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Draft Food Irradiation (Wales) Regulations 2009

Thursday 29 January 2009

The proposed Food Irradiation (Wales) Regulations 2009 will replace The Food (Control of Irradiation) Regulations 1990, as amended; in as far as they apply in relation to Wales.

All comments and views should be sent to:

Deb Morgan

Food Safety & Enforcement Division
Food Standards Agency Wales
11th Floor
Southgate House
Wood Street
Cardiff
CF10 1EW

Tel: 029 2067 8938
Fax: 029 2067 8918
E-mail: deb.morgan@foodstandards.gsi.gov.uk

Responses are requested by: 27 April 2009

Consultation details

Following the UK Government's acceptance of the better Regulation Task Force’s report 'Less is More', the Food Standards Agency is developing a rolling programme of regulatory simplification to reduce the administrative burdens of FSA regulations. One of the Agency’s objectives for the near future is to revise existing UK regulations on food irradiation.

The irradiation of food has been shown to be a safe and effective method of preserving food. However, restrictions are in place to ensure high international standards are met and to enable consumer choice at point of sale. Differences between national laws relating to food irradiation (and its conditions of use) hinder the free movement of foods in the European Union (EU) and may create unequal competition, directly affecting the operation of the internal market. Intervention is necessary in order to remove these differences between member states and guarantee a high level of consumer protection.

The food irradiation regulations have been in place for nearly 20 years and have been amended several times. Consolidating the regulations and their amendments into one Statutory Instrument (SI) would make them easier to follow. Amendments to the existing regulations in 2000 were intended to fully implement the requirements of Directive 1999/2/EC and 1999/3/EC. However, these amendments did not adequately address the national procedures relating to food irradiation facilities in non-European countries, and so this must now be corrected. The Agency would also like to take this opportunity to simplify the control system and to do this we would like to change the licensing system and the food irradiation licence issued to irradiation facilities. In addition, the Agency is also considering if licensing and inspection fees are necessary. Finally there are areas where the regulations could be made more up-to-date, for example the definition of cereals. The intention is to reduce the administrative burden for both companies and for enforcement officials.

To this end, the FSA is to produce new food irradiation regulations which provide for the requirements detailed in Directives 1999/2/EC and 1999/3/EC (the food irradiation directives). These Directives must be transposed into domestic law. We would welcome any comments you may have on how this could be done in a more simple and less burdensome way. The Agency does not intend to alter the labelling requirements for irradiated food that are included in the Food Labelling Regulations 1996, as amended.

The key proposals are:

To amend the procedures for the approval of third country (non-EU country) facilities to fully implement Directive 1999/2/EC.
To replace the current licensing system with a simpler system and shorter style licence where most of the legal requirements are contained in the Statutory Instrument, rather than the licence.
No longer charge fees for routine official controls, example fees for licence applications, variations and for inspections.
To consolidate the existing regulations and amendments and make various drafting improvements.

We would welcome your comments on the proposed draft Food Irradiation (England) Regulations 2009, which can be found in Annexe A at the link below. Similar regulations are in the process of being drafted for Wales. They will not differ in content from that provided at Annexe A. For the purposes of this exercise you are asked to comment on Annexe A.

A full 12-week public consultation is being undertaken on the draft SI and associated guidance. During this time, the Agency also proposes to engage with stakeholders on a less formal basis, in particular health food manufacturers where we are aware of concerns over illegally irradiated ingredients. Responses are required by 27 April 2009 . When responding, please state whether you are responding as a private individual or on behalf of an organisation/company (with a brief summary of the people it represents) and where applicable, how the views of members were assembled. All responses received as part of the consultation exercise will be given careful consideration. These will be summarised and published on the Agency’s website in due course.

