Background
Commission Decision 1999/724 was adopted on 28 October 1999 following the opinion of the EU Scientific Steering Committee on the safety of gelatine as regards BSE infectivity and associated geographical risk, and came into force on 1 June 2000. The Commission Decision sets out the conditions for intra-Community trade (i.e. between Member States) and imports from third countries of raw materials and gelatine for human consumption. In practice, the Decision places controls on the export to other Member States of gelatine and raw materials for the manufacture of gelatine for human consumption.
The Food Standards Agency wrote to industry and enforcement bodies on 23 August 2000 notifying them that responsibility for implementing Commission Decision 1999/724 had transferred from MAFF to the Agency. We also advised recipients that draft legislation enacting the provisions of the Commission Decision was being developed prior to formal public consultation. That letter also reminded recipients of the correspondence from MAFF dated 23 November 1999 and 8 June 2000 which encouraged industry to comply with the requirements of the Commission Decision.
The production of gelatine for pharmaceutical, cosmetic, medical devices or other technical use is not covered by Commission Decision 1999/724 or by these proposed Regulations.
The draft Gelatine (Intra-Community Trade) (England) Regulations 2001
The draft Regulations will require all collection centres and tanneries that store hides and skins for the manufacture of gelatine for human consumption and that wish to trade in these items to meet certain specified criteria. They will also need to be authorised and registered by the local food authority. Similarly, all those who trade in gelatine for human consumption (eg manufacturers and blenders) will also need to be authorised and registered by the local food authority. The draft Regulations provide for the Food Standards Agency (FSA) to keep a list of those premises authorised and registered to trade as collection centres and tanneries handling hides and skins for the manufacture of gelatine for human consumption, and of premises authorised to trade as manufacturers/blenders of gelatine for human consumption. Commission Decision 1999/724/EC prohibits, for trade purposes, the use of hides and skins submitted to the tanning process in the manufacture of gelatine for human consumption. More information about the specific requirements of the draft Regulations, including what information will be held on the lists of authorised premises, are available from the FSA.
The hygienic manufacture of gelatine for the national market only will continue to be covered by the Food Safety (General Food Hygiene) Regulations 1995, as amended.
Proposed implementation in England
We propose to implement Commission Decision 1999/724/EC in England in two parts. The first part of the implementation of this Decision is the introduction of the Gelatine (Intra-Community Trade) (England) Regulations 2001. These Regulations will add Commission Decision 1999/724 to the list in Schedule 3, paragraph 12 of the Products of Animal Origin (Import and Export) Regulations 1996. Schedule 3 lists the Community measures relevant to intra-Community trade and will give effect to the relevant requirements contained in the Commission Decision in relation to gelatine and raw materials traded with Member States. The Regulations will also set out the specific requirements for the authorisation of collection centres and tanneries handling and supplying raw materials for use in the manufacture of gelatine, as required under part II of paragraph 8(a)-(d) inclusive of the Annex. This is necessary as, up to now, there has been no provision relating to the authorisation of such premises in either UK or EC law.
Second, the requirements of Part VII of the Annex to Commission Decision 1999/724 laying down requirements for gelatine from third countries will be implemented as part of MAFF's revised Products of Animal Origin (Third Country Import) (England and Wales) Regulations 2001. MAFF's timetable for the introduction of these Regulations is May/June 2001. In the meantime imports of raw materials and of gelatine from third countries will need to be accompanied by the relevant health certificate provided for in Commission Decision 2000/20 establishing health certificates for the importation from third countries of gelatine intended for human consumption and of raw materials destined for the production of gelatine intended for human consumption. These health certificates include a declaration to be signed by the official veterinarian of the exporting country that the relevant provisions of Council Directive 92/118/EEC have been complied with.
Guidance Notes
We believe that the provisions of the Decision are clear. Therefore, we do not think that detailed Guidance will be required. Nevertheless it is our intention to issue some general guidance on how the requirements of the Decision have been implemented. This will include guidance on enforcement. We would welcome views at this stage on any specific issues where guidance on the Regulations would be helpful.
The draft Regulatory Impact Assessment
The draft Regulatory Impact Assessment considers possible costs to industry and enforcement resulting from the implementation of these Regulations. Any further information on the likely compliance and implementation costs would be welcomed. The RIA will be finalised following consultation.
Next Steps
A copy of this letter is being sent to local food authorities with tanneries, collection centres, gelatine manufacturers or blenders in their area as they will want to get in touch with the these premises (if they have not already done so) to discuss with them the requirements they need to meet for trade purposes. When these premises meet the relevant requirements for authorisation, the local food authority should send an appropriate letter of authorisation to the companies concerned. Food authorities will also need to send us the relevant details of the premises that they have authorised so that we can compile the list of such premises. The list of registered premises will be placed on the FSA website in due course.
Deadline for comments
Because the small number of organisations that are directly affected by this issue have already been contacted, the consultation period is very short - 4 weeks. Please let me know as soon as possible if this presents problems. Comments should be sent, no later than Friday 23 March,
Devolution
This consultation exercise applies to England only. FSA Scotland, FSA Wales and FSA Northern Ireland are considering separate regulations to implement Commission Decision 1999/724/EC in their respective countries. They will be making their own arrangements for consultation.