All Oiva evaluation guidelines for approved food establishments.
10.1 Separation and Cross-contamination
Guide/version: 2164/04.02.00.01/2021/7, valid from 1.7.2021
To be taken into consideration:
The separation and cross-contamination of the following substances causing allergies or intolerances are controlled in this point:
- cereals containing gluten, namely wheat, rye, barley, oats, and products thereof
- crustaceans and products thereof
- eggs and products thereof
- fish and products thereof
- peanuts and products thereof
- soybeans and products thereof
- milk and products thereof
- nuts and products thereof
- celery and products thereof
- mustard and products thereof
- sesame seeds and products thereof
- sulphur dioxide and sulphites
- lupin and products thereof
- molluscs and products thereof.
This point is controlled, when
1. The store or catering establishment
- prepares and/or sells unpackaged foodstuffs from a service counter
- prepares and/or sells meals
and the meals or unpackaged foodstuffs are indicated in writing or verbally to be suitable for a gluten-free or allergy diet in terms of the aforementioned allergens.
Any shortcomings found concerning the presentation of unpackaged foods or meals available in self-service sale or self-service lines are recorded in the control report, but not in the Oiva report (not evaluated).
2. Some other food establishment
- manufactures, has manufactured for it, stores and/or packages foodstuffs.
The product-specific controls of recipes and labelling on substances causing allergies or intolerances are carried out in point 13.1 Mandatory food information.
Matters to be controlled:
The implementation of own-check activities is evaluated by controlling the following matters:
- Practical arrangements and practical activities in use to verify gluten and allergen safety: the operator has identified the risks related to their own operations and has them under control; the foods do not contain any substances causing allergies or intolerances that are not included in the recipe, and no cross-contamination occurs. The objective of control is to obtain a total picture of the management of separation and cross-contamination.
- Attention is primarily focused on the work phase or activity of the highest risk-based importance, and on the substances causing allergies or intolerances that in the food establishment or premises concerned are in the key role in terms of the management of cross-contamination.
- Key work phases to be controlled include, for example:
- procurement and reception of raw materials
- marking, storage and handling or raw materials and intermediate products, as well as their routes and passage (e.g. storage containers and locations, marking of raw materials and intermediate products in a way that eliminates the risk of confusion)
- manufacture and preparation of foodstuffs and meals, production processes, transport (e.g. work utensils, work facilities, equipment, work sequence, cleanliness)
- packaging
- presentation and sale (e.g. unpackaged foods are presented in a way that eliminates the risk of cross-contamination).
- Compliance with requirements can be verified:
- through observing practical activities, interviewing the personnel
- where necessary, through a review of the own-check
- where necessary, on the basis of analysis certificates and/or own-check testing.
- The adequacy and suitability of own-check activities and, where appropriate, the plan are controlled by applying the Annex to Guideline 1.6: "Adequacy and Suitability of Own-check Activities".
Operations comply with requirements.
The separation of substances causing allergies or intolerances and the management of cross-contamination meet requirements.
There are small issues with the operations which do not impair food safety or mislead consumers.
The separation of substances causing allergies or intolerances has been taken into consideration in the operations and the management of cross-contamination meets requirements in most parts. There are some minor shortcomings in the separation of substances causing allergies or intolerances, such as
- minor shortcomings in instructions, practices and/or marking or storage of raw materials and/or intermediate products which make it impossible to verify the management of allergen safety in all respects, for example in abnormal conditions.
There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.
The separation of substances causing allergies or intolerances has been taken into consideration in the operations, but there are some essential shortcomings regarding separation which may result in the risk of cross-contamination, such as
- raw materials or foodstuffs containing substances causing allergies or intolerances are stored inadequately packaged, enclosed and/or marked
- inadequate separation in time or place between gluten-free and regular baking
- use of the same deep-frying fat for gluten-free and wheat-containing foods
- the adequacy of the cleaning activities of the production lines cannot be verified as concerns the allergens used and their state (e.g. powder/liquid)
- the presentation and arrangement of unpackaged foodstuffs may cause a risk of cross-contamination.
There are issues with the operations which jeopardise food safety or considerably mislead consumers, or the operator has failed to comply with orders that have been issued. These issues must be rectified with immediate effect.
There are issues in the separation of substances causing allergies or intolerances and management of cross-contamination which require immediate rectification or recall, such as
- the risk of cross-contamination by allergens or gluten has not been taken into consideration at all
- the food has probably been cross-contaminated by an allergen not included in the recipe
- the presentation and arrangement of unpackaged foodstuffs cause a significant risk of cross-contamination.
Legislation and guidelines (with any amendments) pertaining to the subject:
- Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, 178/2002/EC
- Regulation of the European Parliament and of the Council on the hygiene of foodstuffs, 852/2004/EC
- Finnish Food Act 297/2021
- Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers.
Updates in version 7:
- Reference to Oiva Evaluation Guideline 13.1 has been specified.
- Finnish Food Act number has been changed.
- Guideline no. 2164/04.02.00.01/2021 replaces the guideline no. 10232.