Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene

(2017/C 163/01)

CONTENTS

1.   INTRODUCTION

According to the 2014 Zoonosis Monitoring Report (1), the majority of verified outbreaks in the EU were associated with foodstuffs of animal origin. Fruit and vegetables were implicated in only 7,1 % of the verified outbreaks, primarily caused by frozen raspberries contaminated with Norovirus, albeit showing an increase compared to 2013 where ‘vegetables and juices’ were reported in 4,4 % of the outbreaks. Nevertheless, the possible consequences of microbiological contamination of fresh fruits and vegetables (FFV) cannot be underestimated as shown by the German crisis (2) linked to the contamination of sprouts by Verotoxin-producing Escherichia coli (VTEC).

In the aftermath of this VTEC crisis in 2011, the Commission asked the European Food Safety Authority (EFSA) to advice on the public health risks posed by pathogens in food of non-animal origin (FNAO), addressing in particular the risk factors and the mitigation options including possible microbiological criteria. As a result, EFSA issued six scientific opinions on the following food/pathogen combinations identified as the most important risks within FNAO:

This guideline takes account of the relevant opinions of EFSA, and consultation with Member States experts and relevant stakeholders. Though it is intended to offer practical help to growers, it may also be used by official inspectors during their audits where appropriate. EFSA confirmed that further research on possible risks and risk mitigating measures related to FFV should continue.

2.   OBJECTIVES OF THE GUIDANCE DOCUMENT

The purpose of this guidance document is to assist growers (regardless of size) at primary production to apply in a correct and uniform way hygiene requirements related to production and handling of FFV. It will provide guidance to growers on how to address microbiological food safety hazards through good agricultural practices (GAP) and good hygiene practices (GHP) in primary production (i.e. growing, harvest and post-harvest) of FFV sold to consumers raw (unprocessed) or minimally processed (i.e. washed, sorted, packed), including during transportation provided that these activities do not substantially alter their nature as laid down in the definition of Annex I of Regulation (EC) No 852/2004 (4). These activities are hereafter referred to as ‘associated operations’. These good practices should be implemented throughout the primary production chain.

Implementation of this guidance should be considered a priority for any FFV eaten raw and, wherever possible, be aimed at for FFV eaten cooked.

3.   SCOPE AND USE

This Guidance covers the good hygiene practices (GHP) and good agricultural practices (GAP) involved in the production of fresh fruit and vegetables at the primary production level, including associated operations, with the purpose to control microbiological pathogens causing gastrointestinal illness due to the consumption of FFV (5) (e.g. pathogenic E.coli, Hepatitis A virus, Listeria…).

Additional specific guidance for certain produce is included where appropriate (6). As specific EU guidance for good hygiene practice in the production of sprouts and seeds for sprouting (7) is being prepared by the European Sprouted Seeds Association, the production of this category is not further addressed in this guidance.

This guidance document gives guidance as to how to apply the general hygiene requirements in the case of FFV. It should be used in conjunction with other applicable guidance documents. The European FFV industry being very diverse, though the categories of FFV considered hereafter are produced under diverse environmental conditions within the EU Member States and thus some provisions of this guidance might be adjusted to suit small farms, or traditional farming areas, the general hygiene requirements laid down in Annex I of Regulation (EC) No 852/2004 must always be fulfilled.

4.   EU LEGISLATION APPLICABLE

This guidance is specifically dedicated on how to address microbiological hazards. All growers must comply with the relevant EU regulations associated to the practices described in this guide. For a complete understanding, it is essential to recall the most relevant EU legislation for good practices at the primary production of fresh fruit and vegetables.

4.1.   Related to General Hygiene rules

4.2.   Related to specific EU rules

In addition, there are national legislations/standards in place in some Member States (17) regarding the quality of reclaimed water.

Complementary EU hygiene guides are available at DG Sante website/food safety issues. At international level, further information is also available in the Codex Alimentarius codes of hygienic practices relevant for FFV (18).

