV Information management system

Article 131
Information management system for official controls (IMSOC)
1.

The Commission shall, in collaboration with the Member States, set up and manage a computerised information management system for official controls (IMSOC) for the integrated operation of the mechanisms and tools through which data, information and documents concerning official controls and other official activities are managed, handled, and automatically exchanged.

2.

The processing of personal data by the Member States and the Commission through the IMSOC and any one of its components shall only be carried out for the purpose of performing official controls and other official activities in accordance with this Regulation and with the rules referred to in Article 1(2).

Article 132
General functionalities of the IMSOC

The IMSOC shall:

  • (a) allow for the computerised handling and exchange of information, data and documents necessary for the performance of official controls, resulting from the performance of official controls or the recording of the performance or outcome of official controls in all cases where this Regulation, the rules referred to in Article 1(2) or the delegated and implementing acts provided for in Articles 16 to 27 provide for the exchange among competent authorities, between the competent authorities and the Commission, and where appropriate with other authorities and the operators, of such information, data and documents;
  • (b) provide a mechanism for the exchange of data, information and documents in accordance with Articles 102 to 108;
  • (c) provide a tool to collect and manage the reports on official controls provided by Member States to the Commission;
  • (d) allow for the production, handling and transmission, including in electronic form, of the journey log referred to in Article 5(4) of Regulation (EC) No 1/2005, of the records obtained by the navigation system referred to in Article 6(9) of that Regulation, of official certificates and of the CHED referred to in Article 56 of this Regulation; and
  • (e) integrate the existing computerised systems managed by the Commission and used for the rapid exchange of data, information and documents in relation to risks to human, animal health and welfare, and plant health, as established by Article 50 of Regulation (EC) No 178/2002, Article 20 of Regulation (EU) 2016/429 and Article 103 of Regulation (EU) 2016/2031 and provide appropriate links between those systems and its other components.
Article 133
Use of the IMSOC in the case of animals and goods subject to certain official controls
1.

In the case of animals or goods whose movements within the Union or placing on the market are subject to specific requirements or procedures established by the rules referred to in Article 1(2), the IMSOC shall enable the competent authorities at the place of dispatch and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning animals or goods being moved from one Member State to another and on official controls performed.

The first subparagraph of this paragraph shall not apply to goods subject to the rules referred to in points (g) and (h) of Article 1(2).

2.

In the case of exported animals and goods for which Union rules apply in relation to the issuance of the export certificate, the IMSOC shall enable the competent authorities of the place of dispatch and other competent authorities responsible for performing official controls to exchange, in real time, data, information and documents concerning such animals and goods and the outcome of controls performed on those animals and goods.

3.

In the case of animals or goods subject to the official controls referred to in Articles 44 to 64, the IMSOC shall:

  • (a) enable the competent authorities at the border control posts and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning those animals and goods and on controls performed on those animals or goods;
  • (b) enable the competent authorities at the border control posts to share and exchange relevant data, information and documents with customs authorities and other authorities responsible for performing controls on animals or goods entering the Union from third countries, and with operators involved in entry procedures, in accordance with the rules adopted pursuant to Articles 15(4) and 75(2) and with other relevant Union rules; and
  • (c) support and operate the procedures referred to in point (a) of Article 54(3) and in Article 65(6).
4.

The IMSOC shall, for the purpose of this Article, integrate the existing Traces system.

Article 134
The functioning of the IMSOC

The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down:

  • (a) the technical specifications of the IMSOC and its system components, including the electronic data exchange mechanism for exchanges with existing national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures;
  • (b) the specific rules for the functioning of the IMSOC and of its system components to ensure protection of personal data and security of exchange of information;
  • (c) the specific rules for the functioning and use of the IMSOC and of its components, including the rules to update and create the necessary links between the systems referred to in point (e) of Article 132 and in Article 133(4);
  • (d) contingency arrangements to be applied in the event of unavailability of any of the functionalities of the IMSOC;
  • (e) the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the IMSOC and the practical arrangements of such access;
  • (f) the cases where, and the conditions under which, the data, information and documents are to be transmitted using the IMSOC;
  • (g) the rules concerning an electronic system under which electronic certificates issued by the competent authorities of third countries are to be accepted by the competent authorities; and
  • (h) the cases where, and the conditions under which, exemptions from the use of the IMSOC can be granted to occasional users.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

Article 135
Data protection
1.

Directive 95/46/EC and Regulation (EC) No 45/2001 of the European Parliament and of the Council ([^E0017]) shall apply to the extent that the information processed through the IMSOC contains personal data as defined in point (a) of Article 2 of Directive 95/46/EC and in point (a) of Article 2 of Regulation (EC) No 45/2001.

2.

