POSITIONS

IDACE proposal for the harmonisation of the national legislation in the EU Member States on the microbiological criteria for foodstuffs intended for infants and young children in good health as defined in Directives 91/321/EEC as amended and 95/5/EC as amended.

1. Introduction

Several European directives regulate foods for infants and young children in good health. Although none of them contain microbiological criteria, they all have provisions included allowing possible introduction at a future date. These directives also provide for procedures to be followed when establishing these criteria:

¨ In article 6 of both the Directive on Infant Formulae and Follow-on Formulae (91/321/EEC) as amended and the Directive on Processed Cereal-based Foods and Baby Foods for Infants and Young Children (96/5/EC) as amended.

¨ In article 4.1.c. of the directive on the approximation of the 1aws of the Member States relating to Foodstuffs for Particular Nutritional Uses (89/398/EEC).

¨ In article 4 of the Directive for the Hygienic Production of Food (93/43/EEC).

The characteristics and sensitivity of this group of consumers who are in such an early stage of life justify the development of specific microbiological criteria for the products consumed by them.

This IDACE document presents a proposal for microbiological criteria for products for infants and young children. It includes information on the approach taken when establishing the proposal as well as the relevant principles that have been considered in the process.

It can be used in discussions with the EU Commission as an IDACE proposal on this subject and be given as information to the international authorities so that they are aware of branch activities for consideration in their official policy.

This IDACE proposal has taken into consideration:

¨ The application of hygienic practices, such as the establishment of guides of hygienic practice at national or European level, both based on article 5 of Directive 93/43/EEC.

¨ That the microbiological safety of the products is not ensured by the sole analysis of final products.

¨ That manufacturers run their operations applying appropriate preventive measures to ensure the safety of their products, i.e. following the principles of an HACCP type approach as formulated in article 3 of Directive 93/43/EEC.

¨ That microbiological criteria represent for authorities a tool to verify the performance of the preventive measures taken and that for the industry they represent a target to achieve in order to guarantee the safety of a product.

2. Relevant documents

A proposal for microbiological criteria for the products covered should be based on EU legislation as the terms of reference. The following documents may be used for guidance. In view of the impact of Codex in international trade, particular attention should be given to the Codex documents.

1. Directive for the Hygienic Production of Food (93/43/EEC).

2. Directive for Food for Particular Nutritional Uses (89/398/EEC), article 4.1 c.

3. Directive for Infant Formulae and Follow-on Formulae (91/321/EEC), article 6.

4. Directive on Processed Cereal-Based Foods and Baby Foods for Infants and Young Children (96/5/EC), article 6.

5. Directive for laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products (92/46/EEC) and its amendments.

6. Directive for changing and updating Directive 77/99/EEC on questions of health for the intracommunity trade in meat products (92/5/EEC) and its amendments.

7. Directive for laying down the health conditions for the production and the placing on the market of fishery products (91/493/EEC) and its amendments.

8. Codex Alimentarius, Recommended International Code of Practice – General Principles of Food Hygiene (CAC/RCP 1-1969, Rev 3 (1997), Supplement to volume 1B, Rome, 1997).

9. Codex Alimentarius Code of Hygienic Practice for Foods for Infants and Young Children (CAC/RCP 21-1979).

10. Codex Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL21-1997)

11. Hazard Analysis and Critical Control Point (HACCP) system and Guidelines for its Application, Annex to CAC/RCP 1-1969, Rev 3 (1997), Supplement to volume 1B, Rome, 1997)

12. Document (VI/8972/93) titled “Concept of milk-based products Directive 92/46/EEC laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products.”

13. Document VI/1030/93 on sanitary health rules for products covered by art 18 of directive 92/46/EEC.

14. For details on B. cereus see International Commission on Microbiological Specifications for Foods (ICMSF), Micro-organisms in Foods, Vol2 (1986), 226-233.

15. Directive on the Official Control of Foodstuffs (89/397/EEC).

3. Product categories

The products considered in this document are shelf-stable and traded under non-refrigerated conditions. Proposals for other products (e.g. refrigerated, frozen) can be added at later stages when relevant. Products considered may be or may contain ingredients of animal and/or vegetable origin. EU legislation defines the following categories.

