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.

This proposal for a Council Regulation concerns the implementation of Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the use of antimicrobial substances to remove surface contamination from poultry carcases.

Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. It provides that food business operators are not to use any substance other than water to remove surface contamination from products of animal origin, unless the use of the substance has been approved in accordance with that Regulation. It provides that the use of approved substances is not to affect the obligations of food business operators to comply with the requirements of that Regulation.

- In October 1998 and April 2003 , different scientific opinions were issued by the Scientific Committee on Veterinary measures relating to Public Heath (SCVPH) and concluded that the use of antimicrobial substances can contribute to the decrease of pathogens in the poultry provided those substances are used in the framework of an integrated control system of the food chain. In the framework of the EC-USA Veterinary Agreement, the USA submitted files concerning the use of four antimicrobial substances (chlorine dioxide, acidified sodium chlorite, trisodium phosphate and peroxyacids) on poultry carcases. These files were transmitted to the European Food Safety Authority (EFSA), which adopted an opinion in December 2005. EFSA concluded that the use of these substances in the described conditions does not present any risk to public health and that the use of antimicrobial solutions does not replace the need for good hygienic practices during processing of poultry carcases, particularly during handling. In a second opinion in December 2005, EFSA nevertheless pointed out that the information provided on peroxyacids indicated limited effectiveness, requiring specific conditions of use to be defined.

- On 6 March 2008 , EFSA in its scientific opinion on the Assessment of the possible effect of the four antimicrobial treatment substances on the emergence of antimicrobial resistance concludes that there are currently no published data to conclude in whatever way on the occurrence of acquired reduced susceptibility to these substances when applied on poultry carcases and to resistance to therapeutic antimicrobials.

- Lastly, on 31 March 2008 , the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and the Scientific Committee on Health and Environmental Risks (SCHER) in their joint opinion on environmental impact and effect on antimicrobial resistance of the four substances used for the removal of microbial surface contamination of poultry carcases conclude that there is not enough information available for producing comprehensive quantitative assessments that there is an environmental concern about the possibility to disseminate or select more resistant strains and, finally, that a low environmental risk has been estimated in relation to the potential residues in the carcases.

Against this background, a draft Commission Regulation approving the use of four substances to remove surface contamination from poultry carcases and setting down the conditions under which the substances may be used was submitted to the Standing Committee of the Food Chain and Animal Health, on 2 June 2008, for vote. The Committee delivered an opinion against the proposal: 26 Member States voted against and one Member State abstained.

Consequently, pursuant to Article 3(2) of Regulation (EC) No 853/2004 and in accordance with Article 5 of Council Decision 1999/468/EC modified by Council Decision 2006/512/EC, the Commission is submitting to the Council a proposal relating to the measures to be taken, the Council having three months in which to act by a qualified majority, and is informing the Parliament.

ACT : Commission Regulation 2074/2005/EC laying down implementing measures for certain products under Regulation 853/2004/EC of the European Parliament and of the Council and for the organisation of official controls under Regulation 854/2004/EC of the European Parliament and of the Council and Regulation 882/2004/EC of the European Parliament and of the Council, derogating from Regulation 852/2004/EC of the European Parliament and of the Council and amending Regulations 853/2004/EC and 854/2004/EC.

CONTENT :

- Regulation 853/2004/EC lays down specific requirements concerning hygiene rules for food of animal origin. It is necessary to lay down certain implementing measures for meat, live bivalve molluscs, fishery products, milk, eggs, frogs' legs and snails, and processed products thereof;

- Regulation 854/2004/EC lays down specific rules for the organisation of official controls on products of animal origin intended for human consumption. It is necessary to develop certain rules and further specify other requirements;

- Regulation 882/2004/EC establishes at Community level a harmonised framework of general rules for the organisation of official controls. It is necessary to develop certain rules and further specify other requirements.

The main elements of this Regulation are as follows :

- requirements concerning food chain information for the purpose of Regulations 853/2004/EC and 854/2004/EC;

- requirements concerning fishery products for the purpose of Regulations 853/2004/EC and 854/2004EC;

- recognised testing methods for marine biotoxins for the purpose of Regulations 853/2004/EC and 854/2004/EC;

- calcium content of mechanically separated meat for the purpose of Regulation 853/2004/EC;

- lists of establishments for the purpose of Regulation 882/2004/EC;

- model health certificates for frogs' legs, snails, gelatine and collagen for the purpose of Regulation 853/2004/EC;

- derogation from Regulation 852/2004/EC for foods with traditional characteristics.

ENTRY INTO FORCE : 11/01/2006. This Regulation shall apply from 01/01/2006 with the exception of Chapters II and III of Annex V (list of approved food establishments) which shall apply from 01/01/2007.

ACT : Commission Regulation 2075/2005/EC laying down specific rules on official controls for Trichinella in meat.

CONTENT : Regulations 853/2004/EC, 854/2004/EC and 882/2004/EC of the European Parliament and of the Council lay down the health rules and requirements regarding food of animal origin and the official controls required.

In addition to those rules, more specific requirements should be laid down for Trichinella. Meat of domestic swine, wild boar, horses and other animal species may be infested with nematodes of the genus Trichinella. Consumption of meat infested with Trichinella can cause serious disease in humans.

Consequently, this Regulation lays down measures to prevent human disease caused by the consumption of meat infested with Trichinella.

It defines:

- the obligations of competent authorities and of food business operators; sampling of carcases; derogations; trichinella examination and application of health mark; staff training; methods of detection; contingency plans; recognition of officially Trichinella-free holdings; obligations on food business operators to inform; monitoring programmes; withdrawal of official recognition of Trichinella-free holdings or regions with negligible risk;

- rules relating to import health requirements.

