Preventive Controls for Human Food

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule  

Il Regolamento definitivo sui controlli preventivi degli alimenti destinati al consumo umano, (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule), è stato pubblicato come Final Rule (legge definitiva) sul Federal Register americano, (nostra Gazzetta Ufficiale), lo scorso Settembre 2015; è una norma della Food and Drug Administration (FDA), prevista dal Food Safety Modernization Act (FSMA), emanato negli USA nel Gennaio 2011.

Il Final Rule è entrato in vigore lo scorso Gennaio 2016 e dovrà essere implementato dalle aziende alimentari interessate a commercializzare prodotti destinati al consumo umano nel mercato statunitense, entro Settembre 2016.

Per le piccole imprese sarà concesso un ulteriore periodo di adeguamento di soli 6 mesi (Marzo 2017).

Il nuovo regolamento prevede, tra gli altri, l’obbligo da parte delle aziende alimentari di adeguarsi alla nuova documentazione richiesta comprendente:

• Hazard analysis and identification of preventive control;
• Supply chain management;
• Records maintenance and access;
• Intentionally introduced hazards;
• Traceability;
• Foreign supplier verification program;
• More frequent FDA inspections;
• Mandatory recall authority;
• Suspension of registration;
• Reinspection fees;
• Recall fees.

Il sistema di controlli preventivi, non va confuso con il sistema di autocontrollo attualmente implementato in EU ed Italia. Tale sistema infatti contrariamente alle innumerevoli interpretazioni regionali italiane, orientate alla semplificazione, crea una iper procedurizzazione aziendale molto simile a quella derivante dall’adozione di standard volontari di qualità (ISO 22000:2005).

Ogni azienda dovrà obbligatoriamente individuare un Preventive Controls Qualified Individual (PCQI), figura aziendale qualificata per la gestione delle procedure introdotte dalla norma. Questa figura potrà essere qualificata, frequentando un corso di 3 giorni tenuto da un Lead Instructor FSPCA Preventive Controls for Human Food.

FSMA Info

Current Good manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule.

The final rule regarding Preventive Controls on Human Food (Current Good manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) included in the Food Safety Modernization Act as published on the Federal Register on September 2015, is a regulation issued by the Food and Drug Administration (FDA) on January 2011.

The final rule has become law in January 2016 and the food companies involved in the commercialization of food product destined for human consumption on the United States must comply within September 2016.

In order to facilitate compliance, small companies will benefit from an additional extension of six months (March 2017).

The new regulation requires food companies to adjust to the new records system which includes:

• Hazard analysis and identification of preventive control;
• Supply chain management;
• Records maintenance and access;
• Intentionally introduced hazards;
• Traceability;
• Foreign supplier verification program;
• More frequent FDA inspections;
• Mandatory recall authority;
• Suspension of registration;
• Reinspection fees;
• Recall fees.

Preventive Controls system must not be confused with the current self-control system implemented in Europe. As a matter of fact, Preventive Controls systems creates a deeper proceduralization similar to voluntarily quality standards such as ISO 22000:2005).

It is mandatory for every food company to identify a Preventive Controls Qualified Individual (PCQI); a professional trained to handle all the procedures and practices required by the regulation. A PCQI will be qualified as such only after he attended a three-day long course delivered by an FSPCA Lead Instructor for Preventive Controls for Human Food.

FSMA Info