Craig Simpson - Steptoe & Johnson LLP

EU Food Additives, Food Contact:
Regulatory Requirements and Recent
Developments 101
Craig Simpson, Senior European Legal Advisor, Steptoe & Johnson LLP
Food Contact & Additives, Washington DC, September 25, 2013
Food Additives
Food Additives: Outline
 Commercial significance?
 Basic food additives regulatory framework
 New Union lists of additives
 Authorization procedure (common)
 Implications of re-evaluation of food additives
Implications of non-compliance
 Regulation 178/2002 (Article 17(1)): ‘Food and feed business operators at all stages
of production, processing and distribution within the businesses under their control
shall ensure that foods or feeds satisfy the requirements of food law.’
 Case-315/05 (Lidl Italia):
 MS national laws can impose liability on distributors for non-compliant product
labeling (of manufacturer)
alcoholic strength of herbal liqueur
Court did not appear to address Lidl’s defense argument that: ‘The
distributor cannot know whether or not the label affixed to the packaging by
the producer contains true information.’
Are food additives on permitted lists for food and use?
Use conditions (dosage?) complied with?
Business interruption
EU compliance guarantees and indemnities from manufacturers?
Food Additives within the EU Regulatory Framework
Food Ingredients
Food Improvement Agents
Common Authorization Procedure
(Regulation 1331/2008)
Other ingredients:
positive lists,
labeling, etc. in food
specific or generic
food regulations
Regulatory Framework: Basics
 What are we talking about? ‘Additives’:
not normally consumed as food in itself
intentional addition for technological purpose (colors, sweeteners, stabilizers etc.)
not enzymes or flavorings (parallel authorization laws)
overlapping functions?
 Regulation 1333/2008 on food additives:
consolidates previous framework and sectoral directives (colors, sweeteners other additives)
new additives uses covered (e.g. in enzymes)
 ‘General conditions’ for additives:
no health risk at levels proposed
technological need unachievable by other means
consumer not misled (‘natural’, freshness)
demonstrated consumer advantage
Regulatory Framework: Basics
 Additive entry on positive list must:
 state what foods can be used in
 state what conditions under which may be used
 any restrictions on sale (e.g. specific labeling)
 Lowest use level to achieve effect – consider:
 ADI (amount ingestible over life without health risk)
 probable intake (from all sources and by special groups (children, diabetics))
 Obligation on food additive producers and users to:
 report information suggesting health risk
 provide Commission with actual use information (exposure assessment) on request
Union (Permitted/Positive) Lists
 New Union positive lists (Regulation 1333/2008 Annexes) applicable since 1 June 2013!
 Review compliance with ‘general conditions’ and drop non-compliant
 Significance for industry:
new restrictions on use (foods, amounts)
restriction of food color lycopene (E 160d)
some additives banned
colors Red 2G (E 128) and brown FK (E 154) banned
new additives allowed (marketing opportunities?)
new glazing agent for food supplements
Example of List Entry for Specific Food
Authorization Procedure
 New authorization procedures (implementing Regulation 234/2011)
 Individual additive case by case, not combined
 Procedure:
application (dossier) by ‘interested party’ (supply chain, NGOs, competitors?) to Commission
for additive ‘update’ (add, remove or restrict/extend use conditions) containing:
risk management and risk assessment data
demonstrate satisfaction of general requirements
evidence of efficacy for intended effect
no express requirement to produce unfavorable data
dietary exposure assessment
proposed maximum use levels
Commission requests EFSA risk assessment, except where deems no health risk
Authorization Procedure/Confidentiality
 EFSA opinion in 9 months:
dietary exposure assessment looking at other possible sources and special groups
whether exceeds ADI
overall risk assessment
 Commission risk management decision on update in 9 months: EFSA opinion,
Community law and ‘other legitimate factors’ (societal, economic, traditional,
ethical, precautionary principle and feasibility of controls)
 Confidentiality:
Commission decision on application
3 weeks for applicant to withdraw if refused
confidentiality precluded for use or safety data (valuable toxicological test data?)
full copies of original unpublished studies required
altered balance: transparency trumps confidentiality?
no data protection period compared to other regimes – biocides, REACH, health claims
New Authorization Case Study: Steviol Glycosides
 Paraguayan plant extract 300 times sweeter than sugar (E 960)
 EFSA March 2010 opinion:
establishes ADI
likely exceeded at maximum proposed use levels
 Commission Regulation nevertheless allows:
importance of stevia to energy reduced products (sweetness without sugar energy for
reduction in proposed use levels in soft drinks as main source of dietary exposure
energy reduced or without added sugar products only
producers and users to provide use information for future refined risk assessment
Re-evaluation of Food Additives
 The unnoticed ‘REACH’ of food law
 Concerns:
1970s evaluations based on assumptions
potential for certain additives to exceed ADI
already re-evaluations on risk basis (tartrazine, allura red)
 Regulation 257/2010 programme for re-evaluation
undertaken by EFSA
all additives last evaluated prior to January 20, 2009
colors: by end 2015, sweeteners: by end 2020, others: by end 2018
prioritization ad hoc where new risk evidence (for example, aspartame)
Re-evaluation of Food Additives
 EFSA ‘open call’ for ‘any interested party’ to submit all relevant data by deadline
failure to submit information within deadlines may result in removal from Union list (‘no data,
no market’)
joint submission optional: no REACH SIEF equivalent
reliance on data submission of competitors?
