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Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 1Copyright © 2017 | www.khlaw.com 1Keller and Heckman LLPCopyright © 2019 | www.khlaw.com 1Keller and Heckman LLP
The EU Food-Contact Declaration of Compliance and the Flow of Information in the Supply chain
10 September 2019
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Preliminary Word
The information provided in this presentation is drawn entirely from public information. The views expressed in this presentation are the authors’ alone and not those of the authors’ clients.
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Presenters
Rachida Semail, PartnerKeller and Heckman LLP
Brussels Office
+32 (0) 2 645 5094
Hazel O'Keeffe, PartnerKeller and Heckman LLP
Brussels Office
+32 (0) 2 645 5076
Tjoena Siere, ScientistKeller and Heckman LLP
Brussels Office
+32 (0) 2 645 5087
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Brief introduction of KH
▪ Law firm with headquarters based in Washington, D.C.• Founded in 1962
▪ 4 other offices: • Brussels (1992)
• San Francisco
• Shanghai
• Paris
▪ Total attorneys: 75 (+ many other regulatory specialistsand paralegals)
▪ Total scientists: 22
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Brief introduction of KH
▪ Well recognized worldwide main
practices:
• Food packaging
• Chemical control
• Food
▪ Zoom on the food packaging group:
• 12 full-time partners
‒ 2 in the Brussels office
• 15 scientists (13 full-time and 2 part-time)
‒ Unique to KH
‒ Various areas of scientific expertise
‒ 2 in the Brussels office
• 19 associates
‒ 2 in the Brussels office
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Types of services rendered to clients
▪ Compliance assessment and issuance of opinion letters
▪ Test protocols
▪ Petitioning for new substances• EU (EFSA) and national level (e.g., BfR, G4 Commission)• US• China• Japan• Mercosur
▪ GMP auditing
▪ Product Recall and Liability
▪ Advocacy papers
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Agenda
▪ Basics on DoCs: What are Declarations of Compliance (DoCs)? Why DoCs? What is the legal basis for the obligation to issue them? Who should issue a DoC?
▪ Content of DoCs and tips for preparing and reviewing DoCs
▪ Relevant technical considerations when preparing/reviewing DoCs
▪ Liability in case something goes wrong
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Basics on DoCs: What are Declarations of Compliance (DoCs)?
Why DoCs?
What is the legal basis for the obligation to issue them?
Who should issue a DoC?
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What is a DoC?
▪ A DoC is a written document confirming compliance of a
food-contact (FC) substance, intermediate material or final
material or article with the applicable FC legislation
• FC substance?
• FC intermediate material?
• FC final material and article?
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What is the legislation to comply with?
EU Framework Reg. 1935/2004EU GMP Reg.
2023/2006
Paper and
Board MetalsAnd
AlloysPrinting Inks
Future EU Regulation on
biocides in FCM???
