22.12.2005 EN Official Journal of the European Union L 338/1 COMMISSION REGULATION (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (1), and in particular Articles 4(4) and 12 thereof, Whereas: (1) A high level of protection of public health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (2). Microbiological hazards in foodstuffs form a major source of food-borne diseases in humans. (2) Foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. (3) Regulation (EC) No 178/2002 lays down general food safety requirements, according to which food must not be placed on the market if it is unsafe. Food business operators have an obligation to withdraw unsafe food from the market. 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. (4) 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. (5) The safety of foodstuffs is mainly ensured by a preventive approach, such as implementation of good hygiene practice and application of procedures based on hazard analysis and critical control point (HACCP) principles. Microbiological criteria can be used in validation and verification of HACCP procedures and other hygiene control measures. It is therefore appropriate to set microbiological criteria defining the acceptability of the processes, and also food safety microbiological criteria setting a limit above which a foodstuff should be considered unacceptably contaminated with the micro-organisms for which the criteria are set. (6) According to Article 4 of Regulation (EC) No 852/2004, food business operators are to comply with microbiological criteria. This should include testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective actions, in accordance with food law and the instructions given by the competent authority. It is therefore appropriate to lay down implementing measures concerning the analytical methods, including, where necessary, the measurement uncertainty, the sampling plan, the microbiological limits, the number of analytical units that should comply with these limits. Furthermore, it is appropriate to lay down implementing measures concerning the foodstuff to which the criterion applies, the points of the food chain where the criterion applies, as well as the actions to be taken when the criterion is not met. The measures to be taken by the food business operators in order to ensure compliance with criteria defining the acceptability of a process may include, among other things, controls of raw materials, hygiene, temperature and shelf-life of the product. (7) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (3) requires the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency. Those controls should take place at appropriate stages of the production, processing and distribution of food to ensure that the criteria laid down in this Regulation are complied with by food business operators. (8) The Communication from the Commission on the Community Strategy for setting microbiological criteria for foodstuffs (4) describes the strategy to lay down and revise the criteria in Community legislation, as well as the principles for the development and application of the criteria. This strategy should be applied when microbiological criteria are laid down. (9) The Scientific Committee on Veterinary Measures relating to Public Health (SCVPH) issued an opinion on 23 September 1999 on the evaluation of microbiological criteria for food products of animal origin for human consumption. It highlighted the relevance of basing microbiological criteria on formal risk assessment and internationally approved principles. The opinion recommends that microbiological criteria should be relevant and effective in relation to consumer health protection. The SCVPH proposed, while awaiting formal risk assessments, certain revised criteria as interim measures. (10) The SCVPH issued at the same time a separate opinion on Listeria monocytogenes. That opinion recommended that it be an objective to keep the concentration of Listeria monocytogenes in food below 100 cfu/g. The Scientific Committee on Food (SCF) agreed with these recommendations in its opinion of 22 June 2000. (11) The SCVPH adopted an opinion on Vibrio vulnificus and Vibrio parahaemolyticus on 19 and 20 September 2001. It concluded that currently available scientific data do not support setting specific criteria for pathogenic V. vulnificus and parahaemolyticus in seafood. However, it recommended that codes of practice should be established to ensure that good hygiene practice has been applied. (12) The SCVPH issued an opinion on Norwalk-like viruses (NLVs, noroviruses) on 30-31 January 2002. In that opinion it concluded that the conventional faecal indicators are unreliable for demonstrating the presence or absence of NLVs and that the reliance on faecal bacterial indicator removal for determining shellfish purification times is unsafe practice. It also recommended using E. coli rather than faecal coliforms to indicate faecal contamination in shellfish harvesting areas, when applying bacterial indicators. (13) On 27 February 2002 the SCF adopted an opinion on specifications for gelatine in terms of consumer health. It concluded that the microbiological criteria set in Chapter 4 of Annex II to Council Directive 92/118/EEC of 17 December 1992 laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC (5) in terms of consumer health were excessive, and considered it sufficient to apply a mandatory microbiological criterion for salmonella only. (14) The SCVPH issued an opinion on verotoxigenic E. coli (VTEC) in foodstuffs on 21 and 22 January 2003. In its opinion it concluded that applying an end-product microbiological standard for VTEC O157 is unlikely to deliver meaningful reductions in the associated risk for the consumers. However, microbiological guidelines aimed at reducing the faecal contamination along the food chain can contribute to a reduction in public health risks, including VTEC. The SCVPH identified the following food categories where VTEC represents a hazard to public health: raw or undercooked beef and possibly meat from other ruminants, minced meat and fermented beef and products thereof, raw milk and raw milk products, fresh produce, in particular sprouted seeds, and unpasteurised fruit and vegetable juices. (15) On 26 and 27 March 2003 the SCVPH adopted an opinion on staphylococcal enterotoxins in milk products, particularly in cheeses. It recommended revising the criteria for coagulase-positive staphylococci in cheeses, in raw milk intended for processing and in powdered milk. In addition, criteria for staphylococcal enterotoxins should be laid down for cheeses and powdered milk. (16) The SCVPH adopted an opinion on salmonellae in foodstuffs on 14 and 15 April 2003. According to the opinion, food categories possibly posing a high risk to public health include raw meat and some products intended to be eaten raw, raw and undercooked products of poultry meat, eggs and products containing raw eggs, unpasteurised milk and some products thereof. Sprouted seeds and unpasteurised fruit juices are also of concern. It recommended that the decision on the need for microbiological criteria should be taken on the basis of its ability to protect the consumers and its feasibility. (17) The Scientific Panel on Biological Hazards (BIOHAZ Panel) of the European Food Safety Authority (EFSA) issued an opinion on the microbiological risks in infant formulae and follow-on formulae on 9 September 2004. It concluded that Salmonella and Enterobacter sakazakii are the micro-organisms of greatest concern in infant formulae, formulae for special medical purposes and follow-on formulae. The presence of these pathogens constitutes a considerable risk if conditions after reconstitution permit multiplication. Enterobacteriaceae, which are more often present, could be used as an indicator for risk. Monitoring and testing of Enterobacteriaceae was recommended in both the manufacturing environment and the finished product by the EFSA. However, besides pathogenic species the family Enterobacteriaceae includes also environmental species, which often appear in the food manufacturing environment without posing any health hazard. Therefore, the family Enterobacteriaceae can be used for routine monitoring, and if they are present testing of specific pathogens can be started. (18) International guidelines for microbiological criteria in respect of many foodstuffs have not yet been established. However, the Commission has followed the Codex Alimentarius guideline ‘Principles for the establishment and application of microbiological criteria for foods CAC/GL 21 — 1997’ and in addition, the advice of the SCVPH and the SCF in laying down microbiological criteria. Existing Codex specifications in respect of dried milk products, foods for infants and children and the histamine criterion for certain fish and fishery products have been taken account. The adoption of Community criteria should benefit trade by providing harmonised microbiological requirements for foodstuffs and replacing national criteria. (19) The microbiological criteria set for certain categories of food of animal origin in Directives that were repealed by Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (6) should be revised and certain new criteria set in the light of the scientific advice. (20) The microbiological criteria laid down in Commission Decision 93/51 EEC of 15 December 1992 on the microbiological criteria applicable to the production of cooked crustaceans and molluscan shellfish (7) are incorporated in this Regulation. It is therefore appropriate to repeal that Decision. Since Commission Decision 2001/471/EC of 8 June 2001 laying down rules for the regular checks on the general hygiene carried out by the operators in establishments according to Directive 64/433/EEC on health conditions for the production and marketing of fresh meat and Directive 71/118/EEC on health problems affecting the production and placing on the market of fresh poultrymeat (8) is repealed with effect from the 1 January 2006, it is appropriate to incorporate microbiological criteria set for carcases in this Regulation. (21) The producer or manufacturer of a food product has to decide whether the product is ready to be consumed as such, without the need to cook or otherwise process it in order to ensure its safety and compliance with the microbiological criteria. According to Article 3 of Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (9), the instructions for use of a foodstuff are compulsory on the labelling when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions. Such instructions should be taken into account by food business operators when deciding appropriate sampling frequencies for the testing against microbiological criteria. (22) Sampling of the production and processing environment can be a useful tool to identify and prevent the presence of pathogenic micro-organisms in foodstuffs. (23) Food business operators should decide themselves the necessary sampling and testing frequencies as part of