Business and Regulatory Impact Assessment on Commission Regulation (EU) No. 1276/2011 amending Annex III to Regulation (EC) No. 853/2004 – the treatment to kill viable parasites in fishery products

Introduction
EU food hygiene legislation introduced in 2006 required that fishery products intended to be consumed raw or almost raw, and certain cold smoked and marinated/salted fishery products, must undergo a freezing treatment to kill any parasites that may pose a risk to consumers, unless there is sufficient epidemiological evidence to demonstrate that there is no health hazard with regard to parasites.

Recent scientific evidence suggests that the risks to human health from parasites in farmed fish are minimal, and there is no longer a clear public health case for continuing to require the freezing of farmed fishery products intended to be consumed raw or almost raw. The EU food hygiene legislation has therefore been amended to introduce more risk-based freezing controls, and the FSA has produced a draft impact assessment to assess the costs, benefits and wider impacts for stakeholders.

Background
Research carried out by the FSA in Scotland found that the risks to human health from Anisakid nematodes in farmed Atlantic salmon are negligible¹. The European Food Safety Authority (EFSA) reached a similar conclusion when it evaluated the FSA research as part of a wider assessment of the risks associated with parasites in fishery products, published in March 2010².

Following publication of the ESFA opinion, the European Commission proposed an amendment to Regulation (EC) No. 853/2004 to introduce more risk-based freezing controls. The proposal was discussed extensively at working group level before a final draft amendment was presented for vote at the Standing Committee on the Food Chain and Animal Health (SCOFCAH) on 12 July 2011. This received the support of the majority of member states, including the UK. Following three month scrutiny by the European Parliament and the Council, the regulation was adopted and came into force on 29 December 2011, 20 days after publication in the Official Journal of the European Union.

Throughout negotiations Scottish stakeholders were fully consulted on the draft proposal to inform the UK negotiating position. This helped shape the outcome of the final proposal.

Commission Regulation (EU) No. 1276/2011
The main change introduced by Commission Regulation (EU) No. 1276/2011 is an amendment to Regulation (EC) No. 853/2004 to allow food business operators to make evidence-based freezing exemptions for farmed fishery products reared under certain controlled conditions. A freezing exemption will be available for farmed fishery products that have been cultured from embryos and have been fed exclusively on a diet that cannot contain viable parasites that present a health hazard, and have been exclusively reared in an environment that is free from parasites, or where food business operators can verify through procedures, approved by the competent authority, that they do not present a health hazard with regard to the presence of viable parasites.

In addition, the regulation will introduce more risk-based controls for cold smoked fish by extending the freezing requirement to all species of fish that have not undergone, or are not intended before consumption to undergo, a heat treatment sufficient to kill viable parasites. In the case of parasites other than trematodes this is a treatment of 60°C for at least one minute. Prior to this amendment Regulation (EC) No. 853/2004 only required that cold smoked herring, mackerel, sprat and wild Atlantic and Pacific salmon need to be frozen before consumption.

Key changes:

• To provide a specific freezing exemption for farmed fishery products that are intended to be consumed raw, cold smoked or marinated/salted.
• To extend the freezing requirements for cold smoked fishery products to all species of fish that have not undergone, or are not intended before consumption to undergo, a heat treatment sufficient to kill viable parasites.

Endnotes
¹ Petrie, A, et al. A Survey of Anisakis and Pseudoterranova in Scottish fisheries and the efficacy of current detection methods: Food Standards Agency in Scotland, Study S14008, 2007
² See link below.

There has been extensive ongoing communication and consultation with stakeholders as negotiations on the draft Commission regulation progressed. An informal UK-wide consultation on the draft proposal was issued to 180 stakeholders in January 2011, and four responses were received from key stakeholders and affected businesses. In addition, individual meetings have been held with key stakeholder organisations and affected Scottish businesses from the production, processing and retail sectors to discuss the proposals and inform development of an impact assessment.

The FSA in Scotland has now produced a partial business & regulatory impact assessment to assess the costs, benefits and wider impacts for stakeholders on which we would welcome any comments. The Food Standards Agency in Scotland would particularly welcome comments from stakeholders involved in the supply, processing or retailing of fishery products intended for raw consumption that are derived from farmed fish, who are likely to benefit from the new freezing exemption. We would also welcome comments from stakeholders involved in cold smoking wild species that will now be subject to freezing controls for the first time.

This consultation is not being held for a full 12 weeks, since its purpose is primarily to seek comments to help refine the data which itself was gathered from key stakeholders during full consultation on the Commission regulation and development of the BRIA. The shortened consultation will enable the final stage of consultation with stakeholders to be completed prior to making of the domestic implementing legislation in accordance with Scottish regulatory procedure.

Parallel consultations will take place in England, Wales and Northern Ireland on a UK impact assessment.

Responses are required by close 22 February 2012. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/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