Compliance of Arts with ANVISA Regulations: Why Regulatory Review Is Essential

Compliance of Arts with ANVISA Regulations: Why Regulatory Review Is Essential

Packaging may look perfect, with a well-defined brand identity, the right colors, and all the information approved internally. Even so, a small detail in the artwork can pose a major risk if it does not comply with the requirements of the ANVISA.

For companies in the food, beverage, dietary supplement, cosmetics, personal care, and pharmaceutical sectors, the Regulatory Compliance for Packaging Materials It is a crucial step before printing and releasing the product to the market.

Missing mandatory information, a warning presented incorrectly, or even text that could mislead consumers can result in rework, product recalls, and significant damage to the brand.

Therefore, regulatory review should not take place only at the end of the process. It needs to be part of the process of designing and approving packaging.

What is regulatory compliance for the arts?

Regulatory compliance for a product involves verifying that all the information on the packaging meets the requirements applicable to that product category.

Depending on the type of product, there may be different rules regarding:

• required information;
• product name;
• list of ingredients;
• allergen declaration;
• nutritional information;
• mandatory warnings;
• conservation conditions;
• identification of origin;
• lot number and expiration date;
• directions for use;
• restrictions on use;
• the size and placement of certain information;
• commercial and nutritional claims;
• information that is not likely to mislead consumers.

The challenge is that these requirements vary depending on the product category and may be changed or supplemented over time.

Therefore, simply reusing a previous package as a reference does not always guarantee that the new design will be compliant.

Why is compliance with ANVISA so important?

When packaging reaches the consumer, it becomes one of the main sources of information about the product.

It is through this label that consumers can identify ingredients, composition, characteristics, restrictions, instructions for use, and other information important to their purchasing decision.

For this reason, labeling regulations exist not only to standardize information but also to protect consumers.

For the industry, keeping artwork compliant reduces various types of risk.

Reduction in rework

Finding an error before printing is much less expensive than identifying it after thousands of packages have already been produced.

An inconsistency detected only in the final phase may require:

• artwork modification;
• new approval;
• creation of new files;
• new engraving of printing plates or matrices;
• reprint;
• packaging disposal;
• delay in the product launch.

The sooner the problem is identified, the less severe its impact tends to be.

What happens when non-compliant packaging is already on the market?

This is one of the scenarios that concerns companies the most.

When packaging with a regulatory issue is already on the shelf, the problem is no longer limited to the creative or prepress department.

Depending on the situation and the severity of the noncompliance, consequences may include the need to correct labeling, product recalls, notifications to the relevant authorities, logistics costs, and commercial impact.

There is also one factor that cannot be ignored: consumer confidence.

Incorrect or incomplete information on packaging can raise questions about the product itself and about the quality control practices of the company responsible for it.

Building trust takes years.

You could lose it in just a few minutes.

The complexity of manually inspecting a package

Most companies still conduct regulatory reviews using spreadsheets, internal documents, checklists, and the expertise accumulated by the professionals responsible for approval.

This process is important, but it has its limitations.

A single package may contain dozens or even hundreds of pieces of information. In addition, different versions of the same artwork may circulate simultaneously among marketing, quality assurance, regulatory, the agency, prepress, and suppliers.

In this scenario, certain problems become more likely:

• use of an outdated version of the artwork;
• omission of required information;
• application of a rule pertaining to another product category;
• inconsistency between versions;
• approval without the involvement of the regulatory department;
• a different interpretation of a requirement;
• changes to the text after approval;
• the use of outdated regulations.

This is exactly where technology can help.

Automating the Verification of Regulatory Requirements

Specialized art approval tools can add an automated layer of control to the process.

In the eyeView, for example, a compliance review can examine the artwork based on the product category and identify potential inconsistencies related to the regulatory requirements configured in the system.

The goal is not to replace the assessment made by the professionals responsible for the regulatory area.

The technology serves as an additional layer of security.

It helps answer an important question before approval:

Is there any information in the artwork that needs to be reviewed before we send this package to production?

By automating part of this verification process, the company is able to reduce repetitive tasks and direct its professionals' attention to situations that truly require analysis.

Compliance should be part of the approval process

One of the greatest benefits occurs when the regulatory conference is no longer treated as an isolated step.

In a structured workflow, a new version of the packaging may undergo various checks before final approval:

1. creation or modification of artwork;
2. submit for review;
3. comparison with the previous version;
4. verification of texts and information;
5. analysis of regulatory requirements;
6. prepress technical review;
7. approval by the relevant departments;
8. release for production.

In this way, compliance becomes an integral part of the approval process itself.

This ensures traceability and reduces reliance on checks performed only at the end of the project.

The Role of Artificial Intelligence in Packaging Compliance

With advances in artificial intelligence, approval systems are beginning to interpret more and more of the information found on packaging.

In addition to searching for text, a platform can match the content it finds with previously registered requirements and identify areas that need attention.

Imagine a product’s artwork being analyzed automatically, with the system checking, among other things:

What information should be included on this package?

Were the required warnings found?

Are there any texts that need to be revised?

Are there any significant differences from the previously approved version?

This type of automation transforms the review process.

Instead of relying solely on a lengthy manual review, the professional also begins to address the exceptions and alerts identified by the system.

Compliance is not just a regulatory requirement

Many companies still view compliance merely as a necessary obligation to comply with the law.

In practice, it also translates to operational efficiency.

A more reliable approval process means less rework, less waste, greater traceability, and a lower chance that incorrect packaging will reach production.

Compliance also protects one of the most important assets of any company:

the brand's credibility.

When a consumer buys a product, they expect all the information on the packaging to be clear and reliable.

Ensuring this should be the responsibility of the entire supply chain involved in the creation of the packaging.

How eyeView Helps with Artwork Approval and Compliance

O eyeView It was developed to centralize and make the artwork review and approval process more secure.

The platform allows you to bring together different stages of the process in a single environment, including features for:

• online art review;
• version control;
• file comparison;
• comments and notes;
• approval history;
• change tracking;
• technical inspections;
• analysis of regulatory requirements;
• integration with external workflows and systems.

By automating the review process, teams can identify potential issues during the approval process, before the artwork is released to production.

Conclusion

An irregularity in packaging can start with a small detail in the artwork.

But after printing, this detail can lead to rework, waste, delays, regulatory risks, and a loss of trust.

For this reason, companies that handle large volumes of packaging on a daily basis need to transition from processes based exclusively on manual checks to more structured and automated approval workflows.

Technology does not eliminate the importance of regulatory experts.

It expands its control capabilities.

With tools from packaging compliance, through art review and automation, it is possible to identify risks earlier and make the entire approval process more secure.

Would you like to learn how eyeView can help your company automate the review and approval of artwork and add compliance checks to the process?

Learn more about eyeView at eyeview.pro.