Control frequency determination

Risk classification for contact material operations

Evira has composed guidelines for defining risk classification and need for monitoring in food establishments and in food contact material operations (guideline 10503). The guidelines are being updated, and the risk classification for food contact material operations will become more specific. Evira 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 national 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 national 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 15–100

  • Turnover 2–10 million euros / year

Risk classification 3 – very large-scale national or international 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.

Furthermore, the risk classification is elevated if the operations include manufacturing/processing or the contact materials are intended for small children (e.g. baby bottles, baby food packaging). Small ceramics shops are automatically categorised under risk classification 1, even though their operations include manufacturing. 

Example 1: The establishment has 2 material qualities, their production volume is 10 million 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 < €2 million / 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.

 

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.