All Oiva evaluation guidelines for registered food premises.
14.1 Packaging Materials and Other Food Contact Materials
Guide/version: 2178/04.02.00.01/2021/9, valid from 1.9.2022
To be taken into consideration:
This point is to be controlled in retail stores and catering facilities as well as other registered food premises and approved food establishments in cases where the operator handles, manufactures, has manufactured for it, stores, packages, imports (from the internal market or third countries), transports or suppliers (e.g. agency business) foodstuffs.
- The control concerns packaging materials and other materials, machines, equipment, utensils and articles (e.g. transport containers, receptacles, utensils, disposable gloves) that come into contact with food.
- When the control concerns machinery, equipment or articles that come into contact with food, it is recommended that their condition and consistency be controlled at the same time in point 2.3 and cleanliness in point 3.2.
- Production hygiene of packaging is controlled in point 5.5.
- Control is to be prioritised in the premises/establishments being controlled using a risk-based approach primarily on materials that come into contact with fatty foodstuffs and/or foodstuffs stored at high temperatures and/or for long periods of time.
- High production volumes/position of market leader of a foodstuff are also grounds for subjecting materials to risk-based control.
- 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”.
Matters to be controlled:
The implementation of own-check activities is evaluated by random checks (on e.g. 1-3 products, taking the scope and nature of operations into consideration) of compliance with requirements with respect to packaging and other food contact materials.
The following matters are to be controlled separately for each activity:
- The operator keeps the food grade quality and traceability of packaging materials, as well as new equipment, utensils and articles under control.
- Packaging and food contact materials are correctly used and any restrictions to use (e.g. using only packaging films, bags, containers and disposable gloves suitable for the purpose for fatty foodstuffs and foodstuffs sold or stored hot) are taken into consideration. Aluminium materials (e.g. pans, foils) are not used for acidic foodstuffs and steel utensils are not used with vessels made from aluminium.
- If the operator has noticed that regulatory requirements are not met, they have initiated adequate corrective actions.
1. Retail stores and catering facilities
- The control of packaging materials only covers packaging materials used by the store or facility itself.
- Packaging materials and other food contact materials are accompanied by either words that refer to food grade quality ("for food contact") or the glass and fork symbol. However, these are not obligatory for articles which are clearly intended to come into contact with foodstuff. As a rule, the glass and fork symbol can be considered adequate proof of the food grade quality of articles, provided their correct use has been verified; or
- The operator can present traceable declarations of compliance which state that the packaging materials and other food contact materials are suitable. If the packaging materials and other food contact materials have been procured from a wholesaler/central organisation and the commercial designation of the product indicates its intended purpose of use (e.g. barbecue bag, bread bag, cheese film), a certificate indicating the food contact use of the article or material need not be displayed in the store or catering facility. In this case it is enough that the certificate can be obtained from the wholesaler/central organisation, if necessary; and
- the operator is familiar with the correct use of packaging materials and other food contact materials and this is implemented in practical activities; and
- Food contact materials are traceable, i.e. the operator is able to demonstrate where the food contact materials were sourced and to estimate from the packaging materials the time during which they have been used/used in the food house.
- Operators who import (from the internal market and/or third countries) pre-packed foodstuffs: the fulfilment of the requirements laid down for food contact materials is also verified (e.g. included in the procurement contract or product specification).
2. Other food establishments
- The operator is able to present traceable declarations of compliance for packaging materials and other food contact materials, and the declarations are not too old (e.g. more than three years old).
- Declarations of compliance are not required of old equipment used in industrial manufacture, but some other information must be produced of their suitability. As a rule, the glass and fork symbol can be considered adequate proof of the food grade quality of articles, provided their correct use has been verified. Declarations of compliance provide adequate and appropriate information, e.g. at least:
- Name and contact information for the manufacturer, importer or trader of the food contact material
- Identification data on the contact material (name, construction)
- Date of issue of the declaration
- The legislation whose requirements the contact material meets (always at least Regulation (EC) 1935/2004) and also material-specific regulations, if any exist
[for example, for plastics data showing that the limit value of total migration is not exceeded; data on substances for which restrictions of use have been specified (always at least one of the following: FCM substance number, reference number, CAS number, chemical name, limit value) and a declaration that their limit values are not exceeded]. - Restrictions of use for contact materials, such as the food types which the contact material is suitable to be used with, restrictions related to temperature of use and time of contact
- Information about any dual use additives contained in the contact material.
