Risk classification for contact material operations
Finnish Food Authority has composed guidelines for defining risk classification and need for monitoring in food establishments and in food contact material operations (guideline). The guidelines are being updated, and the risk classification for food contact material operations will become more specific. Finnish Food Authority has already recommended applying the specifications to the municipal food control units, because it makes defining control frequency for establishments easier and presents clearer guidelines, which promotes equal treatment of food contact material operators around Finland.
Food contact materials for food fall under class 2 in the risk classification instructions. Under it, there are three actual risk classifications, and their control frequencies are 0.35 times per year, 0.5 times per year and 1 time per year.
When the risk classification instructions are updated, the verbal risk classification descriptions will be abandoned. Information about the extent belong under basic information in the notification about operations (EL 23/2006 21a§).
Statistics about the extent of the contact material operations are the following:
Risk classification 1 – small or medium-scale food contact material business
- Material qualities 1–3
- Production volume < 100 pcs/year, < 10,000 kg/year
- Floor area of production and storage facilities < 100 m2
- Staff volume < 15
- Turnover < 2 million euros / year
Risk classification 2 – large-scale tood contact material business
- Material qualities 4–8
- Production volume 100–1,000 pcs/year, 10,000–1 million kg/year
- Floor area of production and storage facilities 100–500 m2
- Staff volume 15–100Turnover 2–10 million euros / year
Risk classification 3 – very large-scale food contact material business
- Material qualities > 8
- Production volume > 1000 pcs/year, > 1 million kg/year
- Floor area of production and storage facilities > 500 m2
- Staff volume > 100
- Turnover > 10 million euros / year
If a business fulfils three criteria of a certain classification, that classification is chosen for it. If three criteria are fulfilled in none of the classifications, the appropriate classification is chosen based on the amount of material qualities.
If the ranges include food contact materials intended for small children (e.g. baby bottles, baby food packaging, etc.) the risk classification is always 2 or 3.
Also, if operations include manufacturing, the risk classification is, as a rule, elevated by one, for example, from risk classification 1 to risk classification 2 and from risk classification 2 to risk classification 3.
Relief from the fee for control and regular inspection for small-scale and low-risk FCM operations
Small-scale and low-risk FCM operations are exempt from the control service charge and from regular inspections of operations. NB! They are still subject to registration notification to the municipal food control authority, please refer to the guidance in section 5. Moreover, the municipal food authority must provide them with advice and guidance as necessary.
Where the operations of a business come under risk classification 1 in respect of all criteria and the annual turnover of food contact materials is below the turnover threshold for VAT purposes, the concept of small-scale FCM operations applies to low-risk FCM operations, such as to the following operations:
- artisanal businesses such as small pottery workshops, metal workshops and workshops making articles from wood,
- cutting FCM into sheets, i.e. small-scale processing of FCM which does not involve printing,
- small-scale internal market imports and wholesale
Third-country imports or operations which involve printing with printing inks cannot be considered as being low risk, which means that the relief from the fee for control does not apply to such operations. More information on the fee for control can be found in the Finnish Food Authority guide (add link).
Examples of risk classification, inspection frequency and determination of the fee for control:
Example 1: The establishment has 2 material qualities, their production volume is 10m kg/year, floor area of production and storage facilities is 70 m2, staff volume is 5 and turnover is €5 million/year; the appropriate risk classification is 1. However, because the business includes manufacturing, the classification is elevated by one, so the final risk classification is 2.
Example 2 The establishment has 5 material qualities, their production volume is 1,500 pcs/year, staff volume is 14, floor area of production and storage facilities is 200 m2 and turnover is < €2m/year; none of the risk classifications is chosen because three criteria are not fulfilled. Therefore, risk classification 2 is chosen based on the number of material qualities.
Example 3: Small-scale metal workshop or pottery workshop. All the information describing the nature and scope of operations used in classification of the site complies with risk classification 1. In addition, the annual turnover of food contact materials is below the turnover threshold for VAT purposes, even though manufacturing is involved. No fee for control is charged and no regular inspections are made. Inspections are made as necessary.
Example 4. Small-scale printing and stamping of cardboard boxes. All the information describing the nature and scope of operations used in classification of the premises complies with risk classification 1. In addition, the annual turnover of contact materials is below the turnover threshold for VAT purposes. The risk classification 1 is chosen. A fee for control is charged because operations include printing with printing inks. Regular inspection is carried out at least every three years.
The operator must provide information about the scale of operations as part of the basic information in the notification of operations and the information is checked in conjunction with inspections to ensure they are up to date. The inspection frequency in risk classifications varies: in risk classification 1 it is 0.35 times a year, in risk classification 2 it is 0.5 times a year and in risk classification 3 it is once a year. The inspection frequency in risk classifications varies and may be 0.35, 0.5 times or once a year.
Contact material control frequency in food establishments
The safety and regulatory compliance of contact materials is also controlled as a part of the usual food establishment monitoring. During inspections in approved and registered food establishments, the instruction 14.1 for an Oiva inspection is followed. The inspections are made based on risks and depending on the control frequency of the food establishment; however, contact materials must be inspected at least three times a year.