Substance proposed for Restriction under REACH Is substance

Substance proposed for Restriction under REACH Is substance already in Ro. HS? No Yes Did Ro. HS review consider HH & the Env? No Yes REACH should exclude EEE from the scope of the REACH application for restriction indicating that the use of the substance in question in EEE is restricted by the Ro. HS Directive Ro. HS review methodology may be adapted to take account of risks to HH/Env during the Mfg and use phases of EEE lifecycle. Options 1. Impose restriction under REACH and later amend to carve out EEE if/when substance is added to Ro. HS. 2. If the restriction is specific to EEE, use REACH procedure to prepare an amendment to Ro. HS outside of the normal Ro. HS periodic review (~ every 4 years)

Substance proposed for Authorization under REACH Is substance in Final Product? No Yes Is substance already in Ro. HS? No Yes Are there Ro. HS Exemptions for the substance? Yes No Can’t place product on EU Market, but can still incorporate the substance into EEE and sell to external market. Therefore REACH Authorization requirements would apply. Options 1. If use of substance under Ro. HS is covered by Ro. HS Exemptions, the act of incorporating the substance into EEE by EU companies is still subject to REACH Authorization requirements. It’s possible that exempted uses by Ro. HS could exempted by REACH pursuant to Article 58(2). 2. A case-by-case analysis may conclude that an exempted Ro. HS use does not constitute “proper control” for the purposes of Article 58(2) of REACH. If a substance was included in the Authorization process due to this concern, the Authorization requirements would only apply to EU companies, not to EEE imported from outside the EU. Consequently, there would be an additional burden for EU companies until the Ro. HS exemption expired. Options 1. Include substance in Annex XIV , exempt the act of incorporating the substance into EEE later (unless there are good reasons for maintaining the Authorization requirements, once Ro. HS affords proper control of the risks. 2. Delay the REACH procedure pending inclusion of the substance into Ro. HS. If Ro. HS procedures are begun early enough and concluded in time, it will be possible to consider exempting the use of the substance in EEE from the Authorization requirements. Companies able to justify the continued use of an SVHC can apply for general exemptions under Ro. HS, rather than individual authorizations under REACH. Ro. HS would not cover this use, so REACH Authorization requirements would apply.

Substance proposed for regulation under Ro. HS Is the substance restricted in REACH? Yes No Are all uses of the substance restricted in REACH? Ro. HS need not look at this substance, as its use is already restricted by REACH. No Is the proposed Ro. HS restriction => than REACH restriction? Is the substance authorized in REACH? Yes Yes Substance may have no exemptions under REACH Authorization, since there was no Ro. HS restriction at the time of Authorization. REACH Annex XVII should be amended to remove EEE from the scope of the restriction, and the entry in Annex XVII should be amended to show that the use of the substance in EEE is restricted by the Ro. HS Directive. Will there be Ro. HS exemptions for the substance? No No Substance can be restricted under Ro. HS Directive. Yes The act of incorporating the substance into EEE by EU companies is still subject to REACH Authorization requirements. It’s possible that exempted uses by Ro. HS could exempted by REACH pursuant to Article 58(2). Need to consider whethere is added value in continuing the authorization requirements under REACH for those exempted Ro. HS uses. The results as well as the information derived from the authorization process in REACH could give good indications whether to provide for exemptions in Ro. HS. Authorization requirements apply to companies incorporating the substance into EEE. Any authorizations under REACH become redundant, probably at the beginning of the expiry of the first authorization period set by the review clause in REACH.