8.2.2005   

EN

Official Journal of the European Union

L 35/1

(1)

Livestock production plays a very important part in the agricultural sector of the Community. Satisfactory results of this activity depend to a large extent on the use of safe and good quality feed.

(2)

The pursuit of a high level of protection of human and animal health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (3). That Regulation also lays down other common principles and definitions for national and Community food law, including the aim of achieving free movement of feed within the Community.

(3)

Council Directive 95/69/EC (4) established the conditions and arrangements applicable to certain categories of establishments and intermediaries in the animal feed sector, to enable them to exercise their activities. Experience has shown that these conditions and arrangements constitute a sound basis for ensuring feed safety. That Directive also established conditions for the approval of establishments producing certain substances listed in Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (5).

(4)

Commission Directive 98/51/EC of 9 July 1998 laying down certain measures for implementing Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector (6), established certain measures that included arrangements for imports from third countries.

(5)

Experience has also shown that it is necessary to ensure that all feed businesses, including aquaculture, operate in conformity with harmonised safety requirements and that it is necessary to conduct a general review in order to take into account the need to ensure a higher level of protection of human and animal health, and of the environment.

(6)

The principal objective of the new hygiene rules set out in this Regulation is to ensure a high level of consumer protection with regard to food and feed safety, taking particular account of the following principles:

(7)

In order to ensure the complete application of the registration and approval system to all the feed business operators and, consequently, to guarantee full traceability, it is appropriate to ensure that they only source and use feed from establishments which are registered and/or approved in accordance with this Regulation.

(8)

An integrated approach is necessary to ensure feed safety from, and including, primary production of feed up to, and including, its placing on the market or export. The primary production of feed includes products which only undergo simple physical treatment such as cleaning, packaging, storage, natural drying or ensiling.

(9)

In accordance with the principles of proportionality and subsidiarity, Community rules should not apply to certain cases of private domestic production of feed and feeding of certain animals, nor to the direct supply of small quantities of primary production of feed at local level, nor to the retailing of pet food.

(10)

Feed hazards present at the level of primary production of feed should be identified and adequately controlled, to ensure that the objectives of this Regulation are met. The fundamental principles of this Regulation should therefore apply to farms which manufacture feed solely for the requirements of their own production, as well as to farms which place feed on the market. It should be taken into consideration that the risk is less if feed is produced and used for feeding animals only used for domestic consumption, or for animals which are not used for food production. The trade of small quantities of feed products at local level and the retailing of pet food shall have particular treatment in the framework of this Regulation.

(11)

The application of HACCP principles to primary production of feed is the medium-term objective of European hygiene legislation. But guides to good practice should already be encouraging the use of appropriate hygiene requirements.

(12)

Feed safety depends on a number of factors. Legislation should lay down minimum hygiene requirements. Official controls should be in place to check feed business operators’ compliance. In addition, feed business operators should take measures or adopt procedures to achieve a high level of feed safety.

(13)

HACCP principles can help feed business operators attain a higher standard of feed safety. HACCP principles should not be regarded as a method of self-regulation and do not replace official controls.

(14)

The implementation of the HACCP principles requires the full cooperation and commitment of feed businesses’ employees.

(15)

HACCP principles in feed production should take into account the principles contained in the Codex Alimentarius, but should allow sufficient flexibility in all situations. In certain feed business, it is not possible to identify critical control points and, in some cases, good practices can replace the monitoring of critical control points. Similarly, the requirement to establish ‘critical limits’, as set out in the Codex Alimentarius, does not require a numerical limit to be fixed in every case. The requirement to retain documents as set out in the same Code needs to be flexible to avoid undue burdens for very small businesses. It should be ensured that operations carried out by a feed business at the level of primary production of feed, including associated operations, as well as the mixing of feed with complementary feedingstuffs for the exclusive requirements of its own holding, are not obliged to follow the HACCP principles.

(16)

Flexibility is also necessary to accommodate the needs of feed businesses situated in regions suffering from special geographical constraints or related to structural requirements. But such flexibility should not compromise feed hygiene objectives. Provision should be made for discussion within the Standing Committee on the Food Chain and Animal Health, where appropriate.

(17)

A system of registration and approval by the competent authority of the Member State of all feed businesses is appropriate to ensure traceability from manufacturer to final user and to facilitate the implementation of effective official controls. The existing systems for collection of data concerning feed businesses may be used by the competent authority of the Member States to start up and implement the system provided for in this Regulation.