Detail of the consultation

The following takes each key aim and explains in detail the rationale behind the new regulations:

Approval of third country facilities
The Food (Control of Irradiation) Regulations 1990 allow the UK to 'recognise' food irradiation facilities in third countries, even if they are not approved by the European Community. To do so would be in breach of Article 9 of Directive 199/2/EC. Food that has been irradiated in a third country for sale in the UK must have been irradiated at a facility that has been approved by the Community. The current Regulations are being operated in a way that ensures that the Directive is not breached and no third country food irradiation facilities have been separately 'recognised' by the UK. Never the less, the intention of the regulations is to implement the requirements of the Directive in full.

Approval of UK facilities
Directive 1999/2/EC requires that food irradiation facilities in member states are approved by their national competent authority. In the UK this is the Food Standards Agency. Prior approval of UK facilities is implemented by a licensing system, under which the licence contains conditions required in detail by the regulations. An improvement would be to set out the requirements once, as requirements of the regulations themselves. This would simplify the format of the licence document so that it is concise and where appropriate refers to the regulations on food irradiation without unnecessary duplication of text.

Removal of inspection and approval fees
The Food (Control of Irradiation) Regulations 1990 as amended include measures to collect fees to cover the costs occasioned by official food irradiation controls such as applying for prior approval, varying existing approvals and the inspection of irradiation facilities. However, Official Food and Feed Controls Regulations, to give effect to European Regulation 882/2004, came into force on 1 January 2007 and Article 27 of Regulation 882/2004 establishes the legal basis for the financing of all official food controls. In order to comply with Article 27 the Agency proposes no longer to collect fees to cover the costs of food irradiation controls. However, this should not exclude the collection of fees where additional expenses exceed normal enforcement activities (in line with Article 28 of Regulation 882/2004).

General update to the regulations

Definition of cereals – the current regulations refer to the 'Intervention Functions (Delegation) Regulations 1972' and as these are no longer in force this definition should be removed.
Dried aromatic herbs, spices and vegetable seasonings – one of the permitted categories of food that can be allowed to be irradiated is ‘spices and condiments’. In the interests of clarity this category should be altered to 'dried aromatic herbs, spices and vegetable seasonings', so as to meet the exact description in the Annex of Directive 1999/3/EC.
Food must be in a suitably wholesome state – the current national regulations require that a food irradiation facility specifies what microbiological criteria and the type and frequency of microbiological examination they will use. We propose to change this so that the applicant must show the methods they will use to ensure food is in a 'suitably wholesome state'. This more accurately reflects the requirements of Directive 1999/2/EC and the approach taken in European Regulations 852/2004 and 853/2004 to food hygiene regulation.
The seven categories of food – until a Community positive list of foodstuffs is established, several member states, including the UK, maintain national authorisations of foods which may be treated with ionising radiation. In the UK, seven categories of foods can be irradiated. These are fruit; vegetables; cereals; bulbs and tubers; spices and condiments (amended as dried aromatic herbs, spices and vegetable seasonings); fish and shellfish; and poultry. The Agency does not propose to change the list of foods as part of this update, other than altering the ‘spices and condiments’ category as mentioned above. However, the Agency could consider adding other types of food to the permitted list under Article 4(5) of Directive 1999/2/EC, but only if this food is already on the permitted list of another member state.

The options being considered

Three options have been considered:

Do nothing.
Produce a further amendment to existing Regulations in order to alter domestic regulations.
Revoke existing Regulations and amendments and remake a new Statutory Instrument that fully implements the Directives and consolidates existing food irradiation regulations.

Option [3] is preferred; it is the one that best meets the policy objective of correctly implementing European Directives and simplifying current regulations. This option is in line with the UK Government’s better regulation agenda.

The Food Standards Agency in Scotland, England and Northern Ireland will each consult on parallel but separate regulations that will apply in their territories.

Attached at Annexe B is an Impact Assessment which relates to the parallel regulations that are being prepared in England. A draft Regulatory Impact Assessment is currently being prepared for Wales. For the purpose of this exercise we would welcome your comments on any cost implications that may arise from this proposal as it relates to Wales.

Who will be affected by the draft regulations?

