The hygienic design of food machinery: Supply of Machinery (Safety) Regulations 2008
OC 520/22 rev3
This combined Local Authority and HSE Operational Guidance (LAC/OG) 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 describes the action public authorities should take if they have significant concerns about the hygienic design of such machinery.
Legal requirements for hygienic design of food machinery
1. All machinery placed on the market since 1995 has had to meet the requirements of the Supply of Machinery (Safety) Regulations (2008 and its predecessors), which includes safety by design, affixing the appropriate conformity marking, and the provision to the end user of a Declaration of Conformity and suitable Instructions for Use in English. In addition to the usual guarding and control systems etc. requirements, the Regulations require machinery used for food (and pharmaceuticals and 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:
- they can be cleaned before each use and can be easily dismantled for cleaning where necessary;
- materials coming into contact with food satisfy certain conditions as to suitability and surfaces in contact with food are smooth, have minimum edges, recesses etc.;
- cleaning or disinfecting chemicals can be completely discharged from the machine;
- insects, organic matter etc. cannot accumulate in areas that cannot be cleaned;
- machine lubricants etc cannot come into contact with foods.
In addition, instructions must be provided to indicate recommended cleaning products and methods for cleaning, disinfection and rinsing.
For more detail see chapter 2.1 of part 1 of schedule 2 of the Supply of Machinery (Safety) Regulations 2008 and the guidance at §277 on Hygiene requirements for machinery intended for use with foodstuffs or with cosmetics or pharmaceutical products in the European Commission Guide to application of the Machinery Directive 2006/42/EC 2nd Edition.
2. Under the Supply of Machinery (Safety) Regulations 2008 (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.
Concordat between HSE and Food Standards Agency (FSA)
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:
- HSE and FSA keep each other informed on topics of common interest, give consideration to each other's views and communicate effectively;
- HSE and FSA exchange information and liaise regarding advice to LA inspectors involved in enforcement of food safety issues;
- FSA provides HSE with advice and information on hygiene design aspects of food processing machinery;
- FSA may provide LAs with advice on the hygienic construction of equipment in relation to LAs food safety enforcement function.
- The FSA has overall policy responsibility for food hygiene and safety and has lead responsibility for hygiene design aspects of machinery;
- The FSA will provide technical assistance, advice, information and support to HSE including expert evidence if legal proceedings are necessary;
- The FSA will prepare guidance on the application of hygiene design for users and manufacturers, in consultation with HSE;
- The FSA will give guidance to Local Authority EHOs on SMR requirements, and on their role in HSE's enforcement of SMR and the procedures to be followed;
- The FSA working with HSE's General Manufacturing Sector team, will participate, as necessary, in preparing CEN standards giving guidance on meeting the hygiene design requirements of the Machinery Directive;
- The FSA will be involved, via the usual hygiene communication routes, if a food poisoning outbreak occurs which is attributable to unhygienic design of machinery (HSE should not be involved unless FSA believe enforcement action on hygienic design matters is appropriate);
- The FSA accepts that HSE should be free to choose the priority it gives to enforcement of the Regulations and its policy on their enforcement (similarly HSE accepts that the FSA should be free to choose the priority it gives to the provision of technical assistance, advice and information to HSE, and its policy on these matters).
FSA: Reducing the risks from E. coli 0157: Controlling cross contamination
5. As a result of an outbreak of E. coli 0157 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 0157, and how those delivering official controls can gain assurance that food business controls are adequate and effective". The consultation document said that "E. coli 0157 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 0157 from raw meat in butcher's premises".
6. Guidance on E. Coli 0157 Control of Cross-Contamination is available from the FSA 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."
Inspection and enforcement at food premises
7. 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 policy is that its 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:
8. HSE inspectors should, using the checklist, complete with as much detail as possible part 1 of the Product Safety Request form and send the completed form to the Product Supply Officer (PSO) for their local HSE Product Safety Team (PST). In most cases other information such as photographs, measurements and documents will be required.
9. EHOs should, in consultation with their usual HSE Enforcement Liaison Officer (ELO) and assisted by the checklist, also complete part 1 of the same Product Safety Request form. In most cases other information such as photographs, measurements and documents will be required. The completed request form should be sent with the other supporting information by email to the (ELO) contact for forwarding to the relevant Product Safety Team.
Action by HSE's Product Safety Teams (PSTs)
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 Supply of Machinery (Safety) Regulations 2008, 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 under the HSE/FSA Concordat (see paras 4 and 5), with the involvement of the General Manufacturing Sector. HSE's Product Safety teams have details of the single point of contact for liaison with the FSA.
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:
- HSE's web pages on food processing and packaging machinery, including food hygiene
- the European Commission Guide to application of the Machinery Directive 2006/42/EC, which also covers the links with other relevant legislation concerned with materials that may be in contact with foodstuffs.
13. Detailed technical guidance on hygienic design of food machinery:
- BS EN: 1672-2:2005: +A1:2009 Food Processing Machinery - Basic Concepts Part 2: Hygiene Requirements which is a revision of the earlier 1997 version. If followed in full by a machine manufacturer this Harmonised European Standard gives presumption of conformity with the relevant Essential Health and Safety Requirement of the Supply of Machinery (Safety) Regulations 2008 (EHSR 2.1, Annex 1, Part 1, Schedule 2).
- An ISO standard has also been developed to cover hygienic design for all industries. The latest version BS EN ISO 14159: 2008 :Safety of Machinery - Hygiene Requirements for the Design of Machinery was published in June 2009.
- Other food and packaging machinery specific standards dealing with classes of food preparation machinery, eg bakery, meat and catering, may contain class-specific guidance on hygienic design requirements.
All standards are available from BSI.
14. For HSE staff, the General Manufacturing Sector team will 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.