Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the hygiene of foodstuffs

EXPLANATORY MEMORANDUM

I. PROCEDURE

1. On 14 July 2000, the Commission adopted a package of five proposals aiming to recast Community food hygiene legislation [Document COM (2000) 438]. The proposal was submitted to the Council and the European Parliament on 24 July 2000 for adoption by co-decision (except proposal 2000/0181, which is based on Article 37 of the Treaty).

2. On 15 May 2002, the European Parliament has in first reading given a favourable opinion on three of the five proposals of the package.

3. The present proposal amends the first proposal on the hygiene of foodstuffs [document 2000/0178 (COD)] of the package so as to take into account the amendments of the European Parliament that were accepted by the Commission.

4. With regard to proposal 2000/0178 (COD), the European Parliament adopted 102 amendments, 72 of which were accepted by the Commission. Mr. Byrne had indicated to the Plenary meeting on 14 May 2002 that he could accept most of the amendments, wholly or in part, and subject to drafting amendments, except amendments 5, 8, 13, 14, 28-30, 35, 37-39, 47, 48, 53, 55, 58, 59, 67, 69, 71, 76, 77, 83, 89, 92, 93, 95, 105, 107 and 108.

The amendments are in bold and underlined. A number of amendments have been reformulated so as to ensure consistency of the terminology used throughout the proposal. Extensive editorial changes are mentioned below.

Deletions have not been systematically indicated. Such indications would in certain cases have lead to structural complications without offering more transparency. Deletions concern in particular the definitions in Article 2 (certain definitions have been deleted in order to avoid overlap with Regulation (EC) No 178/2002) and Article 10 (deleted for the same reason). Amendments concerned: 18-24, 50, 54.

Annex I has been completely replaced by a newly structured text.

The numbering of the Articles has been adapted due to the integration of Article 6 into Article 4, and the deletion of Article 10.

Within certain Articles, the numbering of the paragraphs has been adapted in order to take into account the addition or deletion of elements in the Commission proposal.

5. Certain technical changes have been made to the text to ensure its conformity with the Inter-institutional Agreement of 22 December 1998 on common guidelines for the quality of drafting of Community legislation (OJ C 73, 17.3.1999, p. 1), drawn up pursuant to Declaration No 39 annexed to the Final Act of Amsterdam on the quality of the drafting of Community legislation. In accordance with points (b) and (g) of that Agreement, the text has been revised to take account of the common guidelines and the Joint Practical Guide drawn up under point (d) thereof.

II. OBJECTIVES OF THE PROPOSAL

6. The first proposal of the package aims to establish a common basis for the hygiene to be respected by all food business operators. It contains the following key-issues:

- It applies from farm to table.

- Food business operators have the prime responsibility over food safety.

- The HACCP (Hazard Analysis Critical Control Point) system is proposed as a tool to be implemented by food business operators in order to control microbiological and chemical hazards in food and thus to promote food safety.

- The establishment of guides to good practice by the food sectors in order to give guidance to food business operators on food safety and the implementation of HACCP.

- Flexibility for food businesses in remote areas, for traditional food production and for the implementation of HACCP in small businesses.

- The registration of all food businesses with the competent authority.

- Technical issues (premises, equipment etc.) to be respected by food businesses.

7. The proposal corresponds to action 8 in the Annex to the White Paper on Food Safety.

III. OVERVIEW OF AMENDMENTS OF THE EUROPEAN PARLIAMENT

8. Technical/editorial amendments

The majority of the proposed amendments aim to improve the proposal from a technical and editorial point of view. These amendments have largely been taken over by the Commission (Amendments concerned: 2, 4, 6, 9-partly, 10, 23, 25, 26, 39, 41, 51, 52, 65, 66, 68, 70, 72, 73, 74, 75, 78, 79, 80, 81, 82, 84, 85, 86, 87, 88, 90, 91, 94, 96, 97, 98, 99, 100, 101, 102, 106).

9. Relation with Regulation 178/2002 (General Food Law)

A number of amendments aim to bring the proposal in line with the recently adopted Regulation (EC) No 178/2002 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. These amendments have largely been taken over by the Commission. (Amendments concerned: 1, 3, 11, 12, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 27, 50, 54, 56, 57, 61).

Amendment 107 overlaps with Regulation (EC) No 178/2002 and has therefore not been taken into account.

10. Scope (Article 1)

Amendment 103 aims to clarify that the proposal does not apply to the direct supply of small quantities of primary products to the final consumer and to the local retail trade. The Commission has followed this amendment since it considers that the operations covered by it are a matter of subsidiarity. In the amended proposal, the Commission has clarified however that local retail trade refers to, as explained in the justification to the amendment, local shops and restaurants.

11. Comitology (Article 4 1, 2 and 3, Article 13)

The Commission proposed a regulatory procedure for completing and amending the Annexes to the Regulation, as well as for granting derogations thereto (the latter mandate existing already in Article 3 paragraph 3 of Directive 93/43/EEC). The European Parliament did not follow the Commission's proposal. The amendments of the Parliament on this subject have not been taken over by the Commission. (Amendments concerned: 28, 29, 30, 58 and 59).

12. Microbiological and other criteria or standards

Amendment 106 provides for a redraft of the Commission proposal with regard to the setting of microbiological criteria, temperature criteria, food safety targets and performance standards. This amendment sets a clear framework for future decisions on important food safety factors, and is therefore a welcome precision to the Commission's proposal. It must be ensured however that the same terminology is used consistently throughout the amendment. The Commission has therefore introduced some drafting changes to this amendment.

13. Flexibility (Article 4 4)

The proposal introduces flexibility for traditional food production, remote areas and the implementation of HACCP. Furthermore, the text offers flexibility on technical matters through the introduction of the terms "where necessary", "where appropriate". The method for granting flexibility is largely based on subsidiarity. It will be mainly small businesses taking a profit of this flexibility.

