COMMISSION DECISION
of 9 July 1999
on protective measures with regard to contamination by dioxins of certain products of animal origin intended for human or animal consumption
(notified under document number C(1999) 2110)
(Text with EEA relevance)
(1999/449/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market(1), as last amended by Directive 92/118/EEC(2), and in particular Article 9(4) thereof,
Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animal and products with a view to the completion of the internal market(3), as last amended by Directive 92/118/EEC, and in particular Article 10(4) thereof,
Whereas:
(1) Commission Decision 1999/363/EC of 3 June 1999 on protective measures with regards to contamination by dioxins of certain animal products intended for human or animal consumption(4), as last amended by Decision 1999/419/EC(5), and Commission Decision 1999/389/EC of 11 June 1999 on protective measures with regards to contamination by dioxins of products intended for human consumption derived from bovine animals and pigs and revoking Decision 1999/368/EC(6), as last amended by Decision 1999/419/EC, have each been substantially amended. Since further amendments are to be made, they should be recast in a single decision in the interests of clarity and rationalisation.
(2) On 27 May 1999, the Belgian authorities informed the Commission of a case of heavy contamination of compound feedingstuffs with dioxins. Those feedingstuffs had been distributed to a considerable number of domestic fowl farms in Belgium (some 25 %) from 15 January 1999 onwards.
(3) From 26 May 1999, the Belgian authorities placed restrictions on all the domestic fowl holdings which had received those feedingstuffs. The Belgian authorities prohibited the slaughter of poultry from 1 June 1999. Products intended for human or animal consumption derived from animals reared in those farms before that date may still be on the market.
(4) On 2 June 1999, the Belgian authorities informed the Commission that they had placed restrictions on some 500 pig holdings which may have received contaminated feedingstuffs. On 3 June 1999, they also informed the Commission that contaminated feedingstuffs had been distributed to a number of bovine holdings as well. The Belgian authorities have taken actions on pigs and bovine animals and derived products similar to those applied in the case of poultry and, in particular, they have prohibited the slaughter of bovine animals and pigs from 3 June 1999.
(5) It appears that those feedingstuffs, live animals which had been fed therewith and products derived from those animals have been traded to other Member States and third countries. Other animal species may have been fed with those contaminated feedingstuffs. Investigation of the responsibility for this contamination is continuing. The Community inspection in Belgium on 8 to 11 June 1999 concluded that, on the basis of the available results of analyses, a massive contamination occurred over a limited time, rather than a recurring problem.
(6) In the light of the foregoing, it is necessary to take measures to protect the health of consumers. The measures should apply to domestic fowl, pigs and bovine animals reared in Belgium from 15 January onwards and to products derived therefrom. The measures should not apply to products derived from animals which have not been reared in holdings placed under restriction by the Belgian authorities or which have been shown by analyses not to be contaminated by dioxins. Provision should be made for those products to be destroyed in a manner that ensures that they cannot enter the human food or animal feed chains. It is not yet appropriate to set an end-date for the application of the measures. In order to prevent deflections of trade, the measures should also apply to exports to third countries. All relevant information should be supplied to the Commission, the Member States and third countries, where appropriate by means of the rapid alert system set up by Council Directive 92/59/EEC of 29 June 1992 on general product safety(7). For the purposes of intra-community trade and exports to third countries, a system of certificates should be established for consignments of Belgian origin. It is necessary that Belgium and Member States which received products derived from animals which have been reared in holdings placed under restriction establish a monitoring plan to evaluate the presence of contamination of dioxins/polychlorinated biphenyls (PCBs) in products of animal origin. Inspections should be carried out by the Commission in order to verify the implementation of this Decision.
(7) It appears to be difficult to trace back the exact origin of certain Belgian products and, in particular, products derived from domestic fowl produced between 15 January 1999 and 1 June 1999 and products derived from bovine animals and pigs produced between 15 January 1999 and 3 June 1999. The Belgian authorities are prepared to accept the return of those products from Member States in application of Article 7 of Directive 89/662/EC. It is necessary to lay down strict and specific rules on the procedure to be followed when the products are returned to Belgium in order to ensure that they cannot re-enter the human food or animal feed chains before they are submitted to appropriate checks to verify their safety. Considering that the Belgian authorities informed the Commission of difficulties in using the ANIMO network set up by Council Directive 91/398/EC(8), it is appropriate to inform directly by means of telefax the Belgian central competent authority of the return of the products.
