Agoria Food Contact Materials seminar Plasticsagoria.be/RNevent/presentations/Presentatie...

Agoria Food Contact Materials seminar – Plastics

15/10/2015

Erik Hendriks, adviser packaging, Federplast.be [email protected]

&

Geoffroy Tillieux, Director of the technical department, EuPC [email protected]

A collaboration between

EuPC, Federplast.be and PCE

mailto:[email protected]


FEDERPLAST.BE Association des Producteurs d’Articles

en Matières Plastiques et Elastomères Une structure coupole commune de Agoria et essenscia

EuPC is the EU-level Trade Association,

based in Brussels,

representing European Plastics Converters

Polymer Comply Europe (PCE) is a service

provider for the plastics industry specialised

in EU legislation

Table of Content

1. Europe

2. Belgium

1. AR Arreté Royal

2. Autocontrole

3. Assessments

4. Exposure Tools

1. MATRIX,

2. Case Study

3. FACET

5. Brainstroming on future regulation

6. Recycled Plastics

7. FREP

Europe

1. Europe

European legilsative overview

Framework Regulation (EC) No

1935/2004

GMP Regulation (EC) No

2023/2006

Paper & Board

(DE, NL,IT, FR,

CH)

Coatings

(DE, NL,IT,

ES, BE)

Adhesives

(DE, ES,IT)

Ion exchange

Resins

(ES)

Printing inks

(CH,

upcoming DE)

Rubbers

(NL,DE,ES,

FR)

Glass, Wood, Cork, Textile, Metal,

Silicones, Waxes

Mem

be

r

Sta

tes

Regenerated

Cellulose

2007/42/EC

Ceramics

84/500/E

EC

Plastics Regulation

(EU) No 10/2011

(PIM) Dir. 93/11/EC

Nitrosamines

A & I

materials

(EC)450/2009

Recycled Plastics

282/2008

Reg.1895/2005

BADGE/NOGE

Substance specific Measures

Eu

rop

ean

Co

mm

issio

n

Materials specific Measures

http://www.google.nl/url?url=http://www.logo00.com/logo-union-europeenne/&rct=j&frm=1&q=&esrc=s&sa=U&ei=1zIYVOzxEYWTyATRyoLICA&ved=0CBYQ9QEwAA&usg=AFQjCNEGLhY853b5Krj26pELgkCeNTUdHQ

1. Europe


Framework regulation Art. 1 : Scope

• Food contact materials and articles: • Materials and articles which in their finished state are

intended to be brought into contact with food (ie; cutlery, containers, Materials and articles in contact with water for human consumption) OR

• Materials and articles already in contact with food and were intended for that purpose (ie; food packaging) OR

• Materials and articles that 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 (ie; food processing machinery, napkins….)

Framework regulation Art. 1 : Out of Scope

• The Regulation does not apply to:

• materials and articles which are supplied as antiques;

• covering or coating materials, such as the materials

covering cheese rinds, prepared meat products or fruits,

which form part of the food and may be consumed

together with this food

• fixed public or private water supply equipment (therefore

e.g. drinking water fixed infrastructure regulated by a

separate legislation)

1. Europe


EC No. 1935/2004 Art. 2 :Important

definitions

• Traceability: the ability to trace and follow a material or

article through all stages of manufacture, processing and

distribution;

• Placing on the market: the holding of materials and articles

for the purpose of sale, including offering for sale or any

other form of transfer, whether free of charge or not, and

the sale, distribution and other forms of transfer themselve

• Other definitions : active & intelligent materials and articles,

business operators

1. Europe


Framework regulation Art. 3 :General Safety

Requirements

• Materials and articles must be manufactured in compliance

with GMP so that, under normal or foreseeable conditions

of use, they do not transfer their constituents to food in

quantities which could:

• endanger human health;

• bring about an unacceptable change in the composition of the

food;

• deteriorate the organoleptic characteristics of food

• Labelling or advertizing must not mislead consumers

1. Europe


Framework regulation

Art. 3 is the cornerstone of the whole food contact

legislation

• Basis for the general obligation of safety

• Basis for GMP regulation

• Basis for concept underlying supporting documentation and

declaration for conformity

• Basis for migration based legislation

• Basis for an exposure based approach in defining safety

• Defines rules of behavior in the information of consumers

1. Europe


Framework Regulation

The Regulation establishes 17 groups of materials and articles which may be covered by specific measures (annex 1)

Article 5 is the basis for specific measures for those groupes of materials

Until now focus almost exclusively on plastics

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

1. Europe


Framework regulation

Authorisation (art. 9 to 12) • Required for

• substances used in FCM (plastics, A+I, cellulose films)

• materials and articles

• Manufacturing processes, specifically chemical recycling of FCM plastics

• Application submitted to member state

• Evaluated by European Food Safety Authority (EFSA)

• Standing Committee on the Food Chain and Animal Health (European Commission) gives opinion

• Final approval when listed in legislation

• Authorization may be suspended or revoked at the initiative of EC or Member States

• Authorization may be modified at the initiative of the authorization holder or Authorities

1. Europe


Traceability: • Traceability must be achieved at all stages of

manufacturing, processing and distribution

• Business operators shall have in place systems to identify the materials and articles supplied to them, and to whom they have supplied their finished products. Importers are responsible for imported products.