The need for flexibility is generally endorsed. Certain amendments aim to better describe where and how flexibility applies, and are therefore endorsed by the Commission, subject to some editorial changes. (Amendments concerned: 31, 32).

14. Hazard Analysis Critical Control Point system (HACCP) (Article 5)

The proposal imposes the HACCP system to all food businesses except those at the level of primary production (farmers) where hazards should be controlled by the use of guides to good farming practice. Several amendments aimed to introduce the HACCP system at the level of primary production. These are not accepted by the Commission, since the general application of the HACCP system at the level of primary production is considered too ambitious. (Amendments concerned: 8, 9-first part, 35, 37, 38, 67).

One amendment introduces flexibility for the application of HACCP (36-first part). This is favourably accepted by the Commission. However, the second part of amendment 36 imposes documentation on HACCP procedures to be kept for an extensive period in time. It is considered that such a requirement, as a general rule, is unrealistic in particular in the case of very small enterprises.

15. Guides to good practice (Articles 6 and 7)

The proposal introduces the possibility to establish guides to good practice which are a voluntary instrument that can be used by food business as an assist in ensuring a high level of food hygiene. Two amendments aim to clarify that guides are a voluntary instrument (40, 45). One amendment aims to preserve status of guides developed under former rules (44). Three amendments aim to clarify the procedure on how guides should be established (42, 43, 46). These amendments have been introduced into the amended proposal with some drafting amendments.

Amendment 48 aims to ensure that Community guides prevail. The Commission believes that since both national and Community guides are voluntary instruments, food business operators should have free choice to implement either.

16. Registration of food businesses (Article 8)

The proposal provided for a systematic registration of all food businesses with the competent authority, and to apply the registration number to the food that is placed on the market (for traceability purposes). Amendment 49 aims to introduce flexibility in the registration procedure. Amendment 50 aims to repeal the requirement for placing the registration number on the food, since traceability is adequately covered by Regulation (EC) No 178/2002. Both amendments are in line with the Commission's policy and are therefore accepted.

However, amendment 53 aims to introduce a new requirement for the traceability of food. Since this overlaps with Regulation (EC) No 178/2002, the amendment is not followed.

17. Duties for competent authorities

The proposal defines the duties of food business operators and not the duties of the competent authorities (that are the subject of separate legislation). However, amendments 55 and 108 aim to introduce duties for the competent authorities and fall therefore outside the scope of the proposal.

18. Support for developing countries

Amendment 13 aims to establish a support for developing countries. Although such a support is an obligation under the WTO/SPS code, the proposal on food hygiene does not seem to be the right place to introduce such a requirement into Community law. The Commission will reflect on this question in the context of possible future proposals that have a more generic impact on food law.

19. Report on implementation

The proposal contains a provision for the Commission to present a report to the EP and Council within 7 years of the Regulation entering into force, reviewing the experience gained from implementing the Regulation. Amendment 62 aims to reduce the period of 7 years to 5 years. This seems a reasonable timeframe for the Commission to get the necessary experience with the new Regulation and to present a report on its implementation.

20. Date of entry into force

The proposal foresees that the Regulation enters into force on the date of its publication and applies on the date of 1.1.2004. Amendment 63 makes the Regulation applicable "one year after its entry into force". This seems a realistic approach.

21. Annex I on primary production

Amendments 64-74 aim to ensure a new presentation of the duties imposed on the primary production sector, and they must therefore be considered as an editorial issue. The Commission has taken over the main ideas of these amendments but has taken the freedom to re-draft a number of the amendments so as to ensure coherence with other parts of the proposal and to ensure a consistent approach as regards terminology.

22. Technical requirements in Annex II

The amendments to Annex II generally aim to improve the proposal from a technical point of view. Certain of these amendments risk however to create difficulties for very small enterprises. These amendments were not accepted by the Commission. Amendments concerned: 76, 83, 101.

23. Pursuant to Article 250(2) of the EC-Treaty, the Commission amends it proposals in accordance with the lines set out above.

2000/0178 (COD)

Amended proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the hygiene of foodstuffs

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 95 and 152(4)(b) thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C ...

Having regard to the opinion of the European Economic and Social Committee [2],

[2] OJ C ...

Having regard to the opinion of the Committee of the Regions [3]

[3] OJ C ...

Acting in accordance with the procedure laid down in Article 251 of the Treaty,

Whereas:

(1) The protection of human health is of paramount importance. The fundamental principles to be observed with a view to attaining a high level of protection are laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council 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 [4].

[4] OJ L 31, 1.2.2002, p. 1.

(2) In the context of the internal market, Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs [5] has been adopted in order to ensure the safety of foodstuffs for human consumption in free circulation.

[5] OJ L 175, 19.7.1993, p. 1.

(3) Directive 93/43/EEC fixes the principles with regard to the hygiene of foodstuffs and in particular:

- the standard of hygiene throughout all stages of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the final consumer,

- the need to base the standard of hygiene on the use of hazard analysis, risk assessment and other management techniques to identify, control and monitor critical points,

- the possibility of adopting microbiological criteria and temperature control requirements for certain classes of foodstuffs in accordance with scientifically accepted general principles,

- the development of guides to good hygiene practice to which food businesses may refer,

- the need for the competent authorities of the Member States to ensure the observance of the hygiene rules with the aim of preventing the final consumer from being harmed by foodstuffs unfit for human consumption,

- the obligation on food business operators to ensure that only foodstuffs not harmful to human health are placed on the market.

(4) Experience has shown that these principles constitute a sound basis for ensuring the safety of foodstuffs.

(5) In the context of the common agricultural policy, specific health rules affecting the production and placing on the market of products included in the list contained in Annex I to the Treaty have been established;

(6) These health rules have not always sufficiently ensured that barriers to trade for the products concerned were removed, and thus have not fully contributed to the creation of the internal market.

(7) These specific rules are contained in a large number of Directives.

