Considerations on COM(2000)438-1 - Hygiene of foodstuffs

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dossier COM(2000)438-1 - Hygiene of foodstuffs.
document COM(2000)438 EN
date April 29, 2004
 
(1) The protection of human health is of paramount importance.

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

(3) This Directive fixes the principles with regard to food hygiene 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 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 food safety.

(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 ensured that barriers to trade for the products concerned were removed, thus contributing to the creation of the internal market, whilst ensuring a high level of protection of public health.

(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, etc...

(9) Many of these principles are the same as the principles laid down in Council 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 food, 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. The specific hygiene rules for products of animal origin are contained in European Parliament and Council Regulation .... laying down specific hygiene rules for food of animal origin  i.

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

- The principle that primary responsibility for food safety rests with the manufacturer,

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

- maintaining the cold chain for food that cannot safely be stored at ambient temperatures,

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

- that codes to good practice are a valuable instrument for guiding 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 foods are of at least the same or an equivalent health standard;

(13) Food safety 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 food safety is not compromised.

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

(15) 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.

(16) 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 Hazard Analysis Critical Control System (HACCP).

(17) The hazard analysis critical control point system in food production 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.

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

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

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

(21) The traceability of food and food ingredients along the food chain is an essential element in ensuring food safety.

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

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

(24) Food imported into the Community shall be of the same hygiene level as the food obtained in the Community, or be of level equivalent thereto.

(25) In order to ensure a high level of protection and to prevent deflections of trade, food obtained in the Community and exported towards third countries shall not be of a lesser hygiene standard than the food produced and consumed within the Community.

(26) Scientific advice must underpin Community legislation on food hygiene; to this end, the scientific committees in the field of consumer protection and food safety set up by Commission Decision 97/579/EC of 23 July 1997  i and the Scientific Steering Committee set up by Commission Decision 97/404/EC of 10 June 1997  i 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 recast of existing Community hygiene rules means that the existing hygiene rules can be repealed; this is achieved through 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  i;

(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  i, they should be adopted by use of the regulatory procedure provided for in Article 5 of that Decision.