Draft Contaminants in Food (England) Regulations 2009

Consultation extended to 10 April 2009

On 2 December 2008 the Food Standards Agency launched a consultation on the proposed draft Contaminants in Food (England) Regulations 2009 to implement the enforcement provisions of two new Commission Regulations amending Regulation (EC) No. 1881/2006, which sets maximum levels for certain contaminants in foodstuffs. In particular, Commission Regulation (EC) No, 565/2008 establishes a maximum level for dioxins and PCBs in fish liver. The proposals for England also provide for the enforcement of Commission Regulation (EC) No. 629/2008, setting maximum levels for certain other contaminants in foodstuffs.

The European Commissions Standing on the Food Chain and Animal Health has adopted a proposal for a new Commission Regulation setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed.

Commission Regulation (EC) No. 124/2009 was published in the Official Journal (OJ) of the European Communities on 11 February 2009 (OJ Ref: l40, 11.02.2009, pg 7) setting maximum levels for the presence of coccidiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed. The Regulation is applicable throughout the EU and will come into force on 2 March 2009 and apply from 1 July 2009. The Commission Regulation can be found at the link below.

The main provisions of the Commission Regulation to be as we summarise below. This will also result in new insertions in the proposed Contaminants in Food (England) Regulations 2009, which are also discussed below.

Background

Coccidiostats and histomonostats are veterinary medicines authorised for use in animal feeds. The Veterinary Medicines Direct (VMD) normally lead on any regulatory issues, such as maximum residue limits (MRLs) in formulated feeds and resulting limits in food. Because the European Commission’s concern about the possible carry-over into batches of feed that are not intentionally formulated with coccidiostats or histomonostats they have felt it necessary to introduce a Directive limiting the permissible amount of coccidiostat carry-over into feed, and at the same time, a Regulation limiting the resulting residue in food of non-target animals.

The unavoidable carry-over in non-target feed of active substances contained in authorised coccidiostats and histomonostats are considered as undesirable substances in animal feed within the meaning of Directive 2002/32/EC and their presence should not endanger animal health, human health or the environment. Therefore, maximum levels for these substances in animal feed are established by a Commission Directive amending Annexe I to Directive 2002/32/EC.

Council Regulation (EEC) No. 315/93 lays down Community procedures for contaminants in food and it has therefore been amended to establish a provision for food of animal origin contaminated by the non-target feed concerned. The provisions of Regulation (EC) No. 124/2009 are made under Council Regulation (EEC) No. 315/93, which lays down the Community procedures for contaminants in food. These contaminants are defined as:

• 'any substance not intentionally added to food which is present in such food as a result of its production and processing, preparation and treatment etc (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food, or as a result of environmental contamination. Extraneous matter, such as, for example, insects, fragments, animal hair, etc, is not covered by this definition.'

Regulation (EC) No. 124/2009 (the Commission Regulation) setting maximum levels for the presence of coccodiostats or histomonostats in food resulting from the unavoidable carry-over of these substances in non-target feed

A copy of the Commission Regulation can be found in Annexe B at the link below. The main changes introduced are:

• Article 1(1) provides that the foodstuffs listed in Annexe to the new Regulation shall not be placed on the market where they contain a contaminant listed in this Annexe at a level exceeding the maximum levels set in the Annexe.
• In case of a finding of a significant residue below the maximum level set out in the Annexe, it is appropriate for the competent authority to carry out investigations to confirm that the residue is present as a consequence of unavoidable carry over in the feed and not as the consequence of illegal administration of the coccidiostat or histomonostat.
• Foodstuffs complying with the maximum levels set out in the Annexe shall not be mixed with foodstuffs which exceed these maximum levels.
• Article 1(2) – when applying the maximum levels set out in the Annexe to this Regulation to foodstuffs which are dried, by diluted, processed or composed of more than one ingredient, changes of the concentration of the contaminant caused by drying, diluting or processing, as well as the relative proportion of the ingredients in the product shall be taken into account.
• Article 1(3) – the maximum levels established in Annexe to the new Regulation are without prejudice to the provisions and the MRLs (maximum residual levels) established by Council Regulation (EEC) No. 2377/90 and the MRLS established by Regulation (EC) No. 1831/2003.
• Article 3 provides that the new Regulation shall enter into force on the twentieth day following publication in the OJ, will apply from 1 July 2009 and is binding in its entirety and applicable throughout the EU.

Changes to the draft Regulations

A copy of the latest draft of the Contaminants in Food (England) Regulations 2009 is enclosed at Annexe A. The main change introduced by the insertion into the draft Regulations are at:

• regulation 2(1), and 2(2) interpretation;
• regulation 3(2)(c) offences and penalties;
• regulation 4(1) relating to the enforcement and 4(2)(b) on competent authorities of the new Commission Regulation and regulation;

The consultation period has been extended for a further eight weeks to take into account the new provisions of the Commission Regulation and the proposed revised Regulations for England. Comments on this insertion into the draft Regulations and the revised Impact Assessment should now be made by 10 April 2009.