(8) With regard to public health, these Directives contain common principles such as those related to the responsibilities of manufacturers of products of animal origin, the obligations of the competent authorities, the technical requirements for the structure and operation of establishments handling products of animal origin, the hygiene requirements which must be complied with in these establishments, the procedures for the approval of establishments, the conditions for storage and transport, the health marking of the products.

(9) Many of these principles are the same as the principles laid down in Directive 93/43/EEC.

(10) The principles laid down in Directive 93/43/EEC can therefore be considered to be a common basis for the hygienic production of all foodstuffs, including products of animal origin included in Annex I to the Treaty.

(11) In addition to this common basis, specific hygiene rules are needed in order to take the specificity of certain foodstuffs into account. For products of animal origin those rules are contained in Regulation (EC) No .../... of the European Parliament and of the Council laying down specific hygiene rules for foodstuffs of animal origin [6].

[6] OJ L ...

(12) The principle objective of the general and specific hygiene rules is to ensure a high level of consumer protection with regard to the safety of foodstuffs, taking into account in particular:

- the principle that primary responsibility for the safety of foodstuffs rests with the food business operator within the scope of its own activities,

- the need to ensure the safety of foodstuffs throughout the food chain, starting with primary production;

- the need to maintain the cold chain for foodstuffs that cannot safely be stored at ambient temperatures, especially for frozen foodstuffs;

- the general implementation of the hazard analysis critical control points (HACCP) system which, together with the application of good hygiene practice, should reinforce the responsibility of food business operators;

- the value of guides to good practice which include guidance for food business operators at all levels of the food chain on the compliance with food hygiene rules;

- the need to carry out official controls at all stages of production, manufacture and placing on the market;

- the establishment of microbiological criteria and temperature control requirements based on a scientific assessment of risk;

- the need to ensure that imported foodstuffs are of at least the same or an equivalent health standard.

(13) The safety of foodstuffs from the place of primary production up to the point of sale to the consumer requires an integrated approach where all food business operators must ensure that the safety of foodstuffs is not compromised.

(14) Food hazards already present at the level of primary production must be identified and adequately controlled.

(15) HACCP is an instrument to help food business operators attain a higher standard of food safety. HACCP should not be regarded as a method of self-regulation and does not replace official controls.

(16) Hygiene at farm level can be organised through the use of codes of good practice, supplemented where necessary with specific hygiene rules to be observed during the production of primary products. Although application of the full HACCP system in the primary sector is currently not generally feasible from a practical point of view, the possible introduction of its principles should be examined.

(17) Food safety is a result of several factors including the respect of mandatory requirements, the implementation of food safety programmes established and operated by food business operators and the implementation of the HACCP system.

(18) The HACCP system in the production of foodstuffs should take account of the principles already laid down by the Codex Alimentarius allowing at the same time the flexibility needed for its application in all situations, and in particular in small businesses.

(19) Flexibility is also needed so as to take account of the specific character of traditional ways of the production of foodstuffs and of the supply difficulties that may arise due to geographical constraints; such flexibility must not however compromise the objectives of food safety.

(20) For foodstuffs which cannot be safely stored at ambient temperatures, the maintenance of the integrity of the cold chain is a basic principle of the hygiene of foodstuffs;

(21) The implementation of the hygiene rules must be guided by the setting of objectives such as pathogen reduction targets or performance standards and it is necessary to provide for the procedures for that purpose.

(22) The traceability of foodstuffs and foodstuff ingredients along the food chain is an essential element in ensuring food safety. Rules to ensure traceability of food and food ingredients and procedures to implement these provisions in the specific sectors, are already contained in Regulation (EC) No 178/2002.

(23) Food businesses should be registered with the competent authority in order to allow official controls to be performed efficiently.

(24) Food business operators must give all assistance required in order to ensure that official controls can be carried out efficiently by the competent authorities.

(25) In accordance with Articles 11 and 12 of Regulation (EC) No 178/2002, food imported into, or exported from the Community should follow the hygiene principles laid down in this Regulation, unless specific circumstances are met.

(26) Scientific advice must underpin Community legislation on the hygiene of foodstuffs; to this end, the European Food Safety Authority should be consulted wherever necessary.

(27) In order to take account of technical and scientific progress, a procedure should be available to adopt certain requirements called for in the present Regulation.

(28) The present Regulation takes into account the international obligations laid down on the WTO-Sanitary and Phytosanitary Agreement and in Codex Alimentarius.

(29) The present recasting of existing Community food hygiene rules means that the existing hygiene rules can be repealed, including those laid down in Directive 93/43/EEC, which will be further harmonised by this Regulation; this is achieved through European Parliament and Council Directive .../.../EC repealing certain Directives on the hygiene of foodstuffs and on 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 [7].

[7] OJ L ...

(30) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EEC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [8], they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.

[8] OJ L 184, 17.7.1999, p. 23.

(31) It is necessary and appropriate for the achievement of the basic objectives of this Regulation to provide for the further approximation of concepts, principles and procedures previously established under Directive 93/43/EEC. In accordance with the principles of proportionality as set out in Article 5 of the Treaty, this Regulation does not go beyond what is necessary in order to achieve the objectives pursued,

HAVE ADOPTED THIS REGULATION:

Article 1 Scope

1. This Regulation lays down the rules to ensure the hygiene of foodstuffs at all stages of production, processing and distribution. This Regulation shall apply without prejudice to more specific food safety requirements applicable to certain categories of foodstuffs, and in particular to food of animal origin, and to rules relating to nutrition or compositional matters.

2. This Regulation shall not apply to:

(a) the primary production of foodstuffs for private domestic use;

(b) the domestic preparation of foodstuffs for private consumption;

(c) the direct supply by the producer of small quantities of primary products to the final consumer or to local shops and restaurants; such operations shall be subject to national rules.

