Where the F1Secretary of State considers that there are grounds to impose a fine and periodic penalty payments on a recognised organisation in accordance with Article 6 of Regulation (EC) No 391/2009, or to withdraw an organisation's recognition in accordance with Article 7 of that Regulation, it shall address a statement of objections to the organisation F2....

When notifying the statement of objections, the F1Secretary of State shall invite the recognised organisation F4... to submit written observations within a designated time limit, which shall not, in any event, be less than six weeks of the date of receipt of the statement of objections. The F1Secretary of State shall not be obliged to take into account submissions received after the expiry of that time limit, without prejudice to the provisions of Article 24 paragraph 4 of this Regulation.

The notification of a statement of objections shall not suspend the assessment of the organisation concerned. At any moment prior to the adoption of a decision to impose a fine and periodic penalty payments, or the withdrawal of recognition in accordance with this Regulation, the F1Secretary of State may decide to carry out additional inspections of an organisation's offices and facilities, to visit ships certified by the organisation or to request the recognised organisation in writing to provide additional information relating to its compliance with the criteria and obligations under Regulation (EC) No 391/2009.

At any moment prior to the adoption of a decision to impose a fine and periodic penalty payments, or the withdrawal of recognition in accordance with this Regulation, the F1Secretary of State may amend its assessment of the recognised organisation concerned. If the new assessment is different to the assessment which gave rise to the statement of objections, because new facts have been discovered, or because new infringements or new circumstances concerning the seriousness of an infringement or its effects on safety and the environment have been identified, the F1Secretary of State shall issue a new statement of objections.

At the request of the recognised organisation to which a statement of objections has been addressed, the F6Secretary of State shall offer that organisation the opportunity to present its arguments at an oral hearing.

F7The Secretary of State may invite any other persons with a legitimate interest in the infringement to take part in the oral hearing.

Natural or private legal persons invited to attend shall either appear in person or be represented by legal or authorised representatives. F8...

The oral hearing shall not be public. Each person invited to attend may be heard separately or in the presence of other persons invited to attend, having regard to the legitimate interest of the recognised organisation and other parties in the protection of their business secrets and other confidential information.

The statements made by each person heard shall be recorded. Upon request, the recording of the hearing shall be made available to the persons who attended the hearing F9....

Where the F10Secretary of State intends to F11make a decision imposing periodic penalty payments as referred to in Article 7(1) to a recognised organisation that has failed to undertake or incurs unjustified delays in undertaking preventive and remedial action requested by the F10Secretary of State, F12the Secretary of State shall first notify the recognised organisation in writing.

The notification by the F10Secretary of State in accordance with paragraph 1 shall make reference to the specific preventive and remedial action that has not been undertaken by the recognised organisation and the supporting evidence, as well as inform the recognised organisation of the periodic penalty payments that are being considered by the F10Secretary of State thereon.

The F10Secretary of State shall set a time limit in which the recognised organisation may submit written observations to the F10Secretary of State. The F10Secretary of State shall not be obliged to take into account written observations received after the expiry of the time limit.

At the request of the recognised organisation to which a statement of objections has been addressed, the F13Secretary of State shall grant access to the file containing documents and other evidence compiled by the F13Secretary of State on the alleged infringement.

The F13Secretary of State shall set the date and make the relevant practical arrangements for the recognised organisation's access to the file, which may be granted in electronic form only.

The F13Secretary of State shall make available to the recognised organisation concerned, upon request, a list of all the documents contained in the file.

The recognised organisation concerned shall have the right to access the documents and information contained in the file. When granting such access, the F13Secretary of State shall have due regard to business secrets, confidential information or the internal character of documents issued by the F13Secretary of StateF14....

F15For the purposes of paragraph 4, internal documents of the Secretary of State may include documents or parts of documents pertaining to the internal deliberations of the Secretary of State.

Proceedings under this Regulation shall be carried out subject to the principles of confidentiality and of professional secrecy.

The F16Secretary of StateF17... shall not disclose information acquired or exchanged F17... pursuant to this Regulation and of the kind covered by the obligation of professional secrecy and confidentiality.

