1. Perspective of a Scottish Local Authority, Enforcers’ challenges and the practical issues with enforcing the Regulations Fiona Hamilton Environmental Health Officer

2. INTRODUCTION Recognition of Sources Legislation and inspection Surveillance of water quality and safety Home/originating authority referrals Food incidents Mineral water, spring water and bottled water guidance. FVO mission visit

3. Natural Mineral Water Producer East Dunbartonshire Council is responsible for carrying out official controls at Campsie Spring who produce mineral water at their site in Lennoxtown, 9 miles north of Glasgow They abstract water from the Campsie hills and the first sources were recognised in 1985 Additional bore holes were sunk and the last source was recognised in 1990 In total 9 separate sources, each with a unique profile are exploited

4. Campsie Spring They are a major mineral water producer in Scotland with an annual output of 152 -156 million litres per year. East Dunbartonshire Council originally were the Home Authority for the company who are now owned by Greencore Plc. We are now the originating authority. The company supply most of the major multiples with ‘own brand’ product. They are subject to third party audits including BRC. As a consequence of changes in their customer base the source and trade names have been changed many times over the years.

5. Legislation The main legislation applicable to bottled water plants are :- The Food Safety Act 1990 (as amended) The Natural Mineral Water, Spring Water and Bottled Water drinking water (Scotland) No.2 Regulations 2007/ EC Regulation 80/777 The General Food Regulations 2004/ EC Regulation 178/2002 The Food Hygiene (Scotland) Regulations 2006/ EC Regulation 852/2004 The Food Labelling Regulations 1996 (as amended)

6. Recognition of Natural Mineral Water Any natural mineral water that is intended to be marketed must be officially recognised by the local authority where the source is to be exploited. All other waters e.g. spring water, do not need official recognition but will still require to comply with relevant legislation. It is the one occasion that you can politely tell a business ‘..I’m sorry no, you can’t start production 2 weeks on Thursday!!’

7. The recognition process In order for an authority to be able to grant recognition they must be satisfied that the water is protected from all pollution both chemical and microbiological In broad terms a potential producer would have to provide the following information to the local authority:- a)Detailed information about the natural mineral water source b)Proof that the natural mineral water meets the microbiological criteria c)Evidence that a natural mineral water is protected from all risk of pollution d)Records of analysis to show that the water is stable

8. The recognition process In order to establish source stability the operator will require to carry out intensive analysis and examination of the source. It is likely the local authority will carry out their own checks to verify the companies lab reports The FSA document ‘The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) No.2 Regulations 2007 – Guidance to the legislation’ recommends that sampling is carried out for a period of two years.

9. The recognition process This time period under certain circumstances may be reduced but analysis should cover all the seasons As a rule of thumb it will take between 1-2 years from conception to production of a natural mineral water In practice the recognition process is much more complex Annex 1 of The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) No.2 Regulations 2007 – Guidance to the legislation gives details on the matters to be considered prior to recognition.

10. Source Recognition Where the local authority decides to recognise a source then they should publish an announcement of recognition in the Edinburgh Gazette The announcement should include the trade name, the name of the spring and the place of exploitation A copy of the announcement should be sent to the FSA in London who will arrange publication of the recognition in the official Journal of the European Communities.

11. Withdrawal and renaming of recognised sources The FSA also maintain lists on their website of U.K Natural Mineral Water suppliers. The lists are also a useful resource to check that an unfamiliar natural mineral water has been officially recognised. Where the recognition is to be withdrawn or renamed the local authority should inform the FSA and publish the withdrawal/renaming in the Edinburgh Gazette In the past 2 years my authority has renamed 6 natural mineral water sources

12. Withdrawal and renaming of recognised sources It is important to check the U.K and European lists to ensure there is no duplication of the names chosen by the producer Published notices can be viewed at www.edinburgh.gazette.co.uk www.edinburgh.gazette.co.uk It is important that the business ensures that all product is sold or removed from sale before the product with a renamed source and/or trade description is put on the market

13. The Food Hygiene (Scotland) Regulations 2006 (as amended) and EC Regulations 852/2004 The Food Hygiene (Scotland) Regulations 2006 apply to bottled water plants in the same way as any other food business Campsie Spring is currently risk rated as a Category D food premises and generally operate to high standards of food hygiene The inspection process is similar to any other factory inspection and we use a generic food hygiene inspection form to record observations

14. The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) no.2 Regulations 2007 and Directive E.C: 80/777 (As amended) During the inspection the results of the companies own checks on the water quality and purity is assessed. This involves review of the companies’ results of Laboratory analysis and examination. An inspection report is issued after every food hygiene inspection. Occasionally checks are undertaken on source security measures.

