REPORT on the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption
(COM(2000) 438 – C5‑0382/2000 – 2000/181(CNS))

7 December 2001 - *

Committee on Agriculture and Rural Development
Rapporteur: Heinz Kindermann

PROCEDURAL PAGE

By letter of 24 July 2000 the Council consulted Parliament, pursuant to Article 37 of the EC Treaty, on the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption (COM(2000) 438 – 2000/181(CNS)).

At the sitting of 17 November 2000 the President of Parliament announced that she had referred this proposal to the Committee on Agriculture and Rural Development as the committee responsible and the Committee on the Environment, Public Health and Consumer Policy for its opinion (C5-0382/2000).

At the sitting of 4 September 2000 the President of Parliament announced that she had also referred the proposal to the Committee on Industry, External Trade, Research and Energy and the Committee on Fisheries for their opinions.

The Committee on Agriculture and Rural Development appointed Heinz Kindermann rapporteur at its meeting of 13 September 2000.

At its meeting of 18 September 2001 it decided, pursuant to Rule 63(2) to request the opinion of the Committee on Legal Affairs and the Internal Market on the legal basis of the proposal.

The Committee on Agriculture and Rural Development considered the Commission proposal and draft report at its meetings of 10 October 200, 24 January 2001, 18 September 2001 and 3 December 2001.

At the last meeting it adopted the draft legislative resolution unanimously.

The following were present for the vote: Friedrich-Wilhelm Graefe zu Baringdorf, chairman; Joseph Daul, vice-chairman; Heinz Kindermann, rapporteur; Gordon J. Adam, Danielle Auroi, María del Pilar Ayuso González (for Elisabeth Jeggle), Carlos Bautista Ojeda, Giorgio Celli, Arlindo Cunha, Michel J.M. Dary, Avril Doyle (for Robert William Sturdy), Christel Fiebiger, Francesco Fiori, Carmen Fraga Estévez (for Michl Ebner), Georges Garot, Lutz Goepel, Willi Görlach, María Izquierdo Rojo, Dimitrios Koulourianos, Wolfgang Kreissl-Dörfler (for Bernard Poignant), Albert Jan Maat, Xaver Mayer, Neil Parish, Mikko Pesälä, Agnes Schierhuber and Struan Stevenson.

The opinions of the Committee on Industry, External Trade, Research and Energy, the Committee on the Environment, Public Health and Consumer Policy, the Committee on Fisheries and the Committee on Legal Affairs and the Internal Market are attached.

The report was tabled on 7 December 2001.

The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session.

LEGISLATIVE PROPOSAL

Proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption (COM(2000) 438 – C5‑0382/2000 – 2000/181(CNS))

The proposal is amended as follows:

