EU DG Health and Food Safety audit in Sweden – Unexpected flaws in microbial safety of food of non-animal origin

Here below the summary of a recent audit of the EU Commission services on the Swedish official control system for food of non animal origin (in particular frozen food and sprouts/seeds for sprouting). Beside the detected shortcomings, is quite unusual to notice that from internal audits from 2014 and from EU Commission audit in 2015, nothing or little improvements have been made.

“This report describes the outcome of a DG Health and Food Safety audit in Sweden which took place from 18 September to 27 September 2018 under the provisions of Regulation (EC) No 882/2004 of the European Parliament and the Council of 29 April 2004.

The objectives of the audit were to assess:

 the system of official controls in the area of food hygiene to prevent microbiological contamination in the production of food of non-animal origin, notably as frozen products and sprouts and seeds intended for sprouting;

 the extent to which the corrective actions submitted to the Commission services in response to the recommendations of the previous Directorate-General for Health and Food Safety audit report of 2015 have been implemented and their effectiveness in addressing the identified shortcomings.

Overall, a risk-based control system for official controls on food of non-animal origin is in place. There is a system for registering primary producers and for the approval of sprout-producing establishments. This facilitates the implementation of a risk-based approach to official controls including microbial risks associated with food of non-animal origin.

Regarding official samples, the appropriate laboratory capability and capacity is available.

Significant shortcomings were identified in relation to the registration of food business operators and approval of sprout-producing establishments. The approval system does not ensure that noncompliances have been rectified before that approval is granted. In addition, the official control system presents a number of gaps, notably related to provision of specific instructions, technical support and staff training. As a result, official controls cannot be implemented correctly and effectively, resulting in poor controls. This impacts on the enforcement, where non-compliances are hardly detected and when detected are rarely followed-up.

A number of these shortcomings were equally reflected in the outcome of an internal audit performed by the Central Competent Authority
in June 2018, and which found little corrective action since the previous internal audit, in 2014.

Thus, non-compliant products might be undetected and the correct application of the relevant legislation might not be enforced, resulting in placing on the market of non-compliant products which may present a health risk.

In respect of the follow-up to the previous audit, certain actions have not been effective in addressing the identified shortcomings. Overall, the audit had to conclude that there has been limited improvement compared to what was found previously.”

(Source: DG Sante website)

China – FVO report on microbiological contamination in seeds for human consumption

The audit was carried out from 14th to 18th October 2013 to evaluate the official controls related to production and processing of seeds for sprouting intended for export to the European Union, becaus of the recent oubreaks of Shigatoxin producing E. coli (STEC) in EU and the large Chinese production.

The main Regulations applicable in EU for these products are:

– Reg. CE n. 178/2002 “General Food Law”;

– Reg. CE n. 852/2004 on hygiene requirements for food of non-animal origin;

– Reg. EU 211/2013 on the approval of establishments producing sprouts and the certification for imports into the EU of seeds for the production of sprout.

The objectives of the audit were only partially met, as the audit team was unable to visit primary producers of seeds for sprouting.

The Chinese Competent Authorities (CAs) have started to implement some of the requirements of the EU legislation on sprouts and seeds for sprouting, however there was no evidence provided regarding the hygienic conditions of seed production at farm level and there are no official controls for primary production of seeds for sprouting. The processing facilities visited by the audit team followed Good Hygiene Practices except in regard to the storage facilities. The effectiveness of the official control system is undermined by limited official sampling for microbiological contamination and the lack of representativeness of the official samples. The laboratories visited were accredited and suitable for the purpose of official microbiological analysis with the exception of Shigatoxin producing E. coli (STEC).

The system of official food safety controls currently in place cannot assure that the seeds for sprouting were produced under conditions which comply with the general hygiene provisions for primary production and associated operations set out in Part A of Annex I to Regulation (EC) No 852/2004 as required by Article 3 of Regulation (EU) 211/2013. This applies also for the 2013

The Chinese CAs acknowledged the fact that official food safety controls on farms do not take place and proposed a future follow-up audit by the FVO to observe implementation of the general food hygiene requirements at farm level.