Infant formulae: means foodstuffs intended for particular nutritional use by infants in good health during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons.

Follow-on formulae: means foodstuffs intended for particular nutritional use by infants in good health aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons.

Cereal based foods: means processed cereal based products (simple cereals, cereals with added high protein food, pastas, rusks and biscuits) intended for infants and young children in good health while they are being weaned and by young children for their progressive adaptation to ordinary food.

Baby foods: means processed food, excluding processed cereal based food, intended for infants and young children in good health while they are being weaned and by young children for their progressive adaptation to ordinary food.

The IDACE proposal, however, is based on the table in article 8.3 of the CODEX Code of Hygienic Practice for Foods for Infants and Young Children (see reference 9). The categorisation of products in this Codex text considers the final form of the food (liquid/solid) and the type of production process, and in particular the heat treatment the product receives before its use by the consumer. From the microbiological point of view this categorisation is more relevant than a system based on the categories defined in EU legislation.

Codex specifications classify products for infants and young children into four categories:

¨ Dried biscuit type products;

¨ Dried and instant products, boiling is not required;

¨ Dried products, that must be prepared following manufacturer’s instruction and boiled before consumption;

¨ Thermally processed products packaged in hermetically sealed containers.

Note on fourth category

For practical reasons, the group of products covered in this document by the term “thermally processed products packaged in hermetically sealed containers ” relates to products that can be transported and stored at ambient temperatures during their shelf life. This includes products that have been :

· Sufficiently heat-treated in the same container in which they are filled after processing.

· Aseptically filled after an UHT treatment.

This is relevant as the present legal definition of “hermetically sealed containers” (see art. 2.15 of Directive 92/46/EEC – reference 5) applies only to products included in the first category. Examples are sterilised liquid infant formulae and a complete meal in a jar. It does not include aseptically filled products.

This IDACE document, however includes both sterilised and aseptically filled products in the category of “thermally processed products packaged in hermetically sealed containers” in order to formulate a proposal for a common set of microbiological criteria.

The proposed criteria exclude products which must be kept refrigerated during their whole shelf life like a non-acidic products, pasteurised in the container. However, the criteria can be applied to e.g. acidic products that did not receive a heat-treatment equal to sterilisation but use their high acidity as an additional measure (or so called hurdle) to enable their transport and storage at ambient conditions during their shelf life.

4. Underlying preventive measures and position of products in hygiene legislation

The prerequisite for the production of safe products that comply with the standards defined by the authorities is the application of Good Hygiene Practices together with the use of a HACCP system approach.

Also during the discussions within CIAA and contacts with DGIII and DGVI, it became clear that any agreement must be based on:

¨ Internationally recognised principles for hygienic production of foodstuffs.

¨ Hazard Analysis and Critical Control Point system (HACCP), a system which identifies, evaluates and controls hazards that are significant for food safety (see reference 11).

HACCP applies to hazards, which can be biological, chemical or physical. A quality assurance system that introduces a HACCP approach is an efficient way to manage and ensure the safety of a product. The Directive on the Official Control of Foodstuffs 89/397/EEC (reference 15) prescribes that the control of the production of food by the competent authorities has to include the quality assurance system put in place by the producer as well as results obtained with such a system. This principle has been retained in the respective directives for the hygienic production of foodstuffs as well as in the ongoing review of this legislation.

Any proposed guide of hygienic practice should refer to internationally accepted principles. The legal position of guides of hygienic practices in the EU has been laid down in article 5 of Directive 93/43/EEC. These guides shall be developed by industry at national or European level with the participation of other interested parties (authorities, consumers). The directive does not contain a reference to professional agreements, present in its one of its early drafts.

The Directive for the Hygienic Production of Food (93/43/EEC) applies to all products that are not covered by so-called vertical legislation in which the legal requirements for specific product categories have been laid down. This vertical legislation covers many products of animal origin.

IDACE acknowledges that almost all products for infants and young children fall within the scope of specific vertical directives. These products have to satisfy the specific criteria contained therein. It is self-explaining, that raw materials used should also satisfy relevant legislation (raw meat, milk). However, the specific place of the processed foodstuffs covered by this text warrants the development of specific and separate legislation for the final products.

