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Interpretation of requirements of Regulation No. 852/2004 on hygiene of foodstuffs in relation to ČSN EN standards

11/03/2014
 
Question
A number of the requirements of the Regulation No. 852/2004 on hygiene of foodstuffs (hereinafter as “Regulation”) are designed in a general way taking into consideration the main goal of the Regulation – ensuring safe foodstuffs.
Nevertheless, currently there are ČSN EN standards that describe what e.g. food processing machinery (ČSN EN 13886) should look like or what solutions of other hygienic requirements should look like.
  • Is it possible to find any legal relation between the Regulation and these standards?
  • Is it possible to consider the solution in these standards as the only possible one?
  • If an inspected entity proves during an inspection that it acts in accordance with these standards, is it possible to consider it as a fulfillment of the requirements of the Regulation?

Answer
Ad 1. Generally, it can be stated that the ČSN EN standards are not considered as legal regulations and if there is not a normative reference to them in a legal regulation, in the given case in the Regulation No. 852/2004, there is no obligation stipulated to comply with them.
Ad 2. Also, it is not possible to consider the procedures given in the ČSN EN standards as the only possible solution from the point of view of ensuring safe foodstuffs. Article 5 of the Regulation No. 852/2004 implies that food business operators shall establish and implement one or more permanent procedures based on the HACCP principles and they shall follow them. At the same time Article 5 further specifies these principles. Therefore, the given statement implies that the ČSN EN standards can be understood only as one of the possible sources which a food business operator can use facultatively (alternatively) when setting up the HACCP system to fully meet the requirements of the Regulation. The facultative option of using the ČSN EN standards applies provided that these standards are not “made binding” by a normative reference in a legal regulation.
Ad 3. It is always necessary to assess individual inspection findings on a case-by-case basis, fully in the intentions of fulfillment of the requirements of the Regulation. In view of the fact that there is no legal relation between the ČSN EN standards and Regulation No. 852/2004, the procedure of the inspected entity in accordance with the ČSN EN standards does not automatically mean that all the requirements of the Regulation were fully met. Nevertheless, if the ČSN EN standards were auxiliary used by a food business operator when establishing the HACCP system and the Czech Agriculture and Food Inspection Authority evaluated the configured HACCP system as non-compliant, it is always necessary to justify in what way this configuration is viewed as incorrect.