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	England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Newby Foods Ltd, R (on the application of) v Food Standards Agency [2013] EWHC 1966 (Admin) (16 July 2013) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2013/1966.html Cite as: [2013] EWHC 1966 (Admin)

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IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

		Royal Courts of Justice Strand, London, WC2A 2LL
		16th July 2013

Mr. Justice Edwards-Stuart:

Introduction

1. Much of the meat that is on sale in today's shops in this country - and probably in other Member States of the European Union also - is the product of butchery by a machine, not by hand. According to the evidence in this case machines are not very efficient butchers, often leaving some 50% (and sometimes much more) of the meat on the bone. Unless this remaining meat is removed in some other way it will not be used as meat. It is, unfortunately, not cost effective in the mass market for this to be done by hand in the traditional way.
2. In the 1970s machines were developed that would crunch the bones and the residual meat against a perforated plate under high pressure, with the result that the lean meat, fat and bone marrow would be extruded in a form of slurry with a viscosity not dissimilar to that of a purée. This is known as mechanically separated meat ("MSM"). The consumer would not describe it as fresh meat.
3. However, within a couple of decades improved machines had been developed which could remove the residual meat from the bone without crushing the bones or liquefying the meat. The claimant has developed such a machine. By means of a vibrating piston, operating at a much lower pressure than the early crushing machines, the meaty bones are forced into contact with one another in such a way that most of the meat is removed from the bones by shearing forces. This meat, without any bone marrow, leaves the chamber via a perforated plate with 10 mm diameter apertures.
4. It is the claimant's case that the product that emerges is clearly recognisable as meat. It can be teased apart to reveal whole pieces of meat up to about 100 mm or more in length. The claimant submits that no-one would describe it as anything else.
5. The second stage in the claimant's process is to pass this meat through another machine that is effectively a mincer with 3 mm apertures. The extruded product looks like ordinary mincemeat. This product is known in the UK meat trade as "desinewed meat" (or DSM) because, as with most meat mincing operations, a substantial amount of sinew and gristle is caught and left on the inside of the machine.
6. Desinewed meat is regarded by many, including the Defendant, the Food Standards Agency ("FSA"), as being quite different from MSM produced by the high-pressure process described in paragraph 2 above.

Regulation (EC) No 853/2004

7. Regulation (EC) No 853/2004 of 29 April 2004 lays down "specific hygiene rules for food of animal origin". Annex I to the Regulation contains definitions^[1]. By paragraph 1.14:

"'Mechanically separated meat' or 'MSM' means the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcasses, using mechanical means resulting in the loss or modification of the muscle fibre structure."

By paragraph 1.15:

"'Meat preparations' means fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, and seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat."

8. The principal issue in this case is whether the product of the claimant's two stage process is MSM within the meaning of paragraph 1.14 or is fresh meat that satisfies the last part of the definition of meat preparations in paragraph 1.15.

The positions of the parties

9. The view taken by the EU Commission, as stated in written evidence from the Director-General of the Health and Consumers Directorate-General to the House of Commons Environment, Food and Rural Affairs Committee, is "that any loss or modification of the muscle fibre structure" results in a product that must be considered to be MSM^[2]. It was stated also in the same document that "MSM is very sensitive to bacterial growth because of the raw material and the production process involved".^[3]
10. The claimant's position, which until early 2012 was also the position taken by the FSA, is that it is only if there is significant "loss or modification of the muscle fibre structure", that the product is to be treated as MSM.
11. In support of this position, the claimant submits that a change is significant only if it is sufficient "to eliminate the characteristics of fresh meat" and thus takes the product out of the definition of "meat preparations" in paragraph 1.15.
12. The claimant submits also that to treat desinewed meat as MSM results in a substantial waste of meat that is acceptable for human consumption as fresh meat.
13. The evidence before the court shows that loss or modification of the muscle fibre structure of meat can be the result of many processes: for example, freezing and thawing, chopping and mincing. But each of the processes of freezing/thawing, chopping and mincing of fresh meat does not usually eliminate the characteristics of that meat: I do not imagine that anyone would suggest that a steak tartare is not fresh meat, but on the evidence in this case the process of chopping the beef would cause some measurable loss or modification of the muscle fibre structure. The meat used in steak tartare is not classified as MSM because it does not fall within the opening words of paragraph 1.14 of Annex I to the Regulation, not because there has been no loss or modification of the muscle fibre structure.
14. Thus the effect of the Commission's interpretation of paragraph 1.14 of Annex I to the Regulation is that any mechanical separation of meat from the bone after initial deboning, even if carried out without any damage to the bones themselves or extraction of bone marrow, will produce a product that has to be classified as MSM. That greatly reduces its commercial value.
15. The Commission would doubtless say that the merit of its approach is that it is clear: there can be no room for misunderstanding. By contrast, the approach contended for by the claimant, formerly supported by the FSA, means that whether or not the product of the mechanical separation is to be classified as MSM has to be the result of an individual assessment of the results of the particular process employed.
16. By way of background, it seems that in early 2012 the claimant and the FSA were not alone in their concern about the Commission's approach to the classification of MSM. At a meeting of the Commission Working Group on Implementing Measures of the Hygiene Regulations held on 9 March 2012, the Commission sought the views of Member States on MSM. A summary of the meeting indicates that whilst several Member States did not provide an opinion and said that they would respond in writing, a significant majority of those who spoke at the meeting were in favour of considering low pressure MSM as falling within the definition of "meat preparations" (in line with UK views). It was noted also that in many cases this was a change in their position.

