Decree of the Ministry of Agriculture No. 147 / 1998 Coll.
Decree of the Ministry of Agriculture on how to determine critical points in production technology
Valid
Order
Effective from 01.10.1998
147
DECLARATION
Ministry of Agriculture
of 18 June 1998
on the method of determining critical points in production technology
According to Section 18 (e) of Act No. 110 / 1997 Coll., on Food and Tobacco Products and on the amendment and addition of certain related laws, hereinafter referred to as "the Act":
For the purposes of this decree:
(a) a critical point in the technological section, which is the process or operation of the production process or the process of putting food into circulation (1), in which there is the greatest risk of a food's health breach and in which control of various types of hazards to the health of the food is applied in order to prevent, exclude or reduce those hazards,
(b) the critical limit of the characters and their values which form the boundary between the permissible and the unacceptable condition at the critical point;
(c) a plan for a critical point system, a document prepared in accordance with the principles of the critical point system and laying down the way in which the hazards of a food breach are controlled in a specified part of the food chain;
(d) a system of critical points to identify, evaluate and control significant hazards at critical points;
(e) the danger of a biological, chemical or physical agent in a food which may infringe its health;
(f) risk analysis of the process of collecting and evaluating information on the different types of hazards to the health of the food and the conditions for their presence in the food required for decisions on their relevance to the safety of the food and their inclusion in the critical points system plan;
(g) control measures any action that may be used to prevent or eliminate a danger to the health of a food or to reduce it to a permissible level;
(h) by monitoring the observations and measuring the defined characteristics determined by the procedure for assessing whether the critical point is in the state of control;
(i) a state of control in which the procedures laid down are observed at critical points and the values of the characteristics observed are in the permissible state;
(j) verification procedures for assessing whether the critical points system plan effectively controls significant hazards and whether the plan is being followed;
(k) good hygiene practice in compliance with all the legally modified hygiene requirements and obligations in the process of producing and putting into circulation food and the application of hygiene rules consistent with generally recognised scientific knowledge for the achievement and preservation of healthy foods. The Ministry of Agriculture publishes the rules of good hygiene practice in the Bulletin of the Ministry of Agriculture of the Czech Republic and in the Czech Technical Standard, 2)
(l) an internal audit of the systematic and independent assessment of the level of the critical point system and its compliance with the critical point system plan by personnel not directly responsible for the critical point system created.
Method of determination of critical points
(1) The critical points system is adjusted
(a) in the case of food production for each production process separately by type of food, taking into account the manner and extent of food production in the food business concerned, 3)
(b) in the case of the putting into circulation of foodstuffs for each process of putting into circulation separately by group of foodstuffs of the same nature, taking into account the manner and conditions in which they are put into circulation by the food business concerned.
Within the critical points system, the food business operator may apply rules of good hygiene practice.
(2) If there is a danger to be controlled and if no critical point has been found in the production or putting into circulation process, this procedure shall be revised so that the critical point can be determined. When a critical point has not been found even after modification of the production process or putting into circulation, the production process or putting into circulation cannot be used.
(3) When applying a critical point system in the production process or when putting into circulation, any modification (modification) of the product, process and extent of production or putting into circulation, or any step, the critical point system shall be reviewed and the necessary changes shall be made to determine critical points.
(4) The critical points shall be determined in accordance with the principles and the stages of their implementation set out in the Annex.
(5) After the definition of the manufacturing activity and the responsibility of the food business operator, a description of the product, a diagram of the production process and its confirmation in service shall be made. The product description shall include:
(a) relating to health, in particular the composition, biological, chemical and physical characteristics;
(b) microbial or microbiostatic treatment (heat treatment, freezing, loading, smoking, salting, use of preservatives),
(c) the method of packaging,
(d) the date of application or the date of minimum durability and characteristics of the food, including evidence of the accuracy of the determination of the date of application or of the date of minimum durability and storage conditions;
(e) the manner and conditions in which the product is put into circulation;
(f) the technological process for the production of the product;
(g) the intended use of the product.
(6) In addition, a hazard analysis shall be carried out involving:
(a) the collection and evaluation of information on the different types of hazards and the conditions for their presence, as well as the decision to include the hazards relevant to the food health breach in the critical points system plan, including the setting of control measures to prevent or mitigate them;
(b) the identification of those hazards in the critical point system plan, the exclusion or reduction of which is necessary for the production of a non-safe food or the preservation of the safety of foodstuffs when they are put into circulation; the hazard identification shall be carried out according to:
1. the possible occurrence and severity of hazards;
2. qualitative or quantitative assessment of the occurrence of hazards,
3. the possibility of surviving and multiplying micro-organisms,
4. the occurrence and persistence of toxins, undesirable chemicals and physical properties in food and, under conditions leading to this hazard,
(c) the determination of control measures for each of the identified significant hazards.
(7) Where the food business operator applies the rules of good hygiene practice referred to in paragraph 1 and the hazard analysis demonstrates its ability to control that risk, the system and the extent of the critical points may adapt those rules.
