Science and legislation in the trajectory of
proof of safety of new ingredients
Today's topic is of great interest to the food industry. We'll discuss science and legislation in the safety of new ingredients.
And, to help us better understand this scenario, we invited Aline Cavalcante, Senior Scientific Support Analyst at Ayalla, to talk about this topic.
Check out this content we have prepared for you!
Safety assessment of new ingredients
When it comes to the safety assessment of new ingredients, in terms of ANVISA, we are automatically directed to Petition 4109. According to Aline, it deals with the safety and efficacy assessment of functional or health properties of new foods and new ingredients, except probiotics and enzymes.
Considering ANVISA's objectives in this safety assessment, it is a matter of adequately characterizing the ingredient or what is in its composition, taking into account its key parameters, analytical parameters and whether or not it poses any safety risk.
Furthermore, it is verified whether the manufacturing process does not induce or concentrate any substance that poses a health risk and, finally, to verify whether the recommended consumption does not exceed levels considered safe.
And how is this petition made then?
This occurs through a complete dossier of scientific evidence that must be sent to ANVISA.
To analyze this material, the agency follows 1999 legislation that regulates new foods and new ingredients, which is currently being reviewed by the regulatory agenda.
Another material used by ANVISA for this assessment is a 2019 guide to verifying the safety of food and ingredients. It provides a step-by-step guide on how this dossier should be created.
This guide is divided into four parts, covering hazard identification, hazard characterization, exposure assessment, and risk characterization.
In general terms, this is exactly what ANVISA expects to receive from those who wish to submit this petition.
History of authorized constituents in dietary supplements
According to Ayalla's Senior Scientific Support Analyst, it is now common knowledge that the regulatory framework for dietary supplements was published in 2018.
In this context, Normative Instruction 28 was published, which contains a positive list of all constituents that are authorized for use in dietary supplements.
This means that, in general, everything on this list can be used in the development of a new product.
In 2018, when this Normative Instruction (IN) was drafted, it covered approximately 380 constituents. The first update to this material came only in 2020, with IN 76. At that time, 43 new constituents were included.
Then, the second update came, and 51 constituents were added. Currently, 41 ingredients are waiting to be added to the next list.
However, Aline emphasizes that, once an ingredient is published in the official journal, this process already serves as proof that it is approved and authorized. In other words, it simply isn't on the unified list of authorized constituents.
Simplified petitions
To conclude this reading, the expert provided context on simplified petitions. Aline pointed out that they are an ANVISA strategy to reduce waiting times in the analysis queues for a new ingredient.
To give you an idea, the queue currently has 69 cases and the average waiting time between entering the queue to file a petition and making the first request is around two years.
Simplified petitions are essentially four categories of petitions in a single waiting list. "Generally, ANVISA's waiting lists cover only one or two topics, and simplified petitions are different," explains the professional.
In this path of simplified petitions, the big difference is that the dossier does not require proof of security, which is already a major advance in terms of saving time for the sector.
However, documentation relating to ingredient identification remains mandatory and, currently, the simplified petition queue has 14 processes awaiting the analysis stage.
It is worth noting that simplified petitions are applicable when the specification of the object of analysis has already been approved, that is, that ingredient has already passed all of ANVISA's evaluation stages.
However, there are situations where the applicant for an already approved ingredient is changed or even when an applicant is going to expand the specification of an approved ingredient.
Reflections worth checking out
To conclude this content, Aline highlighted some points that will be essential if you want to file a petition with ANVISA:
Pay attention to managing the dossier documents to ensure they are sufficient. The review process takes a long time, and a negative result can disrupt your future plans.
Also, remember that ANVISA's deadline is different from yours. Petitions take time, and the wait is long.
Finally, before submitting your dossier, conduct a complete feasibility study of your ingredient.
ANVISA provides a series of tools in terms of legislation, such as frequently asked questions and a contact us form.
“Use all these tools to have sufficient scientific and regulatory support to achieve a robust process,” concludes the expert.
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