5.   MAIN RISK FACTORS FOR MICROBIOLOGICAL PATHOGENS IN FRESH FRUITS AND VEGETABLES IDENTIFIED BY EFSA

Flowchart No 1

6.   CHECK LISTS FOR HYGIENE INSPECTIONS OF FFV AT PRIMARY PRODUCTION LEVEL

The example check lists (No 1 to 7) below illustrate the hygiene obligations per risk category (as identified by the EFSA opinions), which any grower can use to check if he fulfils EU hygiene requirements. In addition, these checklists can help growers put in place appropriate recommendations provided in Chapters 6 and 7 of this guide.

Check list No 1: Outcome of official controls and appropriate remedial action

Check list No 2: Environmental factors and location of the production site

Environmental factors including animal reservoirs are a potential source of contamination of FFV and these risks should be prevented or at least mitigated. In case the analysis signalled a contamination of land, check list No 2 can help growers identify the source of contamination and take the relevant actions to fulfil EU requirements and appropriate recommendations.

Check list No 3: Fertilisers

Check list No 4: Water for primary production and associated operations at the place of such production

Check list No 5: Hygiene and health status for agricultural workers

Check list No 6: Hygiene conditions during associated activities at farm level

Check list No 7: Record keeping and withdrawal/recall procedures

7.   GOOD AGRICULTURAL AND HYGIENE PRACTICES

FFV are grown and harvested under a wide range of climatic conditions and diverse geographical settings. They can be grown in cropping sites indoors (e.g. greenhouses) and outdoors, harvested, and either field-packed or transported to a packing establishment. Production practices, growth conditions and the location of the edible part during growth (soil, soil surface, aerial part) in combination with intrinsic, extrinsic, harvesting and processing factors will affect the final microbiological status of FFV at the time of consumption. It has been shown that microbiological food safety hazards and sources of contamination vary considerably from one type of FFV production to another and from one particular setting/context to another, even for the same FFV. These different factors can be addressed within good agricultural practices and good hygiene practices.

Examples and recommendations on how to implement all the obligations corresponding to Annex I (primary production) of Regulation (EC) No 852/2004 can be found later in this document.

7.1.   Control of environmental factors and location of the cropping site

7.1.1.   General principles

Assessment of environmental risk factors in and around the FFV cropping area (e.g. to identify potential sources of microbiological contamination) is particularly important because subsequent steps may not be adequate to remove contamination that occurs during production and in some cases may lead to conditions that enable the growth of microbiological pathogens.

7.1.2.   EU Obligations set in Regulation (EC) No 852/2004

(Annex I — Part A — II.2) ‘As far as possible, food business operators (FBO) are to ensure that primary products are protected against contamination, having regard to any processing that primary produce will subsequently undergo’.

(Annex I — Part A — II.3 (a))‘…FBO are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including measures to control contamination arising from the air, soil, water, feed, fertilisers, plant protection products and biocides and the storage, handling and disposal of waste.’

(Annex I — Part A — II.5 (e)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate, as far as possible to prevent animals and pests from causing contamination.’

7.1.3.   Good practice recommendations

7.2.   Control of fertilisers (organic)

7.2.1.   General principles

The nature of agricultural inputs is very diverse and can include organic fertilisers (e.g. livestock manure, slurries, and sewage sludge) or inorganic fertilisers (chemical fertilisers). Fertilisers should only be applied in sufficient amounts to meet FFV needs. Since the focus of this guide is on microbiological food safety hazards, inorganic fertilisers are not further considered  (27).

Organic fertilisers are widely and beneficially applied to meet FFV nutrient requirements and improve soil fertility but their incorrect use can be a source of both microbiological (e.g. Salmonella spp., VTEC, Norovirus) and chemical contamination (e.g. heavy metals). Pathogens may be present in manure and other natural fertilisers and may persist for weeks or even months, particularly if treatment of these materials is inadequate.

Physical, chemical or biological treatment methods (e.g. composting (28), pasteurization, heat drying, UV irradiation, alkali digestion, sun drying or combinations of these) may be used to reduce the risk of potential human pathogen survival in manure, sewage sludge and other organic fertilisers.

