These instructions have been drawn up to ensure the safety of steam that comes into contact with foodstuffs in food establishments, and the compliance of chemicals, or so-called steam boiler chemicals, used in the formation of steam to prevent the rusting of the appliances used.
Requirements for steam and steam boiler chemicals
- The EU general regulation on food hygiene (No 852/2004, Annex II, Chapter VII, Article 5) lays down general requirements on steam that is in direct contact with foodstuffs. Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food. Steam boiler chemicals must meet the requirements of chemical legislation. The Ministry of Social Affairs and Health Decree No. 807/2001 (latest amendment 6/2010) on the classification principles and labelling of chemicals divides hazardous chemicals into the following classifications: substances that are extremely toxic, toxic, harmful, corrosive, irritant, sensitising, carcinogenic, mutagenic, and toxic to reproduction. Monitoring of compliance with the requirements of chemicals legislation is the responsibility of the Finnish Safety and Chemicals Agency (Tukes).
- Chemicals that easily evaporate during a process are the most relevant with respect to foodstuffs. Particular care must be taken to ensure that steam boiler chemicals do not contain so-called CMR substances, which may be carcinogenic, mutagenic or toxic for reproduction.
- In addition to the above chemical classification status, compliance with the hygiene decree, as a key principle of food safety, must include
- Compliance with EU regulations or official recommendations, in the first instance, or, in the absence of such regulations or recommendations
- compliance with the requirements of a Member State regulation or official recommendation or
- compliance with guidelines and standards governing the industry and the chemicals in question within the EU or
- compliance with the laws of non-EU countries (e.g. USA’s FDA regulations).
Responsibilities of suppliers of steam boiler chemicals
A manufacturer of steam boiler chemicals must be able to demonstrate its principles for the safe use of the chemical in food production. In addition to compliance with the labelling obligations (including instructions for use) required by chemicals legislation, food business operators must, upon request, be provided with food safety information about the steam boiler chemical, to demonstrate that, for example, the general requirements of the above hygiene decree have been met.
The food business operator must also be provided with information on the composition of the steam boiler chemical to the extent necessary to risk assessment performed by the operator (e.g. information on food additives contained in the chemical, and on substances that may vaporise during a process).
Information, including safety information of this kind, should be provided to the food business operator in a separate document (electronic or paper), not just by e-mail, for example, and the supplier of the steam boiler chemical should commit to providing a new document if changes occur in the chemical composition or safety classification.
Responsibilities of the food business operator
The EU general regulation on food hygiene (No 852/2004, Annex II, Chapter V, Article 3) also lays down principles on chemical additives used to prevent the rusting of equipment and storage tanks in food establishments, in regard of which chemicals used in steam boilers can be classified. They must be used in accordance with good practice. In practice, this means that such chemicals should only be used in quantities that achieve the desired effect, and the dosage restrictions of the steam boiler chemical manufacturer must be observed. The food business operator is responsible for ensuring compliance with good practices in a food establishment.
The food business operator must ensure the safety of the steam boiler chemical, with regard to the foodstuff, before accepting the chemical for its intended use. The purpose of the steam boiler chemical determines whether any specific legislation should be followed in addition to the general legislation on foodstuffs.
The food business operator should be aware of the use of steam boiler chemicals and evaluate the chemical hazards and risks posed to the foodstuff to be produced from steam boiler chemicals, through the risk assessment procedures forming part of the operator’s own checks. During such risk assessment, the food business operator must investigate and consider the following issues, among others
- Is the use of steam boiler chemicals indispensable and why is it necessary? What is the primary purpose of using steam boiler chemicals? Does the steam boiler chemical have other, secondary uses, such as affecting the quality or preservation of the food?
- What is the minimum amount that would still have the desired effect? Are the principles of good practice applied to dosages?
- What substances do steam boiler chemicals contain? What impact will any chemical transferred to a foodstuff from steam have on the foodstuff? Do the substances contain ingredients that are also used as additives or processing agents in food production?
- What kinds of substances will potentially be transferred into the food? Is the food safe and compliant with legal requirements, despite the transfer of such chemicals?
- If the steam boiler chemical contains food additives or processing agents, do the substances have some technological function in the food being produced?
- If there is a technological effect, is the food produced still safe and compliant with the applicable legislation? Does the transferred additive comply with the requirements of additive legislation in terms of its purity (EU Regulation 231/2012) and the amount transferred (EC Regulations 1333/2008 and 889/2008)?
- Should the use of additives or processing agents be indicated on the food’s labelling?
The ‘own-check’ measures of the food business operator also include regular monitoring to ensure that the steam boiler chemical is used in the correct dosages. If a risk assessment indicates or raises doubts that the additives contained in a steam boiler chemical could have a technological effect on a foodstuff, the concentration of additives or processing agents in foodstuffs should, if necessary, be investigated. In some cases, vaporising substances may also be tested from condensate water.