Coatings
Adhesives
Silicones
Cork
Ion-Exchange Resins
Wood
Waxes
Rubber
Glass
Mutual recognition applies in non-harmonized areas
Other EU measures for specific materials or substancese.g., Plastics Reg. 10/2011
Recycled Plastics Reg. 282/2008Regenerated Cellulose Dir. 2007/42
Active and Intelligent Packaging Reg. 450/2009Ceramics Dir. 84/500 …
Textiles
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Convertor
Food packer/
Food packer 2
Printing inksAdhesives Paper Coatings Over print Varnishes
Pre polymersAdditivesPulpRecycledpaper
polymers Solvents
Food packer 3
Food company Food company Food company
Why DoCs? Complexity of supply chain
Printing inks
Promotion articles
Secondary packaging
Tertiary packaging
Adhesives
Food packer/Food company
Convertor/
Plastics
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Why DoCs? Need to transfer information
▪ Two main aims of DoC:
• Confirms to the customer compliance of the M&A with relevant
requirements
• Provides the customer with relevant information to allow them to
establish or check compliance of his product for ultimately
ensuring that the final product is compliant
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Legal basis for the DoC requirementEU Law:
▪ Under Article 16 of the Framework Regulation, “Specific Measures”
adopted at the EU level must include a DoC requirement
• Article 15 of Plastics Regulation
• Article 2a of the Ceramics Directive
• Article 6 of the Regenerated Cellulose Films Directive
• Article 12 of the Active and Intelligent Packaging Regulation
• Article 4 of the BPA Regulation (varnished & coated materials & articles)
National laws:
▪ For materials and articles not covered by “Specific Measures” at the
EU level, Member States are permitted to adopt national provisions for
DoCs
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DoCs need to be substantiated
▪ DoCs trigger liability
▪ Obligation to substantiate DoCs and to keep this supporting information in-house to make it available to enforcement authorities on demand
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Validity period of a DoC
▪ No specific time set in the EU legislation
▪ Per Plastics Regulation, DoC to be renewed when substantial changes in the composition or production that would bring about changes in the migration from the FCMs or when scientific data becomes available
▪ Certain Member States have set a validity period
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Form of delivering the DoCs
▪ Not specified in legislation
▪ DoC does not necessarily need to be physically attached
or accompanying the goods sold repeatedly to a customer
• Paper form or electronic format
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Who should issue DoCs?
▪ Operator supplying FCMs at marketing stages other than retail stage
• Manufacturer in EU
‒ of a substance
‒ of intermediate materials
‒ of final materials and articles
• Importer in EU of third-country products
‒ Has the same obligations as a manufacturer in the EU
• Distributor in EU
‒ Either forward information from suppliers’ DoCs with cover letter identifyinghis role in supply chain or to compile his own DoCs based on suppliers’ information
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Potential Implications of Brexit
▪ Business operators in EU27 importing from UK would
assume the role of EU importer after Brexit (assuming UK
exits EU Customs Union)
• Placing FCM on the EU market for the first time
• Must issue his own DoC even if just distributing (unless selling
to retailer)
• Must maintain documentation on file supporting compliance of
FCM with applicable requirements
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Content of DoCs
&
Tips for preparing / reviewing DoCs
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What information should a DoC contain?
▪ Annex IV of the Plastics Regulation details what information should be included in DoCs for plastic M&A
↓
Further explanations in the EC’s Guidance document on the DoC
↓
A good reference guide re what information should flow through the supply chain for other M&A also
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Content of DoC
▪ Possible content of DoC
• Identity and address of business operator issuing the DoC
• Identity of M&A
• Date of declaration
• Confirmation of compliance with relevant requirements of the
Framework Regulation
• Confirmation of compliance with national legislation and/or
reliance on the mutual recognition principle
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Content of DoC
▪ Adequate information regarding substances used or their
degradation products subject to specific restrictions/specifications
▪ Adequate information regarding dual use additives, which are
subject to a restriction in food
▪ Specification regarding use of material (e.g. types of food,
temperature, time, the highest food contact surface area to volume
ratio covered by DoC)
▪ Conformity of functional barrier with requirements (if used)
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EC Guidance on the DoC
▪ Selection of Recommendations from European Commission (EC)’s Guidance Document on the DoC
▪ How to Protect Trade Secret Information and some other Common Challenges
• Reference: Guidance in “Union Guidance on Regulation (EU)
No. 10/2011 on plastic materials and articles intended to come
into contact with food as regards to information in the supply
chain” (https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf)
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EC Guidance on the DoC
▪ Published on 28 November 2013
• Guidance = not legally binding
▪ Intended to assist operators in the plastics sector as