Organic fertilisers should not therefore contain microbial, physical or chemical contaminants at levels that may adversely affect the safety of FFV and their use must comply with the relevant EU regulations and take account of WHO guidelines on the safe use of wastewater and excreta in agriculture, as appropriate.

7.2.2.   EU Obligations set in Regulation (EC) No 852/2004 and in Directive 86/278/EEC

(Annex I — Part A — II.2) ‘As far as possible, food business growers are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.’

(Annex I — Part A — II.3 (a)) ‘Food business growers are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste.’

(Annex I — Part A — II.5 (f)) ‘Food business growers producing or harvesting plant products are to take adequate measures, as appropriate to store and handle wastes and hazardous substances so as to prevent contamination.’

(Council Directive 86/278/EEC) ‘The use of sewage sludge in the production of fruits and vegetables must comply with EU and national requirements. In certain situations, sludge may not be used at all in farming, i.e. on fruit and vegetables (FFVs) during the growing season (with the exception of fruit trees) and on soil used to grow fruit and vegetable FFVs that are usually in direct contact with the soil and eaten raw. This ban applies for 10 months before the harvest and during the harvest itself’.

7.2.3.   Good practice recommendations

7.2.3.1.   General recommendations

7.2.3.2.   Treated manures (e.g. solid manures, slurries)

7.2.3.3.   Untreated or partially-treated manures/other organic fertilisers

7.2.3.4.   Sewage sludge treatment and application

7.2.3.5.   Specifications for production and use of anaerobic digestates and composts (34)

7.2.3.6.   Due diligence when using organic fertilisers purchased from the market

Growers buying livestock manure, sewage sludge and other organic fertilisers from the market should select a reputable supplier and obtain documentation that identifies the origin, treatment applied, and results of all tests (including for microbiological and chemical contaminants) carried out on the final product.

Table 1 gives an example of pre-harvest intervals that should be followed when growers use organic fertilisers.

Table 1:

7.3.   Control of water for primary production and associated operations at the place of such production (harvest and post-harvest)

Several factors linked to the use of water in agriculture may influence the risk of microbial contamination of the FFV, such as: source of water, type of irrigation (drip, sprinkler irrigation, etc.), whether the edible portion of the FFV has direct contact with irrigation water, application of a water treatment by the grower, the timing of irrigation in relation to harvesting, possible access of animals to the source, etc. Another important issue to consider is the stage in the food chain: e.g. can a possible contamination still be eliminated or reduced by e.g. drying out (sun irradiation in the field), washing, etc. Ready-to-eat foods and foods closer to the point of consumption will require water of higher quality.

7.3.1.   General principles

In agricultural practices different sources and quality of water are used for pre-harvest, harvest and post-harvest activities (all together called ‘agricultural water’ — see Flowchart No 2), with each of these having a different effect with regard to microbiological contamination of FFVs. Water of inadequate quality has the potential to be a direct source of contamination and a vehicle for spreading localised contamination in the field, facility, or during transport. Wherever water comes in contact with fresh produce, its quality impacts the potential for pathogen contamination. If pathogens survive on the produce, they may cause foodborne illness. Most associated pathogens related to transmission via water of low quality are enteric bacteria, e.g. Salmonella spp., Campylobacter spp., VTEC and viruses, e.g. Norovirus. E. coli is typically used as an index organism to faecal contamination and elevated levels of E. coli may indicate a higher potential for presence of pathogens.

In addition to the recommendations on water control described in this section, the following should also be considered:

Flowchart No 2: Summary of diversity of types of agricultural water and agricultural practices in EU production of (ready-to-eat) FFV

7.3.2.   EU Obligations set in Regulation (EC) No 852/2004

(Annex I — Part A — II.3 (a)) ‘…FBO are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including measures to control contamination arising from air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste’.

(Annex I — Part A — II.5 (c)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate, to use potable water, or clean water, whenever necessary to prevent contamination’.