¨ The EEC Commission has adopted document VI/8972/93 entitled “Concept of milk-based products”, (reference 12). This document clarifies the definition of milk-based products (e.g. milk dessert, yogurt, milk powder).

¨ When dairy components constitute the main ingredient of the product, as defined in references 12 and 13, factories have, for the hygiene of their processes, to follow Directive 92/46/EEC.

¨ By exception, the EEC Commission also clarified in its document VI/1030/93 (reference 13) the position of milk products in which milk components have been replaced by non-dairy ingredients. The products containing milk ingredients, included in Directive 91/321/EEC, fall in this category. The hygienic conditions for production lines defined in 92/46/EEC are applicable. Exemptions apply from other obligations contained in this directive.

¨ Products containing meat or fish should satisfy the requirements of Directive 92/5/EEC (reference 6) and of Directive 91/493 EEC (reference 7) respectively.

5. Establishment and application of microbiological criteria

For establishing microbiological criteria, it is important to define certain principles on which proposals should be based. The principles to be applied for the establishment of microbiological criteria are outlined in the Codex document “General Principles for the Establishment and Application of Microbiological Criteria for Foods”, see reference 10.

Microbiological criteria define the acceptability of a product and should be based on the needs (e.g. epidemiological evidence of a public health concern) and the applicability (utility and benefits). They should be established on the basis of scientific knowledge and include aspects such as the microbiological status of raw materials, the effect of processing, the intended use of the food, the category of consumers and the cost/benefit ratio associated with their application.

Authorities can use microbiological standards for control purposes of commercialised products, thus as a measure of product acceptability. They have to include limits and sampling plans as well as the reference method.

In addition, the microbiological standards (limits, sampling plans, reference methods) applying to a specific product should be used in case of a dispute or in case of legal actions between producer and consumer, authorities, importer and exporter.

Microbiological criteria can be subdivided into three categories:

e1 Compulsory criteria for micro-organisms with a health risk

Criteria for specific pathogenic micro-organisms are necessary when their presence is considered to be a risk for the health of the consumer. These criteria are mandatory.

Actions in case of deviation: A batch has to be rejected, when it is confirmed that it contains numbers of pathogenic micro-organisms outside the limit values. Causes should be investigated and when their presence has been confirmed, a recall should be made.

e2 Analytical criteria indicating a lack of hygiene in production

Criteria for enterotoxigenic micro-organisms (e.g. S. aureus) define levels after manufacture that are indicators for poor hygiene in production. These organisms may form toxins when multiplying in out-of-control situations.

Actions in case of deviations: When limits for these micro-organisms are exceeded there must be a complete review of the implementation of the preventive measures and critical control points that have been identified and are applied in the processing establishment. A recall may be necessary, depending on the circumstances and also considering the legal requirements.

e3 Criteria for indicator organisms, essentially used by producers to confirm hygiene in production

Guideline levels for indicator organisms are mainly used by manufacturers for monitoring and confirming the proper functioning of their operations. The criteria can be included in their system and procedures to control production.

Actions in case of deviations: When the values under e3 are exceeded, the rejection of the product is normally not necessary, unless results indicate a loss of control that could result into a risk to consumer safety. However, the competent authorities may use the results obtained to evaluate the proper operation of hygienic factory management.

While criteria on pathogens (e1) are compulsory, criteria under e2 and e3 may also appear in legislation provided that their specific purpose and use are clearly indicated therein.

All responsible participants in the food chain must make sure that the products are in conformity with the legislation in force. In order to ensure microbiological safety, the producer or distributor of food products has to take all necessary measures so that the food is produced, treated, packaged, stored and distributed in such a way that unacceptable contamination and/or multiplication of a contaminating micro-organism is prevented.

However, this does not mean that each lot must be analysed for the parameters mentioned in the microbiological criteria. The microbiological examination alone of the product as sold is not sufficient to ensure its safety.

In the frame of the preventive systems put in place, manufacturers will therefore establish monitoring procedures encompassing the whole production chain, from the raw materials to the final product, including sampling at critical points of the processing lines and environment. Analyses of finished products are included in this concept and are used to verify the efficiency of the systems and compliance to legal requirements.