Newby Foods Ltd, R (on the application of) v Food Standards Agency (No. 2) [2013] EWHC 2132 (Admin)

Case No CO/6923/20122013] EWHC 2132 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN’S BENCH DIVISION
ADMINISTRATIVE COURT
Venue Royal Courts of Justice, Strand, London, WC2A 2LLDate 26 th July 2013
Before
MR. JUSTICE EDWARDS-STUART
Between
The Queen (on the application of Newby Foods Ltd)ApplicantFood Standards AgencyRespondent
Hugh Mercer Esq, QC & Andrew Legg Esq(instructed by Clarke Willmott LLP)) for ApplicantClive Lewis Esq, QC & Michael Lee Esq(instructed by Food Standards Agency) for RespondentHearing Hearing dates: 22 nd& 23 rd May 2013; 20 th June 2013
JudgmentMr. Justice Edwards-Stuart:I ntroduction
[1]This is the second judgment in this case. In the first judgment I referred the principal questions of interpretation of the relevant EU regulation to the Court of Justice of the European Union. This judgment concerns the Claimant’s application for interim relief pending the decision from the Court of Justice. However, to save the reader from reading the first judgment I shall reproduce the relevant parts of it in this judgment.[2]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.[3]In the 1970s machines were developed that would crunch the bones and the residual meat against a perforated plate, 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 puree. This is known as mechanically separated meat (“MSM”). The consumer would not describe it as fresh meat.[4]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 meat bearing 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.[5]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.[6]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.[7]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 3 above.

Regulation (EC) No 853/2004

[8]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 This definition appears also in Article 3, para 1(n) of Regulation (EC) No 999/2001 which lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. . 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.”[9]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

[10]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 anyloss or modification of the muscle fibre structure” results in a product that must be considered to be MSM Undated written evidence to the Committee (probably May 2012). . 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”. 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.[11]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”, the product is to be treated as MSM.[12]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. Thus the principal issue between the parties (or, more accurately, between the Claimant and the Commission) is the correct interpretation of paragraphs 1.14 and 1.15 of the Regulation.[13]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.[14]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.[15]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.[16]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.[17]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 facts

[18]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 QUID stands for Quantitative Ingredients Declarations. declaration.”

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

[19]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.[20]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.”
[21]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.[22]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: “Every effort has been made to ensure that the information in this document is as helpful as possible. However, it is ultimately the responsibility of individual businesses to ensure their compliance with the law. Food business operators with specific queries may wish to seek the advice of FSA’s Operations Group, in York or their local enforcement agency (usually the environmental health department of the local authority). The information in this document should not be taken as an authoritative statement of the law as only the courts have this power. 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. Whilst this desinewed meat is derived from fresh meat and still retains the characteristics of fresh meat it has, nevertheless, undergone a process (ie it has been removed from the bone and been desinewed, whether in one stage or two stages). However the process was insufficient to substantially alter the initial product and thereby turn it into a meat product. (The definition of a ‘meat product’ in paragraph 7.1, Annex I of Regulation (EC) 853/2004 and of the ‘processing’ in Article 2.1 (m) of Regulation (EC) 852/2004, refer.) 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. There are many machines on the market that can be set up to remove meat from the bone or remove sinew from trim to produce a variety of grades of product. It is therefore recommended that, before they start operations, food business operators agree with their authorised officer a standard operating practice for the production of desinewed meat. This will avoid later problems. The process should be covered in the food business operator’s HACCP plan for the premises. 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). 11. The Agency has funded the development of a simple microscopy method to assess the level of integrity of muscle fibre structure and the presence of other structural aspects in mechanically separated pork, chicken and turkey meat. The method involves sectioning and staining the sample, followed by examination of the structural parameters by comparing them with reference samples of pork, chicken and turkey MSM, desinewed meat, hand-deboned and minced meat. The presence or absence of key structural features and the extent of muscle fibre disruption is assessed, allowing a judgement to be made as to whether a product meets the definition of MSM or falls outside this definition. … 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. 21. However the Commission is expected to publish a report on MSM production in Member States in the autumn and this may lead to discussion on the current definition of MSM. We are advised that at present it is thought unlikely that this will result in changes in the definition of ruminant MSM for the purposes of the TSE Regulations, but food business operators contemplating significant investment related to the production of desinewed meat from cattle, sheep or goats, may wish to be aware that the possibility of a change in the rules remains.” (Original emphasis) Desinewed meat Mechanically separated meat (MSM) Defining Muscle fibre structure

