1. An "Only representative" must make separate pre-registration submissions for each company they are representing for each chemical; joint submissions for each chemical covering more than one company are not permitted.
2. Biocides and pesticides will require registration if the chemical is not being used as a biocide or pesticide.
3. Polymers do not require notification providing the monomer level does not exceed 2%. But individual monomers used to manufacture the polymer must be notified and where the polymer tonnage increases sufficiently to cause the monomer usage to enter the next tonnage bracket.
4. Isolated intermediates: On-site isolated intermediates. A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances if they are not otherwise exempted from registration. However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the REACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3). Transported isolated intermediates. A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration. However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) of the REACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4). In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
5. If a substance is not pre-registered by 1st December 2008, the chemical producer must stop any sale or production within the EU immediately after that date until the substance has been registered. Any of that substance made between 1st June and 1st December 2008 must not be sold after that date.
6. Where an article is manufactured and there is a release of a substance of greater than 1 tonne per year pre-registration is necessary, for example digital ink cartridges.
7. The downstream user (DU) should not normally pre-register but it may be necessary if a substance is critical to their process, the DU requires the usage to be remain confidential or there is no registrant committed to pre-registration.
8. The DU should check whether the supplier is pre-registering. Late pre-registration is a possible option as is purchasing from an outside EU supplier of less than 1 tonne /annum. Greater than that quantity the important would become the registrant,
9. The estimated cost to produce the necessary best set test information for substances greater than 1000 tonnes per annum is €250,000 to €280,000 plus €31,000 for registration.
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