In relation to their responsibilities to transmit the relevant information to the IMSOC and the processing of any personal data that might result from that activity, the competent authorities of the Member States shall be regarded as controllers as defined in point (d) of Article 2 of Directive 95/46/EC.

3.

In relation to its responsibility to manage the IMSOC and the processing of any personal data that might result from that activity, the Commission shall be regarded as controller as defined in point (d) of Article 2 of Regulation (EC) No 45/2001.

4.

Member States may restrict the rights and obligations under Article 6(1), Article 10, Article 11(1) and Article 12 of Directive 95/46/EC as necessary to safeguard the interest referred to in points (d) and (f) of Article 13(1) of that Directive.

5.

The Commission may restrict the rights and obligations under Article 4(1), Article 11, Article 12(1) and Articles 13 to 17 of Regulation (EC) No 45/2001 where such restriction constitutes a necessary measure to safeguard the interests referred to in points (a) and (e) of Article 20(1) of that Regulation during the period in which actions are being planned or performed to verify compliance with food or feed law or to ensure the enforcement of food or feed law in the specific case to which the information relates.

Article 136
Data security

Member States and the Commission shall ensure that the IMSOC complies with the rules on data security adopted by the Commission under Article 17 of Directive 95/46/EC and Article 22 of Regulation (EC) No 45/2001 respectively.

TITLE VII ENFORCEMENT ACTION

CHAPTER I Actions by the competent authorities and penalties

Article 137
General obligations of the competent authorities as regards enforcement action
1.

When acting in accordance with this Chapter, the competent authorities shall give priority to action to be taken to eliminate or contain risks to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment.

2.

In case of suspicion of non-compliance, the competent authorities shall perform an investigation in order to confirm or to eliminate that suspicion.

3.

Where necessary, actions taken in accordance with paragraph 2 shall include:

  • (a) the performance of intensified official controls on animals, goods and operators for an appropriate period;
  • (b) the official detention of animals and goods and of any unauthorised substances or products as appropriate.
Article 138
Actions in the event of established non-compliance
1.

Where the non-compliance is established, the competent authorities shall take:

  • (a) any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and
  • (b) appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance.

When deciding which measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance.

2.

When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following:

  • (a) order or perform treatments on animals;
  • (b) order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals, and, if necessary, order that veterinary assistance be sought;
  • (c) order treatments on goods, the alteration of labels or corrective information to be provided to consumers;
  • (d) restrict or prohibit the placing on the market, the movement, the entry into the Union or the export of animals and goods; and prohibit their return to the Member State of dispatch or order their return to the Member State of dispatch;
  • (e) order the operator to increase the frequency of own controls;
  • (f) order certain activities of the operator concerned to be subject to increased or systematic official controls;
  • (g) order the recall, withdrawal, removal and destruction of goods, authorising, where appropriate, the use of the goods for purposes other than those for which they were originally intended;
  • (h) order the isolation or closure, for an appropriate period of time, of all or part of the business of the operator concerned, or its establishments, holdings or other premises;
  • (i) order the cessation for an appropriate period of time of all or part of the activities of the operator concerned and, where relevant, of the internet sites it operates or employs;
  • (j) order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver;
  • (k) order the slaughter or killing of animals provided that this is the most appropriate measure to safeguard human health as well as animal health and welfare.
3.

The competent authorities shall provide the operator concerned, or its representative, with:

  • (a) written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and
  • (b) information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal.
4.

All expenditure incurred under this Article shall be borne by the responsible operators.

5.

The competent authorities, in the case of issuance of false or misleading official certificates or in the case of abuse of official certificates, shall take appropriate measures, including:

  • (a) the temporary suspension of the certifying officer from its duties;
  • (b) the withdrawal of the authorisation to sign official certificates;
  • (c) any other measure to prevent a reoccurrence of the offences referred to in Article 89(2).
Article 139
Penalties
1.

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 14 December 2019, notify those provisions to the Commission and shall notify it without delay of any subsequent amendment affecting them.

2.

Member States shall ensure that financial penalties for violations of this Regulation and of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, reflect, in accordance with national law, at least either the economic advantage for the operator or, as appropriate, a percentage of the operator's turnover.

Article 140
Reporting of infringements
1.

Member States shall ensure that competent authorities have effective mechanisms to enable reporting of actual or potential infringements of this Regulation.

2.

The mechanisms referred to in paragraph 1 shall include at least:

  • (a) procedures for the receipt of reports of infringements and their follow-up;
  • (b) appropriate protection for persons reporting an infringement against retaliation, discrimination or other types of unfair treatment; and
  • (c) protection of personal data of the person reporting an infringement in accordance with Union and national law.

