Government Decree No. 98 / 2005 Coll.
Government Regulation establishing a Rapid Alert System on the risk to the health of people from food and feed
Valid
Regulation
Effective from 01.03.2005
Text versions:
01.03.2005
28.02.2005
98
GOVERNMENT REGULATION
of 9 February 2005
establishing a rapid warning system on the risk to human health from food and feed
The Government orders pursuant to § 18 (2) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws, as amended by Act No. 316 / 2004 Coll., and under § 16b (3) of Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 21 / 2004 Coll.:
Subject matter
(1) This Regulation (1) regulates, following the directly applicable regulation of the European Communities (2), the Rapid Alert System (3) to endanger the health of people from food (4) and feed (5) (hereinafter referred to as the Rapid Warning System) and the tasks, manner and procedures for the transmission of information to the competent central authorities involved in the Rapid Warning System.
(2) The members of the network (6) in the Rapid Alert System are the State Agricultural and Food Inspection7) (hereinafter referred to as the National Contact Point), the Central Audit and Examination Institute8), the public health authorities 9), the veterinary authorities 10), the customs authorities 11), the State Nuclear Safety Authority, the Ministry of Justice and the Ministry of Agriculture.
Basic concepts
(1) Original notification means a report classified as warning or information and sent on a form issued by the Commission of the European Communities (hereinafter referred to as "the European Commission"), which contains:
(a) a description of the danger;
(b) a detailed description of the food (4) or feed (5) presenting a direct or indirect risk to human health (the "risk product");
(c) a description of the investigations carried out;
(d) identification of the lot (12);
(e) the origin and description of the placing on the market of a risk product which is placed on the market of more than one State involved in the rapid alert system at the time of its initial finding.
(2) Additional notification means a report supplementing the original notification for new information.
Tasks of members of the network
(1) For the transmission of original or additional notifications in the Rapid Alert System, network members shall use only designated contact persons or their representatives. Network members communicate using e-mail, fax or telephone.
(2) Individual members of the network
(a) process and regularly update methodological procedures for the transmission of information containing a detailed description of the activities carried out and a detailed description of the exchange of information (hereinafter referred to as "methodological procedures for the transmission of information");
(b) designate a contact person and its representative for communication with the National Contact Point to whom they shall notify their contact electronic addresses, fax numbers, telephone numbers and any changes to such data;
(c) communicate with each other when dealing with situations arising from the receipt and dispatch of an original or additional notification, taking into account the nature of the risk within the shortest possible period;
(d) draw up an original or additional notification and ensure its translation into the English language;
(e) ensure that personnel with access to information in the Rapid Alert System comply with confidentiality rules 14).
(3) The contact person in connection with the notification of a risk product shall always inform the Ministry of Agriculture and, in the case of food, the Ministry of Health of communication with representatives of a country not participating in the rapid alert system.
(4) The original or additional notification received and dispatched pursuant to paragraph 1 shall be treated in accordance with specific legislation15 after its use.
Tasks of the National Contact Point
National Contact Point
(a) ensure the exchange of original or additional notifications between the Czech Republic and the European Commission in the Rapid Alert System;
(b) checks the accuracy and completeness of the forms issued by the European Commission;
(c) communicate with other members of the network when dealing with situations arising from the receipt and dispatch of original or additional notifications, taking into account the nature of the risk within the shortest possible time;
(d) provide continuous emergency services;
(e) convene meetings of members of the network as necessary, but at least once a year;
(f) process and update an overview of the original or additional notifications in the Rapid Alert System and carry out statistical evaluations for the needs of network members;
(g) compiles an overview of the original or additional notifications for publication on the website of the Food Safety Information Centre of the Institute of Agricultural and Food Information,
(h) in its activities it follows guidelines issued by the European Commission and the Ministry of Agriculture.
Procedure of the National Contact Point when notifying the occurrence of a risk product by a network member
If the presence of a risk product is notified by a member of the network, the National Contact Point
(a) verify the completeness of the draft original notification or, where appropriate, request the addition of missing information;
(b) circulates the draft original notification to all members of the network;
(c) send without delay a certified and complete original notification to the European Commission, including the members of the network, after a period of 24 hours after the proposal referred to in point (b) has been circulated; at the request of the Authority [§ 7 (4) (b)], send the original notification to the European Commission immediately,
(d) after confirming the classification of the original notification, the European Commission shall circulate this information to all members of the network;
(e) inform the European Commission of the measures taken on the basis of the original notification or additional notification received from network members;
(f) inform the European Commission in the form of an additional notification of how the measures taken have been implemented, in particular whether they have been amended, withdrawn or revoked.
Procedure of the National Contact Point when notifying the European Commission of the occurrence of a risk product
(1) If the European Commission notifies the presence of a risk product on the market in the Czech Republic, the National Contact Point
(a) send the original or additional notification to all other members of the network, with the notification to the Office of Nuclear Safety only in the event of contamination of radionuclide;
(b) draw up, from the additional notifications received from network members, a complete additional notification of the measures taken, supported by any marketing of the notified risk product to countries participating in the rapid alert system, including the list of customers and the identification of lots (12), and the quantities of risk products marketed;
(c) send a draft additional notification to the European Commission and to all members of the network.