• Info shall be supplied to the competent authorities on demand.

• Traceability shall be achieved by labelling or by other identification systems, e.g. documentation.

• Packaging chain guidande available (2004)

1. Europe


Declaration of Compliance and Supporting Documentation (Article 16) • All materials addressed via specific measures under Art.5

must be accompained, at the moment of sale, by a “document” that ensures that they comply with the rules applicable to them;

• Declaration of Compliance

• The manufacturers af the said materials shall maintain records of all elements (documentation, tests, calculation) used for releasing the Declaration of Compliance, that may be inspected by the relevant Authorities.

• Supporting Documentation

1. Europe


GMP (EC No. 2023/2006)

• Materials and articles must be manufactured in accordance

with Good Manufacturing Practices

• For all FCM and all stages of production

• General requirements for establishing QA and QC and

documentation

• Provides specific rules for printing inks on non-food contact side (no

transfer)

• Specific plastics industry GMP guidelines already established years

ago

1. Europe


1. Europe


10/2011 and its amendments

Scope (art. 2 & 3):

• Printed or coated plastic materials and articles;

• Printed or coated plastic multi-layer materials and articles

held together by adhesives or other;

• Plastic layers or coatings forming gaskets in caps and

closures that make a set of 2 or more layers of different

types of materials;

• Plastic layers in multi-material, multi-layer materials and

articles;

1. Europe



Scope (art. 2 & 3):

• Inks, coatings and adhesives components partially covered

by legislation;

• Epoxy resins functioning as main structural component of

plastics article

• Are excluded

• Ion exchange resins;

• Rubber;

• Silicones

1. Europe



• Positive list (or Union list) (979 substances)

• Migration (global and specific)

• Migration tests and conditions (simulant type, time, T°- standardisation)

• Article 19 – risk assessment of NLS (Non Listed Substances), and

NIAS (Not Intentionnally Added Substances)

1. Europe



• Union List : Art. 5.2 sets up a positive list system. Only those substance

listed in the list may be intentionally used in the manufacture of plastic

layers in plastic materials and articles

• Which substances/mixtures?

• Monomers or other starting substances;

• Additives excluding colourants

• Polymer production aids excluding solvents (please note that list not fully

positive for this category as National lists allowed as well)

• Macromolecules obtained from microbial fermentation


Union List :

• Substances regulated at National Level • Polymer production aids not mentioned in the positive list

• Colourants and solvents

• Substances not included but authorised

• Specific salts of authorised acids, phenols or alcohols

• Mixtures obtained by mixing authorised substances without a chemical reaction of the components

• Plastics when used as an additive

• Prepolymers and natural or synthetic macromolecular substances, as well as their mixtures, when used as monomers

• Non-intentionally added substances (NIAS)

• Aids to polymerisation

• Subject to safety requirements

1. Europe



Some materials covered in scope with transition period

• Some glass fibre sizings

• Additives other than plasticizer in plastics layer or plastics coatings of

caps & closures

• Transition period until 31/12/2015 (in between petition must have been

introduced and approved if not already done)

1. Europe


Requirements applicable to components

Substance In EU

list

Not

in EU

list

Apply EU

list limits

Apply

National or

other EU

law

Apply lowest

limit

Self

responsibility

(art. 3

framework)

Monomers, additives & macromolecules

from microbial fermentation

v v v

Components of inks, adhesives & coatings

on plastic substrate (art. 2.3 & recital 6)

(case 1)

v v v v v

Components of inks, adhesives & coatings

on plastic substrate (art 2.3 & recital 6)

(case 2)

v v v

PPAs (art. 6.1)

(case 1)

v v v

PPAs (art 6.1)

(case 2)

v v v

Colorants and solvents (art. 6.2) v v v

Salts, mixtures w/o chem reaction,

polymeric additives and starting substances

(art 6.3)

v See art.

6.3 and 8

to12

v

Non intentionnally added substance and

aids to polimerization (art 6.4)

v

1. Europe



• Overall migration : migration of all the components of the food contact

material through the food, the material should be the most inert as

possible, OML: 10 mg/dm² or 60 mg/kg of food.

• Specific migration: migration of a specific component of the food

contact material through the food : SML to be found in table 1 annex 1

of 10/2011

Migration Testing • For food not already in contact with food, the food simulants

corresponding to a certain type of food in table 2 annex III apply

• Annex V defines how compliance testing should be done

1. Europe


Specific Migration Testing: Annex V • For materials already in contact with food : Chapter 1

• For materials not yet in contact with food : chapter 2, the

conditions of time and temperature are set out in table 1

and table 2

• The sample shall be placed in contact with the food

simulant in a manner representing the worst of the

foreseeable conditions.

