Best one wins – FDA food safety regulation

6 April 2017



Incoming legislation from the FDA focused on food modernisation and safety, and new guidelines being formulated in Europe, have thrown the spotlight once again on food safety. How will the industry respond to this evolution in regulation?


From raw ingredients suppliers to packaging companies, food safety is at the top of everyone's agenda. Regulatory changes certainly bring challenges for food companies and their packaging partners. The US Food and Drug Administration (FDA)'s 2011 Food Safety Modernization Act (FSMA), and it is now at the enforcement stage. This aims to address contamination and will have a significant impact on standards in the UK and in the European Union, and the European Food Safety Agency (EFSA) is working on new guidance on how to assess the safety of food-contact materials.

“You don’t eat the packaging, you eat the food,” remarks Jürgen Towara, senior food contact expert and head of food contact consultancy in Europe for global quality assurance provider Intertek. “That is what should be kept in mind when working on food packaging materials compliance. Regulatory information is updated periodically and imposes more specific restrictions because the science backing up food contact regulatory has developed immensely, and there is a better understanding about what is dangerous and what is not.

“This permanent updating and optimising of standards, recommendations and regulations seems burdensome to some of the stakeholders because it must be followed up and implemented. However, it also can be seen as a valid tool to support the risk assessment of the produced material to show that products are safe.

“As an example, a regulatory limit laid down on the allowed list of substances of a regulation of reflects a daily intake of a substance of the whole lifetime of person without any harm to health. The acknowledged limit for non-detection of migration from packaging into food lies at ten parts per billion (ppb) meaning that a substance is not present in the food at this limit.

“When standards are updated, the impact on the industry depends on the size of enterprises being involved in the food producing value chain. While big firms are able to keep abreast of new restrictions, smaller enterprises often lack the manpower to follow up on them, and therefore use third-party consultancies and laboratories.”

Rewriting the rules

The understanding of migration risks from packaging is constantly evolving. New research always grabs the headlines, and among the latest is a study from a team at Université Paris-Saclay that suggests suggests that the contamination of aqueous food by aromatic compounds originating from packaging materials might have been underestimated. The team proposes a new method for calculating the extent to which some substances in packaging might dissolve, and to examine the migration rate of substances such as endocrine-disrupting chemicals.

The report further suggests that the new methodology, devised by Université Paris-Saclay partners INRA and AgroParisTech, should be employed to re-evaluate all materials that come into contact with food.

“Contamination of food is a concern,” says Olivier Vitrac from INRA, “and regulations are supposed to be strict about this. Previously collected data and this study suggest that the real chemical affinity of substituted aromatic compounds for water could be strongly underestimated by previous oversimplified rules and that tailored methods, such as this one, would be preferable. The industry needs to address today’s loose, outdated food packaging rules as soon as possible.”

Food companies acknowledge the importance of regulations and the need to retain food safety as a high priority.

“Mondelez International knows that its growth depends on ensuring the safety of its people and products, says the company's vice-president of quality, food safety and scientific and regulatory affairs, Frank Sabella. That’s why safety is one of the pillars of its Call For Well-being platform. This includes safety, as well as well-being snacks, sustainability, and community partnerships.

“People are also interested in the ingredients Mondelez uses, and how they are sourced. Its sustainable agriculture programmes help create a sustainable supply of critical raw materials and ensure their integrity. It also has strong food safety systems and state-of-the-art safeguards to ensure the quality and safety of ingredients.”

The strategy that Mondelez is taking encompasses its partners in the supply chain and, therefore, influences the choices made for the packaging of its products.

“The company expects its suppliers and external manufacturers worldwide to live up to the same strict standards it has set for itself and requires them to meet well-defined safety and quality expectations,” says Sabella. “Before Mondelez buys any ingredients or raw materials from any supplier, it conducts an audit of its facilities. Audits are then conducted periodically to ensure standards continue to be met.

“By 2018, every external manufacturer and supplier must be certified against a Global Food Safety Initiative (GFSI) scheme. Mondelez is making good progress towards that goal.”

GFSI drives market-leading guidance on food safety management systems throughout the supply chain. Its goal is continuous improvement. GFSI certification has covered packaging and materials manufacturers for many years.

In a report issued in late 2016 by the Association for Packaging and Processing Technologies, food safety guidelines issued by GFSI and other bodies – such as the British Retail Consortium and Safe Quality Food – are broadly in line with of FSMA.

Intertek’s Towara believes that standards will continue to rise, not least as the understanding of materials science continues to grow: “The legislative changes and updates that are happening through the EU commission, with scientific input from EFSA, represent an evolution in the approach of regulators, but EU harmonisation for all food contact materials is still lacking.

“While the rules are widely harmonised for plastics, most of the other food contact materials keep being regulated on the national level of EU member states. The rules for paper, for example, are not yet harmonised in Europe. Stakeholders are waiting for that to happen for the other food contact materials, such as paper. The next step is not to have a list of chemicals and migration limits only for plastics, but to use these already scientifically established safe levels for all materials, including paper, meaning to have just one list for all food contact materials, with migration limits reflecting the safety of substances, because substances are safe at a certain limit, no matter where their exposure is derived from.

“I am confident that this will happen. In addition, in regard to safety evaluation of chemical substances used in food contact material, the actual exposure will increasingly trigger the regulatory process of establishing limits, also taking into account sensitive groups, like babies or the elderly.”

Constant change

Maintaining food safety requires constant development of technical procedures and a nurturing of the skills necessary to understand the complex interactions that take place between food and packaging materials.

“The level of expertise of involved product safety people needs permanent upgrading,” notes Towara. “The effort to get new materials listed is nowadays more detailed, as science makes big improvements. We have more detailed toxicology and exposure models.

"With new materials, people know that they have to go through legislative procedures before they can go to market with food contact applications, but there will be innovations in the future. Besides others, there are new developments in plastics engineering, some of which are highly specified and have very sophisticated properties. There is also a lot of development in active or intelligent packaging, though this is not a strong market in Europe yet.”

There is no doubt that the science will keep evolving and standards will keep rising. The key is to ensure that every change is based on in-depth analysis and intensive testing, and that the market understands that the current regulations do ensure a high level of food safety. 



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