The impact on this case

17. It is clear that the primary issue raised by the claimant in these proceedings is whether or not the de-sinewed meat that it produces as a result of its two stage process is properly classified as MSM within the meaning of paragraph 1.14 of Annex I to the Regulation.
18. If the Claimant's product were, as a matter of EU law, to be classified as MSM under paragraph 1.14 of Annex I of Regulation (EC) No. 853/2004 rather than as a "meat preparation" pursuant to paragraph 1.15 of that Annex, this would mean that:

i) the Claimant cannot use ruminant bones in the production of its product (see Annex V to Regulation (EC) No. 999/2001 as amended by Regulation (EC) No. 722/2007);

ii) the Claimant has to comply with the raw material and hygiene requirements which apply to MSM, rather than those which apply to meat preparations (see chapters II and III, section V, of Annex III to Regulation (EC) No 853/2004); and

iii) the Claimant's product is excluded from the definition of "meat" for labelling purposes (see Annex I to Directive 2000/13/EC as amended by Directive 2001/101/EC).

19. But that is not the only issue. The claimant also challenges the FSA's decision to implement the Commission's interpretation of the Regulation on a number of different grounds. For the purposes of this judgment, it is not necessary to go into the details of those claims. It is sufficient for me to say that some of them, at least, can succeed only if the claimant's interpretation of paragraph 1.14 is correct.

The facts in outline

20. In September 2003 the FSA issued Guidance Notes on the Labelling and Composition of Meat Products. In the Guidance Notes there was a section headed "What about mechanically recovered meat (MRM)?". This section contained the following paragraphs:

"Products obtained by mechanical deboning, which remove definitive pieces of meat from meaty bones or carcass, which may or may not have had the primal muscles previously removed, such that the muscle fibre structure of the meat is substantially intact are not considered to be MRM or MSM. This meat may then be desinewed and have the appearance of finely minced meat.

These products may still be considered meat, and may be counted towards the QUID declaration."

(QUID stands for Quantitative Ingredient Declarations.)

21. From about April 2006 the claimant was approved by the FSA to produce desinewed lamb meat as a "meat preparation". Two years later similar approval was given in respect of beef.
22. In December 2006 Regulation (EC) No 1923/2006 brought into force certain amendments to Regulation (EC) No 999/2001, which laid down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. One of these included an additional recital, (11b), to the former regulation, which was in these terms:

"Mechanically separated meat is obtained by removing meat from bones in such a way that the muscle fibre structure is destroyed or modified. It can contain parts of the bones and the periosteum (bone skin). Thus, mechanically separated meat is not comparable with regular meat. Consequently its use for human consumption should be reviewed."

23. I understand it to be the claimant's case that the desinewed meat produced by its process would very rarely, if ever, contain parts of bones or bone skin or bone marrow, although the presence of the occasional small shards of bone cannot be excluded.
24. In September 2010 the FSA issued further guidance in a document entitled "The production of meat preparations obtained by desinewing meat". The document stated that its purpose was to explain what desinewed meat is, where it fitted into the food hygiene legislation, the requirements for its production and "how it differed from mechanically separated meat (MSM)". The document contained the following passages:

"Desinewed meat

1. Desinewed meat is meat from which the sinews and tendons have been removed. It may be obtained from a number of sources including meat trim and the removal of residual meat from bones.

2. It is produced by passing trim or meaty bones through a low pressure machine where the material obtained appears to retain its muscle fibre structure. Some machines remove and desinew the meat as part of a continuous process; others do it in a two stage operation. The resulting product is variously known as Baader meat, 3 mm meat or desinewed meat; for the purposes of this document it is called desinewed meat. Whether a 'one stage' or a 'two stage' method is used it is the end result of both stages that should be considered to be the desinewed meat. Such material would appear to fall within the definition of a meat preparation (paragraph 1.15, Annex I of Regulation (EC) No. 853/2004), which includes 'fresh meat that has been reduced to fragments … or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat and thus to eliminate the characteristics of fresh meat'. As the muscle fibre structure is maintained, the material falls outside the definition of MSM in Regulation (EC) No. 853/2004, (ie. where the mechanical process results in the loss or modification of the muscle fibre structure). It cannot be considered to be minced meat because it is produced under pressure and not by cutting.

