Brussels, 16 April 2004

Mr Eric POUDELET
European Commission
DG SanCo
Head of Unit, D2
B- 1049 Brussels.

Dear Mr Poudelet,

In response to your letter of 10 March 2004, please find below EURO COOP comments on the new draft Commission Regulation on microbiological criteria for foodstuffs.

As stated in our comments last year , EURO COOP welcomes the Commission initiative to revise existing microbiological criteria which must be applied by food business operators in the framework of their HACCP procedures. Existing criteria have not been revised since they were first set, although they were not established on the basis of a formal risk assessment1 . EURO COOP considers this proposal to be an important complement to the Commission proposals on hygiene currently discussed at the European Parliament and Council and to the new EU legislation on zoonoses2 .

Food borne pathogens, in particular Salmonella, Campylobacter, Listeria monocytogenes, verotoxigenic E. Coli and Bacillus cereus, are a public health problem requiring action from public authorities both at European and national level. As recalled by the World Health Organisation, 130 million Europeans are affected by episodes of food borne diseases3 . We therefore agree with the importance of Community microbiological criteria to be used as reference points, especially in the validation and verification of the correct functioning of HACCP based procedures.

EURO COOP believes this new draft to be improved compared to earlier drafts. In particular, it seems to have moved back into line with the Commission Strategy of December 2002. However, consumer co-operatives believe it could be strengthened. The following comments highlight the key main issues we would urge you to take on board in the current discussions within your service and with the Member States:

• Implementation of the "farm to fork" principle

As mentioned in our comments last year, EURO COOP welcomes the stable-to-table approach of the Commission enshrined in the new EU Food law legislation. Euro Coop has always argued for an integrated approach, which it has reiterated in its comments on the Commission's proposal on the general principles of food law and establishing the European Food Authority. Recent food scares have proved that contaminated animal feeds have been an indirect cause of food hazards and need to be strictly controlled to prevent future problems occurring.

However, Euro Coop is concerned that the draft Regulation on microbiological criteria for foodstuffs and food production may impede the full implementation of the farm to fork principle. This draft proposal indeed refers to the Commission's proposal on the hygiene of foodstuffs, which exempts farmers from the HACCP system. Euro Coop reiterates its opposition to this exemption and urges the Commission to take appropriate measures to implement the farm to table principle. Exempting farmers is in contradiction with the "farm to table" principle.

We would like to recall one of the recommendations of the Scientific Committee on Veterinary Measures relating to Public Health, which states in its Opinion of April 2000 that "the prevalence reduction strategies at farm level for Salmonella sp., Campylobacter sp. and VTEC O157 should be further investigated"4.

In EURO COOP's view, a comprehensive policy on the control of food-borne diseases should also address the issue of agricultural practices. Many of the recent food scares have been linked to standards on the farm and primary production level (BSE, dioxin, sewage sludge, etc.) and have resulted in the loss of consumer confidence and resultant decrease in consumption of the products concerned. EURO COOP therefore believes that it is in the common interest of farmers, consumers and all parties involved in the food chain to ensure the implementation of, and compliance with, high safety standards throughout the food chain. This will also contribute to ensuring the competitiveness of the European farming model at international level, which must remain associated with high quality standards and production methods.

• Scope of the proposal

Most EURO COOP members regret that Campylobacter is not addressed in the revised draft proposal. Converging scientific evidence shows that this zoonotic agent is one of the public health priorities in Europe. In April 2000, the Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) concluded that "the most important food-borne zoonoses currently are Salmonella and Campylobacter"5 . The Commission strategy of December 2002 itself classifies Campylobacter under the food-borne pathogens of "most concern" and states that "although it is infrequently associated with outbreaks, it is nevertheless an important agent in sporadic cases of food-borne diseases"6 .

Given the impact of Campylobacter on public health, most EURO COOP members regret that the European Commission has requested an Opinion on Campylobacter in animals and foodstuffs from the European Food Safety Authority Panel on Biological Hazards only in September 2003. EURO COOP would welcome a consultation with stakeholders on the risk management measures that might be taken on the basis of the Panel Opinion scheduled for end-2004/early-2005 to complete the draft proposal on microbiological criteria.

• Analyses of trend

EURO COOP notes with satisfaction that a new Article on the analyses of trends has been introduced in the new draft (Article 7). As stated in the Commission Strategy of December 2002, in addition to comparing the results against the criteria, it is preferable that food businesses also follow and assess the trends in the results over a long period of time".

EURO COOP would however like to see further details on the implementation of this measure. EURO COOP agrees that the recourse to a Regulation would ensure a faster implementation of the microbiological criteria. However, EURO COOP wishes to stress the need for the Regulation to be precise and clear in its drafting, as it will be prescriptive and mandatory.

• Specific comments on the Annex I


• EURO COOP believes that splitting of the Annex into separate parts covering food safety criteria and manufacturing criteria works better than the previous format. However, we do have concerns regarding the title of part 1 and would suggest that a better title would be 'Some Microbiological criteria relevant to the safety of certain foodstuffs' as the current title implies that if the food conforms to the criteria set-out in that part of the Annex it is microbiologically safe, when this may not be the case because of the presence of other micro-organisms. There is also the question of whether a food is unsafe because it contains low levels of some micro-organisms which may or may not be pathogenic according to strain; indeed it is questionable without setting sampling frequencies at what would be a commercially unacceptable level whether any batch could be determined as being 'safe'.
• EURO COOP agrees with the proposed limits for Salmonella (Annex I pages 13 and 14). However consumer cooperatives believe that it would be more appropriate to have the criteria in one box for all foods (absence in 25 g - with N=5 and c=0).
• The criteria for Listeria monocytogenes should cover all kind of products, not only ready-to-eat foods. We are disappointed to see that some products, e.g. bread and biscuits and similar products, sugar, honey and sweets, fresh, uncut and unprocessed vegetables and fruits - excluding sprouted seeds- are excluded from the scope of the proposed Regulation7. We believe that none of these foodstuffs should be sold if they contain more than 100 cfu/g.
• Most EURO COOP members call for the establishment of criteria for Campylobacter, S. aureus and B. cereus. EURO COOP would also urge the Commission to complete the missing data for vegetables, fruits and products thereof.
• EURO COOP finds the term "fresh fermented sausages" (Annex I, page 13) unclear as the terms "fermented" and "fresh" are contradictory words. For example, in Italy, the fresh sausage called "salsiccia" is marketed within 24 hours from production and must be free of salmonella in 125 grams.
• EURO COOP considers that the value for histamine (Annex I, page 16) seems excessive given i) the histamine content in fish captured, transported, and stored under GMP (between 20 and 50 ppm), and ii) the existence of highly sensitive people which may undergo clinical symptoms at above 200 ppm.
• Some EURO COOP member organizations wish to stress that consumers may suffer from staphylococci enteroxicosis even at very low amount of toxins in food, e.g. the amount produced by around 5 log of toxigenic staphylococci. In our view, the M limit of 5 log does not offer enough protection to consumers (Annex I, page 27) as there is a lack of a minimal safety area before the level associated to possible toxin accumulation.

We hope these comments will prove useful for you and your services and that they will be taken into account in the revised draft Regulation.

Yours sincerely,

Aude L'hirondel
Food Policy Officer

Cc: Ms J. Husu-Kallio, Deputy Director-General, DG SanCo
   Ms P. Testori-Coggi, Director, Directorate D, DG SanCo
   Mr J.C. Cavitte, Administrator, D2, DG SanCo