Regulations (EC) No 852/2004, No 853/2004 and No 854/2004 contain the legal requirement for the Commission to submit a report to the European Parliament and to the Council, reviewing the experience gained from their application and, if appropriate, accompanying the report with relevant proposals, not later than 20 May 2009. In addition, Regulation (EC) No 852/2004 requires the Commission to consider if it is desirable and practicable to extend the Hazard Analysis Critical Control Point (HACCP) requirements to food business operators in the primary production area.

This report followed a thorough consultation process. It is based on information received from the competent authorities in the Member States, representatives of the food business operator and consumer organisations at European level, and the Commission's Food and Veterinary Office.

Conclusion : the report aims at presenting factually the experience gained, including the difficulties encountered, in 2006, 2007 and 2008 from the implementation of the hygiene package by all interested actors. It concludes that overall Member States have taken the necessary administrative and control steps to ensure compliance but that there is still room for improvement in relation to implementation. These conclusions are supported by the findings of audits and inspections carried out by the Commission's Food and Veterinary Office. Consulted stakeholders consider that the new principles and requirements introduced by the hygiene package have had a positive impact. It also indicates the clear position expressed by the Member States and private stakeholders not to extend at present the requirement for HACCP-based procedures to food business operators carrying out primary production.

The main difficulties identified are in relation to: (i) certain exemptions from the scope of the hygiene Regulations; (ii) certain definitions laid down in the Regulations and the procedure for adapting those definitions; (iii) certain practical aspects concerning the approval of establishments handling foods of animal origin and the marking of such foods; (iv) the import regime for certain foods; (v) the implementation of HACCP-based procedures in certain food businesses; and (vi) the implementation of official controls in certain sectors.

This report does not suggest any detailed solutions to the difficulties reported and is, therefore, not accompanied by proposals. However, on the basis of the difficulties identified, the Commission will consider the need for any proposals to improve the food hygiene package.

EUR-Lex
COM(2009)0403

EUR-Lex
SEC(2009)1079

ACT : Commission Regulation 2073/2005/EC on microbiological criteria for foodstuffs.

CONTENT : in order to contribute to the protection of public health and to prevent differing interpretations, it is appropriate to establish harmonised safety criteria on the acceptability of food, in particular as regards the presence of certain pathogenic micro-organisms.

Microbiological criteria also give guidance on the acceptability of foodstuffs and their manufacturing, handling and distribution processes. The use of microbiological criteria should form an integral part of the implementation of HACCP-based procedures and other hygiene control measures.

This Regulation lays down the microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when implementing the general and specific hygiene measures referred to in Article 4 of Regulation 852/2004/EC. The competent authority shall verify compliance with the rules and criteria laid down in this Regulation in accordance with Regulation 882/2004/EC, without prejudice to its right to undertake further sampling and analyses for the purpose of detecting and measuring other micro-organisms, their toxins or metabolites, either as a verification of processes, for food suspected of being unsafe, or in the context of a risk analysis.

This Regulation shall apply without prejudice to other specific rules for the control of micro-organisms laid down in Community legislation and in particular the health standards for foodstuffs laid down in Regulation 853/2004/EC of the European Parliament and of the Council, the rules on parasites laid down under Regulation 854/2004/EC of the European Parliament and of the Council and the microbiological criteria laid down under Council Directive 80/777/EEC.

This Regulation shall be reviewed taking into account progress in science, technology and methodology, emerging pathogenic micro-organisms in foodstuffs, and information from risk assessments. In particular, the criteria and conditions concerning the presence of salmonella in carcases of cattle, sheep, goats, horses, pigs and poultry shall be revised in the light of the changes observed in salmonella prevalence.

ENTRY INTO FORCE : 11/01/2006. It shall apply from 01/01/2006.

32005R2073
OJ L 338 22.12.2005, p. 0001-0026

PURPOSE : to lay down general rules for food business operators on the hygiene of foodstuffs.

LEGISLATIVE ACT : Regulation 852/2004/EC of the European Parliament and of the Council on the hygiene of foodstuffs. (Corrigendum to the Regulation published in OJ L139 of 30 April 2004).

CONTENT : this Regulation imposes a requirement on food business operators to ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.

The Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

- primary responsibility for food safety rests with the food business operator; - it is necessary to ensure food safety throughout the food chain, starting with primary production; - it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;

- general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility. Food safety is a result of several factors. This legislation lays down minimum hygiene Requirements. It also states that official controls should be in place to check food business operators' compliance and food business operators must operate food safety programmes and procedures based on the HACCP principles. This only applies to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I. The HACCP principles consist of the following:

- identifying any hazards that must be prevented, eliminated or reduced to acceptable levels; - identifying the critical control points at the steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;

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

- implementing effective monitoring procedures at critical control points;

- establishing corrective actions when monitoring indicates that a critical control point is not under control; - establishing procedures to verify that the measures outlined above are working effectively; and - establishing documents commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined above. Member States must encourage the development of national guides to good practice for hygiene and for the application of HACCP principles. Community guides will be developed. The dissemination of both national and Community guides will be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis.

Every food business operator must notify the appropriate competent authority of each establishment under its control that carries out any of the stages of production, processing and distribution of food, so that each such establishment might be registered. Operators must ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required by national or Community law. Food imported and exported is to comply with the general requirements laid down in Regulation 178/2002 or satisfy rules that are equivalent to Community rules. This Regulation defines certain specific hygiene requirements for imported and exported food. This Regulation replaces Directive 93/43/EEC, which is repealed.

ENTRY INTO FORCE : 20/05/2004. The Regulation shall apply no earlier than 01/01/2006.

Regulation 2004/852
OJ L 226 25.06.2004, p. 0001-0002

COM(2004)0340
EUR-Lex

T5-0216/2004
OJ C 103 29.04.2004, p. 0034-0241 E

Debate in Parliament

T5-0216/2004

A5-0131/2004

A5-0131/2004

SEC(2003)1450
EUR-Lex

10543/2/2002
OJ C 048 24.02.2004, p. 0001-0022 E

10543/2/2002

12133/2003

COM(2003)0033
EUR-Lex

COM(2003)0033
EUR-Lex

2426

T5-0234/2002
OJ C 180 31.07.2003, p. 0160-0267 E

T5-0234/2002

Debate in Parliament

A5-0129/2002

A5-0129/2002

2402

2348

CES0405/2001
OJ C 155 29.05.2001, p. 0039

2289

EUR-Lex
COM(2000)0438

EUR-Lex
COM(2000)0438