Regulatory requirements
REACH is the comprehensive European Union regulation (EC 1907/2006) for Registration, Evaluation, Authorisation, and Restriction of Chemicals, effective since June 1, 2007.
The EU REACH Regulation (EC 1907/2006) adopted in June 2007 is a hallmark chemical regulation imposing obligations on the entities placing chemical substances into the European Economic Area (EEA), to collect and assess information on the substance in order to identify and manage the associated risks.
The vast scope of REACH regulation concerns a range of sectors and companies generally considered as either manufacturer, importer or downstream user with each having different levels of responsibilities under the regulation to comply with.
These requirements include:
- Registration of substances which are produced or imported in volume ≥ 1 t/annum. For ≥ 10 t/annum an additional Chemical Safety Report is required.
- Notification to ECHA and customer/consumers for Substance of Very High Concern (SVHC) with >0.1% mass percent (w/w) in articles containing such substances
Beside REACH Regulation, several other regulatory frameworks may have to be considered depending on the product:
- The CLP Regulation (EC) No 1272/2008 (Classification, Labelling and Packaging)
- Substances registered as biocidal active ingredients are regulated under the Biocidal Products Regulation (EU) No 528/2012 (BPR) and are considered registered under REACH. However, substances with multiple uses, quantities outside Biocidal use and co-formulants have to be registered under REACH.
- Analogous to Biocide active substances, Plant protection active substances are considered as registered under REACH, because Regulation (EC) No 1107/2009 provides a complete risk assessment. Co-formulants, and uses outside PPP-use, have to be registered under REACH.
- REACH Regulation applies in general to cosmetics, but some REACH restrictions may defer to cosmetics rules of Cosmetics Regulation (EC) No 1223/2009:
- The Detergents Regulation (EC) No 648/2004 applies in addition to REACH Regulation; while substance registration and hazard data is regulated under REACH, the Detergents Regulation sets rules for (e.g.) biodegradability requirements, ingredient disclosure, product-specific requirements.
Other regulations may apply depending on the use, purpose, and nature of the chemical to be registered.
REACH Registration Process
The timeline is a rough estimate and depends on the complexity, data availability, and SIEF negotiations. It can be faster or significantly slower.