Text proposed by the Commission[1]	Amendments by Parliament
Amendment 1 Recital 9
(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include an evaluation of the animal health situation in the third countries concerned.	(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include a regular evaluation of the animal health situation in the third countries concerned.
Justification Evaluation of the animal health situation in third countries cannot be a static element in view of the rapid spread of certain epizootic diseases.
Amendment 2 Recital 15
(15)   Provision must be made for the organisation of Community audits and inspections in order to ensure the uniform application of the animal health provisions.	(15)   Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions.
Justification Self-explanatory.
Amendment 3 Article 2
For the purposes of this Regulation, the definitions laid down in the Directives referred to in Annex I and, where applicable, in Council Regulation …/… on the hygiene of foodstuffs, shall apply.	For the purposes of this Regulation, the definitions laid down in the Directives referred to in Annex I and, where applicable, in Council Regulations…/… on the hygiene of foodstuffs and in the specific hygiene legislation applicable to products of animal origin for human consumption shall apply.
Justification This amendment is designed to combine all the relevant legal bases. It is already evident that definitions are already incorporated in the specific hygiene legislation.
Amendment 4 Article 3, paragraph 2, point (aa) (new)
	(aa)   which are in accordance with the measures taken by the Council of Agriculture Ministers of 4 December 2000 to ban cattle aged over 30 months which have not been tested for BSE from entering the food chain;
Justification: In view of recent developments in the area of BSE, it is necessary to refer to these and to update the proposal for a regulation.
Amendment 5 Article 3, paragraph 2, point (c) (new)
	(c)   which have been documented and recorded as part of traceability procedures that facilitate the removal of such animals from the food chain if they pose a risk to human health.
Justification The introduction of adequate traceability procedures for all animal food products is a major aim of the Commission’s proposals to revamp EU food hygiene rules. It is important to insert the necessity for adequate traceability procedures to be in place, especially as Article 3(3) provides for animals not coming from a holding which is infected in a territory or part of territory subject to animal health restrictions to enter the food chain. As the FMD crisis has demonstrated, it is imperative to have adequate traceability procedures in place in order to avoid the possibility that infected animals will incorrectly enter the human food chain.
Amendment 1 Article 3, paragraph 4
4.   Derogations from paragraph 2 may be granted in specific situations, in accordance with the procedure referred to in Article 11. In such cases, particular account shall be taken of:	4.   Where the disease situation so permits, derogations from paragraph 2 may be granted in specific situations for definite periods of time corresponding to developments in the health status of the territory or portion of territory and reviewable at any time, in accordance with the procedure referred to in Article 11. In such cases, particular account shall be taken of:
(a)   any measure or test to be carried out on the animals;	(a)   any measure or test to be carried out on the animals;
(b)   the specific characteristics of the disease in the species concerned.	(b)   the specific characteristics of the disease in the species concerned.
Where such derogations are granted, any measures needed to ensure the protection of animal health in the Community shall be adopted in accordance with the same procedure.	Where such derogations are granted, it shall be guaranteed that the degree of protection from animal disease will in no way be impaired. Any measures needed to ensure the protection of animal health in the Community shall therefore be adopted in accordance with the same procedure.
Justification The Regulation must specify under what circumstances derogations will be allowed, that is to say, that they may be granted only when the disease situation so permits. In addition, safeguards will need to be put in place to prevent such derogations from in any way impairing the degree of protection from animal disease.
Amendment 7 Article 4
Official controls shall be carried out by the competent authorities of the Member States to ensure compliance with this Regulation, its implementing rules and any safeguard measures applied to products of animal origin, pursuant hereto.	Unannounced official controls shall be carried out at irregular intervals by the competent authorities of the Member States to ensure compliance with this Regulation, its implementing rules and any safeguard measures applied to products of animal origin, pursuant hereto.
	Member States shall, where so requested, submit a report to the Commission on the controls carried out, specifying in particular the frequency of controls, the nature of the failings and infringements found to exist, and the nature of the steps taken by the competent authorities to punish them.
Detailed rules on these controls, their results and the decisions to be taken on the basis of those results shall be adopted in accordance with the procedure referred to in Article 11.	Detailed rules on these controls, their results and the decisions to be taken on the basis of those results shall be adopted in accordance with the procedure referred to in Article 11.
Justification Given that more detailed rules on controls will be adopted under the commitology procedure, certain basic principles to govern their conduct need to be spelt out beforehand, in other words in the proposed regulation. Member States must carry out their controls at irregular intervals without prior warning. If it thinks it necessary, the Commission must receive reports specifying the extent of the controls carried out by the Member States, the findings of those controls, and the penalties imposed as a result. In the light of that information it will be able to propose such amendments as might be required to the Regulation.
Amendment 8 Article 5, paragraph 3
Infringements of this Regulation, its implementing rules or any safeguard health measures applied to products of animal origin, as well as any failure to cooperate with the competent authority shall result in the imposition of the appropriate criminal and/or administrative penalties by the competent national authorities.	Infringements of this Regulation, its implementing rules or any safeguard health measures applied to products of animal origin, as well as any failure to cooperate with the competent authority shall result in the imposition of the appropriate criminal and/or administrative penalties by the competent national authorities. The public may be informed about the persons involved and the nature of these infringements by the competent authorities and food agencies of the Member States, in order to foster best hygiene practice throughout the EU.
Justification The recent example of the Food Safety Authority of Ireland posting the names and addresses of those persons who have had a food premises closed points to the usefulness of such a procedure to foster good hygiene practice. It also assists in creating a degree of transparency with regard to such matters, which will assist in enhancing consumer confidence in the food safety procedures in place that regulate the entry of animals into the food chain.
Amendment 9 Article 5, paragraph 3 a (new)
	The Commission shall draw up a list of categories of possible infringements of this Regulation, its implementing rules, or safeguard measures and shall determine in each instance whether the infringements are punishable by the competent national authorities under criminal or administrative law.
Justification To enable the Regulation to be enforced in the Member States in the same way, penalties must be standardised. The provisions laid down at Community level should serve at least to establish what kind of infringements are punishable under criminal law and what kind under administrative law, as there will otherwise be a danger that competition might be distorted if the severity of penalties varied from one Member State to the next. A classification of penalties on the basis described above could remedy this problem.
Amendment 10 Article 6, paragraph 1
1.   Experts from the Commission may, in cooperation with the competent authorities of the Member States, make audits and/or inspections at all stages in the production and marketing of products of animal origin as well on the organisation and functioning of the competent authorities in the Member States, in order to ensure the uniform application of this Regulation, its implementing rules and any safeguard measures pursuant hereto. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection.	1.   Experts from the Commission may, in cooperation with the competent authorities of the Member States, make audits and/or inspections at all stages in the production and marketing of products of animal origin as well as on the organisation and functioning of the competent authorities in the Member States, in order to ensure the uniform application of this Regulation, its implementing rules and any safeguard measures pursuant hereto. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection. The Commission will be permitted to publicise the fact that a Member State is refusing to permit Commission experts to make audits and/or inspections and if necessary impose further actions against the Member State concerned as may be determined by the procedures referred to in Article 11.
Justification A speedy response to a potential food alert is essential. During the dioxin crisis the Belgian authorities refused for a number of weeks to permit Commission officials from the Food and Veterinary Office to make any inspections on their territory. This amendment will prevent such a situation occurring in the future, by publicising a Member State’s refusal to allow Commission officials to enter its territory and giving the Standing Veterinary Committee the power to introduce other measures as it sees fit.
Amendment 11 Article 6, paragraph 4
4.   To enable audits and/or inspections to be carried out efficiently, the Member State in whose territory an audit and/or inspection is undertaken shall give all necessary assistance and provide all documentation requested by the Commission experts for the purpose of the audit.	4.   Commission experts may, in so far as this is necessary for the uniform implementation of this Regulation, carry out on-the-spot checks in collaboration with the competent authorities of the Member States. The Member State on whose territory a check is carried out shall give all necessary assistance to the experts in the performance of their duties. The Commission shall inform the competent authorities, the Member States, and the European Parliament of the result of the checks carried out.
Justification For the purpose of giving proper effect to this key regulation in the prevention of epizootic diseases, it is essential that in parallel with the audits, surprise inspections may be carried out. As regards the assistance of the competent national authorities, it is helpful to reuse the terms of Parliament's legislative resolution on the common position of the Council with a view to the adoption of Directive 2001/…/EC of the European Parliament and of the Council of … amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC, and 1999/29/EC on animal nutrition (13724/1/2000 – C5‑0047/2001 – 2000/0068(COD)).
(Amendment 12) Article 7
The provisions applicable to the importation of products of animal origin from third countries shall comply with or be equivalent to those applicable to the production and marketing of Community products.	The provisions applicable to the importation of products of animal origin from third countries shall comply with or be equivalent to those applicable to the production and marketing of Community products. Where these rules are stricter than those laid down by the ‘Office International des Epizooties’ (OIE), specific provisions must make it possible to take account of the extent to which developing countries that export, or which are potential exporters, into the European Union are able to comply with such rules, as far as possible, without endangering the objective of a high level of animal and human health protection.
Justification The use of rules that are different from those laid down at international level can create obstacles to trade and problems for developing countries in particular, which are heavily dependent on export markets.
Amendment 13 Article 8, paragraph 1, subparagraph 2, indent 2
–   the organisation of the competent authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and their authority to monitor effectively the application of their legislation,	–   the organisation of the competent authority and its inspection services in the third country, the powers of these services, the supervision to which they are subject, and their authority and the staff complement required to monitor effectively the application of their legislation,
Justification Lists of third countries are to be compiled in the light of various criteria, including the effectiveness of the inspections carried out by third-country inspection services. The key point in this instance, however, is not just the powers and authority of those services, but also, and above all, the fact that they have the staff needed to exercise their powers. Given that the lists are to be drawn up under the regulatory committee procedure, the criteria must be set out clearly and in full.
Amendment 14 Article 8, paragraph 1, subparagraph 2, indent 6
–   the results of Community inspections in the third country,	–   the results of Community inspections in the third country or, where the Commission so requests, the report submitted by the competent authorities of the third country on the inspections which they have carried out,
Justification Like the Member States (cf. Amendment 2), third countries should, where so requested, submit a report to the Commission on the inspections carried out. The information in such reports could provide a valuable complement to the inspections conducted by the European veterinary authority, which, because of staff shortages, still do not take place as frequently as required.
Amendment 15 Article 8, paragraph 1, subparagraph 2, indent 8
–   the regularity and speed with which the third country supplies information about the existence of infectious or contagious animal diseases in its territory, in particular the diseases mentioned in Lists A and B of the International Office of Epizootic Diseases (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases as listed in the Aquatic Animal Health Code of the OIE,	–   the regularity and speed with which the third country supplies information, and the accuracy of that information, about the existence of infectious or contagious animal diseases in its territory, in particular the diseases mentioned in Lists A and B of the International Office of Epizootic Diseases (OIE) or, in the case of diseases of aquaculture animals, the notifiable diseases as listed in the Aquatic Animal Health Code of the OIE,
Justification Lists of third countries are to be compiled in the light of various criteria, including the regularity and speed with which third-country authorities supply information on animal disease status. What matters above all, however, is that the information in question is accurate. Given that the lists are to be drawn up under the regulatory committee procedure, the criteria must be set out clearly and in full.
Amendment 16 Article 9
1.   Audits and/or inspections at all stages covered by this Regulation may be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal health rules. Commission experts may be accompanied by any other expert appointed by the Commission for the purposes of the audit and/or inspection.	1.   Audits and/or inspections at all stages covered by this Regulation must be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal health rules. Commission experts may be accompanied by any other expert appointed by the Commission for the purposes of the audit and/or inspection.
2.   The audits and/or inspections in third countries referred to in paragraph 1 shall be carried out on behalf of the Commission and the latter shall meet the costs incurred.	2.   The audits and/or inspections in third countries referred to in paragraph 1 shall be carried out on behalf of the Commission and the latter shall meet the costs incurred.
3.   The procedure for the audits and/or inspections in third countries referred to in paragraph 1 may be determined or amended in accordance with the procedure referred to in Article 11.	3.   The procedure for the audits and/or inspections in third countries referred to in paragraph 1 may be determined or amended in accordance with the procedure referred to in Article 11.
4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof.	4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof by means of the early warning system.
Justification Self-explanatory.
Amendment 17 Annex II, paragraph 2, subparagraph 2
The mark must be applied by or under the responsibility of the official veterinarian responsible for controlling the implementation of the animal health requirements.	The mark must be applied by the official veterinarian responsible for controlling the implementation of the animal health requirements.
Justification In parallel with the systematisation of the HACCP principle, the presence of veterinarians and their official activities must be maintained for the proper implementation of health principles and the enhancement of food safety.

