Nanomaterjali taħt ir-Regolament dwar il-Prodotti Bijoċidali
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REACH
- Nifhmu lil REACH
- L-Identifikazzjoni tas-Sustanza
- Reġistrazzjoni
- Valutazzjoni
- Awtorizzazzjoni
- Restrizzjoni
- Komunikazzjoni fil-katina tal-provvista
- Sustanzi f'oġġetti fil-lista ta' kandidati
- Leġiżlazzjoni
- Ittestjar fuq l-annimali skont REACH
- Infurzar
- Sostituzzjoni b’sustanzi kimiċi aktar sikuri
- Nanomaterjali
- Valutazzjoni ta’ ħtiġijiet regolatorji
- PBT assessment
- Endocrine disruptor assessment
- Cooperation with authorities and stakeholders
- Sustanzi ta' tħassib potenzjali
Nanomaterjali taħt ir-Regolament dwar il-Prodotti Bijoċidali
In-nanomaterjali huma sustanzi kimiċi jew materjali li huma manifatturati u użati fuq skala żgħira ħafna. L-istrutturi tagħhom ivarjaw minn bejn wieħed u ieħor 1 sa 100 nm f'mhux anqas minn dimensjoni waħda.
Nanomaterjali għandhom karatteristiċi uniċi u aktar ippronunzjati meta mqabbel mal-istess materjal mingħajr karatteristiċi nanoskali. Għaldaqstant, il-karatteristiċi fiżikokimiċi tan-nanomaterjali jistgħu jvarjaw minn dawk tas-sustanza voluminuża jew partikoli ta' daqs akbar.
In-nanoteknoloġija qiegħda tespandi malajr. Għadd kbir ta' prodotti li fihom in-nanomaterjali diġà qegħdin fis-suq Ewropew (eż. batteriji, kisi, lbies anti-batteriku, kożmetiċi, prodotti tal-ikel). In-nanomaterjali joffru opportunitajiet tekniċi u kummerċjali, iżda jistgħu jippreżentaw riskji għall-ambjent u jqajmu tħassib fejn jidħlu s-saħħa u s-sigurtà għall-bnedmin u l-annimali.
- 50% jew aktar tal-partikoli għandhom daqs ta' 1-100 nm f'mhux anqas minn dimensjoni waħda
- Il-partikoli huma fi stat mhux marbut jew bħala aggregat jew agglomerat
Monitoraġġ u rappurtar
ECHA
- How to prepare registration dossiers covering nanoforms [PDF] [EN]
- Guidance for identification and naming of substances under REACH and CLP [PDF] [EN]
- ECHA Guidance on Information Requirements and Chemical Safety Assessment for nanomaterials:
- Appendix to Chapter R.6: Guidance on QSARs and Grouping of Chemicals [PDF] [EN]
- Appendix to Chapter R.7a: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.7b: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.7c: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.8: Characterisation of dose [concentration] - response for human health [PDF] [EN]
- Appendix to Chapter R.10: Characterisation of dose [concentration] - response for environment [PDF] [EN]
- Appendix to Chapter R.14: Occupational exposure assessment [PDF] [EN]
- Template to document practical constraints for fulfilling REACH Annex VII and VIII information requirements [PDF] [EN]
OECD
- Registering nanoforms: practical advice – 2020 | Webinar Q&A
- Getting ready for revised REACH information requirements for nanoforms – 2019 | Webinar Q&A
- Updated REACH Guidance for nanomaterials - what you need to know – 2017
- How to ensure the safe use of nanomaterials under REACH - Part III: current best practices for human health and environmental exposure assessment and risk characterisation for nanomaterials – 2014
- How to ensure the safe use of nanomaterials under REACH - Part II: Current best practices for human health and environmental hazard assessment for nanomaterials – 2013
- How to ensure the safe use of nanomaterials under REACH Part I – 2012
- Search for nanomaterials on the EU market
- ECHA Nanomaterials expert group
- EU nanomaterials observatory (EUON): Overview of REACH Annex modifications and available methods
- Group assessing already registered nanomaterials (GAARN) - meeting reports
News
- New OECD guidance documents for the risk assessment of nanomaterials, News release 27 July 2020
- Companies need to provide more data on nanoforms, News release 24 February 2020
- Updated guidance for registering substances in nanoform, News release 3 December 2019
- Get ready for new REACH requirements for nanomaterials, News release 8 October 2019
- Companies to provide more information on nanomaterials, Press release 3 December 2018