UK Presidency compromise
- More exemptions from registration for waste, substances needed in the interests of defence, minerals and ores.
- Single six-month pre-registration period for existing substances starting 12 months after regulation enters into force.
- More room to opt out of "one substance, one registration" (OSOR) requirements if the cost would be disproportionate; where there may be a breach of confidentiality; and in case of disputes over selection of information to be presented. Justification has to be given. Animal test data must be shared; sharing of non-animal test data also mandatory if requested by one potential registrant.
- For new or existing substances produced at 1-10 tonnes per year, full test data specified in Annex V will only need to be supplied for substances suspected to be carcinogenic, mutagenic or reproductive toxins (CMR); those defined as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or those that may be classified as dangerous under EU law and that are in dispersive uses, particularly consumer articles. The earlier compromise text also included substances for which inadequate risk data are available (ENDS Report 368, pp 33-34).
However, continuing debate amongst national officials over these criteria may mean that the final decision will be passed on to the European Chemicals Agency.
- Requirements for costly reproductive toxicity screening tests for 10-100 tonnes per year substances are also reduced; with more scope to waive on the basis of inadequate human exposure.
- A requirement for manufacturers or importers to notify the Agency if articles contain authorisable substances, even if these are not intended to be released, has been watered down. Companies need not do this if they can show steps have been taken to limit human exposure. Controversially, supplying instructions for appropriate use would count as such a step.
- The Agency will have even more powers to decide the substances to be evaluated by member states. NGOs fear this will lessen their ability to investigate substances of concern.
- The ability of companies to be able to claim that the risks from substances of very high concern are adequately controlled in order to continue selling them will not be applicable to PBT or vPvB substances. NGOs continue to argue that "adequate control" is unworkable, particularly for substances like endocrine disrupters which may have additive effects.
Authorisation is permissable for chemicals of concern even where their risks are not adequately controlled, but companies must now submit an analysis of possible alternatives as a condition of their request being considered.
MEPs' compromise on registration
- Pre-registration of existing substances 18 months after entry into force of the Regulation. Further six months possible for SMEs and downstream users. Agency to establish database of pre-registered substances.
- Greater registration priority for PBT, vPvB substances in accordance with earlier Presidency text.
- Narrower definitions of existing or "phase-in" substances.
- For existing 1-10 tonne per year substances, the MEPs have proposed only slightly different criteria to define those that must supply full risk data: those that may be CMR, PBT or vPvB; or those classified as dangerous to humans or the environment and that are intended for consumer or professional, rather than industrial use, or intended to be released from consumer articles.
- Screening test for reproductive toxicity for 10-100 tonne per year substances removed; developmental toxicity test only required for higher tonnages.
- Exposure-based waiving is introduced for specific tests for substances at all tonnages. The Commission is given powers to decide on the justification for exposure-based waiving.
- Uses described in chemical safety reports to be categorised as industrial, professional, or for consumer use, with sub-categories to define exposure patterns.
- Data protection rights for companies' risk assessment studies are extended from 10 years to 15 years.
- Greater role for Agency on substance evaluation plans.
- Similar opt-outs proposed from OSOR as in Presidency text.