EU NOVEL FOODS REGULATION Overview and Update

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EU NOVEL FOODS REGULATION Overview and Update

• Neville Craddock MA (Cantab.), CSci, FIFST
• Neville Craddock Associates
• Food Law Consultants
• United Kingdom

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Presentation Overview

• Background to concerns and questions raised
• Focus on Exotic traditional foods and
  Traditional use
• Balance customary knowledge and modern
  science
• Proportionate evidence of safety is required
• Production of valid scientific evidence
• More cost-effective administrative and scientific
  assessment process
• Feasibility of generic applications /
  authorisations
• N.B. Personal views!

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Current situation

• Original review discussion paper in 2002
• Numerous submissions on EC website
• Evaluation Report January 2004
• Currently considering a review of Regulation
  258/97
• Recent consultation on impact assessment of
  various options
• A proposed revision is expected early 2007 (?)

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Regulation 258/97 - Scope

• not used to a significant degree within EC
  (before 15th May 1997) and which fall under
• a new or intentionally modified primary
  molecular structure
• consisting of or isolated from micro-organisms,
  fungi or algae
• consisting of, or isolated from, plants and
  ingredients isolated from animals, except for
  foods obtained by traditional propagating or
  breeding practices and having a history of safe
  food use
• to which has been applied a (novel) production
  process (which) gives rise to significant
  changes in composition or structure which affect
  nutritional value, metabolism or level of
  undesirable substances
• Recommendation 97 / 618 describes scientific
  aspects for assessments

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• Does EU need a Novel Foods Regulation?

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Stronger EU Legislation post-1997

• EU food safety legislation significantly revised
  and strengthened
• Comprehensive food safety, import and marketing
  controls
• Defined, legal responsibilities to deliver safety
  throughout chain
• General Food Law 178/2002
• Business operator responsibilities for safety and
  legality
• Control authorities enforce legislation
• General Food Hygiene Regulation 852/2004
• All imports must meet EU or equivalent hygiene
  standards
• In practice, many EU practices will need to be
  applied
• Official Controls 882/2004
• guarantees from 3rd country authorities

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Stronger EU Legislation post-1997 (2)

• Labelling Directive 2000/13
• specific provisions on name of foods
• medicinal claims illegal
• new health claims rules imminent
• Food Fortification (Addition of Nutrients)
  proposal imminent
• will categorise herbal extracts as safe /
  restricted / banned
• Traditional Herbal Remedies Directive 2004/24
• Food Supplements Directive 2002/46
• Residues, contaminants etc
• heavy metals, mycotoxins - specific and general
• concept of safe food and responsibilities under
  178/2002
• Plant health protection measures IPPC et al

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Global Agreements - Trade and Safety Matters

• However food safety is one of EU highest
  priorities but control must be applied within
  global commitments to trade, development and aid
• Treaty requires policy and implementation to
  foster sustainable economic and social
  development of DCs (particularly the most
  disadvantaged) and their smooth and gradual
  integration into the world economy
• WTO requires justification where consumer
  protection laws conflict with level of safety
  acceptable in the country of origin, or exceed
  those established in international standards
• Does not appear to be case with NFR
• Applicant must prove his product meets the
  (higher) EU perceptions of safety whereas,
  arguably, balance of proof should be reversed,
  and EU required to prove that products concerned
  will be unsafe for consumption

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• Does EU need a Novel Foods Regulation?
• Despite the above comments, probably yes
• if only to avoid disparate National measures
  being re-introduced, but needs to be more flexible

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• Tradition and Customary Knowledge

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Concept of Tradition

• Tradition
• anything communicated from ancestors to
  descendants, generally by word only
• things pertaining to time-honoured orthodox
  doctrines
• long observed historic customs or usage
• handed down practices that are valued by a
  particular culture
• The tradition should have existed for a
  considerable period
• raw materials, derived foods and processes used
  should have been available, substantially
  unchanged, for several generations within culture
  concerned

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Concept of Tradition

• Traditional Use
• Time-related
• UK FAC 2 generations / 50 years
• Canada 3 generations / 100 years
• Traditional applications
• Conventional food uses versus extracts, powders
  and potions
• Exotic traditional food crops
• Collaboration between specialists essential EU
  / DCs / global
• Nordic proposal NETTOX project etc global /
  regional groupings

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Concept of Customary Knowledge

• Customary knowledge reflects
• acquaintance / familiarity with facts or range of
  less-defined information relating to habitual or
  commonly used practices (i.e. local customs)
• a broad concept that embraces both theoretical
  and /or practical understanding of an art or
  science
• includes references to a long history of food
  practices and use by indigenous populations
• includes the traditional precautions that are
  integral to safety
• In practice, individual product decisions would
  still need to be determined on case-by-case basis
  on evidence submitted in support of an application

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• What evidence is needed to define a Traditional
  Food?
• What criteria should be met?

