LONDON (ICIS)--The EU's Reach chemicals registration and authorisation project passed another major milestone at the end of June when close to 3,000 more chemicals were registered with the bloc's chemicals agency in Helsinki.
The second registration deadline for Reach passed by relatively smoothly. It was for substances sold in the EU in quantities less than 100 tonnes/year. The first Reach registration deadline in November 2010 swept up chemicals sold in the EU in volumes of more than 1,000 tonnes/year as well as some lower tonnage products.
On the face of it this suggests that producers and other sellers on the European market have come to understand the Reach process and are ready to comply with its requirements.
Under Reach, the EU operates a 'no data, no market' policy which requires sellers to provide extensive sets of data on the substances they deal in.
But some do to a greater or lesser extent - or it may be that some understand the Reach process - better than others.
An ECHA report made public on 6 September highlighted some of Reach's shortcomings, particularly the pressure it has put on smaller players to comply with the rules.
Chemical producers and downstream users rely heavily on safety data sheets (SDS) to successfully manage workplace and product health and safety. But the ECHA report suggested that there are significant shortcomings in the consistency of the data logged on those sheets.
Of greater concern has to be the fact that smaller companies and formulators operating within some product supply chains do not really understand the (legal) requirements of Reach - and the EU's parallel classification labelling and packaging (CLP) rules.
The proportion of companies in a sample of 1,181 enterprises of all sorts that "violated provisions of the chemicals legislation to various extents of concern" was 67%, the ECHA said.
"Non-compliance included registration and notification contraventions, failing to sufficiently provide information on hazardous chemicals downstream and deficient implementation of risk management measures," it added.
The registration and data requirements under Reach affect producers and users of chemicals in the EU and also anyone who wants to sell into the EU market. The EU chemicals control scheme is also being used as a model for legislation in other countries such as Japan, South Korea and India.
Concern about non-compliance was expressed earlier this year at a Reach forum held in Helsinki.
Questions were asked then about non-compliance and the ability of the ECHA to actually monitor Reach given the new wealth of data.
Professor of regulatory toxicology and ecotoxicology at Stockholm University, Christina Ruden, said that the significance of shifting the responsibility for chemicals safety to the industry may not be widely appreciated.
"It is a total paradigm shift to put the whole responsibility for testing and safety of chemicals on the entity that actually has the economic advantage of selling [the chemicals]. I'm not sure that everyone is aware of the revolution this implies."
The latest ECHA study suggests that many are finding it difficult to follow the letter of the law even though most chemical companies have a deep understanding of the chemicals they produce and their potential for harm.
The study was carried out by 29 EU member states with inspections lasting a year. Checks at 1,181 enterprises were made on 6,900 substances, 4,500 mixtures and 4,500 safety data sheets. Downstream small- to medium-sized enterprises (SMEs) were checked as were manufacturers, importers and `only representatives', the legal representatives of importing companies.
More than half (52%) of the safety data sheets showed defects, the ECHA said, and the correspondence between information on the safety data sheet and on the product label was deficient for 24% of the inspected companies.
The results overall are better than those from an earlier Reach enforcement study but the agency makes some recommendations that industry will need to be pursue.
"Awareness and knowledge on Reach among smaller downstream-user companies is sometimes very low or even non-existent," it said. "This is a matter of concern and should be monitored."
Companies can check on their obligations under Reach and the CLP rules from national helpdesks or the authorities that monitor Reach compliance in those countries. But there does seem to be room for more training and cooperation among authorities at the national level to help raise the level of Reach and CLP understanding.
The onus is on industry participants, nevertheless, to fully understand how these regulations apply to them. And to put into action the processes that will help them comply with the still relatively new rules.
1. http://www.icis.com/Articles/2013/09/04/9702942/67-of-downstream-users-non-compliant-with-echa-chems-rules.html 2. http://www.icis.com/Articles/2013/06/18/9679694/scrutiny-criteria-for-echa-reach-dossiers-inadequate-academic.html
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(Originally published Sept. 11, 2013, in Chemical News & Intelligence.)