Article 2 Definitions

For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002 shall apply. In addition, the following definitions shall apply:

(a) "food hygiene", hereinafter called "hygiene" means the measures and conditions necessary to control hazards and ensure fitness for human consumption of a foodstuff taking into account its intended use;

(b) "competent authority/ies" means the central authority/ies of a Member State responsible for the purposes and controls set out in this Regulation or any other authority or body to which competence has been delegated by the central authority/ies;

(c) "certification" means the procedure by which the competent authorities provide written or equivalent assurance of conformity to requirements;

(d) "equivalence" means the capability of different systems to meet the same objectives;

(e) "contamination" means the presence of a substance not intentionally added to foodstuffs or present in the food environment, which may compromise the safety or fitness for human consumption of the foodstuffs;

(f) "wrapping" means the protection of a product by the use of a wrapping or container in direct contact with the product concerned, and the wrapper or container itself;

(g) "packaging" means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself; if wrapping is strong enough to ensure effective protection, it can be considered to be packaging;

(h) "products of animal origin" means foodstuffs obtained from animals, including honey and blood;

(i) "product of plant origin" means foodstuffs obtained from plants;

(j) "unprocessed product" means foodstuffs which have not undergone a treatment, including products which have been, for example, divided, parted, severed, boned, minced, skinned, ground, cut, cleaned, trimmed, husked or milled, chilled, frozen or deep-frozen;

(k) "processed product" means foodstuffs resulting from the application to unprocessed products of a treatment such as heating, smoking, curing, maturing, pickling, drying, marinating, extraction, extrusion etc. or a combination of these processes and/or products; substances necessary for their manufacture or for giving specific characteristics to the products may be added;

(l) "hermetically sealed container" means a container that is designed and intended to be secure against the entry of micro-organisms;

(m) "where necessary", "where appropriate", "sufficient" mean where revealed necessary, appropriate or sufficient after hazard analysis in the context of the HACCP system.

Article 3 General obligation

In addition to the general principles laid down in Regulation (EC) No 178/2002, food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the hygiene requirements laid down in this Regulation that are relevant to their activities.

Article 4 General hygiene requirements and specific hygiene requirements

1. Food business operators at the level of primary production shall comply with the general hygiene provisions in Annex I hereto, any other specific provisions in Regulation (EC) No .../... (laying down specific hygiene rules for food of animal origin), and in any other Annexes relevant to their activities which may be added to this Regulation in accordance with the procedure laid down in Article 13(2).

2. Food business operators, other than referred to in paragraph 1, shall comply with the general hygiene provisions in Annex II, any other specific provisions laid down in Regulation (EC) No .../... (laying down specific hygiene rules for food of animal origin) and in any other annexes relevant to their activity which may be added to this Regulation in accordance with the procedure laid down in Article 13(2).

3. Exemptions from provisions of the Annexes referred to in paragraphs 1 and 2 may be granted in accordance with the procedure laid down in Article 13(2), provided that such exemptions do not affect the achievement of the objectives of this Regulation.

4. A Member State may, in co-operation with the Commission and in accordance with the procedure referred to in paragraph 5, adapt the requirements laid down in Annexes I and II, provided that the objectives of food hygiene are not compromised, with a view to:

(a) accommodating the needs of food businesses situated in regions suffering from special geographical constraints or affected by supply difficulties which are serving the local market, or

(b) take account of traditional methods of production or the use of raw materials which are, according to scientific findings, established practice or tradition, characteristic of the production process.

5. Member States having recourse to the possibility referred to in paragraph 4 shall notify the Commission and the other Member States and supply them with a list of products and the regions concerned as well as the adjustments made to adapt hygiene rules. Member States may, within one month of the receipt of the notification, send written comments to the Commission. Where appropriate, a decision shall be taken in accordance with the procedure referred to in Article 13(2).

6. Food business operators shall:

(a) ensure that temperature criteria for foodstuffs are complied with and that the cold chain is maintained,

(b) ensure that microbiological criteria for foodstuffs are complied with,

(c) take measures or adopt procedures necessary to meet targets and performance standards set to achieve the objectives of this Regulation,

(d) use appropriate methods of sampling and analysis.

7. The criteria, targets, performance standards and methods referred to in paragraph 6 shall be adopted in accordance with the procedure referred to in Article 13(2).

8. Pending the setting of the criteria, targets, standards and methods referred to in paragraph 6, the relevant criteria, targets, standards and methods laid down in the Directives referred to in Articles 1 and 2 of Directive .../... (repealing certain Directives on the hygiene of foodstuffs and on the health conditions for the production and the placing on the market of certain products of animal origin, and amending Directives 89/662/EEC and 91/67/EEC), or their implementing rules, shall continue to apply, as shall national rules adopted in accordance with those Directives or their implementing rules.

Article 5 Hazard analysis and critical control points (HACCP) system

1. Food business operators other than at the level of primary production shall put in place, implement and maintain a permanent procedure based on the following principles of the HACCP system:

(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 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 actions when monitoring indicates that a critical control point is not under control.

2. Food business operators other than at the level of primary production shall establish procedures to verify whether the measures referred to in paragraph 1 are working effectively. Verification procedures shall be carried out regularly and whenever the food business operation changes in a manner that could adversely affect food safety.

3. In order to facilitate official controls, food business operators other than at the level of primary production shall provide evidence to the competent authority that they are complying with paragraphs 1 and 2. Where the nature and size of a food business so necessitates, such evidence shall include documentation. Such documentation shall be kept by the food business operator for at least the time of the shelf life of the product.

4. As part of the system referred to in paragraphs 1, 2 and 3, food business operators may, on a voluntary basis, use guides to good practice in conjunction with guides on the application of HACCP, as developed in accordance with Articles 6 and 7. Such guides must be appropriate for the operations and foods to which they are applied by the food business operator.

5. In accordance with the procedure referred to in Article 13(2), measures may be adopted in order to facilitate the implementation of this Article, in particular in small businesses.