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Evaluation Criteria for Traditional Foods (1)

• Acceptable, validated, verifiable evidence that
  food and plant or animal from which it is derived
  to show
• extended history of growth / production in 3rd
  country / geographic region (if not grown, reared
  or produced in significant quantities in EU)
• history of consumption extending over significant
  period amongst the native population of that 3rd
  country or region (if no history of significant
  consumption in EU)
• belongs to a normal diet and its history of use
  reflects consumption in a form generally-recognise
  d as a normal food or food ingredient

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Evaluation Criteria for Traditional Foods (2)

• obtained by conventional processes (e.g. water
  extraction, drying, fermentation, cooking,
  salting etc)
• comprise or is produced from plants, or parts of
  plants, that occur naturally or are derived from
  traditional propagation and
• obtained by harvesting from the wild state or
• agricultural cultivation that is traditional in
  the 3rd country or region
• comprise or is derived from animal species
  indigenous to, and occur naturally in the 3rd
  country or region (farmed or wild-caught)
• Food source and specific derivatives must NOT be
  on relevant proscribed lists of controlled
  narcotic substances, e.g. the various
  International Conventions on Narcotic Substances

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Evidence of History and Tradition (1)

• Full description of the plant / animal from which
  food has been derived
• a taxonomic and/or legal description, in
  accordance with recognised international
  practices (e.g. kingdom, division or phylum,
  class, order, family, genus, species, subspecies,
  common name, etc)
• Geographical origin and distribution of the food
  and food source(s)
• evidence of being indigenous to the 3rd country
  or region
• Cultural history of the wild plant / cultivated
  crop / animal / fish / bird
• general cultural aspects of the local tradition
  and relevant folk-lore

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Evidence of History and Tradition (2)

• food use history and traditions
• evidence of frequent, ongoing consumption over
  several generations
• handling from harvesting through storage to
  preparation
• consumption frequency and quantity patterns
• a particular focus on treatments and techniques
  necessary to ensure the safe consumption of the
  product
• scientific justification of safety of traditional
  preparation methods
• any adverse effects recorded in country of origin
  or elsewhere
• commercial status of derivative and its
  production in country of origin

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Details of Proposed Product (1)

• Description of product
• derivation from source material (e.g. whole,
  natural parts or extracts)
• method(s) by which it has been harvested, reared,
  produced, prepared, preserved, packaged and
  stored
• details of any major changes incurred during
  processing
• Statement of intended uses
• Anticipated EU consumption patterns
• sales volumes
• proposed geographical markets
• any special target consumer groups (children,
  elderly, immigrant etc)
• anticipated per capita (frequency, quantity -
  typical and ranges)

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Details of Proposed Product (2)

• Possible displacement of existing foods and any
  nutritional impact
• Name under which the food will be sold other
  essential label advice
• indication of proposed consumer information (if
  necessary for safety)
• storage and preparation precautions during /
  prior to consumption
• groups for whom product may be unsuitable or
  restrictions prudent
• Availability in non-EU countries
• details of any authorisations granted by a non-EU
  country
• any conditions applicable to such approvals
• any decision to refuse approval, and the reasons
• countries where the product is currently
  marketed, where no formal approval process is
  applicable

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Quality of Evidence Required (1)

• Must in all cases relate to final product and, as
  far as reasonably practical, each individual
  ingredient
• Sufficient to show that safety is plausible on
  basis of long-standing use and experience
• Reliable evidence from ethno-botanical and
  anthropological literature, from anecdotes /
  folklore, and scientific / non-scientific
  publications
• Affidavits or affirmations from independent,
  reputable authorities on history and use of the
  food and how they know information is valid
• Non-scientific data from national / regional
  centres of excellence, validated by national
  authority responsible for food export control

