NIAS in Packaging & Moca - Tuv · NIAS in Packaging & Moca pH s.r.l. - TÜV SÜD Dr.ssa Elisabetta...

NIAS in Packaging

& MocapH s.r.l. - TÜV SÜD

Dr.ssa Elisabetta Silvestrini

TÜV SÜD Italia NIAS in Packaging & MOCA06-12-2016

Agenda

1 Introduzione: cosa sono i NIAS?

2 Risk assessment di NIAS

3 Case study in pH - TÜV

4 Conclusioni

TÜV SÜD pH Slide 2NIAS in Packaging & MOCA06-12-2016TÜV Italia - Gruppo TÜV SÜD Slide 2

TÜV Italia - Gruppo TÜV SÜD Slide 3

Non Intentionally Added Substances (NIAS)

In Article 3 of Regulation EU 10/2011, NIAS are defined as follows:

‘Non-intentionally added substance’ means an impurity in the substances used or a

reaction intermediate formed during the production process or a decomposition or

reaction product” (EU, 2011)

Degradation processes

Degradation of additives ( antioxidants , light

stabilizers )

Impurities in the raw materials

Newly formed compounds

Contaminants resulting from the recycling

process of materials

Where do they come from?

They migrate from packaging into food

They are a source of hazardous contamination or

less depending on their toxicity

Where do they go?

NIAS in Packaging & MOCA

IAS: sostanze aggiunte intenzionalmente

NIMS: sostanze migranti non identificate

06-12-2016TÜV SÜD pH Slide 3

European regulations on NIAS

GMP Regulation (2023/2006)

General requirement to implement a system of quality assurance, quality control,

and maintain supporting documentation

EU Regulation (1935/2004): article 3

Materials and articles, including active and intelligent materials and articles,

shall be manufactured in compliance with good manufacturing practice so

that, under normal or foreseeable conditions of use, they do not transfer

their constituents to food in quantities which could:

(a) endanger human health; or (b) bring about an unacceptable change in

the composition of the food; or (c) bring about a deterioration in the

organoleptic characteristics thereof.

TÜV SÜD Italia Slide 4NIAS in Packaging & MOCA06-12-2016


EU Plastic Regulation (10/2011 amended 6 times, the 6th amendment Reg.

1416/2016) This is the first Regulation that introduce term “NIAS”

Consideranda 18) Substances used in the manufacture of plastic materials or

articles may contain impurities originating from their manufacturing or extraction

process. These impurities are non-intentionally added together with the substance

in the manufacture of the plastic material (non-intentionally added substance –

NIAS). As far as they are relevant for the risk assessment the main impurities of a

substance should be considered and if necessary be included in the specifications

of a substance. However it is not possible to list and consider all impurities in the

authorisation. Therefore they may be present in the material or article but not

included in the Union list

- Aids to polymerization and NIAS may be present in plastics provided

- Safe; risk assessment in accordance with Article 19

- No change foreseen in the 6th amendment



EC Guidelines on the Plastics Regulation:

If no specifications are listed under column 10 of Annex I, table 1,

this does not mean that all purities of a substance are suitable

Impurities in substances = NIAS => to be evaluated in accordance

with Article 19

EU Plastic Regulation (10/2011 amended 6 times, the 6th amendment Reg.

1416/2016)

Article 19

Assessment of substances not included in the Union list Compliance with Article 3

of Regulation (EC) No 1935/2004 of substances referred to in Articles 6(1), 6(2),

6(4), 6(5) and 14(2) of this Regulation 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.

The scientific principles for risk assessment should also include the exposure of the substance



NIAS

DECLARATION OF COMPLIANCE

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.

Therefore an optimized exchange of information along the supply chain is

key to ensure the compliance of the final article. DoC should give right

information for extra compliance work from supplier to the custmer

Agenda




4 Conclusioni


Risk assessment


As required by Article 19 of the European Commission Regulation (EU)

No. 10/2011, the risk of NIAS is to be assessed

Two different strategies for different types of NIAS:

1. Substance-specific risk assessment for the predictable NIAS

(Target approach)

2. Risk assessment of unidentifiable unpredictable NIAS:

Screening (Non-target approach)

Non-target analytical techniques

for the evaluation of NIAS

• Screening techniques

•The screening technique allows us to detect, by appropriate instrumental analysis, the presence of

expected and unexpected molecules

•The use of an appropriate internal standard allows us to semi-quantify such molecules, providing a

starting point for the risk assessment of the contaminants present in the migration extracts


S.I.