3. …

Mechanically separated meat (MSM)

4. The production of MSM is covered in section V, Annex III of Regulation (EC) No. 853/2004. This Regulation defines MSM as: 'the product obtained by removing meat from flesh-bearing bones after boning or from poultry carcasses, using mechanical means resulting in the loss or modification of the muscle fibre structure' (paragraph 1.14, Annex I of Regulation (EC) No. 853/2004, refers). A product meeting the description of MSM should comply with the specific legislative requirements for MSM in Regulation (EC) No. 853/2004. MSM is different to, and should not be confused with, meat preparations or desinewed meat.

5. The production of MSM will generally be from pig and poultry bones; MSM from specified risk material (SRM), and the bones, or bone-in cuts, of cattle, sheep and goats is, in most cases, prohibited under the Community TSE Regulation (Article 9(2) and point 5, Annex V of Regulation (EC) No. 999/2001). (See also paragraphs 10 and 18, below).

6. If the pressure used to remove the meat from the bone (paragraph 2 refers) is too great the resulting product may be MSM. Microscopy analysis can be used to assess whether there has been a loss or modification of the internal muscle fibre structure to determine whether the product meets the definition of MSM. Once a product has been classified as MSM it cannot be reclassified as a meat preparation or as desinewed meat.

Defining Muscle fibre structure

7. Neither the definition of meat preparations nor that of MSM in the food hygiene regulations provides a clear indication of what is meant by 'loss or modification of the muscle fibre structure' or the level of modification or loss necessary before a product ceases to be 'fresh meat' and becomes MSM. Recent enquiries to the European Commission indicate that any modification of the muscle fibre structure of the 'meat' during the removal process would cause the product to be classified as MSM. (See the Note towards the end of this document.)

8. It is worth noting that there is, generally, no muscle fibre structure present in samples of pork, chicken and turkey MSM examined under a microscope. However, even mincing processes and passing through a 3mm plate can result in some modification of muscle fibre structure. Microscopic analysis therefore allows only a subjective assessment of the appropriate categorisation of a product.

9 …

Identifying desinewed meat and MSM

10. It is the food business operator's responsibility to be able to demonstrate, including to the competent authority, that their product (at the end of the process, whether this is a one stage process or a two stage process) meets the criteria for desinewed meat and in particular that the muscle fibre structure of the product has not been lost or modified. Microscopic analysis can be used to assess the destruction of muscle fibre structure and hence assist in the decision as to whether a product falls within the definition of a 'meat preparation' and can be considered to be desinewed meat, or whether it is MSM. If the food business operator is unable to demonstrate that the product is desinewed meat then, in the case of product from cattle, sheep or goats, it could be illegal under Community TSE legislation. (See also paragraph 5 and 18).

…

20. As the law currently stands, production of desinewed meat on the bones of cattle, sheep and goats is legal, provided no SRM is included in the production process. The production of MSM from the same bones is illegal.

(Original emphasis)

25. On 2 December 2010, the European Commission issued a communication to the European Parliament and the Council "On the future necessity and use of mechanically separated meat in the European Union, including the information policy towards consumers". In its Introduction, the English translation of the document said this:

"Mechanically separated meat (MSM) is a product, obtained by removing remaining meat from bones or poultry carcasses using mechanical means, where the normal structure of the muscle fibre is mostly lost or modified in such a way that it is not comparable with regular meat."

(My emphasis)

This document went on to say (on page 4):

"However, potential public health concerns linked to the specific production method, including a potential BSE risk, have been identified in the past. The use of ruminant bones as raw material for the production of MSM is banned in the EU since 2001."

26. The document discussed the different types of production methods, in relation to which it said this:

"Visually, high-pressure MSM results in a product with a characteristic and particularly pasty texture resulting from the loss or modification of the muscle fibre structure. Other technologies (low pressure MSM), may result in a product that cannot or hardly be differentiated visually from minced meat.*

Microscopically, an evaluation of 'the loss or modification of the muscle fibre structure' is possible using microscopic sections of meat. A large variation of the modification of the internal structure of the product can be observed depending on the different production parameters used."

* A footnote noted that minced meat was defined as 'boned meat that has been minced into fragments and contains less than 1% salt'."

27. The document pointed out that different Member States had adopted different approaches to low and high pressure MSM. Some states had indicated that low pressure MSM was used for meat preparations (e.g. meat balls). Others indicated that only low pressure MSM was used for the production of meat products, while high-pressure MSM was only used in the production of pet food.
28. In March 2012 an audit team of the European Commission's Food and Veterinary Office (FVO) visited the claimant's premises. The Executive Summary of the audit team's report included the following:

"… the official controls implemented by the United Kingdom Competent Authorities do not guarantee that the EU requirements applicable to the production of mechanically separated meat are respected.

