Last updated on 15 June 2010
The Draft Contaminants in Food Regulations (Scotland) 2010
We would welcome your comments on the proposed Contaminants in Food (Scotland) Regulations 2010, enclosed as Annex D which will provide enforcement authorities with the necessary Scottish Statutory Instrument (SSI) to ensure compliance with the new Commission Regulation and for the devolvement of enforcement powers to the enforcement authorities.
All comments and views should be sent to
Food Safety Monitoring & Policy Branch
Food Standard Agency in Scotland
6th Floor, St Magnus House
25 Guild Street
Tel: 01224 285146
Fax: 01224 285168
Responses are requested by: 27 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 (Scotland) 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 (Scotland) 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.
Although 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 (Scotland) Regulations 2009 and remake them with necessary amendments, taking into account the provisions of the new Commission Regulation (EU) 165/2010, which are already applicable as from 8th March 2010.
We are therefore conducting this short six week consultation to seek comments from interested parties on the draft SSI and its impact.
The Food Standards Agency in England, Wales and Northern Ireland will each consult on parallel but separate Regulations that will apply in those territories.
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.
Commission Regulation (EC) No. 165/2010 of 26th February 2010 amending Regulation (EC) No. 1881/2006 setting maximum levels of certain contaminants in foodstuffs as regards aflatoxins (“the new Commission Regulation”) was published in the Official Journal (OJ) of the European Union (EU) on 27th February 2010 (OJ 50 27.02.2010 p.8-12). It came into force on 8th 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 from the following website address: http://eurlex.europa.eu/JOIndex.do?year=2010&serie=L&textfield2=50&Submit=Search&_submit=Search&ihmlang=en
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, undesirable processes 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 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.
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
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.
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 Commission Regulation.
Proposed timetable for the New Regulations
Important dates in the introduction of the new Regulations:
- Public consultation starts 15 June 2010 (6 weeks)
- Public consultation ends 27 July 2010
During the course of negotiations with the European Commission, officials of the Food Standards Agency (FSA) 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 EC measures under the ‘rapidly developing policy’ section on the Agency’s website. The letters can be accessed via the link below.
Copies of the draft documents and EU Regulations have been made available for comments and views. Where such measures do not require enforcement or implementation in Scotland, these are picked up by ambulatory references. The 2009 Regulations contains 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.
Criterion 1 of the Cabinet Office Code of Practice states that a written consultation must be held for a minimum of 12 weeks for at least once during the development of the policy. This consultation has been shortened to 6 weeks due to timing and the need to have the enforcement SSI in place as soon as possible following the European Regulation coming into force on 8th March 2010. However a full 12-week public consultation was undertaken between the 5th December 2008 and 2nd March 2009 on the Regulations that this instrument updates. A full twelve week consultation on this occasion was in any event not considered necessary or appropriate. We have therefore to provide a SSI, to provide for the enforcement of this Regulation; make provisions for penalties, offences/defences and for the devolvement of enforcement powers to the enforcement authorities. If the provisions are not in place, then the European Regulation cannot be enforced and the United Kingdom could be open to infraction proceedings by the European Commission.
Questions asked in this consultation:
- 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.
- 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.
- 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.
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 dealt with in the proposed Regulations for Scotland, which are subject of this consultation. If these costs are indivisible or unquantifiable, this should be made clear.
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 Commission Regulation in Scotland, other than those mentioned above. If you disagree with this assessment, please provide evidence as appropriate on financial costs associated with the proposed Scottish Regulations and/or the Commission Regulation to support your view(s).
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.
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.
Publication of personal data and confidentiality of responses
In accordance with the FSA principle of openness we shall keep a copy of the completed consultation and responses, to be made available to the public on request. 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.
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: firstname.lastname@example.org