• [1] OJ C 365 E, 19.12.2000, p. 132.

DRAFT LEGISLATIVE RESOLUTION

European Parliament legislative resolution on the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption (COM(2000) 438 – C5‑0382/2000 – 2000/181(CNS))

(Consultation procedure)

The European Parliament,

–   having regard to the Commission proposal to the Council (COM(2000) 438[1]),

–   having been consulted by the Council pursuant to Article 37 of the EC Treaty (C5‑0382/2000),

–   having regard to the opinion of the Committee on Legal Affairs and the Internal Market on the proposed legal basis,

–   having regard to Rule 67 of its Rules of Procedure,

–   having regard to the report of the Committee on Agriculture and Rural Development and the opinions of the Committee on Industry, External Trade, Research and Energy, the Committee on the Environment, Public Health and Consumer Policy, and the Committee on Fisheries (A5‑0452/2001),

1.   Approves the Commission proposal as amended;

2.   Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

3.   Calls on the Council to notify Parliament should it intend to depart from the text approved by Parliament;

4.   Calls for the conciliation procedure to be initiated should the Council intend to depart from the text approved by Parliament;

5.   Asks to be consulted again if the Council intends to amend the Commission proposal substantially;

6.   Instructs its President to forward its position to the Council and Commission.

• [1] OJ C 365 E, 19.12.2000, p. 132.

EXPLANATORY STATEMENT

INTRODUCTION

Products of animal origin can be infected with pathogens and pose a serious risk of infection to any live animals with which they may come into contact. Even though there may be no direct danger to human health, this situation can still entail considerable economic losses for the farms concerned.

The specific hygiene rules for intra-Community trade in products of animal origin and imports from third countries are at present laid down in seven different Directives. The purpose of the rules is to prevent animal diseases from spreading when the above products are placed on the market.

The fact that some provisions are common to all of the Directives in force and the Directives to some extent overlap does little to help the clarity of the legislation.

AIM OF THE PROPOSAL

The proposal for a regulation under consideration is intended to make the animal-health rules more transparent and encompass the existing Directives within a single text. A regulation has deliberately been chosen as the legal instrument so as to ensure that the rules will in future be enforced in the same way in the EU as a whole and in third countries.

CONTENT OF THE PROPOSAL

The proposal consists of three chapters and three annexes.

Chapter I deals with the animal health requirements for the production and marketing of Community products. Article 3 specifies under what circumstances products of animal origin may be marketed (the animals must come from an area not subject to restrictions, or, if they do come from an area subject to restrictions, the prescribed treatment must have been applied to destroy any pathogens). Rules are also laid down to govern official controls by Member States (Article 4), penalties for infringements of the rules (Article 5), and Community audits and inspections (Article 6).

Chapter II is given over to imports from third countries and, in particular, lays down the principle that products of animal origin imported from third countries must conform to the rules applying in the Community or rules of an equivalent standard. To guarantee that this will be the case, lists based on a range of data are to be drawn up to identify those third countries from which products of animal origin may be imported, and special import conditions will be enforced, depending on the health situation in each specific instance.

The Commission, acting on behalf of the Community, may conduct audits and inspections in third countries in order to ascertain whether Community rules are being observed or the third-country rules are of an equivalent standard.

Chapter III contains the final provisions and, most importantly, lays down the commitology procedure. The Commission is planning to use the regulatory procedure because the measures required to implement the Regulation will be of general scope, as referred to in Article 2 of the commitology Decision (1999/468/EC). Responsibility for matters arising under the procedure will lie in every case with the Standing Veterinary Committee.

A further stipulation of this chapter states that the Regulation will apply from 2004.

Annex I lists the animal diseases control of which is already regulated under Community legislation, along with the Directives concerned and the measures to be employed to control African swine fever until specific rules have been laid down at Community level.

Annex II specifies the form of identification of fresh meat originating from an area affected by a disease that has to be treated in order to destroy any pathogens.

Finally, Annex III lays down the treatment methods to destroy pathogens.

ASSESSMENT OF THE PROPOSAL

The rapporteur welcomes the Commission’s intention to bring together and simplify the complex legislation. He particularly applauds the fact that the rules will be combined in the form of a regulation, since he believes this to be the only means of ensuring that they can be enforced uniformly in all parts of Europe and the control of animal diseases is one area in greatest need of such an approach.

However, the effectiveness of the legal framework will depend to a large extent on the checks carried out. The rapporteur accordingly welcomes the Commission’s announcement that it will be submitting a proposal for a horizontal regulation governing official controls in the food and veterinary sector as a whole. That notwithstanding, the text of the regulation now being proposed should already specify at this stage that Member States must carry out official controls without prior warning. Furthermore, if the Commission thinks it necessary, it must be entitled to request detailed reports from the Member States on their controls so that it can learn how the Regulation is being implemented and hence identify possible weak spots. The rapporteur also wishes, however, to raise the crucial question whether the present staff complement of the Dublin-based European Food and Veterinary Office is sufficient to conduct the necessary Community inspections in Member States and third countries and thus monitor enforcement of the existing rules in the proper fashion.

Arrangements which have to date been implemented to good effect in the Member States should be incorporated unchanged in the new instrument resulting from the proposed reorganisation. As a matter of principle, all measures to be implemented under the Regulation must have a sound scientific basis.

Furthermore, it must be ensured that the applicant countries become involved at the current stage, in other words while the legislation is being recast, so as to enable them, once they have joined, to enforce the provisions applying at that time.

The penalties for infringements of the Regulation need to be standardised as closely as possible for all the Member States. It is unacceptable for a given form of misconduct to be treated as a breach of administrative regulations in one Member State and as an act constituting a criminal offence in another. The Commission should therefore list the different categories of possible infringements and stipulate in each instance whether they are to be punishable by the competent national authorities under administrative or criminal law.

The derogations provided for in the Regulation must in general be of limited scope and exactly defined in every case.

Looking at the Regulation as a whole, the Commission is relying extensively on the procedure referred to in Article 11, that is to say the regulatory commitology procedure, which will be used not only to amend the three annexes (Article 10), but also to grant derogations (Article 3(4)), lay down the detailed rules on official controls to be observed by the Member States (Article 4) and the arrangements for the Community inspections to be carried out both within the Community (Article 6) and in third countries (Article 9), and, for the purposes of Article 8, to draw up the list of third countries from which specified products of animal origin may be imported and determine the criteria for ascertaining the disease status of a third country. Especially where disease control is concerned, the Commission must and should be able to react more quickly and effectively to new scientific knowledge and unforeseen circumstances without being obliged on every occasion to embark on a protracted legislative procedure. That is why certain technical matters will have to be dealt with by the commitology procedure. The rapporteur notes, however, that the Commission is tending to encompass more and more areas within the scope of the commitology procedure, in which Parliament plays no role whatsoever, and therefore believes that the instrument proper must establish the framework to be subsequently fleshed out, in this case under the regulatory procedure. Some parts of the Regulation consequently need to be enlarged upon.