15. The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) no.2 Regulations 2007 and Directive E.C: 80/777 (As amended) This involves inspecting the natural springs/boreholes on the Campsie hills themselves. A trip on a quad bike is required…..more fun than a day in the office!

16. The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) no.2 Regulations 2007 and Directive E.C: 80/777 (As amended) One of the most important parts of the regulations is the compositional and purity standards specified. To this end we have included the products within our sampling plan. Samples are not usually taken at the time of inspection The company have an onsite laboratory and carry out their own checks and also submit samples to an external laboratory for analysis and examination Sampling is done from the line and the source

17. The General Food Regulations 2004 and E.C Regulations 178/2002 These Regulations amend the Food Safety Act 1990 with regards the sections dealing with fitness of the water for human consumption and consumer protection and are relevant to food hygiene and standards inspections as well as the food surveillance carried out as part of the sampling programme. The Regulations require traceability of product. The recognition process essentially provides this for each source and therefore this requirement relates to date and time of production and to traceability of the contact materials, i.e. bottles and caps.

18. The General Food Regulations 2004 and E.C Regulations 178/2002 Product recall procedures are required by the Regulations. The company have documented procedures in place There has been one product recall since they began production.

19. The Food Labelling (Scotland) Regulations 1996 (as amended) As a labelled product the Food Labelling (Scotland) Regulations 1996 (As amended) apply to the product. Labels are checked for compliance during Food Standards inspections. There are specific labelling requirements contained in The Natural Mineral water, Spring Water and Bottled Water (Scotland) No. 2 Regulations 2007 and EC 80/777 that also have to be considered. They specify detailed labelling requirements e.g. the prominence and font size of the source name, indication of any treatments, statement of the analytical composition etc.

20. The Food Labelling (Scotland) Regulations 1996 ( As amended) The FSA document ‘The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) no. 2 Regulations – Guidance to the Legislation provides details on specific labelling requirements. In practice this requirement should not be particularly onerous as the labels should be checked for compliance at the time of recognition or renaming.

21. Food Standards Inspection Bottled Water producers are subject to Food Standards inspections separately from Food Hygiene inspections. Campsie Spring are currently risk rated as Category B. The company generally comply to a high standard with Food Standards requirements. The inspection includes a review of the companies’ compliance with relevant legislation.

22. Surveillance of Water Quality and Safety Our authority uses Glasgow Scientific Services to carry out analysis and examination of all foods and water samples and they are recognised as an official control laboratory Each specific source is sampled at least once per year. Water from each source is subject to chemical analysis and microbiological examination and this equates to at least 18 samples per year. The level of sampling has resource implications and represents 5% of all programmed samples taken by the food service.

23. Surveillance of Water Quality and Safety Chemical analysis consists of partial analysis against the parameters specified in the Regulations. Full spectrum analysis is not carried out routinely as such analysis is very costly. Microbiological examination consists of testing against all parameters within the Regulations.

24. Surveillance of Water Quality and Safety Historically the source is remarkably stable and no sample failures have occurred. Campsie Spring carry out daily tests on all production and have their own in house lab.

25. Originating Authority Liaison We act as the originating authority for Campsie Spring. Our authority acts as a Liaison body between enforcing authorities where the product is sold and the factory where the water is produced. We enjoy an excellent working relationship with the company and have a good understanding of their operating policies and procedures. We endeavour to provide important information on the company and seek to give assistance to all enforcing authorities who identify potential breaches of relevant food law.

26. Originating Authority Liaison Other authorities can ask for our assistance on any matter e.g. labelling, food safety issues etc. In practice it is almost exclusively food complaints we are asked for assistance with. Of the food complaints received they almost exclusively fall into two types; a)Foreign Body, in view of the degree of filtration and limited opportunity for contact with the product before bottling it is highly unlikely that such matter is introduced within the factory.

27. Originating Authority Liaison b)The other type of complaint we receive is algal growth. This type of complaint can be caused by incorrect storage. For algae to grow the product must be exposed to direct sunlight and warmth. It is not a production issue.