Article 6 National guides to good practice and guides to the application of HACCP

1. Member States shall encourage the development of guides to good practice which shall include guidance on the compliance with Article 3, 4 and where Article 5 applies, the application of the principles of HACCP (hereinafter referred to as national guides).

2. Where national guides are developed, they shall be developed as follows:

- by food business sectors,

- in consultation with representatives of other interested parties, such as competent authorities and consumer groups whose interests are substantially affected,

- where appropriate, having regard to the Recommended International Codes of Practice of the Codex Alimentarius.

National guides may be developed under the aegis of a national standards institute referred to in Annex I to Directive 98/34/EC [9] of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations as amended by Directive 98/48/EC [10].

[9] OJ L 204, 21.7.1998, p. 37.

[10] OJ L 217, 5.8.1998, p. 18.

3. Member States shall assess national guides to ensure:

(a) that the contents of such guides are practicable for the sectors to which they refer,

(b) have been developed in consultation with representatives of the sector concerned and other interested parties, such as competent authorities and consumer groups,

(c) have been developed having regard to the Recommended International Code of Practice, General Principles of Food Hygiene, of the Codex Alimentarius,

(d) that all interested parties substantially affected have been consulted and the relevant comments taken into account,

(e) their suitability as guides to compliance with the provisions of Articles 3, 4, and 5 in the sectors and/or for the foodstuffs covered.

4. Twelve months following the entry into force of this Regulation, and thereafter annually, the Member States shall forward to the Commission a report concerning the steps taken to develop national guides specified in paragraph 1.

5. Member States shall forward to the Commission those national guides which they have determined to comply with paragraph 3. The Commission shall keep a register of such guides and make this available to the Member States.

6. The guides to good practice already developed and applied in accordance with Directive 93/43/EEC may continue to be used after the entry into force of this Regulation insofar as they are compatible with the objectives of this Regulation.

Article 7 Community guides

1. Where a Member State or the Commission considers that there is a need for uniform Community guides to good practice, and/or Community guides on the application of the principles of HACCP (hereinafter referred to as Community guides), the Commission shall consult the Committee referred to in Article 13(1). The objective of this consultation shall be to consider the case for such guides, their scope and subject matter.

2. Where, pursuant to paragraph 1, it is considered that there is a need for Community guides, they shall be developed:

(a) by representatives of the European sector concerned, including small and medium sized enterprises (SMEs),

(b) in consultation with other interested parties, such as competent authorities and consumer groups,

(c) taking into account the Recommended International Code of Practice, General Principles of Food Hygiene, of the Codex Alimentarius and any national guides developed in accordance with Article 6.

3. The Committee referred to in Article 13(1) shall be responsible for assessing Community guides with a view to ensuring:

(a) that the contents of such guides are practicable for the sectors to which they refer throughout the Community,

(b) that all interested parties substantially affected by such guides have been consulted, and the relevant comments taken into account,

(c) that, where they exist, national guides are forwarded to the Commission under Article 6(5) have been taken into account,

(d) they are suitable as guides to compliance with the provisions of Articles 3, 4, and 5 in the sectors and/or for the foodstuffs covered.

4. Where national guides have been produced in accordance with Article 6 and subsequently Community guides are produced in accordance with this Article, food business operators may refer to either.

5. The titles and references of Community guides shall be published in the C series of the Official Journal of the European Communities. Member States shall ensure that such published guides are drawn to the attention of the relevant food business sectors and the appropriate authorities in their territories.

Article 8 Registration or approval of Food Businesses

1. Food business operators shall notify all establishments under their control and covered by this Regulation to the Competent Authority/ies outlining the nature of the business, the name and address of all premises.

The Competent Authority/ies shall allocate a registration number to each food establishment and keep an up to date list thereof. They may use registrations already issued for other purposes.

Food business operators shall supply the competent authority with the information required, including all new food business activities, all new establishments and all closures of existing establishments, in order to keep the list of premises up to date.

2. Food business operators shall ensure that establishments under their control are approved by the competent authority when required:

(a) under the national law of the Member State in which the establishment is located;

(b) under Regulation (EC) No .../... [laying down specific hygiene rules for food of animal origin]; or

(c) by a measure adopted in accordance with the procedure referred to in Article 13(2).

3. If approval is required for an establishment pursuant to paragraph 2, a food business operator may not operate an establishment without this approval after an on-the-spot check of the establishment has shown that requirements relating to infrastructure and operations are complied with and all aspects of hygiene have been examined and found to comply with the relevant provisions of this Regulation.

Article 9 Official controls

Food business operators shall give all assistance needed to ensure that official controls carried out by the competent authority can be performed efficiently. They shall in particular:

- give access to all buildings, premises, installations or other infrastructures,

- make available any documentation and record required under the present Regulation or considered necessary by the competent authority for judging the situation.

Article 10 Imports / exports

For the purposes of Articles 11 and 12 of Regulation (EC) No 178/2002, the implementation by food business operators importing or exporting food respectively, of the hygiene requirements provided for in this Regulation shall be taken into account.

Article 11 Amending of annexes and implementing measures

1. Provisions in the Annexes to this Regulation may be amended in accordance with the procedure laid down in Article 13(2).

2. Implementing measures in relation to Articles 4, 5, 8 and 10 may be adopted in accordance with the procedure laid down in Article 13(2).

Article 12 References to international standards

Amendments to references to international standards contained in this Regulation, such as those of the Codex Alimentarius, may be adopted in accordance with the procedure referred to in Article 13(2).

Article 13 Standing Committee procedure

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, in compliance with Article 8 thereof.

3. The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 14 Report to Council and Parliament

The Member States shall submit to the Commission, within four years after the entry into force of this Regulation, reports on its operation.

On the basis of these reports, the Commission shall, within five years after the entry into force of this Regulation, review its operation and submit to the European Parliament and the Council a report, accompanied where necessary by legislative proposals.