regards the information that would need to be
communicated between operators
▪ May be used by enforcement authorities as a guide also for
other sectors
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EC Guidance on the DoC
▪ Defines • Chemical substance • Intermediate plastic material • Intermediate non-plastic
material• Final M&A
▪ Also defines• Substance manufacturer• Manufacturer of plastic
intermediate materials• Manufacturer of non-plastic
intermediate materials• Manufacturer of final M&A• User of food contact M&A• Distributor• Importer• Retailer• Final consumer
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EC Guidance on the DoC
▪ Sets out obligations of different operators depending on their roles
• Manufacturer of substances
• Manufacturer of plastic intermediate materials
• Manufacturer of non-plastic intermediate materials (coatings, printing inks, adhesives)
• Manufacturer of final M&A
• User of M&A
• Distributor
• Importer
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EC Guidance on the DoC – General Principles
▪ ALL business operators in the chain, starting from the pure
substances, carry responsibility with regard to the compliance
of the finished article
• Whole manufacturing process must respect GMP
‒ Production of starting substances excluded from GMP
• General disclaimers without complete disclosure of the
composition of the material are NOT acceptable
• Only components (e.g., raw materials, intermediate products)
intended to be used for food contact should be used
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EC Guidance on the DoC
• Compliance work should be conducted "as high up the
manufacturing chain as possible" to avoid duplication
‒ Facilitated if customer provides information to manufacturer on end
use
• A business operator introducing a substance into a product
(e.g., raw materials, intermediate products) intended for food
contact is responsible for this substance
‒ Including the impurities of this substance and the reaction products it
may form at this or later manufacturing stage
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EC Guidance on the DoC
▪ Responsibility for compliance work can be delegated
• If a producer is unable to take responsibility for a given aspect, (e.g.,
migration), if it cannot be predicted at that given stage
▪ Delegation must be specific and must provide the customer with
information to take over that compliance work
• E.g., migration of substances X,Y, Z must be checked
▪ Undelegated compliance work automatically means acceptance
of responsibility
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Some Common Challenges with DoCs
▪ How to protect trade secret information?
▪ How to address dual use additives?
▪ What about nanomaterials?
▪ What to state about Non-Intentionally Added Substances?
▪ Does Member State legislation need to be addressed?
▪ Mutual recognition?
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How to Protect Trade Secrets in DoC
▪ Different considerations depending on which stage
business operator is at in supply chain
▪ Case Study: Polymer/resin manufacturer
• May have details of starting substances and impurities and
reaction products generated by these
• May not have full details of all end use applications
• Does not wish to pass on full formulation to customers!
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How to Protect Trade Secrets in the DoC
▪ Option 1: Conduct worst case migration calculations of
substances subject to specific migration limits or other restrictions
(assuming 100% migration of used amount of substances subject
to restrictions).
▪ Option 2: Mathematical modelling (if possible)
▪ Option 3: Conduct residual content testing and calculations based
on residual content amount
▪ Option 4: Migration testing
• CRITICAL to note parameters used for calculations or testing in the DoC
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How to Protect Trade Secrets in the DoC
▪ Option 5: May decide to identify some substances in DoC
for various reasons (e.g. not confidential, migration
exceeding SML or close to SML)
▪ Option 6: State that identities of substances can be
disclosed under a confidentiality agreement
▪ Option 7: State that they can be requested by a third
party (usually a law firm or a laboratory) under a
confidentiality agreement which will verify/confirm
compliance
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How to Protect Trade Secrets in the DoC
▪ EC Guidance on DoC:
▪ “the non-disclosure of the identity of a substance in the DoC should
be the exception and disclosure of its identity should be agreed
between business operators”
• Disclosure of the identity of the substance in the DoC is not mandatory if the
customer is informed of the presence of non-disclosed substances and
the business operator confirms that 1/10th of the restriction cannot be
exceeded up to a given material layer thickness or concentration of material
in a blend, provided the conditions of use for which compliance is calculated
or tested are clearly specified
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How to address dual use additives?
▪ Dual use additive: “a substance that is authorized as
additive in plastics and, at the same time, as food additive
or flavouring” regardless of
• Purity
• Whether substance is subject to restriction in food or plastic
FCM
(DoC Guidance)
▪ Plastics Reg: “adequate information”
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Substances in nanoform
▪ Substances (i.e. monomers/starting substances and
additives) in nanoform shall only be used if explicitly
authorized in specifications according to Plastics Reg.