CHAPTER II Union enforcement measures

Article 141
Serious disruption in a Member State's control system
1.

Where the Commission has evidence of a serious disruption in a Member State’s control system and such disruption may constitute a widespread risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or result in a widespread infringement of the rules referred to in Article 1(2), it shall, by means of implementing acts, adopt one or more of the following measures, to be applied until such disruption is eliminated:

  • (a) the prohibition to make available on the market or to transport, move or otherwise handle certain animals or goods concerned by the disruption in the control system;
  • (b) special conditions for the activities, animals or goods referred to in point (a);
  • (c) the suspension of the operation of official controls in border control posts or other control points concerned by the disruption in the official control system or the withdrawal of such border control posts or other control points;
  • (d) other appropriate temporary measures necessary to contain that risk until the disruption in the control system is eliminated.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).

2.

The measures referred to in paragraph 1 shall be adopted only where the Member State concerned has not corrected the situation upon request and within the appropriate time limit set by the Commission.

3.

On duly justified imperative grounds of urgency relating to human and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).

TITLE VIII COMMON PROVISIONS

CHAPTER I Procedural provisions

Article 142
Amendment of Annexes and references to European standards
1.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning amendments to Annexes II and III, in order to take into account changes to the rules referred to in Article 1(2), technical progress and scientific developments.

2.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the references to the European standards referred to in point (b)(iv) of Article 29, point (e) of Article 37(4) and point (a) of Article 93(3), in the event that CEN amends those standards.

Article 143
Data protection
1.

Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation.

2.

Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.

Article 144
Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.

The power to adopt delegated acts referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall be conferred on the Commission for a period of five years from 28 April 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.

The delegation of power referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.

Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.

A delegated act adopted pursuant to Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 145
Committee procedure
1.

The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002, except in respect of Articles 25 and 26 of this Regulation for which the Commission shall be assisted respectively by the committees established pursuant to Regulation (EC) No 834/2007 and to Regulation (EU) No 1151/2012. Those committees shall be committees within the meaning of Regulation (EU) No 182/2011.

2.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

3.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

CHAPTER II Transitional and final provisions

Article 146
Repeals
1.

Regulations (EC) No 854/2004 and (EC) No 882/2004, Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Decision 92/438/EEC, are repealed with effect from 14 December 2019.

2.

References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex V.

Article 147
Relation with Regulation (EC) No 882/2004

The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall remain effective until a designation of a European Union reference laboratory in the same area takes place in accordance with Article 93 of this Regulation.

Article 148
Relation with Regulations (EC) No 852/2004 and (EC) No 853/2004 regarding approval of food business establishments
1.

Competent authorities shall establish procedures for food business operators to follow when applying for the approval of their establishments in accordance with Regulations (EC) No 852/2004 and (EC) No 853/2004.

2.

Upon receipt of an application for approval from a food business operator, the competent authority shall make an on-site visit.

3.

The competent authority shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it complies with the relevant requirements of food law.

4.

The competent authority may grant conditional approval if it appears that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new official control of the establishment, carried out within three months of granting conditional approval, that the establishment meets the other relevant requirements of food law. If clear progress has been made but the establishment still does not meet all of the relevant requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not exceed a total of six months, except in the case of factory and freezer vessels flying the flag of Member States, for which such conditional approval shall not exceed a total of 12 months.

5.

The competent authority shall keep the approval of establishments under review when carrying out official controls.

Article 149
1.

The relevant provisions of Directives 91/496/EEC and 97/78/EC which govern matters referred to in point (b) of Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58 of this Regulation shall apply instead of the corresponding provisions of this Regulation until 13 December 2019.

The relevant provisions of Directive 97/78/EC which govern matters referred to in point (a) of Article 47(2) of this Regulation related to composite products shall continue to apply instead of that corresponding provision until 20 April 2021.

2.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 1 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 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58.

Article 150
1.

Competent authorities shall continue to perform the official controls necessary to detect the presence of the substances and groups of residues listed in Annex I to Directive 96/23/EC, in accordance with Annexes II, III and IV to that Directive, 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.

2.

Article 29(1) and (2) of Directive 96/23/EC 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.

3.

The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the earlier date referred to in paragraphs 1 and 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 Articles 19 and 112.

Article 151
Amendments to Directive 98/58/EC

Directive 98/58/EC is amended as follows:

  • (1) Article 2, point (3) is replaced by the following:
  • ‘3. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation  (EU) 2017/625 of the European Parliament and of the Council ([^E0018])
  • (2) Article 6 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.’;
  • (c) in paragraph 3, point (a) is deleted;
  • (3) Article 7 is deleted.
Article 152
Amendments to Directive 1999/74/EC

Directive 1999/74/EC is amended as follows:

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