Draft Gelatine (Intra-Community Trade) (England) Regulations 2001

We are seeking your views on:

• The draft Gelatine (Intra-Community Trade) (England) Regulations 2001 implementing, in England, certain provisions of Commission Decision 1999/724/EC on the hygienic manufacture of gelatine for human consumption; and
• A draft Regulatory Impact Assessment

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 in the Appendix attached below.

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 (attached below) 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.

A list of parties to whom this consultation document has been sent is attached (at Annex 1). If you are aware of other parties who you believe may have an interest in this issue, please forward a copy of these documents to them. Alternatively, the Agency would be happy to supply further copies on request. Copies of this letter, the draft Regulations, the draft Regulatory Impact Assessment and Commission Decision 1999/724/EC may be obtained from Rosalind Glover at the above address.

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.

Openness
In line with the Agency�s policy of openness and to inform debate on the issues raised by this consultation, we shall make available copies of the comments received. We will assume that the comments you make can be made publicly available unless you indicate otherwise.

Regulation 2: this regulation gives the meaning of certain words and phrases used in these Regulations.

Regulation 3: this regulation amends the Products of Animal Origin (Import and Export) Regulations 1996. Schedule 3 of these Regulations lists the Community measures relevant to intra-Community trade. Adding Commission Decision 1999/724 to the list in paragraph 12 of Schedule 3 implements it, and its requirements, into English legislation. By virtue of this amendment to the Products of Animal Origin (Import and Export) Regulations 1996 the specific requirements, in Commission Decision 1999/724/EC, for the manufacture of and trade in raw materials and gelatine for human consumption are brought into English legislation. The specific requirements include conditions for establishments producing gelatine; requirements for raw materials including their transport and storage; conditions to be complied with for the manufacture of gelatine including the requirements for packaging, storage and transport and for finished products; and requirements for the import of gelatine from third countries.

Regulation 4: this regulation gives power to food authorities in England to authorise those collection centres and tanneries which meet the requirements of the Regulations and which supply, for the purpose of trade, raw materials for the manufacture of gelatine intended for human consumption. When the food authority is satisfied that the premises meets the relevant requirements of these Regulations a distinctive and unique identification number should be issued. This number must appear on the commercial documents that accompany the raw materials. This number will also serve as a means of tracing the premises from which it originated. FSA Guidance to food authorities will suggest that the identification number is in the same format as those issued to premises approved under other product specific hygiene legislation, ie the two local authority identification letters followed by three numbers.

Regulation 5: this regulation gives the food authority the power to suspend or withdraw an authorisation where it is satisfied that the premises in relation to which the authorisation was granted no longer fulfils the relevant requirements of the Regulations. The food authority may also suspend or withdraw an authorisation if he is satisfied that there has been a breach of the Products of Animal Origin (Import and Export) Regulations 1996 which is applicable to any activity carried out at the premises. Before authorisation is suspended or withdrawn the local authority must issue a notice to the proprietor of the business specifying which part or parts of the Regulations are not being complied with. The notice must also give a reasonable time within which full compliance with the Regulations is required. If, at the end of that time, compliance has not been achieved, authorisation may be suspended or withdrawn.

Regulation 6: this regulation provides that the right of appeal against a refusal to authorise, a suspension or withdrawal of authorisation is through a magistrates� court. An appeal may be made within one month of the notice of suspension.

Regulation 7: this regulation allows the proprietor of a food business to ask the food authority to cancel the authorisation of the premises to which the authorisation relates. This might be appropriate if the business ceases to trade, or changes the nature of the business carried on at those premises.

Regulation 8: this regulation the Food Standards Agency will keep a register of all those premises which the food authority has authorised as a collection centre or tannery for the collection or storage of raw materials for the manufacture of gelatine for human consumption.

The Food Standards Agency will also keep a register of all those premises which the food authority has authorised for the manufacture or blending of gelatine for human consumption.

The register will show details of the identification number of the premises, the name and address of the premises, the name of the proprietor and what those premises have been authorised to do, eg to act as a tannery, and the date from which authorisation was given.

Any suspension, withdrawal or cancellation of an authorisation and every other notice issued concerning these premises will be noted on these registers.

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