Interview: Public Consultation on Anvisa’s New GMP and HACCP Rules

Willian

Valesca, Anvisa opened Public Consultation No. 1,362/2025 with changes related to GMP and HACCP. In your view, is this really an important milestone or just another regulatory update?

Valesca

I see it as an important step in the maturity of Brazilian regulation. It is not a complete rupture, but it is a clear sign that the focus is moving away from simply “checking the box” and toward risk management, control effectiveness and real evidence that the system is working.

Willian

In practice, who do you think will feel the greatest impact?

Valesca

Mainly companies that still treat GMP and HACCP as documentary obligations. Those that already use these tools as part of business management tend to adapt with punctual adjustments. But organizations that still operate in a very reactive way will need to review processes, routines and even leadership posture.

Willian

You mentioned leadership posture. What is the role of top management in this new scenario?

Valesca

It is increasingly central. Food safety is not only a quality department topic. The proposal reinforces that investment decisions, resource prioritization and risk management are strategic issues. Without real leadership involvement, the system becomes bureaucracy, and that is no longer sustainable.

Willian

Many people say this proposal brings Brazil closer to international practices. Do you agree?

Valesca

Yes, I agree. We see clear convergence with Codex and schemes such as FSSC 22000 and others. For those already operating in this environment, none of this is unfamiliar. What changes is that national regulation begins to speak the same language in a more structured way.

Willian

And regarding HACCP itself, what do you think changes in how companies manage the plan?

Valesca

HACCP must stop being a document that sits in a drawer. It has to reflect the real process, with well-assessed hazards, validated controls and monitoring that truly drives decisions. The trend is greater demand for consistency between what is on paper and what happens on the plant floor.

Willian

There is also a strong discussion around food safety culture. Is this really new?

Valesca

It is not new. But now it becomes more explicit that culture is part of the system. It appears in how people react to deviations, in the quality of records, in whether the same problems repeat, and especially in leadership decisions. There is no value in having a well-written procedure if behavior does not follow it.

Willian

If a company asked you today where to start preparing, what would you recommend?

Valesca

I would start with an honest diagnosis: what in our system is real management, and what is only formality? Then I would look at three pillars: people, processes and evidence. If those three are aligned, the company not only meets the new rule, but also gains operational maturity.

Willian

To close, what message would you leave for the industry in light of this public consultation?

Valesca

I would say: do not look at this as a threat, but as an opportunity. Companies that use this moment to strengthen food safety management will become more competitive, more robust and better prepared for the future, not only for Anvisa, but for the market as a whole.