(8) Article 15 of Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(9) establishes specific rules for the re-importation of consignments of products of Community origin which have been refused by a third country. It is necessary to establish that products returned from third countries to Belgium cannot re-enter the human food or animal feed chains before they are submitted to the appropriate checks to verify their safety.
(9) Council Directive 1999/29/EEC of 22 April 1999 on the undesirable substances and products in animal nutrition(10) provides that feed materials may only be put into circulation in the Community if they are sound, genuine and of merchantable quality,
(10) The body of toxicological and epidemiological evidence available today has led the International Agency for Research on Cancer (IARC) of the World Health Organisation (WHO) to consider tetrachlordibenzo-dioxin (TCDD) a class 1 carcinogen (the highest class in the IARC ranking). The WHO has recommended that a tolerable daily intake (TDI) of 14 pg/kg bw/day be respected for dioxins. No limits for dioxin contamination have been set for individual commodities and food products. Data on background levels of contamination do exist. In the absence of limits for dioxins at international, Community or national level, the data on background levels should be used as references. The analysis of dioxins requires sophisticated methods which are available only in a limited number of laboratories in the Member States.
(11) On 11 June 1999 a Commission working group on PCBs as markers for dioxin contamination concluded that the levels of seven persistent PCBs in eggs and poultry-meat products can be used reliably as a surrogate for dioxins. Furthermore, it concluded that an action level of 200 ng PCB (sum of 7 congeners)/g fat be used for poultry products. On 16 June 1999 the Scientific Committee for Food adopted an opinion on dioxins in milk derived from cattle fed on contaminated feed in Belgium. In its opinion, the Committee stressed the need to analyse milk samples from all dairy farms placed under restriction by the Belgian authority, individually, at least for PCBs, using an adequate limit of quantification, as an indicator for a possible dioxin contamination, above background. For this purpose, the Committee recommended that an action level of 100 ng PCB (sum of 7 congeners)/g fat be used for milk and milk products. This action level should be applied for screening purpose for raw milk from the individual farms in question, for bulked milk from dairies, and for any milk products manufactured since the date of known contamination of animal feed. Where the levels above 100 ng PCB/g fat are found, this should trigger analysis for dioxins. The Committee and the Commission working group stressed those action levels are only intended to apply in the context of the present particular situation in Belgium and should not be taken as an endorsement of a permanent limit for PCBs in the products concerned.
(12) In compliance with the above scientific opinion of 16 June 1999, the Belgian authorities carried out individual analyses of raw milk from all the 234 individual farms placed under restriction, bulked milk from dairies, and milk products manufactured since the date of known contamination of animal feed. The results indicated that, with the exception of 9 farms, the current and past products from 225 farms have no health significance for the consumers. Considering these results, it is appropriate to remove milk and milk products from the scope of Decision 1999/389/EC. However, in accordance with the recommendation of the Scientific Committee for Food, it is necessary to maintain under restriction the products from dairy farms where the action level for milk is exceeded until the results of analysis demonstrate that the milk is not contaminated with dioxins.
(13) On 28 and 29 June 1999 a Commission working group on the PCB/dioxin contamination of the Belgian food supply considered the adequacy of a threshold of 2 % of fat below which the foodstuffs subject to the provision of Decisions 1999/363/EC and 1999/389/EC would be exempted from the scope of those Decisions. That working group concluded that, in the light of the abovementioned opinion of the Scientific Food Committee and considering the data available so far on PCBs and dioxins in Belgian products, it is reasonable to assume, in the case of egg products containing less than 10 % of egg fat it is unlikely that their presence in amounts below 2 % increases PCB and dioxins intake significantly above background levels.
(14) Article 9(4) of Directive 89/662/EEC and Article 10(4) of Directive 90/425/EEC authorise the Commission to adopt safeguard measures for animals and products referred to in Article 1 and, if the situation so requires, products or products derived from those products. Therefore, these measures can also cover incidentally other products which are not included in Annex I to the Treaty. The situation as regards the dioxin contamination justifies such measures.
(15) Article 3 of Decision 1999/363/EC and Article 3 of Decision 1999/389/EC established measures for Member States which received products of Belgian origin covered by those Decisions. Discussions with Member States have revealed that there are problems of implementation and interpretation of those provisions and they should therefore be clarified.