• The analyse of the migrating substances shall be done in

accordance with regulation 882/2004

1. Europe


Overall Migration Testing: standardized testing

methods set out in Annex V chapter 3

1. Europe


Migration Testing:

Correction factors applies when comparing

migration test results with migration limits: • Correction of specific migration in foods containing

more than 20 % fat by the Fat Reduction Factor (FRF

= % fat*5/100)

• Correction of migration into food simulant D2

• Correction of both factor when both conditions are met

(by multiplying both factor, but never exceeding 5)

1. Europe


Transition between old and new legislation

• As of 1 January 2013 10/2011 will replace rules for

migration testing and simulants for migration testing:

A transition period until 2015 was foreseen for

supporting documentation

1. Europe


Other important features • Functional barrier

• ‘A barrier consisting of one or more layers of any material which ensures that the final material or article complies with Art. 3 of Regulation (EC) No. 1935/2004 (not CMR, not nano, not detectable 10ppb)

• Nanomaterials • Autorisation before use

• Included but not defined, just refers to ‘substances in nanoform’

• Article 15 prescribes the drafting of a declaration that will be supported

by supporting documentation (art.16). The outline is foreseen in annex

IV

1. Europe


• Assessment of substances not included in the Union list (NLS and

NIAS) (Art. 19): substances which are not covered by an inclusion in

Annex I to this Regulation shall be assessed in accordance with

internationally recognised scientific principles on risk assessment

1. Europe


• 6th ammendment in preparation (draft – susceptible to change)

• Main potential modifications: • Plastic materials and articles shall not release the following substances in quantities exceeding the specific

migration limits below:

• Aluminium = 1 mg/kg food or food simulant.

• Barium = 1 mg/kg food or food simulant.

• Cobalt = 0,05 mg/kg food or food simulant.

• Copper = 5 mg/kg food or food simulant.

• Iron = 48 mg/kg food or food simulant.

• Lithium = 0,6 mg/kg food or food simulant.

• Manganese = 0,6 mg/kg food or food simulant.

• Nickel = 0,02 mg/kg food or simulant.

• Zinc = 5 mg/kg food or food simulant

Those new updates or limits are set as safety factor, the industry commented that there is some

confusion as there are limits for different types of materials (plastics, metals,…) a different approach is

needed for metals and that the source of those metals can be diverse (e.g. coating)

• Update in the table 1 Annex I (‘union list’), table 2 annex II, table 2 annex II and table 3 annex V

• Restriction on oligomers

1. Europe


Belgique

Législation applicable:

• 1935/2004 (direction cadre)

• 2023/2006 (GMP)

• Arrêté Royal du 2 juin 2015 modifiant l’arrêté royal du 11 mai 1992 relatif aux

matériaux et aux objets destinés à entrer en contact avec les denrées

alimentaires

• Arrêté royal du 10 février 2011 modifiant l'arrêté royal du 3 juillet 2005 relatif

aux matériaux et aux objets en matière plastique destinés à entrer en contact

avec les denrées alimentaires

• 4 septembre 2012. - Loi modifiant la loi du 24 janvier 1977 relative à la

protection de la santé des consommateurs en ce qui concerne les denrées

alimentaires et les autres produits, visant à interdire le bisphénol A dans les

contenants de denrées alimentaires • est applicable à tous les matériaux et objets destinés à entrer en contact avec des denrées

alimentaires pour enfants de 0 à 3 ans

2. Belgique

Législation

Législation applicable:

• Arrêté Royal du 16 janvier 2006 fixant les modalités des agréments, des

autorisations et des enregistrements préalables délivrés par l'Agence fédérale

pour la Sécurité de la Chaîne alimentaire (AFSCA) • il est stipulé que les fabricants, les importateurs et les grossistes de conditionnement doivent être

enregistrés.

• AR 11/2003 Arrêté royal relatif à l’autocontrôle, à la notification obligatoire et à la

traçabilité dans la chaîne alimentaire

2. Belgique

Législation

2. Belgique

Déclaration de conformité :

Déclaration de conformité :

• tous ces matériaux et objets doivent toujours être accompagnés d’une déclaration écrite

attestant qu’ils répondent aux conditions imposées, appelée «déclaration de conformité»

(DC),

• Le DC doit être établie par le responsable des matériaux et des objets. Cela peut être à

la fois le fabricant, l’importateur ou le commerçant,

• une DC peut rester valable pour une période maximale de 5 ans,

• les fabricants, les importateurs, les transformateurs et les vendeurs de matériaux et

objets destinés à entrer en contact avec les aliments, mais qui ne sont pas encore en

contact avec les aliments doivent fournir une déclaration,

• cette DC qui doit accompagner le FCM tout au long de la chaîne d'approvisionnement,

ainsi que les pièces justificatives nécessaires, qui démontrent que le produit est

conforme, peut être soumis à l’AFSCA. Cette documentation peut contenir les conditions

et les résultats des analyses ou des calculs et autres analyses, et des preuves sur la

sécurité ou les arguments que les exigences sont remplies,

• cette DC peut être sous format papier ou numérique.

