Impact of nano-regulation through the supply chain: …• Titanium dioxide (E171), Iron oxides and hydroxides (E172), Silver (E174) and Gold (E175) • 31 December 2016: Silicon dioxide

© 2017 Nanotechnology Industries Association

Impact of nano-regulation through the supply chain: from safety data sheets to

labelling and food contact case study

20-22 March 2017, Amsterdam, The Netherlands

Dr David CarlanderNIA Director Regulatory Affairs

21 March 2017

www.nanotechia.org

http://www.nanotechia.org/

NIA supports the development of nanotech innovations that improve the lives of consumers, preserve our environment and advance our world

• Support development and application of a robust regulatory framework

• Business and scientific networking and promotion for Members

• Working to build the nanotechnology ecosystem

NIA: the voice of nanotechnology industries

Brussels Head Office

Team in Belgium, UK, France,

Netherlands, Sweden/Portugal

Skills in regulatory

development, project delivery,

advocacy and communications

Global Business Summit 201720-22 March 2017, Amsterdam, The Netherlands © 2017 Nanotechnology Industries Association

Compliance with the nano definition

Food and food contact material labelling

Nano-assessment under the Biocidal Product Regulation

REACH and ECHA updates

Fiberlean® FMC


Things that I will talk about

Revision of European Commission 2011 Nanomaterial Definition Recommendation

[http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF]


http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF

• Identified issues

– Clarifications possible for several terms:

• ‘particle’, ‘physical boundary’, ‘unbound state’, ‘constituent particle’, ‘external size’ and ‘aggregate’, ‘one or more external dimensions’ as well as the verb ‘containing’

– How to identify particles in aggregates

– Inconsistency in the 1-50 % flexibility

– Confusion on the Volume Specific Surface Area (VSSA)

– How to prove a material is not a nanomaterial

• Public consultation (8 weeks) expected March/April

• Exclusions? Three options for public consultation: Maintain, Exclude, Addition

• Accompanied by JRC guidance document

• Likely EC adoption 2nd half 2017


Revision of European Commission 2011 Nanomaterial Definition Recommendation

Food labelling and packaging


The EU Nanomaterials Food Policy Plate– Comprehensive RegulatoryCoverage

General Food Law (178/2002)

Food Information to Consumers (1169/2011)

Food Additives(1333/2008)

Food Contact Materials

(1935/2004)

Active and Intelligent Food

Contact Materials (450/2009)

Plastic Materials(10/2011)

Novel Foods(2015/2283)


Regulation on Food Information– (EU No1169/2011

Labelling from 13 December 2014: Ingredient XX (nano)

Spring 2016 meeting with FoodDrink Europe:

– Not aware of any intentional use of nano– No labelling found


• Engineered nanomaterials require authorisation before being used in food

• Applicants need to demonstrate the scientificappropriateness of the test method [Article 10.4]

• EU legal definition of engineered nanomaterials is now in the Novel Food Regulation [Article 3.2.f]

Replaces the same definition currently in Regulation (EU) 1169/2011 Food Information to Consumers

EU Novel Food Regulation (EU) 2015/2283 –With nano-specifics


Scientific opinion, adopted 28 June 2016

• Re-evaluation of titanium dioxide (E 171) as a food additive

– ‘would not be considered as a nanomaterial’

Statement, adopted 11 May 2016

• Presence of microplastics and nanoplastics in food, with particular focus on seafood: Limited/no data on micro/nanoplastics

Scientific Opinion, adopted 10 February 2016

• Safety assessment of the substance zinc oxide, nanoparticles, for use in food contact materials: Does not migrate in nanoform

Scientific Opinion, adopted 18 March 2015

• Scientific Opinion on the safety evaluation of the substance zinc oxide, nanoparticles, uncoated and coated with[3-(methacryloxy)propyl] trimethoxysilane, for use in food contact materials: Does not migrate in nanoform

EFSA – Selection of Recent AdoptedOpinions


Re-evaluation programme on food additives (Commission Regulation (EU) No 257/2010):