The creation of a new product category, non-existent in current EU legislation, called 'desinewed meat', with the backing of the United Kingdom Competent Authorities has led to major non-conformities such as the use of ruminants' bones for the production of mechanically separated meat, the production of mechanically separated meat without respecting all EU requirements and the placing on the market of products incorporating mechanically separated meat without identifying it on the label."

29. The authors of the report referred to a letter dated 7 September 2010 from the FSA which told Food Business Operators in the UK that products obtained from flesh-bearing bones after boning or from poultry carcasses with the aid of mechanical means may be categorised as either:

i) MSM (as defined above); or

ii) desinewed meat (in the form of a "meat preparation", as defined in Annex I, point 1.15 of Regulation (EC) No. 853/2004)

30. The report went on to say this:

"In this document [that is the letter of 7 September 2010] 'desinewed meat' is described as:

- Fresh meat from which the sinews and tendons have been separated by mechanical means at low pressure,

- Produced from fresh meat or from the removal of residual meat from bones (including ruminants' bones),

- Produced by passing meat trim or meaty bones through a low pressure machine in a one or two stage process,

- Meat which does not satisfy the third element of the definition of MSM as muscle fibre structure is not lost or modified to any significant extent.

The accompanying document to this letter indicates that in order to make the distinction between MSM and desinewed meat, the FBOs shall provide the CA with microscopy analyses results demonstrating that the muscle fibre structure of the product at the end of the process has not been lost or modified. In this case, the desinewed meat produced would fall under the definition of meat preparations. As a consequence, the establishment producing the desinewed meat will be approved for the production of meat preparation and not for MSM production. According to the procedure described in the document, the key determining factor as to whether a product falls within the definition of MSM or desinewed meat is the laboratory microscopy analysis result."

31. The authors of the report then stated that:

"… the audit team noted in all establishments visited where desinewed meat was produced that these microscopy analyses results (where available) never indicated that there was no loss or no modification of the muscle fibre structure. On the contrary, a modification up to a certain extent was always reported."

(My emphasis)

32. The conclusion of the report was that the product called "desinewed meat" fell within the definition of MSM:

"… as all three criteria of the EU legislation (meat removed from flesh-bearing bones after boning; use of mechanical means, and the loss or modification of the muscle fibre structure) are met (see Annex I, point 1.14 of Regulation (EC) No 853/2004)."

33. This report clearly highlighted the difference in interpretation of paragraphs 1.14 and 1.15 of Annex I to the Regulation by the FSA in the UK and the FVO on behalf of the Commission. The FVO auditors rejected the approach adopted by the UK authorities that in order for the product to be classified as MSM, as opposed to a meat preparation, the muscle fibre structure had to be lost or modified to a significant extent. The FVO's view appears to have been that any modification of muscle fibre structure visible on microscopy analysis meant that the product had to be classified as MSM.
34. This approach is consistent with the conduct of the auditors when carrying out the audit as reported by the claimant. Mr. Doug Manning, the claimant's Operations Director, said that the FVO team told the claimant's staff that they were only interested in looking at the microscopy analysis reports produced by Leatherhead Food Research ("Leatherhead"). He said that they took no interest in the meat that was produced after stage one of the production process and were not even prepared to look at it (although it seems that they did take photographs). The claimant left some of it on a tray in the boardroom for some three hours during the auditors' visit to demonstrate that it did not discolour after that time, even at ambient temperatures in the boardroom. Mr. Manning said that if this had been MSM produced under high pressure it would have discoloured noticeably within that time.
35. On 14 March 2012 the FVO auditors held their closing meeting with the FSA. An internal FSA email set out a brief record of the meeting in the following terms:

"In summary, there was an underlying position from the FVO auditors that they do not recognise desinewed meat (DSM) as a legally acceptable term for product derived from meat from flesh bearing bones and obtained with the aid of mechanical means, irrespective of the degree to which the muscle fibre structure is modified or lost. This contrasts with the UK position where, having met the first two criteria, a DSM product can be obtained depending on the degree to which the muscle fibre structure is modified. Consequently, the FVO consider all of the DSM they saw during the course of the audit as MSM and many, but not all, of their comments arose as a result of this stance."

36. This confirms that it was the FVO's view that any modification of muscle fibre structure visible on microscopy analysis meant that the product had to be classified as MSM.
37. On 28 March 2012, Paola Testori Coggi, Director-General of the Health and Consumers Directorate-General, wrote to the UK Permanent Ambassador to the EU in the following terms:

"… the findings and the preliminary assessment of the audit indicate a number of serious failures with regard to the interpretation and implementation of the above-mentioned rules by the UK authorities, which result in a violation of EU health requirements as laid down in Regulation (EC) No 853/2004 on hygiene rules for food of animal origin and in Regulation (EC) No 999/2001 on rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, and poses a risk for public health in the UK and in other member states.

