This consultation started on 2nd December 2009 and ends on 27th February 2009.
The draft Contaminants in Food Regulations (Northern Ireland) 2009 propose to make provisions for the enforcement authorities in Northern Ireland 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 Northern Ireland Regulations will also provide for the enforcement in Northern Ireland 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 Regulations (Northern Ireland) 2007 (S.R. 2007 No. 66) as amended by the Contaminants in Food (Amendment) Regulations (Northern Ireland) 2007 (S.R. 2007 No. 443), 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 have 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 Regulations (Northern Ireland) 2007 as amended by the Contaminants in Food (Amendment) Regulations (Northern Ireland) 2007 and remake them with necessary amendments.to devolve responsibility for the enforcement in Northern Ireland 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 (Northern Ireland) 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 9th 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 23 July 2008 although some of the provisions of this Regulation will not apply until 1st 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 England, Scotland and Wales 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 Annex 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 27 February 2009Target date for the coming into force of the Regulations 30 April 2009Submitting comments on the draft Regulations We would welcome your comments on the proposed Regulations at Annex 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 Section 1 in the Annex. For the UK the derogation applies until 31 December 2008. The current expectation is that the derogation is unlikely to be renewed and that the nitrate levels for lettuce and spinach will instead be relaxed so that the derogation is no longer necessary. A new nitrate limit may also be introduced for rucola (rocket). This is one of three options discussed at the most recent Agricultural Contaminants 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 it is agreed, then references to Articles 7(1) and 7(2) of the Commission Regulation at regulation 2 of the proposed Regulations will be amended to reflect this.
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 Regulations (Northern Ireland) 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 (Northern Ireland) 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 district councils and those with port health functions.
The guidance notes have been produced to provide formal non-binding advice on the requirements of the Contaminants in Food Regulations (Northern Ireland) 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 guidancethe layout of the guidancethe clarity of the guidancewhether 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.The following documents relating to this consultation are available: Draft Contaminants in Food Regulations (Northern Ireland) 2009
http://www.tellthemwhatyouthink.org/consultation/con-1714-draft-contaminants-food-ireland-2009
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