Food Law News - EU - 2005

FSA Consultation, 9 September 2005

HYGIENE - Draft EU Regulation for Microbiological Criteria for Foodstuffs 2005

The Agency is seeking comments on the draft EU Microbiological Criteria for Foodstuffs Regulation 2005 and the associated partial UK Regulatory Impact Assessment (RIA). Responses are requested by: 3 November 2005

[Note: the documents are available on this site at: Draft EU Regulation for Microbiological Criteria for Foodstuffs 2005 and Partial Regulatory Impact Assessment]

Consultation details

The key provisions are:


The draft Commission Regulation on the Microbiological Criteria for Foodstuffs 2005 will apply from 1 January 2006 and complements the Food Hygiene Legislation (EC) No 852/2004.

The regulation replaces various existing commodity-based EU legislation containing microbiological criteria. These will be revoked on 31 December 2005 . In the main, these criteria have been for products of animal origin such as eggs, shellfish, fish, meat and their products. Where criteria have not been set, some Member States have established their own national criteria.

At present, a variety of non-uniform microbiological criteria are being used and this has led to problems for imports and UK businesses where the same product must comply with different standards. As part of the consolidation of EU food hygiene legislation, it was recommended that the microbiological criteria should be harmonised, relevant and effective in relation to consumer health protection, based on risk assessment, and consider the latest available scientific evidence.

The regulation will apply to all food businesses involved in the production and handling of food, i.e. primary producers, manufacturers, processors, distributors, retailers and caterers are all affected. As a general rule, there is no requirement for increased end product testing or for positive release. Flexibility exists with regard to the actions that can be taken to ensure compliance with the criteria.

Food businesses in the main can set sampling and testing plans, as part of a risk-based food safety management plan, that are proportionate to the nature and size of the business. Equally, it allows food business operators to use the criteria within their own controls, and allows alternative indicators to be monitored to ensure the criteria are being met.

The Competent Authority is required to verify that the food business operator complies with the Regulation and use microbiological criteria for official control purposes in line with requirements in the Official Feed and Food Control Regulation ((EC) No 882/2004). The Commission is working with Member States to develop guidelines for the use of microbiological criteria for official control purposes.

The negotiations are complete and the regulation has been accepted following a qualified majority vote at the Standing Committee (SCoFCAH) on 22 June 2005 . The regulation will be formally adopted in September or October. The Agency has begun the formal process of implementing the proposed regulation. The Statutory Instrument being prepared to give effect to the EU Food Hygiene Legislation will also include the necessary provisions to give effect to the Microbiological Criteria Regulation.

An FSA consultation will be issued on the draft SI. Also, we plan to issue a separate consultation on the supporting guidance at a later date, although the consultation on this is expected to run for less than 12 weeks in order that advice can be in place for 1 January 2006 .

Partial Regulatory Impact Assessment

The Agency is seeking views and further information as part of this consultation to inform the partial RIA to determine the full impact of the regulation on UK businesses. Responses are required by 3 November 2005 .

Information Requested

Proposed Regulation for Microbiological Criteria for Foodstuffs: The negotiations are complete and there are unlikely to be any further amendments to the proposed regulation before it is adopted during September or October 2005. Therefore the Agency is seeking views and comments on the proposed regulation where food businesses and enforcement authorities may require further clarification with the interpretation. Your views will inform the supporting guidance on which we will be consulting later this year.

Partial Regulatory Impact Assessment

Consultees are asked to provide information on estimated costs associated with implementing and enforcing the regulation during the first year of operation and any additional costs thereafter that fall upon:

The Agency has undertaken an initial assessment of the potential benefits and impact of the proposed Regulation in the UK . We are seeking (i) views on whether these are an accurate reflection; and (ii) an indication of what businesses are currently doing so that we are able to assess any extra burden introduced by the regulation.

The proposed Microbiological Criteria Regulation is not expected to have any consequences for sustainable development or any environmental implications. However, if this is not the case, food business operators are asked to provide views or information on the effect and evidence of increased costs.

It has been suggested, during a past stocktaking exercise that there would be extra costs to enforcement authorities, who will need to spend time explaining the new requirements to proprietors and clarifying how they are to be applied, particularly if guidance is not clear and easy to understand. Do you have any views or information to contribute on any additional burdens on enforcement officers, e.g. whether increased implementation and/or enforcement costs and additional sampling may be introduced by the regulation? Are you able to estimate the time and therefore cost required for an enforcement officer to explain the new requirements to a food business?

The Agency is seeking further information as part of this exercise to determine:

The proposed regulation allows some flexibility to derogate from the proposed sampling frequency. Article 4 says that the frequency of sampling may be adapted to the nature and size of the food business, provided that food safety is not endangered. In addition, Annex I, Chapter 3.2, allows small slaughterhouses and establishments producing minced meat and meat preparations to be exempt from the sampling frequencies. We are therefore seeking your views on whether and to what extent the UK should make use of these flexibilities. Your views will inform the supporting guidance on which we will be consulting later.

Consultees are asked to provide any accurate information that may assist with the calculation of the costs of the actions required associated with an unsatisfactory batch of minced meat or meat preparations intended to be eaten cooked.

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