… The production and placing on the market of a product category ('desinewed' meat) that the UK authorities erroneously consider not to fall under the definition of mechanically separated meat (MSM) as referred to in Regulation (EC) No 853/2004. The FSA UK guidance paper on this subject indicates that 'desinewed' meat would rather qualify as 'meat preparation' as the muscle fibre structure is not modified by the mechanical separation process but the audit team found consistent evidence that this product always shows modification of this structure;

…

As my colleagues indicated to UK officials during the above-mentioned audit, the interpretation given by the UK authorities to the provisions applicable to MSM is not correct. Such interpretation and the manufacturing practices which are based on it, have potentially very serious adverse consequences for public health and must be discontinued as a matter of urgency."

38. The letter did not explain precisely what the public health risk was or how it was said to arise.
39. On 30 March 2012, representatives of the FSA and the Commission met in Brussels. The Commission's team was led by Dr. Van Goethem. According to the FSA's note of the meeting, the FSA set out its view that there was no evidence that desinewed meat posed a risk to consumers. In return for imposing a moratorium, the FSA asked the Commission to undertake to provide a risk assessment of desinewed meat. However, the Commission was not prepared to negotiate. Dr. Van Goethem said that the Commission wished to see an immediate ban on the use of ruminant bones and the reclassification of desinewed meat as MSM or they would introduce safeguard measures, which would have very severe consequences for the UK meat industry.
40. On 4 April 2012 the FSA issued an announcement entitled "Moratorium on desinewed meat" in the following terms:

"The UK has been required to re-classify the process by which a very small part of its meat processing industry removes meat from animal bones.

The European Commission has asked that a moratorium is put in place on the production of 'desinewed meat' (DSM) from cows and sheep^[4]. Desinewed meat is produced using a low pressure technique to remove meat from animal bones. The product closely resembles minced meat, is currently a meat preparation and is regarded as meat.

DSM has been produced in the UK since the mid-1990s. UK producers have told us that DSM is also exported by other EU countries such as Germany, the Netherlands and Spain.

The Food Standards Agency (FSA) is clear that there is no evidence of any risk to human health from eating meat produced from the low-pressure DSM technique. There is no greater risk from eating this sort of produce than any other piece of meat or meat product. The European Commission has informed us today they do not consider this to be an identified public health concern.

However, the European Commission has decided that DSM does not comply with European Union single market legislation and has therefore required the UK to impose a moratorium on producing DSM from the bones of cows and sheep by the end of April. If the UK were to not comply with the Commission's ruling it would risk a ban on the export of UK meat products, which would have a devastating impact on the UK food industry.

DSM may still be produced from poultry and pig bones but from the end of May it must be classed and specifically labelled as 'Mechanically Separated Meat' (MSM), and can no longer count towards the meat content of a product."

41. It is a remarkable feature of this announcement that, in spite of the fact that the Director-General's letter referred to serious adverse consequences for public health, within a few days of that letter the Commission was reported as having said that there was no public health concern. In fact, so far as I am aware, the Commission has never in writing withdrawn the assertion about the existence of the adverse public health risk. Equally, so far as I am aware, it has provided no evidence to support it.
42. The following month the FSA produced a document giving guidance on the moratorium, which concluded its explanation of the background to the moratorium in these terms:

"There is no evidence of any increased food safety risks associated with non-ruminant DSM obtained by mechanical separation or the process by which it is produced. There has, however, been a difference in interpretation of the definition of 'mechanically separated meat' (MSM) in EU law between some European member states, including the UK, and the European Commission."

43. In a similar vein, in the action plan prepared by the United Kingdom competent authorities in response to the report of the FVO auditors, under the heading "Action Proposed by the Competent Authority" the FSA said this:

"The Food Standards Agency disagrees with the phrase in the recommendation 'avoid risks to public health'. It was agreed at a meeting between Food Standards Agency Chief Executive Tim Smith and Paola Testori Coggi, Director-General DG SANCO on 24 May 2012 that the reference to 'risks to public health' should be removed from the report.

The Food Standards Agency also disagrees that material produced under low pressure falls within the definition of MSM and instead considers it to fall within the definition of 'meat preparations'.

However, in order to comply with the European Commission's interpretation of EU legislation, and further to discussion with the Commission, the UK introduced a moratorium on the production of desinewed meat from ruminant bones on 28 April 2012 …"

(Original emphasis)

44. On 15 May 2012 Mr. Tim Smith, the Chief Executive of the FSA, gave evidence to the House of Commons Environment, Food and Rural Affairs Committee. He said this:

"It is easy to look back with hindsight. … What they were intending to do, in my opinion, having read their brief, was effectively to look at the processes - the low pressure methods for separating meat from meaty bones. We are talking here about bones that are sometimes 80% meat, which normally, 10, 20 years or even longer ago, would have been boned out by people with knives. There is now equipment that does that.

