Guidelines for Reworking, Revalidating, and Reprocessing Chemical Products

The Ministry of Agriculture, Livestock, and Supply (MAPA) has recently set forth new directives under Ordinance SDA/Mapa No. 1136, to enchance the reworking, revalidation, and reprocessing of chemical products within the agricultural sector. The guidelines encompass procedures and standards that must be adhered to by manufacturers, ensuring that reworked products meet the same quality standards as newly produced ones.

Key Aspects of the New Guidelines

Reworking Chemical Products

Reworking involves modifying or adjusting products that do not meet specified criteria. This includes changing primary or secondary packaging and updating or replacing labels and leaflets without extending the original expiration date.

Formulated products, premixes, and technical products within their expiration date may be reworked if they have:

  • Damaged packaging, provided there has been no leakage or contact with the external environment.
  • Compromising information about the batch, production date, or expiration date on the packaging.
  • Damaged labels or leaflets or contain incorrect information.

Revalidation Procedures:

Revalidation is the process of extending the original expiration date of products with an impending or expired date, ensuring they still meet safety and efficacy standards.

Technical products with an expiration date or expired for a maximum of one year, which preserve the registration specifications, may be revalidated. Formulated products and premixes can be revalidated for up to two years, provided they adhere to criteria for preserving the registration specifications.

Reprocessing Standards:

Reprocessing refers to converting non-conforming products back into a usable state. This includes mixing batches that are due or expired or making physical-chemical corrections.

Ensures that reprocessed products maintain high quality and safety standards.

Traceability Requirements:

Ordinance SDA/Mapa No. 1.136 defines traceability as the set of procedures that allow verification of all stages of rework, revalidation, or reprocessing of products. This involves using registered information and documentary elements to ensure transparency and accountability.

    Importance of the Guidelines

    Ensuring Product Quality

    • Enforcing stringent reworking, revalidation, and reprocessing standards ensures all chemical products in the market are of high quality.
    • Maintains the integrity of agricultural practices and protects consumer health.

    Regulatory Compliance

    • Helps manufacturers comply with national and international regulations, reducing legal risks and enhancing market access.
    • Ensures Brazilian agricultural products remain competitive globally.

    Environmental and Economic Benefits

    • Reduces waste by promoting proper reworking and reprocessing, contributing to environmental sustainability.
    • Allows manufacturers to recover costs by reprocessing non-conforming products instead of discarding them, promoting economic efficiency.

      Prohibitions and Compliance

      The ordinance prohibits the use of rework and revalidation procedures in cases of fraud or unauthorized modification of products. The import of expired products or those outside the registration specifications for the purposes set out in the ordinance is prohibited. Offenders will be subject to applicable responsibilities and penalties.

        Implementation and Enforcement

        MAPA will oversee the implementation of these guidelines through regular inspections and audits. Manufacturers are required to maintain detailed records of their reworking, revalidation, and reprocessing activities. Non-compliance may result in penalties, including fines and suspension of operations.

        Conclusion

        The new guidelines established by the Brazilian Ministry of Agriculture for reworking, revalidating, and reprocessing chemical products represent a significant step towards ensuring the quality and safety of agricultural inputs. By adhering to these standards, manufacturers can improve their operational efficiency, comply with regulations, and contribute to sustainable agricultural practices.

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