(16) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
HAS ADOPTED THIS DECISION:
Article 1
1. A. Belgium shall prohibit the placing on the market, including distribution to the final consumer, the trade and the export to third countries, of the products listed below which are intended for human or animal consumption and are derived from domestic fowl reared in Belgium between 15 January 1999 and 1 June 1999 or from pigs and bovine animals reared in Belgium between 15 January 1999 and 3 June 1999:
- fresh poultrymeat, as defined by Council Directive 71/118/EEC(11);
- fresh meat, as defined by Council Directive 64/433/EEC(12);
- mechanically recovered meat;
- minced meat and meat preparation, as defined by Council Directive 94/65/EC(13);
- meat products and other products of animal origin as defined by Council Directive 77/99/EEC(14);
- products intended for human consumption which contain other products of bovine, porcine or poultry origin as defined by Council Directive 77/99/EEC, which contain more that 2 % of animal fat, with the exclusion of milk fat,
- eggs;
- egg products, as defined by Council Directive 89/437/EEC(15), with the exclusion of egg white;
- products intended for human consumption which contain more than 2 % of eggs or more than 2 % of egg products containing more than 10 % of egg fat;
- rendered fats, as referred to in Directive 92/118/EEC;
- processed animal proteins, as referred to in Directive 92/118/EEC;
- raw material for the manufacture of animal feedingstuffs, as referred to by Council Directive 92/118/EC,
- compound feedingstuffs and pre-mixtures.
B. Belgium shall maintain under restriction raw milk collected after 12 June 1999, and heat treated milk and milk based products derived therefrom, from holding which, whenever tested, did not comply with the limits set in Annex A, until such time as the result of analysis demonstrate that the milk is not contaminated with dioxins.
2. The prohibition set out in paragraph 1A. shall not apply where:
(a) the products are not derived from animals reared in holdings put under restriction by the Belgian authorities;
or
(b) the results of analysis demonstrate that the products are not contaminated with dioxins or, that they do not exceed the levels for PCBs set out in Annex A.
3. Belgium shall prohibit the placing on the market, the trade and the export to third countries of live domestic fowls reared between 15 January 1999 and l June 1999 or hatching eggs laid by those domestic fowls during that period and of pigs and bovine animals reared between 15 January 1999 and 3 June 1999, unless the animals have not been reared and the eggs have not been produced in holdings placed under restrictions by the Belgian authorities.
4. Belgium shall ensure that all the products referred to in paragraph 1 which do not fulfil the conditions laid down in paragraph 2 are destroyed by means approved by the competent authorities in a manner that ensures that they cannot enter the human food or animal feed chain.
5. Belgium shall inform immediately the Commission and the Member States, if appropriate by means of the rapid alert system under Directive 92/59/EEC, and third countries which have received the live animals, hatching eggs referred to in paragraph 3 or products covered by paragraph 4 of this Article;
6. Belgium shall investigate:
(a) possible remaining stocks of contaminated feedingstuffs,
and
(b) possible distribution of contaminated feedingstuffs with dioxins to other farm animals and to other Member States and third countries.
It shall inform without delay the Commission and other Member States and third countries concerned of the results of such investigations.
7. Belgium shall monitor the level of dioxins in Belgian products of animal origin.
For this purpose, Belgium shall submit without delay a monitoring plan to the Commission.
8. Belgium shall keep the Commission and the Member States informed of the results of its investigation into the source of the contamination of feedingstuffs by dioxins.
Article 2
1. For the purpose of infra-Community trade and export to third countries, in addition to the appropriate commercial document or to the official certificate, each consignment of products of Belgian origin listed in Article 1(1)(A) must be accompanied by an official certificate signed by the Belgian competent authority as laid down in Annex B.
2. For the purpose of infra-Community trade and export to third countries, the appropriate health certificate accompanying each consignment of live domestic fowl and hatching eggs derived therefrom, of Belgian origin must be accompanied by an official declaration signed by the Belgian competent authority as laid down in Annex C.
3. For the purpose of infra-Community trade and export to third countries, the appropriate health certificate accompanying each consignment of bovine animals and pigs of Belgian origin must be accompanied by an official declaration signed by the Belgian competent authority as laid down in Annex D.
4. The official certificate and the official declarations referred to in paragraphs 1, 2 and 3 shall be drawn up on the date of loading in the language or languages of the Member State of dispatch and in the official language of the Member State of destination and they shall consist of a single sheet.