their procedures based on HACCP principles and other hygiene control procedures. However, it may be necessary in certain cases to set harmonised sampling frequencies at Community level, particularly in order to ensure the same level of controls to be performed throughout the Community. (24) Test results are dependent on the analytical method used, and therefore a given reference method should be associated with each microbiological criterion. However, food business operators should have the possibility to use analytical methods other than the reference methods, in particular more rapid methods, as long as the use of these alternative methods provides equivalent results. Moreover, a sampling plan needs to be defined for each criterion in order to ensure harmonised implementation. It is nevertheless necessary to allow the use of other sampling and testing schemes, including the use of alternative indicator organisms, on condition that these schemes provide equivalent guarantees of food safety. (25) Trends in test results should be analysed, as they are able to reveal unwanted developments in the manufacturing process enabling the food business operator to take corrective actions before the process is out of control. (26) The microbiological criteria set in this Regulation should be open to review and revised or supplemented, if appropriate, in order to take into account developments in the field of food safety and food microbiology. This includes progress in science, technology and methodology, changes in prevalence and contamination levels, changes in the population of vulnerable consumers, as well as the possible outputs from risk assessments. (27) In particular, criteria for pathogenic viruses in live bivalve molluscs should be established when the analytical methods are developed sufficiently. There is a need for development of reliable methods for other microbial hazards too, e.g. Vibrio parahaemolyticus. (28) It has been demonstrated that the implementation of control programmes can markedly contribute to a reduction of the prevalence of salmonella in production animals and products thereof. The purpose of Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (10) is to ensure that proper and effective measures are taken to control salmonella at relevant stages of the food chain. Criteria for meat and products thereof should take into account the expected improvement in the salmonella situation at the level of primary production. (29) For certain food safety criteria, it is appropriate to grant the Member States a transitional derogation, enabling them to comply with less stringent criteria but provided that the foodstuffs would only be marketed on the national market. The Member States should notify the Commission and other Member States where this transitional derogation is used. (30) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 Subject-matter and scope 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 (EC) No 852/2004. The competent authority shall verify compliance with the rules and criteria laid down in this Regulation in accordance with Regulation (EC) No 882/2004, 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 (EC) No 853/2004 of the European Parliament and of the Council (11), the rules on parasites laid down under Regulation (EC) No 854/2004 of the European Parliament and of the Council (12) and the microbiological criteria laid down under Council Directive 80/777/EEC (13). Article 2 Definitions The following definitions shall apply: (a) ‘micro-organisms’ means bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites; (b) ‘microbiological criterion’ means a criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch; (c) ‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market; (d) ‘process hygiene criterion’ a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law; (e) ‘batch’ means a group or set of identifiable products obtained from a given process under practically identical circumstances and produced in a given place within one defined production period; (f) ‘shelf-life’ means either the period corresponding to the period preceding the ‘use by’ or the minimum durability date, as defined respectively in Articles 9 and 10 of Directive 2000/13/EC; (g) ‘ready-to-eat food’ means food intended by the producer or the manufacturer for direct human consumption without the need for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms of concern; (h) ‘food intended for infants’ means food specifically intended for infants, as defined in Commission Directive 91/321/EEC (14); (i) ‘food intended for special medical purposes’ means dietary food for special medical purposes, as defined in Commission Directive 1999/21/EC (15); (j) ‘sample’ means a set composed of one or several units or a portion of matter selected by different means in a population or in an important quantity of matter, which is intended to provide information on a given characteristic of the studied population or matter and to provide a basis for a decision concerning the population or matter in question or concerning the process which has produced it; (k) ‘representative sample’ means a sample in which the characteristics of the batch from which it is drawn are maintained. This is in particular the case of a simple random sample where each of the items or increments of the batch has been given the same probability of entering the sample; (l) ‘compliance with microbiological criteria’ means obtaining satisfactory or acceptable results set in Annex I when testing against the values set for the criteria through the taking of samples, the conduct of analyses and the implementation of corrective action, in accordance with food law and the instructions given by the competent authority. Article 3 General requirements 1. Food business operators shall ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I. To this end the food business operators at each stage of food production, processing and distribution, including retail, shall take measures, as part of their procedures based on HACCP principles together with the implementation of good hygiene practice, to ensure the following: (a) that the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met, (b) that the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use. 2. As necessary, the food business operators responsible for the manufacture of the product shall conduct studies in accordance with Annex II in order to investigate compliance with the criteria throughout the shelf-life. In particular, this applies to ready-to-eat foods that are able to support the growth of Listeria monocytogenes and that may pose a Listeria monocytogenes risk for public health. Food businesses may collaborate in conducting those studies. Guidelines for conducting those studies may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004. Article 4 Testing against criteria 1. Food business operators shall perform testing as appropriate against the microbiological criteria set out in Annex I, when they are validating or verifying the correct functioning of their procedures based on HACCP principles and good hygiene practice. 2. Food business operators shall decide the appropriate sampling frequencies, except where Annex I provides for specific sampling frequencies, in which case the sampling frequency shall be at least that provided for in Annex I. Food business operators shall make this decision in the context of their procedures based on HACCP principles and good hygiene practice, taking into account the instructions for use of the foodstuff. The frequency of sampling may be adapted to the nature and size of the food businesses, provided that the safety of foodstuffs will not be endangered. Article 5 Specific rules for testing and sampling 1. The analytical methods and the sampling plans and methods in Annex I shall be applied as reference methods. 2. Samples shall be taken from processing areas and equipment used in food production, when such sampling is necessary for ensuring that the criteria are met. In that sampling the ISO standard 18593 shall be used as a reference method. Food business operators manufacturing ready-to-eat foods, which may pose a Listeria monocytogenes risk for public health, shall sample the processing areas and equipment for Listeria monocytogenes as part of their sampling scheme. Food business operators manufacturing dried infant formulae or dried foods for special medical purposes intended for infants below six months which pose an Enterobacter sakazakii risk shall monitor the processing areas and equipment for Enterobacteriaceae as part of their sampling scheme. 3. The number of sample units of the sampling plans set out in Annex I may be reduced if the food business operator can demonstrate by historical documentation that he has effective HACCP-based procedures. 4. If the aim of the testing is to specifically assess the acceptability of a certain batch of foodstuffs or a process, the sampling plans set out in Annex I shall be respected as a minimum. 5. Food business operators may use other sampling and testing procedures, if they can demonstrate to the satisfaction of the competent authority that these procedures provide at least equivalent guarantees. Those procedures may include use of alternative sampling sites and use of trend analyses. Testing against alternative micro-organisms and related microbiological limits as well as testing of analytes other than microbiological ones shall be allowed only for process hygiene criteria. The use of alternative analytical methods is acceptable when the methods are validated against the reference method in Annex I and if a proprietary method, certified by a third party in accordance with the protocol set out in EN/ISO standard 16140 or other internationally accepted similar protocols, is used. If the food business operator wishes to use analytical methods other than those validated and certified as described in paragraph 3 the methods shall be validated according to internationally accepted protocols and their use authorised by the competent authority. Article 6 Labelling requirements 1. When the requirements for Salmonella in minced meat, meat preparations and meat products intended to be eaten cooked of all species set down in Annex I are fulfilled, the batches of those products placed on the market must be clearly labelled by the manufacturer in order to inform the consumer of the need for thorough cooking prior to consumption. 2. As from 1 January 2010 labelling as referred to in paragraph 1 in respect of minced meat, meat preparations and meat products made from poultrymeat will no longer be required. Article 7 Unsatisfactory results 1. When the results of testing against the criteria set out in Annex I are unsatisfactory, the food business operators shall take the measures laid down in paragraphs 2 to 4 of this Article together with other corrective actions defined in their HACCP-based procedures and other actions necessary to protect the health of consumers. In addition, they shall take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene control measures in place. 