This combined Local Authority and HSE Operational Circular (LAC/OC) provides information to inspectors and other local authority officials on the interface between HSE, local authorities and other public bodies concerned with the safety of foodstuffs principally arising from the hygienic design and use of machinery for preparing and processing foodstuffs. It updates and replaces the previous HSE OC 520/22 published in 2000 on this topic, and describes the action public authorities should take if they have significant concerns about the hygienic design of such machinery.
1 All machinery placed on the European market since 1995 has had to meet the requirements of the Machinery Directive (2006/42/EC and is predecessors), which includes safety by design, affixing the CE mark, and the provision to the end user of a Declaration of Conformity and suitable Instructions for Use. In addition to the usual guarding and control systems etc. requirements, the Directive requires machinery used for food (and pharmaceuticals & cosmetics) to be ‘designed and constructed in such a way as to avoid any risk of infection, sickness or contagion’. In particular machines must be designed and constructed so that:
In addition, instructions must be provided to indicate recommended cleaning products and methods for cleaning, disinfection and rinsing.
For more detail see clause 2.1 and notes on pages 249-251 in European Commission Guide to the Machinery Directive 2006/42/EC 2nd Edition.
2 The current Machinery Directive was implemented in the UK by the Supply of Machinery (Safety) Regulations 2008 (SMR08), which from 29 December 2009 replaced in full the earlier 1992 SMR regulations and its subsequent amendments (1994 and 2005). Under SMR08 the Health and Safety Executive (HSE) is the enforcing authority for the design, construction and supply of machinery for use at work (Trading Standards deal with non-work use), even though the local authority may be the enforcing authority for the work premises in respect of general health and safety matters.
3 While the design of machinery used at work, for which HSE has the lead, may present food safety risks, local authorities have the responsibility for the protection of public health from risks associated with the preparation, supply or consumption of food. These may include the selection, use and cleaning of machinery for foodstuffs by dutyholders.
4 A formal Concordat between the FSA and HSE was agreed in 2002 which sets out the working arrangements between the two organisations. The Concordat requires (among other things) that:
5 In addition, the Concordat subsumes SMR issues from an earlier Memorandum of Understanding (MoU) between the Department of Health (DoH) and HSE agreed in 2000 before FSA took over responsibilities from DoH. This MoU set out the following principle responsibilities.
DoH (now FSA):
6 As a result of an outbreak of E. coli O157 in Wales in 2005 and the subsequent public enquiry which reported in 2009, the FSA launched a consultation in July 2010 on “the approach to be taken in Agency guidance on how food businesses should control the risk of cross-contamination by E. coli O157, and how those delivering official controls can gain assurance that food business controls are adequate and effective”. The consultation document said that “E. coli O157 is a particularly dangerous organism due to its very low infective dose that can cause serious illness and death, and its ability to survive acidic environments, refrigeration and freezing”. “While not exclusively meat-borne, the fatalities in Scotland (1996) and Wales (2005) were due to cross-contamination of food by E. coli O157 from raw meat in butcher’s premises”.
7 New guidance E. Coli 0157 Control of Cross-Contamination was published by the FSA in February 2011 which states that “Complex equipment such as vacuum packers, slicers and mincing machines should never be used for both raw foods and ready-to-eat foods and separate machines should be provided. These must also be hygienically designed.”
8 Environmental Health Officers (EHOs) and HSE Inspectors are not required to visit food premises specifically to check compliance with hygienic design of machines (HSE’s FOD policy is that HSE’s activity in this area will normally only be reactive). However, during routine work or as a result of investigations, EHOs/HSE inspectors may identify issues of concern such as those highlighted in para.1 above. Where this happens:
9 EHOs should, in consultation with their usual HSE Enforcement Liaison Officer (ELO) and complete part 1 of the Product Safety Request form at annex 2. In most cases other information such as photographs, measurements and documents will be required. (ELO) contact for forwarding to the relevant Product Safety Team.
10 Since 2006 HSE has operated a system of virtual product safety enforcement teams (PSTs) to deal with issues relating to the design and/or supply of unsafe machinery and equipment. These teams also enforce the hygienic design requirements of the Machinery Directive, but in these cases it is essential that the Food Standards Agency (FSA) is involved as it has lead responsibility for hygiene design aspects of machinery.
11 On receipt of a Product Safety Request form the PST will take a decision over the appropriate priority and follow-up action. This decision will be made in consultation with the FSA as under the HSE/FSA Concordat (see paras. 4 and 5), with the involvement of the Food Manufacturing Section of HSE’s Agriculture & Food Sector. The FSA has provided a single point of contact for such liaison: enforcement@Foodstandards.gsi.gov.uk
HSE should not take enforcement action unless FSA believes it is appropriate. Where it is appropriate FSA can provide technical assistance, advice, information and support including expert evidence if legal proceedings are necessary.
12 Basic guidance on the obligations of manufacturers of food machinery:
13 Detailed technical guidance on hygienic design of food machinery:
All standards are available from BSI.
14 The Food Manufacture Section of HSE’s Agriculture and Food Sector may be able to assist with general enquiries on the hygienic design of machinery, and can access further technical assistance within the FSA and, if necessary, from external technical experts in the field of hygienic design.
Products have to meet Essential Requirements, also known as Essential Health & Safety Requirements (EHSRs) in the Machinery Directive. These are listed in the Annexes to the Directives (and repeated in the Schedules of the UK implementing Regulations, see below).
Is the equipment dangerous? What is the level of risk?
If investigating an accident, did the design of the equipment contribute, or was it due to poor maintenance, user modification, or incorrect use?
Has the equipment been modified by the user since it was first supplied in the EU?
Was a Declaration of Conformity (DoC) provided? Is it correct? (Annex II Machinery Directive)
Are all the Instructions and Warning signs in English? (Machinery EHSR 1.7)
Are there detailed cleaning Instructions for machinery handling food, pharmaceutical or cosmetic products? (Machinery EHSR 2.1.2)
Is the equipment CE marked? Is it correct? (Annex 3 Machinery Directive)
Obtain details of any Notified Body. Certain categories of machinery, e.g. as listed in Annex IV of the Machinery Directive, or Schedule 2 Part 4 of SMR08, may have been/need to be assessed by a Notified Body
Is the equipment manufactured to a harmonised European Standard? For machinery handling food do the DoC and/or User Instructions state conformity with EN 1672-2: 2005 Hygiene requirements for food machinery? (or the predecessor EN 1672-2:1997)
To check if a standard is harmonised look at Annex Z of the standard, and also the lists published in the Official Journal, in particular for the latest Machinery Directive 2006/42/EC see:
Who are the manufacturer/importer/supplier?
Is the equipment a one-off, or is it supplied elsewhere in the UK and/or Europe?
Remember! Take copies or photographs of the equipment, certificates, name plate, and relevant extracts of the instructions, also relevant measurements, e.g. sizes of openings and reach distances to danger, so that if the matter is referred for follow-up by the Product Safety Team you have enough information for the Product Safety Request form (PSR1) to enable the matter to be properly considered (or they may come back to you for more).
Recent additions and changes
Making a difference - Judith Hackitt