Update on Developments in Food Contact Materials Legislation in the EUGanna Zinchenko, knoell NLWaters Extractables and Leachables Forum26 September 2019, Hamburg

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General overview FCM legislation in EU

Updates concerning Plastics and Ceramics

Enforcement

Post-Brexit FCM legislation

Evaluation of FCM legislation

Agenda

FCM legislation in EU: harmonzied and non-harmonized

EUMember States

Switzerland

PLASTICSReg (EU) No 10/2011

ACTIVE AND INTELLIGENT MATERIALS Reg (EC) No 450/2009

RECYCLED PLASTIC MATERIAL Reg (EC) No 282/2008

CERAMICSDirective 84/500/EEC

REGENERATED CELLULOSE FILM Directive 2007/42/EC

BPA in varnishes and coatingsReg (EU) 2018/213

EPOXY DERIVATIVESReg 1895/2005/EC

NITROSAMINESDirective 93/11/EEC

Framework Reg (EC) 1935/2004

GMP Reg (EC) No 2023/2006

Products from China or Hong KongReg (EU) No 284/2011

Material

Substance

Origin

Paper and Board

Adhesives

Printing inks

Ion exchange resins

Varnishes and coatings

Waxes

Glass

Metals and alloys

Cork and wood

Rubbers

EU FCM legislation overview

Printing inks

EU fundamental requirements for FCM

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Framework Regulation (EC) No 1935/2004

FCM must not:- endanger human health - bring an unacceptable change in composition of food - bring a deterioration of organoleptic characteristics of food

Authorization of substances is required for materials: active and intelligent materials and articles, adhesives, ceramics, cork, rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, silicones, textiles, varnishes and coatings, waxes, wood

Requirements on labeling, traceability, DoC; active and intelligent materials

Regulation (EC) No 2023/2006 on Good

Manufacturing Practice GENERAL REQUIREMENTS

- quality assurance - quality control

- documentation for FCM and articles

SPECIFIC REQUIREMENTSfor printing inks

- substances from the printed surface are not to be transferred to the food-contact side

Guidance documents by industry associations

Plastics Europe for plasticCEPI for paper and board

EuPIA for (food packaging) printing inks

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General approach to compliance of FCM substances

National legislation

Positive/ Negative lists

• Functional barrier• not detectable limit

(<10ppb)• No CMR• No nanoform

Conservative approach: lowest

SML

Risk assessment

Authorization

Self-derived SML or SML TTC

Listed with variation

No listing

Not fulfilled

No

Yes

Union list: SML NDN/A

Worst case calculation

ORmigration testing

EU legislation

Authorization

No listing

• Functional barrier• not detectable limit

(<10ppb)• No CMR• No nanoform

NIAS

Not fulfilled

Updates: Plastics

Plastic Materials Regulation (EU) No. 10/2011 (PIM)

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Plastic materials based on synthetic polymers and/or chemically modified natural polymers

Union list (authorized substances):Monomers or other starting substances

Additives excl. colorantsPolymer production aids (PPA) excl. solvents

Macromolecules obtained from microbial fermentation

1069 substances

SMLs(mg/kg food)

Restrictions

OML10 mg/dm²

or 60 mg/kg food

Derogations:PPA

Salts of authorized acids,

phenols or alcohols

Polymeric additives

May be present in articles:NIAS

Aids to polymerizationMay be used in manufacture:

Colorants and solvents

Subject to national

legislation

Subject to safety (FWR Art.3) and risk assessment

(PIM Art.19)

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January 2019

Amendment - Regulation (EU) 2019/37• 3 new substances added• Use restrictions changed for 4 substances• Clarifications to rules for selection of simulants for milk products with

cut-off pH value 4,5

August 2019

Amendment - Regulation (EU) 2019/1338• Use restrictions changed for 1 substance

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PIM updates 2019Amendments to Regulation (EU) No 10/2011

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2018 BPA Regulation (Amendment to PIM Regulation)

Regulation (EU) 2018/213 dated 12.02.2018 setting a new SML 0.05 mg/kg and SML as ND (less than 0.01 mg/kg) for FCM intended for infants and young children.

2018-2020: Re-evaluation of BPA toxicity, new BPA hazard assessment

Feb 2018: Core study from CLARITY-BPA was published in the USSep 2018: CEP Panel working group starts work Oct 2018: Close of call for data on hazard assessment

Sep 2019: CEP Panel meeting• Toxicokinetic and physiologically based pharmacokinetic (PBPK) studies

published from 2013 till 2018 discussed• A draft summary of all studies has been revised

Current issues leading to a potential PIM updateBPA re-evaluation progress 2018-2020

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Issue

• “Bamboo” kitchenware = melamine plastic (main structural component) + bamboo (filler)• Marketed and advertised as bamboo• Enforcement revealed a migration of melamine and formaldehyde considerably above

SMLs of 2,5 mg/kg and 15 mg/kg, respectively

PIM Regulation applies to bamboo containing plastics FCM

June 2019 update

• Expert Working Group on FCM questioned whether bamboo falls under FCM No. 96 "wood flour and fibers, untreated“ (PIM)