Identifying desinewed meat and MSM

[23]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.”
It noted also, at page 5, that:
“Mechanically separated meat (also referred to as mechanically recovered meat) differs significantly from ‘meat’ as perceived by consumers.”
[24]The document went on to discuss 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 explained that minced meat was defined as “boned meat that has been minced into fragments and contains less than 1% salt”.[25]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.[26]In March 2012 an audit team of the European Commission’s Food and Veterinary Office (FVO) visited the Claimant’s premises. The Executive Summary included the following:
“The report concludes that 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.”
[27]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).[28]The report then went on to say this: “In this document ‘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 CAA with microscopy analyses results demonstrating that the muscle fibre structure of the product at the end of the process has not been lost on 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.”• 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.[29]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)[30]The conclusion of the report was that the product called “desinewed meat” fell within the definition of MSM:
“… as all three criteria of 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).”
[31]This report clearly highlighted the difference in interpretation of paragraphs 1.14 and 1.15 of Annex I to the Regulation between 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.[32]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.[33]On 14 March 2012 the FVO auditors held their closing meeting with the FSA. The 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.”
[34]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.[35]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 (‘de-sinewed’ 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 ‘de-sinewed’ 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.”
[36]The letter did not explain precisely what the public health risk was or how it was said to arise.[37]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.[38]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. The announcement was subsequently revised to replace the words "cows and sheep" by "cattle, sheep and goats". 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 not to 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.”
[39]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.[40]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.”
[41]In a similar vein, in an 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)[42]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. I think it is now clear that what they were intending to do, and what they will do in other member states - I am certain of that - is to look at the interface between what they regard as mechanically separated meat and what the industry and regulators in those different member states view as desinewed meat. 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.”
[43]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.”
[44]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.[45]Written evidence submitted to the Committee by Anne Milton MP, the Parliamentary Under Secretary of State for Public Health, included the minutes of a meeting of the Advisory Committee on Dangerous Pathogens, TSE Risk Assessment Subgroup, held on 25 May 2012. That committee recorded the views of the FSA that the consumption of the desinewed meat did not raise any public health concerns because, amongst other reasons, the process for producing desinewed meat did not damage bones and release bone marrow into the product.[46]However, it appears that this was not accepted by the Advisory Committee. In discussion, its members noted that the presence of bone marrow and/or dorsal root ganglia presented a potential TSE risk. They considered that it was clear from the FSA presentation that the bones were broken in the production process and that bovine vertebral column was used to produce desinewed meat, although not specified risk material bovine vertebral column. The Committee identified the key question as being how certain it could be that there is no bone marrow or dorsal root ganglia present in the desinewed meat. The members agreed that it was likely that neural tissue and bone marrow would be present in varying amounts in both desinewed meat and MSM produced from bovines if MSM production was permitted. Because of this they concluded that the TSE risk from both desinewed meat and MSM was likely to be similar. Nevertheless, the conclusion of the Committee was that the risk was low and was similar to the risk presented by the raw material used in the process. In other words, that it was not the process of producing desinewed meat or MSM that created the risk, but the possibility that TSE was present in the raw material.[47]The Committee concluded the introduction to its report with these words:
“The European Commission’s decision to request a moratorium at extremely short notice has had devastating consequences for British producers. It is extremely disappointing that the Commission was unable, or unwilling, to provide oral evidence to this Committee. The Commission’s failure to justify its actions and fulfil its duty to provide oral evidence to the National Parliament of a Member State demonstrates a worrying disregard for democratic accountability.”
[48]At paragraph 11 of the section headed “The government’s handling of events leading to the moratorium”, the Committee made this comment:
“The Commission’s decision to request a moratorium in the absence of any scientific evidence that de-sinewed meat represents a food safety risk was totally disproportionate and unacceptable. We are clear that the Food Standards Agency’s assessment that de-sinewed meat presents no risk to public health is correct, and we have no doubt that they were right to take a science and evidence based approach to assessing the risk with regard to food safety. However, we believe that their failure to anticipate that the Commission might not take the same approach is demonstrative of a lack of political awareness on the part of the FSA which must be addressed.”
[49]An audit by the FVO in the Netherlands which took place from 26 November to 5 December 2012 disclosed that the competent authority in the Netherlands took the view that the separation of meat from bones carried out at low pressure could be described as “meat” if: the bones were not crushed or damaged; there was no increased level of calcium or bone fragments; there was no loss or modification of muscle fibre structure. The response by the competent authority in the Netherlands to the FVO’s recommendations indicated that the meaning of the expression “loss or modification of muscle fibre structure” was “not quite clear” and that it was looking forward to clarification of this from EFSA.[50]In March 2013 the European Food Safety Authority produced a Scientific Opinion on the “Public health risks related to mechanically separated meat (MSM) derived from poultry and swine”. The authors noted that rapid and major recent technological developments in the area had resulted in situation where some technologies for low pressure recovery of meat were able to provide a final product with characteristics close or similar to those of minced meat. More specifically, at page 12 of the document, the authors said this:
“Over the years, gradual technological improvements and pre-selection of the different types of flesh bearing bones pressed at much lower pressure (up to 20 bar) produced a coarse texture higher quality meat that could no longer be distinguished from traditional minced meat (so called 3 mm or Baader meat) (CEN, 2010).”

