Update on Developments in Food Contact

Materials Legislation in the EU

Ganna Zinchenko, knoell NL
Waters Extractables and Leachables Forum
26 September 2019, Hamburg
 knoell global presence

UK NETHLERLANDS

GERMANY
FRANCE SWITZERLAND CHINA
PORTUGAL SPAIN
JAPAN USA
SOUTH KOREA

TAIWAN

THAILAND
BRAZIL

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China, Taiwan, Japan, KKDIK, Russia, Canada, Australia)
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transport classification)
● Medical devices
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Mercosur)
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● Cosmetics
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Agenda

General overview FCM legislation

in EU
Updates concerning Plastics and
Ceramics

Enforcement

Post-Brexit FCM legislation

Evaluation of FCM legislation

FCM legislation in EU: harmonzied
and non-harmonized
 EU FCM legislation
Framework
Reg (EC) 1935/2004 EU overview
GMP Member
Reg (EC) No 2023/2006 Paper and Board
States
PLASTICS
Reg (EU) No 10/2011 Glass
Adhesives

ACTIVE AND INTELLIGENT MATERIALS

Reg (EC) No 450/2009 Metals and alloys
Printing inks
RECYCLED PLASTIC MATERIAL
Reg (EC) No 282/2008
Material
Cork and wood
CERAMICS Ion exchange resins
Directive 84/500/EEC

REGENERATED CELLULOSE FILM Rubbers

Directive 2007/42/EC Varnishes and coatings

BPA in varnishes and coatings

Reg (EU) 2018/213 Waxes

EPOXY DERIVATIVES
Substance
Reg 1895/2005/EC
NITROSAMINES Switzerland
Directive 93/11/EEC
Printing inks
Products from China or Hong Kong
Reg (EU) No 284/2011 Origin
EU fundamental requirements for FCM

Regulation (EC) No
Framework Regulation
2023/2006 on Good
(EC) No 1935/2004
Manufacturing Practice
FCM must not:
- endanger human health GENERAL REQUIREMENTS
- bring an unacceptable change in composition of food - quality assurance
- bring a deterioration of organoleptic characteristics of - quality control
food
- documentation for FCM and articles

Authorization of substances is required for materials: SPECIFIC REQUIREMENTS

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
for 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 plastic
Requirements on labeling, traceability, DoC; active CEPI for paper and board
and intelligent materials EuPIA for (food packaging) printing inks

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 General approach to compliance of FCM
substances

National Positive/ Negative

Authorization
legislation lists No
No listing

Listed Not
Authorization with fulfilled
variation

Not
EU fulfilled Conservative • Functional barrier
• not detectable limit
legislation approach: lowest
• Functional barrier (<10ppb)
SML • No CMR
• not detectable limit
(<10ppb) • No nanoform
• No CMR
• No nanoform
NIAS
No Self-derived SML
Yes listing Worst case or SML TTC
calculation
Union list: SML OR
ND migration
N/A testing Risk
assessment
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Updates: Plastics
Plastic Materials Regulation (EU) No. 10/2011 (PIM)

Plastic materials based on synthetic polymers and/or chemically

modified natural polymers

Derogations:
Union list (authorized substances): May be present in articles:
PPA
Monomers or other starting substances Salts of NIAS
Additives excl. colorants authorized acids, Aids to polymerization
Polymer production aids (PPA) excl. solvents phenols or May be used in manufacture:
alcohols
Macromolecules obtained from microbial Colorants and solvents
fermentation Polymeric
additives

OML
SMLs Subject to safety
1069 10 mg/dm² Subject to
(mg/kg Restrictions (FWR Art.3) and
substances or 60 mg/kg national
food) risk assessment
food legislation
(PIM Art.19)

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PIM updates 2019
Amendments to Regulation (EU) No 10/2011
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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Current issues leading to a potential PIM update
BPA re-evaluation progress 2018-2020
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 US

Sep 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
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 Current issues leading to a potential PIM update
Use of bamboo in plastic FCMs
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

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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 2021
Directive (EU) 2019/904
June 2019
Directive (EU)
2019/904 on the 3 July 2024
reduction of the Product
impact of certain
plastic products requirements
on the (caps and lids
environment was to remain
adopted attached, Art.6)

3 July 2021 31 Dec 2024

Restrictions on Extended
placing on the producer
market (Art.5) responsibility
(Art.8)

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Reference: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32017R0625
Ban on a single-use plastic from 2021
Products to be banned

Reference: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32017R0625 16
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
 Enforcement

May 2019

• Coordinated control plan June-December 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 by
Regulation (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 20
Enforcement
Overview of control plan Recommendation No 2019/794
Substance of concern Legal basis SMLs Products to be tested
Primary aromatic amines Annex II of ND for the sum of PAA Plastic tableware and kitchenware
(PAA) Regulation (EU) No (<10 ppb) Printed food contact materials including paper
10/2011 and board

Formaldehyde FCM No 98 15 mg/kg (expressed Plastic tableware and kitchenware including

as total formaldehyde non-conventional plastic kitchenware and
and hexamethy- tableware
lenetetramine)
Melamine FCM No 239 2,5 mg/kg Plastic tableware and kitchenware including
non-conventional plastic kitchenware and
tableware

Phenol FCM No 241 3 mg/kg Plastic kitchenware and tableware;

Commission varnished or coated materials;
Regulation (EU) printed plastic and paper and board packaging
2015/174 materials
Bisphenols including BPA and BPA FCM No 151 0,05 mg/kg Polycarbonate plastic (BPA) and
BPS Commission polyethersulfone plastic (BPS); coated metal
Regulation (EU) packaging (e.g. cans, lids)
2018/213
BPS ‘BPS’, FCM No
154

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Enforcement
Overview of control plan Recommendation No 2019/794
Substance of Legal basis SMLs Products to be tested
concern
Phthalates and non- ‘DBP’, FCM No 157 60 mg/kg Plastic materials and articles (PVC) such as
phthalate plasticizers ‘BBP’, FCM No 159, (group restriction) thermoformed sheets, flexible packaging
‘DEHP’, FCM No 283 and tubing;
‘DINP’, FCM No 728 ESBO 30 mg/kg closures and lids.
‘DIDP’, FCM No 729 (children)

Epoxidized soybean oil (ESBO), FCM

No 532
‘DINCH’, FCM No 775
‘DEHTP’ or ‘DOTP’, FCM No 798)
Fluorinated compounds PFOA - Regulation (EU) 2017/1000 Banned from 4 July Paper and board based materials and
under REACH (Annex XVII) 2020 articles, including those used to wrap fast-
food, takeaway and bakery products and
microwave popcorn bags

Metals Lead Several SMLs Ceramic, enamel, vitreous and metal

Cadmium depending on kitchenware and tableware including
Directive 84/500/EEC (Ceramics) article type artisanal and traditionally produced
materials and articles

Overall migration release of non-volatile constituents 60 mg/kg Non-conventional plastic kitchenware

into food and tableware

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 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 legislation
Roadmap 2017-2020

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

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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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Contact us

Knoell NL B.V.
The Netherlands

Ganna Zinchenko
Global Regulatory Affairs
– Industrial Chemicals

gzinchenko@knoell.com
Tel. +31 317 799 201

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