Article 2 refers to the validity of definitions from other instruments, especially the Directives listed in Annex I and the future regulation on the hygiene of foodstuffs (2000/0178(COD)). One point to make in this connection is that the present definitions are inconsistent, especially as regards the proposal for a regulation laying down the general principles and requirements of food law (COM(2000) 716). It is absolutely essential to bring these definitions into line, as the regulations might otherwise become very difficult to enforce.

CONCLUSIONS

On the whole, the proposal dealt with in this report is a good one. However, the text of the Regulation must be made more explicit on the questions of controls and inspections, penalties, and derogations, the details of which are to be worked out more exactly under the regulatory committee procedure. The amendments on these subjects tabled in the report are intended to establish a narrower framework for the Commission, thus ensuring that the commitology procedure will be implemented more transparently. The criteria to be taken into account when drawing up lists of third countries need in some respects to be clarified.

OPINION OF THE COMMITTEE ON LEGAL AFFAIRS AND THE INTERNAL MARKET

Mr Friedrich-Wilhelm Graefe zu Baringdorf

Chairman

Committee on Agriculture and Rural Development

BRUSSELS

Subject:   Legal basis of the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption.

(COM(2000) 438 - 2000/0181(CNS))

Dear Mr Chairman,

On October 21 2001, your committee forwarded a formal request to examine the legal basis of the Commission's proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption.

The Committee on Legal Affairs and the Internal Market considered your request pursuant to Rule 63 at its meeting on 10-11 October 2001.

The Commission's proposal is a part of a package of proposals resulting from a recasting of Community legislation on food hygiene, animal health and official controls on products of animal origin. The general aim of this package of proposals is to ensure a high level of health protection in the above-mentioned areas. Existing legislation is to be repealed.

As the Commission states in its explanatory memorandum, animal health rules are designed to prevent the spread of animal diseases such as swine fever and foot-and-mouth disease through products of animal origin.

The Commission's proposal is based on article 37 EC.

According to its Article 1, the proposal for a Regulation aims at laying down "the animal health rules governing the placing on the market of products of animal origin and imports from third countries".

For this purpose, the proposal sets out in Chapter I requirements for the production and marketing of Community products, such as rules on marketing, on official controls, on Community audits and inspections.

Article 6 of the proposal provides that experts from the Commission may "make audits and/or inspections at all stages in the production and marketing of products of animal origin as well as on the organisation and functioning of the competent authorities in the Member States, in order to ensure the uniform application of the proposed regulation, its implementing rules and any safeguard measures pursuant [t]hereto". Experts should have "adequate training in food hygiene and safety, auditing techniques (...)" (emphasis added).

Chapter II, concerning imports from third countries, provides that the provisions applicable to imports shall comply with or be equivalent to those applicable to the production and marketing of Community products.

For this purpose, Article 8 of the proposal provides for establishing a list of the third countries or parts of third countries from which imports of specified products of animal origin are permitted. Indent 7 of Article 8(1) mentions that, when establishing these lists, particular account shall be taken of "the health status of the livestock, other domestic animals and wildlife in the third country, having particular regard to exotic animal diseases and any aspects of the general health situation in the country, which might pose a risk to public or animal health in the Community" (emphasis added).

Indent 7 of Article 8(1) is the only reference to public health in this proposal.

It is clear from settled case law of the ECJ that the choice of the legal basis does not depend on the discretion of the Community legislature but must be based on objective elements which are amenable to judicial control. Among these elements are, in particular, the aim and the content of the legal act[1]. In practice, the Court bases its findings essentially on the recitals stated in the preamble.

It is also necessary to determine whether the measures in question relate principally to a particular field of action, having only incidental effects on other policies, or whether both aspects are equally essential.

If the first hypothesis is correct, recourse to a single legal basis is sufficient[2]; if the second is correct, it is insufficient[3] and the institution is required to adopt the measure on the basis of both of the provisions from which its competence derives.[4] However, no such dual basis is possible where the procedures laid down for each legal basis are incompatible with each other.[5]

The Commission proposal is based on Article 37 EC. This provision on agricultural policy must be interpreted in light of Article 32 EC and Annex I (former Annex II) to the EC Treaty. Article 32(1) EC defines "agricultural products" as including the products of the soil, of stockfarming and of fisheries and products of first-stage processing directly related to these products.

The ECJ stated that "article 37 is the appropriate legal basis for any legislation concerning the production and marketing of agricultural products listed in annex I to the Treaty which contributes to the achievement of one or more of the objectives of the common agricultural policy set out in article 33 of the Treaty"[6].

The second legal basis examined by the members of the Committee on Legal Affairs and the Internal Market is Article 152(4)(b) EC. The Court has stated that, according to the third subparagraph of article 152(1) EC, health protection requirements form a constituent part of the Community's other policies and that efforts to attain objectives of the common agricultural policy cannot disregard requirements relating to the public interest such as the protection of consumers or protection of the health and life and humans and animals, requirements which Community institutions must take into account in exercising their powers.[7]

Moreover, the protection of health contributes to the attainment of the objectives of the common agricultural policy which are laid down in Article 33(1) of the Treaty, particularly where agricultural production is directly dependent on demand amongst consumers who are increasingly concerned to protect their health.[8]

In a case concerning identification and registration of bovine animals, the Court held that a regulation laying down the rules on identification and registration of bovine animals and on labelling of beef was rightly adopted on the basis of Article 37 EC.[9]

The ECJ further mentioned that the taking into account of public health in the context of measures adopted on the basis of Article 37 is compatible with the third subparagraph of Article 152(1).[10]

In order to determine the adequate legal base of the Commission's proposal, it is necessary to examine the aim and content of the proposal in the light of the above-mentioned case-law.

The content of the proposed regulation consists of laying down rules on the production, placing on the market and importation of products of animal origin intended for human consumption. The proposed regulation thus concerns the production and marketing of agricultural products listed in Annex I to the Treaty.

As regards the aim of the proposed regulation, it must be observed that, according to the fourth and sixth recitals, it is intended to harmonise existing specific rules which aim to prevent the spread of animal diseases resulting from the placing on the market of products of animal origin.

The eighth recital states that products imported from third countries must not present a animal health hazard for Community livestock.

The ninth recital also states that, to that end, procedures must be introduced to prevent the introduction of epizootic diseases; such procedures including an evaluation of the animal health situation in the third countries concerned.

Finally, the sixteenth recital mentions that the products covered by the proposal are listed in Annex I of the Treaty. The latter consists of a list, referred to in Article 32 EC. This list includes products such as live animals; meat and edible meat offal; fish, crustaceans and molluscs; guts, bladders and stomachs of animals; among other products.

It must therefore be concluded that, in regulating the conditions for the production, placing on the market and importation of products of animal origin intended for human consumption, the proposed regulation is essentially intended to attain the objectives of Article 33 of the Treaty, in particular the stabilisation of the market.

It is true that the seventh indent of Article 8(1) of the regulation at issue includes a particular concern about risks caused by animals to public or animal health in the Community.

However, it can be considered that this is only one condition for the establishment of such lists. The proposed regulation therefore has only the incidental effect of contributing to public health inasmuch as, by means of setting up a list of countries from which imports of specified products of animal origin are permitted, it also concerns the veterinary field.

At its meeting of 11 October 2001, the Committee on Legal Affairs and the Internal Market therefore decided by 6 votes in favour and 4 against that Article 37 EC is the adequate legal basis of the Commission's proposal[11].

