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Corrigendum to Commission Decision 2004/478/EC of 29 April 2004 concerning the adoption of a general plan for food/feed crisis management

(Official Journal of the European Union L 160 of 30 April 2004)

Decision 2004/478/EC should read as follows:

COMMISSION DECISION

of 29 April 2004                     

concerning the adoption of a general plan for food/feed crisis management

(2004/478/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 55 thereof,

Whereas:

HAS ADOPTED THIS DECISION:

Article 1

The general plan for food/feed crisis management, provided for in Article 55 of Regulation (EC) No 178/2002 and set out in the Annex, is hereby established.

Article 2

This Decision shall enter into force on the first day of the month following its publication in the Official Journal of the European Union.

Done at Brussels, 29 April 2004.

For the Commission

David BYRNE                        

Member of the Commission

ANNEX

GENERAL PLAN FOR FOOD/FEED CRISIS MANAGEMENT

1.   Scope of the general plan for food/feed crisis management

Section 3 of Chapter IV of Regulation (EC) No 178/2002 envisages new methods of risk management in the field of food and feed: the setting-up by the Commission of a crisis unit in which the Authority participates and the adoption of a general plan for food/feed crisis management specifying, in particular, the practical procedures necessary to manage a crisis. The general plan for food/feed crisis management is hereinafter referred to as the ‘general plan’.

The three articles of section 3 are interconnected:

Article 55 provides for the drawing up by the Commission, in close cooperation with the Authority and the Member States, of a general plan for food/feed crisis management which specifies the crisis situations and the practical procedures necessary for managing a crisis, including the principles of transparency to be applied and a communication strategy.

Article 56 provides for the constitution of a crisis unit by the Commission.

Article 57 specifies the tasks of the crisis unit.

In particular, according to Article 55, the general plan shall specify the types of situation involving direct or indirect risks to human health deriving from food and feed which are unlikely to be prevented, eliminated or reduced to an acceptable level by provisions in place or by way of the application of Articles 53 and 54.

In addition, Article 56 provides that the Commission shall set up a crisis unit ‘when it identifies a situation involving a serious direct or indirect risk to human health deriving from food or feed and the risk cannot be prevented, eliminated or reduced by existing provisions or cannot be managed adequately solely by way of application of Articles 53 and 54’.

Therefore, the general plan specifies:

The management procedures established by the general plan will constitute guidelines applicable to the Member States, the Authority and the Commission.

2.   Crisis situations

2.1.   Crisis situations involving a serious direct or indirect risk to human health

The crisis situations are those where critical factors are involved at such a level that the Commission considers that the management of the risk in question deriving from food or feed will be of such complexity that it cannot be managed adequately by existing provisions or solely by way of application of Articles 53 and 54.

Experience has shown that situations involving risks are normally managed appropriately using existing procedures. This means that the situations which should be considered to be crisis situations will be very few in number, not to say exceptional.

These critical factors are, in particular, the following:

the situation involves a serious direct or indirect risk to human health and/or is perceived or publicised as such or can be perceived and/or publicised as such

and

the risk is spread or could be spread by a large part of the food chain

and

it is highly likely that the risk will spread to several Member States and/or non-Community countries.

The general plan implies the setting up of a crisis unit where the direct or indirect risk involved is considered to be serious. The general plan will therefore include in almost all cases the setting up of a crisis unit.

2.2.   Crisis situations where there is a potentially serious risk

It is important to provide in the plan for cases where the risk is potential but could evolve into a serious risk which is unlikely to be prevented, eliminated or reduced by existing provisions or solely by way of application of Articles 53 and 54. In this case, a crisis unit will not be set up but adequate provisions should be made to ensure effective management of this type of situation.

3.   Procedure leading to the application of the general plan

Information possibly leading to the application of the general plan for food/feed crisis management and, where necessary, to the setting up of a crisis unit may originate from:

When, on analysing the information concerning risks, the Commission takes the view that the conditions established in sections 2.1 or 2.2 might be met, it shall make preliminary contact with the Member State(s) concerned to examine the situation and with the Authority to request information on the risk involved.

On the basis of the assessment of all relevant information available, the Commission shall determine whether the conditions set out in section 2.1 or section 2.2 have been met.

4.   Establishment of a network of crisis coordinators

Each Member State, the Authority and the Commission shall designate one crisis coordinator and his/her alternate at the appropriate level. The names and contact details of the designated coordinators and alternates shall be notified to the Commission.

Meetings of the coordinators shall be organised by the Commission shortly after their designation. At the first meeting, the Commission shall distribute a handbook providing a complete list of the coordinators and alternates and their contact details. The handbook shall also include a list of the Community Reference Laboratories. Practical operating procedures will be discussed in order, for instance, to ensure that each coordinator can be contacted at short notice in the event of a crisis or that effective cooperation is ensured on the risk communication strategy (see section 7). Stakeholders shall be consulted about the results of these meetings which are of interest to them.

