{"id":30740,"date":"2021-07-30T09:51:48","date_gmt":"2021-07-30T07:51:48","guid":{"rendered":"https:\/\/www.hiperbaric.com\/tecnologia-hpp-cumplimiento-normativo-alrededor-del-mundo\/"},"modified":"2021-08-03T09:57:51","modified_gmt":"2021-08-03T07:57:51","slug":"hpp-technology-global-regulatory-compliance","status":"publish","type":"post","link":"https:\/\/www.hiperbaric.com\/en\/hpp-technology-global-regulatory-compliance\/","title":{"rendered":"HPP Technology: Global Regulatory Compliance"},"content":{"rendered":"

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HPP is a technology that has been commercialized for 30 years all over the world with no history of product recall or consumer health concern. Although HPP is quite flexible and it can be successfully applied to a wide range of food sectors, there are no specific regulations across all of the different HPP products or countries. Aware of the ambiguity and importance of this topic for food safety, in this blog you will learn how HPP products can achieve regulatory compliance around the world.<\/strong><\/p>\n

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Regulatory compliance in North America<\/h2>\n

Although the first companies using HPP in the 1990s were based in Asia or Europe, 47 % of the global HPP equipment now corresponds to North America, specifically the United States, Canada, and Mexico, making this region the most advanced in terms of commercialized food products.<\/p>\n

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Figure 1. Worldwide distribution of HPP machines per geographical zone.<\/figcaption><\/figure>\n

HPP has been approved as a lethality process for pathogen inactivation and shelf-life extension by renowned organizations, such as FDA, USDA and FSIS. In this sense, consulting their upstanding regulations for food safety compliance is mandatory.<\/p>\n

For example, the Food Safety Modernization Act (FSMA)<\/a> highlights the importance of prevention rather than being reactive in terms of food safety. In this regard, this generic guidance identifies HPP as a preventive control in chapters 4 and 5.<\/p>\n

Going to more specific food sectors such as juices<\/a>, RTE-meals<\/a>, and pet food<\/a>, the FDA has established some guidance documents for the industry, pointing out the need for process validation for the commercialization of HPP products; namely, pressure level and holding time will be the critical parameters that need to be validated if a food business relies on HPP to control the target pathogens in their food products.<\/p>\n

Therefore, as a step that inactivates microorganisms, HPP needs to be included in the HACCP plan, but in this case only for vegetative bacteria (and mold spores), not bacteria in a spore state. That\u2019s why juices or other food products with a pH of 4.6 or higher must incorporate additional control measures to account for Clostridium botulinum<\/em> spores.<\/p>\n

Regulatory compliance in the European Union<\/h2>\n

After North America, Europe represents the second largest HPP market in the world, with 25% of the HPP units installed in this region.<\/p>\n

Since 2018, at the EU level, HPP is no longer considered a novel process. It does not need EU Novel Food Authorization just because of the use of HPP, i.e. without notification on certain conditions of use, HPP is assumed to be authorized.<\/a><\/p>\n

Therefore, the best way to comply within this region will be to follow the general EU food safety and packaging regulations, including:<\/p>\n

–EU Regulation 2073\/2005<\/a> on microbiological criteria for food safety. According to this regulation, the final product must meet the following criteria:<\/p>\n

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Figure 2. Microbiological criteria for foodstuffs.<\/figcaption><\/figure>\n

–EU Regulation 10\/2011<\/a> on plastic materials intended to come into contact with food. Only the plastic materials authorized by this regulation can be used for food contact. In addition, packaging migration limits for some materials set by the same regulation must be met.<\/p>\n

Regulatory compliance in Asia<\/h2>\n

HPP machines can also be found in Asia as the region accounts for 17% of HPP machines, mainly installed in China, South Korea, Japan, and Thailand.<\/p>\n

In Asia, food manufacturers will need to take the following steps for the safe and successful commercialization of HPP products:<\/p>\n

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Seg\u00fan la regi\u00f3n de comercializaci\u00f3n, se pueden considerar cuatro escenarios diferentes:<\/p>\n

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  1. Asian product for its domestic market:
    \nSince there are no specific regulations for HPP products, the rule will be to comply with the domestic regulation according to the product category enforced in this country.<\/li>\n
  2. Asian product exported to another Asian country:
    \nSimilar to the previous case, food manufacturers must comply with domestic regulations enforces in the country where the product will be exported and commercialized.<\/li>\n
  3. Asian product exported to USA or the EU:
    \nHPP foods and beverages sold in the USA or the EU must comply with USA FDA\/FSIS\/USDA regulation or EU general food safety regulations, respectively. In addition, if the company is a member of the <\/span>    Cold Pressure Council<\/a>, compliance with <<High Pressure Certified>> requirements will allow the company to place the <\/span><<High Pressure Certified>> logo<\/a> on the product package.<\/span>