FSA Consultation Document, 25 June 2010
A copy of the consultation document is available on this site. See: FSA Food Irradiation Consultation
To seek views on the proposed amending Regulations, to make businesses and enforcement authorities aware of the new facilities and to provide opportunity for interested parties to comment on the proposals. Responses are requested by: 6 August 2010
Who will this consultation be of most interest to?
The proposed Regulations are relevant to irradiation facilities, importers of the seven permitted categories of food or manufacturers of products using these ingredients, enforcement authorities and consumer interest groups.
What is the subject of this consultation?
The Food Irradiation (England) (Amendment) Regulations 2010, amending the The Food Irradiation (England) Regulations 2009. To make statutory provision to implement Commission Decision 2010/172/EU, which adds three food irradiation facilities in India to the list of approved third-country (non-EU) food irradiation facilities. The list of approved EU member state facilities will also be updated to reflect the recent changes.
What is the purpose of this consultation?
To seek views on the proposed amending Regulations, to make businesses and enforcement authorities aware of the new facilities and to provide opportunity for interested parties to comment on the proposals.
The Food Standards Agency welcomes your comments on the proposed Food Irradiation (England) (Amendment) Regulations 2010, enclosed as Annexe B. The proposed Regulations will implement Commission Decision 2010/172/EU ('the EU Decision'), regarding the approved list of food irradiation facilities outside the EU. This Decision amends Decision 2002/840/EC by adding the three facilities in India to the list of approved facilities. The EU Decision requires immediate implementation.
The EU Decision has been in force since 29 March 2010. We are conducting a six-week consultation to seek comments from interested parties to ensure that the EU decision is implemented as soon as possible. We welcome your comments on the way in which the proposed Food Irradiation (England) (Amendment) Regulations 2010 will implement these provisions. A further delay could result in the UK Government being cited for infraction proceedings. But we will try to accommodate those needing more time if it is essential.
The Food Standards Agency in Scotland, Wales and Northern Ireland will each consult on parallel but separate Regulations that will apply in their territories.
The process of treating food with ionising radiation (X-rays, gamma rays or beams of electrons) (referred to as 'food irradiation') has been permitted in the UK since 1991. Food Irradiation and the importation and sale of food so treated (referred to as 'irradiated food') are currently controlled under European Directive 1999/2/EC relating to foods and food ingredients treated with ionising radiation. The provisions of Directive 1999/2/EC are fully implemented in England by The Food Irradiation (England) Regulations 2009 (SI 2009/1584).
Article 9 of Directive 1999/2/EC states that irradiated food must not be imported from a third-country (non-EU) unless it originates from a facility approved by the European Community. Article 9 also includes the procedures by which new facilities can be approved. In 2008, three facilities in India were inspected under these procedures. Commission Decision 2010/172/EU, which amends Decision 2002/840/EC as regards the list of approved food irradiation facilities outside the European Union, was published on 23 March 2010 and added the three facilities to the list of approved facilities. These proposed Regulations provide for the implementation in England of Commission Decision 2010/172/EU.
Although food irradiation is not widely utilised in the UK, it is gaining favour in parts of the world, such as the USA, India and the Far East. It is therefore important that we ensure our procedures for accepting food irradiated outside the European Union meet the legal standards set in EU legislation.
The following section explains in detail the rationale behind the new Regulations.
Implement Commission Decision 2010/172/EC
Article 9 of Directive 1999/2/EC states that irradiated food must not be imported from a third country unless it originates from a facility approved by the European Community. Article 9 also includes the procedures by which new facilities can be approved. In 2008, three facilities in India were satisfactorily inspected under these procedures.
These Regulations will amend Schedule 4 (List of facilities outside the European Community) to the Food Irradiation (England) Regulations 2009 to include the three new facilities in India. They provide for the implementation in England of Commission Decision 2010/172/EU amending Decision 2002/840/EC as regards the list of approved facilities in third countries for the irradiation of foods.
Update the list of Member State facilities in Schedule 3
Article 7(4) of Directive 1999/2/EC requires the European Commission to publish details of Member State facilities and any changes in their status in the Official Journal (OJ). These details were initially published in the C Series of the OJ, but since 2004 have been replaced by a list published solely on the Commission website. Schedule 3 to the Food Irradiation (England) Regulations 2009 is based on the list previously published on the Commission website and dated 3 September 2004. On 4 January 2010, the list on which Schedule 3 of the 2009 Regulations was based was replaced with the current, undated list.
The position of the Food Standards Agency is that the purpose of Article 7(4) is to produce a definitive list of approved Member State facilities. Although this list is now published on the Commission website and not strictly in accordance with the requirements of Article 7(4), it is clear that the Commission intends that these website lists are nevertheless treated as the definitive list according to Article 7(4). As such, this list, and any changes to it, must be implemented into our national legislation by updating Schedule 3 of the 2009 Regulations.
If these changes were not implemented in our national legislation, irradiated food from the three newly listed Member State facilities, each approved by the relevant Member State in accordance with Article 7 of Directive 1999/2/EC, would not be permitted by the 2009 Regulations, which would obstruct legitimate free trade within the European Union.
Minor drafting improvement to Schedule 2 (Licences)
This proposal also makes a minor drafting improvement in Schedule 2 (Licences) to The Food Irradiation (England) Regulations 2009. This amendment is in Part 3 (Requirements and prohibitions to be observed by a licensee) of Schedule 2 and will replace the words in paragraph 9(1)(b) with 'its batch number' instead of making reference to 'the number given to it under paragraph 4'. This does not change the meaning of the provision but improves its clarity.
This proposal was recommended by the Scottish Parliament's Subordinate Legislation Committee during scrutiny of their parallel legislation to the 2009 Regulations and is likewise being included in the English draft as the text is identical in this respect in the English Regulations.
A full 12-week public consultation on the 2009 Regulations, which this draft SI will amend, was undertaken between 29 January and 27 April 2009. This six-week public consultation provides interested parties with the opportunity to comment on the proposed amending SI.
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.
Questions asked in this consultation:
Do you have any objection to any of these facilities in the amended Schedules 3 and 4 being included as approved food irradiation facilities (for example, do you have evidence that the correct procedures for approval have not been met in any of these cases)? Please provide evidence to support your views.
Do you think that any aspects of the legislation will be difficult to implement or could be implemented in a more simplified, less burdensome manner? Please provide evidence to support your views.
Do you think that there are any alternatives to introducing legislation which could achieve the same result of ensuring irradiated food is only sold where it originates from an approved facility? Please provide evidence to support your views.
Do you agree with our opinion that there will be no impact to business or enforcement authorities as a result of these proposals? Please provide evidence to support your views.
Do you have any general comments/issues of concern with these proposals?
We would welcome comments from all stakeholders, but in particular those in 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. Although the Agency does not anticipate any new or additional costs arising from the proposals discussed here, it always helps us to provide the full picture of any burdens (particularly administrative burdens) placed upon those affected by the proposals. Please send your response by email or post using the contact details above.
Responses are required by close 6 August 2010.