In their recommendations, the authors said this (at page 54):

“Based on changes in processing and properties of derived MSM products, the classification and confirmatory testing of raw meat recovered after deboning should be also based on certain parameters of the final product, such as calcium content. New terminologies may be needed for low and high pressure MSM, because technological advances have resulted in low pressure products resembling minced meat. For example ‘low pressure MSM’ could be simply called ‘mechanically deboned meat (MDM)’, while ‘high-pressure MSM’ could be named ‘high calcium mechanically separated meat (HCaMSM)’.”
In their recommendations, the authors said this (at page 54):[51]On 21 May 2013 representatives from the EU Commission gave evidence to the House of Commons Environment, Food and Rule Affairs Committee which was investigating the use of horse meat in meat products. During the course of this evidence there was some discussion about MSM. Dr. Bernard Van Goethem, Director in the Commission, working for the Directorate-General Consumer and Health, but (as he explained) more specifically veterinary and international affairs, having explained that the terms desinewed meat and Baader meat did not exist in Community legislation, said this: The passages quoted are taken from the uncorrected transcript of the oral evidence, which is to be published as HC 120. At the time of preparing this judgment the corrected transcript was not available. “The BSE and TSE regulations prevent producing mechanically separated meat from ruminant bones: sheep, goats, or bovine. That is strictly forbidden, due to the risk linked with the BSE agent, which is in the bone. When you crush the bone, obviously you can widely spread the agent of Creutzfeldt-Jakob, which is in the bone. That is why the Parliament and the Council, very correctly, absolutely prohibit mechanically separated meat from ruminant bones. You can call it de-sinewed meat or Baader meat, or whatever, but as long as you crush the bones, you are really putting public health at risk. That is why we took such action one year ago. Q611 Chair: What you are saying is that is for ruminants, for beef, but for non-ruminants like pigs and lamb [sic], we can use mechanically separated meat.”[52]Some further questions from the Chair, Miss Anne McIntosh, were also answered by Mr. Koen Van Dyck, the Head of Unit in the directorate of Dr. Van Goethem, with particular responsibility for dealing with food and feed hygiene and the rapid alert system. In relation to the moratorium imposed in April 2012, there was the following evidence:
“Q623 Chair: If I can add a rider to that, we understood that the temporary ban was dependent on a final decision as to whether there were any health risks or not. When are we expecting that final study to be available? Bernard Van Goethem: As I said, the ban has existed for at least 10 years throughout the European Union. There was a clear breach of that ban here in the UK, but we have said that we will continuously ask EFSA to see if any risk is remaining. I remind you that the risk was linked with BSE, Creutzfeldt-Jakob, and scratching It is possible that the reference to "scratching" should be to "crushing", which was the verb used by Mr. van Goethem in the earlier passage quoted, but I shall assume that the transcript is correct. the bone of ruminants. There is a continuous request from our side. Q624 Chair: There is a debate going on, and we were told in October last year that the study was meant to conclude. The British Government and the British producers argued that the bone is left intact. I have seen the bone immediately after the meat has been stripped off it. The bone is intact. Why was there a delay in this moratorium being reviewed, which has led to this broader problem - particularly in Northern Ireland - and where we lost jobs in two particular constituencies? Koen Van Dyck: The report you refer to is the question that the Commission posed to the European Food Safety Authority on the safety of mechanically separated meat. There were three parts in this question. The first part was to compare the risk of mechanically separated meats, compared with regular meat, mincemeat, and meat products. We speak about mechanically separated meat from non-ruminants, so we speak about the risk linked to MSM from pigs and poultry. Because we had a discussion with member states, including the UK, who said that this low-pressure MSM is very comparable to mincemeat - the second question we asked EFSA was, ‘Can you give some criteria to differentiate low-pressure poultry and pig MSM from mincemeat?’ The third question we asked was ‘If you have criteria to differentiate between mincemeat, on the one hand, and low-pressure MSM on the other, where should we put the barrier between mincemeat with less destruction and mechanically separated meat?’ We received this opinion, so this report has been published. Q625 Chair: When? Koen Van Dyck: It was published at the end of March, and it is available on the website of the European Food Safety Authority. The main conclusions of the report, which I can highlight, were that mechanically separated meat, when produced according to the normal rules that exist, is not a safety issue. It means that it is a safe product that you can eat. When it follows the rules that are laid down in the regulations, there is not a food safety issue - again, when you speak about poultry and pigs. However, it is not possible to define criteria to separate low-pressure MSM from mincemeat, for example. We are now in the process, as already announced before, of scrutinising this EFSA advice, and then we will see what will be the next step and whether we have to lay down additional rules, or what has to be done relating to mechanically separated meat. This report is available for the public.”