Article 15 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.

It shall apply as from ....*

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ANNEX I

GENERAL HYGIENE RULES FOR PRIMARY PRODUCTION

CHAPTER I

Scope and requirements

I. SCOPE

This Annex applies to the production of primary products and includes associated operations such as the transport, storage and handling of primary products at the place of production.

II. GENERAL REQUIREMENTS

1. Food business operators must ensure, as far as possible, that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.

2. Notwithstanding the general duty laid down in paragraph 1, food business operators must comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production, including:

(a) measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection agents and biocides, and the storage, handling and disposal of waste, and

(b) measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents.

(c) the obligation to inform the competent authority if a problem that may affect human health is suspected.

III. REQUIREMENTS FOR PRODUCTS OF ANIMAL ORIGIN

Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin must take adequate measures, as appropriate:

(a) to keep any facilities used in connection with primary production, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner;

(b) to keep clean and, where necessary after cleaning, to disinfect in an appropriate manner equipment, containers, crates, vehicles and vessels;

(c) to ensure, as far as possible, the cleanliness of animals going to slaughter and, where necessary, production animals;

(d) to prevent, as far as possible, pests from causing contamination;

(e) to store and handle waste and hazardous substances so as to prevent contamination;

(f) to prevent the introduction and spread of contagious diseases transmissible to humans through food, including by taking precautionary measures when introducing new animals and reporting suspected outbreaks of such diseases to the competent authority;

(g) to take account of the results of any relevant analyses carried out on samples taken from animals or other samples that have importance to human health; and

(h) to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation.

IV. REQUIREMENTS FOR PRODUCTS OF PLANT ORIGIN

Food business operators producing or harvesting plant products must take adequate measures, as appropriate:

(a) to keep clean and, where necessary after cleaning, to disinfect in an appropriate manner facilities, equipment, containers, crates and vehicles [used with plant products];

(b) to ensure, where necessary, the cleanliness of plant products;

(c) to prevent, as far as possible, pests from causing contamination;

(d) to avoid biological, chemical and physical hazards such as mycotoxins, heavy metals etc.;

(e) to store and handle wastes and hazardous substances so as to prevent contamination; and

(f) to take account of the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.

CHAPTER II

Record keeping

1. Food business operators must keep records relating to measures taken to control food hazards.

2. Food business operators rearing animals or producing primary products of animal origin must, in particular, keep records on:

(a) the nature and origin of feed;

(b) veterinary products or other treatments administered to animals, dates of administration and withdrawal periods;

(c) the occurrence of diseases that may affect the safety of products of animal origin;

(d) the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance to human health; and

(e) any relevant reports on checks carried out on animals or products of animal origin.

When animals are taken to a slaughterhouse, relevant information from the records shall be communicated to the competent authorities and the receiving food business operator.

3. Food business operators producing or harvesting plant products must, in particular keep records on:

(a) the use of plant protection agents and herbicides;

(b) the occurrence of pests or diseases that may affect the safety of products of plant origin; and

(c) the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.

4. Food business operators must make relevant information from such records available on request to the competent authority and to receiving food business operators.

5. Other persons, such as veterinarians, agronomists and farm technicians, shall assist the food business operator with the keeping of records.

6. The records may be combined with or replaced by other records that may be required under Community or national law.

CHAPTER III

Guides to good practice

1. National and Community guides referred to in Articles 6 and 7 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production.

2. Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:

(a) the control of contamination such as mycotoxins, heavy metals and radioactive material;

(b) the use of water, organic waste and fertilisers;

(c) the correct and appropriate use of plant protection agents and their traceability;

(d) the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;

(e) the preparation, storage, use and traceability of feed;

(f) the proper disposal of dead animals, waste and litter;

(g) protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;

(h) procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;

(i) measures relating to the cleanliness of slaughter and production animals; and

(j) measures relating to record-keeping.

ANNEX II

GENERAL HYGIENE REQUIREMENTS APPLYING TO ALL FOOD BUSINESSES (EXCEPT PRIMARY PRODUCTION)

Introductory remarks

Chapters V to XII of this Annex apply throughout all stages after primary production during preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the final consumer.

The remaining Chapters of the Annex apply as follows:

- Chapter I to all food premises except those covered by Chapter III,

- Chapter II to all rooms where food is prepared, treated or processed except those covered by Chapter III and excluding dining areas,

- Chapter III to those premises listed in the heading to the Chapter,

- Chapter IV to all transportation.

CHAPTER I

General requirements for food premises including outside areas and sites (other than those specified in Chapter III)

1. Food premises must be kept clean and maintained in good repair and condition.

2. The layout, design, construction, siting and size of food premises shall:

(a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and have adequate working space to allow for the hygienic performance of all operations;

(b) be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces;

(c) permit good food hygiene practices, including protection against contamination between and during separate operations from foodstuffs, wrapping and packaging materials, equipment, materials, water, air supply or personnel and external sources of contamination such as pests;

(d) Where it is necessary for the purposes of achieving the objectives of this Regulation, provide suitable temperature-controlled storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and recorded.

3. An adequate number of washbasins must be available, suitably located and designated for cleaning hands. An adequate number of flush lavatories must be available and connected to an effective drainage system. Lavatories must not open directly into rooms in which food is handled.

4 Washbasins for cleaning hands must be provided with hot and cold running water, materials for cleaning hands and for their hygienic drying. Where necessary to avoid an unacceptable risk of contamination of food, the facilities for washing food must be separate from the hand-washing facility.

5. There must be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area must be avoided. Ventilation systems must be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible.

6. Sanitary conveniences shall be provided with adequate natural or mechanical ventilation.

7. Food premises must have adequate natural and/or artificial lighting.

8. Drainage facilities must be adequate for the purpose intended; they must be designed and constructed to avoid the risk of contamination of foodstuffs. Where drainage channels are fully or partially open, they must be so designed to ensure that waste does not flow from a contaminated area towards and into a clean area or area where foods likely to present a high risk to the final consumer are handled.

