Impact of nano-regulation through the supply chain: from safety data sheets to labelling and food contact case study

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Amsterdam, The Netherlands Dr David Carlander NIA Director Regulatory

1 Impact of nano-regulation through the supply chain: from safety data sheets to labelling and food contact case study March 2017, Amsterdam, The Netherlands Dr David Carlander NIA Director Regulatory Affairs 21 March Nanotechnology Industries Association

Business and scientific networking and promotion for Members Working to build the nanotechnology ecosystem Brussels Head Office

2 NIA: the voice of nanotechnology industries 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 Brussels Head Office Team in Belgium, UK, France, Netherlands, Sweden/Portugal Skills in regulatory development, project delivery, advocacy and communications

3 Things that I will talk about Compliance with the nano definition Food and food contact material labelling Nano-assessment under the Biocidal Product Regulation REACH and ECHA updates Fiberlean FMC

4 Revision of European Commission 2011 Nanomaterial Definition Recommendation [

Revision of European Commission 2011 Nanomaterial Definition Recommendation Identified issues Clarifications possible for several terms: particle, physical boundary, unbound state, constituent

5 Revision of European Commission 2011 Nanomaterial Definition Recommendation 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 2 nd half 2017

6 Food labelling and packaging

The EU Nanomaterials Food Policy Plate Comprehensive RegulatoryCoverage Food Information to Consumers (1169/2011) Novel Foods (2015/2283) General Food Law

7 The EU Nanomaterials Food Policy Plate Comprehensive RegulatoryCoverage Food Information to Consumers (1169/2011) Novel Foods (2015/2283) General Food Law (178/2002) Food Contact Materials (1935/2004) Food Additives (1333/2008) Plastic Materials (10/2011) Active and Intelligent Food Contact Materials (450/2009)

8 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

EU Novel Food Regulation (EU) 2015/2283 With nano-specifics Engineered nanomaterials require authorisation before being used in food Applicants need to demonstrate the scientific appropriateness of

9 EU Novel Food Regulation (EU) 2015/2283 With nano-specifics Engineered nanomaterials require authorisation before being used in food Applicants need to demonstrate the scientific appropriateness 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

10 EFSA Selection of Recent AdoptedOpinions 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

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.

11 Re-evaluation programme on food additives (Commission Regulation (EU) No 257/2010): Vegetable carbon (E153) Calcium carbonate (E 170) 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).

EU Food Contact Materials Legislation General framework, and vertical legislations (e.g. plastics) but also national regulations in place for other FCM materials (e.

intelligent materials regulation (EC) No 450/2009 (Nano) Plastic regulation (EU) No 10/2011 (Nano) National

12 EU Food Contact Materials Legislation 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

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

Regulation on Plastic FCM (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

14 Regulation on Plastic FCM (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

15 Biocidal Products

16 Regulation (EU) No 528/2012 Concerning the making available on the market and use of biocidal products Applicable from 1 September 2013 Risk Assessment to be performed by

17 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

18 Synthetic Amorphous Silicon dioxide (SAS) Decision based on an Assessment Report submitted by France on 18 December 2015 ECHA Biocidal Products Committee (BPC) adopted on 11 October 2016 an Opinion on the application for approval of 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.

19 Synthetic Amorphous Silicon dioxide (SAS) Primary particle size: nm Specific surface area: m 2 /g; Size of stable aggregated particles: > 70 nm The active substance is a nanomaterial according to the definition set out in Article 3(1)(z) of Regulation (EU) No 528/2014 Dossier previously examined under Regulation (EC) No 1451/2007 (Review programme)

20 REACH and ECHA updates

21 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

22 Nano-specific modifications of REACH Annexes Proposed modifications (ECnon-paper) 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.

23 European Observatory on Nanomaterials EUON Agreement signed between ECHA and EC end 2016 ECHA plans three phases of the EUON: Use synergies: Available data and information Expected launch of microsite in June Expansion of content Fully operational

ECHA Board of Appeal TiO 2 Decision adopted 2 March 2017 (case number A-011-2014) BoA decision follows REACH text!

24 ECHA Board of Appeal TiO 2 Decision adopted 2 March 2017 (case number A ) 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! A (14) DECISION OF THE BOARD OF APPEAL OF THE EUROPEAN CHEMICALSAGENCY 2 March 2017 (Dossier evaluation Compliance check Substance identity Nanomaterials Nanoforms) Registrant decide on substance ID ECHA can not request information outside REACH text specifications for Substance Identity Case number Language of the case A English Appellants Huntsman P&A UK Limited, formerly Tioxide Europe Limited, United Kingdom Cinkarna Metalurško-kemična Industrija Celje d.d., Slovenia BoA decision on SiO 2 for Substance evaluation expected in April

25 ECHA TiO 2 under Classification, Labelling and Packaging Regulation (CLP) TiO 2 assessment provided by ANSES (FR) in May 2016 for Harmonised Classification and Labelling proposal for TiO 2 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

26 Fiberlean MFC

27 FiberLean MFC MicroFibrillatedCellulose 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 following e.g. the EC definition of nanomaterial Large potential use: Cement, Automotive, Coatings, Fillers, Plastic packaging, Absorbants, Aerospace, Aerogels, Sensors, Drug delivery, Cosmetics etc

28 FiberLean MFC Approximate dimensions

FiberLean MFC Food Contact Substance assessed by FDA and Health Canada Food Contact Notification submitted to FDA With performed testing: Characterisation, migration, exposure etc The FDA assessment

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

Industrial Workshop on Safe-By-Design 24-25 April 2017 Bilbao Introduction to the Safe-by-Design concepts

Design and industrial stakeholders Bringing together industrial companies who can benefit from the use of

30 Industrial Workshop on Safe-By-Design 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 Free of charge Registration:

Thank you! Dr David Carlander Director Regulatory Affairs Nanotechnology Industries Association m: +32 491 399 441 e: david.carlander@nanotechia.

31 Thank you! Dr David Carlander Director Regulatory Affairs Nanotechnology Industries Association m: e: w: Brussels Nanotechnology Industries Association (aisbl) 143 Avenue de Tervuren 1150 Woluwe-Saint-Pierre, Brussels Nanotechnology Industries Association

Possible risk assessment for Nano-particles in Food Contact Materials

Possible risk assessment for Nano-particles in Food Contact Materials 4 th Nanotechnology Dialogue FoodDrinkEurope Brussels 5 th October 2011 P.K.T. Oldring Valspar Corporation 1 Nanotechnology and FCM