7.3.3.   Practical tools to assess the source and the intended use of agricultural water

A risk assessment should be carried out considering the source and the intended use of agricultural water (e.g. irrigation system, FFV characteristics, intended use of FFV…), defining the suitability for agricultural purposes, the recommended microbiological threshold values and the frequency of monitoring as described in Annex II of this guidance document.

For guidance on performing a water risk assessment growers can refer to the approach illustrated in the flowchart No 3 which helps to identify the possible contamination sources of the water at primary production of FFV. This applies to both, irrigation water and water used for associated operations (e.g. pesticide application, fertigation, washing etc.).

A more simplified and quick approach may be to use a ‘decision tree’ such as the one in Annex III of this guidance document, where the outcome takes into account a limited number of sampling recommendations compared to those contained in Annex II.

Both tools may be used to take decisions based on the risk profile of agricultural water, but as the two approaches are different, the results cannot be comparable or extrapolated.

Steps that any grower could use to identify possible contamination sources via water at primary production of FFV are summarised in the flowchart No 3 below.

Flowchart No 3: Practical way for the risk assessment of agricultural water

A practical way to carry out the risk assessment of agricultural water in flowchart No 3 is to complete the following table.

Table 2: Application of the general principles of preventing microbiological contamination via water used during agricultural activities

In order to comply with the EU obligations (see Section 7.3.2), the results of this risk assessment will help by defining the extent to which GHP should be applied (7.3.3) including recommendations on the analyses of the water for agricultural use.

7.3.4.   Good practice recommendations

7.3.4.1.   General recommendations for source, storage and distribution of water

7.3.4.2.   Good practice recommendations regarding irrigation methods

7.3.4.3.   Good practice recommendations regarding the water used during harvest and post-harvest (associated operations)

7.3.4.4.   Additional good practice for leafy greens, tomatoes, melons (52)

7.3.4.5.   Good practice recommendations as regards analyses of water for agricultural use

7.4.   Hygiene and health status for agricultural workers

7.4.1.   General principles

All workers should be aware of the basic principles of hygiene and health, and should be informed about all the possible risks related to the contamination of the product. They should receive hygiene training appropriate to their tasks and be periodically assessed. Such training should be delivered in a language and manner to ensure understanding of the required hygienic practices.

In general unauthorised visitors should be excluded from food production and handling areas. The visitors should complete a health screening questionnaire prior to admission and, where appropriate, wear protective clothing and adhere to the staff hygiene provisions of the food business. Whenever possible, harvesting, packing and inspection processes should be designed to reduce handling.

Each grower should put in place illustrated and easy to read documentation (55) related to health status, good hygiene practices, staff training and sanitary facilities, to ensure staff, contractors and visitors are aware of, and follow GHP at all times.

7.4.2.   EU Obligations set in Regulation (EC) No 852/2004

(Annex I — Part A — II.5 (d)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate to ensure that staff handling foodstuffs are in good health and undergo training on health risks.’

7.4.3.   Good practice recommendations

7.5.   Control of hygiene conditions during associated activities at farm level in addition to those described in Chapters 7.3 and 7.4

7.5.1.   General principles

Harvesting methods vary depending upon the characteristics of the product. Mechanical harvesting is a common practice for some FFV and reduces the cross-contamination events that might occur during manual harvest. But if such equipment breaks down during the harvest, or it has been poorly maintained, inadequately cleaned/disinfected, or if it damages the harvested plant, it can cause spread of microbial contamination and/or conditions that support microbial growth (i.e. damaged FFV).

FFV should be stored and transported under good hygienic conditions. Storage facilities and vehicles for transporting the harvested FFVs should be constructed in a manner that will minimise damage to FFV and prevent access by pests such as insects, rodents and birds. Design and lay-out of facilities should be such as to ensure there is no risk of microbiological, chemical or physical cross-contamination. The level of risk of cross-contamination in relation to product flow within facilities should be considered and addressed at all steps (i.e. arrival of the raw-material, prewash trimming and packaging through to storage and shipping.

7.5.2.   EU Obligations set in Regulation (EC) No 852/2004

(Annex I — Part A — II.5(a)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles.’

