Food Law News - EU - 2005

FSA Scotland Letter, 1 February 2005

CONTAMINANTS – Update on issues relating to heavy metals and PCBs

The following is a text of a letter from Fiona Bruce, Contaminants, Hygiene, Additives & Shellfish Branch, FSA Scotland

1) Recently Published European Community (EC) Legislation: (a) Commission Regulation (EC) No 78/2005 of 19 January 2005 amending Regulation (EC) 466/2001 as regards heavy metals; (b) Commission Directive 2005/4/EC of 19 January 2005 amending Directive 2001/22/EC laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs

2) Commission Working Group meeting of 24 January 2005 : Dioxins and Dioxin-like PCBs

1) EC Legislation

(a) Commission Regulation (EC) No 78/2005, amending Regulation 466/2001

As you are aware, the European Commission is currently carrying out a review of Commission Regulation 466/2001. The review included proposals for a number of changes to the fish categories in respect to heavy metals and a proposed revised higher limit for cadmium in swordfish (my letters of March to October 2004 refer).

The proposals were agreed and adopted. The list of fish has been modified to include a list of the main traded species and the maximum limit for cadmium in swordfish is now 0.3 mg/kg wet weight. Commission Regulation 78/2005 which makes provision for these revisions has recently been published in the Official Journal of the European Union (OJ) – reference 20.1.2005 L 16/43. The Regulation, which is directly applicable in Member States, will enter into force on the 20th day following the date of its publication.

(b) Commission Directive 2005/4/EC, amending Directive 2001/22/EC

In my letter of July 2004, I informed you of discussions at Working Group level on proposals to amend Commission Directive 2001/22/EC which lays down the procedures for sampling and analysis for the official control of lead, cadmium, mercury and 3-MCPD in foodstuffs. Commission Directive 2005/4/EC has recently been published in the OJ – reference 21.1.2005 L 19/50. The Directive, which applies to enforcement authorities and specifically to Public Analysts, includes updated standard information for contaminants in food, and in particular takes into account the measurement uncertainty for analysis. The Directive will enter into force on the 20th day following the date of its publication.

Next Steps

A Scottish Statutory Instrument (SSI) is now required to make provision for the enactment and enforcement of the Regulation and implement the Directive into national legislation. The Agency will carry out a formal consultation on the draft SSI in due course. In the meantime copies of this new EC legislation are available from the Commission's website at

The Commission Regulation amending Regulation 466/2001 in regards to PAHs and the allied enforcement sampling and analysis Directive have not yet been published. I will notify you once they have been published in the OJ by way of an Interested Parties letter.

2) Proposals for Dioxins and Dioxin-like PCBs

In my letter of 11 January, I updated you on the progress of the Commission's proposals to include maximum levels for dioxin-like PCBs in the legislation. I had noted that there were some outstanding issues still under discussion. During the Working Group meeting on 24 January, the Commission signalled that it wished to finalise a draft amending Regulation (SANCO/00305/2005) at the next Standing Committee meeting on 14 February so that the document could go out to wider consultation.

2.1 General Issues

Although the majority of Member States supported the proposal that for a transitional period the current dioxin limits would be maintained in addition to the Total TEQ limits some Member States continued to voice their concerns. The Commission explained that this was a transitional measure to ensure that there was no relaxation of the current position and that in future the legislation would only limit Total TEQ.

One Member State stated that this interim proposal added complexity to the legislation but the Commission noted that as long as the testing is done by GC/MS (gas chromatography/mass spectrometry), results for dioxins and PCBs would be available. Other Member States voiced concerns about a lack of laboratory capacity to measure PCBs. Other concerns included the proposed fish limit as applied to eels and whether there was a public health concern in respect to this species, which is not eaten widely. One Member State suggested that the Toxic Equivalent Factor (TEF) table should be included in the new regulation. The Commission thought it would be helpful, since the limits were based on this particular set, other Member States expressed support.

2.2 Total TEQ for Fish Oil

The Working Group agreed that the Total TEQ limit for fish oil should be returned to the originally proposed 10 pg/g fat to reflect the current situation – an earlier draft Working Paper had proposed a limit of 8 pg/g fat. The Commission agreed to return the marine oil limit (which includes fish oil) to 10 pg/g fat, in line with the approach to other foods and animal feeds.

2.3 Derogation for Baltic Fish

Sweden and Finland have a derogation, until 31 December 2006 , on the current dioxins legislation (please see Council Regulation 2375/2001 Article 1(1a) for details). The Commission presented two options – either a general derogation for Sweden and Finland to market fish from the Baltic or a derogation covering certain fish species – notably Baltic salmon, Baltic Sea herring and river lamprey. There was also a provision for the derogation to be extended to Estonia . The three Member States concerned signalled that they preferred the second option, which was accepted by the Commission. The other Baltic States ( Latvia , Poland and Lithuania ) have also asked for the derogation. The Commission will consider these requests further.

2.4 Proposed limits for baby food and infant formula

On 7 January I advised you that an initial proposal to set separate limits for infant and baby food had received little support from Member States and this food category had been removed. However, one Member State has made a fresh request for the draft Regulation to include tight limits for dioxins and PCBs in baby food. Although some Member States understood the concerns regarding this vulnerable group, the request again received little support and it was re-iterated that the main burden remains on the mother and that the emphasis should be to reduce levels in all foods.

It was proposed that more monitoring rather than higher limits should take place and that the monitoring Recommendation should include the following text ‘….particular attention will be paid to the necessity of setting specific lower maximum levels….in foods for infants and young children'.

Next Steps

A draft initial Regulatory Impact Assessment is currently being prepared and will be circulated under cover of the Interested Parties letter following Standing Committee. I would be grateful for your comments and views on the finalised draft legislation, and in particular on the potential costs that may arise from this proposal. You will wish to note that the completion of the review of the dioxin limits has been postponed to 31 December 2007 .

Date of next meeting

The next Dioxin Working Group is scheduled for 7 and 8 March, at which time representations from stakeholders may be made.

2.5 Monitoring Recommendation (2004/705/EC) and target levels

A new Recommendation will replace Commission Recommendation 2004/705/EC on the monitoring of background levels of dioxins and dioxin-like PCBs. The new Recommendation, which will be discussed in detail at the next Working Group meeting, will include the new Member States and will have a provision for action levels for food only (feed action levels are included in the animal feeds limit directive).

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