The primary business sectors affected by these proposals are those that operate irradiation facilities, importers of any of the products in the seven permitted categories of food, in particular dried aromatic herbs, spices and vegetable seasonings, or manufacturers of products using these imported ingredients. However, there is currently only one approved food irradiation facility within the UK. This is not in Wales.

These proposals will in principle apply to businesses of all sizes as no exemptions can be made under the European Directive 1999/2/EC. However, there are no small firms operating in the food irradiation market in the UK and the Agency is not aware of any small firms who would be likely to enter the market. Local authorities and port health authorities are responsible for enforcing much of the food safety and food hygiene legislation, they are also responsible for enforcing the provisions of these proposed Regulations, other than those that relate to the licensing of UK food irradiation facilities, and as such they will also be affected by the proposals. Charities and voluntary organisations are unaffected by them.

The potential practical costs to enforcement bodies or industry are very difficult to quantify. It is anticipated that the proposed regulations will be easier for industry in general to use and comply with, and also make the enforcement easier for the enforcement authorities. We would welcome comments and estimates from enforcement bodies of enforcing the new EC legislation.

The potential impact for a one-off cost to businesses is based on the same principles as those for Local Authorities and port health authorities. It is assumed that one person per business reads the regulations and it takes them 45 minutes to do this. In addition, a further 45 minutes may be required to disseminate the requirements of the regulation to key staff within the organisation. We would welcome comments and estimates from industry of ensuring compliance with the new EC legislation.

The proposed new consolidated regulations would remove fees for applications and routine inspections from the irradiation industry to the Food Standards Agency. In addition these proposed regulations will remove the duplicated microbiological testing at the irradiation stage. This will lead to a reduction in storage costs and the potential for increased business by removing one of the barriers to competition with other processing industries.

Questions asked in this consultation:

Q1: Are there any aspects of the legislation that you feel will be difficult to implement?
Q2: Are there any aspects of the legislation you feel could be implemented in a more simplified, less burdensome manner?
Q3: Are there any categories of food you would like to see added to or removed from the list of foods authorised for irradiation in the UK? If you consider the list should be altered, please provide evidence to support your views.
Q4: Any general comments or issues of concern?
Q5: To help us determine whether what we plan is likely to make a substantive contribution to the programme to reduce the administrative burdens, it would be helpful if you could identify any potential cost savings or any cost implications. For example, savings resulting from the introduction of less complex regulations; costs and administrative costs associated with applying for and maintaining a licence to irradiate food. In answering this question, you may also wish to consider the assumptions made and related questions (questions six to eleven) in the Impact Assessment (Annex B).
Q6: Stakeholders are asked to comment on whether the proposed consolidation of these regulations will be easier for business to comply with and make enforcement easier. If you disagree with the above assessment, please provide evidence to support your views.

Proposed timetable for the new regulations
Important dates in the introduction of the new Regulations:

Public consultation starts 27 January 2009 (12 weeks)
Public consultation ends 20 April 2009
Target date for the coming into force of the regulations is the 31 July 2009

Submitting comments on the draft regulations
We welcome comments from all stakeholders, but in particular those within the irradiation industry, those who may import any of the products in the seven permitted categories of food or manufacture products using these imported ingredients and from enforcement authorities. Please send your response by email or post using the contact details above.

Further information

This consultation has been prepared in accordance with the (External) 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.

Download word Consultation feedback questionnaire (Word)

Download pdf Consultation feedback questionnaire (pdf)

Publication of personal data and confidentiality of responses

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.

Download word Data protection form (Word)

Download pdf Data protection form (pdf)

Publication of response summary

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

External links The Food Standards Agency has no responsibility for the content of external websites

(External) Commision Directive 1999/2/EC Gateway to European Union website (External) Commision Directive 1999/3/EC Gateway to European Union website (External) Get Adobe Acrobat reader You may need the free Acrobat Reader to view a pdf

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Draft Food Irradiation (Wales) Regulations 2009

All comments and views should be sent to:

Consultation details

Further information

Publication of personal data and confidentiality of responses

Publication of response summary

Related links

External links The Food Standards Agency has no responsibility for the content of external websites

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