▪ Non-harmonized legislation (e.g. applicable to rubber or
silicones) sometimes distinguishes substances in
nanoform from non-nano versions
▪ Some questions as to what a substance in nanoform is
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Substances in nanoform
▪ EC’s Guidance:
• Refers to Commission Recommendation 2011/696/EU of 18 October
2011 on the definition of nanomaterial
• Recommendation is currently under review but the timing for any
revisions is uncertain
▪ Our comments:
• May be helpful to explicitly address substances in nanoform in DoC
• E.g. clarify that any monomers/starting substances/additives in
nanoform used meet Plastics Reg. specs or that there are no
substances in nanoform used
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Non-intentionally Added Substances
▪ Means “an impurity in the substances used or a reaction
intermediate formed during the production process or a
decomposition or reaction product” according to Plastic
Reg.
▪ EC/EFSA: NIAS includes oligomers
• Guidance on DoC: substances used must be of a purity and
technical quality suitable for the intended use and NIAS must be
risk assessed or adequate information passed on to allow the
downstream user to assess the suitability of the substance for
his intended use
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Reference to Member State legislation in DoC?
▪ While the regulation of plastic FCMs is mostly harmonized,
polymer production aids not listed on Plastics Reg/solvents
and colorants, and substances on the Provisional List of
Additives are subject to Member State legislation
▪ Other FCMs (e.g. silicones, rubber, coatings, printing inks,
adhesives) not specifically regulated at EU level so subject
to Member State legislation and the mutual recognition
principle
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Reference to Member State legislation in DoC?
▪ Our thoughts:
• Member State legislation should be addressed in DoCs, if
necessary
• Even if components do not have suitable status in Member
States with technical requirements, it may still be possible to
lawfully market products throughout the EU based on the mutual
recognition principle
• Language could be included in the DoC re the Member States in
which the mutual recognition principle is being relied upon
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Study of Information in the Supply Chain
▪ Information flow in supply
chain not functioning well
▪ EC conducted a survey on the
use of compliance
documentation in official
controls and in the supply
chain
• Opened until Feb. 10, 2017
• Directed at national
competent authorities,
stakeholder associations,
and business operators
To be addressed in depth in ongoing evaluation of FCM legislation
Objective
▪ Identify possible problems
with compliance information
submitted in the supply
chain of FCMs, (incl.
information presented
during official controls)
▪ Correct existing legislation
& prevent difficulties in
future legislation
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Examples of inadequate wording in DoCs
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Inadequate DoC – Example 1
Dear [Customer],
We hereby certify that our XY Adhesive complies with the following:
▪ Title 21 of the FDA’s Code of Federal Regulations (C.F.R.), Section
175.105
▪ ISO 9001 and ISO 14001
Signed: John Smith, Product Stewardship Officer, the UK Adhesives
Company
Dated: 12 November 2000
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Inadequate DoC - Example 2
Dear [Customer],
“We hereby confirm that Coating X is in conformity, as ingredient in material and/or articles which may be in contact with foodstuff, with restrictions and/or obligations set out in the regulations referenced below:
EUROPE: Framework Regulation — Traceability requirements
according to Article 17
FDA:……..”
Signed: Martine Martin, Product Stewardship Officer, the Belgian Coatings
Company
Dated: 12 November 2018
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Inadequate DoC - Example 3
Dear [Customer],
▪ We hereby certify that Silicone Resin AB complies with the relevant requirements of the Framework Regulation (EC) 1935/2004 and with the GMP Regulation (EC) No. 2023/2006.
▪ It is the responsibility of the manufacturer of the final material and article to ensure that any applicable specific migration limits are met and that impurities are risk assessed.
Signed: Klaus Schmidt, Product Stewardship Officer, the German Silicones Company
Dated: 12 November 2018
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Some other Points to Remember
▪ Critically assess DoCs received from suppliers for
completeness
▪ Prepare complete/detailed DoCs for downstream users
▪ Designate professional within company responsible for
issuing DoCs
▪ Issuance of DoC results in liability!!!