‘Food color ethyl ester of beta-apo-8’ – carotenic acid (C 30) (E 160f) is not offered any more by the
manufacturer and re-evaluation of this substance by the Authority is no longer supported by the
business operators. Therefore, this additive should not be included in the Union list.’ (Regulation
1129/2011, Recital 16)
 EFSA will consider ‘all relevant data’:
original dossier
original EFSA/SCF Opinion
new data from industry, Commission and MSs
literature search
 March 27 call for data:
15 additives: deadline of July
36 additives: deadline of November
Re-evaluation Case Study: Aspartame
 200 times sweeter than sugar, authorized for low calorie foods
 EFSA assesses new studies suggesting cancer and preterm birth links: no ADI change
 Nevertheless, Commission requests in May 2011 full re-evaluation by July 2012
 Call for data end May 2011 produces 600 studies papers (published and unpublished)
 EFSA Opinion now delayed until November
 Commission anticipates new maximum levels and mandatory warnings
Food Contact Materials
Food Contact Materials: Legislative Framework
 Requirements for all food contact materials: ‘Framework’ Regulation 1935/2004
 Legislation on specific groups of materials and articles (glass, paper, etc.)
 Legislation on specific substances – Bisphenol A example
 National legislation where no EU harmonized legislation
 Aims:
free movement of goods (removal of trade barriers within EEA)
consumer health (no migration into foods in unacceptable quantities)
 Defines ‘food contact materials’ as:
 materials and articles, including active and intelligent food contact materials, which in their
finished state
are intended to be brought into contact with food
are already in contact with food and were intended for that purpose
can reasonably be expected to be brought into contact with food or to transfer their constituents to food
under normal or foreseeable conditions of use
 ‘in their finished state are intended’ – scope grey area
Framework Regulation 1935/2004: Scope and Minimum
 Default ‘catch-all’ Article 3: in absence of specific legislation
Food contact materials shall be manufactured in compliance with good manufacturing practice
so that under normal or foreseeable conditions of use, they do not transfer constituents to food
in quantities which could:
endanger human health;
bring about unacceptable change in composition of food; or
bring about deterioration in the organoleptic characteristics
Framework Regulation 1935/2004: Specific Measures
 List of groups of materials and articles which may be covered by ‘specific measures’
(Annex I) (* = measures already adopted)
1. Active and intelligent materials and articles*
10. Plastics*
2. Adhesives
11. Printing inks
3. Ceramics*
12. Regenerated cellulose*
4. Cork
13. Silicones
5. Rubbers
14. Textiles
6. Glass
15. Varnishes and coatings
7. Ion-exchange resins
16. Waxes
8. Metals and alloys
17. Wood
9. Paper and board
 Unharmonized national measures (consistent with EU laws) permitted in absence of
specific measures
Framework Regulation 1935/2004: Specific Measures
 Specific measures may be adopted, such as:
 positive list of authorized substances for use in manufacturing (specific restrictions)
 specific limits on the migration of specific substances into food and overall limits on the migration
of substances into food
 specific provisions protecting human health
 basic rules for checking compliance
 rules for sampling and methods of analysis
 specific provisions for traceability; publicly available Community Registers
 additional labelling provisions (i.e. active and intelligent materials)
 adapting general authorization procedure laid down in Framework Regulation (individual/for the
 Substance authorization conditional on final material or article satisfying catch-all
Framework Regulation 1935/2004: Other Requirements
 Materials and articles to be accompanied with written declaration of compliance:
available to enforcement authorities
national laws requiring same outside specific measures?
 Traceability system
one up, one down supplier/DU identification system
labeling number system
facilitate recall, attribution of responsibility for non-compliance
 Labeling:
‘for food contact’
instructions for safe use
in local language
Specific Legislation Case Study: Plastics -- Overview
 Specific plastics legislation: Regulation 10/2011
 Scope:
 Bulk plastic, Plastic multi-layer and Plastic layer(s) in multi-material multi-layer articles (also if
printed or coated)
 Without prejudice to EU and national provisions on printing inks, adhesives or coatings
 Union (positive list) of substance categories permitted to be intentionally used in the
manufacture of plastic layers in plastic materials and articles, subject to specific
derogations, e.g.:
polymer production aids other than those listed, subject to national law
colorants and solvents, subject to national law
polymeric additives and starting substances
non-intentionally added substances
aids to polymerization
additives in the provisional list, subject to national law
Specific Legislation Case Study: Plastics -- Migration
Limits/Functional Barrier
 Specific Migration Limits per substance:
 specific migration limits (mg/kg) in Annex I
 generic specific migration limit of 60 mg/kg
 if used also as food additive or flavoring, not in quantities having technological effect and
exceeding food additive or flavorings maximum levels
 Overall Migration Limit (total constituents limit):
 not exceeding 10 mg per dm2
 stricter for foods intended for children
 Functional barrier concept for plastic multi-layer material/article:
not in direct contact with food
exempted from Plastics Regulation restrictions (except vinyl chloride monomer)
can use substances not on Union/provisional list, except CMRs/nanoform
but… still specific and overall migration limits for final material or article
 Functional barrier concept for multi-material multi-layer material or article:
similar but not subject to migration limits under Regulation (national law?)