2. When testing against food safety criteria set out in Chapter 1 of Annex I provides unsatisfactory results, the product or batch of foodstuffs shall be withdrawn or recalled in accordance with Article 19 of Regulation (EC) No 178/2002. However, products placed on the market, which are not yet at retail level and which do not fulfil the food safety criteria, may be submitted to further processing by a treatment eliminating the hazard in question. This treatment may only be carried out by food business operators other than those at retail level. The food business operator may use the batch for purposes other than those for which it was originally intended, provided that this use does not pose a risk for public or animal health and provided that this use has been decided within the procedures based on HACCP principles and good hygiene practice and authorised by the competent authority. 3. A batch of mechanically separated meat (MSM) produced with the techniques referred to in Chapter III, paragraph 3, in Section V of Annex III to Regulation (EC) No 853/2004, with unsatisfactory results in respect of the Salmonella criterion, may be used in the food chain only to manufacture heat-treated meat products in establishments approved in accordance with Regulation (EC) No 853/2004. 4. In the event of unsatisfactory results as regards process hygiene criteria the actions laid down in Annex I, Chapter 2 shall be taken. Article 8 Transitional derogation 1. A transitional derogation is granted until 31 December 2009 at the latest pursuant to Article 12 of Regulation (EC) No 852/2004 as regards compliance with the value set in Annex I to this Regulation for Salmonella in minced meat, meat preparations and meat products intended to be eaten cooked placed on the national market of a Member State. 2. The Member States using this possibility shall notify the Commission and other Member States thereof. The Member State shall: (a) guarantee that the appropriate means, including labelling and a special mark, which cannot be confused with the identification mark provided for in Annex II, Section I to Regulation (EC) No 853/2004, are in place to ensure that the derogation applies only to the products concerned when placed on the domestic market, and that products dispatched for intra-Community trade comply with the criteria laid down in Annex I; (b) provide that the products to which such transitional derogation applies shall be clearly labelled that they must be thoroughly cooked prior to consumption; (c) undertake that when testing against the Salmonella criterion pursuant to Article 4, and for the result to be acceptable as regards such transitional derogation, no more than one out of five sample units shall be found to be positive. Article 9 Analyses of trends Food business operators shall analyse trends in the test results. When they observe a trend towards unsatisfactory results, they shall take appropriate actions without undue delay to remedy the situation in order to prevent the occurrence of microbiological risks. Article 10 Review 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. Article 11 Repeal Decision 93/51/EEC is repealed. Article 12 This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union. It shall apply from 1 January 2006. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 15 November 2005. For the Commission Markos KYPRIANOU Member of the Commission (1) OJ L 139, 30.4.2004, p. 1, corrected by OJ L 226, 25.6.2004, p. 3. (2) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4). (3) OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1. (4) SANCO/1252/2001 Discussion paper on strategy for setting microbiological criteria for foodstuffs in Community legislation, p. 34. (5) OJ L 62, 15.3.1993, p. 49. Directive as last amended by Commission Regulation (EC) No 445/2004 (OJ L 72, 11.3.2004, p. 60). (6) OJ L 157, 30.4.2004, p. 33, corrected by OJ L 195, 2.6.2004, p. 12. (7) OJ L 13, 21.1.1993, p. 11. (8) OJ L 165, 21.6.2001, p. 48. Decision as amended by Decision 2004/379/EC (OJ L 144, 30.4.2004, p. 1). (9) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/89/EC (OJ L 308, 25.11.2003, p. 15). (10) OJ L 325, 12.12.2003, p. 1. (11) OJ L 139, 30.4.2004, p. 55, corrected by OJ L 226, 25.6.2004, p. 22. (12) OJ L 139, 30.4.2004, p. 206, corrected by OJ L 226, 25.6.2004, p. 83. (13) OJ L 229, 30.8.1980, p. 1. (14) OJ L 175, 4.7.1991, p. 35. (15) OJ L 91, 7.4.1999, p. 29. ANNEX I Microbiological criteria for foodstuffs Chapter 1. Food safety criteria Chapter 2. Process hygiene criteria 2.1. Meat and products thereof 2.2. Milk and dairy products 2.3. Egg products 2.4. Fishery products 2.5. Vegetables, fruits and products thereof Chapter 3. Rules for sampling and preparation of test samples 3.1. General rules for sampling and preparation of test samples 3.2. Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations Chapter 1. Food safety criteria Food category Micro-organisms/their toxins, metabolites Sampling-plan (1) Limits (2) Analytical reference method (3) Stage where the criterion applies n c m M 1.1. Ready-to-eat foods intended for infants and ready-to-eat foods for special medical purposes (4) Listeria monocytogenes 10 0 Absence in 25 g EN/ISO 11290-1 Products placed on the market during their shelf-life 1.2. Ready-to-eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes Listeria monocytogenes 5 0 100 cfu/g (5) EN/ISO 11290-2 (6) Products placed on the market during their shelf-life 5 0 Absence in 25 g (7) EN/ISO 11290-1 Before the food has left the immediate control of the food business operator, who has produced it 1.3. Ready-to-eat foods unable to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes (4) (8) Listeria monocytogenes 5 0 100 cfu/g EN/ISO 11290-2 (6) Products placed on the market during their shelf-life 1.4. Minced meat and meat preparations intended to be eaten raw Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.5. Minced meat and meat preparations made from poultry meat intended to be eaten cooked Salmonella 5 0 From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.6. Minced meat and meat preparations made from other species than poultry intended to be eaten cooked Salmonella 5 0 Absence in 10 g EN/ISO 6579 Products placed on the market during their shelf-life 1.7. Mechanically separated meat (MSM) (9) Salmonella 5 0 Absence in 10 g EN/ISO 6579 Products placed on the market during their shelf-life 1.8. Meat products intended to be eaten raw, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.9. Meat products made from poultry meat intended to be eaten cooked Salmonella 5 0 From 1.1.2006 Absence in 10 g From 1.1.2010 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.10. Gelatine and collagen Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.11. Cheeses, butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation (10) Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.12. Milk powder and whey powder (10) Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.13. Ice cream (11), excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.14. Egg products, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk Salmonella 5 0 Absence in 25g EN/ISO 6579 Products placed on the market during their shelf-life 1.15. Ready-to-eat foods containing raw egg, excluding products where the manufacturing process or the composition of the product will eliminate the salmonella risk Salmonella 5 0 Absence in 25 g or ml EN/ISO 6579 Products placed on the market during their shelf-life 1.16. Cooked crustaceans and molluscan shellfish Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.17. Live bivalve molluscs and live echinoderms, tunicates and gastropods Salmonella 5 0 Absence in 25g EN/ISO 6579 Products placed on the market during their shelf-life 1.18. Sprouted seeds (ready-to-eat) (12) Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.19. Pre-cut fruit and vegetables (ready-to-eat) Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.20. Unpasteurised fruit and vegetable juices (ready-to-eat) Salmonella 5 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.21. Cheeses, milk powder and whey powder, as referred to in the coagulase-positive staphylococci criteria in Chapter 2.2 of this Annex Staphylococcal enterotoxins 5 0 Not detected in 25g European screening method of the CRL for Milk (13) Products placed on the market during their shelf-life 1.22. Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age, as referred to in the Enterobacteriaceae criterion in Chapter 2.2 of this Annex Salmonella 30 0 Absence in 25 g EN/ISO 6579 Products placed on the market during their shelf-life 1.23. Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age, as referred to in the Enterobacteriaceae criterion in Chapter 2.2 of this Annex Enterobacter sakazakii 30 0 Absence in 10 g ISO/DTS 22964 Products placed on the market during their shelf-life 1.24. Live bivalve molluscs and live echinoderms, tunicates and gastropods E.coli (14) 1 (15) 0 230 MPN/100g of flesh and intra-valvular liquid ISO TS 16649-3 Products placed on the market during their shelf-life 1.25. Fishery products from fish species associated with a high amount of histidine (16) Histamine 9 (17) 2 100 mg/kg 200 mg/kg HPLC (18) Products placed on the market during their shelf-life 1.26. Fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histidine (16) Histamine 9 2 200 mg/kg 400 mg/kg HPLC (18) Products placed on the market during their shelf-life Interpretation of the test results The limits given refer to each sample unit tested, excluding live bivalve molluscs and live echinoderms, tunicates and gastropods in relation to testing E. coli, where the limit refers to a pooled sample. The test results demonstrate the microbiological quality of the batch tested (19). L. monocytogenes in ready-to-eat foods intended for infants and for special medical purposes: — satisfactory, if all the values observed indicate the absence of the bacterium, — unsatisfactory, if the presence of the bacterium is detected in any of the sample units. L. monocytogenes in ready-to-eat foods able to support the growth of L. monocytogenes before the food has left the immediate control of the producing food business operator when he is not able to demonstrate that the product will not exceed the limit of 100 cfu/g throughout the shelf-life: — satisfactory, if all the values observed indicate the absence of the bacterium, — unsatisfactory, if the presence of the bacterium is detected in any of the sample units. L. monocytogenes in other ready-to-eat foods and E. coli in live bivalve molluscs: — satisfactory, if all the values observed are ≤ the limit, — unsatisfactory, if any of the values are > the limit. Salmonella in different food categories: — satisfactory, if all the values observed indicate the absence of the bacterium, — unsatisfactory, if the presence of the bacterium is detected in any of the sample units. Staphylococcal enterotoxins in dairy