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

ACT : Commission Regulation 2076/2005/EC laying down transitional arrangements for the implementation of Regulations 853/2004/EC, 854/2004/EC and 882/2004/EC of the European Parliament and of the Council and amending Regulations 853/2004/EC and 854/2004/EC.

CONTENT : Regulations 853/2004/EC, 854/2004/EC and 882/2004/EC of the European Parliament and of the Council lay down the health rules and requirements regarding food of animal origin and the official controls required.

The entry into application on 1 January 2006 of these Regulations will entail considerable changes to the rules and procedures to be followed by food operators and the competent authorities of the Member States. The application of some of these measures with immediate effect from 1 January 2006 would present practical difficulties in some cases. A period should therefore be envisaged in order to permit a smooth transition to the full implementation of the new rules and procedures.

It is appropriate that the duration of the transitional period of 4 years, ending on 31 December 2009, be fixed taking into account a first review of the new regulatory framework on hygiene scheduled within the first four years. Provision should therefore be made for a transitional period during which certain requirements laid down in those Regulations can be progressively implemented. With a view to a harmonised approach, that transitional period should in principle last four years but could, where justified, be shorter. Provision should also be made for the possibility or reviewing any of those arrangements in the light of experience gained.

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

PURPOSE: to lay down rules on the microbiological sampling of eggs and of meat from bovine, porcine animals, poultry intended for Finland and Sweden.

LEGISLATIVE ACT: Commission Regulation

CONTENT: The microbiological sampling of eggs and meat from bovine and porcine animals, and poultry, intended for Finland and Sweden, shall be carried out in accordance with the provisions laid down in the Annex to this implementing Regulation.

Microbiological testing for salmonella of the samples taken in accordance with Articles 1 to 4 shall be carried out in accordance with the most recent edition of:

(a) standard EN/ISO 6579 (15) (EN/ISO 6579); or (b) method No 71 described by the Nordic Committee on Food Analysis (NMKL) (method No 71).

Where the results of the microbiological testing are contested between Member States, the most recent edition of EN/ISO 6579 shall be regarded as the reference method.

2. However, for samples of meat from bovine and porcine animals and of meat from poultry, the following analytical methods, which shall be validated by the use of meat samples in the validation studies, may be used for the microbiological testing for salmonella:

methods that have been validated against the most recent editions of EN/ISO 6579 or of method No 71 and if a proprietary method, certified by a third party in accordance with the protocol set out in standard EN/ISO 16140 (EN/ISO 16140) or other internationally accepted protocols.

ENTRY INTO FORCE: 04/11/2005.

DATE OF APPLICATION: 01/01/2006.

PURPOSE : to lay down specific rules on the hygiene of food of animal origin for food business operators.

LEGISLATIVE ACT : Regulation 853/2004/EC of the European Parliament and of the Council laying down specific hygiene rules for on the hygiene of foodstuffs. (Corrigendum to the Regulation published in OJ L 139 of 30 April 2004).

CONTENT : This Regulation results from a recast of Community legislation on food hygiene as contained in Council Directive 93/43/EEC and in a number of Council Directives on public health problems and governing the production and placing on the market of products of animal origin. The principal objectives of the recasting are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy. This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation 852/2004/EC. They apply to unprocessed and processed products of animal origin. The Regulation does not generally apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food must be obtained and handled in accordance with the requirements of this Regulation.

The rules do not apply either to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. Moreover, where small quantities of primary products or of certain types of meat are supplied directly by the food business operator producing them to the final consumer or to a local retail establishment, national law will operate because of the close relationship between the producer and the consumer. The requirements of Regulation 852/2004/EC are generally sufficient to ensure food safety in establishments carrying out retail activities involving the direct sale or supply of food of animal origin to the final consumer. This Regulation generally applies to wholesale activities (that is, when a retail establishment carries out operations with a view to supplying food of animal origin to another establishment). Nevertheless, with the exception of the specific temperature requirements laid down in this Regulation, the requirements of Regulation 852/2004/EC will suffice for wholesale activities consisting only of storage or transport.

The following points should be noted:

- Member States have some discretion to extend or to limit the application of the Regulation to retail under national law;

- in addition to complying with the general rules of Regulation 178/2002/EC, food business operators responsible for establishments that are subject to approval in accordance with this Regulation must ensure that all products of animal origin that they place on the market bear either a health mark or an identification mark;

- the structural and hygiene requirements laid down in this Regulation apply to all types of establishments, including small businesses and mobile slaughterhouses;

- to preserve certain hunting traditions without prejudicing food safety, the Regulation provides for training for hunters who place wild game on the market for human consumption. This enables hunters to undertake an initial examination of wild game on the spot. In these circumstances, they are not required to deliver all viscera to the game-handling establishment for post-mortem examination, if they carry out this initial examination and identify no anomalies or hazards. However, Member States are allowed to establish stricter rules within their territories to take account of specific risks; - the Regulation establishes criteria for raw milk pending the adoption of new requirements for its placing on the market. These criteria are trigger values, implying that, in the event of any overshooting, food business operators are to take corrective action and to notify the competent authority. The criteria do not involve maximum figures beyond which raw milk cannot be placed on the market; - the rules of this Regulation on eggs replace those of Council Decision 94/371/EC.

ENTRY INTO FORCE : 20/05/2004. The Regulation shall apply after 01/01/2006.