The audit came after an increase in notifications through the Rapid Alert System for Food and Feed (RASFF) of histamine above regulatory limits in, as well as outbreaks of scromboid food poisoning (histamine intoxication) associated, with tuna products originating in Spain.
The objective was to assess official controls in the Spanish tuna sector and actions by authorities after the notifications and following findings of the European Commission/competent authority joint mission from 26 June to 4 July 2017.
Spain, Italy, France, Croatia and Denmark reported illnesses last year as part of a histamine outbreak linked to tuna from suppliers in Spain and Mexico.
An EFSA assessment did not find a single event at a specific point in the supply chain that was the origin of all clusters of cases. However, it was likely that temperature abuse during post-harvest chilling, storage and/or processing played an important role.
Tuna sold as fresh
The EC/ES mission found brine frozen tuna (frozen between -9°C and -18°C) was being used to produce thawed tuna loins and marketed as “fresh” tuna – which is against regulation as such product must be for canning.
They also said colour change in the final product was ‘clearly visible’ which may influence the consumer.
The EC’s Directorate-General for Health and Food Safety audit team visited two cold stores, one site manufacturing frozen fishery products and three making thawed tuna loins with additives from 16 to 23 October 2017.
During the last three years, 51 notifications were issued (2015:10, 2016:12 and 2017:29 at end of September).
Further analysis showed products in the RASFF notifications were manufactured in 14 processing plants in six Autonomous Communities (ACs).
Joint mission conclusions
After the EC/ES joint mission preliminary findings were presented to competent authorities.
“Brine frozen tuna (frozen between -9°C and -18°C) was being used for the production of thawed tuna loins, subsequently marketed as “fresh” tuna. This does not comply with Regulation (EC) No 853/2004, which stipulates that such tuna must be destined for canning.
“The colour change in the final product was clearly visible, and may induce the consumer to perceive this product as (having characteristics similar to) a fresh product. FBOs are well aware, and have been warned on several occasions by the Commission services, that the induction of a colour change with this intention contravenes EU rules.”
Unauthorised and authorised additives
They found industry was not using unauthorised additives to promote colour change and did not identify widespread illicit activity, although illegal use of vegetable extract (containing nitrites) was identified in one production facility.
Spanish authorities suspended that production line and notified the RASFF system.
The EC/ES mission also established authorised additives appeared to be used in quantities up to ten times levels indicated in an EFSA opinion re-evaluating certain additives.
Spanish authorities traced the origin of products back to the fishing/freezer vessel. In most cases they did not identify any wrongdoing by the FBOs.
The authorities assessed records of temperature checks (raw materials, final products and transport) and analytical tests (raw materials, final products, chemical substances used and liquid injected) carried out in the framework of FBOs own checks.
MAPAMA is responsible for primary production of fishery products. MSSSI for all successive stages of production through AECOSAN and through SGSE, which handles controls on imported products.
A 2016 report showed authorities of ACs performed almost 20,000 controls in fishery products establishments.
They detected deficiencies in 17% of performed controls, divided between operational hygiene (6.4%), general hygienic conditions of structures (4%) and traceability (2.8%).
DG for Health and Food Safety audit
The DG for Health and Food Safety audit found Spain took measures to address points from the joint mission relating to eligibility of raw materials, colour change and associated use of additives but adequate use of authorised additives remained a concern.
In one establishment visited by the audit team the HACCP based procedures, which were under review, had minor deficiencies and at another site frozen fishery products showed signs of temperature abuse.
The audit found Spain could not demonstrate all establishments have been subject to controls to verify correct implementation of HACCP based procedures.
One AC suggested regulation that limits the use of tuna frozen in brine between -9°C and -18°C to canning, subsequently cooled down to -18°C, would meet requirements applicable to fresh-frozen tuna and did not indicate a willingness to conform to and enforce this EU requirement.
“There are still concerns with regard to one AC and its lack of adequate response to address the issues related with the correct use of additives at quantum satis principle and the regulatory eligibility of the raw materials used for the manufacture of thawed tuna loins treated with additives,” said the audit team.
Changes in one processing establishment meant production quantity dropped by 80% and prices of raw materials and final products increased.
Spain recommends use of authorized additives at levels that should not mislead the consumer or be used to mask defects of raw materials or incorrect production practices.
A change in the way additives are used resulted in products with a shelf-life two days shorter than before.
The level of 300 ppm indicated in the EFSA opinion is being used as reference for the levels of sodium ascorbate (E 301) and sodium citrates (E 331) in final products.
Authorities implementing checks based on colour change said the lack of any colour standard make actions difficult from a technical and legal perspective.
Spanish authorities said they would review control systems of tuna plants to ensure frequency, review HACCP procedures in processing establishments for fishery products, train inspectors ensuring official controls and hold a meeting with the sector to promote a guide to good hygiene practices.