• EFSA is requested for an updated risk assessment on FCM No. 96

Current issues leading to a potential PIM updateUse of bamboo in plastic FCMs

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Recycled Plastic Material Regulation (EC) No 282/2008

Materials and articles only from processes• assessed for safety by EFSA

• authorised by European Commission

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Ban on a single-use plastics (SUP) from 2021Directive (EU) 2019/904

Reference: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32017R0625

June 2019Directive (EU)

2019/904 on the reduction of the impact of certain plastic products

on the environment was

adopted

3 July 2021Restrictions on placing on the market (Art.5)

3 July 2024Product

requirements (caps and lids

to remain attached, Art.6)

31 Dec 2024Extended producer responsibility (Art.8)

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Ban on a single-use plastic from 2021Products to be banned

Reference: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32017R0625

Updates: Ceramics

Ceramics Potential update of Directive 84/500/EEC

• May 2019: Inception Impact Assessment published• Plan: to lower the limits of lead and cadmium and other metals to be released from

ceramic and vitreous FCMs• It also aims to align EU law on vitreous materials, i.e. on glass and enameled metals

Roadmap -> Feedback period (till 26.06.2019)->Public consultation->Draft act-> Commission adoption (2020)

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Updates: Enforcement

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May 2019

December 2019

Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

End of validity

Repealed byRegulation (EU) No 2017/625 on official controls and other official activities performed to ensure

the application of food and feed law, rules on animal health and welfare, plant health and plant protection products

Enforcement

• Coordinated control plan June-December 2019

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EnforcementOverview of control plan Recommendation No 2019/794Substance of concern Legal basis SMLs Products to be testedPrimary aromatic amines (PAA)

Annex II of Regulation (EU) No 10/2011

ND for the sum of PAA (<10 ppb)

Plastic tableware and kitchenware Printed food contact materials including paper and board

Formaldehyde FCM No 98 15 mg/kg (expressed as total formaldehyde and hexamethy-lenetetramine)

Plastic tableware and kitchenware including non-conventional plastic kitchenware and tableware

Melamine FCM No 239 2,5 mg/kg Plastic tableware and kitchenware including non-conventional plastic kitchenware and tableware

Phenol FCM No 241Commission Regulation (EU) 2015/174

3 mg/kg Plastic kitchenware and tableware;varnished or coated materials; printed plastic and paper and board packaging materials

Bisphenols including BPA and BPS

BPA FCM No 151Commission Regulation (EU) 2018/213 BPS ‘BPS’, FCM No 154

0,05 mg/kg Polycarbonate plastic (BPA) and polyethersulfone plastic (BPS); coated metal packaging (e.g. cans, lids)

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EnforcementOverview of control plan Recommendation No 2019/794Substance of concern

Legal basis SMLs Products to be tested

Phthalates and non-phthalate plasticizers

‘DBP’, FCM No 157 ‘BBP’, FCM No 159, ‘DEHP’, FCM No 283‘DINP’, FCM No 728‘DIDP’, FCM No 729

Epoxidized soybean oil (ESBO), FCM No 532‘DINCH’, FCM No 775‘DEHTP’ or ‘DOTP’, FCM No 798)

60 mg/kg(group restriction)

ESBO 30 mg/kg (children)

Plastic materials and articles (PVC) such as thermoformed sheets, flexible packaging and tubing; closures and lids.

Fluorinated compounds PFOA - Regulation (EU) 2017/1000 under REACH (Annex XVII)

Banned from 4 July 2020

Paper and board based materials and articles, including those used to wrap fast-food, takeaway and bakery products and microwave popcorn bags

Metals LeadCadmiumDirective 84/500/EEC (Ceramics)

Several SMLs depending on article type

Ceramic, enamel, vitreous and metal kitchenware and tableware including artisanal and traditionally produced materials and articles

Overall migration release of non-volatile constituents into food

60 mg/kg Non-conventional plastic kitchenware and tableware

Post BREXIT FCM legislation

March 2019● Post-Brexit legislation on the

safety of food contact materials: Statutory Instrument No.704 (2019)

● Part 2 amends subordinate legislation in England: Materials and Articles in Contact with Food (England) Regulations 2012

● Part 3 amends retained direct EU legislation for the whole of the United Kingdom

Reference: http://www.legislation.gov.uk/uksi/2019/704/schedules/made

Evaluation of FCM legislationRoadmap 2017-2020

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Purpose

• Assess whether the current EU legislative framework fit for purpose

• Examination of the situation concerning non-harmonized FCM

2019 activities

• Public consultation to ensure transparency and accountability

Short summary

● More PIM Regulation amendments in 2019 and 2020

● Ceramics Directive update in 2020

● Enforcement exercise results will be available in 2020

● FCM legislation evaluation by the EC to be completed in 2020

● A specific measure on printed FCM (harmonized) 2016 EC initiated work on a draft (initial timeline – end of 2018) Placed on hold – no certain deadline set

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Knoell NL B.V.The Netherlands

Ganna ZinchenkoGlobal Regulatory Affairs

– Industrial Chemicals

gzinchenko@knoell.comTel. +31 317 799 201

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