Nanoforms: new requirements for reach
EU regulation (EU) 2018/1881 is amending reach to address nanoforms of substances in the registration dossier. Since 1 January 2020, companies must provide additional information on nanomaterials for all registrations, when applicable. The information to be provided includes:
- characteristics of nanoforms or nanoform sets,
- chemical safety assessment addressing the nanoform hazard
- dossier information requirements,
- downstream user obligations.
Depending on manufacturing methods, nanoforms may differ in size distribution, surface shape and chemistry. These characteristics can affect the behaviour and reactivity of each nanoform.
TECHNICAL SERVICES
REACH Monitor offers regulatory assistance for companies in the preparation of the registration dossier of a nanoform required by reach regulation. [please see: registration]
for the REACH registration we can assist :
- nanoform identification by analysis of the different parameters
- substance sameness profile
- determination of the (eco)toxicological profile hazards of nanoforms
- risk assessment for nanoforms
MANAGEMENT SERVICES
REACH Monitor offers a wide range of technical assistance for joint submissions, at all stages for individual companies and consortiums. The managing officer is a qualified technician who works together with the toxicologist tem. Learn more about consortium management services.
R&D
REACH Monitor offers a service for research and development for companies willing to launch specific projects for product improvement, reformulation or new property search.
MICROPLASTICS
Microplastics are very small particles of plastic material (usually less than 5 mm) that can be formed involuntarily by wearing out larger pieces of plastic, such as synthetic textiles. They can also be deliberately manufactured and added to products for a specific purpose, for example, as exfoliating particles in facial or body scrub creams. Once released into the environment, they can be accumulated by animals, including fish and shellfish and, consequently, consumed as food.
ECHA planned a timetable for the proposed restriction of intentionally added microplastics, scheduled for 2018-2022. If agreed, the adopted restriction is scheduled for 2022, but for certain applications some transitional periods are proposed.
TECHNICAL SERVICES
REACH Monitor offers a comprehensive service for the evaluation of the regulatory implications on the commercialization of substances and products due to the proposal of restriction of intentionally added microplastics (Annex XV of reach).
the assessment includes different stages as:
- microplastics definition criteria applicability,
- criteria of solid particles of relevant size, polymer criteria, criteria of polymer containing particles, determination of the concentration,
- verification of the applicability of exemption for different uses.
Contact reach monitor for advice on microplastics regulatory framework. contact form.