9. Where and as necessary, adequate changing facilities for personnel must be provided.

10. Cleaning agents and disinfectants must not be stored in areas where food is handled.

CHAPTER II

Specific requirements in rooms where foodstuffs are prepared, treated or processed (excluding dining areas and those premises specified in Chapter III)

1. In rooms where food is prepared, treated or processed (excluding dining areas and those premises specified in Chapter III but including compartments in vehicles) the design and layout shall permit good food hygiene practices, including protection against cross-contamination between and during operations, and in particular:

(a) floor surfaces must be maintained in a sound condition and be easy to clean and, if necessary, disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate. Where appropriate, floors must allow adequate surface drainage;

(b) wall surfaces must be maintained in a sound condition and be easy to clean and, if necessary, disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the competent authority that other materials used are appropriate;

(c) ceilings, overhead structures and the inner surfaces of roofs must be constructed to prevent the accumulation of dirt and reduce condensation, the growth of undesirable moulds and the shedding of particles;

(d) windows and other openings must be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment must where necessary be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination of foodstuffs, windows must remain closed and fixed during production;

(e) doors must be easy to clean and, where necessary, disinfect. This will require the use of smooth and non-absorbent surfaces unless food business operators can satisfy the competent authority that other materials used are appropriate;

(f) surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food must be maintained in a sound condition and be easy to clean and, if necessary, disinfect. This will require the use of corrosion resistant, smooth, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate.

2. Adequate facilities must be provided for the cleaning and disinfecting of working utensils and equipment where this is required for the purposes of achieving the objectives of this Regulation. These facilities must be constructed of materials resistant to corrosion and must be easy to clean and have an adequate supply of hot and cold water.

3. Adequate provision must be made for any necessary washing of food where this is required to achieve the objectives of this Regulation. Every sink or other such facility provided for the washing of food must have an adequate supply of hot and/or cold potable water as required and be kept clean and, where necessary, disinfected.

CHAPTER III

Requirements for movable and/or temporary premises (such as marquees, market stalls, mobile sales vehicles), premises used primarily as a private dwelling house but where foods are prepared for purposes other than private and domestic consumption, premises used occasionally for catering purposes, and vending machines

1. Premises and vending machines shall be so sited, designed, constructed and kept clean and maintained in good repair and condition as to avoid the risk of contamination of foodstuffs, in particular by animals and pests, so far as is reasonably practicable.

2. In particular and where necessary:

(a) appropriate facilities must be available to maintain adequate personal hygiene (including facilities for the hygienic washing and drying of hands, hygienic sanitary arrangements and changing facilities);

(b) surfaces in contact with food must be in a sound condition and be easy to clean and, if necessary, disinfect. This will require the use of corrosion resistant, smooth, washable, non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate;

(c) adequate provision must be made for the cleaning and, if necessary, disinfecting of working utensils and equipment;

(d) where foodstuffs are cleaned as part of the food business's operations adequate provision must be made for this to be undertaken hygienically;

(e) an adequate supply of hot and/or cold potable water must be available;

(f) adequate arrangements and/or facilities for the hygienic storage and disposal of hazardous and/or inedible substances and waste (whether liquid or solid) must be available;

(g) adequate facilities and/or arrangements for maintaining and monitoring suitable food temperature conditions must be available;

(h) foodstuffs must be so placed as to avoid the risk of contamination so far as is reasonably practicable.

CHAPTER IV

Transport

1. Conveyances and/or containers used for transporting foodstuffs must be kept clean and maintained in good repair and condition in order to protect foodstuffs from contamination and must, where necessary, be designed and constructed to permit adequate cleaning and/or disinfection.

2. Receptacles in vehicles and/or containers must not be used for transporting anything other than foodstuffs where this may result in contamination of foodstuffs.

3. Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there must be an effective cleaning between loads to avoid the risk of contamination.

4. Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there must be effective separation of products to protect against the risk of contamination.

5. Bulk foodstuffs in liquid, granular or powder form must be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such containers must be marked in a clearly visible and indelible fashion, in one or more Community languages, to show that they are used for the transport of foodstuffs, or must be marked "for foodstuffs only".

6. Foodstuffs in conveyances and/or containers must be so placed and protected as to minimise the risk of contamination.

7. Where it is necessary for the purposes of achieving the objectives of this Regulation, conveyances and/or containers used for transporting foodstuffs must be capable of maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored.

CHAPTER V

Equipment requirements

All articles, fittings and equipment with which food comes into contact shall be kept clean and:

(a) be so constructed, be of such materials and be kept in such good order, repair and condition as to avoid any risk of contamination of the food;

(b) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept thoroughly cleaned and, if necessary, disinfected, sufficient for the purposes intended;

(c) be installed in such a manner as to allow adequate cleaning of the surrounding area.

CHAPTER VI

Food waste

1. Food waste, non-edible by-products and other refuse must be removed from rooms where food is present as quickly as possible so as to avoid its accumulation and to prevent the contamination of food.

2. Food waste, non-edible by-products and other refuse must be deposited in closable containers unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers must be of an appropriate construction, kept in sound condition, be easy to clean and if necessary disinfect.

3. Adequate provision must be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores must be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests.

4. All waste, whether liquid, solid or gaseous, must be disposed of in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and must not constitute a source of contamination of the food, either directly or indirectly.

CHAPTER VII

Water supply

1. There must be an adequate supply of potable water as specified in Council Directive 98/83/EC relating to the quality of water intended for human consumption [11]. This potable water must be used whenever necessary to ensure that foodstuffs are not contaminated.

[11] OJ L 330, 5.12.1998, p. 32.

