what are the key components of REACH?
Under REACH, each legal entity manufacturing or importing chemicals in volumes of one ton or more per year will have to register them with the European Chemicals Agency (ECHA). ECHA which was established in Helsinki in 2007 is responsible for managing the REACH processes.
In order to benefit from the phased registration deadlines (2010, 2013 and 2018) and to allow continued manufacture or import in quantities >1t/yr, each EU manufacturer or importer was required to pre-register each substance with ECHA by Dec 1st 2008.
The pre-registration period is now closed and only Companies manufacturing or importing for the first time may now benefit from the provisions of late pre-registration. If you do not meet the requirements for a first time manufacture or import you must complete and submit an appropriate registration dossier prior to manufacturing or placing the product on the EU market.
Only EU companies are permitted to register directly with ECHA. Non EU manufacturers can however choose to appoint an EU based legal entity to represent them as an Only Representative (OR). The OR then assumes all importer obligations under REACH. In the absence of an OR the registration obligation for non EU manufactured substances has to be fulfilled by the EU importer established within the European Union. Operation of OR’s is one of the most complex aspects of the REACH regulation and professional guidance should be sought on this subject.
Following the conclusion of pre-registration, potential registrants (including downstream users & third parties) of the same substances are participants in Substance Information Exchange Fora (SIEFs). SIEF’s are intended to facilitate:
Depending on the volume band and the classification of the substance, one of three registration dates will apply (Nov 2010, June 2013 or June 2018). Managing the activity related to registration will be an intensive effort and should not be underestimated.
If manufactured or imported volumes exceed 10 t/y, a Chemical Safety Report (CSR) will have to be submitted as part of the registration dossier. In preparing the registration dossier, companies will be expected to use and share existing data. Producers, importers and downstream users will also have to pass information up and down the supply chain.
Following submission of the registration dossier, ECHA has three weeks to check completeness. However, for registration dossiers of phase-in substances submitted in the last 2 months before registration deadlines, ECHA has 3 months from the relevant deadline to check completeness.
Once the registration is complete a registration number and a registration date for the substance will be provided to the registrant.
After Registration, ECHA will perform dossier evaluation to assess the testing proposals made by registrants or to check the compliance of the registrations dossiers. ECHA will also coordinate substance evaluation which will be conducted by the Member States to investigate substances of concern. As part of this exercise they may conclude that:
Selected substances deemed to be of very high concern to human health and the environment will be subject to authorisation by ECHA. These substances include:
The authorisation process will include an assessment of whether risks are adequately controlled, whether a suitable alternative exists and whether the socio-economic benefit of continued use of a substance may outweigh the risks associated with its use. The assessment may lead to an outright or selective ban on use of a substance in a particular end use application.
On October 28, 2008, ECHA published the ‘first Candidate List of substances for Authorisation’. The list is updated with additional Substances of Very High Concern (SVHC) twice per year. The publication of the ‘Candidate List’ is the first step to identify priority substances to be formally subject to Authorisation. First update of the list of substances subject to Authorisation (Annex XIV) was done on February 17. Further information on the presence of Candidate List substances in ExxonMobil products can be found at the following link: ExxonMobil response to candidate list