Companies are producing and using chemicals more safely “whilst innovation continues and the competitiveness of industry is maintained”, says the head of Echa.
In his introduction to the agency’s second five-year report on the operation of REACH and the CLP Regulation, executive director Geert Dancet says the agency “has moved from a data-gathering organisation to a knowledge management one”. With more than 54,000 registration dossiers for 14,000 substances published on its website, REACH and CLP, he says, “are unequivocally leading to a safer Europe. Citizens can now easily find out about the hazards of the chemicals they use.”
But more, he says, needs to be done to improve the quality of information in registration dossiers and ensure information flows along supply chains.
And he also warns that many companies that will need to register low-volume substances by 2018 have not yet started their preparations.
The poor quality of some of the data in dossiers is limiting its usefulness and “almost delaying the real transfer of the burden of proof which was a driving principle behind REACH” because it “remains with the authorities to show that a company has not taken their responsibility under the law to describe their substance and its effects clearly enough.”
REACH requires registrants to update their dossiers whenever there is a material change, or where new information comes to light. However the report says it is not being done consistently enough and “this is the most significant barrier to be overcome in terms of reaching the objectives of the legislation. It also leads to wasted time and inefficiencies in member states, the European Commission, Echa and in companies themselves”.
An implementing Regulation should be considered to ensure mandatory reporting of use and exposure information according to a binding timeframe for regular updates
To address this, Echa says an implementing Regulation should be considered to ensure mandatory reporting of use and exposure information according to a binding timeframe for regular updates.
Also, the Commission and trade bodies should work with it “to ensure that the rules and mechanism concerning joint registration and data-sharing are sustained after the last deadline, when the substance information exchange fora (Siefs) formally cease to operate”. This is needed to avoid uncertainty among potential registrants, especially for existing substances, as it is likely that new manufacturers and importers will emerge in the years to come.
To help avoid unnecessary animal testing, the Commission should “consider provisions for obligatory data-sharing between analogue substances for read-across and category purposes”.
Changes to the information requirements for nanomaterials – originally expected two years ago – are “urgently needed”, says Echa. Some companies, “are holding back on providing nano data because there are no explicit information requirements in REACH. But it is only a matter of time before these come, and waiting for that to happen, or resisting requests for information until there is legal clarity, is not helpful. It results in lost time and wasted energy for all involved and may affect human health and the environment. Whilst we await clear information requirements from the Commission, a constructive approach by industry to providing data on nanos would be welcomed.”
Low-volume substances and polymers
As part of its consideration of whether to extend the obligation to prepare a safety assessment to low-volume substances (1-10 tonnes/year), the Commission should consider reviewing the information requirements for substances classified as CMRs or other substances of concern. Similarly, it should consider including polymers within the scope of registration.
The Commission should change the CLP Regulation to oblige notifiers and registrants to share data and to resolve any unjustified differences and to make notifications time-limited
The fact that contradictory self-classifications remain in the classification and labelling inventory five years after it was established “needs to be resolved”, the agency says. “It is not at all helpful – not least to downstream users or consumers”. And to do this, the Commission should “change the CLP Regulation to oblige notifiers and registrants to share data and to resolve any unjustified differences and to make notifications time-limited.”
Safety data sheets
Only a small proportion of SDSs have adequate exposure scenarios for all the uses made of the substance, says Echa, making the risk management of chemicals in manufacturing companies more difficult. Downstream users should help themselves by demanding “better quality, user-friendly” safety data.
SVHCs in products
A “fundamental review” of the obligation on companies to notify the presence of SVHCs in articles is needed because the number of notifications “remains worryingly low”. Importers “need to take their responsibilities seriously – they are responsible for knowing what they are importing into the EU, what the effects of their products could be on consumers and for notifying Echa.”
Authorisation and restriction
Although the Commission says it has lifted its moratorium on adding substances to the authorisation list, Echa asks it to “provide further transparency” on its plans for those substances Echa has recommended for inclusion.
The Commission and member states should decide whether restrictions could have a wider scope, both in terms of the number of substances covered, and the number of uses.