products: — satisfactory, if in all the sample units the enterotoxins are not detected, — unsatisfactory, if the enterotoxins are detected in any of the sample units. Enterobacter sakazakii in dried infant formulae and dried dietary foods for special medical purposes intended for infants below 6 months of age: — satisfactory, if all the values observed indicate the absence of the bacterium, — unsatisfactory, if the presence of the bacterium is detected in any of the sample units. Histamine in fishery products from fish species associated with a high amount of histidine: — satisfactory, if the following requirements are fulfilled: 1. the mean value observed is ≤ m 2. a maximum of c/n values observed are between m and M 3. no values observed exceed the limit of M, — unsatisfactory, if the mean value observed exceeds m or more than c/n values are between m and M or one or more of the values observed are >M. Chapter 2. Process hygiene criteria 2.1. Meat and products thereof Food category Micro-organisms Sampling plan (20) Limits (21) Analytical reference method (22) Stage where the criterion applies Action in case of unsatisfactory results n c m M 2.1.1. Carcases of cattle, sheep, goats and horses (23) Aerobic colony count 3,5 log cfu/cm2 daily mean log 5,0 log cfu/cm2 daily mean log ISO 4833 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls Enterobacteriaceae 1,5 log cfu/cm2 daily mean log 2,5 log cfu/cm2 daily mean log ISO 21528-2 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls 2.1.2. Carcases of pigs (23) Aerobic colony count 4,0 log cfu/cm2 daily mean log 5,0 log cfu/cm2 daily mean log ISO 4833 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls Enterobacteriaceae 2,0 log cfu/cm2 daily mean log 3,0 log cfu/cm2 daily mean log ISO 21528-2 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls 2.1.3. Carcases of cattle, sheep, goats and horses Salmonella 50 (24) 2 (25) Absence in the area tested per carcase EN/ISO 6579 Carcases after dressing but before chilling Improvements in slaughter hygiene, review of process controls and of origin of animals 2.1.4. Carcases of pig Salmonella 50 (24) 5 (25) Absence in the area tested per carcase EN/ISO 6579 Carcases after dressing but before chilling Improvements in slaughter hygiene and review of process controls, origin of animals and of the biosecurity measures in the farms of origin 2.1.5. Poultry carcases of broilers and turkeys Salmonella 50 (24) 7 (25) Absence in 25 g of a pooled sample of neck skin EN/ISO 6579 Carcases after chilling Improvements in slaughter hygiene and review of process controls, origin of animals and biosecurity measures in the farms of origin 2.1.6. Minced meat Aerobic colony count (26) 5 2 5x105 cfu/g 5x106 cfu/g ISO 4833 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials E.coli (27) 5 2 50 cfu/g 500 cfu/g ISO 16649-1 or 2 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials 2.1.7. Mechanically separated meat (MSM) (28) Aerobic colony count 5 2 5x105 cfu/g 5x106 cfu/g ISO 4833 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials E.coli (27) 5 2 50 cfu/g 500 cfu/g ISO 16649-1 or 2 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials 2.1.8. Meat preparations E.coli (27) 5 2 500 cfu/g or cm2 5 000 cfu/g or cm2 ISO 16649-1 or 2 End of the manufacturing process Improvements in production hygiene and improvements in selection and/or origin of raw materials Interpretation of the test results The limits given refer to each sample unit tested, excluding testing of carcases where the limits refer to pooled samples. The test results demonstrate the microbiological quality of the process tested. Enterobacteriaceae and aerobic colony count in carcases of cattle, sheep, goats, horses and pigs: — satisfactory, if the daily mean log is < m, — acceptable, if the daily mean log is between m and M, — unsatisfactory, if the daily mean log is >M. Salmonella in carcases: — satisfactory, if the presence of Salmonella is detected in a maximum of c/n samples, — unsatisfactory, if the presence of Salmonella is detected in more than c/n samples. After each sampling session, the results of the last ten sampling sessions are assessed in order to obtain the n number of samples. E. coli and aerobic colony count in minced meat, meat preparations and mechanically separated meat (MSM): — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are < m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. 2.2. Milk and dairy products Food category Micro-organisms Sampling plan (29) Limits (30) Analytical reference method (31) Stage where the criterion applies Action in case of unsatisfactory results n c m M 2.2.1. Pasteurised milk and other pasteurised liquid dairy products (32) Enterobacteriaceae 5 2 <1 cfu/ml 5 cfu/ml ISO 21528-1 End of the manufacturing process Check on the efficiency of heat- treatment and prevention of recontamination as well as the quality of raw materials 2.2.2. Cheeses made from milk or whey that has undergone heat treatment E.coli (33) 5 2 100 cfu/g 1 000 cfu/g ISO 16649- 1 or 2 At the time during the manufacturing process when the E. coli count is expected to be highest (34) Improvements in production hygiene and selection of raw materials 2.2.3. Cheeses made from raw milk Coagulase-positive staphylococci 5 2 104 cfu/g 105 cfu/g EN/ISO 6888-2 At the time during the manufacturing process when the number of staphylococci is expected to be highest Improvements in production hygiene and selection of raw materials. If values >105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins. 2.2.4. Cheeses made from milk that has undergone a lower heat treatment than pasteurisation (35) and ripened cheeses made from milk or whey that has undergone pasteurisation or a stronger heat treatment (35) Coagulase-positive staphylococci 5 2 100 cfu/g 1 000 cfu/g EN/ISO 6888-1 or 2 2.2.5. Unripened soft cheeses (fresh cheeses) made from milk or whey that has undergone pasteurisation or a stronger heat treatment (35) Coagulase-positive staphylococci 5 2 10 cfu/g 100 cfu/g EN/ISO 6888-1 or 2 End of the manufacturing process Improvements in production hygiene. If values > 105 cfu/g are detected, the cheese batch has to be tested for staphylococcal enterotoxins. 2.2.6. Butter and cream made from raw milk or milk that has undergone a lower heat treatment than pasteurisation E.coli (33) 5 2 10 cfu/g 100 cfu/g ISO 16649- 1 or 2 End of the manufacturing process Improvements in production hygiene and selection of raw materials 2.2.7. Milk powder and whey powder (32) Enterobacteriaceae 5 0 10 cfu/g ISO 21528- 1 End of the manufacturing process Check on the efficiency of heat treatment and prevention of recontamination Coagulase-positive staphylococci 5 2 10 cfu/g 100 cfu/g EN/ISO 6888-1 or 2 End of the manufacturing process Improvements in production hygiene. If values > 105 cfu/g are detected, the batch has to be tested for staphylococcal enterotoxins. 2.2.8. Ice cream (36) and frozen dairy desserts Enterobacteriaceae 5 2 10 cfu/g 100 cfu/g ISO 21528- 2 End of the manufacturing process Improvements in production hygiene 2.2.9. Dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age Enterobacteriaceae 10 0 Absence in 10 g ISO 21528- 1 End of the manufacturing process Improvements in production hygiene to minimise contamination. If Enterobacteriaceae are detected in any of the sample units, the batch has to be tested for E. sakazakii and Salmonella Interpretation of the test results The limits given refer to each sample unit tested. The test results demonstrate the microbiological quality of the process tested. Enterobacteriaceae in dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age: — satisfactory, if all the values observed indicate the absence of the bacterium, — unsatisfactory, if the presence of the bacterium is detected in any of the sample units E. coli, enterobacteriaceae (other food categories) and coagulase-positive staphylococci: — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are < m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. 2.3. Egg products Food category Micro-organisms Sampling plan (37) Limits Analytical reference method (38) Stage where the criterion applies Action in case of unsatisfactory results n c m M 2.3.1. Egg products Enterobacteriaceae 5 2 10 cfu/g or ml 100 cfu/g or ml ISO 21528-2 End of the manufacturing process Checks on the efficiency of the heat treatment and prevention of recontamination Interpretation of the test results The limits given refer to each sample unit tested. The test results demonstrate the microbiological quality of the process tested. Enterobacteriaceae in egg products: — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are < m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. 2.4. Fishery products Food category Micro-organisms Sampling plan (39) Limits Analytical reference method (40) Stage where the criterion applies Action in case of unsatisfactory results n c m M 2.4.1. Shelled and shucked products of cooked crustaceans and molluscan shellfish E.coli 5 2 1 cfu/g 10 cfu/g ISO TS 16649-3 End of the manufacturing process Improvements in production hygiene Coagulase-positive staphylococci 5 2 100 cfu/g 1 000 cfu/g EN/ISO 6888-1 or 2 End of the manufacturing process Improvements in production hygiene Interpretation of the test results The limits given refer to each sample unit tested. The test results demonstrate the microbiological quality of the process tested. E. coli in shelled and shucked products of cooked crustaceans and molluscan shellfish: — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. Coagulase-positive staphylococci in shelled and cooked crustaceans and molluscan shellfish: — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are < m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. 2.5. Vegetables, fruits and products thereof Food category Micro-organisms Sampling plan (41) Limits Analytical reference method (42) Stage where the criterion applies Action in case of unsatisfactory results n c m M 2.5.1. Pre-cut fruit and vegetables (ready-to-eat) E.coli 5 2 100 cfu/g 1 000 cfu/g ISO 16649- 1 or 2 Manufacturing process Improvements in production hygiene, selection of raw materials 2.5.2. Unpasteurised fruit and vegetable juices (ready-to-eat) E.coli 5 2 100 cfu/g 1 000 cfu/g ISO 16649- 1 or 2 Manufacturing process Improvements in production hygiene, selection of raw materials Interpretation of the test results The limits given refer to each sample unit tested. The test results demonstrate the microbiological quality of the process tested. E. coli in pre-cut fruit and vegetables (ready-to-eat) and in unpasteurised fruit and vegetable juices (ready-to-eat): — satisfactory, if all the values observed are < m, — acceptable, if a maximum of c/n values are between m and M, and the rest of the values observed are ≤ m, — unsatisfactory, if one or more of the values observed are >M or more than c/n values are between m and M. Chapter 3. Rules for sampling and preparation of test samples 3.1. General rules for sampling and preparation of test samples In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO (International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used as reference methods. 