What they were intending to do was to determine whether the muscle fibres were being damaged sufficiently to cause that to be mechanically separated meat, rather than meat that would have been boned out in the normal way. Our view was that Newby Foods and others, which have done an excellent job of innovating in this area, would be able to demonstrate, using the Leatherhead method, with histology and microscopy, that the muscles are not being damaged. We were confident that the industry was in a strong position to demonstrate that this meat was meat and not mechanically separated meat."

A little later, in answer to a question from the Chair, Amber Rudd MP, "Do you remain satisfied, Mr. Smith, that desinewed meat is no public health risk?", Mr. Smith said:

"I do, yes. The way that the industry has approached this innovative way of effectively harvesting meat from meaty bones is entirely sensible. It is only the same as having lots of people with lots of knives at the end of the line. It is no different from that process."

45. In its written submissions to the Committee, the FSA said that in 2011 the consumer group "Which?" conducted research into consumer attitudes to meat products, including DSM. It said that this research found that consumers viewed DSM as being distinct from MSM and thought that it should count towards the meat content of the final product, whilst being identified separately as an ingredient on the label.
46. Evidence from the Commission given to the Committee in May 2013 makes it abundantly clear that the production of desinewed meat or MSM from pigs and poultry does not raise any risk to public health. So far as pigs and poultry are concerned, it is an issue about labelling. The Commission believes that it must be labelled as MSM, so that the meat content of the product attributable to the MSM must be shown as 0%.
47. However, it seems that the Commission holds the firm view that desinewed meat produced from flesh bearing ruminant bones does present a public health risk. It appears that the reason for this is that there is a risk that bones will be damaged in any mechanical process for the removal of meat from bones and that it is the bones themselves that present the TSE risk.
48. It is not necessary for me to examine this view that the use of flesh bearing ruminant bones in the claimant's process presents a public health risk. For the purposes of this judgment I am prepared to assume that it is a legitimate concern. But in my view that simply raises the issue as to whether ruminant bones should be used in the claimant's process, not whether the product of that process is properly classified as MSM.
49. Many of the arguments deployed by the Commission appear to overlook this distinction. The Commission says, rightly, that it is not lawful to produce MSM using the flesh bearing bones of ruminants. It then says that what the claimant was doing prior to the moratorium was unlawful because ruminant bones were being used. But this argument relies on the assertion that what the claimant is producing is properly classified as MSM. The argument is circular.

The evidence contained in the witness statements

50. In accordance with the normal practice in the Administrative Court, no evidence was called at the hearing but both sides submitted witness statements. In judicial review proceedings the contents of such witness statements are often not contentious.
51. The claimant served a written statement by Kathy Groves, a scientist working in food microscopy employed by Leatherhead. Leatherhead is an independent research organisation that for nearly 100 years has provided services to the food industry. She said that the easiest way to check muscle fibre structure is by looking at it under a microscope. However, in relation to the product that was produced by the first stage of the claimant's process she said:

"Trim harvested from the first stage of Newby's process looked visually to be definitive pieces of meat that didn't need looking at under a microscope as the meat had not been fragmented unduly at the first stage."

52. She explained that the initial research that Leatherhead was commissioned to carry out concerned only chicken, turkey and pork. She said that the samples of these meats that were examined by Leatherhead showed large differences in the state of the muscle structure between desinewed meat and MSM: MSM had very little muscle structure whereas the desinewed meat had a large proportion of muscle structure. She said that the hand de-boned and minced and the desinewed meat produced somewhat variable results in terms of modification to the muscle fibre structure, in that some areas were nearly intact and other areas showed some damage to the muscle and dispersion of the protein. But she said that overall the results were perfectly clear in that MSM showed very little recognisable muscle fibre structure at all, whereas that was not the case for the desinewed meat. She said that the latter was more like hand de-boned minced meat. She said that blind testers were able to tell the difference between desinewed meat and hand deboned meat, but not invariably.
53. In relation to chicken, turkey and pork she expressed her conclusions in these terms:

"Based on these results any sample of meat with a sufficient level of intact structure relative to the control sample used during the research (ie. the meat minced from hand de-boned meat) could be considered as a meat preparation. MSM could not fall within that definition (the modification of the muscle fibre was too great) but desinewed meat could be categorised in the same way taking into account the muscle fibre structure of the meat."