(Annex I — Part A — II.5(b)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate to ensure, where necessary, hygienic production, transport and storage conditions for and the cleanliness of plant products.’

(Annex I — Part A — II.5(f)) ‘FBO producing or harvesting plant products are to take adequate measures, as appropriate to store and handle wastes and hazardous substances so as to prevent contamination.’

7.5.3.   Good practice recommendations as regards harvesting and packaging operations at field or at farm level

7.5.3.1.   For all establishments

7.5.3.2.   Additional specific good practice recommendations for growers of tomatoes, berries, melons and watermelons

7.5.4.   Good practice recommendations as regards operations of loading/transport/storage and cleaning/disinfection operations

7.5.4.1.   At farm, packing and transport level

7.5.4.2.   Cleaning, maintenance and disinfection operations

7.5.4.3.   Additional good practice recommendations in relation to storage and packing facilities for growers of tomatoes, berries, melons/watermelons and leafy greens.

8.   RECORD KEEPING AND RESPONSIBILITIES FOR FOOD RECALLS/WITHDRAWALS

8.1.   Record keeping

8.1.1.   General principles

An effective traceability system (back and forward) should be documented to indicate the source of a product and a mechanism for marking or identifying the product that can trace the product from the farm. The grower may be assisted by other persons, such as farm technicians, with the keeping of records.

This information should be made available to the competent authorities on request, as well as the food business operators taking delivery of the harvested products.

8.1.2.   EU Obligations set in Regulation (EC) No 852/2004

(Annex I — Part A — III. 7): Food business growers are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business growers are to make relevant information contained in these records available to the competent authority and receiving food business growers on request.

(Annex I — Part A — III. 9 (a) to (c)): Food business operators producing or harvesting plant products have, in particular, to keep records on:

8.1.3.   Good practice recommendations

8.2.   Responsibilities for food recalls/withdrawals

8.2.1.   EU Obligations set in Regulation (EC) No 178/2002 — Articles 14, 18, 19

(Article 14(1)) ‘Food shall not be placed on the market if it is unsafe.’

(Articles 14(2) and (6)) Unsafe food is defined as ‘food that is injurious to health and/or unfit for human consumption’ and ‘Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe.’

(Article 18(2)) ‘Food business operators shall be able to identify any person from whom they have been supplied with a food or any substance intended to be, or expected to be, incorporated into a food (…). To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand’.

(Article 18(3)) ‘Food business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand.’

(Article 18(4)) ‘Food which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions’.

(Article 19(1)) ‘If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection’.

(Article 19(3)) ‘A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Growers shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food.’

(Article 19(4)) ‘Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.’

8.2.2.   Good practice recommendations

(1)  The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2014, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2015.4329/pdf

(2)  http://ec.europa.eu/dgs/health_consumer/dyna/consumervoice/create_cv.cfm?cv_id=740

(3)  As follow up of this EFSA Opinion, 4 specific regulations have been adopted: Commission Regulations (EU) No 208/2013, (EU) No 209/2013, (EU) No 210/2013 and (EU) No 211/2013 of 11 March 2013 on traceability requirements, on approval, on microbiological criteria, and on certification requirements for imports into the Union of sprouts and seeds intended for the production of sprouts.

(4)  For example, modified atmosphere packaging, or peeling or shredding to smaller pieces used for fresh minimally processed fruits and vegetables are not within scope of Annex I.

(5)  Mycotoxins are excluded from the scope of this guide, as it is based on EFSA opinions related to microbiological pathogens.

(6)  Leafy greens eaten raw as salads, berries, tomatoes, melons and bulbs/stem vegetables and carrots.

(7)  See definition of sprouts in Article 2 of Commission Implementing Regulation (EU) No 208/2013 on traceability requirements for sprouts and seeds intended for the production of sprouts. Sprouted seeds fall under the scope of Annex I of Reg. 852/2004 (Primary production) (OJ L 139, 30.4.2004, p. 1).

(8)  OJ L 31, 1.2.2002, p. 1.

(9)  OJ L 139, 30.4.2004, p. 1.

(10)  OJ L 338, 22.12.2005, p. 1.

