Regulation (EU) 2016/1012 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER X Official controls and other official activities, administrative assistance, cooperation and enforcement by Member States

Article 39 Designation of competent authorities

1. Member States shall designate the competent authorities with the responsibility for performing official controls for the verification of compliance of operators with the rules provided for in this Regulation, and for performing other official activities to ensure the application of those rules.

2. Each Member State shall:

(a) draw up and keep up to date a list of the competent authorities it has designated in accordance with paragraph 1, including their contact details;

(b) specify in the list provided for in point (a) the address to which the following is to be sent:

(i)

the notifications referred to in Article 12; or

(ii)

the information, requests or notifications referred to in Articles 48 and 49;

(c) make the list referred to in point (a) available to the public on a website and notify that website to the Commission.

3. The Commission shall draw up and keep up to date a list of the websites referred to in point (c) of paragraph 2 and make such list available to the public.

Article 40 Compliance by competent authorities carrying out breeding programmes

By way of derogation from this Chapter, Member States shall take the necessary measures to verify that competent authorities carrying out breeding programmes in accordance with Article 38 comply with the rules laid down in that Article.

Article 41 General obligations of competent authorities

Competent authorities shall:

(a)

have procedures or arrangements, or both, in place to ensure and verify the effectiveness, appropriateness, impartiality, quality and consistency of the official controls and of the other official activities that they perform;

(b)

have procedures or arrangements, or both, in place to ensure that their staff performing official controls and other official activities are free from any conflict of interest as regards the operators in respect of which they perform those official controls and other official activities;

(c)

have, or have access to, a sufficient number of suitably qualified, trained and experienced staff so that official controls and other official activities can be performed efficiently and effectively;

(d)

have appropriate and properly maintained facilities and equipment to ensure that their staff can perform official controls and other official activities efficiently and effectively;

(e)

have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation;

(f)

have legal procedures in place in order to ensure that their staff have access to the premises of, and documents and computerised information management systems kept by, operators so as to be able to carry out their tasks properly.

Article 42 Confidentiality obligations of the competent authorities

1. Without prejudice to situations where its disclosure is required by Union law or national law, competent authorities shall require members of their staff to undertake not to disclose to third parties information acquired when undertaking their duties, in the context of official controls and other official activities, which is, by its nature, covered by professional confidentiality, unless there is an overriding public interest in its disclosure.

2. Information covered by professional confidentiality shall include information the disclosure of which would undermine:

(a) the purpose of official controls or investigations;

(b) the protection of commercial interests of an operator or any other natural or legal person;

(c) the protection of court proceedings and legal advice.

Article 43 Rules on official controls

1. Competent authorities shall perform official controls on operators with appropriate frequency, taking account of:

(a) the risk of non-compliance with the rules provided for in this Regulation;

(b) the past records of operators as regards the results of official controls performed in their respect and their compliance with the rules provided for in this Regulation;

(c) the reliability and results of self-checks performed by the operators, or by third parties at their request, for the purpose of verifying compliance with the rules provided for in this Regulation;

(d) any information that might indicate non-compliance with the rules provided for in this Regulation.

2. Competent authorities shall perform official controls in accordance with documented procedures, which shall contain instructions for staff performing official controls.

3. Official controls shall be performed after the operator has been notified in advance unless there are reasons to carry out the official controls without prior notice.

4. Official controls shall, as far as possible, be performed in a manner that minimises the burden on the operators without this negatively affecting the quality of those official controls.

5. Competent authorities shall perform official controls in the same manner irrespective of whether the breeding animals or the germinal products thereof:

(a) originate in the Member State where the official controls are performed or in another Member State; or

(b) are entering the Union.

Article 44 Transparency of official controls

The competent authority shall perform official controls with a high level of transparency and shall make relevant information concerning the organisation and the performance of official controls publicly available.

Article 45 Written records of official controls

1. Competent authorities shall draw up written records of every official control that they perform.

Those written records shall contain:

(a) a description of the purpose of the official control;

(b) the control methods applied;

(c) the results of the official control;

(d) where appropriate, action that the competent authorities require the operators to take as a result of the official control.

2. Unless the purposes of judicial investigations or the protection of court proceedings require otherwise, competent authorities shall provide the operators which have been subject to an official control with a copy of the written records referred to in paragraph 1.

Article 46 Obligations of operators subject to official controls or other official activities

1. To the extent that this is necessary for the performance of official controls or other official activities, operators shall, when required to do so by the competent authorities, give to the staff of those competent authorities the necessary access to:

(a) their equipment, premises and other places under their control;

(b) their computerised information management systems;

(c) their breeding animals and the germinal products thereof under their control;

(d) their documents and any other relevant information.

2. During official controls and other official activities, operators shall assist and cooperate with the staff of the competent authorities in the accomplishment of their tasks.

Article 47 Actions in case of established non-compliance

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

(a) take any action necessary to determine the origin and extent of that non-compliance and to establish the responsibilities of the operators concerned;

(b) take appropriate measures to ensure that the operators concerned remedy the non-compliance and prevent further occurrences of it.

When deciding which measures to take, the competent authorities shall take account of the nature of the non-compliance and the past record of the operators concerned with regard to compliance.