54. For the purpose of comparing samples of beef and lamb desinewed meat and MSM, special samples of MSM (which could not be lawfully produced for consumption) were obtained for the purposes of the project. In a report dated 12 September 2011, Ms. Groves described the results of the light microscopy examination of the samples of beef and lamb in the following terms:

"In this project, the difference between the samples was not as clear-cut, as the samples produced under high pressure did not show the large destruction of muscle fibre structure that was evident in chicken, pork and turkey. Nevertheless the results in general indicated a high level of intact muscle structure in DSM [desinewed meat] in comparison to the lower level seen in MSM. Mincing of hand deboned meat showed similar or slightly lower levels of disruption in muscle structure than for DSM."

55. Her opinion, which reflected the view taken by Leatherhead, was that the product produced by the claimant was almost as good as minced meat in terms of the microscopic structure of the muscle fibre. To treat it as MSM was, in her view, a waste.
56. The claimant also served a witness statement from Dr. Mark Woolfe, a consultant with 25 years experience working for the UK Government, first at the Ministry of Agriculture, Fisheries and Food, from 1984-2000, and subsequently at the Food Standards Agency from 2000-2009.
57. He explained that MSM was significantly different in composition and structure to ordinary meat. By contrast, the process developed by the claimant removed the meat from the bones and poultry carcasses in a way that did not materially alter its structure and composition, so that it was quite different to MSM. This product was referred to as desinewed meat and could be sold as a meat ingredient and count towards the meat content of the product in which it was incorporated.
58. He said that the old high pressure processes involved compressing the bones so that all the water and bone marrow was squeezed out of them. The resultant purée was then passed through a 1 mm filter to prevent bone particles and connective tissue from passing through. His conclusion was that the results of the research carried out by Leatherhead were clear: the desinewed meat produced by the claimant's process had a similar structure and a similar presence of muscle fibre to minced meat, whereas MSM had totally lost any structure and was simply a continuum of protein and fat.

My provisional conclusions

59. All parties are agreed that the product of the mechanical separation of meat from flesh bearing bones carried out under high pressure is properly classified as MSM. It has the appearance and texture of a purée and is nothing like fresh meat.
60. I am satisfied that the "desinewed meat" produced by the claimant's two-stage process is quite different in appearance and texture from the product produced by mechanical separation carried out at high pressure. I am equally satisfied that the muscle fibre structure of that desinewed meat undergoes some modification during the process. Accordingly, if it is sufficient for it to be classified as MSM that there has been any modification of the muscle fibre structure, then it is MSM.
61. The wording of paragraph 1.15 of Annex I to the Regulation ("… and thus to …") indicates that there has to be a causal link between the loss or modification of the muscle fibre structure and the elimination of the characteristics of fresh meat. Further, I do not consider that this wording can be construed to mean that any diminution, however minor, of those characteristics amounts to elimination of those characteristics. It seems to me that there has to be at least a significant diminution in those characteristics before they can be said to have been eliminated. I consider that in this context the relevant characteristics of fresh meat are its organoleptic properties (taste, smell, texture and so on).
62. The claimant submits that a curious feature of the application of this regulation is that chicken breasts are commonly removed from the carcass by mechanical means and this inevitably causes some modification of the muscle fibre structure at the point where the meat is cut. This process would appear to fall within the definition in paragraph 1.14 of Annex I. Yet meat produced in this way is sold as fresh meat. The claimant does not criticise this: on the contrary, it cites it as an example of the absurd consequences that would follow if any damage to the muscle fibre structure were to lead to the meat product in question being classified as MSM. Alternatively, it demonstrates an inconsistency of the application of the Regulation. The claimant relies on the guidance on the moratorium that was issued by the FSA with effect from 26 May 2012 in relation to desinewed meat from non-ruminants' bones or poultry carcasses. This stated that:

"Meat removed by mechanical means from non ruminant bone-in cuts of meat that have not been subject to any previous boning is not considered to be MSM. Examples include wishbone meat, and recognised pork and poultry cuts."

63. Paragraph 1.14 of Annex I defines MSM as including the product obtained by removing meat from poultry carcasses using mechanical means if, according to the Commission, that results in any loss or modification of the muscle fibre structure. However, the Commission appears to tolerate the fact that meat is regularly removed from poultry carcasses by mechanical means but is not treated as MSM. The claimant submits that this amounts to manifestly unequal treatment in breach of the principle of equality: see Royal Scholten-Honig v Intervention Board for Agricultural Produce (Cases 103 and 145/77), at paragraphs 82-84.
64. I am satisfied from the evidence produced in this case that the product of the claimant's two-stage process has not resulted in the elimination of the characteristics of fresh meat. Nor do I think that there has been a sufficient diminution of those characteristics to prevent the product falling within the definition of "meat preparations" in paragraph 1.15 of Annex I to the Regulation.

Is this a question that should be referred to the Court of Justice of the European Union?