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Relevant technical considerations when preparing/reviewing DoCs
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Assessing Migration
▪ Calculations (Theoretical)
• Less expensive and time-consuming
• Overestimates migration to food
• Concentration of substance in polymer layer must be
known
• Not applicable to OML testing
▪ Migration Studies (Experimental)
• More expensive and time-consuming
• More accurate representation of potential migration
• May be limited by sensitivity of analytical instrumentation
• Required for OML testing
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Calculations
▪ Usually performed as a first step in lieu of laboratory
migration testing
▪ Two main options:
• Assume 100% of the additive (or residual monomer) migrates to
food
• Modeling based on principles of diffusion
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100% Migration Calculations
▪ Need to know:• Thickness of article or layer• Density of material in which FCS is used• Concentration of substance• Food contact surface area to volume ratio
▪ Time and temperature are not relevant
▪ Size (MW) of substance is not relevant
100% Migration calculationDensity of Article x Article Thickness x Concentration of Substance in Article ÷ food contact
surface area to volume ratio = Migration
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Sample Thickness Considerations
▪ When a material is very thick or the application is unknown, a theoretical
thickness can be taken into consideration
▪ In the past, in line with EFSA’s Note for Guidance: a thickness of 250 µm
could be regarded as appropriate for articles of indefinite thickness → not
valid any longer since latest EFSA’s Note for Guidance (2017)
▪ JRC draft guidance: has provided new thicknesses that can be regarded as
worst cases. In some cases, thicknesses of 250 µm are inadequate. New
recommended thicknesses depend on:
• Polymer type
• Contact conditions
• Molecular mass of the migrant
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Information that may need to be included in the DoC
100% migration calculation
• Confirmation that compliance with the relevant requirements of substance X is based on 100% migration calculation
• Thickness of the material
• Food contact surface area to volume ratio
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Relevance of details like thickness of the material(Example from EC Guidance Document)
▪ Multilayer film (PP/PE/PP)
▪ Both PP layers are manufactured from the same PP grade supplier and it is
confirmed that the PP grade does not contain any additive with SML;
▪ The PE supplier does not want to disclose information on the additive with an
SML of x mg/kg present in the PE grade sold, but confirms that the SML will
not be exceeded by worst case calculation (100% migration) for a film
thickness of 150 µm at a given S/V ratio.
▪ The customer will be able to confirm compliance as long as the thickness of
the PE layer is 150 µm or less at the given or lower surface to volume ratio
▪ If the customer wants to use it above 150 µm, then additional communication
with the supplier is necessary
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Diffusion Calculations
▪ Conducted when 100% migration calculations exceed regulatory limits
and/or toxicity thresholds
▪ Can be done by hand for simple cases, or using commercial software
for complex cases including multilayers
▪ Generally unsuccessful for polyolefins, based on their relatively poor
barrier properties
▪ Diffusivity of the polymer layer must be well-known
▪ Time and temperature of use must be considered (more on this later)
▪ Concentration of the migrant within the food-contact layer must be
known
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Information that may need to be included in the DoC
Diffusion calculations
▪ Confirmation that compliance of substance X, which is subject to a SML, is based on mathematic modelling
▪ Food contact surface area to volume ratio
▪ Thickness of the material
▪ Time and temperature or details on end use applications covered
To be considered on a case-by-case basis
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Migration Testing
▪ Used if neither 100% migration calculations nor diffusion modeling yields satisfactory results (SML testing)
▪ Always required for OML testing• OML testing on final FCM
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Relevant Parameters for Migration Testing
▪ Sample(s) to be tested
▪ Solvents (food simulants)
• Aqueous, acidic, alcoholic, fatty
▪ Volume-to-surface area ratio
▪ Time(s) and temperature(s)
▪ Analytes and analytical methods
▪ Validation
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Food Simulants
Food Type Food simulant (Plastics Regulation)
Aqueous food 10% Ethanol (Simulant A)
