Approval of operating enterprises

An operator wishing to handle foodstuff and put it on the market must be approved for the purposes of the Food Act before commencing activities.

Approval means, in substance, a permit granted by a competent authority for starting the handling of foodstuffs. However, not all the food businesses must be approved under the appropriate procedure.

The following operators must obtain an approval:

1) food business operators subject to approval as provided by Article 6 3), b) and c) of the Regulation of the European Parliament and of the Council (EC) No. 852/2004 of April 2004, including food business operators handling food of animal origin;

2) food business operators involved in handling of immediate products of animal origin, not involving the changing of their original form and original properties, with the exception of operators involved in manufacture of such immediate products and any operations, conducted by the operator with such products, match the purposes provided in the Regulation of the European Parliament and of the Council (EC) No. 852/2004, for example, packaging of eggs and honey;

3) food business operators involved in handling of immediate products of non-animal origin, involving the changing of their original form and original properties, for example, processing of fruits and vegetables;

4) food business operators involved in processing of foodstuff, including the manufacturing or packaging, with the exception of packaging of immediate products of non-animal origin;

5) food business operators handling food of animal origin, marketing thereof to another operator, specified in Chapter III of Annex II of Regulation of the European Parliament and of the Council (EC) No. 852/2004;

5) food business operators storing food that must be kept at a temperature lower than room temperature for the purposes of assuring food safety. This category includes wholesale companies handling food that be kept at a temperature lower than room temperature for the purposes of assuring food safety;

6) business operators involved in retail trade and handling food that must be kept at a temperature lower than room temperature for the purposes of assuring food safety.

As provided by the Food Act, all the operators shall be approved by the Agriculture and Food Board.

Approval represents a procedure, involving the assessment and approval of an operator or its part, used for handling food, against the requirements of the Food Act, Regulations of the European Parliament and of the Council (EC) No. 852/2004 and 853/2004 and other relevant legislation regulating issues related to foodstuffs.

As mentioned above, food business operators handling food must communicate a written application for the approval of a business before handling is commenced. The company may be approved either in its entirety or in parts. The operator is required to communicate the required information and documents with the request for approval. The competent authority shall check the supplied information and documents, then assessing the business’s compliance with the provided information and requirements established for the business. If the business is found to comply with the requirements, the head of the competent authority shall adopt a decision regarding the approval of the business. The operator is granted approval to conduct business in a specific handling area and area of activity and for handling certain categories of foodstuffs.

As a rule, the approval decision is adopted without a term. Nevertheless, as the compliance of an operator can only be assessed in the process of handling, taking place in the business or if constructional, technological, work organisation related or other reorganisations, not having direct influence on assuring food safety in a business, were identified during the approval process, the Food Act provides the competent authority with an opportunity to issue a decision of conditional approval with the initial term of three months. Should an inspection, conducted at the expiry of the term of conditional approval, reveal that the operator does still not meet all the relevant conditions, but obvious progress can be identified, the decision of conditional approval may be extended, but such approval must not be extended, in total, over the period of six months. The competent authority must either adopt a decision of approval with regard of the operator at the expiry of the conditional decision or refuse from approving the operator.

Should an operator fail to meet the requirements, established for the operator, the head of a competent authority shall adopt a decision to refuse the issue of approval to the food business operator.

Should an operator ignore the requirements, provided by the Food Act, the competent authority may either suspend the approval decision for a certain period or revoke the decision either in part or in full. If this is the case, the respective food business operator is required to suspend or terminate the handling of food, respectively.

Last updated: 15.12.2020