Submitting comments on the draft Regulations

We would welcome comments on the insertions as outlined at paragraph 7 above of the draft Regulations that relate to England. We would also welcome comments on any likely costs to you of implementing these provisions. Although we do not anticipate any cost implications arising from this insertion into the proposed Regulations, we are happy to receive any information to the contrary from you so that our Impact Assessment reflects the true situation for businesses and enforcement authorities.

Submitting comments on the Impact Assessment (IA)

We would welcome comments on the revised IA at Annexe C. We do not consider that the newly inserted provisions outlined at paragraph 7 above are likely to change the requirements of the Regulation nor introduce any additional burden. The proposed Regulations merely provide for the enforcement of the Commission Regulations by the enforcement authorities. However, we would welcome your comments if you disagree with this assessment and can provide evidence to support your views.

The draft Contaminants in Food (England) Regulations 2009 propose to make provisions for the enforcement authorities in England to enforce the requirements of new Commission Regulations amending Regulation (EC) No. 1881/2006, which sets maximum levels for certain contaminants in foodstuffs. In particular, Commission Regulation (EC) No. 565/2008 establishes a maximum level for dioxins and PCBs in fish liver. The proposals in the draft England Regulations will also provide for the enforcement in England of Commission Regulation (EC) No. 629/2008, setting maximum levels for certain other contaminants in foodstuffs. The draft Regulations will revoke the Contaminants in Food (England) Regulations 2007 (SI 2007/210) as amended by the Contaminants in Food (England) (Amendment) (No.2) Regulations 2007 (SI 2007/2983), and remake them with necessary amendments. The proposed Regulations also introduce the use of ambulatory references. An ambulatory reference is a provision in UK legislation that allows future amendments to specified EC legislation to take effect in national law without having to be specifically implemented or enforced via new domestic regulations. The aim of using ambulatory provisions is to reduce the regulatory burden on those that refer to the Regulations, such as enforcement authorities, businesses and others with an interest in the legislation.

The key proposals are:

• to revoke the Contaminants in Food (England) Regulations 2007 as amended by the Contaminants in Food (England) (Amendment) (No.2) Regulations 2007 and remake them with necessary amendments.
• to devolve responsibility for the enforcement in England of Regulation (EC) No.s 565/2008 and 629/2008.
• to introduce the use of ambulatory references in the domestic Regulations.

Responses are required by 27 February 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.

Detail of consultation
We would welcome your comments on the proposed draft Contaminants in Food (England) Regulations 2009, attached below.

Commission Regulation (EC) No. 565/2008 of 18 June 2008 amending Regulation (EC) No. 1881/2006 was published in the Official Journal (OJ) of the European Union (EU) on 19 June 2008 (OJ L160 19.06.2008 p.20-21). It came into force on 9 July 2008 but applies retrospectively from 1 July 2008. Commission Regulation (EC) No. 629/2008 of 2 July 2008, amending Regulation (EC) No. 1881/2006 was published in the OJ on 3 July 2008 (OJ L173 03.07.2008 p.6-9). It came into force on 23rd July 2008 although some of the provisions of this Regulation will not apply until 1 July 2009. Both European Regulations are directly applicable throughout the EU. A copy of each of the European Regulations is attached below.

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

Comments are also requested on the draft guidance notes (attached at Annexe I), that will accompany the proposed Regulations. When submitting comments, please indicate whether you are commenting on the guidance or the draft Regulations.

Background
European Community (EC) legislation on contaminants in food is made under the contaminants in food framework Regulation, Council Regulation 315/93/EEC. The Regulation lays down community procedures for contaminants in food and applies to those contaminants that are not covered by other specific community measures. In view of the disparities between the existing laws of 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 (previously Regulation (EC) No. 466/2001) have applied across the EU since April 2002.

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 process and environmental contaminants in those foodstuffs that are significant contributors to the total 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 requirement to protect public health by keeping contaminants at levels that are toxicologically acceptable, the European Commission 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 the changes to European Regulation (EC) No. 1881/2006
Regulation (EC) No. 1881/2006 sets maximum levels for certain contaminants in foodstuffs. Since 2006 very high levels of dioxins and dioxin-like PCBs have been reported in canned fish liver and have been reported through the European Commission’s Rapid Alert System for Feed and Food (RASFF) system. Previously, no maximum level has been established for fish liver nor its processed products. In the interest of public health competent authorities banned the placing on the market of those products because they were deemed unsafe. Consequently, it has been deemed necessary to set a community-wide maximum level for the sum of dioxins and dioxin-like PCBs in fish liver and processed products to protect public health and to ensure a uniform approach in the internal market while enabling trade to continue.