Acidic food (pH <4.5) 3% Acetic Acid (Simulant B)
“Ethanolic” food 20% Ethanol (Simulant C)
Semi fatty food products 50% Ethanol (Simulant D1)
Fatty food Vegetable oil (Simulant D2)
Dry foods MPPO = TENAX (Simulant E)
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Alternative Fatty Food Simulants
▪ In cases in which technical reasons prevent the verification
of compliance in vegetable oil;
• Use of alternatives applicable only in certain situations
‒ Overall migration: excessive absorption
‒ Specific migration: reaction of migrant with simulant (primary aromatic
amines with oil)
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• Isooctane, 95% Ethanol, and Tenax
• Tenax only required for testing above 100°C
Alternative Fatty Food Simulants
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Alternative Fatty Food Simulants – Testing Protocols
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Selection of Simulants (No Specific Applications)
Simulant used for
testingCovers the following food types
A + B + D2 All food types
A + D2 All non-acidic food types
D1 All aqueous, and alcoholic foods and milk products
D1 + B All aqueous, acidic, and alcoholic foods and milk products
C Aqueous and alcohol (up to 20%) foods
B + C Aqueous, acidic and alcohol (up to 20%) foods
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Selection of Simulants (Known Applications)
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EU Times and Temperatures – SML Testing
Contact Temperature Test Temperature
T ≤ 5°C 5°C
5°C< T ≤ 20°C 20°C
20°C < T ≤ 40°C 40°C
40°C < T ≤ 70°C 70°C
70°C < T ≤ 100°C 100°C
100°C < T ≤ 121°C 121°C
121°C < T ≤ 130°C 130°C
130°C < T ≤ 150°C 150°C
150°C < T ≤ 175°C 175°C
175°C < T ≤ 200°C 200°C
T > 200°C 225°C
Contact time Testing time
t ≤ 5 min 5 min
5 min < t ≤ 0.5h 0.5h
0.5h < t ≤ 1h 1h
1h < t ≤ 2h 2h
2h < t ≤ 6h 6h
6h < t ≤ 24h 24h
24h < t ≤ 3d 3d
3d < t ≤ 30d 10d
t > 30d Specific
conditions
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Specific Conditions for Long Term Storage
Real life condition Specific test conditions
Any time frozen 10 day at 20°C
Any time refrigerated 10 days at 40°C**
≤half year at room temperature 10 days at 50°C**
>half year at room temperature 10 days at 60°C**
**Include short term heating and/or hot fill between 70°C – 100°C where the maximum contact
time should not exceed: 120
(2 Τ(𝑇−70) 10)minutes (T in °C)
Hot fill: T ≤ 100°C
Cool down < 50°C within 60 min
or < 30°C within 150 min
70°C: 120 minutes
80°C: 60 minutes
90°C: 30 minutes
100°C: 15 minutes
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Times and Temperatures – OML Testing
Plastics Regulation Intended Conditions
OM1 10d at 20°C Storage at frozen and refrigerated conditions
OM2 10d at 40°C Long time storage at RT (+ hot fill)
OM3 2h at 70°C Hot fill
OM4 1h at 100°C High temperature applications up to 100°C
OM52h at 100°C/reflux or
1h at 121°CHigh temperature applications up to 121°C
OM6 4h at 100°C/refluxAny food contact conditions with simulants A, B, C and D1
> 40°C
OM7 2h at 175°C High temperature applications up to 175°C with fatty foods
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Information that may need to be included in the DoC
Migration testing
▪ Confirmation that OML, SML (and/or QM) is in compliance with the relevant requirements
▪ End use application(s) covered (times, temperatures, food types) or alternatively, details on the test conditions applied in the migration tests
▪ Food contact surface area to volume ratio
To be considered on a case-by-case basis
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Liability in case something goes wrong
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Liability
▪ May notably arise in case of migration of food contact
components into food observed at unacceptable levels but
also when DoCs not delivered or inaccurate or incomplete
▪ To be assessed on a case-by-case basis
▪ In such cases, operators exposed to:
• Criminal Liability
• Commercial and Contractual Liability
• Civil Liability
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Legal implications in Case of a Non-Compliance
– Criminal Liability
▪ Enforcement actions taken when there is a breach to the applicable legislation, i.e., when a product is not compliantwith:• Framework Regulation 1935/2004
• EU implementing measures
• National rules
▪ Whether or not there is a safety risk
▪ Such a breach may be observed following:• Routine official controls
• Incidents, Rapid Alert System for Food & Feed (RASFF)
• Or other circumstances, such as consumers’ or competitors’ complaints
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Enforcement Actions – Criminal Penalties
▪ Competent authorities may set criminal penalties, in
addition to injunction to recall, withdraw, destroy products,
isolation or closure of all or part of business etc.