(2) Where the presence of a risk product produced in the Czech Republic is notified, the list of customers, the determination of the lot (12) and the quantity of the risk product placed on the market shall also be followed in accordance with paragraph 1, with additional notification to the European Commission.
Procedure for the presence of a risk product by State Supervisors and Customs Authorities
(1) The State Supervision Authority or the Customs Authority, within the scope of its competence in the Rapid Alert System established by specific legislation16) (hereinafter referred to as the "competent State Supervision Authority"), shall assess the risks and, in the case of a risk product likely to occur on the market in another State involved in the Rapid Alert System or, for security reasons, shall decide on its notification at the external borders of the European Union in the Czech Republic.
(2) In the case of a identified risk product, the competent authority of the State shall classify the original notification in accordance with the methodology for the transmission of information.
(3) The competent national supervisory authority may request a professional risk assessment. It shall inform the Ministry of Agriculture of this request.
(4) The relevant competent authority of the State surveillance following the notification decision referred to in paragraph 1 and the implementation of its classification referred to in paragraph 2
(a) draw up a draft original notification;
(b) send the draft original notification to the National Contact Point; in the case of an original notification classified as a warning, the National Contact Point may request the immediate dispatch of this notification to the European Commission; in other cases, the proposal shall be circulated through the National Contact Point for comments to the other members of the network with a request for comments and comments, as a general rule within 24 hours;
(c) in the case of new facts, inform the National Contact Point by means of an additional notification.
Procedure for notifying the occurrence of a risk product by the national contact point of the relevant competent authority
Where the occurrence of a risk product is notified by the National Contact Point, the competent authority of the State surveillance authority concerned shall:
(a) confirm receipt of the original or additional notification to the National Contact Point;
(b) certify to the National Contact Point the substantive jurisdiction to carry out the inspection (16), which it will subsequently carry out; If, in carrying out an inspection, it finds that a risk product has been distributed to places falling within the competence of another relevant competent authority, it shall immediately inform that authority and the National Contact Point,
(c) on the basis of the checks carried out under (b), send an additional notification to the National Contact Point of the measures taken concerning the notified risk product.
Efficacy
This Regulation shall enter into force on 1 March 2005.
Prime Minister:
JUDr. Gross v. r.
Minister for Agriculture:
Ing. Palas v. r.
1) It shall be issued for the implementation and within the limits of the laws, the content of which allows to be adapted following the regulation of the Government of the European Communities directly applicable.
2) 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, as amended.
3) Article 3 (9) of Regulation (EC) No 178 / 2002, as amended.
4) Article 2 of Regulation (EC) No 178 / 2002, as amended.
5) Article 3 (4) of Regulation (EC) No 178 / 2002, as amended.
6) Article 50 (1) of Regulation (EC) No 178 / 2002, as amended.
7) Article 15 (4) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 316 / 2004 Coll.
8) Article 16b (1) of Act No. 91 / 1996 Coll., on Feed, as amended by Act No. 21 / 2004 Coll.
9) Article 78 of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 320 / 2002 Coll.
10) Article 47 of Act No. 166 / 1999 Coll., on Veterinary Care and on the Amendment of Certain Related Acts (Veterinary Act), as amended by Act No. 131 / 2003 Coll.
11) Paragraph 3 (6) of Act No. 110 / 1997 Coll., as amended by Act No. 316 / 2004 Coll.
12) § 2 (u) of Act No. 110 / 1997 Coll., as amended by Act No. 316 / 2004 Coll.
13) Article 3 (8) of Regulation (EC) No 178 / 2002, as amended.
14) Article 52 of Regulation (EC) No 178 / 2002, as amended.
15) Act No. 499 / 2004 Coll., on archiving and file service and on amending certain laws.
16) Act No. 110 / 1997 Coll., as amended. Act No. 91 / 1996 Coll., as amended. Act No. 146 / 2002 Coll., on State Agricultural and Food Inspection and on the amendment of certain related laws, as amended. Act No. 166 / 1999 Coll., as amended. Act No. 258 / 2000 Coll., as amended. Act No. 102 / 2001 Coll., on general product safety and amending certain laws (Act on general product safety), as amended. Act No. 147 / 2002 Coll., on the Central Audit and Examination Institute of Agriculture and on the amendment of certain related laws (Act on the Central Audit and Examination Institute of Agriculture), as amended. Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionizing Radiation (Atomic Act) and on the amendment and addition of certain laws, as amended.
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Regulation Information
| Citation | Government Regulation No. 98 / 2005 Coll., establishing a rapid warning system on the risk of human health from food and feed |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 28.02.2005 |
|---|---|
| Effective from | 01.03.2005 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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