- Email: [email protected]
Food Grade Gas Regulation
C H A P T E R
5 Food Grade Gas Regulation Philippe Girardon Air Liquide, Paris, France
5.1 GLOSSARY • HACCP ¼ Hazard Analysis and Control of Critical Points • ISBT ¼ International Society of Beverage Technologists • GFSI ¼ Global Food Safety Initiative • FSMS ¼ Food Safety Management System • ISO 22000 standard covers all the food safety aspects • FSSC 22000 combines ISO 22000 + (HACCP + hygiene practices) PAS 220 • BSI(*) PAS(**) 220:2008 Prerequisite programs on food safety for food manufacturing *British Standards Institution is owner of **Publicly Available Specification • EC ¼ European Community • EU ¼ European Union • BRC ¼ British Retail Consortium • IFS ¼ International Featured Standards • Dutch HACCP • EIGA ¼ European Industrial Gases Association • CGA ¼ Compressed Gases Association (United States) € ¼ Technischer Uberwachungs-Verein € • TUV • EN ¼ European Norms
Gases in Agro-food Processes https://doi.org/10.1016/B978-0-12-812465-9.00011-6
• AFNOR ¼ French Normalization Organization
5.2 INTRODUCTION The basis of European food legislation is regulation (EC) 178/2002 of the European Parliament and of the Council of January 28, 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety. Current and proposed European legislation requires that foods, including gases supplied to the food industry, must meet increasingly rigorous standards to ensure food safety. Gases are used for a variety of purposes in the food and beverage industry, which may include being used as additives, processing aids, or ingredients. In particular, they have to meet requirements regarding labeling, purity criteria, and hygiene. Food gases are defined as gases in liquid, gaseous, or solid form that are supplied to the food and beverage industry. These include gases for modified atmosphere packaging, liquid nitrogen and solid carbon dioxide for freezing and chilling, gaseous carbon dioxide for beverage carbonation, and several other applications. They may be
121
# 2019 Elsevier Inc. All rights reserved.
122
5. FOOD GRADE GAS REGULATION
delivered as refrigerated liquid gases, under compressed gas cylinders in different formats, generated onsite at the user’s premises, or, in the case of carbon dioxide, as solid dry ice made at gas company plants or at the customer’s premises. In detail, the principal uses of food gases are the following:
Regulation EC/1935/2004 covering food contact materials compliance. Regulations EC/2073/2005 + 1441/2007 covering microbiological criteria on foods. Regulation EC/1107/2009 regarding plant protection products. Directive EC/528/2012 regarding biocides.
a. Additives
Several other European directives cover allergens and organic food that can also be of concern for food-grade gases. Independently of the European regulations and those on other continents, standards and norms can be substituted for regulations when these do not exist or are not sufficiently clear for proper application, for example, ISO, TUV, AFNOR, and CEN standards. Not considered as beverage but drinked by humans, we can mention the CO2 for drinking water standard EN 936 published in December 2013 falling in this case of substitution to regulation regarding specification of CO2. This molecule is used for treating water hardness and pH adjustment and for regeneration of ion exchange resins. Standards certifications have been entered in force by the retail sector, adding to food safety requirements in addition to the local legislation. We mention BRC, IFS, and Dutch HACCP. To obtain certification according to the mentioned categories (e.g., ISO, BRC), audits in food and beverage companies, including industrial gas companies, are done by appointed bodies such as Bureau Veritas or SGS. We must also mention the guidelines written by professional associations from different sectors that can impact food-grade gas compliance with their recommendations. One important organization covering the beverage industry is the International Society of Beverage Technologists (ISBT), which publishes guidelines covering different parts of beverage manufacturing. Among these, nitrogen and carbon dioxide are subject to dedicated documents covering procedures for the gas supply chain, delivery, specification, testing, analytical impurity measurement protocols, etc. (see the chapter on Risk Assessment).
Oxygen, nitrogen, argon, and carbon dioxide as modified atmosphere packaging gases; nitrogen, nitrous oxide, and carbon dioxide as propellant gases for whipped cream; sulfur dioxide as a preservative for specified foods and wine making. b. Processing Aids Liquid nitrogen and liquid carbon dioxide for freezing, chilling, and temperature control; Supercritical carbon dioxide for molecule extraction; hydrogen for hydrogenation of fats and starch products; nitrogen, argon, and carbon dioxide for inerting of bulk materials under solid and liquid forms. c. Ingredients Carbon dioxide for carbonated beverages.