Specific Legislation Case Study: Plastics -- Declaration of
 Expanded declaration of compliance requirement:
 not only for materials or articles…
 products from intermediate stages of manufacturing
 substances ‘intended for manufacturing’ (how far back in supply chain?)
 Renewable if substantial composition or production changes resulting in migration
changes or new scientific data
 Documents supporting compliance to be available to authorities (testing, calculations
including modeling, evidence on safety)
Recent Court Judgment on Rights of Non-Applicants
 European General Court judgment Case T-262/10:
inclusion of substances in positive list of additives for use in food contact materials
rights of third parties where authorisation benefits not only applicant
annuls Commission Decision to ban additive on sole basis of applicant withdrawal
must decide on authorisation if no procedural option for others to take over, or make new,
Legislation on specific substances
 EU temporary Bisphenol A ban in polycarbonate plastic infant feeding bottles (Directive
 leaching of BPA when bottle heated
 national French and Danish bans (despite EU limits not exceeded)
 EFSA Opinion that TDI still safe but some scientific uncertainty (precautionary principle –
 stricter national bans in France (all food contact applications), Sweden and Belgium (food
packaging marketed to under 3 yrs.)
 Next EFSA opinion expected November – ban lifted, or permanent?
Legislation on specific substances
 Control of imports of polyamide and melamine plastic kitchenware from China and Hong
 exceed permitted Plastics Regulation migration limits of primary aromatic amines (‘PAA’) and
 followed several alerts no Rapid Alert System for Food and Feed
 requirement for importers to:
have declaration of compliance and test results that meet migration limits
give prior notice of arrival of imports
Member States to designate points of first introduction through which imports may enter EU
documentary, identity (visual inspection) and physical checks (sampling)
Nanomaterials: Food Additives
 Former EU institutional debate about whether existing legal framework addressed nanomaterials
 Emergence of EU food law provisions specifically requiring separate risk assessment and labeling of
 Food Additives (Regulation 1333/2008):
additives already on positive list require new entry/change in specifications (considered new additive) where change in
particle size
additive producers to inform Commission of new scientific and technical information affecting safety
 Food Information Regulation (1169/2011):
labeling of engineered nanomaterial ingredients (‘nano’) (including food additives) from December 2014
first definition of engineered nanomaterials in EU food law:
….but different to Commission recommendation on the definition of a nanomaterial (2011/696/EU) weeks before:
‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or
that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order
of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain
properties that are characteristic of the nanoscale.
Properties that are characteristic of the nanoscale include:
(i) those related to the large specific surface area of the materials considered; and/or
(ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material;
‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as
an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the
size range 1 nm-100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution
threshold of 50 % may be replaced by a threshold between 1 and 50 %.
By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions
Commission anticipates aligning with recommendation (common legislative basis)
Nanomaterials: Food Contact
 No specific provisions in Framework Regulation (although covered equally)
 general obligation to inform the Commission of new scientific or technological information
‘which might affect’ authorized substance safety assessment - ‘if necessary’ EFSA to review
safety (Article 11(5))
covers nanomaterials?
relies on judgment of business operator to inform and of EFSA whether to review
 Specific provisions in Plastics Regulation:
 ‘substances in nanoform shall only be used if explicitly authorized and mentioned in the
specifications in Annex I’ (Article 9(2))
nano titanium nitride only additive specifically authorized in nanoform
carbon black and amorphous silica on Union list with nanoscale specifications
also applies to substances derogated from Union list?
 non Union/provisional listed substances cannot be used even if behind a functional barrier if
nanoform (Articles 13 and 14)
 no definition of nanomaterials
Nanomaterials: Food Contact Additives
 EU based distributors, retailers in supply chain liable for non-compliance of food
additives/food contact regulations
business interruption consequences
compliance guarantees
 Overhaul of food additives legislation
 new positive lists and authorization procedure for updating
new opportunity or potentially more restrictive regime?
strategic commercial use?
 dossier requirements favor transparency over confidentiality – protection of valuable test data?
 Ensure that your key additives are supported through additives re-evaluation process
(‘no data, no market’)
 Compliance with general food contact requirements, those established for specific types
of material, plus national requirements
interpretational gray areas remain
 Protection of companies relying on food additive authorization applications of others?
 Temporary substance bans for food contact use – precautionary principle justified?
 Emergence of separate risk assessment/authorization requirements for nanomaterials in
additives and contact materials legislation
Steptoe Food Practice
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