The EU Food-Contact Declaration of Compliance and the Flow of … on the DoC... · 2019-09-10 ·...

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.


Presenters

Rachida Semail, PartnerKeller and Heckman LLP

Brussels Office

+32 (0) 2 645 5094

[email protected]

Hazel O'Keeffe, PartnerKeller and Heckman LLP

Brussels Office

+32 (0) 2 645 5076

[email protected]

Tjoena Siere, ScientistKeller and Heckman LLP

Brussels Office

+32 (0) 2 645 5087

[email protected]

mailto:[email protected]




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


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


• 19 associates



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


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


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?


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?


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


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


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


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


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


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


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


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

https://www.google.com/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=&url=https%3A%2F%2Fwww.thebalancecareers.com%2Fmanufacturing-dress-code-4051113&psig=AOvVaw2hRL14A86x6_ipYwfFysHP&ust=1568150354371778


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


Content of DoCs

&

Tips for preparing / reviewing DoCs


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


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


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)


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)

https://ec.europa.eu/food/sites/food/files/safety/docs/cs_fcm_plastic-guidance_201110_reg_en.pdf



▪ 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



▪ 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



▪ 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


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



• 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



▪ 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


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?


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!


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



▪ 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



▪ 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


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”


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


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


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


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


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


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


Examples of inadequate wording in DoCs


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


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



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



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!!!


Relevant technical considerations when preparing/reviewing DoCs


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


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


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


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


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


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


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



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


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


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


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)


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)


• Isooctane, 95% Ethanol, and Tenax

• Tenax only required for testing above 100°C

Alternative Fatty Food Simulants


Alternative Fatty Food Simulants – Testing Protocols


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


Selection of Simulants (Known Applications)


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


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


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



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


Liability in case something goes wrong


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


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


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


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


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



▪ 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



▪ 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


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


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


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


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


Questions & Answers

Copyright © 2017 | www.khlaw.com Keller and Heckman LLP 81Copyright © 2017 | www.khlaw.com 81Keller and Heckman LLPCopyright © 2019 | www.khlaw.com 81Keller and Heckman LLPKeller and Heckman LLP

Washington, DC • Brussels • San Francisco • Shanghai • Paris

THANK YOURachida Semail, Partner

Keller and Heckman LLPBrussels Office

+32 (0) 2 645 5094

[email protected]

Hazel O'Keeffe, PartnerKeller and Heckman LLP

Brussels Office

+32 (0) 2 645 5076

[email protected]

Tjoena Siere, ScientistKeller and Heckman LLP

Brussels Office

+32 (0) 2 645 5087

[email protected]




The EU Food-Contact Declaration of Compliance and the Flow of … on the DoC... · 2019-09-10 ·...

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