28. Originating Authority Liaison Algal complaints may be referred in unopened containers and it is assumed that this is a production issue. A complaint received was similar however when the EHO questioned the complainant further it emerged that the bottles had been stored in a warm caravan for a period in the middle of summer. In general there are a low number of complaints received regarding mineral water produced by Campsie Spring. Taking into account the fact that in an average year 152 -156 million litres of mineral water is sold by the company; this represents a very good complaint record.

29. Food Incidents My colleague working at another authority was assigned responsibility for a natural mineral water plant. He scheduled a full spectrum chemical analysis of the source. The sampling protocol was followed. Shortly after submitting the various bottles for analysis he received a phone call from the analyst to say that high levels of hydrocarbons were identified in the sample.

30. Food Incidents Contact was made with the company and they were asked as a precautionary measure to cease production. An investigation into the source of the contamination was undertaken. The owner asked what the outcome would be of the source was contaminated with hydrocarbons? The answer was that the source could no longer be exploited and that the product would require to be recalled.

31. Food Incidents It was ascertained that the catchment area was not protected. The business owned part of it but the bulk was owned by the forestry commission who worked the land with various equipment and there was potential for leaks of hydrocarbons into the catchment area. The next sample was clear. Control of catchment area is a crucial CCP.

32. Guidance –‘The Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) No. 2 Regulations 2007 – Guidance to the Legislation –Food Industry Guide to Good Hygiene Practice: Bottled Water –The Food Law Practice Guidance (Scotland) pages 73-76 provide specific guidance on enforcement of the Regulations. –Claire Moni and her team at the FSA are a good source of information with regards to the regulations. –The London HQ also can provide useful advice on technical issues.

33. Food and Veterinary Office Mission In November 2007 our authority was contacted by the Food Standards Agency to advise that an FVO mission was to take place in December 2007 looking at the U.K’s official controls for Natural Mineral Water. The preferred site for the mission was Campsie Spring. The FVO inspectors also intended to carry out a mission on the U.K’s official control labs and Glasgow Scientific Services were selected for that purpose.

34. Food and Veterinary Office Mission In the lead up to the mission the FSA provided support to prepare for the mission and a site meeting was arranged to meet with key personnel prior to the European inspectors’ visit. It was explained it was an inspection/audit of official controls NOT the business.

35. Food and Veterinary Office Mission The preparation for the mission raised questions regarding the regulations which had never arisen before What does sampling at source mean? Do official control samples have to be taken on a ‘formal sampling’ basis i.e. split into three parts? As stated in the Regulations? It was also clear that the initial recognitions would be looked at.

36. Food and Veterinary Office Mission The Framework Agreement requires retention of 6 years of records. The mission would be looking at documents from up to 22 years ago!! Inevitably some documents from the files were not available. Although we were reasonably confident that we had the required documents, we wouldn’t know until the day.

37. Food and Veterinary Office Mission We also looked at other mission visits to Natural Mineral Water plants on the continent to get a feel for what was likely to be examined. The FSA advised us that based on previous missions the inspectors would be interested in the businesses’ files. They would also want electronic copies of our Service Plan, enforcement policy and other key procedures. We should also take sample bottles as they might wish us to take samples. We were also advised that the inspectors would want to tour the plant and would ask questions of ourselves and key personnel on site.

38. Food and Veterinary Office Mission We decided that I would be present on the day as the inspector for the plant and our Principal Officer would also be present. On the morning of the visit we ran over all the documentation and prepared to go to the factory. We agreed in the unlikely event of an inspection being required I would take the lead. We felt we were as prepared for the visit as we could be.

39. Food and Veterinary Office Mission At the site an opening meeting took place Panic! – No mains water supply to the plant! The FVO inspectors were advised that production would normally stop There was about 1½ hours supply of hot water in the system and the FVO inspectors indicated that they would still like to see the factory.

40. Food and Veterinary Office Mission During the opening meeting the FVO officers decided that they wanted to witness an inspection… It’s a strange situation to carry this out with such a large audience!! It went well. A review of documentation was carried out, including recognition, sampling and inspection processes.

41. Food and Veterinary Office Mission The FVO officers were particularly interested in our inspection form. One of the source files was examined. One of the officers was not confident that it had been recognised properly… until my colleague produced a yellowing lab report from the time of the initial recognition which ticked all the boxes on his checklist!

42. Food and Veterinary Office Mission The report was finally published and the outcome was very good. No observations were made regarding our Authority. Only a couple of minor observations were made and today's training is one of the follow up actions. It was a very interesting experience. We are very grateful to the staff at Campsie Spring and the FSA who put a lot of effort into supporting us which ensured a positive outcome from the mission.