Q625 Chair: When?

[53]This evidence from the Commission makes it abundantly clear that the production of desinewed meat or MSM from pigs and poultry does not raise any risk to public health. It is, in effect, an issue about labelling. The Commission believes that it must be labelled as MSM, so that the meat content of the product must be shown as 0%.[54]However, on the basis of this evidence, the position in the case of desinewed meat produced from flesh bearing ruminant bones is less straightforward. According to Dr. van Goethem’s evidence the risk arises from the crushing or scratching of bones during the production process. This view is strongly challenged by Mr. Manning of the Claimant, who says in his fourth witness statement, at paragraph 16:
“I am not a scientist, but since hearing this comment I have spoken to the BMPA [British Meat Producers Association], Trading Standards, senior ex-FSA employees and others who all share of the view that this simply does not accord with a scientific understanding of how BSE works. If the BSE agent was in the bone, then beef bones should be specified risk material and not sold into the human food chain. Since 2008, EU law has cleared beef bones for human consumption. Instead, any risk of BSE is only in the specific risk material and all such parts are destroyed as part of the specific risk material regulations.”
[55]I will return to this issue shortly. I merely observe at this stage that in written evidence submitted to the Committee in May or June 2012 by Mrs Paola Testori Coggi, the Director General of the Health and Consumers Directorate-General, she said that: “The current rules are very clear and robust. Regulation (EC) No 853/2004 defines MSM as ‘the product obtained by removing meat from flesh-bearing bones [of all species other than ruminants] after boning or from poultry carcasses, using mechanical means resulting in the loss or modification of the muscle fibre structure’. This means that any loss or modification of the muscle fibre structure when meat is recovered from flesh-bearing bones after deboning or from poultry carcasses by mechanical means, results in a product that must be considered MSM. MSM can be placed on the EU market as long as it complies with hygiene requirements provided for in the EU legislation. In addition, products containing MSM sold to the final consumer must be labelled accordingly. In addition, Regulation (EC) No 999/2001 stipulates that bones of bovine, ovine and caprine animals from countries or regions with a control or undetermined BSE risk shall not be used for the production of MSM. MSM is very sensitive to bacterial growth because of the raw material and the production process involved. Therefore strict hygiene rules apply to this product.” (My emphasis)[56]This evidence puts beyond doubt that the Commission’s stance was and remains that any loss or modification of the muscle fibre structure is sufficient for the product to be classified as MSM.[57]The Commission’s view that desinewed meat produced from flesh bearing ruminant bones presents a public health risk is based on its conclusion that desinewed meat is MSM - to which it says, correctly, strict hygiene rules are applied. However, this argument is circular. If the desinewed meat produced by the claimant is not MSM, then the risks identified by the Commission arising out of the use of bones from ruminant animals do not appear to arise.[58]However, as noted above, the TSE Risk Assessment Subgroup of the Advisory Committee on Dangerous Pathogens, appears to hold the view that the possible presence of, for example, bone marrow presents a potential TSE risk. If there is a risk that bones will be damaged in any mechanical process for the removal of meat from those bones, then there is a risk that the resulting desinewed meat may contain contaminated bone marrow.