• La déclaration de conformité est rédigée dans l’une des trois langues nationales ou

éventuellement en anglais.

Déclaration de conformité : • Les autorités belges du Service Public Fédéral (SPF) Santé publique, Sécurité de la Chaîne alimentaire et

Environnement et de l’Agence fédérale pour la Sécurité de la Chaîne alimentaire (AFSCA) ont fixé, une liste de points

minimum qui doivent obligatoirement figurer sur la déclaration de conformité :

• 1. nom et adresse du fabricant/de l’importateur dans l’UE;

• 2. nom du produit;

• 3. identité des matériaux/articles;

• 4. date de déclaration;

• 5. confirmation que les matériaux/les articles sont conformes aux exigences de la législation UE, et si d’application, à celles de la

législation belge dans les conditions d’utilisation; p.e. je soussigné (responsable de la compagnie) déclare que le matériel/objet

est conforme …

• 6. En l’absence de réglementations belges ou européennes des informations pertinentes (normes, valeurs guides, restrictions

interntionales) doivent être fournies pour chacune des substances pour lesquelles des spécifications existent.

• 7. Si d'application, mentionner les conditions d'utilisation suivantes : (Les points "pertinents" doivent y figurer) − type de denrée

alimentaire entrant en contact avec le matériel ou objet visé − temps de conservation et température du matériel/objet − éventuel

traitement du matériel/objet − rapport surface/volume.

Ces points doivent obligatoirement être mentionnés sur la déclaration de conformité pour tous les matériaux et objets

destinés à entrer en contact avec des denrées alimentaires ; quel que soit le type de matériaux dont ils sont faits (ex.

plastique, métal, peinture, carton, papier, etc…) sauf pour les objets et les matériaux pour lesquels des règles spécifiques

existent en ce qui concerne la déclaration de conformité.

=> Pour les matières plastiques il faut référer à la réglementation 10/2011 annex IV

2. Belgique 2.Déclaration de conformité et étiquetage:

Déclaration de conformité : Pour les matières plastiques il faut référer à la réglementation 10/2011 annex IV

ANNEX IV

Declaration of compliance

The written declaration referred to in Article 15 shall contain the following information:

(1) the identity and address of the business operator issuing the declaration of compliance;

(2) the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from

intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;

(3) the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the

manufacturing of those materials and articles;

(4) the date of the declaration;

(5) confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet

relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004;

(6) adequate information relative to the substances used or products of degradation thereof for which restrictions and/or

specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance

with those restrictions;

(7) adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or

theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives

2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or,

in their absence, with national provisions applicable to food;

(8) specifications on the use of the material or article, such as:

(i) type or types of food with which it is intended to be put in contact;

(ii) time and temperature of treatment and storage in contact with the food;

(iii) ratio of food contact surface area to volume used to establish the compliance of the material or article;

(9) when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the

requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation

2. Belgique 2.Déclaration de conformité et étiquetage:

2. Belgique

Déclaration de conformité et étiquetage :

Étiquetage :

Les mentions suivantes sont obligatoires :

• une indication de l’aptitude au contact avec les denrées alimentaires ;

• si nécessaire, des instructions spéciales pour une utilisation sûre et adéquate ;

• nom/dénomination commerciale et adresse ou siège social d’un fabricant/transformateur, ou d’un

vendeur dans l’UE qui est responsable de la commercialisation du produit ;

• données garantissant la traçabilité aussi bien en amont qu’en aval;

• mention spéciale en cas de matériaux/objets actifs.

• Le règlement 1935/2004 stipule que la traçabilité des matériaux

et objets doit être garantie à tous les stades afin de faciliter les

contrôles, le retraits des produits défectueux, d’informer les

consommateurs ainsi que la détermination des responsabilités

2. Belgique

Traçabilité

• Le règlement 2023/2006 (GMP) relatif aux bonnes pratiques de

fabrication des matériaux et objets destinés à entrer en contact avec

des denrées alimentaires est d’application

• Ce règlement prévoit que tout doit être mis en oeuvre afin de prévenir

toute contamination, qu’un système d’assurance qualité doit être mis

en oeuvre

2. Belgique

Bonne pratiques de fabrication

• Arrêté Royal du 16 janvier 2006 fixant les modalités des agréments, des

autorisations et des enregistrements préalables délivrés par l'Agence fédérale

pour la Sécurité de la Chaîne alimentaire (AFSCA) • il est stipulé que les fabricants, les importateurs et les grossistes de conditionnement doivent être

enregistrés.