The amending Regulation (EC) No. 565/2008 establishes a maximum level for dioxins plus PCBs in fish liver. The limit set also takes into account the specific canning process for fish liver and provides that the limit must also apply to processed liver.

As regards Commission Regulation (EC) No.629/2008, new information indicates that even good agricultural and fisheries practices do not ensure that levels of lead, cadmium and mercury in certain aquatic species and certain species of fungi are as low as is required in the Annex to Regulation 1881/2006. Therefore it is expedient to revise the maximum levels fixed for those contaminants, while maintaining a high level of consumer protection.

High levels of lead, cadmium and mercury have been found in certain food supplements, which have been notified through the RASFF system. It has been shown that these food supplements, particularly with regard to cadmium which readily accumulates in seaweed, can contribute significantly to human exposure to lead, cadmium and mercury. In order to protect public health, it has been deemed necessary to set maximum levels for metals. The maximum levels set in the amending Regulation, are as safe and as low as reasonably achievable based upon good manufacturing practices. To allow Member States and food business operators’ sufficient time to adapt to the new maximum levels for food supplements, the application of the new levels for food supplements is deferred until 1 July 2009.

Who will be affected by the new regulations?
The primary business sectors affected by the new Commission Regulations will be those in the fishing, agricultural and food supplement manufacturing industries. 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 contaminants in food legislation, including the maximum levels for contaminants in food and they will also be affected by the proposals. Charities and voluntary organisations are unaffected by them.

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

• Public consultation starts Tuesday 2 December 2008 (12 weeks)
• Public consultation ends Friday 10 April 2009 (Originally Friday 27 February 2009)
• Target date for the coming into force of the Regulations 30 April 2009

Submitting comments on the draft Regulations
We would welcome your comments on the proposed Regulations at Annexe A in so far as they relate to the provisions for the enforcement of the new Commission Regulations. We would also welcome your comments on the introduction of ambulatory references in the proposed Regulations, the aim of which is to reduce the regulatory burden on enforcement authorities as well as industry by ensuring that no additional amending Regulations or new Regulations are required to make enforcement provisions for amendments in future to the Annex to Commission Regulation 1881/2006. This in turn will reduce costs and time taken by enforcement authorities and industry to read and understand the Regulations and significantly reduce the time and cost borne by central government in preparing and/or amending new Regulations.

Article 7 of Commission Regulation 1881/2006 provides for temporary derogations for placing on the market of fresh spinach and lettuce grown and intended for consumption in their territory with nitrate levels higher than the maximum levels set out in point in the Annexe. For the UK the authorisation the derogation is until 31st December 2008. The current expectation is that the derogation is unlikely to be renewed and that the nitrate levels for lettuce and spinach will be relaxed, with a new nitrate limit introduced for rucola (rocket. This is one of three options discussed at the last Agricultural Working group meeting in Brussels. This proposal is likely to go to the Standing Committee of the Food Chain and Animal Health on 12 December 2008. If the proposal is agreed, then the definition of the Commission Regulation in Regulation 2 of the proposed Regulations will be amended accordingly.

Although the costs arising from the need to comply with the requirements of the two European Regulations setting maximum levels for certain contaminants in foodstuffs are not strictly part of the Impact Assessment here, it is always helpful to provide a full picture of any burdens, including administrative burdens or those that may be considered necessary to check for compliance, placed upon those affected by the proposals. Where the costs for compliance relate to the two European Regulations, they should be shown under separate headings from those attributable to the draft Contaminants in Food (England) Regulations 2009 that are the subject of this consultation. If these costs are indivisible or unquantifiable, it would be helpful to have this made clear. Please provide documentary evidence to support your view if you disagree with our assessment.

Industry guidance on the draft Contaminants in Food (England) Regulations 2009
We would also welcome your comments on the industry guidance (attached at Annex I). The guidance is aimed primarily at businesses involved in the placing on the market of foods for which there is European harmonised community legislation in respect of contaminants in food. It may also be of use to others with an interest in the legislation, such as local authorities and port health authorities.

The guidance notes have been produced to provide formal non-binding advice on the requirements of the Contaminants in Food (England) Regulations 2009 and should be read in conjunction with the legislation itself. The text should not be taken as authoritative statement or interpretation of the law. Every effort has been made to ensure that the guidance notes are as helpful as possible. However, it is ultimately the responsibility of individual businesses to ensure compliance with the law. The guidance notes take into account the amending provisions of Regulation (EC) No. 1881/2006, which sets maximum levels for certain contaminants in foodstuffs.

In particular, we would welcome your views on:

• the content and form of the guidance
• the layout of the guidance
• the clarity of the guidance
• whether any more simplified guidance is needed for small businesses or for particular business sectors and, if so, what form you think that guidance should take.

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