The evidence contained in the witness statements

[59]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.[60]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.”
[61]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.[62]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.”
[63]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.”
[64]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.[65]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.[66]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.[67]He said that the old high pressure processes involved compressing the bones so that the water and marrow was squeezed out of them. The resultant purée was then passed through a 1 mm filter to remove bone particles and connective tissue. 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.

The original claims made by the claimant

[68]In its original grounds the claimant challenged the FSA’s decision to impose the moratorium on the following grounds: i) The decision was based on an error of law, namely the Commission’s view of the correct interpretation of paragraphs 1.14 and 1.15 of Annex I of the Regulation. ii) The claimant had a legitimate expectation that the FSA would not change its classification of desinewed meat without proper consultation with the industry and without providing the claimant and others with an opportunity to make appropriate representations. iii) The decision was taken in breach of natural justice: the claimant was given no opportunity of a hearing prior to the imposition of the moratorium or of seeing the evidence relied on by the Commission, and hence by the FSA. Further, the FVO auditors approached the issue with a closed mind. iv) The decision was entirely lacking in proportionality in that it was based on the FVO’s preliminary assessment of desinewed meat which was premeditated, made without any consultation or scientific analysis and yet had a sudden and disastrous impact on the claimant’s business. v) The decision contravened the duty of sincere cooperation.

The amended claims introduced by the claimant

[69]By amendments that were put forward during or shortly before the hearing, the claimant sought to challenge the FSA’s decision to impose the moratorium on the following further grounds: i) The decision was made on the basis that the Commission had the power to impose safeguard measures against the UK pursuant to Article 56 of Regulation (EC) No 882/2004. This, so far as material, required there to be a possible and widespread risk to human health, which there was not. ii) The decision was based on an error of law in that the FSA assumed that it was required to comply with the Commission’s interpretation of the Regulation, rather than to apply its own interpretation. iii) The claimant’s process at stage one is a form of boning meat, and therefore its process did not meet the first requirement of the definition of MSM, namely that the material is “flesh bearing bones after boning”. Since the material almost always involved flesh bearing bones with between about 50%-80% of the original meat still on the bone, it could not be said to have been boned.

The original subsidiary claims

[70]As I have already explained, for the reasons given in the separate judgment which I have already handed down, I have referred the questions of interpretation of paragraphs 1.14 and 1.15 of Annex I of the Regulation to the Court of Justice of the European Union. This is because I have concluded that it is not appropriate for a national court to decide them and therefore any claims based on the FSA’s allegedly incorrect interpretation of the paragraphs are not ones that I should determine that this stage.[71]Accordingly, the court cannot at this stage determine the claimant’s first challenge to the FSA’s decision.[72]In relation to the ground based on legitimate expectation, I accept the submission of the FSA that the only legitimate expectation that the claimant could have was that the FSA would apply the law correctly. If, on a true interpretation of the regulation, the claimant’s desinewed meat is MSM, then it cannot have an entitlement to be treated as if it was not, or might not have been, MSM. If the claimant is entitled to rely on an argument based on legitimate expectation, it can do so only if its position on the interpretation of the regulation is correct.[73]In my view, the claim based on a breach of natural justice must receive the same answer. The claimant has no right to consultation about the enforcement or interpretation of the law as it stands. If its desinewed meat was in truth MSM, then the claimant had no right either to produce it using the bones of ruminants or, in the case of production using the bones of pigs or poultry, to put it into circulation as anything other than MSM.[74]The argument based on lack of proportionality must also fall at the same fence. If, as a matter of interpretation of the regulation, the FVO and the Commission were correct in their conclusion as to the meaning of paragraphs 1.14 and 1.15, questions of proportionality do not arise. If the claimant and the FSA had, for several years, proceeded on a wrong interpretation of the law that could not, in my judgment, enable the claimant to recover damages on the ground that the law was not what it thought it was. Again, any claim by the claimant must be put on the basis that its interpretation of the regulation is the correct one. However, that is the question that the court has referred to the Court of Justice.[75]The argument based on the duty of sincere cooperation is, in my view, misconceived. The duty under paragraph 3 of Article 4 of the Treaty of the European Union is a duty on each Member State and the Commission to assist one another “in carrying out the tasks which flow from the Treaties”. Further, it requires Member States “to take any appropriate measures … to ensure fulfilment of the obligations arising out of the Treaties”.[76]If the Commission’s interpretation of the regulation is correct, then it was the UK government’s, and hence the FSA’s, duty to see that it was fulfilled. In those circumstances, this ground of claim would be doomed to fail. Yet again, the claimant can only succeed if its stance on the question of interpretation of the regulation is correct. Even then, I have reservations as to whether this is a provision that confers any rights enforceable at the suit of the Claimant. However, that is not a question that I am prepared to determine in the abstract.[77]For these reasons none of the subsidiary claims advanced by the claimant in its original Grounds can succeed unless the claimant is right on the issue of interpretation. Accordingly, at this stage the court cannot determine any of these claims. Determination must await the ruling of the Court of Justice.[78]I now turn to the proposed amendments.

