REACH is a complex and far-reaching regulation that will require companies to review their chemical portfolios. It extends rigorous data and assessment requirements to substances, products and certain articles whose production/import exceeds 1 metric tonne (MT) per year. In addition, polymer producers outside of the EU are required to ensure that their monomers and other constituents over two per cent are registered under REACH.
What does REACH require?
- Registration of all existing chemicals (unless explicitly exempted) by the end of 2018
- Registration of high tonnage and certain high concern chemicals (unless explicitly exempted) must now be registered prior to use or import
- Registration of every producer or importer of greater than 1 MT per year unless explicitly exempted
- The development of standardized dossiers detailing physicochemical, toxicological, exposure and production information on each chemical and producer/importer and identified chemical use
- Data requirements, tiered according to volume or classification, including physical, chemical, toxicological, environmental and use pattern data
- Integration of exposure and environmental release data up and down the supply chain
- Identification, notification, and potential authorization and restriction of uses for designated substances
- Mandated data sharing for joint submissions (via Substance Information Exchange Forums or SIEFs) and the reduction in the use of vertebrate test organisms
- Maintenance of production and testing data files in the EU that are open to ECHA review upon request
- Authorization applications for carcinogenic, mutagenic, and reproductive toxins (CMRs) within the candidate list