2. Belgique

Enregistrement

2. Belgique

Autocontrole

• Obligations pour les transformateurs de matières plastiques (mais pas

uniquement): • l’instauration d’un système d’autocontrôle est obligatoire pour les opérateurs soumis à

l’enregistrement

• AR 11/2003 Arrêté royal relatif à l’autocontrôle, à la notification obligatoire et à la

traçabilité dans la chaîne alimentaire • Art.1 §12° Autocontrôle : l’ensemble de mesures prises par les exploitants pour faire en sorte que les

produits à toutes les étapes de la production, de la transformation et de la distribution et dont ils ont en

charge la gestion :

• répondent aux prescriptions réglementaires relatives à la sécurité alimentaire;

• répondent aux prescriptions réglementaires relatives à la qualité des produits, pour lesquelles

l’Agence est compétente;

• épondent aux prescriptions du chapitre 3 sur la traçabilité et la surveillance du respect effectif de ces

prescriptions;

• Art.1 § 13° Traçabilité : la capacité de retracer le cheminement d’un produit, à travers toutes les étapes de

la production, de la transformation et de la distribution;

• Les producteurs d’emballages primaires alimentaires doivent s’enregistrer auprès de

l’AFSCA

2. Belgique

Autocontrole

• Les différents secteurs représentants les producteurs d’emballages

alimentaire travaillent à l’élaboration d’un guide d’autocontrôle,

permettant à l’AFSCA ou à des tiers certifiés de faire des audits et

contrôles auprès de l’industrie,

Assessment

Risk

Assessment

Consumer

Safety

=

Hazard

Characterization

Toxicological

Data

x

Exposure

Quantification

Consumer

Contact Data

3. Assessment

4 elements of risk assessment

1. Hazard Identification

2. Hazard characterization

3. Exposure assessment

4. Risk characterization

3. Assessment

Two types of Non listed substances

1. Intentionally added substances (e.g. ink, coating…).

• Those have been assessed by the supplier under art 3. It is

important to follow prescribed conditions of use. In case those

subtance migrate into food an exchange of information may be

needed if this behaviour has not been foreseen and

communicated by supplier

2. Not Intentionally added substances (reaction and

degradation products, impurities…)

1. Migration into food evaluation

(Worst case) calculation, if not sufficient e.g.

experimental testing

2. Toxicology assessment of migrants regarding

potential CMR criteria and

3. Derive where applicable Tolerable Daily Intake

threshold

4. Verify restrictions set by Authorities e.g. Primary

Aromatic Amines

5. Conclude on tolerable migration into food

6. File Risk Assessment as Supporting Document

3. Assessment

Risk Assessment of a substance - Steps

3. Assessment

Exposure

• Use of Exposure in risk Assessment is rather woolly in the

Regulation;

• Acceptance is uncertain, especially by Member States

• Use of Exposure by EFSA only limited to new substances’

applications; nothing said on finished FCM, which

nevertheless are tied by law to show compliance with Art. 3

of the framework Regulation;

3. Assessment

Risk Assessment’s interpretation

• Labs focusing on analytical approach, i.e. Hazard Identification

• There is a potential for in-silico tox evaluation (QSAR), possible

though not entirely developed yet.

• Some promote in-vitro tox tests

• The very basic meaning of Risk Assessment often not fully

understood or overlooked

• Many interpretations equal to no interpretation

Exposure Tools

Advanced Exposure Tools

• In the past 10 years more refined exposure tools were developed. They allow a

differentiation from the „standard“ assumption of 1 kg food being packed in 6 dm².

MATRIX (Plastics Value Chain) – Plastic FCM

FACET (EU Framework Program) – all FCM

• They consider actual food consumption data (diatary surveys) and packaging material use.

What is the Matrix calculation tool ? https://matrixcalculation.eu/

https://matrixcalculation.eu/

What is the Matrix calculation tool ?

The Matrix calculation tool is a tool for the assessment of NIAS (Non Intensionnally

Added Substances) based on exposure data.

There is a need for a practical approach to enable risk management decided in a tiered way

We cannot make toxicological test for all the NIAS,

We need to fix a level of migration above which every migrant should be known and

assessed but under which the corresponding exposure is admitted trivial enough to avoid

further assessment,


This level, LOI (Level Of Interest), linked to each packaging material, will be function of

the exposure of consumers to this material,

The exposure to any substance migrating from this surface is:

Exposure [ µg/person/day] = Migration [µg/dm²] x S (surface of exposure)

[dm²/person/day]

Then a Level Of Interest (LOI) can be calculated :

With as Tolerable Exposure Level (TEL) for NIAS defined at 10

μg/person/day

The surfaces to which the consumers are exposed are

obtained by combining through probabilistic modeling the

weights of each food ingested by a population with the

surfaces of packaging materials in contact with the unit

weight of these respective foods

TEL

------

S

=

max. migration tolerable or LOI for this

material and this consumer



The dietary data and the packaging data have been gathered in the 5 next countries

(France, Germany, Italy, Spain and United Kingdom) to represent the European mean

values.

Those data have been gather via official dietary survey of each of those countries as

BFR for Germany and Euromonitor (and GVM for Germany) for the packaging data.

51 food classes and 77 packaging materials have been fixed

Those data are entered in a cross table the crossing give the surface exposure for the

type of packaging and the type of food.