The application to amend the Grounds

[79]The first of these proposed amendments is that the decision was wrongly made on the basis that the Commission had the power to impose safeguard measures against the UK. There is, in my view, a short answer to this. Assuming that the claimant’s argument is, in principle, correct, namely that the FSA is bound to apply the law as it believes it to be and should not yield to a demand by the Commission to apply a different interpretation, then to what relief could the claimant be entitled if the law is subsequently held to be what the Commission thought it to be?[80]The answer must be none. The reason for this is that in this situation the foundation of the Claimant’s claim can only be that it has been prevented during the period after the imposition of the moratorium from continuing to carry on activities that have subsequently been held to be unlawful. A claim has only to be framed in this way in order to be rejected. It would be clearly unsustainable on grounds of public policy. Therefore, this is another potential head of claim that can succeed only if the Claimant is correct on its interpretation of the regulation.[81]The second proposed amendment is that the decision was based on an error of law in that the FSA assumed that it was required to comply with the Commission’s interpretation of the regulation, rather than to apply its own interpretation. This ground can succeed only if the claimant’s interpretation of the regulation is correct.[82]Accordingly, since these first two proposed amendments can succeed only if the Claimant is right and the Commission is wrong about the interpretation of the regulation, and particularly since any amendment carries immediate consequences in terms of costs, consideration needs to be given as to whether any useful purpose would be served by giving permission to amend before the question of interpretation of the regulation has been resolved. I will return to this shortly.[83]The third proposed amendment, namely that the Claimant’s process did not meet the first requirement of the definition of MSM, namely that the material is “flesh bearing bones after boning”, faces two difficulties. First, it represents a departure from the case as it was initially put, which was that the claimant’s process was a “method of removing the meat from bones after deboning” (see paragraph 16 of the Statement of Grounds).[84]The second difficulty is that, if the assertion were correct, even the old high-pressure process of crushing the meat and bones to a slurry would not be capable of producing MSM because it, too, would not meet the first requirement of the definition. An argument that leads to such an obviously incorrect result must be flawed. In my view the flaw in the argument is that it involves the proposition that the process of deboning must involve the removal of the bulk of the meat that was originally attached to the bones. I do not see why this assumption has to be made; particularly, when if it is made, the result is an obviously incorrect conclusion. I therefore refuse permission for this amendment.[85]The final proposed amendment, which is the application for interim relief, was not opposed and I have already allowed this amendment.

The position if the claimant’s interpretation of the regulation is correct

[86]I have considered whether or not I should express a view about the relief, if any, to which the claimant would be entitled if its interpretation of the regulation is held to be correct. This is not a point that has been addressed directly in the FSA’s skeleton argument, presumably because it took the view that the court could not determine this question in advance of a preliminary ruling by the Court of Justice.[87]However, paragraphs 60-68 of the FSA’s skeleton provide a trailer of the types of argument that might be advanced if the Claimant’s interpretation of the regulation is correct. For example, it is likely to be contended that in the prevailing circumstances the FSA’s decision, even if subsequently held to have been based on an incorrect application of the law, was a rational one for it to take.[88]This confirms my view that it would not be appropriate for the court to embark on this exercise on an application for permission to amend in advance of the preliminary ruling from the Court of Justice. Other factors apart, the ruling of the Court may be expressed in terms that requires a further factual enquiry to be carried out before it can be determined whether or not the claimant’s process did meet whatever criteria the Court should decide to be preconditions of a product being properly classified as a meat preparation within paragraph 1.15 of Annex I, and not as MSM. If appropriate, the application to amend can be restored when the Court of Justice has delivered in its ruling.[89]This, I fear, means that the Claimant’s entitlement to final relief is a question that will not be resolved in the near future. I turn now to the question of interim relief.

