THE BELGIAN NATIONAL REGISTRY OF NANOMATERIALS: WHAT YOU NEED TO KNOW

Transcription

1 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 1 THE BELGIAN NATIONAL REGISTRY OF NANOMATERIALS: WHAT YOU NEED TO KNOW FPS Health-Environment Chemicals Risk Management Unit Catheline Dantinne May 19th, 2015

2 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 2 ROYAL DECREE OF MAY 27 TH 2014 CONCERNING THE PLACING ON THE MARKET OF MANUFACTURED SUBSTANCES IN NANOSTATE Entry into force: Substances: January 2016 Mixtures: January 2017 Articles/complex objects: to be determined => Today s focus: substances and mixtures

3 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 3 Purpose of the Royal Decree: Establishment of a register of manufactured substances in nanostate placed on the market in Belgium Two main questions: 1. Do I have to register? 2. Modalities of the registration?

4 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 4 SUBSTANCE / MIXTURE: OBLIGATION TO REGISTER?

5 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 5 1 substance or 1 mixture = 1 registration = 1 registration number Even if several manufactured substances in nanostate in the mixture

6 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 6 For mixtures, the registration includes: Information concerning all nanosubstances which fulfill the conditions

7 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 7 I PLACE A SUBSTANCE / MIXTURE ON THE MARKET, DO I HAVE TO REGISTER? Decision tree 9 questions

8 Substances Substance = Biocide, Medicinal product for human or veterinary use, (Product intended to come into contact with) Foodstuff, Animal feed Technological aid or other product that may be used for processing ingredients of agricultural origin yes no Manufacturer / importer no no BtoB distributor yes yes «manufactured substance in nanostate», i.e. : Fullerenes, graphene flakes or single wall carbon nanotubes with one or several external dimensions less than 1 nanometer no non-chemically modified natural substance NO REGISTRATION yes no REGISRATION yes yes Nanostate = by-product of human activity (nonintentional) no no Substance containing particles, in an unbound state or as an aggregate or 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 to 100 nanometers no yes + than 100 gr. / calendar year in total yes

9 Mixtures yes Mixture = Biocide, Medicinal product for human or veterinary use, (Product intended to come into contact with) Foodstuff, Animal feed or Technological aid or other product that may be used for processing ingredients of agricultural origin no Manufacturer / importer no no BtoB distributor yes yes Mixture contains 1 substance(s) which «manufactured in nanostate», i.e. : NO REGISTRATION Fullerenes, graphene flakes or single wall carbon nanotubes with one or several external dimensions less than 1 nanometer no yes Non-chemically natural substance modified Nanostate = by-product of human activity (non-intentional) no REGISTRATION Information concerns only the nanosubstances which fulfill all the conditions yes yes no no Substance = nanomaterial = a substance containing particles, in an unbound state or as an aggregate or 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 to 100 nanometers yes yes Nanosubstance = (insoluble) pigment no no + than 100 gr./nanosubstance/calendar year yes

10 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 10 Question 1: Substance / mixture placed on the market =: Biocide (reg. 528/2012 or RD ) Medicinal product for human or veterinary use (reg. 726/2004 or RD or law ) (Product intended to come into contact with) Foodstuff (law ) Animal feed (reg. 178/2002 or law ) Technological aid or other product that may be used for processing ingredients of agricultural origin (reg. 889/2008) YES: no registration NO: => question 2

11 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 11 Question 2: I place a substance on the market: I am the manufacturer or the importer of that substance I place a mixture on the market: I am the manufacturer or the importer of that mixture YES: => Question 4 NO: => Question 3

12 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 12 Question 3: I am a BtoB distributor (nanosubstance placed on the market exclusively for professional users) OR => Question 4 I distribute the substance/mixture (also) to consumers (placed on the market for consumers / for consumers and professional users) No registration

13 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 13 Question 4: The substance: / The mixture contains one (or several) substance which: is composed of fullerenes, graphene flakes or single wall carbon nanotubes with one or several external dimensions less than 1 nanometer NO: => Question 5 YES: => Question 8

14 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 14 Question 5: The substance: / The mixture contains one (or several) substance which: Is a non-chemically modified natural substance YES: no registration NO: => Question 6

15 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 15 Question 6: The nanostate of the substance is a byproduct of human activity (non-intentional production of nanosubstance) For instance, not a by-product when: Manufacture is the result of a technical choice Nanosubstance is not necessary to manufacture the mixture YES: no registration NO: => Question 7

16 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 16 Question 7: The substance: / The mixture contains one (or several) substances which: contains 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 to 100 nanometers NO: no registration YES: => Question 9

17 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 17 Question 8: ONLY FOR MIXTURES The nanosubstance(s) in the mixture is a pigment YES: no registration NO: => Question 9

18 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 18 Question 9: + than 100 grams of: The substance NO: no registration one or several of the nanosubstances contained in the mixture = placed on the market / year & / company (& / substance) YES: registration of the substance / the mixture

19 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 19 SIMPLIFIED / LIMITED REGISTRATIONS

20 20 1. Transmission of registration number Technical information on the registered nanosubstance(s) may be replaced by the registration number: received from your supplier (foreign company may register as well) from other similar registrations (e.g. French nanoregistry, registered substance used in mixture)

21 21 2. Scientific and industrial research For substances and mixtures, exclusively aimed at scientific research and development activity or research and development activity focusing on products and processes Certificate with declaration on honor that the material will not be placed on the market 1. Registrant identification 2. Limited identification of the substance(s) contained in the registered mixture, namely the chemical identification + Annex 6