• Vegetable carbon (E153)http://www.efsa.europa.eu/en/efsajournal/doc/2592.pdf

• Calcium carbonate (E 170)http://www.efsa.europa.eu/en/efsajournal/doc/2318.pdf

The re-evaluated product is not a nanomaterial

• Titanium dioxide (E171), Iron oxides and hydroxides (E172), Silver (E174) and Gold (E175)

• 31 December 2016: Silicon dioxide (E551)

• 31 December 2018: Calcium silicate (E552), Magnesium silicate (E553a) and Talc (E553b).


http://www.efsa.europa.eu/en/efsajournal/doc/2592.pdf

http://www.efsa.europa.eu/en/efsajournal/doc/2318.pdf

General framework, and vertical legislations (e.g. plastics) but also national regulations in place for other FCM materials (e.g. paper)

EU harmonised – most notable

• Framework regulation (EC) No 1935/2004 (Nano not mentioned)

• Active and intelligent materials regulation (EC) No 450/2009 (Nano)

• Plastic regulation (EU) No 10/2011 (Nano)

National regulations

• Available for various packaging, not nanospecific

EU Food Contact Materials Legislation


Regulation on Plastic Food Contact Materials (EU No 10/2011)


Substances in nanoform

• Risk assessment required for the form to be used

– Substances in nanoform can only be used when they have been subject to risk assessment and authorised in the nanoform

• Substances with reference to nanosize included in the positive list (Annex I) of authorised substances (size specification included in the list)• Carbon Black,

• (Butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer; crosslinked with divinylbenzene, crosslinked with 1,3-butanediol dimethacrylate or not cross-linked,

• Titanium nitride

• Silicon dioxide

• Kaolin

Regulation on Plastic FCM (EU No 10/2011)


Biocidal Products


• Applicable from 1 September 2013

• Risk Assessment to be performed by

Regulation (EU) No 528/2012 Concerning the making available on the market and use of biocidal products


Nanomaterials in the BPR (EU 528/2012)


Article 3.1.z Definitions

Nanomaterial “means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm…

Article 4.4 Conditions for approval

The approval of an active substance shall not cover nanomaterials except where explicitly mentioned

Article 58.3.d Placing on the market of treated articles

...the name of all nanomaterials contained in the biocidal products,followed by the work ‘nano’ in brackets

• Decision based on an Assessment Report submitted by France on 18 December 2015

• ECHA Biocidal Products Committee (BPC) adopted on 11October 2016 an Opinion on the application for approvalof the active substance:

• Pyrogenic, synthetic amorphous silicon dioxide, nano, surface treated– Product Type 18 (Insecticides, acaricides and products to control other

arthropods)

• Shall be included in the Union list of approved active substances

– The active substance is not a candidate for substitution, and does not meet the criteria for being a persistent organic pollutant


Synthetic Amorphous Silicon dioxide (SAS)

• Primary particle size: 6.9-8.6 nm

• Specific surface area: 217-225 m2/g;

• Size of stable aggregated particles: > 70 nm

• The active substance is a nanomaterial according to thedefinition set out in Article 3(1)(z) of Regulation (EU) No528/2014

• Dossier previously examined under Regulation (EC) No 1451/2007 (Review programme)

Synthetic Amorphous Silicon dioxide (SAS)


REACH and ECHAupdates


Modification of REACH Annexes – EC non-paper (March 2017)

• Regulatory definition (based on EC recommendation) to be inserted in Annex VI

• ‘Nanomaterial’ will be defined as ‘nanoform’– In one registration a substance can have several forms (sets)

– Nanoform require information on:

• Size/Shape/Surface modification…

• ECHA currently updating four guidance documents

– Identification of nanoform

– Read across between nanoforms of the same

substance

– Specific aspects of hazard assessment for human health and the environment

• Currently EC non-paper is discussed at the REACH Committee. Official proposal expected shortly


• General clarification (in Annex I, XII)

– If nanoforms are covered by the registration, they must be addressed, assessment and conclusions documented and appropriate risk management measures identified

• Introduction of requirements to provide information on nanoforms in Annexes I, III, VI-XII

– For characterisation: ‘Size, Shape, Surface modification’(Name, particle number size distribution, surface functionalization/treatment,

shape, aspect ratio, morphology, surface area, analytical methods)

– Specify test conditions

– Confounding effects related to dispersion

– Cancel waiving of testing based on high solubility in water alone

– Dustiness information etc….