Packaging consumption with

direct food contact in

Germany -

relevant parameter:

packaging surface 2003, packaging < = 6,5 kg nominal

contents

by material types

differentiated after main

components and side

components

packaging

surface

1.000 m²no

n-ex

pand

ed P

S

EP

S

soft

PV

C a

nd P

VD

C

rigi

d P

VC

and

PV

DC

othe

r m

ono-

plas

tics

AP

ET/

PE

plas

tic/A

PE

T/P

E

OP

ET/

PE

plas

tic/O

PE

T/P

E

met

alliz

ed-O

PE

T/P

E

plas

tic/m

etal

lized

-OP

ET/

PE

PV

C/P

E

plas

tic/P

VC

/PE

PA

/PE

plas

tic/P

A/P

E

OP

A/P

E

plas

tic/O

PA

/PE

met

alliz

ed-O

PA

/PE

plas

tic/m

etal

lized

-OP

A/P

E

OP

P/P

E

f illing groups total

1. alcoholic beverages

including wines, beers and

liquors 16.407 0 0 0 0 0 0 0 189 0 353 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

main component 16.319 0 0 0 0 0 0 0 189 0 353 0 0 0 0 0 0 0 0 0 0

closures or other side components 89 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

2. non-alcoholic non-dairy

beverages including waters,

juices and soft drinks 966.830 1.827 0 0 0 0 0 0 0 0 1.326 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

main component 957.107 1.827 0 0 0 0 0 0 0 0 1.326 0 0 0 0 0 0 0 0 0 0

closures or other side components 9.724 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

3. concentrates of juices

and soft drinks; syrups for

dilution 793 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

main component 769 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0


4. liquid coffee or tea

preparations 158 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

main component 151 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0


5. dry coffee, tea, cocoa

powder, dry beverage powders 166.226 190 0 0 0 0 0 0 1.905 10 35.813 1.115 0 0 113 0 244 0 207 13 0

0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

main component 151.596 0 0 0 0 0 0 0 1.905 10 35.813 1.115 0 0 113 0 244 0 207 13 0

closures or other side components 14.630 190 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0


An extract from the GVM (Germany) data base: packaging surfaces

It is based on the values extract in the cross tables that Matrix

and the type of food consume per day that we get the S factor

Matrix : case study

Matrix : case study

Steps to do a full risk assessment on a food contact material (packaging) :

1. Run a migration test / analysis

2. Obtain a forest of peaks

3. Determine a LOI (with MATRIX calculation tool)

4. Identify the substances in presence above the determined LOI

5. Identify the substances in positive list

6. Risk assess the substances present in a concentration above the LOI: do a toxicological evaluation of those substances

7. Based on this evaluation determine a new LOI (based on the TTC)

8. Verify if substances are still present above the new LOI

9. Other approaches ?

Identify in the forests of peaks

MATRIX : case study

Identify of the peaks

Chromatogram of the

internal surface analysis

1. Determination of the Level Of Interest

(LOI):

1. Identify the countries, type of food

(simulant) and the type of packaging

2. Calculate (the LOI = TEL/Surfof exp;

default* TEL is 10µg/pers&day)

3. In our example the LOImin is 4,45

µg/dm² and the LOImax is 14,86

µg/dm²

MATRIX : case study

determine of the LOI

In our case :

Countries : all the 5 countries

Type of food : all simulants

Type of packaging : OPP

* As 10 μg/kg of food is considered by the food contact legislation as the threshold of detection on

the basis of which it can be decided whether a functional barrier is present

In our case study we have an OPP

packaging

Identify in the forests of peaks which peaks are above the LOI

MATRIX : case study

Identify the peaks above the LOI

Any peak above the LOI (4,45 µg/dm²

for the worst case scenario) should be

risk assessed, the peaks under the LOI

are exempted (no risk under that

level), excepted for the listed

substances

Identify the substances in positive list

• BHT (#315) : has an SML : 3 mg/kg, conc : 45 µg/dm² => 45x6

µg/kg* => 0,27 mg/kg => < SML => OK

• Sebacic acid dibutylester (#242) & tributyl acetyl citrate (#138),

group SML (32) : 60 mg/kg => 84 + 145 µg/dm² = 229 µg/dm² =>

229x6 µg/kg = 1,374 mg/kg <60 mg/kg => OK

• Erucamide (#271) : has no SML (permitted additive to adhesives

used in food packaging) => max allowed migration: 60 mg/kg (art

11.2 of 10/2011) =>15µg/dm² => 0,09 mg/kg => ok

*The factor ‘6’ comes from the conversion factor of 1kg/6dm²packaging

x µg/dm² => 10-3X mg/dm².6dm²/kg => 6.10-3Xmg/kg

Condition of article 17 of 10/2011

Identification of the substances to further assess:

• Cyclohexadecane (CAS 295-65-8),

• 7,9-di-tert-butyl-1-oxaspiro(4,5)deca-6,9-diene-2,8-dione need

to be further assessed

After identification of the peaks of the substances in a

concentration above the LOI a toxicological evaluation of

those substances is needed :