Any recognised organisation or other person who submits information or observations pursuant to this Regulation shall clearly identify any material considered to be confidential, giving the reasons for it, and provide a separate non-confidential version by the date set by the F16Secretary of State.

The F16Secretary of State may also require recognised organisations and other interested parties to identify any part of a report, of the statement of objections or of a decision by the F16Secretary of State, which in their view contains business secrets.

In the absence of the identification referred to in paragraphs 3 and 4, the F16Secretary of State may assume that the documents or observations concerned do not contain confidential information.

Without prejudice to Article 9 of Regulation (EC) No 391/2009, recognised organisations shall have the right to remain silent in situations where it would otherwise be compelled to provide answers which might involve an admission on their part of the existence of a breach.

A decision to impose fines, periodic penalty payments, or the withdrawal of recognition in accordance with this Regulation shall be based exclusively on the grounds on which the recognised organisation concerned has been able to submit its observations.

The decision to impose a fine or a periodic penalty payment and the determination of the appropriate amount shall take into account the principles of effectiveness, proportionality and dissuasiveness.

When taking measures in accordance with this Regulation and deciding on the seriousness and effect of the relevant actions or omissions on safety and the environment the F18Secretary of State shall take into account national measures already taken on the basis of the same facts against the recognised organisation concerned, in particular where that organisation has already been subject to judicial or enforcement proceedings.

Actions or omissions of a recognised organisation on the basis of which measures have been taken in accordance with this Regulation shall not be subject to further measures. However, these actions or omissions may be taken into account in subsequent decisions F19made in accordance with this Regulation in order to assess recurrence.

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The F22Secretary of State shall inform the recognised organisation concerned of the judicial remedies available to it.

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When justified, in particular on grounds of safety or protection of the environment, the F22Secretary of State may make its decision public. When publishing details of its decision F24..., the F22Secretary of State shall have regard to the legitimate interests of the recognised organisation concerned and other interested persons.

The right of the F28Secretary of State to impose fines and/or periodic penalty payments to a recognised organisation in accordance with this Regulation shall expire after five years from the date when the action or omission of the recognised organisation giving rise to an infringement identified in accordance with Article 3 of this Regulation was committed. However, in case of continuing or repeated actions or omissions giving rise to an infringement, time shall begin to run on the day on which the action or omission ceases.

The right of the F28Secretary of State to impose periodic penalty payments to a recognised organisation in accordance with Article 15 of this Regulation shall expire after three years from the date when the action or omission of the recognised organisation, for which the F28Secretary of State requested appropriate preventive and remedial action, was committed.

Any action taken by the F28Secretary of StateF29... for the purpose of the assessment or the infringement procedure in relation to an action or omission of the recognised organisation shall interrupt the relevant limitation period established under paragraph 1. The limitation period shall be interrupted with effect from the date on which the action of the F28Secretary of StateF30... is notified to the recognised organisation.

Each interruption shall start time running afresh. The limitation period shall, however, not exceed a period equal to twice the initial limitation period, except where limitation is suspended pursuant to paragraph 4.

The limitation period for the imposition of periodic penalty payments shall be suspended for as long as the decision of the F28Secretary of State is the subject of F31judicial proceedings F32....

The right to F33commence judicial proceedings or arbitration for fines and/or periodic penalty payments shall expire one year after the Decision pursuant to Article 19 has become final.

The limitation period referred to in paragraph 1 shall be interrupted by any action of the F34Secretary of State, aimed at enforcing payment of the fines and/or periodic penalty payments.

Each interruption shall start time running afresh.

The time limits laid down in this Regulation shall run from the day following receipt of the F36Secretary of State's communication or delivery thereof by hand.

In the case of a communication addressed to the F37Secretary of State, the relevant time limits shall be deemed to have been met when that communication has been dispatched by registered post before the relevant time limit expires.

In setting the time limits, the F37Secretary of State shall have regard both to due process rights and the specific circumstances of each decision-making procedure under this Regulation.

Where appropriate and upon reasoned request made before the expiry of the original time limit, time limits may be extended.