22 22 OVERVIEW ANNEXES

23 SPF SANTE PUBLIQUE, SECURITE DE LA CHAINE ALIMENTAIRE ET ENVIRONNEMENT 23

24 24 MODALITIES OF THE REGISTRATION

25 25 Timeline First Registration Existing substances < 1/1/2016 Existing mixtures < 1/1/2017 New substances/mixtures < Placing on the market Annual update Existing substances: 1/1/ /3/2017 Existing mixtures: 1/1/ /3/2018 New substances/mixtures: 1/1 31/3 /year after placing on the market

26 26 First registration First registration substance / mixture (annex 1 / 2 of the RD) 1. Identification of the declarant 2. Identification of the substance / substance(s) contained in the mixture 3. Estimation of the amount of substance / substance(s) in the mixture that will be placed on the market 4. Use of the substance / mixture 5. Identity of the professional user(s) whom the declarer supplies with the substance / mixture (if known)

27 27 Annual update Annual update (annex 3 / 4 of the RD) 1. Identification of the declarant if changes 2. Identification of the substance / substance(s) contained in the mixture if changes 3. Total amount of substance / substance(s) in the mixture placed on the market in the previous year 4. Use of the substance / mixture if changes 5. Identity of the professional user(s) whom the declarer supplied with the substance / mixture during the previous year

28 28 Identification of declarant Identification of the declarant: by creating a user and an account

29 29 Identification of declarant A user (person) cannot exist without an account (company) and vice versa An account can have >1 users A user can have >1 account 3 types of users: Read Read, write Read, write, administrator (= user management)

30 30 Identification of substance Identification of the substance - obligatory part: Chemical identification (name, formula, CAS-number, CEnumber) Size of the particles Particle size distibution curve number based Size aggregates and agglomerates Qualititive description of the shape of the particles If applicable: qualitative description of the coating of the particles

31 31 Identification of substance Identification of the substance - to complete if available: REACH-registration number Impurities (> 0,1% w/w or when due to other legislations) Crystallographic phases Specific surface area Zeta-potential

32 32 Identification of mixture Identification of the mixture same as for a substance except: Option: information of the substance(s) as present in the mixture Information of the substance(s) before integrated in the mixture New concept: category of mixtures If = nanosubstance(s) If = use If = concentration => possible to register the category as one registration

33 33 Practical: Substance

34 34 Practical: Mixture General info Mixture Substances Totaal aantal stoffen in het/de mengsel(s): 3 automatisch; minimaal 1 Stof toevoegen Name of the substance < 100 g? X Details X Details X Details Cancel Save Next

35 35 Quantity & Use Quantity For a substance: total amount of registered substance For a mixture: Total amount of each registered substance Concentration (w/w) of the substance(s) State of the substance(s) integrated in the mixture Use Use of the substance / mixture Commercial name(s) Optionally: claimed properties of the registered substances

36 36 Identity professional users Identity of the professional users

37 37 Information on substances / mixtures Possible to save anytime List of commercial names and list of professional users can be uploaded or completed manually Overview status: General info Substance Identity of the professional users Confirmation General info Substance Chemical identification Particle size Distribution curve Aggregates and agglomerates Shape of the particles Coating Impurities Crystallographic phases Mean specific surface area Surface charge Quantity Use Additional remarks and info Completeness Identity of the professional users Submit

38 38 Submitting your registration Submit: only possible when all the required information is completed (or by motivated exception) Export to pdf-file is possible Confirmation by -> registration has been submitted Overview of your registrations + status Home My account My dossiers New dossier Name of the enterprise Name of the user

39 39 PRACTICAL EXAMPLES

40 40 Belgian Producer of a NMM & material sold in BE NMM= Full registration BE Producer NM BELGIUM Quantities = quantities placed on the BE market ( > 100g) Annex 1

41 41 Belgian producer of a mixture containing NM ( > previous example) NM in The Mixture = Full registration BUT you can use the registration number of the NM limited registration BE P. of Mixture BELGIUM Quantities = quantities placed on the BE market ( > 100g) Annex 2 or limited annex2

42 42 You re buying /using and selling to professionals users ( NM or Mixture with NM) You have recieved a registration number from your BE supplier Limited registration BE.ENTR=Prof User BELGIUM PRO Quantities = quantities placed on the BE market for your clients=professional users

43 43 You re buying /using and selling to professionals users and consumers ( NM or Mixture with NM) outside NO registration! PRO BELGIUM Consumers

44 44 You re importing in BE a NM or a Mixture IMPORTER = Prof User NM or Mixture with NM 1 IMPORTER BELGIUM Quantities = quantities imported in the BE market ( if > 100g) 1. It s a full registration ( annex1 or annex2) but your supplier outside BE can also register*. And give you a registration number. ( CBI ) -> limited registration * A French number will also be an option but we are still discussion with our FR colleagues

45 45 You re importing in BE a NM or a Mixture and selling to Prof users 1 IMPORTER = Prof User NM or Mixture with NM IMPORTER BELGIUM PRO Limited registration + quantities placed on the market for Prof Users Both registrations ( 1 and2) will be merged in practice for simplification

46 46 Way forward Registry will be available from September 2015 Testing for declarants: June July - August 2015 HELP? Guidance Helpdesk FAQ s Documents available on-line Feedback & input always welcome!

47 47 Upcoming events 1. Round Robin Project of FPS Economy Metrology Timing: Start: 01/05 Agree on protocol: 30/06 Measurements: july/august results send : 01/09 Presentation of the results (anonymously) : 01/10 2. Workshop Nano in Belgium Project of FPS Work, FPS Economy and FPS Public Health October 2015, Brussels

48 48 Contact adresses Workshop Nano in Belgium : agnieszka.dobrak@milieu.belgie.be Registry: carine.gorrebeeck@milieu.belgie.be

49 49 Thank you for your attention!