2. Water which is recycled either to be used in processing or as an ingredient must not present a risk of contamination to the food from microbiological, chemical or physical hazards, and shall be of the same standard as potable water under Directive 98/83/EC, unless the competent authorities in the Member States are satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form.

3. Ice which comes into contact with food or which may lead to any contamination of food must be made from water which meets the specifications referred to in Directive 98/83/EC. It must be made, handled and stored under conditions which protect it from all contamination.

4. Steam used directly in contact with food must not contain any substance which presents a hazard to health or is likely to contaminate the food.

5. Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it must circulate in a separate system and be identified as such. Non-potable water shall not connect with, or allow reflux into, potable water systems.

6. Where heat treatment is applied to foodstuffs in hermetically sealed containers, it must be ensured that the water used for heating the containers or for cooling them after heat treatment is not a source of contamination for the foodstuffs.

CHAPTER VIII

Personal hygiene

1. Every person working in a food-handling area shall maintain a high degree of personal cleanliness and shall wear suitable, clean and, where necessary for the purposes of achieving the objectives of this Regulation, protective clothing.

2. No person suffering from, or known to be a carrier of a disease likely to be transmitted through food or while afflicted for example with infected wounds, skin infections, sores or diarrhoea shall be permitted to enter any food-handling area in any capacity if there is any likelihood of directly or indirectly contaminating food with pathogenic micro-organisms. Any person so affected and employed in a food business and who is likely to come into contact with food shall immediately report illness or symptoms to the food business operator.

CHAPTER IX

Provisions applicable to foodstuffs

1. No raw materials or ingredients shall be accepted by a food business if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic micro-organisms or toxic, decomposed or foreign substances that, after normal sorting and/or preparatory or processing procedures hygienically applied by food businesses, they would still be unfit for human consumption.

2. Raw materials and all ingredients stored in a food business shall be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination.

3. All food which is handled, stored, packaged, displayed and transported must be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state. Adequate procedures must be in place to ensure pests are controlled.

4. Raw materials, ingredients, intermediate products and finished products likely to support the development of pathogenic micro-organisms or the formation of toxins must be kept at temperatures which would not result in a risk to health. The cold chain must not be interrupted. However, limited periods outside temperature control are permitted to accommodate the practicalities of handling during preparation, transport, storage, display and service of food provided that it does not result in a risk to health. For processed foodstuffs food businesses manufacturing, handling and wrapping processed foodstuffs must have suitable rooms large enough for the separate storage of raw materials from processed material, with sufficient separate refrigerated storage to prevent contamination.

5. Where foodstuffs are to be held or served at chilled temperatures they must be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which would not result in a risk to health.

6. The thawing of foodstuffs shall be undertaken in such a way as to minimise the risk of development of pathogenic micro-organisms or the formation of toxins in the foods. During thawing foods shall be subjected to temperatures which would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it must be adequately drained. Following thawing, food must be handled in such a manner as to minimise the risk of development of pathogenic micro-organisms or the formation of toxins.

7. Hazardous and/or inedible substances, including animal feedstuffs, shall be adequately labelled and stored in separate and secure containers.

8. Raw materials used for the manufacture of processed products must have been produced and marketed or imported in accordance with this Regulation.

CHAPTER X

Provisions applicable to the wrapping and packaging of foodstuffs

1. Measures shall be taken to ensure that wrapping and packaging materials are not a source of contamination to foodstuffs. Wrapping and packaging materials must be manufactured transported and supplied to food businesses in such a manner that they are protected from any contamination that may present a risk to health.

2. Wrapping materials must be stored in such a manner that they are not exposed to a risk of contamination which might be detrimental to food safety.

3. Wrapping and packing operations must be carried out so as to avoid contamination of food. In particular, the room where packaging operations are undertaken must be of sufficient size, construction and design to allow for hygienic operations. Packaging materials must be clean prior to being brought into the packaging area and used without delay. Where packaging materials are to be lined with a wrapping material this must be carried out hygienically.

4. Wrapping and packaging material must only be re-used for foodstuffs if it is made of materials that are easy to clean and where necessary for the purposes of food hygiene, to disinfect.

CHAPTER XI

Special conditions for certain processing operations

1. Processing by heat treatment

- The food must be processed in accordance with a scheduled heat treatment possibly associated with other methods to control microbiological hazards; equipment for the heat-treatment must be fitted with all control devices necessary to ensure that an appropriate heat treatment is applied.

- If the heat treatment, possibly combined with other hurdles is not sufficient to ensure the stability of the products, a rapid cooling to the specified storage temperature must be applied after heating so that the critical temperature zone for spore germination and subsequent growth is passed through as rapidly as possible.

- If the heat treatment is applied before wrapping, measures must be taken to prevent recontamination of the food after heating and before filling.

- Where appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its cleanliness must be confirmed before filling.

- Where the heat treatment is applied to foodstuffs in hermetically sealed containers it must be ensured that the water used for cooling the containers after heat treatment is not a source of contamination for the foodstuff. Chemical additives to prevent corrosion of equipment and containers must be used in accordance with good practices.

- In the case of a continuous heat treatment of liquid food, the mixture of heat-treated liquid with incompletely heated liquid must be adequately prevented.

2. Smoking

- Fumes and heat must not affect other operations.

- Materials used for smoke production must be stored and used in such a way as to avoid contamination of foodstuffs.

- The combustion for smoke production of wood which is painted, varnished, glued or has undergone any chemical preservation is prohibited.

3. Salting

Salts used for the treatment of foodstuffs must be clean and must be stored in such a way as to prevent contamination. Salts may be re-used after cleaning where HACCP procedures have demonstrated that there is no risk of contamination.

CHAPTER XII

Training

Food business operators shall ensure that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity.

Food business operators shall ensure that those responsible for the development and maintenance of the HACCP system or for the introduction of the guides referred to in Article 6 and 7 of the present Regulation in a food business have received adequate training in the principles of HACCP and the areas covered by the guides.