5.3 LEGISLATION AND STANDARDS REGARDING FOODGRADE GASES In Europe, the food-grade gases must follow legislation in the main following areas: Directive EC/2008/84 covering specific purity criteria of food additives. Regulation EC/178/2002—Food law covering hygiene and food safety requirements, including use of hazard analysis and critical control points (HACCP), labeling, lot marking, and traceability. Regulation EC/852/2004 covering hygiene of foodstuffs. EC/1333/2008—Food additives and labeling.
5. REGULATION
5.4 MAIN FOOD GAS CONCERNS VS EU REGULATION
5.4 MAIN FOOD GAS CONCERNS VS EU REGULATION In Europe, the main following molecules are authorized in the agrofood sector: nitrogen, oxygen, carbon dioxide, argon, hydrogen, nitrous oxide, helium, sulfur dioxide, and ethylene, according to their biological, chemical, and physical properties under different states of delivery and process applications. Also according to the different sectors, specific regulations need to register the molecules to get approval and authorization for use. These are subject to renewal after an approximate period of 10–14 years. If the major use of food gases is related to Nitrogen, Carbon Dioxide and Oxygen, that are common, Agro-Food industry is also using minor molecules for specific and unusual applications as following: ethylene concerns some fruits ripening, for example, green Banana, citrus de-greening in storing chambers or tomato ripening in greenhouses, ozone (O3) as a biocide active substance for sterilization or CO2 as pest control agent. Note that carbon monoxide (CO) is banned for coloration of meats and fish in modified atmosphere packaging (MAP) across Europe, although this is not the case in the United States, Canada, Australia, and South America. In the United States, legislation is open for the cases of O3 generally recognized as safe (GRAS) such as CO, even if this last one creates debates. In other geographies, we have intermediary legislation mixing European and American standards. As an example, we note the case of Directive EC/528/2012 regarding biocides and particularly precursors of active substances. The companies placing on the market or using biocidal products generating active substance(s) are falling within the scope of the EU Biocidal Products Regulation (BPR); we can mention the following substances: • Ozone generation from oxygen in the atmosphere.
123
• Ozone generation from pure oxygen. • Electrolysis of seawater forming hypochlorous acid. • Electrolysis of sodium chloride forming hypochlorous acid. • Electrolysis of sodium chlorite generating chlorine dioxide. • Combustion of butadiene generating CO2. • Nitrogen generation (concentration) from air to create a deoxygenated environment. • Oxygen scavengers to create a deoxygenated environment. In this case, authorization dossiers have to be filled by the users or the sellers. A similar case happens with Regulation EC/ 1107/2009 regarding plant protection products concerning CO2 as a pesticide agent and ethylene as a ripening agent. One of the roles of the gas professional associations is to highlight the different regulations by drafting some guidance for industrial gas companies and users. In this domain, the European Industrial Gases Association (EIGA) is a safety and technically oriented organization representing the vast majority of European companies as well as many non-European companies producing and distributing industrial, medical, and food gases. EIGA is an international nonprofit organization (AISBL). The member companies closely cooperate in safety and technical matters concerning production, transport, storage, and application to achieve the highest level of safety and environmental care in the handling of gases. EIGA also initiates the development of appropriate standards and provides standardization bodies with technological expertise. EIGA fully cooperates with all national and regional industrial gas associations around the world, such as AIGA (Singapore), ANZIGA (Australia/New Zealand), CGA (United States), JIMGA (Japan), and SACGA (South Africa), which are all associated members of EIGA.
5. REGULATION
124
5. FOOD GRADE GAS REGULATION
The main documentation in the public domain can be read at the following link: https://www.eiga.eu/publications/eigadocuments/. It has the most relevant information on safety and food safety regulation. The main documents published related to food and beverages are listed as the following, which are subject to periodic updates: Guidelines for the safe installation and use of cryogenic food freezing and cooling equipment. Guide to the supply of food gases for use in food. Minimum specifications for food gas applications (EU). Materials and articles intended to come into contact with food. Carbon monoxide in modified atmosphere packaging of meat and fish, reminding of banishment in the UE. Carbon dioxide source qualification. Cryogenic nitrogen in molecular cooking.
Safe design and operation of onsite N2 generators for food use. Note that in each European country, there is a local industrial gas association that declines EIGA documentation in its proper language or creates its own specific documentation.
5.5 CONCLUSION Compliance with regulation, norms, or standards is part of the food business activities: sourcing, manufacturing, supply chain, and distribution to inform the consumer and to prevent making anyone sick. The food gases do not escape from these constraints, although no real hazards have been identified during their process risk assessments.
Reference https://www.eiga.eu/publications/eiga-documents/.
