The Government Says

The Feed (Specified Undesirable Substances) (Wales) Regulations 2009 (The Food Standards Agency)

This consultation started on 24th March 2009 and ends on 16th June 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 Wales.

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 feedThese maximum permitted levels will be implemented in England by an amendment to the Feeding Stuffs (Wales) Regulations 2006There 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 that 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 that 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, that 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 species1% 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 (Wales) Regulations 2006 (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 that 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. We are now formally consulting on the draft Feed (Specified Undesirable Substances) (Wales) Regulations 2009 to transpose the Directive's provisions into law in Wales. (There will be separate but parallel consultations in Scotland, England and Northern Ireland.) The issues on which we would like stakeholders' views are set out below. Comments from small businesses are particularly requested.

Comments on the maximum permitted levels set out in the Schedule to the draft Feed (Specified Undesirable Substances) (Wales) Regulations 2009Information 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 possibleComments on the assumption that there will be no new costs associated with the introduction of these maximum permitted levels.The ability of laboratories to analyse down to the maximum permitted levels to be introduced by the draft Regulations.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.Any other comments stakeholders may have on the draft Feed (Specified Undesirable Substances) (Wales) Regulations 2009.

All comments received will be summarised and published on the Food Standards Agency website 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 email.

TGS