The Feeding Stuffs (Establishments and Intermediaries) (Amendment) (Wales) Regulations 2005

Tuesday 8 November 2005

Regulatory Impact Assessment

Background
1. These Regulations transpose and implement, in Wales, Commission Decision 98/728/EC of 14 December 1998, which requires Member States to charge feed businesses for the costs of approving their premises under Directive 95/69/EC. This reflects the additional work involved in the approval of premises compared with registration.

2. Council Directive 95/69/EC introduced a system for the approval or registration of establishments and intermediaires (premises) that manufacture, market or use certain feed additives (e.g. vitamins and trace elements), or protein products (e.g. amino acids). Premises must comply with standards relating to equipment, quality control, personnel, storage and record keeping. Generally premises subject to approval are those carrying out higher risk activities. Approval requires prior inspection of the premises concerned before the relevant activity can commence, while registration involves placing premises on a list with follow up checks.

3. Most of the requirements of Council Directive 95/69/EC have been implemented in the UK by the Feedingstuffs (Establishments and Intermediaries) Regulations 1999 (as amended). However, the provisions of the Decision concerning the approval of premises carrying out activities relating to zootechnical activities (e.g. growth promoters) have been implemented through separate legislation made by the Department for Environment, Food and Rural Affairs (Defra) (The Feedingstuffs (Zootechnical Products) Regulation 1999 as amended (SI No. 1871.)).

Purpose and Intended Effect of the Measures
4. The Feeding Stuffs (Establishment and Intermediaries) (Amendment) (Wales) Regulations 2005 will transpose Decision 98/728/EC into domestic legislation and set fees for the approval of premises engaged in the various types of activities, identified in paragraph 2 above, that are subject to approval.

Risk Assessment
5. The proposed Regulations allow local authorities to recoup the additional costs associated with the approval of premises. Generally premises subject to approval are those carrying out high risk activities and have to comply with standards relating to equipment, quality control, personnel, storage and record keeping. If such premises were not subject to approval issues of public health and feed/food safety may arise.

Options
6. In respect of this legislation, the "Do nothing option" is not an option as it would lead ultimately to infraction proceedings against the National for Wales by the European Commission. Therefore, the "Make the legislation" option, to implement the changes required to comply with European legislation, is being implemented.

Benefits
7. There would appear to be no identifiable social, economic or environmental benefits or disadvantages arising from the full implementation of Decision 98/728/EC.

Costs
8. There are no financial implications for the Assembly from the making of these Regulations.

9. Only new businesses manufacturing and selling certain non zootechnical feed additives and pre-mixtures and protein products will be subject to fees under these Regulations and the Local Authorities Co-ordinators of Regulatory Services (LACORS) (the co-ordinating body for Local Authority Trading Standards Departments in England and Wales) estimate that there may only be about five new applications across England, Scotland and Wales per annum. The fees consist of a flat rate and are set at
226 for intermediaries or
451 for manufacturers.

10. Enforcement of this legislation is the responsibility of local authorities in Wales. LACORS and the Welsh Local Government Association were included in the consultation and invited to identify and comment on any additional costs they may envisage. No comments were made by either organisation to the exercise. It is not anticipated these proposals will impose any additional burdens. In fact the Regulations will allow local authorities to recoup the additional costs associated with the approval of premises.

Equality and Fairness
11. No issues of equity or fairness have been identified.

Consultation with Small Businesses (The Small Firms Impact Test)
12. The Federation of Small Businesses was included in the consultation on the draft Regulations but did not respond. The proposed measure will apply equally across all businesses that require approval and there is no indication that the charges will affect small businesses to a lesser or greater extent than medium sized or large ones.

Enforcement, Sanctions, Monitoring and Review
13. Enforcement of the Regulations is the responsibility of Local Authorities in Wales and the current arrangements will remain unchanged. The Food Standards Agency will monitor the impact of these proposals.

Consultation

With Stakeholders
14. The Food Standards Agency Wales carried out a consultation from 13 October 2004 to 5 January 2005. Forty-six stakeholders including LACORS, consumer and industry representative bodies and farming unions were invited to comment on the draft Regulations and any costs associated with the implementation of the Regulations (a full list of consultees is below at Annex A).

15. Only one response was received in Wales from the Welsh Consumer Council who had no comment to make on this occasion. Parallel consultations were carried out in England, Scotland and Northern Ireland and nine responses were received UK wide. Five of these amounted to �no comments� and the remaining responses including those from the Association of Public Analysts and LACORS did not raise any significant issues, but supported the provisions of the Regulations. Therefore no policy changes to the draft Regulations were identified as a consequence of the public consultation.

With Subject Committee
16. There has been no prior scrutiny of the proposed Regulations by the Health and Social Services Committee, but the Regulations were notified to the Committee via the list of forthcoming legislation on 6 October 2004 (HSS(2)-11-04 (p. 5b), item FSA No. 42(03)). The Regulations were not identified for detailed scrutiny.

Summary and Recommendations
17. The Food Standards Agency believes that the full implementation of the proposals will provide essential consumer health protection. Support for the adoption of these proposals is recommended.

Contact Point
Jayne Griffiths
Food Standards Agency Wales
11th Floor, Southgate House
Wood Street, Cardiff CF10 1EW
Telephone: 029 2067 8908
Fax: 029 2067 8918
E-mail: jayne.griffiths@foodstandards.gsi.gov.uk