- Small-scale operation: (when packaging materials and other food contact materials are procured from a cash and carry wholesaler or a retail store), comparable food grade quality requirements apply as above in points 1. Retail store and catering facility, sub-items 2, 3 and 4.
- Materials, articles, equipment and machinery are used in compliance with the instructions for use/suitability indicated in their declarations of compliance; taking into consideration, for example, suitable food groups, indicated temperature limits (filling and after-use) and times of contact, and that the possible migration of dual use additives meets the requirements laid down in provisions pertaining to additives and
- Food contact materials are traceable, i.e. the operator is able to demonstrate where the food contact materials were sourced and to estimate from the packaging materials the time during which they have been used/used in the food house.
- Operators who import (from the internal market and/or third countries) or broker pre-packed foodstuffs: the fulfilment of the requirements laid down for food contact materials is also under control (e.g. included in the procurement contract or product specification).
Operations comply with requirements.
Operation meets the aforementioned requirements. The operator has clear knowledge, and where necessary, adequate documents as regards the food grade quality of materials, and they are used correctly.
Food contact materials are traceable, i.e. the operator is able to demonstrate where the food contact materials were sourced and to estimate from the packaging materials the time during which they have been used/used in the food house.
There are small issues with the operations which do not impair food safety or mislead consumers.
1. Retail stores and catering facilities
Operation meets in the main parts the aforementioned requirements. The operator has knowledge about the suitability of most packaging materials, and uses articles accordingly. There are some minor shortcomings in operation, but notwithstanding these, the compliance of the use of the packaging and other food contact materials with requirements can be verified. For example:
- The majority of packaging materials and other food contact materials bear an indication referring to food contact use, or the operator has declarations of compliance for them. As concerns food contact materials that do not have this indication or a declaration of compliance, the operator has in some other way verified their suitability for the intended use in the order or procurement process.
- The suitability of the disposable gloves used to handle fatty foodstuffs has not been verified; for example, PVC (vinyl) gloves the labelling of which displays the glass and fork symbol, but there is no indication of suitability for use in contact with fatty foodstuffs.
- Food contact materials are mainly traceable, i.e. the operator is able to demonstrate where the food contact materials were mainly sourced and to estimate from the packaging materials the time during which they have been used/used in the food house.
2. Other food establishments
Operation meets in the main parts the aforementioned requirements. The operator has knowledge about the suitability of most packaging materials and food contact materials. There are some minor shortcomings in operation, but notwithstanding these, the compliance of the use of packaging and food contact materials with requirements can be verified. For example:
- The operator has valid declarations of compliance for most of the packaging materials and food contact materials. A small part of the declarations of compliance have inadvertently not been renewed, not been received yet or present deficient information. Small scale operation (articles procured from a cash and carry wholesaler or a retail store): the operator has comparable knowledge about the suitability of the materials they use.
- The suitability of the disposable gloves used to handle fatty foodstuffs has not been verified; for example, PVC (vinyl) gloves the labelling of which displays the glass and fork symbol, but there is no indication of suitability for use in contact with fatty foodstuffs.
There are issues with the operations which impair food safety or mislead consumers. These issues must be rectified within a set period of time.
1. Retail stores and catering facilities
The operator does not have adequate knowledge about the quality and suitability of the packaging materials and other materials they use, and has not made any attempt to verify these matters. There is cause to suspect that the materials used in the operations are not suitable for their purpose of use. For example:
- Packaging materials and other food contact materials do not bear an indication referring to food contact use, or the operator does not have declarations of compliance for them. The operator has failed to verify the suitability of the food contact material in any way in the order or procurement process and in fact has no knowledge about the suitability of the packaging and food contact materials.
