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Impact of Re-evaluation of Food Additives – the manufacturer’s perspective
Anders Liljegren Roquette
Informa Life Sciences' Inaugural Conference on Food Ingredients Regulations, Barcelona, September 2014
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What are specialty food ingredients?
Specialty food ingredients typically preserve, texture, emulsify, colour and improve the nutritional profile of processed food.
Specialty Food
Ingredients
Specific fats,
omega 3
Fibres
Specific proteins
Vitamins
Additives
Cultures
Minerals
Enzymes
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Staple Ingredients
flour, starch, rice, sugar, oils, coffee, cocoa, meat, milk, eggs etc.
…tasty, pleasant to eat, safe, healthy,
affordable
Informed choice
Safe and healthy diet
The importance of specialty food ingredients in the food chain
Farmers, Traders
Primary Food Processors
Food Industry Retailers Consumers
enable
Specialty food ingredients have technological and/or functional benefits. They are essential in providing today’s consumer with a wide range of tasty,
safe, healthy, affordable, qualitative and sustainably produced foods.
Specialty Food Ingredients Industries
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R&D investments
3-8%
90,000 employees
An industry contributing over
€ 40 billion
the annual turnover of EU food and drinks industry
… 200 international and national specialty food ingredients
companies
The ELC at a glance
40 members,
representing more than…
€ 1 trillion Annual turnover EU food
and drinks industry Specialty Food Ingredients
are present in almost all processed foodstuffs, thus contributing to the competitiveness of the European
food and drink industry, the largest manufacturing sector in the EU in
terms of annual turnover
* < 250 employees and TO < € 50 m.
These are guesstimates 2013, based on internal data gathering amongst our diverse membership (CEFIC is a member of ELC but is excluded from calculations due to unclear representation of industrial chemicals vs specialty food ingredients).
About
22% SMEs*
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The ELC at a glance
70%
12%
18%
Food additives representation(estimate)
The opportunity
Re-evaluation in practice Safety evaluation
Risk management
Potential impact of the re-evaluation process
Towards a successful process?
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The Opportunity
(Re)build consumer trust in food additives – Safety evaluation based on recent evidence, and risk-based
– Adequate risk communication
– Consequent risk management decisions
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Unclear procedure Inconclusive opinions Confusion in market
In Practice: safety evaluation
Requirements : towards re-authorisation?
Focus on new
scientific information
(2006)
Full dossier approach
(2013)
Statement on QS
Additives
(2014)
Variable level of data required
EFSA questioning « old » scientific data
Suggestions: EFSA guidance, standard calls for data
Requirements need to be proportionate and
applied equally!
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In Practice: safety evaluation
Data collection
Generic authoris
ation
Who is dataholder ??
Complex templates
SMEs lose
interest
Lack of data, lack
of response
Difficult coordination Inconclusive opinions Intake overestimates
Suggestion: make calls for interest the standard, simplify templates
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In Practice: safety evaluation
Work programme and prioritisation
Calls for data EFSA work
programme
EFSA work programme
Legal deadlines
Time lag between submission of data and actual reevaluation
Difficult anticipation and delays
More structure and predictability!
Suggestions: evaluation timeline; feedback to respondents
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Data submission:
In Practice: safety evaluation
1st call 2nd call Evaluation
• Evaluation timeline?
- Publication of data?
- Identity of respondents?
Criteria for 2nd/3rd public calls? Consultation of respondents?
Confidentiality? Procedure for additional info?
Efficiency of procedure impacted Communication risks
The procedure should favour cooperation!
Suggestions: standard procedure, consultation, dialogue
Safety evaluation procedure: progress made
Publication of the EFSA draft working programme
Open session of ANS panel plenary
WG/technical hearing participation on invitation
Disclosure of interested parties in call for data
Plan for update of the Food Additives Intake Model
Stakeholder meeting
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Industry welcomes these initiatives!
Suggestion: make them standard procedure
In Practice: risk management
Ca 40 opinions published (until 2014): – 13 subject to calls for new (exposure) studies
– < 30 definitive
Measure taken:
Restriction of use: certain colours
Measures under consideration:
Amendments to specs
Removal of 1 additive from list (no data)
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In Practice: risk management
Further restrictions of use and removals are likely, due to: - Emerging scientific data – fully legitimate
More problematic: - Intake overestimates - Lack of (tox) data = inconclusive opinions
Risk of major market impact
Risk of nurturing consumer mistrust
Suggestion: launch reflection on the final objectives of the exercise
Potential impact of the re-evaluation process
On EU industry:
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Direct impact in market
Confusion in market
Impact on manufacturer
Negative or inconclusive
opinion
Multiple calls for
data
Amdmts to specs
Impact in market prior to risk management measures
Risk communication is
vital
Suggestion: share draft opinions with respondents
Potential impact of the re-evaluation process
On the consumer: – Building trust in EU food safety…
– Or nurturing mistrust?
Mistrust can have repercussions on whole food safety system
Shared responsibility to avoid such situation:
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Manufacturers Food Industry
EFSA Commission
Potential impact of the re-evaluation process
On a global scale:
– Re-evaluation is observed by third countries
– Will it affect international standards and trade? •E.g. Substantial deviations from Codex norms?
– Will other jurisdictions follow the EU ?
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Conclusion: towards a successful process?
1.Recognition that revamp of procedure is needed
2.Initiatives for enhanced cooperation: on the right track, provided efforts are sustained
1. Stakes higher than expected
2.Re-evaluation process merits fundamental rethink: all main actors involved
Success means a predictable, transparent and proportionate process!
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Thank you for your attention
www.elc-eu.org