NIAS in Packaging & MOCA06-12-2016TÜV SÜD pH Slide 10

Risk assessment strategy of NIAS

Aims of the strategy


Prioritizing the evaluation of NIAS according to

their toxicological characteristicsDiscrimination of NIAS

Avoid unnecessary analytical tests for molecules

of low interest for the health of the consumer

Saves time,

inexpensive

Concentrate all resources on assessment of

dangerous molecules

Complete and detailed

evaluation

1

2

3



Risk assessment of NIAS

TTC: Threshold of Toxicological Concern (I/II)

• TTC is a pragmatic risk assessment tool

• It is based on the principle of establishing an exposure threshold for all substances below which

there is a very low probability of an appreciable risk for humans (Kroes et al., 2004)

This threshold is estimated based on Cramer toxicological classification:

Class ISimple structures efficiently metabolized to innocuous products;

anticipated low order of oral toxicity

Class II

Intermediate structures;

less innocuous than substances in Class I, but no positive indication

of toxic potential

Class IIIComplex structures;

metabolism to reactive products suggesting potential toxicity



TTC: Threshold of Toxicological Concern (II/II)

Translate response into intake and identify

peaks corresponding with intakes exceeding

exposure threshold

Using a known amount of Internal Standard

corresponding to the threshold of exposure

Evaluation of molecules that exceed this

threshold

I

II

III

TÜV Italia - Gruppo TÜV SÜD Slide 13NIAS in Packaging & MOCA06-12-2016TÜV SÜD pH Slide 13


General analytical screening

Combination of techniques covering a broad spectrum of substances:


Headspace/

SPME GC-MS

Volatile

substances

GC-MSSemi-volatile

substances

LC-MSNon-volatile

substances


General analytical screening: Laboratory facilities for chemical tests

HPLC/Q-TOF-MS

TÜV SÜD pH Slide 15NIAS in Packaging & MOCA06-12-2016

HPLC-FLD

UV-VIS SPECTOPHOTOMETER

General analytical screening: Laboratory facilities for chemical tests

• GC-MS SHIMADZU


Screening of NIAS using HPLC / MS-QTOF


The third quadruple of a triple

quadrupole is replaced by a

time of flight (Q-TOF)

Accurate measurement

of mass


Screening of NIAS using HPLC / Q-TOF-MS

•A major limitation: limited distribution of libraries relative to the typical compounds found in plastics

•For this reason, lab has provided for the creation of a specific library containing NIAS found through

a long research in the literature

•The library is constantly growing and currently has more than 4000 molecules


Agenda




4 Conclusioni


Case study: fazzoletti di carta con odore anomalo


Screening HS-GC/MS: 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (CAS 126-86–3) con

semiquantitativa circa 60 ppb

La molecola è stata riscontrata sia nella carta che nella plastica

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwj_lZPMldXQAhWDPxoKHRO4AOYQjRwIBw&url=http%3A%2F%2Fwww.shopstock.net%2F36-fazzoletti&psig=AFQjCNG4f_AnimQsz-AYSqW8gxSVLKH33w&ust=1480756381769299

http://www.google.it/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwj_lZPMldXQAhWDPxoKHRO4AOYQjRwIBw&url=http%3A%2F%2Fwww.shopstock.net%2F36-fazzoletti&psig=AFQjCNG4f_AnimQsz-AYSqW8gxSVLKH33w&ust=1480756381769299

Case study: fazzoletti di carta con odore anomalo


It is highly toxic and have been found in acrylic adhesives used for food

packaging multilayers manufacturing.

Case study: tappi colorati per barattoli


Lo screening GC-MS per le sostanze semi-volatili ha

mostrato la presenza di alcune molecole:

1) Benzene, 1,3-bis(1,1-dimethylethyl)- circa 1 ppm ed

avente alta tossicità.

2) Phenol, 3,5-bis(1,1-dimethylethyl)- , circa 800 ppb ed

avente bassa tossicità, si segnala ugualmente vista la

quantità rilevante

3) 95906-11-9_Tris(2,4-di-tert-buthylphenyl)phosphate, circa

3 ppm ed avente alta tossicità.

4) IRGAFOS, circa100 ppb, ed avente alto grado di tossicità.