(8) For each critical point, one or more characters and values of their critical limits shall be specified. Critical limits shall be given in particular in temperature, time, humidity, pH, water activity and the results of sensory tests.
(9) The monitoring system shall be defined for each critical point so that:
(a) the monitoring has been able to detect any threat to the controlled condition at a critical point and has enabled, according to the data found, the necessary adjustment to manage the production or putting into circulation process in a timely manner and to avoid exceeding critical limits;
(b) the results of the monitoring have made it possible to adjust the relevant process where only an adverse trend or excessive data dispersion occurs before reaching the critical limit;
(c) the monitoring data have been evaluated by a worker authorised by the food business operator and eligible for corrective actions;
(d) the monitoring records have been signed at specified intervals by the monitoring officer and the records related to the system review have been signed by the reviewer, each time after the activity has been carried out;
(e) the signature of the food business operator or the person responsible for monitoring at critical points has been on the records referred to in point (d).
(10) Corrections shall be drawn up for each critical point to ensure that the critical point is placed in a controlled state as soon as the critical limit is exceeded. Corrective measures shall include measures for the management of food or a group of foodstuffs of the same nature, produced or put into circulation in an unresolved state, including whether it complies with the health requirements. The excess over the critical limits and the procedures for handling the product shall be documented in the maintained records of the critical point system.
(11) The timing of the verification procedures and internal audits shall also be established to determine the accuracy of the plan and the effectiveness of the critical points system. Verification procedures shall include in particular:
(a) verification of the correctness of the critical points plan (review of the different elements of the plan, hazard analysis, identification of the characteristics pursued, methods and frequency of monitoring, values of critical limits and corrective actions, timing of verification procedures and internal audits);
(b) verification of the monitoring methods at critical points when operating the critical points system (use of other methods, verification of sensors, check of correctness);
(c) verification of the functioning of the critical points system (review of the critical points system and its records, review of the excess of critical points and the way in which the product is handled, confirmation that the critical points are in a manageable state, evaluation of other related information, results of the output control, product analyses, complaints).
(12) A system of records shall be established containing documentation, all supporting documents from the implementation of the critical points system and subsequent records of its operation. The registration shall include:
(a) documentation, in particular:
1. definition of the manufacturing activity and responsibilities of the food business operator;
2. product specification,
3. process diagrams;
4. hazard analysis including control measures at critical points;
5. determination of critical points,
6. determination of critical limits,
7. monitoring procedures,
8. Determination of corrective measures;
9. Timetable for verification procedures and internal audits,
(b) records, in particular:
1. modification of the critical point system;
2. monitoring at critical points;
3. exceeding critical limits and related corrective measures;
4. the results of the verification procedures used and internal audits;
5. Treatment of the product produced in an unattended state.
(13) The food business operator who produces foodstuffs shall keep the documentation for at least 1 year after the end of the production of the food and records for at least 1 year after the end of the date of minimum durability or applicability. In the case of foodstuffs which are not required to be labelled with a minimum durability date under special legislation4), the records shall be kept for at least 1 year from the date of manufacture, with the exception of drinking alcohol, spirit drinks and other alcoholic beverages of an alcoholic strength of 10% vol or more and natural sweeteners (5) in a solid state where the records are kept for at least 5 years from the date of manufacture.
(14) The food business operator who puts food into circulation shall keep documentation and records 1 year after the food or food group of the same nature has been put into circulation.
The provisions of Sections 2 (5), 2 (12) (a) (1) to (3) and points 1 to 4 of the Annex shall not apply to food business operators putting food into circulation.
Transitional provision
The manufacturer shall determine the critical points in the production technology and, after verifying their accuracy, adjust the overall critical points system in order to comply with the requirements set out in Section 2 until 31 December 1999 at the latest.
Efficacy
This Decree shall take effect on 1 October 1998.
Minister:
Ing. Lux v. r.
Annex to Decree No 147 / 1998 Coll.
Principles of the procedure for establishing the critical points system and their gradual implementation
1) Article 2 of Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 306 / 2000 Coll.
1a) § 24 of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related laws.
2) Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 205 / 2002 Coll., Act No. 226 / 2003 Coll. and Act No. 277 / 2003 Coll.
3) Article 3 (3) of 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.
4) Decree No. 324 / 1997 Coll., on the method of labelling of foodstuffs and tobacco products, on the tolerance from the quantity of product indicated by the symbol "e," as amended by Decree No. 24 / 2001 Coll. and Decree No. 259 / 2003 Coll.
5) Decree No. 76 / 2003 Coll., laying down requirements for natural sweeteners, honey, confectionery, cocoa powder and mixtures of cocoa with sugar, chocolate and chocolate sweets.
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Regulation Information
| Citation | Decree of the Ministry of Agriculture No. 147 / 1998 Coll., on how to determine critical points in production technology |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.06.1998 |
|---|---|
| Effective from | 01.10.1998 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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