Article 3
Member States which have received feedingstuffs suspected of being contaminated with dioxins, live animals or hatching eggs which have been reared or produced in holdings placed under restrictions by the Belgian authorities and/or products of Belgian origin covered by Article 1(4), shall immediately:
(a) carry out an investigation into the distribution of those feedingstuffs and into possible remaining stocks;
(b) trace and place restrictions on those animals and hatching eggs and products arising therefrom;
(c) trace back all products derived from animals fed with those feedingstuffs, and products listed in Article 1(1)(A) destined for human or animal consumption which contain those products;
(d) trace back all products of Belgian origin to which this Decision applies, and products listed in Article 1(1)(A) which are destined for human or animal consumption containing those products of Belgian origin;
(e) ensure that the products referred to in points (a) to (d) are destroyed by a means approved by the competent authority in a manner that ensures that they cannot enter the human food or animal feed chain, unless it can be proved they are not contaminated with dioxins or, that they do not exceed the levels for PCB set out in Annex A;
(f) inform immediately the Commission and the Member States, if appropriate by means of the rapid alert system under Directive 92/59/EEC, and third countries concerned on the findings of their investigation and on the eventual actions taken;
(g) monitor the level of dioxins in products of animal origin.
For this purpose, the Member States concerned shall without delay submit a monitoring plan to the Commission.
Article 4
On request of a Member State or of a third country which has received live animals, hatching eggs or products listed in Article 1(1)(A) and Article 1(3) before 12 June 1999, Belgium, where it has such information, shall provide a declaration on the status of the holding of origin in accordance with the model set out in Annex E.
Article 5
1. By way of derogation from Article 3(e), in accordance with Article 7 of Directive 89/662/EEC, Member States may return products of Belgian origin to which Article 1(1)(A) applies to Belgium in cases where, following the application of Article 4, it has not been possible to trace the exact Belgian holdings of origin and where analyses of the products for dioxins or PCBs have not been carried out.
2. Paragraph 1 shall apply only if the following conditions are fulfilled:
(a) Belgium must have authorised in writing the return of the product indicating the exact address of the establishment to which the products must be returned
(b) the product must be accompanied by an official certificate as laid down in Annex F to this Decision and by a copy of the commercial document or the health certificate which accompanied the product from Belgium to the Member State concerned;
(c) the products must be transported in containers or vehicles sealed by the competent authority of the Member State concerned in such a manner that the seals will be broken whenever the container or the vehicle is opened;
(d) the products must be conveyed directly to the establishment referred to in point(a);
(e) Member States which return products to Belgium must inform by telefax the competent authority in charge of the establishment referred to in point (a), of the place of origin and of the place of destination of the returned product giving the details laid down in the Annex to Decision 91/637/EC(16). The words "Product returned in accordance with Article 5 of Decision 1999/449/EC" must be contained in the fax;
(f) Belgium must send confirmation by fax of the arrival of each consignment to the competent authority of the Member State which returned the product;
(g) Belgium must ensure that the returned product is placed under restriction until its destruction by a means approved by the competent authority in a manner that ensures that it cannot enter the human food or animal feed chain or until the results of analysis demonstrate that the product is not contaminated with dioxins or, that it does not exceed the levels for PCB set out in Annex A to Decision 1999/449/EC;
3. Belgium shall keep full records demonstrating compliance with paragraph 2.
Article 6
Belgium shall ensure that the products of Belgian origin which are re-imported into Belgium from third countries in accordance with the conditions laid down in Article 15 of Directive 97/78/EC, are placed under restriction until their destruction by a means approved by the competent authority in a manner that ensures that they cannot enter the human food or animal feed chain. or until the results of analysis demonstrate that the products are not contaminated with dioxins or, that they do not exceed the levels for PCBs set out in Annex A.
Belgium shall keep full records demonstrating compliance with this Article.
Article 7
Commission inspections may be carried out in order to verify the implementation of this Decision.
Article 8
Member States shall adopt the necessary measures to bring their trade rules into conformity with this Decision. They shall immediately inform the Commission thereof.
Article 9
This Decision may be reviewed in the light of the results of Commission inspections and of information received by Member States.
Article 10
Decision 1999/363/EC and Decision 1999/389/EC are repealed.
Article 11
This Decision is addressed to the Member States.
Done at Brussels, 9 July 1999.