The Danish register for mandatory registration of nanoproducts. Flemming Ingerslev, Section of Chemicals The Danish Environmental Protection Agency

Transcription

1 The Danish register for mandatory registration of nanoproducts Flemming Ingerslev, Section of Chemicals The Danish Environmental Protection Agency

2 Overview Background and purpose of the registry Preparation of the nano product registry Description of the Danish registry for nano products Current status The Danish Environmental Protection Agency PAGE 2

3 Danish initiative on nanomaterials for Part of the government program of the former Government in DK (New government in DK from June 2015) National Budget Agreement 2012 on Better Control of Nanomaterials and their Safety (~ 3.2 mio , ) Subproject 1: Knowledge building with focus on exposure pathways and implications for consumers and the environment with regard to the use of nanomaterials (approx. 3/4 of budget) Subproject 2: Development of a nano product register in cooperation with other countries (approx. 1/4 of budget) The Danish Environmental Protection Agency PAGE 3

4 Projects under the Danish nano-initiative Use/occurrence of NM Database Supplementary surveys 1. Guidance documents and help desk 2. Release from printer toner cartridges 3. Release from selected consumer products 1. NM s in food, food contact materials, cosmetics, pesticides 2. NM s in pigment 3. NM s in waste Assessment of specific products 1. Products with photocatalytic titanium dioxide 2. Aerosol products with nanomaterials 3. Textiles with nanosilver Processes and fate of NM Effects of NM 1. Oral and dermal uptake 2. Fate processes in the enviroment 3. Human exposure 1. Ecotoxicology 2. Toxicology Potential Environmental and health risks due to nanomaterials in DK

5 Timeline and preparations Report on administrative burdens. Environment Project no. 1451, 2012 Report on possible limitations to administrative burdens. Environment Project no , 2012 Agreement of amendment Act to the Danish Chemicals Act Notification according to Directive 98/34/EF as amended by Directive 98/48/EF j f m a m j j a s o n d j f m a m j j a s o n d Internal preparation (legal and technical issues) Preparation of ministerial order Public hearing of Public hearing of ministerial order amendmend to chemicals act Ministerial order entering into force Reactions on public hearing and policy process j f m a m j j a s o n d j f m a m j j a s o n d First year of registration 30/8: Deadline for registration The Danish Environmental Protection Agency PAGE 5

6 Danish Ministerial order no. 644 of 13/06/2014 Unofficial translation on: The ministerial order as notified according to the 98/34 procedure (Reference 2013/603/DK) The Danish Environmental Protection Agency PAGE 6

7 Purpose and scope of the nanoproduct register 1. The purpose of this Order is to establish a register of mixtures and articles that contain nanomaterials (nano products) and which are intended for sale to the general public, as well as require producers and importers of these mixtures and articles to report to the nano product register information on said mixtures and articles and the nano materials they contain. 2. The reporting requirement to the nano product register includes mixtures and articles that are intended for sale to the general public and which contain nanomaterials, where the nanomaterial itself is released under normal or reasonably foreseeable use of the mixture or article or where the nanomaterial itself is not released but substances in soluble form that are classified as CMRs or environmentally dangerous substances are released from the nanomaterial; except as provided for in 3. The Danish Environmental Protection Agency PAGE 7

8 3. Excemptions 1. Foodstuffs and food contact materials. 2. Feed. 3. Medicinal products. 4. Medical devices. 5. Cosmetic products. 6. Pesticides. 7. Waste. 8. Nanomaterials listed Annex IV or V of REACH (Natural substances). 9. Not intentionally produced at the nanoscale. 10. Nanomaterial is part of and not released from a fixed matrix 11. Articles or their labels on which the nanomaterial is used directly as ink, in newspapers etc. 12. Textiles with nanomaterial used as ink or for dyeing. 13. Paint, wood preservative, glue and filler that contains nanopigment added solely for colouring the mixture. 14. Articles of rubber, or rubber parts of articles, that contain the nanomaterials carbon black The Danish Environmental Protection Agency PAGE 8 or silicon dioxide

9 Our definition of mixtures and articles (products) Does the product contain nanomaterials? Basis is the recommended definition (2011/696/EU) yes Is the nanomaterial released from the product? yes is the nanomaterial a natural substance According to REACH annex IV-V yes Intentionally produced in the nanoscale yes Other excemptions? The Danish Environmental Protection Agency PAGE 9

10 Arguments for exemptions were typically: Information on the product available in other registers (in REACH, Danish Product register, etc.) Products regulated with an approval procedure (pesticides, medicinal products, etc.) Natural products and substances not intentionally produced in the nanoscale The Danish Environmental Protection Agency PAGE 10

11 What should be registered? Mandatory Information on company: ID#, adress, contact person etc. Productinformation: name, amount, use, professional use (Y/N) Information on the nanomaterial: Name, REACH-registration, occurrence in product Chemical information: IUPAC, CAS no., EU-number, formula Voluntary REACH: Use descriptor categories (PC, PROC. ERC, AC) Content of nanomaterial: in product or mixture (gram or %) Physical information on nanomaterial: particle size, number size distribution, aggregation, agglomeratino, form, specific surface area, crystalline state, surface chemistry, surface charge The Danish Environmental Protection Agency PAGE 11

12 Physical information on the nanomaterial 1. Particle size 2. Numerical size distribution 3. Aggregation 4. Agglomeration 5. Form 6. Specific surface area 7. Crystalline state 8. Surface chemistry 9. Surface charge The Danish Environmental Protection Agency PAGE 12

13 Important features/characteristics Registration is mandatory - not all information Registrants are those introducing the nanoproduct to the Danish marked Registration is not triggered by hazards or risk of nanomaterials Registration of similar technical information as BE, FR & IT Possible to register same endpoints as in OECD harmonized Templates (OHT), but not mandatory Re-use of information from the Danish product register Data only available for authorities and registrant (own data) The Danish Environmental Protection Agency PAGE 13

14 Practical registration Access via portal for all business registrations to the authorities in DK The Danish Environmental Protection Agency PAGE 14

15 Product information Year The Danish Environmental Protection Agency PAGE 15

16 Guidance and help for registrants Guidance in Danish and English ( Should I register my product (nano or not?) 18 illustrative examples of products How to use IT-system? Example of letter to supplier List of common nanomaterials List of product-groups that may be subject to registration FAQ on Help-desk The Danish Environmental Protection Agency PAGE 16

17 Confidentiallity Same level of confidentiality under REACH (and for the Danish product registry) This means that only if registrations from a limited number of registrants is available, then no reporting of average data etc. Legal expert assessed all data to make clear what information we could inform about. The Danish Environmental Protection Agency PAGE 17

18 What is registeret during the first year Eight companies have reported 117 products The products comprises of building materials and consumer products. The amounts registered can not be reported 101 of 117 products are used both professionally as privately the rest only privately 29 products are imported the remaining 88 are either produced in Denmark or with no information None of the registrants have used the option of referring to previous registrations on the national product register 10 different substances have been reported in the nanomaterials The Danish Environmental Protection Agency PAGE 18

19 Summary Overall purpose to establish overview of nanoproducts in DK Registration of nanoproducts (not nanomaterials) Registration not based on risk Only products imported DK or produced in DK Registration is mandatory Technical information as for BE, FR and IT Ministerial order published June products registered the first year of registration (20/ to 20/6-2015) The products comprises of 106 building materials and 11 consumer products The Danish Environmental Protection Agency PAGE 19