FSA Consultation Document, 14 June 2010
A copy of the FSA Consultation Document is available on this website. See: FSA Draft Contaiminants Regulation
We welcome your comments on the proposed Contaminants in Food (England) Regulations 2010, enclosed as Annex D, which provide enforcement authorities with the necessary Statutory Instrument (SI) to ensure compliance with the new Commission Regulation and for the devolvement of enforcement powers to the enforcement authorities. Responses are requested by: 23 July 2010
Who will this consultation be of most interest to?
The proposed Regulations are aimed at any food business operator involved in placing on the market the products covered under the European Regulation.
What is the subject of this consultation?
The draft Contaminants in Food (England) Regulations 2010 provide for the statutory enforcement of Commission Regulation (EU) No. 165/2010 that sets maximum levels for certain contaminants in foodstuffs (e.g. aflatoxins) and revoke and remake, with appropriate changes, the Contaminants in Food (England) Regulations 2009.
What is the purpose of this consultation?
To provide an opportunity for interested parties to comment on the draft Regulations and their impact.
European Regulations are directly applicable in Member States from the date of application specified in them, provisions must be made for their execution and enforcement. The proposed Regulations have been developed for this purpose. The proposed Regulations will revoke the Contaminants in Food (England) Regulations 2009 and remake them with necessary amendments, taking into account the provisions of the new Commission Regulation (EU) No. 165/2010, which are already applicable as from 8 March 2010.
We are therefore conducting this short six week consultation to seek comments from interested parties on the draft SI and its impact Offices of the Food Standards Agency in Scotland, Wales and Northern Ireland will each consult on parallel but separate Regulations that will apply in those territories.
1. European Union (EU) legislation on contaminants in food is made under the contaminants in food framework Regulation, Council Regulation 315/93/EEC. The Regulation lays down the EU procedures for contaminants in food and applies general requirements to those contaminants that are not covered by specific EU measures. In order to continue to reduce the disparities between the existing laws of the Member States concerning the maximum limits for contaminants in certain foodstuffs and the consequent risk of distortion of competition, Commission Regulation (EC) No. 1881/2006 was introduced under Council Regulation 315/93/EEC to ensure market unity while also applying the principle of proportionality. The provisions and requirements of Commission Regulation (EC) No. 1881/2006 (and its predecessor Regulation (EC) No. 466/2001) have applied across the EU since April 2002.
2. Commission Regulation (EC) No. 165/2010 of 26 February 2010 amending Regulation (EC) No. 1881/2006 setting maximum levels for certain contaminants in foodstuffs as regards aflatoxins ('the new Commission Regulation') was published in the Official Journal (OJ) of the European Union (EU) on 27 February 2010 (OJ L 50 27.02.2010 p. 8-12). It came into force on 8 March 2010 and applied as from that date. The new Commission Regulation is directly applicable throughout the EU. A copy of the Regulation is attached as Annex E to this letter and is also available to download free of charge.
3. The intention of Commission Regulation (EC) No. 1881/2006 is to provide consumers with an increased measure of protection by setting maximum levels for mycotoxins and undesirable process and environmental contaminants in those foodstuffs that are significant contributors to the dietary exposure of consumers to those particular contaminants. The Regulation aims to exclude grossly contaminated 3 food from entering the food chain and harmonise Member States‟ existing measures, thus facilitating trade. Maximum levels are currently set in legislation for lead, cadmium, mercury, inorganic tin, dioxins, polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons (PAHs), nitrate, 3-MCPD, aflatoxins, ochratoxin A, patulin and Fusarium toxins.
4. In view of the requirements to protect public health by keeping contaminants at levels that are toxicologically acceptable, the European Commission under a rolling programme investigates whether limits should be set for additional contaminants and/or for foods and also reviews the maximum levels for those contaminants currently in the legislation. Summary of changes to European Regulation (EC) No. 1881/2006
5. Regulation (EC) No. 1881/2006 sets maximum levels for certain contaminants in foodstuffs. The new Commission Regulation aligns EU limits for total aflatoxins in hazelnuts, almonds and pistachios with those agreed at the Codex Committee on Contaminants in Food in 2008. Separate limits for aflatoxin B1 will be retained in the interim. There are also additional limits for oil seeds and rice for further processing.