Yours sincerely,

(sgd) Ana Palacio Vallelersundi

• [1] See, inter alia, ECJ, case C-42/97, Parliament v Council, para. 36.
• [2] Case C-70/88 Parliament v Council [1991] ECR I-4529, paragraph 17, and Case C-271/94 Parliament v Council [1996] ECR I-1689, paragraphs 32 and 33.
• [3] Case 242/87 Commission v Council [1989] ECR 1425, paragraphs 33 to 37, and Case C-360/93 Parliament v Council [1996] ECR I-1195, paragraph 30.
• [4] Case 165/87 Commission v Council [1988] ECR 5545, paragraphs 6 to 13.
• [5] Case C-300/89 Commission v Council [1991] ECR I-2867, paragraphs 17 to 21.
• [6] ECJ, Case 68/86 United Kingdom v Council [1988] ECR 855 and Case 131/86 United Kingdom v Council [1988] ECR 905.
• [7] Case C-189/96 United Kingdom v Commission, paragraph 120.
• [8] Case C-189/96 United Kingdom v Commission, paragraph 121.
• [9] Case C-269/97, Commission and Parliament v. Council, paragraph 60.
• [10] Case C-269/97, Commission and Parliament v. Council, paragraph 62.
• [11] Present: Ana Palacio Vallelersundi (chairman), Ward Beysen (vice-chairman), Neil MacCormick (draftsman), Paolo Bartolozzi, Klaus-Heiner Lehne, Luís Marinho, Manuel Medina Ortega, Dagmar Roth-Behrendt, Gary Titley, Joachim Wuermeling.

OPINION OF THE COMMITTEE ON INDUSTRY, EXTERNAL TRADE, RESEARCH AND ENERGY

6 November 2001

for the Committee on Agriculture and Rural Development

on the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

(COM(2000) 438 – C5-0382/2000 – 2000/0181(CNS))

Draftsman: Yves Piétrasanta

PROCEDURE

The Committee on Industry, External Trade, Research and Energy appointed Yves Piétrasanta draftsman at its meeting of 13 September 2000.

It considered the draft opinion at its meetings of 18 September and 6 November 2001.

At the latter meeting it adopted the following amendments unanimously.

The following were present for the vote: Carlos Westendorp y Cabeza, chairman; Renato Brunetta and Peter Michael Mombaur, vice-chairmen; Konstantinos Alyssandrakis, Giles Bryan Chichester, Christos Folias, Pat the Cope Gallagher, Norbert Glante, Alfred Gomolka (for Christian Foldberg Rovsing), Michel Hansenne, Malcolm Harbour (for W.G. van Velzen), Roger Helmer, Hans Karlsson, Bashir Khanbhai (for John Purvis), Constanze Angela Krehl (for Mechtild Rothe, pursuant to Rule 153(2)), Werner Langen, Albert Jan Maat (for Konrad K. Schwaiger), Eryl Margaret McNally, Nelly Maes, Erika Mann, Hans-Peter Martin (for Glyn Ford), Angelika Niebler, Barbara O’Toole (for Elena Valenciano Martínez-Orozco), Reino Paasilinna, Elly Plooij-van Gorsel, Samuli Pohjamo (for Astrid Thors), Bernhard Rapkay (for François Zimeray), Imelda Mary Read, Paul Rübig, Ilka Schröder, Esko Olavi Seppänen, Claude Turmes (for Nuala Ahern), Alejo Vidal-Quadras Roca, Dominique Vlasto, Anders Wijkman, Myrsini Zorba and Olga Zrihen Zaari.

AMENDMENTS

The Committee on Industry, External Trade, Research and Energy calls on the Committee on Agriculture and Rural Development, as the committee responsible, to incorporate the following amendments in its report:

Text proposed by the Commission[1]	Amendments by Parliament
(Amendment 1) Recital 9
(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include an evaluation of the animal health situation in the third countries concerned.	(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include an evaluation of the animal health situation in the third countries concerned. Such evaluation must be carried out in a proper manner in order to give an account of the actual health situation in the countries concerned.
Justification The evaluation of the animal health situation in third countries cannot be a static element in view of the rapid spread of certain epizootic diseases.
(Amendment 2) Recital 15
(15)   Provision must be made for the organisation of Community audits and inspections in order to ensure the uniform application of the animal health provisions.	(15)   Community audits and inspections must be organised in order to ensure the uniform application of the animal health provisions.
Justification Self-explanatory.
(Amendment 3) Article 3, paragraph 2, point (a a) (new)
	(aa)   in accordance with the measures taken by the Council of Agriculture Ministers of 4 December 2000 to ban cattle aged over 30 months which have not been tested for BSE from entering the food chain;
Justification In view of recent developments in the area of BSE, it is necessary to refer to these and to update the proposal for a regulation.
(Amendment 4) Article 3, paragraph 4, subparagraph 1
4.   Derogations from paragraph 2 may be granted in specific situations, in accordance with the procedure referred to in Article 11. In such cases, particular account shall be taken of:	4.   Derogations from paragraph 2 may be granted in specific situations, for definite periods of time corresponding to developments in the health status of the territory or portion of territory and reviewable at any time, in accordance with the procedure referred to in Article 11. In such cases, particular account shall be taken of:
Justification The health situation of a territory or part of territory is bound to evolve positively or negatively. Consequently, it is necessary to provide for measures limited in time and reviewable at any time.
(Amendment 5) Article 5, paragraph 2
Where the legal or natural person or persons involved in the infraction fail to remedy the situation within the time fixed by the competent authority, or if a serious animal-health risk is found, restrictions shall be placed on the production and marketing of the products concerned. Such restrictions may entail a ban on the production and marketing of products of animal origin and the withdrawal and, if necessary, destruction of products already placed on the market.	The early warning system must be used to inform the Commission. Where the legal or natural person or persons involved in the infraction fail to remedy the situation within the time fixed by the competent authority, or if a serious animal-health risk is found, restrictions shall be placed on the production and marketing of the products concerned. Such restrictions may entail a ban on the production and marketing of products of animal origin and the withdrawal and destruction of products already placed on the market. Such restrictions must be communicated to the public in appropriate terms.
Justification Since epizootic diseases caused by the placing on the market of contaminant products of animal origin can have direct or indirect consequences for human health, it is desirable that the early-warning system, redefined in the regulation setting up the new food authority, should be deployed in this area.
(Amendment 6) Article 6, paragraph 2
2.   The Commission shall communicate its general programme of audits and/or inspections to the Member States on a regular basis and shall inform them of the results.	2.   The Commission shall communicate its general programme of audits to the Member States on a regular basis and shall inform them of the results. It may at any time carry out surprise inspections in the Member States and inform them of the result.
Justification For the purpose of giving proper effect to this key regulation in the prevention of epizootic diseases, it is essential that in parallel with the audits, surprise inspections may be carried out. As regards the assistance of the competent national authorities, it is helpful to reuse the terms of the legislative resolution of the European Parliament on the common position of the Council with a view to the adoption of Directive 2001/…/EC of the European Parliament and of the Council of … amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition (13724/1/2000 – C5-0047/2001 – 2000/0068(COD)).
(Amendment 7) Article 6, paragraph 4
4.    To enable audits and/or inspections to be carried out efficiently, the Member State in whose territory an audit and/or inspection is undertaken shall give all necessary assistance and provide all documentation requested by the Commission experts for the purpose of the audit.	4.    Commission experts may, in so far as this is necessary for the uniform implementation of the present Regulation, carry out on-the-spot checks in collaboration with the competent authorities of the Member States. The Member State on whose territory a check is carried out shall give all necessary assistance to the experts in the performance of their duties. The Commission shall inform the competent authorities, the Member States and the European Parliament of the result of the checks carried out.
Justification Same justification as for Amendment 6, Article 6, paragraph 2.
(Amendment 8) Article 7
The provisions applicable to the importation of products of animal origin from third countries shall comply with or be equivalent to those applicable to the production and marketing of Community products.	The provisions applicable to the importation of products of animal origin from third countries shall comply with or be equivalent to those applicable to the production and marketing of Community products. Where these rules are stricter than those laid down by the ‘Office International des Epizooties’ (OIE), specific provisions must make it possible to take account of the extent to which developing countries that export, or which are potential exporters, into the European Union are able to comply with such rules, as far as possible, without endangering the objective of a high level of animal and human health protection.
Justification The use of rules that are different from those laid down at international level can create obstacles to trade and problems for developing countries in particular, which are heavily dependent on export markets.
(Amendment 9) Article 9, paragraph 1
1.   Audits and/or inspections at all stages covered by this Regulation may be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal health rules. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection.	1.   Audits and/or inspections at all stages covered by this Regulation must be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal health rules. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection.
Justification Self-explanatory.
(Amendment 10) Article 9, paragraph 4
4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof.	4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof by means of the early-warning system.
Justification Self-explanatory.
(Amendment 11) Annex II, paragraph 2, subparagraph 2
The mark must be applied by or under the responsibility of the official veterinarian responsible for controlling the implementation of the animal health requirements.	The mark must be applied by the official veterinarian responsible for controlling the implementation of the animal health requirements.
Justification In parallel with the systematisation of the HACCP principle, the presence of veterinarians and their official activities must be maintained for the proper implementation of health principles and the enhancement of food safety.