The practical procedures should ensure that action is taken quickly. Where necessary, they will be annexed to the general plan.

5.   Practical procedures for the management of a crisis involving a serious direct or indirect risk to human health

5.1.   Establishment of the crisis unit

When, on analysing the information concerning risks, the Commission takes the view that the conditions listed in section 2.1 might be met and, in particular, that the risk is likely to be serious, it shall make preliminary contact with the Member State(s) concerned to examine the situation and with the Authority to request information on the risk involved.

On the basis of the assessment of all relevant information available, the Commission shall set up a crisis unit if the conditions mentioned in section 2.1 are considered to be met.

The Commission shall immediately inform the Member States and the Authority that a crisis unit has been set up.

The decision to set up a crisis unit will mean that sections 5, 7 and 8 of the general plan apply to all the parties concerned (Commission, Authority, Member States).

5.2.   Role of the crisis unit

The crisis unit shall be responsible for gathering and evaluating all the relevant data and identifying the options available for managing the crisis.

It shall also have the role of informing the public about the risks in question and the measures taken in this regard.

The crisis unit is an additional tool for ensuring that crises are managed effectively by ensuring better coordination and by taking action quickly. Consequently, all members of the crisis unit shall have to cooperate in order to collect and share all available relevant information; they shall also work together on the evaluation of the data collected and identify appropriate risk management options. The members of the crisis unit shall also cooperate on communication and identify the best ways of informing the public in a transparent way.

However, the crisis unit is not responsible for adopting decisions on the management of risk or for implementing legislation (control aspects).

Its operational methods will not replace the procedures used in the framework of the Commission's or the Member States' or the Authority's own competence.

As a consequence, crisis management decisions shall be adopted according to specific procedures already in place (in particular, comitology procedures).

Each Member State shall continue to be responsible for the management of official controls on its territory. The specific procedures they have put in place to coordinate the necessary urgent controls in situations of crisis will remain. The Health and Consumer Protection Directorate-General shall be responsible for sending urgent missions from the FVO, if necessary.

Similarly, the Authority shall continue to be responsible for managing the procedures for providing a scientific opinion in the event of a request for an urgent scientific opinion from the Scientific Committee or one of its scientific panels.

5.3.   Practical operation of the crisis unit

Composition

The crisis unit shall be composed of the crisis coordinators (or their alternates) from the Commission and the Authority, the crisis coordinator(s) of the Member States directly concerned and other representatives of the Commission, the Authority and the Member State(s) directly concerned. The Authority shall provide the necessary scientific and technical assistance.

The purpose of the crisis unit will be to facilitate rapid and efficient action. Its members will be involved in regular and emergency meetings of the crisis unit and will need to demonstrate a high degree of expertise and commitment. They will have to be able to take on a number of responsibilities, which means that it is necessary to designate people with a high level of responsibility in the food/feed sector.

The crisis unit may consider that the expertise of other public or private persons is necessary for the management of the crisis and may request the permanent or ad hoc assistance of these persons. For example, experts from the Community or national reference laboratories may be requested to take part in the crisis unit when their expertise as regards laboratory analyses is needed.

The persons responsible in the Commission and in the Authority for communication on food and feed safety shall be associated with the work of the crisis unit.

Practical procedures for the operation of the crisis unit

The Commission's crisis coordinator (or his/her alternate) shall chair the crisis unit. The Chair shall, in particular, ensure the link between the work of the crisis unit and the decision-making process. He/she shall be assisted by the appropriate technical expert(s) of the competent Unit(s) concerned in the Commission.

The Chair shall ensure the smooth operation of the crisis unit and the distribution of tasks amongst members, taking into account their competence.

As soon as possible after it has been decided to set up a crisis unit, the Chair shall invite the Authority's coordinator and the coordinators of the Member States directly affected by the crisis to a first meeting of the crisis unit. Coordinators may be accompanied by a limited number of persons. The Chair may specify a limit for the maximum number of accompanying persons.

The Authority's coordinator and the Member States' coordinators involved in the crisis unit must ensure adequate participation in the meetings of the crisis unit in terms of availability, expertise and level of responsibility. In concrete terms it will mean that the crisis coordinator or his/her alternate will attend all meetings and will be accompanied by the relevant persons.

The Authority shall be responsible for providing scientific and technical assistance if necessary, in particular regarding the state of scientific knowledge (collection and evaluation of all relevant scientific information in relation to the risk in question).

The crisis unit shall be responsible for maintaining close contact with the stakeholders concerned, in particular when information has to be shared.

Means of operation

The Commission shall staff the secretariat for the meetings of the crisis unit (minutes etc.) and place at the disposal of the crisis unit all the human and material resources necessary for its smooth operation (in particular, meeting rooms, means of communication, etc.).