• Set at national level
• May vary from one Member State to another
▪ Severity of the penalties dependent on whether breach to
legislation is intentional or not
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A few examples of penalties
▪ Germany:
• Fine of up to EUR 50,000 when placing a FCM on the market
without a written declaration of compliance
• Fine of up to EUR 50,000 in case of failure to provide
documentation at all, correctly, completely or in time
▪ France:
• Fine of EUR 45,000 and three years of imprisonment if a
declaration of compliance is intentionally falsified
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Commercial & Contractual Liability
▪ In cases where non-compliance observed, claims from food business against food contact material/article supplier(s) for, e.g., costs and related damages for:
• Recall
• Storage
• Destruction
• Breach of contractual obligations
• Commercial losses
• etc
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Commercial & Contractual Liability
▪ Determination of liability may lead to long and difficult
commercial and contractual disputes
• Complex issues because of the numerous actors involved in the
supply chain
▪ It is clear that each FC operator in the supply chain takes
responsibility for the products as supplied to immediate
customers
• Its manufacturing process, compliance with GMP (where
applicable), traceability, specifications, selection of raw
materials used, its DoC
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Commercial & Contractual Liability
▪ Extent of liability of supplier vis-à-vis its customer would
in particular depend on:
• the requirements imposed by that customer (if any)
• largely on the information provided in particular in
the DoCs (received and issued)
• as well as on the due diligence exercised
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Commercial & Contractual Liability –Information Provided & Liability Encountered
Liability
Information
provided
The more relevant information is provided to customers,
the less liability is encountered by suppliers
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Civil Liability
▪ In case a damage occurs ➔Defective Product
Liability Directive (85/374/EEC)
• Producer shall be liable for damages caused by a
defect in his product
‒ Covers physical or material damages (non-material
damages entirely governed by national laws)
• A product is « defective » when it does not provide
the safety which a person is entitled to expect
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Civil Liability
▪ Broad definition of producer
• « Manufacturer of a finished product, the producer of any
raw material or the manufacturer of a component part
and any person who, by putting his name, trade mark or
other distinguishing feature on the product presents
himself as its producer »
▪ Responsibility without fault
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Civil Liability
▪ Joint responsibility of all operators in the production chain in favor of the
injured party
▪ 3 years for the injured party to apply to proceedings for the recovery of
damages
• Starts running from the day the plaintiff became aware, or should reasonably have
become aware of the damage, the defect and the identity of producer
▪ Certain defences for the producer
‒ In particular, « state of scientific and technical knowledge at the
time when he put the product into circulation was not such as to
enable the existence of the defect to be discovered »
‒ Some Member States do not allow this defense
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Questions & Answers
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Washington, DC • Brussels • San Francisco • Shanghai • Paris
THANK YOURachida Semail, Partner
Keller and Heckman LLPBrussels Office
+32 (0) 2 645 5094
Hazel O'Keeffe, PartnerKeller and Heckman LLP
Brussels Office
+32 (0) 2 645 5076
Tjoena Siere, ScientistKeller and Heckman LLP
Brussels Office
+32 (0) 2 645 5087