Draft Food Hygiene (England) (No 2) Regulations 2005

The key proposals

• to change definitions and Schedules which would extend the application of the domestic Regulations to include various Commission implementing and transitional measures
• to create an offence for failure to comply with Commission legislation on microbiological criteria
• to create an offence for failure to comply with certain aspects of the Commission legislation on Trichinella in meat
• to change the regulation providing for the enforcement and execution of the EU Food Hygiene Regulations
• to extend the use of the remedial action notice and detention notice to all food businesses to which the Regulations apply

Please note that links to all of the documents referred to can be found at the foot of the page.

The Food Hygiene (England) Regulations 2005 apply the EU food hygiene regulations and were subject to public consultation from 11 October 2004 to 31 January 2005. The European Commission is proposing a number of regulations containing implementing and transitional provisions which affect the application of the EU food hygiene regulations. It is necessary to provide for the application of these in national legislation.

The proposed Commission regulations and copies of the latest versions of these proposals are available at the foot of this page. These have been subject to consultation. None of these has yet been formally adopted and published in the Official Journal; however, in order to be able to provide for their application from 1 January 2006, we are consulting now, on the basis of the latest drafts.

We are also taking the opportunity to make other amendments to the Food Hygiene (England) Regulations to reflect developments which have occurred since the first SI was made. The amendments are described below and comments on these are invited.

Amendments to apply the Commission implementing and transitional measures
For the most part, the only change necessary to apply the measures (which will be directly applicable Commission Regulations) is to include reference to them in the definitions which refer to the EU food hygiene regulations. Changes have therefore been made to the definitions of 'the Community Regulations' and to the list of Community legislation cited in Regulation 2(1) and to Schedule 1. Equivalent changes will also need to be made to the Official Feed and Food Controls (England) Regulations 2005.

In order to apply fully the proposed Commission Regulation on microbiological criteria (Annex H), it is necessary to create an offence where food business operators fail to take the actions set out in the Annex to that Regulation, as required by Article 7 of the proposal. This has been done by adding an appropriate entry in Schedule 2. An offence has also been created to apply Article 9 of the proposed Commission Regulation on Trichinella in meat (Annex L)

Other amendments
We are taking the opportunity to amend the definition of 'food authority' in Regulation 2(1). This will bring it into line with other legislation, but does not alter the scope of the definition. Consequential changes are that a definition of 'port health authority' has been included.

We are proposing a change to the responsibility for enforcing the EU food hygiene regulations at the level of primary production, as described in Regulation 5(1)(a). Currently, this responsibility lies with the Food Standards Agency alone. We are proposing that this responsibility may be exercised by either the Agency or by a food authority. This change reflects the fact that decisions have yet to be taken on who will be responsible for undertaking this enforcement responsibility. The formula proposed in Regulation 5(1)(a) is one used elsewhere in the Regulation and provides for responsibilities to be described more fully in, for example, the Code of Practice and Practice Guidance (in the case of food authorities) or in Service Level Agreements that the Agency may make with other enforcement bodies. As such, this change broadens the scope of which enforcement authority might undertake this work. Separately, work is ongoing to consider the form of enforcement of the hygiene legislation and which body should undertake this. We will continue to consult stakeholders on these developments.

The Commission has recently clarified that activities undertaken at egg packing stations are not primary production. Egg packing stations would therefore be subject to the general hygiene requirements of Annex II to Regulation 852/2004 and any specific requirements for shell eggs in Regulation 853/2004. It would also be necessary for them to comply with the requirement to have in place food safety management systems based on HACCP principles (Article 5 of Regulation 852/2004). Enforcing and executing these requirements would be more appropriately undertaken by food authorities than by (in the case of England) Defra's Egg Marketing Inspectorate. The precise extent of the enforcement responsibility and how it is to be carried out still needs to be determined. In order to allow this to be developed, it will be necessary to make the activities described in Regulation 5(2)(a)(iv) of SI 2005/2059 subject instead to Regulation 5(2)(b). This has been achieved in the draft SI by deleting Regulation 5(2)(a)(iv).

We are proposing to limit the role for the Agency in respect of premises described in Regulation 5(2)(a)(i) to (iii) of SI 2005/2059 to those premises which are approved, or conditionally approved, or licensed under current legislation. 'Non-approved' premises are to be subject to enforcement action by the food authority. This retains the current arrangements for enforcement in respect of certain meat plants. This has been achieved in Regulation 5(2)(a) and (6) of the draft SI.

We are proposing extending the use of remedial action notices and detention notices to all food businesses to which the legislation applies, including those at the level of primary production. They are currently only available in respect of premises subject to approval under Article 4(2) of Regulation 853/2004. This has been achieved by removing the limiting reference to approval under that Article in Regulation 9(1) and 9(5) of SI 2005/2059. Your comments on this course of action would be welcome.

We are proposing to amend Regulation 13 to provide that samples taken in accordance with the Regulations are subject to the Food Safety (Sampling and Qualifications) Regulations 1990 in the same way that samples taken under the Food Safety Act 1990 are.

The changes from SI 2005/2059 are set out in the table below for ease of reference.

This consultation has been prepared in accordance with the HM Government Code of Practice on Consultation, which states that a consultation must follow better regulation best practice, including carrying out an Impact Assessment (Regulatory Impact Assessment in Scotland). The assessment is included in the consultation documents.

We are interested in what you thought of this consultation and would therefore welcome your general feedback on both the consultation package and overall consultation process. If you would like to assist us to improve the quality of future consultations, please feel free to share your thoughts with us by using the consultation feedback questionnaire.

Consultation feedback questionnaire (Word)

Consultation feedback questionnaire (pdf)

In accordance with the FSA principle of openness our Information Centre at Aviation House will hold a copy of the completed consultation. The FSA will publish a summary of responses, which may include personal data, such as your full name. Disclosure of any other personal data would be made only upon request for the full consultation responses. If you do not want this information to be released, please complete and return the Publication of Personal Data Form. Return of this form does not mean that we will treat your response to the consultation as confidential, just your personal data.

Data protection form (Word)

Data protection form (pdf)

Within three months of a consultation ending we aim to publish a summary of responses received and provide a link to it from this page.

If, after three months, the summary is still not showing, please contact the person who was responsible for the original consultation. Alternatively, you can contact the FSA Consultation Co-ordinator by email: consultationcoordinator@foodstandards.gsi.gov.uk