(18)

It is appropriate that an approval system for feed businesses be maintained for activities which can present a higher risk in the manufacture of feed. Provision should be made for procedures to extend the current scope of the approval system provided for in Directive 95/69/EC.

(19)

In order to be approved or registered, feed businesses should meet several conditions relevant to their operations, concerning facilities, equipment, personnel, production, quality control, storage and documentation, in order to ensure both feed safety and product traceability. Provision should be made for these conditions to be varied, to ensure that they are appropriate to the various types of feed business. Member States should be allowed to grant conditional approval of establishments, if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. However, it is also appropriate to set a maximum length of time for such conditional approval.

(20)

Provision should be made for temporarily suspending, amending or revoking the registration or approval, where establishments change or cease their activities or no longer fulfil the conditions applicable to their activity.

(21)

The traceability of feed and feed ingredients throughout the feed chain is an essential element in ensuring feed safety. Regulation (EC) No 178/2002 contains rules to ensure the traceability of feed and feed ingredients and provides a procedure for the adoption of implementing rules applicable to specific sectors.

(22)

Successive feed crises have shown that failures at any stage in the feed chain can have important economic consequences. The characteristics of feed production and the complexity of the feed distribution chain mean that it is difficult to withdraw feed from the market. The costs of rectifying the economic damage along the feed and food chain is often borne by public funds. The remedying of this economic consequence at a low cost to society could be improved if the operator whose activity causes economic damage in the feed sector is held financially responsible. However, establishing a general mandatory system of financial liability and financial guarantees, for example through insurance, which applies to all feed business operators may not be feasible or appropriate. The Commission should therefore consider this issue in greater depth, taking into account provisions in existing legislation with regard to liability in other spheres, as well as existing systems and practices amongst the Member States. To this end, the Commission should present a report, accompanied where appropriate by legislative proposals.

(23)

Feed imported into the Community must satisfy the general requirements laid down in Regulation (EC) No 178/2002 and the import conditions laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (7). In order to avoid trade disruptions it is appropriate that, pending the completion of the implementing measures, imports continue to be authorised under the conditions laid down in Directive 98/51/EC.

(24)

Community products exported to third countries have to satisfy the general requirements laid down in Regulation (EC) No 178/2002.

(25)

It is appropriate to broaden the scope of the rapid alert system for food and feed laid down by Regulation (EC) No 178/2002 to include risks to animal health or the environment from feed used for animals not kept for food production.

(26)

Community legislation on feed hygiene has to be underpinned by scientific advice. To this end, the European Food Safety Authority should be consulted whenever necessary.

(27)

To take account of technical and scientific progress, there should be close and effective cooperation between the Commission and the Member States within the Standing Committee on the Food Chain and Animal Health.

(28)

This Regulation takes account of international obligations laid down in the WTO Sanitary and Phytosanitary Agreement and the international food safety standards contained in the Codex Alimentarius.

(29)

The Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties have to be effective, proportionate and dissuasive.

(30)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (8).

(31)

It is appropriate to provide for a deferred date of application of the Regulation, in order to allow the feed businesses affected by it time to adapt.

(32)

For the above reasons, Directives 95/69/EC and 98/51/EC should be repealed,

(a)

general rules on feed hygiene;

(b)

conditions and arrangements ensuring traceability of feed;

(c)

conditions and arrangements for registration and approval of establishments.

(a)

the activities of feed business operators at all stages, from and including primary production of feed, up to and including, the placing of feed on the market;

(b)

the feeding of food-producing animals;

(c)

imports and exports of feed from and to third countries.

(a)

the private domestic production of feed:

(b)

the feeding of food-producing animals kept for private domestic consumption or for the activities mentioned in Article 1(2)(c) of Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (9);

(c)

the feeding of animals not kept for food production;

(d)

the direct supply of small quantities of primary production of feed at local level by the producer to local farms for use on those farms;

(e)

the retailing of pet food.

(a)

‘feed hygiene’ means the measures and conditions necessary to control hazards and to ensure fitness for animal consumption of a feed, taking into account its intended use;

(b)

‘feed business operator’ means the natural or legal person responsible for ensuring that the requirements of the present Regulation are met within the feed business under their control;

(c)

‘feed additives’ means substances or micro-organisms authorised under Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (10);

(d)

‘establishment’ means any unit of a feed business;

(e)

‘competent authority’ means the authority of a Member State or of a third country designated to carry out official controls;

(f)

‘primary production of feed’ means the production of agricultural products, including in particular growing, harvesting, milking, rearing of animals (prior to their slaughter) or fishing resulting exclusively in products which do not undergo any other operation following their harvest, collection or capture, apart from simple physical treatment.