3.2. Bacteriological sampling in slaughterhouses and at premises producing minced meat and meat preparations Sampling rules for carcases of cattle, pigs, sheep, goats and horses The destructive and non-destructive sampling methods, the selection of the sampling sites and the rules for storage and transport of samples are described in standard ISO 17604. Five carcases shall be sampled at random during each sampling session. Sample sites should be selected taking into account the slaughter technology used in each plant. When sampling for analyses of enterobacteriaceae and aerobic colony counts, four sites of each carcase shall be sampled. Four tissue samples representing a total of 20 cm2 shall be obtained by the destructive method. When using the non-destructive method for this purpose, the sampling area shall cover a minimum of 100 cm2 (50 cm2 for small ruminant carcases) per sampling site. When sampling for Salmonella analyses, an abrasive sponge sampling method shall be used. The sampling area shall cover a minimum of 100 cm2 per site selected. When samples are taken from the different sampling sites on the carcase, they shall be pooled before examination. Sampling rules for poultry carcases For the Salmonella analyses, a minimum of 15 carcases shall be sampled at random during each sampling session and after chilling. A piece of approximately 10 g from neck skin shall be obtained from each carcase. On each occasion the neck skin samples from three carcases shall be pooled before examination in order to form 5 x 25 g final samples. Guidelines for sampling More detailed guidelines on the sampling of carcases, in particular concerning the sampling sites, may be included in the guides to good practice referred to in Article 7 of Regulation (EC) No 852/2004. Sampling frequencies for carcases, minced meat, meat preparations and mechanically separated meat However, when justified on the basis of a risk analysis and consequently authorised by the competent authority, small slaughterhouses and establishments producing minced meat and meat preparations in small quantities may be exempted from these sampling frequencies. In the case of sampling for Salmonella analyses of minced meat, meat preparations and carcases, the frequency can be reduced to fortnightly if satisfactory results have been obtained for 30 consecutive weeks. The salmonella sampling frequency may also be reduced if there is a national or regional salmonella control programme in place and if this programme includes testing that replaces the described sampling. The sampling frequency may be further reduced if the national or regional salmonella control programme demonstrates that the salmonella prevalence is low in animals purchased by the slaughterhouse. As regards the sampling of minced meat and meat preparations for E. coli and aerobic colony count analyses and the sampling of carcases for enterobacteriaceae and aerobic colony count analyses, the frequency may be reduced to fortnightly testing if satisfactory results are obtained for six consecutive weeks. The food business operators of slaughterhouses or establishments producing minced meat, meat preparations or mechanically separated meat shall take samples for microbiological analysis at least once a week. The day of sampling shall be changed each week to ensure that each day of the week is covered. (1) n = number of units comprising the sample; c = number of sample units giving values over m or between m and M. (2) For points 1.1-1.24 m=M. (3) The most recent edition of the standard shall be used. (4) Regular testing against the criterion is not useful in normal circumstances for the following ready-to-eat foods: — those which have received heat treatment or other processing effective to eliminate L. monocytogenes, when recontamination is not possible after this treatment (e.g. products heat treated in their final package), — fresh, uncut and unprocessed vegetables and fruits, excluding sprouted seeds, — bread, biscuits and similar products, — bottled or packed waters, soft drinks, beer, cider, wine, spirits and similar products, — sugar, honey and confectionery, including cocoa and chocolate products, — live bivalve molluscs. (5) This criterion applies if the manufacturer is able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit 100 cfu/g throughout the shelf-life. The operator may fix intermediate limits during the process that should be low enough to guarantee that the limit of 100 cfu/g is not exceeded at the end of the shelf-life. (6) 1 ml of inoculum is plated on a Petri dish of 140 mm diameter or on three Petri dishes of 90 mm diameter. (7) This criterion applies to products before they have left the immediate control of the producing food business operator, when he is not able to demonstrate, to the satisfaction of the competent authority, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life. (8) Products with pH ≤ 4,4 or aw ≤ 0,92, products with pH ≤ 5,0 and aw ≤ 0,94, products with a shelf-life of less than five days are automatically considered to belong to this category. Other categories of products can also belong to this category, subject to scientific justification. (9) This criterion applies to mechanically separated meat (MSM) produced with the techniques referred to in Chapter III, paragraph 3, in section V of Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. (10) Excluding products when the manufacturer can demonstrate to the satisfaction of the competent authorities that, due to the ripening time and aw of the product where appropriate, there is no salmonella risk. (11) Only ice creams containing milk ingredients. (12) Preliminary testing of the batch of seeds before starting the sprouting process or the sampling to be carried out at the stage where the highest probability of finding Salmonella is expected. (13) Reference: Hennekinne et al., J. AOAC Internat. Vol. 86, No 2, 2003. (14) E. coli is used here as an indicator of faecal contamination. (15) A pooled sample comprising a minimum of 10 individual animals. (16) Particularly fish species of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Pomatomidae, Scombresosidae. (17) Single samples may be taken at retail level. In such a case the presumption laid down in Article 14(6) of Regulation (EC) No 178/2002, according to which the whole batch should be deemed unsafe, shall not apply. (18) References: 1. Malle P., Valle M., Bouquelet S. Assay of biogenic amines involved in fish decomposition. J. AOAC Internat. 1996, 79, 43-49. 2. Duflos G., Dervin C., Malle P., Bouquelet S. Relevance of matrix effect in determination of biogenic amines in plaice (Pleuronectes platessa) and whiting (Merlangus merlangus). J. AOAC Internat. 1999, 82, 1097-1101. (19) The test results can be used also for demonstrating the effectiveness of the HACCP or good hygiene procedure of the process. (20) n = number of units comprising the sample; c = number of sample units giving values between m and M. (21) For points 2.1.3 — 2.1.5 m=M. (22) The most recent edition of the standard shall be used. (23) The limits (m and M) apply only to samples taken by the destructive method. The daily mean log is calculated by first taking a log value of each individual test result and then calculating the mean of these log values. (24) The 50 samples are derived from 10 consecutive sampling sessions in accordance with the sampling rules and frequencies laid down in this Regulation. (25) The number of samples where the presence of salmonella is detected. The c value is subject to review in order to take into account the progress made in reducing the salmonella prevalence. Member States or regions having low salmonella prevalence may use lower c values even before the review. (26) This criterion does not apply to minced meat produced at retail level when the shelf-life of the product is less then 24 hours. (27) E. coli is used here as an indicator of faecal contamination. (28) These criteria apply to mechanically separated meat (MSM) produced with the techniques referred to in Chapter III, paragraph 3, in section V of Annex III of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin. (29) n = number of units comprising the sample; c = number of sample units giving values between m and M. (30) For point 2.2.7 m=M. (31) The most recent edition of the standard shall be used. (32) The criterion does not apply to products intended for further processing in the food industry. (33) E. coli is used here as an indicator for the level of hygiene. (34) For cheeses which are not able to support the growth of E. coli, the E. coli count is usually the highest at the beginning of the ripening period, and for cheeses which are able to support the growth of E. coli, it is normally at the end of the ripening period. (35) Excluding cheeses where the manufacturer can demonstrate, to the satisfaction of the competent authorities, that the product does not pose a risk of staphylococcal enterotoxins. (36) Only ice creams containing milk ingredients. (37) n = number of units comprising the sample; c = number of sample units giving values between m and M. (38) The most recent edition of the standard shall be used. (39) n = number of units comprising the sample; c = number of sample units giving values between m and M. (40) The most recent edition of the standard shall be used. (41) n = number of units comprising the sample; c = number of sample units giving values between m and M. (42) The most recent edition of the standard shall be used. ANNEX II The studies referred to in Article 3(2) shall include: — specifications for physico-chemical characteristics of the product, such as pH, aw, salt content, concentration of preservatives and the type of packaging system, taking into account the storage and processing conditions, the possibilities for contamination and the foreseen shelf-life, and — consultation of available scientific literature and research data regarding the growth and survival characteristics of the micro-organisms of concern. When necessary on the basis of the abovementioned studies, the food business operator shall conduct additional studies, which may include: — predictive mathematical modelling established for the food in question, using critical growth or survival factors for the micro-organisms of concern in the product, — tests to investigate the ability of the appropriately inoculated micro-organism of concern to grow or survive in the product under different reasonably foreseeable storage conditions, — studies to evaluate the growth or survival of the micro-organisms of concern that may be present in the product during the shelf-life under reasonably foreseeable conditions of distribution, storage and use. The above mentioned studies shall take into account the inherent variability linked to the product, the micro-organisms in question and the processing and storage conditions.