• how to assess the evaluation of those substances :

• Get information on the specific substance

• QSAR method (Quantitative Structure Activity

Relationships – tool that modelises and predicts (in

different hazard categories) the toxicity of a substance

based on its structure)

After the risk assessment : the toxicological

evaluation

Cyclohexadecane (CAS 295-65-8)

Cyclohexadecane (CAS 295-65-8) :

substance identified as a Cramer class I (chemicals of simple structure, with efficient modes of

metabolism, suggesting low oral toxicity)

=> TTC of 1800 µg/pers.day can be reintroduced as new TEL

Verification if in this case the concentration is still above the LOI

The recalculation gives a LOImin of 100 µg/dm²

We are save in our case as we have a concentration of 11 µg/dm² =>

no further assessment is needed

Ref : Opinion on Threshold of Toxicological Concern, EFSA Journal 2012

7,9-di-tert-butyl-1-oxaspiro(4,5)deca-6,9-diene-2,8-

dione

7,9-di-tert-butyl-1-oxaspiro(4,5)deca-6,9-diene-2,8-dione,

• CAS Number: 82304-66-3

• Molecular Formula: C17H24O3

• Molecular weight: 276.3707

• Structural Formula:


dione : assessment

• It is identified as a Cramer class III (Substances with chemical structures that permit no strong initial presumption of safety or may even suggest significant toxicity or have reactive functional groups)

• A Cramer class III substance has a TTC of 90 µg/person.day

• 90 µg/person.day can be reintroduce as new TEL in Matrix

• Verification if in this case the concentration is still above the LOI

• The recalculation gives a LOImin of 40 µg/dm²

• We are save in our case as we have a concentration of 13 µg/dm² => no further assessment is needed

Ref : Opinion on Threshold of Toxicological Concern, EFSA Journal 2012

Other approach ?

Cyclohexadecane

But :

As the TTC is based for one specific food stuff and

that the Matrix tool is based on the diet there might

be some incertitude,

For this reason next approach was presented in a

PhD thesis*, this approach can be discussed here

and might be fine tuned

Calculation of the exposure:

25 µg/pers.day

*Serena Stracuzzi, Safety evaluation of commercial flexible packaging materials via

exposure assessment of Non-listed and Non-Intentionally Added Substances.

University of Modena and Reggio Emilia.

Cyclohexadecane

Based on the Cramer class and the exposure we can cross check in this table.

Based on this we have get a ‘2’ (Cramer class I and exposure of 10<x<30 µg/pers.day: calculated via

Matrix tool) => tolerable => needs no further assessment:

Other approach ?


dione : assessment

Calculation of the exposure:

30 µg/pers.day


dione : assessment

Based on the Cramer class and the exposure we can cross check in this table.

Based on this we have get a ‘4’ (Cramer class III and exposure of 30 µg/pers.day: calculated via Matrix tool) =>

moderate => needs further assessment:

We want to get to a moderate => get a ‘2’ => our exposure should be less than 10 µg/pers.day => the original TEL


dione : assessment

It means we need to assess this substance further.

We should discuss with our supplier :

He can tell that it is a decomposition product of IRGANOX 1076.

IRGANOX 1076 is a phenolic antioxidant, stabilizer for organic substrates such as plastics, synthetic fibers,

elastomers, adhesives, waxes, oils and fats.

We can further assess to know how harmful this substance can be or compare it to another material

FACET

• What is FACET ?

Who does what? How efforts may be

mutually helping?

• Boundaries of responsibility very unclear

• Strong sense of uncertainty spread along the whole FCM chain: the law call

for stiffer control, while remaining strikingly silent on who it expects to be

responsible for what;

• Guidance on «Exchange of information» not helping: focuses just on giving

information to the next in the chain

Mixing-up plastics and non-plastics

issues

• Given the standing framework, mixing-up issues

can only be scaremongering:

• I have an issue with non-plastics

• As they are less or no regulated, I call for tightening of

the plastic regulation because, or in the hope, that

plastics regulations are used by reference for non-plastic

materials

Brainstorming on future of

food contact material

regulation

Plastics Packaging is strongly regulated

Plastics amongst the very

few materials with

harmonized EU legislation

Plastics are the most regulated amongst Food Contact Materials

To facilitate the application of the changes in the

regulation over time, Plastic Coordination Group in

the EU try to provide answers, using innovative

principles:

• E.g. The plastic value chain represented by EUPC,

FPE, CEFIC FCA and Plastics Europe lead the effort

to develop the exposure matrix project to help the

companies to deal with the exposure of NIAS and NLS

(2005-2011).