• [1] OJ C 365, 19.12.2000, p. 123.

OPINION OF THE COMMITTEE ON THE ENVIRONMENT, PUBLIC HEALTH AND CONSUMER POLICY

7 November 2001

for the Committee on Agriculture and Rural Development

on the proposal for a Council regulation on animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

(COM(2000) 438 – C5‑0382/2000 – 2000/0181(CNS))

Draftsman: Horst Schnellhardt

PROCEDURE

The Committee on the Environment, Public Health and Consumer Policy appointed Horst Schnellhardt draftsman at its meeting of 29 August 2001.

It considered the draft opinion at its meeting of 6 November 2001.

At that meeting it adopted the following amendments unanimously.

The following were present for the vote: Caroline F. Jackson, chairman; Horst Schnellhardt, draftsman; Per-Arne Arvidsson, María del Pilar Ayuso González, John Bowis, Philip Bushill-Matthews, Martin Callanan, Anne Ferreira, Karl-Heinz Florenz, Laura González Álvarez, Robert Goodwill, Françoise Grossetête, Rosemarie Müller, Béatrice Patrie, Marit Paulsen, Frédérique Ries, Dagmar Roth-Behrendt, Giacomo Santini and Phillip Whitehead.

AMENDMENTS

The Committee on the Environment, Public Health and Consumer Policy calls on the Committee on Agriculture and Rural Development, as the committee responsible, to incorporate the following amendments in its report:

Text proposed by the Commission[1]	Amendments by Parliament
Amendment 1 First citation
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,	Having regard to the Treaty establishing the European Community, and in particular Article 152(4)(b), thereof,
Justification Of the four regulations and the directive which constitute this package of measures laying down rules governing the hygiene of foodstuffs, only this proposal for a regulation is based on Article 37 of the Treaty. That prevents the European Parliament from exercising its power of codecision. This regulation, which is directly connected with the common agricultural policy, will have a direct impact on the prevention of epizootic diseases which, in many cases, have a direct or indirect impact on the safety of the food chain and, consequently, on human health.
Amendment 2 Recital 9
(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include an evaluation of the animal health situation in the third countries concerned.	(9)   To that end, procedures must be introduced to prevent the introduction of epizootic diseases. Such procedures include an evaluation of the animal health situation in the third countries concerned. That evaluation must be carried out on a regular basis in order to take account of the current health situation in the countries concerned.
Justification Evaluation of the animal health situation in third countries must be carried out on a regular basis, given the rapidity with which some epizootic diseases spread.
Amendment 3 Recital 15
(15)   Provision must be made for the organisation of Community audits and inspections in order to ensure the uniform application of the animal health provisions.	(15)   Provision must be made for Community audits and inspections in order to ensure the uniform application of the animal-health provisions.
Justification This amendment is self-explanatory.
Amendment 4 Article 2
For the purposes of this Regulation, the definitions laid down in the Directives referred to in Annex I and, where applicable, in Council Regulation …/… on the hygiene of foodstuffs, shall apply.	For the purposes of this Regulation, the definitions laid down in the Directives referred to in Annex I and, where applicable, in Council Regulations…/… on the hygiene of foodstuffs and in the specific hygiene legislation applicable to products of animal origin for human consumption shall apply.
Justification This amendment is designed to combine all the relevant legal bases. It is already evident that definitions are already incorporated in the specific hygiene legislation.
Amendment 5 Article 4
Official controls shall be carried out by the competent authorities of the Member States to ensure compliance with this Regulation, its implementing rules and any safeguard measures applied to products of animal origin, pursuant hereto.	Official controls shall be carried out by the competent authorities of the Member States to ensure compliance with this Regulation, its implementing rules and any safeguard measures applied to products of animal origin, pursuant hereto.
	Every twelve months, the Member States shall submit to the Commission a report on the controls carried out which shows the frequency of the controls, the nature of the shortcomings and infringements discovered and the sanctions imposed by the competent authorities.
	The Member States shall submit the first such report no later than twelve months after the date on which this Regulation enters into force.
Detailed rules on these controls, their results and the decisions to be taken on the basis of those results shall be adopted in accordance with the procedure referred to in Article 11.	Detailed rules on these controls, their results and the decisions to be taken on the basis of those results shall be adopted in accordance with the procedure referred to in Article 11.
Justification It is important that the Commission should be put in a position where it can monitor the implementation of this Regulation.
Amendment 6 Article 5
Where infringements of the animal-health rules are found, action shall be taken to remedy the situation.	Where infringements of the animal-health rules are found, action shall be taken to remedy the situation and, where appropriate, to prohibit the production and placing on the market of the products.
	The European Commission must be notified thereof via the early-warning system.
Where the legal or natural person or persons involved in the infraction fail to remedy the situation within the time fixed by the competent authority, or if a serious animal-health risk is found, restrictions shall be placed on the production and marketing of the products concerned. Such restrictions may entail a ban on the production and marketing of products of animal origin and the withdrawal and, if necessary, destruction of products already placed on the market.	Where the legal or natural person or persons involved in the infraction fail to remedy the situation within the time fixed by the competent authority, or if a serious animal-health risk is found, restrictions shall be placed on the production and marketing of the products concerned. Such restrictions may entail a ban on the production and marketing of products of animal origin and the withdrawal and destruction of products already placed on the market. Such restrictions must be notified to the public in easily comprehensible terms.
Justification Irrespective of the deadline to be laid down in accordance with subparagraph 2, it must be made clear that even initial infringements of animal-health rules may, in serious cases, lead to a prohibition on the production and placing on the market of the products. Epizootic diseases caused by the placing on the market of contaminated products of animal origin may have a direct or indirect impact on human health. It is, therefore, appropriate that the early-warning system, redefined in the Regulation establishing the new Food Authority, should be profitably used in this area.
Amendment 7 Article 6, paragraph 1
1.   Experts from the Commission may, in cooperation with the competent authorities of the Member States, make audits and/or inspections at all stages in the production and marketing of products of animal origin as well as on the organisation and functioning of the competent authorities in the Member States, in order to ensure the uniform application of this Regulation, its implementing rules and any safeguard measures pursuant hereto. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection.	1.   Experts from the Commission may, in cooperation with the competent authorities of the Member States, make audits and/or inspections at all stages in the production and marketing of products of animal origin as well as of the organisation and functioning of the competent authorities in the Member States, in order to ensure the uniform application of this Regulation, its implementing rules and any safeguard measures pursuant hereto. Such inspections may be carried out without any prior notice being given. Commission experts may be accompanied by the competent authority of the Member State and any expert appointed by the Commission for the purpose of an audit and/or inspection.
Justification Events in recent years involving food safety have shown that inspections announced in advance do not always reveal the true situation in the undertakings. Like Member State inspectors, Commission experts should be able to carry out inspections without any prior notice being given.
Amendment 8 Article 6, paragraph 2
2.   The Commission shall communicate its general programme of audits and/or inspections to the Member States on a regular basis and shall inform them of the results.	2.   The Commission shall communicate its general programme of audits and/or inspections to the Member States on a regular basis and shall inform them of the results. It may carry out inspections in the Member States at any time, without any prior notice thereof being given, and it shall inform them of its findings.
Justification For the proper application of the Regulation, which is crucial for the prevention of epizootic diseases, it is essential that, in addition to normal audits, surprise inspections may be carried out. With regard to assistance from national authorities, the wording should be used of the legislative resolution of the European Parliament on the common position adopted by the Council with a view to the adoption of Directive 2001/…/(EC) of the European Parliament and of the Council of …amending Council Directive 95/33/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition (13724/1/2000 – C5-0047/2001 – 2000/0068(COD)).
Amendment 9 Article 6, paragraph 4
4.   To enable audits and/or inspections to be carried out efficiently, the Member State in whose territory an audit and/or inspection is undertaken shall give all necessary assistance and provide all documentation requested by the Commission experts for the purpose of the audit.	4.   In so far as it is necessary for the uniform application of the provisions of this Regulation, Commission experts may undertake on-the-spot inspections, in cooperation with the competent authorities of the Member State. The Member State on whose territory the inspection is carried out shall provide the experts with all the assistance which they may require in order to carry out their tasks. The Commission shall notify the competent authorities, the Member States and the European Parliament of the findings of the inspections carried out.
Justification See Amendment 8.
Amendment 10 Article 6, paragraph 6 a (new)
	6a.   On the basis of the annual reports referred to in Article 4 and of the Community audits and inspections also referred to in that Article, the Commission shall draw up a summary report on the application of the Regulation, of the implementing provisions and of the safeguard measures.
	In that summary report, the Commission shall review whether national authorities have imposed, in respect of any infringements of this Regulation which they have discovered, sanctions which are equivalent to sanctions imposed in other Member States in respect of similar infringements.
	Every twelve months, the Commission shall submit a summary report to Parliament and the Council. The first such summary report shall be submitted to Parliament and the Council no later than three months after the date laid down in the third paragraph of Article 4.
Justification The summary report will assist in the monitoring of the application of the Regulation. In this connection, it is important that any infringements are recorded and subject to the imposition of sanctions. Any disparity between the sanctions imposed in the various Member States in respect of similar infringements must be avoided. The Commission is therefore asked to ensure equal treatment.
Amendment 11 Article 9, paragraph 1
1.   Audits and/or inspections at all stages covered by this Regulation may be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal health rules. Commission experts may be accompanied by any other expert appointed by the Commission for the purposes of the audit and/or inspection.	1.   Audits and/or inspections at all stages covered by this Regulation must be carried out by experts from the Commission in third countries in order to verify compliance or equivalence with Community animal-health rules. Agreements must be reached with the third countries involved that on-the-spot inspections may be carried out without any prior notice being given. Commission experts may be accompanied by any other expert appointed by the Commission for the purposes of the audit and/or inspection.
Justification The provisions applicable to the Member States relating to inspections being carried out without any prior notice being given should also be extended to cover third countries (See Amendment 7).
Amendment 12 Article 9, paragraph 4
4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof.	4.   If during a Community audit and/or inspection a serious risk to animal health is identified, the Commission shall immediately take the measures necessary to safeguard animal health and shall immediately inform the Member States thereof, using the early-warning system.
Justification This amendment is self-explanatory.
Amendment 13 Article 11, paragraph 1
1.   The Commission shall be assisted by the Standing Veterinary Committee, instituted by Council Decision 68/361/EEC[2].	1.   The Commission shall be assisted by the Scientific Panel on Animal Health and Welfare set up in accordance with Article 28 of the Regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety.
Justification Epizootic diseases caused by the placing on the market of contaminated products of animal origin may have a direct or indirect impact on human health. It is, therefore, appropriate that the early-warning system, redefined in the Regulation establishing the new Food Authority, should be profitably used in this area.

• [1] OJ C …, 26.6.2001, p. 156.
• [2] OJ L 225, 18.10.1968, p. 23.

OPINION OF THE COMMITTEE ON FISHERIES

23 January 2001

of the Committee on Fisheries

for the Committee on the Environment, Public Health and Consumer Policy

on the proposal for a regulation of the European Parliament and of the Council on;

• (i)the hygiene of foodstuffs,
• (ii)laying down specific hygiene rules for food of animal origin,
• (iii)laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption

(COM(2000) 438 – C5‑0376/2000 – 2000/0178(COD))

(COM(2000) 438 – C5‑0377/2000 – 2000/0179(COD))

(COM(2000) 438 – C5‑0378/2000 – 2000/0180(COD))

on the proposal for a Council regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

(COM(2000) 438 – C5‑0382/2000 – 2000/0181(CNS))

on the proposal for a directive of the European Parliament and of the Council repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC

(COM(2000) 438 – C5‑0379/2000 – 2000/0182(COD))

Draftsman: Pat the Cope Gallagher

PROCEDURE

The Committee on Fisheries appointed Pat the Cope Gallagher draftsman at its meeting of 19 September 2000.

It considered the draft opinion at its meetings of 28 November 2000 and 22 January 2001.

At the latter meeting it adopted the amendments below unanimously.

The following were present for the vote: Daniel Varela Suanzes-Carpegna, chairman; Rosa Miguélez Ramos, vice-chairman; Niels Busk, Carmen Fraga Estévez, Salvador Jové Peres, Heinz Kindermann, Brigitte Langenhagen, Albert Jan Maat (for James Nicholson), Jens Dyhr Okking (for Nigel Paul Farage) and Catherine Stihler.

SHORT JUSTIFICATION

1.   Introduction

Since 1964, in response to the needs of the internal market and the necessity for high levels of protection, 17 different Council Directives have been adopted and developed to cover the areas of food hygiene and public health, official controls on products of animal origin and the animal health aspects of placing these products on the market.

This has resulted in a complex and confused situation, not least with regard to fisheries products and has led to the mixing of rules on hygiene, animal health and official controls and the existence of different hygiene regimes for products of animal origin and other food.

The aim of the current Commission proposals is to simplify and clarify the legislation by separating food hygiene issues from those relating to official controls and animal health and thus eliminate the inconveniences that were inherent in the piecemeal approach of the 17 Directives.