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Quality of Evidence Required (2)

• If available, or readily feasible
• evidence from recognised control laboratories
  that product, prepared in accordance with
  recommended, traditional methods, meets EU
  legislation or other International quality
  standards (Codex etc)
• a bibliographic review of safety data, plus an
  expert report and, if requested, data necessary
  for assessing the safety of the product
• evidence appropriate to the nature and
  anticipated (extreme range) consumption that it
  does not inherently contain significant levels of
  potentially harmful substances (e.g. proximate
  data, amino acid and fatty acid profiles, mineral
  / trace mineral and vitamins, and any
  anti-nutrients / bioactive phyto-chemicals of
  particular interest)
• Additional toxicity, allergenicity or human /
  animal clinical studies should only be required
  where reasonable doubts as to food safety justify
  them

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Quality of Evidence Required (3)

• Supporting dossiers must be presented
  professionally, in a standard format, if they are
  to receive timely attention.
• EU Guidance for the generation and presentation
  of data for the notification procedure should
  therefore be developed (c.f. NL and UK)
• Where it is not immediately possible for 3rd
  country to meet EU scientific or administrative
  requirements, technical and / or financial
  assistance should be provided (c.f. Regulation
  882/2004, or via other DGs)

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• Generic approvals
• Are they feasible?

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Generic Applications and Approvals (1)

• Should traditional food approvals be for single
  applicant or generic?
• different products derived from one plant or
  related group
• single application / multiple suppliers /
  locations
• indigenous crop and / or natural parts (wild /
  cultivated)
• but what about specialist breeding programmes?
• intellectual property rights?
• ethics and Fair Trade considerations?
• applications from National governments /
  institutions
• available for all operators
• legal representation in Community?

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Generic Applications and Approvals (2)

• Generic national / regional approvals could be
  facilitated by Official Control Regulation
  882/2004
• guarantees acceptable any business able to
  export any plant-based food products (providing
  the individual food is legal in EU)
• guarantees not provided / accepted cannot
  export (would need to work closely with
  authorities to upgrade national control systems)
• N.B. individual business no longer able to
  establish private schemes for direct exports to
  EU, unless the 3rd country itself meets the EU
  criteria

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Generic Applications and Approvals (3)

• Non-innovative traditional foods (products of
  biodiversity) differ fundamentally from other
  categories of innovative novel products
• Natural, long-time existence, and in public
  domain at origin
• Strong arguments from 3rd countries to treat them
  as separate entity
• exclude from scope of revised NFR, or
• develop own, distinct legislation
• Fear that NFR could generate effective monopoly
  to a single company for showing indigenous,
  natural food to be edible
• conflict with the spirit of international
  intellectual property rules
• appropriation of indigenous knowledge in disguise
  
• Strong views that Exotic Traditional Foods
  should remain in the public domain, and no
  private entity should gain privileged access to
  EU market

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Economic and Technical Feasibility for 3rd
Countries

• Revised NFR must strike a balance
• must not, and must be seen not to, compromise
  genuine food safety and EU consumer perceptions
  of it (DG SANCO role)
• must respect EUs obligations towards 3rd
  countries (EC role)
• due consideration for existing or planned
  international standards (EC)
• science on which controls are based must
  withstand peer review and challenge (EFSA role).
• DGs for Trade, Development and External Relations
• significant political / economic role to ensure
  3rd countries are not disproportionately affected
  by its actions
• must be fully integrated into the approval
  process for traditional 3rd country foods
• Must not prejudice EFSA independence

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Economic and Technical Feasibility for 3rd
Countries

• Cost of full technical dossier can be prohibitive
  for 3rd country operators
• Administrative demands must be minimum
  commensurate with meeting necessary scientific
  rigour
• NFR must be drafted to require proportionate
  approach to risk
• DG Sanco should ensure this by formulating
  appropriate briefs to EFSA
• Commission i.e. all relevant DGs - must ensure
  widest range of scientific, economic and all
  other information is taken into account when
  developing the risk management policies
• Revised NFR and DG Sanco, when applying it, must
  provide technical assistance to mitigate
  practical and financial impacts on DCs

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• Possible mechanisms?
• EC has suggested a single, centralised risk
  assessment and authorisation procedure is this
  appropriate?