65. In CILFIT Srl v Ministero della Sanita [1982] ECR 3415 the Court provided guidance on the factors which should be taken into account when considering a reference to the Court. First, Community legislation is drafted in several languages and the different language versions are all equally authentic. An interpretation of a provision of Community law thus involves a comparison of the different language versions. Second, even where the different language versions are entirely in accord with one another, Community law uses terminology which is peculiar to it. The Court emphasised that legal concepts do not necessarily have the same meaning in Community law as in the law of the various Member States. Third, the Court stated that every provision of Community law must be placed in its context and interpreted in the light of the provisions of Community law as a whole, with regard being had to its objectives and to its state of evolution at the date on which the provision in question is to be applied.
66. In Customs and Excise v ApS Samex [1983] 1 All ER 1042, Mr. Justice Bingham (as he then was) summarised the position from the perspective of a judge sitting in a national court with his usual clarity in the following terms, at 1055:

"[The Court] has a panoramic view of the Community and its institutions, a detailed knowledge of the treaties and of much subordinate legislation made under them, and an intimate familiarity with the functioning of the Community market which no national judge denied the collective experience of the Court of Justice could hope to achieve. Where questions of administrative intention and practice arise the Court of Justice can receive submissions from the Community institutions, as also where relations between the Community and non-member states are in issue. Where the interests of member states are affected they can intervene to make their views known. That is a material consideration in this case since there is some slight evidence that the practice of different member states is divergent. Where comparison falls to be made between Community texts in different languages, all texts being equally authentic, the multinational Court of Justice is equipped to carry out the task in a way which no national judge, whatever his linguistic skills, could rival. The interpretation of Community instruments involves very often not the process familiar to common lawyers of the laboriously extracting the meaning from words used but the more creative process of supplying flesh to a spare and loosely constructed skeleton. The choice between alternative submissions may turn not on purely legal considerations, but on a broader view of what the orderly development of the Community requires. These are matters which the Court of Justice is very much better placed to assess and determine than a national court."

67. In the light of this guidance, I consider that in principle this is a paradigm case for a reference to the Court of Justice for three reasons. First, this is a piece of EU, not national, legislation. Second, the members of the Court will have the benefit of being able to consider the Regulation in several different translations. Third, the members of the Court are in a far better position than a judge sitting in a national court to reach a decision on what is in essence a question of principle which has to be decided in the light of the circumstances prevailing throughout the European Union.
68. It will be apparent from the summary of the issues that I have already given, that this is a case where the outcome depends substantially on the correct interpretation of the Regulation. For the reasons that I have just given, I consider that this is a case where the court should not give a final judgment on the issues between the claimant and the FSA in these proceedings until there has been an interpretation of the Regulation from the Court of Justice. However, there is an application by the claimant for interim relief which is the subject of a separate judgment.
69. I have therefore concluded that this is a case where the questions which arise as to the meaning of paragraphs 1.14 and 1.15 of Annex I of the Regulation should be referred to the Court of Justice of the European Union. With the assistance of the parties I have formulated the question in the terms set out below.

The questions to be referred

70. This court refers the following questions for a preliminary ruling by the Court of Justice of the European Union:

i) Do the words "loss or modification of the muscle fibre structure" in paragraph 1.14 of Annex I of Regulation (EC) No 858/2004 mean "any loss or modification of the muscle fibre structure" that is visible using standard techniques of microscopy? (The same words appear also in Article 3(n) of Regulation (EC) No. 999/2001, as amended by Regulations (EC) No. 1923/2006).

ii) Can a meat product be classified as a meat preparation within paragraph 1.15 of Annex I where there has been some loss or modification of its muscle fibre structure that is visible using standard techniques of microscopy?

iii) If the answer to to (i) is no and the answer to (ii) is yes, is the degree of loss or modification of the muscle fibre structure that is sufficient to require the meat product to be classified as MSM within paragraph 1.14 of Annex I the same as that required to eliminate the characteristics of fresh meat within paragraph 1.15?

iv) To what extent must the characteristics of fresh meat have been diminished before they can be said to have been eliminated within the meaning of paragraph 1.15?

v) If the answer to (i) is no, but the answer to (iii) is also no:

a) What degree of modification to the muscle fibre structure is required in order for the product in question to be classified as MSM?

b) What criteria should be used by national courts in determining whether or not the muscle fibre structure of the meat has been modified by that degree?

Note 1    This definition appears also in Article 3, paragraph 1(n) of Regulation (EC) No 999/2001 (as amended by Regulation (EC) No 1923/2006) which lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies.    [Back]

Note 2    Undated written evidence to the Committee (May/June 2012).    [Back]

Note 3    This sweeping generalisation - made in the light of the Commission’s interpretation of MSM - is not supported by the evidence in this case. Desinewed meat as produced by the claimant appears to be far less sensitive to bacterial growth than MSM produced by the high pressure process described in paragraph 2.    [Back]

Note 4    The announcement was subsequently revised to replace the words “cows and sheep” by “cattle, sheep and goats”.    [Back]