- Fatty foodstuffs are handled wearing disposable gloves not suitable for the handling of fatty foodstuffs.
- Aluminium materials (e.g. pans, foils) are used for acidic foodstuffs and/or steel utensils are used with vessels made from aluminium.
- From a large proportion of contact materials, the operator has no knowledge of where they were acquired and she/he cannot estimate in what period they have been used, that is, the contact materials are not traceable.
- The operator is unable to demonstrate that the prepacked foodstuffs imported (from the internal market or third countries) or brokered by the operator meet the requirements laid down in food legislation also as regards their packaging materials (e.g. a statement in the procurement contract or product specifications).
2. Other food establishments
The operator does not have adequate knowledge about the quality and suitability of the packaging materials and other materials they use. For example:
- Declarations of compliance are missing for several of the materials used by the operator, or are clearly out-of-date (e.g. more than three years old) or contain completely deficient information, and the operator has not taken any action to get/renew them. Small scale operation (articles procured from a cash and carry wholesaler or a retail store): the operator does not have knowledge about the suitability of the majority of the articles they use.
- The packaging and food contact materials used in the operation are not suitable for their purpose of use or they are used in conditions for which they are not suitable (e.g. temperatures of use are too high compared with the temperatures indicated in the declaration of compliance, or food contact materials are used for food types for which they are not suitable, or the foodstuff does not meet the requirements laid down in provisions concerning additives, because of the migration of a dual use additive).
- From a large proportion of contact materials, the operator has no knowledge of where they were acquired and she/he cannot estimate in what period they have been used, that is, the contact materials are not traceable.
- The operator is unable to demonstrate that the prepacked foodstuffs imported (from the internal market or third countries) or brokered by the operator meet the requirements laid down in food legislation also as regards their packaging materials (e.g. a statement in the procurement contract or product specifications).
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.
1. Retail stores and catering facilities
It is obvious that food contact materials are used in a way that endangers food safety. The operator has no knowledge about the quality or suitability of the packaging materials and food contact materials they use, and has failed to take corrective actions despite being requested to do so, or the operator is aware of the defects in smell and taste caused to the product by the food contact material, but has failed to initiate a product recall process.
2. Other food establishments
It is obvious that food contact materials are used in a way that endangers food safety. The operator has no knowledge about the quality or suitability of the packaging materials and food contact materials they use, and has failed to take corrective actions despite being requested to do so.For example:
- The operator does not have any declarations of compliance for packaging and food contact materials. Small scale operation (articles procured from a cash and carry wholesaler or a retail store): the operator has not verified in any way the suitability of food contact materials (no certificates, no glass and fork symbol, not indicated in the name or by the nature of the article.)
- The operator is aware of the defects in smell and taste caused to the product by the packaging material or other food contact material, but has failed to initiate a product recall process.
Legislation and guidelines (with any amendments) pertaining to the subject:
- Regulation of the European Parliament and of the Council on materials and articles intended to come into contact with food (EC) No 1935/2004
- Finnish Food Act 297/2021
- Commission Regulation on plastic materials and articles intended to come into contact with food (EU) No 10/2011
- Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food
- Commission Regulation (EU) No 284/2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China
- Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food
- Finnish Degree (KTM) 165/2006 on ceramic materials and articles intended to come into contact with food (dir. 2005/31/EY, 84/500/ETY)
- Finnish Degree (KTM) 697/2005 on regenerated cellulose materials and articles intended to come into contact with food (dir 2004/14/EY)
- Finnish decision 268/1992 (KTM) on heavy metals migrating from food contact materials
- Ruokavirasto’s Guide for control of food contact materials, No 4217/04.02.00.01/2021.
Updates in version 9:
- Updated the traceability sections of assessment Guide.
- The number of the instruction has been changed to correspond to the numbering of the Finnish version.