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Customary Knowledge meets Modern Science

• Precautionary approach in EU
• understandable given past history of safety
  issues and concerns
• nevertheless, can be disproportionate for 3rd
  country foods
• Recommendation 97/618 is too strictly applied (GM
  focused)
• ignores customary knowledge and likely EU
  consumption
• is used to seek absolute safety (never
  possible!)
• Proportionality EU can learn from Australia /
  New Zealand Canada
• Possible way forward
• need new Guidelines on Risk Assessment of non-GM
  novel foods
• must deliver proportionate and focussed approach
• consider extending QPS concept to plant-based
  foods

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Can Modern Science meet Customary Knowledge?

• Initial evaluation by EC, assisted by MS
  experts (not scientific risk)
• global history and customary knowledge of the
  food
• traditional preparation methods and consumption
  patterns
• Balance uncertainty against realistic estimate of
  likely EU consumption
• estimate chance / level of any potential risk
• identify type / depth of additional evidence (if
  any) needed to
• establish acceptable level of risk or
• justify any restrictions on product availability
• Focus on intrinsic properties, not contaminants
  due to inadequate hygienic handling and storage
  (control is legally essential part of food trade)
  

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Initial Evaluation Outcomes

• Balance anticipated potential risks against
  envisaged consumption
• Initial evaluation will lead to 3 scenarios
• SAFE wholesome, toxicologically and
  nutritionally acceptable (taking into account
  specific precautions and likely consumption)
• GENERALLY SAFE except for one or more identified
  aspects requires further assessment of these
  specific areas (case by case)
• NO EXPERIENCE more extensive safety assessment
• Refer only genuine aspects of scientific
  uncertainty for EFSA assessment

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EFSA Assessment Outcomes if referred

• EFSA provides formal Scientific Opinion for MS
  SCFCAH to consider
• Authorisation procedure will lead to 3 scenarios
• SAFE may be placed freely on the EU market
• subject to general food legislation and
  safeguard procedures
• ACCEPTABLE SAFETY LEVEL (reasonable certainty
  of no harm)
• one or more risk parameters identified, can be
  managed by appropriate case by case risk
  management mechanisms
• specified labelling based on perceived risk
• post-market monitoring based on perceived risk
• REJECTED not permitted on EU market

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• Conclusions

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Key Conclusions (1)

• Excessive and prohibitively strict criteria being
  used to assess safety, disproportionate to
  potential risks
• Scientific proof demanded should be commensurate
  with perceived risk and take account of likely EU
  consumption patterns
• Insufficient consideration is given to global
  history of use or comparison with other foods
  with known, safely-managed risks
• Must consider globally-available, relevant
  evidence and assessments
• The principles in the Official Controls
  Regulation could be extended to cover
  non-scientific assurances from 3rd countries
• Foods with history of safe consumption, wherever
  this may be, should be subject to notification
  procedure and only referred for fuller, focussed
  scientific assessment if specific, valid safety
  doubts are raised

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Key Conclusions (2)

• QPS approach to plant foods should be explored
  further
• Need clear definitions and consistent application
  of all concepts
• clarified by new EU implementation guidelines
• Separate category for 3rd country traditional
  foods would enable introduction of proportionate
  pre-market evaluation procedure
• Additional labelling only in exceptional
  circumstances, if essential to provide specific
  information for clearly identified consumer
  groups.
• Post-market monitoring limited only to cases
  where risk assessment determined that low level
  of consumption was safe but higher levels might
  be a potential cause for concern in defined
  sectors.

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Key Conclusions (3)

• The practical implementation of the Regulation
  runs counter to WTO rules and appears to risk
  creating a non-tariff trade barrier against
  traditional, 3rd country products, and impeding
  the economic development of sectors and countries
  concerned
• The impact of a revised NFR should be mitigated
  by providing financial or other technical aid to
  potential exporting countries
• All evaluations should be performed at Community
  level.
• All decisions should be placed on a public
  register
• Potential for National / regional generic
  approvals should be considered

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LADIES and GENTLEMEN Thank you for your
attention!Comments Questions Discussion
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Neville Craddock AssociatesTun House 28 High
Street BletchingleySurrey UKnevillecraddock_at_tu
nhouse28.fsnet.co.ukTel 44 (0) 1883 740
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