The interim relief sought and the justification for it

[90]In essence, the Claimant seeks the following relief, in descending order of priority: i) That the moratorium should be lifted so that the Claimant can resume business as before. ii) That the moratorium should be lifted to the extent of permitting the Claimant to produce desinewed meat, which should not be classified as MSM, upon it undertaking not to put any desinewed meat reduced from ruminant bones into the human food chain; alternatively, to put such products into pet food for consumption by cats and dogs only. iii) A declaration that the 51 tonnes of frozen desinewed lamb can be sold as a meat preparation for pet food for consumption by cats and dogs only. iv) A declaration that its desinewed pork and poultry products are meat preparations under paragraph 1.15 of the Regulation.[91]The Claimant has been producing desinewed meat, as a meat preparation, from pork and poultry products since its authorisation by the FSA in August 2003. The authorisation was extended in July 2006 to products from lamb, and in April 2008 to products from beef. In his first witness statement Mr. Manning said that the Claimant has invested £5 million in the business, which has always been carried out with the knowledge and approval of the FSA. In the first six weeks following the moratorium the Claimant lost £720,000 in income. The ban on producing desinewed meat from ruminants has reduced the Claimant’s business by about 60%. The further limitation in relation to pork and poultry has effectively reduced the business by a further 20%. In a witness statement made in May 2013, Mr. Manning said that the steady encroachment on the Claimant’s business since the moratorium would lead to its collapse unless the situation changed. I have no reason to doubt this evidence.[92]I have already concluded that the Claimant’s position on the question of interpretation of the regulation is a strong one, and it is clear on the evidence that the Claimant’s desinewed meat produced from pork and poultry is quite different from MSM produced from those animals under a high-pressure process. I agree with Ms. Groves that to treat it as MSM is to waste a product that has many uses apart from being consigned for uses such as pet food.[93]In the light of the information about the financial consequences for the Claimant of the imposition of the moratorium, I approach this application on the basis that the Claimant is likely to go out of business in the absence of some form of interim relief that permits it to continue production of some desinewed meat without having to classify it as MSM.[94]Taking all these factors into account I consider that the Claimant’s application for interim relief, at least in relation to products produced from pork and poultry, is very strong indeed. I now turn to consider the relevant principles in order to decide whether or not the Claimant is in law entitled to such relief.

The principles governing the grant of interim relief

[95]The parties are agreed that the starting point for the consideration of what interim relief, if any, to grant is the test set out by the House of Lords in American Cyanamid Co v Ethicon [1975] AC 396. It is agreed also that the answers to the questions of whether there is a serious issue to be tried and whether damages would be an adequate remedy for either party are in favour of the grant of interim relief.[96]It is on the third issue, the balance of convenience, upon which the parties differ, although both parties accept that in a case involving public law issues the wider public and European interests must be taken into account.[97]Although I have had my attention drawn to a number of authorities, I do not consider that it is necessary to go further than to refer to the following observations of Lord Goff of Chieveley in R v Secretary of State for Transport, ex parte Factortame Ltd (No 2) [1991] 1 AC 603 at 673B-F, where he said:
“Turning then to the balance of convenience, it is necessary in cases in which a party is a public authority performing duties to the public that ‘one must look at the balance of convenience more widely, and take into account the interests of the public in general to whom these duties are owed’: see Smith v London Education Authority [1978] 1 All ER 422, per Browne LJ, and see also Sierbien v Westminster City Council (1987) 86 LGR 431. Like Browne LJ, I incline to the opinion that this can be treated as one of the special factors referred to by Lord Diplock in the passage from his speech which I have quoted. In this context, particular stress should be placed upon the importance of upholding the law of the land, in the public interest, bearing in mind the need for stability in our society, and the duty placed upon certain authorities to enforce the law in the public interest. This is of itself an important factor to be weighed in the balance when assessing the balance of convenience. So if a public authority seeks to enforce what is on its face the law of the land, and the person against whom such action is taken challenges the validity of the law, matters of considerable weight have to be put into the balance to outweigh the desirability of enforcing, in the public interest, what is on its face the law, and so to justify the refusal of an interim injunction in favour of the authority, or to render it just or convenient to restrain the authority for the time being from enforcing the law. This was expressed in a number of different ways by members of the Appellate Committee in the Hoffmann-LaRoche case [1975] AC 295. Lord Reid said, at p 341, that ‘… it is for the person against whom the interim injunction is sought to show special reason why justice requires that the injunction should not be granted or should only be granted on terms.’” ‘… it is for the person against whom the interim injunction is sought to show special reason why justice requires that the injunction should not be granted or should only be granted on terms.’”
[98]In the context of this case it seems to me that I should approach the question on the basis that it is the Claimant who must show special reason for the grant of the interim relief sought. As is well known, in the Factortame case the House of Lords granted interim relief on the basis that the substantial detriment to the public interest that would have occurred if the claimants eventually failed in their challenge to the relevant provisions of the Merchant Shipping Act 1988, and the regulations made under it, was not sufficient to outweigh the obvious and immediate damage that would continue to be caused to the claimants if interim relief were not granted and they were ultimately successful.[99]As in the present case, the grant of interim relief in Factortame meant that, if the claimants’ challenge ultimately failed, they would have been allowed to carry on business in breach of the law during the period of the interim relief. It is therefore not an answer to this claim for interim relief to say that if the Court of Justice decides the question of interpretation in favour of the Commission, the Claimant will have been permitted to carry on business in a manner that proves to be unlawful. However, that is obviously a very important factor to be weighed in the balance.[100]With these observations in mind, I now turn to the question of the grant of interim relief.