• Web-based software has been developped (Jan

2015)

• Access: https://matrixcalculation.eu/

• The outcome report can be used as supporting

documentation.

https://matrixcalculation.eu/

Future FCM Legislation Should

79

• Ensure negligible risk from FCM

• Apply equally to imported materials (and packed foods)

• Be enforceable

• Increase public confidence in safety of packed food

• Not be a barrier to innovation – mechanisms should cope with new materials and substances

• Be cost effective for the value chain as a whole

•The manufacturer of a component is responsible for its compliance

•Transfer of all information needed to demonstrate compliance

• Be capable of introduction within a reasonable time frame – years rather than decades

Key Points

80

Harmonization: EU measure

Inclusive: Cover all food contact substances

Risk evaluation: EFSA assessed / non-EFSA assessed

Risk assessment based on exposure

recycled plastic materials and

articles intended to come into

contact with foods

Regulation 282/2008

Regulation 282/2008

• Art. 2 : scope only mechanical recycling processes

• Art 3 : recycled plastics materials may only be put on the

market if

• Produced by an authorized recycling process

• Under GMP

• Article 3 not yet in force

• Art. 10 : audits shall berify that the recycling process

correpsonds to authorized process

• Art13,14 organizes transition – initial authorization phase

Not yet finished, but final phase

6. Recycled plastic materials

Authorization when and how?

• Authorization decisions should be issued early 2016?

• 2 parts :

• Confidential part (parameters of critical steps if claimed, critical

parameters)

• Public part (what is in opinion, main step of process, anything related to

safety)

• Which processes? Would in principle both include processes

submited in the early application period and those processes

analyzed until now (EFSA opinion)

• Authorization is an asset of the company. It must be sold

separately from the recycling equipment itself



Guidance & Auditing

• Guidance for auditors under development by EC

• Elaborated in TF

• EC

• Member States

• Industry (including EuPC, PRE)

• Entry point for auditor : the Compliance Monitoring

Summary sheet

• 2-4 pages

• Identifies technology, control variables and validation rules

• Template to be defined in regulation


Management system for audit


CMSS

• Guidance for auditors under development by EC

• Elaborated in TF

• EC

• Member States

• Industry (including EuPC, PRE)

• Entry point for auditor : the Compliance Monitoring

Summary sheet

• 2-4 pages

• Identifies technology, control variables and validation rules

• Template to be defined in regulation


FREP: Food contact Regulatory Experts

Panel

FREP :

FREP was created in 2010 to have a representative body

speaking on behalf of the plastic converting industry

FREP is a panel of experts in food contact material

(plastic) regulation

Mission Statement

• STRATEGY: Develop strategies and proposals for legislation’s

changes, promote them within the plastic chain stakeholders and

in front of DGSANCO and the EU Commission;

• COMMUNICATION: Participate in workshops and conferences

dealing with food contact subjects, releasing speeches when

appropriate;

• INFORMATION: Provide continuous information to, and seek

feedback from the Panel members;

Mission Statement

• VISIBILITY: Participate in Commission’s panels, inter-industry

groups, task forces and other ad-hoc groups which carry out

activities related to all regulatory matters related to the use of

plastics in contact with food;

• INVOLVEMENT: Carry out or participate, when appropriate, in

internal or inter-industry projects aimed at fostering new

legislation’s concept, or understanding the consequences of

legislation’s changes, introduction of norms or industry practices

on members’ business;

• PROACTIVITY: Exert surveillance on incoming legislation,

norms, guidelines and industrial good manufacturing and hygiene practices,

providing feedback in line with the EuPC strategy.

Membership :

• Members of FREP are :

• Plastics converting, compounding or recycling organizations

in the EuPC network

• Plastics converting, compounding or recycling companies

within the EuPC network

• Plastics converting, compounding or recycling companies

located in the European Economic Area when no National

association is member of EuPC

Structure :

• Panel Steering committee

• Plenary

• Task Forces can be set-up on a need basis

Why being member of FREP

• Intervening into building of regulation => right to provide comments on draft (changes have already been made regarding comments made by FREP),

• Understand what others do,

• Give advice on interpretation of legislation,

• Links with other groups inside and outside the scope of FREP (Plastics Europe, PRE, printing inks association, Food&Drink Europe,…),

• Representing to DG SANTE,

• Brainstorming on the future of the Food Contact Materials legislation,

• Be strong and representative of the plastic food contact industry

What FREP has done/is doing

• MATRIX : FREP and industry effort

• FACET : participation in FACET project

• Guidelines : contribution to the redaction of

• DoC, exchange of information

• Migration testing

• Interpretation 10/2011

• Participating in consultations for amending Food contact Regulation

• Links with other groups inside and outside the scope of FREP (Plastics Europe, PRE, printing inks association, Food&Drink Europe,…)

• JRC collaboration to identify and develop a method to measure NIAS

• Workshops and trainings

• Brainstorming on the future of the Food Contact Materials legislation,

Thank you for your attention

• more info via:

[email protected]

and

[email protected]



Date post:	23-Sep-2020
Category:	Documents
Upload:	others
View:	4 times
Download:	0 times

Agoria Food Contact Materials seminar Plasticsagoria.be/RNevent/presentations/Presentatie...

Documents