COUNCIL DIRECTIVE of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products (89/437/EEC)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,
Having regard to the proposal from the Commission (1),
Having regard to the opinion of the European Parliament (2),
Having regard to the opinion of the Economic and Social Committee (3),
Whereas, in order to ensure the smooth operation of the common market and more especially of the common organization of the market in eggs established by Regulation (EEC) No 2771/75 (4), as last amended by Regulation (EEC) No 3907/87 (5), and of the common system of trade for ovalbumin and lactalbumin introduced by Regulation (EEC) No 2783/75 (6), as amended by Regulation (EEC) No 4001/87 (7), it is essential that the marketing of egg products should no longer be hindered by disparities existing between Member States in respect of health requirements in this area; whereas this will enable production to be better harmonized and bring about competition on equal terms while assuring consumers of a quality product;
(8) OJ No C 67, 14. 3. 1987, p. 9 and OJ No C 53, 2. 3. 1989, p. 10.
(9) OJ No C 187, 18. 7. 1988, p. 184.
(10) OJ No C 232, 31. 8. 1987, p. 1.
(11) OJ No L 282, 1. 11. 1975, p. 49.
(12) OJ No L 370, 30. 12. 1987, p. 14.
(13) OJ No L 282, 1. 11. 1975, p. 104.
(14) OJ No L 377, 31. 12. 1987, p. 44.
Whereas the marketing of certain egg products which are not covered by Annex II to the Treaty is closely linked with the marketing of egg products for which a market organization exists; whereas distortions of competition should be eliminated for all egg products;
Whereas it appears appropriate to exclude from the scope of this Directive egg products which are obtained in small scale enterprises, shops or restaurants and used for the manufacture of foodstuffs intended for direct sale to the final consumer or to be consumed on the spot;
Whereas health requirements should be laid down for the production, storage and transport of egg products; whereas, in particular, it is important that rules be laid down governing the approval of establishments;
Whereas it is important also that the health requirements to be met by egg products be laid down;
Whereas the said rules must apply in an identical manner to intra-Community trade and to trade within the Member States;
Whereas it is the responsibility primarily of producers to ensure that egg products meet the health requirements laid down in this Directive; whereas the competent authorities of the Member States must, by carrying out checks and inspections, see to it that producers comply with the abovementioned requirements; whereas the rules governing these checks and inspections must take account of the demands of the internal market;
Whereas a random check must be made to detect the presence of residues of substances liable to be harmful to human health;
Whereas Community control measures should be introduced to guarantee the uniform application in all Member States of the standards laid down in this Directive;
Whereas, in the context of intra-Community trade, the consignor, the consignee or their representative must be given the opportunity, where a dispute arises with the competent authorities of the Member States of destination, of seeking an expert's opinion;
Whereas egg products manufactured in a third country intended to be placed on the market on Community territory must not qualify for more favourable arrangements than those laid down in this Directive; whereas provision should be made for a Community procedure for inspecting establishments in third countries;
Whereas the Commission should be entrusted with the task of adopting certain measures for implementing this Directive; whereas, to that end, procedures should be laid down introducing close and effective cooperation between the Commission and the Member States within the Standing Veterinary Committee,
HAS ADOPTED THIS DIRECTIVE:
Article 1 This Directive lays down hygiene and health requirements concerning the production and the placing on the market of egg products for direct human consumption or for the manufacture of foodstuffs.
However, this Directive shall not apply to:
- finished foodstuffs manufactured from egg products, as defined in Article 2 and which meet with the provisions of Article 3,
- egg products which are obtained in small scale enterprises and which, without having undergone any treatment, are used for the manufacture of foodstuffs intended for direct sale, without any intermediary, to the consumer or consumed on the spot immediately after having been prepared.
Article 2 For the purposes of this Directive, the definition given in Article 1 (2) of Regulation (EEC) No 2772/75 (15) shall apply. The following definitions shall also apply:
1. egg products: products obtained from eggs, their various components or mixtures thereof, after removal of the shell and membranes, intended for human consumption; they may be partially supplemented by other foodstuffs or additives; they may be liquid, concentrated, dried, crystallized, frozen, quick-frozen or coagulated;
(16) OJ No L 282, 1. 11. 1975, p. 56.