What interim relief, if any, should be granted?

[101]I have concluded, principally in the light of the deliberations of the TSE Risk Assessment Subgroup of the Advisory Committee on Dangerous Pathogens, that the balance of convenience - particularly having regard to the high public interest element - does not come down in favour of permitting the Claimant to produce desinewed meat using the bones of ruminants.[102]I am prepared to accept that the risk to public health is very low, but questions of perception are also important where matters of public interest are concerned, and in my view it is not appropriate for a national court to permit an activity proscribed by the Commission unless satisfied that any public health risk can safely and confidently be excluded. The evidence, such as it is, on this aspect does not enable me to reach that conclusion. Accordingly, in spite of the strengths of the Claimant’s case, I do not consider that the balance of convenience favours the grant of interim relief so as to allow the Claimant to continue to produce desinewed meat using the meat bearing bones of ruminants.[103]The next ground of relief relates to the 51 tonnes of frozen desinewed lamb. According to the evidence of Anne Milton MP, Parliamentary Under Secretary of State for Public Health, at a meeting on 24 April 2012 between the FSA and UK Permanent Representation officials and Commission officials in Brussels, the Commission agreed that products produced from ruminant desinewed meat before the ruminant moratorium began “could be sold through rather than be treated and disposed of as animal by-products which also reduced the impact on industry”.[104]In these circumstances I am unable to see why the balance of convenience should not be resolved in favour of the Claimant in relation to the 51 tonnes of desinewed lamb produced prior to the moratorium which is currently held in storage, provided that it is sold as a meat preparation for pet food for consumption by cats and dogs only.[105]So far as desinewed meat from pork and poultry is concerned, there is no public health risk. The only issue is about labelling. The evidence before the court suggests that the Claimant’s desinewed meat produced from pigs and poultry is significantly different from MSM produced from these animals. In the light of the factors that I have already mentioned in relation to the strength of the Claimant’s case, it seems to me that in relation to this ground the balance of convenience clearly favours the Claimant. Whilst the FSA did not concede this, its arguments against relief were, I felt, somewhat muted.[106]I will hear counsel on the appropriate form of relief, but for the reasons that I have given I consider that the court should grant interim relief along the following lines: i) Notwithstanding the moratorium imposed on 4 April 2012, the Claimant may sell the 51 tonnes of desinewed lamb meat held in storage as a meat preparation for pet food for consumption by cats and dogs only. ii) The Claimant may continue to produce desinewed meat from pigs and poultry and to sell it as a meat preparation, provided that the Claimant complies with the hygiene requirements set out in Chapter 3 of Regulation (EC) No 853/2004, paragraph 3 (save for item (b) of that paragraph). iii) The FSA is to be restrained from enforcing the moratorium imposed on 4 April 2012 against the Claimant in so far as to do so would prevent or inhibit the Claimant from acting as set out in (i) and (ii) above.[107]Although the Claimant seeks appropriate declarations from the court, I am a little hesitant about granting relief in this form whilst the principal question that underpins this claim is awaiting determination by the Court of Justice of the European Union.[108]I propose to direct that the Commission has permission to intervene in these proceedings and, if it so wishes, within 56 days of the order giving effect to this judgment to make any submissions in opposition to the relief set out above. Unless the Commission gives notice within 14 days of that order that it wishes to make such submissions, the relief granted will take effect in 14 days from the date of the order.