In particular competent authorities shall, as appropriate:

(a) order that the breed society postpones the entry in breeding books of purebred breeding animals or that the breeding operation postpones the registration in breeding registers of hybrid breeding pigs;

(b) order that the breeding animals or their germinal products shall not be used for breeding in accordance with this Regulation;

(c) suspend the issuing of zootechnical certificates by the breed society or the breeding operation;

(d) suspend or withdraw the approval of a breeding programme carried out by a breed society or breeding operation, where the activities of that breed society or breeding operation repeatedly, continuously or generally fail to comply with the requirements of the breeding programme approved in accordance with Article 8(3), and, where applicable, Article 12;

(e) withdraw the recognition of the breed society or breeding operation granted in accordance with Article 4(3), where that breed society or breeding operation repeatedly, continuously or generally fails to comply with the requirements referred to in Article 4(3);

(f) take any other measures that they deem to be appropriate to ensure compliance with the rules provided for in this Regulation.

2. The competent authorities shall provide the operators concerned, or their representatives, with:

(a) a written notification of their decision concerning the action or measure to be taken in accordance with paragraph 1, together with the reasons for that decision;

(b) information on any right of appeal against such decisions, and on the applicable procedure and time limits.

3. The competent authorities shall monitor the situation and shall modify, suspend or withdraw the measures that they have taken in accordance with this Article, depending on the severity of the non-compliance and the existence of clear evidence of a return to compliance.

4. Member States may provide that the operators concerned are to bear all or part of expenditure incurred pursuant to this Article by competent authorities concerned.

Article 48 Cooperation and administrative assistance

1. Where non-compliance originates in, spreads to or affects more than one Member State, the competent authorities in those Member States shall cooperate with one another as well as provide one another with administrative assistance in order to ensure the correct application of the rules provided for in this Regulation.

2. The cooperation and administrative assistance provided for in paragraph 1 may include:

(a) the reasoned request by a competent authority of a Member State (‘requesting competent authority’) for information from a competent authority of another Member State (‘requested competent authority’) that is needed in order to perform official controls or to follow them up;

(b) in the case of a non-compliance which might have implications in other Member States, the notification of the competent authorities of those other Member States by the competent authority aware of the non-compliance;

(c) the provision, by the requested competent authority, of necessary information and documents to the requesting competent authority, without undue delay when the relevant information and documents become available;

(d) the performance of investigations or official controls by the requested competent authority that are necessary to:

(i)

provide the requesting competent authority with all necessary information and documents, including information concerning the results of such investigations or official controls and, where appropriate, the measures taken;

(ii)

verify, where necessary ‘on-the-spot’, compliance within their jurisdiction with the rules provided for in this Regulation;

(e) by agreement between the competent authorities concerned, participation by a competent authority of a Member State in on-the-spot official controls that the competent authorities of another Member State perform.

3. Where official controls performed on breeding animals or their germinal products originating in another Member State show repeated instances of non-compliance with the rules provided for in this Regulation, the competent authority of the Member State that has performed those official controls shall inform the Commission and the competent authorities of the other Member States thereof without undue delay.

4. This Article shall apply without prejudice to national rules that are:

(a) applicable to the release of documents that are the object of, or related to, judicial proceedings;

(b) aimed at the protection of commercial interests vested in natural or legal persons.

5. All communications between competent authorities in accordance with this Article shall be in writing, either on paper or in electronic form.

Article 49 Notification of the Commission and Member States on the basis of information provided by third countries

1. Where competent authorities receive information from a third country indicating non-compliance with the rules provided for in this Regulation, they shall, without undue delay:

(a) notify such information to the competent authorities of the other Member States known to be concerned by that non-compliance;

(b) where such information is or might be relevant at Union level, communicate such information to the Commission.

2. Information obtained through official controls or 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) relevant Union and national rules applicable to the communication of personal data to third countries are complied with.

Article 50 Coordinated assistance and follow-up by the Commission

1. The Commission shall, without delay, coordinate the measures and actions undertaken by the competent authorities in accordance with this Chapter where:

(a) information available to the Commission indicates the existence of activities that are, or appear to be, non-compliant with the rules provided for in this Regulation and that concern more than one Member State;

(b) the competent authorities in the Member States concerned are unable to agree on appropriate actions to address the non-compliance with the rules provided for in this Regulation.

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

(a) request that the competent authorities of the Member States concerned by the activities that are, or appear to be, non-compliant with the rules provided for in this Regulation, provide it with a report on the measures that they have taken;

(b) in collaboration with the Member States concerned by the activities that are, or appear to be, non-compliant with the rules provided for in this Regulation, send an inspection team to perform an on-the-spot Commission control;

(c) request that the competent authorities of the Member State of dispatch and, where appropriate, in other Member States concerned, appropriately intensify their official controls and provide it with a report on the measures that they have taken;

(d) submit information concerning such cases to the Committee referred to in Article 62(1), together with a proposal for measures to remedy the cases of non-compliance referred to in point (a) of paragraph 1 of this Article;

(e) take any other appropriate measures.

Article 51 General principle for the financing of official controls

Member States shall ensure that adequate financial resources are available so that the competent authorities have the staff and other resources necessary to perform official controls and other official activities.

Article 52 Penalties

Member States shall lay down the penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are applied. Those penalties must be effective, proportionate and dissuasive.

Member States shall notify those provisions to the Commission by 1 November 2018 and shall notify it without delay of any subsequent amendment affecting them.