Summary: Foods — microbiological criteria Foods — microbiological criteria SUMMARY OF: Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs WHAT IS THE AIM OF THE REGULATION? In the interests of food safety and public health, it lays down the microbiological criteria* for certain micro-organisms* and the rules which food businesses must follow with respect to the general and specific hygiene requirements laid down in Regulation (EC) No 852/2004 on the hygiene of foodstuffs. The purpose is to provide objectives and reference points to assist food businesses and EU countries’ competent authorities to manage and monitor the safety of food. The regulation requires food businesses to ensure that the food they handle, supply or process complies with these criteria. KEY POINTS Microbiological criteria The regulation sets out 2 types of microbiological criteria with which food businesses must comply, listed in its Annex I: food safety criteria; process hygiene criteria. Food businesses at each stage of food production, processing and distribution, including retail, must, as part of their procedures based on HACCP principles* and using good hygiene practice, ensure that: the supply, handling and processing of raw materials and foodstuffs under their control are carried out in such a way that the process hygiene criteria are met; the food safety criteria applicable throughout the shelf-life of the products can be met under reasonably foreseeable conditions of distribution, storage and use. For each food category, the regulation and its annex specify: the micro-organisms for which it must be tested; the sampling plan (the number of units to be tested, frequency, etc.); the limits for each sample unit tested; the analytical reference method to be used; the stage at which the criterion applies (e.g. end of the manufacturing process, at the time in the manufacturing process when the count of a given micro-organism is expected to be highest); the action in case of unsatisfactory results. Testing and its scope Food businesses must ensure foods comply with the relevant criteria, and perform appropriate testing for the criteria set out in Annex I. The criteria relate to the following products: ready-to-eat foods; fresh poultry meat; minced meat and meat preparations; meat products; mechanically-separated meat; gelatine and collagen; dairy products; egg products; live bivalve molluscs; fishery products; cooked crustaceans and molluscan shellfish; pre-cut, ready-to eat fruit and vegetables; sprouts and sprouted seeds; unpasteurised, ready-to-eat fruit and vegetable juices; and carcases. The rules for sampling and for the preparation of test samples are laid down in Annex I. Results If test results for either type of criteria are unsatisfactory, food businesses must take the action set out in the regulation. When they observe a trend towards unsatisfactory results, they must take appropriate actions without undue delay to prevent the occurrence of microbiological risks. FROM WHEN DOES THE REGULATION APPLY? It has applied since 1 January 2006. BACKGROUND For more information, see: Microbiological criteria (European Commission) European Food Safety Authority (European Food Safety Authority). KEY TERMS Microbiological criteria: because foods derived from animals and plants may present a microbiological risk, these criteria give guidance on the acceptability of foodstuffs and their manufacturing processes. The criteria define the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch. Micro-organism: includes bacteria, viruses, yeasts, moulds, algae, parasitic protozoa, microscopic parasitic helminths, and their toxins and metabolites. Common examples include salmonella, listeria and E. coli. HACCP (Hazard Analysis Critical Control Point) principles: based on 7 internationally agreed principles which identify, evaluate and control hazards relevant to food safety. It focuses on preventing contamination and places a responsibility on food producers to ensure that their product is safe. MAIN DOCUMENT Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, pp. 1-26) Successive amendments to Regulation (EC) No 2073/2005 have been incorporated into the original document. This consolidated version is of documentary value only. RELATED DOCUMENTS Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1-142) See consolidated version. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, pp. 1-54). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 3-21) See consolidated version. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 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 (OJ L 31, 1.2.2002, pp. 1-24) See consolidated version. last update 17.05.2019


EUR-Lex - 31960R0011 - EN Avis juridique important | 31960R0011 EEC Council: Regulation No 11 concerning the abolition of discrimination in transport rates and conditions, in implementation of Article 79 (3) of the Treaty establishing the European Economic Community Official Journal 052 , 16/08/1960 P. 1121 - 1126 Finnish special edition: Chapter 7 Volume 1 P. 0023 Swedish special edition: Chapter 7 Volume 1 P. 0023 Danish special edition: Series I Chapter 1959-1962 P. 0056 English special edition: Series I Chapter 1959-1962 P. 0060 Greek special edition: Chapter 07 Volume 1 P. 0020 Spanish special edition: Chapter 07 Volume 1 P. 0032 Portuguese special edition Chapter 07 Volume 1 P. 0032 REGULATION No 11 concerning the abolition of discrimination in transport rates and conditions, in implementation of Article 79 (3) of the Treaty establishing the European Economic Community THE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, Having regard to the Treaty establishing the European Economic Community, and in particular Article 79 thereof; Having regard to the proposal from the Commission; Having regard to the Opinion of the Economic and Social Committee; Whereas Article 79 (3) requires the Council to lay down rules for the abolition, as regards transport within the Community, of the forms of discrimination referred to in Article 79 (1); Whereas such abolition requires the prohibition of the above-mentioned forms of discrimination, including the fixing by tariff or otherwise, of transport rates and conditions which, when applied, would constitute discrimination; Whereas it will only be possible to check what transport rates and conditions are being applied and to detect any discrimination if carriers and agents concerned with the carriage of goods are required to supply the necessary information, to make out a transport document enabling such information to be checked and to submit themselves to inspection; Whereas, for the purpose of ensuring compliance wich these provisions, there should be instituted a system of penalties, such penalties to be subject to review by the Court of Justice exercising unlimited jurisdiction, as provided for in Article 172 of the Treaty; HAS ADOPTED THIS REGULATION: Article 1 The provisions of this Regulation shall apply to the carriage of all goods by rail, road or inland waterway within the Community, with the exception of goods listed in Annexes I and III to the Treaty establishing the European Coal and Steel Community. Article 2 1. The provisions of this Regulation shall apply to all carriage of goods consigned from or to a point within the territory of a Member State, including the carriage thereof between Member States and third or associated countries. 2. This Regulation shall apply only to those parts of a journey which take place within the Community. 3. This Regulation shall apply also to those parts of a journey effected by rail, road or inland waterway where the goods are carried by other modes of transport over other parts of the journey. Article 3 Where a carriage regulated by the terms of a single contract is performed by successive carriers, each such carrier shall be subject to the provisions of this Regulation in respect of that part of the carriage which he performs. Article 4 1. In the case of transport within the Community, all discrimination by carriers which takes the form of charging different rates and imposing different conditions for carrying the same goods over the same transport links on grounds of the country of origin or of destination of the goods in question shall be prohibited. This prohibition shall not affect the validity of private law contracts. 2. The fixing, by tariff or otherwise, of transport rates and conditions which, when applied, would constitute discrimination within the meaning of paragraph 1 shall also be prohibited. 3. The prohibitions laid down in this Article shall take effect from 1 July 1961. Article 5 1. Before 1 July 1961 Governments shall notify the Commission of any tariff, or formal or other agreement on transport rates and conditions operating in their respective countries, whereby the rates and conditions for carrying the same goods over the same transport links vary according to the country of origin or of destination of the goods in question. Any measure of this kind subsequently introduced shall also be immediately notified to the Commission. 2. Before 1 July 1961 transport undertakings shall supply their respective Governments with all relevant information concerning the tariffs, and formal or other agreements on transport rates and conditions referred to in the preceding paragraph and shall notify them forthwith of any measure of this kind subsequently introduced. 3. The provisions of this Article shall apply to the carriage of goods consigned from or to a point within the territory of a Member State. Article 6 1. A transport document giving the following details shall be required for each consignment of goods within the Community: - name and address of the consignor; - nature and weight of the goods; - place and date of acceptance of the goods for transport; - place at which the goods are to be delivered; - route to be taken, or distance to be travelled, if these factors justify a rate different from that normally applicable; - frontier crossing points, where appropriate. 2. Transport documents shall be made out in duplicate and shall be numbered. One copy shall accompany the goods; the other copy shall be retained by the carrier for two years, reckoned from the date of carriage, and shall be filed in numerical order. The latter copy shall show the full and final transport charges, whatever the form in which they may be made, any other charges and any rebates or other factors affecting the transport rates and conditions. 3. Where existing documents give all the details specified in paragraph 1 and, in conjunction with carriers' recording and accounting systems, enable a full check to be made of transport rates and conditions, so that the forms of discrimination referred to in Article 79 (1) of the Treaty may be thereby abolished or avoided, carriers shall not be required to introduce new documents. 4. The carrier shall be responsible for the proper preparation of transport documents. Article 7 1. The provisions of Article 6 shall enter into force on 1 July 1961. 