(11)  OJ L 70, 16.3.2005, p. 1.

(12)  OJ L 181, 4.7.1986, p. 6.

(13)  OJ L 330, 5.12.1998, p. 32.

(14)  OJ L 375, 31.12.1991, p. 1.

(15)  OJ L 300, 14.11.2009, p. 1.

(16)  OJ L 54, 26.2.2011, p. 1.

(17)  DK/HU/PT/RO/SK.

(18)  CAC/GL 79-2012, CAC/RCP 53-2003, CAC/RCP 42-1995, and CAC/RCP 1-1969:

http://www.codexalimentarius.org/standards/list-standards/en/?no_cache=1?provide=standards&orderField=ccshort&sort=asc&num1

(19)  NB: If inorganic fertilisers are used, no need to answer the other questions of this check list as they are not described in this guide.

(20)  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1).

(21)  Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6).

(22)  As described in Chapter 7.4 (paragraph 7.4.3).

(23)  As described in paragraph 7.5.4.2.

(24)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(25)  In line within the requirements of Integrated Pest Management.

(26)  Only edible part is considered here.

(27)  Although this guide deals with organic fertilisers only, the risks associated with using water soluble inorganic fertilisers are covered in the section on water (Chapter 7.3 of the guide).

(28)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive lays down requirements for transformation of animal by-products in the production of organic fertilisers and soil improvers, including some microbiological standards for digestion residues and compost. Manure produced and used on the same farm may be applied to land without processing if the competent authority does not consider it to be a risk for the transmission of any serious transmissible disease (OJ L 54, 26.2.2011, p. 1).

(29)  I.e. a plan for spreading livestock manure, slurries and organic wastes on the farm. Any plan will help the grower to minimise the risk of causing water pollution. This plan should help to meet national legislative requirements transposing Council Directive 91/676/EEC.

(30)  To protect water against pollution caused by nitrates, the spreading time of treated manures must be done respecting the requirements established by Council Directive 91/676/EEC.

(31)  According to ‘EFSA’s scientific opinion on the risk from Salmonella and Norovirus in leafy greens eaten raw as salads reports’.

(32)  Conventional treated sewage sludge includes lagoon stored, thickened and mesophilic anaerobic digested sludge. Treatment must ensure 99 % of pathogens have been destroyed (a 2 log reduction).

(33)  Enhanced treated sewage sludge includes pasteurisation, thermophilic digestion, lime stabilisation and composting. Treatment must ensure 99,9999 % of pathogens have been destroyed (a 6 log reduction).

(34)  Commission Regulation (EU) No 142/2011 lays down some microbiological standards for digestion residues and compost derived from processing of Animal By-Products, including manure.

(*1)  These pre-harvest intervals are examples of good practice and growers should interpret this guidance according to the risks associated with their particular operation. Factors that affect the rate at which pathogens in fresh manures/slurry die off after application to land include temperature, UV radiation, pH, drying, soil type etc. Other time periods may therefore be justified based on regional differences in climate and environmental conditions etc.

(1)  Where livestock grazing is an essential part of the farming system (e.g. in some organic farms) there should be a minimum 6 months gap between livestock grazing and harvest. To minimise risks further, the guidance in the table above should be followed where practically possible.

(35)  For example BSi PAS 110 or equivalent.

(36)  For example BSi PAS 100 or equivalent.

(37)  Farm manures and slurry should be stored as a batch for a minimum of six months with no additions of fresh manure or slurry during this time. More active forms of treatment include composting (solid manures) and lime treatment (slurry) (see Section 7.2.3.2).

(38)  Conventional treated sewage sludge includes lagoon stored, thickened and mesophilic anaerobic digested sludge. Treatment must ensure 99 % of pathogens have been destroyed (a 2 log reduction).

(39)  Enhanced treated sewage sludge includes pasteurisation, thermophilic digestion, lime stabilisation and composting. Treatment must ensure 99,9999 % of pathogens have been destroyed (a 6 log reduction).