2. farm of production: without prejudice to Regulation (EEC) No 2782/75 (17), farm for the production of eggs intended for human consumption;
3. establishment: establishment approved for the manufacture and/or treatment of egg products;
4. cracked eggs: eggs with a damaged but unbroken shell, with intact membranes;
5. batch: a quantity of egg products which have been prepared under the same conditions and in particular treated in a single continuous operation:
6. consignment: a quantity of egg products for a single delivery to one destination for further processing by the food industry or intended for direct human consumption;
7. country of dispatch: the Member State or third country from which egg products are dispatched to another Member State;
8. country of destination: the Member State to which egg products are dispatched from another Member State or from a third country;
9. packing: the placing of egg products in any form of package;
10. competent authority: the veterinary department or any other equivalent department designated by the Member State concerned to monitor compliance with the provisions of this Directive;
11. placing on the market: the marketing of egg products, as defined in point 5 of Article 1 of Regulation (EEC) No 2772/75.
Article 3 Member States shall ensure that only egg products which meet the following general requirements are produced as foodstuffs or used in the manufacture of foodstuffs:
(a) they must have been obtained from hens', ducks', geese's, turkeys's, guinea fowl's or quail's eggs, but not a mixture of eggs of different species;
(b)
they must bear an indication of the percentage of egg ingredients they contain when they are partially supplemented by other foodstuffs or, provided they fulfil the requirements of Article 12, by additives;
(c)
they must have been treated and prepared in an establishment approved in accordance with Article 6 which complies with Chapters I and II of the Annex, and satisfy the requirements of this Directive;
(d)
they must have been prepared under hygiene conditions complying with Chapters III and V of the Annex, from
(18) OJ No L 282, 1. 11. 1975, p. 100.
eggs meeting the requirements laid down in Chapter IV of the Annex;
(e)
they must have undergone a treatment process authorized under the procedure laid down in Article 14 which enables them to meet inter alia the analytical specifications laid down in Chapter VI of the Annex.
However, where it is necessary for technological reasons associated with the preparation of certain foodstuffs obtained from egg products, the competent authority shall decide, on the basis of criteria to be determined in accordance with the procedure laid down in Article 14, that certain egg products need not undergo treatment; in such a case, the egg products must be used without delay in the establishment where they are intended for the manufacture of other foodstuffs;
(f)
they must comply with the analytical specifications set out in Chapter VI of the Annex;
(g)
they must have undergone a health check in accordance with Chapter VII of the Annex;
(h)
they must have been packed in accordance with Chapter VIII of the Annex;
(i)
they must be stored and transported in accordance with Chapters IX and X of the Annex;
(j)
they must bear the mark of wholesomeness provided for in Chapter XI of the Annex and, where intended for direct human consumption, must meet the requirements of Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (19), as last amended by Directive 86/197/EEC (20).
Article 4 The competent authorities shall ensure that the manufacturers of egg products adopt all measures necessary to comply with this Directive, and in particular that:
- samples for laboratory examination are taken in order to check that the analytical specifications set out in Chapter VI of the Annex have been observed,
- egg products that may not be kept at the ambient temperature are transported or stored at the temperatures stipulated in Chapters IX and X of the Annex,
- the period during which the conservation of egg products is assured is laid down,
- the results of the various checks and tests are recorded and kept for presentation to them for a period of two years,
- each batch marked in such a way that its date of treatment can be identified; this batch mark must appear on the
(21) OJ No L 33, 8. 2. 1979, p. 1.
(22) OJ No L 144, 29. 5. 1986, p. 38.
treatment record and on the mark of wholesomeness provided for in Chapter XI.
Article 5 1. Member States shall ensure that checks are effected to detect any residues of substances having a pharmacological or hormonal action, and of antibiotics, pesticides, detergents and other substances which are harmful or which might alter the organoleptic characteristics of egg products or make their consumption dangerous or harmful to human health.