Nano-specific modifications of REACH Annexes– Proposed modifications (EC non-paper)

• Agreement signed between ECHA and EC end 2016

• ECHA plans three phases of the EUON:1. 2017 – Use synergies: Available data and information

• Expected launch of microsite in June 2017

2. 2018 – Expansion of content

3. 2019 – Fully operational

European Observatory on Nanomaterials – EUON


• Decision adopted 2 March 2017 (case number A-011-2014)

• BoA decision follows REACH text!

• BoA annuls ECHA decision to ask for more information related to ‘substance identity’

– Note! Decision is not related to ‘substance evaluation’!

• BoA decision on SiO2 for ‘Substance evaluation’ expected in April

ECHA Board of Appeal – TiO2

A-011-2014 1(14)

DECISION OF THE BOARD OF APPEAL

OF THE EUROPEAN CHEMICALSAGENCY

2 March2017

(Dossier evaluation – Compliance check –

Substance identity – Nanomaterials – Nanoforms)

Case number A-011-2014

Language of the case English

Appellants Huntsman P&A UK Limited, formerly Tioxide Europe Limited,United Kingdom

Cinkarna Metalurško-kemična Industrija Celje d.d., Slovenia

• Registrant decide on substance ID• ECHA can not request information

outside REACH text specifications for Substance Identity


• TiO2 assessment provided by ANSES (FR) in May 2016 for Harmonised Classification and Labelling proposal for TiO2 as Carcinogen cat 1B (via the inhalation route)

• First discussion held in ECHA Risk Assessment Committee (RAC) 14 March 2017

• Continued discussions in RAC meeting June 2017

• Adoption in November 2017 following 18 month timeframe

ECHA TiO2 under Classification, Labelling and Packaging Regulation (CLP)


Fiberlean® MFC


• FiberLean® MFC is a composite produced by co-grinding cellulose fibers with minerals (Ground Calcium Carbonate, Precipitated Calcium Carbonate or Kaolin) based on a proprietary patented process

• Some primary fibers of nanoscale dimension followinge.g. the EC definition of nanomaterial

• Large potential use: Cement, Automotive, Coatings, Fillers, Plastic packaging, Absorbants, Aerospace, Aerogels, Sensors, Drug delivery, Cosmetics etc…

FiberLean® MFC – MicroFibrillatedCellulose


FiberLean® MFC – Approximate dimensions


• Food Contact Notification submitted to FDA

– With performed testing: Characterisation, migration, exposure etc…

• The FDA assessment became effective in November 2015 for use as a food contact substance in paper and paperboard for food packaging applications

• Health Canada January 2016; No reason to object the use of the substance

FiberLean® MFC Food Contact Substance assessed by FDA and Health Canada


Industrial Workshop on Safe-By-Design

Free of charge – Registration:https://www.bionanonet.at/component/chronoforms5/?chronoform=form2

24-25 April

2017

Bilbao

• Introduction to the Safe-by-Design concepts to a wider audience

• Development of new relationships between the Horizon 2020 projects involved in Safe-by-Design and industrial stakeholders

• Bringing together industrial companies who can benefit from the use of Safe-by-Design


http://www.bionanonet.at/component/chronoforms5/?chronoform=form2

© 2017 Nanotechnology Industries Association

@nanotechia

www.nanotechia.org

Dr David CarlanderDirector Regulatory Affairs Nanotechnology Industries Association m: +32 491 399 441e: [email protected]: www.nanotechia.org

BrusselsNanotechnology Industries Association (aisbl) 143 Avenue de Tervuren1150 Woluwe-Saint-Pierre, Brussels Belgium

Thank you!


mailto:[email protected]


Documents

Impact of nano-regulation through the supply chain: …• Titanium dioxide (E171), Iron oxides and hydroxides (E172), Silver (E174) and Gold (E175) • 31 December 2016: Silicon dioxide