2.   The Commission Proposals

There are five separate proposals contained in the Commission package: 4 draft Regulations which take up, modify and consolidate the content of the various Directives and one draft Directive which would then repeal the original 17 Directives.

Proposals 1 and 2 deal with food hygiene. The first of these is a horizontal measure applicable to all food, while the second contains specific rules for food of animal origin. Proposal 3 deals with official controls on food of animal origin and proposal 4 deals with animal health issues, resulting from the consolidation of the hygiene rules and related to the production, placing on the market and importation of products of animal origin.

Proposal 1 - Hygiene of Foodstuffs

This draft Regulation, which would replace Directive 93/43/EEC on the hygiene of foodstuffs, contains the general hygiene rules applicable to all food and is based upon the following principles:

–   Food business operators must continue to have the primary responsibility for food safety,

–   The Hazard Analysis Critical Control Point (HACCP) principles prescribed by that Codex Alimentarius organisation should be introduced. It is proposed that this system should be mandatory for all food establishments and adopted as a management tool by food business operators to ensure food safety,

–   Food business operators must ensure traceability of food and food ingredients and must put in place products withdrawal procedures in case of food emergencies.

–   It should be applied from "farm to table",

–   Codes of good practice should be established by the various food sectors in order to give guidance to food business operators on food safety,

–   Imports from and imports to third countries must comply with Community hygiene standards,

–   Flexibility to cope with the special needs of small businesses and those operating in peripheral regions and remote areas such as mountains or islands. Special provision should be made for traditional food production and for the implementation of HACCP in particular in small businesses.

The possibility for granting derogations on an ad hoc basis is provided for.

A special Annex is devoted to primary production. It contains the elements that are considered essential to ensure food safety at that level, i.e.

–   Codes for good farming (fishing) practice,

–   Record keeping on food safety issues.

Proposal 2 - Specific Hygiene Rules for Food of Animal Origin

This draft Regulation provides for specific hygiene rules for food of animal origin (meat, milk, fish etc.) because of the different risks involved. These rules have been reduced from 14 different Directives into one much simplified text which offers more flexibility to food operators for defining the "in house" measures to be taken to ensure safe food.

This proposal also contains provisions to ensure flexibility for small enterprises and traditional food.

With regard to the fisheries sector, it covers the special hygiene conditions for the production, harvesting and transport of live bivalve molluscs, the rules for dispatch and purification centres and the health, labelling, packaging, storage and transport of the product.

In respect of fishery products, the Regulation lays down the conditions for fisheries vessels including factory and freezer ships and stipulates the hygiene requirements applicable on board, and during and after landing. Health standards for fishery products are also set out. Finally, measures are proposed relating to the wrapping and packaging of fishery products, their storage and transport and the approval and registration of establishments.

Proposal 3 - Official Controls on Products of Animal Origin

This proposal is a consolidation of the rules for official controls on products of animal origin, such as meat inspection and the control of harvesting areas for molluscs (Annex III). It represents mainly a consolidation of the multiplicity of control provisions scattered over the different Directives.

No major innovations have been introduced, but in some cases there has been a shift of emphasis, e.g. the need to perform controls throughout the length of the food chain.

In addition to the common control requirements, the official controls on fishery products should be carried out at the time of landing or before first sale at an auction or wholesale market. These should include organoleptic examination, chemical analysis and various other forms of surveillance testing.

The Commission proposes that the following should be declared unfit for human consumption

(a)   fishery products which the organoleptic, chemical, physical or microbiological checks show are not fit for human consumption;

(b)   fish or parts of fish which have not been properly examined to detect endo-parasites in accordance with Community legislation;

(c)   fishery products which contain in their edible parts contaminants present in the aquatic environment, such as heavy metals and organochlorinated substances, at levels where the calculated dietary intake would exceed the acceptable daily or weekly intake for humans;

(d)   poisonous fish and fishery products containing biotoxins;

(e)   fishery products or parts thereof considered dangerous to human health.

Proposal 4 - Animal Health Rules

Although not directly linked to hygiene, this proposal results from the recasting of the hygiene rules and is aimed at preventing the spread of animal diseases resulting from the placing on the market of products of animal origin.

The benefit of this proposal would be that all animal health rules would now be contained in a single instrument instead of being scattered over 7 Directives.

There are various provisions relating to the health of aquaculture fish and live molluscs.

Proposal 5 - Repeal Directive

This proposal would repeal all 17 Directives and has a standstill clause for existing implementing rules.

3.   Comments and Conclusions

The Committee on Fisheries welcomes these proposals and supports their objectives of simplification, coherence and consolidation, while at the same time maintaining a high level of protection for the consumer.

In particular, it supports the concept that food operators must bear full responsibility for the food they produce, so long as this is operated fair-handedly across the board and applied equally on the same basis to third country imports as to Community producers.

For this reason, the Committee also welcomes the Commission decision to formulate its proposals in the form of Regulations as opposed to Directives, so as to ensure a uniform regime throughout the Community. However, despite this, the fisheries sector will put great store by the provisions on flexibility.

Although traceability, "farm or sea to table" and the HACCP principles can all contribute to greater food safety and as such must be supported, the fisheries sector will be particularly concerned that adequate consideration is given to the special needs of the communities which it supports. Almost by definition, fishing is concentrated in remote or peripheral coastal regions, where few alternative sources of employment exist. In this context, any regulatory environment must be applied with great sensitivity.

Codes of good practice may in these circumstances represent the most practical solution and the most appropriate tool for the small and medium sized businesses which dominate the sector in these regions.

Article 1 of the hygiene of foodstuffs proposal and Annex I of proposal 2 on specific hygiene rules provide detailed definitions of primary and processed products and of live bivalve molluscs and fishery products. This represents a step forward for the fisheries sector.

Our committee has consistently made the point that while primary agricultural production has usually been taken to include fisheries products, fishing and aquaculture are covered by a quite separate common fisheries policy, providing for specific provisions in Community food law to cover the sector.

However, as recently as 1996, the Commission and Council, without consultation of the European Parliament, succeeded in foisting upon the fishing industry charges to finance veterinary inspections under a directive originally designed to deal with meat. (Council of Agriculture Ministers decision of 24-27 June 1996, with regard to the Commission proposal to modify Directives (EEC)85/73()[1], (EEC)90/675()[2] and (EEC)91/496)()[3].

Legislation must be based on an assessment of the risks involved. In this particular instance, however, this was patently obviously not the case, nor was any account taken of the specific nature of the "particular category of foodstuff" involved. Clear definitions and more transparent regulations should help to make such instances a thing of the past.

Conclusions

In conclusion, the Committee on Fisheries would point out that:

a)   A regulatory regime must take account of the varying degrees of risk presented by different businesses according to their operating practices. General and uniform principles can and should be adopted centrally. However, these must be applied sensitively in peripheral and remote areas dependent on a particular segment of the food production industry, while at the same time the strict application of the rules must continue to be guaranteed in all cases.

b)   The Fish Hygiene Directive (EEC) 91/493 [4] embraced the concept of self-monitoring and the responsibility of the industry to carry out its own controls. As the Commission states "the leitmotif throughout the recast of the hygiene rules is that food operators bear full responsibility for the safety of the food they produce. The implementation of hazard analysis and control principles and the observance of hygiene rules must ensure this safety."

The fisheries sector already operates under these principles.

• [1] OJ L 32, 5.2.1985, p. 14
• [2] OJ L 373, 31.12.1990, p. 1
• [3] OJ L 268, 24.9.1991, p. 56
• [4] OJ L 268, 24.9.1991, p. 15