2. If the egg products examined show traces of residues in excess of the permitted levels fixed in accordance with paragraph 4, they must not be allowed to be used in food
for human consumption or placed on the market, either for
the manufacture of foodstuffs or for direct human consumption.
3. Tests for residues must be carried out in accordance with proven and scientifically recognized methods, in particular those prescribed in Community Directives or other international standards.
It must be possible to assess the tests for residues using reference methods laid down in accordance with the procedure set out in Article 14 after the Scientific Veterinary Committee has expressed its opinion.
In accordance with the same procedure, at least one reference laboratory must be designated in each Member State to carry out the examination for residues in the event of application of Articles 7 and 8.
The Commission shall publish the reference methods and the list of reference laboratories in the Official Journal of the European Communities.
4. Acting by a qualified majority on a proposal from the Commission, the Council shall adopt:
- the detailed arrangements for monitoring,
- the tolerances for the substances referred to in paragraph 2,
- the frequency of sampling.
Article 6 1. Member States shall draw up lists of their approved establishments, each of which shall have an approval number. Member States shall forward this list to the other Member States and to the Commission.
No Member State shall approve an establishment unless compliance with this Directive is assured. A Member State shall withdraw approval if the conditions for granting it cease
to be fulfilled. The other Member States and the Commission shall be informed of the withdrawal of approval.
2. The inspection and monitoring of establishments and packaging centres shall be carried out regularly on the responsibility of the competent authority, which shall at all times have free access to all parts of the establishments, in order to ensure that this Directive is being observed.
If such inspections reveal that not all the requirements of this Directive are being met, the competent authority shall take the appropriate action to remedy the situation.
Article 7 1. Experts from the Commission may, in cooperaton with the competent authorities, make on-the-spot checks insofar as that is indispensable for ensuring uniform application of the Directive; they may in particular verify whether establishments and packing centres approved in accordance with Article 5 (3) of Regulation (EEC) No 2772/75 are actually complying with the Directive.
A Member State within the territory of which a check is being carried out shall give all necessary assistance to the experts in carrying out their duties. The Commission shall inform the Member State concerned of the results of the checks.
The Member State concerned shall take any measures required to take account of the results of the check. If the Member State does not take those measures, the Commission may, in accordance with the procedure laid down in Article 13, decide that the Member State in question must suspend the placing on the market of egg products from the establishment which fails to comply with this Directive.
2. Before the checks referred to in paragraph 1 are carried out, in accordance with the procedure laid down in Article 14, the general provisions for applying this Article shall be determined and a Commission recommendation shall be established, containing the rules to be followed for the purpose of the checks provided for in paragraph 1.
Article 8 1. Without prejudice to Articles 6 and 7, the country of destination may, where there are serious grounds for suspecting irregularities, carry out non-discriminatory inspections of egg products in order to check that a consignment meets the requirements of this Directive.
2. The inspections referred to in paragraph 1 shall be carried out at the place of destination of the goods or at another suitable place, provided that in the latter case the choice of the place interferes as little as possible with the routing of the goods.
Such inspections must be carried out as soon as possible so as not unduly to delay the placing of egg products on the
market, or cause delays which might impair their quality.
3. If, during an inspection carried out in accordance with paragraphs 1 and 2, it is found that the egg products do not comply with this Directive, the competent authority of the country of destination may give the consignor, the consignee or their representative the choice of withdrawing the consignment from the market in order that it may undergo further treatment or of using it for other purposes if this is permissible on health grounds. If not, the alternative offered must be the destruction of the egg products. In any event, precautionary measures shall be taken by the competent authority to prevent improper use of such egg products.
4. (a) Decisions and the grounds for taking them must be notified to the consignor, the consignee or their representative. Should such person so request, reasons must be given for such decisions and must be notified to him immediately in writing together with particulars of the remedies available to him under the law, their forms and the time limits within which action must be taken.
Remedies available to the consignor, the consignee or their representative shall not be affected by this Directive.
(b) If such decisions are based on the existence of a particularly serious risk to human health, they shall be communicated forthwith to the competent authority of the Member State of dispatch and to the Commission.
