The Feed (Specified Undesirable Substances) (England) Regulations 2009

Introduction

At present, there are no tolerances for the potential carry-over of technically unavoidable residues of coccidiostats in feed intended for one species of farmed livestock into feed for another. This can be a particular problem for feed business operators who are producing a range of feedingstuffs within one establishment, where a number of different feed products may be manufactured on the same production line. Commission Directive 2009/8/EC of 10 February 2009 sets maximum permitted levels for these residues, to provide harmonised Community rules in this area without posing increased risks to animal and human health. The measure requires transposition into law in England.

Proposals

The Directive's key features are:

• The maximum permitted levels for the potential carry-over of coccidiostats into feed are laid down by amendment to the Annex to Directive 2002/32 on undesirable substances in feed.
• These maximum permitted levels will be implemented in England by an amendment to the Feeding Stuffs (England) Regulations 2005.
• There is a parallel measure, which will be subject to a separate consultation, for residues of coccidiostats in animal products for human consumption, to reflect the potential for their carry-over from feed into milk, meat and eggs.

Coccidiostats are substances intended to help prevent coccidiosis - i.e., infestations of the gastro-intestinal tract by certain single-celled micro-organisms (protozoa), mainly in poultry - which are authorised under EC Regulation 1831/2003 on feed additives. Authorisations under this Regulation typically set the conditions of use, such as the species for which the specific products are intended, their maximum inclusion rates in finished feed, and the required labelling declarations.

EC Regulation 183/2005 on feed hygiene lays down specific requirements for feed businesses which use coccidiostats. In particular, they must take measures to avoid any cross-contamination of their facilities (production, storage, transport and other equipment) to ensure that any residues of these products are not present in feed for species for which they are not authorised (non-target species).

Feed business operators will take measures to minimise the potential for cross-contamination, but in practice the presence of such residues may be technically unavoidable, in particular where feed business operators are manufacturing a range of feedingstuffs within the same establishment and different types of feed products are being turned out on the same production line. This cross-contamination - known as carry-over - typically occurs where residues from one production run are incorporated in the start of the following production run. At present, there are no tolerance levels for such instances of carry-over, although there is a need for harmonised tolerance levels throughout the EU to avoid Member States setting their own, different national limits which would vary depending on their differing analytical capabilities and rates of detection. The setting of different national limits could give rise to difficulties with the operation of the Single Market.

Commission Directive 2009/8/EC of 10 February 2009 lays down risk-based tolerance levels for carry-over. Two rates are set, as follows:

• 3% carry-over in feed for less sensitive non-target species
• 1% carry-over in withdrawal feed (i.e. feed used in the period before slaughter), feed for sensitive non-target species, feed for target species to which coccidiostats and histomonstats are not added, and feed for non-target species classifiable as 'continuous food-producing animals' (such as dairy cows and laying hens). The levels were set following an assessment by the European Food Safety Authority of the likely risks to animal and human health.

The levels are being introduced as maximum permitted levels (MPLs) for a new category of undesirable substances in Schedule 5 to the Feeding Stuffs (England) Regulations 2005 (as amended). This will transpose into national legislation the provisions of the Annex to Directive 2009/8/EC, and is without prejudice to the authorisation of these substances as feed additives under EC Regulation 1831/2003.

There is a parallel measure for the carry-over of residues of coccidiostats into food for human consumption. These tolerances are being introduced by an EC Regulation which will be directly applicable in all Member States and on which Agency colleagues responsible for food contaminants legislation are consulting as part of a consolidation of that legislation.

Consultation Process

Key stakeholders were kept apprised of the content of the draft Directive while it was under discussion at the Standing Committee in Brussels. The FSA is now formally consulting on the draft Feed (Specified Undesirable Substances) (England) Regulations 2009 to transpose the Directive's provisions into law in England. (There will be separate but parallel consultations in Scotland, Wales and Northern Ireland.) The issues on which we would like stakeholders' views are set out in the box immediately below. Comments from small businesses are particularly requested.

1. Comments on the maximum permitted levels set out in the Schedule to the draft Feed (Specified Undesirable Substances) (England) Regulations 2009.
2. Information on the potential benefits of the introduction of maximum permitted levels for residues of coccidostats in feed for non-target species. It would be helpful if these benefits could be quantified in monetary terms, wherever possible.
3. Comments on the assumption that there will be no new costs associated with the introduction of these maximum permitted levels.
4. The ability of laboratories to analyse down to the maximum permitted levels to be introduced by the draft Regulations.
5. Comments from enforcement authorities in particular on the potential impact on their work of the new maximum permitted levels, including any potential reduction in the frequency of sampling and analysis. It would be helpful to have this quantified in monetary terms, wherever possible.
6. Any other comments stakeholders may have on the draft Feed (Specified Undesirable Substances) (England) Regulations 2009.

All comments received will be summarised and published online as part of the post-consultation action unless stakeholders particularly request that their comments be treated as confidential. Comment may be made by post, by fax, or by e-mail.

Other Relevant Documents

The Directive, which the draft Regulations are intended to transpose is published on the Commission's website, can be found at the link below.

Responses

Responses are requested no later than 15 June 2009. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation or company (including details of any stakeholders your organisation represents).

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