Irish infant formula official controls system backed
Results found training was needed for interpreting sampling plans/results and equivalent testing methods and businesses should instantly inform authorities of issues that affect product safety regardless of regulation.
The Food Safety Authority of Ireland (FSAI) audited official controls performed by the Department of Agriculture, Food and the Marine (DAFM) Dairy Produce Inspectorate (DPI).
Objectives were to verify surveillance of infant formulae and follow-on formulae establishments.
The audit from December 2016 to April 2017 determined the level of compliance with Regulation (EC) No 882/2004 on official controls performed to ensure verification of following feed and food law, animal health and welfare rules.
The first part involved an audit of paperwork associated with official controls, including the establishment’s files and inspection reports.
The second part included audits of four manufacturers of infant formula and follow-on formula and one milk base powder ingredient plant.
Microbiological analysis
The audit team noted industry uses alternative analytical methods for microbiological analysis that are validated against reference methods in Annex I of Commission Regulation (EC) No 2073/2005.
Authorities, including the FSAI and the DAFM, should put a procedure in place to enable assessment of the equivalence of alternative methods used by industry.
Chemical and compositional sampling was done to verify compliance with Commission Directive 2006/141 on infant formulae and follow-on formulae and when product is exported to third markets, compositional criteria are applied.
In one establishment, in June 2016, microbiological non-compliances in the product and production environment were identified by the food business operator (FBO) and corrective actions were being implemented. No non-compliant product made it to the market.
An official control audit prior to the FSAI’s reviewed micro controls and the food safety management system of the FBO and microbiological non-compliances were not documented in the inspection report although the DAFM was following up the inspection with a review of the food safety management system.
Further information was requested by the DAFM Inspectorate in January 2017 on microbiological issues in the plant. Following an investigation in the same month, a compliance notice was issued by the DAFM; further corrective actions were requested by the audit team and these have been addressed by the FBO under supervision of the DAFM.
Considering the product and vulnerable consumer population, the audit team recommended the DAFM systems of official controls should be reviewed to request the FBO to inform the agency immediately of issues which may affect safety of products, even where there is no explicit statutory requirement to do so.
“The DAFM will develop and implement procedures to request the food business operator to inform the DAFM immediately of any issues which may affect the safety of the products manufactured,” said DAFM in a corrective action plan.
Training requested
The audit team noted detailed food safety management systems based on HACCP principles (including procedures and records) at each establishment to comply with food safety regulatory requirements.
In one establishment, some issues around cleaning and maintenance of equipment had been identified by the FBO prior to the audit and were being addressed under supervision of the DAFM.
Non-compliances identified during DAFM inspections are recorded on a corrective action report and followed up by the Assistant Agricultural Inspector (AAI).
Specific training is required in relation to interrogation of sampling plans/results and interpretation of equivalent testing methods by industry to determine compliance with Commission Regulation (EC) No 2073/2005 and the preventative maintenance and engineering programmes at these facilities.
“The establishments audited are large, complex food businesses with elaborate systems of controls that require specialist knowledge to interrogate and monitor,” said the audit report.
“Therefore, further specialist training should be provided to inspectors, and a review of documented procedures to address the findings of this audit is recommended in order to maintain the adequacy and effectiveness of controls.”