5. REGULATION
5 Food Grade Gas Regulation Philippe Girardon Air Liquide, Paris, France
5.1 GLOSSARY • HACCP ¼ Hazard Analysis and Control of Critical Points • ISBT ¼ International Society of Beverage Technologists • GFSI ¼ Global Food Safety Initiative • FSMS ¼ Food Safety Management System • ISO 22000 standard covers all the food safety aspects • FSSC 22000 combines ISO 22000 + (HACCP + hygiene practices) PAS 220 • BSI(*) PAS(**) 220:2008 Prerequisite programs on food safety for food manufacturing *British Standards Institution is owner of **Publicly Available Specification • EC ¼ European Community • EU ¼ European Union • BRC ¼ British Retail Consortium • IFS ¼ International Featured Standards • Dutch HACCP • EIGA ¼ European Industrial Gases Association • CGA ¼ Compressed Gases Association (United States) € ¼ Technischer Uberwachungs-Verein € • TUV • EN ¼ European Norms
Gases in Agro-food Processes https://doi.org/10.1016/B978-0-12-812465-9.00011-6
• AFNOR ¼ French Normalization Organization
5.2 INTRODUCTION The basis of European food legislation is regulation (EC) 178/2002 of the European Parliament and of the Council of January 28, 2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety. Current and proposed European legislation requires that foods, including gases supplied to the food industry, must meet increasingly rigorous standards to ensure food safety. Gases are used for a variety of purposes in the food and beverage industry, which may include being used as additives, processing aids, or ingredients. In particular, they have to meet requirements regarding labeling, purity criteria, and hygiene. Food gases are defined as gases in liquid, gaseous, or solid form that are supplied to the food and beverage industry. These include gases for modified atmosphere packaging, liquid nitrogen and solid carbon dioxide for freezing and chilling, gaseous carbon dioxide for beverage carbonation, and several other applications. They may be
121
# 2019 Elsevier Inc. All rights reserved.
122
5. FOOD GRADE GAS REGULATION
delivered as refrigerated liquid gases, under compressed gas cylinders in different formats, generated onsite at the user’s premises, or, in the case of carbon dioxide, as solid dry ice made at gas company plants or at the customer’s premises. In detail, the principal uses of food gases are the following:
Regulation EC/1935/2004 covering food contact materials compliance. Regulations EC/2073/2005 + 1441/2007 covering microbiological criteria on foods. Regulation EC/1107/2009 regarding plant protection products. Directive EC/528/2012 regarding biocides.
a. Additives
Several other European directives cover allergens and organic food that can also be of concern for food-grade gases. Independently of the European regulations and those on other continents, standards and norms can be substituted for regulations when these do not exist or are not sufficiently clear for proper application, for example, ISO, TUV, AFNOR, and CEN standards. Not considered as beverage but drinked by humans, we can mention the CO2 for drinking water standard EN 936 published in December 2013 falling in this case of substitution to regulation regarding specification of CO2. This molecule is used for treating water hardness and pH adjustment and for regeneration of ion exchange resins. Standards certifications have been entered in force by the retail sector, adding to food safety requirements in addition to the local legislation. We mention BRC, IFS, and Dutch HACCP. To obtain certification according to the mentioned categories (e.g., ISO, BRC), audits in food and beverage companies, including industrial gas companies, are done by appointed bodies such as Bureau Veritas or SGS. We must also mention the guidelines written by professional associations from different sectors that can impact food-grade gas compliance with their recommendations. One important organization covering the beverage industry is the International Society of Beverage Technologists (ISBT), which publishes guidelines covering different parts of beverage manufacturing. Among these, nitrogen and carbon dioxide are subject to dedicated documents covering procedures for the gas supply chain, delivery, specification, testing, analytical impurity measurement protocols, etc. (see the chapter on Risk Assessment).
Oxygen, nitrogen, argon, and carbon dioxide as modified atmosphere packaging gases; nitrogen, nitrous oxide, and carbon dioxide as propellant gases for whipped cream; sulfur dioxide as a preservative for specified foods and wine making. b. Processing Aids Liquid nitrogen and liquid carbon dioxide for freezing, chilling, and temperature control; Supercritical carbon dioxide for molecule extraction; hydrogen for hydrogenation of fats and starch products; nitrogen, argon, and carbon dioxide for inerting of bulk materials under solid and liquid forms. c. Ingredients Carbon dioxide for carbonated beverages.