6. This letter seeks your view and comments on changes to the English legislation necessary to apply revised EU measures on maximum levels for certain contaminants in foodstuffs.
7. During the course of negotiations with the European Commission, officials of the Food Standards Agency ('the Agency') have regularly consulted interested organisations including industry, research institutes, consumer groups, enforcement authorities and any other parties with an interest in policy issues relating to contaminants in food. Under UK legislative procedures the views of interested parties are taken into consideration to inform our voting position when Regulations are being discussed in the EU. Interested parties will already be aware of the changes introduced by the new Commission Regulation as they have been consulted via interested parties letters on the possible implications of the EU measures under the 'rapidly developing policy' section on the Agency‟s website.
8. Copies of the draft documents and EU Regulations have been made available for comments and views. Where such measures do not require 4 enforcement or implementation in England, these are picked up by ambulatory references. The 2009 contaminants Regulations contain such references, the aim of which is to reduce the regulatory burden on business and enforcement authorities by ensuring that no additional amending Regulations or new Regulations are required to make enforcement provisions for amendments to Commission Regulation 1881/2006.
9. The letters are published on the Agency's website and can be accessed at the following link: http://www.food.gov.uk/foodindustry/regulation/europeleg/euupdates/
10. This consultation is not being held for 12 weeks due to the timing and the need to have the enforcement SI in place as soon as possible. It has not been possible to carry out a lengthy consultation as there was a very short interval between the publication of the new Commission Regulation and its application from the 8 March 2010. However a full 12-week public consultation was undertaken between the 2 December 2008 and 10 April 2009 on the Regulations that this instrument updates. We have therefore to make Regulations to provide for the enforcement of Commission Regulation 1881/2006 as amended by the new Commission Regulation. If the provisions are not in place, then the new Commission Regulation cannot be enforced and the United Kingdom could be open to infraction proceedings by the European Commission.
Questions asked in this consultation:
(1). It is our assumption that there is a familiarisation cost for enforcement authorities associated with the proposed Regulations. We invite enforcement authorities to comment on our estimate of one hour for familiarisation and a further hour for reading the new Regulations. If you disagree with this assessment, please provide evidence to support your views.
(2). It is our assumption that there is a familiarisation cost for industry associated with the proposed Regulations. We invite businesses to comment on our estimate of one hour for familiarisation and a further hour for reading the new Regulations. If you disagree with this assessment, please provide evidence to support your views.
(3). It is our assumption that there are no new or additional administrative burdens associated with the proposed Regulations. Is this an accurate assessment for both enforcement authorities and businesses? If you disagree, please provide evidence to support you views.
11. We would now welcome comments on the proposed Regulations in so far as they relate to the enforcement provisions of the new Commission Regulation. We would also welcome comments on any costs likely to be incurred in implementing the enforcement proposals. Although costs arising from the need to comply with the new Commission Regulation are not strictly part of the consultation, any that can be provided will help us to provide a full picture of any burdens (particularly administrative burdens) placed upon those affected by the proposals. The costs relating to the new Commission Regulation itself should be shown under separate headings from those attributable to the enforcement issues that are the subject of this consultation. If these costs are indivisible or unquantifiable, this should be made clear.
12. We believe that there are no new or additional costs to businesses or enforcement authorities associated with the proposal to implement the enforcement provisions of the European Regulation in England, other than those mentioned above. If you disagree with this assessment, please provide evidence as appropriate on financial costs associated with the proposed English Regulations and/or the Commission Regulation to support your view(s).
13. Any other comments you are able to provide in relation to the proposed Regulations would be helpful. We would be particularly keen to hear from small businesses on any likely impact of the Regulations and would encourage them to comment on all aspects of the proposal and its intended effect.