2. The Commission may, however, before that date and by a Regulation issued after consulting the Council, postpone for certain classes of transport to be determined later such entry into force until 1 January 1964 at the latest. Article 8 The provisions of Article 6 shall not apply: (a) to the carriage of goods not exceeding five metric tons in total weight consigned by a single consignor to a single consignee; (b) to the carriage of goods within a Member State over a distance which in total does not exceed one hundred kilometres; (c) to the carriage of goods between Member States for a distance which in total does not exceed 30 kilometres. Article 9 The provisions of Article 6 shall not apply to the carriage of goods by an undertaking for its own requirements, subject to the following conditions: - the goods must be carried by vehicles owned or obtained on deferred terms by the undertaking and driven by its own employee or employees; - transport must be only ancillary to the overall activities of the undertaking; - the goods carried must be the property of the undertaking or must have been sold, bought, loaned, borrowed, let out on hire or hired, produced, processed or repaired by the undertaking; - the purpose of the journey must be to carry the goods to or from the undertaking or to move them, either inside the undertaking, or outside for its own requirements. Article 10 If, by 1 July 1963, no rules have been made under Article 74 and in implementation of Article 75 of the Treaty as regards the publication of transport rates and conditions, decisions concerning the nature, form and extent of such publication shall be taken, together with any other appropriate measures, within the limits of, and as provided in Article 79 (1) and (3) of the Treaty, account being taken of the fact that such decisions and measures must in all cases be consistent with the common transport policy. Article 11 1. Without prejudice to Article 5 of this Regulation, Governments and undertakings shall, at the request of the Commission, supply any additional information which may be needed concerning any tariff, or formal or other agreement on transport rates and conditions. 2. The Commission may set a time limit of not less than one month for the forwarding of such information. 3. If the Commission requests an undertaking to supply it with information the Commission shall immediately notify the Government of the Member State in which the undertaking has its seat by forwarding a copy of the request for information to that Government. 4. Information may be refused if it involves the disclosure of any facts which a Member State considers would be contrary to the essential interests of its security. Article 12 1. Any carrier who charges different rates and imposes different conditions for the carriage of the same goods over the same transport links according to the country of origin or of destination of the goods in question shall, if so required by the Commission, show that such action is not in breach of the provisions of this Regulation. 2. The charging of different rates and the imposing of different conditions shall not constitute a breach of this Regulation if it results solely from competition between carriers or is due to operating conditions, whether technical or economic, peculiar to carriage over the transport link in question. Article 13 1. Forwarding and other agents concerned with the carriage of goods shall, if so required by their Government or by the Commission, supply all information relevant to the services provided and to the rates and conditions applied. 2. This requirement shall also apply to direct providers of services ancillary to carriage in any case where the remuneration payable to them and that payable to the carriers are comprised in a single overall charge. 3. The provisions of Article 11 (2), (3) and (4) shall also apply to requests for information made in pursuance of this Article. Article 14 1. Member States shall be responsible for checking compliance with the obligations imposed on carriers by Articles 5 (2), 6 and 11 of this Regulation and with the obligation to supply information as laid down in Article 13. They shall introduce the necessary measures for this purpose before 1 July 1961, after consulting the Commission. 2. In so far as may be necessary in order to implement this Regulation, the Commission may send its officials or any experts on visits of inspection to check and supervise compliance with the obligations imposed on undertakings by Articles 5, 6, 11 and 13 of this Regulation. To this end, any authorised representatives of the Commission shall have the following rights and powers: (a) to check the books and other business records of undertakings; (b) to take copies or extracts of such books and records on the spot; (c) to be given access to all premises, land and vehicles of undertakings; (d) to require explanations on all points relating to the books and records of undertakings. Authorised representatives of the Commission shall exercise these rights on production of a pass stating that they are empowered to carry out all necessary inspections pursuant to this Article. They must carry a written authority naming the undertaking to be inspected and the purpose of the inspection. Details of the written authority and of the status of the persons responsible for carrying out the inspection shall be duly notified beforehand to the Member State concerned. Officials of that State may, at the request either of the latter or of the Commission, assist the authorised representatives of the Commission in the performance of their duties. If any undertaking refuses inspection as provided for in this Regulation, the Member State concerned shall give the authorised representatives of the Commission such support and assistance as may be necessary for the purpose of carrying out their inspections as instructed. Member States shall introduce the necessary measures for this purpose before 1 July 1961, after consulting the Commission. 3. All persons taking part in inspections as provided for in this Article shall observe professional secrecy, in accordance with Article 214 of the Treaty. Article 15 1. Without prejudice to measures taken under Article 79 (4) of the Treaty, the Commission and Member States shall ensure that all facts made known to them in pursuance of Articles 5, 11, 13 and 14 remain confidential. 2. Unless the Council unanimously decides otherwise, information so obtained may only be used for the implementation of this Regulation. Article 16 After consulting the Commission, Member States shall, within the time limit laid down in Article 14 (1), lay down appropriate penalties for: (a) carriers who fail to comply with the rules laid down in Articles 5 (2) and 6; (b) undertakings which, having been required to do so, fail to submit to their Governments within the time limit laid down, the information specified in Articles 11 and 13; (c) undertakings which knowingly submit false information to their Governments. Article 17 1. If such an undertaking as aforesaid fails to submit the information requested by the Commission under Articles 11 and 13 within the time limit laid down, or if it knowingly supplies false information, the Commission may, in accordance with the second subparagraph of Article 79 (3) of the Treaty, take a decision imposing a penalty of not more than 500 units of account on the undertaking concerned and may specify a fresh date for submission of the required information. If that undertaking fails to supply the information by the fresh date, the decision may be repeated. 2. However, such penalties may be imposed only if the request for information has been presented in the form of a decision referring expressly to the penalties provided for in this Article. Article 18 1. If the Commission is satisfied that there is discrimination within the meaning of Article 79 (1) of the Treaty, it may, in respect of each case of discrimination and taking a decision as provided for in Article 79 (4), impose on the carrier responsible a penalty not exceeding twenty times the carriage charge obtained or demanded. 2. If discrimination within the meaning of Article 79 (1) of the Treaty continues despite a decision by the Commission ordering that such discrimination be ended, the Commission may impose on the carrier responsible, in respect of each case of discrimination and in accordance with Article 79 (4) of the Treaty, a penalty not exceeding 10 000 units of account. 3. Before imposing a penalty under Article 17 of this Regulation, the Commission shall consult all Member States concerned, which shall be supplied with copies of all documents and evidence assembled in connection with the investigation conducted by the Commission under Article 79 (4) of the Treaty. Each Member State consulted may seek the opinion of an independent national body and shall reply within two months. Article 19 Decision taken under Articles 17 and 18 of this Regulation shall not be of a criminal law nature. Article 20 Before any decision is taken in pursuance of Articles 17 and 18, the undertaking concerned shall be notified of the measure proposed. The Commission shall, by way of information, forward copies of decisions taken under Articles 17 and 18 to the Member States concerned. Article 21 For the purposes of the preceding Articles, the unit of account shall be that used for drawing up the budget of the Community, as provided in Articles 207 and 209 of the Treaty. Article 22 All undertakings, whether governed by public or by private law, shall be responsible for the acts of their servants as regards compliance with the provisions of this Regulation. This provision shall also apply as regards the penalties laid down in this Regulation. Article 23 Penalties imposed by the Commission under Articles 17 and 18 shall be enforced in the manner laid down in Article 192 of the Treaty. Sums collected in enforcement of decisions imposing penalties shall be paid over to the European Economic Community and shall be shown as revenue in its budget. Article 24 Where a Member State submits an application under Article 79 (4) of the Treaty requesting investigation of a case which it considers to constitute discrimination, such application shall state the reasons on which it is based. Article 25 1. Before taking a decision or imposing a penalty under Article 18 of this Regulation, the Commission shall hear explanations from the person concerned or his authorised representative; it may appoint one of its officials to hear such explanations. 2. Pursuant to Article 172 of the Treaty, the Court of Justice shall have unlimited jurisdiction in regard to any penalty imposed under Articles 17 and 18. The Commission may not proceed with the enforcement of a penalty until the period allowed for appeal has expired. Article 26 The Commission shall take the measures necessary for the implementation of this Regulation. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 June 1960. For the Council The President P. GRÉGOIRE