(c) Following such communication, appropriate measures may be taken in accordance with the procedure laid down in Article 13, in particular for the purpose of coordinating the measures taken in other Member States with regard to the egg products concerned.
5. Member States shall grant consignors whose egg products may not be placed on the market as a result of an inspection as provided for in paragraph 1 the right to obtain an expert's opinion.
The expert must be a national of a Member State other than the country of dispatch or the country of destination.
The Commission, acting on a proposal from the Member States, shall draw up a list of experts who may be instructed to prepare such opinions. The detailed rules for the application of this paragraph shall be adopted according to the procedure laid down in Article 14.
Article 9 Where a Member State considers, after carrying out an inspection in accordance with Article 8, that the provisions of
this Directive are no longer being observed in an establishment in another Member State it shall so inform the competent authority of that State. The said authority shall take all necessary measures and notify the competent authority of the first Member State of the decisions taken and of the reasons for such decisions.
If the first Member State fears that such measures have not been taken or are inadequate, the two Member States shall together seek ways and means of remedying the situation, if necessary by means of an inspection visit of the establishment.
The Member States shall inform the Commission of disputes and of the solutions reached.
If the Member States are unable to reach agreement, one of them shall refer the matter within a reasonable period to the Commission, which shall instruct one or more experts to deliver an opinion.
Pending that opinion, the Member State of dispatch shall intensify checks on egg products coming from the establishment in question and, at the request of the Member State of destination, the Commission shall immediately instruct an expert to go to the consignor establishment in order to propose appropriate interim protective measures.
In the light of the opinion provided for in the fourth subparagraph, or the result of the check performed in accordance with Article 7 (1), Member States may be authorized, under the procedure laid down in Article 13, temporarily to deny access to their territory for egg products coming from that establishment.
Such authorization may be withdrawn under the procedure laid down in Article 13 on the basis of a further opinion delivered by one or more experts.
The experts shall be nationals of a Member State other than those involved in the dispute.
Detailed rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 14.
Article 10 The Annex to this Directive shall be amended by the Council acting by a qualified majority on a proposal from the Commission.
Article 11 1. Pending the application of the provisions of this Directive, national provisions governing imports of egg products from third countries shall continue to apply and must not be more favourable than those governing intra-Community trade.
2. On-the-spot inspections shall be carried out by experts from the Member States and the Commission. Member
States' experts instructed to carry out these inspections shall be appointed by the Commission on proposals from the Member States. Inspections shall be carried out on behalf of the Community, which shall bear the costs relating thereto.
3. A list of the establishments which meet the requirements set out in the Annex shall be drawn up in accordance with the procedure laid down in Article 14.
4. The health certificate accompanying the products on importation and the form and nature of the mark of wholesomeness applied to the products shall correspond to a model to be determined in accordance with the procedure laid down in Article 14.
Article 12 The Council, acting by a qualified majority on a proposal from the Commission, shall decide which additives contained in the list of additives authorized by the Community rules in force on additives which may be used in foodstuffs may be used for the egg products defined in Article 3 (a) and the detailed rules on such use.
Pending such decision, national rules governing such use shall continue to apply.
Article 13 1. Where the procedure laid down in this Article is to be applied, the matter shall be referred forthwith to the Standing Veterinary Committee set up by the Council Decision of 15 October 1968 (hereinafter referred to as ´the committee') by its chairman on his initiative or at the request of a Member State.
2. The respresentative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
4. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within 15 days of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 14 1. Where the procedure laid down in this Article is to be applied, the chairman shall refer the matter without delay to the committee on his own initiative or at the request of a Member State.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the
case of decisions which the Council is required to adopt
on a proposal from the Commission. The votes of the representatives of the Member State within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.
3. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee.
4. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.
If, within three months of the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple majority.
Article 15 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1991. They shall inform the Commission thereof forthwith.
The Commission shall, no later than 31 December 1994, submit a report to the Council on the experience acquired on the subject, accompanied, where appropriate, by proposals aimed at adapting the Annex to this Directive taking special account of scientific and technological developments.
Article 16 This Directive is addressed to the Member States.
Done at Luxembourg, 20 June 1989.