Business Operators : 3rd Countries approved for Export to EU

Primary Producers and Associated Operations

To be established.

Other Business Operators

List of Frequently Asked Questions

1.How many hand washing basins do we need to have?

The regulation and related guidelines require that an adequate number should be available and do not provide a specific number. (Regulation (EC) 852/2004 Annex 2, ch. I). Each operator shall define what is adequate in the specific business based on the nature of the operation. Factors such as Lay out, number of sections, type of activity in each section, working routines, number of workers in need of the facilities at time etc., shall be analyzed and used to justify that the choice made is adequate to ensure that the facilities will provide for hygiene routines which will minimize the risk for contamination.

2.What are the requirements to temperature in processing and storage rooms?

The regulation and related guidelines require that suitable temperature controlled handling and storage rooms shall be available to ensure appropriate temperature of the food stuff. (Regulation (EC) 852/2004 Annex 2, ch. I). Specific temperature requirements are provided only for foodstuff of animal origin, in specific Annexes of Regulation (EC) 853/2004. The temperature in the handling and storage rooms should therefore be considered and decided on in connection with the applied flow and handling practices. If product temperature can be kept at the required level through other means, such as quick handling or, in case of fishery products, the use of ice, the internal standard for specific room temperature may be rather wide. In other words, it is required that the products are kept at the temperature requested in the legislation, whatever means are applied to do so. The internal standards and practices applied shall be justified trough validation and regular monitoring of time and temperature, which will be a part of the pre-requisite program.

3.Do we need to have automatic monitoring of the temperature in our cold stores?

The regulation requires cold stores to have capacity sufficient to maintain product temperature at least –18 C. It should be equipped with easy to read temperature recording device with the sensors for temperature recording placed in the area with highest temperature. (Regulation (EC) 853/2004, Annex III, section VIII, chapter IIIB and chapter IC and section V, chapter III). The monitoring of the temperatures is specifically regulated by Regulation (EC) 37/2005; monitoring shall take place 24 hours/day/7 days/week, and the recording shall be dated and stored for at least one year, but automatic monitoring is not specifically required. By Regulation (EC) 37/2005 it is also required that all instruments installed later that 31December 2005 and used for monitoring of storage facilities comply with international standards EN 13486 on periodic verification of recorders and EN 13485 on performance and suitability of equipment for testing of temperature in products and air of storage and transport facilities. Devices installed before this date may be used until end of 2009.

4.What are the requirements to control of raw materials?

It is required that food business operators control raw materials at receiving and reject raw materials that are known or reasonably expected to be contaminated with food safety hazards which cannot be eliminated through normal sorting, preparation or processing (Regulation (EC) 852/2004, Annex II, chap. IX). The operator shall design the controls to be conducted and be able to justify that they are efficient to control food safety. The controls may typically include a combination of monitoring and internal verification activities including physical inspection, document checks, sensory evaluation and analytical testing. An important element in the controls shall be a traceability system which allows to control and document that raw materials origin only from primary producers (farmers, fishing vessels, aquaculture farms and distributors) which are registered by competent authority to comply with criteria to supply for further export to EU. Although the competent authority may verify the primary producers' compliance with EU requirements, it is still the sole responsibility of the exporter to ensure that the raw materials are not contaminated with any hazard, e.g. residues of veterinary medicines.

5.Do we need to sample and test process water if the competent authority does it already?

Yes. The official sampling by the competent authority is only to verify that the operator ensure the safety of water. To ensure continuous supply of safe water, the operator is responsible to implement adequate monitoring as a part of the prerequisite program. Such monitoring may include regular sampling and testing of the water itself, but monitoring of treatment systems, tanks, pipes etc. is at least equal important. It is the responsibility of the operator to design the system and the related monitoring so the water is safe everywhere and any time in the operation.

6.Does EU require us to have a medical health certificate for each worker?

The requirement is that no person suffering from or being a carrier of a disease likely to be transmitted through food shall be allowed to handle food or enter food handling premises (Regulation (EC) 852/2004 Annex II, chapter VIII). The underlying understanding is, that this target shall be achieved by different means through knowledge building, reporting requirements, social security systems etc. depending of national practices and company policy. While the personal health certificate may be a method to verify that other means and daily practices are efficient it shall not alone be considered an efficient tool.

7.Are there any mandatory training programs or subjects for workers and supervisors?

General requirements are stipulated in Regulation (EC) 852/2004 Annex II, ch. XII. The regulation does not provide any mandatory training program or subjects for training of business operators' staff. However if a national program or other requirements exist, the operators are required to comply with this. The underlying understanding for the requirement is that the operator has the responsibility to ensure that all staff members are trained and/or instructed in food hygiene issues as required for adequate performance of their duties. Adequate training may include everything from formal education, short theoretical training, hands on training and instruction. It is up to the operator to demonstrate that the staff is adequate trained and instructed for safe handling of food.

8.Why do different EU countries apply different microbial criteria?

The microbiological criteria stipulated in Regulation (EC) 2073/2005 and the chemical criteria stipulated in Regulation (EC) 1881/2006, Regulation (EC) 1883/20067and Regulation (EC) 333/2007 is examples of harmonized criteria which apply mandatory in all countries. Member States are allowed to apply additional criteria to the extent that these are scientific justified and not less strict than the harmonized criteria. Any criteria not stipulated by EU regulation, decision or directive would be either a national criteria or a customer requirement, hence subject to negotiation, while harmonized criteria shall be considered not negotiable.

9.Our HACCP system is certified to one or several international standards eg. ISO 22000 and BRC, in that case do we automatically comply with the EU requirements?

Not necessarily. It shall be ensured that all specific product and process standards required by EU regulation (eg. health criteria stipulated in Regulation (EC) 2073/2005, 2074/2005 and 1881/2006 and process criteria stipulated in 853/2004 Annex II and III) are complied with. This may not be the case if the operator has not previously been active on the EU market, hence the system should be validated and eventually adjusted against these requirements. The EU authorities will consider only the HACCP plan that is approved by the competent authority of the country. ISO 22000 or any other voluntary certification may be requested by a client, but not by the competent authority of the importing country.

10.Do we need to have a laboratory in our factory?

No, the business operator is not required to have own laboratory, but access to laboratory services is needed for most companies to provide the guarantees that products comply with microbiological and chemical criteria. This service may be an external supplier. The business operator is responsible for the selection of, communication with and interpretation of results from such external supplier.

11.Does our factory laboratory need to be accredited?

No the EU regulation do not require that the business operators have an accredited in-house laboratory.

12.Does our factory laboratory need to apply the analytical test methods required by EU regulations?

Not necessarily. The factory laboratory is free to apply any test method most suitable for the purpose, which may be screening tests, rapid tests etc. for the purpose of monitoring and verifying that the HACCP system is working efficiently. Product testing used for verification as a part of the HACCP system is recommended to be conducted with the methods required by EU or at least with test methods which are proved to be equivalent to the methods required by EU (Regulation (EC) 852/2004 article 4). The EU border inspection posts and importers in EU, will always apply the test methods specified in different EU regulations.

13.Is it allowed to add chlorine to process water?

Chlorine is a strong disinfection agent and may be used in various adequate concentrations for disinfection of equipment and facilities in the establishment. Solutions of chlorine may never be used for rinsing or other direct treatment of products. It is allowed to use small concentrations of chlorine in potable water/clean water in general, if this is already allowed for all potable water by national regulation. This concentration should not exceed the limit stipulated in the national regulation or, if such regulation does not exist, the guidelines stipulated by WHO.