Summary: Inland navigation: access to the market Inland navigation: access to the market SUMMARY OF: Regulation (EC) No 169/2009 applying competition rules to transport by rail, road and inland waterway Regulation (EC) No 718/1999 on an EU-fleet capacity policy to promote inland waterway transport Directive 96/75/EC on the systems of chartering and pricing in national and international inland waterway transport in the EU Regulation (EC) No 1356/96 on common rules applicable to the transport of goods or passengers by inland waterway between EU countries with a view to establishing freedom to provide such transport services Regulation (EEC) No 3921/91 laying down the conditions under which non-resident carriers may transport goods or passengers by inland waterway within an EU country Directive 87/540/EEC on access to the occupation of carrier of goods by waterway in national and international transport and on the mutual recognition of diplomas, certificates and other evidence of formal qualifications for this occupation Regulation (EEC) No 2919/85 laying down the conditions for access to the arrangements under the Revised Convention for the navigation of the Rhine relating to vessels belonging to the Rhine Navigation Regulation No 11 concerning the abolition of discrimination in transport rates and conditions, in implementation of Article 79(3) of the Treaty establishing the European Economic Community WHAT IS THE AIM OF THE REGULATIONS AND DIRECTIVES? Regulation (EC) No 169/2009 sets out EU competition rules applying to transport by road, rail and inland waterways. Regulation (EC) No 718/1999, together with amending Regulation (EU) No 546/2014, lays down the rules for a policy on EU fleet capacity. Directive 96/75/EC outlines steps to achieve freely negotiated chartering contracts and pricing in the EU. Regulation (EC) No 1356/96 aims to ensure that operators who transport goods or passengers by inland waterway are free to provide these services between EU countries. Regulation (EEC) No 3921/91 lays down the conditions under which non-EU carriers are free to operate inland waterway transport services in the EU. Directive 87/540/EEC aims to establish uniform access conditions to the occupation of carrier, facilitating mutual recognition of diplomas and other qualifications. Regulation (EEC) No 2919/85 lays down the conditions for accessing arrangements under the Revised Convention for the navigation of the Rhine relating to vessels belonging to the Rhine navigation. EEC Council Regulation No 11 aims to eradicate discrimination in transport rates and conditions. KEY POINTS The legislative framework for the EU inland waterway transport (IWT) includes legislation covering various objectives which together aim at liberalising the IWT transport market by: ensuring that IWT operators have free access to all European inland waterways; abolishing discriminatory and unfair market practices, in particular regarding rates and tariffs; and creating fair conditions of competition through common rules including admission to the occupation of IWT carrier. Regulation (EC) No 169/2009 aims to harmonise EU competition rules on road, rail and inland waterways transport, by defining exemptions from the prohibition of restrictive agreements, decisions or concerted practices that aim to achieve technical improvements or technical cooperation by: standardising equipment; exchanging or pooling staff, equipment, vehicles or fixed installations; fixing and applying inclusive rates for successive, complementary, substitute or combined transport operations, including special competitive rates; using the most rational routes; coordinating transport timetables for connecting routes; grouping single consignments; establishing uniform tariff structures, provided those rules do not lay down rates and conditions. The regulation also exempts certain small and medium-sized enterprises. Regulation (EC) No 718/1999 aims to lay down community fleet policy for IWT in the EU. It covers vessels that transport goods commercially with certain exemptions, inter alia for vessels that operate exclusively on the Danube or for vessels that are used for storing goods or dredging. It requires EU countries with fleet tonnage of over 100,000 tonnes and with waterways connected with other EU countries to set up an inland waterways fund. Each fund shall have a reserve fund with separate accounts for dry cargo carriers*, tankers* and pusher vessels*. These funds are to be administered by national authorities. The reserve fund can be used: in the event of ‘serious market disturbance’ in the IWT market (within the meaning of Directive 96/75/EC, see below) at the request of an EU country; orif unanimously requested by the organisations representing IWT. Regulation (EC) No 181/2008 sets out the practical arrangements for implementing the EU fleet capacity policy, including the rate of the contributions to the fund. Amending Regulation (EU) No 546/2014 extends the scope of the measures available under Regulation (EC) No 718/1999. Directive 96/75/EC includes two sets of policy measures: to achieve freely negotiated chartering contracts and pricing in the EU by transitioning from the previous system of ‘chartering by rotation’ for transport operations (at previously fixed prices based on the order in which vessels become available after unloading); to allow the European Commission to take action in the event of serious disturbance of the IWT market including, in particular, measures designed to prevent any new increase in the transport capacity. Regulation (EC) No 1356/96 aims to ensure that operators who transport goods or passengers by inland waterway are allowed to carry out transport operations between EU countries and to transit through them without discrimination on grounds of nationality or place of establishment, if they: are legally established in an EU country and are entitled in that country to carry out international transport of goods or passengers by inland waterway and use vessels which are registered in an EU country; satisfy the conditions of Regulation (EEC) No 3921/91. Special rules on the rights of operators from non-EU countries exist under the Revised Convention for the Navigation of the Rhine (Convention of Mannheim) and the Convention regarding the Regime of Navigation on the Danube (Belgrade Convention), or may arise from other international agreements or treaties to which the EU is a party. Regulation (EEC) No 3921/91 builds upon the general principles of equality of treatment and freedom to provide services, whereby non-resident carriers should be allowed to carry out national transport services (‘cabotage’) on inland waterways in the EU. It lays down the following conditions: carriers may temporarily carry out cabotage services, without having to set up a registered office, provided that they are established in an EU country in accordance with its legislation and that they are entitled to transport goods or persons internationally by inland waterway; carriers may only use vessels owned by: EU residents or EU-country nationals, orlegal persons with their registered office in an EU country and in which EU-country nationals hold a majority interest. Directive 87/540/EEC requires that individuals and undertakings possess competences recognised by the authorities or by a body appointed by each EU country in the following areas: law; commercial and financial management of an undertaking; access to the market; technical standards and technical aspects of operation; safety; and international transport operational issues. The authority will issue a certificate on the basis of a diploma, attendance at a course or proven practical experience. If the carrier no longer meets the conditions, the certificate may be withdrawn. Regulation (EEC) No 2919/85. The Revised Convention for the Navigation of the Rhine (amended by Additional Protocol No. 2) stipulates that only vessels belonging to the Rhine navigation are authorised to navigate on the Rhine. A vessel belongs to the Rhine if it carries a document issued by a competent authority of a Rhine country (i.e. Belgium, France, Germany, the Netherlands and Switzerland). The regulation extends the application of the convention to all EU countries, thereby ensuring the equal treatment of vessels from throughout the EU. EEC Council Regulation No 11/1960 aims to implement Article 79(3) of the Treaty of Rome (now Article 95 of the Treaty on the Functioning of the European Union). The regulation: prohibits any discrimination by carriers — in the form of charging different rates and imposing different conditions for carrying the same goods over the same transport links — on the grounds of the country of origin or of the destination of the goods in question; covers the carriage of all goods by several modes of transport, be it by rail, road or inland waterways; sets rules on documentation requirements for transport documents; requires EU countries to check compliance with the obligations. FROM WHEN DOES THE LEGISLATION APPLY? Regulation (EC) No 169/2009 has applied since 25 March 2009. Regulation (EC) No 718/1999 has applied since 29 April 1999. Directive 96/75/EC has applied since 30 November 1996 and had to become law in the EU countries by 1 January 1997. Regulation (EC) No 1356/96 has applied since 2 August 1996. Regulation (EEC) No 3921/91 has applied since 5 January 1992. Directive 87/540/EEC has applied since 12 November 1987 and had to become law in the EU countries by 30 June 1988. Regulation (EEC) No 2919/85 has applied since 22 October 1985. Regulation No 11/1960 has applied since 5 September 1960. BACKGROUND For more information, see: Inland waterways (European Commission). KEY TERMS Dry cargo carriers: vessels that carry dry cargo (e.g. grains). Tankers: vessels that carry wet cargo (e.g. oil). Pusher vessels: vessels that serve to push other vessels such as barges but do not themselves carry cargo. MAIN DOCUMENTS Council Regulation (EC) No 169/2009 of 26 February 2009 applying rules of competition to transport by rail, road and inland waterway (Codified version) (OJ L 61, 5.3.2009, pp. 1-5) Council Regulation (EC) No 718/1999 of 29 March 1999 on a Community-fleet capacity policy to promote inland waterway transport (OJ L 90, 2.4.1999, pp. 1-5) Successive amendments to Regulation (EC) No 718/1999 have been incorporated into the original text. This consolidated version is of documentary value only. Council Directive 96/75/EC of 19 November 1996 on the systems of chartering and pricing in national and international inland waterway transport in the Community (OJ L 304, 27.11.1996, pp. 12-14) See consolidated version. Council Regulation (EC) No 1356/96 of 8 July 1996 on common rules applicable to the transport of goods or passengers by inland waterway between Member States with a view to establishing freedom to provide such transport services (OJ L 175, 13.7.1996, pp. 7-8) Council Regulation (EEC) No 3921/91 of 16 December 1991 laying down the conditions under which non-resident carriers may transport goods or passengers by inland waterway within a Member State (OJ L 373, 31.12.1991, pp. 1-3) Council Directive 87/540/EEC of 9 November 1987 on access to the occupation of carrier of goods by waterway in national and international transport and on the mutual recognition of diplomas, certificates and other evidence of formal qualifications for this occupation (OJ L 322, 12.11.1987, pp. 20-24) Council Regulation (EEC) No 2919/85 of 17 October 1985 laying down the conditions for access to the arrangements under the Revised Convention for the navigation of the Rhine relating to vessels belonging to the Rhine Navigation (OJ L 280, 22.10.1985, pp. 4-7) EEC Council: Regulation No 11 concerning the abolition of discrimination in transport rates and conditions, in implementation of Article 79 (3) of the Treaty establishing the European Economic Community (OJ 52, 16.8.1960, pp. 1121-1126) See consolidated version. RELATED DOCUMENTS Consolidated version of the Treaty on the Functioning of the European Union — Part Three — Union policies and internal actions — Title VI — Transport — Article 95 (ex Article 75 TEC) (OJ C 202, 7.6.2016, p. 86) Commission Regulation (EC) No 181/2008 of 28 February 2008 laying down certain measures for implementing Council Regulation (EC) No 718/1999 on a Community fleet capacity policy to promote inland waterway transport (Codified version) (OJ L 56, 29.2.2008, pp. 8-12) last update 22.12.2020