(limite PIM 60 ppm)

https://www.google.it/imgres?imgurl=http%3A%2F%2Fwww.chedonna.it%2Fwp-content%2Fuploads%2F2014%2F11%2FAmicoAmbiente_fotoTappi-017-e1417194710890.jpg&imgrefurl=http%3A%2F%2Fwww.chedonna.it%2F2014%2F11%2F29%2Friciclo-creativo-simpatici-segnaposto-con-semplici-tappi-di-plastica%2F&docid=ZNiDpkzkyg9glM&tbnid=vX10cbBu9eSNhM%3A&vet=1&w=940&h=626&bih=911&biw=1920

https://www.google.it/imgres?imgurl=http%3A%2F%2Fwww.chedonna.it%2Fwp-content%2Fuploads%2F2014%2F11%2FAmicoAmbiente_fotoTappi-017-e1417194710890.jpg&imgrefurl=http%3A%2F%2Fwww.chedonna.it%2F2014%2F11%2F29%2Friciclo-creativo-simpatici-segnaposto-con-semplici-tappi-di-plastica%2F&docid=ZNiDpkzkyg9glM&tbnid=vX10cbBu9eSNhM%3A&vet=1&w=940&h=626&bih=911&biw=1920

Case study: tappi colorati per barattoli


A real case study:

Screening non-volatile substances by HPLC-Q-TOF-MS

TÜV Italia - Gruppo TÜV SÜD Slide 24NIAS in Packaging & MOCA

Campione: tappo colorato in PET

06-12-2016TÜV SÜD pH Slide 24

Composition: PET

Migration conditions:

Simulant: ethanol 50%

Time: 10 days

T: 40°C


•Screening was performed following a migration test in ethanol 50% for 10 days at 40°C.

Migration extract was sent to instrument

•Screening for non-volatile substances did not detect the presence of significant molecules, both

qualitatively and quantitatively

•To illustrate the potential of our library together with the sensitivity of the analysis tool used, real

cases of internal study in the lab will be shown later.


A real case study



A real case study:

Conclusions

pH-TÜV, after evaluating:

• The list of IAS supplied by the client

• Some screening performed previously by the client

• evaluated critically the data obtained in the tests:

The substances that exceeded the level of interest established with the

client did not exceed the limits prescribed by the law


A real case study: Nysol


Composition: PS

Migration condition:

S= 2 dm2

V= 200 ml

Time= 10 days

T(°C)= 40

Campione: lastra in polistirene


06-12-2016TÜV SÜD pH Slide 28NIAS in Packaging & MOCA

Dioctyl sulfosuccinate sodium salt (Nysol)

Is used as surfactant, wetting agent, is

able to form microemulsions

without the use of co-surfactants, and

has a rich variety of aqueous-phase

behavior including multiple liquid

crystalline phases; It is used to

prepare reverse micelles.

A real case study:


TÜV Italia - Gruppo TÜV SÜD Slide 2506-12-2016TÜV SÜD pH Slide 29NIAS in Packaging & MOCA

Agenda

4 Conclusioni





Conclusion


The pH-TÜV laboratory with

its highly sensitive

instruments and with a

growing database, can

provide comprehensive and

detailed analysis on the

assessment of NIAS present

in the migration of packaging

extracts.

NIAS

Even if the term “NIAS” is introduced for the first time in Reg.

10/2011 for plastic, the concept can also be extended to other

materials as metals, paper, coating,…as well as printing, inks,

resins, adhesives.

In conclusion:

To identify NIAS it is necessary transparency, clarity and

collaboration between producer, supplier and laboratory


Elisabetta Silvestrini

Food Contact Expert AIBO n°142

[email protected]

Grazie per

l’attenzione


Per saperne di più sui

Sistemi di gestione:

www.tuv.it/ph

Per saperne di più sui

servizi TÜV Italia:

www.tuv.it

Per saperne di più…

TÜV Italia

Per saperne di più sulla

formazione Akademie:

www.tuv.it/akademie

I corsi TÜV Italia Akademie sull’argomento:

› Food Contact - Introduction

› Food Contact – advanced level

› La normativa vigente nel settore alimentare

› Allergie alimentari: dagli aspetti molecolari alle problematiche nel processo di produzione

alimentare

› Etichettatura dei prodotti alimentari: le novità del Regolamento CE 1169/2011

http://www.tuv.it/ph

http://www.tuv.it/

http://www.tuv.it/akademie

http://www.tuv.it/it-it/attivita/tuev-italia-akademie/catalogo/sicurezza-prodotto/food-contact-introduction

http://www.tuv.it/it-it/attivita/tuev-italia-akademie/catalogo/sicurezza-prodotto/food-contact-advanced-level

http://www.tuv.it/it-it/attivita/tuev-italia-akademie/catalogo/sicurezza-prodotto/la-normativa-vigente-nel-settore-alimentare

http://www.tuv.it/it-it/attivita/tuev-italia-akademie/catalogo/sicurezza-prodotto/allergie-alimentari-dagli-aspetti-molecolari-alle-problematiche-nel-processo-di-produzione-alimentare

http://www.tuv.it/it-it/attivita/tuev-italia-akademie/catalogo/sicurezza-prodotto/etichettatura-dei-prodotti-alimentari-le-novita-del-regolamento-ce-1169-2011

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