The crisis unit will use the technical arrangements in place for the RASFF network to communicate or disseminate information, particularly requests for information to the Member State(s) and the information submitted by them.

Action taken by the crisis unit

In accordance with Article 57 referred to above, the crisis unit shall take the following action:

The allocation of tasks on the collection of scientific data shall take into account the specific expertise of the Authority and the mechanisms for sharing scientific data already set up by the Authority on these issues (Authority's networks).

The allocation of tasks on the collection of scientific data may also include, where necessary, the assistance of other networks managed by the Commission, such as the Rapid Alert and Response System (EWRS) in the field of human illnesses or the ADNS in the field of animal health or the networks operating in the area of research and managed by DG Research.

This matter is explored in more detail in section 7.

For all kinds of action taken, the crisis unit may request the permanent or ad hoc assistance of specific persons when their expertise is considered necessary.

5.4.   Link between the crisis unit and the decision-making process

Action relating to crisis management

The action relating to crisis management includes all action necessary for preventing, reducing and eliminating the risk involved: the crisis unit will be responsible for certain types of action, and the Commission and/or the Member States for others. The action taken will be without prejudice to the possibility set out in Article 53(2) for the Commission to adopt provisional measures in the event of emergencies, after consulting the Member States concerned and informing the other Member States.

Step 1

Step 2

Step 3

Permanent action to be taken throughout the crisis

Link between the crisis unit and the decision-making process

5.5.   Resolution of the crisis

The above procedures will remain in place until the crisis unit is dissolved. When the Commission considers, after consulting the crisis unit and in close collaboration with the Member States through the Standing Committee on the Food Chain and Animal Health, that the work of the crisis unit is completed because the risk has been brought under control, it may dissolve the crisis unit.

5.6.   Post-crisis assessment

An overall post-crisis assessment, involving the stakeholders, shall be undertaken. A meeting of the crisis coordinators shall be held after the conclusion of a crisis in order to improve the operational procedures for the different tools used in crisis management, in light of the post-crisis assessment and on the basis of the experience gained.

6.   Management procedures in the event of a potentially serious risk

When, on analysing the information concerning risks, the Commission takes the view that the conditions listed in section 2,2 might be met, it shall make preliminary contact with the Member State(s) concerned to examine the situation and with the Authority to request information on the risk involved.

On the basis of the assessment of all relevant information available and if the Commission considers that the conditions established in section 2,2 have been met, the Commission shall immediately inform the Member States and the Authority that sections 6, 7 and 8 of the general plan are applicable.

As soon as possible after it has been decided to apply this section of the general plan, the Commission shall take the following action:

This action will continue to be taken until the risk has been assessed more fully. If the risk is considered to be serious and if the Commission considers that the conditions set out in section 2.1 have been met, a crisis unit shall be set up and the procedures provided for in sections 5, 7 and 8 shall apply.

If the risk is not considered to be serious, the existing normal provisions for the management of risk shall apply.

7.   Communication strategy

The crisis unit shall develop its communication strategy in line with the case in hand in order to keep the public informed about the risk and the measures taken.

This communication strategy shall cover the content of the message and the timing of the communication on the problems in question, including appropriate arrangements for its release.

The strategy shall take account of the specific competence and responsibilities of each of the unit's members when it comes to communicating with the public in a coordinated, consistent and transparent way. To this end, provision is made for the following procedures:

The strategy adopted by the crisis unit shall involve making use of whichever channels of communication are appropriate for the cases which arise with the European Parliament and with the non-Community countries and parties concerned.

The communication strategy developed by the crisis unit shall include making appropriate preliminary contact with stakeholders where necessary and, in particular, when information is released in relation to a specific commercial brand or name.

The communication strategy shall take account of the specific role played by the organisations representing stakeholders at European level in relaying information.

The communication strategy will include establishing appropriate coordinated contacts with the non-Community countries concerned in order to provide them with clear, precise and coherent information. The communication strategy shall also include transmitting appropriate information to non-Community countries to warn them that the crisis has been resolved.

The communication strategy shall ensure that the communication process is transparent, in accordance with the principles set out in section 8.

When information is communicated as defined in section 6 of the general plan, the necessary coherence of the communication needs also to be ensured. The contacts and meetings provided for in this section shall cover, where necessary, a communication strategy to be developed in line with section 7.

8.   Principles of transparency

When the crisis unit issues a communication, it shall take great care to ensure transparency in accordance with the principles for public information provided for in Article 10 of Regulation (EC) No 178/2002.

The general confidentiality rules will continue to apply. Furthermore, the specific confidentiality rules provided for in Article 52 of Regulation (EC) No 178/2002 will apply to the exchange of information carried out under the RASFF.

When the crisis unit communicates the results of work carried out by the Authority on its behalf, the principles of transparency and confidentiality provided for in Articles 38 and 39 of Regulation (EC) No 178/2002 with regard to the results of the Authority's work will apply.

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(1)OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Council Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

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