(40)  May have history of pathogen contamination, e.g. whole head lettuce, leafy salads, celery, salad onions, radish, fresh and frozen herbs, etc.

(41)  Target of zero and absolute limit of < 0,1 % (m/m dry weight) glass must be achieved (i.e. limit for glass debris/contamination of the compost or treated manure).

(42)  May have history of pathogen contamination, e.g. apple, beetroot, blackcurrant, blueberry, broad bean, broccoli, cabbage, capsicum, carrot, cauliflower, celeriac, cherry, courgette, cucumber, garlic, green beans (other than runner beans), melon, mushroom, onion (red and white), pea, pear, peach, plum, raspberry, strawberry, sugar snap peas, sweet corn, tomato and tree nuts, etc.

(43)  Target of zero and absolute limit of < 0,1 % (m/m dry weight) glass must be achieved (i.e. limit for glass debris/contamination of the compost or treated manure).

(44)  For example artichoke, leek, marrow, parsnip, potato, pumpkin, runner bean, squash, swede, turnip, etc.

(45)  ISO 16075-2:2015 Guidelines for treated wastewater use for irrigation projects.

(46)  http://www.fao.org/DOCReP/003/T0234e/T0234e00.htm; ftp://ftp.fao.org/docrep/fao/010/a1336e/a1336e07.pdf

(47)  http://apps.who.int/iris/bitstream/10665/78265/1/9241546824_eng.pdf

(48)  When multiple sources or a mixture of water of different sources are applied, conduct the risk assessment for each source used.

(49)  (The definition of processing aids in FFV is harmonised within the EU (Regulation (EC) No 1333/2008), and disinfecting agents have to be approved according to the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 (OJ L 167, 27.6.2012, p. 1) concerning the making available on the market and use of biocidal products. Substances used as processing aids shall be used under conditions of good manufacturing practices (GMP). Some companies use chlorine or other agents to control microbial load in the water. Chlorine in the form of sodium hypochlorite granules, tablets or liquid is the most commonly used as disinfection agent. The quantities of chlorine used should be compatible with the EU maximum level of chlorates that could be found in the final product (see also point 7.3.4.3(d)). In addition, Chlorate is a substance that is no longer approved as a pesticide according to Commission Decision No 2008/865/EC. Since no specific MRL was fixed under Regulation (EC) No 396/2005 on maximum residue levels for pesticides, the default MRL of 0,01 mg/kg is applicable to all food products included in Annex I to that Regulation. The MRLs of Regulation (EC) No 396/2005 are applicable to residues of substances that are currently used or have been formerly used as pesticides. The MRL of 0,01 mg/kg is therefore applicable to chlorate even though most of the current residues arise from uses of chlorine disinfectants as biocides).

(50)  It is the same for pesticides application.

(51)  If the quality of water is not very high, this method of irrigation should only be used during the early stages of growth.

(52)  Categories of fruits and Vegetables evaluated by EFSA Opinions as the most risky categories: produce contaminated by Salmonella/Noroviruses.

(53)  Water samples should be sent to a laboratory for microbial analyses.

(54)  If it is decided to include the proposed microbiological testing frequencies, see the frequencies set up in Annex II, pages 35 to 37.

(55)  Documentation means posters on walls, or leaflets left in visible places, where they can be seen by anyone who enters the establishment.

(56)  E.g. max. 400 m or 5 minutes walking distance.

(57)  E.g. if there are less than 25 workers, one mixed toilet is allowed. If there are more than 25 workers, there should be one toilet for every 20 workers, and separated by gender.

(58)  For example hypochlorites which are not correctly stored may be transformed into an accumulation of chlorates.

ANNEX III

EXAMPLE OF A DECISION TREE TO SUPPORT MICROBIOLOGICAL RISK ASSESSMENT OF AGRICULTURAL WATER

This approach is simplified compared to the one described in Annex II, as the outcome takes into account a limited number of sampling recommendations. It is worth pointing out that results obtained from this decision tree (Annex III) and from the matrix (Annex II) cannot be comparable.

Appendix

The Scope of Regulation (EC) No 852/2004 as regards food of non-animal origin