(a)

transport, storage and handling of primary products at the place of production;

(b)

transport operations to deliver primary products from the place of production to an establishment;

(c)

mixing of feed for the exclusive requirements of their own holdings without using additives or premixtures of additives with the exception of silage additives,

(a)

comply with specific microbiological criteria;

(b)

take measures or adopt procedures necessary to meet specific targets.

(a)

identify any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b)

identify the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or reduce it to acceptable levels;

(c)

establish critical limits at critical control points which separate acceptability from unacceptability, for the prevention, elimination or reduction of identified hazards;

(d)

establish and implement effective monitoring procedures at critical control points;

(e)

establish corrective action when monitoring indicates that a critical control point is not under control;

(f)

establish procedures to verify that the measures outlined in points (a) to (e) are complete and working effectively. Verification procedures shall be carried out regularly;

(g)

establish documents and records commensurate with the nature and size of the feed businesses to demonstrate the effective application of the measures set out in points (a) to (f).

(a)

provide the competent authority with evidence of their compliance with Article 6 in the form requested by the competent authority;

(b)

ensure that any documents describing the procedures developed in accordance with Article 6 are up-to-date at all times;

(a)

notify the appropriate competent authority of any establishments under their control, active in any of the stages of production, processing, storage, transport or distribution of feed, in the form required by the competent authority with a view to registration;

(b)

provide the competent authority with up-to-date information on any establishments under their control as referred to in point (a), including notifying the competent authority of any significant change in activities and any closure of an existing establishment.

(1)

such establishments carry out one of the following activities:

(2)

approval is required under the national law of the Member State where the establishment is located;

or

(3)

approval is required by a Regulation adopted in accordance with the procedure referred to in Article 31(2).

(a)

registration as provided for in Article 9;

or

(b)

approval, when required in accordance with Article 10.

(a)

the establishment ceases one or more of its activities;

(b)

it is shown that the establishment has not fulfilled the conditions applicable to its activities, for a period of one year;

(c)

it identifies serious deficiencies or has had to stop production at an establishment repeatedly and the feed business operator is still not able to provide adequate guarantees regarding future production.

(a)

in consultation with representatives of parties whose interests may be substantially affected, such as competent authorities and user groups;

(b)

having regard to relevant codes of practice of the Codex Alimentarius;

and

(c)

when they concern primary production of feed, having regard to the requirements set out in Annex I.

(a)

they have been developed in accordance with paragraph 1;

(b)

their contents are practicable for the sectors to which they refer;

and

(c)

they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned.

(a)

by or in consultation with appropriate representatives of European feed business sectors and other interested parties, such as consumer groups;

(b)

in collaboration with parties whose interests may be substantially affected, including competent authorities.

(a)

relevant codes of practice of the Codex Alimentarius,

and

(b)

when they concern primary production of feed, the requirements set out in Annex I.

(a)

they have been developed in accordance with paragraphs 2 and 3;

(b)

their contents are practicable throughout the Community for the sectors to which they refer;

and

(c)

they are suitable as guides for compliance with Articles 4, 5 and 6, in the sectors and/or for the feeds concerned.

(a)

the third country of dispatch appears on a list, drawn up in accordance with Article 48 of Regulation (EC) No 882/2004, of third countries from which imports of feed are permitted;

(b)

the establishment of dispatch appears on a list, drawn up and kept updated by the third country in accordance with Article 48 of Regulation (EC) No 882/2004, of establishments from which imports of feed are permitted;

(c)

the feed was produced by the establishment of dispatch or by another establishment appearing on the list referred to in point (b) or in the Community;

and

(d)

the feed satisfies:

(a)

the development of codes of good practice;

(b)

the experience gained from the implementation of HACCP-based systems pursuant to Article 6;

(c)

technological developments;

(d)

scientific advice, particularly new risk assessments;

(e)

the setting of feed safety targets;

and

(f)

the development of requirements relating to specific operations.

(a)

Council Directive 95/69/EC;

(b)

Commission Directive 98/51/EC.

8.2.2005   

EN

Official Journal of the European Union

L 35/23

(1)

The Treaty requires the Commission to submit reports to the Council in order to enable the Council to monitor economic developments in each of the Member States and in the Community as well as the consistency of economic policies with certain broad guidelines.