5.3 LEGISLATION AND STANDARDS REGARDING FOODGRADE GASES In Europe, the food-grade gases must follow legislation in the main following areas: Directive EC/2008/84 covering specific purity criteria of food additives. Regulation EC/178/2002—Food law covering hygiene and food safety requirements, including use of hazard analysis and critical control points (HACCP), labeling, lot marking, and traceability. Regulation EC/852/2004 covering hygiene of foodstuffs. EC/1333/2008—Food additives and labeling.
5. REGULATION
5.4 MAIN FOOD GAS CONCERNS VS EU REGULATION
5.4 MAIN FOOD GAS CONCERNS VS EU REGULATION In Europe, the main following molecules are authorized in the agrofood sector: nitrogen, oxygen, carbon dioxide, argon, hydrogen, nitrous oxide, helium, sulfur dioxide, and ethylene, according to their biological, chemical, and physical properties under different states of delivery and process applications. Also according to the different sectors, specific regulations need to register the molecules to get approval and authorization for use. These are subject to renewal after an approximate period of 10–14 years. If the major use of food gases is related to Nitrogen, Carbon Dioxide and Oxygen, that are common, Agro-Food industry is also using minor molecules for specific and unusual applications as following: ethylene concerns some fruits ripening, for example, green Banana, citrus de-greening in storing chambers or tomato ripening in greenhouses, ozone (O3) as a biocide active substance for sterilization or CO2 as pest control agent. Note that carbon monoxide (CO) is banned for coloration of meats and fish in modified atmosphere packaging (MAP) across Europe, although this is not the case in the United States, Canada, Australia, and South America. In the United States, legislation is open for the cases of O3 generally recognized as safe (GRAS) such as CO, even if this last one creates debates. In other geographies, we have intermediary legislation mixing European and American standards. As an example, we note the case of Directive EC/528/2012 regarding biocides and particularly precursors of active substances. The companies placing on the market or using biocidal products generating active substance(s) are falling within the scope of the EU Biocidal Products Regulation (BPR); we can mention the following substances: • Ozone generation from oxygen in the atmosphere.
123
• Ozone generation from pure oxygen. • Electrolysis of seawater forming hypochlorous acid. • Electrolysis of sodium chloride forming hypochlorous acid. • Electrolysis of sodium chlorite generating chlorine dioxide. • Combustion of butadiene generating CO2. • Nitrogen generation (concentration) from air to create a deoxygenated environment. • Oxygen scavengers to create a deoxygenated environment. In this case, authorization dossiers have to be filled by the users or the sellers. A similar case happens with Regulation EC/ 1107/2009 regarding plant protection products concerning CO2 as a pesticide agent and ethylene as a ripening agent. One of the roles of the gas professional associations is to highlight the different regulations by drafting some guidance for industrial gas companies and users. In this domain, the European Industrial Gases Association (EIGA) is a safety and technically oriented organization representing the vast majority of European companies as well as many non-European companies producing and distributing industrial, medical, and food gases. EIGA is an international nonprofit organization (AISBL). The member companies closely cooperate in safety and technical matters concerning production, transport, storage, and application to achieve the highest level of safety and environmental care in the handling of gases. EIGA also initiates the development of appropriate standards and provides standardization bodies with technological expertise. EIGA fully cooperates with all national and regional industrial gas associations around the world, such as AIGA (Singapore), ANZIGA (Australia/New Zealand), CGA (United States), JIMGA (Japan), and SACGA (South Africa), which are all associated members of EIGA.
5. REGULATION
124
5. FOOD GRADE GAS REGULATION
The main documentation in the public domain can be read at the following link: https://www.eiga.eu/publications/eigadocuments/. It has the most relevant information on safety and food safety regulation. The main documents published related to food and beverages are listed as the following, which are subject to periodic updates: Guidelines for the safe installation and use of cryogenic food freezing and cooling equipment. Guide to the supply of food gases for use in food. Minimum specifications for food gas applications (EU). Materials and articles intended to come into contact with food. Carbon monoxide in modified atmosphere packaging of meat and fish, reminding of banishment in the UE. Carbon dioxide source qualification. Cryogenic nitrogen in molecular cooking.
Safe design and operation of onsite N2 generators for food use. Note that in each European country, there is a local industrial gas association that declines EIGA documentation in its proper language or creates its own specific documentation.
5.5 CONCLUSION Compliance with regulation, norms, or standards is part of the food business activities: sourcing, manufacturing, supply chain, and distribution to inform the consumer and to prevent making anyone sick. The food gases do not escape from these constraints, although no real hazards have been identified during their process risk assessments.
Reference https://www.eiga.eu/publications/eiga-documents/.
5. REGULATION