The vast majority of obligations under REACH apply to manufacturers and importers of substances in the EU.
The REACH processes relevant for manufactures and importers are:
Manufacturers and importers of substances must submit a registration to the Agency for each substance manufactured or imported in quantities of 1 tonne or above per year. Failure to register means that the substance cannot be manufactured or imported. Producers and importers of articles need to pre-register and register substances which are present in their articles in quantities over one tonne a year and if those substances are intended to be released. For these cases, the same registration obligations as for manufacturers and importers of substances apply in analogy.
Registrants wishing to use the phase-in provisions will be required to pre-register to the Agency to permit sharing of available information (data sharing). Registrants will be required to share data gained by vertebrate animal testing.
Registrants are required to update their registrations on their own initiative as soon as the quantity of a substance reaches the next tonnage threshold and/or when relevant new information becomes available.
If an article contains a substance of very high concern (≥ 0.1% w/w) which has been placed on the candidate list for authorisation there is an obligation to notify the Agency. This requirement applies if the substance is present in the article produced or placed on the EU market in quantities of 1 tonne or more a year and exposure to humans or the environment cannot be excluded. The obligation will apply from 1 June 2011 at the earliest (or six months from the date the substance has been placed on the candidate list, in case the substance has not been on the list before 1 December 2010).
Manufacturers and importers must notify to the Agency the classification and labelling of all substances subject to registration or classified as dangerous (Art. 1 of Directive 67/548/EEC) and placed on the EU market. The Agency will include the notified substances in the Classification and Labelling Inventory.
REACH will replace the current Safety Data Sheets Directive. The SDS requirements and responsibilities for manufacturers and importers will remain and be extended by the requirement to convey information from any relevant chemical safety assessment.
When a chemical safety assessment is performed (substances placed on the market in quantities ≥ 10 tonnes per year by a manufacturer or importer), exposure scenarios must be developed for dangerous substances and PBT/vPvB_substances. These exposure scenarios shall be placed in an annex to the Safety Data Sheet. The exposure scenarios contain a description of the risk management measures which the manufacturer or importer has implemented and recommends downstream users to implement. For this purpose, manufacturers or importers must assess all uses that are identified to them by their downstream users. If they decide not to support a particular use, they must justify this and notify the Agency and their downstream user.
Producers or importers of articles containing a substance of very high concern (≥ 0.1% w/w) which has been placed on the candidate list for authorisation must supply sufficient information to allow safe use of those articles to industrial and professional users. To consumers this information must be provided on request. In addition, the same information obligations as for manufacturers and importers of substances apply in analogy for substances in articles intended to be released.
An authorisation is required for uses and placing on the market of substances included in Annex XIV of the REACH Regulation. An authorisation can be requested by manufacturers, importers or downstream users on their own or in collaboration with other actors in the supply chain. Importers of articles are not required to apply for authorisation even if the article contains a substance included in Annex XIV.
Applicants for authorisation have to demonstrate that the risks from their uses are adequately controlled or that the socio-economic benefits outweigh the risks, in cases where there are no suitable alternative substances or processes.
Manufacturers and importers and their customers must comply with the restrictions listed in Annex XVII of the REACH Regulation.