(2)

According to the Treaty, the Commission must submit proposals to the Council for implementing the common commercial policy and the Council must authorise the Commission to open the necessary negotiations.

(3)

The implementation and the review of trade agreements, including the General Agreement on Trade in Services (GATS) (3) and the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) (4), as well as the current and future negotiations on further agreements, call for the relevant statistical information to be made available.

(4)

Council Regulation (EC) No 2223/96 of 25 June 1996 on the European System of national and regional accounts in the Community (5) (ESA 95) contains the reference framework of common standards, definitions, classifications, and accounting rules for drawing up the accounts of the Member States for the statistical requirements of the Community, in order to obtain comparable results between Member States.

(5)

The Action Plan on EMU Statistical Requirements presented to the Council in September 2000 and the 3rd, 4th and 5th Progress Reports, also supported by the Council, provide for quarterly European accounts by the institutional sector within 90 days. The timely provision of quarterly balance-of-payments figures is a prerequisite for the compilation of these quarterly European accounts.

(6)

Council Regulation (EC, Euratom) No 58/97 of 20 December 1996 on Structural Business Statistics (6), established a common framework for the collection, compilation, transmission and evaluation of Community statistics on the structure, activity, competitiveness and performance of businesses in the Community and sets out the characteristics which should be collected in this area.

(7)

Regulation (EC) No 2560/2001 of the European Parliament and of the Council of 19 December 2001 on cross-border payments in euro (7), had a direct impact on the collection of statistics; an increase in the threshold provided for in that Regulation would have a significant impact on the reporting burden of undertakings and on the quality of balance of payments statistics of Member States, especially in the Member States that have collection systems based on settlements.

(8)

Collectively, the Balance of Payments Manual of the International Monetary Fund, the Guideline of the European Central Bank (ECB) of 2 May 2003 on the statistical reporting requirements of the European Central Bank in the field of balance of payments and international investment position statistics, and the international reserves template (8), the Manual on statistics of international trade in services of the United Nations, and the OECD Benchmark Definition of Foreign Direct Investment, define the general rules for compiling statistics on balance of payments, international trade in services, and foreign direct investment.

(9)

In the field of balance of payments statistics, the ECB and the Commission coordinate work on compilation issues as appropriate. This Regulation defines in particular the statistical information that the Commission needs from the Member States in order to produce Community statistics on balance of payments, international trade in services and foreign direct investment. For the purposes of producing and disseminating those Community statistics, the Commission and the Member States consult with each other on matters concerning the quality of the data supplied and its dissemination.

(10)

Council Regulation (Euratom, EEC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (9), provides that national rules on statistical confidentiality may not be invoked to prevent the transmission of confidential statistical data to the Community authority (Eurostat) where an act of Community law governing a Community statistic provides for the transmission of such data.

(11)

Council Regulation (EC) No 2533/98 of 23 November 1998 concerning the collection of statistical information by the European Central Bank (10), lays down a confidentiality regime that applies to confidential statistical information transmitted to the ECB.

(12)

The production of specific Community statistics is governed by the rules set out in Council Regulation (EC) No 322/97 of 17 February 1997 on Community statistics (11).

(13)

There is a clear need to produce Community statistics on balance of payments, international trade in services and foreign direct investment which follow common statistical quality standards.

(14)

Since the objective of this Regulation, namely the creation of common statistical quality standards for the production of comparable statistics on balance of payments, international trade in services and foreign direct investment, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(15)

In order to guarantee the fulfilment of the obligations laid down in this Regulation, the national institutions responsible for the collection of data within the Member States may need to gain access to administrative data sources such as business registers held by other public institutions and to other databases containing information on cross-border transactions and positions, wherever such data are necessary for the production of Community statistics.

(16)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12),

(a)

balance of payments euro indicators;

(b)

balance of payments quarterly statistics;

(c)

international trade in services;

(d)

foreign direct investment (FDI) flows;

(e)

FDI positions.

(a)

the updating of the definitions (Annex II);

(b)

the updating of data requirements, including submission deadlines as well as revisions, extensions and eliminations of data flows (Annex I).

(a)

record the quality of the statistics produced;

(b)

assess the benefits accruing to the Community, the Member States and the providers and users of statistical information of the statistics produced in relation to the costs;

(c)

identify areas for potential improvement and amendments considered necessary in the light of the results obtained;

(d)

review the operation of the Committee and recommend whether the scope of implementing measures should be redefined.